Early multicentric outcomes of the on-label and CE-marked combination of the Endurant with the Radiant chimney graft for the chimney endovascular aortic repair (EnChEVAR): The LaMuR Registry.

BACKGROUND: The aim of this study was to evaluate the early results of the CE-marked standardized device combination consisting of Endurant and the Radiant chimney graft (En-ChEVAR) for the treatment of juxtarenal aortic aneurysms. METHODS: We analyzed multicentric non-industry sponsored case series evaluating the EnChEVAR technique for patients treated between December 2022 and February 2024. Clinical, perioperative procedure-related and radiological data were collected. The primary outcome measure was the freedom of a type Ia gutter-related endoleak at postoperative computed tomography angiography (CTA). Secondary outcome measures included early type Ia endoleak-related reinterventions, target vessel complications including dissection or loss of target vessel, major adverse events, and mortality. Continuous variables were presented as median (interquartile range [IQR]) and categorical variables as count and percentage. RESULTS: Ten patients were included in the present study. Eight (80%) were males, in nine cases a single chimney was implanted, and the other one was a double chimney graft placement. The treated aneurysms had an infrarenal neck length of 3.4 (1.2) mm. The rate of main body oversizing was 30%. The new neck length after chimney graft placement was 18 (3) mm. The median procedural time was 130 (17) mm, contrast medium use was 109 (26) mL, radiation time was 45 (12) min. The technical success was 100%. No type Ia endoleak was detected at the postoperative CTA. There were no target vessel issues. No major adverse events or death were observed. CONCLUSIONS: First reported cohort of patients treated with EnChEVAR demonstrated reproducible clinical and procedural outcomes within the 3 vascular centers with total exclusion of the aneurysms, patent renal arteries, and no evidence of gutter-related type IA endoleak. Further evidence with larger sample size of treated patients and longer follow-up are needed.

[Partial Arch Repair for Reruptured Aortic Arch Aneurysm due to Endoleak After 2-debranching Thoracic Endovascular Aortic Repair:Report of a Case].

A 67-year-old male was admitted to our hospital for sudden onset chest pain and hoarseness. He underwent 2-debranching thoracic endovascular aortic repair for a ruptured aortic arch aneurysm four years prior. However, computed tomography (CT) revealed an aneurysmal rerupture due to a typeⅠa endoleak. We performed partial arch replacement with uncovered stent removal under intermittent hypothermic circulatory arrest. We needed to be more careful than usual open heart surgery because a non-anatomical bypass procedure was performed. The surgery was successful without any major complications, and the patient was discharged on the 23th postoperative day. Reinterventions post-endovascular repair are sometimes difficult;thus, open surgery could be useful for arch replacement.

Outcomes of thoracic endovascular aortic repair using fenestrated stent grafts in patients with thoracic aortic distal arch aneurysms.

OBJECTIVES: Thoracic endovascular aortic repair (TEVAR) for aortic arch aneurysms is challenging because of anatomical restrictions and the presence of cervical branches. Revascularization of the cervical branch is required when conventional commercial stent grafts are used. TEVAR using fenestrated stent grafts (FSG) often does not require additional procedures to revascularize cervical branches. This study aimed to evaluate the features and initial and midterm outcomes of TEVAR using fenestrated stent grafts. METHODS: From April 2007 to December 2016, 101 consecutive patients underwent TEVAR using fenestrated stent grafts for distal aortic arch aneurysms at a single centre. Technical success, complications, freedom from aneurysm-related death, secondary intervention and aneurysm progression were retrospectively investigated. RESULTS: All the patients underwent TEVAR using fenestrated stent grafts. The 30-day mortality rate was zero. Cerebral infarction, access route problems and spinal cord injury occurred in 4, 3 and 2 patients, respectively. Each type of endoleak was observed in 38 of the 101 patients during the course of the study; 20/38 patients had minor type 1 endoleaks at the time of discharge. The endoleak disappeared in 2 patients and showed no significant change in 8 patients; however, the aneurysm expanded over time in 10 patients. Additional treatment was performed in 8 of the 10 patients with type 1 endoleaks and dilatation of the aneurysm. The rate of freedom from aneurysm-related death during the observation period was 98%. CONCLUSIONS: TEVAR with FSG is a simple procedure, with few complications. Additional treatment has been observed to reduce aneurysm-related deaths, even in patients with endoleaks and enlarged aneurysms. Based on this study, the outcomes of endovascular repair of aortic arch aneurysms using a fenestrated stent graft seem acceptable.

Importance of sac regression after EVAR and the role of EndoAnchors.

The initial success and widespread adoption of endovascular aneurysm repair (EVAR) for the treatment of abdominal aortic aneurysms have been tempered by numerous reports of secondary interventions and increased long-term mortality compared with open repair. Over the past decade, several studies on postoperative sac dynamics after EVAR have suggested that the presence of sac regression is a benign feature with a favorable prognosis. Conversely, increasing sacs and even stable sacs can be indicators of more unstable sac behavior with worse outcomes in the long-term. Endoleaks were initially perceived as the main drivers of sac behavior. However, the observation that sac regression can occur in the presence of endoleaks, and vice versa - increasing sacs without evidence of endoleak - on imaging studies, suggests the involvement of other contributing factors. These factors can be divided into anatomical factors, patient characteristics, sac thrombus composition, and device-related factors. The shift of interest away from especially type 2 endoleaks is further supported by promising results with the use of EndoAnchors regarding postoperative sac behavior. This review provides an overview of the existing literature on the implications and known risk factors of post-EVAR sac behavior, describes the accurate measurement of sac behavior, and discusses the use of EndoAnchors to promote sac regression.

Local Anesthesia for Endovascular Repair of Abdominal Aortic Aneurysm Allows for Accurate Graft Deployment with Durable Results.

BACKGROUND: Local anesthesia (LA) is sparsely used in endovascular aneurysm repair (EVAR) despite short-term benefit, likely secondary to concerns over patient movement preventing accurate endograft deployment. The objective of this study is to examine the association between anesthesia type and endoleak, sac regression, reintervention, and mortality. METHODS: The Vascular Quality Initiative database was queried for all EVAR cases from 2014 to 2022. Patients were included if they underwent percutaneous elective EVAR with anatomical criteria within instructions for use of commercially approved endografts. Multivariable logistic regression with propensity score weighting was used to determine the association between anesthesia type on the risk of any endoleak noted by intraoperative completion angiogram and sac regression. Multivariable survival analysis with propensity score weighting was used to determine the association between anesthesia type and endoleak at 1 year, long-term reintervention, and mortality. RESULTS: Thirteen thousand nine hundred thirty two EVARs met inclusion criteria: 1,075 (8%) LA and 12,857 (92%) general anesthesia (GA). On completion angiogram, LA was associated with fewer rates of any endoleaks overall (16% vs. 24%, P < 0.001). On multivariable analysis with propensity score weighting, LA was associated with similar adjusted odds of any endoleak on intraoperative completion angiogram (odds ratio [OR] 0.56, 95% confidence interval [CI] 0.47-0.68) as well as combined type 1a and type 1b endoleaks (OR 0.72, 95% CI 0.47-1.09). Follow-up computed tomography imaging at 1 year was available for 4,892 patients, 377 (8%) LA and 4,515 (92%) GA. At 1 year, LA was associated with similar rate of freedom from any endoleaks compared to GA (0.66 [95% CI 0.63-0.69] vs. 0.71 [95% CI 0.70-0.72], P = 0.663) and increased rates of sac regression (50% vs. 45%, P = 0.040). On multivariable analysis with propensity score weighting, LA and GA were associated with similar adjusted odds of sac regression (OR 1.22, 95% CI 0.97-1.55). LA and GA had similar rates of endoleak at 1 year (hazard ratio [HR] 0.14, 95% CI 0.63-1.07); however, LA was associated with decreased hazards of combined type 1a and 1b endoleaks at 1 year (HR 0.87, 95% CI 0.80-0.96). LA and GA had similar adjusted long-term reintervention rate (HR 0.77, 95% CI 0.44-1.38) and long-term mortality (HR 1.100, 95% CI 079-1.25). CONCLUSIONS: LA is not associated with increased adjusted rates of any endoleak on completion angiogram or at 1-year follow-up compared to GA. LA is associated with decreased adjusted rates of type 1a and type 1b endoleak at 1 year, but similar rates of sac regression, long-term reintervention, and mortality. Concerns for accurate graft deployment should not preclude use of LA and LA should be increasingly considered when deciding on anesthetic type for standard elective EVAR.

Selective aneurysmal sac neck-targeted embolization during endovascular repair of abdominal aortic aneurysm with hostile neck anatomy.

