Complex Abdominal Aortic Aneurysms Research Articles

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

BackgroundEarly 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. MethodsThe 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. ResultsA 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. ConclusionsThis 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.

Protagoras 3.0: feasibility of current fenestrated endografts and chimney technique for complex abdominal aortic aneurysms.

The aim of this study was to evaluate the anatomical feasibility of current available fenestrated endografts (FEVAR) and on-label chimney technique (EnChEVAR) in patients with complex abdominal aortic aneurysms (C-AAA). Feasibility of EnChEVAR (Endurant II/IIS CE-marked [Medtronic]) and 4 types of FEVAR (Zenith Fenestrated CE-marked, Zenith Fenestrated Low-Profile [LP] custom-made device [CMD] [Cook Medical], Fenestrated Anaconda LoPro90 CMD, Fenestrated Treo CMD [Terumo Aortic]) was assessed according to the manufacturer's instructions for use. Computed tomography angiograms of patients with C-AAA previously included in the Protagoras 2.0 study were retrospectively reviewed. The aortic coverage was ideally planned to involve a maximum of two chimney grafts or fenestrations. Iliac access and aortic neck of 73 C-AAAs were analyzed. The overall feasibility was significantly different between EnChEVAR (33%) and FEVAR (Zenith Fenestrated 15%, Zenith Fenestrated LP 15%, Fenestrated Anaconda LoPro90 45%, Fenestrated Treo 48%). The iliac access feasibility was significantly lower for Zenith Fenestrated with standard profile compared to all other grafts. The aortic neck feasibility was significantly higher for EnChEVAR and both Terumo Aortic fenestrated stent grafts, compared to both Cook Medical grafts. The treatment using any of the three current available fenestrated grafts with lower profile (Zenith Fenestrated LP, Fenestrated Anaconda LoPro90, Fenestrated Treo) would have been feasible in 71% of the cases. Most of the patients treated by ChEVAR would have not been treated by first generation fenestrated stent graft. The current available fenestrated endografts, with lower profile and suitable also for angulated necks, increase the anatomical feasibility.

The Impact of Target Vessel Anatomy and Bridging Stent Geometry on Branched Endovascular Aortic Repair Outcomes

This study aimed to evaluate the impact of target vessel anatomy and bridging stent geometry on target vessel instability in branched endovascular aortic repair (B-EVAR). This retrospective, single centre cohort study included all consecutive B-EVARs performed between September 2018 and December 2022 for thoraco-abdominal aortic aneurysm (TAAA) or complex abdominal aortic aneurysm (CAAA). The primary endpoints were target vessel instability and related re-interventions at 12 months. Secondary endpoints were 30 day results, including target vessel instability and re-interventions. Target vessel instability analysis consisted of assessment of target vessel anatomy, including diameter, aortic trunk to branch angle, and tortuosity. Post-operative parameters included change of clock position/horizontal misalignment, bridging length (gap), sealing length, tortuosity, post-stenting angle, and oversizing ratio. A total of 69 patients (TAAA: n= 56, 81%; CAAA: n= 13, 19%) and 271 (133 visceral and 138 renal) target vessels were included. The cumulative incidence of target vessel instability was 4.8%, 6.4%, and 7.9% at one, two, and three years, respectively. In the renal target vessel group, vessel diameter ≤ 4 mm (hazard ratio [HR] 1.28, 95% confidence interval [CI] 1.116 - 2.54; p= .022) and a bridging length ≥ 25 mm (HR 1.320, 95% CI 1.066 - 1.636; p= .011) were associated with increased target vessel instability. In visceral vessels, a change in clock position/horizontal misalignment ≥ 70 minutes (HR 1.072, 95% CI 1.026 - 1.121; p= .002) showed a significant association with target vessel instability. Target vessel diameter, bridging length (gap), and horizontal misalignment seemed to be associated with adverse target vessel outcomes. This may be solved with more customised endograft solutions to reduce the negative impact of the latter parameter.

The "Bundle Wire" Technique: A Novel Approach to Cannulating Challenging Target Vessels Using Multiple Fine Atraumatic Guidewires That Together Serve as a Stiff Guidewire.

