Clinical outcomes of patients undergoing percutaneous left atrial appendage occlusion in general anaesthesia or conscious sedation: data from the prospective global Amplatzer Amulet Occluder Observational Study

Objective To evaluate the safety and efficacy of percutaneous left atrial appendage occlusion (LAAO) using conscious sedation (CS).Background Several percutaneous structural heart disease interventions are safely and efficiently performed using CS instead of general anaesthesia (GA). This concept has not been evaluated in a large multicenter cohort of patients undergoing LAAO.Methods Patients from the prospective, global Amplatzer Amulet Occluder Observational Study were divided into two groups (GA vs CS). Baseline information, periprocedural and postprocedural efficacy and complications, as well as outcomes through 7 days post implant were compared.Results Patients undergoing transesophageal-guided implants were categorised by GA (n=607, 64%) or CS (n=342, 36%) usage. Mean age was 75 years in both groups. LAAO technical success was achieved in 99% of both groups. The procedure duration (GA: 35 +/- 22 min vs CS: 27 +/- 19 min, pConclusions In a large global study, LAAO with the Amplatzer Amulet occluder is safe and feasible using CS. Procedure duration and total amount of contrast were less with CS than GA cases.</p

Length of stay following percutaneous left atrial appendage occlusion: Data from the prospective, multicenter Amplatzer Amulet Occluder Observational Study

Aims To evaluate factors influencing the length of stay in patients undergoing percutaneous left atrial appendage occlusion (LAAO). Methods and results Patient characteristics, procedural data and the occurrence of serious adverse events were analyzed from the Amplatzer Amulet Occluder Observational Study. Patients were divided into three groups: same day (S, 0day, n = 60, 5.6%) early (E, 1day, n = 526, 48.9%), regular (R, 2-3days, n = 338, 31.4%) and late (L, >= 4days, n = 152, 14.1%) discharge and followed up for 60 days. Procedure and device related SAE during the in-hospital stay (S: 0.0% vs. E: 1.0% vs. R: 2.1% vs. L: 23%, pConclusion Over half of the subjects receiving an Amplatzer Amulet occluder were discharged within 1 day of the implant procedure. Serious adverse events were a major trigger for a late discharge after LAAO. Increased HAS-BLED score was associated with a prolonged in-hospital stay.</p

Clinical and echocardiographic risk factors for device-related thrombus after left atrial appendage closure: an analysis from the multicenter EUROC-DRT registry

BACKGROUND Data on Device-related Thrombus (DRT) after left atrial appendage closure (LAAC) remain scarce. This study aimed to investigate risk factors for DRT from centers reporting to the EUROC-DRT registry. METHODS We included 537 patients (112 with DRT and 425 without DRT) who had undergone LAAC between 12/2008 and 04/2019. Baseline and implantation characteristics, anti-thrombotic treatment and clinical outcomes were compared between both groups in uni- and multivariate analyses. Additional propensity-score matching (PSM) was conducted to focus on the role of implantation characteristics. RESULTS Patients with DRT showed higher rates of previous stroke/transient ischemic attack (TIA) (49.1% vs. 34.7%, p < 0.01), spontaneous echocardiographic contrast (SEC) (44.9% vs. 27.7%, p < 0.01) and lower left atrial appendage (LAA) peak emptying velocity (35.4 ± 18.5 vs. 42.4 ± 18.0 cm/s, p = 0.02). Occluders implanted in DRT patients were larger (25.5 ± 3.8 vs. 24.6 ± 3.5 mm, p = 0.03) and implanted deeper in the LAA (mean depth: 7.6 ± 4.7 vs. 5.7 ± 4.7 mm, p < 0.01). Coverage of the appendage ostium was achieved less often in DRT patients (69.5% vs. 81.5%, p < 0.01), while DRT patients were less frequently on oral anticoagulation (7.1% vs. 16.7%, p < 0.01). Multivariate analysis identified age, prior stroke/TIA and SEC as independent risk factors for DRT. After PSM, implantation depth was found to be predictive. Rates of stroke/TIA were higher in DRT patients (13.5% vs. 3.8%, Hazard Ratio: 4.21 [95%-confidence interval: 1.88-9.49], p < 0.01). CONCLUSIONS DRT after LAAC is associated with adverse outcome and appears to be of multifactorial origin, depending on patient characteristics, anticoagulation regimen and device position

Acute stroke intervention for acute embolic procedural strokes performed by cardiologists

