Form CMS-10531 TVT Registry

TVT Registry™ v2.0
Transcatheter Mitral Valve Procedures – Leaflet Clip
A. DEMOGRAPHICS
Last Name2000:
SSN2030:

First Name2010:
-

□ SSN N/A2031 Patient ID2040:

-

Birth Date2050:

Sex2060:

mm / dd / yyyy

Other ID2045:

(auto)

Hispanic or Latino Ethnicity2076:

O Male O Female

□ White2070
□ American Indian/Alaskan Native2073

Race:
(check all that apply)

Middle Name2020:

□ Black/African American2071
□ Native Hawaiian/Pacific Islander2074

O No

O Yes

□ Asian2072

B. EPISODE OF CARE
Arrival Date/Time3000,3001:
Residence3003:

mm / dd / yyyy HH:MM

O Home w/no health-aid

O Home w/health-aid
3005

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

Research Study3030:

O Long-term care

O Other

3006

O Not Documented

3007

□ Military Health Care3008
□ Non-US Insurance3011 □ None3012

□ Medicare
□ Medicaid
□ Indian Health Service3010
O No

àIf Yes, Study Patient ID3032:

O Yes

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

O No

àIf Yes, Infective Endocarditis Type4005:

O Treated

O Yes
O Active

Heart Failure Hospitalization w/in Past Year4006:
O No

O Yes

O Not Documented

àIf Yes, CRT4013:
Previous ICD4015:
àIf Yes, CRT–D4016:
Prior PCI4020:
Prior CABG4030:
# Previous Cardiac Surgeries

:

Prior Aortic Valve Procedure4060:
àIf Yes, AV Replacement – Surgical
àIf Yes, AV Repair – Surgical

4080

:

:

àIf Yes, AV Transcatheter Valve
Replacement4090:

O No

O Yes – partial
O Yes – circumferential

O No

O No

O Yes

O No

O Yes

àIf Yes, MV Transcatheter Intervention4112:

O No

O Yes

àIf Yes, Mitral Transcather Type4113 :

O No

O Yes

O No

O Yes

O Yes

O No

O Yes

O No

O Yes

O No

O Yes

O No

O Yes

O Yes

àIf Yes, Mitral Annuloplasty Ring–Surgical4111:

O Yes

O No

O Yes

àIf Yes, Most Recent MV Procedure Date4097: mm / dd / yyyy

O No

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

4070

O No

àIf Yes, MV Repair – Surgical4110:

Permanent Pacemaker4010:

4055

Prior Non Aortic Valve Procedure4095:

O Leaflet clip
O Coronary sinus based intervention
O Valve-in-Valve

O Not Documented
O No

O Yes

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

àIf Yes, Prior Tricuspid Valve
Repair/Replacement4118:

O No

O Yes

àIf Yes, Prior Pulmonic Valve
Repair/Replacement4119:

O No

O Yes

O No

O Yes

OTHER HISTORY AND RISK FACTORS
Prior Stroke4120:
4125

àIf Yes, Most Recent Stroke Date
4130

Transient Ischemic Attack
4135

Carotid Stenosis

:

mm / dd / yyyy
O No

:

: O None

O Right

O Left

O Yes

Diabetes Mellitus4165:
4170

àIf Yes, Diabetes Therapy
O None

O Diet
4175

O Both O NA Currently on Dialysis

:
O Oral

O Insulin

O Other
O No

:

O Yes

àIf Yes, Prior CEA/CAS 4140:

O No

O Yes

Chronic Lung Disease4180: O None O Mild O Moderate O Severe

Peripheral Arterial Disease4145:

O No

O Yes

Home Oxygen4181:

Current Smoker
Hypertension

4150

4155

(w/in 1 year):

:

© 2011 STS and ACCF

O No
O No

O Yes
O Yes

Hostile Chest

4182

:

Immunocompromise Present

6/9/2014 11:59 AM

4185

:

O No

O Yes

O No

O Yes

O No

O Yes

Page 1 of 9

TVT Registry™ v2.0
Transcatheter Mitral Valve Procedures – Leaflet Clip
HOME MEDICATIONS
ACE or ARB (any)4200,4205 :

