Multicenter Study on the Safety of Pulsed Field Ablation in Over 40,000 Patients: MANIFEST-US
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; ,
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/OBJECTIVE: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.
PMID: 41389071
ISSN: 1558-3597
CID: 5978212
Vein of Marshall Ethanol Ablation as a Strategy for Recurrent Persistent Atrial Fibrillation
Hsia, Brian C; Zhang, Peter; Junarta, Joey; Garber, Leonid; Yang, Felix; Spinelli, Michael; Malyshev, Yury; Kushnir, Alexander; Jankelson, Lior; Bernstein, Scott; Park, David; Barbhaiya, Chirag; Holmes, Douglas; Chinitz, Larry A; Aizer, Anthony
BACKGROUND:Vein of Marshall (VOM) ethanol ablation is effective in preventing recurrence in patients with persistent atrial fibrillation (AF) as a de novo strategy. There is minimal data on its use in recurrent AF. OBJECTIVE:We investigated the efficacy of VOM ethanol ablation for recurrence despite initial AF ablation. METHODS:Retrospective analysis was performed of persistent AF patients who underwent repeat ablation after an initial ablation for persistent AF. All patients had pulmonary vein isolation (PVI), posterior wall isolation (PWI), and cavotricuspid isthmus (CTI) during their previous ablation(s). At redo ablation, controls underwent confirmation and completion of previous ablation steps, substrate modification, and a search for non-PV triggers. Cases had additional VOM ethanol ablation combined with mitral isthmus ablation. RESULTS:One hundred and seven patients (49 VOM, 60 control) were included. There was no difference in AF recurrence at 1-year comparing VOM patients (47%) and controls (38%), (p = 0.39). Within the VOM group, the mean AF burden decreased from 38% preablation to 10% 12-months post (p = 0.003). The proportion of recurrent persistent AF decreased from 65% preablation to 26% post (p = 0.004). There was no significant difference in reduction in AF burden or proportion of recurrent persistent AF when comparing VOM cases and controls. Six percent of VOM patients developed intraprocedural left atrial appendage (LAA) isolation. CONCLUSIONS:In patients with previous PVI, PWI, and CTI ablation, VOM ethanol ablation did not demonstrate a reduction in AF recurrence or burden when compared with a strategy of substrate modification and trigger ablation alone and increases the risk of LAA isolation.
PMID: 41017428
ISSN: 1540-8167
CID: 5976972
Artificial intelligence-enabled sinus electrocardiograms for the detection of paroxysmal atrial fibrillation benchmarked against the CHARGE-AF score
Tarabanis, Constantine; Koesmahargyo, Vidya; Tachmatzidis, Dimitrios; Sousonis, Vasileios; Bakogiannis, Constantinos; Ronan, Robert; Bernstein, Scott A; Barbhaiya, Chirag; Park, David S; Holmes, Douglas S; Kushnir, Alexander; Yang, Felix; Aizer, Anthony; Chinitz, Larry A; Tzeis, Stylianos; Vassilikos, Vassilios; Jankelson, Lior
AIMS/UNASSIGNED:We aimed to develop and externally validate a convolutional neural network (CNN) using sinus rhythm electrocardiograms (ECGs) and CHARGE-AF features to predict incident paroxysmal atrial fibrillation (AF), benchmarking its performance against the CHARGE-AF score. METHODS AND RESULTS/UNASSIGNED:We curated 157 192 sinus ECGs from 76 986 patients within the New York University (NYU) Langone Health system, splitting data into training, validation, and test sets. Two cohorts, from suburban US outpatient practices and Greek tertiary hospitals, were used for external validation. The model utilizing the sinus ECG signal and all CHARGE-AF features achieved the highest test set area under the receiver operator curve (AUC) (0.89) and area under the precision recall curve (AUPRC) (0.69), outperforming the CHARGE-AF score alone. Model robustness was maintained in the external US cohort (AUC 0.90, AUPRC 0.67) and the European cohort (AUC 0.85, AUPRC 0.78). Subgroup analyses confirmed consistent performance across age, sex, and race strata. A CNN using ECG signals alone retained strong predictive ability, particularly when simulating missing or inaccurate clinical data. CONCLUSION/UNASSIGNED:Our CNN integrating sinus rhythm ECGs and CHARGE-AF features demonstrated superior predictive performance over traditional risk scoring alone for detecting incident paroxysmal AF. The model maintained accuracy across geographically and clinically diverse external validation cohorts, supporting its potential for broad implementation in AF screening strategies.
PMCID:12629645
PMID: 41267852
ISSN: 2634-3916
CID: 5976102