CMS-10151 ICD Registry Form v 2.2

A. DEMOGRAPHICS
Last Name
2030

SSN

2000

2010

:

First Name

:

-

Birth Date

2050

Race:
(check all that apply)

:

□ SSN N/A2031

-

2040

Patient ID

mm / dd / yyyy

□ White2070

Sex

2060

:

(auto)
O Female

2045

Other ID

:

:

Patient Zip Code

2065

□

:

2066

Zip Code N/A

□ American Indian/Alaskan Native2073

□ Asian2072 If Yes, □ Asian Indian2080 □ Chinese2081 □ Filipino2082 □ Japanese2083 □ Korean2084 □ Vietnamese2085 □ Other2086
□ Native Hawaiian/Pacific Islander2074 If Yes, □ Native Hawaiian2090 □ Guamanian or Chamorro2091 □ Samoan2092 □ Other Island2093
2076

: O No

O Yes

If Yes, Ethnicity Type:

□ Puerto Rican2101

(check all that apply)

□ Cuban2102

□ Other Hispanic, Latino or Spanish Origin2103

OF CARE (ADMISSION)

Arrival Date

3000

: mm / dd / yyyy
3005

Health Insurance

O No

:

If Yes, Payment Source

3010

Reason for Admission

3040

: O Admitted for this procedure

O Heart Failure

O Other

O Yes

:

(Select all that apply)

3015

:

O Male

□ Mexican, Mexican-American, Chicano2100

HIC #

Middle Name

□ Black/African American2071

Hispanic or Latino Ethnicity

B. EPISODE

2020

:

□ Private Health Insurance
□ Medicare
□ Medicaid
□ Military Health Care
□ State-Specific Plan (non-Medicaid) □ Indian Health Service □ Non-US Insurance

:
3020

Research Study
C. HISTORY

AND
4000

Heart Failure

: O No

If Yes, Study Name3025, Patient ID3030:

O Yes

RISK FACTORS
:

O No

If Yes, NYHA Functional Classification
O Class I

4165

If Yes, Syndrome Type

4010

O Class II

Syndromes w/Risk of Sudden Death
4170

:

O Class III

:

O No

4225

:

4230

:

O Yes

O Yes

:
:
4250

:

O No

O Yes

O No

O Yes

mm / dd / yyyy
O No

O Yes

O No

O Yes

%

O Brugada syndrome

If Yes, Timeframe

4190

: O <3 months

O Not Attempted

O Yes

O >= 3 months

O Inability to Complete

If Yes, Timeframe4205: O <3 months
O Not Attempted

O >= 3 months

O Inability to Complete

If Yes, VFib Arrest

4235

:
4240

If Yes, Bradycardia Arrest

:

O No

O Yes

O No

O Yes

O No

O Yes

mm / dd / yyyy

If Yes, Occurred Post Cardiac Surgery4255:(w/in 48 hrs) O No

If Yes, VT Type

:

Familial Hx of Non-Ischemic Cardiomyopathy4180: O No

O Yes (for 3 months) O Not Documented

:

4275

mm / dd / yyyy à

:

:

If Yes, Bradycardia Dependent

:

4160

O Yes

O Yes (for 3 months) O Not Documented

4210

If Yes, Most Recent VT Date

If Yes, Most Recent LVEF

4155

O Yes

:
O No

Therapy Maximum Dose

If Yes, Most Recent Arrest Date

O Yes
O No

4200

Ventricular Tachycardia

O Class IV

O Short QT syndrome

Non-Ischemic Cardiomyopathy :
If Yes, Guideline Directed Medical

4245

O No

O Idiopathic/Primary VT/VF

4195

If Yes, VTach Arrest

:

O Long QT syndrome

Therapy Maximum Dose

4220

4150

O Catecholaminergic polymorphic VT

Ischemic Cardiomyopathy :
If Yes, Guideline Directed Medical

4215

LVEF Assessed

If Yes, Most Recent LVEF Date

4185

On Inotropic Support

O Yes

:

Familial Syndrome with Risk of Sudden Death4175: O No

Cardiac Arrest

□ Patient Restriction3035

,

4260

:

