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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(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
Proprietary
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
Biventricular Pacing (Cardiac Resynchronization Therapy)/Combination Resynchronizati... Page 2 of 48
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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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)
33225 Insertion of pacing electrode, cardiac venous
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
Proprietary
Code Code Description
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:
Biventricular Pacing (Cardiac ResynchronizationTherapy)/Combination Resynchroniz... Page 30 of 48
Proprietary
Code Code Description
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:
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 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
cardioverter-defibrillator system with
transvenous lead(s), single or dual chamber
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Proprietary
Code Code Description
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)
Biventricular Pacing (Cardiac ResynchronizationTherapy)/Combination Resynchroniz... Page 32 of 48
Proprietary
Code Code Description
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 [ 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
Biventricular Pacing (Cardiac ResynchronizationTherapy)/Combination Resynchroniz... Page 33 of 48
The above policy is based on the following
Proprietary
Biventricular Pacing (Cardiac ResynchronizationTherapy)/Combination Resynchroniz... Page 34 of 48
references:
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91. Arangalage D, Nguyen V, Robert T, et al. Determinants
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92. Biton Y, Kutyifa V, Cygankiewicz I, et al. Relation of QRS
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93. Sun WP, Li CL, Guo JC, et al. Long-term efficacy of
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94. Rickard J, Michtalik H, Sharma R, et al. Predictors of
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95. Fauchier L, Alonso C, Anselme F, et al. Position paper
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97. Reddy VY, Miller MA, Neuzil P, et al. Cardiac
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for device-based therapy of cardiac rhythm
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Cardiology Foundation/American Heart Association
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103. Evidence Review Committee Members, Slotwiner DJ,
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104. Hsu JC, Birnie D, Stadler RW, et al. Adaptive cardiac
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decreased risk of incident atrial fibrillation compared
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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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