New Heart surgery Technique Performed 1st in US at Strong Gets FDA OK

Pioneering efforts by UR Medicine cardiac surgery teams led to FDA approval of a new technique for implanting a life-saving heart pump. The procedure, performed first in the nation at Strong Memorial Hospital, is less invasive, making recovery easier for people with advanced congestive heart failure.

Using this alternate approach, surgeons attach the HeartMate 3 left ventricular assist device (LVAD) to the heart using two small incisions, avoiding the need to open the sternum, or “crack the chest.” The device, made by Abbott, supplements the pumping action of a weakened heart, and studies show using this technique allows patients to heal faster.

“When you are doing pioneering work and the FDA’s rigorous review process leads to approval, that’s huge,” said cardiologist Jeffrey Alexis, M.D. He is medical director of the UR Medicine Heart & Vascular LVAD program, one of the largest and most successful in the country.

“We expect as leading heart centers adopt this implant technique, patients with heart failure will recover faster with improved quality of life, which is our goal every day.” 

LVADs are a vital component of advanced heart failure care, which Strong heart failure specialists began using in 2001. However, it is difficult for some people with advanced heart failure to endure traditional open surgeries, because recovery is long and painful as the chest bone heals.

Igor Gosev, M.D., surgical director of the LVAD program, learned European physicians had successfully implanted the device without opening the sternum, and was anxious to provide it for patients in Upstate New York. 

The HeartMate 3 is smaller than previous LVADs, making it ideal for a sternal-sparing implant approach. 

Gosev and Peter Knight, M.D., an expert in minimally invasive heart surgery, gathered a team to perfect the technique and introduced it at Strong Memorial in February 2018.

“Our patients do very well with this surgery and we look forward to seeing the positive impact it will have on people with advanced heart failure as other centers around the country begin to offer it,” Gosev said.

More than 100 people have received pumps this way and outcomes are positive. Patients have shorter hospitalizations, fewer complications and less pain, all contributing to faster recovery and return to their normal routine. Earlier this year, a man from the Buffalo area returned home just four days after the surgery. That’s about a week sooner than patients who have the open surgery.

The team published two studies demonstrate its benefits and providing valuable evidence for the FDA to consider.

“In the beginning we were anxious but our patient outcomes have been positive,” said Knight, the Marjorie B. Morris Endowed Professor in Cardiac surgery. “Impact of FDA approval means it’s going to open up the opportunity for us to expand our national reputation for excellence in minimally invasive surgeries as we train surgeons to do sternal-sparing HeartMate 3 implant.”

National LVAD leaders

More than 5.7 million people in the U.S. suffer from heart failure and approximately 915,000 new patients are diagnosed each year. Advanced congestive heart failure treatment options are limited, but LVADs with or without heart transplantation help to extend survival.

“When people are facing this disease, the opportunity to have a better quality of life is critically important. LVAD technology has offered a significant advance in their care,” Alexis said.

Strong Memorial is home to one of the top 10 centers for LVAD use in the country. The heart failure team participated in early clinical studies, dating back to 2001, that led to standard use of the pumps. And last year, after a large clinical trial including many Strong Memorial patients, the HeartMate 3 was approved for long-term use.

“Our VAD team has more than 200 years of combined experience working with these pumps. Their knowledge and expertise is essential to providing our patients the best possible outcomes,” said Sunil Prasad, M.D., chief of Cardiac surgery and the Dr. Jude S. Sauer Family Distinguished Professor in Cardiac surgery.

Over the past 20 years, nearly 700 people from across Upstate and Western New York and Pennsylvania have received these high-tech devices at UR Medicine’s Strong Memorial.