Leon Dinshaw

Background: Atrial fibrillation (AF) is common in hypertrophic cardiomyopathy (HCM) and increases stroke risk, primarily due to thromboembolism from the left atrial appendage (LAA). Oral anticoagulation (OAC) is recommended, but data on LAA thrombus (LAAT) in HCM and AF are limited. The current study aimed to assess LAAT prevalence in patients with HCM and AF. Methods: We retrospectively analyzed 170 patients with HCM and AF (mean age, 67.7±12.4 years; 57.1% men) who underwent at least one transesophageal echocardiogram (TEE) during a median follow‐up of 41.5 months (interquartile range, 15–77 months). Results: At the time of TEE, 147 (86.5%) patients were undergoing OAC, with 52 (30.6%) taking vitamin K antagonists and 95 (55.9%) taking non–vitamin K antagonist oral anticoagulants. LAAT was found in 36 patients (21.2%), with prevalence rates of 23.1% (n=12) in vitamin K antagonist users, 16.8% (n=16) in non–vitamin K antagonist oral anticoagulant users, and 34.8% (n=8) in those without OAC. Non–vitamin K antagonist oral anticoagulant use was associated with a significant LAAT risk reduction compared with no OAC (odds ratio, 0.20 [95% CI, 0.05–0.73]; P =0.02). Decreased LAA flow velocity ( P <0.001) was independently linked to LAAT. Conclusions: LAAT is common in patients with HCM and AF, even among those receiving OAC. Reduced LAA flow velocity may increase thrombus risk. TEE should be considered before rhythm‐control strategies, even in patients with HCM receiving anticoagulation, to minimize thromboembolic complications.

Aims: Ventricular tachycardia (VT) in ischaemic heart disease (IHD) requires complex management strategies including catheter ablation (CA) and anti-arrhythmic drugs (AADs). The aim of this study is to compare efficacy and safety of CA vs. AADs in patients with IHD and VT. Methods and results: We performed a meta-analysis of randomized controlled trials (RCTs) enrolling patients with IHD and ICD randomized to CA or AADs. Primary outcome was appropriate ICD therapy. Secondary outcomes included inappropriate ICD therapy, cardiovascular (CV) re-hospitalization, all-cause/CV mortality, and adverse events. Subgroup analyses were conducted for amiodarone and sotalol, with an exploratory evaluation of a composite endpoint (ICD shock, VT storm, all-cause death). Four RCTs including 947 patients (mean age 68 ± 2 years; 93% male) were analysed. CA significantly reduced the risk of appropriate ICD therapy compared with AADs (149/470 [31.7%] vs. 229/477 [48.0%]; RR 0.81; 95% CI [0.67, 0.97]; P = 0.02). Among secondary outcomes, CA decreased the incidence of CV re-hospitalization [RR 0.84; 95% CI (0.72, 0.99); P = 0.04] and adverse events [RR 0.42; 95% CI (0.28, 0.62); P < 0.01], while no differences were observed in all-cause/CV mortality and inappropriate ICD therapy. In subgroup analyses, CA was superior to sotalol in reducing the composite endpoint of ICD shock, VT storm and all-cause death [RR: 0.82, 95% CI (0.69, 0.98), P = 0.03]; whereas, no significant benefit was seen compared to amiodarone [RR: 0.92; 95% CI (0.78, 1.09), P = 0.32]. Conclusion: In ischaemic heart disease and VT, CA compared with anti-arrhythmic drugs is associated with a reduction of appropriate ICD therapy, cardiovascular re-hospitalization, and adverse events with benefits most evident versus sotalol.

Aims: The 2020 European Society of Cardiology (ESC)–atrial fibrillation (AF) guidelines recommend a risk-based approach to oral anticoagulation (OAC) therapy in patients with AF; however, it is unknown if current practice aligns with these recommendations. This study assessed the associated effectiveness and safety of edoxaban in patients with AF according to the 2020 ESC-AF guidelines and the approved label in routine clinical care. Methods and results: The Global ETNA-AF programme is a large prospective, noninterventional programme evaluating safety and effectiveness of edoxaban. Baseline characteristics and 2-year clinical event data were analysed in subgroups, defined by ESC-AF guidelines indication of OAC therapy according to CHA2DS2-VASc score [no OAC to be considered, OAC should be considered (2 for females/1 for males), and OAC recommended (≥3 for females/≥2 for males)] and modified HAS-BLED score [(≥3 (bleeding risk high) vs. <3 (bleeding risk low)]. Of 19 960 patients included, 16 912 (84.7%) were categorized as OAC recommended and 2501 (12.5%) as OAC should be considered; 547 (2.7%) were in the no OAC to be considered group. In the OAC recommended group, 12 006 (71.0%) had high bleeding risk. Clinical event rates were <5%/year across all risk groups, even in the OAC recommended and high bleeding risk groups. In the OAC recommended and high bleeding risk groups, patients had low ischaemic stroke and bleeding event rates, regardless of receiving the 30 or 60 mg dose. Conclusion: This study demonstrated that edoxaban use in patients with AF largely aligns with 2020 ESC-AF guidelines, while maintaining low clinical event rates. Registration: Europe (NCT02944019), Japan (UMIN000017011), and Korea/Taiwan (NCT02951039).

