Form CMS-10531 TVT Registry

A. DEMOGRAPHICS
Last Name

2000

2010

:

First Name

SSN2030:

-

Birth Date

2050

□ SSN N/A

2031

-

Patient ID
Sex

mm / dd / yyyy

:

2040

2060

Middle Name

:

2045

(auto)

Other ID

Hispanic or Latino Ethnicity

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

2070

:

:
2076

O Male O Female

:

□ White
2073
□ American Indian/Alaskan Native

Race:
(check all that apply)

2020

:

:

O No

□ Asian

2071

O Yes

2072

B. EPISODE OF CARE
3000,3001

Arrival Date/Time
Residence

3003

:

:

mm / dd / yyyy HH:MM

O Home w/no health-aid

O Home w/health-aid

Insurance Payors: □ Private Health Insurance
(check all that apply) □ State-Specific Plan (non-Medicaid)3009
3005

3030

HIC3015:

Research Study

:

O Long-term care

O Other

□ Medicare
□ Medicaid
3010
□ Indian Health Service
3006

O No

O Yes

O Not Documented
□ Military Health Care
3011
□ Non-US Insurance

3007

3008

□ None

3012

If Yes, Study Patient ID3032:

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

4000

:

O No

If Yes, Infective Endocarditis Type

4005

:

O Treated
4006

Heart Failure Hospitalization w/in Past Year
O No
4010

Permanent Pacemaker
If Yes, CRT

O Not Documented

:

:

O No

O Yes

4015

O No

O Yes

4013

:

4016

:

:

Prior CABG4030:
# Previous Cardiac Surgeries
Prior Aortic Valve Procedure

4055

4060

:

O No

O Yes

O No

O Yes

O No

O Yes

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

:

O No

O Yes

O No

O Yes

If Yes, AV Repair – Surgical4080:

O No

O Yes

If Yes, AV Transcatheter Valve
4090
Replacement :

O No

O Yes

O No

O Yes

4070

If Yes, AV Replacement – Surgical

OTHER HISTORY
Prior Stroke

4120

:

If Yes, Most Recent Stroke Date
Transient Ischemic Attack
4135

4130

4150

Current Smoker

4155

:

:

mm / dd / yyyy
O No

: O None

Peripheral Arterial Disease

4125

:
O Right

If Yes, Prior CEA/CAS 4140:

Hypertension

:

4095

:

O No
4097

If Yes, Most Recent MV Procedure Date
4110

O No

O Yes – partial
O Yes – circumferential

O No

: mm / dd / yyyy If

:

If Yes, Mitral Annuloplasty Ring–Surgical

If Yes, MV Transcatheter Intervention
If Yes, Mitral Transcather Type
O Leaflet clip
O Coronary sinus based intervention
O Valve-in-Valve

4113

4112

O Yes

4111

O Yes

:

O Not Documented
:

O No

O Yes

:

O Direct annuloplasty intervention
O Valve-in-native Valve
O Other

If Yes, Prior Tricuspid Valve
4118
Repair/Replacement :

O No

O Yes

If Yes, Prior Pulmonic Valve
4119
Repair/Replacement :

O No

O Yes

O No

O Yes

RISK FACTORS

AND

Carotid Stenosis

Prior Non Aortic Valve Procedure

Yes, MV Repair – Surgical

:

O Yes

If Yes, CRT–D
4020

O Active

O No

Previous ICD

Prior PCI

O Yes

O Yes

4145

O Left

(w/in 1 year):

:

If Yes, Diabetes Therapy
O None

O Yes

Chronic Lung Disease

O Yes

Home Oxygen

O No

O Yes

Hostile Chest

O No

O Yes

4175

4181

4182

:
O Oral

O Insulin

O Other
O No

:

4180

O No

4170

O Diet

O Both O NA Currently on Dialysis
O No

:

O Yes

4165

Diabetes Mellitus

:

O Yes

O None O Mild O Moderate O Severe

:

:

Immunocompromise Present

4185

:

O No

O Yes

O No

O Yes

O No

O Yes

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 0938-1274 (Expires XX/XX/XXXX). The time required to
complete this information collection is estimated to average 63 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
ac©
cura2
cy0
of1
th1
e timS
eT
estiS
mate(s
ggeC
stioC
nsF
for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Re2
po/rt1
s C0le/a2
ran0
ce1O6
ffic1
er,2
M:ail44
StopP
C4M
-26-05, Baltimore, Maryland 21244-1850. ****CMS Disclosure**** Please do not sendP
apa
plig
cate
ions1
, claoimfs,9
payments, medical
an) odr suA
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.

