prior authorization review panel mco policy submission · 2020-07-23 · cardiac resynchronization...

Prior Authorization Review Panel MCO Policy Submission

A separate copy of this form must accompany each policy submitted for review. Policies submitted without this form will not be considered for review.

Plan: Aetna Better Health Submission Date:06/01/2020

Policy Number: 0610 Effective Date: Revision Date: 06/05/2018

Policy Name: Biventricular Pacing (Cardiac Resynchronization Therapy)/Combination Resynchronization-Defibrillation Devices for Congestive Heart Failure

Type of Submission – Check all that apply:

New PolicyRevised Policy* Annual Review – No Revisions Statewide PDL

*All revisions to the policy must be highlighted using track changes throughout the document.

Please provide any clarifying information for the policy below:

CPB 0610 Biventricular Pacing (Cardiac Resynchronization Therapy)/Combination Resynchronization-Defibrillation Devices for Congestive Heart Failure

Clinical content was last revised on 06/05/2018. Additional non-clinical updates were made by Corporate since the last PARP submission, as documented below.

Update History since the last PARP Submission:

01/27/2020-This CPB has been updated with additional references.

Name of Authorized Individual (Please type or print):

Benjamin Alouf, MD, MBA, FAAP

Signature of Authorized Individual:

Proprietary Revised July 22, 2019

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Biventricular Pacing (Cardiac Resynchronization Therapy)/Combination Resynchronizati... Page 1 of 48

(https://www.aetna.com/)

Biventricular Pacing (Cardiac Resynchronization Therapy)/Combination Resynchronization-Defibrillation Devices for Congestive Heart Failure

Policy History

Last Review

01/27/2020

Effective: 04/30/2002

Next

Review: 06/26/2020

Review History

Definitions

Ad d i t ion al Information

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Number: 0610

Policy *Please see amendment for Pennsylvania Medicaid at the end of this CPB.

I. Aetna considers Food and Drug Administration (FDA)

-approved biventricular pacemakers (cardiac

resynchronization therapy) medically necessary for the

treatment of members with congestive heart failure

(CHF) who are in sinus rhythm when either of the

following criteria is met (A or B):

A. New York Heart Association (NYHA) classification of

heart failure III or IV (see Appendix) and all of the

following criteria are met:

1. Left ventricular ejection fraction (LVEF) less than or equal to 35 %; and

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2. QRS duration greater than or equal to 150 msec;

and

3. Member is on an optimal pharmacologic regimen,

defined as 3 months of maximally titrated doses

as tolerated,before implantation, which may

include any of the following, unless

contraindicated:

a. Angiotensin-converting enzyme inhibitor; or

b. Angiotensin receptor blocker; or

c. Beta blocker;or

d. Digoxin; or

e. Diuretics; or

4. Member is at least 40 days post myocardial

infarction (MI).

B. NYHA classification of heart failure II-IV (see

Appendix) and all of the following criteria are met:

1. LVEF less than or equal to 35%; and

2. Left bundle branch block with QRS duration

greater than or equal to 130 msec; and

3. Member is on an optimal pharmacologic regimen,

defined as 3 months of maximally titrated doses

as tolerated, before implantation, which may

include any of the following, unless

contraindicated.

a. Angiotensin-converting enzyme inhibitor; or

b. Angiotensin receptor blocker; or

c. Beta blocker; or

d. Digoxin; or

e. Diuretics; or

4. Member is at least 40 days post MI.

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II. Aetna considers biventricular pacemakers experimental

and investigational for all other indications (e.g., atrial

fibrillation, mild heart failure/NYHA functional class I,

and anti-bradycardia pacing) because their effectiveness

for these indications has not been established.

III. Aetna considers FDA-approved combination

resynchronization-defibrillator devices medically

necessary for members who are at high-risk for sudden

cardiac death when the afore-mentioned criteria are

fulfilled and any of the criteria listed below is met:

A. Members have at least 1 episode of cardiac arrest as a

result of ventricular tachyarrhythmias; or

B. Members have recurring, poorly tolerated sustained

ventricular tachycardia; or

C. Members have a prior heart attack and a documented

episode of non-sustained ventricular tachycardia, wi th

an inducible ventricular tachyarrhythmia; or

D. Members have a prior heart attack and a LVEF of less

than or equal to 30 %.

IV. Aetna considers combination resynchronization-

defibrillator devices experimental and investigational for

all other indications because their effectiveness for

these indications has not been established.

V. Aetna considers cardiac resynchronization therapy with

wireless left ventricular endocardial pacing for the

treatment of heart failure experimental and

investigational because the effectiveness of this

approach has not been established.

VI. Aetna considers the galectin-3 test experimental and

investigational for selection of individuals for cardiac

resynchronization therapy and all other indications (e.g.,

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prediction of outcome in individuals with stable dilated

cardiomyopathy, prognosis of aortic valve

stenosis/heart failure, risk prediction of atrial fibrillation)

because its effectiveness has not been established.

Note: Biventricular pacemakers (cardiac resynchronization

therapy) or combination resynchronization-defibrillator devices

are not considered medically necessary for individuals whose

heart failures or ventricular arrhythmias are reversible or

temporary.

C ontraindications

The following approaches are considered not medically

necessary in persons with these contraindications:

▪ Asynchronous pacing is contraindicated in the presence (or

likelihood) of competitive paced and intrinsic rhythms; or

▪ Unipolar pacing is contraindicated in individuals with an

implanted defibrillator or cardioverter-defibrillator (ICD)

because it may cause unwanted delivery or inhibition of

defibrillator or ICD therapy.

See CPB 0585 - Cardioverter-Defibrillators

also (../500_599/0585.html)

.

Background

Approximately 5 million Americans are currently diagnosed

with heart failure (HF), and more than 500,000 new cases are

diagnosed each year. Up to 50 % of patients with advanced

HF exhibit inter-ventricular conduction delay (ventricular

dysynchrony), which result in abnormal contraction of the

heart. Furthermore, prolonged QRS duration in these patients

causes abnormal septal wall motion, reduced cardiac

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contractility, decreased diastolic filling time and extended

mitral regurgitation. These abnormalities have been reported

to be associated with increased morbidity and mortality.

Biventricular pacing has been examined as a technique to

coordinate the contraction of the ventricles, thus improving the

hemodynamic status of the patient. Two approaches are

being studied: (i) incorporation of biventricular pacing into

automatic implantable cardiac defibrillators; and (ii)

development of stand-alone biventricular pacemakers.

Cardiac resynchronization therapy (CRT) refers to pacing

techniques that alter the degree of atrial and ventricular

electromechanical asynchrony in patients with severe atrial

and ventricular conduction disorders. These devices provide

electrical stimulation to both sides of the heart (left and right)

thereby synchronizing atrioventricular contractions and

coordinating (resynchronizing) ventricular

contractions. Ventricular resynchronization has been shown to

result in greater clinical value than atrial resynchronization.

Individuals with dyssynchrony (the right and left ventricles do

not contract and empty simultaneously) and who are at risk for

developing life threatening arrhythmias, may be considered for

implantation of a cardiac resynchronization

therapy/implantable cardioverter defibrillator (CRT-ICD), which

provides the dual function of CRT and an implantable

cardioverter defibrillator. The dual role allows for coordinating

ventricular contractions and terminating life threatening

arrhythmias.

