The latest results from trials examining Abiomed‘s Impella 2.5 Percutaneous Circulatory Support System, the world’s smallest left ventricle heart pump, are in, and they give the company, us and hoping clinicians a happy feeling. The big hurdle that the company has to overcome is to convince cardiologists that Impella devices are easy to place under difficult circumstances (such as developing high-risk PCI, MI in cath lab, failing ventricle), and are safe for patients. Also, Abiomed has to prove to cardiologists that Impella provides a clinical advantage versus intraaortic balloon pumps (IABP), when a patient’s heart is failing and needs an emergency ventricular support in the cath lab. On both of these points, it seems the company scored positive results in the latest trials.
From Abiomed’s press office:
USpella [is] the first U.S. multicenter registry of Impella 2.5 patients evaluating the safety and feasibility of left ventricular support with the Impella 2.5 during high-risk percutaneous coronary intervention (PCI) and treatment of acute myocardial infarction (AMI).
High-Risk PCI patient results in USpella
In 64% of the high-risk PCI cases, the patients had been turned down for CABG before treated with Impella 2.5 The high-risk PCI population presented with a more complex anatomy than the SYNTAX trial population (of 23), decreasing SYNTAX score from 38 to 18 after effective revascularization with Impella 2.5 Registry results reaffirmed ejection fraction increases that were similar to PROTECT I results, with improved ejection fraction in USpella high-risk PCI patients increasing from 29 to 34, after Impella 2.5 support Reported overall MACE was low at 6% 30-day survival rate was 97%
AMI patient results in USpella
Impella was used after conventional therapies failed, (88% after emergent revascularization; 88% after high-dose inotropes; 68% after IABP therapy Impella improved hemodynamics in AMI shock patients, improving cardiac index from 1.9 to 2.5 l/min/m2, increasing mean arterial pressure from 62 to 87 mmHg, and decreasing wedge pressure from 28 to 20 mmHg, as well as decreasing overall Systemic Vascular Resistance (SVR) After Impella 2.5 support, overall ejection fraction in AMI patients improved from 29 to 37%; Impella successfully supported AMI refractory shock patients with 69% survival to the next therapy or onto recovery. Also, 58% of AMI shock patients and 89% of AMI patients with no shock were discharged
The MACH II trial, evaluating safety and feasibility in STEMI, included 20 patients; ten patients were treated with three days of Impella 2.5 support; ten control patients were treated with routine standard of care. The initial four-month results, which demonstrated significant recovery of left ventricular function in Impella 2.5 patients, were published in the Journal of American College of Cardiology in 2008.
All patients were measured in an IRB-approved protocol that calculated echo results, exercise testing and quality of life, and showed the following results from core laboratory analysis and strict processes:
Left ventricular ejection fraction in Impella 2.5 patients increased from 28% at the baseline, to 41% in the four-month analysis, to 51% at the three-year follow-up period. Left ventricular ejection fraction in the control patients increased from 40% at the baseline, to 45% after the four-month analysis to 47% at the three year analysis. Impella 2.5 patients continued to show improvement in left ventricular ejection fraction, demonstrating a net increase of 23 ejection fraction points while control patients only showed a net increase of 7 ejection fraction points. Significant benefit in exercise capacity was demonstrated stronger by Impella 2.5 patients, than control patients, which also improves the quality of life for the patient Impella 2.5 patients saw no effects on aortic valve at three-year follow-up
Press releases: Abiomed Presents Results from USpella; First U.S. Registry Data Evaluating 181 Patients from 16 Centers with IRB Approval…; Abiomed Reports Results from Academic Medical Center’s Three-Year Follow-up of MACH II Trial…
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Flashbacks: Impella 2.5 Heart Pump Performs Well in a Feasibility Trial; FDA OK’es Impella 5.0 and Impella LD Circulatory Assist Devices; Impella 2.5 Heart Pump Given Green Light in US; Impella Percutaneous VAD to be Studied for Acute MI Patients; impella® recover LV