balloon sinuplasty-slides-091216

Balloon Sinuplasty

Ki-Hong Kevin Ho, MD

Patricia Maeso, MD

Department of Otolaryngology

University of Texas Medical Branch

Grand Rounds Presentation

December16, 2009

IntroductionIntroduction•31 million 31 million

Americans suffer Americans suffer from chronic from chronic sinusitissinusitis

•Surgical treatment Surgical treatment for chronic sinusitis for chronic sinusitis has evolved has evolved tremendously tremendously since its inceptionsince its inception

Historical perspectivesHistorical perspectives

• End of 19End of 19thth century: century: – George Caldwell and Henri Luc described the canine George Caldwell and Henri Luc described the canine

fossa approach to maxillary sinusfossa approach to maxillary sinus

• 1901:1901:– Hirschman was the first to perform nasal endoscopy Hirschman was the first to perform nasal endoscopy

using a modified cystoscopeusing a modified cystoscope

• 1960:1960:– Hopkins rod telescope was patentedHopkins rod telescope was patented

• 1978:1978:– Messerklinger published a landmark collections of Messerklinger published a landmark collections of

endoscopic imagesendoscopic images

• 1980s:1980s:– Stammberger published a series of papers on FESSStammberger published a series of papers on FESS

Balloon technologyBalloon technology•Available in other Available in other

specialties specialties cardiology, cardiology, gastroenterology, gastroenterology, endovascular endovascular surgery, and urologysurgery, and urology

•Angioplasty has Angioplasty has effectively provided effectively provided an alternative to open an alternative to open heart surgeryheart surgery

ARS position statement on ARS position statement on balloon sinuplasty (2006)balloon sinuplasty (2006)

• -- Balloon dilation technology may have potential -- Balloon dilation technology may have potential application where surgical management of sinus application where surgical management of sinus disease is required.disease is required.

-- The technology has limited surgical indications at -- The technology has limited surgical indications at this time.this time.

-- Patients treated with balloon dilation may still -- Patients treated with balloon dilation may still require conventional sinus surgery.require conventional sinus surgery.

-- In a small group of very selected patients, the -- In a small group of very selected patients, the use of balloon dilation technology alone may use of balloon dilation technology alone may eliminate the need for other surgical procedures.eliminate the need for other surgical procedures.

ManufacturersManufacturers

• Three companies that manufacture balloon Three companies that manufacture balloon catheters have reported their use in catheters have reported their use in endoscopic sinus surgery: endoscopic sinus surgery:

• Acclarent, Inc (Menlo Park, CA, USA)Acclarent, Inc (Menlo Park, CA, USA)

• Quest Medical, Inc (Allen, TX, USA)Quest Medical, Inc (Allen, TX, USA)

• Entellus Medical, Inc (Maple Grove, Entellus Medical, Inc (Maple Grove, MN, USA)MN, USA)

Acclarent, IncAcclarent, Inc• Based in Menlo Park, CABased in Menlo Park, CA

• Started investigation in sinuplasty in Started investigation in sinuplasty in 20022002

• Fluoroscopic confirmationFluoroscopic confirmation

• Lighted guidewire called LUMA recently Lighted guidewire called LUMA recently releasedreleased

Acclarent Relieva sinus Acclarent Relieva sinus cathetercatheter

Schematics of Balloon Schematics of Balloon SinuplastySinuplasty

Luma Sinus Illumination Luma Sinus Illumination System (Luma light)System (Luma light)

Friedman M.Laryngoscope. 2009 Jul;119(7):1399-402.

Comparison of Luma and Comparison of Luma and fluoroscopyfluoroscopy

Friedman M.Laryngoscope. 2009 Jul;119(7):1399-402.

Initial study 1: Bolger et Initial study 1: Bolger et al. (2006)al. (2006)

– 6 human cadever heads, 6 human cadever heads, – CT before and after balloon dilationCT before and after balloon dilation– Catheters successfully dilated 31 of 31 ostia:Catheters successfully dilated 31 of 31 ostia:

•9 maxillary, 11 sphenoid, and 11 frontal 9 maxillary, 11 sphenoid, and 11 frontal recessesrecesses

– Mucosal trauma appeared to be less than that Mucosal trauma appeared to be less than that normally seen with standard endoscopic normally seen with standard endoscopic instruments. instruments.

