Evaluation report

CHF Solutions
Aquadex Flexflow ultrafiltration system
CEP 07017
January 2008

Contents

Executive summary .................................................................................. 3

Introduction............................................................................................... 4
Product description................................................................................... 5
Methods.................................................................................................. 10
Operational considerations..................................................................... 11
Economic considerations ....................................................................... 15
Purchasing ............................................................................................. 16
Acknowledgements ................................................................................ 17
References ............................................................................................. 18
Author and report information................................................................. 19

CEP 07017: January 2008

Executive summary

The product
The CHF Solutions Aquadex Flexflow is indicated for use on heart failure patients with fluid
overload who have inadequate urine output. It uses ultrafiltration (UF)a nonpharmacological techniquefor removing excess fluid, optionally via peripheral venous
access.

Field of use
Although the use of ultrafiltration in the management of heart failure has been reported for
almost 30 years, its use in routine clinical practice is rare and it tends to be a treatment of
last resort when diuretics have ceased to be effective.
There has been research into the efficacy of ultrafiltration therapy in patients with moderate,
as well as severe, heart failure. Results suggest that it may be at least as effective as
intravenous diuretics, and may convey additional benefits, including a sustained
improvement in exercise capacity, and a reduced risk of readmission following initial therapy.

Methods
The evaluation brief was to carry out a review of the of the Aquadex Flexflow technology. In
addition we compared its specifications with examples of haemodialysis equipment which
have an ultrafiltration function.

CEP's verdict
This document should be read in conjunction with our evidence review (CEP 07016), which
reviews the existing clinical and economic evidence for ultrafiltration in the treatment of
congestive heart failure (CHF), and provides an economic analysis for the use of the
Aquadex FlexFlow.

The existing UK user base is low but user opinion was that the Flexflow equipment
was straightforward to use and maintain

We reached the same conclusion following our in-house assessment of usability

The instructions for use were comprehensive and clearly written

User training, delivered by the UK supplier, was good

Compared with other products, the Flexflow was of more compact size and the least
expensive but the consumables were more expensive

CEP 07017: January 2008

Introduction

Introduction
This evaluation report should be read in conjunction with our earlier evidence review [1],
which assesses the clinical and economic evidence for the use of ultrafiltration in the
treatment of congestive heart failure (CHF), and presents an economic analysis for the use
of the Aquadex FlexFlow. This evaluation report concentrates on the practical, technical and
operational issues associated with the device.
The Aquadex Flexflow ultrafiltration system (Figure 1) is intended to remove excess fluid
from patients with decompensated CHF.
CHF is a chronic inability of the heart to maintain an adequate output of blood from one or
both ventricles, resulting in congestion and over-distension of certain veins and organs with
blood. Diuretic drugs are typically used to help reduce fluid overload in these patients, but a
substantial proportion of patients develop diuretic resistance. Ultrafiltration is an alternative
therapy for reducing fluid overload in CHF patients and may be of most benefit in the diuretic
resistant groups.

CEP 07017: January 2008

Product description

General
The Flexflow performs slow continuous ultrafiltration (SCUF) where blood is withdrawn
(Figure 2) via a catheter from the patient and through a primary circuit, the main components
of which are a peristaltic pump and a haemofilter built into a clear plastic cartridge. The blood
flow rate is adjustable between 10 and 40 ml/min. Ultrafiltrate, consisting principally of water
and sodium chloride, is withdrawn from the haemofilter by means of a second peristaltic
pump at a rate adjustable between 0 and 500 ml/hr. The ultrafiltrate passes into a collection
bag where the quantity collected is weighed prior to disposal. Blood cells and major plasma
proteins are too large to diffuse through the haemofilter and are returned to the patient via
the catheter.

