1. Diabetic Foot Limb Salvage: A Singapore Experience
1st Congress of Diabetic Limb Salvage in Asia
Diabetic Foot Limb Salvage:
A Singapore Experience
Zhiwen Joseph LO, Zhimin LIN, Uei PUA, Lawrence QUEK, Bien Ping TAN, Sundeep PUNAMIYA
Glenn Wei Leong TAN, Sriram NARAYANAN, Sadhana CHANDRASEKAR
Thank you for the opportunity
GS, Ortho, VIR, Vasc lab colleagues
Zhimin & Rui Ming: data collection
Danson, Chet, ZK: literature r/v 1

2. Improved overall survival after 2 years in bypass group
, 27 UK hospitals
452 patients with severe leg ischaemia
Bypass-first vs Angioplasty first
An intention to treat analysis shows that out to 2 years both strategies were associated with similar amputation-free (AFS) and overall survival (OS) rates, as well as improvements in health-related quality of life.
In the short-term, BSX was significantly more morbid and expensive. However, for those patients who survived for 2 years after randomization, initial randomization to a BSX-first strategy was associated with a significant increase in subsequent OS of about 7 months and a non significant increase in subsequent AFS of about 6 months.
Patients were, of course, only eligible for BASIL if:
They required, were suitable(fit) for,and would give consent to immediate/early revascularization (about 50% of patients in the BASIL audit of top recruiting centers).
In the joint opinion of the responsible surgeon and interventionalist they could reasonably be treated by either a BSX-first or BAP-first strategy (about a third of that 50%, approximately 70% of whom were randomized, a high proportion by RCT standards)
So BASIL was likely to have excluded those patients with more:
Limited (proximal) disease who were suitable for BAP, where BSX was thought to be inappropriate; and
Extensive (distal) disease who were considered unsuitable for BAP and to be candidate for (often very) distal BSX.
Similar 2-year amputation-free and overall survival rates
Beyond 2 years, bypass was associated with a significant increase in overall survival of about 7 months
BASIL Trial JVS 2010 2

3. Multi-centre RCTs Vein bypass vs best endovascular treatment
VB first vs. Best Endovascular Treatment (BET) first, for the management of SLI due to infra-politeal disease, with or without the presence of femoro-politeal, disease.
BASIL-2 will recruit 600 patients with SLI from England,  Scotland and Northern Ireland, over 3 years. Patients will be followed up for an average of just over 3 years after their intervention.
There are 120 medical centers participating in this study. BEST-CLI expects to enroll 2,100 participants across the United States and Canada to be in this study.
Vein bypass vs best endovascular treatment
POBA vs DCB vs DES
CLI from infra-popliteal disease
patients over 3 years
Best surgical vs best endovascular therapy
PAD and CLI
2100 patients over 3 years 3

4. Meta-analysis 1-yr Limb Salvage 86% 1-yr Limb Salvage 88%
Bypass
29 articles (21 USA)
Inclusion: >15 PD grafts, survival analysis, f/u minimal 12mths
Ideal study quality score 15 (rate, life table, f/u, tissue loss, etc)
Median score 9 (range 3-12)
Angioplasty
30 articles from 1990 – 2006 (26 retrospective, 22 European)
Inclusion: >15 PTAs, CLI (rest pain / tissue loss), survival analysis, f/u minimal 12mths
Ideal study quality score 21 (study period, rate of crural intervention, symptoms, complications, life-tables, f/u, patency, limb salvage, etc)
Median study score 15 (5-18)
Primary patency at 1-yr:
Angio 58% whilst bypass 81%
Limb salvage at 1-yr:
Similar at 86-88%
Albers JVS 2006
Romiti JVS 2008 4

5. Japanese Data Endo: 1-yr AFS 79% 1-yr AFS 74% Bypass: 1-yr AFS 80%
Primary patency: fate of single PTA
Secondary patency: fate of initial and subsequent PTAs
(SVS/International Society for CV Surgery reporting standards for Endovasc procedures) – JVS 1993
Iida JACC 2015
Soga JEVT 2015 5

6. Diabetes in 25% of >60yo
Singapore Ministry of Health 2015

7. Study Design Retrospective Jan 2014 – Dec 2015
1,500-bed tertiary hospital
809 consecutive in-patient diabetic foot limb salvage
Angioplasty-first approach
Outcomes:
Length of stay
Limb salvage rate
Overall survival
Amputation free survival
Cost of in-patient stay
All in-patient tissue loss (incl Vasc, Ortho, Med)
Data drawn from discharge summary procedure with angioplasty 7

