Single center experience with transcatheter aortic valve implantation using the Edwards SAPIEN™ Valve.

OBJECTIVES: The use of transcatheter aortic valve implantation (TAVI) for high-risk patients was introduced in the early 2000s for treatment of aortic valve stenosis patients with too high surgical risk. During the last years, there has been a dramatic increase in TAVI procedures. TAVI programs are implemented in numerous cardiac centers. This paper describes a single center experience with its first 100 TAVI procedures.

METHODS: This study included the first 100 patients who were scheduled for either transfemoral (F-TAVI) or transapical (A-TAVI) aortic valve implantation at Aarhus University Hospital, Skejby, using the Edwards SAPIEN™ valve. The indication for TAVI was unacceptable high predicted risk associated with conventional surgery. Patients with adequate diameter of iliac arteries were scheduled for F-TAVI, otherwise A-TAVI was preferred.

RESULTS: The patients were treated between February 2006 and June 2010. Of these were 44% males and 56% females with a mean (S.D.) age of 81 (7.0). Thirty-days mortality rate was 8%, and decreased from 12% among the first 50 patients to 4% for the last 50 patients. Successful implantation was achieved in 92% patients. Major non-fatal complications were seen in 5% of 76 A-TAVI and in 0% of 24 F-TAVI patients. Mean (S.D.) EuroSCORE in the F-TAVI and A-TAVI groups was 15.9 (9.4) and 21.5 (14), respectively (p = 0.06). Post-procedural leakage of cardiac biomarkers was significantly higher in the A-TAVI group as compared to in the F-TAVI group. Mean (S.D.) NYHA class improved from 2.9 (0.6) to 1.8 (0.7) p < 0.001, with no significant difference between A-TAVI and F-TAVI patients.

CONCLUSION: In surgically non-amenable patients, TAVI can be performed with acceptable mortality and morbidity and results in marked functional improvement. A decrease in 30-day mortality over time indicated a learning curve when implementing this treatment.