In 1998, the American College of Cardiology and the American

Heart Association issued a joint guideline for implantation of

cardiac pacemakers and anti-arrhythmia devices. The joint

guideline addressed New York Heart Association (NYHA)

Class III and IV patients and stated that "Preliminary data

suggest that simultaneous biventricular pacing may improve

cardiac hemodynamics and lead to subjective and objective

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symptom improvement". Recent studies have reported that

CRT with biventricular pacing to be beneficial for patients with

congestive heart failure (CHF), improving both hemodynamic

and clinical performance of these patients.

The InSync Biventricular Pacing System (Medtronic,

Minneapolis, MN) is a stand-alone biventricular pacemaker

that has been approved by the Food and Drug Administration

(FDA) for the treatment of patients with NYHA Class III or IV

heart failure, who are on a stable pharmacologic regimen, and

who additionally have a QRS duration of greater than or equal

to 130 msec and left ventricular ejection fraction (LVEF) of less

than 35 %.

The Guidant Cardiac Resynchronization Therapy Defibrillator

System -- the CONTAK RENEWAL -- is a combination

resynchronization-defibrillator device that has been approved

by the FDA. It is indicated for patients who are at high-risk of

sudden death due to ventricular arrhythmias and who have

moderate-to-severe HF (NYHA Class III/IV) including left

ventricular dysfunction (LVEF less than or equal to 35 %) and

QRS duration greater than or equal to 130 msec, and remain

symptomatic despite stable, optimal heart failure drug therapy.

Other combination resynchronization-defibrillator devices

currently on the market include the Boston Scientific COGNIS

and VIVIAN CRT with defibrillator (CRT-D) Systems, and the

Medtronic InSync ICD Model 7272.

There is a lack of evidence that echocardiographic parameters

can improve selection of patients for CRT. Chung and

colleagues (2008) noted that data from single-center studies

suggested that echocardiographic parameters of mechanical

dyssynchrony may improve patient selection for CRT. In a

prospective, multi-center setting, the Predictors of Response to

CRT (PROSPECT) study, these researchers tested the

performance of these parameters to predict CRT response. A

total of 53 centers in Europe, Hong Kong, and the United

States enrolled 498 patients with standard CRT indications

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(NYHA class III or IV heart failure, LVEF less than or equal to

35 %, QRS greater than or equal to 130 ms, stable medical

regimen). Twelve echocardiographic parameters of

dyssynchrony, based on both conventional and tissue

Doppler-based methods, were evaluated after site training in

acquisition methods and blinded core laboratory analysis.

Indicators of positive CRT response were improved clinical

composite score and greater than or equal to 15 % reduction

in left ventricular end-systolic volume at 6 months. Clinical

composite score was improved in 69 % of 426 patients,

whereas left ventricular end-systolic volume decreased gr eater

than or equal to 15 % in 56 % of 286 patients with paired

data. The ability of the 12 echocardiographic parameters to

predict clinical composite score response v aried widely, with

sensitivity ranging from 6 % to 74 % and specificity ranging

from 35 % to 91 %; for predicting left ventricular end-systolic

volume response, sensitivity ranged from 9 % to 77 % and

specificity from 31 % to 93 %. For all the parameters, the area

under the receiver-operating characteristics curve for positive

clinical or volume response to CRT was less than or equal to

0.62. There was large variability in the analysis of the

dyssynchrony parameters. The authors concluded that given

the modest sensitivity and specificity in this multi-center setting

despite training and central analysis, no single

echocardiographic measure of dyssynchrony may be

recommended to improve patient selection for CRT beyond

current guidelines.

Anderson et al (2008) reviewed the status of proposed

dyssynchrony indexes by echocardiography for patient

selection in CRT. The authors concluded that despite the

huge output of publications in this field, they do not presently

advise incorporating ec hocardiographic dyssynchrony

parameters for the selection of candidates for CRT for the

following reasons: (i) no large published clinical trials exist to

demonstrate benefit with a particular dyssynchrony index,

(ii) conflicting results are emerging on the predictive value

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of dyssynchrony indexes, (iii) all the parameters described

to date have either technical or theoretical limitations. A

practical parameter or index for selection of appropriate

patients for CRT should be simple and preferably should not

require offline analysis. Clinically, it will be more important to

identify non-responders to CRT using various clinical,

laboratory, and echocardiographic data with a very high

accuracy. This ideal parameter has not been found.

Hawkins et al (2009) stated that international guidelines

unanimously endorse QRS prolongation to identify candidates

for CRT, based on over 4,000 patients randomized in

landmark trials. Small, observational, non-randomized studies

with surrogate end points have promoted echocardiography as

a superior method of patient selection. Over 30 dyssynchrony

parameters have been proposed. Most lack validation in

appropriate clinical settings, including demonstration of short-

term as well as long-term reproducibility and intra- and inter-

observer variability. Prospective multi-center trials have

proved informative in unexpected ways. In core laboratories,

parameters exhibit striking variability, poor reproducibility, and

limited predictive power. The authors are concerned that

many centers today are using these techniques to select

patients for CRT. Publication density and bias have mis-

informed clinical decision making. These investigators stated

that echocardiographic parameters have no place in denying

potentially life-saving treatment or in exposing patients to

unnecessary risks and draining health care resources. Such

measures should not stray beyond the research environment

unless validated in randomized trials with robust clinical end

points. The electrocardiogram remains a simple, inexpensive,

and reproducible tool that identifies patients likely to benefit

from CRT. Patient selection must use the parameter

prospectively validated in landmark clinical trials: the QRS

duration.

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Sanderson (2009) noted that after the publication of the

PROSPECT trial, the use of echocardiography for the

assessment of mechanical dyssynchrony and as a possible

aid for selecting patients for CRT has been heavily criticized.

Calls have been made to observe the current guidelines and

implant according to the entry criteria of recent major trials.

However, although this approach is currently to be

recommended, the attempt to identify patients who will not

receive the benefits of CRT and whose clinical condition may

be worsened should continue. Professional resources and the

costs to society are high and wasted if devices are implanted

inappropriately; further work is needed to refine the techniques

and new clinical trials performed. A combination of methods

that include finding the site of latest mechanical activation,

myocardial scar localization, and assessing venous anatomy

pre-operatively may help to identify those who will not derive

any benefit or be potentially worsened.

Stellbrink (2009) stated that CRT aims to correct the

mechanical dyssynchrony in patients with heart failure and

broad QRS complex. Until now, indication for CRT is based

mainly on clinical and electrocardiographic criteria. Because

QRS width is only weakly correlated to mechanical

dyssynchrony, imaging techniques such as echocardiography

and magnetic resonance tomography (MRT) seem suitable for

analysis of dyssynchrony. Echocardiography has been

studied in several studies for identification of suitable CRT

candidates. Apart from conventional methods such as M mode

, 2 dimensional-, and Doppler-echocardiography, other

techniques such as tissue Doppler echocardiography, have

been used. Despite many positive results in individual studies

no single echocardiographic parameter was able to predict

positive CRT response in a prospective multi-center trial.

Thus, QRS width remains the "gold standard" for CRT patient

identification at present.

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Biventricular Pacing (Cardiac ResynchronizationTherapy)/Combination Resynchroniz... Page 10 of 48

In a prospective, double-blind, multi-center study, Yu and

associates (2009) examined if biventricular pacing is superior

to right ventricular apical pacing in preventing det erioration of

LV systolic function and cardiac remodeling in patients with

bradycardia and a normal LVEF. These investigators

randomly assigned 177 patients in whom a biventricular

pacemaker had been successfully implanted to receive

biventricular pacing ( n = 89) or right ventricular apical pacing

(n = 88). The primary end points were LVEF and left

ventricular end-systolic volume (LVESV) at 12 months. At 12

months, the mean LVEF was significantly lower in the right-

ventricular-pacing group t han in the biventricular-pacing group

(54.8 +/- 9.1 % versus 62.2 +/- 7.0 %, p < 0.001), with an

absolute difference of 7.4 percentage points, whereas the

LVESV was significantly higher in the right-ventricular-pacing

group than in the biventricular-pacing group (35.7 +/- 16.3 ml

versus 27.6 +/- 10.4 ml, p < 0.001), with a relative difference

between the groups in the change from baseline of 25 % (p <

0.001). The deleterious effect of right ventricular apical pacing

occurred in pre-specified subgroups, including pat ients with

and patients without pre-existing LV diastolic dysfunction.

Eight patients in the right-ventricular-pacing gr oup (9 %) and 1

in the biventricular-pacing gr oup (1 %) had LVEF of less than

45 % (p = 0.02). There was 1 death in the right-ventricular-

pacing group, and 6 patients in the right-ventricular-pacing

group and 5 in the biventricular-pacing group were

hospitalized for HF (p = 0.74). The authors concluded that in

patients with normal systolic function, conventional right

ventricular apical pacing r esulted in adverse LV remodeling

and in a reduction in LVEF; these effects were prevented by

biventricular pacing. Moreover, the authors stated that

randomized trials with longer follow-up periods, larger

samples, and sufficient power to assess clinical outcomes

between these two pacing strategies are needed.

Daubert et al (2009) examined the long-term effects of CRT in

the European cohort of patients enrolled in the REVERSE

(Resynchronization Reverses Remodeling in Systolic Left

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Ventricular Dysfunction) trial. These researchers randomly

assigned 262 recipients of CRT pacemakers or defibrillators,

with QRS greater than or equal to 120 ms and LVEF less than

or equal to 40 % to active (CRT ON; n = 180) versus control

(CRT OFF; n = 82) treatment, for 24 months. Mean baseline

LVEF was 28.0 %. All patients were in sinus rhythm and

receiving optimal medical therapy. The primary study end

point was the proportion worsened by the heart failure (HF)

clinical composite response. The main secondary study end

point was LVESV index (LVESVi). In the CRT ON group, 19

% of patients were worsened versus 34 % in the CRT OFF

group (p = 0.01). The LVESVi decreased by a mean of 27.5

+/- 31.8 ml/m(2) in the CRT ON group versus 2.7 +/- 25.8 ml/m

(2) in the CRT OFF group (p < 0.0001). Time to first HF

hospital stay or death (hazard ratio: 0.38; p = 0.003) was

significantly delayed by CRT. The authors concluded that

after 24 months of CRT, and compared with those of control

subjects, clinical outcomes and LV function w ere i mproved

and LV dimensions were decreased in this patient population

in NYHA functional classes I or II. These findings suggested

that CRT prevents the progression of disease in patients with

asymptomatic or mildly symptomatic LV dysfunction.

In an editorial thataccompanied the afore-mentioned article,

Exner (2009) noted that the REVERSE trial demonstrated a 29

% reduction in the risk of the combined end point of death or

HF events (p = 0.003). This outcome was purely driven by a

reduction in HF events. The proportion of these events that

were actual hospitalizations for HF is unclear. Furthermore,

the average 6-min walk test distance of 361 +/- 108 m

suggested that many of these patients would have been

categorized as NYHA function al class III in past trials, based

on a walk distance of less than 450 m. The author stated that

it is premature to recommend CRT as a routine intervention to

patients with asymptomatic LV dysfunction or those with mildly

symptomatic HF today.

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In September 2010, the FDA approved a new indication for 3

cardiac resynchronization therapy defibrillators (CRT-D) used

to treat certain heart failure patients. The new use is for

patients with left bundle branch block, which occurs when

there is delayed activation and contraction of the left ventricle.

The 3 devices, all manufactured by Boston Scientific Corp.,

are intended to treat patients with left bundle branch block who

have either mild heart failure or heart failure with no apparent

symptoms. CRT-Ds are to be used as an addition to, not a

replacement for, heart failure drug therapy. The FDA based its

approval on the results of the 1,820-patient Multicenter

Automatic Defibrillator Implantation Trial with Cardiac

Resynchronization Therapy (MADIT-CRT) clinical study. The

study, which followed 1, 820 pat ients for an average of nearly 3

years at 110 centers in the Canada, Europe, Israel, and United

States. It compared CRT-D therapy to implantable cardioverter

defibrillator (ICD)-only therapy in specific heart failure patients to

determine whether it reduced the risk of death and heart

failure. In patients with left bundle branch block, who

represented 70 % of the study group, CRT-D showed a

reduction in the risk of death and heart failure by 57

%, as compared to ICD alone. The rate of complications was

considered to be acceptable by the FDA for this device,

however, physicians should ade quately inform patients about

potential complications.

As a condition of FDA approval, Boston Scientific must

conduct 2 post-approval studies. One study will evaluate

complications and long-term mortality benefits of CRT-D in

patients with left bundle branch block identified through the

National Cardiovascular Data Registry. The other will follow

patients from the original MADIT-CRT clinical study every 6

months for 5 years to assess long-term mortality benefits of

CRT-D versus ICD.

The efficacy of CRT in patients with mild or moderate HF was

confirmed by the Resynchronization–Defibrillation for

Ambulatory Heart Failure Trial (RAFT trial). Tang,et al (2010)

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reported on a controlled clinical study that found that, among

patients with NYHA class II or III heart failure, a wide QRS

complex, and left ventricular systolic dysfunction, the addition

of CRT to an ICD reduced rates of death and hospitalization

for heart failure. The investigators randomly assigned 1,798

patients with NYHA class II or III HF, a LVEF of 30 % or less,

and an intrinsic QRS duration of 120 msec or more or a paced

QRS duration of 200 msec or more to receive either an ICD

alone or an ICD plus CRT. The primary outcome was death

from any cause or hospitalization for HF, and subjects were

followed for a mean of 40 months. The primary outcome

occurred in 297 of 894 patients (33.2 %) in the ICD–CRT

group and 364 of 904 patients (40.3 %) in the ICD group

(hazard ratio in the ICD–CRT group, 0.75; 95 % confidence

interval [CI]: 0.64 to 0.87; p < 0.001). In the ICD–CRT group,

186 patients died, as compared with 236 in the ICD group

(hazard ratio, 0.75; 95 % CI: 0.62 to 0.91; p = 0.003), and 174

patients were hospitalized for HF, as compared with 236 in the

ICD group (hazard ratio, 0.68; 95 % CI: 0.56 to 0.83; p <

0.001). However, at 30 days after device implantation,

adverse events had occurred in 124 patients in the ICD-CRT

group, as compared with 58 in the ICD group (p < 0.001).

