Data Collection for Medicare Beneficiaries Receiving Implantable Cardioverter-defibrillators for Primary Prevention of Sudden Cardiac Death

Data Collection for Medicare Beneficiaries Receiving Implantable Cardioverter-defibrillators for Primary Prevention of Sudden Cardiac Death

ICDDataDictionaryv1 0

Data Collection for Medicare Beneficiaries Receiving Implantable Cardioverter-defibrillators for Primary Prevention of Sudden Cardiac Death

OMB: 0938-0967

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Implantable Cardioverter Defibrillators Registry v1.08

Data Dictionary - Full Specifications

A. Participant Administration

Field Name: Participant ID

Seq No: 1000

Short Name: PartId

Core: Yes

Status: New

Harvested: Yes

Format: Integer
Data Source: Automatic
Parent Element:
Parent Value:
Missing Data: Illegal
Valid Range: 1-999999
Usual Range:
Description: Participant ID
Definition: Participant ID is a unique number assigned to each Participant by the ACC-NCDR. An ACC
-NCDR Participant is defined as one entity that signs a Participation Agreement with the
ACC, submits one data submission file to the harvest, and gets back one Outcomes Report
on their data.��
��
Each Participant's data if submitted to harvest must be in one data submission file. If one
Participant keeps their data in more than one file (e.g. at two sites), then the data must be
combined into a single data submission file for the harvest.��
��
If two or more Participants share a single purchased software, and enter cases into one
database, then the data must be exported into different data submisison files, one for each
Participant ID.
Selections:
Field Name: Participant Name

Seq No: 1010

Short Name: PartName

Core: Yes

Status: New

Harvested: Yes

Format: Text (100)
Data Source: Automatic
Parent Element:
Parent Value:
Missing Data: Illegal
Valid Range:
Usual Range:
Description: Participant Name
Definition: The full official hospital name of the facility where the implant procedure was performed.
Values should be full, official hospital names with no abbreviations or variations in spelling
for a single hospital.
Selections:
Seq No: 1015

Field Name: Medicare Provider Number
Short Name: MPN

Core: Yes

Status: New

Harvested: Yes

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Format: Text (6)

Data Source: Client

Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Medicare Provider Number
Definition: Indicate the medicare provider number of the facility at which the patient received the
implant.
Selections:
Field Name: Participant NPI

Seq No: 1016

Short Name: PartNPI

Core: Yes

Status: New

Harvested: Yes

Format: Text (10)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Participant National Provider Identifier
Definition: Indicate the hospital's (N)ational (P)rovider (I)dentifier. NPIs, assigned by CMS, are used to
uniquely identify hospitals for Medicare billing purposes.
Selections:
Field Name: Timeframe of Data Submission

Seq No: 1020

Short Name: Timeframe

Core: Yes

Status: New

Harvested: Yes

Format: Text (6)
Data Source: Automatic
Parent Element:
Parent Value:
Missing Data: Illegal
Valid Range:
Usual Range:
Description: Timeframe of Data Submission
Definition: Indicate the timeframe of data included in the data submission. Format: YYYYQQ. e.g.
2005Q4
Selections:
Field Name: Transmission Number

Seq No: 1040
Core: Yes

Short Name: XmsnId

Harvested: Yes

Status: New
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Format: Integer

Data Source: Automatic

Parent Element:
Parent Value:
Missing Data: Illegal
Valid Range: 1-999999999
Usual Range:
Description: Transmission Number
Definition: A unique number created and automatically inserted by the software. It identifies the
number of times the software has created data submission files. The transmission number
should be incremented by one every time the data submission files are exported. The
transmission number should never be repeated.
Selections:
Field Name: Software Vendor Identifier

Seq No: 1050

Short Name: VendorId

Core: Yes

Status: New

Harvested: Yes

Format: Text (15)
Data Source: Automatic
Parent Element:
Parent Value:
Missing Data: Illegal
Valid Range:
Usual Range:
Description: Software Vendor Identifier
Definition: Software Vendor Identification (agreed upon by mutual selection between the vendor and
the ACC) to identify software vendor. Vendors must use consistent name identification
across sites. Changes to Vendor Name Identification must be approved by the ACC.
Selections:
Field Name: Vendor software version

Seq No: 1060

Short Name: VendorVer

Core: Yes

Status: New

Harvested: Yes

Format: Text (20)
Data Source: Automatic
Parent Element:
Parent Value:
Missing Data: Illegal
Valid Range:
Usual Range:
Description: Vendor software version
Definition: Vendor's software product name and version number identifying the software which created
this record (assigned by vendor). Vendor controls the value in this field. Version passing
certification/harvest testing will be noted at the ACC.
Selections:
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Data Dictionary - Full Specifications

Field Name: Registry Identifier

Seq No: 1070

Short Name: RegistryId

Core: Yes

Status: New

Harvested: Yes

Format: Text (20)
Data Source: Automatic
Parent Element:
Parent Value:
Missing Data: Illegal
Valid Range:
Usual Range:
Description: Registry Identifier
Definition: The ACC-NCDR Registry Identifier describes which ACC data registry these records apply.
It is implemented in the software at the time the data is collected and the records are
created. This is entered into the schema automatically by software.
Selections:
Field Name: Registry Version

Seq No: 1080

Short Name: RegistryVer

Core: Yes

Status: New

Harvested: Yes

Format: Text (10)
Data Source: Automatic
Parent Element:
Parent Value:
Missing Data: Illegal
Valid Range:
Usual Range:
Description: Registry Version
Definition: Registry Version describes the version number of the Data Specifications/Dictionary, to
which each record conforms. It identifies which fields should have data, and what are the
valid data for each field. It is the version implemented in the software at the time the data is
collected and the records are created. This is entered into the schema automatically by
software.
Selections:
Field Name: Patient Population

Seq No: 1090

Short Name: PatientPop

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Illegal
Valid Range:
Usual Range:
Description: Patient Population
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Definition: Indicate the population of patients that should be included in the data export and submitted to the
registry.
Selections: Coding/Sort

Selection(Choose one)

Explanation

1

All Patients

All patients regardless of insurance payor
and ICD Indication.

2

CMS Primary Prevention Patients

Patients with a Primary or
Secondary insurance payor
of "Medicare" and an ICD
Indication of "Primary Prevention".

Field Name: Data Submission File Password

Seq No: 1100

Short Name: Password

Core: Yes

Status: New

Harvested: No

Format: Text (20)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: No action
Valid Range:
Usual Range:
Description: Data Submission File Password
Definition: Indicates the ACC assigned password that should be applied to the data submission zip file.
Selections:
Field Name: Auxiliary 0

Seq No: 1110

Short Name: Aux0

Core: Yes

Status: New

Harvested: Yes

Format: Text (50)
Data Source: Automatic
Parent Element:
Parent Value:
Missing Data: No action
Valid Range:
Usual Range:
Description: Auxiliary 0
Definition: Not for participant use. A 50 character text field that may be used to collect additional administrative
information about the data submission.
Selections:

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Data Dictionary - Full Specifications

B. Demographics

Field Name: Patient Last Name

Seq No: 2000

Short Name: Surname

Core: Yes

Status: New

Harvested: Yes

Format: Text (25)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Patient Last Name
Definition: Indicate the patient's last name.
Selections:
Field Name: Patient First Name

Seq No: 2010

Short Name: GivenName

Core: Yes

Status: New

Harvested: Yes

Format: Text (25)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Patient First Name
Definition: Indicate the patient's first name.
Selections:
Field Name: Patient Middle Name

Seq No: 2020

Short Name: MiddleName

Core: Yes

Status: New

Harvested: Yes

Format: Text (25)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Patient Middle Name
Definition: Indicate the patient's middle name or middle initial.
Selections:
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Data Dictionary - Full Specifications

Field Name: Patient SSN

Seq No: 2030

Short Name: SSN

Core: Yes

Status: New

Harvested: Yes

Format: Text (9)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Patient SSN
Definition: Indicate the nine digit patient's United States Social Security Number (SSN). If the patient
does not have a US assigned SSN, then leave the SSN blank.
Selections:
Field Name: Unique Patient ID

Seq No: 2040

Short Name: PatientId

Core: Yes

Status: New

Harvested: Yes

Format: Integer
Data Source: Automatic
Parent Element:
Parent Value:
Missing Data: Illegal
Valid Range: 1-999999999
Usual Range:
Description: Unique Patient ID
Definition: This is an arbitrary number (not a recognizable ID like SSN or Medical Record Number) that
uniquely identifies each patient. Once assigned to a patient at a health care facility, this will
never be changed or reassigned to a different patient. If a patient returns to the same
hospital, or for follow-up, they will receive this same unique patient identifier.
Selections:
Field Name: Other ID

Seq No: 2045

Short Name: OtherId

Core: Yes

Status: New

Harvested: Yes

Format: Text (50)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: No action
Valid Range:
Usual Range:
Description: Other ID
Definition: An additional 'optional' patient identifier, such as medical record number, that can be
associated with the patient.
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Data Dictionary - Full Specifications

Selections:
Field Name: Patient DOB

Seq No: 2050

Short Name: DOB

Core: Yes

Status: New

Harvested: Yes

Format: Date (mm/dd/yyyy)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range: Patient DOB > 01/01/1850 and Patient DOB < Previous ICD Date and Patient DOB < Previous
CABG Date and Patient DOB < Admission Date
Usual Range:
Description: Patient date of birth
Definition: Indicate the patient's date of birth.
Selections:
Field Name: Gender

Seq No: 2060

Short Name: Gender

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Gender
Definition: Indicate the patient's gender at birth.
Selections: Coding/Sort

Selection(Choose one)

