Disease-Specific Patient-Reported Quality of Life after Fenestrated/Branched Endovascular Aortic Aneurysm Repair.

OBJECTIVES: Fenestrated-branched endovascular technology (F/B-EVAR) is increasingly used to repair complex aortic aneurysms. While reintervention, morbidity and mortality after F/B-EVAR have been well-characterized, studies on patient-reported quality of life (QOL) after F/B-EVAR have been limited in their use of non-specific instruments and measures. We report on disease-specific QOL in patients that underwent F/B-EVAR using a validated QOL survey for aortic aneurysms. METHODS: Prospectively maintained databases were used to contact living patients that underwent F/B-EVAR for pararenal or thoracoabdominal aortic aneurysms at two institutions. Eligible patients (n=286) were asked to complete a disease-specific QOL survey previously validated in patients that underwent repair of an infrarenal abdominal aortic aneurysm. An emotional impact score (EIS) from 0-100 was derived from the survey with higher scores indicating more emotional impact and worse QOL. Respondent behavior change following F/B-EVAR was evaluated in four domains (strenuous activity, travel, heavy lifting, and sexual activity) previously identified by patients to be most impacted by an aortic aneurysm. RESULTS: In total, 234 patients (82%) completed surveys. Mean post-operative interval to survey completion was 3.4±2.8 years. Mean EIS was 16 (range 0-91) for all patients surveyed, with higher mean EIS among those within the first year after F/B-EVAR (20 vs 14). Most respondents demonstrated limited adverse emotional impact after F/B-EVAR. However, the 4th quartile of EIS was broad (22-91), indicating that a subset of respondents had significantly worse QOL after repair. While most patients reported no post-procedure change in each of the activity domains, over 40% of patients did report decrease in strenuous activity and heavy lifting after F/B-EVAR. Those with decreased activity after repair had corresponding deficiencies in disease-specific knowledge for the domains of heavy lifting (p<0.001) and sexual activity (p=0.17). CONCLUSIONS: The majority of patients who underwent F/B-EVAR in this cohort had low emotional impact on their QOL after repair. One-quarter of patients did report significant post-procedure anxiety about their aneurysm, with improvement observed beyond one year after repair. Most patients reported unchanged or decreased activity levels following F/B-EVAR, and less aneurysm-specific patient knowledge was associated with decreased activity after repair. These findings are similar to those seen in prior work using this survey instrument in patients that underwent infrarenal aneurysm repair. This work confirms the feasibility of using this survey to evaluate QOL in patients with complex aortic disease. Longitudinal evaluation in these patients may identify those at high-risk for worse QOL after F/B-EVAR.

Long-term results of fenestrated and branched endovascular aneurysm repair for complex abdominal and thoracoabdominal aortic aneurysms in young and fit patients.

BACKGROUND: Endovascular repair of complex abdominal aortic aneurysms (CAAAa) and thoracoabdominal aortic aneurysms (TAAAs) with fenestrated and branched devices (F/BEVAR) represents the first-line treatment in old or unfit patients. Currently, the widespread diffusion of these techniques has led to a progressive increase of complex endovascular procedures also in younger and fitter patients, but the related results have been only minimally reported, without long-term data. We investigated the long-term results of F/BEVAR for CAAA and TAAA repair in young and fit patients. METHODS: All consecutive patients, aged ≤70 years, who underwent F/BEVAR for CAAA and TAAA over the last 13 years at two tertiary institutions were included in the study. All subjects presented a low to intermediate risk according to the Society for Vascular Surgery clinical comorbidity grading system. The primary end points were technical and clinical success and late overall and aortic-related survival. Major complications and specific target vessel-related outcomes were investigated as secondary end points. RESULTS: A total of 183 patients (155 males [84.7%]; mean age, 64.5 ± 5.7 years; range, 33-70 years) underwent F/BEVAR during the study period, for a total of 167 degenerative (91.3%) and 16 postdissection (8.7%) aneurysms, including 44 (24%) juxtarenal, 33 (18%) pararenal, and 106 (58%) TAAAs. Technical and clinical success were achieved in 176 patients (96.2%) and 171 patients (93.4%), respectively. Four patients (2.2%) died perioperatively, of which two (1.1%) operated in emergency. Postoperatively, five patients (2.7%) presented permanent grade 3 spinal cord injury and three (1.6%) renal failure needing permanent dialysis. The mean follow-up was 65.7 ± 39.6 months (range, 1-158 months). The estimated overall and aortic-related survival at 12, 60, and 120 months was 94.0%, 85.1%, 72.2%, and 97.8%, 97.8%, 96.2%, respectively, and reintervention and branch instability-free survival at the same time points were 84.4%, 71.8%, 71.8%, and 93.2%, 86.3%, 72.2%, respectively. An aneurysm growth of >5 mm was detected in six patients (3.3%), and a sac shrinkage of >5 mm was achieved in 118 cases (64.5%). The Cox regression analysis demonstrated the need for unplanned procedure as the only risk factor for overall mortality (odds ratio, 3.331; 95% confidence interval, 1.397-7.940; P < .01]. CONCLUSIONS: F/BEVAR in young and fit patients led to low perioperative mortality and major morbidity rates and a favorable overall survival rate in the long-term, making this technique particularly appealing in such a subgroup of patients. The availability of long-term data derived from the results of young patients, may additionally provide helpful information to redefine the indications for treatment and allow future targeted device and technique improvements.

