Dataset Information

Outcomes comparison of different surgical strategies for the management of severe aortic valve stenosis: study protocol of a prospective multicentre European registry (E-AVR registry).

ABSTRACT: Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life expectancy. Recent randomised controlled trials (RCTs) reported comparable or non-inferior mortality with transcatheter treatments compared with traditional surgery. However, RCTs have the limitation of being a mirror of the predefined inclusion/exclusion criteria, without reflecting the 'real clinical world'. Technological improvements have recently allowed the development of minimally invasive surgical accesses and the use of sutureless valves, but their impact on the clinical scenario is difficult to assess because of the monocentric design of published studies and limited sample size. A prospective multicentre registry including all patients referred for a surgical treatment of SAVS (traditional, through full sternotomy; minimally invasive; or transcatheter; with both 'sutured' and 'sutureless' valves) will provide a 'real-world' picture of available results of current surgical options and will help to clarify the 'grey zones' of current guidelines.European Aortic Valve Registry is a prospective observational open registry designed to collect all data from patients admitted for SAVS, with or without coronary artery disease, in 16 cardiac surgery centres located in six countries (France, Germany, Italy, Spain, Switzerland and UK). Patients will be enrolled over a 2-year period and followed up for a minimum of 5 years to a maximum of 10 years after enrolment. Outcome definitions are concordant with Valve Academic Research Consortium-2 criteria and established guidelines. Primary outcome is 5-year all-cause mortality. Secondary outcomes aim at establishing 'early' 30-day all-cause and cardiovascular mortality, as well as major morbidity, and 'late' cardiovascular mortality, major morbidity, structural and non-structural valve complications, quality of life and echocardiographic results.The study protocol is approved by local ethics committees. Any formal presentation or publication of data will be considered as a joint publication by the participating physician(s) and will follow the recommendations of the International Committee of Medical Journal Editors for authorship.NCT03143361; Pre-results.

SUBMITTER: Onorati F

PROVIDER: S-EPMC5829669 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Outcomes comparison of different surgical strategies for the management of severe aortic valve stenosis: study protocol of a prospective multicentre European registry (E-AVR registry).

Onorati Francesco F Gherli Riccardo R Mariscalco Giovanni G Girdauskas Evaldas E Quintana Eduardo E Santini Francesco F De Feo Marisa M Sponga Sandro S Tozzi Piergiorgio P Bashir Mohamad M Perrotti Andrea A Pappalardo Aniello A Ruggieri Vito Giovanni VG Santarpino Giuseppe G Rinaldi Mauro M Ronaldo Silva S Nicolini Francesco F

BMJ open 20180210 2

<h4>Introduction</h4>Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life expectancy. Recent randomised controlled trials (RCTs) reported comparable or non-inferior mortality with transcatheter treatments compared with traditional surgery. However, RCTs have the limitation of being a mirror of the predefined inclusion/exclusion criteria, without reflecting the 'real clinical world'. Technological improvements h ...[more]

PMID: 29440154

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Project description:Recently, two randomized trials, the PARTNER 3 and the Evolut Low Risk Trial, independently demonstrated that transcatheter aortic valve replacement (TAVR) is non-inferior to surgical aortic valve replacement (SAVR) for the treatment of severe aortic stenosis in patients at low surgical risk, paving the way to a progressive extension of clinical indications to TAVR. We designed a meta-analysis to compare TAVR versus SAVR in patients with severe aortic stenosis at low surgical risk. The study protocol was registered in PROSPERO (CRD42019131125). Randomized studies comparing one-year outcomes of TAVR or SAVR were searched for within Medline, Scholar and Scopus electronic databases. A total of three randomized studies were selected, including nearly 3000 patients. After one year, the risk of cardiovascular death was significantly lower with TAVR compared to SAVR (Risk Ratio (RR) = 0.56; 95% CI 0.33-0.95; p = 0.03). Conversely, no differences were observed between the groups for one-year all-cause mortality (RR = 0.67; 95% CI 0.42-1.07; p = 0.10). Among the secondary endpoints, patients undergoing TAVR have lower risk of new-onset of atrial fibrillation compared to SAVR (RR = 0.26; 95% CI 0.17-0.39; p < 0.00001), major bleeding (RR = 0.30; 95% CI 0.14-0.65; p < 0.002) and acute kidney injury stage II or III (RR = 0.28; 95% CI 0.14-0.58; p = 0.0005). Conversely, TAVR was associated to a higher risk of aortic regurgitation (RR = 3.96; 95% CI 1.31-11.99; p = 0.01) and permanent pacemaker implantation (RR = 3.47; 95% CI 1.33-9.07; p = 0.01) compared to SAVR. No differences were observed between the groups in the risks of stroke (RR= 0.71; 95% CI 0.41-1.25; p = 0.24), transient ischemic attack (TIA; RR = 0.98; 95% CI 0.53-1.83; p = 0.96), and MI (RR = 0.75; 95% CI 0.43-1.29; p = 0.29). In conclusion, the present meta-analysis, including three randomized studies and nearly 3000 patients with severe aortic stenosis at low surgical risk, shows that TAVR is associated with lower CV death compared to SAVR at one-year follow-up. Nevertheless, paravalvular aortic regurgitation and pacemaker implantation still represent two weak spots that should be solved.