1

Male

2

Female

Explanation

Seq No: 2070

Field Name: Race

Core: Yes

Short Name: Race

Harvested: Yes

Status: New
Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Race
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Data Dictionary - Full Specifications

Definition: Indicate the patient's race as determined by the patient/family.
Selections: Coding/Sort

Selection(Choose one)

1

White

2

Black/African American

4

Asian

5

American Indian/Alaska Native

6

Native Hawaiian

7

Other

Field Name: Hispanic Ethnicity

Explanation

Seq No: 2075

Short Name: HispEthnicity

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Hispanic Ethnicity
Definition: Indicate if the patient is of hispanic ethnicity.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: Auxiliary 1

Explanation

Seq No: 2080

Short Name: Aux1

Core: Yes

Status: New

Harvested: Yes

Format: Text (50)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: No action
Valid Range:
Usual Range:
Description: Auxiliary 2
Definition: For participant use only. A 50 character text field that may be used to collect additional information
about the patient or admission.
Selections:
Field Name: Auxiliary 2

Seq No: 2090

Short Name: Aux2

Core: Yes

Status: New

Harvested: Yes

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Format: Text (50)

Data Source: Client

Parent Element:
Parent Value:
Missing Data: No action
Valid Range:
Usual Range:
Description: Auxiliary 2
Definition: For participant use only. A 50 character text field that may be used to collect additional
information about the patient or admission.
Selections:

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Data Dictionary - Full Specifications

C. Admission

Field Name: Admission Date

Seq No: 3000

Short Name: AdmitDate

Core: Yes

Status: New

Harvested: Yes

Format: Date (mm/dd/yyyy)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Illegal
Valid Range: Admission Date > Previous ICD Date and Admission Date > PrevCABGDate and Admission
Date <= Date of Implant
Usual Range:
Description: Admission Date
Definition: Indicate the date on which the patient was admitted to the hospital for the current stay.
Selections:
Field Name: Date of Implant

Seq No: 3010

Short Name: ImplantDate

Core: Yes

Status: New

Harvested: Yes

Format: Date (mm/dd/yyyy)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Illegal
Valid Range: Date of Implant >= Admission Date and Date of Implant <= Date of Discharge
Usual Range:
Description: ICD Implant Date
Definition: Indicate the date of the ICD implant.��
��
Note: In the event that multiple ICDs were implanted/explanted during a single admission,
this is the date of the first/initial ICD implant. For clarification, see Sequence Numbers 3507,
3508.
Selections:
Field Name: Insurance Payor-Primary

Seq No: 3020

Short Name: PayorPrim

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Illegal
Valid Range:

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Data Dictionary - Full Specifications

Usual Range:

Description: Insurance Payor-Primary

Definition: Indicate the patient's primary insurance payor.
Selections: Coding/Sort

Selection(Choose one)

Explanation

1

Government

*RYHUQPHQWUHIHUVWRSDWLHQWVZKRDUH
FRYHUHGE\JRYHUQPHQWUHLPEXUVHGFDUH
,QWKH86WKLVLQFOXGHV0HGLFDUH
0HGLFDLGLQFOXGLQJDOOVWDWHIHGHUDO
0HGLFDLGW\SHSURJUDPV7UL&DUHWKH
9HWHUDQ
V$GPLQLVWUDWLRQ+HDOWK3ODQDQG
)HGHUDO(PSOR\HH¶V,QVXUDQFH

2

Commercial

Commercial refers to all indemnity (fee­
for-service) carriers and Preferred
Provider Organizations (PPOs) (e.g. Blue
Cross/Blue Shield).

3

HMO

HMO refers to a Health Maintenance
Organization (HMO) characterized by
coverage that provides health services
for members on a pre-paid basis.

4

Non-U.S. Insurance

Non-US Insurance refers to individuals
who reside in and have health insurance
in another country.

5

None/Self Pay

None/Self Pay refers to individuals with
no or limited health insurance; thus, the
individual is the payor regardless of
ability to pay.

Field Name: Government Type-Primary

Seq No: 3025

Short Name: GovTypePrim

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element: Insurance Payor-Primary(3020)
Parent Value: Government
Missing Data: Illegal
Valid Range:
Usual Range:
Description: Government Insurance Type-Primary
Definition: Indicate the type of insurance if the patient's primary insurance payor is Government.
Selections: Coding/Sort

Selection(Choose one)

1

Medicare

2

Medicaid

3

TriCare

4

Veteran's Administration Health Plan

5

Federal Employee Insurance

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23-May-06

Explanation

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Data Dictionary - Full Specifications

Field Name: Insurance Payor-Secondary

Seq No: 3027

Short Name: PayorSecond

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Illegal
Valid Range:
Usual Range:
Description: Insurance Payor-Secondary
Definition: Indicate the patient's secondary insurance payor.
Selections: Coding/Sort

Selection(Choose one)

Explanation

1

Government

*RYHUQPHQWUHIHUVWRSDWLHQWVZKRDUH
FRYHUHGE\JRYHUQPHQWUHLPEXUVHGFDUH
,QWKH86WKLVLQFOXGHV0HGLFDUH
0HGLFDLGLQFOXGLQJDOOVWDWHIHGHUDO
0HGLFDLGW\SHSURJUDPV7UL&DUHWKH
9HWHUDQ
V$GPLQLVWUDWLRQ+HDOWK3ODQDQG
)HGHUDO(PSOR\HH¶V,QVXUDQFH

2

Commercial

Commercial refers to all indemnity (fee­
for-service) carriers and Preferred
Provider Organizations (PPOs) (e.g. Blue
Cross/Blue Shield).

3

HMO

HMO refers to a Health Maintenance
Organization (HMO) characterized by
coverage that provides health services
for members on a pre-paid basis.

4

Non-U.S. Insurance

Non-US Insurance refers to individuals
who reside in and have health insurance
in another country.

5

None/Self Pay

None/Self Pay refers to individuals with
no or limited health insurance; thus, the
individual is the payor regardless of
ability to pay.

Field Name: Government Type-Secondary

Seq No: 3029

Short Name: GovTypeSecond

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element: Insurance Payor-Secondary(3027)
Parent Value: Government
Missing Data: Illegal
Valid Range:
Usual Range:
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Data Dictionary - Full Specifications

Description: Government Insurance Type-Secondary
Definition: Indicate the type of insurance if the patient's secondary insurance payor is Government.
Selections: Coding/Sort

Selection(Choose one)

1

Medicare

2

Medicaid

3

TriCare

4

Veteran's Administration Health Plan

5

Federal Employee Insurance

Field Name: Reason for Admission

Explanation

Seq No: 3030

Short Name: AdmissionReason

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Reason for Admission
Definition: Indicate the primary reason the patient was hospitalized for this admission.
Selections: Coding/Sort

Selection(Choose one)

Explanation

1

Admitted for this Procedure

Admitted for ICD implantation.

2

Cardiac-CHF

Admitted for management of heart failure
other than implantation of an ICD.

3

Cardiac-Other

Admitted for a cardiac reason other than
heart failure or implantation of an ICD.

4

Non-Cardiac

Admitted for a non-cardiac reason other
than implantation of an ICD.

Field Name: Auxiliary 3

Seq No: 3040

Short Name: Aux3

Core: Yes

Status: New

Harvested: Yes

Format: Text (50)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: No action
Valid Range:
Usual Range:
Description: Auxiliary 3
Definition: For participant use only. A 50 character text field that may be used to collect additional information
about the patient or admission.
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Selections:
Field Name: Auxiliary 4

Seq No: 3050

Short Name: Aux4

Core: Yes

Status: New

Harvested: Yes

Format: Text (50)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: No action
Valid Range:
Usual Range:
Description: Auxiliary 4
Definition: For participant use only. A 50 character text field that may be used to collect additional
information about the patient or admission.
Selections:

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D. History and Risk Factors

Field Name: Syncope

Seq No: 3060

Short Name: Syncope

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Syncope
Definition: Indicate if the patient had a sudden loss of consciousness, including loss of postural tone (not
related to anesthesia) with spontaneous recovery as reported by the patient or an observer. Patient
may experience syncope when supine.��
��
Note: Patient history is defined as any time prior to the date of implant.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: Family Hx Sudden Death

Explanation

Seq No: 3070

Short Name: FHSudDeath

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Family History of Sudden Cardiac Death
Definition: Indicate if the patient has a known family history (parent or sibling) of sudden cardiac death.��
��
Sudden cardiac death is defined as a natural death due to cardiac causes heralded by abrupt loss of
consciousness, occurring before 75 years of age. The time and mode of death are unexpected even
though preexisting heart disease may have been known to be present. Traumatic death
subsequently proven to be due to sudden loss of control due to a cardiac problem is included. �
Coding Exception: If the patient is adopted, or the family history is unavailable, code "No".��
��
Note: Patient history is defined as prior to the current admission.��

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Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: CHF

Explanation

Seq No: 3080

Short Name: CHF

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Congestive Heart Failure
Definition: Indicate if the patient has a history of congestive heart failure (CHF), as documented in the medical
record. Besides physician documentation of the CHF history, CHF can also be defined by one of the
following:��
1. Paroxysmal nocturnal dyspnea (PND); ��
2. Dyspnea on exertion (DOE) due to heart failure; or ��
3. Chest X-Ray (CXR) showing pulmonary congestion; ��
4. Pedal edema or dyspnea treated with medical therapy for heart failure.��
��
Note: Patient history is defined as any time prior to the date of implant.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: CHF Duration

Explanation

Seq No: 3090

Short Name: CHFDuration

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element: CHF(3080)
Parent Value: Yes
Missing Data: Report
Valid Range:
Usual Range:
Description: Congestive Heart Failure Duration
Definition: Indicate the time since the initial CHF diagnosis.��
��
Note: This includes any time prior to date of implant.

