Safety and outcomes of balloon catheter sinusotomy: A ... · ORIGINAL RESEARCH Safety and outcomes...

Otolaryngology–Head and Neck Surgery (2007) 137, 10-20

ORIGINAL RESEARCH

Safety and outcomes of balloon catheter sinusotomy:

A multicenter 24-week analysis in 115 patients

William E. Bolger, MD, Christopher L. Brown, MD,Christopher A. Church, MD, Andrew N. Goldberg, MD, MSCE,Boris Karanfilov, MD, Frederick A. Kuhn, MD, Howard L. Levine, MD,Michael J. Sillers, MD, Winston C. Vaughan, MD, andRaymond L. Weiss, MD, Bethesda, MD; Melbourne, Australia; Loma Linda, CA;San Francisco, CA; Columbus, OH; Savannah, GA; Cleveland, OH; Birmingham, AL;
Palo Alto, CA; and Biloxi, MS
OBJECTIVE: The aim of this study was to further evaluate thesafety and effectiveness of balloon catheter devices to dilate ob-structed sinus ostia/perform sinusotomy.METHODS: Through a prospective, multicenter evaluation,safety was assessed by rate of adverse events, patency was deter-mined by endoscopic examination, and sinus symptoms were de-termined by the Sino-Nasal Outcome Test (SNOT 20).RESULTS: At the conclusion of the 24-week analysis, endoscopydetermined that the sinusotomy was patent in 80.5% (247 of 307) sinusesand nonpatent in 1.6% (5 of 307), and could not determine ostial patencystatus in 17.9% (55 of 307). Of the ostia visualized on endoscopy, 98%were patent (247 of 252), while 2% (5 of 252) were considered nonpatent.SNOT 20 scores showed consistent symptomatic improvement overbaseline. Revision treatment was required in 3 sinuses (3 of 307 sinuses,0.98%) in 3 patients (3 of 109 patients, 2.75%).CONCLUSION: Balloon catheter technology appears safe andeffective in relieving ostial obstruction. Patients were pleased andindicated that they experienced symptomatic improvement.© 2007 American Academy of Otolaryngology–Head and NeckSurgery Foundation. All rights reserved.

Sinus surgery has evolved significantly over the past 2decades. Endoscopic surgery represents a major inno-

vation that avoids facial incisions. Thru-cutting forceps andtissue microdebrider devices spare mucosa and improvehealing. Despite these advances, problems such as bleeding,scarring, and orbital or intracranial entry still occur.

A catheter-based approach was introduced to reduce mu-cosal trauma, scarring, bleeding and associated sequelae.This innovative concept was prompted by the success ofcatheter technology in other medical disciplines includingcardiology, urology, gastroenterology, and vascular sur-gery.1-4 Preliminary studies indicate that catheter devices

Received September 1, 2006; accepted February 8, 2007.

0194-5998/$32.00 © 2007 American Academy of Otolaryngology–Head and Necdoi:10.1016/j.otohns.2007.02.006

developed specifically for the sinuses can safely dilate sinusostia and relieve sinus ostial obstruction.5,6

These initial results in a small number of patientsprompted us to study a larger number of patients, over alonger period of time. The objectives of this investigationwere 1) to evaluate the effectiveness of balloon catheterdevices in relieving sinus ostial obstruction and in main-taining sinus ostia patency; 2) to confirm the safety ofsinusotomy using balloon catheters in a larger patient group,and 3) to gain insight into the ability of sinusotomy withballoon catheters to relieve sinus symptoms, either alone orin combination with standard endoscopic sinus surgerytechniques.

METHODS

A multicenter, prospective evaluation of sinusotomy usingballoon catheter devices was conducted in patients withsinusitis for whom endoscopic sinus surgery was recom-mended. Local institutional review boards at each study siteapproved the study, and regulations regarding human sub-jects research and safeguarding of confidential patient datawere followed.

Inclusion criteria included age of 18 years or greater,diagnosis of chronic sinusitis unresponsive to medical man-agement, and planned endoscopic sinus surgery. Exclusioncriteria included extensive sinonasal polyps, extensive pre-vious sinonasal surgery, extensive sinonasal osteoneogen-esis, cystic fibrosis, sinonasal tumors, history of facialtrauma that distorted sinus anatomy, ciliary dysfunction,and pregnancy. Consecutive patients who met these criteriawere offered study participation by the study site investiga-tor from April 15, 2005 through December 23, 2005.

k Surgery Foundation. All rights reserved.

11Bolger et al Safety and outcomes of balloon catheter sinusotomy . . .

Patients received a thorough preoperative evaluation forsinusitis, including clinical history, physical examination, si-nonasal endoscopy, paranasal sinus computed tomographic(CT) scan, and Sino-Nasal Outcome Test (SNOT 20).7 Inves-tigators selected which sinus would receive sinusotomy usingthe balloon catheter device on the basis of the patient’s diseasepattern (Fig 1A and B). Preoperative medical management wasdetermined by the individual investigator. Preoperative CTscans were scored by the investigators using the Lund-MacKay

Figure 1 (A) Endoscopic view of patient with chronic maxil-lary sinus symptoms not responsive to medical management. (B)Coronal sinus CT of patient in 1A; the right maxillary sinusitis isopacified.

radiographic staging system.8

Investigators prepared patients for surgery in the samefashion as for endoscopic sinus surgery. In addition tostandard endoscopic sinus surgery equipment, a C-arm flu-oroscope was utilized. The patient, investigators, and oper-ating room staff wore appropriate radiological shields.Catheter devices used in this investigation included sinus-guiding catheters, sinus guide wires, and sinus balloon cath-eters (Acclarent Inc, Menlo Park, CA). The guide catheterwas introduced into the nasal cavity under endoscopic vi-sualization and placed adjacent to the obstructed maxillary,sphenoid, or frontal ostium/recess (Fig 2). Thereafter, the sinuswas catheterized and dilated under fluoroscopic control withthe use of a 5-, 6-, or 7-mm balloon catheter (Fig 3). Afterdilation, the tissues were inspected endoscopically (Fig 4). Ifindicated, the sinus was irrigated with the use of a sinus lavagecatheter. If the investigator was unable to cannulize an ostiumor if the balloon catheter did not appear to sufficiently open anostium, a standard endoscopic surgical technique was used andnoted. Fluoroscopy time was recorded. Intra-, peri-, or postop-erative adverse events were recorded.

