Does mild paravalvular regurgitation post transcatheter aortic valve implantation affect survival? A meta‐analysis

Ando, Tomo; Briasoulis, Αlexandros; Telila, Tesfaye; Afonso, Luís; Grines, Cindy L.; Takagi, Hisato

doi:10.1002/ccd.27336

Cited by 54 publications

(39 citation statements)

References 63 publications

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“…Experience with conventional valve replacement suggest that mild paravalvular regurgitation may be associated with hemolysis but has no detrimental effect on cardiac performance or mortality outcomes (19,21). However, more contemporary experience in the context of transcatheter valve implantation raises concerns that even mild paravalvular regurgitation may be detrimental to patient survival (22). We demonstrated that the mean gradient across SURD was 2.46 mmHg higher than the mean gradient across RDV.…”

Section: Discussionmentioning

confidence: 72%

Sutureless valve and rapid deployment valves: a systematic review and meta-analysis of comparative studies

Flynn

Williams

Chakos

et al. 2020

Ann Cardiothorac Surg

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Background: The treatment of aortic valve disease is the most common valvular surgery in industrialized nations, with 3-9% of the population over the age of eighty having at least moderate aortic stenosis. As transcatheter aortic valve replacement (TAVR) has become more established, newer surgical prostheses have been developed with a variety of anchoring systems that do not rely solely on sutures to hold the valve in an appropriate position. The Edwards Intuity valve is a bovine pericardial prosthesis that is modelled on the widely implanted Perimount MagnaEase aortic prosthesis. The Perceval valve is a bovine pericardial valve attached to a self-expanding nitinol stent, which uses the radial force exerted on the patient's aortic annulus and aortic root by the stent portion to hold the valve in position. This meta-analysis compares the outcomes of comparative studies of these two valve systems. Methods: This systematic review and meta-analysis compares the outcomes of rapid deployment valves (RDV) and sutureless valves (SURD) and was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations and guidance. The search strategy interrogated six electronic databases. Outcomes measured included all-cause mortality at latest follow up, stroke, cross-clamp and cardiopulmonary bypass (CPB) times, pacemaker implantation rates, paravalvular leak and post-operative transvalvular gradient. Results: The search strategy identified 407 unique papers for initial assessment with seven studies qualifying for inclusion in the analysis. The outcomes of 4,076 patients (1,650 RDV, 2,426 SURD) were included. There was no difference in mortality, stroke or moderate or worse paravalvular regurgitation between the two groups. SURD had significantly shorter CPB time by 15.7 minutes [95% confidence interval (CI): 4.2-27.1; P=0.007] and a shorter cross-clamp time by 11.3 minutes (95% CI: 6.3-16.3; P<0.001) compared to RDV. RDV had a lower post-operative transvalvular gradient by 2.5 mmHg (95% CI: 1.2-3.8; P<0.001) and a lower rate of mild paravalvular regurgitation (OR 2.51; 95% CI: 1.435-4.768; P=0.004). Conclusions: Both valve types have an adequate safety profile and are comparable to conventional sutured prostheses. There was a significant reduction in cross-clamp and CPB times associated with SURD. This may be of benefit for patients requiring multiple concomitant procedures and increases the utility of minimally invasive valve replacement. However, SURD was associated with higher post-operative transvalvular gradients and a higher incidence of paravalvular regurgitation.

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Section: Discussionmentioning

confidence: 72%

Sutureless valve and rapid deployment valves: a systematic review and meta-analysis of comparative studies

Flynn

Williams

Chakos

et al. 2020

Ann Cardiothorac Surg

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“…Despite impact of mild PVR on outcomes is discrepant among different studies, Ando et al demonstrated that even mild PVR is associated with increased mid‐term all‐cause and cardiovascular mortality after TAVI in a recent meta‐analysis . This finding highlights the need of an optimal performance of the implanted device to ensure an optimal long‐term outcome of the procedure itself .…”

