Presentazione a cura del Professor Angelo Cioppa - XII° Congresso Nazionale FIMeG 2018 - The Silver Tsunami: l'anziano fra appropriatezza e farmaeconomia

1. La rivascolarizzazione degli arti
inferiori nel paziente anziano:
rischi e vantaggi
Angelo Cioppa, MD
Division of Invasive Cardiology
"Montevergine" Clinic, Mercogliano - Italy

2. PAOD in the Elderly
6450 patients
Prevalence of PAOD by the Age
Incidence of Intermittent
Claudication
Framingham Heart
Study Cohort
Rotterdam Study

3. Lesion Location by the age Symptoms by the age Procedural Succees
LESIONS LOCATION – CLINICAL PRESENTATON – RESULTS
PAOD in the Elderly
<70 >70 <80 >80
7880
patients

4. COMPLICATIONS
ACCESS SITE
TRANSFUSION
CIN
P<0,001 >70 vs <70
No differences >70 vs >80
PAOD in the Elderly

5. COMPLICATIONS
PAOD in the Elderly
Overall 18,5% vs 8,5% p=0,010
Major 11,1% vs 1,8% p<0,001
Access site 12,5% vs 4,9% p=0,009
Bleeeding 12,5% vs 2,2% p<0,001
682 patients

6. ETA’ (ANNI)
Peripheral Interventions by the age (N=1115)
Montevergine 2014-2017

7. ETA’ (ANNI)
%
Perifepheral Intervention for PAOD by the age(%)
Montevergine 2014-2017

8. ETA’ (ANNI)
%
Perifepheral Intervention for PAOD by the age(%)
Montevergine 2014-2017

9. ETA’ (ANNI)
%
Perifepheral Intervention for PAOD by the age(%)
Montevergine 2014-2017

10. ETA’ (ANNI)
%
Clinical Presentation of PAOD by the age(%)
Montevergine 2014-2017

11. ETA’ (ANNI)
%
Clinical Presentation of PAOD by the age(%)
Montevergine 2014-2017

12. ETA’ (ANNI)
%
Clinical Presentation of PAOD by the age(%)
Montevergine 2014-2017

13. PAOD in the Elderly

14. PAOD in the Elderly
AAA prevalence increased
with age
>80 ys
PAOD prevalence 25%
PAOD without claudication 50%
ABI can be falsely elevated
(> 1,00) in diseaed elderly
due to arterial stiffness

15. Revascularization
PAOD in the Elderly
Optimal Management
Medical Therapy
Amputation
No differences
between adults
and elderly

16. PAOD in the Elderly
MEDICAL THERAPY
No differences
between adults
and elderly

17. PAOD in the Elderly
MEDICAL THERAPY
Strongly Recomended in the Elderly!!

18. Strongly
Recom
ended
in
the
Elderly!!
PAOD in the Elderly
MEDICAL THERAPY

19. PAOD in the Elderly
MEDICAL THERAPY
Strongly Recomended in the Elderly!!

22. PAOD in the elderly
• High incidence and prevalence
• Male = Female
• BTK > femoral > Iliac
• Multilevel disease> focal stenosisCritical
• Critical Ischemia > Intermittens Claudication
• More co-morbidities
• More complications
• Optimal medical therapy strongly
recomended
• Endovascular preferred to surgery

23. CHRONIC CRITICAL LIMB ISCHEMIA (CLI)
One of the most common and difficult
problem encounted by vascular
surgeons and endovascular
specialists, and incidence increase
with the aging of the population.

24. CHRONIC CRITICAL LIMB ISCHEMIA (CLI)
• CLI is the clinical manifestation of an end-stage
PAOD
• In CLI blood flow is so inadequate that rest pain,
ulcerations and/or gangrene occur.