– Minimal trauma to surrounding structures such as Minimal trauma to surrounding structures such as the orbit or skull base per CT and nasal endoscopythe orbit or skull base per CT and nasal endoscopy

Initial study 2: Brown et al. Initial study 2: Brown et al.

(2006)(2006) – Prospective non-randomized cohortProspective non-randomized cohort– 10 patients, 18 sinuses 10 patients, 18 sinuses

•10 maxillary, 3 frontal, 5 sphenoid10 maxillary, 3 frontal, 5 sphenoid– Exclusion criteria:Exclusion criteria:

•Age < 18Age < 18

•CFCF

•Significant nasal polyposisSignificant nasal polyposis

•Sinus osteoneogenesisSinus osteoneogenesis

•Previous FESSPrevious FESS– Fluoroscopic guidance with C armFluoroscopic guidance with C arm– Balloon inflated to mean pressure of 13 atm Balloon inflated to mean pressure of 13 atm

(range: 10-16)(range: 10-16)

Maxillary ostium after Maxillary ostium after balloon dilationballoon dilation

Brown C et al. Ann Otol Rhinol Laryngol 2006;115:293–9.

Brown et al. (2006) Brown et al. (2006) resultsresults

– No adverse eventsNo adverse events– Minimal bleedingMinimal bleeding– High degree of mucosal preservationHigh degree of mucosal preservation– Ease of dilation: Sphenoid > frontal > maxillaryEase of dilation: Sphenoid > frontal > maxillary– Mild difficulty in dilating maxillary sinus in 5 of Mild difficulty in dilating maxillary sinus in 5 of

10 patients10 patients– Disadvantage: Difficulty to examine ostia Disadvantage: Difficulty to examine ostia

postop (uncinate, ethmoid cells not removed)postop (uncinate, ethmoid cells not removed)– Weakness of the study: Weakness of the study:

•Small # patientsSmall # patients

•No quality of life evaluation No quality of life evaluation

Levine et al (2008)Levine et al (2008)• PatiENT Registry retrospective reviewPatiENT Registry retrospective review

• Multi-center, 27 ENT practicesMulti-center, 27 ENT practices

• 1036 patients, 3276 sinuses treated1036 patients, 3276 sinuses treated

• 1438 Maxillary, 1284 frontal, 554 sphenoid1438 Maxillary, 1284 frontal, 554 sphenoid

• No major adverse eventsNo major adverse events

• 2 CSF leaks from ethmoidectomy done by 2 CSF leaks from ethmoidectomy done by standard FESSstandard FESS

• 41 of 3276 sinuses required revision (1.3%)41 of 3276 sinuses required revision (1.3%)

• 95% patients with symptom improvement 95% patients with symptom improvement

• Less debridement required for balloon only vs. Less debridement required for balloon only vs. hybridhybrid

Measurement of success Measurement of success in balloon sinuplastyin balloon sinuplasty

•SNOT-20SNOT-20

•CT sinusCT sinus

•Lund-Mackay CT scoreLund-Mackay CT score

•Nasal endoscopy to look for Nasal endoscopy to look for ostia patencyostia patency

Sino Nasal Outcome Test Sino Nasal Outcome Test (SNOT-20)(SNOT-20)

•0 = Not present/no problem0 = Not present/no problem

•1 = Very mild problem1 = Very mild problem

•2 = Mild or slight problem2 = Mild or slight problem

•3 = Moderate problem3 = Moderate problem

•4 = Severe problem4 = Severe problem

•5 = Problem as “bad as it can 5 = Problem as “bad as it can be”be”

SNOT - 20 SNOT - 20

Weiss RL et al. Otolaryngol Head Neck Surg. 2008 Sep;139(3 Suppl 3):S38-46.

Lund- Mackay scoresLund- Mackay scores

Ostial patencyOstial patency

Bolger WE et al. Otolaryngol Head Neck Surg 2007;137:10–20.