Percutaneous gluteal artery access to embolize false lumen of type B aortic dissection in marfan patient.

This case study presents an innovative endovascular approach using percutaneous gluteal artery access for embolizing the false lumen of a type B aortic dissection in a patient with Marfan syndrome. Following multiple complex surgeries, the patient developed an enlarging thoraco-abdominal aneurysm, necessitating an urgent intervention branched endoprosthesis despite persisting false lumen perfusion. Doppler ultrasound-guided percutaneous gluteal access was utilized for spiral-coil embolization of the false lumen. Successful embolization and exclusion of the aneurism, confirmed by follow-up angiography and computed tomography scans, demonstrated the technique's efficacy and safety. This approach underscores the need for innovative solutions addressing complex vascular pathologies in patients with Marfan.

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.

Effect of Family History of Aortic Disease on Outcomes of Fenestrated and Branched Endovascular Aneurysm Repair of Complex Aortic Aneurysms.

OBJECTIVE: The clinical significance of family history (FH) of aortic disease on the outcomes of fenestrated and branched endovascular aneurysm repair (FB-EVAR) has not been well described. This study aimed to assess how FH of aortic disease affects outcomes following FB-EVAR for complex aortic aneurysms (CAAs). METHODS: This study retrospectively reviewed the clinical data of consecutive patients enrolled in 10 ongoing, prospective, non-randomised, physician sponsored, investigational device exemption studies to evaluate FB-EVAR (2005 - 2022) in the United States Aortic Research Consortium database. Patients were stratified by presence or absence of FH of any aortic disease in any relative. Patients with confirmed genetically triggered aortic diseases were excluded. Primary outcomes were 30 day major adverse events (MAEs) and late survival. Secondary outcomes included late secondary interventions and aneurysm sac enlargement. RESULTS: During the study period, 2 901 patients underwent FB-EVAR. A total of 2 355 patients (81.2%) were included in the final analysis: 427 (18.1%) with and 1 928 (81.9%) without a FH of aortic disease. Patient demographics, clinical characteristics, and aneurysm extent were similar between the groups. Patients with a FH of aortic disease more frequently had prior open abdominal aortic repair, but less frequently had prior endovascular aneurysm repair (p < .050). There were no statistically significant differences in 30 day mortality (4% vs. 2%; p = .12) and MAEs (12% vs. 12%; p = .89) for patients with or without a FH of aortic disease. Three year survival estimates were 71% (95% confidence interval [CI] 67 - 78%) and 71% (95% CI 68 - 74%), respectively (p = .74). Freedom from secondary intervention and aneurysm sac enlargement were also not statistically significantly different between groups. CONCLUSION: A FH of aortic disease had no impact on 30 day or midterm outcomes of FB-EVAR of CAAs. In the absence of an identified genetically triggered aortic disease, treatment selection for CAAs should be based on clinical risk and patient anatomy rather than FH of aortic disease.

Five-year outcomes of fenestrated and branched endovascular repair of complex aortic aneurysms based on aneurysm extent.

OBJECTIVE: The aim of this study was to evaluate the 5-year outcomes of fenestrated/branched endovascular aortic repair (F/BEVAR) for the treatment of complex aortic aneurysms stratified by the aneurysm extent. METHODS: Patients with the diagnosis of complex aortic aneurysm, who underwent F/BEVAR at a single center were included in this study and retrospectively analyzed. The cohort was divided according to the aneurysm extent, comparing group 1 (types I-III thoracoabdominal aneurysms [TAAAs]), group 2 (type IV TAAAs), and group 3 (juxtarenal [JRAAs], pararenal [PRAAs], or paravisceral [PVAAs] aortic aneurysms). The primary endpoints were 30-day and 5-year survival. The secondary endpoints were technical success, occurrence of spinal cord ischemia, primary patency of the visceral arteries, freedom from target vessel instability, and secondary interventions. RESULTS: Of 436 patients who underwent F/BEVAR between July 2012 and May 2023, 131 presented with types I to III TAAAs, 69 with type IV TAAAs, and 236 with JRAAs, PRAAs, or PVAAs. All cases were treated under a physician-sponsored investigational device exemption protocol with a patient-specific company-manufactured or off-the-shelf device. Group 1 had significantly younger patients than group 2 or 3 respectively (69.6 ± 8.7 vs 72.4 ± 7.1 vs 73.2 ± 7.3 years; P < .001) and had a higher percentage of females (50.4% vs 21.7% vs 17.8%; P < .001). Prior history of aortic dissection was significantly more common among patients in group 1 (26% vs 1.4% vs 0.9%; P < .001), and mean aneurysm diameter was larger in group 1 (64.5 vs 60.7 vs 63.2 mm; P = .033). Comorbidities were similar between groups, except for coronary artery disease (P < .001) and tobacco use (P = .003), which were less prevalent in group 1. Technical success was similar in the three groups (98.5% vs 98.6% vs 98.7%; P > .99). The 30-day mortality was 4.5%, 1.4%, and 0.4%, in groups 1, 2, and 3, respectively, and was significantly higher in group 1 when compared with group 3 (P = .01). The incidence of spinal cord ischemia was significantly higher in group 1 compared with group 3 (5.3% vs 4.3% vs 0.4%; P = .004). The 5-year survival was significantly higher in group 3 when compared with group 1 (P = .01). Freedom from secondary intervention was significantly higher in group 3 when compared with group 1 (P = .003). At 5 years, there was no significant difference in freedom from target vessel instability between groups or primary patency in the 1652 target vessels examined. CONCLUSIONS: Larger aneurysm extent was associated with lower 5-year survival, higher 30-day mortality, incidence of secondary interventions, and spinal cord ischemia. The prevalence of secondary interventions in all groups makes meticulous follow-up paramount in patients with complex aortic aneurysm treated with F/BEVAR.

