Form CMS-10531 TVT Registry

STS/ACC TVT REGISTRY V3.0
TRANSCATHETER MITRAL VALVE REPAIR – MITRAL LEAFLET CLIP PROCEDURE (TMVr)
A. DEMOGRAPHICS
Last Name2000:
Birth Date2050:
Other ID

2045

First Name2010:
SSN 2030:

mm / dd / yyyy

2060

:

Race:
(check all that apply)

Sex

□ White2070
□ Asian2072

:

Middle Name2020:

-

□ SSN N/A2031

-

O Male

 If Yes,

Patient Zip Code

:

□

Zip Code N/A2066

□ American Indian/Alaskan Native2073

□ Asian Indian2080 □ Chinese2081 □ Filipino2082 □ Japanese2083 □ Korean2084 □ Vietnamese2085 □ Other2086

□ Native Hawaiian/Pacific Islander2074
Hispanic or Latino Ethnicity2076:

(auto)
2065

O Female

□ Black/African American2071

Patient ID2040:

O No

 If Yes,

□ Native Hawaiian2090 □ Guamanian or Chamorro2091 □ Samoan2092 □ Other Island2093

O Yes

□ Mexican, Mexican-American, Chicano2100

 If Yes, Ethnicity Type:

□ Puerto Rican2101

(check all that apply)

□ Cuban2102

□ Other Hispanic, Latino or Spanish Origin2103

B. EPISODE OF CARE
Arrival Date/Time3001: mm / dd / yyyy / hh:mm
Last Name, First Name, MI, NPI
Admitting Provider’s Name, NPI3050,3051,3052,3053: _____________________________
Last Name, First Name, MI, NPI
Last Name, First Name, MI, NPI
Attending Provider’s Name, NPI3055,3056,3057,3058: _____________________________,
_____________________________

Health Insurance3005: O No
 If Yes, Payment Source3010:
(Select all that apply)

O Yes

□ Private Health Insurance
□ Medicaid
□ Indian Health Service

□ Medicare (Fee-For-Service)
□ Military Health Care
□ Non-US Insurance

□ Medicare Advantage
□ State-Specific Plan (non-Medicaid)

MBI #12846:
Residence13803:

O Home with No Health Aid

O Home with Health Aid

O Long Term Care

O Other

□ Not Documented13804

RESEARCH STUDY
Patient Enrolled in Research Study3020:

O No

□ Patient Restriction3035

O Yes

 If Yes, Research Study Name3025, Research Study Patient ID3030:

_______, _______

TRANSCATHETER VALVE THERAPY (TVT) PATHWAY
TVT Pathway13171:

□ TAVR

□ TMVr

□ TMVR

□ Tricuspid Valve Procedure

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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). This is a mandatory information collection. The time required to complete this information collection is estimated to average 90 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
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reviewed, forwarded, or retained. If you have questions or concerns regarding where to submit your documents, please contact Sarah Fulton at
[email protected].
© 2021 STS and ACCF

26-Jan-2021

Page 1 of 12

STS/ACC TVT REGISTRY V3.0
TRANSCATHETER MITRAL VALVE REPAIR MITRAL LEAFLET CLIP PROCEDURE (TMVr)
C. HISTORY AND RISK FACTORS
Height 6000:

_______ cm

_______ kg

Weight6005:
13697

Number of Prior Open Heart Cardiac Surgeries

13707

Heart Failure Hospitalization Within Past Year
Oxygen at Home13881:
13882

Immunocompromise Present

:

:

:

____ (If the patient has had >4 prior surgeries and the number is not known, code 4 prior surgeries)

O No

O No

O Yes

O No

O Yes

O Yes □ Not Documented14253

Currently on Dialysis 13880

O No

O Yes

Tobacco Use4625: O Never O Former O Current-Every Day O Current-Some Days O Smoker – Current Status Unk O Unk if ever smoked
If any Current, Tobacco Type 4626(Select all that apply):
If Current Every Day and Cigarettes, Amount

□ Cigarettes □ Cigars
4627

:

□ Pipe

O Light tobacco use (<10/day)

□ Smokeless
O Heavy tobacco use (>=10/day)

HOME MEDICATIONS
MEDICATION CODE12297

CATEGORY

MED
PRESCRIBED

ACE Inhibitors (Angiotensin Converting Enzyme)

Angiotensin Converting Enzyme Inhibitor

O No

O Yes

Aldosterone Antagonist

Aldosterone Antagonist

O No

O Yes

Angiotensin Receptor-Neprilysin Inhibitor

Angiotensin Receptor-Neprilysin Inhibitor

O No

O Yes

Anticoagulant

Anticoagulant

O No

O Yes

Antiplatelet

Aspirin

O No

O Yes

ARB (Angiotensin Receptors Blockers)

Angiotensin II Receptor Blocker

O No

O Yes

Beta Blockers

Beta Blocker

O No

O Yes

Diuretics

Diuretics Not Otherwise Specified

O No

O Yes

Loop Diuretics

O No

O Yes

No

O Yes

Thiazides
P2Y12 Inhibitors

P2Y12 Antagonist

O No

O Yes

Selective Sinus Node I/f Channel Inhibitor

Selective Sinus Node I/f Channel Inhibitor

O No

O Yes

© 2021 STS and ACCF

26-Jan-2021

LOOP
DIURETIC
DOSE

_____ mg

Page 2 of 12

STS/ACC TVT REGISTRY V3.0
TRANSCATHETER MITRAL VALVE REPAIR MITRAL LEAFLET CLIP PROCEDURE (TMVr)
CONDITION AND PROCEDURE HISTORY INFORMATION (PATIENT HISTORY AND RISK FACTORS UP TO THE PROCEDURE)
CONDITION HISTORY12903

