SVS VQI TransCarotid Revascularization Surveillance Project
SVS VQI TransCarotid Revascularization Surveillance Project
The VQI TCAR Surveillance Project is designed to monitor the safety and effectiveness of
 stents placed directly into the carotid artery while reversing blood flow within the carotid
 artery to reduce stroke risk. It will compare this less-invasive surgical procedure with
 standard carotid endarterectomy in centers that participate in the Society for Vascular
 Surgery Vascular Quality Initiative.
Background:

 Contemporary randomized trials of transfemoral carotid artery stenting (TF CAS) and carotid
 endarterectomy (CEA) have shown comparable long-term ipsilateral stroke prevention (>30 days)
 but have consistently demonstrated higher periprocedural (< 30 day) stroke rates, including
 contralateral stroke, compared with CEA, with the highest risk centered around "day zero".
 Potential etiologies for this excess risk likely relate to embolization during unprotected
 catheterization of the aortic arch and supraaortic vessels from a TF approach and/or
 suboptimal distal embolic protection during CAS. TransCarotid Artery Revascularization (TCAR)
 combines the surgical principles of neuroprotection with minimally invasive endovascular
 techniques to treat stenosis in the carotid artery. It involves surgical exposure and
 clamping of the proximal common carotid artery with continuous carotid blood flow reversal
 via an extracorporeal arteriovenous shunt from the target carotid artery to a femoral vein,
 during which carotid bifurcation/internal carotid artery stenting is performed. Thus, TCAR
 avoids catheter manipulation in the aortic arch and emulates the "clamp and backbleed" method
 of neuroprotection during CEA, but differs from CEA in that the carotid artery is accessed
 through a smaller, supra-clavicular incision below the main plexus of cranial nerves.
 Further, the direct transcarotid approach allows the use of larger bore sheaths and tubing to
 achieve higher reverse carotid artery flow rates than is possible with smaller transfemoral
 catheters.

 Published TCAR Data:

 The initial study of TCAR in patients deemed to be at high risk for complications from CEA
 have shown that TCAR appears to provide superior stroke and death outcomes when compared to
 prior registry results from both CEA and TF CAS. Schermerhorn, et al reported outcomes from
 the Society for Vascular Surgery (SVS) Vascular Registry in high surgical risk patients and
 found that in this real world registry, the 30-day stroke and death rates in symptomatic
 patients for CEA and TF CAS were 6.4% and 7.9% respectively. (Citation: Schermerhorn) In
 asymptomatic, high risk patients, the 30-day stroke and death rates for CEA and TF CAS were
 3.7% and 4.8% respectively. In contrast, a recent study of TCAR (ROADSTER pivotal trial) ,
 the 30-day stroke and death rates for both symptomatic and asymptomatic patients were 2.8%
 and 2.9%, respectively. (Citation: Kwolek) While these initial results of TCAR are
 encouraging, they involved only 114 patients in the pivotal trial, such that further
 evaluation is clearly important.

 Objective:

 The objective of the VQI TransCarotid Artery Revascularization Surveillance Project is to
 evaluate the safety and effectiveness of TCAR in real world practice, using a contemporaneous
 comparison with CEA. Stroke and death outcomes data in TCAR and CEA patients deemed to be at
 high risk for complications from CEA will be collected and analyzed using the SVS PSO CAS and
 CEA Registries. High surgical risk is defined according to the CMS criteria published in the
 National Coverage Determination for Percutaneous Transluminal Angioplasty (20.7) and listed
 in the inclusion criteria. The evaluation of these alternate strategies for surgical
 treatment of carotid artery disease is central to the mission of the SVS PSO.

 Methods:

 All high surgical risk patients treated with TCAR and CEA in the SVS PSO CAS and CEA
 Registries will be included and separately analyzed as symptomatic and asymptomatic, with
 symptomatic defined as a history of ipsilateral stroke, TIA and/or amaurosis fugax within 180
 days of the procedure. 30-day and one-year outcomes will be analyzed in propensity matched,
 risk adjusted cohorts. Any FDA-cleared proximal embolic protection device and FDA-approved
 carotid artery stent system indicated for the transcarotid approach will be included in the
 registry. Sites participating in VQI are audited for consecutive case submission by
 comparison with claims data. A Steering Committee within the SVS PSO will monitor the quality
 and completeness of submitted data, and adjudicate any questionable outcomes by querying
 sites for clarifying information. This committee will be responsible for scientific analysis
 and periodic publication of the results.
Inclusion Criteria:

 Patients undergoing TCAR or CEA who are considered high surgical risk as defined by the CMS
 criteria published in the National Coverage Determination for Percutaneous Transluminal
 Angioplasty (20.7). Any of the following criteria qualify a patient for inclusion in the
 high surgical risk TCAR or CEA cohort:

 Anatomic High Risk Inclusion Criteria:

 -  Contralateral carotid artery occlusion

 -  Tandem stenoses >70%

 -  High cervical carotid artery stenosis

 -  Restenosis after carotid endarterectomy

 -  Bilateral carotid artery stenosis requiring treatment

 -  Hostile neck which the Investigator deems safe for transcarotid access including but
 not limited to prior neck irradiation, prior radical neck dissection or cervical spine
 immobility

 Clinical High Risk Inclusion Criteria:

 -  Patient is >= 75 years of age

 -  Patient has >= 2-vessel coronary artery disease and history of angina of any severity

 -  Patient has a history of unstable angina or Canadian Cardiovascular Society (CCS)
 angina class 3 or 4

 -  Patient has congestive heart failure (CHF) - New York Heart Association (NYHA)
 Functional Class III or IV

 -  Patient has known severe left ventricular dysfunction with LVEF <30%.

 -  Patient has had a myocardial infarction > 72 hours and < 6 weeks prior to procedure.

 -  Patient has severe pulmonary disease (COPD) with either FEV1 <50% predicted or chronic
 oxygen therapy or resting PO2 of <= 60 mmHg (on room air)

 -  Patient has permanent contralateral cranial nerve injury

 -  Patient has chronic renal insufficiency (serum creatinine > 2.5 mg/dL).

 Exclusion Criteria:

 -  Patients undergoing TCAR or CEA who do not meet at least one of the above inclusion
 criteria, plus patients who have received a previous stent in the target artery.