- Email: [email protected]
Transcervical Carotid Artery Stenting Using a Prosthetic Arterial Conduit: Case Series of a Novel Surgical Technique
Accepted Manuscript Transcervical Carotid Artery Stenting Using a Prosthetic Arterial Conduit: Case Series of a Novel Surgical Technique Nandakumar Menon, MD, Ali Khalifeh, MD, Charles B. Drucker, MD, Suny Sahajwani, MD, Danon Garrido, MD, Richa Kalsi, BS/BA, Brajesh K. Lal, MD, Shahab Toursavadkohi, MD PII:
S0890-5096(17)30075-4
DOI:
10.1016/j.avsg.2017.06.039
Reference:
AVSG 3434
To appear in:
Annals of Vascular Surgery
Received Date: 19 January 2017 Revised Date:
12 April 2017
Accepted Date: 5 June 2017
Please cite this article as: Menon N, Khalifeh A, Drucker CB, Sahajwani S, Garrido D, Kalsi R, Lal BK, Toursavadkohi S, Transcervical Carotid Artery Stenting Using a Prosthetic Arterial Conduit: Case Series of a Novel Surgical Technique, Annals of Vascular Surgery (2017), doi: 10.1016/j.avsg.2017.06.039. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Transcervical Carotid Artery Stenting Using a Prosthetic Arterial Conduit: Case Series of a Novel Surgical Technique
4 5 6 7 8
Nandakumar Menon, MD,1 Ali Khalifeh, MD,1 Charles B. Drucker, MD,1 Suny Sahajwani, MD,2 Danon Garrido, MD,1 Richa Kalsi, BS/BA,1 Brajesh K. Lal, MD,1 Shahab Toursavadkohi, MD1
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Division of Vascular Surgery, Department of Surgery, University of Maryland School of Medicine, Baltimore, MD
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Correspondence to:
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Shahab Toursavadkohi, MD Division of Vascular Surgery Department of Surgery University of Maryland School of Medicine 22 S. Greene St., S10B00 Baltimore, MD USA 21201 Email: [email protected] Office: (410) 328-5840
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Keywords: Carotid artery stenosis; carotid disease; stenting; carotid artery stenting; atherosclerotic disease.
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Counts: Abstract: 100 words. Main text: 1,930 words. 2 tables, 4 figures.
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Department of Surgery, Union Memorial Hospital, Baltimore, MD
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1. Abstract
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We present a series of 4 patients with carotid restenosis following carotid endarterectomy (CEA)
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who underwent transcervical carotid artery stenting (CAS) using a novel prosthetic conduit
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technique. The patients were high risk for repeat CEA (short and obese necks) and had
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contraindications to transfemoral CAS (Bovine arch, prior dissection). Carotid artery stenting
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was thus performed via a transcervical approach with a polytetrafluoroethylene (PTFE) conduit
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anastomosed to the proximal common carotid artery (CCA). The addition of a conduit allowed
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stent placement via a secure, stable platform. All patients recovered from their procedure without
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incident and are free from restenosis at follow-up.
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2. Introduction
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Carotid artery stenting (CAS) has emerged as an alternative to carotid endarterectomy (CEA)
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especially in the setting of carotid restenosis following CEA and in high risk patients.1,2 CAS is
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traditionally performed via a percutaneous femoral access technique, but anatomic
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considerations can make this unfeasible.3 Diseased or occluded iliofemoral arteries, Type III or
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bovine arches, severe arch atheroma, and prior aortic, cervical, and iliofemoral procedures can
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complicate access and increase the embolization burden.4,5
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Recent studies have shown that CAS performed through a transcervical access may produce a
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reduced embolic load compared to transfemoral access.5 While the rate of stroke following CAS
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is low—4.1% in the CREST trial and 6.5% in a subsequent meta-analysis—the rate of stroke
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with transcervical access is reported at about 1%.5–7 This technique has a reported 96.3%
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technical success rate and a 0.4% death rate. For these reasons, it may be an attractive alternative
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to transfemoral CAS.5
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TransCarotid Artery Stenting (TCAR) is still dependent upon the presence of favorable neck
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anatomy. In our experience, patients with constrained neck anatomy can make safe access to and
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control of the CCA challenging. Short, thick necks and scarring from prior CEA can limit the
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space available for manipulation of endovascular devices. The exchange and manipulation of
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wires, sheaths, and stent devices is severely restricted when the distance from the plaque to the
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arterial puncture is short. Even routine exchanges risk loosening plaque for later embolization or
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inducing a dissection.
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To overcome these challenges, we modified the TCAR procedure by adding a prosthetic arterial
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conduit. This technique has a demonstrated record of safety in other endovascular procedures
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such as iliac artery prosthetic conduits for aortic endograft delivery, and requires no special
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training or devices. We believe that this provides a stable access route for CAS that would
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provide sufficient room to maneuver even in the setting of constrained neck anatomy.
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3. Surgical Approach
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General anesthesia was used for all procedures. The neck and chest on the appropriate side were
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prepped and draped and an arterial line was placed in the contralateral radial artery. An oblique
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incision was made in virgin territory at the base of the neck. Dissection was carried to the
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sternocleidomastoid, which was retracted laterally. The vagus nerve and internal jugular vein
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were identified and preserved. A 3-4 cm segment of the CCA was exposed (Figure 1A).
