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CHAUR
Pav. Ste Marie
Trois Rivières
Lessons
From the Prospective & Randomized
CRASOC I, II, III
Studies
V Dangoisse
CHAUR
Pav. Ste Marie
Trois Rivières
NO Conflict of interest
with my presentation
CHAUR
Pav. Ste Marie
Trois Rivières
Puncture Needle dedicated to the Radial Artery
CHAUR
Pav. Ste Marie
Trois Rivières
Puncture Needle dedicated to the Radial Artery
V Dangoisse
CHAUR
Pav. Ste Marie
Trois Rivières
GO TO AIM RADIAL 2017
EU US
A Family of Guiding Catheters
dedicated for the Radial Artery Access
CHAUR
Pav. Ste Marie
Trois Rivières
WHY
T R A is so Crucial ?
T R A (-PCI)
S A V E S L I F E S
(more than TFA)
2 Problems
T R A for Coronary Interventions
“Even believers in TRA recognize the technique
will continue to challenge operators in 2 ways:
the radial artery occlusion (RAO) and
the small artery size.“
“Even believers in TRA recognize the technique
will continue to challenge operators in 2 ways:
the radial artery occlusion (RAO) and
the small artery size.“
V Dangoisse et al
,(Am J Cardiol 2017;120:374e379)
VD 2007VD 2009
“How well it’s looking
the day after..”
R A O should be
bannished
R A O should be
bannished
RADIAL
RAO
Problem
“Il FAUT
SAUVER
LE
SO
LDAT
RADIAL”
CHAUR
Pav. Ste Marie
Trois Rivières
SAVING Private radial
MINIMIZING the AGGRESSION
Puncture Related
Catheters Related
Compression Related
VD Needle
VD GC Shapes
VD CRASOC
Studies
V Dangoisse et al,
(Am J Cardiol 2017;120:374-379)
3616 TR Access
Minimizing Injury
Puncture
Hemostasis Step
(compression)
Time of Compression
Degree of Compression
Catheters
CRASOC I, II, III: METHODS
The TR Band (Terumo ®)
allows
Selective radial artery compression
and
Precise control of Intensity
+
control of Duration
Manufacturer instructions for defining the intensity of the
compression are “empirical”
(“inflate 13 to 18 cc of air”…)
And the Manufacturer do not provide instructions for the
duration of the compression…
METHODS
Controlling the VOLUME of
AIR pushed in the TR-Band
Allows a PRECISE
CONTROL
Over the INTENSITY of
the external compression
Controlling the TIME of
PERMANENT INFLATION
Allows a PRECISE
CONTROL
Over the DURATION of
the external compression
Controlling the TIME of
PERMANENT INFLATION
Allows a PRECISE
CONTROL
Over the DURATION of
the external compression
CRASOC
I II III
13cc vs 10ccVolume 10cc 10cc
Time 4h 3h vs 2h 2h vs 90’
(Glidesheaths 5+ 6)
Random 1 / 2 1 / 1 3 / 1
METHODS
Randomization Method:
BY WEEKS
Random 1 week 10cc*/2h vs. Random 3 weeks 10cc*/11/2
h
Crasoc III
* (+ 2cc if bleeding at the time sheath’s removal)
Selection of Patients:
Included: all catheterized patients
returning to the Cardiac Ward
Excluded Patients:
Missing Volume of air data (cath lab nurses)
Missing 24h Nurse Evaluation
Missing Doppler Evaluation
Sent to another ward service
Selection of Patients:
Included: all catheterized patients
returning to the Cardiac Ward
Excluded Patients:
Missing Volume of air data (cath lab nurses)
Missing 24h Nurse Evaluation
Missing Doppler Evaluation
Sent to another ward service
Right /L RA
5F/ 6F
PCI / no pci
Age
F/M (%)
Wrist diam. (cm)
Weight (kg)
Height (cm)
BMI
IIb/IIIa inh.
