A new study published on Circulation (Circulation.2019;139:337–346. DOI: 10.1161/CIRCULATIONAHA.118.038269), the outcomes of which have been presented at the AHA congress by prof. Navin K. Kapur (Tufts Medical Center), confirms efficiency and safety of Abiomed Impella CP on unloading the left ventricle in patients presenting with anterior ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock.
All patients received acute mechanical unloading with the Impella CP system and were then randomly assigned to arms:
- LV unloading followed by immediate reperfusion (U-IR);
- LV unloading with a 30-minute delay to reperfusion (U-DR).
This comparison was specifically designed to test whether unloading the myocardium for 30 minutes before reperfusion was feasible and safe.
The primary safety outcome was a composite of major adverse cardiovascular and cerebrovascular events (MACCE) including:
- cardiovascular mortality;
- or major vascular events at 30 days.
Additional safety parameters included all-cause mortality, hemolysis, acute renal dysfunction, hospitalization for heart failure, ventricular arrhythmias, LV thrombus, bleeding, and minor vascular events.
The multi-center study, which involved 50 patients, found:
- Unloading associated with delaying reperfusion by 30 minutes did not increase 30-day adverse cardiovascular and cerebrovascular events (MACCE);
- Furthermore, there is a tendency to reduce the size of the infarct which will have to be confirmed by future trials.
If it will be confirmed in future trials, it must be expected an improvement of the existing guidelines for STEMI patients.
The study will further examine whether unloading with Impella CP for 30 minutes prior to reperfusion will potentially slow down or avoid the development of heart failure.
Abiomed also announces that, in agreement with the FDA, it will move forward with a pivotal, multi-center, prospective, randomized controlled trial comparing unloading with delayed reperfusion to the current standard of care.
The Impella suite has several systems for temporary ventricular support. These systems can be applied in both interventional procedures, such as percutaneous coronary interventional procedures (PCI) and as support in cardiosurgical bypass procedures in high-risk patients. Or as a support to the circulation in patients with depressed ventricular function in the presence or absence of cardiogenic shock.