A Prevention Protocol Reduces Spinal Cord Ischemia in Patients Undergoing Branched/Fenestrated Endovascular Aortic Repair.

OBJECTIVES: Spinal cord ischemia (SCI) is a devastating complication that is associated with thoracoabdominal aortic repair, with higher risk associated with increased aortic coverage length, making patients undergoing branched/fenestrated endovascular repair(B/FEVAR) particularly vulnerable. A bundled SCI prevention protocol was previously reported to reduce SCI rates when compared to a historic cohort in a single-center study. Therefore, this analysis aims to further validate and update outcomes associated with the protocol given the routine implementation of this strategy at two institutions (University of Florida [UF] and the University of Alabama at Birmingham [UAB]) since inception. METHODS: Components of the SCI prevention protocol include selective cerebrospinal fluid (CSF) drainage, specified blood pressure parameters, transfusion goals, and selective pharmacologic adjuncts (naloxone, steroids). This protocol was routinely implemented in May 2015. Patients undergoing B/FEVAR from May 2015-December 2022 constituted the post-protocol cohort(n=402) and were compared to the pre-protocol cohort (n=160, January 2010-April 2015). The primary outcome was SCI incidence and subgroup analysis was conducted among patients deemed to be high-risk (Crawford extent I- III thoracoabdominal aneurysms (TAAA) dissection-related disease, prior aortic repair, coverage proximal to zone 5). Survival analysis was performed using Kaplan-Meier methodology. RESULTS: The pre- and post-protocol cohorts were demographically similar, though more post-protocol patients were American Society of Anesthesiology(ASA) class IV (86.1% vs. 55.0%; p<0.001). TAAA was the most common indication in both groups. CSF drain placement was more common in the post-protocol group, particularly among high-risk patients. SCI occurred in 15.9% of pre-protocol patients versus 3.0% of post-protocol patients(p<0.001). In high-risk patients, the pre- and post-protocol cohort SCI incidence was 23.2% vs. 5.0%, respectively (p<0.001). 30-day mortality was decreased in the post-protocol cohort (6.3% vs. 2.2%, p=0.02). Although the post-protocol group had a trend toward improved 1-year survival, this was not statistically significant (84.4% vs. 88.3%, log-rank p=0.35). Among SCI patients, one-year mortality was 28% and 33.3% in the pre- and post-protocol groups, respectively(p=0.46). CONCLUSION: Implementation of a bundled SCI prevention protocol significantly reduces SCI rates in B/FEVAR patients, which has now been validated at two institutions, with the most significant reductions occurring among high-risk patients. Although the overall one-year mortality difference was not significantly different between the cohorts, the high mortality rates among SCI patients highlights the importance of preventative measures.

Modified Ex Vivo Renal Reconstruction to Facilitate Fenestrated-Branched Endovascular Repair of a Thoracoabdominal Aortic Aneurysm.

PURPOSE: To report the use of modified ex vivo renal artery (RA) reconstruction in a patient with 2 small right RAs (RRAs) in anticipation of planned fenestrated-branched endovascular aortic repair (FB-EVAR) of thoracoabdominal aortic aneurysm (TAAA). CASE REPORT: A staged hybrid repair was utilized in a patient with Extent II TAAA involving celiac axis (CA), superior mesenteric artery (SMA), single left RA (LRA), and 2 small (<3 mm) RRAs. The first-stage operation consisted of hepato-renal bypass using modified ex vivo renal reconstruction with single end-to-end anastomosis to both RAs using a saphenous vein graft. A second stage FB-EVAR was performed using patient-specific manufactured stent-graft with 3 fenestrations for the CA, SMA, and LRA 6 weeks later. The patient recovered with no complications. At 4 years, the patient had widely patent hepato-renal bypass and target vessels with normal renal function. CONCLUSION: The use of adjunctive hybrid procedures may optimize or facilitate FB-EVAR. In this patient, salvage of 2 small RAs was not ideally suited for branch stenting but was possible using modified ex vivo RA reconstruction with preservation of kidney parenchyma and function. CLINICAL IMPACT: This case report illustrates a hybrid approach to overcome one of the most frequent limitations to total endovascular incorporation of renal arteries, eg small diameter, early bifurcation and multiple vessels. The modified ex vivo technique allows meticulous renal artery reconstruction without the deleterious effect of warm ischemia and without the cumbersome reconstruction of ureter and vein that is needed with traditional on table ex vivo auto transplantation. The technique is used in a minority of cases and adds the morbidity of open approach. Case selection is of paramount importance.

A Scoping Review of Definitions of Success in Endovascular Aortic Arch Repair.

