Midterm outcomes in patients undergoing endovascular repair of thoracic aortic aneurysms and penetrating atherosclerotic ulcers using the RelayPlus stent graft.

BACKGROUND: The Relay Thoracic Stent-Graft with Plus Delivery System (RelayPlus; Terumo Aortic, Sunrise, Fla) was designed to handle the curvature and tortuosity of the thoracic aorta. It was approved by the Food and Drug Administration in 2012; the postapproval study was stopped early because of adequate safety and efficacy data, and no difference was identified in experienced vs first-time users of RelayPlus. The purpose of this study was to report real-world outcomes of patients with thoracic aortic aneurysms and penetrating atherosclerotic ulcers (PAUs) undergoing thoracic endovascular aortic repair (TEVAR) with RelayPlus. METHODS: This is a prospective, multicenter, nonrandomized postapproval study that required the use of novice implanters in the United States. Primary and secondary end points included device-related adverse events (deployment failure, conversion to open repair, endoleaks, migration, rupture, and mortality) and major adverse events (stroke, paraplegia/paraparesis, renal failure, respiratory failure, and myocardial infarction), respectively. Continuous and categorical covariates were reported in means or medians and percentages, respectively. Kaplan-Meier survival estimates were used to report long-term TEVAR-related mortality, all-cause mortality, and reinterventions at 3 years. RESULTS: A total of 45 patients with mean age (standard deviation [SD]) of 73.5 (±7.20) years were treated for descending thoracic fusiform aneurysm (56%) or saccular aneurysm/PAU (44%). The patients were predominantly white (80.0%) and male (68.9%). Mean (SD) proximal neck, distal neck, and lesion lengths were 38.2 (±37) mm, 42.1 (±28) mm, and 103.8 (±74) mm, respectively. Mean (SD) aneurysm, proximal neck, and distal neck diameters were 53.9 (±13) mm, 31.3 (±4) mm, and 31.7 (±6) mm, respectively. Technical success was 100%. TEVAR-related mortality at 30 days was 4.4%; two patients died postoperatively, one of shock and the second of bilateral hemispheric stroke. No patient in the study had any conversion to open repair or post-TEVAR rupture. Two patients experienced three major adverse events, which included stroke (2.2%), paraplegia (2.2%), and respiratory failure (2.2%) at 30 days. Three-year freedom from TEVAR-related mortality, all-cause mortality, and reinterventions was 95.6%, 84.0%, and 97.2%, respectively. There were two type I endoleaks at 3 years: one type IB associated with no migration or aneurysm sac increase and one type IA associated with caudal migration of proximal neck and expansion of the proximal aorta. CONCLUSIONS: The RelayPlus postapproval study reported low operative mortality and morbidity and supported use of the device as a safe and effective thoracic aortic aneurysm and PAU endovascular treatment. Early midterm follow-up showed sustained freedom from TEVAR-related mortality in real-world practice. Follow-up continues to evaluate the durability of this endograft.

Anti-platelet and anti-hypertension medication use in patients with fibromuscular dysplasia: Results from the United States Registry for Fibromuscular Dysplasia.

Fibromuscular dysplasia (FMD), a non-inflammatory arterial disease, may lead to renovascular hypertension (HTN) and cerebrovascular disease. Little is known about medication use in FMD. Clinical features and medication use were reviewed in a national FMD registry (12 US sites). Medication usage was assessed in raw and adjusted analyses. Covariates included demographic characteristics, co-morbid conditions and vascular bed involvement. A total of 874 subjects (93.6% female) were included in the analysis. Mean age was 55.6±13.1 years, 74.5% had HTN, 25.4% had a history of transient ischemic attack or stroke, and 7.5% had a history of coronary artery disease (CAD). Renal and cerebrovascular arteries were affected in 70.4% and 74.7%, respectively. Anti-platelet agents were administered to 72.9% of patients. In multivariate analyses, factors associated with a greater likelihood of anti-platelet agent use were older age (OR=1.02 per year, p=0.005), CAD (OR=3.76, p=0.015), cerebrovascular artery FMD involvement in isolation (OR=2.31, p<0.0001) or a history of previous intervention for FMD (OR=1.52, p=0.036). A greater number of anti-HTN medications was evident in isolated renal versus isolated cerebrovascular FMD patients. Factors associated with a greater number of anti-HTN medications were older age (OR=1.03 per year, p<0.0001), history of HTN (OR=24.04, p<0.0001), history of CAD (OR=2.71, p=0.0008) and a history of a previous therapeutic procedure (OR=1.72, p=0.001). In conclusion, in FMD, medication use varies based on vascular bed involvement. Isolated renal FMD patients receive more anti-HTN agents and there is greater anti-platelet agent use among patients with cerebrovascular FMD. Further studies correlating medication use in FMD with clinically meaningful patient outcomes are necessary.

Safety and efficacy of carotid stenting in the very elderly.

