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

doi:10.1016/j.jacep.2021.06.002

Radiofrequency Energy Applications Targeting Significant Residual Leaks After Watchman Implantation: A Prospective, Multicenter Experience

JACC Clin Electrophysiol. 2021 Dec;7(12):1573-1584. doi: 10.1016/j.jacep.2021.06.002. Epub 2021 Jul 27.

Authors

Domenico G Della Rocca¹, Ghulam Murtaza², Luigi Di Biase³, Krishna Akella², Subramaniam C Krishnan⁴, Michele Magnocavallo⁵, Sanghamitra Mohanty⁶, Carola Gianni⁶, Chintan Trivedi⁶, Carlo Lavalle⁷, Giovanni B Forleo⁸, Veronica N Natale⁹, Nicola Tarantino¹⁰, Jorge Romero¹⁰, Rakesh Gopinathannair², Philip J Patel¹¹, Mohamed Bassiouny⁶, Armando Del Prete¹², Amin Al-Ahmad⁶, J David Burkhardt⁶, G Joseph Gallinghouse⁶, Javier E Sanchez⁶, Shephal K Doshi¹³, Rodney P Horton⁶, Dhanunjaya Lakkireddy², Andrea Natale¹⁴

Affiliations

¹ Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA. Electronic address: domenicodellarocca@hotmail.it.
² Kansas City Heart Rhythm Institute, Overland Park, Kansas, USA.
³ Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA; Arrhythmia Services, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA; Department of Clinical and Experimental Medicine, University of Foggia, Foggia, Italy.
⁴ Sutter Heart and Vascular Institute, Sacramento, California, USA.
⁵ Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA; Department of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.
⁶ Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA.
⁷ Department of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.
⁸ Department of Cardiology, Azienda Ospedaliera-Universitaria "Luigi Sacco," Milan, Italy.
⁹ Department of Pediatrics, Charlotte R. Bloomberg Children's Center, Johns Hopkins University, Baltimore, Maryland, USA.
¹⁰ Arrhythmia Services, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
¹¹ Eisenhower Desert Cardiology Center, Rancho Mirage, California, USA.
¹² Division of Cardiology, Santa Maria Goretti Hospital, Latina, Italy.
¹³ Cardiology Division, Pacific Heart Institute, Santa Monica, California, USA.
¹⁴ Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA; Interventional Electrophysiology, Scripps Clinic, La Jolla, California, USA; Department of Cardiology, MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.

PMID: 34330671
DOI: 10.1016/j.jacep.2021.06.002

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.

Publication types

Multicenter Study

MeSH terms

Aged
Aged, 80 and over
Atrial Appendage*
Atrial Fibrillation* / surgery
Cardiac Catheterization
Humans
Prospective Studies
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT04726943