Orale Nicht-Vitamin-K-Antikoagulanzien (NOAKs) sind sicher und wirksam in der Schlaganfallprävention bei Patienten mit Vorhofflimmern (AF). Es gibt jedoch nur wenige Daten zur Sicherheit und Wirksamkeit der oralen Antikoagulation mit Edoxaban im deutschsprachigen Raum in der Routineversorgung. Wir berichten über die Ein-Jahres-Ergebnisse der Patienten, die in Deutschland, Österreich und der Schweiz (DACH) im Rahmen der ETNA-AF-Europa-Studie mit Edoxaban zur Schlaganfallprävention behandelt wurden. Die ETNA-AF-Europa-Studie (Clinicaltrials.gov:NCT02 944 019) ist eine multizentrische, prospektive Beobachtungsstudie, in die mit Edoxaban zur Schlaganfallprävention bei AF behandelte Patienten (n = 13 092) aus 852 Zentren in 10 europäischen Ländern aufgenommen wurden. Die DACH-Kohorte besteht aus 5457 (41,7 %) Patienten aus Zentren in Deutschland, Österreich und der Schweiz. Die Patienten (74 Jahre, 2384 [44 %] Frauen) hatten im Mittel einen CHA₂DS₂-VASc-Score von 3,2 ± 1,4 – und eine labelkonforme Dosierung von Edoxaban wurde von 4309 Patienten (78,9 %) eingenommen. Nach einem Beobachtungszeitraum von einem Jahr traten bei 42 Patienten (0,8 %/Jahr) ein Schlaganfall oder ein systemisch embolisches Ereignis auf, und bei 36 Patienten (0,7 %/Jahr) kam es zu einem schweren Blutungsereignis, was bei 10 Patienten (0,2 %/Jahr) auf eine intrakranielle Blutung und bei 13 Patienten (0,3 %/Jahr) auf eine schwere gastrointestinale (GI) Blutung zurückzuführen war. Schwere und klinisch relevante, nicht schwere Blutungen zusammengenommen ereigneten sich bei insgesamt 72 Patienten (1,4 %/Jahr) über den Beobachtungszeitraum. Die Gesamtmortalität lag bei 179 Patienten (3,4 %/Jahr), wobei 85 (1,6 %/Jahr) an einer kardiovaskulären Todesursache verstarben. Bei Patienten mit einem erhöhten Lebensalter, einem gebrechlichen Allgemeinzustand, einem CHA₂DS₂-VASc-Score ≥ 4 zeigten sich eine höhere Gesamtmortalität und eine höhere Rate von Schlaganfällen sowie schweren Blutungsereignissen. In Deutschland, Österreich und der Schweiz ist die Ereignisrate der Schlaganfälle und schweren Blutungen bei Patienten, die zur Schlaganfallprävention bei AF mit Edoxaban behandelt wurden, niedrig. Eine zunehmende Morbidität geht mit einer höheren Rate der relevanten klinischen Endpunkte einher. Non-vitamin-K oral anticoagulants (NOACs) are safe and effective for stroke prevention in patients with atrial fibrillation (AF). Data on the safety and efficacy of Edoxaban in routine care in Germany, Austria and Switzerland (DACH) are limited. We report one-year outcomes in patients with AF treated with Edoxaban in routine care. The ETNA-AF-Europe study (Clinicaltrials.gov:NCT02 944 019) is a multicenter, prospective, observational study that enrolled 13 092 patients with AF treated with Edoxaban from 852 sites across 10 European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Portugal, Spain, Switzerland, and the United Kingdom). The DACH-cohort consists of 5457 (41,7 %) patients of sites in Germany, Austria and Switzerland. Patients had a mean age of 74 years (2384 [44 %]women) and a mean CHA₂DS₂-VASc-score of 3.2 ± 1.4. A label-conform dosing of Edoxaban was administered to 4309 patients (78,9 %). At the one-year-follow-up a stroke or systemic embolism occurred in 42 patients (0,8 %/year), and severe bleeding was reported in 36 patients (0,7 %/year). Ten patients (0,2 %/year) suffered intracranial and 13 patients (0,3 %/year)gastrointestinal bleeding. Numbers of death from all causes and cardiovascular death occurred in 179 patients (3,4 %/year) and 85 patients (1,6 %/year), respectively. Age > 75 years, frailty and a CHA₂DS₂-VASc score ≥ 4 were associated with a higher all-cause mortality – and those patients were more likely to suffer a stroke or a major bleeding event. In Germany, Austria and Switzerland in patients with AF on Edoxaban therapy for stroke prevention the number of stroke and major bleeding events is low. Increasing morbidity is associated with a higher number of important clinical events. Article published online: 03 July 2024 © 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/) Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany