TAVI using the Myval THV demonstrated low all-cause mortality rates of 0.4% in-hospital, 2% at 30 days, and 8.6% at 1 year, alongside low rates of stroke and periprocedural complications.
Meta-Analysis (n=2,060)
What are the safety and efficacy outcomes of the Myval transcatheter heart valve in patients undergoing TAVI?
The Myval transcatheter heart valve demonstrates low rates of mortality, stroke, and periprocedural complications up to 1 year in patients undergoing TAVI.
Abstract Background Transcatheter Aortic Valve Implantation (TAVI) has been established as a first-line treatment for severe aortic valve stenosis. The Myval transcatheter heart valve (THV) is a novel balloon-expandable platform designed to reduce conduction disturbances and improve hemodynamic performance. Purpose Our systematic review and meta-analysis aimed to assess the safety and efficacy of the Myval THV in patients undergoing TAVI. Methods We screened the three major databases to identify relevant studies published up to December 19th, 2024. Primary outcomes included in-hospital, 30-day, and 1-year all-cause mortality rates. Secondary outcomes assessed in-hospital, 30-day, and 1-year stroke and permanent pacemaker implantation(PPI) rates, along with in-hospital and 30-day acute kidney injury(AKI), major and minor bleeding, and aortic regurgitation (paravalvular and transvalvular AR) and in-hospital annular rupture, convert to surgery, need for 1 THV, need for re-intervention, rehospitalization, device embolization and cardiac tamponade. Results We included 17 studies comprising 2,060 patients undergoing TAVI with the Myval THV. Ιn-hospital all-cause mortality rate was 0.4% (95%CI:0%–0.99%), increasing to 2% (95%CI:1.2%–2.9%) at 30 days and 8.6% (95%CI:6%–11.3%) at one year. Stroke rates remained low, with in-hospital, 30-day and 1-year rates of 0.9% (95%CI:0%–2%), 1.5% (95% CI:0.7%–2.4%) and 3.2% (95%CI:0.3%–6.1%), respectively. The 30-day PPI rate was 10.6% (95%CI:7%–14.2%), while AKI occurred in 1.7% (95%CI:0.55%–2.9%) of patients during hospitalization. Bleeding complications were infrequent, with in-hospital and 30-day major bleeding rates of 1.5% (95%CI:0%–2.9%) and 1.6% (95%CI:0%–3.2%), respectively, while in-hospital minor bleeding was reported in 13.6% (95%CI:4.7%–22.5%). The incidence of greater-than-mild paravalvular AR was 0.4% (95%CI:0%–1.5%) in-hospital and 1.1% (95%CI:0%–2.2%) at 30 days, while moderate to severe transvalvular AR was observed in 0.15% (95%CI:0%–1.3%) of cases in-hospital and 4.4% (95%CI:1.1%–7.7%) at 30 days. Conversion to surgery occured in 0.28% (95%CI:0%–1%) of patients, and the need for 1 THV in 0.27% (95%CI:0%–0.88%). Rehospitalization was required in 1.6% (95%CI:0%–3.5%). Device-related complications were infrequent, with in-hospital device embolization occurring in 0.3% (95%CI:0%–1.3%) of cases and cardiac tamponade in 0.18%(95%CI:0%–1.1%). Conclusion Our findings show that the Myval THV offers a safe and effective alternative for patients undergoing TAVI, with low mortality, stroke, PPI and periprocedural complications rates. Further large-scale prospective studies are warranted to confirm these findings.
Apostolos et al. (Sat,) conducted a meta-analysis in severe aortic valve stenosis (n=2,060). Myval transcatheter heart valve (THV) was evaluated on 1-year all-cause mortality (95% CI 6-11.3). TAVI using the Myval THV demonstrated low all-cause mortality rates of 0.4% in-hospital, 2% at 30 days, and 8.6% at 1 year, alongside low rates of stroke and periprocedural complications.