ihe sept oct2010

The Magazine for healThcare decision Makers

Also in this issue

HIFU in prostate cancerTriple negative breast cancer (TNBC)LESS and NOTES: recent trends in urological surgery

Weekly news updates on www.ihe-online.com

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Equipment & solutionsVolume 36

IHE Sept./October 2010

iNtENsiVE CaRE spECialStrict or loose glycemic control in critically ill patients?Nurse staffing level standards in CCUs

image-guided radiotherapy and radiosurgery

Page 30

contrast enhanced spectral mammography

Page 32

solid state detector for aec-equipped X-ray systems

Page 33

www.ihe-online.com & search 45527

The long-awaited decisions on the fate of the diabetes drug Avandia were finally announced late September by the drug authorities

on either side of the Atlantic (the FDA in the US and the European Medicines Agency, EMA in Europe). Access to the drug will be severely restricted in the United States, and it has been sim-ply withdrawn completely from the market in Europe. Far from ending the long-running Avandia story, the regu-latory decisions however look set to open up a new debate on the very abil-ity of the drug regulatory authorities to handle cases where the risk-benefit ratio is finely balanced. Marketed by Glaxo Smith Kline, Avandia, whose active ingredient is rosiglitazone, is one of two drugs (the other being pioglita-zone marketed as Actos) in a unique therapeutic group. This is the class of thiazolidinediones which are used as antidiabetic agent and indicated as an adjunct to diet and exercise as a sec-ond line drug to improve glycemic control in adults with type 2 diabetes mellitus. Thiazolidinediones reduce the blood levels of glucose and fatty acids by sensitising cells to insulin, and function by binding to the peroxi-some proliferator-activated receptors (PPARs), which in turn affects gene expression. The drugs have very com-plex biological effects as they can result in the up-or down-regulation of mul-tiple genes. Ever since its introduction, rosiglitazone has been recognised as being associated with fluid retention and an increased risk of heart failure. Data from clinical trials, observational studies and meta-analyses of other existing studies that have become available over the last three years have suggested a possibly increased risk of ischemic heart disease. In particular, a meta-analysis of controlled clinical trials found increases in the risk of myocardial infarction and a near sig-nificant increased risk of death from cardiovascular causes when compared to standard diabetes drugs. One prob-lem however is the fact that each of the data sources behind this conclu-sion has its limitations, including the potential for bias in observational studies not to mention the fact that

pooling of data from different studies that were not designed to assess car-diovascular risk in the first place can lead to invalid conclusions. The data are still being debated, with some cli-nicians arguing that the drug should be retained, particularly in cases where other drugs have been less success-ful. As the Commissioner of the FDA herself put it, some diabetes patients cannot tolerate other diabetes medi-

cations and in such cases the drug is important for them. Reflecting the lack of clear-cut evidence one way or another, the rosiglitazone controversy is thus special because there are dia-metrically opposed positions regard-ing the risk/benefit ratio of the drug. Such diverging views are strongly held, not only by expert advisers to the regulatory bodies, but also in the bio-medical community as a whole.

Some commentators even go so far as to suggest that in cases such as Avandia where even the experts are divided, the regulatory authorities should not even attempt to judge the data but leave the final decision as to whether to prescribe the drug to the treating clinician.

Risk/benefit assessment – getting it right

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EditoR’s LEttER 3 – September/October 2010

Visit us at Medica 2010Hall 9 - Stand C41

ContentsFRONT COVER PRODUCTS[30] image-guided

radiotherapy and radiosurgery

[32] Contrast enhanced spectral mammo-graphy

[33] solid state detector for AEC-equipped X-ray systems

FEATURES[6 - 8] UROLOGY High-intensity focused ultrasound in prostate cancer treatment

[11 - 15] INTENSIVE CARE[11 - 13] Strict or loose glycemic control in critically ill patients?

Conflicting evidence.

[14 - 15] Standards for the level of nurse staffing in critical care units

[16 - 17] MEDICAL IMAGING Assessing the glucose metabolic phenotype of cancer using FDG-PET/CT

[18 - 19] IT CASE STUDY RIS/PACS development in the north of the Netherlands

[20 - 22] WOMEN’S HEALTH Triple negative breast cancer

[23 - 25] MINIMALLY INVASIVE SURGERY LESS and NOTES: applications in urological surgery

[28 - 29] HOSPITAL HIGHLIGHT High quality imaging in the Gulf Region

REGULARS[3] Editor’s letter

[10] News in brief

[26] Scientific literature review

[30 - 32] Medica 2010 preview

[33 - 34] Product news

Healthcare professionals are entitled to receive iHE’s digital edition for the next 12 months completely free of charge. to begin a new subscription or to continue your existing free subscription go to

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Equipment & solutions

CoMiNG UP iN JUNE 2010Cardiology specialPediatricsUltrasound

issN 0306-7904

CoMiNG UP iN NoV 2010Medical imagingPoint-of-careHospital hygiene

6 URoLoGY

HIFU technologyThe focused waves used in High Intensity Focused Ultrasound are emitted from an ultrasound transducer and are absorbed in the target area, causing limited damage to the surrounding tissue. Ultrasound studies and parameters for treating prostate conditions were defined in 1992, with Madersbacher being the first to develop a prototype instru-ment for benign prostatic hyperplasia in 1994, and for prostate cancer in 1995 [1]. The first use of the approach on organ-confined pros-tate cancer was described by Gelet in 1996 using the Ablatherm device [2], which was the first commercially available HIFU system, developed by the French company EDAP and introduced to the European market in 2001. The other device currently on the market, the Sonablate 500, originated at Indiana Univer-sity School of Medicine in Indianapolis, USA, and was developed by the US company, Focus Surgery of Indianapolis, Indiana, USA for the treatment of prostate cancer.

Although each of these systems uses high intensity-focused ultrasound to induce coagu-lative necrosis, there are technical differences between the two devices, such as differences in the imaging and therapeutic transducers, in the requirements for the position of the patient, and in the type of software used for treatment planning and safety monitoring.

HIFU treatment is generally administered in a day-surgery setting. Patients are anesthe-tized by epidural anesthesia with sedation or general anaesthesia. The HIFU probe, covered

by a condom or balloon, is manually inserted into the rectum and fixed. Degassed and cooled water is circulated within the rectum to cool the rectal wall and to eliminate acous-tic interferences between the transducer and the rectal mucosa, and the treatment is started after selection of the treatment zone. At the end of the procedure, a transurethral catheter or a percutaneous cystostomy is inserted.

Patients are generally discharged the day after treatment, and receive antibiotics and anti- inflammatory drugs for at least 14-21 days. The urine drainage system is removed as soon as possible.

ContraindicationsThe main and obvious contraindication to HIFU is accessibility. The procedure requires a transrectal approach, so all pathologic or anatomic conditions which prevent probe introduction are absolute contraindications; all patients with local rectal disease should be carefully excluded. Another relative contrain-dication is the presence of major intrapros-tatic calcification: the treatment is based on ultrasound and calcification acts as an acoustic barrier to the progression and diffusion of the ultrasound waves. Pre-operative trans-urethral resection of the prostate (TURP) can not only remove calcification, but can also remove a prominent median lobe and/or a large volume prostate, which are the other relative contrain-dications to HIFU.

Side-effects of HIFU treatmentThese have been extensively described. Imme-diate acute urinary retention is a normal effect

High-intensity focused ultrasound (HiFU) in prostate cancer treatmentProstate cancer is the cancer with the highest incidence in men and is the second cause of cancer mortality in industrialised countries. the introduction of PsA testing in clinical practice has increased the identification of patients with organ-confined prostate cancer, suitable for a curative approach.

Current management of localised prostate cancer can vary from surveillance only, expectant management to radical prostatectomy (with open, laparoscopic or robotic approaches) or can involve radiation therapy using conformal external beam radiation therapy (EBRt) in patients with long life-expectancy.

High intensity Focused Ultrasound (HiFU) is a relatively new technology which is able to destroy cancer tissue through coagulative necrosis; together with brachy-therapy and cryosurgical ablation of the prostate, HiFU is one of the most attractive options for the non-invasive treatment of localised prostate cancer.

by dr Luigi Mearini

– September/October 2010

Table I. Successful outcome of HIFU is higher with low risk patients than with high risk patients. The above table shows the successful outcome reported by different investigators as a function of D’Amico risk.

investigator Low risk intermediate risk High risk

Uchida [3] 92% 75% 64%

Blana [4] 90% 84%

Mearini [5] 86.1% 79.6% 56.4%

Table 2. Disease-free survival rates (DFSR) outcomes following HIFU as reported in various studies. Device S = Sonablate; device A = Ablatherm.

study device N° patients

Clinical stage

definition of response

dFsR Years

Mearini [5] s 163 t1c-t3a N0M0 AstRo 2005 78% 3 yrs

Chaussy [6] A 271 t1-t2 Nx/0M0 AstRo 1997 82% 3 yrs

Blana [7] A 140 t1-t2 Nx/0M0 AstRo 2005 59% 7 yrs

Uchida [3] s 181 t1c-t2b N0M0 AstRo 1997 78% 5 yrs

Misrai [8] A 119 t1-t2 N0M0 AstRo 2005 30% 5 yrs

Poissonnier [9] A 227 t1-t2 N0M0 PsA < 1 ng/ml 66% 5 yrs

7

induced by thermal injury and subsequent edema and swelling of the prostate, which may increase its volume by up to 30% of its ini-tial volume. A TURP procedure carried out prior to HIFU, and/or the use of a catheter or suprapu-bic tube is the simplest way to solve this immediate complica-tion. A long-term, relatively fre-quent, complication (occurring in approximately 3.6% to 22% of cases) is bladder outlet obstruc-tion caused by a stricture of the bladder neck and/or the prostatic urethra. This can usually be man-aged with dilation; few such cases require pre-operative trans-ure-thral resection (TUR).

During the period of sloughing, that is the passage of necrotic tissue in which debris is elimi-nated through voiding, patients sometimes report dysuria and present irritative and/or obstruc-tive symptoms. Symptomatic treatment with drugs is usually sufficient for this. One other important complication arising from necrotic tissue is the high risk of urinary infection, which can usually be managed by long-term antibiotics.

A major complication of HIFU is the creation of urethro-rectal fis-tulae, which usually occur in the first two months after the pro-cedure. This is generally caused by edema, urinary infection, an inappropriate monitoring of the rectal wall or the carrying out of a procedure in a pre-treated gland (re-HIFU, HIFU for radio-relapse). The incidence of fistula creation has been dramatically

decreased (now in the range 0.5% - 1.2% of cases) as increased experience is gained in the prac-tical use of the procedure and with the use of cooling systems and safety monitors.

Urinary incontinence, usu-ally urge incontinence, tends to decrease with time till the end of edema and the elimination of necrotic debris. The incidence of urinary incontinence ranges from 0.6 to 15.4% of cases; stress urinary incontinence is rare.

As regards the incidence of impo-tence, this usually occurs in 20 to 50% of cases although the litera-ture data on this are controver-sial. The preservation of the lat-eral edges of the prostate, the so called nerve-sparing HIFU, per-mits erectile function to be saved. The presence of colour Doppler in new software should help identify neurovascular bundles and so to retain sexual function.

Outcomes Several publications describing the use of the Ablatherm and Sonablate devices have con-firmed the efficacy and safety of HIFU. Appropriate patient selec-tion is vital: in general HIFU is recommended for patients with localised prostate cancer (clini-cal stage T1-T2 N0M0, Gleason score <=7, a baseline PSA value <=15-20 ng/mL, and a prostate volume < 40 mL). Best results are achieved for patients with low risk disease and interme-diate risk disease according to the D’Amico risk classification; high risk disease presents an

unacceptable risk of biochemical and/or local persistence/relapse [Table 1].

The end points used in these stud-ies are either biochemical (i.e. using varying definitions of PSA end-points to determine disease-free survival rates) and/or biopsy data. One method of determining failure of treatment is the use of the ASTRO criteria (i.e. three consecutive PSA increases after the PSA nadir has been reached), although the ASTRO-Phoenix definition of bio-chemical failure (i.e. PSA nadir plus 2 ng/mL) is more usually accepted. More recently, other authors have used the Stuttgart Criteria for treat-ment failure, namely PSA nadir plus 1.2 ng/mL at call [Table 2].

Control of the disease, as indi-cated by negative biopsy findings, usually measured six months after HIFU, was observed to lie between 66 and 93.4%, with a difference between low/interme-diate risk and high risk patients [Table 3].

If the control biopsy is posi-tive, HIFU should be repeated. The safety profile of the HIFU technique permits an unlimited number of sessions, and up to five sessions have been described. However, the safety of re-HIFU has been a subject of discussion with world HIFU users; in partic-ular, the rate of incontinence and erectile dysfunction seems to be increased by re-HIFU sessions.


Table 3. Outcomes, as measured by prostate biopsy, following HIFU.Device S = Sonoblate; Device A = Ablatherm

study device N° patients Clinical stage Neg biopsy, %

Mearini [5] s 163 t1c-t3a N0M0 66

Blana [7] A 146 t1-t2 N0M0 93.4

Chaussy [6] A 271 t1-t2 Nx/0M0 84.6

Misrai [8] A 119 t1-t2 N0M0 35

Uchida [3] s 115 t1-t2 N0M0 64


Hall 9

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Prognostic factors capable of indicating the risk of treatment failure would be useful for the clinician so that the patient could be informed about the likelihood of the need for salvage treatment. Most authors agree that level of the PSA nadir (i.e. the lowest post-operative PSA value, usually achieved within 3-4 months) shows a clear association with the risk of treatment failure. The PSA nadir was found to be strongly associated with pre-operative baseline PSA and prostate volume and can be used to predict the risk of residual disease, shown by six months post-operative prostate biopsy [Table 4]. Salvage HIFUHIFU should be proposed as salvage ther-apy after external beam radiation therapy (EBRT) or failure after brachytherapy, as between 20% to 50% of patients may experi-ence a PSA failure over time. Before a local salvage approach is undertaken, local recur-rence must be verified and documented by prostate biopsies. Respecting the appropri-ate indications for best results is particularly important in the context of HIFU after EBRT or brachytherapy, since the rate of complica-tions is significant, e.g. the incidence of the occurrence of fistula can reach 7% and that of incontinence can reach 50% [Table 5].

Future developmentsOne of the most promising new develop-ments in the field is the use of MRI-guided

HIFU, and a prototype of an endorectal probe coupled with focused ultrasound has been developed and presented. New imaging methods such as fat-saturated gadolinium-enhanced MRI can demonstrate accurately the extent of tissue damage induced by HIFU, and multi-sequence MR imaging of the prostate gland should help physicians to discriminate between local and systemic fail-ure after HIFU procedures, thus reducing the significance of false-negative data from post-operative prostate biopsies in patients with a rising PSA level.

The immediate future looks likely to involve the use of HIFU as a focal therapy when there is an accurate and reliable diagnosis of mono-focal prostate cancer. The technique enables the treatment to be limited to areas of prostate cancer only, thus saving as much as possible the ‘healthy’ gland, and minimis-ing the risk of incontinence and impotency as far as possible.

The major arguments against such focal ther-apy can be classified under the broad head-ing of ‘understaging’, the argument centred around the multifocality of prostate cancer. Currently there is an increasing proportion of cases of early-stage, organ-confined, low-volume prostate cancer and it would appear that 13%–33% of patients have true unifo-cal disease. Focal therapy seems particularly appropriate for such patients [15,16].

HIFU is already being used (unfortunately also outside of formal clinical trials) and the preliminary data are encouraging, although the variability in the criteria for eligibility of enrolling patients in trials, the parameters of treatment, the length of follow-up and the absence of patient-reported outcomes make these results hard to interpret.

ConclusionsHigh-intensity focused ultrasound is a rela-tively new procedure for treatment of prostate cancer and promises to become the method of choice for patients with localised prostate cancer. HIFU has, of course, both advantages and disadvantages which should always be considered in the decision-making process.