INTRODUCTION: The present standard of care to treat aortic arch pathologies is open surgical repair with cardiopulmonary bypass and deep hypothermic arrest. With approaches for total endovascular and extra-anatomic cervical debranching hybrid arch repair becoming more diverse, understanding what is considered a successful operation is prerequisite for a rigorous comparison of techniques. This review describes the specific outcomes reported, the rates of success, and the definitions of technical and clinical success in total endovascular and extra-anatomic cervical debranching hybrid aortic arch repair. METHODS: A comprehensive search of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials was performed. Studies with patients undergoing total endovascular or hybrid extra-anatomic cervical debranching repair of the aortic arch were included. Any publications including only patients with Ishimaru zone 2 or distal repairs were excluded from this review. Studies with less than 5 patients were excluded. Data extraction was performed by one author. Data items included were study design, procedure type, procedural details, underlying pathology, type of cervical debranching, type of endograft repair, surgical outcomes, definition of cerebrovascular events, technical success, and the definition of technical success. RESULTS: Of 1754 studies screened for review, 85 studies with 5521 patients were included. By frequency, the included studies examined the following interventions: fenestrated devices, branched devices, parallel grafting. Most studies were retrospective single-institution studies. There were no randomized controlled trials. Short-term mortality and cerebrovascular events were nearly universally reported, present in 99% and 95% of studies reviewed, respectively. Only 27% of studies provided an explicit definition for cerebrovascular events. While 75% of studies reported a technical success rate, only 45% of those studies provided explicit criteria. Clinical success rates were infrequently reported, present in only 5.9% of studies reviewed. CONCLUSION: The definitions of technical success that were provided fell short of analogous defined reporting standards in nearly all studies, inflating technical success rates. Definitions of cerebrovascular events and technical success require stringent criteria to uniformly compare various methods of endovascular aortic arch repair. A societal consensus document for reporting standards of endovascular aortic arch repair would allow for higher-quality outcomes research. CLINICAL IMPACT: Total endovascular and extra-anatomic cervical debranching hybrid operations are being increasingly utilized for complex aortic arch repair. These techniques, however, can be associated with serious complications. Currently, there is no accepted metric to define technical or report clinical outcomes. Due to the paucity of high-quality data, use of these approaches may be limited in clinical practice. This study emphasizes the need for the development of standards for reporting outcomes in endovascular aortic arch repair. Future studies can then utilize these benchmarks, whcih will allow for improved efficacy and safety in these techniques.

3 Year Outcomes of Off-the-shelf Gore Thoracoabdominal Multibranch Endoprosthesis and Physician-Modified Endografts for Complex Abdominal and Thoracoabdominal Aortic Aneurysms.

OBJECTIVE: Fenestrated-branched endovascular aortic repair (FB-EVAR) has shown favorable outcomes for repair of complex aneurysms and thoracoabdominal aortic aneurysms (TAAA). Physician-modified endografting (PMEG) and the Gore Thoracoabdominal Multibranch Endoprosthesis (TAMBE) provide custom and off-the-shelf devices for FB-EVAR, respectively. This study compares the outcomes of TAMBE and PMEG at a single institution. METHODS: A retrospective review of patients who underwent TAMBE as part of the multicenter pivotal trial or PMEG as part of a prospective physician sponsored investigational device exemption at a single institution between 2020-2022 were completed. Patient demographics, characteristics, perioperative and midterm outcomes were compared. RESULTS: A total of 68 patients were included, with 12 in the TAMBE group and 56 in the PMEG group. Baseline characteristics were comparable between groups. Aneurysm type was most often TAAA in both groups (58% TAMBE and 52% PMEG). TAMBE had a higher rate of upper extremity access (100% vs 63%, P=.013) and longer mean procedure time (247 ± 36 vs 189 ± 49 minutes, P<.001). Other intraoperative metrics were similar between groups. Technical success was 100% in TAMBE and 95% in PMEG (P=0.412). There was no 30-day mortality in either group. No major adverse events occurred with TAMBE, while in PMEG cases, 2% had respiratory failure, 2% required dialysis, and 4% experienced spinal cord ischemia. While overall endoleak rates were similar (50% of TAMBE vs 41% of PMEG, P=0.57), type II accounted for all of the endoleaks in the TAMBE group, while type I or III endoleaks were seen in 11% of PMEG patients. At the median follow-up of 26.7 months for the TAMBE group and 21.2 months for the PMEG group, target vessel instability was seen in 10.4% of TAMBE, and 6.9% of PMEG targeted branches (P=0.401). Reintervention was required in 33% of TAMBE patients and 27% of PMEG patients (P=.646). Estimated freedom from reintervention at 3 years were similar (56% TAMBE vs. 62% PMEG, log-rank P=0.910). Freedom from visceral renal target vessel instability at 3 years was 89% for both groups (log-rank P=0.459). Kaplan Meier 3-year estimated survival was 100% for patients in the TAMBE group and 77% for patients in the PMEG group (log-rank P=.157). CONCLUSIONS: At experienced centers, FB-EVAR can be completed with PMEG or TAMBE with comparable, excellent perioperative and midterm outcomes. Reinterventions are frequently needed for both TAMBE and PMEG.

Comparative Evaluation of the Short-Term Outcome of Different Endovascular Aortic Arch Procedures.

Objectives: There are several endovascular treatment options to treat aortic arch and thoracic aortic pathologies with custom-made or surgeon-modified aortic stent grafts. This study seeks to assess endovascular treatment methods for aortic arch and thoracic aortic pathologies with no acceptable proximal landing zone for standard thoracic endovascular aortic repair (TEVAR), comparing different treatment methods and evaluating technical success, intraoperative parameters and short-term outcomes. Methods: All patients undergoing elective or emergency endovascular treatment of aortic arch and thoracic aortic pathologies, with no acceptable landing zone for standard TEVAR, between 1 January 2010 and 31 March 2024, at the University Hospital Düsseldorf, Germany were included. An acceptable landing zone was defined as a minimum of 2 cm for sufficient sealing. All patients were not suitable for open surgery. Patients were categorized by an endovascular treatment method for a comprehensive comparison of pre-, intra- and postoperative variables. IBM SPSS29 was used for data analysis. Results: The patient cohort comprised 21 patients, predominantly males (81%), with an average age of 70.9 ± 9 years with no acceptable proximal landing zone for standard TEVAR procedure. The most treated aortic pathologies were penetrating aortic ulcers and chronic post-dissection aneurysms. Patients were sub-grouped according to the applied procedure as follows: five patients with chimney thoracic endovascular aortic repair (chTEVAR), seven patients with in situ fenestrated thoracic endovascular aortic repair (isfTEVAR), six patients with custom-made fenestrated thoracic endovascular aortic repair (cmfTEVAR) and three patients with custom-made branched thoracic endovascular aortic repair (cmbTEVAR). Emergency procedures involved two patients. There were significant differences in the total procedure and fluoroscopy time, as well as in contrast agent usage among the treatment groups. cmfTEVAR had the shortest total procedure time, while chTEVAR exhibited the highest contrast agent usage. The overall mortality rate among all procedures was 9.5% (two patients) and 4.7% for elective procedures, respectively. Deaths were associated with either retrograde type A dissection or stent graft infection. Both patients were treated with chTEVAR. There was one minor and one major stroke; these patients were treated with isfTEVAR. No endoleak occurred during any procedure. The reintervention rate for chTEVAR was 20% and 0% for all other procedures during the in-hospital stay. The patients who were treated with cmfTEVAR had no complications, the shortest operating and fluoroscopy time, and less contrast agent was needed in comparison with other treatment methods. Conclusions: Complex endovascular procedures of the aortic arch with custom-made or surgeon-modified aortic stent grafts offer a safe solution, with acceptable complication rates for patients who are not suitable for open aortic arch repair. In terms of procedure-related parameters and complication rates, a custom-made fenestrated TEVAR is potentially advantageous compared to the other endovascular techniques.

