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Cost-Effectiveness of a Small Intrapericardial Centrifugal Left Ventricular Assist Device.

ABSTRACT: There is limited data on the cost-effectiveness of continuous-flow left ventricular assist devices (LVAD) in the United States particularly for the bridge-to-transplant indication. Our objective is to study the cost-effectiveness of a small intrapericardial centrifugal LVAD compared with medical management (MM) and subsequent heart transplantation using the respective clinical trial data. We developed a Markov economic framework. Clinical inputs for the LVAD arm were based on prospective trials employing the HeartWare centrifugal-flow ventricular assist device system. To better assess survival in the MM arm, and in the absence of contemporary trials randomizing patients to LVAD and MM, estimates from the Seattle Heart Failure Model were used. Costs inputs were calculated based on Medicare claim analyses and when appropriate prior published literature. Time horizon was lifetime. Costs and benefits were appropriately discounted at 3% per year. The deterministic cost-effectiveness analyses resulted in $69,768 per Quality Adjusted Life Year and $56,538 per Life Year for the bridge-to-transplant indication and $102,587 per Quality Adjusted Life Year and $87,327 per Life Year for destination therapy. These outcomes signify a substantial improvement compared with prior studies and re-open the discussion around the cost-effectiveness of LVADs.

SUBMITTER: Silvestry SC

PROVIDER: S-EPMC7386874 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Cost-Effectiveness of Thoracotomy Approach for the Implantation of a Centrifugal Left Ventricular Assist Device.

Project description:This study reports the first analysis regarding cost-effectiveness of left ventricular assist device (LVAD) implantation via thoracotomy. Cost-effectiveness of LVADs implanted via the traditional surgical approach of sternotomy has been improved through the years because of technological advances, along with understanding the importance of patient selection and postimplant management have on positively affecting outcomes. Given the positive clinical outcomes of the thoracotomy approach, we seek to study the cost-effectiveness of a centrifugal LVAD via this less invasive approach. We developed a Markov model. Survival and quality of life inputs (QALY) for the LVAD arm were based on data from the LATERAL clinical trial. For the Medical Management arm, survival was derived from the Seattle Heart Failure Model. The heart transplant probability was derived from INTERMACS. Survival after heart transplantation used International Society for Heart and Lung Transplantation data. Cost inputs were calculated based on Medicare data and past literature. The incremental cost-effectiveness ratio was found to be $64,632 per quality adjusted life year and $57,891 per life year in the bridge to transplant indication. These results demonstrate further improvement in the overall cost-effectiveness of LVAD therapy and confirm implantation of LVADs via a less invasive approach as being cost-effective.

| S-EPMC7386860 | biostudies-literature

Fully magnetically centrifugal left ventricular assist device and long-term outcomes: the ELEVATE registry.

Project description:Background and aimsHeartMate 3 (HM3) is a fully magnetically levitated continuous flow left ventricular assist device, which received CE marking in 2015. The ELEVATE Registry was initiated to collect real-world outcomes in patients treated with HM3 post-CE Mark approval.MethodsA total of 540 subjects implanted at 26 centres between March 2015 and February 2017 were included in this registry. Of these, 463 received the device as a primary implant (primary implant cohort, PIC), 19 as a pump exchange (pump exchange cohort), and in 58 patients, only anonymized survival data were collected (anonymized cohort, AC). Patients in the PIC contributed to the baseline demographics, survival, adverse events, quality of life (QoL) (EuroQoL-5 Dimensions-5 Levels visual analogue scale), and functional capacity (6 min walk distance) assessments, while patients in the AC contributed only to survival.ResultsPrimary implant cohort patients had a mean age of 56 years and were predominantly male (89%) with 48% ischaemic aetiology. The majority of subjects was designated bridge to transplant (66%) and had INTERMACS Profiles 1-3 (70%). At baseline, the subjects had poor functional capacity (104 ± 140 m) and impaired QoL (35 ± 19 points). The overall survival rate of the PIC was 63.3% and survival free of stroke was 58.1% at 5 years. Significant improvements in functional capacity and QoL were observed and maintained for 5 years (301 ± 131 m and 64 ± 20 points, respectively).ConclusionsReal-world data from the ELEVATE registry demonstrate an overall survival rate for primary implants of 63.3%. In the PIC, reductions in adverse events for patients in the extended follow-up and improved QoL and functional capacity were observed at 5 years in this patient population with advanced heart failure.

| S-EPMC10959573 | biostudies-literature

Simple Felt-Plug Closure Technique for Minimally Invasive Removal of a Centrifugal-Flow Left Ventricular Assist Device.

