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Purpose The aim of the study was to analyze early mortality after continuous-flow left ventricular assist device (LVAD) implantation which remains high. Methods We analyzed consecutive (n = 2689) patients from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) undergoing continuous-flow LVAD implantation. The primary outcome was early (< 90 days) mortality. Secondary outcomes were differential causes of early post-operative death following LVAD implantation. Results Univariable and multivariable analysis as well as regression analysis were used to examine determinants and differential causes of early (< 90 days) mortality after LVAD implantation. During the first 90 days, 2160 (80%) patients were alive with ongoing LVAD support, 40(2%) patients underwent heart transplantation, and 487(18%) deceased. The main causes of early death were MOF (36%), sepsis (28%), cardiopulmonary failure (CPF; 10%), CVA (9%), and right-sided heart failure (RHF, 8%). Furthermore, MOF and sepsis are 70% of causes of death in the first week. Independent clinical predictors of early death were age, female sex, INTERMACS profile 1 to 3, and ECMO. Laboratory predictors included elevated serum creatinine, total bilirubin, lactate, and low hemoglobin. Furthermore, hemodynamic predictors included elevated RA-to-PCWP ratio, pulmonary vascular resistance, and low systemic vascular resistance. Longer total implantation time was also independent predictor of early mortality. A simple model of 12 variables predicts early mortality following LVAD implantation with a good discriminative power with area under the curve of 0.75. Conclusions In the EUROMACS registry, approximately one out of five patients die within 90 days after LVAD implantation. Early mortality is primarily dominated by multiorgan failure followed by sepsis. A simple model identifies important parameters which are associated with early mortality following LVAD implantation., Author(s): Sakir Akin [sup.1] [sup.2], Osama Soliman [sup.3], Theo M. M. H. de By [sup.4], Rahatullah Muslem [sup.1], Jan G. P. Tijssen [sup.5] [sup.6], Felix Schoenrath [sup.7], Bart Meyns [sup.8], [...]

Background: We investigated the clinical outcomes after cardiac valvular surgery procedures concomitant (CCPs) with left ventricular assist device (LVAD) implantation compared to propensity score (PS) matched controls using the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) data. Methods: Between 2006 and 2018, 2760 continuous‐flow LVAD patients were identified. Of these, 533 underwent a CCP during the LVAD implant. Results: Cardiopulmonary bypass time (p < 0.001) and time for implant (p < 0.001) were both significantly longer in the LVAD+CCP group. Hospital mortality was comparable between the two groups from the unmatched population (15.7% vs. 14.1%, p = 0.073). Similarly, short‐to‐mid‐term survival was similar in both groups, with 1‐year, 3‐year, and 5‐year survival rates of 67.9%, 48.2%, and 27.7% versus 66.4%, 46.1%, and 26%, respectively (log‐rank, p = 0.25). The results were similar in the PS‐matched population. Hospital mortality was comparable between the two groups (18.9% vs. 17.4%, p = 0.074). The short‐to‐mid‐term Kaplan–Meier survival analysis was similar for both groups, with 1‐year, 3‐year, and 5‐year survival rates of 63.4%, 49.2%, and 24.7% versus 66.5%, 46%, and 25.1%, respectively (log‐rank, p = 0.81). In the unmatched population, LVAD+CCP patients had longer intensive care unit (ICU) stays (p < 0.0001), longer mechanical ventilation time (p = 0.001), a higher rate of temporary right ventricular assist device (RVAD) support (p = 0.033), and a higher rate of renal replacement therapy (n = 35, 6.6% vs. n = 89, 4.0%, p = 0.014). In the PS‐matched population, the LVAD+CCP patients had longer ICU stays (p = 0.019) and longer mechanical ventilation time (p = 0.002). Conclusions: The effect of additive valvular procedures (CCPs) does not seem to affect short‐term survival, significantly, based on our registry data analysis. However, the decision to perform CCPs should be balanced with the projected type of surgery and preoperative characteristics. LVAD+CCP patients remain a delicate population and adverse device‐related events should be strictly monitored and managed. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Mechanical circulatory support (MCS) is an established therapy for end-stage heart failure. The EUROMACS registry was created to promote research in patients with MCS and became a committee of the European Association for Cardio-Thoracic Surgery (EACTS) in 2014. Since 1 January 2011, increasing numbers of European centres implanting durable MCS have reported their patient data to EUROMACS. The aim of this study is to compare, as an example of internal quality control, data from a single centre (Bern) with those from the EUROMACS database with respect to mortality rates and preoperative patient characteristics and to describe complications in Bern. METHODS: Patients implanted with MCS between 1 January 2011 and 30 June 2014 in participating centres were included, with extended follow-up as of 31 December 2014. Patient characteristics, operative and postoperative data, clinically significant adverse events and routine follow-up data were reported to the registry. The entire EUROMACS cohort (including the Bern data) was compared with patients from Bern only. Baseline characteristics, operative data and outcomes were compared using standard 95% confidence intervals (CIs) for means, Wilson's