Download Biventricular Pacemakers

MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
Original Issue Date (Created):
7/1/2002
Most Recent Review Date (Revised):
11/24/2015
Effective Date:
5/1/2016
POLICY
RATIONALE
DISCLAIMER
POLICY HISTORY
PRODUCT VARIATIONS
DEFINITIONS
CODING INFORMATION
DESCRIPTION/BACKGROUND
BENEFIT VARIATIONS
REFERENCES
I. POLICY
Biventricular pacemakers with or without an accompanying implantable cardiac defibrillator
(i.e., a combined biventricular pacemaker/ICD) may be considered medically necessary as a
treatment of heart failure in patients who meet all of the following criteria:
New York Heart Association (NYHA) Class III or IV;
 Left ventricular ejection fraction  (less than or equal to) 35%;
 Sinus rhythm
 Patients treated with guideline-directed medical therapy (see Policy Guidelines section)
 Either left bundle branch block or QRS duration ≥150 ms*
New York Heart Association class II
 Left ventricular ejection fraction ≤30%
 Sinus rhythm
 Patients treated with a guideline-directed medical therapy (see Policy Guidelines section)
 Either left bundle branch block or QRS duration ≥150 ms*
* U.S. Food and Drug Administration (FDA)‒labeled indications for QRS duration vary by
device. For some devices, FDA approval is based on QRS duration of ≥130 (eg, InSync®
device), while for others, it is based on QRS duration ≥120 ms (eg, CONTAK CD® CRT-D
System). These differences in QRS duration arise from differences in the eligibility criteria in
the trials on which the FDA approval is based.
For patients who do not meet the criteria outlined above, but who have an indication for a
ventricular pacemaker, biventricular pacemakers with or without an accompanying implantable
cardiac defibrillator (ie, a combined biventricular pacemaker/ICD) may be considered medically
necessary as an alternative to a right ventricular pacemaker in patients who meet all of the
following criteria:


NYHA class I, II, III, or IV heart failure;
Left ventricular ejection fraction ≤50%;
Page 1
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007


The presence of atrioventricular (AV) block with requirement for a high percentage of
ventricular pacing (see Policy Guidelines section);
Patients treated with guideline-directed medical therapy (see Policy Guidelines section)
Biventricular pacemakers with or without an accompanying implantable cardiac defibrillator are
considered investigational as a treatment of NYHA class I heart failure who do not meet the
above criteria. There is insufficient evidence to support a conclusion concerning the health
outcomes or benefits associated with this procedure.
Biventricular pacemakers, with or without an accompanying implantable cardiac defibrillator
(i.e., a combined biventricular pacemaker/ICD), are considered investigational as a treatment
for heart failure in patients with atrial fibrillation who do not meet the above criteria. There is
insufficient evidence to support a conclusion concerning the health outcomes or benefits
associated with this procedure.
An intrathoracic fluid-monitoring sensor is considered investigational as a component of a
biventricular pacemaker, as there is insufficient evidence to support a conclusion concerning the
health outcomes or benefits associated with this procedure.
Triple-site (triventricular) CRT, using an additional pacing lead, is considered investigational.
There is insufficient evidence to support a conclusion concerning the health outcomes or
benefits associated with this procedure.
The use of pacemakers or pacemaker monitoring for conditions other than those described in the
policy section is considered investigational, as there is insufficient evidence to support a
conclusion concerning the health outcomes or benefits associated with this procedure.
Policy Guidelines
Policy Definitions
AV block with a requirement for a high percentage of ventricular pacing is considered to be
present when there is either:


3rd degree AV block; or
2nd degree AV block or a PR interval of 300 ms or more when paced at 100 beats per
minute.
Page 2
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
Guideline-directed medical therapy for heart failure is outlined in 2013 American College of
Cardiology Foundation/American Heart Association guidelines for the management of heart
failure.1 [Website]:
http://www.guideline.gov/content.aspx?id=47343&search=american+college+of+cardiology+fo
undation%2famerican+heart+association+guidelines
Cross-references:
MP-1.081 Cardioverter-Defibrillators (Implantable and External)
MP-2.051 Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the
Outpatient Setting
II. PRODUCT VARIATIONS
TOP
[N] = No product variation, policy applies as stated
[Y] = Standard product coverage varies from application of this policy, see below
[N] PPO
[N] HMO
[N] CHIP
[Y] Senior Blue HMO*
[Y] Senior Blue PPO*
[N] Special Care
[N] POS
[N] Indemnity
[Y] FEP PPO**
* Refer to Centers for Medicare and Medicaid (CMS) National Coverage Determination
(NCD) 20.8, Cardiac Pacemakers and 20.8.3 Cardiac Pacemakers: Single Chamber and Dual
Chamber Permanent Cardiac Pacemakers for additional pacemaker indications.
* Refer to Novitas Solutions Local Coverage Article (LCA) A54982 Single Chamber and Dual
Chamber Permanent Cardiac Pacemakers – Coding and Billing.
** Refer to the FEP Medical Policy Manual MP-2.02.10 Biventricular Pacemakers for Treatment
of Heart Failure. The FEP Medical Policy manual can be found at: www.fepblue.org
III. DESCRIPTION/BACKGROUND
TOP
It is estimated that 20% to 30% of patients with heart failure have intraventricular conduction
disorders, resulting in a contraction pattern that is not coordinated and a wide QRS interval on
the electrocardiogram. This abnormality appears to be associated with increased morbidity and
mortality. Biventricular pacemakers using 3 leads (1 in the right atrium, 1 in each ventricle), also
known as CRT, have been investigated as a technique to coordinate the contraction of the
Page 3
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
ventricles, thus improving patients’ hemodynamic status. Several types of CRT devices are
available, including those that incorporate biventricular pacing into automatic implantable
cardiac defibrillators (ICDs), stand-alone biventricular pacemakers, and biventricular
pacemakers that incorporate fluid monitoring via bioimpedance.
Originally developed CRT devices typically used 2 ventricular leads for biventricular pacing.
Devices and implantation techniques have been developed to allow for multisite pacing, with the
goal of improving CRT response. This may be accomplished in 1 of 2 ways: through the use of
multiple leads within the coronary sinus (triventricular pacing) or through the use of multipolar
left ventricular pacing leads, which can deliver pacing stimuli at multiple sites.
Regulatory Status
There are numerous CRT devices, combined ICD-CRT devices (CRT-D), and combined CRT
and fluid monitoring devices. Some of the devices are discussed here. For example, a stand-alone
biventricular pacemaker (InSync® Biventricular Pacing System; Medtronic) has received
approval by FDA for the treatment of patients with NYHA class III or IV heart failure, on a
stable pharmacologic regimen, who also have a QRS duration of 130 ms or longer and a LVEF
of 35% or less. Both Guidant (CONTAK CD® CRT-D System) and Medtronic (InSync® ICD
Model 7272) have received FDA approval for combined cardiac resynchronization therapy
defibrillators for patients at high risk of sudden cardiac death due to ventricular arrhythmias and
who have NYHA class III or IV heart failure with LVEF of 35% or less, QRS duration 130 ms or
longer (≥120 ms for the Guidant device), and remain symptomatic despite a stable, optimal heart
failure drug therapy. In 2006, Biotronik Inc. received FDA approval for its combined ICD-CRT
device with ventricular pacing leads (Tupos LV/ATx CRT-D/Kronos LV-T CRT-D systems2); in
2013, the company received FDA approval for updated ICD-CRT devices (Ilesto/Iforia series).3
In September 2010, FDA expanded the indications for some CRT devices to include patients
with class I and II heart failure. Based on data from the MADIT-CRT study, indications for 3
Guidant (Boston Scientific) CRT-defibrillator devices (Cognis®, Livian®, and Contak Renewal
devices) were expanded to include patients with heart failure who receive stable optimal
pharmacologic therapy for heart failure and who meet any one of the following classifications4:


Moderate-to-severe heart failure (NYHA class III-IV) with ejection fraction less than
35% and QRS duration greater than 120 ms.
Left bundle branch block with QRS greater than or equal to 130 ms, ejection fraction
less than 30%, and mild (NYHA class II) ischemic or nonischemic heart failure or
asymptomatic (NYHA class I) ischemic heart failure.
In April 2014, FDA further expanded the indications for multiple Medtronic CRT devices to
include patients with NYHA functional class I, II, or III heart failure, who have LVEF of 50% or
less on stable, optimal heart failure medical therapy, if indicated, and have AV block that is
expected to require a high percentage of ventricular pacing that cannot be managed with
algorithms to minimize right ventricular pacing. The expanded indication was based on data
Page 4
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
from the BLOCK-HF study, a Medtronic-sponsored RCT to evaluate the use of CRT in patients
with NYHA class I, II, or III heart failure, LVEF ≤50%, and AV block.
Several CRT devices incorporate a fourth lead, providing quadripolar pacing. The Medtronic
Viva™ Quad XT and the Viva Quad S incorporate a fourth lead, the Medtronic Attain
Performa® left ventricular lead, which received clearance for marketing from FDA in August
2014. The Dynagen™ X4 and Inogen™ X4 devices (Boston Scientific, Marlborough, MA)
incorporate a fourth lead. Other CRT devices with quadripolar leads have been approved for use
outside of the United States (eg, St. Jude Quartet™ left ventricular lead).
Multiple devices manufactured by Medtronic combine a CRT with the OptiVol™ monitoring
system. For example, in 2005, the InSync Sentry® system received FDA approval through the
supplemental premarket approval process. This combined biventricular pacemaker/ICD is also
equipped to monitor intrathoracic fluid levels using bioimpedance technology, referred to as
OptiVol™ Fluid Status Monitoring. Bioimpedance measures, defined as the electrical resistance
of tissue to flow of current, are performed many times per day using a vector from the right
ventricular coil on the lead in the right side of the heart to the implanted pacemaker devices;
changes in bioimpedance reflect intrathoracic fluid status and are evaluated based on a computer
algorithm. For example, changes in a patient’s daily average of intrathoracic bioimpedance can
be monitored; differences in the daily average compared with a baseline are reported as the
OptiVol Fluid Index. It has been proposed that these data may be used as an early warning
system of cardiac decompensation or to provide additional feedback, enabling a physician to
further tailor medical therapy. Policy No. 2.02.24 addresses the use of external bioimpedance
devices as stand-alone devices to noninvasively assess cardiac output.
FDA product code: NIK.
IV. RATIONALE
TOP
Biventricular pacemakers and combined biventricular pacemakers/cardiac defibrillators
Cardiac Resynchronization Therapy for Heart Failure: Does CRT Improve Outcomes for
Patients With Heart Failure?
Efficacy of Cardiac Resynchronization Therapy in Advanced Heart Failure (New York Heart
Association Class III/IV)
Use of biventricular pacemakers with or without accompanying implantable cardiac defibrillator
(ICD) for selected patients with advanced heart failure is supported by a large body of clinical
trial evidence. For patients with the following characteristics, this treatment receives a class I
recommendation in the 2005 American College of Cardiology/American Heart Association
(ACC/AHA) guidelines for the diagnosis and management of patients with heart failure,5
supported by the “A” level of evidence:
Page 5
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007





Left ventricular ejection fraction of 35% or less
Sinus rhythm
New York Heart Association (NYHA) functional class III or IV, despite optimal
medical therapy
Cardiac dyssynchrony as defined as a QRS greater than 120 ms
No contraindications for biventricular pacing
The current ACC/AHA guideline is accompanied by a review of the evidence, which states that
more than 4000 patients have been evaluated in randomized controlled trials (RCTs) and that
these trials establish benefit for cardiac resynchronization therapy (CRT) in this patient
population in improving functional status and exercise capacity.
