Microvascular obstruction (MVO) is a phenomenon associated with worse outcome after acute myocardial infarction. While some studies suggested a benefit of an increased body mass index (BMI) in terms of MVO occurrence in ST-elevation myocardial infarction (STEMI), there are currently no data available on the influence of overweight on the development of MVO in Non-STEMI (NSTEMI). Thus, the aim of this study was to assess the association between MVO and BMI in NSTEMI patients. This study investigated a sub-cohort of the TATORT-NSTEMI trial. Overall, 354 patients were included with a median age of 68 years (25

AIMS:Right ventricular (RV) pacing may promote left ventricular (LV) dysfunction. Particularly in patients with preserved LV ejection fraction (LVEF), narrow QRS, and anticipated high ventricular pacing burden (HVPB), evidence is missing that biventricular (BiV) pacing can improve clinical outcome. We therefore evaluated whether implantation of a BiV pacing device (BiVPD) compared with a RV pacing device (RVPD) may improve clinical outcome in predominantly this kind of patients. METHODS AND RESULTS:In the Biventricular Pacing for atrioventricular Block to Prevent Cardiac Desynchronization (BioPace) trial [multicentre, single-blinded (patients), randomized, parallel group], patients were equally allocated to either receive a BiVPD or a RVPD. Co-primary endpoints were (i) the composite of time to death or first heart failure hospitalization and (ii) survival time. We analysed 1810 randomized patients (median age: 73.5 years; female sex: 31.7%; mean LVEF 55.4%; mean QRS 118.4 ms), 902 to BiV and 908 to RV pacing. During mean follow-up of 68.8 months, the difference in the primary composite endpoint between both groups [346 vs. 363 events, hazard ratio (HR) 0.878; 95% confidence interval (CI) 0.756-1.020; P = 0.0882) or in mortality (305 vs. 307 deaths, HR 0.926; 95% CI 0.789-1.088; P = 0.3492) was smaller than 20%. CONCLUSION:In patients, predominantly with preserved LVEF, narrow QRS, and HVPB, superiority of implanting BiVPDs compared with RVPDs could not be proven. Right ventricular pacing may be less harmful for this kind of patients than often suggested and primary BiV pacing does not clearly improve their clinical outcome. CLINICAL TRIAL REGISTRATION:Registered in ClinicalTrials.gov, number NCT00187278 (https://clinicaltrials.gov/ct2/show/study/NCT00187278).

BACKGROUND:Multivessel coronary artery disease (CAD) is present in 30% to 70% of patients presenting with non-ST-segment elevation myocardial infarction (NSTEMI) depending on varying age and risk profiles. In contrast to the STEMI cohort, there is only limited scientific evidence derived from randomized controlled trials directing the general decision for or against complete revascularization in the NSTEMI population. PRIMARY HYPOTHESIS:The COMPLETE-NSTEMI trial aims to investigate whether multivessel percutaneous coronary intervention (PCI) is superior over culprit-lesion only PCI in patients with NSTEMI and multivessel CAD. DESIGN:COMPLETE-NSTEMI is a prospective, randomized, controlled, multicenter, parallel group, open-label trial. It will enroll 3390 NSTEMI patients with multivessel CAD at 65 to 70 sites in Germany and Austria. Patients will be randomized 1:1 to either complete revascularization with PCI or culprit lesion-only PCI. ENDPOINTS:The primary efficacy endpoint is a composite of cardiovascular death or rehospitalization for nonfatal myocardial infarction during follow-up. The trial is event-driven and will be stopped as soon as 578 primary endpoint events and a minimal follow-up duration of 12 months for each patient are reached. CURRENT STATUS:The first patient was enrolled at October 27, 2023. By April 2025, 51 sites have been activated and >500 patients have been randomized. Completion of recruitment is expected for the first half of 2027. The final results of the primary endpoint are expected in 2028. OUTLOOK:COMPLETE NSTEMI will be the first dedicated trial to answer the question about the optimal revascularization strategy in patients with NSTEMI and multivessel CAD. TRIAL REGISTRATION:CLINICALTRIALS.GOV: NCT05786131.

