Michael Rinaldi, MD

They say that time heals all wounds. Often it’s the medical innovations that come with that time that make the biggest differences. No one knows that better than Michael Rinaldi, MD, interventional cardiologist and medical director of clinical research at Sanger Heart & Vascular Institute. He, along with John Holshouser, MD, has been witness to an exciting new advancement.

In March 2015, the FDA approved the WATCHMAN DeviceTM, which helps patients who are at risk of developing blood clots as a result of atrial fibrillation (Afib) and who are not acceptable candidates for oral anticoagulation. Patients with Afib are at a greater risk for a number of diseases, including heart failure, dementia and stroke. With stroke especially, the best treatment is prevention. Part of that prevention has been a warfarin regimen (blood thinner medication taken orally) to help prevent blood clots. Unfortunately, some patients on such a regimen suffer uncontrolled bleeding as a result of the medication. In fact, up to a third of patients at risk of stroke are not acceptable candidates for oral anticoagulation due to this bleeding risk.

“Most blood clots that form during Afib occur in the left atrial appendage (LAA) – a pouch that serves no useful purpose,” said Dr. Rinaldi. “We’ve known that this has been an issue for 90 to 95 percent of our Afib patients, and until now there was nothing we could do about it.”     

Medical and mechanical advancements have come together in the new WATCHMAN Device, intended for percutaneous, transcatheter closure of the left atrial appendage. With the patient under general anesthesia, the device is implanted into the heart through a vein in the leg.   

For non-valvular Afib patients, the WATCHMAN Device may be an alternative to warfarin therapy. In trial for five years, the device has been found to be as effective as warfarin, and had a bit of an advantage when it came to mortality rates. As the WATCHMAN Device does not require long-term oral coagulation, long-term bleeding risks are markedly lower.      

“This new mechanical alternative is wonderful for those patients who had no other options before,” said Dr. Rinaldi. “Sanger Heart and Vascular Institute was one of only two facilities in the Carolinas to be involved in the trial and we’ve had great results. We are now the only center in the region offering this device.”

Dr. Rinaldi is the most tenured, most experienced, highest volume implanter in the Carolinas and Tennesee. The first post-FDA approval implant was scheduled for late June at Sanger Heart & Vascular Institute, and the excitement is high. “We’re really thrilled about what this means for our patients,” he said.