A Medical Device Daily

The Recover System pumps made by Impella (Aachen, Germany) are designed to provide left ventricle support for patients suffering from reduced cardiac output, according to the company, and can aid in recovering the hearts of patients suffering from an acute myocardial infarction or (AMI) heart attack, including those who have gone into cardiogenic shock (CS).

The company’s systems received praise from Martin Leon, MD, chairman of the Cardiovascular Research Foundation (New York), a well-known thought leader in the cardiovascular arena.

In a statement, Leon said, “Clinical data indicates that early interventional reperfusion and mechanical support is essential to heart recovery following an AMI. However, only 1% of AMI patients are referred to surgery for VAD [ventricular assist device] implantation. Impella’s pumps provide cardiologists with a simplified minimally invasive option for left ventricular support in the cath lab, enabling earlier initiation of the healing process, thereby lessening the need for subsequently more invasive procedures in many patients.”

In addition, said Leon, “the Impella systems have the unique potential to become a standard part of any high-risk cardiovascular procedure being performed in the cath lab, including advanced complex angioplasty, by providing needed hemodynamic support and helping to reduce procedural complications.”

Patients typically suffer from cardiogenic shock with-in a few hours after an AMI, and they normally are administered inotropic drugs in combination with the insertion of an intra-aortic balloon pump to improve heart function and to aid blood flow.

While an intra-aortic balloon pump can increase blood flow from the heart, it does not unload blood from the left ventricle, which is necessary for effective recovery. Additionally, the strain resulting from multiple high doses of inotropic drugs tends to diminish the likelihood of recovering the patient’s natural heart.

As an alternative, an Impella pump is inserted percutaneously into the left ventricle to help restore blood flow and improve the chance for recovery of the patient’s natural heart.

AMI is estimated to occur in about 865,000 patients annually in the U.S., about 1 million worldwide, and an estimated 7% to 10%, or 159,000 cases, go into CS, resulting in death more than 50% of the time.

Impella said that it believes “the clinical mindset is changing from measuring success in terms of mortality to measuring success in terms of natural heart recovery.”

About 100,000 people in the U.S. and 18,000 in Japan receive intra-aortic balloon pumps as a part of acute cardiac treatment each year. In addition, in the U.S. alone, about 1 million procedures are conducted annually in the cath lab, of which 5%-10% are considered to be high-risk procedures that could benefit from a circulatory assist device.

Besides heading the Cardiovascular Research Foundation, Leon is associate director of the Center for Interventional Cardiovascular Research and professor of medicine at New York Presbyterian Hospital/ Columbia University Medical Center.