Systematic Review and Patient-Level Meta-analysis of the Streamliner Multilayer Flow Modulator in the Management of Complex Thoracoabdominal Aortic Pathology.

PURPOSE: To examine the safety and short-term efficacy of the Streamliner Multilayer Flow Modulator (SMFM) in the management of patients with complex thoracoabdominal aortic pathology who are unfit for alternative interventions. METHODS: Biomedical databases were systematically searched for articles published between 2008 and 2015 on the SMFM. A patient-level meta-analysis was used to evaluate aneurysm-related survival. Secondary outcomes were all-cause survival, stroke, spinal cord ischemia, renal impairment, and branch vessel patency. Other considerations were the impact of compliance with the instructions for use (IFU) on clinical outcome. Mean values and Kaplan-Meier estimates are presented with the 95% confidence interval (CI). RESULTS: Fifteen articles (3 multicenter cohort studies, 3 observational cohort studies, and 9 case reports) were included, presenting 171 patients (mean age 68.8±12.3 years; 139 men). The mean aneurysm diameter was 6.7±1.6 cm (95% CI 6.4 to 6.9 cm). Technical success reported in 15 studies was 77.2%. Aneurysm-related survival at 1 year was 78.7% (95% CI 71.7% to 84.4%). One-year all-cause survival was 53.7% (95% CI 46.0% to 61.3%). There were no reported cases of spinal cord ischemia, renal insult, or stroke. CONCLUSION: The SMFM can be safely utilized in some patients with complex thoracoabdominal pathologies provided operators adhere to the IFU. The SMFM is a novel technology with no long-term published data on its sustained effectiveness and a lack of comparative studies. Randomized clinical trials, registries, and continued assessment are essential before this flow-modulating technology can be widely disseminated.

Hybrid repair of thoracic aortic lesions for zone 0 and 1 in high-risk patients.

PURPOSE: Some patients with aortic arch or descending thoracic aorta pathologies are not suited for open repair because of comorbidities that may increase their risk of procedural complications or death. Endovascular approaches may also be difficult when there are inadequate proximal landing zones in the aortic arch. We report our experience using rerouting techniques with bypass, stenting of the branches, or a combination of both to create a landing area in zones 0 and 1 of the aortic arch. METHODS: Since November 2002, thoracic aortic endoluminal grafts were placed in 38 patients in whom the endograft was deployed in zone 0 (n = 27) or zone 1 (n = 11). A retrospective review is included. RESULTS: There were 11 women and 27 men with a mean age of 65.4 years (range 38-88). Aortic pathology included 12 Stanford type A dissections, 10 aortic arch aneurysms, 8 Stanford type B dissections, 3 descending thoracic aortic aneurysms, 2 aortobronchial fistulas, 1 innominate artery aneurysm and 2 aortic arch pseudoaneurysms. In zone 0, 21 had thoracic debranching with an ascending bypass, three patients had a remote-inflow and three patients had a chimney-stent with carotid-carotid bypass. In zone 1, five patients had a carotid-carotid bypass, one patient had an aortic to left common carotid artery (LCCA) bypass and five patients had chimney-stent on the LCCA. Fifty-eight percent of the patients were symptomatic and 26% emergent. Three patients required hemodialysis postoperatively (7.9%), 18 patients (47.4%) required prolonged mechanical ventilation for respiratory insufficiency. Paraplegia occurred in one patient (2.7%), and five patients suffered a cerebrovascular accident (13.1%). There were four early type I and two type II endoleaks. Overall 30-day mortality was 23.7%. CONCLUSIONS: The hybrid approach for repair of the aortic arch pathologies is feasible in patients unfit for open repair. We present the results of performing different techniques to treat the aortic arch with hybrid repair with antegrade or retrograde inflow, stenting of the branches or a combination of both. Long-term results are unknown, and larger series results and comparative studies are needed to determine safety and efficacy.

Institutional differences in endovascular aneurysm repair and aneurysm morphology.