Patients receiving HIFU should be carefully selected; the technique should be reserved for patients with low-intermediate risk dis-ease. The ASTRO-Phoenix criteria, prostate biopsy and PSA nadir are the best surrogates to define post-procedure disease control.

The immediate future looks set to involve the use of HIFU as a focal therapy when mono-focal prostate cancer is accurately and reli-ably diagnosed. Organ-sparing focal therapy may fill the gap between an active surveil-lance strategy and whole-gland treatment thus providing a reasonable balance between cancer control and quality of life issues in the future.

References1. Madersbacher S, et al. Cancer Res 1995; 55: 3346.2. Gelet A, et al. Eur Urol 1996; 29: 174.3. Uchida Tet al. BJU Int 2006; 98: 537.4. Blana A et al. Urology 2008; 72:1239.5. Mearini et al. J Urol 2009; 181: 105.6. Chaussy C & Thuroff S. Expert Rev Med Devices

2010; 7; 209.7. Blana A et al. World J Urol 2006; 24: 585.8. Misrai V et al. World J Urol 2008; 26: 481.9. Poissonier L Eur Urol 2007; 51(2): 381.10. Blana A et al. Urology 2004; 63: 297.11. Ganzer R et al. Eur J Urol 2008; 53: 547.12. Gelet A et al. Urology 2004; 63: 625.13. Zacharakis E et al. BJU Int 20087; 102: 786. 14. Murat FJ et al. Eur J Urol 2009; 55: 640. 15. Muto S et al. Jpn J Clin Oncol 2008; 38: 192.16. Ahmed et al. Nat Clin Pract Oncol 2007; 4: 632.

The authorLuigi Mearini, MD, Urologist Urology DepartmentUniversity of Perugia, Italy&Ospedale Santa Maria della MisericordiaSant’Andrea delle Fratte06100 Perugia, Italye-mail: [email protected]

8 URoLoGY – September/October 2010

Table 4. PSA nadir (i.e. the lowest post-operative PSA value, usually achieved within 3-4 months) can be used to predict the risk of resdiual disease.

study device N° patients Clinical stage PsA nadir (ng/ml)

Mearini [5] s 163 t1c-t3a N0M0 0.40

Uchida [3] s 115 t1-t2 N0M0 0.20

Blana [10] A 146 t1-t2 N0M0 0.50

Ganzer [11] A 103 t1-t2 N0M0 0.20

Misrai [8] A 119 t1-t2 N0M0 1

Table 5. Results and complications when HIFU is used as a salvage procedure.

N° pts Local control rate

Mean follow up (months)

G3 inconti-nence

Fistula

Gelet [12] 71 80% 14.8 7% 6%

Zacharakis [13] 31 93% 7.4 7% 6.4%

Murat [14] 167 73% 18.1 11% 5%

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10 NEWs iN BRiEF

ASIR reduces radiation dose associated with coronary CTA

A low-dose coronary computed tomogra-phy angiography (CTA) technique, namely adap-tive statistical iterative reconstruction (ASIR), can reduce the radia-tion dose associated with coronary CTA by 27 per-cent, according to a study in the September issue of

the American Journal of Roentgenology. ASIR is a technique that allows radiologists to reduce the noise in an image and improve image quality while reducing the radiation dose. The large multicentre study included 574 patients undergoing coronary CTA at three imaging centres. Comparisons with regard to patient and scan characteristics, radiation dose, and diagnostic study quality were performed between consecutive groups, initially using the standard CTA method and filtered back projec-tion (FBP,) and subsequently using ASIRThere was a 44 percent reduction in the median radiation dose between the FBP and ASIR cohorts. After adjustment for scan settings, ASIR was associated with a 27 percent reduc-tion in radiation dose compared with FBP.ASIR permits reduction in tube current while imparting a statistically significant reduction in radiation dose due to the direct relationship between tube current and dose.www.ajronline.org

Drug-eluting stents confirmed safe and effective for long-term use

Researchers at the Rabin Medi-cal Centre in Israel have deter-mined that the use of drug-elut-ing stents (DES) improves the long-term clini-cal outcome for patients undergo-

ing percutaneous coronary intervention (PCI). Randomised clinical trials indicate that DES decreases in-stent restenosis and the frequency of repeat revascularisation procedures in patients undergoing PCI, yet questions remain about the long-term safety and/or effective-ness of DES in routine clinical practice among large unselected population cohorts. In the current study, the Israeli team examined the benefits and long-term risks of DES by evalu-ating the established pattern of DES versus bare-metal stent (BMS) use in routine clinical practice in Israel. The study population com-prised all consecutive cases of PCI with stent implantation over a 4-year period. The entire

cohort consisted of 6,583 patients, 2,633 (40%) patients with a DES and 3,950 (60%) patients with BMS. The minimal follow-up time was 6 months, and the maximal follow-up time was 5.2 years, with a mean follow-up time of 3 years. Results show that use of DES reduced the occurrence of myocardial infarction and the need for clinically-driven target vessel revas-cularization (TVR). Mortality was significantly lower in the DES group, showing a persistent benefit of DES over time.http://tinyurl.com/2v4ouxb

New nuclear breast imaging technolo-gies associated with higher cancer risks

The risks and benefits of screening mam-mography are under constant scrutiny. Meanwhile, newer breast imaging tech-nologies, such as BSGI and PEM have been approved by the U.S. Food and

Drug Administration (FDA) and introduced into clinical practice. Preliminary studies have shown both to be promising at detecting can-cer; however, both involve the injection of radioactive material into the patient. BSGI uses a high-resolution gamma camera that allows for imaging with mild compression of the breast along with an injection of a nuclear radi-otracer, which is absorbed at a higher rate by cancerous cells. In PEM, radioactive material is injected into the body to measure metabolic activity and determine the presence of disease. Other technologies, not yet approved by the FDA, include dedicated breast CT and digital breast tomosynthesis. Dr R. Edward Hendrick, clinical professor of radiology at the University of Colorado-Denver, School of Medicine in Aurora, Co, USA reviewed recent studies on radiation doses from radiolog-ical procedures and organ doses from nuclear medicine procedures, along with Biologic Effects of Ionizing Radiation (BEIR) VII age-dependent risk data, to estimate the lifetime risk of radia-tion-induced cancer incidence and death from breast imaging exams using ionizing radiation. Two-view digital mammography and screen-film mammography were found to have an aver-age lifetime risk of fatal breast cancer of 1.3 and 1.7 cases, respectively, per 100,000 women aged 40 years at exposure and less than one case per one million women aged 80 years at exposure. Annual screening mammography (digital or screen-film) performed in women from age 40 to age 80 is associated with a lifetime risk of fatal breast cancer of 20 to 25 cases in 100,000. Dedi-cated breast CT and digital tomosynthesis were both found to have an average lifetime risk of fatal breast cancer of 1.3 to 2.6 cases, respectively, per 100,000 women 40 years of age at exposure.

A single BSGI exam was estimated to involve a lifetime risk of fatal cancer 20 to 30 times that of digital mammography in women aged 40 years, while the lifetime risk of a single PEM was 23 times greater than that of digital mammography. In addition, while mammography only slightly increases a woman’s risk for breast cancer, BSGI and PEM may increase the risk of cancers in other organs as well, including the intestines, kidneys, bladder, gallbladder, uterus, ovaries and colon. Currently, no one is advocating using PEM or BSGI as a screening method to replace mammography. These exams are typically per-formed on women with suspicious breast lesions and in women with dense breasts who are dif-ficult to examine with other techniques. Despite the increased radiation dose, these exams have shown promise in detecting cancer accurately and may have a good risk-benefit ratio for some specific indications.http://radiology.rsna.org/

Molecular imaging identifies high-risk patients with heart disease

A study published in the August Journal of Nuclear Medicine (JNM) finds that molecular imaging can identify high-risk patients with potentially life-threatening cardiovascular con-ditions and help physicians determine which patients are best suited for implantable cardio-verter defibrillator (ICD) therapy. According to researchers from Sapporo University, Sapporo, Japan, molecular imaging can play an important role in diagnosing and guiding the treatment strategy for arrhythmia, coronary artery disease and heart failure. In their study, the researchers hypothesised that both the impairment of myo-cardial perfusion and/or cell viability and car-diac sympathetic innervations are responsible for heart arrhythmia and sudden cardiac death, but there was no established, reliable molecular imaging method. The researchers investigated prognostic implications of cardiac pre-synaptic sympathetic function quantified by cardiac MIBG activity, and myocyte damage or viabil-ity quantified by cardiac tetrofosmin activity, in patients treated with prophylactic use of ICD, by correlation with lethal arrhythmic events which would have been documented during a prospec-tive follow-up. The study is the first to show the efficacies of the method for more accurate identification of patients at greater risk of lethal arrhythmias and sudden cardiac death (SCD).http://jnm.snmjournals.org


Strict glycemic control (SGC) has been shown to decrease mortality and morbidity in inten-sive care unit (ICU) patients in two randomised controlled trials (RCTs) [1,2]. However five subsequent RCTs failed to show the benefit of SGC [3-7], with one trial even suggesting that SGC was harmful [6]. There are several expla-nations as to why these five negative RCTs of SGC showed no beneficial effects.

Randomised controlled trials of Strict Glycemic Control (SGC)The first single–centre RCT was carried out in Leuven, Belgium and showed that SGC signifi-cantly decreased mortality in a single–centre sur-gical ICU (4.6% in the intervention group versus 8.0% in the control group) [1]. In addition, SGC reduced the incidence of bloodstream infections, acute renal failure requiring dialysis or hemofil-tration, red–cell transfusions and critical illness polyneuropathy. SGC was also associated with a shorter period of ventilatory support. The second single–centre RCT from Leuven

showed that SGC reduced morbidity — but not mortality — in a medical ICU [2]. The power analysis for this RCT was based on the number of patients requiring ≥ 3 days in the ICU. This trial, however, only recruited 767 patients who stayed ≥ 3 days in the ICU, and not the 1200 patients as required by calculation of the power analy-sis. Consequently, the RCT was not powered to detect a difference in mortality in the intention to treat analysis. In fact, a per protocol analysis of patients who stayed in the ICU ≥ 3 days did show a difference in mortality (43.0% in the interven-tion group versus 52.5% in the control group).

Subsequent trials A single–centre RCT from Saudi Arabia revealed no significant difference in ICU mor-tality (13.5% in the intervention group versus 17.1% in the control group) [3]. In a single–centre RCT carried out in Colombia, the 28–day mortality rate was not affected by SGC (36.6% in the intervention group versus 32.4% in the control group) [4].

A multi–centre RCT of patients with severe sepsis from Germany was stopped prematurely on safety grounds, namely an increased inci-dence of severe hypoglycemia with SGC [5]. At 28 and 90 days, there was not a significant dif-ference in mortality (24.7% and 39.7% respec-tively in the intervention group versus 26.0% and 35.4% in the control group). In a RCT carried out in Australia/New Zealand and Canada, the 90–day mortality was unex-pectedly even higher with SGC (27.5% in the intervention group versus 24.9% in the control group) [6]. Finally, in a European multi–centre RCT, SGC was again not associated with a reduction in mortality (15.3% in the intervention group versus 17.2% in the control group) [7].

Differences between the randomised controlled trials of SGCApart from the basic possibility that SGC may indeed not benefit ICU patients, there are sev-eral possible explanations as to why the five negative RCTs did not show beneficial effects for SGC. Variability in the administration of SGCSGC may on the face of it appear easy to imple-ment, but there are several potentially impor-tant practical aspects of SGC that are frequently overlooked [8]. In the two positive RCTs from Leuven, SGC was applied using a reliable con-tinuous infusion of insulin exclusively via a cen-tral venous line, using accurate syringe–driven infusion pumps. Subtle insulin dose adaptations

strict or loose glycemic control in critically ill patients? Conflicting evidencethere is a substantial body of evidence showing the negative effect of hyperglycemia in critically ill patients, thus quantifying the adoption of strict glycemic control (sGC) measures in which insulin is administered to enable a pre-determined blood glucose level to be reached. two randomised controlled trials (RCts) showed that sCG did indeed reduce mortality and morbidity. since then, however, other RCts have failed to reproduce the conclusions of the original trials. this article discusses possible rea-sons for the discrepancies in the trial results and discusses the future outlook.

by dr Marcus J schultz

11iNtENsiVE CARE – September/October 2010

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were made only by ICU nurses, based on guide-lines aiming for blood glucose levels close to the lower normal limit, but also requiring a high level of intuitive decision–making. The blood glucose level in arterial blood was measured by the ICU nurses using accurate blood gas analysers at strict time points, and at intermediate time points between these predetermined points whenever this seemed necessary. Finally, patients were kept in a non–fasting state at all times.

Several of these methodological aspects of SGC were substantially different in the later RCTs. Indeed, instead of accurate syringe–driven infu-sion pumps, volumetric infusion pumps were sometimes, or always, used [3,4]. Alternatively, the type of pump used was not mentioned at all [7]. The level of knowledge of, and training in, the guidelines on the part of ICU nurses was not specified [5,7], or was restricted to training related more to the prevention and correction of hypoglycemia [3]. It was also not specified whether insulin was administered exclusively by ICU nurses [5]. Blood glucose measure-ments could have been made in capillary whole blood samples, using less accurate glucose ana-lysers [3-7]. Finally, glucose administration on the first day was often not specified and thus probably not a part of the protocol [3,5,7].

More problematic is the “expertise–based control system” applied by the ICU nurses from Leuven. This involved an algorithm that

contained only a set of simple rules. In particu-lar, there was an absence of explicit rules, such as are used in closed–loop systems, computer–based decision support systems, and paper–based systems using sliding scales. A high level of intuitive decision–making by the nurses was thus required. It is difficult, if not impossible, to identify and copy the specific elements of this “intuitive control system” that undoubtedly contributed to the outcome observed in the tri-als from Leuven. The same may apply for the skill and motivation of ICU nurses from Leu-ven. In this context it is important to note that the interventional arms of some of the multi–centre RCTs contained very low numbers of patients [5,7]. The question can be raised as to whether the staff involved in these trials were experienced enough and truly skilled in SGC.

Design of randomised controlled trials of SGCThe smaller RCTs were all statistically under-powered to detect a reasonable mortality differ-ence [3-5]. In particular, the early termination of the RCT from Germany was inopportune [5]: while this study performed best in the interven-tion group, with blood glucose levels closer to the upper limit of SGC than the other negative trials, the study protocol allowed for early ter-mination on safety grounds. The increase in the incidence of severe hypoglycemia forced the investigators to stop the study, leaving us with yet another underpowered RCT analysis.

Change in standard of care – hyperglycemia is not longer accepted A policy of insulin therapy to target lower blood glucose levels has been adopted in many ICUs since the publication of the first RCT of strict glycemic control [1]. Accordingly, in all trials except for two, glycemic control had improved in the control group compared to the original RCT. In addition, an increase was noticed in the number of patients who received insulin, or there was an increase in the amount of infused insulin in the control group [2-7]. This factor makes the subsequent RCTs fundamentally different from the original trial. Indeed, these RCTs were car-ried out in the “flattened” part of the observa-tional blood glucose level – mortality risk curve [9]. In the most recent two RCTs [6,7], the extent of the expected effect, namely an absolute reduc-tion of – 4% in the risk of death — that is, similar to that observed in the original RCTs [1,2] was therefore too optimistic [10].

Timing of the start of SGCWhen the time till target is too long, the time window for the prevention of toxicity cause by hyperglycemia may have passed and irrevers-ible damage may already have occurred [11]. This phenomenon has also been suggested by the pooled analysis of the two original RCTs [10]. In most trial descriptions the time taken to reach the preset blood glucose level target is insufficiently reported. In one trial, this appeared indeed to be an important factor,

12 iNtENsiVE CARE – September/October 2010

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since initiation of SGC in that trial was delayed by more than 13 hours because of randomisation [6].

The blood glucose levels achieved with SGCNone of the RCTs carried out after the two original trials managed to achieve the strict degree of glycemic control achieved by the Leuven investigators [1,2]. Indeed, no trial had a median or mean blood glu-cose level in the intervention group below the upper normal target of blood glucose. It is interesting to note that one meta–analysis suggests that studies which managed to achieve the blood glucose target showed a reduced mortality whereas studies that did not succeed in reaching the target reported no benefit or even an increased mortality [12].

