Capillary refill time assessment after fluid challenge in patients on venoarterial extracorporeal membrane oxygenation: A retrospective study.

BACKGROUND: Monitoring fluid therapy is challenging in patients assisted with Veno-arterial ECMO. The aim of our study was to evaluate the usefulness of capillary refill time to assess the response to fluid challenge in patients assisted with VA-ECMO. METHODS: Retrospective monocentric study in a cardiac surgery ICU. We assess fluid responsiveness after a fluid challenge in patients on VA-ECMO. We recorded capillary refill time before and after fluid challenge and the evolution of global hemodynamic parameters. RESULTS: A total of 27 patients were included. The main indications for VA-ECMO were post-cardiotomy cardiogenic shock (44%). Thirteen patients (42%) were responders and 14 non-responders (58%). In the responder group, the index CRT decreased significantly (1.7 [1.5; 2.1] vs. 1.2 [1; 1.3] s; p = 0.01), whereas it remained stable in the non-responder group (1.4 [1.1; 2.5] vs. 1.6 [0.9; 1.9] s; p = 0.22). Diagnosis performance of CRT variation to assess response after fluid challenge shows an AUC of 0.68 (p = 0.10) with a sensitivity of 79% [95% CI, 52-92] and a specificity of 69% [95% CI, 42-87], with a threshold at 23%. CONCLUSION: In patients treated with VA-ECMO index capillary refill time is a reliable tool to assesses fluid responsiveness. SPECIALTY: Critical care, Cardiac surgery, ECMO.

One-Year Mental and Physical Health Assessment in Survivors after Extracorporeal Membrane Oxygenation for COVID-19-related Acute Respiratory Distress Syndrome.

Rationale: Long-term outcomes of patients with coronavirus disease (COVID-19)-related acute respiratory distress syndrome treated with extracorporeal membrane oxygenation (ECMO) are unknown. Objectives: To assess physical examination, pulmonary function tests, anxiety, depression, post-traumatic stress disorder and quality of life at 6 and 12 months after ECMO onset. Methods: Multicenter, prospective study in patients who received ECMO for COVID-19 acute respiratory distress syndrome from March to June 2020 and survived hospital discharge. Measurements and Main Results: Of 80 eligible patients, 62 were enrolled in seven French ICUs. ECMO and invasive mechanical ventilation duration were 18 (11-25) and 36 (27-62) days, respectively. All were alive, but only 19/50 (38%) returned to work and 13/42 (31%) had recovered a normal sex drive at 1 year. Pulmonary function tests were almost normal at 6 months, except for DlCO, which was still impaired at 12 months. Mental health, role-emotional, and role-physical were the most impaired domain compared with patients receiving ECMO who did not have COVID-19. One year after ICU admission, 19/43 (44%) patients had significant anxiety, 18/43 (42%) had depression symptoms, and 21/50 (42%) were at risk for post-traumatic stress disorders. Conclusions: Despite the partial recovery of the lung function tests at 1 year, the physical and psychological function of this population remains impaired. Based on the comparison with long-term follow-up of patients receiving ECMO who did not have COVID-19, poor mental and physical health may be more related to COVID-19 than to ECMO in itself, although this needs confirmation.

Budget Impact Analysis of Impella CP® Utilization in the Management of Cardiogenic Shock in France: A Health Economic Analysis.

INTRODUCTION: Early detection and treatment of cardiogenic shock (CS) is crucial to avoid irreparable multiorgan damage and mortality. Impella CP® is a novel temporary mechanical circulatory support (MCS) device associated with greater hemodynamic support and significantly fewer device-related complications compared with other MCS devices, e.g., intra-aortic balloon pumps (IABP) and venoarterial extracorporeal membrane oxygenation (VA-ECMO). The present study evaluated the budget impact of introducing Impella CP versus IABP and VA-ECMO in patients with CS following an acute myocardial infarction (MI) in France. METHODS: A budget impact model was developed to compare the cost of introducing Impella CP with continuing IABP and VA-ECMO treatment from a Mandatory Health Insurance (MHI) perspective in France over a 5-year time horizon, with 700 patients with refractory CS assumed to be eligible for treatment per year. Costs associated with Impella CP and device-related complications for all interventions were captured and clinical input data were based on published sources. Scenario analyses were performed around key parameters. RESULTS: Introducing Impella CP was associated with cumulative cost savings of EUR 2.7 million over 5 years, versus continuing current clinical practice with IABP and VA-ECMO. Cost savings were achieved in every year of the analysis and driven by the lower incidence of device-related complications with Impella CP, with estimated 5-year cost savings of EUR 22.4 million due to avoidance of complications. Total cost savings of more than EUR 250,000 were projected in the first year of the analysis, which increased as the market share of Impella CP was increased. Scenario analyses indicated that the findings of the analysis were robust. CONCLUSION: Treatment with Impella CP in adult patients aged less than 75 years in a state of refractory CS following an MI was projected to lead to substantial cost savings from an MHI perspective in France, compared with continuing current clinical practice.

