Form CMS-10443 TVT Data Collection Form

TVT RegistryTM v1.1 – Data Collection Form
For Transcatheter Valve Replacement Procedures
A. DEMOGRAPHICS
Last Name2000:

Middle Name2020:

First Name2010:

SSN2030:

-

Birth Date2050:

□ SSN N/A2031

-

Patient ID2040:
Sex2060:

mm / dd / yyyy

(check all that apply)

Hispanic or Latino Ethnicity2076:

O Male O Female

□ White2070
□ American Indian/Alaskan Native2073

Race:

Other ID2045:

(auto)

□ Black/African American2071
□ Native Hawaiian/Pacific Islander2074

O No

O Yes

□ Asian2072

B. EPISODE OF CARE
Arrival Date/Time3000,3001:
Insurance Payors:
(check all that apply)

mm / dd / yyyy HH:MM

□ Private Health Insurance3005
□ State-Specific Plan (non-Medicaid)3009

HIC3015:

Research Study3030:

□ Medicare3006
□ Medicaid3007
□ Indian Health Service3010
O No

O Yes

□ Military Health Care3008
□ Non-US Insurance3011 □ None3012

àIf Yes, Study Patient ID3032:

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

O No

àIf Yes, Infectious Endocarditis
Permanent Pacemaker
Previous ICD

4015

4005

:

O No

:

Prior PCI4020:

4030

Prior CABG

4025

:

O Yes

O No

O Yes

O No
4035

Prior Other Cardiac Surgery

:

# Previous Cardiac Surgeries

:

O No
:

àIf Yes, AV Replacement – Surgical
àIf Yes, AV Type

:

O No

O Yes

4075

: O Bioprosthetic stented O Bioprosthetic stentless

4085

àIf Yes, AV Balloon Valvuloplasty

:

àIf Yes, AV Transcatheter Valve Replacement

4090

:

4091

àIf Yes, AV Transcatheter Valve Intervention
Prior Non-Aortic Valve Procedure

:

4095

:
4100

àIf Yes, MV Replacement – Surgical

O 0 O 1 O 2 O 3 O >=4

O Yes

mm / dd / yyyy

àIf Yes, AV Repair – Surgical4080:

O Yes

O Yes

:

4070

mm / dd / yyyy

4040

4055

àIf Yes, Most Recent AV Procedure Date

O Yes

O No

O No
4065

mm / dd / yyyy

:

àIf Yes, Most Recent CABG Date

Prior Aortic Valve Procedure4060:

O Treated O Active

:

4010

àIf Yes, Most Recent PCI Date

O Yes

4105

àIf Yes, MV Type

:

:

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 Mechanical O Bioprosthetic

àIf Yes, MV Repair – Surgical

4110

:

O No

O Yes

O No

O Yes

O No

O Yes

O No

O Yes

O None

O Diet

O Oral

O Insulin

O Other

OTHER HISTORY AND RISK FACTORS
Prior Stroke4120:
àIf Yes, Most Recent Stroke Date4125:
4130

Transient Ischemic Attack

:

Hypertension4155:

mm / dd / yyyy

Dyslipidemia4160:

O No

Carotid Stenosis4135: O None

O Right

O Left
4140

àIf Right, Left or Both, Prior CEA/CAS

:

4141

àIf Right, Both, Right Carotid Severity
àIf Left, Both, Left Carotid Severity

:

4142

:

àIf Right, Left, Both, Sx w/in 60 days4144:
Peripheral Arterial Disease
Current/Recent Smoker

O Yes

O No

4145

:

O Both O NA

O No

: (<1 Year)

:

àIf Yes, Diabetes Therapy4170:

O Yes

4175
O 80-99% O 100% Currently on Dialysis :

O 80-99% O 100% Chronic Lung Disease
O No
O No

4150

Diabetes Mellitus

O Yes

4165

O No

O Yes
O Yes
O Yes

O No

: O None O Mild O Moderate O Severe

Home Oxygen4181:
4182

Hostile Chest

O Yes

4180

:
4185

Immunocompromise Present

:

O No

O Yes

O No

O Yes

O No

O Yes

D. PRE-PROCEDURE STATUS (COMPLETE FOR THE PROCEDURE)
CAD Presentation5000:

Prior MI5005:
© 2011 STS and ACCF

O No Sxs, no angina (14 days)