Standard endoscopic sinus surgery postoperative carewas provided. Study evaluation and data were collected atvisits 1-2, 12, and 24 weeks after the procedure. Postoper-ative visits included interval history, endoscopic examina-tion, SNOT 20, and a standardized patient questionnaireregarding postoperative change in symptoms. The investi-gator recorded the status of each balloon-treated sinus os-tium as either patent, not patent, or indeterminate on endo-scopic examination. “Indeterminate” was used if the ostiumcould not be viewed in the postprocedure setting with rigid

Figure 2 Endoscopic placement of the guiding catheter at the
hiatus semilunaris.

12 Otolaryngology–Head and Neck Surgery, Vol 137, No 1, July 2007

endoscopy or if the patient did not tolerate a completeendoscopic examination.

The investigators attempted to estimate final ostial sizewhen possible, by placing a suction aspirator of known sizethrough the ostium. Estimating the final size of the ostiumwas not a primary, but a secondary, study end point.

During the investigation, one author (W.E.B.) did nottreat patients but served as a medical monitor, responding topatient safety issues and overseeing data from the variousstudy sites. An independent statistician conducted statisticalanalysis.

In completing the SNOT 20, patients were asked torate the severity of 20 symptoms over the preceding 2weeks, on a 6-point scale from 0 � “no problem” to 5 �“problem as bad as it can be.” For each patient at eachvisit, the mean of the rated symptoms was calculated andcompared with baseline. If a patient neglected to ratemore than five of the symptoms at a particular visit, thatvisit’s test was not used. Statistical significance of themean change from baseline for all treated patients and forthose treated with balloon catheter alone was determinedwith the paired t test and confirmed by the Wilcoxonsigned rank test.

At weeks 1, 12, and 24, patients used a structuredquestionnaire to rate their sinusitis symptoms comparedwith those before treatment on a 5-point scale: signifi-cantly improved � 2, improved � 1, same � 0, worse ��1, significantly worse � �2. The mean scores weresummarized by visit for all study patients and for thosetreated only with balloon catheters. The percent of pa-tients reporting improvement (scores of 1 or 2) were

Figure 3 Fluoroscopic view of the inflated balloon across theostium.

presented.

RESULTS

The investigators offered enrollment to 115 patients (41 male,74 female) and all elected to participate in the study. Theaverage age was 47.8 years (range 21-76 years). Twenty-onepatients had a history of previous endoscopic sinus surgery(18.3%).

From the initial study population of 115 patients, a co-hort of 109 patients was followed. Six patients did notcontinue in the study. Three patients had scarring fromprevious endoscopic sinus surgery precluding access; in twopatients, the surgeon thought the frontal balloon sinusotomywas insufficient; and in the remaining patient, polyps pre-vented access to the sinus. The surgeon converted thesepatients to an endoscopic dissection with traditional instru-mentation, thereby exiting these six patients from the study.Radiographic analysis of enrolled patients revealed an over-all Lund-MacKay CT scan mean score of 8.33 with a rangeof 1 to 21 (Table 1).

Sinusotomy using balloon catheter devices was at-tempted in 358 sinuses. Devices cannulated 347 of 358(96.9%) sinus ostia attempted. Cannulation was not possiblein six sinuses because of scar tissue from previous surgery,anatomic restrictions in four sinuses, and polypoid mucosaedema in one sinus. In five sinuses, cannulation and dilationwere accomplished; however, the surgeon believed theopening was insufficient and opened the sinus further withendoscopic cutting instrumentation.

Sinusotomy using balloon catheters was successfullyperformed in 143 maxillary ostia, 75 sphenoid ostia, and124 frontal recesses. An average of 3.1 sinuses per patientwas treated with the balloon catheter devices.

In 57 of 109 patients (52.3%), sinusotomy using ballooncatheters was performed in at least one sinus during surgery

Figure 4 Endoscopic view of ostium immediately after ballooncatheter dilation. A suction catheter is placed to allow placement ofthe endoscope and to reference ostial size. Erythematous andedematous mucosa and purulence are evident within the maxillary
sinus.


in which traditional endoscopic instrumentation was used totreat other sinuses. Sinusotomy using balloon catheters wasthe only sinus intervention in 52 of 109 patients, (47.7%).

There were no serious adverse events. No patient expe-rienced cerebrospinal fluid leak, orbital injury, or nasalbleeding that required packing. There were nine cases ofbacterial sinusitis postdilation that resolved with oral anti-biotic treatment.

The median fluoroscopy time per sinus was 0.81 min-utes; the average radiation dose per patient was approxi-mately 730 mrem.

Devices malfunctioned in 12 of 358 applications/sinuses.In seven cases, the balloon ruptured; in four cases, thecatheter tip malfunctioned when it kinked or the guidebecame obstructed with tissue; and in one case, the balloondevice deflated slowly.

Follow-up examination was conducted in 108 patients(341 sinuses) at 1 week; one patient (one sinus) missed thisvisit. Endoscopy revealed the dilated sinus ostia to be patentin 232 sinuses, nonpatent in seven sinuses, and indetermi-nate in 102 sinuses.

In the subsequent weeks, one patient (one sinus) left thestudy to pursue treatment of a newly diagnosed unrelatedcancer. Another patient, with a nonpatent sinus, underwentrevision treatment of the dilated sinus as indicated by thepatient’s clinical course.

