Results of the North American Complex Abdominal Aortic Debranching (NACAAD) Registry.

BACKGROUND: Hybrid debranching repair of pararenal and thoracoabdominal aortic aneurysms was initially designed as a better alternative to standard open repair, addressing the limitations of endovascular repair involving the visceral aorta. We reviewed the collective outcomes of hybrid debranching repairs using extra-anatomic, open surgical debranching of the renal-mesenteric arteries, followed by endovascular aortic stenting. METHODS: Data from patients who underwent hybrid repair in 14 North American institutions during 10 years were retrospectively reviewed. Society of Vascular Surgery scores were used to assess comorbidity risk. Early and late outcomes, including mortality, morbidity, reintervention, and patency were analyzed. RESULTS: A total of 208 patients (118 male; mean age, 71±8 years old) were treated by hybrid repair with extraanatomic reconstruction of 657 renal and mesenteric arteries (mean 3.2 vessels/patient). Mean aneurysm diameter was 6.6±1.3 cm. Thoracoabdominal aortic aneurysms were identified in 163 (78%) patients and pararenal aneurysms in 45 (22%). A single-stage repair was performed in 92 (44%) patients. The iliac arteries were the most common source of inflow (n=132; 63%), and most (n=150; 72%) had 3 or more bypasses. There were 30 (14%) early deaths, ranging widely across sites (0%-21%). A Society of Vascular Surgery comorbidity score >15 was the primary predictor of early mortality (P<0.01), whereas mortality was 3% in a score ≤9. Early complications occurred in 140 (73%) patients and included respiratory complications in 45 patients (22%) and spinal cord ischemia in 22 (11%), of whom 10 (45%) fully recovered. At 5 years, survival was 61±5%, primary graft patency was 90±2%, and secondary patency was 93±2%. The most significant predictor of late mortality was renal insufficiency (P<0.0001). CONCLUSIONS: Mortality after hybrid repair and visceral debranching is highly variable by center, but strongly affected by preoperative comorbidities and the centers' experience with the technique. With excellent graft patency at 5 years, the outcomes of hybrid repair done at centers of excellence and in carefully selected patients may be comparable (or better) than traditional open or even totally endovascular approaches. However, in patients already considered as high-risk for surgery, it may not offer better outcomes.

Risk factors for spinal cord injury and complications of cerebrospinal fluid drainage in patients undergoing fenestrated and branched endovascular aneurysm repair.

OBJECTIVE: Spinal cord injury (SCI) is one of the most devastating complications of thoracoabdominal aortic aneurysm (TAAA) repair. Cerebrospinal fluid drainage (CSFD) is routinely used to prevent and to treat SCI during open TAAA repair. However, the risks and benefits of CSFD during fenestrated-branched endovascular aneurysm repair (F/B-EVAR) are unclear. This study aimed to determine the risk of SCI after F/B-EVAR and to assess the risks and benefits of CSFD. METHODS: We analyzed 106 consecutive patients with TAAAs treated with F/B-EVAR from 2014 to 2019 in a prospective physician-sponsored investigational device exemption study (G130193). Data were collected prospectively and audited by an independent external monitor. All patients were treated with Cook manufactured patient-specific F/B-EVAR devices or the Cook t-Branch devices (Cook Medical, Bloomington, Ind). CSFD was used at the discretion of the principal investigator. Risk factors for SCI were identified, and CSFD complications were assessed. RESULTS: Prophylactic CSFD was used in 78 patients (73.6%), and 28 patients (26.4%) underwent F/B-EVAR without CSFD. Four patients (3.8%) with prophylactic CSFD developed SCI, including two patients (1.9%) with permanent paraplegia (Tarlov grade 1-2) and two patients (1.9%) with paraparesis (Tarlov grade 3). Multivariate analysis revealed that greater extent of thoracic aortic coverage (odds ratio, 1.06; 95% confidence interval, 1.00-1.11; P = .02) and intraoperative blood loss (odds ratio, 1.00; 95% confidence interval, 1.00-1.002; P = .04) were the significant risk factors for SCI. Six patients (7.6% [6/78]) experienced major CSFD-related complications, including subarachnoid hemorrhage in 2.6% (2), spinal hematoma in 2.6% (2), cerebellar hemorrhage in 1.3% (1), and spinal drain fracture requiring surgical laminectomy in 1.3% (1). Minor CSFD-related complications occurred in 20 patients (25.6% [20/78]), including paresthesia during CSFD insertion (10), minimal bloody cerebrospinal fluid (7), drain malfunction (2), and reflex hypotension (1). Technical difficulties during CSFD catheter placement were noted in seven patients (9.0%). Excluding four patients with SCI, intensive care unit stay was 3.3 ± 4.0 days in the CSFD group vs 1.2 ± 0.9 days in the no-CSFD group (P = .007). Total hospital length of stay was 6.0 ± 4.9 days in the CSFD group vs 3.5 ± 1.9 days in the no-CSFD group (P = .01). CONCLUSIONS: The incidence of SCI after F/B-EVAR with selective CSFD was low, and risk factors for SCI were greater with extent of thoracic aortic coverage and intraoperative blood loss. However, the incidence of major CSFD-related complications exceeded the incidence of SCI, and CSFD significantly increased both intensive care unit and total hospital length of stay. Therefore, routine prophylactic CSFD may not be justified, and a prospective randomized trial of CSFD in patients undergoing F/B-EVAR seems appropriate.