PURPOSE: To evaluate the efficacy and safety of selective aneurysmal sac neck-targeted embolization in endovascular aneurysm repair (EVAR) in patients with a hostile neck anatomy (HNA). MATERIALS AND METHODS: Between October 2020 and June 2022, patients with an abdominal aortic aneurysm (AAA) and HNA who underwent EVAR with a low-profile stent graft and a selective aneurysmal sac neck-targeted embolization technique were analysed. An HNA was defined by the presence of any of the following parameters: infrarenal neck angulation > 60°; neck length < 15 mm; conical neck; circumferential calcification ≥ 50%; or thrombus ≥ 50%. Before occluding the entire aneurysm during the procedure, a buddy wire was loaded prophylactically into the sac through the contralateral limb side. If a type Ia endoleak (ELIa) occurred and persisted despite adjunctive treatment such as balloon moulding or cuff extension, this preloaded wire could be utilized to enable a catheter to reach the space between the stent graft and sac neck to perform coil embolization. In the absence of ELIa, the wire was simply retracted. The primary outcome of this study was freedom from sac expansion and endoleak-related reintervention during the follow-up period; secondary outcomes included technical success and intraoperative and in-hospital postoperative complications. RESULTS: Among the 28 patients with a hostile neck morphology, 11 (39.5%) who presented with ELIa underwent intraprocedural treatment involving sac neck-targeted detachable coil embolization. Seventeen individuals (60.7%) of the total patient population did not undergo coiling. All patients in the coiling group underwent balloon moulding, and 2 patients additionally underwent cuff extension. In the noncoiling group, 14 individuals underwent balloon moulding as a treatment for ELIa, while 3 patients did not exhibit ELIa during the procedure. The coiling group showed longer operating durations (81.27 ± 11.61 vs. 70.71 ± 7.17 min, P < 0.01) and greater contrast utilization than the noncoiling group (177.45 ± 52.41 vs. 108.24 ± 17.49 ml, P < 0.01). In the entire cohort, the technical success rate was 100%, and there were no procedure-related complications. At a mean follow-up of 18.6 ± 5.2 months (range 12-31), there were no cases of sac expansion (19 cases of sac regression, 67.86%; 9 cases of stability, 32.14%) or endoleak-related reintervention. CONCLUSIONS: Selective aneurysmal sac neck-targeted embolization for the treatment of ELIa in AAA patients with an HNA undergoing EVAR is safe and may prevent type Ia endoleak and related sac expansion after EVAR.

Large-Diameter Fenestrated Endograft Repair of Abdominal Aortic Aneurysms Is Not Associated With Medium-Term Outcomes.

INTRODUCTION: Recent data suggests that infrarenal abdominal aortic aneurysm (AAA) endovascular repair (EVAR) with large diameter grafts (LGs) may have a higher risk of endoleak and reintervention. However, this has not been studied extensively for fenestrated endovascular aneurysm repair (fEVAR). We, therefore, sought to evaluate the outcomes of patients undergoing fEVAR with large-diameter endografts. METHODS: Patients from the national Vascular Quality Initiative registry who underwent fEVAR for intact juxtarenal AAA were identified. Patients with genetic causes for aneurysms, those with prior aortic surgery, and those undergoing repair for symptomatic or ruptured aneurysms were excluded. Rates of endoleaks and reintervention at periprocedural and long-term follow-up timepoints (9-22 mo) were analyzed in grafts 32 mm or larger (LG) and were compared to those smaller than 32 mm (small diameter graft). RESULTS: A total of 693 patients (22.8% LG) were identified. Overall, demographic variables were comparable except LG exhibited a more frequent history of coronary artery disease (32.9% versus 25.4%, P = 0.037). There were no significant differences in the rates of endoleak at procedural completion. Overall survival at 5 y was no different. The rate of reintervention at 1 y was also no different (log-rank P = 0.86). CONCLUSIONS: While graft size appears to have an association with outcomes in infrarenal aneurysm repair, the same does not appear to be true for fEVAR. Further studies should evaluate the long-term outcomes associated with LG which could alter the approach to repair of AAA with large neck diameters traditionally treated with standard infrarenal EVAR.

Contrast-Enhanced Ultrasound after Endovascular Aortic Repair: Supplement and Potential Substitute for CT in Early- and Long-Term Follow-Up.

BACKGROUND: Endoleaks are the most common complication after endovascular aneurysm repair (EVAR). Computed tomography angiography (CTA) is presently the golden standard for lifelong surveillance after EVAR. Several studies and meta-analyses have shown contrast-enhanced ultrasound (CEUS) to be a good alternative. The main goal of our study was to further validate the inclusion of CEUS in follow-up examination protocols for the systematic surveillance after EVAR. METHODS: A retrospective analysis of patients who had received CEUS as part of their routine surveillance after EVAR at our center was conducted. Detection rate and classification of endoleak types were compared between available postinterventional CTA/magnetic resonance angiography and follow-up CEUS examinations. Last preinterventional CTAs before EVAR served as baselines with focus on potential cofactors such as age, body mass index, maximum aortic aneurysm diameters, endoleak orientation, and distance-to-surface influencing detection rates and classification. RESULTS: In total, 101 patients were included in the analysis. Forty-four endoleaks (43.5% of cases) were detected by either initial CEUS or CTA, mostly type II (37.6% of the included patients). Initial CEUS showed an endoleak sensitivity of 91.2%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 84.6%. No covariate with an influence on the correct classification could be identified either for CEUS or CT. CONCLUSIONS: CEUS should be considered a valid complementary method to CTA in the lifelong surveillance after EVAR. As type II endoleaks seem to be a common early-term, sometimes spontaneously resolving complication that can potentially be missed by CTA, we suggest combined follow-up protocols including CEUS in the early on postinterventional assessment.

Efficacy of Sac Coil Embolization in Endovascular Aortic Repair for Sac Shrinkage in Patients at a High Risk of Type II Endoleak from Lumbar Arteries.

BACKGROUND: In endovascular aortic repair (EVAR), preemptive embolization of sac branch vessels is effective in preventing postoperative type II endoleak (T2EL). However, this technique has not been widely adopted especially for lumbar arteries (LAs) because of technical difficulties and time constraints. This study aimed to investigate the efficacy of nonselective sac coil embolization, which is a simpler surgical method, in postoperative sac shrinkage for patients at a high risk of T2EL from LAs. METHODS: We retrospectively assessed 76 patients who underwent elective EVAR for abdominal aortic aneurysm with 4 or more patent LAs or at least 1 patent LA of ≥2 mm at our hospital between January 2014 and December 2022. The patients who underwent sac coil embolization were included in Group Ⅰ (n = 20), and the others were divided into 2 groups: those with an inferior mesenteric artery that was originally occluded or embolized by coils or stent graft bodies (Group Ⅱ, n = 21), and those without that (Group Ⅲ, n = 35). In Group Ⅰ, 0.035-inch coils were inserted into the sac after complete stent graft deployment. The cumulative incidence of sac shrinkage (≥5 mm) was compared between the groups. Further, univariable and multivariable Cox regression analyses were used to determine the predictors of sac shrinkage. RESULTS: Sac shrinkage (≥5 mm) was observed more frequently in Group Ⅰ (50%) than in Group Ⅱ (19%) and Group Ⅲ (17%) (P = 0.052 and 0.043, respectively). The cumulative incidence of sac shrinkage was significantly higher in Group Ⅰ than in Group Ⅱ (log-rank P = 0.039) and Group Ⅲ (log-rank P = 0.024). Multivariable Cox regression analyses revealed that sac embolization was a significant predictor of sac shrinkage (hazard ratio, 4.23; 95% confidence interval, 1.66-10.8; P = 0.003). CONCLUSIONS: Nonselective sac coil embolization in EVAR is potentially effective for sac shrinkage in the early postoperative phase in patients at high risk of T2EL from LAs. This simple procedure may improve prognosis after EVAR.

One-year follow-up after active aortic aneurysm sac treatment with shape memory polymer devices during endovascular aneurysm repair.

OBJECTIVE: To determine the safety and efficacy of treating abdominal aortic aneurysm (AAA) sacs with polyurethane shape memory polymer (SMP) devices during endovascular aneurysm repair (EVAR), using a technique to fully treat the target lumen after endograft placement (aortic flow volume minus the endograft volume). SMP devices self-expand in the sac to form a porous scaffold that supports thrombosis throughout its structure. METHODS: Two identical prospective, multicenter, single-arm studies were conducted in New Zealand and the Netherlands. The study population was adult candidates for elective EVAR of an infrarenal AAA (diameter of ≥55 mm in men and ≥50 mm in women). Key exclusion criteria were an inability to adequately seal a common iliac artery aneurysm, patent sac feeding vessels of >4 mm, and a target lumen volume of <20 mL or >135 mL. Target lumen volumes were estimated by subtracting endograft volumes from preprocedural imaging-based flow lumen volumes. SMP devices were delivered immediately after endograft deployment via a 6F sheath jailed in a bowed position in the sac. The primary efficacy end point was technical success, defined as filling the actual target lumen volume with fully expanded SMP at the completion of the procedure. Secondary efficacy outcome measures during follow-up were the change in sac volume and diameter, rate of type II endoleak and type I or III endoleaks, and the rate of open repair and related reinterventions, with data collection at 30 days, 6 months, and 1 year (to date). Baseline sac volumes and diameters for change in sac size analyses were determined from 30-day imaging studies. Baseline and follow-up volumes were normalized by subtraction of the endograft volume. RESULTS: Of 34 patients treated with SMP devices and followed per protocol, 33 patients were evaluable at 1 year. Preprocedural aneurysm volume was 181.4 mL (95% confidence interval [CI], 150.7-212.1 mL) and preprocedural aneurysm diameter was 60.8 mm (95% CI, 57.8-63.9 mm). The target lumen volume was 56.3 mL (95% CI, 46.9-65.8 mL). Technical success was 100% and the ratio of SMP fully expanded volume to estimated target lumen volume was 1.4 ± 0.3. Baseline normalized sac volume and diameter were 140.7 mL (95% CI, 126.6-154.9 mL) and 61.0 mm (95% CI, 59.7-62.3 mm). The adjusted mean percentage change in normalized volume at 1 year was -28.8% (95% CI, -35.3 to -22.3%; P < .001). The adjusted mean change in sac diameter at 1 year was -5.9 mm (95% CI, -7.5 to -4.4 mm; P < .001). At 1 year, 81.8% of patients (95% CI, 64.5%-93.0%) achieved a ≥10% decrease in normalized volume and 57.6% of patients (95% CI, 39.2%-74.5%) achieved a ≥5 mm decrease in diameter. No device- or study procedure-related major adverse events occurred through 1 year after the procedure. CONCLUSIONS: Treatment of AAA sacs with SMP devices during EVAR resulted in significant sac volume and diameter regression at 1 year with an acceptable safety profile in this prospective study.

