Early and Late Aortic-Related Mortality and Rupture After Fenestrated-Branched Endovascular Aortic Repair of Thoracoabdominal Aortic Aneurysms: A Prospective Multicenter Cohort Study.

BACKGROUND: Fenestrated-branched endovascular aortic repair (FB-EVAR) has been used as a minimally invasive alternative to open surgical repair to treat patients with thoracoabdominal aortic aneurysms (TAAAs). The aim of this study was to evaluate aortic-related mortality (ARM) and aortic aneurysm rupture after FB-EVAR of TAAAs. METHODS: Patients enrolled in 8 prospective, nonrandomized, physician-sponsored investigational device exemption studies between 2005 and 2020 who underwent elective FB-EVAR of asymptomatic intact TAAAs were analyzed. Primary end points were ARM, defined as any early mortality (30 days or in hospital) or late mortality from aortic rupture, dissection, organ or limb malperfusion attributable to aortic disease, complications of reinterventions, or aortic rupture. Secondary end points were early major adverse events, TAAA life-altering events (defined as death, permanent spinal cord injury, permanent dialysis, or stroke), all-cause mortality, and secondary interventions. RESULTS: A total of 1109 patients were analyzed; 589 (53.1%) had extent I-III and 520 (46.9%) had extent IV TAAAs. Median age was 73.4 years (interquartile range, 68.1-78.3 years); 368 (33.2%) were women. Early mortality was 2.7% (n=30); congestive heart failure was associated with early mortality (odds ratio, 3.30 [95% CI, 1.22-8.02]; P=0.01). Incidence of early aortic rupture was 0.4% (n=4). Incidence of early major adverse events and TAAA life-altering events was 20.4% (n=226) and 7.7% (n=85), respectively. There were 30 late ARMs; 5-year cumulative incidence was 3.8% (95% CI, 2.6%-5.4%); older age and extent I-III TAAAs were independently associated with late ARM (each P<0.05). Fourteen late aortic ruptures occurred; 5-year cumulative incidence was 2.7% (95% CI, 1.2%-4.3%); extent I-III TAAAs were associated with late aortic rupture (hazard ratio, 5.85 [95% CI, 1.31-26.2]; P=0.02). Five-year all-cause mortality was 45.7% (95% CI, 41.7%-49.4%). Five-year cumulative incidence of secondary intervention was 40.3% (95% CI, 35.8%-44.5%). CONCLUSIONS: ARM and aortic rupture are uncommon after elective FB-EVAR of asymptomatic intact TAAAs. Half of the ARMs occurred early, and most of the late deaths were not aortic related. Late all-cause mortality rate and the need for secondary interventions were 46% and 40%, respectively, 5 years after FB-EVAR. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02089607, NCT02050113, NCT02266719, NCT02323581, NCT00583817, NCT01654133, NCT00483249, NCT02043691, and NCT01874197.

Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries: The SAFE-AAA Study.

BACKGROUND: Concerns have been raised about the long-term performance of aortic stent grafts for the treatment of abdominal aortic aneurysms, in particular, unibody stent grafts (eg, Endologix AFX AAA stent grafts). Only limited data sets are available to evaluate the long-term risks related to these devices. The SAFE-AAA Study (Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries Study) was designed with the Food and Drug Administration to provide a longitudinal assessment of the safety of unibody aortic stent grafts among Medicare beneficiaries. METHODS: The SAFE-AAA Study was a prespecified, retrospective cohort study evaluating whether unibody aortic stent grafts are noninferior to non-unibody aortic stent grafts with respect to the composite primary outcome of aortic reintervention, rupture, and mortality. Procedures were evaluated from August 1, 2011, through December 31, 2017. The primary end point was evaluated through December 31, 2019. Inverse probability weighting was used to account for imbalances in observed characteristics. Sensitivity analyses were used to evaluate the effect of unmeasured confounding, including assessment of the falsification end points heart failure, stroke, and pneumonia. A prespecified subgroup included patients treated from February 22, 2016, through December 31, 2017, corresponding to the market release of the most contemporary unibody aortic stent grafts (Endologix AFX2 AAA stent graft). RESULTS: Of 87 163 patients who underwent aortic stent grafting at 2146 US hospitals, 11 903 (13.7%) received a unibody device. The average age of the total cohort was 77.0±6.7 years, 21.1% were female, 93.5% were White, 90.8% had hypertension, and 35.8% used tobacco. The primary end point occurred in 73.4% of unibody device-treated patients versus 65.0% of non-unibody device-treated patients (hazard ratio, 1.19 [95% CI, 1.15-1.22]; noninferior P value of 1.00; median follow-up, 3.4 years). Falsification end points were negligibly different between groups. In the subgroup treated with contemporary unibody aortic stent grafts, the cumulative incidence of the primary end point occurred in 37.5% of unibody device-treated patients and 32.7% of non-unibody device-treated patients (hazard ratio, 1.06 [95% CI, 0.98-1.14]). CONCLUSIONS: In the SAFE-AAA Study, unibody aortic stent grafts failed to meet noninferiority compared with non-unibody aortic stent grafts with respect to aortic reintervention, rupture, and mortality. These data support the urgency of instituting a prospective longitudinal surveillance program for monitoring safety events related to aortic stent grafts.

