Prospective nonrandomized study to evaluate cone beam computed tomography for technical assessment of standard and complex endovascular aortic repair.

OBJECTIVE: The objective of this study was to analyze the utility of cone beam computed tomography (CBCT) for technical assessment of standard and complex endovascular aneurysm repair (EVAR). METHODS: Data of consecutive patients who underwent standard or complex EVAR in 2016 and 2017 at our institution were entered into a prospective database and analyzed retrospectively. There were 154 patients (126 male; mean age, 74 ± 8 years) enrolled in a prospective study between 2016 and 2017. A total of 170 aortic procedures were investigated, including 85 fenestrated-branched EVARs (F-BEVARs), 42 abdominal and thoracic EVARs, 32 EVARs with iliac branch devices, and 11 aorta-related interventions. Technical assessment was done using CBCT with and without contrast enhancement, digital subtraction angiography (DSA), and computed tomography angiography (CTA). Patients with stage 3B or stage 4 chronic kidney disease had CBCT without contrast enhancement. Radiation exposure (mean dose-area product), effective dose (ED), and amount of iodine contrast agent were analyzed. End points were presence of any endoleak, positive findings warranting possible intervention (stent kink or compression, type I or type III endoleak, dissection, thrombus), and need for secondary intervention. RESULTS: Radiation exposure and amount of iodine contrast agent were significantly higher (P < .05) for F-BEVAR compared with other aortic procedures (174±101 Gy∙cm2 vs 1135±113 Gy∙cm2 and 144±60 mL vs 122±49 mL). ED averaged 74±36 mSv for the aortic procedure, 18 ± 18 mSv for fluoroscopy, 7 ± 7 mSv for DSA acquisition, 15±7 mSv for CBCT, and 34±17 mSv for CTA imaging (P < .001). Endoleak detection was significantly higher (P < .001) with CBCT (53%) compared with DSA (14%) and CTA (46%). CBCT identified 52 positive findings in 43 patients (28%), higher for F-BEVAR compared with other aortic procedures (35% vs 16%; P = .01). Positive findings included stent compression or kink in 29 patients (17%), type I or type III endoleak in 16 patients (10%), and arterial dissection or thrombus in 7 patients (5%). Of these, 28 patients (18%) had positive findings that prompted an intraoperative (17%) or delayed intervention (1%). Another 15 patients (10%) with minor positive findings were observed with no clinical consequence. DSA alone would not have detected positive findings in 34 of 43 patients (79%), including 21 patients (49%) who needed secondary interventions. CTA diagnosed two (1%) additional endoleaks requiring intervention (one type IC, one type IIIC) that were not diagnosed by CBCT. Replacing DSA and CTA by CBCT would have resulted in 53% ± 13% reduction in amount of iodine contrast agent and 55% ± 12% reduction in ED (P < .05). CONCLUSIONS: CBCT reliably detected positive findings prompting immediate revisions in nearly one of five patients, with the highest rates among F-BEVAR patients. Detection of any endoleak was higher with CBCT compared with DSA or CTA, but most endoleaks were observed. DSA alone failed to detect positive findings warranting revisions.

Preloaded Catheters and Guide-Wire Systems to Facilitate Catheterization During Fenestrated and Branched Endovascular Aortic Repair.

OBJECTIVE: 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). METHODS: We reviewed clinical data of 83 patients (64 male, mean age 75 ± 7 years) enrolled in a prospective study to investigate F-BEVAR. All patients had PLS, which included two catheters or two through-and-through guide wires with 12-Fr trans-brachial sheaths positioned in the descending thoracic aorta. Outcome measurements were technical success defined as successful deployment of the main fenestrated stent graft and cannulation of all target vessels, total endovascular time, total lower extremity ischemia time and complications, 30-day mortality, and major adverse events (MAEs). RESULTS: Aneurysm extent was PRA in 27 patients and TAAA in 56 (35 extent IV and 21 extent I-III). A total of 333 target vessels were incorporated with an average of 4 ± 0.4 vessels per patient. Technical success was 99.7%. Total endovascular time was 160 ± 51 min. Sixty-five (78%) patients had motor and somatosensory evoked potentials monitoring, and lower extremity ischemia time was 115 ± 42 min. There were no 30-day mortalities. Fifteen patients (18%) had MAEs, including three (3.6%) minor ischemic strokes. There were no upper extremity complications. All ischemic strokes occurred in female patients (3.6% vs. 0%, P = .001). One (1.2%) patient had paraplegia. CONCLUSION: This study shows high technical success and early lower limb reperfusion using PLS with trans-brachial access. The risk of stroke, especially in female patients, should be carefully assessed by review of preoperative arch imaging.

