Early Outcomes in the ROADSTER 2 Study of Transcarotid Artery Revascularization in Patients With Significant Carotid Artery Disease.

BACKGROUND AND PURPOSE: Transcarotid artery revascularization (TCAR) is comprised of carotid artery stent placement with cerebral protection via proximal carotid artery clamping and reversal of cerebral arterial flow. The aim of the present study was to evaluate the safety and efficacy of TCAR performed by a broad group of physicians with variable TCAR experience. METHODS: The ROADSTER 2 study is a prospective, open label, single arm, multicenter, postapproval registry for patients undergoing TCAR. Patients considered at high risk for complications from carotid endarterectomy with symptomatic stenosis ≥50% or asymptomatic stenosis ≥80% were included. The primary end point was procedural success, which encompassed technical success plus the absence of stroke, myocardial infarction, or death within the 30-day postoperative period. Secondary end points included technical success and individual/composite rates of stroke, death, and myocardial infarction (MI). All patients underwent independent neurological assessments before the procedure, within 24 hours, and at 30 days after TCAR. An independent clinical events committee adjudicated all major adverse events. RESULTS: Between 2015 and 2019, 692 patients (Intent to Treat Population) were enrolled at 43 sites. Sixty cases had major protocol violations, leaving 632 patients adhering to the Food and Drug Administration-approved protocol (per-protocol population). The majority (81.2%) of operators were TCAR naïve before study initiation. Patients underwent TCAR for neurological symptoms in 26% of cases, and all patients had high-risk factors for carotid endarterectomy (anatomic-related 44%; physiological 32%; both 24%). Technical success occurred in 99.7% of all cases. The primary end point of procedural success rate in the Intent to Treat population was 96.5% (per-protocol 97.9%). The early postoperative outcomes in the Intent to Treat population included stroke in 13 patients (1.9%), death in 3 patients (0.4%), and MI in 6 patients (0.9%). The composite 30-day stroke/death rate was 2.3%, and stroke/death/MI rate was 3.2%. In the per-protocol population, there were strokes in 4 patients (0.6%), death in one patient (0.2%), and MI in 6 patients (0.9%) leading to a composite 30-day stroke/death rate of 0.8% and stroke/death/MI rate of 1.7%. CONCLUSIONS: TCAR results in excellent early outcomes with high technical success combined with low rates of postprocedure stroke and death. These results were achieved by a majority of operators new to this technology at the start of the trial. Adherence to the study protocol and peri-procedural antiplatelet therapy optimizes outcomes. Longer-term follow-up data are needed to confirm these early outcomes. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02536378.

An unusual cause of spinal cord ischemia after thoracic endovascular repair.

A 59-year-old left-handed man presented with chest pain and hypertension and was found to have an acute descending aortic dissection on imaging. After thoracic endovascular repair of the dissection, he developed left arm weakness and ischemia. Despite carotid-subclavian transposition, the patient was found to have persistent left triceps weakness as well as bilateral leg paresis. An urgent spinal drain was placed that improved his lower extremity deficit but did not greatly change his arm symptoms. Magnetic resonance imaging of the spine revealed previously undiagnosed severe multilevel spinal stenosis requiring operative decompression. To our knowledge, this is the first report of the contribution of cervical spinal stenosis to post-thoracic endovascular repair spinal ischemia.

Carotid Endarterectomy in the Face of a Persistent Hypoglossal Artery.

A 68-year-old woman presented with signs and symptoms suggestive of a cerebrovascular accident. Her work-up revealed left internal carotid artery stenosis consistent with her presentation of a left middle cerebral artery distribution stroke. Imaging also incidentally revealed a persistent hypoglossal artery. She underwent carotid endarterectomy. Our intraoperative strategy for management of this persistent fetal anomaly is reviewed.

Safety and efficacy of reteplase for the treatment of acute arterial occlusion: complexity of underlying lesion predicts outcome.

