Aneurysm Sac Regression Research Articles

TREO Aortic Endograft Demonstrates Superior Aneurysmal Sac Regression Over Mid-Term Follow-Up

IntroductionAneurysmal sac regression is a predictor of long-term outcomes after endovascular aneurysm repair (EVAR). This study aimed to compare a large cohort of TREO and non-TREO endografts over a mid-term follow-up and compare abdominal aortic aneurysm sac regression. The hypothesis was that TREO endografts have an increased sac regression by 24 mo. MethodsThis is a retrospective analysis of all EVARs completed at a single institution between 2015 and 2024. Clinical and imaging data were collected from an institutional database and patients’ records. The analysis included all TREO and age, sex, anticoagulation use and current smoking-matched non-TREO endografts that satisfied anatomic indications for use of the TREO graft. The primary outcomes were sac regression at 12 and 24 mo, and secondary outcomes were rates of mortality, endoleak, and reintervention. ResultsTwenty-one TREO grafts were matched to 68 non-TREO grafts. The groups were similar in demographics, comorbidities, and preoperative anatomy. Preoperative abdominal aortic aneurysm sac size was larger in the TREO cohort. The mean reduction in sac size in mm was greater in the TREO cohort compared to the non-TREO cohort (−12.6 ± 8.95 versus −7.83 ± 7.74 mm, P = 0.039) over the study period. Cox regression analysis identified the TREO stent graft to be associated with 1-y sac regression (hazard ratio = 2.42, P = 0.019). The incidence of all-cause endoleaks, reintervention, and mortality were similar between cohorts. ConclusionsThese findings suggest that the TREO endograft offers better mid-term outcomes with respect to sac regression with no differences in the incidence of endoleak, mortality, or reintervention.

Sex Related Differences in Perioperative Outcomes after Complex Endovascular Aortic Aneurysm Repair

Prior studies suggest female sex is associated with worse outcomes after complex endovascular aortic aneurysm repair (EVAR) due to anatomic differences. Therefore, we aimed to compare 30-day perioperative and long-term outcomes after complex EVAR by sex. A single-center retrospective review of consecutive elective and emergent complex EVAR with company-manufactured devices, laser fenestration, snorkel/periscope, or octopus technique was performed from 2012-2023. The primary outcome was a composite endpoint of any major adverse event (MAE), new-onset dialysis, or death within 30days. Secondary 30-day technical and long-term outcomes were also assessed. 293 patients (57 females, 19%), mean age 74years, underwent complex EVAR with commercially available Zenith fenestrated endovascular graft (71%), p-Branch (2%), laser fenestration (8%), snorkel/periscope (16%), or octopus (2%) techniques. Females had significantly different aneurysm-related anatomic characteristics compared to males, including smaller aneurysm diameters (58±7.2 vs. 64±13.2mm, P<0.001), more involved aneurysm extent (21.7% vs. 9.8% thoracoabdominal, P=0.04), increased renal artery calcification (43.9% vs. 27.1%, P=0.01), and smaller iliac (7.6±1.3 vs. 8.9±1.8mm, P<0.01). Operative outcomes were similar; however, females had a greater need for adjunctive access conduits (21.1% vs. 10.6%, P=0.04), lower technical success (91.2% vs. 98.3%, P=0.02), and longer median [interquartile range] length of stay (3.0 [4.0] vs. 2.0 [2.5] days, P<0.001). The composite 30-day outcome of any MAE, new dialysis, or death was not significantly different (15.8% females vs. 11.4% males, P=0.37). Technical endpoints including 30-day rates of target artery occlusion and type 1 or 3 endoleak were also similar between groups. At mean follow-up of nearly 3years, females had significantly lower rate of renal function decline (16.0% vs. 41.9%, P<0.001), but no differences were found in long-term all-cause mortality, aneurysm sac regression, reintervention, or total follow-up imaging studies between groups. Females undergoing complex EVAR had challenging anatomy with higher intraoperative target artery occlusion, conduit use, and longer length of stay. However, 30-day and long-term outcomes were similar, suggesting females can undergo complex EVAR with high technical success and comparable perioperative outcomes to males. Females appeared to have protection from long-term renal function decline, which will be important for future study.

Urgent Candy-Plug technique for distal false lumen occlusion in chronic aortic dissection

