The Impella heart pump is an FDA approved, temporary ventricular support device designed to provide hemodynamic support to a patient with depressed heart function. The device is approved for use in "high-risk percutaneous coronary intervention (PCI)" and in instances where a patient is suffering from cardiogenic shock following a heart attack or an open heart surgery procedure. The catheter-based heart pump is manufactured by Abiomed, Inc., headquartered in Danvers, Massachusetts, and has been used in more than 45,000 procedures since 2008. The Impella 2.5™ device is the world's smallest heart pump. The whole device is less than the length of a pencil, and the pump is thinner than an eraser, allowing it to be placed into the heart through a peripheral artery. Once in place, the Impella devices pump blood for the left or right side of the heart, pumping blood into the ascending aorta or pulmonary artery, respectively. The Impella heart pump is designed to rest the patient's heart during an elective or high-risk PCI procedure and prevents the heart from being overstressed by the procedure as coronary artery blockages are repaired. It also maintains blood flow and blood pressure during the procedure. . In the setting of advanced heart failure, a PCI procedure with an Impella heart pump has the ability to improve quality of life in patients who sometimes have no other options to improve their heart function.
Contents
- Heart Recovery
- Impella Technology
- Left sided Hemodynamic Support
- Applications of the Impella
- Right sided Hemodynamic Support
- References
Impella heart pumps are also FDA approved in the setting of cardiogenic shock. Cardiogenic shock is a life-threatening condition in which the heart cannot pump enough blood or oxygen to the body's vital organs, usually as the result of a heart attack. In this setting, Impella heart pumps can reduce the heart's workload, supply oxygen to the end organs, and allow for recovery of the native heart.
Heart Recovery
Impella pumps offer a unique ability to stabilize the patient's hemodynamics before or during a PCI procedure and unload the heart, allowing the muscle to rest and potentially recover its native function. Heart recovery is the ideal option for a patient's quality of life and, as documented in several clinical papers, has the ability to reduce costs for the healthcare system.
As of 2016, more than 45,000 patients have been supported by Impella devices. Cited in more than 300 publications, Impella is the most studied percutaneous circulatory support device available today.
Impella Technology
Impella heart pumps are percutaneous microaxial pumps that act as mechanical circulatory support (MCS) devices in patients in need of hemodynamic support. The pumps are mounted on a 9 Fr support catheter. The pumps are inserted by a physician typically through femoral artery access, although axillary and subclavian artery approaches are not uncommon. Upon proper placement within the patient, the Impella cannula crosses the arotic valve, leaving the blood inflow cage completely within the left ventricular chamber and the outflow cage (and pump housing) in the ascending aorta. [FIG 2 FIG 3] The pump continuously aspirates blood from within the ventricle directly into the aorta above the aortic valve. Power is connected to the pump motor and sensors through connections within the guiding catheter. In turn, the catheter is connected to an external dedicated control console, called the Automated Impella Controller, which houses an integrated pump controller and purge system.
The Impella 2.5™ heart pump is capable of pumping 2.5 L/min of blood percutaneously. The Impella CP™ heart pump is a more powerful version of the Impella 2.5 and is a capable of pumping up to 3.5 L/min. The Impella 5.0™ heart pump is a larger pump and is inserted into the left ventricle by femoral cutdown or though the axillary artery and can provide up to 5.0 L/min of blood flow.
Left-sided Hemodynamic Support
The Impella heart pumps are designed to provide hemodynamic support when the patient's heart is unable to produce sufficient cardiac output. The Impella family of heart pumps can supply 1.0 L/min-5.0 L/min of blood flow, depending on the size and power setting of the individual pump. The physiological consequences of left-sided support are threefold. First, it unloads the left ventricle by reducing left ventricular end-diastolic volume and pressure, which decreases ventricular wall stress. Subsequently, left ventricular work and myocardial oxygen demand decrease. Second, Impella pump flow increases mean arterial pressure, diastolic pressure, and cardiac output. This increases cardiac power output and cardiac index. The combined effects of the Impella on wall stress and perfusion pressure (especially diastolic pressure) augment coronary perfusion. Lastly, augmented cardiac output and forward flow from the left ventricle has secondary benefits related to right ventricular function. Impella support decreases pulmonary capillary wedge pressure and reduces right ventricular afterload.
Applications of the Impella
In June 2008, the Impella 2.5 heart pump received FDA 510(k) clearance for partial circulatory support for periods of up to 6 hours during cardiac procedures not requiring cardiopulmonary bypass. In March 2015, the Impella 2.5™ heart pump received FDA Premarket Approval (PMA) for elective and urgent high-risk PCI procedures, and in December 2016, the FDA PMA was expanded to include the Impella CP™ heart pump. In April 2009, the Impella 5.0 and Impella LD™ heart pumps received FDA 510(k) clearance for circulatory support for periods of up to 6 hours during cardiac procedures not requiring cardiopulmonary bypass. In July 2010, the Automated Impella Controller received FDA 510(k) clearance for intended use by trained healthcare professionals in healthcare facilities and medical transport (ie, ambulance, helicopter, or fixed-wing aircraft) environments.
A recent Yale University study published in the Journal of the American College of Cardiology entitled "National Trends in the Utilization of Short-term Mechanical Support," found a more than 1500% increase in the use of minimally invasive percutaneous MCS devices of between 2007 and 2011. As of 2016, 1000 hospitals in the United States have acquired Impella products, helping more than 37,000 patients.
In April 2016, the Impella 2.5™, Impella CP™, Impella 5.0™, and Impella LD™ received FDA PMA to provide treatment of ongoing cardiogenic shock for periods up to 4 days in the case of the Impella 2.5™ and Impella CP™ and for periods up to 6 days in the case of the Impella 5.0™ and Impella LD™. The FDA PMA recognized the Impella system as a therapy that allows hearts to recover function after insult.
The Impella pump is now included in 7 sets of clinical practice guidelines:
- Percutaneous Coronary Intervention
- Cardiogenic Shock
Right-sided Hemodynamic Support
In January 2015, the Impella RP™ was granted a Humanitarian Device Exemption (HDE) to provide circulatory assistance for patients who develop right heart failure. The Impella RP is the first percutaneous single access heart pump designed for right heart support. The pump is inserted through a standard catheterization procedure via the femoral vein, into the right atrium, across the tricuspid and pulmonic valves, and into the pulmonary artery. Upon insertion, the Impella RP is situated such that the inflow area sits in the inferior vena cava and the outflow area is within the pulmonary artery above the pulmonic valve. The Impella RP is capable of delivering >4 L/min of blood flow. Currently, it is indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients with a body surface area of ≥1.5 m2 who develop right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.