Fluoro
(sec)
Dye
(ml)
DAP
(Gy/cm2
)
Group (10cc/2h versus 10cc/11/2
h)
METHODSDATA to be recorded/analyzed
+ N (cc) effectively used at the exit from the cath lab room
Clin variablesClin variables Diabetes H B P Chol on R/
Family HxSmoking P V D
Physical
variables
Physical
variables
Procedural
variables
Procedural
variables
RESULTS
variables
RESULTS
variables
RAO-Nurse (+ or - & if doubtful = (-))
RAO-Doppler (+ or - & if doubtful = (-))
Re-Bleeding/compression
Events related to the vasc access
RAO-Nurse (+ or - & if doubtful = (-))
RAO-Doppler (+ or - & if doubtful = (-))
Re-Bleeding/compression
Events related to the vasc access
Wrist diam. (cm)
METHODS
PRIMARY Endpoint:
“RAO-Nurse”
defined as Absence of Pulse and Oxygene Saturation
When compressing the Ulnar artery with Plethysmography by the attending Nurse
Secondary Endpoint:
1/“RAO-Doppler”
performed when RAO-Nurse is present and defined as absence of a positive (anterograde) Doppler signal
2/ Re-Bleeding/compression after 2hr/11/2
h
“secondary outcome”:
any complication related to the arterial access site
(see flow chart)
RASOC I 13 vs.10cc - 4H________________________________________
Randomized Patients (1 for 2) in
“NORMAL” (13 cc, as the minimum suggested by Terum
LOW INTENSIT
(10 c
FOR 4 hours of permanent inflat
CRASOC II 10cc-3H vs. 10 cc-2H__________________________
Randomized Patients (1 for 1) int
“SHORT” COMPRESSION : 3
v
“SHORTER” COMPRESSION : 2h
WIT
LOW INTENSITY (10 cc) of permanent inflatio
+ 2cc
if
immediate
bleeding
+ 2cc
if
immediate
bleeding
1937 Patients1937 Patients
942 Patients942 Patients
CRASOC III 10cc 2 vs 11/2
h 5FS
What is the BENEFIT OF
further REDUCING THE DURATION (to 90 minutes)
&
What is the benefit of
REDUCING THE SIZE OF THE SHEATH
5F to 5FS
** Crasoc I and II
Ref:JACC-Cardiovasc interventions, feb 2016, 9;4,Ss crt-200.12
758 TRA758 TRA
2 cc removed
TrBand removed
Our working flow chart:
Cardiology Ward
Dedicated Database for TRA
1/ KT step: cathlab nurses/techn/Md
Clin variablesClin variables
Physical
variables
Physical
variables
id of the
procedure
89%
8%
2%
Figure 1 Volume of air (cc) needed to obtain hemostasis after TRA
1679 patients (Crasoc II & III)
559
179
506
435
499
161
389
446
CRASOCs studies
10 cc is far enough for the majority of Pts.
V Dangoisse et al,
(Am J Cardiol 2017;120:374e379)
“Be Gentle”
ResultsResults
2016
2009-11
2014
Glidesheath
+
10 cc
+
90 min
± 2,5%
(3616 Patients)
± 10% RAO Nurse
NNTH = 21
(we save 1 artery for 21 patients treated)
V Dangoisse et al,
(Am J Cardiol 2017;120:374e379)
CRASOCs studiesResultsResults
4.2 % RAO Doppler
2016
2009-11
2014
Glidesheath
+
10 cc
+
90 min
0,26%
NNTH = 34
(we save 1 artery for 34 patients treated)
V Dangoisse et al,
(Am J Cardiol 2017;120:374e379)
(3616 Patients)CRASOCs studiesResultsResults
The prize to pay…
re-2cc
re compr
It’s easy to manage the problem
V Dangoisse et al,
(Am J Cardiol 2017;120:374e379)
Duratio
n
Duratio
n
Intensit
y (Vol
cc)
Intensit
y (Vol
cc)
“Gentle & Short”
compression
“Patent"“Patent"
14% more RAO by + 1cc (> 10cc); 49% more RAO for 1h more compression time (> 2h)14% more RAO by + 1cc (> 10cc); 49% more RAO for 1h more compression time (> 2h)
V Dangoisse et al,
(Am J Cardiol 2017;120:374e379)
O. R. Univariate O.R. Multivariate
95 % C.I.
(Confidence Interval)
Pvalue
13cc vs 10cc 1.16 1.16 [0.96 - 1.39] 0.113
3h vs 4h 0.8 0.84 [0.64 - 1.08] 0.185
2h vs 4h (crasoc II) 0.62 0.64 [0.46 - 0.85] 0.004
2h vs 4h (crasoc III) 0.65 0.69 [0.41 - 1.04] 0.116
1h30 vs 4h (crasoc III) 0.57 0.58 [0.42 - 0.78] 0.001
Height (+ 10 cm) 0.78 0.78 [0.66 - 0.91]
0.002
IIb.IIIa 1.45 1.62 [1.04 - 2.47] 0.03
Diabetes 0.92 0.72 [0.49 - 1.02] 0.071
Hypertension 1.55 1.78 [0.92 - 3.2] 0.066
PVD 2.15 1.56 [0.96 - 2.47] 0.063
Cholesterol 0.69 0.72 [0.47 - 1.07] 0.111
Table 3 Uni vs. Multivariate analysis (forward model), Odd Ratio for potential risk factors
the patient height was the most predictive variable linked to the RAO (or the final patency)
after TRA; for 10 cm above or below 169 cm, there was 22% less or more RAO nurse
(9% to 34%, p 1 4 0.0022).⁄
V Dangoisse et al,
(Am J Cardiol 2017;120:374e379)
169cm +/-
“the patient’s height is possibly the best indicator of the patient’s
radial artery size and the height largely outweighs all the other
recorded physical variables, including the wrist diameter (measured
for all cases). This makes sense: a larger vessel will resist more
easily the catheterization-related trauma. Trying to relate all the
clinical variables to their influence on the vessel size is tempting: for
example, hypertension could induce a positive vessel remodeling and
a larger artery with less RAO after TRA. Diabetes and peripheral
vascular disease will lead to a negative remodeling, smaller vessels,
and more RAO.”
V Dangoisse et al,
(Am J Cardiol 2017;120:374e379)
…Trying to relate all the clinical variables to their influence on
the vessel size is tempting:
for example,
hypertension may induce a positive vessel remodeling and
a larger artery
with less RAO after TRA.
Diabetes and peripheral vascular disease
will lead to a negative remodeling, smaller vessels,
and more RAO.”
V Dangoisse et al,
(Am J Cardiol 2017;120:374e379)
CHAUR
Pav. Ste Marie
Trois Rivières
CAUTION
Results of CRASOC Studies:
…”optimizing the hemostasis step on top of using the
recognized methods favoring the radial artery patency:
liberal use of heparin
use of hydrophilic sheaths
reduction in the catheter size to 5F
(including for PCI, performed in 5F for more than 80%
of procedures in CRASOC I and II)
and reduction in the sheath diameter (systematic use of GS
Slender for the CRASOC III study) “
V Dangoisse et al,
(Am J Cardiol 2017;120:374e379)
These results are obtained…
CHAUR
Pav. Ste Marie
Trois Rivières
MINIMIZING the AGGRESSION
Compression Related
Keep it SOFT
Keep it Short
Be Gentle(man)
Radial
V Dangoisse
CHAUR
Pav. Ste Marie
Trois Rivières
GO TO AIM RADIAL 2017
10 cc (+ 2)
90’
then (-) 2 cc
for 30-60’
-end-
In Summary
The Radial Artery will thank you

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14 Dangoisse aimradial20170921 CRASOC studies

  • 1. CHAUR Pav. Ste Marie Trois Rivières Lessons From the Prospective & Randomized CRASOC I, II, III Studies V Dangoisse
  • 2. CHAUR Pav. Ste Marie Trois Rivières NO Conflict of interest with my presentation
  • 3. CHAUR Pav. Ste Marie Trois Rivières Puncture Needle dedicated to the Radial Artery
  • 4. CHAUR Pav. Ste Marie Trois Rivières Puncture Needle dedicated to the Radial Artery
  • 5. V Dangoisse CHAUR Pav. Ste Marie Trois Rivières GO TO AIM RADIAL 2017 EU US A Family of Guiding Catheters dedicated for the Radial Artery Access
  • 6. CHAUR Pav. Ste Marie Trois Rivières WHY T R A is so Crucial ? T R A (-PCI) S A V E S L I F E S (more than TFA)
  • 7. 2 Problems T R A for Coronary Interventions “Even believers in TRA recognize the technique will continue to challenge operators in 2 ways: the radial artery occlusion (RAO) and the small artery size.“ “Even believers in TRA recognize the technique will continue to challenge operators in 2 ways: the radial artery occlusion (RAO) and the small artery size.“ V Dangoisse et al ,(Am J Cardiol 2017;120:374e379)
  • 8. VD 2007VD 2009 “How well it’s looking the day after..” R A O should be bannished R A O should be bannished
