Permanent pacemaker implantation after On-X surgical aortic valve replacement: SWEDEHEART observational study

OBJECTIVE: Bioprosthetic 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. DESIGN: Observational nationwide cohort study. SETTING: Swedish population-based study. PARTICIPANTS: All 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. RESULTS: A 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. CONCLUSIONS: The 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.