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Following systemic heparinization, the CCA is controlled with proximal and distal vessel loops
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and clamps and a longitudinal arteriotomy is performed. A 6-mm polytetrafluoroethylene (PTFE)
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conduit was anastomosed to the CCA in end to side fashion (Figure 1B). In cases with a steep
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angle at the clavicle, the proximal end of the graft was tunneled and brought out through a
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counter incision on the anterior chest wall. The free end of the conduit was secured with a
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Rummel tourniquet and, with the patient in Trendelenberg, the conduit was de-aired and flushed
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with heparin-saline. A 6 French sheath was advanced into the conduit to provide a stable
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platform for embolic protection device (EPD) and stent deployment (Figure 2). We established a
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roadmap with an antegrade angiogram (Figure 3A) and the EPD (Nav-6 filter, Abbott Vascular,
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Menlo Park, CA) was deployed under fluoroscopic guidance. An appropriately sized self-
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expanding stent (Exact, Abbott Vascular, Menlo Park, CA) was deployed across the lesion and
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completion angiography confirmed resolution of the lesion (Figure 3B). The EPD, wires, and
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sheaths were removed. The conduit was transected close to the surface of the CCA and sutured
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closed transversely to prevent narrowing, effectively creating a patch angioplasty. The platysma,
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subcutaneous tissue, and skin were closed and the patient was recovered from anesthesia. Duplex
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ultrasonography at outpatient follow up confirmed normal flow at the CCA and a well apposed
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stent in each case (Figure 4).
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4. Results
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All patients had high comorbidity burdens but tolerated their procedures well. Patient baseline
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characteristics are outlined in Table 1.
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Patient 1 was an 83-year-old male who was being followed after bilateral carotid
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endarterectomies. Critical restenosis (>90%) of the left CCA was found immediately inferior to
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the prior endarterectomy. Transfemoral CAS was attempted but significant tortuosity and a
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bovine arch precluded access. This patient underwent transcervical CAS via an arterial conduit
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as described above. Completion angiogram showed complete resolution of the lesion. A duplex
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ultrasound (DUS) 17 days after surgery showed no residual stenosis. The patient has been
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followed for 7 months without adverse events or recurrent stenosis on duplex.
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Patient 2 was a 64-year-old female who initially presented for a symptomatic type B aortic
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dissection, which was treated with thoracic endovascular aortic repair through a left common
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iliac conduit due to very small native external iliac arteries. During her initial stay, she was
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screened with duplex for associated carotid dissection and found to have stenosis of 80-99%. She
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underwent CEA but experienced restenosis on follow-up over the subsequent year. Computed
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tomographic angiography (CTA) demonstrated high-grade restenosis with string sign. Given the
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complexity of repeat iliac access and a heavy burden of plaque in the arch, we performed
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transcervical CAS with a conduit. At 3 months of follow up, duplex showed increased velocities
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distal to the stent representing <50% stenosis but no stenosis at the conduit site.
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Patient 3 is a 75-year-old female with a prior left CEA who presented with asymptomatic
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recurrent stenosis of 80-99% stenosis on magnetic resonance angiography as well as a type 3 and
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bovine aortic arch. She had thick scarring at her CEA site. Given the re-operative field and her
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complex arterial anatomy, she underwent a transcervical CAS with conduit. DUS 7 days
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postoperatively showed no significant stenosis. At 3 months follow up she continues to do well
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without recurrent stenosis on duplex.
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Patient 4 was a 73-year-old male with a prior right CEA 12 years ago. Interval CTA showed
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restenosis exceeding 90% as well as a complex ulcerated calcific lesion in the wall of the
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proximal right ICA that was concerning for a limited dissection. Transfemoral CAS was
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attempted but unsuccessful due to significant tortuosity of his bovine arch. Transcervical CAS
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with conduit was performed as described and completion angiogram showed complete resolution
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of the stenosis and coverage of the dissection. The patient tolerated the procedure well and was
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discharged after overnight monitoring. On follow up at 6 weeks, DUS showed no evidence of
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stenosis and he was free of adverse events.
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Overall, all patients in our small series did well following their procedure and did not experience
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major adverse outcomes, as outline in Table 2.
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5. Discussion
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The incidence of restenosis after CEA have been reported to be between 6% and 22%.8–10 A
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secondary analysis of Carotid Revascularization Endarterectomy vs Stenting Trial (CREST)
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reported a restenosis rate of 6.3% at 2 years and associated it with clinically significant increased
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risk of stroke when recurrent stenosis is >70%.11 For the management of such lesions, most
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studies show a higher rate of cranial nerve injuries and one recently published study from
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Vascular Quality Initiative data described higher mortality in high risk patients with redo CEA
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compared to CAS.12 CAS is a better alternative as CEA is also associated with increased
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incidence of cranial nerve injuries and wound complications.13,14
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Transcervical CAS has been reported as a safer alternative to transfemoral CAS in certain high
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risk populations.5 The transcervical approach allows surgeons to bypass difficult arch anatomy,
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improve the technical feasibility of CAS and may reduce the perioperative stroke rate. Our
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technique goes one step beyond direct puncture by eliminating of the requirement for several
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centimeters of sheath within the common carotid artery. The sheath may be positioned almost
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entirely within the conduit itself while still providing a stable platform with abundant room for
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maneuvering of wires and devices. By adding effective maneuver length, the surgeon is able to
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treatment of even proximal lesions in patients with short necks or with tortuous carotid anatomy,
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where it might otherwise be difficult to safely pass through the region of stenosis. The long
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sheaths used in this technique were seen as an advantage given the ability of the surgeon to use
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this access method without acquiring additional new or specialized equipment. The technique
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works just as well with shortened sheaths, wires, and devices.