ObjectiveThis study aimed to assess the impact of urgency on early and midterm outcomes of the Candy-Plug (CP) technique for distal false lumen (FL) occlusion in thoracic endovascular aortic repair for aortic dissection. MethodsThe CP registry was reviewed, and patients were categorized into elective and urgent/emergent groups for analysis. End points included technical success, clinical success, early (30-day) computed tomography angiography findings, early (30-day) mortality, adverse events, and aortic remodeling in patients with available computed tomography angiography follow-up and reintervention. ResultsA total of 155 patients received a custom-made CP, of whom 32 patients (44% male, mean age 61 ± 9 years) were treated urgently and 123 patients (63% male, mean age 62 ± 11 years) electively. The primary CP rate was higher in the urgent group (28/32, 88%, in the urgent group vs 96/123, 78%, in the elective group, P = .051). The mean contrast volume was higher in the urgent group (157 ± 56 mL in the urgent group vs 130 ± 71 mL in the elective group, P = .017). Technical success was achieved in all patients in both groups. Clinical success was achieved in 25 of 32 (78%) patients in the urgent group vs 113 and 123 (92%) in the elective group (P = .159). The early mortality rate was 13% (4 of 32 patients) in the urgent group vs 1% (1 of 123 patients) in the elective group (P = .120). There was no statistically significant difference regarding the early adverse events between the urgent and elective CP groups. Early aortic-related reinterventions were required in 6 of 32 (19%) patients in the urgent group vs 6 of 123 (5%) in the elective group (P = .094). Thoracic aortic aneurysm sac regression was lower in the urgent group (5/28, 18%, in the urgent group vs 63/114, 55%, in the elective group, P = .001). Stable thoracic aortic aneurysm sac was higher in the urgent group (22/28, 79%, in the urgent group vs 47/114, 41%, in the elective group, P = .000). An increase in thoracic aortic aneurysm sac occurred in 1 of 28 (4%) patients in the urgent group vs 4 of 114 (4%) patients in the elective group (P = .096). ConclusionsThe urgent use of the CP technique for distal FL occlusion in aortic dissection was feasible and effective. The decrease in aortic FL sac diameter may be affected by the urgent use of CP due to limited sizing availability. However, it achieved a high rate of aortic remodeling.

Endovascular Treatment of Abdominal Aortic Aneurysm: Impact of Diabetes on Endoleaks and Reintervention.

Background: Diabetes has a protective effect on abdominal aortic aneurysms (AAAs); however, there are contrasting reports on the impact of diabetes on endovascular aortic repair (EVAR) outcomes, endoleaks (ELs) being the major negative outcome. The present study characterizes ELs and their outcomes in AAA patients, diabetic or not. Methods: This single-center, retrospective, comparative study was carried out on 324 AAA patients who underwent elective EVARs between 2007 and 2016 at the University Hospital of Liège (Belgium). The primary endpoint was the incidence and effect of ELs on the evolution of the aneurysmal sac; the secondary endpoints were surgical reintervention and mortality rate. Diabetic and non-diabetic patients were compared with respect to various risk factors by logistic regression, while a Cox regression was used to analyze survival. Results: In AAA patients meeting the inclusion criteria (n = 248), 23% were diabetic. EL incidence was comparable (p = 0.74) in diabetic (38.7%) vs. non-diabetic (43.9%) patients. EL risk factors were age (HR = 1.04, p = 0.014) and fibrate intake (HR = 3.12, p = 0.043). A significant association was observed between ELs and aneurysm sac enlargement (p < 0.001), regardless of group (p = 0.46). Aneurysm sac regression per month for non-diabetic patients was -0.24 ± 0.013, while for diabetics it was -0.18 ± 0.027 (p = 0.059). Dyslipidemia (HR = 3.01, p = 0.0060) and sulfonylureas (HR = 8.43, p = 0.043) were associated with shorter EL duration, while diabetes (HR = 0.080, p = 0.038) and beta blockers (HR = 0.46, p = 0.036) were associated with longer EL duration. The likelihood of reoperation decreased with more recent surgery (OR = 0.90, p = 0.040), regardless of diabetic status. All-cause mortality was higher for the non-diabetic group (45.5% vs. 26.3%, p = 0.0096). Conclusions: Endoleak occurrence is a known risk factor for sac expansion. In diabetic patients, endoleaks lasted longer, and regression of the aneurysm sac tended to be slower. The number and type of reintervention was not related to the diabetic status of AAA patients, but overall survival was higher in patients with diabetes.

The Effect of One Year Aneurysm Sac Dynamics on Five Year Mortality and Continued Aneurysm Sac Evolution

One year aneurysm sac dynamics after endovascular abdominal aortic aneurysm repair (EVAR) were independently associated with a greater all cause mortality risk in prior registry studies but were limited in completeness and granularity. This retrospective analysis aimed to study the impact of sac dynamics on survival within the Endurant Stent Graft Global Registry (ENGAGE) with five year follow up. A total of 1 263 subjects were enrolled in the ENGAGE Registry between March 2009 and April 2011. One year aneurysm sac changes were calculated between the one month post-operative imaging scans and the scan closest to the time of one year follow up. Sac regression was defined as a sac decrease of ≥ 5 mm and sac expansion as aneurysm sac growth ≥ 5 mm. The primary outcome was the five year all cause mortality rate. Kaplan-Meier estimates for freedom from all cause death were calculated. Multivariable Cox regression was used to determine the association between sac dynamics and all cause death. At one year, 441 of the 949 study participants with appropriate imaging (46%) had abdominal aortic aneurysm sac regression, 462 (49%) remained stable, and 46 (4.8%) had sac expansion. For patients with sac regression, the five year all cause mortality rate was 20%, compared with 28% for stable sac (p= .007) and 37% for the sac expansion (p= .010) cohorts. After adjustment, the sac expansion and stable sac cohorts were associated with a greater all cause mortality rate (expansion: hazard ratio [HR] 1.8; 95% CI 1.1 - 3.2; p= .032; stable: HR 1.4; 95% CI 1.1 - 1.9; p= .019). In the ENGAGE Global Registry, the one year rate of sac regression was 46%, and one year sac regression was observed to be associated with greater five year survival, corroborating prior findings using data from vascular registries. Sac regression could become the new standard for success after EVAR.

