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.

Endovascular repair of pararenal and thoracoabdominal aortic aneurysms with inner and outer off-the-shelf multibranched endografts: A systematic review and meta-analysis.

BACKGROUND: During the last years a great progress has been noted in device technology and operator experience in treating complex aortic aneurysms. Fenestrated and branched custom-made devices require detailed preoperative planning and production time that can take ≤12 weeks. During this awaiting period, aortic-related mortality is increased. To overcome this limitation, off-the-shelf standardized multibranched devices were launched in the market for the treatment of pararenal and thoracoabdominal aortic aneurysms (TAAAs). Our aim was to evaluate systematically all the published studies of off-the-shelf endografts for the treatment of pararenal and TAAAs. METHODS: We performed a systematic review to identify all the eligible studies that reported outcomes to the off-the-shelf with inner or outer multibranched devices and then conducted a qualitative synthesis and meta-analysis of the results. The main outcomes were technical success, mortality, target visceral vessel instability, major adverse events, and reintervention rates. We estimated pooled proportions and 95% confidence intervals (CIs). RESULTS: A total of 1605 study titles were identified by the initial search strategy, of which 13 (8 t-Branch, 3 E-nside, 1 We-Flow, and 1 TAMBE) were considered eligible for inclusion in the meta-analysis. A total of 595 patients (70% male) were identified among the eligible studies. In terms of procedures, 64.4% were elective, 19.2% (13.4% outer multibranched group [OMG]; 6.1% inner multibranched group [IMG]) were emergent, and 16.4% (15.6% OMG; 0.8% IMG) were urgent. The pooled technical success was 92.1% (95% CI, 83.8%-96.4%) and 96.9% (95% CI, 92.5%-98.8%) for the outer and inner multibranched endografts, respectively. The pooled 30-day mortality was 10.4 % (95% CI, 6.6%-16.1%,) and 4.2% (95% CI, 2.0%-8.6%) for the OMG and IMG, respectively. The pooled 30-day and late target visceral vessel instability for the OMG was 3.5% (95% CI, 2.0%-6.1%) and 6.2% (95% CI, 4.7%-8.0%) and for the IMG 10.4% (95% CI, 4.5%-22.5%) and 1.6% (95% CI, 0.7%-3.3%) respectively. CONCLUSIONS: This pooled analysis indicated good technical success and mortality rates for both devices despite the high rate of urgent procedures. Pararenal and TAAAs can be treated safely using the included devices. However, further studies are required to draw additional conclusions for the IMG owing to the small sample size.

Acute kidney injury in patients undergoing endovascular or open repair of juxtarenal or pararenal aortic aneurysms.

BACKGROUND: The aim of this cohort study was to report the proportion of patients who develop periprocedural acute kidney injury (AKI) after endovascular repair (ER) and open surgery (OS) in patients with juxta/pararenal abdominal aortic aneurysm and to assess potential risk factors for AKI. The study also aimed to report the short- and long-term outcomes of patients with and without AKI. METHODS: This was a multicenter cohort study of five European academic high-volume centers (>50 OS or 50 ER infrarenal AAA repairs, plus >15 complex AAA repairs per year). All consecutively treated patients were extracted from a prospective vascular surgical registry and the data were scrutinized retrospectively. The primary end point for this study was the development of AKI. AKI was diagnosed when there is a two-fold increase of serum creatinine or decrease of glomerular filtration rate of >50% within 1 week of AAA repair. Secondary end points included long-term mortality and end-stage renal disease (ESRD). RESULTS: AKI occurred in 16.6% of patients in the ER group vs 30.3% in the OS group (P < .001). The 30-day mortality rate was higher among patients with AKI in both ER (15.4% vs 3.1%; P = .006) and OS (13.2% vs 5.3%; P = .001) groups. Age, chronic kidney disease, presence of significant thrombus burden in the pararenal region, >1000 mL blood loss in ER group were associated with development of AKI. Age, diabetes mellitus, chronic kidney disease, presence of significant thrombus burden in the pararenal region, and a proximal clamping time of >30 minutes in the OS group were associated with the development of AKI, whereas renal perfusion during clamping was the protective factor against AKI development. After a median follow-up of 91 months, AKI was associated with higher mortality rates in both the ER group (58.9% vs 29.7%; P < .001) and the OS group (61.5% vs 27.3%; P < .001). After the same follow-up period, AKI was associated with a higher incidence of ESRD in both the ER group (12.8% vs 3.6%; P = .009) and the OS group (9.9% vs 2.9%; P < .001). CONCLUSIONS: The current study identified important pre and postoperative factors associated with AKI after juxta/pararenal abdominal aortic aneurysm repair. Patients with postoperative AKI had significantly higher short- and long term mortality and higher incidence of ESRD than patients without AKI.

