LVAD Cost for End-Stage HF Patients Ineligible for Transplant
LVAD Cost for End-Stage HF Patients Ineligible for Transplant
Background: A health technology assessment (HTA) of left ventricular assist devices (LVADs) as destination therapy in patients with end-stage heart failure was commissioned by the Dutch Health Care Insurance Board [College voor Zorgverzekeringen (CVZ)]. In this context, a systematic review of the economic literature was performed to assess the procedure's value for money.
Methods: A systematic search (updated in December 2013) for economic evaluations was performed by consulting various databases: the HTA database produced by the Centre for Reviews and Dissemination (CRD HTA), websites of HTA institutes, CRD's National Health Service Economic Evaluation Database (NHS EED), Medline (OVID) and EMBASE. No time or language restrictions were imposed and pre-defined selection criteria were used. The two-step selection procedure was performed by two people. References of the selected studies were checked for additional relevant citations.
Results: Six relevant studies were selected. Four economic evaluations relied on the results of the REMATCH trial to compare a pulsatile-flow LVAD with optimal medical therapy (OMT). These evaluations were performed before the publication of the HeartMate II (HM-II) Destination Therapy Trial which compared a pulsatile-flow with a continuous-flow LVAD. Two more recent economic evaluations combined the results of both trials to make an indirect comparison of a continuous-flow LVAD with OMT.
In all studies, the largest part of the incremental cost was due to the reimplantation cost of an LVAD, with a device cost of €58,000-€75,000 and about €55,000 for the surgical procedure. The survival gain was highest with a continuous-flow LVAD, up to about three life-years gained (LYG) versus OMT in the most optimistic study. Quality of life (QoL) was improved but measures with a generic utility instrument were lacking, making estimates on quality-adjusted life-years (QALYs) gained more uncertain. Incremental cost-effectiveness ratios of the two most recent studies were on average €107,600 and $198,184 (ca.€145,800) per QALY gained.
Conclusions: Although LVAD destination therapy improves survival and QoL, it remains questionable as to whether it offers value for money. This conclusion may alter if the price of the device/procedure decreases sufficiently, in combination with further improved outcomes for mortality, adverse events and QoL.
Mechanical circulatory support through left ventricular assist devices (LVADs) is increasingly being used as a bridge-to-transplantation (BTT) in patients with end-stage heart failure. As the number of patients with end-stage heart failure is growing without an accompanying increase in available donor hearts, LVADs are also being used as destination therapy as an alternative to heart transplantation.
A systematic review revealed two randomized trials which investigated LVADs as destination therapy, in patients with end-stage heart failure who were not candidates for cardiac transplantation. In 2001, the REMATCH trial, comparing a pulsatile-flow LVAD with optimal medical therapy (OMT), demonstrated improved one-year survival after LVAD support and was the basis for the Food and Drug Administration (FDA) to approve destination therapy in the United States. The relative mortality risk was 0.52 [95% confidence interval (CI), 0.34–0.78; P=0.001]. Survival at one year was 52% versus 28%, in favor of the pulsatile-flow LVAD over OMT. At two years, this was 29% versus 13%.
The second trial, published in 2009, compared a pulsatile-flow LVAD with a continuous-flow LVAD [HeartMate II (HM-II) Destination Therapy Trial]. The relative mortality risk was 0.54 (95% CI, 0.34–0.86; P=0.008). Survival at one year was 68% versus 55%. Survival at two years was 58% versus 24% in favor of the continuous-flow HM-II over the pulsatile-flow LVAD. Survival after implantation of a continuous-flow LVAD was thus significantly better than with an older pulsatile-flow device.
Partly based on economic considerations, the Dutch Health Care Insurance Board [College voor Zorgverzekeringen (CVZ)] concluded in 2007 that pulsatile-flow LVADs as destination therapy for end-stage heart failure could not be included in the basic healthcare package. Because of technological advances with smaller and better performing continuous-flow LVADs, a new health technology assessment (HTA) report was requested, including a systematic review of published economic evaluations and a primary economic evaluation of these LVADs as destination therapy in patients with end-stage heart failure. For this special issue of Annals of Cardiothoracic Surgery, an update of this systematic review of economic evaluations was performed.