Post-Implantation Syndrome Incidence is Higher After Complex Endovascular Aortic Procedures Than After Standard Infrarenal Repair.

OBJECTIVE: Post-implantation syndrome (PIS), characterised by malaise, fever, and increased inflammatory markers, is a common occurrence after endovascular aneurysm repair (EVAR), causing prolonged hospitalisation and increased cost. This study aimed to determine the incidence and short-term outcomes of PIS after fenestrated or branched procedures in aorto-iliac aneurysms compared with standard EVAR. METHODS: A retrospective, comparative study from a tertiary academic institution was undertaken. All patients who underwent elective EVAR with polyester stent grafts from January 2015 to June 2021 were considered. Two groups were defined: standard EVAR (sEVAR) and complex EVAR (cEVAR). The latter included visceral fenestrated and branched or iliac branch and chimney stent grafts. The primary outcome was the incidence of PIS within three days of the index procedure. Secondary outcomes were short-term complications and risk factors for PIS. A multivariable model was constructed to correct for confounders. RESULTS: Overall, 253 patients were included: 165 (65.2%) sEVAR and 88 (34.8%) cEVAR. Complex EVAR patients were younger, with larger aneurysms, had longer procedures, and were more likely to have intra-operative complications. The PIS incidence was 23.7% (n = 60), significantly higher in cEVAR (34.1% vs. 18.2%; p = .005) and increased with the complexity of the procedure (EVAR: 18.2% vs. EVAR + iliac branch device: 25.0% vs. fenestrated and branched EVAR: 36.2%; p = .030). On multivariable analysis, cEVAR (OR 2.833, 95% CI 1.295 - 6.198; p = .009) was associated with a significantly increased risk of PIS. No differences in short term outcomes according to PIS status were noted. Group sub-analysis for cEVAR patients did not reveal any statistically significantly different outcomes according to PIS occurrence. CONCLUSION: In this cohort, cEVAR procedures were associated with a significantly increased risk of developing PIS compared with standard infrarenal repair. Post-implantation syndrome also appears to have a benign course with no major impact on peri-operative outcomes after cEVAR. Further research to confirm these findings is required.

Does surgical companionship modify the learning curve for fenestrated and branched endovascular aortic repair?

OBJECTIVES: The goal of this study was to describe the learning curve of an operator trained in an aortic centre during the first years of performing fenestrated/branched endovascular aortic repairs independently. METHODS: Patients electively treated with fenestrated/branched stent grafts from January 2013 to March 2020 were included retrospectively. Groups were defined according to the treating operator: experienced operator (group 1), early-career operator (group 2) or both during a 14-month surgical companionship period (group 3). The early-career operator's learning curve was assessed using a cumulative sum analysis. A composite criterion including technical failure, death and/or any major adverse event was evaluated in a logistic regression model. RESULTS: Overall, 437 patients (93% male; median 69 (63, 77) years old) were included (group 1: n = 240; group 2: n = 173; group 3: n = 24). There were significantly more extended thoraco-abdominal aneurysms (extent I, II, III and V) in group 1 compared to group 2 [n = 68 (28%) vs 19 (11%), P<0.001]. The technical success rate was 94% (P=0.874). The 30-day mortality and/or major adverse event rates in juxta-/pararenal aneurysms or extent IV thoraco-abdominal aneurysms were 8.1% in group 1 and 9.7% in group 2 (P = 0.612), whereas they were 10% (group 1) and 0 (group 2) for extended thoraco-abdominal aneurysms (P=0.339). The adjusted cumulative sum analysis highlighted satisfactory results from the beginning of the experience. The operator's experience was not predictive of the composite criterion [adjusted OR 0.77; 95% (0.42, 1.40); P=0.40]. CONCLUSIONS: This study demonstrated favourable outcomes in patients treated with a fenestrated/branched aortic stent graft performed by an early-career operator trained in a high-volume centre from the beginning of independent practice.

Feasibility and outcome of partial open surgical fenestrated stent graft explantation, radical debridement, and in situ reconstruction for late graft infection.