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.

Off the Shelf Multibranched Endograft for Thoraco-Abdominal and Pararenal Abdominal Aortic Aneurysms: a Prospective, Single Centre Study of the G-Branch Endograft.

OBJECTIVE: To investigate outcomes of a novel, off the shelf multibranched endovascular stent graft for the treatment of thoraco-abdominal aortic aneurysm (TAAA) and pararenal abdominal aortic aneurysm (PAAA). METHODS: A prospective, single centre study including 15 patients (mean age, 63.4 ± 10.7 years; 13 male) with TAAA or PAAA treated from October 2019 to March 2021 with a G-Branch endograft (Lifetech Scientific, Shenzhen, China) featuring a mixed multibranch design with two inner and two outer branches for reconstruction of the visceral and bilateral renal arteries, respectively. Follow up assessments were scheduled before discharge and at 30 days, six and 12 months after the index procedure. Annual telephone interviews were performed beyond the initial 12 months. The Kaplan-Meier method was used to estimate cumulative mortality and morbidity rates after endovascular repair. RESULTS: Technical success was achieved in all 15 patients. Nine patients (60%) had TAAA and six (40%) had PAAA (mean maximum aneurysm diameter, 73.7 ± 15.8 mm). The median follow up was 31.4 months (range, 10.1 - 44.0 months). At 30 days, there was no death and 7% morbidity (one case of temporary spinal cord ischaemia on Day 4). At one year, the mortality rate was 7% (one death from stroke at 10 months) and morbidity was 13% (one other case of renal function decline at six months). There were no aneurysm dilatations, re-interventions, or access related complications, and two (13%) persistent type II endoleaks. The one year primary branch patency rate was 100% for the four renovisceral arteries in all 13 patients who underwent computed tomography examinations. One patient died of hepatocellular carcinoma 29 months post-operatively, resulting in an estimated three year mortality rate of 13%. CONCLUSION: The G-Branch endograft yielded high technical success with good early and midterm outcomes for the treatment of TAAA and PAAA. A large multicentre study is warranted.

The effect of supraceliac versus infraceliac landing zone on outcomes following fenestrated endovascular repair of juxta-/pararenal aortic aneurysms.