Midterm outcomes of side branch embolization and endovascular abdominal aortic aneurysm repair.

OBJECTIVE: To analyze the effects of total side branch embolization at endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms on the incidences of persistent type 2 endoleak (pT2EL), changes in sac diameter, and reintervention. METHODS: Between 2013 and 2021, all patients who underwent primary EVAR with a few exceptions were included. Side branch embolization was considered during EVAR for inferior mesenteric artery (IMA) or IMA plus lumbar artery (LA) when feasible for contrast agent use. Outcomes measured were pT2EL, sac diameters, reintervention, ruptures, and aneurysm-related mortality. Radiation exposure and safety outcomes were also reported. RESULTS: Among 732 patients who underwent EVAR, 616 (84.2%) were included. Of the 616 patients, 223 (36.2%) did not undergo side branch embolization (NO-E), whereas 228 (37.0%) underwent IMA only (IMA-E) and 165 (26.8%) underwent IMA+LA including median sacral artery (IMA+LA-E). The technical success rate of IMA and LA embolization was 97.0% and 74.7%, respectively. Crude incidences of pT2EL were significantly different from 6 months through 3 years (NO-E, 27.8%; IMA-E, 31.7%; IMA+LA-E, 9.4% at 3 years; P = .007). In the multivariate analysis adjusted for background differences, the incidences of pT2EL were significantly higher in the NO-E (odds ratio [OR], 3.21; 95% confidence intervals [CIs], 1.08-9.57; P = .004) and IMA-E (OR, 4.86; 95% CIs, 1.68-14.11; P = .004) compared with the IMA+LA-E group. Similarly, any reintervention until 3 years was significantly frequent in the NO-E (OR, 5.26; 95% CIs, 1.76-15.70; P = .003) and IMA-E group (OR, 4.19; 95% CIs, 1.38-12.67; P = .01). Surgical conversion and secondary rupture were seen only in 1 patient without any aneurysm-related mortality. Percent sac shrinkage from the baseline was significantly promoted in the IMA+LA group (NO-E, 12.1% ± 16.6%; IMA-E, 11.4% ± 16.7%; IMA+LA-E, 18.0% ± 18.8%; P = .047). Fluoroscopy time was significantly longer in the IMA+LA-E group (NO-E, 60.2 ± 47.4 minutes; IMA-E, 59.3 ± 39.5 minutes; IMA+LA-E, 75.5 ± 42.8 minutes; P < .0001), and so do the dose-area product (NO-E, 424.6 ± 333.4 Gy cm2; IMA-E, 477.7 ± 342.4 Gy cm2; IMA+LA-E, 631.8 ± 449.1 Gy cm2; P < .0001). No embolization-related complications or radiation-related adverse events were recorded. CONCLUSIONS: Pre-emptive embolization of IMA, LAs, and median sacral artery at the time of EVAR reduced the incidences of pT2EL and any reintervention and promoted sac shrinkage during the follow-up period of 3 years.

Two-Stage Endovascular Aneurysm Repair with Preemptive Embolization: A Retrospective Study.

BACKGROUND: Type II endoleak is the most common complication of endovascular aneurysm repair. Retrograde perfusion from the aneurysmal sac side branch to the aneurysmal sac, including the inferior mesenteric artery and lumbar arteries, is associated with adverse events after endovascular aneurysm repair, such as aneurysm sac enlargement, reintervention, rupture, and abdominal aortic aneurysm-related death. Preemptive embolization of the aneurysmal sac side branch before endovascular aneurysm repair is an effective and safe procedure for preventing type II endoleak and reducing the size of the aneurysmal sac. Since 2019, we have been conducting preemptive embolization of the inferior mesenteric artery and lumbar arteries. Thus, we intended to work on a two-stage endovascular aneurysm repair in which embolization and endovascular aneurysm repair are performed on separate days, owing to concerns about prolonged operative time and increased contrast media use and radiation exposure from performing endovascular aneurysm repair simultaneously. This study aimed to evaluate the effects of a two-stage endovascular aneurysm repair. METHODS: This retrospective study included 114 cases of endovascular aneurysm repair (95 men and 19 women) for AAA performed at our hospital between January 2019 and December 2022. Inferior mesenteric artery and lumbar artery embolization were performed simultaneously with endovascular aneurysm repair (simultaneous group) in 49 cases, and two-stage embolization was performed (two-stage group) in 30 cases. The primary endpoints included the occurrence of T2EL during follow-up and the embolization rate of the IMA or LAs. RESULTS: Type II endoleak did not occur in the two-stage group (follow-up period: 35 ± 6.2 months), whereas it was observed in 8.2% of patients more than 6 months after EVAR in the simultaneous group (follow-up period: 28 ± 5.5 months). While the total operative time was 340 ± 111.2 min in the simultaneous group, the durations for embolization and endovascular aneurysm repair in the two-stage group were 169 ± 35.5 min and 135.0 ± 26.4 min (total time 304 ± 31.2 min, P = 0.21), respectively, indicating a reduction in the total time required for the 2 techniques. The total amounts of contrast media used in the simultaneous and two-stage groups were 200.0 ± 179.2 mL and 182.0 ± 51.2 mL (P = 0.42), respectively, and the corresponding total radiation doses were 2502.4 ± 690.5 mGy and 2114.6 ± 351.2 mGy (P = 0.28), respectively, showing a decrease in both in the two-stage group. The lumbar artery embolization rates were 74.3% and 87.9% (P < 0.01) in the simultaneous and two-stage groups, respectively, indicating a significant difference. CONCLUSIONS: Two-stage endovascular aneurysm repair with preemptive embolization of the inferior mesenteric artery and lumbar arteries may be an effective strategy for reducing type II endoleak occurrence, overall operative time, contrast use, and overall radiation exposure.

