CMS-10151 Instrument

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

ICD_v2_DataCollectionForm_GenLeads_2 1_508 compliant

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

OMB: 0938-0967

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NCDR® ICD Registry™ V2.1
Data Collection Form – Generator & Leads
A. DEMOGRAPHICS
Last Name2000: 

First Name2010:

SSN2030:             ­

□ SSN N/A2031

­

Birth Date 2050:

Middle Name2020:

Patient ID2040:                              
Sex2060:    O Male   

Hispanic or Latino Ethnicity2076:

O Female

□ White2070
□ Black/African American2071
□ American Indian/Alaskan Native2073

Race:
(check all that apply)

Other ID2045:

(auto)

O No

O Yes

□  Asian2072
□ Native Hawaiian/Pacific Islander2074

B. EPISODE OF CARE (ADMISSION)
Arrival Date3000:      

□  Zip Code NA3006

Patient Zip Code3005: 

Reason for Admission3010:   O Admitted for this procedure     

O Cardiac ­ Heart Failure    

O Cardiac ­ Other      

O Non­Cardiac

□ Private Health Insurance
□ Medicare
□ Medicaid
□ Military Health Care3023
3024
3025
□ State­Specific Plan (Non­Medicaid)
□ Indian Health Service
□ Non­US Insurance3026 □ None3027
3020

Insurance Payor(s):
(check all that apply)

3021

3022

HIC3030:
C. HISTORY AND RISK FACTORS (COMPLETE ONLY ONCE FOR EPISODES OF CARE/ADMISSIONS WITH A GENERATOR IMPLANT OR CHANGE)
Heart Failure4000:

O No

O Yes

 If Yes, Duration of Symptoms Since Initial Onset4005:
 If Yes, Prior Heart Failure Hospitalization
 If  Yes, Prior HF Hospital Timeframe
NYHA Functional Classification

4020

:

4010

:  O No

:

O No

On Heart Transplant  Waiting List

4040

O No

:

4055

: 

Atrial Fibrillation/Flutter

:    

O Class II

O Yes

O Class III

Ventricular Tachycardia

O No

:                        

 If Yes, Hemodynamic Instablility

O Class IV
4030

 If Yes, Timeframe

: O < 3 months

Syncope

O Yes

: 

Family History of Sudden Death

O Yes

:                  
4090

: 

4095

:

Syndromes w/Risk of Sudden Death

4100

:

O No

O Yes

:

 If Yes, Type

O No
4115

:     

O No

O Yes

O Permanent (> 1 year) 

O Sustained polymorphic VT

O No

O Yes 

O Unknown

O No

O Yes 

O Unknown

O No

O Yes

O Unknown 

 If Yes, Most Recent Arrest Date

O  Short QT syndrome   

O  Catecholaminergic polymorphic VT  
Previous ICD

O Yes

O Yes

O  Long QT syndrome

 If Yes, Syndrome Type4105:
4110

O No

O Unknown

O No
O Yes  O Unknown
:      
O Non­sustained VT 
O Sustained monomorphic VT

4080

 If Yes, Bradycardia Arrest

: 

O Persistent (> 7 days)    

O Sustained monomorphic and polymorphic VT 

 If Yes, VTach/VFib Arrest

4050

O >9 months

4070

 If Yes, VT Type4075:
Cardiac Arrest

O 3 to 9 months

4045

O No
O Yes
 
      
O
Paroxysmal
:
O Secondary (reversible cause)

4065

O > 9 months

O Yes

4060

 If Yes, AFib/Flutter Classification

O 3 to 9 months

O <= 6 months      O > 6 months

O Class I

Non­Ischemic Dilated Cardiomyopathy
Prior Heart Transplant

O No

4015

4025

4035

:      

O < 3 months

4085

mm/dd/yyyy

:

O  Brugada syndrome

O  Idiopathic/Primary VT/VF

O  Other

O Yes

O Single chamber      O Dual chamber      O CRT­D

 If Yes, Previous ICD Implant Site4120:
4125

O Pectoral

O  Abdominal

mm/dd/yyyy

 If Yes, Previous ICD Date

:  

 If Yes, Previous ICD Reason

4130

:

O  Primary prevention

 If Primary Prevention, Implant Decision LVEF

4135

O  Secondary prevention

:   _____________%

□

LVEF Not Available4136

 If Secondary Prevention, Reason(s) for Initial Implant: (check all that apply)

□ Cardiac Arrest/Arrhythmia­Etiology Unknown4140   □ Spontaneous Sustained VT4141 
□ Syncope with Inducible VT4143 
□ Ventricular Fibrillation4144 

□ Syncope with High Risk Characteristics4142
□ Not Documented4145

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.  The valid OMB control number for this 
information collection is 0938­0967.  The time required to complete this information collection is estimated to average fifteen (15) minutes per response, including the time to review instructions, search existing 
data resources, gather the data needed, and complete and review the information collection.  If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please 
write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4­26­05, Baltimore, Maryland 21244­1850.

