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One-Year Outcomes of Cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry: The European Registry of Transcatheter Aortic Valve Implantation Using the Edwards SAPIEN Valve
Study Questions:
What are the one-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry?
Methods:
The SOURCE Registry was designed to assess initial post-commercial clinical transcatheter aortic valve implantation (TAVI) results of the Edwards SAPIEN valve in consecutive patients in Europe. Cohort 1 consists of 1,038 patients enrolled at 32 centers. Survival analysis was performed by Kaplan-Meier, with patients being censored as of the last date known alive.
Results:
Patients with the transapical approach (n = 575) suffered more comorbidities than transfemoral patients (n = 463), with a significantly higher logistic EuroSCORE (29% vs. 25.8%; p = 0.007). These groups are different; therefore, outcomes cannot be directly compared. Total Kaplan-Meier 1-year survival was 76.1% overall, 72.1% for transapical and 81.1% for transfemoral patients, and 73.5% of surviving patients were in New York Heart Association (NYHA) class I or II at 1 year. 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.
Conclusions:
The authors concluded that with new transcatheter aortic techniques, excellent 1-year survival in high-risk and inoperable patients is achievable.
Perspective:
The survival for Cohort 1 undergoing TAVI from the SOURCE Registry shows that an improvement compared with historical controls and survival for the transfemoral approach is now >80%. There has also been an important improvement in the transapical patients, with survival now similar to historical transfemoral controls. The SOURCE Registry data set may facilitate the development of a TAVI risk score, which could lead to improved patient selection for the procedure. This risk score and avoidance of vascular complications by lower-profile devices may result in further improvements in 1-year survival. Furthermore, the 1-year results of Cohort 1 of the SOURCE Registry provide a benchmark against which future TAVI cohorts and new TAVI devices may be measured. Since adverse events were self-reported by the participating centers in this registry, more robust independently adjudicated clinical studies are indicated to assess this new technology.
Keywords: Registries, Hyperlipidemias, Bioprosthesis, Survival Analysis, Europe, New York, Carotid Stenosis, Hypertension
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