To present a novel technique that enables safe and effective cannulation of target vessels with challenging anatomy during fenestrated/branched endovascular aortic repair (F/B-EVAR). Following deployment of the F/B-EVAR endograft, the target vessels (TVs) are cannulated. The bundle wire technique provides a solution to challenging TVs and uses multiple fine atraumatic guidewires that together serve as a stiff guidewire. The technique can be executed in 2 ways using: (1) one 0.018 inch and one 0.014 inch guidewire or (2) three 0.014 inch guidewires. We demonstrate the technique in a case of a complex abdominal aortic aneurysm treated using branched EVAR in which the left renal artery with severe ostial stenosis was catheterized using the bundle wire technique. The bundle wire technique offers a technically feasible and economically viable solution for facilitating catheter and bridging stent delivery in anatomically challenging TVs during F/B-EVAR. It is a useful addition to the therapeutic armamentarium available to physicians for accessing demanding TVs.

Long-term outcomes of chimney endovascular aneurysm repair procedure for complex abdominal aortic pathologies

ObjectiveThe aim of this study was to update our earlier experience and to evaluate long-term outcomes of chimney endovascular aortic repair performed for selected cases with complex abdominal aortic aneurysm. MethodsA single-center retrospective cohort study was conducted on 51 consecutive patients who underwent chimney endovascular aortic repair procedure, deemed unfit for open surgical repair and fenestrated endovascular aneurysm repair, from October 2009 to November 2019. Kaplan-Meier analyses were used to assess the estimated overall survival, freedom from aneurysm related mortality, freedom from reintervention, freedom from target vessel instability, and freedom from type Ia endoleaks. ResultsFifty-one patients (mean age, 77.1 ± 7.5 years) with a mean preoperative maximum aneurysm diameter of 74.2 ± 20.1 mm were included. Mean follow-up duration was 48.6 months (range, 0-136 months). Estimated overall survival at 5 and 7 years was 36.3% ± 7.1% and 18.3% ± 6.0%, respectively. Freedom from aneurysm-related mortality was 88.6% ± 4.9% at 7 years. Estimated freedom from type Ia endoleaks at 7 years was 91.8% ± 3.9%. A total of 21 late reinterventions were performed in 17 patients (33%). Most of them were performed to treat type II endoleaks with sac growth (47.6%; n = 10) and type Ib endoleak (23.8%; n = 5). Estimated freedom from reintervention at 7 years was 56.3% ± 7.9%. Estimated freedom from target vessel instability at 7 years was 91.5% ± 4.1%. ConclusionsThe 7-year results of chimney endovascular aortic repair procedures performed in our center confirm the long-term safety and effectiveness of this technique in a series of high-risk patients with large aneurysms. The present study has, to the best of our knowledge, the longest follow-up for patients treated with chimney endovascular aortic repair, and it provides data to the scarce literature on the long-term outcomes of this procedure, showing acceptable to good long-term results.

Standardized approach for four-fenestrated physician-modified endograft to treat complex abdominal aortic aneurysms using Valiant Captivia

We describe the feasibility and safety of a standardized approach for four-fenestrated physician-modified endograft (PMEG) placement to treat complex abdominal aortic aneurysms using the Valiant Captivia platform (Medtronic). The standardization is based on specific selection criteria for anatomical feasibility, measurement method, and modification technique of a single endograft type. Six cases (two juxtarenal, two pararenal, and two type IV thoracoabdominal aneurysms) were treated, with 24 target vessels incorporated with fenestrations. Four cases were treated in an urgent setting and two were elective. The time modification required was 121 ± 18 minutes. Technical success was 100%, with no mortality or complications at 30 days. Postoperative computed tomography at 3 months demonstrated complete aneurysm exclusion, without a type I or III endoleak, no main graft- or fenestration-related loss of integrity, and no target vessel misalignment or stent fracture. The present standardized approach seems safe and feasible and might represent an initial benchmark for comparison with future studies.

