BACKGROUND: Pulsed field ablation (PFA) can be myocardium selective, potentially sparing the esophagus during left atrial ablation. In an in vivo porcine esophageal injury model, we compared the effects of newer biphasic PFA with radiofrequency ablation (RFA). METHODS: In 10 animals, under general anesthesia, the lower esophagus was deflected toward the inferior vena cava using an esophageal deviation balloon, and ablation was performed from within the inferior vena cava at areas of esophageal contact. Four discrete esophageal sites were targeted in each animal: 6 animals received 8 PFA applications/site (2 kV, multispline catheter), and 4 animals received 6 clusters of irrigated RFA applications (30 W×30 seconds, 3.5 mm catheter). All animals were survived to 25 days, sacrificed, and the esophagus submitted for pathological examination, including 10 discrete histological sections/esophagus. RESULTS: The animals weight increased by 13.7±6.2% and 6.8±6.3% (P=0.343) in the PFA and RFA cohorts, respectively. No PFA animals (0 of 6, 0%) developed abnormal in-life observations, but 1 of 4 RFA animals (25%) developed fever and dyspnea. On necropsy, no PFA animals (0 of 6, 0%) demonstrated esophageal lesions. In contrast, esophageal injury occurred in all RFA animals (4 of 4, 100%; P=0.005): a mean of 1.5 mucosal lesions/animal (length, -21.8±8.9 mm; width, -4.9±1.4 mm) were observed, including one esophago-pulmonary fistula and deep esophageal ulcers in the other animals. Histological examination demonstrated tissue necrosis surrounded by acute and chronic inflammation and fibrosis. The necrotic RFA lesions involved multiple esophageal tissue layers with evidence of arteriolar medial thickening and fibrosis of periesophageal nerves. Abscess formation and full-thickness esophageal wall disruptions were seen in areas of perforation/fistula. CONCLUSIONS: In this novel porcine model of esophageal injury, biphasic PFA induced no chronic histopathologic esophageal changes, while RFA demonstrated a spectrum of esophageal lesions including fistula and deep esophageal ulcers and abscesses.

Farapulse Inc Menlo Park CA

Helmsley Electrophysiology Center Icahn School of Medicine at Mount Sinai New York NY

Homolka Hospital Prague Czech Republic

LLC Pathology Consultant West Hartford CT

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Nair KK, Danon A, Valaparambil A, Koruth JS, Singh SM. Atrioesophageal fistula: a review. J Atr Fibrillation. 2015;8:1331. doi: 10.4022/jafib.1331. PubMed PMC

Koruth JS, Chu EW, Bhardwaj R, Dukkipati S, Reddy VY. Esophageal damage during epicardial ventricular tachycardia ablation. JACC Clin Electrophysiol. 2017;3:1470–1471. doi: 10.1016/j.jacep.2017.03.016. PubMed

Kapur S, Barbhaiya C, Deneke T, Michaud GF. Esophageal injury and atrioesophageal fistula caused by ablation for atrial fibrillation. Circulation. 2017;136:1247–1255. doi: 10.1161/CIRCULATIONAHA.117.025827. PubMed

Lim HW, Cogert GA, Cameron CS, Cheng VY, Sandler DA. Atrioesophageal fistula during cryoballoon ablation for atrial fibrillation. J Cardiovasc Electrophysiol. 2014;25:208–213. doi: 10.1111/jce.12313. PubMed

Black-Maier E, Pokorney SD, Barnett AS, Zeitler EP, Sun AY, Jackson KP, Bahnson TD, Daubert JP, Piccini JP. Risk of atrioesophageal fistula formation with contact force-sensing catheters. Heart Rhythm. 2017;14:1328–1333. doi: 10.1016/j.hrthm.2017.04.024. PubMed

Neven K, Schmidt B, Metzner A, Otomo K, Nuyens D, De Potter T, Chun KR, Ouyang F, Kuck KH. Fatal end of a safety algorithm for pulmonary vein isolation with use of high-intensity focused ultrasound. Circ Arrhythm Electrophysiol. 2010;3:260–265. doi: 10.1161/CIRCEP.109.922930. PubMed

Kaminska I, Kotulska M, Stecka A, Saczko J, Drag-Zalesinska M, Wysocka T, Choromanska A, Skolucka N, Nowicki R, Marczak J, et al. Electroporation-induced changes in normal immature rat myoblasts (H9C2). Gen Physiol Biophys. 2012;31:19–25. doi: 10.4149/gpb_2012_003. PubMed

Li W, Fan Q, Ji Z, Qiu X, Li Z. The effects of irreversible electroporation on nerves. PLoS One. 2011;6:e18331. doi: 10.1371/journal.pone.0018831. PubMed PMC

