Introduction: In seniors, the prevalence of abdominal aortic aneurysms (AAA) is high (9-10%). We aim to characterize AAA growth rates (slow vs. rapid) to help inform management strategies, including individualized imaging surveillance frequency. Hypothesis: Modeling thrombosis may improve the characterization of AAAs' growth status. Methods: 3D geometrical AAA models with and without thrombosis (vessel lumen only) were generated for 70 human subjects using available contrast-enhanced CTA data. AAA growth rates were categorized as slow (< 5 mm/year) or rapid (≥ 5 mm/year) based on serial imaging. Python scripts were used to calculate geometrical parameters (83) with and without thrombosis. Patient-specific relevant health information was retrieved through a review of medical records. Support vector machine (SVM), a well-established machine learning method, was run with 10-fold cross-validation (100 iterations) to assess the predictive accuracy. Results: Among 70 AAAs studied, the ratio between rapidly-growing and slowly-growing was nearly 1:2. The combination of antihypertensive medication, coronary artery disease, juxta-aneurysm aortic size, and five geometrical parameters quantifying the extent of thrombosis provided the best accuracy for AAA's growth status. The area under receiving operating curve (AUROC) was 0.85, and total accuracy was 0.81, with 57% and 93% of rapidly- and slowly-growing AAAs correctly identified, respectively. Excluding patients with aneurysm thrombus, the AUROC and accuracy in predicting rapidly-growing AAAs decreased to 0.82 and 48%, respectively. Conclusions: machine-learning-based predictive modeling appears feasible for characterizing AAA's growth rate status. Manual aortic image segmentation, required for data analytics, is labor-intensive (on average, 1 hour). Leveraging artificial intelligence-based segmentation methodology may provide an automated solution to improve workflow and feasibility.
Objective: The aim of this study was to investigate the midterm outcomes of fenestrated and branched endovascular aortic repair (FB-EVAR) of pararenal (PRA) and thoracoabdominal aortic aneurysms (TAAAs). Summary Background Data: FB-EVAR has been associated with decreased morbidity compared to open repair, but there is limited midterm data. Methods: A total of 430 patients (302 males, mean age 74 ± 8 years) treated by FB-EVAR were enrolled in a prospective, nonrandomized investigational device exemption study. Endpoints included 30-day mortality and major adverse events (MAEs), freedom from all cause and aortic-related mortality, target vessel patency, and freedom from secondary intervention and target vessel instability. Results: There were 133 PRAs and 297 TAAAs with 1673 renal-mesenteric arteries incorporated by fenestrations or directional branches (3.9 ± 0.5 vessels/patient). At 30 days or within the hospital stay if longer than 30 days, there were 4 (0.9%) deaths. MAEs included new-onset dialysis in 8 patients (2%), permanent paraplegia or stroke in 10 patients each (2%), and respiratory failure requiring tracheostomy in 2 patients (0.5%). After a mean follow-up of 26 ± 20 months, there were 3 (0.7%) aortic-related deaths from SMA stent occlusion, gastrointestinal hemorrhage, or complications of open arch repair. At 5 years, freedom from all-cause and aortic-related mortality were 57% ± 5% and 98% ± 1%, respectively. Freedom from secondary intervention was 64% ± 4%, primary target vessel patency was 94% ± 1%, and freedom from target vessel instability was 89% ± 2% at same interval. One patient (0.2%) had nonfatal aneurysm treated using endovascular repair. Conclusion: FB-EVAR is safe and effective for treatment of PRA and TAAAs with low rate of aortic-related mortality and aneurysm rupture on midterm follow-up.
Introduction: Abdominal aortic aneurysms (AAA) are common among individuals over age 65 with a prevalence of 9%. Most AAAs are small and require surveillance imaging to monitor size and growth rates. Tools capable of predicting growth rates would be clinically useful. Hypothesis: We investigated how computational hemodynamics derived from CT angiography (CTA) differentiated slow and rapid-growing AAAs. Methods: Using readily available computing power in the clinical workflow, 3D models were generated for 25 subjects with AAA from available 3D CTA data. AAA growth rates were categorized as slow ( less than 5 mm/year) or rapid (greater than 5 mm/year) based on serial imaging. A geometrical analysis was performed using 7 indices (Volume, Surface Area, Length, Max/Min radius, Expansion Ratio [Mean radius/vessel radius], Proximal vessel area, Voronoi diagram-based metrics) for each AAA. Computational hemodynamics were performed using commercial software (ANSYS-Fluent). Computational hemodynamics were completed for all cases (see Fig. 1). In-house software assessed wall shear stress-(WSS) and vortex-based hemodynamics. Support vector machine (SVM) was run with cross-validation (50 iterations) to assess predictive strength using these 16 parameters. Results: Among 25 AAAs studied, 7 were rapid and 18 were slow-growing. The combination of proximal vessel area, spatiotemporally averaged WSS, and spatially averaged OSI provided the best accuracy for growth differentiation. The area under receiving operating curve (AUROC) and total accuracy are 0.770 and 0.765, respectively, with 48% and 86% of rapid and slow-growing AAAs correctly identified, respectively. Conclusions: Computational hemodynamics appears feasible with reasonable growth rate prediction. With optimization, this tool may enable resource utilization refinement for imaging surveillance strategies by distinguishing rapid from slow-growing AAAs.
Objective: The objective of this study was to review the learning curve for fenestrated-branched endovascular aortic repair (F-BEVAR) of pararenal and thoracoabdominal aortic aneurysms (TAAAs). Methods: We reviewed the clinical data of 334 consecutive patients (255 males, mean age 75 6 7 years) who underwent F-BEVAR between 2007 and 2016 in a single institution. Outcomes were analyzed in four quartiles of experience (Q1-Q4). Study outcomes included trends in patient characteristics, device design, procedural variables, 30-day mortality, and major adverse events (MAEs). Results: There were 178 patients (53%) treated for pararenal aneurysms and 156 (47%) for TAAAs. During the study period, there was a statistically significant increase in the proportion of TAAAs and in the number of vessels incorporated. Despite this, there was a steady decrease in 30-day mortality (6% in Q1 to 0% in Q4; P < .04) and in the rate of MAEs (60% in Q1 to 29% in Q4; P < .001). By linear regression analysis, there was significant decline in estimated blood loss (1358 6 1517 mL in Q1 to 486 6 520 mL in Q4; P < .001), total operating time (325 6 116 minutes in Q1 to 248 6 92 minutes in Q4; P < .001), total fluoroscopy time (121 6 59 minutes in Q1 to 85 6 39 minutes in Q4; P < .001), contrast volume (201 6 92 mL in Q1 to 160 6 61 mL in Q4; P = .002), and radiation dose (4141 +/- 2570 mGy in Q2 to 2543 +/- 1895 mGy in Q4; P < .001). Independent predictors of MAEs were total operating time (odds ratio [OR], 1.6; 95% confidence interval [CI], 1.3-1.8; P < .001), Society for Vascular Surgery total score (OR, 1.1; 95% CI, 1.02-1.2; P = .009), and quartile 1 (OR, 3.0; 95% CI, 1.7-5.2; P < .001). Conclusions: This study demonstrates significant improvement in perioperative mortality, MAEs, procedural variables, and secondary interventions in patients treated by F-BEVAR, despite the increase in complexity of aneurysm pathology during the study period. Also, better patient selection contributed to improve outcomes.
Objective: The objective of this study was to evaluate outcomes of directional branches using self-expandable stent grafts (SESGs) or balloon-expandable stent grafts (BESGs) during fenestrated-branched endovascular aneurysm repair of thoracoabdominal aortic aneurysms. Methods: Patients treated by fenestrated-branched endovascular aneurysm repair were enrolled in a prospective study from 2014 to 2018. We included in the analysis patients who had target vessels incorporated by directional branches using either SESG (Fluency [Bard, Covington Ga] or Gore Viabahn [W. L. Gore & Associates, Flagstaff, Ariz]) or BESG (Gore VBX). Target artery instability (TAI) was defined by a composite of any stent stenosis, separation, or type IC or type IIIC endoleak requiring reintervention and stent occlusion, aneurysm rupture, or death due to target artery complication. End points included technical success, target artery patency, freedom from TAI, freedom from type IC or type IIIC endoleak, and freedom from target artery reintervention. Results: There were 126 patients (61% male; mean age, 73 +/- 8 years) included in the study. A total of 335 renal-mesenteric arteries were targeted by directional branches using SESGs in 62 patients and 176 arteries or BESGs in 54 patients and 159 arteries. Patients in both groups had similar thoracoabdominal aortic aneurysm classification and aneurysm and target artery diameter, but SESG patients had significantly (P < .05) shorter stent length (-7 mm) and larger stent diameter (+1 mm) and more often had adjunctive bare-metal stents (72% vs 15%). Technical success was achieved in 99% of patients, with one 30-day death (0.7%). Mean follow-up was significantly longer among patients treated by SESGs compared with BESGs (23 +/- 12 months vs 8 +/- 8months; P < .0001). TAI occurred in 27 directional branches (8%), including 11 type IC endoleaks (2 SESGs, 9 BESGs), 10 stenoses (3 SESGs, 7 BESGs), 4 occlusions (3 SESGs, 1 BESGs), 4 type IIIC endoleaks (2 SESGs, 2 BESGs), and 1 stent separation (SESG), resulting in 20 target artery reinterventions in 16 patients (5 SESGs and 11 BESGs). At 1 year, SESGs had higher primary patency (97% +/- 2% vs 96% +/- 2%; P = .004), freedom from TAI (96% +/- 2% vs 88% +/- 3%; P < .0001), freedom from type IC or type IIIC endoleaks (98% +/- 1% vs 92% +/- 3%; P = .0004), and freedom from target artery reinterventions (98% +/- 1% vs 88% +/- 4%; P < .0001) compared with BESGs. There was no difference in secondary patency for SESGs and BESGs (98% +/- 1% vs 99% +/- 1%; P = .75). Factors associated with TAI were large stent diameter (odds ratio, 0.6; P < .0001) and use of VBX stent graft (odds ratio, 6.5; P < .0001). Conclusions: Directional branches were associated with high technical success and low rates of stent occlusion, independent of stent type. However, primary patency, freedom from TAI, and freedom from type IC or type IIIC endoleaks was lower for BESGs compared with SESGs.
The aim of this study was to review the clinical outcomes for patients treated for pararenal (PRA) and thoracoabdominal aortic aneurysms (TAAAs) by fenestrated–branched endovascular aortic repair (F-BEVAR) using preloaded systems (PLS).
