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.

[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.

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.

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.

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.

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.

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.

Endovascular aortic repair with sac embolization for the prevention of type II endoleaks (the EVAR-SE study): study protocol for a randomized controlled multicentre study in Germany.

BACKGROUND: Beyond a certain threshold diameter, abdominal aortic aneurysms (AAA) are to be treated by open surgical or endovascular aortic aneurysm repair (EVAR). In a quarter of patients who undergo EVAR, inversion of blood flow in the inferior mesenteric artery or lumbar arteries may lead to type II endoleak (T2EL), which is associated with complications (e.g. AAA growth, secondary type I endoleak, rupture). As secondary interventions to treat T2EL often fail and may be highly invasive, prevention of T2EL is desirable. The present study aims to assess the efficacy of sac embolization (SE) with metal coils during EVAR to prevent T2EL in patients at high risk. METHODS: Over a 24-month recruitment period, a total of 100 patients undergoing EVAR in four vascular centres (i.e. Klinikum rechts der Isar of the Technical University of Munich, University Hospital Augsburg, University Hospital Dresden, St. Joseph's Hospital Wiesbaden) are to be included in the present study. Patients at high risk for T2EL (i.e. ≥ 5 efferent vessels covered by endograft or aneurysmal thrombus volume <40%) are randomized to one group receiving standard EVAR and another group receiving EVAR with SE. Follow-up assessments postoperatively, after 30 days, and 6 months involve contrast-enhanced ultrasound scans (CEUS) and after 12 months an additional computed tomography angiography (CTA) scan. The presence of T2EL detected by CEUS or CTA after 12 months is the primary endpoint. Secondary endpoints comprise quality of life (quantified by the SF-36 questionnaire), reintervention rate, occurrence of type I/III endoleak, aortic rupture, death, alteration of aneurysm volume, or diameter. Standardized evaluation of CTA scans happens through a core lab. The study will be terminated after the final follow-up visit of the ultimate patient. DISCUSSION: Although preexisting studies repeatedly indicated a beneficial effect of SE on T2EL rates after EVAR, patient relevant outcomes have not been assessed until now. The present study is the first randomized controlled multicentre study to assess the impact of SE on quality of life. Further unique features include employment of easily assessable high-risk criteria, a contemporary follow-up protocol, and approval to use any commercially available coil material. Overcoming limitations of previous studies might help SE to be implemented in daily practice and to enhance patient safety. TRIAL REGISTRATION: ClinicalTrials.gov NCT05665101. Registered on 23 December 2022.

CIRSE Standards of Practice on Management of Endoleaks Following Endovascular Aneurysm Repair.

BACKGROUND: Endoleaks represent the most common complication after EVAR. Some types are associated with ongoing risk of aneurysm rupture and necessitate long-term surveillance and secondary interventions. PURPOSE: This document, as with all CIRSE Standards of Practice documents, will recommend a reasonable approach to best practices of managing endoleaks. This will include imaging diagnosis, surveillance, indications for intervention, endovascular treatments and their outcomes. Our purpose is to provide recommendations based on up-to-date evidence, updating the guidelines previously published on this topic in 2013. METHODS: The writing group was established by the CIRSE Standards of Practice Committee and consisted of clinicians with internationally recognised expertise in endoleak management. The writing group reviewed the existing literature performing a pragmatic evidence search using PubMed to select publications in English and relating to human subjects up to 2023. The final recommendations were formulated through consensus. RESULTS: Endoleaks may compromise durability of the aortic repair, and long-term imaging surveillance is necessary for early detection and correct classification to guide potential re-intervention. The majority of endoleaks that require treatment can be managed using endovascular techniques. This Standards of Practice document provides up-to-date recommendations for the safe management of endoleaks.

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.

Image Guidance Techniques and Treatment Approach Optimization in the Management of Type-II Endoleak After Endovascular Aortic Aneurysm Repair.

