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Transcript
Medical Policy
Biventricular Pacemakers - Cardiac Resynchronization Therapy for
the Treatment of Heart Failure
Table of Contents

Policy: Commercial

Coding Information

Information Pertaining to All Policies

Policy: Medicare

Description

References

Authorization Information

Policy History
Policy Number: 101
BCBSA Reference Number: 2.02.10
Related Policies


Implantable Cardioverter Defibrillator (ICD), #070
Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting, #287
Policy
Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members
Biventricular pacemakers with or without an accompanying implantable cardiac defibrillator (i.e., a
combined biventricular pacemaker/ICD) may be MEDICALLY NECESSARY to treat heart failure in
patients who have the following conditions:
 New York Heart Association class III or IV
o Left ventricular ejection fraction ≤35%, AND
o Sinus rhythm, AND
o QRS duration of ≥120–130* msec, AND
o Patients treated with a stable pharmacological medical regimen prior to implant, such as an
angiotensin-converting enzyme (ACE) inhibitor (or an angiotensin receptor blocker) and a beta
blocker (or angiotensin receptor blocker), digoxin, and/or diuretics.
 New York Heart Association class II
o Left ventricular ejection fraction ≤30%, AND
o Sinus rhythm, AND
o QRS duration of ≥120–130* msec, AND
o Patients treated with a stable pharmacological medical regimen prior to implant, such as an
angiotensin-converting enzyme (ACE) inhibitor (or an angiotensin receptor blocker) and a beta
blocker (or angiotensin receptor blocker), digoxin, and/or diuretics.
Biventricular pacemakers with or without an accompanying implantable cardiac defibrillator (i.e., a
combined biventricular pacemaker/ICD) to treat NYHA class I heart failure are INVESTIGATIONAL.
Biventricular pacemakers, with or without an accompanying implantable cardiac defibrillator (i.e., a
combined biventricular pacemaker/ICD) as a treatment for heart failure in patients with atrial fibrillation,
are INVESTIGATIONAL.
1
Intrathoracic fluid monitoring sensor as a component of a biventricular pacemaker is INVESTIGATIONAL.
Triple-site (triventricular) CRT, using an additional pacing lead, is INVESTIGATIONAL.
Prior Authorization Information
Pre-service approval is required for all inpatient services for all products.
See below for situations where prior authorization may be required or may not be required for outpatient
services.
Yes indicates that prior authorization is required.
No indicates that prior authorization is not required.
Outpatient
No
Commercial Managed Care (HMO and POS)
No
Commercial PPO and Indemnity
SM
No
Medicare HMO Blue
SM
No
Medicare PPO Blue
CPT Codes / HCPCS Codes / ICD-9 Codes
The following codes are included below for informational purposes. Inclusion or exclusion of a code does
not constitute or imply member coverage or provider reimbursement. Please refer to the member’s
contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an
individual member. A draft of future ICD-10 Coding related to this document, as it might look today, is
included below for your reference.
Providers should report all services using the most up-to-date industry-standard procedure, revenue, and
diagnosis codes, including modifiers where applicable.
CPT Codes
CPT Codes
Description
33208
Insertion of new or replacement of permanent pacemaker with transvenous
electrode(s); atrial and ventricular
Insertion or replacement of temporary transvenous dual chamber pacing electrodes
(separate procedure)
Insertion or replacement of pacemaker pulse generator only; with existing dual leads
Upgrade of implanted pacemaker system, conversion of single chamber system to dual
chamber system (includes removal of previously placed pulse generator, testing of
existing lead, insertion of new lead, insertion of new pulse generator)
Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, with
attachment to previously placed pacemaker or pacing cardioverter-defibrillator pulse
generator (including revision of pocket, removal, insertion, and/or replacement of
existing generator)
Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time
of insertion of pacing cardioverter-defibrillator or pacemaker pulse generator (including
upgrade to dual chamber system and pocket revision) (List separately in addition to
code for primary procedure)
33211
33213
33214
33224
33225
HCPCS Codes
HCPCS
Codes
Description
C1785
C1779
C1900
Pacemaker, dual chamber, rate-responsive (implantable)
