Friday, Nov 8, 2024

Holston Valley becomes first hospital in Appalachian Highlands to use leading-edge defibrillator to treat patients with abnormal heart rhythms 

Medtronic Aurora EV-ICD™ system offers alternative to traditional, transvenous devices

Physicians at Holston Valley Medical Center are the first in the Appalachian Highlands to successfully implant a novel extravascular defibrillator to treat patients with dangerously fast heart rhythms, as well as those at risk for developing these rhythms.

The Medtronic Extravascular Implantable Cardioverter-Defibrillator (EV-ICD) system recently received FDA approval and is composed of the Aurora EV-ICD™ MRI SureScan™, the Epsila EV™ MRI SureScan™ defibrillation lead and proprietary implant tools. The first Aurora EV-ICD system implants within Ballad Health were successfully performed by Ballad Health CVA Heart Institute physicians Shaun Colburn, MD, a cardiac electrophysiologist, and Stanley Gall, MD, a cardiothoracic surgeon, at Holston Valley on Tuesday, July 2.

The Aurora EV-ICD™ MRI SureScan™ Model DVEA3E4 device is used for treating patients who have experienced, or are at significant risk of developing, life-threatening ventricular tachyarrhythmias (a faster-than-normal heart rhythm) through the delivery of antitachycardia pacing (ATP), cardioversion and defibrillation therapies.

If the heart is beating too fast or is not beating regularly, the device can send small electrical signals to correct the heart rate. This type of “pacing the heart” is called antitachycardia pacing (ATP). If the fast heartbeat continues, the device then sends an electric shock to reset the normal heartbeat. ATP is also used in the treatment of ventricular arrhythmias (abnormal heart rhythms that originate in the heart’s lower chambers), whether slow or fast. This treatment reduces the number of unnecessary shocks and improves patient’s quality of life.

“Embracing innovation is crucial to delivering the highest standard of patient care and continually improving the health and well-being of our community, and being the first hospital in this region to use the Aurora EV-ICD system to treat patients with abnormal heart rhythms underscores our pursuit of that goal,” said Rebecca Beck, CEO of Holston Valley Medical Center. “This groundbreaking technology allows us to provide advanced care and better outcomes for our patients, and it continues Holston Valley’s longstanding reputation as a leader in cardiovascular advancements."

The Aurora EV-ICD system is a first-of-its-kind defibrillator, which offers a single device, single procedure with a lead placed outside of heart and veins. Implanted below the left armpit (in the left mid-axillary region) and the lead is placed under the breastbone (sternum) using a minimally invasive approach.

“The Aurora EV-ICD system allows us to offer patients the benefits of traditional ICDs, while reducing certain risks that come with placing leads in the heart or veins,” Dr. Colburn said. “We strive to deliver high-quality care, close to home, and this technology is another step forward in providing our patients with the latest clinical advancements to manage their cardiac conditions.”

In addition to Dr. Colburn, Muralidhar Papireddy, MD, has also received training to use the Aurora EV-ICD system.

“This device not only provides lifesaving defibrillation (shock), but it also delivers anti-tachycardia pacing (ATP) therapy through a single, compact implant. Its design and functionality are comparable to traditional transvenous ICDs, yet it offers a safer and more efficient solution for our patients," Dr. Papireddy said.

"This technology is a significant addition to our cardiovascular toolkit, offering new hope and improved outcomes for patients who need it,” said Loveland Hobson, Ballad Health’s vice president of cardiology services. “The EV-ICD provides a safer and more efficient option, delivering critical therapy without the need for leads inside the heart and veins. We are proud to offer this advanced solution, further solidifying our commitment to exceptional cardiovascular care.”

The Medtronic EV ICD system recently was evaluated in a pivotal worldwide study, published in The New England Journal of Medicine, involving 356 patients at 46 hospitals in Europe, North America, the Middle East, Asia, Australia and New Zealand. In the study, the EV ICD System achieved a defibrillation success rate of 98.7% and met its safety endpoints of freedom from major system and/or procedural complications at six months after implant.

It's also the second advanced technology introduced at Holston Valley in 2024, following the hospital’s launch of the innovative FARAPULSE™ Pulsed Field Ablation System, which offers patients a unique alternative to caring for atrial fibrillation (AF), an irregular and often very rapid heart rhythm. Holston Valley was the fourth facility in Tennessee — the first in East Tennessee and among less than 150 facilities nationwide – to successfully perform cardiac ablation procedures using the FARAPULSE system, and it is now one of an elite group with the EV ICD System.

Holston Valley has received multiple accolades for its excellence in cardiac care, including Healthgrades’ 2025 Specialty Excellence Award for delivering superior clinical outcomes in vascular surgery. Additionally, Quantros named Holston Valley’s interventional carotid care in the top 10% of hospitals in the nation for medical excellence and in the top 100 hospitals in the nation for patient safety in its 2024 CareChex® awards. Quantros also rated the hospital’s major cardiac surgery and vascular surgery in the top 100 hospitals in the nation for patient safety, and ranked its cardiac care in the
top 10% in the nation for patient safety.

More information about the cardiac services, technology and clinicians offered by Ballad Health is available at www.balladhealth.org/heart.