Theory of operation
Ultrafiltration is the extraction of water and low molecular weight solutes through a semipermeable membrane (diffusion) due to a pressure gradient. The gradient can be achieved
by pressurising the fluid on one side of the membrane or depressurising the fluid on the other
side, or a combination of the two.
The membrane material used in the Flexflow's haemofilter is permeable to all molecules
having a molecular mass of less than 65 kDa. Thus water molecules and low molecular
weight solutes easily diffuse through the membrane but blood cells and higher molecular
weight proteins such as albumin cannot pass through.
Blood enters the circuit via a withdrawal catheter at point A in Figure 2 and into the
haemofilter cartridge. The cartridge contains numerous hollow fibres, effectively a bundle of
very thin tubes composed of membrane material, that link the input and exit ports of the
cartridge, i.e. C and D in Figure 2. The effective surface area of the membrane material in
the fibre bundle is 0.12 m2 (Figure 3). Blood flowing into the cartridge passes through the
fibre bundle towards the exit. When the ultrafiltrate pump operates, negative pressure is
applied to the external surfaces of the hollow fibres causing ultrafiltrate to diffuse through the
fibre walls to fill the space between the fibres in the cartridge body before exiting towards the
collection circuit and into the collection bag.

CEP 07017: January 2008

Product description

Figure 1 Aquadex console

CEP 07017: January 2008

Product description

Figure 2 Aquadex extracorporeal circuit

Haemofilter
Cartridge

Source: Aquadex Flexflow user's guide

CEP 07017: January 2008

Product description

Figure 3 Diagram of hollow fibre membrane

Using the Aquadex Flexflow

The Flexflow is a mains powered device with a backup battery of 30 minute capacity. It
consists of a console and a disposable blood circuit set. The console houses all the pumps,
alarms, controls and display (Figure 1). The disposable set consists of the blood circuit and
ultrafiltrate lines described above and shown in Figure 2 above the dotted line.
Ultrafiltrate and blood flow rates are set according to the needs of the treatment. Blood flow
rate from the patient is in the range 1040 ml/min and ultrafiltrate removal in the range
0500 ml/hour giving up to 4 litres in an 8 hour treatment session. Ultrafiltrate is collected in
a 1 litre bag. When full, ultrafiltration stops (though not blood flow) until the bag is emptied.
The blood circuit has a capacity of 33 ml, measured between withdrawal and return
catheters; thus the extracorporeal transit time is between 49.5 and 198 seconds depending
on the selected flow rate.
Sensors are incorporated to detect air bubbles in the blood circuit line, blood leaks in the
ultrafiltrate line and pressure in both lines. A weight sensor detects when the ultrafiltrate bag
is full.
The main console has 21 control buttons and five LED indicators:

On/Off

Alarm silence with amber indicator: two minute alarm mute

Four buttons that control the unit's operational modes:

o STOP with amber indicator: the switch-on modeboth pumps off
o PRIME with green indicator: used to prime the blood circuit with saline and
remove air ready for patient connection
o MANUAL with green indicator: press and hold to advance saline, blood or air
through the circuit; available only in stop mode when priming is complete
o RUN with green indicator: both pumps operate at the set blood flow rate whilst
fluid is removed at the set ultrafiltration rate

CEP 07017: January 2008

Product description

Accept: confirms selections during prime and set-up

Clear: to cancel/clear/silence alarm and on-screen selections

Up/down: highlight/adjust on-screen settings and functions

Blood Flow: sets the flow rate between 1040 ml/min in 5 ml steps; ultrafiltration will
not occur until blood flow is >88% of the set UF rate

UF Rate: sets the ultrafiltration rate between 0500 ml/hr in 10 ml steps; a UF rate
exceeding 21% of the blood flow rate is not permitted, as illustrated below:

Set Blood Flow rate (ml/min)

Max permitted UF rate (ml/hr)

10
15
20
25
30
35
40

120
180
250
310
370
440
500

Menu: available functions include:

Alarm/Event history (200 entries)
Enable/disable blood leak detection (default enabled). Continuous screen
warning if disabled
o Loading the blood circuit: a 13-step interactive instruction guide on preparing the
device for treatment
Help: contextual help about current alarm or activity. Also specific menu topics:
choosing a catheter; loading the blood circuit; setting UF rate; setting blood flow;
'stop' mode; 'prime' mode; 'run'; 'manual' mode
o
o

mmHg: displays current pressures of withdrawal (Pw), infusion (Pi) and ultrafiltrate (Pu)

Graph: icon button duplicates action of 'mmHg' above

Screen contrast

F1, F2, F3, F4 currently not used

LED Indicators: AC power (green); battery power (flashing amber);

system indicators: Alarm (red); Alert (amber); Normal (green).
The internal 12V nickel metal hydride battery is specified to provide 30 minutes of backup
operating time and can be recharged in 4 hours. There are 48 different alarm messages. The
device has a rear mounted RS232 serial data port but no information is provided on its use.

CEP 07017: January 2008

Methods

Methods
A protocol was designed specifically for this evaluation and comprised:

description of device and key functions

assessment of build quality

assessment of user training and the instructions for use

assessment of ease of using Aquadex Flexflow console

evaluation staff assessment following product training

user feedback

comparison with other equipment that performs ultrafiltration

No technical performance tests were carried out.

CEP 07017: January 2008

10

Operational considerations

Product
The Aquadex Flexflow carries CE marking in respect of the Medical Devices Directive and
the manufacturer states compliance with electrical safety standard IEC 60601-1.

Alternative technologies
The Aquadex Flexflow system with its low flow rates is designed for peripheral venous
access as well as central venous access which is used by haemodialysis equipment. No
other product has been identified that is designed solely for ultrafiltration therapy but a
number of haemodialysis products have ultrafiltration capability (Table 1).
Advantages of Aquadex Flexflow
Lower unit price

Significantly more compact size and reduced weight

Peripheral venous access for outpatient applications

Battery backup

Disadvantages of Aquadex Flexflow

Single therapy device

High cost of single-treatment filter circuit

CEP 07017: January 2008

11

Operational considerations

12

Table 1. Comparative specifications

Manufacturer

CHF Solutions

Edwards
Lifesciences

Gambro

Gambro

Model
Price (ex VAT)
Unit
Filter circuits

Aquadex FlexFlow

Aquarius ABP

Prisma System

Prisma Flex

12000
600

16500
20 (typical)

12500
90 (typical)

17300
110 (typical)

Physical data
Weight
Dimensions (H x W x D)
Footprint ( W x D)
Power supply
Back-up battery
Therapies provided

9.5 kg
38 x 25 x 25 cm
61 x 61 cm
ac mains
30 min
SCUF

75.0 kg
172 x 66 x 60 cm
55 x 65 cm
ac mains
none
SCUF, CVVH, TPE
CVVHD, CVVHDF

25.0 kg
146 x 66 x 60 cm
not known
ac mains
none
SCUF, CVVH, TPE
CVVHD, CVVHDF

60.0 kg
162 x 49 x 30 cm
63 x 60 cm
ac mains
none
SCUF, CVVH, TPE
CVVHD, CVVHDF

Accuracy
Blood

10%
10, 15, 20, 25, 30,
35, 40 ml/min

10%
10 to 180 ml/min
(5 ml/min steps)

10%
10 to 450 ml/min
(10 ml/min steps)

Ultrafiltration removal
rate:

0 to 500 ml/h
(10 ml/h steps)

5%
Adult:
30 to 450 ml/min
(10 ml/min steps)
Paediatric:
10 to 200 ml/min
(2 ml/min steps)
Adult: 0 to 2000 ml/h
(10 ml/h steps)
Paediatric:
0 to 1000 ml/h
(1 ml/h steps)

0 to 2000 ml/h
(10 ml/h steps)

0 to 2000 ml/h
(10 ml/h steps)

