Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics and clinical outcomes over time are limited. OBJECTIVES: The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period. METHODS: TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers. RESULTS: A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE]: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p < 0.001 for both). Stroke and potentially life-threatening complications, such as annulus rupture or aortic dissection, remained stable over time, whereas rates of cardiac tamponade and pacemaker implantation significantly increased. CONCLUSIONS: The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE TAVI]; NCT01777828).

Ischemic stroke associated with left cardiac catheterization: the importance of modifiable and non-modifiable risk factors.

BACKGROUND: Stroke associated with left cardiac catheterization is a devastating complication, and its incidence has not changed over the decades. We investigated the incidence, in-hospital outcomes and the modifiable and non-modifiable risk factors for periprocedural ischemic stroke. METHODS: Our retrospective cohort study included all patients experiencing periprocedural ischemic stroke among the 24,500 patients who underwent left cardiac catheterization between January 2003 and October 2010. The case group was compared with a group of control patients randomly selected among those who underwent the procedure during this period. RESULTS: Ischemic cerebrovascular events attested by brain imaging occurred in 37 patients (0.15% of procedures), transient ischemic attack occurred in 9 cases, and persistent neurological deficit occurred in 28 cases. Patients who developed strokes were more likely to be older and were more often female with a greater prevalence of comorbidities. Emergency and longer procedures were more frequent in patients in the case group who had more coronary complications. A multivariate analysis identified diabetes mellitus (adjusted odds ratio (OR) 4.2; 95% CI 1.8-9.9; P < .001), chronic renal dysfunction (OR 2.4; 95% CI 1.1-5.4; P < .001), known cerebrovascular disease (OR 5.1; 95% CI 2.3-11.5; P < .001), emergency procedure (OR 3.1; 95% CI 1.4-9.2; P < .01) and recent congestive heart failure (OR 6.1; 95% CI 2.9-13; P < .001) as independent predictors for stroke. The independent modifiable predictive factors were represented by left ventricular angiography (OR 7.5; 95% CI 2.7-21; P < .001), and low operator volume (OR 3.1; 95% CI 1.3-7.4; P < .01). CONCLUSION: Limiting the performance of left cardiac catheterization to high volume operators and avoiding unnecessary left ventricular angiography may reduce periprocedural ischemic stroke.

Prolonged intubation rates after coronary artery bypass surgery and ICU risk stratification score.

OBJECTIVE: To determine prolonged intubation rates among patients undergoing coronary artery bypass graft (CABG) surgery, and to evaluate the ability of the Intensive Care Unit Risk Stratification Score (ICURSS) model to predict these events. DESIGN: Prospective observational study. SETTING: A 24-bed ICU in a tertiary referral university hospital. PATIENTS: Five hundred sixty-nine patients undergoing CABG surgery. INTERVENTIONS: Variables of the ICURSS model were recorded at ICU admission. Extubation was performed according to a standard protocol. Patients remaining intubated within 8 h after ICU admission were designated as having early extubation failure (EEF). The next evaluations at 16, 24, 48, 72, and 96 h designated patients as having a prolonged intubation period (PIP) and prolonged mechanical ventilation (PMV) for 24, 48, 72, and 96 h. The ability of the ICURSS model to predict extubation failure at different cutoff values was measured using the Hosmer-Lemeshow goodness-of-fit test and the area under the receiver operating characteristic curve. MEASUREMENTS AND RESULTS: Prolonged intubation rates were as follows: EEF, 40.2%; PIP, 17.2%; PMV for 24 h, 10.4%; PMV for 48 h, 7.6%; PMV for 72 h, 6.5%; and PMV for 96 h, 6.0%. At every cutoff, the ICURSS showed poor discrimination to predict the failure to be extubated. Calibration was also poor, although some ability to predict both EEF and PMV at > or = 48 h was shown. CONCLUSIONS: Prolonged intubation rates after undergoing CABG surgery in our setting were comparable with those of other reports from institutions where fast-track cardiac anesthesia is currently in practice. In our cohort, the ICURSS was not useful for the prediction of length of intubation.