  • 10. CHAUR Pav. Ste Marie Trois Rivières SAVING Private radial MINIMIZING the AGGRESSION Puncture Related Catheters Related Compression Related VD Needle VD GC Shapes VD CRASOC Studies
  • 11. V Dangoisse et al, (Am J Cardiol 2017;120:374-379) 3616 TR Access
  • 12. Minimizing Injury Puncture Hemostasis Step (compression) Time of Compression Degree of Compression Catheters
  • 13. CRASOC I, II, III: METHODS The TR Band (Terumo ®) allows Selective radial artery compression and Precise control of Intensity + control of Duration Manufacturer instructions for defining the intensity of the compression are “empirical” (“inflate 13 to 18 cc of air”…) And the Manufacturer do not provide instructions for the duration of the compression…
  • 14. METHODS Controlling the VOLUME of AIR pushed in the TR-Band Allows a PRECISE CONTROL Over the INTENSITY of the external compression Controlling the TIME of PERMANENT INFLATION Allows a PRECISE CONTROL Over the DURATION of the external compression Controlling the TIME of PERMANENT INFLATION Allows a PRECISE CONTROL Over the DURATION of the external compression CRASOC I II III 13cc vs 10ccVolume 10cc 10cc Time 4h 3h vs 2h 2h vs 90’ (Glidesheaths 5+ 6) Random 1 / 2 1 / 1 3 / 1
  • 15. METHODS Randomization Method: BY WEEKS Random 1 week 10cc*/2h vs. Random 3 weeks 10cc*/11/2 h Crasoc III * (+ 2cc if bleeding at the time sheath’s removal) Selection of Patients: Included: all catheterized patients returning to the Cardiac Ward Excluded Patients: Missing Volume of air data (cath lab nurses) Missing 24h Nurse Evaluation Missing Doppler Evaluation Sent to another ward service Selection of Patients: Included: all catheterized patients returning to the Cardiac Ward Excluded Patients: Missing Volume of air data (cath lab nurses) Missing 24h Nurse Evaluation Missing Doppler Evaluation Sent to another ward service
  • 16. Right /L RA 5F/ 6F PCI / no pci Age F/M (%) Wrist diam. (cm) Weight (kg) Height (cm) BMI IIb/IIIa inh. Fluoro (sec) Dye (ml) DAP (Gy/cm2 ) Group (10cc/2h versus 10cc/11/2 h) METHODSDATA to be recorded/analyzed + N (cc) effectively used at the exit from the cath lab room Clin variablesClin variables Diabetes H B P Chol on R/ Family HxSmoking P V D Physical variables Physical variables Procedural variables Procedural variables RESULTS variables RESULTS variables RAO-Nurse (+ or - & if doubtful = (-)) RAO-Doppler (+ or - & if doubtful = (-)) Re-Bleeding/compression Events related to the vasc access RAO-Nurse (+ or - & if doubtful = (-)) RAO-Doppler (+ or - & if doubtful = (-)) Re-Bleeding/compression Events related to the vasc access Wrist diam. (cm)
  • 17. METHODS PRIMARY Endpoint: “RAO-Nurse” defined as Absence of Pulse and Oxygene Saturation When compressing the Ulnar artery with Plethysmography by the attending Nurse Secondary Endpoint: 1/“RAO-Doppler” performed when RAO-Nurse is present and defined as absence of a positive (anterograde) Doppler signal 2/ Re-Bleeding/compression after 2hr/11/2 h “secondary outcome”: any complication related to the arterial access site (see flow chart)
  • 18. RASOC I 13 vs.10cc - 4H________________________________________ Randomized Patients (1 for 2) in “NORMAL” (13 cc, as the minimum suggested by Terum LOW INTENSIT (10 c FOR 4 hours of permanent inflat CRASOC II 10cc-3H vs. 10 cc-2H__________________________ Randomized Patients (1 for 1) int “SHORT” COMPRESSION : 3 v “SHORTER” COMPRESSION : 2h WIT LOW INTENSITY (10 cc) of permanent inflatio + 2cc if immediate bleeding + 2cc if immediate bleeding 1937 Patients1937 Patients 942 Patients942 Patients
  • 19. CRASOC III 10cc 2 vs 11/2 h 5FS What is the BENEFIT OF further REDUCING THE DURATION (to 90 minutes) & What is the benefit of REDUCING THE SIZE OF THE SHEATH 5F to 5FS ** Crasoc I and II Ref:JACC-Cardiovasc interventions, feb 2016, 9;4,Ss crt-200.12 758 TRA758 TRA
  • 20. 2 cc removed TrBand removed Our working flow chart: Cardiology Ward
  • 21. Dedicated Database for TRA 1/ KT step: cathlab nurses/techn/Md Clin variablesClin variables Physical variables Physical variables id of the procedure