An assessment by the BlueCross BlueShield Association

(BCBSA, 2011) Technology Evaluation Center (TEC) of

cardiac resynchronization therapy for mild HF concluded that

the use of cardiac resynchronization therapy for mild heart

failure meets the TEC criteria for persons with NYHA class II

heart failure who have a LVEF less than 30% and a QRS

duration of greater than or equal to 130 msec. The use of

cardiac resynchronization therapy for mild HF in other patient

populations (e.g., NYHA class I HF) did not meet TEC criteria.

In a review on CRT in patients with NYHA class I and II HF,

Linde and Daubert (2010) stated that a wider use of CRT in

mildly symptomatic patients to prevent disease progression

needs to be considered in the near future. First, however,

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whether mortality is influenced by CRT needs to be clarified,

as well as the balance between the risks of CRT treatment and

the potential benefits.

van Bommel et al (2011) noted that functional mitral

regurgitation (MR) is a common finding in HF patients with

dilated cardiomyopathy and has important prognostic

implications. However, the increased operative risk of these

patients may result in low-referral or high-denial rate for mitral

valve surgery. Cardiac resynchronization therapy has been

shown to have a favorable effect on MR. The aims of this

study were to (i) evaluate CRT as a therapeutic option in HF

patients with functional MR and high operative risk, and (ii)

examine the effect of MR improvement after CRT on

prognosis. A total of 98 consecutive patients with moderate-

severe functional MR and high operative risk underwent CRT

according to current guidelines. Echocardiography was

performed at baseline and 6-month follow-up; severity of MR

was graded according to a multi-parametric approach.

Significant improvement of MR was defined as a reduction

greater than or equal to 1 grade. All-cause mortality was

assessed during follow-up ( median of 32 [range of 6.0 to 116]

months). Thirteen patients (13 %) died before 6-months follow-

up. In the remaining 85 patients, significant reduction in MR was

observed in all evaluated parameters. In particular, 42

patients (49 %) improved greater than or equal to 1 grade of

MR and were considered MR improvers. Survival was superior

in MR improvers compared to MR non-improvers (log rank p <

0.001). Mitral regurgitation improvement was an independent

prognostic factor for survival (hazard ratio 0.35, CI: 0.13 to

0.94; p = 0.043). The authors concluded that CRT is a

potential therapeutic option in HF patients with moderate-

severe functional MR and high-risk for surgery. Improvement

in MR results in superior survival after CRT.

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Stavrakis et al (2012) stated that atrio-ventricular junction

(AVJ) ablation with permanent pacing improves symptoms in

selected patients with atrial fibrillation (AF). The optimal

pacing modality after AVJ ablation remains unclear. In a meta-

analysis, these investigators examined if CRT is superior to

right ventricular (RV) pacing in this patient population. They

searched the MEDLINE and EMBASE databases for studies

evaluating the effect of CRT versus RV pacing after AVJ

ablation for AF. Pooled risk ratios (RRs) and mean differences

with 95 % CIs were calculated for categorical and continuous

outcomes, respectively, using a random effects model. A total

of 5 trials involving 686 patients (413 in CRT and 273 in RV

pacing group) were included in the analysis. On the basis of

the pooled estimate across the studies, CRT resulted in a non-

significant reduction in mortality (RR = 0.75, 95 % CI: 0.43 to

1.30; p= 0.30) and a significant reduction in hospitalizations for

heart failure (RR = 0.38, 95 % CI: 0.17 to 0.85; p= 0.02)

compared with RV pacing. Cardiac resynchronization therapy

did not improve 6 -min walk distance (mean difference 15.7, 95

% CI: -7.2 to 38.5 m; p = 0.18) and Minnesota Living with

Heart Failure quality-of-life s core (mean difference -3.0, 95 %

CI: -8.6 to 2.6; p = 0.30) compared with RV pacing. The

change in LVEF between baseline and 6 months favored CRT

(mean change 2.0 %, 95 % CI: 1.5 to 2.4 %; p < 0.001). The

authors concluded that CRT may be superior to RV pacing in

patients undergoing A VJ ablation f or AF. Moreover, they

stated that further studies, adequately powered to detect

clinical outcomes, are needed.

Curtis et al (2013) noted that RV pacing restores an adequate

heart rate in patients with AV block, but high percentages of

RV apical pacing may promote left ventricular systolic

dysfunction. These researchers examined if biventricular

pacing might reduce mortality, morbidity, and adverse left

ventricular re-modeling in such patients. They enrolled

patients who had indications for pacing with AV block; NYHA

class I, II, or III HF; and a LVEF of 50 % or less. Patients

received a cardiac-resynchronization pacemaker or ICD (the

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latter if the patient had an indication for defibrillation therapy)

and were randomly assigned to standard RV pacing or

biventricular pacing. The primary outcome was the time to

death from any cause, an urgent care visit for HF that required

intravenous therapy, or a 15 % or more increase in the left

ventricular end-systolic volume index. Of 918 patients

enrolled,691 underwent randomization and were followed for

an average of 37 months. The primary outcome occurred in

190 of 342 patients (55.6 %) in the RV-pacing group, as

compared with 160 of 349 (45.8 %) in the biventricular-pacing

group. Patients randomly assigned to biventricular pacing had

a significantly lower incidence of the primary outcome over

time than did those assigned to RV pacing (hazard ratio, 0.74;

95 % CI: 0.60 to 0.90); results were similar in the pacemaker

and ICD groups. Left ventricular lead-related complications

occurred in 6.4 % of patients. The authors concluded that

biventricular pacing was superior to conventional RV pacing in

patients with AV block and left ventricular systolic dysfunction

with NYHA class I, II, or III HF.

Coburn and Frishman (2014) stated that HF is a major cause

of morbidity and mortality in the United States; however,

reliable biomarkers predicting outcomes of patients suffering

from HF are still not available. Finding a prognostic indicator

in patients with HF could ultimately help improve the quality of

goal-directed care for these patients. A number of recent

studies suggested that galectin-3, a peptide that has been

repeatedly shown to be elevated in the setting of inflammatory

processes, may provide information regarding the

pathophysiologic process underlying HF. If this is the case,

galectin-3 may independently be able to provide more

information regarding prognosis in patients with HF than some

of the more conventional indicators currently in use today (i.e.,

natriuretic peptide, C-reactive protein [CRP]). These

researchers analyzed the most recent and comprehensive

studies that have looked at the utility of galectin-3 as a

prognostic marker in patients with HF. After a thorough

review, they found that the evidence against the use of

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galectin-3 as a prognostic biomarker in HF was too strong to

support its routine use in current clinical settings. However,

many of the studies, both in support of and in opposition to the

prognostic potential of galectin-3, were uniformly limited by

undersized cohorts, and thus the need for further exploration is

clearly warranted.

Atabakhshian et al (2014) examined the relationship between

galectin-3 as a biomarker and ejection fraction and functional

capacity in the patients with compensated systolic HF. In this

study, serum levels of galectin-3 were measured in 76 patients

with compensated HF with NYHA class I to IV and LVEF less

than 45 %. Galectin-3 was measured by an ELISA kit.

Besides, echocardiography was used to evaluate LVEF.