Managing central venous access during a health care crisis.

OBJECTIVE: During the COVID-19 pandemic, central venous access line teams were implemented at many hospitals throughout the world to provide access for critically ill patients. The objective of this study was to describe the structure, practice patterns, and outcomes of these vascular access teams during the COVID-19 pandemic. METHODS: We conducted a cross-sectional, self-reported study of central venous access line teams in hospitals afflicted with the COVID-19 pandemic. To participate in the study, hospitals were required to meet one of the following criteria: development of a formal plan for a central venous access line team during the pandemic; implementation of a central venous access line team during the pandemic; placement of central venous access by a designated practice group during the pandemic as part of routine clinical practice; or management of an iatrogenic complication related to central venous access in a patient with COVID-19. RESULTS: Participants from 60 hospitals in 13 countries contributed data to the study. Central venous line teams were most commonly composed of vascular surgery and general surgery attending physicians and trainees. Twenty sites had 2657 lines placed by their central venous access line team or designated practice group. During that time, there were 11 (0.4%) iatrogenic complications associated with central venous access procedures performed by the line team or group at those 20 sites. Triple lumen catheters, Cordis (Santa Clara, Calif) catheters, and nontunneled hemodialysis catheters were the most common types of central venous lines placed by the teams. Eight (14%) sites reported experience in placing central venous lines in prone, ventilated patients with COVID-19. A dedicated line cart was used by 35 (59%) of the hospitals. Less than 50% (24 [41%]) of the participating sites reported managing thrombosed central lines in COVID-19 patients. Twenty-three of the sites managed 48 iatrogenic complications in patients with COVID-19 (including complications caused by providers outside of the line team or designated practice group). CONCLUSIONS: Implementation of a dedicated central venous access line team during a pandemic or other health care crisis is a way by which physicians trained in central venous access can contribute their expertise to a stressed health care system. A line team composed of physicians with vascular skill sets provides relief to resource-constrained intensive care unit, ward, and emergency medicine teams with a low rate of iatrogenic complications relative to historical reports. We recommend that a plan for central venous access line team implementation be in place for future health care crises.

Carbon Dioxide Angiography in the Treatment of Transplant Renal Artery Stenosis.

BACKGROUND: Transplant renal artery stenosis (TRAS) is a serious complication associated with graft loss. Selective carbon dioxide angiography allows for effective diagnosis and therapy with the use of minimal to no contrast agent. This study sought to evaluate the efficacy of the adjunctive use of carbon dioxide angiography in the treatment of TRAS. METHODS: Patients undergoing endovascular therapy (percutaneous transluminal angioplasty with or without stent) for TRAS between the years 2012 and 2017 at a single tertiary care academic medical center were studied. Outcomes of interest included technical success, postoperative glomerular filtration rate, and renal ultrasound hemodynamic parameters. RESULTS: Of the 37 patients who underwent angiography for TRAS during the study period, 34 underwent a therapeutic intervention. Of those, 24 patients (70.6%) underwent adjunctive carbon dioxide angiography versus 10 patients (29.4%) who underwent standard contrast angiography. Baseline characteristics between the carbon dioxide angiography and traditional angiography groups were similar. Patients undergoing carbon dioxide angiography received significantly less contrast agent than patients undergoing traditional angiography [9.5 mL (IQR 2-19.5) versus 19.5 mL (IQR 15-30), P = 0.03)] and maintained equivalent technical success rates (92.2% vs. 91.7%, P = 0.9). CONCLUSIONS: The adjunctive use of carbon dioxide angiography allows for significantly less contrast administration compared with standard angiography while achieving an equivalent rate of technical success. Selective carbon dioxide angiography should be considered a first-line modality for patients with TRAS in need of endovascular therapy.

Safety and Effectiveness of Percutaneous Axillary Artery Access for Complex Aortic Interventions.

BACKGROUND: The aim of this study is to evaluate the safety and effectiveness of percutaneous axillary artery access in patients requiring upper extremity large sheath access during complex aortic interventions. METHODS: Consecutive patients who had percutaneous axillary artery access with a large-bore sheath during endovascular thoracoabdominal aortic artery aneurysm repair within an Food and Drug Administration-approved, physician-sponsored investigational device exemption study or visceral artery interventions during other complex aortic interventions were included in the study. All patients had percutaneous axillary artery ultrasound-guided access and deployment of 2 Perclose ProGlide devices (Abbott Vascular, Santa Clara, CA) prior to introduction of a large sheath. Completion angiography was performed to assess technical success of percutaneous access site closure, which was defined as hemostatic arterial closure without evidence of axillary artery stenosis or occlusion requiring intervention. Follow-up computed tomography scans and patient records were also reviewed for access site associated complications. RESULTS: A total of 46 patients underwent percutaneous axillary artery access. Largest sheath profile was 16F in 1 (2%), 12F in 42 (91%), 10F in 1 (2%), 9F in 1 (2%), and 8F in 1 (2%) patient. Technical success was achieved in 41 of 46 patients (89%). Five patients required endovascular covered stent placement during the index operation to control persistent access site bleeding. Two of 46 patients (4%) suffered access-related complications; both patients experienced ipsilateral upper extremity paresthesias without motor weakness, with persistent digit numbness in one. There was no incidence of conversion to open axillary artery repair and no additional access site complications (stenosis, occlusion, or dissection) but neurologic complications were observed during follow-up. CONCLUSIONS: Percutaneous axillary artery access can be used to provide upper extremity arterial access during complex aortic interventions with high rates of safety and technical success. Overall complication rates are low and occurred mainly during the early experience, indicating that there is an associated learning curve effect. Elimination of surgical cutdown incisions and arterial conduits by using percutaneous axillary access may reduce operative times and wound-related complications during complex aortic interventions requiring large-bore upper extremity access.