25. PAD Claudicant vs CLIPAD Claudicant vs CLI
• 10-35% have
claudication at initial
presentation
• 5 years
• 15-30% deceased or expired
• 20% nonfatal cardiovascular event
Hirsch et al, Circulation, 2006;113:e463-654.
• 1-2% have CLI
at initial presentation
• 1 year
• 20% continuing CLI
• 25% resolved CLI
• 30% alive amputated
• 25% deceased or expired

26. The PAD prescription
(Olin JW et al. J Am Coll Card 2016)
The PAD prescription
(Olin JW et al. J Am Coll Card 2016)

27. 1. Arterial Disease
• anatomic distribution
• symptoms
2. Arterial Disease evaluation
(imaging)
3. Revascularization
• Clinical indication
• Technical choice
• Results according technical choice
Ischemic Foot with Arterial Disease

28. CRITICAL LIMB ISCHEMIA (CLI)
PRIMARY SITES OFPRIMARY SITES OF
INVOLVEMENTINVOLVEMENT
In CLI (Elderly)In CLI (Elderly)
Aorta & Iliac arteries: 30%
Femoral & Popliteal arteries: 40-50%
Tibial & Peroneal arteries: 50-60%
Combined ATK + BTK: 68%

29. Clinical Fontaine
stage
Rutherford
category
asymptomatic I 0
claudicatio
- mild
- moderate
- severe
IIa
IIb
IIb
1
2
3
rest pain (CLI) Stage III 4
ulceration or
gangrene (CLI)
- minor tissue loss
- major tissue loss
IV
5
6
Clinical Evaluation of PAOD
Clinical Fontaine
stage
Rutherford
category
PAOD with
neuropathy
asymptomatic I 0 X
claudicatio
- mild
- moderate
- severe
IIa
IIb
IIb
1
2
3
rest pain (CLI) Stage III 4
ulceration or gangrene
(CLI)
- minor tissue loss
- major tissue loss
IV
5
6
X
Elderly /BTK PAOD

30. 1. Arterial Disease
2. Arterial Disease + Neuropathy
3. Neuropathy
BTK Lesions

31. Ischemic Foot
PAOD evaluation
Limb revascularization
Limb salvage
Ability to walk
Treatment of trophic
lesions
Functional rehabilitation
Foot surgery
Treatment of trophic lesions
Adjuvant therapy
Treatment of trophic lesions
Ischemic Foot
Limb salvage and Ability to walk

32. 1. Macroangiopathy is most often seen in popliteal and tibial arteries
2. The lesions tend to be more extensive
3. Histopathological lesions
- Macroangiopathy
atherosclerosis
diffuse intimal fibrosis
medial calcific sclerosis
- Microangiopathy
no small artery or arteriolar occlusive lesion
4. Patency of the ankle and foot arteries LoGerfo FW
J Vasc Surg 1987; 5: 793-6
Elderly PAOD (+diabetes)

33. Elderly with BTK - PAOD
Foot Lesions
Etiology
• Ischemia
• Infection / Trauma

34. Ulceration and gangrene:
BTK PAOD + trauma

35. BTK - PAOD
+ gangrene/ulceration + infection

36. Incidence of CLI in controlateral limb
Follow up Holzenbein et al
J Vasc Surg 1996
Faglia et al
Diab Res and Clin Pract 2007
12 months 16% 17.9%
24 months 27.8% 28.8%
36 months 59.1% 34.4%
BTK - PAOD

37. R-R for all-cause mortality by DFU vs diabetes only
The association of ulceration of the foot with cardiovascular
and all-cause mortality in patients with BTK/Diabetes:
a Meta-Analysis Brownrigg JRW et al
Diabetologia 2012; 55: 2906-2912
BTK - PAOD

38. 1. Arterial Disease
• anatomic distribution
• symptoms
2. Arterial Disease evaluation (imaging)
3. Revascularization
• Clinical indication
• Technical choice
• Results according technical choice
Ischemic Foot with Arterial Disease

39. End-points
Imaging of femoro-popliteal-tibial axis
Imaging of foot arteries
• To define the presence of pathology
• To define the extension of pathology
• Run in, Run off (morphology and
haemodynamic aspects)
BTK - PAOD
Imaging

40. • Doppler CW, ABI
• Duplex
• TcPO2
• Angio MRI, Angio CT
• Angiography
BTK - PAOD
Imaging

