ABSTRACT 1
Reduced Adverse Event Rates After Transcatheter Closure of Patent Foramen Ovale When Using the Amplatzer-PFOTM Compared to the CardioSealTM Device
Journal of American Collage of Cardiology 2004;43:377A
Sherman G. Sorensen, Peter J. Casterella, Joseph B. Muhlestein, Robert R. Pearson, Benjamin D. Horne, Laurie Raleigh, Tami L. Bair, Jeffrey L. Anderson, Donald L. Lappe', LDS Hospital, Salt Lake City, UT
Background: Transcatheter closure of patent foramen ovale (PFO-C) is a low risk, outpatient procedure for stroke prevention. Although very low death or non-fatal stroke (CVA) rates occur after PFO-C, a variety of other neurologic sequelal (ONS) and device-related complications (DRC) (ie thrombus, late device deformation requiring removal, or endocarditis) do occur and may increase post-procedural testing and cost. The two available PFO-C devices, Amplatzer-PFOTM (AMP) and CardioSealTM (CS) devices differ significantly in design, materials and deformability, but whether these differences effect post-procedural outcome after PFO-C is unknown.
Methods: A total of 370 consecutive patients undergoing PFO-C at a single institution between January, 2001 and May, 2003 were followed for occurrence of death, CVA, ONS (requiring evaluation by either brain imaging or trans-esophageal echo), or DRC. Of these, 261 (71%) (age = 50±15 yrs, males = 42%, follow-up (F/U) = 17±7 months) received CS and 109 (29%) (age = 49±15 yrs, males = 33%, F/U = 6±2 months) received AMP. Patients recieving CS or AMP were compared by cox hazard analysis adjusted for baseline variables and length of follow-up.
Results: Incidence of death (1, 0.3%) and CVA (2, 0.5%) was low and did not differ between groups. Incidence of DRC was 8 (2.2%), only occurred in the CS device and generally occurred late (median = 11 months) during follow-up. Incidence of ONS was significantly greater [78 (30%) versus 7 (6.4%), p<0.001] in patients receiving CS than AMP. The Cox hazard of ONS was significantly greater for CS versus AMP [univariate hazard ratio (HR) = 0.26 (CI=0.11-0.63, p=0.002), adjusted HR = 0.25 (CI=0.11-0.59, p=0.001)] as well as for any adverse event [univariate HR = 0.30 (CI=0.14-0.67, p=0.003), adjusted HR = 0.25 (CI=0.14-0.67, p=0.003)].
Conclusion: In this large single-center consecutive study of patients undergoing PFO-C, adverse event rates were significantly reduced by the use of the Amplatzer-PFOTM compared with the CardioSealTM device. The underlying reasons for these results require further study.
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