Multicenter Study on the Safety of Pulsed Field Ablation in Over 40,000 Patients: MANIFEST-US.
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Turagam Mohit K, Aryana Arash, Day John D, Dukkipati Srinivas R, Hounshell Troy, Nair Devi, Natale Andrea, Weiner Stanislav, Cheung Jim W, Chinitz Larry, Cuoco Frank, Daccarett Marcos, Dandamudi Sanjay, Gambhir Alok, Gandhavadi Maheer, Kim Jamie, Metzl Mark D, Mikaelian Bradley, Peress Darren, Romero Jorge E, Sanchez Javier, Sandler David A, Shaik Naushad A, Shehata Michael, Siddique Sultan M, Singh Abhinav, Singleton Matthew J, Sundaram Sri, Vivas Yoel, Waks Jonathan W, Yamamura Kenneth H, Zipse Matthew, Ahn Joon, Al Chekakie Obadah, Ali Mahmoud, Ascandar Nameer, Bansal Sandeep, Beaser Andrew D, Bisla Jaskanwal, Brancato Scott, Callans David J, Chang-Sing Peter, Chothia Rashaad, Dell'Orfano Joseph, DeLurgio David B, Doshi Shephal K, Erickson Lynn, Gautam Sandeep, Gottipaty Venkateshwar, Goyal Sandeep, Gupta Sanjaya, Hajjari Jamal, Harding John D, Hennessey Jessica, Ho Huy, Ho Ivan, Hsu Jonathan C, Huang Henry D, Hutchinson Matthew, Kaplan Rachel, Karanam Sreekanth, Kaushik Nayanjyoti, Kenigsberg David N, Khan Arfaat, Knight Bradley, Leyton-Mange Jordan, Lim Bernard, Maglione Theodore J, Malik Bobby, McKillop Matthew, Mehlhorn Donald, Mehta Davendra, Mittal Suneet, Nilsson Kent R, Omotoye Samuel, Oral Hakan, Panikkath Ragesh, Patel Apoor, Perzanowski Christian, Rajendra Anil, Razminia Mansour, Saba Samir, Sanchez Jose M, Satti Danish Iltaf, Sawhney Navinder, Sharma Dinesh, Sheppard Robert, Singh Madhurmeet, Sra Jasbir, Stone James E, Sureddi Ravi, Taylor Matthew, Teigeler Todd L, Tholakanahalli Venkat, Trivedi Amar, Trulock Kevin M, Venkataraman Ganesh, Weitz Daniel, Williamson Brian D, Winters Stephen L, Wright Jennifer M, Wu Richard, Yoo David, Aizer Anthony, Alyesh Daniel Dan, Amado Luciano, Borne Ryan, Chalfoun Nagib, Chang David, Davis Megan, Ehdaie Ashkan, Gerczuk Paul Z, Lee Jefferson H, Michaud Gregory, Miyama Hiroshi, Mohanty Sanghamitra, Mora Luis, Mounir George, Nannapaneni Nischala, Nazari Jose, Peigh Graham, Sauer William H, Sidney Darren, Varughese Vivek, Tzou Wendy, Gurol Ugur, Reddy Vivek Y, MANIFEST-US Investigators
Аннотация
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.