Learner Objectives. Overview. Minimally Invasive Sinus Surgery: What is the data for Balloon Catheter Dilation 7/31/2017

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1 Minimally Invasive Sinus Surgery: What is the data for Balloon Catheter Dilation David M. Poetker, MD Christopher M. Long, MD Rhinology and Sinus Surgery Medical College of Wisconsin Thank you to Susan Fulmer, MD and Jessica Southwood, MD for slide preparation Learner Objectives After this presentation you should: 1) Be familiar with the history of balloon dilation 2) Be familiar with the data supporting balloon dilation 3) Be familiar with the limitations of balloons Overview History Literature review Pro-balloon data/viewpoint Contra-balloon data/viewpoint Questions 1

2 Overview History Literature review Pro-balloon data/viewpoint Contra-balloon data/viewpoint Questions Balloon Catheter Technology Urology Gastroenterology Cardiology Ophthalmology Otolaryngology History Late 1990 s Reports of fogarty catheters used for sinus dilatation 2002 Engineers modified angioplasty technology for sinuses Surgeons consulted Acclarent Inc. (Menlo Park, CA) born 2

3 History 2005 FDA approval for Balloon Sinuplasty (Acclarent, Inc., Menlo Park, CA) Unlike traditional balloons (compliant and conform to anatomy), this device was noncompliant, able to displace bone and tissue Balloon catheter dilation Dilate sinus ostia Preserve mucosa Reduce pain Decrease bleeding Mold bone Reduced pain Quicker recovery Balloon catheter dilation BCD does not remove tissue Typically not recommended for CRSwNP or eosinophilic disease Tissue removal and widening of the outflow tract by removal of frontal recess cells is necessary for topical drug delivery 30 Contraindicated if there is suspicion or documentation of neoplastic disease 31 3

4 Balloon catheter dilation BCD fractures and laterally displaces the medial and superior wall of obstructing frontal cells, medially displaces the intersinus septal cell wall, and dilates soft tissue stenosis in revision cases 30 Sillers MJ, Lay KF. Otolaryngologic clinics of North America. 2016;49(4): cadavers 31 dilated ostia 9 maxillary, 11 sphenoid, 11 frontal Results 31/31 successful dilations No damage to the orbit or skull base Bolger WE, Vaughan WC. Am J Rhinol, Pre dilation Post dilation Bolger WE, Vaughan WC. Am J Rhinol,

5 Bolger WE, Vaughan WC. Am J Rhinol, First-in-man study 10 patients c refractory CRS 18 sinuses 10 maxillary, 5 sphenoid, 3 frontal Results 18/18 successfully dilated with minimal trauma No adverse events Sphenoid easiest to dilate Maxillary most difficult (uncinectomy required in ½) Brown CL, Bolger WE. Ann Otol Rhinol Laryngol, Undilated balloon catheter Dilated balloon catheter across ostium Brown CL, Bolger WE. Ann Otol Rhinol Laryngol,

6 Marketing of Balloon Sinuplasty TM NOVEL technique New unique coding and billing nomenclature Delays in reimbursement Change in marketing emphasis new TOOL Soft tissue shavers, thru-cutting instruments, drills, or lasers Code as conventional FESS This is a wonderful, wonderful advantageous technology for patients. The bones in the sinus drain are very soft, thin bones. Extremely malleable and therefore there is no pain. Peter Catalano, MD Lahey Clinic It allows for no incisions or cutting. There's no bruising or swelling. Howard Levine, MD Cleveland Nasal/Sinus Center Controversy Initial studies showed proof of concept in limited patients without follow-up Batra PS, et al. Laryngoscope

7 The hype may be getting ahead of the science, say some leading sinus specialists, who concede that sinuplasty may hold promise. They see the rush to embrace balloon sinuplasty as an example of how the loose regulation of medical devices can enable procedures to be adopted more on the basis of astute marketing than clinical science NY Times, costly but novel application of existing technologies that may find some role in the rhinology marketplace.however, there is real concern that as a result of misstatements in the press and on the company web site, patients may have wrongfully been misled into believing that it is already a superior technology. Lanza DC, Kennedy DW. Ann Otol Rhinol Laryngol, Overview History Literature review Pro-balloon data/viewpoint Contra-balloon data/viewpoint Questions 7

