Urgent endovascular repair of juxtarenal/pararenal aneurysm by off-the-shelf multibranched endograft.

OBJECTIVE: To report outcomes of urgent juxtarenal/pararenal aneurysms (J/P-AAAs) managed by off-the-shelf multibranched thoracoabdominal endografts (Cook, T-branch). METHODS: In this observational, multicenter, retrospective study, patients with J/P-AAAs treated by urgent endovascular repair by T-branch in 23 European aortic centers, from 2013 to 2023, were analyzed. Contained J/P-AAAs rupture, presence of related symptoms, and aneurysm diameter of >70 mm were considered as indication for urgent repair. Technical success (TS), spinal cord ischemia (SCI), and 30-day/hospital mortality were assessed as early outcomes. Survival, freedom from reinterventions, and target artery instability (TAI) were evaluated during follow-up. RESULTS: Overall, 197 patients (J-AAAs, n = 64 [33%]; P-AAAs, n = 95 [48%]; previous failed endovascular aneurysm repair (EVAR), n = 38 [19%]) were analyzed. The mean age and aneurysm diameter was 75 ± 8 years and 76 ± 4 mm, respectively. The American Society of Anesthesiologists score was 3 and 4 in 118 (60%) and 79 (40%) patients. Rupture, symptoms, and diameter of >70 mm were present in 51 (26%), 110 (56%), and 53 (27%) patients, respectively. An adjunctive proximal thoracic endograft was used in 28 cases (14%). The mean aortic coverage between the upper portion of the endograft and the lowest renal artery was 154 ± 49 mm. Single-stage repair and cerebrospinal fluid drainage were reported in 144 (73%) and 53 (27%) cases, respectively. TS was achieved in 182 (92%) cases (rupture, 84% vs no rupture, 95%; P = .02). Failures consist of TA loss (11 [6%]: renal artery, 9; celiac trunk, 2), type I to III endoleaks (2 [1%]), and 24-h mortality (2 [1%]). Rupture was a risk factor for technical failure (P = .02; odds ratio [OR], 3.8; 95% confidence interval [CI], 1.1-12.1). Overall, 15 patients (8%) had persistent SCI (rupture, 14% vs no rupture, 5%) with 11 (6%) , of paraplegia (rupture, 10% vs no rupture, 5%; P = .001). Rupture (P = .04; OR, 3.1; 95% CI, 1.1-8.9) and adjunctive proximal thoracic endograft (P = .01; OR, 4.1; 95% CI, 1.3-12.9) were risk-factors for SCI. Twenty-two patients (11%) died within 30 days or during a prolonged hospitalization. Previous failed EVAR (P = .04; OR, 3.6; 95% CI, 1.1-12.3), paraplegia (P < .001; OR, 9.9; 95% CI, 1.6-62.2) and postoperative mesenteric complications (P = .03; OR, 10.4; 95% CI, 1.2-93.3), as well as cardiac (P = .03; OR, 8.2; 95% CI, 2.0-33.0) and respiratory (P < .001; OR, 10.1; 95% CI, 2.9-35.2) morbidities were associated with 30-day/hospital mortality. The mean follow-up was 19 ± 5 months. The estimated 3-year survival and freedom from reinterventions was 58% and 77%, respectively. TAI occurred in 27 patients (14%) (occlusion, 15; endoleak, 14) with an estimated 3-year freedom from TAI of 72%. CONCLUSIONS: Urgent repair of J/P-AAAs by T-branch is feasible and effective with satisfactory TS and 30-day/hospital mortality in high-risk patients. However, extensive aortic coverage is necessary, leading to a non-negligible SCI rate, especially in case of aortic rupture or when adjunctive thoracic endografts are necessary. Previous failed EVAR and postoperative mesenteric complications, as well as cardiac and respiratory morbidities were associated with 30-day/hospital mortality and should be subjected to more research for the purposes of improving outcomes.

Pararenal Aortic Thrombus in Patients Undergoing Aortic Aneurysm Repair With Chimney Technique.

INTRODUCTION: Chimney technique (chimney graft in abdominal aortic aneurysm repair [ChEVAR]) can be used to treat patients with pararenal aortic aneurysm unfit for open surgery and not suitable for custom-made fenestrated endograft. Since almost 1 in 5 patients undergo a reintervention within 3 years, features associated with higher risk of complications need to be investigated to tailor the follow-up schedule to each patient. The aim of our study was to assess the impact of mural thrombus in the pararenal aorta on perioperative and follow-up complications after ChEVAR. METHODS: All consecutive patients undergoing ChEVAR at our center from 2015 to 2022 were included in this retrospective study. Collected variables included number of target vessels, stent graft size, presence, and severity of mural thrombus in pararenal aorta, which was reported with a scoring system from 0 to 10 based on thrombus type, thickness area, and circumferenceAnalyzed outcomes included perioperative and follow-up complications. RESULTS: Thirty-one patients underwent ChEVAR during the study period. In 4 patients the indication for ChEVAR was type 1A endoleak after a previous endovascular aneurysm repair (EVAR). The number of target vessels was 1 in 17 patients (55%), 2 in 12 (39%), 3 in 1 (3%), and 4 in 1 (%). The mean mural thrombus score was 5.9. Complications were the following: type 1A endoleak in 4 cases (13%), chimney stent complications in 7 cases (23%) (including partial or total thrombosis, intrastent stenosis, displacement), renal function worsening during follow-up in 8 cases (26%). Overall survival was 90% at 2 years. Patients with severe mural thrombus showed lower freedom from ChEVAR-related complications (28% vs 59% at 2 years, p=0.023). CONCLUSIONS: The presence of severe pararenal aortic mural thrombus was associated with lower freedom from ChEVAR-related complications in patients undergoing ChEVAR for pararenal aortic aneurysm repair. Further research with a larger number of patients is required to confirm these results. CLINICAL IMPACT: The analysis of severity of mural thrombus in pararenal aorta, which was reported with a scoring system from 0 to 10 based on thrombus type, thickness area and circumference, can be useful and can be represent an important predictor element for complications in patient submitted to Chimney tecnique; in fact the presence of severe pararenal aortic mural thrombus was associated with lower freedom from ChEVAR-related complications in patients undergoing ChEVAR for pararenal aortic aneurysm repair. Then, in patient with pararenal aortic aneurysm, a preoperative evaluation could be focused on severity of mural thrombus to minimize the complications in ChEVAR tecnique or to change the surgical strategy.

Fenestrated Endovascular Aortic Repair After Failed Endovascular Aortic Repair.

PURPOSE: Fenestrated endovascular aortic repair (FEVAR) is technically more challenging when performed after a failing EVAR procedure (FEVAR after EVAR). This study aims to assess the technical outcome of FEVAR after EVAR and to identify factors that may influence complication rates. METHODS: A retrospective observational study was conducted at a single department of vascular and endovascular surgery. The rate of FEVAR after EVAR compared to primary FEVAR is reported. Complication and primary unconnected fenestration (PUF) rates as well as survival were assessed for the FEVAR after EVAR cohort. PUF rates and operating time were also compared to all primary FEVAR patients. Patient characteristics and technical factors such as number of fenestrations or use of a steerable sheath were assessed as possible influencers on technical success when performing FEVAR after EVAR. RESULTS: Two hundred and nine fenestrated devices were implanted during the study period (2013 to April 2020). Thirty-five patients (16.7% of all FEVAR patients) had undergone FEVAR after EVAR and were included in the study. Overall survival at last follow-up (20.2±19.1 months) was 82.9% in FEVAR after EVAR patients. Rates of technical failure dropped significantly after 14 procedures (42.9% vs. 9.5%; p=0.03). Primary unconnected fenestrations were seen in 3 cases of FEVAR after EVAR (8.6%) and 14 of 174 primary FEVAR cases (8.0%; p>0.99). Operating time for FEVAR after EVAR was significantly higher than for primary FEVAR (301.1±110.5 minutes vs. 253.9±103.4 minutes; p=0.02). The availability of a steerable sheath was a significant predictor of reduced risk of PUFs, whereas age and gender, number of fenestrations or suprarenal fixation of the failed EVAR did not significantly influence PUF rates. CONCLUSION: Fewer technical complications were seen over the study period in FEVAR after EVAR patients. While rates of PUFs were not different from primary FEVAR, operating time was significantly longer in patients undergoing FEVAR for failed EVAR. Fenestrated EVAR can be a valuable and safe tool to treat patients with progression of aortic disease or type Ia endoleak after EVAR but may be more complex to achieve than primary FEVAR. CLINICAL IMPACT: This retrospective study assesses the technical outcome of fenestrated endovascular aortic repair (fenestrated EVAR; FEVAR) after prior EVAR. While rates of primary unconnected fenestrations were not different from primary FEVAR, operating time was significantly longer in patients undergoing FEVAR for failed EVAR. Fenestrated EVAR after prior EVAR may be technically more challenging than primary FEVAR procedures, but could be performed with equally good results in this patient cohort. FEVAR offers a feasible treatment option for patients with progression of aortic disease or type Ia endoleak after EVAR.

Physician Modification of a Custom-Made Fenestrated Endograft By Closure of a Fenestration With Bovine Patch.

PURPOSE: Ruptured mycotic pararenal aortic aneurysms are rare and serious condition that requires prompt treatment. Open surgery with aortic resection and in-situ or extra-anatomic reconstruction is the standard treatment. The aim of this technical note is to report urgent endovascular treatment using a readily available custom-made device (created for another patient), with a back-table modification using pericardium patch and a new fenestration. TECHNIQUE: In preoperative measurements on centerline-based workstation, aortic diameter in proximal and distal landing zone and target vessel position matched the measurements of graft plan of custom-made device (CMD) besides left renal artery. To address current patient`s anatomy, closure of the nonsuitable fenestration with pericardial patch and creation of new fenestration (1 cm above and 1:15 hours posterior to original fenestration) for the respective target vessel have been performed. Postoperative computed tomography angiography (CTA) scan showed complete exclusion of aneurysm, perfused target vessels, and no endoleak. Under resistance-based antibiotic therapy, the patient was asymptomatic and showed normal infection parameters in blood samples postoperatively. CONCLUSION: In the hands of an experienced endovascular aortic surgeon modification of a custom-made device is a quick and feasible technique in this emergency situation. Long-term follow-up must confirm the durability and reliability of this new technique. CLINICAL IMPACT: The described technique of modification of a custom-made endograft can provide an alternative endovascular treatment option for urgent complex abdominal aortic pathologies. Compared to the current available treatment modalities, like physician modified endografts, off-the-shelf branched devices, parallel grafts and in-situ fenestration, it can save considerable time and provides reasonable sealing in ruptured cases. The technique offers a valuable add-on to the armamentarium of experienced endovascular physicians.

