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.

Retrograde Endovascular With Intimal Re-Entry Through Endarterectomy: The REWIRE Technique.

OBJECTIVE: Hybrid lower extremity revascularization has been well described, typically consisting of common femoral endarterectomy (CFE) followed by direct patch puncture and endovascular treatment of any distal disease. We describe a modified technique that obviates the need for endovascular re-entry and simplifies treatment at the proximal and distal endpoints. METHODS: The REWIRE technique begins with retrograde arterial access via a patent tibial, pedal or femoropopliteal vessel. The diseased segment is crossed in the subintimal plane. Once the wire reaches the common femoral artery (CFA), the vessel is surgically exposed. Arteriotomy is performed and the wire is externalized during standard CFE. With through-wire access achieved, a sheath is inserted and the distal disease is treated. The proximal extent of the endovascular revascularization is incorporated into a standard CFE with patch angioplasty. RESULTS: Seven patients with chronic limb-threatening ischemia were treated with this approach, all with long segment occlusions of the SFA and significant CFA disease. The SFA disease was stented and bovine pericardial patch was used for CFE in all. Technical success was achieved in all patients. There were no complications related to the retrograde puncture site, which was controlled with manual pressure (4) or excluded with a covered stent (3). Thirty-Day freedom from major adverse limb events was 100%. CONCLUSIONS: The REWIRE technique is an effective approach to hybrid revascularization involving the CFA. By crossing the occluded segment in a retrograde fashion and surgically externalizing the wire during CFE, the proximal and distal endpoints can be addressed with ease, the profunda femoris is protected under direct visualization, and the need for endovascular re-entry is eliminated.

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.

Impact of surgeon and hospital experience on outcomes of abdominal aortic aneurysm repair in New York State.

OBJECTIVE: This study aimed to assess the impact of the surgeon's and hospital's experience on the outcomes of open surgical repair (OSR) and endovascular aneurysm repair (EVAR) of intact and ruptured abdominal aortic aneurysms (AAAs) in New York State. METHODS: New York Statewide Planning and Research Cooperative System data were used to identify patients undergoing AAA repair from 2000 to 2011. Characteristics of the provider and hospital were determined by linkage to the New York Office of Professions and National Provider Identification databases. Distinct hierarchical logistic regression models for EVAR and OSR for intact and ruptured AAAs were created to adjust for the patient's comorbidities and to evaluate the impact of the surgeon's and hospital's experience on outcomes. The provider's years since medical school graduation as well as annual volume of the facility and provider are examined in tertiles. Adjusted odds ratios and 95% confidence intervals are presented. RESULTS: A total of 18,842 patients underwent AAA repair by a vascular surgeon. For intact AAAs (n = 17,118), 26.2% of patients underwent OSR and 73.8% underwent EVAR. For ruptured AAAs (n = 1724), 63.9% underwent OSR and 36.1% underwent EVAR. After intact AAA repair, OSR adjusted outcomes were significantly influenced by the surgeon's annual volume but not by the facility's volume or the surgeon's age. The lowest volume providers (1-4 OSRs) had higher in-hospital mortality rates than high-volume (>11 OSRs) surgeons (adjusted odds ratio, 1.87 [95% confidence interval, 1.1-3.17]). Low-volume providers also had higher odds of major complications (1.23 [1-1.51]). For patients with intact AAA undergoing EVAR, mortality was higher at low-volume facilities (2.6 [1.3-5.3] and 2.7 [1.5-4.8] for <33 EVARs and 34-81 EVARs, respectively). After OSR for ruptured AAA, treatment at a low-volume facility (<9 OSRs for ruptured AAA) was associated with greater mortality than at high-volume (>27 OSRs for ruptured AAA) centers (1.56 [1.02-2.39]), whereas low-volume physicians (<4 OSRs for ruptured AAA) had higher odds of major complications (1.58 [1.04-2.41]). In the case of EVAR for rupture, there were no characteristics of the hospital or surgeon significantly associated with poorer outcomes. CONCLUSIONS: For intact AAA, the surgeon's volume was an important factor for OSR outcomes, whereas low facility volume was associated with worse outcomes after EVAR. For ruptured AAA, low-volume surgeons and low-volume facilities had worse outcomes after OSR but not after EVAR. The interaction between the surgeon's volume and the hospital's volume is complex and varies on the basis of the acuity of presentation and treatment modality.

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.

Safety and Effectiveness of a "Percutaneous-First" Approach to Endovascular Aortic Aneurysm Repair.