We evaluated both the safety and efficacy of reteplase for treatment of acute arterial occlusion as well as outcomes based on treatment of the underlying lesion. From November 2000 to February 2004, reteplase was used to treat arterial occlusions in 81 patients. Catheter-directed intrathrombus thrombolysis was performed with reteplase (0.5 units/hr) continuous infusion. Percutaneous mechanical thrombectomy (Angiojet) was performed in 61% (n = 50) of patients prior to thrombolysis. Unmasking of significant lesions resulted in endovascular intervention (39.5%), open surgical repair (24.6%), or both endovascular and surgical repair (9.8%) of the lesion. No lesion was found in 25.9% of patients. Major and minor complication rates as well as restoration of patency, limb salvage, and amputation-free survival were evaluated. Eighty-one patients received reteplase therapy (median = 10.3 +/- 5.3 units, 19.5 +/- 7.4 hr) followed by next-day arteriogram to assess thrombus removal. Technical success was achieved in 96.2% (n = 78) of cases. Kaplan-Meier life table analysis revealed overall primary patency rates of 76.3%, 60.1%, and 51.6%, at 1, 6, and 12 months, respectively. Overall amputation-free survival rates were 86.4%, 76.4%, and 69.7% at 1, 6, and 12 months, respectively. When subdivided into postlysis intervention, the lysis-only group achieved increased patency (p = 0.0143) and increased limb salvage (p = 0.0219) at 1 year compared to the lysis and endovascular intervention and the lysis and surgical groups. The 30-day complication rate was 17.3% (n = 14), with a major complication rate of 4.9% (n = 4) and a minor complication rate of 12.3% (n = 10). There were no intracranial hemorrhagic complications. Intra-arterial catheter-directed infusion of reteplase for acute lower extremity ischemia is safe and efficacious, as shown by the low risk of bleeding complications, high limb salvage rates, and low mortality rates in this study. The complexity of the lesion that is unmasked through thrombolytic therapy is a predictor of patency and limb salvage.

Does a standardization tool to direct invasive therapy for symptomatic lower extremity peripheral arterial disease improve outcomes?

OBJECTIVES: While decision analysis and treatment algorithms have repeatedly been shown to improve quality of care in many areas of medicine, no such algorithm has emerged for the invasive management of lower extremity peripheral arterial disease. Using the best available evidence-based outcomes data, our group designed a standardization tool, the Lower Extremity Grading System (LEGS) score, which consistently directs limbs to a specific treatment on the basis of presentation. The purpose of this study was to examine whether use of such a tool improves outcomes by directing treatment of lower extremity peripheral arterial disease. METHODS: Over 18 months (July 2001-December 2002) our group intervened in 673 limbs (angioplasty, open surgery, primary limb amputation) with lower extremity peripheral arterial disease. During this time we developed the LEGS score, and implemented its prospective use for the final 362 limbs. For the purpose of this study, all 673 limbs were retrospectively scored with the LEGS score to determine the LEGS recommended best treatment. Of the 673 limbs, 551 (81.9%) received the same treatment as recommended with LEGS and 122 (18.1%) received treatment contrary to LEGS. Limbs treated contrary to LEGS (cases) were then compared with matched control limbs (treated according to LEGS), with similar angiographic findings, clinical presentation, preoperative functional status, comorbid conditions and operative technical factors. Outcomes measured at 6 months included arterial reconstruction patency, limb salvage, survival, and maintenance of ambulatory status and independent living status. Kaplan-Meier curves were used to assess patency, limb salvage, and survival; associated survival curves were compared with the log-rank test. Functional outcomes were compared with the Fisher exact test. RESULTS: After matching case limbs with control limbs, 9 limbs had no control match. Thus 113 limbs in 100 patients treated contrary to LEGS were compared with 113 limbs in 100 patients treated according to LEGS. Limbs treated contrary to LEGS resulted in significantly inferior outcomes at 6 months for measures of primary patency (57.5% vs 84.3%; P < .001), secondary patency (73.2% vs 96.2%; P < .001), limb salvage (89.7% vs 97.2%; P = .04), and maintenance of ambulatory status (78% vs 92%; P = .02). As an additional finding, 29.6% (92 of 311) of interventions performed before implementation of the algorithm were treated contrary to LEGS, and thus contrary to objectively determined best therapy, compared with 8.3% (30 of 362) after LEGS implementation (P < .001). CONCLUSIONS: Limbs treated according to our standardization tool resulted in better outcomes compared with limbs treated contrary to the algorithm. These data suggest that routine use of an appropriately validated treatment standardization algorithm is capable of improving overall results for invasive treatment of lower extremity peripheral arterial disease.