Mid-Term Outcomes of "Complete Aortic Repair": Surgical or Endovascular Total Arch Replacement With Thoracoabdominal Fenestrated-Branched Endovascular Aortic Repair.

OBJECTIVE: To describe a single-center experience of "complete aortic repair" consisting of surgical or endovascular total arch replacement/repair (TAR) followed by thoracoabdominal fenestrated-branched endovascular aortic repair (FB-EVAR). METHODS: We reviewed 480 consecutive patients who underwent FB-EVAR with physician-modified endografts (PMEGs) or manufactured stent-grafts between 2013 and 2022. From those, we selected only patients treated with open or endovascular arch repair and distal FB-EVAR for aneurysms involving the ascending, arch and thoracoabdominal aortic segments (zones 0-9). Manufactured devices were used under an investigational device exemption protocol. Endpoints included early/in-hospital mortality, mid-term survival, freedom from secondary intervention, and target artery instability. RESULTS: There were 22 patients, 14 men and 8 women with a median age of 72±7 years. Thirteen postdissection and 9 degenerative aortic aneurysms were repaired with a mean maximum diameter of 67±11 mm. Time from index aortic procedure to aneurysm exclusion was 169 and 270 days in those undergoing 2- and 3-stage repair strategies, respectively. The ascending aorta and aortic arch were treated with 19 surgical and 3 endovascular TAR procedures. Three (16%) surgical arch procedures were performed elsewhere, and perioperative details were unavailable. Mean bypass, cross-clamp, and circulatory arrest times were 295±57, 216±63, and 46±11 minutes, respectively. There were 4 major adverse events (MAEs) in 2 patients: both required postoperative hemodialysis, 1 had postbypass cardiogenic shock necessitating extracorporeal membrane oxygenation, and the other required evacuation of an acute-on-chronic subdural hematoma. Thoracoabdominal aortic aneurysm repair was performed with 17 manufactured endografts and 5 PMEGs. There was no early mortality. Six (27%) patients experienced MAEs. There were 4 (18%) cases of spinal cord injury with 3 (75%) experiencing complete symptom resolution before discharge. Mean follow-up was 30±17 months in which there were 5 patient deaths-0 aortic related. Eight patients required ≥1 secondary intervention, and 6 target arteries demonstrated instability (3 IC, 1 IIIC endoleaks; 2 TA stenoses). Kaplan-Meier 3-year estimates of patient survival, freedom from secondary intervention, and target artery instability were 78±8%, 56±11%, and 68±11%, respectively. CONCLUSION: Complete aortic repair with staged surgical or endovascular TAR and distal FB-EVAR is safe and effective with satisfactory morbidity, mid-term survival, and target artery outcomes. CLINICAL IMPACT: The presented study demonstrates that repair of the entirety of the aorta - via total endovascular or hybrid means- is safe and effective with low rates of spinal cord ischemia. Cardiovascular specialists within comprehensive aortic teams at should feel confident that staged repair of the most complex degenerative and post-dissection thoracoabdominal aortic aneurysms can be safely performed in their patients with complication profile similar to that of less extensive repairs. Meticulous and intentional case planning is imperative for immediate and long-term success.

Characterization of Secondary Interventions After Fenestrated-branched Endovascular Repair of Complex Aortic Aneurysms and Its Effect on Quality of Life and Patient Survival.

OBJECTIVE: To assess the impact of secondary intervention (SI) on health-related quality of life (HR-QOL) after fenestrated-branched endovascular aortic repair (FB-EVAR) for complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. BACKGROUND: The effect of SI after FB-EVAR on physical and mental HR-QOL has not been described. METHODS: A cohort of 430 consecutive patients enrolled in a prospective, nonrandomized study to evaluate FB-EVAR (2013-2020) was assessed with 1325 short-form 36 HR-QOL questionnaires preoperatively and during follow-up visits. SIs were classified as major or minor procedures. Endpoints included patient survival, freedom from aortic-related mortality (ARM), freedom from SIs, and changes in HR-QOL physical component score (PCS) and mental component score. RESULTS: There were 302 male with mean age 74±8 years treated by FB-EVAR for 133 complex abdominal aortic aneurysms and 297 thoracoabdominal aortic aneurysms. After a mean follow up of 26±20 months, 97 patients (23%) required 137 SIs. At 5 years, freedom from any SI was 64%±4%, including freedom from minor SIs of 77%±4% and major SIs of 87%±3%. There was no difference in patient survival and freedom from ARM at same interval. On adjusted analysis, minor SIs correlated with improved survival. SIs had a negative correlation with PCS ( r =-0.8). There were no significant changes in mental component score with SIs. Predictors for SIs were fluoroscopy time, graft design, and aneurysm sac change. CONCLUSION: SIs were needed in nearly 1 out of 4 patients treated by FB-EVAR with no effect on patient survival or ARM. SI resulted in decline in PCS.