O Sx unlikely to be ischemic (14 days)

O Stable angina (42 days)

O Unstable angina (60 days)

O Non-STEMI (7 days)

O STEMI (7 days)

O No

O Yes

àIf Yes, Prior MI Timeframe5010:
4/27/2012 1:52 PM

O < 30 Days

O >= 30 days
Page 1 of 7

TVT RegistryTM v1.1 – Data Collection Form
For Transcatheter Valve Replacement Procedures
D. PRE-PROCEDURE STATUS CONT’D (COMPLETE FOR THE PROCEDURE)
Heart Failure w/in 2 Weeks5020:

O No

5025

NYHA Class w/in 2 Weeks

:

OI

O II

O III

O Yes

Conduction Defect5055:
5085

Five Meter Walk Test

O IV

5090

:

O No

O Yes

O No

O Yes

Cardiogenic Shock w/in 24 Hours5030:

O No

O Yes

àIf Yes, Time 1

:

_______ seconds

Cardiac Arrest w/in 24 Hours5035:

O No

O Yes

àIf Yes, Time 25095:

_______ seconds

5040

Cardiac Procedure w/in 30 Days

:

Porcelain Aorta5045:
Atrial Fibrillation/Flutter5050:
KCCQ-12 Performed
àIf Yes, KCCQ-12

5169

:

O No

5170-5181

5100

O No

O Yes

àIf Yes, Time 3

O No

O Yes

EuroSCORE II5110:

O No

O Yes

_______ seconds

:

_______ %

O Yes

Q1a: _______ Q1b: _______ Q1c: _______ Q2: _______ Q3: _______ Q4: _______

:

(See separate questionnaire)

_______ Q6:

Q5:

_______ Q7:

_______ Q8a: _______ Q8b: _______ Q8c: _______

CLINICAL DATA (CLOSEST TO THE PROCEDURE)
Height5200: ___________ cm

Weight5205: ___________ kg

Hemoglobin5250:

_______ g/dL

Platelet Count5260:

_______ µL

Albumin5270:

_______ g/dL

FEV1 Predicted5280:

_______ %

_______ mg/dL

□
□
□

Not Drawn5276

_______ %

□

Not Performed5286

□
□

Not Drawn5251

Creatinine5255:

_______ mg/dL

Not Drawn5261

INR5265:

_______

□
□

Not Drawn5271

Bilirubin5275:

5285
Not Performed5281 DLCO Predicted :

Not Drawn5256
Not Drawn5266

MEDICATIONS (ADMINISTERED WITHIN 24 HOURS PRIOR TO THE PROCEDURE)
Unfractionated Heparin5400,5405:
Anticoagulants

5400,5405

: (other)

Aspirin5400,5405:
Direct Thrombin Inhibitors

5400,5405

Inotropes5400,5405: (positive)

:

O No

O Yes

O Contraindicated

O Blinded

O No

O Yes

O Contraindicated

O Blinded

O No

O Yes

O Contraindicated

O Blinded

O No

O Yes

O Contraindicated

O Blinded

O No

O Yes

O Contraindicated

O Blinded

DIAGNOSTIC CATH FINDINGS / ECHOCARDIOGRAM FINDINGS
Diagnostic Cath5500:

O No
5506

Number of Diseased Vessels

:

5507

O1

O2

O3

O Yes

Left Atrial Area5592:

O No

O Yes

Left Ventricular Internal Systolic Dimension5595: ________ cm

□ LVEF Not Assessed5566

Left Ventricular Internal Diastolic Dimension5600: ________ cm

:

5508

:

LVEF5565: ________ %

O None

Right Ventricular Systolic Pressure5568: (highest) ________ mmHg
5590

Pulmonary Capillary Wedge Pressure

________ mmHg

:

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

O None

Valve Morphology5640:

O Unicuspid

5645

Annular Calcification

:

AV Peak Velocity (CW)5650:
AV Annulus Size

5655

:

O No

________ cm2

Septal Wall Thickness5605:
Posterior Wall Thickness

O Congenital
O Rheumatic
O Supravalvular aortic stenosis

O Trace/Trivial

O Mild

O Bicuspid

________ cm

5610

O Moderate

O Tricuspid

:

________ cm
O Primary aortic disease
O Tumor
O Trauma

O Other

O Severe

O Quadracuspid

O Uncertain

O Yes

________ m/s
________ mm

àAnnulus Size Assessment Method5660:
© 2011 STS and ACCF

mm / dd / yyyy

O No

Left Main Stenosis >=50%
Proximal LAD >=70%

à If Yes, Diagnostic Cath Date5505:

O Yes

O TTE

O TEE

O CTA

4/27/2012 1:52 PM

O Angiography
Page 2 of 7

TVT RegistryTM v1.1 – Data Collection Form
For Transcatheter Valve Replacement Procedures
DIAGNOSTIC CATH FINDINGS / ECHOCARDIOGRAM FINDINGS CONT’D
Aortic Stenosis5665:

O No

àIf Yes, AV Area5670: (smallest)

O Yes

________ cm2

àIf Yes, AV Mean Gradient5675: (highest)
àIf Yes, AV Peak Gradient
Mitral Valve Disease

________ mmHg

5680

: (highest)

5685

________ mmHg

O No

:

O Yes

àIf Yes, Mitral Insufficiency5695: (highest)
5705

àIf Yes, Mitral Stenosis

O No

:

O None

O Trace/Trivial

O Mild

O Moderate

O Severe

O Yes

àIf Yes, MV Area5710: (smallest)

________ cm2

àIf Yes, MV Mean Gradient5715: (highest) ________ mmHg
Tricuspid Valve Disease5720:

O No

àIf Yes, Tricuspid Insufficiency

O Yes

5735

: (highest)

O None

O Trace/Trivial

O Mild

O Moderate

O Severe

E. PROCEDURE INFORMATION
Operator A Name6000,6005,6010:

Operator A NPI6015:

Operator B Name6020,6025,6030:

Operator B NPI6035:

Procedure Start Date/Time6040,6041:
6050

Procedure Location

mm / dd / yyyy HH:MM

:

Procedure Status6055:
Primary Procedure Indication
Valve-in-Valve Procedure

6060

:

6065

:

Procedure Stop Date/Time6045,6046:

O Hybrid OR Suite

O Hybrid Cath Suite

O CathLab

O Other

O Elective

O Urgent

O Emergency

O Salvage

O Primary AS

O Primary AI

O Mixed AS/AI

O Failed Bioprosthetic Valve

O No

O Yes

àIf Yes, Status

6070

O Elective

:

Operator Reason for Procedure6071: O Patient preference
O Prohibitive risk (co-morbid conditions)
O Other
Evaluation of Suitability for Open AVR by Two Surgeons6072:
Procedure Aborted6075:
àIf Yes, Reason

O No

6080

Conversion to Open Heart Surgery6085:
àIf Yes, Reason

O No

6090

O No

O Inoperable (technical)
O Prohibitive risk (debilitated/deconditioned patient)

O Yes

O Annulus too large for implant
O Transapical access issue
O Inability to navigate from access to valve
O Other

O Yes

O Valve dislodged to aorta
O Annulus rupture

:

O Immediate intraprocedure

O Yes

O Difficult arterial access
O Transaortic access issue

:

mm / dd / yyyy HH:MM

O Valve dislodged to left ventricle
O Aortic dissection
6095

Mechanical Assist Device in Place at Start of Procedure

:

O No

O Yes – IABP

O Ventricular rupture
O Coronary occlusion

O Other

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

6100

CardioPulmonary Bypass Used
àIf Yes, Status6101:

:

O No

O Elective

O Yes

O Emergent

Type of Anesthesia6110: O Moderate sedation
Rapid Ventricular Pacing

6115

:

O No

àIf Yes, CPB Time6105: _______ mins

O General anesthesia

O Yes

O Epidural

O Combination

àIf Yes, Total Pacing Time6116: _______ mins

INTRA-PROCEDURE MEDICATIONS (ADMINISTERED DURING THE PROCEDURE)
Unfractionated Heparin6120,6125:

O No

O Yes

O Contraindicated

O Blinded

Anticoagulants6120,6125: (other)