Five-Year Results for Abdominal Aortic Aneurysm Repair with the GORE® EXCLUDER® Device: Insights from the Gore Global Registry for Endovascular Aortic Treatment (GREAT)

ObjectivesThe early postoperative benefits of EVAR have been well established but questions remain regarding its durability at mid and long-term timepoints. Long-term results in real-world use of EVAR outside of randomized trial data are limited. This study utilized the GREAT Registry to explore the 5-year outcomes with the GORE® EXCLUDER® device in real-world clinical circumstances. MethodsAll patients within the GREAT registry that underwent an infrarenal AAA repair with the GORE® EXCLUDER® device were included in this study. Baseline characteristics and demographic information of the cohort were collected. Endpoints included mortality (all-cause and aneurysm related), serious endoleaks, aneurysm sac diameter, endograft integrity (fracture, compression, migration), post-EVAR aortic rupture, device-related reintervention, conversion to open repair, graft explantation, and major adverse cardiovascular events (MACE). ResultsA total of 3216 patients were included in this analysis. The cohort reflected a significantly comorbid population with 46% of patients reaching a Charlson comorbidity index score of ≥ 5. Follow-up at 5 years was 60% of eligible participants. The freedom from aortic-related mortality was at 98.8% and overall survival was 71.2%. Post-operative MACE occurred in 49 (1.5%) patients. Device-related intervention through 5 years was 7.2% and the overall serious endoleak rate was 6.8%. Less than 1% of patients required an open conversion/revision and aortic rupture following device placement occurred in 15 (0.5%) patients. Aneurysm sac regression was achieved in 58.1% of patients at 5 years, and stability/absence of growth was observed in 83.6% at 5 years. ConclusionsThis study supports the durability of the GORE® EXCLUDER® device though 5 years with negligible incidence of graft integrity compromise and low aortic/device-related reintervention rates. Furthermore, the efficacy of the device is highlighted with low aortic-related mortality and high sac regression/stability diameter though 5 years.

Early Clinical Results From the Japanese Prospective Multicenter Study to Evaluate Zenith Alpha Abdominal Stent Graft for Abdominal Aortic Aneurysm (JUSTICE) Registry Demonstrate Acceptable Limb Patency at 12 Months.

Recent reports of the Zenith Alpha abdominal endovascular graft (Zenith Alpha AAA, Cook, Inc., Bloomington, Indiana) have demonstrated an unexpectedly high incidence of limb graft occlusion (LGO). The purpose of this study was to prospectively evaluate the performance of the Zenith AAA in Japan, with a specific focus on LGO. All endovascular aneurysm repairs (EVARs) for abdominal aortic aneurysms performed using the Zenith Alpha AAA from July 2020 to October 2021 in 23 Japanese hospitals were prospectively evaluated. All computed tomographic images were analyzed in the core laboratory. Late complications were defined as any aneurysm-related events occurring >30 days after EVAR, including aneurysm sac enlargement of >5 mm and any reinterventions performed. Endoleaks without sac enlargement or reintervention were excluded as late complications. During the study period, 147 EVARs were performed using the Zenith Alpha AAA. The mean patient age was 76.5±7.7 years, 84.4% of patients were male, and the mean aneurysm diameter was 52.4±9.2 mm. Instruction-for-use violations were observed in 76 patients (51.7%), primarily associated with a severely angulated proximal neck (>60°). There were six intraoperative complications and 62 additional intraoperative treatments reported, most of which involved preemptive coil embolization of the inferior mesenteric artery (37 cases). Technical success, defined as the absence of type 1 or 3 endoleaks on final angiography, was achieved in 99.3% of patients. At 12 months, there was only one case of type 1/3 endoleak (0.8%) and one aneurysm sac enlargement exceeding 5 mm (0.8%); however, a high incidence of type 2 endoleaks was observed in 35.2% of patients, and aneurysm sac regression exceeding 5 mm was achieved in 30.1% of patients. Nine late complications were observed, and the rate of freedom from late complications at 12 months was 93.5%, encompassing four LGOs and one limb graft stenosis (3.4%). In contrast to recent reports, our Japanese multicenter prospective study demonstrated satisfactory early clinical results, including an acceptable LGO rate, for the low-profile Zenith Alpha AAA. Long-term follow-ups will be performed to confirm the persistence of these outcomes. This study prospectively evaluated the performance of 147 Zenith Alpha AAAs used for endovascular aneurysm repair with core-lab adjudication focusing especially on limb graft occlusion (LGO). At 12 months, aneurysm sac regression exceeding 5 mm was achieved in 30.1% of patients, and there was only one type 1/3 endoleak, one aneurysm sac enlargement (>5 mm), and nine late complications including five LGOs (3.4%), resulting in rate of freedom from late complications at 93.5%. Satisfactory early clinical results, including an acceptable rate of LGO can be achieved, particularly with cautious usage of the Zenith Alpha Spiral-Z Endovascular Leg." 5mm), and nine late complications including five LGOs (3.4%), resulting in rate of freedom from late complications at 93.5%. Satisfactory early clinical results, including an acceptable rate of LGO can be achieved, particularly with cautious usage of the Zenith Alpha Spiral-Z Endovascular Leg.

Use of EndoAnchors during index endovascular aortic aneurysm repair in patients with hostile proximal aortic neck anatomy.

