Trial reportClinical research in cardiology : official journal of the German Cardiac Society2008
Eight-year follow-up after prospectively randomized implantation of different mechanical aortic valves.
Trial report in Clinical research in cardiology : official journal of the German Cardiac Society, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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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.
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.
Who cites it
2 citing papers in PubMed.
- Comparative Long-Term Clinical Performance of Mechanical Aortic Valve Prostheses.JAMA network open · 2024Article
- Ruptured pulmonary artery caused by isolated pulmonary valve endocarditis: case report.Clinical research in cardiology : official journal of the German Cardiac Society · 2010Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe aim of this prospectively randomized study was to evaluate the hemodynamic and functional outcomes after aortic valve replacement with three different bileaflet mechanical valves.
methodsFrom March 1996 to August 1998, 300 consecutive patients were randomly assigned to receive ATS (n = 100), Carbomedics (n = 100), or St Jude Medical Hemodynamic Plus (n = 100) mechanical aortic valve replacement. There were no significant differences regarding patient age (61 +/- 8 years), gender, NYHA, aortic valve pathology, ventricular morphology, ejection fraction and requirement for additional procedures at implant. Mean follow-up extends to 95 +/- 21 months at a total of 2,891 patients years and is in 95.3% complete.
resultsImplanted valve sizes were comparable at 24 +/- 2 mm (ATS), 23.7 +/- 1.6 mm (CM), and 23.6 +/- 1.9 mm (SJMHP) (NS). Follow-up results were: transvalvular flow velocities 2.3/2.3/2.2 m/s, ejection fraction 64/59/63%, trivial transvalvular incompetence 3/3/2; paravalvular leak 2/3/2; freedom of reoperation 100/99/99%, NYHA functional status 1.5/1.8/1.6, overall survival 86.4/82.8/80.6%, freedom from thrombembolic events 100/96/98%, freedom from hemorrhage 100/100/99%, freedom from all valve related events was 100/96/98%; respectively (NS). There were no episodes of endocarditis. Ninety-four percent of the patients were satisfied with the procedure enjoying an enhanced daily life activity.
conclusionsThere are no clinically relevant differences among the tested bileaflet aortic valves. Regardless of valve type, there was a rather low complication rate in this relatively young population. All three bileaflet prostheses are well suited for aortic valve replacement.
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Registered trials
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