clinical implications of additional pedal artery angioplasty · clinical implications of additional...
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Clinical implications of additional pedal artery angioplasty
Tatsuya Nakama MD, Cardiovascular Center,
Miyazaki Medical Association Hospital,
Miyazaki, Japan
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For the 12 months preceding this CME activity
I disclose the following types of financial relationships:
•Honoraria received from:
Abbot Vascular, Asahi Intecc. Boston Scientific, Cook, Cordis, Kaneka, Medtronic, Otsuka, Orbus Neichi, Sanofi, Takeda, Terumo, Tokai Medical
• Consulted for: Abbot Vascular Japan, Boston Scientific Japan
•Held common stock in: None
• Research, clinical trial, or drug study funds received from: None
• I WILL NOTbe discussing products that are investigational or not labeled for use under discussion.
COI Disclosure
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What’s the optimal goal of
management of CLI
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Preventing the limbs loss?
Is it really enough?
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Even though the limbs loss is successfully prevented…
Incomplete wound healing
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Discrepancy of two outcomes
AFS@1year: 85.8%
WH@1year: 65.8% Limbs salvage rate: 86%
Wound healing rate: 66%
20% Discrepancy
From our single center database
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0
10
20
30
40
50
60
70
80
90
100
Limbs salvage
Wound healing
Discrepancy
EVT
Discrepancy of two outcomes
BSX
21% 20% 18% 19% 27% 10% 13% 8%
Iida et al, EJVES 43:313-321 (2012)
Kobayashi et al. CCI 85: 850-858 (2015)
Kawarada et al, CCI 80:861-871 (2012)
Azuma et al. EJEVS 43: 322-328 (2012)
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Complete wound healing
Next goal after the achievement of successful prevention of major amputation
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Predictors of delayed wound healing
Kawarada et al, CCI 80:861-871 (2012)
DM, Infection, Poor BTA
Shiraki et al, EJEVS 00:000-000 (2015)
Non-ambulatory, low Alb, R6 without heal, Infection,
Angiosome ID, Poor BTA
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Limbs salvage
Co-medical Foot care
Screening
Vascular surgeon Cardiovascular surgeon
Home doctor
General Physician
Orthopedic surgeon
Major amputation
dermatologist Skin care, Screening
Plastic surgeon
Multidisciplinary approach
Cardiologist
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Only one angiographic predictor pedal artery diseases
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1: Direct blood supply toward target wounds 2: Making run-off vessels for treated BTK arteries
Incomplete Pedal arch (Type 2a or 3 pedal)
Pedal arch angioplasty with 2.0mm balloon
complete Pedal arch (Type 1 pedal)
Challenging procedure = pedal artery angioplasty
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Result of pedal artery angioplasty
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Purpose
• The purpose of this study was
to evaluate the clinical implications of
pedal artery angioplasty
Nakama et al, J Endovasc Ther, 23:1 83-91 (2016)
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Additional pedal artery angioplasty (PAA)
PAA(+)group (n=14)
CLI attribute to infrainguinal and pedal artery disease (29 patients, 32 limbs)
Conventional above-the-ankle angioplasty
With sufficient wound blush (n = 18 limbs)
