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One-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial.

ABSTRACT: We aimed to compare 1 year the hemodynamic in-vivo performance of three biological aortic prostheses (Carpentier Perimount Magna EaseTM, Crown PRTTM, and TrifectaTM). The sample used in this study comes from the "BEST-VALVE" clinical trial, which is a phase IV single-blinded randomized clinical trial with the three above-mentioned prostheses. 154 patients were included. Carpentier Perimount Magna EaseTM (n = 48, 31.2%), Crown PRTTM (n = 51, 32.1%) and TrifectaTM (n = 55, 35.7%). One year after the surgery, the mean aortic gradient and the peak aortic velocity was 17.5 (IQR 11.3-26) and 227.1 (IQR 202.0-268.8) for Carpentier Perimount Magna EaseTM, 21.4 (IQR 14.5-26.7) and 237.8 (IQR 195.9-261.9) for Crown PRTTM, and 13 (IQR 9.6-17.8) and 209.7 (IQR 176.5-241.4) for TrifectaTM, respectively. Pairwise comparisons demonstrated improved mean gradients and maximum velocity of TrifectaTM as compared to Crown PRTTM. Among patients with nominal prosthesis sizes ≤ 21, the mean and peak aortic gradient was higher for Crown PRTTM compared with TrifectaTM, and in patients with an aortic annulus measured with metric Hegar dilators less than or equal to 22 mm. One year after surgery, the three prostheses presented a different hemodynamic performance, being TrifectaTM superior to Crown PRTTM.

SUBMITTER: Montero-Cruces L

PROVIDER: S-EPMC8625181 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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One-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial.

Montero-Cruces Lourdes L Carnero-Alcázar Manuel M Reguillo-Lacruz Fernando José FJ Cobiella-Carnicer Francisco Javier FJ Pérez-Camargo Daniel D Campelos-Fernández Paula P Maroto-Castellanos Luis Carlos LC

Journal of clinical medicine 20211116 22

<h4>Background</h4>We aimed to compare 1 year the hemodynamic in-vivo performance of three biological aortic prostheses (Carpentier Perimount Magna Ease<sup>TM</sup>, Crown PRT<sup>TM</sup>, and Trifecta<sup>TM</sup>).<h4>Methods</h4>The sample used in this study comes from the "BEST-VALVE" clinical trial, which is a phase IV single-blinded randomized clinical trial with the three above-mentioned prostheses.<h4>Results</h4>154 patients were included. Carpentier Perimount Magna Ease<sup>TM</sup> ...[more]

PMID: 34830622

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Project description: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.

