International Atomic Energy Agency

Angiography Equipment

L4
 Educational objectives

What are equipment standards for

cath equipment (FDA, IEC),
particular needs for pediatric
patients.
What to look for while establishing
a cath lab.
Importance of testing equipment
performance.

Radiation Protection in Cardiology Lecture 4: Angiography equi 2

 Equipment standards
for Cath Lab

Radiation Protection in Cardiology Lecture 4: Angiography equi 3

 X-Ray Equipment Standards
And Regulations
Standards are consensus guides from
the manufacturing community, not
regulatory
Several groups set standards regarding
equipment, e.g., International
Electrotechnical Equipment (IEC)
Apply to electrical, mechanical, and
radiation safety
Apply to equipment at time of
manufacture and installation

Radiation Protection in Cardiology Lecture 4: Angiography equi 4

 What to look for while establishing a
cath. lab.
If the relevant Standards are fulfilled.
If a medical physicist is available.
If radiation protection tools are
available.
If patient dose measuring and recording
system is available.
If acceptance tests, commissioning and
quality assurance programme have been
foreseen.

Radiation Protection in Cardiology Lecture 4: Angiography equi 5

 What to look for while establishing a
cath. lab.
If the X rays system selected is
appropriate for the procedures to be
carried out in the catheterization
laboratory.
If some other relevant information
described in ACC/AHA Guidelines and
AAPM-70 (described in this lecture) have
been taken into account.

Radiation Protection in Cardiology Lecture 4: Angiography equi 6

 Outline

FDA, IEC and ACR recommendations

concerning X-ray equipment for
cardiology.
AAPM report and specific pediatric
equipment recommendations.
Key topics for cardiac X-ray equipment.
IAEA survey and importance of testing
equipment.
Patient dose reports and DICOM header
information.
Radiation Protection in Cardiology Lecture 4: Angiography equi 7
Limitation in entrance exposure rate

Federal Register: May 19, 1994.

21 CFR Part 1020.
Federal Performance Standard
for Diagnostic X-Ray Systems
and Their Major Components;
Final Rule.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Radiation Protection in Cardiology Lecture 4: Angiography equi 8
 Limitation in entrance exposure rate

The Standard for Diagnostic X Ray Systems

(May 19, 1994), limits the entrance exposure
rate of fluoroscopic x ray systems during
normal fluoroscopy to 10 R/min unless an
optional high-level control (HLC) is activated.
If HLC is activated, the entrance exposure
rate must be limited to 20 R/min.
The entrance exposure rate limits do not
apply during the recording of images.

Radiation Protection in Cardiology Lecture 4: Angiography equi 9

 Measuring
entrance dose and
image quality

Test object to
measure image
quality, at the
isocenter

Flat ionisation
chamber to
measure phantom
entrance dose

Radiation Protection in Cardiology Lecture 4: Angiography equi 10

Typically we can find the following
fluoroscopy setting:

Radiation Protection in Cardiology Lecture 4: Angiography equi 11

Typically we can find the following
cine setting

Radiation Protection in Cardiology Lecture 4: Angiography equi 12

 Proposed Rule
December 10, 2002

Radiation Protection in Cardiology Lecture 4: Angiography equi 13

 mGy (total)
mGy/min
(at 15 cm from the isocenter
towards the x-ray source)
Fluoroscopy time
Radiation Protection in Cardiology Lecture 4: Angiography equi 14
Radiation Protection in Cardiology Lecture 4: Angiography equi 15
 Fluoroscopic equipment manufactured on
or after May 19, 1995:

Shall not be operable if AKR is higher than

88 mGy/min (10 R/min).

Exceptions:

Limits: When a mode a high-level control is

88 mGy/min
180 mGy/min
activated: 180 mGy/min (20 R/min). A
continuous signal audible to the fluoroscopist shall
indicate that the high-level control is being employed.
During the recording of images (archiving of
fluoroscopic or radiographic images in analog format with
a video-tape or video-disc recorder does not qualify as an
exception).

Radiation Protection in Cardiology Lecture 4: Angiography equi 16

 IEC Standard
2000

Radiation Protection in Cardiology Lecture 4: Angiography equi 17

 IEC standard on Interventional
Radiology

Radioscopically guided invasive (and interventional)

procedures.
Interventional reference point.
Isokerma maps shall be provided.
The anti-scatter grid should be removable without the use of
tools.

Dosimetric indications: reference air kerma rate, cumulative

reference air kerma. cumulative area kerma product, (shall be
accurate to within 50 %).

Supplementary indications: cumulative time of radioscopy,

cumulative number of radiographic irradiations, integrated
reference air kerma.

Radiation Protection in Cardiology Lecture 4: Angiography equi 18

Transmission chamber
Lectureand collimators equi
(Siemens system)
4: Angiography
Radiation Protection in Cardiology 19
Radiation Protection in Cardiology Lecture 4: Angiography equi 20
 Collimation: Dual-shape collimators
incorporating both circular and elliptical
shutters may be used to modify the field
for cardiac contour collimation. Partially
absorbent contoured filters are also
available to control the bright spots
produced by the lung tissue bordering the
heart.

