Balloon Sinuplasty

TITLE: Balloon Sin= uplasty
SOURCE: Grand Rounds Presentation, UTMB, Dept. of Otolaryngology
DATE: December 16, 2009
RESIDENT PHYSICIAN:Ki-Hong Kevin Ho, MD
FACULTY PHYSICIAN: Patricia Maeso, MD
SERIES EDITORS: Francis B. Quinn, Jr., MD
ARCHIVIST: Melinda Stoner Qui= nn, MS(ICS)

"This material was prepared by resident physicians in partial fulfillment of educational requirements established for the Postgraduate Training Program of the UTMB Department of Otolaryngology/Head= and Neck Surgery and was not intended for clinical use in its present form. It = was prepared for the purpose of stimulating group discussion in a conference setting. No warranties, either express or implie= d, are made with respect to its accuracy, completeness, or timeliness. The materia= l does not necessarily reflect the current or past opinions of members of the UTMB faculty and should not be used for purposes of diagnosis or treatment witho= ut consulting appropriate literature sources and informed professional opinion."

Introduction

Millions of Americans suffer from sinusitis each= year. Functional endoscopic sinus surgery (FESS) has transformed the field of Rhinology and how we treat sinus disease in the past = few decades. This is attributed to several pioneers who laid the foundation for= the popularity of FESS. Towards the end of the nineteenth century, George Caldwell and Henri Luc published = the canine fossa approach to the maxillary sinus. <= span class=3DSpellE>Hirshman was the first to describe the use of nasal endoscopy in 1901 through modifying a cystoscope. The Hopkins= rod telescope was developed and patented in 1960, greatly enhancing the visualization of nasal cavity. In 1978, Messerklinger<= /span> documented his endoscopic experience with a collection of images. In the mid-1980s, Stammberger published a series of pape= rs describing endoscopic sinus surgery techniques. Later, Kennedy and colleagues brought these techniques t= o the United States and coined the term ‘‘functional endoscopic sinus surgery.’’

The concept of balloon sinu= plasty stemmed from the success of similar balloon devices employed in other specialties such as cardiology, urology, GI, and vascular surgery. The idea= of mucosal preservation in balloon sinuplasty is appealing for its potential to minimize scarring and re-stenosis of dilated sinus ostium. Whether balloon sinuplasty will be as popular as angioplasty remains = to be seen, but there is no question this technology has gained significant momen= tum within our specialty in the past few years.

American Rhinology Socie= ty statement on balloon sinuplasty (2006):

- &nb= sp; Balloon dilation technology may have potential application where surgical managemen= t of sinus disease is required.

- &nb= sp; The technology has limited surgical indications at this time.=

- &nb= sp; Patients treated with balloon dilation may still require conventional sinus surgery.=

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

How it works:

A catheter is first introduced near the natural = ostium of a sinus, for instance, behind the uncinate for the maxillary sinus. A guidewire is then passed through this catheter to enter into the sinus. The wire should never be pushed ag= ainst any resistance. Once the guidewire passes easil= y into the sinus, its location is confirmed by either fluoroscopy with a c-arm or = transillumination with the new LUMA illumination guidewire. Friedman compared fluoroscopy and LUMA and reported that the successes of cannulation were similar. Once the guidewire is confirmed to be = within the sinus, the tip of the guide catheter is held outside of the sinus (confirmed by endoscopic visualization). The white band on the proximal end= of the balloon is fully inserted into the guide catheter. This advances the balloon into the sinus so that t= he distal end of the balloon is just out of the guide catheter. This is confir= med endoscopically by visualizing the yellow marking on t= he balloon that indicates it has exited the distal tip of the guide catheter The technique then is standard, in that the balloon is inflated, deflated, and = then removed.

Initial feasibility studies:

Bolger performed an initial feasibility study on= 6 cadaver heads in 2006. Balloon dilation was successful in all 31 sinuses (9 maxillary, 11 sphenoid, 11 frontal). Postoperative CT scan showed microfracture of ostia sites without injury to orbit or skull base. Brown performed a prospective non-randomized cohort on 10 patients and showed that dilation was easiest w= ith sphenoid sinus, followed by frontal and maxillary sinuses. There was mild d= ifficulty in dilating 5 of 10 maxillary sinuses. There was again no complication or adverse events associated with balloon dilation.

The CLEAR study:

Arguably the most comprehension study for balloo= n sinuplasty to-date, the CLEAR study is a multi-center= , prospective non-randomized study published in 3 parts, starting with a 24-week data, followed by 1-year and 2-year data. The 2 study groups consisted of patients who underwent hybrid procedures (FESS plus balloon) and those who just had balloon sinuplasty. The study did not compare t= he two groups directly, but rather the preoperative and post-operative SNOT-20 sco= res, Lund-Mackay scores, and ostia patency based on = nasal endoscopy for each group.

