Age is not a sole predictor of outcomes in octogenarians undergoing complex endovascular aortic repair.

OBJECTIVE: To examine the perioperative, postoperative, and long-term outcomes of fenestrated/branched endovascular aneurysm repair (F/BEVAR) in octogenarians compared with nonoctogenarians. METHODS: A multicenter, retrospective cohort study was conducted using the Vascular Quality Improvement database, which prospectively captures information on patients who undergo vascular surgery across 1021 academic and community hospitals in North America. All patients who underwent F/BEVAR endovascular aortic repair from 2012 to 2022 were included. Patients were stratified into two groups: those aged <80 years and those aged ≥80 years at the time of the procedure. The preoperative, intraoperative, and postoperative factors were compared between the two groups. The primary outcome was long-term all-cause mortality; secondary outcomes included aortic-specific mortality and aortic-specific reintervention. RESULTS: A total of 6007 patients (aged <80 years, n = 4860; aged ≥80 years, n = 1147) who had undergone F/BEVAR procedures were included. No significant difference was found in technical success, postoperative length of stay, length of intensive care unit stay, postoperative bowel ischemia, and spinal cord ischemia. After adjustment for baseline covariates, octogenarians were more likely to suffer from a postoperative complication (odds ratio [OR]: 1.16; [95% confidence interval (CI): 0.98-1.37], P < .001) and be discharged to a rehabilitation center (OR: 1.60; [95% CI: 1.27-2.00], P < .001) or nursing home (OR: 2.23; [95% CI: 1.64-3.01], P < .001). Five-year survival was lower in octogenarians (83% vs 71%, hazard ratio [HR]: 1.70; [95% CI: 1.46-2.0], P < .0001). Multivariate Cox proportional hazard analysis demonstrated that age was associated with increased all-cause mortality (HR: 1.72, [95% CI: 1.39-2.12], P < .001) and aortic-specific mortality (HR: 1.92, [95% CI: 1.04-3.68], P = .038). Crawford extent II aortic disease was associated with an increase in all-cause mortality (HR 1.49; [95% CI: 1.01-2.19], P < .001), aortic-specific mortality (HR: 5.05; [95% CI: 1.35-18.9], P = .016), and aortic-specific reintervention (HR: 1.91; [95% CI: 1.24-2.93], P = .003). Functional dependence was associated with increased all-cause mortality (HR: 2.90; [95% CI: 1.87-4.51], P < .001) and aortic-specific mortality (HR: 4.93; [95% CI: 1.69-14.4], P = .004). CONCLUSIONS: Our findings suggest that octogenarians do have a mildly increased mortality rate and rate of adverse events after F/BEVAR procedures. Despite this, when adjusted for other risk factors, age is on par with other medical comorbidities and therefore should not be a strict exclusion criterion for F/BEVAR procedures, rather considered in the global context of patient's aortic anatomy, health, and functional status.

Physician-Modified Reversed Iliac Branch Device to Prevent Spinal Cord Ischemia in an Urgent Branched Endovascular Aortic Repair.

PURPOSE: Repair of pararenal aneurysms poses a challenge, especially in an urgent setting. Despite the minimally invasive nature of the fenestrated/branched endovascular aortic repair, the technique may require extensive coverage of the aorta, increasing the risk of spinal cord ischemia. TECHNIQUE: A 68-year-old man was admitted with a rapid enlargement of an asymptomatic juxtarenal aortic aneurysm. A minimally invasive treatment with an off-the-shelf branched endovascular graft was planned. Before completing the aneurysm exclusion, an angiography highlighted a large lumbar artery, potentially significant for the perfusion of the spinal cord collateral network. Owing to this finding and an unsuccessful placement of the cerebrospinal fluid drainage, the procedure was staged and completed 5 days later using a physician-modified iliac branch device (IBD) for the segmental artery. The device was shortened and reversely loaded to obtain a cranially-oriented branch. A balloon-expandable covered stent was used to connect the retrograde branch (8 mm) to the lumbar artery (4 mm). Pre-discharge computed tomography (CT)-angiography confirmed the vessel patency. No neurological symptoms occurred. CONCLUSION: The use of a reversely-loaded IBD for segmental artery preservation appears feasible and safe. CLINICAL IMPACT: Intraoperative modification of an iliac branch device during an urgent branched endovascular aortic repair enabled preservation of a potentially critical segmental artery, thus reducing the risk of spinal cord ischemia. This adaptive interventional technique may also offer a strategy for preserving other anatomically significant vessels, such as accessory renal arteries, during complex aortic reconstructions in urgent settings.

