Long-term durability and haemodynamic performance of a self-expanding transcatheter heart valve beyond five years after implantation: a prospective observational study applying the standardised definitions of structural deterioration and valve failure

Holy, Erik W.; Kebernik, Julia; Abdelghani, Mohammad; Stämpfli, Simon F.; Hellermann, Jens; Allali, Abdelhakim; El-Mawardy, Mohamed; Sachse, Susanne; Lüscher, Thomas F.; Tanner, Felix C.; Richardt, Gert; Abdel‐Wahab, Mohamed

doi:10.4244/eij-d-18-00041

Cited by 74 publications

(40 citation statements)

References 21 publications

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“…The published evidence showed that the all-cause mortality was very high in TAVI patients. 1,31,32) Holy, et al 31) reported that the all-cause mortality rate at 1, 5, and 8 years was 14%, 50%, and 73% in patients who were treated with selfexpanding CoreValve devices. Similarly, the all-cause mortality at 5 years was 60.8% in FRANCE-2 trial 1) and 67.8% in PARTNER-1 trial.…”

Section: Discussionmentioning

confidence: 99%

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

Wang

et al. 2020

Int. Heart J.

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Section: Discussionmentioning

confidence: 99%

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

Wang

et al. 2020

Int. Heart J.

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“…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].…”

Section: Expert Opinionmentioning

confidence: 99%

Transcatheter aortic valve replacement: clinical safety and performance data

Baal

Roszek

Elk

et al. 2019

Expert Review of Medical Devices

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Introduction: Patients with severe aortic stenosis and regurgitation who are inoperable or at high-risk for surgery can be treated with transcatheter aortic valve replacement (TAVR). The aim of this study was to provide a comprehensive overview of the literature of TAVR and reported clinical and performance outcomes. Areas covered: A total of 16 devices, described in 204 articles describing clinical and performance outcomes, were included. The most frequently observed outcome was 30-day mortality, ranging between 0-23%. Other commonly reported clinical outcomes were 30-day stroke, ranging between 0-14.3% and pacemaker implantation, ranging from 0-44.9%. The most common valve performance outcome was aortic valve regurgitation, however, mostly reported at 7 days follow-up. Next to a followup period of 30 days, numerous articles reported outcomes at 6 months and 1 year. The numbers of articles describing outcomes with a longer follow-up as well as including intermediate and low-risk patients were limited. Expert commentary: This literature review provided a clear overview of the reported clinical and performance outcomes of TAVR devices. Despite the frequently used VARC-2 definitions, we identified a huge variation across studies. Future studies using standardized definitions of study setups and outcomes are essential and might lead to better insights of TAVR.

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“…The incidence of SVD at discharge and 1 year were significantly higher in our study than others. 2,19,20) We hypothesized the reasons may be concluded as followed: First, every THV has its unique design of strut and frame, such as J-Valve was designed as a short cylindrically self-expandable stent with three U-shaped graspers encircling the prosthetic valve, which is benefit for the surgical procedure in patients with PAR. The shape of THV stent and its expanding patterns (self-expanding or balloon-expanding) may determine the incidence of short-term postoperative SVD, and affect the long-term durability of the THV thereby.…”

Section: Discussionmentioning

confidence: 99%

Structural Valve Deterioration after Transcatheter Aortic Valve Implantation Using J-Valve: A Long-Term Follow-Up

Wang

et al. 2020

ATCS

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Purpose: Our study aimed to investigate the structural valve deterioration (SVD) after transcatheter aortic valve implantation (TAVI) using J-Valve. Methods: In all, 14 patients with aortic stenosis (AS) and 4 patients with pure aortic regurgitation (PAR) were available in the study. Four-year follow-up was performed in all patients, and the clinical data and echocardiographic findings were recorded and analyzed. Results: All patients survived at the 4-year follow-up. There was no evidence of morphological SVD or prosthetic valve thrombosis in enrolled patients. None of the hemodynamic SVD occurred in patients with PAR. Mean gradients decreased from 61.93 ± 15.42 mm Hg (pre-TAVI) to 19.64 ± 9.16 mm Hg (discharge) in patients with AS (p <0.001); subsequently, a slight increase was observed in the mean trans-aortic gradient throughout follow-up (p = 0.967). Overall, in patients with AS, six individuals suffered moderate (3/14, 21.4%) or severe (3/14, 21.4%) hemodynamic SVD at 4-year follow-up. Conclusions: The limited number of cases provides a preliminary indication of the longterm efficacy of TAVI using J-Valve in patients with PAR. In patients with AS, although the higher rate of SVD was observed, the overall transcatheter heart valve (THV) hemodynamics remained stable over time after prosthetic valve implantation and the longterm durability of J-Valve was convincing.

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Long-term durability and haemodynamic performance of a self-expanding transcatheter heart valve beyond five years after implantation: a prospective observational study applying the standardised definitions of structural deterioration and valve failure

Abstract: Long-term follow-up up to 8.9 years after TAVI documents favourable performance of the self-expanding CoreValve with low rates of BVF.

Cited by 74 publications

References 21 publications

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

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

Transcatheter aortic valve replacement: clinical safety and performance data

Structural Valve Deterioration after Transcatheter Aortic Valve Implantation Using J-Valve: A Long-Term Follow-Up

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