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Vascular graft infection (VGI) is one of the most serious complications following arterial reconstructive surgery. VGI has received increasing attention over the past decade, but many questions remain regarding its diagnosis and management. In this review, we describe our approach to VGI through multidisciplinary collaboration and discuss decision-making for challenging presentations. This document will concentrate on VGI that impacts both aneurysms and pseudoaneurysms excluding the ascending thoracic aorta.
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Procedimientos de Cirugía Plástica , Infecciones Relacionadas con Prótesis , Humanos , Prótesis Vascular/efectos adversos , Grupo de Atención al Paciente , Procedimientos de Cirugía Plástica/métodos , Procedimientos de Cirugía Plástica/efectos adversos , Infecciones Relacionadas con Prótesis/cirugía , Injerto Vascular/efectos adversos , Literatura de Revisión como AsuntoRESUMEN
Vascular graft infection (VGI) is one of the most serious complications following arterial reconstructive surgery. VGI has received increasing attention over the past decade, but many questions remain regarding its diagnosis and management. In this review, we describe our approach to VGI through multidisciplinary collaboration and discuss decision making for challenging presentations. This review will concentrate on VGI that impacts both aneurysms and pseudoaneurysms excluding the ascending thoracic aorta.
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Procedimientos de Cirugía Plástica , Infecciones Relacionadas con Prótesis , Humanos , Procedimientos de Cirugía Plástica/métodos , Procedimientos de Cirugía Plástica/efectos adversos , Infecciones Relacionadas con Prótesis/cirugía , Prótesis Vascular/efectos adversos , Grupo de Atención al Paciente , Aneurisma Falso/cirugía , Aneurisma Falso/etiología , Arterias/cirugíaRESUMEN
OBJECTIVE: The aim of this study is to determine perioperative outcomes and the patency of interposition conduits for visceral arterial reconstruction in this setting. SUMMARY BACKGROUND DATA: Visceral arterial encasement in locally advanced pancreatic cancer was historically a contraindication for surgery. With modern effective neoadjuvant strategies, our recent experience has made advanced vascular resection and reconstruction feasible in selected patients. METHODS: A retrospective review was performed of patients undergoing pancreatic tumor resection with en bloc arterial resection and interposition revascularization between 6/2002-10/2022. Endpoints included graft patency, vascular-related complications, reinterventions, morbidity, and mortality. RESULTS: Visceral arterial reconstruction with interposition grafting was performed in 111 patients undergoing en bloc arterial resections for pancreatic cancer. Graft types included autologous arterial conduits (n=66, 58 superficial femoral artery (SFA) and 8 splenic artery), cryopreserved arterial allografts (n=24), autologous saphenous veins (n=12), synthetic conduits (n=8), and composite autologous artery and synthetic (n=1). Perioperative 90-day mortality decreased significantly over time to 5% in the last six years. Vascular complications related to arterial reconstruction occurred in 11% (n=12) and included pseudoaneurysm (n=6), graft thrombus (n=2), stenosis requiring reintervention (n=2), hepatic failure (n=1), and hepatic and intestinal ischemia (n=1). Nine (8%) patients underwent vascular-related reinterventions. After median follow-up of 17-months, primary patency was 81% for the entire cohort and was highest in the SFA group (95%). The donor limb/harvest site complication rate was 8% with 100% primary patency. CONCLUSION: Visceral arterial resection with interposition reconstruction for locally advanced pancreatic cancer can be performed with acceptable vascular morbidity and durable patency. Autologous SFA was the most suitable conduit for reconstructions in our experience, with highest primary patency.
