Author/Authors :
Popma، نويسنده , , Jeffrey J. and Adams، نويسنده , , David H. and Reardon، نويسنده , , Michael J. and Yakubov، نويسنده , , Steven J. and Kleiman، نويسنده , , Neal S. and Heimansohn، نويسنده , , David and Hermiller Jr.، نويسنده , , James and Hughes، نويسنده , , G. Chad and Harrison، نويسنده , , J. Kevin and Coselli، نويسنده , , Joseph and Diez، نويسنده , , Jose and Kafi، نويسنده , , Ali and Schreiber، نويسنده , , Theodore and Gleason، نويسنده , , Thomas G. and Conte، نويسنده , , John and Buchbinder، نويسنده , , Maurice and Deeb، نويسنده , , G. Michael and Carabello، نويسنده , , Blasé and Serruys، نويسنده , , Patrick W. and Chenoweth، نويسنده , , Sharla and Oh، نويسنده , , Jae K.، نويسنده ,
Abstract :
Objectives
tudy sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery.
ound
ted severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy.
s
formed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG).
s
l of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis).
sions
ith a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)