Comparison of Perioperative Outcomes of Patients with Iliac Aneurysms Treated by Open Surgery or Endovascular Repair with Iliac Branch Endoprosthesis.

BACKGROUND: Treatment of common and internal iliac aneurysms is usually done by open surgery. A novel iliac branch endoprosthesis (IBE) is commercially available with encouraging initial results. Our objective is to compare perioperative outcomes of patients with iliac aneurysms treated by open surgery (OS) versus endovascular repair with IBE. METHODS: The study was a retrospective, single-center review of patients who were treated for aortoiliac or isolated common and/or internal iliac artery aneurysms from 2014 to 2017. Patients with connective tissue disorders, infected grafts, or thoracoabdominal aneurysms were excluded. Primary outcomes were perioperative mortality, length of hospital (LOS) and intensive care unit (ICU) stay, estimated blood loss, need for red blood cell transfusion (RBC), and perioperative reinterventions. RESULTS: Sixty-seven patients (96% male) were treated with OS (n = 25, mean age 68 ± 8 years) or IBE (n = 42, mean age 73 ± 8 years; P = 0.02) with 1 symptomatic patient in each group. Perioperative mortality occurred in 1 patient in the OS group (4%), with no mortality in the IBE group (P = 0.37) Total LOS and ICU stay was higher for OS compared to IBE (total stay 7.5 ± 3.4 vs. 1.7 ± 1.4 days for IBE, P < 0.0001 and ICU LOS 3.3 ± 2.1 vs. 0.1 ± 0.4 days, P < 0.0001). Estimated blood loss was higher for patients undergoing OS (4,732 ± 2,540 mL) compared to patients treated with IBE (263 ± 451 mL, P < 0.0001), resulting in higher RBC transfusion requirements (1.5 ± 2.4 vs. 0.2 ± 0.8 units, P = 0.001). Five patients in the OS group had early procedure-related reinterventions, while 2 patients in the IBE group required reintervention for access site complications (20% vs. 4.7%, P = 0.09). CONCLUSIONS: Endovascular repair of iliac aneurysms with IBE is feasible and is associated with lower blood loss, LOS and ICU stay, and had lower RBC transfusion requirements. Cost analysis and long-term follow-up will be needed to define the value of this modality for iliac artery aneurysm repair.

Outcomes of upper extremity access during fenestrated-branched endovascular aortic repair.

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 renal-mesenteric 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.

Penetrating Aortic Ulcer and Intramural Hematoma.

Acute aortic syndromes include a variety of overlapping clinical and anatomic diseases. Penetrating aortic ulcer (PAU), intramural hematoma (IMH) and aortic dissection can occur as isolated processes or can be found in association. All these entities are potentially life threatening, so prompt diagnosis and treatment is of paramount importance. PAU and IMH lesions in the Stanford Type A distribution often require urgent open surgical repair. Lesions in the Stanford Type B distribution may be managed medically in the absence of symptoms or progression; however, a low threshold for endovascular or surgical treatment should be maintained. This review summarizes the clinical presentation, epidemiology, diagnosis, indications for treatment and endovascular strategies in patients with PAU or IMH.

Impact of onlay fusion and cone beam computed tomography on radiation exposure and technical assessment of fenestrated-branched endovascular aortic repair.

