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Background: Coronary artery disease (CAD) is common in patients undergoing transcatheter aortic valve replacement (TAVR). However, the impact of CAD distribution before TAVR on short- and long-term prognosis remains unclear., Hypothesis: We hypothesized that the long-term clinical impact differs according to CAD distribution in patients undergoing TAVR using the FRench Aortic National CoreValve and Edwards (FRANCE-2) registry., Methods: FRANCE-2 is a national French registry including all consecutive TAVR performed between 2010 and 2012 in 34 centers. Three-year mortality was assessed in relation to CAD status. CAD was defined as at least 1 coronary stenosis >50%., Results: A total of 4201 patients were enrolled in the registry. For the present analysis, we excluded patients with a history of coronary artery bypass. CAD was reported in 1252 patients (30%). Half of the patients presented with coronary multivessel disease. CAD extent was associated with an increase in cardiovascular risk profile and in logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (from 19.3% ± 12.8% to 21.9% ± 13.5%, P < 0.001). Mortality at 30 days and 3 years was 9% and 44%, respectively, in the overall population. In multivariate analyses, neither the presence nor the extent of CAD was associated with mortality at 3 years (presence of CAD, hazard ratio [HR]: 0.90; 95% confidence interval [CI]: 0.78-1.07). A significant lesion of the left anterior descending (LAD) was associated with higher 3-year mortality (HR: 1.42; 95% CI: 1.10-1.87)., Conclusions: CAD is not associated with decreased short- and long-term survival in patients undergoing TAVR. The potential deleterious effect of LAD disease on long-term survival and the need for revascularization before or at the time of TAVR should be validated in a randomized control trial., (© 2017 Wiley Periodicals, Inc.)

Background: The development of new onset atrial fibrillation (NOAF) post-transcatheter aortic valve implantation (TAVI) is common and may be associated with an adverse prognosis. This study seeks to identify incidence, predictors, and impact of NOAF post-TAVI., Methods: From the multicenter study of the French national transcatheter aortic valve implantation registry, FRANCE 2, a total of 1959 patients with sinus rhythm prior to TAVI were enrolled into this study. The incidence of post-TAVI NOAF, predictors of development of NOAF and impact on 30-day and 1-year-mortalities were assessed., Results: Of the 1959 TAVI patients (mean-age: 82.6 ± 7.5 years, mean-logistic-EuroSCORE: 21.8 ± 14.3), 149 (7.6%) developed NOAF with the remaining 1810 (92.4%) control patients demonstrating no evidence of AF as defined by the Valve Academic Research Consortium (VARC). Advanced age and major and life-threatening bleeding were independent predictors of NOAF (95% CI: 0.93-0.99; p=0.006, 95% CI: 1.58-4.00; p<0.001, 95% CI: 1.09-3.75; p=0.025, respectively). A trend towards a higher incidence of major and life-threatening bleeding was observed in the patients undergoing TAVI via the transapical (TA)-approach compared with the transfemoral (TF)-approach. Both 30-day and cumulative 1-year-mortalities were significantly higher in patients with NOAF compared to patients without NOAF (3.0% vs. 7.4%; p=0.005, 9.1% vs. 20.8%; p<0.001, respectively). In addition, NOAF was an independent predictor of 30-day and 1-year-mortalities (HR: 2.16; 95% CI: 1.06-4.41; p=0.033, HR: 2.12; 95% CI: 1.42-3.15; p<0.001, respectively)., Conclusion: Advanced age and major and life-threatening bleeding were independently associated with increased incidence of NOAF, which itself was an independent predictor of 30-day and 1-year-mortalities. With regards to the various transcatheter approaches, a trend towards a higher incidence of major and life-threatening bleeding was observed only with the TA-approach., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Previous coronary artery bypass grafting (CABG) increases operative risk in conventional valve replacement. Transcatheter aortic valve implantation (TAVI) has been shown to be successful in high-risk patient subgroups. The present study compared outcome and overall survival in patients who underwent TAVI with and without history of CABG. From January 2010 to December 2011, 683 of the 3,761 patients selected for TAVI in 34 French centers (18%) had a history of CABG. Outcomes (mortality and complications) were collected prospectively according to the Valve Academic Research Consortium (VARC) criteria. Patients with previous CABG were younger, with higher rates of diabetes and vascular disease and higher logistic European System for Cardiac Operative Risk Evaluation (29.8 ± 16.4 vs 20.1 ± 13.0, p <0.001) but lower rates of pulmonary disease. Two types of valve (Edwards SAPIEN and Medtronic CoreValve) were implanted in equal proportions in the 2 groups. The 30-day and 1-year mortality rates from all causes on Kaplan-Meier analysis (9.2% vs 9.7%, p = 0.71; and 19.0% vs 20.2%, p = 0.49, respectively) did not differ according to the history of CABG. There were no significant differences in the Valve Academic Research Consortium complications (myocardial infarction, stroke or vascular, and bleeding complications). On multivariate analysis, CABG was not associated with greater 1-year post-TAVI mortality. In conclusion, previous CABG did not adversely affect outcome in patients who underwent TAVI, which may be an alternative to surgery in high-risk patients with severe aortic stenosis and history of CABG., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Analysis of the causes, outcomes, and mortality of patients with severe symptomatic aortic stenosis requiring the implantation of 2 valves during transcatheter aortic valve implantation was conducted from the French Aortic National CoreValve and Edwards 2 (FRANCE2) registry. Pre- and postprocedural data from 3,919 patients from January 2010 to December 2011 (CoreValve or Edwards) were collated and analyzed. Characteristics of patients requiring immediate second valve procedures were compared with those of the other patients. The 72 patients (1.8%) who underwent implantation of a second valve were studied. Indications were device malpositioning (72%) and embolization (28%). Clinical and echocardiographic characteristics of patients receiving 2 valves were comparable with those of the other patients. The 2-year survival rate was 51.7% for patients with 2 valves as opposed to 62.3% for those with 1 valve (p<0.001). The need for a second valve was an independent predictor of all-cause (hazard ratio 2.32, 95% confidence interval 1.50 to 3.60, p<0.001) and cardiovascular (hazard ratio 2.64, 95% confidence interval 1.35 to 5.15, p<0.001) mortality at 2 years. During follow-up, clinical and echocardiographic data remained similar between the 2 groups. In conclusion, in the FRANCE2 study, the main causes for second valve implantation during the same procedure were malpositioning and embolization. Although the procedure was feasible, it was accompanied by excess mortality. Valve hemodynamic status was preserved during the course of follow-up., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: The prognostic value of previous pulmonary oedema (PO) has not been thoroughly investigated in a large-cohort of TAVI-patients. The aim of this study was to assess the influence of previous clinical history of acute PO in severe aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI)., Methods: Data were analyzed for 3195 patients enrolled in the French national TAVI registry, FRANCE 2. We compared the clinical outcome of enrolled patients divided broadly into three groups according to the frequency of previous acute PO episode; group 1: no-episode, group 2: single-episode, and group 3: multiple-episodes within the year preceding TAVI., Results: Of the 3195 patients (mean age: 82.7 ± 7.2 years, mean logistic-EuroSCORE: 21.8 ± 14.3) with TAVI, 1880 (58.8%) had no-episode, 937 (29.3%) had single-episode, and 378 (11.9%) had multiple-episode. Both 30-day and cumulative 1-year mortality increased significantly across the 3 groups (7.7% vs. 9.2% vs. 15.9%; p<0.001, 14.0% vs. 19.4% vs. 24.1%; p<0.001, respectively). In addition, single-PO was not independently associated with an increased mortality at 30-day and 1-year compared to no-PO (HR: 0.99; 95% CI: 0.75-1.30; p=0.923, HR: 1.15; 95% CI: 0.94-1.39; p=0.173, respectively). In contrast multiple-PO was independently associated with an increased risk of both 30-day and cumulative 1-year mortality (HR: 1.51; 95% CI: 1.10-2.01; p=0.012, HR: 1.30; 95% CI: 1.01-1.66; p=0.043, respectively)., Conclusion: Multiple-PO, but not single, within the year preceding the index procedure is independently associated with increased mortality at short- and mid-term follow up after TAVI., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Aims: The aim of this study was to assess the influence of chronic kidney disease (CKD) classification on clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI)., Methods and Results: Data of 2,929 consecutive patients undergoing TAVI in the FRANCE 2 registry were analysed. Patients were divided into five groups: CKD 1+2, 3a, 3b, 4, and 5. Both 30-day and one-year mortality rates were significantly increased and positively correlated with CKD severity in all groups. After adjusting for significant influential confounders in a Cox regression multivariate model, CKD 4 and 5 were associated with increased risk of both 30-day mortality and one-year mortality when compared with CKD 1+2 as the reference. This higher mortality was predominantly driven by renal failure and infection in patients with CKD 4 and 5, respectively. Procedural success rate in CKD 5 was significantly lower than that in other groups. All CKD patients trended towards a higher incidence of acute kidney injury (AKI), in parallel with the degree of CKD severity., Conclusions: Classification of CKD stages before TAVI allows risk stratification for 30-day and one-year clinical outcomes. CKD 3b, 4 and 5 correlate with poor outcome and are considered a significant risk for TAVI.