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BACKGROUND: Nonhome discharge (NHD) has significant implications for patient counseling and discharge planning and is frequently required following fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms (CAAA) and thoracoabdominal aortic aneurysms (TAAA). We aimed to identify preoperative predictors of NHD after elective FB-EVAR for CAAA and TAAA and develop a risk calculator able to predict NHD. METHODS: A retrospective review of prospectively collected data on all patients undergoing FB-EVAR between January 2007 and December 2021 at a single institution was performed. Exclusion criteria were admission from a nonhome setting, emergency and repeat FB-EVAR, and discharge to an unknown destination. The cohort was randomly split into separate development (70% of patients) and validation (30%) cohorts to develop a predictive calculator for NHD. Independent variables associated with NHD were assessed in a series of logistic regression analyses from 100 bootstrapped samples of the development set, and a model was developed using the most predictive variables. Resulting parameter estimates were applied to data in the validation set to assess model discrimination and calibration. RESULTS: From the initial cohort of 712 FB-EVAR patients, 644 were included in the study (74% male; mean age, 75.4 ± 7.6 years), including 452 with CAAA (70%) and 192 with TAAA (30%). Early mortality occurred in eight patients (1.2%; 5 in CAAA and 3 in TAAA) and the median hospital stay was 5 days (4 for CAAA and 7 for TAAA). Ninety-seven patients (15%) had a NHD. On multivariable analysis, older age (per year, odds ratio [OR], 1.08; P < .001), female gender (OR, 3.03; P < .001), smoking (OR, 2.86; P = .01), congestive heart failure (OR, 3.05; P = .004), peripheral artery disease (OR, 1.81; P = .07), and extent I (OR, 3.17), II (OR, 2.84), and III (OR, 2.52; all P = .08) TAAAs were associated with an increased likelihood of NHD in the development set. Based on these factors, the risk calculator was developed which accurately predicts NHD in the validation set with an area under the curve of 0.7. CONCLUSIONS: Older, female smokers with congestive heart failure and peripheral artery disease and more extensive aneurysms are at highest risk of NHD after FB-EVAR. Using only preoperative factors, our risk calculator can predict accurately who will have a NHD, allowing enhanced preoperative patient counselling and accelerated hospital discharge.
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Aneurisma de la Aorta Abdominal , Aneurisma de la Aorta Toracoabdominal , Procedimientos Endovasculares , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Toracoabdominal/cirugía , Procedimientos Endovasculares/efectos adversos , Insuficiencia Cardíaca/cirugía , Alta del Paciente , Enfermedad Arterial Periférica/cirugía , Complicaciones Posoperatorias , Estudios Retrospectivos , Factores de Riesgo , Resultado del TratamientoRESUMEN
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
INTRODUCTION: Custom-branched/fenestrated grafts are widely available in other countries, but in the United States, they are limited to a handful of centers, with the exception of a 3-vessel juxtarenal device (ZFEN). Consequently, many surgeons have turned to alternative strategies such as physician-modified endografts (PMEGs). We therefore sought to determine how widespread the use of these grafts is. METHODS: We studied all complex endovascular repairs of complex and thoracoabdominal aortic aneurysms in the Vascular Quality Initiative from 2014 to 2022 to examine temporal trends. RESULTS: A total of 5826 repairs were performed during the study period: 1895 ZFEN, 3241 PMEG, 595 parallel grafting, and 95 where parallel grafting was used in addition to ZFEN, with a mean of 2.7 ± 0.98 vessels incorporated. Over time, the number of PMEGs steadily increased, both overall and for juxtarenal aneurysms, whereas the number of ZFENs essentially leveled off by 2017 and has remained steady ever since. In the most recent complete year (2021), PMEGs outnumbered ZFENs by over 2:1 overall (567 to 256) and nearly twofold for juxtarenal repairs. In three-vessel cases involving juxtarenal aneurysms, PMEGs were used as frequently as ZFENs (43% vs 43%), whereas the proportion of juxtarenal aneurysms repaired using a four-vessel graft configuration increased from 20% in 2014 to 29% in 2021 (P < .001). The differences in PMEG use were more pronounced as surgeon volume increased. Surgeons in the lowest quartile of volume performed <2 complex repairs annually, evenly split between PMEGs and ZFENs. However, surgeons in the highest quartile of volume performed a median of 18 (interquartile range: 10-21) PMEGs/y, but only 1.6 (interquartile range: 0.8-3.4) ZFENs/y. The number of physician-sponsored investigational device exemption trials of PMEGs has expanded from 1 in 2012 to 8 currently enrolling. As those data are not included in the Vascular Quality Initiative, the true number of PMEGs is likely substantially higher. CONCLUSIONS: PMEGs have become the dominant endovascular repair modality of complex abdominal and thoracoabdominal aortic aneurysms outside of investigational device exemptions. The field of endovascular aortic surgery and patients with complex aneurysms would benefit from broader publication of PMEG techniques, outcomes, and comparisons to custom-manufactured grafts.
