Multicenter Study on the Safety of Pulsed Field Ablation in Over 40,000 Patients: MANIFEST-US

Mohit K Turagam¹, Arash Aryana², John D Day³, Srinivas R Dukkipati¹, Troy Hounshell⁴, Devi Nair⁵, Andrea Natale⁶, Stanislav Weiner⁷, Jim W Cheung⁸, Larry Chinitz⁹, Frank Cuoco¹⁰, Marcos Daccarett¹¹, Sanjay Dandamudi¹², Alok Gambhir¹³, Maheer Gandhavadi¹⁴, Jamie Kim¹⁵, Mark D Metzl¹⁶, Bradley Mikaelian¹⁷, Darren Peress¹⁸, Jorge E Romero¹⁹, Javier Sanchez²⁰, David A Sandler²¹, Naushad A Shaik²², Michael Shehata²³, Sultan M Siddique²⁴, Abhinav Singh²⁵, Matthew J Singleton²⁶, Sri Sundaram²⁷, Yoel Vivas²⁸, Jonathan W Waks²⁹, Kenneth H Yamamura³⁰, Matthew Zipse³¹, Joon Ahn³², Obadah Al Chekakie³³, Mahmoud Ali³⁴, Nameer Ascandar³⁵, Sandeep Bansal³⁶, Andrew D Beaser³⁷, Jaskanwal Bisla³⁸, Scott Brancato³⁹, David J Callans⁴⁰, Peter Chang-Sing⁴¹, Rashaad Chothia⁴², Joseph Dell'Orfano⁴³, David B DeLurgio⁴⁴, Shephal K Doshi⁴⁵, Lynn Erickson⁴⁶, Sandeep Gautam⁴⁷, Venkateshwar Gottipaty⁴⁸, Sandeep Goyal⁴⁹, Sanjaya Gupta⁵⁰, Jamal Hajjari⁵¹, John D Harding⁵², Jessica Hennessey⁵³, Huy Ho⁵⁴, Ivan Ho⁵⁵, Jonathan C Hsu⁵⁶, Henry D Huang⁵⁷, Matthew Hutchinson⁵⁸, Rachel Kaplan⁵⁹, Sreekanth Karanam⁶⁰, Nayanjyoti Kaushik⁶¹, David N Kenigsberg⁶², Arfaat Khan⁶³, Bradley Knight⁶⁴, Jordan Leyton-Mange⁶⁵, Bernard Lim⁶⁶, Theodore J Maglione⁶⁷, Bobby Malik⁶⁸, Matthew McKillop⁶⁹, Donald Mehlhorn⁷⁰, Davendra Mehta⁷¹, Suneet Mittal⁷², Kent R Nilsson⁷³, Samuel Omotoye⁷⁴, Hakan Oral⁷⁵, Ragesh Panikkath⁷⁶, Apoor Patel⁷⁷, Christian Perzanowski⁷⁸, Anil Rajendra⁷⁹, Mansour Razminia⁸⁰, Samir Saba⁸¹, Jose M Sanchez⁸², Danish Iltaf Satti⁸³, Navinder Sawhney⁸⁴, Dinesh Sharma⁸⁵, Robert Sheppard⁸⁶, Madhurmeet Singh⁸⁷, Jasbir Sra⁸⁸, James E Stone⁸⁹, Ravi Sureddi⁹⁰, Matthew Taylor⁹¹, Todd L Teigeler⁹², Venkat Tholakanahalli⁹³, Amar Trivedi⁹⁴, Kevin M Trulock⁹⁵, Ganesh Venkataraman⁹⁶, Daniel Weitz⁹⁷, Brian D Williamson⁹⁸, Stephen L Winters⁹⁹, Jennifer M Wright¹⁰⁰, Richard Wu¹⁰¹, David Yoo¹⁰², Anthony Aizer⁹, Daniel Dan Alyesh²⁷, Luciano Amado¹¹, Ryan Borne¹⁷, Nagib Chalfoun¹², David Chang¹⁵, Megan Davis¹⁰³, Ashkan Ehdaie²³, Paul Z Gerczuk³⁰, Jefferson H Lee²⁶, Gregory Michaud²⁹, Hiroshi Miyama⁸, Sanghamitra Mohanty⁶, Luis Mora²⁸, George Mounir²², Nischala Nannapaneni³, Jose Nazari¹⁶, Graham Peigh⁶⁴, William H Sauer¹⁹, Darren Sidney¹⁰, Vivek Varughese²⁴, Wendy Tzou³¹, Ugur Gurol¹, Vivek Y Reddy¹⁰⁴; MANIFEST-US Investigators

