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OBJECTIVE: The Human Acellular Vessel (HAV) is a novel, off-the-shelf biologic conduit being evaluated for arterial reconstructions. Regulatory studies in peripheral arterial disease (PAD) to date have consisted of single-arm cohorts with no comparator groups to contrast performance against established standards. This study aimed to compare outcomes of the HAV with autologous great saphenous vein (GSV) in patients with advanced PAD undergoing infrageniculate bypass. METHODS: Patients with advanced PAD and no autologous conduit who underwent bypass with the 6-mm diameter HAV (Group 1; n = 34) (March 2021-February 2024) were compared with a multicenter historical cohort who had bypass with single-segment GSV (group 2; n = 88) (January 2017-December 2022). The HAV was used under an Investigational New Drug protocol issued by the Food and Drug Administration (FDA) under the agency's Expanded Access Program. RESULTS: Demographics were comparable between groups (mean age 69 ± 10 years; 71% male). Group 1 had higher rates of tobacco use (37 pack-years vs 28 pack-years; P = .059), coronary artery disease (71% vs 43%; P = .007), and prior coronary artery bypass grafting (38% vs 14%; P = .003). Group 1 had more patients classified as wound, ischemia, and foot infection clinical stage 4 (56% vs 33%; P = .018) and with previous index leg revascularizations (97% vs 53%; P < .001). Both groups had a similar number of patients with chronic limb-threatening ischemia (Rutherford class 4-6) (88% vs 86%; P = .693) and Global Anatomic Staging System stage III (91% vs 96%; P = .346). Group 1 required a composite conduit (two HAV sewn together) in 85% of bypasses. The tibial vessels were the target in 79% of group 1 and 100% of group 2 (P < .001). Group 1 had a lower mean operative time (364 minutes vs 464 minutes; P < .001). At a median of 12 months, major amputation-free survival (73% vs 81%; P = .55) and overall survival (84% vs 88%; P = .20) were comparable. Group 1 had lower rates of primary patency (36% vs 50%; P = .044), primary-assisted patency (45% vs 72%; P = .002), and secondary patency (64% vs 72%; P = .003) compared with group 2. CONCLUSIONS: Implanted under Food and Drug Administration Expanded Access provisions, the HAV was more likely to be used in redo operations and cases with more advanced limb ischemia than GSV. Despite modest primary patency, the HAV demonstrated resilience in a complex cohort with no autologous conduit options, achieving good secondary patency and providing major amputation-free survival comparable with GSV at 12 months.
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OBJECTIVE: Type B intramural hematoma (IMH) is often managed medically, yet may progress to dissection, aneurysmal dilation, or rupture. The aim of this study was to report the natural history of medically managed Type B IMH, and factors associated with progression. METHODS: We reviewed patients with medically managed Type B IMH between January 1995 to December 2022 at a single center. Any patients with immediate surgical or endovascular intervention were excluded. Demographic profiles, comorbidities, imaging, and follow-up details were reviewed. Patients were divided into two groups: Group 1 had isolated IMH, and Group 2 had IMH along with aneurysm or dissection at the time of presentation. On follow-up, progression was defined as degeneration to aneurysm/dissection or increase in the thickness of IMH in Group 1. In Group 2, progression was an increase in the size of aneurysm or development of new dissection. RESULTS: Of 104 patients with Type B IMH during the study period, 92 were medically managed. The median age was 77 years, and 45 (48.9%) were females. Comorbidities included hypertension (83.7%), hypercholesterolemia (44.6%), and active smoking (47.8%). Mean Society for Vascular Surger comorbidity score was 6.3. Mean IMH thickness and aortic diameter at presentation were 8.9 mm and 38.3 mm, respectively. Median follow-up was 55 months. Overall survival at 1 year and 5 years was 85.8% and 61.9%, respectively. During follow-up, 19 patients (20.7%) required intervention, more common in Group 2 (Group 1, 8/66; 12.3% vs Group 2, 11/26; 42.3%; P = .001). This resulted in higher freedom from intervention in Group 1 at 1 year (93.5% vs 62.7%) and 5 years (87.5% vs 51.1%; P < .001). Indication for intervention was dissection (n = 4), aneurysm (n = 12), and progression of IMH (n = 3). In Group 1, progression was seen in 25 (37.9%), three (4.5%) remained stable, 29 (43.9%) had complete resolution of IMH, and nine patients were lost to follow-up. In Group 2, 11 patients (42.3%) had progression, seven (26.9%) remained stable, and eight were lost to follow-up. IMH thickness at presentation >7.2 mm is associated with both increased odds of progression (odds ratio, 3.3; 95% confidence interval, 1.2-11.1; P = .03) and intervention (odds ratio, 5.5; 95% confidence interval, 1.3-36.9; P = .03) during the follow-up. CONCLUSIONS: Although many patients with Type B IMH managed medically stabilize or regress, progression or need for intervention can occur in up to 40% of cases. This is associated with the presence of aneurysm, dissection, and IMH thickness. Long-term follow-up is mandatory as late interventions occur, particularly for higher risk patients.
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Disección Aórtica , Progresión de la Enfermedad , Hematoma , Humanos , Femenino , Masculino , Hematoma/diagnóstico por imagen , Hematoma/terapia , Hematoma/mortalidad , Anciano , Estudios Retrospectivos , Factores de Tiempo , Factores de Riesgo , Disección Aórtica/diagnóstico por imagen , Disección Aórtica/terapia , Disección Aórtica/mortalidad , Anciano de 80 o más Años , Persona de Mediana Edad , Resultado del Tratamiento , Medición de Riesgo , Rotura de la Aorta/diagnóstico por imagen , Rotura de la Aorta/mortalidad , Rotura de la Aorta/cirugía , Rotura de la Aorta/terapiaRESUMEN
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.
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Aneurisma de la Aorta Abdominal , Endofuga , Reparación Endovascular de Aneurismas , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/mortalidad , Endofuga/etiología , Endofuga/mortalidad , Endofuga/terapia , Endofuga/diagnóstico por imagen , Reparación Endovascular de Aneurismas/efectos adversos , Reparación Endovascular de Aneurismas/mortalidad , Reoperación , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
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.
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Implantación de Prótesis Vascular , Enfermedad Arterial Periférica , Masculino , Humanos , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Isquemia Crónica que Amenaza las Extremidades , Implantación de Prótesis Vascular/efectos adversos , Grado de Desobstrucción Vascular , Resultado del Tratamiento , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/cirugía , Factores de Riesgo , Extremidad Inferior/irrigación sanguínea , Isquemia/diagnóstico por imagen , Isquemia/cirugía , Recuperación del Miembro/métodos , Estudios RetrospectivosRESUMEN
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.
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Cuidados Posteriores , Implantación de Prótesis Vascular , Humanos , Anciano , Estudios Retrospectivos , Reinfección , Resultado del Tratamiento , Alta del Paciente , Aloinjertos , Grado de Desobstrucción Vascular , Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Vena Safena/trasplante , Factores de RiesgoRESUMEN
Autologous vein is the optimal conduit for peripheral arterial bypass surgery, a standard recently highlighted by findings from the BEST-CLI trial. The Human Acellular Vessel is a novel biologic conduit produced using regenerative medicine technologies with structural and mechanical properties like a human blood vessel. Not yet approved by the United States Food and Drug Administration, the Human Acellular Vessel is being studied as an alternative bypass conduit in patients with peripheral arterial disease, vascular injury, and those in need of arteriovenous access for hemodialysis. This report describes and illustrates the technical aspects of intraoperative handling specific to the use of this new and innovative technology.
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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.