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Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Prótesis Vascular , Procedimientos Endovasculares , Diseño de Prótesis , Humanos , Aneurisma de la Aorta Torácica/cirugía , Prótesis Vascular/tendencias , Procedimientos Endovasculares/tendencias , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Implantación de Prótesis Vascular/tendencias , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/efectos adversos , Estados Unidos , Factores de Tiempo , Resultado del Tratamiento , Pautas de la Práctica en Medicina/tendencias , Masculino , Estudios Retrospectivos , Femenino , Anciano , Bases de Datos Factuales , Sistema de Registros , Aneurisma de la Aorta ToracoabdominalRESUMEN
OBJECTIVE: The aim of this study was to identify trends in hospital length of stay (HLOS) and intensive care unit length of stay (ICULOS), and the relationship with cerebrospinal fluid drainage (CSFD) protocols in patients undergoing fenestrated-branched endovascular aortic repair (FB-EVAR) of thoracoabdominal aortic aneurysms (TAAAs). METHODS: A retrospective review of patients who underwent elective FB-EVAR for extent I to IV TAAAs between 2008 and 2023 at a single aortic center of excellence was conducted. Patient demographics, cardiovascular comorbidities, surgical risk, technical details, CSFD strategy (prophylactic or therapeutic), procedural success, and perioperative outcomes were collected. Patients were divided into two groups based on CSFD protocol. Group 1 included patients treated before 2020 when prophylactic CSFD was performed widely, and Group 2 consisted of patients treated since 2020 with therapeutic CSFD. Primary end points were HLOS, ICULOS, major adverse events, and perioperative mortality. RESULTS: FB-EVAR was performed in 702 patients; 412 underwent elective TAAA repair and were included in the analysis. Mean age was 73 ± 8 years and 68% were male. Patient-specific manufactured devices were used in 252 patients (61%), physician-modified endografts in 110 (27%), and 50 patients (12%) were treated with off-the-shelf devices. Demographics, aneurysm extent, major adverse events (including spinal cord ischemia [SCI]), and mortality were similar in both groups. A significant reduction in mean HLOS between the groups (9 ± 9 vs 6 ± 5 days; P = .02) coincided with decreased use of prophylactic CSFD (70% vs 1.2%; P < .001), with similar rates of SCI (7.6% vs 4.9%; P = .627) and ICULOS (3 ± 3 vs 2.5 ± 3; P = .19). Patients in the therapeutic drainage cohort (group 2) had a higher incidence of congestive heart failure (24% vs 11%; P = .003), hypercholesterolemia (91% vs 80%; P = .015), chronic obstructive pulmonary disease (55% vs 37%; P = .004), and peripheral artery disease (39% vs 19%; P < .001) compared with group 1, suggesting treatment of a more complex patient cohort. On adjusted multivariable analysis accounting for American Society of Anesthesiologists score, comorbidities, and device type, the difference in HLOS remained statistically significant (P = .01). CONCLUSIONS: HLOS decreased over time in patients undergoing FB-EVAR for TAAA after transition from a prophylactic to a therapeutic CSFD protocol. This transition was the only modifiable, independent risk factor for a shorter HLOS, without an increase in SCI, albeit with similar ICULOS.
