Hemodynamic Performance of Sutureless vs. Conventional Bioprostheses for Aortic Valve Replacement: The 1-Year Core-Lab Results of the Randomized PERSIST-AVR Trial

Abstract

ObjectiveSutureless aortic valves are an effective option for aortic valve replacement (AVR) showing non-inferiority to standard stented aortic valves for major cardiovascular and cerebral events at 1-year. We report the 1-year hemodynamic performance of the sutureless prostheses compared with standard aortic valves, assessed by a dedicated echocardiographic core lab.MethodsPerceval Sutureless Implant vs. Standard Aortic Valve Replacement (PERSIST-AVR) is a prospective, randomized, adaptive, open-label trial. Patients undergoing AVR, as an isolated or combined procedure, were randomized to receive a sutureless [sutureless aortic valve replacement (Su-AVR)] (n = 407) or a stented sutured [surgical AVR (SAVR)] (n = 412) bioprostheses. Site-reported echocardiographic examinations were collected at 1 year. In addition, a subgroup of the trial population (Su-AVR n = 71, SAVR = 82) had a complete echocardiographic examination independently assessed by a Core Lab (MedStar Health Research Institute, Washington D.C., USA) for the evaluation of the hemodynamic performance.ResultsThe site-reported hemodynamic data of stented valves and sutureless valves are stable and comparable during follow-up, showing stable reduction of mean and peak pressure gradients through one-year follow-up (mean: 12.1 ± 6.2 vs. 11.5 ± 4.6 mmHg; peak: 21.3 ± 11.4 vs. 22.0 ± 8.9 mmHg). These results at 1-year are confirmed in the subgroup by the core-lab assessed echocardiogram with an average mean and peak gradient of 12.8 ± 5.7 and 21.5 ± 9.1 mmHg for Su-AVR, and 13.4 ± 7.7 and 23.0 ± 13.0 mmHg for SAVR. The valve effective orifice area was 1.3 ± 0.4 and 1.4 ± 0.4 cm2 at 1-year for Su-AVR and SAVR. These improvements are observed across all valve sizes. At 1-year evaluation, 91.3% (n = 42) of patients in Su-AVR and 82.3% in SAVR (n = 51) groups were free from paravalvular leak (PVL). The rate of mild PVL was 4.3% (n = 2) in Su-AVR and 12.9% (n = 8) in the SAVR group. A similar trend is observed for central leak occurrence in both core-lab assessed echo groups.ConclusionAt 1-year of follow-up of a PERSIST-AVR patient sub-group, the study showed comparable hemodynamic performance in the sutureless and the stented-valve groups, confirmed by independent echo core lab. Perceval sutureless prosthesis provides optimal sealing at the annulus with equivalent PVL and central regurgitation extent rates compared to sutured valves. Sutureless valves are therefore a reliable and essential technology within the modern therapeutic possibilities to treat aortic valve disease.

Conventional Prostheses versus Sutureless Perceval for Aortic Valve Replacement: A Meta-Analysis

“…[9][10][11][12] However, whether sutureless valves are more advantageous than the conventional sutured prostheses for AVR is unclear. 7,[12][13][14][15][16][17][18] Therefore, this meta-analysis compared sutureless Perceval prostheses versus conventional sutured valves for AVR. The primary outcomes of interest were to compare the intraoperative variables (ACC and CPB times), valve's hemodynamic performance (postoperative peak and mean transvalvular pressure gradients, mean aortic valve area), length of stay (intensive care unit [ICU] and hospital stay), and the rate of postoperative pacemaker implantation and early mortality between the valves.…”

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

“… 20 A subanalysis of the Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement (PERSIST-AVR) trial reported significantly reduced rates of major adverse cardiac and cerebrovascular events (MACCE), stroke, atrial fibrillation, and rehospitalization following SUAVR via ministernotomy as compared with conventional sutured AVR. 21 However, this did come at the expense of an increased permanent pacemaker implantation (PPI) rate. 22 Retrospective analysis of patients undergoing SUAVR via full sternotomy versus ministernotomy indicates equivalent intraoperative time parameters, reduced hospital and intensive care unit (ICU) length of stay (LOS), as well as reduced left ventricular diastolic volume with ministernotomy.…”

“…The was no significant difference in the rate of overall PVL for SUAVR and SAVR, respectively (11.3% vs 15.0%, P = 0.315). 21 In a subanalysis of the PERSIST-AVR trial comparing ministernotomy and full sternotomy approaches, SUAVR resulted in significantly lower MACCE (5.2% vs 10.8%), stroke (1.0% vs 5.4%), atrial fibrillation (4.2% vs 11.4%), and rehospitalization (21.8 vs 47.6 days) compared with SAVR when performed via ministernotomy; however, for SUAVR, this came at the expense of a higher PPI rate (11% vs 1.6%). 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.…”

The Sutureless Biological Bentall Procedure: A New Technique to Create a Modular Valve-Conduit Construct

“…Perceval sutureless AVRs have been effectively used in the treatment of aortic stenosis. [23][24][25][26] The use of Perceval sutureless AVR for aortic valve insufficiency does have inherent concerns for possible issues with valve migration, related to the absence of a calcified aortic annulus. 29 The prosthetic valve has been used successfully with modifications to the implant technique and careful assessment of the aortic root anatomy.…”

“…5,22 The Perceval sutureless valve (Corcym, Saluggia, Italy) for AVR offers the benefit of short aortic clamp time, excellent hemodynamics, and very low rate of paravalvular leak. 23,24 This is attributed to the complete decalcification of the valve in combination with the nitinol-based frame that secures the device at the annular level. The benefits of the sutureless AVR have not previously been expanded to the biological Bentall (BioBentall) modular construct.…”