Cost-effectiveness of left ventricular assist devices (LVADs) for patients with advanced heart failure : analysis of the British NHS Bridge to Transplant (BTT) program

Background: A previous cost-effectiveness analysis showed that bridge to transplant (BTT) with early design left ventricular assist devices (LVADs) for advanced heart failure was more expensive than medical management while appearing less beneficial. Older LVADs were pulsatile, but current second and third generation LVADs are continuous flow pumps. This study aimed to estimate comparative cost-effectiveness of BTT with durable implantable continuous flow LVADs compared to medical management in the British NHS. Methods and results: A semi-Markov multi-state economic model was built using NHS costs data and patient data in the British NHS Blood and Transplant Database (BTDB). Quality-adjusted life years (QALYs) and incremental costs per QALY were calculated for patients receiving LVADs compared to those receiving inotrope supported medical management. LVADs cost £80,569 ($127,887) at 2011 prices and delivered greater benefit than medical management. The estimated probabilistic incremental cost-effectiveness ratio (ICER) was £53,527 ($84,963)/QALY (95%CI: £31,802–£94,853; $50,479–$150,560) (over a lifetime horizon). Estimates were sensitive to choice of comparator population, relative likelihood of receiving a heart transplant, time to transplant, and LVAD costs. Reducing the device cost by 15% decreased the ICER to £50,106 ($79,533)/QALY. Conclusions: Durable implantable continuous flow LVADs deliver greater benefits at higher costs than medical management in Britain. At the current UK threshold of £20,000 to £30,000/QALY LVADs are not cost effective but the ICER now begins to approach that of an intervention for end of life care recently recommended by the British NHS. Cost-effectiveness estimates are hampered by the lack of randomized trials

Cost-effectiveness of left ventricular assist devices (LVADs) for patients with advanced heart failure : analysis of the British NHS Bridge to Transplant (BTT) program

Background: A previous cost-effectiveness analysis showed that bridge to transplant (BTT) with early design left ventricular assist devices (LVADs) for advanced heart failure was more expensive than medical management while appearing less beneficial. Older LVADs were pulsatile, but current second and third generation LVADs are continuous flow pumps. This study aimed to estimate comparative cost-effectiveness of BTT with durable implantable continuous flow LVADs compared to medical management in the British NHS. Methods and results: A semi-Markov multi-state economic model was built using NHS costs data and patient data in the British NHS Blood and Transplant Database (BTDB). Quality-adjusted life years (QALYs) and incremental costs per QALY were calculated for patients receiving LVADs compared to those receiving inotrope supported medical management. LVADs cost £80,569 ($127,887) at 2011 prices and delivered greater benefit than medical management. The estimated probabilistic incremental cost-effectiveness ratio (ICER) was £53,527 ($84,963)/QALY (95%CI: £31,802–£94,853; $50,479–$150,560) (over a lifetime horizon). Estimates were sensitive to choice of comparator population, relative likelihood of receiving a heart transplant, time to transplant, and LVAD costs. Reducing the device cost by 15% decreased the ICER to £50,106 ($79,533)/QALY. Conclusions: Durable implantable continuous flow LVADs deliver greater benefits at higher costs than medical management in Britain. At the current UK threshold of £20,000 to £30,000/QALY LVADs are not cost effective but the ICER now begins to approach that of an intervention for end of life care recently recommended by the British NHS. Cost-effectiveness estimates are hampered by the lack of randomized trials

Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients The ROADMAP Study 2-Year Results

OBJECTIVES The authors sought to provide the pre-specified primary endpoint of the ROADMAP (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) trial at 2 years. BACKGROUND The ROADMAP trial was a prospective nonrandomized observational study of 200 patients (97 with a left ventricular assist device [LVAD], 103 on optimal medical management [OMM]) that showed that survival with improved functional status at 1 year was better with LVADs compared with OMM in a patient population of ambulatory New York Heart Association functional class IIIb/IV patients. METHODS The primary composite endpoint was survival on original therapy with improvement in 6-min walk distance \u3e= 75 m. RESULTS Patients receiving LVAD versus OMM had lower baseline health-related quality of life, reduced Seattle Heart Failure Model 1-year survival (78% vs. 84%; p = 0.012), and were predominantly INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profile 4 (65% vs. 34%; p \u3c 0.001) versus profiles 5 to 7. More LVAD patients met the primary endpoint at 2 years: 30% LVAD versus 12% OMM (odds ratio: 3.2 [95% confidence interval: 1.3 to 7.7]; p = 0.012). Survival as treated on original therapy at 2 years was greater for LVAD versus OMM (70 +/- 5% vs. 41 +/- 5%; p \u3c 0.001), but there was no difference in intent-to-treat survival (70 +/- 5% vs. 63 +/- 5%; p = 0.307). In the OMM arm, 23 of 103 (22%) received delayed LVADs (18 within 12 months; 5 from 12 to 24 months). LVAD adverse events declined after year 1 for bleeding (primarily gastrointestinal) and arrhythmias. CONCLUSIONS Survival on original therapy with improvement in 6-min walk distance was superior with LVAD compared with OMM at 2 years. Reduction in key adverse events beyond 1 year was observed in the LVAD group. The ROADMAP trial provides risk-benefit information to guide patient- and physician-shared decision making for elective LVAD therapy as a treatment for heart failure. (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients [ROADMAP]; NCT01452802