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Implantación de Prótesis Vascular , Infecciones Relacionadas con Prótesis , Humanos , Anciano , Rifampin/efectos adversos , Tereftalatos Polietilenos , Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Reinfección , Estudios Retrospectivos , Cuidados Posteriores , Infecciones Relacionadas con Prótesis/diagnóstico , Infecciones Relacionadas con Prótesis/cirugía , Resultado del Tratamiento , Alta del Paciente , Factores de Riesgo , Aloinjertos/cirugíaRESUMEN
Type B aortic dissection (TBAD) in the presence of an existing aortic endograft is a rare, but potentially catastrophic, event. False lumen pressurization and propagation leads to several failure modes. Endograft collapse can lead to spinal cord, visceral, or lower extremity ischemia, and rupture of a previously sealed aneurysm sac is often fatal. A successful treatment strategy must incorporate the patient's symptoms, urgency of intervention, extent of dissection, and the location and status of the existing graft. In this series, we present three cases of TBAD complicating prior endovascular aortic repairs-infrarenal, iliac branched, and thoracoabdominal branched endografts-successfully treated with tailored, hybrid interventions.
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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.
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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.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Aneurisma Ilíaco , Humanos , Persona de Mediana Edad , Anciano , Rifampin/efectos adversos , Aneurisma Ilíaco/diagnóstico por imagen , Aneurisma Ilíaco/cirugía , Tereftalatos Polietilenos , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Reinfección , Resultado del Tratamiento , Factores de Riesgo , Aloinjertos/cirugía , Estudios Retrospectivos , Aneurisma de la Aorta Abdominal/cirugíaRESUMEN
BACKGROUND: Retrograde open mesenteric stenting (ROMS) has become a mainstay in treatment of mesenteric ischemia; however, follow-up in contemporary studies is limited. METHODS: A single-center retrospective review of patients undergoing ROMS from 2007 to 2020 was conducted. Demographics, presentation, and procedural details were reviewed. End points were morbidity and mortality, technical success, primary patency, reinterventions, and freedom from clinical recurrence. RESULTS: ROMS was performed in 34 patients, 19 female (56%). Mean age was 71 ± 10 years. Eighteen patients (53%) presented with acute mesenteric ischemia (AMI), 11 (32%) with acute-on-chronic, and 5 (15%) with chronic mesenteric ischemia. Etiology was chronic atherosclerosis with/without in-situ thrombosis in 28 patients (82%), superior mesenteric artery dissection in 3, and 1 each with embolic, vasculitic, and nonocclusive ischemia. Four patients (12%) had prior mesenteric procedures (3 Celiac/1 superior mesenteric artery stent) and 1 had unsuccessful transbrachial stenting attempt. Technical success, defined as successful stenting through a retrograde approach was attained in 31 patients (91%), with the 3 remaining patients treated with transbrachial stenting in 2 and iliomesenteric bypass in 1. Covered stents were used in 21 patients (64%) with or without stent extension with bare-metal stents. Eight patients (23%) required thromboembolectomy and 9 (26%) underwent patch angioplasty. Thirty-day mortality rate was 35%, all in patients with AMI (10) or acute-on-chronic (2). Eighteen patients (53%) underwent bowel resection, all presenting acutely. Early reinterventions within the first 30 days were required in 5 patients (15%), including 2 redo ROMS with thrombectomy and endarterectomy, 2 percutaneous stent extensions, and 1 aortic septum fenestration with coiling of a jejunal branch pseudoaneurysm. With a median follow-up of 3.7 (interquartile range: 0.8-5.0) years, in patients surviving discharge, 5 required reintervention yielding freedom from reintervention rates of 87% at 1 year and 71% at 3 years. All postdischarge reinterventions were endovascular with no conversion to bypass. The overall 1-year and 3-year primary patency rates were 70% and 61% (primary-assisted patency at 1 and 3 years was 87% and secondary patency at 1 and 3 years was 97%). The freedom from symptom recurrence was 95% at 1 and 3 years. CONCLUSIONS: ROMS carries high rates of technical success in patients with mesenteric ischemia, despite a high chronic atherosclerotic burden. Although mid-term patency rates are acceptable, AMI is still associated with high early morbidity and mortality, with high rates of associated bowel resection. ROMS is a valuable tool in the armamentarium of vascular surgeons.
