Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System.

BACKGROUND: An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths. METHODS: The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure. RESULTS: A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88). CONCLUSIONS: In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558.

Impact of COVID-19 on patients undergoing scheduled procedures for chronic venous disease.

OBJECTIVE: The COVID-19 pandemic has drastically altered the medical landscape. Various strategies have been employed to preserve hospital beds, personal protective equipment, and other resources to accommodate the surges of COVID-19 positive patients, hospital overcapacities, and staffing shortages. This has had a dramatic effect on vascular surgical practice. The objective of this study is to analyze the impact of the COVID-19 pandemic on surgical delays and adverse outcomes for patients with chronic venous disease scheduled to undergo elective operations. METHODS: The Vascular Surgery COVID-19 Collaborative (VASCC) was founded in March 2020 to evaluate the outcomes of patients with vascular disease whose operations were delayed. Modules were developed by vascular surgeon working groups and tested before implementation. A data analysis of outcomes of patients with chronic venous disease whose surgeries were postponed during the COVID-19 pandemic from March 2020 through February 2021 was performed for this study. RESULTS: A total of 150 patients from 12 institutions in the United States were included in the study. Indications for venous intervention were: 85.3% varicose veins, 10.7% varicose veins with venous ulceration, and 4.0% lipodermatosclerosis. One hundred two surgeries had successfully been completed at the time of data entry. The average length of the delay was 91 days, with a median of 78 days. Delays for venous ulceration procedures ranged from 38 to 208 days. No patients required an emergent intervention due to their venous disease, and no patients experienced major adverse events following their delayed surgeries. CONCLUSIONS: Interventions may be safely delayed for patients with venous disease requiring elective surgical intervention during the COVID-19 pandemic. This finding supports the American College of Surgeons' recommendations for the management of elective vascular surgical procedures. Office-based labs may be safe locations for continued treatment when resources are limited. Although the interventions can be safely postponed, the negative impact on quality of life warrants further investigation.

Multidisciplinary diagnosis and management of inflammatory aortic aneurysms.

BACKGROUND: Inflammatory abdominal aortic aneurysms (IAAAs) are a variant involving a distinct immunoinflammatory process, with nearly one half believed to be associated with IgG4-related disease (IgG4-RD). METHODS: MEDLINE and Google Scholar searches were conducted for English-language publications relevant to inflammatory aortic aneurysms from January 1970 onward. The search terms included inflammatory aortic aneurysms, aortitis, periaortitis, IgG4-related disease, and retroperitoneal fibrosis. Relevant studies were selected for review based on their relevance. RESULTS: Morphologically, IAAAs are characterized by a thickened aneurysm wall often displaying contrast enhancement and elevated metabolic activity on fluorine-18 fluorodeoxyglucose-positron emission tomography imaging. A strong association exists with perianeurysmal and retroperitoneal fibrosis. Although the rupture risk appears lower with IAAAs than with noninflammatory abdominal aortic aneurysms (AAAs), the currently recommended diameter threshold for operative management is the same. Open repair has been associated with increased morbidity compared with noninflammatory AAAs, and a retroperitoneal approach or minimal dissection transperitoneal approach has been recommended to avoid duodenal and retroperitoneal structural injuries. Endovascular aneurysm repair has been increasingly used, especially for patients unfit for open surgery. It is important to exclude an infectious etiology before the initiation of immunosuppressive therapy or operative repair. Multimodality imaging follow-up is critical to monitor disease activity and secondary involvement of retroperitoneal structures by the associated fibrotic process. Maintenance of immunosuppressive therapy will be needed postoperatively for most patients with active systemic disease, especially those with IgG4-RD and those with persistent symptoms. Additional interventions aimed at ureteral decompression could also be required, and lifelong follow-up is mandatory. CONCLUSIONS: Preoperative multimodality imaging is a diagnostic cornerstone for assessment of the disease extent and activity. IgG4-RD is an increasingly recognized category of IAAAs, with implications for tailoring adjunctive medical therapy. Open surgical repair remains the procedure of choice, although endovascular aneurysm repair is increasingly being offered. Maintenance immunosuppressive therapy can be offered according to the disease activity as assessed by follow-up imaging studies.

Renal Artery Stenosis due to Entrapment.