O Non-sustained VT

O No

O Yes
O Yes

O Monomorphic VT

If Yes, Reversible Cause4265:
If Yes, Hemodynamic Instability
O Polymorphic VT

4270

: O No

O Yes

O Monomorphic and polymorphic VT

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to average 15 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information
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documents, please contact Rosemarie Hakim.
Page 1 of 5
© 2009, American College of Cardiology Foundation 28-Sep-2016

C. HISTORY AND RISK FACTORS (CONT.)
Syncope

4280

:

Coronary Artery Disease

4285

4300

Coronary Angiography

:

O No

O Yes

O No

O Yes

:

If Yes, Performed after Most Recent Cardiac Arrest
If Yes, Results of Angiography

4305

:

4310

4290

Prior MI

O No

If Yes, Most Recent MI Date

O No

O Yes

O No

O Yes

If Yes, Revascularization Outcome

4330

Indications for Permanent Pacemaker

4315

:

O No

4320

:

Prior Cardiovascular Implantable Electronic Device

O Complete revascularization
4325

:

O No

O Yes

:
4335

:

:

If Yes, Reason Pacing Indicated4345: O Sick sinus syndrome
O Complete heart block
O Chronotropic incompetence

Candidate for Transplant
Atrial Fibrillation

4399

:

If Yes, AFib Classification

4400

O No

O Yes

:

O Yes

O No

O Yes

O No

O Yes

O Ventricular

O Both

4365

Candidate for LVAD

4370

Currently on LVAD

O Yes

:

:

O No

O Yes

O No

O Yes

O Paroxysmal (terminating spontaneously w/in 7 days)

O Long standing persistent (>1 year)

O Persistent (>7 days)

O Permanent

If Yes, Plans for Cardioversion of AFib
Paroxysmal SVT History

O Yes

O No

O No

:

4490

O No

O Mobitz Type II
O 2:1 AV Block
O Atrial lead implant for SVT discrimination

If Yes, Anticipated Requirement of >40% RV pacing4350:
:

O Significant disease

O Incomplete revascularization

O Atrial

4360

mm / dd / yyyy

(Includes previously placed)

4340

On Heart Transplant Waiting List

:

4405

:

:

O No

O Yes

O No

O Yes

O No

O Yes

O Yes

O Yes

If Yes, Class I or Class II Guideline Bradycardia Pacemaker Indication Present

4355

4295

O Nosignificant disease
O Non-revascularizable significant disease

:

If Significant disease, Revascularization Performed

If Yes, Pacing Type

:

OTHER HISTORY
Prior PCI

4495

:

If Yes, Most Recent PCI Date4500:

mm / dd / yyyy If Yes, Elective4505:

If Yes, Pre-existing Cardiomyopathy
4515

Prior CABG

4510

:

:

If Yes, Most Recent CABG Date

4520

Other Structural Abnormalities

O No

O Yes

O No

O Yes

: (Moderate to Severe) O No

O Yes

:

O Yes

4535

4540

O Yes

mm / dd / yyyy If Yes, Elective4525:

:

If Yes, Pre-existing Cardiomyopathy4530:
Primary Valvular Heart Disease

O No

If Yes, Structural Abnormality Type

O No
4545

:

O No

O Yes

O No

O Yes

O No

O Yes

O No

O Yes

(Select all that apply)

□ LV structural abnormality associated with risk for sudden cardiac arrest
□ Hypertrophic cardiomyopathy (HCM) with high risk features
□ Infiltrative
□ Arrhythmogenic right ventricular cardiomyopathy (ARVC)
□ Congenital heart disease associated with sudden cardiac arrest
Cerebrovascular Disease
4555

Diabetes Mellitus

4550

:

:

© 2009, American College of Cardiology Foundation

O No
O No

O Yes
O Yes

Currently on Dialysis

4560

Chronic Lung Disease

28-Sep-2016

:

4575

:

Page 2 of 5

D. DIAGNOSTIC STUDIES
5000

Electrophysiology Study

:

O No

O Yes

If Yes, Most Recent Electrophysiology Study Date5005:

mm / dd / yyyy

If Yes, Clinically Relevant Ventricular Arrhythmias Induced5015:

O No

ECG Performed5030:

O No

5035

If Yes, ECG Date

:

Only Ventricular Paced QRS Complexes Present
If Yes, Ventricular Paced QRS Duration