Discussion and future perspectivesLowering blood glucose levels has the potential to prevent injury to already threatened vital organs. However, the precise optimum blood glucose level target is still to be defined as is the optimal methodology as to how to reach that level. The observations that SGC showed both positive [1,2] and negative effects [6] thus presents a fascinating impasse. The currently available evidence from all seven RCTs does not allow a confident, overall recommendation to be drawn. In the absence of a defined optimal target level of glycemic control, any advice on the interpretation of RCTs on SGC remains pragmatic: it should be verified that the extent of expected benefit was realistic, whether the statistical power was sufficient and whether the level of evi-dence of the studies was appropriate. Likewise, it should be verified that the methods and equipment used to measure and control blood glucose were adequate, it should be checked whether the targets were achieved, and finally it should be checked whether the levels of glycemic control were significantly different. Clinicians should also determine how com-parable the patients in the different RCTs are to their own and decide on what is their best target for glycemic control.

Alternatively, we could perform yet another trial, using the same targets as in the RCTs from Leuven [1,2], both for the interventional and the control group. This, however, may be unethical, if not impossible, for two reasons. The standard of care regarding glycemic control has defi-nitely changed over the last decade. How could we justify carrying out a new trial in which critically ill patients would be deliberately exposed to the risks of hyperglycemia? Secondly, one could also argue that it is unethical to discard the evidence from the two positive RCTs, and we are obliged to repeat this study.

Given the substantial evidence of the generation of harm from hyperg-lycemia [9,13-15] and the conflicting results from the seven published RCTs [1-7], considerable work remains to be done in identifying the con-founding factors in the clinical application of SGC. This process needs to be explicit and systematic, and should at least include the points as brought up here. If new RCTs of SGC are to be performed, investigators should recognise the several shortcomings of the recent negative trials, as described. An individual patient data meta–analysis examining the discrepancies between studies may be a good alternative.

References1. Van den Berghe G et al. N Engl J Med 2001; 345: 1359.2. Van den Berghe G et al. N Engl J Med 2006; 354: 449.3. Arabi YM et al. Crit Care Med 2008; 36: 3190.4. De La Rosa GDC et al. Crit Care 2008; 12: R120.5. Brunkhorst FM et al. N Engl J Med 2008; 358: 125-139.6. Finfer S et al. N Engl J Med 2009; 360: 1283-1297.7. Preiser JC et al. Intensive Care Med 2009; 35(10):1738-48.8. Van den Berghe G et al. J Clin Endocrinol Metab 2009; 94: 3163-3170.9. Bagshaw SM et al. Crit Care Med 2009; 37: 463-470.

10. Van den Berghe G et al. Diabetes 2006; 55: 3151-3159.11. Ceriello A et al. J Clin Endocrinol Metab 2009; 94: 410-415.12. Griesdale DE et al. CMAJ 2009; 180: 821.13. Finney SJ et al. JAMA 2003; 290: 2041-2047.14. Krinsley JS. Mayo Clin Proc 2003; 78: 1471-1478.15. Falciglia M et al. Crit Care Med 2009:

The authorMarcus J Schultz, internist–intensivist, MD PhD FCCP 1,2

Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands1Department of Intensive Care2Laboratory of Experimental Intensive Care and Anesthesiology

Correspondence:Marcus J. Schultz, Dept of Intensive Care Medicine C3–415Academic Medical Center, University of AmsterdamMeibergdreef 91105 AZ Amsterdam, The NetherlandsTel: +31–20–5669111; Fax: +31–20–5669568E–mail: [email protected]


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In this period of straitened eco-nomic circumstances, nurse staffing levels in critical care units (CCU) are a contentious issue. This article will highlight the main points of recently pub-lished guidelines for nurse staff-ing levels in the UK with a view to sharing the UK experiences with the wider intensive care community. Traditionally nurse staffing levels in the UK were set in 1967 at one nurse for one ven-tilated patient [1]. Staffing costs represent 50-60% of the total budget for critical care in the UK and nurse staffing represents a sizable proportion of this [2]. It is therefore not surprising that nurses have been challenged to defend these staffing levels.

In the year 2000 the UK Depart-ment of Health recommended that the existing division into high dependency (HDU) and intensive care (ICU) beds be replaced by a classification based on the level of care required by the patient, and therefore in this article the term “critical care” will be used as an overarching term for HDU and ICU [2]. The British Association of Critical Care Nurses (BACCN) has an exemplary history for publishing position statements (guidelines) in order to provide evidence-based information for nurses.

Developing safe standards for nurse staffing levels in ICUsThe safety of the critically ill, ven-tilated patient is paramount hence the traditional nurse to patient ratio of 1:1. In recent years nurses have come under mounting pressure to review this ratio. Nurses in the UK turned to their professional organi-sations for guidance on this matter. As there are several organisations in the UK with an interest in critical care nursing, it was deemed appro-priate that these should collaborate to review previously published guidelines and review the evidence base for staffing levels in critical care. The organisations involved included the British Association of Critical Care Nurses (BACCN), the Royal College of Nursing Critical Care and In Flight Forum (RCN) and the Critical Care Networks National Nurse Leads (CC3N) [see side-bar at the end of the article].

Previously published guidance on staffing levels have included that issued by BACCN in 2001 [3] and revised in 2005 [4] as well as that issued by the RCN in 2003 [5]. In 1999 the Audit Commission [6] found that there was significant variation in the number of nurses employed in critical care units. In addition to this, although the ratio of nurse to patients for high depend-ency or Level 2 patients [2] was 1:2, a

stable ventilated patient may require far less nursing input than an agi-tated high dependency patient. This prompted the challenge on tradi-tional staffing levels in critical care.

The BACCN started to receive enquiries from its members who were under pressure from their employers to work more flexibly. Whilst the nurses were not averse to this, they were concerned about patient safety and that the set ratios would be lost completely once a prec-edent had been set for working with fewer staff. Therefore the BACCN, RCN and CC3N worked collabora-tively and published the Standards for Nurse staffing in Critical Care in 2010 [7]. Representation was sought from the members of the three organisations: a standards committee was formed with the remit to review a wide range of evidence and make

recommendations for nurse staffing levels in critical care.

The standards committee met on a number of occasions to agree terms of reference and develop a structure for the staffing standards docu-ment, but the main work involved the review of evidence. A number of bibliographic databases were searched, which resulted in approxi-mately 3000 pieces of evidence being reviewed. The evidence included in the standards supports the higher ratio of nurses to deliver safe and effective critical care, and has been grouped into the following themes:

• Infection control• The individual experience and

competence of each nurse• Size, geographical layout and

number of beds in a unit• The need for larger units to have a

standards for the level of nurse staffing in critical care unitsthe gold standard for nurse staffing levels in critical care in the United Kingdom has been established since 1967 at one nurse for each patient. Recent evidence suggests how-ever that there is a great deal of difference in the staffing levels and skill mix between individual critical care units in the UK, with the result that nurses are being challenged to justify and defend the 1:1 ratio. the aim of this article is to provide the wider intensive care community with an over-view of the standards for Nurse staffing in Critical Care units as proposed by the organisations representing critical care nurses in the UK.

by Vanessa Gibson

14 iNtENsiVE CARE – September/October 2010

The standards recommended by the three UK professional CCU nursing levels to allow flexible working yet maintain patient safety.

standards for Nurse staffing in Critical Care Units determined By:the British Association of Critical Care Nurses

the Critical Care Networks National Nurse LeadsRoyal College of Nursing Critical Care & in-flight Forum

1. Every patient in a Critical Care Unit must have immediate access to a registered nurse with a post registration qualification in this specific speciality

2. Ventilated patients should have a minimum of one nurse to one patient

3. The nurse patient ratio within any Critical Care Unit should not go below 1 nurse to 2 patients

4. The level of care needs required by each patient should equate to the skills and knowledge of the registered nurse delivering and/or supervising that care

5. Critical Care Units should employ flexible working patterns as determined by unit size, activity, case mix and the fluctuating levels of care for each patient, to ensure patient safety and care delivery

6. A supernumerary clinical co-ordinator, who is a senior critical care qualified nurse will be required for larger and geographically diverse units of more than 6 beds. The clinical co-ordinator’s role is to ensure effective, safe and appropriate care is delivered each shift, by managing and supporting staff and patients, and acting as a communicator and liaison between the rest of the multi-discipli-nary team.

7. The layout of beds and use of side wards in a Critical Care Unit must be taken into account when setting staffing levels to ensure safe patient care.

8. On-going education for all nursing staff working in critical care is of principal importance to ensure knowledgeable and competent staff care for patients. Clinical Educator posts should be utilised to support this practice.

9. Health Care Assistants (HCAs) have a key role in assisting registered nurses in delivering direct patient care and in maintaining patient safety. These roles should be developed to meet the demands of patients and of the unit. However, the registered nurse remains responsible for the assessment, planning, delivery and evaluation of patient care.

10. The Assistant Practitioner’s (APs) role in Critical Care can provide direct patient care under the indirect supervision of a registered nurse, who will remain responsible for the assessment, planning and evaluation of patient care. The effectiveness of the role of Assistant Practitioners in Critical Care Units requires further evaluation and research.

11. Administrative staff should be employed to ensure registered nurses are free to give direct patient care, and to support the critical care units and staff with essential data collection.

12. Critical Care nurses should be proactive in the development of multi-professional team working to optimise quality patient care and ensure a quality service.

supernumerary shift co-ordinator • Case mix and patient dependency• Safety in relation to ventilated

patients• Mixed sex accommodation needs• Team working • Use of evidence based protocols• Ongoing education and develop-

ment of critical care nursing • Administrative support for

mandatory data collection

The staffing standards document acknowledged that nurses’ roles in critical care in the UK may be distinct from other countries and therefore these staffing levels may not be applicable in other coun-tries. National critical care organi-sations in other countries are therefore encouraged to conduct

their own reviews and develop their own standards.

After the lengthy review process the final document was launched at the BACCN National Conference in September 2009 and can be found on the website at www.baccn.org.uk. In order to reach a wider audience, a shortened version was published in the BACCN’s professional journal, Nursing in Critical Care May/June edition 2010 [8].

ConclusionThe review of the evidence related to staffing levels in critical care has demonstrated that the contribu-tion of nursing can be difficult to measure. Despite this there is an emerging body of evidence which

supports a high nurse-to-patient ratio in critical care. The safety of patients is paramount, and nurses need to protect patients and their current working conditions with firm evidence. In order to do this nurses need to be pro-active in the necessary data collection processes which are now part of the modern-day critical care unit. Nurses need to develop valid and reliable meas-urement tools to collect data on the contribution of nursing to patient outcomes in critical care. Only by developing and participating in data collection and evidence review will nurses be able to develop and defend appropriate staffing levels. Intensive care organisations and societies should think more broadly than just about nurse staffing levels, and work collaboratively to pro-vide joint staffing standards across all professional groups for safe and effective critical care services.

AcknowledgementWith thanks to the British Association of Critical Care Nurses, Royal College of Nursing Critical Care and In-Flight Forum, the Critical Care Networks National Nurse Leads and original authors Bray K, Wren I, Baldwin A, St Ledger U, Goodman S, and Walsh D.

References 1. British Medical Association. Intensive

Care planning Unit Report No. 1. Brit-ish Medical Association, London 1967.

2. Department of Health. Comprehensive

Critical Care: A Review of Adult Critical Care Services. Department of Health, London, 2000.

3. British Association of Critical Care Nursing. Position Statement. Nurse-patient ratios in critical care. Nursing in Critical Care 2001; 6(2): 59-63.

4. British Association of Critical Care Nurses. Position Statement On Nurse-Patient Ratios in Critical Care (Revi-sion) 2005. www.baccn.org.uk

5. Royal College of Nursing. Guidance for Nurse Staffing in Critical Care. Royal College of Nursing, London, 2003.

6. Audit Commission. Critical to success: the place of efficient and effective criti-cal care services within the acute hos-pital. The Audit Commission, London, 1999.

7. Standards for Nurse staffing in Critical Care www.baccn.org.uk

8. Bray K, Wren I, Baldwin A, St Ledger U, Gibson V, Goodman S, and Walsh D. Standards for nurse staffing in criti-cal care units determined by: The Brit-ish Association of Critical care Nurses, The Critical Care Networks National Nurse Leads, Royal College of Nurs-ing Critical Care and In-flight Forum. Nursing in Critical Care 2010; 15(3): 109-111.

The author Vanessa GibsonProfessional Advisor BACCNTeaching Fellow, Critical Care NursingNorthumbria University Newcastle, UKe-mail : [email protected]

15 – September/October 2010

The British Association of Critical Care Nurses (BACCN)The BACCN was set up 25 years ago and is dedicated to the promotion of excellence in the provision and delivery of critical care nursing through mutual support, education research and multi-disciplinary collaboration. The BACCN has over 3000 members and 15 regions that cover the UK. The BACCN pro-vides guidance for nurses but a vital role of the BACCN is in ensuring that critical care nursing is represented in many national arenas, such as at the Department of Health and National Insti-tute of Health and Clinical Excellence (NICE). This ensures that critical care nurses help shape national policy and contribute to the develop-ment of national guidelines. The BACCN is managed by an elected national board and each region has a regional committee. The BACCN

holds an annual national conference and each of the regions hold regular study events. The BACCN is a member of the European Federa-tion of Critical Care Nursing Association and the World Federation of Critical Care Nurses.

The Royal College of Nursing Criti-cal Care and In-Flight Forum (RCN)The RCN is a very large, general nursing organisation which provides a wide range of services for nurses. It represents nurses and nursing, promotes excellence in practice and shapes health policy. As the RCN is a general nursing organisation, the RCN forums were set up to bring together members working in similar nursing specialities or with similar interests. There are 41 RCN forums with the Critical Care and In-Flight Forum dedicated to representing critical care nurses.

Critical Care Networks National Nurse Leads (CC3N)In its seminal publication “Comprehensive Critical Care: A review of adult critical care services”, the Department of Health suggested in 2000 that hospital trusts form networks with the objective being that healthcare providers and commissioners work together to meet the needs of all critically ill patients in their geographical area. Therefore Critical Care Networks were set up to represent regions across the UK to assess the needs of critically ill patients, plan services and agree common standards and protocols. Each critical care network has a lead nurse. The CC3N is a professional advisory group, as well as a group which shares best practice and bench marks across regions to ensure consistency and standards of care. This group advises on nursing elements of critical care at all levels.

The three UK nursing organisations which collaborated on the new standards are BACCN, RCN and CC3N

Nurse staffing costs are a large part of total ICU budgets, so staffing levels are being challenged. Nurses should participate in ICU data collection and evidence reviews to

defend appropriate staffing levels, with the goal of maintaining patient safety.

Glucose metabolic imaging of can-cer using PET/CT with 18F-fluoro-deoxyglucose (18 FDG) is based on the fundamental, well documented fact that, metabolically, malignant tumours consume large amounts of glucose even in the presence of oxygen; this is the process known as aerobic glycolysis that was first dis-covered (in vitro) by Otto Warburg in the 1920s. Other historical high points in the development of the FDG-based PET/CT technique was the fluorination in the 1960s of the glucose analogue 2-deoxyglucose and the development by Michael E. Phelps of the first PET scanner in the 1970s. Advances in computational capabilities in the late 1980s allowed for the acquisition of whole body PET data. The final breakthrough occurred with the development of combined PET/CT imaging systems in the late 1990s; such systems are capable of acquiring anatomic and molecular/functional information near simultaneously.

Current PET/CT systems combine high-end CT with high-end PET systems. It is therefore now possi-ble to conduct whole body surveys of glucose metabolism and acquire fully diagnostic CT studies at the same time. More than 3000 PET/CT systems have been installed world-wide and more than 2.5 million can-cer patients have been studied glo-bally using FDG-PET/CT. Although this number is in itself impressive, it should be noted that it is actually

relatively low when compared to the 25 million straightforward CT scans performed for tumour imag-ing in the United States alone (with proportionally similar numbers in other developed countries). Recent changes in PET/CT reimbursement in the United States look set how-ever to result in a higher utilisation of the technique to the benefit of cancer patients.