Of the 107 patients (340 sinuses) continuing in the study, 90patients (268 sinuses) were evaluated at the 12-week follow-upexamination. Thirteen patients (55 sinuses) missed the visit,four patients (15 sinuses) were permanently lost to follow-up,and data were not recorded for two sinuses. (Note: One of thestudy sites was located in Biloxi, MS, where eight patients (36sinuses) missed visits and were lost to follow-up at the time ofHurricane Katrina.) Endoscopic examination of the 268 si-nuses available at the 12-week follow-up visit revealed 212patent sinus ostia, 6 nonpatent sinuses, and indeterminate pa-tency in 50 sinuses.

In the weeks immediately after the 12-week examination,two sinuses were revised in two patients because theirclinical course indicated a revision treatment was needed.

Of the 103 patients (323 sinuses) continuing in the study,95 patients (304 sinuses) completed the 24-week follow-upexamination. Eight patients (19 sinuses) were lost to follow-

Table 1

Summary of preoperative Lund-MacKay CT scan stagin

All patients enrolledBalloon catheter si

surgn � 115

Mean 8.33Range 1-21

CT, computed tomography.

up. At 24 weeks, endoscopic examination revealed 247

patent sinuses, two nonpatent sinuses, and indeterminatepatency in 55 sinuses.

Over the entire study, postdilation endoscopy revealednonpatency in 5 sinuses that was irreversible or progressedto revision surgery. Two sinuses remained nonpatent at theend of the study but were not symptomatic, while threenonpatent sinuses were symptomatic and treated with addi-tional measures to reestablish patency during the course ofthe investigation. (Note: Nonpatency due to temporaryedema or inflammation eventually reversed, making nonpa-tency a dynamic marker.) Analysis of the three symptomaticnonpatent sinuses (three patients) revealed the followingfindings. One patient was symptomatic and judged to havea nonpatent maxillary sinus on endoscopic evaluation ap-proximately 5 weeks after balloon catheter sinusotomy. Itappeared the nonpatency was due to edema. The surgeonelected to perform a limited endoscopic procedure to openthe maxillary ostium. During this revision procedure usingtraditional endoscopic cutting instruments, the infundibu-lum showed significant edema, but on resecting the uncinateprocess, the ostium was noted to be open and approximately3 mm in size. The patient’s symptoms improved after theendoscopic antrostomy. Another patient had a nonpatentmaxillary sinus attributable to stenosis and was asymptom-atic, but the sinus was totally opacified on follow-up CT scan.The surgeon and patient elected revision sinusotomy using theballoon catheter devices, and a successful result was achieved.The third patient had a nonpatent frontal sinus attributable toedema and was symptomatic. The surgeon elected to performrepeat sinusotomy using the balloon catheter devices andachieved a successful result. Even though these 2 patientsultimately achieved successful sinusotomy with balloon cath-eters, we considered these cases failures for purposes of eval-uating the primary balloon interventions in the study cohort.

To summarize, endoscopy demonstrated patency in80.5% (247 of 307) and nonpatency in 1.6% (5 of 307),and could not ascertain whether a sinus was patent ornonpatent in 17.9% (55 of 307). For those ostia that wereobserved with endoscopy, the patency rate was 98% (247of 252). Revision treatment was required in 3 sinuses (3of 307 sinuses, 0.98%) in 3 patients (3 of 109 patients,2.75%). Patency results are reported by individual si-nuses in Table 2.

Patient symptoms improved as demonstrated by SNOT 20

res

omy with concurrent endoscopict different sinuses

Balloon cathetersinusotomy only

n � 59 n � 56

10.4 6.11-21 1-17

g sco

nusotery a

scores. For the overall study group, the mean score improved


from 2.25 before sinusotomy (n � 106, SD � 1.08) to 1.39at 1 week (n � 106, SD � 0.95), 1.07 at 12 weeks (n � 92,SD � 0.92), and 1.09 at 24 weeks (n � 94, SD � 0.99) aftersinusotomy. The change from baseline was �0.84 at 1 week(SE � 0.10), �1.25 at 12 weeks (SE � 0.11), and �1.17 at24 weeks (SE � 0.13); all changes were statistically signif-icant (P value � 0.0001). Patients treated with ballooncatheter sinusotomy in 1 or more sinuses but also treatedwith endoscopic instrumentation in different sinuses expe-rienced symptomatic improvement from a mean score of2.37 before treatment (n � 57, SD � 1.16) to 1.57 at 1 week(n � 57, SD � 1.04), 0.99 at 12 weeks (n � 50, SD � 0.88),and 0.98 at 24 weeks (n � 52, SD � 0.94) after sinusotomy.The change from baseline was �0.80 at 1 week (SE �0.16), �1.45 at 12 weeks (SE � 0.16), and �1.37 at 24weeks (SE � 0.19); all changes were statistically significant(P value � 0.0001). Patients treated with balloon cathetertechnology alone also experienced symptomatic improve-ment from a mean score of 2.10 before sinusotomy (n � 49,SD � 0.97) to 1.17 at 1 week (n � 49, SD � 0.79), 1.16 at

Table 2

Summary of ostia patency on sinonasal endoscopy

Maxillary Sphenoid Frontal

Postoperativeweek 1 total 142 75 124

Patent 106 (75%) 41 (55%) 85 (69%)Nonpatent 0 0 7 (6%)Indeterminate 36 (25%) 34 (45%) 32 (26%)


Patent 98 (84%) 32 (59%) 82 (84%)Nonpatent 3 (3%) 0 3 (3%)Indeterminate 15 (13%) 22 (41%) 13 (13%)


Patent 113 (91%) 40 (61%) 94 (82%)Nonpatent 1 (1%) 0 1 (1%)Indeterminate 10 (8%) 26 (39%) 19 (17%)