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Selections: Coding/Sort

Selection(Choose one)

1

Within the past 3 months

2

3 to 9 months

3

Greater than 9 months

Field Name: Prior CHF Hospitalization

Explanation

Seq No: 3095

Short Name: PriorCHFHosp

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element: CHF(3080)
Parent Value: Yes
Missing Data: Report
Valid Range:
Usual Range:
Description: Prior Congestive Heart Failure Hospitalization
Definition: Indicate if the patient has ever been hospitalized for CHF prior to this admission. Indicate the
timeframe associated with that hospitalization.��
��
Note: This timeframe does NOT include this admission. The intent of this field is to capture
hospitalizations for CHF excluding the current admission.
Selections: Coding/Sort

Selection(Choose one)

0

Not Hospitalized

1

Yes-Within 6 months

2

Yes-Greater than 6 months

Field Name: NYHA Class - Current Status

Explanation

Seq No: 3100

Short Name: NYHAclass

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: NYHA Class - Current Status (at time of implant)
Definition: Indicate the patient's New York Heart Association (NYHA) classification.��
��
NOTE: For patients with no symptoms, code "Class 1".

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Selections: Coding/Sort

Selection(Choose one)

Explanation

1

Class I

Patient has cardiac disease but without
resulting limitations of ordinary physical
activity. Ordinary physical activity (e.g.,
walking several blocks or climbing stairs)
does not cause undue fatigue,
palpitation, dyspnea, or anginal pain.
Limiting symptoms may occur with
marked exertion.

2

Class II

Patient has cardiac disease resulting in
slight limitation of ordinary physical
activity. Patient is comfortable at rest.
Ordinary physical activity such as walking
more than two blocks or climbing more
than one flight of stairs results in limiting
symptoms (e.g., fatigue, palpitation,
dyspnea, or anginal pain).

3

Class III

Patient has cardiac disease resulting in
marked limitation of physical activity.
Patient is comfortable at rest. Less than
ordinary physical activity (e.g., walking
one to two level blocks or climbing one
flight of stairs) causes fatigue, palpitation,
dyspnea, or anginal pain.

4

Class IV

Patient has dyspnea at rest that
increases with any physical activity.
Patient has cardiac disease resulting in
inability to perform any physical activity
without discomfort. Symptoms may be
present even at rest. If any physical
activity is undertaken, discomfort is
increased.

Field Name: Cardiac Arrest

Seq No: 3110

Short Name: Arrest

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Cardiac Arrest
Definition: Indicate if the patient experienced cardiac arrest due to arrhythmia.��
��
Note: Patient history is defined as any time prior to the date of implant.��

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Selections: Coding/Sort

Selection(Choose one)

0

No Arrest

1

Brady Arrest

2

Tachy Arrest

Field Name: Brady Arrest Reason

Explanation

Seq No: 3111

Short Name: BradyArrest

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element: Cardiac Arrest(3110)
Parent Value: Brady Arrest
Missing Data: Report
Valid Range:
Usual Range:
Description: Brady Arrest Reason
Definition: Indicate the reason(s) for the Brady Arrest.
Selections: Coding/Sort

Selection(Choose multiple)

1

Acute MI

2

Severe Electrolyte Disturbance

3

Drug Induced Arrhythmia

4

Sinus Node Dysfunction/AV Block

5

Unknown Etiology

Field Name: Tachy Arrest Reason

Explanation

Seq No: 3112

Short Name: TachyArrest

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element: Cardiac Arrest(3110)
Parent Value: Tachy Arrest
Missing Data: Report
Valid Range:
Usual Range:
Description: Tachy Arrest Reason
Definition: Indicate the reason(s) for the Tachy Arrest.

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Selections: Coding/Sort

Selection(Choose multiple)

1

Acute MI

2

Severe Electrolyte Disturbance

3

Drug Induced Arrhythmia

4

Primary VT/VF

5

Unknown Etiology

Field Name: Atrial Fibrillation/Atrial Flu

Explanation

Seq No: 3120

Short Name: Flutter

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Atrial Fibrillation/Atrial Flutter
Definition: Indicate if the patient has a documented history of atrial fibrillation or flutter.��
��
Note: Patient history is defined as any time prior to the date of implant.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: Ventricular Tachycardia

Explanation

Seq No: 3130

Short Name: VT

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Ventricular Tachycardia
Definition: Indicate if the patient has a history of ventricular tachycardia (either spontaneous or induced) that led
to the placement of the ICD. Ventricular tachycardia is defined as a cardiac arrhythmia of 3 or more
consecutive complexes in duration emanating from the ventricles at a rate greater than 100 bpm
(cycle length less than 600 msec).��
��
Note: Patient history is defined as any time prior to the date of implant.

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Selections: Coding/Sort

Selection(Choose one)

Explanation

0

No

No history of spontaneous ventricular
tachycardia.

1

Yes-VT, Non-Sustained

Three or more consecutive beats of
ventricular origin, terminating
spontaneously in less than 30 seconds.

2

Yes-Monomorphic Sustained VT

VT greater than 30 seconds in duration
and/or requiring termination due to
hemodynamic compromise in less than
30 seconds.

3

Yes-Polymorphic Sustained VT

VT with a constantly changing
morphology lasting greater than 30
seconds in duration and/or requiring
termination due to hemodynamic
compromise in less than 30 seconds.

Field Name: Sinus Node Function

Seq No: 3140

Short Name: SinusNodeFn

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Sinus Node Function
Definition: Indicate if the patient's sinus node function was normal or abnormal.��
��
Note: Timeframe includes any time prior to the date of implant.
Selections: Coding/Sort

Selection(Choose one)

1

Normal

2

Abnormal

Explanation

Abnormal - History of any pause longer
than 3 seconds OR Tachy/Brady
Syndrome.

Field Name: Cardiac Transplant

Seq No: 3150

Short Name: XplantPrev

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
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Usual Range:
Description: Cardiac Transplant
Definition: Indicate if the patient had a history of cardiac transplant surgery. ��
��
Note: Patient history is defined as any time prior to the date of implant.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: Non-Ischemic Dilated Cardiomyopathy
Short Name: NIDilatedCardMyo

Explanation

Seq No: 3160
Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Non-Ischemic Dilated Cardiomyopathy
Definition: Indicate if the patient has a history of non-ischemic dilated cardiomyopathy documented by heart
failure and reduced systolic function.��
��
Note: Patient history is defined as any time prior to the date of implant.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes-Within the past 3 months

2

Yes-3 to 9 months

3

Yes-Greater than 9 months

Field Name: Ischemic Heart Disease

Explanation

Seq No: 3180

Short Name: IschemicHD

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Ischemic Heart Disease

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Definition: Indicate if the patient shows evidence of ischemic heart disease as documented by any of the
following conditions: ��
-At least one major epicardial artery with more than 70% obstruction by coronary angiography. ��
-Other Diagnostic Tests: History of myocardial infarction associated with wall motion abnormality as
shown by echocardiography or other cardiac imaging. Stress testing diagnostic of coronary artery
disease with or without imaging; ECG with evidence of MI; history of chest pain associated with
cardiac enzyme abnormality.��
��
Note: ��
1. Patient history is defined as any time prior to the date of implant.��
2. At least one major epicardial artery with more than 70% obstruction by coronary angiography
takes precedence over other diagnostic tests if ischemic heart disease has been documented.

Selections: Coding/Sort

Selection(Choose one)

Explanation

0

No

1

Yes-At Least 1 Epicardial artery greater
than 70% Obstruction

At least one epicardial artery greater than
70% obstruction (Angiography).

2

Yes-Other Diagnostic Tests

History of myocardial infarction
associated with wall motion abnormality
as shown by echocardiography or other
cardiac imaging. Stress testing
diagnostic of coronary artery disease with
or without imaging; ECG with evidence of
MI; history of chest pain associated with
cardiac enzyme abnormality.��

Field Name: Previous MI

Seq No: 3190

Short Name: PrevMITime

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Previous Myocardial Infarction and timeframe

