Meta-analysis reported in the journal Cardiology, shows that across 6 randomized clinical trials, closure of patent foramen ovale (PFO) is superior to medical treatment alone for prevention of secondary stroke in individuals who had cryptogenic stroke and PFO (relative risk [RR] = .041, 95% CI: 0.20-.83). Stratification and subgroup analysis of results by size of PFO revealed that this was driven primarily by benefits of closing medium or large PFOs (RR = 0.35, 95% CI:0.18-0.68) with no significant difference between closure of small PFO and medical treatment (RR = .18, 95% CI: 0.56-1.78). Individuals who had PFO closure had increased risk of atrial fibrillation compared to those who had medical treatment (RR 5.29; 95% CI: 2.18-42.63).
A review article in the same issue covered the importance of risk stratification and patient selection for PFO closure and recommended assessment by a team including, at a minimum, a neurologist and cardiologist. Proposed patient selection include those under age 65 who have had a cryptogenic stroke, a moderate-to-large PFO with high likelihood of embolism, and unfavorable risk to benefit ratio with medical treatment alone.
Robert J. Cubeddu, MD, section head, Structural Heart Disease, Heart & Vascular Institute, Cleveland Clinic Florida, who recently presented tips for an institution-wide, centralized, and multidisciplinary PFO program at the Society for Cardiovascular Angiography & Interventions (SCAI) 2019 meeting said, “We recommend use of a structured PFO program and multidisciplinary team including neurologists, cardiologists, interventional cardiologists, radiologists, and pulmonologists. Such a team can together evaluate both clinical considerations (eg, age, nature and quality of primary stroke, and other comorbid conditions) and anatomic considerations (eg, size and location of PFO, length of tunnel between atria, demonstration of left-to-right shunt, and any other septal defects) to guide patient selection.”
Dr. Cubeddu suggested a dedicated program and team will benefit from shared experience and volume, which, in turn, may increase rigor of patient selection and operator efficiency with either device approved for PFO closure. There are 2 devices approved by the Food and Drug Administration for PFO closure, the Amplatzer PFO occlude (Abbott, Abbot Park, IL) and the GORE Cardioform Septal Occluder (W. L. Gore & Associates; Flagstaff, AZ).
Allie Massaro, MD
James Geyer, MD, and Paul Cox
Claire Smyth, BSc; David Roberts, BSc; and Kenneth Monaghan, PhD