PulseCath iVAC 2L Post-Market Surveillance Form

Operator *

First

Last

Layout

Hospital *

Country *

Email *

NYHA (Heart failure classification)IIIIIIIV

Date *

(dd/mm/yyyy)

Serial number: *

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Age *

Weight (Kg) *

Gender *MaleFemale

Height (cm) *

Indication *

• Acute coronary syndrome
• Emergent
• Stable angina
• Urgent
• Elective
• *Other, fill in below

*Other, please specify:

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SYNTAX score

EF (%) *

STS mort.

Antecedents

Mark if present *

• Diabetes II
• Periph. Artery Disease
• Venous thrombosis
• Hypertension
• Ischemic Stroke
• Myoc. Infarction
• Kidney Failure
• Hemorrhagic Stroke
• Previous PCI
• Smoking /COPD
• Atrial Fibrillation
• Previous CABG
• Dyslipidemia
• Ventricular Arrhythmias
• Surgery Refusal
• Chronic Anticoag.
• Hemodialysis
• Cancer
• None

Valve Disease

	REGURGITATION	STENOSIS
Valve	REGURGITATIONValve REGURGITATION	STENOSISValve STENOSIS
Aortic	REGURGITATIONAortic REGURGITATION	STENOSISAortic STENOSIS
Mitral	REGURGITATIONMitral REGURGITATION	STENOSISMitral STENOSIS
Tricuspid	REGURGITATIONTricuspid REGURGITATION	STENOSISTricuspid STENOSIS
Pulmonic	REGURGITATIONPulmonic REGURGITATION	STENOSISPulmonic STENOSIS

Severity

	MILD	MOD	SEVERE
Valve	MILDValve MILD	MODValve MOD	SEVEREValve SEVERE
Aortic	MILDAortic MILD	MODAortic MOD	SEVEREAortic SEVERE
Mitral	MILDMitral MILD	MODMitral MOD	SEVEREMitral SEVERE
Tricuspid	MILDTricuspid MILD	MODTricuspid MOD	SEVERETricuspid SEVERE
Pulmonic	MILDPulmonic MILD	MODPulmonic MOD	SEVEREPulmonic SEVERE

Treatment - indicate lesion severity and mark "STENT' if treated

Layout

LM (Left Main)None50%90%CTOSTENT

LM stent

• Yes
• No

LM stent number

LAD (Left Ant. Desc.)None50%90%CTOSTENT

LAD stent

• Yes
• No

LAD stent number

1DG (1st Diagonal)None50%90%CTOSTENT

1DG stent

• Yes
• No

1DG stent number

2DG (2nd Diagonal)None50%90%CTOSTENT

2DG stent

• Yes
• No

2DG stent number

SB (Septal Branch)None50%90%CTOSTENT

SB stent

• Yes
• No

SB stent number

LCx (Circumflex)None50%90%CTOSTENT

LCx stent

• Yes
• No

LCx stent number

1OM (1st Obtuse Marginal)None50%90%CTOSTENT

10M stent

• Yes
• No

10M stent number

2OM (2nd Obtuse Marginal)None50%90%CTOSTENT

20M stent

• Yes
• No

20M stent number

LPD (Left Posterior Desc.)None50%90%CTOSTENT

LPD stent

• Yes
• No

LPD stent number

RI (Intermediate Branch)None50%90%CTOSTENT

RI stent

• Yes
• No

RI stent number

RCA (Right Coronary)None50%90%CTOSTENT

RCA stent

• Yes
• No

RCA stent number

RPD (Post. Desc.)None50%90%CTOSTENT

RPD stent

• Yes
• No

RPD stent number

PL (Posterolateral)None50%90%CTOSTENT

PL stent

• Yes
• No

PL stent number

Bypass GraftNone50%90%CTOSTENT

Bypass Graft stent

• Yes
• No

Bypass Graft stent number

Other, fill in on line below*:None50%90%CTOSTENT

*Other, please specify:

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Number of lesions treated

Number of stents deployed

Highest ACT *

Click on what applies *

• Unprotected left main
• Last patent vessel
• IVUS
• 3-vessel disease
• Antegr. art. bypass
• Rotablation
• None

