Implications and late outcomes of type II endoleaks after endovascular aneurysm repair.

OBJECTIVE: Type II endoleaks (T2ELs) are the most common cause of reintervention after endovascular aneurysm repair (EVAR). Although most resolve spontaneously, the long-term implications of T2ELs remain elusive. We aim to evaluate the impact of persistent and late T2ELs on clinical outcomes after EVAR. METHODS: This was a single-institution retrospective review of patients who underwent EVAR for degenerative infrarenal abdominal aortic aneurysm between January 2010 and June 2022 with no type I (T1EL) or III (T3EL) endoleak seen at EVAR completion. Patients were categorized based on T2EL status. Group 1 included patients with never detected or transient T2ELs (detected at EVAR completion but not after). Group 2 encompassed persistent T2ELs (seen at EVAR completion and again during follow-up) and late T2ELs (detected for the first time at any point during follow-up). Time-to-event analysis was conducted using a time-dependent approach to T2EL status. Primary outcomes included freedom from sac enlargement (SE), aneurysm-related reinterventions, and overall survival. RESULTS: A total of 803 patients met inclusion criteria. Group 1 included 418 patients (52%), of which 85% had no T2ELs and 15% had transient T2ELs. Group 2 had 385 patients; 23% had persistent T2ELs, and 77% developed a new T2EL. Patients in group 1 had a higher prevalence of smoking (88% vs 83%; P < .001), chronic obstructive pulmonary disease (33% vs 25%; P = .008), chronic kidney disease (13% vs 8%; P = .021), and a higher mean Society for Vascular Surgery score (7 vs 6 points; P = .049). No differences were found in aneurysm diameter or morphology. Mean follow-up was 5 years for the entire cohort. In Group 2, 58 patients (15%) underwent T2EL treatment, most commonly transarterial embolization. At 10 years after EVAR, Group 2 was associated with lower freedom from SE (P < .001) and abdominal aortic aneurysm-related reinterventions (P < .001) and comparable overall survival (P = .42). More T1ELs were detected during follow-up in Group 2 (6 [1%] vs 20 [5%]; P = .004), with 15 (75%) of these detected at a median of 3 years after the T2EL. No difference between groups was observed in explant (0.7% vs 2.1%; P = .130) or aneurysm rupture (0.5% vs 1.3%; P = .269) rates. CONCLUSIONS: One-half of patients treated with infrarenal EVAR developed persistent/late T2ELs, which are associated with a higher risk of SE and reinterventions. No difference in overall survival or aneurysm rupture risk was seen at 10 years, based on T2EL status or T2EL intervention. A conservative approach to T2ELs may be appropriate for most patients with absent T1ELs or T3ELs.

Hybrid repair of tandem high-grade innominate and carotid artery stenosis in an asymptomatic male.

Tandem atherosclerotic lesions of the innominate artery (IA) and internal carotid artery (ICA) are challenging and represent an inherent risk of cerebrovascular accident. Treating asymptomatic patients is controversial; therefore, it is critical to minimize the risk of a cerebrovascular accident if repair is undertaken. An asymptomatic 78-year-old man with a chronically occluded left ICA and tandem stenoses of the IA and right ICA underwent a hybrid intervention with stenting of the IA lesion and right ICA endarterectomy. The intra- and postoperative course was successful, without any signs of neurological sequelae. Sixteen months later, the patient remained asymptomatic, with patent reconstructions.

Flow diverter stents for endovascular treatment of aneurysms: a comparative study of efficacy and safety between FREDX and FRED.

