Form CMS-10443 TVT Registry

STS/ACC TVT RegistryTM v2.0
For Transcatheter Aortic Valve Replacement Procedures
A. DEMOGRAPHICS
First Name2010:

Last Name2000:
SSN2030:

2050

Birth Date

o SSN N/A2031

-

:

Patient ID2040:
Sex2060:

mm / dd / yyyy

Middle Name

2070

Hispanic or Latino Ethnicity
2071

o Black/African American
2074
o Native Hawaiian/Pacific Islander

o White
2073
o American Indian/Alaskan Native

Race:
(check all that apply)

:

Other ID2045:

(auto)

O Male O Female

2020

2076

:

O No

o Asian

O Yes

2072

B. EPISODE OF CARE
Arrival Date/Time

3000,3001

mm / dd / yyyy HH:MM

:

3005

3006

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

Research Study

3030

:

o Medicare
o Medicaid
o Indian Health Service3010
O No

3008

o Military Health Care
o Non-US Insurance3011

If Yes, Study Patient ID

O Yes

C. HISTORY AND RISK FACTORS (PATIENT HISTORY AND RISK FACTORS UP TO THE

3007

3032

o None3012

:

PROCEDURE)

CARDIAC HISTORY
Infective Endocarditis

4000

O No

:

If Yes, Infective Endocarditis
4005
Type :
4010
Permanent Pacemaker :

O Treated

Previous ICD

O Active

Prior Aortic Valve Procedure

4060

:

O No

If Yes, Most Recent AV Procedure Date

4065

:

mm / dd / yyyy

:

If Yes, AV Replacement – Surgical :
O No
O Yes
4075
:O Bioprosthetic stented O Bioprosthetic stentless
If Yes, AV Type

O Yes

O Not Documented

mm / dd / yyyy

4015

:

O No

Refer to Device List

4078

If Yes, AV Model ID

O Yes

:

4080

If Yes, AV Repair – Surgical
Prior PCI

4020

:

O No

If Yes, Most Recent PCI Date

4025

O No

If Yes, Most Recent CABG Date

4035

:

4040

:

# Previous Cardiac Surgeries

4055

O Yes

mm / dd / yyyy
O No

:

O Yes

mm / dd / yyyy

:

Prior CABG4030:

Prior Other Cardiac Surgery

O Yes

4070

O No

4012

If Yes, Previous Pacer Date

O Yes

:

If Yes, AV Balloon Valvuloplasty

4085

:

If Yes, AV Transcatheter Valve Replacement

4090

:

O No

O Yes

O No

O Yes

O No

O Yes

4092

If Yes, AV Transcath Valve Model ID
: Refer to Device List
4091
If Yes, AV Transcatheter Valve Intervention :
O No
O Yes
4095

Prior Non-Aortic Valve Procedure

:

If Yes, MV Replacement – Surgical

O Yes

4100

:

O No

O Yes

O No

O Yes

If Yes, MV Type4105:O Mechanical O Bioprosthetic stented
O Bioprosthetic stentless O Not Documented
4110
If Yes, MV Repair – Surgical
:
O No
O Yes

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

OTHER HISTORY AND RISK FACTORS
Prior Stroke4120:

O No

If Yes, Most Recent Stroke Date
Transient Ischemic Attack
Carotid Stenosis

4130

4125

:

:

O Yes

Hypertension4155:

mm / dd / yyyy

Diabetes Mellitus

O No

4135

: O None

O Right

O Left

4165

:

If Yes, Diabetes Therapy

O Yes

4170

O No

O Yes

O No

O Yes

O Diet O Oral
O Other

O Both O N/A
Currently on Dialysis4175:

If Right, Left or Both, Prior CEA/CAS4140:

: O None
O Insulin

O No

O Yes
Chronic Lung Disease

4180

O No

O Yes

: O None O Mild O Moderate O Severe

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

© 2011 STS and ACCF

4150

(%):O 50-79 O 80-99 O 100 O N/A

Home Oxygen

4181

:

4145

O No

O Yes

Hostile Chest

: (<1 Year)

O No

O Yes

Immunocompromise Present

Peripheral Arterial Disease
Current/Recent Smoker

4142

:

4182

:
4185

3/4/2015 4:28 PM

:

O No

O Yes

O No

O Yes

O No

O Yes

Page 1 of 8

STS/ACC TVT RegistryTM v2.0
For Transcatheter Aortic Valve Replacement Procedures
D. PRE-PROCEDURE STATUS (COMPLETE FOR THE

O No Sxs, no angina (14 days)
O Unstable angina (60 days)

CAD Presentation5000:
Prior MI

PROCEDURE)

5005

O No

:

O Yes

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

If Yes, Prior MI Timeframe

Heart Failure w/in 2 Weeks5020:

O No

5010

:

O < 30 Days
5055

O Yes

Conduction Defect

O III

O IV

Five Meter Walk Test
5090
If Yes, Time 1 :

O No

O Yes

O No

O Yes

O No

O Yes

O No

O Yes

O No

O Yes

:

5085

NYHA Class w/in 2 Weeks

5025

:

OI

Cardiogenic Shock w/in 24 Hours
Cardiac Arrest w/in 24 Hours

O II

5030

:

5035

:

Cardiac Procedure w/in 30 Days

5040

:

5045

Porcelain Aorta
Atrial

:

Fibrillation/Flutter

5050

:
5052

5170-5181

:

(See separate questionnaire)

O >= 30 days

O No
O Yes
: O Not performed O Yes
seconds

If Yes, Time 2

5095

:

seconds

If Yes, Time 3

5100

:

seconds

STS Risk Score

5105

:

O Unable to walk

%:

O None O Persistent O Paroxysmal

If Yes, AF Class w/in past 30 days :
5169
K CC Q-12 Performed :
O No
O Yes
If Yes, KCCQ-12

O Stable angina (42 days)
O STEMI (7 days)

Q1a:

Q1b:

Q1c:

Q2:

Q3:

Q4:

Q5:

Q6:

Q7:

Q8a:

Q8b:

Q8c:

CLINICAL DATA (CLOSEST TO THE PROCEDURE)
Height

5200

:

Weight

cm
5250

Hemoglobin

Platelet Count

:

5260

:

5270

Albumin

:

FEV1 Predicted

5280

:

5251

o Not Drawn

µL

o Not Drawn5261

g/dL

o Not Drawn

%

o Not Performed
TO THE

:

kg

5255

g/dL

MEDICATIONS (ADMINISTERED WITHIN 24 HOURS PRIOR

5205

Creatinine
5265

INR

5271

o Not Drawn

5256

o Not Drawn5266

:

Bilirubin
5281

mg/dL

:

5275

:

DLCO (Adjusted)

5285

:

mg/dL

o Not Drawn5276

%

o Not Performed

5286

PROCEDURE)
5400,5405

Anticoagulants5400,5405(any):

O No O Yes O Contraindicated O Blinded

Inotropes
(positive):

O No O Yes O Contraindicated O Blinded

DIAGNOSTIC CATH FINDINGS / ECHOCARDIOGRAM FINDINGS
5500

Diagnostic Cath

:

O No

Number of Diseased Vessels
Left Main Stenosis >=50%
Proximal LAD >=70%

5508

5506

5505

If Yes, Diagnostic Cath Date

O Yes
:

O None

5507

:

:

O1

O2

LVEF

5565

O No

O Yes

Septal Wall Thickness

AV Disease Etiology5620: O Degenerative
O Endocarditis
O LV outflow tract obstruction
O None

Valve Morphology5640:

O Unicuspid

Annular Calcification

AV Peak Velocity (CW)

:

5650

O No
:

© 20 11 STS and ACCF

cm
:

cm

ml or LA Volume Index

O Congenital
O Rheumatic
O Supravalvular aortic stenosis

O Trace/Trivial

5609

5607

:

O Primary aortic disease
O Tumor
O Trauma

mL/m2

O Other

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

O Bicuspid

O Tricuspid

O Quadracuspid

O Uncertain

m/s

:

Annulus Size Assessment Method

:

cm o Not Measured

O Yes

5655

AV Annulus Size

:

5610

5606

Left Atrial Volume

:

5605

mmHg Posterior Wall Thickness

: (highest)

Aortic Insufficiency5630: (highest)

cm o Not Measured5608

5600

Left Vent Internal Diastolic Dim

o LVEF Not Assessed

5645

Left Vent Internal Systolic Dim5595:

O Yes

5566

%

:

mm / dd / yyyy

O No

5568

Right Ventricular Systolic Pressure

O3

:

mm
5660

:

O TTE

O TEE

O CTA

3/4/2015 4:28 PM

O Angiography
Page 2 of 8

STS/ACC TVT RegistryTM v2.0
For Transcatheter Aortic Valve Replacement Procedures
DIAGNOSTIC CATH FINDINGS / ECHOCARDIOGRAM FINDINGS CONT’D
Aortic Stenosis

5665

:

If Yes, AV Area

O No

5670

2

: (smallest)
5675

If Yes, AV Mean Gradient
If Yes, AV Peak Gradient
5685

Mitral Valve Disease

5680

: (highest)

mmHg

: (highest)

mmHg

O No

If Yes, Mitral Stenosis
5710

cm

:

If Yes, Mitral Insufficiency

If Yes, MV Area

O Yes

5705

5695

O Yes
O None O Trace/Trivial

: (highest)
O No

:

5735

Tricuspid Insufficiency

5715

O 4+/severe

O Yes
2

: (smallest)

If Yes, MV Mean Gradient

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

cm

: (highest)

: (highest)

mmHg

O None

O Trace/Trivial

O Mild

O Moderate

O Severe

E. PROCEDURE INFORMATION
6600

o Transcatheter Aortic Valve Replacement
o Transcatheter Mitral Valve Replacement
Procedures:
6620
Other Procedure Performed Concurrently
: O No O Yes-PCI
O Yes-Other

o Mitral Leaflet Clip Procedure6602

:

Operator A NPI

6015

Operator B Name6020,6025,6030:

Operator B NPI

6035

Operator A Name

6000,6005,6010

6601

Procedure Start Date/Time
Procedure

6040,6041

mm / dd / yyyy HH:MM

:

6050

Location

Procedure Status

:

6055

:

Primary Procedure Indication6060:
Valve-in-Valve Procedure

6065

:

Procedure Stop Date/Time

6045,6046

:
:

:

mm / dd / yyyy HH:MM

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

6070

O Yes

:

If Yes, Status

O Elective

O Immediate intraprocedure

Operator Reason for Procedure6071: O Inoperable/Extreme Risk (technically inoperable, co-morbid or deconditioned

patient)

O High risk (>=8% risk of 30 day mortality)
O Intermediate risk (4-7% risk of 30 day mortality)
O Low risk (<4% risk of 30 day mortality)
Evaluation of Suitability for Open AVR by Two Surgeons6072:
Procedure Aborted6075:
If Yes, Reason

6080

:

O No
O Yes
O Access related
O New clinical findings
O System issue

O Balloon valvuloplasty
O Converted to medical therapy
Conversion to Open Heart Surgery6085:
O No O Yes
6090

:

O Rescheduled transcatheter procedure
O Converted to clinical trial

O Valve dislodged to aorta
O Annulus rupture

O Valve dislodged to left ventricle
O Aortic dissection
6095

Mechanical Assist Device in Place at Start of Procedure
CardioPulmonary Bypass Used
6101

If Yes, Status

Type of Anesthesia

:

6110

6100

O Elective

:

O No

:

O No

O Yes – IABP

O Device/delivery system malfunction
O Consent Issue

O Conversion to open heart surgery
O Other

O Ventricular rupture
O Coronary occlusion

O Other

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

O Yes

O Emergent

: O Moderate sedation

O Yes

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

If Yes, Action6082:

If Yes, Reason

O No

If Yes, CPB Time

6105

O General anesthesia

:

mins

O Epidural

O Combination

INTRA-PROCEDURE MEDICATIONS (ADMINISTERED DURING THE PROCEDURE)
Inotropes

6120,6125

: (positive)

© 2011 STS and ACCF

O No

O Yes

O Contraindicated

O Blinded

3/4/2015 4:28 PM

Page 3 of 8

STS/ACC TVT RegistryTM v2.0
For Transcatheter Aortic Valve Replacement Procedures
DEVICE INFORMATION
6200

Valve Sheath Access Site

: O Femoral
O Subclavian

Valve Sheath Access Method
Valve Sheath Delivery Size

6205

:

O Axillary

O Transapical

O Transaortic

O Transiliac

O Transseptal

O Transcarotid

O Percutaneous

6210

:

O Cutdown

O Mini thoracotomy

Refer to Device List

Device 2 Used6225:

Refer to Device List

O Mini sternotomy

O Other

6230

French

Device 1 Used6225:

O Other

Device Serial Number :
(future)
UDI6236, 6237, 6238:
Device Implanted Successfully6232: O No
Device Success6235: O No
O Yes

O Yes

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

6385

:

mmHg

Calculated Aortic Valve Area

6395

2

:

Contrast Volume6450:

cm

ml

Radiation Dose Measurement Method6455:

O Single Plane

6460

Fluoroscopy Time

:

O Biplane

minutes
6465

Cumulative Air Kerma

:

mGy

Dose Area Product6470:

DAP 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.)
7300

Intra or Post Procedure Events Occurred

:

E059

Myocardial Infarction

:
E002

Coronary Compression or Obstruction

:

EndocarditisE003:

O No

If Yes, specify the Event

O Yes

Hematoma at Access SiteE018:

mm / dd / yyyy

Retroperitoneal Bleeding

E039

GI Bleed

Atrial Fibrillation

:

E006

:

E007

Annular Dissection

:

E008

Aortic Dissection

:

Perforation with or w/o Tamponade
Transient Ischemic Attack
E011

Ischemic Stroke

:

E010

:

E009

:

(complete Adjudication)

(complete Adjudication)

Hemorrhagic StrokeE012: (complete Adjudication)
Undetermined Stroke

E013

:

(complete Adjudication)
E014

mm / dd / yyyy
mm / dd / yyyy

GU Bleed

:

mm / dd / yyyy

:

E021

mm / dd / yyyy

:

E022

mm / dd / yyyy

Other Bleed

mm / dd / yyyy

Device Migration

mm / dd / yyyy

:
E023

mm / dd / yyyy

:

mm / dd / yyyy

Device Embolization Left Ventricle

mm / dd / yyyy

Device Embolization Aorta

:

mm / dd / yyyy

Device Recapture or Retrieval

E026

mm / dd / yyyy

Device Thrombosis

:

mm / dd / yyyy

Major Vascular Complication

E041

:

mm / dd / yyyy
mm / dd / yyyy

E028

New Requirement for Dialysis

Transaortic Related Event

mm / dd / yyyy
mm / dd / yyyy

:

mm / dd / yyyy

mm / dd / yyyy

:

E027

Other Device Related Event

mm / dd / yyyy

E024

E025

mm / dd / yyyy

:

Transapical Related Event

:

E019

E020

:
mm / dd / yyyy

mm / dd / yyyy

E040

7302

E017

Bleeding at Access Site

Conduction/Native Pacer Disturbance Req ICD m:m / dd / yyyy
Cardiac Arrest

and Event Date(s)

mm / dd / yyyy

Conduction/Native Pacer Disturbance Req Pacermm : / dd / yyyy

E005

7301

Aortic Valve Re-intervention

mm / dd / yyyy

:

E029

:

E030

:

mm / dd / yyyy

(complete Adjudication)

mm / dd / yyyy

E031

Unplanned Other Cardiac Surgery or Intervention
:
mm / dd / yyyy
(not AVR or PCI)

E015

Unplanned Vascular Surgery or Intervention

:

mm / dd / yyyy

(for Bleeding or Access Site Complication)