OBJECTIVE: The objective of this study was to analyze the impact of advanced imaging applications and cone beam computed tomography (CBCT) on radiation exposure of the patient and operator and detection of technical problems during fenestrated-branched endovascular aortic repair (F-BEVAR) for treatment of pararenal aneurysms and thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of 386 consecutives patients (289 male; mean age, 75 ± 8 years) treated by F-BEVAR for 196 pararenal aneurysms and 190 TAAAs (mean, 3.4 ± 0.9 targeted vessels/patient) between 2007 and 2017. Radiation exposure (cumulative air kerma) was analyzed in three fixed imaging systems used between 2007 and 2011 (system 1), 2012 and 2016 (system 2), and 2016 and 2017 (system 3). Onlay fusion and CBCT were available with systems 2 and 3, whereas digital zoom with fusion overlay was used with system 3. Operator effective dose was measured per month using a radiation dosimeter badge. Computed tomography angiography and CBCT were analyzed for findings requiring immediate revision or secondary interventions. End points were patient radiation exposure; operator effective dose; procedure technical success; and 30-day rates of mortality, major adverse events, and secondary interventions. RESULTS: F-BEVAR was performed using system 1 in 98 patients, system 2 in 198 patients, and system 3 in 90 patients. Use of onlay fusion/CBCT was 0% with system 1, 42% with system 2, and 98% with system 3. Procedures performed with onlay fusion/CBCT had significantly (P < .05) higher technical success (99.4% vs 98.8%) and lower contrast material volume (155 ± 58 mL vs 172 ± 80 mL), fluoroscopy time (83 ± 34 minutes vs 94 ± 49 minutes), and cumulative air kerma (2561 ± 1920 mGy vs 3767 ± 2307 mGy). Despite higher case volume and increasing complexity during the experience, operator effective dose decreased to 9 ± 4 × 10-2 mSv/case with system 3 compared with 26 ± 3 × 10-2 mSv/case with system 1 and 20 ± 2 × 10-2 mSv/case with system 2 (P = .001). Among 219 patients who had no CBCT, 18 (8%) had computed tomography angiography findings that prompted secondary interventions before dismissal. Conversely, among 167 patients who had CBCT, 14 patients (8%) had intraoperative CBCT findings requiring immediate revision, with no additional secondary interventions. Patients treated with onlay fusion/CBCT had significantly (P < .05) lower mortality (4% vs 1%), major adverse events (43% vs 19%), and secondary interventions (10% vs 4%) at 30 days. CONCLUSIONS: Radiation exposure and operator effective dose significantly decreased with evolution of F-BEVAR experience and use of advanced imaging applications such as onlay fusion and CBCT. CBCT allowed immediate assessment and identified intraoperative technical problems, leading to immediate revision and avoiding early secondary interventions.

Outcomes of an iliac branch endoprosthesis using an "up-and-over" technique for endovascular repair of failed bifurcated grafts.

OBJECTIVE: Type IB endoleak after endovascular aneurysm repair may be treated by an iliac branch endoprosthesis (IBE) through brachial access for internal iliac artery (IIA) stenting. The aim of this study was to evaluate outcomes of the IBE using an "up-and-over" transfemoral technique in patients with prior aortic repair compared with the standard technique in patients with de novo iliac aneurysms. METHODS: We reviewed the clinical data of patients treated for aortoiliac aneurysms using Gore IBE (W. L. Gore & Associates, Flagstaff, Ariz) between 2014 and 2017. The up-and-over technique was indicated in patients with type IB endoleak or common iliac aneurysms after prior aortic repair with bifurcated endografts or surgical grafts. End points were technical success, mortality, major adverse events, IIA patency, freedom from IIA branch instability (composite end point of any IIA branch-related complication leading to aneurysm rupture, death, occlusion, component separation, or reintervention to maintain branch patency or to treat a branch-related separation or endoleak), and freedom from secondary interventions or new-onset buttock claudication. RESULTS: There were 53 patients (51 male; 74 ± 8 years old) treated by 62 IBEs (9 bilateral). Standard technique was used in 36 patients (43 IBEs) and up-and-over technique in 17 (19 IBEs). Three patients had contralateral IIA embolization. Total procedure time, contrast material volume, and radiation dose averaged 168 ± 98 minutes, 140 ± 50 mL, and 1096 ± 1009 mGy, with no difference between techniques. Technical success was achieved in 98% of patients. Eleven patients had extension of IIA bridging stent into the posterior branch (eight standard, three up-and-over). Four patients (8%) had major adverse events due to estimated blood loss >1000 mL in all patients. There was no 30-day mortality after a median follow-up of 7 months (interquartile range, 3-12 months). There were two IIA stent occlusions (all standard), three iliac-related type I endoleaks (one standard, two up-and-over), and four secondary interventions (three standard, one up-and-over). At 1 year, patients treated by standard or up-and-over technique had similar primary patency (94% ± 4% vs 100%; P = .38) and secondary patency (97% ± 3% vs 100%; P = .54) and freedom from IIA branch instability (90% ± 6% vs 93% ± 7%; P = .48), secondary intervention (84% ± 8% vs 90% ± 9%; P = .63), and new-onset buttock claudication (90% ± 6% vs 100%; P = .35). CONCLUSIONS: Endovascular repair using IBE was associated with high technical success, no mortality, and low rate of complications using either the standard technique for de novo aneurysms or an up-and-over technique for patients with failed bifurcated endografts or grafts. The up-and-over technique should be considered a suitable alternative to brachial access in patients who require distal extension using IBEs.