continuity corrected CIs for categories and Kaplan-Meier estimates with CIs. RESULTS: Kaplan-Meier estimates show a higher survival rate in the Bern cohort than in the entire EUROMACS cohort at 6 (92%, CI 73-98, vs 66%, CI 62-69), 12 (85%, CI 57-95, vs 56%, CI 52-60) and 18 months (85%, CI 57-95, vs 51%, CI 47-55) after the index operation, respectively. This difference might be caused by the earlier implantation time in Bern (implantation at INTERMACS levels 3-4) versus that of the entire EUROMACS cohort (implantation at INTERMACS levels 2-3). The median number of follow-up records per patient was 2 in the entire EUROMACS cohort and 4 in the Bern (P = 0.001) cohort. During follow-up, neurological dysfunction occurred in 42% of patients, a bleeding event occurred in 42% of patients, significant infection occurred in 36% of patients and a device malfunction occurred in 31% of patients within 12 months of implantation in the Bern patients. CONCLUSIONS: MCS is a valuable therapeutic option with excellent survival rates; nevertheless, it is associated with clinically significant complication rates. International registries are important tools that allow, as an example, internal quality control of mortality, complication and morbidity rates from a single centre compared with the EUROMACS database. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Isolated right ventricular (RV) dysfunction with preserved left ventricular function is difficult to treat and associated with high mortality. Temporary devices for right ventricular support [right ventricular assist device (RVAD)] are available and have been used for short-term right heart assistance. In some patients, RV function does not recover and long-term devices are needed. Recently, isolated RVAD implantation with a permanent HeartWare HeartWare ventricular assist device (HVAD) device has been reported in patients with acute RV infarction and chronic graft failure. However, isolated implantation on the right side remains rare and is still an off-label use for this pump. To gather European data, we queried the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) database, in which procedures and outcome data for patients receiving mechanical circulatory support are registered. METHODS: Until May 2014, data of 8 patients (mean age 55.0 ± 17.3 years, 100% males) with an isolated HVAD for RV support were submitted to the EUROMACS registry. All patients were in INTERMACS classes 1-3. Device strategy was rescue therapy in 6 patients (75.0%) and destination therapy in 2 patients (25.0%). Indications for RVAD placement were acute myocardial infarction in 4 (50.0%), failure to wean from cardiopulmonary bypass in 2 (25.0%) and post-cardiotomy RV failure in another 2 patients (25.0%). Intra- and postoperative results of the EUROMACS registry were analysed. RESULTS: Inflow cannulas were implanted into the right atrium (RA) in 6 patients (75.0%) and into the RV in 2 patients (25.0%). CPB was used in 6 patients (75.0%). Four patients (50.0%) survived the first 30 days. During follow-up, 1 patient died after 44 days due to multiorgan failure. In the surviving three patients, 2 patients were transplanted after 29 and 419 days, respectively, and, in 1 patient, the device was explanted for pump thrombosis and recovered RV function. CONCLUSION: In this very specific and sick patient cohort within the EUROMACS registry, isolated permanent RVAD implantation is a novel and promising strategy for patients with isolated right heart failure. However, more experience is needed to identify patients who benefit from this technology. [ABSTRACT FROM AUTHOR]

The European Registry for Patients with Mechanical Circulatory Support (EUROMACS) was founded on 10 December 2009 with the initiative of Roland Hetzer (Deutsches Herzzentrum Berlin, Berlin, Germany) and Jan Gummert (Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen, Germany) with 15 other founding international members. It aims to promote scientific research to improve care of end-stage heart failure patients with ventricular assist device or a total artificial heart as long-term mechanical circulatory support. Likewise, the organization aims to provide and maintain a registry of device implantation data and long-term follow-up of patients with mechanical circulatory support. Hence, EUROMACS affiliated itself with Dendrite Clinical Systems Ltd to offer its members a software tool that allows input and analysis of patient clinical data on a daily basis. EUROMACS facilitates further scientific studies by offering research groups access to any available data wherein patients and centres are anonymized. Furthermore, EUROMACS aims to stimulate cooperation with clinical and research institutions and with peer associations involved to further its aims. EUROMACS is the only European-based Registry for Patients with Mechanical Circulatory Support with rapid increase in institutional and individual membership. Because of the expeditious data input, the European Association for Cardiothoracic Surgeons saw the need to optimize the data availability and the significance of the registry to improve care of patients withmechanical circulatory support and its potential contribution to scientific intents; hence, the beginning of their alliance in 2012. This first annual report is designed to provide an overview of EUROMACS' structure, its activities, a first data collection and an insight to its scientific contributions. [ABSTRACT FROM AUTHOR]

