July 30, 2020
Survival Rates With Abiomed's Impella Heart Pump Evaluated in Japanese Registry
July 30, 2020—Abiomed announced that a 3-year, investigator-led, prospective study of Japanese patients who received an Impella heart pump showed that use of the device is associated with a 77% survival rate at 30 days in acute myocardial infarction (AMI) cardiogenic shock patients. By comparison, the company noted, the historic survival rate for cardiogenic shock is approximately 50%.
The study used the Japanese Registry for Percutaneous Ventricular Assist Devices (J-PVAD) to investigate the efficacy and safety of Impella. Lead investigator Yoshiki Sawa, MD, presented the interim analysis as a late-breaking clinical study at the 84th annual meeting scientific meeting of the Japanese Circulation Society (JCS), held as an online conference July 27 to August 2.
According to Abiomed, the interim analysis examined 819 patients treated with Impella for a variety of conditions, including cardiogenic shock and fulminant myocarditis, at 109 hospitals in Japan. Other findings include that Impella therapy is a highly effective treatment for fulminant myocarditis, with an 88% survival rate at 30 days. The investigators concluded that favorable 30-day survival data indicate Impella is a beneficial therapy.
“[These] data demonstrate early use of Impella in drug-resistant acute heart failure patients can consistently achieve high rates of survival and native heart recovery for those in cardiogenic shock and other serious life-threatening conditions,” commented Dr. Sawa in Abiomed’s announcement. “This was accomplished by closely following best practices for Impella use. I thank my colleagues in the Japanese clinical community for following protocols and guidance from the Impella Committee to safely introduce a new therapy for the benefit of our patients.” Dr. Sawa is a professor at the Department of Cardiovascular Surgery at Osaka University Graduate School of Medicine in Osaka, Japan, and president of the Japanese Association of Thoracic Surgery.
The J-PVAD registry study is overseen by the Council for Clinical Use of Ventricular Assist Device Related Academic Societies, which is composed of 10 Japanese professional societies including JCS. J-PVAD data is independently monitored and shared with the Japan Pharmaceuticals and Medical Devices Agency.
Abiomed noted that the comparatively high survival rates with Impella were achieved by following established best practices that include placing Impella preprocedure in percutaneous cardiovascular interventions, identifying cardiogenic shock early, using a right heart catheter, and reducing the use of inotropes. In an online video, Dr. Sawa and Abiomed’s Chief Medical Officer, Chuck Simonton, MD, discuss how the use of Impella and best practices helped Japanese physicians achieve high survival rates. The company stated that native heart recovery with Impella is a cost-effective therapy of particular importance in Japan, a country with a limited number of heart transplants.
Additionally, the company advised that the study’s findings of the use of best practices are consistent with other published investigator-led studies, such as the National Cardiogenic Shock Initiative Study (NCSI), that have demonstrated significant increases in survival with the use of Impella best-practice protocols. William O’Neill, MD, principal investigator of the NCSI Study, commented in Abiomed’s press release, “This encouraging study demonstrates, when known best practices are followed, significant improvements in cardiogenic shock survival rates can be achieved with use of Impella. I encourage physicians around the world to take note of the Japanese data, which demonstrates the rationale for early use of Impella in cardiogenic shock patients.”