Evidence map›Paper›PMID 37462610›Full record

ArticleInterdisciplinary cardiovascular and thoracic surgery2023

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

Jérémy Bernard, Gabriel Georges, Sébastien Hecht, Philippe Pibarot, Marie-Annick Clavel, Shervin Babaki, Dimitri Kalavrouziotis, Siamak Mohammadi

Abstract read
In one paragraph

Article in Interdisciplinary cardiovascular and thoracic surgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  11. Performance and outcomes of the SAPIEN 3 Ultra RESILIA transcatheter heart valve in the OCEAN-TAVI registry.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Jérémy BernardCardiology Division, Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval/Quebec Heart and Lung Institute - Laval University, Quebec, QC, Canada.ORCID 0000-0002-0645-2636
Gabriel GeorgesCardiac Surgery Division, Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval/Quebec Heart and Lung Institute - Laval University, Quebec, QC, Canada.ORCID 0000-0002-7101-2960
Sébastien HechtCardiology Division, Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval/Quebec Heart and Lung Institute - Laval University, Quebec, QC, Canada.
Philippe PibarotCardiology Division, Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval/Quebec Heart and Lung Institute - Laval University, Quebec, QC, Canada.ORCID 0000-0002-3607-279X
Marie-Annick ClavelCardiology Division, Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval/Quebec Heart and Lung Institute - Laval University, Quebec, QC, Canada.ORCID 0000-0002-8924-740X
Shervin BabakiResearch Division, Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval/Quebec Heart and Lung Institute - Laval University, Quebec, QC, Canada.
Dimitri KalavrouziotisCardiac Surgery Division, Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval/Quebec Heart and Lung Institute - Laval University, Quebec, QC, Canada.
Siamak MohammadiCardiac Surgery Division, Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval/Quebec Heart and Lung Institute - Laval University, Quebec, QC, Canada.ORCID 0000-0001-7622-4172

Funding

CIHR
6 · The paper itself

Abstract

objectivesThe 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 Carpentier Edwards Perimount Magna Ease (ME).

methodsThis study was a retrospective single-centre study. Clinical results included early postoperative outcomes, mid-term mortality and readmission for cardiovascular cause or stroke. Echocardiographic follow-up (FU) was performed at discharge and 1-3, 6, 12 and 24 months. Clinical end point analyses were accomplished with a propensity score matching analysis and FU echocardiographic data comparisons using pairwise analyses and linear mixed-effect models.

resultsWe 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 mean transvalvular gradients compared to ME.

conclusionsThis 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 FU is underway.

Indexed as

INSPIRIS RESILIAMagna EasePatient–prosthesis mismatchStructural valve deteriorationSurgical aortic valve replacementTransvalvular gradient

Identifiers

PMID37462610
PMCPMC10386877

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.