Heart Rhythm Society Clinical Competency Statement for ICD/CRT Implantation

In a letter to Heart Rhythm Society members, the board stated the new guidelines were not developed at the request of industry—they were developed both to meet an anticipated growth in the implantation of ICDs and to prevent non-electrophysiologists from being certified to perform these procedures by attending a weekend course.¹ A review of the new guidelines follows.

Why is there a need to issue guidelines?

Clinical trial results of the last five years have shown that heart failure patients benefit from prophylactic ICD implantation to prevent sudden cardiac death, and resynchronization therapy (CRT) to improve cardiac contractility and improve quality of life. Physicians who care for heart failure patients require the knowledge and expertise to identify appropriate candidates for device therapies, to implant these devices safely and to deal with complications and follow-up appropriately. Fellowship in a cardiac electrophysiology program helps to guarantee these skills. The non-electrophysiologist, however, may see many patients who qualify for such therapies and have an interest in implanting such devices. Thus, the Heart Rhythm Society saw a need to develop guidelines to ensure that patient safety would be upheld by offering a training and experience model to guide potential implanting physicians and hospitals. These training guidelines apply to cardiologists (non-electrophysiologists) who are already device implanters. These guidelines were approved by the HRS Board of Trustees on May 18, 2004. Physicians who are already in a cardiovascular training program are governed by the COCATS guidelines for training in adult cardiology; thus, this document does not change their training qualifications.

Training Tract for ICD and CRT Implantation for Non-Electrophysiologists

Experienced physician device implanters who have not undergone formal training in clinical cardiac electrophysiology are the group to whom this document is primarily directed. These physicians would require added technical skills plus formal didactic education in ICD and CRT implantation to ensure patient safety and optimal outcomes. These guidelines do not apply to those who have no device implant experience.

Who is Considered an Experienced Implanter?

An experienced implanter is defined by HRS as one who implants >= 35 pacemakers per year and a minimum of 100 implants for the past three years. It is believed that such implanters will be more likely to use the advanced programming features of devices and therefore also require less outside technical support. Because CRT systems are inherently more complex than standard pacemakers, it is thought that the experienced implanter would be more capable of managing such systems. The experienced implanter candidate must also have a developed program of patient follow-up.

Training for ICD Implantation for the Experienced Implanter

Patients who have ventricular tachycardias or history of ventricular fibrillation are not the patients for whom ICDs implanted by this group is recommended. These patients and their ICDs are best cared for by experienced electrophysiologists. The patient population for the experienced implanters is those who are at high risk but have not yet had an event. Moreover, after an event has occurred, these patients should be transferred to the care of an electrophysiologist. The proctor must have graduated from a certified ACGME training program in electrophysiology or device implantation, be out of training for at least two years, must be implanting at least 25 ICDs a year and be following at least 50 ICD patients per year.

CRT Implantation

Experienced pacemaker implanters who wish to implant left ventricular leads for resynchronization therapy must observe at least two procedures and perform at least five coronary sinus lead placements with a proctor. A proctored resynchronization ICD implant would count toward both an ICD and a CRT device. Again, the training guidelines for this skill is outlined in Table 1.

Patient Follow-up

The experienced implanter who follows ICD patients should only program the bradycardia and defibrillation parameters of the device. ATP, because it is used to terminate a known tachycardia, should only be programmed by an experienced electrophysiologist who would then also be involved in follow-up care. The guidelines recommend that the experienced implanter also have an established back-up electrophysiologist to assume care of the patient who requires more complex follow-up or whose condition worsens. Should a patient s defibrillator actually discharge, that patient would then be referred to an electrophysiologist for any further follow-ups. CRT patients who worsen should also be referred to electrophysiology and heart failure services.

Training Documentation and Maintenance of Competence

The following materials would be submitted to the hospital credentialing committee prior to unsupervised implants: proof of current experience and privileges within the institution, a CME certificate from an approved training course, documentation of experience from a proctor, documentation of a plan for patient follow-up and a letter from an electrophysiologist who will be a back-up. The recommendations for maintenance of competence include performing a minimum of 10 ICDs procedures and 10 CRT devices procedures per year. Falling below this number would require a proctored retraining for five implants. A minimum of 20 patients should be followed per year for competency in programming and follow-up. Two hours of CME per year in devices is the minimum didactic requirement.

Conclusion

The new guidelines are thought to be the first step toward a credentialing system in implantation. The end result is hoped to be increased safety for our patients and improved care outcomes, which is what we are really all about.