The glycolytic phenotype of cancer 18F-FDG PET imaging of cancer is based on the high glucose consump-tion of malignant tissue. In other words, cancer cells switch to a glyco-lytic phenotype in order to provide energy for rapidly growing tissue, and, equally important, to provide the carbon backbone for DNA and RNA synthesis.

After transport of 18F-FDG into tumour cells via the glucose trans-porters 1 and 3 (GLUT 1 & 3 respectively), 18F-FDG is phosphor-ylated by the enzyme hexokinase to 18F-FDG-6-phosphate which cannot be further metabolised and is there-fore essentially trapped in tumour cells. 18F-FDG tumour uptake thus depends upon GLUT expression and activity as well as hexokinase expression/activity which them-selves depend on various signal transduction pathways.

The information that can be derived from 18F-FDG-PET imaging is

both diagnostic and prognostic. PET imaging is therefore used for diagnosing, staging or restaging of cancer as well as for monitoring the effects of therapeutic interventions. In addition, the degree of tumour 18F-FDG uptake carries important prognostic information.

However, the metabolic switch to a glycolytic phenotype is not can-cer specific. For instance, activated lymphocytes, which divide just as rapidly as cancer cells, also consume large amounts of glucose, as do mac-rophages. Therefore, false positive findings are not uncommon and occur most frequently in granuloma disease, acute infections, benign tumours and inflammation.

The addition of CT imaging to PET has mostly improved the specificity of PET. However, some tumours exhibit a low glycolytic phenotype. While PET cannot be used for diagnostic purposes in such can-cers their low glycolytic phenotype

can provide important prognostic information. Such tumours can be readily identified with CT and their growth behaviour can be monitored using CT.

18F-FDG - PET/CT imaging is now most often used for staging, restag-ing and monitoring of head and neck cancer, solitary lung nodules and lung cancer, breast cancer, colorectal cancer, lymphoma and unknown primary tumours. Imaging protocols Unfortunately, PET/CT imaging protocols frequently vary from institution to institution, which highlights the need for standardi-sation. In the most frequently used protocol, patients fast for 4–6 h prior to the injection of FDG. Again, the injected dose is variable. At our insti-tution in UCLA a dose of 0.20mCi/kg (7.4mBq/kg) is administered. Imaging commences one hour after the tracer injection. We have adopted a “one-stop shop” protocol and give

Assessing the glucose metabolic phenotype of cancer using FdG-PEt/Ctimaging procedures using 18F - FdG PEt/Ct has improved the diagnostic performance of the individual techniques of PEt and Ct and, with its ability to simultaneously acquire both ana-tomic and molecular/functional information, FdG PEt/Ct is emerging as the most important diagnostic tool in oncology. this article briefly reviews the technique and its applications. With progress being made on the standardisation of proto-cols, as well as the development of new probes, the use of PEt/Ct is being expanded to all major cancers.

by dr J Czernin

16 MEdiCAL iMAGiNG – September/October 2010

Figure 1. 71 year old male with a history of colorectal cancer. PET MIP (A) and selected fused axial images demonstrate metastatic disease to the lungs (A, white arrow), mediastinal lymph nodes (B, white arrows), liver (C, white arrow) and right

adrenal gland (C, white arrow head).

both oral and intravenous contrast whenever clinically justified. PET/CT images are acquired during shallow breathing. The whole body contrast CT is used as diagnostic CT scan and is also used for attenu-ation correction. For PET imaging we use a weight-based protocol that can be as short as one minute/bed position in very thin patients or as long as five minutes/bed position in obese patients.

Clinical applications:A large body of evidence supports the notion that 18F-FDG PET/CT imaging is more accurate than PET or CT imaging alone for diagnosing, staging or restaging of cancer. Studies conducted in patients with sarcoma, head and neck cancer, lung cancer, colorectal cancer, lymphoma, breast cancer and others that support this notion were recently reviewed in detail [1]. Most confirm that the combination of the glucose meta-bolic and the anatomic phenotypes provides powerful diagnostic and prognostic information.

An imaging modality that does not impact patient management is, fundamentally, meaningless. To determine the impact of PET/CT imaging on patient management, the National Oncology PET registry (NOPR) has been established in the US and more than 120,000 patients have been enrolled in the registry. Published studies are summarised in reference 1. They confirm that 18F-FDG -PET/CT imaging infor-mation affects management deci-sions in more than 30% of all cancer patients and that this impact was near identical for staging, restaging or monitoring the effects of thera-peutic interventions across all can-cers. Based on these data, coverage for PET/CT by the US Center of Medicare and Medicaid (CMS) has recently been expanded to include all major cancers. PET/CT can now be used for initial and subsequent treatment strategy assessments in breast, cervix, colorectal, oesopha-gus, head/neck and lung cancer, as well as lymphoma, melanoma, mye-loma, ovarian cancer and others.

Many other imaging probes are emerging that will allow more com-prehensive non-invasive cancer phenotyping. These include probes

of tumour proliferation (18F-Fluor-othymidine), amino acid metabo-lism (18F-FDOPA and others), lipid metabolism (18F-choline, 11C-ace-tate) as well as markers of tumour hypoxia, apoptosis and others. These will be important for char-acterising tumours before and after treatment and may lead to more rational treatment and treatment monitoring approaches.

Conclusion 18F-FDG PET/CT imaging has improved the diagnostic

performance of PET and CT alone. Attempts to standardise imaging protocols are underway and PET-based response criteria have been proposed in Europe and the United States. FDG-PET/CT imaging has emerged as the most important diagnostic tool in oncology.

References1. PET/CT imaging: The incremental

value of assessing the glucose meta-bolic phenotype and the structure of cancers in a single examina-tion. Czernin J, Benz MR, Allen-

Auerbach M. European Journal of Radiology 2010; 73: 470–480

The authorJohannes Czernin, MDAhmanson Biological Imaging Division, Nuclear MedicineDepartment of Molecular and Medical PharmacologyDavid Geffen School of Medicine at UCLA10833 Le Conte AvenueLos Angeles, CA 90095-6948, USAe-mail: [email protected]


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18 it CAsE stUdY

Q: Exactly what (and where) is the East Groningen Hospital Collaboration Foundation? How big are the institutions involved in the collaboration?

Known by its Dutch language acronym of SSZOG (Stichting Samenwerking Ziekenhui-zen Oost Groningen), the foundation involves a collaboration between two separate hospital groups, which jointly have three different phys-ical locations, so that they can cooperate and work together for their mutual benefits. The first hospital group, Ommelander Ziekenhuis Groep (OZG), has two sites, one at in Delfzijl, which is about 25 km north-Eeast of the city of Groningen (itself in the far north of The Neth-erlands, relatively near to the German border), and the other in Winschoten, which is approxi-mately 45 km due east of the city of Groningen. Together, these two facilities of the OZG hos-pital have about 420 beds. The other hospital in the collaborative group is Refaja Hospital, which is located in the town of Stadskanaal, approximately 55 km south east of Groningen. The Refaja hospital has 200 beds.

Q: What services do the hospitals offer, and what radiology facilities do they have?

All three facilities of the hospitals provide a full range of modern healthcare services. The radiology departments in the three hospitals each have an MRI scanner and a CT scanner. All departments work with DR systems, and DR mammography is also carried out by each of the three hospitals. Ultrasound and angi-ography examinations are also performed in all three hospitals. In short, each individual location can deliver a full range of radiology

services to patients. All three hospitals had their own individual RIS/PACS system.

Q: With all these imaging systems, how many radiology studies does that add up to in total for the three hospitals? What about these individual PACS systems that each hospital uses?

In the OZG (the hospital with the two sepa-rate sites), there are a total of 85.000 radiology exams carried out per year. As for the Rejafa hospital, they do 45000 exams per year. Regarding PACS/RIS, the original system at

each site was, for historicaal reasons supplied by a different vendor. Thus, Refaja currently uses an AGFA RIS/PACS system whereas the Lucas site of the OZG hospital works with an AGFA RIS and a FUJI PACS system. As for the Delfzicht site of the OZG, they use an AGFA RIS and a Siemens PACS.

Q: What was the basic rationale behind the decision to implement the new RIS/PACS systems and how will it work?

One of the main driving forces behind our desire to instal the new system was the clear

Ris/PACs developments in the north of the NetherlandsRecently a consortium of independent hospitals in the north east of the Nether-lands, each with their own individual Ris/PACs systems, decided to get together and implement a new single Ris/PACs system that would enable total interchange of data yet still be compatible with the individual way of working of each hospi-tal. the system that the East Groningen Hospital Collaboration Foundation (the organisation grouping the three hospitals) decided to implement was the eHealth PACs system from Carestream. in addition to the image management services this also provides for a remote back-up and disaster recovery system, operated for the hospitals by the company.

international Hospital (iHE) wanted to know how this ambitious project was coming along, so we spoke to Mark van den Heuvel, the project manager responsible for the implementation of the new PACs system.


Apart from the advantage of having one single RIS/PACS supplier (Carestream), who are also reponsible for the provision of secure remote image archiving and access as well as disaster recovery, the new system pro-

vides many advantages for radiologists. For example, the simple fact of being able to interrupt the dictation of one patient report whenever there is a more urgent case, can result in a big saving of time overall.

Mark van den Heuvel is responsible for the installa-tion and operation of the RIS/PACS system.

19

advantage of being able to work with one sin-gle supplier of both RIS and PACS systems. We chose Carestream Health for this. We estimate that the new RIS and PACS systems are capable of providing several functions which, in the future, will actually reduce hos-pital time and costs.As to how the new system works, the founda-tion representing the three hospitals bought the RIS servers and system, and decided to go for a PACS based on an Application Service Provider (ASP) model. This basically means that the PACS and the associated data storage system are paid for by the using hospitals as a function of how much we use them. For us, large investments in storage capacity and the personnel necessary to maintain an adequate level of service would be hard to sustain in the future, particularly since CT and MRI imag-ing modalities create huge amounts of data, which look certain to continue to increase in the future. The ASP model should therefore save us significant costs in the long term. Under the new system, the Fryslan data cen-tre in Leeuwarden, to the west of Groningen, will provide secure remote image archiving and access together with disaster recovery. Fryslan is one of eight separate data centres operated by Carestream in five countries throughout Europe and North America. The new system is thus a big step forward, not only from the financial point of view of the hospitals, but it is in many respects also advantageous for the radiologists. For exam-ple, the simple fact of being able to interrupt the dictation of one patient report whenever there is a more urgent case, can result in a big saving of time overall. Likewise, if the radi-ologist has a question about another patient, he can open that study and dictate a report about the new patient, and then return to the first report without any additional work being required. In the end this, of course, also results in benefits for the patients. For example in the dictation case above, this means that at the moment of dictating, the temporary report will be immediately available, and using Edi-fact (Electronic Data Interchange system For Administration, Commerce and Transport), the final report can be with the referring physician the same day.

Q: How difficult was the practical implementation of the new system, especially in light of the fact that different PACS systems were previously used at each of the hospitals?

Of course the conversion from three different RIS and PACS to one system was a big chal-lenge. The fact that our hospitals were in differ-ent physical locations was in itself not a major issue since Carestream has a vast experience

of implementing systems in such cases. The real challenge came from the fact that in our consortium we had two different hospitals each with their own systems and sets of inter-nal procedures and regulations. For example, this meant that images taken in one hospital and stored on one PACS would only be made available in a second hospital if the patient had previously agreed to such an exchange of medical information. To make things even more complex, the nuclear medicine depart-ment, which works for the foundation/consor-tium as a whole, is an exception to this restric-tion. Because the department works for the whole foundation, the clinicians must be able to see all the X-rays from all three locations.

Because of the particular aspects of our set-up we significantly customised the basic RIS 11 system from Carestream. In the modifications that we introduced, we can not only book in the patient but also include all the additional information required. Thus data such as scan, patient information and referring physician are included on one form, so it isn’t necessary to use a tab page.One other customisation we introduced was a feature to cater for the fact that, in most hos-pitals here in the Netherlands, patients don’t need to make an appointment. To handle this, we created a “walk-in” patient option which means that we can book in the patient with-out having to access time and room choices. All that is needed in the “walk-in” system is to enter the patient number, the doctor and the requested exam and the scheduling for the appropriate modality pops up directly, i.e. with no need to search for a first scheduled time and then add a “patient arrived” message.Of course all this required some work from us. This was however facilitated by the hospi-tal agreeing to my request for a work-room to accommodate the four technicians who were

involved on a daily basis to customise the sys-tem. This was a near-perfect dedicated room of about 40 square meters containing six work stations, with each desk having two PCs: one to open the old RIS/PACS system and one to open the new one. In addition I requested five spare internet connections for the Carestream people so that every one could work at the same time. I have several recommendations for any hospi-tal IT personnel involved in the sort of imple-mentation/customisation process in which we were involved. One simple, but practical, rec-ommendation is never to forget to make sure that there is a printer installed in the work room. It’s amazing how much time can be saved if you don’t have to walk down a hallway to get to the first available printer. Likewise, another time-saving tip was having access to six inter-nal mobile telephones so that we could call our colleagues and key users directly without putting the whole X-ray department on hold. Of course it is always possible to use ordinary mobile phones but calls on these can cost a lot of money. Another advantage is that the inter-nal mobile phones will retain their usefulness when the system is in routine operation. In addition, from the personal point of view of the IT staff, it can be inconvient to give access to external mobile phones to clinicians since when the system is in routine operation there is always the danger that the clinicians will call up even for the smallest question including at the weekend. The internal mobile phones can also be used by the clinicians as a number for when we go live.

Q: Were there any qualms about giving management of data between and within the individual hospital sites to a private company?

This wasn’t an issue — Carestream is a profes-sional organisation and it has a lot of experience in treating patient information in an appropri-ate and confidential manner.

Q: How about accommodating future changes e.g handling future growth ?

It was for this very reason that we plumped for the ASP model since by giving responsibility for the management and storage of the data, any requirements that future growth places on the system becomes Carestream’s problem. Even if we grow 10 or even 20 % each year, for us it doesn’t matter: Carestream will make it work as stipulated in the contract that binds us. Even if other hospitals want to join in our existing collaboration, that in principle shouldn’t be a problem particularly since, with one exception, most of the hospitals in the region are already working with Carestream. We look forward to the moment when the whole system goes live.


OmmelanderZiekenhuis Groep (above) is one of the two hospitals in the consortium. The particular nature of the consortium — two separate hospitals spread over three physical locations, with each site having its own RIS/PAC system — meant that customisa-

tion of the basic system supplied by Carestream was required. The “proof of the pudding” of the new

system will only be assessed when the new system goes fully on stream.

20 WoMEN’s HEALtH

Breast cancer is the most common female cancer in the United States, the second most common cause of cancer death in women, and the main cause of death in women ages 45 to 55. In 2009, approximately 192,370 Ameri-can women were diagnosed with breast can-cer, and 40,170 women are predicted to die from the disease [1]. Triple negative breast cancer (TNBC) accounts for approximately 15 percent of breast cancers [2]. Although recently in the limelight and frequently dis-cussed, triple negative breast cancer is not a new type breast cancer. In fact, the term has recently been coined to describe a subtype of breast cancer that is defined by the lack of protein expression of estrogen receptor (ER), progesterone receptor (PR) and absence of HER2 protein over-expression. TNBC is an important area for both researchers and cli-nicians alike because of the following four important facts:

1. TNBC is a poor prognostic factor for disease-free survival and overall survival

2. As of today, there is no effective specific tar-geted therapy readily available for TNBC

3. There is clustering of TNBC cases in pre-menopausal women and in women of Afri-can descent

4. There is a significant overlap of BRCA-1 associated breast cancers with the TNBC phenotype

EpidemiologyIt has been estimated that 1 million cases of breast cancer are diagnosed annually world-wide [3]. Of these, approximately over 170,000 are of the triple-negative (estrogen receptor/progesterone receptor/HER2-negative) pheno-type [3]. Of these TNBC cases, approximately 75 percent are basal-like [4]. The prevalence of TNBC is highest in premenopausal African American women. It has recently been reported that 39 percent of all African American pre-menopausal women diagnosed with breast cancer are diagnosed with TNBC [5]. The prevalence of TNBC in this same age group in

non African American females is much less, at approximately 15 percent. Such ethnic or men-opausal differences are not seen in the ER+/HER2 positive breast cancer subgroup nor is it seen in the ER+/HER2 negative subgroups [5].

