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AimRadial
2015
Angioplasty of the hand arteries
in critical hand ischaemia
Zoltán Ruzsa, Imre Ungi, Balázs Nemes, Júlia Tóth,
András Katona, Kálmán Hüttl, Béla Merkely
Disclosure Statement of Financial Interest
I, Zoltán Ruzsa MD. PhD. DO NOT have a
financial interest/arrangement or affiliation with
one or more organizations that could be
perceived as a real or apparent conflict of
interest in the context of the subject of this
presentation.
Background
Critical hand ischaemia (CHI) of the upper extremity is rarely
encountered. Axillary, brachial and below-the-elbow (BTE) disease is
often asymptomatic due to highly developed collaterals, but in diffuse-
multiple and thrombotic disease CHI can develop.
There are only case reports1,2 and limited number of studies 3,4 of the
angioplasty in critical hand ischemia.
The aim of this prospective study was to assess the feasibility, safety and
outcomes of percutaneous transluminal angioplasty (PTA) in the
treatment of CHI.
1. Ruzsa. Cardiovasc Revasc Med. 2010 Oct-Dec;11(4):266.e1-4.
2. Rademakers LM. Neth Heart J. 2012 Sep;20(9):372-5.
3. Kawarada O. Catheter Cardiovasc Interv. 2010 Sep 1;76(3):345-50.
4. Gandini R. J Vasc Surg. 2010 Mar;51(3):760-2.
Anatomical
background
• Anatomy of the upper extremity
– Inflow arteries
• Brachiocephalic and subclavian artery
– Intrinsic arteries
• Axillary, brachial, radial, ulnar, palmar and digital arteries
• Deep and superfitial palmar arch
• Anomalous circulation
– The paralell arterial systems of upper extremity allow to maintain the normal
perfusion at rest even in the setting of a significant stenosis
• Collateral pathways
– Shoulder and elbow collaterals
• Ad. 1 Subclavian occlusion – vertebral collaterals
• Ad 2. Brachial occlusion- collateralis from the distal to proximal arm
• Ad. 3 Radial or ulnar occlusion- collateralis from the interosseal or palmar
arch
Pathophysiology of CHI
Macrovascular disease Microvascular disease
Patient with ulnar artery
occlusion
Patient with renal failure, on
haemodialysis
Anatomical background
Ulnar artery occlusion Ulnar artery occlusion
Normal collaterals in asymptomatic patients
Strong palmar arch and
collateralis from the
interosseal artery
to the palmar arch
Anatomic background (collaterals)
Ulnar artery occlusion + week collateralis from the interosseal artery +
diseased palmar arch
Failed collaterals in symptomatic CHI patient
After ulnar artery
angioplasty
PTA in CHI- Study design
Design
• DESIGN: Prospective, non-
randomized, multi-center clinical
evaluation of the angioplasty in CHI
(Pilot study)
• OBJECTIVE: To evaluate the
feasibility, safety and outcomes
of PTA in the treatment of CHI.
• PRINCIPAL INVESTIGATOR
Zoltán Ruzsa 1,2
• Balázs Nemes, Béla Merkely 1
• Imre Ungi 3
1. Semmelweis University, Heart Center, Budapest
2. Bács-Kiskun County Hospital
3. University of Szeged
75 patients with CHI enrolled
Between 2011 and 2013 in 3 clinical
sites in Hungary
75 patients underwent balloon angioplasty
(10 patients drug eluting balloon)
Angiographic
follow-up only in
symptomatic
patients
(N=7, 9,6 %)
Clinical follow-up at
2 months in 100%
(N=75)
Long term follow-
up to 12 months
in 100% (N=63)
Methods
• Inclusion criteria
– 1) acute and chronical critical hand ischemia associated with
pain at rest and/or ischaemic hand lesions (finger gangrene
or ulceration);
– 2) the presence of haemodynamic significant lesions, defined
as a ≥50% diameter stenosis or occlusion involving the
subclavian, axillo-barchial and radial, ulnar or interosseous
artery (the distal arches originating from the radial or ulnar
arteries were considered part of these arteries).
