Doylestown Health Expands Treatment Options for Patients with Atrial Fibrillation with Trailblazing Ablation System

DOYLESTOWN, Pa. (January 17, 2025) - Atrial fibrillation (AFib) is a progressive disease that occurs when the heart's upper chambers beat out of rhythm. As a result, blood is not pumped efficiently to the rest of the body. AFib is the most common atrial arrhythmia, affecting nearly 60 million people worldwide, ⁽¹⁾ and is associated with serious complications including heart failure, stroke and increased risk of death. ^(2,3,4,5) Doylestown Health is broadening its treatment options for AFib patients with a revolutionary system that recently received approval from the U.S. Food & Drug Administration (FDA).

The Affera™ Mapping and Ablation System with Sphere-9™ Catheter is an all-in-one high-density (HD) mapping and dual energy ablation (pulsed field (PF) and radiofrequency (RF)) catheter for the treatment of persistent AFib and ablation of cavotricuspid isthmus dependent atrial flutter using RF energy. In clinical trials, patients treated with the Sphere-9 catheter experienced improvements in quality of life for both mental and physical well-being. ⁽⁶⁾

"The Sphere-9 catheter allows physicians to map, ablate, and validate all with a single catheter, enhancing the safety of ablation procedures for our patients," said Robert M. Sangrigoli, MD, Director of the Electrophysiology Lab at Doylestown Hospital. "Doylestown Health's heart and vascular team has always been committed to identifying ways to improve and accelerate our ability to treat patients, and this technology will bring better care to patients suffering from AFib."

The first procedure at Doylestown Hospital was performed by Dr. Sangrigoli, who started the Electrophysiology Program at Doylestown Hospital in 2001. Doylestown Hospital is among just 16 in the nation and the first in the state of Pennsylvania to utilize this cutting-edge technology. Doylestown Health electrophysiologists Dr. Sangrigoli and John D. Harding, MD, participated in the clinical trials leading to the first PFA delivery systems to receive U.S. Food and Drug Administration approval, including the Affera Mapping and Ablation System.

The Affera Mapping and Ablation System enables physicians to customize treatment based on a patient's needs during an ablation procedure, using different energy sources and mapping capabilities to correct fast, abnormal heart rhythms. With the increasing number of patients with AFib and the recent U.S. FDA approval, the Affera system has the potential to provide a life-changing solution for people with AFib.

By adding the Affera Mapping and Ablation System to the hospital's existing pulsed field ablation technology, Doylestown Health's Heart & Vascular Services can now offer patients with rhythm disorders options to address their unique circumstances.

1 Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.

2 Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.

3 Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.

4 Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.

5 Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126.

6 Anter E, Mansour M, Nair DG, et al. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nature Medicine. 2024; 30: 2303-2310.