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Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study.

ABSTRACT: The ADVANCE study was designed to evaluate the safety and effectiveness of transcatheter aortic valve implantation (TAVI) with a self-expanding bioprosthesis in real-world patients with symptomatic, severe aortic stenosis at high surgical risk for valve replacement.Study participants were enrolled from 44 experienced centres in 12 countries. Patient eligibility, treatment approach, and choice of anaesthesia were determined by the local Heart Team. The study was 100% monitored, and adverse events were adjudicated by an independent clinical events committee using Valve Academic Research Consortium (VARC-1) criteria. There were 1015 patients enrolled with 996 attempted TAVI procedures. Mean age was 81?years, and mean logistic EuroSCORE was 19.3?±?12.3%. Five-year follow-up was available on 465 (46.7%) patients. At 5?years, the rate of all-cause mortality was 50.7% (95% confidence interval: 46.7%, 54.5%), and the rate of major stroke was 5.4%. Haemodynamic measures remained consistent for paired patients with a mean aortic valve gradient of 8.8?±?4.4?mmHg (n?=?198) and an effective orifice area of 1.7?±?0.4?cm2 (n?=?123). Aortic regurgitation (AR) decreased over time and among paired patients dropped from 12.8% to 8.0% moderate AR at 5?years (n?=?125). Of the 860 patients with echocardiographic data or a reintervention after 30 days, there were 22 (2.6%) patients meeting the VARC-2 criteria for valve dysfunction and 10 (1.2%) patients with a reintervention >30 days.Five-year results in real-world, elderly, high-risk patients undergoing TAVI with a self-expanding bioprosthesis provided evidence for continued valve durability with low rates of reinterventions and haemodynamic valve dysfunction.ClinicalTrials.gov, NCT01074658.

SUBMITTER: Gerckens U

PROVIDER: S-EPMC5837353 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study.

Gerckens Ulrich U Tamburino Corrado C Bleiziffer Sabine S Bosmans Johan J Wenaweser Peter P Brecker Stephen S Guo Jia J Linke Axel A

European heart journal 20170901 36

<h4>Aims</h4>The ADVANCE study was designed to evaluate the safety and effectiveness of transcatheter aortic valve implantation (TAVI) with a self-expanding bioprosthesis in real-world patients with symptomatic, severe aortic stenosis at high surgical risk for valve replacement.<h4>Methods and results</h4>Study participants were enrolled from 44 experienced centres in 12 countries. Patient eligibility, treatment approach, and choice of anaesthesia were determined by the local Heart Team. The stu ...[more]

PMID: 28633375

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Project description:ImportanceIn the CoreValve High-Risk Trial, patients with severe symptomatic aortic stenosis had similar clinical outcomes with transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) over 5 years of follow-up, with mortality rates of more than 50% in both groups.ObjectiveTo describe the long-term health status of surviving patients randomized to self-expanding TAVR vs SAVR.Design, setting, and participantsThis randomized clinical trial included patients at high surgical risk with severe aortic stenosis who completed a baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and were randomized to either self-expanding TAVR or SAVR from 45 US clinical sites. Patients were enrolled from February 2011 to September 2012. Analysis began May 2018 and ended June 2020.Main outcomes and measuresChange in KCCQ and the 12-Item Short-Form Health Survey over 5 years, as assessed by repeated-measures analysis of covariance. Because there were significant interactions between access site and treatment for 1-month health status outcomes, all analyses were stratified by access site (iliofemoral or noniliofemoral).ResultsOf 713 patients, 377 (53%) were men, and the mean (SD) age was 83 (7) years. Prior to treatment, the mean (SD) KCCQ overall summary score (range, 0-100; higher score indicated better health status) was 47 (23), indicating substantial health status impairment. Among surviving patients, the KCCQ overall summary score increased significantly in both groups with greater early benefit with iliofemoral TAVR than SAVR (1-month difference, 16.8 points; 95% CI, 12.4-21.2). However, this early treatment difference between TAVR and SAVR was no longer apparent by 6 months, and there was no significant difference in health status between groups thereafter. At 5 years, 44% (134 of 305) of patients who underwent iliofemoral TAVR and 39% (105 of 266) who underwent SAVR were alive in this high-risk elderly cohort. Among surviving patients for whom health status data were available, 61% (48 of 79) in the TAVR group and 65% (46 of 71) in the SAVR group had KCCQ overall summary score more than 60 (P = .61). In the noniliofemoral cohort, there were no significant health status differences at any time between TAVR and SAVR. Results were similar for individual KCCQ domains and the Short-Form Health Survey.Conclusions and relevanceIn high-risk patients with severe symptomatic aortic stenosis, there was an early health status benefit with self-expanding iliofemoral TAVR vs SAVR but no difference between groups in long-term health status. Although mortality at 5 years was high in this population, the majority of surviving patients continued to report reasonable health status.Trial registrationClinicalTrials.gov Identifier: NCT01240902.