Objective: Upper extremity (UE) access is frequently used during fenestrated-branched endovascular aortic repair (F-BEVAR) to facilitate catheterization of downgoing vessels. Limitations include risk of cerebral embolization and of UE arterial or peripheral nerve injury. The aim of this study was to assess outcomes of F-BEVAR using UE access. Methods: We reviewed the clinical data of 334 consecutive patients (74% males; mean age 75 +/- 8 years) treated by F-BEVAR for thoracoabdominal aortic aneurysms or pararenal aortic aneurysms between 2007 and 2016. Patients who underwent F-BEVAR with an UE approach for catheterization of the renal and/or mesenteric arteries were included in the study. End points were technical success, mortality, and a composite of access-related complications including cerebral embolization (stroke/transient ischemic attack), peripheral nerve injury, and axillary-brachial arterial complications requiring intervention. Results: There were 243 patients (73%) treated by F-BEVAR with UE access, including 147 patients (60%) with thoracoabdominal aortic aneurysms and 96 patients (40%) with pararenal aortic aneurysms. A total of 878 renalemesenteric arteries were incorporated by fenestrations or branches with a mean of 3.6 +/- 0.8 vessels per patient. All patients had surgical exposure of the brachial artery. The left side was selected in 228 (94%) and the right side in 15 (6%). The technical success of target vessel incorporation was achieved in 99% of patients (870 of 878). Arterial closure was performed using primary repair in 213 patients (88%) or bovine patch angioplasty in 29 (12%). Patch closure was required in 13% of patients (21 of 159) treated by 10-to 12F sheaths and 8% (7 of 83) of those who had 7-to 8F sheaths (P = .19). There were six deaths (2.5%) at 30 days or within the hospital stay, none owing to access-related complications. Major access-related complication occurred in eight patients (3%), with no difference between the 10-to 12F (6 of 159 [4%]) or 7-to 8F sheaths (2 of 83 [2%]; P = .45). Two patients (1%) had transient median nerve neuropraxia, which resolved within 1 year. One patient (0.5%) required surgical evacuation of an access site hematoma. There were no UE arterial pseudoaneurysms, occlusions, or distal embolizations. Five patients (2%) had strokes (three minor, two major), occurring more frequently with right side (2 of 15 [13%]) as compared with left-sided access (3 of 228 [1%]; P = .03). After a mean follow-up of 38 +/- 15 months, there were no other access-related complications or reinterventions. Conclusions: UE arterial access with surgical exposure was associated with a low rate of complications in patients treated with F-BEVAR. Closure with patch angioplasty is frequently needed, but there were no arterial occlusions, pseudoaneurysms, or distal embolizations requiring secondary procedures.
Upper extremity (UE) access during fenestrated-branched endovascular aortic repair (F-BEVAR) facilitates catheterization of mesenteric arteries but carries added risk of arterial injury and neurologic complications. The aim of this study was to assess outcomes of F-BEVAR using UE access. We reviewed the clinical data of 334 consecutive patients treated by F-BEVAR (2007-2016). Patients who had procedures with UE arterial access for renal-mesenteric catheterization were included in the study. End points were technical success, mortality, stroke, peripheral nerve injury, UE arterial complications (dissection, thrombosis, hematoma requiring intervention, pseudoaneurysm, or distal embolization), and freedom from UE thrombosis or reintervention. There were 243 patients (74% male; mean age, 75 ± 8 years) treated for 148 thoracoabdominal and 95 pararenal aortic aneurysms using UE arterial access. A total of 838 renal-mesenteric arteries were incorporated by fenestrations or branches (3.4 ± 0.3 vessels/patient). UE arterial access was performed using surgical exposure of the proximal brachial artery in 171 patients, distal brachial artery in 62, or infraclavicular axillary artery in nine. Access was left-sided in 228 patients (94%) and right-sided in 15 (6%). Large-profile sheaths (10F-12F) were used in 159 patients (66%) and smaller profile (7F-8F) in 84 (34%). Technical success of target vessel incorporation was achieved in 99% (829 of 838). Thirty-day mortality was 2.5% (6 of 243). UE arterial complications occurred in 8 patients (4%), including focal dissection in 5 (2%), and transection, in situ thrombosis or hematoma requiring surgical evacuation in 1 patient each. Flow-limiting UE arterial lesions were diagnosed intraoperatively and successfully treated by patch angioplasty in six patients and interposition vein graft in one. Two patients (1%) developed UE peripheral nerve neurapraxia. There were no pseudoaneurysms or distal embolizations. Four patients (2%) had stroke (3 minor, 1 major), which were more frequent with right-sided compared to left-sided UE arterial access (2 [13%] vs 2 [0.9%]; P < .001). Stroke was not associated with type of aortic arch, sheath profile, or presence of subclavian artery calcification or partial thrombus (P > .05). Mean follow-up was 38 ± 15 months. There were no late UE arterial stenoses, thromboses, access-related complications, or reinterventions. UE arterial access using surgical exposure and large-diameter sheaths was associated with low rates of complications, stroke, and peripheral nerve injuries in patients treated by F-BEVAR. Left-sided UE access was associated with lower stroke rates.