OBJECTIVE: With increasing experience in fenestrated endovascular aneurysm repair (FEVAR) over time, devices designed to treat juxta-/pararenal aortic aneurysms have evolved in complexity to extend to more proximal landing zones and incorporate more target vessels. We assessed perioperative outcomes in patients who underwent juxta-/pararenal FEVAR with supraceliac vs infraceliac sealing in the Vascular Quality Initiative. METHODS: We identified all patients who underwent elective FEVAR (commercially available FEVAR and physician-modified endografts) for juxta-/pararenal aortic aneurysms in the Vascular Quality Initiative between 2014 and 2021. Supraceliac sealing was defined as proximal sealing in aortic zone 5, or zone 6 with a celiac scallop/fenestration/branch or celiac occlusion. Primary outcomes were perioperative and 3-year mortality. Secondary outcomes included completion endoleaks, in-hospital complications, and factors associated with 3-year mortality. We calculated propensity scores and used inverse probability-weighted Cox regression and logistic regression modeling to assess outcomes. RESULTS: Among 1486 patients identified, 1246 patients (84%) underwent infraceliac sealing, and 240 patients (16%) underwent supraceliac sealing. Of the supraceliac patients, 74 (31%) had a celiac scallop, 144 (60%) had a celiac fenestration/branch, and 22 (9.2%) had a celiac occlusion (intentional or unintentional). After risk-adjusted analyses, there were no differences in perioperative mortality following supraceliac sealing compared with infraceliac sealing (2.3% vs 2.5%; hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.26-1.8; P = .42), or 3-year mortality (12% vs 15%; HR, 0.89; 95% CI, 0.53-1.5; P = .67). Compared with infraceliac sealing, supraceliac sealing was associated with lower odds of type-IA completion endoleaks (odds ratio [OR], 0.24; 95% CI, 0.05-0.67), but higher odds of any complication (12% vs 6.9%; OR, 1.6; 95% CI, 1.01-2.5) including cardiac complications (5.5% vs 1.9%; OR, 2.6; 95% CI, 1.3-5.1), lower extremity ischemia (3.0% vs 0.9%; OR, 3.2; 95% CI, 1.02-9.5), and acute kidney injury (16% vs 11%; OR, 1.6; 95% CI, 1.05-2.3). Though non-significant, there was a trend towards higher risk of spinal cord ischemia following supraceliac sealing compared with infraceliac sealing (1.7% vs 0.8%; OR, 2.2; 95% CI, 0.70-6.4). There were no differences in bowel ischemia between groups (1.7% vs 1.5%; OR, 0.83; 95% CI, 0.24-1.23). A more proximal aneurysm disease extent was associated with higher 3-year mortality (HR zone 8 vs 9, 1.7; 95% CI, 1.1-2.5), whereas procedural characteristics had no influence. CONCLUSIONS: Compared with sealing at an infraceliac level, supraceliac sealing was associated with lower risk of type IA endoleaks and similar mortality. However, clinicians should be aware that supraceliac sealing was associated with higher perioperative morbidity. Future studies with longer follow-up are needed to adequately assess durability differences to comprehensively weigh the risks and benefits of utilizing a higher sealing zone within the visceral aorta for juxta-/pararenal FEVAR.

Single-Center Experience With Inner-Branched Endograft for the Treatment of Pararenal Abdominal Aortic Aneurysms.

PURPOSE: To report a single-center result of patients with pararenal aneurysms treated with inner-branched endograft. MATERIALS AND METHODS: This retrospective study analyzed prospectively collected data of patients treated with elective inner-branched endovascular aneurysm repair (iBEVAR) using an Artivion® E-xtra custom-made endograft. Primary endpoints were clinical and technical success after iBEVAR. Secondary endpoints were overall survival, target vessel patency during follow-up, aneurysm-related mortality, and freedom from reintervention. RESULTS: Over a 56-month period, a total of 23 patients (19 men; 72.3±7.2 years) were treated with iBEVAR with a mean follow-up of 15 months. Technical success was achieved in 96% of procedures, incorporating 87 inner branches. Two (8.3%) intraoperative complications (target vessel dissection) were reported, without additional reinterventions needed. Two (8.3%) patients died within 30 days after initial procedure. One due to respiratory failure and the other from an ischemic stroke. During follow-up, 3 patients (13%) required reintervention, either to repair a type I or type III endoleak (n=2) or to place an iliac-branched device, that did not succeed during the initial iBEVAR procedure (n=1). Primary target vessel patency and freedom from reintervention during follow-up was, respectively, 98.9% and 87%. We revealed no aneurysm-related mortality. Overall survival was 78.3%. CONCLUSION: The present study confirms previous findings that iBEVAR on the Artivion® E-xtra design platform is an effective and safe procedure achieving high technical success rate in the treatment of pararenal abdominal aortic aneurysms. CLINICAL IMPACT: Inner branched stent-graft configuration combines the benefits of FEVAR and outer-branched stent-graft technology. Implementation of inner branches in stent-grafts is gradually becoming more widespread for the treatment of aneurysms. This report supports the safe and high technical success rate of inner branched stent-grafts in treatment of pararenal abdominal aortic aneurysms.

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.

Endovascular Treatment of Ruptured or Symptomatic Thoracoabdominal and Pararenal Aortic Aneurysms Using Octopus Endograft Technique: Mid-Term Clinical Outcomes.

