Early Results From the Pivotal Trial Substudy of the GORE® EXCLUDER® Conformable Endoprosthesis in Angulated Necks.

OBJECTIVE OR BACKGROUND: To report the investigational device exemption (IDE) study 1-year clinical outcomes of the high neck angulation (HNA) substudy of the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) for treatment of infrarenal abdominal aortic aneurysms (AAA). METHODS: This study is a prospective, multicenter clinical trial conducted in the United States and included core laboratory assessment of imaging and independent event adjudication. Anatomic criteria for enrollment in the HNA substudy included infrarenal aortic neck angulation >60° and ≤90° with aortic neck length ≥10 mm. Primary safety endpoints included blood loss >1000 mL, death, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure, and thromboembolic events. Primary effectiveness endpoints included technical success, absence from Type I and III endoleak, migration (≥10 mm), sac enlargement (≥5 mm), sac rupture, and conversion to open repair. RESULTS: Between January 2018 and February 2022, 95 patients were enrolled in the HNA substudy across 35 sites. Of the 95 patients, 71 (74.7%) were male and the cohort average age was 74.4 years old. The mean infrarenal proximal aortic neck angle was 71.6° and mean AAA size was 62.9 mm. Overall technical success was achieved in 93 (97.9%) patients. Freedom from a primary safety endpoint through 30 days was 96.7%; 3 (3.3%) patients had blood loss >1000 mL. Freedom from the primary effectiveness at 12 months was achieved in 94.8%. Four (4.3%) patients had Type IA endoleak; intervention after the procedure was not required and no subsequent interventions or sac enlargement were noted in these patients. At 12 months, 29 (39.7%) patients experienced a Type II endoleak and 1 (1.3%) patient experienced AAA sac expansion ≥5mm. Through 12 months, 1 (1.3%) patient had a conversion to open surgical repair. There were no aneurysm-related deaths, ruptures, or migration through 12 months. CONCLUSIONS: The IDE study demonstrates safety and effectiveness of the EXCC device in AAA with highly angulated necks (>60° and ≤90°) are preserved at the 12-month follow-up.

Three-Year Outcomes of a US Pivotal Trial Substudy for Conformable Endoprosthesis in >=10 mm Non-Angulated Neck Anatomy.

OBJECTIVE: To report the midterm clinical outcomes from the GORE® EXCLUDER® Conformable AAA Endoprosthesis system (EXCC) pivotal regulatory trial in the United States (U.S.). METHODS: This is a prospective, multicenter, investigational device exemption clinical trial at 31 U.S. sites with Core Laboratory assessment of imaging and independent adjudication of safety. The study enrolled patients with abdominal aortic aneurysms (AAA) with a minimum proximal landing zone ≥ 10mm and proximal neck angulation of ≤ 60 degrees between December 2017 and February 2019 as part of a larger study to gain indications of the EXCC device. Endpoints included patient survival, freedom from secondary interventions, and stent-graft related outcomes. RESULTS: There were 80 patients enrolled (88.8% male, mean 73.5 ± 8.14 years-old). Mean maximum aortic diameter was 57.7±8.0 mm (range, 42.5-82.7). There was 100% freedom from type I and III endoleak and aneurysm-related mortality at 36-months. Freedom from secondary intervention was 91.9 ± (0.83, 0.96, 95% C.I.) at 36-months. There were no device fractures, migrations (>=10 mm), or aneurysm ruptures. At 36 months, thirteen patients (26.5%) had type 2 endoleak, 32 patients (58.2%) had AAA sac regression, 17 (30.9%) had no change in diameter, and 6 (10.9%) had sac enlargement. Seven patients (8.8%) through 36 months underwent reintervention. CONCLUSIONS: The 3-year outcomes have continued to show an adequate safety and efficacy profile of the EXCC device with no aneurysm related mortality or Type I/III endoleak. These results demonstrate durability for an EVAR device in US regulatory trials.

Technical pitfalls and proposed modifications of instructions for use for endovascular aortic aneurysm repair using the Gore Excluder conformable device in angulated and short landing zones.

We describe a case of an abdominal aortic aneurysm (AAA) and angulated proximal neck treated with a Gore Excluder conformable endoprosthesis and show relevant technical pitfalls in the deployment of the graft main body. An 82-year-old man presented with a 71-mm asymptomatic AAA with an angulated infrarenal proximal neck (75°) and was referred to our unit. The patient was treated with a 26-mm Gore Excluder conformable device, which was deployed slightly above the renal arteries after precatheterization of the lowest renal artery. The graft was then repositioned with support of the introducer sheath and a stiff guide wire. The proximal sealing zone was ballooned before the endograft delivery system was retrieved to avoid distal migration. Technical success was achieved. The patient was discharged with no complications. No type Ia endoleak was present on the 6-month computed tomography scan. Endovascular treatment of an AAA with a severe angulated proximal neck can be effective with a conformable stent graft if technical measures are used during deployment of the main body to optimize the seal.

Endovascular repair of right-sided iliac vein aneurysm and iliac arteriovenous fistula.

A 72-year-old man receiving anticoagulation therapy for chronic bilateral deep vein thromboses presented with acute right leg swelling. Right-sided imaging showed deep femoral vein thrombosis, chronic partial femoral vein thrombosis, and 4.8-cm distal external iliac vein dilation with possible right iliac vein stenosis. Venography confirmed common iliac vein occlusion and an aneurysm, with a fistula to the right internal iliac artery found by angiography. Aneurysm obliteration was achieved via arterial embolization with coils and an Amplatzer plug (Abbott, Chicago, IL). The patient continued with anticoagulation therapy, with patent common and external iliac arteries and a stable right external iliac vein aneurysm without arterial waveforms found on follow-up. His clinical manifestations were improved.

Intraoperative fusion imaging during transcarotid artery revascularization.

Background: Transcarotid artery revascularization (TCAR) with reverse-flow neuroprotection has emerged as an alternative to transfemoral carotid artery stenting and carotid endarterectomy. However, it requires fluoroscopic guidance, exposing the patient and surgeon to radiation. Although fusion-guided endovascular aneurysm repair has been demonstrated to significantly decrease this radiation risk, not much is known about similar outcomes for TCAR. The purpose of this study is to evaluate the outcomes at a single institution using fusion-guided imaging during TCAR compared with regional TCAR cases in the Vascular Quality Initiative (VQI) registry without fusion imaging. Methods: A retrospective analysis was conducted of data collected from all patients undergoing TCAR with fusion-guided imaging (TCAR-F) at our hospital and patients undergoing TCAR alone within the VQI database. The primary outcomes included the total operative time, dose area product, fluoroscopy time, contrast usage, and flow-reversal time. The demographics and preoperative risk factors were also assessed in both groups. Continuous outcomes were compared using the Welch t test. Categorical outcomes were compared using the Fisher exact test. Results: A total of 30 TCAR-F cases (January 2019 to May 2022) at our institution were compared against the regional VQI dataset (n = 2535). The TCAR-F cases had a lower dose area product (5.67 vs 93.1 Gy cm2; P < .0001), shorter fluoroscopy time (8.07 vs 16.4 minutes; P < .0001), and less contrast usage (13.49 vs 76.7 mL; P < .0001) compared with the regional averages of the same. The TCAR-F cases had a longer total operative time (117.3 vs 80.9 minutes; P < .0001) and flow-reversal time (14.4 vs 11.7 minutes; P = .025) compared with the regional cases. Conclusions: The results from this pilot study comparing TCAR-F patients at a single institution with VQI regional TCAR patients suggest that TCAR-F cases use less radiation and contrast compared with TCAR without fusion imaging. Fusion-guided imaging might provide radiation protection to both patients and surgeons and decrease contrast usage for the patient.

Abdominal aortic aneurysm and bilateral pelvic kidneys.

A 61-year-old man presented with a 5.8-cm abdominal aortic aneurysm with bilateral pelvic kidneys incidentally discovered by computed tomography angiography. Given the complex anatomy, an open approach was favored over an endovascular approach to address the aneurysm and preserve renal function. Renal perfusion was achieved with a short clamp time of 29 minutes and intermittent boluses of cold renal perfusion solution delivered into each renal artery via a Fogarty infusion catheter. We describe a rare case of bilateral ectopic kidneys in the setting of open abdominal aortic aneurysm repair using the described technique.

Open abdominal aortic repair in the current era has more complications for occlusive disease than for aneurysm repair.

BACKGROUND: Endovascular intervention has become the first-line treatment of patients with abdominal aortic aneurysms (AAAs) or aortoiliac occlusive disease (AIOD). However, open abdominal aortic repair remains a valuable treatment option for patients who are younger, those with unfavorable anatomy, and patients for whom endovascular intervention has failed. The cohort of patients undergoing open repair has become highly selected; nevertheless, updated outcomes or patient selection recommendations have been unavailable. In the present study, we explored and compared the characteristics and postoperative outcomes of patients who had undergone open abdominal aortic repair from 2009 to 2018. METHODS: Patients who had undergone open AAA (n = 9481) or AIOD (n = 9257) repair were collected from the National Surgical Quality Improvement Program database. The primary outcome was the 30-day mortality. The secondary outcomes included 30-day return to the operating room, total operative time, total hospital stay, and postoperative complications. Unmatched and matched differences between the two groups and changes over time were analyzed. Univariate and multivariate regression analyses were conducted to assess the risk factors predicting for 30-day mortality. RESULTS: After propensity matching (n = 4980), those in the AIOD group had had a higher 30-day mortality rate (5.1% vs 4.1%; P = .021), a higher incidence of wound complications (7.4% vs 5.1%; P<.0001) and an increased 30-day return to the operating room (14.2% vs 9.1%; P < .0001). More open AIOD cases (P = .02) and fewer open AAA cases (P = .04) had been treated in the second half of the decade than in the first. The factors associated with an increased odds of 30-day mortality included advanced age, American Society of Anesthesiologists score ≥III, functional dependence, blood transfusion <72 hours before surgery, weight loss in previous 6 months, and a history of chronic obstructive pulmonary disease. CONCLUSIONS: From 2009 to 2018, the number of open AAA repairs decreased and the proportion of open abdominal AIOD cases increased. Open AIOD surgery was associated with higher 30-day mortality, increased return to the operating room, and increased wound complications vs open AAA repair. Multiple risk factors increased the odds for perioperative mortality. Thus, open abdominal aortic repair should be selectively applied to patients with fewer risk factors.

Effect of Direct Oral Anticoagulants Versus Warfarin on Patency in High-Risk Bypass Patients.

BACKGROUND: The use of warfarin for anticoagulation in thromboembolic disease has been the mainstay of treatment. Direct oral anticoagulants (DOACs) have demonstrated equivalent anticoagulant effects, without increased bleeding risks or need for frequent monitoring. However, the role of DOACs remains unclear in the setting of replacing warfarin for high-risk peripheral artery disease (PAD) interventions. The purpose of this study is to evaluate the efficacy of DOACs compared to warfarin during the postoperative period in patients that underwent a lower extremity high-risk bypass (HRB). METHODS: The study is a single institution, retrospective review of all lower extremity HRBs between January 2012 and June 2021, who were previously placed on or started on anticoagulation with a DOAC or warfarin. The HRB group included all patients undergoing femoral to above or below knee bypass with an adjunct procedure, or below knee bypass with synthetic or composite vein conduit. All demographics, preoperative factors, and complications were evaluated with respect to DOAC versus warfarin. RESULTS: A total of 44 patients (28 males; average age 68.8 ± 10.9) underwent an HRB during the study period. There were no significant differences in demographics and preoperative characteristics between the 2 groups. Among patient comorbidities, coronary artery disease was found to be significantly higher in patients on DOACs (P = 0.03). The 12-month primary patency rate was 83.3% versus 57.1%, for DOAC versus warfarin respectively (P = 0.03). Multivariate analyses revealed that <30-day reinterventions contribute to 12-month patency (P = 0.02). CONCLUSIONS: Patients who underwent lower extremity HRB with postoperative DOAC appeared to exhibit higher graft patency rates than those who were placed on warfarin. Due to their low incidence of undesirable side effects and the lack of frequent monitoring, DOACs could be considered a safe alternative to warfarin in the postoperative period for patients with HRB.

Soleal venous aneurysm in a patient with a history of pulmonary embolism.

A lower extremity venous aneurysm is an uncommon vascular disease known to increase a patient's risk of pulmonary embolism. Although most will be popliteal venous aneurysms, crural aneurysms have been rarely documented. We have presented a rare case of a soleal venous aneurysm in a patient with a history of pulmonary embolism. Risk-reducing open aneurysm resection with lateral venorrhaphy was performed.

Iliac vein aneurysms associated with May-Thurner anatomy.

A 61-year-old woman with May-Thurner anatomy status post recent hysterectomy was found to have two iliac vein aneurysms on postoperative magnetic resonance imaging. Transfemoral venography showed the venous aneurysms received retrograde flow from the left internal iliac vein and the left common iliac vein (CIV) was compressed by the right common iliac artery. Both aneurysms were coil embolized and a left CIV stent was placed. Our initial experience suggests that iliac vein aneurysms may be caused by CIV compression and an endovascular approach is safe and effective to treat both lesions.

One-year results of the GORE EXCLUDER Conformable AAA Endoprosthesis system in the United States regulatory trial.

