Percutaneous coronary intervention in the UK:recommendations for good practice 2015Adrian P Banning,1 Andreas Baumbach,2 Dan Blackman,3 Nick Curzen,4

Sen Devadathan,5 Douglas Fraser,6 Peter Ludman,7 Micheal Norell,8 Dougie Muir,9

James Nolan,10 Simon Redwood,11 On behalf of the British CardiovascularIntervention society

▸ Additional material ispublished online only. To viewplease visit the journal online(http://dx.doi.org/10.1136/heartjnl-2015-307821)

For numbered affiliations seeend of article.

Correspondence toProfessor Adrian Banning,Oxford Heart Centre, OxfordUniversity Hospitals, HeadleyWay, Oxford OX39DU, UK;adrian.banning@ouh.nhs.uk

Received 16 March 2015Revised 14 April 2015Accepted 15 April 2015

To cite: Banning AP,Baumbach A, Blackman D,et al. Heart 2015;101:1–13.

ABSTRACTOver the last 35 years, there has been dramatic progressin the technology and applicability of percutaneoustechniques to treat obstructive coronary heart disease.Percutaneous coronary intervention (PCI) has aconsiderable evidence base and it is firmly established asthe most common procedure used in the invasivetreatment of patients with coronary heart disease in theUK. This set of guidelines aims to address specificallyissues relating to PCI and not the growing subspecialtyof structural heart disease intervention. It is not intendedto provide a review of the entire evidence base forcoronary intervention. The evidence base relating to PCIis extensively reviewed in international guidelines andthe British Cardiovascular Intervention society endorsesthese guidelines and their updates. The guidelinespresented here focus on issues pertinent to practicewithin the UK and set out a recommended template toensure optimal delivery of patient care.

INTRODUCTIONOver the last 35 years, there has been dramatic pro-gress in the technology and applicability of percu-taneous techniques to treat obstructive coronaryheart disease (CHD). Percutaneous coronary inter-vention (PCI) has a considerable evidence base andit is firmly established as the most common proced-ure used in the invasive treatment of patients withCHD in the UK.In a field where technology continues to

develop rapidly, it is essential that centres under-taking PCI are appropriately equipped, for staffto be competent and for case selection to bematched to the skill of the operators. This is thefourth set of guidelines produced by the BritishCardiovascular Intervention Society (BCIS) andthe British Cardiovascular Society (BCS) and itreplaces the Guideline published in 2005.Considerable developments have occurred duringthe last 10 years including the widespread appli-cation of emergency primary PCI (PPCI) fortreatment of patients with ST segment elevationmyocardial infarction (STEMI). Providing com-prehensive data remains an essential requirementboth for the centres and operators performingPCI. The BCIS audit of adult interventional pro-cedures, run in collaboration with the NationalInstitute for Cardiovascular Outcomes Research(NICOR) allows each patient’s outcome to betracked through his or her individual cardiacjourney from birth until death, in turn enabling

the UK’s national data to be analysed, presentedand reviewed. Within the last year individual PCIoperator outcomes of PCI procedures have beenpublished in the public domain.There has been a slowing in the previously expo-

nential increase in rate of PCI in the UK within thelast few years. The need for emergency cardiacsurgery following failed angioplasty remains, butthis is now very infrequent. A large proportion ofPCI is undertaken without on-site surgery and thelinkage of these sites within Cardiac Networksremains fundamental to the delivery of optimalpatient care, particularly when considering surgicalrevascularisation options. A common standard isapplied in assessing a site’s suitability for the per-formance of PCI and this is independent of theprovision of on-site surgery. Sites performing emer-gency PPCI have specific requirements whichexceed those of sites performing only selectedelective and urgent cases.This set of guidelines aims to address specifically

issues relating to PCI and not the growing subspe-cialty of structural heart disease intervention. It isnot intended to provide a review of the entireevidence base for coronary intervention. Theevidence base relating to PCI is extensivelyreviewed in international guidelines and BCISendorses the guidelines issued by the EuropeanSociety of Cardiology (ESC) and the AmericanHeart Association (AHA) and their updates.1 2

The guidelines presented here focus on issues per-tinent to practice within the UK and set out arecommended template to ensure optimal deliveryof patient care.

STANDARDSInstitutional facilitiesA centre performing PCI requires at least onecardiac catheterisation laboratory. As there will beinevitable equipment failures—a second catheterisa-tion laboratory is ideal to provide an uninterruptedservice. In the absence of a functional secondcardiac catheterisation laboratory—a non-cardiacradiological facility used for general radiologybackup or a high resolution portable fluoroscopyunit with a small image intensifier is considered theminimum requirement.Contemporary archiving in a Digital Imaging and

Communications in Medicine compatible format ismandatory and it should be stored and accessiblefor a minimum of 8 years. Angiograms should bestored securely on a database allowing ready access

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during emergencies. PCI centres remote from surgical centresshould have facilities for real-time image transfer to facilitatediscussion and advice about individual patients’ cases. Ideallyclinical networks should invest in secure information technologythat allows any neighbouring site in the region to view archivedpatient data as this would facilitate optimal emergency care.

Physiological measurements including accurate pressurerecording and display of the waveforms on multiple simultan-eous channels along with the facility to display and record arange of ECG lead configurations are required. Patients whohave received sedation and/or analgesia should have their heartrate and oxygen saturation monitored continuously throughoutthe procedure.

Full resuscitation facilities including a defibrillator, intra-aortic balloon counter-pulsation and an anaesthetic machineshould be readily available in all catheterisation laboratoriesundertaking PCI. Facilities for monitoring anticoagulation (eg,activated clotting time) and blood gas analysis should be avail-able within the catheterisation laboratory complex. A widerange of disposable angioplasty equipment including guidecatheters, guide wires, balloons and stents must be available atall times and an appropriate method of inventory and stockcontrol is mandatory. Availability of covered stents to treatperforation, pericardiocentesis sets to treat tamponade and anaccessible echocardiography machine is mandatory. Recenttechnological advances have resulted in the availability ofmany additional tools including intravascular ultrasound(IVUS), optical coherence tomography (OCT), flow and pres-sure wires and equipment for laser and/or rotational atherect-omy. The role of pressure wire in functional evaluation ofcoronary lesions is well established. This technology togetherwith IVUS forms an essential part of interventional diagnosticprocedures and should be available in catheter laboratoriesperforming coronary interventions.

Radiation protectionAll catheter lab staff should be aware of the latest guidelines onradiation protection. A representative of the radiation protectionofficer—usually a radiographer—should ensure that all staffcomply with appropriate monitoring and that lead screens,aprons, glasses and other methods of radiation shielding areavailable and used appropriately. Monitoring of individual doseexposure is mandatory along with feedback of the cumulativedose.

Radiation risks from cardiac procedures should be dis-cussed with the patient as part of the pre procedure consentprocess.3 It is good practice to include the hazards associatedwith radiation exposure on the consent form for PCIs.Almost all the current catheter lab radiography sources areequipped with methods to calculate and record peak skindose and dose area product. Recording of the patient’s doseexposure is mandatory and measures should be in place torecognise patients requiring multiple high dose exposures (eg,computed tomography pulmonary angiogram (CTPA) fol-lowed by PCI). The radiographer should notify the operatorwhere radiation exposure is above the notification threshold(2000 mGy for first notification and subsequent notificationsat every 500 mGy increments3). The patient should be noti-fied if the peak skin dose exceeds 3000 mGy in order tohighlight awareness of potential physical consequences. Manyinstitutions have developed skin dose cards to notify thepatient of the high dose exposure, which also details thewarning symptoms and contact details for further advice.4

Key points: institutional facilities

▸ Two cardiac dedicated catheter laboratories are the minimalrequirement for a PCI service undertaking emergency cases.

▸ Digital Imaging and Communications in Medicine archivingof images.

▸ Physiological assessment facilities in all interventionallaboratories.

▸ Radiation protection mandatory.

Institutional volumeAlthough PCI could be considered as a routine procedure, itrequires an experienced multidisciplinary team that can providehigh quality care throughout the hospital stay. There has beenextensive debate about what should be regarded as theminimum number of annual cases required for both institutionsand individuals to maintain optimal performance. In the guide-lines published in 2000, 200 procedures per annum was set asthe standard for institutions,5 but since 2005 a minimum of 400procedures per annum has been regarded as a minimum.6

These guidelines endorse and maintain the minimum centrevolume of >400 procedures per annum. Recent NICOR dataconfirms the safety of these recommendations in current UKpractice but BCIS recognises that this recommendation willrequire review with continued evolution of PCI techniques.