Background: Transcatheter aortic valve implantation (TAVI) performed under local anesthesia (LA) is becoming increasingly common. We aimed to compare the clinical outcomes in patients who underwent transfemoral-TAVI under general anesthesia (GA) and LA., Methods and Results: Data from 2326 patients in the French Aortic National CoreValve and Edwards 2 (FRANCE 2) registry who underwent transfemoral-TAVI were analyzed. During the study period, the percentage of LA procedures increased gradually from 14% in January 2010 to 59% in October 2011. The clinical outcomes for GA (n=1377) and LA (n=949) were compared. Numerous baseline characteristics differed between the 2 groups, and the use of transesophageal echocardiographic guidance was more common in GA than in LA (76.3% versus 16.9%; P<0.001). Device success and cumulative 30-day survival rates were similar in the 2 groups (97.6% versus 97.0%; P=0.41 and 91.6% versus 91.3%; P=0.69, respectively), whereas the incidence of postprocedural aortic regurgitation≥mild was significantly lower in GA than in LA (15.0% versus 19.1%; P=0.015). The groups were also analyzed using a propensity-matching model, including transesophageal echocardiographic usage (GA [n=401] versus LA [n=401]). This model indicated that there were no significant differences between the 2 groups in the rates of 30-day survival (GA [91.4%] versus LA [89.3%]; P=0.27] and postprocedural aortic regurgitation≥mild (GA [12.7%] versus LA [16.2%]; P=0.19)., Conclusions: The less invasive transfemoral-TAVI under LA is preferred in clinical settings and seems to be acceptable; however, the higher incidence of postprocedural aortic regurgitation is emphasized. Therapeutic efforts should be made to reduce such complications during transfemoral-TAVI under LA., (© 2014 American Heart Association, Inc.)

Background: Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2., Methods: All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause., Results: A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women. All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%). The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively. At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%. In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival., Conclusions: This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option. (Funded by Edwards Lifesciences and Medtronic.).