Table 3

Mean SNOT 20 scores before and after sinusotomy us

All patients treated

Week N Mean� from

baseline P value

Preoperative baseline 84 2.30 — —Postoperative week 1 84 1.48 �0.82 �0.0001Postoperative week 12 84 1.02 �1.28 �0.0001Postoperative week 24 84 1.13 �1.17 �0.0001

Note: Results shown for patients who completed SNOT 20

12 weeks (n � 42, SD � 0.96), and 1.22 at 24 weeks (n �42, SD � 1.05) after sinusotomy. The change from baselinewas �0.89 at 1 week (SE � 0.11), �1.01 at 12 weeks(SE � 0.12), and �0.91 at 24 weeks (SE � 0.17); allchanges were statistically significant (P value � 0.0001).There were 84 patients in the overall study group whocompleted the SNOT 20 at the baseline, 1-week, 12-week,and 24-week encounters (all encounters, complete data set).Their data are presented in Table 3 and are similar to theoverall study cohort, but eliminate the possibility that thechange from baseline might be attributed to differences inthe number of subjects completing the SNOT 20 at thedifferent study time points.

The structured patient questionnaire regarding change insinusitis symptoms compared with those before ballooncatheter sinusotomy revealed improvement. For the overallstudy group, the percentage of study patients who reportedthat their symptoms improved (score of 1 or 2) was 83% (86of 104) at 1 week, 96% (87 of 91) at 12 weeks, and 84% (80of 95) at 24 weeks. For patients who underwent ballooncatheter sinusotomy but also had endoscopic sinus surgeryat a different sinus, symptoms were improved in 80% (45 of56) at 1 week, 94% (46 of 49) at 12 weeks, and 88% (45 of51) at 24 weeks. Among patients treated with balloon cath-eter devices alone, symptoms were improved in 85% (41 of48) at 1 week, 98% (41 of 42) at 12 weeks, and 80% (35 of44) at 24 weeks (Table 4).

DISCUSSION

This study confirms preliminary results on the safety andfeasibility of using balloon catheter technology to performsinusotomy. In this expanded group of patients, investiga-tors had a high success rate in locating, cannulating, anddilating sinus ostia. Balloon catheter devices permitted asafe sinusotomy that was “durable” because patency ratesremained high over time. Serious adverse events related tothe sinus balloon catheter devices did not occur. There wereno incidents of cerebrospinal fluid leak, diplopia, visual

lloon catheter devices

n catheter sinusotomyconcurrent endoscopicery at different sinuses

Balloon catheter sinusotomyonly

ean� from

baseline P value N Mean� from

baseline P value

.42 — — 36 2.14 — —

.64 �0.78 �0.0001 36 1.27 �0.87 �0.0001

.98 �1.44 �0.0001 36 1.08 �1.06 �0.0001

.02 �1.40 �0.0001 36 1.27 �0.87 �0.0001

visits: baseline, and follow-up at 1, 12, and 24 weeks.

ing ba

Balloowithsurg

N M

48 248 148 048 1

at all


loss, or significant intraoperative bleeding. Stenosis of di-lated ostia occurred infrequently.

The sinusotomy achieved with balloon catheter devicesis durable (maintained over time). In this study, ostia wereobserved for 24 weeks after treatment for evidence of ostialstenosis to encompass the typical wound-healing processbeyond the time that collagen remodeling levels off (ap-proximately 3-4 months after tissue injury).9,10 Our obser-vations indicate that the tissue-healing dynamics for ballooncatheters used in the paranasal sinuses differ from thosedescribed in circumferential soft tissue structures such asblood vessels or ureters. In blood vessels, circumferential bal-loon catheter dilation has been associated with circumferentialscarring, leading to stenosis. In the sinuses, we observed thatbony sinus structures were displaced or molded and tended tomaintain their displaced position. We observed circumferentialscarring with stenosis infrequently.

A key consideration for surgeons adopting a new tech-nology is the ability to achieve good results without intro-ducing new complications. It is well-documented that com-plications occur more frequently during the initial adoptionperiod for new technologies.11-15 This study indicates thatthe “learning curve” for balloon catheter technology is notsteep, and serious complications do not appear to accom-pany initial adoption.

Study patients indicated they experienced a significantlevel of symptomatic improvement. A validated quality oflife instrument, the SNOT 20, and a structured patient ques-tionnaire provided insight into patient outcome and patientsatisfaction. This information answered the basic questionspracticing otolaryngologists have when considering a newtechnology for use in their patients: “Does it do what it saysit will do? Is it safe? Will my patients feel better?” Thesedata expand the knowledge base regarding the catheter-based approach and rhinology in general.

Performing sinusotomy with balloon catheter devicespresently requires fluoroscopy. Although steps can be takento reduce radiation exposure, a small risk remains. Theaverage radiation dose to study patients was approximately730 mrem. This dose compares with a head CT scan (200

Table 4

Patients reporting improved sinusitis symptoms after

Week

All patients treated

N % Improved

Postoperative week 1 86/104 83%Postoperative week 12 87/91 96%Postoperative week 24 80/95 84%

N � number of patients reporting improvement over the n

mrem),16 chest CT (800 mrem),16 and angioplasty (750-

5700 mrem).17 Although radiation exposure to the patient isbrief, cumulative exposure to surgeons deserves specialconsideration. Special measures such as radioprotectivegloves (Aadco Medical Inc, Randolph, VT) and dosimetryrings (Radiation Detection Co, Gilroy, CA) are prudentmeasures.

