Impact of Impact of Anticoagulant and Anti- Anticoagulant and Anti-platelet Therapy on platelet Therapy on

ICD Implant-Related Bleeding and ICD Implant-Related Bleeding and Thromboembolic Events in Thromboembolic Events in

Patients Patients Enrolled in the NCDREnrolled in the NCDR®® ICD ICD

RegistryRegistryTMTMAlena Goldman, MD*, Jeptha P. Curtis, Alena Goldman, MD*, Jeptha P. Curtis, MD MD †, Yongfei Wang, MS, Yongfei Wang, MS†, William H. , William H.

Maisel, MD, MPH*.Maisel, MD, MPH*.* Beth Israel Deaconess Medical Center, Boston, MA* Beth Israel Deaconess Medical Center, Boston, MA

† Yale-New Haven Hospital, New Haven, CTYale-New Haven Hospital, New Haven, CT

Disclosures Alena Goldman, Jeptha P. Curtis, Alena Goldman, Jeptha P. Curtis,

Yongfei Wang, William H. Yongfei Wang, William H. Maisel:Maisel:

No Industry Relationships to Disclose

BackgroundBackground >400K pacemaker and ICD implants a >400K pacemaker and ICD implants a

year in North Americayear in North America11.. Perioperative management of Perioperative management of

anticoagulation in patients undergoing anticoagulation in patients undergoing device implant is not firmly device implant is not firmly established.established.

Uninterrupted DAP mandated for Uninterrupted DAP mandated for millions of stent patientsmillions of stent patients22..

Impact on ICD implant complications Impact on ICD implant complications has not been evaluated.has not been evaluated.

1 AHA Heart Disease and Stroke Statistics 20012 Maisel WH. N Engl J Med. 2007; 356(10):981-4

Clinical Implications of Pocket Clinical Implications of Pocket HematomaHematoma

Interruption of anticoagulationInterruption of anticoagulation Blood product transfusionBlood product transfusion Longer hospital stayLonger hospital stay Hematoma evacuationHematoma evacuation Increased risk of infectionIncreased risk of infection Risk of thromboembolism if Risk of thromboembolism if

anticoagulation is interruptedanticoagulation is interrupted

BackgroundBackground

NCDR ICD Registry DatabaseNCDR ICD Registry Database Developed by ACC/HRS in October of 2005 Developed by ACC/HRS in October of 2005 Collects information from 1,500 hospitals in USCollects information from 1,500 hospitals in US Required for all Medicare primary prevention Required for all Medicare primary prevention

ICD implantsICD implants 76% of hospitals submit all implants76% of hospitals submit all implants 88% of all ICD implants in US included88% of all ICD implants in US included Good representation of “real-world” performanceGood representation of “real-world” performance

Goals:Goals: Track outcomes Track outcomes Determine if findings from major RCTs apply to general Determine if findings from major RCTs apply to general

population population 11 1. S. Hammill, et. al. Heart Rhythm 2008;6:1359-1363

Methods

> 130 data elements collected at the time > 130 data elements collected at the time of the initial ICD implant, device upgrade, of the initial ICD implant, device upgrade, and device replacementand device replacement

Discharge medications recorded – No Discharge medications recorded – No record of medications at time of implantrecord of medications at time of implant

Complications at the time of device Complications at the time of device implantation and prior to hospital implantation and prior to hospital discharge are collected discharge are collected

Used data from 4/06-12/08Used data from 4/06-12/08

MethodsNCDR ICD Registry DatabaseNCDR ICD Registry Database

HEMATOMAHEMATOMA Resulting in re-Resulting in re-

operation or operation or transfusiontransfusion

NON-HEMATOMA NON-HEMATOMA BLEEDINGBLEEDING

Cardiac Perforation Cardiac Perforation Cardiac TamponadeCardiac Tamponade Hemothorax Hemothorax

Study Endpoints(Based on NCDR Complication (Based on NCDR Complication

Definitions)Definitions)THROMBOEMBOLISTHROMBOEMBOLIS

MM MIMI TIA/CVATIA/CVA DVTDVT Peripheral embolusPeripheral embolus

Patient CharacteristicsPatient CharacteristicsCharacteristics 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

Characteristics Number Percent

1o Prevention 236342 89.1

2o Prevention 27070 10.3

Non-ischemicdilated CM

80590 30.6

Ischemic heartdisease

174314 66.2

Prior MI 143881 54.6

Prior CABG 94112 35.7

Prior PCI 84923 32.2

Patient CharacteristicsPatient Characteristics

13.7

35.5

3.1

1

2.4

11.6

15.8

16.8

0

5

10

15

20

25

30

35

40

Per

cen

t o

f P

atie

nts

Baseline Antiplatelet/Anticoagulation Treatment

None ASA T/C DAP Warfarin Warfarin Warfarin Warfarin + ASA + T/C + DAP

263,412 ICD Implants

0.740.59

0.93 0.91

1.65

1.32

1.44

1.221.04

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1.8

%

None ASA T/C DAP Warfarin Warfarin Warfarin Warfarin Overall + ASA + T/C + DAP

Effect of AC and AP Therapy on Effect of AC and AP Therapy on Hematoma RateHematoma Rate