41. BTK - PAOD
ABI

42. Artery Sensitivity (%) Specificity (%)
TPT 25-71 87-100
ATA 72-98 35-100
Peroneal a. 89-94 21-58
PTA 79-100 40-100
Dorsalis pedis 33-85 76-89
Plantar arteries 43-78 76-100
DUS assessment of tibial arteries in patients with arterial
disease: a Systematic Review
Bianchini Massoni C
BTK - PAOD
Imaging

43. Tibial arteries disease: Ultrasound evaluation
SFA
Popliteal A.
Anterior tibial A.
Dorsalis pedis A.
BTK - PAOD
Imaging

44. RUN OFFGOOD
RUN OFF
Tibial arteries disease in diabetic patients:
Can colour duplex mapping of the ankle and foot arteries improve the vascular
program?
M Gargiulo, A Stella, S Tarantini et al ESVS 2000
POOR
RUN OFF
BTK - PAOD
Imaging

45. Neuro-ischemic foot
Duplex ultrasound arterial mapping
from the EIA to the pedal arteries
Lower Extremity
Revascularization
Arteriography
Arterial wall calcification
Extensive ulcers
Edema
Very poor run in or run off
BTK - PAOD
Imaging

46. 1. Arterial Disease
• anatomic distribution
• symptoms
2. Arterial Disease evaluation (imaging)
3. Revascularization
• Clinical indication
• Technical choice
• Results according technical choice
Ischemic Foot with Arterial Disease

47. Clinical Fontaine
stage
Rutherford
category
Asymptomatic I 0
Claudicatio
- mild
- moderate
- severe
IIa
IIb
IIb
1
2
3
Rest pain Stage III 4
Ulceration or Gangrene
- minor tissue loss
- major tissue loss
Stage IV
5
6
C
L
I
Peripheral Arterial Occlusive Disease
(PAOD)
BTK
Revascularization

48. non-revascularized pts
BPG
PTA
Early and five year amputation and survival rate of diabetic patients
with critical limb ischemia: data of a Cohort study of 564 patients
Faglia E et al.
EJVES 2006; 32: 484-490
Above the ankle amputation
BTK
Revascularization

49. Long-term prognosis of Diabetic Patients with
Critical Limb Ischemia
Faglia E et al.l
Diabetes Care 2009; 32: 822-827
Survival
BPG - 114
PTA - 413
No REV - 27
Patients = 554
Mean follow up = 5.93 ± 1.28 years
BTK
Revascularization

50. GOALS of BTK PTA
• Clinical goals:
• Relief of ischemic rest pain
• Wound healing
• Avoidance of amputation
• Mobilization
• Improvement of survival
Primary goal
Re-establishment of
pulsatile, straight-line flow to the foot

51. BTK
Revascularization
Wound related artery concept
Christopher E. et Al. “Angiosomes of
the foot and ankle and clinical
implications for limb salvage”
”Plastic & ReconstructiveSurgery2006;117:
261s -293s
Acquiring direct flow based on the angiosome concept is
important in healing of the lesion and limb salvage
Ankle/Foot: 6 angiosomes
Posterior Tibial Artery (# 3)
. Calcanear artery
. Medial plantar artery
. Lateral plantar artery
Anterior Tibial Artery (#1)
. Dorsalis pedis artery
Peroneal Artery (#2)
. Calcanear artery
. Anterior perforating artery

52. BTK
Revascularization
“Willis like” foot circle
The first aim of PTA in CLI is to restore a direct blood flow to
the foot circle.
Treatment of foot arteries is essential in CLI patients
The lower leg
(tibialperoneal) vessels
usually connect in the foot
so that only one vessel is
usually necessary to be
open for foot
survival/salvage

53. Follow up 12
months
DR* IR
Wound healing 92% 73%
Limb salvage 93% 72%
* Direct revascularization of dorsalis pedis or plantar arteries
C. Varela et al
Vasc Endovascular Surg 2010 44(8) 654-660
The role of foot collateral vessels on ulcer healing and limb
salvage after successeful endovascular and surgical distal
procedures according to an angiosome model
Direct
Vs
Indirect
- Study: retrospective
- pts / legs: 70 /76
- revascularization: Endovascular 35
Bypass 41
BTK
Revascularization