Budget Impact Associated with the Introduction of the Impella 5.0® Mechanical Circulatory Support Device for Cardiogenic Shock in France.

AIM: Cardiogenic shock (CS), if not diagnosed and treated rapidly, can lead to irreversible multiorgan damage and death. An economic analysis was conducted to determine the budget impact of the introduction of Impella 5.0®, a mechanical circulatory support (MCS) device that directly unloads the left ventricle, into clinical practice in patients with left ventricular CS in France. METHODS: A budget impact model was developed to compare the cost of Impella 5.0 with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) from the perspective of the French national healthcare insurer. Costs associated with Impella 5.0, plus complication-related costs for VA-ECMO or Impella 5.0 from 2019 were included and clinical input data relating to complication rates and time spent on device were sourced from published literature. Extensive scenario and one-way deterministic sensitivity analyses were performed to explore the influence of uncertainty around key input parameters. RESULTS: Over a time horizon of 5 years, the introduction of Impella 5.0 was associated with cumulative savings of EUR 4.3 million. The results were driven by the lower risk of device-related complications associated with Impella 5.0. Savings were apparent from Year 1 onwards, with savings in excess of EUR 375,000 projected in Year 1 alone. On a per-patient level, in Year 1, estimated savings with the introduction of Impella 5.0 totaled EUR 616 per patient. Sensitivity analyses showed that the findings of the analysis were robust. CONCLUSION: The Impella 5.0 device was associated with cumulative cost savings in excess of EUR 4 million over a 5-year period compared with current practice. Projected savings were driven by a lower rate of device-related complications with Impella 5.0 compared with VA-ECMO.

Management of end-stage heart failure patients with or without ventricular assist device: an observational comparison of clinical and economic outcomes.

OBJECTIVES: Heart transplantation (HT) and ventricular assist devices (VAD) for the management of end-stage heart failure have not been directly compared. We compare the outcomes and use of resources with these 2 strategies in 2 European countries with different allocation systems. METHODS: We studied 83 patients managed by VAD as the first option in Bad Oeynhausen, Germany (Group I) and 141 managed with either HT or medical therapy, as the first option, in Paris, France (Group II). The primary end-point was 2-year survival. Kaplan-Meier analyses were performed after the application of propensity score weights to mitigate the effects of non-random group assignment. The secondary end-points were resource utilization and costs. Subgroup analyses were performed for patients undergoing HT and patients treated with inotropes at the enrolment time. RESULTS: The Group I patients were more severely ill and haemodynamically compromised, and 28% subsequently underwent HT vs 55% primary HT in Group II, P < 0.001. The adjusted probability of survival was 44% in Group I vs 70% in Group II, P <0.0001. The mean cumulated 2-year costs were €281 361 ± 156 223 in Group I and €47 638 ± 35 061 in Group II, P < 0.0001. Among patients who underwent HT, the adjusted probability of survival in Group I (n = 23) versus Group II (n = 78) was 76% versus 68%, respectively (0.09), though it differed in the inotrope-treated subgroups (77% in Group I vs 67% in Group II, P = 0.04). CONCLUSIONS: HT should remain the first option for end-stage heart failure patients, associated with improved outcomes and better cost-effectiveness profile. VAD devices represent an option when transplant is not possible or when patient presentation is not optimal.

Assessment of potential heart donors: A statement from the French heart transplant community.

Assessment of potential donors is an essential part of heart transplantation. Despite the shortage of donor hearts, donor heart procurement from brain-dead organ donors remains low in France, which may be explained by the increasing proportion of high-risk donors, as well as the mismatch between donor assessment and the transplant team's expectations. Improving donor and donor heart assessment is essential to improve the low utilization rate of available donor hearts without increasing post-transplant recipient mortality. This document provides information to practitioners involved in brain-dead donor management, evaluation and selection, concerning the place of medical history, electrocardiography, cardiac imaging, biomarkers and haemodynamic and arrhythmia assessment in the characterization of potential heart donors.

Between-center disparities in access to heart transplantation in France: contribution of candidate and center factors - A comprehensive cohort study.

Transplantation represents the last option for patients with advanced heart failure. We assessed between-center disparities in access to heart transplantation in France 1 year after registration and evaluated the contribution of factors to these disparities. Adults (n = 2347) registered on the French national waiting list between January 1, 2010, and December 31, 2014, in the 23 transplant centers were included. Associations between candidate and transplant center characteristics and access to transplantation were assessed by proportional hazards frailty models. Candidate blood groups O and A, sensitization, and body mass index ≥30 kg/m2 were independently associated with lower access to transplantation, while female gender, severity of heart failure, and high serum bilirubin levels were independently associated with greater access to transplantation. Center factors significantly associated with access to transplantation were heart donation rate in the donation service area, proportion of high-urgency candidates among listed patients, and donor heart offer decline rate. Between-center variability in access to transplantation increased by 5% after adjustment for candidate factors and decreased by 57% after adjustment for center factors. After adjustment for candidate and center factors, five centers were still outside of normal variability. These findings will be taken into account in the future French heart allocation system.