O No

O Yes

O Contraindicated

O Blinded

O No

O Yes

O Contraindicated

O Blinded

O No

O Yes

O Contraindicated

O Blinded

Direct Thrombin Inhibitors
Inotropes6120,6125: (positive)
© 2011 STS and ACCF

6120,6125

:

4/27/2012 1:52 PM

Page 3 of 7

TVT RegistryTM v1.1 – Data Collection Form
For Transcatheter Valve Replacement Procedures
DEVICE INFORMATION
Minimum Lumen Diameter in Access Ilio-femoral Artery6195:
Valve Sheath Access Site6200:

O Femoral
O Transaortic

O Axillary
O Subclavian

Valve Sheath Access Method6205:

O Percutaneous

O Cutdown

Valve Sheath Delivery Size
Device 1 Used6225:
6225

Device 2 Used

6210

:

______________ French

Pulse

O Mini thoracotomy

Aortic Sys/Diastolic Pressure
Mean Aortic Pressure

6325,6380

6315,6320,6370,6375

:

:

Device Success

6235

: O No

_________ mm

______________
O Yes

________ bpm

________ bpm

________ / ________mmHg

________ / ________mmHg

________ mmHg

________ mmHg

:

Mean: ________ mmHg Peak: ________ mmHg

Calculated Aortic Valve Area

6340,6395

:

________ cm

Cardiac Output6345,6400:
Contrast Volume

: (pre-implant)

O Other

POST-IMPLANT

6385,6390

AV Gradient

6215

Device Serial Number6230:

PRE-IMPLANT

:

O Mini sternotomy

Largest Valvuloplasty Balloon Size

Refer to Device List
____________________________________________

:

Not Accessed6196

O Transapical
O Other

Refer to Device List
____________________________________________

HEMODYNAMICS
6310,6365

□

________ mm

2

________ cm2

________ L/min

________ L/min

6450

: _______ ml

Radiation Dose Measurement Method6455: O Single Plane
àFluoroscopy Time

O Biplane

_______ minutes

6460

:

àCumulative Air Kerma6465: _____ mGy
àDose Area Product6470:

àDAP Units6475: O Gy-cm2 O cGy-cm2

_______

O mGy-cm2

O µGy-M2

F. ADVERSE EVENTS, INTERVENTIONS AND SURGICAL PROCEDURES (SPECIFY THE EVENT DATE FOR EACH EVENT OCCURRENCE.)
Intra or Post Procedure Events Occurred7300: O No
Myocardial InfarctionE001:
Coronary Compression or Obstruction

:

EndocarditisE003:
Conduction/Native Pacer Disturbance
Cardiac Arrest

E004

:

:
:

Annular DissectionE007:
E008

Aortic Dissection

:

Perforation with or w/o TamponadeE009:
E010

Transient Ischemic Attack
Ischemic StrokeE011:
Hemorrhagic Stroke

:

(complete Adjudication)

(complete Adjudication)
E012

:

E013

(complete Adjudication)

Hematoma at Access SiteE018:

mm / dd / yyyy

Retroperitoneal Bleeding

mm / dd / yyyy

GI BleedE020:

mm / dd / yyyy

E021

mm / dd / yyyy

E006

Atrial Fibrillation

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

mm / dd / yyyy
E002

E005

O Yes

GU Bleed

mm / dd / yyyy

:

mm / dd / yyyy
mm / dd / yyyy

:

E022

Other Bleed

E019

mm / dd / yyyy
:

mm / dd / yyyy
E023

mm / dd / yyyy

Device Migration

:

mm / dd / yyyy

Device Embolization Left VentricleE024:

mm / dd / yyyy

E025

mm / dd / yyyy

Device Embolization Aorta

mm / dd / yyyy

Device Recapture or RetrievalE026:
E027

:

mm / dd / yyyy

mm / dd / yyyy

Device Thrombosis

mm / dd / yyyy

Other Device Related EventE028:

mm / dd / yyyy

mm / dd / yyyy

:

mm / dd / yyyy
mm / dd / yyyy

New Requirement for Dialysis

E029

E030

mm / dd / yyyy
:

mm / dd / yyyy

(complete Adjudication)

mm / dd / yyyy

Aortic Valve Re-intervention

E014

mm / dd / yyyy

Transortic Related EventE015:

Unplanned Other Cardiac Surgery or
InterventionE031: (not AVR or PCI)

mm / dd / yyyy

Unplanned Vascular Surgery or InterventionE032: mm / dd / yyyy

Vascular Access Site Complication Req
RxE016:

mm / dd / yyyy

Bleeding at Access SiteE017:

mm / dd / yyyy

Undetermined Stroke

:

Transapical Related Event

© 2011 STS and ACCF

:

: (complete Adjudication) mm / dd / yyyy
mm / dd / yyyy

(for Bleeding or Access Site Complication)

PCIE033:
4/27/2012 1:52 PM

mm / dd / yyyy
Page 4 of 7

TVT RegistryTM v1.1 – Data Collection Form
For Transcatheter Valve Replacement Procedures
G. POST-PROCEDURE LABS AND TESTS
Troponin8000:

O Yes – I

O No

àIf Yes, Date/Time

8005,8006

(ng/mL)

àIf not normal, CK-MB Value8030: _______ ng/mL
à ULN8035: ________

□
□

Lowest Hemoglobin8040:

_______ g/dL

Discharge Hemoglobin8045:

_______ g/dL

12-Lead ECG Findings8060:

O Not performed

Echocardiogram

:

O Not Performed
8070

àIf TTE, TEE, Date

O Drawn and normal O Drawn and not normal

àIf not normal, CK-MB Date/Time8025,8026: mm / dd / yyyy HH:MM

àURL8015: ________

8065

O Not Drawn

mm / dd / yyyy HH:MM

:

àIf Yes, Value8010: _______

CK8020:

O Yes – T

:

Not Drawn8041

Highest Creatinine8050:

______ mg/dL

Not Drawn8046

Discharge Creatinine8055:

______ mg/dL

O No significant changes

O Yes - TTE

□
□

Not Drawn8051
Not Drawn8056

O New pathological Q-wave or LBBB

O Yes - TEE

mm / dd / yyyy

àIf TTE, TEE, Mitral Insufficiency8075:
àIf TTE, TEE, Aortic Stenosis

O None

8080

O No

:

O Trace/Trivial

O Mild

O Moderate

O Severe

O Yes

àIf TTE, TEE, AV Area8085: (smallest)

________ cm2

àIf TTE, TEE, Mean Gradient8090: (highest)

________ mmHg

àIf TTE, TEE, Aortic Insufficiency Severity8095:

O None

O Trace/Trivial

àIf Trace/Trivial, Mild, Moderate, or Severe Perivalvular Severity

8106

:

8107

àIf Trace/Trivial, Mild, Moderate, or Severe Central Severity

:

O Mild

O Moderate

O Severe

O None

O Mild

O Moderate

O Severe

O None

O Mild

O Moderate

O Severe

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

O No

9012

àIf Yes, # Units Transfused
9040

Number of Hours in ICU
Discharge Date9045:
Discharge Status

O Yes

________

:

________

:

mm / dd / yyyy

9050

: O Alive

O Deceased

àIf Alive, Discharge Location

9055

: O Home
O Nursing home

O Extended care/TCU/rehab
O Hospice
O Other

àIf Deceased, Death in Lab/OR9060: O No

O Yes

àIf Deceased, Primary Cause of Death9065:

O Cardiac
O Valvular

O Neurologic
O Pulmonary

O Renal
O Unknown

O Other acute care hospital
O Left against medical advice (AMA)

O Vascular
O Other

O 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)
9100,9105

Warfarin
ARB

9100,9105

:

: (any)

9100,9105

Aspirin

Beta Blocker

: (any)

9100,9105

Antiarrhythmics

: (any)

9100,9105

9100,9105

Dabigatran
P2Y12

9100,9105

:

: (any)

© 2011 STS and ACCF

: (any)

O No

O Yes

O Contraindicated

O Blinded

O No

O Yes

O Contraindicated

O Blinded

O No

O Yes

O Contraindicated

O Blinded

O No

O Yes

O Contraindicated

O Blinded

O No

O Yes

O Contraindicated

O Blinded

O No

O Yes

O Contraindicated

O Blinded

O No

O Yes

O Contraindicated

O Blinded

O No

O Yes

O Contraindicated

O Blinded

4/27/2012 1:52 PM

Page 5 of 7

TVT RegistryTM v1.1 – Data Collection Form
For Transcatheter Valve Replacement Procedures
I. FOLLOW-UP (30 DAYS, 1 YEAR FROM DATE OF PROCEDURE)
Last Name2000:
Reference Procedure Start Date6040:
Assessment Date

mm / dd / yyyy

10000

Status

:

O Alive

Patient ID2040:

Other ID2045:

Study Patient ID3032:

(optional)

(Note: if the patient has not been discharged at 30 days, capture the 30 day F/U at the date of discharge.)