14264

OCCURRENCE

DATE14251

NO

YES

Atrial Fibrillation

O

O

O Paroxysmal O Persistent
If Yes, AFib Class13179:
O Long-standing Persistent O Permanent
If Parox or persis, Recent AF (w/in 30 days)14244:O No O Yes

Atrial Flutter

O

O

If Yes, Recent Aflutter (w/in 30 days)14245:

Cardiomyopathy

O

O

 If Yes, CM Type4570: □ Ischemic

O No

O Yes

□ Non-ischemic □ Other
14265

O Yes
: O No
O
Right
O
Left
O
Bilateral
:
□ Location Not Documented14329

 If Yes, Current Carotid Artery Stenosis
14230

Carotid Artery Stenosis

O

O

Cerebrovascular Accident (any)

O

O

Cerebrovascular Disease

O

O

Chronic Lung Disease

O

O

Dementia - Moderate to Severe

O

O

Diabetes Mellitus

O

O

 If Yes, Therapy14231:O None O Diet O Oral O Insulin O Other

Endocarditis

O

O

 If Yes, Type14232:

Heart Failure

O

O

Hostile Chest
Hypertension

O
O

O
O

Liver Disease

O

O

Myocardial Infarction

O

O

Peripheral Arterial Disease
Porcelain Aorta

O
O

O
O

Transient Ischemic Attack

O

O

PROCEDURE HISTORY12905

 If Yes, Location
mm/dd/yyyy

 If Yes, Severity13904: O Mild O Moderate O Severe
□ Severity Not Documented14459

If Yes, MI Timeframe13174:

O <30 days O >=30 days

 If Yes, CRT-D14259: O No

O Yes

14268

OCCURRENCE

NO

YES

Aortic Valve Procedure

O

O

Aortic Valve Repair Surgery

O

O

Aortic Valve Replacement Surgery

O

O

Aortic Valve Replacement - Transcatheter

O

O

Coronary Artery Bypass Graft

O

O

Implantable Cardioverter Defibrillator

O

O

Mitral Valve Procedure

O

O

Mitral Valve Annuloplasty Ring Surgery

O

O

Mitral Valve Repair Surgery

O

O

Mitral Valve Replacement Surgery

O

O

DATE14252
mm/dd/yyyy

mm/dd/yyyy

mm/dd/yyyy

 If Yes, MV Ring Type

14257

:

O Partial
O Circumferential
□ Not Documented14258

 If Yes, Type14261:
O Leaflet Clip O Direct Annuloplasty Intervention
O Coronary Sinus Based Intervention
O Valve-in-Native Valve O Valve-in-Valve O Other

Mitral Valve Transcathter Intervention

O

O

PCI

O

O

mm/dd/yyyy

Permanent Pacemaker

O
O

mm/dd/yyyy

Pulmonic Valve Procedure

O
O

Tricuspid Valve Procedure

O

O

mm/dd/yyyy

© 2021 STS and ACCF

O Treated O Active

26-Jan-2021

 If Yes, CRT14260

O No

O Yes

Page 3 of 12

STS/ACC TVT REGISTRY V3.0
TRANSCATHETER MITRAL VALVE REPAIR MITRAL LEAFLET CLIP PROCEDURE (TMVr)
D. LAB VISIT (COMPLETE FOR EACH LAB VISIT)
Procedures

:

□ TAVR

□ TMVr

□ TMVR

If Mitral Repair, Mitral Leaflet Clip

O No O Yes
: mm / dd / yyyy HH:MM

Procedure Room Entry Date/Time

PRESENTATION AND EVALUATION
O No Symptoms, No Angina
CAD Presentation12177:
O Unstable Angina
Heart Failure (w/in 2 weeks)14266:
NYHA Class (w/in 2 weeks)

12163

:

OI

O II

Cardiogenic Shock (w/in 24 hrs)13175:
Cardiac Arrest (w/in 24 hrs)

14267

:

O No

O Yes

O III

O IV

O No

O Yes

O No

O Yes

mm / dd / yyyy HH:MM

:

Procedure Room Exit Date/Time

:

mm / dd / yyyy HH:MM

O Symptoms Unlikely to be Ischemic

O Stable Angina

O Non-STEMI

O STEMI

STS Risk Score Measurement14271:
_______ %

STS Risk Score Type
MV Repair:

_______ %

MV Replace:

O No
:
KCCQ-12 Performed
If Yes, KCCQ-12
: (see separate questionnaire)
Q5:

Procedure Start Date/Time

mm / dd / yyyy HH:MM

:

Procedure End Date/Time

□ Tricuspid Valve Procedure

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

_______ Q6: _______ Q7:

Six Minute Walk Test

O No

:

:

_______ ft

:

If Yes, Total Distance
If No, Reason

O Yes

mm / dd / yyyy

:

If Yes, Test Date

KCCQ Summary
: (calculated)
Score

_______ Q8a:_______ Q8b:_______ Q8c:_______

O Non-Cardiac Reason

O Cardiac Reason O Patient Not Willing to Walk

O Not Performed By Site

PRE-PROCEDURE CLINICAL DATA (CLOSEST TO THE PROCEDURE)
Hemoglobin
Sodium
Creatinine

:

:
:

_______ g/dL

□ Not Drawn

BNP

_______ mEq/L

□ Not Drawn

NT proBNP

_______ mg/dL

□ Not Drawn

:
:

(or)

_______ pg/mL

□ Not Performed

_______ pg/mL

□ Not Performed

PRE-PROCEDURE ECG AND PULMONARY FUNCTION (CLOSEST TO THE PROCEDURE)
QRS Duration5055:

_______ msec

□ Ventricular Paced5045

FEV1 Predicted13216:

_______ %

□ Not Performed13217

DLCO (Predicted)13218: _______ %

□ Not Performed13219

PRE-PROCEDURE MEDICATIONS (24 HOURS PRIOR TO THE PROCEDURE)
:

Positive Inotropes

O No

O Yes

PRE-PROCEDURE DIAGNOSTIC CATH FINDINGS
:

Diagnostic Cath Performed

Proximal LAD >=70%
Cardiac Output

:

:

O Yes

□ Not Documented

O No

O Yes

□ Not Documented

________ L/min

□ Not Documented

________ mm Hg

□ Not Documented

________ mm Hg

□ Not Documented

________ mm Hg

□ Not Documented

________ mm Hg

□ Not Documented

:

Pulmonary Artery Pressure (mean)
Pulmonary Artery Pressure (systolic)
Right Atrial Pressure (mean)

 If Yes, Diagnostic Cath Date

O No

:

Pulmonary Capillary Wedge Pressure

© 2021 STS and ACCF

O Yes

:

mm / dd / yyyy

: O None O One O Two O Three □ Not Documented

Number of Diseased Vessels
Left Main Stenosis >=50%

O No

:

:
:

26-Jan-2021

Page 4 of 12

STS/ACC TVT REGISTRY V3.0
TRANSCATHETER MITRAL VALVE REPAIR MITRAL LEAFLET CLIP PROCEDURE (TMVr)
PRE-PROCEDURE ECHOCARDIOGRAM FINDINGS
LVEF13305: ________ %

LVEF Not Assessed13306

Left Ventricular Internal Systolic Dimension13721: ________ cm

□ Not Measured

Left Ventricular Internal Diastolic Dimension13723: ________ cm

□ Not Measured13724

Left Ventricular End Systolic Volume13725:

________ mL

□ Not Measured13727

Left Ventricular End Diastolic Volume13726:

________ mL

□ Not Measured13728

Left Atrial Volume13729: ______mL □ Not Measured13730
Aortic Regurgitation 13477: (highest) O None
Aortic Stenosis13307:
Mitral Valve Disease

O No
13704

:

O Trace/Trivial

O No

O None

If Yes, Effective Regurgitant Orifice Area (EROA)
If Yes, Mitral Stenosis13308:

O No

O Severe

Mitral Valve Disease Etiology

If Functional, Functional Type

13740

13743

:

Type13748:

O 3D Planimetry
O PISA
O Quantitative Dopplar O Other

O Functional MR (Secondary)

O Degenerative MR (Primary)

O Post Inflammatory

O Endocarditis

O None

O Other

:O None

O Anterior

O Posterior

O Bileaflet

□ Not Documented13745

O None

O Anterior

O Posterior

O Bileaflet

□ Not Documented13746

O Collagen Vascular Disease

O Drug Induced

O Idiopathic

O Prior Radiation Therapy

O Rheumatic Fever

□ Not Documented13753

O Anterior

Mitral Valve Annular Calcification13749: O Yes
Mitral Leaflet Calcification13751:

If EROA, Method
of Assessment13738:

:________ cm

O Severe

O Ischemic Chronic O Non-Ischemic Dilated Cardiomyopathy
: O Ischemic Acute, Post Infarction
O Restrictive Cardiomyopathy
O Hypertrophic Cardiomyopathy
O Pure Annular Dilation (w/Normal LV Systolic Fx)
□ Not Documented 13741
13742

Leaflet Tethering13744: O None

O Moderate O Moderate-Severe

________ mm Hg

(Check all that apply):




O Mild

2

________ cm2

: (smallest)

13490

O Trace/Trivial

O Yes

If Yes, MV Mean Gradient13317: (highest)



O Moderate

O Yes

13737

If Yes, MV Area

O Mild

O Yes

If Yes, Mitral Regurgitation13672: (highest)

13316

LA Volume Index13731: ______mL/m2 □ Not Measured13732

(OR)

O Yes

O Posterior
O No

□ Not Documented13747

□ Not Documented13750
□ Not Documented13752

O No

Tricuspid Regurgitation13318: (highest) O None

O Bileaflet

O Trace/Trivial

O Mild

O Moderate

O Severe

PROCEDURE INFORMATION
Concomitant Procedures Performed7065:
If Yes, Procedure Type(s)

7066

O Elective

Last Name, First Name, MI, NPI
Last Name, First Name, MI, NPI
_______________________,
_______________________

