Comparison Study of Iliac Branch Endoprosthesis when Used on and off Label.

BACKGROUND: The aim of this study is to compare how instructions for use (IFU) affected perioperative and intermediate term outcomes for common iliac artery aneurysms (CIAA) treated with the Gore Excluder iliac branch endoprosthesis (IBE). METHODS: A retrospective analysis was performed of all patients treated at two affiliated academic centers from September 2016 to May 2020. Outcomes were compared between IFU and nonIFU IBE cases. Criteria for nonIFU included: (1) use with a nonGore aortic endoprosthesis (n = 10), (2) isolated IBE (n = 3), and (3) requiring nondedicated covered stents for additional extension into a more suitable landing zone in the ipsilateral internal iliac artery or one of its branches (n = 11). Perioperative and intermediate term data were collected for both groups. The primary end points were free from the major adverse event (MAE) at 30 days and primary effectiveness at 1 year. RESULTS: A total of 51 CIAA (39 patients) were treated with an IBE. Overall, 15 patients were treated under IFU and 24 under nonIFU. The IFU group mean age was older (72 vs. 67 years, P = 0.03), and males (97%) were primarily treated. Comorbidities were similar except nonIFU had more patients with previous endovascular abdominal aortic aneurysm repair on presentation (0 vs. 4 cases, P = 0.04). Procedure (178 vs. 264 min, P = 0.02) and fluoroscopy (52 vs. 74 min, P = 0.04) times were longer in the nonIFU group. Technical success was 100% for both groups, and there was no difference in device related reintervention at 30 days (0 vs. 1, P = 0.44). There was no MAE in either group at 30 days. Intervention for any endoleak was similar between the groups (2 vs. 3, P = 0.94). Percent CIAA sac regression was similar between the groups (19% vs. 18%, P = 0.21). There was no difference for primary effectiveness at 1 year (93% vs. 92%, P = 0.85). There was one death per group at one year not related to an aortic or iliac cause. CONCLUSIONS: In properly selected patients with complex anatomy, IBE can be used with nondedicated aortic and internal iliac components with good early term outcomes.

Iliac Artery Endoconduits Should be the Preferred Adjunctive Access Procedure to Facilitate Complex Endovascular Aortic Aneurysm Repair.

BACKGROUND: Iliac artery anatomy can have a dramatic impact on the success of endovascular complex aortic aneurysm (CAA) procedures as endograft delivery systems need to be advanced and manipulated through these access vessels. The aim of this study was to evaluate the outcomes of iliac artery conduits with emphasizes on open vs endovascular conduits performed to facilitate CAA endovascular repair. METHODS: All patients who had open or endovascular iliac conduits prior to endovascular CAA repair to treat thoracoabdominal, juxtarenal, or suprarenal aneurysms at the University of Colorado Hospital from January 2009 through January 2019 were included. Patients who presented with symptomatic or ruptured aortic aneurysms were excluded. Outcomes of interest included postoperative complications and mortality in patients undergoing iliac conduits. RESULTS: Twenty-seven patients with a total of 42 conduits were included in the study. The majority of patients (N = 15, 56%) were female and the average age was 72 ± 9 years. The calculated VQI cardiac index was .6% (range, .3%-.8%). Eighteen (43%) endovascular and 24 (57%) open iliac conduits were performed during the study period. Thirty (71%) conduits were performed in a staged fashion, while 12 (29%) were performed at the same time as endovascular CAA repair. The mean time between conduit and definitive aneurysm repair surgery was 130 ± 68 days in the endovascular and 107 ± 79 days in the open groups (P = .87). No aneurysm rupture occurred during the staging period in either group. The median follow-up for the entire cohort was 18 ± 22 months. The median length of hospital stay for patients undergoing endovascular and open ICs was 6 (ranging, 1-28 days) and 7 days (ranging, 3-18 days), respectively. Patients undergoing open conduits had significantly more complications than those undergoing endovascular conduit (endoconduit) creation. A total of 4 (15%) patients died within 30 days after aneurysm repair. Out of 23 survivors, 18 (78%) patients were discharged home, 4 (18%) patients were discharged to a skilled nursing facility, and 1 (4%) patient was discharged to an acute rehabilitation facility. No mortality difference based on type of conduit was found. CONCLUSIONS: Overall complication rate associated with creation of open iliac artery conduits is not negligible. Endoconduits, which carry less morbidity than open conduits, are preferred as a first-line adjunctive access procedure to facilitate complex endovascular aortic aneurysm repair.