Standard endovascular aortic aneurysm repair (EVAR) is sometimes the only treatment option for patients with hostile aortic neck anatomy, but it carries an increased risk of both early and late procedure-related complications. The aim of this study was to report on single-center experience with the Heli-FX EndoAnchors (Medtronic, Santa Rosa, CA) as an adjunctive procedure to endovascular aneurysm repair (EVAR) for prevention and perioperative treatment of proximal neck complications in patients with hostile neck anatomy. MATERIALS AND METHODS:Asingle-centre, retrospective study evaluating 24 consecutive patients treated with EndoAnchors during the index EVAR procedure between November 2018 and August 2021. EndoAnchor implantation was indicated for cases with hostile proximal aortic neck anatomy characterised by the presence of at least one of the following parameters: length of 28 mm, angle of >60°, circumferential thrombus/calcification involving ≥50%, and reverse taper. Median follow-up period was 22.5 months (IQR 2-31.5 months) with no aneurysm-related death, rupture, or conversion to open surgical repair during the follow-up. The procedural success rate was 100%, with no type Ia endoleak at the completion angiography. Amean of 7 EndoAnchors was used per patient (range 4-12). There were no EndoAnchor fractures and dislocations or stent graft fabric damage due to anchor implants.Twenty-three patients (95.8%) remained free of type Ia endoleak and migration on follow-up imaging. Aneurysm sac regression was observed in 13 patients (54.1%), while in 8 patients (33.3%) the sac remained stable. Sac enlargement was present in 1 patient (4.2%) due to late type Ia endoleak. Twopatients were lost to the follow-up immediately after the procedure.Between two groups of patients (sac regression versus failure to regress), the larger initial diameter of the proximal neck was the only significant independent factor associated with a lower possibility of sac regression (p= 0,021). The use of EndoAnchors during the index EVAR procedure in cases with challenging aortic neck anatomy with or without perioperative type Ia endoleak was associated with good midterm results and led to sac regression in most of the patients (Tab. 4, Fig. 3, Ref. 31).

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.

Use of physician-modified inverted limb in conjunction with Zenith fenestrated stent graft to rescue failed previous endovascular and open repair

ObjectiveTo evaluate outcomes and performance of inverted limbs (ILs) when used in conjunction with Zenith fenestrated stent grafts (Zfens) to treat patients with short distance between the lowest renal artery (RA) and aortic or graft bifurcation (A/GB). MethodsThis study was a multicenter, retrospective review of prospectively maintained database of patients with complex aortic aneurysms, failed endovascular aneurysm repair (EVAR), or open surgical repair (OSR) with short distance between LRA and A/GB treated using a combination of Zfen and an IL between 2013 and 2023. Endpoints included technical success, aneurysm sac regression, long-term device integrity, and target vessel patency. We defined technical success as implantation of the device with no endoleak, conversion to an aorto-uni-iliac or OSR. ResultsDuring this time, 52 patients underwent endovascular rescue of failed repair. Twenty (38.5%) of them required relining of the failed repairs using IL due to lowest RA to A/GB length restrictions. Two patients had undergone rescue with a fenestrated cuff alone but developed type III endoleaks. One patient with no previous implant had a short distance between the lowest RA and aortic bifurcation to accommodate the bifurcated distal device, and two patients had failed OSR or anastomotic pseudoaneurysms. The majority (94%) were men with a mean age of 76.8 ± 6.1 years. The mean aortic neck diameter and aneurysm size were 32 ± 4 cm and 7.2 ± 1.3 cm, respectively. The median time laps between initial repair and failure was 36 months (interquartile range [IQR], 24-54 months). Sixteen patients (80%) were classified as American Society of Anesthesiologists class III, whereas four were class IV. Seventy-eight vessels were targeted and successfully incorporated. Technical success was 100%, and median estimated blood loss was 100 mL (IQR, 100-200 mL). Mean fluoroscopy time and dose were 61 ± 18 minutes and 2754 ± 1062 mGy, respectively. Average hospital length of stay was 2.75 ± 2.15 days. Postoperative complication occurred in one patient who required lower extremity fasciotomy for compartment syndrome. At a median follow-up of 50 months (IQR, 18-58 months), there were no device migration, components separation, aneurysmal related mortality, and type I or type III endoleak. Aneurysm sac regression (95%) or stabilization (5%) was observed in all patients, including in four patients (25%) with type II endoleak. ConclusionsThe use of IL in conjunction with Zfen to treat patients with short distance between the lowest RA and A/GB is safe, effective, and has excellent long-term results. The technique expands the indication of Zfen, especially in patients with failed previous EVAR.

Five Year Post-Endovascular Aneurysm Repair Aneurysm Sac Evolution in the GREAT Registry: an Insight in Diabetics Using Propensity Matched Controls

