RESUMEN
BACKGROUND: Prior studies suggest female sex is associated with worse outcomes after complex endovascular aortic aneurysm repair (EVAR) due to anatomic differences. Therefore, we aimed to compare 30-day perioperative and long-term outcomes after complex EVAR by sex. METHODS: A single-center retrospective review of consecutive elective and emergent complex EVAR with company-manufactured devices, laser fenestration, snorkel/periscope, or octopus technique was performed from 2012-2023. The primary outcome was a composite endpoint of any major adverse event (MAE), new-onset dialysis, or death within 30 days. Secondary 30-day technical and long-term outcomes were also assessed. RESULTS: 293 patients (57 females, 19%), mean age 74 years, underwent complex EVAR with commercially available Zenith fenestrated endovascular graft (71%), p-Branch (2%), laser fenestration (8%), snorkel/periscope (16%), or octopus (2%) techniques. Females had significantly different aneurysm-related anatomic characteristics compared to males, including smaller aneurysm diameters (58 ± 7.2 vs. 64 ± 13.2 mm, P < 0.001), more involved aneurysm extent (21.7% vs. 9.8% thoracoabdominal, P = 0.04), increased renal artery calcification (43.9% vs. 27.1%, P = 0.01), and smaller iliac (7.6 ± 1.3 vs. 8.9 ± 1.8 mm, P < 0.01). Operative outcomes were similar; however, females had a greater need for adjunctive access conduits (21.1% vs. 10.6%, P = 0.04), lower technical success (91.2% vs. 98.3%, P = 0.02), and longer median [interquartile range] length of stay (3.0 [4.0] vs. 2.0 [2.5] days, P < 0.001). The composite 30-day outcome of any MAE, new dialysis, or death was not significantly different (15.8% females vs. 11.4% males, P = 0.37). Technical endpoints including 30-day rates of target artery occlusion and type 1 or 3 endoleak were also similar between groups. At mean follow-up of nearly 3 years, females had significantly lower rate of renal function decline (16.0% vs. 41.9%, P < 0.001), but no differences were found in long-term all-cause mortality, aneurysm sac regression, reintervention, or total follow-up imaging studies between groups. CONCLUSIONS: Females undergoing complex EVAR had challenging anatomy with higher intraoperative target artery occlusion, conduit use, and longer length of stay. However, 30-day and long-term outcomes were similar, suggesting females can undergo complex EVAR with high technical success and comparable perioperative outcomes to males. Females appeared to have protection from long-term renal function decline, which will be important for future study.
RESUMEN
BACKGROUND: Fenestrated endovascular aneurysm repair (FEVAR) is a well-established treatment approach for juxtarenal and short-neck infrarenal aortic aneurysms. Recommendations and clinical outcomes are lacking for offering FEVAR in patients with chronic kidney disease (CKD). We aimed to compare short- and long-term outcomes for patients with none-to-mild versus moderate-to-severe CKD undergoing FEVAR. METHODS: We retrospectively reviewed consecutive patients undergoing standard FEVAR with Cook devices at a single institution. The cohort was stratified by preoperative CKD stage none-to-mild or moderate-to-severe (CKD 1-2 and CKD 3-5, respectively). The primary outcome was postoperative acute kidney injury (AKI). Secondary outcomes included 30-day perioperative complications, 1- and 5-year rates of overall survival, dialysis, renal target artery patency, endoleak, and reintervention assessed by the Kaplan-Meier method. Aneurysm sac regression, number of surveillance computed tomography (CT) scans, and CKD stage progression were assessed at latest follow-up. Multivariate Cox proportional hazards modeling was used to evaluate the association of CKD stage 3 and stage 4-5 with all-cause mortality, controlling for differences in baseline characteristics. RESULTS: From 2012- to 2022, 184 patients (of which 82% were male) underwent FEVAR with the Cook ZFEN device (mean follow-up 34.3 months). Group CKD 3-5 comprised 77 patients (42%), was older (75.2 vs. 73.0 years, P = 0.04), had increased preoperative creatinine (1.6 vs. 0.9 mg/dL, P < 0.01), and demonstrated increased renal artery ostial calcification (37.7% vs. 21.5%, P = 0.02) compared with Group CKD 1-2. Perioperatively, CKD 3-5 sustained higher estimated blood loss (342 vs. 228 ml, P = 0.01), longer operative times (186 vs. 162 min, P = 0.04), and longer length of stay (3 vs. 2 days, P < 0.01). Kaplan-Meier 1- and 5-year survival estimates were lower for CKD 3-5 (82.3% vs. 95.1%, P < 0.01 and 55.4% vs. 70.8%, P = 0.02). Fewer CKD 3-5 patients remained free from chronic dialysis at 1 year (94.4% vs. 100%, P = 0.015) and 5 years (84.7% vs. 100%, P < 0.01). There were no significant differences in postoperative AKI rate (CKD 1-2 6.5% vs. CKD 3-5 14.3%, P = 0.13), long-term renal artery patency, reinterventions, type I or III endoleak, mean sac regression, or total follow-up CT scans between groups. CKD stage progression occurred in 47 patients (31%) at latest follow-up but did not differ between stratified groups (P = 0.17). On multivariable modeling, age (hazard ratio 1.05, 95% confidence interval 1.01-1.09, P = 0.02) and CKD stage 4-5 (hazard ratio 6.39, 95% confidence interval 2.26-18.05, P < 0.01) were independently associated with mortality. CONCLUSIONS: Preoperative CKD status did not negatively impact the durability or technical success related to aneurysm outcomes after FEVAR. Worsening CKD stage was associated with lower 1- and 5-year overall survival and freedom from dialysis after FEVAR with no statistically significant differences in 30-day or long-term technical aneurysm outcomes.
