ICD Implant Related Bleeding in an Era of Dual Antiplatelet Therapy

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

• gt400K 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
Clinical Implications of Pocket Hematoma
Background

• Interruption of anticoagulation
• Blood product transfusion
• Longer hospital stay
• Hematoma evacuation
• Increased risk of infection
• Risk of thromboembolism if anticoagulation is
  interrupted

5
NCDR ICD Registry Database
Methods

• 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
200861359-1363
6
Methods
NCDR ICD Registry Database

• gt 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
Characteristics Number Percent
Patients 260,408 100
ICD Implants 263,412 100
Mean Age 68.0 -
Female 68276 25.9
AF 88273 33.5
HTN 194711 73.9
DM 95743 36.4
CHF 202583 76.9
Prior CVA 38662 14.7
9
Patient Characteristics
Characteristics Number Percent
1o Prevention 236342 89.1
2o Prevention 27070 10.3
Non-ischemic dilated CM 80590 30.6
Ischemic heart disease 174314 66.2
Prior MI 143881 54.6
Prior CABG 94112 35.7
Prior PCI 84923 32.2
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 lt0.0001

None ASA T/C DAP
Warfarin Warfarin Warfarin Warfarin
Overall ASA
T/C DAP
263,412 ICD Implants 2404 Hematomas
P for trend for lt0.001
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 lt0.0001

None ASA T/C DAP
Warfarin Warfarin Warfarin Warfarin Overall
ASA T/C
DAP
263,412 ICD Implants - 322 events
P for trend for lt0.001
14
Impact of Heart Failure on Complication Rates
NYHA Class
Plt0.02 compared to NYHA Class I
I II III IV
Hematoma


0 0.5
1.0 1.5
NYHA Class
I 14
II 35.8
III 45.9
IV 4.3
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
Plt0.001
S D B
Hematoma

Device Type
(S) Single 22.6
(D) Dual 39.9
(B) Bi-V 37.7
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
Plt0.01 compared to Gen ?
Gen. ? New Upgrade
Hematoma


0 0.5 1.0
1.5
Device Type
Gen ? 16.2
New Implant 75.2
Device Upgrade 5.6
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
• (lt59/yr)
• Middle
• (60-213/yr)
• High (gt214/yr)

Hospital Volume
Low 3.8
Middle 20.7
High 75.5
P for trend lt0.001
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.