Mitral valve-in-valve and valve-in-ring procedures: Midterm outcomes in a French nationwide registry.

OBJECTIVES: Report contemporary outcomes in patients included in the Mitragister registry and treated with transcatheter mitral valve implantation for failed surgical annuloplasty rings or deteriorated bioprosthesis. BACKGROUND: Midterm survival rates have been reported, but little is known about contemporary morbimortality endpoints. METHODS: The primary safety outcome was the technical success rate. The primary efficacy composite endpoint was a composite of cardiovascular mortality and heart failure hospitalizations. RESULTS: From 2016 to 2021, 102 patients (median age: 81 [74;84] years, 61% female, Euroscore II 11.0% [7.8;16.0]) undergoing valve-in-valve (ViV; n = 89) or valve-in-ring (ViR; n = 13) procedures were consecutively included. At baseline, ViR group patients had worse left ventricular ejection fraction (50% vs. 60%; p = 0.004) and more frequently severe regurgitation (46% vs. 15%; p = 0.014). The primary safety outcome was 95%: 77% and 98% in the ViR and ViV populations, respectively, (p = 0.014). At intermediate follow-up (6-12 months) clinical improvement was notable, 88% of the patients were in NYHA class ≤ II (vs. 25% at baseline; p < 0.001). At a mean follow-up of 17.1 ± 11.0 months, the primary efficacy composite reached 27%. By multivariate analysis, paravalvular leak (PVL) was the only independent predictor (hazard ratio: 2.39, 95% confidence interval: 1.08-5.29; p = 0.031) while ViR was not found statistically associated (p = 0.456). CONCLUSIONS: This study confirms the safety and efficacy of the mitral ViV procedure. ViR patients appear at higher risk of procedural complications. The presence of PVL could be associated with markedly worse midterm prognosis. Whatever the intervention, procedural strategies to reduce PVL incidence remain to be assessed to prevent latter adverse outcomes.

Current treatment of symptomatic aortic stenosis in elderly patients: Do risk scores really matter after 80 years of age?

BACKGROUND: According to the guidelines, surgical aortic valve replacement (SAVR) is recommended in patients at low surgical risk (EuroSCORE II<4%), whereas for other patients, the decision between transcatheter aortic valve implantation (TAVI) and surgery should be made by the Heart Team, with TAVI being favoured in elderly patients. AIM: The RAC prospective multicentre survey assessed the respective contributions of age and surgical risk scores in therapeutic decision making in elderly patients with severe symptomatic aortic stenosis. METHODS: In September and October 2016, 1049 consecutive patients aged ≥ 75 years were included in 32 centres with on-site TAVI and surgical facilities. The primary endpoint was the decision between medical management, TAVI or SAVR. RESULTS: Mean age was 84±5 years and 53% of patients were female. The surgical risk was classified as high (EuroSCORE II>8%) in 18% of patients, intermediate (EuroSCORE II 4-8%) in 34% and low (EuroSCORE II≤4%) in 48%. TAVI was preferred in 71% of patients, SAVR in 19% and medical treatment in 10%. The choice of TAVI over SAVR was associated with older age (P<0.0001) and a higher EuroSCORE II (P=0.008). However, the weight of EuroSCORE II in therapeutic decision making markedly decreased after the age of 80 years. Indeed, 77% of patients aged ≥ 80 years were referred for TAVI, despite a low estimated surgical risk. CONCLUSIONS: The impact of risk scores depends strongly on age, and decreases considerably after 80 years, most patients being referred for TAVI, independent of their estimated surgical risk. Despite medical advancements, 10% of patients were still denied any intervention.

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).

Incident Myocardial Infarction and Very Late Stent Thrombosis in Outpatients With Stable Coronary Artery Disease.

BACKGROUND: Current data are lacking for incidence, correlates, and prognosis associated with incident myocardial infarction (MI) in patients with stable coronary artery disease (CAD). Furthermore, the contribution of very late stent thrombosis (VLST) to these events remains poorly understood. OBJECTIVES: This study aimed to analyze the residual risk of MI, together with relevant associated factors, and related mortality in stable CAD outpatients. METHODS: The multicenter CORONOR (Suivi d'une cohorte de patients COROnariens stables en region NORd-Pas-de-Calais) study enrolled 4,184 unselected outpatients with stable CAD (i.e., MI or coronary revascularization >1 year previously). Five-year follow-up was achieved for 4,094 patients (98%). RESULTS: We identified a linear risk of incident MI (0.8% annually), with ST-segment elevation MI constituting one-third of all cases. Current smoking, low-density lipoprotein cholesterol, multivessel CAD, diabetes with glycosylated hemoglobin >7%, and persistent angina were all associated with increased risk, and prior bypass surgery was associated with decreased risk. When used as a time-dependent variable, incident MI was associated with an increased risk of death (hazard ratio: 2.05; p < 0.0001). Among patients with prior stent implantation, VLST was causal in 20% of MI cases and presented more often as ST-segment elevation MI versus MI not related to a stented site (59% vs. 26%, p = 0.001). Adjusted mortality was 4 times higher in patients with VLST than in MI not related to a stented site. CONCLUSIONS: In stable CAD outpatients, incident MI occurs at a stable rate of 0.8% annually, is related to VLST in one-fifth of cases, and is associated with an increased mortality risk, especially for VLST. Multivessel CAD and residual uncontrolled risk factors are strongly associated with MI.

Dual antiplatelet therapy in patients with stable coronary artery disease in modern practice: prevalence, correlates, and impact on prognosis (from the Suivi d'une cohorte de patients COROnariens stables en region NORd-Pas-de-Calais study).

BACKGROUND: The prevalence and correlates of dual-antiplatelet therapy (DAPT) use in stable coronary artery disease (CAD) are unknown. In addition, whether prolonged DAPT may impact prognosis in stable CAD has not been studied in real-life conditions. METHODS: We studied 3,691 patients included in a prospective registry on stable CAD. The patients were divided in 2 groups according to their antiplatelet therapy regimen at inclusion: patients treated with DAPT were compared with those treated with single-antiplatelet therapy (SAPT). The primary outcome was a composite of cardiovascular death, myocardial infarction, or stroke. RESULTS: Altogether, 868 (24%) patients received DAPT. Factors positively associated with DAPT use were persistent angina at inclusion, body mass index, myocardial infarction since 1 to 3 years, myocardial revascularization since 1 to 3 years, multivessel CAD, prior drug-eluting stent implantation, and prior aortic or peripheral intervention. Factors negatively associated with DAPT use were age, prior coronary bypass, and left ventricular ejection fraction. The rate of the primary outcome at 2 years was similar whether patients were treated with SAPT (4.6%) or DAPT (5.5%) (P = .301). Similar rates were also observed after propensity score matching: 5.7% when treated with SAPT versus 5.5% when treated with DAPT (P = .886). The rate of bleeding was similar between groups. CONCLUSIONS: Our study shows that a significant proportion of stable CAD patients are treated with DAPT in modern practice. Several correlates of DAPT were identified. Although no increase in bleeding was observed, our results do not support the prescription of prolonged DAPT.