Safety and Effectiveness of Retrograde Arterial Access for Endovascular Treatment of Critical Limb Ischemia.

BACKGROUND: Retrograde arterial access (RA) of the popliteal, tibial, or pedal arteries may facilitate endovascular treatment of complex infrainguinal lesions in patients with critical limb ischemia (CLI). Here, we assess the safety and efficacy of this technique. METHODS: A retrospective review of prospectively collected institutional data (consecutive M2S entries) was performed to identify patients with CLI undergoing peripheral vascular intervention from February 2012 through December 2017. Demographics, comorbidities, procedural characteristics, and outcomes were analyzed, and comparisons were made between outcomes of patients undergoing RA and those undergoing a standard antegrade access (SA) approach. RESULTS: Five hundred sixty-six patients were identified, of whom 26 (4.6%) underwent RA. Of these, 4 were accessed via the popliteal artery (15.4%), 13 via the tibial vessels above the ankle (50.0%), and 9 via pedal vessels (34.6%). RA facilitated procedural success in 96.2% of cases. There were no instances of distal embolization, perforation, or loss of distal target with RA. Primary, primary assisted, and secondary patency rates were consistently lower for RA patients than for SA patients, as was limb salvage and amputation-free survival. No difference was seen in overall survival. CONCLUSIONS: RA represents a viable and safe option for revascularization when SA fails. Although outcomes are poorer than SA, this technique can be useful in CLI patients, especially when open surgical revascularization is not an option.

Transradial interventions in contemporary vascular surgery practice.

OBJECTIVES: Upper extremity arterial access is often required for endovascular procedures, especially for antegrade access to the visceral aortic branches. Radial arterial access has been shown previously to have low complication rates, and patients tolerate the procedure well and are able to recover quickly. However, transradial access remains relatively uncommon amongst vascular surgeons. METHODS: The radial artery was evaluated by ultrasound to evaluate for adequate caliber, and to identify any aberrant anatomy or arterial loops. A modified Barbeau test was performed to ensure sufficient collateral circulation. A cocktail of nitroglycerin, verapamil and heparin was administered intra-arterially to combat vasospasm. Sheaths up to 6 French were utilized for interventions. On completion of the procedure, a compression band was used for hemostasis in all cases. RESULTS: Twenty-five interventions were performed in 24 patients. The left radial artery was used in 23/25 cases (92.0%). Procedures included visceral and renal artery interventions; stent graft repair of a renal artery aneurysm; embolization of splenic, pancreaticoduodenal and internal mammary aneurysms; embolization of bilateral hypogastric arteries following blunt pelvic trauma; interventions for peripheral arterial disease; delivery of a renal snorkel graft during endovascular aortic aneurysm repair, and access for diagnostic catheters during thoracic endovascular aortic aneurysm repair. Technical success was 92.0%. There was one post-operative radial artery occlusion (4.3%) which led to paresthesias but resolved with anticoagulation. There were no instances of arterial rupture, hematoma, or hand ischemia requiring intervention. CONCLUSIONS: Using the transradial approach, we have demonstrated a high technical success rate over a range of clinical contexts with minimal morbidity and no significant complications such as bleeding or hand ischemia. The safety profile compares favorably to historical complication rates from brachial access. Radial access is a safe and useful skill for vascular surgeons to master.

Analysis of the Learning Curve and Patient Outcomes of Endovascular Repair of Thoracoabdominal Aortic Aneurysms Using Fenestrated and Branched Stent Grafts: Prospective, Nonrandomized, Single-center Physician-sponsored Investigational Device Exemption Clinical Study.

