Direct Comparison of the Edwards Intuity Elite and Sorin Perceval S Rapid Deployment Aortic Valves

Liakopoulos, Oliver J.; Gerfer, Stephen; Weider, S.; Rahmanian, Parwis B.; Zeriouh, Mohamed; Eghbalzadeh, Kaveh; Sabashnikov, Anton; Choi, Yeong‐Hoon; Wippermann, Jens; Wahlers, Thorsten

doi:10.1016/j.athoracsur.2017.06.034

Cited by 38 publications

(44 citation statements)

References 20 publications

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“…Despite our high-risk patient profile with a mean age of approximately 75 years and with more than 60% of patients requiring combined surgical procedures, the overall 30-day all-cause mortality and postoperative complication rates for both RDVs were acceptable and close to the estimated EuroSCORE. As previously reported by our group, 15 minimally invasive AVR was more often performed with the Perceval S when compared with the Intuity Elite RDV in our unmatched cohorts. Conversely, the Intuity Elite was more often used when concomitant CABG was required, as it offers the distinct advantage of a lower aortotomy compared with the Perceval S, which does not technically interfere with the proximal graft anastomoses.…”

Section: Discussionsupporting

confidence: 81%

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

Liakopoulos

Gerfer

Rahmanian

et al. 2020

Thorac Cardiovasc Surg

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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.

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Section: Discussionsupporting

confidence: 81%

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

Liakopoulos

Gerfer

Rahmanian

et al. 2020

Thorac Cardiovasc Surg

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“…After full review, seven papers met the pre-determined inclusion criteria (4,5,8-12) ( Figure S2) Table 2). Overall, all-cause mortality was reported in 3,998 patients (2,351 SURD, 1,647 RDV) across all seven studies (4,5,(8)(9)(10)(11)(12). In the overall studied population, there were 95 deaths (2.4%) with 54 deaths (2.3%) in the SURD group and 41 deaths (2.5%) in the RDV group.…”

Section: Resultsmentioning

confidence: 94%

“…If this study is excluded, CPB times remain shorter for patients receiving SURD by 8.8 minutes (95% CI: 6.0-11.7; P<0.001; I 2 =23%). ICU LOS was reported in 3,165 patients (2,077 SURD, 1,088 RDV) across six studies (5,(8)(9)(10)(11)(12). There was a trend towards a shorter ICU LOS with SURD, although this did not reach statistical significance (95% CI: 2.26-0.01; P=0.05; I 2 =84%) ( Figure S14).…”

Section: Resultsmentioning

confidence: 99%

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Sutureless valve and rapid deployment valves: a systematic review and meta-analysis of comparative studies

Flynn

Williams

Chakos

et al. 2020

Ann Cardiothorac Surg

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Background: The treatment of aortic valve disease is the most common valvular surgery in industrialized nations, with 3-9% of the population over the age of eighty having at least moderate aortic stenosis. As transcatheter aortic valve replacement (TAVR) has become more established, newer surgical prostheses have been developed with a variety of anchoring systems that do not rely solely on sutures to hold the valve in an appropriate position. The Edwards Intuity valve is a bovine pericardial prosthesis that is modelled on the widely implanted Perimount MagnaEase aortic prosthesis. The Perceval valve is a bovine pericardial valve attached to a self-expanding nitinol stent, which uses the radial force exerted on the patient's aortic annulus and aortic root by the stent portion to hold the valve in position. This meta-analysis compares the outcomes of comparative studies of these two valve systems. Methods: This systematic review and meta-analysis compares the outcomes of rapid deployment valves (RDV) and sutureless valves (SURD) and was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations and guidance. The search strategy interrogated six electronic databases. Outcomes measured included all-cause mortality at latest follow up, stroke, cross-clamp and cardiopulmonary bypass (CPB) times, pacemaker implantation rates, paravalvular leak and post-operative transvalvular gradient. Results: The search strategy identified 407 unique papers for initial assessment with seven studies qualifying for inclusion in the analysis. The outcomes of 4,076 patients (1,650 RDV, 2,426 SURD) were included. There was no difference in mortality, stroke or moderate or worse paravalvular regurgitation between the two groups. SURD had significantly shorter CPB time by 15.7 minutes [95% confidence interval (CI): 4.2-27.1; P=0.007] and a shorter cross-clamp time by 11.3 minutes (95% CI: 6.3-16.3; P<0.001) compared to RDV. RDV had a lower post-operative transvalvular gradient by 2.5 mmHg (95% CI: 1.2-3.8; P<0.001) and a lower rate of mild paravalvular regurgitation (OR 2.51; 95% CI: 1.435-4.768; P=0.004). Conclusions: Both valve types have an adequate safety profile and are comparable to conventional sutured prostheses. There was a significant reduction in cross-clamp and CPB times associated with SURD. This may be of benefit for patients requiring multiple concomitant procedures and increases the utility of minimally invasive valve replacement. However, SURD was associated with higher post-operative transvalvular gradients and a higher incidence of paravalvular regurgitation.

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“…In addition to those unique features, we chose the Intuity valve because of our familiarity and because it has equivocal outcomes to its competitor. 21 Furthermore, there has been at least one case of delayed dislocation of a sutureless valve which required reoperation and securing with pledgeted sutures. 22 Of note, the 3f Enable was withdrawn from the market and was not available for use in this case.…”

Section: Commentsmentioning

confidence: 99%

Placement of a rapid deployment aortic valve in a patient with severely calcified aortic root homograft

et al. 2020

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Significant aortic calcification is a known sequelae of homograft aortic root replacement and creates a treatment challenge if these patients require cardiac reintervention. The standard surgical option for patients requiring an aortic valve replacement in the setting of a calcified aortic homograft has been a Bentall procedure, which is high‐risk with extended cross‐clamp, cardiopulmonary bypass and operative times. We present a patient with a severely calcified aortic homograft who underwent successful valve replacement using a rapid deployment aortic valve leaving the aortic root and arch intact and avoiding the more extensive redo aortic root replacement. Similar cases in the literature are rare.

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Direct Comparison of the Edwards Intuity Elite and Sorin Perceval S Rapid Deployment Aortic Valves

Abstract: Performing RDAVR with the Intuity and Perceval rapid deployment valves provides comparable good clinical outcomes and valve hemodynamics, with low valve-related complication rates. The rate of pacemaker implantation was comparable for both rapid deployment valves, ranging from 8% to 13%.

Cited by 38 publications

References 20 publications

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

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

Sutureless valve and rapid deployment valves: a systematic review and meta-analysis of comparative studies

Placement of a rapid deployment aortic valve in a patient with severely calcified aortic root homograft

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