This study investigated changes in health-related quality of life (QOL) in patients treated for pararenal (PRA) and thoracoabdominal aortic aneurysms (TAAAs) with fenestrated-branched endovascular aortic repair (F-BEVAR). A total of 165 patients (114 male; mean age, 75 ± 7 years) were enrolled in a prospective, nonrandomized single-center study using manufactured F-BEVAR (2013-2016). Patient health-related QOL measures were assessed using the Short-Form 36 Health Survey questionnaire prior to treatment and at 1 month, 6 months, and yearly follow-up. Physical component scores (PCS) and mental component scores were compared to historical results of patients enrolled in the EVAR 1 trial who were treated by open surgical repair (OSR) or standard endovascular aortic repair (EVAR) for AAAs. There were 58 PRAs, 52 extent IV and 55 extent I to III TAAAs. A total of 646 renal-mesenteric arteries were incorporated by fenestrations or branches with mean of 3.9 ± 0.2 vessels per patient. Technical success for branch vessel incorporation was 99.6%. There were no 30-day or in-hospital deaths, conversions to OSR, or aortic-related deaths. Mean follow-up was 14 ± 9 months. A total of 531 QOL questionnaires were completed (3.2 ± 0.8/patient). Follow-up >30 days was obtained in all patients, >6 months in 130, >12 months in 96, and >24 months in 38. Patient survival was 95% ± 2% at 1 year and 82% ± 4% at 2 years, without a difference between groups. PCS declined after the operation in all aneurysm groups, returning to baseline at 12 months for patients with PRAs but not for those with TAAAs (P < .05). Patients with PRAs had significantly higher PCS at 12 months when compared to those with TAAAs (P < .001, Fig 1). There were no changes in mental component scores. The only independent predictor for decline in PCS was a higher PCS prior to the operation (P < .0001). Major adverse events were associated with early decline in PCS at 30 days (P < .05) but were not associated with late QOL changes in subsequent evaluations. Reinterventions had no effect on QOL measures. Overall, patients treated by FEVAR had similar changes in QOL measures when compared to historical OSR and EVAR controls (Fig 2). PCS were lower at 12 months for patients treated by FEVAR for TAAAs compared to OSR or EVAR controls. F-BEVAR was associated with significant decline in PCS, which returned to baseline values at 12 months in patients with PRAs but not in those with TAAAs. Patients treated for PRAs had similar changes in QOL compared to those treated for AAAs.Fig 2Comparison of Short Form 36 Health Survey (SF-36) physical component score (PCS) score among patients who underwent to fenestrated-branched endovascular aortic repair (F-BEVAR; Mayo Clinic series) and EVAR1 trial groups (EVAR1 EVAR and EVAR1 open repair). EVAR, Endovascular aortic aneurysm repair.View Large Image Figure ViewerDownload Hi-res image Download (PPT)
OBJECTIVE:The goal of this study was to investigate the correlation between atherothrombotic aortic wall thrombus (AWT) and clinical outcomes in patients treated by fenestrated-branched endovascular aortic repair (F-BEVAR) and present a new classification system for assessment of AWT burden. METHODS:The clinical data of 301 patients treated for pararenal and thoracoabdominal aortic aneurysms (TAAAs) by F-BEVAR was reviewed. The study excluded 89 patients with extent I to III TAAA because of extensive laminated thrombus within the aneurysm sac. Computed tomography angiograms were analyzed in all patients to determine the location, extent, and severity of atherothrombotic AWT. The aorta was divided into three segments: ascending and arch (A), thoracic (B) and renal-mesenteric (C). Volumetric measurements (cm3) of AWT were performed using TeraRecon software (TeraRecon Inc, Foster City, Calif). These volumes were used to create an AWT index by dividing the AWT volume from the total aortic volume. A classification system was proposed using objective assessment of the number of affected segments, thrombus type, thickness, area, and circumference. Clinical outcomes included 30-day mortality, neurologic and gastrointestinal complications, renal events (Risk, Injury, Failure, Loss of kidney function, End-stage renal disease [RIFLE]), and solid organ infarction. RESULTS:The study included 212 patients, 169 men (80%) and 43 women (20%), with a mean age of 76 ± 7 years. A total of 700 renal-mesenteric arteries were incorporated (3.1 ± 1 vessels/patient). AWT was classified as mild in 98 patients (46%) and was considered moderate or severe in 114 (54%). There was one death (0.5%) at 30 days. Solid organ infarction was present in 50 patients (24%), and acute kidney injury occurred in 45 patients (21%) by RIFLE criteria. An association with higher AWT indices was found for time to resume enteral diet (P = .0004) and decline in renal function (P = .0003). Patients with acute kidney injury 2 by RIFLE criterion had significantly higher (P = .002) AWT index scores in segment B. Spinal cord injury occurred in three patients (1.4%) and stroke in four (1.9%), but were not associated with the AWT index. Severity of AWT using the new proposed classification system correlated with the AWT index in all three segments (P < .001). Any of the end points occurred in 35% of the patients with mild and in 53% of those with moderate or severe AWT (P = .016). CONCLUSIONS:AWT predicts solid organ infarction, renal function deterioration, and longer time to resume enteral diet after F-BEVAR of pararenal and type IV TAAAs. Evaluation of AWT should be part of preoperative planning and decision making for selection of the ideal method of treatment in these patients.
Purpose: To review outcomes of continuous motor/somatosensory-evoked potential (MEP/SSEP) monitoring, cerebrospinal fluid drainage, and selective use of iliofemoral conduits in patients undergoing endovascular repair of descending thoracic aneurysm (DTA) and thoracoabdominal aortic aneurysms (TAAAs). Methods: The clinical data of 49 patients (mean age 75±8 years; 38 men) who underwent endovascular repair of DTA and TAAAs (2011–2014) were reviewed. All patients had cerebrospinal fluid drainage, permissive hypertension (mean arterial pressure ≥80 mm Hg), and MEP/SSEP monitoring. There were 44 (90%) patients with TAAAs and 5 (10%) with DTA. Types I and II TAAAs were repaired in staged procedures. Iliofemoral conduits were used for small iliac arteries and to minimize time of lower extremity ischemia in patients with difficult anatomy. In patients with changes in MEP/SSEPs, a standardized protocol was employed to optimize spinal cord perfusion and restore lower extremity blood flow. Endpoints were mortality, spinal cord injury (SCI), and lower extremity ischemic complications. Results: Sixteen (33%) patients had staged TAAA repair. A total of 163 visceral arteries were targeted by fenestrations and branches (mean 3.7±1.0 vessels/patient). Temporary iliofemoral conduits were used in 16 limbs/14 patients. A stable MEP/SSEP was achieved in all patients. Thirty-one (63%) patients had a ≥75% decrease in MEP/SSEP amplitude in 50 limbs starting on average 75±28 minutes after obtaining vascular access. MEP/SSEP amplitude improved with maneuvers in 12 (39%) patients and returned to baseline with restoration of lower extremity flow in all except 1 patient who developed immediate SCI. Thirty-day mortality was 4%. Three (6%) patients had SCI, 2 permanent and 1 temporary at 14 days. There were no lower extremity ischemic complications. Conclusion: Neuromonitoring predicted immediate SCI and allowed use of a protocol to optimize spinal cord and lower extremity perfusion during complex endovascular aortic repair. Larger clinical experience is needed to evaluate the efficacy of neuromonitoring to prevent SCI.
