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Abstract Background While prior Micra trials demonstrated a high implant success rate and favorable safety and efficacy results, changes in implant populations and safety over time is not well studied. The objective of this analysis was to report the performance of Micra in European and Middle Eastern patients and compare to the Micra Investigational Device Exemption (IDE) and Micra Post Approval Registry (PAR) studies. Methods The prospective, single‐arm Micra Acute Performance European and Middle Eastern (MAP EMEA) registry was designed to further study the performance of Micra in patients from EMEA. The primary endpoint was to characterize acute (30‐day) major complications. Electrical performance was analyzed. The major complication rate through 12 months was compared with the IDE and PAR studies. Results The MAP EMEA cohort (n = 928 patients) had an implant success rate of 99.9% and were followed for an average of 9.7 ± 6.5 months. Compared to prior studies, MAP EMEA patients were more likely to have undergone dialysis and have a condition which precluded the use of a transvenous pacemaker (p

Abstract Aims Cardiac resynchronization therapy (CRT) is highly effective in dilated cardiomyopathy (DCM) patients with impaired left ventricular ejection fraction (LVEF) and left bundle block branch. In cardiac amyloidosis (CA) patients, left ventricular dysfunction and conduction defects are common, but the potential of CRT to improve cardiac remodelling and survival in this particular setting remains undefined. We investigated cardiovascular outcomes in CA patients after CRT implantation in terms of CRT echocardiographic response and major cardiovascular events (MACEs). Methods and results Our retrospective study included 47 CA patients implanted with CRT devices from January 2012 to February 2020, in nine French university hospitals (77 ± 6 years old, baseline LVEF 30 ± 8%) compared with propensity‐matched (1:1 for age, LVEF at implantation, and CRT indication) DCM patients with a CRT device. CA patients had lower rates of CRT response (absolute delta LVEF ≥ 10%) compared with DCM patients (36% vs. 70%, P = 0.002). After multivariate Cox analysis, CA was independently associated with MACE (hospitalization for heart failure/cardiovascular death) [hazard ratio (HR) 3.73, 95% confidence interval (CI) 1.85–7.54, P

Background Leadless ventricular permanent pacemakers (leadless VVI or LPM) were designed to reduce lead‐related complications of conventional VVI pacemakers (CPM). The aim of our study was to assess and compare real‐life clinical outcomes within the first 30 days and during a midterm follow‐up with the 2 techniques. Methods and Results This French longitudinal cohort study was based on the national hospitalization database. All adults (age ≥18 years) hospitalized in French hospitals from January 1, 2017 to September 1, 2020, who underwent a first LPM or CPM were included. The study included 40 828 patients with CPM and 1487 with LPM. After propensity score matching 1344 patients with CPM were matched 1:1 with patients treated with LPM. Patients with LPM had a lower rate of all‐cause and cardiovascular death within the 30 days after implantation. During subsequent follow‐up (mean: 8.6±10.5 months), risk of all‐cause death in the unmatched population was significantly higher in the LPM group than in the CPM group, whereas risk of cardiovascular death and of endocarditis was not significantly different. After matching on all baseline characteristics including comorbidities (mean follow‐up 6.2±8.7 months), all‐cause death, cardiovascular death, and infective endocarditis were not statistically different in the 2 groups. Conclusions Patients treated with leadless VVI pacemakers had better clinical outcomes in the first month compared with the patients treated with conventional VVI pacing. During a midterm follow‐up, risk of all‐cause death, cardiovascular death, and endocarditis in patients treated with leadless VVI pacemaker was not statistically different after propensity score matching.

Background The incidence of conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with early and later generation prostheses remains debated. Methods and Results Based on the administrative hospital‐discharge database, we collected information for all patients treated with TAVR between 2010 and 2019 in France. We compared the incidence of PPI after TAVR according to the type and generation of valve implanted. A total of 49 201 patients with aortic stenosis treated with TAVR using the balloon‐expandable (BE) Edwards SAPIEN valve (early Sapien XT and latest Sapien 3) or the self‐expanding (SE) Medtronic CoreValve (early CoreValve and latest Evolut R) were found in the database. Mean (SD) follow‐up was 1.2 (1.5 years) (median [interquartile range] 0.6 [0.1–2.0] years). PPI after the procedure was reported in 13 289 patients, among whom 11 010 (22.4%) had implantation during the first 30 days. In multivariable analysis, using early BE TAVR as reference, adjusted odds ratio (95% CI) for PPI during the first 30 days was 0.88 (0.81–0.95) for latest BE TAVR, 1.40 (1.27–1.55) for early SE TAVR, and 1.17 (1.07–1.27) for latest SE TAVR. Compared with early BE TAVR, the adjusted hazard ratio for PPI during the whole follow‐up was 1.01 (0.95–1.08) for latest BE TAVR, 1.30 (1.21–1.40) for early SE TAVR, and 1.25 (1.18–1.34) for latest SE TAVR. Conclusions In patients with aortic stenosis treated with TAVR, our systematic analysis at a nationwide level found higher rates of PPI than previously reported. BE technology was independently associated with lower incidence rates of PPI both at the acute and chronic phases than SE technology. Recent generations of TAVR were not independently associated with different rates of PPI than early generations during the overall follow‐up.

