John RolloClinical Assistant Professor

University of Washington Vascular Surgery6/15/2018

Trans-Carotid Artery Revascularization

How I do it

DISCLOSUREJohn Rollo, MD, RPVI

• Consultant / Advisory Board: Silk Road Medical• Speakers Bureau: Silk Road Medical

A Victim of the Endovascular Revolution

Leaded goggles

Lead shield

Lead gown

Sweaty brow

What about cerebrovascular disease?

What about cerebrovascular disease?

• Over 135,000 carotid artery revascularizations per year

• 90% are performed on asymptomatic disease

• 11% are catheter-based interventional procedures

Choice of revascularization

• Carotid Endarterectomy (CEA) is safe and effective• Carotid artery stenting (CAS) has some advantages

Choice of revascularization

• Some lesions are challenging to treat with CEA• High ICA lesions Above C2

• Higher risk anatomical• Prior neck dissection (redo CEA)• Radiation• Contralateral ICA disease or occlusion• Contralateral laryngeal nerve injury• Tracheostomy

Trans-Femoral carotid stenting

• Lesion must be crossed before embolic protection is in place

• Elderly (age >75) - Arch anatomy

Strong correlation between age and aortic arch ROC (R2=0.60, p<0.0001)

D eR ubertis et al. SVS A nnual M eeting 2013

Trans-Femoral carotid stenting

Trans-Carotid artery revascularization (TCAR) for high-risk carotid stenosis

VASCULAR AND ENDOVASCULAR SURGERY

2 weeks4 weeks

Who is a TCAR candidate?

Symptomatic high surgical risk with cervical carotid stenosis > 70%

Standard CMS coverage for CAS:

Who is a TCAR candidate – Requires registry data entry

• Age ≥ 75• CHF, EF ≤ 35%• ≥ 2 diseased coronaries• Unstable angina• MI within 6 weeks• Abnormal stress test• Need for open heart surgery• Need for major surgery

(including vascular)• Uncontrolled DM• Severe Pulmonary disease

• Prior head or neck surgery• Prior neck radiation• Restenosis s/p CEA• Surgically inaccessible lesion• Laryngeal palsy• Contralateral CN injury• Contralateral ICA occlusion• Tandem lesions• Bilateral stenosis needing

treatment.

Physiologic high risk Anatomic high risk

Symptomatic with cervical carotid stenosis > 50% ; Asymptomatic > 80% and one of the following:

Relative contraindications:

• Clavicle to carotid bifurcation distance < 5cm

• Heavy calcium and plaque burden in the CCA

• Stenosis or occlusion of CCA• Surgically inaccessible CCA

Anatomy

Who is a TCAR candidate?

How I Do it: Patient selection

1. Everyone gets a CTA head + neck

a. CCA origin evaluationb. Intracranial collateralizationc. Tortuosity and accessibility of CCAd. Accurate clavicle – CCA distance

2. Avoid heavy CCA disease3. Assess anesthesia risk

a. If low risk for GA and open contralateral ICA, do it4. Be wary of severe COPD

a. Pneumothorax is a risk!5. Recent stroke, tolerance of flow reversal

How I Do it: Pre-operative management

1. Everyone gets dual anti-platelet + statin (minimum 5d pre-op) - Including ASA+Plavix morning of procedure

2. If on anticoagulation, hold prior to operation +/- bridge.

3. Standard pre-surgical preparation and labs4. Medical pre-op evaluation for high risk

medical patients. 5. Thorough neurovascular exam

How I Do it: Intra-operative management

1. Hybrid OR team

2. Standard CEA neck prep + bilateral groin prep

3. Propofol sedation for cut-down portion with local anesthesia +/- Cervical block

4. Keep a chest tube set up ready

5. TCAR time-out prior to CCA access- Adequately heparinized ACT > 250- BP elevated - Glycopyrrolate 0.2mg IV- Neuro checks

Video!

Video!

How I Do it: Intra-operative management

6. Limited initial cervical angiogram- confirm lesion, ICA patency- mark the screen for sheath delivery

7. Insert sheath under fluoro- Stabilize the stiff wire and distal CCA- negative traction on the CCA with umbi tape

8. Initiate “passive” flow reversal and perform definitive cervical and intracranial angiograms

9. Clamp proximal CCA- repeat neuro checks- check flow reversal

How I Do it: Intra-operative management

10.Pre-dilate with a 3-4mm rapid exchange balloon

11.Stent – sized to the CCA. - Enroute self-expanding open cell non-

tapered- Err on the side of too long - cover the external if needed

12. Post dilate if needed (typically 5mm)

13. One minute of flow reversal

How I Do it: Intra-operative management

14. Repeat cervical angiogram15. Unclamp. Repeat intracranial angiograms16. Neuro checks17. Reverse heparin18. Close platysma, skin. No drain

How I Do it: Post-operative management

1. ICU overnight2. Arterial line with BP control3. ASA + Plavix + Statin4. Discharge POD 1

Roadster 2: Clinical Trial

1. Single arm, prospective observational study2. 600 patients to be enrolled.

- 70% of enrollees at new sites from R13. Inclusion: Asymptomatic > 80% stenosis,

Symptomatic > 50% stenosis with at least one

high risk criteria. Life expectancy > 3 years4. Exclusion: stroke in evolution, proximal

carotid stenosis or prior stent, alternative source of cerebral embolus (Afib).