HOME

MEDICATIONS
4200,4205

ACE or ARB (any)

:

4200,4205

Anticoagulants (any)
Aspirin (alone)

4200,4205

:

:
4200,4205

Aspirin (dual antiplatelet therapy)
Beta Blockers (any)

4200,4205

:

:

CAD Presentation

O Yes

Diuretics – Aldosterone Antagonists

O No

O Yes

Diuretics – Loop diuretic

O No

O Yes

O No

O Yes

O No

D. PRE-PROCEDURE STATUS (COMPLETE FOR THE
5000

O No

Prior MI

: O No Sxs, no angina (14 days)

O No

:

5012

Cardiomyopathy

:

O Yes
O No

Heart Failure w/in 2 Weeks
NYHA Class w/in 2 Weeks

5050

OI

5035

5030

4200,4205

:
4200,4205

Diuretics (not otherwise specified)

5010

:

O < 30 Days

:

O II

:

:
5052

5106

O No

O Yes

STS Risk Score (MV replace)

O III

O IV

STS Risk Score (MV repair)

O No

O Yes

O No

O Yes

O No

O Yes

O No

O Yes

5115

Six Minute Walk Test

O No

O Yes

O None O Persistent O Paroxysmal

:

: O No

5170-5181

:

5107

:

%

:

%

:

O Performed
O Not performed – non-cardiac reason
O Not performed – cardiac reason
O Not performed – patient not willing to walk
O Not performed by site
5116

mm / dd / yyyy

:

5117

If Yes, KCCQ-12

O Yes

O >= 30 days

Test Date

5169

O No

mg

O STEMI (7 days)

:

If Yes, AF Class w/in past 30 days

KCCQ-12 Performed

O Yes

O Non-STEMI (7 days)

:

Atrial Fibrillation/Flutter

O No

O Stable angina (42 days)

:

:

Cardiac Arrest w/in 24 Hours
Porcelain Aorta

:

O Yes

O Sx unlikely to be ischemic (14 days)

àIf Yes, Prior MI Timeframe

Cardiogenic Shock w/in 24 Hours

5045

Diuretics – Thiazides

:

4210

O No

O Yes – Ischemic O Yes – Non-ischemic

5020

5025

If Loop Diuretic, Dose

:

PROCEDURE)

O Unstable angina (60 days)
5005

O Yes

4200,4205

4200,4205

Total Distance

:

ft

O Yes

Q1a:

Q1b:

Q1c:

Q2:

Q3:

Q4:

Q5:

Q6:

Q7:

Q8a:

Q8b:

Q8c:

(See separate questionnaire)

CLINICAL DATA (CLOSEST TO THE
Height

5200

:

PROCEDURE)
5205

Weight

cm
5255

Creatinine

FEV1 Predicted

5280

5285

DLCO (Adjusted)

□ Not Performed

%

:
:

%

5400,5405

(positive):

© 2011 STS and ACCF

Hemoglobin
5277

BNP

:

5250

:
pg/mL

g/dL

(OR)

□ Not Drawn5251
5278

NT proBNP

□ Not Drawn

5281

□ Not Performed5286

MEDICATIONS (ADMINISTERED WITHIN 24 HOURS PRIOR TO THE
Inotropes

kg

□ Not Drawn5256

mg/dL

:

:

QRS Duration5290:

msec

:

pg/mL

5279

□ Ventricular Paced5291

PROCEDURE)

O No O Yes O Contraindicated O Blinded

2/10/2016 12:44 PM

Page 2 of 9

DIAGNOSTIC CATH FINDINGS
Number of Diseased Vessels
5507

Left Main Stenosis >=50%
LVEF

5565

5506

:

:

O None
O No

O1

O2

O3

O Yes
□ LVEF Not Assessed5566

%

:

Cardiac Output

5567

□ Not Performed5569

L/min

:

Pulmonary Capillary Wedge Pressure

5590

5593

Pulmonary Artery Pressure (mean)

Pulmonary Artery Pressure (systolic)
5598

Right Atrial Pressure/CVP (mean)

:

:

5596

:

:

mmHg

□ Not Measured5591

mmHg

□ Not Measured5594

mmHg

□ Not Measured5597

mmHg

□ Not Measured5599

ECHOCARDIOGRAM FINDINGS
Left Ventricular Internal Systolic Dimension5595:

cm

□ Not Measured5608

Left Ventricular Internal Diastolic Dimension5600:

cm

□ Not Measured5609

Left Ventricular End Systolic Volume5601:

ml

□ Not Measured5602

Left Ventricular End Diastolic Volume5603:

ml

□ Not Measured5604

Left Atrial Volume

5606

Aortic Regurgitation
5665

Aortic Stenosis

:

mL (OR) LA Volume Index

5630

(highest): O None

:
5685

Mitral Valve Disease

Mitral Regurgitation

:

5695

O No

O Yes

O No

O Yes

5607

mL/m2

:

O Trace/Trivial

O 1+ (mild)

O 2+ (moderate)

O 3-4+ (severe)

If Yes, complete the following:

(highest): O None O Trace/Trivial O 1+ (mild) O 2+ (moderate) O 3+ (moderate – severe)

O 4+ (severe)

Note: According to American Society of Echocardiography Guidelines

Effective Orifice Area (EOA) or EROA 5698:
Mitral Valve Stenosis
MV Area

5710

5705

:

O No

2

cm

O Yes

5735

Tricuspid Regurgitation

:

: O 3D Planimetry
O Quantitative Doppler

MV Mean Gradient5715 (highest):

cm2

:

5699

Method of Assessment

O None

O Trace/Trivial

O Mild

O Moderate

O PISA
O Other

mmHg

O Severe

Mitral Valve Disease Etiology (check all that apply):
□ Functional Mitral Regurgitation (FMR)
□ Endocarditis

5745

5746

□ Other/Indeterminate

5748

If FMR is Yes, Functional
Type5755:

□ Degenerative Mitral Regurgitation (DMR)

□ Post – Inflammatory

5747

5749

O Ischemic-acute, post infarction O Ischemic-chronic
O Non-ischemic dilated cardiomyopathy
O Restrictive cardiomyopathy
O Hypertrophic cardiomyopathy
O Pure annular dilation (w/normal LV systolic fx)
O Not Documented

If DMR is Yes, Leaflet
Prolapse5760:

O None O Anterior
O Not Documented

O Posterior

O Bi-leaflet

O None O Anterior
O Not Documented

O Posterior

O Bi-leaflet

If DMR is Yes, Leaflet
Flail5765:
If Inflammatory is Yes,
Type5770:

© 2011 STS and ACCF

O Idiopathic
O Prior radiation Rx
O Collagen vascular disease
O Drug induced O Rheumatic fever history O Not Documented

2/10/2016 12:44 PM

Page 3 of 9

ECHOCARDIOGRAM FINDINGS
5810

Mitral Leaflet Calcification
Leaflet Tethering

5775

:

: O None
5800

Mitral Annular Calcification

O Yes O No

O Not Documented

O Anterior

O Posterior

O Yes O No

O Not Documented

:

5820

Carpentier’s Functional Class of Mitral Regurgitation
LEAFLET CLIP PROCEDURE REASONS/INDICATIONS (CHECK

O Bi-leaflet

: O Type I

ALL THAT APPLY

O Type II

O Not Documented

O Type IIIa

O Type IIIb

O Not Documented

– AT LEAST ONE INDICATION SHOULD BE SELECTED)

□ Frailty5900 (assessed by in-person cardiac surgeon consultation)

□ Hostile Chest5901

□ Severe Liver Disease (Cirrhosis or MELD score >12)5902

□ Porcelain Aorta5903 (or extensively calcified ascending aorta)