A 2009 TEC Assessment of CRT in mild heart failure6 summarized 5 of the larger trials of CRT
for advanced heart failure, showing that CRT improves quality-of-life (QOL) and functional
status for patients with class III and class IV heart failure. Four of the 5 trials reported
improvements in functional status for the CRT group. Similarly, 4 of the trials reported QOL
measures, with all 4 showing significant improvements for the CRT group. Hospitalizations were
reduced in 2 of the 4 trials, with an additional 2 trials reporting no difference in hospitalizations.
The Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure
(COMPANION) trial,7 which had the highest enrollment and the longest follow-up, reported a
significant improvement in mortality. The other trials reported lower mortality for the CRT
group, which did not reach statistical significance.
A systematic review of 9 RCTs of CRT in class III/IV heart failure was published in 2004.8 This
quantitative analysis revealed the following conclusions: (1) improvement of 3.5% in left
ventricular ejection fraction (LVEF); (2) improved QOL, with weighted mean difference on the
Minnesota Living with Heart Failure Questionnaire (MLHFQ) of 7.6 points (0-100 scale); and
(3) improved functional capacity and a reduction in all-cause mortality of 21%. This analysis
also found some evidence that cardiac morphology may be improved, suggesting that CRT may
prevent, delay, or even reverse the changes in morphology resulting from chronic heart failure
(reverse remodeling).
Efficacy of CRT in Mild Heart Failure (NYHA Class I/II)
Evaluation of CRT in mild heart failure was originally based on a 2009 TEC Assessment.6 There
is less evidence on treatment of mild heart failure compared with that for advanced heart failure,
but clinical trial evidence is available. At least 4 RCTs enrolling over 3000 patients, with followup ranging from 6 months to 2.4 years, have been published to date. A summary of the major
RCTs in mild heart failure is provided.
-CRT Trial
The largest trial published to date was the Multicenter Automatic Implantation Trial–Cardiac
Resynchronization (MADIT-CRT) trial,9 a single-blind trial that randomized 1820 patients with
NYHA class I/II heart failure to an ICD alone or an ICD-CRT device. The MADIT-CRT trial
Page 6
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
reported a reduction for the ICD-CRT group on the primary outcome, ie, death or acute heart
failure exacerbation. The primary end point was reached by 17.2% of patients in the ICD-CRT
group compared with 25.3% of patients in the ICD-alone group. The first component of the
composite outcome, acute heart failure events, occurred in 22.8% of patients in the ICD-alone
group compared with 13.9% of patients in the ICD-CRT group (relative risk reduction, 39%;
absolute risk reduction, 8.9%; number needed to treat, 11.2). This difference in acute heart
failure events accounted entirely for the difference on the primary composite outcome. The death
rate was similar between groups.
A follow-up publication from the MADIT-CRT trial was published in 2011 and analyzed the
reduction in recurrent heart failure events.10 This analysis supplemented the original MADITCRT outcome of time to first heart failure event, by comparing total heart failure events during
an average follow-up of 2.6 years. Over this time period, there was a 38% relative reduction in
heart failure events in the CRT group (hazard ratio [HR], 0.62; 95% confidence interval [CI],
0.45 to 0.85; p=0.003). On subgroup analysis, the benefit was evident in patients with left bundle
branch block (LBBB; HR=0.50; 95% CI, 0.33-0.76; p=0.001) but not in patients without LBBB
(HR=0.99; 95% CI, 0.58 to 1.69; p=0.96).
In 2014, Goldenberg et al published an analysis of mortality in the MADIT-CRT trial subjects
with follow-up through 7 years, stratified by the presence or absence of LBBB.11 Follow-up was
available for a median 5.6 years among all 1691 surviving patients enrolled in the trial, and
beyond that for 854 subjects enrolled in posttrial registries. Seventy-three percent and 75% of the
implantable cardiac defibrillators (ICD)‒only and ICD-CRT groups, respectively, had LBBB;
69% of each group had QRS duration of a least 150 ms. At 7 years of follow-up, the cumulative
rate of death from any cause among patients with LBBB was 29% in the ICD-only group,
compared with 18% in the ICD-CRT group (unadjusted log-rank test; p=0.002; adjusted HR in
the ICD-CRT group, 0.59; 95% CI, 0.43 to 0.80; p<0.001). The benefit associated with ICDCRT was consistent in subgroup analysis among patients with prolonged QRS (≥150 ms) and
shorter QRS (<150 ms). In multivariable analysis, there was no significant interaction between
QRS duration and overall survival. In the subgroup of 143 patients with LBBB and ischemic
NYHA class I heart failure, ICD-CRT was not significantly associated with a survival benefit,
although the point estimate for the HR was in the direction of benefit (HR=0.66; 95% CI, 0.30 to
1.42; p=0.29). Among patients without LBBB, there was no significant difference in the
cumulative rate of death from any cause between the ICD-only and ICD-CRT groups. However,
the point estimate for hazard ratio for death comparing ICD-only with ICD-CRT therapy
suggested possible harm with ICD-CRT therapy in patients with LBBB (adjusted HR in the ICDCRT group, 1.57; 95% CI, 1.03 to 2.39; p=0.04).
Also in 2014, Kutyifa et al evaluated whether prolonged PR predicts heart failure or death among
with 537 (30%) of MADIT-CRT trial subjects who did not have a LBBB.12 Among the 96
patients with a prolonged PR interval, compared with ICD therapy alone, ICD-CRT treatment
was associated with reduced risk of heart failure or death (HR=0.27; 95% CI, 0.13 to 0.57;
p<0.001). In contrast, among the 438 subjects with a normal PR interval, ICD-CRT treatment
Page 7
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
was associated with a nonsignificant trend toward increased risk of heart failure or death
(HR=1.45; 95% CI, 0.96 to 2.19; p=0.078).
RAFT Trial
A second, large RCT was the Resynchronization-Defibrillation for Ambulatory Heart Failure
Trial or (RAFT) trial,13 which randomized 1798 patients with class II/III heart failure to ICDCRT or ICD alone, with a mean follow-up 40±20 months. Unlike most previous trials, this trial
did not confine enrollment to patients with sinus rhythm but allowed patients with atrial
arrhythmias to participate. However, the number of patients who were not in sinus rhythm was
only 12.8% (229/1798). The RAFT trial was included in a 2011 TEC Assessment. On formal
quality assessment as part of the TEC Assessment, this trial met all quality indicators and was
given a “good” quality rating.
The primary outcome, death from any cause or hospitalization for heart failure, was reduced in
the ICD-CRT group compared with the ICD-alone group (33.2% vs 40.3%, respectively;
p<0.001). There were significant reductions in both individual components of the primary
outcome, overall mortality (20.8% vs 26.1%; p=0.003) and hospitalizations (19.5% vs 26.1%, all
respectively; p<0.001). When restricted to patients with NYHA class II heart failure, the
improvements in the outcomes of mortality and hospitalizations remained significant. The
mortality for class II patients in the ICD-CRT group was 15.5% versus 21.1% in the ICD-alone
group (HR=0.71; 95% CI, 0.56 to 0.91; p<0.006). Hospitalizations for class II patients occurred
in 16.2% of patients in the ICD-CRT group compared with 21.1% in the ICD-alone group
(HR=0.70; 95% CI, 0.55 to 0.89; p<0.003).
In a preplanned substudy of RAFT focusing on hospitalization rates over the 18-month follow-up
period, Gillis et al reported that the fewer patients in the ICD-CRT group were hospitalized for
heart failure compared with those in the ICD-alone group (11.3% vs 15.6%; p=0.003).14
Although the total number of hospitalizations for any cause was lower in the ICD-CRT group
(1448 vs 1553; p=0.042), patients randomized to ICD-CRT had more hospitalizations for devicerelated indications (246 vs 159; p<0.001).
Subgroup analyses from the RAFT trial reported that female sex, QRS duration 150 ms or more,
LVEF less than 20%, and QRS morphologic features were predictive of benefit. Of these factors,
the QRS duration was the strongest factor. Patients with a QRS duration 150 ms or more had a
relative risk (RR) for the primary outcome of approximately 0.50, compared with an RR of
approximately 1.0 for patients with a QRS duration less than 150 ms (p=0.003 for difference
between RRs). There was a trend for greater improvement in patients with sinus rhythm
compared with patients with atrial arrhythmias, but this difference did not reach statistical
significance.
REVERSE Trial
The Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction
(REVERSE) trial15 enrolled a total of 610 patients, all of whom received a CRT device. Patients
were randomized to CRT-ON or CRT-OFF for a period of 12 months in double-blind fashion.
Page 8
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
The primary outcome was a composite measure that classified patients as improved, unchanged,
or worse. There were no significant differences reported on this primary outcome. There was a
decrease in hospitalizations for heart failure in the CRT-ON group (4.1%, 17/419) compared
with the CRT-OFF group (7.9%, 15/191). Changes in functional status, as measured by the 6minute walk, were similar between groups. QOL, as measured by the MLHFQ, was also similar
between groups.
Long-term follow-up from the REVERSE trial subjects who were initially randomized to CRTON were published by Linde et al in 2013.16 At a mean follow-up time of 54.8 months, 53
patients died, with death due to heart failure in 21 (40%), sudden cardiac death in 10 (19%), and
for noncardiac causes in 22 (42%). Annualized and 5-year rates of the composite outcome of
death or first heart failure hospitalization were 6.4% and 28.1%, respectively.
MIRACLE ICD Trial
The Multicenter InSync ICD Randomized Clinical Evaluation MIRACLE ICD study17 was the
smallest of the 3 studies, enrolling 186 patients with class II heart failure and an indication for an
ICD in an unblinded fashion. Patients were randomized to ICD/CRT-ON versus ICD/CRT-OFF
and followed for 6 months. There was no difference in the primary outcome of peak oxygen
uptake between groups. There were also no differences reported between groups on the
secondary outcomes of functional status, as measured by the 6-minute walk, QOL, as measured
by the MLHFQ, and NYHA heart failure class.
Systematic Reviews of CRT for Heart Failure
Numerous systematic reviews and meta-analyses have been published on CRT for heart
failure.8,18-23 Most compare CRT with medical management and report that outcomes are
improved for patients with advanced heart failure and for patients with mild heart failure. For
example, a meta-analysis of 25 trials of CRT was published in February 2011 by Al-Majed et
al.19 This study focused on the analysis of trials with class I/II heart failure patients, identifying 6
trials treating 4572 patients. There was a significant mortality benefit associated with CRT on
combined analysis (6 trials, 4572 participants; RR=0.83 [95% CI, 0.72 to 0.96]). This mortality
benefit was driven largely by the results of the RAFT trial, which had the most number of events
and was given the greatest weight in combined analysis. There was also a significant reduction in
heart failure hospitalizations associated with CRT use (4 trials, 4349 participants; RR=0.71 [95%
CI, 0.57 to 0.87]). There were no significant benefits reported for QOL, functional status, or
progression to more advanced stages of heart failure.
