Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal.

OBJECTIVE: This report presents the 30-day results of the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial and evaluates the safety and efficacy of ENROUTE Transcarotid NPS (Silk Road Medical Inc, Sunnyvale, Calif), a novel transcarotid neuroprotection system that provides direct surgical common carotid access and cerebral embolic protection via high-rate flow reversal during carotid artery stenting (CAS). METHODS: A prospective, single-arm, multicenter clinical trial was performed to evaluate the use of the ENROUTE Transcarotid NPS during CAS procedures performed in patients considered to be at high risk for complications from carotid endarterectomy. Symptomatic patients with ≥50% stenosis and asymptomatic patients with ≥70% stenosis were eligible to be treated with any U.S. Food and Drug Administration-approved carotid artery stent. The primary end point was the composite of all stroke, myocardial infarction (MI), and death at 30 days postprocedure as defined in the Food and Drug Administration-approved study protocol. Secondary end points included cranial nerve injury; 30-day stroke, death, stroke/death, and MI; acute device, technical, and procedural success; and access site complications. All major adverse events were adjudicated by an independent clinical events committee. RESULTS: Between November 2012 and July 2014, 208 patients were enrolled at 18 sites. Sixty-seven patients were enrolled as lead-in cases, and 141 were enrolled in the pivotal phase. In the pivotal cohort, 26% were symptomatic and 75% were asymptomatic. Acute device and technical success were 99% (140 of 141). By hierarchical analysis, the all-stroke rate in the pivotal group was 1.4% (2 of 141), stroke and death was 2.8% (4 of 141), and stroke, death and MI was 3.5% (5 of 141). One patient (0.7%) experienced postoperative hoarseness from potential Xth cranial nerve injury, which completely resolved at the 6-month follow-up visit. CONCLUSIONS: The results of the ROADSTER trial demonstrate that the use of the ENROUTE Transcarotid NPS is safe and effective at preventing stroke during CAS. The overall stroke rate of 1.4% is the lowest reported to date for any prospective, multicenter clinical trial of CAS.

Comparison of Clinical and Histologic Outcomes of Zirconia Versus Titanium Implants Placed in Fresh Sockets: A 5-Month Study in Beagles.

Purpose: This study evaluated the clinical and histomorphometric results of titanium (Ti) and custom-made zirconia (Zr) implants placed into fresh extraction sockets in beagles that did not receive oral hygiene attention or a softened diet during postoperative healing. Materials and Methods: The roughness of the Ti and Zr implant surfaces was assessed by confocal microscopy. In eight beagle dogs, four implants each (two Ti and two Zr) were placed in the distal sockets of the third and fourth premolars with the implant shoulder at the bone crest and subjected to submerged healing. Standardized radiographs were taken after placement and 5 months after placement (at sacrifice). Histologic and histomorphometric measurements were performed on nondecalcified histologic sections. The main outcome measures included implant survival, bone-implant contact (BIC), and bone loss on the buccal and lingual plates. Results: Topographic analysis showed significant differences between the Zr and Ti surfaces. Roughness was higher for Ti than for Zr implants, kurtosis was close to 3 for Ti, and skewness was negative for Zr. After 5 months, the mean BIC was similar for the Zr (57.0% ± 15.2%) and Ti (56.5% ± 14.4%) implants, and the most severe bone loss site was observed on the buccal wall. The risk of failure was significantly higher for the Zr (43.8%) than for the Ti (12.5%) implants. Conclusion: The implant failure rate for the Zr implants was 3.5 times higher than that of the Ti implants. This may be partially explained by the less favorable topography of the Zr implants, which had, on average, significantly lower roughness (Ra = 0.85 ± 0.04 µm), negative skewness of the surface profile (-1.56 ± 0.27), and higher kurtosis (7.88 ± 1.99).