In 2013, 2 out of 98 National Health Service (NHS) unitsand 18/19 private units in the UK were undertaking less than200 procedures per annum. Twenty-two out of 98 were per-forming less than 400 procedures per annum. Centres perform-ing fewer than 200 procedures per annum for threeconsecutive years have been named and contacted by BCIS.BCIS continues to recommend the same facilities and standardsfor both NHS and private hospitals with a minimum recom-mended volume of 400 interventional cases per year. In thefuture, every centre performing <400 cases per year will becontacted by BCIS who will notify NHS England and theCommissioners of sites whose practice is outside the recom-mended volume guideline.

Interventional diagnostic proceduresThere are considerable data supporting the role of physiologicalassessment of stenosis using pressure wire prior to interven-tion.7–10 There is also data on the use of cross-sectional imagingwith IVUS or OCT to measure lumen area and guide PCI.11 Useof pressure wire and use of IVUS/OCT are regarded as interven-tional diagnostic procedures by BCIS which endorses the use ofthese techniques in appropriate cases. Interventional diagnosticinterventional cases should be performed in PCI centres withfull interventional cardiology capability and by accredited inter-ventional cardiologists able to treat any complications whichmight occur, for example, coronary dissection.

Interventional team numbersThe minimum recommended number of trained interventionalcardiologists within a PCI centre is three. Some centres haveused joint cover arrangements with neighbouring centres tofacilitate the initiation of the service. This arrangement shouldbe regarded as temporary and there is an expectation that athird local permanent colleague will be appointed within2 years.

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PPCI for STEMI—PPCISpecific standards required for centres that provide emergencyPPCI for patients with STEMI have been developed by theClinical Reference Groups. It is expected that Trusts shouldcomply with all recommendations.

These BCIS guidelines recommend that patients undergoingPPCI should be treated in 24/7 PCI centres treating more than300 PPCI patients per annum. In view of geographical isolation,this case volume may be impractical in some isolated areas butBCIS suggests that for the UK, PPCI centres should all performan absolute minimum of 100 PPCI procedures per annum.Centres performing <300 PPCIs/annum should consider annu-ally whether a Network approach which rationalises the numberof adjacent PPCI centres would be a more appropriate model ofcare.

A PPCI centre should have two or more cardiac catheterlaboratories and will require a larger catheter lab team to staff amanageable rota. PCI operators should regard their contributionto a PPCI rota as a fundamental part of their job plan. It isrecognised that this will necessitate cooperation between trustswith regards to cross-charging, back-filling of duties at the basehospital and compensatory rest.

Ultimately a sustainable PPCI rota for ConsultantCardiologists should comprise a minimum of 6 InterventionalCardiologists and ideally 10.

Key points: institutional volume

▸ Minimum centre volume is 400 cases/year.▸ Minimum of three interventional cardiologists per centre.▸ PPCI centres should have at least two catheter laboratories

and 24/7 provision of service for STEMI.▸ PPCI centres should perform an absolute minimum of 100

STEMI/PPCI cases/year.

Surgical cover standardsBCIS fully supports the provision of PCI in appropriatelyselected patients in centres without on-site cardiac surgery, pro-vided standard centre and operator requirements as described inthis document are satisfied.

PCI without on-site cardiothoracic surgical cover is com-monly performed in the UK. Emergency transfer for surgicalintervention has come down significantly since the advent ofintracoronary stents. While, 2.6% of patients undergoing PCIrequired emergency coronary artery bypass grafting (CABG) in1991,6 this has come down to 1.1% by 2007 and the latestBCIS audit data showed 0.05% patients required emergencytransfer for surgical revascularisation in 2012.12 The eventualoutcome in these patients would have been different withoutemergency surgical intervention.

Therefore, PCI centres without on-site surgical cover shouldhave a viable protocol for emergency transfer to the nearest sur-gical centre. The protocol must be agreed by all stakeholders,including the relevant parties in the non-surgical centre and thesurgical centre with which it works, local networks, commis-sioners, and the ambulance service. The protocol will need toaddress the training and availability of staff to accompany thepatient, including an anaesthetist when required. Emergencytransfer of patients should occur within a maximum of 1 h,with the ability to start cardiopulmonary bypass within 2 h of

the call for surgical intervention.13 Necessary equipment shouldalso be considered, including a transportable intra-aortic ballooncounter-pulsation pump (IABP). BCIS recommends that thefeasibility of ambulance transfer of the IABP be tested toconfirm it can be achieved within the required 120 min timeline.A good working relationship with the cardiac surgical team inthe surgical centre is essential for all non-surgical PCI centres. Itis considered good practice to undertake a virtual run (withoutthe requirement for actual ‘blue light’ driving) of a catheter labto surgical centre transfer with IABP annually.

Off-site surgeryIn the UK the number and proportion of centres performingPCI without on-site surgery continues to increase year-on-year,and is now in the majority. In 2013 there were 69 non-surgicalPCI centres and 48 surgical centres. In all 37 008 PCI proce-dures were undertaken in units without on-site cardiac surgery,representing 40% of total UK activity. Within the current AHA/American College of Cardiology PCI guidelines, published in2011, there is a Class IIa recommendation for PPCI in hospitalswithout on-site surgery, whereas the guidelines give only ClassIIb support for non-PPCI, stating that “Elective PCI might beconsidered in hospitals without on-site cardiac surgery, providedthat appropriate planning for programme development has beenaccomplished and rigorous clinical and angiographic criteria areused for proper patient selection”.14 In fact, since these guide-lines were written, two major multicentre randomised con-trolled trials have been reported, and both support the safety ofnon-PPCI in hospitals without on-site cardiac surgery. In theCPORT-E trial, 18 867 patients were randomised 3:1 toundergo PCI in centres with off-site surgery versus on-sitesurgery.15 There was no difference in the primary safety endpoint of 6-week mortality (0.9% vs 1.0%), nor in the incidenceof emergency CABG (0.1% vs 0.2%). Mortality in thosepatients who underwent emergency surgery was also no differ-ent between the non-surgical (2/13, 15.4%) and surgical (2/10,20%) centres. However, procedural success was lower in non-surgical centres (90.7% vs 91.4%, p=0.007), and target vesselrevascularisation was higher after 12 months (6.5% vs 5.4%,p=0.01). More recently the MASS COM trial randomised 3691patients undergoing non-PPCI 3:1 to be treated in non-surgicalor surgical centres.16 Again there was no difference in theprimary safety end point of 30-day major adverse cardiac events(MACE) (9.2% vs 9.1%), nor in the need for emergency CABG(0.3% vs 0.1%). In contrast to Cardiovascular Patient OutcomesResearch Team-E trial (CPORT-E) there was also no differencein procedural success or in 12-month outcomes including targetvessel revascularisation (TVR). It is difficult to translate the find-ings of these studies directly to UK practice given the substantialdifferences in the organisation of services, in particular very lowvolume non-surgical centres (117/year in MASS COM, 150/yearin CPORT-E) but staffed, at least in CPORT-E, by operators allof whom were practising in surgical centres as well as non-surgical centres, and whose individual PCI volumes were identi-cal to those of the surgical centre interventionists. Nonetheless,they provide solid support for non-emergency PCI in centreswithout on-site surgery. Furthermore, a very large meta-analysisincluding 914 288 patients undergoing non-PPCI in a numberof European as well as North American centres also showed nodifference in crude rates of inhospital mortality or emergencyCABG between patients treated in hospitals with off-site surgeryversus on-site surgery, although after adjustment for publicationbias, the risk of inhospital death was reported to be higher bythe investigators (OR 1.25, p=0.04).17

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Key points: surgical cover

▸ Surgical cover arrangements must be annually confirmedand carefully documented.

▸ A maximum delay of 120 min from call to institution ofcardiopulmonary bypass is the required standard.

▸ Annual virtual practice runs with IABP in situ arerecommended practice.