Clinical outcomes of MANTA closure device in percutaneous endovascular aortic aneurysm repair.

OBJECTIVE: The MANTA device is a plug-based vascular closure device (VCD) designed for large bore femoral arterial access site closure. It showed promising results in transcatheter aortic valve replacement cases. In this study, we report our results and evaluate the MANTA VCD in percutaneous endovascular aortic aneurysm repair (pEVAR). METHODS: All data of consecutive patients who underwent an elective pEVAR between October 2018 and December 2022 were retrospectively reviewed. In all patients at least one common femoral artery was intended to close with the MANTA VCD. Depending on the sheath size, the 14Fr or 18Fr MANTA VCD was used. On the preoperative computed tomography scan, the diameter of the common femoral artery (CFA) was measured and the amount of calcification based on the Peripheral Arterial Calcium Scoring System (PACSS) was scored. Primary outcome was procedural technical success. Procedural technical success was defined as placement of the MANTA closure device resulting in vascular closure with patent CFA, without requiring immediate open or endovascular surgery. The secondary outcomes were access site complications requiring reintervention and all-cause mortality at 30-day follow-up. RESULTS: In total, 152 consecutive patients underwent pEVAR with 291 common femoral artery closure procedures with the Manta VCD. Mean age was 74.1 ± 6.4 years, with a mean body mass index of 27.7 ± 4.4 kg/m2. The mean diameter of the CFA was 10.5 ± 1.9 mm. In 52.6% of the cases, there were no calcification on the preoperative computed tomography scan. The 18Fr and 14Fr Manta VCD were used 169 and 122 times, respectively. The technical success rate was 96.6%. Major vascular complications were reported in 4.5% of the cases, without any death-related events. CONCLUSIONS: This single-center retrospective cohort study analyzed the procedural technical success, major vascular complications and all-cause mortality at 30-day follow-up of the MANTA vascular closure device in 152 pEVAR patients with 291 common femoral artery closure procedures. The technical success rate was 96,6%. Major vascular complications were reported in 4.5% of the cases, without any death related events. We concluded that the MANTA device is a safe and feasible option with a high rate of technical success in patients undergoing pEVAR.

Systematic review of risk factors and outcomes of post-implantation syndrome following endovascular aortic repair.

