European Registry For Patients With Mechanical Circulatory Support Research Articles

Mechanical circulatory support in patients with congenital heart disease: a european registry for patients with mechanical circulatory support (EUROMACS) study.

This study aims to explore characteristics and clinical outcomes of patients with congenital heart disease (CHD) in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). This is a retrospective study of EUROMACS participants receiving MCS as bridge-to-transplant, possible bridge-to-transplant, or rescue therapy/bridge-to-recovery from 2011 to 2023 (n = 5,340). Adult and paediatric cohorts were analysed separately. The primary outcome was mortality on MCS; secondary outcomes included recovery, transplant and complications including bleeding, cerebrovascular events, and sepsis. Among adult patients, mortality at 1-year was 33.3% among the CHD cohort versus 22.1% in the non-CHD cohort. Adult CHD patients had higher hazards of mortality within the first year after MCS implantation (HR 1.98 95% CI 1.35-2.91, p < 0.001) and bleeding events (sdHR 2.10, 95% CI 1.40-3.16, p < 0.001) compared with non-CHD patients. Both associations remained significant after accounting for multiple mediators. Among paediatric patients, mortality at 1-year was 22.1% in the CHD cohort versus 17.3% in the non-CHD cohort (HR 1.39 95% CI 0.83-2.32, p = 0.213). Adult and paediatric patients with CHD on MCS have higher adverse event risk compared with non-CHD MCS patients, though children did not have greater risk of mortality. As the number of CHD patients requiring advanced heart failure management continues to grow, these findings can enhance informed decision-making.

Temporal Analysis in Outcomes of Long-Term Mechanical Circulatory Support: Retrospective Study.

Mechanical assist device indications have changed in recent years. Reduced incidence of complications, better survival, and the third generation of mechanical support devices contributed to this change. In this single-center study, we focused on two time periods that are characterized by the use of different types of mechanical support devices, different patient characteristics, and change in the indications. The data were processed from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). We retrospectively defined two time intervals to reflect changes in ventricular assist device technology (period 1: 2007-2015; period 2: 2016-20222). A total of 181 patients underwent left ventricular assist device implantation. Device utilization was the following: HeartMate II = 52 (76.4%) and HeartWare = 16 (23.6%) in period 1 and HeartMate II = 2 (1.8%), HeartMate 3 = 70 (61:9%), HeartWare = 29 (25.7%), SynCardia TAH = 10 (8.8%), and BerlinHeart EXCOR = 2 (1.8%) in period 2. The outcomes of the time intervals were analyzed and evaluated. Survival was significantly higher during the second time period. Multivariate analysis revealed that age and bypass pump time are independent predictors of mortality. Idiopathic cardiomyopathy, bypass time, and the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) score are independent predictors of adverse events. Furthermore, the first period was noted to be at an increased risk of the following adverse events: pump thrombosis, gastrointestinal bleeding, and bleeding events. Despite the higher risk profile of the patients and persistent challenges, during the second period, there was a significant decrease in mortality and morbidity. The use of the HeartMate 3 device may have contributed to this result.

Efficacy of levosimendan infusion in patients undergoing a left ventricular assist device implant in a propensity score matched analysis of the EUROMACS registry-the Euro LEVO-LVAD study.

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. 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. 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. 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 European Registry for Patients with Mechanical Circulatory Support (EUROMACS): third Paediatric (Paedi-EUROMACS) report.

A third paediatric report has been generated from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). The purpose of EUROMACS, which is operated by the European Association for Cardio-Thoracic Surgery, is to gather data related to durable mechanical circulatory support for scientific purposes and to publish reports with respect to the course of mechanical circulatory support therapy. Since the first report issued, efforts to increase compliance and participation have been extended. Additionally, the data provided the opportunity to analyse patients of younger age and lower weight. Participating hospitals contributed pre-, peri- and long-term postoperative data on mechanical circulatory support implants to the registry. Data for all implants in paediatric patients (<19 years of age) performed from 1 January 2000 to 31 December 2020 were analysed. This report includes updates of patient characteristics, implant frequency, outcome (including mortality rates, transplants and recovery rates) as well as adverse events including neurological dysfunction, device malfunction, major infection and bleeding. Twenty-five hospitals contributed 537 registered implants in 480 patients. The most frequent aetiology of heart failure was any form of cardiomyopathy (59%), followed by congenital heart disease and myocarditis (15% and 14%, respectively). Competing outcomes analysis revealed that a total of 86% survived to transplant or recovery or are ongoing; at the 2-year follow-up examination, 21.9% died while on support. At 12 months, 45.1% received transplants, 7.5% were weaned from their device and 20.8% died. The 3-month adverse events rate was 1.59 per patient-year for device malfunction including pump exchange, 0.7 for major bleeding, 0.78 for major infection and 0.71 for neurological events. The overall survival rate was 79.2% at 12 months following ventricular assist device implant. The comparison of survival rates of the early and later eras shows no significant difference. A focus on specific subgroups showed that survival was less in patients of younger age (<1 year of age; P = 0.01) and lower weight (<20 kg; P = 0.015). Transplant rates at 6 months continue to be low (33.2%).