O No

O Yes

Diuretics – Aldosterone Antagonists4200,4205 :

O No

O Yes

Anticoagulants (any)4200,4205:

O No

O Yes

Diuretics – Loop diuretic4200,4205 :

O No

O Yes

O No

O Yes

O No

O Yes

4200,4205

Aspirin (alone)

:

O No
4200,4205

Aspirin (dual antiplatelet therapy)
4200,4205

Beta Blockers (any)

:

O No

:

àIf Loop Diuretic, Dose

O Yes
O Yes

O No

O Yes

4210

:_____mg

4200,4205

Diuretics – Thiazides

:
4200,4205

Diuretics (not otherwise specified)

:

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

O Unstable angina (60 days)
Prior MI5005:

O No
5012

Cardiomyopathy

:

O Sx unlikely to be ischemic (14 days)

O Stable angina (42 days)

O Non-STEMI (7 days)

O STEMI (7 days)

àIf Yes, Prior MI Timeframe5010:

O Yes

O < 30 Days

O >= 30 days

O Yes – Ischemic O Yes – Non-ischemic

O No

Heart Failure w/in 2 Weeks5020:

O No

O Yes

STS Risk Score (MV replace)5106: _______ %

O III

O IV

STS Risk Score (MV repair)5107:

Cardiogenic Shock w/in 24 Hours5030:

O No

O Yes

Six Minute Walk Test5115:

Cardiac Arrest w/in 24 Hours5035:

O No

O Yes

Porcelain Aorta5045:

O No

O Yes

O No

O Yes

NYHA Class w/in 2 Weeks5025:

Atrial Fibrillation/Flutter

5050

OI

O II

:

àIf Yes, AF Class w/in past 30 days5052:

O None O Persistent O Paroxysmal

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
Test Date5116:

mm / dd / yyyy
5117

KCCQ-12 Performed5169: O No
àIf Yes, KCCQ-12

5170-5181

:

_______ %

Total Distance

: ___________ ft

Q3:

O Yes

Q1a: _______

Q1b: _______

Q1c: _______

Q2:

Q5:

Q6:

Q7:

Q8a: _______

_______

_______

Q4:

_______

(See separate questionnaire)

_______

_______

_______

Q8b: _______

Q8c: _______

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

Weight5205: ___________ kg

Hemoglobin5250: _______ g/dL

□ Not Drawn5251

Creatinine5255: _______ mg/dL

□ Not Drawn5256

BNP5277: ______pg/mL

NT proBNP5278: _____pg/mL

FEV1 Predicted5280: _______ %

□ Not Performed5281

DLCO (Adjusted)5285: _______ %

□ Not Performed5286

(OR)

□ Not Drawn5279
QRS Duration5290: ________ msec

□ Ventricular Paced5291

MEDICATIONS (ADMINISTERED WITHIN 24 HOURS PRIOR TO THE PROCEDURE)
Inotropes5400,5405(positive):

© 2011 STS and ACCF

O No O Yes O Contraindicated O Blinded

6/9/2014 11:59 AM

Page 2 of 9

TVT Registry™ v2.0
Transcatheter Mitral Valve Procedures – Leaflet Clip
DIAGNOSTIC CATH FINDINGS
Number of Diseased Vessels5506:
5507

Left Main Stenosis >=50%
5565

LVEF

:

:

O None
O No

O1

O2

O3

O Yes
□ LVEF Not Assessed5566

________ %

□ Not Performed5569

Cardiac Output5567: _________ mL/min
Pulmonary Capillary Wedge Pressure5590:

_________ mmHg

□ Not Measured5591

Pulmonary Artery Pressure (mean)5593:

_________ mmHg

□ Not Measured5594

Pulmonary Artery Pressure (systolic)5596:

_________ mmHg

□ Not Measured5597

Right Atrial Pressure/CVP (mean)5598:

_________ 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 Volume5606: ____ mL (OR) LA Volume Index5607:
Aortic Regurgitation5630 (highest): O None
Aortic Stenosis5665:
5685

