Impact of left ventricle outflow tract calcification on the outcomes of transcatheter aortic valve implantation: A study‐level meta‐analysis

Sá, Michel Pompeu Barros de Oliveira; Eynde, Jef Van den; Malin, John H.; Torregrossa, Gianluca; Sicouri, Serge; Ramlawi, Basel

doi:10.1111/jocs.16306

Cited by 16 publications

(11 citation statements)

References 33 publications

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“…The Achilles heel of SURD valves is the bioprosthetic positioning in the noncoronary sinus, which requires particular attention from the surgeon to avoid PVL. With respect to TAVI procedures, the PVL incidence is dependent on various factors such as the presence and severity of left ventricle outflow tract calcification 43 and the correct choice of SEV or BEV. 44 However, this meta-analysis revealed a higher incidence of PVL in the TAVI group (p ˂ .001).…”

Section: Commentsmentioning

confidence: 99%

Early and late outcomes of surgical aortic valve replacement with sutureless and rapid‐deployment valves versus transcatheter aortic valve implantation: Meta‐analysis with reconstructed time‐to‐event data of matched studies

Sá

Jabagi²,

Dokollari

et al. 2022

Cathet Cardio Intervent

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Sutureless/rapid-deployment (SURD) valves are options different from the stented prostheses included in the pivotal trials comparing surgical aortic valve replacement (AVR) and transcatheter aortic valve implantation (TAVI). We performed a metaanalysis with reconstructed time-to-event data of matched studies published by November 2021 to compare SURD-AVR and TAVI. Primary endpoints were 30-day mortality and overall survival in the follow-up. Secondary endpoints included: 30-day stroke, acute kidney injury (AKI), major bleeding, permanent pacemaker implantation (PPI), paravalvular leak (PVL), prosthesis-patient mismatch (PPM), postoperative aortic valve area (AVA), and mean gradients. Ten studies met our eligibility criteria, including a total of 5134 patients (2567 underwent SURD-AVR and 2567 underwent TAVI). Pooled risk of 30-day mortality did not favor any group (odds ratio [OR]: 0.69; 95% confidence interval [CI]: 0.31-1.53; p = 0.360). Patients undergoing SURD-AVR had lower risk of PVL (OR: 0.09; 95% CI: 0.05-0.17; p < 0.001). No statistically significant differences were observed for 30-day stroke, AKI, major bleeding, PPI, PPM, and postoperative AVA. In the follow-up, we observed a higher risk of mortality (hazard ratio: 1.74; 95% CI: 1.26-2.40; p < 0.001) with TAVI. Patients who underwent SURD-AVR experienced better survival, however, the interpretation of these results warrant caution due to the fact that SURD-AVR patients tended to be younger than TAVI patients. Structural heart surgeons and interventional cardiologists should consider initial risk and life expectancy when referring patients for one approach over the other.

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Section: Commentsmentioning

confidence: 99%

Early and late outcomes of surgical aortic valve replacement with sutureless and rapid‐deployment valves versus transcatheter aortic valve implantation: Meta‐analysis with reconstructed time‐to‐event data of matched studies

Sá

Jabagi²,

Dokollari

et al. 2022

Cathet Cardio Intervent

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“…The studies did not report what types of valves were used and, unfortunately, we were unable to run sensitivity analyses for some dichotomies (early‐ vs. new‐generation devices; BEVs vs. SEV 5 ; bioprosthetic vs. mechanical valves). An aspect poorly explored in the studies is the impact of left ventricle outflow tract calcification on the outcomes of TAVI, 35 thus, we were unable to investigate if this feature had any effect on our findings.…”

Section: Discussionmentioning

confidence: 90%

Immediate and late outcomes of transcatheter aortic valve implantation versus surgical aortic valve replacement in bicuspid valves: Meta‐analysis of reconstructed time‐to‐event data