Lead, pacemaker, transvenous VDD single pass
Lead, left ventricular coronary venous system
2
ICD-9 Diagnosis Codes
ICD-9-CM
diagnosis
codes:
428.0
428.1
428.20
428.21
428.22
428.23
428.33
428.40
428.41
428.42
428.43
428.9
Code Description
Congestive heart failure, unspecified
Left heart failure
Systolic heart failure, unspecified
Acute systolic heart failure
Chronic systolic heart failure
Acute on chronic systolic heart failure
Acute on chronic diastolic heart failure
Combined systolic and diastolic heart failure, unspecified
Acute combined systolic and diastolic heart failure
Chronic combined systolic and diastolic heart failure
Acute on chronic combined systolic and diastolic heart failure
Heart failure, unspecified
ICD-9 Procedure Codes
When the following ICD 9 procedure codes are associated with the service(s) described in this document
coverage for the service(s) is aligned with the policy statement.
ICD-9-CM
procedure
codes:
Code Description
Implantation of cardiac resynchronization pacemaker without mention of defibrillation,
00.50
total system [CRT-P]
00.51
Implantation of cardiac resynchronization defibrillator, total system [CRT-D]
Implantation or replacement of transvenous lead [electrode] into left ventricular
00.52
coronary venous system
Implantation or replacement of cardiac resynchronization pacemaker pulse generator
00.53
only [CRT-P]
Implantation or replacement of cardiac resynchronization defibrillator pulse generator
00.54
only [CRT-D]
ICD-10 Diagnosis Codes
ICD-10-CM
Diagnosis
codes:
I50.20
I50.1
I50.21
I50.22
I50.23
I50.33
I50.40
I50.41
I50.42
I50.43
I50.9
Code Description
Unspecified systolic (congestive) heart failure
Left ventricular failure
Acute systolic (congestive) heart failure
Chronic systolic (congestive) heart failure
Acute on chronic systolic (congestive) heart failure
Acute on chronic diastolic (congestive) heart failure
Unspecified combined systolic (congestive) and diastolic (congestive) heart failure
Acute combined systolic (congestive) and diastolic (congestive) heart failure
Chronic combined systolic (congestive) and diastolic (congestive) heart failure
Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure
Heart failure, unspecified
ICD-10 Procedure Codes
ICD-10-PCS
procedure
Code Description
3
codes:
02H40JZ
02H43JZ
02H43KZ
02H43MZ
02H44JZ
02H60JZ
02H63JZ
02H64JZ
02HK0JZ
02HK0KZ
02HK3JZ
02HK3KZ
02HK4JZ
02HK4KZ
02HL0JZ
02HL0KZ
02HL3JZ
02HL3KZ
02HL4JZ
02HL4KZ
02PA0MZ
02PA3MZ
02PA4MZ
0JH607Z
0JH609Z
0JH637Z
0JH639Z
0JH807Z
0JH809Z
0JH837Z
0JH839Z
0JPT0PZ
0JPT3PZ
Insertion of Pacemaker Lead into Coronary Vein, Open Approach
Insertion of Pacemaker Lead into Coronary Vein, Percutaneous Approach
Insertion of Defibrillator Lead into Coronary Vein, Percutaneous Approach
Insertion of Cardiac Lead into Coronary Vein, Percutaneous Approach
Insertion of Pacemaker Lead into Coronary Vein, Percutaneous Endoscopic Approach
Insertion of Pacemaker Lead into Right Atrium, Open Approach
Insertion of Pacemaker Lead into Right Atrium, Percutaneous Approach
Insertion of Pacemaker Lead into Right Atrium, Percutaneous Endoscopic Approach
Insertion of Pacemaker Lead into Right Ventricle, Open Approach
Insertion of Defibrillator Lead into Right Ventricle, Open Approach
Insertion of Pacemaker Lead into Right Ventricle, Percutaneous Approach
Insertion of Defibrillator Lead into Right Ventricle, Percutaneous Approach
Insertion of Pacemaker Lead into Right Ventricle, Percutaneous Endoscopic Approach
Insertion of Defibrillator Lead into Right Ventricle, Percutaneous Endoscopic Approach
Insertion of Pacemaker Lead into Left Ventricle, Open Approach
Insertion of Defibrillator Lead into Left Ventricle, Open Approach
Insertion of Pacemaker Lead into Left Ventricle, Percutaneous Approach
Insertion of Defibrillator Lead into Left Ventricle, Percutaneous Approach
Insertion of Pacemaker Lead into Left Ventricle, Percutaneous Endoscopic Approach
Insertion of Defibrillator Lead into Left Ventricle, Percutaneous Endoscopic Approach
Removal of Cardiac Lead from Heart, Open Approach
Removal of Cardiac Lead from Heart, Percutaneous Approach
Removal of Cardiac Lead from Heart, Percutaneous Endoscopic Approach
Insertion of Cardiac Resynchronization Pacemaker Pulse Generator into Chest
Subcutaneous Tissue and Fascia, Open Approach
Insertion of Cardiac Resynchronization Defibrillator Pulse Generator into Chest
Subcutaneous Tissue and Fascia, Open Approach
Insertion of Cardiac Resynchronization Pacemaker Pulse Generator into Chest
Subcutaneous Tissue and Fascia, Percutaneous Approach