A systematic review and meta-analysis by Chen et al published in 2013, evaluated studies that
compared CRT plus implantable cardioverter defibrillator (CRT-D) to ICD therapy alone.24 The
authors included 8 RCTs including 5674 patients comparing the efficacy of CRT-D with ICD
therapy that met their inclusion criteria. Follow-up in these studies ranged from 3 to 12 months.
In pooled analysis, CRT-D was associated with lower mortality compared with ICD therapy
alone (pooled OR=0.80; 95% CI, 0.67 to 0.95); and was also associated with a lower
hospitalization rate (OR=0.70; 95% CI, 0.6 to 0.81). On subgroup analysis of studies that
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MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
reported mortality at 3- to 6-month follow-up, there was a trend toward mortality improvement
with CRT-D, but this difference was not statistically significant (pooled OR=0.73; 95% CI, 0.461.18). Longer term follow up outcomes of greater than 1 year were not reported in the included
trials.
Adverse Effects of CRT Placement
Complications in the main RCTs were not uniformly reported; however, each trial contained
some information on short- and long-term complications. Short-term complication rates ranged
from 45% to 22%, with lead dislodgement and hematoma at the access site the most common.
Long-term complications were reported by 2 of the trials,15,17 with rates of 16% and 35%,
respectively. Most of these long-term complications were lead dislodgement.
A systematic review and meta-analysis was published in 2011 that focused on complications
from CRT treatment.25 This review included 7 trials of CRT treatment that reported on inhospital mortality and complications related to device placement. In all 7 CRT trials, the device
was placed percutaneously without a thoracotomy. In-hospital mortality occurred at a rate of
0.3%, and 30-day mortality was 0.7%. The most common complications were related to
placement of the left ventricular (LV) lead. Lead dislodgement occurred in 5.9% of patients.
Other LV lead placement complications included coronary vein dissection in 1.3% and coronary
vein perforation in 1.3%. Pneumothorax occurred in 0.9% of patients, and hematoma at the
insertion site occurred in 2.4% of patients.
Section Summary
There is a large body of clinical trial evidence that supports the use of CRT in patients with
NYHA class III/IV heart failure. These trials establish that CRT treatment leads to reduced
mortality, improved functional status, and improved QOL.
For patients with milder heart failure, at least 4 RCTs of CRT have been published. A mortality
benefit was reported by 1 of the 4 trials, the RAFT trial. This trial was free of major bias and
reported a fairly large absolute difference in overall mortality of 5.3%. None of the other 3 RCTs
reported a mortality difference. While 2 of the other 3 trials were underpowered to detect
differences in mortality, the MADIT-CRT was approximately the same size as the RAFT trial
and did not show any improvement in mortality. In subgroup analysis of the MADIT-CRT trial,
a mortality benefit was shown in patients with LBBB. It is possible that the sicker patient
population and longer follow-up in RAFT accounted for the mortality difference. Among other
outcome measures, hospitalizations for heart failure showed consistent improvements, but QOL
and functional status did not. Given the small proportion of patients with NYHA class I heart
failure included in trials, the evidence is insufficient to determine whether patients with NYHA
class I heart failure benefit from CRT.
Page 10
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
CRT for Heart Failure and Atrial Fibrillation: Does CRT Improve Outcomes for Patients
With Atrial Fibrillation and Heart Failure?
There is controversy about whether CRT leads to health outcome benefits for patients with atrial
fibrillation (AF). Many experts feel that if CRT is to be used, it needs to be combined with
ablation of the atrioventricular (AV) node, to avoid transmission of atrial impulses through the
node that might result in rapid ventricular rates, thus undermining the efficacy of CRT.
An RCT was published in 201126 that compared CRT with right ventricular (RV) pacing alone in
patients with AF. A total of 186 patients had AV nodal ablation and implantation of a CRT
device. Patients were then randomized to echo-optimized CRT or RV pacing alone and followed
for a median of 20 months. The primary outcome measure was a composite of death from heart
failure, hospitalization for heart failure, or worsening heart failure. This combined end point
occurred in 11% of the CRT group compared with 26% of the RV pacing group (HR=0.37; 95%
CI, 0.18 to 0.73; p=0.005). For the individual outcome measures, there was not a significant
reduction in mortality (HR=1.57; 95% CI, 0.58 to 4.27; p=0.37), but there were significant
reductions in hospitalizations (HR=0.20; 95% CI, 0.06 to 0.72; p=0.013) and worsening heart
failure (HR=0.27; 95% CI, 0.12 to 0.58; p=0.37). There were no differences in outcomes on
subgroup analysis, including analysis by ejection fraction, NYHA class, and/or QRS duration.
A post hoc analysis of patients with AF enrolled in the RAFT RCT was published by Healey et
al in 2012.27 Randomization in the RAFT trial was stratified for the presence of AF, resulting in
114 patients with AF in the CRT plus defibrillator group and 115 patients with AF in the
defibrillator group alone. There was no difference between groups in the primary outcome of
death or hospitalization due to heart failure (HR=0.96; 95% CI, 0.65 to 1.41; p=0.82). There
were also no differences in cardiovascular death or functional status. There was a trend for
patients in the CRT group to have fewer hospitalizations for heart failure compared with the
defibrillator-alone group, but the difference did not reach statistical significance.
A systematic review published in 201128 compared outcomes of CRT in patients with and
without AF. This analysis included 23 observational studies enrolling 7495 patients, 1912 of
whom had AF. Outcomes in patients with AF were less favorable on all measures. This included
overall mortality (RR=1.5; 95% CI, 1.08 to 2.09; p=0.015), nonresponse to CRT (RR=1.32; 95%
CI, 1.12 to 1.55; p=0.001), change in the MLHFQ QOL score (mean difference [MD], -4.1; 95%
CI, -1.7 to -6.6; p=0.001), and change in the 6-minute walk distance (MD = -14.1 meters; 95%
CI, -28.2 to 0.0; p=0.05). Five studies compared outcomes of patients with AF who had AV
nodal ablation with patients who did not have ablation. Pooled analysis from these studies
indicated that AV nodal ablation was associated with a lower rate of nonresponse (RR=0.40;
95% CI, 0.28 to 0.58; p<0.001).
A systematic review that evaluated the role of AV node ablation in patients with AF treated with
CRT was published in 2012.29 This review included nonrandomized studies that reported
outcomes of CRT and medical therapy. Six studies were included, enrolling a total of 768
patients, 339 of whom underwent AV node ablation and 429 who did not. AV nodal ablation was
associated with improvements in the outcomes of all-cause mortality (RR=0.42; 95% CI, 0.26 to
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0.68), cardiovascular mortality (RR=0.44; 95% CI, 0.24 to 0.81), and change in NYHA class
(MD = -0.34; 95% CI, -0.56 to -0.13; p=0.002).
Yin et al published another systematic review and meta-analysis of the effects of AV nodal
ablation that included 13 observational studies (including 1256 patients) of CRT patients with
AF who received either AV nodal ablation or medical therapy.30 In pooled analysis of patients
who had inadequate biventricular pacing (<90% biventricular pacing), AV nodal ablation was
associated with lower risk of all-cause mortality compared with no ablation (RR=0.63; 95% CI,
0.42 to 0.96), along with a reduced risk of CRT nonresponse (RR=0.41; 95% CI, 0.31 to 0.54).
In contrast, among patients with adequate biventricular pacing (>90% biventricular pacing), AV
nodal ablation was not significantly associated with risk of CRT nonresponse (RR=0.97; 95%
CI, 0.72 to 1.32).
Section Summary
There is insufficient evidence to determine whether CRT improves outcomes for patients with
AF and heart failure. Data from 2 RCTs report different results, with one reporting
improvements for patients with AF and another reporting no significant improvements. One
systematic review of observational studies suggests that patients with AF do not achieve the
same degree of benefit as do patients with sinus rhythm. For patients with AF who are
undergoing CRT, a systematic review of nonrandomized studies concluded that when CRT is
used in patients with AF, AV nodal ablation is associated with improved outcomes compared
with no AV nodal ablation.
CRT for Heart Failure and AV Block: Does CRT Improve Outcomes for Patients With AV
Block and Heart Failure?
Patients with heart failure may require pacemakers for symptomatic bradycardia; those patients
have a high risk of mortality or requirement for heart transplant due to progressive heart failure,
which is thought to be due, in part, to dyssynchronous contraction caused by RV pacing.
In 2014, the U.S. Food and Drug Administration (FDA) expanded the indications for several
CRT devices to include patients with NYHA functional class I, II, or III heart failure with LVEF
of 50% or less, with AV block. These patients are expected to require a high percentage of
ventricular pacing that cannot be managed with algorithms to minimize RV pacing. The approval
was based on results of the BLOCK-HF trial, in which patients with an indication for a
pacemaker and NYHA class I, II, or III heart failure were implanted with a combined CRTpacemaker or ICD (if indicated) and randomized to standard RV pacing or biventricular pacing.31
Patients with permanent atrial arrhythmias and intrinsic AV block or AV block due to AV-node
ablation could be enrolled if they met other enrollment criteria. At baseline, patients had to have
evidence that they would require a high percentage of ventricular pacing, either because of
documented 3rd-degree AV block or the presence of a 2nd-degree AV block or a PR interval of
300 ms or more when paced at 100 beats per minute.
Nine-hundred eighteen patients were enrolled, 691 of whom underwent randomization after 30 to
60 days of RV pacing, during which time appropriate pharmacologic therapy was established.
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Approximately half of all enrolled patients (51.6% of the CRT group, 54.1% of the RV pacing
group) had AF. After accounting for censored data due to missing measures of left ventricular
end-systolic volume (LVESV) index, the primary outcome (first event of death from any cause,
an urgent care visit for heart failure requiring intravenous therapy, or an increase in the LVESV
index of 15% or more) occurred in 160 of 349 patients (45.8%) of the biventricular-pacing group
and 190 of 342 (55.6%) of the RV pacing group. In a hierarchical Bayesian proportional-hazards
model, the HR for the primary outcome was 0.74 for the comparison of biventricular pacing
versus right ventricular pacing (95% CI, 0.60 to 0.90; posterior probability of HR = <1:0.9978
[greater than the prespecified threshold for superiority of biventricular to RV pacing of 0.9775]).
The prespecified secondary outcomes of death or urgent care visit for heart failure, death or
hospitalization for heart failure, and hospitalization for heart failure were less likely in the
biventricular pacing group; however, the secondary outcome of death alone was not significantly
different between groups. Left ventricular lead-related complications occurred in 6.4% of
patients.
Results of the BLOCK HF RCT are supported by earlier results from the PACE trial, in which
177 patients with bradycardia and a normal ejection fraction in whom a biventricular pacemaker
had been implanted were randomized to receive biventricular pacing (n=89) or RV apical pacing
(n=88).32 In the trial’s main results, at 12 months postenrollment, subjects who underwent
standard pacing had lower mean LVEF than those randomized to biventricular pacing (54.8% vs
62.2%; p<0.001) and higher mean LVESV (35.7 mL vs 27.6 mL; p<0.001). No significant
differences were reported in QOL or functional measures, or in rates of heart failure
hospitalizations. In long-term follow-up over a mean duration of 4.8 years among 149 subjects,
biventricular pacing continued to be associated with improved left ventricular functioning and
less left ventricular remodeling.33 In addition, during long-term follow-up, heart failure
hospitalization occurred more frequently in the RV pacing group (23.9% vs 14.6%; p<0.001).
