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

Scott C Silvestry, Claudius Mahr, Mark S Slaughter, Wayne C Levy, Richard K Cheng, Damian M May, Eleni Ismyrloglou, Stelios I Tsintzos, Edward Tuttle, Keziah Cook, Erica Birk, Aparna Gomes, Sophia Graham, William G Cotts, Scott C Silvestry, Claudius Mahr, Mark S Slaughter, Wayne C Levy, Richard K Cheng, Damian M May, Eleni Ismyrloglou, Stelios I Tsintzos, Edward Tuttle, Keziah Cook, Erica Birk, Aparna Gomes, Sophia Graham, William G Cotts

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.

Trial registration: ClinicalTrials.gov NCT00751972 NCT01166347 NCT01966458.

Figures

Figure 1.
Figure 1.
“Simplified” model representation. LVAD, left ventricular assist device; MM, medical management; AE, adverse event; mRS, modified Rankin Scale; GI, gastrointestinal; HF, heart failure.
Figure 2.
Figure 2.
Survival curves—BTT and DT. UNOS, United Network for Organ Sharing; BTT, bridge to transplant; DT, destination therapy; SHFM, Seattle Heart Failure Model.
Figure 3.
Figure 3.
Tornado diagram—One-way sensitivity analyses on major adverse events. ICER, Incremental Cost-Effectiveness Ratio; GI, gastrointestinal; QALY, Quality-Adjusted Life Years.
Figure 4.
Figure 4.
Incremental cost-effectiveness ratio scatterplot and cost-effectiveness acceptability curve (CEAC): (A) bridge-to-transplant scatterplot, (B) destination–therapy scatterplot, (C) bridge-to-transplant CEAC, and (D) destination-therapy CEAC. QALY< Quality-Adjusted Life Years.
Figure 5.
Figure 5.
LVAD cost-effectiveness studies—U.S. Special Report 2004. Rogers et al. (2012); Long et al. (2014); Baras Shreibati et al. (2017). QALY, Quality-Adjusted Life Years.

