Risk of atrioesophageal fistula formation with contact force–sensing catheters


      Atrioesophageal fistula formation is a rare but life-threatening complication of atrial fibrillation ablation. Contact force (CF)–sensing catheters improve procedural effectiveness. However, the impact of the implementation of CF-sensing technology on the risk of atrioesophageal fistula formation has not been explored.


      The purpose of this study was to determine the association between the use of CF-sensing catheters and atrioesophageal fistula development.


      We searched the Manufacturer and User Facility Device Experience database for adverse event reports involving Food and Drug Administration–approved ablation catheters.


      Among 2689 device reports, we identified 78 atrioesophageal fistula cases, 65 of which involved CF-sensing catheters and 13 non–CF-sensing catheters. The percentage of total reports involving atrioeosphageal fistula was 5.4% for CF-sensing catheters (65 of 1202) and 0.9% for non–CF-sensing catheters (13 of 1487) (P < .0001). Procedural details (CF and power settings) were not consistently reported. Esophageal temperature increases were detected in only 2.5% of cases (2 of 78). The mean time to presentation was 16 ± 9 days. Overall mortality was at least 56%, with patients who underwent surgical repair more likely to survive than those treated with stenting or no intervention.


      Atrioesophageal fistula formation accounted for a much higher proportion of reported adverse events with CF-sensing catheters compared with non–CF-sensing catheters. Improved understanding of the relationship between power/force delivery and esophageal damage is needed to minimize the risk of atrioesophageal fistula formation.


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        • Cappato R.
        • Calkins H.
        • Chen S.A.
        • Davies W.
        • Iesaka Y.
        • Kalman J.
        • Kim Y.H.
        • Klein G.
        • Natale A.
        • Packer D.
        • Skanes A.
        Prevalence and causes of fatal outcome in catheter ablation of atrial fibrillation.
        J Am Coll Cardiol. 2009; 53: 1798-1803
        • Ghia K.K.
        • Chugh A.
        • Good E.
        • Pelosi F.
        • Jongnarangsin K.
        • Bogun F.
        • Morady F.
        • Oral H.
        A nationwide survey on the prevalence of atrioesophageal fistula after left atrial radiofrequency catheter ablation.
        J Interv Card Electrophysiol. 2009; 24: 33-36
        • Barbhaiya C.R.
        • Kumar S.
        • John R.M.
        • Tedrow U.B.
        • Koplan B.A.
        • Epstein L.M.
        • Stevenson W.G.
        • Michaud G.F.
        Global survey of esophageal and gastric injury in atrial fibrillation ablation: incidence, time to presentation, and outcomes.
        J Am Coll Cardiol. 2015; 65: 1377-1378
        • Ouyang F.
        • Tilz R.
        • Chun J.
        • Schmidt B.
        • Wissner E.
        • Zerm T.
        • Neven K.
        • Kokturk B.
        • Konstantinidou M.
        • Metzner A.
        • Fuernkranz A.
        • Kuck K.H.
        Long-term results of catheter ablation in paroxysmal atrial fibrillation: lessons from a 5-year follow-up.
        Circulation. 2010; 122: 2368-2377
        • Natale A.
        • Reddy V.Y.
        • Monir G.
        • et al.
        Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial.
        J Am Coll Cardiol. 2014; 64: 647-656
        • Reddy V.Y.
        • Dukkipati S.R.
        • Neuzil P.
        • et al.
        Randomized, controlled trial of the safety and effectiveness of a contact force-sensing irrigated catheter for ablation of paroxysmal atrial fibrillation: results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) Study.
        Circulation. 2015; 132: 907-915
        • Afzal M.R.
        • Chatta J.
        • Samanta A.
        • Waheed S.
        • Mahmoudi M.
        • Vukas R.
        • Gunda S.
        • Reddy M.
        • Dawn B.
        • Lakkireddy D.
        Use of contact force sensing technology during radiofrequency ablation reduces recurrence of atrial fibrillation: a systematic review and meta-analysis.
        Heart Rhythm. 2015; 12: 1990-1996
        • Reddy V.Y.
        • Shah D.
        • Kautzner J.
        • et al.
        The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study.
        Heart Rhythm. 2012; 9: 1789-1795
        • Neuzil P.
        • Reddy V.Y.
        • Kautzner J.
        • Petru J.
        • Wichterle D.
        • Shah D.
        • Lambert H.
        • Yulzari A.
        • Wissner E.
        • Kuck K.-H.
        Electrical reconnection after pulmonary vein isolation is contingent on contact force during initial treatment: results from the EFFICAS I study.
        Circ Arrhythm Electrophysiol. 2013; 6: 327-333
        • Shurrab M.
        • Di Biase L.
        • Briceno D.F.
        • Kaoutskaia A.
        • Haj-Yahia S.
        • Newman D.
        • Lashevsky I.
        • Nakagawa H.
        • Crystal E.
        Impact of contact force technology on atrial fibrillation ablation: a meta-analysis.
        J Am Heart Assoc. 2015; 4: e002476
        • Gillinov A.M.
        • Pettersson G.
        • Rice T.W.
        Esophageal injury during radiofrequency ablation for atrial fibrillation.
        J Thorac Cardiovasc Surg. 2001; 122: 1239-1240
        • Ikeda A.
        • Nakagawa H.
        • Lambert H.
        • Shah D.C.
        • Fonck E.
        • Yulzari A.
        • Sharma T.
        • Pitha J.V.
        • Lazzara R.
        • Jackman W.M.
        Relationship between catheter contact force and radiofrequency lesion lize and incidence of steam pop in the beating canine heart: electrogram amplitude, impedance, and electrode temperature are poor predictors of electrode-tissue contact force and lesion Size.
        Circ Arrhythm Electrophysiol. 2014; 7: 1174-1180
        • Thiagalingam A.
        • D’Avila A.
        • Foley L.
        • Guerrero J.L.
        • Lambert H.
        • Leo G.
        • Ruskin J.N.
        • Reddy V.Y.
        Importance of catheter contact force during irrigated radiofrequency ablation: evaluation in a porcine ex vivo model using a force-sensing catheter.
        J Cardiovasc Electrophysiol. 2010; 21: 806-811
      1. Bhaskaran A, Chik W, Pouliopoulos J, Nalliah C, Qian P, Barry T, Nadri F, Samanta R, Tran Y, Thomas S, Kovoor P, Thiagalingam A. Five seconds of 50-60 W radio frequency atrial ablations were transmural and safe: an in vitro mechanistic assessment and force-controlled in vivo validation [published online ahead of print May 20, 2016]. Europace.pii: euw077.

