A Single Center Experience with the Roadsaver Stent

Abstract

Introduction - The main carotid artery stenting (CAS) Achilles’ heel is the embolization. But most of this embolic events take place postprocedure, when there is no protection device. The Roadsaver carotid artery stent is a double layer micromesh stent which reduces embolization and plaque prolapse not only during the procedure. The CLEAR-ROAD study shows promising results. Using an embolic protection device added to the Roadsaver stent could improve the previous results of CAS. The aim of this study is to report our early results of the first patients treated with the Roadsaver stent in our center. Methods - A prospective registry was done between 1st January 2016 and 4th April 2017. 23 patients with an internal carotid artery stenosis diagnosed by duplex scan and that were at high risk for surgery because of combination of factors, including coronay artery disease, hostile anatomy or contralateral disease were treated with an embolic protection device and the Roadsaver stent. Every patient was assessed neurologically and evaluated with duplex ultrasound before and 24 hours and a month after the intervention. Results - 11 patients were symptomatic and 12 asymptomatic. In 19 patients, transcarotid carotid angioplasty revascularization (TCAR) technique with the ENROUTE device was used as embolic protection. In four patients transfemoral approch was performed: three with MOMA device and one with a distal filter. Thirteen patients were operated under local anaesthesia and tolerated flow reversal. Ten patients were operated under general anaesthesia. Technical success was achieved in all patients. One patient suffered a postintervention intracerebral hematoma that required sugery. One patient of the transfemoral group developed a minor stroke that recovered completely. Any patient developed a myocardial infarction. On the 24 hour post intervention duplex scan we observed a complete common carotid artery and internal carotid artery acute occlusion in one patient of the TCAR group, without any neurological repercussion. The rest 22 patients had no plaque prolapse in the postoperative and 30 day duplex scan. Postintervention neurological evaluation remained unchanged in all patients except for the one that suffered the intracerebral hematoma and the one that suffered the minor stroke. Conclusion - The Roadsaver stent associated with an embolic protection device is a safe alternative and could improve the CLEAR-ROAD results in CAS. Further studies including more patients are needed.