OBJECTIVE: Post implantation syndrome (PIS) is an early systemic inflammatory response following endovascular aortic repair (EVAR). The response is variable in patients and the clinical significance of PIS upon outcomes is unknown. This study aims to evaluate the incidence, risk factors, and prognostic implication of PIS. METHODS: Systematic literature review and analysis was performed in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) and Cochrane guidelines of PubMed, Scopus, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials. Eligible English-language studies regarding PIS after infrarenal EVAR were included, after removing duplicates. RESULTS: After screening, 31 studies were included. A total of 2847 patients were reviewed, with mean age of 70.7 years, of which 2012 (90.4%) were male, with a pooled mean follow-up of 26.1 months. PIS was reported in 25.3% of cases, with mean aneurysm diameter of 56.4 cm. Polytetrafluoroethylene (PTFE) grafts were utilized in 794 patients (27.9%) with polyester in 1839 (64.6%). White blood cell count, C-reactive protein, interleukin (IL)-6, IL-8, and IL-10 levels were all significantly elevated postoperatively. Thirty-day outcomes included type I endoleak rate of 0.8%, type II endoleak rate of 1.7%, reintervention rate of 0.35%, and mortality rate of 0.25%. Subgroup pooled analysis of patients with PIS (n = 309) vs No-PIS (n = 691) revealed that polyester (n = 642), rather than PTFE (n = 234) grafts, were associated with a higher rate of PIS (94.8% vs 3.7%; P = .0001), White blood cell count was higher in the PIS group both preoperatively (7.61 vs 6.76 × 109/L; P = .04) and postoperatively (15.0 vs 9.8 × 109/L; P = .0007) and IL-6 levels were higher in the PIS group postoperatively (98.6 vs 25.2 pg/mL; P = .02). Aneurysm diameter and amount of chronic or new thrombus within the aneurysm sac was not identified as a risk factor for PIS. Pooled outcomes of patients with PIS vs No-PIS demonstrated a significantly higher rate of 30-day mortality (0.6% vs 0%; P = .03) and major adverse cardiac events (5.8% vs 0.43%; P < .0001) without any differences seen in reintervention or 30-day type I or type II endoleaks. CONCLUSIONS: This systematic review suggests that polyester grafts are strongly associated with PIS compared with PTFE. Interestingly, this report is suggestive of an association between 30-day mortality and major adverse cardiac events and PIS. Given these clinical sequelae, consideration for use of PTFE over polyester grafts to reduce the incidence of PIS may be a simple step to improve overall outcome. Further, exploration of the relationship between inflammatory mediators associated with PIS and mortality and cardiac complications may engender deeper understanding of risks, leading to eventual mitigation of harm for patients experiencing PIS.

Adoption and clinical outcomes of fenestrated endovascular aneurysm repair in a regional, multistate community hospital system.

OBJECTIVE: Complex endovascular abdominal aortic aneurysm (AAA) repair techniques have evolved over the last decade, yet patterns of physician and hospital system adoption of fenestrated endovascular aneurysm repair (FEVAR) remain poorly defined. We investigated clinical outcomes, use trends, and surgeon and hospital experience for FEVAR in a large community hospital system. METHODS: We conducted a retrospective cohort study of all FEVAR procedures within our 5-state hospital system between April 2012 and June 2021. AAA repair volumes (open, EVAR, and FEVAR) were captured at the hospital and surgeon levels using Current Procedural Terminology and International Classification of Diseases codes. Clinical and outcomes data were collected for FEVAR patients. To consider if surgeon or hospital experience influenced outcomes, sequential case number was used to divide patients into surgeon experience and hospital experience groups. Inverse probability weighted and generalized linear mixed models, adjusted for demographics and comorbidities, were built to examine risk-adjusted outcomes for surgeon and hospital experience groups. RESULTS: Of 3850 patients treated with AAA procedures of any kind between 2012 and 2021, 160 (4.2%) underwent FEVAR. FEVAR procedures were performed by 34 different surgeons at 12 hospitals, with intraoperative complications and unplanned adjunctive procedures occurring in 18.8% (n = 30) and 19.4% (n = 31) of patients, respectively. Among FEVAR patients, in-hospital mortality was 1.3% (n = 2) and postoperative morbidity was 16.9% (n = 27). Renal function decline occurred postoperatively in 5.1% of patients. Early (<30 day) postoperative endoleaks occurred in 15.3% of patients (n = 21). Target vessel patency was 95.6% on initial postoperative imaging. Surgeon and hospital experience had a small positive impact on outcomes after the first one to three cases. Significant decreases in operative time, fluoroscopy time, and estimated blood loss were observed with increased surgeon experience, relative to a surgeon's first case (P < .05). There were lower odds of intraoperative complications after a surgeon's first case (odds ratio [OR], 0.16; 95% confidence interval [CI], 0.03-0.77, for cases 2-3) or after a hospital's first one to three cases (OR, 0.19; 95% CI, 0.04-0.89, for cases 4-8; OR, 0.12; 95% CI, 0.03-0.55 for cases 9-49). CONCLUSIONS: Clinical outcomes of FEVAR across our hospital system compare favorably with previously published reports. Although system-wide FEVAR adoption increased 3-fold over the last decade, FEVAR continued to be performed by a minority of hospitals in our system. The results from this cohort demonstrate low rates of adverse events, high rates of technical efficiency, and a small impact of surgeon and hospital experience, thereby supporting this advanced endovascular technology as a safe, efficacious, and generalizable treatment alternative to open repair for patients with complex aortic anatomy.

