PARIS, France—An up-to-date analysis from the largest prospective and comprehensive registry of transcatheter aortic valve implantation (TAVI) involving both Edwards and CoreValve bioprostheses shows a high success rate with good sustained hemodynamic and clinical improvement in French patients.

Findings from the FRANCE (FRench Aortic National Corevalve and Edwards) 2 Registry were presented August 29, 2011, at the European Society of Cardiology Congress by Martine Gilard, MD, PhD, of the University of Brest (Brest, France).

The registry includes all TAVI cases from 33 French centers and now stands at 3,075 patients, Dr. Gilard reported, while the current interim analysis covers 2,419 patients enrolled between January 1, 2010, and July 11, 2011. During this period, 68% of patients received Edwards Sapien devices (Edwards Lifesciences, Irvine, CA) and 32% received CoreValve devices (Medtronic, Minneapolis, MN). Most valves were implanted transfemorally, although 19% of procedures were performed by the transapical route and 5% by the subclavian route.

Mean patient age was 82.5 ± 7 years, and subjects were evenly divided between men and women. In addition, 68% had hypertension, 48% dyslipidemia, 25% diabetes, 22% peripheral arterial disease, and 48% CAD. Overall, patients were at high surgical risk: The average logistic EuroScore was 22.3% and similar between the 2 groups, and the Society of Thoracic Surgeons score was 14.7. Moreover, 75% of patients were New York Heart Association (NYHA) class 3 or 4.

Most procedures were performed under general anesthesia (71.6%) and in the cath lab, although an increasing proportion are done in hybrid suites (15.7%), Dr. Gilard said. Valves were successfully delivered and deployed in 97.1% of cases.

Improvements in Gradient, LVEF

Patients had severe stenosis, with an average gradient of 48.3 ± 16.6 mm Hg and LVEF of 53.2 ± 14%. After implantation, the mean gradient decreased to about 10 mm Hg and remained at that level out to 1 year. Periprosthetic valve regurgitation was grade 0 to 1 in 85.4% of patients, rising to 90.4% at 1 year. Importantly, mean LVEF increased during follow-up to 57.5% at 6 months and 56.3% at 1 year.

Mortality stood at 9.9% by 30 days and at 17.2% by 6 months, with almost identical rates for the 2 valve types.

Mortality was also analyzed according to the type of valve implanted and the access route. When valves were implanted by the transfemoral route, the Edwards valve performed somewhat better than the CoreValve device (table 1).

Table 1. Mortality by Valve Type and Access

Major complications were assessed at 30 days using Valve Academic Research Consortium criteria. The only clear difference between the 2 devices was more frequent implantation of a new pacemaker with CoreValve (table 2).

Table 2. Major Complications at 30 Days

After multivariate analysis, logistic EuroScore and NYHA functional class were the only predictors of 30-day and 6-month mortality.

A separate economic analysis showed that the mean implantation cost varies with the procedure site (the cath lab costs less than a hybrid suite or operating room), the type of valve (CoreValve is less than Edwards, although this difference disappears when hospital stay is taken into account), and the approach (arterial is less than transapical). Importantly, the overall hospital costs for aortic valve replacement in high-risk patients are higher for surgery than for TAVI.

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