Key result
Sutureless aortic valve replacement was associated with a higher rate of early permanent pacemaker implantation compared to stented valves (10.4% vs 3.1%), particularly with size XL valves.
Why the study?
Although sutureless aortic valves demonstrated non-inferiority to standard stented valves for major cardiovascular and cerebral events at 1 year, the factors correlating with permanent pacemaker implantation in both cohorts remained to be assessed.
Does sutureless aortic valve replacement increase the risk of permanent pacemaker implantation compared to stented sutured bioprosthesis in patients undergoing aortic valve replacement?
RCT (n=896)
Open-label
randomized
Does sutureless aortic valve replacement increase the risk of permanent pacemaker implantation compared to stented sutured bioprosthesis in patients undergoing aortic valve replacement?
Absolute Event Rate: 10.4% vs 3.1%
Sutureless aortic valve replacement is associated with a higher rate of early permanent pacemaker implantation compared to stented valves, particularly in patients receiving size XL valves or with preoperative conduction disorders.
Noninferiority supports Su-AVR consideration in selected patients; leaves open PPI predictors in this randomized cohort.
OBJECTIVES: Sutureless aortic valves demonstrated non-inferiority to standard stented valves for major cardiovascular and cerebral events at 1 year after aortic valve replacement. We aim to assess the factors correlating with permanent pacemaker implantation (PPI) in both cohorts. METHODS: PERSIST-AVR is a prospective, randomized, open-label trial. Patients undergoing aortic valve replacement were randomized to receive a sutureless aortic valve replacement (Su-AVR) or stented sutured bioprosthesis (SAVR). Multivariable analysis was performed to identify possible independent risk factors associated with PPI. A logistic regression analysis was performed to estimate the risk of PPI associated to different valve size. RESULTS: The 2 groups (Su-AVR; n = 450, SAVR n = 446) were well balanced in terms of preoperative risk factors. Early PPI rates were 10.4% in the Su-AVR group and 3.1% in the SAVR. PPI prevalence correlated with valve size XL (P = 0.0119) and preoperative conduction disturbances (P = 0.0079) in the Su-AVR group. No predictors were found in the SAVR cohort. Logistic regression analysis showed a significantly higher risk for PPI with size XL compared to each individual sutureless valve sizes [odds ratio (OR) 0.272 vs size S (95%confidence interval 0.07-0.95), 0.334 vs size M (95% CI 0,16-0; 68), 0.408 vs size L (95% CI 0,21-0.81)] but equivalent risk of PPI rates for all other combination of valve sizes. CONCLUSIONS: Su-AVR is associated with higher PPI rate as compared to SAVR. However, the increased PPI rate appears to be size-dependent with significant higher rate only for size XL. The combination of preoperative conduction disorder and a size XL can lead to a higher probability of early PPI in Su-AVR. CLINICAL TRIAL REGISTRATION NUMBER: NCT02673697.
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Lorusso et al. (2022) conducted an RCT in Aortic valve replacement (n=896). Sutureless aortic valve replacement (Su-AVR) vs. Stented sutured bioprosthesis (SAVR) was evaluated on Early permanent pacemaker implantation (PPI). Sutureless aortic valve replacement was associated with a higher rate of early permanent pacemaker implantation compared to stented valves (10.4% vs 3.1%), particularly with size XL valves.
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