BACKGROUND: Carotid artery stenting (CAS) has emerged as an alternative to carotid endarterectomy (CEA) in patients at high risk for complications from surgery. The very elderly (>or=80-year-old) are one subgroup of patients identified as being at increased risk for carotid surgery. However, there is concern that the very elderly are also at increased risk for complications of CAS. A stroke and death rate of 12% was reported in very elderly patients during the roll-in phase of Carotid Revascularization Endarterectomy versus Stent Trial (CREST). We are reporting on a large clinical series of CAS with independent neurological assessment in the very elderly. METHODS: Between 1994 and 2008, a consecutive series of 418 CAS patients (>or=80-year-old) were treated at four high-volume centers with extensive CAS experience. Independent neurologic assessment was performed after CAS procedures. Thirty-day follow-up information was available in 389 patients. RESULTS: The average age was 83.2 +/- 2.8 years. Most patients were male (63.2%), and the target lesion carotid stenosis was asymptomatic in two-thirds (68.2%) of patients. The majority of patients treated with CAS had a history of coronary artery disease (74.4%), hypertension (87.8%), and dyslipidemia (71.1%). One third (30.1%) were diabetic and more than half (56.5%) were current or former smokers. Embolic protection devices (EPD) were used in 78.7% of cases with the CAS procedure being performed before EPD availability being the most common reason for not using them. The overall 30-day incidence of stroke and death was 2.8% (11/389). The cumulative incidence of major cardiovascular events (stroke, death, or myocardial infarction) during that time period was 3.3% (13/389). CONCLUSIONS: This large series of CAS with independent neurologic assessment is convincing evidence that the very elderly (>or=80 years) can safely undergo CAS with stroke and death rates comparable to younger patients. The key to obtaining these excellent results is that CAS be performed by high volume, experienced operators who exercise restraint regarding patient selection.

Results of a multicenter trial for the treatment of traumatic vascular injury with a covered stent.

BACKGROUND: The safety and efficacy of endovascular treatment of arterial trauma using the Wallgraft Endoprosthesis was evaluated in a subgroup analysis of a prospective, multicenter, nonrandomized registry trial with a historical control to surgical management. Endpoints were exclusion success at procedure and at 12-months, primary patency and freedom-from-bypass at 12-months, and major adverse events. METHODS: Sixty-two patients were treated for arterial trauma from October 1997 to June 2003. The anatomic locations of the injuries were: iliac (33), subclavian (18), and femoral (11) arteries. Indication for treatment was perforation/rupture (33), acute pseudoaneurysm (10), AV fistula (16), and dissection (3). Exclusion and patency were assessed using arteriography, duplex ultrasound, CT, or MRA at postprocedure and 12-months. Major adverse event and mortality rates were compared with surgical intervention of arterial trauma using literature based objective performance criteria. RESULTS: The Wallgraft Endoprosthesis achieved postprocedure exclusion in 58 of 62 cases (93.5%). One-year exclusion rates were 91.3% iliac, 90.0% subclavian, and 62.3% femoral. One-year primary patency rates were 76.4% iliac, 85.7% subclavian, and 85.7% femoral. Freedom-from-bypass was achieved in 74.3% iliac and 100% femoral and subclavian injuries. The most common adverse events were stenosis (4.8%) and occlusion (6.5% early, 1.6% late). There were no device- or procedure-related deaths. Analysis of the literature revealed the rates and severity of complications are less than those associated with surgical repair. CONCLUSION: The Wallgraft Endoprosthesis for the treatment of traumatic arterial injuries offers a promising alternative to conventional operative repair with comparable patency and less major morbidity and mortality.

Waligraft endoprosthesis for the percutaneous treatment of femoral and popliteal artery aneurysms.

PURPOSE: To evaluate the safety and efficacy of the Wallgraft Endoprosthesis for the treatment of femoropopliteal artery aneurysms. METHODS: From October 1997 to April 2000, 17 patients (13 men; mean age 73.5 +/- 7.1 years) with 7 femoral and 13 popliteal artery aneurysms underwent percutaneous aneurysm exclusion using the Wallgraft Endoprosthesis as part of a larger clinical trial. The mean aneurysm diameters were 37.6 +/- 12.9 mm and 22.3 +/- 8.7 mm, respectively. RESULTS: Acute procedural success was 100% for femoral aneurysms and 92.3% (12/13) in the popliteal artery owing to one endoleak that resolved after 1 month. There were no complications, and the mean length of stay was 2.2 +/- 3.8 days. Six-month and 1-year aneurysm exclusion rates were 100% for both locations, but 4 (31%) popliteal stent-grafts thrombosed in follow-up. Three were recanalized, but the fourth underwent bypass grafting after 3 thrombotic episodes. The 1-year primary and secondary patency rates were both 100% for the femoral aneurysms and 69% and 92%, respectively, for popliteal repairs. No procedure or device-related deaths occurred. CONCLUSIONS: Treatment of aneurysms in the femoropopliteal segment appears to be safe and effective with the Wallgraft Endoprosthesis, although longer follow-up in a larger patient group will be needed to determine this technique's potential versus surgical repair.