OBJECTIVE: To evaluate the outcomes and learning curve of fenestrated and branched endovascular repair (F/BEVAR) of thoracoabdominal aneurysms. SUMMARY OF BACKGROUND DATA: Endovascular aneurysm repair has reduced morbidity and mortality compared with open surgical repair. However, application to thoracoabdominal aneurysm repair remains limited by procedural complexity and device availability. METHODS: Fifty patients treated in a prospective, nonrandomized, single-center Investigational Device Exemption (IDE) study between January 2014 and July 2017 were analyzed. Patients (mean age 75.6 ±â€Š7.5 years; mean aneurysm diameter 67.3 ±â€Š9.8 mm) underwent F/BEVAR of thoracoabdominal aneurysms (58% type IV; 42% type I-III) using custom-manufactured endografts. The experience was divided into 3 cohorts (Early: 1 to 17; Mid: 18 to 34; Late: 35 to 50) to evaluate learning curve effects on key process measures. RESULTS: F/BEVAR included 194 visceral arteries (average 3.9 per patient). Technical success was 99.5% (193/194 targeted arteries). Thirty-day major adverse events (MAEs) included 3 (6%) deaths, 1 (2%) new-onset dialysis, 3 (6%) paraparesis/paraplegia, and 2 (4%) strokes. One-year survival was 79 ±â€Š7%. Comparing the Early and Late groups revealed reductions in procedure time (452 ±â€Š74 vs 362 ±â€Š53 minutes; P = 0.0001), fluoroscopy time (130 ±â€Š40 vs 99 ±â€Š27 minutes; P = 0.016), contrast administration (157 ±â€Š73 vs 108 ±â€Š38 mL; P = 0.028), and estimated blood loss (EBL; 1003 ±â€Š933 vs 481 ±â€Š317 mL; P = 0.042). Intensive care unit (ICU) and total length of stay (LOS) decreased from 4 ±â€Š3 to 2 ±â€Š1 days and from 7 ±â€Š6 to 5 ±â€Š2 days, respectively, but was not statistically significant. CONCLUSIONS: Use of F/BEVAR for treatment of thoracoabdominal aneurysms is safe and effective. During this early experience, there was a significant improvement in key process measures reflecting improvements in technique and physician learning over time.

Risk Factors for Suboptimal Utilization of Statins and Antiplatelet Therapy in Patients Undergoing Revascularization for Symptomatic Peripheral Arterial Disease.

BACKGROUND: The objective of this study was to identify risk factors for suboptimal medical therapy (defined as reported antiplatelet and statin use) among patients undergoing lower extremity bypass (LEB) and peripheral vascular interventions (PVIs) for symptomatic peripheral arterial disease (PAD). METHODS: The Vascular Study Group of Greater New York (VSGGNY) database was used to identify all patients undergoing PVI or LEB for PAD (2011-2013). Bivariate analyses were performed to identify characteristics of patients who were not prescribed statins and/or antiplatelet agents before revascularization. Multivariate relative risk regression models were developed to identify patients at risk for suboptimal therapy, with regards to antiplatelet and statin therapy. RESULTS: About 1,030 patients underwent endovascular therapy (n = 822; 80%) or surgical bypass (n = 208; 20%) for symptomatic PAD (57.2% claudication; 15% rest pain and 27.8% tissue loss). Overall, preoperative statin use was observed in 59%. Preoperative antiplatelet therapy was observed in 79% of patients. Bivariate analysis revealed comparatively reduced statin use among patients without other cardiovascular risk factors including hypertension (63% vs. 39.3%; P < 0.0001) and coronary artery disease (CAD) with or without prior cardiac revascularization (coronary artery bypass grafting [CABG]/percutaneous coronary intervention [PCI]; 75.2% vs. 47.4%; P < 0.0001). Multivariate relative risk regression confirmed higher rates of statin use among patients with other cardiovascular risk factors including hypertension (1.14 [1.02-1.27]; P = 0.02) and CAD with prior CABG/PCI (1.22 [1.13-1.31]; P < 0.0001). Reduced statin use was observed in patients over 80 years old. (0.92 [0.84-0.1.0]; P = 0.059). By multivariate regression, antiplatelet therapy use was associated with CAD and/or prior CABG/PCI (1.11 [1.04-1.17]; P = 0.0015) and prior peripheral revascularization (1.07 [1.01-1.13]; P = 0.03). CONCLUSIONS: Patients with symptomatic PAD, but without an antecedent cardiovascular history, are less likely to be optimally managed with statins and antiplatelet therapy preoperatively. Given the established role of these medications in the optimal medical management of patients with PAD, this presents an opportunity for improvement in the overall vascular care of patients undergoing intervention for symptomatic PAD at VSGGNY centers.

Utility and safety of axillary conduits during endovascular repair of thoracoabdominal aneurysms.