□ Predicted STS MV Repair Operative Mortality Risk of >=6% (for patients deemed likely to undergo MV repair)5905
□ Predicted STS MV Replacement Operative Mort Risk >=8% (for patients deemed likely to undergo MV replacement)5904
□ Unusual Extenuating Circumstance5906

If Unusual Extenuating Circumstance, check all that apply:

□ Right Ventricular Dysfunction w/Severe Tricuspid Regurg5907

□ Chemotherapy for Malignancy5908 □ Major Bleeding Diathesis5909

□ Immobility5910

□ High Risk of Aspiration5913

□ Other5915

□ Severe Dementia5912

□ AIDS5911
If Other , Specify

5916

□ IMA at High Risk of Injury5914

(provide reason why patient is prohibitive risk):

E. PROCEDURE INFORMATION (COMPLETE FOR EACH LEAFLET CLIP PROCEDURE)
Procedures
□ Transcatheter Aortic Valve Replacement

6600

6620

Other Procedure Performed Concurrently
Operator A Name

6000,6005,6010

Operator B Name

:

Procedure Status

6040,6041

:

6110

: mm / dd / yyyy HH:MM

6212

:

26180

Steerable Guide Model ID
26240

Leaflet Clip Counter

Leaflet Clip Model ID

26245

26250

Leaflet Clip Serial #
26255, 26260, 26265
26270

:

Clip Deployed

26275

If No, Reason

:
:

O Urgent

:

© 2011 STS and ACCF

Procedure Stop Date6045,6046:

6015

:

6035

:

mm / dd / yyyy HH:MM

O Emergency

O Moderate sedation

O Right femoral vein

O Salvage

O Epidural

O Combination

O Left femoral vein O Jugular vein

O Other vein
26182

:

Steerable Guide Cath Serial Number

:

Leaflet Clip #1

Leaflet Clip #2

Leaflet Clip #3

Refer to Device List

Refer to Device List

Refer to Device List

(future)

(future)

(future)

O A1P1
O A2P2
O A3P3

O A1P1
O A2P2
O A3P3

O A1P1
O A2P2
O A3P3

:

O No

:

26280

6602

Operator B NPI

: O General anesthesia

Guiding Cath Access Site

□ Mitral Leaflet Clip Procedure

Operator A NPI

O Elective

Type of Anesthesia

6601

O Yes – PCI O Yes – Other

:

6055

Location

O No

6020,6025,6030

Procedure Start Date

UDI

:

□ Transcatheter Mitral Valve Replacement

O Yes

O Inability to grasp leaflets
O Inability to reduce MR
O Mitral stenosis
O MV injury
O Device malfunction
O Adverse event
O Other

O No

O Yes

O Inability to grasp leaflets
O Inability to reduce MR
O Mitral stenosis
O MV injury
O Device malfunction
O Adverse event
O Other

2/10/2016 12:44 PM

O No

O Yes

O Inability to grasp leaflets
O Inability to reduce MR
O Mitral stenosis
O MV injury
O Device malfunction
O Adverse event
O Other

Page 4 of 9

POST IMPLANT
Mitral Regurgitation

26285

: O None O Trace/Trivial O 1+ (mild) O 2+ (moderate) O 3+ (moderate – severe)

O 4+ (severe)

Note: According to American Society of Echocardiography Guidelines

MV Mean Gradient26290:

mmHg
26105

Conversion to Open Heart Surgery
Mechanical Assist Device
If Yes, Timing
If Yes, Type

26141

26142

:

26140

:

O IABP

Cardiopulmonary Bypass Used
If Yes, Status

6100

O No

O Yes

O No

:

6460

:

O Yes

O Emergent

Radiation Dose Measurement Method

Dose Area Product

O Yes

O Catheter-based assist device

O Elective

:

Fluoroscopy Time

O No

O Pre-procedure O Intra-procedure O Post-procedure

:

6101

:

6455

If Yes, CPB Time

: O Single Plane

mins

6470

:

DAP Units

Procedure Duration

6475

6105

:

mins

O Biplane

Cumulative Air Kerma

6465

2

2

:

O Gy-cm

O cGy-cm

:

mGy
O mGy-cm

2

2

O µGy-M

Start Time
Arrival Date/Time

Procedure Room

26060,26061

mm / dd / yyyy HH:MM

26070

Anesthesia

Induction

Procedure Access

Vascular or TEE Access26075
Transseptal Access

Transseptal Access

Stop Time

26080

26071
HH:MM Discontinuation

HH:MM

26076
HH:MM Last Cath/TEE Removed

HH:MM

26081

HH:MM Septum Crossed

SCG in Intra-atrial Septum26086

HH:MM

26091
HH:MM Delivery System Retracted

HH:MM

Device

26096

SCG Device Removal (from fem vein)
F. ADVERSE EVENTS, INTERVENTIONS AND SURGERIES (COMPLETE FOR EACH PROCEDURE. SPECIFY EVENT DATE FOR EACH EVENT
7300

Intra or Post Procedure Events Occurred
E006

Atrial Fibrillation (new onset)

E003

mm / dd / yyyy

:

mm / dd / yyyy
E059

:

mm / dd / yyyy

Valve

Perforation
E009
(w/ or w/o Tamponade) :

and Event Date(s)

Transient Ischemic Attack
(complete Adjudication):

mm / dd / yyyy

:

Myocardial Infarction

If Yes, specify the Event

mm / dd / yyyy

Ischemic Stroke
(complete Adjudication):

mm / dd / yyyy

E012

Hemorrhagic Stroke
(complete Adjudication):

mm / dd / yyyy

Stroke (Undetermined Type)
(complete Adjudication):

mm / dd / yyyy

E013

mm / dd / yyyy

mm / dd / yyyy

Single Leaflet Device Attachment

Mitral Leaflet Injury
E046
(ascertained by echo) :

mm / dd / yyyy

Complete Detachment of Leaflet Clip
E051
(from valve leaflets) :

Mitral Subvalvular Injury
E047
(detected during surgery) :

mm / dd / yyyy

Mitral Subvalvular Injury
E048
(ascertained by echo) :

mm / dd / yyyy

Renal

© 2011 STS and ACCF

E029

:

mm / dd / yyyy

:

E010

Mitral Leaflet Injury
E045
(detected during surgery) :

New Requirement for Dialysis

OCCURRENCE.)

7302

E011

Device/Delivery System

Cardiac

Endocarditis

O Yes

Neuro

E005

Cardiac Arrest

:

: O No

7301

HH:MM

Device Embolization

E050

:

Delivery system
E058
component embolization :
E027

Device Thrombosis

:

Other Device/Delivery System
E028
Related Event :

2/10/2016 12:44 PM

E049

:

mm / dd / yyyy
mm / dd / yyyy
mm / dd / yyyy
mm / dd / yyyy
mm / dd / yyyy
mm / dd / yyyy

Page 5 of 9

F. ADVERSE EVENTS, INTERVENTIONS AND SURGERIES (COMPLETE FOR EACH PROCEDURE. SPECIFY EVENT DATE FOR EACH EVENT OCCURRENCE.)

E017

:

mm / dd / yyyy

E018

:

mm / dd / yyyy

:

mm / dd / yyyy

Hematoma at Access Site

E019

Bleed/Vascular

Retroperitoneal Bleeding
GI Bleed

E020

GU Bleed

:

mm / dd / yyyy

E021

:

mm / dd / yyyy

E022

Other Bleed

:

mm / dd / yyyy
E052

Transseptal Complication

G. POST-PROCEDURE

8065

Echocardiogram
8070

:

mm / dd / yyyy

Major Vascular Complication

E041

Minor Vascular Complication

:

E042

mm / dd / yyyy

:

mm / dd / yyyy

E053

Mitral Valve Re-intervention
(complete Adjudication):

mm / dd / yyyy

Unplanned Other Cardiac Surgery
E031
or Intervention
(not MVR):

mm / dd / yyyy

Unplanned Vascular Surgery or Intervention

E032

(for Bleeding or Access Site Complication):

mm / dd / yyyy

ASD Closure Due To Transseptal
E054
Catheterization :

mm / dd / yyyy

LABS AND TESTS

Lowest Hemoglobin

Date

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

O Yes

Vascular

Bleeding at Access Site

: O No

Additional Procedures

7300

Intra or Post Procedure Events Occurred

8040

:

□ Not Drawn

g/dL

O Not Performed

:

O Yes - TTE

8041

Highest Creatinine

O Yes - TEE

8050

:

□ Not Drawn

mg/dL

8051

If Yes, complete the following:

mm / dd / yyyy

:

Mitral Regurgitation

8075

: O None O Trace/Trivial O 1+ (mild) O 2+ (moderate) O 3+ (moderate – severe)

O 4+ (severe)

Note: According to American Society of Echocardiography Guidelines

Effective Orifice Area (EOA) or EROA 8122:
8130

Mean Mitral Gradient

:

cm2

Method of Assessment

mmHg

8125

: O 3D Planimetry
O PISA
O Quantitative Doppler O Other

H. DISCHARGE (COMPLETE FOR EACH EPISODE OF CARE)
RBC/Whole Blood Transfusion
9040

Number of Hours in ICU
Discharge Date

9045

9011

: O No

O Yes

If Yes, # Units Transfused

9012

:

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

:
9050

: mm / dd / yyyy

If Alive, Discharge Location9055:

Discharge Status
O Home
O Nursing home

9060

If Deceased, Death in Lab/OR

:

O No

:

O Alive

O Deceased

O Extended care/TCU/rehab
O Hospice
O Other

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

O Yes

If Deceased, Primary Cause of Death9065:

O Cardiac
O Valvular

O Neurologic
O Pulmonary

O Renal
O Unknown

O Vascular
O Other

O Infection

DISCHARGE MEDICATIONS (NOT REQUIRED FOR PTS WHO EXPIRED OR WERE DISCHARGED TO ‘OTHER ACUTE CARE HOSPITAL’, ‘HOSPICE’, OR ‘AMA’)
9100,9105

ACE/ARB

(any):

Anticoagulants (any)9100,9105
Aspirin (alone)

9100,9105

:

Aspirin (dual antiplatelet therapy)
Beta Blockers (any)

9100,9105

9100,9105

:

Diuretics – Aldosterone Antagonists
9100,9105

Diuretics – Loop

If Loop Diuretic, Dose

:

9100,9105

:

9110

:

Diuretics (not otherwise specified)
9100,9105

© 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

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

mg
9100,9105

Diuretics – Thiazides

:

O No

:

:
2/10/2016 12:44 PM

Page 6 of 9

I. FOLLOW-UP (30 DAYS, 1 YEAR FROM DATE OF PROCEDURE)
Last Name

2000

2010

:

First Name

Reference Procedure Start Date
Assessment Date

10000

6040

2045

:

mm / dd / yyyy Other ID

2040

:

Patient ID

3032

:

Study Patient ID

O Medical record

Status

10010

: O Home w/no health-aid

: O Alive

O Home w/health-aid

O Deceased

If Deceased, Date of Death
Hemoglobin

Date10207:
LVEF

10210

O Not documented

O Cardiac

O Neurologic

O Renal

O Vascular

O Valvular

O Pulmonary

O Unknown

O Other

O Infection

: mm / dd / yyyy
□ Not Drawn
10100

Echocardiogram

O Other

O Other

10020

NYHA Classification at Follow-up
10206

O Long-term care
O Withdrawn

g/dL

:

O Social Security death master file

O Lost to follow-up

If Deceased, Primary Cause of Death10015:

10085

(optional)

O Letter from medical provider

O Phone call to patient/family
Residence

:

: 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: O Clinic

10008

:

:

OI

: O Not Performed

O II

O III

Creatinine10090:

10086

□ Not Drawn

mg/dL

10091

O IV

O Yes - TTE

O Yes - TEE

If Yes, complete the following

mm / dd / yyyy
%

:

Mitral Regurgitation

10300

□ LVEF Not Assessed

10211

: O None O Trace/Trivial O 1+ (mild) O 2+ (moderate) O 3+ (moderate – severe)

O 4+ (severe)

Note: According to American Society of Echocardiography Guidelines

Effective Orifice Area (EOA) or EROA 10315:
Mean Mitral Gradient

10330

10335

Left Atrial Volume

cm2

mmHg

:

10340

:

mL (OR) LA Volume Index

Left Ventricular Internal Systolic Dimension

10345

Left Ventricular Internal Diastolic Dimension
10355

Left Ventricular End Systolic Volume

Left Ventricular End Diastolic Volume
10365

Tricuspid Regurgitation
KCCQ-12 Performed
If Yes, KCCQ-12

10230

:

10231-10243

:

:

10350

10360

:

mL/m

□ Not Measured10346

:

□ Not Measured10351

cm

:
mL

□ Not measured

mL

□ Not measured

O Trace/Trivial

O PISA
O Other

2

cm

:

O None

O No

:

Method of Assessment10320: O 3D Planimetry
O Quantitative Dopplar

10356
10361

O Mild

O Moderate

O Severe

O Yes

Q1a:

Q1b:

Q1c:

Q2:

Q3:

Q4:

Q5:

Q6:

Q7:

Q8a:

Q8b:

Q8c:

(See separate questionnaire)

Six Minute Walk Test Performed10380: O Performed
O Not performed – non-cardiac reason
O Not performed – cardiac reason
O Not performed – patient not willing to walk
O Not performed by site
10385

Test Date

:

mm / dd / yyyy

Total Distance Walked

© 2011 STS and ACCF

10390

:

ft

2/10/2016 12:44 PM

Page 7 of 9

I. FOLLOW-UP (CONT.) (30 DAYS, 1 YEAR FROM DATE OF PROCEDURE)
ADVERSE EVENTS, READMISSIONS, INTERVENTIONS AND SURGICAL PROCEDURES
10245

:

O No

Cardiac

E006

Atrial Fibrillation (new onset)
Endocarditis

E003

mm / dd / yyyy
E059

:

Transient Ischemic Attack
(complete Adjudication):
Neuro

mm / dd / yyyy

:

Myocardial Infarction

Ischemic Stroke

E011

mm / dd / yyyy
E010

mm / dd / yyyy

(complete Adjudication):
E012

Device Embolization

mm / dd / yyyy

E050

E013

mm / dd / yyyy

:

mm / dd / yyyy

Single Leaflet Device Attachment
Device Thrombosis

E027

E049

:

mm / dd / yyyy

:
E028

:

mm / dd / yyyy

E029

:

mm / dd / yyyy

Renal

New Requirement for Dialysis

FOLLOW-UP MEDICATIONS (MEDICATIONS PRESCRIBED OR TAKEN AT THE TIME OF

Beta Blockers

Aspirin

E043

Major Bleeding Event

10250,10255

mm / dd / yyyy
mm / dd / yyyy

E037

:

mm / dd / yyyy
mm / dd / yyyy

ASD Closure
E054
Due To Transeptal Catheterization :

mm / dd / yyyy

Unplanned Other Cardiac Surgery
E031
or Intervention (not Mitral):

mm / dd / yyyy

Unplanned Vascular Surgery
E032
or Intervention
(for Bleeding or Access Site Complication):

mm / dd / yyyy

E055

Readmission – Heart Failure
(complete Adjudication):

mm / dd / yyyy
E056

Readmission – Cardiac (not HF)
Readmission – Non-Cardiac
E057
(Follow Up) :

:

mm / dd / yyyy
mm / dd / yyyy

FOLLOW-UP)

O No O Yes O Contraindicated O Blinded
O No O Yes O Contraindicated O Blinded
10250,10255

:

10250,10255

O No O Yes O Contraindicated O Blinded
:

O No O Yes O Contraindicated O Blinded

:

10257

O No O Yes O Contraindicated O Blinded
:

mg
10250,10255

Diuretics (not otherwise specified)

:

O No O Yes O Contraindicated O Blinded

10250,10255

© 2011 STS and ACCF

:

O No O Yes O Contraindicated O Blinded

Diuretics – Aldosterone Antagonists

Diuretics – Thiazides

mm / dd / yyyy

O No O Yes O Contraindicated O Blinded

Aspirin (dual antiplatelet therapy)

If Loop Diuretic, Dose

E042

:

E053

(any):

10250,10255

:

10247

(complete Adjudication):

(alone):

Diuretics – Loop

E041

:

Life Threatening Bleeding

(any):

10250,10255

and Event Date(s)

Minor Vascular Complication

(any):

Anticoagulants

10246

Major Vascular Complication

10250,10255

10250,10255

OCCURRED BETWEEN

Mitral Valve Re-intervention

mm / dd / yyyy

Other Device Related Event

ACE/ARB

If Yes, specify the Event

mm / dd / yyyy

Hemorrhagic Stroke
(complete Adjudication):

Stroke (Undetermined Type)
(complete Adjudication):

Device

:

O Yes

Bleeding/Vascular

Follow-up Events Occurred

(SPECIFY THE EVENT DATE FOR EACH EVENT THAT
#2.)