Fate of primary determinate and indeterminate target vessel endoleaks after fenestrated-branched endovascular aortic repair.

OBJECTIVE: The aim of this study was to investigate the outcomes of primary determinate and indeterminate target vessel endoleaks (TVELs) after fenestrated-branched endovascular aortic repair (F-BEVAR). METHODS: We conducted a single-center retrospective study (2014-2023) on F-BEVAR for thoracoabdominal (TAAAs) or pararenal aortic aneurysms (PRAAs). TVELs were classified as "primary" if present at the first postoperative computed tomography angiogram. Endoleaks were defined "determinate" (dELs) if the cause (type Ic or IIIc) and implicated target vessel were identifiable and "indeterminate" (iELs) if contrast enhancement was detectable at the level of fenestrations/branches without any evident source. Endoleaks involving multiple inflows (type II and target vessels) were defined as "complex" (cELs). Endpoints were endoleak spontaneous resolution, 1-year aneurysm sac failure to regress (>5 mm diameter decrease), and 4-year endoleak-related secondary interventions. Kaplan-Meier estimates and Cox regression were used for the analysis. RESULTS: There were 142 patients with JRAAs/PRAAs (n = 85; 60%) or TAAAs (n = 57; 40%), with 513 target arteries incorporated through a fenestration (n = 294; 57%) or directional branch (n = 219; 43%). Fifty-nine primary TVELs (12%) were identified in 35 patients (25%), a dEL in 20 patients (14%) and iEL in 15 (11%); 22 (15%) had a determinate or indeterminate cEL. Overall spontaneous resolution rate was 75% (95% confidence interval [CI], 51%-87%) at 4 years. cELs (odds ratio [OR], 5.00; 95% CI, 1.10-49.4; P < .001) and iELs after BEVAR (OR, 9.43; 95% CI, 3.41-56.4; P = .002) were more likely to persist >6 months, and persistent forms were associated with sac failure to regress at 1 year (OR, 1.72; 95% CI, 1.03-12.59; P = .040). Overall freedom from endoleak-related reinterventions was 85% (95% CI, 79%-92%) at 4 years, 92% (95% CI, 87%-97%) for those without primary TVELs and 62% (95% CI, 46%-84%) for those with any primary TVEL (P < .001). In particular, cELs (hazard ratio, 1.94; 95% CI, 1.4-18.81; P = .020) were associated with an increased need for reintervention. In case a secondary intervention was needed, iEL or cEL had an increased risk for multiple secondary procedures (hazard ratio, 2.67; 95% CI, 1.22-10.34; P = .034). CONCLUSIONS: Primary TVELs are frequent after F-BEVAR, and a clear characterization of the endoleak source by computed tomography angiogram is not possible in 40% of patients. Most primary TVELs spontaneously resolve, but during follow-up, patients with any primary TVEL experience a worsened freedom from endoleak-related reinterventions that is mostly driven by persistence of cELs and post-BEVAR iELs. Multiple secondary procedures may be required in case of iELs or cELs.

Development of a comorbidity index for patients undergoing abdominal aortic aneurysm repair.

BACKGROUND: Endovascular aneurysm repair (EVAR) and open surgical repair (OSR) are two modalities to treat patients with abdominal aortic aneurysm (AAA). Alternative to individual comorbidity adjustment, a summary comorbidity index is a weighted composite score of all comorbidities that can be used as standard metric to control for comorbidity burden in clinical studies. This study aimed to develop summary comorbidity indices for patients who underwent AAA repair. METHODS: Patients who went under EVAR or OSR were identified in National Inpatient Sample (NIS) between the last quarter of 2015 to 2020. In each group, patients were randomly sampled into experimental (2/3) and validation (1/3) groups. The weights of Elixhauser comorbidities were determined from a multivariable logistic regression and single comorbidity indices were developed for EVAR and OAR groups, respectively. RESULTS: There were 34,668 patients underwent EVAR (2.19% mortality) and 4792 underwent OSR (10.98% mortality). Both comorbidity indices had moderate discriminative power (EVAR c-statistic, 0.641; 95% confidence interval [CI], 0.616-0.665; OSR c-statistic, 0.600; 95% CI, 0.563-0.630) and good calibration (EVAR Brier score, 0.021; OSR Brier score, 0.096). The indices had significantly better discriminative power (DeLong P <.001) than the Elixhauser Comorbidity Index (ECI) (EVAR c-statistic, 0.572; 95% CI, 0.546-0.597; OSR c-statistic, 0.502; 95% CI, 0.472-0.533). For internal validation, both indices had similar performance compared with individual comorbidity adjustment (EVAR DeLong P = .650; OSR DeLong P = .431). These indices demonstrated good external validation, exhibiting comparable performance to their respective validation groups (EVAR DeLong P = .891; OSR DeLong P = .757). CONCLUSIONS: ECI, the comorbidity index formulated for the general population, exhibited suboptimal performance in patients who underwent AAA repair. In response, we developed summary comorbidity indices for both EVAR and OSR for AAA repair, which were internally and externally validated. The EVAR and OSR comorbidity indices outperformed the ECI in discriminating in-hospital mortality rates. They can standardize comorbidity measurement for clinical studies in AAA repair, especially for studies with small samples such as single-institute data sources to facilitate replication and comparison of results across studies.

