Bleeding avoidance strategies, such as a transradial approach (TRA), should be considered especially for patients with high bleeding risk.3) However, PCI operators hesitate to choose conventional TRA for patients on dialysis because of the increased risk of radial artery occlusion (RAO) and general tendency to preserve possible hemodialysis access points for the future.

1. A Trans-Radial Approach
of Cardiac Catheterization
for Patients on Dialysis
Department of Cardiology
Japanese Red Cross Ashikaga
Toshiki Kuno, MD, PhD,a,b Keita Hirano, MD,c Takayuki Abe, PhD,d Syohei
Imaeda, MD,a Kenji Hashimoto, MD,a, Toshinobu Ryuzaki, MD,a, Souichi
Yokokura, MD,a Tetsuya Saito,a, Hiroyuki Yamazaki, MD,a, Ryota Tabei, MD,a
Masaki Kodaira, MD, PhD,a Yohei Numasawa, MD, PhDa
aDepartment of Cardiology, Japanese Red Cross Ashikaga Hospital, Ashikaga, Japan
bDepartment of Medicine, Mount Sinai Beth Israel Medical Center, New York, USA
aDepartment of Nephrology, Japanese Red Cross Ashikaga Hospital, Ashikaga,
Japan
dDepartment of Preventive Medicine and Public Health, Biostatistics at Center for
Clinical Research, Keio University School of Medicine, Tokyo, Japan

2. Department of Cardiology
Japanese Red Cross Ashikaga
Kuno et al. J Invasive Cardiol. 2018 Jun; 30 (6): 212-217

3. Case
83 F, 145cm, 40kg, BMI:19
DM, HT, ESRD on Dialysis
Prolonged chest pain (30min.)
ECG: TWI in precordial lead
FA both palpable, but very hard
Conventionally, diagnostic catheter through FA
performed, then, PCI if necessary with large size sheath
However, periprocedural puncture site bleeding risk is
extremely high
Department of Cardiology
Japanese Red Cross Ashikaga

4. Background
Periprocedural bleeding is the most common complication of PCI,
and associated with an increase risk of early and late mortality1)
Bleeding risk is high for patients on dialysis2)
Department of Cardiology
Japanese Red Cross Ashikaga
Bleeding avoidance strategies, such as a
transradial approach (TRA), should be considered
especially for patients with high bleeding risk.3)
However, PCI operators hesitate to choose
conventional TRA for patients on dialysis because
of the increased risk of radial artery occlusion
(RAO) and general tendency to preserve possible
hemodialysis access points for the future.
1): Karrowni et al. JACC Cardiovas Interv 2013;6:814-82
2): Numasawa et. al. PLoS One 2015;10:e0124399.
3): Numasawa et. al. Cardiovasc Interv Ther 2013 28:14

5. Background
Previous studies demonstrated that
2-year primary and secondary
patency rates of arteriovenous fistula
(AVF) were 51% and 64% 1)
Generally, RAO rates were 1%-10% 2)
Preservation of possible hemodialysis
access points for the future is
questionable because 5-year survival
rate of patients on dialysis is poor
(approximately 50%) 3)
1): Ahmed et. al. Am J Kid Dis 63 (3):464-78
2): Mamas et. al. Eurointervention 2014;10:824-83
3): Marui et. al. Am J Cardiol 2014;114:555-561.
Department of Cardiology
Japanese Red Cross Ashikaga

6. Hypothesis and aims
We considered that TRA would be beneficial for patients on
dialysis despite the risk of RAO, because it can reduce
bleeding complications and early mortality rates.
The aims of this study were to construct a TRA system and
to clarify the feasibility of TRA for patients on dialysis.
O
R
Department of Cardiology
Japanese Red Cross Ashikaga

7. Method -study protocol-
This study was an ongoing, prospective, cohort study
Data of 88 consecutive patients on dialysis who underwent
cardiac catheterization (diagnostic angiography [DA] or PCI)
between December 2015 and December 2016 were analyzed
The institutional review board and nephrologist approved the
study design
Informed consent was obtained for all patients
Radial access was limited in the opposite side of AVF
P2Y12 inhibitor was restricted to clopidogrel
Department of Cardiology
Japanese Red Cross Ashikaga

8. Exclusion Criteria of TRA
Patients who did not agree the consent
Patients with weak or absent radial artery pulse
Patients on peritoneal dialysis with weak or absent radial
artery pulse on one side in order to preserve the other side
for future access
Recent AVF failure (within 6 months)
Trans femoral approach (TFA) preferred by operator (eg, for 8
Fr)
Nephrologist decision against TRA
Department of Cardiology
Japanese Red Cross Ashikaga

9. Assigned to TFA due to
Patients’ decline: 2
Weak or absent radial artery pulse: 10
Recent AVF failure: 4
Use of 8Fr: 1
Operators’ decision including
subclavian artery tortuosity: 7
Post bilateral AVF operation: 1
(a nephrologist’s decision)
History of radial artery injury: 1
(a nephrologist’s decision)
88 consecutive patients on dialysis who underwent
cardiac catheterization from 2015 Dec. to 2016 Dec.
TRA group
N=62 (70.5%)
TFA group
N=26 (29.5%)

10. TRA –study protocol–
Glidesheath Slender® (Terumo) which showed lower rates of RAO was
used for more than 6Fr1)
Radial artery diameter is measured
Bleedsafe® (Medikit) is used to hemostasis (DA 5 hours, PCI 7
hours)
Patent hemostasis2) which could decrease RAO, was attempted
Bleedsafe® was inflated for sheath removal. After removal, ulnar
artery was pressed
Pulse oximetor was placed to the index finger. If plethysmographic
signal returned, radial artery patency was confirmed.
If not, deflate 1cc each, with caution. If bleeding occurs, inflate again.Department of Cardiology
Japanese Red Cross Ashikaga
1): Mehran et. al. Circulation 2011;123:2736-2747.
2): Pancholy et. al. Catheter Cardiovasc Interv 2008;72:335

11. Results

12. Baseline Characteristics
TRA group
% (N=62)
TFA group
% (N=26)
P value
Age (years) 71 [65, 80] 65 [62, 75] 0.050
Female 29.0% (18) 30.8% (8) 0.871
Hypertension 80.6% (50) 80.8% (21) 0.989
Diabetes mellitus 53.2% (33) 73.1% (19) 0.084
Diabetes mellitus with insulin 19.4% (12) 30.8 % (8) 0.244
Cerebral infarction 9.7% (6) 3.8% (1) 0.356
Peripheral artery disease 14.5% (9) 19.2% (5) 0.581
Hemodialysis 82.2% (51) 100% (26) 0.022
Peritoneal dialysis 17.7% (11) 3.8% (1) 0.083
Previous MI 11.2% (7) 15.4% (4) 0.596
Previous HF 19.4% (12) 38.5% (10) 0.059
Previous PCI 21.0% (13) 46.2% (12) 0.017
Department of Cardiology
Japanese Red Cross Ashikaga

13. Baseline Characteristics
TRA group
% (N=62)
TFA group
% (N=26)
P value
Catheterization indications
ST-elevation MI
Non ST-elevation MI
Unstable angina
Effort angina
Silent ischemia
Others
0.0% (0)
4.8% (3)
8.1% (5)
24.2% (15)
56.5% (35)
6.5% (4)
3.8% (1)
3.8% (1)
23.1% (6)
42.3% (11)
26.9% (7)
0.0% (0)
0.025
Left main trunk stenosis 4.8% (3) 3.8% (1) 0.838
3-vessel disease 17.7% (11) 34.6% (9) 0.085
Preprocedural aspirin 61.3% (38) 88.5% (23) 0.012
Preprocedural thienopyridine 38.7% (24) 73.1% (19) 0.003
Preprocedural warfarin 3.2% (2) 7.7% (2) 0.359
Radial artery diameter (mm) 2.5±0.5 -
Department of Cardiology
Japanese Red Cross Ashikaga