Aortic stent graft infection is a rare, but potentially lethal, complication of endovascular aortic aneurysm repair. Definitive treatment is complete stent graft explanation with in-line or extra-anatomical reconstruction. However, several factors can render such an operation unsafe, including the patient's overall fitness for surgery and partial incorporation of graft with a resulting robust inflammatory process, especially around the visceral vessels. We present the case of a 74-year-old man with a history of an infected fenestrated stent graft that was managed with partial explantation, wide debridement, and in situ reconstruction using a rifampin-soaked graft and a 360° omental wrap with good results.

Effects of Iliac Tortuosity Index on Fenestrated Endovascular Aortic Aneurysm Repair for Pararenal and Thoracoabdominal Aortic Aneurysms.

PURPOSE: To evaluate the effect of iliac tortuosity on procedural metrics and outcomes of patients with complex aortic aneurysms (cAAs) undergoing repair with fenestrated/branched endografts (f/b-EVAR [endovascular aortic aneurysm repair]). MATERIAL AND METHODS: The study is a single-center, retrospective review of a prospectively maintained database of patients undergoing aneurysm repair using f/b-EVAR between the years 2013 and 2020 at our institution. Included patients had at least 1 preoperative computed tomography angiography (CTA) available for analysis. Iliac artery tortuosity index (TI) was calculated using centerline of flow imaging from a 3-dimensional work station based on the formula: (centerline iliac artery length / straight-line iliac artery length). The associations between iliac artery tortuosity and procedural metrics, including total operative time, fluoroscopy time, radiation dose, contrast volume, and estimated blood loss (EBL), were evaluated. RESULTS: During this period, 219 patients with cAAs underwent f/b-EVAR at our institution. Ninety-one patients (74% men; mean age = 75.2±7.7 years) met criteria for inclusion into the study. In this group, there were 72 (79%) juxtarenal or paravisceral aneurysms and 18 (20%) thoracoabdominal aortic aneurysms and 5 patients (5.4%) with failed previous EVAR. The average aneurysm diameter was 60.1±0.74 mm. Overall, 270 vessels were targeted, and 267 (99%) were successfully incorporated, including 25 celiac arteries, 67 superior mesenteric arteries, and 175 renal arteries. The mean total operative time was 236±83 minutes, fluoroscopy time was 87±39 minutes, contrast volume was 81±47 mL, radiation dose 3246±2207 mGy, and EBL was 290±409 mL. The average left and right TIs for all patients were 1.5±0.3 and 1.4±0.3, respectively. On multivariable analysis, the interval estimates suggest positive association between TI and procedural metrics to a certain degree. CONCLUSIONS: In the current series, we found no definitive association between iliac artery TI and procedural metrics, including operative time, contrast used, EBL, fluoroscopy time, and dose in patients undergoing cAA repair using f/b-EVAR. However, there was a trend toward association between TI and all these metrics on multivariable analysis. This potential association needs to be evaluated in a larger series. CLINICAL IMPACT: Iliac artery tortuosity should not exclude patients with complex aortic aneurysms from being offered fenestrated or branched stent graft repair. However, special considerations should be taken to mitigate the impact of access tortuosity on alignment of fenestrations with target vessels, including use of extra stiff wires, through and through access and delivering the fenestrated/branched device into another (larger) sheath such as a Gore DrySeal in patients with arteries large enough to accommodate such sheaths.

Mortality and Major Adverse Events Improve With Increased Institutional Experience for Fenestrated and Branched Endovascular Aortic Repair.

OBJECTIVE: Our objective was to evaluate temporal trends in outcomes at our institution in the context a more heterogenous application of fenestrated/branched endovascular aneurysm repair (F/BEVAR). METHODS: Patient and aneurysm characteristics, procedure details, and postoperative outcomes were collected for consecutive patients undergoing F/BEVAR between 2002 and February 2019 at our institution. Outcomes were compared between tertile 1 (T1, 2002-2010, n=47), T2 (2011-2014, n=47), and T3 (2015-February 2019, n=47). RESULTS: We included 141 patients (74.8 ± 8.1 years, 83% male) with a mean follow-up of 28.0 ± 31.6 months. Proportion of patients with hypertension (63.8% T1, 85.1% T3, p=0.009), diabetes (6.4% T1, 29.7% T3, p=0.005), chronic obstructive pulmonary disease (COPD; 27.6% T1, 42.5% T3, p=0.07), and history of stroke (4.2% T1, 17% T3, p=0.07) increased over time. Aneurysm diameter (65.3±11.4mm) and extent (56.0% juxtarenal/pararenal, 22.0% type IV, 22.0% type I-III) did not differ between groups. Custom made devices were implanted in 96.5% of cases with 3.4 ± 0.7 vessels reimplanted/case. There was a trend toward increased history of aortic surgery (p=0.008) and less custom made devices (p=0.007) in T3.Total procedure time (383.5±119.2 minutes T1, 316.2±88.4 T3, p=0.02), contrast volume (222.8±109.1 mL T1, 139.2±62.7ml T3, p<0.0001), and estimated blood loss (601.3±458.1 mL T1, 413.3±317.7 mL T3, p=0.02) decreased over time. Overall 30-day mortality was 6.3%, 10.6%-T1, 6.3%-T2, and 2.1%-T3 (p=0.09). We noted significant improvement in survival over time; 1- and 3-year survival was 79% and 56%, 89% and 83%, and 90% and 90%, for T1, T2, and T3, respectively (p=0.007). In all, 467 of 480 target vessels were revascularized (97.3% success). Reintervention rate (30-day: 13.5%, follow-up: 34.7%) and reintervention free survival was not significantly different between groups. Any major adverse event (MAE) occurred in 36.9% of patients overall with a significant decrease from early (51.1%), mid (34.9%), to late in our experience (25.5%, p=0.03). In multivariate analyses, increasing institutional experience (T3), procedure time, age, and sex were independent predictors of major adverse events. CONCLUSION: We have shown improvement in F/BEVAR outcomes including mortality, MAEs, and procedural metrics with increasing institutional experience. We postulate that a combination of advancements in technique, surgical team and postoperative care experience, graft design and stent technologies, and patient selection contributed to improvement in outcomes.