Critical appraisal of the contemporary use of atherectomy to treat femoropopliteal atherosclerotic disease.

OBJECTIVE: Atherectomy has become increasingly used as an endovascular treatment of lower extremity atherosclerotic disease in the United States. However, concerns and controversies about its indications and outcomes exist. The goal of the present systematic review and meta-analysis was to investigate the outcomes and complications related to atherectomy to treat femoropopliteal atherosclerotic disease. METHODS: A systematic review in accordance with the recommendations from the PRISMA (preferred reporting items for systematic reviews and meta-analyses) statement was performed. Four major scientific repositories (MEDLINE, Embase, the Cochrane Library, and Thompson Web of Sciences) were queried from their inception to April 5, 2020. We reviewed and entered the data in a dedicated dataset. The outcomes included the patency rates, clinical and hemodynamic improvement, and morbidity and mortality associated with atherectomy interventions. RESULTS: Twenty-four studies encompassing 1900 patients met the inclusion criteria for the present study. Of the 1900 patients, 74.3% had presented with Rutherford class 1 to 3 and 25.7% presented with Rutherford class 4 to 6; 1445 patients had undergone atherectomy, and 455 patients had been treated without atherectomy. The atherectomy group had undergone directional atherectomy (n = 851), rotational atherectomy (n = 851), laser atherectomy (n = 201), and orbital atherectomy (n = 78). Most of these patients had also received adjunct treatments, which varied across the studies and included a combination of stenting, balloon angioplasty, or drug-coated balloon angioplasty. Technical success was achieved in 92.3% of the cases. Distal embolization, vessel perforation, and dissection occurred in 3.4%, 1.9%, and 4% of the cases, respectively. The initial patency was 95.4%. At the 12-month median follow-up, the primary patency was 72.6%. The ankle brachial index had improved from a preoperative mean of 0.6 to a postoperative mean of 0.84. The incidence of major amputation and mortality during the follow-up period was 2.2% and 3.4%, respectively. CONCLUSIONS: The results from our review of the reported data suggest that femoropopliteal atherectomy can be completed safely, modestly improving the ankle brachial index and maintaining the 1-year patency in nearly three of four patients. However, these findings were based on heterogeneous studies that skewed the generalizable conclusions about atherectomy's efficacy. Atherectomy places a high cost burden on the healthcare system and is used in the United States at a higher rate than in other countries. Our review of the literature did not demonstrate clear atherectomy superiority to alternatives that would warrant the pervasive and increasing use of this costly technology. Future work should focus on developing high-quality randomized controlled trials to determine the specific patient and lesion characteristics for which atherectomy can add value.

A systematic review and meta-analysis of outcomes after acute limb ischemia in patients with cancer.

BACKGROUND: Cancer results in a hypercoagulable state that is associated with both venous and arterial thromboses. However, little is known about the effects of acute limb ischemia (ALI) in this cohort of patients. In the present systematic review and meta-analysis, we analyzed the available clinical data on cancer and its association with ALI and evaluated the outcomes in these patients after a diagnosis of ALI. METHODS: Three databases, including PubMed, EMBASE, and the Cochrane Library, were queried. Studies that met the inclusion criteria were included regardless of the publication year, language, sample size, or follow-up length. All the steps of the meta-analysis were conducted in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) and MOOSE (meta-analysis of observational studies in epidemiology) guidelines. RESULTS: Seven studies from 6222 references with a total of 2899 patients were included. Of the 2899 patients, 1195 (41%) had had a diagnosis of ALI before their cancer diagnosis, and 1704 (59%) had presented with ALI after a cancer diagnosis. Nearly three quarters of ALI events were among patients with cancer of the skin and soft tissue (19%), genitourinary (18%), lung (17%), and gastrointestinal (16%) systems. ALI recurrence was similar between the two groups, and major amputation was more likely in patients with a diagnosis of ALI after a cancer diagnosis (7.4% vs 4.6%; P < .01). The incidence of mortality at 1 year was significantly greater for patients with established cancer who had presented with ALI compared with the patients who had presented with ALI before a cancer diagnosis (50.6% vs 29.9%; P < .01). After adjusting for study variability using the random effects model, the mortality at 1 year for all patients was 52.3% (95% confidence interval, 37.7%-66.5%). No significant heterogeneity (P = .73) was found between the two groups of patients, which varied by the timing of the ALI diagnosis in relation to the cancer diagnosis. CONCLUSIONS: The 1-year mortality after the development of ALI in patients with cancer was >50%. For patients presenting with ALI of unclear etiology, the presence of an underlying cancer should be considered.

Iliac Conduits for Endovascular Treatment of Aortic Pathologies: A Systematic Review and Meta-analysis.

PURPOSE: The treatment of thoracoabdominal aortic aneurysm has largely shifted to endovascular techniques. However, severe iliofemoral arterial disease often presents a challenge during these interventions. As a result, iliac conduits have been introduced to facilitate aortic endovascular therapy. The goal of the current study was to gauge utilization and to analyze iliac artery conduit outcomes to facilitate endovascular therapy to treat aortic pathologies. MATERIALS AND METHODS: A meta-analysis of 14 studies was conducted with the use of random effects modeling. The incidence of periprocedural adverse events was gauged based on iliac conduit vs nonconduit cases and planned vs unplanned iliac conduit placement. Outcomes of interest included length of hospital stay, morbidity and mortality associated to conduits, and all-cause mortality. RESULTS: Iliac conduits, either open or endo-conduits, were utilized in 17% (95% CI: 9%-27%) of 16,855 cases, with technical successful rate of 94% (95% CI: 80%-100%). Periprocedural complications occurred in 32% (95% CI: 22%-42%) of the cases, with overall bleeding complication rate being 10% (95% CI: 5%-16%). Female patients, positive history for smoking, pulmonary disease, and peripheral artery disease at baseline were associated with more frequent utilization of iliac conduits. Conduit use was associated with longer hospitalization, higher periprocedural all-cause mortality (OR: 2.85; 95% CI: 1.75-4.64; p<0.001), and bleeding complication rate (OR: 2.38; 95% CI: 1.58-3.58; p<0.001). Sensitivity analysis among conduit cases showed that planned conduits were associated with fewer periprocedural complications compared to unplanned conduits (OR: 0.38; 95% CI: 0.20-0.73; p=0.004). CONCLUSION: Iliac conduit placement is a feasible strategy, associated with high technical success to facilitate complex aortic endovascular repair. However, periprocedural adverse event rate, including bleeding complications is not negligible. All-cause mortality and morbidity rates among cases that require iliac conduits should be strongly considered during clinical decision making. High-quality comparative analyses between iliac conduit vs nonconduit cases and between several types of iliac conduit grafts aiming at facilitating endovascular aortic repair are still needed to determine the best strategy to address challenging iliac artery accesses.

Exercise Training and Revascularization in the Management of Symptomatic Peripheral Artery Disease.

Exercise therapy and lower extremity revascularization both improve walking performance in symptomatic patients with peripheral artery disease. The combination of therapies provides greater benefit than either alone and may reduce the need for subsequent revascularization procedures, but further trials with longer follow-up are needed for the outcome of subsequent revascularization.

Sharp Recanalization with the Upstream GoBack Catheter for Chronic Occlusive Ilio-Caval Thrombosis.

Recanalization of chronic iliofemoral deep vein thrombosis is indicated to reduce symptoms and improve quality of life. However, recanalization is dependent on the ability to cross chronic obstructions. We present a case of chronically thrombosed inferior vena cava and common iliac veins that failed conventional crossing techniques but were successfully recanalized using the recently approved Upstream GoBack Crossing Catheter.

Massive Pulmonary Embolism with Cardiac Arrest during Routine Tibial Bypass Surgery.

We report the case of a massive pulmonary embolism with intraoperative cardiac arrest in a 48-year-old male during routine surgical tibial bypass successfully managed by catheter-based interventions. Our experience supports the trending shift in pulmonary embolism therapy guidelines to include endovascular approaches and emphasizes the need for vascular surgeons to adapt their training protocols.

