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Mid-term follow-up after aortic valve replacement with the Carpentier Edwards Magna Ease prosthesis.

ABSTRACT: BACKGROUND:Approximately 250,000 heart valve operations are performed annually worldwide. An intensive research and development effort has led to progressively more advanced heart valve prostheses. The Carpentier-Edwards Perimount Magna Ease (CEPME) prosthesis represents the latest iteration of the Edwards Perimount series of aortic tissue valves. The current study aims to evaluate the midterm performance of this bioprosthesis. METHODS:Five hundred and eighteen patients with aortic stenosis underwent aortic valve replacement with the CEPME valve at Papworth Hospital between August 2008 and November 2011. After a minimum of 3?years from the index operation, eligible patients were retrospectively and consecutively recruited to participate. Recruitment was closed after 100 eligible patients had completed all study assessments. Investigations at follow-up included echocardiography, and NYHA status. Primary endpoints included valve performance measures. RESULTS:The mean age was 72?years, 64% were male and median follow-up was 5.1?years. NYHA status had improved in 66% of patients. The average postoperative peak and mean pressure gradients decreased by 51.2?mmHg (64.5%) and 31.8?mmHg (59.4%), with a significant improvement in NYHA status. The frequency of moderate aortic regurgitation was 3%. There was no evidence for structural valve deterioration. CONCLUSIONS:The CEPME has excellent mid-term durability. Its use effectively improves haemodynamics and functional capacity.

SUBMITTER: Rajab TK

PROVIDER: S-EPMC7397680 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Mid-term follow-up after aortic valve replacement with the Carpentier Edwards Magna Ease prosthesis.

Rajab Taufiek K TK Ali Jason M JM Hernández-Sánchez Jules J Mackie Jennifer J Grimaudo Vincenzo V Sinichino Silvia S Mills Christine C Rana Bushra B Dunning John J Abu-Omar Yasir Y

Journal of cardiothoracic surgery 20200803 1

<h4>Background</h4>Approximately 250,000 heart valve operations are performed annually worldwide. An intensive research and development effort has led to progressively more advanced heart valve prostheses. The Carpentier-Edwards Perimount Magna Ease (CEPME) prosthesis represents the latest iteration of the Edwards Perimount series of aortic tissue valves. The current study aims to evaluate the midterm performance of this bioprosthesis.<h4>Methods</h4>Five hundred and eighteen patients with aorti ...[more]

PMID: 32746882

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Project description:ObjectivesSutureless and rapid-deployment valves were recently introduced into clinical practice. The Edwards INTUITY valve system is a combination of the Edwards Magna pericardial valve and a subvalvular stent-frame to enable rapid deployment. We performed a parallel cohort study for comparison of the two valve types.MethodsAll patients receiving either an Edwards Magna Ease valve or an Edwards INTUITY valve system due to aortic stenosis from May 2010 until July 2014 were included. Patients undergoing bypass surgery, an additional valve procedure, atrial ablation surgery or replacement of the ascending aorta were excluded. Preoperative characteristics, operative specifications, survival, valve-related adverse events and transvalvulvar gradients were compared.ResultsOne hundred sixteen patients underwent rapid-deployment aortic valve replacement [mean age 75 years (SD: 8); 62% female] and 132 patients underwent conventional aortic valve replacement [70 years (SD: 9); 31% female; P < 0.001]. Conventional valve patients were taller and heavier. The mean EuroSCORE II was 3.1% (SD: 2.7) and 4.4% (SD: 6.0) for rapid-deployment and conventional valve patients, respectively (P = 0.085). The mean implanted valve size was higher in the conventional group [23.2 mm (SD: 2.0) vs 22.5 mm (SD: 2.2); P = 0.007], but postoperative transvalvular mean gradients were comparable [15 mmHg (SD: 6) vs 14 mmHg (SD: 5); P = 0.457]. A subgroup analysis of the most common valve sizes (21 and 23 mm; implanted in 63% of patients) revealed significantly reduced mean postoperative transvalvular gradients in the rapid-deployment group [14 mmHg (SD: 4) vs 16 mmHg (SD: 5); P = 0.025]. A significantly higher percentage received minimally invasive procedures in the rapid-deployment group (59 vs 39%; P < 0.001). The 1- and 3-year survival rate was 96 and 90% in the rapid-deployment group and 95 and 89% in the conventional group (P = 0.521), respectively. Valve-related pacemaker implantations were more common in the rapid-deployment group (9 vs 2%; P = 0.014) and postoperative stroke was more common in the conventional group (1.6 vs 0% per patient year; P = 0.044).ConclusionsWe conclude that this rapid-deployment valve probably facilitates minimally invasive surgery. Furthermore, a subgroup analysis showed reduced transvalvular gradients in smaller valve sizes compared with the conventionally implanted valve of the same type. The favourable haemodynamic profile and the potentially different spectrum of valve-related adverse events should be addressed in further clinical trials.