BACKGROUND: Percutaneous endovascular aneurysm repair (PEVAR) has been increasingly used in the endovascular treatment of abdominal aortic aneurysms. Furthermore, the percutaneous approach can be used with minimal sedation and local anesthesia in most cases. The purpose of this study was to assess the safety and effectiveness of a "percutaneous first" approach to femoral access for EVAR. METHOD: From 2012 to 2014, PEVAR has been the preferred approach to femoral access for EVAR at our institution. Retrospective review of institutional vascular quality initiative data was used to compare outcomes with elective PEVAR to a contemporary institutional series of elective EVAR via open femoral exposure. These 2 patient groups were compared with assess perioperative outcomes, procedural details (including anesthesia modality, procedure time, and length of stay [LOS]) and access-related complications between groups. RESULTS: One hundred two consecutive patients underwent attempted PEVAR and were compared with 98 patients undergoing surgical femoral exposure. Demographics and comorbidities were similar between groups, although there was a greater proportion of smokers in the PEVAR group (76.5% vs. 63.3%; P = 0.04). PEVAR was associated with an increased utilization of local anesthesia (67.6% vs. 12.2%; P < 0.001). PEVAR was associated with shorter postoperative LOS (mean 1.7 vs. 3.0 days; P = 0.035), shorter procedure times (137 vs. 222 min; P < 0.001), and significantly less blood loss (169 vs. 481 mL; P < 0.001). There were 5 access-site complications (4.9%) in the PEVAR group requiring conversion to open femoral exposure, compared with 2 patients (2.0%) with access-related complications after open femoral exposure (P = 0.09). There were significantly more hematomas in the PEVAR group (9.8% vs. 2.0%, P = 0.02). However, there were no significant differences in overall postoperative complications, wound infection, or ICU LOS. CONCLUSIONS: A "PEVAR first" approach proved feasible in the overwhelming majority of patients. Conversion to open transfemoral exposure was rare. PEVAR facilitated endovascular abdominal aortic aneurysm repair under local anesthesia in most patients and resulted in decreased procedural morbidity and resource utilization.

Impact of Provider Characteristics on Outcomes of Carotid Endarterectomy for Asymptomatic Carotid Stenosis in New York State.

BACKGROUND: The purpose of this study is to explore the impact of surgeon characteristics (including annual volume, specialty, and years in practice) on outcomes of carotid endarterectomy (CEA) for asymptomatic carotid atherosclerosis in New York State. METHODS: The New York Statewide Planning and Cooperation System database was utilized to identify patients undergoing CEA from 2004 to 2011. Provider characteristics were determined by linkage to the New York Office of Professions and National Provider Identification databases. Provider-level factors were characterized by defining 5 quintiles of equal size for each factor. Hierarchical logistic regression models were created to evaluate the impact of provider characteristics on outcome. RESULTS: In total, 36,495 patients underwent CEA for asymptomatic disease performed by vascular (75.7%), general (16.1%), cardiac (6%), and neuro (2.1%) surgeons. Outcomes of interest included in-hospital mortality (0.26%), stroke (0.45%), and the composite end point of mortality, stroke, or cardiac complication (2.2%). Unadjusted outcomes improved with increasing surgeon annual CEA volume. Mid-career surgeons had lower mortality and stroke rates than early or late-career surgeons. Odds of mortality were increased when surgery was performed by the lowest volume providers (quintile 1; 0-11 CEA/year) (odds ratio [OR] 2.62, 95% confidence interval [CI] 1.3-5.28) or a nonspecialty trained (general) surgeon (OR 1.64, 95% 1.01-2.67). After adjustment for all patient-level factors, provider volume remained an independent predictor of outcome, with significantly increased odds of mortality for volume quintile 1 (OR 2.57, 95% CI 1.27-5.23) and quintile 2 (12-22 CEA/year) (0.30%; OR 2.07, 95% CI 1-4.27) surgeons. CONCLUSIONS: Adverse events after CEA for asymptomatic disease are comparatively rare. However, surgeon characteristics impact outcome, with the best results offered by high-volume, mid-career, specialty-trained surgeons. Efforts to define the optimal treatment of asymptomatic carotid atherosclerosis must account for the impact of surgeon characteristics on patient outcomes.

Comparative effectiveness of peripheral vascular intervention versus surgical bypass for critical limb ischemia in the Vascular Study Group of Greater New York.

