Patent Foramen Ovale Closure With the SeptRx Device. Initial Experience With the First "In-Tunnel" Device.
Wibke J. Zimmermann, MD, Corinna Heinisch, MD, Nicolas Majunke, MD, Stephan Staubach, MD, Scott Russell, Nina Wunderlich, MD, Horst Sievert, MD*
CardioVascular Center, Sankt Katharinen, Frankfurt, Germany
Objectives: The purpose of this study was to evaluate the safety and effectiveness of the SeptRx patent foramen ovale (PFO) closure device (SeptRx, Inc., Fremont, California).
Background: A PFO is a relatively common remnant of the fetal circulation that can be associated with cryptogenic stroke, transient ischemic attack, migraine, or decompression sickness. Percutaneous PFO closure with different devices has been performed for many years. However, most of the common devices leave a relatively large amount of material in the left and right atria. The SeptRx PFO device (SeptRx, Inc.) is the first PFO closure device designed to fit directly into the pocket of the PFO.
Methods: From July 2006 to May 2007, 13 patients between 18 and 65 years of age with a history of cryptogenic stroke or transient ischemic attack were included into this first-in-man trial. All patients received 100 mg aspirin and 75 mg clopidogrel for 6 months. Follow-up was done at 1 and 6 months after procedure with transesophageal echocardiography and transcranial Doppler.
Results: In 11 of 13 patients, PFO closure with the SeptRx device was successfully performed. In 2 patients, PFO closure with this device was not possible due to the anatomy of the PFO; 1 device was retrieved before release, and the other was recaptured with a snare. After 30 days, 6 of the 11 PFOs were closed; after 6 months, all were closed. No adverse events occurred.
Conclusions: The SeptRx PFO closure device appears to be safe and effective. The advantage of this occluder is that there is only minimal foreign material on the left and right sides of the interatrial septum. This is the first such "in-tunnel" PFO closure device.
The longer anchors are on the left atrial side and are designed to uncoil to accommodate a range of patent foramen ovale (PFO) tunnel lengths. The interior of the device contains a fine-wire braided Nitinol mesh, which provides an immediate barrier to the conduction of emboli and is intended to stimulate the body‘s natural adhesion response for permanent closure of the PFO.
J Am Coll Cardiol Intv, 2010; 3:968-973
Patent Foramen Ovale Closure Using a Bioabsorbable Closure Device
Safety and Efficacy at 6-Month Follow-Up
Ben J. Van den Branden, MD*, Martijn C. Post, MD, PhD, Herbert W. Plokker, MD, PhD, Jurriën M. ten Berg, MD, PhD, Maarten J. Suttorp, MD, PhD
Department of Interventional Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands
Objectives: The aim of this study was to assess the mid-term safety and efficacy of percutaneous patent foramen ovale (PFO) closure using a bioabsorbable device (BioSTAR, NMT Medical, Boston, Massachusetts).
Background: Closure of PFO in patients with cryptogenic stroke has proven to be safe and effective using different types of permanent devices.
Methods: All consecutive patients who underwent percutaneous PFO closure with the bioabsorbable closure device between November 2007 and January 2009 were included. Residual shunt was assessed using contrast transthoracic echocardiography.
Results: Sixty-two patients (55% women, mean age 47.7 ± 11.8 years) underwent PFO closure. The in-hospital complications were a surgical device retrieval in 2 patients (3.2%), device reposition in 1 (1.6%), and a minimal groin hematoma in 6 patients (9.7%). The short-term complications at 1-month follow-up (n = 60) were a transient ischemic attack in the presence of a residual shunt in 1 patient and new supraventricular tachycardia in 7 patients (11.3%). At 6-month follow-up (n = 60), 1 patient without residual shunt developed a transient ischemic attack and 1 developed atrial fibrillation. A mild or moderate residual shunt was noted in 51.7%, 33.9%, and 23.7% after 1-day, 1-month, and 6-month follow-up, respectively. A large shunt was present in 8.3%, 3.4%, and 0% after 1-day, 1-month, and 6-month follow-up.
Conclusions: Closure of PFO using the bioabsorbable device is associated with a low complication rate and a low recurrence rate of embolic events. However, a relatively high percentage of mild or moderate residual shunting is still present at 6-month follow-up.
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