Hemodynamic performance of INSPIRIS RESILIA aortic bioprosthesis for severe aortic stenosis: 2-year follow-up in Japanese cohort

Fukunaga, Naoto; Yoshida, Soshi; Shimoji, Akio; Maeda, Toshi; Mori, Otohime; Yoshizawa, Kosuke; Okada, Takamitsu; Tamura, Nobushige

doi:10.1007/s10047-022-01316-5

Cited by 6 publications

(3 citation statements)

References 15 publications

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“…Magna), but other studies should investigate this hypothesis. This is consistent with Fukunaga et al who evaluate its haemodynamic performance in only 29 Japanese patients treated with the INSPIRIS [ 17 ]. Larger studies with larger FU may demonstrate sustained better performance at long term.…”

Section: Discussionsupporting

confidence: 91%

Mid-term clinical and echocardiographic results of the INSPIRIS RESILIA aortic valve: a retrospective comparison to the Magna Ease

Bernard

Georges

Hecht

et al. 2023

Interdisciplinary CardioVascular and Thoracic Surgery

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OBJECTIVES The INSPIRIS aortic valve combines the RESILIA proprietary tissue preservation process and an expandable stent frame to benefit future transcatheter valve-in-valve procedures. As the INSPIRIS valve became commercially available in 2017, mid-term outcome reports are scarce. We aimed to evaluate mid-term safety and echocardiographic performance of the INSPIRIS valve in comparison to its predecessor, the Magna Ease (ME). METHODS This study was a retrospective single-center study. Clinical results included early post-operative outcomes, mid-term mortality and readmission for cardiovascular cause or stroke. Echocardiographic follow-up was performed at discharge, 1-3 months, 6, 12 and 24 months. Clinical end-points analyses were accomplished with a propensity score matching analysis and follow-up echocardiographic data comparisons using pairwise analyses and linear-mixed effect models. RESULTS We included 953 patients who received an INSPIRIS (n = 488) or ME (n = 463) bioprosthesis between January 2018 and July 2021. In the matched population (n = 217 per group), no significant difference in short-term outcomes was observed, survival was similar at 30-months (INSPIRIS: 94% vs ME: 91%, p = 0.89), but freedom from readmission was higher in the INSPIRIS group (94% vs 86%, p = 0.014). INSPIRIS valves had a lower gradient at discharge (∼10 vs 14 mmHg, p < 0.001), 1-3 months (∼10 vs 12 mmHg, p < 0.001) and 24-months (∼11 vs 17 mmHg, p < 0.001) in paired analyses and significantly lower evolution of MG compared to ME. CONCLUSIONS This study represents the largest comparative evaluation of the INSPIRIS to the ME valves, which demonstrated safe clinical outcomes and favourable haemodynamic performance at 2 years. Long-term follow-up is underway.

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Section: Discussionsupporting

confidence: 91%

Mid-term clinical and echocardiographic results of the INSPIRIS RESILIA aortic valve: a retrospective comparison to the Magna Ease

Bernard

Georges

Hecht

et al. 2023

Interdisciplinary CardioVascular and Thoracic Surgery

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“…In-hospital all-cause mortality rate in our study (0.7%) was lower than the rates reported in the trials by Useini (2.5%) and Fukunaga (3.4%), which both evaluated hospital outcomes after AVR using the INSPIRIS RESILIA bioprosthesis in smaller cohorts [ 10 , 12 ]. The reported in-hospital mortality rates for the Carpentier-Edwards Perimount Magna Ease bioprosthesis with RESILIA tissue range between 1.2% and 2.3% [ 7 , 8 ].…”

Section: Discussioncontrasting

confidence: 85%

“…The findings from a single-arm registry and the COMMENCE trial have shown excellent safety and effectiveness at 5 years, with no structural valve deterioration (SVD) [ 7 , 11 ]. The INSPIRIS RESILIA valve has also demonstrated improved haemodynamic performance in early results of smaller cohorts [ 10 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years — 1-year follow-up from the prospective INDURE registry

Meuris¹,

Roussel

Borger

et al. 2023

Interdisciplinary CardioVascular and Thoracic Surgery

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Objectives We report 1-year safety and clinical outcomes in patients <60 years undergoing bioprosthetic surgical aortic valve intervention. Methods The INSPIRIS RESILIA Durability Registry (INDURE) is a prospective, multicentre registry to assess clinical outcomes of patients <60 years. Patients with planned SAVR with or without concomitant replacement of the ascending aorta and/or coronary bypass surgery were included. Time-related valve safety, haemodynamic performance, and quality of life (QoL) at 1 year were assessed. Results 421 patients were documented with a mean age of 53.5 years, 76.5% being male, and 27.2% in NYHA class III/IV. Outcomes within 30 days included cardiovascular-related mortality (0.7%), time-related valve safety (VARC-2; 5.8%), thromboembolic events (1.7%), valve-related life-threatening bleeding (VARC-2; 4.3%), and permanent pacemaker implantation (3.8%). QoL was significantly increased at 6 months and sustained at 1 year. Freedom from all-cause mortality at 1 year was 98.3% (95%CI 97.1;99.6) and 81.8% were NYHA I vs. 21.9% at baseline. No patient developed structural valve deterioration Stage 3 (VARC-3). Mean aortic pressure gradient was 12.6 mmHg at 1 year and effective orifice area was 1.9 cm2. Conclusions The 1-year data from the INSPIRIS RESILIA valve demonstrate good safety and excellent haemodynamic performance as well as an early QoL improvement. ClinicalTrials number NCT03666741

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Midterm outcomes after surgical aortic valve replacement with the INSPIRIS RESILIA from a multicenter AVR registry

Maeda

Shimamura

Yoshioka

et al. 2023

Journal of Cardiology

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Hemodynamic performance of INSPIRIS RESILIA aortic bioprosthesis for severe aortic stenosis: 2-year follow-up in Japanese cohort

Cited by 6 publications

References 15 publications

Mid-term clinical and echocardiographic results of the INSPIRIS RESILIA aortic valve: a retrospective comparison to the Magna Ease

Mid-term clinical and echocardiographic results of the INSPIRIS RESILIA aortic valve: a retrospective comparison to the Magna Ease

Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years — 1-year follow-up from the prospective INDURE registry

Midterm outcomes after surgical aortic valve replacement with the INSPIRIS RESILIA from a multicenter AVR registry

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