Case selection is an important consideration in forming astudy cohort. Our study enrolled patients who failed medi-cal therapy and were recommended for endoscopic sinussurgery. Once the recommendation for endoscopic sinussurgery was rendered, the patients were offered the oppor-tunity to participate in the investigation. Therefore, thepatients included in this study fit surgeon-determined crite-ria for endoscopic sinus surgery as practiced in the UnitedStates and Australia. Study exclusion criteria excluded pa-tients with sinonasal polyposis and extensive previous sur-gery. Therefore, the study population represents a subset ofpatients with disease significant enough to warrant standardendoscopic sinus surgery. It is important to point out that inthis study investigators were largely studying the perfor-mance of a device in performing sinusotomy of obstructedostia. In future studies that seek to compare the effective-ness of balloon catheter devices with other instrumentationor surgical techniques in treating chronic sinusitis, standard-ized case definitions of chronic sinusitis would have to beused to ensure that each study group was composed ofsimilar patients.

Another important consideration in the study cohort isthe use of standardized CT scan staging systems. Thesesystems have limitations both in staging chronic rhinosinus-itis and in evaluating a new therapeutic intervention. Theyoften correlate poorly with clinical symptoms, and valida-tion has not been possible because chronic sinusitis ispoorly defined and can arise from several different patho-physiologic processes. To the best of our knowledge, thesestaging systems have no previous application in deviceperformance studies. Further, the ability of any CT stagingsystem to characterize a cohort of study patients in terms ofappropriateness of an intervention has not been determined.Appropriateness for intervention is more complex and re-

tomy using balloon catheter devices

Balloon cathetersinusotomy with

concurrent endoscopicsurgery at different

sinusesBalloon cathetersinusotomy only

N % Improved N % Improved

45/56 80% 41/48 85%46/49 94% 41/42 98%45/51 88% 35/44 80%

r of patients responding to the structured questionnaire.

sinuso

umbe

quires an appreciation of symptoms, symptom burden, pre-


vious attempted treatments, pathophysiologic mechanism ofa given patient’s sinus disease, and the treatment underconsideration, not CT scan score alone. In our study, weelected to rely on the clinical judgment of seasoned, highlytrained rhinologists, rather than a “standardized” CT scoringsystem. We include results from the widely accepted Lund-MacKay system so that the reader can gain insight into theradiographic profile of our study population. The ballooncatheter devices are not used in the ethmoid sinus; therefore,it logically follows that patients treated with only ballooncatheter devices will have a lower Lund-MacKay scorebecause the ethmoids are heavily weighted in the Lund-MacKay system.

Another consideration in the research cohort is the base-line level of preoperative symptoms and how these arereported. Results from the SNOT 20 can be reported in 1 of2 ways: as a mean score (maximum of 5.0) or a sum score(maximum of 100). We reported the mean SNOT 20 scoreas suggested by the independent validation paper of Piccir-illo et al.7 The mean preoperative SNOT 20 score in ourstudy was 2.25; the corresponding preoperative sum scorewas 45.0. In Piccirillo’s original paper, the mean SNOT 20score was 1.9. His study cohort was made up of adultpatients with signs and symptoms suggestive of rhinosinus-itis who presented to his clinic. It is not surprising that ourmean score was higher at 2.25 because our study populationwas made up of patients for whom endoscopic sinus surgerywas recommended. In another study, Jones et al18 reportedSNOT 20 scores in patients undergoing endoscopic sinussurgery and represented their results as a sum score of43.31, similar to our patient’s sum score of 45. Because ourstudy inclusion criteria allowed enrollment of patients forwhom only endoscopic sinus surgery was recommended, itis not surprising that our patients reported a symptom levelconsistent with that previously reported in the literature forpreoperative endoscopic sinus surgery patients.

In this study, investigators became aware of the challengesin using rigid sinonasal endoscopy to confirm ostial patencyafter balloon catheter sinusotomy. In cases in which concom-itant endoscopic ethmoidectomy was not performed, residualethmoid tissue restricted endoscopic examination. Some pa-tients did not tolerate rigid endoscopy of narrow sinus spacessuch as the sphenoethmoid recess. If an ostium was not visu-alized on endoscopic examination, we could not confirm itspatency and designated it as “indeterminate.” In this situation,it was not known if the ostium was patent or nonpatent, and itwould be inappropriate to consider all indeterminate sinuses asnonpatent (or as patent). Undoubtedly, many rhinologists havehad the experience of evaluating a patient months after endo-scopic sinus surgery and discovering the middle turbinate lat-eralized against the lamina orbitalis, precluding endoscopicvisualization of the maxillary sinus ostium/antrostomy or fron-tal sinusotomy. Medialization of the turbinate often (but not inall cases) reveals an open sinus. With more experience andfurther study, we will be able to ascertain how many of the
indeterminate sinus ostia are ultimately determined to be patent
vs nonpatent and if outcomes are significantly different forpatients with indeterminate sinus ostia. This is an importantarea for additional investigation in catheter-based treatment.Innovation and design of a new generation of smaller endo-scopes with better steering capability could facilitate patientfollow-up examination and clinical research in patients afterballoon catheter sinusotomy.

Although our primary end point was ostial patency vsnonpatency, investigators tried to estimate sinusotomy sizeon postoperative endoscopy as a secondary study end point.The increased tissue preserved during sinusotomy usingballoon catheter devices restricted endoscopy and accurate,consistent measuring across study sites. Future studies willhave to address this challenge, perhaps by using smallflexible endoscopes, by supplementing topical spray nasalanesthesia with local injection, by photodocumenting sinu-sotomies, and by using standardized measuring instruments.Although these data were unsuitable for statistical analysis,the study offers observations on sinusotomy size. Immedi-ately after dilation, sinusotomies were approximately thesize of the balloon diameter. In the initial weeks, periostialmucosa edema occurred and the sinusotomy therefore ap-peared small (Fig 5). Thereafter the edema dissipated andthe sinusotomy appeared progressively larger over time(Figs 6-8). At the end of the study period, sinusotomiesappeared to have stabilized at approximately 75% of theinitial dilation.

