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BACKGROUND: Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal aortic aneurysm, however, previous data are limited to small single center studies and robust data on safety and effectiveness of PMEGs are lacking. We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. METHODS: An international multicenter single-arm cohort study was performed analyzing the outcomes of PMEGs in the treatment of elective, symptomatic, and ruptured complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. Variables and outcomes were defined according to the Society for Vascular Surgery reporting standards. Device modification and procedure details were collected and analyzed. Efficacy outcomes included technical success and safety outcomes included major adverse events and 30-day mortality. Follow-up outcomes included reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. Multivariable analysis was performed aiming at identifying predictors of technical success, 30-day mortality, and major adverse events. RESULTS: Overall, 1274 patients were included in the study from 19 centers. Median age was 74 (IQR, 68-79), and 75.7% were men; 45.7% were complex abdominal aortic aneurysms, and 54.3% were thoracoabdominal aortic aneurysms; 65.5% patients presented electively, 24.6% were symptomatic, and 9.9% were ruptured. Most patients (83.1%) were submitted to a fenestrated repair, 3.6% to branched repair, and 13.4% to a combined fenestrated and branched repair. Most patients (85.8%) had ≥3 target vessels included. The overall technical success was 94% (94% in elective, 93.4% in symptomatic, and 95.1% in ruptured cases). Thirty-day mortality was 5.8% (4.1% in elective, 7.6% in symptomatic, and 12.7% in ruptured aneurysms). Major adverse events occurred in 25.2% of cases (23.1% in elective, 27.8% in symptomatic, and 30.3% in ruptured aneurysms). Median follow-up was 21 months (5.6-50.6). Freedom from reintervention was 73.8%, 61.8%, and 51.4% at 1, 3, and 5 years; primary target vessel patency was 96.9%, 93.6%, and 90.3%. Overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6%, and 55.0%/89.1% at 1, 3, and 5 years. CONCLUSIONS: PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data and future prospective studies are needed for more robust and detailed analysis.
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OBJECTIVE: Superficial femoral artery (SFA) stenting is a common treatment for peripheral artery disease. It is effective in the short term; however, in-stent restenosis (ISR) limits long-term success. Surveillance with duplex ultrasound (DUS) can identify patients who develop ISR leading to early reintervention, but data to support this practice is sparce. The purpose of this study was to evaluate whether surveillance and subsequent reintervention improves outcomes in patients with SFA stents. METHODS: A single-center, retrospective study was performed with patients undergoing SFA stenting between 2005 and 2020 who had a follow-up with DUS. Five groups were identified based on the presence of ISR on DUS (ISR vs no ISR [NISR]), recurrence of symptoms (symptomatic [SX] vs asymptomatic [ASX]), and if any reintervention was performed (reintervention [R] vs no reintervention [NR]): (1) ISR+SX+R; (2) ISR+SX+NR; (3) ISR+ASX+R; (4) ISR+ASX+NR; and (5) NISR+NR. The primary endpoint was amputation-free survival, and the secondary endpoint was patency. Predictors of mortality and surveillance were identified by multivariable logistic regressions and Cox multivariate regression models. Survival curves were presented as Kaplan-Meier plots using log-rank test for subgroup comparison. RESULTS: Two hundred fifty-seven patients were included in the analysis. The indication for intervention was claudication in 28% and chronic limb-threatening ischemia in 72%. A total of 161 patients (63%) underwent reintervention for ISR. Of patients who had restenosis on DUS, those who were symptomatic and did not undergo reintervention (ISR+SX+NR) did the worst, with 50% amputation rate. In contrast, those who were asymptomatic but did undergo reintervention (ISR+ASX+R) had the lowest amputation rate of 13%. Active smoking was a predictor of both loss of patency and amputation (1.72; 95% confidence interval [CI], 1.00-2.98; P = .050; 3.55; 95% CI, 1.53-8.25; P = .003). Post procedure dual antiplatelet therapy had a positive association with limb salvage (hazard ratio [HR], 0.23; 95% CI, 0.09-0.58; P = .001), whereas diabetes (HR, 2.61; 95% CI, 1.21-6.01; P = .019), stent occlusion (HR, 17.0; 95% CI, 5.93-63.1; P < .001), and chronic limb-threatening ischemia presentations (HR, 4.31; 95% CI, 1.86-11.7; P=.002) were negatively associated with limb salvage. CONCLUSIONS: Routine surveillance DUS and subsequent reintervention on ISR after SFA stenting is associated with improved patency and amputation-free survival. Surveillance DUS should be routine for patients after stenting, with reintervention strongly considered if ISR is identified for both symptomatic and asymptomatic.
