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.

Evaluation of functionality and biological response of the multilayer flow modulator in porcine animal models.

BACKGROUND: This study outlines the use of non-aneurysmal porcine animal models to study device functionality and biological response of the Multilayer Flow Modulator (MFM) (Cardiatis, Isnes, Belgium), with an emphasis on preclinical device functionality and biological response characteristics in an otherwise healthy aorta. METHODS: Twelve animals were implanted with the study device in the abdominal aorta, in 6 animals for 1 month and 6 animals for 6 months. Upon completion of the study period, each animal underwent a necropsy to examine how the implanted device had affected the artery and surrounding tissue. Neointima and stenosis formation were recorded via morphometry, and endothelialization via histopathological analysis. RESULTS: The MFM devices were delivered to their respective implantation sites without difficulty. Six of the implanted stents were oversized with percentages ranging from 2.6% to 18.8%. Statistical analysis was carried out and showed no significance between the regular sized stent group and oversized stent group for neointimal area (P=0.17), neointimal thickness (P=0.17), and percentage area stenosis (P=0.65). Histopathological findings showed in most areas flattened endothelium like cells lined the luminal surface of the neointima. Scanning electron microscopy also showed the devices were well tolerated, inciting only a minimal neointimal covering and little fibrin or platelet deposition. Neointimal thickness of 239.7±55.6 µm and 318.3±130.4 µm, and percentage area stenosis of 9.6±2.6% and 12.6±5% were recorded at 1 and 6 months respectively. No statistical differences were found between these results. CONCLUSION: The MFM devices were delivered to their respective implantation sites without difficulty and incited little neointimal and stenosis formation in the aorta, affirming its functionality and biocompatibility.

Will our training programs meet the challenges of increasingly complex endovascular aortic surgery?

It has been more than 2 decades since endovascular therapies appeared for the treatment of vascular disease. With each new enhancement in a therapeutic approach has come the demand for training to assure competence in the clinical setting. In the early days when the technology was relatively simple, training within the specific specialty through established training programs (eg, residencies, fellowships) was effective. However, today's endovascular treatment of complex aortic disease, as well as other vascular pathologies, is presenting demands that the current system cannot meet. New technologies will demand multispecialty collaboration, so current training programs must be altered if we are to meet the demands in education for future aortic interventions. This personal perspective reviews the evolution of endovascular therapy and the impact of product development's changing landscape on training. A new training paradigm must concentrate on centers of excellence with maximum flexibility to meet the needs and demands of our young trainees. It is vital that this approach be global, disease-focused, and linked to developments in epigenomics.

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.

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.

Mejores resultados en ruptura de aneurismas de aorta abdominal manejados con reparación endovascular: Algoritmo sugerido / Improved outcome of ruptured abdominal aortic aneurysms managed with endovascular repair: A suggested algorithm

Antecedentes: El propósito de este estudio es comparar la morbilidad y la mortalidad tanto de la reparación abierta (RA) como endovascular de la ruptura del aneurisma aórtico abdominal(rAAAs); y de presentar un algoritmo para el tratamiento y evaluaciones de la tomografía computarizada (CT) para determinar el uso de un balón oclusivo supra-celíaco. Métodos: Una revisión gráfica retrospectiva se realizó de los rAAAs tratados ya sea con reaparicióna cielo abierto (RA), ya sea con reparación aórtica endovascular (EVAR) entre junio de 1998 y junio de 2009. Se informaron las co-morbilidades, los datos peri-procedimientos y tanto la morbosidad como la mortalidad. Las TC se revisaron desde el uso inicial del balón oclusivo (Marzo de 2001) a fin de evaluar el hematoma retroperitoneal. Se desarrolló un algoritmo para determinarcuándo el balón oclusivo se debería implementar. El test exacto de Fisher, el t-test, y el test log rank fueron los que se utilizaron para el análisis estadístico.Resultados: Entre junio de 1998 y junio de 2009, 105 pacientes, 75 (71.4%) hombres, edad promedio de 74 años (rango 47-93) presentaron un rAAA y a 69 (65.2%) se les realizó la reparación a cielo abierto. 87 pacientes (82.9%) fueron sintomáticos y 25 (23.8%) tenían un AAA conocido. El tiempo medio transcurrido entre el diagnóstico y el tratamiento fue de 5 a 6 horas, 4.5 horas para la RA y de 8 horas para EVAR. El test rank log mostró una mejoría en la supervivencia con EVARa pesar del tiempo promedio más prolongado desde el diagnóstico al tratamiento. (p=0.02). Se administraron casi tres veces más concentrados de hematíes en el cohorte de reparación a cielo abierto (RA), 6.3 unidades y en EVAR 2.2 unidades. Se utilizaron vasopresores perioperatorios en el 57.1% de los casos, dos veces más en la RA, 69.6%, que con EVAR 33.3%. Se utilizó el balón oclusivo aórtico en el 27,6% de los casos, dos veces más frecuente en RA que en EVAR (41,7% verus 20,3%)...

Antecedentes: O propósito deste estudo é comparar a morbilidade e a mortalidade tanto da reparação aberta (RA) quanto endovascular, utilizadas no tratamento da ruptura do aneurisma aórtico abdominal (rAAAs); e de apresentar um algorítmo para o tratamento e avaliações da tomografiacomputarizada (CT) para assim determinar o uso de um balão para oclusão supra-celíaca. Métodos: Realizou-se uma revisão gráfica retrospectiva das rAAAs tratadas, seja com reparação a céu aberto (RA), ou com reparação aórtica endovascualar (EVAR) entre os meses de junho de1998 e junho de 2009. Informaram-se as comorbilidades, os dados periprocedimentos , além da morbidade e mortalidade. As TC foram revisadas desde o uso inicial do balão oclusivo (março de 2001) com o objetivo de avaliar o hematoma retroperitoneal. Desenvolveu-se um algorítmo para determinar quando o balão oclusivo deveria ser implementado. Para esta análise estatística, utilizaram-se o teste exato de Fisher, o t-test, e o test log Rank. Resultados: Entre junho de 1998 ejunho de 2009, 105 pacientes, 75 (71.4%) homens, com média de idade de 74 anos (média 47-93) apresentaram uma rAAA e em 69 (65.2%) realizou-se uma reparação a céu aberto. 87 pacientes (82.9%) foram sintomáticos e 25 (23.8%) tinham um AAA conhecido. O tempo médio transcorrido entre o diagnóstico e o tratamento foi de 5 a 6 horas, 4.5 horas para a RA e de 8 horas para aEVAR. O test rank log mostrou uma melhoria na sobrevivência com a EVAR, apesar do tempo médio mais prolongado do diagnóstico ao tratamento. (p=0.02). Administraram-se quase três vezes mais concentrados de hematies no grupo de reparação a céu aberto (RA), 6.3 unidades e no grupo EVAR, 2.2 unidades. Utilizaram-se vasopressores perioperatórios em 57.1% dos casos: 33.3% com EVAR e 69.6% com a RA, ou seja, duas vezes a mais. Utilizou-se o balão oclusivo aórtico em 27.6 % dos casos, duas vezes mais frequente nos casos da RA do que nos de EVAR (41.7 % versus 20.3%)...

Background: The purpose of this study is to compare morbidity and mortality of open and endovascular repair of ruptured abdominal aortic aneurysms (rAAAs); and present a treatment algorithm and assessment of computer tomography (CT) to determine usage of a supra-celiac occlusive balloon.Methods: Restrospective chart review was done of rAAAs treated with open (OR) or endovascular aortic repair (EVAR) between June 1998 and June 2009. Comorbidities, periprocedural data, and postoperative morbidity and mortality were recorded. CTs were reviewed from the initial use of the occlusive balloon (March 2001) to assess the retroperitoneal hematoma. An algorithm was developed determining when the occlusive balloon should be implemented. Fisher’s exact test, and log rank test were used for statistical analysis. Results: Between June 1998 and June 2009, 105 patients, 75 (71.4%) males, mean age of 74.0 years (range 47-93), presented with a rAAA and 69 (65.2%) received open repair. Eighty-seven patients(82.9%) were symptomatic and 25 (23.8%) had a known AAA. Mean time elapsed between diagnosis to treatment was 5.6 hours, 4.5 hours for OR and 8.0 hours for EVAR. Log rank test showsimproved survivability with the EVAR despite higher mean time from diagnosis to intervention (p=0.02). Nearly three times as much packed red blood cells were given in open repair cohort, O,6.3 units and EVAR, 2.2 units. Perioperative vasopressors were used in 57.1% of total cases, more than 2 times as often for O, 69.6%, and EVAR, 33.3%. Aortic occlusive balloon was used in 27.6% of cases, twice as often in EVAR (41.7% versus 20.3%)...

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.

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.

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.

Endovascular management of recurrent adult coarctation of the aorta.

Traditional open surgical repair has proven to be an effective treatment for the management of primary and recurrent coarctation of the thoracic aorta. Potential complications at short-term and long-term follow-up have included recurrent coarctation, hypertension, premature coronary artery disease, cerebrovascular disease, and anastomotic pseudoaneurysm. Endovascular repair of recurrent coarctation of the thoracic aorta offers a less invasive treatment approach in potential high-risk surgical patients.

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.

Is endovascular repair the new gold standard for primary adult coarctation?

OBJECTIVE: Primary adult aortic coarctation (PAAC) is an unusual cause of hypertension. The standard of care includes surgical repair, which can be associated with considerable morbidity and operative risk. Although balloon angioplasty has been successfully used in paediatric and adolescent patients with coarctation, little information exists regarding the endovascular repair of PAAC. This study examines the procedural safety and efficacy of endovascular repair of PAAC along with midterm outcomes. METHODS: Between January 2000 and July 2008, 16 patients underwent endovascular repair of PAAC. All patients were hypertensive with 13 patients (81.3%) receiving medical therapy. Symptoms included chest pain (n=11, 69%), progressive fatigue (n=5, 31%), exercise intolerance (n=4, 25%) and shortness of breath (n=3, 19%). Associated cardiac concerns included depressed ejection fraction (n=6, 38%), pulmonary hypertension (n=5, 31%), ascending aortic dilatation (n=5, 31%) and bicuspid aortic valve (n=4, 25%). Endovascular repair was achieved using a percutaneous femoral approach. Balloon angioplasty of the coarctation was performed prior to treatment using a balloon-expandable uncovered stent. Aortic diameters were assessed using intravascular ultrasound. Pre- and post-procedure pressure gradients were measured and success was determined as a residual pressure gradient across the treated aorta of less than 20 mmHg. RESULTS: The male:female (M:F) ratio was 9:7 with a mean age of 39.7 years. Procedural success was 100%. Mean pre-procedural aortic diameter was 8.4mm (3-14 mm) and mean post-procedural aortic diameter was 16.3mm (10-20mm) (p=0.04). The mean pre-procedural pressure gradient was 48.3 mmHg (25-100 mmHg) and the mean post-procedural pressure gradient was 0.5 mmHg (0-15 mmHg) (p=0.05). Twelve patients received one stent, two patients received two stents, one patient received three stents and one other patient received a thoracic stent graft. The rate of paraplegia was 0% with no blood transfusions, strokes or deaths. Follow-up ranged from 12 to 72 months (mean=22.8 months). One patient required re-intervention with an additional stent 14 months following the initial procedure and all the patients remain symptom-free. CONCLUSION: Endovascular repair of PAAC is safe and effective and compares favourably with open surgical repair. Midterm follow-up suggests that the treatment is durable and may be an alternative to surgical repair. Although this is the largest endovascular treatment series for PAAC reported to date, additional study and follow-up are needed.

Endovascular management of adult coarctation and its complications: intermediate results in a cohort of 22 patients.

OBJECTIVE: To determine the safety and effectiveness of current endovascular treatment in adult patients with thoracic aortic coarctation and its complications. METHODS: A cohort of 22 patients was treated for late presenting primary or recurrent coarctation or aneurysmal formation at varying intervals following childhood intervention. RESULTS: Ten patients with recently discovered de novo coarctations were treated with balloon-expandable stents, and an endoluminal graft (ELG) was used in one additional patient. In the other 11 patients with recurrent lesions, three underwent repeat balloon dilation and stenting; eight patients with recurrence with aneurysms received ELGs. The gradients across the coarctation decreased from 49 + 16 to 4 + 7 mmHg (p = 0.001), and the diameters increased from 10 + 4 to 19 + 4mm (p = 0.001). In five of the eight patients (63%) with aneurysms, the ELG covered the subclavian artery, and a carotid subclavian bypass was necessary. Two patients required iliac artery access. No early major complications occurred. At mean follow-up of 31 + 15.6 months, one patient with type II leak resolved spontaneously and another developed neck dilation and type I leak, requiring a second ELG placement. All patients except one had improvements in symptoms and better hypertension control. CONCLUSIONS: We conclude that primary or secondary endovascular intervention in adults with de novo or recurrent coarctation and aneurysms is feasible with good intermediate results.

Inferior mesenteric artery stenting: a solution for chronic mesenteric ischemia.

Chronic mesenteric ischemia (CMI) is a rare entity with potentially tragic consequences. Meanwhile, there is still no consensus regarding the most adequate treatment approach. The authors herein report a case of a 65-year-old woman with severe CMI as a result of an occlusion of both the celiac artery (CA) and superior mesenteric artery (SMA) and a significant stenosis of the inferior mesenteric artery (IMA) ostium. The patient was successfully treated by angioplasty and stenting of the IMA. Even though the usual approach for CMI is revascularization of the CA and the SMA, the present case demonstrates that IMA can have a central role in visceral circulation, and its endovascular revascularization can be the first treatment option in selected cases.

Identifying paraplegia risk associated with thoracic endografting.

Endografting, like open surgical repair of the thoracic aorta, can be complicated by paraplegia. We reviewed our thoracic endografting experience regarding the incidence and treatment of spinal cord neurologic events. Between February 2000 and July 2008, 346 patients underwent endoluminal grafting of the descending thoracic aorta. Indications for intervention included atherosclerotic aneurysms (45.9%), acute and chronic dissections (31.5%), miscellaneous lesions (13.6%), and penetrating aortic ulcers (8.9%). Ten women and 4 men (4.0%), with a mean age of 71.3 years, developed either paraparesis (1.7%) or paraplegia (2.3%). Nine (64.3%) of these patients had an aneurysm, 4 (28.6%) had acute or chronic type B aortic dissection, and 1 (7.1%) had a penetrating aortic ulcer; 3 (21.4%) of them had previously undergone open abdominal aortic aneurysm repair, and 13 (92.9%) required coverage of more than 20 cm of the aorta. Cerebrospinal fluid drainage was instituted in 7/8 paraplegic patients. Eight (57.1%) of the 14 patients recovered fully, 2 (14.3%) experienced partial recovery, and 4 (28.6%) had significant neurological deficits. Paraplegia following thoracic endografting appears to be associated with female sex, long-segment coverage of the thoracic aorta, and aneurysmal disease.

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.

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.

Endovascular repair in the thoracic and abdominal aorta: no increased risk of spinal cord ischemia when both territories are treated.

PURPOSE: To evaluate the morbidity associated with thoracic and abdominal aortic repair using endovascular exclusion alone or combined endovascular and open repair. METHODS: Between January 1998 and February 2007, 49 patients (36 men; mean age 70 years) underwent treatment for thoracic and abdominal aorta disease with descending thoracic aortic (DTA) stent-graft and abdominal aortic repair. Thirty-nine patients with coexisting thoracic and abdominal pathologies were classified with multilevel aortic disease (MLAD), whereas 10 patients presented with thoracoabdominal aneurysm. Patients were separated into 3 groups: 1: thoracic stent-grafts and open abdominal repair (n = 18), group 2: thoracic and abdominal stent-grafts (n = 21), and group 3: thoracic stent-grafts with visceral artery debranching (n = 10). Prior carotid-subclavian bypass was performed in 3 (6%) patients with a dominant left vertebral artery. RESULTS: Stent-graft deployment was technically successful in all cases. Eight (16%) patients underwent emergent thoracic stent-graft placement. In 9 (18%) patients, the left subclavian artery was covered. No incidence of spinal cord ischemia was observed. The 30-day mortality was 4%, and overall mortality was 6% over a mean 33-month follow-up. The endoleak rate was 6% (1 type I, 1 type II, and 1 type III). CONCLUSION: Conventional or endovascular abdominal open repair in combination with DTA stent-grafting is feasible and a safe alternative to traditional open repair. Management of MLAD did not show increased incidence of spinal cord ischemia and was associated with fewer complications and deaths than simultaneous or staged open thoracic and abdominal repairs.