To assess differences in the five year abdominal aortic aneurysm (AAA) sac regression rate after endovascular aneurysm repair (EVAR) in patients with and without diabetes mellitus (DM). An international prospective registry (Europe, USA, Brazil, Australia, and New Zealand) of patients treated with the GORE EXCLUDER endograft. All scheduled EVARs for infrarenal AAA between 2014 and 2016 with complete five year imaging follow up were included. Emergency procedures, ancillary proximal procedures, and inflammatory and infectious aetiologies were excluded. Descriptive and inferential statistics, and Cox proportional hazards survival models were used. A control group of patients without DM with similar age and comorbidities was selected using propensity scores, matched in a 1:2 scheme. A total of 2 888 patients (86.1% male; mean age 73.5 ± 8 years) was included, of whom 545 (18.9%) had DM. Patients with DM had higher rates of hypertension (89.2% vs. 78.4%), dyslipidaemia (76.0% vs. 60.7%), coronary artery disease (52.3% vs. 37.9%), and chronic renal impairment (20.9% vs. 14.0%) (all p < .001). The mean pre-procedural AAA diameter was 58.1 ± 10 mm. Five years post-EVAR, the type 1A endoleak rate was 1.1% (0.6% DM vs. 1.2% non-DM), the endograft related re-intervention rate was 7.3% (6.2% vs. 7.6%), the major adverse cardiovascular event (MACE) rate was 1.4% (1.1% vs. 1.5%), and aortic related mortality rate was 1.0% (0.6% vs. 1.2%), without statistically significant differences between groups. The overall five year mortality rate was higher in diabetics (36.3% vs. 30.5%; hazard ratio [HR] 1.30, 95% confidence interval [CI] 1.07 - 1.58; p= .001). No statistically significant differences were found in sac regression rate (≥ 5 mm) between diabetics and non-diabetics 70.0% vs. 73.1%; HR 0.88, 95% CI 0.75-1.04; p = .131. These differences remained statistically non-significant after excluding patients performed out of instructions for use (p= .61) and patients with types 1, 2 or 3 endoleaks (p= .39). The paradoxical relationship between DM and AAA does not appear to result in differences in post-EVAR sac regression rates. However, even when controlling for other comorbidities, patients with DM undergoing EVAR may have a higher five year mortality rate.

Association of Baseline Chronic Kidney Disease Stage With Short- and Long-Term Outcomes After Fenestrated Endovascular Aneurysm Repair

Fenestrated endovascular aneurysm repair (FEVAR) is a well-established treatment approach for juxtarenal and short-neck infrarenal aortic aneurysms. Recommendations and clinical outcomes are lacking for offering FEVAR in patients with chronic kidney disease (CKD). We aimed to compare short- and long-term outcomes for patients with none-to-mild versus moderate-to-severe CKD undergoing FEVAR. We retrospectively reviewed consecutive patients undergoing standard FEVAR with Cook devices at a single institution. The cohort was stratified by preoperative CKD stage none-to-mild or moderate-to-severe (CKD 1-2 and CKD 3-5, respectively). The primary outcome was postoperative acute kidney injury (AKI). Secondary outcomes included 30-day perioperative complications, 1- and 5-year rates of overall survival, dialysis, renal target artery patency, endoleak, and reintervention assessed by the Kaplan-Meier method. Aneurysm sac regression, number of surveillance computed tomography (CT) scans, and CKD stage progression were assessed at latest follow-up. Multivariate Cox proportional hazards modeling was used to evaluate the association of CKD stage 3 and stage 4-5 with all-cause mortality, controlling for differences in baseline characteristics. From 2012- to 2022, 184 patients (of which 82% were male) underwent FEVAR with the Cook ZFEN device (mean follow-up 34.3months). Group CKD 3-5 comprised 77 patients (42%), was older (75.2 vs. 73.0years, P=0.04), had increased preoperative creatinine (1.6 vs. 0.9mg/dL, P<0.01), and demonstrated increased renal artery ostial calcification (37.7% vs. 21.5%, P=0.02) compared with Group CKD 1-2. Perioperatively, CKD 3-5 sustained higher estimated blood loss (342 vs. 228ml, P=0.01), longer operative times (186 vs. 162min, P=0.04), and longer length of stay (3 vs. 2days, P<0.01). Kaplan-Meier 1- and 5-year survival estimates were lower for CKD 3-5 (82.3% vs. 95.1%, P<0.01 and 55.4% vs. 70.8%, P=0.02). Fewer CKD 3-5 patients remained free from chronic dialysis at 1year (94.4% vs. 100%, P=0.015) and 5years (84.7% vs. 100%, P<0.01). There were no significant differences in postoperative AKI rate (CKD 1-2 6.5% vs. CKD 3-5 14.3%, P=0.13), long-term renal artery patency, reinterventions, type I or III endoleak, mean sac regression, or total follow-up CT scansbetween groups. CKD stage progression occurred in 47 patients (31%) at latest follow-up but did not differ between stratified groups (P=0.17). On multivariable modeling, age (hazardratio 1.05, 95% confidence interval 1.01-1.09, P=0.02) and CKD stage 4-5 (hazard ratio 6.39, 95% confidence interval 2.26-18.05, P<0.01) were independently associated with mortality. Preoperative CKD status did not negatively impact the durability or technical success related to aneurysm outcomes after FEVAR. Worsening CKD stage was associated with lower 1- and 5-year overall survival and freedom from dialysis after FEVAR with no statistically significant differences in 30-day or long-term technical aneurysm outcomes.

Five-Year Outcomes of Endovascular Aortic Repair With the TREO Abdominal Endograft.