OBJECTIVE: Endovascular treatment of thoracoabdominal aortic aneurysms (TAAAs) with branched and fenestrated stent grafts often requires upper extremity arterial access for antegrade delivery of bridging covered stents into the visceral arteries. Axillary, brachial, and radial artery approaches have been described, but data on the safety and utility of the different approaches remain limited. We have preferentially used axillary artery conduits for upper extremity arterial access during endovascular repair of TAAA and describe our technique and report our experience herein. METHODS: Thirty-two patients were treated within an investigator-sponsored investigational device exemption clinical trial of endovascular repair of TAAAs using custom-manufactured stent grafts. In 29 of these cases, the axillary artery was exposed through an infraclavicular incision, and an axillary conduit was used for antegrade delivery of bridging visceral artery stent components. In all cases, a 12F sheath was placed through the conduit for delivery of stent graft components. The left axillary artery was used in 27 of these 29 cases, and the right axillary artery was used in 2 patients. Proximal brachial artery access was used in two patients, and one patient did not require upper extremity access. Aneurysms treated included pararenal (n = 3) and Crawford TAAA extent I (n = 1), extent II (n = 3), extent III (n = 10), and extent IV (n = 15). Patients have been followed up to 2 years after the procedure, with a mean follow-up of 226 days. RESULTS: Axillary conduits were used to deliver a total of 170 stent components placed into 81 branches and 27 fenestrations with 99.1% technical success (one accessory renal branch could not be cannulated). There were no intraoperative complications related to the construction or use of the conduit. There were two postoperative complications (6.9%) potentially attributable to the conduit; one patient experienced ipsilateral hand weakness and one patient had postoperative minor stroke, which resolved by the first postoperative visit. There were no cases of arm ischemia, wound hematoma, or reoperation related to the conduit. CONCLUSIONS: The use of an axillary conduit during endovascular repair of complex aortic aneurysms provides safe and effective upper extremity access for delivery of visceral branches. Moreover, axillary conduits facilitate delivery of 12F sheaths without interrupting upper extremity perfusion and provide a shorter working distance compared with brachial artery approaches.

Patient-reported Quality of Life after Endovascular Repair of Thoracoabdominal Aortic Aneurysms.

BACKGROUND: The purpose of this study is to assess patient-reported physical and emotional well-being during follow-up after endovascular repair of thoracoabdominal aortic aneurysm (TAAA). METHODS: All patients were treated in the context of a physician-sponsored investigational device exemption clinical study for patients at high risk for open TAAA repair. The short form 36 (SF-36) instrument was administered preoperatively, and at 1, 6, and 12 months. Results were analyzed using paired t-tests, with subgroup comparisons to assess the impact of adverse events and technical results on quality of life. RESULTS: Twenty-two patients (77% male) with a history of prior aortic surgery (60%), chronic kidney disease (23%), and age >75 years (77%) underwent endovascular TAAA repair. The majority of patients presented with extent III (41%) or IV (41%) aneurysms. Cumulative branch/fenestration patency was 100% and 96% and 1 and 6 months, respectively. At 1 month, patients reported lower scores across most of the SF-36 domains. Scores in role functioning, vitality, and social functioning were significantly lower than preoperatively (P < 0.05). At 6 months, patient-reported outcomes improved to preoperative levels, although patients who experienced moderate or severe adverse events in the perioperative period had lower baseline physical and emotional health. CONCLUSIONS: Endovascular TAAA repair results in reduced physical and mental health in the acute setting, irrespective of technical success or adverse events. By 6 months, however, patient-reported well-being returns to baseline levels. Ongoing efforts will continue to assess the effectiveness of endovascular TAAA repair from the patient-centered standpoint.

Hybrid Repair Techniques for Complex Aneurysms and Dissections Involving the Aortic Arch and Thoracic Aorta.

Aortic aneurysms involving the ascending aorta, aortic arch, and descending thoracic aorta have been a challenging entity to surgically treat for over 60 years. Despite the mortality of the disease, early open surgical procedures also had significant morbidity and mortality. The inherent risk in treating multiple anatomic segments simultaneously led to the innovation of the staged elephant trunk (ET) approach by Borst in 1983. To avoid the thoracotomy and associated complications related to the second stage of the procedure, an endovascular completion paradigm was begun by Volodos in 1991. This theoretical hybrid technique combinined shorter and less elaborate open supra-aortic trunk debranching with less invasive endovascular exclusion and has grown since then in terms of different approaches and case volume. The rise of thoracic endovascular aortic repair (TEVAR) combined with debranching bypass has allowed certain lesions to be treated without a large scale intrathoracic open surgical procedure. The complexity and extensiveness of certain lesions, however, has necessitated a hybrid approach such as the frozen elephant trunk (FET) and the standard ET with second stage TEVAR. The former has been used to treat multifocal degenerative aneurysms, chronic dissections with aneurysm, and acute extensive dissections. After conventional proximal aortic replacement, a stent-graft (SG) is delivered antegrade through the transected arch where it is sutured proximally and then "frozen" distally via endovascular means. The FET has the advantage of avoiding a second stage, but potentially introduces a greater rate of spinal cord ischemia compared to the standard elephant trunk. Improvements on the FET procedure have included the development of more advanced hybrid SG such as the Vascutek® Thoraflex™ Hybrid graft (Vascutek Ltd, Scotland, UK), which consists of a distal en,dograft sealed to a proximal four-branched Vascutek Gelweave™ Vascutek Ltd, Scotland, UK) and incorporated sewing collar. While open surgery continues to be a component of complex aortic arch aneurysms, the development of hybrid devices that can bridge the gap between open and endovascular surgery will continue to flourish.

Evolution of gender-related differences in outcomes from two decades of endovascular aneurysm repair.

OBJECTIVE: Women have been under-represented in trials that set guidelines for the management of aortic aneurysms. Several studies reported inferior outcomes in women compared with men after endovascular aneurysm repair (EVAR). We investigated the relationship between gender and outcomes after EVAR. METHODS: A total of 1380 consecutive patients underwent elective EVAR from 1992 to 2012. Baseline, intraoperative, and postoperative variables by gender were analyzed from a prospective database. RESULTS: The cohort comprised 214 women (15.5%) and 1166 men (84.5%). Women were older than men at repair (77.8 vs 74.5 years, P < .001) and had less cardiac disease (P = .005). They had shorter (19.8 ± 12.9 vs 26.3 ± 14.7 mm; P < .001) more angulated aortic necks (38.8° ± 16.1° vs 31.2° ± 14.7°; P < .001) and fewer iliac aneurysms (P = .002). Women had more arterial reconstructions (iliac conduits, P = .006; thrombolysis and thrombectomy, P = .013; patch angioplasty, P < .001; endarterectomy, P < .001), more perioperative complications (16.9% vs 9.1%; P = .001), and more in-hospital days (4.1 vs 3.4 days; P = .029). Perioperative mortality was equivalent (women: 2% vs men: 2.3%; P = .73). Mean follow-up was 30.9 months. Women and men experienced equivalent aneurysm-related deaths and overall survival. Survival curve analysis showed endoleaks were more likely to develop in women than men (P = .005); however, there was no difference in rates of arterial reinterventions required for each gender during the follow-up period. CONCLUSIONS: Female gender is associated with more periprocedural complications, adjunctive arterial procedures, and increased endoleaks but does not affect long-term reinterventions or survival. Further studies are warranted to elucidate the effect of gender on outcomes. These data should be considered when selecting EVAR for men and women.

The impact of stent graft evolution on the results of endovascular abdominal aortic aneurysm repair.

OBJECTIVE: There have been four eras in the development of endovascular aneurysm repair (EVAR): physician-made grafts, early industry devices, intermediary commercial endografts, and modern stent grafts. This study analyzes differences in outcomes between these four groups and the impact of device evolution and increased physician experience. METHODS: From 1992 to 2012, 1380 patients underwent elective EVAR. Fourteen different devices were used during this time. The four generations were defined as follows: era 1, all physician-made devices; era 2, June 1994 to June 2003; era 3, June 2003 to January 2008; and era 4, January 2008 to July 2012. Grafts used in each era were the following: era 1, physician made; era 2, early industry, such as EVT, Talent, AneuRx, Excluder, Quantum LP, Vanguard, Ancure, and Teramed; era 3, Talent, Endologix, Excluder, AAAdvantage, Zenith, and Aptus; and era 4, Zenith, Endurant, and Excluder. RESULTS: Mean age was 75.2 years, and 84.5% were men. Adjunctive procedures decreased from era 1 to era 2 (P < .001) but rose again in eras 3 and 4 (P < .001). Procedure times (P < .001), blood loss (P < .001), and length of stay (P < .001) have decreased in eras 2, 3, and 4 compared with era 1. Major perioperative complications (era 1, 23%; era 2, 5.9%; era 3, 4.9%; and era 4, 4.7%; P < .001), abdominal aortic aneurysm-related perioperative mortality (era 1, 4.3%; era 2, 0.2%; era 3, 0.06%; and era 4, 0.5%; P < .001), and all-cause perioperative mortality (era 1, 7.7%; era 2, 1.9%; era 3, 1.5%; and era 4, 0.47%; P < .001) have also decreased in eras 2, 3, and 4 compared with era 1. Type I and type III endoleaks (P < .001) and the need for reintervention (P < .001) have decreased. Freedom from aneurysm-related mortality has significantly improved. CONCLUSIONS: EVAR has evolved during the last 20 years, resulting in an improvement in efficiency, outcomes, and procedural success. The most significant advance is seen in the transition from era 1 to the later eras.

Clinical application and early outcomes of the aortouni-iliac configuration for endovascular aneurysm repair.

OBJECTIVE: The objective of this study was to review the current anatomic indications for and early results of aortouni-iliac (AUI) devices for endovascular aneurysm repair. METHODS: A total of 128 patients receiving an Endurant (Medtronic Inc, Minneapolis, Minn) AUI device in the U.S. Investigational Device Exemption trial (44 patients) or the Endurant Stent Graft Natural Selection Global Postmarket Registry (84 patients) were reviewed. Preoperative computed tomography imaging of patients in the Investigational Device Exemption trial and case report forms of Registry patients were used to determine anatomic indications. Baseline characteristics and early results were compared with those of 1305 patients receiving a bifurcated (BIF) device in sister studies. RESULTS: The indication for the AUI device was unclear from case report forms in two Registry cases. The remaining 126 patients had a unilateral iliac occlusion in 30 (23%), a severely narrowed aortic segment in 58 (45%), severe iliac occlusive disease in 28 (22%), severe iliac tortuosity in 29 (23%), or complex iliac aneurysms in 19 (15%). Two patients had a previous aortobifemoral graft; 38 patients (30%) had multiple indications. The AUI cohort included more women than the BIF group did (19% vs 10%; P < .01) and had more severe comorbidities. Successful deployment was achieved in all AUI cases. The 30-day mortality was 2% (BIF cohort, 1%; P = .21). More AUI patients underwent repair under general anesthesia (81% vs 64%; P < .01), and procedures were longer (110.9 ± 54.9 minutes vs 99.2 ± 44.3 minutes; P = .02). Except for longer intensive care unit stays (19.6 ± 80.0 hours vs 9.0 ± 34.8 hours; P = .01) and higher myocardial infarction rates (4% vs 1%; P < .01), outcomes of the AUI cohort were similar to those of the BIF cohort. There were no migrations, ruptures, fractures, or open conversions at up to 1-year follow-up. CONCLUSIONS: The AUI configuration extends endovascular aneurysm repair feasibility to several hostile anatomic conditions. Despite increased comorbidities in the recipient patient population and associated higher rates of postoperative myocardial infarction and respiratory complications, early outcomes with the new generation of AUI devices are acceptable and comparable to those after treatment with BIF configurations.