OBJECTIVE: In this study, the effectiveness of peripheral vascular intervention (PVI) was compared with surgical bypass grafting (BPG) for critical limb ischemia (CLI) in the Vascular Study Group of Greater New York (VSGGNY). METHODS: Patients undergoing BPG or PVI for CLI at VSGGNY centers (2011-2013) were included. The Society for Vascular Surgery objective performance goals for CLI were used to directly compare the safety and effectiveness of PVI and BPG. Propensity score matching was used for risk-adjusted comparisons of PVI with BPG. RESULTS: A total of 414 patients (268 PVI, 146 BPG) were treated for tissue loss (69%) or rest pain (31%). Patients undergoing PVI were more likely to have tissue loss (74.6% vs 57.5%; P < .001) and comorbidities such as diabetes (69.3% vs 57.5%; P = .02), heart failure (22% vs 13.7%; P = .04), and severe renal disease (13.1% vs 4.1%; P = .004). No significant differences were found between the groups across a panel of safety objective performance goals. In unadjusted analyses at 1 year, BPG was associated with higher rates of freedom from reintervention, amputation, or restenosis (90.4% vs 81.7%; P = .02) and freedom from reintervention or amputation (92.5% vs 85.8%, P = .045). After propensity score matching, PVI was associated with improved freedom from major adverse limb events and postoperative death at 1 year (95.6% vs 88.5%; P < .05). CONCLUSIONS: By unadjusted comparison, early reintervention and restenosis are more prevalent with PVI. However, risk-adjusted comparison underscores the safety and effectiveness of PVI in the treatment of CLI.

Safety and Effectiveness of Adjunctive Intra-Arterial Abciximab in the Management of Acute Limb Ischemia.

BACKGROUND: Contemporary endovascular management of acute limb ischemia (ALI) generally consists of tissue plasminogen activator (tPA) based catheter-directed thrombolysis (CDT) with or without pharmacomechanical thrombectomy (PMT). Although abciximab (Reopro), a GPIIb/IIIa receptor antagonist, is widely used in coronary revascularization, its safety and effectiveness in the treatment of ALI are unknown. Here, we review our contemporary experience with the endovascular management of ALI and assess the safety and effectiveness of abciximab. METHODS: A total of 49 consecutive patients with Rutherford class II (RII) ALI undergoing CDT for ALI from 2011 to 2014 was identified. Demographics, procedural details, and outcomes were assessed and are reported. RESULTS: A total of 44 patients with RII ALI underwent tPA-based CDT in 49 discrete interventions. In 11 patients adjunctive abciximab infusion was also used. The majority (82%) of patients treated with tPA ± PMT required overnight infusion and at least one subsequent procedure. Single-stage (on-table) thrombolysis was achieved in 91% of cases with adjunctive abciximab use versus 18% with tPA alone (P < 0.001). There was significantly less need for intensive care unit (ICU) monitoring, and there were no bleeding complications associated with adjunctive abciximab use. Overall length of stay and total operating room (OR) time favored the abciximab group but did not reach statistical significance. Overall primary patency, secondary patency, and amputation-free survival were 46 ± 9.9%, 79 ± 6.6%, and 78 ± 9.2% at 1 year. CONCLUSIONS: Early results suggest adjunctive abciximab may safely facilitate on-table thrombolysis for RII ALI. This approach appears to be associated with reduced resource utilization including fewer procedures, shorter OR time, and less ICU admissions. One-year outcomes compare favorably to a similar cohort of ALI patients treated with tPA-based therapy alone.

Characterizing the evolution of perioperative outcomes and costs of endovascular abdominal aortic aneurysm repair.

OBJECTIVE: The purpose of this study is to characterize the evolution in perioperative outcomes and costs of endovascular abdominal aortic aneurysm (AAA) repair (EVAR) by detailing changes in adjusted outcomes and costs over time. METHODS: National Inpatient Sample (2000-2011) data were used to evaluate patient characteristics, outcomes, and perioperative costs for elective EVAR performed for intact AAA. Outcomes were adjusted for patient demographics and comorbidities, and hospital factors by multivariate analysis. Costs were calculated from hospital cost to charge ratio files and adjusted to 2011 dollars. RESULTS: From 2000 to 2011, 185,249 patients underwent elective EVAR for intact AAA. The absolute rates of in-hospital major morbidity, mortality, and procedural costs all decreased significantly over time (P < .0001). The prevalence of major comorbidities in patients undergoing EVAR, including obesity, diabetes, and dyslipidemia, all increased significantly over time. After adjusting for multiple demographics, comorbidities, and hospital-level factors, recent outcomes of EVAR (2009-2011) remain superior to the early experience (2000-2002) with respect to mortality and major complications. CONCLUSIONS: From 2000-2011, the perioperative outcomes of EVAR improved significantly despite a higher prevalence of comorbidities among patients undergoing repair. Concurrently, procedure-associated costs declined. Advanced technology is often implicated in escalating healthcare spending, and the value of novel techniques is often questioned. These findings highlight that, in the case of EVAR, procedural outcomes have improved while the initial costs of repair have declined over time. EVAR offers an interesting example for stakeholders to consider in the era of cost-containment pressures and criticism of nascent, expensive technology in healthcare.