Abstract and Introduction
Abstract
Background: A health technology assessment (HTA) of left ventricular assist devices (LVADs) as destination therapy in patients with end-stage heart failure was commissioned by the Dutch Health Care Insurance Board [College voor Zorgverzekeringen (CVZ)]. In this context, a systematic review of the economic literature was performed to assess the procedure's value for money.
Methods: A systematic search (updated in December 2013) for economic evaluations was performed by consulting various databases: the HTA database produced by the Centre for Reviews and Dissemination (CRD HTA), websites of HTA institutes, CRD's National Health Service Economic Evaluation Database (NHS EED), Medline (OVID) and EMBASE. No time or language restrictions were imposed and pre-defined selection criteria were used. The two-step selection procedure was performed by two people. References of the selected studies were checked for additional relevant citations.
Results: Six relevant studies were selected. Four economic evaluations relied on the results of the REMATCH trial to compare a pulsatile-flow LVAD with optimal medical therapy (OMT). These evaluations were performed before the publication of the HeartMate II (HM-II) Destination Therapy Trial which compared a pulsatile-flow with a continuous-flow LVAD. Two more recent economic evaluations combined the results of both trials to make an indirect comparison of a continuous-flow LVAD with OMT.
In all studies, the largest part of the incremental cost was due to the reimplantation cost of an LVAD, with a device cost of €58,000-€75,000 and about €55,000 for the surgical procedure. The survival gain was highest with a continuous-flow LVAD, up to about three life-years gained (LYG) versus OMT in the most optimistic study. Quality of life (QoL) was improved but measures with a generic utility instrument were lacking, making estimates on quality-adjusted life-years (QALYs) gained more uncertain. Incremental cost-effectiveness ratios of the two most recent studies were on average €107,600 and $198,184 (ca.€145,800) per QALY gained.
Conclusions: Although LVAD destination therapy improves survival and QoL, it remains questionable as to whether it offers value for money. This conclusion may alter if the price of the device/procedure decreases sufficiently, in combination with further improved outcomes for mortality, adverse events and QoL.
Introduction
Mechanical circulatory support through left ventricular assist devices (LVADs) is increasingly being used as a bridge-to-transplantation (BTT) in patients with end-stage heart failure. As the number of patients with end-stage heart failure is growing without an accompanying increase in available donor hearts, LVADs are also being used as destination therapy as an alternative to heart transplantation.
A systematic review revealed two randomized trials which investigated LVADs as destination therapy, in patients with end-stage heart failure who were not candidates for cardiac transplantation. In 2001, the REMATCH trial, comparing a pulsatile-flow LVAD with optimal medical therapy (OMT), demonstrated improved one-year survival after LVAD support and was the basis for the Food and Drug Administration (FDA) to approve destination therapy in the United States. The relative mortality risk was 0.52 [95% confidence interval (CI), 0.34–0.78; P=0.001]. Survival at one year was 52% versus 28%, in favor of the pulsatile-flow LVAD over OMT. At two years, this was 29% versus 13%.
The second trial, published in 2009, compared a pulsatile-flow LVAD with a continuous-flow LVAD [HeartMate II (HM-II) Destination Therapy Trial]. The relative mortality risk was 0.54 (95% CI, 0.34–0.86; P=0.008). Survival at one year was 68% versus 55%. Survival at two years was 58% versus 24% in favor of the continuous-flow HM-II over the pulsatile-flow LVAD. Survival after implantation of a continuous-flow LVAD was thus significantly better than with an older pulsatile-flow device.
Partly based on economic considerations, the Dutch Health Care Insurance Board [College voor Zorgverzekeringen (CVZ)] concluded in 2007 that pulsatile-flow LVADs as destination therapy for end-stage heart failure could not be included in the basic healthcare package. Because of technological advances with smaller and better performing continuous-flow LVADs, a new health technology assessment (HTA) report was requested, including a systematic review of published economic evaluations and a primary economic evaluation of these LVADs as destination therapy in patients with end-stage heart failure. For this special issue of Annals of Cardiothoracic Surgery, an update of this systematic review of economic evaluations was performed.
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