CO2 Angiography in the Standard and Complex Endovascular Repair of the Abdominal Aorta-A Narrative Review of the Literature.

Background/Objectives: Carbon dioxide digital-subtraction angiography (CO2-DSA) is an increasingly adopted technique in endovascular aortic repair (EVAR) and fenestrated/branched EVAR (F/B-EVAR); it is used to reduce the amount of iodinate contrast medium (ICM) and prevent postoperative renal function worsening (PO-RFW). Our aim is to report results from the literature on EVAR and F/B-EVAR procedures using CO2-DSA, together with wider applications in aortic endovascular treatment. Methods: We performed a literature review by searching electronic databases for published data on CO2-DSA during EVAR and F/B-EVAR procedures. The endpoints were postoperative renal function worsening (PO-RFW) and efficacy of intraoperative arterial visualization. Further, applications of CO2 for thoracic endovascular aortic repair (TEVAR) were described. Results: Seventeen studies reporting results on CO2-DSA in EVAR (644 patients) were retrieved. Overall, 372 (58%) procedures were performed with CO2 alone, and 272 (42%) were performed with CO2+ICM. Eight studies analyzed the effect of CO2-DSA angiography on PO-RFW; four studies showed a significantly lower rate of PO-RFW compared to ICM. Five studies (153 patients) analyzed intraoperative arterial visualization with CO2-DSA; renal and hypogastric arteries were effectively visualized in 69% and 99% of cases, respectively. The use of CO2-DSA in F/B-EVAR has not been widely investigated. The largest series reported that PO-RFW was lower in the CO2 vs. ICM group. Conclusions: Carbon dioxide is widely applied in modern aortic endovascular treatment. CO2-DSA for EVAR and F/B-EVAR is an efficient technique for reducing PO-RFW while allowing acceptable arterial intraoperative visualization.

Factors Affecting Compression of the Left Subclavian Artery Bridging Stent In Zone 2 Fenestrated Endovascular Arch Repair.

INTRODUCTION: Left subclavian artery (LSA) preservation during thoracic endovascular aortic repair (TEVAR) has been related to low morbidity. This study investigated the incidence of LSA stent compression in patients managed with fenestrated endovascular arch repair (f-Arch) and evaluated the impact of anatomic and technical factors on LSA stent outcomes. METHODS: A single-center retrospective analysis of patients managed with single-fenestration devices (Cook Medical, Bloomington, IN, USA) for LSA preservation, between January 1, 2012 and November 30, 2023, was conducted. Anatomic (arch type, bovine arch, distance between the LSA and most proximal bone structure, left common carotid artery and aortic lesion, take-off angle, diameter, thrombus, calcification, dissection, tortuosity) and technical parameters (stent type, diameter, length, relining, post-dilation) were evaluated. Stent compression was any ≥50% stenosis (using center luminal line) of the stent compared with its initial diameter. Clinical outcomes included stroke and upper limb ischemia at 30 days and follow-up. Technical outcomes included stent compression and need for reintervention. RESULTS: Fifty-four cases were included. Only balloon-expandable covered stents were used, and relining during the index procedure was performed in 18%. No stroke or arm ischemia was recorded. One stent compression was detected at 30 days. During follow-up, no stroke or arm ischemia was diagnosed. Nine cases (18%) presented stent compression, with a mean time of stent-compression diagnosis at 18 months (interquartile range [IQR]=37, range=1-58 months) after the index procedure. Five (56%) underwent secondary relining. Follow-up after reintervention was uneventful. Lower distance to the nearest bone structure (compression group [CG]: 11.7±8.9 mm vs non-compression group [NCG]: 23.0±7.8 mm, p=0.003) and higher tortuosity index (CG: 1.3±0.4 vs NCG: 1.2±0.1, p=0.03) were associated with LSA stent compression. CONCLUSION: LSA stent compression in patients managed with f-Arch affected 1 in 5 cases, without clinical consequences. Distance to the nearest bone structure and higher tortuosity were associated with LSA stent compression. CLINICAL IMPACT: Fenestrated endovascular arch repair for the preservation of the left subclavian artery (LSA) in patients needing landing within the aortic arch has been performed with encouraging outcomes. This analysis showed that LSA stent compression is met in 18% of patients, without though any clinical consequence. Pre-operative anatomic parameters, as lower distance to the nearest bone structure and higher tortuosity index affect negatively LSA stent performance while stent parameters seem to have no impact.