Project description:ObjectivesThis study was designed to describe Doppler-echocardiography values of Carpentier-Edwards Perimount Standard (CEPS) and Carpentier-Edwards Perimount Magna (CEPM) aortic prosthetic valves, evaluated by a single, experienced echo-laboratory, early in the postoperative phase.MethodsThree-hundred-seventy-seven consecutive patients, who had had a CEPS or a CEPM implanted in our Hospital due to aortic stenosis and/or insufficiency, underwent baseline Doppler echocardiography evaluation within 7 days after surgery. Hemodynamic performances of CEPS and CEPM were accurately described, evaluating flow-dependent (transprosthetic velocities and gradients) and flow-independent (effective orifice area, indexed effective orifice area and Doppler velocity index) Doppler-echocardiography parameters.ResultsOut of the 377 patients 48.8% were men (n = 184), mean age was 74.63 ± 6.77 years, mean BSA was 1.78 ± 0.18 m2, mean ejection fraction was 57.78 ± 8%. Two-hundred and sixty two CEPS and 115 CEPM were implanted. Comparing size-by-size CEPS with CEPM, both prostheses showed a good hemodynamic profile, with fairly similar values of pressure gradients (PGmax and mean, in mmHg, = 37,18 ± 11.57 and 20.81 ± 7.44 in CEPS n°19 compared to 32,47 ± 7,76 and 17,67 ± 4.63 in CEPM n°19 and progressively lower in higher sized prostheses, having PGmax and mean 15 ± 3,16 and 9.15 ± 1,29 in CEPS n°29 compared to 15,67 ± 1,53 and 9 ± 1 in CEPM n°29) and EOAi (being 0,65 ± 0,33 cm²/m² in CEPS n°19 compared to 0,77 ± 0,29 cm²/m² in CEPM n°19 and progressively higher in higher sized prostheses, being 1,28 ± 0,59 cm²/m² in CEPS n°29 compared to 1,07 ± 0,18 cm²/m² in CEPM n°29), the latter resulting, however, basically less flow obstructive.ConclusionsOur data confirm the good hemodynamic performance of both aortic bioprostheses and the more favourable hemodynamic profile of CEPM compared to CEPS, pointing out the need to perform routinely an accurate baseline Doppler-echocardiography evaluation early after surgery to allow an adequate interpretation of data at follow-up.

Project description:Previous studies of the cost-effectiveness of transcatheter aortic valve replacement (TAVR) have been based primarily on a single balloon-expandable system.The goal of this study was to evaluate the cost-effectiveness of TAVR with a self-expanding prosthesis compared with surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis and high surgical risk.We performed a formal economic analysis on the basis of individual, patient-level data from the CoreValve U.S. High Risk Pivotal Trial. Empirical data regarding survival and quality of life over 2 years, and medical resource use and hospital costs through 12 months were used to project life expectancy, quality-adjusted life expectancy, and lifetime medical costs in order to estimate the incremental cost-effectiveness of TAVR versus SAVR from a U.S.Relative to SAVR, TAVR reduced initial length of stay an average of 4.4 days, decreased the need for rehabilitation services at discharge, and resulted in superior 1-month quality of life. Index admission and projected lifetime costs were higher with TAVR than with SAVR (differences $11,260 and $17,849 per patient, respectively), whereas TAVR was projected to provide a lifetime gain of 0.32 quality-adjusted life-years ([QALY]; 0.41 LY) with 3% discounting. Lifetime incremental cost-effectiveness ratios were $55,090 per QALY gained and $43,114 per LY gained. Sensitivity analyses indicated that a reduction in the initial cost of TAVR by ?$1,650 would lead to an incremental cost-effectiveness ratio <$50,000/QALY gained.In a high-risk clinical trial population, TAVR with a self-expanding prosthesis provided meaningful clinical benefits compared with SAVR, with incremental costs considered acceptable by current U.S.With expected modest reductions in the cost of index TAVR admissions, the value of TAVR compared with SAVR in this patient population would become high. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve U.S. Pivotal Trial]; NCT01240902).

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Mid-term follow-up after aortic valve replacement with the Carpentier Edwards Magna Ease prosthesis.

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Mid-term follow-up after aortic valve replacement with the Carpentier Edwards Magna Ease prosthesis.

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