Acute Lead Dislodgements in NCDR® ICD Registry™ Patients
Alan Cheng, MD, Yongfei Wang, MS, Jeptha P. Curtis, MD, Paul D. Varosy, MD
Johns Hopkins University School of MedicineYale University School of Medicine
University of Colorado, Denver School of MedicineNovember 16, 2009
Disclosures• A.C.
– Boston Scientific (research, honorarium)
– Medtronic (honorarium)
• J.P.C.
– Medtronic (ownership)
• P.D.V.
– Boston Scientific (honorarium)
Background• Acute lead dislodgements are common
adverse events
• Current estimates range between 1.8-8%
• Many dislodgements occur early after implant
• Little is known regarding predisposing factors and sequelae related to lead dislodgments
Methods• NCDR® ICD Registry™ includes Medicaire
beneficiaries undergoing ICD/CRT implants
• Entries from 4/2006—09/2008 screened
• Previous ICDs excluded
• 1° endpoint: acute lead dislodgements
• 2° endpoint: advanced adverse events
Methods (cont’d)• Variables used in ICD Registry™ v1.08
• X2 and t testing
• Hierarchical logistic regression models generated
• P<0.05 considered significant
• Missing data <0.5%. Dummy variables imputed to avoid case-wise deletion
Results
• 226,764 were used in the analysis
– 35.2% analyzed were CRT-D systems
• Acute lead dislodgements occurred with a frequency of 1.1%
Results: Entire CohortAge 67.5 years
Females 27%
Non White 23.7%
Ischemic 65.2%
Diabetes 37.2%
Hypertension 75.2%
ESRD 4.2%
Variable Acute Dislodgement No Acute Dislodgement P Value
Age 68.5 ± 12.7 yrs 67.5 ± 13 yrs 0.0002
Female 29.9% 27.0% <0.002
NYHA Class <0.0001
Class I 9.3% 12.4%
Class II 26.3% 35.8%
Class III 58.1% 47.4%
Class IV 6.5% 4.4%
Variable Acute Dislodgement No Dislodgement P Value
Atrial fibrillation 35.9% 31.3% <0.0001
Ischemic CM 60.3% 65.3% <0.0001
Prior pacemaker 14.1% 11.2% <0.0001
CVA 16.7% 14.5% 0.0016
Lung disease 25.6% 22.8% 0.0007
Variable Acute Dislodgement No Dislodgement P Value
Ejection fraction 26.8 ± 10.5% 27.5 ± 10.7% 0.0026
QRS Duration 134.6 ± 35msec 125.3 ± 34msec <0.0001
Biventricular 54.6% 35.0% <0.0001
Epicardial lead 7.4% 3.8% <0.0001
Variable Dislodgements No Dislodgements P Value
Implant Volume 135 ± 97 144 ± 101 <0.0001
Teaching Hospital 55.2% 54.7% 0.65
Physician Training 0.007
BC/BE EP 80.9% 82.3%
HRS Guidelines 11.2% 9.7%
Surgery Boards 2.8% 2.0%
Variable Acute Dislodgements No Dislodgements P Value
Length of Stay 6.02 days 4.51 days <0.002
Drug Reaction 0.32% 0.09% <0.0001
Sup. Phlebitis 0.16% 0.04% <0.004
Hematoma 4.38% 0.97% <0.0001
Infection 0.16% 0.03% <0.0001
Peri. embolus 0.20% 0.03% <0.0001
Variable Acute Dislodgements No Dislodgements P Value
Cardiac Arrest 1.10% 0.31% <0.0001
Cardiac Perforation
0.89% 0.07% <0.0001
Pneumothorax 1.38% 0.48% <0.0001
Hemothorax 0.24% 0.09% 0.0171
In hospital death 1.05% 0.41% <0.0001
Endpoint Odds Ratio* Confidence Intervals
Combined Events 3.4 2.8—4.2(Cardiac arrest, Cardiac
Perforation, Pneumothorax, Cardiac Tamponade,
Infection)
In hospital Death 2.1 1.5—2.9
*Adjusted for age, gender, race, CHF, atrial fibrillation, cardiomyopathy etiology, CVA, lung disease, renal failure, ejection fraction, QRS duration, physician implant volume, hospital volume
*Adjusted for age, gender, race, CHF, atrial fibrillation, cardiomyopathy etiology, CVA, lung disease, renal failure, ejection fraction, QRS duration, physician implant volume, hospital volume
Conclusions
• Acute lead dislodgements—most common adverse events (1.1%)
• Individuals with greater comorbidities at greater risk
• Formalized EP training associated with fewer events
Conclusions (cont’d)
• Downstream adverse events occur 10.9%
• Lead dislodgments increase risk for major complications and in hospital death after adjustment for confounders