OBJECTIVE: To evaluate the effectiveness and safety of using off-the-shelf "Octopus" technique to treat ruptured or symptomatic thoracoabdominal aortic aneurysm (TAAA) and pararenal abdominal aortic aneurysm (PRAAA). METHODS AND RESULTS: All cases who underwent "Octopus" technique from May 2016 to May 2019 at our center were retrospectively analyzed. A total of 10 cases (8 males) were included. The mean age was 54.5±14.2 years (range: 31-80 years). Eight cases presented as aneurysm rupture or impending rupture accepted emergency repair. Technical success, defined by placement of all endografts as planned, was achieved in all cases. A total of 30 target visceral branches were successfully cannulated, 9 celiac arteries were covered intentionally. Intraoperative endoleak was observed in 6 patients, all of them were gutter leak. During hospital stay, there was no death, no side branch occlusion or spinal cord ischemia. Median follow-up was 30 months (range: 12-50 months). One patient died of lung cancer at 14-month follow-up. There was no secondary endoleak. The primary endoleak were found spontaneously resolved in 3 cases at 7 days, 3-month, and 1-year imaging. One persistent endoleak totally resolved after sealing of gutter spaces at 4-month follow-up. The other 2 persistent endoleak decreased during follow-up, which are still under observation. The branch patency rate was 90.3% (28/31). All the 3 occluded branches were renal arteries. Branch occlusion occurred in 2 cases at 1-month follow-up and 1 case at 2-year follow-up, but renal insufficiency was not observed in these cases. Obvious aneurysm sac shrinkage (≥5 mm) was observed in all cases. The aneurysm size shrunk from 7.6±1.9 to 5.5±1.4 cm. No spinal cord ischemia occurred during follow-up. CONCLUSION: Treatment of ruptured TAAA and PRAAA with "Octopus" technique is feasible and safe for high surgical risk patients in the absence of fenestrated and branched devices. The long-term clinical outcomes needed to be investigated.

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.

First-in-Human Clinical Trial of the WeFlow-JAAA Endograft System in Patients With Juxtarenal Abdominal Aortic Aneurysms.

OBJECTIVE: To preliminarily evaluate the safety and efficacy of the WeFlow-JAAA endograft, a novel off-the-shelf device designed for the repair of juxtarenal abdominal aortic aneurysms (JRAAAs) and pararenal abdominal aortic aneurysms (PRAAAs). METHODS: This prospective single-arm first-in-human clinical trial included patients with JRAAAs (infrarenal necks ≤10 mm) or PRAAAs with at least a 5 mm sealing zone below the superior mesenteric artery (SMA) who underwent endovascular repair using the WeFlow-JAAA endograft system. With this system, the celiac artery was addressed with a wide scallop, the renal arteries (RAs) were addressed with 2 standard inner branches, and the SMA was addressed with a "mini-inner-cuff" reinforced fenestration. The primary efficacy endpoint was the clinical success at 12 months. The primary safety endpoint was the freedom from major adverse events (MAEs) in the first 30 days after surgery. RESULTS: Fifteen patients (all men; mean age 68.5±6.0 years) were enrolled between October 2019 and August 2021. The median infrarenal neck length was 0 mm (IQR, 0-4 mm). Technical success was achieved in all patients. No MAEs occurred in the first 30 days. The mean fluoroscopy time was 73.1±27.8 minutes, and the mean volume of contrast media was 130.7±29.4 mL. Clinical success was maintained in all patients at 12 months. No aortic-related deaths, aneurysm rupture, type I or type III endoleak, or open surgery conversion occurred during the follow-up period. The secondary intervention was required only in 1 patient who developed an occluded right RA stent 14 months after the procedure. CONCLUSION: The WeFlow-JAAA endograft device appears to be safe and efficacious in selected patients with JRAAAs or PRAAAs with more than 5 mm sealing zone below SMA. Large-scale, multicenter, and prospective studies with long-term follow-ups are ongoing to validate our findings in China. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT04745546 (URL: Guo's Visceral Arteries Reconstruction: The First in Man Study of WeFlow-JAAA Stent Graft System-Full-Text View-ClinicalTrials.gov). CLINICAL IMPACT: The first-in-human clinical trial of the WeFlow-JAAA endograft system demonstrates promising safety and efficacy in treating juxtarenal abdominal aortic aneurysms (JRAAAs) and partial pararenal abdominal aortic aneurysms (PRAAAs). This innovative off-the-shelf device offers a potential alternative to traditional endovascular aortic repair. The successful outcomes, including technical success in all patients, freedom from major adverse events, and maintenance of clinical success at 12 months, suggest a potential shift in clinical practice towards using the WeFlow-JAAA endograft system for selected patients. This study paves the way for larger-scale, multicenter, prospective studies to further validate its long-term safety and efficacy, offering clinicians a new option for managing complex abdominal 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.