Abstract Background Cardiac resynchronization therapy (CRT) reduces symptoms, morbidity and mortality in chronic heart failure patients with wide QRS complexes. However, approximately one third of CRT patients are non-responders. Myocardial fibrosis is known to be associated with absence of response. We sought to see whether galectin-3, a promising biomarker involved in fibrosis processes, could predict response and outcomes after CRT. Methods Consecutive patients eligible for implantation of a CRT device with a typical left bundle branch block ≥ 120 ms were prospectively included. Serum Gal-3 level, Selvester ECG scoring, and cardiac magnetic resonance with analysis of late gadolinium enhancement (LGE) were ascertained. Response to CRT was defined by a composite endpoint at 6 months: no death, nor hospitalization for major cardiovascular event, and a significant decrease in left ventricular end-systolic volume of 15% or more. Results Sixty-one patients were included (age 61 ± 5 years, ejection fraction 27 ± 5%), 59% with non-ischemic cardiomyopathy. At 6 months, 49 patients (80%) were considered responders. Responders had a lower percentage of LGE (8 ± 13% vs 22 ± 16%, p = 0.006), and a trend towards lower rates of galectin-3 (16 ± 6 ng/mL vs 19 ± 8 ng/mL, p = 0.13). LGE ≥ 14% and Gal-3 ≥ 22 ng/mL independently predicted response to CRT (OR = 0.17 [0.03–0.62], p = 0.007, and OR = 0.11 [0.02–0.04], p

Background The efficacy of cardiac resynchronization therapy may be reduced in the event of pacing within myocardial fibrosis. We aimed to develop a method to determine the anatomical relationships between the left ventricular (LV) lead and myocardial fibrosis. Methods and Results In consecutive patients indicated for cardiac resynchronization therapy, cardiovascular magnetic resonance imaging with late gadolinium enhancement assessment was performed before implantation. After implantation, an injected computed tomography scanner (CT scan) was performed. The 2 imaging techniques were fused to assess the LV lead position relative to myocardial scar. A total of 68 patients were included. Myocardial scar was found in 29 (43%) and was localized in lateral segments in 14 (21%). Scar was significantly associated with male sex, ischemic cardiomyopathy, a Selvester score adapted to left bundle branch block (LBBB Selvester), and Selvester criteria for localizing lateral fibrosis (V2 S/S′ ratio). Image fusion was feasible in all patients. Position within myocardial scar was confirmed for 6 electrodes in 3 patients. Prolonged QRS duration during LV pacing ≥139% predicted electrode positioning within scar tissue (sensitivity, 83%; specificity, 91%; P=0.002). Conclusions In cardiac resynchronization therapy patients, fusion between preimplantation cardiovascular magnetic resonance and a postimplantation injected computed tomography scan is a feasible technique. Prolongation of the QRS duration during LV pacing predicts pacing within myocardial scar. Accurate location of LV lead pacing electrodes on the epicardial surface relative to myocardial scar, either by imaging or ECG analyses, may help improve cardiac resynchronization therapy response in selected patients.

INTRODUCTION:Mechanisms of maintenance of both atrial fibrillation and structural left ventricular disease are known to include fibrosis. Galectin-3, a biomarker of fibrosis, is elevated both in patients with heart failure and persistent atrial fibrillation. We sought to find whether galectin-3 has a prognostic value in patients with heart failure and a reduced left ventricular ejection fraction undergoing ablation of persistent atrial fibrillation. METHODS:Serum concentrations of galectin-3 were determined in a consecutive series of patients with an ejection fraction ≤40%, addressed for ablation of persistent atrial fibrillation. Responders to ablation were patients in sinus rhythm and with an ejection fraction ≥50% at 6 months. A combined endpoint of heart failure hospitalization, transplantation and/or death was used at 12 months. RESULTS:Seventy-five patients were included (81% male, age 63±10 years, ejection fraction 34±7%, galectin-3 21±12 ng/mL). During follow-up, eight patients were hospitalized for decompensated heart failure, 1 underwent heart transplantation, and 4 died; 50 patients were considered as responders to ablation. After adjustment, galectin-3 level independently predicted both 6-month absence of response to ablation (OR = 0.89 per unit increase, p = 0.002). Patients with galectin-3 levels

Abstract Background Although less common, typical atrial flutter shares similar pathophysiological roots with atrial fibrillation. Following successful cavo‐tricuspid isthmus ablation using radiofrequency, many patients, however, develop atrial fibrillation in the mid‐to‐long‐term. This study sought to assess whether pulmonary vein isolation conducted at the same time as cavo‐tricuspid isthmus ablation would significantly modify the atrial fibrillation burden upon follow‐up in patients suffering from typical atrial flutter. Methods This was a multicenter randomized controlled study involving typical atrial flutter patients with history of non‐predominant atrial fibrillation (1 atrial fibrillation episode only, in 67% of population) who were scheduled for cavo‐tricuspid isthmus radiofrequency ablation. Patients were randomly assigned to either undergo cavo‐tricuspid isthmus ablation alone or cavo‐tricuspid isthmus plus pulmonary vein isolation (CTI+). Pulmonary vein isolation was performed using cryoballoon technology. An outpatient consultation with ECG and 1‐week Holter monitoring was performed at 3, 6 months, 1 year, and 2 years postprocedure. The primary endpoint was atrial fibrillation recurrences lasting more than 30 s at 2 years postablation. Results Of the patients enrolled, 36 were included in each group. At 2‐year follow‐up, the atrial fibrillation recurrence rate was significantly higher in the CTI vs CTI+group (25/36, 69% vs. 12/36, 33% respectively; P