Appropriateness of care in complex fenestrated-branched aortic endografting.

Fenestrated and branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms is increasingly replacing open repair as the primary modality of treatment. Mid- and long-term results are encouraging and support its use in the correct settings. Nevertheless, appropriateness of indication for treatment, patient selection, and surgeon and hospital performance has not been clearly evaluated and reviewed. The objective of this review article was to identify areas in which appropriateness of care is relevant and can be optimized when considering treatment of patients with fenestrated and branched endovascular repair for complex abdominal and thoracoabdominal aortic aneurysms.

Clinical efficacy of TEVAR utilizing fenestrated stent-grafts for zone 0 in an elderly frail patient with giant aortic arch aneurysm.

Introduction and importance: Elderly and frail patients with thoracic aortic aneurysms (TAAs) near to origins of cervical arteries present facing challenges with aortic arch replacement with cardiopulmonary bypass, and traditional tube-type stent-grafts are also inadequate for transcatheter endovascular aortic repair (TEVAR). Thus, necessitating precise treatment with fenestrated stent-grafts from zone 0. This approach is crucial for achieving favorable postoperative outcomes without compromising activities of daily living (ADL). Case presentations: An 85-year-old-man admitted to the hospital for treatment of a large TAA. While arch replacement is a definitive procedure, it is highly invasive, and the postoperative ADL are expected to be significantly lower than preoperative levels. Therefore, we performed a debranching TEVAR from Zone 0 with fenestrated stent-graft. The patient was discharged from the hospital on the 11th postoperative day. Clinical discussion: In frail and elderly patients for whom conventional surgery may not be viable, TEVAR emerges as a preferred alternative. However, TEVAR of TAA proximal to the aortic arch continues to pose challenges, necessitating meticulous attention to the cervical branches in the intervention strategy. While surgical intervention in these patients necessitates careful consideration of its suitability, including the potential for postoperative enhancement in ADL, the use of fenestrated stent-grafts from Zone 0 emerges as one of the treatment modalities. Conclusion: The authors present a very elderly case in which fenestrated stent-grafts were used to avoid aortic arch replacement for a large aortic arch aneurysm, resulting in a good postoperative course with no decline in ADL.

Tailoring fenestrated aneurysm clips intraoperatively: Instant solution for a difficult problem.

The anterior communicating artery (AcoA) aneurysms represent the most complex aneurysms of the anterior circulation. For years, surgical challenges including the intricate anatomy and narrow surgical corridor have been overcome using supplementary techniques including extended craniotomies, wide opening of the cisterns, gyrus rectus resection and special clips like fenestrated clips. However, imaginative solutions such as intraoperative clip modification may be inevitable in particular cases for safe clipping. We retrospectively analyzed clinical records of two patients who required clip modification intraoperatively. Case #1 underwent microsurgical clipping of a ruptured, 4-mm AcoA aneurysm. Unfortunately, given the short distance between the two A2s, it was not possible to clip the aneurysm without a compromise to the contralateral A2 with the available shortest 3mm-fenestrated clip. We then used the clip modification technique intraoperatively by shortening the clip tips with mesh-plaque cutter and smoothening the remaining sharp ends using cautery sanding. Eventually, the aneurysm was clipped successfully with the modified-fenestrated clip. Post-clipping imagings confirmed complete occlusion of the aneurysm and patency of parent arteries. Case 2# underwent microsurgical clipping for a ruptured, 1-mm AcoA aneurysm. Like Case 1#, the initial clipping attempt with the available shortest 4mm-fenestrated clip failed given the excessive length of the tips. The patient, thus, required clip modification as described above. The aneurysm was then clipped successfully using the modified-fenestrated clip, protecting bilateral A2s. Post-clipping imagings demonstrated patency of parent arteries with no residual aneurysm filling. Clip modification seems to be an effective option in clipping the AcoA aneurysms when available clips are too long to secure them safely.

Proximal sealing in the aortic arch for inner curve disease using the Custom Relay scalloped and fenestrated stent graft.

OBJECTIVE: This study aimed to analyze early and midterm results of custom-made proximal scallop and fenestrated stent grafts for thoracic endovascular aortic repair (TEVAR) with a proximal landing zone (PLZ) in the aortic arch. METHODS: All consecutive patients treated with the custom made proximal scalloped and fenestrated Relay stent grafts (Terumo Aortic Bolton Medical Inc.) in 10 Italian centers between January 2014 and December 2022 were included. The primary end points were technical success, incidence of intraoperative major adverse events, deployment accuracy, and rate of early neurological complications, endoleaks (ELs) and retrograde aortic dissection. RESULTS: During the study period, 49 patients received TEVAR with Relay custom-made endograft in Italy were enrolled. The median patient age was 70.1 years (interquartile range, 23-86 years) and 65.3% were male. The indication for treatment was atherosclerotic aneurysms in 59.2% of cases and penetrating aortic ulcer in 22.4%. The endograft configuration was proximal fenestration in 55.1% and scallop in 44.9%. The proximal landing zone was zone 0 in 25 cases (51%), zone 1 in 14 cases (28.6%), and zone 2 in 10 cases (20.4%). The supra-aortic debranching procedures were 38 (77.5%). Technical success was 97.9% (48/49) owing to one case (2.0%) of inaccurate deployment. Intraoperatively, one (2.0%) type Ia and one (2.0%) type III EL were detected. There were no cases of in-hospital mortality, major adverse events, or retrograde dissection. Three minor strokes (6.1%) (National Institutes of Health Stroke Scale score of ≤4) were observed. At a mean follow-up time of 36.3 ± 21.3 months the rate of types I to III ELs and reintervention was 4.1%, respectively. Four patients (8.2%) died during the follow-up period, one (2.1%) from abdominal aortic rupture and three (6.1%) from nonaortic causes. CONCLUSIONS: Our early and midterm outcomes suggest that scalloped and fenestrated TEVAR may provide an acceptable alternative treatment option for aortic arch pathologies. Large-scale studies are needed to assess the long-term durability of this technique.

