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J Am Coll Cardiol. 2018 May 22;71(20):2335-2342. doi: 10.1016/j.jacc.2018.02.046. Epub 2018 Mar 12.

Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial.

Author information

1
Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
2
Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. Electronic address: jksong@amc.seoul.kr.
3
Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
4
Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
5
Department of Cardiology, School of Medicine, Chungnam National University, Chungnam National University Hospital, Daejeon, South Korea.
6
Department of Neurology, School of Medicine, Chungnam National University, Chungnam National University Hospital, Daejeon, South Korea.

Abstract

BACKGROUND:

Recent reports showing the favorable role of patent foramen ovale (PFO) closure in patients with cryptogenic stroke have raised the issue of selecting optimal candidates.

OBJECTIVES:

This study, DEFENSE-PFO (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale), evaluated whether the benefits of PFO closure can be determined on the basis of the morphologic characteristics of the PFO, as evaluated by transesophageal echocardiography.

METHODS:

Patients with cryptogenic stroke and high-risk PFO were divided between a transcatheter PFO closure and a medication-only group. High-risk PFO included PFO with atrial septal aneurysm, hypermobility (phasic septal excursion into either atrium ≥10 mm), or PFO size (maximum separation of the septum primum from the secundum) ≥2 mm. The primary endpoint was a composite of stroke, vascular death, or Thrombolysis In Myocardial Infarction-defined major bleeding during 2 years of follow-up.

RESULTS:

From September 2011 until October 2017, 120 patients (mean age: 51.8 years) underwent randomization. PFO size, frequency of septal aneurysm (13.3% vs. 8.3%; p = 0.56), and hypermobility (45.0% vs. 46.7%; p > 0.99) were similar between the groups. All PFO closures were successful. The primary endpoint occurred exclusively in the medication-only group (6 of 60 patients; 2-year event rate: 12.9% [log-rank p = 0.013]; 2-year rate of ischemic stroke: 10.5% [p = 0.023]). The events in the medication-only group included ischemic stroke (n = 5), cerebral hemorrhage (n = 1), Thrombolysis In Myocardial Infarction-defined major bleeding (n = 2), and transient ischemic attack (n = 1). Nonfatal procedural complications included development of atrial fibrillation (n = 2), pericardial effusion (n = 1), and pseudoaneurysm (n = 1).

CONCLUSIONS:

PFO closure in patients with high-risk PFO characteristics resulted in a lower rate of the primary endpoint as well as stroke recurrence. (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale [DEFENSE-PFO]; NCT01550588).

KEYWORDS:

cryptogenic stroke; echocardiography; patent foramen ovale

PMID:
29544871
DOI:
10.1016/j.jacc.2018.02.046

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