Preliminary results of the BIOPACE study (NCT00187278), in which 1810 patients with AV
block without limitations on LVEF were randomized to RV or biventricular pacing and which
was powered to detect differences in mortality, have been presented in abstract form. However,
no results in the peer-reviewed literature were identified.
Section Summary
For patients who have AV block and some degree of LV dysfunction, who would not necessarily
meet conventional criteria for CRT but who require ventricular pacing, 1 large RCT
demonstrated improvements in heart failure-related hospitalizations and urgent care visits among
patients treated with CRT instead of RV pacing alone. For patients who require ventricular
pacing but have no LV dysfunction, results of 1 small RCT suggest that biventricular pacing is
associated with improved measures of cardiac function, but the study was small and
underpowered for the detection of differences in clinical outcomes.
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Predictors of Response to CRT: Are There Additional Criteria That Can Be Used to Select
Patients for CRT Therapy?
For patients who meet indications for CRT treatment, there is a large variability in the magnitude
of response. Some patients do not respond at all, while others have very substantial benefit. As a
result, there is interest in better defining the clinical features that predict response to better target
therapy toward those who will benefit most. There is a large body of literature examining
predictors of outcome after CRT placement, and numerous clinical and demographic factors
have been identified that predict response. A smaller number of predictors have been proposed as
potential selection factors for CRT placement. Two of these potential selection factors will be
reviewed here, ventricular dyssynchrony on echocardiography and a QRS duration of more than
150 to 160 ms.
An example of a study examining general predictors of outcome is The Predictors of Response to
Cardiac Resynchronization Therapy (PROSPECT) study.34 This was a prospective, multicenter
study that evaluated the ability of echocardiographic parameters to predict response to CRT.
Results of this trial indicated that the 12 individual echocardiographic parameters varied widely
in their ability to predict response.35 The sensitivity of these individual measures ranged from 6%
to 74%, and the specificity ranged from 35% to 91%. The authors concluded that it was unlikely
that these echocardiographic measures could improve patient selection for CRT.
Ventricular Dyssynchrony
Observational studies of patients who meet criteria for treatment have shown that measures of
dyssynchrony on echocardiography are correlated with treatment response, as defined by
improvements in LV end systolic volume, ejection fraction, or clinical criteria.36 This finding led
to several clinical trials that assessed whether ventricular dyssynchrony could discriminate
between responders and nonresponders to CRT, for both patients who would otherwise qualify
for CRT and for those who would not (ie, those with a narrow QRS).
A small RCT that compared outcomes of CRT in patients with ventricular dyssynchrony versus
those without was published in 2011.37 A total of 73 patients with class II/IV were evaluated, 44
of whom were found to have dyssynchrony on echocardiography. These 44 patients were
randomized to a combined CRT-defibrillator or a defibrillator alone. Outcomes measures were
peak oxygen consumption (VO2max), NYHA class, and echocardiographic parameters. At 6
months of follow-up, more patients in the CRT group had an increase of at least 1 mL/kg/min in
VO2max (62% vs 50% p=0.04). There were significant within-group improvements in NYHA
class and echocardiographic measures, but the between-group comparisons with the no-CRT
group did not reach statistical significance.
The NARROW-CRT trial38 was an RCT designed to compare CRT with dual chamber ICD
among patients with heart failure (NYHA class II-III) of ischemic origin, ejection fraction of
35% or less, QRS less than 120 ms, and marked mechanical dyssynchrony on echocardiogram.
One hundred twenty patients were randomized to CRT (n=60) or ICD (n=60). For the study’s
primary outcome of the heart failure clinical composite score, compared with those in the ICD
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group, patients in the CRT were more likely to have an improvement in their clinical composite
score at 1 year postimplantation (41% vs 16%, p=0.004). Patients in the CRT group had higher
rates of avoiding the combined end point of heart failure hospitalization, heart failure death, and
spontaneous ventricular fibrillation (p=0.028).
The EchoCRT study (NCT00683696) was intended to evaluate the role of CRT for subjects with
heart failure (NYHA class III or IV) with narrow QRS (<130 ms) and echocardiographic
evidence of ventricular dyssynchrony. All enrolled patients were implanted with an ICD with
CRT, and patients were randomized to either CRT-ON or CRT-OFF. The study was stopped for
futility at the recommendation of the data safety and monitoring board after enrollment of 809
patients; results from the enrolled patients who had been followed for a mean of 19.4 months
were published by Ruschitzka et al.39 Four hundred four patients were randomized to the CRT
group and 405 to the control group. The primary efficacy outcome, death from any cause or
hospitalization for worsening heart failure, occurred in 116 of 404 patients (28.7%) in the CRT
group, compared with 102 of 405 (25.2%) in the control group (HR with CRT=1.20; 95% CI,
0.92 to 1.57; p= 0.15). There was a significantly higher rate of deaths in the CRT group, with 45
of 404 (11.1%) patients dying in the CRT group, compared with 26 of 50 (6.4%) in the control
group (HR=1.81; 95% CI, 1.11 to 2.93; p=0.02).
The Resynchronization Therapy in Normal QRS Trial (RethinQ study)40 randomized 172
patients with a narrow QRS and evidence of dyssynchrony to receive a CRT device, turned on or
not, and followed up for 6 months. CRT-treated patients were not more likely to have
improvement than non-CRT patients (46% vs 41%, respectively, met the end point of
improvement in exercise capacity [VO2peak]). A subset of patients with QRS duration 120 to 130
ms or more showed improvement (p=0.02), whereas patients with QRS less than 120 ms did not
(p=0.45).
QRS Duration
It is well accepted that patients with a QRS complex of less than 120 ms who are not selected for
dyssynchrony do not benefit from CRT. The LESSER-EARTH trial41 was an RCT designed to
compare CRT versus no CRT in patients with a QRS complex of less than 120 ms, whether
ventricular dyssynchrony was present or absent. This trial was terminated early after 85 patients
had been enrolled. Interim analysis revealed futility in achieving benefit on the primary
outcomes, and a trend toward greater adverse events.
A more controversial issue is whether patients with moderately prolonged QRS duration (120150 ms) benefit from CRT, or whether the benefit is confined to patients with a markedly
prolonged QRS (>150-160 ms). Several meta-analyses of the association of QRS duration with
outcomes have been published. The first of these was published in 2011 and evaluated whether
patients with modest prolongations of the QRS complex benefited from CRT.42 This study
identified 5 trials enrolling 5813 patients that reported on outcomes stratified by QRS duration.
There was some variability in the definition of QRS categories, but the authors were able to
categorize studies into those with moderately prolonged QRS, generally 120 to 149 ms, and
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severely prolonged QRS, generally 150 ms or more. For patients with a moderately prolonged
QRS, there was no significant benefit for CRT in reducing composite outcomes of adverse
cardiac events (RR=0.95; 95% CI, 0.82 to 1.10; p=0.49). In contrast, for patients with a severely
prolonged QRS, there was a 40% relative reduction in the composite outcomes (RR=0.60; 95%
CI, 0.53 to 0.67; p<0.001). There were no differences in outcomes on sensitivity analysis
according to NYHA class and ICD status.
Other meta-analyses have come to similar conclusions, reporting benefit in patients with a QRS
of more than 150, and little to no benefit in patients with shorter QRS duration.43-47 In one of
these studies,45 the benefit of CRT was confined to patients with LBBB. There was no benefit
demonstrated for patients with right bundle branch block or intraventricular conduction delay.
These authors suggest that QRS morphology may be as important, or more important, than QRS
duration in prediction response to CRT. In a patient-level meta-analysis of data from 3 RCTs,
including a total of 4076 patients, Zusterzeel et al evaluated whether women with LBBB benefit
from combined ICD-CRT implantation at a shorter QRS duration than men with LBBB.48 For
patients with LBBB and QRS from 130 to 149 ms, women experienced a significant reduction in
risk of heart failure or death (absolute risk difference between ICD-CRT and ICD alone, 23%;
HR=0.24; 95% CI, 0.11 to 0.53; p<0.001), while men had no significant reduction in risk of
heart failure or death (absolute risk difference, 4%; HR=0.85; 95% CI, 0.60 to 1.21; p=0.38).
Both men and women with LBBB and QRS duration longer than 150 ms benefited from ICDCRT therapy, while neither men nor women with LBBB and QRS duration shorter than 130 ms
benefited.
More recent individual studies have addressed the impact of QRS duration and morphology on
CRT-related outcomes. In the MADIT-CRT study, which included patients with NYHA class I
and II heart failure, previously described, survival benefit associated with ICD-CRT implantation
was limited to patients with LBBB.11
In 2013, Peterson et al published results of a retrospective cohort study of Medicare beneficiaries
who underwent combined CRT/ICD implantation to assess associations between QRS duration
and morphology and outcomes.49 Among 24,169 patients admitted for CRT/ICD implantation
and followed for up to 3 years, rates of 3-year mortality and 1-year all-cause rehospitalization
were lowest in patients with LBBB and QRS duration 150 ms or more. Patients with no LBBB
and QRS duration from 120 to 149 ms had an adjusted hazard ratio after controlling for a number
of clinical and demographic confounders (compared with those with LBBB and markedly
prolonged QRS) of 1.52 (95% CI, 1.38 to 1.67).
Section Summary
The optimal selection of patients for CRT treatment remains an active area of investigation. The
presence of dyssynchrony on echocardiography may risk-stratify patients, but it is not a good
discriminator of responders versus nonresponders. RCT evidence is mixed, but overall, suggests
that patients with dyssynchrony without a prolonged QRS duration do not have reduced rates of
death or hospitalization with a CRT-D compared with an ICD alone. In contrast, a QRS duration
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of more than 150 ms, or the presence of LBBB, appears to discriminate well between responders
and nonresponders and represents a potential factor on which patients may be selected for CRT
treatment. Subgroup analyses of RCTs across multiple studies, corroborated by quantitative
pooling of these subgroup analyses in meta-analyses, have reported that a QRS duration of 150
to 160 ms or more or the presence of LBBB is accurate in discriminating responders from
nonresponders.
Triple-Site CRT Triventricular Pacing
Triple-site CRT, or triventricular pacing, is a variation of conventional CRT that uses an
additional pacing lead. The rationale behind triventricular pacing is that a third pacing lead may
improve electromechanical synchrony, thereby leading to better outcomes. Two RCTs have been
published that compared triple-site CRT with conventional CRT. Rogers et al performed a
double-blind RCT in 43 patients referred for CRT.50 All patients had 3 leads implanted, but
patients in the conventional CRT arm had their device programmed to biventricular pacing. The
triventricular group had greater improvements in the 6-minute walk distance compared with the
conventional CRT group (increase of 91 m vs 65 m, p=0.008), and greater improvement on the
MLHFQ (reduction of 24 points vs 18 points, p<0.001). Complications did not differ between
groups; however, because all patients had 3 leads implanted, this was not a valid comparison of
complications for biventricular versus triventricular pacing.