  • 22. 89% 8% 2% Figure 1 Volume of air (cc) needed to obtain hemostasis after TRA 1679 patients (Crasoc II & III) 559 179 506 435 499 161 389 446 CRASOCs studies 10 cc is far enough for the majority of Pts. V Dangoisse et al, (Am J Cardiol 2017;120:374e379) “Be Gentle” ResultsResults
  • 23. 2016 2009-11 2014 Glidesheath + 10 cc + 90 min ± 2,5% (3616 Patients) ± 10% RAO Nurse NNTH = 21 (we save 1 artery for 21 patients treated) V Dangoisse et al, (Am J Cardiol 2017;120:374e379) CRASOCs studiesResultsResults
  • 24. 4.2 % RAO Doppler 2016 2009-11 2014 Glidesheath + 10 cc + 90 min 0,26% NNTH = 34 (we save 1 artery for 34 patients treated) V Dangoisse et al, (Am J Cardiol 2017;120:374e379) (3616 Patients)CRASOCs studiesResultsResults
  • 25. The prize to pay… re-2cc re compr It’s easy to manage the problem V Dangoisse et al, (Am J Cardiol 2017;120:374e379)
  • 26. Duratio n Duratio n Intensit y (Vol cc) Intensit y (Vol cc) “Gentle & Short” compression “Patent"“Patent" 14% more RAO by + 1cc (> 10cc); 49% more RAO for 1h more compression time (> 2h)14% more RAO by + 1cc (> 10cc); 49% more RAO for 1h more compression time (> 2h) V Dangoisse et al, (Am J Cardiol 2017;120:374e379)
  • 27. O. R. Univariate O.R. Multivariate 95 % C.I. (Confidence Interval) Pvalue 13cc vs 10cc 1.16 1.16 [0.96 - 1.39] 0.113 3h vs 4h 0.8 0.84 [0.64 - 1.08] 0.185 2h vs 4h (crasoc II) 0.62 0.64 [0.46 - 0.85] 0.004 2h vs 4h (crasoc III) 0.65 0.69 [0.41 - 1.04] 0.116 1h30 vs 4h (crasoc III) 0.57 0.58 [0.42 - 0.78] 0.001 Height (+ 10 cm) 0.78 0.78 [0.66 - 0.91] 0.002 IIb.IIIa 1.45 1.62 [1.04 - 2.47] 0.03 Diabetes 0.92 0.72 [0.49 - 1.02] 0.071 Hypertension 1.55 1.78 [0.92 - 3.2] 0.066 PVD 2.15 1.56 [0.96 - 2.47] 0.063 Cholesterol 0.69 0.72 [0.47 - 1.07] 0.111 Table 3 Uni vs. Multivariate analysis (forward model), Odd Ratio for potential risk factors the patient height was the most predictive variable linked to the RAO (or the final patency) after TRA; for 10 cm above or below 169 cm, there was 22% less or more RAO nurse (9% to 34%, p 1 4 0.0022).⁄ V Dangoisse et al, (Am J Cardiol 2017;120:374e379) 169cm +/-
  • 28. “the patient’s height is possibly the best indicator of the patient’s radial artery size and the height largely outweighs all the other recorded physical variables, including the wrist diameter (measured for all cases). This makes sense: a larger vessel will resist more easily the catheterization-related trauma. Trying to relate all the clinical variables to their influence on the vessel size is tempting: for example, hypertension could induce a positive vessel remodeling and a larger artery with less RAO after TRA. Diabetes and peripheral vascular disease will lead to a negative remodeling, smaller vessels, and more RAO.” V Dangoisse et al, (Am J Cardiol 2017;120:374e379)
  • 29. …Trying to relate all the clinical variables to their influence on the vessel size is tempting: for example, hypertension may induce a positive vessel remodeling and a larger artery with less RAO after TRA. Diabetes and peripheral vascular disease will lead to a negative remodeling, smaller vessels, and more RAO.” V Dangoisse et al, (Am J Cardiol 2017;120:374e379)
  • 30. CHAUR Pav. Ste Marie Trois Rivières CAUTION Results of CRASOC Studies:
  • 31. …”optimizing the hemostasis step on top of using the recognized methods favoring the radial artery patency: liberal use of heparin use of hydrophilic sheaths reduction in the catheter size to 5F (including for PCI, performed in 5F for more than 80% of procedures in CRASOC I and II) and reduction in the sheath diameter (systematic use of GS Slender for the CRASOC III study) “ V Dangoisse et al, (Am J Cardiol 2017;120:374e379) These results are obtained…
  • 32. CHAUR Pav. Ste Marie Trois Rivières MINIMIZING the AGGRESSION Compression Related Keep it SOFT Keep it Short Be Gentle(man) Radial
  • 33. V Dangoisse CHAUR Pav. Ste Marie Trois Rivières GO TO AIM RADIAL 2017 10 cc (+ 2) 90’ then (-) 2 cc for 30-60’ -end- In Summary The Radial Artery will thank you