P for trend for <0.001

263,412 ICD Implants – 2404 Hematomas

P for trend <0.0001

0.26

0.160.14

0.19 0.19 0.18

0.12

0.180.17

0

0.05

0.1

0.15

0.2

0.25

0.3

%

P for trend =0.004

Effect of AC and AP Therapy on Effect of AC and AP Therapy on Non-Hematoma Non-Hematoma

Bleeding RateBleeding Rate

263,412 ICD Implants – 483 events

None ASA T/C DAP Warfarin Warfarin Warfarin Warfarin Overall + ASA + T/C + DAP

0.09

0.28

0.12

0.05

0.410.42

0.17

0.10.12

0

0.05

0.1

0.15

0.2

0.25

0.3

0.35

0.4

0.45

P for trend for <0.001

Effect of AC and AP Therapy Effect of AC and AP Therapy on Clotting Rateon Clotting Rate

263,412 ICD Implants - 322 events

%

None ASA T/C DAP Warfarin Warfarin Warfarin Warfarin Overall + ASA + T/C + DAP

P for trend <0.0001

Impact of Heart Failure on Impact of Heart Failure on Complication RatesComplication Rates

Hematoma*

* P<0.02 compared

to NYHA

Class INon HematomaBleeding

NYHA ClassNYHA Class

II IIII IIIIII IVIV

ClottingClotting

*

NYHA

Class

%^

I 14II 35.8III 45.9IV 4.3

^ Percent of ^ Percent of total implantstotal implants

II IIII IIIIII IVIV

II IIII IIIIII IVIV

**

*

*

% 0 0.5 1.0 % 0 0.5 1.0 1.5 1.5

% 0 0.1 0.2 % 0 0.1 0.2 0.3 0.3

% 0 0.1 0.2 % 0 0.1 0.2 0.3 0.3

Impact of Device Type on Impact of Device Type on Complication RatesComplication Rates

Hematoma

Non HematomaBleeding

Device TypeDevice Type

SS

DD

BB

ClottingClotting

^ Percent of ^ Percent of total implantstotal implants

*

*

*

% 0 0.5 1.0 % 0 0.5 1.0 1.5 1.5

% 0 0.06 % 0 0.06 0.12 0.180.12 0.18

SS

DD

BB

SS

DD

BB

% 0 0.5 1.0 % 0 0.5 1.0 1.5 1.5

* P<0.001Devic

e Type

%^

(S) Singl

e

22.6

(D) Dual

39.9

(B) Bi-V

37.7

Impact of Procedure Type on Impact of Procedure Type on Complication RatesComplication Rates

Hematoma

Non HematomaBleeding

Procedure Procedure TypeType

ClottingClotting

^ Percent of ^ Percent of total implantstotal implants

*

*

*

% 0 0.5 1.0 % 0 0.5 1.0 1.5 1.5

% 0 0.1 0.2 % 0 0.1 0.2 0.3 0.3

% 0 0.1 0.2 % 0 0.1 0.2 0.3 0.3

* P<0.01 compared to Gen ∆∆

Device Type

%^

Gen ∆∆ 16.2New

Implant

75.2

Device Upgra

de

5.6

Gen. ∆Gen. ∆

NewNew

UpgradeUpgrade

Gen. ∆Gen. ∆

NewNew

UpgradeUpgrade

Gen. ∆Gen. ∆

NewNew

UpgradeUpgrade

*

*

*

0 0.5 1 1.5

Hospital Volume(Implants/yr)

Low(<59/yr)

Middle(60-213/yr)

High (>214/yr)

P for trend <0.001

Impact of Hospital Implant Impact of Hospital Implant Volume on Hematoma RateVolume on Hematoma Rate

263,412 ICD Implants

Hematoma (%)

Hospital

Volume

%*

Low 3.8Middl

e20.7

High 75.5* Percent of * Percent of

total total implantsimplants

LimitationsLimitations

Discharge medications recorded – Discharge medications recorded – not necessarily medications at time not necessarily medications at time of procedureof procedure

Medication choices not randomizedMedication choices not randomized Potential underreporting of Potential underreporting of

complicationscomplications

ConclusionsConclusions

Although anticoagulation and Although anticoagulation and antiplatelet therapy are associated antiplatelet therapy are associated with increased ICD implant with increased ICD implant hematoma rates, overall rates are hematoma rates, overall rates are low.low.

DAP, warfarin, and triple therapy DAP, warfarin, and triple therapy are associated with progressively are associated with progressively higher bleeding rates.higher bleeding rates.

ConclusionsConclusions

Worsening NYHA class, increasing Worsening NYHA class, increasing ICD device complexity, procedure ICD device complexity, procedure type, and lower hospital implant type, and lower hospital implant volume are independently associated volume are independently associated with increased rates of hematoma, with increased rates of hematoma, non-hematoma bleeding, and non-hematoma bleeding, and thromboembolic events.thromboembolic events.

These data should be considered when These data should be considered when selecting patients for ICD implant.selecting patients for ICD implant.