Project description:BackgroundThe 2016 guidelines of the American Society of Echocardiography (ASE) and European Association of Cardiovascular Imaging (EACVI) for evaluation of left ventricular (LV) diastolic dysfunction by Doppler flow and tissue Doppler- echocardiography do not adjust assessment of high filling pressures for patients with aortic stenosis (AS). However, most of the studies on this patient group indicate age independent specific diastolic features in AS. The aim of this study is to identify disease-specific range and distribution of diastolic functional parameters and their ability to identify high N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels as a marker for high filling pressures.MethodsIn this study, 169 patients who underwent surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) were prospectively enrolled. Resting echocardiography was performed including Doppler of the mitral inflow, pulmonary venous flow, tricuspid regurgitant flow and tissue Doppler in the mitral ring and indexed volume-estimates of the left atrium (LAVI). Echocardiography, and NT-proBNP levels were assessed before TAVR/SAVR and at two postoperative visits at 6 and 12 months.ResultsPre- and postoperative values were septal e'; 5.1 ± 3.9, 5.2 ± 1.6 cm/s; lateral e' 6.3 ± 2.1; 7.7 ± 2.7 cm/s; E/e'19 ± 8; 16 ± 7 cm/s; E velocity 96 ± 32; 95 ± 32 cm/s; LAVI 39 ± 8; 36 ± 8 ml/m2, pulmonary artery pressure (PAP) 39 ± 8; 36 ± 8 mmHg, respectively. The scoring recommended by ASE/EACVI detected elevated NT pro-BNP with a specificity of 25%. Adjusting thresholds towards PAP ≥ 40 mmHg, E velocity ≥ 100 cm/s, E deceleration time < 220 ms, and E/septal e' ≥ 20 or septal e' < 5.0 cm/s increased prediction of NT-proBNP levels ≥500 ng/L with substantially improved specificity (> 85%).ConclusionDiastolic echocardiographic parameters in AS indicate persistent impaired relaxation and NT-proBNP indicate elevated filling pressures in most of the patients, improving only modestly 6-12 months after TAVR and SAVR. Applying the 2016 ASE/EACVI recommendations for detection of elevated filling pressures to patients with AS, elevated NT pro-BNP levels could not be reliably detected. However, adjusting thresholds of the echocardiographic parameters increased specificities to useful diagnostic levels.Trial registrationThe study was prospectively approved by the regional ethical committee, REK North with the registration number: REK 2010/397-10 .

Project description:ObjectivesThe Carpentier-Edwards Perimount Magna Ease (Edwards Lifesciences) pericardial bioprosthesis has demonstrated satisfying hemodynamics at midterm follow-up, but its durability remains unclear. We report our 10-year experience with this third-generation valve implanted in the aortic position, with particular attention to structural valve deterioration.MethodsFrom 2007 to 2016 at our center, 338 patients underwent aortic valve replacement using the Perimount Magna Ease pericardial bioprosthesis. Patients were prospectively followed (mean 6.6 ± 2.6 years) with clinical evaluation and yearly echocardiography. Follow-up was 98% complete (7 patients lost) for a total of 2238 valve-years. Bioprosthesis structural valve deterioration was determined by strict echocardiographic assessment based on the Valve Academic Research Consortium 3 criteria.ResultsOverall operative mortality was 1.2%. Actuarial survival including early deaths averaged 80.9% ± 2.2% and 66.7% ± 4.4% after 5 and 10 years of follow-up, respectively. Actuarial freedom from explantation due to structural valve deterioration at 5 and 10 years was 99.6% ± 0.4% and 88.8% ± 5.0%, respectively, and actuarial freedom of structural valve deterioration at 5 and 10 years was 98.5% ± 0.7% and 44.0% ± 6.4%, respectively. More precisely, actuarial freedom of structural valve deterioration stage 3 was 99.6% ± 0.4% at 5 years and 88.3% ± 5.0% at 10 years, whereas freedom of structural valve deterioration stage 2/3 was 98.5% ± 0.7% and 60.9% ± 7.0%, respectively.ConclusionsWith a low rate of explantation due to structural valve deterioration events at 10 years, and particularly a low rate of moderate or severe structural valve deterioration based on echocardiographic Valve Academic Research Consortium 3 criteria, the Carpentier-Edwards Perimount Magna Ease pericardial bioprosthesis remains a reliable choice for a tissue valve in the aortic position.Video abstract

Dataset Information

Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study.

Publications

Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study.

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