Rapid Deployment Versus Conventional Bioprosthetic Valve Replacement for Aortic Stenosis

Ensminger, Stephan; Fujita, Buntaro; Bauer, Timm; Möllmann, Helge; Beckmann, Andreas; Bekeredjian, Raffi; Bleiziffer, Sabine; Landwehr, Sandra; Hamm, Christian W.; Mohr, Friedrich W.; Katus, Hugo A.; Harringer, Wolfgang; Walther, Thomas; Frerker, Christian

doi:10.1016/j.jacc.2018.01.065

Cited by 107 publications

(141 citation statements)

References 24 publications

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“…Larger studies describe an increased risk of transient ischemic attacks (1.1%) and strokes (2.2-2.8%) after use of RPD. 13,14 We did not observe elevated rates of neurologic events in our RPD cohorts.…”

Section: Clinical Outcomes According To Varc-2contrasting

confidence: 45%

Hemodynamic Comparison of Sutureless and Rapid-Deployment Valves with Conventional Bioprostheses

Gotzmann

Wilbring²,

Charitos

et al. 2019

Thorac Cardiovasc Surg

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Background Sutureless and rapid-deployment bioprostheses (RPDs) are advantageous due to shorter aortic cross-clamp times (ACCs); however, few studies have investigated hemodynamic outcomes in comparison to conventional bioprostheses (CBs). Methods All patients receiving the Perceval (LivaNova, London, United Kingdom) and Intuity (Edwards Lifesciences, Irvine, California, United States) valves from February 2016 to December 2017 were included (n = 61). For controls, patients who underwent aortic valve replacement using CB from 2015 to 2018 (n = 743) were propensity-matched (n = 108). Primary end points were mean gradient at discharge, true internal diameter (ID) after implantation, and paravalvular leakage. Secondary end points were ACCs, cardiopulmonary bypass times (CPBTs), mortality, and pacemaker implantation. Results Age was 73.2 years (standard deviation [SD]: 7.6) in the RPD group and 72.9 years (SD: 7.3) in the CB group (p = 0.827). Median logistic EuroSCORE II was 3.4% (Q1: 2; IQ3: 5.3) and 3% (Q1: 1.9; IQ3: 5.6; p = 0.599). While ACCs and CPBT were shorter in RPDs (97 [SD: 31.4] vs. 125.4 minutes [SD: 62.1], p = 0.003; and 76.1 [SD: 25.7] vs. 89.7 minutes [SD: 34.3], p = 0.022), procedural times were similar (p = 0.257). True ID was 21.97 mm (SD: 1.79) in RPDs and 20.15 mm (SD: 1.70) in CB (p < 0.001).RPDs and CB resulted in comparable mean gradients (12.8 mm Hg [SD: 6.4] vs. 13.8 mm Hg [SD: 5.6]; p = 0.387) and rate of paravalvular regurgitation. There were no differences in the rates of pacemaker implantation and mortality.In a subanalysis of RPDs, mean gradient was 15.48 mm Hg (SD: 7.51) in Perceval (n = 21) and 10.79 mm Hg (SD: 4.78) in Intuity (n = 33; p = 0.010). Conclusions RPDs provided comparable hemodynamic performance, although implanted valves were larger in true ID. Whether this provides superior hemodynamic performance during exercise and longer durability needs further investigation. Among RPDs, the Intuity valve provided lower mean gradients at rest than Perceval valve.

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Section: Clinical Outcomes According To Varc-2contrasting

confidence: 45%

Hemodynamic Comparison of Sutureless and Rapid-Deployment Valves with Conventional Bioprostheses

Gotzmann

Wilbring²,

Charitos

et al. 2019

Thorac Cardiovasc Surg

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“…13 In addition, the 30-day mortality in the GARY registry for combined RDAVR procedures was 2.7%, which was lower than the reported 3.5% mortality in the SURD-AVR registry. 9,19 With respect to the need for a permanent pacemaker after RDAVR, we found a trend to a higher rate for both RDV types in patients undergoing combined procedures (Perceval 9.7% and Intuity 15.6%) compared with isolated RDAVR. These rates are in compliance with previous studies that report pacemaker implantation rates of 6 to 11% for the Perceval S and up to 12% for the Intuity Elite.…”

Section: Discussionmentioning

confidence: 81%

“…Previous studies from our group and others have repeatedly documented for both RDVs good durability, hemodynamic performance, and clinical results. [9][10][11][12][13][14] However, the clinical benefits using the Intuity Elite and Perceval S RDVs compared with conventional AVR was recently questioned by data from the all-comers German Aortic Valve Registry (GARY), which showed a higher periprocedural stroke rate, need for permanent pacemaker implantation, and mean pressure gradients (MPGs) following RDV use. 9 Importantly, distinct differences were found with regard to the RDV type, with the self-expanding Perceval S showing a higher permanent pacemaker implantation rate and MPG compared with the balloon-expandable Intuity Elite.…”

Section: Introductionmentioning

confidence: 99%

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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“…The most common complications reported in the case of RD-AVR are higher incidence of pacemaker implantation, postoperative stroke and residual aortic regurgitation [20] , while the most common complications reported in the case of standard procedure tend to be exclusively surgery related as major bleeding or acute renal failure [21] . Totally in contrast to these previous studies, the German Aortic Valve Registry (GARY) recently analyzed a total of 22,062 patients who underwent isolated SAVR using SAVR or RD-AVR between 2011 and 2015 [22] . GARY analysis demonstrated that the advantages carried by RD-AVR may not translate into effective benefits.…”

Section: Discussionmentioning

confidence: 99%

Bridging aortic valve surgery to 21st century: what can a surgeon do?

D'Abramo¹,

Ferrante²,

Guimarães³

et al. 2019

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Aortic valve stenosis is the most clinically relevant valvular heart disease in the elderlies. Surgical aortic valve replacement (SAVR) represented, for decades, the standard of care for the treatment of severe aortic stenosis. Although SAVR still represents a valid option in this clinical scenario, transcatheter aortic valve implantation proved to be superior to medical therapy and comparable to SAVR in several randomized trials in patients at high or intermediate operative risk. At the same time, the growing aging population carrying on greater morbidities and high risk profiles has led to the development of minimally invasive technologies, as rapid deployment aortic valve replacement or Sutureless, to minimize surgical impact on patients. The Heart Team is nowadays tasked to determine the best option tailored for each patient considering patient-related factors and mastering all the surgical options in terms of both different techniques and types of available valves. Nevertheless, some open issues need to be already answered as: which has the longest durability, which the lower complication rate and the lower overall mortality. The aim of this review is to briefly resume the main features of these different options and explore what kind of open questions these newer-generation prosthetic valves and delivery devices carry.

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Rapid Deployment Versus Conventional Bioprosthetic Valve Replacement for Aortic Stenosis

Cited by 107 publications

References 24 publications

Hemodynamic Comparison of Sutureless and Rapid-Deployment Valves with Conventional Bioprostheses

Hemodynamic Comparison of Sutureless and Rapid-Deployment Valves with Conventional Bioprostheses

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

Bridging aortic valve surgery to 21st century: what can a surgeon do?

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