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Allegheny General Hospital Leads Local Clinical Trial for New Heart Pump

Monday, August 31, 2015

Cardiac surgeons at Allegheny General Hospital (AGH), part of the Allegheny Health Network, announced today that they have become the first medical team in western Pennsylvania to implant the latest version of a left ventricular assist device (LVAD) in a heart failure patient.

AGH is the only hospital in the region participating in Thoratec’s national MOMENTUM 3 Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate 3™. The experimental HeartMate 3 device is designed to improve survival and quality of life for patients awaiting a heart transplant as well as those who are not candidates for transplantation and require a permanent therapeutic option.

LVADs take over the pumping action of a left heart ventricle that is not functioning properly due to cardiovascular disease or injury. The mechanical pump is surgically implanted to assist the weakened heart muscle, enhancing its ability to move oxygen-rich blood throughout the body.

“Currently, there are about 3,000 to 4,000 LVAD devices implanted every year, including about 40 to 50 at AGH,” said Stephen Bailey, MD, the Director of Cardiac Surgery at AGH who performed the procedure. “If this new device shows superior patient outcomes and better durability, it has the potential to help even more of the hundreds of thousands of people who suffer and die from heart failure every year in this country.”

Heart failure affects 6 million Americans annually, according to the American Heart Association, with the number expected to rise to 8 million in the next 15 years. It is the nation’s and western Pennsylvania’s leading cause of hospitalization among people over the age of 65.

While the next-generation HeartMate 3 device provides the same level of pumping support as the Food and Drug Administration (FDA)-approved HeartMate II that is currently in use at AGH and other major  heart centers around the country, HeartMate 3 advances the design of the existing device in a number of key areas, including:

• Its considerably smaller size, allowing the pump to be placed in in the pericardial space (the fibrous tissue that surrounds the heart), rather than the more invasive creation of a pocket in the chest that is required for implantation of the Heartmate II LVAD.

• Its durability. The device is magnetically levitated, meaning its parts float instead of rubbing together, eliminating contact and friction in the rotor.

• Its wider pathways for blood flow, which causes less trauma for the red blood cells and could mean reduced chances of blood clotting and bleeding.

“The new device also induces a pulse, which helps the heart deliver greater blood flow in a more physiologic and natural way,” said Raymond Benza, MD, Director of the Heart Failure, Transplantation and Mechanical Circulatory Support Program at AGH. “By periodically alternating the speed of the pump, it more accurately mimics a natural pulse. In theory, by alternating blood flow through the pump, it is less prone to have areas of blood flow stagnation and also fewer problems with aortic valve insufficiency.”

Patients with the HeartMate 3 LVAD wear an external control system with a battery that powers the pump. The external system, carried in small fanny pack worn around the waist, is connected to the implanted pump through a small portal in the abdomen. The system has a wide range of operation and is able to pump up to 10 liters of blood per minute – equivalent to the output of a healthy heart.

Approximately 3,000 people in the United States are currently awaiting a heart transplant, but just 2,000 transplants are performed annually due to a lack of available donors and other possible complications. AGH doctors helped to pioneer the use of heart assist devices as a bridge to transplantation as well as destination – or permanent – therapy for those who are not good candidates for transplant.

“While the number of patients diagnosed with advanced heart failure continues to rise, there unfortunately has not been a corresponding increase in the number of donor hearts,” said Srinivas Murali, MD, a heart failure specialist and Director of Allegheny Health Network's Cardiovascular Institute. “LVADs have become an extremely vital and proven alternative therapy for the most severely ill heart failure patients – and one that only the most experienced and specialized medical centers are capable of providing. We are proud to be one of a select group of leading hospitals across the country – and the only hospital in western Pennsylvania – participating in this important clinical trial.”

Ideal participants for the Momentum 3 study at AGH are individuals who have difficult-to-manage heart failure symptoms while on optimal guideline-based medical treatment; are unable to perform physical activity without discomfort; feel a decline in their quality of life because of heart failure; and have been hospitalized for heart failure symptoms more than once in the past six months. In this randomized, un-blinded study, qualifying participants will receive either a HeartMate 3 or HeartMate II device.

The Momentum 3 trial plans to enroll more than 1,000 participants at up to 60 trial sites. For more information about the trial at AGH, please contact Amanda Hopwood at ahopwood@wpahs.org or call 412.359.4018.