        • Mohanty S.
        • Santangeli P.
        • Mohanty P.
        • et al.
        Outcomes of atrioesophageal fistula following catheter ablation of atrial fibrillation treated with surgical repair versus esophageal stenting.
        J Cardiovasc Electrophysiol. 2014; 25: 579-584
        • Singh S.M.
        • d’Avila A.
        • Singh S.K.
        • Stelzer P.
        • Saad E.B.
        • Skanes A.
        • Aryana A.
        • Chinitz J.S.
        • Kulina R.
        • Miller M.A.
        • Reddy V.Y.
        Clinical outcomes after repair of left atrial esophageal fistulas occurring after atrial fibrillation ablation procedures.
        Heart Rhythm. 2013; 10: 1591-1597
        • Chavez P.
        • Messerli F.H.
        • Casso Dominguez A.
        • Aziz E.F.
        • Sichrovsky T.
        • Garcia D.
        • Barrett C.D.
        • Danik S.
        Atrioesophageal fistula following ablation procedures for atrial fibrillation: systematic review of case reports.
        Open Heart. 2015; 2: e000257
        • Singh S.M.
        • d’Avila A.
        • Doshi S.K.
        • Brugge W.R.
        • Bedford R.A.
        • Mela T.
        • Ruskin J.N.
        • Reddy V.Y.
        Esophageal injury and temperature monitoring during atrial fibrillation ablation.
        Circ Arrhythm Electrophysiol. 2008; 1: 162-168
        • Di Biase L.
        • Saenz L.C.
        • Burkhardt D.J.
        • et al.
        Esophageal capsule endoscopy after radiofrequency catheter ablation for atrial fibrillation: documented higher risk of luminal esophageal damage with general anesthesia as compared with conscious sedation.
        Circ Arrhythm Electrophysiol. 2009; 2: 108-112
        • Cummings J.E.
        • Barrett C.D.
        • Litwak K.N.
        • et al.
        Esophageal luminal temperature measurement underestimates esophageal tissue temperature during radiofrequency ablation within the canine left atrium: comparison between 8 mm tip and open irrigation catheters.
        J Cardiovasc Electrophysiol. 2008; 19: 641-644
        • Gianni C.
        • Atoui M.
        • Mohanty S.
        • et al.
        Difference in thermodynamics between two types of esophageal temperature probes: insights from an experimental study.
        Heart Rhythm. 2016; 13: 2195-2200
        • Muller P.
        • Dietrich J.W.
        • Halbfass P.
        • Abouarab A.
        • Fochler F.
        • Szollosi A.
        • Nentwich K.
        • Roos M.
        • Krug J.
        • Schade A.
        • Mugge A.
        • Deneke T.
        Higher incidence of esophageal lesions after ablation of atrial fibrillation related to the use of esophageal temperature probes.
        Heart Rhythm. 2015; 12: 1464-1469
        • Nguyen D.T.
        • Barham W.
        • Zheng L.
        • Dinegar S.
        • Tzou W.S.
        • Sauer W.H.
        Effect of radiofrequency energy delivery in proximity to metallic medical device components.
        Heart Rhythm. 2015; 12: 2162-2169
        • Food and Drug Administration, HHS
        Unique device identification system; final rule.
        Fed Regist. 2013; 78: 58785-58828
        • Chatterjee S.
        • Herrmann H.C.
        • Wilensky R.L.
        • Hirshfeld J.
        • McCormick D.
        • Frankel D.S.
        • Yeh R.W.
        • Armstrong E.J.
        • Kumbhani D.J.
        • Giri J.
        Safety and procedural success of left atrial appendage exclusion with the Lariat device: a systematic review of published reports and analytic review of the FDA MAUDE database.
        JAMA Intern Med. 2015; 175: 1104-1109
        • John R.M.
        • Kapur S.
        • Ellenbogen K.A.
        • Koneru J.N.
        Atrioesophageal fistula formation with cryoballoon ablation is most commonly related to the left inferior pulmonary vein.
        Heart Rhythm. 2017; 14: 184-189

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