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While the use of a prosthetic conduit does require some additional exposure relative to
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conventional TCAR and the anastomosis is an additional step, the added complexity at this stage
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simplifies the manipulation of wires and catheters later on. The overall complexity is thus similar
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to TCAR without a conduit or conventional CAS. As all wire and catheter exchanges can be
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conducted with a greater effective distance between the sheath and the target lesion, control of
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the wire and sheath passage is excellent. Additionally, since most repeated manipulations occur
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either within the native vessel or within the conduit, this method could potentially reduce the risk
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of dissecting the accessed vessel due to exchanges through the wall of the CCA.
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In our case series of 4 patients with post-CEA restenosis and with difficult aorto-iliac, aortic arch
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or CCA anatomy, we safely treated them all with transcervical CAS via a 6-mm PTFE conduit
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anastomosed to the proximal common carotid artery. This provided a stable access route for
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stenting and manipulation of endovascular devices while avoiding complicating anatomy and
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prior scar tissue.
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The surgical approach of this novel method is a broadly applicable procedure that could be used
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by any trained vascular surgeon. By the addition of the PTFE conduit, the operator is able to
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perform the procedure via a long, stable platform. This technique allows the operator to traverse
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the lesion reliably and potentially reduces the risk of embolization during transfemoral CCA
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access. Transcervical access can be challenging with short thick necks. For this reason, we have
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found our technique adapts well to this constrained anatomy. This approach reduces the
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difficulty of the operation without altering traditional CAS techniques.
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The short-term outcomes of our case series have been positive with no evidence of
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atheroembolic stroke, cervical hematomas, or cranial nerve injuries during the perioperative and
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post-operative period. All our patients were discharged within 36 hours of the procedure. Our
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follow up, the longest of which was 7 months, also showed no signs of CCA
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bleeding/pseudoaneurysm/stenosis and no mortalities. One patient, who had early re-stenosis
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following CEA had some evidence of mild in-stent or distal ICA re-stenosis. While additional
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follow-up and validation is required, we believe that this is a promising means of overcoming
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specific anatomic limitations that preclude transfemoral CAS.
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This technique expands the options for the vascular surgeon treating a patient with restenosis
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following endarterectomy with complex proximal anatomy. While the anatomic variations that
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necessitate a transcervical approach are uncommon, they are not rare and require innovative
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solutions. We offer this technique to selected patients who have contraindications to more
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conventional interventions for carotid disease, who can avoid complex repeat endarterectomy
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procedures. The longer-term effects of the conduit stump are unknown, although long-term
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studies of PTFE patch angioplasty have shown favorable outcomes compared to other patch
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materials.15,16 Larger numbers of patients will ultimately be required to validate the safety and
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effectiveness of this technique as well as to evaluate longer-term outcomes.
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6. Conclusions
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We introduce transcervical carotid stenting through a prosthetic conduit as an alternative to
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traditional transcervical and transfemoral CAS. It has broad applications, requires no additional
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equipment or training for any vascular surgeon, has minimal additional cost associated with the
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technique. This approach can be utilized in situations with aorto-iliac occlusive disease, difficult
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aortic arch anatomy, or in the presence of sever CCA tortuosity where a short or obese neck can
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preclude direct and reliable transcervical access to the CCA.
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Funding: This research did not receive any specific grant from funding agencies in the public,
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commercial, or not-for-profit sectors. BKL is supported by grants from NINDS-NIH, NIA-NIH,
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VA CSR&D, VA RR&D, and SVS.
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Conflicts of Interest: The authors have no conflicts of interest to disclose.
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References:
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1.
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Hobson RW, Lal BK, Chaktoura E, Goldstein J, Haser PB, Kubicka R, et al. Carotid artery stenting: Analysis of data for 105 patients at high risk. J Vasc Surg [Internet]. 2003
213
Jun;37(6):1234–9. Available from: http://dx.doi.org/10.1016/S0741-5214(02)75448-7
214
2.
TE D
212
Yadav JS, Wholey MH, Kuntz RE, Fayad P, Katzen BT, Mishkel GJ, et al. Protected Carotid-Artery Stenting versus Endarterectomy in High-Risk Patients. N Engl J Med
216
[Internet]. 2004 Oct 7;351(15):1493–501. Available from:
217
http://dx.doi.org/10.1056/NEJMoa040127 3.
Wholey MH, Wu WCS. Current status in cervical carotid artery stent placement. J
221
AC C
218
EP
215
222
Oct;40(4):746–51; discussion 751. Available from:
223
http://dx.doi.org/10.1016/j.jvs.2004.07.021
Cardiovasc Surg (Torino). 2009 Feb;50(1):29–37.
219 220
224
4.
Choi HM, Hobson RW, Goldstein J, Chakhtoura E, Lal BK, Haser PB, et al. Technical challenges in a program of carotid artery stenting. J Vasc Surg [Internet]. 2004
5.
Sfyroeras GS, Moulakakis KG, Markatis F, Antonopoulos CN, Antoniou GA, Kakisis JD,
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225
et al. Results of carotid artery stenting with transcervical access. J Vasc Surg [Internet].
226
2013 Nov;58(5):1402–7. Available from: http://dx.doi.org/10.1016/j.jvs.2013.07.111
227
6.
Liu Z-J, Fu W-G, Guo Z-Y, Shen L-G, Shi Z-Y, Li J-H. Updated Systematic Review and Meta-Analysis of Randomized Clinical Trials Comparing Carotid Artery Stenting and
229
Carotid Endarterectomy in the Treatment of Carotid Stenosis. Ann Vasc Surg [Internet].