14. Procedural data
TRA group
% (N=62)
TFA group
% (N=26)
P value
Arterial sheath size
4Fr
5Fr
6Fr
7Fr
8Fr
12.9% (8)
1.6% (1)
71.0% (44)
14.5% (9)
0.0% (0)
11.5% (3)
3.8% (1)
34.6% (9)
42.3% (11)
7.7% (2)
0.004
Glidesheath Slender® 83.9% (52) -
PCI
Procedural information
Intra aortic balloon pump
Drug eluting stent
Rotational atherectomy
38.7% (24)
4.1% (1)
87.5% (21)
16.7% (4)
73.1% (19)
0.0% (0)
63.2% (12)
47.4% (9)
0.003
0.368
0.060
0.029
Department of Cardiology
Japanese Red Cross Ashikaga

15. Procedural data
TRA group
% (N=62)
TFA group
% (N=26)
P
value
Patent hemostasis 62.3% (33) -
Radial artery spasm 1.6%(1) -
Severe arterial
tortuosity affecting
catheterization
manipulation
6.5% (4) 3.8% (1) 0.630
Procedural success 98.4% (61) 100% (26) 0.515
Radial artery occlusion
(24 hours/30 days)
6.5% (4)/6.5% (4) -
Department of Cardiology
Japanese Red Cross Ashikaga
Of patients with RAO, 2 patients underwent PCI with 7 Fr Glidesheath
Slender and radial artery diameters were 2.1 mm and 3.3 mm. In the other 2
patients, 6 Fr Glidesheath Slender was inserted for DA and radial artery
diameters were 1.5 mm and 2.2 mm.

16. Patients’ outcomes
TRA group
% (N=62)
TFA group
% (N=26)
P value
Puncture site bleeding 0.0% (0) 3.8% (1) 0.120
Puncture site hematoma 1.6% (1) 0.0% (0) 0.515
Hand ischemia 0.0% (0) -
Pseudo-aneurysm 0.0% (0) 3.8% (1) 0.120
Puncture site related
intervention/surgery
0.0% (0) 3.8% (1) 0.120
Transfusion 0.0% (0) 3.8% (1) 0.120
In-hospital mortality/30-day
mortality
0.0% (0)
/0.0% (0)
0.0% (0)
/0.0% (0)
1): Mehran et. al. Circulation 2011;123:2736-2747.
Puncture site bleeding: hemoglobin drop >3.0 g/dL; need for transfusion;
procedural intervention/surgery 1)
Puncture site hematoma: for TFA:>10cm, for TRA:>2cm

17. Discussion
It is well known that patients on dialysis have high bleeding risk for
PCI 1)
The advantages of TRA are patients’ comfort, decrease bleeding
risk, and improve patients’ outcomes2,3)
The current American Heart Association statement includes a class
III recommendation for the routine use of vascular closure devices
(VCD) to reduce the incidence of vascular complications 4)
And our previous study did not reveal decrease of bleeding events5)
In our study, we did not reveal major endpoints such as puncture
site bleeding due to limited number of patients
Department of Cardiology
Japanese Red Cross Ashikaga
1): Numasawa et. al. PLoS One 2015;10:e0124399.
2): Numasawa et. al. Cardiovasc Interv Ther 2013 28:148
3): Karrowni et al. JACC Cardiovas Interv 2013;6:814-823
4): Patel et. al. Circulation 2011;123:2736-2747.
5): Kuno et. al. AsiaIntervention 2017;3:70-80.

19. Discussion
In our study, the rate of RAO was 6.5%, which was relatively high,
but within the range of previous studies
Patent hemostasis was not effective in our study
Downsizing sheath is considered to be effective according to the
vessel size1)
The long compression time could be one of the reasons behind
RAO in the current study 2)
Ulnar compression to recanalize RAO after band removal could be
effective3)
Department of Cardiology
Japanese Red Cross Ashikaga
1): Mamas et. al. Eurointervention 2014;10:824-832.
2): Pancholy et. al. Catheter Cardiovasc Interv 2012;79:78
3): Bernat et. al. Am J Cardiol 2011;107:1698-701.