BACKGROUND: Common etiologies of renovascular occlusive disease include atherosclerosis disease, developmental fibrotic conditions such as fibromuscular dysplasia, and vasculitis. Extrinsic compression of the renal artery is a rarely reported phenomenon but can lead to similar clinical manifestations. METHODS: We report recent experience with 2 patients who presented with extrinsic renal artery compression due to entrapment. Diagnosis was made with a constellation of findings on computed tomography angiography, dynamic duplex sonography, and catheter angiography. Both patients had hypertension and 1 had downstream subsegmental renal infarcts. The patients, both with right-sided renal artery entrapment, were treated with open surgical decompression. Exposure was achieved via extended Kocher maneuver followed by mobilization of the right kidney and, in 1 patient, detachment of the right lobe of liver to allow circumferential exposure of the proximal right renal artery to the aorta. All entrapping tissue was circumferentially released. RESULTS: Both operations were uncomplicated. Intraoperative sonography was used to confirm luminal patency of the released segments. Follow-up of renal artery duplex in both patients demonstrated resolution of dynamic compression. Renal artery peak systolic velocity and accelerations indices were all within normal limits. In both patients, improvement in blood pressure control was noted and discontinuation of anticoagulation was possible in the patient who had recurrent episodes of renal infarct. CONCLUSIONS: Extrinsic compression of renal artery by diaphragmatic crura is rare but should be considered in younger patients or otherwise any patients with no vascular risk factors when renovascular hypertension workup yields no demonstrable intrinsic disease. A high index of suspicion should be raised when an anomalously high origin of the renal artery or proximity to the diaphragmatic crura is seen on cross-sectional imaging. Work-up should include dynamic imaging to assess compression of renal arteries during expiration. Open surgical or laparoscopic decompression of the involved renal arteries can be curative.

One-year results with a low-profile endograft in subjects with thoracic aortic aneurysm and ulcer pathologies.

OBJECTIVE: The study objective was to evaluate the safety and effectiveness of the second-generation, low-profile RelayPro (Terumo Aortic) thoracic endograft for the treatment of descending thoracic aortic aneurysm or penetrating atherosclerotic ulcer. METHOD: A prospective, international, nonblinded, nonrandomized, pivotal trial analyzed a primary safety end point of major adverse events at 30 days (death, myocardial infarction, stroke, renal/respiratory failure, paralysis, bowel ischemia, procedural blood loss) and a primary effectiveness end point of treatment success at 1 year (technical success, patency, absence of aneurysm rupture, type I/III endoleaks, stent fractures, reinterventions, aneurysm expansion, and migration) compared with performance goals from the previous generation Relay pivotal study. The study was conducted in 36 centers in the United States and Japan and enrolled participants between 2017 and 2019. RESULTS: The study population of 110 patients had a median (interquartile range) age of 76 (70-81) years, 69 (62.7%) were male, and 43 (39.1%) were Asian. Patients were treated for 76 fusiform aneurysms (69%), 24 saccular aneurysms (22%), and 10 penetrating atherosclerotic ulcers (9%). Most patients (82.7%) were treated with a non-bare stent configuration. Technical success was 100%. The median (interquartile range) procedure time was 91 (64-131) minutes, and the deployment time was 16 (10-25) minutes. A total of 50 patients (73.5%) in the US cohort had percutaneous access, whereas centers in Japan used only surgical cutdown. The 30-day composite major adverse events rate was 6.4% (95% upper confidence interval, 11.6%; P = .0002): 2 strokes, 2 procedural blood losses greater than 1000 mL requiring transfusion, 2 paralysis events, and 1 renal failure. Primary effectiveness was 89.2% (lower 95% confidence interval, 81.8%; P = .0185). Nine subjects experienced 11 events (1 aneurysm expansion, 6 secondary interventions, and 4 type I endoleaks). There was no loss of stent-graft patency, no rupture, no fractures, and no migration. CONCLUSIONS: The low-profile RelayPro thoracic endograft met the study primary end points and demonstrated satisfactory 30-day safety and 1-year effectiveness for the treatment of patients with aneurysms of the descending thoracic aorta or penetrating atherosclerotic ulcers. Follow-up is ongoing to evaluate longer-term outcomes and durability.

The Use of Cangrelor Infusions After Endovascular Aortic Repair With Prophylactic Lumbar Drain Placement.

