Meta-analysis of short- and long-term clinical outcomes of the self-expanding Evolut R/pro valve versus the balloon-expandable Sapien 3 valve for transcatheter aortic valve implantation

Lerman, Tsahi T.; Levi, Amos; Kornowski, Ran

doi:10.1016/j.ijcard.2022.09.035

Cited by 10 publications

(7 citation statements)

References 45 publications

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“…The hemodynamic advantage of TAVI was most prominently demonstrated in the self-expanding subgroup perhaps owing to their supra-annular functional design which facilitates larger effective valve diameter. This finding was consistent with a recently published meta-analysis from our group, comparing the latest-generation self-expanding valve with the balloon-expandable valve ( 44 ). Despite the favorable forward hemodynamic profile of TAVI, a significant inferiority was demonstrated with regard to the rate of moderate–severe AR and the rate of reintervention.…”

Section: Discussionsupporting

confidence: 93%

“…It has been previously established that balloon-expandable and self-expanding valves have a different efficacy and safety profile. This is reflected by differences in pacemaker implantation rate, periprocedural bleeding rate, and hemodynamic profile ( 44 ) Combined with the results of the current study examining the durability of TAVI valves, we believe that a set of considerations are obtained that should be incorporated into the heart team decision-making ( 44 ).…”

Section: Discussionmentioning

confidence: 86%

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Comparison of middle-term valve durability between transcatheter aortic valve implantation and surgical aortic valve replacement: an updated systematic review and meta-analysis of RCTs

Lerman,

Levi,

Jørgensen

et al. 2023

Front. Cardiovasc. Med.

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BackgroundThis study aims to compare valve durability between transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR).MethodsWe conducted a systematic review and meta-analysis using data from randomized controlled trials (RCTs). The primary outcome was structural valve deterioration (SVD). Secondary outcomes were bioprosthetic valve failure, reintervention, effective orifice area (EOA), mean pressure gradient, and moderate–severe aortic regurgitation (AR, transvalvular and/or paravalvular).ResultsTwenty-five publications from seven RCTs consisting of 7,970 patients were included in the analysis with follow-up ranges of 2–8 years. No significant difference was found between the two groups with regard to SVD [odds ratio (OR) 0.72; 95% CI: 0.25–2.12]. The TAVI group was reported to exhibit a statistically significant higher risk of reintervention (OR 2.03; 95% CI: 1.34–3.05) and a moderate–severe AR (OR 6.54; 95% CI: 3.92–10.91) compared with the SAVR group. A trend toward lower mean pressure gradient in the TAVI group [(mean difference (MD) −1.61; 95% CI: −3.5 to 0.28)] and significant higher EOA (MD 0.20; 95% CI: 0.08–0.31) was noted.ConclusionThe present data indicate that TAVI provides a comparable risk of SVD with favorable hemodynamic profile compared with SAVR. However, the higher risk of significant AR and reintervention was demonstrated.Systematic Review RegistrationPROSPERO (CRD42022363060).

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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 86%

Comparison of middle-term valve durability between transcatheter aortic valve implantation and surgical aortic valve replacement: an updated systematic review and meta-analysis of RCTs

Lerman,

Levi,

Jørgensen

et al. 2023

Front. Cardiovasc. Med.

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“…Multiple meta-analyses have evaluated the BEV and SEV for different outcomes in transcatheter aortic replacement. However, we found that most studies evaluated either short-term outcomes, procedural success, or aortic function restoration, while one study compared long-term and short-term outcomes 34 – 38 . Our paper is the first to consider combining and subgrouping outcomes at a particular time frame for analysis.…”

Section: Discussionmentioning

confidence: 98%

Comparing outcomes of balloon-expandable vs. self-expandable valves in transcatheter aortic valve replacement: a systematic review and meta-analysis

Khan,

Farrukh,

Belay

et al. 2024

Annals of Medicine &Amp; Surgery

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Background: Aortic stenosis (AS) is a common heart condition categorized into congenital and acquired forms. Transcatheter Aortic Valve Replacement (TAVR) is an innovative method for AS management, and two valve types, Self-Expanding Valves (SEV) and Balloon-Expandable Valves (BEV), are used in TAVR. The objective of this study is to compare the clinical outcomes associated with balloon-expandable and self-expandable valves in transcatheter aortic valve replacement. Methods: The researchers conducted a comprehensive meta-analysis following PRISMA guidelines and AMSTAR 2 tool. The methodology involved a systematic literature search, strict eligibility criteria, unbiased study selection, meticulous data extraction, quality assessment, and rigorous statistical analysis. Results: Our analysis included twenty-six papers and 26553 patients. BEV exhibited significant advantages over SEV in overall mortality across 21 studies, particularly in perioperative and 30-day assessments. However, no substantial disparities emerged between the two valve types in stroke incidence. BEV demonstrated notable benefits in reducing hospitalization rates across 6 studies and significantly fewer instances of permanent pacemaker implantations across 19 studies, particularly evident in the perioperative setting. Other secondary outcomes like bleeding, acute kidney injury, and myocardial infarction showcased non-significant differences between BEV and SEV. Conclusion: The analysis indicates that BEV may offer benefits in specific aspects of TAVR outcomes, but further research is needed to fully understand the factors influencing patient outcomes and mortality in TAVR procedures.

