Permanent pacemaker implantation after transcatheter aortic valve implantation: impact on late clinical outcomes and left ventricular function.

BACKGROUND: Very few data exist on the clinical impact of permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation. The objective of this study was to assess the impact of PPI after transcatheter aortic valve implantation on late outcomes in a large cohort of patients. METHODS AND RESULTS: A total of 1556 consecutive patients without prior PPI undergoing transcatheter aortic valve implantation were included. Of them, 239 patients (15.4%) required a PPI within the first 30 days after transcatheter aortic valve implantation. At a mean follow-up of 22±17 months, no association was observed between the need for 30-day PPI and all-cause mortality (hazard ratio, 0.98; 95% confidence interval, 0.74-1.30; P=0.871), cardiovascular mortality (hazard ratio, 0.81; 95% confidence interval, 0.56-1.17; P=0.270), and all-cause mortality or rehospitalization for heart failure (hazard ratio, 1.00; 95% confidence interval, 0.77-1.30; P=0.980). A lower rate of unexpected (sudden or unknown) death was observed in patients with PPI (hazard ratio, 0.31; 95% confidence interval, 0.11-0.85; P=0.023). Patients with new PPI showed a poorer evolution of left ventricular ejection fraction over time (P=0.017), and new PPI was an independent predictor of left ventricular ejection fraction decrease at the 6- to 12-month follow-up (estimated coefficient, -2.26; 95% confidence interval, -4.07 to -0.44; P=0.013; R(2)=0.121). CONCLUSIONS: The need for PPI was a frequent complication of transcatheter aortic valve implantation, but it was not associated with any increase in overall or cardiovascular death or rehospitalization for heart failure after a mean follow-up of ≈2 years. Indeed, 30-day PPI was a protective factor for the occurrence of unexpected (sudden or unknown) death. However, new PPI did have a negative effect on left ventricular function over time.

Percutaneous Mitral Valve Repair: Outcome Improvement with Operator Experience and a Second-Generation Device.

BACKGROUND AND AIM: Recent randomized data comparing percutaneous mitral valve repair (PMVR) versus optimal medical treatment in patients with functional MR (FMR) seemed to highlight the importance of the learning curve not only for procedural outcomes but also for patient selection. The aim of the study was to compare a contemporary series of patients undergoing PMVR using a second-generation Mitraclip device (Mitraclip NT) with previous cohorts treated with a first-generation system. METHODS: This multicenter study collected individual data from 18 centers between 2012 and 2017. The cohort was divided into three groups according to the use of the first-generation Mitraclip during the first (control-1) or second half (control-2) or the Mitraclip NT system. RESULTS: A total of 545 consecutive patients were included in the study. Among all, 182 (33.3%), 183 (33.3%), and 180 (33.3%) patients underwent mitral repair in the control-1, control-2, and NT cohorts, respectively. Procedural success was achieved in 93.3% of patients without differences between groups. Major adverse events did not statistically differ among groups, but there was a higher rate of pericardial effusion in the control-1 group (4.3%, 0.6%, and 2.6%, respectively; p = 0.025). The composite endpoint of death, surgery, and admission for congestive heart failure (CHF) at 12 months was lower in the NT group (23.5% in control-1, 22.5% in control-2, and 8.3% in the NT group; p = 0.032). CONCLUSIONS: The present paper shows that contemporary clinical outcomes of patients undergoing PMVR with the Mitraclip system have improved over time.

High-risk diabetic patients with unprotected left main coronary artery disease: characteristics and medium-term outcomes of percutaneous revascularization with drug-eluting stents.

Percutaneous coronary intervention with drug-eluting stents is an alternative for patients with high-risk unprotected left main coronary artery disease; those with diabetes mellitus are at even higher risk. Recent advances in percutaneous coronary intervention could lead to better results. The aim of this study was to evaluate medium-term results in a real-world sample of high-risk diabetic patients undergoing percutaneous coronary intervention with drug-eluting stents for unprotected left main coronary artery disease.From 3 tertiary hospitals, we retrospectively identified 334 high-risk patients, of whom 141 (42%) were diabetic and 193 (58%) were nondiabetic. The diabetes mellitus group showed a higher prevalence of peripheral vascular disease and left ventricular dysfunction. Angiographic and procedural characteristics did not differ significantly, with the exception of poor distal vessels in the diabetes mellitus group (44.5% vs 28.5%, P = 0.006). The use of intra-aortic balloon pumping and intravascular ultrasonography was low in both diabetic and nondiabetic patients. After a median follow-up of 22.4 months, cardiac death was higher in the diabetes mellitus group (16.2% vs 7.5%, P = 0.015), especially in insulin-dependent diabetic patients (25.8%). The incidence of major adverse cardiac events, including cardiac death, target-lesion revascularization, and myocardial infarction was similar in both groups (23.8% vs 18.3%, P = NS).High-risk diabetic patients who undergo percutaneous coronary intervention with drug-eluting stents for unprotected left main coronary artery disease present with a worse clinical profile that carries a higher cardiac mortality rate in the medium term, especially in insulin-dependent diabetic patients.