Pacemaker implantation after sutureless or stented valve: results from a controlled randomized trial

Abstract

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.

Early outcomes of aortic valve replacement with Perceval PLUS sutureless valve: results of the prospective multicentric MANTRA study

“…The results showed a decreased pacemaker rate and improved hemodynamics, confirming the importance of avoiding oversizing, which is crucial for the best hemodynamic and clinical outcomes with the Perceval valve. This is also in line with the lowest incidence of permanent pacemaker implantation observed in this series compared to other published experiences [11,23]. The reason behind this positive trend may be related to the improved design of Perceval PLUS, featuring a reduced sub annular valve collar protrusion in the size XL.…”

“…The reason behind this positive trend may be related to the improved design of Perceval PLUS, featuring a reduced sub annular valve collar protrusion in the size XL. While in the previous publications with Perceval the use of a valve size XL was an independent predictor of postoperative permanent pacemaker implant [23], in this preliminary experience the incidence of PPI with valve size XL was comparable to other valve sizes (4.5% size XL vs 4.6%, 5.1% and 2.0% with size S, M and L, respectively), suggesting the positive impact of the new design on this size.…”

The Perceval Sutureless Bioprosthetic Aortic Valve: Evolution of Surgical Valve Technology

“… 22 An additional subanalysis of this trial by Lorusso et al analyzed the influence of prosthesis size on PPI rates and determined that increased rates of PPI following SUAVR came only with implantation of the extra-large device. 88 The results of multiple large retrospective, propensity-matched analyses are largely consistent with these results. 89 , 90 Superior results in various measures of postoperative morbidity, including bleeding, ICU and hospital LOS, low cardiac output syndrome, atrial fibrillation, and mild aortic regurgitation have also been noted following SUAVR.…”

Predictors of New and Persistent New Left Bundle Branch Block One Year after the Implantation of a Sutureless and Rapid-Deployment Aortic Valve Prosthesis

“…Also, the technique of valve deployment during TAVI is related to the frequency of PPI and was found to be greater in the group of early-generation self-expanding compared to balloon-expandable valves [ 5 ]. It has been demonstrated that the implantation of a sutureless/rapid-deployment (SURD) aortic valve prosthesis is related to higher PPI rate in comparison to a stent-sutured bioprosthesis (SAVR) [ 6 ]. Furthermore, the frequency of intraventricular conduction abnormalities, such as left (LBBB) and right bundle branch blocks (RBBB), is increased with prosthetic aortic valve implantation.…”