54. Systematic Review and Meta-analysis of Direct versus Indirect
Angiosomal Revascularisation of infrapopliteal arteries
Bosanquet DC et al.
Eur J Vasc Endovasc Surg 2014; 48: 88-97
Limb Salvage
No of Studies
(total limbs)
Direct
(n)
Indirect
(n)
p
All studies 14 (1775) 991 784 <.0001
Endovascular revascularization 7 (1182) 672 510 .002
Bypass revascularization 6 (517) 274 243 .001
Larger studies 6 (1233) 686 547 .03
Propensity matched groups 3 (500) 250 250 .12
Newcastle-Ottawa 6 (948) 537 411 .06
1 year follow up 5 (663) 335 328 .08
BTK
Revascularization

55. BTK
Revascularization
Treament strategies in BTK
• Revascularisation First
►not infected ulcers
►dry gangrene
• Aggressive Surgical Debridment First
►infected foot
►wet gangrene

56. BTK
Revascularization
Therapeutic strategies
• The selection of the most appropriate
revascularization strategy has to be
determined on a case-by-case basis in a
specialized vascular centre in close
cooperation with an endovascular specialist
and a vascular surgeon.
• The main issues to be considered are the
anatomical suitability, co-morbidities, local
availability and expertise, and the patient’s
preference.

57. BTK
Revascularization
CLI Management
Revascularisation
Candidate?
No Yes
Medical therapy
Risk factors reduction
Local wound care
Antibiotics
Pain relief
Consider IPC
Surgery:
Younger, relatively fit
Amputation
Dimentia
Dialysis
Extensiv tissue loss
Impaired ambulation
Endovascular:
Older,more comorbidities

58. BTK
Revascularization
- Surgical treatment
- Endovascular treatment
- Hybrid treatment

59. BTK
Revascularization

60. BTK
Revascularization

61. BTK
Revascularization
Patency rates of by-pass grafting in
CLI/Severe limb ischemia
Procedure 5-Year
Patency
Aortobifemoral bypass 87(80-88)%
Axillounifemoral bypass 51(44-79)%
Axillobifemoral bypass 71(50-76)%
Femoropopliteal vein 69(60-82)%
Femoropopliteal ATK (Dacron) 49(46-53)%
Femoropopliteal ATK (PTFE) 38(32-45)%
Femoropopliteal below-knee 47%
Data adapted from TASC; Norgen L, Hiatt WR, Dormandy JA, et al. TASCII; J.Vasc. Surgery
2007; 45(Suppl S): S5-S67; S54A for pts. With CLI.

62. Chapter IV: Treatment of Critical Limb Ischaemia
Management of Critical Limb Ischaemia and Diabetic Foot.
Clinical Practice Guidelines of the European Society for
Vascular Surgery
Setacci C et al
ESVS 2011; 4 Suppl 2, S43–S59
Infrapopliteal Disease - Recommendations
- Endovascular treatment of infrapopliteal arteries has the potential to
achieve similar limb salvage rates with less procedural morbidity and
mortality than surgical bypass. Angioplasty as the first-line therapeutic
modality for patients with CLI and infrapopliteal lesion is reasonable
in the majority of cases, considering that the interventional procedure
should not preclude future surgical intervention. (Level 4; Grade C)
- Surgical treatment should be considered for more complex
anatomical lesions of BTK vessels or in case of endovascular failure
and persisting clinical symptoms of CLI. (Level 4; Grade C)
BTK
Revascularization

