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Safety Signal for the Simple Double Ablation Regimen When Using the Barrx 360 Express Radiofrequency Ablation Balloon Catheter
Gastroenterology 2017;-:1
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CORRESPONDENCE Readers may submit letters to the editor concerning articles that appeared in Gastroenterology within one month of publication. Detailed guidelines regarding the content are included in the Instructions to Authors.
Safety Signal for the Simple Double Ablation Regimen When Using the Barrx 360 Express Radiofrequency Ablation Balloon Catheter
Q2
Dear Editors: As principal investigators of an ongoing randomized study evaluating different ablation regimens for the Barrx 360 express RFA balloon catheter (360 Express; GI solutions Covidien/Medtronic, Sunnyvale, CA), we feel the responsibility to communicate our interim finding of an unexpected high rate of severe esophageal stenosis when using the 360 Express with a simplified 2 10 J/cm2 no clean ablation regimen. Radiofrequency ablation (RFA) has been proven safe and highly effective for eradication of Barrett mucosa with dysplasia, and its use has been adapted in international guidelines.1,2 Recently, the 360 Express balloon catheter has become available, which features the ability to self-adjust to the inner esophageal diameter ensuring optimal tissue contact with the electrode during ablation, without the need of a prior sizing step. In our still ongoing European multicenter randomized trial, we compare 3 ablation regimens for 360 Express treatment: the standard regimen (10 J/cm2 – clean – 10 J/cm2), and 2 simplified regimens (2 10 J/cm2 without in between cleaning, and 1 10 J/cm2). At an interim analysis, however, we found a 17% stenosis rate (4/24) in the 2 10 J/cm2 group, compared with no stenoses in the standard (0/25) and 1 10 J/cm2 (0/22) study groups. In the literature, stenosis after successive RFA treatments has been described in 0%-14% of cases,3 and a large European multicenter trial in 132 patients showed a total stenosis rate of 6%, requiring a median of 1-2 dilatations.4 The 17% stenosis rate found after 1 RFA session at our interim analysis is therefore higher than expected. More important, the severity of the encountered stenoses was more severe than we know from previous studies, with patients requiring >4 dilatation sessions and even incision therapy. Based on these interim findings and
after consultation with the Data Safety Monitoring Board for the study, we decided to stop inclusion in the simplified 2 10 J/cm2 arm, because of an unacceptable risk of severe stenosis in this group. The study will be finished with the remaining required inclusions in the standard arm and the 1 10 J/cm2 arm. With this letter, we would like to send out a safety signal and inform readers on the increased risk of relevant esophageal stenosis when using the 360 Express with a simplified 2 10 J/cm2 no clean regimen. We felt it was important to communicate our findings, because many endoscopists who have been using the 2 10 J/cm2 no clean regimen successfully with the traditional circumferential RFA catheters, might logically copy this approach when using the 360 Express. Until further data from our randomized trial are available, we would therefore advise the use of the standard 2 10 J/cm2 regimen, with cleaning of the catheter and ablation zone in between ablations. ROOS E. POUW JACQUES J. BERGMAN Department of Gastroenterology and Hepatology Academic Medical Center Amsterdam, the Netherlands
Q3
References 1. 2. 3. 4.
Weusten B, et al. Endoscopy 2017;49:191–198. Shaheen NJ, et al. Am J Gastroenterol 2016;111:30–50. Chadwick G, et al. Gastrointest Endosc 2014;79: 718–731. Phoa KN, et al. Gut 2016;65:555–562.
Conflicts of interest The authors have made the following disclosures: J.J. Bergman received Q1 financial support for research from Covidien/Medtronic, Olympus Endoscopy, Cook Medical, Boston Scientific, Erbe Medical, C2Therapeutic, and Ninepoint Medical, and served as a consultant for Boston Scientific, Cook Medical, and Covidien/Medtronic.
http://dx.doi.org/10.1053/j.gastro.2017.05.058
COR 5.4.0 DTD YGAST61234_proof 29 June 2017 9:39 am ce
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CORRESPONDENCE Readers may submit letters to the editor concerning articles that appeared in Gastroenterology within one month of publication. Detailed guidelines regarding the content are included in the Instructions to Authors.
