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Left Bundle Branch Area Stylet-Driven Lead: Performance, Safety and Quality of Life at 12 Months Post Implant (The BIO-CONDUCT IDE Study)

Liu, Christopher F; Prasad, Karthik Venkatesh; Moretta, Antonio; Goldstein, Matthew A; Vijayaraman, Pugazhendhi; Gleva, Marye; Chinitz, Larry A; ,
BACKGROUND:Prospective studies with a focus on the safety and effectiveness profile of stylet-driven left bundle branch area pacing (LBBAP) leads at both implant and chronic stages significantly contribute to a comprehensive perspective of utilizing SDL in this pacing modality. OBJECTIVE:Prospectively evaluate the performance and safety of LBBA-placed Solia S leads and the related impact on the patient's quality of life (QOL) through 12 months. METHODS:A multi-center, prospective, non-randomized trial enrolled patients with standard pacing indications in whom a Solia S lead was implanted in the left bundle branch area (LBBA). Adverse events and quality-of-life metrics were collected out to 12 months post implant along with threshold, sensing, and lead impedance data. RESULTS:For the 161 patients who experienced an SADE event or had at least 335 days of follow-up, the associated 12-month serious adverse device effect (SADE) rate was 0.02 events per subject-year [SADE-free rate of 98.1% (95% CI: 94.7%, 99.6%)]. The mean threshold was 0.98V at 0.4ms (vs. 0.84V at implant), mean sensing was 12.76mV (vs. 9.15mV at implant), and mean impedance was 521.8 ohms (vs. 670.5 ohms at implant). The mean change for the QOL physical function scale was +11.4 ± 24.0 (95% CI: 7.4, 15.4; t-value = 4.23; p < 0.001). CONCLUSION/CONCLUSIONS:These 12-month results utilizing the Solia S SDL demonstrate freedom from LBBAP lead-related complications, acceptable lead performance characteristics along with a significant coincident improvement in a patient's physical function.
PMID: 41864302
ISSN: 1556-3871
CID: 6017242

To Ablate or Wait?: Navigating the Potential Risk of Urgent Inpatient Atrial Fibrillation Ablation [Editorial]

Santucci, John; Chinitz, Larry A
PMID: 41823942
ISSN: 2405-5018
CID: 6016052

Electrogram Frequency Analysis and Isochronal Activation Surface Area Mapping for Ablation of Premature Ventricular Contractions

Hoffer-Hawlik, Michael A; Pradhan, Alyna; Rosinski, Elizabeth; Jankelson, Lior; Kushnir, Alexander; Garber, Leonid; Holmes, Douglas; Aizer, Anthony; Chinitz, Larry A; Barbhaiya, Chirag R
INTRODUCTION/BACKGROUND:A lower frequency early electrogram (EGM) or broad area of early activation during premature ventricular contraction (PVC) mapping may be associated with a PVC origin in an opposing chamber or deep within the mapped surface. The utility of quantifying EGM frequency at early activation sites and isochronal activated surface area (IASA) is unclear. Our study aimed to investigate the utility of EGM frequency analysis and IASA mapping to complement activation mapping during PVC ablation. METHODS:High density PVC activation and IASA maps were created using a multi-electrode mapping catheter in 25 patients undergoing PVC ablation. EGMs in early activation regions were retrospectively studied. IASAs in each mapped chamber were analyzed. RESULTS:within 10 ms was unsuccessful. CONCLUSION/CONCLUSIONS:Higher EGM frequency and smaller IASA were associated with successful ablation of PVCs. Ablation at sites with EGM frequency > 325 Hz was successful in all patients. The utility of identifying higher frequency EGMs at early activation sites requires further study.
PMID: 41755355
ISSN: 1540-8167
CID: 6010472

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

Left atrial wall thickness correlates with pulmonary vein reconnection following atrial fibrillation ablation

Kushnir, Alexander; Barbhaiya, Chirag R; Jankelson, Lior; Holmes, Douglas; Aizer, Anthony; Park, David; Bernstein, Scott; Spinelli, Michael A; Garber, Leonid; Yang, Felix; Rosinski, Elizabeth; Chinitz, Larry A
BACKGROUND:Pulmonary vein (PV) isolation is the cornerstone of radiofrequency (RF) ablation for atrial fibrillation (AF) and PV reconnection is a common cause of recurrent AF. The relationship between PV ostial wall thickness (WT) and durable PV isolation is a matter of ongoing investigation. Additionally, the relationship between catheter impedance and WT is not well understood. We studied the relationship between PV ostial WT, ablation lesion metrics, and PV reconnection. METHODS:16 patients were identified who underwent an initial and redo AF ablation procedure and had a cardiac CTA analyzed using ADAS-3D imaging software performed prior to the initial ablation. Ablation lesion metrics from the initial ablation procedure were collected from the electroanatomic mapping software. Reconnected and isolated PV were identified based on electroanatomic mapping data collected at the redo AF ablation procedure. Patients with reconnected PV exhibited thicker left atrial walls (1.4 mm vs 1.2 mm, P < 0.05) and reconnected veins exhibited thicker ostial walls (1.7 mm, vs 1.5 mm, P < 0.05). LA volume, number of ablation lesions, and ablation lesion time were not significantly different between reconnected and isolated PV. Impedance drop during ablation was greater in patients with reconnected PV compared to patients with isolated PV (- 9.0 Ω vs - 6.6 Ω, P < 0.05). There was no correlation between PV ostial WT and ablation lesion impedance drop. CONCLUSION/CONCLUSIONS:PV reconnection was associated with thicker LA and PV ostial WT. Future studies will examine whether targeting thicker PV ostial tissue with more aggressive lesion metrics or different ablation technology can improve PV isolation and ablationoutcomes.
PMID: 40542289
ISSN: 1572-8595
CID: 5871412

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

Improved spatial stability with a flexible tip ablation catheter in atrial fibrillation ablation

Hoffer-Hawlik, Michael A; Jankelson, Lior; Rosinski, Elizabeth; Huo, Yan; Shai, Isaac; Aizer, Anthony; Holmes, Douglas; Chinitz, Larry A; Barbhaiya, Chirag R
PMCID:12570199
PMID: 41169970
ISSN: 2666-5018
CID: 5961712

Personalized Ablation Strategies Optimize First Pass Isolation and Minimize Pulmonary Vein Reconnection During Paroxysmal Atrial Fibrillation Ablation

Junarta, Joey; Qiu, Jessica; Cheng, Austin V; Barbhaiya, Chirag R; Jankelson, Lior; Holmes, Douglas; Kushnir, Alexander; Knotts, Robert J; Yang, Felix; Bernstein, Scott A; Park, David S; Chinitz, Larry A; Aizer, Anthony
PMID: 39447812
ISSN: 1556-3871
CID: 5740132

Novel algorithm for fully automated rapid and accurate high definition electrogram acquisition for electroanatomical mapping [Letter]

Tarabanis, Constantine; Segev, Meytal; Weiss, Shaked; Chinitz, Larry; Jankelson, Lior
PMID: 37853261
ISSN: 1572-8595
CID: 5736102