Clinical implications of additional pedal artery angioplasty · Clinical implications of additional...
Transcript of Clinical implications of additional pedal artery angioplasty · Clinical implications of additional...
Clinical implications of additional pedal artery angioplasty
Tatsuya Nakama MD, Cardiovascular Center,
Miyazaki Medical Association Hospital,
Miyazaki, Japan
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
What’s the optimal goal of
management of CLI
Preventing the limbs loss?
Is it really enough?
Even though the limbs loss is successfully prevented…
Incomplete wound healing
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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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)
Complete wound healing
Next goal after the achievement of successful prevention of major amputation
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
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
Only one angiographic predictor pedal artery diseases
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
Result of pedal artery angioplasty
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)
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
insufficient wound blush (WB) = indication of pedal angioplasty
Before PAA Type 3 After PAA: Type 1
Indication of pedal angioplasty
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)
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)
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)
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)
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)
Conclusion
An additional PAA may improve
wound healing rate and patients QOL
in patients with CLI
attributed to pedal artery diseases.
Clinical implications of additional pedal artery angioplasty
Tatsuya Nakama MD, Cardiovascular Center,
Miyazaki Medical Association Hospital,
Miyazaki, Japan