BACKGROUND:Obesity is a known risk factor for cardiovascular disease (CVD), yet an 'obesity paradox' has been observed in various CVD contexts. The impact of obesity on heart failure (HF) patients treated with a wearable cardioverter-defibrillator (WCD) remains underexplored. METHODS:In a multicentre international registry, we retrospectively collected data from a consecutive series of 1003 patients. These patients were divided into three body mass index (BMI) groups: <25 kg/m2 (n = 348), 25-30 kg/m2 (n = 383), and >30 kg/m2 (n = 272), with BMI > 30 kg/m2 defined as the reference category. Demographics, indications, adherence, WCD shocks, arrhythmic events, rehospitalization due to cardiovascular causes, and mortality were analysed. RESULTS:At 3 month follow-up, patients with a BMI > 30 showed the greatest improvement in left ventricular ejection fraction (LVEF) at 51.4%, significantly higher than the 41.4% in those with a BMI < 25 (P = 0.017) and comparable with the 49.4% in the BMI 25-30 group (P = 0.635). WCD wearing time and adherence were similar across all BMI groups. The incidence of WCD shock was similar across BMI groups. Rates of ventricular tachycardia (VT), ventricular fibrillation and non-sustained VT (ns-VT) were comparable across BMI groups. The rate of implantable cardioverter-defibrillator (ICD) implantation was 40.3% across all patients, with a slightly lower rate in the BMI > 30 group (36.8%) compared with others, although not significantly. Rehospitalization due to cardiovascular causes was significantly lower in the BMI > 30 group (55.4%) compared with the BMI 25-30 group (70.9%; P = 0.048), but similar to the BMI < 25 group (54.9%; P = 0.957). At 2 year follow-up, mortality was lower in the BMI > 30 group (5.9%) compared with the BMI < 25 (7.5%; P = 0.029) and BMI 25-30 groups (7%; P = 0.681). In multivariable analysis, LVEF at long term was significantly associated with a reduction in mortality. CONCLUSIONS:Obese patients exhibited significantly greater improvement in LVEF, which was associated with reduced mortality. Adherence to WCD therapy was excellent across all BMI groups. ICD implantation occurred in 40.3% of patients, with similar WCD shock rates and arrhythmic events across BMI groups. An obesity paradox was observed, with obese patients demonstrating significantly lower rehospitalization rates due to cardiovascular causes and reduced mortality at follow-up.

BACKGROUND:Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. OBJECTIVES:We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. METHODS:Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. RESULTS:Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients. CONCLUSIONS:The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful. CONDENSED ABSTRACT:This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high.

Wearable cardioverter defibrillator (WCD) can protect patients from sudden cardiac death due to ventricular tachyarrhythmias and serve as a bridge to decision of definite defibrillator implantation. The aim of this analysis from an international, multicenter WCD registry was to identify predictors of sustained ventricular tachycardia (VT) and/or ventricular fibrillation (VF) in this population. One thousand six hundred seventy-five patients with WCD were included in a multicenter registry from 9 European centers, with a median follow-up of 440 days (IQR 120–893). The primary study end point was the occurrence of sustained VT/VF. Sustained VT was detected by WCD in 5.4

BackgroundData on the use of the wearable cardioverter defibrillator in patients suffering from inherited and congenital heart disease are limited. Consequently, evidence for guideline recommendations in this patient population is lacking.MethodsIn total 1,675 patients were included in a multicenter registry of eight European centers. In the present cohort, we included 18 patients suffering from congenital and inherited heart disease.ResultsNine patients (50%) were male with a mean age of 41.3 ± 16.4 years. Four patients suffered from hypertrophic cardiomyopathy (HCM), four patients suffered from non-compaction cardiomyopathy (NCCM), two patients were diagnosed with arrhythmogenic right ventricular cardiomyopathy (ARVC) and one patient suffered from muscular dystrophy of the limb-girdle type with cardiac involvement, secondary cardiomyopathy. Three patients presented with Brugada syndrome (BrS). One patient suffered from long-QT syndrome type 1 (LQTS1). Furthermore, two patients had congenital heart defects and one patient suffered from cardiac sarcoidosis (CS). There were no appropriate/inappropriate shocks with the WCD in this cohort. One patient had recurrent self-limiting sustained ventricular tachycardia during the wear time, but actively inhibited a shock and was hospitalized. The compliance rate in this cohort was 77.8% with a mean wear time of 45.3 ± 26.9 days with a mean follow-up time of 570 ± 734 days. 55.6% (10/18) of the patients received an ICD after WCD wear time.ConclusionsThis retrospective study of patients with inherited and congenital heart disease shows that WCD use is not beneficial in the majority of patients with inherited and congenital heart disease.