Radiation Protection in Cardiology Lecture 4: Angiography equi 21

 Philips systems

Radiation Protection in Cardiology Lecture 4: Angiography equi 22

Example of the influence of wedge filter in the skin dose (Vano)
Radiation Protection in Cardiology Lecture 4: Angiography equi 23
 Image intensifiers. Because of the necessity of
imaging large fields (e.g., for ventriculography,
aortography) as well as small fields (coronary
arteries), multimode (double or triple) cesium
iodide image intensifiers are recommended.
Formats available vary with the manufacturer but
are typically 9 in/ 6 in/4.5 in (9/6/4.5), 9/6, 10/4,
and 9/5.

Radiation Protection in Cardiology Lecture 4: Angiography equi 24

 Patient and Equipment Support: The ability to
obtain very steep sagittal plane angulation (in
excess of 45 ) is desirable.
An image intensifier with a diameter of more
than 9 in is not recommended for cardiac
catheterization laboratories because its size
interferes with the ability to obtain steep sagittal
angulation.

Radiation Protection in Cardiology Lecture 4: Angiography equi 25

 The operator should be made aware of the
cumulative amount of exposure time during the
procedure.
In training programs there should be a limit to
the amount of fluoroscopic time granted to a
trainee to complete a specific task, based on a
number of considerations such as the progress
being made and the complexity of the procedure.

Radiation Protection in Cardiology Lecture 4: Angiography equi 26

 A freely movable lead glass or acrylic shield
suspended from the ceiling should be used. Its
sterility may be maintained by using disposable
plastic covers.
Each procedure room should have a detailed
determination of exposure levels performed by a
qualified radiation physicist.
There is a tendency in the busy laboratory to
assign a low priority to preventive maintenance
and quality assurance inspections.
Radiation Protection in Cardiology Lecture 4: Angiography equi 27
 AAPM-70 (2001)
The generator should
be capable of
generating 80 to 100
kilowatts (kW) of power.
The generator design
should result in square
wave kVp pulses to
achieve optimum
patient dose savings.
Radiation Protection in Cardiology Lecture 4: Angiography equi 28
 AAPM-70 (2001)

Several manufacturers are using relatively

thick copper filtration and reduced kVp
during fluoroscopy to generate an energy
spectrum better matched to the K-edge of
iodine contrast media.
This technique requires high fluoroscopic
tube currents with the benefit of reducing
patient exposure to radiation while
improving image contrast.

Radiation Protection in Cardiology Lecture 4: Angiography equi 29

 AAPM-70 (2001)

For adult studies, a 9 to 11 inch (23

to 27 cm) size is used.
Pediatric cardiac studies use
smaller FoVs due to the small size
of the pediatric heart.
The 4.5 inch (11 cm) FoV would be
commonly employed for most
pediatric imaging studies.

Radiation Protection in Cardiology Lecture 4: Angiography equi 30

 AAPM-70 (2001). Pediatrics.

If the cath lab will serve the

pediatric population, the generator
design should allow high quality
imaging on patients which range in
size from 3 to 140 kilograms (kg).
This wide range of patient size
places additional demands on the
design of the generator.

Radiation Protection in Cardiology Lecture 4: Angiography equi 31

 AAPM-70 (2001). Pediatrics.

The generator design should allow

the mAs loading of the tube per cine
pulse to be varied from as little as
0.1 mAs (100 mA and 1 msec) up to
6 mAs (e.g., 800 mA and 7 msec) as
a function of patient size in order to
maintain a kVp operating range of 65
to 75 kVp.

Radiation Protection in Cardiology Lecture 4: Angiography equi 32

 AAPM-70 (2001). Pediatrics.

Cine frame rate capability should

extend up to at least 60 fps for small
children.
The generator should support an x-ray
tube with a minimum of three focal
spots. Patients up to 3 to 4 years old
can be imaged with an 0.3 mm focal
spot size, and patients up to
8 to 9 years old can be imaged with
cine using an 0.6 mm focal spot.

Radiation Protection in Cardiology Lecture 4: Angiography equi 33

 AAPM-70 (2001). Pediatrics.

The 0.3 mm focal spot can also be used

on small children by removing the anti-
scatter grid and employing a geometric
magnification factor up to 2.
The geometrical magnification method
for small children can also reduce patient
dose because the electronic magnification
modes of the image intensifier are avoided
and the Bucky factor due to the grid is
eliminated.