Insertion of Cardiac Resynchronization Defibrillator Pulse Generator into Chest
Subcutaneous Tissue and Fascia, Percutaneous Approach
Insertion of Cardiac Resynchronization Pacemaker Pulse Generator into Abdomen
Subcutaneous Tissue and Fascia, Open Approach
Insertion of Cardiac Resynchronization Defibrillator Pulse Generator into Abdomen
Subcutaneous Tissue and Fascia, Open Approach
Insertion of Cardiac Resynchronization Pacemaker Pulse Generator into Abdomen
Subcutaneous Tissue and Fascia, Percutaneous Approach
Insertion of Cardiac Resynchronization Defibrillator Pulse Generator into Abdomen
Subcutaneous Tissue and Fascia, Percutaneous Approach
Removal of Cardiac Rhythm Related Device from Trunk Subcutaneous Tissue and
Fascia, Open Approach
Removal of Cardiac Rhythm Related Device from Trunk Subcutaneous Tissue and
Fascia, Percutaneous Approach
Description
Cardiac resynchronization therapy (CRT), which consists of synchronized pacing of the left and right
ventricles, is intended to treat patients with heart failure and dyssynchronous ventricular contractions.
Treatment involves placement of a device that paces both ventricles and which coordinates ventricular
pacing to maximize cardiac pumping function and left ventricular ejection fraction (LVEF).
It is estimated that 20–30% 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
4
electrocardiogram (ECG). This abnormality appears to be associated with increased morbidity and
mortality. Biventricular pacemakers using 3 leads (1 in the right atrium and 1 in each ventricle) have
been investigated as a technique to coordinate the contraction of the ventricles, thus improving patients’
hemodynamic status. Two strategies are being explored: incorporating biventricular pacing into
automatic implantable cardiac defibrillators and the development of stand-alone biventricular
pacemakers.
One stand-alone biventricular pacemaker (InSync® Biventricular Pacing System, Medtronic) has
received approval by the U.S. Food and Drug Administration (FDA) for the treatment of patients with
New York Heart Association (NYHA) class III or IV heart failure, on a stable pharmacologic regimen,
who also have a QRS duration of 130 msec or longer and a left ventricular ejection fraction (LVEF) of
35% or less. Biventricular pacemakers have also been combined with automatic implantable cardiac
defibrillators (ICDs). 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 msec or longer (120 msec or longer
for the Guidant device), and remain symptomatic despite a stable, optimal heart failure drug therapy.
In September 2010, the FDA expanded the indications for cardiac resynchronization therapy (CRT) to
include patients with class I and II heart failure. In addition to NYHA class I/II heart failure, indications for
CRT in mild heart failure include a LVEF of less than 30% and a QRS duration of 130 msec or greater.
In 2005, the InSync Sentry system received FDA approval through the supplemental premarket approval
(PMA) 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 to 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.
Summary
Evidence from clinical trials and systematic reviews supports the benefit of CRT treatment for patients
with 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 who have an ejection fraction <35%, sinus rhythm, a QRS duration of at
least 120 msec, and who are treated with an optimal pharmacologic regimen.
For patients with milder heart failure, RCT evidence from at least one 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 for class II patients, but no studies provide
evidence of treatment benefit on functional status or QOL outcomes. Despite the lower level of evidence
available for mild compared to 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.
Treatment of patients with atrial fibrillation 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 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
5
mixed as to whether patients with atrial fibrillation should be treated with CRT. Therefore, CRT remains
investigational for patients with atrial fibrillation.
The optimal selection of patients for CRT treatment remains uncertain. Accumulating evidence indicates
that benefit is concentrated in patients with a QRS duration of greater than 150 msec. This factor offers
a potential method to better select patients for CRT and potentially avoid treatment in patients who will
not benefit. Clinical input in 2012 demonstrated support for continued use of QRS threshold of 120
msec, rather than restricting treatment to patients with QRS greater than 150 msec. Other factors for
