TCAR: TransCarotid Artery Revascularization Angela A. Kokkosis, MD, RPVI, FACS

Transcription

1 TCAR: TransCarotid Artery Revascularization Angela A. Kokkosis, MD, RPVI, FACS Assistant Professor of Surgery Director of Carotid Interventions Division of Vascular & Endovascular Surgery Stony Brook University Medical Center

2 Disclosures Silk Road Medical Consultant, Faculty proctor AV Medical Consultant

3 Carotid Artery Stenting Symptomatic SPACE, EVA-3S, ICSS CAS higher risk stroke/death SAPPHIRE, CaRESS, CREST Overall no difference in outcomes CEA vs CAS CREST Periprocedural risks differed: Higher risk stroke(4.4 v 2.3%) CAS Higher risk MI(2.3 v 1.1%) CEA Asymptomatic SAPPHIRE, CaRESS, CREST Overall no difference in outcomes The Age factor: >70 years of age had almost 2x the risk of stroke with CAS (SPACE, EVA-3S, ICSS) 1. Ricotta JJ et al. Updated Society for Vascular Surgery guidelines for management of extracranial carotid disease. J Vasc Surg 2011; 54:e1-e31 2. Cronenwett and Johnston. Rutherford s Vascular Surgery, 8e. 2014

4 Carotid Artery Stenting Long term outcomes Stroke: 10yrs ~6.9% **NS difference from CEA** Restenosis rate(>50%) 6% at 1 year 10.8% at 5 years (ICSS) 12% at 10 years (CREST) **NS difference from CEA** 1. Ricotta JJ et al. Updated Society for Vascular Surgery guidelines for management of extracranial carotid disease. J Vasc Surg 2011; 54:e1-e31 2. Cronenwett and Johnston. Rutherford s Vascular Surgery, 8e ICSS trial follow-up, March N Engl J Med 2016;374:

5 National real-world data Nationwide Inpatient Sample ,080 CEA vs. CAS in the US Symptomatic Stroke rate 1.1% vs. 4.2% (p<.0001) Mortality rate 1.0% vs. 7.5% (p<.0001) Asymptomatic Stroke rate 0.9% vs. 1.8% (p<.0001) Mortality rate 0.36 vs 0.44%(p=.36) McPhee JT, Hill JS, Ciocca RG, et al: Carotid endarterectomy was performed with lower stroke and death rates than carotid artery stenting in the United States in 2003 and J Vasc Surg 2007; 46:

6 Carotid Artery Stenting Current Recommendations: CAS preferred Recurrent stenosis Neck immobility High carotid bifurcation Contralateral occlusion High surgical risk Severe cardiac or pulmonary disease CAS recommended Previous neck radiation Radical neck surgery Tracheostomy (GRADE 2, Level of Evidence B). CEA is preferred over CAS in patients who are over 70 years of age (grade I, level of evidence A) 1. Ricotta JJ et al. Updated Society for Vascular Surgery guidelines for management of extracranial carotid disease. J Vasc Surg 2011; 54:e1-e31 2. Halperin et al ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.Catheter Cardiovasc Interv Jan 1;81(1):E

7 CAS Long term data ICSS (UK) Compared long-term rate of fatal or disabling stroke in symptomatic patients randomly assigned to CAS or CEA.(n=1713) Primary outcome: Cumulative 5-year risk Fatal or disabling stroke 6.4% CAS vs. 6.5% CEA, (p = NS) Secondary outcome: 5 year restenosis( 70%) : 10.8% CAS and 8.6% CEA, (p= NS) 1. Featherstone RL et al. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (ICSS): a randomised controlled trial with cost-effectiveness analysis. Health Technol Assess 2016;20(20).