Multicenter Study on Physician-Modified Endografts for Thoracoabdominal and Complex Abdominal Aortic Aneurysm Repair.

BACKGROUND: Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal aortic aneurysm, however, previous data are limited to small single center studies and robust data on safety and effectiveness of PMEGs are lacking. We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. METHODS: An international multicenter single-arm cohort study was performed analyzing the outcomes of PMEGs in the treatment of elective, symptomatic, and ruptured complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. Variables and outcomes were defined according to the Society for Vascular Surgery reporting standards. Device modification and procedure details were collected and analyzed. Efficacy outcomes included technical success and safety outcomes included major adverse events and 30-day mortality. Follow-up outcomes included reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. Multivariable analysis was performed aiming at identifying predictors of technical success, 30-day mortality, and major adverse events. RESULTS: Overall, 1274 patients were included in the study from 19 centers. Median age was 74 (IQR, 68-79), and 75.7% were men; 45.7% were complex abdominal aortic aneurysms, and 54.3% were thoracoabdominal aortic aneurysms; 65.5% patients presented electively, 24.6% were symptomatic, and 9.9% were ruptured. Most patients (83.1%) were submitted to a fenestrated repair, 3.6% to branched repair, and 13.4% to a combined fenestrated and branched repair. Most patients (85.8%) had ≥3 target vessels included. The overall technical success was 94% (94% in elective, 93.4% in symptomatic, and 95.1% in ruptured cases). Thirty-day mortality was 5.8% (4.1% in elective, 7.6% in symptomatic, and 12.7% in ruptured aneurysms). Major adverse events occurred in 25.2% of cases (23.1% in elective, 27.8% in symptomatic, and 30.3% in ruptured aneurysms). Median follow-up was 21 months (5.6-50.6). Freedom from reintervention was 73.8%, 61.8%, and 51.4% at 1, 3, and 5 years; primary target vessel patency was 96.9%, 93.6%, and 90.3%. Overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6%, and 55.0%/89.1% at 1, 3, and 5 years. CONCLUSIONS: PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data and future prospective studies are needed for more robust and detailed analysis.

Intra- and Early Post-Operative Factors Affecting Spinal Cord Ischemia in Patients Undergoing Fenestrated and Branched Endovascular Aortic Repair.

Background: Spinal cord ischemia (SCI) is a severe complication after fenestrated/branched endovascular repair (f/bEVAR). The underlying causes of SCI are still under investigation. This study aimed to evaluate intra- and early post-operative parameters that may affect SCI evolution. Methods: A single-center retrospective analysis was conducted including SCI patients with complete anesthesiologic records (1 January 2011 to 31 December 2023). Values of intra-operative glucose, hemoglobin, lactate, activated clotting time (ACT), and the need for transfusion were collected. The cohort was compared to a matched cohort of non-SCI patients. Results: Fifty-one patients with SCI and complete anesthesiologic records were included (mean age: 69.8 ± 6.2 years; 39.2% male). Intra-operative glucose value < 110 mg/dL (AUC: 0.73; sensitivity 91%, specificity of 83%) and hemoglobin value > 8.5 mg/dL (AUC: 0.61; sensitivity 83%, specificity 78%) were protective for Grade 3 SCI. Twenty-three patients with SCI were matched to 23 patients without SCI. SCI patients presented significantly higher glucose levels intra-operatively (glucose mean value: SCI 150 ± 46 mg/dL vs. non-SCI: 122 ± 30 mg/dL, p = 0.005). ACT (SCI 259 ± 31 svs. non-SCI 288 ± 28 s, p = 0.001), volume input (SCI 4030 ± 1430 mL vs. non-SCI 3020 ± 113 mL, p = 0.009), and need for transfusion (SCI: 52.5% vs. 4.3%, p < 0.001) were related to SCI. Higher glucose levels were detected among patients with SCI, at 24 (SCI: 142 ± 30 mg/dL vs. non-SCI: 118 ± 26 mg/dL, p=0.004) and 48 h (SCI: 140 ± 29 mg/dL vs. non-SCI: 112 ± 20 mg/dL, p < 0.001) post-operatively. Conclusions: SCI is a multifactorial complication after f/bEVAR. Intra-operative and early post-operative glucose levels may be related to SCI evolution. Targeted glucose < 110 mg/dL may be protective for Grade 3 SCI.

Postdissection aortic aneurysm sac enlargement after fenestrated and branched endovascular aortic aneurysm repair.