Stereolithographic (SLA) 3D Printing for Preprocedural Planning in Endovascular Aortic Repair of a Thoracic Aneurysm.

BACKGROUND: When treating aortic aneurysm patients with complex anatomical features, preprocedural planning aided by 3D-printed models offers valuable insights for endovascular intervention. This study highlights the use of stereolithographic (SLA) 3D printing to fabricate a phantom of a challenging aortic arch aneurysm with a complex neck anatomy. CLINICAL CASE: A 75-year-old female presented with a 58 mm descending thoracic aortic aneurysm (TAA) extending to the distal arch, involving the left subclavian artery (LSA) and the left common carotid artery (LCCA). The computed tomography (CT) scans underwent scrutiny by radiology and vascular teams. Nevertheless, the precise spatial relationships of the ostial origins proved to be challenging to ascertain. To address this, a patient-specific phantom of the aortic arch was fabricated utilizing an SLA printer and a biomedical resin. The thoracic endovascular aortic repair (TEVAR) procedure was simulated using fluoroscopy on the phantom to enhance procedural preparedness. Subsequently, the patient underwent a right carotid-left carotid bypass and a right carotid-left subclavian bypass. After a 24-hour interval, the patient underwent the TEVAR procedure, during which a 37 mm × 150 mm stent graft (CTAG, WL Gore and Associates, Flagstaff, AZ, USA) and a 40 mm × 200 mm stent graft (CTAG, WL Gore and Associates, Flagstaff, AZ, USA) were deployed, effectively covering the LSA and LCCA. Notably, the aneurysm exhibited complete sealing, with no indications of endoleaks or graft infoldings. At the 12-month follow-up, the patient remains in good health, with no evidence of endoleaks or any other surgery-related complication. CONCLUSION: This report showcases the successful use of a 3D-printed endovascular phantom in guiding the decision-making process during the preparation for a TEVAR procedure. The simulation played a pivotal role in selecting the appropriate stent graft, ensuring an intervention protocol optimized based on the patient-specific anatomy.

Fate of primary determinate and indeterminate target vessel endoleaks after fenestrated-branched endovascular aortic repair.

OBJECTIVE: The aim of this study was to investigate the outcomes of primary determinate and indeterminate target vessel endoleaks (TVELs) after fenestrated-branched endovascular aortic repair (F-BEVAR). METHODS: We conducted a single-center retrospective study (2014-2023) on F-BEVAR for thoracoabdominal (TAAAs) or pararenal aortic aneurysms (PRAAs). TVELs were classified as "primary" if present at the first postoperative computed tomography angiogram. Endoleaks were defined "determinate" (dELs) if the cause (type Ic or IIIc) and implicated target vessel were identifiable and "indeterminate" (iELs) if contrast enhancement was detectable at the level of fenestrations/branches without any evident source. Endoleaks involving multiple inflows (type II and target vessels) were defined as "complex" (cELs). Endpoints were endoleak spontaneous resolution, 1-year aneurysm sac failure to regress (>5 mm diameter decrease), and 4-year endoleak-related secondary interventions. Kaplan-Meier estimates and Cox regression were used for the analysis. RESULTS: There were 142 patients with JRAAs/PRAAs (n = 85; 60%) or TAAAs (n = 57; 40%), with 513 target arteries incorporated through a fenestration (n = 294; 57%) or directional branch (n = 219; 43%). Fifty-nine primary TVELs (12%) were identified in 35 patients (25%), a dEL in 20 patients (14%) and iEL in 15 (11%); 22 (15%) had a determinate or indeterminate cEL. Overall spontaneous resolution rate was 75% (95% confidence interval [CI], 51%-87%) at 4 years. cELs (odds ratio [OR], 5.00; 95% CI, 1.10-49.4; P < .001) and iELs after BEVAR (OR, 9.43; 95% CI, 3.41-56.4; P = .002) were more likely to persist >6 months, and persistent forms were associated with sac failure to regress at 1 year (OR, 1.72; 95% CI, 1.03-12.59; P = .040). Overall freedom from endoleak-related reinterventions was 85% (95% CI, 79%-92%) at 4 years, 92% (95% CI, 87%-97%) for those without primary TVELs and 62% (95% CI, 46%-84%) for those with any primary TVEL (P < .001). In particular, cELs (hazard ratio, 1.94; 95% CI, 1.4-18.81; P = .020) were associated with an increased need for reintervention. In case a secondary intervention was needed, iEL or cEL had an increased risk for multiple secondary procedures (hazard ratio, 2.67; 95% CI, 1.22-10.34; P = .034). CONCLUSIONS: Primary TVELs are frequent after F-BEVAR, and a clear characterization of the endoleak source by computed tomography angiogram is not possible in 40% of patients. Most primary TVELs spontaneously resolve, but during follow-up, patients with any primary TVEL experience a worsened freedom from endoleak-related reinterventions that is mostly driven by persistence of cELs and post-BEVAR iELs. Multiple secondary procedures may be required in case of iELs or cELs.