Staff standardsNon-medical Cath Lab staff numbers and rolesThe number of non-medical trained staff involved in a PCI pro-cedure will depend on skill mix, complexity of the procedureand the number of medical staff involved. BCIS recognises thefundamental requirement of effective teamwork in optimisingpatient outcome and the multidisciplinary team is representedwithin BCIS by the Allied Professionals Working Group.

In most circumstances and in the absence of multiskilled prac-titioners, it is recommended that there is a minimum of twonurses per cath lab and one floater (one nurse at least band 5and above) per shift for PCI procedures. In addition, one radi-ographer and one physiologist per lab (usually band 6 andabove) would be considered normal practice. For units withmore than one catheter lab, a separate additional coordinatorshould be considered (band 6 and above). Procedural roles aresuggested below (table 1).

All staff should have a period of supervision and fulfil acompetency-based training scheme within their hospital. Thereare currently no national competency guidelines for PCI specif-ically but documentation of completion of specified local train-ing should be accessible. An Advanced Life Support certificateshould be held by all senior members of the Cath Lab team. Allother members of the team should hold a minimum of an inter-mediate life supoort (ILS) certificate and all be versed in emer-gencies within the Cath Lab. All members of the Cath Lab teamshould be familiar with the local rules and guidelines for radi-ation protection.

Patient care and consentPatient preparation, informed consent and ward checklistsshould be performed as part of local standard operating policies.

Attention should also be paid to issues which may affect thepatient’s ability to lie comfortably during the case.

ConsentThe General Medical Council and good clinical practicedemands that patients are fully involved in the decisions abouttheir care. Consequently an operator should be satisfied that thepatient has been fully informed about the benefits and risks ofany interventional procedure. Formal signing of the consentform may be delegated to a suitably trained and qualifiedperson only if they have sufficient knowledge of the proposedprocedure, and understand the risks involved. Patients must befully involved in the decisions about their care including detailsof the procedure, benefits, procedural risks and likelihood ofsuccess. Ample time should be allocated to allow the patient tounderstand and discuss this information. All potential seriousadverse outcomes must be explained including the possibility ofdeath, acute myocardial infarction (MI), stroke, the requirementfor emergency cardiac surgery and complications of vascularaccess. The likelihood of such events should be drawn fromlocal and/or national statistics and will vary depending onthe clinical scenario. The website http://www.gmc-uk.org/guidance/ethical_guidance/consent_guidance_index.asp providesthe Gemeral Medical Council (GMC) guidance ‘Consent:patients and doctors making decisions together’.

Written consent is advised for all PCI procedures except in anemergency (1) when verbal consent may be taken together withfull documentation in the case notes or when (2) it is either notpossible to find out the patient’s wishes or the patient lacks thecapacity to give consent. Therefore, even in the setting of PPCI,some form of either written consent or postprocedural writtenrecord of consent is recommended.

A record of the consent form should be kept in the notes andgiven to the patient.

WHO checklistIn addition to ward-based checklists, the National PatientSafety Agency has asked all hospitals in England and Walesto implement a five-stage checklist for all interventional proce-dures based on the WHO safe surgery checklist (http://www.nrls.npsa.nhs.uk/resources/collections/10-for-2010/five-steps-to-safer-surgery/?entryid45=92901). Versions appropriate forcatheter lab use include local adaptations, the interventionalradiology checklist (approved by the National Patient SafetyAgency) and a version endorsed by the BCS.

Table 1 Procedural roles of non-medical catheter lab staff

Procedural roles Nurse Radiographer Physiologist Multiskilled practitioner

Checklist/checking into lab X X X XLead on safe surgery X X X XScrub X XCirculate X XMonitor haemodynamics X X XRadiation protection X X X XSedation/intravenous administration X XCannulation X X XAccess site closure X XInfection control X X X XDocumentation X X X XHandover X XLab preparation/cleaning X X X X

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The five stages are:1. Team brief: All members of the team meet before the start

of the list to discuss the requirements of the day’s list. Safetyissues such as patient allergies and comorbidities are dis-cussed as well as potential procedural difficulties. Equipmentthat may be needed is discussed.

2. Sign in: On receipt of each patient into the cath lab, checkidentification, consent, allergies, pregnancy disclaimer (female11–55 years), renal function, local preprocedure checklist.May be performed by a nurse, radiographer or physiologist.

3. Time out: Before start of each procedure (can be performed afterdraping, but before local anaesthetic) with all team memberstaking part including the operator. Involves further check of‘right patient/right procedure/right route’, consent, allergies andsafety for the team—including lead aprons and doors locked.

4. Sign Out: At the end of the procedure two practitionersensure the procedure has been documented fully anddetailed handover given including any recovery issues.Address safety issues including sharps counted, swabscounted, and identify any equipment problems/stock issues.

5. Debrief: At the end of the list, a discussion to identify goodand learning points, answer questions from team members,promote learning and development of the team and discussany incidents and identify prevention strategies.

Analgesia/sedationThe majority of PCI procedures can be safely performedwithout any sedation or under conscious sedation, administeredwithout the need for an anaesthetist. This requires the patient tobe responsive to verbal and tactile stimuli throughout the pro-cedure. Each Catheter Lab should have a conscious sedationpolicy and competencies which should be achieved and signedoff before any nurse/practitioner gives conscious sedation.Carbon dioxide levels may rise under conscious sedation, par-ticularly when procedures are prolonged and supplementaryoxygen is given in patients with lung disease or sleep apnoea. Inthese clinical situations, capnography and/or anaesthetic supportshould be considered.

Postprocedural careAfter completion of the PCI procedure the patient is transferred toeither a ward or recovery area. Full details of the procedure,

details of the drugs administered during the procedure, andrecommendations for drug therapy thereafter, together with com-plete procedural documentation should be handed over to thereceiving area staff. Subsequent nursing care should include obser-vation of the point of vascular access, and haemodynamic andECG monitoring. A suggested scheme is included below (table 2).

Before discharge from hospital the patient with PCI should begiven written instructions relating to possible vascular and othercomplications and advice on activity during the recovery periodincluding driving, etc. Arrangements should include a schedulefor return to work and proposed follow-up along with drugtherapy instructions and planned interactions with formalcardiac rehabilitation programmes. Patient advice cards whichoutline the prescribed dual antiplatelet regime and a contacttelephone number are valuable.

Routine measurement of biomarker/cardiac enzymes after PCIIn patients with acute coronary syndrome (ACS), biomarker ele-vation before the PCI procedure occurs regularly. Consequentlyinterpretation of elevated biomarkers troponin, creatinine kinasemyocardial band (CKMB) post procedure is difficult and meas-urement in ACS patients is not recommended. However, inpatients with stable angina undergoing elective PCI measure-ment of biomarkers at an appropriate interval (4–6 h whentroponin is being measured) after the procedure is valuable andthis is considered to be best clinical practice.

Key points: staff standards/patient care and consent

▸ Minimum staffing levels: two nurses per catheter procedure.▸ Operators should be satisfied that the patient has been fully

informed about the benefits and risks of any interventionalprocedure. This must be confirmed with a written consentform or in the notes.

▸ The WHO checklist or a local equivalent is mandatory.

OperatorsA successful interventional cardiologist requires a combinationof manual dexterity and clinical judgement. Appropriate

Table 2 Postprocedural care, monitoring and observations

RadialSuccessful (without complication) usingfemoral access with device closure

Successful (without complication) usingfemoral access—manual haemostasis

Electiveangiography

Observations/access site check every 15–30 minfor 1st h. Mobilise immediately if no sedation.Discharge after 2 h

Observations/access site check every 15–30 minfor 1st h. Mobilise after 30 min. Discharged min2–3 h

Observations/access site check every 15–30 minfor 1st h. Supine 1 h, sitting 2 h; mobilise 3 h.Discharge min 3–4 h

Day case PCI No ECG monitoring unless stated. Single12-lead ECG post procedure. Observations/access site check every 15–30 min for 1st h,then repeated at 2 h. Mobilise when sedationworn off. Discharged at minimum 4 h

No ECG monitoring unless stated. Single 12-leadECG. Observations/access site check every 15–30 min for 1st h, then repeated at 2 h. Mobilise>60 min and after sedation worn off. Dischargeminimum 4 h

No ECG monitoring unless stated. Single12-lead ECG. Arterial sheath removed ACT<150 s. Observations/access site check every15–30 min pre and post sheath removal.Discharge minimum 5–6 h

Complex PCI—elective

Cardiac monitoring required, post procedure12-lead ECG. Observations and access sitecheck every 15–30 min for as long as required.Mobilise when appropriate. Patients may requireovernight stay, discharged following day

Cardiac monitoring required, post procedure12-lead ECG. Observations and access site checkevery 15–30 min for as long as required. Mobilisewhen appropriate. Patients may require overnightstay, discharged following day

Cardiac monitoring required. 12-lead ECG postprocedure. Arterial sheath removed when ACT<150 s. Observations and access site checkevery 15–30 min for as long as required.Patients may require overnight stay, dischargedfollowing day

Inpatient PCI(urgent NSTEMI/STEMI)

Cardiac monitoring required for STEMI patients and patients with haemodynamic compromise during the procedure. Post procedure 12-lead ECG. It isrecommended that access site and patient checked every 15–30 min for as long as required. Bed rest as per hospital protocol

ACT, activated clotting time; NSTEMI, non-ST segment elevation myocardial infarction; PCI, percutaneous coronary intervention; STEMI, ST segment elevation myocardial infarction.