Edd JF, Horowitz L, Davalos RV, Mir LM, Rubinsky B. In vivo results of a new focal tissue ablation technique: irreversible electroporation. IEEE Trans Biomed Eng. 2006;53:1409–1415. doi: 10.1109/TBME.2006.873745. PubMed

Davalos RV, Mir IL, Rubinsky B. Tissue ablation with irreversible electroporation. Ann Biomed Eng. 2005;33:223–231. doi: 10.1007/s10439-005-8981-8. PubMed

van Driel VJ, Neven KG, van Wessel H, du Pré BC, Vink A, Doevendans PA, Wittkampf FH. Pulmonary vein stenosis after catheter ablation: electroporation versus radiofrequency. Circ Arrhythm Electrophysiol. 2014;7:734–738. doi: 10.1161/CIRCEP.113.001111. PubMed

van Driel VJ, Neven K, van Wessel H, Vink A, Doevendans PA, Wittkampf FH. Low vulnerability of the right phrenic nerve to electroporation ablation. Heart Rhythm. 2015;12:1838–1844. doi: 10.1016/j.hrthm.2015.05.012. PubMed

Neven K, van Es R, van Driel V, van Wessel H, Fidder H, Vink A, Doevendans P, Wittkampf F. Acute and long-term effects of full-power electroporation ablation directly on the porcine esophagus. Circ Arrhythm Electrophysiol. 2017;10:e004672. doi: 10.1161/CIRCEP.116.004672. PubMed

du Pré BC, van Driel VJ, van Wessel H, Loh P, Doevendans PA, Goldschmeding R, Wittkampf FH, Vink A. Minimal coronary artery damage by myocardial electroporation ablation. Europace. 2013;15:144–149. doi: 10.1093/europace/eus171. PubMed

Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed field ablation for pulmonary vein isolation in atrial fibrillation. J Am Coll Cardiol. 2019;74:315–326. doi: 10.1016/j.jacc.2019.04.021. PubMed

Reddy VY, Koruth J, Jais P, Petru J, Timko F, Skalsky I, Hebeler R, Labrousse L, Barandon L, Kralovec S, et al. Ablation of atrial fibrillation with pulsed electric fields: an ultra-rapid, tissue-selective modality for cardiac ablation. JACC Clin Electrophysiol. 2018;4:987–995. doi: 10.1016/j.jacep.2018.04.005. PubMed

Koruth J, Kuroki K, Iwasawa J, Enomoto Y, Viswanathan R, Brose R, Buck ED, Speltz M, Dukkipati SR, Reddy VY. Preclinical evaluation of pulsed field ablation: electrophysiological and histological assessment of thoracic vein isolation. Circ Arrhythm Electrophysiol. 2019;12:e007781. doi: 10.1161/CIRCEP.119.007781. PubMed PMC

Hong J, Stewart MT, Cheek DS, Francischelli DE, Kirchhof N. Cardiac ablation via electroporation. Conf Proc IEEE Eng Med Biol Soc. 2009;2009:3381–3384. doi: 10.1109/IEMBS.2009.5332816. PubMed

Ripley KL, Gage AA, Olsen DB, Van Vleet JF, Lau CP, Tse HF. Time course of esophageal lesions after catheter ablation with cryothermal and radiofrequency ablation: implication for atrio-esophageal fistula formation after catheter ablation for atrial fibrillation. J Cardiovasc Electrophysiol. 2007;18:642–646. doi: 10.1111/j.1540-8167.2007.00790.x. PubMed

Stewart MT, Haines DE, Verma A, Kirchhof N, Barka N, Grassl E, Howard B. Intracardiac pulsed field ablation: proof of feasibility in a chronic porcine model. Heart Rhythm. 2019;16:754–764. doi: 10.1016/j.hrthm.2018.10.030. PubMed

Gabriel C, Peyman A, Grant EH. Electrical conductivity of tissue at frequencies below 1 MHz. Phys Med Biol. 2009;54:4863–4878. doi: 10.1088/0031-9155/54/16/002. PubMed

Yokoyama K, Nakagawa H, Seres KA, Jung E, Merino J, Zou Y, Ikeda A, Pitha JV, Lazzara R, Jackman WM. Canine model of esophageal injury and atrial-esophageal fistula after applications of forward-firing high-intensity focused ultrasound and side-firing unfocused ultrasound in the left atrium and inside the pulmonary vein. Circ Arrhythm Electrophysiol. 2009;2:41–49. doi: 10.1161/CIRCEP.108.807925. PubMed

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