Safety of Percutaneous Femoral Access for Endovascular Aortic Aneurysm Repair Through Previously Surgically Exposed or Repaired Femoral Arteries.

OBJECTIVE: Percutaneous femoral artery access is being increasingly used in endovascular aortic repair (EVAR). The technique can be challenging in patients with previously surgically exposed or repaired femoral arteries because of excessive scar tissue. However, a successful percutaneous approach may cause less morbidity than a "re-do" open femoral approach. The aim of this study was to assess the impact of prior open surgical femoral exposure on technical success and clinical outcomes of percutaneous approach. METHODS: This study retrospectively reviewed the clinical data of patients who underwent percutaneous EVAR between 2010 and 2020 at 2 major aortic centers. Patients were divided into 2 groups (with or without prior open surgical femoral access) for analysis of clinical outcomes. Only punctures with sheaths ≥12Fr were included for analysis. The access and (pre)closure techniques were similar in both institutions. Primary end points were intraoperative technical success, access-related revision, and access complications. A multivariate analysis was performed to identify determinants of conversion to open approach and femoral access complications in intact and re-do groins. RESULTS: A total of 632 patients underwent percutaneous (complex) EVAR: 98 had prior open surgical femoral access and 534 patients underwent de novo femoral percutaneous access. A total of 1099 femoral artery punctures were performed: 149 in re-do and 950 in intact groins. The extent of endovascular repair included 159 infrarenal, 82 thoracic, 368 fenestrated/branched, and 23 iliac branch devices. No significant differences were seen in technical success (re-do 93.3% vs intact 95.3%, p=0.311), access-related surgical revision (0.7% vs 0.6%, p=0.950), and access complications (2.7% vs 4.0%, p=0.443). For the whole group, significant predictors for access complications in multivariate analyses were main access site (odds ratio [OR] 2.39; 95% confidence interval [CI] 1.07%-5.35%; p=0.033) and increase of the procedure time per hour (OR 1.65; 95% CI 1.34%-2.04%; p<0.001), while increase in sheath-vessel ratio had a protective effect (OR 0.33; 95% CI 0.127%-0.85%; p=0.021). Surgical conversion was predicted by main access site (OR 2.32; 95% CI 1.28%-4.19%; p=0.007) and calcification of 50% to 75% of the circumference of the access vessel (OR 3.29; 95% CI 1.38%-7.86%; p=0.005). CONCLUSION: Within our population prior open surgical femoral artery exposure or repair had no negative impact on the technical success and clinical outcomes of percutaneous (complex) endovascular aortic aneurysm repair.

Multicenter Study to Evaluate Endovascular Repair of Extent I-III Thoracoabdominal Aneurysms Without Prophylactic Cerebrospinal Fluid Drainage.

OBJECTIVE: To assess outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) of Extent I-III thoracoabdominal aortic aneurysms (TAAAs) without prophylactic cerebrospinal fluid drainage (CSFD). BACKGROUND: Prophylactic CSFD has been routinely used during endovascular TAAA repair, but concerns about major drain-related complications have led to revising this paradigm. METHODS: We reviewed a multicenter cohort of 541 patients treated for Extent I-III TAAAs by FB-EVAR without prophylactic CSFD. Spinal cord injury (SCI) was graded as ambulatory (paraparesis) or nonambulatory (paraplegia). Endpoints were any SCI, permanent paraplegia, response to rescue treatment, major drain-related complications, mortality, and patient survival. RESULTS: There were 22 Extent I, 240 Extent II and 279 Extent III TAAAs. Thirty-day mortality was 3%. SCI occurred in 45 patients (8%), paraparesis occurring in 23 (4%) and paraplegia in 22 patients (4%). SCI was more common in patients with Extent I-II compared with Extent III TAAAs (12% vs. 5%, P =0.01). Rescue treatment included permissive hypertension in all patients, with CSFD in 22 (4%). Symptom improvement was noted in 73%. Twelve patients (2%) had permanent paraplegia. Two patients (0.4%) had major drain-related complications. Independent predictors for SCI by multivariate logistic regression were sustained perioperative hypotension [odds ratio (OR): 4.4, 95% confidence interval (95% CI): 1.7-11.1], patent collateral network (OR: 0.3, 95% CI: 0.1-0.6), and total length of aortic coverage (OR: 1.05, 95% CI: 1.01-1.10). Patient survival at 3 years was 72%±3%. CONCLUSION: FB-EVAR of Extent I-III TAAAs without CSFD has low mortality and low rates of permanent paraplegia (2%). SCI occurred in 8% of patients, and rescue treatment improved symptoms in 73% of them.

Outcomes of "Anterior Versus Posterior Divisional Branches of the Hypogastric Artery as Distal Landing Zone for Iliac Branch Devices": The International Multicentric R3OYAL Registry.

OBJECTIVE: The aim of this multicentric registry was to assess the outcomes of "anteRior versus posteRior divisional bRanches Of the hYpogastric artery as distAl landing zone for iLiac branch devices (R3OYAL)." METHODS: The main exposure of interest for the purpose of this study was the internal iliac artery (IIA) divisional branch (anterior vs posterior) that was used as distal landing zone. Early endpoints included technical success and adverse events. Late endpoints included survival, primary/secondary IIA patency, and IIA branch instability. RESULTS: A total of 171 patients were included in the study, of which 50 received bilateral implantation of iliac branch devices (IBDs). This resulted in a total of 221 incorporated IIAs included in the final analysis, of which 40 were anterior divisional branches and 181 were posterior divisional branches. Technical success was high in both groups (anterior division: 98% vs posterior division: 100%, P = .18). Occurrence of any adverse event was noted in 14% of patients in both groups (P = 1.0). The overall rate of freedom from the composite IBD branch instability did not show significant differences between patients receiving distal landing in the anterior or posterior division of the IIA at 3 years (79% vs 87%, log-rank test = .215). The 3-year estimates of IBD patency were significantly lower in patients who received distal landing in the anterior divisional branch than those who received distal landing in the posterior divisional branch (primary patency: 81% vs 96%, log-rank test = .009; secondary patency: 81% vs 97%, log-rank test < .001). CONCLUSIONS: The use of the anterior or posterior divisional branches of the IIA as distal landing zone for IBD implantation shows comparable profiles in terms of immediate technical success, perioperative safety, and side-branch instability up to 3 years. However, IBD patency at 3 years was higher when the distal landing zone was achieved within the posterior divisional branch of the IIA. CLINICAL IMPACT: The results from this large multicentric registry confirm that use of the anterior or posterior divisional branches of the internal iliac artery (IIA) as distal landing zone for implantation of iliac branch devices (IBD) shows comparable profiles of safety and feasibility, thereby allowing to extend the indications for endovascular repair of aorto-iliac aneurysms to cases with unsuitable anatomy within the IIA main trunk. Although mid-term rates of device durability and branch instability seem to be similar, the rates of primary and secondary IBD patency at three years was favored when the distal landing zone was achieved in the posterior divisional branch of the IIA.

Endovascular Repair of Complex Aortic Aneurysms.

Fenestrated-branched endovascular aortic repair (FB-EVAR) has gained widespread acceptance in patients with complex aortic aneurysms. It has evolved from an alternative to treat elderly and higher risk patients to the first line of treatment in most patients with suitable anatomy, independent of the clinical risk. Currently, these devices are available off-the-shelf (ready to use) and tailored to the patient anatomy with the options of fenestrated, branched and mixed fenestrated, and branched designs. Reports from single and multicenter experiences and systematic reviews have shown lower mortality and morbidity for FB-EVAR compared with historical results of open surgical repair. The main advantages are noted on mortality, respiratory complications, acute kidney injury, and length of hospital stay. The purpose of this article is to review the advances in the endovascular repair of complex aortic aneurysms exploring the indications for treatment, preoperative evaluation, patient selection, device design, and implantation technique.

Outcomes of off-the-shelf multibranched stent grafts with intentional occlusion of directional branches using endovascular plugs during endovascular repair of complex aortic aneurysms.

OBJECTIVE: To evaluate the technique and outcomes of intentional occlusion of directional branches (DBs) using endovascular plugs during branched endovascular aortic repair using off-the-shelf Zenith t-Branch thoracoabdominal (TAAA) stent grafts. METHODS: We reviewed the clinical data and outcomes of all consecutive patients treated by branched endovascular aortic repair using off-the-shelf Zenith t-Branch TAAA stent-graft (Cook Medical, Bloomington, Ind) in seven academic centers from 2013 to 2019. All patients had at least one DB intentionally occluded using extension of the branch with balloon or self-expandable covered stent, followed by placement of endovascular plugs. Intentional occlusion was indicated in patients with variations in the normal four-vessel renal-mesenteric anatomy, pre-existing dialysis, or in those who failed catheterization of a target vessel. End points were 30-day/in-hospital mortality, major adverse events, secondary interventions, target artery (TA) patency, TA instability, and patient survival. RESULTS: There were 100 patients, 65 male and 35 female, with median age of 71 years (interquartile range [IQR], 66-75 years). Of these, 31 patients (31%) had urgent/emergent operations for symptomatic/contained ruptured aneurysms. The median aneurysm diameter was 72 mm (IQR, 61-85 mm). A total of 290 renal-mesenteric arteries were incorporated with a median of three (IQR, 3-3) vessels/patient. Indications for DB occlusion were less than four suitable renal-mesenteric targets in 84 patients or pre-existing dialysis and inability to catheterize a target vessel in eight patients each. There were 110 DBs occluded by vascular plugs, including 48 celiac axis, one superior mesenteric artery, and 61 renal DBs. Thirty-day/in-hospital mortality was 10%, including 9% for elective and 13% for urgent/emergent procedures. Major adverse events occurred in 44 patients (44%), including acute kidney injury in 19 patients (19%), estimated blood loss >1 L in 12 patients (12%), respiratory failure and new onset dialysis in six patients (6%) each, bowel ischemia in five patients (5%), and myocardial infarction and paraplegia in two patients (2%) each. The median follow-up was 5 months (range, 1-13 months). Eighteen patients (18%) required secondary interventions, none for problems related to the occluded DB. There were no endoleaks related to the occluded DB. At 2 years, primary and secondary patency and freedom from TA instability were 93% ± 3%, 97% ± 2%, and 91% ± 4%, respectively. Freedom from secondary interventions and patient survival were 75% ± 6% and 63% ± 7%, respectively. CONCLUSIONS: Intentional occlusion of DBs using endovascular plugs allows versatile use of a four-vessel off-the-shelf multi-branched TAAA stent graft in patients with variations in the normal renal and mesenteric anatomy or when technical difficulties prevent successful target vessel stenting. There were no endoleaks or secondary interventions associated with the occluded DB.