Multicentre Experience with Novel Bidirectional Double Cuffed Inner Branches for Complex Endovascular Aortic Repair.

OBJECTIVE: This study aimed to report the initial experience with a novel bidirectional double cuff inner branch design for incorporation of renal and mesenteric arteries in patients undergoing fenestrated and branched endovascular aortic repair (F/BEVAR). METHODS: A retrospective review was undertaken of the experience of F/BEVAR with grafts integrating at least one bidirectional double cuffed inner branch implanted at three tertiary aortic centres between March 2022 and June 2023. All consecutive patients were included. Baseline characteristics, operative data, and follow up data were collected. Results were presented as number or median (interquartile range) unless otherwise stated. RESULTS: Thirteen patients (10 male; median age 72 [68, 77] years) had F/BEVAR using a total of 15 bidirectional double cuffed inner branches (30 cuffs). Indications for bidirectional doubled cuffed inner branches included cranial vessel orientation or double renal arteries in four patients each, common coeliomesenteric trunk in three patients, and early renal artery bifurcation, renal artery origin from a false lumen requiring a flexible route for catheterisation, and surplus configuration in one patient each. Twenty three of the 30 cuffs were used, whereas the remaining seven cuffs were intentionally occluded with vascular plugs. Target vessel incorporation was successful in all bidirectional branches. There was one technical failure related to unsuccessful catheterisation of a left renal artery targeted through a unidirectional caudal inner branch. During a median follow up of seven months there were no instances of target vessel instability or re-interventions and two patients died of causes unrelated to the bidirectional branches. CONCLUSION: The results of the use of bidirectional double cuff inner branches are promising, with high technical success and no short term branch related complications in this preliminary experience. This could potentially expand the applicability of branch endografting of complex endovascular aortic repairs, but long term results are still missing.

Techniques and Limitations of Gore Thoracoabdominal Multibranch Endoprosthesis (TAMBE) for Type 1A Endoleak After Failed Endovascular Aortic Repairs.

PURPOSE: Endovascular aortic aneurysm repair (EVAR) is the dominant treatment modality over open repair for abdominal aortic aneurysms. However, a higher rate of reinterventions remains the Achilles heel of EVAR. Although type 1A endoleak from proximal seal zone failure of EVAR remains one of the leading causes for reintervention, fenestrated branched devices suitable for proximal extension of failed EVAR are not widely available in the United States. Gore Thoracoabdominal Multibranch Endoprosthesis (TAMBE) is an off-the-shelf investigational device that provides supraceliac seal by incorporating 4 visceral and renal arteries via preloaded inner branches. CASE REPORT: In this article, we describe 2 cases of type 1A endoleak from previous EVAR devices repaired using TAMBE. Both cases were performed under the Food and Drug Administration (FDA) compassionate use exemption. Considerations on the case planning and implantation techniques of TAMBE specific to previous EVAR devices are reviewed. CONCLUSIONS: Gore TAMBE can be utilized to repair a type 1A endoleak of a previous infrarenal EVAR device. Greater supraceliac coverage necessary for TAMBE relative to the minimal seal zone should be considered when applying this device for a type 1A endoleak. CLINICAL IMPACT: This report demonstrates the feasibility of applying off-the-shelf TAMBE device to treat one of the most common failure modes of EVAR, type1A endoleak.

Treatment of a type Ia endoleak following EVAR using a custom-made inner branch device.

OBJECTIVES: We represent two cases of late proximal type I endoleak following EVAR with aneurysm expansion that were treated with a custom-made graft with inner branches. METHODS: Two patients of 87 and 82 years old were operated by EVAR 6 and 8 years ago for abdominal aortic aneurysm. Both had proximal type I endoleak with aneurysm sac expansion. Open surgery had a high risk, and a proximal aortic extension with a simple aortic cuff was not possible neither because previous EVAR grafts were already at the level of the renal arteries. A custom-made endograft with inner branches was planned as a fenestrated graft was not technically possible. RESULTS: We successfully treated both patients using a custom-made graft with four inner branches from Jotec (Cryolife, Kennesaw, GA). Three months' follow-up CT scan did not show any endoleaks. All target vessels were patent with good conformability of the bridging stents. CONCLUSION: The treatment of proximal type I endoleak using inner branches' endografts is feasible. This novel technology might broaden the indications for complex aortic repair in a group of patients where fenestrated endografts are not possible.