: mm / dd / yyyy

Primary Method to Determine Status10005:
10010

First Name2010:

O Clinic
O Medical record
O Phone call to patient/family

O Deceased

O Lost to follow-up
10015

àIf Deceased, Primary Cause of Death

O Letter from medical provider
O Social Security death master file

O Other

O Withdrawn

: O Cardiac
O Valvular

O Neurologic
O Pulmonary

O Renal
O Unknown

O Vascular
O Other

O Infection

àIf Deceased, Date of Death10020: mm / dd / yyyy

□ Not Drawn10086

Hemoglobin10085: _____ g/dL

Anginal Class at Follow-up10095: O No angina O I
Five Meter Walk

10135

: O No

O Not performed

àIf New changes noted, ECG Changes Noted
Echocardiogram10206: O Not Performed
àIf TTE, TEE, LVEF

O III

O IV

O Yes - TTE

: ________ %

O None

àIf Trace/Trivial, Mild, Moderate, or Severe Perivalvular Severity

O Trace/Trivial
10225

àIf Yes, KCCQ-12

:

O No
:

(See separate questionnaire)

Time 310150: _____ seconds

O Arrhythmia

O Both
mm / dd / yyyy

O Mild

O Moderate

O Severe

: O None

O Mild

O Moderate

O Severe

O None

O Mild

O Moderate

O Severe

àIf Trace/Trivial, Mild, Moderate, or Severe Central Severity10227:

10231-10243

O IV

________ mmHg

àIf TTE, TEE, Aortic Insufficiency Severity10220:

KCCQ-12 Performed

O III

O New changes noted

àIf TTE, TEE, Date10207:

O Yes - TEE

O II

□ LVEF Not Assessed10211

àIf TTE, TEE, Mean Gradient10215: (highest)

10230

□ Not Drawn10091

Time 210145: _____ seconds

O Pathological Q-wave or LBBB

:

_______ mg/dL

NYHA Classification at Follow-up10100: O I

O No significant changes

10160

10210

O II

àIf Yes, Time 110140: _____ seconds

O Yes

12-Lead ECG Findings10155:

Creatinine10090:

O Yes

Q1a: _______ Q1b: _______ Q1c: _______ Q2: _______ Q3: _______ Q4: _______
Q5:

_______ Q6:

_______ Q7:

_______ Q8a: _______ Q8b: _______ Q8c: _______

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: O No

O Yes

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

Myocardial InfarctionE001:

mm / dd / yyyy

Transient Ischemic AttackE010: (complete Adjudication)

mm / dd / yyyy

Ischemic StrokeE011:

mm / dd / yyyy

Hemorrhagic Stroke

(complete Adjudication)
E012

: (complete Adjudication)

Undetermined StrokeE013:

(complete Adjudication)
E014

Transapical Related Event

:

New Requirement for DialysisE029:
Aortic Valve Re-intervention

E030

: (complete Adjudication)

Unplanned Other Cardiac Surgery or InterventionE031: mm / dd / yyyy
(not AVR or PCI)
Unplanned Vascular Surgery or InterventionE032:
(for Bleeding or Access Site Complication)

PCIE033:

mm / dd / yyyy
E034

mm / dd / yyyy

mm / dd / yyyy

Valve Related Readmission

mm / dd / yyyy

Non-Valve Related ReadmissionE035:

:

E036

mm / dd / yyyy

Major Vascular Complication

mm / dd / yyyy

Life Threatening BleedingE037:

mm / dd / yyyy

Device Fracture

mm / dd / yyyy

mm / dd / yyyy
mm / dd / yyyy

:

mm / dd / yyyy

E038

mm / dd / yyyy

:

FOLLOW-UP MEDICATIONS (MEDICATIONS PRESCRIBED OR TAKEN AT THE TIME OF FOLLOW-UP)
ACE Inhibitor10250,10255:

O No

O Yes

O Contraindicated O Blinded

Aspirin10250,10255:

Warfarin10250,10255:

O No

O Yes

O Contraindicated O Blinded

Beta Blocker10250,10255:

ARB

10250,10255

:

Dabigatran10250,10255:
© 2011 STS and ACCF

O Yes

O Contraindicated O Blinded

O No

O Yes

O Contraindicated O Blinded

: O No O Yes

O Contraindicated O Blinded

10250,10255

O No

O Yes

O Contraindicated O Blinded

Antiarrhythmics

O No

O Yes

O Contraindicated O Blinded

P2Y1210250,10255: (any)

4/27/2012 1:52 PM

O No

O No

O Yes

O Contraindicated O Blinded
Page 6 of 7

TVT RegistryTM v1.1 – Adjudication Form
For Transcatheter Valve Replacement Procedures
J. ADJUDICATION FORM
Last Name

2000

(COMPLETE FOR EACH ISCHEMIC, HEMORRHAGIC, UNDETERMINED STROKE, TIA OR AORTIC VALVE RE-INTERVENTION)

:

Reference Procedure Start Date6040: mm / dd / yyyy
Adjudication Event

12000

:

O Stroke

Adjudication Date12005:
Status12010:

O Alive

12000

àIf Event

O TIA

First Name2010:

Patient ID2040:

Other ID2045:

Study Patient ID3032:

(optional)

O Aortic Valve Re-intervention

mm / dd / yyyy
àIf Deceased, Date of Death12011:

O Deceased

mm / dd / yyyy

= Stroke or TIA

Date of Symptom Onset12015: (approximate)

mm / dd / yyyy

Neurologic Deficit with Rapid Onset12020:

O No

12025

àIf Yes, Clinical Presentation

:

O Stroke/TIA

àIf Stroke/TIA, Symptom Duration > 24 hours12030:
12035

àIf Stroke/TIA, Therapeutic Intervention Performed

:

àIf Stroke/TIA, Neuroimaging Performed12040:
12045

àIf Yes, Deficit Type

:

O No deficit

O Infarction

O Hemorrhage

àIf Stroke/TIA, Lumbar Puncture Confirmation of Intracranial Hemorrhage
àIf Stroke/TIA, Neurologist/Neurosurgeon Confirmation of Diagnosis
12060

àIf Stroke/TIA, Death as a Result of Neurologic Deficit
Clinical Comments

O Yes

12050

:

12055

:

:

O Non-Stroke

O No

O Yes

O No

O Yes

O No

O Yes

O Both
O No

O Yes

O No

O Yes

O No

O Yes

12065

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

àIf Event12000 = Aortic Valve Re-intervention
Aortic Valve Re-intervention Date12100:
Aortic Valve Re-intervention Type

12105

:

mm / dd / yyyy
O Surgical AV Repair/Replacement
O Balloon Valvuloplasty

àIf Other Transcatheter Intervention, Type12110:
Primary Indication12115:

O Transcatheter AVR
O Other Transcatheter Intervention

__________________________________________________________________

O Aortic insufficiency
O Endocarditis

àIf Aortic Insufficiency, AI Severity12120: (highest)

O Aortic stenosis
O Valve thrombosis
O None

O Device migration
O Other

O Trace/Trivial

àIf Trace/Trivial, Mild, Moderate, or Severe Perivalvular Severity12125: O None
12130

àIf Trace/Trivial, Mild, Moderate, or Severe Central Severity
àIf Aortic Stenosis, AS Severity
12140

àIf Other, Other Indication
Clinical Comments

© 2011 STS and ACCF

12135

:

: (highest)

:

O Possible stenosis

O None

O Mild

O Device fracture
O Moderate

O Severe

O Mild

O Moderate

O Severe

O Mild

O Moderate

O Severe

O Significant stenosis

_______________________________________________________________________________

12145

: (information and details that may assist in assessing this re-intervention)

4/27/2012 1:52 PM

Page 7 of 7