selecting patients, such as ventricular dyssynchrony on echocardiography, have not been shown to be
good discriminators of responders versus non-responders.
Policy History
Date
Action
7/2014
5/2014
4/2014
10/2013
New references added from BCBSA National medical policy.
Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/2015.
Coding information clarified
BCBSA National medical policy review.
New investigational indications described. Effective 10/1/2013.
BCBSA National medical policy review.
New investigational indications described. Cardiac Resynchronization Therapy” added
to policy title. Effective 3/1/2013
Medical policy ICD 10 remediation: Formatting, editing and coding updates.
No changes to policy statements.
BCBSA National medical policy review.
Changes to policy statements.
Medical Policy Group - Cardiology and Pulmonology.
No changes to policy statements.
New policy, effective 6/2009, describing covered and non-covered indications.
3/2013
11/20114/2012
12/1/2011
4/2011
6/2009
Information Pertaining to All Blue Cross Blue Shield Medical Policies
Click on any of the following terms to access the relevant information:
Medical Policy Terms of Use
Managed Care Guidelines
Indemnity/PPO Guidelines
Clinical Exception Process
Medical Technology Assessment Guidelines
References
1. FDA. Summary of Safety and Effectiveness Data: Tupos LV/ATx CRT-D, Kronos LV-T CRT-D.
2006. Available online at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050023b.pdf. Last
accessed March, 2014.
2. FDA. Approval Order: Biotronic PMA P050023. 2013. Available online at:
http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050023S058A.pdf. Last accessed March, 2014.
3. 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 2005; 46(6):e1-82.
4. Cardiac resynchronization therapy for mild congestive heart failure. Blue Cross and Blue Shield
Association Technology Evaluation Center TEC Assessment Program 2009; 24(8).
5. 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 2004; 350(21):2140-50.
6. McAlister FA, Ezekowitz JA, Wiebe N et al. Systematic review: cardiac resynchronization in patients
with symptomatic heart failure. Ann Intern Med 2004; 141(5):381-90.
6
7. Moss AJ, Hall WJ, Cannom DS et al. Cardiac-resynchronization therapy for the prevention of heartfailure events. N Engl J Med 2009; 361(14):1329-38.
8. 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 2011; 58(7):729-37.
9. Tang AS, Wells GA, Talajic M et al. Cardiac-resynchronization therapy for mild-to-moderate heart
failure. N Engl J Med 2010; 363(25):2385-95.
10. 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 2008; 52(23):1834-43.
11. 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 2013; 34(33):2592-9.
12. 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 cardioverterdefibrillator, and mildly symptomatic chronic heart failure. Circulation 2004; 110(18):2864-8.
13. 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 2011; 58(9):935-41.
14. Al-Majed NS, McAlister FA, Bakal JA et al. Meta-analysis: cardiac resynchronization therapy for
patients with less symptomatic heart failure. Ann Intern Med 2011; 154(6):401-12.
15. Bertoldi EG, Polanczyk CA, Cunha V et al. Mortality reduction of cardiac resynchronization and
implantable cardioverter-defibrillator therapy in heart failure: an updated meta-analysis. Does recent
evidence change the standard of care? J Card Fail 2011; 17(10):860-6.
16. 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 2011;
8(7):1083-7.
17. 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 2011;
25(4):331-40.
18. Wells G, Parkash R, Healey JS et al. Cardiac resynchronization therapy: a meta-analysis of
randomized controlled trials. CMAJ 2011; 183(4):421-9.
19. 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 meta-analysis of 5674
patients. Europace 2013; 15(7):992-1001.
20. 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 2011; 58(10):995-1000.
21. 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 2011;
32(19):2420-9.
22. 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 2012; 5(5):566-70.
23. 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
2011; 8(7):1088-94.
24. 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 2012; 59(8):719-26.
25. Eisen A, Nevzorov R, Goldenberg G et al. Cardiac resynchronization therapy in patients with atrial
fibrillation: a 2-year follow-up study. Pacing and Clinical Electrophysiology 2013; 36(7):872-7.
26. Yu CM, Abraham WT, Bax J et al. Predictors of response to cardiac resynchronization therapy