The Impact of the Proctor Assistance for a Safe Learning Curve in the Development of a Complex Aortic Endovascular Program.

INTRODUCTION: Initiating an endovascular aortic program for treatment of complex aortic aneurysms with fenestrated and branched grafts (FB-EVAR) is challenging. Using a Proctor is one option for training and development of the team. However, this approach has not been formally analyzed. The aim of this study was to analyze the learning curve and the effect of the Proctor regarding safety and effectiveness in FB-EVAR. METHODS: A single-center retrospective cohort study was performed, including all consecutive elective patients submitted to FB-EVAR (including both thoraco-abdominal-TAAA and complex abdominal aortic aneurysms-C-AAA) from 2013 to 2021. Patients were divided into 2 groups, the first operated with the Proctor present and the second without. Primary outcomes were 30-day mortality (safety) and technical and procedure success (efficacy). Secondary outcomes included treatment performance (procedure time, blood loss, contrast, and radiation use), re-interventions, aneurysm shrinking, target vessel patency, 30-day mortality, aneurysm-related mortality, and overall mortality. RESULTS: Overall, 105 patients were included in the study, 35 operated with Proctor and 70 operated without. The first 20 patients were operated always with the Proctor, and the remaining were operated with the Proctor selectively. Mean age was 71.8 (±7.3) years and 95 patients were male (90.5%). Overall, 62 (65%) patients had C-AAA or extent IV TAAAs and 43 (35%) had extensive TAAAs. There were no significant differences regarding 30-day mortality (Log Rank=0.99), technical success (p=0.4), or procedure success (p=0.8). Mean surgical time was longer in the non-Proctor group (p=0.005), as well as significant intra-operative blood loss (p=0.042). Contrast use (p=0.5) and radiation (p=0.53) were non-significantly different between groups. There were no significant differences regarding length of stay (p=0.4), major adverse events (p=0.6), target vessel patency (Log Rank=0.97), early (p=0.7) and late endoleaks (0.7), aneurysm shrinking (p=0.6), re-interventions (p=0.2), and overall mortality (Log Rank=0.87). CONCLUSION: In our experience, the use of a Proctor to start and accompany our complex endovascular aortic program for FB-EVAR was both safe and effective and may serve as a template by other countries and centers that aim to developing their programs.

Editor's Choice - Multicentre Outcomes of Redo Fenestrated/Branched Endovascular Aneurysm Repair to Rescue Failed Fenestrated Endografts.

OBJECTIVE: To report the outcomes of redo fenestrated and/or branched endovascular aortic repair (F/BEVAR in FEVAR) to rescue previous failed FEVAR. METHODS: Retrospective review of all consecutive patients undergoing F/BEVAR in FEVAR at eight aortic centres including pre-, intra-, and post-operative data according to a pre-established protocol. Follow up consisted of at least yearly computed tomography angiography. Values are presented as median and interquartile range, and survival as estimate ± standard error in percentage. RESULTS: 18 male patients (76 years old; range 69 - 78 years) receiving FEVAR involving two (two or three) target vessels between 2006 and 2016 underwent F/BEVAR in FEVAR between 2012 and 2019 (aneurysm diameter of 63 mm; range 56 - 69 mm). Median interval between the procedures was 53 (29 - 103) months. The indication for F/BEVAR in FEVAR was type Ia endoleak in 16 cases (eight isolated and eight combined with graft migration), one graft migration without endoleak and one migration with significant proximal aortic expansion. F/BEVAR in FEVAR involved all patent renovisceral arteries and had an operating time of 260 (204 - 344) minutes. Technical success was achieved in 15 (83%) cases. There was a failure to bridge one renal artery, one renal capsular bleed with the subsequent need for renal artery embolisation within 24 hours and one persistent type Ib endoleak despite iliac extension. There was no peri- or in hospital death. Two patients developed spinal cord ischaemia, one transient paraparesis and one permanent paraplegia. The latter occurred in a non-staged procedure where spinal drainage was used. During a follow up of 27 (7 - 39) months, three (17%) patients underwent late re-interventions. Overall survival at 24 months was 70 ± 11% with no aneurysm related death and a secondary clinical success at 24 months of 84 ± 11%. CONCLUSION: F/BEVAR in FEVAR is a technically challenging but feasible solution to rescue failed FEVAR. The outcomes are promising in many aortic centres but need to be confirmed by further studies with longer follow up.