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emphasis is required on both the practicalities of the techniqueand the procedural numbers but also recognition of the role ofoverall patient assessment and balancing the risk-to-benefitratio. It remains axiomatic that maintenance of the practicalskills necessary for interventional cardiology requires theregular performance of procedures to maintain those skills.Debate is inevitable when setting an arbitrary minimumnumber of procedures required by an individual to maintaincompetence as an independent PCI operator. BCIS defines anindependent PCI operator as an individual who can decide onPCI, plan the strategy and perform the case without consultingany other operator, buddy, mentor or trainer.

Previous guidelines recommend a minimum of 75 PCI pro-cedures per year for independent operators. This did notinclude interventional diagnostic only procedures, which aredefined as the use of Fractional Flow reserve (FFR), IVUS andOCT (and optical frequency domain imaging) when no PCIensues. Although there is insufficient evidence to change theminimum number of total procedures as an appropriate ideal,it is recognised that interventional diagnostic procedures douse a subset of the practical skills needed for PCI.Consequently the recommended combined case volume over2 years is a minimum of 150 cases which can include up to amaximum of 30 interventional diagnostic procedures (includ-ing a mix of elective and non-elective patients).

There is no specified minimum volume for operatorsundertaking PPCI. However it is recognised that thesepatients are among the most challenging patients and thatfamiliarity with teamwork is essential. Consequently opera-tors participating in PPCI cases should undertake an absoluteminimum of >50 elective/emergency cases/annum withinthe emergency PPCI site and a total workload of at least120 PCI cases plus up to 30 interventional diagnosticprocedures.

For Consultants or independent Specialist registrar (SPR)operators who fulfil the guideline of 150 total proceduresover 2 years and who then are absent from practice for lessthan 6 months—no additional training is required. If theperiod of absence exceeds 6 months and is less than 2 years abuddy system should be employed for 20–50 PCI procedures(proportional to the period of absence exceeding 6 months)before the operator becomes fully independent again.Appointment of the buddy should be agreed by the regionalPCI training director.

Operators who have fully trained but have not undertakenany procedures for 2 years or more should perform at least 75PCI procedures with a mentor. This designated mentor shouldformally assess the ability, aptitude and clinical judgement of theoperator.

Cardiologists who have never been trained in PCI and wish tostart PCI should undergo a full formal interventional trainingprogramme.

Individual cardiologists who undertake PCI on multiplesites are responsible for making sure that data from all thesites are sent to NICOR where the data can then be aggre-gated and provided back to them for appraisal and revalid-ation.18 Only one operator can ultimately be responsible for aPCI case although two Consultant Cardiologists may scrubtogether. It is recommended that it is clarified before the initi-ation of the case which consultant is responsible for the caseand the outcome. In cases of debate it is recommended thatthe consultant with the lowest GMC number is recorded (thiswill be the physician registered longest with the GMC) as thedefault operator.

Key points: operator standards

▸ Diagnostic interventional cases are pressure wire/OCT (andoptical frequency domain imaging) or IVUS cases.

▸ Total procedural volume for PCI operators within a 2-yearperiod is a total of 150 cases (can include up to 30diagnostic interventional cases).

▸ Operators participating in PPCI cases should be undertakingan absolute minimum of 50 elective/emergency cases/annumwithin the emergency PPCI site.

The multidisciplinary teamInternational guidelines recommend the utilisation of multidis-ciplinary teams to guide the management of patients with cor-onary artery disease.1 2 Careful discussion about the pros andcons of medical therapy versus revascularisation whether withsurgery or PCI is accepted best practice. The detailed function-ing of such a ‘Heart Team’ varies across the UK as does its com-position, frequency and the type of cases discussed.

In 2013, the BCS, the BCIS and the Society for CardiothoracicSurgery commissioned a joint working group. Its task was toproduce a document with the intention of providing guidance asto the essential components of a Heart Team in terms of how itshould be structured and how it should function.19 The completedocument can be accessed on the websites of all three societies(http://www.bcis.org.uk, http://www.bcs.com and http://www.scts.org). This includes its attendance, scheduling and frequencyas well as the type of cases to be discussed and the minimum datato be presented. Importantly, it also addresses the required man-agerial, administrative and technological support, systems ofdocumentation, feedback and audit, and the degree and timingof patient/carer involvement.

Key areas include:A. Patient and carer involvementThe patient’s presence at the multidisciplinary team (MDT)meeting is usually impracticable. Thus a Clinician, who is famil-iar with the case and is able to represent the patient’s best inter-ests and any declared wishes, should attend. Facilitated by thecoordinator, it should be that clinician’s responsibility to ensurethat the patient is advised of the MDT’s recommendations. Inelective cases, that transfer of information should be undertakenin an outpatient setting which will also present an opportunityto initiate the consenting process.

In cases of equipoise, that is, the evidence for one manage-ment strategy is balanced by that for another, this should be dis-cussed with the patient in order to gauge their own preference.A Clinician of any of the specialties represented at the MDTshould undertake that discussion emphasising the positiveaspects of having more than one treatment available, rather thangiving the impression of clinical indecision.B. Clinical composition and frequencyThe MDT should be chaired by a consultant and comprise aminimum of an interventional cardiologist, a cardiac surgeon andideally a non-interventional cardiologist in order to be quorate.

A clinical individual who is familiar with the case, and is dir-ectly responsible for that patient’s care, should present the datarelated to each patient to be discussed.

MDT meetings should be held at least once per week and atleast 1 h should be allocated.C. Facilities and technical considerationsMDT meetings should be held in a dedicated room that offersprivacy and space for attendees. Patient imaging should be

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displayed on screens offering diagnostic medical quality and bevisible to all attendees. IT support should ensure that imagesfrom remote centres can also be viewed and that where neces-sary two-way voice communication with referral units can beaccomplished during the meeting. It should be available duringthe meeting if required in order to deal rapidly with any tech-nical problems.D. Administration and managerial supportA dedicated MDT coordinator should be present in order to (1)assimilate patient information prior to the MDT meeting, (2)document attendance; (3) record recommendations in each case,and (4) facilitate communication of that decision to all relevantparties.

In cases in which decision-making is not straightforward theessential elements of the discussion should also be recorded.The MDT recommendations, as well as any additional informa-tion where relevant, should be recorded by the coordinator andsigned by the Chair.E. The type and range of cases to be discussedMDT discussion should be considered routine when diagnosticangiography reveals a left main stem stenosis or obstructive mul-tivessel coronary disease, and there is no clinical mandate toproceed immediately to PCI. This is particularly relevant forpatients in which revascularisation is considered high risk orhighly complex including most patients with a chronic totalocclusion. There may be occasions when clinical circumstancesdo not allow time for discussion in a formal MDT setting. Insuch cases ad hoc discussions will take place, the essence andoutcome of which should be documented into the case notes.F. Minimum data discussed and method of presentationClinical data, significant comorbidity and the results of all rele-vant investigations should be made available to the MDT coord-inator prior to the meeting. Patient data should be presented tothe MDT by the clinician familiar with the patient and theirwishes with regards to possible management plans.