© 2010 American College of Cardiology Foundation

2/23/2010

Page 1 of 5

NCDR® ICD Registry™ V2.1
Data Collection Form – Generator & Leads
Permanent Pacemaker 4150:

O No
4155

 If Yes, Pacemaker Type
Ischemic Heart Disease

:

O Yes

(Includes previously placed)

O Atrial chamber

4160

:

O No

O Ventricular chamber

Prior MI

:         

(Prior to arrival)
Prior PCI4180:                           
4190

(Prior to arrival)
:               

Prior CABG

O Yes

O No

O Yes

 If Yes, Most Recent MI Timeframe4175:    O <= 40 days        O > 40 days

O No

O Yes

 If Yes, Most Recent PCI Date4185:  

O No

O Yes

4200

:

O No

O Yes

Other Structural Abnormalities4205:

O No

O Yes

Primary Valvular Heart Disease

O CRT

O Yes

 If Yes, One Epicardial Artery >=70% Confirmed by Angiography4165:  O No
4170

O Dual chamber

 If Yes, Most Recent CABG Date

mm/dd/yyyy

4195

mm/dd/yyyy

:  

(Moderate to Severe)

 If Yes, Structural Abnormality Type(s): (check all that apply)

□ Amyloidosis4210
□ Atrial Septal Defect4211   
□ Chagas Disease4212 
□ Common Ventricle4213
4214
4215
□ Ebstein’s Anomaly
□ Giant Cell Myocarditis
□ Hypertrophic Cardiomyopathy (HCM)4216
□ Left Ventricular Aneurysm4217
□ LV Non­compaction Syndrome4218  □ Right Ventricular Dysplasia (ARVD)4219 □ Sarcoidosis4220
□ Transposition of Great Vessels4221 □ Tetralogy of Fallot4222       
□ Ventricular Septal Defect4223
□ Other4224
OTHER RISK FACTORS
Height4225:

Weight4230:

cm

Cerebrovascular Disease
Diabetes Mellitus

4235

:

O No

4245

:

Currently on Dialysis

:

Patient Life Expectancy of >=1 Year

4270

:

Chronic Lung Disease

O Yes

O No
4255

O Yes

O No

O Yes

:

4250

Sleep Apnea

O Yes

O No

kg
4240

Hypertension
O Not documented

:

4260

:

O No

O Yes

O No

O Yes

O No

O Yes

O Not assessed

(By physician estimate)

D. DIAGNOSTIC STUDIES (COMPLETE ONLY ONCE FOR EPISODES OF CARE/ADMISSIONS WITH A GENERATOR IMPLANT OR CHANGE.)
LVEF Assessed5000:

O No

 If Yes, Most Recent LVEF

5005

:

_____________ %

 If Yes, Most Recent LVEF Timeframe5010:  
Electrophysiology Study

O <1 month  

5015

:

O No

 If Yes, EP Study Timeframe5020:
5025

 If Yes, VT Ablation Performed5030:

(check all that apply)

12 Lead ECG w/Automated Measurements5040:
PR Interval

5055

(Most recent EP Study)

 O  ≥ 1 to ≤ 3 months 

: O No

O Yes 

O No

O Yes

O > 3 to ≤ 6 months

O No

O >6 months

O Results Unattainable

□ Non­sustained VT5031  □ Sustained Monomorphic VT5032
□ Ventricular Flutter5034 □ Ventricular Fibrillation5035

 If Yes, EP Study Finding(s):

 If Yes, ECG Date

O  ≥ 1 to ≤ 3 months    O > 3 to ≤ 6 months    O >6 months

O Yes

O <1 month 

 If Yes, Ventricular Arrhythmias Induced

5045

O Yes

□ Sustained Polymorphic VT5033

O Yes

mm/dd/yyyy

: 

□  PR Interval Not Obtainable5056

: _____________ msec

QRS Duration (Non­Ventricular Paced Complex)5060:  _____________ msec 

(Exclude atrial fib , 2nd or 3rd° heart block, vent pacing)

□  Only Ventricular Paced QRS Complexes Present5061
(From surface ECG closest to first generator procedure)

Cardiac Rhythm(s):
(check all that apply)