BACKGROUND:Wearable cardioverter defibrillators (WCD) are used as a 'bridging' technology in patients, who are temporarily at high risk for sudden cardiac death (SCD). Several factors should be taken into consideration, for example patient selection, compliance and optimal drug treatment, when WCD is prescribed. We aimed to present real-world data from seven centres from Germany and Switzerland according to age differences regarding the outcome, prognosis, WCD data and compliance.MATERIALS AND METHODS:Between 04/2012 and 03/2021, 1105 patients were included in this registry. Outcome data according to age differences (old ≥45 years compared to young <45 years) were analysed. At young age, WCDs were more often prescribed due to congenital heart disease and myocarditis. On the other hand, ischaemic cardiomyopathy (ICM) was more present in older patients. Wear days of WCD were similar between both groups (p = .115). In addition, during the WCD use, documented arrhythmic life-threatening events were comparable [sustained ventricular tachycardia: 5.8% vs. 7.7%, ventricular fibrillation (VF) .5% vs. .6%] and consequently the rate of appropriate shocks was similar between both groups. Left ventricular ejection fraction improvement was documented over follow-up with a better improvement in younger patients as compared to older patients (77% vs. 63%, p = .002). In addition, at baseline, the rate of atrial fibrillation was significantly higher in the older age group (23% vs. 8%; p = .001). The rate of permanent cardiac implantable electronic device implantation (CiED) was lower in the younger group (25% vs. 36%, p = .05). The compliance rate defined as wearing WCD at least 20 h per day was significantly lower in young patients compared to old patients (68.9% vs. 80.9%, p < .001). During the follow-up, no significant difference regarding all-cause mortality or arrhythmic death was documented in both groups. A low compliance rate of wearing WCD is predicted by young patients and patients suffering from non-ischaemic cardiomyopathies.CONCLUSION:Although the compliance rate in different age groups is high, the average wear hours tended to be lower in young patients compared to older patients. The clinical events were similar in younger patients compared to older patients.

BACKGROUND:The Carillon® Mitral Contour System® has been studied in 4 prospective controlled studies in the treatment of functional mitral regurgitation (FMR) where it has been found to reduce mitral regurgitation, reduce left ventricular and atrial volumes, and be associated with improvements in clinical parameters. AIMS:The CINCH post-market registry is designed to evaluate immediate, mid-term and long-term outcomes from a post-approval study of the Carillon® device evaluated in real-world practice. METHODS:The CINCH post-market registry is a single-arm study of percutaneous mitral annuloplasty with the Carillon device in patients with functional (secondary) mitral regurgitation and symptomatic congestive heart failure when utilized in real-world conditions. Patient selection, echocardiographic hemodynamic measurements, and patient follow-up requirements were performed per standard of care at each institution. RESULTS:A total of 101 patients treated with the Carillon device at 13 sites in Germany were enrolled in the CINCH registry. The mean age was 75 ± 9 years, 57 % were male, and patient presentation included primarily NYHA class III (69 %) with MR grade 3 (68 %). Over 5 years of follow-up, all-cause mortality was 40.1 %, the incidence of HFH was 53.9 %, and the composite outcome of HFH or death was 66.4 %. At each follow-up interval through 5 years, statistically significant reductions in NYHA class (p < 0.05) and MR grade (p < 0.01) were reported. CONCLUSIONS:In this "real world" registry of the Carillon Mitral Contour System, procedural safety and medium-term follow-up outcomes is similar to the outcomes seen in the prospective, controlled clinical trials, despite being used in populations of patients that extend outside of those studied in the trials. The use of this therapy in patients with atrial functional mitral regurgitation, and heart failure with preserved ejection fraction, was notable, since these types of patients were excluded from the prospective, controlled trials. This supports possible additional patient populations who might benefit from this type of mechanical therapy. The safety profile of this therapy in this registry and in the earlier trials may support a potential role in earlier forms of secondary mitral regurgitation.

