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Drug eluting balloons for critical limb ischaemia (cli)
- 1. Dr Steven Kum Vascular & Endovascular Surgeon Vascular Centre Department of Surgery Changi General Hospital
- 2. • 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
- 3. Our CLI Strategy How DEB fits into our strategy Controversies in DEB
- 4. Clear Infection Revascularization Clean Granulating Wound Skin Coverage/Reconstruction
- 6. Wound spans multiple angiosomes Late presentation with severe tissue loss Small vessels and long CTOs
- 8. Wound healing before restenosis Early return to meaningful walking function with freedom from re-ulceration 1° 2°
- 9. NOT a good Angiogram
- 14. Angiosome Concept is even more important…
- 15. Endovascular CLI Strategy R4 Rest pain R5 Minor loss R6 Major loss Revasc ATK +/- BTK Revasc ATK + BTK Open single Appropriate Angiosome Able to open Boundary Angiosome only Early definitive foot surgery and skin closure before restenosis Close follow- up KIV Bypass Open multiple tibials 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 early bypass if wound deteriorates or unable to open angiosome Adapted from Peter Schneider Revasc ATK + BTK
- 18. Alexandrescu et al. J Endovasc Ther 2011;18:376
- 23. 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
- 24. Only ½ of the patients have complete healing at 6 months after bypass or PTA/stent for Rutherford 5/6 lesions.
- 25. 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 infrapopliteal angioplasty. Europ J of Vasc and Endovasc Surgery 2012
- 31. Lesion length = 12 cm Occlusions = 80% Angio: 81% (DEB) / 89% (PTA) Duplex: 18% (DEB) / 11% (PTA)
- 34. 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
- 35. 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 Cardiol 2011;58:1105–9
- 37. Endovascular CLI Strategy R4 Rest pain R5 Minor loss R6 Major loss Revasc ATK +/- BTK Revasc ATK + BTK Open single Appropriate Angiosome Able to open Boundary Angiosome only (plantar arch intact) Open multiple tibials especially if high risk Adapted and modified from Peter Schneider Revasc ATK + BTK •Renal failure •Incomplete plantar arch •Large wound burden •High surgical risk DEB Early definitive foot surgery before restenosis Close follow- up KIV Bypass Consider early bypass if wound deteriorates or unable to open angiosome
- 39. DEB to P3 DEB to Lateral Plantar Artery
- 41. 2 years post DEB to ATA and DP Triphasic Occluded dATA DEB
- 43. DEB to Pop and ATA VAC 5 Months Later
- 44. 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
- 45. DEB to distal anastamosis, Popliteal and Peroneal Peroneal Occlusion Stenosis No restenosis 2 years post DEB Femoral –AK Pop bypass with Acute Limb Ischaemia - Post Thrombolysis
- 47. 2 and half years post DEB
- 48. Retrograde Double balloon Stump of bypass Occluded Pop-DP bypass
- 49. 18 months 24 monthsInitial DEB ATA and DP
- 50. 3 months post ATA and DP DEB Hyallomatrix and SSG
- 55. ATA no significant stenosis 2 years post DEB Initial angio showing long ATA Occlusion 2 years
- 56. Use of DEB in calcified lesions DEB with or without vessel prepararion (eg scoring/cutting, artherectomy Cost benefit analysis of using DEBs DEBs in the context of on going severe sepsis
- 58. 75 % TASC B and C lesions 30% occlusions Mostly claudicants
- 60. 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
- 61. Porcine Studies
- 62. • Morbidity and outcomes of German patients with PAD 2005-2009 •Per case cost 2009 IC: 4506 € •Per case cost 2009 CLI: 6791 €
- 63. Courtesy Zeller
- 64. Courtesy Zeller
- 65. Courtesy Zeller
- 67. Team based approach Endocrinology DM Centre Orthopaedics Foot & Ankle PodiatryAnaesthesiaWound Care Team Vascular Interventionalist and Surgeon Family Physicians
- 68. 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
Editor's Notes
- We would consider DEB in patients with R5 minor tissue loss with boundary revascularization or R6 significant tissue loss i.e. high wound burden In our experience, both categories highlighted in red circle require a longer time for wound closure and hence will benefit from prolonged vessel patency
- In this frail and old patient who is an unlikely candidate for bypass who has some rest pain from the SFA ISR, it offers a valuable tool to us
- This patient is one of our early cases with DEB. He underwent a staged SFA angioplasty followed by Popliteal to lateral plantar bypass for CLI. Several months later developed SFA restenosis jeopodising the bypass graft as you can see by the tight stenosis just before the Vein Hood. This was treated with INPACT Pacific DEB in Oct 2010
- 2 years and 6 months post Poplital to Lateral Plantar bypass, we still have preserved Proximal inflow to drive the graft after DEB. He remains wound free and is walking!
- At 18 months, there was no flow limiting stenosis. Some stenosis however developed at 24 months. DEBs do not prevent restenosis but delay the process
- POBA has poor results in renal failure. This patient had primary DEB to ATA and DP for forefoot wet gangrene. With our increasing confidence in the technology, we have started applying DEB primarily at our first intervention for patients like this with extensive lesions and Renal Failure who have a high risk of restenosis. With aggressive skin coverage with dermal substitutes and SSG, we can achieve closure before restenosis
- This patient had CLI and SFA stent inserted as well as ATA and DP DEB 2 years ago. She developed rest pain and SFA ISR which we drugged. Images show of the 2 year angiographic patency of ATA demonstrating the effect of the DEB