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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: 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: 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 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 , Implantación de Prótesis Vascular , Endofuga , Procedimientos Endovasculares , Humanos , Endofuga/etiología , Endofuga/mortalidad , Endofuga/terapia , Endofuga/diagnóstico por imagen , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/mortalidad , Estudios Retrospectivos , Femenino , Masculino , Anciano , Factores de Tiempo , Factores de Riesgo , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Anciano de 80 o más Años , Medición de Riesgo , Resultado del Tratamiento , Reoperación , Reparación Endovascular de AneurismasRESUMEN
BACKGROUND: The aims of this study were: i) to assess fragility indices (FIs) of individual randomized controlled trials (RCTs) that compared paclitaxel-based drug-coated balloons (DCBs) or drug-eluting stents (DESs) versus standard endovascular devices, and ii) to meta-analyze mid-term and long-term safety and efficacy outcomes from available RCT data while also estimating the FI of pooled results. METHODS: This systematic review has been registered in the PROSPERO public database (CRD42022304326 http://www.crd.york.ac.uk/PROSPERO). A query of PubMed (Medline), EMBASE (Excerpta Medical Database), Scopus, and CENTRAL (Cochrane Central Register of Controlled Trials) databases was performed to identify eligible RCTs. Rates of primary patency (PP) and target lesion revascularization (TLR) were assessed as efficacy outcomes, while lower limb amputation (LLA) consisting of major amputation that is. below or above the knee and all-cause mortality were estimated as safety outcomes. All outcomes were pooled with a random effects model to account for any clinical and study design heterogeneity. The analyses were performed by dividing the RCTs according to their maximal follow-up length (mid-term was defined as results up to 2-3 years, while long-term was defined as results up to 4-5 years). For each individual outcome, the FI and reverse fragility index (RFI) were calculated according to whether the outcome results were statistically significant or not, respectively. The fragility quotient (FQ) and reverse fragility quotient (RFQ), which are the FI or RFI divided by the sample size, were also calculated. RESULTS: A total of 2,337 patients were included in the systematic review and meta-analysis. There were 2 RCTs examining DES devices and 14 RCTs evaluating different DCBs. For efficacy outcomes, there was evidence that paclitaxel-based endovascular therapy increased the PP rate and reduced the TLR rate at mid-term, with a calculated pooled risk ratio (RR) of 1.66 for patency (95% CI, 1.55-1.86; P < 0.001), with a corresponding number needed-to-treat (NNT) of 3 patients (95% CI, 2.9-3.8) and RR of 0.44 for TLR (95% CI, 0.35-0.54; P = 0.027), respectively. Similarly, there was evidence that paclitaxel-based endovascular therapy both increased PP and decreased TLR rates at long-term, with calculated pooled RR values of 1.73 (95% CI, 1.12-2.61; P = 0.004) and 0.53 (95% CI, 0.45-0.62; P = 0.82), respectively. For safety outcomes, there was evidence that paclitaxel-based endovascular therapy increased all-cause mortality at mid-term, with a calculated pooled RR of 2.05 (95% CI, 1.21-3.24). However, there was no difference between treatment arms in LLA at mid-term (95% CI, 0.1-2.7; P = 0.68). Similarly, neither all-cause mortality nor LLA at long-term differed between treatment arms, with a calculated pooled RR of 0.66, 1.02 (95% CI, 0.31-3.42) and 1.02 (95% CI, 0.30-5.21; P = 0.22), respectively. The pooled estimates of PP at mid-term were robust (FI = 28 and FQ = 1.9%) as were pooled rates of TLR (FI = 18 and FQ = 0.9%). However, when safety outcomes were analyzed, the robustness of the meta-analysis decreased significantly. In fact, the relationship between the use of paclitaxel-coated devices and all-cause mortality at mid-term showed very low robustness (FI = 4 and FQ = 0.2%). At 5 years, only the benefit of paclitaxel-based devices to reduce TLR remained robust, with an FI of 32 and an FQ of 3.1%. CONCLUSIONS: The data supporting clinical efficacy endpoints of RCTs that examined paclitaxel-based devices in the treatment of femoral-popliteal arterial occlusive disease were robust; however, the pooled safety endpoints were highly fragile and prone to bias due to loss of patient follow-up in the original studies. These findings should be considered in the ongoing debate concerning the safety of paclitaxel-based devices.