Incidence, predictive factors, and outcomes of intraprocedure adverse events during fenestrated-branched endovascular aortic repair of complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: To evaluate the incidence of intraoperative adverse events (IAEs) and their impact on outcomes after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysm (TAAAs). METHODS: We reviewed the clinical and imaging data of 600 consecutive patients (445 males; mean age, 75 ± 8 years) who underwent FB-EVAR between 2007 and 2019 in a single institution. IAE was defined as any intraoperative complication or technical problem requiring additional and unplanned procedures, and was classified as access-related, target artery (TA)-related, or graft-related. End points included rates of IAEs, 30-day or in-hospital mortality, major adverse events, patient survival, freedom from secondary intervention, and TA instability. RESULTS: A total of 122 IAEs were identified in 105 patients (18%). IAEs were TA-related in 55 patients (9%), access-related in 46 patients (8%), and graft-related in seven patients (1%). Female sex was more frequent among patients with IAEs (44% vs 22%; P < .001). Patients with IAEs had smaller renal artery diameter (-0.4 mm, 5.4 ± 0.8 mm vs 5.8 ± 0.9 mm; P < .001), and were treated more often for TAAAs (72% vs 54%; P < .03). Technical success was achieved in 96.5% of patients and was lower for patients with IAEs (82% vs 99%; P < .001). Major adverse events were significantly more frequent among patients who had IAEs (odds ratio [OR], 1.98; 95% confidence interval [CI], 1.21-3.25), most due to acute kidney injury (27% vs 11%; P < .001) including new-onset dialysis (5% vs 1%; P = .01). On multivariate logistic regression model, female sex (OR, 2.5; 95% CI, 1.5-4.0), TA stenosis >50% (OR, 2.0; 95% CI, 1.3-3.3), and Crawford Extent II TAAA (OR, 1.9; 95% CI, 1.1-3.3) were predictive of IAEs, whereas preloaded design (OR, 0.6; 95% CI, 0.4-0.9) and TA diameter (+1 mm; OR, 0.6; 95% CI, 0.4-0.9) were protective of IAEs. IAEs negatively affected secondary intervention (hazard ratio [HR], 1.6; 95% CI, 1.1-2.3) and TA instability (HR, 2.5; 95% CI, 1.2-5.4); however, IAEs did not affect patient survival (HR, 1.0; 95% CI, 0.7-1.4). CONCLUSIONS: IAEs are common, occurring in nearly one of five patients treated with FB-EVAR for complex aortic aneurysms, and have a negative impact on clinical outcomes. IAEs were associated with female sex, TA diameter, and more extensive aortic disease.

Comparison of Cerebral Embolic Events Between Right and Left Upper Extremity Access During Fenestrated/Branched Endovascular Aortic Repair.

PURPOSE: To evaluate the incidence and outcomes of cerebral embolic events when using right (RUE) vs left upper extremity (LUE) access for fenestrated/branched endovascular aneurysm repair (f/bEVAR). MATERIALS AND METHODS: A retrospective review was conducted of 290 consecutive patients enrolled in a physician-sponsored Investigational Device Exemption study to evaluate f/bEVAR between 2013 and 2018. Of these, 270 patients (93%) had an upper extremity access with 12-F sheaths, including 205 patients (mean age 75±8 years; 147 men) with LUE and 65 patients (mean age 73±8 years; 42 men) with RUE access. Outcome measures were technical success, procedural metrics, major adverse events (MAEs), any stroke or transient ischemic attack (TIA), and mortality. RESULTS: Technical success was higher (p=0.04) for LUE (99.6%) vs RUE access (98.4%). Patients treated via RUE access more often had extent I-III thoracoabdominal aortic aneurysms (57% vs 39%, p=0.03). Procedural metrics were similar for LUE vs RUE sides, including endovascular time (255±80 vs 246±83 minutes, respectively; p=0.23), fluoroscopy time (84±32 vs 90±35 minutes, respectively; p=0.80), and contrast volume (156±57 vs 153±56 mL, respectively; p=0.82). Total radiation exposure was significantly higher for LUE vs RUE access (2463±1912 vs 1757±1494 mGy, respectively; p=0.02). There were 2 deaths (1%) at 30 days or during hospital admission, both unrelated to access site complications. MAEs occurred in 32% of patients who had LUE and 26% of those who had RUE access (p=0.44). Five patients (2%) had embolic stroke and none had TIA. Embolic strokes were ipsilateral to the access side in 4 patients and affected the posterior circulation in 3. Two patients (1%) had hemorrhagic strokes. The incidence of stroke was 3% for LUE and 2% for RUE access (p>0.99). CONCLUSION: Fenestrated/branched stent-graft repair was associated with low rates of cerebral embolic events and no significant difference between the right vs left upper extremity approach.

Effect of obesity on radiation exposure, quality of life scores, and outcomes of fenestrated-branched endovascular aortic repair of pararenal and thoracoabdominal aortic aneurysms.