5045

:

□ Sinus

O No

O No

O Yes
msec

:

msec
O Yes

5065

□ Left Bundle Branch Block (LBBB)
□ Right Bundle Branch Block (RBBB)
:

O Yes

5055

O No

If Yes, Intraventricular Conduction Types

(Select all that apply)

O No

:

Abnormal Intraventricular Conduction5060:

Ventricular Paced

O Yes

5050

If No, QRS Duration (Non-Ventricular Paced Complex)

5105

O Yes

mm / dd / yyyy

If Yes, Was ECG Normal5040:

Atrial Rhythm5100:

□ Date Unknown5010

: (Select all that apply)

□ Delay, Nonspecific
□ Alternating RBBB and LBBB

□ AFib □ Atrial tach □ Atrial Flutter □ Sinus arrest □ Atrial paced □ Not Documented

O Yes

E. LABS
BUN6025:

mg/dL

Hemoglobin6030:

g/dL

□
□

Not Drawn

Not Drawn

F. PROCEDURE INFORMATION (COMPLETE FOR EACH LAB
Procedure Start Date/Time
Procedure Type
ICD Indication

7010

7015

7000

:

:

Premarket Clinical Trial

7020

:

6026

Sodium

□

mEq/L

Not Drawn

6036

VISIT)

Procedure End Date/Time

O Initial generator implant

O Generator change

O Primary prevention

O Secondary prevention

O No

:

6031

mm/dd/yyyy / hh:mm

:

6035

7005

mm/dd/yyyy / hh:mm

:

O Generator explant

O Lead only

O Yes

G. ICD IMPLANT / EXPLANT (COMPLETE FOR EACH LAB VISIT IN WHICH AN INITIAL GENERATOR IMPLANT, GENERATOR CHANGE, OR GENERATOR EXPLANT WAS PERFORMED)
7600,7605,7610

Operator Name

Device Implanted

7620

:

Operator NPI

:

O No

If Yes, Final Device Type
If Yes, CS/LV Lead

7630

7625

:

:

7615

:

O Yes

O Single chamber

O Dual chamber

O Implant unsuccessful

O Not attempted

O CRT-D

O S-ICD (Sub Q)

O Successfully implanted

O Previously implanted

DEVICE INFORMATION FOR IMPLANTED DEVICES
If Yes, Device ID

7635

:

7010

à IF PROCEDURE TYPE

If Yes, Serial Number

7650

If Yes, UDI

7645

:

(future)

: (Select all that apply)

□ End of expected battery life
□ Under manufacturer advisory/recalled
If Upgrade, Reason for Upgrade
Device Explanted

:

= ‘GENERATOR CHANGE’ OR ‘GENERATOR EXPLANT’

Reason(s) for Re-Implantation

7660

7640

□ Replaced at time of lead revision
□ Faulty Connector/Header

7655

:

:

O Single ICD to Dual ICD
O Not explanted

If Previously Explanted, Explant Date

7665

:

□ Upgrade
□ Device relocation

□ Infection
□ Malfunction

O ICD to CRT-D

O Explanted

O Previously explanted

mm / dd / yyyy

DEVICE INFORMATION FOR CHANGED OR EXPLANTED DEVICES
If Explanted, Device ID

7675

:

If Explanted, Serial Number
7670

Explant Treatment Recommendation

:

© 2009, American College of Cardiology Foundation

O No Re-implant

7680

:

If Explanted, UDI

7685

: (future)

O Downgrade

28-Sep-2016

Page 3 of 5

H. LEAD ASSESSMENT (COMPLETE FOR ALL LEADS, INCLUDING NEW LEADS IMPLANTED, EXISTING LEADS EXTRACTED, ABANDONED, OR REUSED)
7690,7695,7700

Operator Name

7710

Lead Counter

7715

Identification
7720

Lead ID

:

Operator NPI

7705

:

:

1

2

3

:

O New Lead
O Existing Lead

O New Lead
O Existing Lead

O New Lead
O Existing Lead

(future)

(future)

(future)

:
7725

Serial Number

:

UDI7730:
Lead Location

7735

:

O RA endocardial
O LV epicardial
O RV endocardial
O SVC/subclavian
O LV via CVS
O Subcutaneous (S-ICD)
O Subcutaneous array
O Other

