Evidence map›Paper›PMID 38321820›Full record

Trial reportEuropean heart journal2024

Transcatheter or surgical aortic valve implantation: 10-year outcomes of the NOTION trial.

Hans Gustav Hørsted Thyregod, Troels Højsgaard Jørgensen, Nikolaj Ihlemann, Daniel Andreas Steinbrüchel, Henrik Nissen, Bo Juel Kjeldsen, Petur Petursson, Ole De Backer, Peter Skov Olsen, Lars Søndergaard

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European heart journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 182 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
182citing papers in PubMed, 5 pooled it
117.0field-weighted citation impact, top 1% 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

182 citing papers in PubMed, 5 syntheses or guidelines pooled it, 291 citations in OpenAlex.

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122 more citing papers are in PubMed but not listed here.

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

10 authors at 4 institutions in 2 countries.

Hans Gustav Hørsted ThyregodDepartment of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.ORCID 0000-0002-9385-8318
Troels Højsgaard JørgensenDepartment of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.
Nikolaj IhlemannDepartment of Cardiology, Bispebjerg University Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, Denmark.
Daniel Andreas SteinbrüchelDepartment of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.
Henrik NissenDepartment of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense, Denmark.ORCID 0000-0002-0842-3644
Bo Juel KjeldsenDepartment of Cardiothoracic and Vascular Surgery, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense, Denmark.
Petur PeturssonDepartment of Cardiology, Sahlgrenska University Hospital, Blå Stråket 5, 413 45 Gothenburg, Sweden.
Ole De BackerDepartment of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.
Peter Skov OlsenDepartment of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.
Lars SøndergaardDepartment of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.
Copenhagen University Hospital · DKOdense University Hospital · DKBispebjerg Hospital · DKSahlgrenska University Hospital · SE

Funding

MITRAL VALVE REPLACEMENT IN PATIENTS WITH IHSSZ01HL002733 · NHLBI · HEART, LUNG, AND BLOOD INSTITUTE · PI MCINTOSH, C L · 1985 to 1988
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Danish Heart Foundation 09-10-AR76-A2733-25400
6 · The paper itself

Abstract

BACKGROUND AND

aimsTranscatheter aortic valve implantation (TAVI) has become a viable treatment option for patients with severe aortic valve stenosis across a broad range of surgical risk. The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize patients at lower surgical risk to TAVI or surgical aortic valve replacement (SAVR). The aim of the present study was to report clinical and bioprosthesis outcomes after 10 years.

methodsThe NOTION trial randomized 280 patients to TAVI with the self-expanding CoreValve (Medtronic Inc.) bioprosthesis (n = 145) or SAVR with a bioprosthesis (n = 135). The primary composite outcome was the risk of all-cause mortality, stroke, or myocardial infarction. Bioprosthetic valve dysfunction (BVD) was classified as structural valve deterioration (SVD), non-structural valve dysfunction (NSVD), clinical valve thrombosis, or endocarditis according to Valve Academic Research Consortium-3 criteria. Severe SVD was defined as (i) a transprosthetic gradient of 30 mmHg or more and an increase in transprosthetic gradient of 20 mmHg or more or (ii) severe new intraprosthetic regurgitation. Bioprosthetic valve failure (BVF) was defined as the composite rate of death from a valve-related cause or an unexplained death following the diagnosis of BVD, aortic valve re-intervention, or severe SVD.

resultsBaseline characteristics were similar between TAVI and SAVR: age 79.2 ± 4.9 years and 79.0 ± 4.7 years (P = .7), male 52.6% and 53.8% (P = .8), and Society of Thoracic Surgeons score < 4% of 83.4% and 80.0% (P = .5), respectively. After 10 years, the risk of the composite outcome all-cause mortality, stroke, or myocardial infarction was 65.5% after TAVI and 65.5% after SAVR [hazard ratio (HR) 1.0; 95% confidence interval (CI) 0.7-1.3; P = .9], with no difference for each individual outcome. Severe SVD had occurred in 1.5% and 10.0% (HR 0.2; 95% CI 0.04-0.7; P = .02) after TAVI and SAVR, respectively. The cumulative incidence for severe NSVD was 20.5% and 43.0% (P < .001) and for endocarditis 7.2% and 7.4% (P = 1.0) after TAVI and SAVR, respectively. No patients had clinical valve thrombosis. Bioprosthetic valve failure occurred in 9.7% of TAVI and 13.8% of SAVR patients (HR 0.7; 95% CI 0.4-1.5; P = .4).

conclusionsIn patients with severe AS and lower surgical risk randomized to TAVI or SAVR, the risk of major clinical outcomes was not different 10 years after treatment. The risk of severe bioprosthesis SVD was lower after TAVR compared with SAVR, while the risk of BVF was similar.

Indexed as

Aortic Valve StenosisEndocarditisHeart Valve ProsthesisHeart Valve Prosthesis ImplantationMyocardial InfarctionStrokeThrombosisTranscatheter Aortic Valve ReplacementAgedAged, 80 and overAortic ValveHumansMaleRisk FactorsTreatment OutcomeAortic valve stenosisBioprosthetic aortic valve durabilitySurgical aortic valve replacementTranscatheter aortic valve implantationTranscatheter aortic valve replacement

Identifiers

PMID38321820
PMCPMC10984572
OpenAlexW4391592298

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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.