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Arteria Femoral , Enfermedad Arterial Periférica , Humanos , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/cirugía , Isquemia Crónica que Amenaza las Extremidades , Estudios Retrospectivos , Resultado del Tratamiento , Factores de Riesgo , Grado de Desobstrucción Vascular , Stents , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Constricción PatológicaRESUMEN
OBJECTIVE: Fibromuscular dysplasia (FMD) is a noninflammatory arterial disease that affects the extracranial carotid arteries in young patients. The ideal treatment of FMD has continued to be debated, and the role of carotid artery stenting (CAS) is controversial. The aim of the present study was to assess the feasibility and outcomes of CAS for patients with FMD. METHODS: A retrospective analysis of patients who had undergone CAS was performed using the Vascular Quality Initiative database from December 2012 to May 2021. Patients who had undergone CAS for atherosclerosis and FMD were included and matched 1:1 by age, gender, and clinical presentation. The demographics, clinical parameters, and procedural data were analyzed. The end points included postoperative stroke and transient ischemic attack (TIA), and adverse events (perioperative and 1-year mortality, neurologic changes, access site complications, hematoma or bleeding, infection, congestive heart failure, arrhythmia, myocardial infarction, reperfusion symptoms), and hospital length of stay. RESULTS: After matching, 55 patients had undergone CAS for FMD (mean age, 58.7 ± 14 years; 62% women; 69% White; mean body mass index, 28 ± 6 kg/m2). Most of these procedures (69%) were elective. The FMD group had had a lower rate of hypertension (55% vs 82%; P = .002), smoking (35% vs 80%; P < .001), diabetes (13% vs 45%; P < .001), and coronary artery disease (9% vs 45%; P < .001) compared with the non-FMD group. In the FMD group, prior TIA and stroke was identified in 39 (71%) and 31 (57%) patients, respectively. The mean interval from a prior stroke or TIA to the index surgery was 160 days. Additionally, 23 patients (42%) had had anatomically high lesions above the level of the second cervical vertebra. In the FMD group, the transfemoral approach was used for 43 patients (78%), with distal embolic protection used for 40 patients (93%). Flow reversal was used for nine patients (23%). Most cases were performed with local anesthesia (58%). Three patients (6%) in the FMD group had had access site complications that were managed nonoperatively. No differences were found between the FMD and non-FMD groups in perioperative stroke, TIA, or 30-day mortality. The length of stay was similar between the two groups, and the 1-year survival was 100% for both groups. All the patients in the FMD group were discharged without neurologic complications, and 50 patients (91%) were receiving dual antiplatelet therapy. The median follow-up was 328 days (interquartile range, 1-732 days) with no mortality or reinterventions during follow-up. CONCLUSIONS: CAS for FMD is a feasible and safe procedure with favorable technical success, a low incidence of neurologic complications, and good clinical outcomes at 1 year of follow-up.