O Urgent

Procedure Location12871: O Cardiac CathLab
Anesthesia Type

13331

O Emergency

O Salvage

O Hybrid CathLab Suite

OHybrid OR Suite

O Other

: O General Anesthesia O Deep sedation/Analgesia O Moderate Sedation/Analgesia O Minimal Sedation/Anxiolysis

Procedure Aborted13505:
If Yes, Reason

O Yes

: (select the best option(s)): __________________, ___________________, __________________

Operator Name/NPI14476, 14477, 14478, 14479 :
Procedure Status7025:

O No

13506

O No

O Yes

O Consent Issue
O Device Delivery System Malfunction
: O Access Related
O Navigation Issue After Successful Access
O New Clinical Findings
O Patient Clinical Status
O System Issue
O Transseptal Access Related
O Other

If Yes, Action13757: O Conversion to Open Heart Surgery O Scheduled Open Heart Surgery O Rescheduled Transcatheter Procedure
O Converted to Clinical Trial
O Balloon Valvuloplasty
O Converted to Medical Therapy
O Other

© 2021 STS and ACCF

26-Jan-2021

Page 5 of 12

STS/ACC TVT REGISTRY V3.0
TRANSCATHETER MITRAL VALVE REPAIR – MITRAL LEAFLET CLIP PROCEDURE (TMVr)
PROCEDURE INFORMATION (CONT.)
Conversion to Open Heart Surgery 13542:
13543

If Yes, Reason

O No

O Access Related
O Valve Injury

:

Mechanical Support7422: O No

O Cardiac Tamponade
O Other

O Inability to Position Device

O Device Embolization

O Yes If Yes, Device7423:

____________
O
In place at start of procedure O Inserted during procedure and prior to
If Yes, Timing7424: intervention O Inserted after intervention has begun O Post Procedure

CardioPulmonary Bypass Used13579: O No
If Yes, Status13580:

O Yes

O Elective

O Yes
If Yes, CPB Time13581: _______ min

O Emergency

PROCEDURE MEDICATIONS (DURING THE PROCEDURE)
Positive Inotropes13644 O No

O Yes

RADIATION AND CONTRAST
C ODE ALL

Dose Area Product 14278:

AVAILABLE
MEASUREMENTS

Cumulative Air Kerma7210: ______ O mGy

______ O Gy · cm2

O dGy · cm2

O cGy · cm2

O mGy · cm2

O µGy · M2

O Gy Fluoro Time7214: ______ min Contrast Volume7215: ________ mL

POST IMPLANT MITRAL VALVE DATA
MV Gradient (mean)13762 (post implant): ________ mm Hg
Mitral Regurgitation14274 (post implant):

O None

O Trace/Trivial

O Mild

O Moderate

O Severe

TMVr PROCEDURE INFORMATION - INDICATIONS FOR MITRAL LEAFLET CLIP PROCEDURE
Mitral Leaflet Clip Procedure Indication (Check all that apply)13792:
Refractory to Guideline Determined Optimal Medical Therapy

Frailty (assessed by in-person cardiac surgeon consultation)

Hostile Chest

Severe Pulmonary Hypertension

Severe Liver Disease (Cirrhosis or MELD score >12)

Porcelain Aorta (or extensively calcified ascending aorta)

Predicted STS MV Repair Operative Mortality Risk of >=6% (for patients deemed likely to undergo MV repair)
Predicted STS MV Replacement Operative Mort Risk >=8% (for patients deemed likely to undergo MV replacement)
Right Ventricular Dysfunction w/Severe Tricuspid Regurg

Major Bleeding Diathesis

AIDS

Severe Dementia

Immobility

High Risk of Aspiration

Chemotherapy for Malignancy
□ Other

IMA at High Risk of Injury

TMVr PROCEDURE INFORMATION
Guiding Cath Access Site

13794

: O Right Femoral Vein
13795

Steerable Guide Cath Device ID

O Left Femoral Vein

DEVICE 113533

If Procedure Aborted is No, TMVr DEVICES

Refer to Device List

Location13800:

O A1P1
13799

Device Implanted Successfully

:

O Other Vein

Steerable Guide Cath Serial Number13796: _____________

: _________________

Device ID 13797:

O Jugular Vein

O A2P2

DEVICE 213533
Refer to Device List

O A3P3

O Other O A1P1

OA2P2

O A3P3

O No

O Yes

O No

O Yes

O No

O Yes

O No

O Yes

O Other

If Yes, Device Serial #13798:
If Yes, UDI14574:
If Yes, Deployed Then Removed13802:
If No, Reason13801:

© 2021 STS and ACCF

O Adverse Event
O Device Malfunction
O Inability to Grasp Leaflets
O Inability to Reduce MR
O MV Injury
O Mitral Stenosis
O Other
26-Jan-2021

O Adverse Event
O Device Malfunction
O Inability to Grasp Leaflets
O Inability to Reduce MR
O MV Injury
O Mitral Stenosis
O Other
Page 6 of 12

STS/ACC TVT REGISTRY V3.0
TRANSCATHETER MITRAL VALVE REPAIR MITRAL LEAFLET CLIP PROCEDURE (TMVr)
POST-PROCEDURE - INTRA OR POST-PROCEDURE EVENTS (COMPLETE FOR EACH PROCEDURE TYPE AND EVERY OCCURRENCE)
INTRA OR POST PROCEDURE EVENT(S)12153

EVENT(S) OCCURRED9002

 IF YES, EVENT DATE(S)14275

ASD Defect Closure due to Transseptal
Catheterization

O No

O Yes

mm / dd / yyyy

Atrial Fibrillation

O No

O Yes

mm / dd / yyyy

Bleeding – Access Site

O No

O Yes

mm / dd / yyyy

Bleeding – Gastrointestinal

O No

O Yes

mm / dd / yyyy

Bleeding – Genitourinary

O No

O Yes

mm / dd / yyyy

Bleeding – Other

O No

O Yes

mm / dd / yyyy

Bleeding - Hematoma at Access Site

O No

O Yes

mm / dd / yyyy

Bleeding – Retroperitoneal

O No

O Yes

mm / dd / yyyy

Cardiac Arrest

O No

O Yes

mm / dd / yyyy

Cardiac Perforation

O No

O Yes

mm / dd / yyyy

Cardiac Surgery or Intervention – Other Unplanned

O No

O Yes

mm / dd / yyyy

Complete Leaflet Clip Detachment

O No

O Yes

mm / dd / yyyy

Delivery System Component Embolization

O No

O Yes

mm / dd / yyyy

Device Embolization

O No

O Yes

mm / dd / yyyy

Device Thrombosis

O No

O Yes

mm / dd / yyyy

Device Related Event – Other

O No

O Yes

mm / dd / yyyy

Dialysis (New Requirement)

O No

O Yes

mm / dd / yyyy

Endocarditis

O No

O Yes

mm / dd / yyyy

Mitral Leaflet or Subvalvular Injury

O No

O Yes

mm / dd / yyyy

Myocardial Infarction

O No

O Yes

mm / dd / yyyy

Permanent Pacemaker

O No

O Yes

mm / dd / yyyy

Reintervention – Mitral Valve

O No

O Yes

mm / dd / yyyy

Single Leaflet Device Attachment

O No

O Yes

mm / dd / yyyy

Stroke – Ischemic

O No

O Yes

mm / dd / yyyy

Stroke – Hemorrhagic

O No

O Yes

mm / dd / yyyy

Stroke – Undetermined

O No

O Yes

mm / dd / yyyy

Transient Ischemic Attack (TIA)

O No

O Yes

mm / dd / yyyy

Transseptal Complication

O No

O Yes

mm / dd / yyyy

Vascular Complication – Major

O No

O Yes

mm / dd / yyyy

Vascular Complication – Minor

O No

O Yes

mm / dd / yyyy

Vascular Surgery or Intervention – Unplanned

O No

O Yes

mm / dd / yyyy

© 2021 STS and ACCF

26-Jan-2021

Page 7 of 12

STS/ACC TVT REGISTRY V3.0
TRANSCATHETER MITRAL VALVE REPAIR MITRAL LEAFLET CLIP PROCEDURE (TMVr)
IN-HOSPITAL ADJUDICATION (COMPLETE FOR EACH ISCHEMIC, HEMORRHAGIC, UNDETERMINED STROKE, TIA OR MV RE-INTERVENTION)
Event Date14313:

Adjudication Event14312:

O Hemorrhagic Stroke(In-hospital)
O Ischemic Stroke(In-hospital)
O Mitral Valve Re-intervention (In-hospital)
Status14314:

O Alive

mm / dd / yyyy

O Undetermined Stroke(In-hospital)

O TIA(In-hospital)

If Deceased, Date of Death:14315: mm / dd / yyyy

O Deceased

Clinical Comments 14462:

IF EVENT14312 = STROKE OR TIA (IN-HOSPITAL)
Symptom Onset Date14316:

mm / dd / yyyy

Neurologic Deficit with Rapid Onset14317:

O No

If Yes, Clinical Presentation14318:

O Stroke/TIA
14319

If Stroke/TIA, Symptom Duration > 24 hours

:

If Yes, Brain Imaging Type

:

O CT

If Yes, Brain Imaging Findings14350:

O Yes

O No

O Yes

O CT w/Contrast

O MRI

If Stroke/TIA, Event Related Sequelae

O Infarct

14351

O Non-Stroke

O No

If Stroke/TIA, Brain Imaging Performed14320:
14349

O Yes

O Hemorrhage

(Select all that apply) :

□ Altered Consciousness
□ Loss of Sensory Function

O MRI w/Contrast

O Other (e.g. angiography)

O No Deficit

□ Death
□ Permanent Vegetative State
□ Blindness □ Aphasia
□ Loss of Motor Function
□ Facial Paralysis □ Prolonged Length of Stay □ Other

If Status=Alive, Discharge Location14352: O Home O Skilled Nursing Facility O Extended Care/TCU/Rehab O Other Discharge Location
If Status=Alive, Patient Discharged to Prior Place of Living14421: O No

O Yes

If Status=Deceased, Stroke Diagnosed During Autopsy14353:

O Yes

O No

O Info Not Available

IF EVENT14312 = MITRAL VALVE RE-INTERVENTION (IN-HOSPITAL)
Mitral Valve Re-intervention Type

14360

MV Re-intervention Indication14361:

© 2021 STS and ACCF

:

O Surgical Replacement O Surgical Repair
O Balloon Valvuloplasty O Leaflet Clip Procedure
O Other Transcatheter Intervention

O Transcatheter Replacement
O Paravalvular Leak Closure

O Regurgitation
O Endocarditis

O Device Embolization
O Valve Injury

O Stenosis
O Device Thrombosis

26-Jan-2021

O Other

Page 8 of 12

STS/ACC TVT REGISTRY V3.0
TRANSCATHETER MITRAL VALVE REPAIR – MITRAL LEAFLET CLIP PROCEDURE (TMVr)
POST-PROCEDURE LABS AND ECG (COMPLETE FOR EACH PROCEDURE TYPE)
Hemoglobin (lowest)

□

:___________ (g/dL)
O No

12-Lead ECG Performed

Not Drawn14243

Creatinine (highest)

_________ (mg/dL)

□

Not Drawn

O Yes
: □ No Significant Changes

If Yes, 12-Lead ECG Findings

(Check all that apply)

□ Pathological Q Wave □ New LBBB □ Cardiac Arrhythmia

POST-PROCEDURE ECHOCARDIOGRAM (COMPLETE FOR EACH PROCEDURE)
O Yes – TTE

Echocardiogram

□ Not Performed

O Yes - TEE

If Yes, Mitral Regurgitation (highest)

O None

O Trace/Trivial

If Yes, MV Mean Gradient

O Mild

2

________ mm Hg

(highest)

O Moderate O Moderate-Severe
If EROA, Method
of Assessment

________ cm

If Yes, Effective Regurgitant Orifice Area (EROA)

mm / dd / yyyy

If Yes, Date

O Severe

O 3D Planimetry
O PISA
O Quantitative Dopplar O Other

E. DISCHARGE
Discharge Date10100:

mm / dd / yyyy

Discharge Provider Name, NPI10070,10072,10071,10073:
O Alive

Discharge Status

Last Name, First Name, MI, NPI

O Deceased

 If Alive, Cardiac Rehabilitation Referral

O No - Reason Not Documented O No - Medical Reason Documented
O No - Health Care System Reason Documented O No - Patient-Oriented Reason O Yes

O Home
O Skilled Nursing Facility
O Other Acute Care Hospital O Left Against Medical Advice (AMA)

 If Alive, Discharge Location

O No

 If Alive, Hospice Care

O Extended Care/TCU/Rehab
O Other Discharge Location

O Yes
O No

 If Deceased, Death During Procedure

O Yes

 If Deceased, Cause of Death
O Acute myocardial infarction
O Sudden cardiac death
O Heart failure
O Stroke
O Cardiovascular procedure
O Cardiovascular hemorrhage
O Other cardiovascular reason
PRBCs Transfused

:

O No

If Yes, PRBCs Units Transfused

O Pulmonary
O Renal
O Gastrointestinal
O Hepatobiliary
O Pancreatic
O Infection
O Inflammatory/Immunologic
O Yes

O Hemorrhage
O Non-cardiovascular procedure or surgery
O Trauma
O Suicide
O Neurological
O Malignancy
O Other non-cardiovascular reason

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

________

DISCHARGE MEDICATIONS D/c meds are not required for patients who expired, discharged to “Other Acute Care Hospital,” “AMA”, or are receiving Hospice Care.
PRESCRIBED10205
CATEGORY

MEDICATION CODE10200
YES

ACE Inhibitors (Angiotensin
Converting Enzyme)
Aldosterone Antagonist
Anticoagulant
Antiplatelet
ARB (Angiotensin Receptors Blockers)
Beta Blockers
Diuretics
Non-Vitamin K Dependent Oral
Anticoagulant
P2Y12 Inhibitors
© 2021 STS and ACCF

NO–
NO–
NO–
NO REASON MEDICAL REASON PT REASON

Angiotensin Converting Enzyme
Inhibitor
Aldosterone Antagonist
Direct Thrombin Inhibitor
Warfarin

O

O

O

O

O

O

O

O

O
O

O
O

O
O

O
O

Aspirin
Angiotensin II Receptor Blocker

O

O

O

O

Beta Blocker
Diuretics Not Otherwise Specified

O
O
O

O
O
O

O
O
O

O
O
O

Loop Diuretics
Thiazides

O
O

O
O

O
O

O
O

Direct Factor Xa Inhibitor

O

O

O

O

P2Y12 Antagonist

O

O

O

O

26-Jan-2021

 If Yes,
LOOP DIURETIC
DOSE14576

_____ mg

Page 9 of 12

STS/ACC TVT REGISTRY V3.0
TRANSCATHETER MITRAL VALVE REPAIR MITRAL LEAFLET CLIP PROCEDURE (TMVr)
F. FOLLOW-UP Follow-up should be performed at the following intervals post-procedure: 30 days (- 7 days/+ 75), 1 year (+/- 60 days)
Follow-up Assessment Date11000: mm / dd / yyyy
Reference Episode Arrival Date/Time11002:

mm / dd / yyyy HH:MM

Reference Episode Discharge Date14338:

mm / dd / yyyy

11001

Reference Procedure Start Date/Time
Reference Procedure Type13705:

:

mm / dd / yyyy HH:MM

O TAVR

11003

Method(s) to Determine Status

O TMVr

□ Office Visit
□ Phone Call
□ Obituary List

:

O TMVR

O Tricuspid Valve Procedure

□ Medical Records
□ Letter from Medical Provider
□ Social Security Death Master File □ Hospitalized
□ CMS Linked Data
□ Other

Follow-up Status11004: O Alive
O Lost to Follow-up
O Deceased
 If Alive, Residence 13805: O Home with No Health Aid O Home with Health Aid
 If Deceased, Date of Death11006:

O Long Term Care

O Other

□ Not Documented14511

mm / dd / yyyy

 If Deceased, O Acute myocardial infarction
O Sudden cardiac death
Cause of
O Heart failure
Death11007:
O Stroke
O Cardiovascular procedure
O Cardiovascular hemorrhage
O Other cardiovascular reason

O Pulmonary
O Renal
O Gastrointestinal
O Hepatobiliary
O Pancreatic
O Infection
O Inflammatory/Immunologic

O Hemorrhage
O Non-cardiovascular procedure or surgery
O Trauma
O Suicide
O Neurological
O Malignancy
O Other non-cardiovascular reason

FOLLOW-UP CLINICAL ASSESSMENT
Hemoglobin13775:

NYHA Classification

13688

OI

:

Creatinine13310:

□ Not Drawn14326

_____ g/dL

O II

12-Lead ECG Performed13689: O No

O III

_______ mg/dL

□ Not Drawn13311

□ Not Documented14333

O IV

O Yes

If Yes, 12-Lead ECG Findings 13621(Check all that apply): □ No Significant Changes

□ Pathological Q Wave □ New LBBB □ Cardiac Arrhythmia

FOLLOW-UP IMAGING – ECHOCARDIOGRAM
Echocardiogram13492:
13690

If Yes, LVEF

O Yes - TEE

O Yes - TTE

:

If Yes, Mitral Regurgitation
If Yes, MV Mean Gradient

13778

If Yes, Date13593

mm / dd / yyyy

13691

□ LVEF Not Assessed

________ %
13673

□ Not Performed14512

:

O None

O Trace/Trivial

O Mild

O Moderate

O Moderate-Severe O Severe

________ mm Hg

: (highest)

If Yes, Effective Regurtitant Orifice Area (EROA)

13768

If EROA, Method
of Assessment13780:

: ________ cm2

If Yes, Left Ventricular Internal Systolic Dimension13783: ________ cm

□ Not Measured14536

If Yes, Left Ventricular Internal Diastolic Dimension13784: ________ cm

□ Not Measured14537

If Yes, Left Ventricular End Systolic Volume13786:

________ mL

□ Not Measured14539

If Yes, Left Ventricular End Diastolic Volume13785:

________ mL

□ Not Measured14538

O 3D Planimetry
O PISA
O Quantitative Dopplar O Other

If Yes, Left Atrial Volume13787: _______ mL □ Not Measured14540 (OR) LA Volume Index13788: _______ mL/m2 □ Not Measured14582
FOLLOW-UP SIX MINUTE WALK TEST AND KCCQ
Six Minute Walk Test13789: O No
If Yes, Test Date13790:
If No, Reason

14263

O Yes

mm / dd / yyyy

If Yes, Total Distance14325:

: O Non-Cardiac Reason O Cardiac Reason O Patient Not Willing to Walk O Not Performed by Site

KCCQ-12 Performed13845:

O No

O Yes

If Yes, KCCQ-12 13847, 69, 50, 52, 54, 56, 58,

13844

If Yes, KCCQ-12 Date

:

mm / dd / yyyy

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

(see separate questionnaire)

Q5:

_______ Q6: _______ Q7:

© 2021 STS and ACCF

________ ft

_______ Q8a:_______ Q8b:_______ Q8c:_______
26-Jan-2021

KCCQ Summary
Score14535: (calculated)
Page 10 of 12

STS/ACC TVT REGISTRY V3.0
TRANSCATHETER MITRAL VALVE REPAIR MITRAL LEAFLET CLIP PROCEDURE (TMVr)
FOLLOW-UP MEDICATIONS
PRESCRIBED13696
CATEGORY

MEDICATION CODE11990

ACE Inhibitors (Angiotensin
Converting Enzyme)
Aldosterone Antagonist

Angiotensin Converting Enzyme
Inhibitor
Aldosterone Antagonist
Direct Thrombin Inhibitor
Warfarin

O

O

O

O

O

O

O

O

O
O

O
O

O
O

O
O

Aspirin
Angiotensin II Receptor Blocker
Beta Blocker

O

O

O

O

Diuretics Not Otherwise Specified

O
O
O

O
O
O

O
O
O

O
O
O

Loop Diuretics
Thiazides

O
O

O
O

O
O

O
O

Direct Factor Xa Inhibitor

O
O

O
O

O
O

O
O

Anticoagulant
Antiplatelet
ARB (Angiotensin Receptors Blockers)
Beta Blockers
Diuretics
Non-Vitamin K Dependent Oral
Anticoagulant
P2Y12 Inhibitor
FOLLOW-UP EVENTS

YES

P2Y12 Antagonist

SPECIFY THE EVENTS (AND EVENT DATES) THAT OCCURRED
12933

EVENT(S)

BETWEEN DISCHARGE AND

NO–
NO–
NO–
NO REASON MEDICAL REASON PT REASON

 If Yes,
LOOP DIURETIC
DOSE14577

_____ mg

30 DAY (FIRST) FOLLOW-UP (FU), OR BETWEEN FU ASSESSMENT DATE #1 AND #2.

EVENT(S) OCCURRED14276

 IF YES, EVENT DATE(S)14277

ASD Defect Closure due to Transseptal Catheterization

O No

O Yes

mm / dd / yyyy

Atrial Fibrillation

O No

O Yes

mm / dd / yyyy

Bleeding – Life Threatening

O No

O Yes

mm / dd / yyyy

Bleeding – Major

O No

O Yes

mm / dd / yyyy

Cardiac Surgery or Intervention – Other Unplanned

O No

O Yes

mm / dd / yyyy

Device Embolization

O No

O Yes

mm / dd / yyyy

Device Thrombosis

O No

O Yes

mm / dd / yyyy

Device Related Event – Other

O No

O Yes

mm / dd / yyyy

Dialysis (New Requirement)

O No

O Yes

mm / dd / yyyy

Endocarditis

O No

O Yes

mm / dd / yyyy

Myocardial Infarction

O No

O Yes

mm / dd / yyyy

Permanent Pacemaker

O No

O Yes

mm / dd / yyyy

Readmission – Cardiac (Not Heart Failure)

O No

O Yes

mm / dd / yyyy

Readmission – Heart Failure (Complete Adjudication)

O No

O Yes

mm / dd / yyyy

Readmission – Non-Cardiac

O No

O Yes

mm / dd / yyyy

Reintervention – Mitral Valve (Complete Adjudication)

O No

O Yes

mm / dd / yyyy

Single Leaflet Device Attachment

O No

O Yes

mm / dd / yyyy

Stroke – Ischemic

O No

O Yes

mm / dd / yyyy

Stroke – Hemorrhagic

O No

O Yes

mm / dd / yyyy

Stroke – Undetermined

O No

O Yes

mm / dd / yyyy

Transient Ischemic Attack (TIA)

O No

O Yes

mm / dd / yyyy

Vascular Complication – Major

O No

O Yes

mm / dd / yyyy

Vascular Complication – Minor

O No

O Yes

mm / dd / yyyy

Vascular Surgery or Intervention – Unplanned

O No

O Yes

mm / dd / yyyy

© 2021 STS and ACCF

26-Jan-2021

Page 11 of 12

STS/ACC TVT REGISTRY V3.0
TRANSCATHETER MITRAL VALVE REPAIR MITRAL LEAFLET CLIP PROCEDURE (TMVr)
FOLLOW-UP ADJUDICATION (COMPLETE FOR EACH ISCHEMIC, HEMORRHAGIC, UNDETERMINED STROKE, TIA, MV RE-INTERVENTION OR HF READMISSION)
Event Date14386:

Adjudication Event14385:

mm / dd / yyyy

O Ischemic Stroke (follow-up) O Hemorrhagic Stroke (follow-up) O Undetermened Stroke (follow-up)
O Mitral Valve Re-intervention (follow-up) O Heart Failure Readmission (follow-up)
Status14387:

O Alive

O TIA (follow-up)

If Deceased, Date of Death:14388: mm / dd / yyyy

O Deceased

Clinical Comments 14463:

IF EVENT14385 = STROKE OR TIA (FOLLOW-UP)
Symptom Onset Date14389:

mm / dd / yyyy

Neurologic Deficit with Rapid Onset14390:

O No

If Yes, Clinical Presentation14391:

O Stroke/TIA
14392

If Stroke/TIA, Symptom Duration > 24 hours

:

If Stroke/TIA, Brain Imaging Performed14393:
If Yes, Brain Imaging Type

14394

O CT

:

14396

O Non-Stroke

O No

O Yes

O No

O Yes

O CT w/Contrast

If Yes, Brain Imaging Findings14395: O Infarct
If Stroke/TIA, Event Related Sequelae

O Yes

O MRI

O Hemorrhage

(Select all that apply):

□ Altered Consciousness
□ Loss of Sensory Function

O MRI w/Contrast

O Other (e.g. angiography)

O No Deficit

□ Death
□ Permanent Vegetative State
□ Blindness □ Aphasia
□ Loss of Motor Function
□ Facial Paralysis □ Prolonged Length of Stay
□ Other

If Status=Alive, Discharge Location14420:O Home O Skilled Nursing Facility O Extended Care/TCU/Rehab O Other Discharge Location
If Status=Alive, Patient Discharged to Prior Place of Living14422: O No

O Yes

If Status=Deceased, Stroke Diagnosed During Autopsy14397:

O Yes

O No

O Info Not Available

IF EVENT14385 = MITRAL VALVE RE-INTERVENTION (FOLLOW-UP)
Mitral Valve Re-intervention Type

14405

:

MV Re-intervention Indication14406:

O Surgical Replacement O Surgical Repair
O Balloon Valvuloplasty O Leaflet Clip Procedure
O Other Transcatheter Intervention

O Transcatheter Replacement
O Paravalvular Leak Closure

O Regurgitation
O Endocarditis

O Device Embolization
O Valve Injury

O Stenosis
O Device Thrombosis

O Other

IF EVENT14385 = READMISSION (HEART FAILURE)
Hospitalization >=24 Hours14380:
14381

Clinical Signs and/or Symptoms of Heart Failure
IV or Invasive Treatment Required14382:

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; invasive treatment includes ultrafiltration, IABP or mechanical assistance.

© 2021 STS and ACCF

26-Jan-2021

Page 12 of 12