Perioperative lumbar drains commonly are placed for spinal cord protection in patients undergoing endovascular aortic repair. However, the logistics of postoperative neuraxial drain removal is challenging in the presence of systemic antithrombotic therapy. This retrospective case series describes the novel use of cangrelor infusions in this high-risk setting. All lumbar drains were placed preoperatively, and descriptive data were collected including cangrelor infusion duration, time to lumbar drain removal after the infusion discontinuation, clinical course, and overall patient outcomes. There were no neurologic complications associated with lumbar drain insertion or removal, and median time to lumbar drain removal was 150 minutes after cangrelor infusion discontinuation. While further study is needed to validate its efficacy and safety, this case series highlights the promise of cangrelor infusions for systemic antithrombotic therapy in the cardiovascular/surgical intensive care unit.

Endovascular Repair of Ascending Aortic Pseudoaneurysm Using Transfemoral Frame-Coiling Under Total Cerebral Protection.

Ascending aortic pseudoaneurysms are associated with prior cardiac surgery and have a high chance of rupture. Open surgery is challenging given its likely reoperative nature. Various endovascular therapies have been described but are sometimes complicated by stroke. We present a patient with a prior coronary artery bypass grafting who was referred for an incidental 3-cm saccular ascending aortic pseudoaneurysm who was successfully treated with frame coiling under total cerebral embolic protection using the SENTINEL device. We propose that endovascular obliteration of ascending aortic pseudoaneurysms is a viable option in patients unfit for open repair and advocate for total cerebral embolic protection as an important adjunct.

Safety and effectiveness of the TREO stent graft for the endovascular treatment of abdominal aortic aneurysms.

OBJECTIVE: The short- and mid-term outcomes of endovascular aortic aneurysm repair have made it a standard treatment of abdominal aortic aneurysms. However, newer generation devices have yet to demonstrate improved long-term rates for complications, reinterventions, and survival. The TREO stent graft is a latest generation device and was evaluated for approval in the United States. METHODS: In a multicenter, nonrandomized, investigational device exemption clinical trial, we assessed the safety and effectiveness of the TREO device, with core laboratory assessment of the imaging studies and an independent adjudication of safety. The primary effectiveness endpoint was successful aneurysm treatment at 1 year. The primary safety endpoint was the incidence of major adverse events (MAE) at 30 days. RESULTS: A total of 150 patients (132 men; 88.0%) with infrarenal abdominal aortic (87.3%) or aortoiliac (12.7%) aneurysms were enrolled. The data were normally distributed. The mean age was 71.7 ± 7.4 years. The MAE incidence at 30 days was 0.7%. One subject experienced two MAE: myocardial infarction and procedural blood loss of 1000 mL. The proportion of successful aneurysm treatment at 1 year was 93.1%. Longer term follow-up continues, with no aneurysm-related mortality at the latest follow-up. At 3 years, the cumulative all-cause mortality and incidence of type I and type III endoleaks was 10.7% (n = 16), 2.7% (n = 4), and 0% (n = 0), respectively. In addition, aneurysm sac shrinkage >5 mm at 3 years had occurred in 54.3% of patients, and 9.3% had required a secondary intervention (n = 14). CONCLUSIONS: The safety and effectiveness of endovascular repair of abdominal aneurysms with TREO were demonstrated, with 93.1% successful aneurysm treatment at 1 year and aneurysm sac shrinkage >5 mm at 3 years in 54.3% of patients. Long-term follow-up continues to determine whether these favorable outcomes will be sustained.

The Effect of Improving Basic Preventive Measures in the Perioperative Arena on Staphylococcus aureus Transmission and Surgical Site Infections: A Randomized Clinical Trial.