Journal of Cardiovascular ElectrophysiologyVolume 34, Issue 6 p. 1502-1505 LETTER TO THE EDITOR Characteristics and outcome of wearable cardioverter-defibrillator therapy stratified by gender: Insights from a multicenter international registry Mohammad Abumayyaleh MD, Corresponding Author Mohammad Abumayyaleh MD [email protected] orcid.org/0000-0002-4766-5523 Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, University Medical Center Mannheim, Medical Faculty Mannheim, European Center for AngioScience (ECAS) and DZHK (German Center for Cardiovascular Research (DZHK)), Partner Site, Heidelberg/Mannheim, Heidelberg University, Mannheim, Germany Correspondence Mohammad Abumayyaleh, MD, Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany. Email: [email protected]Search for more papers by this authorKatharina Koepsel Medical Student, Katharina Koepsel Medical Student Department of Cardiology and Angiology, Bergmannsheil University Hospitals, Ruhr University of Bochum, Bochum, GermanySearch for more papers by this authorAssem Aweimer MD, Assem Aweimer MD Department of Cardiology and Angiology, Bergmannsheil University Hospitals, Ruhr University of Bochum, Bochum, GermanySearch for more papers by this authorAydan Ewers MD, Aydan Ewers MD Department of Cardiology and Angiology, Bergmannsheil University Hospitals, Ruhr University of Bochum, Bochum, GermanySearch for more papers by this authorJulia W. Erath MD, Julia W. Erath MD orcid.org/0000-0003-3145-6767 Department of Cardiology/Division of Clinical Electrophysiology, University Hospital Frankfurt, Goethe University, Frankfurt, Hessen, GermanySearch for more papers by this authorThomas Kuntz MD, Thomas Kuntz MD Department of Arrhythmias & Invasive Cardiology, St. Georg Hospital, Leipzig, GermanySearch for more papers by this authorNorbert Klein MD, Norbert Klein MD Department of Arrhythmias & Invasive Cardiology, St. Georg Hospital, Leipzig, GermanySearch for more papers by this authorBoldizsar Kovacs MD, MSc, Boldizsar Kovacs MD, MSc Department of Cardiology, University Hospital Zurich, University Heart Center, Zurich, SwitzerlandSearch for more papers by this authorFirat Duru MD, Firat Duru MD Department of Cardiology, University Hospital Zurich, University Heart Center, Zurich, SwitzerlandSearch for more papers by this authorArdan M. Saguner MD, Ardan M. Saguner MD Department of Cardiology, University Hospital Zurich, University Heart Center, Zurich, SwitzerlandSearch for more papers by this authorChristian Blockhaus MD, Christian Blockhaus MD Department of Cardiology Heart Centre Niederrhein Helios Clinic Krefeld Germany, Krefeld, Germany School of Medicine, Faculty of Health, University Witten/Herdecke, Witten, GermanySearch for more papers by this authorDong-In Shin MD, Dong-In Shin MD Department of Cardiology Heart Centre Niederrhein Helios Clinic Krefeld Germany, Krefeld, Germany School of Medicine, Faculty of Health, University Witten/Herdecke, Witten, GermanySearch for more papers by this authorMichael Gotzmann MD, Michael Gotzmann MD orcid.org/0000-0002-5952-0284 University Hospital St. Josef-Hospital Bochum, Cardiology and Rhythmology, Ruhr University Bochum, Bochum, GermanySearch for more papers by this authorHendrik Lapp MD, Hendrik Lapp MD Department of Internal Medicine II, University Hospital Bonn, University of Bonn, Bonn, GermanySearch for more papers by this authorThomas Beiert MD, Thomas Beiert MD Department of Internal Medicine II, University Hospital Bonn, University of Bonn, Bonn, GermanySearch for more papers by this authorAndreas Mügge MD, PhD, Andreas Mügge MD, PhD Department of Cardiology and Angiology, Bergmannsheil University Hospitals, Ruhr University of Bochum, Bochum, Germany Department of Molecular and Experimental Cardiology, Institut für Forschung und Lehre (IFL), Ruhr-University Bochum, Bochum, GermanySearch for more papers by this authorIbrahim El-Battrawy MD, Ibrahim El-Battrawy MD Department of Cardiology and Angiology, Bergmannsheil University Hospitals, Ruhr University of Bochum, Bochum, Germany Department of Molecular and Experimental Cardiology, Institut für Forschung und Lehre (IFL), Ruhr-University Bochum, Bochum, GermanySearch for more papers by this authorIbrahim Akin MD, PhD, Ibrahim Akin MD, PhD Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, University Medical Center Mannheim, Medical Faculty Mannheim, European Center for AngioScience (ECAS) and DZHK (German Center for Cardiovascular Research (DZHK)), Partner Site, Heidelberg/Mannheim, Heidelberg University, Mannheim, GermanySearch for more papers by this author Mohammad Abumayyaleh MD, Corresponding Author Mohammad Abumayyaleh MD [email protected] orcid.org/0000-0002-4766-5523 Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, University Medical Center Mannheim, Medical Faculty Mannheim, European Center for AngioScience (ECAS) and DZHK (German Center for Cardiovascular Research (DZHK)), Partner Site, Heidelberg/Mannheim, Heidelberg University, Mannheim, Germany Correspondence Mohammad Abumayyaleh, MD, Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany. Email: [email protected]Search for more papers by this authorKatharina Koepsel Medical