See the device instructions for
use for detailed information regarding the procedural instructions, indications, contraindications, warnings, precautions, and potential complications/adverse events.
See www.manuals.medtronic.com for complete labeling.
Benefit for NYHA class I and II patients has only been shown in CRT-D trials, and while patients may not experience immediate symptomatic benefit, late remodeling may be avoided along with long-term HF consequences. There are no trials that support CRT pacing (without ICD) in NYHA class I and II patients. Thus, it is anticipated these patients would receive CRT-D unless clinical reasons or personal wishes make CRT pacing more appropriate. In patients who are NYHA class III and ambulatory class IV, CRT-D may be chosen but clinical reasons and personal wishes may make CRT pacing appropriate to improve symptoms and quality of life when an ICD is not expected to produce meaningful benefit in survival.
*On stable, optimal heart failure medical therapy if indicated.
†NYHA Class IV patients should be ambulatory with no admissions for HF in the last month and have a reasonable expectation of survival.
**LBBB = Left bundle branch block.
††Atrioventricular block (AV block) expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing.
***Established before implant if indicated, and should be done post-implant.
†††There is no Medicare National Coverage Decision for CRT devices. Only one Medicare Administrative Contractor (MAC) — First Coast Service Options, Inc. responsible for Florida, Puerto Rico, and Virgin Islands — has a policy according to which NYHA class I patients with AV block are not covered. In the absence of a MAC local policy determination, coverage for CRT devices are generally available for all labeled indications. This information is subject to change and the provider has the responsibility to determine medical necessity and to submit appropriate codes and charges for care provided.
These considerations are provided for general educational purposes only and should not be the exclusive source for this type of information. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.
Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. October 15, 2015;62(16):e147-e239.
Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. January 20, 2005;352(3):225-237.
Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. March 21, 2002;346(12):877-883.
Bristow MR, Saxon LA, Boehmer J, et al. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. May 20, 2004;350(21):2140-2150.
Cleland JG, Abraham WT, Linde C, et al. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure. Eur Heart J. December 2013;34(46):3547-3556.
Linde C, Abraham WT, Gold MR, et al. Predictors of short-term clinical response to cardiac resynchronization therapy. Eur J Heart Fail. August 2017;19(8):1056-1063.
Sweeney MO, Hellkamp AS, Ellenbogen KA, et al. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. June 17, 2003;107(23):2932-2937.
Curtis AB, Worley SJ, Adamson PB, et al. Biventricular pacing for atrioventricular block and systolic dysfunction. N Engl J Med. April 25, 2013;368(17):1585-1593.