A recognised scoring system should be used in evaluating theprocedural risk of either CABG or PCI. In addition theSYNTAX score could also be calculated and used in order toinform the discussion as to the burden of disease.20

G. MDT considerations and functioning in non-surgical centresThe principles of MDT structure and functioning apply to non-surgical cardiology units to the same extent as they do tocardiac surgical centres.

MDT meetings should occur with the same frequency andtiming in non-surgical centres as in surgical units.

In order to ensure that all relevant specialties are represented,clinicians may have to travel between units to attend meetings.If this is considered to be impractical then teleconferencingtechnology is recommended and should be supported by therespective Trusts.H. Timing and integration within job planningMDT meetings should be scheduled during working hours.

Job planning for consultant staff should incorporate theirattendance at MDT meetings.I. Documentation, feedback and audit of outcomesThe outcome of MDT meetings and their recommendations ineach case should be documented and signed by the Chair. Insituations in which the discussion is not straightforward thoseparticular elements that have led to the eventual recommenda-tion should also be documented accurately and signed by theChair. This applies particularly to cases that are judged to be atincreased risk for either CABG or PCI. In addition to recom-mending the need and mode of revascularisation, the MDTshould also indicate the priority in each case.

Units should put in place a system in which cases discussed inan MDTare followed up to ascertain whether the recommenda-tions made were carried out. If there is any aberration then thereasons for this should be discussed and documented in thepatient’s medical records and then rediscussed at the MDT.

Key points: MDT

▸ The MDT should comprise a minimum of an interventionalcardiologist, a cardiac surgeon and a non-interventionalcardiologist in order to be quorate.

▸ A clinical individual who is familiar with the case, and isdirectly responsible for that patient’s care, should presentthe data related to each patient to be discussed.

▸ Job planning for consultant staff should incorporate theirattendance at MDT meetings.

MONITORING STANDARDSAuditAll PCI centres are expected to collect comprehensive andaccurate data that relates to the interventional treatment theyprovide for their patients. This includes information pertainingto the structure of service provision, the appropriateness ofintervention, and the process and outcomes of PCI. The dataare expected to relate to each PCI centre (and not combinationsof centres even if within a single trust).

BCIS provides a clinical data set to allow a national compari-son of results of interventional techniques and comparativeaudit.21 This data set is updated periodically to remain pertinentto current therapeutic strategies. Structural changes to the dataset are made as infrequently as possible to minimise disruptionto the data collection infrastructure, but more frequent updatesare made to the libraries of device names and medications. It isexpected that changes to the BCIS data set can be implementedwithin a notice period of 3 months. Definitions of the variablesare contained within the data set document which takes theform of a spreadsheet and is available on the BCIS website.BCIS oversees and guides the collection and analysis of thesedata which is currently hosted by the NICOR.

It is the responsibility of the Trust/Hospital to provide theappropriate audit and information technology infrastructure toallow clinicians assisted by data managers to collect comprehen-sive and accurate data and to achieve data submission that com-plies with deadlines set by BCIS and NICOR to permit dataanalysis and presentation within the required timescales eachyear.

Each cardiology department should provide the name of adesignated clinician to lead the audit process and ensure thatthe infrastructure is in place. However, the ultimate responsibil-ity for data completeness and accuracy rests with the consultantPCI operator responsible for the PCI procedure.

External data validation is not currently possible. It is there-fore recommended that regular internal validation of case ascer-tainment, data completeness and data accuracy is performed.This is particularly recommended for the date/time fields forpatients treated by PPCI and in the adjudication of high riskclinical features. An annual internal review of cardiogenic shockoutcomes and data entry is especially recommended to ensureconsistency and accuracy.

The BCIS data set requires that information be collected fromsymptom presentation through to discharge from that PCI

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centre. Systems to collate and record events, particularly thosethat occur after a patient leaves the interventional lab requireorganisation and funding. Audit to ensure the completeness andaccuracy of these processes should be performed locally.Outcome data which pertains to catheterisation laboratory dis-charge alone is insufficient.

Recommendations for data collection and submission applyto NHS and private centres.

Institutional audit and clinical governanceBCIS reports the results of an analysis of UK-wide PCI activityon an annual basis. The information is made available on theBCIS website for download. These data can be used by individ-ual PCI centres to assess trends and to benchmark their ownactivity. Internal presentation of a PCI centre’s outcomes andtheir relative performance against the national data is recom-mended on an annual basis.

In addition it is recommended that there is regular review ofeach PCI centre’s practice against established national and inter-national guidelines including National Institute for Health andCare Excellence (NICE), the ESC and AHA as deemed applic-able to UK practice. Regular discussions should include individ-ual case presentations for all unexpected mortality andmorbidity. Additional audit of other complications and, forexample, complex patient or complex lesion subsets are recom-mended. It is expected that Trusts will provide appropriatesupport for this process of clinical governance to allow collationand analysis of these data, ring fenced time for audit meetings,facilities for presentation, and support so that the meeting out-comes can be formally minuted and these minutes archived.

The specifics of the practice of institutional audit vary consid-erably around the country. Examples of good practice includerandom review of individual cases by randomly allocated collea-gues and presentation of the case.

Individual operator outcomesBCIS in collaboration with NICOR, will provide all individualoperators with a detailed breakdown of their own PCI activitythat includes process control charts and risk-adjusted outcomeanalysis. The aim is to provide data for each PCI operator thatcan be used in the process of annual appraisal and revalidation.

Public reportingBCIS, in collaboration with NICOR, will provide a set of ana-lyses at institutional and individual operator levels intended tobe understood by the general public. This process started in2013, with the intention of providing 3-year rolling data in thefuture. Overall numbers of PCI procedures, a split by clinicalsyndrome and risk-adjusted outcomes will be presented in thefirst instance.

Key points: monitoring institutional standards

▸ All PCI centres are expected to collect comprehensive andaccurate data that relate to the interventional treatment theyprovide for their patients.

▸ Regular departmental discussions should include individualcase presentations for all unexpected mortality andmorbidity.

▸ BCIS will provide operators with a detailed breakdown oftheir own PCI activity that includes risk-adjusted outcomeanalysis.

ANNUAL APPRAISAL AND REVALIDATIONThe results of individual operators are likely to be improved bysharing experiences with colleagues. Discussion between opera-tors, both formal and informal, should be part of departmentalmeetings. Maintaining optimal clinical practice in coronaryintervention requires ongoing review of the medical literature.An awareness of the evolution of technology and the availabilityof adjunctive pharmacology is mandatory.

BCIS recommends a minimum of 4 days a year attendingnational and international meetings relating to cardiovascularintervention. A record of Continued Professional Developmentusing the Royal College of Physicians (RCP) website is recom-mended. Demonstration of completion of local statutory man-datory training along with demonstrable participation in qualityimprovement process should be considered standard and be pre-sented within the revalidation portfolio.

BCIS will provide their members who are individual opera-tors with a detailed breakdown of their own PCI activity to beused in the process of annual appraisal and revalidation.

NEW CENTRESThe development of a new PCI site should be agreed by HospitalTrusts with all the relevant stakeholders through a strategicplan developed with the local cardiac network. Stakeholdersinclude the local surgical centre, other nearby PCI centres, localcommissioners of healthcare and specialist commissioners.Recommendations for the structure of a new PCI service areavailable on the BCIS website and should be used as a guide.22

Once a service is prepared for clinical commissioning arequest should be made to the secretary of BCIS by the ChiefExecutive of the Trust. This request should include a statementconfirming that the proposed PCI service will not begin untilBCIS approval for service initiation is obtained. The BCIS peerreview team will comprise two Interventional Cardiologistsfrom outside the region who will arrange a mutually convenienttime for the visit. It is expected that the visit will be arrangedwithin 8 weeks of the request and the BCIS team will expect allof the documentation outlined on the website to be availableprior to the visit.

At the completion of the visit the BCIS representatives willwrite a report and submit it through the Clinical StandardsGroup to BCIS Council. This report is then returned to theTrust Chief Executive with copies to the relevant Network andNHS England.

Follow-up visits are not anticipated subsequent to the agree-ment about the initiation of the service unless special circum-stances apply.

TEACHING AND TRAININGA training programme must ensure that its trainees acquire asound knowledge base of the basic principles that underpin thepractice of interventional cardiology. It is recommended thattraining programmes have a core curriculum that covers at leastthe following important topics:▸ Anatomy and physiology pertaining to the cardiovascular

system.▸ In particular the trainee needs to understand coronary

anatomy including its variations and congenital abnormalities,cardiac haemodynamic function and coronary physiology.