8 CAS Long term data CREST (USA) Compared long-term rate of periprocedural stroke, MI or death and subsequent ipsilateral stroke in all patients randomly assigned to CAS or CEA (n=2502) Primary Outcome Cumulative 10-year risk Fatal or disabling stroke 11.8% CAS vs. 9.9% CEA, (p = NS) Secondary Outcome 10-year restenosis( 70%): 12.2% CAS vs. 9.7% CEA, (p=ns) Caveats: Embolic protection was optional One stent used (RX acculink) 1. Featherstone RL et al. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (ICSS): a randomised controlled trial with cost-effectiveness analysis. Health Technol Assess 2016;20(20). 2. Brott R et al. Long-Term Results of Stenting versus Endarterectomy for Carotid-Artery Stenosis. N Engl J Med 2016;374:

9 Why Does Patency Matter? In the US, for persons 65 years of age, life expectancy is estimated to be 18 years for men 20 years for women Arias E. United States life tables, 2010.Nat Vital Stat Rep 2014; 63: 1-63.

10 What about stent design? Closed cell=struts interconnected Open cell=struts not interconnected Open cell preferred in carotid artery more conformable, less kinking A free cell area lower than 2.5 mm 2 showed superiority for all and post-procedural events (symptomatic pts) M. Bosiers. Does free cell area influence the outcome in carotid artery stenting?eur J Vasc Endovasc Surg Feb;33(2):135-41

11 Carotid Stenting Technique Approach Transfemoral Transcervical Embolic protection Filter Balloon occlusion Flow reversal

12 Latest innovation on carotid stenting

13 TCAR Carotid stenting available for >15yrs so what s new? Concepts Flow Reversal Old Concept with new spin low resistance AV circuit (carotid artery to femoral vein) 2004 carotid artery to IJ 1,2 Replaces previously FDA-approved flow reversal systems with balloon occlusion of the ECA and CCA (risk of embolization) Avoidance of transfemoral access/arch navigation Significant reduction in embolization 1. Chang DW. A new approach to carotid angioplasty and stenting with transcervical occlusion and protective shunting: Why it may be a better carotid artery intervention. J Vasc Surg May;39(5): Criado E et al. Transcervical carotid stenting with internal carotid artery flow reversal: Feasibility and preliminary results. J Vasc Surg 2004;40:476-83

14 TCAR ENROUTE Transcarotid Neuroprotection and Stent System ROADSTER Clinical Trial (prospective multicenter) FDA Conclusion: 208 pts approved at 18 sites stroke September rates in high-surgical 2016: Centers 75% asymptomatic 70% risk 25% symptomatic patients participating are 50% the lowest in the to date VQI for TCAR CAS 47% >75 and Surveillance years comparable of age Project with approved for periprocedural All reimbursement High Risk for CEA rates by in standard the Centers surgical for Medicare risk patients and for Medicaid CEA Services (CMS) under the current National Coverage Determination Results: Stroke 1.4% (vs. standard risk in CREST 4.1%) Stroke/Death 2.8% (vs. standard risk in CREST 4.8%) CNI 0.7% (vs. CEA 6%) MI 0.7% (0% for local anesthesia) (vs. standard risk 1.1% CREST) Kwolek CJ. Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal. J Vasc Surg 2015;62:

15 TCAR Candidates **Based on CMS criteria

16 TCAR Procedure Direct Carotid Access Femoral Vein Access

17 Stony Brook s Experience October 2016-January high risk patients (26 male and 19 female) 42 asymptomatic, 3 symptomatic Age of 75 years (61-86) Carotid stenosis 87.1% (60-95) Duplex PSV of 489.6cm/s ( cm/s) Duplex EDV of 130.3cm/s (42-314cm/s) Complications 1 patient- postop watershed infarct due to hypotension Mean LOS 1.1 days At 1-month follow-up. All patients had patent carotid stents with no neurologic deficits

18 Case: 62yo M symptomatic with amaurosis fugax and >90% occlusion

19 Case: 62yo M with >90% recurrent stenosis, asymptomatic

20 Conclusions Current guidelines suggest CAS is reserved for defined indications. With the advent of a novel spin (TCAR) on a traditional theory (flow reversal) the safety and durability of CAS may result in a paradigm shift!

21 Thank You!