Student, Katharina Koepsel Medical Student Department of Cardiology and Angiology, Bergmannsheil University Hospitals, Ruhr University of Bochum, Bochum, GermanySearch for more papers by this authorAssem Aweimer MD, Assem Aweimer MD Department of Cardiology and Angiology, Bergmannsheil University Hospitals, Ruhr University of Bochum, Bochum, GermanySearch for more papers by this authorAydan Ewers MD, Aydan Ewers MD Department of Cardiology and Angiology, Bergmannsheil University Hospitals, Ruhr University of Bochum, Bochum, GermanySearch for more papers by this authorJulia W. Erath MD, Julia W. Erath MD orcid.org/0000-0003-3145-6767 Department of Cardiology/Division of Clinical Electrophysiology, University Hospital Frankfurt, Goethe University, Frankfurt, Hessen, GermanySearch for more papers by this authorThomas Kuntz MD, Thomas Kuntz MD Department of Arrhythmias & Invasive Cardiology, St. Georg Hospital, Leipzig, GermanySearch for more papers by this authorNorbert Klein MD, Norbert Klein MD Department of Arrhythmias & Invasive Cardiology, St. Georg Hospital, Leipzig, GermanySearch for more papers by this authorBoldizsar Kovacs MD, MSc, Boldizsar Kovacs MD, MSc Department of Cardiology, University Hospital Zurich, University Heart Center, Zurich, SwitzerlandSearch for more papers by this authorFirat Duru MD, Firat Duru MD Department of Cardiology, University Hospital Zurich, University Heart Center, Zurich, SwitzerlandSearch for more papers by this authorArdan M. Saguner MD, Ardan M. Saguner MD Department of Cardiology, University Hospital Zurich, University Heart Center, Zurich, SwitzerlandSearch for more papers by this authorChristian Blockhaus MD, Christian Blockhaus MD Department of Cardiology Heart Centre Niederrhein Helios Clinic Krefeld Germany, Krefeld, Germany School of Medicine, Faculty of Health, University Witten/Herdecke, Witten, GermanySearch for more papers by this authorDong-In Shin MD, Dong-In Shin MD Department of Cardiology Heart Centre Niederrhein Helios Clinic Krefeld Germany, Krefeld, Germany School of Medicine, Faculty of Health, University Witten/Herdecke, Witten, GermanySearch for more papers by this authorMichael Gotzmann MD, Michael Gotzmann MD orcid.org/0000-0002-5952-0284 University Hospital St. Josef-Hospital Bochum, Cardiology and Rhythmology, Ruhr University Bochum, Bochum, GermanySearch for more papers by this authorHendrik Lapp MD, Hendrik Lapp MD Department of Internal Medicine II, University Hospital Bonn, University of Bonn, Bonn, GermanySearch for more papers by this authorThomas Beiert MD, Thomas Beiert MD Department of Internal Medicine II, University Hospital Bonn, University of Bonn, Bonn, GermanySearch for more papers by this authorAndreas Mügge MD, PhD, Andreas Mügge MD, PhD Department of Cardiology and Angiology, Bergmannsheil University Hospitals, Ruhr University of Bochum, Bochum, Germany Department of Molecular and Experimental Cardiology, Institut für Forschung und Lehre (IFL), Ruhr-University Bochum, Bochum, GermanySearch for more papers by this authorIbrahim El-Battrawy MD, Ibrahim El-Battrawy MD Department of Cardiology and Angiology, Bergmannsheil University Hospitals, Ruhr University of Bochum, Bochum, Germany Department of Molecular and Experimental Cardiology, Institut für Forschung und Lehre (IFL), Ruhr-University Bochum, Bochum, GermanySearch for more papers by this authorIbrahim Akin MD, PhD, Ibrahim Akin MD, PhD Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, University Medical Center Mannheim, Medical Faculty Mannheim, European Center for AngioScience (ECAS) and DZHK (German Center for Cardiovascular Research (DZHK)), Partner Site, Heidelberg/Mannheim, Heidelberg University, Mannheim, GermanySearch for more papers by this author First published: 13 April 2023 https://doi.org/10.1111/jce.15905 Disclosures: None. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat REFERENCES 1Solomon SD, Zelenkofske S, McMurray JJV, et al. Sudden death in patients with myocardial infarction and left ventricular dysfunction, heart failure, or both. N Engl J Med. 2005; 352(25): 2581-2588. 2Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. 2017 aha/acc/hrs guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: executive summary: a report of the American college of cardiology/American heart association task force on clinical practice guidelines and the heart rhythm society. Circulation. 2018; 138(13): 210. 3Feldman AM, Klein H, Tchou P, et al. Use of a wearable defibrillator in terminating tachyarrhythmias in patients at high risk for sudden death: results of WEARIT/BIROAD. Pacing Clin Electrophysiol. 2004; 27(1): 4-9. 4Abumayyaleh M, Dreher TC, Rosenkaimer S, et al. Sex differences and adherence of patients treated with wearable cardioverter-defibrillator: insights from an international multicenter register. J Cardiovasc Electrophysiol. 2022; 33(11): 2243-2249. 5Manteuffel M, Williams S, Chen W, Verbrugge RR, Pittman DG, Steinkellner A. Influence of patient sex and gender on medication use, adherence, and prescribing alignment with guidelines. J Women's Health. 2014; 23(2): 112-119. Volume34, Issue6June 2023Pages 1502-1505 ReferencesRelatedInformation

