Platelet Function Testing to Guide Cangrelor Dosing in Patients with Temporary Mechanical Circulatory Support or as a Bridge to Procedure.

Cangrelor is a rapid-acting, intravenous P2Y12 inhibitor that can be used in patients after percutaneous coronary intervention who require mechanical circulatory support or as a bridge to procedure. We retrospectively reviewed adult patients who received platelet function testing (PFT) with the VerifyNow P2Y12 assay while on cangrelor from March 2021 through November 2022. All patients were initiated on 0.75 mcg/kg/min of cangrelor with P2Y12 reaction unit (PRU) values collected 12-24 h after initiation. Cangrelor doses were adjusted per protocol to maintain PRU values of 85-208. A total of 42 patients were included. Thirty-eight patients (90.5%) required temporary mechanical circulatory support while on cangrelor, and 4 patients (9.5%) received cangrelor as a bridge to procedure. The median cangrelor maintenance dose was 0.5 (interquartile range [IQR]: 0.375-0.75) mcg/kg/min, and the median time in therapeutic range with a PRU value between 85 and 208 was 66.6% (IQR: 39.6%-100%). No patients experienced stent thrombosis. A composite major adverse cardiovascular event occurred in 4 patients (9.5%), and major bleeding occurred in 16 patients (38.1%). Compared to empiric cangrelor dosing of 0.75 mcg/kg/min, PFT-guided cangrelor dose adjustment was associated with a median drug cost savings of $1605.60 (IQR: $0-4281.56). Utilizing PFT with cangrelor may allow for lower, individualized dosing while preventing stent thrombosis.

[Temporary circulatory assistance by Impella™ in interventional cardiology: Observational study and medico-economic assessment after four years of use]. / Assistance circulatoire temporaire par Impella™ en cardiologie interventionnelle : étude observationnelle et bilan médicoéconomique après quatre ans d'utilisation.

OBJECTIVES: During life-threatening emergencies or risky cardiologic interventions, pharmacology can be limited and the use of appropriate medical devices is then necessary. The Impella™ catheter, CP and 2.5, has been referenced for the exclusive use of the interventional cardiology technical platform at Hôpital Nord (AP-HM) in the absence of rapid access to the Extracorporeal Circulation unit. It is a temporary mechanical circulatory support device mainly indicated in refractory cardiogenic shock and coronary angioplasty at high risk of hemodynamic instability. The objective of this study, observational and retrospective, is to carry out a clinical and economic assessment linked to the use of this device over a period of four years (2017-2020). METHODS: The criteria relating to the 71 patients (51 Impella™ CP and 20 Impella™ 2.5) and their clinical evolution as well as the costs and valuation of the stays were determined. RESULTS: In particular, the Impella™ CP enabled myocardial recovery in 18 out of 51 patients and it was an intermediary in the context of heavier care for 11 patients. The balance between expenditure and valuation shows a deficit of -819,937 euros over the study period, with however a probable margin for improvement. CONCLUSIONS: The Impella™ is of clinical interest under very specific conditions. Its high cost and the absence of inclusion on the list of reimbursements in addition to Homogeneous Groups of Stays represent a significant financial burden for health care establishments. Thus, optimizing the rating of future stays is a necessity.

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.

Ultrasound Assessment in Cardiogenic Shock Weaning: A Review of the State of the Art.

Cardiogenic shock (CS) is associated with a high in-hospital mortality despite the achieved advances in diagnosis and management. Invasive mechanical ventilation and circulatory support constitute the highest step in cardiogenic shock therapy. Once established, taking the decision of weaning from such support is challenging. Intensive care unit (ICU) bedside echocardiography provides noninvasive, immediate, and low-cost monitoring of hemodynamic parameters such as cardiac output, filling pressure, structural disease, congestion status, and device functioning. Supplemented by an ultrasound of the lung and diaphragm, it is able to provide valuable information about signs suggesting a weaning failure. The aim of this article was to review the state of the art taking into account current evidence and knowledge on ICU bedside ultrasound for the evaluation of weaning from mechanical ventilation and circulatory support in cardiogenic shock.

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.

Long-term mortality and costs following use of Impella® for mechanical circulatory support: a population-based cohort study.

PURPOSE: The Impella® device is a form of mechanical circulatory support (MCS) used in critically ill adults with cardiogenic shock. We sought to evaluate short- and long-term outcomes following the use of Impella, including mortality, healthcare utilization, and costs. METHODS: Population-based, retrospective cohort study of adult patients (≥ 16 yr) receiving Impella in Ontario, Canada (1 April 2012-31March 2019). We captured outcomes through linkage to health administrative databases. The primary outcome was mortality during hospitalization. Secondary outcomes included mortality at 30 days, 90 days, and one year following Impella insertion. We analyzed health system costs in Canadian dollars in the year following the date of the index admission, including the costs of inpatient admission. RESULTS: We included 162 patients. Mean (standard deviation) age was 59.2 (14.5) yr, and 73.5% of patients were male. Median [interquartile range (IQR)] time to Impella insertion from date of hospital admission was 2 [1-9] days. In-hospital mortality was 56.8%, and a significant proportion of patients were bridged to a ventricular assist device (67.9%). Mortality at one year was 61.7%. Among hospital survivors, only 38.6% were discharged home independently. Median [IQR] total cost in the year following admission among all patients was $88,397 [32,718-225,628], of which $66,529 [22,789-183,165] was attributed to inpatient care. CONCLUSIONS: In-hospital mortality among patients with cardiogenic shock receiving Impella is high, but with minimal increase at one year. While Impella patients accrued substantial costs, these largely reflected inpatient costs, and not costs incurred following hospital discharge.