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Definition: Indicate if the patient had a MI prior to the device implant.�
�
The patient had at least one documented STEMI or NSTEMI. This can be coded based on
physician documentation or history noted in the medical record.�
�
Definitions: NON ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI)�
�
The patient was hospitalized for a myocardial infarction documented in the medical record.�
�
AT LEAST ONE OF THE FOLLOWING BIOCHEMICAL INDICATORS for detecting
myocardial necrosis must be present (see below for a definition of Reference Control Limits):�
�
1) Troponin T or I:�
a) Maximal concentration of troponin T or I > the MI decision limit on at least one occasion
during the first 24 hours after the index clinical event.�
2) CK-MB:�
a) Maximal value of CK-MB > 2 x the upper limit of normal on one occasion during the first
hours after the index clinical event. OR�
b) Maximal value of CK-MB, preferable CK-MB mass, > upper limit of normal on two
successive samples.�
3) Total CK:�
a) In the absence of availability of a troponin or CK-MB assay, total CK > 2 x the upper
limit of normal, or the B fraction of CK may be employed, but these last two biomarkers are
considerably less satisfactory than CK-MB.�
�
AND ONE OF THE FOLLOWING:�
�
1) Either ST segment depression or T wave abnormalities; or�
2) Ischemic symptoms in the presence or absence of chest discomfort. Ischemic symptoms
may include:�
a) unexplained nausea and vomiting; or�
b) persistent shortness of breath secondary to left ventricular failure; or�
c) unexplained weakness, dizziness, lightheadedness, or syncope.�
�
ST ELEVATION MYOCARDIAL INFARCTION (STEMI)�
�
Indicate whether the patient was hospitalized for an ST Elevation Myocardial Infarction
(STEMI) documented in the medical record.�
�
AT LEAST ONE OF THE FOLLOWING BIOCHEMICAL INDICATORS for detecting
myocardial necrosis must be present (see below for a definition of Reference Control Limits):�
�
1) Troponin T or I:�
a) Maximal concentration of troponin T or I > the MI decision limit on at least one occasion
during the first 24 hours after the index clinical event.�
2) CK-MB:�
a) Maximal value of CK-MB > 2 x the upper limit of normal on one occasion during the first
hours after the index clinical event; OR�
b) Maximal value of CK-MB, preferable CK-MB mass, > upper limit of normal on two
successive samples.�
3) Total CK�
a) In the absence of availability of a troponin or CK-MB assay, total CK > 2 x the upper
limit of normal, or the B fraction of CK may be employed, but these last two biomarkers are
considerably less satisfactory than CK-MB.�
�
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Definition: AND ONE OF THE FOLLOWING ECG CHANGES:�
�
1) ST-segment elevation: New or presumed new ST segment elevation at the J point in two or more
continguous leads with the cut-off points >=0.2 mV in leads V1, V2, or V3, or >=0.1 mV in other
leads; OR�
2) Development of any Q wave in leads V1 through V3, or the development of a Q-wave > or = to 30
ms (0.03s) in leads I, II, aVL, aVF, V4, V5, or V6. (Q wave changes must be present in any two
continguous leads, and be > or = to 1mm in depth.)�
�
Defining Reference Control Values (MI Diagnostic Limit and Upper Limit of Normal):�
�
Reference values must be determined in each laboratory by studies using specific assays with
appropriate quality control, as reported in peer-reviewed journals. Acceptable imprecision
(coefficient of variation) at the 99th percentile for each assay should be defined as < or = to 10%.
Each individual laboratory should confirm the range of reference values in their specific setting.�
�
Note: If more than one MI occurred, code the most recent event.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes-Within 40 Days of ICD Implant

2

Yes-Greater than 40 Days prior to ICD
Implant

3

Yes-Both Within 40 days/Greater than 40
days

Field Name: Previous CABG

Explanation

Seq No: 3200

Short Name: PrevCABG

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Previous Coronary Artery Bypass Graft
Definition: Indicate if the patient had Coronary Bypass Graft Surgery by any approach.��
��
Note: Patient history is defined as any time prior to the current admission. Timeframe does NOT
include the current admission. CABGs performed during this admission should be coded within
Sequence Number 3590: CABG During this Admission.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: Previous CABG Date

Seq No: 3210

Short Name: PrevCABGDate
© 2005, American College of Cardiology Foundation

Explanation

Core: Yes
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Status: New

Harvested: Yes


Format: Date (mm/dd/yyyy)

Data Source: Client

Parent Element: Previous CABG(3200)
Parent Value: Yes
Missing Data: Report
Valid Range: Previous CABG Date > Patient DOB and Previous CABG Date < Admission Date
Usual Range:
Description: Previous Coronary Artery Bypass Graft Date
Definition: Indicate the date of the most recent CABG. If month and/or day are not known enter 01.��
��
Note: In the case of multiple CABGs prior to this admission, indicate the most recent.
Selections:
Field Name: Previous PCI

Seq No: 3220

Short Name: PrevPCI

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Previous Percutaneous Coronary Intervention
Definition: Indicate if the patient had a previous percutaneous coronary intervention (PCI) (even if unsuccessful)
of any type (balloon angioplasty, stent or other), performed prior to the current admission. ��
��
Note: Timeframe does NOT include the current admission. PCIs performed during this admission
should be coded within Sequence Number 3610: PCI During this Admission.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes-Within the past 3 months

2

Yes-Greater than 3 months

Field Name: Previous Valvular Surgery

Explanation

Seq No: 3230

Short Name: PrevValveSurg

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report

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Valid Range:
Usual Range:
Description: Previous Valve Surgery
Definition: Indicate if the patient had a previous surgical replacement and/or repair of a cardiac valve, by any
approach.��
��
Note: Patient history is defined as any time prior to the date of implant.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: Permanent Pacemaker

Explanation

Seq No: 3240

Short Name: PermPacemaker

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Permanent Pacemaker
Definition: Indicate if the patient had a Pacemaker inserted prior to current ICD implant. If yes, indicate the type
of pacemaker.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes-Atrial Chamber

2

Yes-Ventricular Chamber

3

Yes-Dual Chamber

4

Yes-Biventricular

Field Name: Previous ICD

Explanation

Both atrial and ventricular chambers.

Seq No: 3250

Short Name: PrevICD

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Previous ICD

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Definition: Indicate if the patient had an ICD Implant procedure prior to this admission. ��
��
Note: Timeframe does NOT include the current admission. This device is coded within Sequence
Number 3570: ICD Explant Device ID.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes-Single Chamber

2

Yes-Dual Chamber

3

Yes-Biventricular

Explanation

Field Name: Previous ICD Date

Seq No: 3260

Short Name: PrevICDDate

Core: Yes

Status: New

Harvested: Yes

Format: Date (mm/dd/yyyy)
Data Source: Client
Parent Element: Previous ICD(3250)
Parent Value: Yes-Single Chamber; Yes-Dual Chamber; Yes-Biventricular
Missing Data: Report
Valid Range: Previous ICD Date > Patient DOB and Previous ICD Date < Admission Date
Usual Range:
Description: Previous ICD Date
Definition: Indicate the date of the most recent previous ICD implant. If month and/or day are not known, enter
01.��
��
Note: In the case of multiple implants prior to this admission, code the most recent.��
Selections:
Field Name: Previous ICD Reason

Seq No: 3280

Short Name: PrevICDReason

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element: Previous ICD(3250)
Parent Value: Yes-Single Chamber; Yes-Dual Chamber; Yes-Biventricular
Missing Data: Report
Valid Range:
Usual Range:
Description: Previous ICD Reason
Definition: Indicate the previous ICD indication (reason for ICD implant).

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Selections: Coding/Sort

Selection(Choose multiple)

Explanation

1

Primary Prevention

Primary Prevention was the original
indication for patients who were at risk for
sudden death but had not suffered from a
spontaneous life-threatening ventricular
arrhythmia, syncope, or sudden cardiac
death.��

2

Syncope with Inducible VT

Syncope: Sudden loss of consciousness
with loss of postural tone, not related to
anesthesia. Inducible VT refers to
performance of electrophysiological
testing with resulting induction of VT.

3

Spontaneous Monomorphic Sustained VT

VT with a constant morphology greater
than 30 seconds in duration and/or
requiring termination due to
hemodynamic compromise in less than
30 seconds.

4

Spontaneous Polymorphic Sustained VT

VT with a constantly changing
morphology lasting greater than 30
seconds in duration and/or requiring
termination due to hemodynamic
compromise in less than 30 seconds.

5

Ventricular Fibrillation

Rapid, usually more than 300 bpm (cycle
length 180 msec or less), grossly
irregular ventricular rhythm with marked
variability in cycle length, lack of
discernible discreet QRS complex.

6

Cardiac Arrest/Arrhythmia - Etiology
Unknown

Sudden loss of consciousness requiring
cardioversion or defibrillation to restore
hemodynamic stability.

7

Syncope and High Risk Characteristics

Syncope: Sudden loss of consciousness
with loss of postural tone, not related to
anesthesia, and High Risk
Characteristics specific for non-ischemic
dilated cardiomyopathy, or ischemic heart
disease with significant ventricular
dysfunction, hypertrophic
cardiomyopathy, Brugada Syndrome,
Long QT Syndrome.��

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Selections:

8

AFib

A cardiac arrythmia arising from the
atrium with an atrial rate greater than 300
bpm and an irregular ventricular
response in the presence of conduction.
AF can be further characterized as:��
First detected AF ��
Paroxysmal AF: AF is self-terminating
within 7 days of recognized onset.��
Persistent AF: AF is not self-terminating
within 7 days, or is terminated electrically
or pharmacologically.��
Chronic AF: AF lasting more than 6
months.

Field Name: Previous ICD Implant Site

Seq No: 3290

Short Name: PrevICDsite

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element: Previous ICD(3250)
Parent Value: Yes-Single Chamber; Yes-Dual Chamber; Yes-Biventricular
Missing Data: Report
Valid Range:
Usual Range:
Description: Previous ICD Implant Site
Definition: Indicate the previous ICD implant site.
Selections: Coding/Sort

Selection(Choose one)

1

Pectoral

2

Abdominal

Field Name: Cerebrovascular Disease

Explanation

Seq No: 3310

Short Name: CVDisease

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Cerebrovascular Disease

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Definition: Indicate if the patient had cerebrovascular disease (CVD) prior to device implant, defined as any one
of the following:��
- Cerebrovascular Accident (CVA): Patient has a history of stroke, i.e., loss of neurological function
with residual symptoms at least 72 hours after onset.��
- Reversible Ischemic Neurologic Deficit (RIND): Patient has a history of loss of neurological
function with symptoms at least 24 hours after onset but with complete return of function within 72
hours.��
- Transient Ischemic Attack (TIA): Patient has a history of loss of neurological function that was
abrupt in onset but with complete return of function within 24 hours.��
- Non-invasive/invasive carotid test with greater than 75% occlusion.��
- Previous carotid artery surgery.This does not include neurological disease processes such as
metabolic and/or anoxic ischemic encephalopathy.��
Note: Patient history is defined as any time prior to the date of implant.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: Chronic Lung Disease

Explanation

Seq No: 3320

Short Name: LungDisease

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Chronic Lung Disease
Definition: Indicate if the patient has a documented history of chronic lung disease prior to this admission (i.e.
chronic obstructive pulmonary disease, emphysema, asthma, chronic bronchitis), or has been or is
currently being treated with pharmocologic therapy.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: Diabetes

