One-Year TAVI Outcomes Published for Edwards' SOURCE Registry

July 11, 2011—Martyn Thomas, MD, et al published 1-year outcomes of Cohort 1 in the European SOURCE Registry online ahead of print in Circulation. SOURCE is studying the Edwards Sapien aortic bioprosthesis (Edwards Lifesciences, Irvine, CA) for transcatheter aortic valve implantation (TAVI). In related news, a US Food and Drug Administration (FDA) advisory panel will review the company's premarket approval application for the Sapien transcatheter heart valve on July 20.

According to the investigators, the SOURCE Registry is the largest consecutively enrolled registry for TAVI procedures. It was designed to assess initial postmarket clinical TAVI results of the Sapien valve in consecutive patients in Europe. Cohort 1 is composed of 1,038 patients enrolled at 32 centers.

The investigators concluded that the data demonstrate that, with new transcatheter aortic techniques, excellent 1-year survival in high-risk and inoperable patients is achievable and provide a benchmark against which future TAVI cohorts and devices can be measured.

As detailed in Circulation, at 1 year, patients who underwent TAVI with the transapical approach (n = 575) experienced more comorbidities than transfemoral patients (n = 463), with a significantly higher logistic EuroSCORE (29% vs 25.8%; P = .007). The investigators advised that these groups are different; therefore, outcomes cannot be directly compared.

The investigators reported that total Kaplan Meier 1-year survival rates were 76.1% overall, 72.1% for transapical, and 81.1% for transfemoral patients. Also at 1 year, 73.5% of surviving patients were in New York Heart Association (NYHA) class I or II. Combined transapical and transfemoral causes of death were cardiac in 25.1%, noncardiac in 49.2%, and unknown in 25.7%. Pulmonary complications (23.9%), renal failure (12.5%), cancer (11.4%), and stroke (10.2%) were the most frequent noncardiac causes of death.

Multivariable analysis identified logistic EuroSCORE, renal disease, liver disease, and smoking as variables with the highest hazard ratios for 1-year mortality, whereas carotid artery stenosis, hyperlipidemia, and hypertension were associated with lower mortality, stated the investigators in Circulation.

On May 20, Cardiac Interventions Today reported that the Cohort I data along with Cohort II data were presented at the EuroPCR meeting in Paris.

Information about the FDA's Circulatory System Devices Panel of the Medical Devices Advisory Committee is available on the FDA Web site. Edwards Lifesciences announced the meeting on June 7, as reported in Cardiac Interventions Today. In the United States, the Edwards Sapien valve is an investigational device and is not yet commercially available.