Flow rate ranges

Pressure monitoring
Sensor accuracy
Access
Return
Pre-filter
Filtrate
Fluid control
Measuring scales range
Safety systems
Air detector
Blood leak detector

Display

(5 mmHg + 5% of
reading)
-350 to 500 mmHg
-350 to 500 mmHg
n/a
-350 to 500 mmHg

5 mmHg

10% of reading

10% of reading

-250 to 200 mmHg

-50 to 350 mmHg
-150 to 500 mmHg
-400 to 400 mmHg

-250 to 50 mmHg
-50 to 350 mmHg
-50 to 500 mmHg
-350 to 50 mmHg

-250 to 300 mmHg

-50 to 350 mmHg
-50 to 500 mmHg
-350 to 50 mmHg

0.1 to 1.5 kg

0 to 30 kg

not known

0 to 11 kg

50 l at 40 ml/min
> 2% Hct in
ultrafiltrate

not known
2 or 4 ml blood/litre
filtrate at Hct 32%

15 cm monochrome

26 cm colour

10 l
0.35 ml/min
(Hct 25% at max.
flow rate)
not known

20 l
0.35 ml/min
(Hct 32% at max.
flow rate)
30.5 cm colour

Notes CRRT Continuous Renal Replacement Therapies

SCUF Slow Continuous Ultrafiltration
CVVH Continuous Venovenous Haemofiltration

CEP 07017: January 2008

CVVHD Continuous Venovenous Haemodialysis

CVVHDF Continuous Venous Haemo Diafiltration
TPE Therapeutic Plasma Exchange

UF Ultrafiltration
Hct Haematocrit

Operational considerations

13

Usability
Using the Flexflow console
We used the equipment in the laboratory by circulating water through the primary circuit. The
patient connections were simulated by inserting the withdrawal and return catheters into a
filled water container. The manufacturer's representative gave his standard training
demonstration of the complete process of preparing the device for use, priming the circuits,
followed by ultrafiltration. Each staff member then repeated the process under his
supervision and again unsupervised at a later date.
We had no difficulty in using the controls and screen displays were clear with good
interactive help easily available if necessary. The safety features and alarms (bubbles, blood
leak, pressure limits) worked clearly and unambiguously. Our conclusion was that the
equipment was straightforward to use after product training.
Constructional quality
The device and accessories were constructed from high quality durable materials, and
moving parts operated smoothly and silently.
User experience
There were too few users to carry out a meaningful user survey. We asked a consultant who
is currently assessing the Flexflow's suitability for use in his department to give his views on
ease of use and he replied as follows.
"We are currently evaluating the device in Derby. We have so far treated 4 patients with it: a
total of 8 treatments. We have had rep support with each treatment. We are doing the
therapy on a general cardiology ward as I felt it important we prove that the system does not
require ITU/HDU care. Impressions are favourable. The system is very easy to set up (with
on screen guides); we have only used it with peripheral cannulae and have not required so
far to put a central line in. It seems to work well and ultrafiltration of between 18003000 ml
of fluid has been obtained each time with no complications or patient harm. The controls are
intuitive and simple to use. If we do adopt it, I feel our nursing staff will be able to operate it
independent of rep support within a short time."
Training
The trainer had a professional healthcare background and delivered a two-hour training
session, briefly described above, to a high standard. He carefully assessed our individual
practice sessions to ensure that we could prepare the Flexflow for use and operate it safely
and effectively. He would normally spend considerably more time training medical staff and
be in attendance throughout a full patient treatment.
Instructions for use
The user instructions, including servicing and maintenance guidance, were comprehensive
and clearly written.