Frequency and type of interval adverse events during the waiting period to complex aortic endovascular repair.

OBJECTIVE: The aim of the present study was to evaluate the frequency and type of adverse events that can occur during the waiting period to complex aortic endovascular repair. METHODS: We performed a retrospective study of all elective patients with complex aortic aneurysms (including pararenal, suprarenal, thoracoabdominal, and aortic arch aneurysms) that had required a custom-made device (CMD) from Cook Medical (Bloomington, Ind) at a tertiary referral vascular center (November 2010 to May 2020). The waiting period was defined as the interval between the date of the stent graft order and the date of the procedure or cancellation. Interval adverse events were defined as any event that had occurred during the waiting period and led to either mortality, aneurysm rupture, or cancellation of the planned procedure. RESULTS: A total of 235 patients (mean age, 72 years; 25% female) had had a CMD graft ordered (201 planned as a single-stage procedure). The median waiting time until surgery was 106 days (interquartile range [IQR], 77-146 days) in the whole cohort and 101 days (IQR, 77-140 days) for the single-stage cohort. The planned procedure was performed electively in 219 patients (93%), with an overall 30-day elective mortality of 2% (n = 5). A total of 16 interval adverse events occurred during the waiting period. Of these 16 events, 10 were aneurysm ruptures and 6 were cancellations of the procedure owing to non-aneurysm-related deaths (3% of the entire cohort). A total of 10 interval deaths were registered (4.2%), 4 of which were aneurysm related. The risk of rupture during the waiting period (Kaplan-Meier) was 6.1% ± 2.3% at 180 days. The median interval from the stent graft order to aneurysm rupture was 101 days (IQR, 54-200 days). Of the 10 aneurysm ruptures that had occurred, 6 had undergone emergent repair, with 0% mortality at 30 days (one open repair, one t-Branch, one physician-modified endograft, two cases for which the CMD was already available, one case for which a different CMD was available). CONCLUSIONS: The median waiting time from the stent graft order to implantation was ∼15 weeks. During this waiting period, a substantial proportion of patients could experience adverse events, either related to aneurysm rupture or underlying comorbidities. The risk of rupture during the waiting period exceeded the risk of perioperative mortality. Thus, efforts to decrease this risk could significantly improve the outcomes. A combination of different techniques might play a vital role in reducing the mortality after cases of interval rupture.

Use of the Off-The-Shelf Pre-Cannulated E-Nside Endograft to Overcome Anatomical Challenges in Urgent Complex Endovascular Aortic Repair.

Treatment options for large or symptomatic complex aortic aneurysms that require urgent intervention remain limited. Patient factors and comorbidities often make open surgery unappealing, leading to increasing interest in endovascular solutions that can be employed in the urgent setting, such as off-the-shelf endografts. The E-nsideTM (Jotec GmbH, Hechingen, Germany) is a new off-the-shelf endograft with 4 pre-cannulated inner branches that has recently become available in Europe. We report the urgent treatment of 2 large complex aortic aneurysms using this device and discuss the benefits of this new technology. The E-nside off-the-shelf endograft with inner branches is a useful addition to our treatment options for complex aortic aneurysms, particularly those with a narrow aortic lumen. Pre-cannulation of branches provides consistent access to the branches and a readily available option for establishment of a through and through wire for added stability during cannulation and bridging stent-grafts placement. The design of inner branches provides flexibility during deployment of the endograft and cannulation of the target vessels in varied, challenging anatomies.

Reinterventions after fenestrated and branched endografting for degenerative aortic aneurysms.