BACKGROUND: The FRED X flow diverter (FREDX), as the second generation in the FRED series, aims to improve the treatment of cerebral aneurysms. This study compares the efficacy and safety of FREDX with its predecessor, FRED. METHODS: This prospective registry included patients treated with FRED and FREDX devices. Efficacy was assessed using digital subtraction angiography with 3D volumetric reconstruction at immediate and 1 year follow-ups. Safety was evaluated by recording complications, analyzed through univariate contrasts, generalized mixed models, and Bayesian network analyses. RESULTS: We treated 287 patients with 385 aneurysms, with 77.9% receiving FRED and 22.1% FREDX. The median age was 55 years (IQR 47-65) and 78.4% were women. The FREDX group showed a higher prevalence of saccular-like aneurysms (70.6% vs 52.7%, P=0.012) and a higher rate of complete occlusion compared with FRED interventions (79.4% vs 59.3%, P=0.022). After adjusting for confounders, these differences represented a 3.04-fold increased likelihood (95% CI 1.44 to 6.41, P=0.003) of achieving complete occlusion at 1 year with FREDX interventions. Regarding safety, two (3.5%) complications (both non-symptomatic) were observed in the FREDX group and 23 (10.4%) in the FRED group (P=0.166). Bayesian network analysis suggested a trend towards fewer complications for FREDX, with a median reduction of 5.5% in the posterior distribution of the prevalence of complications compared with FRED interventions. CONCLUSIONS: The FREDX device shows improved complete occlusion rates at 1 year compared with the FRED device while maintaining a favourable safety profile, indicating its potential advantage in the treatment of cerebral aneurysms.

Outcomes of lower extremity arterial bypass using the Human Acellular Vessel in patients with chronic limb-threatening ischemia.

OBJECTIVE: Patients with chronic limb-threatening ischemia (CLTI) and no great saphenous vein to use as a conduit for arterial bypass have a high risk for amputation despite advances in medical and endovascular therapies. This report presents findings from a U.S. Food and Drug Administration (FDA) supported study of the Human Acellular Vessel (HAV) (Humacyte Inc.) used as a conduit for arterial bypass in patients with CLTI and inadequate or absent autologous conduit. METHODS: The HAV is a 6-mm, 40-cm vessel created from human vascular smooth muscle cells seeded onto a polyglycolic acid scaffold pulsed in a bioreactor for 8 weeks as cells proliferate and the scaffold dissolves. The resultant vessel is decellularized, creating a nonimmunogenic conduit composed of collagen, elastin, and extracellular matrix. The FDA issued an Investigational New Drug for an intermediate-sized, single-center study of the HAV under the agency's Expanded Access Program in patients with advanced CLTI and inadequate or absent autologous conduit. Technical results and clinical outcomes were analyzed and reported. RESULTS: Between March 2021 and July 2023, 29 patients (20 males; mean age, 71 ± 11 years) underwent limb salvage operation using the HAV as a bypass conduit. Most patients had advanced CLTI (Rutherford class 5/6 in 72%; wound, ischemia, and foot infection stage 3/4 in 83%), and 97% had previously failed revascularization(s) of the extremity. Two HAVs were sewn together to attain the needed bypass length in 24 patients (83%). Bypasses were to tibial arteries in 23 patients (79%) and to the popliteal artery in 6 (21%). Technical success was 100%, and the 30-day mortality rate was 7% (2 patients). With 100% follow-up (median, 9.3 months), the limb salvage rate was 86% (25/29 patients). There were 16 reinterventions to restore secondary patency, of which 15 (94%) were successful. Primary and secondary patency of the HAV at 9 months were 59% and 71%, respectively. CONCLUSIONS: The HAV has demonstrated short- to intermediate-term safety and efficacy as an arterial bypass conduit in a complex cohort of patients with limb-threatening ischemia and no autologous options. This experience using the FDA's Expanded Access Program provides real-world data to inform regulatory deliberations and future trials of the HAV, including the study of the vessel as a first-line bypass conduit in less severe cases of chronic limb ischemia.

Cryopreserved arterial allografts vs autologous vein for arterial reconstruction in infected fields.