Project description:As the indications for implanting left ventricular assist devices have expanded, some patients are qualifying for device removal after myocardial recovery. Whereas explantation has been described for previous generations of devices, no standard procedures have been developed. Removal of centrifugal-flow devices has created the need for a plug to seal the apical ventriculotomy after pump removal. However, no commercially available products are available in the United States. We used a novel technique to fashion a plug from Teflon felt and a Dacron graft to enable minimally invasive explantation of a current-generation centrifugal-flow device in a 33-year-old woman.

| S-EPMC7819444 | biostudies-literature

Outcomes of Hospitalizations for Cardiogenic Shock at Left Ventricular Assist Device Versus Non-Left Ventricular Assist Device Centers.

Project description:Background Cardiogenic shock (CS) is a complex syndrome associated with high morbidity and mortality. In recent years, many US hospitals have formed multidisciplinary shock teams capable of rapid diagnosis and triage. Because of preexisting collaborative systems of care, hospitals with left ventricular assist device (LVAD) programs may also represent "centers of excellence" for CS care. However, the outcomes of patients with CS at LVAD centers have not been previously evaluated. Methods and Results Patients with CS were identified in the 2012 to 2014 National Inpatient Sample. Clinical characteristics, revascularization rates, and use of mechanical circulatory support were analyzed in LVAD versus non-LVAD centers. The association between hospital type and in-hospital mortality was examined using multivariable logistic regression models. Of 272 075 hospitalizations, 26.0% were in LVAD centers. CS attributable to causes other than acute myocardial infarction represented most cases. In-hospital mortality was lower in LVAD centers (38.9% versus 43.3%; P<0.001). In multivariable analysis, the odds of mortality remained significantly lower for hospitalizations in LVAD centers (odds ratio, 0.89; P<0.001). In patients with CS secondary to acute myocardial infarction, revascularization rates were similar between LVAD and non-LVAD centers. The use of intra-aortic balloon pump (18.7% versus 18.8%) and Impella/TandemHeart (2.6% versus 1.9%) was similar between hospital types, whereas extracorporeal membrane oxygenation was used more frequently in LVAD centers (4.3% versus 0.2%; P<0.001). Conclusions Risk-adjusted mortality was lower in patients with CS who were hospitalized at LVAD centers. These centers likely represent specialized, shock team capable institutions across the country that may be best suited to manage patients with CS.

| S-EPMC7763759 | biostudies-literature

Outcomes following left ventricular assist device exchange.

Project description:INTRODUCTION:Left ventricular assist device (LVAD) exchange has been historically associated with a significant risk of morbidity and mortality. It is unknown, however, whether these outcomes have improved. We aimed to compare clinical outcomes following LVAD exchange to those following initial LVAD implant in a contemporary patient cohort. METHODS:A total of 115 LVAD patients were enrolled between 2014 and 2017 and followed for 1 year. Of these, 15 patients (54.5?±?13.3 years old, 87% male) underwent LVAD exchange at 277 (IQR 191-597) days following LVAD implantation and 100 patients (57.5?±?12.3 years old, 76% male) did not undergo an LVAD exchange (non-exchange group). RESULTS:One-year survival rate following LVAD exchange tended to be higher than the non-exchange patients (93% vs 76%, P = .15). Readmission rates for each comorbidity did not significantly differ between the two groups (P?>?.05 for all) except for the higher rate of pump thrombosis in the LVAD exchange group (P?<?.05). DISCUSSION:LVAD exchange cohorts seem to have comparable clinical outcome with the non-exchange cohorts. CONCLUSION:LVAD exchange might be an increasingly appropriate therapeutic option for the management of pump thrombosis, although careful monitoring for recurrent pump thrombosis is required.

| S-EPMC7135913 | biostudies-literature

Effect of left ventricular assist device support on congestive heart failure patients

Project description:Molecular analysis of the effect left ventricular assist device (LVAD) support has on congestive heart failure patients. Keywords = Congestive heart failure, left ventricular assist device, eNOS, gene, dimethylarginine dimethylaminohydrolase Keywords: other

2003-09-01 | GSE430 | GEO

Outcomes after stroke complicating left ventricular assist device.

Project description:Stroke is one of the leading complications during continuous flow-left ventricular assist device (CF-LVAD) support. Risk factors have been well described, although less is known regarding treatment and outcomes. We present a large single-center experience on stroke outcome and transplant eligibility by stroke sub-type and severity in CF-LVAD patients.Between January 1, 2008, and April 1, 2015, 301 patients underwent CF-LVAD (266 HeartMate II [HM I], Thoratec Corp, Pleasanton, CA; 35 HeartWare [HVAD], HeartWare International Inc, Framingham, MA). Stroke was defined as a focal neurologic deficit with abnormal neuroimaging. Intracerebral hemorrhage (ICH) definition excluded sub-dural hematoma and hemorrhagic conversion of an ischemic stroke (IS). Treatment in IS included intra-arterial embolectomy when appropriate; treatment in ICH included reversal of coagulopathy. Stroke severity was measured using the National Institutes of Health Stroke Scale (NIHSS). Outcomes were in-hospital mortality and transplant status.Stroke occurred in 40 patients: 8 ICH (4 HM II, 4 HVAD) and 32 IS (26 HM II, 6 HVAD). Among 8 ICH patients, there were 4 deaths (50%), with NIHSS of 18.8 ± 13.7 vs 1.8 ± 1.7 in survivors (p = 0.049). Among 32 IS patients, 12 had hemorrhagic conversion and 5 were treated with intra-arterial embolectomy. There were 9 deaths (28%), with NIHSS of 16.2 ± 10.8 vs 7.0 ± 7.6 in survivors (p = 0.011). Among the 32 IS patients, 12 underwent transplant, and 1 is awaiting transplant. No ICH patients received a transplant.In-hospital mortality after stroke is significantly affected by the initial neurologic impairment. Patients with IS appear to benefit the most from in-hospital treatment and often make sufficient recovery to be able to progress to transplant.

