Evidence map›Paper›PMID 34546428›Full record

ArticleClinical research in cardiology : official journal of the German Cardiac Society2021

In-hospital outcomes of self-expanding and balloon-expandable transcatheter heart valves in Germany.

Peter Stachon, Philip Hehn, Dennis Wolf, Timo Heidt, Vera Oettinger, Manfred Zehender, Christoph Bode, Constantin von Zur Mühlen, Klaus Kaier

Abstract read
In one paragraph

Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. COVID-19 pandemic affects STEMI numbers and in-hospital mortality: results of a nationwide analysis in Germany.Clinical research in cardiology : official journal of the German Cardiac Society · 2023
    Article
  7. Article
  8. Article
  9. 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

9 authors.

Peter StachonDepartment of Cardiology and Angiology I, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
Philip HehnInstitute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Stefan-Meier-Str. 26, 79104, Freiburg, Germany.
Dennis WolfDepartment of Cardiology and Angiology I, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
Timo HeidtDepartment of Cardiology and Angiology I, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
Vera OettingerDepartment of Cardiology and Angiology I, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
Manfred ZehenderDepartment of Cardiology and Angiology I, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
Christoph BodeDepartment of Cardiology and Angiology I, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
Constantin von Zur Mühlen *Department of Cardiology and Angiology I, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
Klaus Kaier *Center of Big Data Analysis in Cardiology (CeBAC), Heart Center Freiburg University, Freiburg, Germany. kaier@imbi.uni-freiburg.de.ORCID http://orcid.org/0000-0003-0837-6945

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe effect of valve type on outcomes in transfemoral transcatheter aortic valve replacement (TF-TAVR) has recently been subject of debate. We investigate outcomes of patients treated with balloon-expanding (BE) vs. self-expanding (SE) valves in in a cohort of all these procedures performed in Germany in 2018.

methodsAll patients receiving TF-TAVR with either BE (N = 9,882) or SE (N = 7,413) valves in Germany in 2018 were identified. In-hospital outcomes were analyzed for the endpoints in-hospital mortality, major bleeding, stroke, acute kidney injury, postoperative delirium, permanent pacemaker implantation, mechanical ventilation > 48 h, length of hospital stay, and reimbursement. Since patients were not randomized to the two treatment options, logistic or linear regression models were used with 22 baseline patient characteristics and center-specific variables as potential confounders. As a sensitivity analysis, the same confounding factors were taken into account using the propensity score methods (inverse probability of treatment weighting).

resultsBaseline characteristics differed substantially, with higher EuroSCORE (p < 0.001), age (p < 0.001) and rate of female sex (p < 0.001) in SE treated patients. After risk adjustment, no marked differences in outcomes were found for in-hospital mortality [risk adjusted odds ratio (aOR) for SE instead of BE 0.94 (96% CI 0.76;1.17), p = 0.617] major bleeding [aOR 0.91 (0.73;1.14), p = 0.400], stroke [aOR 1.13 (0.88;1.46), p = 0.347], acute kidney injury [OR 0.97 (0.85;1.10), p = 0.621], postoperative delirium [aOR 1.09 (0.96;1.24), p = 0.184], mechanical ventilation > 48 h [aOR 0.98 (0.77;1.25), p = 0.893], length of hospital stay (risk adjusted difference in days of hospitalization (SE instead of BE): - 0.05 [- 0.34;0.25], p = 0.762) and reimbursement [risk adjusted difference in reimbursement (SE instead of BE): - €72 (- €291;€147), p = 0.519)] There is, however, an increased risk of PPI for SE valves (aOR 1.27 [1.15;1.41], p < 0.001). Similar results were found after application of propensity score adjustment.

conclusionsWe find broadly equivalent outcomes in contemporary TF-TAVR procedures, regardless of the valve type used. Incidence of major complications is very low for both types of valve.

Indexed as

Heart Valve ProsthesisInpatientsPropensity ScoreAged, 80 and overAortic ValveAortic Valve StenosisFemaleFollow-Up StudiesGermanyHospital MortalityHumansIncidenceMalePostoperative ComplicationsProsthesis DesignRetrospective StudiesAortic stenosisInterventional cardiologyMechanismTranscatheter aortic valve replacementValve expansion

Identifiers

PMID34546428
PMCPMC8639556

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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.