Predictive capabilities of the European registry for patients with mechanical circulatory support right-sided heart failure risk score after left ventricular assist device implantation

The prediction of right heart failure (RHF) after left ventricular assist device (LVAD) implantation remains a challenge. Recently, risk scores were derived from analysis of the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) data, the EUROMACS-RHF, and the modified postoperative EUROMACS-RHF. The authors assessed the performance characteristics of these 2 risk score formulations in a continuous-flow LVAD cohort at their institution. A retrospective, observational study. At a tertiary-care academic medical center. Adult patients who underwent durable LVAD implantation between 2015 and 2018. None MEASUREMENTS AND MAIN RESULTS: Early post-LVAD RHF was defined as follows: (1) need for right ventricular assist device, or (2) inotropic or inhaled pulmonary vasodilator support for ≥14 postoperative days. The authors used logistic regression and examined receiver operating characteristic (ROC) curves to evaluate the ability of the 2 risk scores to distinguish between outcome groups. A total of 207 patients met the inclusion criteria. Of the patients, 16% developed RHF (33/207). The EUROMACS-RHF score was not predictive of RHF in the authors' cohort (odds ratio [OR] 1.25; 95% CI [0.99-1.60]; p=0.06), but the postoperative EUROMACS-RHF CPB score was significantly associated (OR 1.38; 95% CI [1.03-1.89]; p=0.03). The scores had similar ROC curves, with weak discriminatory performance: 0.601 (95% CI [0.509-0.692]) and 0.599 (95% CI [0.505-0.693]) for EUROMACS-RHF and postoperative EUROMACS-RHF, respectively. In the authors' single-center retrospective analysis, the EUROMACS-RHF risk score did not predict early RHF. An optimized risk score for the prediction of RHF after LVAD implantation remains an urgent unmet need.

Impact of Concomitant Cardiac Valvular Surgery During Implantation of Continuous-Flow Left Ventricular Assist Devices: A European Registry for Patients with Mechanical Circulatory Support (EUROMACS) Analysis

<h3>Purpose</h3> 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. <h3>Methods</h3> Between 2006 and 2018, 2760 continuous-flow LVAD patients were identified. Of these, 533 underwent a CCP during the LVAD implant. <h3>Results</h3> 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<b>)</b>. 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). <h3>Conclusion</h3> 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 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.

Comparative analysis of LVAD patients in regard of ischaemic or idiopathic cardiomyopathy: A propensity-score analysis of EUROMACS data.

Despite recent advances in management of patients with advanced heart failure, mortality remains high. Aim of this study was to compare impact of different aetiology of ischaemic and idiopathic cardiomyopathy on early outcomes and long-term survival of patients after left ventricular assist device implantation. European Registry for Patients with Mechanical Circulatory Support (EUROMACS) gathers clinical data and follow-up parameters of LVAD recipients. Patients enrolled in the EUROMACS registry with primary diagnosis of either ischaemic (n = 1190) or idiopathic (n = 812) cardiomyopathy were included. Primary Endpoints were early mortality as well as long-term survival. Secondary endpoint were major postoperative adverse events, such as need for rethoracotomy. Additionally, a propensity-score matching analysis was performed for patients with ischaemic (n = 509) and idiopathic (n = 509) cardiomyopathy. In terms of basic demographics and baseline parameters the two groups significantly differed as expected before propensity-score matching due to different aetiology of cardiomyopathy. Seven-day (52 (4.4%) versus 18 (2.2%); p = 0.009), 30-day (153 (12.9%) versus 73 (9.0%); p = 0.008) and in-hospital mortality (253 (19.7%) versus 123 (15.1%); p = 0.009) were significantly lower in the idiopathic cardiomyopathy group compared to the ischaemic cardiomyopathy group, whereas after propensity-score matching 30-day (p = 0.169) was comparable and in-hospital mortality (p = 0.051) was almost significant. Kaplan-Meier survival analysis revealed no significant difference in regard of long-term survival after propensity-score matching (Breslow-test p = 0.161 and LogRank-test p = 0.113). Though patients with ischaemic and idiopathic cardiomyopathy suffer from different cardiomyopathy aetiologies, 30-day-mortality and long-term survival of both groups were similar leading to the conclusion that covariates predominately influence mortality and survival of ischaemic and idiopathic cardiomyopathies.