| S-EPMC4983489 | biostudies-literature

Left Ventricular Assist Device Infections: A Systematic Review.

Project description:Left ventricular assist devices (LVADs) are becoming a more frequent life-support intervention. Gaining an understanding of risk factors for infection and management strategies is important for treating these patients. We conducted a systematic review and meta-analysis of studies describing infections in continuous-flow LVADs. We evaluated incidence, risk factors, associated microorganisms, and outcomes by type of device and patient characteristics. Our search identified 90 distinct studies that reported LVAD infections and outcomes. Younger age and higher body mass index were associated with higher rates of LVAD infections. Driveline infections were the most common infection reported and the easiest to treat with fewest long-term consequences. Bloodstream infections were not reported as often, but they were associated with stroke and mortality. Treatment strategies varied and did not show a consistent best approach. LVAD infections are a significant cause of morbidity and mortality in LVAD patients. Most research comes from secondary analyses of other LVAD studies. The lack of infection-oriented research leaves several areas understudied. In particular, bloodstream infections in this population merit further research. Providers need more research studies to make evidence-based decisions about the prevention and treatment of LVAD infections.

| S-EPMC5920737 | biostudies-literature

Left ventricular assist device bioinformatics identify possible hubgenes and regulatory networks involved in the myocardium of patients with left ventricular assist device.

Project description:ObjectiveThe aim of this study was to clarify the changes of myocardial gene expression profile after left ventricular assist device (LVAD) implantation and the related molecular biological significance.MethodsA thorough bioinformatic analysis to evaluate the changes in gene expression profile in patients pre-LVAD and post-LVAD was conducted. Four relevant gene expression datasets-GSE430, GSE974, GSE21610, and GSE52601 from Gene Expression Omnibus (GEO) database were downloaded. Analysis of GEO2R, Gene Ontology (GO), protein-protein interaction (PPI) were used to determine differentially expressed genes (DEGs) and their function, respectively.ResultsA total of 37 DEGs were identified, including 26 down-regulated and 11 up-regulated genes. The molecular function of DEGs were enriched in "cytokine activity," "neurotransmitter binding," "receptor ligand activity." The gene set enrichment analysis (GSEA) revealed an overall marked increase of neutrophil degranulation signaling, closely correlated with the G protein coupled receptor (GPCR)-ligand binding process after LVAD assistance. 16 hubgenes in these DEGs were further selected and the biological process involved is mainly related to positive regulation of leukocyte chemotaxis mediated by chemokines.ConclusionInflammatory signaling pathway is crucial for the pathophysiology after LVAD implantation. Chemokines mediate cardiac inflammatory response and tissue remodeling after LVAD implantation through GPCR-ligand binding.

| S-EPMC9558819 | biostudies-literature

Comparison of the Hemocompatibility of an Axial and a Centrifugal Left Ventricular Assist Device in an In Vitro Test Circuit.

Project description:BackgroundHemocompatibility of left ventricular assist devices is essential for preventing adverse events. In this study, we compared the hemocompatibility of an axial-flow (Sputnik) to a centrifugal-flow (HeartMate 3) pump.MethodsBoth pumps were integrated into identical in vitro test circuits, each filled with 75 mL heparinized human blood of the same donor. During each experiment (n = 7), the pumps were operated with equal flow for six hours. Blood sampling and analysis were performed on a regular schedule. The analytes were indicators of hemolysis, coagulation activation, platelet count and activation, as well as extracellular vesicles.ResultsSputnik induced higher hemolysis compared to the HeartMate 3 after 360 min. Furthermore, platelet activation was higher for Sputnik after 120 min onward. In the HeartMate 3 circuit, the platelet count was reduced within the first hour. Furthermore, Sputnik triggered a more pronounced increase in extracellular vesicles, a potential trigger for adverse events in left ventricular assist device application. Activation of coagulation showed a time-dependent increase, with no differences between both groups.ConclusionsThis experimental study confirms the hypothesis that axial-flow pumps may induce stronger hemolysis compared to centrifugal pumps, coming along with larger amounts of circulating extracellular vesicles and a stronger PLT activation.

| S-EPMC9225365 | biostudies-literature

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