Japanese Registry Studies Show Survival Benefit of Abiomed's Impella-Supported Treatment of Cardiogenic Shock Patients

September 20, 2022—Abiomed announced two presentations of results from a 3-year, investigator-led study of all Impella-supported patients treated at 109 hospitals in Japan. Investigators used the Japanese Registry for Percutaneous Ventricular Assist Devices (J-PVAD; N = 1,344) to assess the efficacy and safety of Impella.

The first study showed a 30-day survival rate of 81% for 293 consecutive acute myocardial infarction (AMI) cardiogenic shock patients treated with Impella heart pumps.

The second study showed a 30-day survival rate of 77% for 143 consecutive patients with cardiogenic shock caused by myocarditis who received Impella support or Impella plus venoarterial extracorporeal membrane oxygenation (VA-ECMO) support, known as ECpella.

By contrast, historical cardiogenic shock survival rates without Impella are approximately 50%, noted the company.

The J-PVAD registry was conducted by 10 Japanese professional societies. J-PVAD data are independently monitored and shared with the Japan Pharmaceuticals and Medical Devices Agency.

The two data sets were presented at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts.

The new results update an interim analysis that was delivered in July 2020 at the 84th annual meeting scientific meeting of the Japanese Circulation Society, held online.

Abiomed advised that the results of Impella-support treatment of AMI cardiogenic shock patients are consistent with other published investigator-led studies, that have demonstrated significant increases in survival with the use of Impella and best practices such as placing Impella before percutaneous coronary intervention.

Junya Ako, MD, lead investigator in the study of AMI patients, commented in Abiomed’s press release, “The results of this study demonstrate that when Impella is used and best practices are followed, it is possible to achieve heart recovery and > 80% survival rates for patients with AMI cardiogenic shock.” Dr. Ako is an interventional cardiologist and chair of the department of cardiovascular medicine at Kitasato University Hospital in Kanagawa, Japan.

Discussing the study of the of treatment patients with cardiogenic shock caused by myocarditis, lead investigator Koichi Toda, MD, stated, “These findings further demonstrate the potential of increasing native heart recovery in myocarditis patients through the use of Impella, which is an important consideration given the limited number of heart transplants.” Dr. Toda is a cardiovascular surgeon in the department of cardiovascular surgery at Osaka University Graduate School of Medicine in Osaka, Japan.

The company noted that a previous systematic review and meta-analysis evaluating the impact of etiology on 29,289 patients with cardiogenic shock supported only with VA ECMO found 48% survival at 30 days. Ana C. Alba, MD, et al published the meta-analysis findings in Journal of Heart and Lung Transplantation (2021;40:260-268).

According to Abiomed, a US Centers for Disease Control and Prevention report showed that rates of myocarditis have increased since the start of the COVID-19 pandemic to approximately 146 cases per 100,000 people, up from < 10 cases per 100,000 people. The same report also showed that patients with COVID-19 had approximately 16 times the risk for developing myocarditis compared to patients who did not have COVID-19.

Masahiro Ono, MD, a cardiovascular surgeon at Methodist Healthcare in San Antonio, Texas, stated in the Abiomed press release, “Myocarditis is a growing epidemic in the COVID-19 era. It is exciting to see data from this study demonstrates the potential for Impella support to improve patient outcomes in this very sick patient population.”

In August 2020, the company announced that the FDA issued an emergency use authorization (EUA) for left-sided Impella heart pumps to provide left ventricular (LV) unloading and support to COVID-19 patients who are undergoing ECMO treatment and develop pulmonary edema or myocarditis.

Abiomed’s Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, and Impella 5.5 with SmartAssist are FDA approved to treat heart attack or cardiomyopathy patients in cardiogenic shock and enable native heart recovery.

Impella LV support systems are also authorized for emergency use by health care professionals in the hospital setting for providing temporary (≤ 4 days for Impella 2.5, Impella CP, and Impella CP with SmartAssist; and ≤ 14 days for Impella 5.0 and Impella 5.5 with SmartAssist) LV unloading and support to treat critical care patients with confirmed COVID-19 infection who are undergoing ECMO treatment and who develop pulmonary edema while on VA ECMO support or late cardiac decompensation from myocarditis while on venovenous ECMO support.

The authorized Impella LV support systems have neither been cleared or approved for the authorized indication for use.

The Impella RP and Impella LV support systems have been authorized for the above emergency use by FDA under an EUA and have been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, stated Abiomed.