O RA endocardial
O LV epicardial
O RV endocardial
O SVC/subclavian
O LV via CVS
O Subcutaneous (S-ICD)
O Subcutaneous array
O Other

O RA endocardial
O LV epicardial
O RV endocardial
O SVC/subclavian
O LV via CVS
O Subcutaneous (S-ICD)
O Subcutaneous array
O Other

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

O Extracted
O Abandoned
O Reused

O Extracted
O Abandoned
O Reused

O Extracted
O Abandoned
O Reused

COMPLETE FOR EXISTING LEADS ONLY
7740

Existing Lead Implant Date
7745

Existing Lead Status

I. INTRA

OR

:

POST-PROCEDURE EVENTS (COMPLETE

Cardiac Arrest

9000

9005

Cardiac Perforation

9010

:

:

Coronary Venous Dissection
Cardiac Tamponade
9120

FOR EACH LAB

:

Myocardial Infarction

Stroke

:

9055

9015

:

:

:

VISIT)
9140

O No

O Yes

TIA

:

O No

O Yes

Hematoma (Req re-op, evacuation or transfusion)

9180

O No

O Yes

Infection Requiring Antibiotics

O No

O Yes

Hemothorax

9205

:

9215

O No

O Yes

Pneumothorax

:

O No

O Yes

Urgent Cardiac Surgery

O No

O Yes

O No

O Yes

9250

:

9195

:

O No

O Yes

: O No

O Yes

O No

O Yes

O No

O Yes

O No

O Yes

O No

O Yes

POST-PROCEDURE EVENT(S)
9255

Set Screw Problem

Lead Dislodgement

:

9260

:

If Yes, Lead Location9265: O RA endocardial
O LV epicardial
O RV endocardial

© 2009, American College of Cardiology Foundation

O SVC/subclavian
O Subcutaneous array
O LV via CVS
O Other
O Subcutaneous (S-ICD)

28-Sep-2016

Page 4 of 5

J. DISCHARGE (COMPLETE FOR EACH EPISODE OF
10005

CABG
PCI

10015

CARE/ADMISSION)
10010

:(During this admission)

O No

O Yes

If Yes, CABG Date

(During this admission)

O No

O Yes

If Yes, PCI Date

:

Discharge Date

10100

:

10105

Discharge Status

:

10020

:

mm / dd / yyyy
mm / dd / yyyy

mm / dd / yyyy
:

O Alive

If Alive, Discharge Location

O Deceased
: O Home
O Extended care/TCU/rehab
O Other acute care hospital

O Skilled Nursing facility
O Other
O Left against medical advice (AMA)

10110

If Deceased, Death During the Procedure10120:
If Deceased, Cause of Death

O No

O Yes

10125

:

O Acute myocardial infarction
O Sudden cardiac death
O Heart failure
O Stroke
O Cardiovascular procedure
O Cardiovascular hemorrhage
O Other cardiovascular reason

O Pulmonary
O Renal
O Gastrointestinal
O Hepatobiliary
O Pancreatic
O Infection
O Inflammatory/Immunologic

O Hemorrhage
O Non-cardiovascular procedure or surgery
O Trauma
O Suicide
O Neurological
O Malignancy
O Other non-cardiovascular reason

DISCHARGE MEDICATIONS (PRESCRIBED AT DISCHARGE)
Medications prescribed at discharge are not required for patients who expired or discharged to “Other acute care Hospital,” or “AMA”.

MEDICATION

PRESCRIBED

10200

10205

YES

NO - NO REASON

NO - MEDICAL REASON

NO - PT. REASON

Aldosterone Antagonist

O

O

O

O

Antiarrhythmic Drug

O

O

O

O

Warfarin

O

O

O

O

Antiplatelet Agent

O

O

O

O

Aspirin

O

O

O

O

Apixaban

O

O

O

O

Dabigatran

O

O

O

O

Edoxaban

O

O

O

O

Rivaroxaban

O

O

O

O

ACE Inhibitor

O

O

O

O

ARB

O

O

O

O

Statin

O

O

O

O

Beta Blocker

O

O

O

O

© 2009, American College of Cardiology Foundation

28-Sep-2016

Page 5 of 5