Layout

iVAC 2L start date *

(dd/mm/yyyy)

iVAC 2L start time *

Max. iVAC 2L flow(L/min)Choice 131.51.61.71.81.92.02.12.22.32.42.5Other, namely

iVAC 2L end date *

(dd/mm/yyyy)

iVAC 2L end time *

Access site *

Sheath (name/size/serial number) *Oscor Magnum 18FrMedtronic Sentrant 18FrOther, please specify below

*Other, please specify:

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Assist Mode *

• 1:1 synch
• 1:3 synch
• Internal

Total IV fluids (mL)

Hospital Admission *

Date

Time

(dd/mm/yyyy) (xx:xx)

Vasc. Closure *

• MANTA
• PROGLIDE
• SURGICAL
• Other, please specify below

*Other, please specify: *

Total contrast (mL) *

Hospital Discharge

Date

Time

(dd/mm/yyyy) (xx:xx)

Intraprocedural Events & Clinical Outcomes

Mark if present *

• Death (intraprocedural)
• Blood transfusion (red cells), Click Reason below:
• Hypotension (10 min with MAP
• Shock (30 min with SBP
• Cardiac Massage (CPR)
• Hemolysis (clin. Significant)
• Defibrillation/cardioversion
• Failure to implant
• Atropine/adrenaline use
• *Other support used, fill in below:
• Noradrenaline use
• Premature removal of iVAC 2L
• Dobutamine use
• Lesion to the aortic valve (TTE)
• Intubation (if emergent)
• Angiographic failure
• Dislocation of iVAC 2L
• Intrapr. Infusion weaning (dobutamine/ noradrenaline/ dopamine)
• None

Blood transfusion (red cells), Click Reason below: *

• Bleeding/ Severe anemia
• Hemolysis

*Other, please specify:

No Major adverse Events at 30 days

• No major events
• Major events: check below

Major Adverse events (mark if occurred)

	Pre Discharge	< 30 days	< 90 days	< 1 year
Cerebrovasc. event	Pre DischargeCerebrovasc. event Pre Discharge	< 30 daysCerebrovasc. event < 30 days	< 90 daysCerebrovasc. event < 90 days	< 1 yearCerebrovasc. event < 1 year
Acute MI	Pre DischargeAcute MI Pre Discharge	< 30 daysAcute MI < 30 days	< 90 daysAcute MI < 90 days	< 1 yearAcute MI < 1 year
Acute Kidney Injury	Pre DischargeAcute Kidney Injury Pre Discharge	< 30 daysAcute Kidney Injury < 30 days	< 90 daysAcute Kidney Injury < 90 days	< 1 yearAcute Kidney Injury < 1 year
Cardiac/vasc. operation	Pre DischargeCardiac/vasc. operation Pre Discharge	< 30 daysCardiac/vasc. operation < 30 days	< 90 daysCardiac/vasc. operation < 90 days	< 1 yearCardiac/vasc. operation < 1 year
Major bleeding	Pre DischargeMajor bleeding Pre Discharge	< 30 daysMajor bleeding < 30 days	< 90 daysMajor bleeding < 90 days	< 1 yearMajor bleeding < 1 year
Death	Pre DischargeDeath Pre Discharge	< 30 daysDeath < 30 days	< 90 daysDeath < 90 days	< 1 yearDeath < 1 year
Emergent Revasc.	Pre DischargeEmergent Revasc. Pre Discharge	< 30 daysEmergent Revasc. < 30 days	< 90 daysEmergent Revasc. < 90 days	< 1 yearEmergent Revasc. < 1 year

Pre support

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Heart rate

Pulmonary pressure

Blood pressure

Cardiac output

Sp02 (%)

mPCWP

Sp02 (%) (iVAC2L LEG/ CONTRALATERAL LEG)

During support (minimal 10 min)

Layout

Heart rate

Pulmonary pressure

Blood pressure

Cardiac output

Sp02 (%)

mPCWP

Sp02 (%) (iVAC2L LEG/ CONTRALATERAL LEG)

Post-removal

Layout

Heart rate

Pulmonary pressure

Blood pressure

Cardiac output

Sp02 (%)

mPCWP

Sp02 (%) (iVAC2L LEG/ CONTRALATERAL LEG)

We would greatly appreciate if you could inform PulseCath of any additional remarks or any adverse events detected post PCI and post discharge. Thank you for contributing to our PMS registry!

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RF-64-03 February 2023

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