– 3) patients presented with CHI after transradial or
transbrachial angioplasty
• Exclusion criteria
– 1) forearm claudication and subclavian steel syndrome due
to subclavian artery stenosis
– 2) thoracic outlet syndrome
– 3) patients with Cimino Brescia fistulae at the ipsilateral site
Angioplasty: Access
• 6F Transfemoral access and 90 cm long sheath for subclavian artery
recanalisation or 6F JR5 catheter for axillary and brachial artery PTA
• Bilateral access for failed anterograde recanalisation (6F radial or
brachial and 6F femoral)
• Anterograde 5F brachial in isolated below-the-elbow disease
• Palmar arch (loop) technique in failed BTE disease after failed
anterograde recanalisation
Angioplasty of BTE disease
3 months FU
Anterograde brachial access with 5F sheath
Selective angio via
the sheath
Angioplasty technique for BTE disease (CHI
• 1. Anterograde access with 5F femoral sheath or 6F transfemoral access and
coronary guiding catheter (6F JR5)
• 2. Coronary guidewire
– Hydrophilic GW in soft occlusions (Pilot 50-200, PT Graphix)
– Penetration GW in calcified lesion (Miracle Bros 6-12, Progress 40)
• 3. Low profile OTW ballon
– Below-the-knee ballon- Amphirion Deep, FOX SV
– Drug Eluting balloon (only in 2015)
• 4. Stenting in bail out cases (self expandable of balloon expandable)
Xpert 5x60 and 4x30
Treatment of Acute Hand Ischemia
• A. Large thrombus- local thrombolysis for 24 hours
in the case of large thrombus
• Controll angiography after 24 hours
• B. Small thrombus- Thrombus aspiration
• Angioplasty and stenting when residual stenosis is
present
AHI treatment
AHI treatment
Demographic and clinical data
n, %
Age (years) 60.8 ± 17.4
Female 28 (38.3)
Hypertension 65 (89)
Hyperlipidaemia 50 (68.5)
Diabaetes mellitus 17 (23.3)
Smokers 9 (12.3)
Renal failure 24 (32.9)
Coronary artery disease 32 (43.8)
Peripheral artery disease 40 (54.8)
Angiographic data
Angiographic data Subclavian
(n=22)
Axillary- Brachial
(n=28)
Below the ankle
(n=46)
- UA= 20
- RA= 25
- IA= 1
- Palmar arch: 4
- Digital arteries: 1
Diameter stenosis (%) 92.6 ± 16.5 92.5 ± 16.6 93.6 ± 14.9
Reference diameter (mm) 4.72 ± 2.15 4.75 ± 2.11 4.74 ± 2.2
Chronic total occlusion (n) 10 (45.45) 17 (81) 38 (82.6)
Lesion length (mm) 69.3 ± 70.6 70.0 ± 70.9 70.4 ± 72.6
Severe calcification (n) 17.0 (77.3) 9 (42.8) 26 (56.5)
Intraluminary thrombus (n) 4.0 (18.2) 15 (71.4) 9 (19.6)
Indication
n, %
Rest pain 67 (89.3)
Digital ulcer 1 (1.3)
Digital gangrene 7 (9.3)
Etiology
Acute hand ischemia
n=17, (%)
Chronic hand ischemia
n=58, n (%)
Causes
- Idiopathic
- Atherosclerosis / Thrombosis
- Embolism
- Trauma / iatrogenic
- Vasculitis
- Other
0
7 (41.2)
8 (47)
2 (11.7)
0 (0)
0 (0)
0
43 (74.1)
1 (1.7)
12 (20.7)
2 (3.5)
0 (0)
Procedural data and success
Successful
n= 15 (88.2%)
Successful
n= 56 (96.6%)
Unsuccessful
n= 2 (0%)
Unsuccessful
n= 2 (3.4%)
Acute critical hand ischemia
n= 17 (%)
Thrombolyisis 9 (52.9)
Aspiration: 8 (47.1)
PTA: 14 (82.3)
Stent: 5 (29.4))
Chronic critical hand ischemia
n= 58 (%)
Aspiration: 3 (5.2 )
PTA: 57 (98.3 )
Rotarex: 0 (0 )
Stent: 27 (46.5)
Dilated arteries n, (%)
Subclavian and Anonym artery 22 (29.3)
Axillary artery 6 (8)
