Original Studies Use of Balloon Pull-Through Technique to Assist in CardioSEAL Device Closure of Patent Foramen Ovale Kavitha Chintala, 1 MD, Daniel R. Turner, 1 MD, Stephanie Leaman, 1 Edwin Rodriguez-Cruz, 1 MD, Joshua Wynne, 2 MD, Adam Greenbaum, 3 MD, and Thomas J. Forbes, 1 * MD CardioSEAL device closure of patent foramen ovale (PFO) has been advocated for the treatment of patients with cryptogenic stroke. Using the standard delivery technique, partial deployment of the CardioSEAL device can occur, especially in patients with a thick septum secundum and/or long PFO tunnel. We hypothesized that using a left atrial-to- right atrial balloon pull-through to make the septum primum incompetent would result in improved final device position regardless of septal thickness or tunnel length. Catheter- ization reports, cineangiograms, and transesophageal echocardiograms of 51 patients who underwent CardioSEAL device closure of PFO between March 2000 and August 2002 were retrospectively reviewed. Group 1 (n  21) included patients with CardioSEAL placement using the standard technique and group 2 (n  30) included patients with CardioSEAL placement using the balloon pull-through technique. There were no differ- ences between the groups in terms of age (43.6 vs. 45.3 years; P  NS), weight (83.3 vs. 89.9 kg; P  NS), septum secundum thickness (6.4 vs. 7.0 mm; P  NS), PFO tunnel length (15.5 vs. 13.1 mm; P  NS), or device size. In group 1, 4/21 (19%) had partial deployment of the CardioSEAL device, while in group 2, no partial CardioSEAL deployment (0/30) was observed. No complications were associated with the balloon pull-through technique. We conclude that the left atrial-to-right atrial balloon pull-through technique is safe and may allow for better final position of the CardioSEAL device during PFO closure. Catheter Cardiovasc Interv 2003;60:101–106. © 2003 Wiley-Liss, Inc. Key words: heart defects; congenital; cerebrovascular accident; catheterization INTRODUCTION Patent foramen ovale (PFO) diagnosed by transesoph- ageal echocardiography (TEE) is present in approxi- mately 10% of a controlled population [1] and in 30% of patients with cerebrovascular accident or transient isch- emic attacks [2]. Until the last decade, surgical PFO closure or anticoagulation therapy was used in patients presumed to have paradoxical embolus as the etiology of their stroke [3,4]. Recently, transcatheter PFO closure using various devices has become increasingly popular, with a few small studies suggesting reduction in stroke recurrence during a short-term follow-up [5–7], with several other large-scale prospective randomized trials being in place. The CardioSEAL device (Nitinol Medical Technologies, Boston, MA) is a non-self-centering de- vice approved for use in the United States under a Hu- manitarian Device Exemption (HDE) protocol since Feb- ruary 2000. Certain anatomical characteristics of septum primum and septum secundum may preclude optimal CardioSEAL de- vice positioning during closure of PFO. Improper final device position may be related to a long PFO tunnel length and/or a thick septum secundum. When the degree of over- lap between septum primum and septum secundum is large, the long PFO tunnel that has to be traversed may potentially cause deformity of the left atrial umbrella before complete deployment of the right atrial side when using the standard 1 Division of Cardiology, Children’s Hospital of Michigan, Wayne State University, Detroit, Michigan 2 Division of Cardiology, Harper Hospital, Wayne State Univer- sity Detroit, Michigan 3 Division of Cardiology, Henry Ford Hospital, Detroit, Michigan *Correspondence to: Dr. Thomas J. Forbes, Director, Cardiac Cathe- terization Laboratory, Children’s Hospital of Michigan, 3901 Beaubien Boulevard, Detroit, MI 48201. E-mail: tforbes@dmc.org Received 10 October 2002; Revision accepted 22 April 2003 DOI 10.1002/ccd.10603 Published online in Wiley InterScience (www.interscience.wiley.com). Catheterization and Cardiovascular Interventions 60:101–106 (2003) © 2003 Wiley-Liss, Inc.