OBJECTIVES: Aneurysm sac changes after fenestrated-branched endovascular aneurysm repair (FBEVAR) for postdissection thoracoabdominal aortic aneurysms (PD-TAAs) are poorly understood. Partial thrombosis of the false lumen and endoleaks may impair sac regression. To characterize sac changes after FBEVAR for PD-TAAs, this study examined midterm results and predictors for sac enlargement. METHODS: FBEVARs performed for PD-TAAs in 10 physician-sponsored investigational device exemption studies from 2008 to 2023 were analyzed. The maximum aortic aneurysm diameter was compared between the 30-day computed tomography angiogram and follow-up imaging studies. Aneurysm sac enlargement was defined as an increase in diameter of ≥5 mm. Kaplan-Meier curves and Cox regression were used to evaluate sac enlargement and midterm FBEVAR outcomes. RESULTS: Among 3296 FBEVARs, 290 patients (72.4% male; median age, 68.4 years) were treated for PD-TAAs. Most aneurysms treated were extent II (72%) and III (12%). Mean aneurysm diameter was 66.5 ± 11.2 mm. Mortality at 30 days was 1.4%. At a mean follow-up of 2.9 ± 1.9 years, at least one follow-up imaging study revealed sac enlargement in 43 patients (15%), sac regression in 115 patients (40%), and neither enlargement nor regression in 137 (47%); 5 (2%) demonstrated both expansion and regression during follow-up. Freedom from aneurysm sac enlargement was 93%, 82%, and 80% at 1, 3, and 5 years, respectively. Overall, endoleaks were detected in 27 patients (63%) with sac enlargement and 143 patients (58%) without enlargement (P = .54). Sac enlargement was significantly more frequent among older patients (mean age at the index procedure, 70.2 ± 8.9 years vs 66.5 ± 11 years; P = .04) and those with type II endoleaks at 1 year (74% vs 52%; P = .031). Cox regression revealed age >70 years at baseline (hazard ratio [HR], 2.146; 95% confidence interval [CI], 1.167-3.944; P = .010) and presence of type II endoleak at 1 year (HR, 2.25; 95% CI, 1.07-4.79; P = .032) were independent predictors of sac enlargement. Patient survival was 92%, 81%, and 68% at 1, 3, and 5 years, respectively. Cumulative target vessel instability was 7%, and aneurysm-related mortality was 2% at 5 years. At least 42% of patients required secondary interventions. Sac enlargement did not affect patient survival. CONCLUSIONS: Aneurysm sac enlargement occurs in 15% of patients after FBEVAR for PD-TAAs. Elderly patients (>70 years at baseline) and those with type II endoleaks at 1 year may need closer monitoring and secondary interventions to prevent sac enlargement. Despite sac enlargement in some patients, aneurysm-related mortality at 5 years remains low and overall survival was not associated with sac enlargement.

Aneurysm sac shrinkage at 1 year after fenestrated-branched endovascular aortic repair of complex aortic aneurysms offers mid-term survival advantage.

OBJECTIVES: To investigate the impact of 1-year changes in aneurysm sac diameter on patient survival after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms or thoracoabdominal aortic aneurysms. METHODS: We reviewed the clinical data of patients enrolled in a prospective nonrandomized study investigating FB-EVAR (2013-2022). Patients with sequential follow up computed tomography scans at baseline and 6 to 18 months after FB-EVAR were included in the analysis. Aneurysm sac diameter change was defined as the difference in maximum aortic diameter from baseline measurements obtained in centerline of flow. Patients were classified as those with sac shrinkage (≥5 mm) or failure to regress (<5 mm or expansion) according to sac diameter change. The primary end point was all-cause mortality. Secondary end points were aortic-related mortality (ARM), aortic aneurysm rupture (AAR), and aorta-related secondary intervention. RESULTS: There were 549 patients treated by FB-EVAR. Of these, 463 patients (71% male, mean age, 74 ± 8 years) with sequential computed tomography imaging were investigated. Aneurysm extent was thoracoabdominal aortic aneurysms in 328 patients (71%) and abdominal aortic aneurysms in 135 (29%). Sac shrinkage occurred in 270 patients (58%) and failure to regress in 193 patients (42%), including 19 patients (4%) with sac expansion at 1 year. Patients from both groups had similar cardiovascular risk factors, except for younger age among patients with sac shrinkage (73 ± 8 years vs 75 ± 8 years; P < .001). The median follow-up was 38 months (interquartile range, 18-51 months). The 5-year survival estimate was 69% ± 4.1% for the sac shrinkage group and 46% ± 6.2% for the failure to regress group. Survival estimates adjusted for confounders (age, chronic pulmonary obstructive disease, chronic kidney disease, congestive heart failure, and aneurysm extent) revealed a higher hazard of late mortality in patients with failure to regress (adjusted hazard ratio, 1.72; 95% confidence interval, 1.18-2.52; P = .005). The 5-year cumulative incidences of ARM (1.1% vs 3.1%; P = .30), AAR (0.6% vs 2.6%; P = .20), and aorta-related secondary intervention (17.0% ± 2.8% vs 19.0% ± 3.8%) were both comparable between the groups. CONCLUSIONS: Aneurysm sac shrinkage at 1 year is common after FB-EVAR and is associated with improved patient survival, whereas sac enlargement affects only a minority of patients. The low incidences of ARM and AAR indicate that failure to regress may serve as a surrogate marker for nonaortic-related death.

Outcomes of advanced EVAR versus open surgery in the management of complex abdominal aortic aneurysm repair: A systematic review and meta-analysis.