This case video highlights the treatment of an extent II thoracoabdominal aortic aneurysm secondary to a chronic type B dissection using a patient-specific, manufactured four-vessel fenestrated-branched endograft under a physician-sponsored investigational device exemption study. The case video entails preoperative planning, the endovascular execution, and outcome. A specific challenge demonstrated in this case is the technique used to cross the chronic dissection flap to access the isolated right renal artery, which was perfused by the false lumen.
PURPOSE:The study purpose was to review the outcomes of patients treated for thoracoabdominal aortic aneurysms using endovascular repair with fenestrated and branched stent-grafts in a single center.METHODS:We reviewed the clinical data of the first 185 consecutive patients (134 male; mean age, 75 ± 7 years) treated for thoracoabdominal aortic aneurysms using fenestrated and branched stent-grafts. Graft design evolved from physician-modified endografts (2007-2013) to off-the-shelf or patient-specific manufactured devices in patients enrolled in a prospective physician-sponsored investigational device exemption protocol (NCT 1937949 and 2089607). Outcomes were reported for extent IV and extent I to III thoracoabdominal aortic aneurysms, including 30-day mortality, major adverse events, patient survival, primary target vessel patency, and reintervention.RESULTS:A total of 112 patients (60%) were treated for extent IV thoracoabdominal aortic aneurysms, and 73 patients (40%) were treated for extent I to III thoracoabdominal aortic aneurysms. Demographics and cardiovascular risk factors were similar in both groups. A total of 687 renal-mesenteric arteries (3.7 vessels/patient) were targeted by 540 fenestrations and 147 directional branches. Technical success was 94%. Thirty-day mortality was 4.3%, including a mortality of 1.8% for extent IV and 8.2% for extent I to III thoracoabdominal aortic aneurysms (P = .03). Mortality decreased in the second half of clinical experience from 7.5% to 1.2%, including a decrease of 3.3% to 0% for extent IV thoracoabdominal aortic aneurysms (P = .12) and 15.6% to 2.4% for extent I to III thoracoabdominal aortic aneurysms (P = .04). Early major adverse events occurred in 36 patients (32%) with extent IV thoracoabdominal aortic aneurysms and 26 patients (36%) with extent I to III thoracoabdominal aortic aneurysms, including spinal cord injury in 2 patients (1.8%) and 4 patients (3.2%), respectively. Mean follow-up was 21 ± 20 months. At 5 years, patient survival (56% and 59%, P = .37) and freedom from any reintervention (50% and 53%, P = .26) were similar in those with extent IV and extent I to III thoracoabdominal aortic aneurysms. Primary patency was 93% at 5 years.CONCLUSIONS:Endovascular repair of thoracoabdominal aortic aneurysms can be performed with high technical success and low mortality and morbidity. However, the need for secondary reinterventions and continued graft surveillance represents major limitations compared with results of conventional open surgical repair. Long-term follow-up is needed before the widespread use of these techniques in younger or lower-risk patients.
Embolization of atheromatous debris is a known cause of morbidity and mortality after fenestrated and branched endovascular aortic repair (F-BEVAR). The aim of this study was to correlate measurements of aortic wall thrombus (AWT) volume with outcomes of F-BEVAR. The clinical data of 301 patients treated for pararenal (PRA) and thoracoabdominal aortic aneurysms (TAAAs) with F-BEVAR were entered into a prospective database (2007-2015). Volumetric measurements of AWT were performed using computed tomography angiography (CTA) and TeraRecon Software (Fig) in nonaneurysmal segments (≤4 cm) of the arch (A), descending thoracic (B), and suprarenal aorta (C). Patients with type I-III TAAAs were excluded from the analysis. AWT was classified as mild, moderate, or severe using a 0 to 10 score system, which was based on the number of affected segments and thrombus type, thickness, area, and circumference. End points were 30-day mortality, neurologic (stroke, spinal cord injury), renal (RIFLE and AKIN criteria), and gastrointestinal events (pancreatitis, ileus and ischemic bowel). and evidence of solid organ infarction by CTA. A composite end point of any of these events was also analyzed. There were 157 patients treated for PRAs and 55 patients treated for type IV TAAAs. A total of 634 renal-mesenteric arteries were incorporated by fenestrations or branches (3.09 ± 0.96 vessels/patient). There was one (0.5%) 30-day mortality. Moderate or severe AWT was present in 114 patients (54%). AWT volume was associated with higher rates of renal function deterioration and more liver, splenic and kidney infarcts (P < .05). The proposed classification correlated with measurements of AWT volume in all the three segments. Clinical characteristics, extent of repair, and procedural variables were similar in patients with mild, moderate, or severe AWT. The composite end point occurred in 35% of patients with mild, 52% of moderate, and 56% of severe AWT (P = .016). There was no association for neurologic events, but six of the seven events occurred in patients with moderate or severe AWT. Patients with moderate or severe AWT experienced more renal function deterioration and had more liver, splenic, and kidney infarcts (P < .05). Any solid organ infarct occurred in 16% of patients with mild, 27% of moderate, and 36% of severe AWT (P = .018). For gastrointestinal events, there was no association. AWT predicts renal function deterioration and solid organ infarcts after F- BEVAR. Evaluation of AWT should be an essential part of F-BEVAR planning and should affect selection of open vs endovascular approach of complex aortic aneurysms.TableVolumetric analysisaQualitative analysisaAdverse eventSegmentNoYes (event)P valueMild 0-3 (n = 98)Moderate 4-8 (n = 75)Severe 9-10 (n = 39)P valueAWT index,b %B20.2 ± 4.122.4 ± 3.427.3 ±5.2<.001C23.6 ± 6.726.0 ± 5.831.6 ±8.3<.001RIFLE (n = 45)B21.8 ± 4.524.5 ± 5.7.00216 (16)16 (21)13 (33).034C25.8 ± 7.226.8 ± 8.1.46AKIN (n = 48)B22.01 ± 4.423.7 ± 6.0.03817 (17)17 (23)14 (36).024C25.9 ± 7.126.5 ± 8.2.64Infarction Spleen (n = 25)B22.0 ± 4.724.8 ± 5.4.0116 (6)14 (19)5 (13).098C25.6 ± 7.329.1 ± 7.5.033 Kidney (n = 35)B22.0 ± 4.624.1 ± 5.8.02511 (11)12 (16)12 (31).0093C25.5 ± 7.128.7 ± 8.4.031 Liver, kidney, spleen (n = 50)B21.9 ± 4.624.1 ± 5.3.00516 (16)20 (27)14 (36).0108C25.4 ± 7.228.1 ± 7.6.029aData are presented as mean ± standard deviation or number (%). Italic values indicate statistical significance.bAWT index = (AWT volume/total aortic volume) × 100. Open table in a new tab
Fenestrated and branched endovascular aortic repair (F-BEVAR) has been increasingly performed using the supraceliac aorta for sealing zone with 4-vessel incorporation to decrease rates of late branch-related complications from progression of aortic disease. The aim of this study was to investigate outcomes of F-BEVAR using supraceliac sealing zone to treat pararenal (PRA) and thoracoabdominal aortic aneurysms (TAAAs). A total of 100 patients (75 male, mean age 78 ± 7 years old) with PRA and TAAAs were enrolled in a prospective, nonrandomized single-center study using manufactured F-BEVAR (November 2013-October 2015; ClinicalTrials.gov NCT1937949/02089607). Stent design was based on supraceliac sealing zones in all patients, with ≥4 vessels in 97 using a patient-specific or off-the-shelf endograft. Spinal cord injury (SCI) prevention was done using permissive hypertension (mean arterial pressure >80 mm Hg), cerebrospinal fluid drainage, neuromonitoring, and selective use of iliofemoral conduits for all patients with >4 cm of supra celiac coverage. Staged repair was used for all Type I-II TAAAs. Follow-up included clinical examination, laboratory studies, duplex ultrasound, and computed tomography imaging at discharge, 1 month, 6 months, and yearly. An independent data safety monitoring board and clinical event committee was used to adjudicate events. End points were mortality, major adverse events (MAEs), freedom from reintervention, branch vessel occlusion, type Ia/III endoleak, sac aneurysm enlargement, and aneurysm rupture. Aneurysm extent included 37 PRAs, 35 type IV, and 28 type I-III TAAAs, with mean diameter of 65 ± 8 mm. A total of 387 renal-mesenteric arteries were incorporated by 276 fenestrations, 98 branches, and 13 scallops, with mean of 3.9 ± 0.6 vessels/patient. Technical success of target vessel stenting was 99% (385 of 387). There were no 30-day or in-hospital deaths, dialysis, or conversions. MAEs occurred in 19 patients, with an identical rate for PRAs and TAAAs (19% each, Table). Three patients had SCI (2 paraplegia, 1 paraparesis), of which two had complete reversal. Mean length of hospital stay was 5 ± 3 days. Follow-up was >30 days in all patients, >6 months in 75 and >12 months in 51. There were no patients lost to follow-up. After a mean follow-up of 9 ± 4 months, there were 13 reinterventions, 5 type Ia/III endoleaks, 4 renal stent occlusions, 4 late unrelated deaths, 2 sac enlargements, and no ruptures. F-BEVAR using supraceliac sealing zones and 4-vessel designs is safe and can be performed with excellent early outcomes. Long-term follow-up is needed to assess the impact of more extensive 4-vessel designs on late device-related complications and progression of aortic disease.TablePararenal aneurysms (n = 37)Thoracoabdominal aneurysms (n=63)P value30-day outcomesNo. of events and percent Any MAE719719.99Any cause mortality0000–Myocardial infarction3835.7Acute kidney injury2523.58Respiratory failure0023.27Spinal cord injury1323.13Blood loss >1 liter13711.131-year Kaplan-Meier estimatesNo. of events and percent survival ± standard deviation Patient survival493 ± 60100.86 Freedom from reintervention589 ± 6883 ± 7.87 Freedom from type Ia/III endoleak297 ± 2398 ± 2.86 Freedom from vessel occlusion (n = 387)399 ± 2199 ± 2.99 Freedom from sac growth199 ± 2199 ± 2.99MAE, Major adverse event Open table in a new tab
