No abstract

Right ventricular failure (RVF) exposes ventricular assist device (VAD) recipients to a high risk of death, but its management has not yet been standardized. We report three separate management strategies used for VAD recipients that present with RVF at a single center: 1) Thoratec paracorporeal biventricular VAD implantation, 2) left ventricular assist device (LVAD) implantation with temporary CentriMag right ventricular assist device (RVAD), and 3) LVAD combined with inotropic therapy. We retrospectively compared the preoperative data, the clinical outcomes, and the rates of adverse events in 84 biventricular assist device (BiVAD) recipients and 89 LVAD recipients presenting with postoperative RVF (57 were treated with a temporary RVAD and 32 were managed medically). Risk factors for death were analyzed. The BiVAD recipients were significantly younger, more critically ill at the time of device implantation, and required extracorporeal membrane oxygenation, an intraaortic balloon pump, mechanical ventilation, inotropes, or cardiopulmonary resuscitation significantly more often (at the time of device implant) than the LVAD recipients with RVF. The 6 month mortality was comparable in the two groups: 44 BiVAD patients (52%) and 38 LVAD patients (43%). Age, previous cardiac surgery, low platelet count, increased creatinine levels, the use of preoperative mechanical ventilation, and the need for a temporary RVAD were associated with 6 month mortality. The occurrence of RVF at the time of device implantation is a severe situation; it is associated with excess mortality, even if it is managed using a BiVAD or a LVAD with a temporary RVAD, probably because of the high preoperative risk profiles of the patients. In all cases, RVF must be managed quickly.

This retrospective study reviews our results regarding the long-term support in pediatric patients using two ventricular assist systems between January 2008 and April 2014. We implanted the Berlin Heart EXCOR in 29 patients (median age 3.4 years [interquartile range (IQR) 0.2-16.5], median weight 13 kg [IQR 4.2-67.2]). Twenty-two patients (75.8%) received a left ventricular assist device. Three patients (10.3%) had single-ventricle physiology. One patient (3.4%) had mechanical mitral valve prosthesis. The HeartWare System was implanted in nine patients. The median age was 15.6 years (IQR 12.2-17.9), and the median weight was 54.9 kg (IQR 27.7-66). In the Berlin Heart group, the median support time was 65 days (IQR 4-619), with 3647 days of cardiac support. Nineteen patients (65.5%) were transplanted, six patients (20.7%) recovered, one patient (3.4%) is on support, and three patients (10.3%) died on support. Survival rate was 89.7%. Fourteen blood pumps had been exchanged. Four patients (13.8%) had local signs of infection, and three patients (10.3%) had neurological complications. In the HeartWare group, the median support time was 180 days (IQR 1-1124), with 2839 days of cardiac support. Four patients (44.4%) had local signs of infection, and three (33.3%) had neurological complications. Eight patients (88.9%) have been transplanted, and one patient (11.1%) died on support. Survival rate was 88.9%. Excellent survival is possible after long-term mechanical circulatory support in patients with two- and single-ventricle physiology with a low rate of adverse events.

IntroductionSelf-management (SM) may facilitate patient participation and involvement to become active and knowledgeable partners in the care of complex chronic conditions such as ventricular assist device (VAD) therapy. The ‘SM model for patients on VAD support’ will serve to distinguish between SM components, and will guide the development, implementation and evaluation of an evidence-based curriculum.Methods and analysisThis is a 3-phase, multicentre study. In phase 1, a prevalence study will be performed. Phase 2 aims to develop an evidence-based, interprofessional curriculum for SM support for VAD patients. In phase 3, a non-blinded block-randomised controlled trial (RCT), allocation ratio 1:1, intervention group superiority, with an unblinded multifacetted intervention with assessments before (T1) and after (T2) the intervention, and two follow-up assessments at three (T3), and 12 (T4) months after VAD implantation, will be performed. The curriculum guides the intervention in the RCT. Patient recruitment will consider centre-related volume: power analyses require 384 patients for phase 1, and 142 patients for phase 3.Ethics and disseminationEthical considerations will be continuously taken into account and approved by the institutional review boards. Central ethical review board approval has been obtained by the Albert-Ludwigs University Freiburg. This study will be performed in concordance with the Declaration of Helsinki and the European data protection law. Publications will exclusively report aggregated data and will be distributed in the scientific community, and patient support groups. Report languages will be German and English.Trial registration numbersNCT04234230 and NCT04526964; Pre-results.

Background The clinical profile of left ventricular assist device (LVAD) candidates is rapidly changing, with increasing proportion of patients in more stable clinical conditions. However, early postoperative right ventricular failure (eRVF) is still one of the cornerstones associated with increased mortality and the preoperative recognition of associated risk factors remains challenging. The aim of this study was to identify predictive parameters for eRVF after LVAD implantation in patients with preoperative intermediate Intermacs (InM) risk profile 3‐5. Methods Preoperative laboratory, echocardiography, and right heart catheterization data collected from 80 patients with InM profile 3‐5 before LVAD implantation were retrospectively tested with respect to their ability to predict the risk for eRVF after the implantation of a continuous‐flow LVAD. Results Preoperative higher bilirubin and blood urea nitrogen (BUN) levels, higher Model for End‐stage Liver Disease score, lower estimated glomerular filtration rate, and higher central venous pressure to pulmonary capillary wedge pressure ratio (CVP/PCWP) were associated to higher risk of eRVF. Regarding the echocardiographic assessment, higher end diastolic linear dimensions of the RV, higher basal end diastolic RV linear dimension to LV ratio, severe tricuspid regurgitation, lower tricuspid annular plane systolic excursion, and lower RV fractional area contraction identified patients with higher risk for eRVF. In the multivariable analysis, a CVP/CPWP > 0.55 (odds ratio [OR]: 4, 95% confidence interval [CII]: 1.4‐11.8;P = .01) and BUN > 44.5 mg/dL (OR: 6.6, 95% CI: 1.51‐23; P = .011) independently predicted the risk of eRVF. Conclusion Preoperative BUN > 44.5 mg/dL and CVP/PCWP > 0.55 are associated to an increased risk of eRVF following LVAD implantation in intermediate InM patients.