Economic Outcomes Data Presented for Medtronic's HeartWare HVAD System
April 8, 2019—Medtronic announced the presentation of economic outcomes data for its HeartWare HVAD system, a left ventricular assist device (LVAD), after analyzing multiple clinical studies. The economic analyses of the HVAD system were presented at the 2019 International Society for Heart and Lung Transplantation Annual Meeting and Scientific Sessions held April 3–6 in Orlando, Florida.
The first analysis evaluated heart failure patients who received the HVAD system through a less invasive thoracotomy procedure in the LATERAL study. According to the company, the findings demonstrated that these patients incurred lower hospitalization and medical supply costs than patients who received a ventricular assist device (VAD) through the traditional sternotomy implantation procedure.
The average total cost per patient in the LATERAL thoracotomy study was $204,107, compared to $260,492 for nonstudy patients who were treated with traditional median sternotomy VAD (P < .001).
Medtronic reported that a second analysis demonstrated substantially improved cost-effectiveness of the HVAD system when used as a bridge to heart transplant (BTT) or as a longer-term destination therapy (DT) in patients with advanced heart failure who are not candidates for heart transplants, as compared to previously published United States cost-effectiveness analyses.
In the BTT population, the HVAD system showed approximately a two-thirds reduction in the incremental cost-effectiveness ratio (ICER), from $226,300 in a 2014 analysis to $69,561 in the current analysis (per quality-adjusted life-year gained over a patient's lifetime).
In the DT population, the current analysis demonstrated an ICER of $102,499 for the HVAD system—a dramatic reduction from four previous United States–based economic analyses (conducted 2004–2016) of predominantly competitive LVADs that estimated the ICER from $209,400 to $802,700.
The analysis was conducted using HVAD patient data from the ADVANCE-BTT + CAP, ENDURANCE, and ENDURANCE Supplemental clinical trials as well as Medicare cost data and Seattle Heart Failure Model estimates, noted Medtronic.
Scott Silvestry, MD, who is Surgical Director of Thoracic Transplant at AdventHealth Transplant Institute in Orlando, Florida, commented on these findings in the company's announcement. Dr. Silvestry stated, “These studies help us understand the cost-effectiveness and economic value of the HVAD system, demonstrating a greater level of cost-effectiveness than previously reported for LVAD therapy. The progress toward greater cost-effectiveness is an important advance that will support wider adoption of LVAD therapy for indicated patients.”
Additionally, Medtronic announced that the LATERAL trial results were published by Edwin McGee Jr, MD, et al in The Journal of Heart and Lung Transplantation. The study demonstrated 87% survival at 2 years and a 30% reduction in the length of hospital stay for patients who received the HVAD system via thoracotomy, compared to patients who received their HVAD system via a sternotomy.
The company advised that the HVAD system was approved in Japan in 2018 for BTT in patients with advanced heart failure. In February 2019, Health Canada licensed the HVAD system for implantation via the thoracotomy approach. The HVAD system is now approved for BTT and DT patients, via both sternotomy and thoracotomy implant techniques, in the United States, Canada, and in countries recognizing CE Mark approval.