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Aterosclerosis , Isquemia Mesentérica , Humanos , Femenino , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Isquemia Mesentérica/diagnóstico por imagen , Isquemia Mesentérica/cirugía , Cuidados Posteriores , Resultado del Tratamiento , Alta del Paciente , Isquemia/diagnóstico por imagen , Isquemia/cirugía , Stents/efectos adversosRESUMEN
OBJECTIVE: The aim of this study was to analyze malpractice claims for aortic pathologies and to assess if there has been a change in rate of malpractice lawsuits with evolution of endovascular therapy. METHODS: Malpractice lawsuits were individually screened and compiled from the Westlaw database from 2000 to 2017 through use of relevant search terms. Data were collected of allegations, diagnoses, and outcomes of each case and compared. RESULTS: 268 unique cases were included in this study, with aneurysms (54%, n = 145) and dissection (35%, n = 94) making up the majority. There was a defendant verdict in 53% (n = 141), plaintiff verdict in 24% (n = 65), and settlements in 23% (n = 62) of lawsuits. Litigation was higher in the Midwest and Northeast. There was a gradual decline in litigation overall, however endovascular case numbers remained constant. There was negligible difference in the primary allegation underlying the litigation for various aortic pathologies, time to litigation and award between open and endovascular procedures. CONCLUSION: The proportion of litigation for clinical negligence in endovascular cases amongst all vascular surgical lawsuits is increasing. As novel methods of endovascular therapy emerge, it is imperative that physicians remain vigilant to legal considerations to minimize malpractice risk.
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Procedimientos Endovasculares , Mala Praxis , Cirujanos , Humanos , Estados Unidos , Resultado del Tratamiento , Procedimientos Endovasculares/efectos adversos , Bases de Datos FactualesRESUMEN
OBJECTIVE: The aim of the present study was to evaluate the presentation trends, intervention, and survival of patients who had been treated for late abdominal aortic aneurysm rupture (LAR) after open repair (OR) or endovascular aortic aneurysm repair (EVAR). METHODS: We reviewed the clinical data from a single-center, retrospective database for patients treated for LAR from 2000 to 2020. The end points were the 30-day mortality, major postoperative complication, and survival. The outcomes between LAR managed with EVAR (group I) vs OR were compared (group II). RESULTS: Of 390 patients with infrarenal aortic rupture, 40 (10%) had experienced aortic rupture after prior aortic repair and comprised the LAR cohort (34 men; age 78 ± 8 years). LAR had occurred before EVAR in 30 and before OR in 10 patients. LAR was more common in the second half of the study with 32 patients after 2010. LAR after prior OR was secondary to ruptured para-anastomotic pseudoaneurysms. After initial EVAR, LAR had occurred despite reintervention in 17 patients (42%). The time to LAR was shorter after prior EVAR than after OR (6 ± 4 vs 12 ± 4 years, respectively; P = .003). Treatment for LAR was EVAR for 25 patients (63%; group I) and OR for 15 (37%, group II). LAR after initial OR was managed with endovascular salvage for 8 of 10 patients. Endovascular management was more frequent in the latter half of the study period. In group I, fenestrated repair had been used for seven patients (28%). Salvage for the remaining cases was feasible with EVAR, aortic cuffs, or limb extensions. The incidence of free rupture, time to treatment, 30-day mortality (8% vs 13%; P = .3), complications (32% vs 60%; P = .1), and disposition were similar between the two groups. Those in group I had had less blood loss (660 vs 3000 mL; P < .001) and less need for dialysis (0% vs 33%; P < .001) than those in group II. The median follow-up was 21 months (interquartile range, 6-45 months). The overall 1-, 3-, and 5-year survival was 76%, 52%, and 41%, respectively, and was similar between groups (28 vs 22 months; P = .48). Late mortality was not related to the aorta. CONCLUSIONS: LAR after abdominal aortic aneurysm repair has been encountered more frequently in clinical practice, likely driven by the frequency of EVAR. However, most LARs, including those after previous OR, can now be salvaged with endovascular techniques with lower morbidity and mortality.