Many other studies have confirmed that TNBCs are found in a higher percentage of African American women. Of these triple negative breast cancers, about 75% of them are also of the basal type molecular classifica-tion. As presented initially in the San Antonio Breast Symposium in 2006, in a study of racial differences in the prevalence of triple negative invasive breast tumours, a team of research-ers from Emory University’s Rollins School of Public Health and Winship Cancer Institute, the Fred Hutchinson Cancer Research Center in Seattle, and the Centers for Disease Con-trol, found the incidence of triple negative dis-ease in African-American women to be more than twice that of white women. They found that 47 percent of tumours in black women were “triple negative” compared to 22 percent in white women. After adjusting for age and stage at diagnosis, black women were found to be almost 3-fold more likely than white women to have triple negative tumours [2].

These stark differences in the incidence of the disease in different racial groups leads us to question whether there are genes or muta-tions that predispose women in general and pre-menopausal African American women in particular, to TNBC. Studies have shown that breast cancers in women with germ line BRCA-1 mutations are more likely to be triple negative and high grade [6]. Gene expression studies have confirmed this phenomenon and BRCA-1-associated breast cancer appear to cluster in the basal-like subtype [7].

Pathological and molecular featuresAlthough triple negative breast cancer and basal-like breast cancers are terms that are often used interchangeably, it very important to realise that they are not the same. TNBC refers to the immunophenotype of the breast cancer, which is immunologically negative to ER, PR and HER2. Such immunological stud-ies are carried out on formalin-fixed and par-affin-embedded tumour sections. Basal-like breast cancer refers to the molecular pheno-type of the tumour that has been defined by cDNA microarrays. Of these triple negative breast cancers, about 75% of them are of the basal-like type.

Perou et al were the first to describe the vari-ous molecular subtypes or molecular pro-files of breast cancers. They described four subtypes of breast cancer based upon cDNA microarrays, including a basal-like subtype of breast cancer. Most triple negative breast cancers clustered in the basal-like subtype [8]. Since then, multiple studies of gene expression profiling have furthered the understanding of the molecular diagnosis of breast cancer, pro-viding the background for oncologists to use

triple negative breast cancer (tNBC)Currently the focus of much clinical, scientific and media attention, triple negative breast cancer (tNBC) is not a new type of cancer, but rather a subtype of breast cancer that is defined by the lack of the expression of estrogen receptor(ER), pro-gesterone receptor (PR) and HER2 protein. Particularly prevalent in pre-menopausal women of African origin, tNBC has a very poor prognosis. this article reviews the epidemiology, molecular pathology and clinical aspects of tNBC and describe possible new therapeutic approaches.

by dr Roohi ismail-Khan


Black women were found to be almost 3-fold more likely than white women to have triple negative breast cancer.

21

the triple negative phenotype to describe the basal-like molecular subtype [7, 9-11].

The luminal subtypes of breast cancers express high amounts of luminal cytokeratins and express genetic markers of luminal epi-thelial cells and normal breast cells [12, 13]. In contrast, basal-like breast cancers are so named because they tend to express cytokeratins associated with basal types of cancers, as they arise from the outer basal layer. In general, basal-like breast carci-nomas are morphologically con-sistent with a high nuclear grade, high mitotic count and necrosis, such as a grade 3 invasive ductal carcinoma, not otherwise speci-fied. Some have the histomor-phology of medullary carcinoma or metaplastic carcinoma. It has also been demonstrated that almost 82 percent of basal-like breast cancers express p53, com-pared to only 13 percent in the luminal A subgroup [10].

It is important to realise that TNBC and basal-like breast can-cer are not all of high histological grade. For low grade tumours, the clinical management strategies outlined in this article are not applicable. Oncologists therefore need to be aware of this when using triple negative to define a potentially aggressive group of breast cancers. Although the majority of triple negative breast cancers are basal-like and the majority of basal-like breast can-cers are triple negative, there is a about a 25 percent discord-ance between the two descrip-tive subgroups [4]. However, for the remainder of this article, we will use the TNBC phenotype to represent this molecular subtype.

Clinical course and prognosisTriple negative breast carcino-mas are known to be biologically aggressive. Although it has been suggested that they respond to chemotherapy better than other types of breast cancer, prog-nosis remains very poor [14]. This can be explained by two factors: shortened disease-free interval in the adjuvant and the

neo-adjuvant setting and more aggressive clinical course in the metastatic setting.

Triple negative tumours have a very good initial response to chemotherapy, particularly anthracycline- and taxane-based therapy. Although these tumours are initially sensitive to stand-ard neoadjuvant chemotherapy, they continue to exhibit a very short disease-free survival [15]. Recently published neoadju-vant studies have clarified the fact that patients who have a good pathological outcome from surgery also have a good clini-cal response. However, within the group of patients who have residual disease after complet-ing neoadjuvant chemotherapy, the worst prognosis is seen in the triple negative subgroup [16].

Even in early stage TNBC, early relapse is very common. It has been noted that there is a predi-lection for visceral metastases, including lung, liver, and nota-bly, brain metastases. Current estimates are that approximately 15 percent of TNBC patients develop brain metastases. Patients with TNBC have a higher risk for developing cerebral metastases when compared to other types of breast cancer. Studies show that even in patients with cer-ebral metastases, TNBC patients have a poorer prognosis, as metastasis to the brain occurred earlier [17].

According to NCCN guidelines, treatment of T1N0 breast cancer is based both on tumour size and cellular characteristics. Oncolo-gists tend to treat patients with T1N0 triple negative breast can-cer with more aggressive chemo-therapy, both in the neoadju-vant and the adjuvant setting. When examining the number of patients treated and also the type of adjuvant chemotherapy administered, triple negative T1N0 patients have greater risk of recurrence in spite of this more aggressive therapy. Patients with T1N0 TNBC have twice the risk of recurrence, in spite of receiving much more aggressive treatment [15, 18].

In addition to having a very short disease-free survival, triple nega-tive breast tumours are aggressive in the metastatic setting, signifi-cantly contributing to the short-ened overall survival [3]. Progres-sion-free survival is estimated to be four months at best in TNBC for first line therapy, even with Avastin-based therapy [19].

Hope for targeted therapy and future directions in researchAs discussed in this paper, although TNBC is sensitive to chemotherapy, early relapse is more likely than in other subtypes, and visceral metastasis, includ-ing brain metastasis, is very com-monly seen. Targeted agents that

are currently being investigated include epidermal growth fac-tor receptor (EGFR), vascular endothelial growth factor (VEGF) and poly (ADP-ribose) polymer-ase (PARP) inhibitors [19].

The anti-angiogenic agent beva-cizumab (Avastin), a monoclonal antibody targeting vascular endothelial growth factor (VEGF), is active in many solid tumours including breast cancer. Miller et al demonstrated a significant improvement in progression-free survival (11.8 vs 5.9 months, HR = 0.60, P <.001) when adding bevacizumab to paclitaxel chemo-therapy compared with single-agent paclitaxel alone in first-line treatment of metastatic disease.



Examining the TNBC subset of patients in this study confirmed the same improvement (HR = 0.53, 95% confidence interval = 0.40–0.70)[19, 20]. It is safe to say that most oncologists, including myself, would strongly consider an Avastin combination for first line therapy when treating patients with metastatic triple negative breast cancer.

The fact that the majority of BRCA1-asso-ciated breast cancers are also triple-negative and basal-like leads researchers to wonder about the extent to which the BRCA1 path-way contributes to the behaviour of “spo-radic” basal-like breast cancers. It has been shown that basal-like breast carcinomas frequently harbour defects in DNA double-strand break repair through homologous recombination such as BRCA1 dysfunction. The DNA-repair defects characteristic of BRCA1-deficient cells confer sensitivity to poly (ADP-ribose) polymerase 1 (PARP1) inhibition [21].

PARP1 is a gene that encodes a chromatin associated enzyme that modifies various nuclear proteins. This gene is involved in the molecular events leading to cell recovery from DNA damage. When PARP1 is inhib-ited, double-strand DNA breaks accumu-late that, under normal conditions, would be repaired via homologous recombination. Both BRCA1 and BRCA2 are required for the homologous recombination pathway to function properly. Therefore, cells deficient in either BRCA1 or BRCA2 are very sensi-tive to PARP1 inhibition, resulting in cell death and apoptosis. Intuitively, inhibition of the PARP pathway should be of benefit to patients with BRCA-associated malignancies [22]. However, as stated above, not all TNBC are associated with BRCA mutations.

Several PARP1 inhibitors are currently in clini-cal development and hold promise in basal-like and TNBC breast cancers. As presented in the plenary session of the American Soci-ety of Clinical Oncology (ASCO) meeting in 2009, the results of a randomised phase II study with BSI-201 (a PARP Inhibitor) showed benefit in patients with TNBC who had two or fewer previous lines of chemotherapy. When BSI-201 was combined with gemcitabine and carboplatin, the clinical benefit rate improved to 62 percent when compared to the gemcit-abine and carboplatin alone arm at 21 percent (p<0002) [23]. (Clinical benefit rate is defined as complete response plus partial response plus stable disease lasting six months or more). In addition, the overall response rate was nota-bly improved in the BSI-201 arm at 48 percent compared to the control arm at 16 percent. Progression-free survival was improved to 6.9 months in the BSI-201 arm of the study versus 3.3 months in the gemcitabine and carboplatin alone arm [23]. This initial positive study has led researchers to examine the use of PARP inhibitors in the treatment of TNBC and many such studies are ongoing. In addition, there are many new agents that are being investigated that may potentially provide promise in this subgroup of breast cancer patients.

References1. Jemal A et al. CA Cancer J Clin 2009; 59(4): p.

225-49.2. Kaplan HG & Atwood MK San Antonio Breast

Cancer Symposium, 2006(December 2006): p. poster session VI.

3. Anders CK & Carey LA. Clin Breast Cancer;2009; 9: S73.

4. Rakha EA et al. J Clin Oncol 2008; 26: 2568.5. Carey LA et al. JAMA 2006; 295: 2492.6. Lakhani SR. et al. J Clin Oncol 2002; 20: 2310.7. Sorlie T et al. Proc Natl Acad Sci USA 2003;

100: 8418.8. Perou CM et al. Nature 2000; 406: 747.9. Sorlie T et al. Mol Cancer Ther 2006; 5: 2914.10. Sorlie T et al. Proc Natl Acad Sci USA 2001; 98:

10869.11. Sorlie, T. et al. BMC Genomics 2006; 7: 127.12. Rakha EA et al. Cancer 2007; 109: 25.13. Sotiriou C and Pusztai L N Engl J Med 2009; 360:

790.14. De Giorgi U et al. Ann Oncol 2007; 18: 202.15. Kaplan HG & Atwood MK, T1N0 Triple Negative

Breast Cancer: Adjuvant Chemotherapy Treat-ment and Risk of Recurrence. San Antonio Breast Cancer Symposium, 2007. Abstract 3070.

16. Carey LA et al. Clin Cancer Res 2007; 13: 2329.17. Heitz F et al Cerebral metastases (CM) in breast

cancer (BC) with focus on triple-negative tumours. in ASCO meeting 2008. Chicago.

18. Kaplan HG et al. Breast J 2009; 15: 454.19. Miller K et al. N Engl J Med 2007; 357: 2666.20. Siziopikou KP & Cobleigh M. Breast 2007;16:

104.21. Rottenberg S et al. Proc Natl Acad Sci USA 2008.

105: 17079.22. Farmer H et al. Nature 2005; 434(7035): p.

917-21.23. O’Shaughnessy J et al. Efficacy of BSI-201, a poly

(ADP-ribose) polymerase-1 (PARP1) inhibitor, in combination with gemcitabine/carboplatin (G/C) in patients with metastatic triple-negative breast cancer (TNBC): Results of a randomized phase II trial. in ASCO 2009 annual meeting. Orlando, Florida.

The authorRoohi Ismail-Khan, MDAssistant ProfessorDivision of Breast Oncology &Experimental TherapeuticsH. Lee Moffitt Cancer CenterTel: +1 813 745 4933Fax: +1 813 745 7287e-mail: [email protected]

22 – September/October 2010 WoMEN’s HEALtH

Several urological groups initially used a variety of terms to describe the technique now defined as LESS [2]. LESS appears to provide several of the benefits of NOTES, with enhanced cosmesis and decreased abdominal wall trauma, without the added risks and difficulty encountered by traversing a natural orifice. It might include a single laparoscopic access port, an access plat-form with several channels for instrumentation or a single skin incision through which several separate ports can be placed through separate fascial incisions. From a cosmetic standpoint LESS may be ideally performed via the umbili-cus, an embryonic remnant of development [3].

Urologists have been at the forefront of mini-mally invasive surgery for 25 years. Stones that were formerly managed with open lithotomy are now approached with shockwave lithot-ripsy (SWL), ureteroscopy and percutaneous techniques. Large, obstructing prostate glands once managed with open prostatectomy are now routinely managed endoscopically. Thus, urologists are uniquely equipped with the skill sets necessary to perform pure NOTES or LESS because they have experience in both endos-copy and surgery [1].

Access techniques and instrumentationIn the debate regarding the best portal for performing NOTES, several factors need to be considered: ease of access, ease of clo-sure, potential for infectious complications, security of closure, severity of complications related to closure failure, maximum diam-eter for instrument insertion and specimen removal, and the relationship to the target

anatomy. NOTES has thus far been success-fully completed experimentally by the trans-gastric transvaginal, transcolonic, and trans-vesical routes [4]. A single NOTES access raises limitations while performing complex urologic procedures related to exposure, organ retraction, grasping and limited trian-gulation. The concept of effectively combin-ing transgastric and transvesical access was demonstrated by Lima et al, who performed a pure NOTES nephrectomy in a non-sur-vival porcine model. Overall, the logistics of NOTES surgery are universal: (i) the natu-ral orifice is accessed with the aid of a flex-ible multichannel scope; (ii) incision is made through the visceral wall using a needle-knife;

(iii) a wire is passed into the peritoneal cav-ity using a modified Seldinger technique; (iv) a dilating balloon is variably used to obtain a suitable access tract; (v) a catheter, guide tube or overtube is placed over the guide-wire and insufflation is achieved with CO2; (vi) scope is advanced into the peritoneal cavity; and (vii) viscerotomy is closed [3].

LESS access can be obtained either by per-forming a single-skin and fascial incision, through which a single multichannel access platform is placed (single-port surgery), or by placing several low-profile ports through separate fascial incisions (single-site sur-gery). The access point can be umbilical or extraumbilical [2]. Despite being an evolu-tion of standard laparoscopic surgery, LESS defies the most basic tenets of laparoscopy including triangulation of working instru-ments and external spacing to decrease intra- and extracorporeal clashing [5]. Several mul-tichannel platforms have been developed and used for LESS in urological surgery [Figure 1]. Standard laparoscopic instrumentation may be used in this setting but often articu-lating or curved instruments can be benefi-cial for providing triangulation with reduced clashing of instruments [6]. In some cases this may require counterintuitive movements when the surgeon’s instruments may cross each other. The use of digital in-line laparo-scopes with only one cord in parallel is also beneficial for LESS, as additional cords with

LEss and NotEs: applications in urological surgeryLaparoendoscopic single site surgery (LEss) and natural orifice transluminal endo-scopic surgery (NotEs) represent novel approaches in minimally invasive surgery. A common underlying ‘‘hypothesis’’ has driven their development—namely, that a reduction in the number of transcutaneous points of access may benefit patients in terms of port-related complications, recovery time, pain and cosmesis by poten-tially performing scarless surgery [1].NotEs involves diagnostic or therapeutic interventions performed via existing ori-fices of the human body (mouth, anus, urethra, vagina). Although a pure NotEs procedure is performed without transabdominal access, the use of accessory transabdominal ports has been regarded as part of the evolution of NotEs and defined as hybrid NotEs [2].

by dr Carmelo Quattrone, dr Carmine di Palma, dr Marco de sio, dr Estevão Lima, dr Jihad H. Kaouk and dr Riccardo Autorino

23MiNiMALLY iNVAsiVE sURGERY – September/October 2010

Figure 1. Novel platforms and instruments for LESS.

perpendicular insertion into the scope inter-fere with other instruments and the surgeon’s movements when space is at a premium [7].