BACKGROUND: The aim of the present study was to assess the effect of obesity on procedural metrics, radiation exposure, quality of life (QOL), and clinical outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) of pararenal and thoracoabdominal aortic aneurysms. METHODS: We reviewed the clinical data from 334 patients (236 men; mean age, 75 ± 8 years) enrolled in a prospective nonrandomized study to evaluate FB-EVAR from 2013 to 2019. The patients were classified using the body mass index (BMI) as obese (BMI ≥30 kg/m2) or nonobese (BMI <30 kg/m2). QOL questionnaires (short-form 36-item questionnaire) and imaging studies were obtained preoperatively and at 2 months and 6 months postoperatively, and annually thereafter. The procedures were performed using two different fixed imaging systems. The end points included procedural metrics (ie, total operative time, fluoroscopic time, contrast volume), radiation exposure, technical success, 30-day mortality, and major adverse events, QOL changes, freedom from target vessel instability, freedom from reintervention, and patient survival. RESULTS: The aneurysm extent was a pararenal aortic aneurysm in 117 patients (35%) and a thoracoabdominal aortic aneurysm in 217 patients (65%). Both groups had similar demographics, cardiovascular risk factors, and aneurysm extent, except for a greater incidence of hyperlipidemia and diabetes among the obese patients (P < .05). No significant differences were found in the procedural metrics or intraprocedural complications between the groups, except that the obese patients had greater radiation exposure than the nonobese patients (mean, 2.5 vs 1.6 Gy; P < .001), with the highest radiation exposure in those obese patients who had undergone the procedure using system 1 (fusion alone) instead of system 2 (fusion and digital zoom; mean, 4.1 vs 1.5 Gy; P < .001). Three patients had died within 30 days (0.8%), with no difference in mortality or major adverse events between the groups. The mental QOL scores had improved in the obese group at 2 and 12 months compared with the nonobese patients, with persistently higher scores up to 3 years. At 3 years, the obese and nonobese patients had a similar incidence of freedom from target vessel instability (74% ± 6% vs 80% ± 3%; P = .99, log-rank test), freedom from reintervention (66% ± 6% vs 73% ± 4%; P = .77, log-rank test), and patient survival (83% ± 5% vs 75% ± 4%; P = .16, log-rank test). CONCLUSIONS: FB-EVAR was performed with high technical success and low mortality and morbidity, with no significant differences between the obese and nonobese patients. The procedural metrics and outcomes were similar, with the exception of greater radiation exposure among obese patients, especially for the procedures performed using system 1 with fusion alone compared with system 2 (fusion and digital zoom). Obese patients had higher QOL mental scores at 2 and 12 months, with a similar reintervention rate, target vessel outcomes, and survival compared with nonobese patients.

Impact of intentional accessory renal artery coverage on renal outcomes after fenestrated-branched endovascular aortic repair.

OBJECTIVE: The objective of this study was to evaluate the impact of intentional coverage of accessory renal arteries (ARAs) on renal outcomes after fenestrated-branched endovascular aortic repair (FB-EVAR) for pararenal aortic aneurysms or thoracoabdominal aortic aneurysms. METHODS: We analyzed the clinical data of 296 patients enrolled in a prospective nonrandomized study to evaluate outcomes of FB-EVAR between 2013 and 2018. Patients with solitary kidneys, intraoperative loss of main renal arteries, or pre-existing stage V chronic kidney disease were excluded. Two groups were analyzed: patients with intentional ARA coverage; and controls, who had complete preservation. End points included 30-day mortality; major adverse events; acute kidney injury (AKI), defined by RIFLE criteria (Risk, Injury, Failure, Loss of kidney function, and End-stage renal disease); renal function deterioration (RFD), defined by >30% decline in baseline estimated glomerular filtration rate; and presence of renal infarcts. RESULTS: There were 254 patients (184 male; mean age, 75 ± 8 years) included in the study, 56 (22%) with intentional ARA coverage and 198 controls, of whom 16 had ARA preservation. ARA diameter was smaller in patients who had intentional coverage vs preservation (2.7 ± 0.9 mm vs 3.4 ± 0.2 mm; P < .001). There was no difference in demographics, cardiovascular risk factors, and aneurysm extent. All ARAs intended to be incorporated were successfully stented. Patients with ARA coverage had a higher frequency of kidney infarction (75% vs 25%; P < .001). There were two (1%) deaths within 30 days, both among controls. Patients with ARA coverage had more major adverse events (32% vs 19%; P = .04) because of higher incidence of AKI (21% vs 9%; P = .02). None of the 16 patients who had ARA preservation developed AKI. At 3 years, freedom from RFD was lower for patients who had ARA coverage compared with controls (55% ± 9% vs 76% ± 5%; log-rank, P = .02). By multivariate analysis, predictors of AKI were ARA coverage (odds ratio, 2.8; 95% confidence interval [CI], 1.2-6.2; P = .01) and estimated blood loss >1 L (odds ratio, 3.8; 95% CI, 1.2-12.3; P = .03). Postoperative AKI (hazard ratio [HR], 4.4; 95% CI, 2.4-8.1; P < .001), renal reintervention for stenosis (HR, 3.2; 95% CI, 1.6-6.7; P = .002), aneurysm diameter (HR, 1.04; 95% CI, 1.02-1.06; P < .001), and ARA coverage (HR, 2.0; 95% CI, 2.4-8.1; P = .02) were predictors of RFD. CONCLUSIONS: Intentional ARA coverage during FB-EVAR was associated with a threefold increase in AKI and with lower freedom from RFD. Factors associated with RFD included postoperative AKI, renal reinterventions for stenosis, and ARA coverage. Incorporation of ARAs during FB-EVAR, when it is technically feasible, helps decrease risk of AKI and RFD.