References

    1. Dracup K, Walden JA, Stevenson LW, Brecht ML. Quality of life in patients with advanced heart failure. J Heart Lung Transplant 1992.11(2 Pt 1): 273–279.
    1. Heidenreich PA, Albert NM, Allen LA, et al. . Forecasting the impact of heart failure in the United States a policy statement from the American Heart Association. Circ Hear Fail 2013.6: 606–619.
    1. Benjamin EJ, Blaha MJ, Chiuve SE, et al. . Heart Disease and Stroke Statistics’2017 Update: A Report from the American Heart Association. Circulation 2017.135: e146–e603.
    1. Abouezzeddine OF, Redfield MM. Who has advanced heart failure? Definition and epidemiology. Congest Hear Fail 2011.17: 160–168.
    1. McMurray JJ, Adamopoulos S, Anker SD, et al. ; Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology; ESC Committee for Practice Guidelines: ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail 2012.14: 803–869.
    1. Lund LH, Khush KK, Cherikh WS, et al. . The registry of the International Society for Heart and Lung Transplantation: Thirty-fourth Adult Heart Transplantation Report—2017; Focus Theme: Allograft ischemic time. J Hear Lung Transplant 2017.36: 1037–1046.
    1. Colvin M, Smith JM, Hadley N, et al. . OPTN/SRTR 2017 annual data report: Heart. Am J Transplant 2019.19: 323–403.
    1. Stein LH, Choudhary M, Silvestry SC. Donor heart allocation. In: Heart Transplantation. 2018. InTech; Available at: .
    1. Long EF, Swain GW, Mangi AA. Comparative survival and cost-effectiveness of advanced therapies for end-stage heart failure. Circ Heart Fail 2014.7: 470–478.
    1. Rogers JG, Bostic RR, Tong KB, Adamson R, Russo M, Slaughter MS. Cost-effectiveness analysis of continuous-flow left ventricular assist devices as destination therapy. Circ Heart Fail 2012.5: 10–16.
    1. Special report: Cost-effectiveness of left-ventricular assist devices as destination therapy for end-stage heart failure. Technol Eval Cent Assess Program Exec Summ 2004.19: 1.
    1. Baras Shreibati J, Goldhaber-Fiebert JD, Banerjee D, Owens DK, Hlatky MA. Cost-effectiveness of left ventricular assist devices in ambulatory patients with advanced heart failure. JACC Heart Fail 2017.5: 110–119.
    1. Yancy CW, Jessup M, Bozkurt B, et al. . 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation 2017.136: e137–e161.
    1. Ponikowski P, Voors AA, Anker SD, et al. ; ESC Scientific Document Group: 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J 2016.37: 2129–2200.
    1. Caro JJ, Briggs AH, Siebert U, Kuntz KM. Modeling good research practices—Overview: A report of the ISPOR-SMDM modeling good research practices task force-1. Value Heal 2012.15: 796–803.
    1. Sanders GD, Neumann PJ, Basu A, et al. . Recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses: Second panel on cost-effectiveness in Health and Medicine. JAMA 2016.316: 1093–1103.
    1. Slaughter MS, Pagani FD, McGee EC, et al. . HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transplant 2013.32: 675–683.
    1. Aaronson KD, Silvestry SC, Maltais S, et al. . Patients awaiting heart transplantation on HVAD support for greater than 2 years. ASAIO J 2016.62: 384–389.
    1. Milano CA, Rogers JG, Tatooles AJ, et al. . HVAD: The ENDURANCE supplemental trial. JACC Hear Fail 2018.6: 792–802.
    1. Colvin M, Smith JM, Hadley N; et al: OPTN/SRTR 2016 annual data report: Heart. Am J Transplant 2018.18: 291–362.
    1. Samsa GP, Reutter RA, Parmigiani G, et al. . Performing cost-effectiveness analysis by integrating randomized trial data with a comprehensive decision model: application to treatment of acute ischemic stroke. J Clin Epidemiol 1999.52: 259–271.
    1. Kirklin JK, Pagani FD, Kormos RL, et al. . Eighth annual INTERMACS report: Special focus on framing the impact of adverse events. J Heart Lung Transplant 2017.36: 1080–1086.
    1. Shireman TI, Wang K, Saver JL, et al. ; SWIFT-PRIME Investigators: Cost-effectiveness of solitaire stent retriever thrombectomy for acute ischemic stroke: Results from the SWIFT-PRIME Trial (solitaire with the intention for thrombectomy as primary endovascular treatment for acute ischemic stroke). Stroke 2017.48: 379–387.
    1. York Health Economics Consortium. Probabilistic/Stochastic Sensitivity Analysis [online]. 2016. Available at: . Accessed August 27, 2019.
    1. Grady KL, Naftel D, Stevenson L, et al. . Overall quality of life improves to similar levels after mechanical circulatory support regardless of severity of heart failure before implantation. J Heart Lung Transplant 2014.33: 412–421.
    1. Sharples LD, Dyer M, Cafferty F, et al. . Cost-effectiveness of ventricular assist device use in the United Kingdom: Results from the evaluation of ventricular assist device programme in the UK (EVAD-UK). J Heart Lung Transplant 2006.25: 1336–1343.
    1. Rose EA, Gelijns AC, Moskowitz AJ, et al. ; Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group: Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med 2001.345: 1435–1443.
    1. Rogers JG, Pagani FD, Tatooles AJ, et al. . Intrapericardial left ventricular assist device for Advanced Heart Failure. N Engl J Med 2017.376: 451–460.
    1. Neumann PJ, Kim DD, Trikalinos TA, et al. . Future directions for cost-effectiveness analyses in Health and Medicine. Med Decis Making 2018.38: 767–777.
    1. Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness—the curious resilience of the $50,000-per-QALY threshold. N Engl J Med 2014.371: 796–797.
    1. Agostoni P, Paolillo S, Mapelli M, et al. . Multiparametric prognostic scores in chronic heart failure with reduced ejection fraction: A long-term comparison. Eur J Heart Fail 2018.20: 700–710.
    1. Levy WC, Dardas TF. Comparison of cardiopulmonary-based risk models with a clinical heart failure risk model. Eur J Heart Fail 2018.20: 711–714.
    1. Canepa M, Fonseca C, Chioncel O, et al. ; ESC HF Long Term Registry Investigators: Performance of prognostic risk scores in Chronic Heart Failure Patients Enrolled in the European Society of Cardiology Heart Failure Long-Term Registry. JACC Heart Fail 2018.6: 452–462.
    1. Shiraishi Y, Kohsaka S, Nagai T, et al. . Validation and recalibration of seattle heart failure model in Japanese Acute Heart Failure Patients. J Card Fail 2019.25: 561–567.
    1. Paolillo S, Veglia F, Salvioni E, et al. ; MECKI Score Research Group (see Appendix): Heart failure prognosis over time: how the prognostic role of oxygen consumption and ventilatory efficiency during exercise has changed in the last 20 years. Eur J Heart Fail 2019.21: 208–217.
    1. Trivedi JR, Slaughter MS. “Unintended” consequences of changes in Heart Transplant Allocation Policy: Impact on practice patterns. ASAIO J 2020.66: 125–127.
    1. Cogswell R, John R, Estep JD, et al. . An early investigation of outcomes with the new 2018 donor heart allocation system in the United States. J Hear Lung Transplant 2020.39: 1–4.
    1. Bureau of Labor Statistics. Available at: . Accessed November 29, 2018.
    1. Smedira NG, Hoercher KJ, Lima B, et al. . Unplanned hospital readmissions after heartmate II implantation. JACC Hear Fail 2013.1: 31–39.
    1. Aaronson KD, Slaughter MS, Miller LW, et al. ; HeartWare Ventricular Assist Device (HVAD) Bridge to Transplant ADVANCE Trial Investigators: Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation. Circulation 2012.125: 3191–3200.

Source: PubMed

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