Evolution from physician-modified to company-manufactured fenestrated-branched endografts to treat pararenal and thoracoabdominal aortic aneurysms.

OBJECTIVE: The purpose of this study was to review treatment trends and outcomes of patients who underwent fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal aneurysms (PRAs) or thoracoabdominal aortic aneurysms (TAAAs) using physician-modified endografts (PMEGs) or company-manufactured devices (CMDs). METHODS: We reviewed the clinical data of 316 consecutive patients (242 male patients; mean age, 75 ± 8 years) who underwent F-BEVAR between 2007 and 2016. F-BEVAR was performed under two prospective investigational device exemption protocols since 2013. End points were mortality, major adverse events (MAEs), patient survival, reintervention, branch instability, aneurysm-related mortality, renal function deterioration, and target vessel patency. RESULTS: There were 145 patients (46%) treated by PMEGs (84 PRAs, 26 extent IV and 35 extent I-III TAAAs) and 171 patients (54%) who had CMDs (88 PRAs, 42 extent IV and 41 extent I-III TAAAs). Choice of endograft evolved from PMEGs in 131 patients (83%) treated in the first half of experience to CMDs in 144 patients (91%) treated in the second half of experience (P < .001). Patients treated by PMEGs had significantly (P < .05) larger aneurysms, more chronic pulmonary and kidney disease, and higher comorbidity severity scores. A total of 1081 renal-mesenteric arteries were targeted in both groups. Technical success was lower for PMEGs (98% vs 99.5%; P = .02). Thirty-day mortality was 5.5% for PMEGs (PRAs, 1.2%; extent IV 3.8% and extent I-III, 17.1%) and 0% for CMDs (P = .0018). Patients treated by PMEGs had significantly more (P < .001) MAEs (48% vs 23%) and longer hospital stay (9 ± 10 days vs 6 ± 6 days; P = .001). Mean follow-up was significantly longer for patients treated by PMEGs (38 ± 26 months vs 14 ± 12 months; P < .001). At 3 years, patient survival (68% ± 4% vs 67% ± 8%; P = .11), freedom from reintervention (68% ± 4% vs 68% ± 8%; P = .17), primary (94% ± 2% vs 92% ± 2%; P = .64) and secondary target vessel patency (98% ± 1% vs 98% ± 1%; P = .89), and freedom from renal function deterioration (75% ± 4% vs 65% ± 6%; P = .24) were similar for patients treated by PMEGs or CMDs, respectively. CONCLUSIONS: Choice of F-BEVAR evolved from PMEGs to almost exclusively CMDs under physician-sponsored investigational device exemption protocols. PMEG patients had more comorbidities and larger aneurysms. CMDs were performed with higher technical success, no mortality, and fewer MAEs.

Severe infolding of fenestrated-branched endovascular stent graft.

Infolding of a fenestrated-branched stent graft is an infrequent complication due to excessive oversizing. We report the case of an 89-year-old man who underwent a four-vessel fenestrated-branched endovascular aortic repair for a pararenal aortic aneurysm. Computed tomography angiography revealed severe infolding across the mesenteric-renal vessels. The patient was treated by angioplasty and placement of Palmaz stent. Cone-beam computed tomography confirmed patent visceral vessels with resolution of the infolding. This case illustrates an uncommon complication that can be prevented by modifications in the stent design and by immediate assessment using intraoperative cone-beam computed tomography.