A Single-Institution Case Series of Total Endovascular Relining for Type 3 Endoleaks in Traditional Endovascular Aneurysm Repair (EVAR) Grafts with Raised Bifurcations.

BACKGROUND: The endovascular repair of infrarenal abdominal aortic aneurysms can be performed with a wide variety of devices. Many of these grafts elevate the aortic bifurcation which can limit future repairs if the graft material fails thereby creating a type III endoleak to aorto-uniliac grafts. Many manufacturers have grafts susceptible to this, but we have seen this in the Medtronic AneuRx graft. Our goal is to provide technical details and outcomes regarding a novel technique to reline these grafts while maintaining inline flow to the iliac arteries. METHODS: This was a single-institution review of patients who had endoleaks requiring intervention after a previously placed graft with an elevated aortic bifurcation. Primary outcomes included technical success defined as placement of all planned devices, resolution of type III endoleak, aneurysm size at follow-up, and requirement of reintervention. Secondary outcomes included 30-day complications, aneurysm-related mortality, and all-cause mortality. Technical details of the operation include back-table deployment of an Ovation device, modification of the deployment system tether and pre-emptive placement of an up and over 0.014″ wire. The wire is placed up and over and hung outside the contralateral gate. Once the main body is introduced above the old graft, the 0.014" is snared from the contralateral side and externalized. The main body is then able to be seated at the bifurcation as the limb is not fully deployed and then device deployment is completed per instructions for use. RESULTS: Our study consists of 4 individuals, 3 of which had an abdominal aortic aneurysm initially managed with an AneuRx endovascular aneurysm repair and 1 with a combination of Gore and Cook grafts. All 4 patients were male with an average age of 84.5 years at time of reline. All patients had at least 10 years between initial surgery and reline at our institution. Primary outcomes revealed no type 1 or 3 endoleaks at follow-up, technical success was 100% and 1 patient required reintervention for aneurysm growth and type 2 endoleak. In terms of our secondary outcomes, there was 1 postoperative complication which was cardiac dysfunction secondary to demand ischemia, aneurysm-related mortality was 0% and all-cause mortality was 25% at average follow-up of 2.44 years. CONCLUSIONS: As individuals continue to age, there are more patients who would benefit from less invasive reinterventions following endovascular aneurysm repair. Whether this is due to aortic degeneration, stent migration, or stent material damage is not always known. In this study, we present an endovascular approach to treating type III endoleak patients with a previous graft and elevated aortic bifurcation using Ovation stent grafts and found no evidence of type 1 or 3 endoleaks on follow-up imaging. This approach may allow patients with type III endoleak the option of a minimally invasive, percutaneous approach where they previously would not have had one.

Systematic review and meta-analysis of outcomes after semi-conversion with graft preservation for failed endovascular aneurysm repair.

