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.

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.

Prophylactic Inferior Vena Cava Filter Utilization and Risk Factors for Nonretrieval.

PURPOSE: Inferior vena cava filters (IVCFs) are often placed for prophylactic indications. We sought to better define the range of practice indications for placement of prophylactic IVCFs, as well as the specific retrieval rate and risk factors for nonretrieval. METHODS: A retrospective, single-institution review of patients undergoing IVCF placement over a 2-year period was performed. Patients undergoing prophylactic IVCF placement were selected from a prospectively collected database. Risk factors for nonretrieval were identified using a multivariate logistic regression model. RESULTS: Of 615 IVCFs placed, 256 were retrievable filters placed for prophylactic indications and comprised the study cohort. The most common indications were a history of venous thromboembolic disease (43.7%), malignancy (35.1%), bleeding risk precluding anticoagulation (33.9%), and trauma (22.6%). One hundred sixty-three (63.6%) were placed preoperatively. Placement was performed in 70.3% by interventional radiology, 21.4% by vascular surgery, and 8.2% by cardiology. The most common requesting services were orthopedics (67%), general surgery (11%), neurosurgery (9%), and bariatric surgery (7%). Of all, 67.6% were placed in the inpatient setting and 32.4% in outpatients. Seventy-one (27.7%) of the 256 prophylactic filters were retrieved, with a mean indwelling time of 92 ± 74 days. Inpatients were significantly less likely to have their IVCF removed (32.4% vs 57.8%; P < .001), as were preoperative patients. CONCLUSIONS: This study helps define current practice trends for the placement of prophylactic IVCFs. Importantly, the specific retrieval rate for prophylactic filters is low. This suggests that prophylactic IVCF usage is suboptimal and efforts should be taken to increase retrieval, especially among inpatients and perioperative patients.

Transradial Delivery of a Renal Snorkel During Complex Endovascular Aortic Aneurysm Repair.

Transradial access has been described in a variety of clinical contexts but has been rarely utilized for visceral artery interventions and during complex endovascular aortic aneurysm repair (EVAR) when upper extremity access is required. This is usually accomplished via brachial artery access, and although brachial access is generally safe and effective, radial access may offer some benefits with regard to patient comfort and potential complications. Here we report a case of successful delivery of a renal snorkel via a radial artery approach during EVAR. A 71-year-old man presented for endovascular repair of an asymptomatic abdominal aortic aneurysm. Anatomic limitations dictated the need for a left renal snorkel in order to augment the proximal seal zone. Via a right radial approach, a 6-Fr sheath and then a 6-mm iCast stent (Atrium Medical, Hudson, New Hampshire) were delivered into the left renal artery. Endovascular aortic aneurysm repair was then completed with a bifurcated Endurant stent graft (Medtronic, Fridley, Minnesota). The renal stent and aortic stent grafts were successfully deployed. Completion angiography demonstrated a patent left renal snorkel, with no evidence of endoleak. Hemostasis was achieved at the radial puncture site with no complications. This demonstrates the feasibility of radial artery access for the delivery of adjunctive stents during complex EVAR.

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.

Cervical-petrous internal carotid artery pseudoaneurysm presenting with otorrhagia treated with endovascular techniques.

Cervical-petrous internal carotid artery (CP-ICA) pseudoaneurysms are rare and have different etiologies, presentations, and treatment options. A middle-aged patient with a history of chronic otitis media presented with acute otorrhagia and was found to have a left-sided CP-ICA pseudoaneurysm. The patient was a poor surgical candidate with difficult arterial access. The pseudoaneurysm was treated with stand-alone coiling via a left brachial approach with persistent contrast filling seen only in the aneurysm neck at the end of the procedure. The patient re-presented 12 days later with repeat hemorrhage and rapid enlargement of the neck remnant, and was treated with a covered stent via a transcervical common carotid artery cut-down. A covered stent may provide a more definitive treatment for CP-ICA pseudoaneurysms compared with standalone coiling.

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.

Cervical-petrous internal carotid artery pseudoaneurysm presenting with otorrhagia treated with endovascular techniques.

Cervical-petrous internal carotid artery (CP-ICA) pseudoaneurysms are rare and have different etiologies, presentations, and treatment options. A middle-aged patient with a history of chronic otitis media presented with acute otorrhagia and was found to have a left-sided CP-ICA pseudoaneurysm. The patient was a poor surgical candidate with difficult arterial access. The pseudoaneurysm was treated with stand-alone coiling via a left brachial approach with persistent contrast filling seen only in the aneurysm neck at the end of the procedure. The patient re-presented 12 days later with repeat hemorrhage and rapid enlargement of the neck remnant, and was treated with a covered stent via a transcervical common carotid artery cut-down. A covered stent may provide a more definitive treatment for CP-ICA pseudoaneurysms compared with standalone coiling.

