Faculty Bibliography

Objective: In patients deemed high risk for carotid endarterectomy (CEA) who are indicated for treatment of carotid artery stenosis (CAS), transcarotid artery revascularization (TCAR) has been demonstrated to be a safe and effective alternative to transfemoral CAS. Compared with CEA, in which approximately 12% of patients undergoing awake intervention do not tolerate internal carotid artery clamping, only 1% to 2% of patients were observed to have intolerance to flow reversal during TCAR based on data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) 1 and 2 trials. This study reviewed awake interventions from those trials to assess factors associated with intolerance to flow reversal and to review how those cases were managed.
Method(s): This is a retrospective review of prospectively collected data from the ROADSTER multicenter trial along with the subsequent postapproval (ROADSTER 2) trial. The subset of patients from both trials undergoing awake TCAR was analyzed to compare demographics, procedural details, and anatomic factors between patients who did and did not experience intolerance to reversal of flow to assess for predisposing factors. Patients were deemed intolerant to flow reversal at the discretion of the operator, often related to changes in completion of neurologic tasks, hemodynamic stability, or patient-reported symptoms.
Result(s): There were 103 patients from ROADSTER and 194 patients from ROADSTER 2 who underwent TCAR under local/regional anesthesia. Of these, eight patients had intolerance to flow reversal, although all cases were successfully completed. Four cases were completed under low-flow reversal, three cases were successfully weaned from low to high flow during several minutes, and one case required general anesthesia. No significant association was found between intolerance to flow reversal and comorbidities including diabetes mellitus, hypertension, hyperlipidemia, congestive heart failure, prior myocardial infarction or angina, preoperative CAS-related symptoms, prior stroke, prior CAS or CEA, prior neck irradiation, tandem stenosis, high cervical stenosis, or hostile neck (Tables I and II). A trend toward significance was seen with chronic obstructive pulmonary disease (P =.086) and contralateral carotid artery occlusion (P =.139).
Conclusion(s): Despite intolerance to flow reversal, most cases were successfully completed by adjusting reversal of flow rate and did not require conversion to general endotracheal anesthesia. Whereas factors contributing to intolerance of flow reversal during TCAR remain poorly understood, this study identified a trend toward significance with an association of pre-existing chronic obstructive pulmonary disease and contralateral carotid artery occlusion. Given the low number of patients who experienced this issue, a larger sample size is required to better elucidate these trends. [Formula presented] [Formula presented]
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OBJECTIVES/OBJECTIVE:While the use of protamine sulfate as a heparin reversal agent has been extensively reviewed in patients undergoing carotid endarterectomy and coronary artery bypass grafting, there is a lack of literature on protamine's effects on lower extremity bypasses. The purpose of this study was to determine the risk of protamine sulfate dosing after tibial bypass on thrombotic or bleeding events, including early bypass failure. METHODS:We performed a retrospective review of our institutional database for patients undergoing primary distal peripheral bypass from January 2009 through December 2015 (contralateral bypass was considered to be a new primary bypass). Primary endpoints include composite thrombotic events (myocardial infarction, stroke, amputation at 30 days and patency less than 30 days) and composite bleeding events (bleeding or transfusion). RESULTS: = 0.52). CONCLUSIONS:Heparin reversal with protamine sulfate after tibial or peroneal bypass grafting is not associated with higher cardiovascular morbidity, bypass thrombosis, amputation, or mortality. Additionally, there was no statistically significant difference in post-operative bleeding or thrombosis complications for patients who did not receive protamine, although the findings are suggestive of a potential difference in a more adequately powered study. Our results suggest that protamine sulfate is safe for intraoperative use without increased risk of thrombotic complications or early tibial bypass graft failure.