Additionally, functional capacity was determined based on the

patients' ability to perform a set of activities. After all, the data

were analyzed used t-test, Kruskal-Wallis, 1-way ANOVA, and

chi-square test; p < 0.05 was considered as statistically

significant. The patients' age ranged from 45 to 75 years, with

the mean age of 63.85 ± 9 years. In addition 57.9 % of the

patients were male. The results revealed no significant

correlation between galectin-3 and age, body mass index, and

estimated glomerular filtration rate (eGFR). Also, no

significant correlation was observed between galectin-3 levels

and LVEF (p = 0.166) and functional capacity (p = 0.420). Yet,

a significant difference was found between males and females

regarding the mean of galectin-3 (p = 0.039). The authors

concluded that the findings of this study suggested that galectin

3 could not be used as a marker of disease progression in the

patients under treatment, which could probably be the result of

medication use in these patients.

Srivatsan et al (2015) noted that HF continues to be an illness

of daunting proportions with a 4-year mortality touching 50 %.

Biomarkers for prognosticating patients with HF have

generated immense interest. Several studies have been

conducted on a novel biomarker, galectin-3 to assess its

prognostic effect in HF populations. However, the studies

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have generated conflicting results. These investigators

performed a systematic review to assess the utility of

galectin-3 as a prognostic biomarker in HF. They carried out a

literature search using terms “galectin-3 and heart” and

“galectin-3 and heart failure” in Medline, Science Direct,

Scopus, Springer Link, Cochrane Library and Google Scholar

for original articles using a predefined inclusion/exclusion

criteria. A total of 27 original articles were selected for the

systematic review. Multi-variate analysis showed galectin-3 to

be ineffective in predicting all-cause mortality and

cardiovascular mortality especially under the influence of

factors such as eGFR, LVEF, and N-terminal fragment of

B-type natriuretic peptide (NT-proBNP). Galectin-3 was not

found to be superior to NT-proBNP, serum levels of so lub le

ST2 (sST2), GDF-15 or CRP as a predictor of mortality.

However the combination of natriuretic peptides and galectin-3

has been observed to be superior in predicting mortality

compared to either of the biomarkers alone. The role of galectin

3 in re-modelling has not been conclusively proven as seen in

earlier pre-clinical studies. The authors concluded that the

current weight of evidence does not suggest galectin-3 to be a

predictor of mortality. However, assessment of galectin-3 in a

multi-biomarker panel may have a distinct advantage in

prognosticating patients with HF.

Shah and colleagues (2015) stated that CRT reduces

morbidity and mortality in patients with chronic systolic HF

(SHF) and a wide QRS complex. It is unclear whether the

same benefit extends to patients with QRS duration (QRSd) of

less than 130 ms. These investigators performed a meta-

analysis of all randomized controlled trials (RCTs) and

evaluated the effect of implantable CRT defibrillator(CRTD) on

all-cause mortality, HF mortality, and HF hospitalization in

patients with QRSd of less than 130 ms. They performed a

systematic literature search to identify all RCTs, comparing

CRTD therapy with ICD therapy in patients with SHF (EF less

than 35 %) and QRS less than or equal to 130 ms, published

in PubMed, Medline, Embase, Cochrane library, and Google

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scholar from June 1980 through June 2013. The search terms

included CRT, QRS duration, narrow QRS, clinical trial, RCT,

biventricular pacing, heart failure, systolic dysfunction,

dyssynchrony, left ventricular remodeling, readmission,

mortality, survival, and various combinations of these terms.

The authors studied the trends of overall mortality, SHF

mortality, and hospitalizations due to SHF between the 2

groups. Heterogeneity of the studies was analyzed by Q

statistic. A fixed-effect model was used to compute the RR of

mortality due to SHF, while a random-effects model was used

to compare hospitalization due to SHF. Out of a total of

12,100 citations, 4 RCTs comparing CRTD versus ICD therapy

in patients with SHF and QRS of less than or equal to 130 ms

fulfilled the inclusion c riteria. The median follow-up w as 12

months and the cumulative number of patients was 1,177.

Relative risk for all-cause mortality in patients treated with

CRTD was 1.66 with a 95 % CI of 1.096 to 2.515 (p = 0.017)

while for SHF mortality was 1.29 with 9 5% CI of 0.68 to 2.45

(p = 0.42). Relative risk for HF hospitalization in patients

treated with CRTD was 0.94 with 95 % CI of 0.50 to 1.74 (p =

0.84) in comparison to the ICD group. The authors concluded

that CRT defibrillator has no impact on SHF mortality and SHF

hospitalization i n patients with systolic HF with QRS duration

of less than or equal to 130 ms and is associated with higher

all-cause mortality in comparison with ICD therapy.

Friedman and associates (2015) noted that patients with

moderate-to-severe chronic kidney disease (CKD) are poorly

represented in clinical trials of CRT. These researchers

evaluated the real-world comparative effectiveness of CRT-D

versus ICD alone in CRT-eligible patients with moderate-to-

severe CKD. These investigators conducted an inverse

probability-weighted analysis of 10,946 CRT-eligible patients

(EF less than 35 %, QRS greater than 120 ms, NYHA

functional class III/IV) with stage 3 to 5 CKD in the National

Cardiovascular Data Registry (NCDR) ICD Registry,

comparing outcomes between patients who received CRT-D (n

= 9,525) versus ICD only (n = 1,421). Outcomes were

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obtained via Medicare claims and censored at 3 years. The

primary end-point of HF hospitalization or death and the

secondary end-point of death were assessed with Cox

proportional hazards models; HF hospitalization, device

explant, and progression to end-stage renal disease were

assessed using Fine-Gray models. After risk adjustment, CRT

D use was associated with a reduction in HF hospitalization or

death (hazard ratio [HR]: 0.84; 95 % CI: 0.78 to 0.91; p <

0.0001), death (HR: 0.85; 95 % CI: 0.77 to 0.93; p

< 0.0004), and HF hospitalization alone (sub-distribution HR:

0.84; 95 % CI: 0.76 to 0.93; p < 0.009).Sub-group analyses

suggested that CRT was associated with a reduced risk of HF

hospitalization and death across CKD classes. The incidence

of in-hospital, short-term, and mid-term device-related

complications did not vary across CKD stages. The authors

concluded that in a nationally representative population of HF

and CRT-eligible patients, use of CRT-D was associated with

a significantly lower risk of the composite end-point of HF

hospitalization or death among patients with moderate-to-

severe CKD in the setting of acceptable complication rates.

Rickard and colleagues (2016) determined predictors of

response to CRT-D and CRT with pacemaker (CRT-P) utilizing

the methods of systematic review. These investigators

searched Medline, Embase, and the Cochrane Central

Register of Controlled Trials (CENTRAL) from January 1,

1995, as this is the date of first article reporting use of CRT

through October 20, 2014. Paired investigators independently

screened search results to assess eligibility. For inclusion,

investigators abstracted data sequentially and assessed risk of

bias independently. Investigators graded the strength of

evidence as a group. They identified 13,015 unique citations

of which 11,897 were excluded during the abstract screen.

