Form CMS-10443 TVT Registry

(CMS-10443) Transcatheter Valve Therapy Registry and KCCQ-10

2-1_tvt_tavrdcf 2020

TVT Registry

OMB: 0938-1202

Document [pdf]
Download: pdf | pdf
A. DEMOGRAPHICS
Last Name2000:
SSN2030:

Middle Name2020:

First Name2010:
-

Birth Date2050:

□ SSN N/A2031 Patient ID2040:

-

Sex2060: Male Female

mm / dd / yyyy
White2070

Race:
(check all that apply)

Other ID2045:

(auto)

Hispanic or Latino Ethnicity2076:
American2071

Black/African
Native Hawaiian/Pacific Islander2074

American Indian/Alaskan Native2073

No

Yes

Asian2072

B. EPISODE OF CARE
Arrival Date/Time3000,3001:

mm / dd / yyyy HH:MM

Private Health Insurance3005
Insurance Payors:
(check all that apply) State-Specific Plan (non-Medicaid)3009
HIC3015:

Research Study3030:

Medicare3006
Medicaid3007
Indian Health Service3010
No

Military Health Care3008
Non-US Insurance3011

None3012

If Yes, Study Patient ID3032:

Yes

C. HISTORY AND RISK FACTORS (PATIENT HISTORY AND RISK FACTORS UP TO THE PROCEDURE)
CARDIAC HISTORY
Infective Endocarditis4000:

No

If Yes, Infective Endocarditis
Type4005:

No

If Yes, Most Recent AV Procedure Date4065:
Treated Active

Permanent Pacemaker4010:

No

If Yes, Previous Pacer Date4012:

No

Prior PCI4020:

No

If Yes, Most Recent PCI Date4025:

No

If Yes, Most Recent CABG Date4035:
Surgery4040:

# Previous Cardiac Surgeries4055:

r _to D_e_v_i_c_e List
If Yes, AV Model ID4078: R_e_fe
__

Yes

Yes

If Yes, AV Repair – Surgical4080:

No

Yes

If Yes, AV Balloon Valvuloplasty4085:

No

Yes

If Yes, AV Transcatheter Valve Replacement4090:

No

Yes

If Yes, AV Transcath Valve Model ID4092: R_e_f_e_r_t_o_D
_e
_v
_i_c_e List
No
Yes
If Yes, AV Transcatheter Valve Intervention4091:

Yes

mm / dd / yyyy
No

mm / dd / yyyy

Not Documented

mm / dd / yyyy

Prior CABG4030:

Yes

If Yes, AV Replacement – Surgical4070:
No
Yes
If Yes, AV Type4075: Bioprosthetic stented Bioprosthetic stentless

Yes

mm / dd / yyyy

Previous ICD4015:

Prior Other Cardiac

Prior Aortic Valve Procedure4060:

Yes

Prior Non-Aortic Valve Procedure4095:

No

Yes

Surgical4100:

If Yes, MV Replacement –
No
Yes
4105 Mechanical Bioprosthetic stented
If Yes, MV Type :
Bioprosthetic stentless Not Documented
If Yes, MV Repair – Surgical4110:
No
Yes

Yes

0 1 2 3 >=4

OTHER HISTORY AND RISK FACTORS
Prior Stroke4120:

No

If Yes, Most Recent Stroke Date4125:
Transient Ischemic

Attack4130:

Carotid Stenosis4135: None

Hypertension4155:

mm / dd / yyyy
No

Right

Yes

Left

Diabetes Mellitus4165:
If Yes, Diabetes

Yes

Therapy4170:

If Right, Left or Both, Prior

No

Yes

No

Yes

Diet Oral
Other

Both N/A
Currently on Dialysis4175:

CEA/CAS4140:

None
Insulin

No

No

Yes

Yes

If R or B, Rt Carotid Severity4141(%): 50-79 80-99 100 N/A
If L or B, Lt Carotid Severity4142 (%): 50-79 80-99 100 N/A

Chronic Lung Disease4180: None Mild Moderate Severe
Home Oxygen4181:

No

Yes

Peripheral Arterial Disease4145:

No

Yes

Hostile Chest4182:

No

Yes

Current/Recent Smoker4150: (<1 Year)

