1. 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 Medicine Yale University School of Medicine University of Colorado, Denver School of Medicine November 16, 2009

2. Disclosures A.C. –Boston Scientific (research, honorarium) –Medtronic (honorarium) J.P.C. –Medtronic (ownership) P.D.V. –Boston Scientific (honorarium)

3. 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

4. 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

5. Methods (cont’d) Variables used in ICD Registry™ v1.08 X 2 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

6. 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%

7. Results: Entire Cohort Age67.5 years Females27% Non White23.7% Ischemic65.2% Diabetes37.2% Hypertension75.2% ESRD4.2%

8. VariableAcute DislodgementNo Acute DislodgementP Value Age 68.5 ± 12.7 yrs67.5 ± 13 yrs 0.0002 Female29.9%27.0%<0.002 NYHA Class<0.0001 Class I9.3%12.4% Class II26.3%35.8% Class III58.1%47.4% Class IV6.5%4.4%

9. VariableAcute DislodgementNo DislodgementP Value Atrial fibrillation35.9%31.3%<0.0001 Ischemic CM60.3%65.3%<0.0001 Prior pacemaker14.1%11.2%<0.0001 CVA16.7%14.5%0.0016 Lung disease25.6%22.8%0.0007

10. VariableAcute DislodgementNo DislodgementP Value Ejection fraction 26.8 ± 10.5%27.5 ± 10.7% 0.0026 QRS Duration 134.6 ± 35msec125.3 ± 34msec <0.0001 Biventricular54.6%35.0%<0.0001 Epicardial lead7.4%3.8%<0.0001

11. VariableDislodgementsNo DislodgementsP Value Implant Volume 135 ± 97144 ± 101 <0.0001 Teaching Hospital55.2%54.7%0.65 Physician Training0.007 BC/BE EP80.9%82.3% HRS Guidelines11.2%9.7% Surgery Boards2.8%2.0%

12. VariableAcute DislodgementsNo DislodgementsP Value Length of Stay6.02 days4.51 days<0.002 Drug Reaction0.32%0.09%<0.0001 Sup. Phlebitis0.16%0.04%<0.004 Hematoma4.38%0.97%<0.0001 Infection0.16%0.03%<0.0001 Peri. embolus0.20%0.03%<0.0001

13. VariableAcute DislodgementsNo DislodgementsP Value Cardiac Arrest1.10%0.31%<0.0001 Cardiac Perforation 0.89%0.07%<0.0001 Pneumothorax1.38%0.48%<0.0001 Hemothorax0.24%0.09%0.0171 In hospital death1.05%0.41%<0.0001

14. EndpointOdds Ratio*Confidence Intervals Combined Events3.42.8—4.2 (Cardiac arrest, Cardiac Perforation, Pneumothorax, Cardiac Tamponade, Infection) In hospital Death2.11.5—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

15. Conclusions Acute lead dislodgements—most common adverse events (1.1%) Individuals with greater comorbidities at greater risk Formalized EP training associated with fewer events

16. Conclusions (cont’d) Downstream adverse events occur 10.9% Lead dislodgments increase risk for major complications and in hospital death after adjustment for confounders