Brachail artery 22 (29.3)
Radial artery 25 (33.3)
Ulnar artery 20 (26.7)
Interosseal artery 1 (1.3)
Palmar arch 7 (9.3)
Device consumption
Equipments n, (%)
Guiding sheath and catheter 82 (109)
Guidewire 0.035”-0.18”-0.14” 196 (261.3)
Balloon 120 (160)
Drug Eluting balloon 10 (13.3)
Stent 43 (57.3)
Thrombus aspiration 5 (6.6)
Atherectomy 1 (1.3)
Clinical success
Clinical success Patients
n, (%)
Releaved rest pain
- Primary pain (n=67) 64 (85.3)
Healing of ulcer and gangrene (n=8) 8 (100)
Avoidance of unplanned amputation
and surgical procedure (n=75)
74 (1.2)
Target lesion revascularisation
• TLR n (%)
– Acute stent thrombosis 1 (1.3)
– Radial artery occlusion 2 (2.7)
– Restenosis 9 (12)
SUMMARY 12 (16)
Major adverse events
MAE 2 months FU n, % 1 year FU n, %
Myocardial infarction 1 1
Major unplaned amputation 0 0
Urgent PTA or bypass 2 2
Death 8 14
Summary 12 (16%) 17 (22,6)
Long term clinical TLR
Procedure releated complications
Complication n (%)
Perforation 1 (1.3)
Distal embolisation 1 (1.3)
Abrupt vessel closure /
dissection
3 (4)
Compartment syndrome 0 (0)
Other - TIA 1 (1.3)
Access site complications
TCT 2011
Femoral access: n (%)
-Pseudoaneurysm:
-Major haematoma
-Major bleeding:
-AV fistula:
0 (0)
1 (1.3)
0 (0)
0 (0)
Brachial access: n (%)
-Occlusion:
-Spasm:
-Pseudoaneurysm:
-AV fistula:
-Compartment syndrome
0 (0)
2 (10)
1 (0)
0 (0)
0 (0)
Conclusion
- The anatomical background of the CHI is the main vessel
CTO in the inflow vessels and the main vessel CTO
without good collaterals (small or diseased) in the BTE
disease
- Acute hand ischemia and subacute CHI is associated
with thrombus and local throbolysis and thrombus
aspiration is feasible in these cases with additional PTA
and stenting
- - Angioplasty of the hand vessels for CHI is a feasible and
safe procedure with acceptable rates of technical
success and hand healing.
- Long term rate of major adverse events is high
- Long term target lesion revascularisation is high

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Ruzsa Z - AIMRADIAL 2015 - Angioplasty of the hand

  • 1. AimRadial 2015 Angioplasty of the hand arteries in critical hand ischaemia Zoltán Ruzsa, Imre Ungi, Balázs Nemes, Júlia Tóth, András Katona, Kálmán Hüttl, Béla Merkely
  • 2. Disclosure Statement of Financial Interest I, Zoltán Ruzsa MD. PhD. DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.
  • 3. Background Critical hand ischaemia (CHI) of the upper extremity is rarely encountered. Axillary, brachial and below-the-elbow (BTE) disease is often asymptomatic due to highly developed collaterals, but in diffuse- multiple and thrombotic disease CHI can develop. There are only case reports1,2 and limited number of studies 3,4 of the angioplasty in critical hand ischemia. The aim of this prospective study was to assess the feasibility, safety and outcomes of percutaneous transluminal angioplasty (PTA) in the treatment of CHI. 1. Ruzsa. Cardiovasc Revasc Med. 2010 Oct-Dec;11(4):266.e1-4. 2. Rademakers LM. Neth Heart J. 2012 Sep;20(9):372-5. 3. Kawarada O. Catheter Cardiovasc Interv. 2010 Sep 1;76(3):345-50. 4. Gandini R. J Vasc Surg. 2010 Mar;51(3):760-2.