Outcomes and risk factors of cardiac arrest after vascular surgery procedures.

BACKGROUND: Despite increased awareness of the value of discussing patients' goals of care, advance directives, and code status as part of the surgical informed consent process, the actual outcomes and risks of cardiopulmonary resuscitation (CPR) remain poorly defined among some subsets of surgical patients. Thus, in an effort to generate an evidence base for communication about shared decision making and informed consent for vascular surgery patients and their surrogates, we defined the incidence, risks, and outcomes of postoperative cardiac arrest after primary vascular surgery procedures. METHODS: The 2007 to 2010 National Surgical Quality Improvement Program data were queried to develop a multi-institutional database of patients undergoing vascular surgery (N = 123,581). Univariate analyses and multivariate logistic regression were used to identify crude and adjusted risk factors for postoperative cardiac arrest requiring CPR and to assess outcomes. RESULTS: Postoperative cardiac arrest requiring CPR was seen in 1234 of 123,581 patients (1.0%) after vascular surgery at a mean of 7.2 ± 2 days. The 30-day mortality was 73.4% compared with 2.7% among patients who did not arrest (P < .001). Of CPR survivors, 102 (12.1%) were still hospitalized at 30 days. Patient variables that were most predictive of postoperative cardiac arrest included dependent functional status (odds ratio [OR], 2.9; 95% confidence interval [CI], 2.3-3.6; P < .001), dialysis dependence (OR, 2.7; 95% CI, 2.3-3.2; P < .001), emergent case (OR, 2.2; 95% CI, 1.9-2.5; P < .001), and preoperative ventilator dependence (OR, 2.0; 95% CI, 1.5-2.7; P < .001). Procedures associated with the highest risk included thoracic aortic surgery (OR, 6.9; 95% CI, 4.8-9.9; P < .001), open abdominal procedures (OR, 3.7; 95% CI, 3.1-4.4; P < .001), axillary-femoral bypass (OR, 2.1; 95% CI, 1.3-3.2; P = .001), and peripheral embolectomy (OR, 1.5; 95% CI, 1.2-1.9; P = .002). At least one major complication preceded cardiac arrest in 47.7% of patients including sepsis (23.5%), renal failure (14.5%), and myocardial infarction (12.1%). Patients with do not resuscitate orders were significantly less likely to undergo CPR (OR, 0.59; 95% CI, 0.39-0.93; P = .021). CONCLUSIONS: Patients undergoing vascular surgery who suffer a postoperative cardiac arrest frequently die in spite of receiving CPR; for those who survive, there is likely to be prolonged hospitalization and significant morbidity. These data provide an evidence base for discussing goals of care, advance directives, and code status with vascular surgery patients and their surrogates. Further research into how to best communicate risk, to elicit patient preferences, and to engage in shared decision making is needed.

Indocyanine Green Angiography Aids in Prediction of Limb Salvage in Vascular Trauma.

BACKGROUND: In cases of severe vascular trauma, traditional means for assessing viability using Doppler and angiography can have limited application. Indocyanine green angiography (ICGA) allows for a rapid qualitative assessment of tissue perfusion that serves as an important adjunct to these traditional methods, which can also be particularly helpful in guiding therapy. METHODS/RESULTS: We present a case of complicated ankle fracture with severe vascular compromise, which illustrates the role of ICGA as an assessment tool to guide therapy and decision-making in cases of acute limb threat. ICGA using SPY system (Novadaq, Bonita Springs, FL) was performed as part of our initial assessment to evaluate the extent of malperfusion and potential for revascularization. Preprocedural imaging with ICGA showed very limited uptake in the foot. Treatment was also performed with traditional angiography and infusion of intra-arterial nitroglycerin into the posterior tibial artery. Postprocedure imaging with ICGA was performed a day later and showed marked difference in the perfusion profile, with rapid uptake into the forefoot and toes, which corresponded with the patient's clinical improvement. The patient went on to have complete limb salvage. CONCLUSIONS: The addition of ICGA for assessment of tissue perfusion in cases of complex vascular trauma has several implications: it guides surgical therapy for excision of devitalized tissue and aids in decision-making for major considerations such as revascularization efforts or amputation.