230
2012 May;26(4):576–90. Available from: http://dx.doi.org/10.1016/j.avsg.2011.09.009 7.
Brott TG, Hobson RW, Howard G, Roubin GS, Clark WM, Brooks W, et al. Stenting
SC
231
RI PT
228
versus Endarterectomy for Treatment of Carotid-Artery Stenosis. N Engl J Med [Internet].
233
2010 Jul;363(1):11–23. Available from: http://dx.doi.org/10.1056/NEJMoa0912321
234
8.
M AN U
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Keagy BA, Edrington RD, Poole MA, Johnson G. Incidence of recurrent or residual
235
stenosis after carotid endarterectomy. Am J Surg [Internet]. 1985;149(6):722–5. Available
236
from: http://dx.doi.org/10.1016/S0002-9610(85)80173-2 9.
Goodney PP, Nolan BW, Eldrup-Jorgensen J, Likosky DS, Cronenwett JL. Restenosis
TE D
237
after carotid endarterectomy in a multicenter regional registry. J Vasc Surg [Internet].
239
2010 Oct;52(4):897–904, 905-2-5. Available from:
240
http://dx.doi.org/10.1016/j.jvs.2010.05.005 10.
Surg [Internet]. 1997 Sep;84(9):1206–19. Available from:
242
http://dx.doi.org/10.1046/j.1365-2168.1997.02849.x
243 244 245
Lattimer CR, Burnand KG. Recurrent carotid stenosis after carotid endarterectomy. Br J
AC C
241
EP
238
11.
Lal BK, Beach KW, Roubin GS, Lutsep HL, Moore WS, Malas MB, et al. Restenosis after carotid artery stenting and endarterectomy: A secondary analysis of CREST, a
246
randomised controlled trial. Lancet Neurol [Internet]. 2012;11(9):755–63. Available from:
247
http://dx.doi.org/10.1016/S1474-4422(12)70159-X
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248
12.
Arhuidese I, Obeid T, Nejim B, Locham S, Hicks CW, Malas MB. Stenting versus
249
endarterectomy after prior ipsilateral carotid endarterectomy. J Vasc Surg [Internet]. 2017
250
Jan;65(1):1–11. Available from: http://dx.doi.org/10.1016/j.jvs.2016.07.115 13.
AbuRahma AF, Choueiri MA. Cranial and cervical nerve injuries after repeat carotid
RI PT
251 252
endarterectomy. J Vasc Surg [Internet]. 2000 Oct;32(4):649–54. Available from:
253
http://dx.doi.org/10.1067/mva.2000.109751 14.
Marques de Marino P, Martinez Lopez I, Hernandez Mateo MM, Cernuda Artero I,
SC
254
Cabrero Fernandez M, Reina Gutierrez MT, et al. Open Versus Endovascular Treatment
256
for Patients with Post-Carotid Endarterectomy Restenosis: Early and Long-term Results.
257
Ann Vasc Surg [Internet]. 2016 Oct;36:159–65. Available from:
258
http://dx.doi.org/10.1016/j.avsg.2016.02.027
259
15.
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AbuRahma AF, Robinson PA, Saiedy S, Kahn JH, Boland JP. Prospective randomized trial of carotid endarterectomy with primary closure and patch angioplasty with saphenous
261
vein, jugular vein, and polytetrafluoroethylene: long-term follow-up. J Vasc Surg
262
[Internet]. 1998 Feb [cited 2017 Mar 24];27(2):222-32-4. Available from:
263
http://www.ncbi.nlm.nih.gov/pubmed/9510277
266 267 268 269
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16.
Rerkasem K, Rothwell PM. Patches of different types for carotid patch angioplasty. In: Rothwell PM, editor. Cochrane Database of Systematic Reviews [Internet]. Chichester,
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UK: John Wiley & Sons, Ltd; 2010 [cited 2017 Mar 24]. Available from: http://doi.wiley.com/10.1002/14651858.CD000071.pub3
Figure Captions:
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Figure 1. Cervical common carotid access with A) isolation of CCA in virgin territory, B)
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anastomosis of PTFE conduit.
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Figure 2. Arrangement of conduit access with introducer sheath.
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Figure 3. Intraoperative angiography A) at start of case and B) post-stent.
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Figure 4. Postoperative duplex ultrasonography demonstrating laminar flow in the proximal
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common carotid around the site of the conduit anastomosis.
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Table 1: Patient demographics and baseline characteristics. Patient
Age Laterality Sex (y) & Stenosis
Restenosis Interval (y)
Comorbidities
83
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Left 80-99%
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HTN, Diabetes, ASA 3
2
65
F
Right 80-89%
0.8
HTN, Type B dissection s/p TEVAR, ASA 3
3
75
F
Left 71-99%
1.3
4
73
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Right 80-99%
Prior bilateral CEA, bovine arch, failed transfemoral access Prior right CEA, arch atherosclerotic plaque burden, poor femoral anatomy, prior left iliac access
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Complicating factors
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HTN, Diabetes, Prior left CEA, bovine GERD, HLD, ASA arch 3 Tobacco use, HTN, Prior right CEA, bovine Prior AVR and arch, failed transfemoral access CABG, ASA 3
7
HTN, hypertension; ASA, American Society of Anesthesiology score; CEA, carotid endarterectomy; TEVAR, thoracic endovascular aortic repair; GERD, gastroesophageal reflux disease, HLD, hyperlipidemia; AVR, aortic valve replacement; and CABG, Coronary artery bypass graft.