Early Outcomes After Branched and Fenestrated Endovascular Aortic Repair in Octogenarians.

AIM: To compare early outcome after complex endovascular aortic repair in octogenarians (age ≥ 80 years) versus non-octogenarians (age < 80 years) treated with fenestrated or branched stent grafts. METHODS: Single centre retrospective analysis from a prospectively collected database of all patients undergoing repair with fenestrated or branched stent grafts for para/suprarenal aortic aneurysm, type Ia endoleak after previous endovascular aortic repair, and thoraco-abdominal aortic aneurysm between January 2015 and December 2017. Early all cause mortality, major adverse events, and need for re-intervention were analysed for non-octogenarians (age < 80 years) and octogenarians (age ≥ 80 years) at the time of repair. RESULTS: 207 patients (58 [28%] females) with a median age of 73 years (IQR 68-78) underwent repair with fenestrated or branched stent grafts. There were 169 (81%) non-octogenarians with a median age of 72 years (IQR 65-76) and 38 (19%) octogenarians with a median age of 82 years (IQR 81-84). The number of patients with chronic kidney disease was significantly higher in the octogenarians (63 [37%] vs. 22 [58%], p = .03]. Nineteen patients (9%) died. The early mortality rate was higher in the octogenarians (12 [7%] vs. 7 [18%], p = .06]. Mortality rate was 4% (6/148) for elective and 22% (13/59) for urgently treated patients. Similar rates of post-operative sepsis, stroke, respiratory problems, need for dialysis, and spinal cord injury were found in both groups. Two patients in each group had early stent graft related re-interventions. The octogenarian group had increased post-operative creatinine values (1.0 [0.8-1.4] vs. 1.4 [1.0-1.9], p = .01). After multiple logistic regression, ASA class ≥4 and rupture were independent factors of early all cause mortality. CONCLUSIONS: Complex endovascular repair in octogenarians has higher early all cause mortality compared with non-octogenarians. Rupture and higher ASA class of ≥4 are independent predictors for early mortality. Age ≥80 years was found to be an independent predictor for higher early all cause mortality.

Single-center initial experience with inner-branch complex EVAR in 44 patients.

Purpose: The use of inner-branch aortic stent grafts in the treatment of complex aortic pathologies aims at broad applicability and stable bridging stent sealing compared to other endovascular technologies. The objective of this study was to evaluate the early outcomes with a single manufacturer custom-made and off-the-shelf inner-branched endograft in a mixed patient cohort. Methods: This retrospective, monocentric study between 2019 and 2022 included 44 patients treated with inner-branched aortic stent grafts (iBEVAR) as custom-made device (CMD) or off-the-shelf device (E-nside) with at least four inner branches. The primary endpoints were technical and clinical success. Results: Overall, 77% (n = 34) and 23% (n = 10) of the patients (mean age 77 ± 6.5 years, n = 36 male) were treated with a custom-made iBEVAR with at least four inner branches and an off-the-shelf graft, respectively. Treatment indications were thoracoabdominal pathologies in 52.2% (n = 23), complex abdominal aneurysms in 25% (n = 11), and type Ia endoleaks in 22.7% (n = 10). Preoperative spinal catheter placement was performed in 27% (n = 12) of patients. Implantation was entirely percutaneous in 75% (n = 33). Technical success was 100%. Target vessel success manifested at 99% (178/180). There was no in-hospital mortality. Permanent paraplegia developed in 6.8% (n = 3) of patients. The mean follow-up was 12 months (range 0-52 months). Three late deaths (6.8%) occurred, one related to an aortic graft infection. Kaplan-Meier estimated 1-year survival manifested at 95% and branch patency at 98% (177/180). Re-intervention was necessary for a total of six patients (13.6%). Conclusions: Inner-branch aortic stent grafts provide a feasible option for the treatment of complex aortic pathologies, both elective (custom-made) and urgent (off-the-shelf). The technical success rate is high with acceptable short-term outcomes and moderate re-intervention rates comparable to existing platforms. Further follow-up will evaluate long-term outcomes.