Affiliations

¹ Icahn School of Medicine at Mount Sinai, New York, New York, USA.
² Mercy General Hospital, Sacramento, California, USA.
³ St Mark's Hospital HCA Healthcare, Salt Lake City, Utah, USA.
⁴ MercyOne Iowa Heart Center, West Des Moines, Iowa, USA.
⁵ St Bernard's Medical Center, Jonesboro, Arkansas, USA.
⁶ Texas Cardiac Arrhythmia Institute, St David's Medical Center, Austin, Texas, USA.
⁷ Christus Trinity Mother Frances Health System, Tyler, Texas, USA.
⁸ Weill Cornell Medicine/New York Presbyterian Hospital, New York, New York, USA.
⁹ NYU Langone Health, New York, New York, USA.
¹⁰ Trident Medical Center, Charleston, South Carolina, USA.
¹¹ St Luke's Medical Center, Boise, Idaho, USA.
¹² Frederik Meijer Heart and Vascular Institute, Corewell Health West, Grand Rapids, Michigan, USA.
¹³ Northside Hospital Cardiovascular Institute, Sandy Springs, Georgia, USA.
¹⁴ Overlake Medical Center, Bellevue, Washington, USA.
¹⁵ Cardiovascular Specialists of New England, Manchester, New Hampshire, USA.
¹⁶ Endeavor Health, Glenview, Illinois, USA.
¹⁷ University of Colorado, Colorado Springs, Colorado, USA.
¹⁸ Pima Heart Physicians, PC, Tucson, Arizona, USA.
¹⁹ Brigham and Women's Hospital, Boston, Massachusetts, USA.
²⁰ Texas Cardiac Arrhythmia Dallas, Dallas, Texas, USA.
²¹ Oklahoma Heart Institute, Tulsa, Oklahoma, USA.
²² AdventHealth Orlando, Orlando, Florida, USA.
²³ Cedars Sinai Smidt Heart Institute, Los Angeles, California, USA.
²⁴ Prisma Health, Columbia, South Carolina, USA.
²⁵ HCA Florida Bayonet Hospital, Hudson, Florida, USA.
²⁶ WellSpan Health, York, Pennsylvania, USA.
²⁷ AdventHealth Porter, Denver, Colorado, USA.
²⁸ The Arrhythmia Center of South Florida, Delray Beach, Florida, USA.
²⁹ Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
³⁰ AdventHealth Tampa, Tampa, Florida, USA.
³¹ University of Colorado Anschutz Campus, Aurora, Colorado, USA.
³² Georgia Heart Institute, Northeast Georgia Health System, Gainesville, Georgia, USA.
³³ AdventHealth Shawnee Mission, Merriam, Kansas, USA.
³⁴ Aurora St Luke's Medical Center, Milwaukee, Wisconsin, USA.
³⁵ HCA Florida Sarasota Doctors Hospital, Sarasota, Florida, USA.
³⁶ Penn Medicine Lancaster General Health, Lancaster, Pennsylvania, USA.
³⁷ University of Chicago Medicine, Chicago, Illinois, USA.
³⁸ Dignity Health Heart Arrhythmia Center, Chandler, Arizona, USA.
³⁹ Providence St Vincent Medical Center, Portland, Oregon, USA.
⁴⁰ Cardiac Electrophysiology Section, Cardiovascular Medicine Division, Department of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁴¹ Providence Santa Rosa Memorial Hospital, Santa Rosa, California, USA.
⁴² Department of Internal Medicine, St Joseph's Medical Center, Stockton, California, USA.
⁴³ Central Maine Medical Center, Lewiston, Maine, USA.
⁴⁴ Emory University School of Medicine, Atlanta, Georgia, USA.
⁴⁵ Pacific Heart Institute, Santa Monica, California, USA.
⁴⁶ Advocate Aurora Research Institute, Advocate Aurora Health, Milwaukee, Wisconsin, USA.
⁴⁷ University of Missouri-Columbia, Columbia, Missouria, USA.
⁴⁸ Medical University of South Carolina, Columbia, South Carolina, USA.
⁴⁹ Piedmont Heart of Buckhead Electrophysiology, Piedmont Heart Institute, Atlanta, Georgia, USA.
⁵⁰ Saint Luke's Mid-America Heart Institute, Kansas City, Missouri, USA.
⁵¹ Penn State Health Holy Spirit Medical Center, Camp Hill, Pennsylvania, USA.
⁵² Doylestown Hospital, Doylestown, Pennsylvania, USA.