BACKGROUND: Open surgery is still acknowledged as the gold standard for complex abdominal aortic aneurysm (c-AAA). Recently, advanced-endovascular aortic aneurysm repair (EVAR) for c-AAA has been developed, but its effectiveness compared to open surgery is still unclear. METHOD: A systematic search was performed on the MEDLINE through PubMed and ScienceDirect databases. The search was aimed to investigate outcomes of both fenestrated- and chimney-EVAR (consider as advanced EVAR) compared to open surgery in c-AAA. Outcomes included postoperative complications, 30-day mortality, long-term mortality, and reintervention rate. Data were collected using the Mantel-Haenszel fixed effects model with relative risk (RR) as the effect size with 95% confidence interval (CI). RESULTS: A total of 25 studies (n = 12,845 patients) were included in our study. The results demonstrated that advanced-EVAR correlated with diminished postoperative complications (RR 0.53; 95% CI 0.49-0.57; p < 0.001) compared to open surgery. Advanced-EVAR was associated with lower 30-day mortality compared to open surgery (RR 0.66; 95% CI 0.53-0.82; p < 0.001). Subgroup analysis revealed that fenestrated-EVAR resulted in superior outcomes (p < 0.001), whereas the chimney-EVAR subgroup did not show significant differences (p = 0.79), compared to open surgery in terms of 30-day mortality. Unfortunately, advanced-EVAR was associated with a higher long-term mortality rate (RR 1.46; 95% CI 1.20-1.78; p < 0.001) and a higher reintervention rate (RR 1.26; 95% CI 1.01-1.59; p = 0.04) compared to open surgery. CONCLUSION: Advanced EVAR, especially fenestrated-EVAR, presented better short-term outcomes compared to open surgery; however, it failed to demonstrate superiority over open surgery in improving long-term outcomes.

Early experience with patient-specific unibody bifurcated fenestrated-branched devices for complex endovascular aortic aneurysm repair.

OBJECTIVE: Short distances between the lowest visceral/renal artery and the aortic bifurcation are technically challenging during complex endovascular aortic aneurysm repair (EVAR), particularly after previous infrarenal repair. Traditionally, inverted limb bifurcated devices have been used in addition to fenestrated-branched (FB) endografts, but short overlap, difficult cannulation, and potential crushing of bridging stents are limitations for their use. This study reviews the early experience of patient-specific company manufactured devices (PS-CMDs) with a unibody bifurcated FB design for complex EVAR. METHODS: Consecutive complex EVAR procedures over a 34-month period with unibody bifurcated FB-devices as part of physician-sponsored investigational device exemption studies at two institutions were reviewed. Unibody bifurcated FB designs included FB bifurcated or fenestrated inverted limb devices. End points included technical success, survival, frequency of type I or III endoleaks, limb occlusion, and secondary interventions. RESULTS: Among 168 patients undergoing complex EVAR, 33 patients (19.6%; 78.7% male; mean age, 77 years) received unibody bifurcated FB PS-CMDs. FB bifurcated and fenestrated inverted limb devices were used in 31 (93.9%) and 2 (6.06%) patients, respectively. The median maximum aneurysm diameter was 61 mm (interquartile range [IQR], 55-69 mm). Prior EVAR was reported by 29 patients (87.9%), of whom 2 (6.06%) had suprarenal stents. A short distance between the lowest renal artery and aortic bifurcation was demonstrated in 30 patients (90.9%), with median distance of 47 mm (IQR, 38-54 mm). Preloaded devices were used in 23 patients (69.7%). A total of 128 fenestrations were planned; 22 (17.2%) were preloaded with guidewires and 5 (3.9%) with catheters. The median operative time was 238 minutes (226-300 minutes), with a median fluoroscopy time of 65.5 minutes (IQR, 56.0-77.7 minutes) and a median dose area product of 147 mGy∗cm2 (IQR, 105-194 mGy∗cm2). Exclusive femoral access was used in 14 procedures (42.4%). Technical success was 100%. Target vessel primary patency was 100% at a median follow-up time of 11.7 months (IQR, 3.5-18.6 months). Two patients (6.06%) required reintervention for iliac occlusion; one patient required stenting and the other a femoral-femoral bypass. No aortic-related deaths occurred after the procedure. During follow-up, 11 type II endoleaks (33.3%) and 1 type Ib endoleak (3.03%) were detected; the latter was treated with leg extension. No type Ia or III endoleaks occurred. CONCLUSIONS: Complex EVAR using unibody bifurcated FB-PS-CMDs is a simple, safe, and cost-effective alternative for the treatment of patients with short distances between the renal arteries and the aortic bifurcation. Further studies are required to assess benefits and durability of unibody bifurcated FB devices.

Fenestrated Endovascular Repair Using Short Tipped Distal Components with No Cross Concept to Prevent Crushing of Target Vessel Bridging Stents.

OBJECTIVE: To compare and evaluate early and midterm outcomes of a novel no cross approach with short tip vs. standard tip introducer systems for all distal components to prevent target vessel bridging stent kink or collapse during fenestrated endovascular aortic repair (FEVAR). METHODS: A retrospective analysis was conducted on all patients who underwent FEVAR at a tertiary referral centre between October 2016 and July 2022. The inclusion criterion was the use of renal artery fenestrations. Patients who had chronic dissections were included. Endpoints were analysed in two groups comprising the no cross group and the standard group, with all cases being consecutive in their respective groups. Cone beam computed tomography was used intra-operatively in all cases, and post-operative computed tomography angiograms and re-interventions were reviewed. Primary endpoints included technical success, intra-operative adjunctive procedures, adverse events related to the fenestration, and re-interventions, while secondary endpoints were secondary interventions and overall mortality rate. RESULTS: Seventy patients (35 in each group) were enrolled in the study, with 64 (91%) having juxtarenal aneurysms. There were no differences in demographics, cardiovascular risk factors, or aneurysm characteristics between the two groups. The no cross group demonstrated a significantly higher technical success rate (100% in all cases) compared with the standard group (29 cases, 83%; p = .010). Additionally, there were statistically significantly fewer intra-operative adjunctive procedures required in the no cross group (1.5% of fenestrations) compared with the standard group (8.2% of fenestrations) (p = .013). The overall median follow up was 32 months (interquartile range 22, 62 months). CONCLUSION: Implementation of a novel no cross concept during FEVAR, using a short dilator introducer tip on the distal bifurcated component and iliac extensions, significantly reduced intra-operative fenestration related adverse events and enhanced technical success. Further studies with larger patient populations and longer follow up are needed to confirm these findings.