▸ Pathophysiology of cardiovascular disease.▸ Pharmacology principles to provide an understanding of car-

diovascular contrast agents and drugs commonly used forinvasive procedures.

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▸ Principles of haemostasis including indications for and com-plications of vascular closure devices.

▸ Radiology imaging and radiation safety. This should includedesign and operation of X-ray cine angiographic units, basicradiation physics, radiation quality assurance, and an under-standing of the biological risks from radiation exposure so asto minimise radiation exposure to the patient and catheterisa-tion laboratory staff.

▸ Knowledge of lesion assessment with quantitative coronaryangiogram analysis, physiological assessment and intracoron-ary imaging.

▸ The design and performance of interventional devices.▸ Clinical management strategies to include case selection, per-

formance of the procedures, and subsequent management ofthe patient before discharge and beyond. A clear understand-ing of the indications, limitations, and complications of theprocedures must be acquired.

Training in cardiac catheterisationBefore undertaking training in interventional cardiology thetrainee must achieve competence in general cardiology and indiagnostic cardiac catheterisation. The trainee should have com-pleted training in diagnostic cardiac catheterisation procedures as aprimary operator. These should include left heart catheterisationand coronary arteriography, as well as graft studies. Before formaltraining in intervention begins, the trainee is expected to haveassisted in at least 25 PCI procedures. Specialist training should bethe focus of the last 2 years in the SpR training programme.

SelectionTraining institutions should have in place a method of formalassessment and selection for the training places that can with-stand fair scrutiny. The process of selection of an interventionaltrainee differs between institutions with no agreed mechanismnationally. Competitive interviews are recommended. After theselection, ongoing formal assessment throughout the period oftraining is mandatory with clear bidirectional feedback.

If it is considered that training would be appropriate for anindividual but local circumstances are such that the trainingcannot be provided locally, an interdeanery transfer can beconsidered.

Local arrangements with neighbouring centres should beencouraged for trainees to be able to train in techniques notavailable at the host institution.

Procedural numbers and scopeDefining the minimum number of PCI procedures that constitutesan acceptable training in PCI remains difficult. A minimum of 200procedures/year over the 2 years prior to consultant appointmentwith at least 125 as the first operator is the minimum requirement.During these cases the trainee must be fully involved in preproce-dural evaluation of the patient, selection of equipment, discussionof risk and benefits and the outcomes of each intervention. Thetrainee should be directly involved in the reporting of the proced-ure including completion of database archiving, and documenta-tion of any complications up to the time the patient is dischargedfrom hospital. A review of the trainee’s experience and outcomesshould be performed on a regular basis.

Practical skills should be assessed on a competency basis.Completion of a logbook is mandatory for practical proceduresalong with completion of existing educational assessments.Observations by the educational supervisor and by a consultantother than the educational supervisor will be part of the assess-ment methods.

The training should have the following components:▸ Core procedures including vascular access and vascular access

management—including both radial approach and femoralapproach.

▸ Conventional balloon angioplasty.▸ Coronary artery stenting.▸ PCI in the setting of ACS including primary intervention for

STEMI.▸ Pericardial aspiration.▸ Intra-aortic balloon counterpulsation and other techniques of

mechanical circulatory support.▸ Intracoronary imaging.▸ Coronary flow measurements/pressure wire measurements.▸ Use of protection devices.▸ Use of techniques to treat coronary perforation.Experience in other techniques would depend on the expertiseand practice of the institution. These could includepost-Cetrificate of Completion of Training (CCT) training in thefollowing:▸ Rotational atherectomy▸ Embolisation devices (eg, coils)▸ Intravascular foreign body retrieval▸ Adult structural heart intervention including:

– Balloon valvuloplasty.– Transcatheter aortic valve implantation.– Transcatheter closure of congenital/acquired defects.– Left atrial appendage occlusion.For the purpose of training it should be left to the trainer to

determine when a trainee has been the principal (first) operator.The trainee must personally perform the procedures under thedirect supervision of a recognised trainer. The trainer who takesoverall responsibility for the patient must be immediately avail-able in the catheterisation laboratory to supervise the trainee.

Trainees should be exposed to a comprehensive range ofpatient mix and these should include patients with stable anginaand ACS such as unstable angina, acute MI and cardiogenicshock. All trainees should be able to acquire significant experi-ence in the management of patients who require circulatorysupport, particularly with intra-aortic balloon counterpulsation.

Trainees must be familiar with the BCIS/ Central CardiacAudit Database (CCAD) audit requirements for PCI and beaware of and participate in data collection and validation.

EducationBCIS recommends that an interventional training programmeshould hold a regular interventional meeting. This shouldaddress the core curriculum subject matter and should providean opportunity to review both the diagnostic and interventionalcases with respect to patient selection, the performance of theprocedure, clinical outcome and any complications. The MDTmeeting as an integral part of decision making should haveactive involvement of the interventional trainees.

Participation in clinical research by the trainees should be acore requirement for the programme. Trainees should be encour-aged to initiate individual research and participate in trials inwhich the institution is taking part. Trainees should be active par-ticipants in data analysis and presentations and be encouraged toundertake clinical audit and follow-up of patients.

Trainees should spend at least 4 days each year attendingappropriate educational meetings. Participation in the BCISBasic Cardiovascular Intervention Course, The AdvancedCardiovascular Intervention Course for Trainees and annually theAdvanced Cardiovascular Intervention are strongly recommended.Further relevant opportunities for education come in the form of

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international Fellows Courses, and the two major internationalmeetings (Euro-PCR and Transcatheter Therapeutics meeting(TCT)).

TrainersEach institution with an interventional training programmeshould have at least three experienced clinical InterventionalCardiologists who have each performed a minimum of 500 pro-cedures in their careers. Each centre will have a designated train-ing programme Director who will ensure trainee selection,appraisal and assessment. The programme director should havea career experience of a minimum of 1000 coronary interven-tional procedures. An interventional training centre willperform a minimum of 400 PCI procedures a year to allow atrainee to participate in the full spectrum of coronary interven-tion. We recommend that the number of trainees accepted intoa training programme should reflect the institutional volumeand the number of senior trainers available. Generally a PCIprogramme should be an integral component of a comprehen-sive service and should have on-site capabilities including a cor-onary care unit, cardiac surgery, cardiac intensive care andcardiac imaging including echocardiography, cardiac magneticresonance scanning and nuclear cardiology.

High volume PCI programmes without on-site cardiacsurgery provide excellent PCI training and training in thesecentres should be considered as an equivalent to training in asurgical centre. However it is expected that trainees will spendtime training within a surgical centre, and that arrangements aremade to allow interaction with neighbouring on-site surgicalcentre interventional trainers, trainees and cardiac surgeons.

Trainee evaluationThe responsibility for trainee evaluation should reside with theProgramme Director for Education. Regular review of the trai-nee’s feedback along with trainer’s feedback, and presentationof that within the Deanery should occur on an annual basis.The programme director should be responsible for confirmingthat trainees have completed their interventional training satis-factorily as required by the core training requirements.

FUTURE DEVELOPMENTSCommissioningThe RCP/BCS response to the NHSWhite Paper Equity and excel-lence: liberating the NHS,23 is endorsed by BCIS including liaisonat local vascular/chronic disease management board level betweenthe local cardiology service and primary care clinical commission-ing groups. The new Cardiovascular Disease Outcomes Strategy2013 emphasises agreed care pathways for cardiac conditionsacross the local health economy.24 NHS England and clinical com-missioning groups have committed to reviewing, through the spe-cialty’s clinical reference group and local senates/networks,achievements in national cardiac audits including the NICOR,together with local mortality trends, in setting its priories.

Cardiovascular networks are recognised to have an importantrelationship with commissioning and PCI has shown the efficacyof that in the roll-out of network-based PPCI. Service levelagreements should reflect expected outcomes to meet nationalcardiac audit outcomes. These key points for commissionershave been taken from the RCP’s Consultant physicians workingwith patients: The duties, responsibilities and practice of physi-cians in medicine.25 Further information on service organisa-tion, workforce requirements and job plans for cardiologyservices can also be found in this document.