One-year aneurysm-sac dynamics are associated with reinterventions and rupture following infrarenal endovascular aneurysm repair.

OBJECTIVE: One-year aneurysm sac changes have previously been found to be associated with mortality and may have the potential to guide personalized follow-up following endovascular aneurysm repair (EVAR). In this study, we examined the association of these early sac changes with long-term reintervention and rupture. METHODS: We identified all patients undergoing first-time EVAR for intact abdominal aortic aneurysm between 2003 and 2018 in the Vascular Quality Initiative with linkage to Medicare claims for long-term outcomes. We included patients with an imaging study at 1 year postoperatively. Aneurysm sac behavior was defined as per the Society for Vascular Surgery guidelines: stable sac (<5 mm change), sac regression (≥5 mm), and sac expansion (≥5 mm). Outcomes included mortality, reintervention, and rupture within 8 years, which were assessed with Kaplan-Meier methods and multivariable Cox regression analysis. Secondarily, we utilized polynomial spline interpolation to demonstrate the continuous relationship of diameter change to 8-year hazard of reintervention, rupture, or mortality as a composite outcome. RESULTS: Of 31,185 EVAR patients, 16,102 (52%) had an imaging study at 1 year and were included in this study. At 1 year, 44% of sacs remained stable, 49% regressed, and 6.2% displayed expansion. Following risk adjustment, compared with a stable sac at 1 year, sac regression was associated with lower 8-year mortality (49% vs 53%; hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.85-0.99; P = .036), reintervention rate (8.9% vs 15%; HR, 0.58; 95% CI, 0.50-0.68; P < .001), and rupture rate (2.0% vs 4.0%; HR, 0.45; 95%CI, 0.29-0.69; P < .001). Conversely, compared with a stable sac, sac expansion was associated with higher 8-year mortality (64% vs 53%; HR, 1.31; 95% CI, 1.14-1.51; P < .001) and reintervention rate (27% vs 15%; HR, 1.98; 95% CI, 1.57-2.51; P < .001), but similar risk of rupture (7.2% vs 4.0%; HR, 1.61; 95% CI, 0.88-2.96; P = .12). Polynomial spline interpolation demonstrated that, compared with no diameter change at 1 year, increased sac regression was associated with an incrementally lower risk of late outcomes, whereas increased sac expansion was associated with an incrementally higher risk of late outcomes. CONCLUSIONS: Following EVAR, compared with a stable sac at 1-year imaging, sac regression and expansion are associated with a lower and higher risk respectively of long-term mortality, reinterventions, and ruptures. Moreover, the amount of regression or expansion seems to be incrementally associated with these late outcomes, too. Future studies are needed to determine how to improve 1-year sac regression, and whether it is safe to extend follow-up intervals for patients with regressing sacs.

Effect of narrow paravisceral aorta on target vessel instability after fenestrated and branched endovascular aortic repair.