Mitral Valve Disease

:

O No

O Yes

O No

O Yes

_____ mL/m2

O Trace/Trivial

O 1+ (mild)

O 2+ (moderate)

O 3-4+ (severe)

àIf Yes, complete the following:

Mitral Regurgitation5695 (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:
5705

Mitral Valve Stenosis
MV Area5710:

:

O No

________ cm2

O Yes

O PISA
O Other

MV Mean Gradient5715 (highest): ________ mmHg

________ cm2

Tricuspid Regurgitation5735:

Method of Assessment5699: O 3D Planimetry
O Quantitative Doppler

O None

O Trace/Trivial

O Mild

O Moderate

O Severe

Mitral Valve Disease Etiology (check all that apply):
□ Functional Mitral Regurgitation (FMR)5745

□ Degenerative Mitral Regurgitation (DMR)5746

□ Endocarditis5748

□ Other/Indeterminate5749

àIf FMR is Yes, Functional
Type5755:

àIf DMR is Yes, Leaflet
Prolapse5760:
àIf DMR is Yes, Leaflet
Flail5765:
àIf Inflammatory is Yes,
Type5770:

© 2011 STS and ACCF

□ Post – Inflammatory5747

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
O None O Anterior
O Not Documented

O Posterior

O Bi-leaflet

O None O Anterior
O Not Documented

O Posterior

O Bi-leaflet

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

6/9/2014 11:59 AM

Page 3 of 9

TVT Registry™ v2.0
Transcatheter Mitral Valve Procedures – Leaflet Clip
ECHOCARDIOGRAM FINDINGS
Mitral Leaflet Calcification5810:

O Yes O No

O Not Documented

Leaflet Tethering5775: O None

O Anterior

O Posterior

O Yes O No

O Not Documented

5800

Mitral Annular Calcification

:

O Bi-leaflet

Carpentier’s Functional Class of Mitral Regurgitation5820: O Type I

O Type II

O Not Documented

O Type IIIa

O Type IIIb

O Not Documented

LEAFLET CLIP PROCEDURE REASONS/INDICATIONS (CHECK ALL THAT APPLY)

□ 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

àIf Unusual Extenuating Circumstance, check all that apply:

□ Right Ventricular Dysfunction w/Severe Tricuspid Regurg5907 □ Chemotherapy for Malignancy5908 □ Major Bleeding Diathesis5909
□ Immobility5910
□ Other5915

□ Severe Dementia5912

□ AIDS5911

□ High Risk of Aspiration5913

□ IMA at High Risk of Injury5914

àIf Other , Specify 5916 (provide reason why patient is prohibitive risk): _________________________

E. PROCEDURE INFORMATION (COMPLETE FOR EACH LEAFLET CLIP PROCEDURE)
Procedures
□ Transcatheter Aortic Valve Replacement6600 □ Transcatheter Mitral Valve Replacement6601 □ Mitral Leaflet Clip Procedure6602
Other Procedure Performed Concurrently6620:

O No

O Yes – PCI O Yes – Other

Operator A Name6000,6005,6010:

Operator A NPI6015:

Operator B Name6020,6025,6030:

Operator B NPI6035:

Procedure Start Date6040,6041: mm / dd / yyyy HH:MM
6055

Procedure Status

:

O Elective

O Urgent

Type of Anesthesia6110: O General anesthesia
6212

Guiding Cath Access Site

:

O Right femoral vein

Leaflet Clip Model ID 26245:
26250

Leaflet Clip Serial #
UDI

26255, 26260, 26265

Location

26270

:

Clip Deployed26275:
àIf No, Reason26280:

© 2011 STS and ACCF

mm / dd / yyyy HH:MM

O Emergency

O Moderate sedation

Steerable Guide Model ID26180: ____________
Leaflet Clip Counter26240:

Procedure Stop Date6045,6046:

O Salvage

O Epidural

O Combination

O Left femoral vein O Jugular vein

O Other vein

Steerable Guide Cath Serial Number26182: ____________

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

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

6/9/2014 11:59 AM

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

TVT Registry™ v2.0
Transcatheter Mitral Valve Procedures – Leaflet Clip
POST IMPLANT
Mitral Regurgitation26285: 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
Conversion to Open Heart Surgery26105:
Mechanical Assist Device
àIf Yes, Timing26141:
àIf Yes, Type

26142

26140

:

O IABP

O No

O Yes

O Catheter-based assist device

Cardiopulmonary Bypass Used6100:
àIf Yes, Status

O Yes

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

:

6101

O No

O Elective

:

O No

O Yes
àIf Yes, CPB Time 6105: ______mins

O Emergent

Radiation Dose Measurement Method6455: O Single Plane
Fluoroscopy Time

6460

Cumulative Air Kerma6465: _____ mGy

: _______ mins

Dose Area Product6470: _______

Procedure Room
Anesthesia
Procedure Access
Transseptal Access

O Gy-cm2 O cGy-cm2

àDAP Units6475:

Procedure Duration

O Biplane

O mGy-cm2 O µGy-M2

Start Time
Arrival Date/Time26060,26061

Stop Time

mm / dd / yyyy HH:MM

26070

26071
HH:MM Discontinuation

Induction

Vascular or TEE Access
Transseptal Access

26075

HH:MM

HH:MM Last Cath/TEE Removed

26080

26076

HH:MM

26081

HH:MM Septum Crossed

SCG in Intra-atrial Septum

26086

HH:MM

HH:MM Delivery System Retracted

Device

26091

SCG Device Removal (from fem vein)

HH:MM
26096

HH:MM

F. ADVERSE EVENTS, INTERVENTIONS AND SURGERIES (COMPLETE FOR EACH PROCEDURE. SPECIFY EVENT DATE FOR EACH EVENT OCCURRENCE.)
àIf Yes, specify the Event7301 and Event Date(s)7302:

mm / dd / yyyy

Cardiac ArrestE005:

mm / dd / yyyy

EndocarditisE003:

mm / dd / yyyy
E001

Myocardial Infarction

:

mm / dd / yyyy

Transient Ischemic AttackE010
(complete Adjudication):

mm / dd / yyyy

E011

Neuro

O Yes

Atrial Fibrillation (new onset)E006:

Ischemic Stroke
(complete Adjudication):

mm / dd / yyyy

E012

Hemorrhagic Stroke
(complete Adjudication):

mm / dd / yyyy

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

mm / dd / yyyy

Mitral Leaflet Injury
(detected during surgery)E045:

mm / dd / yyyy

Single Leaflet Device Attachment E049:

mm / dd / yyyy

Mitral Leaflet Injury
(ascertained by echo)E046:

mm / dd / yyyy

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

mm / dd / yyyy

mm / dd / yyyy

Mitral Subvalvular Injury
(ascertained by echo)E048:

mm / dd / yyyy

New Requirement for DialysisE029:

mm / dd / yyyy

© 2011 STS and ACCF

Stroke (Undetermined Type)
(complete Adjudication):

Device/Delivery System

Mitral Subvalvular Injury
(detected during surgery)E047:

Renal

Valve

Cardiac

Intra or Post Procedure Events Occurred7300: O No

Device Embolization

E050

E013

:

Delivery system
component embolizationE058:
E027

Device Thrombosis

:

Other Device/Delivery System
Related EventE028:

6/9/2014 11:59 AM

mm / dd / yyyy

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

Page 5 of 9

TVT Registry™ v2.0
Transcatheter Mitral Valve Procedures – Leaflet Clip
F. ADVERSE EVENTS, INTERVENTIONS AND SURGERIES (COMPLETE FOR EACH PROCEDURE. SPECIFY EVENT DATE FOR EACH EVENT OCCURRENCE.)

mm / dd / yyyy
:

mm / dd / yyyy

Retroperitoneal BleedingE019:

mm / dd / yyyy

Hematoma at Access Site
Bleed/Vascular

E018

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

E020

GI Bleed

:

mm / dd / yyyy

GU BleedE021:

mm / dd / yyyy

Other BleedE022:

mm / dd / yyyy

Transseptal ComplicationE052:

mm / dd / yyyy

Vascular

Bleeding at Access SiteE017:

O Yes

Major Vascular Access
Site ComplicationE041:

mm / dd / yyyy

Minor Vascular Access
Site ComplicationE042:

mm / dd / yyyy
E053

Additional Procedures

Intra or Post Procedure Events Occurred7300: O No

Mitral Valve Re-intervention
(complete Adjudication):

mm / dd / yyyy

Unplanned Other Cardiac Surgery
or InterventionE031(not MVR):

mm / dd / yyyy

Unplanned Vascular Surgery or InterventionE032
mm / dd / yyyy

(for Bleeding or Access Site Complication)

ASD Closure Due To Transseptal
CatheterizationE054:

mm / dd / yyyy

G. POST-PROCEDURE LABS AND TESTS
Lowest Hemoglobin8040: _______ g/dL
Echocardiogram8065:
Date8070:

□ Not Drawn8041

O Not Performed

O Yes - TTE

Highest Creatinine8050: ______ mg/dL

□ Not Drawn8051

àIf Yes, complete the following:

O Yes - TEE

mm / dd / yyyy

Mitral Regurgitation8075: 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: ________ cm2

Method of Assessment8125: O 3D Planimetry
O PISA
O Quantitative Doppler O Other

Mean Mitral Gradient8130: ________ mmHg
H. DISCHARGE (COMPLETE FOR EACH EPISODE OF CARE)
RBC/Whole Blood Transfusion9011: O No

O Yes

àIf Yes, # Units Transfused9012: ________ Note: Code the total # of units between start
of the procedure and discharge

Number of Hours in ICU9040:
9045

Discharge Date

________
Discharge Status9050:

: mm / dd / yyyy

àIf Alive, Discharge Location9055:

O Home
O Nursing home

àIf Deceased, Death in Lab/OR9060:

O No

àIf Deceased, Primary Cause of Death9065:

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
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’)
ACE/ARB9100,9105(any):

O No

O Yes

O Contraindicated

O Blinded

Anticoagulants (any)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

Diuretics (not otherwise specified)9100,9105:

O No

O Yes

O Contraindicated

O Blinded

Diuretics – Thiazides9100,9105:

O No

O Yes

O Contraindicated

O Blinded

9100,9105

Aspirin (alone)

:

Aspirin (dual antiplatelet therapy) 9100,9105:
9100,9105

Beta Blockers (any)

:

Diuretics – Aldosterone Antagonists9100,9105:
9100,9105

Diuretics – Loop

:

àIf Loop Diuretic, Dose9110: _____mg

© 2011 STS and ACCF

6/9/2014 11:59 AM

Page 6 of 9

STS/ACC TVT Registry·

tit'(§)

TVT Registry™ v2.0
Transcatheter Mitral Valve Procedures ­ Leaflet Clip

I. F OLLOW-UP (30 DAYS, 1 YEAR FROM DATE OF PROCEDURE)

Last Name

2000

2010
:
First Name

:

Reference Procedure Start Date 6040 :
Assessment Date

10000

Patient ID

2045
Other ID
:

:
10005

: 0 Clinic

Study Patient ID

0 Medical record

10010
: 0 Alive
Status

0 Home w/health-aid

:

~If Deceased, Date of Death

10020

0 Other

0 Other

0 Not documented

0 Withdrawn

o cardiac

0 Neurologic

0 Rena l

0 Vascular

0 Valvular

0 Pulmonary

0 Unknow n

0 Other

0 Infection

:
o Not Drawn 100~atinine 10090: _ _ _ mg/dL

Hemoglobin10085: - ­ g/dL
NYHA Classification at Follow-up

10100

0 I

:

: 0 Not Performed

Date10207:

0 Social Security death master fi le

0 Long-term care

0 Lost to follow-up

0 Deceased

~If Deceased, Primary Cause of Death10015:

LVEF10210:

3032

0 Letter from medical provider

0 Phone call to patient/family
Residence 10008 : 0 Home w/no health-aid

10206

:

(If the patient has not been discharged at 30 days, capture the 30 day F/U w hile still in the facility.)