Explanation

Seq No: 3330

Short Name: Diabetes

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
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Description: Diabetes
Definition: Indicate if the patient has a history of diabetes, regardless of duration of disease or need for
antidiabetic agents. It does not include gestational diabetes.��
��
Note: Patient history is defined as any time prior to the date of implant.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: Hypertension

Explanation

Seq No: 3340

Short Name: Hypertension

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Hypertension
Definition: Indicate if the patient has a history of hypertension defined as any one of the following: ��
1. History of hypertension diagnosed and treated with medication, diet and/or exercise.��
2. Blood pressure greater than 140 systolic or 90 diastolic on at least 2 occasions.��
3. Currently on antihypertensive pharmacologic therapy.��
��
Note: Patient history is defined as any time prior to the date of implant.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: Renal Failure-Dialysis

Explanation

Seq No: 3350

Short Name: Dialysis

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Renal Failure - Dialysis
Definition: Indicate if the patient received or is receiving dialysis as a result of renal failure. ��
��
Note: Patient history is defined as any time prior to the date of implant.
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Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

© 2005, American College of Cardiology Foundation

23-May-06

Explanation

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E. Diagnostic Studies

Field Name: Ejection Fraction Assessed

Seq No: 3360

Short Name: EFDone

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Ejection Fraction Assessed
Definition: Indicate if the patient's ejection fraction was assessed before or during the EP lab visit via invasive
(i.e. LV gram) or non-invasive testing (i.e. Echo).
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: EF %

Explanation

Seq No: 3370

Short Name: EFPercent

Core: Yes

Status: New

Harvested: Yes

Format: Integer
Data Source: Client
Parent Element: Ejection Fraction Assessed(3360)
Parent Value: Yes
Missing Data: Report
Valid Range: 1-99
Usual Range: 10-65
Description: Ejection Fraction %
Definition: Indicate the lowest Ejection Fraction percent that led to the decision to implant the ICD. The Ejection
Fraction percent is the percentage of blood that has emptied from the ventricle at the end of the
contraction.
Selections:
Field Name: EF Timeframe

Seq No: 3380

Short Name: EFTimeframe

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element: Ejection Fraction Assessed(3360)
Parent Value: Yes
Missing Data: Report
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Valid Range:
Usual Range:
Description: Ejection Fraction Timeframe
Definition: Indicate the timeframe of the Ejection Fraction percent that led to the decision to implant the ICD.
Selections: Coding/Sort

Selection(Choose one)

Explanation

1

0 to 1 month

0 to 1 month (up to 30 days)

2

1 to 2 months

1 to 2 months (31-60 days)

3

2 to 3 months

2 to 3 months (61-90 days)

4

3 to 6 months

3 to 6 months (91-180 days)

5

6 to 12 months

6 to 12 months (181-365 days)

6

Greater than 12 months

Greater than 12 months (366 days and
greater)

Field Name: Electrophysiology Study Done

Seq No: 3390

Short Name: EPStudy

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Electrophysiology Study Done
Definition: Indicate if the patient had an EP Study prior to the ICD implant.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: EPS Timeframe

Explanation

Seq No: 3400

Short Name: EPSTimeframe

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element: Electrophysiology Study Done(3390)
Parent Value: Yes
Missing Data: Report
Valid Range:
Usual Range:
Description: Electrophysiology Study Timeframe
Definition: Indicate the timeframe of the most recent Electrophysiology study.

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Selections: Coding/Sort

Selection(Choose one)

Explanation

1

0 to 1 month

0 to 1 month (up to 30 days)

2

1 to 2 months

1 to 2 months (31-60 days)

3

2 to 3 months

2 to 3 months (61-90 days)

4

3 to 6 months

3 to 6 months (91-180 days)

5

6 to 12 months

6 to 12 months (181-365 days)

6

Greater than 12 months

Greater than 12 months (366 days and
greater)

Field Name: EPS Findings

Seq No: 3410

Short Name: EPSFindings

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element: Electrophysiology Study Done(3390)
Parent Value: Yes
Missing Data: Report
Valid Range:
Usual Range:
Description: EPS Findings
Definition: Indicate the findings associated with the most recent Electrophysiology Study. If "No Arrythmias
Induced" is selected, no other selections may be chosen.
Selections: Coding/Sort

Selection(Choose multiple)

0

No Arrythmias Induced

1

VT Induced

2

Non-sustained VT

3

Sustained Monomorphic

4

Sustained Polymorphic

5

Ventricular Flutter Induced

6

Ventricular Fibrillation Induced

7

Results Unattainable

Field Name: QRS Duration

Explanation

The results of the EP Study could not be
obtained or located.
Seq No: 3420

Short Name: QRSDuration

Core: Yes

Status: New

Harvested: Yes

Format: Integer
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range: 10-300

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Usual Range: 20-250
Description: QRS Duration
Definition: Indicate the patient's QRS duration in milliseconds from simultaneous (preferably 3 or more) ECG
leads, including I, II, and VI, from the onset to the termination of the QRS.��
��
Note: Indicate the most recent EKG findings prior to the ICD implant.
Selections:
Field Name: PR Interval Attainable

Seq No: 3429

Short Name: PRIntervalAtt

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: PR Interval Attainable
Definition: Indicate if the patient's PR Interval was attainable. No should be answered when a patient has Afib,
a greater than 1st Degree Heart block or has a Ventricular Paced rhythm.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: PR Interval

Explanation

Seq No: 3430

Short Name: PRInterval

Core: Yes

Status: New

Harvested: Yes

Format: Integer
Data Source: Client
Parent Element: PR Interval Attainable(3429)
Parent Value: Yes
Missing Data: Report
Valid Range: 10-600
Usual Range: 40-350
Description: PR Interval
Definition: Indicate the patient's longest measured time in milliseconds from onset of P wave to onset of QRS
complex in any given ECG lead.��
��
Note: Indicate the most recent EKG findings prior to the ICD implant.
Selections:
Field Name: AV Conduction

Seq No: 3440

Short Name: AVConduct

Core: Yes

Status: New
© 2005, American College of Cardiology Foundation

Harvested: Yes
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Format: Text (Categorical)

Data Source: Client

Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: AV Conduction
Definition: Indicate the patient's Atrioventricular Conduction rhythm.��
��
Note: Indicate the EKG findings leading to the decision to implant the ICD.
Selections: Coding/Sort

Selection(Choose one)

1

Normal

2

Abnormal-1st Degree Heart Block Only

3

Abnormal-Heart Block 2nd or 3rd Degree
(not paced)

4

Paced(any)

Field Name: Intraventricular Conduction

Explanation

Seq No: 3450

Short Name: IVConduct

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Intraventricular Conduction
Definition: Indicate the patient's Intraventricular Conduction.��
��
Note: Indicate the EKG findings leading to the decision to implant the ICD.

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Selections: Coding/Sort

Selection(Choose one)

1

Normal

2

Abnormal-Left Anterior Fascicular Block

3

Abnormal-Left Posterior Fascicular Block

4

Abnormal-LBBB

5

Abnormal-RBBB

6

Abnormal-Intraventricular Conduction
Delay, Nonspecific

7

Paced

8

Abnormal-Bifascicular Block (RBBB Plus
LAF)

9

Abnormal-Bifascicular Block (RBBB Plus
LPF)

Field Name: Creatinine Level

Explanation

Seq No: 3460

Short Name: Creatinine

Core: Yes

Status: New

Harvested: Yes

Format: Decimal (2,1) eg. 99.9
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range: 0.1-30
Usual Range: 0.1-9
Description: Creatinine Level
Definition: Indicate the patient's most recent preoperative Creatinine level prior to the ICD implant. The
creatinine level is measured in mg/dL.
Selections:
Field Name: BUN Level

Seq No: 3470

Short Name: BUNLevel

Core: Yes

Status: New

Harvested: Yes

Format: Integer
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range: 1-150
Usual Range: 1-80
Description: Blood Urea Nitrogen Level
Definition: Indicate the patient's most recent preoperative BUN (Blood Urea Nitrogen) level prior to the ICD
implant. The BUN level is measured in mg/dL.
Selections:

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Field Name: Sodium Level

Seq No: 3480

Short Name: NaLevel

Core: Yes

Status: New

Harvested: Yes

Format: Integer
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range: 80-160
Usual Range: 110-150
Description: Sodium Level
Definition: Indicate the patient's most recent preoperative Sodium level prior to the ICD implant. The Sodium
level is measured in mEq/L.
Selections:
Field Name: BNP Drawn

Seq No: 3485

Short Name: BNPDrawn

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: BNP Drawn
Definition: Indicate if the patient had a preoperative BNP (B-type Natriuretic Peptide) drawn prior to the ICD
implant.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: BNP Level

Explanation

Seq No: 3490

Short Name: BNPLevel

Core: Yes

Status: New

Harvested: Yes

Format: Integer
Data Source: Client
Parent Element: BNP Drawn(3485)
Parent Value: Yes
Missing Data: Report
Valid Range: 1-5000
Usual Range: 1-2000
Description: BNP Level
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Definition: Indicate the patient's most recent preoperative BNP (B-type Natriuretic Peptide) prior to the
ICD implant. The BNP is measured in pg/mL.
Selections:
Field Name: Systolic BP

Seq No: 3500

Short Name: SystolicBP

Core: Yes

Status: New

Harvested: Yes

Format: Integer
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range: 60-250
Usual Range: 70-200
Description: Systolic Blood Pressure
Definition: Indicate the patient's systolic blood pressure on day of implant prior to sedation. Measured
in mm-Hg.
Selections:

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F. ICD Procedure(s)

Field Name: ICD Indication	

Seq No: 3505

Short Name: ICDIndication	

Core: Yes

Status: New	

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Illegal
Valid Range:
Usual Range:
Description: ICD Indication
Definition: Indicate the reason for the first ICD implantation in this patient's lifetime.
Selections: Coding/Sort

Selection(Choose one)

Explanation

1

Primary Prevention

Primary prevention is an indication for
patients who are at risk for sudden death
but have not yet suffered from a
spontaneous life-threatening ventricular
arrhythmia, syncope, or sudden cardiac
death. (This includes patients who have
never experienced syncope or cardiac
arrest but have inducible ventricular
tachycardia during electrophysiologic
testing for risk stratification.)��

2

Secondary Prevention	

Secondary prevention is an indication for
patients who have already experienced a
spontaneous life-threatening ventricular
arrhythmia, a cardiac arrest, or
unexplained syncope with workup
suggesting a high probability that a
ventricular tachyarrythmia was the cause
of the syncope.