BACKGROUND: Over the past 3 decades endovascular aortic aneurysm repair emerged as the primary approach for abdominal aortic aneurysm management, however the occurrence of endoleak following endograft implantation imposes a high toll on patients and hospitals alike. The early diagnosis and appropriate treatment of endoleaks is associated with better outcomes, which calls for more advanced imaging and a standardized approach for endoleak diagnosis and management following endovascular aortic aneurysm repair. Although conventional strategy with non-targeted deployment of coils and embolic material in the aneurysm sac is considered to be the standard approach in many hospitals, it may not prove to be a viable option, given that it affects any further follow-up imaging in the event of sub-optimal therapy and consequent recurrence. METHODS: Based on our tertiary aortic referral center experience we summarize and describe strategies for optimal selection of various treatment approaches for Type-II Endoleak management including endovascular, percutaneous and laparoscopic approaches with particular focus on intraoperative image guidance techniques. RESULTS: After failed conventional endovascular embolization attempt we recommend specific complex type II endoleak management approaches based on the location of the endoleak within the aneurysm sac along the x, y and z axis. A transabdominal or laparoscopic approach enable treatment in endoleaks located in the anterior portion of the sac. Endoleaks in the posterior portion of the sac could be treated using the transcaval or the translumbar approach, depending on whether the endoleak is situated on the left or the right side. Alternative strategies should be considered if patient anatomy does not allow for either transcaval or translumbar approach. The transgraft technique is reserved for endoleaks located in the cranial portion of the sac, while the perigraft approach could present a means of treatment for endoleaks situated in the caudal portion of the aneurysm sac. CONCLUSION: We encourage establishing a patient specific treatment plan in accordance with individual anatomy based on cross sectional imaging modality (time resolved dynamic imaging in selected cases) and intraoperative image guidance to provide a safe and accurate endoleak localization and embolization for patients undergoing type II endoleak treatment.

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.

Reducing aneurysm sac growth and secondary interventions following endovascular abdominal aortic aneurysm repair by preemptive coil embolization of the inferior mesenteric artery and lumbar arteries.

OBJECTIVE: Type II endoleak (EL-2) is the most common complication following endovascular aneurysm repair (EVAR), leading to continued sac growth and potential rupture. In this study, we examined the association between patency of the inferior mesenteric artery (IMA) and lumbar arteries (LAs) with respect to sac growth. The effect of preemptive embolization of the IMA and/or LAs on the need for secondary interventions for sac growth post-EVAR was also evaluated. METHODS: A retrospective cohort study was performed on consecutive patients who underwent EVAR for non-ruptured, infrarenal abdominal aortic aneurysms (AAAs) from January 2012 to December 2020. A select group of patients underwent preemptive embolization of the IMA and/or LA. Patients with any types I, III, or IV endoleaks were excluded. Patency of the IMA and LA on preoperative computed tomography angiogram (CTA) was evaluated on TeraRecon workstation. All secondary interventions to treat EL-2 were recorded. Sac growth was defined as centerline axial diameter increase of ≥5 mm on follow-up CTA. RESULTS: A total of 300 patients (mean age, 74 ± 8.5 years; 83.7% male) underwent EVAR. Ninety-nine patients had preemptive embolization of the IMA and/or LA. Mean follow-up of the cohort was 59.3 ± 30.5 months. Thirty-six patients (12%) demonstrated sac growth on follow-up; 12 of these (33.3%) had preemptive embolization. The median time until detection of sac growth was 28.8 months (interquartile range, 15.2-46.5 months), with a mean growth of 10.1 ± 6.4 mm. Sac growth was significantly associated with presence of EL-2: 27 of 36 (75%) with EL-2 vs 9 of 36 (25%) without EL-2 (P < .001). Patients with sac growth had a higher mean total number (2.6 ± 1.5) of patent lower LAs (L3, L4) compared with those without (2.0 ± 1.4; P = .03). Patency of L1, L2, and L3 LAs were not associated with sac growth. However, patency of at least one L4 LA was significantly associated with sac growth (14.8% vs 7.7%; P = .04). The highest incidence of sac growth (17.6%) was seen when both IMA and L4 LA were patent; significantly different from the lowest incidence (5.3%) when both were occluded preoperatively (P = .018). Preemptive coiling of the IMA and/or LA significantly reduced the need for post-EVAR secondary intervention for sac growth. Freedom from post-EVAR secondary intervention was achieved in 92 of 99 (92.9%) pre-EVAR coiled patients vs 163 of 201 (81.5%) patients who did not undergo pre-EVAR coiling (P = .009). CONCLUSIONS: Preemptive coil embolization of the IMA and LAs, especially L4 LA, reduces the need for secondary interventions for sac growth, potentially improving the long-term durability of EVAR.

