Hybrid Device for Heart Failure Shows Early Promise
A new dual-function implant may offer both symptom relief and protection from sudden cardiac death
Early results from the Integra-D trial suggest that a new cardiac contractility modulation-defibrillator (CCM-D) can safely combine two therapies in one device for patients with heart failure with reduced ejection fraction (HFrEF). The device achieved 100% success in defibrillation testing and improved or stabilized symptoms in most patients at six months.
Study Details
The Integra CCM-D was tested in the ongoing Integra-D trial, which enrolled 300 patients with heart failure and an ejection fraction of 40% or less. These individuals were eligible for an implantable defibrillator but not for cardiac resynchronization therapy. The early report presented at the Heart Failure Society of America meeting covered the first 100 patients who underwent successful defibrillation testing.
Methodology
The device integrates two functions:
Defibrillator therapy to prevent sudden cardiac death.
Cardiac contractility modulation (CCM) therapy, which delivers non-excitatory signals to the heart during its refractory period to improve contractile strength.
Patients received the device via standard implantation. The rechargeable battery powers daily CCM therapy, while a non-rechargeable battery manages defibrillation and pacing. Patients are required to recharge the device for 60 minutes once a week.
Key Findings
Defibrillation success: 100% among the first 100 patients tested.
CCM therapy delivered: 89% within 30 days, with no inappropriate CCM events.
Symptom stability or improvement: 88% of patients had improved or stable NYHA functional class at six months.
Safety: No unexpected device-related complications at one month. Isolated cases of lead dislodgement, infection, or pericarditis were reported.
Compliance: 91% of patients followed the charging protocol at 30 days.
Implications for Practice
If approved, the Integra CCM-D could fill a treatment gap for HFrEF patients who remain symptomatic despite medication and are not eligible for resynchronization therapy. By combining sudden cardiac death protection with CCM therapy, it may reduce hospitalizations, improve quality of life, and streamline device management. FDA review will follow once full 6-month data for all 300 patients are available.