  • 4. Anatomical background • Anatomy of the upper extremity – Inflow arteries • Brachiocephalic and subclavian artery – Intrinsic arteries • Axillary, brachial, radial, ulnar, palmar and digital arteries • Deep and superfitial palmar arch • Anomalous circulation – The paralell arterial systems of upper extremity allow to maintain the normal perfusion at rest even in the setting of a significant stenosis • Collateral pathways – Shoulder and elbow collaterals • Ad. 1 Subclavian occlusion – vertebral collaterals • Ad 2. Brachial occlusion- collateralis from the distal to proximal arm • Ad. 3 Radial or ulnar occlusion- collateralis from the interosseal or palmar arch
  • 5. Pathophysiology of CHI Macrovascular disease Microvascular disease Patient with ulnar artery occlusion Patient with renal failure, on haemodialysis
  • 6. Anatomical background Ulnar artery occlusion Ulnar artery occlusion Normal collaterals in asymptomatic patients Strong palmar arch and collateralis from the interosseal artery to the palmar arch
  • 7. Anatomic background (collaterals) Ulnar artery occlusion + week collateralis from the interosseal artery + diseased palmar arch Failed collaterals in symptomatic CHI patient After ulnar artery angioplasty
  • 8. PTA in CHI- Study design Design • DESIGN: Prospective, non- randomized, multi-center clinical evaluation of the angioplasty in CHI (Pilot study) • OBJECTIVE: To evaluate the feasibility, safety and outcomes of PTA in the treatment of CHI. • PRINCIPAL INVESTIGATOR Zoltán Ruzsa 1,2 • Balázs Nemes, Béla Merkely 1 • Imre Ungi 3 1. Semmelweis University, Heart Center, Budapest 2. Bács-Kiskun County Hospital 3. University of Szeged 75 patients with CHI enrolled Between 2011 and 2013 in 3 clinical sites in Hungary 75 patients underwent balloon angioplasty (10 patients drug eluting balloon) Angiographic follow-up only in symptomatic patients (N=7, 9,6 %) Clinical follow-up at 2 months in 100% (N=75) Long term follow- up to 12 months in 100% (N=63)
  • 9. Methods • Inclusion criteria – 1) acute and chronical critical hand ischemia associated with pain at rest and/or ischaemic hand lesions (finger gangrene or ulceration); – 2) the presence of haemodynamic significant lesions, defined as a ≥50% diameter stenosis or occlusion involving the subclavian, axillo-barchial and radial, ulnar or interosseous artery (the distal arches originating from the radial or ulnar arteries were considered part of these arteries). – 3) patients presented with CHI after transradial or transbrachial angioplasty • Exclusion criteria – 1) forearm claudication and subclavian steel syndrome due to subclavian artery stenosis – 2) thoracic outlet syndrome – 3) patients with Cimino Brescia fistulae at the ipsilateral site
  • 10. Angioplasty: Access • 6F Transfemoral access and 90 cm long sheath for subclavian artery recanalisation or 6F JR5 catheter for axillary and brachial artery PTA • Bilateral access for failed anterograde recanalisation (6F radial or brachial and 6F femoral) • Anterograde 5F brachial in isolated below-the-elbow disease • Palmar arch (loop) technique in failed BTE disease after failed anterograde recanalisation
  • 11. Angioplasty of BTE disease 3 months FU Anterograde brachial access with 5F sheath Selective angio via the sheath
  • 12. Angioplasty technique for BTE disease (CHI • 1. Anterograde access with 5F femoral sheath or 6F transfemoral access and coronary guiding catheter (6F JR5) • 2. Coronary guidewire – Hydrophilic GW in soft occlusions (Pilot 50-200, PT Graphix) – Penetration GW in calcified lesion (Miracle Bros 6-12, Progress 40) • 3. Low profile OTW ballon – Below-the-knee ballon- Amphirion Deep, FOX SV – Drug Eluting balloon (only in 2015) • 4. Stenting in bail out cases (self expandable of balloon expandable) Xpert 5x60 and 4x30