A second RCT was published by Lenarczyk et al in 2012.51 This was a report of the first 100
patients randomized to triple-site or conventional CRT in the Triple-Site versus Standard Cardiac
Resynchronization Therapy Randomized Trial (TRUST CRT). After a follow-up of 1 year, more
patients in the conventional arm were in NYHA class III or IV heart failure compared with the
triple-site CRT group (30% vs 12.5%, p<0.05). Implantation success was similar in the triple-site
and conventional groups (94% vs 98%, respectively, p=NS), but the triple-site implantation was
associated with longer time for implantation and a higher fluoroscopic exposure. In addition,
more patients in the triple-site group required additional procedures (33% vs 16%, p<0.05).
In 2013, Ogano et al published outcomes from a cohort of 58 patients with NYHA class III to IV
heart failure, LVEF 0.35 or less, and a QRS interval of 120 ms or more who received combined
CRT/ICD with either dual-site or triventricular pacing.52 The choice of dual-site or triventricular
pacing was made at the time of CRT/ICD implantation on the basis of hemodynamic response
(left ventricular delta P/delta tmax); those with a better response to triventricular pacing were
assigned to the triventricular group. Follow-up was available for a mean 481 days. Clinical
symptoms and echocardiographic parameters improved for all subjects from enrollment to 6month follow-up. Ventricular arrhythmia was less common in the triventricular pacing group,
occurring in 2 of 22 patients compared with 14 of 36 patients in the dual-site pacing group
(p=0.044). While this study suggests that triple-site pacing may be associated with fewer
ventricular arrhythmias, it is subject to bias due to the method of selecting patients for triple-site
pacing.
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Section Summary
For the use of CRT with triple-site pacing requiring implantation of an additional lead, 2 small
RCTs with limited follow-up report improved functional status and QOL with triple-site CRT
compared with conventional CRT. However, triple-site CRT was also associated with higher
radiation exposure and a greater number of additional procedures postimplantation. Further
studies are needed to better define the benefit/risk ratio for triple-site CRT compared with
conventional CRT.
Combined Automatic ICDs/Biventricular Pacemakers/Intrathoracic Fluid Monitors
Intrathoracic fluid status monitoring has been proposed as a more sensitive monitoring technique
of the fluid status leading to prompt identification of impending heart failure, permitting early
intervention and, it is hoped, a decreased rate of hospitalization. There is a lack of evidence from
RCTs on the efficacy of fluid monitoring compared with usual care. The available evidence
consists of prospective and retrospective uncontrolled studies that evaluate the correlation of
fluid status information with cardiac events.
A prospective cohort of 558 patients from 34 centers identified the number of “threshold
crossing events” and the percent of days with such events as predictors of hospitalization for
severe heart failure using multivariate regression.53 Over a mean of 326 days, 953 threshold
crossing events in 351 patients resulted in 63 hospitalizations among 49 patients. Each
subsequent event was associated with a 36% increased risk of hospitalization; however, the
extent to which the presence of threshold crossing events influenced the decision to hospitalize is
not known.
The Fluid Accumulation Status Trial (FAST) was a prospective trial investigating the use of the
algorithm used to analyze the collected bioimpedance data. In 2011, Abraham et al reported that,
among 156 patients with heart failure implanted with ICD or CRT along with thoracic
impedance fluid measurements, fluid monitoring was more sensitive than daily weights in
predicting worsened heart failure (76% vs 23%, p<0.001).54
The Sensitivity of the InSync Sentry for Prediction of Heart Failure (SENSE-HF) study was
designed to prospectively evaluate the sensitivity of the OptiVol fluid trends feature in predicting
heart failure hospitalizations with signs and/or symptoms of pulmonary congestion and then to
define OptiVol clinical guidelines for patient management. Conraads et al reported results in
2011.55 The study enrolled 501 patients who underwent CRT placement with the OptiVol fluid
monitoring system. During the first 6 months postimplantation, the patient and physician were
blinded to the fluid monitoring results; following that, the physician had access to the fluid
monitoring results and the patient received alerts with a “heart failure” status. In the final phase,
the physician could optimize heart failure treatment based on OptiVol results. During the first
phase, “threshold crossings” in OptiVol results lead to a positive predictive value for subsequent
heart failure hospitalizations of 4.7%. In the second phase, 233 patients received an OptiVol alert
and for 210, their heart failure status was evaluated within 30 days. Heart failure status had
worsened for 80 patients (positive predictive value, 38.1%). The authors concluded that the
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intrathoracic impedance measurements’ sensitivity improved over time but that further literature
is needed to determine the role of thoracic impedance monitoring in clinical care.
The Combined Heart Failure Diagnostics Identify Patients at Higher Risk of Subsequent Heart
Failure Hospitalization (PARTNERS-HF) is a prospective, nonrandomized postmarketing study
conducted in up to 100 U.S. centers that was completed in March 2008 with the goal of
characterizing the relationship between a variety of diagnostic data derived from the implanted
biventricular/ICD devices.56 Results from this trial, published by Whellan et al in 2010, included
694 patients with LVEF 35% or less, NYHA class III or IV heart failure, intrinsic QRS duration
130 ms or more, and implanted with a commercially available CRT/ICD system.57 The authors
used a device diagnostic algorithm, which was considered positive if the patient had 2 of the
following during a 1-month period: long AF duration, rapid ventricular rate during AF, high
(≥60) fluid index, low patient activity, abnormal autonomics (high night heart rate or low heart
rate variability), or notable device therapy (low CRT pacing or ICD shocks), or if they only had a
very high (≥100) fluid index. The device diagnostics were correlated with subsequent heart
failure events. The device diagnostic period was retrospective, but the heart failure prediction
period was prospective. After adjusting for clinical variables, patients with a positive device
diagnostic algorithm had a significantly higher risk of heart failure hospitalization with
pulmonary signs or symptoms within the next month (adjusted HR=4.8; 95% CI, 2.9 to 8.1;
p<0.001).
A number of retrospective studies have evaluated the correlation between in-device diagnostics
and outcomes.
The Medtronic Impedance Diagnostics in Heart Failure (MID-HeFT) study was a retrospective
study designed to investigate the feasibility of predicting heart failure hospitalization based on
intrathoracic bioimpedance and to validate impedance measurements as a surrogate measure of
pulmonary congestion based on pulmonary capillary wedge pressure. The device that was used
was a modified pacemaker and thus was not incorporated into a biventricular pacemaker/ICD. A
total of 9 abstracts are derived from this study. One abstract included 33 patients.58 Among the
10 patients with 26 hospitalizations for heart failure during an 18-month follow-up, thoracic
bioimpedance gradually decreased before the hospitalization, in many instances before the onset
of clinical symptoms.
Gula et al used data from the RAFT trial to validate the integrated diagnostics algorithm, which
uses data related to heart rate and rhythm, intrathoracic fluid monitoring, and activity to create a
risk score, from 1224 patients with implanted devices (741 with combined ICD-CRT devices,
483 with ICDs alone).59 Compared with low-risk months, the relative risk of heart failure
admission in months considered high risk based on the integrated diagnostics algorithm during
high-risk months was 10.7 (95 % CI, 6.9 to 16.6).
Sekiguchi et al retrospectively evaluated “threshold crossings” as a predictor of arrhythmogenic
events among 282 patients with NYHA class III or IV heart failure followed for a mean of 10
months. 60 Patients were categorized into those who had “threshold crossings” (n=145 [51%])
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and those who did not (n=137 [49%]). Tachyarrhythmic events were more common in patients
with threshold crossings than in patients without (3241 vs 1484 events; p<0.001).
Section Summary
The evidence is not sufficient to determine whether intrathoracic fluid monitoring improves
outcomes for patients who receive a CRT device. The available evidence indicates that
intrathoracic monitoring algorithms are associated with heart failure episodes and may be a more
sensitive measure for predicting heart failure exacerbations compared with weight monitoring.
However, there is no published data that report improved outcomes associated with fluid
monitoring. No published RCTs were identified that report on outcomes and/or the utility of
intrathoracic fluid monitoring in the management of patients with heart failure.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1.
Table 1. Summary of Key Active Trials
NCT No.
Ongoing
NCT01522898a
NCT01994252
NCT02137187
NCT02150538
NCT00769457a
NCT01786993a
NCT00187278a
Unpublished
NCT01735916a
NCT00941850
Trial Name
Planned
Enrollment
Completion
Date
Cardiac Resynchronisation Therapy and AV Nodal Ablation Trial in
Atrial Fibrillation (CAAN-AF)
Resynchronization/Defibrillation for Ambulatory Heart Failure Trial
in Patients With Permanent Atrial Fibrillation (RAFT-PermAF)
A Randomized Controlled Trial of Atrioventricular (AV) Junction
Ablation and Biventricular Pacing Versus Optimal Pharmacological
Therapy in Patients With Permanent Atrial Fibrillation
BiventRicular Pacing in prolongEd Atrio-Ventricular intervaL: the
REAL-CRT Study
OptiLink HF Study (Optimization of Heart Failure Management
Using Medtronic OptiVol® Fluid Status Monitoring and Medtronic
CareLink® Network)
MultiPoint Pacing IDE Study
Biventricular Pacing for Atrioventricular Block in Left Ventricular
Dysfunction to Prevent Cardiac Desynchronization
590
Jul 2016
950
Dec 2018
1830
May 2017
164
Dec 2016
1000
Nov 2014
506
1833
Mar 2015
Jun 2015
44
88
Terminated
Jul 2013
1079
May 2014
MIRACLE EF Clinical Study
TRIple-site VENTricular Pacing in Non-responders to Conventional
Dual Ventricular Site Cardiac Resynchronization Therapy
NCT01510652a More Options Available With a Quadripolar Left Ventricular (LV)
Lead pRovide In-clinic Solutions to Cardiac Resynchronization
Therapy (CRT) Challenges (MORE-CRT)
NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial.
Clinical Input Received From Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate
with and make recommendations during this process, through the provision of appropriate
reviewers, input received does not represent an endorsement or position statement by the
physician specialty societies or academic medical centers, unless otherwise noted.
Page 20
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
In response to requests, input was received from 1 physician specialty society and 8 academic
medical centers while this policy was under review in 2012. There was consensus agreement
with the medically necessary statements. For patients with class I heart failure, there was mixed
input as to whether CRT should be medically necessary. Regarding the duration of the QRS
complex, there was acknowledgement that the literature supported use mainly in patients with a
QRS greater than 150 ms, but most reviewers disagreed with restricting CRT use to patients with
a QRS greater than 150 ms because that was not currently the accepted standard of care. For
patients with AF, the input was mixed on whether biventricular pacing improves outcomes.
Summary of Evidence
Evidence from clinical trials and systematic reviews supports the benefit of cardiac
resynchronization therapy (CRT) treatment for patients with New York Heart Association
(NYHA) class III/IV heart failure. For this group, there are improvements in mortality,
functional status, and quality of life. As a result, CRT treatment may be considered medically
necessary for patients with NYHA class III/IV heart failure when criteria are met.
