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Cardiovascular Catheterization Standards |
Appendix
B
Fluoroscopy:
Equipment and Instrumentation
When fluoroscopy is required, equipment
and instrumentation must include, but not limited to:
1.4.7B A
fixed or portable, single or biplane angiography and/or fluoroscopy system that
must meet the following specifications:
i. high
quality, subtracted digital imaging;
ii. road-mapping
(recommended) with ability to refer back to an unsubtracted live image;
iii. last
image hold is desirable;
iv. pulsed
fluoroscopy is desirable;
v. dose
measurement capability and/or fluoro time;
vi. Digital
Imaging and Communications in Medicine (DICOM) compatible digital image storage
with capability of storing uncompressed images on portable format without loss
of image resolution (as applicable);
vii. ability
to display and review prior relevant images during the procedure is desirable;
viii. minimum
detector diameter of 9 inches;
ix. minimum
spatial resolution of matrix of 1000 x 1000;
x. minimum
contrast resolution to see the 1.5 mm hole in a standard phantom (see Page 4,
Section 4B (low contrast performance) of Guidance Document Fluoro QA Guide
posted at https://intersocietal.org/document/fluoro-quality-assurance-guide.
xi. image
monitor performance using the Society of Motion Picture and Television
Engineers (SMPTE) pattern; and
xii. for
equipment installed before 2006 that does not display cumulative dose and or
dose area product (DAP), documentation of fluoroscopy time and the number of
images per procedure is acceptable.
When
performing structural heart interventions in the adult patient:
1.9B Any
procedure where a patent foramen ovale (PFO) or patent ductus arteriosus (PDA)
persists into adulthood or surgical repair of acquired heart disease requires
an intervention, but not limited to:43
i. transcatheter
closure device for a PFO;
ii. transcatheter
closure device for a PDA;
iii. transcatheter
closure device for a secundum atrial septal defect (only in the absence of
other congenital heart defects);
iv. ventricular
septal defect (small and only in the absence of other congenital heart defects);
v. transcatheter
occlusion of the left atrial appendage (only in the absence of a congenital
heart defect(s));
vi. occlusion
of a paravalvular leak;
vii. post-myocardial
infarction ventricular septal rupture;
viii. interventions
(e.g., coil/closure device, etc.) in a repair of one of the procedure types
listed above;
ix. other.
When
performing complex congenital heart defect (CHD) interventions in the adult
patient:
1.10B Any
intervention, other than transcatheter valve replacement, where the following
CHD is present (pre- or post-operative), but not limited to:42,43,44
i. atrioventricular
septal defect (AVSD), also known as atrioventricular canal (AVC), also known as
complete atrioventricular canal (CAVC);
ii. tetralogy
of Fallot (ToF);
iii. transposition
of the great arteries (d-TGA or l-TGA);
iv. coarctation
of the aorta (CoA);
v. Shones disease
(mitral stenosis, sub aortic/aortic stenosis, coarctation of the aorta);
vi. total or
partial anomalous pulmonary venous return (TAPVR, PAPVR), also known as TAPVC
or PAPVC;
vii. Ebstein’s
anomaly (ventricularization of the tricuspid valve);
viii. single
ventricle (Left or Right);
ix. truncus arteriosus;
x. ventricular
septal defect (VSD);
xi. pulmonary
stenosis (interventions other than TPVR);
xii. bicuspid
aortic valve (BAV) (interventions other than TAVR);
xiii. any
procedure where a surgical repair of a CHD requires an intervention, but not
limited to:
a. dilatation
of a conduit;
b. fenestration of a baffle or a closure of a
fenestration of a baffle;
c. coil /
closure device in the presence of a repair of one of the CHD listed above (not
PFO or PDA closure.
xiv. other.