Integration of a Custom-Made Fenestration to Simplify Acute Reno-Visceral In Situ Aortic Repair.

PURPOSE: To illustrate the technique of antegrade in situ laser fenestration (ISLF) on a predesign custom-manufactured stent-graft with single reinforced fenestration for use in emergency endovascular repair of complex abdominal aortic aneurysms (AAAs). TECHNIQUE: A short custom-made device (CMD) fenestrated graft was predesigned with a single preloaded 8 mm strut-free fenestration at 12 o'clock position. A modified preloaded system was used to allow unilateral access from the distal port if necessary. After bilateral percutaneous femoral access, the graft was deployed under fusion guidance with the CMD fenestration matching the superior mesenteric artery (SMA) origin and immediately bridged as per standard technique. The aneurysm was then excluded with a bifurcated device. A large steerable sheath was used to allow for sequential antegrade laser in situ fenestration and stenting of the renal arteries. CONCLUSIONS: Single-vessel customized short fenestrated grafts for the SMA and antegrade in situ laser renal fenestrations are technically feasible for repair of acute complex AAAs even after previous infrarenal reconstruction. It could become an off-the-shelf solution to limit aortic coverage and reno-visceral ischemia, even in patients with a narrow aortic diameter at the renal level. CLINICAL IMPACT: Single-vessel precustomized short fenestrated grafts for the SMA combined with renal artery antegrade ISLF can be a feasible option for the acute repair of patients with complex aneurysms and a narrow aortic diameter at the reno-visceral segment. It may limit aortic coverage and reno-visceral ischemic time and also be applicable after previous infrarenal endovascular aneurysm repair (EVAR).

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.

Short Term and Long Term Clinical Outcomes of Endovascular versus Open Repair for Juxtarenal and Pararenal Abdominal Aortic Aneurysms Using Propensity Score Matching: Results from Juxta- and pararenal aortic Aneurysm Multicentre European Study (JAMES).

OBJECTIVE: The aim of this study was to compare the short and long term clinical outcomes of endovascular (EVAR) vs. open surgical repair (OSR) of juxtarenal (JAAAs) and pararenal abdominal aortic aneurysms (PAAAs) in five high volume European academic centres. METHODS: This was a retrospective multicentre cohort study of five high volume European academic centres (> 50 open or 50 endovascular abdominal aortic aneurysm repairs annually) including 834 consecutive patients who were operated on and prospectively followed. Using propensity score matching (PSM) each patient who underwent OSR was matched with one patient who underwent EVAR in a 1:1 ratio (145 patients per group). The primary endpoint was long term all cause mortality, while the secondary endpoint was freedom from aortic related re-intervention. RESULTS: After a follow up of 87 months, no difference in overall survival between the two groups was observed (38.6% for EVAR vs. 42.1% for OSR; p = .88). Patients undergoing EVAR underwent aortic related re-interventions more frequently (24.1% vs. 6.9%; p < .001). Acute kidney injury (AKI) occurred more frequently in patients in the OSR group (40.7% vs. 24.8%; p = .006). However, most patients who suffered from AKI recovered without further progression to renal failure. In hospital (3.4% for EVAR vs. 4.1% for OSR; p = 1.0) and 30 day (4.1% for EVAR vs. 5.5% for OSR; p = .80) mortality rates did not differ between groups. CONCLUSION: Both open and endovascular treatment can be performed in high volume aortic centres with low short term mortality and morbidity rates, and good long term outcomes. These data provide useful information to help patients choose between the two procedures when both are feasible.