Section: Discussionmentioning

confidence: 99%

Outcomes of three different new generation transcatheter aortic valve prostheses

Costa

Buccheri

Barbanti

et al. 2019

Cathet Cardio Intervent

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Aims To evaluate outcomes of transfemoral transcatheter aortic valve implantation (TF‐TAVI) using three different new‐generation devices. Background Although new generation transcatheter aortic valves (TAVs) have demonstrated to improve procedural outcomes, to date few head‐to‐head comparisons are available among these devices. Methods This is a single center, retrospective study. From September 2014 to February 2018, 389 patients underwent elective TF‐TAVI for native, severe aortic stenosis using a new‐generation transcatheter aortic valve (TAV) with a preprocedural multi‐detector computed tomography assessment. Among these, 346 patients received an Edwards SAPIEN 3 (n = 134), Medtronic Evolut R (n = 111), or Boston ACURATE neo (n = 101) prosthesis. Differences in baseline clinical characteristics between groups were accounted using the propensity score weighting method. RESULTS The mean age for the entire study cohort was 81.4 ± 5.2 years while the Society of Thoracic Surgery predicted risk of mortality was 4.0 ± 2.5%. After propensity score weighting adjustment, TAVs did not differently impact on 30‐day all‐cause and cardiovascular mortality. Evolut R device showed an increased risk of permanent pacemaker implantation (PPI) after the procedure (8.3% for SAPIEN 3 vs. 16.7% for Evolut R vs. 2.1% for ACURATE neo, p < .05). At 30 days, patients treated with SAPIEN 3 valve showed a higher mean transvalvular gradient (9.7 ± 7.5 mmHg vs. 6.1 ± 2.4 mmHg vs. 8.4 ± 3.5 mmHg for SAPIEN 3, Evolut R, and ACURATE neo, respectively, p < .01) and a lower rate of more‐than‐trace paravalvular regurgitation (PVR) (18.8 vs. 47.9 vs. 45.8%, for SAPIEN 3, Evolut R, and ACURATE neo, respectively, p < .01). At 1 year, SAPIEN 3, Evolut R, and ACURATE neo TAVs showed excellent and comparable outcomes with no difference in terms of freedom from major adverse cardiovascular and cerebrovascular event (MACCE) (plog‐rank = 0.534). Conclusions TAVI using new‐generation prostheses was associated with high device success (97.0% vs. 92.8% vs. 95.0% for SAPIEN 3, Evolut R and ACURATE neo, respectively) and low complications rates up to 1 year. Evolut R valve was associated with a higher rate of PPI whereas SAPIEN 3 valve was associated with a higher mean transvalvular gradient and lower rate of more‐than‐trace PVR. At 1‐year, MACCE rates were similar among the three groups.

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“…Moderate or severe PVL is associated with intermediate and long-term morbidity and mortality 8,9 . Conflicting evidence exists regarding the impact of mild versus none to trivial PVL on mortality and morbidity 10,11 . Several factors might be of influence on these conflicting results.…”

Section: Glossary Of Abbreviationsmentioning

confidence: 99%

Aortic Regurgitation Index Ratio Is a Strong Predictor of 1-Year Mortality After Transcatheter Aortic Valve Implantation Using Self-Expanding Devices

Wely

Wulp

Rooijakkers

et al. 2021

Seminars in Thoracic and Cardiovascular Surgery

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Does mild paravalvular regurgitation post transcatheter aortic valve implantation affect survival? A meta‐analysis

Abstract: Mild PVR was associated with increased all-cause and cardiovascular mortality after TAVI. Whether further interventions in mild PVR is of benefit, has yet to be determined.

Cited by 54 publications

References 63 publications

Sutureless valve and rapid deployment valves: a systematic review and meta-analysis of comparative studies

Sutureless valve and rapid deployment valves: a systematic review and meta-analysis of comparative studies

Outcomes of three different new generation transcatheter aortic valve prostheses

Aortic Regurgitation Index Ratio Is a Strong Predictor of 1-Year Mortality After Transcatheter Aortic Valve Implantation Using Self-Expanding Devices

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