Safety and performance parameters of the Myval transcatheter aortic valve bioprosthesis: The SAPPHIRE prospective registry

Testa, Luca; Criscione, Enrico; Rubbio, Antonio Popolo; Squillace, Mattia; Ielasi, Alfonso; Tespili, Maurizio; Brambilla, Nedy; Bedogni, Francesco

doi:10.1016/j.carrev.2023.04.014

Cited by 11 publications

(2 citation statements)

References 23 publications

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“…In the present study, all-cause and cardiovascular mortality, as well as stroke and TIA rates, were in line with the other real world setting studies, during the entire follow-up period. [ 5 , 11 – 16 ]. Beside the primary endpoint, The Myval THV showed very high technical (99%) and device success (91%), with very good clinical efficacy (79%), and early safety (78%).…”

Section: Discussionmentioning

confidence: 99%

“…However, this study was done in low-risk patients, VARC3 criteria were not used and the follow-up period was restricted to only 30 days. A recent study, the SAPPHIRE prospective registry, by Testa et al [ 5 ], that evaluated 100 consecutive patients from two Italian centres, who underwent TAVI for SAS, reported a successful implantation of the Myval, with no in-hospital mortality and 99% device success. Overall and CVD mortality rates observed in the SAPPHIRE registry were also similar to our study, both at 1-year and at 2-year follow-up.…”

Section: Discussionmentioning

confidence: 99%

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Clinical outcomes of the Myval transcatheter heart valve system in patients with severe aortic valve stenosis: a two-year follow-up observational study

Kilic,

Ielasi,

Ninios

et al. 2024

Arch Med Sci

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IntroductionLimited data exist on long-term follow-up of severe aortic stenosis (SAS) patients who have undergone transcatheter aortic valve implantation (TAVI) with a new generation, balloon expandable Myval transcatheter heart valve (THV). Thus, we sought to investigate the performance and 2-year clinical outcome of the Myval THV system based on Valve Academic Research Consortium-3 (VARC-3) criteria.Material and methodsA multi-centre, registry-based, observational study was conducted, which included 207 consecutive degenerative SAS patients, from Turkey (n = 128), Italy (n = 58), and Greece (n = 21) (mean [standard deviation] 81 (7) years, 94 [45%] men; 73% NYHA III or IV; EuroSCORE II 5.2% [2.4%]); all patients underwent TAVI with Myval. Patients were followed up at 1 year and 2 years after implantation. Clinical and procedural outcomes were defined according to VARC-3 criteria.ResultsTechnical success was observed in 204 (99%), device success was observed in 189 (91%), early safety was observed in 161 (78%), and clinical efficacy was observed in 163 (79%) patients. The 30-day death rate was 7.7%; of these, 3.4% were due to cardiovascular reasons. All-cause and cardiovascular mortality rates were 9.7% and 4.3% at 1-year follow-up, and 17.4% and 9.7% at 2-year follow-up, respectively. Incidence of ≥ moderate paravalvular leak (PVL) at 30 days, 1 year and 2 years of follow-up were 3.4%, 4.3% and 4.8%. A total of 11.1% of patients required a permanent pacemaker implantation (PPI) at 30 days after implantation, while the cumulative rate of PPI at 2 years was 12.1%.ConclusionsIn this cohort of patients with SAS, the Myval was found to be safe and effective in up to 2 years of follow-up.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%