Sá

Jacquemyn

Tasoudis

et al. 2022

Journal of Cardiac Surgery

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Background Outcomes of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) in patients with aortic stenosis and bicuspid aortic valve (BAV) must be better investigated. Methods A meta‐analysis including studies published by January 2022 reporting immediate outcomes (in‐hospital death, stroke, acute kidney injury [AKI], major bleeding, new permanent pacemaker implantation [PPI], paravalvular leakage [PVL]), mortality in the follow‐up (with Kaplan–Meier curves for reconstruction of individual patient data). Results Five studies met our eligibility criteria. No statistically significant difference was observed for in‐hospital death, stroke, AKI, and PVL. TAVI was associated with lower risk of major bleeding (odds ratio [OR]: 0.29; 95% confidence interval [CI]: 0.12–0.69; p = .025), but higher risk of PPI (OR: 2.00; 95% CI: 1.05–3.77; p = .041). In the follow‐up, mortality after TAVI was significantly higher in the analysis with the largest samples (HR: 1.24, 95% CI: 1.01–1.53, p = .043), but no statistically significant difference was observed with risk‐adjusted populations (HR: 1.06, 95% CI: 0.86–1.32, p = .57). Landmark analyses suggested a time‐varying risk with TAVI after 10 and 13 months in both largest and risk‐adjusted populations (HR: 2.13, 95% CI: 1.45–3.12, p < .001; HR: 1.7, 95% CI: 1.11–2.61, p = .015, respectively). Conclusion Considering the immediate outcomes and comparable overall survival observed in risk‐adjusted populations, TAVI can be used safely in selected BAV patients. However, a time‐varying risk is present (favoring SAVR over TAVI at a later timepoint). This finding was likely driven by higher rates of PPI with TAVI.

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“…Approximately one-fifth of the study population had moderate or heavy left ventricular outflow tract calcifications, a scenario in which SEV are a preferrable option. 26 Despite the treatment of more complex anatomies, from 2017 through 2021, VARC-3 defined technical success and intended performance of the valve remained high and stable (Q4, 94% and 95%, respectively), with VARC-3 device success and early safety that even improved to 88% and 78%, respectively. These findings compare favorably with contemporary registries on TAVR 27 and will represent an important reference for future experiences in TAVR using SEV.…”

Section: Discussionmentioning

confidence: 99%

Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries

Scotti

Baggio

Pagnesi

et al. 2023

Circ: Cardiovascular Interventions

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Background: In recent years, transcatheter aortic valve replacement (TAVR) techniques and technology have continuously improved. Data regarding the impact of these advancements on outcomes in large real-world settings are still limited. The aim of this study was to investigate temporal trends and assess contemporary outcomes after TAVR with Evolut PRO/PRO+ supra-annular self-expanding valves. Methods: This study included patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries who underwent transfemoral TAVR with Evolut PRO/PRO+. Procedural dates (August 2017 through November 2021) were stratified in quartiles (Q) and used to investigate temporal trends in TAVR outcomes. Predischarge, 30-day Valve Academic Research Consortium-3 defined, and 1-year outcomes were evaluated. Results: In total, 1616 patients from 28 centers were included. Over time, patients had lower Society of Thoracic Surgeon-Predicted Risk of Mortality score (Q1–4, 4.1% [2.8–6.3%], 3.7% [2.6–5.3%], 3.3% [2.4–4.9%], 2.9% [2.2–4.3%]; P <0.001) and more moderate or heavy valve calcification (Q1–4, 80%, 80%, 82%, 88%; P =0.038). Overall Valve Academic Research Consortium-3 technical success was 94.1%, with 30-day and 1-year all-cause mortality of 2.4% and 10%, respectively. Throughout the study period, procedures were associated with higher rates of 30-day device success (Q1–4, 81.2%, 82.2%, 82.0%, 88.0%; Cochran-Armitage P =0.023) and early safety (Q1–4, 66.8%, 67.5%, 74.0%, 77.6%; Cochran-Armitage P <0.001), with fewer permanent pacemaker implantations (Q1–4: 15.3%, 20.0%, 12.1%, 11.6%; Cochran-Armitage P =0.023) and residual mild or greater paravalvular leaks (Q1–4, 50.4%, 42.1%, 36.5%, 35.8%; Cochran-Armitage P <0.001). Conclusions: TAVR with Evolut PRO/PRO+ self-expanding valve is safe and effective. Despite the treatment of heavier calcified anatomies, procedural outcomes are improving over time with less need for pacemaker implantation and less significant paravalvular leaks.

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Impact of left ventricle outflow tract calcification on the outcomes of transcatheter aortic valve implantation: A study‐level meta‐analysis

Cited by 16 publications

References 33 publications

Early and late outcomes of surgical aortic valve replacement with sutureless and rapid‐deployment valves versus transcatheter aortic valve implantation: Meta‐analysis with reconstructed time‐to‐event data of matched studies

Early and late outcomes of surgical aortic valve replacement with sutureless and rapid‐deployment valves versus transcatheter aortic valve implantation: Meta‐analysis with reconstructed time‐to‐event data of matched studies

Immediate and late outcomes of transcatheter aortic valve implantation versus surgical aortic valve replacement in bicuspid valves: Meta‐analysis of reconstructed time‐to‐event data

Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries

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