BACKGROUND: Variability exists between institutions in the application of endovascular aneurysm repair (EVAR). This study compares patient-specific variables from a high-volume North American institution with one from the UK. METHODS: One hundred consecutive patients from each institution were studied. All were treated for an intact, infrarenal aortic aneurysm. Patient characteristics and aneurysm-related variables, measured from computed tomography according to Society for Vascular Surgery (USA) reporting standards, were examined. RESULTS: The median (range) age of the American patients was 74 (55-97) years and that of the British patients, 73 (49-89) years. There were 78 men in the American group and 79 men in the British group. All American patients were treated by EVAR compared to 11 % of the British group. Mean (SD) aneurysm diameter for the former was 55 (9) mm and for the latter 64 (11) mm (P < 0.001). While there was no difference in mean diameter of the infrarenal aortic neck (P = 0.918), the aneurysms of British patients (22 %) were more likely to be angulated >60° than those of the American patients (11 %) (P = 0.039). Furthermore, the mean (SD) length of infrarenal aortic neck was shorter in the British patients [21 (11) mm] compared to the American group [25 (12) mm] (P = 0.003). The mean diameter of the common iliac arteries was larger in the British patients than in the American group (P < 0.001). Mean external iliac artery diameter was no different between the groups (P = 0.507). CONCLUSIONS: This group of British patients have a more advanced pattern of aneurysm morphology than American patients of similar age. This difference may, in part, explain variability in the application of EVAR.

Report on the results of thoracic endovascular aortic repair for acute, complicated, type B aortic dissection at 30 days and 1 year from a multidisciplinary subcommittee of the Society for Vascular Surgery Outcomes Committee.

OBJECTIVE: This study analyzed 1-year outcome after thoracic endovascular aortic repair (TEVAR) in patients with complicated type B aortic dissection (cTBAoD) who had rupture or malperfusion and symptom onset ≤14 days (acute), 15 to 30 days (subacute), and 31 to 90 days (chronic) until required intervention. The main focus of this report is primarily on the acute cohort. METHODS: Clinical data were systematically collected from five physician-sponsored investigational device exemption (IDE) clinical trials between 2000 and 2008 using standardized definitions and forms. Adverse events were reported early (≤30 days) and late (>30 days) by body system. Major adverse events included death, stroke, myocardial infarction, renal failure, respiratory failure, paralysis, and bowel ischemia. RESULTS: There were 99 cTBAoD patients: 85 were acute, 11 were subacute, and 3 were chronic. Among the acute patients, 31.8% had rupture and 71.8% had malperfusion, including 55.7% lower extremity, 36.1% renal, 19.7% visceral, 8.2% other, and 3.3% spinal cord (patients may have more than one source). Rupture and malperfusion were both reported for three acute patients. Additional findings for the acute cohort included pain (76.5%), hypertension (43.5%), and bleeding (8.2%); comorbidities included hypertension (83.5%), current/past smoking history (69.8%), and diabetes (12.9%). The main focus of this analysis was the acute cohort (n = 85). Age averaged 59 years (72.9% male). Early adverse events included pulmonary (36.5%), vascular (28.2%), renal (25.9%), and neurologic (23.5%). Early major adverse events occurred in 37.6% of patients, including death (10.6%), stroke (9.4%), renal failure (9.4%), and paralysis (9.4%); late adverse events included vascular (15.8%), cardiac (10.5%), gastrointestinal (6.6%), and hemorrhage (5.3%). The point-estimate mortality rate was 10.8 (95% confidence interval [CI], 4.1-17.5) at 30 days and 29.4 (95% CI, 18.4-40.4) at 1 year, when 34 patients remained at risk. CONCLUSIONS: Emergency TEVAR for patients with cTBAoD (malperfusion or rupture) provided acceptable mortality and morbidity results out to 1 year. Manufacturers can use this 30-day mortality point-estimate of 10.8 (95% CI, 4.1-17.5) for the acute cohort to establish a performance goal for use in single-arm commercial IDE trials if the Food and Drug Administration and other regulatory bodies concur.

Report on endograft management of traumatic thoracic aortic transections at 30 days and 1 year from a multidisciplinary subcommittee of the Society for Vascular Surgery Outcomes Committee.

OBJECTIVES: The Society for Vascular Surgery Outcomes Committee, including ad hoc members from Society of Thoracic Surgeons, American Association of Thoracic Surgery, and Society for Interventional Radiology, collected outcomes of patients with traumatic thoracic aortic transections treated with endovascular grafts. Results through 1 year of follow-up are reported. METHODS: Data from five physician-sponsored investigational device exemption clinical trials from 2000 to 2008 were entered using standardized forms and definitions. Adverse events were reported early (≤30 days) and late (>30 days) by body system. Major adverse events included one or more of the following: death, stroke, myocardial infarction, renal failure, respiratory failure, paralysis, or bowel ischemia. RESULTS: There were 60 symptomatic patients (68.3% men; mean age, 46 years) with traumatic aortic transections, of which 97% were due to a motor vehicle accident and 3% were related to other blunt trauma. The average total injury severity score was 39, most with involvement of the chest and abdomen. The average surgical time was 125 minutes. The mean hospital length of stay was 17 days. Associated procedures for the management of nonaortic injuries occurred in 51.7%. All-cause mortality was 9.1% at 30 days and 14.4% at 1 year. One or more major adverse events occurred in 23.3% of the patients, major adverse events occurred early in 20.0% and late in 3.6%. Death accounted for 41.7% of the early and all of the late major adverse events. Early adverse events included 16.7% pulmonary, 13.3% neurologic, and 11.7% vascular complications. Late adverse events included one patient (1.8%) with pulmonary failure and one patient (1.8%) who died of an unknown cause. CONCLUSIONS: One-year results of endograft placement for the management of patients with traumatic aortic injury are acceptable. Most cases treated were due to motor vehicle accident and associated with multiple coexisting injuries. Approximately three-quarters of the deaths occurred ≤30 days, indicating the acute severity of the condition. Although the relatively low rates of adverse and major adverse events are consistent with what is anticipated in an otherwise healthy population, future device and procedural developments may facilitate improved outcomes in the future.

Endovascular management of malperfusion in acute type B aortic dissections.

PURPOSE: To examine the feasibility, efficacy, and midterm results of endovascular stent-graft management of acute type B aortic dissection complicated by renal, visceral, or lower limb malperfusion. METHODS: A retrospective review was conducted to identify all patients with acute type B dissection treated endovascularly at a single center between 1998 and 2009. Of the 85 patients identified, 23 (27%) consecutive patients (20 men; mean age 60.9 ± 11.6 years) presented with clinical and imaging evidence of end-organ malperfusion: 7 (30%) renal, 6 (26%) lower limb, 4 (17%) renal and lower limb, 3 (13%) visceral, and single cases of renal/visceral, renal/lower limb/spinal cord, and renal/visceral/spinal cord/lower limb. RESULTS: All patients had stent-graft coverage of the proximal entry tear; 5 (22%) patients required additional branch vessel stenting, and 2 (9%) had femorofemoral bypass graft. Successful correction of malperfusion was achieved in 21 (91%) patients. In 1 patient, ischemia in the lower limb was resolved but not in the left kidney; the other patient had an ischemic but viable lower limb and did not require any additional intervention. Thirty-day mortality was 9% (2/23 patients). The incidences of postoperative stroke and paraplegia were 17% (4/23) and 9% (2/23), respectively. The 21 survivors were followed for 17.2 ± 15 months; during this period, 1 patient died, 1 was lost to follow-up, and 5 patients underwent additional open or endovascular procedures. CONCLUSION: Endovascular coverage of the proximal entry tear in acute type B dissections complicated by end-organ malperfusion resulted in correction of malperfusion in the majority of patients. It is a reasonable first line of treatment, but its superiority must be assessed in comparison with other techniques, such as fenestration.

Inherent problems with randomized clinical trials with observational/no treatment arms.

Randomized clinical trials (RCTs) offering an observation/no treatment (OBS/NoRx) arm as control and which are focused on the management of a condition with potentially life-threatening consequences, however small the risk, often experience a significant rate of crossover to treatment by those randomized to the OBS/NoRx arm. Results of these trials when analyzed on intent-to-treat basis often fail to resolve the issue at which they were directed. The authors have observed this in trials of abdominal aortic aneurysms with this design and use these to exemplify the dilemmas RCTs of such design create, with crossovers ranging from 27% to over 60% (EVAR II, UKSAT, ADAM, PIVOTAL). Results of these trials are frequently used as level I medical evidence and their potential impact on clinical decision making and reimbursement can be quite significant and long-lasting. Recommendations regarding trial end points and suggestions to mitigate the high crossover effect are offered. It may be that some clinical conditions dealing with potentially life-threatening problems should not be studied in randomized prospective clinical trials containing an OBS/NoRx arm.

Endovenous thermal ablation of superficial venous insufficiency of the lower extremity: single-center experience with 3000 limbs treated in a 7-year period.

PURPOSE: To demonstrate that endovenous thermal ablation is not only effective and safe but also a durable treatment in patients with symptomatic varicose veins. METHODS: From February 2002 to February 2009, 2354 patients (1836 women; mean age 53 years, range 15-95) with symptomatic varicose veins in 3000 limbs underwent endovenous laser ablation (EVLA) or radiofrequency ablation (RFA). The majority of treated vessels were the great saphenous veins (GSV; 2619, 87.3%); 269 (8.9%) small saphenous veins (SSV) and 112 (3.8%) accessory saphenous veins (ASV) were also treated, all in outpatient procedures under local intra-compartmental anesthesia. An ultrasound evaluation was performed within 2 weeks of the procedure to evaluate vein occlusion, vein wall thickness, and clot extension into the deep vein. In a long-term evaluation involving the first 165 patients treated from February 2002 to January of 2003, 105 (64%) patients [126 (67%) of the 188 eligible limbs] were followed annually with clinical evaluation, duplex ultrasound, and symptom/satisfaction assessment over a mean 6.7 years. RESULTS: Treatment of 3000 limbs involved the use of EVLA in 2841 (2460 GSVs, 269 SSVs, and 112 ASVs) and RFA in 159 GSVs. Post-procedure duplex ultrasound found 57 (2.0%) veins recanalized or incompletely occluded [51 (2%) treated with EVLA and 6 (3.7%) with RFA] in patients treated for GSV or ASV incompetence. In the 269 SSVs treated (all with EVLA), 18 (6.7%) limbs demonstrated incomplete occlusion. Overall, both EVLA and RFA procedures were well tolerated, with minimal complications. In the longitudinal assessment of the 105 patients (126 limbs) participating in annual follow-up for a mean 6.7 years, the overall rate of satisfaction, symptom relief, and absence of varicosities was 86%. CONCLUSION: Endovenous ablation of saphenous vein has proven to be an effective, safe, and very durable procedure.

Carotid revascularization using endarterectomy or stenting systems (CaRESS): 4-year outcomes.

PURPOSE: To examine the 4-year outcomes from Carotid Revascularization using Endarterectomy or Stenting Systems (CaRESS) in light of the current reimbursement guidelines for carotid artery stenting (CAS) from the Centers for Medicare and Medicaid Services (CMS). METHODS: CaRESS was designed as a prospective, nonrandomized comparative cohort study of a broad-risk population of symptomatic and asymptomatic patients with carotid stenosis. In all, 397 patients (247 men; mean age 71 years, range 43-89) were enrolled and underwent carotid endarterectomy (CEA; n = 254) or protected CAS (n = 143). More than 90% of patients had >75% stenosis; two thirds were asymptomatic. The primary endpoints included (1) all-cause mortality, (2) any stroke, and (3) myocardial infarction (MI), as well as the composite endpoints of (4) death and any nonfatal stroke and (5) death, nonfatal stroke, and MI. The secondary endpoints were restenosis, repeat angiography, and carotid revascularization. All patients were classified with respect to surgical risk, symptom status, and stenosis grade based on criteria published by the CMS. In addition, separate analyses were performed comparing genders and octogenarians to those <80 years old. RESULTS: No significant differences in the primary outcome measures were found between the CEA and CAS groups in the 4-year analysis. The incidences of any stroke at 4 years were 9.6% for CEA and 8.6% for CAS (p = 0.444); when combined with death, the composite death/nonfatal stroke rates were 26.5% for CEA versus 21.8% for CAS (p = 0.361). The composite endpoint of death, nonfatal stroke, and MI at 4 years was 27.0% in CEA versus 21.7% in CAS (p = 0.273) patients. The secondary endpoints of restenosis (p = 0.014) and repeat angiography (p = 0.052) were higher in the CAS arm. There were no differences in any of the subgroups stratified according the CMS guidelines or in the gender comparison. Four-year incidences of death/nonfatal stroke and death/nonfatal stroke/MI were higher in the CEA arm among patients <80 years of age (p = 0.049 and p = 0.030, respectively). There were no significant differences between these incidences in the octogenarian subgroup. CONCLUSION: The risk of death or nonfatal stroke 4 years following CAS with distal protection is equivalent to CEA in a broad category of patients with carotid stenosis. There were no significant differences in stroke or mortality rates between high-risk and non-high-risk patients and no differences in outcomes between symptomatic and asymptomatic patients. After 4 years, CAS had a 2-fold higher restenosis rate compared to CEA. The risk of death/stroke or death/stroke/MI appears to be higher following CEA than CAS among patients <80 years of age, yet there is no statistically significant relationship between death, stroke, or MI among octogenarians.

Symptomatic seroma after open abdominal aortic aneurysm repair.

Seroma following open abdominal aortic aneurysm repair has rarely been described. The majority of cases in the literature have been associated with use of polytetrafluoroethylene grafts. Here, we present a patient with a very large, symptomatic periaortic graft seroma 10 years after conventional (open) repair. The etiology of such seromas is of significant interest in endovascular aortic repair.

"Cracking and paving": a novel technique to deliver a thoracic endograft despite ilio-femoral occlusive disease.

BACKGROUND: The use of endoluminal grafts to treat thoracic aortic aneurysms has been associated with a decreased morbidity and mortality compared with open thoracic aortic aneurysm repair. High-risk surgical patients with ilio-femoral occlusive disease may not be amenable to general anesthesia and the construction of a retroperitoneal conduit. METHODS AND RESULTS: We report the use of a novel technique consisting of cracking and paving of the ilio-femoral vessels with balloon angioplasty, followed by deployment of an endoconduit to deliver an endoluminal graft under local sedation to treat a high-risk 80-year-old patient with a thoracic aneurysm. CONCLUSION: High-risk surgical patients with iliofemoral disease can undergo endoluminal graft therapy to threat thoracic aortic aneurysms.

Endovascular management of a large post-traumatic iliac arteriovenous fistula: utilization of a septal occlusion device.

We describe the management of a large iliac arteriovenous fistula in a 48-year-old patient presenting with heart failure and pulmonary hypertension. The presumptive etiology was a left-lower back stab wound approximately 20 years earlier. A large communication between the left internal iliac artery and the left internal iliac vein was successfully treated with a septal occlusion device.

Technical tips for thoracic aortic endografting.

Thoracic aortic endografting is proving to be extremely useful for correcting a variety of lesions with few complications. Endovascular intervention avoids sternotomy or thoracotomy, the use of chest tubes, respirators, and general anesthesia, and limits blood loss. Compared with traditional open surgery, complications such as paraplegia, renal failure, and cardiac and pulmonary difficulties are minimized; hospital and rehabilitation times are also reduced. Selection of patients on the basis of favorable anatomy and pathology for a specific device is critical to procedural success. In some cases, a retroperitoneal conduit may be useful. In addition, left carotid-subclavian bypass or a transposition of the left subclavian artery to the left common carotid artery may be necessary before endografting, and spinal cord fluid drainage may be important when there is potential for cord ischemia.

Retrograde type A dissection after endovascular stenting of the descending thoracic aorta. Is the risk real?

OBJECTIVE: Retrograde type A dissection during or after endoluminal graft repair of the descending thoracic aorta is a potentially lethal complication unique to thoracic endografting. Our aim is to increase its awareness and to review possible etiological factors. METHODS: Two hundred and eighty-seven patients with different thoracic aortic pathologies were treated with endovascular prostheses over the last 6 years (February 2000 to March 2006) under a single-site protocol. A retrospective review was conducted to identify any retrograde aortic dissections by both chart and film review. Factors that may have contributed to its formation were also documented. This population was analyzed for the complication of retrograde aortic dissection as well as the factors related to its occurrence. RESULTS: Seven patients (2.4%) with a gender distribution of three males and four females experienced a retrograde type A dissection within this sample at a median of 202 days. The mean age was 74 years (range 53-83). Aortic pathologies included aortic dissections (n=6) and thoracic aortic aneurysm (n=1). There were (n=3) 43% retrograde type A dissections identified within the perioperative period. Balloon angioplasty was performed in 71.4% (n=5). Two female patients (28.6%) had this event identified within their initial hospitalization with fatal consequences. Overall mortality was 57% (n=4) with extension of dissection the primary cause of death n=3 and open surgical repair (n=1) after an extension of retrograde dissection. CONCLUSIONS: Female gender, use of stent-grafts for dissection and possible aggressive balloon angioplasty may play a role in the cause of retrograde type A dissection. A close surveillance program is recommended when using thoracic endografts outside the recommended device instructions for use.

Endovascular reconstruction of a new aortoiliac bifurcation to manage a ruptured thoracoabdominal pseudoaneurysm in a Marfan patient.

Traditional open surgical repair for aortic rupture from a thoracoabdominal pseudoaneurysm is associated with a high morbidity and mortality. The use of advanced intravascular imaging and endovascular techniques permits selection and customizing endoluminal graft components to treat such catastrophic events in high-risk surgical patients. We report the successful management of a ruptured thoracoabdominal pseudoaneurysm with an endovascular approach.

Endoluminal graft therapy for the treatment of an aorto-bronchial fistula: mid-term follow-up.

Open surgical repair of aorto bronchial fistulas is associated with a high morbidity and mortality. Endovascular stent graft as an alternative therapy, though limited, has produced acceptable initial results, but few reports of mid-term follow-up are available. We report the mid-term results with the use of an endograft to treat a patient with both an aorto bronchial fistula and a contained rupture of the thoracic aorta.

Endovascular management of a descending thoracic mycotic aneurysm: mid-term follow-up.

Open surgical repair of mycotic aneurysm is associated with a high surgical morbidity and mortality. Endovascualr graft management of thoracic aortic aneurysm has been associated with a less surgical risk. The role of endovascular graft repair of mycotic aneurysm remains controversial since graft material remains in contact with possible infected tissue. We report the marked thrombosis and marked regression of a thoracic mycotic aneurysm with an endovascular graft at mid-term follow-up.

Hybrid interventions for the treatment of the complex aortic arch.

Open surgical replacement of the ascending and arch aorta is a formidable operation that requires extracorporeal circulation and hypothermic circulatory arrest, and may be associated with increased morbidity and mortality. In recent years, endoluminal graft therapy has been increasingly applied to the treatment of thoracic aortic pathologies with decreased morbidity, mortality, and risk of paraplegia. The hybrid approach combines various extra-anatomic debranching procedures with endoluminal graft therapy, providing a less invasive approach for the management of various complex thoracic arch pathologies without the morbidity and mortality associated with hypothermic circulatory arrest. This article reviews the hybrid approach for the management of various complex aortic arch pathologies.