Haemodynamic performance and clinical outcomes of transcatheter aortic valve replacement with the self-expanding ACURATE neo2

Scotti, Andrea; Pagnesi, Matteo; Kim, Won-Keun; Schäfer, Ulrich; Barbanti, Marco; Costa, Giuliano; Baggio, Sara; Casenghi, Matteo; Marco, Federico De; Vanhaverbeke, Maarten; Søndergaard, Lars; Wolf, Alexander; Schöfer, Joachim; Ancona, Marco; Montorfano, Matteo; Kornowski, Ran; Assa, Hana Vaknin; Toggweiler, Stefan; Ielasi, Alfonso; Hildick‐Smith, David; Windecker, Stephan; Schmidt, Albrecht; Buono, Andrea; Maffeo, Diego; Siqueira, Dimytri; Giannini, Francesco; Adamo, Marianna; Massussi, Mauro; Wood, David; Sinning, Jan‐Malte; Heyden, Jan Van der; Ginkel, Dirk‐Jan van; Mieghem, Nicholas Van; Veulemans, Verena; Mylotte, Darren; Tzalamouras, Vasileios; Taramasso, Maurizio; Estévez‐Loureiro, Rodrigo; Colombo, Antonio; Mangieri, Antonio; Latib, Azeem

doi:10.4244/eij-d-22-00289

Cited by 26 publications

(17 citation statements)

References 21 publications

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“…17 Subsequently, the NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registry was designed to expand the analyzed population including procedures performed with the new-generation ACURATE neo2 (n=763) and Evolut PRO (n=1254) or PRO+ (n=158) devices between August 2017 and December 2021 at 20 international centers (North America, Western Asia, and Europe). 18,19 All consecutive patients treated with transfemoral TAVR with the above-mentioned SEV for symptomatic severe aortic stenosis of the native aortic valve (AV) were included in the registries.…”

Section: Methodsmentioning

confidence: 99%

“…17 WHAT THE STUDY ADDS neo2 (n=763) and Evolut PRO (n=1254) or PRO+ (n=158) devices between August 2017 and December 2021 at 20 international centers (North America, Western Asia, and Europe). 18,19 All consecutive patients treated with transfemoral TAVR with the above-mentioned SEV for symptomatic severe aortic stenosis of the native aortic valve (AV) were included in the registries.…”

Section: Study Populationmentioning

confidence: 99%

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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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Section: Methodsmentioning

confidence: 99%

Section: Study Populationmentioning

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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“…12 However, while the PVL rate of the ACURATE neo2 valve in this study is lower than that of the ACURATE neo, it is slightly higher than reported in other similar studies. 10,11,14,15 Several reasons may explain these findings. First, this study reflects the initial experience of multiple centers with the ACURATE neo2 valve.…”

Section: Comparison Between Trans-femoral and Non-transfemoral Proced...mentioning

confidence: 99%

Experience with the ACURATE neo and neo2 transcatheter aortic valves in Spain. The PRECISA (PRospective Evaluation Complementing Investigation with ACURATE devices) registry

Tébar,

Carrillo,

García del Blanco

et al. 2024

Cathet Cardio Intervent

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BackgroundPrevious studies have documented a high rate of implantation success with the ACURATE neo2 valve, as well as a reduction in paravalvular leak (PVL) compared to its predecessor, the ACURATE neo. However, there are no studies that have reviewed and compared the long‐term clinical and hemodynamic outcomes of these patients.AimsThis study aimed to evaluate the results of the ACURATE neo transcatheter aortic valve in a real‐world context, and to compare the results of the outcomes of both generations of this device (ACURATE neo and ACURATE neo2), with a specific focus on procedural success, safety, and long‐term effectiveness.MethodsA prospective study including all consecutive patients treated with the ACURATE neo device in seven hospitals was conducted (Clinical Trials Identification Number: NCT03846557). The primary endpoint consisted of a composite of adverse events, including mortality, aortic insufficiency, and other procedural complications. As the second‐generation device (ACURATE neo2) replaced the ACURATE neo during the study period, hemodynamic and clinical results before admission, at 30 days, and at 1 year of follow‐up were compared between the two generations.ResultsA total of 296 patients underwent transcatheter aortic valve implantation with the ACURATE device, with 178 patients receiving the ACURATE neo and 118 patients receiving the ACURATE neo2. In the overall population, the absence of device success occurred in 14.5%. The primary reason for the absence of device success was the presence of para‐valvular regurgitation ≥ 2. There were no instances of coronary occlusions, valve embolization, annulus rupture, or procedural deaths. ACURATE neo2 was associated with a significantly higher device success rate (91.7% vs. 82%, p = 0.04), primarily due to a significantly lower rate of para‐valvular regurgitation, which remained significant at 1 year.ConclusionThe use of ACURATE neo and neo2 transcatheter aortic valves is associated with satisfactory clinical results and an extremely low rate of complications. The ACURATE neo2 enables a significantly higher device success rate, primarily attributed to a significant reduction in the rate of PVL.

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“…Also, ACURATE-neo was a first-generation device and data from Europe have shown a significant decrease in PVL with the second generation ACURATE-neo2, which has pericardial skirt sutured on the inner and outer surface of the stent to decrease or prevent PVL. 7 The ACURATE IDE randomized trial has just completed enrollment in the United States and its early and mid-term data will provide a better picture of whether the ACURATE-neo2 performance will be comparable to the SAPIEN-3 or EVOLUT-PRO/PRO+ devices. Future design of the ACURATE prime may further reduce PVL in challenging anatomies (Figure).…”

Section: Limitations Of the Scope-1 Study And Future Directionsmentioning

confidence: 99%

Revisiting the ACURATE-Neo Valve: Slow Starter But a Hopeful Finisher?

Krishnamoorthy

2023

Circ: Cardiovascular Interventions

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Haemodynamic performance and clinical outcomes of transcatheter aortic valve replacement with the self-expanding ACURATE neo2

Cited by 26 publications

References 21 publications

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

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

Experience with the ACURATE neo and neo2 transcatheter aortic valves in Spain. The PRECISA (PRospective Evaluation Complementing Investigation with ACURATE devices) registry

Revisiting the ACURATE-Neo Valve: Slow Starter But a Hopeful Finisher?

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