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Angioplastia de Balón , Fármacos Cardiovasculares , Stents Liberadores de Fármacos , Paclitaxel , Enfermedad Arterial Periférica , Ensayos Clínicos Controlados Aleatorios como Asunto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Amputación Quirúrgica , Angioplastia de Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Stents Liberadores de Fármacos/normas , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/normas , Arteria Femoral/fisiopatología , Recuperación del Miembro , Paclitaxel/administración & dosificación , Enfermedad Arterial Periférica/terapia , Arteria Poplítea/fisiopatología , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Dispositivos de Acceso Vascular , Grado de Desobstrucción VascularRESUMEN
OBJECTIVE: The objective of this study was to compare endovascular aortic aneurysm repair (EVAR) versus open aortic repair (OAR) on mortality and reintervention after ruptured infrarenal abdominal aortic aneurysm (rAAA) repair in the Vascular Quality Initiative (VQI). BACKGROUND: The optimal treatment modality for rAAA remains debated, with little data on long-term comparisons. METHODS: VQI rAAA repairs (2004-2018) were matched with Medicare claims (VQI-VISION). Primary outcomes were in-hospital and long-term mortality. Secondary outcome was reintervention. Inverse probability weighting was used to adjust for treatment selection, and Cox Proportional Hazards models and negative binomial regressions were used for analysis. Landmark analysis was performed among patients surviving hospital discharge. RESULTS: Among 1885 VQI/Medicare rAAA patients, 790 underwent OAR, and 1095 underwent EVAR. Median age was 76 years; 73% were male. Inverse probability weighting produced comparable groups. In-hospital mortality was lower after EVAR versus OAR (21% vs 37%, odds ratio: 0.52, 95% CI, 0.4-0.7). One-year mortality rates were lower for EVAR versus OAR [hazard ratio (HR) 0.74, 95% CI, 0.6-0.9], but not statistically different after 1 year (HR: 0.95, 95% CI, 0.8-1.2). This implies additional benefits to EVAR in the short term. Reintervention rates were higher after EVAR than OAR at 2 and 5 years (rate ratio: 1.79 95% CI, 1.2-2.7 and rate ratio:2.03 95% CI, 1.4-3.0), but not within the first year. Reintervention was associated with higher mortality risk for both OAR (HR: 1.66 95% CI, 1.1-2.5) and EVAR (HR: 2.14 95% CI, 1.6-2.9). Long-term mortality was similar between repair types (HR: 0.99, 95% CI, 0.8-1.2). CONCLUSIONS: Within VQI/Medicare patients undergoing rAAA repair, the perioperative mortality rate favors EVAR but equalizes after 1 year. Reinterventions were more common after EVAR and were associated with higher mortality regardless of treatment.
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Aneurisma de la Aorta Abdominal , Rotura de la Aorta , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Masculino , Anciano , Estados Unidos/epidemiología , Femenino , Factores de Riesgo , Aneurisma de la Aorta Abdominal/cirugía , Resultado del Tratamiento , Medicare , Rotura de la Aorta/cirugía , Estudios RetrospectivosRESUMEN
OBJECTIVE: There is paucity of data on the durability of physician modified endografts (PMEGs) for complex abdominal (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs) despite widespread use. The aim of this study was to evaluate and compare the early and long-term outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) for CAAAs and TAAAs using PMEGs. METHODS: We reviewed clinical data and outcomes of patients treated by FB-EVAR using PMEGs for CAAAs (defined as short-neck infrarenal, juxtarenal, and pararenal AAAs) and TAAAs between 2007 and 2019. All patients were treated by a dedicated team with extensive manufactured device experience. Endpoints included 30-day mortality and major adverse events, patient survival and freedom from aortic-related mortality (ARM), freedom from secondary intervention, target artery (TA) patency, and freedom from TA endoleak and TA instability. RESULTS: Of 645 patients undergoing FB-EVAR, 156 patients (24%) treated with PMEG (121 males; mean age, 75 ± 8 years) were included. There were 89 CAAAs, 33 extent IV TAAAs and 34 extent I to III TAAAs. A total of 452 renal-mesenteric targets (3.1 ± 1.0 vessels/patient) were incorporated. Patients with TAAAs had significantly (P < .05) larger aneurysms (73 ± 11 vs 68 ± 14 mm), more TAs incorporated (3.4 ± 0.9 vs 2.8 ± 1.0), and more often had previous aortic repair (54% vs 27%). Technical success was higher in patients treated for CAAAs (99% vs 91%; P = .04). Thirty-day and/or in-hospital mortality was 5.7% and was significantly lower for CAAAs compared with TAAAs (2% vs 10%; P = .04), with three of nine early mortalities (33%) among patients treated emergently. After a mean follow-up of 49 ± 38 months, there were 12 aortic-related deaths (7.6%), including nine early deaths (5.7%) from perioperative complications and three late deaths (1.9%) from rupture. At 5 years, patient survival was 41%. Patients treated for CAAAs had higher 5-year freedom from ARM (P = .016), TA instability (P = .05), TA endoleak (P = .01), and TA secondary interventions (P = .05) with a higher, but non-significant, freedom from sac enlargement ≥5 mm (P = .11). Primary and secondary TA patency was 91% ± 2% and 99% ± 1%, respectively. Sac regression ≥5 mm occurred in 67 patients (43%) and was associated with increased survival (hazard ratio, 0.54; 95% confidence interval, 0.37-0.80) compared with those without sac regression. CONCLUSIONS: FB-EVAR using PMEGs was performed with acceptable long-term outcomes. Overall patient survival was low due to significant underlying comorbidities. Patients treated for CAAAs had higher freedom from ARM, TA instability, TA endoleak, TA secondary interventions, and a trend towards higher freedom from sac enlargement compared with patients treated for TAAAs. Sac regression was associated with improved patient survival.
