Abstract 1935: Single Center Results of PFO Closure without an Implantable Device
Background: Percutaneous closure of patent foramen ovale (PFO) to prevent recurrent paradoxical embolism is frequently performed, however, currently available closure devices are implantable, leaving a foreign structure in the atria. The PFxTM Closure System (Cierra, Inc., Redwood City, CA) is a novel method for closure of PFO without leaving foreign material in the body. Procedural and mid-term outcomes using the PFx-15 on PFO less than 10mm are reported.
Methods: The PFx Closure System is a percutaneous system that employs radiofrequency (RF) energy to effect closure of a PFO by welding the tissues of the septum primum and septum secundum together. The PFx catheter is positioned over the PFO on the right atrial surface using fluoroscopy and TEE guidance. Once in place, vacuum is applied to hold the septum primum and septum secundum in place. The two layers of tissue are then fused with RF energy applied via an electrode. From April 2005 through March 2006, 36 patients (age 18 – 65 years, mean 48.9 + 11.6) with PFO less than 10mm (mean 7.3 + 1.9mm, range 3 – 9.9mm) in diameter and history of stroke or TIA due to paradoxical emboli were treated using the PFx-15 catheter.
Results: In 35 of 36 patients, the catheter was successfully placed and energy applied. Procedure time was 34.0 + 12.6 minutes (range of 18 – 70) and the average time of RF application was 6.7 minutes (range of 3 – 10). The average follow up is 5 months (range of one to 12 months) with 20 patients achieving successful PFO closure in their first procedure. There were no peri- or post-interventional complications nor pain associated with application of RF energy. No arrhythmias were observed. Events noted during follow-up, but unrelated to the device, included one each of the following: infection, AV fistula, fever, and possible seizure (pre-existing condition). Three patients who were not successfully closed on the initial procedure were brought back for evaluation and re-treated increasing the overall number of closures to 23 (64%) for this initial study group.
Conclusions: This initial experience demonstrates that PFO closure using radiofrequency energy in lieu of an implantable device is technically feasible. On-going device and procedural modifications are also contributing to improved clinical outcomes.