Is Upgrade to CRT Device More Likely in Pacemaker or Defibrillator Patients?
Insights from the REPLACE Registry
Behzad B. Pavri M.D.1, Richard Holcomb Ph.D.2, Marye J. Gleva, M.D.3, Mina Chung M.D.4, Theofanie Mela M.D.5, Ventakeshwar Gottipaty M.D.6,
Timothy Shinn M.D.7, Richard Borge M.D.8, Kevin Mitchell R.N.9, and Jeanne E. Poole M.D.10
1Thomas
Jefferson University Hospital, 2Private practice, Minneapolis, MN, 3Washington University School of Medicine, 4Cleveland Clinic, 5Massachussetes General Hospital, 6South Carolina Heart
Center, 7Michigan Heart, PC, 8Abington Medical Specialists, 9BIOTRONIK, Inc., and 10University of Washington School of Medicine
BACKGROUND
 Pacemaker (PM) and defibrillators (ICD) patients often
study that determined 6-month complication rates after
PM or ICD generator replacement in 1744 patients.
Results were previously reported*
 This analysis focuses on all 407 REPLACE patients with
a plan to upgrade to a CRT device
90
80
70
Patients (%)
 The REPLACE Registry was a prospective, multicenter
 Median time to upgrade was 3.6 yrs, and was the
100
undergo upgrade from single or dual chamber systems to
cardiac resynchronization (CRT) systems
Early Upgrade
(≤2 yrs)
60
50
40
n = 117
30
20
10
time to CRT upgrade for REPLACE Registry patients
n = 49
n = 59
Existing PM*
Existing ICD*
* One patient with a PM and 2 patients with an ICD had unknown times to upgrade.
TABLE 1. SELECTED BASELINE VARIABLES
METHODS
 Patients were grouped by:
 Existing device type: PM or ICD
 Time to upgrade after original implant was defined as:
Early (≤2 yrs) or Late (>2 yrs)
 The Charlson Co-morbidity Index (CCI) was collected on
all patients in the REPLACE Registry
 Statistical Methods:
 Student’s t test for continuous variables
 Fisher’s Exact or Chi Square Test for categorical
variables
 Multivariate logistic regression
FIGURE 1. EXISTING DEVICES
Existing PM
(≤2 yrs vs. >2 yrs)
Existing ICD
(≤2 yrs vs. >2 yrs)
73.27 vs. 73.00; p=NS
65.31 vs. 68.75; p=NS
Gender, % male
75.5 vs. 77.8; p=NS
79.7 vs. 87.7; p=NS
Pacer dependent, %
46.9 vs. 45.3; p=NS
16.9 vs. 17.3; p=NS
p=NS*
P=NS†
Ejection Fraction, %
26.80 vs. 28.86; p=NS
25.02 vs. 23.90; p=NS
Admit HF (<12 mo), % yes
40.8 vs. 23.9; p=0.039
57.6 vs. 35.8; p=0.004
Hx CABG/Valve Surgery, %
42.9 vs. 47.9; p=NS
37.3 vs. 48.0; p=NS
CCI, score
2.55 vs. 2.67; p=NS
3.31 vs. 2.69; p=0.046
Practice Type, % private
63.3 vs. 57.3; p=NS
52.5 vs. 55.3; p=NS
Antiarrhythmic Drug, %
16.3 vs. 11.1; p=NS
37.3 vs. 36.3; p=NS
ACE Inhibitor, %
53.1 vs. 56.4; p=NS
72.9 vs. 61.5; p=NS
Beta Blockers, %
93.9 vs. 88.9; p=NS
88.1 vs. 80.4; p=NS
28.6 vs. 14.5; p=0.048
13.6 vs. 16.2; p=NS
14.3 vs. 7.7; p=NS
6.8 vs. 3.4; p=NS
Age, yrs
NYHA Class I to IV, distribution
Angiotensin Blocker, %
Calcium Channel Blocker, %
Total existing
ICD = 240
n = 179
Late Upgrade
(>2 yrs)
0
 Objective: To examine the clinical characteristics and
Total existing
PM = 167
RESULTS SUMMARY
FIGURE 2. TIME TO UPGRADE BY DEVICE
Pacer-Single
Pacer-Dual
* Existing PM, %: Class I, 2.0 vs. 1.7; Class II, 8.2 vs. 12.8; Class III, 79.6 vs. 72.6; Class IV, 2.0 vs. 3.4.
† Existing ICD, %: Class I, 3.4 vs. 1.7; Class II, 11.9 vs. 10.1; Class III, 71.2 vs. 81.0; Class IV, 10.2 vs. 3.4.
same for PM and ICD patients (Figure 2)
 Baseline clinical variables including the CCI are in
Table 1. Only 2 variables were statistically significant in
univariate analysis:
 Admission for heart failure in the 12 mo. prior to
CRT upgrade was more common in early vs. late
upgrade pts:
 PM (41% vs. 24%, P=0.039)
 ICD (58% vs. 36%, P=0.004)
 CCI was higher in early vs. late upgrade pts with an
ICD (3.3 vs. 2.7, P=0.046)
 Stepwise linear regression confirmed admission for
heart failure in the 12 mo. prior to CRT upgrade as
a significant predictor of early upgrade in pts with both
device types:
 PM: OR=2.18, P=0.034
 ICD: OR=2.44, P=0.004
CONCLUSIONS
 One-fourth of REPLACE Registry CRT upgrade
patients had the procedure early (≤2 years) of their
existing device implant
 No meaningful difference was observed in proportions
of patients with PMs or ICDs requiring early upgrade to
CRT
 The most significant predictor of early upgrade for both
PM and ICD patients was admission for heart failure in
the 12 months prior to the upgrade to CRT
 Higher CCI in ICD patients influenced the probability of
early upgrade
CRT-Pacer
ICD-Single
ICD-Dual
CRT-ICD
* Poole JE, Gleva M, Mela T, Chung M, Uslan D, Borge R, Gottipaty V, Shinn T,
Dan D, et al. Complication Rates Associated with Pacemaker and Implantable
Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures:
Results from the REPLACE Registry. Circulation 2010;122:1553-61.
Declaration of Interest:
REPLACE was sponsored by BIOTRONIK.
B.B. Pavri
BIOTORNIK; Medtronic, Inc.; Boston Scientific Corp.; St. Jude Medical
R.G. Holcomb
BIOTRONIK; Medtronic, Inc.; Boston Scientific Corp.
M.J. Gleva
BIOTRONIK
M. Chung
BIOTORNIK; Medtronic, Inc.; Boston Scientific Corp.; St. Jude Medical
T. Mela
BIOTRONIK
V. GottipatyBIOTRONIK
T. Shinn
BIOTRONIK
R. Borge
BIOTRONIK; Boston Scientific Corp.; Medtronic, Inc.; St. Jude Medical
K. Mitchell
BIOTRONIK
J.E. Poole
BIOTRONIK; Boston Scientific Corp.; Medtronic, Inc.; St. Jude Medical; Cardiac Science Corp.; Sanofi Aventis