Clinical outcomes of transcarotid artery revascularization vs carotid endarterectomy from a large single-center experience.

BACKGROUND: Transcarotid artery revascularization (TCAR) has been practiced as an alternative for both carotid endarterectomy (CEA) and transfemoral carotid artery stenting, specifically in high-risk patients. More recently, the Centers for Medicare and Medicaid Services expanded coverage for TCAR in standard surgical risk patients if done within the Society for Vascular Surgery Vascular Quality Initiative TCAR surveillance project. A few registry studies (primarily from the Society for Vascular Surgery Vascular Quality Initiative) compared the early and up to 1-year outcomes of TCAR vs CEA or transfemoral carotid artery stenting. There is no large single-center study that reported late clinical outcomes. The present study compares intermediate clinical outcomes of TCAR vs CEA. METHODS: This study retrospectively analyzed collected data from TCAR surveillance project patients enrolled in our institution and compare it with CEA patients done by the same providers at the same time period. The primary outcome was combined perioperative stroke/death and late stroke/death. Secondary outcomes included combined stroke, death, and myocardial infarction, cranial nerve injury (CNI), and bleeding. Propensity matching was done to analyze outcome. Kaplan-Meier analysis was used to estimate freedom from stroke, stroke/death, and ≥50% and ≥80% restenosis. RESULTS: We analyzed 646 procedures (637 patients) (404 CEA, 242 TCAR). There was no significant difference in the indications for carotid intervention. However, TCAR patients had more high-risk criteria, including hypertension, coronary artery disease, congestive heart failure, and renal failure. There was no significant differences between CEA vs TCAR in 30-day perioperative stroke (1% vs 2%), stroke/death rate (1% vs 3%; P = .0849), or major hematomas (2% vs 2%). The rate of CNI was significantly different (5% for CEA vs 1% for TCAR; P = .0138). At late follow-up (2 years), the rate of stroke was 1% vs 4% (P = .0273), stroke/death 8% vs 15% (P = .008), ≥80 % restenosis 0.5% vs 3% (P = .0139) for CEA patients vs TCAR patients, respectively. After matching 242 CEAs and 242 TCARs, the perioperative stroke rate was 1% for CEA vs 2% for TCAR (P = .5037), the stroke/death rate was 2% vs 3% (P = .2423), and the CNI rate was 3% vs 1% (P = .127). At late follow-up, rates of stroke were 1% for CEA vs 4% for TCAR (P = .0615) and stroke/death were 8% vs 15% (P = .0345). The rate of ≥80% restenosis was 0.9% for CEA vs 3% for TCAR (P = .099). The rates of freedom from stroke at 6, 12, 18, and 24 months for CEA vs TCAR were 99%, 99%, 99%, and 99% vs 97%, 95%, 93% and 93%, respectively (P = .0806); stroke/death were 94%, 90%, 87%, and 86% vs 93%, 87%, 76%, and 75%, respectively (P = .0529); and ≥80% restenosis were 100%, 99%, 98%, and 98% vs 97%, 95%, 93%, and 93%, respectively (P = .1132). CONCLUSIONS: In a propensity-matched analysis, both CEA and TCAR have similar perioperative clinical outcomes. However, CEA was superior to TCAR for the rates of late stroke/death and had a somewhat lower rate of ≥80% restenosis at 2 years, but this difference was not statistically significant.

Long-term durability and clinical outcome of a prospective randomized trial comparing carotid endarterectomy with ACUSEAL polytetrafluoroethylene patching versus pericardial patching.

BACKGROUND: Several studies have shown the superiority of carotid endarterectomy (CEA) with patch closure over primary closure. However, no definite study has shown any significant differences in clinical outcome between various types of patches. Because more vascular surgeons have used pericardial patching recently, this study will analyze the late clinical outcome (≥10 years) of our previously reported prospective randomized trial comparing CEA with ACUSEAL (polytetrafluoroethylene) vs pericardial patching. METHODS: A total of 200 CEAs were randomized (1:1) to either Vascu-Guard pericardial patching or ACUSEAL patching. All patients had immediate duplex ultrasound imaging, which was repeated at 6 months and annually thereafter. Kaplan-Meier analysis was used to estimate rates of freedom from stroke, stroke-free survival, and rates of freedom from ≥50% and ≥80% restenosis. RESULTS: Overall demographic and clinical characteristics were somewhat similar with a mean follow-up of 80 months (range: 0-149 months). The rates of freedom from stroke were 97, 97, 97, 96, 93 for ACUSEAL vs 99, 98, 97, 97, 92 for pericardial patching (P = .1112) at 1, 2, 3, 5, and 10 years, respectively. Similarly, the rates of freedom from stroke/death were 94, 93, 90, 76, 50 for ACUSEAL vs 99, 96, 91, 78, 47 for pericardial patching (P = .8591). The rates of freedom from ≥50% restenosis were 98, 98, 96, 89, 79 for ACUSEAL vs 87, 83, 83, 81, 71 for pericardial patching (P = .0489). The rates of freedom from ≥80% restenosis were 99, 99, 99, 96, 85 for ACUSEAL vs 96, 96, 96, 93, 93 for pericardial patching (P = .9407). The overall survival rates were 95, 94, 91, 77, 51 for ACUSEAL vs 100, 98, 93, 79, 50 for pericardial patching (P = .9123). Other patch complications (eg, rupture, aneurysmal dilation, infection, etc) were similar. CONCLUSIONS: Both CEA with ACUSEAL (polytetrafluoroethylene) and pericardial patching are durable and have similar clinical outcomes at 10 years except that ACUSEAL patching has significantly better rates of freedom from ≥50% restenosis.

A single-center experience of 30-day perioperative and one year clinical outcomes of transcarotid artery revascularization in 100 consecutive patients.

BACKGROUND: Transcarotid Artery Revascularization (TCAR) using the ENROUTE system (Silk Road) has been proposed as a safe and effective alternative to both carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TF-CAS). Two large registries (ROADSTER 1 and ROADSTER 2) have shown that TCAR has acceptable/low rates of perioperative stroke/death. This study will analyze the 30-day perioperative and 1-year clinical outcomes from a single-center. PATIENT POPULATION AND METHODS: This is a retrospective analysis of prospectively collected data from SVS/VQI TCAR surveillance project (TSP) of 100 consecutive patients (102 TCAR procedures) done in our institution. These procedures were done for high-risk patients for CEA, which included anatomical (previous CEA, high cervical lesion, neck radiation, stoma, arch type, etc.), physiological (CHF, severe coronary artery disease, COPD on O2 therapy, etc.) and combined anatomical/physiological reasons. These procedures were done by vascular surgeons after receiving the appropriate training. The perioperative stroke, death, and MI rates were analyzed. Kaplan Meyer analysis was used to estimate rate of freedom from stroke/death and the incidence of ≥50% and ≥80% in-stent restenosis at 1 year. RESULTS: 100 consecutive high-risk patients for CEA included: 38% anatomical, 44% physiological, and 18% combined anatomical and physiological reasons. The mean age was 72.5 years (range 52-90 years). Indications for TCAR were 34% for symptomatic lesions (TIA/stroke) and 66% for asymptomatic lesions. Mean ipsilateral treated stenosis was 80.4%. Contralateral ≥50% stenosis/occlusion was present in 31% of patients. Technical success rate was 100%. 92% had pre-stenting PTA and 26% had post-stenting PTA. The mean flow reversal time was 8.5 min (range 3-26 min). The 30-day perioperative stroke rate was 2.9% (1/67, 1.5% for asymptomatic patients), the stroke/death rate was 2.9%, and stroke/death and MI rate was 3.9% (4/102). Other perioperative complications included cranial nerve injury 3/102 (2.9%), carotid artery dissection (2%), and major hematoma (necessitated operation evacuation) (5.9%). Freedom from stroke rates and stroke/death rates at 1 year were: 90% and 89%. Freedom from ≥50% and ≥80% in-stent restenosis rates at 1 year were 82% and 90%, respectively. None of these restenosis were symptomatic except two (2/13). Freedom from reintervention rate at 1 year was 98%. CONCLUSION: Although the perioperative events were somewhat higher than what has been reported in previous registries, TCAR for patients who are high-risk for CEA has a low perioperative stroke and stroke/death rates with satisfactory outcome at 1 year. Further long-term data is probably needed to verify long-term outcome.

Rates of progression of carotid in-stent stenosis and clinical outcomes.

BACKGROUND: We previously reported the incidence of ≥50% and ≥80% carotid in-stent stenosis. In the present study, we analyzed the rate of progression of in-stent stenosis and clinical outcomes with longer follow-up. METHODS: We performed a retrospective analysis of prospectively collected data for 450 patients who had undergone transfemoral carotid artery stenting with longer follow-up (mean, 70 months). The progression of in-stent stenosis was defined as stenosis advancing to a higher severity of disease (ie, from <50% to ≥50% and from ≥50% to ≥80%). Kaplan-Meier analysis was used to estimate the rate of progression from <50% to ≥50% and ≥50% to ≥80%, the overall rates of ≥50% and ≥80% in-stent stenosis, and survival at 1, 3, 5, and 10 years. RESULTS: At a mean follow-up of 70.3 months (range, 1-222 months), 121 of 446 patients (27%) had had progression to ≥50% and 39 (8.7%) to ≥80% in-stent stenosis. Of the 406 patients whose first duplex ultrasound findings were normal or showed in-stent stenosis of <50%, 82 had had progression from normal or <50% to ≥50% in-stent stenosis at a mean of 51.7 months (range, 1-213 months). Of the 121 patients with ≥50% stenosis, 14 (11.6%) had experienced progression to ≥80% at a mean of 33.6 months (range, 6-89 months). Of the 82 patients with progression from <50 to ≥50%, 10 (12%) had experienced a neurologic event (eight transient ischemic attacks [TIAs] and two strokes). Of the 14 with progression from ≥50% to ≥80%, 2 (14.3%) had experienced a TIA, and the remaining patients were asymptomatic. Of the 39 patients with ≥80% in-stent stenosis, 9 (23%) had experienced a neurologic event (eight TIAs and one contralateral stroke). Overall, 13 of the 121 patients with late ≥50% restenosis (10.7%) had experienced a neurologic event (10 ipsilateral TIA, 2 ipsilateral stroke, and 1 contralateral stroke. Thus, 12 of 446 patients (2.7%) had experienced an ipsilateral TIA or stroke at a mean follow-up of 70 months. The rates of freedom from <50% to ≥50% in-stent stenosis progression were 93%, 85%, 78%, and 66% at 1, 3, 5, and 10 years. The rates of freedom from progression from ≥50% to ≥80% in-stent stenosis were 89%, 81%, and 77% at 1, 3, and 5 years, respectively. The overall rates of freedom from ≥50% in-stent stenosis and ≥80% in-stent stenosis were 86%, 77%, 71%, and 59% and 96%, 93%, 91%, and 84% at 1, 3, 5, and 10 years, respectively. Finally, the stroke survival rates were 95%, 80%, 63%, and 31% at 1, 3, 5, and 10 years, respectively. CONCLUSIONS: The rate of progression of carotid in-stent stenosis was modest, with a low incidence of stroke events. Therefore, the use of duplex ultrasound surveillance after carotid artery stenting should be selective and its benefits and utility perhaps reevaluated.

Azygos Vein Central Venous Access in a Patient with Thoracic Central Venous Obstruction.

This is a report of a 45-year-old female with thoracic central venous obstruction (TCVO) and alpha-1 antitrypsin deficiency requiring an implanted port for infusions. The azygos vein was used for catheter access in the setting of an occluded right internal jugular vein, bilateral innominate, and superior vena cava. A literature review examines the etiology of TCVO and superior vena cava syndrome (SVC), as well as the potential benefits and complications for using the azygos vein in patients with TCVO requiring port or catheter venous access.

Anatomically Coiled Internal Carotid Artery Resulting in Severe Dysphagia and Burning Mouth Syndrome.

This is a report of a 65-year-old female presenting with symptoms of dysphagia due to a coiled left internal carotid artery, treated with resection and primary repair. Dysphagia lusoria is more commonly caused by aortic arch anomalies, aberrant subclavian or common carotid arteries. Internal carotid tortuosity as a cause of severe dysphagia and burning mouth syndrome is highly unusual. A literature review examines the etiology, natural history, and treatment options.

Bilateral extracranial internal carotid artery aneurysms: Case report and review of literature.

This is a report of a 62-year-old male with bilateral extracranial internal carotid artery aneurysms, treated with resection, and interposition bypass. Bilateral presentation of carotid aneurysms is an uncommon finding in an already rare disease. We review the etiology, natural history, and treatment options.

Thirty-Day Perioperative Clinical Outcomes of Transcarotid Artery Revascularization vs Carotid Endarterectomy in a Single-Center Experience.

BACKGROUND: Transcarotid artery revascularization (TCAR) has been proposed as a alternative to carotid endarterectomy (CEA) and transfemoral carotid artery stenting in high-risk patients. Recently Centers for Medicare and Medicaid Services expanded coverage for TCAR to include standard surgical risk patients within the Society of Vascular Surgery Vascular Quality Initiative TCAR Surveillance Project. Few single centers compared the clinical outcome of TCAR with CEA. This study compares 30-day perioperative clinical outcomes between TCAR and CEA. STUDY DESIGN: This is retrospective analysis of prospectively collected data from the TCAR Surveillance Project of TCAR patients enrolled in our institution and compared with CEAs done in the same time/with the same providers. The primary outcome was stroke and/or death. Secondary outcomes included stroke, death, MI, cranial nerve injury, bleeding, and others. Propensity matching was done to analyze outcomes. RESULTS: The study analyzed 501 patients (347 CEA, 154 TCAR). There were no significant differences in symptomatic status (43% for CEA vs 38% for TCAR, p = 0.303). TCAR had more patients with hypertension (p = 0.04), coronary artery disease (p = 0.028), and congestive heart failure (p = 0.039). The 30-day perioperative complication rates for CEA vs TCAR were as follows: stroke 1% vs 3% (p = 0.142), stroke/death 1% vs 3% (p = 0.185), MI 0.6% vs 0.7% (p = 1), death 0.6% vs 0% (p = 1), stroke/death/MI 2% vs 4% (p = 0.233), cranial nerve injury 4% vs 2% (p = 0.412), and major hematoma (requiring reintervention) 2% vs 3% (p = 1). After matching 154 CEA patients and 154 TCAR, 30-day perioperative complication rates were as follows: stroke 2% vs 3% (p = 0.723), stroke/death 3% vs 3% (p = 1), death 1.3% vs 0% (p = 0.498), MI 0.7% vs 0.7% (p = 1), and stroke/death/MI 3% vs 4% (p = 0.759). CONCLUSIONS: This study showed that using propensity match analysis, both CEA and TCAR have similar 30-day perioperative outcomes. Further long-term data are needed.

A Novel Strategy for Attenuating Opioid Withdrawal in Neonates.

The rate of Neonatal Abstinence Syndrome (NAS) has drastically increased over the past decade. The average hospital expense per NAS patient has tripled, while the number of babies born to opioid-dependent mothers has increased to 5 in 1000 births. Current treatment options are limited to opioid replacement and tapering. Consequently, we examined the efficacy of prenatal, low-dose and short-term vigabatrin (γ-vinyl GABA, GVG) exposure for attenuating these symptoms as well as the metabolic changes observed in the brains of these animals upon reaching adolescence. Pregnant Sprague-Dawley rats were treated in one of four ways: 1) saline; 2) morphine alone; 3) morphine+GVG at 25 mg/kg; 4) morphine+GVG at 50 mg/kg. Morphine was administered throughout gestation, while GVG administration occurred only during the last 5 days of gestation. On post-natal day 1, naloxone-induced withdrawal behaviours were recorded in order to obtain a gross behaviour score. Approximately 28 days following birth, 18FDG microPET scans were obtained on these same animals (Groups 1, 2, and 4). Morphine-treated neonates demonstrated significantly higher withdrawal scores than saline controls. However, GVG at 50 but not 25 mg/kg/day significantly attenuated them. Upon reaching adolescence, morphine treated animals showed regionally specific changes in 18FDG uptake. Again, prenatal GVG exposure blocked them. These data demonstrate that low-dose, short-term prenatal GVG administration blocks naloxone-induced withdrawal in neonates. Taken together, these preliminary findings suggest that GVG may provide an alternative and long-lasting pharmacologic approach for the management of neonatal and adolescent symptoms associated with NAS.