No

Yes

Immunocompromise Present4185:

No

Yes

© 2017 STS and ACCF

5/20/2019 1:08 PM

Page 1 of 8

D. PRE-PROCEDURE STATUS (COMPLETE FOR THE PROCEDURE)
CAD Presentation5000: No Sxs, no angina (14 days)
Unstable angina (60 days)
Prior MI5005:

No

Sx unlikely to be ischemic (14 days)
Non-STEMI (7 days)

If Yes, Prior MI Timeframe5010:

Yes

Heart Failure w/in 2 Weeks5020:

No

NYHA Class w/in 2 Weeks5025:

I

II

III

Five Meter Walk Test

IV

No

Yes

No

Yes

Cardiac Procedure w/in 30 Days5040:

No

Yes

Porcelain Aorta5045:

No

Yes

No

Yes

Hours5035:

>= 30 days
No

Yes

5085

If Yes, Time 15090:

Cardiogenic Shock w/in 24 Hours5030:
Cardiac Arrest w/in 24

< 30 Days

Conduction Defect5055:

Yes

Stable angina (42 days)
STEMI (7 days)

: Not performed
Yes
seconds

If Yes, Time 25095:

seconds

35100:

seconds

If Yes, Time

STS Risk Score5105:
Atrial Fibrillation/Flutter5050:
If Yes, AF Class w/in past 30
KCCQ-12 Performed5169:
No

days5052:

If Yes, KCCQ-125170-5181:

Unable to walk

%:

None Persistent Paroxysmal

Yes
Q1a:

Q1b:

Q1c:

Q2:

Q3:

Q4:

Q5:

Q6:

Q7:

Q8a:

Q8b:

Q8c:

(See separate questionnaire)

CLINICAL DATA (CLOSEST TO THE PROCEDURE)
Height5200:

Weight5205:

cm

kg
□ Not Drawn5256

Hemoglobin5250:

g/dL

□ Not Drawn5251

Creatinine5255:

Platelet Count5260:

µL

□ Not Drawn5261

INR5265:

Albumin5270:

g/dL

□ Not Drawn5271

Bilirubin5275:

mg/dL

□ Not Drawn5276

FEV1 Predicted5280:

%

□ Not Performed5281

DLCO (Adjusted)5285:

%

□ Not Performed5286

mg/dL

□ Not Drawn5266

MEDICATIONS (ADMINISTERED WITHIN 24 HOURS PRIOR TO THE PROCEDURE)
Inotropes5400,5405
No Yes Contraindicated Blinded
(positive):

Anticoagulants5400,5405(any): No Yes Contraindicated Blinded
DIAGNOSTIC CATH FINDINGS / ECHOCARDIOGRAM FINDINGS
Diagnostic Cath5500:

No

 If Yes, Diagnostic Cath Date5505:

Yes

Number of Diseased Vessels5506:

None

Left Main Stenosis >=50%5507:

No

Proximal LAD >=70%5508:

No

Left Vent Internal Systolic Dim5595:

cm □ Not Measured5608

Yes

Left Vent Internal Diastolic Dim5600:

cm □ Not Measured5609

Yes

Septal Wall Thickness5605:

1

2

3

%

□ LVEF Not Assessed5566

Left Atrial Volume5606:

AV Disease Etiology5620: Degenerative
Endocarditis
LV outflow tract obstruction
Aortic Insufficiency5630: (highest)
Valve

Morphology5640:

Annular Calcification5645:
AV Peak Velocity

None

No

(CW)5650:

Primary aortic disease
Tumor
Trauma

mL/m2

Other

1+/Mild 2+/Moderate 3-4+/Severe
Tricuspid

Quadracuspid

Uncertain

Yes
m/s

AV Annulus Size5655:
Annulus Size Assessment
© 2017 STS and ACCF

Bicuspid

cm

ml or LA Volume Index5607:

Congenital
Rheumatic
Supravalvular aortic stenosis

Trace/Trivial

Unicuspid

cm

mmHg Posterior Wall Thickness5610:

Right Ventricular Systolic Pressure5568: (highest)
LVEF5565:

mm / dd / yyyy

mm
Method5660:

TTE

TEE
CTA
Angiography
5/20/2019 1:08 PM

Page 2 of 8

DIAGNOSTIC CATH FINDINGS / ECHOCARDIOGRAM FINDINGS (CONT.)
Aortic Stenosis5665:
If Yes, AV

No

Area5670:

Yes
cm2

(smallest)

If Yes, AV Mean Gradient5675: (highest)

mmHg

If Yes, AV Peak Gradient5680: (highest)

mmHg

Mitral Valve

Disease5685:

No

Yes

If Yes, Mitral Insufficiency5695: (highest)
If Yes, Mitral Stenosis5705:

No

None

Trace/Trivial

Yes

If Yes, MV Area5710: (smallest)

cm2

If Yes, MV Mean Gradient5715: (highest)

mmHg

Tricuspid Insufficiency5735: (highest)

1+/mild 2+/moderate 3+/mod/severe 4+/severe

None

Trace/Trivial

Mild

Moderate

Severe

E. PROCEDURE INFORMATION
□ Transcatheter Aortic Valve Replacement
□ Transcatheter Mitral Valve Replacement
Procedures:
Other Procedure Performed Concurrently6620: No
Yes-PCI
Yes-Other
6600

6601

□ Mitral Leaflet Clip Procedure6602

Operator A Name6000,6005,6010:

Operator A NPI6015:

Operator B Name6020,6025,6030:

Operator B NPI6035:

Procedure Start Date/Time6040,6041:
Procedure

Location6050:

Procedure Status6055:
Indication6060:

Primary Procedure

Valve-in-Valve Procedure6065:
Operator Reason for Procedure

mm / dd / yyyy HH:MM

:

Hybrid Cath Suite

CathLab

Other

Elective

Urgent

Emergency

Salvage

Primary AS

Primary AI

Mixed AS/AI

Failed Bioprosthetic Valve

If Yes, Status6070:

Yes

6080

If Yes, Reason

:

No
Yes
Access related
New clinical findings
System issue

Balloon valvuloplasty
Converted to medical therapy
Conversion to Open Heart Surgery6085:
No
Yes
Valve dislodged to aorta
Annulus rupture

CardioPulmonary Bypass Used6100:

Yes

No

No

Yes – IABP

If Yes, CPB Time6105:

Emergent

Type of Anesthesia6110: Moderate sedation

Yes

Valve dislodged to left ventricle
Aortic dissection

Mechanical Assist Device in Place at Start of

Elective

No

Device/delivery system malfunction
Consent Issue

Rescheduled transcatheter procedure
Converted to clinical trial

Procedure6095:

If Yes, Status6101:

Immediate intraprocedure

Navigation Issue after successful access
Patient status
Other (not specified)

If Yes, Action6082:

If Yes, Reason6090:

Elective

Inoperable/Extreme Risk (technically inoperable, co-morbid or deconditioned patient)
High risk (>=8% risk of 30 day mortality)
Intermediate risk (4-7% risk of 30 day mortality)
Low risk (<4% risk of 30 day mortality)

Evaluation of Suitability for Open AVR by Two Surgeons6072:

Procedure Aborted6075:

mm / dd / yyyy HH:MM

Hybrid OR Suite

No
6071

Procedure Stop Date/Time6045,6046:

General anesthesia

Conversion to open heart surgery
Other

Ventricular rupture
Coronary occlusion

Other

Yes - Catheter-based assist device
(Impella, Tandem Heart)
mins

Epidural

Combination

INTRA-PROCEDURE MEDICATIONS (ADMINISTERED DURING THE PROCEDURE)
Inotropes6120,6125: (positive)
© 2017 STS and ACCF

No

Yes

Contraindicated

Blinded

5/20/2019 1:08 PM

Page 3 of 8

DEVICE INFORMATION
Valve Sheath Access Site6200: Femoral
Transiliac
Valve Sheath Access Method6205:
Valve Sheath Delivery

Axillary

Transapical

Transaortic

Subclavian

Transseptal

Transcarotid

Transcaval

Other

Percutaneous

Size6210:

Cutdown

Mini thoracotomy

Other

Number6230:

French

6225

Device 1 Used

Mini sternotomy

: Refer to Master Device List (code all valves, embolic

Device 2 Used6225: protection, valve fracture and the BASILICA)