Revascularization for critical limb ischemia using the SpiderFX embolic protection device in the below-the-knee circulation: initial results.

PURPOSE: To examine the safety and efficacy of the SpiderFX embolic protection device (EPD) in the below-the-knee (BTK) circulation in patients with critical limb ischemia (CLI). MATERIALS AND METHODS: A single-center retrospective review was performed to identify patients with CLI and single-vessel runoff in whom the SpiderFX EPD was used in the BTK circulation. Technical success and device-related complications were the primary endpoints. Retrieval of macroscopic debris in the EPD, 1-year freedom from major adverse limb events (MALEs), and 30-day perioperative death were also evaluated. A major amputation, surgical bypass, endovascular thrombectomy, or endovascular thrombolysis was considered a MALE. Thirty-six patients (21 men; mean age, 75.8 y) treated between 2008 and 2013 had endovascular revascularization with use of the SpiderFX EPD in the BTK circulation. RESULTS: The SpiderFX EPD was successfully deployed in all cases; the technical success rate of revascularization was 100%. Two minor and zero major complications were observed related to the SpiderFX. Two MALEs, a major amputation and a subsequent surgical bypass, were observed in the cohort. All MALEs occurred within 1 year of treatment (1-y freedom from MALE rate, 90%). Debris was retrieved in the SpiderFX device in 47% of patients. CONCLUSIONS: The use of the SpiderFX EPD in the BTK circulation in patients with CLI is safe and frequently retrieves debris.

The impact of sex on angioplasty and primary stenting for femoropopliteal occlusive disease: results of the DURABILITY II trial.

BACKGROUND: This study investigates the impact of sex on angioplasty and primary stenting for the treatment of claudicants with femoropopliteal occlusive disease (FPOD). METHODS: Two hundred eighty-seven patients enrolled in the Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis (DURABILITY II) trial (a prospective, nonrandomized, core laboratory audited, and independently adjudicated investigational device exemption trial) were stratified by sex (190 men and 97 women) and reviewed. RESULTS: Women presented with FPOD at an older age than men (71.3 ± 11.2 vs. 65.9 ± 9.9 years; P < 0.001). Men were more likely to be hyperlipidemic (89.5% vs. 79.4%; P = 0.030). No other statistically significant differences were observed with regard to periprocedural comorbidities and demographics. Clinically, women presented more often with severe claudication (64.9% vs. 51.1%; P = 0.033) as compared with men that had more moderate claudication (44.2% vs. 29.9%; P = 0.022). The incidence of rest pain and tissue loss was low and did not vary between sexes. Angiographically, women had smaller reference vessels (4.4 ± 0.8 mm vs. 5.0 ± 0.9 mm; P < 0.001). Longer lesions (91.6 ± 46.8 mm vs. 87.8 ± 43.9 mm) and higher primary (79.0% vs. 76.5%), primary-assisted (90.6% vs. 85.1%), and secondary patency (90.6% vs. 85.7%) rates in women did not achieve statistical significance (P = NS). Mean percent stenosis and occlusion rates were similar between groups, but men were more likely to have severe calcification (47.9% vs. 34.0%; P = 0.020). Inter-Society Consensus for the Management of Peripheral Arterial Disease II classifications were similar between groups. The target lesion revascularization, major adverse event, and mortality rates were similar between groups. At baseline, the absolute claudication distance was 0.29 miles for men, while women only reached 0.14 miles (P < 0.0001). Walking improvement questionnaire scores were also compared; women had significantly lower scores at baseline and at 1 year. CONCLUSIONS: Despite presenting with FPOD at a later age, with more severe claudication, a shorter absolute claudication distance, and smaller vessels than men, women achieved equal patency rates using angioplasty and primary stenting with similar target lesion revascularization, major adverse event, and mortality rates. Despite these findings, women subjectively have worse symptoms at baseline and at 1 year.

Update in the use of branched and fenestrated endografts to treat aortic aneurysms.