20
7
2
24
3
3
36
4
25
CVA or TIA
Hematoma
Cranial Nerve Injury
Conduit Site Stenosis
None
None
None
Not detected
None
None
None
Not detected
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Table 2: Patient outcomes. LOS Follow up Patient (hours) (months)
None
None
None
Not detected
3
None
None
None
Not detected
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LOS, Length of stay; CVA, cerebrovascular accident; TIA, transient ischemic attack.
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S0890-5096(17)30075-4
DOI:
10.1016/j.avsg.2017.06.039
Reference:
AVSG 3434
To appear in:
Annals of Vascular Surgery
Received Date: 19 January 2017 Revised Date:
12 April 2017
Accepted Date: 5 June 2017
Please cite this article as: Menon N, Khalifeh A, Drucker CB, Sahajwani S, Garrido D, Kalsi R, Lal BK, Toursavadkohi S, Transcervical Carotid Artery Stenting Using a Prosthetic Arterial Conduit: Case Series of a Novel Surgical Technique, Annals of Vascular Surgery (2017), doi: 10.1016/j.avsg.2017.06.039. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT 1
Transcervical Carotid Artery Stenting Using a Prosthetic Arterial Conduit: Case Series of a Novel Surgical Technique
4 5 6 7 8
Nandakumar Menon, MD,1 Ali Khalifeh, MD,1 Charles B. Drucker, MD,1 Suny Sahajwani, MD,2 Danon Garrido, MD,1 Richa Kalsi, BS/BA,1 Brajesh K. Lal, MD,1 Shahab Toursavadkohi, MD1
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Division of Vascular Surgery, Department of Surgery, University of Maryland School of Medicine, Baltimore, MD
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Correspondence to:
12 13 14 15 16 17 18 19 20 21 22 23
Shahab Toursavadkohi, MD Division of Vascular Surgery Department of Surgery University of Maryland School of Medicine 22 S. Greene St., S10B00 Baltimore, MD USA 21201 Email: [email protected] Office: (410) 328-5840
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Keywords: Carotid artery stenosis; carotid disease; stenting; carotid artery stenting; atherosclerotic disease.
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Counts: Abstract: 100 words. Main text: 1,930 words. 2 tables, 4 figures.
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Department of Surgery, Union Memorial Hospital, Baltimore, MD
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1. Abstract
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We present a series of 4 patients with carotid restenosis following carotid endarterectomy (CEA)
28
who underwent transcervical carotid artery stenting (CAS) using a novel prosthetic conduit
29
technique. The patients were high risk for repeat CEA (short and obese necks) and had
30
contraindications to transfemoral CAS (Bovine arch, prior dissection). Carotid artery stenting
31
was thus performed via a transcervical approach with a polytetrafluoroethylene (PTFE) conduit
32
anastomosed to the proximal common carotid artery (CCA). The addition of a conduit allowed
33
stent placement via a secure, stable platform. All patients recovered from their procedure without
34
incident and are free from restenosis at follow-up.
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2. Introduction
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Carotid artery stenting (CAS) has emerged as an alternative to carotid endarterectomy (CEA)
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especially in the setting of carotid restenosis following CEA and in high risk patients.1,2 CAS is
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traditionally performed via a percutaneous femoral access technique, but anatomic
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considerations can make this unfeasible.3 Diseased or occluded iliofemoral arteries, Type III or
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bovine arches, severe arch atheroma, and prior aortic, cervical, and iliofemoral procedures can
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complicate access and increase the embolization burden.4,5
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Recent studies have shown that CAS performed through a transcervical access may produce a
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reduced embolic load compared to transfemoral access.5 While the rate of stroke following CAS
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is low—4.1% in the CREST trial and 6.5% in a subsequent meta-analysis—the rate of stroke
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with transcervical access is reported at about 1%.5–7 This technique has a reported 96.3%
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technical success rate and a 0.4% death rate. For these reasons, it may be an attractive alternative
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to transfemoral CAS.5
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TransCarotid Artery Stenting (TCAR) is still dependent upon the presence of favorable neck
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anatomy. In our experience, patients with constrained neck anatomy can make safe access to and
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control of the CCA challenging. Short, thick necks and scarring from prior CEA can limit the
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space available for manipulation of endovascular devices. The exchange and manipulation of
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wires, sheaths, and stent devices is severely restricted when the distance from the plaque to the
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arterial puncture is short. Even routine exchanges risk loosening plaque for later embolization or
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inducing a dissection.
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To overcome these challenges, we modified the TCAR procedure by adding a prosthetic arterial
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conduit. This technique has a demonstrated record of safety in other endovascular procedures
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such as iliac artery prosthetic conduits for aortic endograft delivery, and requires no special
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training or devices. We believe that this provides a stable access route for CAS that would
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provide sufficient room to maneuver even in the setting of constrained neck anatomy.
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3. Surgical Approach
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General anesthesia was used for all procedures. The neck and chest on the appropriate side were
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prepped and draped and an arterial line was placed in the contralateral radial artery. An oblique
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incision was made in virgin territory at the base of the neck. Dissection was carried to the
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sternocleidomastoid, which was retracted laterally. The vagus nerve and internal jugular vein
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were identified and preserved. A 3-4 cm segment of the CCA was exposed (Figure 1A).