PURPOSE:To investigate outcomes of manufactured fenestrated and branched endovascular aortic repair (F-BEVAR) endografts based on supraceliac sealing zones to treat pararenal aortic aneurysms and thoracoabdominal aortic aneurysms (TAAAs). METHODS:A total of 127 patients (91 male; mean age, 75 ± 10 years old) were enrolled in a prospective, nonrandomized single-center study using manufactured F-BEVAR (November 2013-March 2015). Stent design was based on supraceliac sealing zone in all patients with ≥ four vessels in 111 (89%). Follow-up included clinical examination, laboratory studies, duplex ultrasound, and computed tomography imaging at discharge, 1 month, 6 months, and yearly. End points adjudicated by independent clinical event committee included mortality, major adverse events (any mortality, myocardial infarction, stroke, paraplegia, acute kidney injury, respiratory failure, bowel ischemia, blood loss >1 L), freedom from reintervention, and branch-related instability (occlusion, stenosis, endoleak or disconnection requiring reintervention), target vessel patency, sac aneurysm enlargement, and aneurysm rupture. RESULTS:There were 47 pararenal, 42 type IV, and 38 type I-III TAAAs with mean diameter of 59 ± 17 mm. A total of 496 renal-mesenteric arteries were incorporated by 352 fenestrations, 125 directional branches, and 19 celiac scallops, with a mean of 3.9 ± 0.5 vessels per patient. Technical success of target vessel incorporation was 99.6% (n = 493/496). There were no 30-day or in-hospital deaths, dialysis, ruptures or conversions to open surgical repair. Major adverse events occurred in 27 patients (21%). Paraplegia occurred in two patients (one type IV, one type II TAAAs). Follow-up was >30 days in all patients, >6 months in 79, and >12 months in 34. No patients were lost to follow-up. After a mean follow-up of 9.2 ± 7 months, 23 patients (18%) had reinterventions (15 aortic, 8 nonaortic), 4 renal artery stents were occluded, five patients had type Ia or III endoleaks, and none had aneurysm sac enlargement. Primary and secondary target vessel patency was 96% ± 1% and 98% ± 0.7% at 1 year. Freedom from any branch instability and any reintervention was 93% ± 2% and 93% ± 2% at 1 year, respectively. Patient survival was 96% ± 2% at 1 year for the entire cohort. CONCLUSIONS:Endovascular repair of pararenal aortic aneurysms and TAAAs, using manufactured F-BEVAR with supraceliac sealing zones, is safe and efficacious. Long-term follow-up is needed to assess the impact of four-vessel designs on device-related complications and progression of aortic disease.
This study reviewed the outcomes of percutaneous endovascular aortic repair (PEVAR) of complex aortic aneurysms using large-diameter sheaths for thoracic, fenestrated, and branched stent grafts. We reviewed the outcomes of all consecutive patients who underwent PEVAR of descending thoracic (DTA), thoracoabdominal (TAAA), pararenal (PRA) or aortoiliac aneurysms (AIAs) using large-diameter sheaths for placement of thoracic, fenestrated, or branched stent grafts. Patients treated by fenestrated and branched stent grafts were enrolled in prospective physician-sponsored investigational device exemption protocols. A percutaneous approach was selected in patients with <50% posterior, minimal anterior, or no calcification in the common femoral artery using standardized preclosure technique with two Perclose devices (Abbott Vascular Inc., Redwood City, Calif) in each femoral puncture site. End points were technical success, conversion to open femoral artery repair, 30-day mortality and major adverse events, and freedom from femoral access-site complications. There were 102 patients treated for 48 PRAs, 27 TAAAs, 19 DTAs, and 8 AIAs. A total of 171 femoral arteries were closed using preclosure technique. Transfemoral sheath size was 18F in four vessels (3%), 20F in 120 (70%), and ≥22F in 47 (27%). Eighty-three patients (81%) had visceral branch incorporation, which required brachial artery access using small incision in 48. Technical success for percutaneous transfemoral closure was 95% (162 of 171). Nine intraoperative failures were managed by open femoral conversion using primary repair in six, interposition graft in two, and patch angioplasty in one. Mean estimated blood loss was 444 ± 569 mL. There were no patients with uncontrolled puncture-related hemorrhage, retroperitoneal hematoma, or intra-operative hypotension. The 30-day mortality was 0.9% (one of 101) and 30-day rate of major adverse events was 15% (16 of 102). Spinal cord injury occurred in one patient (0.9%). Five (3%) access-related complications occurred, including femoral artery occlusion in three and hematoma or pseudoaneurysm in one each. Wound-related complications occurred in one patient (0.5%) who required open femoral artery conversion for exposure and repair. After a mean follow up of 1-year, freedom from femoral access-site complication was 97% ± 2%. PEVAR using the preclosure technique is safe and effective in select patients with complex aortic aneurysms who have minimal or no femoral calcifications and require large-diameter sheaths for thoracic, fenestrated, and branched stent grafts. Rate of puncture (3%) and wound-related complications (0.5%) is low, and no uncontrolled puncture-related hemorrhage, retroperitoneal hematoma, or systemic hypotension occurred in this series.
