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Aims: Right ventricular failure after left ventricular assist device (LVAD) implantation is a major concern that remains challenging to predict. We sought to investigate the relationship between preoperative pulmonary artery pulsatility index (PAPi) and mortality after LVAD implantation., Methods and Results: A retrospective analysis of the ASSIST-ICD multicentre registry allowed the assessment of PAPi before LVAD according to the formula [(systolic pulmonary artery pressure - diastolic pulmonary artery pressure)/central venous pressure]. The primary endpoint was survival at 3 months, according to the threshold value of PAPi determined by the receiver operating characteristic (ROC) curve. A multivariate analysis including demographic, echographic, haemodynamic, and biological variables was performed to identify predictive factors for 2 year mortality. One hundred seventeen patients were included from 2007 to 2021. The mean age was 58.45 years (±13.16), with 15.4% of women (sex ratio 5.5). A total of 53.4% were implanted as bridge to transplant and 43.1% as destination therapy. Post-operative right ventricular failure was observed in 57 patients (48.7%), with no significant difference between survivors and non-survivors at 1 month (odds ratio 1.59, P = 0.30). The median PAPi for the whole study population was 2.83 [interquartile range 1.63-4.69]. The threshold value of PAPi determined by the ROC curve was 2.84. Patients with PAPi ≥ 2.84 had a higher survival rate at 3 months [PAPi < 2.84: 58.1% [46.3-72.8%] vs. PAPi ≥ 2.84: 89.1% [81.1-97.7%], hazard ratio (HR) 0.08 [0.02-0.28], P < 0.01], with no significant difference after 3 months (HR 0.67 [0.17-2.67], P = 0.57). Other predictors of 2 year mortality were systemic hypertension (HR 4.22 [1.49-11.97], P < 0.01) and diabetes mellitus (HR 4.90 [1.83-13.14], P < 0.01). LVAD implantation as bridge to transplant (HR 0.18 [0.04-0.74], P = 0.02) and heart transplantation (HR 0.02 [0.00-0.18], P < 0.01) were associated with a higher survival rate at 2 years., Conclusions: Preoperative PAPi < 2.84 was associated with a higher risk of early mortality after LVAD implantation without impacting 2 year outcomes among survivors., (© 2024 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Aims: Despite regularly updated guidelines, there is still a delay in referral of advanced heart failure patients to mechanical circulatory support and transplant centres. We aimed to analyse characteristics and outcome of non-inotrope-dependent patients implanted with a left ventricular assist device (LVAD)., Methods and Results: The ASSIST-ICD registry collected LVAD data in 19 centres in France between February 2006 and December 2016. We used data of patients in Interagency Registry for Mechanically Assisted Circulatory Support Classes 4-7. The primary endpoint was survival analysis. Predictors of mortality were searched with multivariable analyses. A total of 303 patients (mean age 61.0 ± 9.9 years, male sex 86.8%) were included in the present analysis. Ischaemic cardiomyopathy was the leading heart failure aetiology (64%), and bridge to transplantation was the main implantation strategy (56.1%). The overall likelihood of being alive while on LVAD support or having a transplant at 1, 2, 3, and 5 years was 66%, 61.7%, 58.7%, and 55.1%, respectively. Age [hazard ratio (HR) 1.03, 95% confidence interval (CI) 1.00-1.05; P = 0.02], a concomitant procedure (HR 2.32, 95% CI 1.52-3.53; P < 0.0001), and temporary mechanical right ventricular support during LVAD implantation (HR 2.94, 95% CI 1.49-5.77; P = 0.002) were the only independent variables associated with mortality. Heart failure medications before or after LVAD implantation were not associated with survival., Conclusion: Ambulatory heart failure patients displayed unsatisfactory survival rates after LVAD implantation. A better selection of patients who can benefit from LVAD may help improving outcomes., (© 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Objectives: Our goal was to provide a picture of left ventricular assist device (LVAD) activity in France between 2007 and 2016 based on the multicentric ASSIST-ICD registry., Methods: We retrospectively collected 136 variables including in-hospital data, follow-up survival rates and adverse events from 671 LVAD recipients at 20 out of 24 LVAD implant centres in France. The average follow-up time was 1.2 years (standard deviation: 1.4); the total follow-up time was 807.5 patient-years., Results: The included devices were the HeartMate II®, HeartWare LVAS® or Jarvik 2000®. The overall likelihood of being alive while on LVAD support or having a transplant (primary end point) at 1, 2, 3 and 5 years postimplantation was 65.2%, 59.7%, 55.9% and 47.7%, respectively, given a cumulative incidence of 29.2% of receiving a transplant at year 5. At implantation, 21.5% of patients were on extracorporeal life support. The overall rate of cardiogenic shock at implantation was 53%. The major complications were driveline infection (26.1%), pump pocket or cannula infection (12.6%), LVAD thrombosis (12.2%), ischaemic (12.8%) or haemorrhagic stroke (5.4%; all strokes 18.2%), non-cerebral haemorrhage (9.1%) and LVAD exchange (5.2%). The primary end point (survival) was stratified by age at surgery and by the type of device used, with inference from baseline profiles. The primary end point combined with an absence of complications (secondary end point) was also stratified by device type., Conclusions: The ASSIST-ICD registry provides a real-life picture of LVAD use in 20 of the 24 implant centres in France. Despite older average age and a higher proportion of patients chosen for destination therapy, survival rates improved compared to those in previous national registry results. This LVAD registry contrasts with other international registries because patients