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Aneurisma de la Aorta Abdominal , Rotura de la Aorta , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Masculino , Humanos , Anciano , Anciano de 80 o más Años , Implantación de Prótesis Vascular/efectos adversos , Estudios Retrospectivos , Rotura de la Aorta/diagnóstico por imagen , Rotura de la Aorta/etiología , Rotura de la Aorta/cirugía , Procedimientos Endovasculares/efectos adversos , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/terapia , Complicaciones Posoperatorias/epidemiología , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/etiología , Resultado del Tratamiento , Factores de RiesgoRESUMEN
PURPOSE: The aim of the study was to evaluate outcomes after bilateral implantation of the Gore Excluder Iliac Branch Endoprosthesis (IBE) versus those achieved after unilateral implantation. METHODS: All consecutive patients electively treated in a single center for aorto-iliac aneurysm using the IBE device between January 1, 2014, and December 31, 2018, were reviewed. Early outcome measures were technical success, 30 days or in-hospital mortality, and major adverse events (MAE). Late outcome measures were survival, internal iliac artery (IIA) patency, and freedom from IIA branch instability. RESULTS: A total of 74 patients (97% males, mean age 74 ± 7 years) were included. Thirteen patients (17%) received bilateral IBE implantation for a total of 85 vessels evaluated. The technical success rate was 97% and was not significantly different between the two groups (p = .32). Two patients died within 30 days, both in the unilateral group (p = 1). No significant differences were seen in the rates of 30 days MAE (p = .10). At one year, the overall survival rate was 95 ± 2% vs 90 ± 3% in the unilateral and bilateral group, respectively (Log-rank = .05). There were no differences in 1-year primary and secondary patency rates between groups (Log-rank = .75 and Log-rank = .34, respectively). Freedom from IIA branch instability at one year was also not significantly different (unilateral: 94 ± 3% vs. bilateral: 82 ± 9%, Log-rank = .22).. CONCLUSIONS: Bilateral IBE use for elective endovascular treatment of aorto-iliac aneurysms appears safe and feasible and may achieve satisfactory short-term and mid-term outcomes. Bilateral IBE use should be employed judiciously in the context of a comprehensive risk/benefit evaluation.
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Implantación de Prótesis Vascular , Procedimientos Endovasculares , Aneurisma Ilíaco , Anciano , Anciano de 80 o más Años , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Femenino , Humanos , Aneurisma Ilíaco/diagnóstico por imagen , Aneurisma Ilíaco/cirugía , Masculino , Diseño de Prótesis , Estudios Retrospectivos , Stents , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
OBJECTIVE: Arterial thoracic outlet syndrome (ATOS) is rare. We present our 30-year experience with the management of ATOS at a high-volume referral center. METHODS: A retrospective review of all patients who had undergone primary operative treatment for ATOS from 1988 to 2018 was performed. ATOS was defined as subclavian artery pathology caused by extrinsic compression from a bony abnormality within the thoracic outlet. RESULTS: A total of 41 patients (45 limbs) underwent surgery for ATOS at a median age of 46 years (interquartile range [IQR], 34-58 years). Chronic symptoms (>6 weeks) were present in 31 limbs (69%). Of the 45 limbs, 13 (29%) presented with acute limb ischemia (ALI), requiring urgent brachial artery thromboembolectomy (BAT) in 9 and catheter-directed thrombolysis and thrombectomy (CDT) in 4. All patients underwent thoracic outlet decompression. 31 limbs (69%) required subclavian artery reconstruction. No perioperative deaths and only one major adverse limb event occurred. Patients with ALI underwent staged thoracic outlet decompression after initial BAT or CDT at a median of 23 days (IQR, 11-140 days). Of the 13 limbs with an initial presentation of ALI, 8 (62%) had recurrent thromboembolic events before thoracic outlet decompression subsequently requiring 10 additional BATs and 1 CDT. The cumulative probability of recurrent embolization at 14, 30, and 90 days was 8.33% (95% confidence interval [CI], 1.28%-54.42%), 16.67% (95% CI, 4.70%-59.06%), and 33.33% (95% CI, 14.98-74.20%), respectively. The median follow-up for 32 patients (35 limbs) was 13 months (IQR, 5-36 months). Subclavian artery/graft primary and secondary patency was 87% and 90%, respectively, at 5 years by