OBJECTIVE: To investigate the effect of narrow paravisceral aorta (NPA) on target vessel instability (TVI) after fenestrated-branched endovascular aortic repair. METHODS: We conducted a single-center retrospective study (2014-2023) of patients treated by fenestrated-branched endovascular aortic repair for thoracoabdominal aortic aneurysms (TAAA) or pararenal aortic aneurysms. The paravisceral aorta was defined as the aortic segment limited by the diaphragmatic hiatus proximally and the emergence of lower renal artery distally, and was considered "narrow" in case of a minimum inner diameter of <25 mm. The minimum aortic diameter, location, longitudinal extension, angulation, calcification, and thrombus thickness of NPA were evaluated at the preoperative computed tomography angiogram. End points were 30-day technical success and freedom from TVI. RESULTS: There were 142 patients with JRAA/pararenal aortic aneurysm (n = 85 [59%]) and extent IV (n = 24 [17%]) or extent I-III (n = 33 [23%]) TAAA, with 513 target arteries successfully incorporated through a fenestration (n = 294 [57%]) or directional branch (n = 219 [43%]). A NPA was present in 95 patients (70%), 73 (86%) treated by fenestrated endovascular aortic repair (FEVAR) and 22 (39%) by branched endovascular aortic repair (BEVAR). The overall 30-day mortality was 2% and technical success was 99%, without differences between NPA and non-NPA (P = .99). Kaplan-Meier estimated freedom from TVI at 4 years was 82%, 81% (95% CI, 75-95) in patients with a NPA and 80% (95% CI, 68-94) and in those without NPA (P = .220). The result was maintained for both FEVAR (NPA: 81% [95% CI, 62-88]; non-NPA: 76% [95% CI, 60-99]; P = .870) and BEVAR (NPA: 77% [95% CI, 69-99]; non-NPA: 80% [95% confidence interval (CI) 66-99]; P = .100). After multivariate analysis, the concomitant presence of a NPA <20 mm and angulation of >30° was significantly associated with TVI in FEVAR (HR, 3.21; 95% CI, 1.03-48.70; P = .036), being the result mostly driven by target vessel occlusion. In BEVAR, a NPA diameter of <25 mm was not associated with TVI (HR, 2.02; 95% CI, 0.59-5.23; P = .948); after multivariate analysis, the use of outer branches in case of a NPA longitudinal extension of >25 mm (hazard ratio [HR], 3.02; 95% CI, 1.01-36.33; P = .040) and NPA severe calcification (HR, 1.70; 95% CI, 1.00-22.42; P = .048) were associated with a higher chance for TVI. CONCLUSIONS: FEVAR and BEVAR are both feasible in cases of NPA and provide satisfactory target vessels durability. The use of outer branches should be avoided in cases with an inner aortic diameter of <25 mm with a longitudinal extension of >25 mm or moderate to severe NPA calcifications. In FEVAR, bridging stent patency may be negatively influenced by NPA of <20 mm in association with aortic angulation of >30°.

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

INTRODUCTION: Custom-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. METHODS: We studied all complex endovascular repairs of complex and thoracoabdominal aortic aneurysms in the Vascular Quality Initiative from 2014 to 2022 to examine temporal trends. RESULTS: A 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. CONCLUSIONS: PMEGs 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.

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

OBJECTIVE: The 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. METHODS: A 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. RESULTS: Fifty-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%. CONCLUSIONS: The 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.

Implications and late outcomes of type II endoleaks after endovascular aneurysm repair.

