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Purpose: To report early clinical experience with virtual histology intravascular ultrasound (VH IVUS) in carotid endoluminal repair. Technique: A 2.9-F, 20-MHz catheter that utilizes computer software to demonstrate the histological components of arteriosclerotic plaque was evaluated during carotid angioplasty and stenting. VH IVUS images were created following a pullback through the carotid stenosis and produced a color-coded map of the different histological constituents of the disease (dark green: fibrous, yellow/green: fibrofatty, white: calcified, and red: necrotic lipid core plaque). Conclusion: VH IVUS produces a color-coded map of the different histological components of artery plaque. It has the potential to predict how the plaque is likely to behave at the moment of endoluminal treatment. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the effectiveness of endovenous treatment of symptomatic varicose veins using the endovenous laser (EVL) or radiofrequency (RF) energy over a >3-year follow-up. Methods: From February 2002 to August 2005, 981 consecutive patients (770 women; mean age 51 years, range 15-90) with symptomatic varicose veins in 1250 lower limbs underwent endovenous ablation of 1149 great saphenous veins (GSV) and 101 small saphenous veins (SSV) under tumescent anesthesia without intravenous sedation or regional anesthesia. There were 990 GSV and 101 SSV procedures using EVL; 159 GSVs were treated with RF energy. An ultrasound evaluation was performed within 2 weeks of the procedure to evaluate occlusion of the vein, wall thickness, and clot extension into the deep venous system. Follow-up from the first 200 procedures in the series included clinical evaluation and duplex ultrasound scanning at 6 and 12 months and annually thereafter. Results: Of the 1149 GSVs treated, 39 (3.4%) recanalizations were seen in 33 of the EVL and 6 of the RF procedures for inadequate treatment as judged by ultrasound. There were 9 (9.0%) failures among the 101 SSVs treated with EVL. Overall, both EVL and RF procedures were well tolerated, with only minor complications. One obese patient with ulcer developed pulmonary embolus on the fourth postoperative day. There were no differences between EVL and RF in efficacy or complications. Follow-up at a mean 3 years (range 30- 42 months) in 143 treated limbs showed no neovascularization in the groin. Conclusion: Outcomes with EVL and RF were good, with low complication rates that may be related to the use of local tumescent anesthesia without intravenous sedation. [ABSTRACT FROM AUTHOR]

Background: Thoracic aortic dissections, ruptures, fistulae, and aneurysms pose a unique surgical challenge. Traditional repair of thoracic aortic aneurysms involves thoracotomy with graft interposition. Despite advances in perioperative care and both total and partial cardiopulmonary bypass, conventional surgery carries a significant morbidity and mortality. Principal complications include bleeding, paraplegia, stroke, cardiac events, pulmonary insufficiency, and renal failure. Recent enthusiasm for innovative endovascular therapies to treat aortic disease has spurred many centers to investigate endoluminal grafting of the thoracic aorta. Early reports on endovascular repair using custom made "first generation devices" demonstrated the technique to be feasible with a mortality and morbidity comparable to open repair.Methods and Results: From February 2000 to February 2001, endovascular stent graft repair of the thoracic aorta was performed in 46 patients (mean age 70; 29 male and 17 female) using the Gore Excluder. Twenty-three patients (50%) had atherosclerotic aneurysms, fourteen patients (30%) had dissections, three patients (7%) had aortobronochial fistulas, three patients (7%) had pseudoaneurysms, two patients (4%) had traumatic ruptures, and one patient (2%) had a ruptured aortic ulcer. Patient characteristics, procedural variables, outcomes, and complications were recorded. All patients were followed with chest CT scans at 1, 3, 6, and 12 months. Mean follow up was 9 months ranging from 1 to 15 months. All procedures were technically successful. There were no conversions. Average duration of the procedure was 120 minutes. Average length of stay was 6 days, but most patients left the hospital within 4 days (64%) after endoluminal grafting. Overall morbidity was 23%. Two patients (4%) had endoleaks that required a second procedure for successful repair. Two patients (4%) died in the immediate postoperative period. There were no cases of paraplegia. At follow-up, one patient had an endoleak found the day after the procedure and another patient had an endoleak 6 moths post procedure. Both were treated successfully with additional stent grafts. There were no cases of migration. One patient died of a myocardial infarction 6 months after graft placement. The Gore Excluder device was voluntarily recalled on February 26, 2001. Therefore, from June 2000 to January 2001, 37 patients underwent endovascular stent graft repair of the thoracic aorta for various disease entities using our customized thoracic graft (Endomed). Twenty-seven patients (73%) had aneurysms, six (16%) had dissections, two (5%) had pseudoaneurysms, one (2%) had a traumatic transection, and one patient (2%) had an embolizing ulcer. Patients were followed with CT scans at 1, 3, 6, and 12 months. All procedures were technically successful. There were no conversions. The average age was 68 years.(17-87). And the male and female ratio was 24/13. One patient died in the operating room from iliac rupture and one died from embolization/stroke in the immediate postoperative period. Two patients died within 30 days from comorbid factors. The total 30-day mortality was 10%. Two patients had endoleaks. One returned to the operating room and needed an additional cuff. The other had a small leak in a proximal dissection that is being followed. There were no cases of paraplegia.Conclusion: Thoracic endoluminal grafting is a safe and feasible alternative to open graft repair and can be performed successfully with good results. Early data suggest that an endoluminal approach to these disease entities maybe favorable to open resection and graft replacement. Technical details of Endoluminal stent grafting of the thoracic aorta for different disease entities have been discussed at length. [ABSTRACT FROM AUTHOR]

Advances in endoluminal technology have enabled interventionists to treat a variety of pathologies that traditionally would require open surgery. Although excluding descending thoracic aortic aneurysms seems feasible, thoracic aortic dissection and its complications are an area in which the appropriateness of endovascular therapy has yet to be defined. Five case reports are presented, each with varying pathologies associated with type III dissections. The follow-up of the cases ranged from 6 to 18 months with a mean of 12.2 months. The endovascular approach and the technical aspect of the intervention have been emphasized in each case. [ABSTRACT FROM AUTHOR]

When donor hearts are studied systematically after transplantation, by programmed electrical stimulation, sinus node dysfunction has been found to be common though data regarding symptoms related to this phenomenon are not available. In this case report we describe a heart transplant recipient who experienced serious symptomatic sinus node dysfunction associated with transient atrial fibrillation 17 days after cardiac transplantation; there was no evidence of donor heart rejection. Intracardiac electrophysiology testing confirmed sinus node dysfunction of the donor heart, but only with relatively rapid atrial pacing rates. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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., (© The Author(s) 2016.)

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.

Objective/background: To investigate experimentally the arterial wall/device compliance mismatch of four stent-graft devices and a multilayer flow modulator within the supra- and infrarenal locations for the treatment of abdominal aortic aneurysms (AAA)., Methods: Five devices (MFM, EndurantII, Excluder, Zenith, and Fortron) were tested under physiological flow conditions within a flow simulator system comprising of a patient-specific thin-walled flexible AAA perfusion model with replicated intraluminal thrombus, supported by the spinal column. Devices were submitted to circumferential force tests and implanted in the perfusion model for circumferential arterial pressure/diameter measurements. Parameters, including radial resistive force, supra-/infrarenal compliance, pulsatile arterial energy loss (PAEL), pulse wave velocity (PWV), and wave reflection coefficient (Γ), were computed to characterise the devices' performance., Results: The Zenith and EndurantII devices had the highest radial resistive force (up to 3 N/cm), while the Fortron device had the lowest (0.11 N/cm). Supra- and infrarenal compliance varied between 6.9-5.1 × 10(-4)/mmHg and 4.8-5.4 × 10(-4)/mmHg, respectively. Two devices (EndurantII and Excluder) significantly decreased infrarenal compliance by 13-26% (p < .001). Four devices increased the PAEL by 13-44% (p < .006). The PWV ranged from 10.9 m/s (MFM; p = .164) to 15.1 m/s (EndurantII; p < .001). There was an increase of 8-238% (p < .001) in the reflection coefficient for all devices., Conclusion: Commercially available endovascular devices lower the aortic wall compliance after implantation. The MFM was found to be the most compliant in the suprarenal region, while the Fortron device was the most compliant in the infrarenal region. Choosing the most compliant devices for treating AAAs produces positive gains in the aortic elastic recoil, thus minimising the device related complications., (Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.)

A major ongoing challenge for the endograft industry has been to create an endograft that assures the same reliable aneurysm seal afforded by surgical resection and suturing of a prosthetic graft to the abdominal aortic wall. The focus of these developmental efforts has always been the proximal neck, where the endo-graft must be firmly affixed to the aorta to prevent device movement and seal against leakage. The two mechanisms of fixation and seal, however, apply to both the proximal and the distal landing zones. Today's bifurcated stent-graft is configured much as it was two decades ago, with a short main body and long limbs, one of which must be mated to the main body after its deployment. The unibody Powerlink endograft made by Endologix, with its long main body and two innate limbs, is deployed so that it rests on the native aortoiliac bifurcation, the first and still only bifurcated endograft design to use anatomical fixation for stabilization and separate seal from fixation. The original Powerlink stent-graft has several design features that have allowed engineers to evolve new sealing technology that is featured on the company's latest iteration, the AFX Endovascular AAA System. This article reviews the approaches taken to enhance the device's ability to reduce type I endoleaks and provides some insight into the challenges of creating the perfect seal for an aortic stent-graft.

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.

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., (Copyright © 2012. Published by Elsevier Inc.)

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., (Published by Mosby, Inc.)

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., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

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., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

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.

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., (Copyright © 2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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., (Copyright 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.)

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., (Published by Mosby, Inc.)

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., (Copyright 2009 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.)

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.

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.

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.

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.

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.

Coronary artery bypass grafting (CABG) remains the most common procedure performed by cardiac surgeons, yet it is clear that the landscape of coronary intervention is constantly changing as new technology is introduced and data from countless studies continues to be published. However, no single study will be able to clearly define the indications for surgical versus percutaneous revascularization in every clinical scenario given the complexity of this disease as well as that of the patients it afflicts. Moreover, the significant improvements in percutaneous therapy, medical therapy management, perioperative care and secondary prevention after revascularization have decreased the morbidity and mortality of coronary artery disease making comparison between therapies far more difficult. Based on the available literature to date, surgical revascularization (CABG) provides significant benefit in certain patient populations; particularly those with comorbid conditions (for example diabetes, left ventricular [LV] dysfunction) and with more severe disease (for example left main, three-vessel). The goal of this article is to outline the current for surgical revascularization (CABG) understanding that coronary artery disease will continue be an important cause of morbidity and mortality and further study and re-evaluation of these recommendations will likely be necessary as time goes on.

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.

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.

Thoracic aortic endografting is proving to be extremely useful for correcting a variety of lesions with few complications, and several devices have recently been approved by the Food and Drug Administration (FDA). Endovascular intervention avoids sternotomy or thoracotomy, chest tubes, respirators, general anesthesia, and blood loss is limited. 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. There is no Level-1 evidence of endografting's efficacy in the thoracic aorta, and the pathologies encountered in this vascular territory are complex and often associated with other injuries or lesions, making randomized comparisons between open and endovascular procedures virtually impossible. Nevertheless, series results from centers of excellence indicate thoracic aortic endografting in patients with favorable anatomy and pathology for a specific device yields excellent results. Thoracic aortic endografting is an important alternative to open repair and will likely become the preferred treatment modality as additional devices become available and more experience is achieved in this vascular region.

Objective: Increasing experience with thoracic aortic stent grafts has led to a more aggressive approach to thoracic aortic pathologies in the distal aortic arch and proximal descending thoracic aorta. To increase the length of the proximal landing zone, it is sometimes necessary to cover the left subclavian artery with the thoracic stent-graft, introducing the risk of retrograde filling of the excluded aorta from the left subclavian artery. It is currently unclear how best to manage these patients to prevent persistent risk of aneurysm expansion or rupture. We report our experience with a minimally invasive endovascular repair of the covered left subclavian artery., Methods: We reviewed prospectively gathered data on all investigational device exemption-approved patients undergoing thoracic aortic stent grafting at the Arizona Heart Institute from 2000 to 2006 (n = 289 patients). Patients had surveillance with a contrast-enhanced computed tomography scan on the first postoperative day and during follow-up at 1, 6, and 12 months., Results: A total of 289 patients received thoracic stent grafts during the study: Medtronic Talent (Medtronic, Minneapolis, Minn) (n = 25) or Gore TAG (WL Gore & Associates Inc, Flagstaff, Ariz) (n = 261). The left subclavian artery was covered in 23% of patients (n = 66), of whom 17% had preoperative carotid-subclavian bypass (n = 11/66). Among patients with left subclavian artery coverage, the 30-day mortality was 6.1% (n = 4), procedure-related strokes developed in 3 patients (n = 3, 4.6%), and the incidence of left arm claudication was 7.6% (n = 5), necessitating postoperative carotid-subclavian bypass in 2 patients. Twelve patients (18%) had a type I (n = 6) or II (n = 7) endoleak. Coverage of the left subclavian artery accounted for 71% of the type II endoleaks (n = 5), whereas patent intercostals accounted for the rest (n = 2). Type II endoleaks associated with left subclavian artery coverage were successfully treated by retrograde coil embolization from the left brachial artery (n = 3) or left subclavian artery ligation (n = 1)., Conclusion: Coverage of the left subclavian artery during thoracic aortic stent grafting is associated with a low incidence of arm complications and type II endoleaks. All type II endoleaks were successfully treated by retrograde coil embolization or ligation of the left subclavian artery. Successful treatment of endoleaks may reduce the risk of aneurysm expansion or rupture.

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.

Intravascular ultrasound is a novel endovascular imaging technology that is useful as an imaging tool for diagnosis and treatment of arterial and venous pathologies. Intravascular ultrasound is particularly useful as a decision-making tool in the endovascular management of vascular pathologies. Recently the aorta has become increasingly amenable to endovascular technology, and with the advent of intravascular ultrasound detailed imaging, using intravascular ultrasound permits the diagnosis and endovascular management of various complex aortic pathologies affecting the abdominal and thoracic aorta. Various aortic pathologies including thoracic and abdominal aortic aneurysms, type B dissections, penetrating aortic ulcers, coarctation of the aorta, and many other aortic pathologies, which were once only amenable by open surgical repair are increasingly being managed with endoluminal technology. As experience develops with this technology, more complex aortic pathologies would become readily amenable to advanced endovascular interventions.

Background: To evaluate the feasibility and safety of thoracic endografting in the octogenarian population., Methods: Between February 2000 and August 2005, 249 patients with a mean age of 69+/-12.3 years (range 23-91) underwent thoracic endografting. Forty-four patients (27 males and 17 females) were octogenarians with a mean age of 84+/-2.7 years. Indications for intervention included: atherosclerotic aneurysms (26/44, 59%), acute and chronic dissections (9/44, 20.5%), penetrating aortic ulcers (6/44, 14%) and contained rupture (3/44, 7%)., Results: Endovascular repair was achieved in all octogenarian patients (44/44, 100%). Mean length of stay was 4.7+/-3.6 days. Two cardiac-related deaths and 1 retrograde dissection death occurred (3/44, 7%). Complications included hemiparesis (n=2) with full recovery at discharge, groin hematoma (n=1), pneumonia (n=2) and stroke (n=1) [6/44, 11%]. Endoleaks were diagnosed in 3 patients [3/44, 7%] (2 type I, 1 type II) at 30-day follow-up. Two patients developed an endoleak beyond 30 days [2/44, 5%] (1 type I, 1 type II). Two re-interventions were necessary at 30 days (1 type I, 1 type II). Mean follow-up was 22 months and there were no device migrations or aortic ruptures. No statistical differences in overall mortality were noted between octogenarians and non-octogenarians at 30 days (7% vs 6%, p=NS), 12 months (18% vs 13%, p=NS) and 24 months (27% vs 15%, p=NS). However, at 5 years post-procedure, octogenarians had a significantly higher overall mortality than non-octogenarians (32% vs 17%, p=0.038)., Conclusions: Advanced age is not a contraindication to thoracic endografting with favorable short and mid-term outcomes compared to non-octogenarians.

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.

Objective: Endoluminal grafting is emerging as a less invasive alternative to the treatment of descending thoracic aorta diseases. Endoleaks (continued pressurization of the treated aorta external to the endoluminal graft) are a potential complication. We reviewed our cumulative endovascular experience for descending thoracic aorta pathologies with respect to the management of endoleaks and associated patient outcomes., Methods: As part of a single-site investigational device-exemption protocol, 249 patients (146 men, 103 women) with thoracic aortic diseases underwent attempted delivery of a TAG endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz) between February 2000 and August 2005. Indications for study enrollment included 111 atherosclerotic aneurysms (44.6%), 67 aortic dissections (26.9%), 27 penetrating aortic ulcers (10.8%), 14 contained ruptures (5.6%), 11 pseudoaneurysms (4.4%), 9 acute aortic transections (3.6%), 7 aortobronchial fistulas (2.8%), 2 endoleaks (0.8%) after prior thoracic endoluminal grafting, and 1 (0.4%) adult coarctation. Endoleak surveillance was performed using serial computed tomography scans., Results: Mean patient age was 68 years (range, 23-91 years). Endoleak developed in 38 patients (15.3%): 15 distal type I (39.5%), 13 proximal type I (34.2%), 8 type II (21.1%) and 2 type III (5.3%). No surgical intervention was performed in 26 patients (68.4%), in which the endoleak spontaneously resolved in 14 (53.8%), 8 (30.8%) are being monitored and are asymptomatic, 3 (11.5%) died of unrelated causes, 2 (7.7%) withdrew from the study, and 1 (3.8%) was lost to follow-up. Twelve patients (31.6%) required reintervention using an additional endoluminal graft: 8 (66.7%) with a proximal type I endoleak, 2 (16.7%) with a distal type I endoleak, 1 (8.3%) with both distal type I and type III endoleaks, and 1 (8.3%) with a type III endoleak. Open conversions were necessary secondary to device deployment difficulties in two patients (0.8%), and due to expansion of a thoracoabdominal aneurysm and rupture of an aneurysm secondary to a type II endoleak in one patient (0.5%) each., Conclusion: Endoleaks are an infrequent, yet important, complication after thoracic endografting. Many endoleaks will resolve spontaneously, but some patients may require another endovascular intervention. Close surveillance is recommended for these patients; however, open conversion is rarely indicated. Because more diseases of the thoracic aorta are being treated using an endovascular approach, a standardized treatment algorithm is essential to safely and effectively manage associated endoleaks.