Additional Aortic Coverage With an Off The Shelf, Multibranched Endograft Compared With Custom Made Devices For Endovascular Repair of Pararenal Abdominal Aortic Aneurysms.

OBJECTIVE: Pararenal abdominal aortic aneurysms (p-AAA) require complex endovascular aortic repair or open surgical repair with suprarenal clamping. Custom made devices (CMD), including fenestrated and branched endovascular aortic repair (F/B-EVAR) or off the shelf (OTS) multibranched devices, are available treatment options. The aim of this study was to determine the additional healthy aortic coverage using an OTS multibranched endograft vs. a CMD for the treatment of p-AAAs. METHODS: This was a retrospective single centre analysis of prospectively collected data. Consecutive patients with p-AAAs requiring a proximal landing zone above the coeliac artery (CA), planned and treated with CMDs (Zenith Fenestrated) between January 2017 and December 2021 were included in this study. Treatment with supracoeliac coverage using available OTS multibranched devices was simulated using available pre-operative images: T-Branch; E-nside; and TAMBE. Study endpoints included the need for additional proximal aortic coverage, and the number of the segmental arteries additionally covered proximally from the CA for OTS devices compared with CMDs. RESULTS: Eighty three patients with p-AAAs were treated with CMDs (all FEVAR), including juxtarenal AAAs (n = 46; 56%), suprarenal AAAs (n = 20; 24%), and short neck AAAs (n = 17; 20%). In this study, treatment with 249 (3 × 83) OTS endografts was simulated. When compared with CMDs, OTS devices required a mean of 74 ± 19 mm of additional proximal healthy aortic coverage from the CA (CMD: 33 ± 19 mm vs. OTS: 108 ± 6 mm; p ≤ .001), as well as an average sacrifice of 2.5 additional segmental arteries (CMD: 1.3 ± 0.8 vs. OTS: 3.8 ± 0.9; p ≤ .001). In 94% of patients, at least one of the available multibranched endografts could have been implanted in accordance with instructions for use. CONCLUSION: Despite not requiring customisation time, OTS endografts for the treatment of p-AAA lead to more extensive healthy aortic coverage, as well as an average sacrifice of 2.5 additional segmental arteries, compared with CMDs. When compared with OTS devices, CMDs appear to limit the extent of unnecessary aortic coverage and the theoretical subsequent risk of spinal cord ischaemia.

Endovascular repair of abdominal and thoracoabdominal aneurysms using chimneys and periscopes is associated with poor outcomes.

OBJECTIVE: Chimneys and periscopes are often used to treat pararenal or thoracoabdominal aneurysms de novo or after failed open or endovascular repair. We sought to describe our institutional experience, given their limited success and questionable long-term outcomes. METHODS: We retrospectively reviewed the electronic records for patients treated with chimneys/periscopes from 1997 through 2020. Baseline characteristics, procedural details, periprocedural complications, reinterventions, and midterm outcomes were collected. RESULTS: Fifty-eight patients (86 vessels) were treated; the median follow-up was 32 months (range, 0.03-104 months). There were 36% (n = 21) juxta-renal, 2% (n = 1) para-visceral, and 21% (n = 12) thoracoabdominal aneurysms, and 41% (n = 24) had pararenal failure of prior endovascular aneurysm repair (n = 17) or open repair (n = 7). Stent configuration for the majority of the 86 vessels (n = 80; 93%) treated were chimney configuration (n = 6 periscopes; 7%). The most common stent graft utilized was Viabahn, and 8.1% (n = 7) were reinforced with a bare metal stent. Although the majority of the cases were elective, 36.2% (n = 21) of the cases were urgent/emergent. At the conclusion of the initial procedure, 16 of 58 patients had an endoleak (gutter, 50% [8/16]; type Ia, 25% [4/16]; and type II, 25% [4/16]). On follow-up, 14 of 58 patients developed one or more endoleaks, with the most common endoleaks being a gutter endoleak (35% [7/20]). Other endoleaks observed included 30% (6/20) type III, 15% (3/20) type Ia, 15% (3/20) type Ib, and 5% (1/20) type II. Eleven of 58 patients underwent interventions for one or more endoleak (gutter, 33% [5/15]; type Ib, 20% [3/15]; type II, 7% [1/15]; and type III, 40% [6/15]). Twelve of 58 patients returned to the operating room for one or more procedures during the index hospitalization (five laparotomies, three dialysis access, three acute limb ischemia, and four chimney/periscope interventions). Ten of 58 patients underwent angioplasty/stenting for chimney/periscope compression or occlusion during the follow-up period. Survival was 61.3% at 1 year by Kaplan-Meier analysis (75% for elective, 37% for urgent/emergent) (aneurysm-related death, 22%). Cox hazard modeling showed that aneurysm diameter (hazard ratio, 1.03; 95% confidence interval, 1.004-1.05; P = .02) and urgent/emergent interventions (hazard ratio, 3.6; 95% confidence interval, 1.33-9.74; P = .01) were predictors of mortality. CONCLUSIONS: Endovascular repair of aortic aneurysms with chimneys/periscopes is associated with poor outcomes, including limited technical success and aneurysm exclusion, as well as high morbidity and mortality, with a high rate of reinterventions both in the immediate postoperative period and on follow-up. They should be used only when other surgical or endovascular options are not possible.