RéSUMé: OBJECTIF: Le dispositif Impella® est un système d'assistance circulatoire mécanique utilisé chez les adultes en état critique souffrant d'un choc cardiogénique. Nous avons souhaité évaluer les issues à court et à long terme liées à l'utilisation de l'Impella, notamment la mortalité, l'utilisation des soins de santé et les coûts. MéTHODE: Nous avons réalisé une étude de cohorte rétrospective basée sur une population de patients adultes (≥ 16 ans) recevant un Impella en Ontario, au Canada (1er avril 2012­31 mars 2019). Nous avons saisi les données pertinentes à nos critères d'évaluation en créant des liens avec les bases de données administratives de santé. Le critère d'évaluation principal était la mortalité pendant l'hospitalisation. Les critères d'évaluation secondaires comportaient la mortalité à 30 jours, 90 jours et un an après l'insertion de l'Impella. Nous avons analysé les coûts pour le système de santé en dollars canadiens au cours de l'année suivant la date d'admission initiale, notamment les coûts hospitaliers. RéSULTATS: Nous avons inclus 162 patients. L'âge moyen (écart type) était de 59,2 (14,5) ans, et 73,5 % des patients étaient des hommes. Le temps médian [écart interquartile (ÉIQ)] jusqu'à insertion de l'Impella depuis l'admission à l'hôpital était de 2 [1­9] jours. La mortalité hospitalière était de 56,8 %, et un dispositif d'assistance ventriculaire a été implanté chez une importante proportion de patients (67,9 %). La mortalité à un an était de 61,7 %. Parmi les survivants hospitaliers, seuls 38,6 % ont reçu leur congé pour un retour indépendant à la maison. Le coût total médian [ÉIQ] pour l'année suivant l'admission parmi tous les patients était de 88 397 $ [32 718 ­ 225 628 $], dont 66 259 $ [22 789 ­ 183 165 $] étaient attribuables aux soins hospitaliers. CONCLUSION: La mortalité hospitalière parmi les patients en choc cardiogénique chez lesquels un Impella est installé est élevée, mais on n'observe qu'une augmentation minimale à un an. Alors que les patients ayant reçu un Impella ont engendré des coûts importants, ces coûts reflètent principalement les coûts hospitaliers et non les coûts encourus après le congé de l'hôpital.

The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support.

BACKGROUND: Impella was approved for mechanical circulatory support (MCS) in 2008, but large-scale, real-world data on its use are lacking. Our objective was to describe trends and variations in Impella use, clinical outcomes, and costs across US hospitals in patients undergoing percutaneous coronary intervention (PCI) treated with MCS (Impella or intra-aortic balloon pump). METHODS: From the Premier Healthcare Database, we analyzed 48 306 patients undergoing PCI with MCS at 432 hospitals between January 2004 and December 2016. Association analyses were performed at 3 levels: time period, hospital, and patient. Hierarchical models with propensity adjustment were used for association analyses. We examined trends and variations in the proportion of Impella use, and associated clinical outcomes (in-hospital mortality, bleeding requiring transfusion, acute kidney injury, stroke, length of stay, and hospital costs). RESULTS: Among patients undergoing PCI treated with MCS, 4782 (9.9%) received Impella; its use increased over time, reaching 31.9% of MCS in 2016. There was wide variation in Impella use across hospitals (>5-fold variation). Specifically, among patients receiving Impella, there was a wide variation in outcomes of bleeding (>2.5-fold variation), and death, acute kidney injury, and stroke (all ≈1.5-fold variation). Adverse outcomes and costs were higher in the Impella era (years 2008-2016) versus the pre-Impella era (years 2004-2007). Hospitals with higher Impella use had higher rates of adverse outcomes and costs. After adjustment for the propensity score, and accounting for clustering of patients by hospitals, Impella use was associated with death: odds ratio, 1.24 (95% CI, 1.13-1.36); bleeding: odds ratio, 1.10 (95% CI, 1.00-1.21); and stroke: odds ratio, 1.34 (95% CI, 1.18-1.53), although a similar, nonsignificant result was observed for acute kidney injury: odds ratio, 1.08 (95% CI, 1.00-1.17). CONCLUSIONS: Impella use is rapidly increasing among patients undergoing PCI treated with MCS, with marked variability in its use and associated outcomes. Although unmeasured confounding cannot be ruled out, when analyzed by time periods, or at the hospital level or the patient level, Impella use was associated with higher rates of adverse events and costs. More data are needed to define the appropriate role of MCS in patients undergoing PCI.

Advances in temporary mechanical support for treatment of cardiogenic shock.

Mechanical circulatory support devices are the mainstay of treatment for severe cardiogenic shock refractory to pharmacologic therapy. Their evolution over the past few decades has been remarkable with a common theme of developing reliable, less bulky and more easily percutaneously implantable devices. The goal of this article is to review existing devices and advances in technology and provide insight into direction of further research and evolution of mechanical circulatory support devices for temporary support.

Hemodynamic support with percutaneous devices in patients with heart failure.

The use of surgically implanted durable mechanical circulatory support (MCS) in high-risk patients with heart failure is declining and short-term, nondurable MCS device use is growing. Percutaneously delivered MCS options for advanced heart failure include the intra-aortic balloon pump, Impella axial flow catheter, TandemHeart centrifugal pump, and venoarterial extracorporeal membrane oxygenation. Nondurable MCS devices have unique implantation characteristics and hemodynamic effects. Algorithms and guidelines for optimal nondurable MCS device selection do not exist. Emerging technologies and applications will address the need for improved left ventricular unloading using lower-profile devices, longer-term ambulatory support, and the potential for myocardial recovery.