Assessment of Long-Term Structural Deterioration of Transcatheter Aortic Bioprosthetic Valves Using the New European Definition.

BACKGROUND: The durability of transcatheter aortic bioprosthetic valves is a crucial issue, but data are scarce, especially beyond 5 years of follow-up. We aimed to assess long-term (7 years) structural valve deterioration (SVD) and bioprosthetic valve failure of transcatheter aortic bioprosthetic valves. METHODS AND RESULTS: Consecutive patients with at least 5-year follow-up available undergoing transcatheter aortic valve implantation from April 2002 to December 2011 in 5 French centers were included. Incidence of SVD and bioprosthetic valve failure were defined according to newly standardized criteria of the European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery and reported as cumulative incidence function to account for the competing risk of death. One thousand four hundred three consecutive patients were included with a mean age of 82.6±7.5 years and with a mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) of 21.3±7.5%. A balloon-expandable valve was used in 83.7% of cases. Survival rates were 83.5% (95% CI, 81.4%-85.5%) and 18.6% (95% CI, 15.3%-21.8%) at 1 and 7 years, respectively. Median duration of follow-up was 3.9 years. Bioprosthetic valve failure occurred in 19 patients with a 7-year cumulative incidence of 1.9% (95% CI, 1.4%-2.4%). SVD occurred in 49 patients (moderate, n=32; severe, n=17) with a 7-year cumulative incidence of moderate and severe SVD of 7.0% (95% CI, 5.6%-8.4%) and 4.2% (95% CI, 2.9%-5.5%), respectively. Five patients had aortic valve reintervention (1.0%; 95% CI, 0.4%-1.6%) including 1 case of surgical aortic valve replacement and 4 redo-transcatheter aortic valve implantation. The incidences of SVD and bioprosthetic valve failure were not significantly different between balloon and self-expandable prostheses. CONCLUSIONS: The long-term assessment of transcatheter aortic bioprosthetic valves durability is limited by the poor survival of our population beyond 5 years. Further studies are warranted, particularly in younger and lower-risk patients.

Impact of gender on use of revascularization in acute coronary syndromes: the national observational study of diagnostic and interventional cardiac catheterization (ONACI).

OBJECTIVES: To assess the impact of gender on myocardial revascularization using data collected in a French nationwide registry: the national observational study of diagnostic and interventional cardiac catheterization (ONACI). BACKGROUND: Gender differences in management of patients with acute coronary syndromes (ACS) have been reported. METHODS: We analysed data from a nationwide French prospective multicentre registry including 64,932 suspected ACS patients recruited in 99 centres from 2004 to 2008. RESULTS: Overall, women were older (70.7 ± 12.7 vs. 63.8 ± 12.9 years), had a higher cardiovascular risk profile, and were more frequently admitted with non ST-elevation myocardial infarction or unstable angina (NSTEMI/UA) compared to men (73% vs. 68%). Women had significantly more angiographically normal coronary arteries or non-significant coronary artery disease (CAD) in both STEMI (6% vs. 3%) and NSTEMI/UA (21% vs. 11%) while men had more severe CAD. After adjusting for age, cardiovascular risk factors, and extent of disease, myocardial revascularization (defined as the use of percutaneous coronary intervention (PCI) or coronary artery bypass grafting) was less frequently used in women (adjusted OR = 0.78; 95% CI: 0.77-0.83). For those receiving PCI, in-hospital mortality within 24 hr of intervention was higher in women (3.6% vs. 1.2%; adjusted OR = 1.51; 95% CI: 1.22-1.87). CONCLUSIONS: In the present study, despite having a higher cardiovascular risk profile, women more frequently had normal vessel/non-significant angiographic coronary artery disease. In patients with significant coronary artery disease, myocardial revascularization was less frequently used in women whatever the type of ACS.

Cost of transcatheter aortic valve implantation and factors associated with higher hospital stay cost in patients of the FRANCE (FRench Aortic National CoreValve and Edwards) registry.

BACKGROUND: Currently, several anatomical approaches and intervention sites can be used to perform transcatheter aortic valve implantations (TAVIs), often with no clinical indications for choosing one or another. While these choices can have an impact on resource consumption, no costing study is available in the European context to provide information on resource use and assist decision-making. AIMS: To provide comparative data on the cost of the TAVI procedure, depending on anatomical approach and intervention site used, from a hospital perspective, and to analyze factors associated with cost of hospital stay. METHODS: Multicentre national registry data were collected in 16 centres between January and October 2009. For 287 patients, a descriptive costing study and a multivariable analysis of hospital stay cost were performed. RESULTS: The mean cost of the TAVI procedure was €22,876 and the mean initial hospital stay cost was €35,164. The procedure cost, excluding valve cost, did not differ between anatomical approaches and was highest in the hybrid room and lowest in the catheterization laboratory. Factors associated with higher hospital stay cost were transapical approach, Society of Thoracic Surgeons score>10%, warfarin use at inclusion, complications during procedure and pacemaker implantation following valve implantation. CONCLUSIONS: If clinical considerations do not interfere, hospital staff may find it economically favorable to opt for the catheterization laboratory and against the hybrid room. The mean hospital stay cost is higher than the tariff paid in 2011, a difference that has grown since the change in tariff in 2012, representing an economic disincentive for the uptake of TAVI in France.