@article{f1977611eb5c4d9a9658300bff839d28,
title = "Influence of monitoring and atrial arrhythmia burden on quality of life and health care utilization in patients undergoing pulsed field ablation: A secondary analysis of the PULSED AF Trial",
abstract = "Background: Freedom from atrial arrhythmia (AA) recurrence ≥30 seconds after pulsed field ablation (PFA) in patients with atrial fibrillation (AF) was reported in PULSED AF (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF; ClinialTrials.gov Identifier: NCT04198701). AA burden may be a more clinically meaningful endpoint. Objective: The purpose of this study was to determine the influence of monitoring strategies on AA detection and AA burden association with quality of life (QoL) and health care utilization (HCU) after PFA. Methods: Patients underwent 24-hour Holter monitoring at 6 and 12 months and weekly, and symptomatic transtelephonic monitoring (TTM). AA burden post-blanking was calculated as the greater of (1) percentage of AA on total Holter time; or (2) percentage of weeks with ≥1 TTM with AA out of all weeks with ≥1 TTM. results: Freedom from all AAs varied by >20% when differing monitoring strategies were used. PFA resulted in zero burden in 69.4% of paroxysmal atrial fibrillation (PAF) and 62.2% of persistent atrial fibrillation (PsAF) patients. Median burden was low (<9%). Most PAF and PsAF patients had ≤1 week of AA detection on TTM (82.6% and 75.4%) and <30 minutes of AA per day of Holter monitoring (96.5% and 89.6%), respectively. Only PAF patients with <10% AA burden averaged a clinically meaningful (>19 point) QoL improvement. PsAF patients experienced clinically meaningful QoL improvements irrespective of burden. Repeat ablations and cardioversions significantly increased with higher AA burden (P <.01). Conclusion: The ≥30-second AA endpoint is dependent on the monitoring protocol used. PFA resulted in low AA burden for most patients, which was associated with clinically relevant improvement in QoL and reduced AA-related HCU.",
keywords = "Atrial fibrillation, Burden, Catheter ablation, Electroporation, Pulsed field ablation",
author = "Atul Verma and Haines, {David E.} and Boersma, {Lucas V.} and Nitesh Sood and Andrea Natale and Marchlinski, {Francis E.} and Hugh Calkins and Prashanthan Sanders and Packer, {Douglas L.} and Karl-Heinz Kuck and Gerhard Hindricks and Hiroshi Tada and Hoyt, {Robert H.} and Irwin, {James M.} and Jason Andrade and Jeffrey Cerkvenik and Jada Selma and {PULSED AF Investigators} and DeLurgio, {David B.}",
note = "Funding Information: The authors thank the PULSED AF (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF) sites and their dedicated staff. Also, the authors thank the following Medtronic employees for support during the manuscript development: Birce Onal, Theodore Merriam, Josh Treadway, and Rachelle Kaplon. This study was fully funded by Medtronic, Inc. Drs Verma, Calkins, Haines, Hindricks, Kuck, Marchlinski, Natale, Packer, DeLurgio, Sanders, and Andrade receive grants and/or consultation funds from Medtronic, Inc. Dr Selma is an employee of Medtronic, Inc. Dr Verma receives grants or consultation funds from Biosense Webster (BW), Bayer, Medlumics, Adagio Medical, and Boston Scientific (BS). Dr DeLurgio receives consultation or honoraria funds from AtriCure and BS. Dr Marchlinski receives grants, consultation, or honoraria funds from BW, Abbott Medical (AM), and Biotronik. Dr Sood receives consultation or honoraria funds from Johnson & Johnson, BS, AtriCure, Bristol Myers, and Pfizer. Dr Boersma's Cardiology Department receives consultation funds from Medtronic, BS, AM, Adagio Medical, and Acutus Medical. Dr Kuck receives consultation funds from Cardiovalve. Dr Natale receives consultation funds from AM, Baylis, BW, Biotronik, and BS. Dr Sanders receives grants or honoraria funds from BS, AM, Becton Dickenson, Pacemate, and CathRx. Dr Tada receives honoraria and/or grants from Daiichi Sankyo Co. Ltd. Biotronik Japan, Inc. Bristol Myers Squibb, Nippon Boehringer Ingelheim Co. Ltd. Medtronic Japan Co. Ltd. Novartis Pharma, K.K. AM Japan, LLC, and ALVAUS Inc. Dr Calkins receives consultation or honoraria funds from BS, AM, AtriCure, and BW. Dr Andrade receives grants from Baylis and consultation funds from BW and AM. All other authors have no conflicts to disclose. All authors attest they meet the current ICMJE criteria for authorship. Funding Information: This study was fully funded by Medtronic , Inc. Publisher Copyright: {\textcopyright} 2023 Heart Rhythm Society",
year = "2023",
month = sep,
doi = "https://doi.org/10.1016/j.hrthm.2023.05.018",
language = "English",
volume = "20",
pages = "1238--1245",
journal = "Heart Rhythm",
issn = "1547-5271",
publisher = "Elsevier",
number = "9",
}