(PROSPECT)--study design. Am Heart J 2005; 149(4):600-5.
27. Chung ES, Leon AR, Tavazzi L et al. Results of the Predictors of Response to CRT (PROSPECT)
trial. Circulation 2008; 117(20):2608-16.
7
28. Hawkins NM, Petrie MC, MacDonald MR et al. Selecting patients for cardiac resynchronization
therapy: electrical or mechanical dyssynchrony? Eur Heart J 2006; 27(11):1270-81.
29. Diab IG, Hunter RJ, Kamdar R et al. Does ventricular dyssynchrony on echocardiography predict
response to cardiac resynchronisation therapy? A randomised controlled study. Heart 2011;
97(17):1410-6.
30. 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 2013; 6(3):538-45.
31. Ruschitzka F, Abraham WT, Singh JP et al. Cardiac-resynchronization therapy in heart failure with a
narrow QRS complex. New England Journal of Medicine 2013; 369(15):1395-405.
32. Beshai JF, Grimm RA, Nagueh SF et al. Cardiac-resynchronization therapy in heart failure with
narrow QRS complexes. N Engl J Med 2007; 357(24):2461-71.
33. 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 2013; 127(8):873-81.
34. 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
2011; 171(16):1454-62.
35. Bryant AR, Wilton SB, Lai MP et al. Association between QRS duration and outcome with cardiac
resynchronization therapy: A systematic review and meta-analysis. Journal of Electrocardiology
2013; 46(2):147-55.
36. Stavrakis S, Lazzara R, Thadani U. The benefit of cardiac resynchronization therapy and QRS
duration: a meta-analysis. Journal of Cardiovascular Electrophysiology 2012; 23(2):163-8.
37. 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
2012; 163(2):260-7 e3.
38. 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
2013; 310(6):617-26.
39. 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 2012; 14(5):495-505.
40. 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 triple-site cardiac
resynchronization therapy: a substudy of TRUST CRT randomized trial. Journal of Cardiovascular
Electrophysiology 2012; 23(11):1228-36.
41. Ogano M, Iwasaki YK, Tanabe J et al. Antiarrhythmic effect of cardiac resynchronization therapy
with triple-site biventricular stimulation. Europace 2013; 15(10):1491-8.
42. 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 2008; 23(3):235-42.
43. 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):2614-20.
44. Brachmann J, Bohm M, Rybak K et al. Fluid status monitoring with a wireless network to reduce
cardiovascular-related hospitalizations and mortality in heart failure: rationale and design of the
OptiLink HF Study (Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring
and CareLink). Eur J Heart Fail 2011; 13(7):796-804.
45. Foreman B FR, Odryzynski NI et al. 10(suppl):abstract 251. Intra-thoracic impedance: A surrogate
measure of thoracic fluid – Fluid Accumulation Status Trial (FAST). J Card Fail 2004; 10(suppl):251.
46. 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 2011; 17(2):51-5.
47. 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 2011.
8
48. site. Cgw. PARTNERS HF: Program to Access and Review Trending Information and Evaluate
Correlation to Symptoms in Patients With Heart Failure. . 2010. Available online at:
http://clinicaltrials.gov/ct2/show/results/NCT00279955. Last accessed February 2010.
49. Whellan DJ, Ousdigian KT, Al-Khatib SM et al. Combined Heart Failure Device Diagnostics Identify
Patients at Higher Risk of Subsequent Heart Failure HospitalizationsResults From PARTNERS HF
(Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in
Patients With Heart Failure) Study. Journal of the American College of Cardiology 2010;
55(17):1803-10.
50. Epstein AE, DiMarco JP, Ellenbogen KA et al. ACC/AHA/HRS 2008 Guidelines for Device-Based
Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American
Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the
ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and
Antiarrhythmia Devices): developed in collaboration with the American Association for Thoracic
Surgery and Society of Thoracic Surgeons. Circulation 2008; 117(21):e350-408.
51. 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 2012; 126(14):1784-800.
52. 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 and
resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration
with the European Heart Rhythm Association (EHRA). Europace 2013; 15(8):1070-118.
53. Heart Failure Society of A, Lindenfeld J, Albert NM et al. HFSA 2010 Comprehensive Heart Failure
Practice Guideline. Journal of Cardiac Failure 2010; 16(6):e1-194.
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