OBJECTIVE: Peripheral arterial infections are rare and difficult to treat when an in situ reconstruction is required. Autologous vein (AV) is the conduit of choice in many scenarios. However, cryopreserved arterial allografts (CAAs) are an alternative. We aimed to assess our experience with CAAs and AVs for reconstruction in primary and secondary peripheral arterial infections. METHODS: Data from patients with peripheral arterial infections undergoing reconstruction with CAA or AV from January 2002 through August 2022 were retrospectively analyzed. Patients with aortic- or iliac-based infections were excluded. RESULTS: A total of 42 patients (28 CAA, 14 AV) with a mean age of 65 and 69 years, respectively, were identified. Infections were secondary in 31 patients (74%) and primary in 11 (26%). Secondary infections included 10 femoral-femoral grafts, 10 femoropopliteal or femoral-distal grafts, five femoral patches, four carotid-subclavian grafts, one carotid-carotid graft, and one infected carotid patch. Primary infection locations included six femoral, three popliteal, and two subclavian arteries. In patients with lower extremity infections, associated groin infections were present in 19 (56%). Preoperative blood cultures were positive in 17 patients (41%). AVs included saphenous vein in eight and femoral vein in six. Intraoperative cultures were negative in nine patients (23%), polymicrobial in eight (21%), and monomicrobial in 22 (56%). Thirty-day mortality occurred in four patients (10%), two due to multisystem organ failure, one due to graft rupture causing acute blood loss and myocardial infarction, and one due to an unknown cause post-discharge. Median follow-up was 20 months and 46 months in the CAA and AV group, respectively. Graft-related reintervention was performed in six patients in the CAA group (21%) and one patient in the AV group (7%). Freedom from graft-related reintervention rates at 3 years were 82% and 92% in the CAA and AV group, respectively (P = .12). Survival rates at 1 and 3 years were 85% and 65% in the CAA group and 92% and 84% in the AV group (P = .13). Freedom from loss of primary patency was similar with 3-year rates of 77% and 83% in the CAA and AV group, respectively (P = .25). No patients in either group were diagnosed with reinfection. CONCLUSIONS: CAAs are an alternative conduit for peripheral arterial reconstructions when AV is not available. Although there was a trend towards higher graft-related reintervention rates in the CAA group, patency is similar and reinfection is rare.

Management of Endoleaks After Elective Infrarenal Aortic Endovascular Aneurysm Repair: A Review.

Importance: Endovascular aneurysm repair (EVAR) is the dominant treatment strategy for abdominal aortic aneurysms, encompassing 80% of all repairs in the United States. Endoleaks are ubiquitous and affect 30% of patients treated by EVAR, potentially leading to sac enlargement and increased risk of rupture. The care of EVAR patients requires long-term surveillance by a multidisciplinary team. Accordingly, physicians should be familiar with the fundamentals of endoleak management to achieve optimal outcomes, including timely referral for remediation or providing counseling and reassurance when needed. Observations: PubMed and the Cochrane database were searched for articles published between January 2002 and December 2022 in English, addressing epidemiology, diagnosis, and management of endoleaks after EVAR. Endoleaks can be detected intraoperatively or years later, making lifelong surveillance mandatory. Type I and III have the highest risk of rupture (7.5% at 2 years and 8.9% at 1 year, respectively) and should be treated when identified. Intervention should be considered for other types of endoleak when associated with aneurysm sac growth larger than 5 mm based on current guidelines. Type II endoleaks are the most common, accounting for 50% of all endoleaks. Up to 90% of type II endoleaks resolve spontaneously or are not associated with sac enlargement, requiring only observation. Although the risk of rupture is less than 1%, cases that require reintervention are challenging. Recurrence is common despite endovascular treatment, and rupture can occur without evidence of sac growth. Type IV endoleaks and endotension are uncommon, are typically benign, and primarily should be observed. Conclusions and Relevance: Endoleak management depends on the type and presence of sac expansion. Type I and III endoleaks require intervention. Type II endoleaks should be observed and treated selectively in patients with significant sac expansion. Since endoleaks can appear any time after EVAR, at least 1 contrast-enhanced computed tomographic angiogram or duplex ultrasound by an experienced laboratory is recommended every 5 years.

Cryopreserved arterial allografts vs rifampin-soaked Dacron for the treatment of infected aortic and iliac grafts.