OBJECTIVE: To report the 1-year clinical outcomes from the GORE EXCLUDER Conformable AAA Endoprosthesis system in the US regulatory trial. METHODS: The study is a prospective, multicenter, investigational device exemption clinical trial at 31 US sites with core laboratory assessment of imaging and independent event adjudication. The primary safety (incidence of major adverse events at 30 days) and effectiveness end points (successful aneurysm treatment at 1 year) were assessed in a cohort of patients with abdominal aortic aneurysms (AAAs). RESULTS: We enrolled 80 patients between December 19, 2017, and February, 27, 2019. The mean maximum aortic diameter was 57.7 ± 7.95 mm (range, 42.5-82.7 mm) with an average patient age of 73.5 ± 8.14 years (range, 56-96 years). Overall technical success was 100% (80/80). The mean hospital length stay was 1.2 ± 0.6 days (range, 1-4 days). No primary safety end point events were observed, including no death, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure, procedural blood loss of more than 1000 mL, or thromboembolic events including limb occlusion or distal emboli. There were no type I or III endoleaks detected on the 1-, 6-, or 12-month follow-up computed tomography scans. There were no stent fractures, device migrations (≥10 mm), AAA ruptures, or conversions to open surgical repair observed. Two patients had AAA sac growth of more than 5 mm at 1 year owing to type II endoleaks. There were no aneurysm-related deaths within the 12-month follow-up, and freedom from aneurysm-related mortality was 100% through 1 year. CONCLUSIONS: The safety and effectiveness of the GORE EXCLUDER Conformable AAA Endoprosthesis system has been demonstrated with 98.5% freedom from primary effectiveness end point events at 1 year and 100% freedom from primary safety end point events assessed through 30 days.

Open conversion after failed endovascular aneurysm repair is increasing and its 30-day mortality is higher than that after primary open repair.

BACKGROUND: Endovascular aneurysm repair (EVAR) has become the preferred treatment of abdominal aortic aneurysms (AAAs). Recent studies have demonstrated that cases of EVAR failure repair and subsequent open conversion have increased. The aim of the present study was to evaluate the national trend of annual cases and assess the 30-day outcomes of conversion to open repair after failed EVAR compared with primary open repair. METHODS: The National Surgical Quality Improvement Program database was queried for relevant Current Procedural Terminology and International Classification of Diseases, Ninth and Tenth Revision, codes to identify patients who had undergone conversion to open repair or primary open repair of nonruptured AAAs from 2009 to 2018. The annual trend of cases was assessed, and the perioperative outcomes of both procedures were compared. Multivariable logistic regression analyses were conducted to identify independent perioperative factors associated with mortality. RESULTS: Of the 9635 patients with nonruptured AAAs included in the present analysis, 9250 had undergone primary repair and 385 had required open conversion. During the 10-year period, the annual number of cases of open conversion had steadily increased and that of primary repair had decreased. The incidence of postoperative complications was similar between both groups, except for cardiac arrest, which had occurred more frequently in the open conversion group. The 30-day mortality was higher in the open conversion group than in the primary group (9.6% vs 3.9%; P < .0001). Open conversion was also independently associated with higher odds of death (adjusted odds ratio [OR], 2.1; 95% confidence interval [CI], 1.8-2.4; P < .0001). When the average mortality in both groups was compared between the first and last 5 years, no difference was found (open conversion: 9.8% vs 9.5% [P = 1.00]; primary repair: 3.6% vs 4.2% [P = .19]). Other perioperative factors independently associated with mortality included increased age (OR, 1.8; 95% CI, 1.5-2.1; P < .0001), American Society of Anesthesiologists class ≥III (OR, 2.7; 95% CI, 1.1-6.6; P = .029), insulin-dependent diabetes (OR, 2.0; 95% CI, 1.2-3.3; P = .005), chronic obstructive pulmonary disease (OR, 1.4; 95% CI, 1.1-1.8; P = .006), the presence of dyspnea at rest (OR, 3.3; 95% CI, 1.8-6.1; P < .0001), and a high preoperative hematocrit (OR, 0.94; 95% CI, 0.93-0.97; P < .0001). CONCLUSIONS: Open conversion to treat nonruptured AAAs after failed EVAR was independently associated with higher mortality. Also, the annual cases of open conversion have continued to increase without any significant changes in postoperative mortality. This highlights the danger of open conversion and stresses the need for better solutions to prevent and manage EVAR failure.

Contained abdominal aortic rupture secondary to follicular lymphoma invasion.