OBJECTIVE: Fenestrated/branched endovascular abdominal aortic aneurysm repair (F/B-EVAR) is widely accepted technique to treat juxta/pararenal abdominal aortic aneurysms (J/P-AAAs) and thoracoabdominal aortic aneurysms (TAAAs) for patients at high-surgical risk. However, the follow-up results should be carefully evaluated, especially in terms of the reintervention rate. The aim of the present study was, therefore, to evaluate the early and mid-term reinterventions after FB-EVAR for J/P-AAAs and TAAAs and their effects on follow-up survival. METHODS: From 2006 to 2019, all consecutive patients who had undergone F/B-EVAR for J/P-AAAs or TAAAs were prospectively enrolled. Cases requiring reinterventions were retrospectively analyzed. Patients with aortic dissection were excluded from the present analysis. Reinterventions were classified as follows: access related, aortoiliac related, or target visceral vessel (TVV) related. Freedom from reintervention and survival were assessed using the Kaplan-Meier method, and univariate and multivariate analyses were used to determine the risk factors. RESULTS: Overall, 221 F/B-EVAR procedures were performed for 111 J/P-AAAs (50.3%) and 110 TAAAs (49.7%) in an elective (182; 82%) or urgent (39; 18%) setting. The median follow-up was 27 months (interquartile range, 13 months). Overall, 41 patients had undergone 52 reinterventions (single, 30 [14%]; multiple, 11 [5%]; access related, 17 [33%]; aortoiliac related, 6 [12%]; TVV related, 29 [55%]). Of the 52 reinterventions, 32 (62%) and 20 (38%) had occurred within and after 30 days, respectively. Eight reinterventions (15%) had been were performed in an urgent setting. Endovascular and open reinterventions were performed in 32 (62%) and 20 (38%) cases, respectively. Open reinterventions were frequently access related (access, 16; no access, 4; P ≤ .001). Technical success was 95% (39 patients); failures consisted of one splenic artery rupture and one renal artery loss. Patients undergoing reintervention had more frequently undergone a primary urgent F/B-EVAR (urgent, 12 of 39 [31%]; elective, 29 of 182 [16%]; P < .001) and had had TAAAs (TAAAs, 34 of 41 [83%]; J/P-AAAs, 7 of 41 [17%]; P < .001). The patients with TAAAs had had a greater incidence of TVV-related reintervention (TAAAs, 26 of 28 [93%]; J/P-AAAs, 2 of 28 [7%]; P < .001) and multiple reinterventions (TAAAs, 9 of 11 [82%]; J/P-AAAs, 2 of 11 [18%]; P = .03) compared with those with J/P-AAAs. Survival at 3 years was 75%. Freedom from reintervention was 81% at 3 years. Patients who had undergone reinterventions had lower 3-year survival (reintervention, 61%; no reintervention, 77%; P = .02). Preoperative chronic renal failure (hazard ratio [HR], 2.0; 95% confidence interval [CI], 1.1-3.6; P = .02), TAAAs (HR, 2.3; 95% CI, 1.1-4.8; P = .03), and urgent primary F/B-EVAR procedures (HR, 2.5; 95% CI, 1.2-4.9; P = .01) were independent predictors of late mortality. CONCLUSIONS: Reinterventions after F/B-EVAR are not uncommon and were related to TVVs in only one half of cases. Most of them can be performed in an elective setting using endovascular techniques. The technical success rate was excellent. Reinterventions were more frequent after TAAAs and urgent F/B-EVAR procedures and had a significant effect on overall survival in these situations.

Functional Performance After Complex Endovascular Aortic Repair: A Single-Center Retrospective Cohort Study.

PURPOSE: Complex endovascular aortic repair (EVAR) procedures provide a treatment option for patients with aortic aneurysms involving visceral branches. Good technical results and short-term outcomes have been reported. Whether complex EVAR provides acceptable functional outcomes is not clear. The current study aims to describe postoperative functional outcomes in complex EVAR patients-an older and relatively frail patient group. MATERIALS AND METHODS: A single-center retrospective cohort study was performed, using data from a computerized database of consecutive patients who underwent complex EVAR in the Leiden University Medical Center (LUMC, The Netherlands) between July 2013 and September 2020. As of May 2017, patients scheduled for complex EVAR were referred to a geriatric care pathway to determine (Instrumental) Activities of Daily Living ((I)ADL) scores at baseline and, if informed consent was given, after 12 months. For the total patient group, adverse functional performance outcomes were: discharge to a nursing home and 12-month mortality. For the patients included in geriatric follow-up, the additional outcome was the incidence of functional decline (defined by a ≥2 point increase in (I)ADL-score) at 12-month follow-up. RESULTS: Eighty-two patients underwent complex EVAR, of which 68 (82.9%) were male. Mean age was 73.3 years (SD=6.3). Within 30 days postsurgery, 6 patients (7.3%) died. Mortality within 12 months for the total patient group was 14.6% (n=12). After surgery, no patients had to be discharged to a nursing home. Fifteen patients (18.3%) were discharged to a rehabilitation center. Twenty-three patients gave informed consent and were included in geriatric follow-up. Five patients (21.7%) presented functional decline 12 months postsurgery and 4 patients had died (17.4%) by that time. This means that 39.1% of the patients in the care pathway suffered an adverse outcome. CONCLUSION: To our knowledge, this is the only study that examined functional performance after complex EVAR, using a prospectively maintained database. No patients were newly discharged to a nursing home and functional performance results at 12 months are promising. Future multidisciplinary research should focus on determining which patients are most prone to deterioration of function, so that efforts can be directed toward preventing postoperative functional decline.

Evolution of fenestrated/branched endovascular aortic aneurysm repair complexity and outcomes at an organized center for the treatment of complex aortic disease.