Kaplan-Meier analysis. Of the 35 limbs, 5 (14%) had chronic upper extremity pain and 5 (14%) had persistent weakness. Preoperative forearm or hand pain and brachial artery occlusion were associated with chronic pain (P = .04 and P = .03) and weakness (P = .03 and P = .02). Of the 13 limbs that presented with ALI, 11 had a median follow-up after thoracic outlet decompression of 6 months (IQR, 5-14 months), including 9 (82%) with oral anticoagulation therapy. Anticoagulation therapy had no effect on subclavian artery patency (P = 1.0) or the presence of chronic symptoms (P = .93). CONCLUSIONS: The presentation of ATOS is diverse, and the diagnosis can be delayed. Preoperative upper extremity pain and brachial artery occlusion in the setting of ALI were associated with chronic pain and weakness after thoracic outlet decompression. Delayed thoracic outlet decompression was associated with an increased risk of recurrent thromboembolic events for patients who presented with ALI. An early and accurate diagnosis of ATOS is necessary to reduce morbidity and optimize outcomes.
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Arteriopatías Oclusivas , Dolor Crónico , Síndrome del Desfiladero Torácico , Adulto , Anticoagulantes , Arteriopatías Oclusivas/cirugía , Descompresión Quirúrgica/efectos adversos , Humanos , Isquemia/diagnóstico por imagen , Isquemia/cirugía , Persona de Mediana Edad , Estudios Retrospectivos , Arteria Subclavia/diagnóstico por imagen , Arteria Subclavia/cirugía , Síndrome del Desfiladero Torácico/diagnóstico , Síndrome del Desfiladero Torácico/diagnóstico por imagen , Resultado del TratamientoRESUMEN
OBJECTIVE: Aneurysms of the superior mesenteric artery (SMA) and its branches are rare and account for only 6% to 15% of all visceral artery aneurysms. In the present report, we have described our 30-year experience with the management of aneurysms of the SMA and its branches at a high-volume referral center. METHODS: A retrospective review of all patients with a diagnosis of an aneurysm of the SMA or one of its branches from 1988 to 2018 was performed. Pseudoaneurysms and mycotic aneurysms were excluded. The clinical presentation, etiology, aneurysm shape and size, treatment modalities, and outcomes were analyzed. The growth rate of the aneurysms was estimated using linear regression. RESULTS: A total of 131 patients with 144 aneurysms were reviewed. The patients were primarily men (64%), with a median age of 60 years. Of the 144 aneurysms, 57 were fusiform, 30 were saccular, and 57 were dissection-associated aneurysms. Of the 131 patients, 41 had had an isolated SMA branch aneurysm. Degenerative aneurysms were the most common etiology (66%). A total of 35 patients (27%) were symptomatic at presentation. Of the 144 aneurysms, 111 had multiple computed tomography angiograms available, with a median follow-up of 43.6 months (interquartile range, 10.6-87.2 months). Only 18 aneurysms (16%) had had an estimated growth rate of ≥1.0 mm/y. The initial aneurysm size was significantly associated with the growth rate for the fusiform aneurysms (odds ratio [OR], 1.13; 95% confidence interval [CI], 1.0-1.3]; P = .02) but not for the saccular (OR, 0.91; 95% CI, 0.76-1.1; P = 1.1) or dissection-associated (OR, 1.2; 95% CI, 0.91-1.5; P = .20) aneurysms. Acute abdominal pain (OR, 5.9; 95% CI, 1.6-22; P = .01) and chronic abdominal pain (OR, 3.7; 95% CI, 1.1-13; P = .04) were associated with aneurysm growth. Only two patients had a ruptured aneurysm, both of whom presented with rupture with no prior imaging studies. These two patients had a diagnosis of fibromuscular dysplasia and systemic lupus erythematosus, respectively. Of the 131 patients, 46 (34%) had undergone operative repair, including 36 open revascularizations and 8 endovascular procedures. The average aneurysm size for these 46 patients was 24.0 ± 8.6 mm. One patient died perioperatively, and nine patients experienced perioperative complications (25%). Of the 144 aneurysms, 91 were <20 mm, with an average size of 13.4 ± 3.1 mm. These 91 aneurysms had been followed up for a median of 120.8 months (interquartile range, 30.5-232.2 months), with no ruptures within this cohort during the follow-up period. CONCLUSIONS: The present study represents one of the largest series on aneurysms of the SMA and its branches. Our results showed that aneurysms of the SMA are relatively stable. Patients with symptomatic and fusiform aneurysms had a greater risk of growth. Aneurysms <20 mm with a degenerative etiology can be safely monitored without treatment.