OBJECTIVE: Type II endoleaks (T2ELs) are the most common cause of reintervention after endovascular aneurysm repair (EVAR). Although most resolve spontaneously, the long-term implications of T2ELs remain elusive. We aim to evaluate the impact of persistent and late T2ELs on clinical outcomes after EVAR. METHODS: This was a single-institution retrospective review of patients who underwent EVAR for degenerative infrarenal abdominal aortic aneurysm between January 2010 and June 2022 with no type I (T1EL) or III (T3EL) endoleak seen at EVAR completion. Patients were categorized based on T2EL status. Group 1 included patients with never detected or transient T2ELs (detected at EVAR completion but not after). Group 2 encompassed persistent T2ELs (seen at EVAR completion and again during follow-up) and late T2ELs (detected for the first time at any point during follow-up). Time-to-event analysis was conducted using a time-dependent approach to T2EL status. Primary outcomes included freedom from sac enlargement (SE), aneurysm-related reinterventions, and overall survival. RESULTS: A total of 803 patients met inclusion criteria. Group 1 included 418 patients (52%), of which 85% had no T2ELs and 15% had transient T2ELs. Group 2 had 385 patients; 23% had persistent T2ELs, and 77% developed a new T2EL. Patients in group 1 had a higher prevalence of smoking (88% vs 83%; P < .001), chronic obstructive pulmonary disease (33% vs 25%; P = .008), chronic kidney disease (13% vs 8%; P = .021), and a higher mean Society for Vascular Surgery score (7 vs 6 points; P = .049). No differences were found in aneurysm diameter or morphology. Mean follow-up was 5 years for the entire cohort. In Group 2, 58 patients (15%) underwent T2EL treatment, most commonly transarterial embolization. At 10 years after EVAR, Group 2 was associated with lower freedom from SE (P < .001) and abdominal aortic aneurysm-related reinterventions (P < .001) and comparable overall survival (P = .42). More T1ELs were detected during follow-up in Group 2 (6 [1%] vs 20 [5%]; P = .004), with 15 (75%) of these detected at a median of 3 years after the T2EL. No difference between groups was observed in explant (0.7% vs 2.1%; P = .130) or aneurysm rupture (0.5% vs 1.3%; P = .269) rates. CONCLUSIONS: One-half of patients treated with infrarenal EVAR developed persistent/late T2ELs, which are associated with a higher risk of SE and reinterventions. No difference in overall survival or aneurysm rupture risk was seen at 10 years, based on T2EL status or T2EL intervention. A conservative approach to T2ELs may be appropriate for most patients with absent T1ELs or T3ELs.

One-year follow-up after active aortic aneurysm sac treatment with shape memory polymer devices during endovascular aneurysm repair.

OBJECTIVE: To determine the safety and efficacy of treating abdominal aortic aneurysm (AAA) sacs with polyurethane shape memory polymer (SMP) devices during endovascular aneurysm repair (EVAR), using a technique to fully treat the target lumen after endograft placement (aortic flow volume minus the endograft volume). SMP devices self-expand in the sac to form a porous scaffold that supports thrombosis throughout its structure. METHODS: Two identical prospective, multicenter, single-arm studies were conducted in New Zealand and the Netherlands. The study population was adult candidates for elective EVAR of an infrarenal AAA (diameter of ≥55 mm in men and ≥50 mm in women). Key exclusion criteria were an inability to adequately seal a common iliac artery aneurysm, patent sac feeding vessels of >4 mm, and a target lumen volume of <20 mL or >135 mL. Target lumen volumes were estimated by subtracting endograft volumes from preprocedural imaging-based flow lumen volumes. SMP devices were delivered immediately after endograft deployment via a 6F sheath jailed in a bowed position in the sac. The primary efficacy end point was technical success, defined as filling the actual target lumen volume with fully expanded SMP at the completion of the procedure. Secondary efficacy outcome measures during follow-up were the change in sac volume and diameter, rate of type II endoleak and type I or III endoleaks, and the rate of open repair and related reinterventions, with data collection at 30 days, 6 months, and 1 year (to date). Baseline sac volumes and diameters for change in sac size analyses were determined from 30-day imaging studies. Baseline and follow-up volumes were normalized by subtraction of the endograft volume. RESULTS: Of 34 patients treated with SMP devices and followed per protocol, 33 patients were evaluable at 1 year. Preprocedural aneurysm volume was 181.4 mL (95% confidence interval [CI], 150.7-212.1 mL) and preprocedural aneurysm diameter was 60.8 mm (95% CI, 57.8-63.9 mm). The target lumen volume was 56.3 mL (95% CI, 46.9-65.8 mL). Technical success was 100% and the ratio of SMP fully expanded volume to estimated target lumen volume was 1.4 ± 0.3. Baseline normalized sac volume and diameter were 140.7 mL (95% CI, 126.6-154.9 mL) and 61.0 mm (95% CI, 59.7-62.3 mm). The adjusted mean percentage change in normalized volume at 1 year was -28.8% (95% CI, -35.3 to -22.3%; P < .001). The adjusted mean change in sac diameter at 1 year was -5.9 mm (95% CI, -7.5 to -4.4 mm; P < .001). At 1 year, 81.8% of patients (95% CI, 64.5%-93.0%) achieved a ≥10% decrease in normalized volume and 57.6% of patients (95% CI, 39.2%-74.5%) achieved a ≥5 mm decrease in diameter. No device- or study procedure-related major adverse events occurred through 1 year after the procedure. CONCLUSIONS: Treatment of AAA sacs with SMP devices during EVAR resulted in significant sac volume and diameter regression at 1 year with an acceptable safety profile in this prospective study.

