Registry Shows 100% Procedural Success With TAVI in Low-Risk Patients

August 30, 2011—The European Society of Cardiology (ESC) announced that results from a study presented at the ESC Congress 2011 in Paris, France show that transcatheter aortic valve implantation (TAVI) with the Edwards Sapien valve (Edwards Lifesciences, Irvine, CA) in low-risk patients achieved 100% procedural success.

This is a retrospective study from all 177 patients who were implanted with the Edwards prosthesis at the University Hospital in Rouen, France between May 2006 and January 2011. Prof. Alain G. Cribier, MD, performed the first-in-man percutaneous valve implantation at the Rouen center in 2002. Patients were divided into two groups according to their predictive logistic EuroSCORE: low EuroSCORE (< 20%) versus high EuroSCORE (> 20%). Based on the recommendations of both the ESC and the European Society of Cardiac Surgery, most TAVI registries have so far only included patients with a high logistic EuroSCORE of > 20%, the investigators noted.

Results show that procedural success was 100% in the low EuroSCORE group versus 95.3% in the high EuroSCORE group (P = .1). The investigators reported the absence of death at 1 month in the low EuroSCORE group versus a mortality rate of 11.1% in the high EuroSCORE group (P < .04). This result was confirmed at 1 year with mortality rates of 5% in the low-risk group versus 24.8% in the high-risk group (P < .01).

The investigators stated that they were expecting a lower mortality rate among patients with a low EuroSCORE, but the observed difference was much greater than anticipated, and the mortality rates approached the results with conventional surgery. These results represent a first step toward a broader assessment of percutaneous techniques in populations at lower surgical risk, without forgetting that surgery is currently the gold standard, concluded the investigators.

Investigator Matthieu Godin, MD, commented, “We sought to evaluate the results obtained in our subgroup of patients with a low EuroSCORE. It does not mean that the patients were at very low risk for TAVI, since they had been considered as having surgical contraindication, which did not affect the EuroSCORE (radiotherapy, corticosteroids, thoracic deformation, or porcelain aorta). However, the patients were often less sick and younger, and it seemed interesting to assess the results in this population.”

Dr. Godin added, “In view of the overall good results in this high-risk population, a significant trend to include lower-risk patients in Europe has been observed. The last registries have seen their EuroSCORE decreasing to 15%, and some prospective trials are planned to include patients whatever their score.”