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Following systemic heparinization, the CCA is controlled with proximal and distal vessel loops
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and clamps and a longitudinal arteriotomy is performed. A 6-mm polytetrafluoroethylene (PTFE)
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conduit was anastomosed to the CCA in end to side fashion (Figure 1B). In cases with a steep
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angle at the clavicle, the proximal end of the graft was tunneled and brought out through a
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counter incision on the anterior chest wall. The free end of the conduit was secured with a
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Rummel tourniquet and, with the patient in Trendelenberg, the conduit was de-aired and flushed
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with heparin-saline. A 6 French sheath was advanced into the conduit to provide a stable
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platform for embolic protection device (EPD) and stent deployment (Figure 2). We established a
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roadmap with an antegrade angiogram (Figure 3A) and the EPD (Nav-6 filter, Abbott Vascular,
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Menlo Park, CA) was deployed under fluoroscopic guidance. An appropriately sized self-
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expanding stent (Exact, Abbott Vascular, Menlo Park, CA) was deployed across the lesion and
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completion angiography confirmed resolution of the lesion (Figure 3B). The EPD, wires, and
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sheaths were removed. The conduit was transected close to the surface of the CCA and sutured
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closed transversely to prevent narrowing, effectively creating a patch angioplasty. The platysma,
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subcutaneous tissue, and skin were closed and the patient was recovered from anesthesia. Duplex
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ultrasonography at outpatient follow up confirmed normal flow at the CCA and a well apposed
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stent in each case (Figure 4).
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4. Results
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All patients had high comorbidity burdens but tolerated their procedures well. Patient baseline
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characteristics are outlined in Table 1.
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Patient 1 was an 83-year-old male who was being followed after bilateral carotid
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endarterectomies. Critical restenosis (>90%) of the left CCA was found immediately inferior to
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the prior endarterectomy. Transfemoral CAS was attempted but significant tortuosity and a
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bovine arch precluded access. This patient underwent transcervical CAS via an arterial conduit
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as described above. Completion angiogram showed complete resolution of the lesion. A duplex
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ultrasound (DUS) 17 days after surgery showed no residual stenosis. The patient has been
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followed for 7 months without adverse events or recurrent stenosis on duplex.
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Patient 2 was a 64-year-old female who initially presented for a symptomatic type B aortic
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dissection, which was treated with thoracic endovascular aortic repair through a left common
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iliac conduit due to very small native external iliac arteries. During her initial stay, she was
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screened with duplex for associated carotid dissection and found to have stenosis of 80-99%. She
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underwent CEA but experienced restenosis on follow-up over the subsequent year. Computed
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tomographic angiography (CTA) demonstrated high-grade restenosis with string sign. Given the
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complexity of repeat iliac access and a heavy burden of plaque in the arch, we performed
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transcervical CAS with a conduit. At 3 months of follow up, duplex showed increased velocities
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distal to the stent representing <50% stenosis but no stenosis at the conduit site.
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Patient 3 is a 75-year-old female with a prior left CEA who presented with asymptomatic
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recurrent stenosis of 80-99% stenosis on magnetic resonance angiography as well as a type 3 and
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bovine aortic arch. She had thick scarring at her CEA site. Given the re-operative field and her
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complex arterial anatomy, she underwent a transcervical CAS with conduit. DUS 7 days
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postoperatively showed no significant stenosis. At 3 months follow up she continues to do well
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without recurrent stenosis on duplex.
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Patient 4 was a 73-year-old male with a prior right CEA 12 years ago. Interval CTA showed
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restenosis exceeding 90% as well as a complex ulcerated calcific lesion in the wall of the
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proximal right ICA that was concerning for a limited dissection. Transfemoral CAS was
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attempted but unsuccessful due to significant tortuosity of his bovine arch. Transcervical CAS
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with conduit was performed as described and completion angiogram showed complete resolution
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of the stenosis and coverage of the dissection. The patient tolerated the procedure well and was
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discharged after overnight monitoring. On follow up at 6 weeks, DUS showed no evidence of
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stenosis and he was free of adverse events.
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Overall, all patients in our small series did well following their procedure and did not experience
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major adverse outcomes, as outline in Table 2.
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5. Discussion
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The incidence of restenosis after CEA have been reported to be between 6% and 22%.8–10 A
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secondary analysis of Carotid Revascularization Endarterectomy vs Stenting Trial (CREST)
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reported a restenosis rate of 6.3% at 2 years and associated it with clinically significant increased
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risk of stroke when recurrent stenosis is >70%.11 For the management of such lesions, most
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studies show a higher rate of cranial nerve injuries and one recently published study from
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Vascular Quality Initiative data described higher mortality in high risk patients with redo CEA
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compared to CAS.12 CAS is a better alternative as CEA is also associated with increased
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incidence of cranial nerve injuries and wound complications.13,14
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Transcervical CAS has been reported as a safer alternative to transfemoral CAS in certain high
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risk populations.5 The transcervical approach allows surgeons to bypass difficult arch anatomy,
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improve the technical feasibility of CAS and may reduce the perioperative stroke rate. Our
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technique goes one step beyond direct puncture by eliminating of the requirement for several
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centimeters of sheath within the common carotid artery. The sheath may be positioned almost
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entirely within the conduit itself while still providing a stable platform with abundant room for
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maneuvering of wires and devices. By adding effective maneuver length, the surgeon is able to
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treatment of even proximal lesions in patients with short necks or with tortuous carotid anatomy,
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where it might otherwise be difficult to safely pass through the region of stenosis. The long
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sheaths used in this technique were seen as an advantage given the ability of the surgeon to use
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this access method without acquiring additional new or specialized equipment. The technique
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works just as well with shortened sheaths, wires, and devices.
