for ICD/CRT Implantation in Pediatric and Congenital Heart Patients: What You Need to Know The author provides an overview of the recently revised guidelines presented by the Heart Rhythm Society and the Pediatric and Congenital Electrophysiology Society (PACES). An increasing number of ICD/CRT-D implants are being performed in the pediatric and congenital heart disease patient groups. No prospective clinical trials of safety and efficacy have ever been conducted within these device populations. However, the advances in technology that have occurred in recent years have made these therapies available to these groups. Work of the Task Force At Heart Rhythm 2008, the Heart Rhythm Society/PACES Clinical Competency Statement: Training pathways for implantation of cardioverter-defibrillators and cardiac resynchronization therapy devices in pediatric and congenital heart patients1 was released. These guidelines were developed by a group of adult and pediatric cardiologists and surgeons. Their task involved assessing the frequency of device implantation in pediatric and congenital heart populations in U.S., Canadian, European and South American hospitals. They compared this actual experience to the recommendations that have previously existed for training and competency of device implantation for practitioners of adult cardiology [Adult Cardiovascular Medicine Core Cardiology Training (COCATS)]. 2 They also compared this experience to prior recommendations for training in pediatric cardiology (Task Force 4: Recommendations for Training Guidelines in Pediatric Cardiac Electrophysiology).3 The 2004 adult ICD/CRT clinical competency statement recommendations are seen in Table 1 and include a two-track system: one for electrophysiologists and one for non-electrophysiology implanters. Prior pediatric recommendations also included a two-track system: one for electrophysiologists who prescribed and followed pacemaker patients, and one for implanters who also followed patients. The guidelines recommended that those in both tracks be active in the evaluation and follow-up of 75 device patients; track one should be in attendance at intra-operative testing of 35 device implants, while track two should participate directly in 50 implants. The results of the survey of actual practice and implantation conducted by the task force revealed that at least half of the training centers surveyed were performing fewer device implants per year than the recommended guidelines for one individual trainee. As a result of these findings, the need to revise the guidelines was recognized. In addition, alternative pathways for insuring adequate training opportunities were recommended. The following is a summary of the new task force recommendations. The Universal Criteria for Implantation in Pediatric and Congenital Heart Patients The revised recommendations for training and practice include general guidelines for all who are involved with implants as well as some specific criteria for individual implanter/follow-up groups. The general physician guidelines include NASPExAM/IBHRE or CCEP certification. Institutional criteria includes having the faculty and staff appropriate for the patient population; in addition, there should be an organized program for device tracking, tracking outcomes, tracking complications, and follow-up. The institution must also have available pediatric and congenital interventional catheterization and cardiac surgical expertise for those with complex congenital heart disease or those ≤ 12 years. Criteria in addition to the universal criteria are outlined per specialty as follows: Physicians in training: 25 primary implants/revisions/replacements, the majority of these in patients ≤ 12 years or with congenital heart disease. These implants may be accrued over multiple years and within adult EP training programs. Fifty follow-up visits are required. Physicians currently implanting with prior EP training: 1) must be board certified or eligible for subboard in pediatric cardiology; 2) have completed a minimum of one year of pediatric EP fellowship or ≥ 5 years of practice in pediatric EP with device experience; and 3) maintain a practice of 10 implants/revisions/replacements per year and 20 follow-up visits. Alternative pathway for low patient volume: in addition to the board and practice requirements listed above for current implanters, there must be documented association with adult EPs who have adult ICD/CRT/CRT-D competencies, CCEP certification, credentials to practice in the pediatric laboratory, and are available for consultation and emergency assistance during all procedures. Adult electrophysiologists: must be competent for adult device implantation; for patients ≤ 12 years, they must have prior implant experience with a minimum of 10 patients and have documented prior consultation with or direct referral from a pediatric cardiologist. For patients with complex congenital heart disease, the implanter must have significant experience with such implants and have documented prior consultation with or direct referral from a specialist in pediatric or adult congenital cardiology. In addition, a pediatric or adult congenital cardiologist must be available for consultation during the procedure. Appropriate follow-up must be assured. Non-electrophysiologists: implants must be performed in collaboration with a trained electrophysiologist who meets competency for pediatric and congenital patients or a trained pediatric electrophysiologist who meets the criteria for evaluation and follow-up of pediatric and congenital device patients but does not meet implant criteria. Device follow-up must also be assured. Summary These guideline revisions resulted from a discovered disconnect between practice expectations and reality. The revised timelines for achievement of implant competency along with the recommended enhanced affiliation with adult implanters provides a more realistic guideline for implant practice. This ongoing practice analysis helps to ensure that pediatric implanters will receive the training and ongoing experience needed to provide safe and effective care to the pediatric and congenital heart populations.