New technologyInterventional cardiologists use and manage a very wide rangeof medicines and medical devices. Within the UK, the MHRA isresponsible for regulating all medicines and medical devices byensuring their safety and efficacy. The MHRA is a centre of theMedicines and Healthcare Products Regulatory Agency whichalso includes the National Institute for Biological Standards andControl (http://www.nibsc.org/) and the Clinical PracticeResearch Datalink (http://www.cprd.com/). The MHRA is anexecutive agency of the Department of Health. Its role includesguidance, safety alerts and links to educational material to assistcardiology practitioners in the safe use and management ofmedicines and medical devices.

NICE provides national guidance and advice to improvehealth and social care. NICE was originally set up in 1999 asthe National Institute for Clinical Excellence, and in 2005, aftermerging with the Health Development Agency, the namechanged to the National Institute for Health and ClinicalExcellence. At this time NICE took on responsibility for devel-oping guidance and quality standards through the work of inde-pendent committees. NICE currently provides guidelines,technology appraisals, guidance on interventional procedures,new medical technologies and use of diagnostic techniques.These currently include guidelines on the use of drug-elutingstents for patients with coronary artery disease.

ResearchResearch is a fundamental part of interventional cardiologyand its scope goes beyond the limits of this document. TheUK has a prominent role in interventional research and this isimportant for patients, interventional teams and the broaderNHS. BCIS supports research in a number of ways whichinclude the R&D group which has as its primary goal thepromotion of interventional research in the UK. The corephilosophy is that the best research is planned, conducted andreported by motivated teams that ‘own’ the project. The BCISR&D committee seeks to facilitate the regular performance ofquality, perhaps collaborative, studies in centres that have notpreviously regarded this as core business, or who haveperhaps been overlooked when research organisations selectpartners.

BCIS also encourages the use of the BCIS audit data set forobservational research, and this has resulted in a number of pub-lications. Applications to use the data set for research can bemade via the NICOR website.

Within the UK the National Institute for Health ResearchClinical Research Network (NIHR CRN) provides healthservice infrastructure (eg, research support staff such as clin-ical research nurses; and research support services such aspharmacy, pathology and radiology) to support clinicalresearch in the NHS in England. The NIHR CRN comprises15 local CRNs and a national coordinating centre whosepurpose is to provide efficient and effective support for theinitiation and delivery of funded research in the NHS. Someof this research is funded by the NIHR, but most of it isfunded by NHS non-commercial partners and industry. Thisactivity makes an important contribution to improve thehealth of the population and to support economic growth;and the NIHR CRN features in the government’s Strategy forUK Life Sciences.

The NIHR CRN allocates and manages funding to meet NHSsupport (eg, additional nursing time; pathology sessions; labcosts; imaging; additional outpatients costs) for eligible studies.

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These comprise randomised controlled clinical trials of interven-tions (including prevention, diagnosis, treatment and care) andother high quality well designed studies. The website http://www.crncc.nihr.ac.uk provides the criteria governing eligibilityof studies for Network support.

BCIS meetings and live casesBCIS has a major role in training and education, with annualSociety meetings and contributions to other national and inter-national forums. These meetings may include lectures anddebates, case-based discussions, angiogram review sessions, andlive case demonstrations to exhibit procedural techniques andnew technologies. Specifically BCIS provides two specialist inter-ventional training courses/year together with an annualAdvanced Cradiac intervention (ACI) meeting and a rotatingautumn meeting.

Audiences at these meetings may include medical and non-medical clinicians; members of the medical technology, device andpharmaceutical industries; members of government agencies orother professions; patients and their representatives; and membersof the general public. Presentations may also include discussion ofcomplications of cardiac interventions that cause morbidity andmortality. Critical review of these cases is an essential componentof audit and education, and should be conducted in a supportiveatmosphere to ensure that colleagues remain willing to present fail-ures as well as successes. Attendance and participation by interven-tionalists at these meetings is very strongly encouraged and is afundamental part of the revalidation process.

BCIS wishes to ensure that participants in all of these activitiesadhere to the highest standards of professional practice and thatthe care and dignity of patients is maintained. The link http://www.bcis.org.uk/resources/C28_BCISRecommendationFPB pro-vides the guidelines for the conduct of BCIS members at meetingand for the conduct of live cases.

Author affiliations1Oxford Heart Centre, Oxford University Hospitals2Department of Cardiology, Bristol Heart Institute Bristol, Bristol, UK3Department of Cardiology, Leeds General Infirmary, Leeds, UK4Southampton University Hospital5Royal Cornwall Hospital Trust Cornwall, Cornwall, UK6UK Manchester Heart Centre Central Manchester University Hospitals NHSFoundation Trust, Manchester University7Queen Elizabeth Hospital Birmingham8The Heart and Lung Centre, Royal Wolverhampton Hospital Trust, Wolverhampton,UK9Cardiology Department, James Cook University Hospital, Middlesbrough, UK10University Hospital of North Staffordshire, Staffordshire, UK11Guys and St Thomas NHS Trust, London, UK

Acknowledgements BCIS is grateful to Ellie Gudde, Senior Sister EssexCardiothoracic Centre, Sarah Carson, Catheter Laboratory Manager, Bristol RoyalInfirmary, Catherine Theron, Unit Manager, Morriston Hospital and Dr Rod Stables,Interventional Cardiologist in Liverpool for their assistance with the preparation ofthis document.

Contributors The document is a consensus document, and each of the authorshave been involved in the concept, writing, reviewing and submission.

Competing interests APB has received a grant to establish an Oxford-basedtraining fellowship from Boston Scientific. DB is a paid proctor by Boston Scientificand Medtronic Corp.

Provenance and peer review Not commissioned; externally peer reviewed.

Open Access This is an Open Access article distributed in accordance with theCreative Commons Attribution Non Commercial (CC BY-NC 4.0) license, whichpermits others to distribute, remix, adapt, build upon this work non-commercially,and license their derivative works on different terms, provided the original work isproperly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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22 http://www.bcis.org.uk/pages/page_box_contents.asp?pageid=678&navcatid=25(accessed 23 Dec 2014).

23 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213823/dh_117794.pdf (accessed 23 Dec 2014).

24 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/217118/9387-2900853-CVD-Outcomes_web1.pdf (accessed 23 Dec 2014).

25 https://www.rcplondon.ac.uk/sites/default/files/consultant_physicians_revised_5th_ed_full_text_final.pdf (accessed 23 Dec 2014).

26 Athappan G, Patvardhan E, Tuzcu ME, et al. Left main coronary artery stenosis:a meta-analysis of drug-eluting stents versus coronary artery bypass grafting.JACC Cardiovasc Interv 2013;6:1219–30.

27 Serruys PW, Morice MC, Kappetein AP, et al. Percutaneous coronary interventionversus coronary-artery bypass grafting for severe coronary artery disease. N Engl JMed 2009;360:961–72.

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28 Kahn JK. Angiographic suitability for catheter revascularization of total coronaryocclusions in patients from a community hospital setting. Am Heart J 1993;126:561–4.

29 Koolen J, on behalf of the SYNTAX investigators. Optimal revascularizationstrategies in patients with total occlusions: 1 year results from the Syntax Trial.Presented at Japanese Circulation Society meeting 2009. 2009.

30 Werner G. Updates from the Euro CTO club. Presented at the Chronic TotalOcclusion and Left Main Summit. 2013.

31 Joyal D, Afilalo J, Rinfret S. Effectiveness of recanalization of chronictotal occlusions: a systematic review and meta-analysis. Am Heart J2010;160:179–87.

32 Morino Y, Abe M, Morimoto T, et al. Predicting successful guidewire crossingthrough chronic total occlusion of native coronary lesions within 30 minutes: theJ-CTO (Multicenter CTO Registry in Japan) score as a difficulty grading and timeassessment tool. JACC Cardiovasc Interv 2011;4:213–21.