□ AFib/Flutter
□ Paced5069

5065

□  Atrial Tachycardia
□ Sinus Rhythm5070

□ Idioventricular
□ Junctional5068
□ Second Degree Heart Block5071 □ Third Degree Heart Block5072

5066

5067

 If Paced, Underlying Atrial Rhythm5075:

O Sinus rhythm

O Atrial fib/flutter

O Sinus arrest    

 If Paced, Pacing Type5080:

O Atrial pacing  

O Ventricular pacing

O Both

O  Unknown

 If Ventricular pacing or Both, Ventricular Paced QRS Duration5085: _____________msec
Abnormal Intraventricular Conduction5090:

□ Left Anterior Fascicular Block
□ Delay, Nonspecific5098

5095  

© 2010 American College of Cardiology Foundation

O No     O  Yes

 If Yes, Intraventricular Conduction Type(s): (check all that apply)

□ Left Posterior Fascicular Block5096
□ Right Bundle Branch Block (RBBB)5099
2/23/2010

□ Left Bundle Branch Block (LBBB)5097
□ Ventricular Paced Rhythm5100
Page 2 of 5

NCDR® ICD Registry™ V2.1
Data Collection Form – Generator & Leads
Blood Pressure5105/5110:                     
____________ / ____________ mmHg

BUN5115:                    

mg/dL      

Hemoglobin5120:            

g/dL

Sodium5125:                

mEq/L      

Creatinine5130:

mg/dL

Potassium5135:   

mEq/L      

BNP5140:  

pg/mL       (OR)

□ Not Drawn5121
□  Not Drawn5131
NT­proBNP5145:

pg/mL      □ Not Drawn5146

□
□
□

Not Drawn5116
Not Drawn5126
Not Drawn5136

(Closest to procedure)

E. PROCEDURE INFORMATION (COMPLETE FOR EACH LAB VISIT)
Procedure Date/Time6000/6001:             
Procedure Type6005:     

O Initial generator implant

O Generator change

O Lead only

6010

Prophylactic Antibiotics w/in 1 Hr of Procedure Start Time
O No – not given, medical reason documented
Routine Warfarin (Coumadin) Therapy
:

O No     O  Yes

:

6030

 If Yes, INR

Premarket Clinical Trial

:

O Yes

: (w/in 1 month) O No     O  Yes

6025

 If Yes, INR Drawn

O No – not given, reason unspecified

6015

6020

 If Yes, Held for Procedure

:

O No     O  Yes
 If Yes, INR Drawn Date6035:

____________

6040

 : O No

mm/dd/yyyy

 If Yes, Clinical Trial Name6045:

O Yes   

F. ICD IMPLANT / EXPLANT (COMPLETE FOR EACH LAB VISIT IN WHICH AN INITIAL GENERATOR IMPLANT OR GENERATOR CHANGE WAS PERFORMED)
Operator’s Name6100,6105,6110:
ICD Indication6125:   
Planned Device Type

NPI6115:

O Primary prevention
6130

:

Device Implanted6135:

TIN6120:

O Secondary prevention

O Single chamber  

O Dual chamber

O CRT­D

O No     O  Yes

 If Yes, Final Device Type6140:

O Single chamber  
6145

 If CRT­D, CS/LV Lead Successful

O Yes

:

O Dual chamber

O Not implanted

O CRT­D

O Previously implanted

6150

 If Not Implanted, Reason CS/LV Lead Not Implanted :
O Vascular access  
O Coronary sinus access 
O CS dissection 

O Unacceptable threshold 

O Tributary vein access  
O Diaphragmatic stimulation

6160

 If Yes, ID6155: ________  OR

:  _______________________ Model Name6165:

Manufacturer

 If Yes, Serial Number

__________________________

Model Number6170: __________________________

6175

: __________________________

 If Yes, Lowest Energy Tested (LET) that was Successful6180: ____________ Joules        □ LET Not Tested6181
 If Yes, Upper Limit of Vulnerability (ULV)6185:

____________ Joules

□ ULV Not Tested6186

 If Procedure Type6005 = Generator Change
Reason(s) for Re­Implantation: (check all that apply)
□ End of expected battery life6190
□ Replaced at time of lead revision6191

□ Under manufacturer advisory/recalled6194 □ Faulty Connector/Header6195
 If Malfunction, Reason for Malfunction6200:
ATP or Shock Therapy Delivered

6205

 If Yes, ATP or Shock Therapy Appropriate
 If Yes, ATP Therapy Successful

 If Yes, Explant Date

:

O Defibrillation    

O Premature battery depletion

O No     O  Yes
(Code ‘Yes’ even if prior to this procedure)

mm/dd/yyyy

 If Yes, Device Returned To Manufacturer6235:

O No

6240

 If Yes, Battery Voltage

: ________  OR

O Yes

□ Voltage Not Available6241

:  ____________

6245

 If Yes, ID

6160

Manufacturer

:  _______________________ Model Name6165:

6250

 If Yes, Serial Number

O RV pacing   

O No     O  Yes

:

6220

O No     O  Yes

:

O  LV pacing  

O No     O  Yes

:

6215

 If Yes, Shock Therapy Successful

6230

O Atrial pacing
O No     O  Yes

:
6210

Device Explanted6225:                 

□ Upgrade6192
□ Infection6193
□ Device relocation6196    □ Malfunction6197 

: __________________________

© 2010 American College of Cardiology Foundation

2/23/2010

__________________________

6170

Model Number

: __________________________
Page 3 of 5

NCDR® ICD Registry™ V2.1
Data Collection Form – Generator & Leads
G. LEAD ASSESSMENT (COMPLETE FOR ALL LEADS, INCLUDING NEW LEADS IMPLANTED, EXISTING LEADS EXTRACTED, ABANDONED, OR REUSED)
Operator’s Name7000,7005,7010:

NPI7015: 

Lead Counter7025:

1

7030

TIN7020: 
2

3

O New Lead
O Existing Lead 

O New Lead
O Existing Lead 

O New Lead
O Existing Lead 

O RA endocardial
O LV epicardial 
O RV endocardial
O SVC/subclavian
O LV via CVS
O Subcutaneous array 
O Other

O RA endocardial
O LV epicardial 
O RV endocardial
O SVC/subclavian
O LV via CVS
O Subcutaneous array 
O Other

O RA endocardial
O LV epicardial 
O RV endocardial
O SVC/subclavian
O LV via CVS
O Subcutaneous array 
O Other

Existing Lead Function7070:

O Normal
O Abnormal
O Not assessed

O Normal
O Abnormal
O Not assessed

O  Normal
O  Abnormal
O  Not assessed

Manufacturer Advisory/Recall7075:

O No     O  Yes

O No     O  Yes

O  No     O  Yes

Existing Lead Status7080:

O Extracted
O Abandoned
O Reused

O Extracted
O Abandoned
O Reused

O  Extracted
O  Abandoned
O  Reused

O No     O  Yes

O No     O  Yes

O  No     O  Yes

O No     O  Yes

O No     O  Yes

O  No     O  Yes

O No     O  Yes

O No     O  Yes

O  No     O  Yes

O No     O  Yes

O No     O  Yes

O  No     O  Yes

O No     O  Yes

O No     O  Yes

O  No     O  Yes

O No     O  Yes

O No     O  Yes

O  No     O  Yes

Identification

:
Manufacturer7040:
Model Name7045:

ID7035:                  OR

Model Number7050:
Serial Number7055:
Lead Location7060:

COMPLETE FOR EXISTING LEADS ONLY
Existing Lead Implant Date7065: 

 If Extracted, Returned To Manufacturer7085:
7090

Existing Lead Placement Issues
7095

 If Yes, Dislodgement
 If Yes, Perforation

:

: 

7100

:

7105

 If Yes, Erosion

:
7110

 If Yes, Faulty Connector/Header

:

7115

 If Yes, Patient’s Clinical Status

: 

O No     O  Yes

O No     O  Yes

O  No     O  Yes

O No     O  Yes

O No     O  Yes

O  No     O  Yes

O No     O  Yes

O No     O  Yes

O  No     O  Yes

O No     O  Yes

O No     O  Yes

O  No     O   Yes

O No     O  Yes

O No     O  Yes

O  No     O   Yes

O No     O  Yes

O No     O  Yes

O  No     O   Yes

O No     O  Yes

O No     O  Yes

O  No     O   Yes

 If Yes, Failure to Capture with 
Acceptable Safety Margin7150:

O No     O  Yes

O No     O  Yes

O  No     O   Yes

 If Yes, Extracardiac Stimulation7155:

O No     O  Yes

O No     O  Yes

O  No     O   Yes

O No     O  Yes

O No     O  Yes

O  No     O   Yes

O No     O  Yes

O No     O  Yes

O  No      O   Yes

O No     O  Yes

O No     O  Yes

O  No      O   Yes

O No     O  Yes

O No     O  Yes

O  No      O   Yes

O No     O  Yes

O No     O  Yes

O  No      O   Yes

O No     O  Yes

O  No     O  Yes

O  No      O   Yes

O No     O  Yes

O  No     O  Yes

O  No      O   Yes

 If Yes, Infection

7120

: 