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Estenosis Carotídea , Displasia Fibromuscular , Ataque Isquémico Transitorio , Accidente Cerebrovascular , Humanos , Femenino , Adulto , Persona de Mediana Edad , Anciano , Masculino , Ataque Isquémico Transitorio/etiología , Estenosis Carotídea/cirugía , Estudios Retrospectivos , Displasia Fibromuscular/complicaciones , Resultado del Tratamiento , Stents/efectos adversos , Accidente Cerebrovascular/etiología , Factores de Riesgo , Medición de RiesgoRESUMEN
OBJECTIVE: Chronic kidney disease (CKD) and end-stage renal disease are traditionally associated with worse outcomes after endovascular and open repair of abdominal aortic aneurysm (AAA). This study stratifies outcomes of AAA repair by approach, CKD severity, and dialysis dependence. METHODS: All patients undergoing elective infrarenal open aneurysm repair (OAR) and endovascular aortic repair (EVAR) with preoperative renal function data captured by the Vascular Quality Initiative between January 2003 and September 2020 were analyzed. Patients were stratified by CKD class as follows: CKD stages 1 and 2, CKD stage 3a, CKD stage 3b, CKD stages 4 and 5, and dialysis. Primary outcomes were perioperative and 1-year mortality. Predictors of survival were identified by Cox multivariate regression models. RESULTS: In total, 53,867 elective AAA repairs were identified: 5396 (10%) OARs and 48,471 (90%) EVARs. Most patients were White (90%) and male (81%), with a mean age of 73 ± 9 years. Patients who underwent EVAR were older and had more comorbidities. The use of elective EVAR for AAA increased from 52% in 2003 to 91% in 2020 (P < .001). The OAR cohort had more perioperative complications and short-term mortality. The CKD 1 and 2 group had the highest 1-year survival compared with the other groups after both OAR and EVAR. On Cox regression analysis, after EVAR, compared with CKD 1 and 2, worsening CKD stage (CKD 3a: hazard ratio [HR], 1.25; 95% confidence interval [CI], 0.93-1.68; P = .13; CKD 3b: HR, 1.74; 95% CI, 1.23-2.45; P < .050; CKD 4-5: HR, 3.23; 95% CI, 2.13-4.88; P < .001), and dialysis (HR, 4.48; 95% CI, 1.90-10.6; P < .001) were independently associated with worse 1-year survival rates. After OAR, compared with CKD 1 and 2, worsening CKD stage (CKD 3a: HR, 1.08; 95% CI, 0.96-1.20; P = .20; CKD 3b: HR, 1.60; 95% CI, 1.41-1.81; P < .001; CKD 4-5: HR, 2.85; 95% CI, 2.39-3.41; P < .001), and dialysis (HR, 3.79; 95% CI, 3.01-4.76; P < .001) were independently associated with worse 1-year survival rates. CONCLUSIONS: Regardless of the treatment approach, CKD severity is an important predictor of perioperative and 1-year mortality rates after infrarenal AAA repair and may reflect the natural history of CKD. Open repair is associated with high perioperative mortality risk in patients with CKD stages 4 and 5, as well as end-stage renal disease. Individualization of patient decision-making is especially important in patients with a glomerular filtration rate of less than 45 and perhaps consideration should be given to raising the threshold for elective AAA repair in these patients. Further studies focusing on appropriate size threshold for repair in these patients may be warranted.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Fallo Renal Crónico , Insuficiencia Renal Crónica , Humanos , Masculino , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Procedimientos Endovasculares/efectos adversos , Factores de Riesgo , Resultado del Tratamiento , Estudios Retrospectivos , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/terapia , Fallo Renal Crónico/terapia , Aneurisma de la Aorta Abdominal/complicaciones , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/efectos adversosRESUMEN
OBJECTIVE: Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters. METHODS: A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter. RESULTS: Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively. CONCLUSIONS: The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results.
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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 , Humanos , Masculino , Anciano , Femenino , Prótesis Vascular , Reparación Endovascular de Aneurismas , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Estudios Retrospectivos , Estudios de Cohortes , Resultado del Tratamiento , Factores de Tiempo , Diseño de PrótesisRESUMEN
OBJECTIVE: Total endovascular repair of aortic arch aneurysms is feasible in select patients. This study aims to evaluate the feasibility and early outcomes of total endovascular arch repair using 3-vessel company-manufactured devices (CMDs) and physician-modified endo grafts (PMEGs). METHODS: Patients unfit for open repair who underwent 3-vessel total arch repair at a single institution from 2018 to 2021 were reviewed. Patients received either 3-vessel inner-branch CMDs or PMEGs. Three-vessel designs were used to incorporate the innominate, left common carotid, and left subclavian arteries. The antegrade inner branches in both devices were accessed via right brachial or carotid approach. The left carotid was accessed via carotid cutdown or femoral approach. The left subclavian artery was accessed via transfemoral approach. The study endpoints included procedural technical success, patient survival, neurologic events, cardiac complications, reinterventions, and target artery patency. RESULTS: Nine patients underwent treatment. Four patients were treated with PMEGs, and 5 with CMDs. Procedural technical success was 100%. There were no in-hospital deaths. There were no strokes, transient ischemic attacks, myocardial infarction, or spinal ischemia in the perioperative period. Major adverse events occurred in 3 patients (33%). Two (22%) vascular access complications and one (11%) acute kidney injury occurred. One (11%) patient required early reintervention for an access complication. The median follow-up period was 358 days (CMD, 392 days; PMEG, 198 days). There was a late reintervention and conversion to open repair at 142 days of follow-up in a patient with a PMEG that developed an aortic infection, leading to death on postoperative day 239. The mean length of stay was 7±4 days. Computed tomography imaging obtained during the immediate postoperative period revealed endoleak in 6 (66%) patients, out of which 5 resolved spontaneously and 1 required reintervention via left subclavian artery stenting. Target artery patency was 100% at the end of the follow-up period. CONCLUSIONS: Three-vessel total endovascular aortic arch repair using a CMD or PMEG is feasible with optimal early outcomes. Physician-modified stent-grafts are a feasible option for patients who do not meet anatomic criteria for CMDs. CLINICAL IMPACT: Management of aortic arch disease remains a significant challenge in vascular surgery. This study showcases the feasibility and safety of using a total endovascular approach to repair the aortic arch, which could potentially reduce morbidity and mortality associated with traditional surgical approaches. The results suggest that this minimally invasive technique could be an alternative treatment option for high-risk patients and could significantly improve outcomes for those requiring aortic arch repair. Overall, this study represents a promising development in the field of endovascular surgery and highlights the potential to improve patient outcomes.