⁵³ Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
⁵⁴ HCA Florida Citrus Hospital, Inverness, Florida, USA.
⁵⁵ Keck Medical Center of USC, Los Angeles, California, USA.
⁵⁶ University of California-San Diego, La Jolla, California, USA.
⁵⁷ Rush University Hospital, Chicago, Illinois, USA.
⁵⁸ Division of Cardiovascular Medicine, Department of Medicine, University of Arizona College of Medicine, Tucson, Arizona, USA.
⁵⁹ Medical University of South Carolina, Charleston, South Carolina, USA.
⁶⁰ PeaceHealth Sacred Heart Medical Center RiverBend, Springfield, Oregon, USA.
⁶¹ CHI Health Nebraska Heart Institute, Lincoln, Nebraska, USA.
⁶² Florida Heart and Vascular, Fort Lauderdale, Florida, USA.
⁶³ Henry Ford Health, Detroit, Michigan, USA.
⁶⁴ Northwestern University, Chicago, Illinois, USA.
⁶⁵ Department of Cardiology, Maine Medical Center, Portland, Maine, USA.
⁶⁶ Decatur Memorial Hospital, Decatur, Illinois, USA.
⁶⁷ Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.
⁶⁸ HCA Florida Blake Hospital, Bradenton, Florida, USA.
⁶⁹ Baptist Health System, Jacksonville, Florida, USA.
⁷⁰ HCA Florida Largo Hospital, Largo, Florida, USA.
⁷¹ Mount Sinai Morningside, New York, New York, USA.
⁷² Valley Health System, Paramus, New Jersey, USA.
⁷³ Piedmont Heart Institute, Athens, Georgia, USA.
⁷⁴ Cleveland Clinic, Cleveland, Ohio, USA.
⁷⁵ University of Michigan, Ann Arbor, Michigan, USA.
⁷⁶ French Hospital Medical Center, San Luis Obispo, California, USA.
⁷⁷ Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas, USA.
⁷⁸ Bay Area Cardiology, Tampa, Florida, USA.
⁷⁹ Grandview Medical Center, Birmingham, Alabama, USA.
⁸⁰ Northwestern Medicine, Palos Hospital, Palos Heights, Illinois, USA.
⁸¹ The University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
⁸² St Luke's Hospital, Chesterfield, Missouri, USA.
⁸³ Johns Hopkins Hospital, Division of Cardiology, Baltimore, Maryland, USA.
⁸⁴ Palomar Health Medical Group, Escondido, California, USA.
⁸⁵ Division of Cardiology, Rooney Heart Institute at NCH Healthcare System, Naples, Florida, USA.
⁸⁶ HCA Florida Northside Hospital, St Petersburg, Florida, USA.
⁸⁷ UPMC Heart and Vascular Institute, UPMC Hamot, Erie, Pennsylvania, USA.
⁸⁸ Aurora Cardiovascular and Thoracic Services, Aurora Sinai/Aurora St Luke's Medical Centers, Milwaukee, Wisconsin, USA.
⁸⁹ North Mississippi Medical Center, Tupelo, Mississippi, USA.
⁹⁰ PIH Good Samaritan Hospital, Los Angeles, California, USA.
⁹¹ Eastern Idaho Regional Medical Center, Idaho Falls, Idaho, USA.
⁹² Winchester Cardiology and Vascular Medicine, Winchester, Virginia, USA.
⁹³ University of Minnesota, Minneapolis VA Medical Center, Minneapolis, Minnesota, USA.
⁹⁴ Medical Center of the Rockies, Loveland, Colorado, USA.
⁹⁵ Community Heart and Vascular Hospital, Indianapolis, Indiana, USA.
⁹⁶ Colorado Heart and Vascular, Lakewood, Colorado, USA.
⁹⁷ Holy Cross Health, Fort Lauderdale, Florida, USA.
⁹⁸ Corewell William Beaumont University Hospital, Royal Oak, Michigan, USA.
⁹⁹ Morristown Medical Center, Morristown, New Jersey, USA.
¹⁰⁰ University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.
¹⁰¹ University of Texas Southwestern Medical Center, Dallas, Texas, USA.
¹⁰² Huntington Memorial Hospital, Pasadena, California, USA.
¹⁰³ HCA Healthcare West Florida Division, Tampa, Florida, USA.
¹⁰⁴ Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: vivek.reddy@mountsinai.org.