Impact of Active Smoking in Perioperative Outcomes of Patients Undergoing FB-EVAR for Thoracoabdominal and Complex Abdominal Aortic Aneurysms

Impact of Active Smoking in Perioperative Outcomes of Patients Undergoing FB-EVAR for Thoracoabdominal and Complex Abdominal Aortic Aneurysms

Long-term costs to Medicare associated with endovascular and open repairs of infrarenal and complex abdominal aortic aneurysms

ObjectiveThe vast majority of patients with abdominal aortic aneurysms (AAAs) undergoing repairs receive endovascular interventions (EVARs) instead of open operations (OARs). Although EVARs have better short-term outcomes, OARs have improved longer-term durability and require less radiographic follow-up and monitoring, which may have significant implications on health care economics surrounding provision of AAA care nationally. Herein, we compared costs associated with EVAR and OAR of both infrarenal and complex AAAs. MethodsWe examined patients undergoing index elective EVARs or OARs of infrarenal and complex AAAs in the 2014-2019 Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Network (VQI-VISION) dataset. We defined overall costs as the aggregated longitudinal costs associated with: (1) the index surgery; (2) reinterventions; and (3) imaging tests. We evaluated overall costs up to 5 years after infrarenal AAA repair and 3 years for complex AAA repair. Multivariable regressions adjusted for case-mix when evaluating cost differences between EVARs vs OARs. ResultsWe identified 23,746 infrarenal AAA repairs (8.7% OAR, 91% EVAR) and 2279 complex AAA repairs (69% OAR, 31% EVAR). In both cohorts, patients undergoing EVARs were more likely to be older and have more comorbidities. The cost for the index procedure for EVARs relative to OARs was lower for infrarenal AAAs ($32,440 vs $37,488; P < .01) but higher among complex AAAs ($48,870 vs $44,530; P < .01). EVARs had higher annual imaging and reintervention costs during each of the 5 postoperative years for infrarenal aneurysms and the 3 postoperative years for complex aneurysms. Among patients undergoing infrarenal AAA repairs who survived 5 years, the total 5-year cost of EVARs was similar to that of OARs ($35,858 vs $34,212; −$223 [95% confidence interval (CI), −$3042 to $2596]). For complex AAA repairs, the total cost at 3 years of EVARs was greater than OARs ($64,492 vs $42,212; +$9860 [95% CI, $5835-$13,885]). For patients receiving EVARs for complex aneurysms, physician-modified endovascular grafts had higher index procedure costs ($55,835 vs $47,064; P < .01) although similar total costs on adjusted analyses (+$1856 [95% CI, −$7997 to $11,710]; P = .70) relative to Zenith fenestrated endovascular grafts among those that were alive at 3 years. ConclusionsLonger-term costs associated with EVARs are lower for infrarenal AAAs but higher for complex AAAs relative to OARs, driven by reintervention and imaging costs. Further analyses to characterize the financial viability of EVARs for both infrarenal and complex AAAs should evaluate hospital margins and anticipated changes in costs of devices.

Outcome of the Be Graft Bridging Stent in Fenestrated Endovascular Aortic Repair in a High-Volume Single Center and an Overview of Current Evidence.

Fenestrated endovascular aneurysm repair (FEVAR) has become one of the standard treatment options for complex abdominal aortic aneurysms (cAAAs) and thoraco-abdominal aortic aneurysms (TAAAs). Despite technological advances in the main endograft design, the lack of dedicated bridging stent-grafts (BSGs) is still the Achilles heel of the procedure. The aim of this study was to evaluate the mid-term outcomes of the BeGraft stent-graft as a dedicated bridging stent for FEVAR and to review the current evidence in literature. Retrospective single center study, including all consecutive FEVARs performed between September 2018 and December 2022 for the treatment of cAAAs and TAAAs with implantation of at least one BeGraft peripheral as the main BSG in one of the target vessels (TVs). Primary endpoints were technical success and TV instability of TV bridged with a BeGraft stent, as well as 30-day mortality and re-intervention rates. Secondary endpoints were follow-up TV instability, re-interventions, and mortality. A total of 113 patients (93 male, mean age 71.1±9.7) and 440 TV (14 scallops and 426 fenestrations) were included. Of the 440 TV, 406 received primary stenting. Be Grafts were used in 88.9% of these (n=361; celiac trunk [CT]=67, superior mesenteric artery [SMA]=98, right renal artery [RRA]=97, and left renal artery [LRA]=99). The technical success rate was 99.4% (359/361). The 30-day TV instability rate was 0.27% (1/361) with one early renal artery occlusion. During a median follow-up of 20 months (6-32), TV instability rate was 0.8% (3/361). Freedom from TV instability was 99.3%, 98.8%, and 98.8% at 1, 2, and 3 years, respectively. Early-term and mid-term results regarding TV instability are satisfactory and support the use of BeGraft as BSG in FEVAR for cAAAs and TAAAs. The findings of the current study show that the use of the BeGraft stent graft as bridging stent in FEVAR is associated with a high technical success and low early and mid-term instability rate and support the standard use as a bridging stent in fenestrated aneurysm repair.

