Drug eluting balloons for critical limb ischaemia (cli)
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Transcript of Drug eluting balloons for critical limb ischaemia (cli)
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Dr Steven Kum
Vascular & Endovascular Surgeon
Vascular Centre
Department of Surgery
Changi General Hospital
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• 900 bed Tertiary Hospital• 12.7 % of adults are
diabetic• On average of 1 CLI per
day mostly due to Diabetes
• Vascular Team handles Revascularization and Wound Care/Reconstruction
• Simultaneous Revascularization and Soft Tissue work performed in Hybrid OR
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Our CLI Strategy
How DEB fits into our strategy
Controversies in DEB
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Clear Infection Revascularization
Clean Granulating Wound
Skin Coverage/Reconstruction
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SMOKERS DIABETICS
Above the knee
Below the knee
MIXED
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Wound spans multiple angiosomes
Late presentation with severe tissue loss
Small vessels and long CTOs
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Wound healing before restenosis
Early return to meaningful walking
function with freedom fromre-ulceration
1°
2°
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NOT a good Angiogram
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Angiosome Concept is even more important…
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Endovascular CLI Strategy
R4Rest pain
R5Minor loss
R6Major loss
Revasc ATK +/- BTK Revasc ATK + BTK
Open singleAppropriate Angiosome
Able to open
Boundary Angiosome
only
Early definitive foot surgery and skin closure before restenosis
Close follow-up KIV Bypass
Open multipletibials especially if
high risk
•Wound across 2 angiosomes•Renal failure•Incomplete plantar arch•Large wound burden eg TMA•Non ambulatory status•High surgical risk
Consider earlybypass if wound deteriorates or unable to open angiosome Adapted from
Peter Schneider
Revasc ATK + BTK
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Direct Angiosome
Boundary Angiosome
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Direct Angiosome
Direct Angiosome
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Alexandrescu et al. J Endovasc Ther2011;18:376
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101 Patients
12m Angio
PTA arm PTA arm
60 Patients
10m Angio
33 Patients
6m Angio
11 Patients
12m Angio
67 Patients
12m Angio
58 Patients
3m Angio
PTA arm
1. D.Scheinert, J Am Coll Cardiol 2012;60:2290–5)
2. H.K.Soder, J Vasc Interv Radiol 2000; 11:1021–1031
3. F. Baumann, J Vasc Interv Radiol 2011; 22:1665–1673
4. F.Fanelli, J Endovasc Ther. 2012;19:571–580
5. F.Liistro, TCT 2012 oral presentation
6. A.Schmidt, Catheter Cardiovasc Interv. 2010 Dec 1;76(7):1047-54
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Only ½ of the patients have complete healing at 6 months after bypass or PTA/stent for Rutherford 5/6 lesions.
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Patency
• makes healing faster and healing rates
higher
• Protects foot against recrudescence and
recurrences
Primary Patency
• better than secondary patency
• reduces TLR and adds life and QoL
T.Kudo et al. The effectiveness of percutaneous transluminal angioplasty for the treatment
of critical limb ischemia: A 10-year experience. J Vasc Surg 2005;41:423-35.)
Conte M.S Suggested objective performance goals and clinical trial design for evaluating
catheter-based treatment of critical limb ischemia. JVS 2009;50:1462-1473
O.Iida et al. angiographic restenosis and its clinical impact after infrapoplitealangioplasty. Europ J of Vasc and Endovasc Surgery 2012
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Necrotising Fascitis
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Prolonged patency from Drug Elution
=
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Lesion length = 12 cm Occlusions = 80%
Angio: 81% (DEB) / 89% (PTA) Duplex: 18% (DEB) / 11% (PTA)
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RESULTS –BTK TREATED
US PATENCY AT 6 MONTHS
34
30 legs available for analysis
<50% stenosis
(n = 3) 10.0%
No restenosis
(n = 20)66.7%
Occluded
(n =2) 6.6%
All were focal
>50% stenosis
(n = 5)16.7%
All were focal
Re-stenosis rate: 23.3%
Clinically driven TLR was 10 % at 6 months
No or low grade stenosis: 76.7%
•63.3% occlusions
•60% Restenosis or ISR
•Lesion length > 12 cm
•86.7% moderate or severe
calcification
•100% R5/R6 CLI
> 50% stenosis defined by PSV ratio> 2
Clinical Distal Pulse felt in 83.3 % of patients
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1.F.Fanelli et al. JEVT 2012;19:571–580
2.A.Cioppa – EuroPCR 2012 3.F.Liistro – TCT 2012 2011
4. K.Suzuki – LINC Asia Pacific 2012
5. A.Schmidt et al. J Am Coll Cardiol2011;58:1105–9
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Endovascular CLI Strategy
R4Rest pain
R5Minor loss
R6Major loss
Revasc ATK +/- BTKRevasc ATK + BTK
Open singleAppropriate Angiosome
Able to open Boundary
Angiosomeonly (plantar arch intact)
Open multipletibials especially if
high risk
Adapted and modified from Peter Schneider
Revasc ATK + BTK
•Renal failure•Incomplete plantar arch•Large wound burden •High surgical risk
DEBEarly definitive foot surgery before restenosis
Close follow-up KIV Bypass
Consider earlybypass if wound deteriorates or unable to open angiosome
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DEB to P3 DEB to Lateral Plantar Artery
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2 years post DEB to ATA and DP Triphasic
Occluded dATA
DEB
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8 months of patency
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DEB to Pop and
ATA
VAC
5 Months Later
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Feb 2011
No restenosis seen
2 1/2 years
DEB from P3 to SFA
Aug 2013
Prev Full Metal Jacket for CLI now rest pain
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DEB to distal anastamosis, Popliteal and
Peroneal
Peroneal Occlusion
Stenosis
No restenosis
2 years post DEBFemoral –AK Pop bypass
withAcute Limb Ischaemia - Post Thrombolysis
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2 and half years post DEB
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Retrograde Double balloon
Stump of
bypass
Occluded Pop-DP bypass
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18 months 24 monthsInitial
DEB ATA
and DP
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3 months post ATA and DP DEB
Hyallomatrix and SSG
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ATA no significant stenosis 2 years post DEB
Initial angioshowing long ATA
Occlusion
2 years
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Use of DEB in calcified lesions
DEB with or without vessel prepararion (egscoring/cutting, artherectomy
Cost benefit analysis of using DEBs
DEBs in the context of on going severe sepsis
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Courtesy F.Fanelli
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75 % TASC B and C lesions30% occlusions
Mostly claudicants
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7 to 15 cm long in femoropopliteal
48 patients were randomized to the Artherectomy + DEB arm and 54 patients to the DEB arm
30 day results presented at VIVA 2013 demonstrate safety and clinical improvement in Rutherford status
We await long term results if additional artherectomy is warranted
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Porcine Studies
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• Morbidity and outcomes of German patients with PAD 2005-2009
•Per case cost 2009 IC: 4506 €•Per case cost 2009 CLI: 6791 €
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Courtesy Zeller
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Courtesy Zeller
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Courtesy Zeller
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Team based approach
EndocrinologyDM Centre
OrthopaedicsFoot & Ankle
PodiatryAnaesthesiaWound Care Team
Vascular Interventionalist
and Surgeon Family Physicians
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Rutherford Status and extent of tissue loss determines which BTK vessels need to be treated
DEB has early promising in CLI for SFA and BTK disease, we await more RCTs
Use of DEBs especially for R5 with boundary angiosome and R6 wounds
Extravascular Care and early SSG will ensure a good clinical outcome rather than just a good angiographic result