Newer generation abdominal endografts, including Treo (Terumo Aortic, Sunrise, Florida), have shown optimal safety and effectiveness in treating abdominal aortic aneurysms (AAAs), even with hostile anatomy over the short- and mid-term. The durability of such results, however, is still a controversial issue, due to the paucity of long-term data. Our aim is to show the long-term outcomes of endovascular aortic repair of both standard and hostile AAAs with the Treo endograft on a cohort of patients treated between 2016 and 2017. We analyzed the postoperative follow-up of 37 consecutive patients who have undergone endovascular aortic repair (EVAR) with the Treo Endograft between 2016 and 2017, whose baseline clinical conditions, operative data, and short-term outcomes had been published in 2018. All patients were followed up by computed tomography angiography (CTA) at 6 and 12 months and 5 years postoperatively. Primary endpoints were aortic-related mortality, type I-III endoleak (EL), and reintervention rate. Secondary endpoints were the rates of type II ELs and aneurysm sac regression. Of 37 patients, 27 had at least one criterion of anatomic hostility and 11 were performed outside the device-specific instructions for use (IFU). In the perioperative period, we observed 100% technical success, with no perioperative mortality. Over a mean follow-up of 5.5 years (66 months), 3 patients (8.1%) were lost to follow-up and 3 (8.1%) died of non-aortic causes (overall survival: 91.9%). One type IA EL of an AAA with a hostile neck (but within the IFU) and a type III EL of an AAA with standard anatomy were observed and treated by endovascular relining (overall reintervention rate: 5.5%). Four type II ELs were associated with aneurysm sac stability over time and are still under surveillance. Mean aneurysm shrinkage was 11.25±8.30 mm. The optimal results of the Treo Endograft in terms of complication and reintervention rates reported over the mid-term by the current literature (ITA-ENDOBOOT registry) are maintained on the long term, both in case of hostile and friendly aortic anatomy, with a satisfactory shrinkage rate of the aneurysm sac. The innovative characteristics of Treo and its short-term results are well-known and reported. The present case series contributes to the scientific validation of a new-generation abdominal aortic endograft over the long-term, focusing especially on its performance in treating AAAs with hostile anatomy. Its 5-years outcomes confirm the optimal results already reported over the short- and mid-term.

High incidence of type 2 endoleak and low associated adverse events in the Vascular Quality Initiative linked to Medicare claims

IntroductionType 2 endoleak (T2EL) is the most common adverse finding on postoperative surveillance after endovascular aortic aneurysm repair (EVAR). A low rate of aneurysm-related mortality with T2EL has been established. However, the optimal management strategy and the efficacy of reintervention remain controversial. This study used data from the Vascular Quality Initiative linked to Medicare claims (VQI-Medicare) to evaluate T2LE in a real-world cohort. MethodsThis retrospective review of EVAR procedures in VQI-Medicare included patients undergoing their first EVAR procedure between 2015 and 2017. Patients with an endoleak other than T2EL on completion angiogram and those without VQI imaging follow-up were excluded. Patients without Medicare part A or part B enrollment at the time of the procedure or without 1-year complete Medicare follow-up data were also excluded. The exposure variable was T2EL, defined as any branch vessel flow detected within the first postoperative year. Outcomes of interest were mortality, reintervention, T2EL-related reintervention, post-EVAR imaging, and T2EL behavior including spontaneous resolution, aneurysm sac regression, and resolution after reintervention. The association of prophylactic branch vessel embolization (PBE) with T2EL resolution and aneurysm sac regression was also evaluated. ResultsIn a final cohort of 5534 patients, 1372 (24.7%) had an identified T2EL and 4162 (75.2%) did not. The median age of patients with and without T2EL was 77 and 75 years, respectively. There were no differences in mortality, imaging, reintervention, or T2EL-related reintervention at 3 years after the procedure for patients with T2EL. The aneurysm sac diameter decreased by 4 mm (range: 9-0 mm decrease) in the total cohort. Patients with inferior mesenteric artery-based T2EL had the smallest decrease in aneurysm diameter (median 1 mm decrease compared with 1.5 mm for accessory renal artery-based T2EL, 2 mm for multiple feeding vessel-based T2EL, and 4 mm for lumbar artery-based T2EL; P < .001). Spontaneous resolution occurred in 73.7% of patients (n = 809). T2ELs with evidence of multiple feeding vessels were associated with the lowest rate of spontaneous resolution (n = 51, 54.9%), compared with those with a single identified feeding vessel of inferior mesenteric artery (n = 99, 60.0%), lumbar artery (n = 655, 77.7%), or accessory renal artery (n = 31, 79.5%) (P < .001). PBE was performed in 84 patients. Patients who underwent PBE and were without detectable T2EL after EVAR had the greatest rate of sac regression at follow-up (7 mm decrease) compared with baseline. ConclusionsT2EL after EVAR is associated with high rates of spontaneous resolution, low rates of aneurysm sac growth, and no evidence of increased early mortality or reintervention. PBE in conjunction with EVAR may be indicated in some circumstances.

Feasibility of aortic aneurysm sac embolization using a novel shape memory polymer embolic device

