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.

Final results of the Endurant Stent Graft System in the United States regulatory trial.

OBJECTIVE: To report the 5-year outcomes from the Endurant Stent Graft System in the U.S. regulatory trial (bifurcated Endurant; Medtronic Santa Rosa, Calif). METHODS: The study was a prospective, multicenter, regulatory trial performed at 26 U.S. sites. From June 2008 to April 2009, 150 patients with abdominal aortic aneurysms (AAAs) were treated with the Endurant bifurcated graft. The main inclusion criteria included AAA diameter >5 cm (or 4-5 cm in diameter where the size increased more than 5 mm within the previous 6 months), neck length ≥10 mm, and neck angulation ≤60 degrees. A clinical events committee adjudicated all untoward events, and a core laboratory reviewed available imaging at 1, 6, 12, 24, and 60 months. Outcomes were compared with the Talent enhanced Low Profile System (eLPS) study for regulatory purposes. At 5 years, clinical follow-up was available on 94% and imaging on 87% of 101 eligible patients. RESULTS: At 5 years, all-cause mortality estimate by Kaplan-Meier was 17.7%, and freedom from aneurysm-related mortality was 99.2%. One aneurysm-related mortality was noted in a patient that refused treatment for a type I endoleak and died in year 4 from rupture. There were no endograft migrations, fractures, or open conversions. At 5 years, endoleaks were identified in 7/83 patients (8.4%) and included six type II endoleaks and one of indeterminate origin. Maximum AAA diameter decreased by more than 5 mm in 53/83 patients (63.9%), remained stable in 25/83 (30.1%), and increased >5 mm in 5/83 (6.0%). Eighteen AAA-related secondary interventions were required in 15 patients (11%): 12 for endoleak management, 4 for limb occlusions, 1 for stenosis, and 1 for thromboembolism. Four of 5 limb occlusions reported were in the first 6 months. Survival and reintervention rates were better than the Talent eLPS study, which was conducted under similar inclusion exclusion criteria. CONCLUSIONS: The 5-year outcomes of the Endurant Stent Graft System in the U.S. regulatory trial continue to be positive. The device appears to be durable with limited adverse events through 5 years. Comparison with an older generation device suggests improving outcomes with newer devices.

The pulmonary embolism risk score system reduces the incidence and mortality of pulmonary embolism after gastric bypass.

BACKGROUND: Pulmonary embolism (PE) is a leading cause of death after roux-en-Y gastric bypass (RYGB); therefore, current recommendations for prophylaxis may be inadequate. METHODS: We reviewed our first 1,341 patients (controls) who underwent RYGB and weighted factors that may have contributed to PE to arrive at a pulmonary embolism risk score (PERS). We postulated that more aggressive prophylaxis in higher risk patients might have reduced the incidence of PE. We tested our hypothesis by basing prophylaxis on the PERS in 1,652 subsequent RYGB patients (study group). Standard risk patients (PERS <4) were ambulated 2 hours after surgery, had application of intermittent compression devices, and received subcutaneous low-dose, unfractionated heparin (LDUH). Intermediate risk patients (PERS = 4) received standard prophylaxis and 3 weeks of postdischarge LDUH. High-risk patients (PERS >4) had postdischarge LDUH and a preoperative vena cava filter. RESULTS: The 0.36% incidence of PE (6 patients) in the study group was significantly lower (P <.05) than the 1% incidence (13 patients) in the controls. Three of 189 men in the control group died of PE, whereas there were no deaths from PE in 271 men in the study group (P <.05). CONCLUSION: The PERS may be an appropriate scoring system for determining preoperatively the level of risk for postoperative PE in RYGB patients. Basing prophylaxis on the level of risk reduces the incidence and mortality of PE and consumes resources judiciously.

Early and mid-term results of ruptured abdominal aortic aneurysms in the endovascular era in a community hospital.

OBJECTIVE: Endovascular repair (EVAR) has been increasingly used for ruptured abdominal aortic aneurysms (rAAAs), especially in major academic centers. The goal of this article is to report our results with an EVAR-first approach for rAAA which we adopted in 2001 in our community hospital. METHODS: All consecutive patients who underwent attempted repair for rAAA between February 2001 and July 2006 were analyzed. Only patients with computed tomographic or visual verification of extraluminal blood were included. RESULTS: A total of 40 patients (30 men; mean age, 76.4 +/- 7.2 years; range, 57-89 years) presented with rAAA. Thirty patients underwent attempted EVAR for rAAA, constituting 4.1% of all EVAR cases (n = 738), and 10 patients had attempted open repair. Twenty-one (53%) were transferred from another institution. Computed tomography was performed in 97.5%. On arrival to the emergency department, 43%% were hypotensive (systolic blood pressure <80 mm Hg). Transfemoral balloon occlusion was used in 12 cases (30%; 10 in the EVAR group and 2 in the open group). The length of operation was 128 +/- 35 minutes (range, 77-210 minutes) in EVAR cases. EVAR was completed in 93.3% (iliac anatomy and proximal endoleak caused open conversion in two cases). Out of the 10 open treated cases, 1 was converted to EVAR and survived. The grafts used for EVAR were AneuRx (n = 21), Zenith (n = 5), and Ancure (n = 4), and 97% were bifurcated. Five patients (16.6%) in the EVAR group died within 30 days (four required balloon occlusion). The mean length of stay was 9.1 +/- 6.2 days (range, 4-30 days) in survivors of EVAR. In the EVAR-treated group, two patients died (7 and 9 months; unrelated), and six of the surviving patients (23%) required secondary procedures (five femorofemoral bypasses for limb occlusions and one proximal cuff for a type I endoleak that caused repeat rupture) during a mean follow-up of 13.8 +/- 10.4 months (range, 3-39 months). The mortality rate was 40% (4/10) in patients who underwent open procedures during this period, with an overall mortality rate of 22.5% for all ruptures treated. The difference in 30-day mortality in the EVAR and open groups did not reach statistical significance (17% vs 40%; P = .19). In the entire cohort, hypotension (systolic blood pressure <80 mm Hg) on arrival and loss of consciousness were associated with 30-day mortality. Balloon occlusion was correlated with mortality in the EVAR-treated group (44% vs 4%; P = .019). The multivariate analysis using logistic regression showed that hypotension (odds ratio [OR], 7.4; 95% confidence interval [CI], 1.3-42.0; P = .025), loss of consciousness (OR, 37.5; 95% CI, 3.4-40.8; P = .003), and the need for balloon occlusion (OR, 5.2; 95% CI, 1.8-25.5; P = .042) were correlated with higher perioperative mortality, whereas age greater than 76 years, coronary artery disease, chronic obstructive pulmonary disease, hypertension, diabetes, renal insufficiency, and type of procedure did not. CONCLUSIONS: Our results show that EVAR is feasible with favorable outcomes in patients presenting with rAAA in a busy community hospital. There is a high secondary intervention rate, which can potentially be decreased by ensuring good iliac limb anatomy at the end of the procedure and by a closer follow-up.

Embolization as cause of bowel ischemia after endovascular abdominal aortic aneurysm repair.

OBJECTIVE: We investigated the incidence, cause, and outcome of large bowel and small bowel ischemia after endovascular abdominal aortic aneurysm (AAA) repair. METHODS: Medical records for all patients undergoing endovascular AAA repair from December 1999 to December 2003 were reviewed. The incidence, cause, and outcome of clinically detected postoperative bowel ischemia were analyzed. RESULTS: Seven hundred two endovascular AAA repairs were performed. In 10 patients (1.4%) acute bowel ischemia developed. Six of these patients sustained concurrent small bowel necrosis, and the remaining 4 had isolated colon ischemia. Seven patients underwent exploratory laparotomy. In 6 of these bowel resection was performed, and in 1 patient the ischemic bowel was unsalvageable. Of the 6 patients with small and large bowel ischemia, 4 had segmental or patchy necrosis, which was separated by normal-appearing intestine, and 1 had extensive ischemia that involved most of the small bowel and the entire colon, with pathologic evidence of microembolization. Three patients had preoperative occlusion of the inferior mesenteric artery. One had unilateral and 1 had bilateral hypogastric artery interruption. Five of the 6 patients with small bowel ischemia had thrombus or atheroma in the proximal aneurysmal necks. All patients with isolated colon ischemia survived. All 6 patients with concurrent small bowel ischemia died. CONCLUSION: The total incidence of clinically evident bowel ischemia after endovascular AAA repair is similar to that after open surgery. However, small bowel ischemia occurs more commonly in patients with endovascular repair, and is associated with extremely high mortality. The direct pathologic evidence and the patterns of segmental, skipped, or patchy ischemia in most patients imply that microembolization has an important role.