Download TABLE OF CONTENTS

Survey
yes no Was this document useful for you?
   Thank you for your participation!

* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project

Document related concepts

Baker Heart and Diabetes Institute wikipedia , lookup

Remote ischemic conditioning wikipedia , lookup

Management of acute coronary syndrome wikipedia , lookup

Coronary artery disease wikipedia , lookup

Cardiothoracic surgery wikipedia , lookup

Rheumatic fever wikipedia , lookup

Lutembacher's syndrome wikipedia , lookup

Mitral insufficiency wikipedia , lookup

Jatene procedure wikipedia , lookup

Hypertrophic cardiomyopathy wikipedia , lookup

Quantium Medical Cardiac Output wikipedia , lookup

Cardiac surgery wikipedia , lookup

Electrocardiography wikipedia , lookup

Heart failure wikipedia , lookup

Cardiac contractility modulation wikipedia , lookup

Myocardial infarction wikipedia , lookup

Ventricular fibrillation wikipedia , lookup

Heart arrhythmia wikipedia , lookup

Arrhythmogenic right ventricular dysplasia wikipedia , lookup

Transcript
Cardiac Resynchronization Therapy (Biventricular Pacing)
Last Review Date: March 10, 2017
Number: MG.MM.SU.41eC
Medical Guideline Disclaimer
Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the patient
meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the
request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically
necessary. EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in
the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies,
evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other
relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information.
Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a
representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that
EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In
addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for
Medicare and Medicaid members. All coding and web site links are accurate at time of publication. EmblemHealth Services Company LLC, (“EmblemHealth”) has
adopted the herein policy in providing management, administrative and other services to HIP Health Plan of New York, HIP Insurance Company of New York, Group
Health Incorporated and GHI HMO Select, related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under
common control of EmblemHealth Inc.
Definitions
Cardiac pacing modalities
Treatment modalities that utilize biventricular or left ventricular stimulation to optimize
cardiac pump function through synchronization of ventricular contraction are referred
to as resynchronization or ventricular resynchronization therapies. The rationale for
resynchronization is based on the clinical observation that congestive heart failure
(CHF) patients with intraventricular conduction defects (IVCD) have mechanical
desynchronization between the left and right ventricles throughout the cardiac cycle,
which adversely affects left ventricular performance.
Biventricular pacing simultaneously activates the left and right ventricles using a
combination of conventional, dual-chamber pacing of the right atrium and ventricle and
specialized pacing of the left ventricle through leads positioned via the coronary sinus.
Ejection fraction (EF) or Left ventricular
ejection fraction (LVEF)
Percentage of blood ejected from the left ventricle with each heartbeat. Normal LVEF
readings are in the 58-70% range.
QRS complex
Refers to a portion of a tracing within an electrocardiogram that represents the spread
of the electrical impulse through the ventricles. A prolonged QRS interval indicates a
dyssynchrony of the right and left ventricle and is an important selection criterion for a
biventricular pacemaker.
Ventricular tachyarrhythmias
Rapid heartbeat that may be regular or irregular arising from the ventricle or pumping
chamber of the heart. Two common tachyarrhythmias are ventricular tachycardia and
ventricular fibrillation.
Ventricular fibrillation (Vfib or VF)
Condition in which the heart's electrical activity becomes disordered. When this
happens, the heart's lower (pumping) chambers contract in a rapid, unsynchronized
fashion (the ventricles "quiver" rather than beat) and the heart pumps little or no
blood.
Ventricular tachycardia (Vtach or VT)
Fast regular heart rate that starts in the lower chambers (ventricles). VT may result
from serious heart disease and usually requires prompt treatment.
American College of Cardiology Foundation
(ACCF)/American Heart Association (AHA)
Stages of Heart Failure (HF)
A:
B:
C:
D:
At high risk for HF but without structural heart disease or symptoms of HF
Structural heart disease but without signs
Structural heart disease with prior or current symptoms of HF
Refractory HF requiring specialized interventions
Resynchronization Therapy For Congestive Heart Failure
Last Review: March 10, 2017
Page 2 of 4
New York Heart Association (NYHA) Functional Classification System
Class
Patient Symptoms
Class I (Mild)
No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness
of breath).
Class II (Mild)
Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or
dyspnea.
Class III
(Moderate)
Marked limitation of physical activity. Comfortable at rest, but less-than-ordinary activity causes fatigue, palpitation, or
dyspnea.
Class IV (Severe)
Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity
is undertaken, discomfort is increased.
Guideline
Cardiac resynchronization therapy (CRT) using an FDA-approved biventricular pacemaker is considered medically
necessary for members with moderate to severe symptomatic CHF (NYHA functional class II, III or ambulatory Class IV)
with IVCD when the following criteria are met; all:
1. Presence of persistent symptoms despite guideline-directed medical therapy (GDMT) therapy; i.e.::

Angiotensin-converting enzyme (ACE) inhibitors

Angiotensin receptor blockers

Beta blockers
2. Left ventricular ejection fraction (LVEF) ≤ 35%
3. Presence of either:

QRS ≥ 120–190 milliseconds (ms) and left bundle branch morphology

QRS ≥ 150 ms and any QRS morphology
4. Sinus rhythm (or alternatively) when ablation of AV node or pharmacologic management of atrial fibrillation
rate allows near 100% ventricular pacing)
Note: EmblemHealth considers the use of a FDA-approved implantable cardioverter defibrillator (ICD) device, combined
with cardiac resynchronization therapy (i.e., CRT/ICD), to be medically necessary when the plan’s ICD Medical Guideline
criteria are met in addition to the CRT criteria above.
Limitations/Exclusions
Upgrades from a standard single-lead right ventricular device to resynchronization device (i.e., biventricular pacing
achieved by adding left ventricular lead) is allowable for members who have heart failure (LVEF <35%) with symptomatic
bradycardia (or heart block) who are pacing > 50% of the time with their current pacemaker.
Biventricular pacemaker devices (as well as combined biventricular pacemaker-defibrillator devices [CRT/ICD]) are
considered investigational and not medically necessary for any indication other than those listed above due to
insufficient evidence of therapeutic value.
Resynchronization Therapy For Congestive Heart Failure
Last Review: March 10, 2017
Page 3 of 4
Applicable Procedure Codes
33206
Insertion or replacement of permanent pacemaker with transvenous electrode(s); atrial
33207
Insertion or replacement of permanent pacemaker with transvenous electrode(s); ventricular
33208
Insertion or replacement of permanent pacemaker with transvenous electrode(s); atrial and ventricular
33212
Insertion or replacement of pacemaker pulse generator only; single chamber, atrial or ventricular
33213
Insertion or replacement of pacemaker pulse generator only; dual chamber
33214
Upgrade of implanted pacemaker system, conversion of single chamber system to dual chamber system (includes removal of
previously placed pulse generator, testing of existing lead, insertion of new lead, insertion of new pulse generator)
33215
Repositioning of previously implanted transvenous pacemaker or pacing cardioverter-defibrillator (right atrial or right ventricular)
electrode
33216
Insertion of a single transvenous electrode, permanent pacemaker or cardioverter-defibrillator
33217
Insertion of 2 transvenous electrodes, permanent pacemaker or cardioverter-defibrillator
33224
Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, with attachment to previously placed pacemaker or
pacing cardioverter-defibrillator pulse generator (including revision of pocket, removal, insertion, and/or replacement of generator)
33225
Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of pacing cardioverter-defibrillator
or pacemaker pulse generator (including upgrade to dual chamber system) (List separately in addition to code for primary procedure)
33226
Repositioning of previously implanted cardiac venous system (left ventricular) electrode (including removal, insertion and/or
replacement of generator)
33240
Insertion of single or dual chamber pacing cardioverter-defibrillator pulse generator
33241
Subcutaneous removal of single or dual chamber pacing cardioverter-defibrillator pulse generator
33243
Removal of single or dual chamber pacing cardioverter-defibrillator electrode(s); by thoracotomy
33244
Removal of single or dual chamber pacing cardioverter-defibrillator electrode(s); by transvenous extraction
33249
Insertion or repositioning of electrode lead(s) for single or dual chamber pacing cardioverter-defibrillator and insertion of pulse
generator
Applicable ICD-10 Diagnosis Codes
I09.81
Rheumatic heart failure
I42.1
Obstructive hypertrophic cardiomyopathy
I44.1
Atrioventricular block, second degree
I44.2
I44.30
Atrioventricular block, complete
Unspecified atrioventricular block
I44.39
Other atrioventricular block
I44.4
Left anterior fascicular block
I44.5
Left posterior fascicular block
I44.60
Unspecified fascicular block
I44.69
Other fascicular block
I44.7
Left bundle-branch block, unspecified
I45.0
Right fascicular block
I45.10
Unspecified right bundle-branch block
I45.19
Other right bundle-branch block
I45.2
Bifascicular block
I45.3
Trifascicular block
Resynchronization Therapy For Congestive Heart Failure
Last Review: March 10, 2017
Page 4 of 4
I45.4
Nonspecific intraventricular block
I45.5
Other specified heart block
I49.5
I50.1
Sick sinus syndrome
Left ventricular failure
I50.20
Unspecified systolic (congestive) heart failure
I50.21
Acute systolic (congestive) heart failure
I50.22
Chronic systolic (congestive) heart failure
I50.23
Acute on chronic systolic (congestive) heart failure
I50.30
Unspecified diastolic (congestive) heart failure
I50.31
Acute diastolic (congestive) heart failure
I50.32
Chronic diastolic (congestive) heart failure
I50.33
Acute on chronic diastolic (congestive) heart failure
I50.40
Unspecified combined systolic (congestive) and diastolic (congestive) heart failure
I50.41
Acute combined systolic (congestive) and diastolic (congestive) heart failure
I50.42
Chronic combined systolic (congestive) and diastolic (congestive) heart failure
I50.43
Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure
I50.9
Heart failure, unspecified
Q24.6
Congenital heart block
References
Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002; 346:1845.
American College of Cardiology/American Heart Association Task Force on Practice Guidelines. ACC/AHA/HRS Focused Update of the 2008
Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities. 2012. http://content.onlinejacc.org/article.aspx?articleid=1357576.
Accessed March 15, 2016.
Cleland JG, Daubert JC, Erdmann E, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med
2005; 352:1539.
Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a
report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise
the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): developed in
collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation 2008; 117:e350.
Gerber TC, Nishimura RA, Holmes DR, et al. Left ventricular and biventricular pacing in congestive heart failure. Mayo Clin Proc.
2001;76:803-812.
Goldenberg I, Moss AJ, Hall WJ, et al. Predictors of response to cardiac resynchronization therapy in the Multicenter Automatic Defibrillator
Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT). Circulation 2011; 124:1527.
Kadish A, Dyer A, Daubert JP, et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J
Med. 2004;350:2151-2158.
Saxon LA, Bristow MR, Boehmer J, et al. Predictors of sudden cardiac death and appropriate shock in the Comparison of Medical Therapy,
Pacing, and Defibrillation in Heart Failure (COMPANION) Trial. Circulation 2006; 114:2766.
Specialty-matched clinical peer review.
Strickberger SA, Conti J, Daoud EG, et al. Patient selection for cardiac resynchronization therapy. Circulation. 2005;111:2146-2150.
Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the
American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation 2013; 128:1810.