Safety, Efficacy, and Effectiveness of Pulsed Field Ablation with Farapulse™ to Treat Atrial Fibrillation: A Prospective Single-center Study

DOI: 10.19102/icrm.2026.17096

DEAN SABAYON, MD,¹ DEAA ABU JAZAR, MD,¹ KHALED ALABDALLAH, MD,¹ RITIKA SAXENA, MPH,¹ IVANA GARZA, MD,¹ ARUN NARAYANAN, MD,¹ HAIDAR AL TAII, MD,¹ DUSTIN STALOCH, MD,¹ and HANI JNEID, MD¹

¹Cardiovascular Disease Department, The University of Texas Medical Branch, Galveston, TX, USA

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ABSTRACT. Pulsed field ablation (PFA) using the Farapulse™ system (Boston Scientific, Marlborough, MA, USA) is a novel, non-thermal ablation technology developed to treat atrial fibrillation (AF) with improved safety and procedural efficiency. We present prospective single-center data on the safety, efficacy, and effectiveness of PFA in a real-world patient population. We enrolled 100 consecutive patients with symptomatic AF undergoing catheter ablation with the Farapulse™ system. Procedural characteristics, clinical outcomes, and acute safety events were evaluated. Freedom from AF recurrence was assessed at 6 months. The cohort had a mean age of 69.2 ± 10.9 years, and 47% were women. Pulmonary vein isolation was achieved in 96% of patients, with additional posterior wall ablation performed in 66%. The median procedure and fluoroscopy times were 42 and 12 min, respectively. No major adverse events occurred. At 6 months, 82% of patients were free from atrial arrhythmia recurrence off anti-arrhythmic drugs. PFA with the Farapulse™ system demonstrated high acute efficacy, excellent safety, and promising short-term effectiveness in a real-world population with AF. These findings support the broader adoption of PFA in routine clinical practice.

KEYWORDS. Atrial fibrillation, Farapulse, pulmonary vein isolation, pulsed field ablation.

The authors report no conflicts of interest for the published content. No funding information was provided.
Manuscript received January 24, 2026. Final version accepted May 1, 2026.
Address correspondence to: Khaled Alabdallah, MD, 18833 Town Ridge Lane, Apt. 2309, Webster, TX, 77598, USA. Email: khalabda@utmb.edu.

Introduction

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia worldwide and is associated with an increased risk of thromboembolic events, heart failure, and mortality. Catheter ablation has become an established therapy for symptomatic AF, with pulmonary vein isolation (PVI) serving as the cornerstone of the procedure due to the central role of pulmonary vein triggers in the initiation and maintenance of AF. Contemporary clinical guidelines and expert consensus documents support catheter ablation as an effective rhythm-control strategy for appropriately selected patients with AF.^1–3

Conventional ablation techniques, including radiofrequency and cryoballoon ablation, rely primarily on thermal energy to achieve myocardial tissue injury. While these approaches have demonstrated efficacy, they may be associated with collateral injury to adjacent structures such as the esophagus, phrenic nerve, and pulmonary veins.^4,5

Pulsed field ablation (PFA) is an emerging energy modality that uses high-voltage electrical fields to induce myocardial cell death through irreversible electroporation. This process creates nanopores in the cell membrane, leading to loss of cellular homeostasis and subsequent cell death.^6,7 Irreversible electroporation preferentially affects myocardial tissue while relatively sparing surrounding structures such as the esophagus, phrenic nerve, and pulmonary veins. Although electroporation is the primary mechanism of action, limited thermal effects may occur. Preclinical and early clinical studies have demonstrated the myocardial selectivity of electroporation and suggested a favorable safety profile while maintaining effective PVI.^8–10

The Farapulse™ system (Boston Scientific, Marlborough, MA, USA) represents one of the first commercially available PFA platforms to be adopted in clinical practice. In this study, we report prospective real-world data from a single high-volume center evaluating procedural outcomes, safety, and 6-month effectiveness of PFA-guided ablation using the Farapulse™ system.