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While the use of a prosthetic conduit does require some additional exposure relative to
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conventional TCAR and the anastomosis is an additional step, the added complexity at this stage
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simplifies the manipulation of wires and catheters later on. The overall complexity is thus similar
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to TCAR without a conduit or conventional CAS. As all wire and catheter exchanges can be
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conducted with a greater effective distance between the sheath and the target lesion, control of
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the wire and sheath passage is excellent. Additionally, since most repeated manipulations occur
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either within the native vessel or within the conduit, this method could potentially reduce the risk
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of dissecting the accessed vessel due to exchanges through the wall of the CCA.
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In our case series of 4 patients with post-CEA restenosis and with difficult aorto-iliac, aortic arch
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or CCA anatomy, we safely treated them all with transcervical CAS via a 6-mm PTFE conduit
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anastomosed to the proximal common carotid artery. This provided a stable access route for
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stenting and manipulation of endovascular devices while avoiding complicating anatomy and
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prior scar tissue.
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The surgical approach of this novel method is a broadly applicable procedure that could be used
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by any trained vascular surgeon. By the addition of the PTFE conduit, the operator is able to
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perform the procedure via a long, stable platform. This technique allows the operator to traverse
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the lesion reliably and potentially reduces the risk of embolization during transfemoral CCA
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access. Transcervical access can be challenging with short thick necks. For this reason, we have
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found our technique adapts well to this constrained anatomy. This approach reduces the
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difficulty of the operation without altering traditional CAS techniques.
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The short-term outcomes of our case series have been positive with no evidence of
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atheroembolic stroke, cervical hematomas, or cranial nerve injuries during the perioperative and
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post-operative period. All our patients were discharged within 36 hours of the procedure. Our
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follow up, the longest of which was 7 months, also showed no signs of CCA
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bleeding/pseudoaneurysm/stenosis and no mortalities. One patient, who had early re-stenosis
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following CEA had some evidence of mild in-stent or distal ICA re-stenosis. While additional
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follow-up and validation is required, we believe that this is a promising means of overcoming
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specific anatomic limitations that preclude transfemoral CAS.
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This technique expands the options for the vascular surgeon treating a patient with restenosis
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following endarterectomy with complex proximal anatomy. While the anatomic variations that
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necessitate a transcervical approach are uncommon, they are not rare and require innovative
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solutions. We offer this technique to selected patients who have contraindications to more
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conventional interventions for carotid disease, who can avoid complex repeat endarterectomy
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procedures. The longer-term effects of the conduit stump are unknown, although long-term
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studies of PTFE patch angioplasty have shown favorable outcomes compared to other patch
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materials.15,16 Larger numbers of patients will ultimately be required to validate the safety and
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effectiveness of this technique as well as to evaluate longer-term outcomes.
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6. Conclusions
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We introduce transcervical carotid stenting through a prosthetic conduit as an alternative to
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traditional transcervical and transfemoral CAS. It has broad applications, requires no additional
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equipment or training for any vascular surgeon, has minimal additional cost associated with the
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technique. This approach can be utilized in situations with aorto-iliac occlusive disease, difficult
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aortic arch anatomy, or in the presence of sever CCA tortuosity where a short or obese neck can
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preclude direct and reliable transcervical access to the CCA.
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Funding: This research did not receive any specific grant from funding agencies in the public,
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commercial, or not-for-profit sectors. BKL is supported by grants from NINDS-NIH, NIA-NIH,
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VA CSR&D, VA RR&D, and SVS.
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Conflicts of Interest: The authors have no conflicts of interest to disclose.
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References:
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1.
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Hobson RW, Lal BK, Chaktoura E, Goldstein J, Haser PB, Kubicka R, et al. Carotid artery stenting: Analysis of data for 105 patients at high risk. J Vasc Surg [Internet]. 2003
213
Jun;37(6):1234–9. Available from: http://dx.doi.org/10.1016/S0741-5214(02)75448-7
214
2.
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Yadav JS, Wholey MH, Kuntz RE, Fayad P, Katzen BT, Mishkel GJ, et al. Protected Carotid-Artery Stenting versus Endarterectomy in High-Risk Patients. N Engl J Med
216
[Internet]. 2004 Oct 7;351(15):1493–501. Available from:
217
http://dx.doi.org/10.1056/NEJMoa040127 3.
Wholey MH, Wu WCS. Current status in cervical carotid artery stent placement. J
221
AC C
218
EP
215
222
Oct;40(4):746–51; discussion 751. Available from:
223
http://dx.doi.org/10.1016/j.jvs.2004.07.021
Cardiovasc Surg (Torino). 2009 Feb;50(1):29–37.
219 220
224
4.
Choi HM, Hobson RW, Goldstein J, Chakhtoura E, Lal BK, Haser PB, et al. Technical challenges in a program of carotid artery stenting. J Vasc Surg [Internet]. 2004
5.
Sfyroeras GS, Moulakakis KG, Markatis F, Antonopoulos CN, Antoniou GA, Kakisis JD,
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et al. Results of carotid artery stenting with transcervical access. J Vasc Surg [Internet].
226
2013 Nov;58(5):1402–7. Available from: http://dx.doi.org/10.1016/j.jvs.2013.07.111
227
6.
Liu Z-J, Fu W-G, Guo Z-Y, Shen L-G, Shi Z-Y, Li J-H. Updated Systematic Review and Meta-Analysis of Randomized Clinical Trials Comparing Carotid Artery Stenting and
229
Carotid Endarterectomy in the Treatment of Carotid Stenosis. Ann Vasc Surg [Internet].
230
2012 May;26(4):576–90. Available from: http://dx.doi.org/10.1016/j.avsg.2011.09.009 7.
Brott TG, Hobson RW, Howard G, Roubin GS, Clark WM, Brooks W, et al. Stenting
SC
231
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versus Endarterectomy for Treatment of Carotid-Artery Stenosis. N Engl J Med [Internet].