Preclinical experienceThe field of NOTES in urology has been exten-sively explored in experimental setting, mostly using porcine animal model. Clayman et al reported transvaginal nephrectomy performed using a purpose-built, multi-lumen operating platform [8]. Haber et al assessed the feasibility of pure NOTES transvaginal nephrectomy in a porcine model using NOTES-specific instru-mentation without transabdominal ports [9]. In the field of nephron-sparing surgery, Crouzet et al presented their laboratory experience with NOTES renal cryoablation in pigs performed with either a transgastric or transvaginal approach [10]. Boylu et al assessed the feasibil-ity of NOTES transgastric partial nephrectomy (PN) without hilar clamping [11]. Humphreys et al reported their preliminary experience with the technical development of NOTES RP in a cadaver model [12]. A pure NOTES approach for partial cystectomy has also recently been described by using either a transurethral or a transgastric approach [13].

Raman and colleagues presented a pioneering study of LESS for nephrectomy that included seven successful experimental nephrectomies on pigs followed by three clinical procedures [14]. Before embarking on their first clinical procedure, Barret et al. reported their experi-ence with LESS extraperitoneal radical prostate-ctomy in a cadaver model, using both standard and articulated laparoscopic instruments [15]. More recently, Boylu et al. determined the fea-sibility, instrumentation and learning curve for LESS partial nephrectomy in a pig model [16].

Clinical experienceAdvances in instrument technology, together with increasing experience in NOTES and

LESS approaches, have driven the transition from porcine models to the human. Clinically, NOTES experience has been much more lim-ited than LESS. The first two cases of single-port surgery in urology were reported by Rane et al. in abstract form, at the 2007 World Con-gress of Endourology [17]. In the same period, the first multitrocar single-incision transum-bilical nephrectomy was reported by Raman et al. Following an initial porcine feasibility dem-onstration, three human nephrectomies were performed: two for benign nonfunction and one for clear-cell carcinoma [14].

Since then, several other clinical series have been reported by a few groups worldwide with an estimated cumulative clinical experience of more than 500 cases. Nowadays the entire spec-trum of urological procedures, both for upper and lower urinary tract diseases, has been described and shown to be feasible, including advanced reconstructive procedures and major extirpative ones. Comparative series between conventional laparoscopy and LESS have recently become available [Table 1]. Raman et al were the first to report a case-control study comparing LESS with conventional laparos-copy. They compared LESS nephrectomies with conventional laparoscopic nephrectomies. No differences in operative time, postoperative hospital stay, narcotic analgesic use, compli-cation rate or transfusion requirement were observed between the two techniques. How-ever, estimated blood loss was significantly lower in the LESS group than in the conven-tional laparoscopy group. The authors con-cluded that the superiority of LESS nephrec-tomy over standard laparoscopy was limited to a mere subjective cosmetic advantage. Starting from the consideration that in this first study half of the LESS patients had a nephrectomy for malignancy, necessitating extension of the ini-tial umbilical incision for specimen extraction, the same group of investigators speculated that

this may have blunted the potential benefit of LESS [18].

Raybourn et al matched a total of 11 patients undergoing LESS laparoscopic simple nephrec-tomy with a group of 10 patients who previously underwent simple nephrectomies. All LESS simple nephrectomy procedures were com-pleted uneventfully. There were no intraopera-tive complications in the LESS group. Postop-erative complications included pyrexia and port site bruising in two patients. Operative time and narcotic analgesia requirements were not significantly different between the two groups [19]. Jeong et al recently described the first study comparing LESS vs laparoscopy in the treatment of benign adrenal adenoma. No significant dif-ferences in the mean operative time, blood loss or postoperative hospital stay were observed between the groups [20]. Finally, Canes et al reported the first retrospective matched-pair comparison of LESS to standard laparoscopic live-donor nephrectomy. Mean warm ischemia time was significantly longer in the LESS group (3 vs 6.1 min), even if allograft function was comparable between groups at three months. Patients undergoing LESS donor nephrectomy had similar in-hospital analgesic requirements and mean visual analogue scores at discharge. After discharge, their convalescence, as evalu-ated by using visual analog pain scores and questionnaires containing patient-reported time to recovery end-points was faster, including days on oral pain medication, days off work and days to full physical recovery [21].

So far, all comparative studies have been lim-ited by small numbers, their nonrandomised design, their retrospective nature, and the lack of standardisation in the assessment of post-operative outcomes. Overall, these series have shown a non-inferiority of LESS over conven-tional laparoscopy in terms of perioperative outcomes, with an encouraging trend toward less postoperative pain and better cosmesis.

LESS/NOTES development: further stepsSeveral questions must be answered before

24 MiNiMALLY iNVAsiVE sURGERY – September/October 2010

Table 1. LESS vs laparoscopy: comparative studies in urology.

Figure 2. The place for LESS and NOTES in minimally invasive urological surgery.

25

LESS and NOTES could gain widespread acceptance: do LESS and NOTES provide any objective, reproducible benefit over conventional or robot-assisted laparoscopy? And which patient population is most likely to benefit from LESS and NOTES? Further comparative analyses are still needed to answer these questions. Even if there is a universal agreement that improved cosmesis is clinically apparent, standardised measures have not yet been employed to scientifically verify these findings. The true marker for its acceptance will likely be whether LESS and NOTES show reduced pain, morbidity and convalescence, thus justifying the related increase in technical demands and costs. In this respect, well-designed prospective trials are awaited to compare LESS and NOTES to conventional laparoscopy, including appropriate quality of life (QoL) and outcome analyses, especially in terms of cosmetic benefit, by using validated patient-reported outcome instruments.

Finally, as the role of robotic surgery is rapidly growing in urology and it is expected that robotics will progressively replace standard laparoscopy, it will be important to see how robotic technology will affect the devel-opment of LESS and NOTES. Robotic instruments dedicated to LESS and NOTES have recently been introduced and are currently under eval-uation [22]. New robotic systems, including master–slave systems, flex-ible robots, in vivo miniature robots or a combination of those systems, might bring NOTES to its full potential in the future.

ConclusionsEarly clinical experience has shown that NOTES urologic surgery using currently available instruments is indeed possible. Nevertheless, because of the immaturity of the instrumentation, early cases have demanded a technical virtuosity that still precludes widespread application of this approach. Clinical experience to date has indicated that LESS surgery can safely and effectively be performed in a variety of urologic settings. As clinical experience increases, expanding indications are expected to be documented and the efficacy of the procedure to improve. Fur-ther clinical research, based on sound scientific principles, will define the actual place of LESS in urologists’ armamentarium [Figure 2]. In the meanwhile, it should be recommended that, together with proper patient selection, a surgeon possess adequate laparoscopic experience and preferably a certain amount of LESS training before embarking on a LESS procedure. This is of utmost importance for minimising serious complications, such as those seen in early reported series.

References1. Gettman MT, Box G, Averch T et al. Eur Urol 2008; 53: 1117–20.2. Box G, Averch T, Cadeddu J et al. J Endourol 2008; 22: 2575–81.3. White WM, Haber GP, Doerr MJ et al. Urol Clin North Am 2009; 36: 147–55.vii.4. Box GN, Bessler M, Clayman RV. J Endourol 2009; 23: 753–7.5. Canes D, Desai MM, Aron M et al. Eur Urol 2008; 54: 1020–30.6. Kommu S, Rane A. Expert. Rev. Med. Devices 2009; 6: 95–103.7. Branco AW, Kondo W, Stunitz L et al. BJU Int 2009; 104: 1136–42.8. Clayman RV, Box GN, Abraham JB et al. J Endourol 2007; 21: 640–4.9. Haber GP, Brethauer S, Crouzet S et al. BJU Int. 2009; 104: 1260–4.10. Crouzet S, Haber GP, Kamoi K et al. BJU Int 2008; 102: 1715–18.11. Boylu U, Oommen M, Joshi V et al. Surg Endosc 2009; 24: 485–9.12. Humphreys MR, Krambeck AE, Andrews PE et al. J Endourol 2009; 23:

669–75.13. Sawyer MD, Cherullo EE, Elmunzer BJ et al. Urology 2009; 74: 1049–53.14. Raman JD, Bensalah K, Bagrodia A et al. Urology 2007; 70: 1039–42.15. Barret E, Sanchez-Salas R, Kasraeian A et al. J Endourol 2009; 23: 135–40.16. Boylu U, Oommen M, Thomas R et al. BJU Int 2009; doi:10.1111/j.1464-

410X. 2009.08916.x.17. Rane A, Kommu S, Eddy B et al. J. Endourol 2007; 21 (Suppl 1): A22–3.18. Raman JD, Bagrodia A, Cadeddu JA. Eur Urol 2009;55:1198–20419. Raybourn 3rd JH, Rane A, Sundaram CP. Urology 2010;75:100–3.20. Jeong BC, Park YH, Han DH et al. J Endourol 2009; 23: 1957–60.

21. Canes D, Berger A, Aron M et al. Eur Urol 2009; doi: 10.1016/j.eururo.2009.07.023.

22. Haber G, White MA, Autorino R et al. Novel robotic daVinci instruments for laparoendoscopic single-site surgery. Urology (In press).

The authorsCarmelo Quattrone1, Carmine Di Palma1, Marco De Sio1, Estevão Lima2, Jihad H. Kaouk3 and Riccardo Autorino1,3

1Urology Clinic, Second University of Naples, Naples, Italy2Life and Health Sciences Research Institute, School of Health Sciences, University of Minho, Braga, Portugal3Section of Advanced Laparoscopy and Robotics, Glickman Urological Institute, Cleveland Clinic, Cleveland, USA

Correspondence to:Riccardo Autorino, MD, PhD, FEBUClinica Urologica, AOU Policlinico SUNPiazza Miraglia 280138 Naples, Italye-mail: [email protected]


For physicians,

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allied healthcare

professionals

www.esicm.org

23rd AnnuAl Congress

CCIB - BArCelonA - spAIn

9 - 13 oCtoBer 2010

For more information, contact

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ESICM-BA10-101x178.indd 1 20/08/10 11:08:35

26 sCiENtiFiC LitERAtURE REViEW

Imaging features of encapsulating peritoneal sclerosis in continuous ambulatory peritoneal dialysis patients.This article presents the spectrum of radio-logic findings of encapsulating peritoneal sclerosis in patients undergoing continu-ous ambulatory peritoneal dialysis (CAPD). Although a rare diagnosis, encapsulating peritoneal sclerosis in patients undergoing CAPD has a high morbidity and mortality. Diagnosis is often delayed because clini-cal features are insidious and nonspecific. Radiologic imaging may be helpful in the early diagnosis of encapsulating peritoneal sclerosis and in facilitating timely interven-tion for CAPD patients with encapsulating peritoneal sclerosis.Ti JP et al. Am J Roentgenol 2010;195:W50.

Peritoneal dialysis without a physical peritoneal dialysis unit.Under certain circumstances when patients need peritoneal dialysis (PD) but no physical unit or official staff are available, improvi-sation is needed. This study describes the authors’ experience with such patients in the absence of a physical peritoneal dialy-sis unit. Since 1997 33 patients, mean age 61.7 +/- 12.8 years old, have been trained in PD. Catheter implantation was carried out on an out-patient basis in another hospital. Trained nurses, made available by the com-pany supplying the PD solution, were used. After 2004, the entire training took place at patients’ homes.

Catheter implantation was successful in all 33 patients. The catheter was removed from two patients (one and four years after implanta-tion) because of relapsing peritonitis and fun-gal infection respectively. The overall rate of

peritonitis was 0.18 episodes per patient year. Patient survival was 90%, at one year, 83% at two years and 55% at three years. Grapsa EI et al. Clin Nephrol 2010; 73:449.

Early initiation of continuous ambulatory peritoneal dialysis in patients undergoing surgical implantation of Tenckhoff cathetersNephrologists commonly recommend continu-ous ambulatory peritoneal dialysis (CAPD) with break-in periods of at least two weeks. This study investigated the safety and feasibility of shorter break-in periods following surgical implanta-tion of Tenckhoff catheters. Three hundred and ten patients who underwent Tenckhoff catheter implantation for the first time were examined retrospectively. An ‘early’ group comprised 226 patients who started CAPD ≤ 14 days after implantation; the other ‘late’ group comprised 84 patients who started CAPD > 14 days after implantation. Catheter-related complications within six months were analysed.

The time to CAPD initiation was shorter in the early group (2.0 ± 2.7 days) than in the late group (40.6 ± 42.8 days) (p < 0.001). The bridge hemodialysis rate was higher in the late group (57.1%) than in the early group (31.4%) (p < 0.001). Overall, 33 early-group (14.6%) and 11 late-group patients (13.1%) developed catheter-related complications within six months. The early-group complications were leakage (n = 5), diminished outflow volume (n = 7), migration (n = 7), pericatheter hernia (n = 1), hemoperitoneum (n = 1), pericatheter infection (n = 3) and peritonitis (n = 9). The late-group complications were leakage (n = 2), diminished outflow volume (n = 5), migration (n = 2), and peritonitis (n = 2). Freedom from catheter-related complications was similar in both groups. The authors coclude that early initiation of CAPD with surgically implanted Tenckhoff catheters is feasible and safe. Shorter break-in periods are not associated with more catheter-related complications. The data sug-gest that early initiation is not associated with an increased number of complications, but this needs to be confirmed in a randomised trial.Yang YF et al. Perit Dial Int 2010 Jun 30.

The impact of dialysis modality on arterial stiffness in patients with end-stage renal disease.Arterial stiffness determined by brachial-ankle pulse wave velocity (baPWV) has been

established as a powerful predictor of car-diovascular mortality in hemodialysis (HD) patients. There are, however, few studies regarding the comparative impact of different renal replacement therapies (RRTs) on pulse wave velocity,PWV. This cross-sectional study compared arterial wall properties and cardiac function between patients treated with continuous ambulatory peritoneal dial-ysis (CAPD) and those with HD. Patients were matched for age, dialysis duration and blood pressure. Transthoracic echocardiog-raphy (TTE) and baPWV were performed in HD patients (n = 23) after 1 h of a midweek dialysis session and in CAPD patients (n = 26) with an empty abdomen after drainage of dialysate. The baseline data were retrospec-tively reviewed. It was found that baPWV was significantly higher in HD patients than in CAPD patients (18.1 ± 2.8 vs. 16.1 ± 2.7 m/s, p = 0.015). TTE revealed a signifi-cantly increased E/E’, left atrial volume index (LAVI) and inferior vena cava (IVC) diameter index in HD patients compared with CAPD patients (p < 0.05). In a multivariate regres-sion analysis adjusted for dialysis modality, age, systolic BP, residual glomerular filtration rate, diabetes and echocardiographic param-eters, HD was independently associated with increased baPWV. This study shows that HD patients had significantly increased arterial stiffness and severe diastolic dysfunction compared with CAPD patients.Chang JH et al. Ren Fail. 2010;32:947.