Preoperative risk factors for 1-year mortality in patients undergoing fenestrated endovascular aortic aneurysm repair in the US Aortic Research Consortium.

BACKGROUND: Early survival (1-year) after elective repair of complex abdominal aortic aneurysms (AAA) or thoracoabdominal aortic aneurysms (TAAA) can be used as an indicator of successful repair and provides a reasonable countermeasure to the annual rupture risk based on diameter. We aimed to identify preoperative factors associated with 1-year mortality after fenestrated or branched endovascular aortic repair (F/BEVAR) and develop a predictive model for 1-year mortality based on patient-specific risk profiles. METHODS: The US-Aortic Research Consortium database was queried for all patients undergoing elective F/BEVAR for complex AAA (cAAA) or TAAA from 2005 to 2022. The primary outcome was 1-year survival based on preoperative risk profile. Multivariable Cox regression was used to determine preoperative variables associated with 1-year mortality overall and by extent of aortic pathology. Logistic regression was performed to build a predictive model for 1-year mortality based on number of risk factors present. RESULTS: A total of 2099 patients met the inclusion criteria for this study (cAAA: n = 709 [34.3%]; type 1-3 TAAA: n = 777 [37.6%]; type 4-5 TAAA: n = 580 [28.1%]). Multivariable Cox regression identified the following significant risk factors associated with 1-year mortality: current smoker, chronic obstructive pulmonary disease, congestive heart failure (CHF), aortic diameter >7 cm, age >75 years, extent 1-3, creatinine >1.7 mg/dL, and hematocrit <36%. When stratified by extent of aortic involvement, multivariable Cox regression revealed risk factors for 1-year mortality in cAAA (CHF maximum aortic diameter >7 cm, hematocrit <36 mg/dL, and current smoking status), type 1-3 TAAA (chronic obstructive pulmonary disease, CHF, and age >75 years), and type 4-5 TAAA (age >75 years, creatinine >1.7 mg/dL, and hematocrit <36 mg/dL). Logistic regression was then used to develop a predictive model for 1-year mortality based on patient risk profile. Appraisal of the model revealed an area under the curve of 0.64 (P < .001), and an observed to expected ratio of 0.85. CONCLUSIONS: This study describes multiple risk factors associated with an increase in 1-year mortality after F/BEVAR. Given that elective repair of cAAA or TAAA is offered to some patients in whom future rupture risk outweighs operative risk, these findings suggest that highly comorbid patients with smaller aneurysms may not benefit from repair. Descriptive and predictive models for 1-year mortality based on patient risk profiles can serve as an adjunct in clinical decision-making when considering elective F/BEVAR.

Examining the impact of median arcuate ligament-induced celiac artery compression on target vessel patency, long-term survival and device integrity in fenestrated and branched endovascular repairs.

OBJECTIVE: To evaluate the impact of celiac artery (CA) compression by median arcuate ligament (MAL) on technical metrics and long-term CA patency in patients with complex aortic aneurysms undergoing fenestrated/branched endograft repairs (F/B-EVARs). METHODS: Single-center, retrospective review of patients undergoing fenestrated/branched endovascular aortic aneurysm repairs and requiring incorporation of the CA between 2013 and 2023. Patients were divided into two groups-those with (MAL+) and without (MAL-) CA compression-based on preoperative computed tomography angiography findings. MAL was classified in three grades (A, B, and C) based on the degree and length of stenosis. Patients with MAL grade A had ≤50% CA stenosis measuring ≤3 mm in length. Those with grade B had 50% to 80% CA stenosis measuring 3 to 8 mm long, whereas those with grade C had >80% stenosis measuring >8 mm in length. End points included device integrity, CA patency and technical success-defined as successful implantation of the fenestrated/branched device with perfusion of CA and no endoleak. RESULTS: One hundred and eighty patients with complex aortic aneurysms (pararenal, 128; thoracoabdominal, 52) required incorporation of the CA during fenestrated/branched endovascular aortic aneurysm repair. Majority (73%) were male, with a median age of 76 years (interquartile range [IQR], 69-81 years) and aneurysm size of 62 mm (IQR, 57-69 mm). Seventy-eight patients (43%) had MAL+ anatomy, including 33 patients with MAL grade A, 32 with grade B, and 13 with grade C compression. The median length of CA stenosis was 7.0 mm (IQR, 5.0-10.0 mm). CA was incorporated using fenestrations in 177 (98%) patients. Increased complexity led to failure in CA bridging stent placement in four MAL+ patients, but completion angiography showed CA perfusion and no endoleak, accounting for a technical success of 100%. MAL+ patients were more likely to require bare metal stenting in addition to covered stents (P = .004). Estimated blood loss, median operating room time, contrast volume, fluoroscopy dose and time were higher (P < .001) in MAL+ group. Thirty-day mortality was 3.3%, higher (5.1%) in MAL+ patients compared with MAL- patients (2.0 %). At a median follow-up of 770 days (IQR, 198-1525 days), endograft integrity was observed in all patients and CA events-kinking (n = 7), thrombosis (n = 1) and endoleak (n = 2) -occurred in 10 patients (5.6%). However, only two patients required reinterventions. MAL+ patients had overall lower long-term survival. CONCLUSIONS: CA compression by MAL is a predictor of increased procedural complexity during fenestrated/branched device implantation. However, technical success, long-term device integrity and CA patency are similar to that of patients with MAL- anatomy.