Radiation Protection in Cardiology Lecture 4: Angiography equi 34

 International Atomic Energy Agency

Cardiology equipment
key topics
 Key topics
Spatial beam modulation: collimation (and
virtual collimation), wedge filters, etc.
Temporal beam modulation: pulsed
fluoroscopy (grid controlled, temporal
integration, etc).
Beam quality modulation: extra filtering (Cu,
Ta, etc).
Last image hold.
Patient dose measurement, display and
archive.
New detectors (dynamic flat panel),
connectivity and DICOM compliance.
Radiation Protection in Cardiology Lecture 4: Angiography equi 36
 Control panel indications (Siemens
Lecture
Radiation Protection in Cardiology 4: Angiography equi system)
37
 X-ray room indications (Siemens
Lecture
Radiation Protection in Cardiology 4: Angiography equisystem)38
 Key topics
Ergonomy in the room and system
geometry.
Accidental stop of the system.
Dosimetric indications in the system and
inside the cath lab.
Protective tools in the system.
Operational modes and how they are
settled.
DICOM header information.
On line audit possibilities.

Radiation Protection in Cardiology Lecture 4: Angiography equi 39

 High filtration

The introduction of
additional filtration
in the X ray beam
(commonly copper
filters) reduce the
number of low
energy photons
and as
consequence,
saves skin dose for
the patients.

Radiation Protection in Cardiology Lecture 4: Angiography equi 40

 Reduction of Radiation Exposure with
extra filtration
Additional Cu filters can reduce the skin
dose by more than 70%.
Some systems affer variable extra
filtration (0.2 mm - 0.9 mm) that is
automatically set according to patient
weight and angulation of the C-arm.
Automatic filter insertion try to keep the
dose as low as possible without
degrading image quality.

Radiation Protection in Cardiology Lecture 4: Angiography equi 41

 Pulsed fluoroscopy

Pulsed fluoroscopy can be used as a

method of reducing radiation dose,
particularly when the pulse rate is
reduced.
But pulsed fluoroscopy does not
mean that dose rate is lower in
comparison with continuous
fluoroscopy!!.
Dose rate depends of the dose per
pulse and the number of pulses per
second.

Radiation Protection in Cardiology Lecture 4: Angiography equi 42

 Reduction of Radiation Exposure with
virtual collimation

Radiation-free
Collimation.
Manipulation of
diaphragms in Last
Image Hold.
No fluoroscopy
required.

Radiation Protection in Cardiology Lecture 4: Angiography equi 43

 International Atomic Energy Agency

Example of X-ray system

setting
APR Philips Integris H5000 Room 3, December 2001

Fluo low Fluo med Fluo high

Radiation Protection in Cardiology Lecture 4: Angiography equi 45
 International Atomic Energy Agency

IAEA survey 2001-2003

X-ray systems evaluated:

9-15 from 5 countries
 Very different dose/frame values have been found
Lecture 4: Angiography equi
Radiation Protection in Cardiology 47
Also different dose increase
Lecture with patientequi
4: Angiography
Radiation Protection in Cardiology
thickness48
Also different dose increase with fluoroscopy modes
Lecture 4: Angiography equi
Radiation Protection in Cardiology 49
 Conclusions from the IAEA survey

Patient dose and image quality

depend largely on the settings made
at the commissioning of the
radiological equipment.
For different systems and different
operation modes, entrance air kerma
can increase by a factor of 20
(including electronic magnification)
for the same patient thickness.

Radiation Protection in Cardiology Lecture 4: Angiography equi 50

 Conclusions from the IAEA survey

Increasing phantom thickness

increases dose by an additional
factor of up to 12.
Differences in radiation doses
from the evaluated systems show
a potential for dose reduction
whilst maintaining image quality.

Radiation Protection in Cardiology Lecture 4: Angiography equi 51

 Importance of testing X ray equipment

Characterization of the X- ray system,

that should be part of the acceptance
and status tests, should inform
cardiologists about the dose rates and
dose/frame for the different operation
modes and for the different patient
thicknesses. Image quality shall also be
evaluated.
Regular constancy checks should verify
if important changes could been
occurred.

Radiation Protection in Cardiology Lecture 4: Angiography equi 52

 International Atomic Energy Agency

Examples of patient dose

reports
 Example of the data included in the study report (Siemens)

Radiation Protection in Cardiology Lecture 4: Angiography equi 54

 Example of the
data included in
the dosimetric
report (Philips):

Philips Integris
5000:
Coronary
angiography
65% cine; 35%
fluoroscopy
13 series, 728
frames
1,54 Gy.cm2/min
0,368 Gy.cm2/10 fr
1 min fluoroscopy
=
39 fr = 3 s cine
Radiation Protection in Cardiology Lecture 4: Angiography equi 55
 International Atomic Energy Agency

Examples of information
contained at the DICOM
header
Radiation Protection in Cardiology Lecture 4: Angiography equi 57
Radiation Protection in Cardiology Lecture 4: Angiography equi 58
Radiation Protection in Cardiology Lecture 4: Angiography equi 59
 Summary
What to look for while
establishing a cath lab
FDA, IEC, ACR
recommendations
Specific aspects in paediatrics
Examples of patient dose
reports
Dose variation in cine & fluoro-
IAEA survey
DICOM header information
Radiation Protection in Cardiology Lecture 4: Angiography equi 60