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“…Shoshan et al 27 showed greater transprosthetic among the Sapien 3 group in the short term, and He et al 28 reported superior hemodynamic performance of the Evolut R as compared with the Sapien 3, similar to their study, and the current study found that the Evolut R had significantly lower mean gradient compared with the Sapien 3 devices. Furthermore, a case-match cohort study by Enríquez-Rodríguez et al 29 revealed higher residual gradients in the Sapien 3 than the Evolut R. Finally, a meta-analysis by Li et al 30 also reported a higher mean gradient in the short term in Sapien 3 versus Evolut R. Another meta-analysis of short-term and long-term clinical outcomes of the Evolut R/pro valve versus the Sapien 3 valve for TAVI by Lerman et al 31 demonstrated lower transvalvular gradients in the Evolut R/pro compared with the Sapien 3 group. Nevertheless, the results of our study were consistent with the echocardiographic findings of previous studies in Sapien 3 and Evolut R.…”

Section: Discussionmentioning

confidence: 98%

Comparison of 1-year Follow-up Echocardiographic Outcomes of Sapien 3 Versus Evolut R Bioprosthetic Transcatheter Aortic Valves: A Single-center Retrospective Iranian Cohort Study

Sahebjam

Zoroufian

Hajizeynali

et al. 2023

Critical Pathways in Cardiology: A Journal of Evidence-Based Medicine

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Objective: The current study aimed to compare 1-year echocardiographic outcomes of the new generations of self-expanding (Evolut R) versus balloonexpandable (Sapien 3) bioprosthetic transcatheter aortic valves. Methods: In this study, gradients and flow velocities obtained from transthoracic Doppler-echocardiography were retrospectively collected from patients who underwent 2 new generations of transcatheter aortic valve implantation interventions with Sapien 3 and Evolut R valves. Patients underwent echocardiography before the procedure and at discharge, 6 months, and 1-year follow-up. Results: Of the 66 patients, 28 received Sapien 3 and 38 received Evolut R valves. Evolut R valve presented a lower mean gradient at all follow-up time points compared with Sapien 3 valves (14.4 mm Hg, 14.9 mm Hg, 15.5 mm Hg compared with 10.1 mm Hg, 11.6 mm Hg, 11.8 mm Hg, respectively; all P-values <0.001). Small valve sizes of Evolut R, including 23 and 26, had higher echocardiographic mean gradient or peak gradient at the time of discharge compared with larger valves, including sizes 29 and 34 (11.1 mm Hg and 11.2 mm Hg vs. 10.2 mm Hg, 9.1 mm Hg) and 1-year follow-up (11.0 mm Hg, 11.0 mm Hg vs. 9.9 mm Hg, 8.4 mm Hg; all P-values = 0.001). Although Sapien 3 valves demonstrated a higher peak gradient in smaller sizes at discharge (18.44 mm Hg in size 23 vs. 17.9 mm Hg, 16.5 mm Hg in size 26 and 29, respectively; P = 0.001), the peak gradients did not show a statistically significant difference in the 1-year follow-up. Conclusions: The current study detected significantly lower mean and peak gradients in Evolut R compared with Sapien 3 at all follow-up time points. Furthermore, smaller valve sizes were associated with significantly higher gradients at all follow-ups, regardless of the valve type.

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Meta-analysis of short- and long-term clinical outcomes of the self-expanding Evolut R/pro valve versus the balloon-expandable Sapien 3 valve for transcatheter aortic valve implantation

Cited by 10 publications

References 45 publications

Comparison of middle-term valve durability between transcatheter aortic valve implantation and surgical aortic valve replacement: an updated systematic review and meta-analysis of RCTs

Comparison of middle-term valve durability between transcatheter aortic valve implantation and surgical aortic valve replacement: an updated systematic review and meta-analysis of RCTs

Comparing outcomes of balloon-expandable vs. self-expandable valves in transcatheter aortic valve replacement: a systematic review and meta-analysis

Comparison of 1-year Follow-up Echocardiographic Outcomes of Sapien 3 Versus Evolut R Bioprosthetic Transcatheter Aortic Valves: A Single-center Retrospective Iranian Cohort Study

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