Received: 14 November 2017 Revised: 2 March 2018 Accepted: 26 March 2018 DOI: 10.1111/pace.13345 DEVICES Isolation of pulmonary veins using a thermoreactive implantable device with external energy transfer: Evaluation in a porcine model Tim Boussy MD 1 Tim Vandecasteele DVM 2 Lisse Vera DVM 3 Stijn Schauvliege DVM, PhD 4 Matthew Philpott IR 5 Eli Clement IR 5 Gunther van Loon DVM, Phd 3 Udi Willenz DVM 6 Juan F. Granada MD 7 Gregg W. Stone MD 8 Vivek Y. Reddy MD 9 Glenn Van Langenhove MD, PhD 5 1 Department of Cardiology, AZ Groeninge Kortrijk/AZM Middelares, Ghent, Belgium 2 Department of Morphology, Faculty of Vet- erinary Medicine, Ghent University, Ghent, Belgium 3 Department of Large Animal Internal Medicine, Faculty of Veterinary Medicine, Ghent Univer- sity, Ghent, Belgium 4 Department of Surgery and Anesthesia of Domestic Animals, Ghent University, Ghent, Belgium 5 Fulgur Medical, Merelbeke, Belgium 6 Lahav CRO, Laboratory of Preclinical Services, Kibbutz Lahav, Israel 7 CRF-Skirball Center for Innovation, Orange- burg, NY, USA 8 Cardiovascular Research Foundation, Columbia University, New York, NY, USA 9 Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, USA Correspondence Tim Vandecasteele, Department of Morphology, Faculty of Veterinary Medicine, University Ghent, Salisburylaan 133, 9820 Merelbeke, Belgium. Email:Tim.Vandecasteele@Ugent.be Sources of Funding: None. Disclosures: G. Van Langenhove is founder of the company Fulgur medical and has equity. E. Clement and M. Phillpott both are employees of Fulgur Medical, the company that developed the implant, the applicator, and the delivery system. Abstract Background: Pulmonary vein isolation (PVI) is a well-established method for the treatment of symptomatic paroxysmal atrial fibrillation, but is only partly successful with a high rate of elec- trical reconnection. We introduce a novel technique in which PVI is accomplished by noninvasive heating of a dedicated thermoresponse implant inserted into the pulmonary veins (PV), demon- strated in a porcine model. Methods: A self-expanding nitinol-based implant was positioned in the common inferior PV of 11 pigs, using a fluoroscopy-guided transatrial appendage approach. Ablation was performed through contactless energy transfer from a primary extracorporal coil to a secondary heat ring (HR) embedded in the proximal part of the implant. Electrophysiological conduction was assessed prior to and postablation, and at 3 months. Histological samples were obtained acutely (n = 4) and after 3 months (n = 7). Results: In total, 13 PV implants were successfully positioned in the inferior PVs of 11 animals. Ablation was performed without injury of adjacent structures. PVI and bidirectional block was electrophysiologically confirmed in all cases immediately at the time of implantation and 3 months later in seven chronic animals in whom testing was repeated. Marked evidence of ablation around the proximal HR was evident at 3 months postprocedure, with scar tissue formation and only mild neointimal proliferation. Conclusions: Successful PVI can be obtained by external electromagnetic heat transfer to a novel pulmonary vein implant. KEYWORDS ablation, atrial fibrillation, myocardial sleeve, stent 1 INTRODUCTION Atrial fibrillation (AF) is the most common arrhythmia in human adults. The overall prevalence of AF is estimated between 1.5% and 2% of the general population. 1 Furthermore, since AF can also be asymptomatic, the true prevalence of this disease is likely to be underestimated. Because AF is associated with a fivefold increased risk of stroke and a threefold increased incidence of heart failure, the impact of AF on patient well-being and societal health care expendi- tures is enormous. 2,3 In the last two decades, pulmonary vein isolation (PVI) has become the preferred treatment of patients with paroxysmal atrial fibrillation. Current PVI techniques show 1-year success rates of Pacing Clin Electrophysiol. 2018;1–8. c  2018 Wiley Periodicals, Inc. 1 wileyonlinelibrary.com/journal/pace