The utilization of intravascular lithotripsy to facilitate transcarotid artery revascularization.

Carotid artery disease and stroke account for the second cause of mortality in worldwide. Recently, transcarotid artery stenting (TCAR) has emerged as a treatment modality that carries a very low stroke rate. However, there are limitations to TCAR, such as heavily calcified plaques that might preclude optimal stent expansion. We describe a successful transcarotid artery stenting with flow reversal performed in an independent and active nonagenarian with focal, circumferentially calcified carotid artery plaque, for which intravascular lithotripsy was utilized.

A systematic review of diagnosis and treatment of acute limb ischemia during pregnancy and postpartum period.

BACKGROUND: Acute limb ischemia (ALI) carries significant overall morbidity and mortality. Pregnant and postpartum women are physiologically hypercoagulable, but little is known about the impact of ALI in this cohort of patients. The goal of this systematic review was to gather available data on diagnosis and treatment of ALI during pregnancy and the postpartum period. METHODS: A systematic review of studies on patients with ALI during pregnancy and the puerperium was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Three databases including PubMed MEDLINE, Embase, and Cochrane Library were queried. Manuscripts that provided data on diagnosis and treatment of ALI in pregnant and postpartum patients were included regardless of language or study design. Outcomes of interest included type of treatment for ALI (open and endovascular), morbidity, and mortality. RESULTS: Fourteen manuscripts of 6222 references were included with a total of 14 patients. The median age of patients was 31.5 years. Embolism, present in eight (57%) patients, was slightly more common than thrombosis. All patients had a pregnancy complication or concomitant medical condition that might have predisposed to arterial occlusion either directly or indirectly by leading to iatrogenic arterial injury; peripartum cardiomyopathy, the most common, occurred in six (43%) patients. Open surgery was the preferred treatment option in 11 (79%) patients, followed by anticoagulation alone. No endovascular procedures were described. One patient underwent major amputation on presentation, and an additional patient required major amputation for recurrent ALI. No deaths occurred. Twelve (86%) patients had complete recovery with no other ALI-associated sequelae. CONCLUSIONS: ALI is rare in pregnant and postpartum women despite their transient physiologic hypercoagulability and is almost uniformly associated with pregnancy complications. Open surgical revascularization or anticoagulation alone appears to have acceptable outcomes as most patients present with embolism or thrombosis without underlying systemic arterial disease.

Percutaneous Endovascular Repair of a Ruptured Extent III Thoracoabdominal Aortic Aneurysm with Bilateral Large Common Iliac Aneurysms and Aortocaval Fistula.

Ruptured thoracoabdominal aneurysms (rTAAAs) are rare and carry a significant rate of morbidity and mortality. Aortocaval fistula secondary to rTAAA is even more infrequent. We describe an urgent and staged endovascular treatment of a ruptured extent III thoracoabdominal aortic aneurysm with an aortocaval fistula by performing vena cava stenting to treat aortocaval fistula as a damage control maneuver prior to transfer and subsequent TAAA repair with a physician-modified endograft at a quaternary level hospital.

Stent-Graft Length Is Associated with Decreased Patency in Treatment of Central Venous Stenosis in Hemodialysis Patients.

