Establishing and Managing a Device Clinic and Database

Clinics for the Follow-Up of Cardiovascular Implantable Electronic Devices

The story of cardiovascular implantable electronic devices (CIEDs) started in 1958 with the first pacemaker (PM) implant performed at Karolinska Hospital in Stockolm and evolved with the first implant of an implantable cardioverter-defibrillator (ICD) performed in Baltimore in 1980. Over time the possibilities to benefit patients with arrhythmia disturbances has evolved, and therapy with an electrical device nowadays includes also selected patients with heart failure.

The follow-up of CIEDs is a crucial component of effective and safe delivery of device therapy and must include therapy optimization and individualization, when needed. Currently, in a clinic targeted to follow current CIEDs, the type of devices to check includes PMs, ICDs, devices for cardiac resynchronization therapy (CRT), implantable loop recorders (ILRs), and implantable cardiovascular monitors (ICMs).

A CIED service or CIED follow-up clinic is a center that provides specialized care and training in cardiac pacing and defibrillation with two or more physicians who are specialists in device implantation and management, nurses and/or technical personnel (at least one allied professional with experience in implantable device management), dedicated equipment, including pacing system analyzers, programmers from multiple manufacturers, and access to remote monitoring platforms (on dedicated computers), and computer systems for storage of data. A functional connection to services related to imaging (x-ray, echocardiography and nuclear cardiology) should be available. Moreover, functional connection to heart failure follow-up services must be available, for appropriate decision making in patients with a CIED and specifically a CRT device. Obviously, full resuscitation facilities should be immediately available in the area of the CIED clinic, with an external defibrillator with integrated pacing function.

In the CIED clinic the experience derived from an appropriate volume of cases, related to all types of devices (PMs, ICDs, CRT devices), is required.

Increased Cardiovascular Implantable Electronic Device Follow-Up Volume

The number of CIEDs is increasing worldwide. The Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA) Expert Consensus on the Monitoring of CIEDs reported for the year 2006 an estimate of approximately 280,000 PMs and 160,000 ICDs implanted in North America, and of 250,000 PMs and 50,000 ICDs in western and central Europe. Substantial heterogeneity across Europe exists and implant rates for ICDs and CRT devices are still low in Eastern Europe. The worldwide cardiac pacing and ICD survey undertaken for the calendar year 2009 accounted for 1,002,664 PMs, with 737,840 new implants and 264,824 replacements, and 328,027 ICDs, with 222,407 new implants and 105,620 replacements.

According to these numbers, it is clear that follow-up and monitoring CIEDs is associated with an increasing burden of care for specialized centers with a CIED clinic.

Goal of Cardiovascular Implantable Electronic Device Follow-Up

As detailed in the HRS/EHRA Expert Consensus on the Monitoring of CIEDs, the goals of CIED follow-up can be broken into four categories: (1) patient, (2) device, (3) disease, and (4) communication, as delineated in Box 43-1 .

Even if the categories and goals of CIED follow-up did not change, the HRS Expert Consensus Statement on Remote Interrogation and Monitoring for Cardiovascular Electronic Implantable Devices released in 2015 substantially magnified the incorporation of remote monitoring into follow-up practice, integrating the option of remote trans­mission of CIED data with in-office device checks, with a modified frequency. This change is supported by a series of randomized controlled trials that have compared conventional in-person checks versus remote management strategies for the follow-up care of patients with CIEDs, with the results of improved adherence to scheduled evaluations when remote monitoring is adopted.