Orlando, Fla.--The FRANCE registry, the first registry evaluating both Edwards Lifesciences’ Sapien and Medtronic’s CoreValve bioprosthesis transcatheter aortic valves, showed comparable results between the two valves and the different approaches used, especially in high-risk patients. The data were presented at a late-breaking interventional clinical science session on Saturday at the American Heart Association (AHA) scientific sessions.
Principal investigator Helene Eltchaninoff, MD, University of Rouen in France, said that there was a need for a national, multicenter, prospective, real-life registry of transcatheter aortic valve implantation (TAVI), according to the current clinical indications. Also, she noted that France does not yet reimburse for valve replacement, and these data may serve as an appeal for reimbursement.
The 2002 first-in-man study showed that TAVI appeared as a possible alternative to conventional aortic valve replacement in high-risk surgical patients. Currently, more than 10,000 patients have been treated worldwide with this technique.
The FRANCE (FRench Aortic National CoreValve and Edwards) Registry enrolled 244 consecutive patients (average age 82, 44 percent females) in 16 centers throughout France, from Feb. 1 to Sept. 31.
The enrolled patients had to meet all three of the following inclusion criteria:
- Severe aortic stenosis: E.O.A. of less than 0.6 cm2/m2;
- Sever symptoms: dyspnea NYHA of at least 2;
- Patient at high surgical risk (determined by Euroscore/STS score).
Eltchaninoff said that the primary endpoint was 30-day mortality and the secondary endpoints (up to three years) were mortality, major adverse coronary events, hemodynamics and quality of life.
She explained that the implantation approach and the size of the valve varied across the procedures: The balloon-expandable Sapien (23 and 26 mm) was implanted either through femoral (39 percent) or apical (29 percent) approach; and the CoreValve (26 and 29 mm) was implanted either through femoral (27 percent) or sub-clavian (5 percent) approach.
Also, for the Sapien 42 percent of operators used the 23 mm and 58 percent use the 26 mm. For the CoreValve, 48 percent used the 26 mm and 52 percent used the 29 mm.
Two-thirds (66 percent) of all procedures took place in the cath lab, followed by 21 percent in the operating room and 12 percent in a hybrid room. Also, Eltchaninoff noted that transesophageal echocardiography was used in 75 percent of the procedures.
Device implantation success rate was 97 percent, which the researchers defined as successful delivery and deployment of the valve. There were four procedural deaths.
The 30-day mortality rate—the registry’s primary endpoint—was 12.7 percent with 31 deaths. After analyzing for 30 risk factors, the researchers found that prior bypass surgery and a Euroscore of 25 percent or greater were the only predictors of 30-day mortality by multivariate analysis.
Interestingly, 29 patients with recently-implanted pacemakers died—the single largest co-morbidity leading to death in the trial. The CoreValve femoral group experienced 18 of those deaths.
The researchers also found that vascular complications were nearly the same (five) in every group, except the CoreValve sub-clavian arm, which only had one incident.
Eltchaninoff said that their “registry demonstrates a high-success rate with excellent and sustained hemodynamic and clinical improvement,” adding that the mortality rate and complications are “acceptable in this high-risk population.”
She added that a six-month follow up is ongoing (111 patients have reached six months), but “survival appears similar to previous reported series.”
The panelists, who commented on the FRANCE registry, weighed in the benefits and obstacles of data that emerges from randomized controlled trials, compared data collected through real-life registries.
However, Peter C. Block, MD, from Emory University Hospital in Atlanta, who was a panel discussant, noted that while the 97 percent success rate is truly impressive, the importance of this registry is the insight into how facilities are performing these procedures, instead of which valve or method is superior.