CEP 07017: January 2008

Operational considerations

14

Consumables
UF500 blood circuit set (see Figure 2).
Catheter(s) - an infusion and withdrawal catheter plus associated extension sets if the
catheters do not have integral extensions or a single catheter with an infusion and withdrawal
line and integral extensions.
Saline - minimum of 200 ml for priming the device. Heparin must be added ro the saline to give
a final concentration of 40 units heparin / ml.
Anti-coagulation during therapy for the patient during treatment, when directed by the
clinician e.g. intravenous bolus of Heparin (10-20 units per kg of body weight).
This list is not exhaustive and other small items may be required (e.g. syringes to extract air
from the circuit).

Servicing and maintenance

Cleaning and disinfection
The cleaning and sterilisation procedures appeared straightforward.

The manufacturer recommends the unit be cleaned after each patient treatment, as
follows:
o

use a mild soap solution to clean spills from the surface of the console

disinfect console surfaces using 10% bleach solution or 95% isopropyl alcohol

clean the tubing path through the air and blood leak detectors; use a flossing
action to clean inside the detector with a lint-free cloth and warm water; dry
thoroughly

remove the pumps, clean them, then reassemble.

Periodic maintenance
The manufacturer recommends the following:
o

recharge the backup battery every month or as needed: connect the console
to AC power for 6 hours; the battery also charges during AC operation

the battery is designed for two years of normal use and must be replaced at
this time

device must be calibrated once per year and verified to have correct alarm
operation every two years.

CEP 07017: January 2008

Economic considerations

15

Costs
The list price and consumable costs of the Flexflow are shown in Table 1.
The UK suppliers state that:

the expected service life of the Aquadex system is at least five years

on expiry of the guarantee, a service agreement is available

the service agreement covers preventative maintenance, such as calibration, alarm

checks etc. The cost of the agreement without parts is 1600 per annum. All
maintenance is covered by the agreement and is carried out by qualified Kimal
personnel

leasing costs are 500 per month which includes servicing and maintenance.
Leasing reduces the circuit costs from 600 to 450. The supplier offers volume
discountsfor instance, the price for 30 or more circuits per year would be 550
rather than 600.

Economic analysis
An economic analysis is provided in our previous evidence review [1].

CEP 07017: January 2008

Purchasing

16

Contact details
Product support
Supplier

Kimal PLC
Arundel Road
Uxbridge
Middlesex
UB8 2SA
Tel: 01895 270 951
Fax: 01895 274 035
www.kimal.co.uk

Manufacturer

CHF Solutions Inc.

Brooklyn Park, MN 55428, USA
www.chfsolutions.com

Guarantee

CEP 07017: January 2008

12 months

Acknowledgements

17

We would like to thank the following for their help in producing this evaluation report:
Dr S Burn, consultant cardiologist, Derbyshire Royal Infirmary, for providing user comments.
Kimal PLC, who loaned an Aquadex Flexflow to the evaluation team.

CEP 07017: January 2008

References

18

[1] NHS Purchasing & Supply Agency, Centre for Evidence-based Purchasing. Evidence
review: Ultrafiltration therapy for fluid overload in heart failure. CEP 07016: December 2007.

CEP 07017: January 2008

Author and report information

Evaluation report:
CHF Solutions, Aquadex Flexflow
Ultrafiltration System
J A Menes
D R Bousfield
E S Colechin
C A Reay
A J Sims
Regional Medical Physics Department
Freeman Hospital
High Heaton
Newcastle upon Tyne
NE7 7DN
Tel: 0191 2137787
Email: RMPDFHevaluation@nuth.nhs.uk
Web: www.rmpd.org.uk

About CEP
The Centre for Evidence-based
Purchasing (CEP) is part of the Policy and
Innovation Directorate of the NHS
Purchasing and Supply Agency. We
underpin purchasing decisions by
providing objective evidence to support the
uptake of useful, safe and innovative
products and related procedures in health
and social care.
We are here to help you make informed
purchasing decisions by gathering
evidence globally to support the use of
innovative technologies, assess value and
cost effectiveness of products, and
develop nationally agreed protocols.

CEP 07017: January 2008

19

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