Primary 3-Month Outcomes of a Double-Blind Randomized Prospective Study (The QUEST Study) Assessing Effectiveness and Safety of Novel High-Frequency Electric Nerve Block System for Treatment of Post-Amputation Pain.

Purpose: This multicenter, randomized, double-blinded, active sham-controlled pivotal study was designed to assess the efficacy and safety of high-frequency nerve block treatment for chronic post-amputation and phantom limb pain. Patients and Methods: QUEST enrolled 180 unilateral lower-limb amputees with severe post-amputation pain, 170 of whom were implanted with the Altius device, were randomized 1:1 to active-sham or treatment groups and reached the primary endpoint. Responders were those subjects who received ≥50% pain relief 30 min after treatment in ≥50% of their self-initiated treatment sessions within the 3-month randomized period. Differences between the active treatment and sham control groups as well as numerous secondary outcomes were determined. Results: At 30-min, (primary outcome), 24.7% of the treatment group were responders compared to 7.1% of the control group (p=0.002). At 120-minutes following treatment, responder rates were 46.8% in the Treatment group and 22.2% in the Control group (p=0.001). Improvement in Brief Pain Inventory interference score of 2.3 ± 0.29 was significantly greater in treatment group than the 1.3 ± 0.26-point change in the Control group (p = 0.01). Opioid usage, although not significantly different, trended towards a greater reduction in the treatment group than in the control group. The incidence of adverse events did not differ significantly between the treatment and control groups. Conclusion: The primary outcomes of the study were met, and the majority of Treatment patients experienced a substantial improvement in PAP (regardless of meeting the study definition of a responder). The significant in PAP was associated with significantly improved QOL metrics, and a trend towards reduced opioid utilization compared to Control. These data indicate that Altius treatment represents a significant therapeutic advancement for lower-limb amputees suffering from chronic PAP.

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.

Secure fixation following EVAR with the Powerlink XL System in wide aortic necks: results of a prospective, multicenter trial.

PURPOSE: Endovascular stent graft repair of abdominal aortic aneurysms (AAA) with the Endologix Powerlink System (Endologix, Inc, Irvine, Calif) has been shown to be a safe and effective alternative to open surgery in patients having an aortic neck diameter of up to 26 mm. We assessed the safety and effectiveness of AAA repair in patients with wide aortic necks (up to 32 mm in diameter) using the Powerlink XL System. METHODS: Between September 2005 and June 2008, a prospective, multicenter, pivotal US Food and Drug Administration trial of the Powerlink XL System for endovascular aneurysm repair was conducted at 13 centers. Using a sizing algorithm based on computed tomography scan (CT)-based measurements, a total of 78 patients (N = 60 [pivotal trial]; N = 18 [continued access]) presenting with AAA and an infrarenal aortic neck up to 32 mm in diameter received a bifurcated stent graft via anatomical fixation at the aortoiliac bifurcation and proximal sealing with a Powerlink XL infrarenal proximal extension stent graft. Postoperatively, results were assessed with contrast-enhanced CT scans and abdominal x-rays at one, six, and 12 months, with continued annual follow-up to five years. RESULTS: Predominantly male (91%), patients presented at a mean age of 73 +/- 8.6 years with mean maximum aortic neck and AAA diameters of 31 +/- 1.9 mm (range, 25 to 32 mm) and 5.7 +/- 1.0 cm (range, 4.3 to 10 cm), respectively. Challenging infrarenal aortic neck anatomy, defined as the presence of severe thrombus and/or reverse taper, was present in 85% of patients. Technical success was achieved in 98.7% of patients, with one patient requiring femoral-femoral bypass intraoperatively. Aneurysm exclusion was achieved in 100% of patients over a mean procedure time of 129 +/- 66 minutes. Patients were discharged at a mean of 2.2 days postoperatively. At the one-month CT scan, the independent core lab identified a Type II endoleak in 13 patients, distal Type I and Type II endoleak in one patient, and unknown endoleak in three patients. At 30 days, there were no deaths, conversions, ruptures, or migrations. Through one year follow-up, Type II endoleak predominated (9/10 patients with endoleak), with one proximal Type I and no Type III, IV, or unknown endoleak; no conversions, ruptures, or migrations have been observed. The one-year all-cause mortality rate was 6.4%, with 100% freedom from aneurysm-related mortality. Secondary procedures were performed within one year in five patients (6.4%) for treatment of proximal Type I endoleak (n = 2), proximal Type I/Type II endoleak (n = 1), and distal Type I endoleak (n = 2). Reduced or stable aneurysm sac diameter at one year is observed in 96% of patients. CONCLUSIONS: The combination of an anatomically-fixed Powerlink bifurcated stent graft and a Powerlink XL infrarenal proximal extension appears safe and effectively excludes aneurysms in patients with wide aortic necks. These results suggest that fixation at the aortic bifurcation can provide secure fixation for patients with large diameter diseased proximal aortic necks.