BACKGROUND:Atrial fibrillation (AF) is associated with significant morbidity and is predicted by atrial high rate events. The early detection of AF is paramount to timely interventions to reduce the morbidity of AF. The DX ICD system combined with Home Monitoring® allows for continuous atrial rhythm monitoring without the need for a dedicated atrial lead.OBJECTIVE:To establish the reaction to and timing of reactions to the detection of atrial high rate episodes (AHRE).METHODS:A prospective cohort of DX ICD systems was followed up and the response to AHREs was collected and evaluated.RESULTS:A total of 234 patients were enrolled; an AHRE ⩾ 6 min was detected in 13.7% of patients (n= 32) within a mean follow-up duration of 16 months. A high rate of oral anticoagulation (OAC) prescription was seen with the detection of AHREs in patients with a not-low risk CHA2DS2-VASc score. There was a delay in this prescription highlighting the potential to improve the timeliness of patient care in this group of patients.CONCLUSIONS:The DX ICD system provides rapid and ongoing atrial rhythm monitoring such that physicians are rapidly aware of AHRE without the need for a dedicated atrial lead, but local protocols are needed to improve the response time of anti-coagulation prescription.

Patients at high risk for sudden cardiac death (SCD) may benefit from wearable cardioverter defibrillators (WCD) by avoiding immediate implantable cardioverter defibrillator (ICD) implantation. Different factors play an important role including patient selection, compliance and optimal drug treatment. We aimed to present real world data from 4 centers from Germany and Switzerland. Between 04/2012 and 03/2019, 708 patients were included in this registry. Patients were followed up over a mean time of 28 ± 35.5 months. Outcome data including gender differences and different etiologies of cardiomyopathy were analyzed. Out of 708 patients (81.8% males, mean age 61.0 ± 14.6), 44.6% of patients had non-ischemic cardiomyopathy, 39.8% ischemic cardiomyopathy, 7.9% myocarditis, 5.4% prior need for ICD explantation and 2.1% channelopathy. The mean wear time of WCD was 21.2 ± 4.3 h per day. In 46% of patients, left ventricular ejection fraction (LVEF) was > 35% during follow-up. The younger the patient was, the higher the LVEF and the lower the wear hours per day were. The total shock rate during follow-up was 2.7%. Whereas an appropriate WCD shock was documented in 16 patients (2.2%), 3 patients received an inappropriate ICD shock (0.5%). During follow-up, implantation of a cardiac implantable electronic device was carried out in 34.5% of patients. When comparing German patients (n = 516) to Swiss patients (n = 192), Swiss patients presented with longer wear days (70.72 ± 49.47 days versus 58.06 ± 40.45 days; p = 0.001) and a higher ICD implantation rate compared to German patients (48.4% versus 29.3%; p = 0.001), although LVEF at follow-up was similar between both groups. Young age is a negative independent predictor for the compliance in this large registry. The most common indication for WCD was non-ischemic cardiomyopathy followed by ischemic cardiomyopathy. The compliance rate was generally high with a decrease of wear hours per day at younger age. Slight differences were found between Swiss and German patients, which might be related to differences in mentality for ICD implantation.

