US-based medical devices firm Abiomed has reported positive results from the clinical trial of Impella CP heart pump in patients with anterior ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock.
Data showed that unloading the left ventricle with the device for 30 minutes prior to reperfusion is safe and feasible, compared to Impella patients who were reperfused immediately.
The Impella CP pump can be inserted during a standard catheterisation procedure via the femoral artery, into the ascending aorta, across the valve and into the left ventricle.
It extracts blood from the left ventricle through an inlet area present near the tip. The blood is then expelled from the catheter into the ascending aorta.
The randomised, multi-centre FDASTEMI Door-to-Unloading safety and feasibility trial further demonstrated that initial unloading and delay of reperfusion by 30 minutes did not enhance 30-day major adverse cardiovascular and cerebrovascular events (MACCE) or infarct size.
This approach of unloading was found to minimise infarct size. In addition, the results indicated complete adherence to the 30-minute unloading protocol and 100% success of Impella CP insertion in both the study arms.
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Study co-principal investigator Navin Kapur said: “If a reduction of infarct size from unloading before reperfusion is confirmed in a future trial, this concept would enhance the existing guidelines of immediate reperfusion for STEMI patients.
“75% of patients experiencing their first heart attack will develop heart failure within five years, so new approaches are needed to reduce infarct size and prevent heart failure. Pre-clinical non-human datasets show unloading the left ventricle prior to reperfusion activates a cardioprotective program that reduces reperfusion injury, and could improve the current standard of care.”
Abiomed is planning to conduct a separate pivotal, multi-centre, prospective, randomised controlled trial next year to compare unloading with delayed reperfusion to the current standard of care.