Use of Cardiac Resynchronization Therapy in the Medicare Population

CMS evidence review | evidence_type=Technology Assessment | record_type=technology_assessment | document_id=100 | year=2015

Chronic heart failure (CHF) is a major public health problem in the United States affecting an estimated 4.9 million Americans, causing high rates of hospitalization, poor quality of life, and 300,000 deaths each year. Cardiac resynchronization (CRT) is a pacing modality utilizing a left ventricular (LV) pacing lead with the goal of re-synchronizing myocardial contraction in patients with CHF. CRT was originally indicated in patients with significant LV dysfunction, defined as a left ventricular ejection fraction (LVEF) ≤ 35%, New York Heart Association (NYHA) class III-IV heart failure symptoms, and a QRS duration ≥ 120ms on optimal medical therapy. More recently, the indications for CRT expanded to include patients with minimally symptomatic heart failure (NYHA class II). The appropriateness of CRT in patients with NYHA class I symptoms is unclear. The vast majority of candidates for CRT devices also have an indication for an implantable cardiac defibrillator (ICD), therefore, the large majority of patients receiving CRT in the United States receive a CRT device with a defibrillator (CRT-D) as opposed to a CRT pacemaker (CRT-P). CRT-P devices are occasionally placed in patients who wish to avoid ICD shocks or in patients with an indication for frequent ventricular pacing due to conduction disease who have an LVEF between 36-50 percent.

Issue: Chronic heart failure (CHF) is a major public health problem in the United States affecting an estimated 4.9 million Americans, causing high rates of hospitalization, poor quality of life, and 300,000 deaths each year. Cardiac resynchronization (CRT) is a pacing modality utilizing a left ventricular (LV) pacing lead with the goal of re-synchronizing myocardial contraction in patients with CHF. CRT was originally indicated in patients with significant LV dysfunction, defined as a left ventricular ejection fraction (LVEF) ≤ 35%, New York Heart Association (NYHA) class III-IV heart failure symptoms, and a QRS duration ≥ 120ms on optimal medical therapy. More recently, the indications for CRT expanded to include patients with minimally symptomatic heart failure (NYHA class II). The appropriateness of CRT in patients with NYHA class I symptoms is unclear. The vast majority of candidates for CRT devices also have an indication for an implantable cardiac defibrillator (ICD), therefore, the large majority of patients receiving CRT in the United States receive a CRT device with a defibrillator (CRT-D) as opposed to a CRT pacemaker (CRT-P). CRT-P devices are occasionally placed in patients who wish to avoid ICD shocks or in patients with an indication for frequent ventricular pacing due to conduction disease who have an LVEF between 36-50 percent. Other Material: Other Material 1 Questions: Questions Technology Assessment: Download Technology Assessment [PDF, 1.57MB] Download Appendices [PDF, 2.52MB]