OBJECTIVE: The aim of this study was to evaluate the outcomes after semi-conversion (open conversion with graft preservation) after failed endovascular aneurysm repair (EVAR). The primary outcomes were 30-day mortality and semi-conversion failure. Secondary outcomes were 30-day major systemic complications, endoleak recurrence, reinterventions, and overall survival. METHODS: The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The protocol was prospectively registered on PROSPERO (CRD42023421153). All studies reporting the outcomes of semi-conversions for failed EVAR were eligible for inclusion. Quality assessment was performed using the Methodological Index for Non-Randomized Studies (MINORS) tool. A random effects meta-regression of proportions was conducted using the double arcsine-Tukey transformation, given the frequent zero event rate in the primary outcome. Heterogeneity was assessed with the I2 statistic. RESULTS: Eight studies were included in the review after full text screening. A total of 196 patients underwent semi-conversion at a mean time from EVAR of 47.4 months, 68.9% in an elective setting. Mean age at conversion was 78.1 years, and the main indication was isolated endoleak type II (70.1% of cases). Aortic clamping was not necessary in 92.3% of semi-conversions; the aortic sac was opened in 96.1% of cases; in 93.3% of cases, ligation/suture of one or more culprit arteries were performed; and aortic neck banding was executed in 29.2%. At 30 days from surgery, the pooled mortality and the major systemic complications rates were 5.3% (I2 = 24.9%) and 13.4% (I2 = 54.3%), respectively. At follow-up, endoleak recurred after 12.6% semi-conversions (I2 = 83.2%), and the rate of reinterventions was 7% (I2 = 50.1%); the semi-conversion failure rate was 5.5% (I2 = 54.1%), and the overall survival was 84.6% (I2 = 33.3%). CONCLUSIONS: Semi-conversions have acceptable 30-day mortality rates, but the early and mid-term risks of complications, reinterventions, ruptures, and infections are not negligible. This procedure might be an alternative to complete or partial graft explant in patients whom aortic cross-clamping is not ideal.

One-Year Results of a Low-Profile Endograft in Acute, Complicated Type B Aortic Dissection.

BACKGROUND: The safety and effectiveness of the RelayPro endograft (Terumo Aortic) was assessed for the treatment of acute, complicated type B aortic dissection (TBAD). METHODS: A prospective pivotal trial analyzed a primary end point of all-cause mortality at 30 days. Secondary end points included technical success, major adverse events (disabling stroke, renal failure, and paraplegia/paralysis), endoleaks, patency, rupture, device integrity, false lumen perfusion, reinterventions, aortic expansion, and migration evaluated to 5 years. RESULTS: The study involved 22 United States centers and enrolled 56 patients (mean age, 59.5 ± 11.4 years) from 2017 to 2021; of whom, 73.2% were men and 53.6% were African American. TBAD was complicated by malperfusion of the kidneys (51.8%), lower extremities (35.7%), and viscera (33.9%), and rupture (10.7%). Dissection extended proximally to zones 1/2 (14.3%) and zone 3 (78.6%) and distally to the iliac arteries (67.3%). Most procedures were percutaneous (85.5%). Technical success was 100%. Median hospitalization was 7 days (interquartile range, 5-12 days). All-cause mortality at 30 days was 1.8% (1 of 56; upper 95% CI, 8.2%; P < .0001). Seven major adverse events occurred in 6 patients (10.7%), consisting of paraplegia (n = 3), paraparesis (n = 2), disabling stroke (n = 1), and renal failure (n = 1). All paraplegia/paraparesis resolved with lumbar drainage. Kaplan-Meier analysis estimated a freedom from major adverse events of 89.1% at each interval from 30 days to 3 years. There was 1 endoleak (Type Ia), 2 retrograde dissections, and aortic diameter growth occurred in 2. There has been no rupture, fistula, component separation, patency loss, stenosis, kinking, twisting, bird beak, loss of device integrity, or fracture. CONCLUSIONS: RelayPro is safe and effective in acute, complicated TBAD. Follow-up is ongoing to evaluate longer-term outcomes and durability.

Prevalence of type II endoleak after elective endovascular aneurysm repair with polytetrafluoroethylene- or polyester-based endografts.

OBJECTIVE: Type II endoleak is the most frequent complication after endovascular abdominal aneurysm repair. Polytetrafluoroethylene and polyester (PE) are the two most commonly used graft materials in endovascular aneurysm repair (EVAR) devices. Biological properties of the material might influence the appearance and persistence of type II endoleak (T2EL). Therefore, the aim of this study was to evaluate potential differences in the prevalence of T2EL after EVAR between polytetrafluoroethylene (PTFE) and PE endografts in patients electively treated for an infrarenal abdominal aortic aneurysm. METHODS: A single-center, retrospective, observational study was conducted between January 2011 and January 2022. Preoperative, procedural, and follow-up data were derived from electronic health records. Imaging included computed tomography scans, and/or duplex ultrasound examination. The primary end point was the prevalence of T2EL diagnosed within 1 year after EVAR. Secondary end points included the prevalence of T2EL throughout follow-up, early (≤30 days) and late (>30 days) T2EL, the rate of T2EL disappearance during the follow-up period, the prevalence of type I and III endoleak, and T2EL-related reinterventions. RESULTS: Follow-up was available for 394 patients, 245 in the PE and 149 in the PTFE group. The prevalence of T2EL diagnosed within 1 year after endovascular repair was 11.8% in the PE group and 21.5% in the PTFE group (P = .010). There was no significant difference in early (≤30 days) and late (>30 days) T2EL between groups (P = .270 and P = .311). There was no difference in the freedom from endoleak type II reinterventions between groups (P = .877). CONCLUSIONS: The prevalence of T2EL after elective EVAR is significantly higher with the use of PTFE-based endografts compared with PE-based endografts. This difference is mostly based on T2EL diagnosed after 30 days of follow-up.