Urgent Juxtarenal Aortic Aneurysm Repair With Modified Off-the-shelf Endograft to Preserve Intercostal Arteries and Branch Incorporation by Transfemoral Access.

PURPOSE: To demonstrate the feasibility of the modification to preserve intercostal arteries of the t-Branch Endograft (Cook Medical, Bloomington, IN) in an urgent setting, associated with a less invasive approach for branch incorporation from percutaneous femoral access with steerable sheaths. TECHNIQUE: A 73-year-old female patient presented at our institution with intense abdominal pain. Angiotomography showed a 50-mm juxtarenal aortic aneurysm, with no signs of rupture. Urgent endovascular repair was indicated due to abdominal symptom with an off-the-shelf multi-branched endograft. To limit descending thoracic aortic coverage, we performed t-Branch modification to preserve intercostal arteries and minimize the risk of spinal cord injury, associated with a percutaneous transfemoral approach and branch incorporation with steerable sheaths to avoid the risks associated with a superior axillary or brachial access. Control angiotomography showed adequate aneurysm sac exclusion with patency of all four visceral vessels. CONCLUSION: t-Branch-modified endograft to limit aortic coverage is an alternative option in urgent cases to diminish the risk of spinal cord injury, and association of steerable sheaths with branch incorporation is leading complex aortic repairs to an even less invasive procedure. CLINICAL IMPACT: This paper highlights the possibility of performing complex endovascular aortic repair in an urgent setting with modification of an off-the-shelf multi branched endograft limiting intercostal arteries coverage, thereby diminishing the risk of spinal cord ischemia. This technical innovation provides an alternative for clinicians when treating large, rapidly expanding, or symptomatic juxtarenal, pararenal, paravisceral or type 4 thoracoabdominal aortic aneurysms that could not wait for a custom-made device and do not need extensive thoracic aortic coverage that an off-the-shelf device provides. In summary, expand the possibilities of an endovascular repair of complex aortic aneurysms.

Off-the-Shelf Single-Fenestrated Endograft for Emergent Juxtarenal and Pararenal Abdominal Aortic Aneurysm.

INTRODUCTION: Endovascular solutions to emergent juxtarenal and pararenal abdominal aortic aneurysms (AAAs) are complicated. Endovascular aortic repair (EVAR) with in situ laser fenestration (ISLF) is promising but requires a period of visceral ischemia. With an off-the-shelf, single superior mesenteric artery (SMA)-fenestrated device mesenteric ischemia is avoided and renal ischemia decreased. The aim was to develop an optimized design of such an endograft suitable for >90% of juxtarenal and pararenal AAAs. METHODS: Single-center analysis on 44 consecutive preoperative CTs for previously elective fenestrated EVARs for juxtarenal and pararenal aneurysms. Anatomical characteristics were analyzed to define: (1) shortest aortic coverage above SMA fenestration to achieve ≥4 cm seal; (2) feasibility of a scallop for the celiac artery; (3) shortest distance between the SMA and lowest renal, to facilitate renal ISLF in a straight endograft; (4) distance from the lowest renal to the aortic bifurcation, to allow an overlapping zone >40 mm with a bifurcated stent graft; (5) aortic diameter in the sealing zone, for optimal proximal stent graft diameter with 10% to 30% oversizing; (6) the final design was then tested on individual level. RESULTS: (1) The stent graft needs to start 40 mm above the SMA fenestration to achieve a 4 cm sealing zone in >90% of cases. (2) A proximal sealing zone of 40 mm without a scallop covers 77% of celiac arteries. With an addition of a 20 mm deep, 20 mm wide scallop at 12:30, the stent graft still covers 27% of celiacs. This suggests that a scallop would not be practically feasible. (3) In >90% of cases, the lowest renal was <31 mm from the SMA, suggesting that the tapering should start 30 mm below the SMA. (4) The distance from the lowest renal to the aortic bifurcation ranged from 82 to 166 mm. This allows for a 20 mm tapering and 50 mm straight part in all cases. (5) The 5th and 95th percentile of the aortic diameter in the sealing zone was 22 and 31 mm, respectively. Thus, 2 different stent graft diameters (28 and 34 mm) would fit >90% of cases. (6) The final design was suitable in 91% cases. CONCLUSIONS: Two sizes of a single-fenestrated aortic stent graft without scallop cover >90% of juxtarenal and pararenal anatomies. CLINICAL IMPACT: Emergent juxta- and pararenal aortic aneurysms is a difficult clinical scenario that continuously challenges physicians. An endovascular option is in situ laser fenestrated endografts. One risk with these is the complete visceral ischemia occurring before the fenestrations are completed. An off-the-shelf single-fenestrated stent graft facilitates the treatment by removing the ischemia time for the SMA and reducing the ischemia time for the celiac and renal arteries thus decreasing the risk of visceral ischemia complications.

