Dr. Harish Manyam revolutionizes cardiac care with innovative device

Harish Manyam, MD, is on a mission to improve the lives of people with heart problems. His recent achievement of implanting the first leadless atrial pacemaker in Tennessee is a step in that direction, marking a significant advance in cardiac care and promising safer, more effective treatment for patients.

A wireless pacemaker combined with an innovative subcutaneous defibrillator creates a breakthrough system that solves potentially dangerous problems associated with traditional pacemakers and defibrillators.

“This is a huge step forward for the field,” said Dr. Manyam, interim chair of the Department of Medicine in the College of Medicine at the University of Tennessee Health Science Center in Chattanooga and chief of cardiology at Erlanger Health System. “We’ve always tried to do things in a way that can save patients’ lives, but now we’re thinking about ways to prevent complications in patients so they can live longer, healthier lives, which is really our mission at UT Health Science Center.”

The new system was developed based on an international study described in a paper co-authored by Dr. Manyam and published in the New England Journal of Medicine.

One of the main problems with traditional pacemakers and defibrillators is infection, which requires removal of the electrodes, the insulated wires that deliver electrical impulses to the heart.

“Traditionally, we would implant the devices under the skin near the left collarbone and we would run these wires from the device through a blood vessel and attach them to the heart muscle inside the heart,” Dr. Manyam said. “What we saw, doing that over the years, was that people would develop infections in their bloodstream, and infection rates would be as high as 20 percent, as a result of infection somewhere else in the body. When patients had these infections, the bacteria would get into the bloodstream and grow on the wires that we were implanting, and the only way to really get the bacteria out of the body was to remove the wires themselves.”

Another problem is that these flexible wires can break, which also requires removal from the body. Removing the wires is a risky procedure that requires specialized equipment, and the risks increase the longer the wires remain in the body and the more they grow into heart tissue and blood vessels, Dr. Manyam said. The goal of these new devices is to eliminate the need for the wire removal procedure.

In the new system, a subcutaneous defibrillator is inserted into the left side of the body near the chest. The wire runs under the skin and sits above the sternum, so neither part touches the bloodstream. A wireless pacemaker, about the size of an AA battery, is inserted into the leg, guided through a femoral vein and attached to the inside of the heart. The two devices communicate wirelessly to correct dangerous heart rhythms without having to shock the patient.

“The goal was to see if the two devices could work together, and we found that they could,” Dr. Manyam said. “When the wireless pacemaker detects a dangerous heart rhythm, it can respond to that event, it can deliver an antitachycardia pacing device, and it can respond to the defibrillator that it’s doing that, so the defibrillator doesn’t shock the patient. If that doesn’t work, the pacemaker will tell the defibrillator, and the defibrillator will shock the patient.”

“It’s a testament to the fact that both UT Health Science Center and Erlanger are working together to provide really high-level research opportunities within the state.”

Dr. Harish Manyam

The achievement is the result of more than a decade of development. The study, led by Dr. Reinoud Knops, MD, PhD, of the Department of Cardiology at Amsterdam University Medical Center, involved dozens of researchers from around the world. Dr. Manyam joined the development of the subcutaneous defibrillator and taught other doctors how to implant and use the device. Initially, doctors from around the country traveled to Chattanoga for training, until Dr. Manyam and his team developed a virtual simulator to make training more accessible to more doctors.

“We’re really proud. This was a multi-site study, funded by Boston Scientific, with a lot of people involved to make sure it worked,” Dr. Manyam said. “It’s a testament to both UT Health Science Center and Erlanger working together to make sure we can bring really high-end research to the state. So, it was one of the highlights of my career to do this study and be a part of it.”

The process and outcome of this study underscore why Dr. Manyam chose a career in medicine: “to help people,” he said. That motivation also led him to join Erlanger and the College of Medicine in Chattanooga. Dr. Manyam was particularly interested in the educational aspect, as well as the cutting-edge research and advanced cardiology care offered to the community.

“The advantage of doing research here is that you have the support of both Erlanger and the University of Tennessee Health Science Center to really advance the research and also teach our residents, medical students and fellows,” he said. “One of the things that makes me excited about being a physician every day is that I get to work with people who are learning, and I get to teach them different concepts that they don’t know, and hopefully instill in them a good work ethic and a basic belief that they can take care of a lot of other people.”

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