20. Future Perspective
Multicenter Randomized Trial, if possible
Distal radial puncture for patients on dialysis should be
tried
Department of Cardiology
Japanese Red Cross Ashikaga

21. Case
Discuss the benefit and the risk of TRA with Patients
Angiography showed LAD proximal 99% with Calcification
PCI performed with 7Fr Glidesheath® (Rotablator and stenting)
No complications such as bleeding and RAO

22. Which do you prefer, TRA or TFA,
for patients on dialysis?
OR
Department of Cardiology
Japanese Red Cross Ashikaga

23. Conclusion
We constructed the system of TRA for
patients on dialysis
Department of Cardiology
Japanese Red Cross Ashikaga

24. Thank you for your attention
Questions?
Toshiki.Kuno@mountsinai.org
kuno-toshiki@hotmail.co.jp
Department of Cardiology
Japanese Red Cross Ashikaga

25. Radial artery occlusion (RAO)
–definition–A pulse-oximeter sensor was placed over the index finger. Radial
and ulnar arteries were compressed; subsequently, the radial
artery was released.
When plethysmographic signal returned, radial artery patency was
confirmed.
This test was performed on the next day after the procedure. If
RAO was suspected, ultrasonography with duplex Doppler was
performed to observe the absence of blood flow, after which RAO
was confirmed.
These patients were examined at 30 days post procedure because
RAO rates at 30 days were reportedly lower than those detected
at 24 hours 1)
1): Pancholy et. al. Catheter Cardiovasc Interv 2008;72:335
Department of Cardiology
Japanese Red Cross Ashikaga

26. Baseline Characteristics
TRA group
% (N=62)
TFA group
% (N=26)
P value
Age (years) 71 [65, 80] 65 [62, 75] 0.050
Female 29.0% (18) 30.8% (8) 0.871
Hypertension 80.6% (50) 80.8% (21) 0.989
Smoking 30.6% (19) 34.6% (9) 0.715
Dyslipidemia 38.7% (24) 34.6% (9) 0.717
Diabetes mellitus 53.2% (33) 73.1% (19) 0.084
Diabetes mellitus with insulin 19.4% (12) 30.8 % (8) 0.244
Cerebral infarction 9.7% (6) 3.8% (1) 0.356
Intracranial Hemorrahage 6.5% (4) 3.8% (1) 0.63
Peripheral artery disease 14.5% (9) 19.2% (5) 0.581
Hemodialysis 82.2% (51) 100% (26) 0.022
Peritoneal dialysis 17.7% (11) 3.8% (1) 0.083
Baseline hemoglobin (g/dl) 10.2 [9.6, 10.8] 10.8 [9.4, 11.7] 0.253
Previous MI 11.2% (7) 15.4% (4) 0.596
Previous HF 19.4% (12) 38.5% (10) 0.059
Previous PCI 21.0% (13) 46.2% (12) 0.017
Previous coronary bypass 0.0% (0) 3.8% (1) 0.120
Atrial fibrillation 6.5% (4) 11.5% (3) 0.421

27. Baseline Characteristics
TRA group
% (N=62)
TFA group
% (N=26)
P value
Catheterization indications
ST-elevation MI
Non ST-elevation MI
Unstable angina
Effort angina
Silent ischemia
Others
0.0% (0)
4.8% (3)
8.1% (5)
24.2% (15)
56.5% (35)
6.5% (4)
3.8% (1)
3.8% (1)
23.1% (6)
42.3% (11)
26.9% (7)
0.0% (0)
0.025
Left main trunk stenosis 4.8% (3) 3.8% (1) 0.838
2-vessel disease 32.3% (20) 19.2% (5) 0.216
3-vessel disease 17.7% (11) 34.6% (9) 0.085
Preprocedural aspirin 61.3% (38) 88.5% (23) 0.012
Preprocedural thienopyridine 38.7% (24) 73.1% (19) 0.003
Preprocedural warfarin 3.2% (2) 7.7% (2) 0.359
Radial artery diameter (mm) 2.5±0.5 -

