Long-term results and durability of the CoreValve transcatheter aortic bioprosthesis: outcomes beyond five years

Abstract

Aims: to determine long-term outcomes of high-risk patients who underwent transcatheter aortic valve implantation (TAVI) with third-generation CoreValve device, according to the 2017 EAPCI/ESC/EACTS definition of valve durability.Methods and results: between 2007 and 2013, 278 consecutive patients were enrolled in our prospective single-centre CoreValve registry (mean age 82±6 years, mean STS score 6.4±5.0%); median follow-up of survivors was 6.8 years. The Cox proportional hazards model was used to identify independent predictors of HF-rehospitalization and all-cause mortality. Predictors of HFrehospitalization were LVEF, MR and PVL at last echocardiographic follow-up. The majority of patients were in NYHA class I or II and showed mild/trivial paravalvular leak throughout follow-up.Mean pressure gradients remained stable over time. The overall crude cumulative incidences of structural valve deterioration and bioprosthetic valve failure were 3.6% and 2.5% respectively.Conclusions: although overall mortality was high in this elderly patient cohort, the CoreValve bioprosthesis showed excellent durability at 7-year follow-up.

Transcatheter aortic valve replacement: clinical safety and performance data

“…The Notion trial has a follow-up of up to 6 years assessing valve durability comparing TAVR and SAVR [32]. These studies demonstrated no alarm concerning transcatheter durability [33], 3.3% of patients had undergone valve implantation again due to paravalvular leakage [34] and a majority of patients showed mild/ trivial paravalvular leakage during long-term follow-up [35]. Results on valve performance with a follow-up of 5 years are promising, however, the number of studies is limited and assessment in younger and lower-risk patients is required [33].…”

Comparison of Procedural and 1-Year Clinical Results of Transcatheter Aortic Valve Implantation Using Prostheses with Different Design of Support Frame

“…ranscatheter aortic valve implantation (TAVI) has emerged as an alternative treatment for patients with aortic stenosis (AS) who are at intermediate to high risk for surgery, 1,2) and the procedure exhibited a convincing long-term efficacy. With the emergence of new TAVI systems, transcatheter heart valve (THV) devices with different support frame designs were used in interventional treatment for aortic disease.…”

Long-term Transcatheter Aortic Valve Durability

“…After the introduction of EAPCI/ESC/EACTS standardised criteria of SVD in 2017, an increasing number of studies have been reporting outcomes after TAVI with either the SAPIEN (Edwards Lifesciences) or CoreValve TAVs up to 7 and 8 years ( Table 4 ). [38–41] Three single-centre studies demonstrated stable trans-prosthetic gradients over time and a rate of severe TAV dysfunction of 2.4%, 3.2% and 3.6%. [39–41] Holy et al analysed long-term outcomes of 152 consecutive patients who had undergone TAVI with the self-expanding CoreValve between 2007 and 2011.…”

“…[38–41] Three single-centre studies demonstrated stable trans-prosthetic gradients over time and a rate of severe TAV dysfunction of 2.4%, 3.2% and 3.6%. [39–41] Holy et al analysed long-term outcomes of 152 consecutive patients who had undergone TAVI with the self-expanding CoreValve between 2007 and 2011. [42] Echocardiographic follow-up was achieved at 6.3 ± 1.0 years (5.0–8.9 years) and was 88% complete (60 of the 68 participants who survived beyond 5 years).…”