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BACKGROUND: Endovascular repair of thoracic aortic aneurysms (TAA) in elective settings has demonstrated successful clinical outcomes. However, life-threatening conditions such as rupture are more often managed with open surgical repair due to the high complexity of arch endovascular repair, lack of available off-the-shelf devices, and limited long-term data. CASE SUMMARY: A 49-year-old female with a recent history of prior ascending aortic repair for Type A10 aortic dissection presented with chest pain and dyspnea. Chest computed tomography angiogram (CTA) revealed acute bilateral pulmonary emboli and a 6.2 cm post dissection aneurysm of the posterior aortic arch with the dissection extending to the right iliac artery. She was treated with thrombolysis and subsequently became hemodynamically unstable. Repeat CTA revealed a massive left hemithorax with concern for aortic arch rupture. Given significant cardiorespiratory compromise and recent open repair, she was considered unfit for redo open repair. Thoracic endovascular aortic repair (TEVAR) with a physician-modified endograft (PMEG) was planned. An Alpha Zenith endograft was modified adding an internal branch for the innominate artery and a fenestration for the left common carotid artery. The left subclavian artery was occluded with a microvascular plug and coil embolization up to the level of the vertebral artery. TEVAR PMEG extension to the celiac artery was performed followed by deployment of a Zenith dissection stent to the aortic bifurcation. Completion angiogram demonstrated successful aneurysm exclusion and patency of target vessels. CONCLUSION: Endovascular treatment of ruptured TAA with PMEGs is feasible. This approach may be an alternative for unfit patients for open repair in emergent settings.
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We report our initial experience using Fiber Optic RealShape (FORS), an innovative real-time three-dimensional visualization technology that uses light instead of radiation, to achieve upper extremity (UE) access during fenestrated/branched endovascular aortic aneurysm repair (FBEVAR). An 89-year-old male patient with a type III thoracoabdominal aortic aneurysm, unfit for open aortic repair, underwent FBEVAR. Dual fluoroscopy, intravascular ultrasound, and three-dimensional fusion overlay were used, in addition to FORS. All target artery catheterizations were successfully accomplished using FORS, from UE access, without radiation. Our experience demonstrates that FBEVAR with FORS using UE access can be used for target artery catheterization without radiation.
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Superior mesenteric artery aneurysms are rare and associated with high mortality rates in cases of rupture. Current Society for Vascular Surgery guidelines recommend treatment of all superior mesenteric artery aneurysms regardless of size. A 53-year-old woman who was admitted for abdominal pain was found with a 14-cm, ruptured superior mesenteric artery branch aneurysm. Endovascular approach was performed with microvascular plug embolization of a feeding branch and aneurysm sac exclusion with a stent graft. Four months later, the patient demonstrated a 21% regression of the aneurysm and stent patency. Thus, timely diagnosis and treatment of superior mesenteric artery aneurysms with endovascular techniques can reduce potential complications.
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The advent of steerable sheaths has contributed to a decrease in the use of preloaded delivery systems and upper extremity access for fenestrated and branched repairs. However, the use of brachial access and preloaded delivery systems is often still necessary and useful in the treatment of complex thoracoabdominal, pararenal, and aortic arch aneurysms. This review describes the outcomes of brachial access and preloaded delivery systems and provides a thorough description of the types of preloaded delivery systems available.