BACKGROUND: Fenestrated/branched endovascular aneurysm repair (F/BEVAR) volume has increased rapidly, with favorable outcomes at centers of excellence. We evaluated changes over time in F/BEVAR complexity and associated outcomes at a single-center complex aortic disease program. METHODS: Prospectively collected data of all F/BEVAR (definition: requiring ≥1 fenestration/branch), procedures performed in an institutional review board-approved registry and/or physician-sponsored investigational device exemption trial (IDE# G130210), were reviewed (11/2010-2/2019). Patients were stratified by surgery date into thirds: early experience, mid experience, and recent experience. Patient and operative characteristics, aneurysm morphology, device types, perioperative and midterm outcomes (survival, freedom from type I or III endoleak, target artery patency, freedom from reintervention), were compared across groups. RESULTS: For 252 consecutive F/BEVARs (early experience, n = 84, mid experience, n = 84, recent experience, n = 84), 194 (77%) company-manufactured custom-made devices, 11 (4.4%) company-manufactured off-the-shelf devices, and 47 (19%) physician-modified devices, were used to treat 5 (2.0%) common iliac, 97 (39%) juxtarenal, 31 (12%) pararenal, 116 (46%) thoracoabdominal, and 2 (0.8%) arch aneurysms. All patients had follow-up for 30-day events. The mean follow-up time for the entire cohort was 589 days (interquartile range, 149-813 days). On 1-year Kaplan-Meier analysis, survival was 88%, freedom from type I or III endoleak was 91%, and target vessel patency was 92%. When stratified by time period, significant differences included aneurysm extent (thoracoabdominal, 33% early experience, 40% mid experience, and 64% recent experience; P < .001) and target vessels per case (four-vessel case, 31% early experience, 39% mid experience, and 67% recent experience; P < .0001). There was no difference, but a trend toward improvement, in composite 30-day events (early experience, 39%; mid experience, 23%; recent experience, 27%; P = .05). On Kaplan-Meier analysis, there was no difference in survival (P = .19) or target artery patency (P = .6). There were differences in freedom from reintervention (P < .01) and from type I or III endoleak (P = .02), with more reinterventions in the early experience, and more endoleaks in the recent period. CONCLUSIONS: Despite increasing repair complexity, there has been no significant change in perioperative complications, overall survival, or target artery patency, with favorable outcomes overall. Type I or III endoleaks remain a significant limitation, with increased incidence as the number of branch arteries incorporated into the repairs has increased.

Exclusion of complex aortic aneurysm with chimney endovascular aortic repair is applicable in a minority of patients treated with fenestrated endografts.

OBJECTIVES: The Medtronic Endurant II stent graft has recently received Conformité Européenne (CE) approval for the use in chimney endovascular aortic repair (ChEVAR) for the treatment for juxtarenal aortic aneurysms. The aim of this study was to assess the percentage of patients treated by fenestrated endovascular repair who would have been alternatively suitable for the treatment by the CE approved Medtronic ChEVAR. METHODS: Preoperative computed tomography scans of 100 patients who underwent fenestrated endovascular aortic repair (FEVAR) between April 2013 and February 2017 were retrospectively assessed for the applicability of the ChEVAR technique according to the Medtronic instructions for use. Eligibility criteria included an aortic neck diameter of 19-30 mm, a minimum infrarenal neck length of 2 mm, a total proximal sealing zone of at least 15 mm, thrombus in the aortic neck in ˂25% of the circumference, and maximum aortic angulations of 60° in the infrarenal, 45° in the suprarenal segment and ˂45° above the superior mesenteric artery. RESULTS: According to CE-approved inclusion criteria, 19 individuals (19%) would have been eligible for ChEVAR. In 81 patients, at least 1 measure was found outside instructions for use: (i) excluding factor was detected in 26 patients, (ii) incongruous measures in 28 patients and in 27 patients, 3-5 measures were outside the instructions for use. The most frequently identified excluding factor was an insufficient infrarenal neck at ˂2 mm length (n = 63; 63%). CONCLUSIONS: Patients with juxta- or pararenal aneurysm treated by FEVAR are in 19% of the cases alternatively suitable for the treatment by ChEVAR within CE-approved instructions for use. While ChEVAR is suitable in many emergency cases, FEVAR offers a broader applicability in an elective setting.

Editor's Choice - Fenestrated or Branched Endovascular versus Open Repair for Complex Aortic Aneurysms: Meta-Analysis of Time to Event Propensity Score Matched Data.

OBJECTIVE: The aim of this review was to investigate comparative outcomes of fenestrated or branched endovascular aneurysm repair (F/BEVAR) with open repair for juxta/para/suprarenal or thoraco-abdominal aortic aneurysms. METHODS: Electronic bibliographic sources (MEDLINE and Embase) were interrogated using the Healthcare Databases Advanced Search interface. Eligible studies compared F/BEVAR with open repair for complex aortic aneurysms using propensity score or Cox regression modelling/multivariable logistic regression analysis. Pooled estimates of peri-operative outcomes were calculated using the odds ratio (OR) and 95% confidence interval (CI). The result of time to event analysis was reported as summary hazard ratio (HR) and 95% CI. Random effects models and the inverse variance method were applied. The quality of evidence was graded using the system developed by the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) working group. RESULTS: Eleven studies published between 2014 and 2019 were selected for inclusion in qualitative and quantitative synthesis reporting a total of at least 7 061 patients. The odds of peri-operative mortality after F/BEVAR were lower, although not significantly, than after open repair (OR 0.56, 95% CI 0.28-1.12), whereas the hazard of overall mortality during follow up was higher following F/BEVAR, but, again, without reaching statistical significance (HR 1.25, 95% CI 0.93-1.67). The hazard of re-intervention was significantly higher after endovascular therapy (HR 2.11, 95% CI 1.39-3.18). The certainty for the body of evidence for peri-operative and overall mortality during follow up was judged to be very low and moderate, respectively, and for re-intervention it was judged to be high. CONCLUSION: The evidence is uncertain about the effect of F/BEVAR on peri-operative mortality when compared with open repair. There is probably no difference in overall survival, but F/BEVAR results in an increased re-intervention hazard. There is a need for high level evidence to inform decision making and vascular/aortic service provision.

