Rationale and design of a randomized clinical trial comparing safety and efficacy of myval transcatheter heart valve versus contemporary transcatheter heart valves in patients with severe symptomatic aortic valve stenosis: The LANDMARK trial

Kawashima, Hideyuki; Soliman, Osama Ibrahim Ibrahim; Wang, Rutao; Ono, Masafumi; Hara, Hironori; Gao, Chao; Zeller, Emeline; Thakkar, Ashokkumar; Tamburino, Corrado; Bedogni, Francesco; Neumann, Franz‐Josef; Thiele, Holger; Abdel‐Wahab, Mohamed; Morice, Marie‐Claude; Webster, Mark; Rosseel, Liesbeth; Mylotte, Darren; Onuma, Yoshinobu; Wijns, William; Baumbach, Andreas

doi:10.1016/j.ahj.2020.11.001

Cited by 34 publications

(30 citation statements)

References 43 publications

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“…In the prospective RESPOND study, the qAR displayed a good relationship with the Core Laboratory-adjudicated echocardiographic, providing a more granular discrimination of regurgitation within the same strata of regurgitation as assessed by echocardiography [15]. Furthermore, this qAR is used as part of the primary composite end-point in the study protocol of the randomized LANDMARK trial (NCT04275726), comparing the Myval THV with the Evolut and Sapien 3 THV series [20].…”

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confidence: 99%

Paravalvular Aortic Regurgitation Severity Assessed by Quantitative Aortography: ACURATE neo2 versus ACURATE neo Transcatheter Aortic Valve Implantation

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Kim

Kawashima

et al. 2021

JCM

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The new-generation ACURATE neo2 system was commercially released in September 2020. In this study, we sought to compare the aortic regurgitation (AR) severity of the ACURATE neo2 versus the ACURATE neo transcatheter heart valve, using quantitative videodensitometric angiography (qAR). This is a retrospective, Corelab analysis of final post-transcatheter aortic valve implantation (TAVI) aortograms of patients treated with the ACURATE neo2 and ACURATE neo systems. The ACURATE neo2 cohort comprised consecutive patients treated between September 2020 and January 2021 at two centers. The ACURATE neo cohort included consecutive patients treated before September 2020. Our primary objective was to compare AR severity on qAR following TAVI with ACURATE neo2 and ACURATE neo. Out of 401 aortograms, 228 (56.9%) were analyzable, with 120 in the ACURATE neo2 cohort, and 108 in the ACURATE neo cohort. The mean AR fraction was 4.4 ± 4.8% in the neo2 cohort, and 9.9 ± 8.2% in the neo cohort (p < 0.001). Furthermore, moderate or severe AR (qAR > 17%) was detected in 2 aortograms (1.7%) in the neo2 cohort and 15 aortograms (13.9%) in the neo cohort (p < 0.001). Quantitative aortography shows a lower rate of moderate or severe paravalvular AR in what is the first European experience of the new-generation, self-expanding ACURATE neo2 when compared to the first-generation ACURATE neo. Moreover, aortographic data need to be correlated and compared to Core Laboratory-adjudicated 30-day echocardiographic data.

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Section: Discussionmentioning

confidence: 99%

Paravalvular Aortic Regurgitation Severity Assessed by Quantitative Aortography: ACURATE neo2 versus ACURATE neo Transcatheter Aortic Valve Implantation

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Kim

Kawashima

et al. 2021

JCM

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“…Finally, the durability of the three BEVs was not investigated. However, the durability of the Myval THV, Sapien THV and Evolut THV series up to 10 years will be investigated in the ongoing randomized LANDMARK trial (ClinicalTrials.govNCT04275726, EudraCT number 2020-000137-40) [10]. This trial will provide useful information on the long-term durability of the devices.…”