Aims: This EUROMACS study was conducted with the primary aim of investigating the association between a centre's annual caseload and postoperative outcomes among patients undergoing left ventricular assist device (LVAD) implantation., Methods and Results: A total of 4802 patients identified between 2011 and 2020 from 35 participating centres were dichotomized based on the annual caseload of the treating centre at the time of device implant (≤30 vs. >30 LVAD implantations/year). The primary endpoint was 1-year survival. Secondary outcomes included overall survival analysis, device-related adverse events and readmissions. Cumulative follow-up was 10 003 patient-years, with a median follow-up of 1.54 years (interquartile range 0.52-3.15). Patients from higher volume centres more frequently presented in INTERMACS levels 1 and 2, suffered from right heart dysfunction and needed inotropic support. No difference was observed in adjusted 1-year survival. Adjusted overall survival probability was lower in higher volume centres (p = 0.002). In the subgroup analysis of HeartMate 3 devices only, higher volume centres were associated with decreased odds of 1-year survival (adjusted odds ratio 0.43, 95% confidence interval 0.20-0.97, p = 0.041). Similar findings were observed in the cumulative (i.e. learning curve) caseload analyses., Conclusion: In patients undergoing LVAD implantation, centre volume was not associated with 1-year survival, but was related to device-related adverse events. Patient profiles differed with respect to centre size. These findings underscore the necessity for ongoing quality improvement initiatives in all centres, regardless of their annual caseload. Efforts are needed to standardize patient selection and preconditioning to further improve patient outcome., (© 2024 The Author(s). European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Objectives: The use of ventricular assist devices (VADs) in children is increasing. However, absolute numbers in individual centres and countries remain small. Collaborative efforts such as the Paedi-European Registry for Patients with Mechanical Circulatory Support (EUROMACS) are therefore essential for combining international experience with paediatric VADs. Our goal was to present the results from the fourth Paedi-EUROMACS report., Methods: All paediatric (<19 years) patients from the EUROMACS database supported by a VAD were included. Patients were stratified into a congenital heart disease (CHD) group and a group with a non-congenital aetiology. End points included mortality, a transplant and recovery. Cox proportional hazard models were used to explore associated factors for mortality, cerebrovascular accident and pump thrombosis., Results: A total of 590 primary implants were included. The congenital group was significantly younger (2.5 vs 8.0 years, respectively, P < 0.001) and was more commonly supported by a pulsatile flow device (73.5% vs 59.9%, P < 0.001). Mortality was significantly higher in the congenital group (30.8% vs 20.4%, P = 0.009) than in the non-congenital group. However, in multivariable analyses, CHD was not significantly associated with mortality [hazard ratio (HR) 1.285; confidence interval (CI) 0.8111-2.036, P = 0.740]. Pump thrombosis was the most frequently reported adverse event (377 events in 132 patients; 0.925 events per patient-year) and was significantly associated with body surface area (HR 0.524, CI 0.333-0.823, P = 0.005), CHD (HR 1.641, CI 1.054-2.555, P = 0.028) and pulsatile flow support (HR 2.345, CI 1.406-3.910, P = 0.001) in multivariable analyses., Conclusions: This fourth Paedi-EUROMACS report highlights the increasing use of paediatric VADs. The patient populations with congenital and non-congenital aetiologies exhibit distinct characteristics and clinical outcomes., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Early right-sided heart failure (RHF) was seen in 22% of recipients of a left ventricular assist device (LVAD) in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). However, the optimal treatment of post-LVAD RHF is not well known. Levosimendan has proven to be effective in patients with cardiogenic shock and in those with end-stage heart failure. We sought to evaluate the efficacy of levosimendan on post-LVAD RHF and 30-day and 1-year mortality., Methods: The EUROMACS Registry was used to identify adults with mainstream continuous-flow LVAD implants who were treated with preoperative levosimendan compared to a propensity matched control cohort., Results: In total, 3661 patients received mainstream LVAD, of which 399 (11%) were treated with levosimendan pre-LVAD. Patients given levosimendan had a higher EUROMACS RHF score [4 (2- 5.5) vs 2 (2- 4); P < 0.001], received more right ventricular assist devices (RVAD) [32 (8%) vs 178 (5.5%); P = 0.038] and stayed longer in the intensive care unit post-LVAD implant [19 (8-35) vs 11(5-25); P < 0.001]. Yet, there was no significant difference in the rate of RHF, 30-day, or 1-year mortality. Also, in the matched cohort (357 patients taking levosimendan compared to an average of 622 controls across 20 imputations), we found no evidence for a difference in postoperative severe RHF, RVAD implant rate, length of stay in the intensive care unit or 30-day and 1-year mortality., Conclusions: In this analysis of the EUROMACS registry, we found no evidence for an association between levosimendan and early RHF or death, albeit patients taking levosimendan had much higher risk profiles. For a definitive conclusion, a multicentre, randomized study is warranted., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)