OBJECTIVE:The aim of this study was to evaluate the performance of paclitaxel-eluting stents (PES) and paclitaxel-coated balloons (PCB) on amputation free survival in patients with critical limb ischemia (CLI). METHODS:A retrospective review of all patients with Rutherford stage 5 and 6 limb ischemia undergoing endovascular revascularization with paclitaxel related technology, both PES and PCB was carried out over a 4-year period. Clinical grading was determined by Rutherford classification, and the Society for Vascular Surgery's Wound, Ischemia and Foot Infection (WIFi) scoring system. Clinical and angiographic follow-up was reviewed based on intention-to-treat analysis. The primary endpoint of this study was amputation free survival at 12 months. Secondary endpoints included wound healing, freedom from target lesion revascularization and patency of target vessels at 12 months. Follow up occurred at 3, 6 and 12 months post-operatively. Target lesion patency was defined as <50% stenosis, based on a duplex velocity ratio of less than or equal to 2. Post-operative ABI and duplex ultrasound were performed to verify successful treatment. Outcomes were evaluated using Kaplan-Meier and Cox Proportional Hazards models. RESULTS:A total of 88 limbs were revascularized in 88 patients. DES was used as the sole drug technology in 56 patients (60.7% male, median age 70.5 years), DCB was used as the sole drug technology in 32 patients (46.9% male, median age 66 years). Baseline demographics were well matched except for a higher prevalence of occluded target lesions in the DES group (41.1% vs. 12.5%; p=0.004). Limbs were treated for Rutherford stage 5 CLI in 71.6% and stage 6 CLI in 28.4%. Univariate analysis identified no dependent factors affecting limb salvage, except for the use of drug coated balloons. After 12 months of follow up, amputation free survival was significantly higher in the DES group compared to the DCB (88.5% vs. 71.1%; p=0.0443). Wound healing rates after 1 year were also higher in the DES group (83.9% vs. 59.4%; p=0.0198). Freedom from target lesion revascularization was no different between patients treated with DES compared to patients treated with DCB (90.6% vs. 85.7%; p=0.518. Primary patency at 12 months in patients treated with DES was significantly higher than patients treated with PCB (80.4% vs. 58.1%; p=0.0255). CONCLUSIONS:Overall, drug technology represents a viable option for patients with CLI; a cohort not represented in major randomized trials. In our experience, femoropopliteal lesions treated with DES have higher primary patency rates than those treated with DCB. This was found to support higher amputation free survival rates in patients treated with paclitaxel DES compared to paclitaxel DCB. The use of paclitaxel DES for CLI was also associated with significantly improved wound healing compared to DCB. Our data suggests improved outcomes with DES compared to DCB, however, these patients represent a non-randomized, heterogenous group that were treated with the operator's best judgement.

Innominate artery pathology is traditionally treated with open surgical repair and is associated with significant morbidity. No dedicated endovascular solution exists for this anatomic location. We report a series of 3 cases of successful management of innominate artery injuries using an off-label, modified Zenith ESLE stent graft (Cook Medical, Bloomington, IN). Two patients presented with pseudoaneurysms after attempted central venous catheterization, and 1 patient developed a tracheo-innominate fistula. Access was obtained in a retrograde fashion via the right common carotid artery in 2 cases, and via the right axillary artery in the other. Additional anatomic considerations included a prior sternotomy in 2 cases and a bovine arch in 2 cases. Due to the emergent nature of the cases, no cerebral protection maneuvers were taken. The ESLE limbs are of uniform diameter with 3 Z-stent wireforms and measure 55 mm in length. Removal of the distal stent reduces the length to 38 mm. Fourteen- to 18-mm diameter grafts were used. All 3 cases resulted in technical success with complete exclusion of the defect. There were no new neurologic deficits and all patients recovered uneventfully. This approach represents an effective off-label solution for what frequently presents as an emergent problem. In 2 cases, it obviated the need for a complicated redo sternotomy and facilitated endovascular repair in a vessel for which there was no indicated off-the-shelf conduit. Modification of existing devices successfully addressed the need for a nontapered graft of short length and moderate vessel diameter and allowed for minimally invasive treatment of anatomically complex pathology.

The link between coagulatory dysfunction in acute leukemias is well known, with patients having an increased risk of bleeding as well as thrombosis. Arterial thrombosis is particularly rare in this population however with only a few reported cases in the literature. We report the case of acute arterial occlusion secondary to a leukoblastic embolus causing limb-threatening ischemia in a patient with acute myelogenous leukemia. The patient was successfully treated surgically by open superficial femoral artery thrombectomy, common femoral endarterectomy with patch angioplasty, and percutaneous tibial embolectomy.