Field Name: Reason(s) for Re-implantation

Seq No: 3506

Short Name: ReImpReason

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element: Previous ICD(3250)
Parent Value: Yes-Single Chamber; Yes-Dual Chamber; Yes-Biventricular
Missing Data: Report
Valid Range:
Usual Range:
Description: Reason(s) for Re-implantation

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Definition: Indicate the reason(s) why device was re-implanted.��
��
Note: Applicable only if Sequence Number 3250: Previous ICD, is "Yes".
Selections: Coding/Sort

Selection(Choose multiple)

Explanation

1

End of Battery Life

The manufacturer's designation that the
pulse generator battery has reached the
end of its service life.

2

Device Upgrage

Replacement of a pulse generator with a
model with additional pacing capabilities
such as an upgrade from a single to a
dual chamber device, or the replacement
of a non-CRT device with a CRT device.

3

Device Infection

Replacement of a device because of an
infection involving a previously implanted
device

4

Device Malfunction

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5

Device Under Manufacturer
Advisory/Recalled

A device model recognized by the
manufacturer as demonstrating a
recurring performance failure resulting in
an advisory letter to physicians. This
may or may not reach the level of an FDA
designated recall.

Field Name: Mult ICDs implanted during admit
Short Name: MultipleICDs

Seq No: 3507
Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Multiple ICDs implanted during this admission
Definition: Indicate if multiple ICD devices were implanted during the current admission.��
��
Note: This field is meant to capture whether an ICD was implanted AND explanted during the current
admission. Code "No" if the patient had only one implant during the current admission.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

© 2005, American College of Cardiology Foundation

23-May-06

Explanation

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Field Name: Reason for Device Repl during admit	
Short Name: DevRepReason	

Seq No: 3508
Core: Yes

Status: New	

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element: Mult ICDs implanted during admit(3507)
Parent Value: Yes
Missing Data: Report
Valid Range:
Usual Range:
Description: Reason(s) for device replacement during this admission
Definition: Indicate the reason(s) for multiple implants during the current admission.��
��
Note: Applicable only if Sequence Number 3507: Multiple ICDs implated during this admission, is
"Yes".
Selections: Coding/Sort

Selection(Choose multiple)

Explanation

1

Device Upgrade

Replacement of a pulse generator with a
model with additional pacing capabilities
such as an upgrade from a single to a
dual chamber device, or the replacement
of a non-CRT device with a CRT device.

2

Device Infection

Replacement of a device because of an
infection involving a previously implanted
device

3	

Device Malfunction

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4

Device Under Manufacturer 	
Advisory/Recalled	

A device model recognized by the
manufacturer as demonstrating a
recurring performance failure resulting in
an advisory letter to physicians. This
may or may not reach the level of an FDA
designated recall.

Field Name: Implant Operator UPIN

Seq No: 3510

Short Name: DrUpin

Core: Yes

Status: New

Harvested: Yes

Format: Text (6)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
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Usual Range:
Description: Implant Operator's Unique Physician Identification Number
Definition: Indicate the implanting physician's (U)nique (P)hysician (I)dentification (N)umber. UPINs,
assigned by CMS, are used to uniquely identify physicians for Medicare billing purposes and
may contain any letter or number character combination. The UPIN should be specified for
the physician implanting the device, not the physician placing the leads. Implanting physician
is determined by the individual institution.
Selections:
Field Name: Implant Operator NPI

Seq No: 3515

Short Name: DrNPI

Core: Yes

Status: New

Harvested: Yes

Format: Text (10)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Implant Operator's National Provider Identifier
Definition: Indicate the physician's (N)ational (P)rovider (I)dentifier. NPIs, assigned by CMS, are used
to uniquely identify physicians for Medicare billing purposes. The NPI should be specified
for the physician implanting the device, not the physician placing the leads.
Selections:
Seq No: 3520

Field Name: Implant Operator First Name

Core: Yes

Short Name: DrGiven

Harvested: Yes

Status: New
Format: Text (50)
Data Source: Automatic
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Implant Operator's First Name
Definition: Indicate the implant operator's first name.
Selections:
Field Name: Implant Operator Middle Name

Seq No: 3525

Short Name: DrMiddle

Core: Yes

Status: New

Harvested: Yes

Format: Text (50)
Data Source: Automatic
Parent Element:
Parent Value:
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Missing Data: Report
Valid Range:
Usual Range:
Description: Implant Operator's Middle Name
Definition: Indicate the implant operator's middle name or middle initial.
Selections:
Field Name: Implant Operator Last Name

Seq No: 3530

Short Name: DrSurname

Core: Yes

Status: New

Harvested: Yes

Format: Text (50)
Data Source: Automatic
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Implant Operator's Last Name
Definition: Indicate the implant operator's last name.
Selections:
Field Name: ICD Type

Seq No: 3540

Short Name: ICDType

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: ICD Type
Definition: Indicate the type of ICD implanted.
Selections: Coding/Sort

Selection(Choose one)

1

Single Chamber

2

Dual Chamber

3

Biventricular

Field Name: LV Lead Implantation Method

Explanation

Seq No: 3550

Short Name: LeadMethod

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client

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Parent Element: ICD Type(3540)
Parent Value: Biventricular
Missing Data: Report
Valid Range:
Usual Range:
Description: LV Lead Implantation Method
Definition: Indicate the method for implanting the LV lead.
Selections: Coding/Sort

Selection(Choose one)

1

Coronary Sinus

2

Epicardial Lead

3

Other

Explanation

Field Name: ICD Manufacturer

Seq No: 3560

Short Name: ICDManu

Core: Yes

Status: New

Harvested: No

Format: Text (100)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: No action
Valid Range:
Usual Range:
Description: ICD Manufacturer
Definition: Indicate the manufacturer of the implanted or explanted ICD.
Selections:
Field Name: ICD Model Name

Seq No: 3561

Short Name: ICDName

Core: Yes

Status: New

Harvested: No

Format: Text (100)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: No action
Valid Range:
Usual Range:
Description: ICD Model Name
Definition: Indicate the model name of the implanted or explanted ICD.
Selections:
Field Name: ICD Model Number

Seq No: 3562

Short Name: ICDNum

Core: Yes

Status: New

© 2005, American College of Cardiology Foundation

Harvested: No

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Format: Text (100)

Data Source: Client

Parent Element:
Parent Value:
Missing Data: No action
Valid Range:
Usual Range:
Description: ICD Model Number
Definition: Indicate the model number of the implanted or explanted ICD.
Selections:
Field Name: ICD Implant Device ID

Seq No: 3565

Short Name: ICDImplID

Core: Yes

Status: New

Harvested: Yes

Format: Integer (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: ICD Implant Device ID
Definition: Indicate the unique ACC assigned identification number associated with the implanted
device. The ACC will assign a unique identification number for each unique ICD device
manufacturer, model and model number. The list of ICDs will be maintained by the ACC
and added to the data entry tool as each new device receives FDA approval. Third party
software vendors certified by the ACC will be required to download and import the ICD
master list so that newly approved devices can be specified and submitted to the ACC. Only
one ICD Implant Device can be specified.Note: In the event of multiple implantations, code
the final/last device implanted during the current admission.
Selections:
Field Name: ICD Implant Serial Number

Seq No: 3566

Short Name: ICDImplSerNo

Core: Yes

Status: New

Harvested: Yes

Format: Text (100)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: ICD Implant Serial Number
Definition: Indicate the ICD Device Serial Number associated with the implanted device.
Selections:
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Field Name: ICD Explant Device ID

Seq No: 3570

Short Name: ICDExplID

Core: Yes

Status: New

Harvested: Yes

Format: Integer (Categorical)
Data Source: Client
Parent Element: Previous ICD(3250)
Parent Value: Yes-Single Chamber; Yes-Dual Chamber; Yes-Biventricular
Missing Data: Report
Valid Range:
Usual Range:
Description: ICD Explant Device ID
Definition: Indicate the unique ACC assigned identification number associated with the explanted
device. The ACC will assign a unique identification number for each unique ICD device
manufacturer, model and model number. The list of ICDs will be maintained by the ACC
and added to the data entry tool as each new device receives FDA approval. Third party
software vendors certified by the ACC will be required to download and import the ICD
master list so that newly approved devices can be specified and submitted to the ACC. Only
one ICD Explant Device can be specified.��
��
Note(1): Applicable only if Sequence Number 3250: Previous ICD, is "Yes". The intent of
this field is to record the device in the patient at the time of admission for the current hospital
stay.��
Note(2): This field is NOT to be used in the event of multiple implantations (Sequence
Number 3507:Multiple ICDs implanted during this admission, is "Yes").
Selections:
Field Name: ICD Explant Serial Number

