New left ventricular assist system offers a bridge to transplant while reducing risks of traditional left ventricular assist devices

Penn State Health Milton S. Hershey Medical Center is currently participating in the COMPETENCE trial, a study to evaluate the EVAHEART2 Left Ventricular Assist System (LVAS) for the treatment of heart failure. The device can be used as a destination therapy and as a support for transplant, while decreasing some of the risks associated with left ventricular assist devices.

Heart failure affects more than 6 million adults in the U.S. with current treatment options for worsening heart failure including open-heart surgery for transplantation implantation or placement of an LVAD (PSHN). Both treatment options come with a risk of gastrointestinal bleeding and stroke for LVAD placement.

The EVAHEART2 Left Ventricular Assist System was designed to reduce the risk of post-implantation stroke, which affects approximately 8% of heart failure patients with LVAD implantation (PSHN). EVAHEART devices are made with an open-vane hydrodynamic impeller with large blood flow gaps. The design allows for preserved aortic pulsatility, low operational rpm, low shear stress, minimal blood trauma and a low likelihood of thrombosis.¹

“Imagine inserting the tip of a vacuum cleaner into the left ventricle of the heart to get the blood to the pump and out to the rest of the body; sometimes the tip can move into an incorrect position even after proper surgical placement and can create suction against the walls of the heart,” explained Dr. Robert Dowling, cardiothoracic surgeon and director of heart device research at Penn State Heart and Vascular Institute and Penn State College of Medicine. “This may cause blood clots that could cause strokes. This new device was designed in such a way that there is no tip, but rather the ‘vacuum’ hose itself is surgically attached directly into the lining of the walls of the heart, removing the need for a tip and thereby potentially reducing the risk of a stroke.”

Another important feature that sets it apart from other pump devices is its ability to create a pulse, which is necessary for maintaining the health of organs and arteries. Dowling said it also “chews up the blood less, and people have less bleeding problems, which can be really big problems with other pumps.”

The Milton S. Hershey Medical Center was the second hospital in the nation to implant the newly designed mechanical pump. There are 40 clinical sites and 399 patients involved in the prospective, randomized, multi-center study to evaluate EVAHEART2 through 2022.²

“To be one of the first in the nation to use this new LVAD technology is an incredible opportunity for patients in central Pennsylvania and puts us at the forefront of cardiac research in the region,” Dowling said. “Our patients are doing great, and we’re psyched about it.”

General study inclusion criteria:³

• Age ≥ 18 years
• Left ventricular Ejection Fraction (LVEF) ≤ 25%
• NYHA Class IV heart failure

Exclusion criteria:³

• Active, uncontrolled infection
• Severe end-organ dysfunction or failure
• History of organ transplant
• Prosthetic mechanical aortic valve that will not be converted to a bioprosthesis
• Patients with an unacceptable risk for successful LVAD implantation and maintenance
• Patients refusing blood transfusion
• Intolerant of anticoagulation therapy
• Active psychiatric disorder, irreversible cognitive dysfunction, or other psychosocial behavior that impairs the ability of the patient to follow instructions, maintain their device or medical regimen
• Pregnancy
• Current dependence on other mechanical circulatory support devices at the time of implant, other than IABP and Impella 5.0/5.5
• Presence of condition(s) other than heart failure that would limit survival to less than 24 months

Hershey Medical Center currently has more than 40 ongoing cardiovascular clinical research studies underway.

“Penn State Health is committed to giving patients access to leading-edge cardiovascular treatments,” Dowling said. “The care provided by our nurses, research team, intensive care unit team and cardiologists is second to none.”

References

1. Bartoli C, Dowling R. The Next Wave of Mechanical Circulatory Support Devices – Cardiac Interventions Today. Cardiac Interventions Today. https://citoday.com/articles/2019-jan-feb/the-next-wave-of-mechanical-circulatory-support-devices. Published 2019. Accessed December 30, 2021.
2. Hershey Medical Center second in the nation to implant next-generation heart device – Penn State Health News. Penn State Health News. https://pennstatehealthnews.org/2021/02/hershey-medical-center-second-in-the-nation-to-implant-next-generation-heart-device/. Published 2021. Accessed December 30, 2021.
3. History of Changes for Study: NCT01187368. Clinicaltrials.gov. https://clinicaltrials.gov/ct2/history/NCT01187368?V_20=View. Published 2021. Accessed December 31, 2021.