Critical appraisal of cardiac implantable electronic devices: Complications and management

Abstract

Pacemakers, defibrillators and cardiac resynchronization devices (CIEDs) should not only meet regulatory requirements, but ideally also the expectations of medical staff and patients. Unfortunately, most of these clinical recommendations are fairly vague, and not related to specific products or malfunctions, but rather to some concept of overall performance. This may be entirely appropriate as the myriad of potential individual malfunctions can hardly be expected to be anticipated by medical staffs. This chapter will discuss some potential malfunctions, and how variable patient harms and complications may be for different malfunctions. The individual risks of patient harm considered together with their needs dictate recommendations for management of the malfunction.