During the full-text screening, these researchers excluded

1,118 citations. 12 studies reported in 15 articles were

included in this review. A left bundle branch (LBBB)

morphology, non-ischemic cardiomyopathy (NICM), and

female gender were generally associated with improved

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outcomes following CRT-D. Sinus rhythm (as compared to

AF) and a wider QRS duration were associated with improved

outcomes following CRT-D albeit with a lower strength of

evidence. There was insufficient evidence to determine

predictors of outcomes in patients undergoing CRT-P. The

authors concluded that a native LBBB, NICM, female gender,

sinus rhythm, and a wider QRS duration are associated with

improved outcomes following CRT-D implant.

2012 ACCF/AHA/HRS focused update was incorporated into

the 2008 guidelines for device-based therapy of cardiac

rhythm abnormalities. This guideline outlines indications for

cardiac resynchronization therapy:

▪ CRT can be useful for persons who have LVEF less than

or equal to 35%, sinus rhythm, a non-LBBB pattern with

a QRS duration greater than or equal to 150 ms, and

NYHA class III/ambulatory class IV with symptoms on

GDMT (LOE: A). (Note: the 2012 ACC/AHA/HRS guideline

changed the QRS duration from 120 ms (2008

ACC/AHA/HRS guideline) to 150 ms).

▪ CRT is indicated for persons who have LVEF less than or

equal to 35%, sinus rhythm, LBBB with a QRS duration

greater than or equal to 150 ms, and NYHA class II, III, or

ambulatory IV, and symptoms on while on guideline-

directed medical therapy (GDMT) (LOE: A for NYHA class

III/IV, LOE: B for NYHA class II).

▪ CRT can be useful for persons who have LVEF less than

or equal to 35%, sinus rhythm, LBBB with a QRS

duration 120 to 149 ms, and NYHA class II, III, or

ambulatory IV with symptoms on GDMT (LOE: B).

▪ CRT is not recommended for patients with NYHA class I

or II symptoms and non-LBBB pattern with QRS

duration less than 150 ms (LOE: B).

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An UpToDate review on “Cardiac resynchronization therapy in

heart failure: Indications” (Adelstein and Saba, 2017) make the

following CRT indication recommendations, which include

persons who are in sinus rhythm and have an LVEF less than

or equal to 35 percent, have optimal evidence-based medical

therapy for at least three months after initial diagnosis (or for at

least 40 days after myocardial infarction) and after treatment of

any reversible causes of persistent HF, in addition to the

following:

▪ QRS greater than or equal to 150 ms with LBBB and

NYHA class II to ambulatory IV heart failure (HF); or

▪ QRS 130-149 ms with LBBB and NYHA class II to

ambulatory class IV HF; or

▪ QRS greater than or equal to 150 ms with non-LBBB and

NYHA class II or ambulatory IV HF.

In a meta-analysis, which included early crossover and 14

randomized trials with 4420 patients (nearly all with NYHA

class III or IV symptoms, mean QRS range 155 to 209 ms),

CRT increased the likelihood of improving by at least one

NYHA class (59 versus 37 percent, RR 1.6, 95% CI 1.3-1.9).

Hospitalizations for HF were reduced 37 percent, and all-

cause mortality was reduced 22 percent, primarily because of

a lower risk of HF-related death (RR 0.64, 95% CI 0.49-0.84)

(Adelstein and Saba, 2017).

The Centers for Medicare & Medicaid Services (CMS) (2018)

NCD decision memo for implantable cardioverter defibrillators

states that while they reference CRT defibrillator devices in the

document, there is no coverage determination made in an

NCD. CRT devices are currently addressed by local Medicare

contractors (LCD).

Cardiac Resynchronization Therapy plus Defibrillator for Patients with Mild Heart Failure

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Biton and co-workers (2016) evaluated the long-term clinical

outcomes of 537 non-LBB block patients with mild HF enrolled

in the Multicenter Automatic Defibrillator Implantation Trial with

Cardiac Resynchronization Therapy (MADIT-CRT) study by

QRS duration or morphology further stratified by PR interval.

At 7 years of follow-up, the cumulative probability of HF

hospitalization or death was 45 % versus 56 % among patients

randomized to ICD and CRT-D, respectively (p = 0.209).

Multivariable-adjusted subgroup ana lysis by QRS duration

showed that patients from the lower quartile QRS duration

group (less than or equal to 134 ms) experienced 2.4-fold (p =

0.015) increased risk for HF hospitalization or death with

CRT-D versus ICD only therapy, whereas the effect of CRT-D

in patients from the upper quartiles group (QRS greater than

134 ms) was neutral (H] =0.97, p = 0.86; p value for interaction

= 0.024). In a second analysis incorporating PR interval (time

from the onset of the P wave to the start of the QRS complex),

patients with prolonged QRS (greater than 134 ms) and

prolonged PR (greater than 230 ms) were protected with

CRT-D (HR = 0.31, p = 0.003), whereas the association was

neutral with prolonged QRS (greater than 134 ms) and shorter

PR (less than or equal to 230 ms;, HR= 1.19, p = 0.386; p

value for interaction = 0.002). The effect was neutral,

regardless of morphology, right bundle branch block (HR =

1.01, p = 0.975), and intra-ventricular conduction delay (HR =

1.31, p = 0.172). The authors concluded that patients with

mild HF but without LBB block morphology did not derive

clinical benefit with CRT-D during long-term follow-up;

relatively shorter QRS was associated with a significantly

increased risk with CRT-D relative to ICD only.

Sun and associates (2016) noted that previous studies of CRT

D therapy used for primary prevention of sudden cardiac death

have suggested that CRT-D therapy is less effective in

patients with mild HF and a wide QRS complex. However, the

long-term benefits are variable. These researchers performed

a meta-analysis of randomized trials identified in systematic

searches of Medline, Embase, and the Cochrane Database. A

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total of 3 studies (3,858 patients) with a mean follow-up of 66

months were included. Overall, CRT-D therapy was

associated with significantly lower all-cause mortality than was

ICD therapy (OR, 0.78; 95 % CI: 0.63 to 0.96; p = 0.02; I (2) =

19 %). However, the risk of cardiac mortality was comparable

between 2 groups (OR, 0.74; 95 % CI: 0.53 to 1.01; p = 0.06);

CRT-D treatment was associated with a significantly lower risk

of hospitalization for HF (OR, 0.67; 95 % CI: 0.50 to 0.89; p =

0.005; I (2) = 55 %). The composite outcome of all-cause

mortality and hospitalization for HF was also markedly lower

with CRT-D therapy than with ICD treatment alone (OR, 0.67;

95 % CI: 0.57 to 0.77; p < 0.0001; I (2) = 0 %). The authors

concluded that CRT-D therapy decreased the long-term risk of

mortality and HF events in patients with mild HF with a wide

QRS complex. However, long-term risk of cardiac mortality

was similar between 2 groups. They stated that more

randomized studies are needed to confirm these findings,

especially in patients with NYHA class I HF or patients without

LBBB.

Cardiac Resynchronization Therapy for the Treatment of Atrial Fibrillation

Gianni and colleagues (2017) stated that although CRT is an

important treatment of symptomatic HF patients in sinus

rhythm with low LVEF and ventricular dyssynchrony, its role is

not well-defined in patients with AF. The authors stated that

CRT is not as effective in patients with AF because of

inadequate biventricular capture and loss of AV synchrony.

Both can be addressed with catheter ablation of AF. It is still

unclear if these therapies offer additive benefits in patients

with ventricular dyssynchrony.