PMID: 41389071
DOI: 10.1016/j.jacc.2025.10.051

Multicenter Study

Multicenter Study on the Safety of Pulsed Field Ablation in Over 40,000 Patients: MANIFEST-US

Mohit K Turagam et al. J Am Coll Cardiol. 2026.

. 2026 Jan 20;87(2):172-193.

doi: 10.1016/j.jacc.2025.10.051. Epub 2025 Nov 10.

Authors

Affiliations

¹ Icahn School of Medicine at Mount Sinai, New York, New York, USA.
² Mercy General Hospital, Sacramento, California, USA.
³ St Mark's Hospital HCA Healthcare, Salt Lake City, Utah, USA.
⁴ MercyOne Iowa Heart Center, West Des Moines, Iowa, USA.
⁵ St Bernard's Medical Center, Jonesboro, Arkansas, USA.
⁶ Texas Cardiac Arrhythmia Institute, St David's Medical Center, Austin, Texas, USA.
⁷ Christus Trinity Mother Frances Health System, Tyler, Texas, USA.
⁸ Weill Cornell Medicine/New York Presbyterian Hospital, New York, New York, USA.
⁹ NYU Langone Health, New York, New York, USA.
¹⁰ Trident Medical Center, Charleston, South Carolina, USA.
¹¹ St Luke's Medical Center, Boise, Idaho, USA.
¹² Frederik Meijer Heart and Vascular Institute, Corewell Health West, Grand Rapids, Michigan, USA.
¹³ Northside Hospital Cardiovascular Institute, Sandy Springs, Georgia, USA.
¹⁴ Overlake Medical Center, Bellevue, Washington, USA.
¹⁵ Cardiovascular Specialists of New England, Manchester, New Hampshire, USA.
¹⁶ Endeavor Health, Glenview, Illinois, USA.
¹⁷ University of Colorado, Colorado Springs, Colorado, USA.
¹⁸ Pima Heart Physicians, PC, Tucson, Arizona, USA.
¹⁹ Brigham and Women's Hospital, Boston, Massachusetts, USA.
²⁰ Texas Cardiac Arrhythmia Dallas, Dallas, Texas, USA.
²¹ Oklahoma Heart Institute, Tulsa, Oklahoma, USA.
²² AdventHealth Orlando, Orlando, Florida, USA.
²³ Cedars Sinai Smidt Heart Institute, Los Angeles, California, USA.
²⁴ Prisma Health, Columbia, South Carolina, USA.
²⁵ HCA Florida Bayonet Hospital, Hudson, Florida, USA.
²⁶ WellSpan Health, York, Pennsylvania, USA.
²⁷ AdventHealth Porter, Denver, Colorado, USA.
²⁸ The Arrhythmia Center of South Florida, Delray Beach, Florida, USA.
²⁹ Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
³⁰ AdventHealth Tampa, Tampa, Florida, USA.
³¹ University of Colorado Anschutz Campus, Aurora, Colorado, USA.
³² Georgia Heart Institute, Northeast Georgia Health System, Gainesville, Georgia, USA.
³³ AdventHealth Shawnee Mission, Merriam, Kansas, USA.
³⁴ Aurora St Luke's Medical Center, Milwaukee, Wisconsin, USA.
³⁵ HCA Florida Sarasota Doctors Hospital, Sarasota, Florida, USA.
³⁶ Penn Medicine Lancaster General Health, Lancaster, Pennsylvania, USA.
³⁷ University of Chicago Medicine, Chicago, Illinois, USA.
³⁸ Dignity Health Heart Arrhythmia Center, Chandler, Arizona, USA.
³⁹ Providence St Vincent Medical Center, Portland, Oregon, USA.
⁴⁰ Cardiac Electrophysiology Section, Cardiovascular Medicine Division, Department of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁴¹ Providence Santa Rosa Memorial Hospital, Santa Rosa, California, USA.
⁴² Department of Internal Medicine, St Joseph's Medical Center, Stockton, California, USA.
⁴³ Central Maine Medical Center, Lewiston, Maine, USA.
⁴⁴ Emory University School of Medicine, Atlanta, Georgia, USA.
⁴⁵ Pacific Heart Institute, Santa Monica, California, USA.
⁴⁶ Advocate Aurora Research Institute, Advocate Aurora Health, Milwaukee, Wisconsin, USA.
⁴⁷ University of Missouri-Columbia, Columbia, Missouria, USA.
⁴⁸ Medical University of South Carolina, Columbia, South Carolina, USA.
⁴⁹ Piedmont Heart of Buckhead Electrophysiology, Piedmont Heart Institute, Atlanta, Georgia, USA.
⁵⁰ Saint Luke's Mid-America Heart Institute, Kansas City, Missouri, USA.