28. Procedural data
TRA group
% (N=62)
TFA group
% (N=26)
P value
Arterial sheath size
4Fr
5Fr
6Fr
7Fr
8Fr
12.9% (8)
1.6% (1)
71.0% (44)
14.5% (9)
0.0% (0)
11.5% (3)
3.8% (1)
34.6% (9)
42.3% (11)
7.7% (2)
0.004
Glidesheath Slender® 83.9% (52) -
Femoral vein sheath insertion 9.7% (6) 34.6% (9) 0.005
PCI
Procedural information
Intra aortic balloon pump
Drug eluting stent
Bare metal stent
Drug coated balloon
Balloon angioplasty
Intravascular ultrasound
Rotational atherectomy
38.7% (24)
4.1% (1)
87.5% (21)
0.0% (0)
12.5% (3)
4.2% (1)
95.8% (23)
16.7% (4)
73.1% (19)
0.0% (0)
63.2% (12)
0.0% (0)
5.3% (1)
36.8% (7)
89.5% (17)
47.4% (9)
0.003
0.368
0.060
0.417
0.865
0.416
0.029
Hemoglobin change after a
procedure (g/dl)
-0.2 [-0.6, 0.5] -0.45 [-1.2, 0.0] 0.043
Closure device - 11.5% (3)

29. Procedural data
TRA group
% (N=62)
TFA group
% (N=26)
P
value
Patent hemostasis 62.3% (33) -
Radial artery spasm 1.6%(1) -
Severe arterial tortuosity
affecting catheterization
manipulation
6.5% (4) 3.8% (1) 0.630
Procedural success 98.4% (61) 100% (26) 0.515
Radial artery occlusion
(24 hours/30 days)
6.5% (4)
/6.5% (4)
-

30. Patients’ outcomes
TRA group
% (N=62)
TFA group
% (N=26)
P value
Puncture site bleeding 0.0% (0) 3.8% (1) 0.120
Puncture site hematoma 1.6% (1) 0.0% (0) 0.515
Peritoneal bleeding - 0.0% (0)
Hand ischemia 0.0% (0) -
Prolonged hospital stay due to re-bleeding 0.0% (0) 3.8% (1) 0.120
Pseudo-aneurysm 0.0% (0) 3.8% (1) 0.120
Puncture site related intervention/surgery 0.0% (0) 3.8% (1) 0.120
Transfusion 0.0% (0) 3.8% (1) 0.120
In-hospital mortality/30-day mortality 0.0% (0)/0.0% (0) 0.0% (0)/0.0% (0)
Other complications
PCI related MI
Post PCI CS
Post PCI HF
Coronary perforation
Coronary dissection
Cardiac tamponade
Cerebral infarction
Intracranial hemorrhage
Gastrointestinal bleeding
Genitourinary bleeding
Other bleedings
3.2% (2)
0.0% (0)
0.0% (0)
0.0% (0)
0.0% (0)
0.0% (0)
1.6% (1)
0.0% (0)
0.0% (0)
0.0% (0)
0.0% (0)
0.0% (0)
3.8% (1)
0.0% (0)
0.0% (0)
0.0% (0)
0.0% (0)
3.8% (1)
0.0% (0)
3.8% (1)
0.0% (0)
0.0% (0)
0.354
0.106
0.481
0.106

31. Study endpoints
In-hospital and 30-day mortality rates
Puncture site related bleeding complications
hemoglobin drop >3.0 g/dL; need for transfusion; procedural
intervention/surgery at the bleeding site to reverse/stop or
correct the bleeding; and acute anemia with a reduction in
hemoglobin > 3.0 g/dL without other obvious sources or
intraprocedural blood loss.
Puncture site hematoma (for TFA:>10cm, for TRA:>2cm)
Safety endpoint in TRA group: Procedural success rate
and RAO
Department of Cardiology
Japanese Red Cross Ashikaga 1): Mehran et. al. Circulation 2011;123:2736-2747.