Endovascular aneurysm repair is now the preferred method of abdominal and thoracic aneurysm repair. Until recently, the limitation with this technology has been preservation of the visceral vasculature, hypogastric arteries, and the great vessels. The Zenith® Fenestrated (Cook, Bloomington, IN) is the first device available for use in the US for treatment of para-renal or juxta-renal aneurysms. A multitude of new devices are now being investigated for use in the US to treat complex aneurysm morphology. Many of these devices are already being used internationally. Cook Medical has developed three additional devices designed to treat visceral segment aneurysms and to maintain hypogastric patency. Most notable is the Zenith® t-Branch™, which is capable of treating thoracoabdominal aortic aneurysms. Gore Medical (Flagstaff, AZ), has also developed two new devices, a thoracic branch device to maintain left subclavian artery patency and an iliac branch device. Medtronic (Minneapolis, MN) has also developed a thoracic branch device. Kawasumi laboratories (Tokyo, Japan) have also pioneered an endograft capable of treating aortic arch aneurysms. The feasibility of treating aneurysms along the entire aortic length is rapidly becoming a reality. Preliminary data on these new devices demonstrate excellent technical success with acceptable morbidity and mortality rates.

Presentation and management of true aneurysms of the pancreaticoduodenal arcade with concomitant celiac artery stenosis using the endovascular approach.

True aneurysms of the pancreaticoduodenal artery (PDA) arcade are rare but require intervention due to the high risk of rupture. Historically, these aneurysms have been managed with open surgical methods. In this study, we describe a contemporary series of aneurysms treated using a modern approach that includes endovascular and hybrid techniques. All the patients with aneurysms of the PDA arcade in an institutional database were identified between 2008 and 2022. Patients with history of pancreatic resection were excluded. Data on demographics, presenting symptoms, imaging findings, operative approach, and outcomes were collected and reviewed. There were nine patients diagnosed with a PDA aneurysm, and all nine underwent endovascular intervention. Most were men (n = 5; 55.6%) and White (n = 7; 77.8%) and had American Society of Anesthesiologists class II or III. The median aneurysm size was 21 mm (range, 6-42 mm), and five (55.5%) were symptomatic. Of the five symptomatic cases, two presented with rupture and were treated urgently. The median time to intervention for the nonurgent cases was 30 days. All but one patient had concomitant celiac artery stenosis and two of the eight cases (25%) were due to extrinsic compression from median arcuate ligament syndrome. Both patients underwent median arcuate ligament syndrome release before endovascular intervention. Another patient required open surgical bypass before endovascular repair from the supraceliac aorta to hepatic artery using a Dacron graft to maintain hepatic perfusion. Among the eight patients with celiac axis stenosis, five (62.5%) required celiac stent placement within the same operation. Coil embolization of the aneurysm was used for all except for two patients (n = 7 of 9; 77.8%), with one patient receiving embolic plugs and another receiving an 8 × 38-mm balloon-expandable covered stent for aneurysm exclusion. The median operating room time was 134 minutes. All repairs were technically successful without any intraoperative or postoperative complications. The mean follow-up was 30 months. There was no morbidity, mortality, or unplanned secondary reinterventions within 6 months after aneurysm repair. Stent patency and aneurysm size remained stable at 2 years of follow-up. True pancreaticoduodenal artery arcade aneurysms can be safely and effectively treated using endovascular and hybrid techniques. Because many of these aneurysms have concomitant celiac artery stenosis, the use of endovascular technology allows for simultaneous treatment of both the aneurysm and the stenosis with exceptional results.

Left subclavian artery coverage during thoracic endovascular aortic aneurysm repair does not mandate revascularization.

OBJECTIVE: This study assessed the risk of left subclavian artery (LSA) coverage and the role of revascularization in a large population of patients undergoing thoracic endovascular aortic aneurysm repair. METHODS: A retrospective multicenter review of 1189 patient records from 2000 to 2010 was performed. Major adverse events evaluated included cerebrovascular accident (CVA) and spinal cord ischemia (SCI). Subgroup analysis was performed for noncovered LSA (group A), covered LSA (group B), and covered/revascularized LSA (group C). RESULTS: Of 1189 patients, 394 had LSA coverage (33.1%), and 180 of these patients (46%) underwent LSA revascularization. In all patients, emergency operations (9.5% vs 4.3%; P=.001), renal failure (12.7% vs 5.3%; P=.001), hypertension (7% vs 2.3%; P=.01), and number of stents placed (1=3.7%, 2=7.4%, ≥3=10%; P=.005) were predictors of SCI. History of cerebrovascular disease (9.6% vs 3.5%; P=.002), chronic obstructive pulmonary disease (9.5% vs 5.4%; P=.01), coronary artery disease (8.5% vs 5.3%; P=.03), smoking (8.9% vs 4.2%) and female gender (5.3% men vs 8.2% women; P=.05) were predictors of CVA. Subgroup analysis showed no significant difference between groups B and C (SCI, 6.3% vs 6.1%; CVA, 6.7% vs 6.1%). LSA revascularization was not protective for SCI (7.5% vs 4.1%; P=.3) or CVA (6.1% vs 6.4%; P=.9). Women who underwent revascularization had an increased incidence of CVA event compared with all other subgroups (group A: 5.6% men, 8.4% women, P=.16; group B: 6.6% men, 5.3% women, P=.9; group C: 2.8% men, 11.9% women, P=.03). CONCLUSIONS: LSA coverage does not appear to result in an increased incidence of SCI or CVA event when a strategy of selective revascularization is adopted. Selective LSA revascularization results in similar outcomes among the three cohorts studied. Revascularization in women carries an increased risk of a CVA event and should be reserved for select cases.