BRADENTON -- Since implanting his first subcutaneous defibrillator in a Manatee Memorial Hospital patient in late February, Dr. Joe Pace has seen his business pick up. So has the device's maker, Boston Scientific.
Pace, a partner at the Heart & Vascular Center of Bradenton and a staff physician at Manatee Memorial, has implanted four of the heart-regulating devices in a little over a month, and likely has a fifth surgery coming up. The spike in demand for the procedure comes courtesy of the fact that Manatee Memorial is the only hospital on Florida's west coast that is implanting the relatively new device.
A subcutaneous defibrillator uses an electrical shock to restart a heart that has stopped beating or has taken on an irregular beat. Defibrillators have long been implanted in the human body by routing shock-delivering wires, or leads, through a vein and into the heart. The subcutaneous device is routed just under the skin. It shocks the heart through the breastbone rather than from inside the heart.
The first of the Boston Scientific devices was implanted in a patient in late 2012. Since then, more than 2,000 have be implanted around the world.
For people in Manatee and
Sarasota counties suffering from heart arrhythmia or the possibility of sudden cardiac arrest, having a hospital and a surgeon that can install the minimally invasive device means fewer health complications and faster recovery. According to the company's website, a study of 330 patients receiving the defibrillator showed that the device performed without error 99 percent of the time over the course of a 180-day study period.
The new defibrillator is also less intimidating to patients, Pace said. They can resume normal activity immediately after surgery. In the past, weeks of healing were needed.
"It's opened up a new avenue of patients for the hospital," Pace said.
For area surgeons and hospitals, being an early adopter of the new technology brings more patients to the area. Pace is one of two Manatee Memorial surgeons trained to do the implantation procedure. He does up to 120 defibrillator implants and replacements each year.
Having the new defibrillator at the hospital has brought long-distance inquiries. The farthest came from a patient in Indiana.
Less invasive implantation
The Boston Scientific device is implanted just under the skin, away from blood vessels and organs. The electrical leads that shock the heart into a proper rhythm sit against the breast bone and have no direct contact with the heart. When the device picks up on a life-threatening heart event, it delivers a regulating electrical shock through the bone into the heart. A surgeon can install it by feel, no X-rays necessary. Its battery lasts up to five years.
Previous models of heart defibrillators and defibrillating pacemakers require surgeons to thread leads through a vein starting near the clavicle all the way into the heart. The procedure comes with risks, including the possibility that the leads can nick a lung or puncture heart muscle. Patients also get a dose of radiation because the progress of the lead through the vein must be monitored with repeated X-rays.
Implantable defibrillators manufactured by several companies have been plagued with recalls in recent years because of cracking in plastic insulation around electrical leads. The devices are subject to corrosion because they are in contact with blood and other bodily fluids, Pace said.
The country's largest defibrillator manufacturers are Boston Scientific, St. Jude Medical and Medtronic.
Cost of new device
Defibrillator implant surgeries generate a good deal of revenue for the hospital and doctors doing the procedure. Pace said the price to have the new device installed is equivalent to other pacemaker and implantable defibrillator install prices. A release of hospital pricing information from the federal government last year showed that Manatee Memorial charges $90,400 for such a procedure.
The new defibrillator has been or is expected to soon go into Manatee Memorial patients ranging in age from 27 to 74. One patient has already received three lifesaving electrical shocks from the device.
Pace said he thinks the new devices will last longer and suffer fewer failures. They're his choice when they are appropriate for use.
"If lead recalls are such a big issue, why would I want to put a lead inside a 27-year-old person who has 50 to 60 years to live?" he said.
The older style of defibrillator will still be needed for at least a third of the patients who need a device to monitor heart rhythm. Individual physiology can block the new device from detecting an irregular heart rhythm in some cases.
Pace implants the defibrillators at Manatee Memorial's catheterization lab. He said the hospital is an early adopter of the device because hospital management was "forward-minded" enough to make the technology available to its heart patients.
Paula Jefferson, a business developer in Manatee Memorial's cardiovascular division, said the hospital has a "good relationship" with Boston Scientific and was able to negotiate purchasing the new defibrillators before other area hospitals. She said new technology can be slow to get to some hospitals when they are part of larger purchasing networks.
Bradenton's other two hospitals, Lakewood Ranch Medical Center and Blake Medical Center, also do defibrillator implants. Lakewood Manatee Memorial and Lakewood Ranch Medical Center are part of the same company, but thus far Pace has done all his procedures with the new defibrillator at Manatee Memorial. Both hospitals have the catheterization labs needed to install defibrillators.
The Boston Scientific device is not yet available at Blake, according to hospital spokeswoman Melissa Morgan.
"We are always looking into new technologies and advancements in care for our patients," she said. "As part of that process, we are currently reviewing this exciting new technology."
Boston Scientific, which is headquartered in Natick, Mass., received FDA approval for the device in September 2012, according to Manatee Memorial Hospital. The company is expected to release a new version that is smaller and has a battery life of up to eight years.
Pace said he expects St. Jude and Medtronic to come out with their versions of the technology in coming years.
Matt M. Johnson, Herald business reporter, can be reached at 941-745-7027, or on Twitter @MattAtBradenton.