Nejvíce citovaný článek - PubMed ID 25820161
The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): first annual report
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.
- Klíčová slova
- EUROMACS, Left ventricular assist device, Mechanical circulatory support,
- MeSH
- lidé středního věku MeSH
- lidé MeSH
- podpůrné srdeční systémy * škodlivé účinky statistika a číselné údaje MeSH
- registrace * MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- Geografické názvy
- Evropa epidemiologie 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.
- Klíčová slova
- Cerebrovascular accidents, Heart failure, Infection, Left ventricular assist device, Thromboembolic events,
- MeSH
- antibakteriální látky MeSH
- antikoagulancia MeSH
- cévní mozková příhoda * epidemiologie etiologie MeSH
- lidé MeSH
- podpůrné srdeční systémy * škodlivé účinky MeSH
- registrace MeSH
- retrospektivní studie MeSH
- srdeční selhání * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- antibakteriální látky MeSH
- antikoagulancia MeSH
OBJECTIVES: Data on the impact and course of uncorrected tricuspid regurgitation (TR) during left ventricular assist device (LVAD) implantation are scarce and inconsistent. This study explores the clinical impact and natural course of uncorrected TR in patients after LVAD implantation. METHODS: The European Registry for Patients with Mechanical Circulatory Support was used to identify adult patients with LVAD implants without concomitant tricuspid valve surgery. A mediation model was developed to assess the association of TR with 30-day mortality via other risk factors. Generalized mixed models were used to model the course of post-LVAD TR. Joint models were used to perform sensitivity analyses. RESULTS: A total of 2496 procedures were included (median age: 56 years; men: 83%). TR was not directly associated with higher 30-day mortality, but mediation analyses suggested an indirect association via preoperative elevated right atrial pressure and creatinine (P = 0.035) and bilirubin (P = 0.027) levels. Post-LVAD TR was also associated with increased late mortality [hazard ratio 1.16 (1.06-1.3); P = 0.001]. On average, uncorrected TR diminished after LVAD implantation. The probability of having moderate-to-severe TR immediately after an implant in patients with none-to-mild TR pre-LVAD was 10%; in patients with moderate-to-severe TR pre-LVAD, it was 35% and continued to decrease in patients with moderate-to-severe TR pre-LVAD, regardless of pre-LVAD right ventricular failure or pulmonary hypertension. CONCLUSIONS: Uncorrected TR pre-LVAD and post-LVAD is associated with increased early and late mortality. Nevertheless, on average, TR diminishes progressively without intervention after an LVAD implant. Therefore, these data suggest that patient selection for concomitant tricuspid valve surgery should not be based solely on TR grade.
- Klíčová slova
- Left ventricular assist device, Mortality, Natural course, Tricuspid regurgitation,
- MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- podpůrné srdeční systémy * škodlivé účinky MeSH
- registrace MeSH
- retrospektivní studie MeSH
- srdeční selhání * chirurgie MeSH
- trikuspidální insuficience * epidemiologie chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
AIMS: Sufficient myocardial recovery with the subsequent explantation of a left ventricular assist device (LVAD) occurs in approximately 1-2% of the cases. However, follow-up data about this condition are scarcely available in the literature. This study aimed to report the long-term outcomes and clinical management following LVAD explantation. METHODS AND RESULTS: An analysis of the European Registry for Patients with Mechanical Circulatory Support was performed to identify all adult patients with myocardial recovery and successful explantation. Pre-implant characteristics were retrieved and compared with the non-recovery patients. The follow-up data after explantation were collected via a questionnaire. A Kaplan-Meier analysis for freedom of the composite endpoint of death, heart transplantation, LVAD reimplantion, or heart failure (HF) relapse was conducted. A total of 45 (1.4%) cases with myocardial recovery resulting in successful LVAD explantation were identified. Compared with those who did not experience myocardial recovery, the explanted patients were younger (44 vs. 56 years, P < 0.001), had a shorter duration of cardiac disease (P < 0.001), and were less likely to have ischaemic cardiomyopathy (9% vs. 41.8%, P < 0.001). Follow-up after explantation could be acquired in 28 (62%) cases. The median age at LVAD implantation was 43 years (inter-quartile range: 29-52), and 23 (82%) were male. Baseline left ventricular ejection fraction was 18% (inter-quartile range: 10-20%), and 60.7% of the patients had Interagency Registry for Mechanically Assisted Circulatory Support Profile 1 or 2. Aetiologies of HF were dilated cardiomyopathy in 36%, myocarditis in 32%, and ischaemic in 14% of the patients, and 18% had miscellaneous aetiologies. The devices implanted were HeartMate II in 14 (50%), HVAD in 11 (39%), HeartMate 3 in 2 (7%), and 1 unknown with a median duration of support of 410 days (range: 59-1286). The median follow-up after explantation was 26 months (range 0.3-73 months), and 82% of the patients were in New York Heart Association Class I or II. Beta-blockers were prescribed to 85%, angiotensin-converting enzyme inhibitors to 71%, and loop diuretics to 50% of the patients, respectively. Freedom from the composite endpoint was 100% after 30 days and 88% after 2 years. CONCLUSIONS: The survival after LVAD explantation is excellent without the need for heart transplantation or LVAD reimplantation. Only a minority of the patients suffer from a relapse of significant HF.
- Klíčová slova
- Explantation, Left ventricular assist device, Mechanical circulatory support, Myocardial recovery, Survival,
- MeSH
- dospělí MeSH
- funkce levé komory srdeční MeSH
- lidé MeSH
- podpůrné srdeční systémy * MeSH
- srdeční selhání * chirurgie MeSH
- tepový objem MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH