sts/acc tvt registry v2 - ncdr.com · sts/acc tvt registry tm v2.0 ... o leaflet clip o direct...

STS/ACC TVT RegistryTMv2.0

Transcatheter Mitral Valve-in-Valve or Valve-in-Ring Procedure

If Yes, MV Replacement – Surgical4100

:

Mitral Valve or Ring Model ID4116

:

If Yes, MV Type4105

: O Bioprosthetic stentedO Bioprosthetic stentless O Not Documented

© 2011 STS and ACCF 3/4/2015 4:52 PM of 9

If Yes, MV Replacement Model ID4106

: ___________________Refer to Device List

Last Name2000: First Name2010: Middle Name2020:

SSN2030: - - □ SSN N/A2031Patient ID2040: (auto) Other ID2045:

Birth Date2050

:

□ White2070 □ Black/African American2071 □ Asian2072

□ American Indian/Alaskan Native2073

□ Native Hawaiian/Pacific Islander2074

Race:

(check all that apply)

Sex2060: Hispanic or Latino Ethnicity2076: O No O YesO Male O Female

A. DEMOGRAPHICS

mm / dd / yyyy

Arrival Date/Time3000,3001:

B. EPISODE OF CARE

mm / dd / yyyy HH:MM

□ Private Health Insurance3005

□ Medicare3006

□ Medicaid3007

□ Military Health Care3008

□ State-Specific Plan (non-Medicaid)3009

□ Indian Health Service3010

□ Non-US Insurance3011

□ None3012

Insurance Payors:

(check all that apply)

Research Study3030

: If Yes, Study Patient ID3032

:HIC3015

: O No O Yes

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

Prior CABG4030

:

Permanent Pacemaker4010:

O No O Yes

O No O Yes

O No O Yes

Infective Endocarditis4000:

Prior Aortic Valve Procedure4060

: O No O Yes

Previous ICD4015: O No O Yes

Prior PCI4020

:

CARDIAC HISTORY

# Previous Cardiac Surgeries4055

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

If Yes, Most Recent MV Procedure Date4097

: mm / dd / yyyy

If Yes, MV Transcatheter Intervention4112

:

O Leaflet clip O Direct annuloplasty intervention

O Coronary sinus based intervention O Valve-in-native Valve

O Valve-in-Valve O Other

If Yes, Mitral Transcather Type4113

:

If Yes, MV Repair – Surgical4110

:

If Yes, Prior Tricuspid Valve

Repair/Replacement4118

:

If Yes, Mitral Annuloplasty Ring – Surgical4111

:

O No O Yes – partial

O Yes – circumferential O Not Documented

If Yes, Prior Pulmonic Valve

Repair/Replacement4119

:

If Yes, CRT4013

:

If Yes, CRT–D4016

:

O No O Yes

O No O Yes

Heart Failure Hospitalization w/in Past Year4006:

O No O Yes

O No O Yes

O No O Yes

If Yes, AV Replacement – Surgical4070

:

If Yes, AV Transcatheter Valve

Replacement4090

:

O No O YesIf Yes, AV Repair – Surgical4080

:

O No O Yes O Not Documented

Prior Non-Aortic Valve Procedure4095:

Residence3003

: O Home w/no health-aid O Home w/health-aid O Long-term care O Other O Not Documented

Prior Stroke4120

:

If Yes, Most Recent Stroke Date4125

: mm / dd / yyyy

O No O YesDiabetes Mellitus4165

:

If Yes, Diabetes Therapy4170

:

O None O Diet O Oral O Insulin O Other

OTHER HISTORY AND RISK FACTORS

Transient Ischemic Attack4130

:

If Yes, Infective Endocarditis Type4005: O Treated O Active

O No O Yes

O No O Yes

O No O Yes

O No O Yes

O No O Yes

O No O Yes

O No O Yes

O No O Yes

___________________Refer to Device List



OTHER HISTORY AND RISK FACTORS

© 2011 STS and ACCF 3/4/2015 4:52 PM of 9

Immunocompromise Present4185

:

Peripheral Arterial Disease4145

:

Hypertension4155

: O No O Yes

Current Smoker4150

(w/in 1 year):

Currently on Dialysis4175

:

Chronic Lung Disease4180

: O None O Mild O Moderate O Severe

Home Oxygen4181

: O No O Yes

Carotid Stenosis4135

: O None O Right O Left O Both O NA

If Yes, Prior CEA/CAS4140

:

Hostile Chest4182

: O No O Yes

O No O Yes

O No O Yes

O No O Yes

O No O Yes

O No O Yes

If Loop Diuretic, Dose4210

:_____mg

HOME MEDICATIONS

ACE or ARB (any)4200,4205

: Diuretics – Aldosterone Antagonists4200,4205

:

Diuretics – Loop diuretic4200,4205

:

Diuretics – Thiazides4200,4205

:

Diuretics (not otherwise specified)4200,4205

:

Anticoagulants (any)4200,4205

:

Aspirin (alone)4200,4205

:

Aspirin (dual antiplatelet therapy)4200,4205

:

Beta Blockers (any)4200,4205

:

O No O Yes O No O Yes


O No O Yes



D. PRE-PROCEDURE STATUS (COMPLETE FOR THE PROCEDURE)

Heart Failure w/in 2 Weeks5020

:

NYHA Class w/in 2 Weeks5025

:

Cardiogenic Shock w/in 24 Hours5030

:

Cardiac Arrest w/in 24 Hours5035

:

Atrial Fibrillation/Flutter5050: O No O Yes

O I O II O III O IV

_______ %

If Yes, AF Class w/in past 30 days5052: O None O Persistent O Paroxysmal

CAD Presentation5000

: O No Sxs, no angina (14 days) O Sx unlikely to be ischemic (14 days) O Stable angina (42 days)

O Unstable angina (60 days) O Non-STEMI (7 days) O STEMI (7 days)

Prior MI5005

: If Yes, Prior MI Timeframe5010

: O < 30 Days O >= 30 days

Cardiomyopathy5012

: O No O Yes – Ischemic O Yes – Non-ischemic

mm / dd / yyyy

Total Distance5117

: ___________ ft

Six Minute Walk Test5115

:

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

STS Risk Score (MV replace)5106

:

Test Date5116

:

(See separate questionnaire)

If Yes, KCCQ-125170-5181

:

KCCQ-12 Performed5169

: O No O Yes

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

Q5: _______ Q6: _______ Q7: _______ Q8a: _______ Q8b: _______ Q8c: _______

Porcelain Aorta5045:

O No O Yes

O No O Yes

O No O Yes

O No O Yes

O No O Yes

Height5200

: Weight5205

:

CLINICAL DATA (CLOSEST TO THE PROCEDURE)

___________ cm ___________ kg

Creatinine5255

:

Hemoglobin5250

:

□ Not Drawn5256

□ Not Drawn5251_______ g/dL

_______ mg/dL

FEV1 Predicted5280

:_______ %

DLCO (Adjusted)5285

: _______ %

□ Not Performed5281


BNP5277

: ______ pg/mL (OR) NT proBNP5278

: _____ pg/mL

□ Not Drawn5279

QRS Duration5290

: □ Ventricular Paced5291________ msec

MEDICATIONS (ADMINISTERED WITHIN 24 HOURS PRIOR TO THE PROCEDURE)

Inotropes5400,5405

(positive): O No O Yes O Contraindicated O Blinded

Left Ventricular Internal Systolic Dimension5595

:

Left Ventricular Internal Diastolic Dimension5600

:

______ cm

© 2011 STS and ACCF 3/4/2015 4:52 PM

Aortic Regurgitation5630

(highest):

Left Atrial Volume5606

: ____ ml (OR) LA Volume Index5607

: _____ mL/m2

Left Ventricular End Diastolic Volume5603

:

Left Ventricular End Systolic Volume5601

:

Aortic Stenosis5665

: O No O Yes

MV Area5710

: MV Mean Gradient5715

(highest): ________ cm2

________ mmHg

______ ml

______ ml



□ Not Measured5604


Effective Orifice Area (EOA) or EROA 5698

: ________ cm2

ECHOCARDIOGRAM FINDINGS

of 9

If Prior MV Replacement, Paravalvular Severity5696

: O None O Mild O Moderate O Severe O Not Documented

If Prior MV Replacement, Valvular Severity5697

:

If Prior Prosthetic MV, Prosthetic Mitral Valve Dysfunction Etiology5742

:

O Primary/degenerative bioprosthetic Valve Failure O Pannus formation O Thrombus formation O Other



Mitral Valve Disease5685

: O No O Yes If Yes, complete the following:

MV Valve Stenosis5705

: O No O Yes

Tricuspid Regurgitation5735

: O None O Trace/Trivial O Mild O Moderate O Severe

DIAGNOSTIC CATH FINDINGS

LVEF5565

: □ LVEF Not Assessed5566

Right Atrial Pressure/CVP (mean)5598

:

Pulmonary Capillary Wedge Pressure5590

:

_________ mmHg

_________ mmHg

________ %

Left Main Stenosis >=50%5507

:

Number of Diseased Vessels5506

: O None O 1 O 2 O 3

Pulmonary Artery Pressure (systolic)5596

:


Pulmonary Artery Pressure (mean)5593

:

Cardiac Output5567

:

_________ mmHg

_________ mmHg

_________ L/min





O No O Yes

______ cm

O None O Trace/Trivial O 1+ (mild) O 2+ (moderate) O 3-4+ (severe)

Mitral Regurgitation5695

(highest): O None O Trace/Trivial O 1+ (mild) O 2+ (moderate) O 3+ (moderate – severe) O 4+ (severe)

O None O Mild O Moderate O Severe O Not Documented

Method of Assessment5699

: O 3D Planimetry O PISAO Quantitative Doppler O Other

Mitral Valve Disease Etiology (check all that apply):

If DMR is Yes, Leaflet Prolapse5760:

If DMR is Yes, Leaflet Flail

5765:

If Inflammatory is Yes, Type

5770:

If FMR is Yes, Functional Type

5755:

□ Degenerative Mitral Regurgitation (DMR)5746

□ Endocarditis5748

□ Functional Mitral Regurgitation (FMR)5745 □ Post – Inflammatory5747

□ Other/Indeterminate5749

O None O Anterior O Posterior O Bi-leaflet O Not Documented

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 Idiopathic O Prior radiation Rx O Collagen vascular disease

O Drug induced O Rheumatic fever history O Not Documented

O None O Anterior O Posterior O Bi-leaflet O Not Documented

ECHOCARDIOGRAM FINDINGS CONT’D

Procedure Start Date/Time6040,6041

: Procedure Stop Date/Time6045,6046

:mm / dd / yyyy HH:MM mm / dd / yyyy HH:MM

Procedure Status6055

: O Elective O Urgent O Emergency O Salvage

© 2011 STS and ACCF 3/4/2015 4:52 PM

Type of Anesthesia6110

: O General anesthesia O Moderate sedation O Epidural O Combination

Procedure Access Site29180

: O Transseptal O Transapical O Direct left atrium O Femoral artery O Other

STS/ACC TVT RegistryTM

v2.0


of 9

Procedure Aborted29120

:

O Access related O Navigation issue after successful access

O New clinical findings O Device/delivery system malfunction

O Patient clinical status O Consent issue

O Transseptal access related O System issue

O Other (not specified)

O No O Yes

If Yes, Reason29125

:

Operator Reason for Procedure29115

: 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)

If Yes, Action29127

: O Balloon valvuloplasty O Rescheduled transcatheter procedure

O Conversion to open heart surgery O Converted to medical therapy

O Converted to clinical trial O Open heart surgery scheduled O Other

Mitral Leaflet Calcification5810

:

Leaflet Tethering5775

:

Mitral Annular Calcification5800

:

Procedures:

Conversion to Open Heart Surgery29130

: O No O Yes

If Yes, Reason29135

: O Access related problem/injury O Inability to position device O Valve injury

O Device embolization O Tamponade/bleeding in the heart O Other

Mechanical Assist Device29140

:

If Yes, Type29146:

CardioPulmonary Bypass Used6100

: O No O Yes If Yes, Status6101: O Elective O Emergent

O No O Yes

If Yes, CPB Time 6105:

If Yes, Timing29145:

Pre-Implant Balloon Inflation Performed29185

:

If Yes, Significant Hemodynamic Deterioration After Inflation29190:

O No O Yes

O No O Yes

Other Procedure Performed Concurrently6620

: O No O Yes – PCI O Yes – Other

□ Transcatheter Aortic Valve Replacement6600 □ Transcatheter Mitral Valve Replacement

6601 □ Mitral Leaflet Clip Procedure6602

O None O Anterior O Posterior O Bi-leaflet O Not documented

O Yes O No O Not documented

O Yes O No O Not documented

E. PROCEDURE INFORMATION (COMPLETE FOR EACH MITRAL VALVE-IN-VALVE OR VALVE-IN-RING PROCEDURE)

O Pre-procedure O Intraprocedure O Postprocedure

O IABP O Catheter-based assist device

______ mins

Operator A Name6000,6005,6010

: Operator A NPI6015

:

Operator B Name6020,6025,6030

: Operator B NPI6035

:

Additional Procedures

Bleed/Vascular

Neuro

Renal

Device

Cardiac

© 2011 STS and ACCF 3/4/2015 4:52 PM

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

Cardiac ArrestE005

:

Myocardial InfarctionE059:

EndocarditisE003

:

Perforation w/ or w/o TamponadeE009

:

Device ThrombosisE027

:

Other Device Related EventE028

:

Bleeding at Access SiteE017

:

Retroperitoneal BleedingE019

:

Hematoma at Access SiteE018

:

GI BleedE020

:

GU BleedE021

:

Other BleedE022

:

Transient Ischemic AttackE010

(complete Adjudication):

Ischemic StrokeE011


Atrial Fibrillation (new onset)E006

: mm / dd / yyyy

New Requirement for DialysisE029

:

mm / dd / yyyy

Hemorrhagic StrokeE012


mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

Stroke (Undetermined Type)E013


mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

Intra or Post Procedure Events Occurred7300

: O No O Yes If Yes, specify the Event7301

and Event Date(s)7302

:

mm / dd / yyyy

Major Vascular ComplicationE041

:

Transseptal Related EventE052

:

Minor Vascular ComplicationE042

:

Device EmbolizationE050

:

STS/ACC TVT RegistryTM

v2.0


Fluoroscopy Time6460

:

Dose Area Product6470

: O Gy-cm2O cGy-cm

2O mGy-cm

2O µGy-M

2

Radiation Dose Measurement Method6455

: O Single Plane O Biplane

_______ mGy

_______ DAP Units6475

:

Cumulative Air Kerma6465

:

_______ mins

MV Mean Gradient29290

(highest): ________ mmHg

of 9

Conduction/Native Pacer

Disturbance Req PacerE039

:


Disturbance Req ICDE040

:

LVOT ObstructionE044

:

Device MigrationE023

:

Device Recapture or RetrievalE026

: Transapical Related EventE014:

mm / dd / yyyy

ASD Closure

Due To Transseptal CatheterizationE054:

Mitral Valve Re-interventionE053


Unplanned Other Cardiac Surgery or InterventionE031

(not MVR):

Unplanned

Vascular Surgery or InterventionE032

(for Bleeding or Access Site Complication):

mm / dd / yyyy

POST IMPLANT

Device 1 Used29201

:

Device 2 Used29201

:

__________________________ Device Serial Number29205

:

PROSTHETIC VALVE/DEVICE INVENTORY

Refer to Device List

(future)UDI29210, 29215, 29220

:

Device Implanted Successfully29225

:

Contrast Volume29295

:

Post-Implant Balloon Inflation Performed29195: O No O Yes

__________________________Refer to Device List O No O Yes

__________________________


: 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

_______ ml

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy


:

Lowest Hemoglobin8040

: _______ g/dL ______ mg/dLHighest Creatinine8050

:

Echocardiogram8065

: O Not Performed O Yes - TTE O Yes - TEE If Yes, complete the following:

mm / dd / yyyy

Mean Mitral Gradient8130

(highest): ________ mmHg

G. POST-PROCEDURE LABS AND TESTS

□ Not Drawn8041 □ Not Drawn

8051

© 2011 STS and ACCF 3/4/2015 4:52 PM

Date8070

:

Effective Orifice Area (EOA) or EROA 8122

: ________ cm2

of 9

Systolic Anterior Motion Present8145

: O No O Yes

LVOT gradient (peak)8140

:

If Trace/Trivial, Mild, Moderate, or Severe, Paravalvular Severity8112


O Not Documented

If Trace/Trivial, Mild, Moderate, or Severe, Valvular Severity8115

:


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



Mitral Valve Area8135

:

12-Lead ECG Findings8060

: O Not performed O No significant changes O New pathological Q-wave or LBBB

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

O None O Mild O Moderate O Severe

O Not Documented

________ mmHg _______ cm2

Discharge Date9045

: Discharge Status9050

:

If Deceased, Death in Lab/OR9060:

O Alive O Deceased

O No O Yes

If Deceased, Primary Cause of Death9065: O Cardiac O Neurologic O Renal O Vascular O Infection

O Valvular O Pulmonary O Unknown O Other

mm / dd / yyyy

If Alive, Discharge Location9055: O Home O Extended care/TCU/rehab O Other acute care hospital

O Nursing home O Hospice O Other O Left against medical advice (AMA)

Number of Hours in ICU9040

:

O No O Yes If Yes, # Units Transfused9012

: ________RBC/Whole Blood Transfusion9011

:

H. DISCHARGE (COMPLETE FOR EACH EPISODE OF CARE)

________

Note: Code the total # of units between start

of the procedure and discharge

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

O No O Yes O Contraindicated O Blinded


ACE/ARB9100,9105

(any):





Aspirin (alone)9100,9105

:



Diuretics – Loop9100,9105

:


:

Diuretics – Aldosterone Antagonists9100,9105

:


:


:

Beta Blockers (any)9100,9105

:

If Loop Diuretic, Dose9110

:

Anticoagulants (any)9100,9105


_____mg

© 2011 STS and ACCF 3/4/2015 4:52 PM

STS/ACC TVT Registry™ v2.0Transcatheter Mitral Valve-in-Valve or Valve-in-Ring Procedure

of 9

Systolic Anterior Motion Present10375: O No O Yes

LVOT gradient (peak)10370

: ______mmHg

Last Name2000: First Name2010:

NYHA Classification at Follow-up10100

: O I O II O III O IV

Status10010

: O Alive O Deceased O Lost to follow-up O Withdrawn

Assessment Date10000:

Reference Procedure Start Date6040:

Patient ID2040:

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

mm / dd / yyyy

mm / dd / yyyy

Primary Method to Determine Status10005: O Clinic O Medical record O Letter from medical provider

O Phone call to patient/family O Social Security death master file O Other

If Deceased, Primary Cause of Death10015

:

If Deceased, Date of Death10020

: mm / dd / yyyy

_______ mg/dLHemoglobin10085

: _____ g/dL Creatinine10090

:

Other ID2045:

□ Not Drawn10091□ Not Drawn10086

LVEF10210

:

Echocardiogram10206

: O Not Performed O Yes - TTE O Yes - TEE If Yes, complete the following

□ LVEF Not Assessed10211

________ %

Study Patient ID3032

:

(See separate questionnaire)

If Yes, KCCQ-1210231-10243

:

(optional)

mm / dd / yyyy

KCCQ-12 Performed10230

: O No O Yes

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

Q5: _______ Q6: _______ Q7: _______ Q8a: _______ Q8b: _______ Q8c: _______

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

Residence10008

: O Home w/no health-aid O Home w/health-aid O Long-term care O Other O Not documented

Six Minute Walk Test Performed10380

:

Test Date10385

:

Total Distance Walked10390

: __________ ft

mm / dd / yyyy

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


:

Mean Mitral Gradient10330

: ________ mmHg

O None O Trace/Trivial O 1+ (mild) O 2+ (moderate) O 3+ (moderate – severe) O 4+ (severe)


:Effective Orifice Area (EOA) or EROA 10315

: ________ cm2

Left Ventricular Internal Systolic Dimension10345

:

Left Ventricular Internal Diastolic Dimension10350

:

________ cm

________ cm

Left Atrial Volume10335

: ____ mL (OR) LA Volume Index10340

: _____ mL/m2

Left Ventricular End Diastolic Volume10360

:

Left Ventricular End Systolic Volume10355

: ________ mL

________ mL

Tricuspid Regurgitation10365

: O None O Trace/Trivial O Mild O Moderate O Severe

Note: According to American Society of Echocardiography Guidelines

O 3D Planimetry O PISA O Quantitative Doppler O Other





Date10207

:

O Cardiac O Neurologic O Renal O Vascular O Infection

O Valvular O Pulmonary O Unknown O Other

If Trace/Trivial, Mild, Moderate, or Severe, Paravalvular Severity10305


O Not Documented

If Trace/Trivial, Mild, Moderate, or Severe, Valvular Severity10310: O None O Mild O Moderate O Severe

O Not Documented

Mitral Valve Area10325

: ________ cm2

Bleeding/Vascular

© 2011 STS and ACCF 3/4/2015 4:52 PM



of 9

Renal

Readmission

Additional Procedures

Device

Neuro

Cardiac

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

Myocardial InfarctionE059

:

Life Threatening BleedingE037

:

New Requirement for DialysisE029

:



EndocarditisE003

:


ADVERSE EVENTS, READMISSIONS, INTERVENTIONS AND SURGICAL PROCEDURES (SPECIFY THE EVENT DATE FOR EACH EVENT THAT OCCURRED

BETWEEN DISCHARGE AND 30-DAY F/U, OR BETWEEN F/U ASSESSMENT DATE #1 AND F/U ASSESSMENT DATE #2.)

Readmission – Cardiac (not HF)E056

:

Unplanned Other Cardiac Surgery or Intervention

E031(not Mitral):

Mitral Valve Re-interventionE053

(complete Adjudication): Ischemic StrokeE011


Hemorrhagic StrokeE012


Stroke (Undetermined Type) E013


O No O Yes If Yes, specify the Event10246

and Event Date(s)10247

:

Unplanned Vascular Surgery

or InterventionE032

(for Bleeding or Access Site Complication):

Transient Ischemic AttackE010


Major Vascular ComplicationE041

:

Readmission – Heart FailureE055


Minor Vascular ComplicationE042

:

Major Bleeding EventE043

:

Atrial Fibrillation (new onset)E006

:

ASD Closure

Due To Transeptal CatheterizationE054

:

Device Embolization E050

:

Other Device Related EventE028

:

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

ACE/ARB10250,10255

(any):