Initial Outcomes of Physician-Modified Inner Branched Endovascular Repair in High-Surgical-Risk Patients.

PURPOSE: To report the initial outcomes of physician-modified inner branched endovascular repair (PMiBEVAR) for pararenal aneurysms (PRAs), thoracoabdominal aortic aneurysms (TAAAs), and aortic arch aneurysms in high-surgical-risk patients. MATERIALS AND METHODS: A total of 10 patients (6 men; median age, 83.0 years) treated using PMiBEVAR were enrolled in this retrospective, single-center study. All patients were at high surgical risk because of severe comorbidities (American Society of Anesthesiologists physical status score≥3 or emergency repair). End points were defined as technical success per patient and per vessel (successful deployment), clinical success (no endoleaks postoperatively), in-hospital death, and major adverse events. RESULTS: There were 3 PRAs, 4 TAAAs, and 3 aortic arch aneurysms with 12 renal-mesenteric arteries and 3 left subclavian arteries incorporated by inner branches. The technical success rate was 90.0% (9/10) per patient and 93.3% (14/15) per vessel. The clinical success rate was 90% (9/10). There were 2 in-hospital deaths, unrelated to aneurysms. Paraplegia and shower emboli occurred separately in 2 patients. Three patients experienced prolonged ventilation for 3 days after surgery. Aneurysm sac shrinkage occurred in 4 patients, and aneurysm size stabilized in 1 patient during follow-up, more than 6 months later. None of the patients required intervention. CONCLUSION: PMiBEVAR is a feasible approach for treating complex aneurysms in high-surgical-risk patients. This technology may complement the existing technology in terms of improved anatomical adaptability, no time delay and practicability in many countries. However, long-term durability remains undetermined. Further large-scale and long-term studies are needed. CLINICAL IMPACT: This is the first clinical study to investigate outcomes of physician-modified inner branched endovascular repair (PMiBEVAR). PMiBEVAR for treating pararenal aneurysm, thoracoabdominal aortic aneurysm, or aortic arch aneurysm is a feasible procedure. This technology is likely to complement existing technology in terms of improved anatomical adaptability (compared to off-the-shelf devices), no time delay (compared to custom-made devices), and the potential to be performed in many countries. On the other hand, surgery time varied greatly depending on the case, suggesting a learning curve and the need for technological innovation to perform more consistent surgeries.

Midterm Outcomes of Antegrade In Situ Laser Fenestration of Polyester Endografts for Urgent Treatment of Aortic Pathologies Involving the Visceral and Renal Arteries.

OBJECTIVE: Aortic endografting and antegrade in situ laser fenestration of visceral arteries (LFEVAR) may be considered as an alternative to open surgery for the emergency repair of complex abdominal aortic aneurysms (AAA) in fragile patients. The aim of this article was to evaluate the midterm results of LFEVAR performed with polyester endografts. METHODS: From August 2015 to December 2020, all consecutive LFEVAR performed for non-deferrable treatment of complex AAA were analysed. Polyester endografts were deployed and subsequently fenestrated using an atherectomy laser probe; the fenestrations were enlarged using cutting and semicompliant balloons before implantation of balloon expandable bridging stents into the target vessels. Prospectively collected midterm survival, patency, and re-intervention rates were analysed. RESULTS: Forty four procedures were performed for 11 type 1a endoleaks, five thoraco-abdominal aneurysms, 20 pararenal aneurysms, four segmental renal artery (RA) preservations, three anastomotic aneurysms, and one aortic dissection. One hundred and eight laser fenestrations were performed (26 for the superior mesenteric artery [SMA], 13 for the coeliac trunk, 33 and 31 for the right and left RA, respectively). The median ischaemia duration was 7, 48, 48, and 45 minutes, respectively. The technical success rate was 97%, with no open surgical conversions. The 30 day mortality was 4.5% (n = 2). No spinal cord ischaemia events were observed nor early stent related complications. Kaplan-Meier overall survival at two years was 73%, the aortic related re-intervention free survival was 70%, and the stent related re-intervention free survival was 90.6%. Four target vessel thromboses were detected, of which three were rescued. Three type IIIc endoleaks, one RA false aneurysm, and one SMA stenosis, required re-intervention during a median follow up of 24.7 months. CONCLUSION: Antegrade LFEVAR is feasible, safe, and provides satisfactory early and midterm outcomes for non-deferrable treatment of aortic pathologies involving the visceral segment. Long term data are mandatory to confirm the usefulness of this promising off label technique.

A SiMplified bARe-Wire Target Vessel (SMART) Technique for Fenestrated Endovascular Aortic Repair.