BackgroundWe investigated the feasibility of aneurysm sac embolization using a novel self-expanding porous shape memory polymer (SMP) device during endovascular aortic abdominal or thoracic aneurysm repair (EVAR).MethodsRetrospective analysis of consecutive patients treated at 2 centers in Germany. Patients were treated from January 2019 to July 2021 with follow-up at 7 days and 3, 6, and 12 months. Aneurysm sacs were implanted with SMP devices immediately following endograft placement during the same procedure. Primary endpoint was technically successful SMP-device deployment into the aneurysm sac outside the endograft. Secondary endpoints were changes in aneurysm volume and associated complications (e.g., endoleaks).ResultsWe included 18 patients (16 males), aged 72 ± 9 years, achieving 100% technical success. Mean preprocedure aortic aneurysm sac volume was 195 ± 117 mL with a perfused aneurysm volume of 97 ± 60 mL. A mean of 24 ± 12 SMP devices per patient were used (range 5–45, corresponding to 6.25–56.25 mL expanded embolic material volume). All evaluable patients exhibited sac regression except 2 patients yet to reach 3-month follow-up. At mean 11 ± 7 months (range 3–24), change in aneurysm volume from baseline was -30 ± 21 mL (p < 0.001). In 8 patients, aneurysm regression was observed despite type 2 endoleaks in 6 and type 1A endoleaks in 2, none of them requiring further intervention to date. No morbidity or mortality related to this treatment occurred.ConclusionsSMP devices for aortic aneurysm sac embolization during endovascular repair appear feasible and safe in this small case series. Prospective studies are needed.Key points• Shape memory polymer is a novel, self-expanding, porous, and radiolucent embolic device material.• Aortic aneurysm sacs were treated with polymer devices immediately following endograft placement.• Aortic aneurysm sac regression was observed in all patients with over 3-month follow-up.• Aortic aneurysm sac regression was observed even in the presence of endoleaks.

Association Between Obesity and Outcomes Following Endovascular Aneurysm Repair

Obesity is prevalent in patients with abdominal aortic aneurysms (AAA). There is an association between increasing body mass index (BMI) and increased overall cardiovascular mortality and morbidity. This study aims to assess the difference in mortality and complication rates between normal weight (NW), overweight (OW), and obese patients undergoing endovascular aneurysm repair (EVAR) for infrarenal AAA. This is a retrospective analysis of consecutive patients undergoing EVAR for AAA between January 1998 and December 2019. Weight classes were defined as: BMI<18.5kg/m2, underweight; BMI 18.5-24.9kg/m2, NW; BMI 25.0-29.9kg/m2, OW; BMI 30.0-39.9kg/m2, obese; BMI>39.9kg/m2 morbidly obese. Primary outcomes were long-term all-cause mortality and freedom from reintervention. Secondary outcome was aneurysm sac regression (defined as a reduction in sac diameter of 5mm or more). Kaplan-Meier survival estimates and mixed model analysis of variance were used. The study included 515 patients (83% males, mean age 77±8years) with a mean follow-up of 3.8±2.8years. In terms of weight class, 2.1% (n=11) were underweight, 32.4% (167) were NW, 41.6% (n=214) were OW, 21.2% (n=109) were obese, and 2.7% (n=14) were morbidly obese. Obese patients were younger (mean difference -5.0years) but had a higher prevalence of diabetes mellitus (33.3% vs. 10.6% for NW) and dyslipidemia (82.4% vs. 60.9% for NW). Obese patients had similar freedom from all-cause mortality (88%) compared to OW (78%) and NW (81%) patients. The same findings were evident for freedom from reintervention where obese (79%) was similar to OW (76%) and NW (79%). At a mean follow-up of 5.1±0.4years, sac regression was observed similarly across weight classes at 49.6%, 50.6%, and 51.8% for NW, OW, and obese, respectively (P=0.501). There was a significant difference in mean AAA diameter pre- and post-EVAR [F(2,318)=24.37, P<0.001] across weight classes. NW [mean reduction 4.8mm (2.0-7.6mm, P<0.001)], OW [mean reduction 3.9mm (1.5-6.3mm, P<0.001)], and obese [mean reduction 5.7mm (2.3-9.1mm, P<0.001)] achieved similar reductions. Obesity was not associated with increased mortality or reintervention in patients undergoing EVAR. Obese patients achieved similar rates of sac regression on imaging follow-up.

Changes in intraoperative aortic strain as detected by ultrasound elastography in patients following abdominal endovascular aneurysm repair.

Predicting success after endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs) relies on measurements of aneurysm sac regression. However, in the absence of regression, morphometric analysis alone is insufficient to reliably predict the successful remodeling of AAAs after EVAR. Biomechanical parameters, such as pressure-normalized principal strain, might provide useful information in the post-EVAR AAA assessment. Our objective was to assess the feasibility of our novel ultrasound elastography (USE) technique to detect changes in the aortic wall principal strain in patients who had undergone EVAR and determine the temporal nature of the biomechanical changes in the aorta. USE images were obtained from patients undergoing elective EVAR intraoperatively, immediately before and after endograft implantation, and at their 30-day follow-up. The maximal mean principal strain ( ) for each scan was assessed using our novel technique, which uses a finite element mesh to track the frame-to-frame displacements of the aortic wall over one cardiac cycle. The in the user-defined aortic wall was then divided by the pulse pressure at the time of the scan to produce a pressure-normalized strain measurement ( /PP), a surrogate for tissue stiffness. Paired t tests were used to compare the pre- and postoperative /PP and the postoperative and 30-day /PP. Patient 30-day sac regression and endoleak data were collected by a review of 30-day follow-up computed tomography scans. USE analysis of the data from 12 patients demonstrated a significant reduction in aortic wall /PP (average, 0.191%± 0.09%/kPa vs 0.087%± 0.04%/kPa; P= .002) immediately after graft implantation, with a nonsignificant change in the /PP (0.091%± 0.04%/kPa vs 0.102%± 0.05%/kPa; P= .47) from postoperatively to 30-day follow-up. This represents an average 46.5% reduction after stent placement, with a nonsignificant 18.1% increase at 30-day follow-up. All the patients showed sac stability, except for two patients who had demonstrated 7.3-mm and 6.8-mm sac regressions. Our analysis has demonstrated that the presented USE technique is a feasible method for detecting significant reductions in aortic /PP intraoperatively after EVAR. We found that patients undergoing EVAR will experience large reductions in the /PP intraoperatively after graft implantation, with stabilization found at their 30-day follow-up. These preliminary data have shown that an intraoperative /PP reduction could be a promising correlate of post-EVAR aneurysm remodeling. Our results have also suggested that endograft design likely plays a large role in determining the aneurysm biomechanical changes immediately after implantation.