Project description:ObjectiveData on statin for patients with aortic stenosis (AS) who underwent transcatheter aortic valve implantation (TAVI) are limited. The present study aimed to evaluate the impact of statin on midterm mortality of TAVI patients.DesignObservational study.SettingThis study included patients with AS from a Japanese multicentre registry who underwent TAVI.ParticipantsThe overall cohort included 2588 patients (84.4±5.2 years); majority were women (69.3%). The Society of Thoracic Surgeons risk score was 6.55% (IQR 4.55%-9.50%), the Euro II score was 3.74% (IQR 2.34%-6.02%) and the Clinical Frailty Scale score was 3.9±1.2.InterventionsWe classified patients based on statin at admission and identified 936 matched pairs after propensity score matching.Primary and secondary outcome measuresThe outcomes were all-cause and cardiovascular mortality.ResultsThe median follow-up was 660 days. Statin at admission was associated with a significant reduction in all-cause mortality (adjusted HR (aHR) 0.76, 95% CI 0.58 to 0.99, p=0.04) and cardiovascular mortality (aHR 0.64, 95% CI 0.42 to 0.97, p=0.04). In the octogenarians, statin was associated with significantly lower all-cause mortality (aHR 0.87, 95% CI 0.75 to 0.99, p=0.04); however, the impact in the nonagenarians appeared to be lower (aHR 0.84, 95% CI 0.62 to 1.13, p=0.25). Comparing four groups according to previous coronary artery disease (CAD) and statin, there was a significant difference in all-cause mortality, and patients who did not receive statin despite previous CAD showed the worst prognosis (aHR 1.33, 95% CI 1.12 to 1.57 (patients who received statin without previous CAD as a reference), p<0.01).ConclusionsStatin for TAVI patients will be beneficial even in octogenarians, but the benefits may disappear in nonagenarians. In addition, statin will be essential for TAVI patients with CAD. Further research is warranted to confirm and generalise our findings since this study has the inherent limitations of an observational study and included only Japanese patients.Trial registration numberUMIN000020423.

Project description:BackgroundCirculatory efficiency reflects the ratio between total left ventricular work and the work required for maintaining cardiovascular circulation. The effect of severe aortic valve stenosis (AS) and aortic valve replacement (AVR) on left ventricular/circulatory mechanical power and efficiency is not yet fully understood. We aimed to quantify left ventricular (LV) efficiency in patients with severe AS before and after surgical AVR.MethodsCirculatory efficiency was computed from cardiovascular magnetic resonance (CMR) imaging derived volumetric data, echocardiographic and clinical data in patients with severe AS (n?=?41) before and 4 months after AVR and in age and sex-matched healthy subjects (n?=?10).ResultsIn patients with AS circulatory efficiency was significantly decreased compared to healthy subjects (9?±?3% vs 12?±?2%; p?=?0.004). There were significant negative correlations between circulatory efficiency and LV myocardial mass (r?=?-?0.591, p?<?0.001), myocardial fibrosis volume (r?=?-?0.427, p?=?0.015), end systolic volume (r?=?-?0.609, p?<?0.001) and NT-proBNP (r?=?-?0.444, p?=?0.009) and significant positive correlation between circulatory efficiency and LV ejection fraction (r?=?0.704, p?<?0.001). After AVR, circulatory efficiency increased significantly in the total cohort (9?±?3 vs 13?±?5%; p?<?0.001). However, in 10/41 (24%) patients, circulatory efficiency remained below 10% after AVR and, thus, did not restore to normal values. These patients also showed less reduction in myocardial fibrosis volume compared to patients with restored circulatory efficiency after AVR.ConclusionIn our cohort, circulatory efficiency is reduced in patients with severe AS. In 76% of cases, AVR leads to normalization of circulatory efficiency. However, in 24% of patients, circulatory efficiency remained below normal values even after successful AVR. In these patients also less regression of myocardial fibrosis volume was seen. Trial Registration clinicaltrials.gov NCT03172338, June 1, 2017, retrospectively registered.

Dataset Information

Outcomes comparison of different surgical strategies for the management of severe aortic valve stenosis: study protocol of a prospective multicentre European registry (E-AVR registry).

Publications

Outcomes comparison of different surgical strategies for the management of severe aortic valve stenosis: study protocol of a prospective multicentre European registry (E-AVR registry).

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