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Aneurisma de la Aorta Abdominal , Aneurisma de la Aorta Torácica , Aneurisma de la Aorta Toracoabdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Masculino , Humanos , Anciano , Anciano de 80 o más Años , Endofuga , Abdomen , Aorta , Riñón , Procedimientos Endovasculares/efectos adversos , Resultado del Tratamiento , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Implantación de Prótesis Vascular/efectos adversos , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Diseño de Prótesis , Prótesis Vascular , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/terapiaRESUMEN
OBJECTIVE: Statins are considered standard-of-care medical therapy for patients undergoing lower extremity bypass (LEB) procedures for chronic limb-threatening ischemia (CLTI). It is unclear, however, whether up-titrating and maintaining patients on higher-intensity statin medications following LEB improves limb salvage outcomes. This study was designed to evaluate whether high-intensity statin therapy impacts the risk of amputation and reintervention following LEB for patients with CLTI. METHODS: The IBM MarketScan database was used to identify adult patients (18-99 years old) who underwent a LEB for CLTI between 2008 and 2017. Patients lacking insurance covering drug reimbursement or those who already had undergone amputation before time of bypass were excluded. Using pharmacy claims and national drug codes to define statin intensity, patients were stratified into three groups: high-intensity, low-intensity, and limited statin therapy. The association between intensity of statin therapy and need for reintervention and/or major amputation after LEB was analyzed using Kaplan-Meier curves and risk-adjusted Cox proportional hazard models. RESULTS: A total of 25,907 patients who underwent LEB for CLTI were identified, of which 6696 (26%) were maintained on high-dose statins, 9297 (36%) were on low-dose statins, and 9914 (38%) had inconsistent pharmacy claims for statin therapy after surgery. Patients on high-intensity statins were, on average, younger and more likely to be male with comorbid disease (diabetes, hypertension, hyperlipidemia, obesity, renal insufficiency, ischemic heart disease, cerebrovascular disease, and tobacco abuse) than patients on low-intensity statins or limited statin therapy (P < .001 for all comparisons). Following LEB, 6649 patients (25.6%) required a reintervention, and 2550 patients (9.8%) went on to have a major amputation during follow-up. Patients maintained on high-intensity statins after LEB had a significantly lower likelihood of requiring a reintervention (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.45-0.51; P < .001) or amputation (HR, 0.27; 95% CI, 0.24-0.30; P < .001) as compared with patients on limited statin therapy. Further, there was a dose-dependent effect for these outcomes relative to patients on low-intensity statins in risk-adjusted models, and it was independent of whether an autologous vein graft was used for the LEB. Finally, among patients who underwent a reintervention, high-dose statin therapy also significantly reduced the HR for subsequent amputation (HR, 0.21; 95% CI, 0.18-0.25; P < .001). CONCLUSIONS: Patients with CLTI on high-intensity therapy following LEB had a significantly lower risk of requiring subsequent reintervention and amputation when compared with patients on low-intensity statins or with limited statin use. These data suggest that patients with CLTI should be up-titrated and/or maintained on high-intensity statins following revascularization whenever possible.