Practice Issues for Evaluation and Management of the Suicidal Left Ventricular Assist Device Patient

There is a high prevalence of depression among left ventricular assist device patients, who present with an increased risk of suicidality given access to means via the device either with nonadherence or disconnection. Suicidality via device nonadherence/disconnection is an underresearched clinical issue, as paradoxically this life-saving procedure can also provide a method of lethal means to patients with significant mental health concerns. A case study is used to highlight the course of an attempted suicide by ventricular assistive device nonadherence. Clinical implications and recommendations for practice include a thorough psychological evaluation presurgery, monitoring quality of life and coping styles before and after placement, psychological testing, outlining specific suicide protocols, psychiatric care considerations for patients with highly specialized medical devices, and related ethical concerns

Heart Failure Anticoagulation Teach-Back Education and Readmissions

abstract: Heart failure affects millions of Americans each year. Treatment of advanced heart failure with reduced ejection fraction and left ventricular failure is sometimes treated with implantation of a left-ventricular assist device. While living with this life-sustaining machine, anticoagulation with Coumadin is necessary. Many of these patients are readmitted within 30-days of being discharged for pump clots, gastro-intestinal bleeds and even strokes. Patients are often discharged without adequate education on Coumadin management, which promotes inadequate self-care and medication non-adherence. In current practice, healthcare providers lecture information in a quick manner without the evaluation of patients’ comprehension. Research suggests implementing the teach-back method during education sessions to assess for comprehension of material to improve medication adherence. Healthcare providers should implement Coumadin teach-back education to heart failure patients with left-ventricular assist devices to improve quality of life, increase medication adherence and decrease 30-day hospital readmission rates

The impact of peripheral arterial disease on patients with mechanical circulatory support.

Background: Left ventricular assist devices (LVAD) are indicated as bridging or destination therapy for patients with advanced (Stage D) heart failure and reduced ejection fraction (HFrEF). Due to the clustering of the mutual risk factors, HFrEF patients have a high prevalence of peripheral arterial disease (PAD). This, along with the fact that continuous flow LVAD influence shear stress on the vasculature, can further deteriorate the PAD. Methods: We queried the National Inpatient Sample (NIS) database (2002-2014) to identify the burden of pre-existing PAD cases, its association with LVAD, in-hospital mortality, and other complications of LVAD. The adjusted odds ratio (aOR) and 95% confidence interval (CI) were calculated using the Cochran-Mantel-Haenszel test. Results: A total of 20,817 LVAD patients, comprising of 1,625 (7.8%) PAD and 19,192 (91.2%) non-PAD patients were included in the study. The odds of in-hospital mortality in PAD patients were significantly higher compared to non-PAD group (OR 1.29, CI, 1.07-1.55, P = 0.007). The PAD group had significantly higher adjusted odds as compared to non-PAD group for acute myocardial infarction (aOR 1.29; 95% CI, 1.07-1.55, P = 0.007), major bleeding requiring transfusion (aOR, 1.286; 95% CI, 1.136-1.456, P \u3c 0.001), vascular complications (aOR, 2.360; 95% CI, 1.781-3.126, P \u3c 0.001), surgical wound infections (aOR, 1.50; 95% CI, 1.17-1.94, P = 0.002), thromboembolic complications (aOR, 1.69; 95% CI, 1.36-2.10, P \u3c 0.001), implant-related complications (aOR, 1.47; 95% CI, 1.19-1.80, P \u3c 0.001), and acute renal failure (aOR, 1.26; 95% CI, 1.12-1.43, P \u3c 0.001). Conclusion: PAD patients can have high LVAD associated mortality as compared to non-PAD

Modeling payback from research into the efficacy of left-ventricular assist devices as destination therapy