CLEAR study CLEAR study

• CLinical Evaluation to confirm sAfety and efficacy of CLinical Evaluation to confirm sAfety and efficacy of sinuplasty in the paRanasal sinusessinuplasty in the paRanasal sinuses

• Multi-center prospective non-randomized studyMulti-center prospective non-randomized study– Bolger et al. (2007): 10 centers (24-week , 109 Bolger et al. (2007): 10 centers (24-week , 109

patients)patients)– Kuhn et al. (2008): 7 centers (1 year f/u, 66 Kuhn et al. (2008): 7 centers (1 year f/u, 66

patients)patients)– Weiss et al. (2008): 6 centers (2 years f/u, 65 Weiss et al. (2008): 6 centers (2 years f/u, 65

patients) patients)

Goals of CLEAR studyGoals of CLEAR study• 1) To evaluate the effectiveness of balloon 1) To evaluate the effectiveness of balloon

cathetercatheter

• devices in relieving sinus ostial obstruction devices in relieving sinus ostial obstruction and in maintaining sinus ostia patencyand in maintaining sinus ostia patency

• 2) To confirm the safety of sinusotomy using 2) To confirm the safety of sinusotomy using balloon catheters in a larger patient groupballoon catheters in a larger patient group

• 3) To gain insight into the ability of 3) To gain insight into the ability of sinusotomy with balloon catheters to relieve sinusotomy with balloon catheters to relieve sinus symptoms, either alone or in sinus symptoms, either alone or in combination with standard endoscopic sinus combination with standard endoscopic sinus surgery techniques.surgery techniques.

Inclusion & Exclusion Inclusion & Exclusion criteriacriteria• Inclusion criteria :Inclusion criteria :

– Adult > age of 18 years Adult > age of 18 years – Chronic sinusitis unresponsive to medical Chronic sinusitis unresponsive to medical

managementmanagement

• Exclusion criteria: Exclusion criteria: – Extensive sinonasal polyps, cystic fibrosisExtensive sinonasal polyps, cystic fibrosis– Extensive previous sinonasal surgeryExtensive previous sinonasal surgery– Extensive sinonasal osteoneogenesisExtensive sinonasal osteoneogenesis– Sinonasal tumors,Sinonasal tumors,– History of facial trauma History of facial trauma – Ciliary dysfunctionCiliary dysfunction– PregnancyPregnancy

CLEAR study designCLEAR study design• 3 parts, starting with 24-week data, followed by 1-3 parts, starting with 24-week data, followed by 1-

year data and then by 2-year datayear data and then by 2-year data

• Start off with 109 patientsStart off with 109 patients

• 2 arms2 arms– Balloon sinuplasty combined with traditional Balloon sinuplasty combined with traditional

FESS (hybrid)FESS (hybrid)– Balloon sinuplasty aloneBalloon sinuplasty alone

• Nasal endoscopy to access ostia patencyNasal endoscopy to access ostia patency

• CT sinus/ Lund Mackay scoresCT sinus/ Lund Mackay scores

• SNOT-20 survey for sinus symptomsSNOT-20 survey for sinus symptoms– PreopPreop– 24 weeks, 1 year, 2 years postop24 weeks, 1 year, 2 years postop

Weiss 2 year study Weiss 2 year study (2008)(2008)

• Continuation of CLEAR and Kuhn studyContinuation of CLEAR and Kuhn study

• Prospective multi-center studyProspective multi-center study

• 65 patients and 195 sinuses65 patients and 195 sinuses

• 34 patients “balloon only”, 31 hybrid 34 patients “balloon only”, 31 hybrid (FESS + balloon)(FESS + balloon)

• Septoplasty and turbinectomy also Septoplasty and turbinectomy also performed in a subset of patients performed in a subset of patients (more in the hybrid group)(more in the hybrid group)

• 32 patients with CT scan at 2 years32 patients with CT scan at 2 years

CLEAR study – SNOT 20 CLEAR study – SNOT 20 resultsresults• Preop: Preop:

– Balloon: Balloon: 2.092.09– Hybrid:Hybrid: 2.272.27

• 24 week:24 week:– Balloon: Balloon: 1.07 (p< 0.0001)1.07 (p< 0.0001)– Hybrid:Hybrid: 0.920.92 (p< 0.0001)(p< 0.0001)

• 1 year:1 year:– Balloon:Balloon: 0.990.99– Hybrid:Hybrid: 0.68 0.68

• 2 years:2 years:– Balloon:Balloon: 1.091.09– Hybrid:Hybrid: 0.640.64

SNOT - 20 SNOT - 20

Weiss RL et al. Otolaryngol Head Neck Surg. 2008 Sep;139(3 Suppl 3):S38-46.