Importance: Surgical site infections increase patient morbidity and health care costs. The Centers for Disease Control and Prevention emphasize improved basic preventive measures to reduce bacterial transmission and infections among patients undergoing surgery. Objective: To assess whether improved basic preventive measures can reduce perioperative Staphylococcus aureus transmission and surgical site infections. Design, Setting, and Participants: This randomized clinical trial was conducted from September 20, 2018, to September 20, 2019, among 19 surgeons and their 236 associated patients at a major academic medical center with a 60-day follow-up period. Participants were a random sample of adult patients undergoing orthopedic total joint, orthopedic spine, oncologic gynecological, thoracic, general, colorectal, open vascular, plastic, or open urological surgery requiring general or regional anesthesia. Surgeons and their associated patients were randomized 1:1 via a random number generator to treatment group or to usual care. Observers were masked to patient groupings during assessment of outcome measures. Interventions: Sustained improvements in perioperative hand hygiene, vascular care, environmental cleaning, and patient decolonization efforts. Main Outcomes and Measures: Perioperative S aureus transmission assessed by the number of isolates transmitted and the incidence of transmission among patient care units (primary) and the incidence of surgical site infections (secondary). Results: Of 236 patients (156 [66.1%] women; mean [SD] age, 57 [15] years), 106 (44.9%) and 130 (55.1%) were allocated to the treatment and control groups, respectively, received the intended treatment, and were analyzed for the primary outcome. Compared with the control group, the treatment group had a reduced mean (SD) number of transmitted perioperative S aureus isolates (1.25 [2.11] vs 0.47 [1.13]; P = .002). Treatment reduced the incidence of S aureus transmission (incidence risk ratio; 0.56; 95% CI, 0.37-0.86; P = .008; with robust variance clustering by surgeon: 95% CI, 0.42-0.76; P < .001). Overall, 11 patients (4.7%) experienced surgical site infections, 10 (7.7%) in the control group and 1 (0.9%) in the treatment group. Transmission was associated with an increased risk of surgical site infection (8 of 73 patients [11.0%] with transmission vs 3 of 163 [1.8%] without; risk ratio, 5.95; 95% CI, 1.62-21.86; P = .007). Treatment reduced the risk of surgical site infection (hazard ratio, 0.12; 95% CI, 0.02-0.92; P = .04; with clustering by surgeon: 95% CI, 0.03-0.51; P = .004). Conclusions and Relevance: Improved basic preventive measures in the perioperative arena can reduce S aureus transmission and surgical site infections. Trial Registration: ClinicalTrials.gov Identifier: NCT03638947.

Innominate to contralateral brachial artery bypass via ministernotomy with anatomic tunneling for critical ischemia of the left upper extremity.

OBJECTIVES: Scarring from prior bypass surgery and irradiation may compromise revascularization options in critical ischemia due to underlying occlusive disease. Occlusive disease of the axillo-brachial artery is particularly difficult to revascularize under such hostile conditions. METHOD: We present a case of a 58-year-old woman presenting with a painful, pulseless, and cool left upper extremity. The patient had a known history of left upper extremity occlusive disease which was managed by subclavian-axillary artery stenting with re-occlusion and subsequent extra-anatomic left carotid-to-proximal brachial artery prosthetic bypass, which was complicated by stroke. The patient had a history of left mastectomy, axillary node dissection, and external beam radiation therapy. When considering revascularization options, the combination of post-radiation changes and scarring of the conventional operative zones for revascularization posed a high risk for complications. We describe a novel approach for such revascularization, where the inflow source was the terminal brachiocephalic artery, outflow to the upper left brachial artery, with anatomic intrathoracic-to-axillary tunneling through the thoracic outlet after verifying the lack of dynamic extrinsic compression at that level. RESULT: The procedure resulted in resolution of the symptoms and the patient continued to do well 2 years later. CONCLUSION: This case shows that anatomic tunneling through the thoracic outlet can be a viable option for upper extremity revascularization when hostile conditions preclude other anatomic tunneling routes or extra-anatomic options.

Visceral Artery Aneurysms: Decision Making and Treatment Options in the New Era of Minimally Invasive and Endovascular Surgery.

The abdominal viscera blood supply is derived from anterior branches of the abdominal aorta. Visceral artery aneurysms (VAAs) include aneurysms of the following arteries and their branches: the celiac artery, the hepatic artery, the splenic artery, the superior mesenteric artery, the inferior mesenteric artery, the pancreaticoduodenal artery, and the gastroduodenal artery. Overall VAAs comprise < 2% of all types of arterial aneurysms. Asymptomatic VAAs are now being encountered more frequently due to the widespread use of advanced diagnostic abdominal imaging. The incidental finding of a VAA frequently leaves clinicians with a dilemma as to the best course of management. The focus of this review is on current treatment options and management guidelines for both symptomatic and asymptomatic VAAs.

Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis.