⁵¹ Penn State Health Holy Spirit Medical Center, Camp Hill, Pennsylvania, USA.
⁵² Doylestown Hospital, Doylestown, Pennsylvania, USA.
⁵³ Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
⁵⁴ HCA Florida Citrus Hospital, Inverness, Florida, USA.
⁵⁵ Keck Medical Center of USC, Los Angeles, California, USA.
⁵⁶ University of California-San Diego, La Jolla, California, USA.
⁵⁷ Rush University Hospital, Chicago, Illinois, USA.
⁵⁸ Division of Cardiovascular Medicine, Department of Medicine, University of Arizona College of Medicine, Tucson, Arizona, USA.
⁵⁹ Medical University of South Carolina, Charleston, South Carolina, USA.
⁶⁰ PeaceHealth Sacred Heart Medical Center RiverBend, Springfield, Oregon, USA.
⁶¹ CHI Health Nebraska Heart Institute, Lincoln, Nebraska, USA.
⁶² Florida Heart and Vascular, Fort Lauderdale, Florida, USA.
⁶³ Henry Ford Health, Detroit, Michigan, USA.
⁶⁴ Northwestern University, Chicago, Illinois, USA.
⁶⁵ Department of Cardiology, Maine Medical Center, Portland, Maine, USA.
⁶⁶ Decatur Memorial Hospital, Decatur, Illinois, USA.
⁶⁷ Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.
⁶⁸ HCA Florida Blake Hospital, Bradenton, Florida, USA.
⁶⁹ Baptist Health System, Jacksonville, Florida, USA.
⁷⁰ HCA Florida Largo Hospital, Largo, Florida, USA.
⁷¹ Mount Sinai Morningside, New York, New York, USA.
⁷² Valley Health System, Paramus, New Jersey, USA.
⁷³ Piedmont Heart Institute, Athens, Georgia, USA.
⁷⁴ Cleveland Clinic, Cleveland, Ohio, USA.
⁷⁵ University of Michigan, Ann Arbor, Michigan, USA.
⁷⁶ French Hospital Medical Center, San Luis Obispo, California, USA.
⁷⁷ Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas, USA.
⁷⁸ Bay Area Cardiology, Tampa, Florida, USA.
⁷⁹ Grandview Medical Center, Birmingham, Alabama, USA.
⁸⁰ Northwestern Medicine, Palos Hospital, Palos Heights, Illinois, USA.
⁸¹ The University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
⁸² St Luke's Hospital, Chesterfield, Missouri, USA.
⁸³ Johns Hopkins Hospital, Division of Cardiology, Baltimore, Maryland, USA.
⁸⁴ Palomar Health Medical Group, Escondido, California, USA.
⁸⁵ Division of Cardiology, Rooney Heart Institute at NCH Healthcare System, Naples, Florida, USA.
⁸⁶ HCA Florida Northside Hospital, St Petersburg, Florida, USA.
⁸⁷ UPMC Heart and Vascular Institute, UPMC Hamot, Erie, Pennsylvania, USA.
⁸⁸ Aurora Cardiovascular and Thoracic Services, Aurora Sinai/Aurora St Luke's Medical Centers, Milwaukee, Wisconsin, USA.
⁸⁹ North Mississippi Medical Center, Tupelo, Mississippi, USA.
⁹⁰ PIH Good Samaritan Hospital, Los Angeles, California, USA.
⁹¹ Eastern Idaho Regional Medical Center, Idaho Falls, Idaho, USA.
⁹² Winchester Cardiology and Vascular Medicine, Winchester, Virginia, USA.
⁹³ University of Minnesota, Minneapolis VA Medical Center, Minneapolis, Minnesota, USA.
⁹⁴ Medical Center of the Rockies, Loveland, Colorado, USA.
⁹⁵ Community Heart and Vascular Hospital, Indianapolis, Indiana, USA.
⁹⁶ Colorado Heart and Vascular, Lakewood, Colorado, USA.
⁹⁷ Holy Cross Health, Fort Lauderdale, Florida, USA.
⁹⁸ Corewell William Beaumont University Hospital, Royal Oak, Michigan, USA.
⁹⁹ Morristown Medical Center, Morristown, New Jersey, USA.
¹⁰⁰ University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.
¹⁰¹ University of Texas Southwestern Medical Center, Dallas, Texas, USA.
¹⁰² Huntington Memorial Hospital, Pasadena, California, USA.
¹⁰³ HCA Healthcare West Florida Division, Tampa, Florida, USA.
¹⁰⁴ Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: vivek.reddy@mountsinai.org.

