Continuing to redefine standards in stroke prevention and atrial fibrillation (AF) management, Montefiore Einstein’s electrophysiology (EP) and arrhythmia management team, led by Prof Luigi Di Biase, MD, PhD, Section Head of Electrophysiology and Professor of Medicine (Cardiology) at Montefiore Einstein, and Xiaodong (Andy) Zhang, MD, PhD, was among the first in the nation to perform concurrent pulsed field ablation (PFA) for AF ablation and left atrial appendage occlusion (LAAO) for stroke prevention as a combined approach this past year. 

Our EP group comprises thought leaders in the field of arrhythmia stroke prevention, who have been involved in the development and research of both PFA and LAAO. We were among a few centers nationwide to participate in the U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) clinical trials that led to the development and FDA approval of PFA devices this past year, such as the VARIPULSE platform—FDA approved in November 2024—and the PulseSelect PFA system—the first FDA-approved PFA system in December 2023. As top centers in the US, we also routinely use the FARAPULSE PFA device as well as the Affera system. We also pioneered the method of left atrial appendage isolation and developed a comprehensive left atrial appendage closure device program. Percutaneous LAAO reduces the risk of stroke by closing the muscular pouch where clots form.

Offering potential advantages for the combined approach, PFA has been shown to be an efficient and potentially safer option compared to traditional thermal ablation techniques, allowing more patients to be treated. Percutaneous LAAO has also been shown to reduce the risk of AF-related strokes in patients with comorbidities that may preclude oral anticoagulation therapy, such as high risk of bleeding, low compliance to medications, frailty and high risk of falls.

With technological advancements that have enhanced the safety and efficiency of LAAO and pulmonary vein isolation (PVI) through PFA, the combined PFA-based AF ablation and LAAO approach in managing individuals with AF is extremely appealing. 

With the recent Centers for Medicare and Medicaid Services (CMS) approval for concomitant PFA and LAAO procedures, Dr. Di Biase and his EP team recently performed one of the first commercial cases with this new approach at Montefiore Einstein. 

We’re ranked in the top 1% of all hospitals in the nation for cardiology, heart and vascular surgery according to U.S. News & World Report, and we are an international referral site for the most complex cases. Montefiore Einstein’s leadership in these innovative procedures reflects our commitment to clinical excellence and groundbreaking research. By pioneering combined PFA-based AF ablation and LAAO treatment, we continue to redefine standards in stroke prevention and AF management.