Pararenal Fat and Renal Dysfunction in Patients without Significant Cardiovascular Disease.

INTRODUCTION: Accumulation of fat tissue around the kidneys is considered to be a risk factor for chronic kidney disease (CKD). The objective of the study was to investigate the association of pararenal fat tissue (PRFT) and renal dysfunction in patients without clinically significant cardiovascular diseases (CVDs). METHODS: The study included 320 patients without CVDs (mean age 63.8 ± 13.9 years). All patients underwent anthropometric measurements, standard biochemical blood tests, including a lipid panel and uric acid concentration. Glomerular filtration rate (GFR) was calculated using the CKD-EPI formula. All patients underwent computed tomography of the abdomen with measurement of the PRFT thickness. The research results were processed using StatSoftStatistica 10.0 software. RESULTS: The average PRFT thickness was 1.45 cm [0.9; 2.0]. It was significantly higher in obese individuals when compared with patients with normal body weight (1.9 cm [1.3; 2.6] vs. 1.0 cm [0.6; 1.7]) and overweight people (1.9 cm [1.3; 2.6] vs. 1.1 cm [0.8; 1.6]) (p < 0.001). GFR was significantly higher in subjects with normal body weight when compared with obese patients (72 mL/min/1.73 m2 [59; 83] vs. 61 mL/min/1.73 m2 [51; 70]) and overweight patients (72 mL/min/1.73 m2 [59; 83] vs. 61 mL/min/1.73 m2 [54; 72]) (p < 0.001). PRFT thickness was significantly higher in patients with stage 3 CKD when compared with those with stage 1 CKD (2.2 cm [1.6; 3.3] vs. 0.9 cm [0.9; 1.0]) and with stage 2 CKD (2.2 cm [1.6; 3.3] vs. 1.3 cm [0.9; 1.8]) (p < 0.001). A significant correlation was found between PRFT thickness and body mass index (r = 0.49, p < 0.05), waist circumference (r = 0.55, p < 0.05), GFR (r = -0.47, p < 0.05), and uric acid level (r = 0.46, p < 0.05). Multiple linear regression analysis revealed a significant relationship between GFR and age (ß ± SE -0.43 ± 0.15, p = 0.01), PRFT thickness (ß ± SE -0.38 ± 0.14, p = 0.01) and with the level of low-density lipoprotein cholesterol (ß ± SE -0.32 ± 0.12, p = 0.01). Logistic regression analysis showed that the risk of renal dysfunction development was associated with PRFT thickness (OR = 6.198; 95% CI: 1.958-19.617; p < 0.05). ROC analysis determined the threshold values of PRFT thickness (>1.68 cm, AUC = 0.875), above which the development of renal dysfunction can be predicted (sensitivity 63.2%, specificity 93.4%). CONCLUSION: The results of our study indicate the relationship between PRFT and visceral obesity and renal dysfunction in patients without clinically significant CVDs.