PURPOSE: The aim of this study was to present a new technique for fenestrated endovascular aortic aneurysm repair (FEVAR) and to review its preliminary results. The SiMplified bARe-wire Target vessel (SMART) technique for FEVAR aims to simplify the procedure by avoiding guiding sheaths into visceral arteries during the main graft deployment. MATERIALS AND METHODS: The SMART technique requires a 12 to 16Fr contralateral introducer, depending on number of fenestrations-compared with standard 18 to 22Fr for 3 to 4 FEVAR-to achieve target vessel catheterization and stenting during FEVAR by avoiding the use of parallel 6 to 7Fr guiding sheaths into each visceral vessel. Fenestrations are sequentially catheterized, assisted by a steerable sheath. A Rosen wire is maintained in each fenestration, with a single sheath parked in the final target vessel while releasing the fenestrated graft. Data on patients treated for pararenal or thoracoabdominal aortic aneurysms with FEVAR, adopting the SMART technique, were retrospectively reviewed. End points were technical success, intraprocedural variables, 90-day mortality, major adverse events (MAEs), and target vessel patency. RESULTS: From May 2018 to December 2020, 57 consecutive patients were treated for pararenal or thoracoabdominal aortic aneurysms. Median total procedure time and total fluoroscopy time were 223 (196-271) minutes and 81 (71-94) minutes, respectively. Primary technical success was 96.4% (55/57). No misalignment occurred from graft deployment. The total number of fenestrations was 169, including 54 left and 53 right renal arteries, 43 superior mesenteric arteries and 18 celiac trunks (3.0±0.9 vessels/patient), with target vessel technical success of 98.2%. During the first 90 days, there were no deaths (0%). The MAEs included acute kidney injury (AKI) in 3 patients (5%) with no new dialysis onset, respiratory failure requiring prolonged ventilation in 2 patients (4%), myocardial ischemia in 1 patient (2%), but no lower limb ischemia, stroke, or spinal cord ischemia (SCI) occurred. After a mean follow-up of 14±10 months, there was 1 aortic-related death. Primary and assisted primary target vessel patency was 94.6%±1.8 and 97.0%±1.3% respectively. CONCLUSIONS: The SMART technique proved to be a safe alternative to standard FEVARs, with excellent technical result and acceptable target vessel patency at mid-term, while reducing the risk for introducer-induced lower limb ischemia, related complications, and morbidity. CLINICAL IMPACT: This study evalautes the outcome of fenestrated endovascular aortic repair (FEVAR) procedures at Uppsala university hospital using a simplified bare-wire Target vessel (SMART) technique. The SMART technique requires a smaller contralateral introducer compared to standard 18-22Fr for 3-4 FEVAR to achieve target vessel catetherization and stenting. Fifty-seven consecutive patients were treated for pararenal or thoracoabdominal aortic aneurysms. The SMART technique proved to be a safe alternative to standard FEVARs with excellent technical result and acceptable target vessel patency at mid-term, while reducing the risk for introducer-induced lower limb ischemia, related complications, and morbidity.

Preoperative and postoperative predictors of clinical outcome of fenestrated and branched endovascular repair for complex abdominal and thoracoabdominal aortic aneurysms in an Italian multicenter registry.

OBJECTIVE: Complex aortic aneurysms (juxtarenal aortic aneurysms [JAAA], pararenal aortic aneurysms [PAAAs], thoracoabdominal aortic aneurysms TAAAs) are treated with increasing frequency through fenestrated and branched endovascular repair (F/B-EVAR); however, the outcome of these procedures is usually reported separately by single experiences and wider overviews are not frequent. The aim of this study was therefore to report an Italian experience analyzing the results obtained in four academic centers to evaluate the predictors of outcomes. METHODS: Between 2008 and 2019, all consecutive patients undergoing F/B-EVAR in four Italian university centers were recorded prospectively and analyzed retrospectively. Preoperative comorbidities and postoperative complications were classified according with the Society for Vascular Surgery reporting standard. Postoperative complications and 30-day/in-hospital mortality were assessed as early outcomes. Survival, freedom from reinterventions and target visceral vessels patency were assessed as follow-up outcomes by Kaplan-Meier analysis. Risk factors for 30-day/in-hospital mortality and spinal cord ischemia (SCI) were determined by multivariate analysis. Risk factors for follow-up mortality and reinterventions were evaluated by Cox regression model. RESULTS: Five hundred ninety-six patients underwent F/B-EVAR for 124 JAAAs (21%), 121 PAAAs (20%), and 351 TAAAs (59%). Elective and urgent procedures were performed in 520 (87%) and 76 (13%) cases, respectively. Postoperative cardiac, pulmonary, and renal complications were reported in 41 (7%), 50 (8%), and 80 (13%) patients, respectively. Seven bowel ischemia (1%) and 23 cerebrovascular complications (4%) occurred. Forty-seven (8%) patients suffered SCI with 17 cases (3%) of permanent paraplegia. Crawford's extent I-II-III TAAAs (odds ratio [OR], 13.41; 95% confidence interval [CI], 1.77-101.65; P = .012) and postoperative renal complications (OR, 3.84; 95% CI, 1.70-8.69; P = .001) independently predicted SCI. Thirty-two patients (5%) died in the perioperative period. Preoperative chronic renal failure (OR, 7.81; 95% CI, 7.81-26.31; P = .001), postoperative bowel ischemia (OR, 26.97; 95% CI, 3.37-215.5; P = .002), cardiac complications (OR, 5.77; 95% CI, 1.41-23.64; P ≤ .001), cerebrovascular complications (OR, 28.63; 95% CI, 5.20-157.5; P < .001), and SCI (OR, 5.99; 95% CI, 1.12-32.5; P = .036) were independently correlated with 30-day/in-hospital mortality. The mean follow-up was 25 ± 7 months. Freedom from target visceral vessels occlusion and freedom from reintervention were 96% and 92% at 1 year and 93% and 85% at 3 years, respectively. TAAAs (hazard ratio [HR]. 3.16; 95% CI, 1.68-5.92; P ≤ .001), postdissection TAAAs (HR, 2.20; 95% CI, 1.30-4.90; P = .05) and postoperative bowel ischemia (HR, 11.98; 95% CI, 1.53-93.31; P = .018) were independent predictors of reinterventions. Survival was 88% and 78% at 1 and 3 years, respectively. Preoperative chronic renal failure (HR, 2.39; 95% CI, 1.59-3.59; P ≤ .001), urgent repair (HR, 1.80; 95% CI, 1.03-3.20; P = .039), TAAAs (HR, 2.01; 95% CI, 1.13-3.56; P = .017), postoperative bowel ischemia (HR, 5.55; 95% CI, 2.11-14.59; P = .001), cardiac complications (HR, 3.89; 95% CI, 2.25-6.71; P ≤ .001), and pulmonary complications (HR, 1.97; 95% CI, 1.56-3.35; P = .013) were independent predictors of mortality during follow-up. CONCLUSIONS: F/B-EVAR is associated with satisfactory midterm outcomes in a nationwide experience. A variety of risk factors should be considered in F/B-EVAR indications and postoperative patient management to decrease the risk of postoperative complications and improve midterm outcomes.

