Results reflecting the real-life experiences of transcatheter aortic valve replacement in France suggest that the treatment strategy may be a reasonable option for high-risk elderly patients with aortic stenosis.
The study, which was published in The New England Journal of Medicine, included 3,195 patients (mean age, 82.7 years; 49% women) from the FRANCE 2 registry who had severe aortic stenosis. The devices used in the study were the Sapien and Sapien XT (n=2,107; Edwards Lifesciences) and the CoreValve (n=1,043; Medtronic), and the primary endpoint was all-cause mortality.
Researchers used the transfemoral approach in 74.6% of patients, transapical in 17.8% of patients and subclavian in 5.8%, and had a procedural success rate of 96.9%. At 30 days, the primary endpoint was 9.7%, 18.6% at 6 months and 24% at 1 year for the entire cohort. Also at 1 year, the rate of stroke was 4.1% and the rate of periprosthetic aortic regurgitation was 64.5%.
Predictors of a significantly decreased likelihood of survival in multivariate analysis were periprosthetic regurgitation grade 2 or higher vs. less than grade 2 (HR=2.49; 95% CI, 1.91-3.25); NYHA Class III or IV vs. I or II symptoms (HR=1.49; 95% CI, 1.09-2.03); transapical approach vs. transfemoral approach (HR=1.45; 95% CI, 1.09-1.92); and a higher logistic risk score on the EuroSCORE (HR per 1% increase=1.37; 95% CI, 1.19-1.58).
For more information:
Gilard M. N Engl J Med. 2012;366:1705-1715.
This study highlights a new therapeutic option for a lot of patients who would not be treated otherwise. Particularly promising, if you look at the HF classification going into this study, more than 70% of patients had Class III or IV HF, and at 1 year, it was essentially reversed, more than 70% were in Class I or II. Stroke and periprosthetic regurgitation are of concern, but the incidence is probably acceptable in this high-risk population. Possibly future devices will address these issues.
From my experience, both the Sapien and CoreValve devices work very well. I don’t know if we will ever have a randomized controlled trial comparing the two valves, but judging by the European data, they look fairly comparable. There are some anatomic considerations that favor one device over the other, but, in general, despite not having enough data to comment on the differences between the two devices, we can say that the procedure itself has a very high success rate and acceptable complication rates in these very sick patients.
– Robert Kipperman, MD
Associate Director, Advanced Interventional Therapeutics Program, Morristown Medical Center, Morristown, N.J.
Disclosure: Dr. Kipperman is one of the principal investigators for the CoreValve pivotal trial, but reports no relevant financial disclosures.