Abbott has launched the TEAM-HF ( терапии с помощью HeartMate 3) trial, a prospective, randomized study designed to evaluate the clinical benefits of earlier intervention with the HeartMate 3 left ventricular assist device (LVAD) in patients with worsening heart failure. This initiative challenges the current standard of care, which typically reserves LVAD implantation for patients with advanced heart failure who are heavily reliant on medication and have a poor prognosis.
The TEAM-HF trial plans to enroll up to 850 participants across the United States. Patients will be randomized to either receive a HeartMate 3 LVAD implant or continue with guideline-directed medical therapy. Pulmonary artery pressures (PAP) will be remotely monitored in both groups using Abbott’s CardioMEMS HF system, which is implanted via a catheter-based procedure. The trial will assess and compare the improvements in PAP between the two groups over a two-year period, with an option for long-term follow-up extending up to five years.
Objective Assessment for Timely Intervention
The trial's investigator highlighted that "the study aims to take the guesswork out of deciding when a patient has reached the ideal time for LVAD implementation." By employing objective measures to accurately assess heart failure progression, clinicians may be able to identify suitable candidates for LVAD therapy earlier in the course of their disease.
Potential Impact on Patient Outcomes
Keith Boettiger, vice president of Abbott’s heart failure business, stated, "Our hope is that the TEAM-HF study will revolutionize care management for these patients and their families. Getting people on a heart pump more quickly could mean more time spent out of the hospital and with loved ones." The anticipated results of the TEAM-HF study could lead to improved survival rates and enhanced quality of life for patients with advanced heart failure.
Market Context and Future Projections
GlobalData predicts the cardiovascular medical device market will reach $86.5 billion by 2030, while the LVAD market is projected to reach $2.24 billion by 2033. Abbott’s HeartMate 3 is currently a market leader in this field. In August, the FDA expanded the label for the HeartMate 3 device to eliminate the need for aspirin use as part of routine patient management, potentially improving its adoption compared to other LVAD devices.
