Abbott has launched the TEAM-HF trial, a prospective study designed to identify advanced heart failure patients who may benefit from earlier intervention with the HeartMate 3 left ventricular assist device (LVAD). The trial aims to address the current practice of delaying LVAD implantation until patients are heavily reliant on medication and have a poor prognosis, hypothesizing that earlier LVAD administration could improve outcomes.
Trial Design and Objectives
The TEAM-HF trial plans to enroll up to 850 patients across the United States who are experiencing worsening heart failure. Participants will be randomized to either receive a HeartMate 3 LVAD implant or continue their existing heart failure medication regimen. Pulmonary artery pressures (PAP) will be remotely monitored using Abbott’s CardioMEMS HF system, which is implanted via a catheter-based procedure. The primary objective is to 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.
Clinical Significance and Expert Commentary
The trial investigator emphasized that "the study aims to take the guesswork out of deciding when a patient has reached the ideal time for LVAD implementation." 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."
Context of LVAD Therapy
LVADs are mechanical pumps that support heart function in patients with advanced heart failure. GlobalData predicts the cardiovascular medical device market will reach $86.5 billion by 2030, with the LVAD market specifically reaching $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.
Anticipated Impact
By establishing more objective methods to assess heart failure progression, healthcare professionals may be able to provide patients with improved survival rates and quality of life through earlier access to LVAD therapy. The TEAM-HF study is poised to provide critical insights into the optimal timing of LVAD implantation in advanced heart failure patients.
