OBJECTIVES: This 4th report aimed to provide insights into patient characteristics, outcomes and standardized outcome ratios of patients implanted with durable Mechanical Circulatory Support across participating centres in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) registry. METHODS: All registered patients receiving durable mechanical circulatory support up to August 2024 were included. The expected number of events was predicted using penalized logistic regression. Standardized outcome ratios (Observed/Expected events) were presented in plots to assess 30-day and 1-year mortality, ischaemic stroke and major bleeding outcomes. Expected events were estimated using penalized logistic regression using demographics and comorbidities as predictors. Centres with <90% follow-up completeness were excluded from standardized outcome ratio assessment. RESULTS: Analysis included 6962 implants in 6408 patients (457 patients underwent repeated implants) registered in EUROMACS from 17 countries (32 centres) (median age: 58 years, 83% males, 17% Interagency Registry for Mechanically Assisted Circulatory Support class 1). Thirty-day mortality, major bleeding and ischaemic stroke probabilities were 9.6, 12.6% and 2.1%, respectively. Standardized mortality ratios showed variability between centres, ranging from 0 (95% CI 0-0) to 1.4 (95% CI 1.2-1.7). Higher standardized bleeding outcome ratios correlated with higher standardized ischaemic stroke ratio's (Spearman r: 0.56, P = 0.008). CONCLUSIONS: Most included centres perform as expected given the demographics and comorbidities of patients. A positive correlation was found between standardized bleeding and ischaemic stroke ratios, reflecting the need of continuously monitoring of adverse events by quality improvement programs.

• Keywords
• EUROMACS, Left ventricular assist device, Mechanical circulatory support,
• MeSH
• Middle Aged MeSH
• Humans MeSH
• Heart-Assist Devices * adverse effects   statistics & numerical data   MeSH
• Registries * MeSH
• Aged MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Geographicals
• Europe epidemiology   MeSH

OBJECTIVES: In patients supported by a durable left ventricular assist device (LVAD), infections are a frequently reported adverse event with increased morbidity and mortality. The purpose of this study was to investigate the possible association between infections and thromboembolic events, most notable cerebrovascular accidents (CVAs), in LVAD patients. METHODS: An analysis of the multicentre European Registry for Patients Assisted with Mechanical Circulatory Support was performed. Infections were categorized as VAD-specific infections, VAD-related infections and non-VAD-related infections. An extended Kaplan-Meier analysis for the risk of CVA with infection as a time-dependent covariate and a multivariable Cox proportional hazard model were performed. RESULTS: For this analysis, 3282 patients with an LVAD were included with the majority of patients being male (83.1%). During follow-up, 1262 patients suffered from infection, and 457 patients had a CVA. Cox regression analysis with first infection as time-dependent covariate revealed a hazard ratio (HR) for CVA of 1.90 [95% confidence interval (CI): 1.55-2.33; P < 0.001]. Multivariable analysis confirmed the association for infection and CVAs with an HR of 1.99 (95% CI: 1.62-2.45; P < 0.001). With infections subcategorized, VAD-specific HR was 1.56 (95% CI: 1.18-2.08; P 0.002) and VAD-related infections [HR: 1.99 (95% CI: 1.41-2.82; P < 0.001)] remained associated with CVAs, while non-VAD-related infections (P = 0.102) were not. CONCLUSIONS: Infection during LVAD support is associated with an increased risk of developing an ischaemic or haemorrhagic CVA, particularly in the setting of VAD-related or VAD-specific infections. This suggests the need of a stringent anticoagulation management and adequate antibiotic treatment during an infection in LVAD-supported patients.

• Keywords
• Cerebrovascular accidents, Heart failure, Infection, Left ventricular assist device, Thromboembolic events,
• MeSH
• Anti-Bacterial Agents MeSH
• Anticoagulants MeSH
• Stroke * epidemiology   etiology   MeSH
• Humans MeSH
• Heart-Assist Devices * adverse effects   MeSH
• Registries MeSH
• Retrospective Studies MeSH
• Heart Failure * MeSH
• Treatment Outcome MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Names of Substances
• Anti-Bacterial Agents MeSH
• Anticoagulants MeSH