Objective: We previously reported that in situ rifampin-soaked grafts (ISRGs) were safe in select patients with aortic graft infections, with the best results in those with aortic graft enteric erosion or fistula (AGEF). This study evaluates the late results of ISRG for AGEF.Methods: From 1990 to 2008, 183 patients were treated for aortic graft infections (121 primary and 62 AGEF). We reviewed 54 patients treated for AGEF with a standard protocol, which included excision of the infected part of the graft, intestinal repair, ISRG with omental wrap, and long-term antibiotics. We excluded 8 patients with AGEF (13%) treated with axillofemoral grafts (AXFG, n = 5) or in situ femoral vein (n = 3) due to excessive perigraft purulence. Endpoints were early morbidity and mortality, late survival, reinfection, and graft-related complications.Results: There were 45 male patients and 9 female patients with a mean age of 69 9 years. Presentation was gastrointestinal bleeding in 33 patients, fever in 25 patients, and hemorrhagic shock in 10 patients. Other features were perigraft fluid in 29 patients and purulence in 9 patients. Forty-two patients (80%) had infections isolated to a portion of the graft body or limb, with the remainder of the graft well incorporated. Total graft excision was performed in 31 patients and partial excision in 23 patients. Total operating time was 6.2 +/- 1.9 hours. Postoperative complications occurred in 28 patients (52%), and there were 5 deaths (9%). Operative mortality was 2.3% in stable patients (1 of 44) and 40% in those with hemorrhagic shock (4 of 10; P < .001). The hospital stay was 20 18 days. Mean follow-up was 51 months (range, 3-197 months). Five-year patient survival, primary graft patency, and limb salvage rates were 59 +/- 8%, 92 +/- 5%, and 100%, respectively. There were no late graft-related deaths. There were two (4%) graft reinfections, one that was treated with axillofemoral bypass, and the other with perigraft fluid aspiration and oral antibiotic suppression.Conclusion: ISRGs with omental wrap and long-term antibiotics are associated with low reinfection rates in patients with AGEF who do not have excessive perigraft purulence. Graft patency and limb salvage rates are excellent. (J Vasc Surg 2011;53:99-107.)
We previously reported that in situ rifampin-soaked grafts (ISR) were safe in selected patients with aortic graft infections, with the best results in those with aortic graft enteric erosion or fistula (AGEF). This study evaluates the late results of ISR for AGEF. From 1990 to 2008 183 patients were treated for aortic graft infections (121 primary and 62 AGEF). We reviewed 54 patients treated for AGEF with a standard protocol, which included excision of the infected graft, intestinal repair, ISR with omental wrap, and long-term antibiotics. We excluded 8 AGEF patients (13%) treated with axillofemoral grafts (AXFG, n = 5) or femoral vein grafts (n = 3) due to excessive perigraft purulence. End-points were early morbidity and mortality, and late survival, reinfection and graft-related complication rates. There were 45 male and 9 female patients with mean age of 69 ± 9 years. Presentation was gastrointestinal bleeding in 30 patients, fever in 25, and hemorrhagic shock in 8. Other features were perigraft fluid/purulence in 42 patients and abscess in 5 (drained in 3). Excision of the entire graft was required in 38 patients, and 16 had partial excision to incorporated graft. Total operating time was 6 ± 4 hours. Postoperative complications occurred in 28 patients (52%), and there were 5 deaths (9%), 3 in patients with shock. The hospital stay was 24 ± 21 days. Five-year patient survival, primary graft patency, and limb salvage rates were 66 ± 7%, 88 ± 4% and 100%. There were no late graft-related deaths. After a median follow-up of 38 months, there was 1 (2%) graft reinfection treated with AXFG, 3 noninfected femoral aneurysms, and 5 graft limb thrombosis/restenosis requiring revision. In situ rifampin-soaked grafts with omental wrap and long-term antibiotics are associated with low reinfection rates (2%) in properly selected patients with AGEF who do not have excessive perigraft purulence. Graft patency and limb salvage rates are excellent.
Distal vein cuff interposition is often added to prosthetic infragenicular arterial reconstruction in an attempt to improve hemodynamics and patency rates. The purpose of this study was to compare the outcome of a precuffed expanded polytetrafluroethylene (ePTFE) graft with a vein-cuffed ePTFE graft for infragenicular bypass. We reviewed the clinical outcome of 77 patients with critical limb ischemia without available autologous vein conduits who underwent arterial reconstruction of 80 limbs to below-knee popliteal or tibioperoneal vessels using either ePTFE precuffed graft (precuffed group, 38 patients 40 limbs) or ePTFE vein-cuffed graft (vein-cuffed group, 39 patient, 40 limbs). Precuffed group patients were enrolled in a prospective cohort study. Vein-cuffed group patients consisted of consecutive case-matched patients operated on during the same study period. End points were primary graft patency and limb salvage rates. There were 42 males and 35 females with a mean age of 73.4 years (range, 44-92 years). Both groups were matched to demographics, risk factors for atherosclerosis, previous ipsilateral reconstruction, and location of the distal anastomosis. Proximal anastomosis was to the common (n = 68) or superficial (n = 12) femoral arteries. Distal anastomosis was to the below-knee popliteal (n = 28), anterior tibial (n = 12), posterior tibial (n = 15) and peroneal (n = 25) arteries. Operative mortality was 1.3%. Graft patency at dismissal was 90% and 95% in the precuffed and vein-cuffed groups, respectively. The mean follow-up was 25.7 months (range, 2.4-61 months). Primary patency rates at 1 and 3 years were 70% and 57% in the precuffed group, and 78% and 54% in the vein-cuffed group (p = 0.32). Limb salvage rates at 1 and 3 years were 97% and 70% in the precuffed group, and 95% and 81% in the vein-cuffed group (p = 0.49). Overall patient survival at 1 and 3 years was 81 % and 57%, respectively. In this case-control study, results of precuffed ePTFE graft were similar to those obtained with vein-cuffed ePTFE grafts. The precuffed ePTFE graft is an adequate alternative conduit for infragenicular arterial reconstruction in patients with critical limb ischemia and no available autologous veins.