  • 13. Treatment of Acute Hand Ischemia • A. Large thrombus- local thrombolysis for 24 hours in the case of large thrombus • Controll angiography after 24 hours • B. Small thrombus- Thrombus aspiration • Angioplasty and stenting when residual stenosis is present
  • 16. Demographic and clinical data n, % Age (years) 60.8 ± 17.4 Female 28 (38.3) Hypertension 65 (89) Hyperlipidaemia 50 (68.5) Diabaetes mellitus 17 (23.3) Smokers 9 (12.3) Renal failure 24 (32.9) Coronary artery disease 32 (43.8) Peripheral artery disease 40 (54.8)
  • 17. Angiographic data Angiographic data Subclavian (n=22) Axillary- Brachial (n=28) Below the ankle (n=46) - UA= 20 - RA= 25 - IA= 1 - Palmar arch: 4 - Digital arteries: 1 Diameter stenosis (%) 92.6 ± 16.5 92.5 ± 16.6 93.6 ± 14.9 Reference diameter (mm) 4.72 ± 2.15 4.75 ± 2.11 4.74 ± 2.2 Chronic total occlusion (n) 10 (45.45) 17 (81) 38 (82.6) Lesion length (mm) 69.3 ± 70.6 70.0 ± 70.9 70.4 ± 72.6 Severe calcification (n) 17.0 (77.3) 9 (42.8) 26 (56.5) Intraluminary thrombus (n) 4.0 (18.2) 15 (71.4) 9 (19.6)
  • 18. Indication n, % Rest pain 67 (89.3) Digital ulcer 1 (1.3) Digital gangrene 7 (9.3) Etiology Acute hand ischemia n=17, (%) Chronic hand ischemia n=58, n (%) Causes - Idiopathic - Atherosclerosis / Thrombosis - Embolism - Trauma / iatrogenic - Vasculitis - Other 0 7 (41.2) 8 (47) 2 (11.7) 0 (0) 0 (0) 0 43 (74.1) 1 (1.7) 12 (20.7) 2 (3.5) 0 (0)
  • 19. Procedural data and success Successful n= 15 (88.2%) Successful n= 56 (96.6%) Unsuccessful n= 2 (0%) Unsuccessful n= 2 (3.4%) Acute critical hand ischemia n= 17 (%) Thrombolyisis 9 (52.9) Aspiration: 8 (47.1) PTA: 14 (82.3) Stent: 5 (29.4)) Chronic critical hand ischemia n= 58 (%) Aspiration: 3 (5.2 ) PTA: 57 (98.3 ) Rotarex: 0 (0 ) Stent: 27 (46.5) Dilated arteries n, (%) Subclavian and Anonym artery 22 (29.3) Axillary artery 6 (8) Brachail artery 22 (29.3) Radial artery 25 (33.3) Ulnar artery 20 (26.7) Interosseal artery 1 (1.3) Palmar arch 7 (9.3)
  • 20. Device consumption Equipments n, (%) Guiding sheath and catheter 82 (109) Guidewire 0.035”-0.18”-0.14” 196 (261.3) Balloon 120 (160) Drug Eluting balloon 10 (13.3) Stent 43 (57.3) Thrombus aspiration 5 (6.6) Atherectomy 1 (1.3)
  • 21. Clinical success Clinical success Patients n, (%) Releaved rest pain - Primary pain (n=67) 64 (85.3) Healing of ulcer and gangrene (n=8) 8 (100) Avoidance of unplanned amputation and surgical procedure (n=75) 74 (1.2)
  • 22. Target lesion revascularisation • TLR n (%) – Acute stent thrombosis 1 (1.3) – Radial artery occlusion 2 (2.7) – Restenosis 9 (12) SUMMARY 12 (16)
  • 23. Major adverse events MAE 2 months FU n, % 1 year FU n, % Myocardial infarction 1 1 Major unplaned amputation 0 0 Urgent PTA or bypass 2 2 Death 8 14 Summary 12 (16%) 17 (22,6)
  • 25. Procedure releated complications Complication n (%) Perforation 1 (1.3) Distal embolisation 1 (1.3) Abrupt vessel closure / dissection 3 (4) Compartment syndrome 0 (0) Other - TIA 1 (1.3)
  • 26. Access site complications TCT 2011 Femoral access: n (%) -Pseudoaneurysm: -Major haematoma -Major bleeding: -AV fistula: 0 (0) 1 (1.3) 0 (0) 0 (0) Brachial access: n (%) -Occlusion: -Spasm: -Pseudoaneurysm: -AV fistula: -Compartment syndrome 0 (0) 2 (10) 1 (0) 0 (0) 0 (0)
  • 27. Conclusion - The anatomical background of the CHI is the main vessel CTO in the inflow vessels and the main vessel CTO without good collaterals (small or diseased) in the BTE disease - Acute hand ischemia and subacute CHI is associated with thrombus and local throbolysis and thrombus aspiration is feasible in these cases with additional PTA and stenting - - Angioplasty of the hand vessels for CHI is a feasible and safe procedure with acceptable rates of technical success and hand healing. - Long term rate of major adverse events is high - Long term target lesion revascularisation is high