OBJECTIVE: Aortic and iliac graft infections remain complex clinical problems with high mortality and morbidity. Cryopreserved arterial allografts (CAAs) and rifampin-soaked Dacron (RSD) are options for in situ reconstruction. This study aimed to compare the safety and effectiveness of CAA vs RSD in this setting. METHODS: Data from patients with aortic and iliac graft infections undergoing in situ reconstruction with either CAA or RSD from January 2002 through August 2022 were retrospectively analyzed. Our primary outcomes were freedom from graft-related reintervention and freedom from reinfection. Secondary outcomes included comparing trends in the use of CAA and RSD at our institution, overall survival, perioperative mortality, and major morbidity. RESULTS: A total of 149 patients (80 RSD, 69 CAA) with a mean age of 68.9 and 69.1 years, respectively, were included. Endovascular stent grafts were infected in 60 patients (41 CAA group and 19 RSD group; P ≤ .01). Graft-enteric fistulas were more common in the RSD group (48.8% RSD vs 29.0% CAA; P ≤ .01). Management included complete resection of the infected graft (85.5% CAA vs 57.5% RSD; P ≤ .01) and aortic reconstructions were covered in omentum in 57 (87.7%) and 63 (84.0%) patients in the CAA and RSD group, respectively (P = .55). Thirty-day/in-hospital mortality was similar between the groups (7.5% RSD vs 7.2% CAA; P = 1.00). One early graft-related death occurred on postoperative day 4 due to CAA rupture and hemorrhagic shock. Median follow-up was 20.5 and 21.5 months in the CAA and RSD groups, respectively. Overall post-discharge survival at 5 years was similar, at 59.2% in the RSD group and 59.0% in the CAA group (P = .80). Freedom from graft-related reintervention at 1 and 5 years was 81.3% and 66.2% (CAA) vs 95.6% and 92.5% (RSD; P = .02). Indications for reintervention in the CAA group included stenosis (n = 5), pseudoaneurysm (n = 2), reinfection (n = 2), occlusion (n = 2), rupture (n = 1), and graft-limb kinking (n = 1). In the RSD group, indications included reinfection (n = 3), occlusion (n = 1), endoleak (n = 1), omental coverage (n = 1), and rupture (n = 1). Freedom from reinfection at 1 and 5 years was 98.3% and 94.9% (CAA) vs 92.5% and 87.2% (RSD; P = .11). Two (2.9%) and three patients (3.8%) in the CAA and RSD group, respectively, required graft explantation due to reinfection. CONCLUSIONS: Aorto-iliac graft infections can be managed safely with either CAA or RSD in selected patients for in situ reconstruction. However, reintervention was more common with CAA use. Freedom from reinfection rates in the RSD group was lower, but this was not statistically significant. Conduit choice is associated with long-term surveillance needs and reinterventions.

Covered endovascular reconstruction of the aortic bifurcation with inferior mesenteric artery chimney for management of bilateral lower extremity tissue loss with concomitant mesenteric stenosis.

Aortoiliac occlusive disease involving mesenteric branches poses an interesting challenge. Although an open surgical approach is considered the gold standard, endovascular techniques such as covered endovascular reconstruction of the aortic bifurcation with inferior mesenteric artery chimney have been presented as alternatives for patients unfit for major surgical repair. A 64-year-old man with bilateral chronic limb-threatening ischemia and severe chronic malnutrition underwent covered endovascular reconstruction of the aortic bifurcation with inferior mesenteric artery chimney due to significant intraoperative risk. We have presented the operative technique used. The intraoperative course was successful, and, postoperatively, the patient underwent successful, planned, left below-the-knee amputation and his right lower extremity wounds healed.

Cryopreserved Arterial Allografts Versus Rifampin-Soaked Dacron for the Treatment of Infected Aortic and Iliac Aneurysms.

BACKGROUND: Infected aortic and iliac artery aneurysms are challenging to treat. Cryopreserved arterial allografts (CAAs) or rifampin-soaked Dacron (RSD) are standard options for in situ reconstruction. Our aim was to compare the safety and effectiveness of CAA versus RSD for these complex pathologies. METHODS: This is a retrospective review of infected iliac, abdominal, and thoracoabdominal aortic aneurysms treated with either CAAs or RSD between 2002 and 2022 at our institution. The diagnosis was confirmed by intraoperative, radiologic, or microbiological evidence of aortic infection. Perioperative events, 30-day and long-term mortality, reinfection, and reintervention were analyzed. RESULTS: Thirty patients (17 CAA, 13 RSD) with a mean age of 61 and 68 years, respectively, were identified. The infected aneurysm was most commonly suprarenal or infrarenal. Culture-negative infections were present in 47% of the CAA group and 54% in the RSD group. Early major morbidity was 57% and 54% for the CAA and RSD, respectively. Thirty-day mortality was similar between groups (18% vs. 23% CAA vs. RSD, P ≥ 0.99). Median follow-up was longer in the RSD group (14.5 months vs. 13 months). Overall survival at 1 and 5 years was 80.8% and 64.8% in the CAA group and 69.2% and 57.7% in the RSD group. Reinterventions only occurred with CAA repairs and indications included graft occlusion (2), multiple pseudoaneurysms and reinfection (1), and hemorrhagic shock caused by graft rupture (1). Freedom from reintervention at 1 and 3 years was 87.5% and 79.5% (CAA group) versus 100% and 100% (RSD, P = 0.06). Freedom from reinfection at 1 year was 100% in both groups, while at 3 years it was 90.9% for the CAA group and 100% for the RSD group (P = 0.39). CONCLUSIONS: Infected aortic and iliac aneurysms have high early morbidity and mortality. CAA and RSD had similar outcomes in our series; CAA trended toward higher reintervention rates. Both remain viable options for complex scenarios but require close surveillance.

