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Photoablation and DCB in in-stent restenosis
Craig M. Walker, MD, FACC, FACP
Clinical Professor of Medicine
Tulane University School of Medicine
New Orleans, LA
Clinical Professor of Medicine
LSU School of Medicine
New Orleans, LA
Founder, President, and Medical Director
Cardiovascular Institute of the South
Houma, LA
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Disclosure
Speaker name:
.................................................................................
I have the following potential conflicts of interest to report:
Consulting
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
X
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• Single Center US Experience Registry in treating very long segment highly symptomatic chronic SFA total in-stent occlusions.
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Inclusion Criteria
• Documented chronic total occlusion (≥2 mos) of SFA stents ≥ 18 cm
• Rutherford 3 or 4 classification (no mild claudicants or established tissue loss)
• At least one patent run-off vessel
• No type 3 or 4 stent fractures
• Lesions crossable
• TIMI 3 flow before DEB
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Background: fem-pop ISR
1. Osherov AB, Gotha L, Cheema AN, Qiang B, Strauss BH. Proteins mediating collagen biosynthesis and accumulation in arterial repair: novel targets for
anti-restenosis therapy. Cardiovasc Res. 2011 Jul 1;91(1):16-26
2. Inoue S, Koyama H, Miyata T, Shigematsu H. Pathogenetic heterogeneity of in-stent lesion formation in human peripheral arterial disease. J Vasc Surg.
2002 Apr;35(4):672-8
3. Brodmann M, Rief P, Froehlich H, Dorr A, Gary T, Eller P, Hafner F, Deutschmann H, Seinost G, Pilger E. Neointimal hyperplasia after silverhawk
atherectomy versus percutaneous transluminal angioplasty (PTA) in femoropopliteal stent reobstructions: a controlled, randomized pilot trial. Cardiovasc
Intervent Radiol. 2013 Feb;36(1):69-74
ISR vs. de-novo: different pattern, higher restenosis burden
Initial (de-novo)
lesion
ISR Dense rubbery cap of
smooth muscle cells
Hydrated collagen matrix (watery sponge; 60-80% of NIH volume)
Calcium: rare
Thrombus: can be present, but typically
a small part of the total volume
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LASER
Recanalization (Pilot Channel)
Plaque vaporization
Limited embolization
No moving blades
Only FDA approved Atherectomy for ISR
Recanalization, Debulking and Plaque Modification
Photochemical: Molecular bond break
Photothermal Thermal energy
Photomechanical Kinetic energy
√ √ √ √ √
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Laser in long fem-pop ISR
Laser + PTA vs. PTA @ 6-month:
71.1% vs. 56.4% (p=0.004)
Primary Patency
EXCITE ISR RCT Laser + PTA vs. PTA in fem-pop ISR • 250 Patients (169 ELA+PTA vs. 81 PTA)
• Occlusive ISR: 30.5% vs.36.8%
• Mean ISR length: 19 cm
Laser + PTA better than PTA, proportionally better in longer lesions
• Dippel EJ, Makam P, Kovach R, George JC, Patlola R, Metzger DC, Mena-Hurtado C, Beasley R, Soukas P, Colon-Hernandez PJ, Stark MA, Walker C; EXCITE ISR
Investigators. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial
(EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):92-101
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Laser + DCB pre-Clinical Insights
R.Virmani VIVA 2015
DC
B a
lon
e
Reduced % stenosis and intimal thickness with Laser+DCB vs. DCB alone at 28 days in pre-clinical ISR model
Rabbit model of (carotid) CTO ISR treated by Laser + DCB vs. DCB alone
Lase
r +
DC
B
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Laser + DCB in ISR: Clinical Insights
• SFA-ISR case series (N=14) 13 cm, treated with Laser+DCB
• Time to first TLR (after PTA) = 8 months
Reduced TLR rate and time-to-TLR vs. initial PTA treatment
1 TLR (7%) at 3 years
• Van Den Berg JC, Pedrotti M, Canevascini R, Chimchila Chevili S, Giovannacci L, Rosso R. Endovascular treatment of in-stent restenosis using excimer laser
angioplasty and drug eluting balloons. J Cardiovasc Surg (Torino). 2012 Apr;53(2):215-22
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Laser+DCB vs. DCB in long, occlusive ISR: RCT
