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.

Diagnosis and treatment of a symptomatic primary thoracic aortic tumor: endovascular exclusion to prevent recurrent embolization.

Intraluminal aortic malignant masses are extremely rare. Clinical symptoms of these tumors include locally occlusive aortic disease, peripheral emboli, or mesenteric emboli. Eventually, general symptoms, such as fatigue, weight loss, or fever, will occur. Nevertheless, the diagnosis is most often made after surgery or autopsy, when histologic data can be examined. Few cases of intraaortic masses treated endovascularly have been reported, most of them related to intraluminal blood clot formation. We present a case of intraaortic malignant tumor formation with distal embolization to the legs, in which the diagnosis of malignant disease was reached after analysis of the material obtained during embolectomy. Endovascular exclusion was performed as a transient treatment to avoid new embolic events.

Renal embolization and nephrectomy in a single surgical act in high-risk renal tumor pathology.

BACKGROUND: Renal artery embolization is a procedure that has been shown to be useful as a concomitant treatment for the resection of large renal tumors. Over the years, preoperative renal artery embolization concomitant with nephrectomy as a treatment option has proved to be useful in reducing morbi-mortality rates; however this procedure is not exempt from significant iatrogenia. Performing this technique in conjunction with nephrectomy in a single surgical act helps to maintain the advantages of this treatment, which in turn considerably reduces the associated morbi-mortality rates. METHODS: This study presents seven patients selected by the Urology Service in a nonconsecutive manner who underwent renal artery embolization concomitant with nephrectomy in a single surgical procedure for large renal tumors, thus presenting a variation to the usual techniques to improve and simplify the procedure. RESULTS: General data were obtained from all patients including age, gender, characteristics of the tumor, and symptomatology at the time of diagnosis. For all the cases, use of resources was analyzed in terms of duration of surgery, the amount of iodinated contrast medium used during the embolization procedure, and the mean duration of hospital and intensive care unit stay. Complications were evaluated with respect to general morbi-mortality associated with the complete procedure, hematic losses during the procedure, transfusion requirements, and renal function (calculated by measuring preoperative and 48-hour postoperative serum creatinine levels). All patients reported having symptoms at the time of diagnosis, all of them had tumors measuring >13 cm in diameter (major). In all the cases, 100% technical success was obtained with the embolization and nephrectomy. The mean duration of surgery in the case of embolization with coils was 45 minutes, and 25 minutes in the case of embolization with Amplatzer. A mean volume of 115 mL of contrast medium was used in the case of embolization with coils, whereas for the other cases, a mean volume of 71 mL of iodinated contrast was used. Among all the patients, only two of them required to be cared at the intensive care unit during 24 hours. On an average, reported blood loss was 380 mL. During the procedure, two patients (28.6%) required a transfusion of two units of red cells. No cases of perioperative or postoperative mortality were reported. With respect to morbidity, only one patient (14.3%) experienced a complication in the form of a superficial infection of the surgical wound, which was later resolved by antibiotic therapy. One patient (14.3%) presented a slightly higher preintervention level of creatinine (1.42). Two patients (28.6%), both of whom underwent embolization by using coils, experienced deterioration of postoperative renal function. CONCLUSION: Preoperative embolization of the renal artery as a coadjuvant treatment option in high-risk renal neoplasia has clear technical benefits for the subsequent nephrectomy and also medical benefits for the patients. Performing both the procedures concomitantly as a single surgical act seems to retain the advantages of the embolization procedure, by reducing mortality rates and producing little associated morbidity. Technically, embolization with Amplatzer plugs seems to be faster and easier as compared with embolization with coils.