PMID: 41389071
DOI: 10.1016/j.jacc.2025.10.051

Abstract

Background: Pulsed field ablation (PFA) is emerging as the preferred energy source for atrial fibrillation ablation, largely because of its promising safety profile, including lower risks of esophageal injury, pulmonary vein stenosis, and phrenic nerve injury. However, rare complications may only emerge after treating many thousands of patients.

Objectives: This study sought to determine the real-world utilization and safety profile of the pentaspline PFA catheter in the United States.

Methods: In this retrospective analysis, invitations were sent to U.S. centers performing PFA with the pentaspline catheter. Centers submitted data on patient demographics, procedural details, and adverse events (AEs). The main outcomes included the incidence of major and minor procedure-related AEs.

Results: Of the 435 centers contacted, 102 participated, averaging 5.1 operators per center (range 1-16 operators per center). Each center treated a median of 412 patients (range 26-1,961 patients), totaling 41,968 patients between February 2024 and July 2025. The median patient age was 68 years (range 17-99 years), and 56% were male. Most patients underwent first-time ablation (73%), primarily for paroxysmal (54%) or persistent atrial fibrillation (37%). Pulmonary vein isolation was performed in 93% of patients, with extravenous lesions on the posterior wall (57%), cavotricuspid isthmus (31%), or mitral isthmus (14%). Major AEs occurred in only 0.63% of patients, including cardiac tamponade (0.16%), vascular injury requiring intervention (0.18%), and stroke (0.10%). Importantly, no cases of esophageal fistula, persistent phrenic nerve paralysis, or pulmonary vein stenosis occurred. Mortality at 30 days was rare (0.04%), but there was a potential signal for rare (0.019%) unexplained sudden death/cardiac arrest. Rare AEs included coronary spasm (0.10%) and acute renal failure requiring dialysis (0.02%). Minor complications were reported in 2.05%, mainly vascular issues (0.96%), pericarditis (0.52%), and self-limited esophageal dysmotility (0.04%).

Conclusions: In a real-world setting of unselected U.S. patients, PFA demonstrated a safety profile consistent with preferentiality to functional myocardial tissue ablation, without evidence of esophageal fistula or pulmonary vein stenosis. The major complication rate was ∼0.6%-mostly vascular AEs and pericardial tamponade. Stroke (∼1 in 1,000) and death (∼1 in 2,000) were rare. These data indicate that the initial implementation of pentaspline PFA has been overall safe.

