SAN FRANCISCO — Presenters at this week's Scientific Sessions of the Heart Rhythm Society (HRS; Chicago) identified what might be loosely considered an "orphan" device opportunity.
And while they said there is little likelihood that this opportunity will be pursued by device manufacturers, they emphasized the need to address what essentially is its absence — on the training side.
Rolling out a new guidance, presenters addressed the increased use of electronic implanted cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices in children with heart disease, and in people with congenital heart disease, but requiring devices designed for adults.
HRS, in collaboration with the Pediatric and Congenital Electrophysiology Society (PACES), formed a task force to deliver guidance in these areas — the resultant document having the interminably lengthy title, "Heart Rhythm Society/PACES Clinical Competency Statement: Training pathways for implantation of cardioverter-defibrillators and cardiac resynchronization therapy devices in pediatric and congenital heart patients."
Presenters said it was needed for two reasons: the relatively small number of these implants being done, but the varied specialties involved in doing them.
An additional issue is the lack of such devices designed specifically for these populations.
Like the HRS guidance rolled out Wednesday at the meeting concerning the need for better post-implant management of patients with implanted electronic devices (Medical Device Daily, May 16, 2008), the absence of a previous guidance on this issue indicated a major gap.
HRS said that the guidance is the first "to offer competency criteria and training pathways for a variety of specialties, such as pediatric and adult electrophysiology, pediatric and adult cardiology, as well as pediatric and adult cardiac surgery."
Richard Friedman, MD, of Texas Children's Hospital (Houston) and incoming president of PACES, termed the pediatric and congenital heart patients targeted by the document as "a very specialized population," including about one million adults in the U.S. needing continuing care as they age, and often developing difficult arrhythmias.
And pediatric heart patients, he said, need a more targeted approach because they "have complex anatomy, they are smaller, more active [and put] significant stress on these devices after they are implanted."
He estimated from 600 to 1,000 device implantations in this group yearly in the U.S., with a somewhat lower number in Europe.
J. Philip Saul, MD, of the Medical University of South Carolina (Charleston), noted that there had been no "adequate" database for these implants and where they are done, and so developing this was the task force's first task.
He said the group found 49 programs worldwide implanting devices in this population but only 11 of them offering the relevant training, and with smaller centers doing an average of only about eight implants of this type each year.
With "such low volume," he said, "you have a hard time training an individual."
Needed, he said, are "multiple years of training, extending beyond the initial formal training period."
Thus, HRS said the new guidelines are the first "that allow physicians to acquire the recommended number of procedures through either the use of additional years after formal training, or through participation in cases with an adult program."
The guidelines provide what it terms "Universal Criteria" requiring physicians to have certification, as well as, for each institution, the following:
• facility and staff appropriate for the patient population;
• an "organized" program for device tracking and follow-up;
• an "organized" program for tracking outcomes/complications;
• and pediatric and congenital interventional catheterization and cardiac surgical expertise at institutions that serve patients under 12-years-old, or patients with complex congenital heart disease.
Friedman and Saul agreed that the limited population being addressed probably works against manufacturers developing implanted electronic devices for these populations but that "indirectly, industry is trying to do that," in particular through the development of devices for smaller adult frames and the development of thinner and sometimes shorter leads.
"This is a help on both sides of the fence — it's helpful on the adult side for those who are smaller, easier to implant." And, he added: "There are some special things that we would like and we have pushed the companies."
— DON LONG, Executive Editor