Evidence map›Paper›PMID 40627314›Full record

Observational studyCardiovascular intervention and therapeutics2025

Five-year outcomes after surgical versus transcatheter aortic valve replacement with new generation devices from the prospective OBSERVANT studies.

Stefano Rosato, Fausto Biancari, Marco Barbanti, Giuseppe Tarantini, Marco Ranucci, Giuliano Costa, Timo Mäkikallio, Gian Paolo Ussia, Giovanni Baglio, Mahin Tatari and 3 more

Abstract readObservational StudyMulticenter Study
PubMed Publisher
In one paragraph

Observational study in Cardiovascular intervention and therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

13 authors.

Stefano RosatoNational Centre for Global Health, Istituto Superiore Di Sanità, Via Giano Della Bella 34, 00161, Rome, Italy. stefano.rosato@iss.it.ORCID http://orcid.org/0000-0002-6690-5537
Fausto BiancariDepartment of Cardiovascular Surgery, Centro Cardiologico Monzino IRCCS, Milan, Italy.
Marco BarbantiUniversità Degli Studi Di Enna "Kore", Enna, Italy.
Giuseppe TarantiniDivision of Cardiology, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padua, Italy.
Marco RanucciDepartment of Cardiothoracic and Vascular Anesthesia and ICU, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.
Giuliano CostaUniversità Degli Studi Di Enna "Kore", Enna, Italy.
Timo MäkikallioDepartment of Medicine, South Karelia Central Hospital, University of Helsinki, Lappeenranta, Finland.
Gian Paolo UssiaDepartment of Interventional Cardiology, Campus Bio-Medico University of Rome, Rome, Italy.
Giovanni BaglioItalian National Agency for Regional Healthcare Services, Rome, Italy.
Mahin TatariNational Centre for Global Health, Istituto Superiore Di Sanità, Via Giano Della Bella 34, 00161, Rome, Italy.
Gabriella BadoniNational Centre for Global Health, Istituto Superiore Di Sanità, Via Giano Della Bella 34, 00161, Rome, Italy.
Paola D'ErrigoNational Centre for Global Health, Istituto Superiore Di Sanità, Via Giano Della Bella 34, 00161, Rome, Italy.
OBSERVANT I. I. Research Group

Funding

Ministero della Salute 1M30Ministero della Salute PE-2016-02364619
6 · The paper itself

Abstract

The efficacy and durability of transcatheter (TAVR) over surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS) has been demonstrated in randomized studies, but these findings were not confirmed in several observational studies. This is an analysis of 5706 AS patients who underwent SAVR from 2010 and 2012, and 2989 AS patients who underwent TAVR from 2017 and 2018 from the prospective OBSERVANT I and II studies. TAVR procedures were performed with new-generation devices. Five-year all-cause mortality was the primary outcome of this analysis. Propensity score matching yielded 1008 pairs of TAVR and SAVR patients. The mean EuroSCORE II was comparable between the study cohorts (TAVR 4.7 ± 4.0% and SAVR 4.5 ± 5.7%, p = 0.419). At 5 years, TAVR was associated with higher mortality (44.4% vs. 33.2%, HR 1.36, 95%CI 1.18-1.57, Log-rank test p < 0.001), major adverse cardiac and cerebrovascular events (MACCEs) (49.3% vs. 37.9%, HR 1.32, 95%CI 1.15-1.51, Log-rank test p < 0.001), permanent pacemaker implantation (23.1% vs. 9.3%, HR 2.72, 95%CI 2.14-3.45, Log-rank test p < 0.001) and percutaneous coronary intervention rates (3.7% vs. 1.2%, HR 3.44, 95%CI 1.76-6.71, Log-rank test p < 0.001) compared to SAVR. Age ≤ 80 years, male gender, EuroSCORE II ≤ 4.0%, absence of coronary artery disease and absence of diabetes were associated with higher 5-year mortality after TAVR compared to SAVR. TAVR had a significantly higher 5-year mortality than SAVR both in patients with left ventricular ejection fraction ≤ 50% and > 50%. This observational study from prospective data showed that TAVR using new-generation devices was associated with increased rates of all-cause mortality compared to SAVR at 5 years. These findings should be viewed considering the non-randomized nature of this study and may be attributable to the characteristics of patients selected for TAVR, rather than the procedure itself.

Indexed as

Aortic ValveAortic Valve StenosisHeart Valve ProsthesisHeart Valve Prosthesis ImplantationTranscatheter Aortic Valve ReplacementAgedAged, 80 and overFemaleHumansMalePostoperative ComplicationsPropensity ScoreProspective StudiesTime FactorsTreatment OutcomeSAVRTAVRTranscatheter aortic valve implantationTranscatheter aortic valve replacement

Identifiers

PMID40627314

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.