Objectives: Ongoing developments in design have improved the outlook for left-ventricular assist device (LVAD) implantation as a therapy in end-stage heart failure. Nevertheless, early cost-effectiveness assessments, based on first-generation devices, have not been encouraging. Against this background, we set out (i) to examine the survival benefit that LVADs would need to generate before they could be deemed cost-effective; (ii) to provide insight into the likelihood that this benefit will be achieved; and (iii) from the perspective of a healthcare provider, to assess the value of discovering the actual size of this benefit by means of a Bayesian value of information analysis. Methods: Cost-effectiveness assessments are made from the perspective of the healthcare provider, using current UK norms for the value of a quality-adjusted life-year (QALY). The treatment model is grounded in published analyses of the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial of first-generation LVADs, translated into a UK cost setting. The prospects for patient survival with second-generation devices is assessed using Bayesian prior distributions, elicited from a group of leading clinicians in the field. Results: Using established thresholds, cost-effectiveness probabilities under these priors are found to be low (.2 percent) for devices costing as much as £60,000. Sensitivity of the conclusions to both device cost and QALY valuation is examined. Conclusions: In the event that the price of the device in use would reduce to £40,000, the value of the survival information can readily justify investment in further trials

Implications of Transitional Care Interventions on Hospital Readmissions in Patients With Destination Therapy Left Ventricular Assist Devices

Background: The rising number of patients with a left ventricular assist device (LVAD) require care management to successfully transition home after implantation. These patients and their families need to manage their heart failure, and the complexities of an LVAD and the associated lifestyle modifications. Translating knowledge of transitional care interventions in patients with chronic diseases to those with an LVAD may provide valuable insight. To help inform the furthering of care transitions in the LVAD patient population, an integrative review was conducted. Aim: The aim of this review was to explore the transitions of care interventions of care in patients and its potential for application in the destination therapy LVAD. Methods: This integrative review was guided by the Whittemore and Knafl's methodology. Results: A total of 12 articles from 264 retrieved articles met inclusion criteria and were included in the literature review. Discussion: This review identified that evidence-based transitional care interventions have been shown to decrease avoidable rehospitalization, the associated costs, and improve quality of life when compared to usual care. Implications for Practice: A common feature of transitional care interventions is the inclusion of nurse leadership. Nurses should be prepared to participate in transitional care interventions to optimally improve outcomes for patients with heart failure and potentially those with an LVAD. Additionally, to make transitional care interventions more effective they should be implemented with moderate intensity or greater. Conclusion: This review provided information supporting the trialing of transitional care interventions in patients with an LVAD and suggests pilot research to optimize interventions for this population

Short- and long-term effects of a cardiac rehabilitation program in patients implanted with a left ventricular assist device

The efficacy of cardiac rehabilitation in heart-failure patients who received a left-ventricular assist device (LVAD) instead of heart transplantation (HTx) is still unclear. This study aims to evaluate whether cardiac rehabilitation is beneficial in LVAD as HTx patients in the short term and whether its effects in LVAD patients persist over time. Twenty-five LVAD patients were evaluated by functional and psychological tests at admission (T0) and discharge (T1) of a 4-week inpatient structured rehabilitation program, and follow-ups 3 (T2), 6 (T3), and 12 months (T4) after discharge. Twenty-five matched HTx patients were also studied from T0 to T1 to compare the improvements in the six-minute walk test (6MWT). The quality-of-life scores substantially improved in LVAD patients and the 6MWT showed the same functional recovery as in HTx patients from T0 to T1. After T1, numerous LVAD patients withdrew from the study. However, the 6MWT outcome increased further from T1 to T3, with a positive trend during the follow-ups. Hemoglobin and the ventilatory performance increased, and the psychological perception of heart-failure symptoms and pain further improved at T2. In conclusion, exercise-based rehabilitation programs provide similar beneficial effects in LVAD and HTx patients, without deterioration in LVAD patients up to 12 months after discharge

Heart Rate Variability: A possible machine learning biomarker for mechanical circulatory device complications and heart recovery

Cardiovascular disease continues to be the number one cause of death in the United States, with heart failure patients expected to increase to \u3e8 million by 2030. Mechanical circulatory support (MCS) devices are now better able to manage acute and chronic heart failure refractory to medical therapy, both as bridge to transplant or as bridge to destination. Despite significant advances in MCS device design and surgical implantation technique, it remains difficult to predict response to device therapy. Heart rate variability (HRV), measuring the variation in time interval between adjacent heartbeats, is an objective device diagnostic regularly recorded by various MCS devices that has been shown to have significant prognostic value for both sudden cardiac death as well as all-cause mortality in congestive heart failure (CHF) patients. Limited studies have examined HRV indices as promising risk factors and predictors of complication and recovery from left ventricular assist device therapy in end-stage CHF patients. If paired with new advances in machine learning utilization in medicine, HRV represents a potential dynamic biomarker for monitoring and predicting patient status as more patients enter the mechanotrope era of MCS devices for destination therapy