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Background: Despite major advances, transcatheter aortic valve replacement (TAVR) is still associated with procedure‐specific complications. Although previous studies reported lower bleeding rates in patients receiving protamine for heparin reversal, the optimal protamine‐to‐heparin dosing ratio is unknown. Hypothesis: The aim of this study was a comparison of two different heparin antagonization regimens for the prevention of bleeding complications after TAVR. Methods: The study included 1446 patients undergoing TAVR, of whom 623 received partial and 823 full heparin antagonization. The primary endpoint was a composite of 30‐day mortality, life‐threatening, and major bleeding. Safety endpoints included stroke and myocardial infarction at 30 days. Results: Full antagonization of heparin resulted in lower rates of the primary endpoint as compared to partial heparin reversal (5.6% vs. 10.4%, p <.01), which was mainly driven by lower rates of life‐threatening (0.5% vs. 1.6%, p =.05) and major bleeding (3.2% vs. 7.5%, p <.01). Moreover, the incidence of major vascular complications was significantly lower in patients with full heparin reversal (3.5% vs. 7.5%, p <.01). The need for red‐blood‐cell transfusion was lower in patients receiving full as compared to partial heparin antagonization (10.4% vs. 15.9%, p <.01). No differences were observed in the incidence of stroke and myocardial infarction between patients with full and partial heparin reversal (2.2% vs. 2.6%, p =.73 and 0.2% vs. 0.4%, p =.64, respectively). Conclusions: Full heparin antagonization resulted in significantly lower rates of life‐threatening and major bleeding after TAVR as compared to partial heparin reversal. The occurrence of stroke and myocardial infarction was low and comparable between both groups. [ABSTRACT FROM AUTHOR]

Objective: To investigate the rate and clinical impact of a persisting iatrogenic atrial septal defect (iASD) after percutaneous left atrial appendage occlusion (LAAO). Background: Percutaneous LAAO is an alternative to oral anticoagulation (OAC) for the prevention of ischemic stroke and systemic embolism in patients with atrial fibrillation (AF). Data regarding incidence and persistence of iASD after LAAO procedures and its clinical relevance is scarce. Methods: We retrospectively analyzed 144 patients that underwent LAAO at our center between 2009 and 2020 who had at least one follow‐up including transesophageal echocardiography (TEE). Baseline clinical, procedural data and echocardiographic characteristics in patients with and without evidence of an iASD were compared. We furthermore determined the rate of iASD persistence over time and evaluated outcomes of patients with and without spontaneous iASD closure. Results: After a median of 92 days (IQR 75–108 days) after LAAO, 50 patients (50/144, 34.7%) showed evidence of an iASD. Patients with iASD had higher CHADS‐VASc‐scores (4.9±1.5 vs 4.2±1.2, p = 0.03), larger left atrial volumes (80.5±30.5 ml vs 67.1±19.7 ml, p = 0.01) and were more likely to have relevant mitral regurgitation (≥° II) (46.0% vs 12.3%, p = 0.001). LAAO procedures took longer (50.1±24.3 vs 41.1±17.8 min, p = 0.06) in patients with a persisting iASD. Furthermore, larger device sizes were implanted (24.3±3.4 mm vs 22.1±2.8 mm, p = 0.03). The presence of an iASD had no impact on RV dysfunction, thromboembolism or mortality. Spontaneous closure of an iASD was documented in 52.0% (26/50). Hereby, similar risk factors were identified for the persistence of an iASD in follow‐up. [ABSTRACT FROM AUTHOR]

Background: Malnutrition is a hallmark of frailty, is common among elderly patients, and is a predictor of poor outcomes in patients with severe symptomatic aortic stenosis (AS). The Geriatric Nutritional Risk Index (GNRI) is a simple and well‐established screening tool to predict the risk of morbidity and mortality in elderly patients. In this study, we evaluated whether GNRI may be used in the risk stratification and management of patients undergoing transcatheter aortic valve replacement (TAVR). Methods: Patients with symptomatic severe AS (n = 953) who underwent transfemoral TAVR at the University Hospital Schleswig‐Holstein Kiel, Germany, between 2010 and 2019 (development cohort) were divided into two groups: normal GNRI ≥ 98 (no nutrition‐related risk; n = 618) versus low GNRI < 98 (at nutrition‐related risk; n = 335). The results were validated in an independent (validation) cohort from another high‐volume TAVR centre (n = 977). Results: The low‐GNRI group had a higher proportion of female patients (59.1% vs. 52.1%), higher median age (82.9 vs. 81.8 years), prevalence of atrial fibrillation (50.4% vs. 40.0%), median logistic EuroSCORE (17.5% vs. 15.0%) and impaired left ventricular function (<35%: 10.7% vs. 6.8%), lower median estimated glomerular filtration rate (50 vs. 57 mL/min/1.73 m2) and median albumin level (3.5 vs. 4.0 g/dL) compared with the normal‐GNRI group. Among peri‐procedural complications, Acute Kidney Injury Network (AKIN) Stage 3 was more common in the low‐GNRI group (3.6% vs. 0.6%, p = 0.002). After a mean follow‐up of 21.1 months, all‐cause mortality was significantly increased in the low‐GNRI group compared with the normal‐GNRI group (p < 0.001). This was confirmed in the validation cohort (p < 0.001). Low GNRI < 98 was identified as an independent risk factor for all‐cause mortality (hazard ratio 1.44, 95% CI 1.01–2.04, p = 0.043). Other independent risk factors included albumin level < median of 4.0 g/dL, high‐sensitive troponin T in the highest quartile (> 45.0 pg/mL), N‐terminal pro‐B‐type natriuretic peptide in the highest quartile (> 3595 pg/mL), grade III–IV tricuspid regurgitation, pulmonary arterial hypertension, life‐threatening bleeding, AKIN Stage 3 and disabling stroke. Conclusions: Low GNRI score was associated with an increased risk of all‐cause mortality in patients undergoing TAVR, implying that this vulnerable group may benefit from improved preventive measures. [ABSTRACT FROM AUTHOR]

