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

Aims: 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. Methods and results: 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. Conclusion: 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. Trial registration: ClinicalTrials.gov, NCT01074658

Long-Term Outcomes After Transcatheter Aortic Valve Implantation in High-Risk Patients With Severe Aortic Stenosis The U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry

ObjectivesThe objective was to define the characteristics of a real-world patient population treated with transcatheter aortic valve implantation (TAVI), regardless of technology or access route, and to evaluate their clinical outcome over the mid to long term.BackgroundAlthough a substantial body of data exists in relation to early clinical outcomes after TAVI, there are few data on outcomes beyond 1 year in any notable number of patients.MethodsThe U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry was established to report outcomes of all TAVI procedures performed within the United Kingdom. Data were collected prospectively on 870 patients undergoing 877 TAVI procedures up until December 31, 2009. Mortality tracking was achieved in 100% of patients with mortality status reported as of December 2010.ResultsSurvival at 30 days was 92.9%, and it was 78.6% and 73.7% at 1 year and 2 years, respectively. There was a marked attrition in survival between 30 days and 1 year. In a univariate model, survival was significantly adversely affected by renal dysfunction, the presence of coronary artery disease, and a nontransfemoral approach; whereas left ventricular function (ejection fraction <30%), the presence of moderate/severe aortic regurgitation, and chronic obstructive pulmonary disease remained the only independent predictors of mortality in the multivariate model.ConclusionsMidterm to long-term survival after TAVI was encouraging in this high-risk patient population, although a substantial proportion of patients died within the first year

Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study

Aim Transcatheter aortic valve implantation has become an alternative to surgery in higher risk patients with symptomatic aortic stenosis. The aim of the ADVANCE study was to evaluate outcomes following implantation of a self-expanding transcatheter aortic valve system in a fully monitored, multi-centre ‘real-world' patient population in highly experienced centres. Methods and results Patients with severe aortic stenosis at a higher surgical risk in whom implantation of the CoreValve System was decided by the Heart Team were included. Endpoints were a composite of major adverse cardiovascular and cerebrovascular events (MACCE; all-cause mortality, myocardial infarction, stroke, or reintervention) and mortality at 30 days and 1 year. Endpoint-related events were independently adjudicated based on Valve Academic Research Consortium definitions. A total of 1015 patients [mean logistic EuroSCORE 19.4 ± 12.3% [median (Q1,Q3), 16.0% (10.3, 25.3%)], age 81 ± 6 years] were enrolled. Implantation of the CoreValve System led to a significant improvement in haemodynamics and an increase in the effective aortic valve orifice area. At 30 days, the MACCE rate was 8.0% (95% CI: 6.3-9.7%), all-cause mortality was 4.5% (3.2-5.8%), cardiovascular mortality was 3.4% (2.3-4.6%), and the rate of stroke was 3.0% (2.0-4.1%). The life-threatening or disabling bleeding rate was 4.0% (2.8-6.3%). The 12-month rates of MACCE, all-cause mortality, cardiovascular mortality, and stroke were 21.2% (18.4-24.1%), 17.9% (15.2-20.5%), 11.7% (9.4-14.1%), and 4.5% (2.9-6.1%), respectively. The 12-month rates of all-cause mortality were 11.1, 16.5, and 23.6% among patients with a logistic EuroSCORE ≤10%, EuroSCORE 10-20%, and EuroSCORE >20% (P< 0.05), respectively. Conclusion The ADVANCE study demonstrates the safety and effectiveness of the CoreValve System with low mortality and stroke rates in higher risk real-world patients with severe aortic stenosi

Sheff vs. O\u27Neill, Connecticut\u27s landmark desegregation case

On April 18, 1989, eighteen school aged children from the metropolitan Hartford, Connecticut area, acting through their parents, commenced a civil action in the Hartford Superior Court. The suit named the State of Connecticut, constitutionally elected officials, and officials of various state commissions and agencies as defendants. The plaintiffs alleged significant constitutional violations under applicable sections of the State constitution which they believe constituted a denial of their fundamental rights to an education and rights to equal protection under the law. In the landmark civil rights decision of Sheff v. O\u27Neill, the Connecticut Supreme Court, on July 16, 1996, ruled that based upon these constitutional claims, the state had an affirmative obligation to provide Connecticut\u27s school children with a substantially equal educational opportunity. This constitutionally guaranteed right encompasses the access to a public education which is not substantially and materially impaired by racial and ethnic isolation. The Court further concluded that school districting based upon town and city boundary lines are unconstitutional. The implications and potential ramifications of this decision are significant. This dissertation chronicles the events and examines the issues surrounding this landmark decision. The background contributing to the plaintiffs claims, the state\u27s position, the historical evolution of the case, and reaction/actions and proposals to remedy and comply with the court\u27s order are examined

Transcatheter aortic valve implantation in patients with pre-existing chronic kidney disease

We investigated the effect of chronic kidney disease (CKD) on morbidity and mortality following transcatheter aortic valve implantation (TAVI) including patients on haemodialysis, often excluded from randomised trials. We performed a retrospective post hoc analysis of all patients undergoing TAVI at our centre between 2008 and 2012. 118 consecutive patients underwent TAVI, 63 were considered as having (CKD) and 55 not having (No-CKD) significant pre-existing CKD, (defined as estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2). Chronic haemodialysis patients (n = 4) were excluded from acute kidney injury (AKI) analysis. Following TAVI, in CKD and No-CKD patients respectively, AKI occurred in 23.7% and 14.5% (p = 0.455) and renal replacement therapy (RRT) was necessary in 8.5% and 3.6% (relative risk (RR) [95% CI] = 2.33 [0.47–11.5], p = 0.440), 30-day mortality rates were 6.3% and 1.8% (p = 0.370), and 1-year mortality rates were 17.5% and 18.2% (p = 0.919). Patients who developed AKI had a significantly increased risk of 30-day (12.5% vs. 1.1%, p = 0.029) mortality. We found the presence of diabetes (odds ratio (OR) [95% CI] = 4.58 [1.58–13.3], p = 0.005) and elevated baseline serum creatinine (OR [95% CI] = 1.02 [1.00–1.03], p = 0.026) to independently predict AKI to statistical significance by multivariate analysis. TAVI is a safe, acceptable treatment for patients with pre-existing CKD, however caution must be exercised, particularly in patients with pre-existing diabetes mellitus and elevated pre-operative serum creatinine levels as this confers a greater risk of AKI development, which is associated with increased short-term post-operative mortality