Experience and improved patient selection have improved outcomes with transapical aortic valve implantation in the PARTNER trial Non-Randomized Continued Access (NRCA) programme, new results have shown. Improvement was seen in the rates of death, stroke and bleeding in the NRCA patients compared to those enrolled in the randomised PARTNER trial Cohort A, Todd M Dewey told delegates at The Society of Thoracic Surgeons (STS) Annual Meeting in Fort Lauderdale, USA.
Transapical aortic valve implantation was an integral part of the PARTNER trial. However, only 104 procedures were performed as part of the PARTNER trial transapical cohort, thus reflecting the preliminary experience of many of the participating centres, Todd M Dewey, Medical City Dallas Hospital, Dallas, USA, said.
PARTNER A stratified high-risk surgical patients by their suitability for a transfemoral TAVI. Patients deemed unsuitable for the transfemoral approach were randomised to either a Sapien valve (Edwards Lifesciences) via transapical delivery or standard surgical valve replacement.
“Upon completion of the PARTNER trial, participating centres were able to continue to enrol patients into a NRCA programme. We compared the outcomes of the transapical aortic valve implantation procedures performed as part of the NRCA programme to those seen in the PARTNER trial transapical cohort,” he added.
Eight hundred and twenty three patients underwent transapical aortic valve implantation as part of the post-PARTNER trial NRCA programme between September 2009 and September 2011. The average STS predicted risk of mortality was 12.4±4.8, and the average Logistic EuroSCORE was 29.1±16.8.
The average predicted risk of operative mortality at 30 days, according to the STS Adult Cardiac Database, was 12.2%. During continued access, mortality at 30 days was 8.2% and, at one year, it was 23.6%. The randomised portion of the PARTNER trial had previously demonstrated that, for the patients treated with transapical TAVI, mortality at 30 days and one year was 8.7% and 29.1%, respectively. The STS score of average predicted risk of operative mortality at 30 days in this group of patients was 12.1%.
After the procedure, early symptom improvement was observed as measured by NYHA class. At baseline, 5% of continued access patients were assessed as NYHA class I or II, and at 30 days, this number increased to 77%. At one year, the benefits of aortic valve replacement were evident in all groups, as measured by improvements in NYHA class.
“Improvement was seen in the major outcome variables in the NRCA transpical patients compared to the PARTNER trial. These improvements can be attributed to a number of factors including: improved patient selection, individual centres surmounting the procedural learning curve, and refinements in surgical technique,” Dewey said. “These results mirror those seen in the PARTNER trial transfemoral cohort.”
In November 2011, the Edwards Sapien valve received FDA approval for the treatment of inoperable patients; it is currently an investigational device for the treatment of high-risk patients.