Abbott has announced a new, “first-of-its-kind” clinical trial designed to improve outcomes in patients with worsening heart failure who could benefit from advanced therapy options. The TEAM-HF trial—which is planned to enrol up to 850 patients across 75 sites worldwide—will measure pulmonary artery pressures (PAP) using the company’s CardioMEMS HF system to objectively identify advanced heart failure patients at high risk of mortality who could benefit from a life-saving HeartMate 3 left ventricular assist device (LVAD) earlier in their disease progression.
“The goal of the TEAM-HF trial is simple in concept but critical to the future care of patients. We want to break down patient care silos, offering a unified effort to not only improve the diagnosis of advanced heart failure but also enable rapid access to life saving heart pumps. This study aims to take the guess work out of deciding when a patient has reached the ideal time for LVAD implementation,” said Jennifer Cowger (Henry Ford Health, Detroit, USA), one of the national co-principal investigators for the TEAM-HF trial. “Too many patients are not receiving timely access to this life-saving therapy and are needlessly dying of heart failure. The importance of patient access to multidisciplinary heart failure care is embodied in the trial acronym, TEAM-HF, and we feel this study will be instrumental in helping providers identify patients who may benefit from a heart pump earlier in their care journey.”
Patients with end-stage heart failure who rely on intravenously administered heart failure medications designed to strengthen the heart’s blood pumping ability have poor outcomes, with a median survival of nine months, as noted in a recent press release from Abbott. According to the company, guideline recommendations for treating patients who depend on these medications include advanced therapies like LVADs—however, patients who are not yet dependent on medication also have a poor clinical prognosis yet are often not referred for these advanced options until their symptoms worsen. This delay is partly due to the lack of objective measures to identify patients who would most benefit from an LVAD, the release adds.
The TEAM-HF trial will deploy a novel approach to assess the impact of earlier interventions in patients with worsening heart failure. Investigators will first examine PAP data securely collected from study participants using Abbott’s CardioMEMS HF system. The CardioMEMS sensor—placed in the pulmonary artery via a minimally invasive outpatient procedure—monitors pulmonary artery pressure changes over time. If pressures do not go down with guideline directed medical therapy, the TEAM-HF trial will seek to prove that such patients will benefit from advanced therapies. These patients will be randomised to receive either the HeartMate 3 LVAD implant or continued treatment with their existing heart failure medications. Patients whose existing medications reduce their PAP levels will enter a single-arm registry where they will continue to be managed based on data from their CardioMEMS sensor.
“As the only healthcare company in the world that has developed medical devices designed to treat people at each stage of heart failure, our hope is that the TEAM-HF study will revolutionise 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,” said Keith Boettiger, vice president of Abbott’s heart failure business. “By having more objective methods to accurately gauge heart failure progression and refer people to receive this life-saving therapy faster, healthcare experts will be able to provide patients with improved survival rates and quality of life based on the anticipated results of the TEAM-HF study.”
Abbott’s recent press release details that enrolment in TEAM-HF will commence “shortly” at sites across the USA, with the trial’s powered primary and secondary endpoints set to be evaluated at two years, and long-term follow-up scheduled through five years.