APPENDIX 1: LEFT MAIN STEM DISEASEThere is a very extensive literature of observational and rando-mised trials that have evaluated revascularisation in patientswith left main disease. This literature has been extensively sum-marised in the 2014 ESC and the 2011 ACCF/AHA/SCAIguidelines.1 14

In the pre percutaneous coronary intervention (PCI) era, cor-onary artery bypass grafting was the only option available forrevascularisation in patients with significant left main disease.Subgroup analyses from the CASS registry and meta-analysis ofseveral randomised controlled trials (enrolling a total of >2500patients) indicated that, when compared with what we wouldnow consider to be inadequate medical therapy, coronary arterybypass grafting (CABG) significantly improved survival in thesepatients. Multiple trials have reported on outcomes comparingCABG and PCI for the treatment of left main coronary disease.A recent meta-analysis of over 14 000 patients enrolled in com-parative trials of the two techniques reported no significant dif-ference for all-cause mortality over a 5-year follow-up period.26

Recurrent ischaemia and repeat revascularisation procedureswere significantly more common in patients undergoing PCI forleft main disease compared with CABG. The occurrence ofstroke was less frequent in patients treated with PCI.

The most reliable contemporary data comparing PCI withdrug-eluting stents or CABG for left main coronary disease isprovided by the SYNTAX trial.27 In SYNTAX, 705 of the 1800patients randomised had left main coronary disease. When thepatients were grouped according to a measure of the complexityand extent of their coronary disease, using the SYNTAX score, aclear pattern emerges. In patients with less complex disease (lowor intermediate SYNTAX score) CABG confers no survivaladvantage over PCI. For patients with more complex disease(manifest as a SYNTAX score greater than 33) CABG reducesmortality by a considerable extent.

Performing PCI in the left main stem should always beregarded as a challenging procedure. Operators and their cath-eterisation laboratory teams need to be experienced and profi-cient in rapidly responding to a sudden unplanned deteriorationand the requirement for complex bailout stenting strategies. Insome circumstances, rapid and effective deployment of haemo-dynamic support devices can be life-saving. It is important thatthese are immediately available and can be inserted and acti-vated rapidly

Adherence to these standards will provide the best chance ofa good patient outcome. The documented outcomes reported inthe literature have been obtained by expert PCI teams. In cir-cumstances when these minimal standards cannot be met, alter-native referral is advised to a suitably equipped and experiencedinterventional colleague/centre. Preprocedural planning in leftmain stem cases requires multidisciplinary team (MDT) discus-sion and then careful evaluation, and this usually extendsbeyond the basic information provided by angiography alone.Preprocedure including intravascular ultrasound (IVUS) and/ormeasurement of fractional flow reserve is recommended to char-acterise the anatomical and haemodynamic features of thelesion, and guide stent sizing and procedural technique. There is

often considerable difficulty in optimally sizing stents, and IVUSor optical coherence tomography should be performed afterstent deployment to ensure that a good result with optimal stentapposition has been obtained.

In many patients with left main disease coronary calcificationis common and the potential for adjunctive plaque modificationto facilitate optimal stent implantation is high. This may notalways be readily apparent on angiography, further emphasisingthe value of IVUS for preprocedure planning. Centres andoperators performing left main intervention should ensure thatthey are proficient in the use of rotational atherectomy, and thatthis is available when performing urgent/elective PCI to the leftmain coronary.

Key points: left main coronary intervention

▸ When patients present with coronary instability associatedwith a culprit lesion in the left main, reduced antegradecoronary flow and clinical instability, PCI should beconsidered if the patient’s clinical condition precludesperforming CABG.

▸ In more stable patients, discussion by a multidisciplinaryteam is the recommended way of selecting an optimalrevascularisation strategy.

▸ Availability of intra-aortic balloon counter-pulsation pump(IABP), IVUS, rotational atherectomy, and pressure wiresystems are mandatory for left main intervention proceduresalong with the necessary expertise.

APPENDIX 2: CHRONIC TOTAL OCCLUSIONSChronic total occlusions (CTOs) are identified in up to a third ofcoronary angiograms28 but are relatively under-represented in per-cutaneous coronary intervention (PCI) practice. CTOs wereapproached in only 5% of all PCIs and in 15% of stable cases inthe UK in 2012.12 Reasons for this imbalance may include lowerPCI procedural success rates, perceived or real superiority of surgi-cal revascularisation, or an assumption that medical therapy aloneis the only option for all but the simplest CTO lesion. However,surgical success is not assured for CTOs—only 68% of CTOs weresuccessfully bypassed in the Syntax Trial29 and success rates for PCIof 85% have been reported by CTO operators in Europe.30

High reported success rates for CTO PCI are likely to berelated to development of more complex techniques, such as theretrograde approach and dissection/re-entry, in addition toimprovements in specific procedural tools, for example, dedi-cated CTO wires, microcatheters (eg, Corsair, Tornus) and spe-cialised re-entry equipment (Crossboss catheter, stingray wireand stingray balloon). For complex cases and techniques, itseems highly likely that case volume will have a part to play inpredicting success.

Although observational data exists suggesting prognostic gainfrom CTO PCI,31 no randomised trial data exist which

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demonstrate improvement in prognosis. The primary indicationfor CTO PCI therefore remains symptomatic improvement.Patients should be established on optimal medical therapybefore being scheduled for PCI, but the bar need not be sethigher than for other patients with stable angina and there is norequirement for multiple antianginals in maximum doses beforePCI is considered.

Ad hoc PCI for CTOs should not be performed. It is recom-mended that angiograms in which a CTO is identified are pre-sented to a multidisciplinary team (MDT). This should act as asafeguard against inappropriate conservatism and ensure thatthe most appropriate form of revascularisation is selectedaccording to patient and anatomical factors.

Information presented to the MDT should include: symptomburden; current medical therapy; results of non-invasive testsfor viability and ischaemia; comorbidities which may affect thesafety of PCI (especially chronic kidney disease, peripheral vas-cular disease and conditions which might limit the safe use ofDES). J-CTO score, Syntax score and Euroscore II should becalculated and recorded.

Several anatomical factors have been identified which predictCTO PCI success in contemporary practice and these have beenincorporated into the J-CTO score.32 Low J-CTO scores arehighly predictive of rapid antegrade wire crossing and ultimatecase success and therefore may assist in determining the settingin which PCI is to be performed.

According to local practice, cases with J-CTO score of 0 inwhom rapid antegrade wiring is considered likely may be reasonablytreated by either ‘non-CTO operators’ or indeed by CTO teams.

Since success is not assured and complications are higher withmore complex techniques, all but the simplest ( J-CTO score 0)cases should be performed by dedicated CTO operators incentres with appropriate facilities.1 Dedicated CTO operatorsshould have the full skill set to escalate from simple antegradewiring to retrograde and dissection/re-entry at the same sitting.Dual arterial access is strongly encouraged unless no contralat-eral filling of the CTO vessel is seen.

A full range of equipment—including a range of CTO wires,short guide catheters for retrograde access, microcatheters, small

over-the-wire balloons, snares, including intravascular ultrasound(IVUS) and catheter extension devices—should be available andthe operator should be familiar with it. Emergency bailout kitshould be immediately available in the catheter lab—echocardiog-raphy, pericardiocentesis and microvascular coils for perforations.

Adequate time should be set aside in the lab schedule toperform CTO PCI, which may be lengthy. Dual operator casesmay be advantageous, especially with the most complex lesionsincluding reattempts. Operators should liaise with local radi-ation protection advisors in order to set dose reference levelsfor CTOs. Close attention should be paid to radiation protec-tion measures for operators—eye shields, table skirts, eyewearand disposable protection drapes should be available.Angiographic views should be altered during long cases andrepeat procedures should be staged to reduce the risk of loca-lised skin damage to patients. Ensuring patient safety is para-mount and complex CTO procedures should always beperformed in centres where colleagues with appropriate CTOexperience are available to assist. Operators should carefullyconsider whether a complex CTO case would be most safelyperformed in a site with on-site cardiac surgery.

Restenosis is more common in CTO cases, at least partlyrelated to the common requirement for long segment coverage.Drug-eluting stent use should therefore be the routine so anassessment of likely tolerability of prolonged dual antiplatelettherapy (DAPT) is required. Potential problems with DAPTshould be highlighted and discussed at MDT.

Key points: Ad hoc CTO PCI should not be performed

▸ All CTOs should be discussed at MDT regardless of initialintended therapy.

▸ Complexity scoring of the CTO is recommended for all cases.▸ All complex cases should be discussed with and/or

performed by dedicated CTO operators.▸ Drug-eluting stent use is strongly encouraged.

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