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Background: There is a little evidence regarding long-term safety and efficacy for atrial shunt devices in heart failure (HF)., Methods: The REDUCE LAP-HF I (n = 44) and II (n = 621) trials (RCT-I and -II) were multicenter, randomized, sham-controlled trials of patients with HF and ejection fraction >40%. Outcome data were analyzed from RCT-I, a mechanistic trial with 5-year follow-up, and RCT-II, a pivotal trial identifying a responder group (n = 313) defined by exercise PVR <1.74 WU and no cardiac rhythm management device with 3-year follow-up., Results: At 5 years in RCT I, there were no differences in cardiovascular (CV) mortality, HF events, embolic stroke, or new-onset atrial fibrillation between groups. After 3 years in RCT II, there was no difference in the primary outcome (hierarchical composite of CV mortality, stroke, HF events, and KCCQ) between shunt and sham in the overall trial. Compared to sham, those with responder characteristics in RCT-II had a better outcome with shunt (win ratio 1.6 [95% CI 1.2-2.2], P = .006; 44% reduction in HF events [shunt 9 vs. control 16 per 100 patient-years], P = .005; and greater improvement in KCCQ overall summary score [+17.9 ± 20.0 vs. +7.6 ± 20.4], P < .001), while nonresponders had significantly more HF events. Shunt treatment at 3 years was associated with a higher rate of ischemic stroke (3.2% vs. 0%, 95% CI 2%-6.1%, P = .032) and lower incidence of worsening kidney dysfunction (10.7% vs. 19.3%, P = .041)., Conclusions: With up to 5 years of follow up, adverse events were low in patients receiving atrial shunts. In the responder group, atrial shunt treatment was associated with a significantly lower HF event rate and improved KCCQ compared to sham through 3 years of follow-up., Gov Registration: NCT02600234, NCT03088033., Competing Interests: Conflict of Interest None., (Published by Elsevier Inc.)

Background: Severe yew (Taxus) intoxication is a rare condition that can lead to life-threatening cardiac arrhythmia. The survival of patients requires highly specialized emergency and intensive care treatment., Objectives: Systematic overview of the clinical picture and important treatment options., Methods: Case report of severe yew intoxication with subsequent literature review of comparable case reports. Analysis of 33 case reports with a total of 37 critically intoxicated patients from the years 2000-2024 from Europe and North America., Results: Severe yew intoxications were almost exclusively the result of suicidal intent. Patients average age was 33 (± 14.5) years. The use of antiarrhythmic drugs and electrical stimulation of the heart often proved to be ineffective or deteriorating in its effect over time. The use of lipid emulsion and/or digoxin-specific Fab fragments has little evidence. The average duration of a clinically relevant arrhythmogenic effect was 22±11.7 h., Conclusions: The management of yew intoxication is primarily limited to symptomatic treatment. The availability of venoarterial extracorporeal membrane oxygenation (VA-ECMO) in a "bridge-to-recovery" concept appears to be of utmost importance., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Importance: Patients with atrial fibrillation (AF) who have ischemic stroke despite taking oral anticoagulation therapy (OAT) have a very high risk of recurrence. Left atrial appendage occlusion (LAAO) is a mechanical stroke prevention strategy that may provide additional protection in patients with thromboembolic events under OAT., Objective: To compare percutaneous LAAO with continuing OAT alone regarding stroke prevention in patients with AF who had a thromboembolic event despite taking OAT., Design, Setting, and Participants: This cohort study was a propensity score-matched comparison of the STR-OAC LAAO cohort, an international collaboration of 21 sites combining patients from multiple prospective registries of patients who underwent LAAO between 2010 and 2022. STR-OAC LAAO cohort patients who had follow-up longer than 3 months were propensity score-matched to a previously published control cohort comprising patients from an established international collaboration of investigator-initiated prospective studies. This control cohort included patients with nonvalvular AF, recent ischemic stroke or transient ischemic attack, and follow-up longer than 3 months who were taking OAT before the index event. Analyses were adjusted for imbalances in gender, age, hypertension, diabetes, and CHA2 DS2-VASc score., Exposure: Left atrial appendage occlusion vs continuation of oral anticoagulation therapy alone (control group)., Main Outcomes and Measures: The primary outcome was time to first ischemic stroke., Results: Four hundred thirty-three patients from the STR-OAC LAAO cohort (mean [SD] age, 72 [9] years; 171 [39%] females and 262 [61%] males; mean [SD] CHA2 DS2-VASc score, 5.0 [1.6]) were matched to 433 of 1140 patients (38%) from the control group. During 2-year follow-up, 50 patients experienced ischemic stroke: an annualized event rate of 2.8% per patient-year in the STR-OAC LAAO group vs 8.9% per patient-year in the control group. Left atrial appendage occlusion was associated with a lower risk of ischemic stroke (hazard ratio, 0.33; 95% CI, 0.19-0.58; P < .001) compared with the control group. After LAAO, OAT was discontinued in 290 patients (67%), and the remaining 143 patients (33%) continued OAT after LAAO as an adjunctive therapy., Conclusions and Relevance: In patients with nonvalvular AF and a prior thromboembolic event despite taking OAT, LAAO was associated with a lower risk of ischemic stroke compared with continued OAT alone. Randomized clinical trial data are needed to confirm that LAAO may be a promising treatment option for this population with a very high risk of stroke.