with implants have more severe disease, and the national policy for graft attribution is distinct. We recommend referring patients for LVAD earlier and suggest a discussion of the optimal timing of a transplant for bridged patients (more dismal results after the second year of support?)., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Patient-specific anatomy may influence the final intraventricular positioning of inflow cannula in left ventricular assist device (LVAD) recipients. An association exists between such positioning and clinical outcomes (specifically, orientation toward the interventricular septum has negative prognostic implications). Alternative commercially available LVADs are characterized by markedly different design, with potential consequences on intrathoracic fitting among individual patients., Material and Methods: A cohort of 13 LVAD recipients (either HeartMate II-group A or Jarvik 2000 Flowmaker-group B) was evaluated. On postoperative computed tomography scans, we reconstructed the implanted LVAD (semiautomatic segmentation), defined the target mitral orifice (3D Slicer software), and built a coordinate system to quantify the coaxiality of the cannula with the mitral valve axis (angles φ and θ, expressed as percentage variation from the ideal value φ = θ = 0°)., Results: Group A presented significantly greater average percentage variation of the φ angle (significantly greater orientation of the intraventricular cannula toward the interventricular septum; 33.2% ± 32.1% versus 1.9% ± 0.9%, P = 0.001). Group A presented significantly greater average percentage variation of the θ angle (52.7% ± 23.6% versus 14.5% ± 6.3%, P = 0.013)., Conclusions: The device assessed in group B showed in the present series better average coaxiality with the mitral orifice. Such finding is related with its design (total intraventricular placement) and interaction with thoracic structures. The present method is being integrated in the development of LVAD virtual implantation tools and may help physicians in patient-specific selection among alternative devices., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Current recommendations of antithrombotic therapy for HeartMate II (HMII) patients include the use of both an anticoagulant and an antiplatelet agent. Because bleeding is still the most frequent adverse event, the TRACE (STudy of Reduced Anti-Coagulation/Anti-platelet Therapy in Patients with the HeartMatE II) study was initiated to evaluate the incidence of adverse events in HMII patients on reduced antithrombotic (RT) therapy., Methods: HMII patients (n = 101) from nine centers were enrolled in the European arm of TRACE and were managed on a single anticoagulant (vitamin K antagonist) with no antiplatelet agents. An analysis of bleeding and thrombotic adverse events from all 101 patients with 2-year follow-up after initiation of RT therapy is reported here., Results: Median age was 56 years (range, 18 to 72 years), 93% were men, 70% had an Interagency Registry for Mechanically Assisted Circulatory Support profile 1 to 3, and 82% received the HMII as a bridge to transplantation. Ninety-two percent were placed on RT therapy as a center standard of care or due to physician preference and 6% as a response to bleeding. Median HMII support duration on RT therapy was 25 months (range, 1 to 93 months). Median international normalized ratio was 2.31 [quartile 1 to quartile 3: 2.07 to 2.60]. At 2 years, freedom from bleeding, ischemic stroke, hemorrhagic stroke, and pump thrombosis after initiation of RT therapy was 81% ± 6%, 96% ± 2%, 94% ± 3%, and 94% ± 3%, respectively., Conclusions: The 2-year analysis of the observational European TRACE study suggests that managing HMII patients with a vitamin K antagonist with a target international normalized ratio of 2.3 without antiplatelet therapy may help to reduce the incidence of major bleeding without increasing the risk of thromboembolic events, including ischemic stroke and pump thrombosis., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Mechanical and hemodynamic factors are among the determinants of patient-device interaction and early-term and long-term outcomes in left ventricular assist device (LVAD) recipients., Material and Methods: We are currently developing computer simulation tools aimed at (1) analyze the intrathoracic and intracavitary positioning of LVADs after implantation and establish correlation with clinical outcomes; (2) assist surgeons in the choice of device and of left ventricular coring site for optimized intrathoracic placement and function; and (3) facilitate the planning of less-invasive LVAD implantation. A virtual representation of LVAD (mesh device component) was created through cone-beam computed tomography and semiautomatic segmentation. A modular framework software (CamiTK, Grenoble, France) was used to create a three-dimensional representation of patients' computed tomography (CT) scan and incorporate the mesh device component for virtual implantation., Results: Device reconstruction was included into a dedicated software with the purposes of virtual implantation, based on the preoperative CT scan of surgical candidates., Conclusions: We present herein the first digital reconstruction of the novel HeartMate 3 LVAD. Virtual implantation on the basis of preoperative CT scan is feasible within a user-friendly interactive software. Future studies will be focused on correlation with clinical variables., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Left ventricular assist devices (LVAD) are increasingly used for long-term mechanical circulatory support and are effective in improving survival and quality-of-life of patient with advanced heart failure. Nonetheless, they are associated with significant early and late morbidity rates (including pump thrombosis, thromboembolic events, and pump dysfunction). These complications