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Inhibidores de Hidroximetilglutaril-CoA Reductasas , Enfermedad Arterial Periférica , Adulto , Humanos , Masculino , Adolescente , Adulto Joven , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Femenino , Inhibidores de Hidroximetilglutaril-CoA Reductasas/efectos adversos , Isquemia Crónica que Amenaza las Extremidades , Factores de Riesgo , Resultado del Tratamiento , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/cirugía , Isquemia/diagnóstico , Isquemia/cirugía , Recuperación del Miembro , Extremidad Inferior/irrigación sanguínea , Amputación Quirúrgica/efectos adversos , Estudios RetrospectivosRESUMEN
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
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
OBJECTIVE: Staged endovascular repair of complex aortic aneurysms with first-stage thoracic endovascular aortic repair may decrease the risk of spinal cord ischemia (SCI) associated with fenestrated-branched endovascular aortic repair (FB-EVAR) of thoracoabdominal aortic aneurysms or optimize the proximal landing zone in the cases requiring total aortic arch repair. However, a limitation of multistaged procedures is the risk of interval aortic events (IAEs) including mortality from a ruptured aneurysm. We aim to identify the incidence of and risk factors associated with IAEs during staged FB-EVAR. METHODS: This was a single-center, retrospective review of patients who underwent planned staged FB-EVAR from 2013 to 2021. Clinical and procedural details were reviewed. End points were the incidence of and risk factors associated with IAEs (defined as rupture, symptoms, and unexplained death) and outcomes in patients with or without IAEs. RESULTS: Of 591 planned FB-EVAR patients, 142 underwent first-stage repairs. Twenty-two did not have a planned second stage because of frailty, preference, severe comorbidities, or complications after the first stage and were excluded. The remaining 120 patients (mean age: 73 ± 6 years, 51% female) were planned for second-stage completion FB-EVAR and comprised our cohort. The incidence of IAEs was 13% (16 of 120). This included confirmed rupture in 6 patients, possible rupture in 4, symptomatic presentation in 4, and early unexplained interval death with possible rupture in 2. The median time to IAEs was 17 days (range: 2-101 days), and the median time to uncomplicated completion repairs was 82 days (interquartile range: 30-147 days). Age, sex, and comorbidities were similar between the groups. There were no differences in familial aortic disease, genetically triggered aneurysms, aneurysm extent, or presence of chronic dissection. Patients with IAEs had significantly larger aneurysm diameters than those without IAEs (76.6 vs 66.5 mm, P ≤ .001). This difference persisted with indexing for body surface area (aortic size index: 3.9 vs 3.5 cm/m2, P = .04) and height (aortic height index: 4.5 vs 3.9 cm/m, P ≤ .001). IAE mortality was 69% (11 of 16) compared with no perioperative deaths for those with uncomplicated completion repairs. CONCLUSIONS: The incidence of IAEs was 13% in patients planned for staged FB-EVAR. This represented a notable morbidity, including rupture, which must be balanced with SCI and landing zone optimization when planning repair. Larger aneurysms, especially when adjusted for body surface area, are associated with IAEs. Minimizing time between stages vs single-stage repairs for larger (>7 cm) complex aortic aneurysms in patients with reasonable SCI risk should be considered when planning repair.
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Aneurisma de la Aorta Abdominal , Aneurisma de la Aorta Torácica , Aneurisma de la Aorta , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Isquemia de la Médula Espinal , Humanos , Femenino , Anciano , Masculino , Prótesis Vascular , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/efectos adversos , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/epidemiología , Aneurisma de la Aorta Torácica/cirugía , Reparación Endovascular de Aneurismas , Incidencia , Resultado del Tratamiento , Procedimientos Endovasculares/efectos adversos , Factores de Riesgo , Aneurisma de la Aorta/cirugía , Isquemia de la Médula Espinal/diagnóstico , Isquemia de la Médula Espinal/epidemiología , Isquemia de la Médula Espinal/etiología , Estudios RetrospectivosRESUMEN
BACKGROUND: The longitudinal clinical significance of type II endoleaks (T2ELs) remains controversial. Specifically, the real-world incidence, need for reintervention, and associated mortality referable to T2ELs remain unknown. Moreover, current professional society clinical practice guidelines recommend differing aneurysm sac growth thresholds to prompt intervention. Therefore, the purpose of this analysis was to better quantify the prevalence of early T2ELs after infrarenal endovascular aortic aneurysm repair (EVAR) and determine its association with reintervention and survival. METHODS: All elective EVARs from the Vascular Quality Initiative (2010-2020) were examined to identify patients with isolated T2ELs vs no endoleak (NONE) at discharge. Procedures with a type I or III endoleak were excluded. A subgroup