 If Yes, Documented Infection7125:

COMPLETE IF “EXISTING LEAD FUNCTION7070” IS “ABNORMAL”
Pacing Issues7130:
 If Yes, Oversensing

7135

:

7140

 If Yes, Undersensing

 If Yes, Failure to Pace

:

7145

:

Defibrillation Issues7160:
7165

 If Yes, Oversensing w/Shock or ATP

:

7170

 If Yes, Oversensing w/o Shock or ATP

 If Yes, Failure to Shock with Inadequate 
DFT Safety Margin7175:
Lead Integrity Issues7180:
 If Yes, Insulation Failure

7185

 If Yes, Conductor Failure

:

7190

:

© 2010 American College of Cardiology Foundation

:

2/23/2010

Page 4 of 5

NCDR® ICD Registry™ V2.1
Data Collection Form – Generator & Leads
H. INTRA OR POST PROCEDURE EVENTS (COMPLETE FOR EACH LAB VISIT)
Intra or Post Procedure Events Occurred8000:

O No

O Yes

 If Yes, specify the Event(s):
Cardiac Arrest 8005:
Drug Reaction

O No

8010

:

O No

Cardiac Perforation

8015

Cardiac Valve Injury
Conduction Block

:

O No

8020

:

O No

8025

:

O No

Coronary Venous Dissection

8030

:

O No

Hematoma (Req re­op, evacuation or transfusion)
Hemothorax

: O No

:
8050

Lead Dislodgement

O Yes

O Yes

Pericardial Tamponade

8060

O No

O Yes

O Yes

8065

:

O Yes

O No

O Yes

:

O No

O Yes

O No

O Yes

:                                    O No

O Yes

O Yes

:                       O No

O Yes

O No

O Yes

:

O No

8075

Set Screw Problem 

:

8070

Peripheral Nerve Injury

O Yes

8045

Peripheral Embolus

O Yes

O Yes

O No

Infection Requiring Antibiotics

Myocardial Infarction8055:                                        
O No

O Yes

8035

8040

O Yes

:

8080

Pneumothorax

:

TIA or Stroke (CVA)

8085

Urgent Cardiac Surgery 
Venous Obstruction 

8090

:

8095

:

O No

O Yes

O No

O Yes

I. DISCHARGE (COMPLETE FOR EACH EPISODE OF CARE/ADMISSION)
CABG9000: (During this admission)

O No

O Yes

 If Yes, CABG Date9005:

PCI9010: (During this admission)

O No

O Yes

 If Yes, PCI Date9015:

Discharge Date9020:     mm/dd/yyyy
Discharge Status9025: 

O Alive

 If Deceased, Cause of Death

9030

: 

 If Deceased, Death During the Procedure

O Deceased  

O Cardiac       O Non­Cardiac
9035

: 

 If Alive, Discharged Against Medical Advice

9040

:

O No

O Yes

O No

O Yes

 If No, specify the Discharge Medication(s) Prescribed:
Medication
No

Amiodarone9050

Dofetilide9060
Flecainide
9070

O  

O
O

O
O

9130

Digoxin (Any)

O

O

O

O  

O

O

O

O  

O

O

Statin9145

O

O  

O

O

Non­Statin9150

O

O  

O

O

Long Acting Nitroglycerin9155

O

O  

O

O

Clopidogrel9160

O

O  

O

O

Prasugrel9165

O

O  

O

O

Ticlopidine9170

O

O  

O

O

O

O  

O

O

Diuretic (Any)

O

O  

O

O

Hydralazine (Any)

O

O  

O

O

O

O  

O

O

9140

O  

O

O

O

O  

O

O

Propafenone9080

O

O  

O

O

Mexiletine9085

O

O  

O

O

Quinidine9090

O

O  

O

O

Sotalol9095

O

O  

O

O

Warfarin (Coumadin)9175

O

O  

O

O

O

O  

O

O

O

O  

O

O

O

O  

O

O

O

O  

O

O

O

O  

O

O

ASA (Any)

9100

9105

Beta Blocker (Any)
Diltiazem
Other

9110

9115

9120

Verapamil

9125

© 2010 American College of Cardiology Foundation

Blinded

O  

O

Procainmide

Prescribed
Yes
Con

O

9135

9075

Other

ARB (Any)

Calcium 
Channel 
Blockers

9065

O

O  

No

Platelet 
Aggregation 
Inhibitors

Antiarrhythmic Agents

Disopyramide

9055

O

Medication
Blinded

Lipid 
Lowering 
Agents

ACE Inhibitor (Any)

9045

Prescribed
Yes
Con

2/23/2010

Page 5 of 5


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