CHICAGO — Patients with severe aortic stenosis who underwent transcatheter aortic valve replacement with the CoreValve device had low rates of mortality and stroke and significant improvements in valve function at 1- and 6-month follow-up.
Survival rates were high at both 30 days (95.5%) and 6 months (87.2%) after implantation. Overall complication rates were low, with stroke rates of 2.9% at 30 days and less than 3.5% at 6 months. The primary endpoint of major adverse cardiac and cerebrovascular events (composite of all-cause mortality, MI, emergent cardiac surgery or percutaneous reintervention and stroke) was reported in 8.3% of patients at 30 days.
Additionally, the procedural success rate was 97.8%. Patients in the study experienced significant improvements in valve function; mean gradient decreased from 45.6 mm Hg at baseline to 9.3 mm Hg at 30 days.
The data were presented at the American College of Cardiology’s 61st Scientific Sessions.
From March 2010 to July 2011, 1,015 high-risk patients with severe aortic stenosis were enrolled at 44 centers — each of which had performed a minimum of 40 procedures before joining the trial — in 12 countries in Asia, South America and Western Europe. The mean age of the patients was 81 years and 51% were women.
“Our objective was to evaluate the efficacy, safety and clinical outcomes of TAVI using the Medtronic CoreValve System in a real-world patient population — patients with severe aortic stenosis had to be inoperable or high risk for conventional [aortic valve replacement], based on the decision of the center cardiac team,” Axel Linke, MD, professor of cardiology at the University of Leipzig Heart Center in Leipzig, Germany, said at a press conference.
The prospective, single-arm ADVANCE study follows several trials already conducted to determine the safety and effectiveness of TAVR. However, it is the first large TAVR trial to use the Valve Academic Research Consortium (VARC) standards to define adverse events.
“With regard to complications, we did not have a single valve rupture, as has been seen [in other trials] … and one conversion to conventional surgery,” Linke said. “Patients who were highly symptomatic before intervention experienced dramatically improved conditions following the procedure.
Life-threatening or disabling bleeding was observed in 4% of patients at 30 days. The researchers also found persistent improvements in aortic valve function, accompanied by better exercise capacity.
Linke added, “Ninety-eight percent of patients in the study were effectively treated with the valve, with no requirement for further intervention. These results contributed to the low mortality rate of 4.5% at 30 days, and less than 13% at the 6 months follow-up.”
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Disclosure: Dr. Linke has received research funding support and consulting fees from Medtronic.