Primary Method t o Determine Status

Ec hocardiogram

2040

0 II

0 Ill

0 Yes· TIE

o Not Drawn 10091

0 IV
~If Yes, complete the following

0 Yes- TEE

I

o LVEF Not Assessed10211

---­ %

Mitral Regurgitatio n

10300

: 0 None 0 Trace/Trivial 0 1+ (mild) 0 2+ (moderate) 0 3+ (moderate - severe)

0 4+ (severe)

Note: According to American Society of Echocardiography Guidelines

Effective Orifice A rea (EOA) or EROA

10315
:

Method of Assessment

Mean Mitral Gradiene 0030 : ____ mmHg
Left Atrial Volume

10035

10020

: 0 3D Planimetry
0 Quantitative Dopplar

0 PISA
0 Other

: _ _ mL (OR) LA Volume Index 10040 : _ _ mU m2

Left Ventric ular Internal Systo lic Dimensio n 10045:
Left Ventric ular Internal Diasto lic Dimensio n
10055
Left Ventric ular End Systolic Volume
:
Left Ventric ular End Diasto lic Volume
Tric uspid Regurgitatio n

10065

KCCQ-12 Performed10230:

:

:

0 None

:

0 No

~ If Yes, KCCQ-12 10231-10243:

10360

10050

_ _ _ _ em

o Not Measured

_ _ _ _ em

o Not Measured

_ _ _ mL

o Not measured

_ _ _ mL

o Not measured

0 Trace/Trivial

0 Mild

0 Moderate

10346
10351
10356
10361

0 Severe

0 Yes

Q1a: _ __

Q1b:

Q1 c :

Q2:

Q3:

Q4:

Q5:

Q6:

Q7:

QSa: _ __

QSb : _ __

QSc: _ __

(See separate questionnaire)

Six Minute Walk Test Perfo rmed

10380

:

o Performed
0
0
0
0

Total Distance Walked

© 2011 STS and ACCF

10090

:

Not
Not
Not
Not

performed
performed
performed
performed

­ non-card iac reason
- card iac reason
- patient not w illing to walk
by site

_ _ _ _ ft

6/9/20 14 11 :59 AM

Page 7 of 9

TVT Registry™ v2.0
Transcatheter Mitral Valve Procedures – Leaflet Clip
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
30-DAY F/U, OR BETWEEN F/U ASSESSMENT DATE #1 AND F/U ASSESSMENT DATE #2.)

BETWEEN DISCHARGE AND

O Yes

Atrial Fibrillation (new onset)E006:

mm / dd / yyyy

EndocarditisE003:

mm / dd / yyyy

Myocardial InfarctionE001:

mm / dd / yyyy

Transient Ischemic Attack
(complete Adjudication):

mm / dd / yyyy

Ischemic StrokeE011(complete Adjudication):

mm / dd / yyyy

Major Vascular Access
Site ComplicationE041:

mm / dd / yyyy

Minor Vascular Access
Site ComplicationE042:

mm / dd / yyyy

E043

Major Bleeding Event

:

mm / dd / yyyy

Life Threatening BleedingE037:

mm / dd / yyyy

E053

Mitral Valve Re-intervention

Hemorrhagic StrokeE012
(complete Adjudication):

mm / dd / yyyy

Stroke (Undetermined Type) E013
(complete Adjudication):

mm / dd / yyyy

Device Embolization E050:

mm / dd / yyyy

Single Leaflet Device Attachment

E049

:

mm / dd / yyyy

Device ThrombosisE027:

Additional Procedures

Device

Neuro

E010

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

O No

mm / dd / yyyy

Other Device Related Event

E028

:

mm / dd / yyyy

New Requirement for DialysisE029:
Renal

mm / dd / yyyy

(complete Adjudication)

mm / dd / yyyy

ASD Closure
Due To Transeptal CatheterizationE054:

mm / dd / yyyy

Unplanned Other Cardiac Surgery
or InterventionE031(not Mitral):

mm / dd / yyyy

Unplanned Vascular Surgery
or InterventionE032
(for Bleeding or Access Site Complication):

mm / dd / yyyy

E055

Readmission

Cardiac

Follow-up Events Occurred10245:

Readmission – Heart Failure
(complete Adjudication):

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

mm / dd / yyyy
E056

:

mm / dd / yyyy
mm / dd / yyyy

FOLLOW-UP MEDICATIONS (MEDICATIONS PRESCRIBED OR TAKEN AT THE TIME OF FOLLOW-UP)
ACE/ARB10250,10255(any):
Beta Blockers

10250,10255

O No O Yes O Contraindicated O Blinded

(any):

O No O Yes O Contraindicated O Blinded

Anticoagulants10250,10255(any):
Aspirin

10250,10255

O No O Yes O Contraindicated O Blinded

(alone):

O No O Yes O Contraindicated O Blinded

Aspirin (dual antiplatelet therapy) 10250,10255:
Diuretics – Aldosterone Antagonists

10250,10255

O No O Yes O Contraindicated O Blinded
:

O No O Yes O Contraindicated O Blinded

Diuretics – Loop10250,10255:
àIf Loop Diuretic, Dose

10257

O No O Yes O Contraindicated O Blinded
: _____ mg

Diuretics (not otherwise specified)10250,10255:
10250,10255

Diuretics – Thiazides

© 2011 STS and ACCF

O No O Yes O Contraindicated O Blinded

:

O No O Yes O Contraindicated O Blinded

6/9/2014 11:59 AM

Page 8 of 9

TVT Registry™ v2.0
Transcatheter Mitral Valve Procedures – Leaflet Clip
J. ADJUDICATION FORM (COMPLETE FOR EACH STROKE, TIA, MITRAL VALVE RE-INTERVENTION, OR HEART FA LURE READMISSION)
Last Name2000:

First Name2010:

Patient ID2040:

Reference Procedure Start Date6040: mm / dd / yyyy

Other ID2045:

Study Patient ID3032: (optional)

Adjudication Event12000: 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)

O Undetermined Stroke(In-hospital)

O TIA(In-hospital)

O Undetermined Stroke(F-U)

O TIA(F-U)

Event Date12005: mm / dd / yyyy
Status12010: O Alive

O Deceased

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

àIf Event12000 is Stroke or TIA
Date of Symptom Onset12015(approximate):
Neurologic Deficit with Rapid Onset
12025

àIf Yes, Clinical Presentation

:

12020

mm / dd / yyyy

: O No

O Yes

O Stroke/TIA

àIf Stroke/TIA, Symptom Duration > 24 hours
12040

àIf Stroke/TIA, Neuroimaging Performed
àIf Yes, Deficit Type12045:

O No deficit

O Non-Stroke

12030

:

:

O Infarction

O Hemorrhage

àIf Stroke/TIA, Neurologist/Neurosurgeon Confirmation of Diagnosis

12055

O Both (hem/infarc)
:

àIf Stroke/TIA, Social/Recreational Activities Impaired12056:
12057

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

:

àIf Stroke/TIA, New Aids or Assistance Required:12058:
àIf Stroke/TIA, Death as a Result of Neurologic Deficit

12060

:

O No

O Yes

O No

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

Clinical Comments12065(information and details that may assist in assessing the stroke or TIA):
àIf Event12000 is 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
àIf Other Transcatheter Intervention, Other Type12205: ______________________________________________________________
MV Reintervention Indication12210: O Mitral regurgitation
O Device embolization

O Mitral stenosis
O Endocarditis

O Mitral valve injury
O Device thrombosis

O Other

àIf Other, Other Indication12215: __________________________________________________________________________
Clinical Comments12220(information and details that may assist in assessing this re-intervention):
àIf Event12000 is Readmission (Heart Failure)
Hospitalization >=24 hours12225:
12230

Clinical Signs and/or Symptoms of Heart Failure
IV or Invasive Treatment Required12335 :

O No

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

6/9/2014 11:59 AM

Page 9 of 9