Staged total arch replacement, followed by fenestrated-branched endovascular aortic repair, for patients with mega aortic syndrome.

OBJECTIVE: The aim of the present study was to review the clinical outcomes of a staged approach using total arch replacement (TAR) with an elephant trunk or a frozen elephant trunk, followed by fenestrated-branched endovascular aortic repair (F-BEVAR) for patients with mega aortic syndrome. METHODS: We reviewed the clinical data and outcomes of 11 consecutive patients (8 men; mean age, 71 ± 7 years) treated by staged TAR and F-BEVAR from January 2014 to December 2018. The F-BEVAR procedures were performed under a prospective, nonrandomized, physician-sponsored investigational device exemption protocol. All patients had had mega aortic syndrome, defined by an ascending aorta, arch, and extent I-II thoracoabdominal aortic aneurysm. The endpoints were 30-day mortality, major adverse events (MAE), patient survival, freedom from reintervention, and freedom from target vessel instability. RESULTS: Of the 11 patients, 6 had developed chronic postdissection aneurysms after previous Stanford A (three A11, two A10, one A9) dissection repair and 5 had had degenerative aneurysms with no suitable landing zone in the aortic arch. The thoracoabdominal aortic aneurysms were classified as extent I in four patients and extent II in seven. One patient had died within 30 days after TAR (9.0%). However, none of the remaining 10 patients who had undergone F-BEVAR had died. First-stage TAR resulted in MAE in three patients (27%), including one spinal cord injury. The mean length of stay was 12 ± 6 days. The mean interval between TAR and F-BEVAR was 245 ± 138 days with no aneurysm rupture during the interval. Second-stage F-BEVAR was associated with MAE in two patients (20%), including spinal cord injury in one patient from spinal hematoma due to placement of a cerebrospinal fluid drain. The mean follow-up period was 14 ± 10 months. At 2 years postoperatively, patient survival, primary patency, secondary patency, and freedom from renal-mesenteric target vessel instability was 80% ± 9%, 94% ± 6%, 100%, and 86% ± 8%, respectively. No aortic-related deaths occurred during the follow-up period. Four patients had required reintervention, all performed using an endovascular approach. CONCLUSIONS: A staged approach to treatment of mega aortic syndrome using TAR and F-BEVAR is a feasible alternative for selected high-risk patients. Larger clinical experience and longer follow-up are needed.

Endovascular Arch Repair Using Inner Branch Stent-Graft With Transapical Access.

Endovascular repair of aortic arch aneurysms has been considered in higher risk patients who are not ideally suited for open surgical or hybrid repair. A limitation of these devices is the 8- to 12-week delay for manufacturing, which does not allow treatment of symptomatic or rapidly expanding aneurysms. This report illustrates an urgent endovascular repair of an aortic arch aneurysm using a physician-modified endograft with 2 inner branches. Transapical access allowed better support and precision during device deployment, which was needed given the short proximal landing zone.