Background: Transcatheter aortic valve implantation (TAVI) is the new standard of care for inoperable patients with severe aortic stenosis and an alternative to surgical replacement in high operative risk patients. The currently most widely
used valves are Edwards SAPIEN and CoreValve.
Methods: We analyzed data of 424 consecutive patients undergoing trans-femoral TAVI at the Tel Aviv Medical Center, and performed a comparison between the two bioprostheses regarding pre-procedural patient’s characteristics, procedural data and 1 year post-procedural clinical outcome.
Results: CoreValve and the Edwards SAPIEN prostheses were implanted in 320 and 104 patients, respectively. CoreValve patients were older (83±5 vs. 81±7 years, p=0.026), with lower estimated glomerular filtration rate (60±18 vs. 66±20 ml/min/1.73m2, p=0.011), higher EuroSCORE (25± 14 vs. 20± 13 %, p=0.015) and a smaller pre-procedural aortic valve area (0.69± 0.18 vs. 0.74± 0.19 cm2, p=0.035). No other differences regarding patient's characteristics were observed. Compared to TAVI with Edwards prosthesis, Corevalve procedures had shorter fluoroscopy time (16.4±6 vs. 17.5±5 minutes, p=0.02), higher patient's cumulative radiation dose (1477±755 vs. 1197±591 Gy, p<0.001), and less contrast media (143±40 vs. 157±40 ml, p=0.001). Device success was similar among the two valves (95 vs. 96 %, p=0.57).
Mortality (in hospital and after 1 year) was similar among the valves implanted (2.5 vs. 2.9%, p=0.83, and 15.7 vs. 19%, p=0.54). CoreValve patients had higher rates of permanent pacemaker implantation (24.4 vs. 11.5%, p=0.005), and post-procedural blood transfusion (40 vs. 25%, p=0.014). No difference was observed regarding vascular complication (18 vs. 21%, p=0.49), stroke (1.3 vs. 1.9%, p=0.61), moderate or severe paravalvular leak (2 vs. 2.6%, p=0.766), or acute kidney injury of any stage (13.8 vs. 19.6%, p=0.15).
Conclusions: Despite differences in patient's and procedural characteristics between CoreValve and Edwards Sapiens TAVI, device success and mortality rates were similar.