Seq No: 3571

Short Name: ICDExplSerNo

Core: Yes

Status: New

Harvested: Yes

Format: Text (100)
Data Source: Client
Parent Element: Previous ICD(3250)
Parent Value: Yes-Single Chamber; Yes-Dual Chamber; Yes-Biventricular
Missing Data: Report
Valid Range:
Usual Range:
Description: ICD Explant Serial Number
Definition: Indicate the ICD Device Serial Number associated with the explanted device.
Selections:

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G. Adverse Events

Field Name: Available Adverse Events

Seq No: 3575

Short Name: AvailAdvEvent

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Automatic
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Available Events
Definition: Indicate the Adverse Events that were downloaded from the ACC website and imported into the ICD
data collection tool. This element will be used to determine if the participant has the right adverse
events in the ICD data collection tool for every admission.
Selections:
Field Name: Adverse Events Exist

Seq No: 3580

Short Name: AdvEventExists

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Illegal
Valid Range:
Usual Range:
Description: Adverse Events Exist
Definition: Indicate if the patient had any adverse events during or after the EP lab visit up until discharge. If
"Yes" then complete the Adverse Events section.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: Adverse Event

Explanation

Seq No: 3581

Short Name: AdvEvent

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element: Adverse Events Exist(3580)
Parent Value: Yes
Missing Data: Report
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Valid Range:
Usual Range:
Description: Adverse Event
Definition: Indicate the Adverse Event that occurred during or after the EP lab visit up until discharge.
The same adverse event can be repeated with a different adverse event date.��
��
Note: The initial set of Adverse Events that should be collected are documented in Appendix
A of the data dictionary. These Adverse Events may be updated periodically by the ACC.
When the Adverse Events have been updated, participants utilizing non-ACC software will
be instructed to download and import the latest version of Adverse Event file into their data
collection tool.
Selections:
Field Name: Adverse Event Date

Seq No: 3583

Short Name: AdvEventDate

Core: Yes

Status: New

Harvested: Yes

Format: Date (mm/dd/yyyy)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range: Adverse Event Date >= Date of Implant and Adverse Event Date <= Date of Discharge
Usual Range:
Description: Adverse Event Date
Definition: Indicate the date that the Adverse Event occurred.
Selections:

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H. Discharge

Field Name: CABG During This Admission

Seq No: 3590

Short Name: CABGProc

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: CABG During This Admission
Definition: Indicate if the patient had a CABG (Coronary Artery Bypass Graft Surgery) during the current
admission.��
��
Note: If multple CABGs are performed during this admission, code the date of the CABG performed
closest to the date of implant.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: CABG Date

Explanation

Seq No: 3600

Short Name: CABGDate

Core: Yes

Status: New

Harvested: Yes

Format: Date (mm/dd/yyyy)
Data Source: Client
Parent Element: CABG During This Admission(3590)
Parent Value: Yes
Missing Data: Report
Valid Range: CABG Date >= Admission Date and CABG Date <= Discharge Date
Usual Range:
Description: CABG During This Admission - Date
Definition: Indicate the date Coronary Artery Bypass Graft (CABG) Surgery was performed during the current
admission.
Selections:
Field Name: PCI During This Admission

Seq No: 3610

Short Name: PCIProc

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:

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Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: PCI During This Admission
Definition: Indicate if the patient had a PCI during this admission.��
��
Note: If multiple PCIs are performed during this admission, code the date of the PCI performed
closest to the date of implant.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: PCI Date

Explanation

Seq No: 3620

Short Name: PCIDate

Core: Yes

Status: New

Harvested: Yes

Format: Date (mm/dd/yyyy)
Data Source: Client
Parent Element: PCI During This Admission(3610)
Parent Value: Yes
Missing Data: Report
Valid Range: PCIDate >= Admission Date and PCIDate <= Discharge Date
Usual Range:
Description: PCI During This Admission - Date
Definition: Indicate the date PCI was performed during the current admission.
Selections:
Field Name: Vital Status

Seq No: 3630

Short Name: VitalStatus

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Vital Status
Definition: Indicate if the patient expired during the hospital stay. If "Yes," indicate the cause of death.
Selections: Coding/Sort

Selection(Choose one)

1

Alive

2

Deceased-Cardiac Death

3

Deceased-Non-Cardiac Death

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Field Name: Date of Death This Admit

Seq No: 3640

Short Name: DeathDate

Core: Yes

Status: New

Harvested: Yes

Format: Date (mm/dd/yyyy)
Data Source: Client
Parent Element: Vital Status(3630)
Parent Value: Deceased-Cardiac Death; Deceased-Non-Cardiac Death
Missing Data: Report
Valid Range: Date of Death This Admit >=Date of Implant and Date of Death This Admit <= Discharge Date
Usual Range:
Description: Date of Death This Admit
Definition: Indicate the date the patient expired during this hospitalization.
Selections:
Field Name: Death in Lab

Seq No: 3645

Short Name: DeathInLab

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element: Vital Status(3630)
Parent Value: Deceased-Cardiac Death; Deceased-Non-Cardiac Death
Missing Data: Report
Valid Range:
Usual Range:
Description: Death In Lab
Definition: Indicate if the patient's death occurred in the lab where the device was implanted
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

Field Name: Date of Discharge

Explanation

Seq No: 3650

Short Name: DischDate

Core: Yes

Status: New

Harvested: Yes

Format: Date (mm/dd/yyyy)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Illegal
Valid Range: Discharge Date >= Date of Implant and Discharge Date >= Admission Date
Usual Range:
Description: Date of Discharge
Definition: Indicate the patient's date of discharge.
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Selections:

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I. Discharge Medications

Field Name: Discharge Medication

Seq No: 3660

Short Name: Medication

Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Automatic
Parent Element: Vital Status(3630)
Parent Value: Alive
Missing Data: Illegal
Valid Range:
Usual Range:
Description: Discharge Medication
Definition: Indicates the discharge medication.��
��
Note: The initial set of discharge medications that should be collected are documented in Appendix
B of the data dictionary. These medications may be updated periodically by the ACC. When the
discharge medications have been updated, participants utilizing non-ACC software will be instructed
to download and import the latest version of medication file into their data collection tool.
Selections:
Field Name: Discharge Medication Prescribed
Short Name: MedPresc

Seq No: 3665
Core: Yes

Status: New

Harvested: Yes

Format: Text (Categorical)
Data Source: Client
Parent Element:
Parent Value:
Missing Data: Report
Valid Range:
Usual Range:
Description: Discharge Medication Prescribed
Definition: Indicate if discharge medication was prescribed, not prescribed, contraindicated or blinded.��
��
Note: "Blinded" should be specified if the patient was in a research study and the prescribing of this
specific medication is unknown.
Selections: Coding/Sort

Selection(Choose one)

0

No

1

Yes

2

Contraindicated

3

Blinded

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Explanation

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Adverse Events

Field Name: Cardiac Arrest

Adverse Event Seq No: ae001

Adverse Event ID: 1
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced a cardiac arrest as documented by sudden cessation of
cardiac activity so that the patient became unresponsive, with no normal breathing and no
signs of circulation.
Field Name: Drug Reaction

Adverse Event Seq No: ae002

Adverse Event ID: 2
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced a drug reaction as documented by anaphylaxis, rash, etc.
Field Name: Cardiac Perforation

Adverse Event Seq No: ae003

Adverse Event ID: 3
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced a cardiac perforation as documented by migration of
pacing or defibrillator lead to epicardial surface, resulting in pain, pericardial effusion, failure
to capture, capture of diaphragm, phrenic nerve, or intercostals muscle of sufficient
magnitude to require repositioning.
Field Name: Cardiac Valve Injury

Adverse Event Seq No: ae004

Adverse Event ID: 4
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced a cardiac valve injury as documented by manipulation of
pacing or defibrillating leads that may tear a valve leaflet or chordae rendinae (usually
manifests as a new regurgitant mumur appearing after the procedure). �
Field Name: Conduction Block

Adverse Event Seq No: ae005

Adverse Event ID: 5
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced a conduction block as documented by manipulation of
pacing or defibrillating leads that may injure parts of the specialized cardiac conducting
system. (Usually manifest as a new RBBB or new noset of complete heart block in a person
with preexisting LBBB).
Field Name: Coronary Venous Dissection

Adverse Event Seq No: ae006

Adverse Event ID: 6
Effective Date: 01/01/2004

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Definition: Indicate if the patient experienced a coronary venous dissection as documented by
manipulation of pacing or defibrillating leads in the coronary sinus (CS) may result in a tear
of the CS endothelium, with dissection into the CS wall. This may occasionally result in
perforation of the CS.
Field Name: Hematoma

Adverse Event Seq No: ae007

Adverse Event ID: 7
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced hematoma resulting in reoperation or transfusion.
Field Name: Lead Dislodgement

Adverse Event Seq No: ae008

Adverse Event ID: 8
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced a lead dislodgement as documented by movement of lead
sufficient to require repositioning.
Field Name: Hemothorax

Adverse Event Seq No: ae009

Adverse Event ID: 9
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced a hemothorax as documented by accumulation of blood in
thorax.
Field Name: Pneumothorax

Adverse Event Seq No: ae010

Adverse Event ID: 10
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced a pneumothorax as documented by air in thorax sufficient
to require chest tube.
Field Name: Peripheral Nerve Injury

Adverse Event Seq No: ae011

Adverse Event ID: 11
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced peripheral nerve injury as documented by sensory or
motor loss of peripheral nerve function. This may result from external nerve compression as
a result of positioning during an implantationprocedure, internal compression (e.g.
secondary to hematoma formation) or direct nerve.
Field Name: Peripheral Embolus