Long-Term Outcomes of Simple Endovascular Aneurysm Repair Based on the Initial Aortic Diameter.

PURPOSE: We aimed to investigate the effects of initial abdominal aortic aneurysm (AAA) diameter on aneurysmal sac expansion/shrinkage, endoleaks, and reintervention postelective simple endovascular aneurysm repair (EVAR). METHODS: Overall, 228 patients monitored for >1 year after EVAR were analyzed. Male and female participants with initial AAA diameters <55 mm and <50 mm, respectively, composed the small group (group S), while those with initial AAA diameters ≥55 mm (men) and ≥50 mm (women) composed the large group (group L). Aneurysmal sac expansion of 10 mm and/or reintervention during follow-up (composite event) and its related factors were evaluated. RESULTS: The 5-year freedom from composite event rate was significantly higher in group S (92.4 ± 2.8%) than that in group L (79.1 ± 4.9%; P <0.01). Multivariate analysis revealed AAA diameters before EVAR in group S (hazard ratio, 0.38; 95% confidence interval, 0.18-0.81; P = 0.01) and type II endoleak (T2EL) at discharge (hazard ratio, 2.83; 95% confidence interval, 1.29-6.20; P <0.01) as factors associated with the composite event. The freedom from composite event rate decreased to 51 ± 13% at 5 years in group L with T2EL. CONCLUSIONS: Group S had high freedom from composite event rate; in group L, the rate decreased to 51% at 5 years with T2EL at discharge.

Ultrasound Surveillance is Feasible After Endovascular Aneurysm Repair.

BACKGROUND: Surveillance after endovascular aneurysm repair (EVAR) is traditionally done with computed tomography angiography (CTA) scans that exposes patient to radiation, nephrotoxic contrast media, and potentially increased risk for cancer. Ultrasound (US) is less labor intensive and expensive and might thus provide a good alternative for CTA surveillance. The aim of this study was to evaluate in real-life patient cohorts whether US is able to detect post-EVAR aneurysm-related complications similarly to CTA. METHODS: This retrospective study compared the outcome of consecutive patients who underwent EVAR for intact abdominal aortic aneurysm and were surveilled solely by CTA (CTA-only cohort, n = 168) in 2000-2010 or by combined CTA and US (CTA/US cohort, n = 300) in 2011-2016, as a standard surveillance protocol in the department of vascular surgery, Helsinki University Hospital. The CTA-only patients were imaged at 1, 3, and 12 months and annually thereafter. The CTA/US patients were imaged with CTA at 3 and 12 months, US at 6 months and annually thereafter. If there were suspicion of >5 mm aneurysm growth, CTA scan was performed. The patients were reviewed for imaging data, reinterventions, aneurysm ruptures, and death until December 2018. The 2 groups were compared for secondary rupture, aneurysm-related and cancer-related death, reintervention related to abdominal aortic aneurysm, and maximum aneurysm diameter increase ≥5 mm. The mean follow-up in the CTA-only cohort was 67 months and in CTA/US cohort 43 months. RESULTS: The 2 cohorts were alike for basic characteristics and for the mean aneurysm diameter. The total number of CT scans for detecting aneurysm was 84.1/100 patient years in the CTA-only cohort compared to 74.5/100 patient years for US/CTA cohort. Forty percent of patients under combined CTA/US surveillance received 1 or more additional CTA scans. The 2 cohorts did not differ for 1-year, 5-year and 8-year freedom from aneurysm related death, secondary sac rupture, nor the incidence of rupture preventing interventions. CONCLUSIONS: Based on the follow-up data of this real-life cohort of 468 patients, combined surveillance with US and additional CTA either per protocol or due to suspicion of aneurysm-related complications had comparable outcome with sole CTA-surveillance. Thus, US can be considered a reasonable alternative for the CTA. However, our study showed also that the need of additional CTAs due to suspicion of endoleak or aneurysm nonrelated reasons is substantial.

Iliac tortuosity increases reinterventions but not adverse outcomes following repair of juxtarenal aneurysms using physician-modified endografts.