Aims The treatment with the wearable cardioverter defibrillator (WCD) may protect against sudden cardiac death (SCD) as a bridging therapy until a cardioverter-defibrillator may be implanted. We analyzed in a multicenter setting a consecutive patient cohort wearing WCD to explore gender differences. Methods and results We analyzed 708 consecutive patients, 579 from whom were males and 129 females (age, 60.5±14 vs. 61.6±17 years old; p=0.44). All patients were divided into age quartiles for analysis. While the rate of ischemic cardiomyopathy (ICM) as a cause of prescription of WCD was significantly higher in males as compared to females (42.7% vs. 26.4%; p=0.001), females received it more frequently due to non-ischemic cardiomyopathy (NICM) (55.8% vs. 42.7%); p=0.009). The wear time of WCD was equivalent in both groups (21.1±4.3 hours/days in males vs. 21.5±4.4 hours/days in females; p=0.27; and 62.6±44.3 days in males vs. 56.5±39 days in females; p=0.15). Mortality was comparable in both groups at 2-year-follow-up (6.8% in males vs. 9.7% in females; p=0.55). Appropriate WCD shocks and the incidence of device implantations were similar in both groups (2.4% in males vs. 3.9% in females; p=0.07) (35.1% in males vs. 31.8% in females; p=0.37), respectively. In age quartile analysis, compliance was observed more in older patients as compared to adult patients (87.8% vs. 68.3%; p<0.001). Conclusion Compliance for wearing WCD was excellent regardless of gender. Furthermore, mortality and the incidence of device implantations were comparable in both groups. Appropriate WCD shocks tended to be higher in females as compared to males.

To investigate the long-term prognostic value of aspiration thrombectomy in conjunction with primary percutaneous coronary intervention (PCI) compared to conventional PCI in patients with non-ST-elevation myocardial infarction (NSTEMI). In the randomized TATORT-NSTEMI (Thrombus aspiration in thrombus containing culprit lesions in non-ST-elevation myocardial infarction) trial, NSTEMI patients with thrombus containing culprit lesions were randomized to either PCI with aspiration thrombectomy or conventional PCI. The endpoint was a combination of all-cause death, reinfarction and new congestive heart failure. From 440 patients initially randomized, outcome data were available in 432 (98.2%) patients at a median follow-up of 4.9 (interquartile range [IQR] 4.4–5.0) years. Thrombectomy was associated with a significant reduction of the combined endpoint compared to conventional PCI (19.9% vs. 30.7%, p = 0.01). This finding was primarily driven by a reduced rate of reinfarction with thrombectomy (3.4% vs. 10.3%, p = 0.01). Thrombectomy was still independently associated with the combined endpoint after multivariable adjustment (hazard ratio [HR] 0.47, 95% confidence interval [CI] 0.30–0.76, p = 0.002). Findings were consistent across all analyzed subgroups (p values for interaction all > 0.05). In NSTEMI, thrombus aspiration is associated with favorable clinical outcome during long-term follow-up. NCT01612312.

BackgroundThe REACT DX registry evaluates standard therapies to episodes of long-lasting atrial tachyarrhythmias and assesses the quality of sensing and stability of the lead and the implantable cardioverter-defibrillator (ICD) (BIOTRONIK Lumax VR-T DX and successors) over at least a 1-year follow-up period.ObjectiveTo study the association between the risk of de novo device-detected atrial fibrillation (AF), the autonomic perturbations before the onset of paroxysmal AF and a 7-days heart rate variability (7dHRV) 1 month after ICD implantation.MethodsThe registry consists of 234 patients implanted with an ICD, including 10 with de novo long-lasting atrial tachyarrhythmias with no prior history of AF. The patients were matched via the propensity-score methodology as well as for properties directly influencing the ECGs recorded using GE CardioMem CM 3000. Heart rate variability (HRV) analysis was performed using standard parameters from time- and frequency-domains, and from non-linear dynamics.ResultsNo linear HRV was associated with an increased risk of AF (p = n.s.). The only significant approach was derived from symbolic dynamics with the parameter “forbidden words” which distinguished both groups on all 7 days of measurements (p < 0.05), thereby quantifying the heart rate complexity (HRC) as drastically lower in the de novo AF group.ConclusionCardiac autonomic dysfunction denoted by low HRC may be associated with higher AF incidence. For patients with mild to moderate heart failure, standard HRV parameters are not appropriate to quantify cardiac autonomic perturbations before the onset of AF. Further studies are needed to determine the individual risk for AF that would enable interventions to restore autonomic balance in the general population.