For patients with milder heart failure, randomized controlled trial (RCT) evidence from at least 1
large, high-quality trial reports a mortality benefit for patients with class II heart failure, but
other RCTs do not report a mortality benefit. Several studies report a decrease in hospitalizations
and mortality for class II or combined class I/II patients, but no studies provide evidence of
treatment benefit on functional status or quality-of-life outcomes. Despite the lower level of
evidence available for mild (class II) compared with advanced heart failure, it can be concluded
that the benefit of CRT outweighs the risk for these patients. Therefore, CRT treatment may be
considered medically necessary for class II heart failure patients who meet other clinical criteria
for treatment. The evidence on class I heart failure is not sufficient to permit conclusions, as only
a small number of class I patients have been included in some of the trials, and no benefit has
been demonstrated for this specific subgroup. As a result, CRT is considered investigational for
class I heart failure. Triple-site (triventricular) CRT, using an additional pacing lead, is in
preliminary testing with only a small amount of available evidence and is considered
investigational as an alternative to conventional CRT.
Treatment of patients with atrial fibrillation (AF) and heart failure is controversial. Available
evidence establishes that patients with heart failure probably do not derive the same magnitude
of benefit as do patients with sinus rhythm and that CRT with atrioventricular (AV) nodal
ablation is probably superior to CRT without AV nodal ablation in patients with heart failure.
However, the evidence is insufficient to determine whether CRT treatment is superior to no
treatment for this patient group. In addition, clinical input in 2012 was mixed as to whether
patients with AF should be treated with CRT. Therefore, CRT remains investigational for
patients with AF.
The available evidence indicates that benefit is concentrated in patients with a QRS duration of
more than 150 ms or in patients with a left bundle branch block (LBBB). Conversely, patients
Page 21
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
with a QRS duration of 120 to 150 ms do not benefit. Although clinical input in 2012
demonstrated support for continued use of QRS threshold of 120 ms, rather than restricting
treatment to patients with QRS of more than 150 ms, the evolving evidence since 2012 supports
limiting CRT to patients with widened QRS complexes or LBBB. Other factors for selecting
patients, such as ventricular dyssynchrony on echocardiography, have not been shown to be good
discriminators of responders versus nonresponders.
For patients who have some degree of heart failure and who are candidates for a pacemaker,
evidence from 1 RCT suggests that biventricular pacing is associated with reduced urgent care
visits and hospitalizations for heart failure. Therefore, CRT may be considered medically
necessary for patients with left ventricular ejection fraction of 50% or less and AV block who are
likely to require a high degree of ventricular pacing, as an alternative to right ventricular pacing.
For patients without heart failure but who require a pacemaker, randomized trials are underway
to determine whether biventricular pacing is associated with improved outcomes.
Practice Guidelines and Position Statements
In 2013, American College of Cardiology/American Heart Association (ACC/AHA) Task Force
on Practice Guidelines published guidelines for the management of heart failure.61 These
guidelines make recommendations regarding CRT for heart failure that are in line with those
made by the ACC/AHA and Heart Rhythm Society related to CRT for heart failure outlined next.
A focused update to 2008 guidelines62 for device-based treatment of cardiac rhythm
abnormalities were published jointly by the ACC/AHA/Heart Rhythm Society in 2012.63 These
guidelines included the following recommendations on CRT for heart failure:
Class I Recommendations
 CRT is indicated for patients who have LVEF (left ventricular ejection fraction) less than
or equal to 35%, sinus rhythm, LBBB (left bundle branch block) with a QRS duration
greater than or equal to 150 ms, and NYHA class II, III, or ambulatory IV symptoms on
guideline-directed medical therapy (GDMT). (Level of Evidence: A for NYHA class
III/IV; Level of Evidence: B for NYHA class II)
Class IIa Recommendations
 CRT can be useful for patients 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
symptoms on GDMT. (Level of Evidence: B)
 CRT can be useful for patients 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 symptoms on GDMT. (Level of Evidence: A)
 CRT can be useful in patients with atrial fibrillation and LVEF less than or equal to 35%
on GDMT if a) the patient requires ventricular pacing or otherwise meets CRT criteria
and b) AV nodal ablation or pharmacologic rate control will allow near 100% ventricular
pacing with CRT. (Level of Evidence: B)
Page 22
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007

CRT can be useful for patients on GDMT who have LVEF less than or equal to 35% and
are undergoing new or replacement device placement with anticipated requirement for
significant (>40%) ventricular pacing. (Level of Evidence: C)
Class IIb Recommendations
 CRT may be considered for patients who have LVEF less than or equal to 30%, ischemic
etiology of heart failure, sinus rhythm, LBBB with a QRS duration of greater than or
equal to 150 ms, and NYHA class I symptoms on GDMT. (Level of Evidence: C)
 CRT may be considered for patients who have LVEF less than or equal to 35%, sinus
rhythm, a non-LBBB pattern with QRS duration 120 to 149 ms, and NYHA class
III/ambulatory class IV on GDMT. (Level of Evidence: B)
 CRT may be considered for patients 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 II symptoms on GDMT. (Level of Evidence: B)
Class III Recommendations (no benefit)
 CRT is not recommended for patients with NYHA class I or II symptoms and non-LBBB
pattern with QRS duration less than 150 ms. (Level of Evidence: B)
 CRT is not indicated for patients whose comorbidities and/or frailty limit survival with
good functional capacity to less than 1 year. (Level of Evidence: C)
The European Society of Cardiology and the European Heart Rhythm Association released
guidelines on cardiac pacing and cardiac resynchronization therapy in 2013.64 These guidelines
included the following recommendations on CRT for heart failure with sinus rhythm:
Class I Recommendations
 LBBB with QRS duration greater than 150 ms. CRT is recommended in chronic heart
failure patients and LVEF less than or equal to 35% who remain in NYHA functional
class II, III, and ambulatory IV despite adequate medical treatment. (Level of Evidence:
A).
 LBBB with QRS duration from 120 to 150 ms. CRT is recommended in chronic heart
failure patients and LVE less than or equal to 35% who remain in NYHA functional class
II, III, and ambulatory IV despite adequate medical treatment. (Level of Evidence: B).
Class IIa Recommendations
 Non-LBBB with QRS duration greater than 150 ms. CRT should be considered in
chronic heart failure patients and LVEF less than or equal to 35% who remain in NYHA
functional class II, III, and ambulatory IV despite adequate medical treatment. (Level of
Evidence: B).
Class IIb Recommendations
 Non-LBBB with QRS duration 120-150 ms. CRT may be considered in chronic heart
failure patients and LVEF less than or equal to 35% who remain in NYHA functional
Page 23
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
class II, III, and ambulatory IV despite adequate medical treatment. (Level of Evidence:
B).
Class III Recommendations
 CRT in patients with chronic heart failure with SQR duration less than 120 ms is not
recommended (Level of Evidence: B).
The Heart Failure Society of America released comprehensive guidelines on the management of
heart failure in 2010.65 The guidelines include the following recommendations related to the use
of CRT:





Biventricular pacing therapy is recommended for patients in sinus rhythm with a widened
QRS interval (≥120 ms) and severe LV [left ventricular] systolic dysfunction (LVEF ≤
35%) who have persistent, moderate to severe HF (NYHA III) despite optimal medical
therapy. (Level of Evidence: A).
Biventricular pacing therapy may be considered for patients with atrial fibrillation with a
widened QRS interval (≥120 ms) and severe LV systolic dysfunction LVEF ≤35% who
have persistent, moderate to severe HF (NYHA III) despite optimal medical therapy.
(Level of Evidence: B).
Selected ambulatory NYHA IV patients in sinus rhythm with QRS ≥120 ms and LV
systolic dysfunction may be considered for biventricular pacing therapy. (Level of
Evidence: B).
Biventricular pacing therapy may be considered in patients with reduced LVEF and QRS
≥ 150 ms who have NYHA I or II HF symptoms. (Level of Evidence: B).
In patients with reduced LVEF who require chronic pacing and in whom frequent
ventricular pacing is expected, biventricular pacing may be considered. (Level of
Evidence: C).
U.S. Preventive Services Task Force Recommendations
Not applicable.
V.
DEFINITIONS
TOP
ARRHYTHMIA REFERS to irregularity, or loss of rhythm, of the heart.
NEW YORK HEART ASSOCIATION 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.
Page 24
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
NEW YORK HEART ASSOCIATION CLASS II -Patients with cardiac disease resulting in slight
limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in
fatigue, palpitation, dyspnea or anginal pain.
NEW YORK HEART ASSOCIATION CLASS III-. Patients with cardiac disease resulting in marked
limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes
fatigue, palpitation, dyspnea or anginal pain.
NEW YORK HEART ASSOCIATION CLASS IV- Patients with cardiac disease resulting in inability
to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal
syndrome may be present even at rest. If any physical activity is undertaken, discomfort
increases.
PREMARKET APPROVAL (PMA) is the FDA process of scientific and regulatory review to
evaluate the safety and effectiveness of Class III medical devices. Class III devices are those
that support or sustain human life, are of substantial importance in preventing impairment of
human health, or which present a potential, unreasonable risk of illness or injury.
VI. BENEFIT VARIATIONS
TOP
The existence of this medical policy does not mean that this service is a covered benefit under
the member's contract. Benefit determinations should be based in all cases on the applicable
contract language. Medical policies do not constitute a description of benefits. A member’s
individual or group customer benefits govern which services are covered, which are excluded,
and which are subject to benefit limits and which require preauthorization. Members and
providers should consult the member’s benefit information or contact Capital for benefit
information.
VII. DISCLAIMER
TOP
Capital’s medical policies are developed to assist in administering a member’s benefits, do not constitute medical
advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of
members. Members should discuss any medical policy related to their coverage or condition with their provider
and consult their benefit information to determine if the service is covered. If there is a discrepancy between this
medical policy and a member’s benefit information, the benefit information will govern. Capital considers the
information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law.
Page 25
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
VIII. CODING INFORMATION
TOP
Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The
identification of a code in this section does not denote coverage as coverage is determined by
the terms of member benefit information. In addition, not all covered services are eligible for
separate reimbursement.
Covered when medically necessary:
CPT Codes®
33206
33224
33235
33263
33207
33225
33236
33208
33226
33237
33211
33228
33238
33212
33229
33240
33213
33230
33241
33214
33231
33243
33215
33233
33244
33216
33234
33249
Current Procedural Terminology (CPT) copyrighted by American Medical Association. All Rights Reserved.