are at least partially associated with suboptimal pump positioning. Currently, we are missing tools to further improve the positioning of LVAD devices in a patient-specific fashion., Methods and Evaluation of the Hypothesis: We hypothesized that the analysis of the implanted device in patients presenting selected LVAD-related complications through segmentation and three-dimensional reconstruction of CT scans may provide patient-specific information into mechanical factors contributing to pump dysfunction and thromboembolic events, with potential to guide preventive interventions against development of new complications. We also hypothesized that preoperative virtual implantation and computer-assisted surgery in candidates to LVAD implantation may help in the customization of device positioning, with potential to minimize severe complications. The hypothesis was evaluated in a multidisciplinary fashion (cardiac surgeons, biomedical engineers and biomedical images processing experts). CT scans of 14 LVAD recipients were reconstructed through semi-automatic segmentation (including the whole heart, the implanted device and the chest wall). A coordinate system was built to quantify the coaxiality of the LVAD apical cannula with the mitral annulus. Patients were stratified into Group 1 (presenting complications such as thromboembolic events, pump dysfunction or thrombosis) and Group 2 (no complications). Group 1 patients presented significantly greater average rotation of the apical cannula towards the interventricular septum (p=0.015), although no difference was observed in terms of average rotation towards the anterior or posterior left ventricular wall., Conclusions: Several patient-specific factors (including left ventricular morphology and chest wall conflict with the device after wound closure) may influence the effectiveness and safety of LVAD therapy, but they are difficultly managed through the current implantation techniques. We suggest that the clinical results of LVAD treatment can be improved through preoperative virtual implantation and computer-assisted surgery (in order to guide device selection, exact site of left ventricular wall coring site). Given these preliminary results, we are examining larger patient datasets in order to further test the hypothesis. Dedicated tools for virtual implantation are currently under development., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Faced with the growing number of people suffering from heart failure, mechanical circulatory support techniques have developed in order to improve the survival of patients not responding to optimal medical treatment. Rennes university hospital therefore decided to create a VAD (Ventricular Assist Device) nurse coordinator position to improve and optimise the quality of the follow-up of these patients. She plays a crucial role in the care of the patient, before, during and after hospitalisation.

Objective: To present the analyzed results on mechanical circulatory support (MCS) collected over a 7-year period, from 2000 to 2006, in France., Methods: A cohort of 520 patients was analyzed. Mean age was 43.7 ± 13.6 years. The main causes of cardiac failure were ischemic cardiomyopathy (39%), idiopathic dilated cardiomyopathy (41.3%), or myocarditis (6.4%). Bridge to transplantation was indicated in 87.8% of patients, bridge to recovery in 9%, while destination therapy was proposed in 3.2% of patients., Results: For patients in cardiogenic shock or advanced heart failure undergoing device implantation as bridge to transplantation or recovery (n=458), overall mortality was 39% (n=179). The main causes of mortality under MCS were multi-organ failure (MOF) (57.4%), neurological events (14.1%), or infections (11.9%). Heart transplantation was performed in 249 (54.3%) patients. The main causes of death following heart transplantation were primary graft failure (22.4%), MOF (14.3%), neurological event (14.3%), or infection (10.2%). Long-term survival in transplanted patients was 75 ± 2.8% at 1 year and 66 ± 3.4% at 5 years., Conclusions: MCS is an essential therapeutic tool to save the life of young patients with cardiogenic shock or advanced cardiac failure. Early MCS implantation and the availability of a device that is adapted to the patient's clinical status are prerequisites for reducing overall mortality rates., (Copyright © 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.)

Recently, the third generation of partial electromagnetic artificial hearts appeared, which are a real technological advancement. These new ventricular assist devices are small, implantable, silent and increase the patients' quality of life in comparison with the electromechanical pump of second generation. Their clinical efficiency is at least as good as the second generation in light of the first experiences reported on animals and human beings. Their use as a bridge to transplant and especially as a destination therapy should increase in the coming years as they represent an answer to the health problem, which is the increasing population of patients in heart failure.

The impact of heart failure on patients and economical burden on health insurance resources is increasing. Cardiac transplantation is still the primary treatment for patients who are in end stage heart failure. The development of artificial hearts (total and partial) was implemented by the discrepancy between the scarcity of available donors and the importance of waiting lists for cardiac transplantation. The technical progresses achieved since the first works of Kolff in 1957 now allow these patients to have their circulation restored and go home to wait for their transplantation. The encouraging results of the artificial heart and the miniaturization of these devices allow them to be considered as a possible destination therapy for patients not eligible for cardiac transplantation.