In reference to Balloon catheter technology in rhinology: Reviewing the evidence

We are writing on behalf of the BREATHE I study investigators. For background purposes regarding this Letter to the Editor, the BREATHE I study was a nonrandomized trial that studied 71 patients with documented, medically refractory, chronic rhinosinusitis (CRS) disease specifically involving the maxillary or maxillary and anterior ethmoid sinuses by computed tomography scan evidence. The patient population in this study was well defined, and patients were treated with balloon-only dilation of the maxillary sinus and ethmoid infundibulum, and followed for 24 months. The 24-month data has yet to be published in a peer-reviewed journal; however, the 6-month data on the first 30 patients (56 maxillary ostium and ethmoid infundibulums treated) has been published, and the 12month data on this cohort was published in the February 2010 issue of the ENT Journal. The readers of The Laryngoscope should be aware that the article ‘‘Balloon Catheter Technology in Rhinology: Reviewing the Evidence,’’ authored by Drs. Batra, Ryan, Sindwani, and Marple, omitted the BREATHE I study 12-month data. This published data shows statistically significant improvement in the Sino-Nasal Outcome Test-20 (Snot-20) scores, with P values of <.0001 in all four of the symptom categories through 1-year follow-up. Although the authors state that their review of the literature was based on articles included in a PubMed search on December 16, 2009, this data was available at the same time as the author’s cited literature. The paper also omitted important 6-month data from the published BREATHE I study. Specifically, the paper omitted the P values for the postprocedure improvements in average SNOT 20 scores for the total study population (P < .0001), as well as the statistically significant symptom improvements within the subgroups of patients with maxillary only (P < .0001) and maxillary/anterior ethmoid disease (P < .0002). Three additional papers were omitted from this review. All of these publications provided data supporting the safety and efficacy of balloon dilation. The authors suggest that the observed patient improvement in the BREATHE I study due to balloon dilation cannot be separated from the potential treatment benefit of the transantral approach. We would like to clarify and clearly state that two simultaneous interventions were not performed as the authors suggest. In fact, the BREATHE I study procedure was tightly controlled by the study protocol, and concurrent procedures were contraindicated in an attempt to prospectively assess the treatment benefit, or lack thereof, of balloon dilation as a stand-alone intervention. The transantral access route was only used to deliver the balloon dilation catheter to the maxillary ostium and ethmoid infundibulum, and not for lavage or irrigation. We are not aware of any studies that have evaluated the mere creation of an access into the sinus, with or without aspiration, as a treatment modality for CRS. As noted by Kennedy et al., ‘‘The efficacy of antral lavage is debatable in treating chronic sinusitis. Rarely is lavage successful with only one intervention. Antral lavage is currently not recommended as a primary treatment for chronic sinusitis. It does not address the primary source of the problem, ostiomeatal complex obstruction, and does not treat the ethmoid sinus disease, which is present most of the time.’’ Based on this information, we do not believe that transantral access played any therapeutic role in the observed symptom improvement. In conclusion, although the authors attempted to objectively interpret the currently available data regarding balloon dilatation techniques for CRS, we feel that they did not fully consider all of the data available to them at the time of their assessment. Even when examining data and publications that were available to them, much of this data was not fully considered nor appropriately interpreted. Although there remains a level of debate regarding the precise role that balloon dilation will play in the overall treatment of CRS, we feel it is important that your readers consider and interpret all of the data available when deciding if this technique provides any benefit for specific patient populations.