Impact of concomitant cardiac valvular surgery during implantation of continuous-flow left ventricular assist devices: A European registry for patients with mechanical circulatory support (EUROMACS) analysis.

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. Between 2006 and 2018, 2760 continuous-flow LVAD patients were identified. Of these, 533 underwent a CCP during the LVAD implant. 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). 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.

Gender differences in psychosocial and clinical characteristics in the European Registry for Patients with Mechanical Circulatory Support

BackgroundNot much is known about psychosocial characteristics of men and women receiving continuous flow left ventricular assist devices (CF LVAD). ObjectiveTo investigate gender differences in clinical and psychosocial (demographic, behavioral, psychological) characteristics in CF LVAD recipients. MethodsWe analyzed European Registry for Patients with Mechanical Circulatory Support (EUROMACS) data (N=2395, 16.8% women; 2011 to 2017) and compared pre-implant characteristics in men and women intended for bridge-to-transplant (BTT) or destination therapy (DT). ResultsWomen were underrepresented [DT (n=61): 13.4%; BTT (n=341): 17.6%]. They were more likely to be divorced/separated, widowed, in unstable clinical condition, and non-working (DT only), but less likely to be smokers, to have ischemic cardiomyopathy or diabetes, and younger (BTT only) than men. Missing data were abundant, especially those that reflect psychological characteristics (>87%). ConclusionGender differences were noted, some specific to device strategy. Improved collection of psychosocial characteristics is warranted to elucidate their relationship to future prognosis.

The outcome of patients with peripartum cardiomyopathy and consecutive implantation of a left ventricular assist device.

Peripartum cardiomyopathy (PPCM) is a form of systolic heart failure occurring toward the end of pregnancy or in the period after delivery. Lack of myocardial recovery or therapy-refractory cardiogenic shock are rare complications and left ventricular assist device (LVAD) systems might be used as a life-saving option. The aim of this study was to investigate outcomes of PPCM patients supported with LVAD, registered in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). All patients registered in EUROMACS with a primary diagnosis of PPCM were included in this study. Demographic, preoperative, intraoperative, postoperative, and follow-up data were collected and patients analysed concerning their outcome after initiation of LVAD therapy. Between May 2011 and September 2018, 16 patients with PPCM and consecutive LVAD implantation were enrolled into EUROMACS. The median age of the patient population was 31 (26;41) years with a mean left ventricular ejection fraction (LV-EF) of 15% ± 6%. In-hospital mortality after LVAD implantation was 6% (n = 1). One-year mortality accounted for 13% (n = 2). Six patients (40%) were transplanted with a median support time of 769 (193;1529) days. Weaning of LVAD support due to ventricular recovery was feasible in 3 (20%) patients. In patients with severe PPCM, LVAD therapy is associated with considerably low in-hospital mortality, potentially allowing bridging to heart transplantation, or left ventricular recovery. Therefore, durable mechanical support should be considered as a treatment option in this, by nature, young and often otherwise healthy patient population.

Pediatric ventricular assist device registries: update and perspectives in the era of miniaturized continuous-flow pumps.

The success of ventricular assist devices (VADs) in the treatment of end-stage heart failure in the adult population has led to industrial innovation in VAD design, focusing on miniaturization and the reduction of complications. A byproduct of these innovations was that newer generation devices could have clinical applications in the pediatric population. Over the last decade, VAD usage in the pediatric population has increased dramatically, and the newer generation continuous flow (CF) devices have begun to supplant the older, pulsatile flow (PF) devices, formerly the sole option for ventricular assist in the pediatric population. However, despite the increase in VAD implants in the pediatric population, patient numbers remain low, and the need to share data between pediatric VAD centers has become that much more important for the continued growth of VAD programs worldwide. The creation of pediatric VAD registries, such as the Pediatric Registry for Mechanical Circulatory Support (PediMACS), the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) and the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) has enabled the collection of aggregate data from VAD centers worldwide, and provides a valuable resource for clinicians and programs, as more and more pediatric heart failure patients are considered candidates for VAD therapy.