An 87-year-old woman with grade IIIb follicular lymphoma treated with rituximab had presented with nausea, emesis, and chest pain of 1 day duration. She was found to have a contained abdominal aortic rupture secondary to follicular lymphoma invasion. She safely and successfully underwent emergent endovascular aortic repair. We have described a rare case of extranodal disease in follicular lymphoma associated with abdominal aortic pseudoaneurysms, likely due to a combination of malignancy-induced chronic inflammation and radiation therapy and chemotherapy side effects.

Extended Use of Distal Embolic Protection Devices in Treatment of Distal Embolism During Lower Extremity Arterial Endovascular Interventions.

There is no consensus on the best treatment modality for acute distal embolization complications during endovascular interventions for peripheral arterial diseases. We report on 3 patients who underwent mechanical embolectomy using a distal embolic protection device (EPD). All patients showed angiographic evidence of distal embolism, which occurred during lower extremity limb salvage endovascular procedures. After embolectomy, all had complete recanalization of the involved vessel on completion angiogram, and none had any device-related complications or adverse outcomes from the embolization. This initial experience suggests that EPD can be used for both the prevention and treatment of intraoperative distal embolization during endovascular intervention of lower extremity arterial disease.

Internal jugular to internal jugular vein bypass of symptomatic central vein obstruction.

INTRODUCTION: Central venous obstruction (CVO) often arises among hemodialysis patients with upper extremity access due to a varying number of risk factors. While the true incidence of CVO in hemodialysis patients is unknown, it been reported in the range of 20%-40% in dialysis patients undergoing venograms. In the non-hemodialysis population, chronic central vein obstruction has a compensatory mechanism comprised of numerous collaterals along the chest wall, neck, and mediastinum. However, the presence of an AVF or AVG ipsilateral to a central venous stenosis or occlusion can overwhelm the collateral network due to the significantly elevated blood flow. This may result in severe and debilitating upper extremity and fascial swelling. While ligation results in almost instantaneous symptomatic relief, it does not address the patient's underlying pathologic process and necessitates an additional access. As these patients continue to live longer, our strategies to manage these failing accesses are becoming increasingly complex. The goal of preserving existing access while correcting any symptoms is paramount. Previous case reports have documented various surgical options for preserving an existing access. CASE PRESENTATION: Our patient is a 49-year-old female with hypertension and end-stage renal disease, on hemodialysis through a right arm arteriovenous (AV) fistula. She had a history of multiple AV fistulae creations in the past, all of which previously thrombosed. Several years after the creation of her most recent fistula, she developed severe throbbing headaches, right arm and facial swelling, right eye lacrimation, and blurry vision. AV fistula angiogram demonstrated right brachiocephalic vein chronic occlusion and endovascular revascularization through both trans-AVF and transfemoral approaches were attempted, but unsuccessful. DISCUSSION: This case illustrates the success of the creation of an internal jugular-jugular vein bypass to maintain a right arm arteriovenous fistula, while at the same time, correcting the symptoms of a right brachiocephalic vein occlusion.

Amplatzer Vascular Plug for Complicated Residual DeBakey Type 1 Aortic Dissection in the Aortic Arch.

Surgical treatment of acute DeBakey type I aortic dissection does not address the entire aorta, which can leave anatomically complex residual aortic dissection in the aortic arch and descending aorta. Open repair has been the standard treatment for this pathology. When the lesions are located in the aortic arch, re-do total arch replacement needs to be performed. Plug placement to close small entry tears in the aortic arch has been reported. This article reports about a 79-year-old man who underwent hemiarch replacement for acute DeBakey type I aortic dissection. One year later, his proximal descending aorta dilated to 6.3 cm. The patient was treated with Amplatzer plug in the false lumen, and a stent graft was placed in the true lumen. Follow-up computed tomography scan confirmed complete thrombosis of the false lumen in the descending aorta which had decreased from 6.3 to 4.0 cm. Plug placement in the false lumen in the aortic arch is a potential treatment strategy for anatomically complex residual aortic dissection to induce thrombosis of the false lumen and encourage remodeling.

Compartment syndrome secondary to viral myositis as initial presentation in COVID-19 patient.

Coronavirus disease 2019 (COVID-19) is an infectious disease typically manifested as a respiratory infection with a range of symptoms from a mild viral illness to a severe acute respiratory syndrome with multiorgan failure and death. We report a case of a young man presenting with compartment syndrome secondary to COVID-19 viral myositis, with a protracted hospital course further complicated by extensive venous and arterial thrombosis. As the coronavirus pandemic evolves, our understanding of the virus continues to improve; however, a host of unanswered questions remain about atypical presentation and management and treatment options.