Category (Complete): Congenital Heart Disease
Presentation Format (Complete): Oral

Control/Tracking Number: 05-A-1248-CRF

Activity: Abstracts
Current Date/Time: 6/9/2005 3:22:08 PM

Use of the Amplatzer® SO Device for Percutaneous Patent Foramen Ovale Closure: Tunnel Reduction Technique and Initial Outcomes

Sherman G Sorensen¹, Peter J Casterella¹, Brian K Whisenant¹, Laurie Raleigh², Heather Aguilar², K Wes McKnight², Donald L Lappé¹, Joseph B Muhlestein^3
1Utah Heart Clinic and LDS Hospital Cardiology, Salt Lake City, UT;²Utah Heart Clinic, Salt Lake City, UT;³LDS Hospital Cardiology, Salt Lake City, UT

BACKGROUND: Patent foramen ovale (PFO) closure is commonly performed using devices with a thin, central, connecting pin design. Specific PFO anatomic features may result in sub-optimal defect closure using such devices. The Amplatzer® SO device, PMA approved for atrial septal defect closure, has less design features which may result in better PFO closure due to tunnel occlusion, less free device overlap, and greater tissue contact. The current study evaluates the initial outcomes of PFO closure using the Amplatzer® SO device.

METHODS: A review of 50 consecutive patients undergoing PFO closure at our institution was made. All patients presented with recurrent neurologic events and had a PFO with > = 2 additional risk factors for recurrent stroke. PFO tunnel reduction was performed using a contrast inflated pulmonary capilary wedge catheter balloon pulled back against the septum to stretch and collapse the tunnel to the level of the septum secundum. A 24 mm sizing balloon was then used to size the defect, define resolution of the tunnel length and further reduce the tunnel, and to define displacement of left atrial entry orifice. Amplatzer SO devices were placed by standard method.

RESULTS: Procedural success without complications was 100%. Device sizes ranged from 6-20mm. Following PFO closure, 2 patients had residual trace shunting by intra-cardiac echo assessment with agitated saline injection. Following balloon pull-back technique, 15 (30%) of the patients had a residual tunnel length of > 9mm. Following sizing balloon inflation beyond stop-flow pressure, 14 of these 15 patients showed further decrease in tunnel length to < = 5mm. Device implantation in these patients with long tunnel lengths did not result in dislodgement, device instability, or mal-apposition.

CONCLUSION: This feasibility study of the use of the Amplatzer® SO device for PFO closure demonstrated a high (100%) procedural success rate without major complications. Further evaluation of the Amplatzer® SO device will assist in defining its role in PFO closure. These initial results suggest that this device may be a reasonable alternative to current PFO devices in selected anatomic variations.
Author Disclosure Block: S.G. Sorensen, None.

Category (Complete): Congenital Heart Disease
Presentation Format (Complete): Oral
Keywords (Complete): Shunt closure: ASD, PFO, etc ; Congenital Heart Disease
Status: Complete