University of Minnesota Health Heart Care cardiologists have successfully implanted a promising and innovative leadless pacemaker into three patients as part of a cutting edge clinical trial at Fairview Southdale Hospital.
Traditional pacemakers are implanted under the skin of the chest to electrically stimulate the heart via leads connected to the heart muscle. The leads, which are threaded through blood vessels to the heart, are the most vulnerable part of the traditional pacing systems and occasionally need to be replaced, according to University of Minnesota Health Heart Care Cardiologist Demosthenes Iskos, MD. Iskos and Cardiologist Quan Pham, MD, FACC, are the co-investigators leading this clinical trial.
Replacement of those leads can be problematic, Iskos said, because the wires can obstruct blood vessels or scar into the blood vessel walls, making removal difficult. Conventional pacemakers also require a surgical incision in the chest so that a doctor can implant the pacemaker in a pocket under the skin.
The new leadless pacemaker, developed by St. Jude Medical, is placed directly into the heart wall using non-invasive surgical techniques, eliminating the need for leads, Iskos said. A health care team positions the device using a catheter run through the femoral vein in the groin to the patient’s heart. The procedure takes about 45 minutes and does not require any incisions. The device itself is roughly 10 percent of the size of a traditional pacemaker.
No other sites in the Twin Cities are currently offering the St. Jude Medical Nanostim™ leadless pacemaker through a clinical trial, Iskos said.
At the moment, leadless pacemakers can only be used in a select group of patients with atrial fibrillation that meet certain medical criteria. But Iskos believes the new pacemaker design will have far-reaching applications in future medical use.
“This is an exciting first look into the future,” said Iskos. “20 years from now, I believe the typical pacemaker will be a very small, high-tech leadless device capable of performing better than current pacemakers. The device will leave no chest scars, will have no leads to worry about and will have excellent reliability.”