National trends in utilization of surgeon-modified grafts for complex and thoracoabdominal aortic aneurysms

IntroductionCustom-branched/fenestrated grafts are widely available in other countries, but in the United States, they are limited to a handful of centers, with the exception of a 3-vessel juxtarenal device (ZFEN). Consequently, many surgeons have turned to alternative strategies such as physician-modified endografts (PMEGs). We therefore sought to determine how widespread the use of these grafts is. MethodsWe studied all complex endovascular repairs of complex and thoracoabdominal aortic aneurysms in the Vascular Quality Initiative from 2014 to 2022 to examine temporal trends. ResultsA total of 5826 repairs were performed during the study period: 1895 ZFEN, 3241 PMEG, 595 parallel grafting, and 95 where parallel grafting was used in addition to ZFEN, with a mean of 2.7 ± 0.98 vessels incorporated. Over time, the number of PMEGs steadily increased, both overall and for juxtarenal aneurysms, whereas the number of ZFENs essentially leveled off by 2017 and has remained steady ever since. In the most recent complete year (2021), PMEGs outnumbered ZFENs by over 2:1 overall (567 to 256) and nearly twofold for juxtarenal repairs. In three-vessel cases involving juxtarenal aneurysms, PMEGs were used as frequently as ZFENs (43% vs 43%), whereas the proportion of juxtarenal aneurysms repaired using a four-vessel graft configuration increased from 20% in 2014 to 29% in 2021 (P < .001). The differences in PMEG use were more pronounced as surgeon volume increased. Surgeons in the lowest quartile of volume performed <2 complex repairs annually, evenly split between PMEGs and ZFENs. However, surgeons in the highest quartile of volume performed a median of 18 (interquartile range: 10-21) PMEGs/y, but only 1.6 (interquartile range: 0.8-3.4) ZFENs/y. The number of physician-sponsored investigational device exemption trials of PMEGs has expanded from 1 in 2012 to 8 currently enrolling. As those data are not included in the Vascular Quality Initiative, the true number of PMEGs is likely substantially higher. ConclusionsPMEGs have become the dominant endovascular repair modality of complex abdominal and thoracoabdominal aortic aneurysms outside of investigational device exemptions. The field of endovascular aortic surgery and patients with complex aneurysms would benefit from broader publication of PMEG techniques, outcomes, and comparisons to custom-manufactured grafts.

Midterm Outcomes and Aneurysm Sac Dynamics Following Fenestrated Endovascular Aneurysm Repair after Previous Endovascular Aneurysm Repair

Fenestrated endovascular aneurysm repair (FEVAR) represents a feasible option for aortic repair after endovascular aneurysm repair (EVAR), due to improved peri-operative outcomes compared with open conversion. However, little is known regarding the durability of FEVAR as treatment of failed EVARs. Since aneurysm sac evolution is an important marker for success after aneurysm repair, the aim of the study was to examine mid-term outcomes and aneurysm sac dynamics of FEVAR after prior EVAR. Patients undergoing FEVAR for complex abdominal aortic aneurysms from 2008 to 2021 at two hospitals in The Netherlands were included. Patients were categorised into primary FEVAR and FEVAR after EVAR. Outcomes included five year mortality, one year aneurysm sac dynamics (regression/stable/expansion), sac dynamics over time, and five year aortic related procedures. Analyses were done using Kaplan-Meier methods, multivariable Cox regression analysis, chi-square tests, and linear mixed effect models. In total, 196 patients with FEVAR were identified, of whom 27% (n = 53) had a prior EVAR. Patients with prior EVAR were significantly older (78 ± 6.7 years vs. 73 ± 5.9 years, p < .001). There were no significant differences in mortality. FEVAR after EVAR was associated with higher risk of aortic related procedures within five years (hazard ratio [HR] 2.6; 95% confidence interval [CI] 1.1 - 6.5, p = .037). Sac dynamics were assessed in 154 patients with available imaging. Patients with a prior EVAR showed lower rates of sac regression and higher rates of sac expansion at one year compared with primary FEVAR (sac expansion 48%, n = 21/44, vs. 8%, n = 9/110, p < .001)). Sac dynamics over time showed similar results, sac growth for FEVAR after EVAR, and sac shrinkage for primary FEVAR (p < .001). FEVAR after EVAR showed high rates of sac expansion and needed more secondary procedures than patients with primary FEVAR, although this did not affect mid-term survival. Future studies will have to assess whether FEVAR after EVAR is a valid intervention, and the underlying process that drives aneurysm sac growth following successful FEVAR after EVAR.