Project description:Aims of the Study: We evaluated the clinical outcome and the hemodynamic and freedom from structural valve degeneration of two standard aortic bioprostheses. Methods: Clinical results, echocardiographic findings and follow-up data of patients operated for isolated or combined aortic valve replacement with the Perimount or the Trifecta bioprosthesis were prospectively collected, retrospectively analysed and compared. We weighted all the analyses by the inverse of the propensity of choosing either valves. Results: Between April 2015 and December 2019, 168 consecutive patients (all comers) underwent aortic valve replacement with Trifecta (n = 86) or Perimount (n = 82) bioprostheses. Mean age was 70.8 ± 8.6 and 68.8 ± 8.6 years for the Trifecta and Perimount groups, respectively (p = 0.120). Perimount patients presented a greater body mass index (27.6 ± 4.5 vs. 26.0 ± 4.2; p = 0.022), and 23% of them suffered from angina functional class 2-3 (23.2% vs. 5.8%; p = 0.002). Mean ejection fraction was 53.7 ± 11.9% (Trifecta) and 54.5 ± 10.4% (Perimount) (p = 0.994), with mean gradients of 40.4 ± 15.9 mmHg (Trifecta) and 42.3 ± 20.6 mmHg (Perimount) (p = 0.710). Mean EuroSCORE-II was 7 ± 11% and 6 ± 9% for the Trifecta and Perimount group, respectively (p = 0.553). Trifecta patients more often underwent isolated aortic valve replacement (45.3% vs. 26.8%; p = 0.016) and annulus enlargement (10.5% vs. 2.4%; p = 0.058). All-cause mortality at 30 days was 3.5% (Trifecta) and 8.5% (Perimount), (p = 0.203) while new pacemaker implantation (1.2% vs. 2.5%; p = 0.609) and stroke rate (1.2% vs. 2.5%; p = 0.609) were similar. Acute MACCE were observed in 5% (Trifecta) and 9% (Perimount) of patients with an unweighted OR of 2.22 (95%CI 0.64-7.66; p = 0.196) and a weighted OR of 1.10 (95%CI: 0.44-2.76, p = 0.836). Cumulative survival at 24 months was 98% (95%CI: 0.91-0.99) and 96% (95%CI: 0.85-0.99) for Trifecta and Perimount groups, respectively (log-rank test; p = 0.555). The 2-year freedom from MACCE was 94% (95%CI: 0.65-0.99) for Trifecta and 96% (95%CI: 0.86-0.99) for Perimount (log-rank test; p = 0.759, HR 1.46 (95%CI: 0.13-16.48)) in the unweighted analysis (not estimable in the weighted analysis). During the follow-up (median time: 384 vs. 593 days; p = 0.0001) there were no re-operations for structural valve degeneration. Mean valve gradient at discharge was lower for Trifecta across all valve sizes (7.9 ± 3.2 vs. 12.1 ± 4.7 mmHg; p < 0.001), but the difference did not persist during follow-up (8.2 ± 3.7 mmHg for Trifecta, 8.9 ± 3.6 mmHg for Perimount; p = 0.224); Conclusions: Postoperative outcome and mid-term follow-up were similar. An early better hemodynamic performance was detected for the Trifecta valve but did not persist over time. No difference in the reoperation rate for structural valve degeneration was found.

Project description:BackgroundDespite the rapid adoption of transcatheter aortic valve replacement (TAVR) since its initial approval in 2011, the frequency and outcomes of surgical explantation of TAVR devices (TAVR-explant) is poorly understood.MethodsPatients undergoing TAVR-explant between January 2012 and June 2020 at 33 hospitals in Michigan were identified in the Society of Thoracic Surgeons Database and linked to index TAVR data from the Transcatheter Valve Therapy Registry through a statewide quality collaborative. The primary outcome was operative mortality. Indications for TAVR-explant, contraindications to redo TAVR, operative data, and outcomes were collected from Society of Thoracic Surgeons and Transcatheter Valve Therapy databases. Baseline Society of Thoracic Surgeons Predicted Risk of Mortality was compared between index TAVR and TAVR-explant.ResultsTwenty-four surgeons at 12 hospitals performed TAVR-explants in 46 patients (median age, 73). The frequency of TAVR-explant was 0.4%, and the number of explants increased annually. Median time to TAVR-explant was 139 days and among known device types explanted, most were self-expanding valves (29/41, 71%). Common indications for TAVR-explant were procedure-related failure (35%), paravalvular leak (28%), and need for other cardiac surgery (26%). Contraindications to redo TAVR included need for other cardiac surgery (28%), unsuitable noncoronary anatomy (13%), coronary obstruction (11%), and endocarditis (11%). Overall, 65% (30/46) of patients underwent concomitant procedures, including aortic repair/replacement in 33% (n=15), mitral surgery in 22% (n=10), and coronary artery bypass grafting in 16% (n=7). The median Society of Thoracic Surgeons Predicted Risk of Mortality was 4.2% at index TAVR and 9.3% at TAVR-explant (P=0.001). Operative mortality was 20% (9/46) and 76% (35/46) of patients had in-hospital complications. Of patients alive at discharge, 37% (17/37) were discharged home and overall 3-month survival was 73±14%.ConclusionsTAVR-explant is rare but increasing, and its clinical impact is substantial. As the utilization of TAVR expands into younger and lower-risk patients, providers should consider the potential for future TAVR-explant during selection of an initial valve strategy.

Dataset Information

One-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial.

Publications

One-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial.

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