Lumbar drain complications in patients undergoing fenestrated or branched endovascular aortic aneurysm repair: Development of an institutional protocol for lumbar drain management.

OBJECTIVE: Lumbar drain placement with cerebrospinal fluid (CSF) drainage is an effective adjunct for reducing the risk of spinal cord ischemia in patients undergoing complex aortic aneurysm repair. However, lumbar drain placement is a challenging procedure with potential for significant complications. We sought to characterize complications of lumbar drain placement in a large, single-center experience of patients who underwent fenestrated or branched endovascular aneurysm repair (F/BEVAR). METHODS: All patients who underwent F/BEVAR and attempted lumbar drain placement from 2010 to 2019 were retrospectively reviewed. All lumbar drains were placed by four cardiovascular anesthesiologists who compose the complex aortic anesthesia team. Lumbar drain placement was guided by a set protocol and used whenever the aortic stent graft coverage was planned to extend more proximal than 40 mm above the celiac artery. Details relating to lumbar drain placement, management, and frequency and type of associated complications were characterized. RESULTS: During the study period, 256 patients underwent F/BEVAR, of whom 100 (39%) were planned for lumbar drain placement. Successful placement occurred in 98 (98%) of the cases. All lumbar drains were placed before induction of general anesthesia, using fluoroscopy guidance in 28 cases (28%). The most common level of placement was L4-5 (n = 42 [42%]). The majority (n = 82 [82%]) were left in place ≤48 hours; 21% were removed during the first 24 hours, and 61% were removed between 24 and 48 hours. Nonfunctionality was the most common complication, occurring in 16 (16%) patients. Catheter dislodgment or fracture, CSF leak, and postdural puncture headache were observed in 4 (4%), 7 (7%), and 4 (4%) patients, respectively. The most common bleeding complication was the presence of asymptomatic blood in the CSF (n = 11 [11%]), whereas subarachnoid hemorrhage combined with intraventricular hemorrhage occurred in three patients (3%); none of these patients required surgical drainage or intervention. No infectious complications were observed. CONCLUSIONS: Lumbar drain placement for CSF drainage is a commonly employed adjunct to prevent spinal cord ischemia in F/BEVAR. Our experience demonstrates that lumbar drain placement can be performed successfully but is associated with a significant rate of nonfunctionality and a diverse range of complications that, fortunately, do not commonly have significant long-term sequelae.

Secondary interventions after fenestrated and branched endovascular repair of complex aortic aneurysms.

OBJECTIVE: The use of fenestrated and branched endografts for the treatment of complex aortic aneurysms is increasing. Despite the low morbidity and mortality associated with these repairs, reintervention rates in the midterm and long term remain a concern. The purpose of this study was to investigate our experience with reinterventions after fenestrated and branched endovascular aneurysm repair (F/BEVAR). METHODS: We performed a retrospective analysis of all patients treated with F/BEVAR at our institution during the years 2009 to 2019. Among them, we identified those who required reinterventions during the period of follow-up. Data collected included patients' demographics, type of treated aneurysm, indications for reintervention, and methods of repair. RESULTS: During the study period, 47 patients underwent F/BEVAR. A total of 160 branches were placed. Of those, 12 patients (25%) underwent 15 secondary interventions for late-occurring complications. Among those requiring reinterventions, mean age was 70 years (range, 59-80 years), and 10 (83%) were male. The majority of those requiring reinterventions were treated for thoracoabdominal aortic aneurysms. Mean time to reintervention was 14 months (range, 2-32 months). Indications for reinterventions included separation of side branches from fenestrations (nine), separation of side branches (three), type IA endoleak (one), type II endoleak (one), and limb occlusion (one). All endoleaks were detected on routine follow-up imaging. All reinterventions were performed using endovascular techniques. Mean follow-up after reinvention was 22 months (range, 1-53 months). During this period, no patient required open conversion. Follow-up imaging revealed successful obliteration of the endoleak, and none experienced continued growth of the sac. CONCLUSIONS: Reinterventions after F/BEVAR are not uncommon. The majority of reinterventions are performed for endoleaks that are due to failure at the level of the fenestrations or component separation. These endoleaks can be treated successfully with endovascular methods and do not require open conversion. Because of the possibility of development of late endoleaks, continual monitoring of these patients is required after the primary procedure.