BACKGROUND: The ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) previously reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not prevent postthrombotic syndrome (PTS) in patients with acute proximal deep vein thrombosis. In the current analysis, we examine the effect of PCDT in ATTRACT patients with iliofemoral deep vein thrombosis. METHODS: Within a large multicenter randomized trial, 391 patients with acute deep vein thrombosis involving the iliac or common femoral veins were randomized to PCDT with anticoagulation versus anticoagulation alone (No-PCDT) and were followed for 24 months to compare short-term and long-term outcomes. RESULTS: Between 6 and 24 months, there was no difference in the occurrence of PTS (Villalta scale ≥5 or ulcer: 49% PCDT versus 51% No-PCDT; risk ratio, 0.95; 95% CI, 0.78-1.15; P=0.59). PCDT led to reduced PTS severity as shown by lower mean Villalta and Venous Clinical Severity Scores ( P<0.01 for comparisons at 6, 12, 18, and 24 months), and fewer patients with moderate-or-severe PTS (Villalta scale ≥10 or ulcer: 18% versus 28%; risk ratio, 0.65; 95% CI, 0.45-0.94; P=0.021) or severe PTS (Villalta scale ≥15 or ulcer: 8.7% versus 15%; risk ratio, 0.57; 95% CI, 0.32-1.01; P=0.048; and Venous Clinical Severity Score ≥8: 6.6% versus 14%; risk ratio, 0.46; 95% CI, 0.24-0.87; P=0.013). From baseline, PCDT led to greater reduction in leg pain and swelling ( P<0.01 for comparisons at 10 and 30 days) and greater improvement in venous disease-specific quality of life (Venous Insufficiency Epidemiological and Economic Study Quality of Life unit difference 5.6 through 24 months, P=0.029), but no difference in generic quality of life ( P>0.2 for comparisons of SF-36 mental and physical component summary scores through 24 months). In patients having PCDT versus No-PCDT, major bleeding within 10 days occurred in 1.5% versus 0.5% ( P=0.32), and recurrent venous thromboembolism over 24 months was observed in 13% versus 9.2% ( P=0.21). CONCLUSIONS: In patients with acute iliofemoral deep vein thrombosis, PCDT did not influence the occurrence of PTS or recurrent venous thromboembolism. However, PCDT significantly reduced early leg symptoms and, over 24 months, reduced PTS severity scores, reduced the proportion of patients who developed moderate-or-severe PTS, and resulted in greater improvement in venous disease-specific quality of life. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00790335.

Distal landing zone optimization before endovascular repair of aortic dissection.

BACKGROUND: The general goals of endovascular management in chronic distal thoracic aortic dissection are optimizing the true lumen, maintaining branch patency, and promoting false lumen (FL) thrombosis. Distal seal can be challenging in chronic distal thoracic aortic dissection due to the well-established secondary fenestrations and fibrotic septum. We describe our approach of distal landing zone optimization (DLZO) to enable full-diameter contact of the distal endoprosthesis. MATERIALS AND METHODS: Our experience includes 19 procedures in 16 patients (12 male, age 68 ± 8 years) between May 2014 and November 2017. A history of previous ascending repair for type A dissection was present in 8 patients. Treatment indication was enlarging aneurysm in all subjects, and 4 patients had associated chronic visceral or distal ischemia. Point septal fenestrations were expanded by serial balloon dilation and/or wire-pull approaches. Balloon molding was used to ensure complete endograft apposition and FL collapse. RESULTS: One death occurred due to aortic perforation during wire-pull fenestration in a patient with heavily calcified and angulated aorta. The remaining procedures were accomplished safely and successfully. Balloon fenestration was used in 16 procedures, alone or in combination with a limited wire pull component. Adjunct procedures for distal seal included surgeon-modified fenestrated stent graft (3), iliac branch device (3), parallel superior mesenteric artery stent-graft (1), renal artery or superior mesenteric artery stent-graft (4), iliac stent (3), and plug obliteration of FL (5). Reintervention was required in 3 patients due to delayed loss of seal after the initial procedure (3, 8, and 12 months). Two were managed by repeat DLZO and distal extension. The third had distal extension via a surgeon-modified fenestrated stent-graft component. Follow-up imaging was available in 14 patients (16.0 ± 12.5 months, range: 1-33), with stable or regressed sac diameter with complete or near-complete thrombosis of the FL in all patients. CONCLUSIONS: DLZO enabled creation of a distal seal zone in all patients. Residual retrograde filling of the FL is a marker of procedure failure, especially when seal segment length or feasible endoprosthesis oversizing are marginal. Insufficient landing segment can be circumvented with the use of a fenestrated or branched device to accomplish seal in the visceral aorta or iliac bifurcation. Adjunct FL ablation is also a valuable technique to promote FL thrombosis.