Keywords: atrial fibrillation; catheter ablation; pentaspline catheter; pulsed field ablation.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Turagam has served as a consultant to Abbott, Medtronic, and J&J MedTech. Dr Aryana has served as a consultant to/speaker for Abbott, Boston Scientific, Biotronik, Medtronic, and J&J MedTech. Dr Day has served as a consultant to/speaker for Boston Scientific and Abbott. Dr Dukkipati has received royalty payments from Boston Scientific; and has served as a consultant to Biosense-J&J MedTech and Boston Scientific. Dr Hounshell has served as a consultant to and on the advisory board of Boston Scientific. Dr Nair has served as a consultant to Biosense Webster, Boston Scientific Corporation, Johnson & Johnson, and Medtronic; and has received research grants from Abbott Laboratories, Adagio, Boston Scientific, Laminar, and Medtronic. Dr Natale has served as a consultant to Abbott, Biosense Webster, Biotronik, Boston Scientific, and iRhythm. Dr Weiner has served as a consultant to Abbott, Boston Scientific, Johnson and Johnson, and Medtronic; and has performed research for Bayer, Boston Scientific, Impulse Dynamics, Medtronic, Recor Medical, and V-Wave. Dr Cheung has served as a consultant to Biosense; has received research grant support from Boston Scientific; and has received fellowship grant support from Abbott, Biosense, Boston Scientific, and Medtronic. Dr Chinitz has received speaker fees from and served as a consultant to Abbott, Biotronik, Medtronic, and Biosense Webster. Dr Cuoco has served as a consultant to and performed research for Boston Scientific and Abbott. Dr Daccarett has served as a consultant to Boston Scientific. Dr Gambhir has received consulting fees from Abbott, Biosense Webster, and Boston Scientific; and has received speaker fees from Boston Scientific. Dr Gandhavadi has served as a speaker/consultant for Abbott, Medtronic, Boston Scientific, and Haemonetics. Dr Kim has received honoraria from Boston Scientific and Biosense Webster. Dr Metzl has served as a consultant for Atraverse, J&J MedTech, and Boston Scientific. Dr Mikaelian has served as a consultant for Boston Scientific and Johnson and Johnson. Dr Romero has received consulting fees from J&J MedTech, Boston Scientific, Abbott, AtriCure, and Sanofi; and has received research funding from Medtronic, J&J MedTech, and Boston Scientific. Dr Shaik has relationships with Boston Scientific, Medtronic, Abbott, Biotronik, Biosense Webster, and Agra Medical. Dr Shehata has received research grants from and served as a consultant to Boston Scientific and Abbott. Dr Siddique has served as a consultant to Boston Scientific. Dr Singleton has served as a consultant to Abbott, Biosense Webster, Boston Scientific, Haemonetics, and Medical Device Business Services. Dr Sundaram has served as a consultant to and on the Speakers Bureau of Medtronic, Abbott, and Boston Scientific; and holds equity interest in and serves on the Advisory Board of Heart Hero. Dr Vivas has served as a consultant for Abbott and Boston Scientific. Dr Waks previously served on the Advisory Board for Heartcor Solutions LLC; has served as a consultant to HeartBeam Inc and Heartcor Solutions LLC; and has received research funding from Anumana. Dr Zipse has served as a consultant to or on the Advisory Boards of Medtronic, Biosense Webster, and Philips; and has received honoraria for Fellow Education Lectures from Boston Scientific. Dr Ali has served as a speaker for Medtronic. Dr Bansal has served as a consultant to Medtronic and Johnson and Johnson. Dr Beaser has served as a speaker for Abbott. Dr Callans has consulted and lectured for Boston Scientific. Dr Chothia has served as a consultant to a Medtronic pacemaker implant training site. Dr DeLurgio has served as a consultant to/speaker for Boston Scientific. Dr Doshi has served as a consultant to/on the Advisory Boards of Abbott, Boston Scientific, and J&J MedTech. Dr Goyal has relationships with Medtronic, Boston Scientific, Abbott, and Siemens. Dr Gupta has received modest consulting/teaching honoraria from Boston Scientific, Abbott, and Cordis. Dr Hennessey has served as a consultant to and speaker for Boston Scientific; has served as a consultant to and educational speaker for Abbott; and has served on the Advisory Board of Medtronic. Dr Hsu has received honoraria from Medtronic, Abbott, Boston Scientific, Biotronik, Janssen Pharmaceuticals, Bristol Myers Squibb, Pfizer, Sanofi, Altathera Pharmaceuticals, Milestone Pharmaceuticals, Zoll Medical, iRhythm, Edwards Lifesciences, Viz.ai, Atraverse