Propensity score-based analysis of long-term follow-up in patients supported with durable centrifugal left ventricular assist devices: the EUROMACS analysis.

The HeartWare HVAD (HW) and the HeartMate3 (HM3) are presently the most commonly used continuous-flow left ventricular assist devices worldwide. We compared the outcomes of patients supported with either of these 2 devices based on data from the EUROMACS (European Registry for Patients with Mechanical Circulatory Support). A retrospective analysis of the survival and complications profile in propensity score-matched adult patients enrolled in the EUROMACS between 01 January 2016 and 01 September 2020 and supported with either an HW or HM3. Matching included demographic parameters, severity of cardiogenic shock and risk-modifying end-organ parameters that impact long-term survival. Survival on device and major postoperative adverse events were analysed. Following 1:1 propensity score matching, each group consisted of 361 patients. Patients were well balanced (<0.1 standardized mean difference). The median follow-up was similar in both groups [396 (interquartile range (IQR) 112-771) days for HW and 376 (IQR 100-816) days for HM3]. The 2-year survival was similar in both groups [HW: 61% 95% confidence interval (CI) (56-67%) vs HM3: 68% 95% CI (63-73%) (stratified hazard ratio for mortality: 1.13 95% CI (0.83-1.54), P = 0.435].The cumulative incidence for combined major adverse events and unexpected readmissions was similar in both groups [subdistribution hazard ratio (SHR) 1.0 (0.84-1.21), P = 0.96]. Patients in the HW group demonstrated a higher risk of device malfunction [SHR 2.44 (1.45-3.71), P < 0.001], neurological dysfunction [SHR 1.29 (1.02-1.61), P = 0.032] and intracranial bleeding [SHR 1.76 (1.13-2.70), P = 0.012]. Mid-term survival in both groups was similar in a propensity-matched analysis. The risk of device malfunction, neurological dysfunction and intracranial bleeding was significantly higher in HW patients.

Clinical impact and 'natural' course of uncorrected tricuspid regurgitation after implantation of a left ventricular assist device: an analysis of the European Registry for Patients with Mechanical Circulatory Support (EUROMACS).

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. METHODSThe 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.RESULTSA 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.CONCLUSIONSUncorrected 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.

Prediction of right ventricular failure after continuous flow left ventricular assist device implantation.

Right ventricular failure (RVF) is a major cause of morbidity and mortality after left ventricular assist device (LVAD) implantation. Prediction of this clinical situation in LVAD patients with different clinical scores is still an enigma. The aim of this study is to analyze the predictive power of clinical parameters and risk scores and their combinations to discriminate RVF after LVAD implantation. A retrospective, single center review of 71 patients who underwent continuous flow-LVAD implantation between September 2013 and September 2016, was performed. RVF was defined as need for RVAD and/or administration of inotropic agents more than 14 days after LVAD implantation. Patients with and without RVF were divided into two groups and predictive power of the nine parameters (tricuspid annular plane systolic excursion (TAPSE), Michigan score, Pennsylvania score, central venous pressure/pulmonary artery wedge pressure ratio (CVP/PCWP), and right ventricular stroke work index, pulmonary artery pulsatility index, CRITT score, ALMA score, European registry for patients with mechanical circulatory support (EUROMACS) right heart failure model and their combinations were analyzed to predict postoperative RVF. Of 71 patients, 21 had RVF after implantation. For the variables that can be used to discriminate between RVF and non-RVF groups, the diagnostic performance of the best cut-off points and tests was obtained using receiver operating characteristic (ROC) curve analysis. Discrimination analysis was performed to determine the combinations of tests. For all single risk scores and parameters; the area under the ROC curve (AUC) was below 0.7 which is considered to be a poor level of discrimination except EUROMACS score (AUC: 0.789, P < .001) and CRITT score (AUC: 0.739, P = .004). AUC for the combination of TAPSE and Pennsylvania score was 0.722, combination of Michigan and Pennsylvania scores represented AUC of 0.732 in the analysis. The combination of TAPSE + Pennsylvania score was found to have the highest sensitivity (85%), whereas TAPSE + Michigan score + CVP/PCWP appeared as the most specific (97%) combination. EUROMACS and CRITT scores predict RVF with high discrimination after LVAD implantation. Although, no other single test predicts RVF ideally, combination of risk scores and parameters discriminate RVF acceptably.