Complex abdominal aortic aneurysms: a review of radiological and clinical assessment, endovascular interventions, and current evidence of management outcomes.

Endovascular aortic aneurysm repair (EVAR) is an established approach to treating abdominal aortic aneurysms, however, challenges arise when the aneurysm involves visceral branches with insufficient normal segment of the aorta to provide aneurysm seal without excluding those vessels. To overcome this, a range of technological developments and solutions have been proposed including fenestrated, branched, physician-modified stents, and chimney techniques. Understanding the currently available evidence for each option is essential to select the most suitable procedure for each patient. Overall, the evidence for fenestrated endovascular repair is the most comprehensive of these techniques and shows an early post-operative advantage over open surgical repair (OSR) but with a catch-up mortality in the mid-term period. In this review, we will describe these endovascular options, pre- and post-procedure radiological assessment and current evidence of outcomes.

Midterm outcomes of physician-modified endovascular stent grafts for the treatment of complex abdominal aortic aneurysms in Korea: a retrospective study.

Physician-modified endovascular stent grafts (PMEG) are a good treatment option for complex abdominal aortic aneurysms (AAAs), especially in high-risk patients not amenable to open repair, and when commercial fenestrated devices are not available. We report our single-center experience with PMEG for the treatment of complex AAAs. We retrospectively reviewed patients who underwent PMEG repair for AAA from November 2016 to September 2020 at our institution. Demographic data, anatomic characteristics, perioperative and postoperative outcomes, major adverse events, and 30-day mortality were analyzed. We identified 12 patients who underwent PMEG for complex AAA. The mean age was 74 years and the mean maximal AAA diameter was 58.1 mm. Indications for treatment included 4 impending or contained ruptures, 2 mycotic aneurysms, and 6 symptomatic cases. The technical success rate was 91.7%. Aneurysm sac regression was observed in 7 patients (58.3%), including 2 cases of complete regression. There was 1 aneurysm-related mortality at 3 months due to mycotic aneurysm. Also, there was 1 postoperative complication case of transient renal failure requiring temporary dialysis. At 1 year, there was 1 branch occlusion from the initial failed cannulation case and 2 type 1A endoleaks, and there was 1 case of open explantation. PMEG showed a low technical failure rate and acceptable midterm stent durability and sac stability, comparable to conventional endovascular aneurysm repair. Despite the small number of cases, there was a tendency for a high sac regression rate, although longer follow-up is needed.

Prospective evaluation of upper extremity access and total transfemoral approach during fenestrated and branched endovascular repair

ObjectiveTotal transfemoral (TF) access has been increasingly used during fenestrated-branched endovascular aortic repair (FB-EVAR). However, it is unclear whether the potential decrease in the risk of cerebrovascular events is offset by increased procedural difficulties and other complications. The aim of this study was to compare outcomes of FB-EVAR using a TF vs upper extremity (UE) approach for target artery incorporation. MethodsWe analyzed the clinical data of consecutive patients enrolled in a prospective, nonrandomized clinical trial in two centers to investigate the use of FB-EVAR for treatment of complex abdominal aortic aneurysms (CAAA) and thoracoabdominal aortic aneurysms (TAAA) between 2013 and 2022. Patients were classified into TF or UE access group with a subset analysis of patients treated using designs with directional branches. End points were technical success, procedural metrics, 30-day cerebrovascular events defined as stroke or transient ischemic attack, and any major adverse events (MAEs). ResultsThere were 541 patients (70% males; mean age, 74 ± 8 years) treated by FB-EVAR with 2107 renal-mesenteric TAs incorporated. TF was used in175 patients (32%) and UE in 366 patients (68%) including 146 (83%) TF and 314 (86%) UE access patients who had four or more TAs incorporated. The use of a TF approach increased from 8% between 2013 and 2017 to 31% between 2018 and 2020 and 96% between 2021 and 2022. Compared with UE access patients, TF access patients were more likely to have CAAAs (37% vs 24%; P = .002) as opposed to TAAAs. Technical success rate was 96% in both groups (P = .96). The use of the TF approach was associated with reduced fluoroscopy time and procedural time (each P < .05). The 30-day mortality rate was 0.6% for TF and 1.4% for UE (P = .67). There was no early cerebrovascular event in the TF group, but the incidence was 2.7% for UE patients (P = .035). The incidence of MAEs was also lower in the TF group (9% vs 18%; P = .006). Among 237 patients treated using devices with directional branches, there were no significant differences in outcomes except for a reduced procedural time for TF compared with UE access patients (P < .001). ConclusionsTF access was associated with a decreased incidence of early cerebrovascular events and MAEs compared with UE access for target artery incorporation. Procedural time was decreased in TF access patients irrespective of the type of stent graft design.