Current status of carbon dioxide angiography.

OBJECTIVE: Unfamiliarity of endovascular surgeons with carbon dioxide (CO2) angiography is one of the main reasons for its limited use. This review is intended to familiarize the reader with the principles and applications of that modality. METHODS: We conducted a comprehensive review of contemporary literature related to CO2 angiography and its use in the field of vascular and endovascular surgery, including technical details and diagnostic and interventional applications. RESULTS: Cardinal physicochemical characteristics of CO2 include buoyancy, ultralow viscosity, and nonmixing with blood. Because of the risk of neurotoxicity, intra-arterial CO2 angiography should only be performed below the diaphragm. Venous CO2 angiography can be performed anywhere in the torso and extremities. Ultralow viscosity enables intraprocedural imaging during vascular interventions without the need to exchange for an angiographic catheter. Benefits, advantages, and emerging applications of CO2 angiography are listed. Potential complications and their avoidance and troubleshooting are discussed. CONCLUSIONS: CO2 holds promise as an effective and versatile angiographic contrast agent. It is also a valuable modality for the guidance of endovascular interventions. Current availability of easy to use, safe, and portable CO2 delivery systems will likely expand the use of that modality even beyond the traditional indications of renal insufficiency and iodinated contrast allergy.

Endovascular recanalization of total occlusions of the mesenteric and celiac arteries.

OBJECTIVE: To evaluate our experience with the endovascular treatment of total occlusions of the mesenteric and celiac arteries. METHODS: We performed a retrospective review of endovascular stenting of 27 nonembolic total occlusions of the superior mesenteric artery (SMA) and celiac artery (CA) between July 2004 and July 2011 (26 patients, 16 females; mean age, 62 ± 13 years). A variety of demographic, lesion-related and procedure-related variables were evaluated for potential impact of technical success and patency. The follow-up protocol included clinical assessment, and color and spectral Doppler evaluation of the stented vessel(s). RESULTS: The clinical presentation was chronic mesenteric ischemia in 12 patients, acute mesenteric vascular syndromes in 10 patients, foregut ischemia/ischemic pancreatitis in three patients, and prior to endovascular repair of aortic aneurysm in one patient. The treated vessel was SMA in 22 procedures, CA in three, and both SMA and CA in one. Technical success was achieved in 23 of the 27 attempted recanalizations (85%). Three patients who failed the attempt underwent open bypass, and another one underwent retrograde recanalization and stenting of the SMA. Procedure success was only significantly related to patient age <70 years or procedure performance after the year 2006. Notably, the presence of a stump, ostial plaque, extensive vascular calcification, recanalization route (intraluminal vs subintimal), occlusion length, and vessel diameter had no significant impact on procedure success. Traditional duplex criteria proved unreliable in predicting restenosis. Life table analysis of freedom from symptom recurrence showed a primary and assisted rates of 58% and 80% at 1 year, and 33% and 60% at 2 years, respectively. Clinical recurrences developed in six patients (four presented with abdominal angina and weight loss, two presented with abdominal catastrophe). There were six access-related complications and no procedural deaths. Four delayed deaths occurred during follow-up (two cardiac causes, two due to abdominal sepsis). CONCLUSIONS: Endovascular recanalization of mesenteric artery occlusion is both feasible and successful, provided careful planning is used.

Anatomic bifurcated reconstruction of chronic bilateral innominate-superior vena cava occlusion using the Y-stenting technique.

This article presents the case of a 42-year-old man who presented with superior vena cava (SVC) syndrome due to fibrosing mediastinitis with multiple failed attempts at recanalization. We initially treated him with unilateral sharp needle recanalization of the right innominate vein into the SVC stump followed by stenting. Although his symptoms improved immediately, they did not completely resolve. Six months later, he returned with worsening symptoms, and venography revealed in-stent restenosis. The patient requested simultaneous treatment on the left side. The right stent was dilated, and a 3-cm-long occlusion of the left innominate vein was recanalized, again using sharp needle technique, homing into the struts of the right-sided stent. Following fenestration of the stent, a second stent was deployed from the left side into the SVC, and the two Y limbs were sequentially dilated to allow a true bifurcation anatomy (figure). The patient had complete resolution of his symptoms and continues to do well 6 months later.