8. Baseline Characteristics Limb salvage attempts (n=809)
Demographics
Male : Female
Chinese : Malay : Indian
Mean age (range)
550 (68%) : 259 (32%)
477 (59%) : 113 (14%) : 219 (27%) 65 (52-80)
Co-morbidities
ASA 3 or 4
Smoker
Type 2 Diabetes Mellitus
Mean HbA1C (%) (range)
Hypertension
Hyperlipidaemia
Ischaemic heart disease
Previous stroke
End-stage renal failure
Previous amputation
736 (91%)
591 (73%)
809 (100%)
7.9 (5-12.4)
696 (86%)
477 (59%)
219 (27%)
186 (23%)
291 (36%)
Investigations
Anaemia
Hypo-albuminaemia
X-Ray osteomyelitis
404 (50%)
663 (82%) 8

9. Limb salvage attempts (n=809)
Vascularity
Limb salvage attempts (n=809)
Tissue loss on admission
Arterial ulcer
Dry gangrene
Wet gangrene
218 (27%)
226 (28%)
363 (45%)
Pre-intervention vascular studies
Toe pressures <50 mmHg
Infra-inguinal TASC A
Infra-inguinal TASC B
Infra-inguinal TASC C
Infra-inguinal TASC D
331 (41%)
73 (9%)
299 (37%)
TASC A
TASC B
TASC C
TASC D 9

10. Angioplasty Angioplasty (n=777) Superficial femoral artery
Patent native vessel
Re-vascularisation success / failure
253 (33%)
488 (63%) / 36 (4%)
Popliteal artery
247 (32%)
453 (58%) / 77 (10%)
Anterior tibial artery
71 (9%)
529 (68%) / 177 (23%)
Peroneal artery
106 (14%)
424 (55%) / 247 (31%)
Posterior tibial artery
141 (18%)
424 (55%) / 212 (27%)
Plantar arch
35 (5%)
140 (18%) / 602 (77%)
Use of adjuncts (DCB / stents)
4 (0.5%) 10

11. Reverse GSV Bypass (n=32)
Surgical Bypass
Reverse GSV Bypass (n=32)
Endarterectomy
8 (25%)
Femoral-popliteal bypass
11 (34%)
Femoral-distal bypass
16 (50%)
Popliteal distal bypass
5 (16%)
20 (63%) as salvage procedure to failed angioplasty 11

12. Outcomes Angioplasty (n=777) Bypass (n=32) p value (Fisher’s χ2)
Average LOS (days)
12.3 (1-91)
48.4 (6-168)
<0.001*
Successful limb salvage
684 (88%)
23 (72%)
0.013
Overall survival
724 (93%)
28 (88%)
0.274
Amputation-free survival
582 (75%)
22 (69%)
0.413
Average in-patient cost (S$) (range)
5,518 (841-17,329)
15,141 (3,221-28,070)
* Student t-test 12

13. Angioplasty (n=777) Limb Salvage Success (n=684) Limb Salvage Failure
Univariate Analysis p value
Multivariate analysis OR (SD) p value
Demographics
Male
Mean age
410 (60%) 64
51 (55%) 68
- -
Co-morbidities
ASA 3 or 4
End-stage renal failure
Previous amputation
561 (85%) 68 (10%) 205 (30%)
86 (93%) 36 (39%) 39 (41%)
1.45 (0.47) ; p= (0.33) ; p= (0.52) ; p=0.11
Tissue loss on admission
Arterial ulcer
Dry gangrene
Wet gangrene
171 (28%) 164 (24%) 267 (39%)
31 (33%) 26 (28%) 43 (46%)
1.42 (0.48) ; p=
Vascular Studies
Toe pressures <50 mmHg
Infra-inguinal TASC C / D
205 (30%) 144 (21%)
46 (49%) 34 (37%)
2.15 (0.39) ; p= (0.22) ; p=0.03
Post-angioplasty crural flow
Only single vessel flow
178 (26%)
39 (42%)
0.002
2.03 (0.32) ; p=0.02 13

14. Conclusions Within our study population:
Majority of patients (91%) had multiple co-morbidities and were poor surgical candidates, hence were considered for angioplasty-first re-vascularisation
Surgical bypasses were performed mainly (63%) as salvage procedures for failed angioplasties
At 1-year, for patients who underwent angioplasty, successful limb salvage was 88%, overall survival was 93% and amputation-free survival was 75%
Independent predictors for limb salvage failure for patients who underwent angioplasties were end-stage renal failure, toe pressures < 50mmHg, TASC C/D pattern and single-vessel crural flow post-angioplasty. 14

15. 1st Congress of Diabetic Limb Salvage in Asia
Thank you
Zhiwen Joseph LO, Zhimin LIN, Uei PUA, Lawrence QUEK, Bien Ping TAN, Sundeep PUNAMIYA
Glenn Wei Leong TAN, Sriram NARAYANAN, Sadhana CHANDRASEKAR
Thank you for the opportunity
GS, Ortho, VIR, Vasc lab colleagues
Zhimin & Rui Ming: data collection
Danson, Chet, ZK: literature r/v 15

17. Hinchliffe et al. 2012 New systematic r/v of 49 papers
Bypass 1yr limb salvage 85%
Angioplasty 1yr limb salvage 78%
Overall ulcer healing 60%
Hinchliffe et al. 2012 17