Association between cardiac conditions with venous leg ulcers in patients with chronic venous insufficiency.

INTRODUCTION: Venous leg ulcers (VLUs) are the final stage of chronic venous insufficiency. This study aims to characterize the association between cardiovascular diseases and VLU. METHODS: A multicentric case-control study analyzed 17,788 patients between 2015 and 2020. Cases were matched (1:2) by age and sex, and odds ratios (OR) were analyzed with conditional logistic regressions adjusted by risk factors. RESULTS: The prevalence of VLU was 15.2%. 2390 cases were analyzed. Diseases found to be associated with VLU were atrial fibrillation (OR, 1.21; 95% CI: 1.03-1.42), pulmonary hypertension (OR, 1.45; 95% CI: 1.06-2.00), right heart failure (OR, 1.27; 95% CI: 1.13-1.43), peripheral artery disease (OR, 2.21; 95% CI: 1.90-2.56), and history of pulmonary embolism (OR, 1.45; 95% CI: 1.06-2.00). CONCLUSIONS: Certain cardiovascular conditions showed an association with VLU. Further studies are warranted to evaluate the effect that treating concomitant cardiovascular diseases might exert on the natural history of venous leg ulcers.

Two-Year Results of a First-In-Human Study in Patients Surgically Implanted With a Bioprosthetic Venous Valve, the VenoValve in Patients With Severe Chronic Venous Insufficiency.

OBJECTIVE: Two-year follow-up results from a first-in-human study of patients implanted with the VenoValve are evaluated for supporting the long-term clinical safety and performance of the device. BACKGROUND: Chronic Venous Insufficiency (CVI) involves improper functioning of lower limb vein valves and inability of these valves to move blood back towards the heart. CVI symptoms include swelling, varicose veins, pain, and leg ulcers. Currently, there is no cure for this condition and treatment options are limited. This study provides 2-year outcomes for 8 patients who were implanted with the bioprosthetic VenoValve for treating severe CVI with deep venous reflux measured at the mid-popliteal vein. The 6-month and 1-year results were previously published. METHODS: Eleven patients with C5 & C6 CVI were implanted with VenoValve into the midthigh femoral vein and followed for 2 years. Assessed clinical outcomes include device-related adverse events, reflux time, disease severity, and pain scores. RESULTS: All 11 implant procedures were successful. Two-year follow-up data was obtained for 8 subjects: 1 patient died of non-device related causes, 1 was lost to follow-up, and 1 refused to follow-up due to the COVID-19 pandemic. No device-related adverse events occurred between the first and second years of follow-up. Reported 2-year clinical performance outcomes included significant decreases in mean reflux times of the mid-popliteal vein (61%), and significant improvements in mean scores for disease severity rVCSS (56%) and VAS pain (87%). CONCLUSIONS: Results from this study support long-term safety and effectiveness of the VenoValve for improving CVI severity by reducing reflux and thereby venous pressures in the lower extremities. With limited treatments for valvular incompetence involved in severe, deep venous CVI, the device may be considered as a novel therapy. A pivotal trial in the United States is currently being conducted to assess the device in a larger number of patients.

An Implantable Bioprosthetic Venous Valve to Establish Deep Vein Competence for Post-Thrombotic Syndrome.

This article discusses the VenoValve bioprosthetic device, which is designed to improve valvular competence in the deep venous system of the lower extremities and treat deep venous insufficiency.

Painful ejaculation in a patient with pelvic venous insufficiency.