Effect of thoracoabdominal aortic aneurysm extent on outcomes in patients undergoing fenestrated/branched endovascular aneurysm repair.

OBJECTIVE: The outcomes after open repair of thoracoabdominal aneurysms (TAAAs) have been definitively demonstrated to worsen as the TAAA extent increases. However, the effect of TAAA extent on fenestrated/branched endovascular aneurysm repair (F/BEVAR) outcomes is unclear. We investigated the differences in outcomes of F/BEVAR according to the TAAA extent. METHODS: We reviewed a single-institution, prospectively maintained database of all F/BEVAR procedures performed in an institutional review board-approved registry and/or physician-sponsored Food and Drug Administration investigational device exemption trial (trial no. G130210). The patients were stratified into two groups: group 1, extensive (extent 1-3) TAAAs; and group 2, nonextensive (juxtarenal, pararenal, and extent 4-5) TAAAs. The perioperative outcomes were compared using the χ2 test. Kaplan-Meier analysis of 3-year survival, target artery patency, reintervention, type I or III endoleak, and branch instability (type Ic or III endoleak, loss of branch patency, target vessel stenosis >50%) was performed. Cox proportional hazards modeling was used to assess the independent effect of extensive TAAA on 1-year mortality. RESULTS: During the study period, 299 F/BEVAR procedures were performed for 87 extensive TAAAs (29%) and 212 nonextensive TAAAs (71%). Most repairs had used company-manufactured, custom-made devices (n = 241; 81%). Between the two groups, no perioperative differences were observed in myocardial infarction, stroke, acute kidney injury, dialysis, target artery occlusion, access site complication, or type I or III endoleak (P > .05 for all). The incidence of perioperative paraparesis was greater in the extensive TAAA group (8.1% vs 0.5%; P = .001). However, the incidence of long-term paralysis was equivalent (2.3% vs 0.5%; P = .20), with nearly all patients with paraparesis regaining ambulatory function. On Kaplan-Meier analysis, no differences in survival, target artery patency, or freedom from reintervention were observed at 3 years (P > .05 for all). Freedom from type I or III endoleak (P < .01) and freedom from branch instability (P < .01) were significantly worse in the extensive TAAA group. Cox proportional hazards modeling demonstrated that F/BEVAR for extensive TAAA was not associated with 1-year mortality (hazard ratio, 1.71; 95% confidence interval, 0.91-3.52; P = .13). CONCLUSIONS: Unlike open TAAA repair, the F/BEVAR outcomes were similar for extensive and nonextensive TAAAs. The differences in perioperative paraparesis, branch instability, and type I or III endoleak likely resulted from the increasing length of aortic coverage and number of target arteries involved. These findings suggest that high-volume centers performing F/BEVAR should expect comparable outcomes for extensive and nonextensive TAAA repair.

Stent Graft Modification to Preserve Intercostal Arteries Using Thoracoabdominal Off-the-Shelf Multibranched (t-Branch) Endograft.