32. Fluoroscopy time
/Contrast volume
TRA group
(N=62)
TFA group
(N=26)
P value
Fluoroscopy time
(min)
8.0 [3.6, 16.5] 15.5 [9.8, 27.1] 0.003
Contrast volume
(ml)
78.5 [63, 169] 132 [79.9, 132] 0.018
Department of Cardiology
Japanese Red Cross Ashikaga
TRA group PCI
% (N=24)
TFA group PCI
% (N=19)
P value
Fluoroscopy time
(min)
17.4 [14.2, 21.9] 22.5 [14.5, 33.1] 0.35
Contrast volume
(ml)
174 [139, 201] 132 [123, 229] 0.84

33. Missing baseline information
(preprocedural creatinine, sex, and
age) N=1138
eGFR>30ml/min./1.73m2 N=2138
Trans-brachial PCI N=4
Use of percutaneous cardiopulmonary
support N=2
Bidirectional approach for CTO N=8
Consecutive 3596 patients who underwent PCI
from 2009 Sep. to 2017 Dec.
TRI group
N=114 (37.3%)
TFI group
N=192 (62.7%)

34. Department of Cardiology
Japanese Red Cross Ashikaga
Bleeding
complications
and in-hospital death
Bleeding
complications
In-hospital
mortality
IPTW
analysis
OR (95% CI)
0.19
(0.06-0.62)
P=0.006
0.20
(0.04-1.98)
P=0.064
0.12
(0.03-0.59)
P=0.009
IPTW
(PS 0.1-0.9)
OR (95% CI)
0.21
(0.06-0.73)
P=0.014
0.19
(0.03-1.06)
P=0.058
0.16
(0.03-0.92)
P=0.040

35. • For the sensitivity analysis, we excluded patients with
intra-aortic balloon pump (N = 32, 10.4%). In this
population (N = 274, 89.5%), TRI had a tendency to
be a favorable predictor for a lower primary endpoint
(OR: 0.12; 95% CI: 0.01–1.01; P = 0.051).
• RAO among ESRD on dialysis was confirmed at both
24 hours and 30 days after the procedure in 3
patients (9.1%). All 3 patients had no symptoms of
radial artery occlusion; 7-Fr arterial sheaths were
inserted in 2 out of 3 patients and a 6-Fr arterial
sheath was inserted in 1 patient.

37. Department of Cardiology
Japanese Red Cross Ashikaga

38. 橈骨動脈閉塞は4人。
2人は7Fr Glidesheath でのPCI。橈骨動脈径は
2.1/3.3mmであった。2人は6Fr Glidesheathでの造影検
査であり、橈骨動脈径は1.5/2.2mmであった
3人にPatent hemostasisはおこなった。
全員橈骨動脈閉塞による症状を認めなかった。

39. 本研究の橈骨動脈閉塞は6.5%と今までの研究結果とそこまで
変わらない。
ただPatent hemostasisもさほど効果はなかった。
血管径に合わせたシースサイズダウンが有効ではないかと考
えられる。1) 5Frのガイドや6.5Frのシースレスガイドが有用かも
しれない。ただRotablatorの高い使用率がラージサイズのシー
スを要している一因である。
圧迫時間が長いのも橈骨動脈閉塞に影響を及ぼしていると考
えられる。2)
また橈骨動脈閉塞になった患者に対して尺骨動脈を圧迫する
ことで橈骨動脈を開存させる方法が報告されており、施行すべ
きであった。3)

40. Patent hemostasis
まずBleedsafe®を15ccで加圧しシースを抜去する。
人差し指にSpO2モニターを装着する。
その状態で尺骨動脈のBleedsafe®の末梢を圧迫する。
SpO2モニターの波形があればPatent hemostasisの達成。1)
波形がない場合は徐々に緩めていき波形が出現するまで
緩める。波形が出現し、かつ止血されていればPatent
hemostasisの達成。
その間に出血するようであれば加圧する。(Patent
hemostasis非達成。)
1): Pancholy et. al. Catheter Cardiovasc Interv 2008;72:335
Department of Cardiology
Japanese Red Cross Ashikaga