Parameter n=486Age ≥75 41.4%Female 33.7%

Symptomatic 24.9%Both Physiologic & Anatomic Risk Factors 26.8%Top 3 Physiologic Risk FactorsAge ≥ 75 Years (17.9% as sole criterion)Hx of CAD (≥2 vessel disease)COPD

42.0%14.7%5.6%

Top 3 Anatomic Risk FactorsHigh Cervical StenosisRestenosis after CEAHostile Neck

25.4%20.0%17.0%

Roadster 2: High Risk Criteria

Parameter ROADSTER 1n=219

ROADSTER 2n=486

ROADSTER 1 Operators 100% 17.9%New TCAR Operators 76.2% 82.1%

Enrollment by New Operators

65.3% 70.0%

Skin-to-Skin Time (median) 70 mins 69 mins

Reverse Flow/Clamp Time (median)

9 mins 9 mins

Tolerance to High Flow 98.6% 98.6%

Tolerance to Low Flow 100% 100%

Roadster 2: Procedure Details

ROADSTER 1 ROADSTER 2

n=203 n=486

Stroke/Death/MI6 3.0% 6 1.4%

Stroke 1 0.5% 3 0.7%

Death2 1.0% 1* 0.2%

MI3 1.5% 2 0.5%

Stroke/Death 3 1.5% 4 0.9%

Neurological Death0 0.0% 0 0.0%

CNI (permanent)0 0.0% 0 0.0%

Roadster 2: Results in Surgical High Risk Patients

Conclusions

• TCAR provides a safe and effective method to treat symptomatic and asymptomatic patients with high grade stenosis who are at high risk for CEA

• Direct carotid access with high rate flow reversal allows for treatment of patients traditionally at increased risk for CAS (symptomatic, age ≥75)

Study PopulationPatients with atherosclerotic extracranial internal carotid stenosis (ICA) with or without involvement of the contiguous common artery (CCA) determined by duplex ultrasound, CT/CTA, MR/MRA or angiography to be:Symptomatic: greater than or equal to 50% stenosis orAsymptomatic: greater than or equal to 80% stenosisCriteriaINCLUSION CRITERIA:Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis:Symptomatic: Stenosis must be >50% as determined by an angiogram and the patient has a history of stroke (minor or non-disabling; NIHSS ≤4 or mRS≤2), TIA and/or amaurosis fugax within 180 days of the procedure procedure ipsilateral to the carotid artery to be stented.OR Asymptomatic: Stenosis must be >80% as determined by angiogram without any neurological symptoms within the prior 180 days.Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and ENROUTE Stent System (refer to IFU for requirements).Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).Patient is ≥18 years of age.Patient understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Institutional Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.Patient must have a life expectancy ≥ 3 years at the time of the index procedure without contingencies related to other medical, surgical or endovascular intervention.Patient meets at least one of the surgical high-risk criteria listed below.Anatomic High Risk Inclusion Criteria:A. Contralateral carotid artery occlusion B. Tandem stenoses >70% C. High cervical carotid artery stenosis D. Restenosis after carotid endarterectomy E. Bilateral carotid artery stenosis requiring treatment within 30 days after index treatment.F. Hostile Necks which the Investigator deems safe for transcarotid access including but not limited to:I. Prior neck irradiation II. Radical neck dissection III. Cervical spine immobilityClinical High Risk Inclusion Criteria:G. Patient is > 75 years of age H. Patient has > 2-vessel coronary artery disease and history of angina of any severity I. Patient has a history of anginaCanadian Cardiovascular Society (CCS) angina class 3 or 4 orunstable anginaJ. Patient has congestive heart failure (CHF) - New York Heart Association (NYHA)Functional Class III or IVK. Patient has known severe left ventricular dysfunctionLVEF <30%.L. Patient has had a myocardial infarction > 72 hours and < 6 weeks prior to procedure.M. Patient has severe pulmonary disease (COPD) with either:FEV1 <50% predicted orchronic oxygen therapy orresting PO2 of <60 mmHg (room air)N. Patient has permanent contralateral cranial nerve injury O. Patient has chronic renal insufficiency (serum creatinine > 2.5 mg/dL).REMINDER: The following is a list of anatomical considerations that are not suitable for transfemoral CAS with distal protection that are NOT contraindications for enrollment in the ROADSTER 2 Study including but not limited to:I. TypeII, III, or Bovine arch II. Arch atheroma or calcification III. Atheroma of the great vessel origins IV. Tortuous distal ICA V. Tortuous or occluded iliofemoral segments VI. Occluded aortoiliac segmentsEXCLUSION CRITERIA:Each potential patient must be screened to ensure that they do not meet any of the following exclusion criteria. This screening is to be based on known medical history and data available at the time of eligibility determination and enrollment.Patient has an alternative source of cerebral embolus, including but not limited to:

Patient has chronic atrial fibrillation.Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.Knowledge of cardiac sources of emboli. e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma).Recently (<60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram.Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by angiography or CTA/MRA ≤ 6 months prior to index procedure) greater in severity than the lesion to be treated, cerebral aneurysm > 5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings.

Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, or has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure.Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.Patient with a history of major stroke attributable to either carotid artery (CVA or retinal embolus) with major neurological deficit (NIHSS ≥ 5 OR mRS≥ 3) likely to confound study endpoints within 1 month of index procedure.Patient has an intracranial tumor.Patient has an evolving stroke.Patient has neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke, including but not limited to: moderate to severe dementia, partial or secondarily generalized seizures, complicated or classic migraine, tumor or other space-occupying brain lesions, subdural hematoma, cerebral contusion or other post-traumatic lesions, intracranial infection, demyelinating disease, or intracranial hemorrhage).Patient has had a TIA or amaurosis fugax within 48 hrs prior to the procedure.Patient has an isolated hemisphere.Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention.Myocardial Infarction within 72 hours prior to the intervention.Presence of a previous placed intravascular stent in target vessel or ipsilateral CCA or significant CCA inflow lesion.Occlusion or [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm of the ipsilateral common or internal carotid artery.An intraluminal filling defect (defined as an endoluminal lucency surrounded by contrast, seen in multiple angiographic projections, in the absence of angiographic evidence of calcification) whether or not it is associated with an ulcerated target lesion.Ostium of Common Carotid Artery (CCA) requires revascularization.Patient has an open stoma in the neck.Female patients who are pregnant or may become pregnant.Patient has history of intolerance or allergic reaction to any of the study medications or stent materials (refer to stent IFU), including aspirin (ASA), ticlopidine, clopidogrel, statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine or ASA and clopidogrel.Patient must have a life expectancy <3 years without contingencies related to other medical, surgical, or interventional procedures as per the Wallaert Score and patients with primary, recurrent or metastatic malignancy who do not have independent assessment of life expectancy performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.

Appendix A: Roadster 2 inclusion/exclusion

Exclusion Criteria for TCAR ROADSTER 1 trial

• Afib; recent valve or MI; bleeding• Evolving stroke; neuro disorders• Occlusion; ostial CCA or intracranial stenosis;

string sign; previous stent• CCA disease at entry site• <5cm clavicle to bifurcation

Appendix B: Roadster 1

1. Ricotta, J.J., Aburahma, A., Ascher, E., Eskandari, M., Faries, P., Lal, B.K., and Society for Vascular Surgery. Updated Society for Vascular Surgery guidelines for management of extracranial carotid disease. ([Erratum in: J Vasc Surg2012;55:894])J Vasc Surg. 2011; 54: e1–e31

2. North American Symptomatic Carotid Endarterectomy Trial Collab- orators (NASCET). Beneficial effect of carotid endarterectomyin symptomatic patients with high-grade carotid stenosis. North Ameri- can Symptomatic Carotid Endarterectomy Trial Collaborators N Engl J Med 1991;325:445. 3. Barnett HJ, Taylor DW, Eliasziw M, Fox AJ, Ferguson GG, Haynes RB, et al. Benefit of carotid endarterectomy in patients with symptom- atic moderate or severe stenosis. North American Symptomatic Ca- rotid Endarterectomy Trial Collaborators. N Engl J Med 1998;339: 1415-25. 4. Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST). Lancet 1998;351:1379-87.5. J Vasc Surg. 2011 Nov;54(5):1317-23. doi: 10.1016/j.jvs.2011.04.040. Epub 2011 Jun 12.6. Kwolek CJ, Jaff MR, Leal JI, Hopkins LN, Shah RM, Hanover TM, Macdonald S, Cambria RP. Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal. J Vasc Surg. 2015 Nov;62(5):1227-34. doi: 10.1016/j.jvs.2015.04.460. PubMed PMID: 26506270.

References