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Papers by Ross Milner
Journal of Vascular Surgery, 2014
the number of TAAA cases performed nationally and a decline in the rate of ruptured TAAA (P < .00... more the number of TAAA cases performed nationally and a decline in the rate of ruptured TAAA (P < .001). Conclusions: A decline in the number of TAAA cases was observed over the study period; however, the costs associated with treatment increased significantly. The overall in-hospital mortality is decreasing for TAAAs. A sharp rise in the use of endovascular techniques for the management of TAAA was seen over the study period. The overall mortality of TEVAR was significantly lower compared with OAR.
Figure 1. Computed tomography of small, calcified external iliac arteries.
European Journal of Vascular and Endovascular Surgery, 2019
iliac navigation without iliac complications, successful endograft deployment, renal and hypogast... more iliac navigation without iliac complications, successful endograft deployment, renal and hypogastric arteries patency at the end of the procedure, no evidence of type I-III endoleak at the end of the procedure, no conversion to open repair-OR, no intra-operative mortality), 30-days iliac arteries complications rate, 30-days endoleak rate and 30days mortality. Secondary end-points were: short-term endograft related re-intervention, iliac leg occlusion and AAA-related mortality. Both primary and secondary endpoints were evaluated for the whole sample and in patients whit (Group A) and without (Group B) hostile iliac anatomy (angle/tortuosity, diameter and calcifications). Iliac hostility was defined following Chaikof's classification 1. Univariate and multivariate analysis was performed using Chi-squared and Fischer Exact test. Results-During the enrollment period, 274 patients (male 91.6%;mean age 75.7;ASA 3/4, 66,4%/24,2%) were treated using Cook Zenith Alpha Abdominal Endograft for elective EVAR in 14 centres. TS was 98,5%. No intra operative mortality and immediate conversion to OR occurred. Thirtydays endograft-related reintervention, iliac leg occlusion, iliac leg complication and mortality rate were respectively 0,3% (1 case of type 1A endoleak treated with surgical conversion), 0%, 0% and 1,7% (non-procedure related 1,4%; procedure-related 0,3%). Two hundred sixty-two patients (95,6%) presented with accurate morphological data; 60 (22,9%) had at least one morphological aspect of iliac hostility. Univariate and multivariate analysis didn't show significant differences between Group A and B for any of primary and secondary end-points. Mean follow up was 4.96 months (0-14,3; SD 3,9). Survival rate was 96,7% with a AAA-related mortality, rupture, iliac leg occlusion and endograft related reintervention rate of 0%, 0%, 1,6% and 2,4% respectively. Iliac hostility didn't affect the short-term results. Conclusion-Our preliminary results suggest Cook Zenith Alpha Abdominal Endograft to be a safe and effective tool for EVAR in abdominal aortic aneurysms with severe iliac anatomy. References 1 Chaikof EL, Fillinger MF, Matsumura JS, Rutherford RB, White GH, Blankensteijn JD et al. Identifying and grading factors that modify the outcome of endovascular aortic aneurysm repair.
EJVES Vascular Forum, 2020
Introduction: This report presents the treatment of an aortic endovascular aneurysm repair (EVAR)... more Introduction: This report presents the treatment of an aortic endovascular aneurysm repair (EVAR) device failure, focusing on the use of colour duplex ultrasound (CDUS) to diagnose and confirm effective treatment of a type IIIb endoleak. Report: An 89 year old man with a history of EVAR was transferred to the authors' centre with complaints of abdominal pain and a pressure sensation behind the umbilicus. A previously stable 11 cm aneurysm sac was visualised on computed tomography angiography in addition to a newly suspected type IIIb endoleak, which was confirmed via CDUS. He underwent successful endovascular repair with a stent across the limb defect. The patient was discharged uneventfully and was followed for surveillance. Discussion: Type IIIb endoleak is an underreported complication after EVAR. CDUS of type IIIb endoleak aided in localisation and characterisation of the graft failure, and confirmed successful endovascular treatment of the endoleak defect in the side limb. Locating the point of graft failure using CDUS preceding endovascular repair of type IIIb endoleaks guides interventions and repair outcomes. It is a rare opportunity to report a case of acute type IIIb endoleak with CDUS that definitively localised an endograft defect.
Journal of Vascular Surgery, 2019
We have previously shown that patients with abdominal aortic aneurysm (AAA) have decreased number... more We have previously shown that patients with abdominal aortic aneurysm (AAA) have decreased number and diminished immune suppressive function of regulatory type 1 T cells (Tr1) and increased numbers of activated effector Th17 cells. The objective of this clinical trial was to assess the efficacy of allogeneic mesenchymal stem cells (MSCs) in inducing Tr1 cells and suppressing AAA inflammation. Methods: The AneuRysm Repression with mEsenchymal STem cells (ARREST) trial is a blinded, placebo-controlled phase 1 study in which patients with small AAA (30-to 50-mm diameter) are randomized to intravenous infusion of placebo (plasmalyte A), 1 million MSCs/kg, and 3 million MSCs/kg (n ¼ 12/group). Blood samples are collected at baseline and at days 3, 7, 14, 28, and 60 and yearly. The primary end point is change in the ratio of Tr1:Th17 cells at 14 days after treatment using flow cytometry. Secondary end points are changes in FoxP3 + T-regulatory cells, myeloid-derived suppressor cells, microRNA profiles, serum cytokine levels, changes in AAA inflammation as measured by 18-fluorodeoxyglucose positron emission tomography/computed tomography, and changes in aneurysm diameter and volume at years 1 to 5. Results: Twenty-one patients have been enrolled to date. There have been no treatment-related adverse events, and one patient withdrew after discovery of an occult pulmonary malignant neoplasm on baseline positron emission tomography/computed tomography. At day 14, the ratio of Tr1:Th17 cells increased by 20.3 6 1.3-fold from baseline for the highdose MSC group (n ¼ 7) compared with 4.3 6-fold for the low-dose group (n ¼ 7; P < .01) and À10 .66 2.3-fold for the placebo group (n ¼ 7; P ¼ .001; Fig). There was a decrease in 18-fluorodeoxyglucose uptake as measured by standard uptake values by 5.6% 61.3% in the combined MSC group (n ¼ 7) compared with an increase in standard uptake values of 4.1% 6 1.0% in the placebo group (n ¼ 4; P < .05). Although the sample size was too small for statistical comparison, the average increase in maximal transverse diameter of AAA at 12 months after treatment was À1.6 6 0.6 mm in the combined MSC group (n ¼ 4) and 4.3 6 0.9 mm in the placebo group. Conclusions: The results of the ARREST trial demonstrate a significant increase in Tr1 cells concurrent with a decrease in cytotoxic effector Th17 cells in an MSC dose-dependent fashion, achieving the primary end point. Preliminary data suggest that aneurysm inflammation and expansion are decreased with MSC treatment.
Journal of Vascular Surgery, 2011
artery localization, and completion angiography were done with CO 2 in all patients, including hy... more artery localization, and completion angiography were done with CO 2 in all patients, including hypogastric embolization in 26 cases. Preoperative national kidney foundation (NKF) glomerular filtration rate (GFR) classification was: normal in 16 patients, mildly decreased in 52, moderate to severely decreased in 44, and 2 were in renal failure. Results: All grafts were successfully deployed with no conversions. CO 2 angiography identified 20 endoleaks (2 type 1, 16 type 2 and 2 type 4) and 3 unintentionally covered arteries. Additional use of IC in 42 patients did not modify the procedure in any case. When compared with a cohort of 50 consecutive patients who underwent EVAR done exclusively with IC, the operative time was shorter with CO2 (177 vs 194 min; P ϭ .01); fluoroscopy time was less (21 vs 28 min; P ϭ .002), and volume of iodinated contrast was lower (37 vs 106 mLs; P Ͻ .001). Postoperatively, there was one death, one instance of renal failure, and no complications related to CO 2 use. Patients with moderate to severely decreased GFR undergoing EVAR with IC had a 12.7% greater (P ϭ .004) decrease in GFR compared with the CO 2 EVAR group. At one, six and 12 month follow-up, CTAs showed well positioned endografts with the expected patent renal and hypogastric arteries in all patients, and no difference in endoleak detection compared with the iodinated contrast EVAR group. During follow-up, 8 transluminal interventions and one open conversion were required, but no aneurysm related deaths occurred. Conclusions: CO 2 guided EVAR is technically feasible and safe, it eliminates or reduces the need for iodinated contrast use, may expedite the procedure, and avoids deterioration in renal function in patients with pre-existing renal insufficiency. A prospective trial comparing CO 2 with iodinated contrast during EVAR is warranted.
Journal of Vascular Surgery, 2011
Objectives: This study assessed the safety and efficacy of thoracic endovascular aortic repair (T... more Objectives: This study assessed the safety and efficacy of thoracic endovascular aortic repair (TEVAR) in the management of aortobronchial fistulas. Methods: A retrospective review was performed at Emory University Hospital to identify all patients who presented with an aortobronchial fistula. The diagnosis was based on clinical, radiologic, and bronchoscopic findings. Patients who underwent TEVAR as definitive management of these fistulas were identified. Demographics, history of thoracic aorta pathology or intervention, type and number of endografts used, need for reoperation, and clinical and radiologic follow-up data were collected for each individual. Results: Between 2000 and 2009, 11 patients received TEVAR as definitive management of aortobronchial fistulas. Technical success was achieved in 10 patients (91%). Six patients (55%) had previously undergone thoracic aortic surgery. A proximal type 1 endoleak developed in one patient after graft deployment and required reintervention for additional graft placement. No intraoperative or 30-day deaths occurred. Postoperative clinical and radiographic assessment was a mean of 8.8 months (range, 1-40 months). For all 10 patients in whom technical success was achieved at the initial operation, no endoleaks were noted at the follow-up CT scan. In addition, no patient required a further intervention. Conclusions: This study represents the largest reported series on the use of TEVAR in the management of aortobronchial fistulas. Supported by postoperative surveillance imaging and clinical evaluation, TEVAR has proven to be a safe and effective management strategy for an otherwise lethal condition. Long-term follow-up data are needed to ascertain the durability of this approach.
Journal of Vascular Surgery, 2005
Objective: Reports continue to document the occurrence of major adverse events after endovascular... more Objective: Reports continue to document the occurrence of major adverse events after endovascular aortic aneurysm repair. Although many of these problems can be successfully managed through endovascular salvage, operative conversion with explantation of the endoprosthesis remains necessary in some patients. We report herein a review of all patients initially enrolled in multicenter US clinical trials of the Excluder endograft who underwent secondary conversion to open surgical repair. Methods: Clinical data and relevant medical records of patients enrolled in phase I and II multicenter US clinical trials of the Excluder endograft were retrospectively reviewed for adverse events and further narrowed to those patients who underwent secondary operative conversion. Hospital records, operative and anesthesia reports, and all imaging studies were analyzed at initial implantation and at the time of subsequent open surgical repair. Results: Late open conversion was performed in 16 (2.7%) of the 594 patients enrolled in the Excluder clinical trials. Presumed endotension accounted for 8 of 16 of secondary conversions. In two of these patients, however, an endoleak was identified at the time of open surgical repair. Of the remaining eight patients, two underwent conversion for device infection, five for persistent endoleak, and one for aneurysm rupture. The overall 30-day mortality was 6.25% (1/16), with one death occurring in a patient with a ruptured aneurysm. Of patients who underwent conversion because of endotension, the maximal abdominal aortic aneurysm diameter (mean ؎ SD) at the time of initial implantation and subsequent graft removal was 61 ؎ 11 mm and 70 ؎ 10 mm, respectively. The mean time to open conversion for treatment of endotension was 37 ؎ 12 months (range, 20-50 months; median, 42 months). Freedom from conversion was 98.6% and 96.7% at 24 and 48 months, respectively. Conclusions: Endotension in the absence of a demonstrable endoleak has been a major indication for late surgical conversion in patients treated with the Excluder endograft. Given the potential presence of an undetected endoleak and the possible effects of progressive sac enlargement on long-term device stability, continued close surveillance of patients with assumed endotension is required. Should changes in device design eliminate endotension, a further reduction in the already low incidence of late open conversion of the Excluder endograft can be anticipated.
Journal of Vascular Surgery, 2010
Objective: This study evaluated the durability of adjunctive endovascular neck procedures, includ... more Objective: This study evaluated the durability of adjunctive endovascular neck procedures, including aortic cuffs, Palmaz stents (Cordis, Miami Lakes, Fla), and high-pressure balloon angioplasty, at managing intraoperative proximal neck complications during endovascular aortic aneurysm repair (EVAR). Methods: This was a single-center retrospective review of EVARs. The primary outcome variable studied was survival free of a graft-related event (GRE). GRE was defined by the occurrence of one of the following: type I endoleak, sac enlargement, aneurysm rupture, death, or procedure related to the aortic neck. These outcome variables were assessed relative to the preoperative anatomic neck variables (neck length, diameter, degree of angulation, degree of circumferential thrombus, and presence of conicity), procedural variables (manufacturing type of graft, use of a Palmaz stent), and patient characteristics (age and presence of medical comorbidities). Outcomes were assessed by t tests, Pearson 2 , and Kaplan-Meier analysis, when appropriate. Results: A total of 174 EVARs performed between January 2005 and December 2007 were evaluated. Fifty-six adjunctive procedures were performed, with a 97% primary-assisted exclusion rate. Patients who received an adjunctive therapy had similar freedom from a GRE compared with EVARs that did not require adjunctive therapy (35.5 ؎ 2.6 vs 34.8 ؎ 1.5 months, P ؍ .31, log-rank test). Subset analysis identified a significant association between Palmaz stent placement at the time of EVAR and decreased freedom from GREs (hazard ratio, 2.87; 95% confidence interval, 1.21-6.77; P ؍ .02). Conclusions: Midterm results suggest that adjunctive therapies to manage intraoperative proximal neck complications do not compromise durability. The subset of patients requiring aortic neck Palmaz stent placement at the time of EVAR are among those at highest risk for subsequent GRE.
Journal of Vascular Surgery, 2012
Endovascular treatment of superficial femoral artery (SFA) lesions is a well-established practice... more Endovascular treatment of superficial femoral artery (SFA) lesions is a well-established practice. The repercussions of failed SFA interventions are unclear. Our goal was to review the efficacy of SFA stenting and define negative effects of its failure. Methods: A retrospective chart review was conducted from January 2007 to January 2010 that identified 42 limbs in 39 patients that underwent SFA stenting. Follow-up ankle-brachial index and a duplex ultrasound scan was performed at routine intervals. Results: Mean patient age was 68 years (range, 43-88 years); there were 22 men (56%) and 17 women (44%). Intervention indication was claudication in 15 patients (36%), rest pain in seven patients (17%), and tissue loss in 19 patients (45%). There were 15 patients (36%) with TransAtlantic Inter-Society Consensus (TASC) A, nine patients (21%) with TASC B, five patients (12%) with TASC C, and 13 patients (31%) with TASC D lesions. The majority of lesions intervened on were the first attempt at revascularization. Three stents (7.7%) occluded within 30 days. One-year primary, primary-assisted, and secondary patency rates were 24%, 44%, and 51%, respectively. Limb salvage was 93% during follow-up. Seventeen interventions failed (40%) at 1 year. Of these, seven patients (41%) developed claudication, seven patients (41%) developed ischemic rest pain, and three patients (18%) were asymptomatic. During follow-up, three patients (7.7%) required bypass and three patients (7.7%) major amputation, one after failed bypass. All limbs requiring bypass or amputation had TASC C/D lesions. Thirty-day and 1-year mortality was 2.6% and 10.3%, respectively. Conclusions: Interventions performed for TASC C/D lesions are more likely to fail and more likely to lead to bypass or amputation. Interventions performed for TASC C/D lesions that fail have a negative impact on limb salvage. This should be considered when performing stenting of advanced SFA lesions.
Journal of Vascular Surgery, 2011
Few would argue with the need for long-term follow-up after endovascular repair of abdominal aort... more Few would argue with the need for long-term follow-up after endovascular repair of abdominal aortic aneurysms. A small risk of reintervention persists and the challenge remains to identify those patients that will require additional procedures to prevent subsequent complications. The ideal follow-up regimen remains elusive. Up until this point, most regimens have consisted of radiologic imaging, with either computed tomography (CT) scans or ultrasonography to identify continued aneurysm perfusion (endoleaks) and document sac dynamics, either shrinkage, growth, or stability. However, aneurysm sac growth or shrinkage serves only as a surrogate measurement for pressurization, and although it is uniformly believed that attachment site endoleaks require treatment, it remains controversial as to how to determine which type II endoleaks pressurize an aneurysm sufficiently to require therapy. In response to these difficulties, several manufacturers have developed pressure sensors that can be implanted at the time of the initial repair. They have been shown capable of measuring intrasac pressures that have appropriately responded to reinterventions for endoleaks. However, are they the answer we are looking for? Are they ready for widespread use? Do they offer a reliable and consistent measure of intrasac pressure that can be trusted to determine the need, or lack of need, for further therapy? Our debaters will try to convince us one way or another.
Journal of Vascular Surgery, 2010
Journal of Vascular Surgery, 2006
Journal of Vascular Surgery, 2006
Journal of Vascular Surgery, 2009
Objective: To determine event-free survival in patients requiring adjunctive aortic neck procedur... more Objective: To determine event-free survival in patients requiring adjunctive aortic neck procedures during endovascular aneurysm repair (EVAR). Methods: A retrospective review of 172 patients undergoing EVAR between 01/05 and 09/07 was performed. Data were analyzed by the need for an adjunct, defined as a proximal aortic cuff, Palmaz stent, or high-pressure balloon angioplasty. The primary outcome was event-free survival defined as survival without type I endoleak, sac enlargement, rupture, or subsequent neck-related procedure. Secondary outcomes included aneurysm-related and all-cause mortality, and any aneurysmrelated secondary procedures. Univariate analyses determined the relationship of outcome variables to aortic neck length, diameter, angulation, thrombus, presence of a reverse taper, endograft type, Palmaz stent use, and patient comorbidities. Results: 53 patients had 56 adjunctive neck-related procedures with a technical success rate of 97%. 119 patients did not require an adjunct. The one-year event-free survival was similar between the groups (96% and 98% respectively, p ϭ 0.88). There were no ruptures. 44 patients (83%) who received an adjunct had "hostile" neck anatomy. Univariate analysis revealed that placement of a Palmaz stent was associated with a reduction in eventfree survival (p ϭ 0.04). No other predictors of event-free survival were identified. Conclusions: Adjunctive treatment to the proximal neck does not compromise mid-term results for EVAR. Palmaz stent placement may identify patients prone to late complications.
Journal of Vascular Surgery, 2004
A 54-year-old man who underwent uneventful orthotopic heart transplantion 1 year previously had l... more A 54-year-old man who underwent uneventful orthotopic heart transplantion 1 year previously had low-grade fever and dyspnea. Imaging studies revealed an ascending aortic pseudoaneurysm (AAP), which was repaired with a 5-mm polyester patch, with circulatory arrest and cardiopulmonary bypass. Intraoperative cultures of the AAP grew methicillin-resistant Staphylococcus aureus, and the pseudoaneurysm recurred after 6 weeks despite intravenously administered antibiotic therapy. A 28.5-mm ؋ 3.3-cm Gore Excluder aortic cuff was deployed in the ascending aorta through a left axillary artery cutdown with use of combined transesophageal echocardiography and fluoroscopy. In addition, controlled hypotension and asystole were established with administration of adenosine to facilitate precise device deployment. Postoperative imaging with transesophageal echocardiography and magnetic resonance angiography revealed complete resolution of the AAP, and the patient had done well at 7-month follow-up. Treatment of a mycotic aortic pseudoaneurysm with an endoprosthesis in a patient without other treatment alternatives can be performed safely, with acceptable short-term results.
Journal of Vascular Surgery, 2010
Objective: This study was conducted to identify risk factors for late mortality after thoracic en... more Objective: This study was conducted to identify risk factors for late mortality after thoracic endovascular aortic repair (TEVAR). Methods: A retrospective analysis of consecutive TEVAR was conducted. Medical record review, telephone contact, or query of the Social Security Death Index was used to determine 30-day and late survival. Late mortality was assessed with respect to patient characteristics at the time of the initial treatment, preoperative laboratory values, pathology, clinical presentation, and treatment adjuncts. Significant univariate predictors of death were entered into a multivariate Cox proportional hazards model. Results: From 1998 to 2009, 252 patients (149 men; mean age, 68 years) underwent TEVAR for degenerative thoracic aortic aneurysm (TAA, n ؍ 143), type B dissection (n ؍ 62), mycotic aneurysm (n ؍ 13), traumatic disruption (n ؍ 12), penetrating ulcer or intramural hematoma (n ؍ 10), anastomotic pseudoaneurysm (n ؍ 4), or other pathology (n ؍ 8). The 30-day mortality was 9.5%, with stroke or spinal cord injury in 5.6%. Mean follow-up was 22 ؎ 22 months. Kaplan-Meier mean survival was 53 months. Predictors of late mortality by univariate analysis included age (P < .01), cardiac arrhythmia (P ؍ .03), chronic obstructive pulmonary disease (P ؍ .05), aneurysm diameter (P < .01), rupture (P < .01), debranching (P ؍ .02), leukocytosis (white blood cell count > 10.0 ؋ 10 3 /L; P < .01), albumin, (P < .01), and creatinine > 1.7 mg/dL (P ؍ .01). Multivariate predictors of mortality included rupture (hazard ratio [HR], 3.10; 95% confidence interval [CI], 1.02-9.44;
Journal of Clinical Medicine
The goal of this study was to describe the surgical results of physician-modified endografts (PME... more The goal of this study was to describe the surgical results of physician-modified endografts (PMEG) utilizing a 3D aortic template in a center with no prior experience in complex endovascular aortic repairs. Forty-three patients underwent physician-modified graft stent implantation using a 3D aortic model. The inclusion criteria were juxtarenal and suprarenal aortic aneurysms, type IV thoracoabdominal aneurysms, and type IA endoleak after endovascular aortic repair. In asymptomatic patients, the diameter threshold for aneurysm repair was 5.5 cm in males and 5.0 cm in females. 3D aortic templates were prepared from the patient’s computed tomography angiography scans and sterilized before use in the operating suite. Forty-three stent grafts were modified with the use of a 3D printing template. A total of 162 reinforced fenestrations (37 celiac, 43 right renal, 39 left renal, 43 superior mesenteric) with a mean of 3.8 per patient were performed. All PMEGs had a posterior reducing-diame...
Journal of Endovascular Therapy, 2003
To report an acute endograft limb occlusion immediately subsequent to a total hip replacement. Ca... more To report an acute endograft limb occlusion immediately subsequent to a total hip replacement. Case Report: A 62-year-old man underwent successful placement of a bifurcated stentgraft for a 5-cm abdominal aortic aneurysm (AAA). Surveillance imaging documented a satisfactory outcome and no defects in the stent-graft. Three months after the endograft procedure, he underwent left total hip arthroplasty, at which time the left endograft limb acutely thrombosed. He was successfully treated with thrombectomy and dilation/stenting of the thrombosed graft limb. Conclusions: Patients with aortoiliac stent-grafts need careful surveillance around the time of a procedure that may require extreme manipulation of the pelvis and hips. Even fully supported, widely patent endograft limbs may be vulnerable to acute thrombosis in this setting.
Journal of the American College of Surgeons, 2000
Journal of Vascular Surgery, 2014
the number of TAAA cases performed nationally and a decline in the rate of ruptured TAAA (P < .00... more the number of TAAA cases performed nationally and a decline in the rate of ruptured TAAA (P < .001). Conclusions: A decline in the number of TAAA cases was observed over the study period; however, the costs associated with treatment increased significantly. The overall in-hospital mortality is decreasing for TAAAs. A sharp rise in the use of endovascular techniques for the management of TAAA was seen over the study period. The overall mortality of TEVAR was significantly lower compared with OAR.
Figure 1. Computed tomography of small, calcified external iliac arteries.
European Journal of Vascular and Endovascular Surgery, 2019
iliac navigation without iliac complications, successful endograft deployment, renal and hypogast... more iliac navigation without iliac complications, successful endograft deployment, renal and hypogastric arteries patency at the end of the procedure, no evidence of type I-III endoleak at the end of the procedure, no conversion to open repair-OR, no intra-operative mortality), 30-days iliac arteries complications rate, 30-days endoleak rate and 30days mortality. Secondary end-points were: short-term endograft related re-intervention, iliac leg occlusion and AAA-related mortality. Both primary and secondary endpoints were evaluated for the whole sample and in patients whit (Group A) and without (Group B) hostile iliac anatomy (angle/tortuosity, diameter and calcifications). Iliac hostility was defined following Chaikof's classification 1. Univariate and multivariate analysis was performed using Chi-squared and Fischer Exact test. Results-During the enrollment period, 274 patients (male 91.6%;mean age 75.7;ASA 3/4, 66,4%/24,2%) were treated using Cook Zenith Alpha Abdominal Endograft for elective EVAR in 14 centres. TS was 98,5%. No intra operative mortality and immediate conversion to OR occurred. Thirtydays endograft-related reintervention, iliac leg occlusion, iliac leg complication and mortality rate were respectively 0,3% (1 case of type 1A endoleak treated with surgical conversion), 0%, 0% and 1,7% (non-procedure related 1,4%; procedure-related 0,3%). Two hundred sixty-two patients (95,6%) presented with accurate morphological data; 60 (22,9%) had at least one morphological aspect of iliac hostility. Univariate and multivariate analysis didn't show significant differences between Group A and B for any of primary and secondary end-points. Mean follow up was 4.96 months (0-14,3; SD 3,9). Survival rate was 96,7% with a AAA-related mortality, rupture, iliac leg occlusion and endograft related reintervention rate of 0%, 0%, 1,6% and 2,4% respectively. Iliac hostility didn't affect the short-term results. Conclusion-Our preliminary results suggest Cook Zenith Alpha Abdominal Endograft to be a safe and effective tool for EVAR in abdominal aortic aneurysms with severe iliac anatomy. References 1 Chaikof EL, Fillinger MF, Matsumura JS, Rutherford RB, White GH, Blankensteijn JD et al. Identifying and grading factors that modify the outcome of endovascular aortic aneurysm repair.
EJVES Vascular Forum, 2020
Introduction: This report presents the treatment of an aortic endovascular aneurysm repair (EVAR)... more Introduction: This report presents the treatment of an aortic endovascular aneurysm repair (EVAR) device failure, focusing on the use of colour duplex ultrasound (CDUS) to diagnose and confirm effective treatment of a type IIIb endoleak. Report: An 89 year old man with a history of EVAR was transferred to the authors' centre with complaints of abdominal pain and a pressure sensation behind the umbilicus. A previously stable 11 cm aneurysm sac was visualised on computed tomography angiography in addition to a newly suspected type IIIb endoleak, which was confirmed via CDUS. He underwent successful endovascular repair with a stent across the limb defect. The patient was discharged uneventfully and was followed for surveillance. Discussion: Type IIIb endoleak is an underreported complication after EVAR. CDUS of type IIIb endoleak aided in localisation and characterisation of the graft failure, and confirmed successful endovascular treatment of the endoleak defect in the side limb. Locating the point of graft failure using CDUS preceding endovascular repair of type IIIb endoleaks guides interventions and repair outcomes. It is a rare opportunity to report a case of acute type IIIb endoleak with CDUS that definitively localised an endograft defect.
Journal of Vascular Surgery, 2019
We have previously shown that patients with abdominal aortic aneurysm (AAA) have decreased number... more We have previously shown that patients with abdominal aortic aneurysm (AAA) have decreased number and diminished immune suppressive function of regulatory type 1 T cells (Tr1) and increased numbers of activated effector Th17 cells. The objective of this clinical trial was to assess the efficacy of allogeneic mesenchymal stem cells (MSCs) in inducing Tr1 cells and suppressing AAA inflammation. Methods: The AneuRysm Repression with mEsenchymal STem cells (ARREST) trial is a blinded, placebo-controlled phase 1 study in which patients with small AAA (30-to 50-mm diameter) are randomized to intravenous infusion of placebo (plasmalyte A), 1 million MSCs/kg, and 3 million MSCs/kg (n ¼ 12/group). Blood samples are collected at baseline and at days 3, 7, 14, 28, and 60 and yearly. The primary end point is change in the ratio of Tr1:Th17 cells at 14 days after treatment using flow cytometry. Secondary end points are changes in FoxP3 + T-regulatory cells, myeloid-derived suppressor cells, microRNA profiles, serum cytokine levels, changes in AAA inflammation as measured by 18-fluorodeoxyglucose positron emission tomography/computed tomography, and changes in aneurysm diameter and volume at years 1 to 5. Results: Twenty-one patients have been enrolled to date. There have been no treatment-related adverse events, and one patient withdrew after discovery of an occult pulmonary malignant neoplasm on baseline positron emission tomography/computed tomography. At day 14, the ratio of Tr1:Th17 cells increased by 20.3 6 1.3-fold from baseline for the highdose MSC group (n ¼ 7) compared with 4.3 6-fold for the low-dose group (n ¼ 7; P < .01) and À10 .66 2.3-fold for the placebo group (n ¼ 7; P ¼ .001; Fig). There was a decrease in 18-fluorodeoxyglucose uptake as measured by standard uptake values by 5.6% 61.3% in the combined MSC group (n ¼ 7) compared with an increase in standard uptake values of 4.1% 6 1.0% in the placebo group (n ¼ 4; P < .05). Although the sample size was too small for statistical comparison, the average increase in maximal transverse diameter of AAA at 12 months after treatment was À1.6 6 0.6 mm in the combined MSC group (n ¼ 4) and 4.3 6 0.9 mm in the placebo group. Conclusions: The results of the ARREST trial demonstrate a significant increase in Tr1 cells concurrent with a decrease in cytotoxic effector Th17 cells in an MSC dose-dependent fashion, achieving the primary end point. Preliminary data suggest that aneurysm inflammation and expansion are decreased with MSC treatment.
Journal of Vascular Surgery, 2011
artery localization, and completion angiography were done with CO 2 in all patients, including hy... more artery localization, and completion angiography were done with CO 2 in all patients, including hypogastric embolization in 26 cases. Preoperative national kidney foundation (NKF) glomerular filtration rate (GFR) classification was: normal in 16 patients, mildly decreased in 52, moderate to severely decreased in 44, and 2 were in renal failure. Results: All grafts were successfully deployed with no conversions. CO 2 angiography identified 20 endoleaks (2 type 1, 16 type 2 and 2 type 4) and 3 unintentionally covered arteries. Additional use of IC in 42 patients did not modify the procedure in any case. When compared with a cohort of 50 consecutive patients who underwent EVAR done exclusively with IC, the operative time was shorter with CO2 (177 vs 194 min; P ϭ .01); fluoroscopy time was less (21 vs 28 min; P ϭ .002), and volume of iodinated contrast was lower (37 vs 106 mLs; P Ͻ .001). Postoperatively, there was one death, one instance of renal failure, and no complications related to CO 2 use. Patients with moderate to severely decreased GFR undergoing EVAR with IC had a 12.7% greater (P ϭ .004) decrease in GFR compared with the CO 2 EVAR group. At one, six and 12 month follow-up, CTAs showed well positioned endografts with the expected patent renal and hypogastric arteries in all patients, and no difference in endoleak detection compared with the iodinated contrast EVAR group. During follow-up, 8 transluminal interventions and one open conversion were required, but no aneurysm related deaths occurred. Conclusions: CO 2 guided EVAR is technically feasible and safe, it eliminates or reduces the need for iodinated contrast use, may expedite the procedure, and avoids deterioration in renal function in patients with pre-existing renal insufficiency. A prospective trial comparing CO 2 with iodinated contrast during EVAR is warranted.
Journal of Vascular Surgery, 2011
Objectives: This study assessed the safety and efficacy of thoracic endovascular aortic repair (T... more Objectives: This study assessed the safety and efficacy of thoracic endovascular aortic repair (TEVAR) in the management of aortobronchial fistulas. Methods: A retrospective review was performed at Emory University Hospital to identify all patients who presented with an aortobronchial fistula. The diagnosis was based on clinical, radiologic, and bronchoscopic findings. Patients who underwent TEVAR as definitive management of these fistulas were identified. Demographics, history of thoracic aorta pathology or intervention, type and number of endografts used, need for reoperation, and clinical and radiologic follow-up data were collected for each individual. Results: Between 2000 and 2009, 11 patients received TEVAR as definitive management of aortobronchial fistulas. Technical success was achieved in 10 patients (91%). Six patients (55%) had previously undergone thoracic aortic surgery. A proximal type 1 endoleak developed in one patient after graft deployment and required reintervention for additional graft placement. No intraoperative or 30-day deaths occurred. Postoperative clinical and radiographic assessment was a mean of 8.8 months (range, 1-40 months). For all 10 patients in whom technical success was achieved at the initial operation, no endoleaks were noted at the follow-up CT scan. In addition, no patient required a further intervention. Conclusions: This study represents the largest reported series on the use of TEVAR in the management of aortobronchial fistulas. Supported by postoperative surveillance imaging and clinical evaluation, TEVAR has proven to be a safe and effective management strategy for an otherwise lethal condition. Long-term follow-up data are needed to ascertain the durability of this approach.
Journal of Vascular Surgery, 2005
Objective: Reports continue to document the occurrence of major adverse events after endovascular... more Objective: Reports continue to document the occurrence of major adverse events after endovascular aortic aneurysm repair. Although many of these problems can be successfully managed through endovascular salvage, operative conversion with explantation of the endoprosthesis remains necessary in some patients. We report herein a review of all patients initially enrolled in multicenter US clinical trials of the Excluder endograft who underwent secondary conversion to open surgical repair. Methods: Clinical data and relevant medical records of patients enrolled in phase I and II multicenter US clinical trials of the Excluder endograft were retrospectively reviewed for adverse events and further narrowed to those patients who underwent secondary operative conversion. Hospital records, operative and anesthesia reports, and all imaging studies were analyzed at initial implantation and at the time of subsequent open surgical repair. Results: Late open conversion was performed in 16 (2.7%) of the 594 patients enrolled in the Excluder clinical trials. Presumed endotension accounted for 8 of 16 of secondary conversions. In two of these patients, however, an endoleak was identified at the time of open surgical repair. Of the remaining eight patients, two underwent conversion for device infection, five for persistent endoleak, and one for aneurysm rupture. The overall 30-day mortality was 6.25% (1/16), with one death occurring in a patient with a ruptured aneurysm. Of patients who underwent conversion because of endotension, the maximal abdominal aortic aneurysm diameter (mean ؎ SD) at the time of initial implantation and subsequent graft removal was 61 ؎ 11 mm and 70 ؎ 10 mm, respectively. The mean time to open conversion for treatment of endotension was 37 ؎ 12 months (range, 20-50 months; median, 42 months). Freedom from conversion was 98.6% and 96.7% at 24 and 48 months, respectively. Conclusions: Endotension in the absence of a demonstrable endoleak has been a major indication for late surgical conversion in patients treated with the Excluder endograft. Given the potential presence of an undetected endoleak and the possible effects of progressive sac enlargement on long-term device stability, continued close surveillance of patients with assumed endotension is required. Should changes in device design eliminate endotension, a further reduction in the already low incidence of late open conversion of the Excluder endograft can be anticipated.
Journal of Vascular Surgery, 2010
Objective: This study evaluated the durability of adjunctive endovascular neck procedures, includ... more Objective: This study evaluated the durability of adjunctive endovascular neck procedures, including aortic cuffs, Palmaz stents (Cordis, Miami Lakes, Fla), and high-pressure balloon angioplasty, at managing intraoperative proximal neck complications during endovascular aortic aneurysm repair (EVAR). Methods: This was a single-center retrospective review of EVARs. The primary outcome variable studied was survival free of a graft-related event (GRE). GRE was defined by the occurrence of one of the following: type I endoleak, sac enlargement, aneurysm rupture, death, or procedure related to the aortic neck. These outcome variables were assessed relative to the preoperative anatomic neck variables (neck length, diameter, degree of angulation, degree of circumferential thrombus, and presence of conicity), procedural variables (manufacturing type of graft, use of a Palmaz stent), and patient characteristics (age and presence of medical comorbidities). Outcomes were assessed by t tests, Pearson 2 , and Kaplan-Meier analysis, when appropriate. Results: A total of 174 EVARs performed between January 2005 and December 2007 were evaluated. Fifty-six adjunctive procedures were performed, with a 97% primary-assisted exclusion rate. Patients who received an adjunctive therapy had similar freedom from a GRE compared with EVARs that did not require adjunctive therapy (35.5 ؎ 2.6 vs 34.8 ؎ 1.5 months, P ؍ .31, log-rank test). Subset analysis identified a significant association between Palmaz stent placement at the time of EVAR and decreased freedom from GREs (hazard ratio, 2.87; 95% confidence interval, 1.21-6.77; P ؍ .02). Conclusions: Midterm results suggest that adjunctive therapies to manage intraoperative proximal neck complications do not compromise durability. The subset of patients requiring aortic neck Palmaz stent placement at the time of EVAR are among those at highest risk for subsequent GRE.
Journal of Vascular Surgery, 2012
Endovascular treatment of superficial femoral artery (SFA) lesions is a well-established practice... more Endovascular treatment of superficial femoral artery (SFA) lesions is a well-established practice. The repercussions of failed SFA interventions are unclear. Our goal was to review the efficacy of SFA stenting and define negative effects of its failure. Methods: A retrospective chart review was conducted from January 2007 to January 2010 that identified 42 limbs in 39 patients that underwent SFA stenting. Follow-up ankle-brachial index and a duplex ultrasound scan was performed at routine intervals. Results: Mean patient age was 68 years (range, 43-88 years); there were 22 men (56%) and 17 women (44%). Intervention indication was claudication in 15 patients (36%), rest pain in seven patients (17%), and tissue loss in 19 patients (45%). There were 15 patients (36%) with TransAtlantic Inter-Society Consensus (TASC) A, nine patients (21%) with TASC B, five patients (12%) with TASC C, and 13 patients (31%) with TASC D lesions. The majority of lesions intervened on were the first attempt at revascularization. Three stents (7.7%) occluded within 30 days. One-year primary, primary-assisted, and secondary patency rates were 24%, 44%, and 51%, respectively. Limb salvage was 93% during follow-up. Seventeen interventions failed (40%) at 1 year. Of these, seven patients (41%) developed claudication, seven patients (41%) developed ischemic rest pain, and three patients (18%) were asymptomatic. During follow-up, three patients (7.7%) required bypass and three patients (7.7%) major amputation, one after failed bypass. All limbs requiring bypass or amputation had TASC C/D lesions. Thirty-day and 1-year mortality was 2.6% and 10.3%, respectively. Conclusions: Interventions performed for TASC C/D lesions are more likely to fail and more likely to lead to bypass or amputation. Interventions performed for TASC C/D lesions that fail have a negative impact on limb salvage. This should be considered when performing stenting of advanced SFA lesions.
Journal of Vascular Surgery, 2011
Few would argue with the need for long-term follow-up after endovascular repair of abdominal aort... more Few would argue with the need for long-term follow-up after endovascular repair of abdominal aortic aneurysms. A small risk of reintervention persists and the challenge remains to identify those patients that will require additional procedures to prevent subsequent complications. The ideal follow-up regimen remains elusive. Up until this point, most regimens have consisted of radiologic imaging, with either computed tomography (CT) scans or ultrasonography to identify continued aneurysm perfusion (endoleaks) and document sac dynamics, either shrinkage, growth, or stability. However, aneurysm sac growth or shrinkage serves only as a surrogate measurement for pressurization, and although it is uniformly believed that attachment site endoleaks require treatment, it remains controversial as to how to determine which type II endoleaks pressurize an aneurysm sufficiently to require therapy. In response to these difficulties, several manufacturers have developed pressure sensors that can be implanted at the time of the initial repair. They have been shown capable of measuring intrasac pressures that have appropriately responded to reinterventions for endoleaks. However, are they the answer we are looking for? Are they ready for widespread use? Do they offer a reliable and consistent measure of intrasac pressure that can be trusted to determine the need, or lack of need, for further therapy? Our debaters will try to convince us one way or another.
Journal of Vascular Surgery, 2010
Journal of Vascular Surgery, 2006
Journal of Vascular Surgery, 2006
Journal of Vascular Surgery, 2009
Objective: To determine event-free survival in patients requiring adjunctive aortic neck procedur... more Objective: To determine event-free survival in patients requiring adjunctive aortic neck procedures during endovascular aneurysm repair (EVAR). Methods: A retrospective review of 172 patients undergoing EVAR between 01/05 and 09/07 was performed. Data were analyzed by the need for an adjunct, defined as a proximal aortic cuff, Palmaz stent, or high-pressure balloon angioplasty. The primary outcome was event-free survival defined as survival without type I endoleak, sac enlargement, rupture, or subsequent neck-related procedure. Secondary outcomes included aneurysm-related and all-cause mortality, and any aneurysmrelated secondary procedures. Univariate analyses determined the relationship of outcome variables to aortic neck length, diameter, angulation, thrombus, presence of a reverse taper, endograft type, Palmaz stent use, and patient comorbidities. Results: 53 patients had 56 adjunctive neck-related procedures with a technical success rate of 97%. 119 patients did not require an adjunct. The one-year event-free survival was similar between the groups (96% and 98% respectively, p ϭ 0.88). There were no ruptures. 44 patients (83%) who received an adjunct had "hostile" neck anatomy. Univariate analysis revealed that placement of a Palmaz stent was associated with a reduction in eventfree survival (p ϭ 0.04). No other predictors of event-free survival were identified. Conclusions: Adjunctive treatment to the proximal neck does not compromise mid-term results for EVAR. Palmaz stent placement may identify patients prone to late complications.
Journal of Vascular Surgery, 2004
A 54-year-old man who underwent uneventful orthotopic heart transplantion 1 year previously had l... more A 54-year-old man who underwent uneventful orthotopic heart transplantion 1 year previously had low-grade fever and dyspnea. Imaging studies revealed an ascending aortic pseudoaneurysm (AAP), which was repaired with a 5-mm polyester patch, with circulatory arrest and cardiopulmonary bypass. Intraoperative cultures of the AAP grew methicillin-resistant Staphylococcus aureus, and the pseudoaneurysm recurred after 6 weeks despite intravenously administered antibiotic therapy. A 28.5-mm ؋ 3.3-cm Gore Excluder aortic cuff was deployed in the ascending aorta through a left axillary artery cutdown with use of combined transesophageal echocardiography and fluoroscopy. In addition, controlled hypotension and asystole were established with administration of adenosine to facilitate precise device deployment. Postoperative imaging with transesophageal echocardiography and magnetic resonance angiography revealed complete resolution of the AAP, and the patient had done well at 7-month follow-up. Treatment of a mycotic aortic pseudoaneurysm with an endoprosthesis in a patient without other treatment alternatives can be performed safely, with acceptable short-term results.
Journal of Vascular Surgery, 2010
Objective: This study was conducted to identify risk factors for late mortality after thoracic en... more Objective: This study was conducted to identify risk factors for late mortality after thoracic endovascular aortic repair (TEVAR). Methods: A retrospective analysis of consecutive TEVAR was conducted. Medical record review, telephone contact, or query of the Social Security Death Index was used to determine 30-day and late survival. Late mortality was assessed with respect to patient characteristics at the time of the initial treatment, preoperative laboratory values, pathology, clinical presentation, and treatment adjuncts. Significant univariate predictors of death were entered into a multivariate Cox proportional hazards model. Results: From 1998 to 2009, 252 patients (149 men; mean age, 68 years) underwent TEVAR for degenerative thoracic aortic aneurysm (TAA, n ؍ 143), type B dissection (n ؍ 62), mycotic aneurysm (n ؍ 13), traumatic disruption (n ؍ 12), penetrating ulcer or intramural hematoma (n ؍ 10), anastomotic pseudoaneurysm (n ؍ 4), or other pathology (n ؍ 8). The 30-day mortality was 9.5%, with stroke or spinal cord injury in 5.6%. Mean follow-up was 22 ؎ 22 months. Kaplan-Meier mean survival was 53 months. Predictors of late mortality by univariate analysis included age (P < .01), cardiac arrhythmia (P ؍ .03), chronic obstructive pulmonary disease (P ؍ .05), aneurysm diameter (P < .01), rupture (P < .01), debranching (P ؍ .02), leukocytosis (white blood cell count > 10.0 ؋ 10 3 /L; P < .01), albumin, (P < .01), and creatinine > 1.7 mg/dL (P ؍ .01). Multivariate predictors of mortality included rupture (hazard ratio [HR], 3.10; 95% confidence interval [CI], 1.02-9.44;
Journal of Clinical Medicine
The goal of this study was to describe the surgical results of physician-modified endografts (PME... more The goal of this study was to describe the surgical results of physician-modified endografts (PMEG) utilizing a 3D aortic template in a center with no prior experience in complex endovascular aortic repairs. Forty-three patients underwent physician-modified graft stent implantation using a 3D aortic model. The inclusion criteria were juxtarenal and suprarenal aortic aneurysms, type IV thoracoabdominal aneurysms, and type IA endoleak after endovascular aortic repair. In asymptomatic patients, the diameter threshold for aneurysm repair was 5.5 cm in males and 5.0 cm in females. 3D aortic templates were prepared from the patient’s computed tomography angiography scans and sterilized before use in the operating suite. Forty-three stent grafts were modified with the use of a 3D printing template. A total of 162 reinforced fenestrations (37 celiac, 43 right renal, 39 left renal, 43 superior mesenteric) with a mean of 3.8 per patient were performed. All PMEGs had a posterior reducing-diame...
Journal of Endovascular Therapy, 2003
To report an acute endograft limb occlusion immediately subsequent to a total hip replacement. Ca... more To report an acute endograft limb occlusion immediately subsequent to a total hip replacement. Case Report: A 62-year-old man underwent successful placement of a bifurcated stentgraft for a 5-cm abdominal aortic aneurysm (AAA). Surveillance imaging documented a satisfactory outcome and no defects in the stent-graft. Three months after the endograft procedure, he underwent left total hip arthroplasty, at which time the left endograft limb acutely thrombosed. He was successfully treated with thrombectomy and dilation/stenting of the thrombosed graft limb. Conclusions: Patients with aortoiliac stent-grafts need careful surveillance around the time of a procedure that may require extreme manipulation of the pelvis and hips. Even fully supported, widely patent endograft limbs may be vulnerable to acute thrombosis in this setting.
Journal of the American College of Surgeons, 2000