BACKGROUND: Central venous occlusion may occur in hemodialysis patients, resulting in arm or facial swelling and failure of dialysis access. Endovascular management with balloon angioplasty or stenting has been described, but there are minimal data on the use of covered stents in this pathology. We sought to review a single institution's experience with the use of covered stents for central venous occlusive disease in hemodialysis patients. METHODS: A retrospective review of all patients undergoing placement of covered stents between April 2014 and December 2016 for central venous occlusive disease to preserve a failing dialysis access was performed. Patients' records were reviewed to identify demographics, medical comorbidities, operative variables, primary patency rates, and secondary interventions. RESULTS: A total of 29 patients were included in the analysis. Viabahn (W.L. Gore and Associates, Flagstaff, AZ) stent grafts were exclusively used in all patients. Technical success rate was 100%. The patients were predominantly female (65.5%), with a mean age of 67.9 ± 12.1 and medical comorbidities of hypertension (86%), diabetes (76%), and tobacco use (7%). The majority (86%) had prior angioplasty and 17 of 29 (59%) patients had previous central venous catheters. The right brachiocephalic vein was the most commonly stented vessel (28%). The median stent length and diameter used were 50 millimeters (range 25-100 millimeters) and 13 millimeters (range: 9-13 millimeters), respectively. The majority of patients (83%) received a single stent, with only 2 patients requiring more than one. Median follow-up was 24 months (range: 6-41 months). Four of 29 (13.8%) patients developed symptomatic stent restenosis requiring secondary intervention, all of which occurred in patients with primary stenosis between 50% and 75%. When compared to the patients without restenosis, longer stents were found to be significantly associated with restenosis (62.5 centimeters, interquartile range [IQR]: 0] vs. 50 centimeter, IQR: 0, P = 0.002). Primary patency rates were 92.9%, 91.7%, and 80.0% at 6, 12, and 24 months respectively. Secondary patency rates were 96.4%, 95.8%, and 93.3% at 6 months, 12 months, and 24 months, respectively. The overall primary patency rate was estimated at 86.2% using Kaplan-Meier analysis at 30.5 months (95% confidence interval: 26.5-34.5 months). CONCLUSIONS: Covered stent grafts have reasonable primary patency and excellent secondary patency when used for central venous stenosis in dialysis patients. Stent-graft length is associated with poorer long-term patency rates.

Massive Hemoptysis From an Aortobronchial Fistula Secondary to BCG-Related Mycotic Thoracic Aortic Aneurysm.

Intravesical bacillus Calmette-Guérin (BCG) is first-line therapy for noninvasive bladder cancer. Although side effects are rare, systemic dissemination can result in mycotic aneurysms. We report the case of a rapidly developing thoracic aortic mycotic aneurysm presenting as massive hemoptysis from an aortobronchial fistula. This case was unusual in its location, rapidity of development, and failure of medical therapy. The diagnostic challenges and the need for a high index of suspicion are discussed.

Stenting of femoropopliteal lesions using interwoven nitinol stents.

OBJECTIVE: The Supera stent (Abbott Laboratories, Abbott Park, Ill) has a unique biomimetic design allowing axial and longitudinal flexibility and fracture resistance. The aim of this retrospective study was to assess the midterm patency of Supera stents used to treat patients with superficial femoral and popliteal arterial disease by a single practice. METHODS: From April 2010 to December 2011, 53 patients and 59 limbs with symptomatic femoropopliteal lesions underwent angioplasty and stenting with the Supera stent. Five patients had no follow-up and were excluded. Demographics of the patients, radiographic images, morphologic features of the lesions, procedural reports, reinterventions, and follow-up clinical visit notes were reviewed. Primary patency was defined as clinical resolution of symptoms with no secondary interventions. Primary and secondary patency rates at 12, 24, and 36 months were estimated by Kaplan-Meier analysis. RESULTS: A total of 48 patients (42 men, six women; 54 limbs; mean age, 64.3 years [range, 51-87]) received Supera stents and had at least one follow-up visit as part of their treatment for femoropopliteal disease. Primary indications for intervention included claudication, rest pain, and tissue loss, at rates of 54% (29 of 54), 26% (14 of 54), and 20% (11 of 54), respectively; 22% of lesions were TransAtlantic Inter-Society Consensus type A or B and 78% were type C or D. Mean lesion length was 24.0 cm (range, 3-51). Mean follow-up was 27.5 months (range, 1-45). The ankle-brachial index increased from 0.58 ± 0.20 preoperatively to 0.77 ± 0.18 postoperatively (P = .00004). Primary, primary assisted, and secondary patency rates at latest follow-up were 79.6%, 88.9%, and 92.3%, respectively. Cumulative primary patency rates by Kaplan-Meier analysis at 12, 24, and 36 months were 85.6%, 83.1%, and 76.7%, respectively. Secondary patency rates by Kaplan-Meier estimates at 12, 24, and 36 months were 93.8%, 93.8%, and 89.3%, respectively. No stent fractures were found at the time of any reinterventions. Long lesions >30 cm (n = 18) showed equivalent patency to lesions of 1 to 15 cm (n = 18) and lesions 15 to 30 cm in length (n = 18). CONCLUSIONS: Our midterm results show that Supera stents are durable in treating femoropopliteal lesions, with notably high patency rates in patients with long lesion lengths.

