Hackensack University Medical Center was the first hospital in the U.S. to perform procedures using the Impella 5.5 and is involved in pioneering research and advanced clinical trials.
In October 2019, Hackensack Meridian Hackensack University Medical Center became the first hospital in the U.S. to successfully perform a cardiovascular surgery procedure using the new Impella 5.5 with SmartAssist technology. Only a few hospitals in the country have access to this new device; Hackensack University Medical Center has been involved in prospective research and will soon launch a clinical trial to study patient outcomes after device implantation.
Increased Benefits to Patients
The Impella 5.5, which is the newest and most powerful of five heart pump devices manufactured by Abiomed, is being introduced in the U.S. through a controlled rollout at select hospitals with established heart recovery protocols.
The device received pre-market approval (PMA) from the U.S. Food and Drug Administration (FDA) to treat cardiogenic shock, a severe condition that can occur after a heart attack, open-heart surgery, or as a result of cardiomyopathy. The cardiogenic shock causes the heart to be too weak to pump enough blood to meet the body’s needs effectively. At Hackensack University Medical Center, physicians in our Acute Cardiogenic Shock Program — which incorporates the expertise of interventional cardiologists, heart failure specialists, and cardiac surgeons — use the device to rest the heart and allow it to recover after cardiogenic shock. The Impella 5.5 temporarily assists the pumping function of the heart and can be used for up to 14 days, ensuring that the heart can pump enough blood for the body while reducing strain on the heart during recovery.
Impella 5.5. functions similarly to a surgically implanted left ventricular assist device (LVAD), but it can be inserted during a more minimally invasive procedure. In contrast to the open-chest, invasive sternotomy, or left ventricle coring required to implant an LVAD, the Impella 5.5 pump is surgically inserted into the axillary artery under the patient’s clavicle through a small incision in the chest. The Impella 5.5 also can be inserted directly into the anterior aorta during open cardiac surgery.
In addition to a more minimally invasive surgical approach, the device offers patient benefits, including:
• Forward flow design means that it effectively pumps blood at a peak flow of greater than 6 liters per minute and maintains blood supply to vital organs.
• Fully unloading design, which means that it reduces the work and oxygen demands placed on the heart.
• A thinner, shorter motor housing than previous Impella models, and a fiber optic pressure sensor allow for easier pump insertion and precise positioning.
• SmartAssist technology that provides data such as left ventricular pressure (LVP), end-diastolic pressure (EDP), and cardiac power output (CPO) to help physicians make critical patient-care decisions.
• Impella Connect allows clinicians to securely and remotely monitor patient data collected by the pump 24/7 through any internet-connected device.
Another benefit of the Impella 5.5 is that it provides improved patient mobility, allowing patients to get up and walk around after the device is in place — promoting faster healing and speeding the recovery process.
Research and Clinical Trials
The team at Hackensack University Medical Center has performed approximately 30 procedures using the Impella 5.5. In a paper entitled ‘New Surgical Circulatory Support System Outcomes’ published in ASAIO Journal, my colleagues and I present the outcomes of 55 patients who underwent an Impella 5.5 implant at Hackensack University Medical Center, Cleveland Clinic, and Cedars-Sinai Medical Center.
Using data from the manufacturer’s quality database of all Impella 5.5 implants at the three centers, our research showed that 35 patients (63.6 percent) were successfully weaned off the device with the recovery of native heart function. Eleven patients (20 percent) were bridged to another therapy. Based on early experiences with device implantation in the U.S., the paper reported that 83.6 percent of patients survived to explant, with 76.1 percent recovering native heart function.
To further expand on this research, Hackensack University Medical Center will participate in a multicenter, national clinical trial called SURPASS (Surgical Unloading Renal Protection and Sustained Support). The clinical trial aims to enroll 1,000 patients across 25 U.S. centers and analyze outcomes associated with the Impella 5.5.
Hackensack University Medical Center is committed to providing its patients with the most advanced cardiovascular care options using state-of-the-art approaches and the latest devices. The Impella 5.5 is another pioneering, potentially life-saving treatment option that our team can offer to promote heart recovery and possibly avoid the need for further, more invasive treatments.