Der Schritt von der invasiven elektrophysiologischen Diagnostik von Arrhythmien zur interventionellen Behandlung – zur Katheterablation – lag von den Anfängen der His-Bündel-Elektrographie im Jahr 1967 an nahe. Dabei war das Zeitintervall von 15 Jahren zwischen Diagnostik und Therapie bei Arrhythmien sogar kürzer, als die Zeit, die zwischen der ersten selektiven Koronarangiographie 1958 an der Cleveland-Klinik in den USA bis zur ersten perkutanen Koronartherapie 1977 in Zürich (19 Jahre) lag. In beiden Fällen wurden in diesem Zeitraum vielfältige Erfahrungen bei der kardiochirurgischen Behandlung gesammelt, die sich für die Entwicklung der interventionellen Therapie als sehr hilfreich erwiesen. Damit erinnert die Geschichte der endovaskulären Behandlung eindrucksvoll daran, dass die Weiterentwicklung der internistischen kardiologischen Therapie der Vorarbeit, Mithilfe, der Unterstützung und manchmal auch des Komplikationsmanagements der Kardiochirurgen bedurfte. Wenn man aus der Geschichte der Katheterablation etwas lernen kann, so sollte es die Erkenntnis sein, dass die gemeinsame Arbeit von Kardiologen und Kardiochirurgen im Herzteam nicht nur dem einzelnen Patienten die für ihn beste Behandlung gestattet, sondern auch die Therapie insgesamt weiterentwickeln hilft.

Patients with a left ventricular ejection fraction (LVEF) ≤35% should be protected from sudden cardiac death with an implantable cardioverter-defibrillator (ICD). The onset of the effect of optimal medical therapy (OMT) is unclear, and a wearable cardioverter-defibrillator (WCD) can bridge this period. Our study analyzed 104 patients (age, 68.9 ± 11.7 years; 81% [84/104] male) whose first diagnosis included an LVEF <35%. After exclusion of reversible causes for LVEF reduction and initiation/adjustment of the OMT, the WCD was employed. The LVEF and indication for ICD were re-evaluated after 62 ± 36 days. The LVEF development and implantation rate were correlated with underlying disease (ischemic [ICM] or nonischemic cardiomyopathy [NICM]), comorbidities, and age/gender. The wearing time of the WCD was 22.8 ± 1.9 h/day. An LVEF improvement from 28.5 ± 6.4% to 40 ± 11.7% was achieved through OMT (p < 0.0001). An improvement in LVEF of up to more than 35% was achieved in 66 of 104 patients (63%), and only 37% of patients were subsequently given an ICD. This affected 41% of patients with ICM and 30% of patients with NICM (p = 0.205). Notably, no ICD interventions were observed over 362 ± 89.5 days after implantation in the ICD-receiver group. The indication for ICD can be re-evaluated after 2 months. Patients with NICM respond better to OMT compared with ICM patients. The LVEF recovered to >35% in >60% of cases.

INTRODUCTION:Stroke is one of the most feared complications during catheter ablation of atrial fibrillation (AF). While symptomatic thromboembolic events are rare, magnetic resonance imaging (MRI) may identify asymptomatic (ie, silent) cerebral lesions (SCLs) following pulmonary vein isolation (PVI) procedures.METHODS AND RESULTS:The REDUCE-TE Pilot was a prospective multicenter, single-arm observational study investigating the incidence of SCL in patients with symptomatic paroxysmal AF undergoing PVI with a novel gold-tip, externally irrigated ablation catheter. After ablation, cerebral diffusion-weighted MRI and a postablation follow-up were performed at 1 to 3 days after the ablation procedure. A neurocognitive test was done before and after ablation. The primary study endpoint was the occurrence of one or more new SCLs. Secondary study endpoints included neurocognitive status, procedural success rate, and periprocedural complications including symptomatic thromboembolic events. A total of 104 patients were enrolled (69% male, mean age: 61.5 ± 9.7 years, mean CHA2 DS 2 -VASc score: 1.7 ± 1.2). Postprocedural MRI examination was performed in 97 patients, and in nine of them (9.3%; 95% CI: 4.3-16.9%) a total of 11 SCLs were detected. Univariate analyses did not reveal any significant predictor for new SCLs. Nonsignificant trends were observed for low activated clotting time during ablation and for international normalized ratio value outside the range of 2 to 3 at ablation. There was no evidence of significant deterioration of neurocognitive function after PVI. In four patients, a pericardial tamponade was noted but all patients fully recovered during follow-up.CONCLUSIONS:Ablation of AF using a novel gold-tip, externally irrigated ablation catheter, resulted in SCLs in approximately one out of 10 patients without a measurable effect on neurocognitive function.

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