Device Serial
UDI6236, 6237, 62_38_:

(future)

_____
Device Implanted Successfully6232: No
Device Success6235: No
Yes

Yes

E. PROCEDURE INFORMATION – CONTINUED: POST IMPLANT
AV Gradient (mean)638_5:

mmHg

Calculated Aortic Valve Area6395:
Contrast Volume6450:

cm2

ml

Single Plane

Radiation Dose Measurement Method6455:
Fluoroscopy Time6460:
Cumulative Air Kerma6465:

Biplane

minutes
mGy

Dose Area Product6470:

DAP Units6475: Gy-cm2 cGy-cm2 mGy-cm2 µGy-M2

F. ADVERSE EVENTS, INTERVENTIONS AND SURGICAL PROCEDURES (SPECIFY THE EVENT DATE FOR EACH EVENT OCCURRENCE.)
Intra or Post Procedure Events Occurred7300:

No

Myocardial InfarctionE059:

mm / dd / yyyy

Bleeding at Access SiteE017:

mm / dd / yyyy

Coronary Compression or ObstructionE002:

mm / dd / yyyy

Hematoma at Access SiteE018:

mm / dd / yyyy

EndocarditisE003:

mm / dd / yyyy

Retroperitoneal BleedingE019:

mm / dd / yyyy

E0m
39: / dd / yyyy
Conduction/Native Pacer Disturbance Req Pacerm

GI BleedE020:

mm / dd / yyyy

40:m / dd / yyyy
Conduction/Native Pacer Disturbance Req ICDE0m

GU BleedE021:

mm / dd / yyyy

Cardiac ArrestE005:

mm / dd / yyyy

Other BleedE022:

mm / dd / yyyy

Atrial FibrillationE006:

mm / dd / yyyy

Device MigrationE023:

mm / dd / yyyy

Annular DissectionE007:

mm / dd / yyyy

Device Embolization Left VentricleE024:

mm / dd / yyyy

Aortic DissectionE008:

mm / dd / yyyy

Device Embolization AortaE025:

mm / dd / yyyy

Perforation with or w/o TamponadeE009:

mm / dd / yyyy

Device Recapture or RetrievalE026:

mm / dd / yyyy

Transient Ischemic AttackE010: (complete Adjudication) mm / dd / yyyy

Device ThrombosisE027:

mm / dd / yyyy

Ischemic StrokeE011:

mm / dd / yyyy

Other Device Related EventE028:

mm / dd / yyyy

mm / dd / yyyy

New Requirement for DialysisE029:

mm / dd / yyyy

mm / dd / yyyy

Aortic Valve Re-interventionE030: (complete Adjudication) mm / dd / yyyy

Transapical Related EventE014:

mm / dd / yyyy

Unplanned Other Cardiac Surgery or InterventionE031:
mm / dd / yyyy

Transaortic Related EventE015:

mm / dd / yyyy

Major Vascular ComplicationE041:

mm / dd / yyyy

(for Bleeding or Access Site Complication)

Minor Vascular ComplicationE042:

mm / dd / yyyy

PCIE033:

(complete Adjudication)

Hemorrhagic StrokeE012:

(complete Adjudication)

Undetermined StrokeE013:

(complete Adjudication)

If Yes, specify the Event7301 and Event Date(s)7302:

Yes

(not AVR or PCI)

Unplanned Vascular Surgery or InterventionE032:mm / dd / yyyy

© 2017 STS and ACCF

5/20/2019 1:08 PM

mm / dd / yyyy
Page 4 of 8

G. POST-PROCEDURE LABS AND TESTS
g/dL □ Not Drawn8041

Lowest Hemoglobin8040:

12-Lead ECG Findings8060:
Echocardiogram8065:

Not performed

Not Performed

If TTE, TEE, Date8070:

mg/dL

□ Not Drawn8051

Discharge Creatinine8055:

mg/dL

□ Not Drawn8056

No significant changes
Yes - TTE

New pathological Q-wave or LBBB

Yes - TEE

mm / dd / yyyy

If TTE, TEE, Mitral Regurgitation8075: None
If TTE, TEE, Aortic Stenosis8080:

Trace/Trivial

No

cm2

If TTE, TEE, AV Peak Doppler Velocity8086:

m/sec

Gradient8090:

1+/mild 2+/moderate 3+/mod/severe

4+/severe

Yes

If TTE, TEE, AV Area8085: (smallest)

If TTE, TEE, Mean

Highest Creatinine8050:

(highest)

mmHg

If TTE, TEE, Aortic Insufficiency Severity8095:

None

If Trace/Trivial, Mild, Moderate, or Severe Perivalvular

Trace/Trivial
Severity8106:

1+/Mild 2+/Moderate 3-4+/Severe

None Mild Moderate Severe Not documented

If Trace/Trivial, Mild, Moderate, or Severe Central Severity8107: None Mild Moderate Severe

Not documented

H. DISCHARGE (COMPLETE FOR EACH EPISODE OF CARE)
RBC/Whole Blood Transfusion9011:

No

Yes

Note: Code the total # of units between start of the procedure and discharge
If Yes, # Units Transfused9012:
Number of Hours in ICU9040:
Discharge Date9045:
Discharge

Status9050:

mm / dd / yyyy
Alive

Deceased

If Alive, Discharge Location9055: Home
Nursing home
If Deceased, Death in Lab/OR9060: No
If Deceased, Primary Cause of

Death9065:

Extended care/TCU/rehab
Hospice
Other

Other acute care hospital
Left against medical advice (AMA)

Yes
Cardiac
Valvular

Neurologic
Pulmonary

Renal
Unknown

Vascular
Other

Infection

DISCHARGE MEDICATIONS (DISCHARGE MEDICATIONS ARE NOT REQUIRED FOR PATIENTS WHO EXPIRED OR WERE DISCHARGED TO ‘OTHER ACUTE CARE HOSPITAL’,
‘HOSPICE’, OR ‘AMA’)

ACE Inhibitor9100,9105: (any)

No

Yes

Contraindicated

Blinded

Warfarin9100,9105:

No

Yes

Contraindicated

Blinded

ARB9100,9105:

No

Yes

Contraindicated

Blinded

Aspirin9100,9105: (any)

No

Yes

Contraindicated

Blinded

Dabigatran9100,9105:

No

Yes

Contraindicated

Blinded

Beta Blocker9100,9105: (any)

No

Yes

Contraindicated

Blinded

Antiarrhythmics9100,9105:

No

Yes

Contraindicated

Blinded

No

Yes

Contraindicated

Blinded

Factor Xa inhibitor9100,9105: (any) No

Yes

Contraindicated

Blinded

(any)

P2Y129100,9105: (any)

© 2017 STS and ACCF

(any)

5/20/2019 1:08 PM

Page 5 of 8

I. FOLLOW-UP (30 DAYS, 1 YEAR FROM DATE OF PROCEDURE)
Last Name2000:
Reference Procedure Start Date6040:

mm / dd / yyyy

First Name2010:

Patient ID2040:

Other ID2045:

Study Patient ID3032: (optional)

Assessment Date10000: mm / dd / yyyy (If the patient has not been discharged at 30 days, capture the 30 day F/U while still in the
facility.)
Primary Method to Determine Status10005:

Clinic

Medical record

Letter from medical provider

Phone call to patient/family
Status10010:

Alive

Deceased

Social Security death master file

Lost to follow-up

Withdrawn

Cardiac

Neurologic

Renal

Vascular

Valvular

Pulmonary

Unknown

Other

Other

Infection

If Deceased, Primary Cause of Death10015:

If Deceased, Date of Death10020: mm / dd / yyyy
Hemoglobin10085:

□ Not Drawn10086

g/dL

Creatinine10090:

□ Not Drawn10091

mg/dL

NYHA Classification at Follow-up10100: I II III IV
Five Meter Walk10135: Not performed Yes Unable to walk If Yes, Time 110140:
12-Lead ECG Findings10155:

Not performed

No significant changes

If New changes noted, ECG Changes Noted10160:

Echocardiogram10206:

Not Performed

Yes - TTE

Arrhythmia

If TTE, TEE, Date10207:

Yes - TEE

sec Time 310150:

sec

New changes noted

Pathological Q-wave or LBBB

% □ LVEF Not Assessed10211

If TTE, TEE, LVEF10210:

sec Time 210145:

Both

mm / dd / yyyy

If TTE, TEE, Mean Gradient10215: (highest)
mmHg

If TTE, TEE, Aortic Insufficiency Severity10220:

None

Trace/Trivial

1+/Mild 2+/Moderate 3-4+/Severe

If Trace/Trivial, Mild, Moderate, or Severe Perivalvular Severity10225:

None Mild

Moderate

Severe

Not documented

If Trace/Trivial, Mild, Moderate, or Severe Central Severity10227:

None Mild

Moderate

Severe

Not documented

KCCQ-12 Performed10230:

No

If Yes, KCCQ-1210231-10242:

Yes
Q1a:

Q1b:

Q1c:

Q5:

Q6:

Q7:

Q2:

Q3:

Q4:

(See separate
questionnaire)

© 2017 STS and ACCF

5/20/2019 1:08 PM

Q8a:

Q8b:

Q8c:

Page 6 of 8

I. FOLLOW-UP (CONT.) (30 DAYS, 1 YEAR FROM DATE OF PROCEDURE)
ADVERSE EVENTS, READMISSIONS, INTERVENTIONS

AND

SURGICAL PROCEDURES

(SPECIFY THE EVENT DATE FOR EACH EVENT THAT

OCCURRED BETWEEN

DISCHARGE AND 30-DAY F/U, OR BETWEEN F/U ASSESSMENT DATE #1 AND F/U ASSESSMENT DATE #2.)

Follow-Up Event(s) Occurred10245: No

If Yes, specify the Event10246 and Event Date(s)10247:

Yes

mm / dd / yyyy

Myocardial InfarctionE059:
EndocarditisE003:

mm / dd / yyyy

39
Conduction/Native Pacer Disturbance Req Pacem
:/ dd / yyyy
rE0m

40
Conduction/Native Pacer Disturbance Req ICDE0mm
: / dd / yyyy

Aortic Valve Re-interventionE030: (complete Adjudication) mm / dd / yyyy
E031
Unplanned Other Cardiac Surgery or Interventionm
m: / dd / yyyy

(not AVR or PCI)

Unplanned Vascular Surgery or InterventionE032: mm / dd / yyyy
(for Bleeding or Access Site Complication)

PCIE033:

mm / dd / yyyy

mm / dd / yyyy

Valve Related ReadmissionE034:

mm / dd / yyyy

mm / dd / yyyy

Non-Valve Related ReadmissionE035:

mm / dd / yyyy

mm / dd / yyyy

Major Vascular ComplicationE041:

mm / dd / yyyy

Undetermined StrokeE013: (complete Adjudication)

mm / dd / yyyy

Minor Vascular ComplicationE042:

mm / dd / yyyy

Device FractureE038:

mm / dd / yyyy

Transapical Related EventE014:

mm / dd / yyyy

Device ThrombosisE027:

mm / dd / yyyy

New Requirement for DialysisE029:

mm / dd / yyyy

Transient Ischemic AttackE010:
Ischemic StrokeE011:

(complete Adjudication)

(complete Adjudication)

Hemorrhagic StrokeE012:

(complete Adjudication)

FOLLOW-UP MEDICATIONS (MEDICATIONS PRESCRIBED OR TAKEN AT THE TIME O
ACE Inhibitor10250,10255: No Yes Contraindicated Blinded
Warfarin10250,10255:

No Yes Contraindicated Blinded

ARB10250,10255:

No Yes Contraindicated Blinded

Aspirin10250,10255:

No Yes Contraindicated Blinded

Major Bleeding EventE043 :
Life Threatening BleedingE037:

mm / dd / yyyy

mm / dd / yyyy

F FOLLOW-UP)

Beta
Blocker10250,10255:

No Yes Contraindicated Blinded

Antiarrhythmics10250,10255: No Yes Contraindicated Blinded
P2Y12

10250,10255

: (any)

No Yes Contraindicated Blinded

: o Yes Contraindicated Blinded
Factor Xa inhibitor10250,10255N

Dabigatran10250,10255: No Yes Contraindicated Blinded

Paperwork Reduction Act Disclosure Statement
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 0938-1202 (Expires XX/XX/XXXX). This is a mandatory
information collection. The time required to complete this information collection is estimated to average 56 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 C4-26-05, Baltimore, Maryland 21244-1850. ****CMS Disclosure****
Please do not send applications, claims, payments, medical records or any documents containing sensitive information to the PRA Reports
Clearance Office. Please note that any correspondence not pertaining to the information collection burden approved under the associated
OMB control number listed on this form will not be reviewed, forwarded, or retained. If you have questions or concerns regarding where to
submit your documents, please contact Sarah Fulton at [email protected].