Heart failure etiology and risk of right heart failure in adult left ventricular assist device support: the European Registry for Patients with Mechanical Circulatory Support (EUROMACS)

Objectives: Development of right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation remains a leading cause of perioperative morbidity, end-organ dysfunction and mortality. The objective of this study was to investigate whether the etiology of HF (ischemic HF versus non-ischemic HF) affects the risk of RVF within admission for LVAD implantation and during long-term follow-up. Methods: Between January 2011 and June 27, 2018, 3536 patients were prospectively enrolled into EUROMACS registry. Adult patients (>18 years) who received a first time LVAD were included. When excluding patients with congenital, restrictive, hypertrophic, valvular cardiomyopathies, and myocarditis the total population consisted of 2404 patients. Results: The total cohort consists of 2404 patients. Mean age were 55 years and predominantly male sex [2024 (84.2%)]. At the time of LVAD implantation 1355 (56.4%) patients had ischemic HF and 1049 (43.6%) patients had non-ischemic HF. The incidence of RVF was significantly increased in the non-ischemic HF group in the adjusted model (p = .026). The relative risk difference for RVF in patients with non-ischemic HF was in the adjusted model increased by an absolute value of 5.1% (95% CI: 0.61–9.6). In the ischemic HF group 76 patients (13.4%) developed late RVF and 62 patients (14.8%) in the non-ischemic HF group (p = .56). No differences in occurrence of RVF between HF etiology was observed after 2 and 4 years of follow-up, respectively (crude: p = .25, adjusted (sex and age) p = .2 and crude: p = .59, adjusted (sex and age) p = .44). Conclusions: Patients with non-ischemic HF undergoing LVAD had an increased incidence of early RVF compared to patients with ischemic HF in a large European population. During follow-up after discharge 14% patients developed RVF. We recommend HF etiology to be considered in identifying patients who are at risk for postoperative RVF after LVAD implantation.

The European Registry for Patients with Mechanical CirculatorySupport (EUROMACS): second EUROMACS Paediatric (Paedi-EUROMACS) report.

A second paediatric report has been generated from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). The purpose of EUROMACS, which is operated by the European Association for Cardio-Thoracic Surgery, is to gather data related to durable mechanical circulatory support for scientific purposes and to publish reports with respect to the course of mechanical circulatory support therapy. Since the first report issued, efforts to increase compliance and participation have been extended. Additionally, the data provided the opportunity to analyse patients of younger age and lower weight. Participating hospitals contributed pre-, peri- and long-term postoperative data on mechanical circulatory support implants to the registry. Data for all implants in paediatric patients (≤19 years of age) performed from 1 January 2000 to 1 July 2019 were analysed. This report includes updates of patient characteristics, implant frequency, outcome (including mortality rates, transplants and recovery rates) as well as adverse events including neurological dysfunction, device malfunction, major infection and bleeding. Twenty-nine hospitals contributed 398 registered implants in 353 patients (150 female, 203 male) to the registry. The most frequent aetiology of heart failure was any form of cardiomyopathy (61%), followed by congenital heart disease and myocarditis (16.4% and 16.1%, respectively). Competing outcomes analysis revealed that a total of 80% survived to transplant or recovery or are ongoing; at the 2-year follow-up examination, 20% died while on support. At 12 months, 46.7% received transplants, 8.7% were weaned from their device and 18.5% died. The 3-month adverse events rate was 1.69 per patient-year for device malfunction including pump exchange, 0.48 for major bleeding, 0.64 for major infection and 0.78 for neurological events. The overall survival rate was 81.5% at 12 months following ventricular assist device implant. The comparison of survival rates of the early and later eras shows no significant difference. A focus on specific subgroups showed that survival was less in patients of younger age (<1 year of age) (P = 0.01) and lower weight (<20 kg) (P = 0.015). Transplant rates at 6 months continue to be low (33.2%) The fact that the EUROMACS registry is embedded within the European Association for Cardio-Thoracic Surgery Quality Improvement Programme offers opportunities to focus on improving outcomes.

Corrigendum to: The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): first EUROMACS Paediatric (Paedi-EUROMACS) report [Eur J Cardiothorac Surg 2018;54:800-8

Corrigendum to: The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): first EUROMACS Paediatric (Paedi-EUROMACS) report [Eur J Cardiothorac Surg 2018;54:800-8

Clinical, Social, and Behavioral Characteristics at Time of Implant in European Registry for Patients with Mechanical Circulatory Support (EUROMACS): Associations with Gender and Device Strategy