Preoperative predictors of nonhome discharge after fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms

BackgroundNonhome discharge (NHD) has significant implications for patient counseling and discharge planning and is frequently required following fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms (CAAA) and thoracoabdominal aortic aneurysms (TAAA). We aimed to identify preoperative predictors of NHD after elective FB-EVAR for CAAA and TAAA and develop a risk calculator able to predict NHD. MethodsA retrospective review of prospectively collected data on all patients undergoing FB-EVAR between January 2007 and December 2021 at a single institution was performed. Exclusion criteria were admission from a nonhome setting, emergency and repeat FB-EVAR, and discharge to an unknown destination. The cohort was randomly split into separate development (70% of patients) and validation (30%) cohorts to develop a predictive calculator for NHD. Independent variables associated with NHD were assessed in a series of logistic regression analyses from 100 bootstrapped samples of the development set, and a model was developed using the most predictive variables. Resulting parameter estimates were applied to data in the validation set to assess model discrimination and calibration. ResultsFrom the initial cohort of 712 FB-EVAR patients, 644 were included in the study (74% male; mean age, 75.4 ± 7.6 years), including 452 with CAAA (70%) and 192 with TAAA (30%). Early mortality occurred in eight patients (1.2%; 5 in CAAA and 3 in TAAA) and the median hospital stay was 5 days (4 for CAAA and 7 for TAAA). Ninety-seven patients (15%) had a NHD. On multivariable analysis, older age (per year, odds ratio [OR], 1.08; P < .001), female gender (OR, 3.03; P < .001), smoking (OR, 2.86; P = .01), congestive heart failure (OR, 3.05; P = .004), peripheral artery disease (OR, 1.81; P = .07), and extent I (OR, 3.17), II (OR, 2.84), and III (OR, 2.52; all P = .08) TAAAs were associated with an increased likelihood of NHD in the development set. Based on these factors, the risk calculator was developed which accurately predicts NHD in the validation set with an area under the curve of 0.7. ConclusionsOlder, female smokers with congestive heart failure and peripheral artery disease and more extensive aneurysms are at highest risk of NHD after FB-EVAR. Using only preoperative factors, our risk calculator can predict accurately who will have a NHD, allowing enhanced preoperative patient counselling and accelerated hospital discharge.

Renal and Visceral Artery Configuration During the First Year of Follow-Up After Fenestrated Aortic Aneurysm Repair Using the Anaconda Stent-graft: A Prospective Longitudinal Multicenter Study With ECG-Gated CTA Scans.