Summary: Background: Heart rate variability (HRV) is reduced in cirrhosis and in conditions of systemic inflammation. Whether HRV is associated with cirrhosis decompensation and development of acute‐on‐chronic liver failure (ACLF) is unknown. Aims: To (a) validate wireless remote HRV monitoring in cirrhosis decompensation; (b) determine if severely reduced HRV is a surrogate for inflammation and progression of cirrhosis decompensation; (c) assess if measuring HRV determines prognosis in cirrhosis decompensation. Methods: One hundred and eleven patients at risk of cirrhosis decompensation at two clinical sites were monitored for HRV. Standard deviation of all normal beat‐beat intervals (SDNN) reflecting HRV was assessed using remote monitoring (Isansys Lifetouch) and/or Holter ECG recording. Clinical outcomes and major prognostic scores were recorded during 90‐day follow‐up. Results: Reduced HRV denoted by lower baseline SDNN, correlated with severity of decompensation (median 14 (IQR 11‐23) vs 33 (25‐42); P < 0.001, decompensated patients vs stable outpatient cirrhosis). Furthermore, SDNN was significantly lower in patients developing ACLF compared to those with only decompensation (median 10 (IQR9‐12) vs 16 (11‐24); P = 0.02), and correlated inversely with MELD and Child‐Pugh scores, and C‐reactive protein (all P < 0.0001) and white cell count (P < 0.001). SDNN predicted disease progression on repeat measures and appeared an independent predictor of 90‐day mortality (12 patients). An SDNN cut‐off of 13.25 ms had a 98% negative predictive value. Conclusions: This study demonstrates that remote wireless HRV monitoring identifies cirrhosis patients at high risk of developing ACLF and death, and suggests such monitoring might guide the need for early intervention in such patients. Clinical Trial number: NIHR clinical research network CPMS ID 4949. [ABSTRACT FROM AUTHOR]

Endoluminal left atrial appendage occlusion is an emerging therapy to treat patients suffering from atrial fibrillation with contraindications against oral anticoagulation. Different occlusion devices have been introduced into the clinical setting while comparative studies between the devices are sparse. This in vitro study compares several endoluminal left atrial appendage occlusion systems regarding 2 mechanical properties: radial (RF) and tug force (TF). Seven different occluder systems of various sizes (24 in total) underwent testing throughout their recommended sizing range. RF was measured in a commercial RF tester. TF was assessed according to a recently published bench test. RF increased with compression of the devices: The LAmbre 2228 device exerted the highest RF (8.6 N) at maximum compression of 16 mm. The lowest RF of 0.1 N was exhibited by the 27 mm Occlutech occluder at minimal compression. The highest TFs were exerted by the WaveCrest devices at maximum compression with 4.6 and 3.6 N for the 22 mm and the 27 mm device, respectively. The lowest TFs were measured for the first‐generation Occlutech devices, particularly for the 24 mm device with 1.1 N at maximum compression and 0.4 N at minimum compression. A strong positive correlation was found between the number of hooks per millimeter circumference of an occluder and its tug force (r = 0.87, P < 0.01). The analysis revealed device stability to be more dependent on anchoring structures than on RF. The wide range of mechanical properties makes comparison of current LAA occluders difficult and emphasizes the need for standardized preclinical testing to prompt clinical compatibility. [ABSTRACT FROM AUTHOR]

Introduction. Left atrial appendage closure (LAAC) is considered an alternative to oral anticoagulation therapy in patients with atrial fibrillation (AF). The aim of this study was to compare the safety and efficacy of the first- and second-generation AMPLATZER Devices for LAAC, AMPLATZER Cardiac Plug (ACP) versus AMPLATZER Amulet™. Methods. Procedural data, such as fluoroscopy time, radiation dose, and contrast-dye, as well as VARC criteria and major adverse events (MAEs) were assessed for both devices. The rate of peridevice leaks was analyzed at echocardiographic follow-up. Results. A total of 196 patients with AF underwent LAAC with the ACP (n=99) or Amulet device (n=97). The use of Amulet was associated with significantly lower fluoroscopy time (14.8 ± 7.4 min versus 10.6 ± 4.1 min; p<0.001), lower radiation dose (4833 ± 3360 cGy⁎cm2 versus 3206 ± 2169 cGy⁎cm2; p<0.001), and reduced amount of contrast-dye (150.2 ± 83.9 ml versus 128.8 ± 46.0 ml; p=0.03). Furthermore, LAAC with Amulet devices resulted in lower device-resizing rates (3 versus 16 cases; p=0.001). Peridevice leaks were less frequent in the Amulet group (12 versus 4; p=0.03). MAE occurred in 6 ACP and 4 Amulet patients (p=0.58). Conclusions. The Amulet device is associated with shorter fluoroscopy times and radiation dosages, reduced use of contrast-dye, lower recapture rates, and less peridevice leaks as compared to the ACP. [ABSTRACT FROM AUTHOR]