Short-term outcomes of the C3 excluder for patients with abdominal aortic aneurysms and unfavorable proximal aortic seal zones.

BACKGROUND: Endovascular abdominal aortic aneurysm repair (EVAR) in patients with unfavorable proximal seal zones remains challenging. The purpose of this study was to identify the incidence of proximal extension cuff usage for type I endoleaks in patients with abdominal aortic aneurysms and unfavorable necks treated with the C3 Excluder repositionable endoprosthesis compared with the traditional Excluder stent-graft. METHODS: This is a retrospective review of patients undergoing EVAR with unfavorable neck anatomy from January 2010 to October 2011 using the Excluder endoprosthesis on the traditional deployment system or the C3 repositionable system. Seventy-seven patients were treated with the Excluder device, with 44 (57%) having unfavorable neck anatomy defined as proximal aortic neck length of <15 mm, neck diameter of >28 mm, neck angulation of >60°, circumferential thrombus of >50% or calcification at the proximal seal zone, or a "reverse taper" on computed tomographic angiography. Of the 44 patients with unfavorable neck anatomy, 24 patients received the C3 Excluder and 20 received the traditional Excluder. RESULTS: The groups' comorbidities, aneurysm characteristics, and high-risk neck criteria were comparable. Initial success was 100% in both groups. Sixteen of the 44 patients (36%) with high-risk neck criteria required proximal extension cuffs for type I endoleaks, with 3 of the 24 patients (13%) in the C3 group compared with 13 of the 20 patients (65%) in the traditional Excluder group requiring proximal extension (P = 0.0005). Operative variables between the two groups were similar. At mean follow-up of 2 months (range: 1-6 months), there were no type I endoleaks or renal artery occlusion, and sac size regression was similar. CONCLUSIONS: The C3 Excluder endoprosthesis significantly reduces the need for proximal extension cuffs in patients with unfavorable aortic neck anatomy compared with the traditional Excluder with identical short-term clinical outcomes. Repositionable grafts could increase the number of patients who can effectively be treated with EVAR.

Endovascular repair of a para-anastomotic pseudoaneurysm after renal autotransplantation: an alternative to open reconstruction.

Renal artery anastomotic pseudoaneurysms are rare after renal transplantation. The etiology tends to be technical, infectious, or degenerative, and repair is difficult with a high postsurgical complication rate. We report the first case of a complex autotransplant renal artery pseudoaneurysm repaired with kissing covered stents. A 52-year-old woman presented with severe left lower quadrant abdominal pain 6 years after a renal autotransplant for ureteral stenosis and recurrent pyelonephritis. A computed tomographic angiography (CTA) scan revealed a bilobed aneurysm arising at the anastomosis between the renal and common iliac arteries. Kissing covered stents were placed within the common iliac artery proximally and extending into the transplant renal artery and external iliac artery. Postdeployment angiography confirmed complete exclusion of the pseudoaneurysm and excellent flow into the transplant kidney and left lower extremity. A follow-up CTA scan at 1 month revealed continued stent-graft patency and complete exclusion of the pseudoaneurysm. An endovascular approach to transplant anastomotic pseduoaneurysms using kissing covered stents is a viable option to exclude aneurysmal changes and preserve flow to the transplanted organ in carefully selected patients.

Treatment of chronic venous stent occlusion with a Wildcat catheter.

A 47-year-old female with an occluded iliac vein stent originally placed for deep venous thrombosis and May-Thurner syndrome presented to our clinic with complaints of left lower extremity pain and swelling. Multiple previous attempts had been made to cross this lesion with guidewire and catheter techniques without success. We were able to cross the lesion with the Wildcat catheter. Subsequent directional laser atherectomy and balloon angioplasty followed by stent placement resulted in a patent stent and resolution of her symptoms. This is the first reported use of the Wildcat catheter in chronic venous stent occlusions.