8 BREATHE I trial 30 subjects with isolated maxillary and/or anterior ethmoid disease Results: 95% successfully treated 73% received local anesthesia & IV sedation, 23% local anesthesia alone 3/30 tooth or face numbness 1/30 required further surgery Mean SNOT 20 score Improved SNOT 20 at 1 week, 3 months, and 6 months 95% OMU patency on CT at 3 months Stankiewicz J, et al. Am J Rhinol Allergy, Cutler J, et al. Int For Aller Rhinol, CLEAR study Multicenter prospective study, 10 sites 115 subjects at 10 centers: Adults with medical refractory CRS Excluded those with polyps, extensive previous sinonasal surgery, extensive osteoneogenesis, CF, sinonasal tumors, and ciliary dysfunction 52% hybrid procedures, 48% balloon sinuplasty alone 24 week, 1 year, and 2 year follow-up 8

9 CLEAR study Bolger WE, et al. Otolaryngol Head Neck Sug, Kuhn FA, et al. Otolaryngol Head Neck Surg, Weiss RL, et al. Otolaryngol Head Neck Surg, CLEAR study Bolger WE, et al. Otolaryngol Head Neck Sug, Kuhn FA, et al. Otolaryngol Head Neck Surg, Weiss RL, et al. Otolaryngol Head Neck Surg, CLEAR study Sinus patency (endoscopy) 24 wks 1 yr * Maxillary sinus 91% 90% Frontal sinus 82% 85% Sphenoid sinus 60% 72% No reported adverse outcomes CSF leak, orbital injury, bleeding requiring packing * Not reported in 2 year follow up study. Bolger WE, et al. Otolaryngol Head Neck Sug, Kuhn FA, et al. Otolaryngol Head Neck Surg, Weiss RL, et al. Otolaryngol Head Neck Surg,

10 CLEAR study- limitations Single armed, uncontrolled, observational study No comparison group Patient population not clearly defined Symptom duration and distribution of disease severity not provided No explicit criteria for diagnosis, medical and surgical management SNOT-20- single administration may not be reliable Bolger WE, et al. Otolaryngol Head Neck Sug, Kuhn FA, et al. Otolaryngol Head Neck Surg, Weiss RL, et al. Otolaryngol Head Neck Surg, Retrospective review of 1036 patients who had 3276 sinuses treated. Reinforces a favorable device safety profile. Identified 2 CSF leaks and 6 minor bleeds. All 8 cases done in conjunction with a standard FESS. Levine HL, et al. Ann Otol Rhinol Laryngol, FESS vs balloon dilatation Retrospective comparison 70 pts with recurrent rhinosinusitis Self selected treatment, LM < FESS 35 BCD (FEDS) Friedman M, et al. Am J Rhinol,

11 Friedman M, et al. Am J Rhinol, Randomized controlled study 34 subjects with complete frontal opacification, medically refractory CRS with polyps Randomized to 2 surgical arms: Draf I and balloon dilation CT scan Lund Mckay score Patency on endoscopy Plaza G, et al. Ann Otol Rhinol Laryng, Pre operative LM score = 4 Post operative LM score = 0 Plaza G, et al. Ann Otol Rhinol Laryng,

12 80% successful dilation of frontal sinus 91% with Draf I No difference in patency rates 75-80% in both groups No major complications Plaza G, et al. Ann Otol Rhinol Laryng, Balloon catheter dilation Patency Hathorn et al patency, surgical time, and mean blood loss 30 pts CRS hybrid approach ESS then balloon dilation compared with traditional Draf IIA on the opposite side of the same patient Outcomes: All ostia remained patent, no revisions at 1 year, shorter OR time and less blood loss in hybrid approach Hathorn IF. et al. Int Forum Allergy Rhinol. 2015;5: Balloon catheter dilation The largest study to date which included inoffice BCD of the frontal sinuses in a multiinstitutional trial 251 of 268 frontal sinuses were successfully dilated (93.7%) with 5 frontal sinuses requiring revision procedures (2%) SNOT-20 and Lund-Mackay score showed significant improvement at 24 weeks (p < ) Clinically significant improvement in QOL Karanfilov B. et al. Int Forum Allergy Rhinol. 2013;3:

13 Balloon catheter dilation Revision frontal cases Small case series have shown benefit with sustained frontal sinus patency in limited follow up periods Wycherly et al reported patency in 21 of 24 frontal sinus ostia after an average of 12 months in 13 patients who underwent balloon dilation in revision frontal sinus surgery Eloy JA et al. Otolaryngol Head Neck Surg. 2012;146: Wycherly BJ et al.ann Otol Rhinol Laryngol. 2010;119: Overview History Literature review Pro-balloon data/viewpoint Contra-balloon data/viewpoint Questions 5 cadavers 9/10 accessory maxillary ostia Camera within each sinus (maxillary, frontal, sphenoid) view of ostium Balloon dilation performed by chief resident Brenner PS, et al. Int For Aller Rhinol,