Purpose: To demonstrate an off-the-shelf multibranched (t-Branch) modification to allow intercostal arteries preservation during juxtarenal, pararenal, paravisceral, and extent IV thoracoabdominal aortic aneurysm repair. Technique: The t-Branch is an off-the-shelf device not customized for specific patient anatomy and may be offered for urgent endovascular repair for patients with complex aortic aneurysms. However, a concern when treating patients who do not aneurysms extending above the celiac axis is that the more proximal extension which is required with this device may render patients at high risk for spinal cord injury. We report a novel technique with t-Branch modification performing a 180° fabric back windows at the first 2 sealing stents that allow perfusion to the intercostal arteries. Conclusion: T-Branch-PIA (preserving intercostal arteries) modification limits intercostal arteries coverage while optimizing proximal seal zone in juxtarenal, pararenal, paravisceral, and extent IV thoracoabdominal aneurysms, thereby may decrease the risk of spinal cord injury.

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.

Use of Stainless-Steel, Balloon-Expandable Chimney Grafts Is Durable Though Caution Is Required When Lining Angulated Renal Arteries.

PURPOSE: To analyze the overall performance of flexible nitinol stents used to line chimney grafts (CGs) during chimney endovascular aneurysm repair (chEVAR) of pararenal pathologies. MATERIALS AND METHODS: A retrospective review was conducted of all 116 elective patients (mean age 74.3±7.2 years; 103 men) who underwent chEVAR with balloon-expandable Advanta V12/iCAST CGs in combination with the Endurant stent-graft between January 2009 and December 2017 at a single center. CG lining with a nitinol stent was electively performed in 43 target vessels of 32 patients. The Kaplan-Meier method was used to estimate the primary outcomes of CG patency and freedom from reintervention (FFR) at the patient level and according to the use of a stent to line the CG. Estimates are reported with the 95% confidence interval (CI). Adjusted odds ratios (ORs) were calculated to identify any confounding effect between the presence/absence of a stent lining or according to the number of CGs. RESULTS: The mean radiological follow-up was 27.3 months (range 22.1-32.6). During this time, 8 CGs (4.7%) became occluded, 6 of them were lined with stents. Restoration of patency was possible in 3 of the 4 occluded stents that were associated with symptoms. First-year primary patency estimates were 96.9% (95% CI 92.5% to 100%) for the unlined group vs 77.1% (95% CI 58% to 95.3%; p=0.001) for the lined group, while FFR was 87.6% (95% CI 79.9% to 95.2%) vs 83.4% (95% CI 68.1% to 98.6%; p=0.82), respectively. Lining represented an independent risk factor for CG occlusion (OR 9.9, p=0.006). CONCLUSION: CG lining performed mainly in angulated renal arteries during chEVAR was significantly associated with CG occlusion. These findings highlight the importance of not having the distal part of the CG impinge on the angulated segment of the target vessel.

Short- and Midterm Outcomes of Open Repair and Fenestrated Endografting of Pararenal Aortic Aneurysms in a Concurrent Propensity-Adjusted Comparison.

PURPOSE: To compare outcomes of patients treated for pararenal aortic aneurysms using fenestrated endovascular aneurysm repair (fEVAR) vs open surgical repair (OSR) in 3 high-volume centers. MATERIALS AND METHODS: A multicenter retrospective analysis was conducted of 200 pararenal abdominal aortic aneurysm patients electively treated with OSR (n=108) or fEVAR (n=92) from 1998 to 2015 at 3 tertiary institutions. Endpoints were 30-day morbidity and mortality, late reinterventions, visceral artery occlusion, and mortality. Analysis was conducted on the entire population and on a propensity score-matched population constructed on age, gender, coronary artery disease (CAD), and chronic renal failure. RESULTS: In the total cohort, fEVAR patients were significantly (p<0.001) older and had higher frequencies of CAD (p<0.001) and previous stroke (p=0.003). OSR patients had higher risk of perioperative morbidity (OR 2.5, 95% CI 1.09 to 5.71, p=0.033), specifically respiratory failure (OR 4.06, 95% CI 1.12 to 4.72, p=0.034). These findings were confirmed in the propensity-adjusted analysis, where cardiac complications were also higher after OSR (OR 12.8, 95% CI 0.07 to 0.21, p=0.02). No difference in perioperative mortality (2.2% in fEVAR vs 1.9% in OSR) was identified. Mean follow-up was 50 months (range 0-119). Four-year results showed higher survival (91.2% vs 69.3%, p=0.02) and freedom from reintervention (95.6% vs 77.8%, p=0.01) after OSR in the unmatched population, with a small but significant (p=0.021) difference in the risk of late visceral artery occlusion/stenosis after fEVAR. On propensity analysis, no differences in late survival were found between groups. CONCLUSION: fEVAR and OSR may afford similar early and midterm survival rates. Higher risks of perioperative systemic complications after OSR are counterbalanced by higher risks of late visceral vessel patency issues and need for reintervention after fEVAR. Both procedures are safe and effective in the long term in experienced centers, where patient evaluation should drive the treatment strategy.

Early Experience with the Use of Inner Branches in Endovascular Repair of Complex Abdominal and Thoraco-abdominal Aortic Aneurysms.