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.

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.

Anatomic risk factors for type-2 endoleak following EVAR: a retrospective review of preoperative CT angiography in 326 patients.

PURPOSE: We describe the anatomic characteristics on preoperative CT angiography (CTA) that predispose to type-2 endoleaks after endovascular aneurysm repair (EVAR) for an abdominal aortic aneurysms (AAA). METHODS: Between 1999 and 2010, 326 patients had a CTA before and after EVAR. CTAs were reviewed for maximal sac diameter, >50% circumferential luminal thrombus, and patency of the infrarenal aortic side branches, including the inferior mesenteric artery (IMA) and L2-L5 lumbar arteries. Postoperative CTAs were reviewed for a persistent type-2 endoleak. RESULTS: Of 326 patients, 30.4% had a type-2 endoleak on CTA. Univariate analysis demonstrated a patent IMA, increased patent individual L2, L3, and L4 lumbar arteries, and an increased number of total patent lumbar arteries in patients with type-2 endoleak compared to those without (p < 0.001, 0.002, <0.001, <0.001, and <0.001 respectively). Sac diameter, patent L5 lumbar arteries, and >50% circumferential mural thrombus were not significantly different (p = 0.652, 0.617, and 0.16). Univariate logistic regression demonstrated increased risk of endoleak with each additional patent lumbar artery (odds ratio (OR) 1.26, p < 0.001). Multivariate analysis of the 326 patients resulted in the delineation of the optimal anatomic variables that predicted a type-2 endoleak: occluded L3 lumbar arteries (OR 0.1, p = 0.002), occluded L4 lumbar vertebral arteries (OR 0.31, p = 0.034), and IMA occlusion (OR 0.38, p = 0.008). CONCLUSIONS: Univariate analysis demonstrated total patent lumbar arteries as a significant predictor of type-2 endoleak. Multivariate analysis demonstrated IMA occlusion, L3 lumbar artery occlusion, and L4 lumbar artery occlusion as independently protective against type-2 endoleak after EVAR.

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.

Emergency valve re-replacement for embolization of prosthetic mitral valve disc during catheterization procedure.

A 47-year-old woman with a mechanical mitral valve underwent a catheter-based atrial fibrillation ablation procedure, which was complicated by the dislodgment and immediate embolization of one of the valve leaflets. Acute severe mitral regurgitation and cardiogenic shock developed, necessitating emergency reoperative mitral valve re-replacement. She subsequently underwent a successful staged retrieval of the embolized leaflet from the abdominal aorta.

Stent graft repair of paraanastomotic aneurysms after open descending thoracic and thoracoabdominal aortic aneurysm repair.

BACKGROUND: After open thoracic and thoracoabdominal aortic aneurysm repair, anastomotic aneurysms can form at or near the suture lines of the graft. Endovascular repair is an alternative to complicated reoperative open surgery. We report on our experience with endovascular treatment of these lesions. METHODS: A prospectively maintained database of endovascular thoracic aortic aneurysm repairs (TEVARs) performed at Mount Sinai Medical Center was reviewed and the initial procedures, comorbidities, clinical presentation, aneurysm characteristics, type of endograft, adjunctive procedures, and follow-up were analyzed. RESULTS: Of the 135 TEVAR procedures performed between June 2001 and December 2008, 9 patients had anastomotic aneurysms after a previous open repair. The mean age was 66.7 (range 41-89) years, 67% of whom were male. Of these 9 patients, 5 had a descending thoracic repair, 3 had a type IV repair, and 1 had a type II thoracoabdominal repair. Aneurysm formation occurred in the following regions: proximal anastomosis (n = 2); intercostal patch (n = 1); distal anastomosis (n = 3); visceral patch (n = 2); and midgraft (n = 1). The initial technical success rate was 100%, with 8 patients receiving a thoracic tube graft and 1 a modular bifurcated device. Two patients required an adjunctive carotid-subclavian bypass and 2 required extraanatomic revascularization of the visceral arteries. Mean follow-up was 16.5 months. There was 1 perioperative death secondary to a postoperative myocardial infarction. Three patients developed an endoleak with 1 requiring an intervention. One patient required an open thoracoabdominal repair at 3 months for a penetrating ulcer at the visceral segment and another died from a ruptured thoracic aneurysm proximal to the stent graft at 72 months. Two more died during the follow-up period of non-aneurysm-related causes. Five patients had paraanastomotic shrinkage or no change and 1 had an increase in size, and 3 had no follow-up imaging. CONCLUSIONS: Stent graft repair of paraanastomotic aneurysms after open descending thoracic and thoracoabdomninal repair is a reasonable option when patients have suitable anatomy. These patients, however, require close follow-up for the development of aneurysmal degeneration adjacent to the stent graft repair.