SNOT-20 scores summarySNOT-20 scores summary

CT sinus: Maxillary CT sinus: Maxillary

Preop 2 years postop

Weiss RL et al. Otolaryngol Head Neck Surg. 2008 Sep;139(3 Suppl 3):S38-46.

CT sinus: SphenoidCT sinus: Sphenoid

Kuhn FA. Otolaryngology–Head and Neck Surgery (2008) 139, S27-S37

Preop 1 year postop

CT sinus: FrontalCT sinus: Frontal

Kuhn FA. Otolaryngology–Head and Neck Surgery (2008) 139, S27-S37

Preop 1 year postop

CLEAR STUDY- CLEAR STUDY- CT Lund-Mackay scoresCT Lund-Mackay scores

• Preop: Preop: – Balloon: Balloon: 5.675.67– Hybrid:Hybrid: 12.0512.05

• 24 week:24 week:– Balloon: Balloon: No data No data– Hybrid:Hybrid: No data No data

• 1 year:1 year:– Balloon:Balloon: 1.13 1.13 (p=0.07)(p=0.07)– Hybrid:Hybrid: 1.13 1.13 (p<0.001)(p<0.001)

• 2 years:2 years:– Balloon:Balloon: 1.75 1.75 (p=0.02)(p=0.02)– HybridHybrid :: 3.25 3.25 (p<0.001) (p<0.001)

Ostia patency: frontalOstia patency: frontal

Intraop 9 months postop

ANC

MT

Kuhn FA. Otolaryngology–Head and Neck Surgery (2008) 139, S27-S37

Ostia patency by nasal Ostia patency by nasal endoscopyendoscopy

Kuhn FA. Otolaryngology–Head and Neck Surgery (2008) 139, S27-S37

Pediatric populationPediatric population• Ramadan et al (2008)Ramadan et al (2008)

– Prospective study of 30 childrenProspective study of 30 children– Failed medical therapy and confirmed CRS on CT Failed medical therapy and confirmed CRS on CT – Exclude CF, immunodeficient, ciliary dysmotility patientsExclude CF, immunodeficient, ciliary dysmotility patients– Use of C-arm / fluoroscopyUse of C-arm / fluoroscopy– 56 sinuses (48 maxillary, 6 sphenoid, 2 frontal)56 sinuses (48 maxillary, 6 sphenoid, 2 frontal)– 5 mm balloon5 mm balloon– Successful dilation in 51/ 56 sinuses (91%)Successful dilation in 51/ 56 sinuses (91%)– Adenoidectomy performed in 13/30 cases (younger Adenoidectomy performed in 13/30 cases (younger

children)children)– Reason for failure: 4 hypoplastic maxillary sinuses, 1 Reason for failure: 4 hypoplastic maxillary sinuses, 1

frontal frontal – No complicationsNo complications– No quality of life or follow up informationNo quality of life or follow up information

LacriCATH by Quest medical LacriCATH by Quest medical (Allen, Tx)(Allen, Tx) • Opthalmologist has Opthalmologist has

used this to treat used this to treat nasolacrimal duct nasolacrimal duct obstructionobstruction

• Off label for use in Off label for use in sinus ostia sinus ostia obstructionobstruction

• Catheters with Catheters with balloon at the end of balloon at the end of a malleable (no a malleable (no guide wire needed) guide wire needed)

LacriCATH studyLacriCATH study

• Citardi (2007)Citardi (2007)– Cadaver studyCadaver study– 9-mm balloon9-mm balloon– No fluoroscopy usedNo fluoroscopy used– Maxillary sinus dilation Maxillary sinus dilation

successfully performed in successfully performed in only 3 of 6 sinuses only 3 of 6 sinuses

• Atkins (2009)Atkins (2009)– Report successful dilatation Report successful dilatation

of 6 frontal sinus ostia in of 6 frontal sinus ostia in the office setting without the office setting without the use of fluoroscopy.the use of fluoroscopy.