OBJECTIVES: Visceral arteries in fenestrated and branched endovascular repair (F/BEVAR) have been addressed by fenestrations or directional side branches. Inner branches, as used in the arch branched device, could provide an extra option for visceral arteries "unsuitable" for fenestrations or directional side branches. Early experience with the use of inner branches for visceral arteries in F/BEVAR is described. METHODS: All consecutive patients treated by F/BEVAR for complex abdominal aortic aneurysm (AAA) or thoraco-abdominal aneurysm (TAAA) using stent grafts with inner branches were included. Data were collected prospectively. RESULTS: Thirty-two patients (28 male, mean age 71.6 ± 8.3 years) were included. Seven (21.9%) patients had a complex AAA and 25 (78.1%) had a TAAA. A stent graft with inner branches only was used in four (12.5%) patients. The remaining 28 (87.5%) patients received a stent graft with fenestrations and inner branches. In total 52 vessels were targeted with inner branches. Technical success was achieved in all 32 (100%) patients. All 38 inner branch target vessels in grafts including fenestrations and inner branches were instantly catheterised (<1 minute), whereas catheterisation of target vessels in "inner branch only" grafts proved more difficult (<1 minute, n = 3; 1-3 min, n = 4; and >3 min, n = 7). The 30 day operative mortality was 3.1% (1/32). Estimated survival at 1 year was 80.0% ± 8.3%. During follow-up, four renal inner branches occluded in three patients. The estimated inner branch target vessel stent patency at 1 year was 91.9 ± 4.5%. The estimated freedom from re-intervention at 1 year was 78.4% ± 8.9%. CONCLUSIONS: Early data suggest that visceral inner branches might represent a feasible third option to address selected target vessels in F/BEVAR. Stent grafts with inner branch(es) in combination with fenestrations seem to be a better configuration than stent grafts with inner branches alone. Durability of the inner branch design needs further investigation.

Anatomical Applicability of Endovascular Aneurysm Sealing Techniques in a Consecutive Cohort of Fenestrated Endovascular Aneurysm Repairs.

PURPOSE: To determine how many endovascular aneurysm sealing (EVAS) procedures with/without off-label use of chimneys (ChEVAS) could have been performed in a cohort of patients who had undergone fenestrated endovascular aneurysm repair (FEVAR). METHODS: Sixty patients (median age 76.3 years; 54 men) who underwent FEVAR in our institution between 2013 and 2015 were selected for the study. The median aneurysm diameter was 62.0 mm (interquartile range 59.3, 69.0). Preoperative computed tomography angiograms (CTA) were anonymized and sent to 2 physicians with experience of more than 40 ChEVAS interventions. These ChEVAS planners were blinded to the study purpose and asked to agree upon an EVAS/ChEVAS plan. The primary outcome was the percentage of the FEVAR patients in whom an EVAS/ChEVAS was technically possible. The secondary outcomes were a comparison of seal zones, number of target vessels, and device cost. RESULTS: An EVAS-based intervention would have been technically possible in 56 (93.3%) of the FEVAR patients. The median proximal aortic seal zone was significantly more distal in the EVAS/ChEVAS procedures vs the FEVAR cases (zone 8 vs zone 7, p<0.001) and fewer target vessels were involved (median 2 vs 3, p<0.001). The cost of the EVAS/ChEVAS device was 66% of the FEVAR device. Planners would not currently advocate an EVAS-based intervention in 43 (76.8%) of these 56 patients due to concerns regarding the risk of migration associated with the lumen thrombus ratios observed. CONCLUSION: EVAS is technically feasible in the majority of patients undergoing FEVAR in our institution but currently advocated in only 23.2%. The seal zone was more distal, fewer target vessels were involved, and the device cost was lower in the planned EVAS/ChEVAS interventions.

Endovascular repair of a ruptured pararenal aortic aneurysm using the Nellix endovascular aneurysm sealing system and chimney grafts.

PURPOSE: To demonstrate the feasibility of emergent endovascular repair of a ruptured pararenal aneurysm using chimney grafts and the Nellix endovascular aneurysm sealing (EVAS) system to reduce the potential for endoleak from the gutters around the chimney grafts. CASE REPORT: A 74-year-old patient presented with a ruptured pararenal aneurysm. Because of anatomical considerations after previous aortic surgery, conventional endovascular aneurysm repair was deemed impossible. It was decided to exclude the aneurysm with a Nellix EVAS system in conjunction with two chimneys to the renal arteries, even though this was outside the instructions for use of the device. Active bleeding was stopped directly after positioning the chimneys and filling the endobags with polymer. Completion angiography showed aneurysm exclusion and patent renal arteries. Renal function remained stable, and the patient was discharged at the third postoperative day. At 6 months, duplex ultrasound and computed tomography showed patent stents and chimneys and no evidence of endoleak. CONCLUSION: Using chimney grafts in combination with the Nellix endoprosthesis in a ruptured pararenal aneurysm is feasible. However, more robust data on both chimney-EVAS and EVAS in ruptured cases are required.

Pararenal aortic aneurysm in situs inversus totalis: open repair with right retroperitoneal approach.

Situs inversus totalis (SIT) refers to a mirror-image reversal of the internal organ position. The coexistence of abdominal aortic aneurysm and SIT is extremely rare; very short series have been reported; therefore its prevalence has never been estimated. The presence of anatomical anomalies could increase operative risk. The authors describe a case of successfully repaired pararenal abdominal aortic aneurysm with a right retroperitoneal approach in situs inversus totalis.