Control/Tracking Number: 05-SS-A-20713-AHA

Activity: Abstract
Current Date/Time: 5/27/2005 3:13:15 PM

Amplatzer® Patent Foramen Ovale Closure Device Safety and Efficacy: 90-day Event Rates in 490 High Risk Stratified Patients

Sherman G Sorensen, Utah Heart Clinic, LDS Hospital Cardiology, Salt Lake City, UT; Peter J Casterella, Utah Heart Clinic, Salt Lake City, UT; Joseph B Muhlestein, LDS Hospital Cardiology, University of Utah, Salt Lake City, UT; Laurie Raleigh, Heather Aguilar, K Wes Knight, Utah Heart Clinic, Salt Lake City, UT; Brianna S Ronnow, Heidi Thomas, Robert R Pearson, LDS Hospital Cardiology, Salt Lake City, UT; Donald L Lappé, LDS Hospital Cardiology, Utah Heart Clinic, Salt Lake City, UT

BACKGROUND: Percutaneous closure of a Patent Foramen Ovale (PC-PFO) for cerebrovascular accident (CVA) prevention is widely accepted despite the inability to complete randomized clinical trials. Observational studies have shown four clinical features (multiple MRI lesions [MMRI], interatrial septal aneurysm [IASA], migrane headaches [MHA] and severe power mode trans-cranial Doppler shunt [pm-TCD]) to be associated with high CVA risk and may justify PC-PFO. This study evaluated the 90-day safety and efficacy of the first 490 patients (pts) enrolled in a standardized management program.

METHODS: PFO pts with a history of CVA and at least one additional high risk feature as identified be neurology consultation, brain MRI, pm-TCD, contrast transthoracic echocardiogram (CTTE), and coagulation studies were evaluated. Pre-PC-PFO treatment included aspirin (325 mg/day) and preloaded clopodigrel (300 mg). Post-procedural treatment included 3 months of daily aspirin (325 mg) and clopidogrel (75 mg). Pts were risk stratified by the number of high-risk features and followed-up at 90 days with clinical evaluation, CTTE, and pm-TCD.

RESULTS: All pts (average age 49 +/- 14 years, females = 64%) had PC-PFO using the Amplatzer® device. Clinical follow-up and CTTE/pm-TCD were available in 458 (93%) and 412 (84%), respectively. The distribution of high-risk features was: MMRI = 406 (91%), IASA = 211 (43%), MHA = 176 (36%), TCD-5 = 446 (91%), and > = high-risk features = 371 (76%). At follow-up, pm-TCD shunt at rest and with Valsalva decreased from 2.74 +/- 1.86 to 0.54 +/- 1.02 (p<0.0001) and 4.73 +/- 0.7 to 1.86 +/- 1.72 (p<0.0001), respectively. MHA decreased from 176 to 23 (p<0.0001). Procedural complications were rare, including access site bleeding (n=4), transfusion (n=3), and surgery (n=0). Adverse events at 90 days included TIA (n=7[1.4%], 4 stopped anti-platelet therapy), pericardial effusion without tamponade (n=3[0.6%]), and CVA (n=0).
CONCLUSION: In this high risk PFO population treated with catheter closure, the use of a rigorous standardized management protocol resulted in low procedural and 90-day adverse event rates indicative of the absence of significant device-related adverse complications, and high procedural success.

Category (Complete): Adult Congenital Heart Disease (CVDY)