Rapid Deployment Aortic Valve Replacement with the Perceval S and Intuity Elite

Abstract

Background Rapid deployment aortic valve replacement (RDAVR) has emerged as an alternative to conventional aortic valve replacement. This single-center study retrospectively analyzed clinical outcomes and hemodynamic performance of the Perceval S (LivaNova) and Intuity Elite (Edwards LifeSciences) rapid deployment valves (RDVs) in a propensity score matched patient cohort. Methods A total of 372 consecutive patients with symptomatic aortic valve stenosis underwent RDAVR between 2012 and 2018 at our institution. The Intuity Elite (INT group) and Perceval S (PER group) were implanted in 251 and 121 patients, respectively. After 1:1 propensity score matching for relevant preoperative comorbidities, 107 patient pairs were compared with respect to relevant perioperative data including hemodynamic parameter, postoperative pacemaker implantation, and 30-day all-cause mortality. Results Propensity score matching resulted in balanced characteristics between groups. Cardiopulmonary bypass and aortic cross-clamp time did not differ between groups, but more patients in the INT group received coronary artery bypass grafting compared with the PER group (56 vs. 42%; p = 0.055). Thirty-day mortality (4.7 vs. 2.2%) and need for permanent pacemaker implantation (7 versus 4.4%) were comparable between the INT and PER groups for isolated AVR and also for combined procedures, respectively. Cerebrovascular events showed comparable low rates for both RDVs (INT group [1.9%] vs. PER group [2.8%]). Indexed effective orifice area was higher in the INT group (0.90 vs. 0.82 cm2/m2) and coupled to a lower peak (17 ± 7 vs. 22 ± 8) and mean (10 ± 5 vs. 12 ± 4) pressure gradients compared with the PER group. Conclusions Our propensity score analysis in AVR patients showed good hemodynamic characteristics with comparable 30-day mortality rate and complications rates for both investigated RDVs.

Comparison of Self-Expanding RDV Perceval S versus TAVI ACURATE neo/TF

“…Numbers of PPM after PER also differ between several studies and, as mentioned, the expertise and learning curve of the distinct center or surgeon, and whether postballooning is performed, has to be kept in mind and has impact on the displayed outcomes. Our study group has shown superior rates of PPM of 4.4% after isolated PER implantation in a larger study cohort, comparing two RDVs, 29 and further studies have shown rates of PPM for PER ranging from 5.7% in the GARY to 10% or higher. 16,19,30 Subgroup analysis of patients who received a new pacemaker after RDAVR did not show link to the size of the prosthesis.…”

Sutureless vs. rapid-deployment valve: a systemic review and meta-analysis for a direct comparison of intraoperative performance and clinical outcomes

“…All studies covered 3,526 patients (sutureless group = 1,772 and rapid-deployment group = 1,754). Among these studies, propensity score matching was used in five studies ( 11 , 17 , 20 , 24 , 25 ), whereas in one study, the multivariable analysis method was used for determining early mortality in risk factor analysis ( Table 1 ) ( 21 ). A larger proportion of male patients were enrolled in the rapid-deployment group.…”

Pearls, pitfalls, and surgical indications of the Intuity TM heart valve: A rapid deployment bioprosthesis. A systematic review of the literature

“…Long‐term cardiac mortality ranged from 0.9% to 1.55% for Intuity (Elite Edwards) and 1.4%−3.3% for the Perceval (CORCYM) valve (Supporting Information: Table ) 23–28 . The incidence of complications identified PVL (Intuity 0.24%−0.7% and Perceval 0%−1%), endocarditis (Intuity 0.2%−0.7% and Perceval 1.6%−6.6%), stroke (Intuity 0.36%−1.4% and Perceval 0%−0.8%), MI (Intuity 0.07%−0.26%), and SVD (Intuity 0.12%−0.7% and Perceval 0%) (Supporting Information: Table) 18,20,29–33 . Compared to SFS, MINV mortality ranged from 0% to 4.3% for MINV and 0%−2.1% for SFS (Supporting Information: Table ) 1,34,35 .…”

“…[23][24][25][26][27][28] The incidence of complications identified PVL (Intuity 0.24%−0.7% and Perceval 0%−1%), endocarditis (Intuity 0.2%−0.7% and Perceval 1.6%−6.6%), stroke (Intuity 0.36%−1.4% and Perceval 0%−0.8%), MI (Intuity 0.07%−0.26%), and SVD (Intuity 0.12%− 0.7% and Perceval 0%) (Supporting Information: Table3). 18,20,[29][30][31][32][33] Compared to SFS, MINV mortality ranged from 0% to 4.3% for MINV F I G U R E 1 Flowchart of studies inclusion and exclusion criteria and sutureless valve indications compared to other devices and 0%−2.1% for SFS (Supporting Information: Table 4). 1,34,35 The incidence of PVL (MINV 0%−1.3% vs. SFS 0%), MI (MINV 0% vs. SFS 2.1%), PPI (MINV 2.3%−5.6% vs. SFS 0%), endocarditis (MINV 0% vs. SFS 0%), and reoperation (MINV 0%−2.2% vs. SFS 0%−2.1%) are specified in parenthesis.…”