Evidence map›Paper›PMID 40063121›Full record

ArticleClinical research in cardiology : official journal of the German Cardiac Society2025

Transcatheter aortic valve replacement in heavily calcified aortic valve stenosis: a multicenter comparison.

M Saad, H Seoudy, K Bramlage, P Bramlage, J C Voran, T Puehler, G Lutter, A Allali, M Landt, J Frank and 9 more

Abstract readMulticenter StudyComparative Study
In one paragraph

Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–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

5 citing papers in PubMed.

  1. Article
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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

19 authors.

M SaadDepartment of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Arnold-Heller-Str.3, Haus K3, 24105, Kiel, Germany. mohammed.saad@uksh.de.ORCID http://orcid.org/0000-0002-8680-3706
H SeoudyDepartment of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Arnold-Heller-Str.3, Haus K3, 24105, Kiel, Germany.
K BramlageInstitute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
P BramlageInstitute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
J C VoranDepartment of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Arnold-Heller-Str.3, Haus K3, 24105, Kiel, Germany.
T PuehlerDZHK (German Center for Cardiovascular Research), partner site Hamburg/Kiel/Lübeck, Kiel, Germany.
G LutterDZHK (German Center for Cardiovascular Research), partner site Hamburg/Kiel/Lübeck, Kiel, Germany.
A AllaliDepartment of Cardiac and Vascular Surgery, University Clinical Center Schleswig-Holstein (UKSH), Kiel, Germany.
M LandtHeart Center Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany.
J FrankDepartment of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Arnold-Heller-Str.3, Haus K3, 24105, Kiel, Germany.
O BishtDepartment of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Arnold-Heller-Str.3, Haus K3, 24105, Kiel, Germany.
M SalemDepartment of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Arnold-Heller-Str.3, Haus K3, 24105, Kiel, Germany.
H WienemannKlinik III für Innere Medizin-Kardiologie, Herzzentrum der Universität Köln, Kerpener Str. 62, 50937, Köln, Germany.
M AdamKlinik III für Innere Medizin-Kardiologie, Herzzentrum der Universität Köln, Kerpener Str. 62, 50937, Köln, Germany.
T ZeusKlinik für Kardiologie, Pneumologie & Angiologie, Universitätsklinikum Düsseldorf, 40225, Düsseldorf, Germany.
V VeulemansKlinik für Kardiologie, Pneumologie & Angiologie, Universitätsklinikum Düsseldorf, 40225, Düsseldorf, Germany.
S BleizifferClinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW, 32545, Bad Oeynhausen, Germany.
T K RudolphClinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW, 32545, Bad Oeynhausen, Germany.
D FrankDepartment of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Arnold-Heller-Str.3, Haus K3, 24105, Kiel, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHeavy calcifications in severe aortic stenosis (AS) pose a major challenge in patients undergoing transcatheter aortic valve replacement (TAVR). Only a few studies have addressed the performance of different transcatheter heart valves (THV) in this subgroup of patients.

objectivesWe aimed to investigate the outcomes of the self-expanding Medtronic CoreValve Evolut valve frame and the balloon-expandable Edwards SAPIEN-3/3 Ultra THV in this challenging patient population. MATERIALS AND

methodsThis was a multicenter registry including a total of 1513 patients with heavily calcified AS undergoing TAVR. The primary endpoint was the incidence and degree of paravalvular leak (PVL) after TAVR. Secondary endpoints were post-implant hemodynamics as well as clinical endpoints according to the VARC-3 definitions.

resultsThe CoreValve Evolut R but not the Evolut PRO showed significantly higher rates of PVL compared to the SAPIEN-3/3 Ultra (44.8% vs. 29.5% for mild PVL, p < 0.001), while there was no significant difference in ≥ moderate PVL between both groups (p = 0.399). The CoreValve Evolut R and Evolut PRO showed superior THV hemodynamics compared to the SAPIEN-3/3 Ultra group. These findings were confirmed in a propensity score-matched analysis. There were no significant differences regarding short-term outcomes including permanent pacemaker implantation and all-cause mortality between the three groups.

conclusionIn patients with severely calcified AS, both CoreValve Evolut PRO and SAPIEN-3/3 Ultra THV showed lower rates of PVL than the CoreValve Evolut R. The self-expanding CoreValve platform had superior post-implant hemodynamics than the SAPIEN-3/3 Ultra system.

Indexed as

Aortic ValveAortic Valve StenosisCalcinosisHeart Valve ProsthesisRegistriesTranscatheter Aortic Valve ReplacementAgedAged, 80 and overFemaleFollow-Up StudiesHemodynamicsHumansIncidenceMaleProsthesis DesignRetrospective StudiesAortic valve stenosisCalcificationParavalvular leakTranscatheter aortic valve replacement

Identifiers

PMID40063121
PMCPMC11913988

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Registered trials

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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.