233
2010 Jul;363(1):11–23. Available from: http://dx.doi.org/10.1056/NEJMoa0912321
234
8.
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Keagy BA, Edrington RD, Poole MA, Johnson G. Incidence of recurrent or residual
235
stenosis after carotid endarterectomy. Am J Surg [Internet]. 1985;149(6):722–5. Available
236
from: http://dx.doi.org/10.1016/S0002-9610(85)80173-2 9.
Goodney PP, Nolan BW, Eldrup-Jorgensen J, Likosky DS, Cronenwett JL. Restenosis
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after carotid endarterectomy in a multicenter regional registry. J Vasc Surg [Internet].
239
2010 Oct;52(4):897–904, 905-2-5. Available from:
240
http://dx.doi.org/10.1016/j.jvs.2010.05.005 10.
Surg [Internet]. 1997 Sep;84(9):1206–19. Available from:
242
http://dx.doi.org/10.1046/j.1365-2168.1997.02849.x
243 244 245
Lattimer CR, Burnand KG. Recurrent carotid stenosis after carotid endarterectomy. Br J
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238
11.
Lal BK, Beach KW, Roubin GS, Lutsep HL, Moore WS, Malas MB, et al. Restenosis after carotid artery stenting and endarterectomy: A secondary analysis of CREST, a
246
randomised controlled trial. Lancet Neurol [Internet]. 2012;11(9):755–63. Available from:
247
http://dx.doi.org/10.1016/S1474-4422(12)70159-X
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12.
Arhuidese I, Obeid T, Nejim B, Locham S, Hicks CW, Malas MB. Stenting versus
249
endarterectomy after prior ipsilateral carotid endarterectomy. J Vasc Surg [Internet]. 2017
250
Jan;65(1):1–11. Available from: http://dx.doi.org/10.1016/j.jvs.2016.07.115 13.
AbuRahma AF, Choueiri MA. Cranial and cervical nerve injuries after repeat carotid
RI PT
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endarterectomy. J Vasc Surg [Internet]. 2000 Oct;32(4):649–54. Available from:
253
http://dx.doi.org/10.1067/mva.2000.109751 14.
Marques de Marino P, Martinez Lopez I, Hernandez Mateo MM, Cernuda Artero I,
SC
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Cabrero Fernandez M, Reina Gutierrez MT, et al. Open Versus Endovascular Treatment
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for Patients with Post-Carotid Endarterectomy Restenosis: Early and Long-term Results.
257
Ann Vasc Surg [Internet]. 2016 Oct;36:159–65. Available from:
258
http://dx.doi.org/10.1016/j.avsg.2016.02.027
259
15.
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AbuRahma AF, Robinson PA, Saiedy S, Kahn JH, Boland JP. Prospective randomized trial of carotid endarterectomy with primary closure and patch angioplasty with saphenous
261
vein, jugular vein, and polytetrafluoroethylene: long-term follow-up. J Vasc Surg
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[Internet]. 1998 Feb [cited 2017 Mar 24];27(2):222-32-4. Available from:
263
http://www.ncbi.nlm.nih.gov/pubmed/9510277
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16.
Rerkasem K, Rothwell PM. Patches of different types for carotid patch angioplasty. In: Rothwell PM, editor. Cochrane Database of Systematic Reviews [Internet]. Chichester,
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UK: John Wiley & Sons, Ltd; 2010 [cited 2017 Mar 24]. Available from: http://doi.wiley.com/10.1002/14651858.CD000071.pub3
Figure Captions:
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Figure 1. Cervical common carotid access with A) isolation of CCA in virgin territory, B)
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anastomosis of PTFE conduit.
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Figure 2. Arrangement of conduit access with introducer sheath.
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Figure 3. Intraoperative angiography A) at start of case and B) post-stent.
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Figure 4. Postoperative duplex ultrasonography demonstrating laminar flow in the proximal
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common carotid around the site of the conduit anastomosis.
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Table 1: Patient demographics and baseline characteristics. Patient
Age Laterality Sex (y) & Stenosis
Restenosis Interval (y)
Comorbidities
83
M
Left 80-99%
12
HTN, Diabetes, ASA 3
2
65
F
Right 80-89%
0.8
HTN, Type B dissection s/p TEVAR, ASA 3
3
75
F
Left 71-99%
1.3
4
73
M
Right 80-99%
Prior bilateral CEA, bovine arch, failed transfemoral access Prior right CEA, arch atherosclerotic plaque burden, poor femoral anatomy, prior left iliac access
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Complicating factors
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HTN, Diabetes, Prior left CEA, bovine GERD, HLD, ASA arch 3 Tobacco use, HTN, Prior right CEA, bovine Prior AVR and arch, failed transfemoral access CABG, ASA 3
7
HTN, hypertension; ASA, American Society of Anesthesiology score; CEA, carotid endarterectomy; TEVAR, thoracic endovascular aortic repair; GERD, gastroesophageal reflux disease, HLD, hyperlipidemia; AVR, aortic valve replacement; and CABG, Coronary artery bypass graft.
20
7
2
24
3
3
36
4
25
CVA or TIA
Hematoma
Cranial Nerve Injury
Conduit Site Stenosis
None
None
None
Not detected
None
None
None
Not detected
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Table 2: Patient outcomes. LOS Follow up Patient (hours) (months)
None
None
None
Not detected
3
None
None
None
Not detected
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LOS, Length of stay; CVA, cerebrovascular accident; TIA, transient ischemic attack.
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