Author + information
- Received February 11, 2018
- Revision received February 26, 2018
- Accepted February 27, 2018
- Published online March 12, 2018.
- Pil Hyung Lee, MDa,
- Jae-Kwan Song, MD, PhDa,∗ (, )
- Jong S. Kim, MD, PhDb,
- Ran Heo, MDa,
- Sahmin Lee, MDa,
- Dae-Hee Kim, MD, PhDa,
- Jong-Min Song, MD, PhDa,
- Duk-Hyun Kang, MD, PhDa,
- Sun U. Kwon, MD, PhDb,
- Dong-Wha Kang, MD, PhDb,
- Dongwhane Lee, MDb,
- Hyuk Sung Kwon, MDb,
- Sung-Cheol Yun, PhDc,
- Byung Joo Sun, MD, PhDd,
- Jae-Hyeong Park, MD, PhDd,
- Jae-Hwan Lee, MD, PhDd,
- Hye Seon Jeong, MD, PhDe,
- Hee-Jung Song, MD, PhDe,
- Jei Kim, MD, PhDe and
- Seung-Jung Park, MD, PhDa
- aDepartments of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
- bDepartments of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
- cDepartments of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
- dDepartments of Cardiology, School of Medicine, Chungnam National University, Chungnam National University Hospital, Daejeon, Korea
- eDepartments of Neurology, School of Medicine, Chungnam National University, Chungnam National University Hospital, Daejeon, Korea
- ↵∗Address for Correspondence
: Jae-Kwan Song, MD, PhD Division of Cardiology, Asan Medical Center University of Ulsan College of Medicine 88, Olympic-ro 43-gil Songpa-gu, Seoul 05505, Korea Telephone: +82-2-3010-3150 Fax: +82-2-475-6898.
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 We evaluated whether the benefits of PFO closure can be determined based on 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 (TIMI)-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 groups. All PFO closures were successful. The primary endpoint occurred exclusively in the medication-only group (6/60 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), TIMI-defined major bleeding (n=2), and transient ischemic attack (n=1). Non-fatal 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.
- Received February 11, 2018.
- Revision received February 26, 2018.
- Accepted February 27, 2018.