Aims: Sufficient survival time following left atrial appendage occlusion (LAAO) is essential for ensuring the efficacy and cost-effectiveness of this strategy for stroke prevention. Understanding prognostic factors for early mortality after LAAO could optimize patient selection. In the current study, we perform an in-depth analysis of 2-year mortality after LAAO, focusing particularly on potential predictors., Methods and Results: The EWOLUTION registry is a real-world cohort comprising 1020 patients that underwent LAAO. Endpoint definitions were pre-specified, and death was categorized as cardiovascular, non-cardiovascular, or unknown origin. Mortality rates were calculated from Kaplan-Meier estimates. Baseline characteristics significantly associated with death in univariate Cox regression analysis were incorporated into the multivariate analysis. All multivariate predictors were included in a risk model. Two-year mortality rate was 16.4% [confidence interval (CI): 14.0-18.7%], with 50% of patients dying from a non-cardiovascular cause. Multivariate baseline predictors of 2-year mortality included age [hazard ratio (HR) 1.05, CI: 1.03-1.08, per year increase], heart failure (HR 1.73, CI: 1.24-2.41), vascular disease (HR 1.47, CI: 1.05-2.05), valvular disease (HR 1.63, CI: 1.15-2.33), abnormal liver function (HR 1.80, CI: 1.02-3.17), and abnormal renal function (HR 1.58, CI: 1.10-2.27). Mortality rate exhibited a gradual rise as the number of risk factors increased, reaching 46.1% in patients presenting with five or six risk factors., Conclusion: One in six patients died within 2 years after LAAO. We identified six independent predictors of mortality. When combined, this model showed a gradual increase in mortality rate with a growing number of risk factors, which may guide appropriate patient selection for LAAO., Clinical Trial Registration: The original EWOLUTION registry was registered at clinicaltrials.gov under identifier NCT01972282., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Left atrial appendage occlusion (LAAO) provides mechanical cardioembolic protection for atrial fibrillation (AF) patients who cannot use oral anticoagulation therapy (OAT). Patients with a thrombotic event despite OAT are at high risk for recurrence and may also benefit from LAAO., Objectives: This study sought to investigate the efficacy of LAAO in AF patients with a thrombotic event on OAT compared to: 1) LAAO in AF patients with a contraindication for OAT; and 2) historical data., Methods: The international LAAO after stroke despite oral anticoagulation (STR-OAC LAAO) collaboration included patients who underwent LAAO because of thrombotic events on OAT. This cohort underwent propensity score matching and was compared to the EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) registry, which represents patients who underwent LAAO because of OAT contraindications. The primary outcome was ischemic stroke. Event rates were compared between cohorts and with historical data without OAT, yielding relative risk reductions based on risk scores., Results: Analysis of 438 matched pairs revealed no significant difference in the ischemic stroke rate between the STR-OAC LAAO and EWOLUTION cohorts (2.5% vs 1.9%; HR: 1.37; 95% CI: 0.72-2.61). STR-OAC LAAO patients exhibited a higher thromboembolic risk (HR: 1.71; 95% CI: 1.04-2.83) but lower bleeding risk (HR: 0.39; 95% CI: 0.18-0.88) compared to EWOLUTION patients. The mortality rate was slightly higher in EWOLUTION (4.3% vs 6.9%; log-rank P = 0.028). Relative risk reductions for ischemic stroke were 70% and 78% in STR-OAC LAAO and EWOLUTION, respectively, compared to historical data without OAT., Conclusions: LAAO in patients with a thrombotic event on OAT demonstrated comparable stroke rates to the OAT contraindicated population in EWOLUTION. The thromboembolic event rate was higher and the bleeding rate lower, reflecting the intrinsically different risk profile of both populations. Until randomized trials are available, LAAO may be considered in patients with an ischemic event on OAT., Competing Interests: Funding Support and Author Disclosures Dr Maarse has received an educational grant from Boston Scientific. Dr Tondo serves on the advisory board of Boston Scientific; and has received lecture and tutoring fees from Boston Scientific and Abbott Medical. Dr Demkow has received proctoring fees from Boston Scientific and Abbott. Dr de Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Nielsen-Kudsk has received grants from Abbott and Boston Scientific. Dr Estevez-Loureiro is a proctor for Abbott Vascular, Boston Scientific, and Lifetech. Dr de Prado is a proctor for Boston Scientific. Dr Nombela-Franco is a proctor for Abbott Vascular, Edwards Lifesciences, and Boston Scientific. Dr Salinas is a proctor for Abbott Vascular. Dr Berti is a proctor for Edwards Lifesciences, Boston Scientific, and Abbott. Dr Millan has received consultant fees/honoraria from Abbott Laboratories and Boston Scientific. Dr Arzamendi has received consultant fees/honoraria from Abbott Laboratories and Boston Scientific. Dr Agarwal is a member of the Speaker Bureau and proctor for Medtronics, Abbott, Edwards Lifesciences, and Boston Scientific. Dr Spoon is a speaker for Medtronic, Abiomed, and Abbott. Dr El-Chami is a consultant for Medtronic and Boston Scientific. Dr Adamo has received speaker honoraria from Abbott Structural Heart. Dr van Dijk is a proctor for Boston Scientific. Dr Swaans is a proctor/lecturer for Abbott Vacular, Bioventrix Inc, Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, GE Healthcare, and Philips Healthcare. Dr Vireca is an employee of Boston Scientific. Dr Bergmann has received speaker honoraria from Boston Scientific and Abbott; and has received research support from Boston Scientific and Abbott. Dr Boersma is a consultant for Boston Scientific; and is a proctor for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)