14 Brenner PS, et al. Int For Aller Rhinol, Balloon Catheter Dilation Equivalent to a Draf 1 or 2? Cadaver study of 8 heads, 16 frontal sinuses Balloon catheter dilation vs Draf 1 dissection Sagittal and coronal dimensions increased significantly after BCD and Draf 1 Significantly less change noted in average coronal and sagittal dimensions in BCD compared to Draf 1. Anterior face of bulla was most frequently fractured lamella after BCD 14

15 0.8mm 1.2mm 56% of the time dilation resulted in fracture of the anterior face of the ethmoid bulla Pre dilation Post dilation with fracture of anterior ethmoid bulla Presagittal (mm) Postsagittal (mm) Presagittal (mm) Postsagittal (mm) 15

16 Balloon catheter dilation The largest study to date which included in-office BCD of the frontal sinuses in a multi-institutional trial 251 of 268 frontal sinuses were successfully dilated (93.7%) with 5 frontal sinuses requiring revision procedures (2%) SNOT-20 and Lund-Mackay score showed significant improvement at 24 weeks (p < ) Clinically significant improvement in QOL ALL AUTHORS ACLARENT CONSULTANTS AND WELL VERSED WITH BALLOONS. NOT AVERAGE ENTS Karanfilov B. et al. Int Forum Allergy Rhinol. 2013;3: Retrospective review of 1036 patients who had 3276 sinuses treated. Reinforces a favorable device safety profile. Identified 2 CSF leaks and 6 minor bleeds. All 8 cases done in conjunction with a standard FESS. Levine HL, et al. Ann Otol Rhinol Laryngol, RE Prior slide If done in conjunction with FESS, what is the advantage? Time? Cost? 16

17 PRO: Cost Friedman et al No difference in primary surgery with balloon dilation or FESS Revision surgery FESS $10,346 BCD $16,190 (shorter operative time, some inclinic) Balloon sinuplasty $1200 Lacricath $300 PRO: Cost Balloon procedures required fewer postoperative debridements than FESS or hybrid patients Balloon procedures also resulted in slightly fewer nasal endoscopies post-op This likely lowers post-op associated costs Levine et al. Annals of Otology, Rhinology & Laryngology CONTRA: Cost Difference was 1.2 debridements for FESS and 0.8 debridements for Balloon only Range 0-6 debridements! Scopes were 1.0 for FESS and 0.9 for balloons Differences pretty small, questionable savings Levine et al. Annals of Otology, Rhinology & Laryngology

18 Safety data CLEAR study- no adverse outcomes Multicenter registry- 8 complications in hybrid procedures 0.3% CSF leak rate 0.9% epistaxis MAUDE database 2 orbital injuries 2 skull base injuries Batra PS, et al. Laryngoscope, Balloon catheter dilation Safety profile: BCD generally considered safe Clinical trials: No cases of CSF leak, orbital injury, or severe epistaxis in a multi-centered trial in 115 patients and only 1 adverse event, transient periorbital swelling, reported in a similarly designed multi-institutional prospective study involving 203 patients Weiss RL, et al. Otolaryngol Head Neck Surg, Karanfilov B. et al. Int Forum Allergy Rhinol. 2013;3: Balloon catheter dilation Safety profile: Real world cases: Open FDA database reporting 114 adverse events over an 8 year time period in a study by Prince and Bhattacharyya, there were 17 skull base injuries, 15 of which had a CSF leak Balloon dilation of the frontal sinuses significantly associated with these injuries The difference underscores the importance of patient selection and the surgeon s experience Prince A et al. Otolaryngol Head Neck Surg 2016;154:

19 ARS statement on BCT Acceptable and safe for use Tool, not a procedure Concurrent convention FESS may be needed In select patients it may be used alone It is not investigational or experimental Balloon catheter dilation Conclusions Equivocal patency results of balloon dilation compared to standard ESS in the cohorts studied Efficacy and feasibility not the same across the wide range of severities and rhinosinusitis subtypes 29 Controversial among rhinologists and otolaryngologists Mild to moderately severe disease and in select revision cases, the balloon appears to be a safe and effective instrument and does not preclude endoscopic surgery in the future Discussion Good safety profile Lack of comparative studies One randomized trial to date- comparable to FESS Appropriate indications or guidelines have not been developed Single arm studies- unclear selection criteria Who is this tool best for? 19

20 Summary Do Consider using balloon dilation for appropriate patients Consent patients for complications Summary Do not: Consider balloon dilation a universal option Assume balloon dilation does not carry risk 20