OBJECTIVE: Increased angulation of the proximal aortic neck has been associated with complications following endovascular repair of infrarenal aortic aneurysms, including increased incidence of endoleaks, stent migration, secondary interventions, and conversions. However, knowledge on the impact of aortoiliac tortuosity on outcomes following fenestrated repair remains limited. This study aims to quantify the effect of aortoiliac tortuosity on outcomes following fenestrated repair. METHODS: A single-center, retrospective review of all patients who underwent a physician-modified endovascular repair for the treatment of juxtarenal aortic aneurysms under a single physician-sponsored investigation device exemption study from 2011 to 2021 was performed. Center luminal lines and geometric distances were obtained using TeraRecon software (San Mateo, CA). A tortuosity index was calculated (tortuosity index = centerline distance/geometric line distance) for each iliac vessel as well as for the infrarenal aorta according to Society for Vascular Surgery reporting standards. Aortic and iliac tortuosity were assessed independently and stratified as low and high. Demographics, comorbidities, anatomic and operative details, and outcomes were compared using univariable and multivariable analysis. RESULTS: A total of 135 patients were identified. Thirty-eight patients (28%) had high aortic tortuosity, and 55 patients (42%) had high iliac tortuosity. Patients with high tortuosity were older (aortic: 78 vs 76 years; P = .04; iliac: 78 vs 75 years; P = .01) and differed by sex. Twenty-two percent of men and 50% of women had high aortic tortuosity (P = .01). Forty-seven percent of men and 20% of women had high iliac tortuosity (P = .01). There were no differences in comorbidities based on aortic tortuosity, but coronary artery disease (high: 58% vs low: 36%; P = .01) and hypertension (high: 69% vs low: 86%; P = .02) differed based on iliac tortuosity. Aneurysm diameter was larger for patients with high iliac tortuosity (72 mm vs 64 mm; P < .01), and fluoroscopy time was longer for patients with high aortic tortuosity (41 vs 31 minutes; P = .02). When outcomes were assessed, high iliac tortuosity was associated with increased rate of reinterventions (hazard ratio, 2.6; 95% confidence interval, 1.2-6.0) and type 1 or 3 endoleak (hazard ratio, 5.2; 95% confidence interval, 1.7-16); however, all other outcomes were similar. CONCLUSIONS: Among patients treated with physician-modified endovascular repair for juxtarenal aneurysms, iliac tortuosity but not aortic tortuosity, is associated with increased reinterventions and type 1 or type 3 endoleaks. Long-term follow-up is critical for patients with high iliac tortuosity to ensure that high-risk endoleaks are identified and treated early to avoid the risk of rupture.

Intra-Sac Injection of Thrombin During Endovascular Aneurysm Repair to Remedy Type II Endoleak and Promote Sac Shrinkage.

PURPOSE: To evaluate the safety and effectiveness of intra-sac thrombin injection to remedy type II endoleaks (T2ELs) during endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: 224 cases abdominal aortic aneurysm (AAA) were treated with EVAR. For the 52 cases of intra-operative type II endoleaks and 8 cases of ruptured AAAs, after the grafts were deployed, thrombin was injected into the aneurysm sac through a preset catheter. The occurrence of endoleaks post-EVAR were followed up with by Computed Tomography (CT) angiogram. The diameter and the volume of the aneurysm sac were also measured. Endpoints included incidence of T2ELs, AAA sac shrinkage and re-intervention rate and all-cause mortality. RESULTS: The overall technical success rate was 100%. Fifty-two patients were followed up with for 9-56 (median 24) months. No serious complications were observed during follow-up. The incidence of endoleak was 5.8% (3/52) during follow-up. The maximum diameter of the aneurysm decreased from 61.1 ± 14.2 mm to 53.7 ± 10.6 mm, 47.9 ± 8.3 mm and 43.7 ± 7.2 mm (87.9%, 78.4% and 71.5% of pre-EVAR) at the 6-month, 1-year and 2-year follow-up, respectively (P < .05). The volume of the aneurysm sac shrank from 236.2 ± 136.2 cm3 to 202.6 ± 114.1 cm3, 155.6 ± 68.4 cm3 and 129.7 ± 52.4 cm3 (85.8%, 65.9%, and 54.9% of pre-EVAR) at the 6-month, 1-year and 2-year follow-up, respectively (P < .05). The rate of various endoleaks was 5.8% (3/52) and the re-intervention rate was 1.9% (1/52) in this research. CONCLUSIONS: Clinical outcomes show that intra-sac injection of thrombin during EVAR is safe and may be effective in remedying small amount and low-velocity endoleaks and promoting shrinkage of the aneurysm sac.

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.