Cardiac Resynchronization Therapy with Wireless Left Ventricular Endocardial Pacing for the Treatment of Heart Failure

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Reddy and colleagues (2017) noted that a total of 30 % to 40

% of patients with CHF eligible for CRT either do not respond

to conventional CRT or remain untreated due to an inability or

impediment to coronary sinus (CS) lead implantation. The

WiSE-CRT system (EBR Systems, Sunnyvale, CA) was

developed to address this at-risk patient population by

performing bi-ventricular pacing v ia a wireless LV endocardial

pacing electrode. The SELECT-LV (Safety and Performance

of Electrodes implanted in the Left Ventricle) study is a

prospective, multi-center, non-randomized trial evaluating the

safety and effectiveness of the WiSE-CRT system. A total of

35 patients indicated for CRT who had "failed" conventional

CRT underwent implantation of an LV endocardial pacing

electrode and a subcutaneous pulse generator. System

performance, clinical efficacy, and safety events were

assessed out to 6 months post-implant. The procedure was

successful in 97.1 % (n = 34) of attempted implants. The most

common indications for endocardial LV pacing were difficult

CS anatomy (n = 12), failure to respond to conventional CRT

(n = 10), and a high CS pacing threshold or phrenic nerve

capture (n = 5). The primary performance end-point, bi-

ventricular pacing on the 12-lead electrocardiogram (EKG) at 1

month, was achieved in 33 of 34 patients. A total of 28

patients (84.8 %) had improvement in the clinical composite

score at 6 months, and 21 (66 %) demonstrated a positive

echocardiographic CRT response (greater than or equal to 5

% absolute increase in LVEF). There were no peri-cardial

effusions, but serious procedure/device-related events

occurred in 3 patients (8.6 %) within 24 hours, and 8 patients

(22.9 %) between 24 hours and 1 month. The authors

concluded that the SELECT-LV study demonstrated the

clinical feasibility of the WiSE-CRT system, and provided

clinical benefits to a majority of patients within an otherwise

"failed" CRT population. This clinical trial is still ongoing, but

not recruiting subjects (Last updated September 27, 2016).

Prognosis of Aortic Valve Stenosis

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Arangalage and colleagues (2016) stated that myocardial

fibrosis has been proposed as an outcome predictor in

asymptomatic patients with severe aortic stenosis (AS) that

may lead to consider prophylactic surgery. It can be detected

using MRI but its widespread use is limited and development

of substitute biomarkers is highly desirable. These

researchers analyzed the determinants and prognostic value

of galectin-3, one promising biomarker linked to myocardial

fibrosis. Patients with at least mild degenerative AS enrolled

between 2006 and 2013 in 2 ongoing studies,

COFRASA/GENERAC (COhorte Française de Rétrécissement

Aortique du Sujet Agé/GENEtique du Rétrécissement

Aortique), aiming at assessing the determinants of AS

occurrence and progression, constituted the study population.

These investigators prospectively enrolled 583 patients. The

mean galectin-3 value was 14.3 ± 5.6 ng/ml. There was no

association between galectin-3 and functional status (p = 0.55)

or AS severity (p = 0.58). Independentdeterminants of galectin

3 were age (p = 0.0008), female gender (p = 0.04), hypertension

(p = 0.002), diabetes (p = 0.02), reduced LVEF (p = 0.01),

diastolic dysfunction (E/e', p = 0.02) and creatinine clearance (p

< 0.0001). Among 330 asymptomatic patients at baseline,

galectin-3 was neither predictive of outcome in univariate

analysis (p = 0.73), nor after adjustment for age, gender,

rhythm, creatinine clearance and AS severity (p = 0.66). The

authors concluded that in a prospective cohort of patients with a

wide range of AS severity, galectin-3 was not associated with

AS severity or functional status. Main determinants of galectin-3

were age, hypertension and renal function. They stated that

galectin-3 did not provide prognostic information on the

occurrence of AS-related events; and that these findings did not

support the use of galectin-3 in the decision-making process of

asymptomatic patients with AS.

Galectin-3 Test for the Prediction of Outcome in Individuals with Stable Dilated Cardiomyopathy

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Wojciechowska and colleagues (2017) noted that dilated

cardiomyopathy (DCM) is the 3rd cause of HF and the most

frequent cause of heart transplantation ( HT). The value of

biomarkers in prognostic stratification may be important in

identifying pat ients for more advanced treatment. Assessment

of serum galectin-3 (Gal-3) and ST2 as biomarkers of

unfavorable outcome (death and combined end-point: HT or

death or left ventricular assist device [LVAD] implantation) in

stable DCM patients. A total of 107 DCM patients aged 39 to

56 years were included into the study and followed-up for a

mean of 4.8 years; Gal-3 and ST2 concentrations were

measured using ELISA tests. Clinical data, treatment,

laboratory parameters, NT-proBNP, Gal-3 and ST2 measured

at time of inclusion were assessed as risk factors for reaching

the study end-points using log rank test and Cox proportional-

hazards model. During follow-up, 27 patients died, 40

achieved combined end-point; ROC curves indicated cut-off

value of ST2 -- 17.53 ng/ml, AUC-0.65(0.53 to 0.76) and of

NT-proBNP -- 669 pg/ml, AUC 0.61(0.50 to 0.73) for prediction

of death. In multi-variate analysis, ST2 was predictor of death

(HR per unit increase in log ST2 2.705, 95 % CI: 1.324 to

5.528, p = 0.006) and combined end-point (HR per unit

increase in log ST2 2.753, 95 % CI: 1.542 to 4.914, p < 0.001).

The authors concluded that NT-proBNP was predictive

variable only for death in multi-variate analysis; Gal-3

concentration was not associated with adverse outcome; ST2

but not Gal-3 may be useful for predicting adverse outcome in

stable DCM patients.

Appendix

The NYHA classification of HF is a 4-tier system that

categorizes patients based on subjective impression of the

degree of functional compromise. The 4 NYHA functional

classes are as follows:

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Class I:

Patients with cardiac disease but without resulting

limitation of physical activity. Ordinary physical activity

does not cause undue fatigue, palpitation, dyspnea, or

anginal pain. Symptoms only occur on severe

exertion.

Class II:

Patients with cardiac disease resulting in slight

limitation of physical activity. They are comfortable at

rest. Ordinary physical activity (e.g., moderate physical

exertion such as carrying shopping bags up several

flights or stairs) results in fatigue, palpitation, dyspnea,

or anginal pain.

Class III:

Patients with cardiac disease resulting i n marked

limitation of physical activity. They are comfortable at

rest. Less than ordinary activity (i.e., mild exertion)

causes fatigue, palpitation, dyspnea, or anginal pain.

Class IV:

Patients with cardiac disease resulting in inability to

carry on any physical activity without discomfort.

Symptoms of cardiac insufficiency or of the anginal

syndrome may be present even at rest. If any physical

activity is undertaken, discomfort is increased.

