Periprocedural and postprocedural outcomes of patients with tricuspid aortic valve undergoing transcatheter aortic valve implantation with the myval valve

Abstract Background Transcatheter aortic valve implantation(TAVI) has emerged as a standard treatment for patients with severe symptomatic aortic stenosis.While the Myval transcatheter heart valve(THV) has shown promising results,its safety and efficacy in patients with tricuspid aortic valve(TAoV) anatomy require further investigation. Purpose This study aimed to assess the safety and efficacy of the Myval THV in patients with TAoV. Methods We performed a screening in the three major databases, to identify relevant studies published up to December 19th 2024.The primary endpoint was device success.Secondary endpoints included periprocedural,in-hospital and 1-year all-cause mortality,in-hospital,30-day and 1-year stroke, in-hospital and 30-day major vascular complications and at least moderate transvalvular aortic regurgitation(AR) rates,in-hospital permanent pacemaker implantation(PPI),annular rupture,acute kidney injury(AKI),more than mild paravalvular AR,need for 1 THV,device embolization,coronary artery occlusion or obstruction and cardiac tamponade and 30-day early safety,minor vascular complications,life-threatening and major bleeding rates. Results We included 7 studies comprising 727 patients with TAoV undergoing TAVI with the Myval THV. Device success was reported in 97.1%(95%CI:93.5%–100%) of cases,indicating a high procedural success rate.In-hospital all-cause mortality and periprocedural mortality were 1.6%(95%CI:0%–3.5%) and 0.6%(95%CI:0%–2.7%),respectively.Stroke rates remained low,with in-hospital and 30-day rates of 0.85%(95%CI:0%–2.5%) and 1.1%(95%CI:0%–2.7%),respectively.The in-hospital PPI rate was 12%(95% CI: 0%–31%).Annular rupture was not reported 0%(95%CI:0%–1%),while in-hospital AKI occurred in 4.2%(95%CI:0%–9.8%) of patients.Vascular complications were infrequent, with in-hospital and 30-day major vascular complications occurring in 2.6% (95%CI:0.34%–4.8%) and 10.4% (95%CI:0%–2.6%) of cases,respectively,while minor vascular complications at 30 days were 5.7%(95%CI:2.8%–8.6%).The incidence of greater-than-mild paravalvular leakage and moderate-to-severe transvalvular aortic regurgitation was low, both reported at 1.5%(95%CI:0%–7.5%) in-hospital, increasing to 2.7% (95% CI: 0%–8.1%) at 30 days. Other procedural complications, including the need for 1 THV 0.1%(95%CI:0%–1.2%),device embolization 0.36%(95%CI:0%–2.4%),coronary artery occlusion or obstruction0.14%(95%CI:0%–1.2%) and cardiac tamponade 0.33%(95%CI:0%–1.6%) were rare.At 1-year,all-cause mortality was 9.6%(95%CI:4.1%–15.2%),while stroke rates remained low at 3.9%(95%CI:0%–10.3%).The 30-day early safety rate was 55.4%(95%CI:11.8%–99%),while 30-day major bleeding rates were 1.6%(95%CI:0%–5.3%). Conclusion The Myval THV demonstrated high device success and favorable safety outcomes in patients with TAoV undergoing TAVI.Further prospective studies with long-term follow-up are warranted to confirm these findings.