Routine transcatheter aortic valve implantation (TAVI) using both Medtronic’s CoreValve and Edwards Lifesciences’ Sapien valve with a selection of approaches is feasible and allows treatment of a range of patients with good overall procedural success rates and 30-day and six-month outcomes, according to a study in the November issue of the Journal of the American College of Cardiology: Cardiovascular Interventions.
Cosmo Godino, MD, from the interventional cardiology unit at San Raffaele Institute in Milan, Italy, and colleagues sought to assess clinical outcome after TAVI performed with the two commercially available valves with three delivery approaches selected in a stepwise fashion. They noted that “limited data exist” on the results of a comprehensive TAVI program using different valves with transfemoral, transapical and transaxillary approaches for treatment of severe aortic stenosis.
In the study, a total of 137 patients underwent TAVI: 107 via transfemoral (46 CoreValve and 61 Sapien), 15 via transaxillary (12 CoreValve and three Sapien) and 15 via transapical approach.
After the transfemoral approach, the procedural success rate was 93.5 percent and major vascular complication rate was 20.6 percent, according to the researchers. No intra-procedural deaths occurred. The procedural success rates of transapical and transaxillary approaches were 86.6 percent and 93.3 percent, respectively.
Godino and colleagues also report that the 30-day mortality rate was 0.9 percent in transfemoral group and 13.3 percent in transapical and no deaths occurred after transaxillary access. Cumulative death rate at six months was 12.2 percent in transfemoral, 26.6 percent in transapical and 18.2 percent in transaxillary groups.
At multivariable analysis, logistic European System for Cardiac Operative Risk Evaluation, body surface area and history of cerebrovascular disease were significantly associated with an increased risk of major adverse cardiac and cerebrovascular events.
In the study, the authors reported that patients selected for the transfemoral approach with both valves were no different in terms of baseline clinical characteristics except for differences in the aortic annulus diameter, which was predictably smaller in the patients who received Sapien. The CoreValve implantation was characterized by a significantly lower rate of procedural success, a higher rate of valve embolization and need for a second valve. Moreover, the frequency of permanent pacemaker implantation is greater after a CoreValve procedure compared with Sapien (26.1 vs. 11.5 percent).
Based on their findings, the authors concluded: “The overall procedural success rate of 92.7 percent is encouraging, suggesting that—with careful screening and appropriate technique—immediate procedural success can be achieved in most patients in whom the procedure is attempted. In this series no death occurred during the procedure.”
However, they noted that while “preliminary results are encouraging, only randomized controlled trials and larger registries with longer follow-up will help to delineate the safety and durability of this strategy. At present, rigorous patient selection, individualized decision-making and full cooperation of the multidisciplinary team are paramount to ensure that each individual receives the best possible treatment modality with the maximal safety and efficacy.”