ASSESSMENT DATE #1 AND F/U ASSESSMENT DATE

Additional Procedures

F/U, OR BETWEEN F/U

Readmission

DISCHARGE AND 30-DAY

:

O No O Yes O Contraindicated O Blinded

2/10/2016 12:44 PM

Page 8 of 9

J. ADJUDICATION FORM (COMPLETE FOR EACH STROKE, TIA, MITRAL VALVE RE-INTERVENTION, OR HEART FAILURE READMISSION)
Last Name

2000

:

First Name

Reference Procedure Start Date
Adjudication Event

12000

6040

2010

2045

: mm / dd / yyyy

Other ID

2040

:

Patient ID

3032

:

Study Patient ID

: O Ischemic Stroke(In-hospital) O Hemorrhagic Stroke(In-hospital)
O Mitral Valve Re-intervention(In-hospital)
O Ischemic Stroke(F-U)
O Hemorrhagic Stroke(F-U)
O Mitral Valve Reintervention(F-U)
O Readmission – Heart Failure (F-U)

Event Date
Status

12005

: O Alive

12000

IS

O Deceased

If Deceased, Date of Death

O Undetermined Stroke(In-hospital)

O TIA(In-hospital)

O Undetermined Stroke(F-U)

O TIA(F-U)

12011

: mm / dd / yyyy

STROKE OR TIA

Date of Symptom Onset12015(approximate):
Neurologic Deficit with Rapid Onset
12025

If Yes, Clinical Presentation

12020

:

mm / dd / yyyy

: O No

O Yes

O Stroke/TIA

If Stroke/TIA, Symptom Duration > 24 hours
If Stroke/TIA, Neuroimaging Performed
If Yes, Deficit Type

12045

:

12040

O Non-Stroke

12030

:

:

O No deficit

O Infarction

O Hemorrhage

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

12056

12055

O Both (hem/infarc)

:

:
12057

If Stroke/TIA, Neurocognitive Functions Essential to Pt or their Livelihood Impaired:
12058

Stroke/TIA, New Aids or Assistance Required:

:

12060

Clinical Comments
IF EVENT

IS

12065

O No

O Yes

O No

O Yes

O Subarachnoid Hemorrhage
O No

O Yes

O No

O Yes

O No

:

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

12000

: (optional)

: mm / dd / yyyy

12010

IF EVENT

:

:

O Yes If

O No

O Yes

O No

O Yes

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

MITRAL VALVE RE-INTERVENTION

Mitral Valve Re-intervention Type12200: O Surgical MV Repair
O Surgical MV Replacement O Transcatheter MV Repair
O Transcatheter MV Replacement O Leaflet Clip Procedure O Other Transcath Intervention
If Other Transcatheter Intervention, Other Type
MV Reintervention Indication

If Other, Other Indication
Clinical Comments
IF EVENT

12000

IS

12220

12210

12205

:

: O Mitral regurgitation
O Device embolization

O Mitral stenosis
O Endocarditis

O Mitral valve injury
O Device thrombosis

O Other

12215

:

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

READMISSION (HEART FAILURE)
12225

Hospitalization >=24 hours

:

O No
12230

Clinical Signs and/or Symptoms of Heart Failure
IV or Invasive Treatment Required

12335

:

O Yes

O Information not available

: O No O Yes O Information not available
O No

O Yes

O Information not available

Note: IV includes diuretics or vasoactive therapy and Invasive includes ultrafiltration, IABP, or mechanical assistance

© 2011 STS and ACCF

2/10/2016 12:44 PM

Page 9 of 9