Ganesh Athappan (Department of Cardiovascular Medicine, Heart & Vascular Medicine Institute, Case Western Reserve University, Cleveland, USA) and others report that their meta-analysis, published ahead of print in the Journal of the American College of Cardiology, of transcatheter aortic valve implantation (TAVI) studies indicates that the rate of post-TAVI stroke is similar between different valve designs (eg. CoreValve vs. Sapien) and approaches (eg. transapical vs. transfemoral).
Kapadia et al write that the increased risk of 30-day stroke observed with the Sapien TAVI valve (Edwards Lifesciences) when compared to surgery or medical therapy in the PARTNER studies raised concerns about the safety of TAVI. They add that there has been speculation that the delivery route (transapical or transfemoral) or valve design (Sapien vs. Medtronic’s CoreValve) could influence the risk of stroke after TAVI but note that neither of these theories has been “conclusively shown”. The authors therefore performed a meta-analysis of the available TAVI data to compare the risk of stroke between the CoreValve and the Sapien valve and the risk of stroke between the transfemoral approach and the transapical approach.
The primary endpoint was the 30-day risk of stroke after transfemoral and transapical approaches and the 30-day risk of stroke after CoreValve and Sapien implantations.
Among the 29,065 patients from (25) multicentre studies, the pooled estimate for the overall incidence of the 30-day stroke rate was 2.8% in both the patients (18,712) who underwent the transfemoral approach and in those (5,650) who underwent the transapical approach. The incidence of 30-day stroke was also similar between the approaches in the single-centre studies (7,149 overall; 3.8% of 4,556 for transfemoral and 3.4% of 2,588 for transapical).
Furthermore, there were no significant differences in the incidence of 30-day stroke between patients who received the CoreValve and those who received the Sapien valve in either the multicentre studies or the single-centre studies—2.4% of 8,684 and 3.8% of 2,617 for CoreValve vs. 3% of 16,082 and 3.2% of 3,477 for the Sapien valve, respectively. Kapadia et al comment: “In our pooled analysis, the risk of stroke was similar between valve types. Despite the similar stroke risk, there might be important differences in the timing of stroke inherent to each valve, an understanding of which may be crucial in developing future valve designs to reduce stroke.”
The authors also found that the rate of stroke declined over time, which they say reflects “continually improving outcomes after TAVI” and conclude: “Reduction in device profiles over time and advancements in technique are likely to make TAVI safe, to potentially expand its indications to a low-risk profile.”
The results of the CHOICE trial, which compares the CoreValve with the Sapien valve, will be presented in a late-breaking trial session at the American College of Cardiology (ACC) annual meeting (29–31 March, Washington DC, USA).