No additional procedure PAA(-) group (n=18)
With insufficient wound blush (n = 14 limbs)
Nakama et al, J Endovasc Ther, 23:1 83-91 (2016)
Study flow
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insufficient wound blush (WB) = indication of pedal angioplasty
Before PAA Type 3 After PAA: Type 1
Indication of pedal angioplasty
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Study outcomes
• Limb salvage rate (LS)
• Amputation free survival rate (AFS)
• Wound-healing rate (WH)
Time to wound-healing was also evaluated
Nakama et al, J Endovasc Ther, 23:1 83-91 (2016)
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Patients backgrounds Overall (n=29)
PAA(+) (n=14)
PAA(-) (n-15)
P value
Male sex, n (%) 21 (72) 11 (79) 10 (67) 0.383
Age, years 77.8 ± 8.6 77.0 ± 9.2 78.7 ± 8.1 0.970
No ambulatory status, n (%) 15 (52) 6 (43) 9 (60) 0.291
Body mass index, n (%) 21.1 ± 2.7 21.3 ± 2.4 20.9 ± 3.1 0.329
Hypertension, n (%) 22 (76) 11 (79) 11 (73) 0.542
Dyslipidemia, n (%) 8 (28) 5 (36) 3 (20) 0.298
Diabetes mellitus, n (%) 20 (69) 10 (71) 10 (67) 0.550
Smoking history, n (%) 13 (45) 6 (43) 7 (47) 0.607
Daily hemodialysis, n (%) 11 (38) 5 (36)
6 (40)
0.558
Albumin level, mg/dl 3.41 ± 0.50
3.49 ± 0.47
3.34 ± 0.53
0.681
LVEF, % 64.0 ± 10.1
65.7 ± 10.8 61.0 ± 9.6 0.277
Nakama et al, J Endovasc Ther, 23:1 83-91 (2016)
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Target Limb status Overall (n=32)
PAA(+) (n=14)
PAA(-) (n-18)
P value
Rutherford 6, n, (%) 8 (27) 3 (21) 5 (28) 0.504
Wound infection, n, (%) 10 (31) 4 (29) 6 (33) 0.541
CRP level, n, (%) 1.69 ± 2.63 1.10 ± 1.84 2.14 ± 3.08 0.109
Pure infrapopliteal lesion, n, (%) 16 (50) 10 (71) 6 (33) 0.037
Dorsal SPP before EVT, mmHg 22.7 ± 17.2 22.6 ± 12.9 22.8 ± 22.9 0.990
Plantar SPP before EVT, mmHg 23.2 ± 16.4 19.6 ± 12.9 28.1 ± 20.2 0.318
Dorsal SPP after EVT, mmHg 56.3 ± 15.1 60.7 ± 16.7 49.8 ± 10.3 0.144
Plantar SPP after EVT, mmHg 52.2 ± 17.7 60.2 ± 18.3 40.2 ± 6.9 0.025
Number of infrapopliteal run-off before EVT, n 0.63 ± 0.66
0.64 ± 0.75
0.61 ± 0.61
0.330
Number of infrapopliteal run-off after EVT, n 1.53 ± 0.62
1.64 ± 0.63
1.44 ± 0.62
0.706
Pedal artery before EVT, Type 2 / 3, n, (%) 15 / 17 (47 / 53)
3 / 11 (21 / 79)
12 / 6 (67 / 33)
0.038
Pedal artery after EVT, Type 1 / 2 / 3, n, (%) 7 /6 / 1 (50 / 43 / 7)
Nakama et al, J Endovasc Ther, 23:1 83-91 (2016)
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Limb salvage and AFS
Group 0M 3M 6M 9M 12M
PAA(+)
at risk 14 14 13 13 11
% 100 100 93 93 79
PAA(-) at risk 15 13 10 9 13
% 100 87 67 60 53
Group 0M 3M 6 M 9M 12M
PAA(+)
at risk 14 14 13 13 13
% 100 100 93 93 93
PAA(-) at risk 18 17 15 15 15
% 100 94 83 83 83
Limb salvage rate Amputation free survival rate
Nakama et al, J Endovasc Ther, 23:1 83-91 (2016)
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Wound-healing rate
Group 0 3 months 6 months 9 months 12 months
PAA(+) No. at risk 14 7 3 1 1
% 0 50 79 93 93
PAA(-) No. at risk 18 12 7 6 6
% 0 29 53 60 60
PAA(+): 86.0 ± 18.7 days (IQR: 63 ~ 155)
PAA(-): 152.0 ± 60.2 days (IQR: 80 ~ 365)
P=0.05
Time to wound-healing
Nakama et al, J Endovasc Ther, 23:1 83-91 (2016)
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Conclusion
An additional PAA may improve
wound healing rate and patients QOL
in patients with CLI
attributed to pedal artery diseases.
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Clinical implications of additional pedal artery angioplasty
Tatsuya Nakama MD, Cardiovascular Center,
Miyazaki Medical Association Hospital,
Miyazaki, Japan