The performance of fenestrated endovascular aortic aneurysm repair (FEVAR) may be compromised by complications related to the dynamic vascular environment. The aim of this study was to analyze the behavior of FEVAR bridging stent configurations during the cardiac cycle and during follow-up to improve our understanding on treatment durability. Twenty-one patients presenting with complex abdominal aortic aneurysms (AAAs; 9 juxtarenal/6 pararenal/3 paravisceral/1 thoracoabdominal aortic aneurysm type IV), treated with a fenestrated Anaconda (Terumo Aortic, Inchinnan, Scotland, UK) with Advanta V12 bridging stents (Getinge, Merrimack, NH, USA), were prospectively enrolled in a multicenter observational cohort study and underwent electrocardiogram (ECG)-gated computed tomographic angiography (CTA) preoperatively, at discharge, 7-week, and 12-month follow-ups. Fenestrated endovascular aortic aneurysm repair stability was assessed considering the following variables: branch angle as the angle between the aorta and the target artery, end-stent angle as the angle between the end of the bridging stent and the native artery downstream from it, curvature and tortuosity index (TI) to describe the bending of the target artery. Body-bridging stent stability was assessed considering bridging stent flare lengths, the distances between the proximal sealing stent-ring and fenestrations and the distance between the fenestration and first apposition in the target artery. Renal branch angles significantly increased after FEVAR toward a perpendicular position (right renal artery from median 60.9°, inter quartile range [IQR]=44.2-84.9° preoperatively to 94.4°, IQR=72.6-99.8°, p=0.001 at 12-month follow-up; left renal artery [LRA], from 63.7°, IQR=55.0-73.0° to 94.3°, IQR=68.2-105.6°, p<0.001), while visceral branch angles did not. The mean dynamic curvature only decreased for the LRA from preoperative (3.0, IQR=2.2-3.8 m-1) to 12-month follow-up (1.9, IQR=1.4-2.6 m-1, p=0.027). The remaining investigated variables did not seem to show any changes over time in this cohort. Fenestrated endovascular aortic aneurysm repair for complex AAAs using the Anaconda fenestrated stent-graft and balloon-expandable Advanta V12 bridging stents demonstrated stable configurations up to 12-month follow-up, except for increasing renal branch angles toward perpendicular orientation to the aorta, yet without apparent clinical consequences in this cohort. This study provides detailed information on the cardiac-pulsatility-induced (dynamic) and longitudinal geometry deformations of the target arteries and bridging stents after fenestrated endovascular aortic aneurysm repair (FEVAR) up to 12-month follow-up. The configuration demonstrated limited dynamic and longitudinal deformations in terms of branch angle, end-stent angle, curvature, and tortuosity index (TI), except for the increasing renal branch angles that go toward a perpendicular orientation to the aorta. Overall, the results suggest that the investigated FEVAR configurations are stable and durable, though careful consideration of increasing renal branch angles and significant geometry alterations is advised.

Prospective assessment of dynamic changes in frailty and its impact on early clinical outcomes following physician-modified fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms

IntroductionFrailty, a predictor of poor outcomes, has been widely studied as a screening tool in surgical decision-making. However, the impact of frailty on the outcomes after fenestrated-branched endovascular aortic repairs (FBEVARs) is less well established. In addition, the changes in frailty during recovery after FBEVAR are unknown. We aim to assess the impact of frailty on outcomes of high-risk patients undergoing physician-modified FBEVARs for complex abdominal and thoracoabdominal aortic aneurysms, as well as the changes in frailty during follow-up. MethodsConsecutive patients enrolled in a single-center prospective Physician-Sponsored Investigational Device Exemption protocol (FDA# G200159) were evaluated. In addition to the baseline characteristics, frailty was assessed using the Hopkins Frailty Score (HFS) and frailty index (FI) measured by the Frailty Meter. Sarcopenia was measured by L3 total psoas muscle area (PMA). These measurements were repeated during follow-up. The follow-up HFS and FI were compared with baseline scores using the Wilcoxon signed-rank test, whereas follow-up PMA measurements were compared with the baseline using the paired t test. The association between baseline frailty and morbidity was evaluated by the Wilcoxon rank-sum test. ResultsSeventy patients were analyzed in a prospective Physician-Sponsored Investigational Device Exemption study from February 9, 2021, to June 2, 2023. At baseline, HFS identified 54% of patients as not frail, 43% as intermediately frail, and 3% as frail. Technical success of FBEVAR was 94% with one in-hospital mortality. Early major adverse events were seen in 10 (14.3%) patients. No difference in baseline FI was seen between patients with early morbidity and those without. Patients who were not frail per HFS were less likely to experience early morbidity (P = .033), and there was a significantly lower baseline PMA in patients who experienced early morbidity (P = .016). At 1 month, patients experienced a significant increase in HFS and HFS category (P = .001 and P = .01) and a significant decrease in sarcopenia (mean PMA: −96 mm2, P = .005). At 6 months, HFS and HFS category as well as PMA returned toward baseline (P = .42, P = .38, and mean PMA: +4 mm2, P = .6). ConclusionsPreoperative frailty and sarcopenia were associated with early morbidity after physician-modified FBEVAR. During follow-up, patients became more frail and sarcopenic by 1 month. Recovery from this initial decline was seen by 6 months, suggesting that frailty and sarcopenia are reversible processes rather than a unidirectional phenomenon of continued decline.