Safety Signal for the Simple Double Ablation Regimen When Using the Barrx 360 Express Radiofrequency Ablation Balloon Catheter
Q2
Dear Editors: As principal investigators of an ongoing randomized study evaluating different ablation regimens for the Barrx 360 express RFA balloon catheter (360 Express; GI solutions Covidien/Medtronic, Sunnyvale, CA), we feel the responsibility to communicate our interim finding of an unexpected high rate of severe esophageal stenosis when using the 360 Express with a simplified 2 10 J/cm2 no clean ablation regimen. Radiofrequency ablation (RFA) has been proven safe and highly effective for eradication of Barrett mucosa with dysplasia, and its use has been adapted in international guidelines.1,2 Recently, the 360 Express balloon catheter has become available, which features the ability to self-adjust to the inner esophageal diameter ensuring optimal tissue contact with the electrode during ablation, without the need of a prior sizing step. In our still ongoing European multicenter randomized trial, we compare 3 ablation regimens for 360 Express treatment: the standard regimen (10 J/cm2 – clean – 10 J/cm2), and 2 simplified regimens (2 10 J/cm2 without in between cleaning, and 1 10 J/cm2). At an interim analysis, however, we found a 17% stenosis rate (4/24) in the 2 10 J/cm2 group, compared with no stenoses in the standard (0/25) and 1 10 J/cm2 (0/22) study groups. In the literature, stenosis after successive RFA treatments has been described in 0%-14% of cases,3 and a large European multicenter trial in 132 patients showed a total stenosis rate of 6%, requiring a median of 1-2 dilatations.4 The 17% stenosis rate found after 1 RFA session at our interim analysis is therefore higher than expected. More important, the severity of the encountered stenoses was more severe than we know from previous studies, with patients requiring >4 dilatation sessions and even incision therapy. Based on these interim findings and
after consultation with the Data Safety Monitoring Board for the study, we decided to stop inclusion in the simplified 2 10 J/cm2 arm, because of an unacceptable risk of severe stenosis in this group. The study will be finished with the remaining required inclusions in the standard arm and the 1 10 J/cm2 arm. With this letter, we would like to send out a safety signal and inform readers on the increased risk of relevant esophageal stenosis when using the 360 Express with a simplified 2 10 J/cm2 no clean regimen. We felt it was important to communicate our findings, because many endoscopists who have been using the 2 10 J/cm2 no clean regimen successfully with the traditional circumferential RFA catheters, might logically copy this approach when using the 360 Express. Until further data from our randomized trial are available, we would therefore advise the use of the standard 2 10 J/cm2 regimen, with cleaning of the catheter and ablation zone in between ablations. ROOS E. POUW JACQUES J. BERGMAN Department of Gastroenterology and Hepatology Academic Medical Center Amsterdam, the Netherlands
Q3
References 1. 2. 3. 4.
Weusten B, et al. Endoscopy 2017;49:191–198. Shaheen NJ, et al. Am J Gastroenterol 2016;111:30–50. Chadwick G, et al. Gastrointest Endosc 2014;79: 718–731. Phoa KN, et al. Gut 2016;65:555–562.
Conflicts of interest The authors have made the following disclosures: J.J. Bergman received Q1 financial support for research from Covidien/Medtronic, Olympus Endoscopy, Cook Medical, Boston Scientific, Erbe Medical, C2Therapeutic, and Ninepoint Medical, and served as a consultant for Boston Scientific, Cook Medical, and Covidien/Medtronic.
http://dx.doi.org/10.1053/j.gastro.2017.05.058
COR 5.4.0 DTD YGAST61234_proof 29 June 2017 9:39 am ce
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