5/04/2001 - Receiving FDA approval for drugs, procedures and equipment is a routine experience for Vanderbilt University Medical Center physicians.
But for 9-year-old Meagan Boyter and her family, it is anything but normal.
Boyter was born with congenital AV Block, a condition that slows the heart rate. Patients require a pacemaker to stimulate the natural pacing of the heart. Although Meagan was born with an incomplete form of the disorder, her parents knew she would eventually rely on the implantable mechanical device to keep her hearts rhythms steady.
That day came.
Not only did she receive a device that would stimulate normal heart contractions, she also was the first in the region to receive the Integrity Micro DR Pacemaker made by Pacesetter, the smallest dual chamber pacemaker on the market to date.
But that notoriety wont last too long, cautioned Meagans physician Dr. Frank Fish, associate professor of Pediatrics and Medicine.
There is so much competition to produce the smallest device, Fish said. Meagans surgery happened to be the same day of the FDA release and we were able to implant the new one. This device is part of the progressive effort in the pacemaker industry to produce smaller and smaller pacemakers.
This device is simply one in an ongoing line of smaller ones to come, Fish said.
Until a few years ago, children with Meagans heart rhythm were typically given a single chamber pacemaker due to their size - but now the dual chamber pacemakers are smaller than recent single chamber devices, which allows for easier implantation in smaller patients.
Prior to having the pacemaker, Meagans heart rate averaged about 44 beats a minute with typical readings near 30. A normal resting heart rate for her age falls between 70-80 beats on average. While an active heart typically achieves rates up to 200 beats, Meagans heart reached 82 beats.
She was so tired, said Peggy Boyter, Meagans mother. I can not tell you the difference the pacemaker has made. Its amazing. Her energy level continues to go up, up, up. She used to be sleepy all the time and was very irritable. But now, its full steam ahead.
They told us that she was the first person to get this new pacemaker in Middle Tennessee. We have just been amazed because you can really tell a difference. In just two weeks time, the difference was remarkable.
Fish said prior to using pacemakers to treat this condition patients had no alternatives. Although patients could live with slow heart rates, they would have to endure enormous fatigue. Patients with dangerously slow heart rates due to heart block are more susceptible to cardiac arrests.
But thanks to this device Meagan, a third-grader at Spring Hill Elementary, is on the mend.
She will visit Fish twice a year. Between visits, she uses a home monitoring system monthly so that Fish can evaluate her heart. Bands are placed around Meagans arms and the telephone is attached to a machine, which transmits Meagans heart rate readings to Fish. This allows him to detect any problems. Twice yearly, the device is checked in clinic and any necessary adjustments can be programmed.
He projects she will need a new device in about 10-12 years.
With increasing interest in creating smaller, slimmer devices, Meagans next pacemaker most likely will be even smaller, yet offer more advanced features.©2016 Vanderbilt University Medical Center