Volumetric analysis of effectiveness of embolization for preventing type II endoleaks following endovascular aortic aneurysm repair

ObjectiveThe presence of endoleak was associated with the failure of endovascular aortic aneurysm repair (EVAR) treatment. The key to eliminating type II endoleak has shifted from reintervention to prevention. This study aimed to evaluate the effectiveness and safety of applying fibrin sealant to prevent type II endoleak in conjunction with EVAR. MethodsAll patients with abdominal aortic aneurysm who underwent EVAR from June 2019 to July 2021 were reviewed. Patients were grouped as Group A: standard EVAR with preemptive embolization and Group B: standard EVAR alone. The primary endpoint was the incidence of type II endoleak. The secondary endpoints were aneurysm sac regression, the inferior mesenteric artery patency, the numbers of patent lumbar arteries, and all-cause mortality. ResultsA total of 104 patients were included in Group A, and 116 were included in Group B. Technical success rate was 100%. The overall incidence of type II endoleak in Group A was significantly lower than that in Group B (4.8% vs 19.0%). The mean time of freedom from type II endoleak was 22.71 months for Group A (95% confidence interval, 21.59-23.83 months) and 19.89 months for Group B (95% confidence interval, 18.08-21.70 months). The Kaplan-Meier estimate of freedom from type II endoleak showed a significantly longer duration of freedom from type II endoleak in Group A (81.0% vs 95.2%). Group A showed a continuous sac regression tendency. In Group B, the sac volume decreased within 12 months but increased by 3.07 cm3 at 24 months. No complications were noted in both groups. ConclusionsNonselective preemptive embolization with porcine fibrin sealant during EVAR was safe and effective in preventing type II endoleak in the short and mid-term. Preemptive embolization can lead to a significantly higher sac regression rate. Larger patient populations and longer follow-ups with randomized control designed trials are expected to verify the long-term effectiveness and safety of preemptive embolization in preventing type II endoleak.

The Effect of EndoAnchors on Aneurysm Sac Regression for Patients Treated With Infrarenal Endovascular Repair With Hostile Neck Anatomies: A Propensity Scored Analysis

Purpose: To analyze sac evolution patterns in matched patients with hostile neck anatomy (HNA) treated with standard endovascular aneurysm repair (sEVAR) and endosutured aneurysm repair (ESAR). Methods: Observational retrospective study using prospectively collected data between June 2010 and December 2019. ESAR group data were extracted from the primary arm of the PERU registry with an assigned identifier (NCT04100499) at 8 centers and those from the sEVAR came from 4 centers. Suitability for inclusion required: no proximal endograft adjuncts (besides EndoAnchor use), ≤15 mm neck length and minimum of 12-months follow-up imaging. Bubble-shaped neck (noncylindrical short neck with discontinuous seal) aspect was analyzed. Both groups were analyzed using propensity score matching (PSM) for aortic neck length, width, angulation, and device fixation type. Main outcome assessed was sac evolution patterns (sac expansion and regression were defined as >5mm increase or decrease, of the maximum sac diameter respectively; all AAAs within this ±5 mm range in diameter change were considered stable) and secondary outcomes were type-Ia endoleaks; other endoleaks and mortality. A power analysis calculation >80% was confirmed for sac regression evaluation. Results: After exclusions, PSM resulted in 96 ESAR and 96 sEVAR patients. Mean imaging follow-up (months) was 44.4±21.3 versus 43.0±19.6 (p=0.643), respectively. The overall number of patients achieving sac regression was higher in the ESAR group (n=57, 59.4% vs n=31, 32.3%; p<0.001) and the cumulative sac regression achieved at 5 years was 65% versus 38% (p=0.003) in favor of the ESAR group. There were no statistically significant differences in type-Ia endoleak and/or other endoleaks. Univariate analysis for sac regression patients in the sEVAR and ESAR group individually showed the bubble-shape neck as a predictor of sac regression failure. There were no statistical differences in overall and aneurysm-related mortality. Conclusion: Endosutured aneurysm repair provided improved rates of sac regression for patients with AAA and HNA when compared with sEVAR at midterm and up to 5 years, despite similar rates of type-Ia endoleaks, and the need to consider some important limitations. The presence of bubble-shaped neck was a predictor of sac regression failure for both groups equally. Clinical Impact The use of EndoAnchors aids and improves EVAR treatment in hostile neck anatomies by an increased rate of sac regression when compared to EVAR treatment alone in up to 5 year analysis. Moreover, a trend to reduced number of type Ia endoleaks is also achieved, although not significant in the present study. This data, adds to current and growing evidence on the usefulness of EndoAnchors for AAA endovascular treatment.

Endovascular infrarenal aortic aneurysm repair: Perhaps we've gone about it all wrong

Endovascular infrarenal aortic aneurysm repair: Perhaps we've gone about it all wrong