Faculty Bibliography

OBJECTIVE:The aim of this study was to evaluate the performance and predictors of failure of paclitaxel drug-eluting stents and paclitaxel coated balloons in the treatment of long-segment femoropopliteal disease. We report a retrospective cohort analysis of patients treated with paclitaxel eluting stents and paclitaxel coated balloons in lesions >100 mm, which were not included in any of the pivotal trials. METHODS:Ninety-seven patients with peripheral vascular disease (Rutherford III-VI) underwent long-segment (≥100 mm) femoropopliteal paclitaxel eluting stent (DES) implantation or angioplasty with paclitaxel coated balloons (DCB). Patients were followed after their initial procedure for target lesion restenosis, defined as a reduction in lumen diameter by greater than 50% as measured by duplex ultrasonography (ratio>2). RESULTS:The median length of the affected arterial segments was 110 mm (interquartile range [IQR] 100-150, absolute range 100-260) using up to 4 overlapping stents. During the median 13-month follow-up (IQR 7-16), no early thrombotic occlusions occurred within 30 days, but 28 (29%) patients developed a target lesion restenosis after 1 year. Cumulative primary patency at 6 and 12 months was 87% and 71% overall, respectively. The cumulative patency during the same follow-up periods, varied between patients treated with different paclitaxel modalities with 88% and 80% primary patency in patients treated with DES (n=63) versus 81% and 49% in patients treated with DCB (n=21) (adjusted hazard ratio 2.46, p=0.03). Lesion length, concurrent tibial intervention and recurrent target lesions were not associated with restenosis. CONCLUSION/CONCLUSIONS:Short-term outcomes in patients treated with paclitaxel eluting stents and paclitaxel coated balloons in long lesions, mirror results from the clinical trials. The primary patency observed in patients treated with DES was significantly higher than in patients treated with DCBs.

OBJECTIVE:Ischemic complications (including in the lower extremity, visceral, spinal, and pelvic territories) following standard endovascular aortic repair (EVAR) are well recognized but fortunately uncommon. The incidence of such complications following fenestrated and branched aortic repair (F/BEVAR) has not been well defined in the literature. The objective of this study was to compare the incidence of ischemic complications between EVAR and F/BEVAR and to elucidate potential risk factors for these complications. METHODS:We identified all patients who underwent EVAR from 2003 to 2017 or F/BEVAR from 2012 to 2017 in the national Vascular Quality Initiative database. We assessed differences in perioperative ischemic outcomes with methods including logistic regression and inverse probability of treatment propensity score weighting, using a composite endpoint of lower extremity ischemia, intestinal ischemia, stroke, or new dialysis as the primary endpoint. RESULTS:The data comprised 35,379 EVAR patients and 3374 F/BEVAR patients. F/BEVAR patients were more likely to be female, have had previous aneurysm repairs, and be deemed unfit for open aneurysm repair; they were less likely to have ruptured aneurysms; and they had higher estimated blood losses, contrast volumes, and fluoroscopy and procedure times. The incidence of any ischemic event (7.7% vs 2.2%) as well as the incidences of the component endpoints of lower extremity ischemia (2.3% vs 1.0%), intestinal ischemia (2.7% vs 0.7%), stroke (1.5% vs 0.3%), and new hemodialysis (3.1% vs 0.4%) were all significantly increased (all P < .001) in F/BEVAR compared with standard EVAR. After propensity adjustment, F/BEVAR conferred increased odds of any ischemic complication (1.8), intestinal ischemia (2.0), lower extremity ischemia (1.3), new hemodialysis (10.2), and stroke (2.3). CONCLUSIONS:Rates of lower extremity ischemia, intestinal ischemia, new dialysis, and stroke each range from 0% to 1% for standard EVAR and 1% to 3% for F/BEVAR. The incidence of perioperative ischemic complications following F/BEVAR is significantly increased compared to EVAR. The real-world data in this study should help guide decision-making for surgeons and patients as well as serve as one metric for progress in device and technique development. Improvements in ischemic complications may come from continued technology development such as smaller sheaths, improved imaging to decrease procedure time and contrast volume, embolic protection, and increased operator skill with wire and catheter manipulation.

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.