Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the FRANCE-TAVI Registry.

BACKGROUND: No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has been conducted to date. METHODS: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality. RESULTS: In propensity-matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% CI, 1.46-1.91]; P<0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 [95% CI, 1.63-2.22]; P<0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 [95% CI, 1.07-1.66]; P=0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 [95% CI, 1.06-1.29]; P=0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis. CONCLUSION: The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov. Unique identifier: NCT01777828.

Early Evaluation of Patients on Axial Flow Pump Support for Refractory Cardiogenic Shock is Associated with Left Ventricular Recovery.

We investigated prognostic factors associated with refractory left ventricle (LV) failure leading to LV assist device (LVAD), heart transplant or death in patients on an axial flow pump support for cardiogenic shock (CS). Sixty-two CS patients with an Impella® CP or 5.0 implant were retrospectively enrolled, and clinical, biological, echocardiographic, coronarographic and management data were collected. They were compared according to the 30-day outcome. Patients were mainly male (n = 55, 89%), 58 ± 11 years old and most had no history of heart failure or coronary artery disease (70%). The main etiology of CS was acute coronary syndrome (n = 57, 92%). They presented with severe LV failure (LV ejection fraction (LVEF) 22 ± 9%), organ malperfusion (lactate 3.1 ± 2.1 mmol/L), and frequent use of inotropes, vasopressors, and mechanical ventilation (59, 66 and 30%, respectively). At 24 h, non-recovery was associated with higher total bilirubin (odds ratios (OR) 1.07 (1.00-1.14); p = 0.039), lower LVEF (OR 0.89 (0.81-0.96); p = 0.006) and the number of administrated amines (OR 4.31 (1.30-14.30); p = 0.016). Early evaluation in patients with CS with an axial flow pump implant may enable the identification of factors associated with an unlikely recovery and would call for early screening for LVAD or heart transplant.

Aortic and innominate routes for transcatheter aortic valve implantation.

OBJECTIVES: This study aimed at evaluating the efficacy and safety of the transaortic approach for the transcatheter aortic valve implantation procedure using balloon-expandable and self-expanding devices. METHODS: From January 2012 to December 2016, the transaortic-transcatheter aortic valve implantation procedure was performed in 206 consecutive patients at the Rangueil University Hospital. All procedures were performed by a multidisciplinary heart team. The ascending aorta (27%) or innominate artery (73%) was exposed through a J-type manubriotomy. Events were adjudicated according to Valve Academic Research Consortium-2 criteria. RESULTS: Mean age and logistic European System for Cardiac Risk Evaluation II were 83.9 ± 6.7 years and 16.8% ± 10.8%, respectively. Balloon-expandable and self-expanding valves were implanted in 59.7% and 40.3% of patients, respectively. Device success rate was 98.1%. Thirty-day overall mortality, cardiovascular mortality, cerebrovascular event, myocardial infarction, and permanent pacemaker implantation rates were 5.3%, 4.4%, 1.5%, 1.0%, and 9.7%, respectively (1-year rates: 15.5%, 9.2%, 3.9%, 3.4%, and 10.2%, respectively). Life-threatening bleeding and major vascular complications (7.3% and 3.9%, respectively) were not related to the central access site in approximately half of the cases. Multivariable Cox regression analysis identified preoperative renal failure as an independent predictor of overall mortality (odds ratio, 2.82; 95% confidence interval, 1.73-4.59; P < .0001). At the 1-year follow-up, most patients had experienced improved functional status and 98.4% of them were free of moderate to severe paravalvular leak. CONCLUSIONS: In a higher-risk subgroup within the patient population receiving transcatheter aortic valve implantation, transaortic-transcatheter aortic valve implantation was successfully performed in 98.1% of cases, with high functional improvement and low rates of mortality and adverse events, especially neurologic complications.

Appropriate secondary prevention and clinical outcomes after acute myocardial infarction according to atherothrombotic risk stratification: The FAST-MI 2010 registry.