Two-Year Results on Real-World Fenestrated or Branched Endovascular Repair for Complex Aortic Abdominal Aneurysm in France.

To describe and compare mid-term outcomes from 2 real-world data collection efforts on fenestrated and branched endovascular aortic repair (fbEVAR) for complex abdominal aortic aneurysms (AAAs) in France and to evaluate the potential of health care databases for long-term post-market surveillance (PMS) and continued reimbursement approval. Two real-world studies were conducted in France: a retrospective health care database study (SNDS) and a prospective clinical study. In the SNDS study, data from implantation and/or hospital stays occurring during follow-up were extracted for all patients treated with the study devices from April 2012 to December 2018. In the clinical study, high-risk patients undergoing fbEVAR with the study devices were enrolled consecutively at 15 sites in France from December 2016 to November 2018. Data from 1073 patients were extracted from SNDS and compared with analogous variables from 186 patients in the clinical study. Most demographic details were similar between studies (SNDS vs clinical: mean age, 71.9 vs 71.8 years; men, 91.0% vs 89.8%), as was 30-day mortality (SNDS: 5.5%, clinical: 4.3%). Patients received custom-made fenestrated or branched devices (SNDS: 80.7%, clinical: 96.2%) or CE-marked Zenith Fenestrated devices (SNDS: 19.3%, clinical: 3.8%). Initial or technical success was above 94% for both studies. Two-year freedom from all-cause mortality was 80.0% (SNDS) and 85.1% (clinical study). Two-year freedom from aneurysm-related mortality was 93.8% (SNDS) and 94.6% (clinical study). Detailed imaging outcomes were not captured within SNDS; however, information on secondary procedures to restore patency was available and used as a surrogate measure for secondary interventions. Two-year freedom from secondary interventions was 73% for the SNDS study. In the clinical study, at 2 years, aneurysm stability or shrinkage was observed in 92.3% of patients, freedom from target vessel primary patency loss was above 95% for all visceral target vessels, and freedom from secondary interventions was 79.1%. Real-world outcomes from the SNDS and clinical study suggest positive mid-term outcomes in high-risk populations following fbEVAR for complex AAAs. The similarities between these studies suggest that the use of health care databases may be an alternative to prospective clinical studies for long-term follow-up and PMS. Positive results following endovascular repair of complex abdominal aortic aneurysms are observed from data extracted from both the French health care database and a post-market clinical study despite initial high-risk patient status and diverse center experience. These outcomes parallel more rigorously designed studies and suggest that with careful study design, real-world data collections have high translatable value to add to the clinical understanding of fenestrated and branched endovascular aortic repair (fbEVAR).

Integration of a Custom-Made Fenestration to Simplify Acute Reno-Visceral In Situ Aortic Repair.

To illustrate the technique of antegrade in situ laser fenestration (ISLF) on a predesign custom-manufactured stent-graft with single reinforced fenestration for use in emergency endovascular repair of complex abdominal aortic aneurysms (AAAs). A short custom-made device (CMD) fenestrated graft was predesigned with a single preloaded 8 mm strut-free fenestration at 12 o'clock position. A modified preloaded system was used to allow unilateral access from the distal port if necessary. After bilateral percutaneous femoral access, the graft was deployed under fusion guidance with the CMD fenestration matching the superior mesenteric artery (SMA) origin and immediately bridged as per standard technique. The aneurysm was then excluded with a bifurcated device. A large steerable sheath was used to allow for sequential antegrade laser in situ fenestration and stenting of the renal arteries. Single-vessel customized short fenestrated grafts for the SMA and antegrade in situ laser renal fenestrations are technically feasible for repair of acute complex AAAs even after previous infrarenal reconstruction. It could become an off-the-shelf solution to limit aortic coverage and reno-visceral ischemia, even in patients with a narrow aortic diameter at the renal level. Single-vessel precustomized short fenestrated grafts for the SMA combined with renal artery antegrade ISLF can be a feasible option for the acute repair of patients with complex aneurysms and a narrow aortic diameter at the reno-visceral segment. It may limit aortic coverage and reno-visceral ischemic time and also be applicable after previous infrarenal endovascular aneurysm repair (EVAR).

Treatment of complex abdominal aortic aneurysms: The ORFEVAR study

Treatment of complex abdominal aortic aneurysms: The ORFEVAR study