10-Year Impact of Transcatheter Aortic Valve Replacement Leaflet Design (Intra- Versus Supra-Annular) in Mortality and Hemodynamic Performance

Scotti, Andrea; Fovino, Luca Nai; Coisne, Augustin; Fabris, Tommaso; Cardaioli, Francesco; Massussi, Mauro; Rodinò, Giulio; Barolo, Alberto; Boiago, Mauro; Continisio, Saverio; Montonati, Carolina; Sciarretta, Tommaso; Zuccarelli, Vittorio; Bernardini, Valentina; Masiero, Giulia; Napodano, Massimo; Fraccaro, Chiara; Marchese, Alfredo; Esposito, Giovanni; Granada, Juan F.; Latib, Azeem; Iliceto, Sabino; Tarantini, Giuseppe

doi:10.3389/fcvm.2022.924958

Cited by 14 publications

(5 citation statements)

References 33 publications

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“…Eleven studies with a total of 5458 patients were included in the survival analysis. 11,[13][14][15][16][17][18][19][20][21][22] One study was a randomized controlled trial and remaining 10 studies were observational. Five studies with 1509 patients were included in the analysis of freedom from SVD.…”

Section: Literature Selection Resultsmentioning

confidence: 99%

“…A total of 11,987 studies were identified, published from 2002 to 2016, after removal of duplicates and evaluation based on the selection criteria, 12 studies were included in the meta‐analysis (Figure 1). Eleven studies with a total of 5458 patients were included in the survival analysis 11,13–22 . One study was a randomized controlled trial and remaining 10 studies were observational.…”

Section: Resultsmentioning

confidence: 99%

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Long‐term outcomes after transcatheter aortic valve replacement: Meta‐analysis of Kaplan−Meier‐derived data

Shimamura,

Takemoto,

Fukuhara

et al. 2023

Cathet Cardio Intervent

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BackgroundTranscatheter aortic valve replacement (TAVR) is as an alternative treatment to surgical AVR, but the long‐term outcomes of TAVR remain unclear.AimsThis study aimed to analyze long‐term outcomes following TAVR using meta‐analysis.MethodsA literature search was performed with MEDLINE, EMBASE, Cochrane Library, Web of Science, and Google Scholar through November 2022; studies reporting clinical outcomes of TAVR with follow‐up periods of ≥8 years were included. The outcomes of interest were overall survival and/or freedom from structural valve deterioration (SVD). Surgical risk was assessed with the Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) score. A subgroup analysis was conducted for intermediate‐/high‐surgical risk patients only.ResultsEleven studies including 5458 patients were identified and analyzed. The mean age was 82.0 ± 6.5 years, and mean STS PROM score ranged from 2.9 to 10.6%. Survival rate at 5 and 10 years was 47.7% ± 1.4% and 12.1 ± 2.0%. Five studies including 1509 patients were analyzed for SVD. Freedom from SVD at 5 and 8 years was 95.5 ± 0.7% and 85.1 ± 3.1%. Similar results for survival and SVD were noted in the subgroup analysis of intermediate‐/high‐risk patients.ConclusionsFollowing TAVR, approximately 88% of patients died within 10 years, whereas 85% were free from SVD at 8 years. These date suggest that baseline patient demographic have the greatest impact on survival, and SVD does not seem to have a prognostic impact in this population. Further investigations on longer‐term outcomes of younger and lower‐risk patients are warranted.

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Section: Literature Selection Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Long‐term outcomes after transcatheter aortic valve replacement: Meta‐analysis of Kaplan−Meier‐derived data

Shimamura,

Takemoto,

Fukuhara

et al. 2023

Cathet Cardio Intervent

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“…Currently, self-expanding supra-annular valves are the preferred THV platform to reduce the risk of PPM in TAVR patients. Several studies have shown a lower incidence of moderate and severe PPM in self-expanding valves as compared to balloon-expanding valves [ 32 , 33 , 34 , 35 , 36 ]. In a large study comparing THV designs, patients who underwent TAVR with Evolut (self-expanding supra-annular valve) and Portico (self-expanding intra-annular valve) valves had similar increases in mean pressure gradients (7 mmHg) at 30 days post-TAVR despite the difference in positioning [ 35 ].…”

Section: Introductionmentioning

confidence: 99%

“…However, in patients with small and very small native annulus, rates of moderate PPM were significantly higher with the Portico intra-annular valves as compared to the Evolut supra-annular valves [ 36 ]. In another study, intra-annular devices resulted in higher rates of moderate PPM (17.7% vs. 8.9%, p < 0.05) and severe PPM (1.6% vs. 0%, p < 0.05) compared to supra-annular valves, but these data are from older THV models and ultimately had no impact on 10-year survival [ 33 ].…”

Section: Introductionmentioning

confidence: 99%

Transcatheter Aortic Valve Replacement for Failed Surgical or Transcatheter Bioprosthetic Valves: A Comprehensive Review

Groginski,

Mansour,

Kamal

et al. 2024

JCM

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Transcatheter aortic valve replacement (TAVR) has proven to be a safe, effective, and less invasive approach to aortic valve replacement in patients with aortic stenosis. In patients who underwent prior aortic valve replacement, transcatheter and surgical bioprosthetic valve dysfunction may occur as a result of structural deterioration or nonstructural causes such as prosthesis–patient mismatch (PPM) and paravalvular regurgitation. Valve-in-Valve (ViV) TAVR is a procedure that is being increasingly utilized for the replacement of failed transcatheter or surgical bioprosthetic aortic valves. Data regarding long-term outcomes are limited due to the recency of the procedure’s approval, but available data regarding the short- and long-term outcomes of ViV TAVR are promising. Studies have shown a reduction in perioperative and 30-day mortality with ViV TAVR procedures compared to redo surgical repair of failed bioprosthetic aortic valves, but 1-year and 5-year mortality rates are more controversial and lack sufficient data. Despite the reduction in 30-day mortality, PPM and rates of coronary obstruction are higher in ViV TAVR as compared to both redo surgical valve repair and native TAVR procedures. New transcatheter heart valve designs and new procedural techniques have been developed to reduce the risk of PPM and coronary obstruction. Newer generation valves, new procedural techniques, and increased operator experience with ViV TAVR may improve patient outcomes; however, further studies are needed to better understand the safety, efficacy, and durability of ViV TAVR.

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“…[3][4][5][6] The main strengths of these devices are the self-expanding mechanism, allowing valve recapture and repositioning, and the valve frame with supra-annular leaflet design, leading to optimal and sustained hemodynamic performance. 7,8 Drawbacks of the valve include higher rates of significant paravalvular leak (PVL) and need for permanent pacemaker implantation (PPI), which have a significant impact on short-and long-term outcomes, including increased mortality. [9][10][11][12] Technological refinements aimed at reducing complication rates led to the conception of the Evolut PRO and PRO+ devices.…”

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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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10-Year Impact of Transcatheter Aortic Valve Replacement Leaflet Design (Intra- Versus Supra-Annular) in Mortality and Hemodynamic Performance

Cited by 14 publications

References 33 publications

Long‐term outcomes after transcatheter aortic valve replacement: Meta‐analysis of Kaplan−Meier‐derived data

Long‐term outcomes after transcatheter aortic valve replacement: Meta‐analysis of Kaplan−Meier‐derived data

Transcatheter Aortic Valve Replacement for Failed Surgical or Transcatheter Bioprosthetic Valves: A Comprehensive Review

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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