The role of gender in the prognosis of continuous flow left ventricular assist device (CF-LVAD) recipients is poorly understood. We present gender differences in clinical, social, and behavioral characteristics by intended device strategy at time of implant, which may influence gender-specific outcomes. Analyses were based on data from 2,395 adult patients (16.8% women) enrolled in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) and implanted with a primary CF-LVAD as bridge-to-transplant (BTT; n = 1,939, 17.6% female) or destination therapy (DT; n = 456, 13.4% female) between January 2011 to December 2017. Analyses of variance (ANOVAs) and Multinomial regression analyses were performed to test associations between gender, device strategy and baseline characteristics. Overall, compared to men, women were younger, less likely to be smoking, to be diagnosed with ischemic cardiomyopathy and diabetes; however, they were more likely to be in unstable clinical condition (INTERMACS profile 1 and 2), to have smaller BSA, to be divorced, separated or widowed. Men and women also differed within the intended device strategies. Especially women intended for BTT, were less likely to report alcohol abuse (χ2(1) = 6.23, p < .013). And especially women intended for DT, were less likely to work for an income (χ2(1) = 4.37, p < .036). Stratifying outcome research by gender and device strategy as well as considering social and behavioral health risks (in addition to clinical parameters) may help to elucidate the role of gender in outcomes post CF-LVAD implant.

Concomitant Cardiac Procedures during Implantation of Long-Term Continuous-Flow LVADs: A European Registry for Patients with Mechanical Circulatory Support (EUROMACS) Analysis

There are still discordant data on the effect of concomitant cardiac procedures (CCPs) performed during left ventricular assist device (LVAD) implantation. By investigating on the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) dataset, we identified 2760 patients (pts) who underwent continuous-flow (CF) long-term LVAD implantation. LVAD implantation was associated with a single CCP in 533 pts (19.3%). A propensity score (PS) matching (LVAD pts, n=481 vs. LVAD+CCP pts, n=481) analysis has been perfomed. Intensive care unit (ICU) stay (20.9 vs. 25.5 days, p=0.019) and major bleeding requiring rethoracotomy (4.1% vs. 7.2%, p=0.027) resulted to be more frequent in LVAD+CPP cohort. Hospital mortality (17.4% vs. 22.2%, p=0.063) resulted to be comparable. Only coronary artery bypass grafting (p=0.041, OR 2.03, CI 1.03-4.02) did impact negatively. Extremes of body mass index (BMI), preoperative poor haemodynamics, dependance on inotropes infusion and extracorporeal life support (ECLS) resulted to be risk factors, after adjustment for baseline characteristics. During the mid- to long-term postoperative period, LVAD+CCP population showed higher incidence of bleeding (6.9% vs. 10.8%, p=0.031) and infectious adverse events (9.6% vs. 15.4%, p=0.022), respectively. Follow-up mortality (22.5% vs. 20.3%, p=0.432) resulted to be comparable. Valve surgery concomitant with LVAD implant seemed not to be associated with poor clinical outcomes (p=0.785). Mitral valve repair resulted to be protective in the long-term period (p=0.041), while tricuspid valve repair did not have any influence (p=0.108). No differences were observed by Kaplan-Meier survival analysis in the two cohorts (log-rank p=0.81, PS matched). In summary, performance of CCPs may not increase peri-operative mortality and type of concomitant surgery addressed should be properly weighted. Mid- to long-term survival is not influenced by CCPs. This, however, remains a delicate population to be strictly monitored and homogeneously managed to preserve satisfactory outcomes.

Course and Clinical Impact of Tricuspid Regurgitation after LVAD Implantation: An Analysis of the EUROMACS Registry

Purpose This study explores the course of uncorrected tricuspid regurgitation (TR) after left ventricular assist device (LVAD) implantation and the clinical impact of pre-LVAD TR on 30-day and late mortality. Methods The European Registry for Patients with Mechanical Circulatory Support (EUROMACS) was used to identify adult patients undergoing LVAD implant with TR, but without concomitant tricuspid valve surgery. Multivariable regression models were used to assess the impact of TR on both early and late mortality. It was hypothesized that TR was associated with early mortality via well-known risk factors. Therefore, mediation analysis was conducted using structural equation models. Generalized mixed-models were used to model post-LVAD TR course over time. Results In total 2496 procedures were included. A higher pre-LVAD TR grade was associated with worse pre-LVAD right ventricular function (RVF) (OR 2,96 95%CI[2,18-4,01], p Conclusion Pre-LVAD TR is positively correlated with worse pre-LVAD RVF, and is associated with worse outcome. TR can decrease without intervention after LVAD implant. Therefore, patient selection for concomitant tricuspid valve surgery should not solely be based on TR grade.