Adverse Event Seq No: ae012

Adverse Event ID: 12
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced a peripheral embolus as documented by acute occlusion
of an artery resulting from embolization of a cardiac or proximal arterial thrombus.
Field Name: Phlebitis - Superficial

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Adverse Event ID: 13
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced superficial phlebitis as documented by signs of superficial
venous inflammatio, such as local erythema, tenderness or swelling.
Field Name: Phlebitis - Deep

Adverse Event Seq No: ae014

Adverse Event ID: 14
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced deep phlebitis as documented by occlusion of deep vein
resulting in extremity swelling, plus or minus signs of inflammation.
Field Name: TIA

Adverse Event Seq No: ae015

Adverse Event ID: 15
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced a TIA as documented by loss of neurological function that
was abrupt in onset but with complete return of function within 24 hours.
Field Name: CVA/Stroke

Adverse Event Seq No: ae016

Adverse Event ID: 16
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced a cerebrovascular accident (CVA) as documented by a
central neurological deficit persisting for > 72 hours.
Field Name: MI

Adverse Event Seq No: ae017

Adverse Event ID: 17
Effective Date: 01/01/2004

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Definition: Indicate if the patient experienced an MI during the EP lab visit or after lab visit until
discharge (or before any subsequent lab visits) as documented by:�
Definitions: NON ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI)�
The patient was hospitalized for a myocardial infarction documented in the medical record.�
AT LEAST ONE OF THE FOLLOWING BIOCHEMICAL INDICATORS for detecting
myocardial necrosis must be present (see below for a definition of Reference Control Limits):�
1) Troponin T or I:�
a) Maximal concentration of troponin T or I > the MI decision limit on at least one occasion
during the first 24 hours after the index clinical event.�
2) CK-MB:�
a) Maximal value of CK-MB > 2 x the upper limit of normal on one occasion during the first
hours after the index clinical event. OR�
b) Maximal value of CK-MB, preferable CK-MB mass, > upper limit of normal on two
successive samples.�
3) Total CK:�
a) In the absence of availability of a troponin or CK-MB assay, total CK > 2 x the upper
limit of normal, or the B fraction of CK may be employed, but these last two biomarkers are
considerably less satisfactory than CK-MB.�
�
AND ONE OF THE FOLLOWING:�
1) Either ST segment depression or T wave abnormalities; or�
2) Ischemic symptoms in the presence or absence of chest discomfort. Ischemic symptoms
may include:�
a) unexplained nausea and vomiting; or�
b) persistent shortness of breath secondary to left ventricular failure; or�
c) unexplained weakness, dizziness, lightheadedness, or syncope.�
�
ST ELEVATION MYOCARDIAL INFARCTION (STEMI)�
Indicate whether the patient was hospitalized for an ST Elevation Myocardial Infarction
(STEMI) documented in the medical record.�
AT LEAST ONE OF THE FOLLOWING BIOCHEMICAL INDICATORS for detecting
myocardial necrosis must be present (see below for a definition of Reference Control Limits):�
1) Troponin T or I:�
a) Maximal concentration of troponin T or I > the MI decision limit on at least one occasion
during the first 24 hours after the index clinical event.�
2) CK-MB:�
a) Maximal value of CK-MB > 2 x the upper limit of normal on one occasion during the first
hours after the index clinical event; OR�
b) Maximal value of CK-MB, preferable CK-MB mass, > upper limit of normal on two
successive samples.�
3) Total CK�
a) In the absence of availability of a troponin or CK-MB assay, total CK > 2 x the upper
limit of normal, or the B fraction of CK may be employed, but these last two biomarkers are
considerably less satisfactory than CK-MB.�
�
AND ONE OF THE FOLLOWING ECG CHANGES:�
1) ST-segment elevation: New or presumed new ST segment elevation at the J point in two
or more continguous leads with the cut-off points >=0.2 mV in leads V1, V2, or V3, or >=0.1
mV in other leads; OR�
2) Development of any Q wave in leads V1 through V3, or the development of a Q-wave > or
= to 30 ms (0.03s) in leads I, II, aVL, aVF, V4, V5, or V6. (Q wave changes must be
present in any two continguous leads, and be > or = to 1mm in depth.)�
�
Defining Reference Control Values (MI Diagnostic Limit and Upper Limit of Normal):�
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Definition: Reference values must be determined in each laboratory by studies using specific assays
with appropriate quality control, as reported in peer-reviewed journals. Acceptable
imprecision (coefficient of variation) at the 99th percentile for each assay should be defined
as < or = to 10%. Each individual laboratory should confirm the range of reference values in
their specific setting.
Field Name: Pericardial Tamponade

Adverse Event Seq No: ae018

Adverse Event ID: 18
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced fluid in the pericardial space compromising cardiac filling,
and requiring intervention as documented by either: 1) Echo showing pericardial fluid and
signs of tamponade such as right heart compromise, or 2) Systemic hypotension due to
pericardial fluid compromising cardiac function.
Field Name: AV Fistula

Adverse Event Seq No: ae019

Adverse Event ID: 19
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced an AV fistula as documented by a connection between the
access artery and the accompanying vein that is demonstrated by arteriography or
ultrasound and most often characterized by a continuous bruit.
Field Name: Infection Related to Device

Adverse Event Seq No: ae020

Adverse Event ID: 20
Effective Date: 01/01/2004

Expiration Date:

Definition: Indicate if the patient experienced an infection related to the device.

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Medications

Field Name: ACE-Inhibitor (any)

Medication Seq No: m001

Category: Ace Inhibitor

Medication ID: 1

Effective Date: 01/01/2004
Field Name: Amiodarone

Expiration Date:
Medication Seq No: m002

Category: Antiarrhythmic Agent

Medication ID: 2

Effective Date: 01/01/2004
Field Name: Disopyramide

Expiration Date:
Medication Seq No: m003

Category: Antiarrhythmic Agent

Medication ID: 3

Effective Date: 01/01/2004
Field Name: Dofetilide

Expiration Date:
Medication Seq No: m004

Category: Antiarrhythmic Agent

Medication ID: 4

Effective Date: 01/01/2004
Field Name: Flecainide

Expiration Date:
Medication Seq No: m005

Category: Antiarrhythmic Agent

Medication ID: 5

Effective Date: 01/01/2004
Field Name: Mexiletine

Expiration Date:
Medication Seq No: m006

Category: Antiarrhythmic Agent

Medication ID: 6

Effective Date: 01/01/2004
Field Name: Procainamide

Expiration Date:
Medication Seq No: m007

Category: Antiarrhythmic Agent

Medication ID: 7

Effective Date: 01/01/2004
Field Name: Propafenone

Expiration Date:
Medication Seq No: m008

Category: Antiarrhythmic Agent

Medication ID: 8

Effective Date: 01/01/2004
Field Name: Quinidine

Expiration Date:
Medication Seq No: m009

Category: Antiarrhythmic Agent

Medication ID: 9

Effective Date: 01/01/2004

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Field Name: Sotalol

Medication Seq No: m010

Category: Antiarrhythmic Agent

Medication ID: 10

Effective Date: 01/01/2004
Field Name: Other Anti. Arrhy.

Expiration Date:
Medication Seq No: m011

Category: Antiarrhythmic Agent

Medication ID: 11

Effective Date: 01/01/2004
Field Name: Hydralazine

Expiration Date:
Medication Seq No: m012

Category: Antihypertensive

Medication ID: 12

Effective Date: 01/01/2004
Field Name: ARB (any)

Expiration Date:
Medication Seq No: m013

Category: ARB

Medication ID: 13

Effective Date: 01/01/2004
Field Name: ASA

Expiration Date:
Medication Seq No: m014

Category: ASA

Medication ID: 14

Effective Date: 01/01/2004
Field Name: Beta-Blocker (any)

Expiration Date:
Medication Seq No: m015

Category: Beta Blocker

Medication ID: 15

Effective Date: 01/01/2004
Field Name: Diltiazem

Expiration Date:
Medication Seq No: m016

Category: Calcium Channel Blocker

Medication ID: 16

Effective Date: 01/01/2004
Field Name: Verapamil

Expiration Date:
Medication Seq No: m017

Category: Calcium Channel Blocker

Medication ID: 17

Effective Date: 01/01/2004
Field Name: Other CCB

Expiration Date:
Medication Seq No: m018

Category: Calcium Channel Blocker

Medication ID: 18

Effective Date: 01/01/2004
Field Name: Coumadin

Expiration Date:
Medication Seq No: m019

Category: Coumadin

© 2005, American College of Cardiology Foundation

Medication ID: 19

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Effective Date: 01/01/2004
Field Name: Digoxin

Expiration Date:
Medication Seq No: m020

Category: Digoxin

Medication ID: 20

Effective Date: 01/01/2004
Field Name: Diuretic (any)

Expiration Date:
Medication Seq No: m021

Category: Diuretic

Medication ID: 21

Effective Date: 01/01/2004
Field Name: Nitroglycerin SL, PRN

Expiration Date:
Medication Seq No: m022

Category: Nitrate

Medication ID: 22

Effective Date: 01/01/2004
Field Name: Nitroglycerin Long Acting

Expiration Date:
Medication Seq No: m023

Category: Nitrate

Medication ID: 23

Effective Date: 01/01/2004
Field Name: Clopidogrel

Expiration Date:
Medication Seq No: m024

Category: Platelet Aggregation Inhibitor

Medication ID: 24

Effective Date: 01/01/2004
Field Name: Ticlopidine

Expiration Date:
Medication Seq No: m025
Medication ID: 25

Category: Platelet Aggregation Inhibitor

Expiration Date:

Effective Date: 01/01/2004
Field Name: Statin (any)

Medication Seq No: m026

Category: Statin

Medication ID: 26
Expiration Date:

Effective Date: 01/01/2004

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