Entellus Medical, IncEntellus Medical, Inc

• Direct access to maxillary sinus through Direct access to maxillary sinus through canine fossa puncture with a small trocarcanine fossa puncture with a small trocar

• Direct visualization of natural ostium via Direct visualization of natural ostium via 0.5 mm flexible endoscope0.5 mm flexible endoscope

Radiation exposure in Radiation exposure in fluoroscopyfluoroscopy

• Radiation to the eyes can cause damage Radiation to the eyes can cause damage to the proliferating cells in the epithelium, to the proliferating cells in the epithelium, ultimately leading to cataract formation.ultimately leading to cataract formation.

• Cataract threshold: acute doses of 2 Gy Cataract threshold: acute doses of 2 Gy or 4 Gy in 3 months or 4 Gy in 3 months

• Balloon sinuplasty fluoroscopy: ~ 4 mGy Balloon sinuplasty fluoroscopy: ~ 4 mGy per eye per eye

• Luma illumination provides an alternative Luma illumination provides an alternative to limit radiation to both patients and to limit radiation to both patients and surgeonssurgeons

Cost Cost •Friedman et al. (2008) Friedman et al. (2008)

•Primary surgery:Primary surgery:– Traditional FESS: Traditional FESS: $ 13,574$ 13,574– Balloon sinuplasty:Balloon sinuplasty: $ 14,021 $ 14,021

(p=.55) (p=.55)

•Revision surgery:Revision surgery:– Traditional FESS:Traditional FESS: $ 16,190$ 16,190– Balloon sinuplasty:Balloon sinuplasty: $ 10, 346$ 10, 346

(p< .0001)(p< .0001)

CodingCoding• Use of “pure” sinuplasty requires the Use of “pure” sinuplasty requires the

use of CPT Unlisted Code 31299.use of CPT Unlisted Code 31299.

• For hybrid procedures, use FESS For hybrid procedures, use FESS codes:codes:– Maxillary: Maxillary: 31256 / 31267 (tissue 31256 / 31267 (tissue

removal)removal)– Sphenoid:Sphenoid: 31287/ 3128831287/ 31288– Frontal: Frontal: 3127631276

PainPain•Well tolerated by most patients.Well tolerated by most patients.

•Friedman et al. (2008) on narcotic pain Friedman et al. (2008) on narcotic pain meds durationmeds duration– Traditional FESS:Traditional FESS: 1.34 days1.34 days– Balloon sinuplasty:Balloon sinuplasty: 0.8 days 0.8 days

(p=0.011)(p=0.011)

•BREATHE-1 trial (2007)BREATHE-1 trial (2007)– Narcotic pain meds rarely neededNarcotic pain meds rarely needed

•Less postoperative debridementLess postoperative debridement

Sinuplasty: A new toolSinuplasty: A new tool

• ““Sinuplasty is a new technique in performing Sinuplasty is a new technique in performing endoscopic sinus surgery—not a new endoscopic sinus surgery—not a new procedure but rather a new tool that further procedure but rather a new tool that further reduces mucosal damage and advances us reduces mucosal damage and advances us toward our ultimate goal of improving toward our ultimate goal of improving function with maximal mucosal preservation.”function with maximal mucosal preservation.”

Raymond Weiss, MD

Conclusions:Conclusions:• Balloon sinuplasty is a novel technology for Balloon sinuplasty is a novel technology for

otolaryngologistsotolaryngologists

• It is a safe technique with low morbidityIt is a safe technique with low morbidity

• It is shown to improve patient symptoms in It is shown to improve patient symptoms in data of 2 year follow up in a selected group of data of 2 year follow up in a selected group of patients patients

• It holds promises for office type sinus It holds promises for office type sinus proceduresprocedures

• More study is needed to define its role in sinus More study is needed to define its role in sinus surgery in particular patient selection and surgery in particular patient selection and disease type best suited for this technologydisease type best suited for this technology

Thank you Thank you Thank You