Patients' health and quality of life after complex endovascular aortic repair: A prospective cohort study.

RATIONALE: Complex endovascular aortic repair often involves multiple major procedures over time with a high risk of complications and little time for recovery. This exposes patients to great stress, both physically and mentally, with potentially long-lasting effects. There is limited knowledge about these effects and who is most at risk - information on this could help vascular nurses and other healthcare professionals anticipate and meet care needs. AIM: To investigate the health and quality of life effects of complex endovascular aortic repair, in relation to patients' demographic and health characteristics. DESIGN: A prospective cohort study. METHODS: Patients undergoing elective complex endovascular aortic repair were consecutively recruited from one university hospital during one year (n=25). Self-report questionnaires on health disability (WHODAS 2.0), quality of life (WHOQoL-BREF) and symptoms of anxiety and depression (HADS) were filled out preoperatively and repeated one and six months postoperatively. Prospective changes in health and quality of life, and associations with patient demographics and preoperative health characteristics, were assessed. Ethical approval was obtained prior to study performance. RESULTS: Overall, patients had significantly greater health disability at one month (WHODAS 2.0 score median 31.5, range 1.1-63.0) than preoperatively (median 13.6, range 0.0-41.3) (n=22, p=.017); the majority had recovered at six months (median 11.4, range 3.3-58.7) (n=18, p=.042). No significant effects were seen in quality of life and symptoms of anxiety and depression (p>.05). However, the participants showed heterogeneity, with certain individuals not recovered at six months (n=8). Factors associated with worse six-month outcomes were being female, age < 70 years, postoperative complications, and history of anxiety or depression. CONCLUSIONS: Complex endovascular aortic repair have limited long-term negative effects on patients' health and quality of life. However, some patients are not recovered at six months postoperatively, which could be explained by individual characteristics. To improve recovery outcomes, vascular nurses and other health care professionals should be aware of the possible recovery trajectories and factors associated with impaired recovery, and use them to anticipate and meet the patients' individual care needs.

A scoping review on the approaches for cannulation of reno-visceral target vessels during complex endovascular aortic repair.

OBJECTIVES: The aim of this study was to assess the approaches to reno-visceral target vessels (TVs) cannulation during branched-fenestrated endovascular aortic repair, determine the evidence base that links these approaches to clinical outcomes and identify literature gaps. METHODS: A scoping review following the PRISMA Protocols Extension for Scoping Reviews was performed. Available full-text studies published in English (PubMed, Cochrane and EMBASE databases; last queried, 31 June 2022) were systematically reviewed and analysed. Data were reported as descriptive narrative or tables, without any statistical analysis nor quality assessment. RESULTS: Fourteen retrospective articles were included. Seven articles studied the use of upper extremity access (UEA) during branched-fenestrated endovascular aortic repair, 3 studied the use of steerable sheaths and 4 included both approaches. A left UEA was used in 757 patients (technical success: 99%, stroke rate: 1-3%) and a right UEA in 215 patients (technical success: 92-98%, stroke rate: 0-13%). Seven studies (1066 patients) described a surgical access only (technical success: 80-99%, stroke rate: 0-13%), while 3 studies (146 patients) described a percutaneous access only (technical success: 83-90%, stroke rate: 3%) and lastly 4 studies compared UEA versus use of steerable sheaths from the transfemoral approach (TFA) (UEA: 563 patients, technical success: 95-98%, stroke rate: 1-8%; TFA: 209 patients, technical success: 98-100%, stroke rate: 0-1%). CONCLUSIONS: Both UEA and TFA as cannulation approaches were associated with high technical success and low perioperative complications. Currently, there is a paucity of high-quality data to provide definitive indication. Optimal UEA in terms of side (left versus right) and approach (surgical versus percutaneous) needs further study.