A case of rare, fungal peritonitis caused by Histoplasma capsulatum in a patient on CAPD. A 62-year-old man with a history of end-stage renal disease secondary to hypertension who was on continuous ambulatory peritoneal dialysis (CAPD), presented to the peritoneal dialysis clinic with subacute onset of abdom-inal pain, mainly in the epigastric region. A full medical history, physical examination, laboratory tests, cultures of peritoneal dialy-sis fluid, radiography, ultrasonography and CT scanning of the abdomen and pelvis was carried out. Following these investigations a diagnosis of fungal peritonitis caused by infection with Histoplasma capsulatum was made. The peritoneal dialysis catheter was removed and the patient was treated with itraconazole for six months.Ijaz A & Choudhury D. Nat Rev Nephrol 2010; 6: 435.

Ambulatory patient care: a selection of peer-reviewed literaturethe number of peer-reviewed papers covering the vast field of ambulatory patient care is huge, to such an extent that it is frequently difficult for health-care professionals to keep up with the literature. As a special service to our readers, iHE presents a few key literature abstracts from the clinical and scientific literature chosen by our editorial board as being particularly worthy of attention.

– Issue N°1 – Feb./Mar. 2010

28 HEALtHCARE FACiLitY sPotLiGHt

Q: Allied Diagnostics have several facilities in the Gulf area. Where precisely are the centres and which geographical and population area do the centres serve?Currently Allied Diagnostics’ facilities are located in the Dubai and Sharjah emirates of the United Arab Emirates (UAE), Muscat and Salalah in the Sultanate of Oman, and Riyadh in the Kingdom of Saudi Arabia (KSA). Our major, hub sites are Dubai, Muscat and Riy-adh, with the Riyadh site being the newest and biggest.

In the UAE, our centres located in Dubai and Sharjah cover mostly these two emirates but we also receive patients from all the other emirates in the area, especially for our specialty services like non-invasive cardiac imaging and breast imaging. In Oman, we receive patients from over the whole country for specialized CT and MRI studies, particularly in Muscat where we have a hospital-based centre.In both Oman and the UAE we serve not only the local population, but also the relatively large expatriate population (mostly Western, Arabic, Indian and southeast Asian).

Q: How are all these centres staffed? For example, how many radiologists or other medically qualified personnel do you have? What about support staff?In our Dubai centre we have one nurse and three clinicians, namely a cardiologist and two radi-ologists whose subspecialties are neuro, muscu-loskeletal, women and chest imaging. I am the cardiologist and my subspecialty is non invasive cardiovascular imaging (CT and MRI of the heart and vessels). I split my time between the two sites of Dubai and Muscat (three days at each site per week). Supporting all this we have more than ten radiographers covering different spe-cialities such as CT/MRI, ultrasonography and general radiology. The cross-section of nation-alities we have in our medical staff mirrors that of Dubai itself and so is a mixture of Western, Asian and Arabic. All clinicians are western-trained or certified (most of them from the US, UK or France). As for the radiographers, some are western-trained and some locally trained. The latter work under the supervision of their internationally trained colleagues until they are judged able to work on their own and deliver a service up to international standards.

We see all kinds of cases, from adult to pediatric, and from general to cases requiring specialised studies. Allied Diagnostics has an excellent rep-utation and is well-known for its high standards in the carrying out and reporting of diagnostic procedures, so a large part of the requests we receive fall into the categories of subspecial-ties such as cardiovascular, womens’ health and breast, musculoskeletal and neuro-imaging. We also get a lot of referrals for second opinions on procedures originally done elsewhere.

Q: As regards instrumentation to support all these activities, how are you equipped? In all Allied Diagnostics centres we have the latest state-of-the-art equipment so that we can deliver absolute top quality images with high diagnostic accuracy to enable our radiologists to provide best possible patient care in the safest way. In our Dubai facility we have the only low radia-tion CT system in the UAE; this is the 64-slice CT Lightspeed VCT-XTe from GE Healthcare. In September 2009, this CT was upgraded with the low radiation option, the so-called Adapta-tive Statistical Iterative Reconstruction (ASIR) system and prospective triggering for cardiac studies. Since the installation of the ASIR update we can deliver high resolution 2D and 3D images with up to 50% less radiation dose compared to conventional 64-slice CT in body imaging and up to 85% less radiation in cardiac studies. The equipment ensures that our practice standards are kept up to the highest international levels, which is particularly important in the context of the concerns raised recently regarding radiation dangers involved in medical procedures.As for magnetic resonance, we have a GE 1.5 Tesla MRI HDx (with a high field closed mag-net) which means we can offer our patients the most advanced high field system and give high accuracy. The system is ideal for specialized or difficult cases. For claustrophobic patients we also have the possibility of an open MRI, namely a GE 0.35 Tesla MRI/ signa ovation which has a low field open magnet. In addition to the CT and MRI systems, we have three state-of-the-art ultrasound machines (GE Voluson E8/) that deliver high definition 3D and 4D images.We also provide digital mammography and radi-ography services as well as dental imaging and bone density studies for osteoporosis screening and monitoring.All our centres are equipped with PACS systems for easy and safe digital storage of our diagnostic procedures, as well as for simple communica-tion and access to old exams. The implementa-tion of the PACS system was key in our move to a completely digital environment where patient

High quality imaging in the Gulf Regionthe Gulf region of the Middle East is renowned as being a centre of dynamic development, even in these current times of worldwide economic slowdown. international Hospital (iHE) wanted to find out how imaging healthcare services are developing in this fast-growing region so we spoke to dr Rami Neemtal-lah, Medical director of Allied diagnostics, who have several state-of-the-art facilities with the latest equipment in diagnostic imaging.


Sophisticated equipment is useless without qualified personnel to operate it. At Allied Diagnostics’ facilities in Dubai, the medical radiology staff is backed up by a team of radiographers and support personnel, whose

nationalities reflect those of Dubai itself, namely Western, Arabic, Indian and southeast Asian.

29

confidentiality is strictly observed and the high-est standard of patient care provided.The PACS is also a central component in our project to link all our centres (and also the referring clinics and clinicians) to our main database so that secure, remote access to patients’ images and reports can be provided in a timely manner

Q: In this context, what about links and/or collaborations with other centres?As I said, we are well known for the quality of the services we provide at the highest international standards throughout the Gulf region and also for the delivery of specialty services not widely available in this region. Thanks to this reputa-tion, many clinics and hospitals (especially those unable to provide service in their own premises) use Allied Diagnostics for their diagnostic needs. Many clinics also refer patients with complicated pathologies to us for second opinion.

Q: How do you see the future? As regards our equipment, we make continual efforts to make sure we have access to the latest technology via new equipment and new software

updates for our workstations so that we can keep up to date with the latest advances in radiology. One of the major projects that we are putting in place this year is total connectivity between all our sites throughout the Gulf region for easy sharing of patient images, particularly in cases where a second or more specialised opinion is required. In this way our major referring clin-ics and hospitals can have direct access to their patients’ images and to our medical staff.In terms of new facilities, we plan to expand over the next few years by opening new centres in other cities in the region.

Q: It appears that, because of your state-of-the-art technology and standards of prac-tice, Allied Diagnostics has been nominated as a cardiac imaging and demonstration and training site for the Middle East? What exactly does this entail?In practice this means that the Allied Diagnostics center in Dubai is a recognised demonstration and training site for CT in general and cardio-vascular imaging in particular. Thus, we regu-larly receive people from other hospitals who are interested in seeing how our equipment operates under real-life, routine conditions, as well as of course seeing the quality of the images and how they are processed and reported. We regu-larly receive clinicians and radiographers who come to us to be trained on new technologies; we give practical training on image acquisition and interpretation using the latest software on our workstation and we also give lecture series covering all aspects of the new techniques.

Q: In contrast to the standalone Dubai facil-ity, your Muscat operation is hospital-based. How many beds do you have?Yes, Allied Diagnostics run the radiology depart-ment in the Muscat Private Hospital (MPH), which is the biggest private medical institution in Oman. The hospital was built approximately 10 years ago and has around 100 beds and several

departments, e.g emergency, outpatient and pediatrics as well as womens’ services, intensive care and internal medicine departments.There is also an operating and surgery block and a physi-otherapy department. MPH is actively expand-ing some of its specialty services, in particular cardiology and cardiac surgery (MPH is the only private institution in Oman to do cardiac surgery), comprehensive womens’ medicine services, general, orthopedic and cosmetic sur-gery. As for the radiology facilites in Muscat, we are equipped with roughly the same systems as in our Dubai facility, although the services we provide in Muscat are of even greater impor-tance in Oman because sub-specialty medical services there are less available than in Dubai. The MPH hospital is also in the process of quailifying for Joint commission International (JCI) accreditation.

Q: Apart from Muscat and Dubai, what about your other facilities in the region? Allied Diagnostics has recently opened our new-est centre, which is in the city of Riyadh (KSA). This facility has the newest generation of mul-tislice CT from GE Healthcare, namely the Dis-covery CT750 HD with increased image reso-lution and lower radiation exposure, and a GE 3T High Definition MRI, and the latest PET CT, also from GE, as well as ultrasound and general radiography. With this range of instrumentation, the Riyadh facility has the most advanced equip-ment of our group. We have other centres in the Middle East and Gulf region, namely in Sharjah and Salalah where we provide MRI, ultrasound and mammography services.

For more information on Allied Diagnostics in the Gulf Region, contact

Dr Rami NeemtallahMedical Director, Allied Diagnostics, Po Box 32442, Dubai, UAE Tel.: 00971 4 3328111email [email protected]


The flagship equipment in the Dubai facility of Allied Diagnostics is the 64-slice Lightspeed VCT-XTe CT system from GE Healthcare, which is fitted with the Adaptive

Statistical Iterative Reconstruction (ASIR) system. This enables high resolution 2D and 3D images to be gener-ated at much less radiation levels than with conventional

64-slice CT.

The Allied Diagnostics standalone facility in Dubai receives patients from not only the local population but also from the Gulf expatriate population.

As a recognised demonstration and training site for CT in general and cardiovascular imaging in particu-lar, Allied Diagnostics regularly give practical training

courses to visiting clinicians and radiographers.


Easily disinfected one-piece sphygmomanometer cuff

A one-piece-cuff is now available as standard for all Riester sphygmomanometers; the new blad-derless nylon Velcro cuff is reusable over 10 000 times and is washable up to 60°C. Cleaning and disinfection for the one-piece-cuff is also much

easier than standard cuffs as it can be immersed completely into an alcohol disinfection solution between use. Made of latex-free material, it is especially practical for hospital use as it saves time and minimises the risk of contamination. The cuff itself is made of soft material that gives a comfortable feeling on the skin and comes with a 50 cm length of tubing. It is available as a 1-tube or 2-tube version, with sizes to fit children, adults and obese patients and has been tested according to ISO E01 Standards. The Riester reusable one-piece-cuff thus makes checking blood pressure a safer and more efficient proc-ess, not only providing patient comfort but also easy disinfection.

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Flexible ceiling-mounted supply units

Whenever a clinic sets up a new operating room or intensive care unit, the equipment should be able to adapt to all likely future requirements yet remain affordable. These principles are behind the development of Trumpf ’s new TruPort system of ceiling-mounted supply units. The creative design makes it easy to remodel, con-vert and expand workstations even after their installation. As a result, hospital staff can make adjustments at any time according to safety, ergonomic or budget requirements. TheTruPort support heads can be set up individually on all four sides and over their entire length; the front and rear are no longer fixed as in previous ceil-ing-mounted supply units. A spring-aided clip system means that trained personnel can also flexibly integrate, remove or vary the arrange-ment of gas, power and data supply modules by means of a simple tool. Components such as rotatable LED lights, cable remote controls for anesthetics or drawers without handles can be attached at the desired, optimum place on a multifunctional rail using the simple click mechanism. An electro-pneumatic brake system together with a friction brake facilitates posi-tioning of the ceiling-mounted supply unit and enhances safety during handling. All TruPort models permit 330-degree rotation so users can

easily swivel the supply unit outside the work area if necessary. An optional motorised lift-ing mechanism on the TruPort head facilitates individual positioning of additional equipment, such as anesthesia or respiration devices, and provides for foot and floor clearance.

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Portable heart-lung support system

The world’s most compact and lightweight heart-lung support system — a heart-lung machine no bigger than a suitcase — is a complete thera-peutic solution for patients who need cardiac or pulmonary support in intensive care, cardiol-ogy, cardiac surgery and emergency medicine. Thanks to its specific modes of operation and range of disposables, such as a gas exchanger and the appropriate cannulae, the Cardiohelp system is suitable for all patients who require extracorporeal circulatory support or a reduc-tion in blood CO2 levels. The system has been specially designed for use in the intensive care unit, but is just as easy to use in the operat-ing room or in the cardiac catheter laboratory. With its extracorporeal gas exchange and pump functions the system can supply oxygen to the heart and other organs as well as assist patients with reduced lung function. Characterised by a short preparation time and its user-friendly operation and management, the system can be operated and monitored by nursing staff using a single rotary knob and a touch screen. Without the need for tubing and clamps, the various gas exchangers, featuring integrated VAD (ventricular assist device) pumps, can be docked directly and are available for immedi-ate use. Using two software versions and three different disposables, the Cardiohelp System can be adapted to the specific requirements for cardiopulmonary support and CO2 reduction.

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High precision image-guided radiotherapy and radiosurgery

A radical new approach that expands radio-therapy treatment options for even the most challenging cases has been introduced by Varian Medical Systems. The TrueBeam platform for image-guided radiotherapy and radiosurgery is the first fully-integrated system designed from the ground up to treat a moving target with unprecedented speed and accuracy. The new line of “super” accel-erators is designed to advance the treatment of lung, breast, prostate, head and neck, and other types of cancer. Using a completely re-engineered con-trol system and a multitude of technical innovations to dynamically synchronise imaging, patient positioning, motion man-agement and treatment delivery, the new system allows the development of new and improved approaches for treating cancer and other medical conditions.

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New workflow standards in volumetric echocardiography

The latest release of the ACUSON SC2000 vol-ume imaging ultrasound system supports the needs of cardiography examina-tions and offers a complete 2D and volume echocar-diography approach that provides excellent imaging performance and one-of-

a-kind workflow improvements in conventional and real-time volumetric echocardiography. Featuring an entirely new approach to workflow, the unique eSie Measure workflow acceleration package is the first application in the indus-try to provide semi-automated measurements for routine echo exams. In addition eSieScan workflow protocols are available, which bring higher reproducibility and quality standards to the echocardiography workflow. Customisable according to user or departmental requirements, the protocols dramatically reduce the need for user interaction and the number of key strokes during the imaging process. The system’s work-flow protocols can help sonographers decrease scan time by 10 to 15 minutes per patient.

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Ultrasound cleansing and disinfection systemThe Mides TEE-Care all-in-one system is a fully-automatic all-in-one ultrasound cleans-ing and disinfection system that simultaneously carries out a leakage test, based on the measure-ment of leakage current. The fully automatic operation sequence not only makes the system

extremely practical and safe to handle but also prevents errors and possible probe damage. The high-tech system provides a complete hard copy documentation of the whole process. The touch-screen inter-face is easy to use and provides han-dling and a graphic real-time view of the

cleansing and disinfection process. The system is compatible with all disinfection solutions.

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Medica Hall 10/A39

FDA-approved CT scanner

Recently approved by the FDA, the NeuViz 16 multi-slice CT scanner incorporates the latest integrated detector for optimal signal to noise ratio (SNR) and scanning time. The proprietary technology of dynamic focal spot enables the system to provide a higher spatial resolution during scanning and creates more detailed 3D/MPR images. The product also features the DoseRight Modulation system as well as a pediatric protocol to ensure that the

dose is optimised without any compromise to image quality. One of the main advantages of the CT new system is its embedded software, a speciality of Neusoft Medical and which ena-bles the diagnostic capbilities of the CT to be significantly expanded.

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Replacement CT tubes

Replacement CT tubes from Dunlee are identi-cal to the original tube in fit, form and func-tion; the warranty also matches that of the original equipment producer. Dunlee manu-factures replacements for all major brands including GE, Siemens, Toshiba, Picker, Els-cint, Shimadzu and Philips. The latest Dunlee replacement tube is the Reevo 240G replace-ment CT tube, which is specifically designed as a replacement for use in the GE LightSpeed VCT and Pro 16 CT series systems. Addi-tional products from Dunlee include AKRON replacement tubes designed for use on popular Siemens multi-slice CT scanners.