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Aneurisma Roto , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Dolor Abdominal/cirugía , Aneurisma Roto/cirugía , Procedimientos Endovasculares/efectos adversos , Humanos , Masculino , Arteria Mesentérica Superior/diagnóstico por imagen , Arteria Mesentérica Superior/cirugía , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: We aimed to assess the effect of surgeons' shunting practice and shunt use on the early outcomes of carotid endarterectomy (CEA) in recently symptomatic patients. METHODS: We conducted a retrospective observational study based on a multicenter national prospective database. The Vascular Quality Initiative database (2010-2019) was queried for CEAs performed within 14 days after an ipsilateral stroke or transient ischemic attack. Surgeons were gauged as routine shunters if they shunted in >95% of CEAs, otherwise were classified as selective shunters. In-hospital stroke and death rates were compared between routine and selective shunters, stratifying by type of index event (transient ischemic attack versus stroke) and timing of CEA (≤2 versus >2 days). RESULTS: Thirteen thousand four hundred sixty-nine CEAs were performed after a transient ischemic attack (43%) or stroke (57%), 3186 (24%) by routine shunters, and 10 283 (76%) by selective shunters. Comparing routine and selective shunters, in-hospital stroke (1.9% versus 2.4%; P=0.09) and death (0.4% versus 0.5%; P=0.73) rates were similar. A lower stroke rate (1.5% versus 4.2%; P=0.02) was achieved by routine shunters for CEA performed <2 days after an ischemic stroke. Among selective shunters, a higher stroke rate occurred in case of shunt use (2.9% versus 2.3%; P<0.01), mainly due to cases presenting with stroke (3.5% versus 2.4%; P<0.01) but not transient ischemic attack (1.8% versus 1.5%; P=0.57). Awake anesthesia was adopted in 7.8% of cases by selective shunters and in 0.8% by routine shunters, without impact on the perioperative stroke rate (1.8% versus 2.3%; P=0.349). CONCLUSIONS: In this large national cohort, the overall outcomes of CEA were similar between routine and selective shunters. A lower postoperative stroke rate was achieved by routine shunters in CEA performed <2 days after an ischemic stroke. Among selective shunters, intraoperatively indicated shunting determined an increased stroke rate, likely due to intraoperative hypoperfusion. These data may guide the decision regarding timing of CEA and shunting intention in symptomatic patients.