Acute ischemic stroke is a feared complication during cardiovascular procedures associated with high morbidity and mortality if not immediately recognized and treated. We conducted a review of cases at our center where patients experienced an acute, procedure-related ischemic stroke and underwent immediate endovascular stroke treatment by the interventional cardiologists trained in acute endovascular stroke intervention. Baseline demographics, procedural and follow-up data were collected. Three patients were identified in whom the percutaneous procedure (peripheral arterial intervention, transapical NeoChord [NeoChord Inc, Minnesota, USA] implantation and transcatheter aortic valve implantation, respectively) was complicated by an acute embolic ischemic stroke. In all cases, cerebral vessel re-canalization was technically successful with thrombolysis in cerebral infarction (TICI) IIB/III flow. Follow-up computed tomography scans showed no infarct demarcation, oedema or intracranial hemorrhage. One patient survived with no neurological symptoms at 6-month follow-up whereas the two other patients died of unrelated intensive care complications and decompensated heart failure. We conclude that endovascular stroke treatment during cardiovascular interventions can be performed by interventional cardiologists with appropriate training. It offers the unique opportunity to treat cerebral embolization in a time-efficient manner, potentially improving morbidity and mortality of affected patients

Haemoglobin levels as a predictor for the occurrence of future cardiovascular events in adults–Sex-dependent results from the EPIC trial

Background: The impact of hemoglobin levels on the occurrence of future health events remains equivocal. Due to its integral role in human hemostasis, both, high and low hemoglobin levels may play a significant role in the development of future cardiovascular (CV) events in otherwise healthy adults. Methods: Data from the European Prospective Investigation into Cancer (EPIC)-InterAct cohort was analyzed. In 13.648 individuals, physical activity, body mass index, family history of cardiovascular events, kidney function, smoking status, blood pressure and LDL levels were modelled to concomitant hemoglobin levels and correlated to the occurrence of clinically-overt cardiovascular events and death over a 21-year period. (Sex specific) cox regression analysis were used to develop hazard ratios (HRs) for CV events and all-cause mortality. Results: Anemia (hemoglobin (HGB) levels < 13.0 g/dl in men and < 12.0 g/dl in non-pregnant women) were associated with an increased all-cause mortality in men but not in women (HR anemia in men 1.4 (1.2; 1.6)) p=<0.0001).This was particularly visible with increasing age. Various sex specific Cox regression models, accounting for several CV risk factors confirmed these results. The incidence of future CV events and myocardial infarction was significantly influenced by underlying HGB levels in men with increasing age but not in women. Conclusion: The influence of HGB levels on future cardiovascular events is sex-dependent. In men, presenting with anemia at baseline, the overall survival probability was impaired with increasing age. After adjusting for several CV risk factors, abnormal hemoglobin levels could be identified as a risk factor for the development of clinically-apparent future CV events in men. None of these effects were observed in women

Predictors of calcification distribution in severe tricuspid aortic valve stenosis

We investigated aortic valve calcification (AVC) distribution and predictors for leaflet calcification patterns in patients with severe tricuspid aortic valve stenosis undergoing transcatheter aortic valve replacement (TAVR). Patients undergoing routine multi-sliced computed tomography (MSCT) for procedural planning were enrolled. MSCT data were transferred to a dedicated workstation for evaluation (3mensio Structural Heart™, Pie Medical Imaging BV, Maastricht, The Netherlands) and analyzed. Participants were separated into asymmetrical (AC) and symmetrical (SC) leaflet calcification and potential predictors for calcification distribution were identified with univariate and multivariate regression analysis. 567 Participants with severe tricuspid AS were divided into asymmetrical (AC, n = 443; 78.1%) and symmetrical (SC, n = 124; 21.9%) AVC. In AC, the non-coronary cusp was the most calcified cusp (n = 238; 57.7%). SC is more common in females (AC/SC: 49.2% vs. 67.7%; p &amp;lt; 0.0001). AVC was more severe in patients with AC, who also have larger aortic root dimensions. Multivariate analysis depicted, inter alia, left ventricular outflow tract (LVOT) calcification &amp;lt; 25 Agatston units (OR 1.81 [1.09-3.00], p = 0.021), a mean pressure gradient &amp;lt; 36 mmHg (OR 1.77 [1.03-3.05], p = 0.039), and an annulo-apical angle &amp;gt; 67° (OR 1.68 [1.00-2.80], p = 0.049) as predictors for SC, although with only moderate predictive value. Data from this retrospective analysis indicate that SC occurs more frequently in females. The cumulative leaflet calcification burden is higher in patients with AC, who also present with larger aortic root dimensions. The predictive value for prominent calcification of different aortic valve cusps in AC patients was only low to moderate.Trial registration number: NCT01805739