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Lesión Renal Aguda , Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Insuficiencia Renal Crónica , Humanos , Masculino , Femenino , Prótesis Vascular/efectos adversos , Aneurisma de la Aorta Abdominal/complicaciones , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Reparación Endovascular de Aneurismas , Stents/efectos adversos , Endofuga/cirugía , Estudios Retrospectivos , Resultado del Tratamiento , Factores de Riesgo , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/diagnóstico , Lesión Renal Aguda/diagnóstico , Lesión Renal Aguda/etiología , Diseño de PrótesisRESUMEN
OBJECTIVE: Fenestrated endovascular aneurysm repair (FEVAR) is increasingly used in the treatment of juxtarenal aortic aneurysms and short-neck infrarenal aneurysms. Reinterventions (REIs) occur frequently, contributing to patient morbidity and resource utilization. We sought to determine whether REI affects long-term survival after FEVAR. METHODS: A single-institution retrospective review of all Cook Zenith fenestrated (ZFEN; Cook Medical, Inc, Bloomington, IN) repairs was performed. Patients with ≥6 months of follow-up and without adjunctive branch modifications were included. REI was defined as any aneurysm, device, target branch, or access-related intervention after the index procedure. REIs were categorized as early (<30 days) or late (≥30 days), by indication (ie, branch, endoleak, limb related, access related, other), and by target branch or device components. Patients were stratified into REI vs no REI groups and branch REI vs non-branch REI groups. RESULTS: Of 219 consecutive ZFEN repairs from 2012 to 2021, 158 patients met the inclusion criteria. Of these 158 patients, 41 (26%) required a total of 51 REIs (10 early and 41 late) during a mean follow-up of 33.9 months. The most common indication for REI was branch-related (31 of 51; 61%), with the renal arteries the most frequently affected (26 of 51; 51%). The only differences found in baseline, aneurysm, and device characteristics were a higher mean Society for Vascular Surgery comorbidity score (9.6 vs 7.9; P = .04) and larger suprarenal neck angle (23.3° vs 17.1°; P = .04) in the no REI group. In contrast, the REI group had a larger mean proximal seal zone diameter (26.3 mm vs 25.1 mm; P = .03) and device diameter (31.9 mm vs 30.0 mm; P = .002) compared with the no REI group. Technical success and operative characteristics were similar between the groups, except for a longer mean fluoroscopy time (74.9 minutes vs 60.8 minutes; P = .01) and longer median length of stay (2 vs 2 days; P = .006) for the REI group. Although the rate of early (<30 days) major adverse events was greater for the REI group (24.4% vs 6.0%; P = .001), the difference in 30-day mortality was not statistically significant (4.9% vs 0.9%; P = .10). On Kaplan-Meier analysis, freedom from REI at 1 and 5 years was 85.7% and 62.6%, respectively, for the overall cohort. No difference was found in the estimated 5-year survival between the REI and no REI groups (62.8% vs 63.5%; log-rank, P = .87) and branch REI and non-branch REI groups (71.8% vs 49.9%; log-rank, P = .16). On multivariate analysis, REI was not an independent predictor for mortality. However, age, Society for Vascular Surgery comorbidity score, and preoperative maximum aneurysm diameter each increased the hazard of death (hazard ratio [HR], 1.07; 95% confidence interval [CI], 1.02-1.12 [P = .007]; HR, 1.10; 95% CI, 1.01-1.18 [P = .02]; HR, 1.05; 95% CI, 1.02-1.08 [P = .003], respectively). CONCLUSIONS: After ZFEN, 41 patients (26%) had required a total of 51 REIs, with most occurring ≥30 days after the index procedure, and 61% were branch related, with no influence on 5-year survival. Age, comorbidity, and baseline aneurysm diameter independently predicted mortality. The use of FEVAR mandates lifelong surveillance and protocols to maintain branch patency. Despite their relative frequency, REIs did not influence 5-year postprocedural survival.