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Medica Hall 10/A60

MEdiCA PREViEW

31st International Symposiumon Intensive Care and Emergency MedicineBRUSSELS MEETING CENTER, (SQUARE)

Endorsed by:European Society of Intensive Care MedicineSociety of Critical Care MedicineAmerican Thoracic SocietyEuropean Society for Emergency MedicineEuropean Shock SocietyThe Institute of Critical Care MedicineThe Canadian Critical Care SocietyAustralian and New Zealand Intensive Care SocietyInternational Pan Arab Critical Care Medicine SocietyWorld Federation of Societies of Intensiveand Critical Care MedicineInternational Sepsis Forum

Meeting Chairman: JL VincentEmail: [email protected]

Manager: V De VlaeminckEmail: [email protected]

Dept of Intensive Care , Erasme University HospitalRoute de Lennik, 808, B-1070 Brussels, BelgiumPhone 32.2.555.32.15/36.31, Fax 32.2.555.45.55Email: [email protected]

Website: http://www.intensive.org

Deadline for abstract submission: December 15, 2010

CME AccreditationPlenary Sessions, Mini-Symposia, Workshop, Technical Forums, Round Tables, Tutorials, Posters

March 22-25, 2011

ANNONCE 206*86 horizontale 31TH 2011:50193 join us 2006 15/09/10 9:13 Page 1

MEdiCA PREViEW32 – September/October 2010

Ultrasound probe disinfection and testing system

The C-10 Probetester is an automated device that measures electrical leakage in ultrasound probes during the dis-infection cycle. The new system thus provides an efficient way of con-firming that the probe is electrically safe for fur-ther use with a patient

and that there is no damage on the surface which could impair the function of the probe. The device also protects hospital personnel by minimising exposure to disinfection solutions. In addition, the fully automatic operation of the system frees up personnel for other duties.

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Medica Hall 08b/C03

Identification of AKI risk in critically ill patients

A novel bedside blood test, the Triage NGAL test has been devel-oped by Alere for use in critically ill patients on their admittance to the intensive

care unit to help identify which patients are at risk of acute kidney injury (AKI). This is a common and often devastating complication that can affect up to 25% of critically ill patients admitted to the ICU and can lead to increasing length of hospi-tal stay and associated costs, not to mention an increased risk of death. AKI is often detected too late in its clinical progression when a substantial portion of kidney function may already have been lost and the window for initiating treatment to prevent further harm has closed. The new test is based on the detection in plasma of NGAL (neu-trophil gelatinase associated lipocalin) which is a new early marker for acute kidney injury. NGAL levels rise rapidly after renal injury and can thus be used in a variety of clinical situations includ-ing intensive care, emergency medicine and renal transplantation. In a recent study of several hun-dred critically ill patients, plasma NGAL levels measured with the new test system were found to be a statistically significant diagnostic marker for AKI development within the next 48 hours.

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Medica Hall 03/C70

Complete blood pressure controlContinuous blood pressure informa-tion is now avail-able to all medical disciplines where previously it may not have been possible due to cost, complication risk or environ-mental factors. The CNAP Moni-tor 500 offers

continuous non-invasive arterial pressure measurement either via a stand alone-device or connected to existing patient monitor-ing equipment. The new system provides the physician with beat-to-beat systolic, diastolic and mean blood pressure, a high fidelity blood pressure curve as well as the pulse rate. In its default setting, the new monitor presents mul-tiple information on its large anti-reflective display, such as high fidelity blood pressure curves, beat-to-beat blood pressure values, the pulse rate and a trend view of blood pressure and pulse rate. The highly customisable alarm systems can be set to different blood pressure values or the pulse rate.

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Medica Hall 17/D20

ECG monitor

The new CardiMax FX-8322/R monitor from Fukuda Denshi is equipped with a large LCD screen to display clear ECG waveforms. The system can be operated either through the key-board/buttons or via the touch panel keys. Data can be saved to an SD card, a USB memory or sent to a DMS (Data Management System) via either a hard-wired or wireless network. For carrying out stress examinations, it is possible to connect the system to an external monitor so that the examination results can be seen while still making sure that the condition of the patient is satisfactory.

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Medica Hall 09/E67

Contrast Enhanced Spectral Mammography

The process of cancer evolution is often linked to a proliferation of small blood vessels (ang-iogenesis). In the breast, the presence of these small vessels is an indirect clinical indication of breast cancer. The new SenoBright system from GE healthcare uses Contrast Enhanced Spectral Mammography (CESM), in which intravenous injections of standard contrast agents are used to locate the small vessels linked to the cancer. The approach has been shown in clinical trials to identify more can-cers than are detected with current mammog-raphy techniques. The method also shows potential for measuring the extension of the lesion to help to plan surgery and treatment. The technology reduces ambiguity in screen-ing results, enabling physicians to detect and diagnose cancer in dense breast tissue more rapidly and accurately. To generate the enhanced image, the system uses X-rays at multiple energies to create two separate expo-sures, specifically illuminating and highlight-ing areas where there is angiogenesis. The flash used to look for the suspicious regions is of a particular spectrum that highlights the contrast agent in the areas with proliferation of angiogenesis. A special proprietary image combination algorithm enables visualisation of the blood vessel information together with the usual breast tissue structure images side by side. The system is easy to use and operates at a dose level inferior to stringent guidelines for digital mammography. Clinical trials have proven that the use of SenoBright Contrast Enhanced Spectral Mammography has sig-nificantly improved the accuracy of the exam.

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Medica Hall 10/A56

PRodUCt NEWs 33 – September/October 2010

Surgical sealant film reduces air leaks during lung operationsTissuePatchThoracic is an ultra thin adhe-sive film that is resilient and conformable to the tissues, and has improved handling characteristics. Available in sizes suit-able for use in keyhole procedures, such as Video Assisted Thoracic Surgery (VATS), the product has been specifically designed to enable thoracic surgeons to seal internal air leaks during complicated lung surgery cases in which part of the lung is resected, most commonly for tumour removal. Sur-

gical resection lines are usually closed with staples, and the addition of Tis-suePatchThoracic adhesive film over these staple lines provides the surgeon with reassurance that air will not leak through the tissue and between the staples. Literature data suggest that 70% of lung surgeries result in air leaks and, of these, 15% can be prolonged and problematic. If the surgeon can reduce the number and duration of air leaks, patients can have surgical drains removed more quickly, and so suffer fewer complications and be discharged from hospital more quickly. The film functions by bonding to proteins on the surface of internal organs and tissues, enhancing traditional suture or staple line closure and supporting healing tissues. The product requires no advance preparation and is easy to apply to even complex tissue surfaces.

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Vessel closure deviceAs the only vessel closure device approved in Europe for the closure of large femoral artery access sites, the Prostar XL system has been shown to improve patient recov-ery from abdominal aortic aneurysm (AAA) and tho-racic aortic aneurysm (TAA)

repair and valve replacement. The device has been granted the CE mark for use following minimally invasive procedures that leave large holes of up to 24F in the femoral artery in the upper thigh. Less invasive procedures in the cardiac catheterisation lab, such as those used to repair abdominal aortic aneurysms or thoracic aortic aneurysms, generally involve delivery of therapeutic devices using relatively large sheaths in the access site in the patient’s leg, leaving behind a larger hole that needs to be closed.

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ECG processing and storageThe IMPAX HeartStation solution for ECG analysis is Agfa’s comprehensive data manage-ment solution for automating the processing and storage of electrocardiograms. The solu-tion offers an extensive range of ECG-related clinical tasks and is now available across Europe. The new system allows specialists to digitally review and archive 15-lead ECG studies. Compared to more commonly found 12-lead ECG equipment, 15-lead ECG pro-vides more data for detecting heart attacks in the right and posterior ventricle walls.

IMPAX HeartStation’s innovative features analyse and prioritise 12- and 15-lead ECG exams as they come into the system and alert care providers if an ECG indicates that a patient is experiencing a critical condition.

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PRO2XY

Your source of on-site oxygen :

• turnkey system

• economically interesting

• complying with ISO 10083 Standard

• guaranteed flow and rate of oxygen

• output pressure 5 or 12 bar

On-site medicinal oxygen generator

www.mils.fr [email protected]

Hall 17 Stand A 23 C


Solid state detector for AEC-equipped X-ray systemsThe T-20 Translucent Detector is designed specifically for measure-ments on Rad/Fluoro-scopic systems when it is crucial that the detector itself does not affect the system output or disturb the automatic exposure control (AEC) system. Up till now, measurements like this were often per-formed with an ion cham-ber because of the adverse effects caused by the density, size and design

of solid state detectors when placed in the beam. The T-20 provides a unique solid state solution with its “almost not there” design char-acteristics; the size is small enough to not adversely affect the X-ray system or AEC. The unique design has the detector separated from the cable attachment by a carbon fibre rod, long enough to do measure-ments on a digital detector/image intensifier as large as 45 x 45 cm yet “invisible” because of the carbon fibre material. To ensure that a detec-tor this small is positioned correctly and securely, carbon fibre “wings” are added to the sides of the detector. These “wings” make sure that the detector surface lies flat against the incident beam while having no effect on the system output, and not disturbing the X-ray beam.

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PRodUCt NEWs34 – September/October 2010

Endovascular treatment of abdominal aortic aneurysms

The Zenith low profile AAA endovascular graft from Cook Medical has just received CE approval, and the advanced technology device will now be available initially at 20 European centres where the company will conduct a clini-cal registry intended to capture patient outcome data for later publication. At 16 French, the device is significantly smaller than most com-monly used EVAR delivery systems, which typi-cally measure 20-24 French. This reduction in the diameter of the delivery device opens EVAR to a wider range of patients. The newly engineered stent-graft is based on Cook’s ARC Technology, which combines a series of barbs that engage the vessel wall to provide active fixation, radial force from self-expanding z-stents for stability and optimal graft-to-vessel apposition. In addition the device has a long main body with columnar strength that mimics the aorta’s natural anatomy. The new system is good news for surgeons treat-ing patients with difficult or tortuous arterial access who might otherwise have been ineligi-ble for EVAR. This patient group includes many women and smaller-bodied adults whose more narrow and angulated arteries can impede the accurate positioning of an endovascular graft using the currently available larger-diameter delivery systems.

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Ablation catheter approved

European CE Mark approval has been granted to the Therapy Cool Flex ablation catheter from St Jude Medical. Ablation catheters are used to help treat cardiac arrhythmias, i.e. irregular heart rhythms often caused by abnormal electrical sig-nals. The catheter tube delivers radiofrequency (RF) energy to specific areas of cardiac tissue in

order to create lesions, or tiny scars, that interrupt such abnormal electrical signals. With its fully irrigated and flexible tip the new system allows for more successful procedures and reduced com-plications. The new features provided by the cath-eter allow greater flexibility in movement which can improve the targeting of the area of heart tissue causing problems. They also reduce some of the risk factors such as blood coagulation, charring and more serious complications.

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High intensity focussed ultrasound (HIFU) system

Combining proprietary multi-focal length trans-ducer technology in a custom, transrectal imaging and therapy probe, the Sonablate 500 system high intensity focussed ultrasound (HIFU) system uses ultrasound imaging for treatment planning and monitoring. Both Split-Beam HIFU and Sin-gle-Beam HIFU are available for targeted, non-invasive tissue treatment. The proprietary HIFU Simu-plan therapy treatment software allows the surgeon to select multiple treatment zones as nec-essary for a clinician-directed, computer-control-led treatment. A new colour-coded overlay plan-ning system with enhanced prostate visualisation simplifies the process. The active cooling and circulation system, along with the RIM (reflec-tivity index measurement) and RDM (rectal wall distance measurement) systems provide for treat-ment safety. A slim, space-saving cabinet with a reduced footprint has been matched with a 17-inch, true colour, flat panel monitor with 1280 x 1024 high resolution capability for ease of use and volumetric prostate visualisation.

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CALENdAR oF EVENtsNovember 16-18, 2010Doppler-Echocardiography in Intensive Care MedicineBrussels, BelgiumTel. +32 2 555 36 31Fax +32 2 555 45 55e-mail:[email protected] www.intensive.org

November 17-20, 2010MEDICADüsseldorf, Germanye-mail: [email protected]

Nov 28 – Dec 3, 2010RSNA 2010Chicago, IL, USATel. +1 630 571 2670www.rsna.org

Nov 30 - Dec 2, 201016th Postgraduate Refresher Course: “Cardiovascular and Respiratory Physiology Applied to Intensive Care Medicine”Brussels, BelgiumTel. +32 2 555 36 31Fax +32 2 555 45 55 e-mail: [email protected]

Nov 30 – Dec 2, 2010Clinical Excellence AsiaMarina Bay Sands, Singaporewww.iirme.com/clinicalasia

December 5-8, 2010Respiratory MonitoringRome, ItalyTel. +32 2 555 36 31Fax +32 2 555 45 55e-mail: [email protected] www.intensive.org

December 13-15, 2010 Medifest India 2010New Delhi, IndiaTel. +91 11 30580444e-mail: [email protected]

January 19-21, 2011The International Medical Distributor Meeting (IMDM): Cardiovascular Budapest, HungaryTel: +41 22 533 0948www.internationalmedicaldistribu-tormeeting.org

January 24-27, 2011Arab Health 2011Dubai, UAETel. +971 4 336 5161 e-mail: [email protected]

February 24-27, 2011International Conference on Prehyper-tension & Cardio Metabolic SyndromeVienna, AustriaTel. +41 22 5330948 Fax +41 22 5802953e-mail: [email protected]

March 3-7, 2011ECR 2011Vienna, AustriaTel. +43 1 533 40 64 - 0Fax +43 1 533 40 64 - 448e-mail: [email protected] http://myESR.org

March 17-20, 2011KIMES 2011Coex, Seoul, KoreaTel. +82 2 551 0102Fax +82 2 551 0103e-mail: [email protected]

March 22-25, 201131st International Symposium on Intensive Care and Emergency Medicine (ISICEM)Brussels, BelgiumTel. +32 2 555 36 31Fax +32 2 555 45 55e-mail: [email protected]

March 29-31, 201114th SE-Asian Healthcare Show & ConferencesKuala Lumpur, MalaysiaTel +603 79 54 65 88 Fax +603 79 54 23 52 e-mail: [email protected]

April 6-8, 2011Med-e-Tel 2011Luxembourg, LuxembourgTel. +32 2 269 84 56Fax +32 2 269 79 53e-mail: [email protected]

May 10-13, 2011World of Health IT 2011Budapest, Hungarye-mail: [email protected]

May 24-27, 2011Hospitalar 2011São Paulo, Brazilwww.hospitalar.com/ingles/

June 7-9, 2011Medifest South AfricaCape Town, South Africawww.vantagemedifest.com

June 11-14, 2011 Euroanaesthesia 2011Amsterdam, The NetherlandsTel. +32 2 743 3290www.euroanesthesia.org

June 22 - 25, 2011CARS 2011 - Computer Assisted Radiology and SurgeryBerlin, GermanyTel: +49-7742-922 434e-mail: [email protected]

dates and descriptions of future events have been obtained from usually reliable official industrial sources. iHE cannot be held

responsible for errors, changes or cancellations.

For more events see www.ihe-online.com/events/

DUBAI INTERNATIONAL EXHIBITION CENTRE DUBAI, UAE

24-27 JANUARY 2011

GE Healthcare

© 2009 General Electric Company.

Today, thanks to breakthrough ASiR™* technologyfrom GE, clinicians have the freedom to lower patientdose dramatically without compromising image quality.ASiR delivers the high-quality images they need todiagnose with confidence — and only GE has it.Learn more at gehealthcare.com/lowdoseCT

A healthy doseof freedom.

*Adaptive Statistical Iterative Reconstruction, a proprietary dose-reducingapproach that subtracts noise without degrading anatomical integrity.

GE imagination at work

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ihe sept oct2010

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