12-month Primary Patency
ELA + DCB vs. DCB:
66.7% vs. 37.5% (p=0.01)
Significant reduction of TLR and
MAE and improved wound healing
with Laser + DCB vs. DCB alone at
12 months
• Gandini R, Del Giudice C, Merolla S, Morosetti D, Pampana E, Simonetti G. Treatment of chronic SFA in-stent occlusion with combined laser atherectomy and drug-
eluting balloon angioplasty in patients with critical limb ischemia: a single-center, prospective, randomized study. J Endovasc Ther. 2013 Dec;20(6):805-14
• Single center randomized trial (Laser+DCB vs. DCB)
• N=48; CLI: 100%; Diabetes: 100% • Occlusive ISR (Tosaka III): 100% • mean ISR treated length: 22.4±9.4
(Laser + DCB) vs. 25.9±8.7 cm (DCB)
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Planned Follow-up Evaluation
• Pre procedural ABI, Duplex, Rutherford
• 1 month clinical evaluation
• 6 month clinical evaluation, ABI, Art Duplex
• 1 yr clinical evaluation, ABI, Art Duplex
• Yearly clinical evaluation, ABI, Art Duplex
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Treatment Protocol
• All SFA treatment via contralateral approach to avoid prolonged compression of treated artery.
• Following angiography lesion crossed and treated with Turbo-Elite laser catheter (2 passes at 1mm/sec advancement rate).
• Repeat angiography.
• PTA with non-compliant balloon to reference vessel size for 2 minutes).
• Repeat Angio.
• Drug-Eluting PTA of entire treated segment avoiding treatment miss (Two minute inflations).
• Angiography.
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24 patients treated between Feb 2015 – June 2015
• 22 Rutherford 3
• 2 Rutherford 4 (Both had severe Profunda disease).
• Lesion length 18cm – 43cm (mean 28cm)
• Pt age 48 - 78
• 19 males 5 females
• Reference vessel diameter
– 4mm 2 pts
– 5mm 19 pts
– 6mm 3 pts
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Baseline hemodynamis
• ABI 0.3 – 0.76 (Mean .52)
• Duplex – Totally occluded segment
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Acute Treatment Outcomes
• All lesions were crossed (in 3 cases laser step by step approach was required)
• Following laser atherectomy angiography disclosed a patent channel with TIMI 3 flow in 23/24. One pt had TIMI 2 flow treated successfully with local 2B/3A administration
• Following intial PTA 22/24 widely patent with TIMI 3 flow. 2 had TIMI 1 flow treated successfully with local 2B/3A
• Following DEB all 24 had excellent angiographic result with TIMI 3 flow.
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Follow-up
• 24 patients treated within time period to assess 6 month outcomes
• 2 patients did not return for visits or follow-up but were reached by phone (Patients stated they were a symptomatic)
• 1 patient could not be reached
• 21 patients returned to office for full evaluation
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Clinical findings in 21 patients at 6 mos
• 18 pts Rutherford 0
• 2 pts Rutherford 2
• 1 pt Rutherford 3
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Objective findings at 6 mos
• ABI .52 – 1.3 (Average .92)
• Art Duplex
– 19 patients, no significant stenosis PSVR <2
– 1 patient, total SFA occlusion (had stopped anti-platelet drugs)
– 1 patient, had several high grade lesions
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Major Adverse Events at 6 mos
• 1 pt had clinically driven TLR → Laser + DEB with good initial result
• No deaths or CVA
• No major bleeding requiring transfusion
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Conclusion
• The treatment of long-segment SFA in-stent occlusions is challenging and has been historically associated with poor patency. Laser de-bulking followed by DEB is feasible. These initial outcomes are encouraging but longer-term evaluation is needed.
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Photoablation and DCB in in-stent restenosis
Craig M. Walker, MD, FACC, FACP
Clinical Professor of Medicine
Tulane University School of Medicine
New Orleans, LA
Clinical Professor of Medicine
LSU School of Medicine
New Orleans, LA
Founder, President, and Medical Director
Cardiovascular Institute of the South
Houma, LA