In this study, the balloon catheter was utilized as a tool toperform maxillary, sphenoid, and frontal sinusotomy, and torelieve obstruction of sinus ostia. Patients with significant

Figure 5 Endoscopic view approximately 2 weeks after balloondilation. The ostium is patent and postdilation edema is present.Endoscopy was possible with only a 2.7-mm scope because of thepreserved ethmoid tissue and edema that limited access.

ethmoid sinus disease received ethmoid treatment with stan-


dard endoscopic cutting instruments. Therefore, patientswith disease in the ethmoid as well as the maxillary, frontal,or sphenoid sinuses had a “hybrid” approach with respect toinstrumentation because both balloon catheter devices andstandard endoscopic instrumentation were used, albeit indifferent sinuses. Our study design anticipated that the in-vestigators would use the balloon devices to perform sinu-sotomy in perhaps 1 or 2 sinuses in the course of a typical

Figure 6 Endoscopic view of ostium approximately 12 weeksafter balloon catheter sinusotomy. The ostium is patent and edemahas resolved.

Figure 7 Endoscopic view of ostium approximately 9 months
after treatment showing durable patency.
sinus surgery in which treatment was anticipated for 4 to 6sinuses. We anticipated balloon catheter treatment of anisolated sinus in 5 percent to 10 percent of cases, providingthe opportunity to observe catheter-based therapy withoutthe confounding variable of concurrent use of traditionalendoscopic cutting instruments. Surprisingly, as the studyprogressed, participating surgeons were pleased with theballoon catheter treatment and used the devices more fre-quently. This natural and independent evolution yielded alarger cohort of patients who received treatment with onlythe balloon devices in 52 of 109 patients (47.7%). Althoughthis is an interesting finding, no claim is made to compareballoon catheter sinusotomy as a stand-alone technologywith traditional endoscopic sinus surgery.

The specific roles for sinusotomy using balloon catheterdevices in sinusitis are not yet fully determined, and delin-eating these roles was not the study objective. As with othernew medical devices, specific roles will emerge from addi-tional clinical experience and research. Our initial impres-sion of balloon catheter treatment of the sinuses, in itscurrent form, is that it is not appropriate for all sinusitispatients. Patients with sinonasal polyps or extensive previ-ous surgery with significant osteoneogenesis are not appro-priate candidates. Also, current balloon devices do not ad-dress ethmoid disease. Candidate cases include chronicsinusitis limited mostly to ostial obstruction of the frontal,sphenoid, or maxillary sinuses. Cases of isolated sphenoidand frontal sinusitis are particularly attractive for ballooncatheter devices to avoid resection of normal ethmoid si-nuses simply to approach/expose, as is often practiced in

Figure 8 Coronal sinus CT scan of patient in Figure 1A 24weeks after balloon catheter treatment, which shows a patentsinusotomy and resolution of maxillary sinus disease.

functional endoscopic sinus surgery (Fig 9A and B).


In a device performance study with a major objective ofascertaining device safety, a highly restrictive study designcould yield results that are not applicable to general use. Inour study, the clinical decisions of when to use the devicesand how to use them in the context of a given patient’sdisease were largely left up to the individual practitioner.We did not specify the sequence of intervention to theinvestigating rhinologist when balloon catheter dilation wasperformed in the setting of an endoscopic ethmoidectomy.

Figure 9 (A) Patient with an isolated right frontal sinusitis witha massive type IV frontal cell obstructing the outflow tract, thusproducing a frontal mucocele. (B) Patient 24 weeks after frontalsinusotomy using balloon catheter devices with irrigation of thesinus. The sinus opacification has cleared. The medial wall of thefrontal cell has been displaced laterally by the balloon dilation toimprove the frontal outflow tract.

We did not know before the study if one sequence was

preferable to another and felt that this would emerge natu-rally during the investigation. Interestingly, investigatorspreferred to use the balloon catheters first when an inter-vention was indicated in the frontal recess along side aplanned endoscopic ethmoidectomy. When they performedthe subsequent endoscopic ethmoidectomy, they did notdissect the ethmoid components that comprise the frontalrecess such as the superior aspect of the uncinate processand the superior posterior and medial aspect of the aggernasi cell. In this way, the treatment conferred to the frontalrecess/frontal sinus outflow tract was a result of the ballooncatheter dilation, not endoscopic dissection.

In this study, the investigators provided the same post-operative care to study patients that they provide in theirpractices to their endoscopic sinus surgery patients. Theydid not alter their typical individual pre- or postoperativecare for the study. By allowing rhinologists to practice asthey typically practice, we were able to gain an appreciationof device performance in a “real-world setting.” This is animportant aspect to study design when evaluating the safetyof a new device. As in any study design, there are compro-mises, and we acknowledge that not controlling for postop-erative medical therapy across study sites introduces a variablethat could influence our results. However, we conducted amultiple site study, which should tend to minimize any influ-ence from an individual practice pattern on the overall studyresults. Balloon sinuplasty is new and many studies with var-ious designs will be helpful at this early stage.

This investigation builds on the initial pilot study inhumans in which balloon catheters were used safely andperformed well in the hands of one surgeon in a highlycontrolled setting. Herein, 9 surgeons in various practicesettings used the devices in a target population. The abilityof the devices to dilate sinus ostia safely was demonstratedin an expanded number of patients, and insight into patientoutcomes was obtained. Clinical investigations for medicaldevices most commonly are case series (single arm/no con-trol group) that evaluate safety, device performance, andeffectiveness at performing the intended task. In this study,it is interesting and exciting that patients reported improvedSNOT 20 scores after balloon dilation. Future studies canincorporate controls to help ensure that the positive effectsare attributable to the balloon catheter intervention and notconfounding variables such as natural history, concomitantmedical therapy, subjects trying to please their physicianinvestigator, or subjects answering the SNOT 20 favorablybecause of enthusiasm from participating in an innovativenew treatment.