Diuretics – Loop10250,10255

:

Diuretics – Aldosterone Antagonists10250,10255

:

Beta Blockers10250,10255

(any):

If Loop Diuretic, Dose10257:

Readmission – Non-Cardiac

(Follow Up)E057

:

Follow-up Events Occurred10245

:




Aspirin10250,10255

(alone):


:


:


:

Anticoagulants10250,10255

(any):


_____ mg

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy

mm / dd / yyyy



Device FractureE038

:

Device MigrationE023

:

Device ThrombosisE027

: mm / dd / yyyy

Transapical Related EventE014

:

mm / dd / yyyy


Disturbance Req PacerE039

:


Disturbance Req ICDE040: mm / dd / yyyy

mm / dd / yyyy

© 2011 STS and ACCF 3/4/2015 4:52 PM

STS/ACC TVT Registry™ v2.0Transcatheter Mitral Valve-in-Valve or Valve-in-Ring Procedure

If Event12000

is Stroke or TIA

Neurologic Deficit with Rapid Onset12020

:

Date of Symptom Onset12015

(approximate):

If Stroke/TIA, Symptom Duration > 24 hours12030

:

If Yes, Clinical Presentation12025

:

If Stroke/TIA, Neuroimaging Performed12040

:

If Stroke/TIA, Death as a Result of Neurologic Deficit12060

:

If Stroke/TIA, Neurologist/Neurosurgeon Confirmation of Diagnosis12055

:

Clinical Comments12065

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

O No O Yes

mm / dd / yyyy

O Stroke/TIA O Non-Stroke

O No O Yes

O No O Yes

O No O Yes

O No O Yes

Mitral Valve Re-intervention Type12200

:

If Other Transcatheter Intervention, Other Type12205:

O Surgical MV Repair O Surgical MV Replacement O Transcatheter MV Repair

O Transcatheter MV Replacement O Leaflet Clip Procedure O Other Transcath Intervention

Clinical Comments12220

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

O Mitral regurgitation O Mitral stenosis O Mitral valve injury

O Device embolization O Endocarditis O Device thrombosis O Other

MV Reintervention Indication12210

:

If Other, Other Indication12215

: __________________________________________________________________________

______________________________________________________________

Adjudication Event12000

: O Ischemic Stroke(In-hospital) O Hemorrhagic Stroke(In-hospital) O Undetermined Stroke(In-hospital) O TIA(In-hospital)

O Mitral Valve Re-intervention(In-hospital)

O Ischemic Stroke(F-U) O Hemorrhagic Stroke(F-U) O Undetermined Stroke(F-U) O TIA(F-U)

O Mitral Valve Reintervention(F-U)

O Readmission – Heart Failure (F-U)

mm / dd / yyyy If Deceased, Date of Death12011

:Status12010

: O Alive O Deceased

Last Name2000

: First Name2010

:

Reference Procedure Start Date6040

: mm / dd / yyyy Other ID2045

:

Patient ID2040

:

Study Patient ID3032

:

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

Event Date12005

:

(optional)

If Event12000

is Mitral Valve Re-intervention

mm / dd / yyyy

If Stroke/TIA, Social/Recreational Activities Impaired12056

:

If Stroke/TIA, Neurocognitive Functions Essential to Pt or their Livelihood Impaired:12057

:

If Stroke/TIA, New Aids or Assistance Required:12058

:

O No O Yes

O No O Yes

O No O Yes

If Event12000

is Readmission (Heart Failure)

If Yes, Deficit Type12045

: O No deficit O Infarction O Hemorrhage O Both (hem/infarc) O Subarachnoid Hemorrhage

O No O Yes O Information not availableHospitalization >=24 hours12225

:

Clinical Signs and/or Symptoms of Heart Failure12230

:

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

IV or Invasive Treatment Required12335

:

O No O Yes O Information not available

O No O Yes O Information not available

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