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Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves

et al. 2021

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Objectives: The aim of the present analysis is to compare the quantitative angiographic aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) among three balloonexpandable valves. Background: Quantitative videodensitometric aortography is an objective, accurate, and reproducible tool for adjudication of AR following TAVI. Methods: This is a retrospective corelab analysis, independent from industry, of aortograms from patients treated with TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., India), Sapien 3, and XT THVs (Edwards Lifesciences, Irvine, CA, USA). The study comprised of 108 analyzable aortograms from consecutive patients in a multicenter European registry who underwent Myval THV implantation. The results of quantitative assessment of AR in the Sapien 3 THV (n = 397) and Sapien XT THV (n = 239) were retrieved from a published pooled database. Results: The Myval THV had the lowest proportion of patients with moderate or severe angiographic quantitative AR (2.8%) compared to the Sapien 3 THV (8.3%; p = 0.049) and Sapien XT THV (10.9%; p = 0.012). Furthermore, the Myval THV had the lowest mean angiographic quantitative AR (6.3 ± 6.3%), followed by Sapien 3 THV (7.6 ± 7.1%) and Sapien XT THV (8.8 ± 7.5%), and it was significantly lower than that of the Sapien XT THV (p = 0.006), but not significantly different from Sapien 3 THV (p = 0.246). Conclusion: The Myval THV, in comparison with other BEV's analyzed in our database, showed a lower occurrence of moderate or severe AR after TAVI. These results should be confirmed in prospective cohorts of randomized patients with head-to-head THV comparisons.

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“…The availability of the intermediate-size THVs could mitigate the hazardous selection of grossly undersized or oversized valve, thereby reducing PVR, conduction disturbances as well as lifethreatening aortic annular rupture. Our hypothesis should be tested in randomized prospective studies currently initiated in Europe including clinical outcomes of patients treated with both conventional-and intermediate-size THVs [10].…”

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Operator preference and determinants of size selection when additional intermediate-size aortic transcatheter heart valves are made available

Kawashima

Serruys

Mylotte

et al. 2021

International Journal of Cardiology

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Background: Appropriate size selection of transcatheter heart valves (THVs) is fundamental to reduce transcatheter aortic valve implantation (TAVI) related complications, particularly paravalvular aortic regurgitation, new permanent pacemaker implantation, and annular rupture. We sought to investigate the frequency of operator selection of intermediate-size balloon-expandable Myval THVs (Meril Life Sciences Pvt. Ltd., India) for TAVI in a real-world dataset. Methods: In this retrospective survey of patients treated with TAVI using the Myval THV, 20, 23, 26, and 29 mm are conventional-size THVs, 21.5, 24.5 and 27.5 mm are intermediate-size THVs, and 30.5 and 32 mm are extralarge THVs. Operator size selection for implantation was based on multislice computed tomography (MSCT) derived aortic-root dimensions. Results: A total of 1115 patients underwent Myval THV implantation in 27 countries worldwide. The Myval intermediate-size THVs were used in 468 (42.0%) patients. MSCT data were available in 562 patients. There was no statistical difference between the Intermediate/Upsized and Appropriately sized groups or Intermediate/Downsized and Appropriately sized groups in terms of different variables measured with MSCT except for annular dimensions and degree of calcification. Conclusions: Intermediate-size Myval balloon-expandable THVs are used in nearly half of all cases in contemporary real-world TAVI practice, addressing the unmet need of TAVI operators for a more calibrated THV choice. Our hypothesis should be tested in randomized prospective studies currently initiated in Europe, including clinical outcomes of patients treated with both conventional-and intermediate-size THVs.

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Rationale and design of a randomized clinical trial comparing safety and efficacy of myval transcatheter heart valve versus contemporary transcatheter heart valves in patients with severe symptomatic aortic valve stenosis: The LANDMARK trial

Cited by 34 publications

References 43 publications

Paravalvular Aortic Regurgitation Severity Assessed by Quantitative Aortography: ACURATE neo2 versus ACURATE neo Transcatheter Aortic Valve Implantation

Paravalvular Aortic Regurgitation Severity Assessed by Quantitative Aortography: ACURATE neo2 versus ACURATE neo Transcatheter Aortic Valve Implantation

Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves

Operator preference and determinants of size selection when additional intermediate-size aortic transcatheter heart valves are made available

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