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Estenosis Carotídea , Endarterectomía Carotidea , Ataque Isquémico Transitorio , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Estenosis Carotídea/complicaciones , Estenosis Carotídea/cirugía , Humanos , Ataque Isquémico Transitorio/epidemiología , Ataque Isquémico Transitorio/cirugía , Estudios Retrospectivos , Factores de Riesgo , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Factores de Tiempo , Resultado del TratamientoRESUMEN
PURPOSE: The purpose of this study was to compare outcomes of internal iliac artery (IIA) stenting using balloon-expandable (BESG) or self-expandable stent grafts (SESG) during endovascular repair of aortoiliac aneurysms with iliac branch endoprosthesis (IBE; W. L. Gore, Flagstaff, Ariz). METHODS: We retrospectively reviewed all consecutive patients treated for aortoiliac aneurysms using IBE between 2014 and 2020. IIA stenting was performed using either the IIA side branch SESG or a Gore VBX BESG (W. L. Gore). Indications for use of BESGs were "up-and-over" IBE technique for type IB endoleak after prior endovascular aortic aneurysm repair (EVAR), short IIA length, and need for IIA extension into divisional branches (outside instructions for use). End points included technical success, freedom from buttock claudication, primary IIA patency, and freedom from IIA branch instability (eg, branch-related death or rupture, occlusion, disconnection, or reintervention for stenosis, kink, or endoleak), freedom from type IC/IIIC endoleak, and freedom from secondary interventions. RESULTS: There were 90 patients (86 males and 4 females) with a mean age of 74 ± 7 years treated by EVAR with 108 IBEs. Choice of stent was BESG in 43 and SESG in 65 targeted IIAs. BESGs were used more frequently in patients with prior EVAR (22% vs 2%; P = .003,), isolated IBEs (31% vs 2%; P < .001), and in patients with IIA aneurysms requiring stenting into divisional branches (36% vs 5%; P < .001). Technical success was similar for BESGs and SESGs (97% vs 100%; P = .40), respectively. The mean follow-up was 25 ± 16 months (range, 11-34 months). At 2 years, freedom from buttock claudication was 100% for BESG and 95 ± 3% for SESG (Log-rank 0.26), with no difference in primary patency (BESG, 100% vs SESG, 94 ± 4%; Log-rank 0.94). There were four (9%) IIA-related endoleaks in the BESG group and one (2%) in the SESG group (P = .08). Freedom from IIA branch instability was 87 ± 6% for BESG and 96 ± 3% for SESG at 2 years (Log-rank 0.043). Freedom from type IC/IIIC endoleak was 87 ± 7% for BESG and 98 ± 2% for SESG at the same interval (Log-rank 0.06). There was no difference in freedom from reinterventions for BESG and SESG (92 ± 6% vs 98 ± 2%; Log-rank 0.34), respectively. CONCLUSIONS: BESGs were used more frequently during IBE procedures indicated for failed EVAR, isolated common iliac aneurysms, and IIA aneurysms requiring extension into divisional branches. Despite these differences and BESG being used outside instructions for use, both stent types had similar primary patency, freedom from buttock claudication, and freedom from reinterventions. However, BESGs were associated with higher rates of IIA-related branch instability.
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Implantación de Prótesis Vascular , Procedimientos Endovasculares , Aneurisma Ilíaco , Anciano , Anciano de 80 o más Años , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Endofuga/terapia , Procedimientos Endovasculares/efectos adversos , Femenino , Humanos , Aneurisma Ilíaco/diagnóstico por imagen , Aneurisma Ilíaco/etiología , Aneurisma Ilíaco/cirugía , Claudicación Intermitente/etiología , Masculino , Diseño de Prótesis , Estudios Retrospectivos , Factores de Riesgo , Stents , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
Senescent cells (SNCs) degenerate the fibrous cap that normally prevents atherogenic plaque rupture, a leading cause of myocardial infarction and stroke. Here we explored the underlying mechanism using pharmacological or transgenic approaches to clear SNCs in the Ldlr -/- mouse model of atherosclerosis. SNC clearance reinforced fully deteriorated fibrous caps in highly advanced lesions, as evidenced by restored vascular smooth muscle cell (VSMC) numbers, elastin content, and overall cap thickness. We found that SNCs inhibit VSMC promigratory phenotype switching in the first interfiber space of the arterial wall directly beneath atherosclerotic plaque, thereby limiting lesion entry of medial VSMCs for fibrous cap assembly or reinforcement. SNCs do so by antagonizing IGF-1 through the secretion of insulin-like growth factor-binding protein 3 (Igfbp3). These data indicate that the intermittent use of senolytic agents or IGFBP-3 inhibition in combination with lipid lowering drugs may provide therapeutic benefit in atherosclerosis.