64. Introducer/approach
• 18- 20 G Needle
• 4F.
Introducer
Sheath

65. Below the Knee Balloon Angioplasty
BTK
Revascularization

66. BTK
Revascularization
BTK Endovascular Intervention Trials
Trial N (pts.) TVR Lim. S. Death F.U.(Y)
BTK chill 108 21 80 9 1
Chromis
deep(Cioppa)
50 NA 91 21 1
Boisiers
(Xpret)
94 42 91 29 2
Siabilis
(BMS)
41 30 80 29 3
Siabilis (SES) 62 23 82 32 3
Conrad 144 38 86,2 46 3,3
Das T, et al. J Endovasc Ther 2009; 16(Suppl II):II19-II30; Deloose K, et al. Eurointervention 2009;5:318-324;
Bosiers M, et al. Vascular 2009;1:1-8; Siablis D, et al. J Vasc Interv Radiol 2009;20:1141-1150;Contrad MF, et al. J
Vasc Surg 2009;50:799-805.

67. DEB in BTK: In. Pact

68. 12-m Major Adverse Events
* only patients with CLI
12-month Clinical Outcome
Patients n = 70 Lesions = 90
Twelve-Month Target Lesion Revascularization was 11%.
8 symptomatic (RC> 3) patients (10 lesions) referred to revascularization
(7 re-PTA and 1 Surgery) with Secondary Patency of 94%.
Limb Salvage in patients was 96% (3 Major Amputation)
15,0%
8,0%
77,0%
worse same better
12m vs. baseline
“Montevergine” DEB-BTK Registry

69. BTK Stent
BTK POBA
10
24
27
24
30
45
88
111
40
98
115
135
0
20
40
60
80
100
120
2005 2008 2010 2012
BTK totale
Tot 40 98 (60%) 115 (10%) 135(+30%) 145(+18%) 145 155
BMS 2/10 13/24# 17/27# 8/24 0/21 0/15 0/12
DES 8/10 11/24 10/27 16/24 21/21 15/15 12/12
DCB 0/30 0/45 48/88 80/111 100/121 110/130 135/155
2013
21
121
145
140
BTK PTAs at “Montevergine”
DCB
2014
145
130
15
2015
143
12
DCB155
135

70. The ongoing battle between infrapopliteal
angioplasty and bypass surgery for critical limb
ischemia
Schamp KBC et al
Ann Vasc Surg 2012; 26:1145-1153
……Angioplasty and surgery are clearly complementary and therapy
must be individualized by teams who are not vested in one theraphy or
the other. …….
Conte MD
Semin Vasc Surg 2012; 25:108-114
BTK
Revascularization
BTK revascularization:
endovascular versus open
bypass
Do we have the answer?

71. BTK Revascularization
Treatment of peripheral arterial disease in diabetes:
A consensus of the Italian Societies of Diabetes (SID,AMD), Radiology
(SIRM) and Vascular and Endovascular Surgery (SICVE)
Method of revascularization :
- the healing potential of the ulcer
- local condition of the foot
- vascular tree
- general condition of the patient
• Choice of revascularization technique
Aiello A et al.
Nutrition, Metabolism & Cardiovasc Disease 2014; 24: 355-369

72. Patency rates of by-pass grafting in
CLI/Severe limb ischemia
Is sustained patency necessary?
Wound Healing time ~ 6 M
Complete 6-month healing rate ~ 50%

73. 4 months
Periop.
10 months
4 days
10 months
Pre-op
Pre-op
Pre-op
15 days
24 days
9 months
BTK
Revascularization

74. Ischemic Diabetic Foot - Multidisciplinary Approach
- Family physician
- Nurses
- Diabetologist
- Nephrologist
- Emergency room physician
- Internal medicin physician
- Angiologist
- Geriatric physician
- Vascular Surgeon
- Interventional radiologist
- Cardiologist
- Orthopedic
- Plastic surgeon
- Podiatrist
- Anesthesiologist
- Physiatrist

75. - Conoscenza delle patologie associate
- Conoscenza della storia clinica del piede e del paziente
- Conoscenza della topografia della AOCP nell’ Anziano
- Accuratezza della diagnostica Ultrasonografica.
- Tecnica di Rivascolarizzazione in rapporto a differenti
variabili.
- Ruolo del lavoro in equipe
Prospettive nella gestione del paziente
Anziano con AOCP

76. THANK YOU!