Olaf Wendler gave a presentation at EuroPCR 2011 of the final one-year outcomes from more than 2,300 patients enrolled in the SOURCE registry. The registry provided “real world” post-commercialisation data from Europe, where the Sapien valve (Edwards Lifesciences) was first approved in 2007. These results have also been published recently in Circulation and the European Journal of Cardiothoracic Surgery.
The SOURCE registry began in 2007 to monitor procedural results with the commercialised Edwards Sapien valve. The registry has two Cohorts: Cohort 1, consisting of consecutive patients enrolled at 32 centres across Europe from November 2007 to January 2009; and Cohort 2, consisting of consecutive patients at 37 European centres followed from February 2009 to December 2009.
All centres were required to provide complete data sets on consecutive patients; the strict criteria for inclusion in the registry. At EuroPCR 2011, the complete one-year data from 2,307 patients in both cohorts were presented. The primary aim was to generate scientifically robust and comprehensive data on patient results as well as to identify predictors of outcome.
Early publication of 30-day data showed survival of 92.5% in patients who underwent TAVI via a transfemoral approach and 89.1% in those who underwent TAVI via the transapical approach.
Advances in patient selection
Patients selected for either the transfemoral or transapical approach approach continue to be at high-risk for conventional aortic valve repair. While the European learning curve has had some influence on the range of patients’ logistic EuroSCOREs, the overall EuroSCOREs remain high.
Compared with the transfemoral route, patients undergoing TAVI via the transpical approach still have a higher incidence of comorbidities, particularly extra-cardiac, such as pulmonary, peripheral vascular and carotid artery disease. This explains their 74.2% survival at one-year compared with 80.1% for the transfemoral approach. One-year mortality was significantly higher in patients with vascular access complications. Not unexpectedly, causes of death were mainly non-cardiac related. Interestingly, there was no significant improvement in terms of one-year mortality between Cohorts 1 and 2. It will therefore be interesting to see what impact the new generation Edwards Sapien XT valves and delivery devices will have on patient outcomes.
TAVI and CABG
An interesting sub-analysis of the SOURCE registry data focused on patients who subsequently underwent TAVI after they previously received coronary bypass surgery (CABG). Early reports on TAVI from North America in the highly selected group of patients in the PARTNER-US trial demonstrated inferior outcomes of TAVI in patients with previous CABG or percutaneous coronary intervention compared to surgical aortic valve repair. In the SOURCE registry, however, previous CABG was shown not to be a risk factor for TAVI one-year mortality.
Interestingly, there was no significant difference in mortality between the transfemoral and transapical approach, although the incidence of comorbidities in the transapical group was again higher. One contributing factor to these outstanding results may be the elimination of apical complications in the transapical group, which again demonstrates that reliable closure techniques for the left ventricular apex after transapical-TAVI are key for its success.
Olaf Wendler is clinical director for Cardiovascular Services and a consultant cardiothoracic surgeon, King’s College Hospital, London, UK.