Minor Vascular ComplicationE042:

mm / dd / yyyy

PCIE033:

© 2011 STS and ACCF

3/4/2015 4:28 PM

E032

: mm / dd / yyyy

mm / dd / yyyy
Page 4 of 8

STS/ACC TVT RegistryTM v2.0
For Transcatheter Aortic Valve Replacement Procedures
G. POST-PROCEDURE LABS AND

TESTS

Lowest Hemoglobin8040:

g/dL o Not Drawn

8060

12-Lead ECG Findings
Echocardiogram

8065

O Not performed

:

O Not Performed

:

If TTE, TEE, Date

8070

Highest Creatinine8050:

mg/dL

o Not Drawn

8051

Discharge Creatinine8055:

mg/dL

o Not Drawn

8056

O No significant changes

O Yes - TTE

O New pathological Q-wave or LBBB

O Yes - TEE

mm / dd / yyyy

:

If TTE, TEE, Mitral Regurgitation8075: O None
If TTE, TEE, Aortic Stenosis
If TTE, TEE, AV Area

8041

8085

8080

O Trace/Trivial

O No

:

O 4+/severe

O Yes
2

cm

: (smallest)

If TTE, TEE, AV Peak Doppler Velocity
If TTE, TEE, Mean Gradient

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

8086

m/sec

:

8090

mmHg

: (highest)

If TTE, TEE, Aortic Insufficiency Severity

8095

O None

:

O Trace/Trivial

If Trace/Trivial, Mild, Moderate, or Severe Perivalvular Severity
If Trace/Trivial, Mild, Moderate, or Severe Central Severity

8107

8106

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

: O None O Mild

O Moderate

O Severe O Not documented

O None O Mild

O Moderate

O Severe O Not documented

:

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

9011

:

O No

O Yes

Note: Code the total # of units between start of the procedure and discharge
9012

If Yes, # Units Transfused

:

9040

Number of Hours in ICU
9045

Discharge Date

Discharge Status

:

:

mm / dd / yyyy

9050

: O Alive

O Deceased

If Alive, Discharge Location

9055

:

O Home
O Nursing home

If Deceased, Death in Lab/OR9060: O No
If Deceased, Primary Cause of Death

9065

O Extended care/TCU/rehab
O Hospice
O Other

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

O Yes
: O Cardiac
O Valvular

O Neurologic
O Pulmonary

O Renal
O Unknown

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 Inhibitor
Warfarin

9100,9105

9100,9105

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

: (any) O No

O Yes

O Contraindicated

O Blinded

: (any)

:

ARB9100,9105: (any)
Aspirin

9100,9105

: (any)

9100,9105

Dabigatran

:

9100,9105

Beta Blocker

Antiarrhythmics
P2Y12

9100,9105

: (any)

9100,9105

: (any)

: (any)
9100,9105

Factor Xa inhibitor

© 2011 STS and ACCF

3/4/2015 4:28 PM

Page 5 of 8

STS/ACC TVT RegistryTM v2.0
For Transcatheter Aortic Valve Replacement Procedures
I. FOLLOW -UP (30 DAYS, 1 YEAR
Last Name

2000

FROM DATE OF

PROCEDURE)

:

First Name

Reference Procedure Start Date

6040

mm / dd / yyyy

:

Other ID

2010

:

Patient ID

2045

:

2040

:

Study Patient ID

3032

: (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 Status

10005

O Clinic

:

O Medical record

O Phone call to patient/family
Status10010:

O Alive

O Deceased

If Deceased, Primary Cause of Death

10015

O Letter from medical provider
O Social Security death master file

O Lost to follow-up

O Withdrawn

O Cardiac

O Neurologic

O Renal

O Vascular

O Valvular

O Pulmonary

O Unknown

O Other

O Other

O Infection

:

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

Creatinine10090:

10086

g/dL

o Not Drawn

NYHA Classification at Follow-up10100: O I

O II

O Not performed

If TTE, TEE, LVEF

10210

:

sec Time 210145:

If Yes, Time 110140:

O No significant changes

If New changes noted, ECG Changes Noted10160:

Echocardiogram10206: O Not Performed

10091

o Not Drawn

O III O IV

Five Meter Walk10135: O Not performed O Yes O Unable to walk
12-Lead ECG Findings10155:

mg/dL

O Yes - TEE

% o LVEF Not Assessed

O Arrhythmia

If TTE, TEE, Date

10211

sec

O New changes noted

O Pathological Q-wave or LBBB

O Yes - TTE

sec Time 310150:

10207

:

If TTE, TEE, Mean Gradient

O Both

mm / dd / yyyy

10215

: (highest)
mmHg

If TTE, TEE, Aortic Insufficiency Severity

10220

:

O None

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

O Trace/Trivial

Severity10225:

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

KCCQ-12 Performed10230:
If Yes, KCCQ-12
(See separate
questionnaire)

10231-10242

© 2011 STS and ACCF

O No
:

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

O None O Mild
O None O Mild

O Moderate
O Moderate

O Severe O Not documented
O Severe O Not documented

O Yes

Q1a:

Q1b:

Q1c:

Q5:

Q6:

Q7:

3/4/2015 4:28 PM

Q2:

Q8a:

Q3:

Q8b:

Q4:

Q8c:

Page 6 of 8

STS/ACC TVT RegistryTM v2.0
For Transcatheter Aortic Valve Replacement Procedures
I. FOLLOW -UP CONT’D (30 DAYS, 1 YEAR

FROM DATE OF PROCEDURE)

ADVERSE EVENTS, READMISSIONS, INTERVENTIONS AND SURGICAL PROCEDURES (SPECIFY THE EVENT DATE FOR EACH EVENT
BETWEEN DISCHARGE AND 30-DAY F/U, OR BETWEEN F/U ASSESSMENT DATE #1 AND F/U ASSESSMENT DATE #2.)
Follow-Up Event(s) Occurred

10245

: O No

O Yes

E059

Myocardial Infarction

:

If Yes, specify the Event

mm / dd / yyyy

10246

and Event Date(s)

Aortic Valve Re-intervention

THAT OCCURRED

10247

:

E030

:

(complete Adjudication)

mm / dd / yyyy

E031

Endocarditis

E003

:

mm / dd / yyyy

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

E040
Conduction/Native Pacer Disturbance Req ICD mm
: / dd / yyyy

Transient Ischemic Attack

E011

Ischemic Stroke

:

Hemorrhagic Stroke

E010

: (complete Adjudication)

(complete Adjudication)

E012

Undetermined Stroke

: (complete Adjudication)

E013

: (complete Adjudication)

E038

PCIE033:

mm / dd / yyyy

:

Non-Valve Related Readmission

mm / dd / yyyy

Major Vascular ComplicationE041:

mm / dd / yyyy

:

E034

:

E035

E042

Minor Vascular Complication

E014

Transapical Related Event

Major Bleeding Event
E029

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

E027

New Requirement for Dialysis

(for Bleeding or Access Site Complication)

Valve Related Readmission

:

Device Thrombosis

Unplanned Vascular Surgery or InterventionE032: mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy
Device Fracture

Unplanned Other Cardiac Surgery or Intervention
:
(not AVR or PCI)
mm / dd / yyyy

E043

:

mm / dd / yyyy
mm / dd / yyyy

mm / dd / yyyy

:

:

mm / dd / yyyy
mm / dd / yyyy

:

mm / dd / yyyy Life Threatening BleedingE037:

mm / dd / yyyy

FOLLOW-UP MEDICATIONS (MEDICATIONS PRESCRIBED OR TAKEN AT THE TIME OF FOLLOW-UP)
10250,10255

ACE Inhibitor

10250,10255

Warfarin

: O No O Yes O Contraindicated O Blinded

O No O Yes O Contraindicated O Blinded

:

10250,10255

ARB

:

O No O Yes O Contraindicated O Blinded

Aspirin10250,10255:

O No O Yes O Contraindicated O Blinded

Beta Blocker

10250,10255

:

O No O Yes O Contraindicated O Blinded

10250,10255

O Blinded

Antiarrhythmics

:O No O Yes O Contraindicated

P2Y1210250,10255: (any)

Factor Xa inhibitor

O No O Yes O Contraindicated O Blinded

10250,10255

: o O Yes O Contraindicated O Blinded
ON

10250,10255

Dabigatran

: O No O Yes O Contraindicated O Blinded

© 2011 STS and ACCF

3/4/2015 4:28 PM

Page 7 of 8

STS/ACC TVT RegistryTM v2.0
For Transcatheter Aortic Valve Replacement Procedures
J. ADJUDICATION FORM
Last Name

2000

(COMPLETE

FOR

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

:

First Name

Reference Procedure Start Date
Adjudication Event

6040

: mm / dd / yyyy

Other ID

2010

2045

2040

:

Patient ID

:
3032

Study Patient ID

:

:

(optional)

12000

:

O Ischemic Stroke(In-hospital) O Hemorrhagic Stroke(In-hospital) O Undetermined Stroke(In-hospital) O TIA(In-hospital) O Aortic Valve Re-intervention(In-hospital)
O Ischemic Stroke(F-U)
Event Date

12005

12010

Status

O Hemorrhagic Stroke(F-U)

12000

If Event

O TIA(F-U)

O Aortic Valve Re-intervention(F-U)

mm / dd / yyyy

:
O Alive

:

O Undetermined Stroke(F-U)

If Deceased, Date of Death12011:

O Deceased

mm / dd / yyyy

= Stroke or TIA

Date of Symptom Onset

12015

: (approximate)

Neurologic Deficit with Rapid Onset

mm / dd / yyyy

12020

:

O No

12025

If Yes, Clinical Presentation

:

O Stroke/TIA

If Stroke/TIA, Symptom Duration > 24 hours
If Stroke/TIA, Neuroimaging Performed
If Yes, Deficit Type12045:O No deficit

12040

12030

:

:

O Infarction

O Hemorrhage

If Stroke/TIA, Neurologist/Neurosurgeon Confirmation of Diagnosis
If Stroke/TIA, Social/Recreational Activities Impaired

12056

:

:
12057

If Stroke/TIA, Neurocognitive Functions Essential to Pt or their Livelihood Impaired
If Stroke/TIA, New Aids or Assistance Required12058:
12060

If Stroke/TIA, Death as a Result of Neurologic Deficit
:
12065
Clinical Comments
: (information and details that may assist in assessing the stroke or TIA)
If Event

12000

:

O Non-Stroke

O No

O Yes

O No

O Yes

O Both (hem/infarc)

12055

O Yes

O Subarachnoid Hemorrhage
O No

O Yes

O No

O Yes

O No

O Yes

O No

O Yes

O No

O Yes

= Aortic Valve Re-intervention
12100

Aortic Valve Re-intervention Date

:

12105

Aortic Valve Re-intervention Type

:

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

If Other Transcatheter Intervention, Type
12115

Primary Indication

:

12110

:

O Aortic insufficiency
O Endocarditis

If Aortic Insufficiency, AI Severity12120: (highest)

O Aortic stenosis
O Valve thrombosis
O None

O Trace/Trivial
12125

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

12130

If Trace/Trivial, Mild, Moderate, or Severe Central Severity
12135

If Aortic Stenosis, AS Severity
If Other, Other Indication
Comments

12140

O Transcatheter AVR
O Other Transcatheter Intervention

: (highest) O Possible stenosis

:

O Device migration
O Other

O Device fracture

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

:O None

O Mild

O Moderate

O Severe

O None

O Mild

O Moderate

O Severe

O Significant stenosis

:

Clinical

12145

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

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-XXXX
(Expires XX/XX/XXXX). The time required to complete this information collection is estimated to average [Insert Time (hours or 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.

© 2011 STS and ACCF

3/4/2015 4:28 PM

Page 8 of 8