Photoablation and DCB in in-stent restenosis

Transcription

1 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

2 Disclosure Speaker name:... I have the following potential conflicts of interest to report: X 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

3 Single Center US Experience Registry in treating very long segment highly symptomatic chronic SFA total in-stent occlusions.

4 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

5 Background: fem-pop ISR ISR vs. de-novo: different pattern, higher restenosis burden Initial (de-novo) lesion Hydrated collagen matrix (watery sponge; 60-80% of NIH volume) Dense rubbery cap of smooth muscle cells ISR Calcium: rare Thrombus: can be present, but typically a small part of the total volume 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 Jul 1;91(1): Inoue S, Koyama H, Miyata T, Shigematsu H. Pathogenetic heterogeneity of in-stent lesion formation in human peripheral arterial disease. J Vasc Surg Apr;35(4): 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 Feb;36(1):

6 LASER Recanalization, Debulking and Plaque Modification Photochemical: Molecular bond break Photothermal Thermal energy Photomechanical Kinetic energy Recanalization (Pilot Channel) Plaque vaporization Limited embolization No moving blades Only FDA approved Atherectomy for ISR 6

7 Laser in long fem-pop ISR 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 Laser + PTA vs. 6-month: 71.1% vs. 56.4% (p=0.004) 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 Jan;8(1 Pt A):

8 Laser + DCB DCB alone Laser + DCB pre-clinical Insights 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 R.Virmani VIVA

9 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) Apr;53(2):

10 Laser+DCB vs. DCB in long, occlusive ISR: RCT 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) 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 drugeluting balloon angioplasty in patients with critical limb ischemia: a single-center, prospective, randomized study. J Endovasc Ther Dec;20(6):

11 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

12 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.

13 24 patients treated between Feb 2015 June Rutherford 3 2 Rutherford 4 (Both had severe Profunda disease). Lesion length 18cm 43cm (mean 28cm) Pt age males 5 females Reference vessel diameter 4mm 2 pts 5mm 19 pts 6mm 3 pts

14 Baseline hemodynamis ABI (Mean.52) Duplex Totally occluded segment

15 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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23 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

24 Clinical findings in 21 patients at 6 mos 18 pts Rutherford 0 2 pts Rutherford 2 1 pt Rutherford 3

25 Objective findings at 6 mos ABI (Average.92) Art Duplex 19 patients, no significant stenosis PSVR <2 1 patient, total SFA occlusion (had stopped antiplatelet drugs) 1 patient, had several high grade lesions

26 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

27 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.

28 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