Informed Consent in Cardiac Resynchronization Therapy

Abstract

Cardiac resynchronization therapy (CRT) for the treatment of heart failure (HF) raises complex problems for informed consent. CRT with and without defibrillator backup has been demonstrated in clinical trials to improve symptoms from HF and decrease mortality.1–4 A CRT pacemaker (CRT-P) may improve symptoms and reduce mortality in selected patients, even without offering the specific protection from malignant arrhythmias afforded by a CRT defibrillator (CRT-D). Further, CRT-P may prevent disease progression even in earlier stages of HF.4,5 Implantable cardioverter-defibrillators (ICDs) alone are effective in preventing sudden cardiac death (SCD) in selected patients.6,7 Although most patients eligible for CRT-P will similarly meet guidelines for an ICD, the decision to include ICD backup with a CRT implant may not be straightforward.8 The decision for CRT-P or CRT-D implantation includes not only the medical facts, but also the important considerations based on values and principles. Patients and physicians may wrestle with fundamental questions about quality and quantity of life and struggle to come together toward a truly informed consent process. There are no formal guidelines or standards that argue for specific content to be included in the informed consent process for CRT. This article examines 4 categories of questions regarding CRT based on an understanding of autonomy and shared decision-making as elements of informed consent: (1) control over the manner of death, (2) quality versus quantity of life, (3) therapeutic flexibility, and (4) clinical uncertainty. This article may help to guide clinicians and patients by clarifying the clinical and moral considerations and the principles behind particular treatment decisions. Autonomy refers to an understanding and knowledge of available options and the ability to choose between them through rational deliberation.9,10 Respect for patient autonomy is the foundation of modern bioethics and, in …