Electrophysiologist Rick Henderson, MD, implanted one of the first wireless pacemakers in the country this week and while these initial devices to control abnormal heart rhythms are being reserved for certain patients, Henderson told Medical Device Daily that he expects to see the industry trend toward use of the advanced pacemakers for all patients.
"Our sentinel patient is a gentleman who required dual chamber pacing," said Henderson, who performed the procedure at Wake Forest University Baptist Medical Center's Heart Center (Winston-Salem, North Carolina). "He lives in a remote area of western North Carolina. The technology that St. Jude Medical (St. Paul, Minnesota) offered, this wireless capability, offers him daily access to a continuous monitor. No longer does he have to make the two-hour drive to have his device checked."
Henderson implanted the Accent RF pacemaker from St. Jude Medical, which was FDA approved just two months ago (Medical Device Daily, July 22, 2009). It features radio frequency (RF) telemetry that enables secure, wireless communication between the implanted device and the programmer used by the clinician or a home monitor.
The Accent RF transmits additional information about the patient's heart with greater frequency. Other features include AT/AF Alerts, AutoCapture Pacing System technology that measures the heart's reaction to pacing beat-by-beat and an algorithm that enables the heart's intrinsic rhythm to prevail when appropriate, thereby reducing unnecessary ventricular pacing. It reports 24 hours a day, even when the patient is asleep.
St. Jude Medical also just reported the European launch of the Merlin.net patient care network (PCN), a secure, Internet-based remote care system for patients with implanted medical devices, including the wireless pacemakers. Merlin.net PCN gathers and stores data from the implant procedure, in-clinic follow-up visits and from remote transmissions sent from a patient's home. Remote transmissions can include both patient-initiated and automatic follow-ups and monitoring transmissions sent via a Merlin@home remote transmitter (MDD, Sept. 9, 2009
Henderson said the pacemaker has appeal for use in patients who have underlying cardiovascular disease outside of their arrhythmias, particularly those at risk for developing atrial arrhythmia.
"We can pick up on atrial fibrillation whenever it occurs and then we can provide treatment – Coumadin – to prevent a stroke," he said, adding that the Accent RF delivers even more than standard pacemakers because it also relays device performance data, including events such as fractures in a lead and battery status.
All pacemakers do have some level of transtelephonic monitoring system that can send data over a telephone line if needed, but patients still must go to a clinic or hospital to have it periodically checked. The wireless model avoids those trips.
St. Jude Medical has three wireless pacemakers: a single-chamber version that goes into the right ventricle, a double-chamber version that goes into the right ventricle and atria, and a third version for heart failure patients that goes into the right ventricle, the left ventricle and the artery.
Henderson said the implantation, in a man in his mid-60s in relatively good health, went well.
"The procedure doesn't differ dramatically from other pacemaker implantations," he said. "One aspect this device has is the capability to communicate with it wirelessly during the implant. So, at the time of implant, we can assess what our parameters are. Also, the shape of the device impacts the pocket that I create. This device is a little rounder than other devices, so the pocket creation was easier."
This implantation was not part of a study. Henderson said that a St. Jude Medical sales representative was on hand and offered the device for use.
"It was just that we were one of the early ones with a patient who had a profile that married well," he said. "It's not going to be an exclusive implant for us. But geographic location, access to healthcare and cardiac comorbidities will impact and favor use of this device."
Lynn Yoffee, 770-361-4789;