Safety and effectiveness of endovascular therapy for claudication in octogenarians.

BACKGROUND: Advanced age (≥ 80 years) has been associated with adverse outcomes after lower extremity bypass for critical limb ischemia (CLI), but endovascular therapy (ET) is reported to have comparable safety across age groups. Here, we assess the safety and effectiveness of advanced age on outcomes after ET for lifestyle-limiting intermittent claudication (IC). METHODS: A retrospective review of a prospectively maintained institutional database (2007-2012) identified all patients undergoing ET for IC. Demographics, procedural details, and outcomes were assessed via univariate analysis and multivariate Cox regression. Effectiveness was assessed across a panel of outcome metrics including the following: overall survival, freedom from major adverse limb event (MALE), and freedom from reintervention, amputation, or restenosis (RAS). Freedom from MALE + perioperative death (MALE + POD) was the primary safety end point. RESULTS: Two hundred thirty-six patients underwent primary ET for 284 affected limbs. Of these, 46 interventions (16%) were performed in patients ≥ 80 years old. The average age of octogenarians treated was 84.4 years compared with 67.4 years among those aged <80 (P < 0.001). Compared with younger claudicants, octogenarians were less likely to have hypercholesterolemia (43.5% vs. 63.9%, P = 0.01) and more likely to deny a history of smoking (41.3% vs. 14.7%, P < 0.001). Octogenarians were also more likely to undergo interventions involving the popliteal artery (50% vs. 31.9%, P = 0.03). There were no other significant differences in demographics, comorbidities, TransAtlantic Inter-Society Consensus II classification, or treated arterial segment. Thirty-day freedom from MALE + POD was 100% in octogenarians and 99.6% in patients <80 years, with no difference between age groups. There were no differences in freedom from MALE, freedom from RAS, or overall survival at 1- and 3-year follow-up. CONCLUSIONS: Although age >80 years has been identified as an independent risk factor for poor outcomes in the surgical treatment of CLI, our results suggest that ET for selected octogenarians with lifestyle-limiting claudication is as safe and effective as ET in younger patients. Advanced age alone should not prohibit consideration of ET for patients with IC.

Risk factors of nonretrieval of retrievable inferior vena cava filters.

BACKGROUND: Optimal use of retrievable inferior vena cava (IVC) filters is an important health care issue, and despite an exponential rise in the use of retrievable IVC filters, national trends suggest that most of these filters are not removed. The purpose of this study was to identify risk factors associated with nonretrieval of retrievable IVC filters at our institution. METHODS: A retrospective institutional review of all patients undergoing IVC filter placement from June 2010 to June 2012 was performed. A number of patient parameters were studied, including relevant demographics, indication for filter placement, clinical history, related hospitalization, and whether filter retrieval was performed. Patient parameters were compared by univariate and multivariate logistic regression analyses. RESULTS: There were 605 retrievable IVC filters placed over a 24-month period by vascular surgery, intervention radiology, and interventional cardiology. The follow-up retrieval rate was 25%. By indication, 272 (45%), 53 (9%), and 280 (46%) filters were placed for absolute, relative, and prophylactic indications, respectively. Independent predictors for nonretrieval by multivariate analysis were age >80 years (hazard ratio [HR], 5.0; 95% confidence interval [CI], 1.7-20; P < 0.001), acute bleed (HR, 2.5; 95% CI, 1.4-5; P < 0.001), current malignancy (HR, 2.0; 95% CI, 1.3-3.3; P = 0.011), postfilter anticoagulation (HR, 0.5; 95% CI, 0.28-0.9; P = 0.017), and history of pulmonary embolism and/or venous thromboembolism (HR, 0.5; 95% CI, 0.28-0.35; P < 0.001). Filter placement team and indication were not identified as independent predictors of nonretrieval of IVC filters. CONCLUSIONS: Patient variables identified by univariate and multivariate analyses as risk for nonretrieval of retrievable IVC filters have several implications: first, some of these patients may represent a group of patients with a low life expectancy or unresolvable underlying condition in which filter retrieval has diminishing returns and may indicate the clinical option for permanence of the filter; second, identification of risk factors for nonretrieval in patients before filter placement will help to optimize use of retrievable IVC filters and enhance retrieval rates.