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Alena Goldman, MD*, Jeptha P. Curtis, MD † , Yongfei Wang, MS † , William H. Maisel, MD, MPH*. * Beth Israel Deaconess

Impact of Anticoagulant and Anti-platelet Therapy on ICD Implant-Related Bleeding and Thromboembolic Events in Patients Enrolled in the NCDR ® ICD Registry TM.

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Alena Goldman, MD*, Jeptha P. Curtis, MD † , Yongfei Wang, MS † , William H. Maisel, MD, MPH*. * Beth Israel Deaconess

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  1. Impact of Anticoagulant and Anti-platelet Therapy on ICD Implant-Related Bleeding and Thromboembolic Events in Patients Enrolled in the NCDR® ICD RegistryTM Alena Goldman, MD*, Jeptha P. Curtis, MD †, Yongfei Wang, MS†, William H. Maisel, MD, MPH*. * Beth Israel Deaconess Medical Center, Boston, MA † Yale-New Haven Hospital, New Haven, CT

  2. Disclosures • Alena Goldman, Jeptha P. Curtis, Yongfei Wang, William H. Maisel: • No Industry Relationships to Disclose

  3. Background • >400K pacemaker and ICD implants a year in North America1. • Perioperative management of anticoagulation in patients undergoing device implant is not firmly established. • Uninterrupted DAP mandated for millions of stent patients2. • Impact on ICD implant complications has not been evaluated. 1 AHA Heart Disease and Stroke Statistics 2001 2 Maisel WH. N Engl J Med. 2007; 356(10):981-4

  4. Background Clinical Implications of Pocket Hematoma • Interruption of anticoagulation • Blood product transfusion • Longer hospital stay • Hematoma evacuation • Increased risk of infection • Risk of thromboembolism if anticoagulation is interrupted

  5. Methods NCDR ICD Registry Database • Developed by ACC/HRS in October of 2005 • Collects information from 1,500 hospitals in US • Required for all Medicare primary prevention ICD implants • 76% of hospitals submit all implants • 88% of all ICD implants in US included • Good representation of “real-world” performance • Goals: • Track outcomes • Determine if findings from major RCTs apply to general population 1 1. S. Hammill, et. al. Heart Rhythm 2008;6:1359-1363

  6. Methods NCDR ICD Registry Database • > 130 data elements collected at the time of the initial ICD implant, device upgrade, and device replacement • Discharge medications recorded – No record of medications at time of implant • Complications at the time of device implantation and prior to hospital discharge are collected • Used data from 4/06-12/08

  7. Study Endpoints (Based on NCDR Complication Definitions) HEMATOMA • Resulting in re-operation or transfusion NON-HEMATOMA BLEEDING • Cardiac Perforation • Cardiac Tamponade • Hemothorax THROMBOEMBOLISM • MI • TIA/CVA • DVT • Peripheral embolus

  8. Patient Characteristics

  9. Patient Characteristics

  10. Baseline Antiplatelet/Anticoagulation Treatment 263,412 ICD Implants Percent of Patients None ASA T/C DAP Warfarin Warfarin Warfarin Warfarin + ASA + T/C + DAP

  11. Effect of AC and AP Therapy on Hematoma Rate P for trend <0.0001 % None ASA T/C DAP Warfarin Warfarin Warfarin Warfarin Overall + ASA + T/C + DAP 263,412 ICD Implants – 2404 Hematomas P for trend for <0.001

  12. Effect of AC and AP Therapy on Non-Hematoma Bleeding Rate % None ASA T/C DAP Warfarin Warfarin Warfarin Warfarin Overall + ASA + T/C + DAP 263,412 ICD Implants – 483 events P for trend =0.004

  13. Effect of AC and AP Therapy on Clotting Rate P for trend <0.0001 % None ASA T/C DAP Warfarin Warfarin Warfarin Warfarin Overall + ASA + T/C + DAP 263,412 ICD Implants - 322 events P for trend for <0.001

  14. Impact of Heart Failure on Complication Rates NYHA Class *P<0.02 compared to NYHA Class I I II III IV Hematoma * * % 0 0.5 1.0 1.5 Non Hematoma Bleeding I II III IV * * % 0 0.1 0.2 0.3 I II III IV Clotting * ^ Percent of total implants * % 0 0.1 0.2 0.3

  15. Impact of Device Type on Complication Rates Device Type * P<0.001 S D B Hematoma * % 0 0.5 1.0 1.5 Non Hematoma Bleeding S D B * % 0 0.5 1.0 1.5 S D B Clotting ^ Percent of total implants * % 0 0.06 0.12 0.18

  16. Impact of Procedure Type on Complication Rates Procedure Type * P<0.01 compared to Gen ∆ Gen. ∆ New Upgrade Hematoma * * % 0 0.5 1.0 1.5 Non Hematoma Bleeding Gen. ∆ New Upgrade * * % 0 0.1 0.2 0.3 Gen. ∆ New Upgrade Clotting * ^ Percent of total implants * % 0 0.1 0.2 0.3

  17. Impact of Hospital Implant Volume on Hematoma Rate Hospital Volume (Implants/yr) 263,412 ICD Implants Low (<59/yr) Middle (60-213/yr) High (>214/yr) P for trend <0.001 * Percent of total implants Hematoma (%)

  18. Limitations • Discharge medications recorded – not necessarily medications at time of procedure • Medication choices not randomized • Potential underreporting of complications

  19. Conclusions • Although anticoagulation and antiplatelet therapy are associated with increased ICD implant hematoma rates, overall rates are low. • DAP, warfarin, and triple therapy are associated with progressively higher bleeding rates.

  20. Conclusions • Worsening NYHA class, increasing ICD device complexity, procedure type, and lower hospital implant volume are independently associated with increased rates of hematoma, non-hematoma bleeding, and thromboembolic events. • These data should be considered when selecting patients for ICD implant.

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