Pelvic venous insufficiency (PVI) is common in women but has been rarely diagnosed in men. The clinical manifestations include varicocele and pelvic disturbances; however, we were unable to find a previous description of painful ejaculation as a symptom of PVI. We present the case of a 36-year-old man with a 7-year history of severe sharp ejaculatory pain. PVI was suspected after previous treatment attempts. The diagnosis was confirmed by descending phlebography, and he underwent coil embolization of the pelvic vessels and phlebotonic therapy. At 6 months after treatment, he reported a 75% improvement in his condition. Therefore, painful ejaculation should be considered an uncommon manifestation of PVI.

Angiotomografía en la evaluación de arterias perforantes para reconstrucción mediante colgajos: lo que el cirujano quiere saber y el radiólogo debe informar / Computed tomography angiography for perforator flaps: What the surgeon needs to know and the radiologist should inform

Resumen Desde la introducción del concepto de «angiosomas¼ se describieron las arterias perforantes y su potencial para el uso en colgajos. La angiotomografía es un método excelente para la valoración preoperatoria en cirugías reconstructivas y es clave en la valoración prequirúrgica. Es un estudio multidisciplinario en cuyo análisis participan el radiólogo y el cirujano plástico. Es importante incluir en el reporte radiológico el origen de la arteria, detallar su curso, cuantificar el calibre y determinar su emergencia para facilitar al cirujano la planeación prequirúrgica y la realización del procedimiento quirúrgico. Otra de las principales ventajas es que el uso de este método disminuye los tiempos quirúrgicos y las posibles complicaciones de las cirugías reconstructivas. El radiólogo debe estar familiarizado con los tipos de colgajos más comúnmente utilizados, la anatomía de las arterias y sus perforantes para guiar al cirujano en la planeación prequirúrgica y la toma de decisiones.

Abstract Since the introduction of the concept of "angiosomes", the perforating arteries and their potential for use in flaps was described. Angiotomography is an excellent imaging modality for preoperative evaluation in reconstructive surgery and is very important in presurgical assessment. This imaging technique requires a multidisciplinary approach in which the radiologist and the plastic surgeon participate. The radiological report must include the origin of the artery, detail it's course, quantify the caliber and determine the position where it emerges through the fascial plane to give the surgeon the possible information in presurgical planning and surgical procedure. The main advantage of this technique is the reduction of surgical timing and possible complications. The radiologist should be familiar with the most commonly used types of flaps, the anatomy of the arteries and their perforators to guide the plastic surgeon in presurgical planning and decision making.

Curación de úlceras venosas crónicas inducida con un hidrogel de aloe vera, sorbitol, alantoína y glicerol.

OBJETIVO: Evaluar la eficacia de un hidrogel compuesto con aloe vera, sorbitol, alantoína y glicerol, y estudiar clínicamente los niveles de interleucina 6 (IL-6) para el tratamiento de úlceras venosas (UV). MÉTODO: Se realizó un ensayo clínico no aleatorizado de un solo brazo en 10 sujetos. Cada sujeto fue tratado con el hidrogel durante ocho semanas. Tras completar el período de seguimiento, se realizó una evaluación final de las puntuaciones clínicas y moleculares de cada paciente, que se comparó con los datos iniciales. RESULTADOS: Los pacientes tratados con el hidrogel presentaron una reducción media del área de la UV de -1,12 cm5 (±2,53), reducción media del volumen de -1,47 cm6 (±3,43) y valor medio de IL-6 perilesional de -1,81 pg/mL (±8,07). También, se encontró una reducción media de la puntuación de la gravedad clínica venosa (VCSSr) de -9,3 (±2,62) y de la puntuación del dolor en la escala visual analógica (VAS) de -5,5 (±2,22). CONCLUSIÓN: La IL-6 es un indicador molecular útil para la vigilancia de la cicatrización de heridas. El tratamiento con un hidrogel a base de aloe vera, sorbitol y alantoína favorece la cicatrización de la herida, mejora la calidad de vida y reduce los niveles de dolor de la UV. CONFLICTO DE INTERÉS: El investigador principal, Dr Jorge Ulloa, declara recepción de recursos para investigación por parte de Humany Care. Este proyecto fue financiado por Humany Care.