analysis was performed on patients surviving beyond the first postoperative year with follow-up data available on endoleaks. The primary outcome was overall survival. Secondary outcomes included perioperative mortality and reinterventions. Outcomes were assessed by multivariable logistic and Cox proportional hazards regression to adjust for covariates. RESULTS: We identified 53,697 patients who underwent EVAR. The overall incidence of isolated T2ELs at discharge was 16%. In-hospital mortality was lower for those with isolated T2ELs vs NONE (0.8% vs 1.9%, odds ratio: 0.6, 95% confidence interval: 0.5-0.8, P < .0001). Unadjusted overall survival was marginally higher at 5 years for patients with T2ELs vs NONE (84% vs 82%); however, after risk adjustment, survival was similar (hazard ratio: 0.95, 95% confidence interval: 0.9-1.0). Among 44,345 patients with 1-year follow-up, 66% had data on endoleak status for assessment. Survival was similar regardless of endoleak status (NONE, at discharge only, at follow-up only, or at both time points). Among patients with documented T2ELs during follow-up, 6.1% and 2.5% had abdominal aortic aneurysm sac diameter growth ≥5 mm and ≥10 mm, respectively. Reinterventions occurred in 12%. Rupture (1%) and any open reintervention (4%) were rare among patients with 1-year follow-up. For patients with T2ELs, 5-year survival was similar between those with and without reintervention by 1 year (89% vs 91%, log-rank P = .06). CONCLUSIONS: T2ELs remain common after EVAR within the Vascular Quality Initiative and are not associated with long-term mortality. Reinterventions for T2ELs were not associated with improved overall survival among patients with T2ELs. Although additional data surrounding the appropriate role of reintervention for T2ELs remain necessary, it appears that the natural history of T2ELs is benign.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/complicaciones , Reparación Endovascular de Aneurismas , Incidencia , Alta del Paciente , Resultado del Tratamiento , Factores de Riesgo , Endofuga/diagnóstico por imagen , Endofuga/epidemiología , Endofuga/etiología , Hospitales , Estudios RetrospectivosRESUMEN
OBJECTIVE: Fenestrated/branched endovascular aortic repair (F/BEVAR) in patients with occluded iliac arteries is challenging owing to limited access for branch vessel catheterization and increased risk for leg and spinal ischemic complications. The aim of this study was to analyze technical strategies and outcomes of F/BEVAR in patients with unilateral iliofemoral occlusive disease. METHODS: We performed a retrospective review of all consecutive patients treated by F/BEVAR in two institutions (2003-2021). Patients with unilateral iliofemoral occlusive disease were included in the analysis. All patients had one patent iliac artery that was used for advancement of the fenestrated-branch component. Preloaded catheter/guidewire systems or steerable sheaths were used as adjuncts to facilitate catheterization. Primary endpoints were technical success, mortality, major adverse events (stroke, spinal cord injury, dialysis or decrease in the glomerular filtration rate of more than 50%, bowel ischemia, myocardial infarction, or respiratory failure), primary iliac patency, and freedom from reinterventions. RESULTS: There were 959 patients treated with F/BEVAR. Of these, 15 patients (1.56%; mean age, 74 years; 80% male) had occluded iliac arteries and 1 patent iliofemoral access and were treated for a thoracoabdominal aortic aneurysm (n = 8) or juxtarenal abdominal aortic aneurysm (n = 7). Brachial access was used in 14 of the 15 patients and preloaded systems in 7 of the 15 patients (47%). The remaining 53% had staggered deployment of stent grafts. There were seven physician-modified endovascular grafts, seven custom-made devices, and one off-the-shelf device used. Thirteen patients (87%) had distal seal using aortouni-iliac stent grafts and two (13%) had distal seal in the infrarenal aorta. Concomitant femoral crossover bypass (FCB) was performed in two patients and six patients had a prior FCB. Technical success was 100%. There were no intraoperative complications or early lower extremity ischemic complications, and all FCB were preserved. There was one mortality (7%) within 30 days owing to retrograde type A dissection. Major adverse events occurred in 20% of patients. The median follow-up was 12 months (range, 0-85 months). Two patients (13%) required three reinterventions. One patient required proximal stent graft extension for an acute type B dissection (3 months) and another required iliac extension for type Ib endoleak of an aortouni-iliac graft (21 months) and thrombolysis of that extension (50 months). At last follow-up, all patients had primary graft patency except one with secondary graft patency without new claudication. One patient had a single renal artery stent occlusion at follow-up with no r-intervention. The overall survival rate was 60%, without aortic-related deaths. CONCLUSIONS: Although challenging, F/BEVAR with unilateral femoral/brachial approach is feasible in patients with occluded iliac limbs, with an important rate of ischemic complications, but satisfactory outcomes.