HCPCS
Code
C1721
C1777
C1882
C1895
C1896
C1899
G0448
Description
Cardioverter- defibrillator, dual chamber (implantable)
Lead, cardio-defibrillator, endocardial single coil (implantable)
Cardioverter-defibrillator, other than single or dual chamber (implantable
Lead, cardioverter-defibrillator, endocardial dual coil (implantable
Lead, cardioverter-defibrillator, other than endocardial single or dual coil (implantable
Lead, pacemaker/cardioverter-defibrillator combination (implantable
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
system, for left ventricular pacing
ICD-10-Cm
Diagnosis
Code*
Description
I50.1
Left ventricular failure
I50.20
Systolic heart failure
I50.21
Acute systolic heart failure
I50.22
Chronic systolic heart failure
I50.23
Acute on chronic systolic heart failure
I50.30
Unspecified systolic heart failure
Page 26
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
I50.31
Acute diastolic heart failure
I50.32
Chronic diastolic heart failure
I50.33
Acute on chronic diastolic heart failure
I50.40
Unspecified combined systolic and diastolic heart failure
I50.41
Acute combined systolic and diastolic heart failure
I50.42
Chronic combined systolic and diastolic heart failure
I50.43
Acute on chronic combined systolic and diastolic heart failure
I50.9
Heart failure, unspecified
T82.110A
Breakdown (mechanical) of cardiac electrode, initial encounter
T82.111A
Breakdown (mechanical) of cardiac pulse generator (battery), initial encounter
T82.120A
Displacement of cardiac electrode, initial encounter
T82.121A
Displacement of cardiac pulse generator (battery), initial encounter
T82.190A
Other mechanical complication of cardiac electrode, initial encounter
T82.191A
Other mechanical complication of cardiac pulse generator (battery), initial encounter
T82.6XXA
Infection and inflammatory reaction due to cardiac valve prosthesis, initial encounter
T82.7XXA
Infection and inflammatory reaction due to other cardiac and vascular devices, implants
and grafts, initial encounter
T82.817A
Embolism of vascular prosthetic devices, implants and grafts, initial encounter
T82.827A
Fibrosis of cardiac prosthetic devices, implants and grafts, initial encounter
T82.837A
Hemorrhage of cardiac prosthetic devices, implants and grafts, initial encounter
Page 27
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
T82.847A
Pain from cardiac prosthetic devices, implants and grafts, initial encounter
T82.857A
Stenosis of cardiac prosthetic devices, implants and grafts, initial encounter
T82.867A
Thrombosis of cardiac prosthetic devices, implants and grafts, initial encounter
T82.847A
Pain from cardiac prosthetic devices, implants and grafts, initial encounter
*If applicable, please see Medicare LCD or NCD for additional covered diagnoses.
IX. REFERENCES
TOP
1. Writing Committee M, Yancy CW, Jessup M, et al. 2013 ACCF/AHA guideline for the
management of heart failure: a report of the American College of Cardiology
Foundation/American Heart Association Task Force on practice guidelines. Circulation. Oct
15 2013;128(16):e240-327. PMID 23741058
2. FDA. Summary of Safety and Effectiveness Data: Tupos LV/ATx CRT-D, Kronos LV-T CRTD. 2006; http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050023b.pdf. Accessed September
4, 2015.
3. FDA. Approval Order: Biotronic PMA P050023. 2013;
http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050023S058A.pdf. Accessed September 4,
2015.
4. Administration FaD. Summary of Safety and Effectiveness Data: Cardiac Resynchronization
Therapy Defibrillator (CRT-D). 2010;
http://www.accessdata.fda.gov/cdrh_docs/pdf/P010012S230b.pdf. Accessed September 4,
2015.
5. Hunt SA. ACC/AHA 2005 guideline update for the diagnosis and management of chronic
heart failure in the adult: a report of the American College of Cardiology/American Heart
Association Task Force on Practice Guidelines (Writing Committee to Update the 2001
Guidelines for the Evaluation and Management of Heart Failure). J Am Coll Cardiol. Sep 20
2005;46(6):e1-82. PMID 16168273
6. Cardiac resynchronization therapy for mild congestive heart failure. Blue Cross and Blue
Shield Association Technology Evaluation Center TEC Assessment Program. 2009;24(8).
7. Bristow MR, Saxon LA, Boehmer J, et al. Cardiac-resynchronization therapy with or without
an implantable defibrillator in advanced chronic heart failure. N Engl J Med. May 20
2004;350(21):2140-2150. PMID 15152059
8. McAlister FA, Ezekowitz JA, Wiebe N, et al. Systematic review: cardiac resynchronization in
patients with symptomatic heart failure. Ann Intern Med. Sep 7 2004;141(5):381-390. PMID
15353430
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BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
9. Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-resynchronization therapy for the prevention
of heart-failure events. N Engl J Med. Oct 1 2009;361(14):1329-1338. PMID 19723701
10. Goldenberg I, Hall WJ, Beck CA, et al. Reduction of the risk of recurring heart failure events
with cardiac resynchronization therapy: MADIT-CRT (Multicenter Automatic Defibrillator
Implantation Trial With Cardiac Resynchronization Therapy). J Am Coll Cardiol. Aug 9
2011;58(7):729-737. PMID 21816309
11. Goldenberg I, Kutyifa V, Klein HU, et al. Survival with cardiac-resynchronization therapy in
mild heart failure. N Engl J Med. May 1 2014;370(18):1694-1701. PMID 24678999
12. Kutyifa V, Stockburger M, Daubert JP, et al. PR interval identifies clinical response in
patients with non-left bundle branch block: a Multicenter Automatic Defibrillator
Implantation Trial-Cardiac Resynchronization Therapy substudy. Circ Arrhythm
Electrophysiol. Aug 2014;7(4):645-651. PMID 24963007
13. Tang AS, Wells GA, Talajic M, et al. Cardiac-resynchronization therapy for mild-tomoderate heart failure. N Engl J Med. Dec 16 2010;363(25):2385-2395. PMID 21073365
14. Gillis AM, Kerr CR, Philippon F, et al. Impact of cardiac resynchronization therapy on
hospitalizations in the Resynchronization-Defibrillation for Ambulatory Heart Failure trial.
Circulation. May 20 2014;129(20):2021-2030. PMID 24610807
15. Linde C, Abraham WT, Gold MR, et al. Randomized trial of cardiac resynchronization in
mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular
dysfunction and previous heart failure symptoms. J Am Coll Cardiol. Dec 2
2008;52(23):1834-1843. PMID 19038680
16. Linde C, Gold MR, Abraham WT, et al. Long-term impact of cardiac resynchronization
therapy in mild heart failure: 5-year results from the REsynchronization reVErses
Remodeling in Systolic left vEntricular dysfunction (REVERSE) study. European Heart
Journal. Sep 2013;34(33):2592-2599. PMID 23641006
17. Abraham WT, Young JB, Leon AR, et al. Effects of cardiac resynchronization on disease
progression in patients with left ventricular systolic dysfunction, an indication for an
implantable cardioverter-defibrillator, and mildly symptomatic chronic heart failure.
Circulation. Nov 2 2004;110(18):2864-2868. PMID 15505095
18. Adabag S, Roukoz H, Anand IS, et al. Cardiac resynchronization therapy in patients with
minimal heart failure: a systematic review and meta-analysis. J Am Coll Cardiol. Aug 23
2011;58(9):935-941. PMID 21851882
19. Al-Majed NS, McAlister FA, Bakal JA, et al. Meta-analysis: cardiac resynchronization
therapy for patients with less symptomatic heart failure. Ann Intern Med. Mar 15
2011;154(6):401-412. PMID 21320922
20. Bertoldi EG, Polanczyk CA, Cunha V, et al. Mortality reduction of cardiac resynchronization
and implantable cardioverter-defibrillator therapy in heart failure: an updated metaanalysis. Does recent evidence change the standard of care? J Card Fail. Oct
2011;17(10):860-866. PMID 21962425
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BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
21. Nery PB, Ha AC, Keren A, et al. Cardiac resynchronization therapy in patients with left
ventricular systolic dysfunction and right bundle branch block: a systematic review. Heart
Rhythm. Jul 2011;8(7):1083-1087. PMID 21300176
22. Tu R, Zhong G, Zeng Z, et al. Cardiac resynchronization therapy in patients with mild heart
failure: a systematic review and meta-analysis of randomized controlled trials. Cardiovasc
Drugs Ther. Aug 2011;25(4):331-340. PMID 21750900
23. Wells G, Parkash R, Healey JS, et al. Cardiac resynchronization therapy: a meta-analysis of
randomized controlled trials. CMAJ. Mar 8 2011;183(4):421-429. PMID 21282316
24. Chen S, Ling Z, Kiuchi MG, et al. The efficacy and safety of cardiac resynchronization
therapy combined with implantable cardioverter defibrillator for heart failure: a metaanalysis of 5674 patients. Europace. Jul 2013;15(7):992-1001. PMID 23419662
25. van Rees JB, de Bie MK, Thijssen J, et al. Implantation-related complications of implantable
cardioverter-defibrillators and cardiac resynchronization therapy devices: a systematic
review of randomized clinical trials. J Am Coll Cardiol. Aug 30 2011;58(10):995-1000.
PMID 21867832
26. Brignole M, Botto G, Mont L, et al. Cardiac resynchronization therapy in patients
undergoing atrioventricular junction ablation for permanent atrial fibrillation: a randomized
trial. Eur Heart J. Oct 2011;32(19):2420-2429. PMID 21606084
27. Healey JS, Hohnloser SH, Exner DV, et al. Cardiac resynchronization therapy in patients
with permanent atrial fibrillation: results from the Resynchronization for Ambulatory Heart
Failure Trial (RAFT). Circ Heart Fail. Sep 1 2012;5(5):566-570. PMID 22896584
28. Wilton SB, Leung AA, Ghali WA, et al. Outcomes of cardiac resynchronization therapy in
patients with versus those without atrial fibrillation: a systematic review and meta-analysis.
Heart Rhythm. Jul 2011;8(7):1088-1094. PMID 21338711
29. Ganesan AN, Brooks AG, Roberts-Thomson KC, et al. Role of AV Nodal Ablation in Cardiac
Resynchronization in Patients With Coexistent Atrial Fibrillation and Heart Failure A
Systematic Review. J Am Coll Cardiol. Feb 21 2012;59(8):719-726. PMID 22340263
30. Yin J, Hu H, Wang Y, et al. Effects of atrioventricular nodal ablation on permanent atrial
fibrillation patients with cardiac resynchronization therapy: a systematic review and metaanalysis. Clin Cardiol. Nov 2014;37(11):707-715. PMID 25156448
31. Curtis AB, Worley SJ, Adamson PB, et al. Biventricular pacing for atrioventricular block
and systolic dysfunction. New England Journal of Medicine. Apr 25 2013;368(17):15851593. PMID 23614585
32. Yu CM, Chan JY, Zhang Q, et al. Biventricular pacing in patients with bradycardia and
normal ejection fraction. N Engl J Med. Nov 26 2009;361(22):2123-2134. PMID 19915220
33. Yu CM, Fang F, Luo XX, et al. Long-term follow-up results of the pacing to avoid cardiac
enlargement (PACE) trial. Eur J Heart Fail. Sep 2014;16(9):1016-1025. PMID 25179592
34. Yu CM, Abraham WT, Bax J, et al. Predictors of response to cardiac resynchronization
therapy (PROSPECT)--study design. Am Heart J. Apr 2005;149(4):600-605. PMID
15990740
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BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
35. Chung ES, Leon AR, Tavazzi L, et al. Results of the Predictors of Response to CRT
(PROSPECT) trial. Circulation. May 20 2008;117(20):2608-2616. PMID 18458170
36. Hawkins NM, Petrie MC, MacDonald MR, et al. Selecting patients for cardiac
resynchronization therapy: electrical or mechanical dyssynchrony? Eur Heart J. Jun
2006;27(11):1270-1281. PMID 16527827
37. Diab IG, Hunter RJ, Kamdar R, et al. Does ventricular dyssynchrony on echocardiography
predict response to cardiac resynchronisation therapy? A randomised controlled study.
