Evidence map›Paper›PMID 35207232›Full record

ArticleJournal of clinical medicine2022

Clinical Comparison of a Novel Balloon-Expandable Versus a Self-Expanding Transcatheter Heart Valve for the Treatment of Patients with Severe Aortic Valve Stenosis: The EVAL Registry.

Monica Barki, Alfonso Ielasi, Andrea Buono, Gabriele Maliandi, Mariano Pellicano, Marta Bande, Francesco Casilli, Francesca Messina, Giuseppe Uccello, Daniele Briguglia and 3 more

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 4 pooled it
4.9field-weighted citation impact, top 4% of its field
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

23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 32 citations in OpenAlex.

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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

13 authors at 2 institutions in 1 country.

Monica BarkiClinical and Interventional Unit, Istituto Clinico Sant'Ambrogio, 20149 Milan, Italy.
Alfonso IelasiClinical and Interventional Unit, Istituto Clinico Sant'Ambrogio, 20149 Milan, Italy.ORCID 0000-0002-5982-1669
Andrea BuonoClinical and Interventional Unit, Istituto Clinico Sant'Ambrogio, 20149 Milan, Italy.ORCID 0000-0001-5767-7416
Gabriele MaliandiClinical and Interventional Unit, Istituto Clinico Sant'Ambrogio, 20149 Milan, Italy.
Mariano PellicanoClinical and Interventional Unit, Istituto Clinico Sant'Ambrogio, 20149 Milan, Italy.ORCID 0000-0002-9637-0959
Marta BandeClinical and Interventional Unit, Istituto Clinico Sant'Ambrogio, 20149 Milan, Italy.
Francesco CasilliClinical and Interventional Unit, Istituto Clinico Sant'Ambrogio, 20149 Milan, Italy.
Francesca MessinaClinical and Interventional Unit, Istituto Clinico Sant'Ambrogio, 20149 Milan, Italy.
Giuseppe UccelloClinical and Interventional Unit, Istituto Clinico Sant'Ambrogio, 20149 Milan, Italy.ORCID 0000-0002-6163-8468
Daniele BrigugliaClinical and Interventional Unit, Istituto Clinico Sant'Ambrogio, 20149 Milan, Italy.
Massimo MeddaClinical and Interventional Unit, Istituto Clinico Sant'Ambrogio, 20149 Milan, Italy.
Maurizio TespiliClinical and Interventional Unit, Istituto Clinico Sant'Ambrogio, 20149 Milan, Italy.
Francesco DonatelliCardiac Surgery, Department of Cardiothoracic Center, Istituto Clinico Sant'Ambrogio, University of Milan, 20122 Milan, Italy.ORCID 0000-0003-2839-0373
Istituto Clinico Sant'Ambrogio · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTranscatheter aortic valve replacement (TAVR) is an effective treatment option for patients with severe, symptomatic AS, regardless of the transcatheter heart valve (THV) implanted. Prior studies demonstrated a higher device success with lower paravalvular leak (PVL) using the balloon-expandable (BE) Sapien/XT THV vs. a self-expanding (SE) THV. However, few data are available on the performance of a novel BE THV. PURPOSE: to compare early clinical performance and safety of the newly available BE Myval THV (Myval, Meril Life Sciences Pvt. Ltd., India) vs. the commonly used SE (Evolut R, Medtronic) THV.

methods A single-center, retrospective cohort analysis was performed with 166 consecutive patients undergoing TAVR from March 2019 to March 2021 for severe symptomatic AS treated with either the novel BE Myval or the SE Evolut R (ER) bioprosthesis. The primary endpoint was device success at day 30 according to the Valve Academic Research Consortium-3 (VARC-3). Secondary endpoints included 30-day all-cause mortality, cardiovascular mortality, more than mild PVL, permanent pacemaker implantation (PPI) rates and a composite of all-cause mortality and disabling stroke at 6 months.

results Among the 166 included patients, 108 patients received the SE ER THV and 58 patients were treated with the BE Myval THV. At baseline, the two groups showed comparable demographic characteristics. The primary composite endpoint of early device success occurred in 55 patients (94.8%) in the BE Myval group and in 90 patients (83.3%) in the SE ER group (OR 3.667, 95% CI 1.094-12.14;

conclusionsIn patients with severe symptomatic AS undergoing TAVR, the novel Myval BE THV provided a comparable performance to the well-known ER SE THV, and it was associated with a lower rate of PPI and ≥moderate PVL within 30 days and 6 months after the procedure. Randomized, head-to-head comparison trials are needed to confirm our results.

Indexed as

balloon-expandable Myval (BE Myval)paravalvular leak (PVL)permanent pacemaker implantation (PPI)self-expanding CoreValve Evolut R (SE ER)transcatheter aortic valve replacement (TAVR)

Identifiers

PMID35207232
PMCPMC8876233
OpenAlexW4213247662

What OpenQuestion holds

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Registered trials

None linked

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.