© 2017 STS and ACCF

5/20/2019 1:08 PM

Page 7 of 8

J. ADJUDICATION FORM (COMPLETE FOR EACH ISCHEMIC, HEMORRHAGIC, UNDETERMINED STROKE, TIA OR AORTIC VALVE RE-INTERVENTION)
Last Name2000:

First Name2010:

Patient ID2040:

Reference Procedure Start Date6040: mm / dd / yyyy

Other ID2045:

Study Patient ID3032: (optional)

Adjudication Event12000:
Ischemic Stroke(In-hospital) Hemorrhagic Stroke(In-hospital) Undetermined Stroke(In-hospital) TIA(In-hospital) Aortic Valve Re-intervention(In-hospital) Ischemic
Stroke(F-U)

Hemorrhagic Stroke(F-U)

Event Date12005:
Status12010:
IF EVENT

TIA(F-U)

Aortic Valve Re-intervention(F-U)

mm / dd / yyyy

Alive

12000

Undetermined Stroke(F-U)

Deceased

If Deceased, Date of Death12011:

mm / dd / yyyy

= STROKE OR TIA

Date of Symptom Onset12015: (approximate)
Neurologic Deficit with Rapid

mm / dd / yyyy

Onset12020:

No

If Yes, Clinical Presentation12025:

Stroke/TIA

If Stroke/TIA, Symptom Duration > 24

hours12030:

If Stroke/TIA, Neuroimaging Performed12040:
If Yes, Deficit Type12045: No deficit Infarction Hemorrhage

Both (hem/infarc)

No

Yes

No

Yes

Subarachnoid Hemorrhage
No

Yes

If Stroke/TIA, Social/Recreational Activities Impaired12056:

No

Yes

If Stroke/TIA, Neurocognitive Functions Essential to Pt or their Livelihood Impaired12057: No

Yes

No

Yes

No

Yes

If Stroke/TIA, Death as a Result of Neurologic

IF EVENT

Non-Stroke

If Stroke/TIA, Neurologist/Neurosurgeon Confirmation of Diagnosis12055:

If Stroke/TIA, New Aids or Assistance Required12058:
Clinical

Yes

Comments12065:

12000

Deficit12060:

(information and details that may assist in assessing the stroke or TIA)

= AORTIC VALVE RE-INTERVENTION

Aortic Valve Re-intervention Date12100:

mm / dd / yyyy

Aortic Valve Re-intervention Type12105:

Surgical AV Repair/Replacement
Balloon Valvuloplasty

Transcatheter AVR
Other Transcatheter Intervention

If Other Transcatheter Intervention, Type12110:
Primary Indication12115:

Aortic insufficiency
Endocarditis

If Aortic Insufficiency, AI Severity12120: (highest)

Aortic stenosis
Valve thrombosis
None

Device migration
Other

Trace/Trivial

Device fracture

1+/Mild 2+/Moderate 3-4+/Severe

If Trace/Trivial, Mild, Moderate, or Severe Perivalvular Severity12125: None

Mild

Moderate

Severe

If Trace/Trivial, Mild, Moderate, or Severe Central Severity12130:

Mild

Moderate

Severe

If Aortic Stenosis, AS Severity12135: (highest) Possible stenosis

None

Significant stenosis

If Other, Other Indication12140:
Clinical Comments12145: (information and details that may assist in assessing this re-intervention)

© 2017 STS and ACCF

5/20/2019 1:08 PM

Page 8 of 8


File Typeapplication/pdf
File TitleVisio-TVT 2.2 TAVR DCF -May_20_2019.vsd
AuthorCMS
File Modified2020-09-03
File Created2020-09-02

© 2024 OMB.report | Privacy Policy