Heart. Sep 2011;97(17):1410-1416. PMID 21700757
38. Muto C, Solimene F, Gallo P, et al. A randomized study of cardiac resynchronization therapy
defibrillator versus dual-chamber implantable cardioverter-defibrillator in ischemic
cardiomyopathy with narrow QRS: the NARROW-CRT study. Circ Arrhythm Electrophysiol.
Jun 2013;6(3):538-545. PMID 23592833
39. Ruschitzka F, Abraham WT, Singh JP, et al. Cardiac-resynchronization therapy in heart
failure with a narrow QRS complex. New England Journal of Medicine. Oct 10
2013;369(15):1395-1405. PMID 23998714
40. Beshai JF, Grimm RA, Nagueh SF, et al. Cardiac-resynchronization therapy in heart failure
with narrow QRS complexes. N Engl J Med. Dec 13 2007;357(24):2461-2471. PMID
17986493
41. Thibault B, Harel F, Ducharme A, et al. Cardiac Resynchronization Therapy in Patients
With Heart Failure and a QRS Complex <120 Milliseconds: The Evaluation of
Resynchronization Therapy for Heart Failure (LESSER-EARTH) Trial. Circulation. Feb 26
2013;127(8):873-881. PMID 23388213
42. Sipahi I, Carrigan TP, Rowland DY, et al. Impact of QRS duration on clinical event
reduction with cardiac resynchronization therapy: meta-analysis of randomized controlled
trials. Arch Intern Med. Sep 12 2011;171(16):1454-1462. PMID 21670335
43. Bryant AR, Wilton SB, Lai MP, et al. Association between QRS duration and outcome with
cardiac resynchronization therapy: A systematic review and meta-analysis. J Electrocardiol.
Mar 2013;46(2):147-155. PMID 23394690
44. Stavrakis S, Lazzara R, Thadani U. The benefit of cardiac resynchronization therapy and
QRS duration: a meta-analysis. Journal of Cardiovascular Electrophysiology. Feb
2012;23(2):163-168. PMID 21815961
45. Sipahi I, Chou JC, Hyden M, et al. Effect of QRS morphology on clinical event reduction
with cardiac resynchronization therapy: meta-analysis of randomized controlled trials.
American Heart Journal. Feb 2012;163(2):260-267 e263. PMID 22305845
46. Kang SH, Oh IY, Kang DY, et al. Cardiac resynchronization therapy and QRS duration:
systematic review, meta-analysis, and meta-regression. J Korean Med Sci. Jan
2015;30(1):24-33. PMID 25552880
47. Shah RM, Patel D, Molnar J, et al. Cardiac-resynchronization therapy in patients with
systolic heart failure and QRS interval </=130 ms: insights from a meta-analysis. Europace.
Feb 2015;17(2):267-273. PMID 25164431
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MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
48. Zusterzeel R, Selzman KA, Sanders WE, et al. Cardiac resynchronization therapy in women:
US Food and Drug Administration meta-analysis of patient-level data. JAMA Intern Med.
Aug 2014;174(8):1340-1348. PMID 25090172
49. Peterson PN, Greiner MA, Qualls LG, et al. QRS duration, bundle-branch block
morphology, and outcomes among older patients with heart failure receiving cardiac
resynchronization therapy. JAMA. Aug 14 2013;310(6):617-626. PMID 23942680
50. Rogers DP, Lambiase PD, Lowe MD, et al. A randomized double-blind crossover trial of
triventricular versus biventricular pacing in heart failure. Eur J Heart Fail. May
2012;14(5):495-505. PMID 22312038
51. Lenarczyk R, Kowalski O, Sredniawa B, et al. Implantation feasibility, procedure-related
adverse events and lead performance during 1-year follow-up in patients undergoing triplesite cardiac resynchronization therapy: a substudy of TRUST CRT randomized trial. J
Cardiovasc Electrophysiol. Nov 2012;23(11):1228-1236. PMID 22651239
52. Ogano M, Iwasaki YK, Tanabe J, et al. Antiarrhythmic effect of cardiac resynchronization
therapy with triple-site biventricular stimulation. Europace. Oct 2013;15(10):1491-1498.
PMID 23696627
53. Perego GB, Landolina M, Vergara G, et al. Implantable CRT device diagnostics identify
patients with increased risk for heart failure hospitalization. J Interv Card Electrophysiol.
Dec 2008;23(3):235-242. PMID 18810621
54. Abraham WT, Compton S, Haas G, et al. Intrathoracic impedance vs daily weight monitoring
for predicting worsening heart failure events: results of the Fluid Accumulation Status Trial
(FAST). Congest Heart Fail. Mar-Apr 2011;17(2):51-55. PMID 21449992
55. Conraads VM, Tavazzi L, Santini M, et al. Sensitivity and positive predictive value of
implantable intrathoracic impedance monitoring as a predictor of heart failure
hospitalizations: the SENSE-HF trial. European Heart Journal. February 28, 2011 2011.
PMID
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Evaluate Correlation to Symptoms in Patients With Heart Failure. 2010;
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57. Whellan DJ, Ousdigian KT, Al-Khatib SM, et al. Combined Heart Failure Device
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thoracic fluid – Fluid Accumulation Status Trial (FAST). J Card Fail. 2004;10(suppl):251.
59. Gula LJ, Wells GA, Yee R, et al. A novel algorithm to assess risk of heart failure
exacerbation using ICD diagnostics: validation from RAFT. Heart Rhythm. Sep
2014;11(9):1626-1631. PMID 24846373
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MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
60. Sekiguchi Y, Tada H, Yoshida K, et al. Significant increase in the incidence of ventricular
arrhythmic events after an intrathoracic impedance change measured with a cardiac
resynchronization therapy defibrillator. Circ J. 2011;75(11):2614-2620. PMID 21891969
61. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of
heart failure: executive summary: a report of the American College of Cardiology
Foundation/American Heart Association Task Force on practice guidelines. Circulation. Oct
15 2013;128(16):1810-1852. PMID 23741057
62. Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 Guidelines for DeviceBased Therapy of Cardiac Rhythm Abnormalities: a report of the American College of
Cardiology/American Heart Association Task Force on Practice Guidelines (Writing
Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of
Cardiac Pacemakers and Antiarrhythmia Devices): developed in collaboration with the
American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation.
May 27 2008;117(21):e350-408. PMID 18483207
63. Tracy CM, Epstein AE, Darbar D, et al. 2012 ACCF/AHA/HRS Focused Update of the 2008
Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: A Report of the
American College of Cardiology Foundation/American Heart Association Task Force on
Practice Guidelines and the Heart Rhythm Society. Circulation. October 2, 2012
2012;126(14):1784-1800.
64. European Society of C, European Heart Rhythm A, Brignole M, et al. 2013 ESC guidelines
on cardiac pacing and cardiac resynchronization therapy: the task force on cardiac pacing
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2013;15(8):1070-1118. PMID 23801827
65. Heart Failure Society of A, Lindenfeld J, Albert NM, et al. HFSA 2010 Comprehensive Heart
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20610207
Other Sources:
CMS Centers for Medicare and Medicaid Services (CMS) National Coverage Determination
(NCD) 20.8.3 Cardiac Pacemakers: Single Chamber and Dual Chamber Permanent Cardiac
Pacemakers. Effective 8/13/13 CMS [Website]: www.CMS.gov Accessed September 4, 2015.
Novitas Solutions. Local Coverage Article (LCA) A54982 Single Chamber and Dual Chamber
Permanent Pacemakers – Coding and Billing. Effective 5/1/16. [Website]:
https://www.cms.gov/medicare-coverage-database/details/articledetails.aspx?articleId=54982&ver=6&LCDId=35070&name=314*1&UpdatePeriod=672
&bc=AQAAEAAAAAAAAA%3d%3d&. Accessed April 15, 2016.
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MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
X. POLICY HISTORY
TOP
MP 2.007 CAC 12/2/03
CAC 1/27/04
CAC 10/26/04
CAC 6/28/05
CAC 3/28/06
CAC 3/27/07
CAC 5/27/08
CAC 3/31/09 Consensus
CAC 3/30/10 Minor revision. Statement added that Biventricular pacemakers with or
without an accompanying implantable cardiac defibrillator are considered investigational
as a treatment of NYHA class I or II heart failure.
CAC 11/22/11 Minor revision. Biventricular pacemakers now considered medically
necessary for NYHA class II indications, remaining investigational for class I. The term
“congestive” in reference to the use of biventricular pacemakers was removed.
CAC 10/30/12 BCBSA criteria adopted for biventricular pacemakers. For this
review, a new investigational indication was added for the use of biventricular
pacemakers for the treatment for heart failure in patients with atrial fibrillation.
Policy title revised to “Biventricular Pacemakers (Cardiac Resynchronization
Therapy) for the Treatment of Heart Failure”. The indication as a treatment for
heart failure in patients with atrial fibrillation is considered investigational unless
through medications or ablation, the patient would be expected to be pacemaker
dependent was added to the policy. Rationale for this use of CRT in patients with
atrial fibrillation were also added to the policy background. Criteria for temporary
and permanent pacemakers and cardiac pacemaker monitoring removed from the
policy. FEP variation revised for biventricular pacemakers to refer to the FEP
policy.
Codes reviewed 9/18/12 klr
CAC 11/26/13 Additional investigational policy statement added for triple-site
(triventricular) CRT. Added Rationale section. All rationale information now
contained in that section. Deleted Medicare variation addressing NCD 220.2
Magnetic Resonance Imaging and L30529 - Cardiac Rhythm Device Evaluation.
The CBC policy does not address services described within these documents.
Added reference to NCD 20.8.3 in Medicare variation.
CAC 11/25/14 Consensus review. References and rationale updated. No changes
to the policy statements. Coding reviewed, no changes.
CAC 11/24/15. Minor review. For NYHA Class II, III or IV - changed criteria
from “QRS duration of  (greater than or equal to) 120-130 msec” to “Either left
bundle branch block or QRS duration ≥150 ms” Also changed "Patients treated
with a stable and maximal pharmacological medical regimen prior to implant, such
Page 34
MEDICAL POLICY
POLICY TITLE
BIVENTRICULAR PACEMAKERS (CARDIAC RESYNCHRONIZATION
THERAPY) FOR THE TREATMENT OF HEART FAILURE
POLICY NUMBER
MP-2.007
as an angiotensin converting enzyme (ACE) inhibitor (or an angiotensin receptor
blocker) and a beta blocker, digoxin, and/or diuretics" to "Patients treated with
guideline-directed medical therapy. Link added to 2013 American College of
Cardiology Foundation/American Heart Association guidelines for the management
of heart failure. Policy statement added that CRT in patients with heart failure and
AV block may be considered medically necessary with criteria. Rationale and
references updated. Coding updated.
5/1/16 Administrative change. Added Medicare variation to reference LCA
A54982 Single Chamber and Dual Chamber Permanent Cardiac Pacemakers –
Coding and Billing
Top
Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance Company®,
Capital Advantage Assurance Company® and Keystone Health Plan® Central. Independent licensees of the BlueCross BlueShield Association.
Communications issued by Capital BlueCross in its capacity as administrator of programs and provider relations for all companies.
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