Methods

Study population

We prospectively enrolled 100 consecutive patients with symptomatic paroxysmal or persistent AF undergoing ablation using the Farapulse™ PFA system. Procedures were performed by three experienced electrophysiology operators at our center. Data were collected on baseline demographics, comorbidities, echocardiographic characteristics, procedural metrics, safety outcomes, and post-procedural arrhythmia recurrence (Tables 1–3).

This study was approved by an institutional review board (human studies committee or ethics committee or animal care and use committee). Verbal and written consent was obtained as per University of Texas Medical Branch protocol.

Effectiveness outcomes

Follow-up protocol. All patients underwent standardized follow-up, including clinical evaluations, 12-lead electrocardiography, and 24-h Holter monitoring at 3 and 6 months post-ablation. Additional monitoring with event recorders was used in patients reporting symptoms suggestive of arrhythmia recurrence. Anti-arrhythmic drug therapy was discontinued post-ablation at the discretion of the treating electrophysiologist.

At 6-month follow-up, 82% (82/100) of patients remained free from any documented recurrence of atrial arrhythmias—including AF, atrial flutter, or atrial tachycardia lasting >30 s—off anti-arrhythmic medications. Arrhythmia recurrence was observed in 18 patients, including seven with paroxysmal AF, eight with persistent AF, and three with long-standing persistent AF.

Most recurrences occurred during the 3-month blanking period; however, 12 patients experienced late recurrences (>90 days post-ablation). No patients developed pro-arrhythmic complications such as organized atrial flutter attributable to ablation lesions.

Within the first 3 months, 16.2% (16/99) of patients presented to the emergency department or were hospitalized for PFA-related complications or recurrent AF. Among the 12 hospitalizations with documented reasons, nine (75%) were due to AF and three (25%) were due to pericarditis; there were no cases of pericardial tamponade or stroke. Cardioversion was performed in 8.2% (8/97) of patients within 3 months.

Left ventricular ejection fraction (LVEF) at 3 months was available in 41 patients. Among these, 39.0% had an LVEF of 55%–60%, 19.5% had that of 50%–55%, and 12.2% had that of 60%–65%, respectively. Reduced LVEF was present in a minority of patients, with 7.3% having an LVEF of 20%–25%. Data on LVEF were missing in 59% of patients.

At 6 months, 7.4% (7/95) of patients were hospitalized for cardiovascular events, including AF (n = 3, 42.9%) and heart failure exacerbation (n = 4, 57.1%), with no hospitalizations for stroke. At 12 months, 5.7% (4/70) of patients were hospitalized, all due to heart failure exacerbation. No stroke or AF-related hospitalizations were reported during this period.

Discussion

This study confirms that PFA using the Farapulse™ system is a highly effective and safe method for treating a broad spectrum of patients with AF. Our 6-month freedom from atrial arrhythmia of 82% without anti-arrhythmic medications is consistent with or superior to contemporary thermal ablation techniques, particularly given the inclusion of patients with persistent and long-standing AF.

Posterior wall ablation was performed in a subset of patients with both paroxysmal and persistent AF. In patients with persistent AF, posterior wall ablation was performed at the operator’s discretion. In patients with paroxysmal AF, posterior wall ablation was performed primarily in the setting of recurrent procedures and was guided by findings from three-dimensional electroanatomic mapping.

Following the procedure, patients were monitored for a short observation period and were routinely discharged on the same day. Anti-arrhythmic medications were discontinued immediately after the ablation procedure as part of the post-ablation management protocol.

Notably, this outcome was achieved with a very low complication rate and short procedure times. The nature of PFA likely contributes to this safety profile by reducing risks of esophageal injury, phrenic nerve damage, and pulmonary vein stenosis.

Conclusion

In a prospective, single-center cohort, PFA with the Farapulse™ system demonstrated high procedural success, excellent safety, and strong effectiveness at 6 months. These findings support the use of PFA as a front-line ablation approach in patients with AF.

References

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