When introducing new technology, potential adverse ef-fects, cost, and user training are important considerations.Our study demonstrates that the radiation exposure fromfluoroscopic guidance of the balloon catheter (a therapeuticintervention) is relatively low and is similar to radiationexposure from common diagnostic tests such as a chest CTscan. However, patients treated with currently accepted
medical treatment or endoscopic sinus surgery are not ex-


posed to fluoroscopy/radiation. Therefore, added radiationexposure, even minimal, should be justified. Current usersof balloon technology anecdotally indicate that reducedtissue trauma, reduced pain, reduced hospital stay, and fa-cilitation in navigating complex sinus anatomy justify theaddition of fluoroscopy. Future studies should quantify thebenefit derived from fluoroscopy to weigh it against expo-sure risks. Regarding costs, innovation of new medicaldevices is an expensive process leading to the need torecover development costs. However, increased health careexpenses due to the balloon catheter devices should opti-mally be balanced by tangible benefits such as a reduction ininvasiveness of the intervention, hospital stay, recoverytime, postoperative debridements, postoperative medica-tions, and office follow-up visits. A recent investigationfound the overall costs of traditional endoscopic sinus sur-gery and balloon catheter dilation to be similar.21 Recentstudies also suggest that postoperative pain, narcotic use,and epistaxis are less, while patient satisfaction is greaterwith balloon catheter treatment.19,21 Results from these ini-tial studies are encouraging, and additional studies will behelpful. Finally, physician training is essential to the safeand effective use of a new device. Otolaryngologists have askill set that is well-suited to catheter devices; investigatorsin this study were able to use the devices safely and effec-tively in their patients after a 1-day cadaver laboratoryexperience. Manipulating catheters and working from afluoroscopy monitor is a different experience for most oto-laryngologists, and cadaver training is very helpful in pre-paring one for actual patient care with the new devices.

Chronic sinusitis is a difficult disease to study and pre-sents inherent study challenges. Case definition, case selec-tion, and establishment of adequate control groups are prob-lematic. While this study design is open to comment andcritique, balloon catheter technology should not be held to adifferent standard than that used for microdebrider technol-ogy or other endoscopic sinus surgery instrumentation. Re-cent reports indicate that approximately 93% of studiesinvolving sinusitis are level 4 evidence (case series withoutan internal control group).20 Investigations that offer evi-dence, level 1 (randomized controlled trial) or 2 (prospec-tive cohort study with an internal control group), are rare.To the best of the authors’ knowledge, there are no multi-center clinical trials that study safety, efficacy, and patientoutcomes for current endoscopic instrumentation. The in-vestigators feel it benefits patients and our specialty if stud-ies are performed to evaluate new devices and technologies.

The results of this study may stimulate discussion aboutthe pathophysiologic mechanisms involved in sinusitis. Per-forming sinusotomy with balloon catheters treats patients inconcert with the original principles upon which endoscopicsinus surgery was developed and popularized: relief of os-tial obstruction and restoration of the sinus cycle ofhealth.22,23 Treating patients along these original principles
can be accomplished with several types of instrumentation,
such as ostial seekers/dilators, cutting forceps, microdebrid-ers, and now balloon catheters.

The initial success of this first-generation device inachieving its stated objective of performing sinusotomy viaa highly minimally invasive approach opens the possibilityfor future catheter device innovation. Future research anddevice design could address chronic infection or chroniceosinophilic inflammation and provide additional treatmentoptions for patients in the future. In other specialties, such ascardiology in which catheter-based treatment was adopted,first-generation catheter devices (balloon catheters) providedincremental treatment improvement, second-generation de-vices (cardiac stents) provided additional incremental improve-ment, yet third-generation devices (drug-eluting stents) pro-vided transformational results for patients. Additional researchwith sinus catheter devices must continue to explore the pos-sibility of similar improvements for our patients.

CONCLUSION

This study confirms results from earlier safety and feasibil-ity studies in anatomic specimens in a small, highly con-trolled cohort of patients. The results from this multicenterstudy indicate that balloon catheter technology has a satis-factory safety profile and is an effective minimally invasivetreatment option to relieve sinus ostial obstruction. Patientswere pleased and indicated they experienced symptomaticimprovement after sinusotomy with balloon catheter de-vices.

ACKNOWLEDGEMENTS

The authors wish to acknowledge the kind assistance in statistical analysisand data management of Ms Lois Kellerman, MS, statistical consultant.The authors would like to thank Tim Smith, MD, MPH, for his assistanceand advice in answering our many questions on management and presen-tation of outcomes data. Finally, the authors would like to thank Alina Kim,Debbie Cogan, and Su-Mien Chong of Acclarent for the kind assistanceand support they provided to the clinical sites.

AUTHOR INFORMATION

From the Maryland Sinus Center (Dr Bolger), Bethesda; the SandringhamDistrict Memorial Hospital (Dr Brown), Bayside Network, Melbourne;Loma Linda University (Dr Church); the University of California-SanFrancisco (Dr Goldberg); the Ohio Sinus Institute (Dr Karanfilov), Colum-bus; the Georgia Nasal and Sinus Institute (Dr Kuhn), Savannah; theCleveland Nasal, Sinus and Sleep Center (Dr Levine); the Alabama Nasaland Sinus Center (Dr Sillers), Birmingham; the California Sinus Institute(Dr Vaughan), Palo Alto; and the Sinus Center of the South (Dr Weiss),Biloxi.

Corresponding author: William E. Bolger, MD, Maryland Sinus Center,Suburban ENT Associates, 6420 Rockledge Drive, Suite 4200, Bethesda,MD 20817.

E-mail address: [email protected].


