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

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)

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