Medical, and Biosense Webster; and holds equity interest in Vektor Medical. Dr Huang has received a research grant and speaker honorarium from and served as a consultant to Biosense Webster. Dr Kaplan has served as a consultant to Abbott, Boston Scientific, and Medtronic; and has received royalties from UptoDate. Dr Kenigsberg has served as Chief Medical Officer for Electrophysiology of Pulse Biosciences; has served as a consultant to Abbott and Johnson and Johnson; and is a shareholder in Cortex. Dr Knight has served as a consultant to Abbott, Atraverse, Baylis, Biosense Webster, Biotronik, Boston Scientific, iRhythm, and Medtronic. Dr Leyton-Mange has served as a consultant to Biosense Webster and Heart Rhythm Clinical Research Solutions. Dr Maglione has received honorarium from Biosense Webster. Dr Mittal has served as a consultant to Boston Scientific and Medtronic. Dr Nilsson has relationships with Abbott and Biosense Webster. Dr Omotoye has served as a consultant to Biosense Webster and Attune Medical. Dr Oral is a member of the Scientific Advisory Board of Arga Medtech. Dr Patel has served as a speaker for/consultant to Biosense Webster. Dr Rajendra has served as a consultant to Boston Scientific, J&J MedTech EP, and CardioFocus. Dr Razminia has served as a consultant to Abbott and Boston Scientific. Dr Saba has received research support from Abbott and Boston Scientific; and has served as a consultant to Boston Scientific and Medtronic. Dr Sharma has served as a consultant to Medtronic, Boston Scientific, and Abbott. Dr Tholakanahalli has served as a consultant to Boston Scientific, Abbott Inc, J&J Med Tech, Imricor, Caylan, Aquaheart, Kobara Corp, Hicky Inc, and Patvja LLC. Dr Trivedi has served as a consultant to Medtronic and Abbott. Dr Trulock has served as a consultant/advisor for Boston Scientific, Medtronic, and Abbott. Dr Winters has performed research for Biosense Webster. Dr Wright has served as a consultant to/speaker for J&J MedTech. Dr Aizer has served as a consultant to Biotronik and Ulysses Medical. Dr Alyesh has served as a consultant to Abbott Laboratories, J&J MedTech, and Heart Rhythm Clinical Research Solutions. Dr Amado has served as a consultant to Boston Scientific. Dr Chalfoun has served as a speaker for Medtronic and Boston Scientific; and has served as a speaker for and consultant to Atricure. Dr Chang has received honoraria from Boston Scientific and Biosense Webster. Dr Michaud has served as a consultant to Abbott, Arrhythmia Education Inc, J&J MedTech, Boston Scientific, and HMP Education. Dr Mora has served as a consultant to Abbott and Boston Scientific. Dr Mounir has served as a consultant to Biosense Webster. Dr Sauer has received consulting fees from J&J MedTech, Boston Scientific, and Abbott; and has received research funding from Medtronic and J&J Med Tech. Dr Tzou has received consulting fees, speaker honoraria, or grant funding from or served on Advisory Boards for Abbott, Biosense Webster, Boston Scientific, Biotronik, Kardium, and Medtronic. Dr Sidney has served as a consultant to and performed research for Boston Scientific and Abbott. Dr Reddy has received grant support from and is an unpaid consultant to Boston Scientific; has served as a consultant for and has equity in Anumana, APN Health, Append Medical, Aquaheart, Atacor, Atraverse, Autonomix, BioSig, CardiaCare, Cardiofocus, CardioNXT/AFTx, Circa Scientific, CoRISMA, Cortex-Boston Scientific, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EP Frontiers, Field Medical, Focused Therapeutics, Heartbeam, HRT, Intershunt, Javelin, Kardium, Laminar-J&J MedTech, LuxMed, Medlumics, Orchestra Biomed, PhysioMap, Pulse Biosciences, Restore Medical, Sirona Medical, SoundCath-Boston Scientific, and Volta Medical (unrelated to this manuscript); has served as a consultant to Abbott, Adagio Medical, AtriAN, BioTel Heart, Biotronik, BTL, Cairdac, Cardionomic, Conformal Medical, CoreMap, Fire1, Impulse Dynamics, J&J MedTech, Medtronic, Novartis, Novo Nordisk, Philips, and SmartValves (unrelated to this work); and has equity in DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Soundcath, Surecor, and Vizaramed (unrelated to this work). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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Multicenter Study on the Safety of Pulsed Field Ablation in Over 40,000 Patients: MANIFEST-US

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Multicenter Study on the Safety of Pulsed Field Ablation in Over 40,000 Patients: MANIFEST-US

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