Impella ECP^™ Pivotal Study: First Results

“Impella ECP is the first transvalvular axial flow pump with compressible pump architecture to complete a pivotal IDE trial with significant clinical experience,” states Amir Kaki, MD, FACC, FSCAI, the principal investigator for the Impella ECP Pivotal Study.

Dr. Kaki explains that the Impella ECP has a 21Fr pump that is compressible to 9Fr for insertion and removal through a 9Fr arterial introducer sheath. Impella ECP is delivered wirelessly across the aortic valve into the left ventricle (LV) with a specifically designed pigtail catheter that allows aortic valve crossing in patients without aortic stenosis. “It’s had a 100% success rate in crossing the aortic valve in over 500 cases,” Dr. Kaki emphasizes, with the average time required to cross the aortic valve being just over one minute.

Impella ECP has a soft atraumatic cannula that crosses the aortic valve, opens when the pump is flowing and allows aortic valve closure when the device is not pumping. Impella ECP is able to deliver up to 5.5 L/min peak flow in systole with an average flow of 2.7-3.8 L/min at P-9.

The Impella ECP Pivotal Study was a prospective, multicenter, single-arm trial conducted at 18 sites in 2022 and 2023 in hemodynamically stable patients undergoing elective or urgent high-risk percutaneous coronary intervention (HRPCI). The objective of the study was to demonstrate the safety and effectiveness of Impella ECP use in HRPCI.

The primary endpoint was 30-day major adverse cardiovascular and cerebrovascular events (MACCE). Secondary endpoints were length of stay, major hemolysis, aortic valve injury and transition to Impella CP®. Safety endpoints were Impella ECP-related major bleeding and Impella ECP-related major vascular complications.

The study enrolled 256 patients, with 238 of those patients evaluable for the primary endpoint at 30 days. “The composite MACCE was 6.3% with the upper bound of the confidence interval at 9.5%, which was way below the performance goal of 24.4%,” Dr. Kaki explains. With regard to safety endpoints, 5.9% of patients experienced Impella ECP-related major bleeding (≥BARC 3) and 1.6% experienced Impella ECP-related major vascular complications. No aortic valve injury or major hemolysis was observed, two patients transitioned to Impella CP, and the median length of hospital stay was one day.

Dr. Kaki explains that there was no protocol-specified vascular closure strategy; however, with the 9Fr introducer, 70% of patients received an 8Fr Angio-Seal as first closure method with 92% success rate.

After the completion of this pivotal trial, the FDA approved the continuous access program at active sites, and now more than 500 patients have been treated. “The ECP will be submitted to the FDA for HRPCI for up to 6 hours,” Dr. Kaki explains, “and preparation of submission to the FDA for pre-market approval is ongoing and expected shortly.”

CAUTION: The Impella ECP system is currently under clinical investigation and not approved for commercial use.