FINANCIAL DISCLOSURE

William E. Bolger, MD Acclarent Inc. – Scientific Advisory Board,Consultant, minor shares Gyrus ENT – Scientific Advisory Board, Royal-ties, Serim Research – Consultant; Christopher Church, MD AcclarentInc. – Consultant; Andrew Goldberg, MD: Aspire Medical Consultant;Boris Karanfilov, MD: Acclarent Inc. – Consultant, Serim Research –Consultant; Frederick A. Kuhn, MD. Acclarent Inc. – Scientific AdvisoryBoard, General Electric Medical Systems Navigation – S.A.B., Gyrus ENT– Scientific Advisory Board, Serim Research – Consultant, Naryx – ScientificAdvisory Board; Howard Levine, MD: Sinucare – Medical Director,Medtronic Xomed – Consultant, Acclarent Inc.– Scientific Advisory Board,Consultant; Michael J. Sillers, MD: Acclarent Inc.–Scientific Advisory; Win-ston Vaughan, MD: Naryx – Scientific Advisory Board, Consultant, Acclar-ent Inc. – Scientific Advisory Board, Consultant, Telum – Scientific AdvisoryBoard, Consultant, GE Medical – Scientific Advisory Board, Consultant: RayWeiss, MD: GE – Advisory Board, Consultant, Acclarent Inc. – AdvisoryBoard, Consultant.

The sponsor (Acclarent Inc) provided funding for the investigation as wellas administrative and logistical support in coordinating the investigationacross the various study sites.

REFERENCES

1. Ahrendt SA, Pitt HA, Kalloo AN, et al. Primary sclerosing cholangitis:resect, dilate or transplant? Ann Surg 1998;227:412–23.

2. Mestres CA, Ninot S, Cardona M, et al. Early results with intraoper-ative transluminal coronary artery balloon dilatation. Tex Heart Inst J1985;12:345–8.

3. Ebeid MR, Sarris GE, Drummond-Webb JJ, et al. Immediate postop-erative balloon dilatation of neonatal long segment stenosis of thedescending thoracic aorta. J Invasive Cardiol 2001;13:44–6.

4. Omran R, Criado FJ, Wilson EP. Intervention for peripheral vasculardisease endovascular AAA repair: management strategies for the iliacartery. J Invasive Cardiol 2000;12:221–4.

5. Bolger WE, Vaughan WC. Catheter based dilation of the sinus ostia:initial safety and feasibility analysis in a cadaver model. Am J Rhi-nology 2006;20:290–4.

6. Brown C, Bolger WE. Safety and feasibility of balloon catheter dila-tion of paranasal sinus ostia: a preliminary investigation. Ann Otol
Rhinol Laryngol 2006;115:293–9.
7. Piccirillo JF, Merrit MG, Michele RL. Psychometric and clinimetricvalidity of the 20-item sino-nasal outcome test (SNOT-20). Otolaryn-gol Head Neck Surg 2002;126:41–7.

8. Lund VJ, Draf W, Friedman WH, et al. Quantification for stagingsinusitis. Ann Otol Rhinol Laryngol Suppl 1995;167:17–21.

9. Hunt, TK. Wound healing. In Dunphy JE, Way LW, editors. Currentsurgical diagnosis and treatment, 5th ed. Los Altos (CA): LangeMedical Publications; 1981. p. 98.

10. Levenson SM, Geever EG, Craley LV, et al. The healing of rat skinwounds. Ann Surg 1965;161:293.

11. Stankiewicz JA. Complications in endoscopic intranasal ethmoidec-tomy, an update. Laryngoscope 1989;99:686–90.

12. Stankiewicz JA. Complications of endoscopic sinus surgery. Oto ClinN Amer 1989;22:749–58.

13. Lin PH, Bush RL, Peden EK, et al. Carotid artery stenting withneuroprotection: assessing the learning curve and treatment outcome.Am J Surg 2005;190:850–7.

14. Shikora SA, Kim JJ, Tarnoff ME, et al. Laparoscopic Roux-en-Ygastric bypass: results and learning curve of a high-volume academicprogram. Arch Surg 2005;140:362–7.

15. Nowitzke AM. Assessment of the learning curve for lumbar microen-doscopic discectomy. Neurosurgery 2005;56:755–62.

16. Wall BF, Hart D. Revised radiation doses for typical x-ray examina-tions. Br J Radiol 1997;70:437–9.

17. United Nations Scientific Committee on the Effects of Atomic Radi-ation. Sources and effects of ionizing radiation. Vol 1: sources. NewYork: United Nations Publishing; 2000.

18. Jones ML, Piccirillo JF, Haiduk A, et al. Functional endoscopic sinussurgery: do ratings of appropriateness predict patient outcomes. Am JRhinology 1998;12:249–55.

19. Friedman M, Schalch P, Mazloom N, et al. Functional endoscopicdilation of the sinuses: quality of life, patient satisfaction, post oper-ative pain and cost. Presented at the Annual Meeting of the AmericanRhinologic Society, September 16, 2006, Toronto, Ontario, Canada.

20. Wynn R, Vaughan WC. Postoperative recovery: FESS with balloonsinuplasty device. Otolaryngol Head Neck 2006;135:(2 Suppl):P151.

21. Smith TL, Batra PS, Seiden AM, et al. Evidence supporting endo-scopic sinus surgery in the management of adult chronic rhinosinusitis:a systematic review. Am J Rhinology 2005;19:537–43.

22. Naumann H. Patholische anatomic der chronischen rhinitis und sinus-itis. In Proceedings VIII International Congress of Oto-rhino-laryngol-ogy. Amsterdam: Exceprta Medica; 1965. p. 12.

23. Gwaltney JM Jr, Jones JG, Kennedy DW. Medical management ofsinusitis: educational goals and management guidelines. Ann Otol
Rhinol Laryngol Suppl 1995;167:22–30.

Safety and outcomes of balloon catheter sinusotomy: A ... · ORIGINAL RESEARCH Safety and outcomes...

Documents

Transcript of Safety and outcomes of balloon catheter sinusotomy: A ... · ORIGINAL RESEARCH Safety and outcomes...