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CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

Code Code Description

Biventricular Pacing:

CPT codes covered if selection criteria are met:

33208 Insertion or replacement of permanent

pacemaker with transvenous electrode(s); atrial

and ventricular

33213 Insertion of pacemaker pulse gene rator only;

with existing dual leads

33214 Upgrade of implanted pacemaker system,

conversion of single chamber system to dual

chamber system (includes removal of

previously placed pulse gene rator, testing of

existing lead, insertion of new lead, insertion of

new pulse generator

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 existing generator)


system, for left ventricular pacing, at time of

insertion of pacing cardioverter-defibrillator or

pacemaker pulse gene rator (eg, for upgrade t o

dual chamber system) (List separately in

addition to code for primary procedure)

CPT codes not covered for indications listed in the CPB:

0515T -

0522T

Wireless cardiac stimulation system for left

ventriculare pacing

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82777 Galectin-3

Other CPT codes related to the CPB:

83520 Immunoassay for analyte other than infectious

agent antibody or infectious agent antigen;

quantitative, not otherwise specified [galectin-3

test]

HCP CS codes covered if selection criteria are met:

C 1779 Lead, pacemaker, transvenous VDD single

pass

C 1785 Pacemaker, dual chamber, rate-responsive

(implantable)

C 1882 Cardioverter-defibrillator, other than single or

dual chamber (implantable)

C 1898 Lead, pacemaker, other than transvenous VDD

single pass

C 1900 Lead, left ventricular coronary venous system

C 2619 Pacemaker, dual chamber, non rate-responsive

(implantable)

C 2620 Pacemaker, single chamber, non rate-

responsive (implantable)

C 2621 Pacemaker, other than single or dual chamber

(implantable)

G0448 Insertion or replacement of a permanent pacing

cardioverter-defibrillator system with

transvenous lead(s), single or dual chamber

with insertion of pacing electrode, cardiac

venous sytem, for left ventricular pacing

ICD-10 codes covered if selection criteria are met:


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I50.1 -

I 50.9

Heart failure [members with CHF who are in

sinus rhythm and criteria (A or B) are met]

ICD- 10 codes not covered for indications listed in the CPB:

I 35.0 Nonrheumatic aortic (valve) stenosis [not

covered for prognosis of aortic valve stenosis]

I 42.0 Dilated cardiomyopathy [not covered for

Galectin-3]

I 48.0 Atrial fibrillation

Combination Resynchronization-Defibrillation Devices:

CP T codes covered if selection criteria are met:


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)


system, for left ventricular pacing, at time of

insertion of pacing cardioverter-defibrillator or

pacemaker pulse gene rator (eg, for upgrade t o

dual chamber system) (List separately in

addition to code for primary procedure)

33230 Insertion of pacing cardioverter-defibrillator

pulse generator only; with existing dual leads

33231 with existing multiple leads

33240 Insertion of pacing cardioverter-defibrillator

pulse generator only; with existing single lead

33249 Insertion or replacement of permanent pacing




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33262 Removal of pacing cardioverter-defibrillator

pulse generator with replacement of pacing

cardioverter-defibrillator pulse gene rator; single

lead system

33263 with existing dual lead system

33264 with existing multiple lead system

HCPCS co des covered if selection criteria are met:

C 1779 Lead, pacemaker, transvenous VDD single

pass

C 1785 Pacemaker, dual chamber, rate-responsive

(implantable)

C 1895 Lead, cardioverter-defibrillator, endocardial dual

coil (implantable)

C 1896 Lead, cardioverter-defibrillator, other than

endocardial single or dual coil (implantable)

C 1898 Lead, pacemaker, other than transvenous VDD

single pass

C 1899 Lead, left pacemaker/cardioverter-defibrillator

combination (implantable)

C 1900 Lead, left ventricular coronary venous system

C 2619 Pacemaker, dual chamber, non rate-responsive

(implantable)

C 2620 Pacemaker, single chamber, non rate-

responsive (implantable)

C 2621 Pacemaker, other than single or dual chamber

(implantable)


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G0448 Insertion or replacement of a permanent pacing



with insertion of pacing electrode, cardiac

venous sytem, for left ventricular pacing

ICD-10 codes covered if selection criteria are met [ m embers who are at high risk for sudden cardiac death]:

I20.0

I22.9

I24.0

I25.2

Acute, subacute, and old myocardial infarction

[prior heart attack and episode of non-sustained

VT, with an inducible ventricular

tachyarrhythmia]

I 46.2 Cardiac arrest due to underlying cardiac

condition [ventricular tachyarrhythmias or LVEF

less than or equal to 30%]

I 47.1 Supraventricular tachycardia [with at least 1

episode of cardiac arrest]

I 47.2 Ventricular tachycardia [with at least 1 episode

of cardiac arrest or recurrent tachycardia]

I 48.0 Atrial fibrillation

Z86.74 Personal history of sudden cardiac arrest [as a

result of ventricular tachyarrhythmias or LVEF

less than or equal to 30%]

Cardiac resynchronization therapy with wireless left ventricular endocardial pacing - no specific code:

ICD-10 codes not covered for indications listed in the CPB:

I50.1 -

I 50.9

Heart failure


The above policy is based on the following

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references:

1. Breithardt OA, Stellbrink C, Franke A, et al. Acute effects

of cardiac resynchronization therapy on left ventricular

Doppler indices in patients with congestive heart failure.

Am Heart J. 2002;143(1):34-44.

2. Barold SS. What is cardiac resynchronization therapy?

Am J Med. 2001;111(3):224-232.

3. Saxon LA, De Marco T. Cardiac resynchronization: A

cornerstone in the foundation of device therapy for

heart failure. J Am Coll Cardiol. 2001;38(7):1971-1973.

4. Cazeau S, Leclercq C, Lavergne T, et al. Effects of

multisite biventricular pacing in patients with heart

failure and intraventricular conduction delay. N Engl J

Med. 2001;344(12):873-880.

5. Louis A, Cleland JG, Crabbe S, et al. Clinical Trials

Update: CAPRICORN, COPERNICUS, MIRACLE, STAF,

RITZ-2, RECOVER and RENAISSANCE and cachexia and

cholesterol in heart failure. Highlights of the Scientific

Sessions of the American College of Cardiology, 2001.

Eur J Heart Fail. 2001;3(3):381-387.

6. Francis GS, et al. Pathophysiology and diagnosis of

heart failure. In: Hurst's The Heart. 10th ed. V Fuster,

et al., eds. New York, NY: McGraw Hill; 2001;20:655

685.

7. Abraham WT. Rationale and design of a randomized

clinical trial to assess the safety and efficacy of cardiac

resynchronization therapy in patients with advanced

heart failure: The Multicenter InSync Randomized

Clinical Evaluation (MIRACLE). J Card Fail. 2000;6

(4):369-380.

8. Bristow MR, Feldman AM, Saxon LA. Heart failure

management using implantable devices for ventricular

resynchronization: Comparison of Medical Therapy,

Pacing, and Defibrillation in Chronic Heart Failure

(COMPANION) trial. J Card Fail. 2000;6(3):276-285.

9. Nelson GS, Berger RD, Fetics BJ, et al. Left ventricular

or biventricular pacing improves cardiac function at

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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan

benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,

general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care

services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors

in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely

responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is

subject to change.

Copyright © 2001-2020 Aetna Inc.

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AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number: 0610 Biventricular Pacing (Cardiac Resynchronization Therapy)/Combination Resynchronization-Defibrillation Devices for Congestive

Heart Failure

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania updated 01/27/2020

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http://www.aetnabetterhealth.com/pennsylvania

prior authorization review panel mco policy submission · 2020-07-23 · cardiac resynchronization...

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