The following patient selection criteria were us= ed:

Inclusion criteria:

} Adult > age of 18 years

} Chronic sinusitis unresponsive to medical management

Exclusion criteria:

} Extensive sinonasal polyps, cystic fibrosis

} Extensive previous sinonasal surgery

} Extensive sinonasal osteoneogenesis<= /span>

} Sinonasal tumors,

} History of facial trauma

} Ciliary dysfunction

} Pregnancy

For SNOT-20 results, there was significant impro= vement of patient symptoms between preop and postop for each group. The differences between 24-wee= k, 1-year, and 2-year data were not significant. Weiss et al reported that the most improved symptom was facial pain/pressure relief. Similarly, Lund-Mack= ay scores showed significant improvement of CT findings between preop and both 1-year and 2-year data, and no differe= nce between 1-year and 2-year data.

The overall ostia pa= tency rate was 85% (172/202 sinuses) at 1 year postop= . For the indeterminant ostia (obscured by uncinate and = ethmoid that were left intact for balloon sinuplasty), = their corresponding CT scans were reviewed to evaluate ostia= patency. Taken the CT findings into account, the overall patency rate was 9= 1.6% (185/202 sinuses), with maxillary sinus having the highest patency rate (93= .5%) and sphenoid the lowest (86.1%). There were no adverse events such as CSF l= eak or orbital injury reported.

Pediatric population:

Ramadan reported in a prospective study of 30 ch= ildren that balloon dilation was successful in 51/56 sinuses from pediatric patien= ts suffering from chronic sinusitis (excluding cystic fibrosis, immunodeficient, cilliary= dysmotility patients). Of the 5 sinuses that failed b= alloon dilation, 4 were hypoplastic maxillary sinuses = and 1 was frontal sinus. There was no complication reported. No information on quality of life was reported in this study.

Radiation exposure:

Radia= tion exposure during fluoroscopy carries the risk of cataract formation. = The International Commission on Radiological Protection has stated that acute d= oses of 2 Gy may cause cataract formation. It has also been reported that an a= verage of 4.2 mGy per eye in balloon sinuplasty, which is much less than the cataract threshold. The new Luma illumination system provides an alternative to identify sinus location and avoids the potential complications with radiation exposure.

Future directions:

Balloon sinuplasty p= rovides a new armamentarium for otolaryngologists to treat sinus disease. According= to Dr. Raymond Weiss, “sinuplasty is a new technique in performing endoscopic sinus surgery—not a new procedure = but rather a new tool that further reduces mucosal damage and advance us toward= our ultimate goal of improving function with maximal mucosal preservation”= ;. It has been recently reported that balloon sinuplasty<= /span> can be safely and successfully performed under local anesthesia in the BREATHE-1 trial. While it holds great promise for office-based sinus proced= ures, further study is needed to better define its role in the surgical managemen= t of chronic sinusitis especially with regard to patient selection and disease t= ypes best suited for this technology.

References:

1. Messerklinger W. Endoscopy of t= he nose. Baltimore (MD): Urban & Schwarzenberg; 1978.

2. Stammberger H. Nasal and pa= ranasal sinus endoscopy: a diagnostic and surgical approach to recurrent sinusitis. Endoscopy 1986;18(6):213–8.

3. Kennedy DW, Zinrich SJ, Rosenbaum AE, et al. Functional endoscopic sinus surgery. Theory and diagnostic evaluation. Arch Otolaryngol 1985;111(9):57= 6–82.

4. Brown = CL, Bolger WE. Safety and feasibility of balloon catheter dilation of paranasal sinus ostia: a preliminary investigation. Ann Otol Rhinol Laryngol 2006;115(4):293–9.

5. Friedm= an A, Schalch P, Lin SC, et al. Functional endoscopic dilat= ation of the sinuses: patient satisfaction, postoperative pain, and cost. Am J Rhinol 2008; 22:204–9.

6. Bolger= WE, Vaughan W. Catheter based dilation of the sinus ostia<= /span>: initial safety and feasibility in a cadaver model. Am J Rhinol 2006;20(6):290–4.

7. Bolger= WE, Brown CL, Church CA, et al. Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 pat= ients. Otolaryngol Head Neck Surg= 2007;137:10–20.

8. Kuhn F= A, Church CA, Goldberg AN, et al. Balloon catheter sinuso= tomy: one-year follow-up—outcomes and role in functional endoscopic sinus surgery. Otolaryngol Head Neck Surg 2008;139:S27–37.

9. Weiss RL, Church CA, Kuhn FA, et al. Long-term analysis of bal= loon catheter sinusotomy: two-year follow-up. Otolaryngol Head Neck Surg 2008;138:S38–46.

10. Levine H, Sertich AP, Hoisington D= R, et al. Multicenter registry of balloon catheter sinusotom= y outcomes for 1036 patients. Ann Otol Rhinol Laryngol 2008;117(4):265–70.

11. Church CA, Kuhn FA, Mikhail J, et al. Patient and surgeon radiation exposure in balloon catheter sinus ostial dilation. OtolaryngolHeadNeckSurg 2008;138:= 187–91.

12. Vaughan WC. Review of balloon sinuplasty. Curr Opin Otolaryngol He= ad Neck Surg 2008;16:2–9.

13. Stankiewicz J, Tami T, Truitt T, et al. Transantral, endoscopically guided balloon dilatation of the ostiomeatal co= mplex for chronic rhinosinusitis under local anesthes= ia. Am J Rhinol Allergy 2009;23:1<= /span>–7.

14. Friedman M, Wilson M. Illumination guided balloon sinuplasty. Laryngoscope. 2009 Jul;119(7):1399-402.