Observational studyBMJ open2021
Permanent pacemaker implantation after On-X surgical aortic valve replacement: SWEDEHEART observational study.
Observational study in BMJ open, 2021. 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, 3 citations in OpenAlex.
- Predictors of the Need for Permanent Pacemaker Implantation After Surgical Aortic Valve Replacement with a Biological Prosthesis and the Effect on Long-Term Survival.Journal of cardiovascular development and disease · 2024Article
- Fluid-structure interaction simulation of mechanical aortic valves: a narrative review exploring its role in total product life cycle.Frontiers in medical technology · 2024Review
Corrections and comments
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Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveBioprosthetic aortic valves with an extended subannular component, such as transcatheter valves, exert increased compression on the cardiac conduction system and increase the risk for permanent pacemaker implantation. It is unknown if the On-X mechanical prosthetic valve, which has an elongated subannular valve housing, increases the risk of permanent pacemaker implantation following aortic valve replacement.
designObservational nationwide cohort study.
settingSwedish population-based study.
participantsAll patients aged 18-65 years who underwent primary mechanical aortic valve replacement in Sweden between 2005 and 2018. We used the Swedish Web system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies register and other Swedish national health-data registers. EXPOSURE: Patients implanted with an On-X valve versus patients implanted with other bileaflet mechanical valves. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome measure was permanent pacemaker implantation within 30 days of surgery.
resultsA total of 2602 patients were included, and 581 patients received an On-X valve and 2021 patients received a St Jude Masters/Regent (n=945) or Carbomedics Reduced valve (n=1076). In the total study population, 115 (4.4%) permanent pacemaker implantations were performed within 30 days after aortic valve replacement. In the propensity score matched population, there was no significant difference in the rate of permanent pacemaker implantation in the On-X group compared with the control group: 3.6% (95% CI: 2.4% to 5.5%) vs 4.0% (95% CI: 2.7% to 5.9%), p=0.877.
conclusionsThe On-X prosthetic heart valve was associated with a similarly low risk for permanent pacemaker implantation after aortic valve replacement compared with other conventional bileaflet mechanical valves. The On-X elongated subannular valve housing does not interfere with the cardiac conduction system.
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Registered trials
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