BACKGROUND: Full secondary prevention medication regimen is often under-prescribed after acute myocardial infarction. DESIGN: The purpose of this study was to analyse the relationship between prescription of appropriate secondary prevention treatment at discharge and long-term clinical outcomes according to risk level defined by the Thrombolysis In Myocardial Infarction (TIMI) Risk Score for Secondary Prevention (TRS-2P) after acute myocardial infarction. METHODS: We used data from the 2010 French Registry of Acute ST-Elevation or non-ST-elevation Myocardial Infarction (FAST-MI) registry, including 4169 consecutive acute myocardial infarction patients admitted to cardiac intensive care units in France. Level of risk was stratified in three groups using the TRS-2P score: group 1 (low-risk; TRS-2P=0/1); group 2 (intermediate-risk; TRS-2P=2); and group 3 (high-risk; TRS-2P≥3). Appropriate secondary prevention treatment was defined according to the latest guidelines (dual antiplatelet therapy and moderate/high dose statins for all; new-P2Y12 inhibitors, angiotensin-converting-enzyme inhibitor/angiotensin-receptor-blockers and beta-blockers as indicated). RESULTS: Prevalence of groups 1, 2 and 3 was 46%, 25% and 29% respectively. Appropriate secondary prevention treatment at discharge was used in 39.5%, 37% and 28% of each group, respectively. After multivariate adjustment, evidence-based treatments at discharge were associated with lower rates of major adverse cardiovascular events (death, re-myocardial infarction or stroke) at five years especially in high-risk patients: hazard ratio = 0.82 (95% confidence interval: 0.59-1.12, p = 0.21) in group 1, 0.74 (0.54-1.01; p = 0.06) in group 2, and 0.64 (0.52-0.79, p < 0.001) in group 3. CONCLUSIONS: Use of appropriate secondary prevention treatment at discharge was inversely correlated with patient risk. The increased hazard related to lack of prescription of recommended medications was much larger in high-risk patients. Specific efforts should be directed at better prescription of recommended treatment, particularly in high-risk patients.

Drug-eluting or bare-metal stents in subjects over 75 years of age: what is the best therapeutic strategy? Data from 460 consecutive patients with 1-year outcome.

BACKGROUND: The use of stents has become common in subjects over 75 years of age, but choosing the best type of stent still remains difficult. Our objective was to compare safety and clinical benefits of drug-eluting stent (DES) and bare-metal stent (BMS) at 1 year in this population. METHODS: We included 460 consecutive patients aged 75 or over who had undergone angioplasty with DES (n=167) or BMS (n=293) between January 1 and December 31, 2005, and had 12-month clinical follow-up. RESULTS: At 12 months, the cumulative percentages of all-cause deaths, cardiac deaths, and major adverse cardiac event (cardiac death, myocardial infarction, or repeat revascularization) were higher in the BMS group (15.7% vs. 7.2%; P=.008; 11.3% vs 3.0%; P=.002; 15.7% vs 8.4%; P=.025). Major hemorrhages were not significantly different between the two groups (3.7% with BMS vs 3.6% with DES; P=.930). In multivariate survival analysis, the relative risk (RR) of death in the BMS group as compared to the DES group was 2.20 (95% confidence interval, 1.16-4.19; P=.016). However, the difference disappeared after exclusion of deaths that occurred during the first month (RR=1.33; 95% confidence interval, 0.63-2.82; P=.456) or when analysis was performed on patients matched according to a propensity score to be treated with BMS (RR=1.46; 95% confidence interval, 0.54-3.92; P=.453). CONCLUSION: Beyond the first month, DES implantation was associated in these patients over 75, with a 1-year risk of death that was not significantly different from the risk associated with the implantation of BMS. DES still should be preferred in indications currently recognized from a scientific standpoint.

Clinical and angiographic outcome of stenting of unprotected left main coronary artery bifurcation narrowing.

PURPOSE: Improvements in techniques and equipments may result in the wider applicability of percutaneous coronary intervention (PCI) for unprotected left main coronary artery (ULMCA) stenosis. This report is a prospective study focused on the feasibility, effectiveness and long-term results of stenting for treatment of ULMCA bifurcation lesions. METHODS: From November 2002 to October 2003, 57 consecutive patients were stented with bare metal stents and the technique of kissing balloon followed by T-provisional stenting was applied for ostial left anterior descending, left circumflex or distal left main coronary lesion. RESULTS: Mean age was 69.5+/-10.7 years. Acute coronary syndrome occurred in 68.4% of patients with a majority of two or three vessel disease (45.10% and 35.30% respectively). GpIIbIIIa inhibitors were used in only 5.8% of cases. Angiographic success was obtained in 100% of patients. Hospital stay was 7.03+/-2.26 days without major adverse cardiac events. At eight months follow-up, cardiac death was 1.7%, non-fatal myocardial infarction 5.1% and target vessel revascularisation 22.8% including CABG 15.7% and repeated PCI 10.5% with an angiographic restenosis rate of 29.8%. CONCLUSION: In the setting of coronary stenting of the ULMCA stenosis, the use of bare metal stents can no longer be considered contemporary technique and another strategy such as coated stent may be needed.