Non Invasive Hemodynamic Monitoring

A Breakthrough Concept:PhysioFlowTM

Copyright : Manatec Biomedical, June 2005

Agenda

• Why Should I Measure Cardiac Output?• How Can I Measure Cardiac Output?• What is Impedance Cardiography?• Why PhysioFlow?• What are the benefits of PhysioFlow ?

Why Should I Measure Cardiac

Output?

1) Assess SHOCKED patients

2) Manage fluid and drug administration (plus weaning patients off ventilators)

3) Monitor unstable patients

Intensive Care

Physicians

1) Diagnose and follow up of Heart Failure and Hypertensive patients

2) Better manage of Bi-Ventricular PM patients

3) Improve sensitivity of CAD and dyspnoea diagnosis under exercise test

Cardiologists and

Internists

1) Physiology (extreme conditions, military)

2) Pharmacology (toxicology)

3) Sports medicine

Advanced Applications

and Research

How Can I Measure Cardiac Output?

INVASIVE

1) “Direct” Fick Method

2) Dye Dilution

3) Thermodilution (PA Catheter)

SEMI INVASIVE

1) Pulse Contour Analysis (PICCO)

2) Trans-Esophageal Doppler

1) “Indirect” Fick

2) Impedance Cardiography

NON INVASIVE

What is Impedance Cardiography? Emission of a low magnitude-high frequency electrical

signal though the thorax Measurement of the impedance modulations generated

by the cardiac blood flow Analysis of the pulsatile waveform and computation of

SV

CO = HR (ECG) . SV (ICG)

What is the Current Standard of ICG?

1. Impedance baseline (Z0) Thoracic Fluid Content (TFC)

2. The pulsatile waveform represents the circulating fraction of the TFC, which is the stroke volume

Volumetric approach

Kubicek

2max

2

0

)/.(..

Z

dtdZVETLSV

Srameck

0

)/.(. max

Z

dtdZVETVEPTSV

Z0 is sensitive to measurement conditions unreliable

Advanced PhysioFlow ICG

Morphological approach

Reduced limitations thanks to the absence of Z0

Normal Patients Heart Failure Patients Hyperkinetic Patients

Use of differential analysis on systolic impedance waveforms

PhysioFlow is …Accurate with Reproducible Results

Good correlation and agreement with reference techniques

Excellent test-retest coef. of variations

Not operator dependent Highly sensitive in tracking hemodynamic changes

2.5 5.0 7.5 10.0 12.5

-3

-2

-1

0

1

2

3

+ 2SD

- 2SD

CO : average of the two methods(L/min)

CO

: D

iffe

ren

ce

bet

we

en t

he

two

met

ho

ds

(L/m

in)

Comprehensive PhysioFlow

Parameters A more thorough and powerful diagnosis of patients is achievable through a combination of measured and computed parameters

HR, SV, CO, CI, VET, EF, Contractility INDEX

SVR, SVRi, LCWi

UNDER VALIDATION :

Early Diastolic Function Ratio : Assessing left ventricular filling problems

Example of PhysioFlow Parameters at Work

Trending on ICU patients

Detecting CAD during exercise test

Specific Display Hemodynamic Cross

Hyperkinetic

Septic Shock

Congestive Heart Failure

Allergic Shock

Neurotonic Hypertension

Vascular Hypertension

LCWI

SVRI

LCWI: Left Cardiac Work Index & SVRI: Systemic Vascular Resistance Index

PhysioFlow is …Expertise and Innovation

French Patent 1993 / US Patent 1997 4 phases of development

1989-1995 Dr. Jean Bour’s private R&D 1995-1999 Manatec, a R&D Company 1999-2005 Industrial phase 2006-? Handheld technology, OEM, FDA

Key market player through innovation and partnerships

It is totally non-invasive It requires only 6 pre-gelled electrodes It has a user-friendly software

With powerful data analysis and export functions

PhysioFlow is …Safe and Easy to Use

PhysioFlow has …Reduced Dependencies

No need for a specific or clean environment None of the major limitations of standard ICG apply

(except open chest surgery) Only electrical or mechanical interferences from some

other devices may impair measurements (electrosurgical instruments, high frequency ventilation…)

PhysioFlow Provides …Mutual Benefits to Patients /

Physicians Low-cost disposable sensors vs. expensive catheters Quick operation

Minutes vs. several hours for Swan-Ganz catheter No preventive maintenance dependability

More revenues Saving the cost of invasive procedures Expanding clinical benefits to many more patients

Conclusion

PhysioFlow is …

1. Non-invasive safe and easy to use

2. Accurate with reproducible results data can be trusted

3. Useable in most clinical settings

4. Cost effective mutual benefits to patients / physicians

Live Demonstrations (Q&A)

« The sphygmo-manometer would not be welcomed by the overworked and underpaid general practitioner already loaded with thermometer and stethoscope » - Blake E.: Recent British Researches on Arterial Tension. Med Times Gaz. 1895; 23:29

Case Studies : exercise test on athlete

Linear increase of cardiac output until max workload (32 l/min at 22 Km/h).

Case Studies : exercise test on untrained patient

Normal percentage of SV increment but flat trend after quick inital response

Case Studies : exercise test on CAD patient

SV decrases at 120 watts after having increased normally

Case Studies : exercise test on HF patient

No increase in SV

Case Studies : Legs Up Maneuver on HF patient

SV decrases : fluid overload

Case Studies : Adjustment of BIV Pacemaker

SV is better in LV-only mode compared to BIV and RV modes

Case Studies : Managing Hypertensive Patients

• The hemodynamic cross helps diagnose and treat HTN patients

Case Studies : Emergency Room

Septic shock : Increased LCWi Cardiac shock : Increased SVRi Depressed SVRi Depressed LCWi

Case Studies : Controlling unstable ICU patients

CO drops dramatically after infusion of atropine and recovers after fluid administration

Case Studies : Legs-up Maneuver on ICU patient

Shocked patient : increase of SV with increased preload. Indication for fluid administration

Case Studies : Controlling unstable ICU patients

Initial positive response after fluid administration, butSV decrases again after 35 min : probable fluid overload