Radiofrequency Energy Applications Targeting Significant Residual Leaks After Watchman Implantation: A Prospective, Multicenter Experience
Domenico G Della Rocca, Ghulam Murtaza, Luigi Di Biase, Krishna Akella, Subramaniam C Krishnan, Michele Magnocavallo, Sanghamitra Mohanty, Carola Gianni, Chintan Trivedi, Carlo Lavalle, Giovanni B Forleo, Veronica N Natale, Nicola Tarantino, Jorge Romero, Rakesh Gopinathannair, Philip J Patel, Mohamed Bassiouny, Armando Del Prete, Amin Al-Ahmad, J David Burkhardt, G Joseph Gallinghouse, Javier E Sanchez, Shephal K Doshi, Rodney P Horton, Dhanunjaya Lakkireddy, Andrea Natale, Domenico G Della Rocca, Ghulam Murtaza, Luigi Di Biase, Krishna Akella, Subramaniam C Krishnan, Michele Magnocavallo, Sanghamitra Mohanty, Carola Gianni, Chintan Trivedi, Carlo Lavalle, Giovanni B Forleo, Veronica N Natale, Nicola Tarantino, Jorge Romero, Rakesh Gopinathannair, Philip J Patel, Mohamed Bassiouny, Armando Del Prete, Amin Al-Ahmad, J David Burkhardt, G Joseph Gallinghouse, Javier E Sanchez, Shephal K Doshi, Rodney P Horton, Dhanunjaya Lakkireddy, Andrea Natale
Abstract
Objectives: The aim of this study was to evaluate the efficacy of radiofrequency (RF) energy applications targeting the atrial side of a significant residual leak in patients with acute and chronic evidence of incomplete percutaneous left atrial appendage (LAA) occlusion.
Background: RF applications have been proved to prevent recanalization of intracranial aneurysms after coil embolization, thereby favoring complete sealing. From a mechanistic standpoint, in vitro and in vivo experiments have demonstrated that RF promotes collagen deposition and tissue retraction.
Methods: Forty-three patients (mean age 75 ± 7 years mean CHA2DS2-VASc score 4.6 ± 1.4, mean HAS-BLED score 4.0 ± 1.1) with residual leaks ≥4 mm after Watchman implantation were enrolled. Procedural success was defined as complete LAA occlusion or presence of a mild or minimal (1- to 2-mm) peridevice leak on follow-up transesophageal echocardiography (TEE), which was performed approximately 45 days after the procedure.
Results: RF-based leak closure was performed acutely after Watchman implantation in 19 patients (44.2%) or scheduled after evidence of significant leaks on follow-up TEE in 24 others (55.8%). The median leak size was 5 mm (range: 4-7 mm). On average, 18 ± 7 RF applications per patient (mean maximum contact force 16 ± 3 g, mean power 44 ± 2 W, mean RF time 5.1 ± 2.5 minutes) were performed targeting the atrial edge of the leak. Post-RF median leak size was 0 mm (range: 0-1 mm). A very low rate (2.3% [n = 1]) of major periprocedural complications was observed. Follow-up TEE revealed complete LAA sealing in 23 patients (53.5%) and negligible residual leaks in 15 (34.9%).
Conclusions: RF applications targeting the atrial edge of a significant peri-Watchman leak may promote LAA sealing via tissue remodeling, without increasing complications. (RF Applications for Residual LAA Leaks [REACT]; NCT04726943).
Keywords: Watchman; atrial fibrillation; leak; left atrial appendage; radiofrequency; stroke; transesophageal echocardiogram.
Conflict of interest statement
Funding Support and Author Disclosures Dr Burkhardt is a consultant for Biosense Webster and Stereotaxis. Dr Di Biase is a consultant for Biosense Webster, Boston Scientific, Stereotaxis, and St. Jude Medical; and has received speaker honoraria from Medtronic, Atricure, EPiEP, and Biotronik. Dr Natale has received speaker honoraria from Abbott, Biosense Webster, Boston Scientific, Biotronik, Baylis, Medtronic; and is a consultant for Biosense Webster, St. Jude Medical, and Janssen. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Copyright © 2021. Published by Elsevier Inc.
Source: PubMed