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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/etiología , Prótesis Vascular , Diseño de Prótesis , Resultado del Tratamiento , Factores de Riesgo , Factores de Tiempo , Estudios RetrospectivosRESUMEN
BACKGROUND: Fenestrated endovascular aneurysm repair is an established customized treatment for aortic aneurysms with 3 current commercially available configurations for the superior mesenteric artery (SMA)-a single-wide scallop, large fenestration, or small fenestration, with the scallop or large fenestration most utilized. Outcomes comparing SMA single-wide scallops to large fenestrations with the Zenith fenestrated (ZFEN) device are scarce. As large fenestrations have the benefit of extending the proximal seal zone compared to scalloped configurations, we sought to determine the differences in seal zone and sac regression outcomes between the 2 SMA configurations. METHODS: We retrospectively reviewed our prospectively maintained complex endovascular aneurysm repair database and included all patients treated with the Cook ZFEN device with an SMA scallop or large fenestration configuration at its most proximal build. All first postoperative computed tomography scans (1-30 days) were analyzed on TeraRecon to determine precise proximal seal zone lengths, and standard follow-up anatomic and clinical metrics were tabulated. RESULTS: A total of 234 consecutive ZFEN patients from 2012 to 2021 were reviewed, and 137 had either a scallop or a large fenestration for the SMA as the proximal-most configuration (72 scallops and 65 large fenestrations) with imaging available for analysis. The mean follow-up was 35 months. The mean proximal seal zone length was 19.5 ± 7.9 mm for scallop versus 41.7 ± 14.4 mm for large fenestration groups (P < 0.001). There was no difference in sac regression between the scallop and large fenestration at 1 year (10.1 ± 10.9 mm vs. 11.0 ± 12.1, P = 0.63). Overall, 30-day mortality (1.3% vs. 2.5%, P = 0.51) and all-cause 3-year mortality (72.5% vs. 81.7%, P = 0.77) were not significantly different. Reinterventions within 30 days were primarily secondary to renal artery branch occlusions, with only 1 patient in the scallop group requiring reintervention for an SMA branch occlusion. CONCLUSIONS: Despite attaining longer proximal seal lengths, large SMA fenestrations were not associated with a difference in sac regression compared to scalloped SMA configurations at a one-year follow-up. There were no significant differences in reinterventions or overall long-term survival between the 2 SMA strategies.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Pectinidae , Humanos , Animales , Arteria Mesentérica Superior/diagnóstico por imagen , Arteria Mesentérica Superior/cirugía , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/etiología , Prótesis Vascular , Estudios Retrospectivos , Diseño de Prótesis , Resultado del TratamientoRESUMEN
Objective: Proximal endovascular reintervention after prior endovascular aortic repair (EVAR) or open abdominal aortic aneurysm repair (OR) can be challenging due to the short distance to the visceral branches. We present a novel solution to allow the use of the commercially available ZFEN device using a double-barrel, kissing-limb technique. Methods: Patients who underwent fenestrated repair for proximal failure after EVAR or OR were identified. The ZFEN device is deployed above the prior graft flow divider. Once the visceral branches are secured, kissing limbs are used to connect with the prior graft limbs. The distal diameter of the standard ZFEN is 24 mm, accommodating two 20 mm components according to the formula 2πDLIMB = πDZFEN + 2DZFEN. Results: Of 235 patients who underwent repair using ZFEN from 2012 to 2021 at a single institution, 28 were treated for proximal failure of prior repairs, with 13 treated using the double-barrel technique (8 EVAR, 5 OR). The distance from the flow divider to the lowest renal artery was 67 ± 24.4 mm (range, 39-128 mm), and the distance to the superior mesenteric artery (SMA) was 87 ± 30.5 mm (range, 60-164 mm). Technical success was 100%. Seven patients had standard ZFEN builds (2 renal small fenestrations, SMA large fen/scallop). The minimum distance to the lowest renal artery and SMA to accommodate a standard ZFEN build was 56 and 60 mm, respectively. Four patients required adjunctive snorkel grafts and two required laser fenestrations. Two patients had gutter leaks at 1 month that self-resolved; one patient developed a late type 1a endoleak. Freedom from reintervention was 90%, 72%, and 48% at 1, 2, and 3 years, respectively. Conclusions: This double-barrel technique allows for distal seal of commercial ZFEN devices into prior open or endovascular repairs with good technical success. Long-term outcomes remain to be quantified.