Ten-year single-center outcomes following endovascular repair for abdominal aortic aneurysm using the INCRAFT device.

OBJECTIVE: This study aimed to report the long-term outcomes beyond 10 years of endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms using the low-profile INCRAFT device. METHODS: This was a single-center, retrospective cohort study of all patients undergoing EVAR using the INCRAFT device as part of the regulatory trial between 2012 and 2013. Primary endpoint was aneurysm-related death. Secondary endpoints were all-cause death, reintervention, late open conversion, and aneurysm status (shrinkage, stable, and growth). RESULTS: Thirty patients with a mean age of 71.8 ± 7.7 years were included in this study. The median aneurysm diameter at EVAR was 54.5 mm (interquartile range, 53-56.8 mm). All abdominal aortic aneurysms in this study were treated following the device's instructions for use. At index EVAR, the INCRAFT device was successfully implanted in all patients using a percutaneous approach under local anesthesia. No patients experienced major adverse events or procedure-related complications 30 days after EVAR. During the median follow-up of 125 months (interquartile range, 98-131 months) with follow-up rates of 100% at 5 years and 96.7% at 10 years, aneurysm-related mortality was 0%, and freedom from all-cause mortality was 82.9% at 5 years and 75.3% at 10 years. Reintervention was required in 10 patients with 15 procedures. Sac growth was observed in 11 patients (36.7%), six of whom eventually required late open conversion; five of these patients underwent open aneurysmorrhaphy with stent graft preservation, and one underwent open surgical repair with endograft explantation. Late rupture was identified in one case, where type Ia endoleak led to rupture at 69 months, and open repair was successfully performed. Freedom from reintervention was 89.0% at 5 years but declined to 60.9% at 10 years; freedom from late open conversion was 100% at 5 years but declined to 70.8% at 10 years. CONCLUSIONS: Long-term outcomes of the INCRAFT stent graft showed no aneurysm-related deaths. However, sac growth occurred persistently throughout the follow-up period, resulting in a relatively high rate of reinterventions in the later periods, which highlights the importance of lifelong postoperative surveillance and appropriate reinterventions when indicated.

Midterm outcomes of endovascular repair for abdominal aortic aneurysm using the cuff-first technique to prevent type II endoleaks.

OBJECTIVE: The aim of this study was to evaluate the initial and midterm outcomes of endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) using the cuff-first technique (CFT) to prevent type II endoleak (T2EL). METHODS: CFT involves deploying an aortic cuff inside the AAA to cover the ostium of the aortic side branch vessels before deploying the main body. We performed a retrospective review of all patients undergoing EVAR with CFT or side branch embolization (SBE) for AAAs at The Jikei University Hospital between 2016 and 2022. Primary endpoint was the rate of aneurysm sac shrinkage. Secondary endpoints were procedure time, radiation exposure, technical and clinical success rates, occurrence of T2EL, and freedom from reintervention or aneurysm-related death. RESULTS: Of 406 patients who underwent EVAR for AAAs, CFT was utilized in 56 (CFT group) and SBE in 35 (SBE group); all 91 patients were included in this study. There were no differences in patient demographics between groups, but there were differences in patency rate of the inferior mesenteric artery and absent intraluminal thrombus. The technical success rate per target vessel in the CFT and SBE group was 97.8% and 91.8%, and the clinical success rate was 91.0% and 100%, respectively. The median procedure time was shorter for CFT than for SBE: CFT, 10 (interquartile range [IQR], 6-14) minutes vs SBE, 25 (IQR, 18.5-45) minutes; P < .05), and median radiation exposure was lower for CFT than for SBE (CFT, 1455 (IQR, 840-2634) mGy vs SBE, 2353 (IQR, 1552-3586) mGy; P < .05). During the median follow-up of 25 months (IQR, 12.5-47 months), sac shrinkage occurred at similar rates in both groups (CFT, 37.5% vs SBE, 40.0%; P = .812), and there were no differences in freedom from reintervention (CFT, 96.2% and 91.4% at 12 and 36 months vs SBE, 100% and 89.5% at 12 and 36 months; log-rank P = .761) and freedom from aneurysm-related death (100% at 36 months in both groups; log-rank P = .440). The odds ratio of CFT vs SBE for sac regression was calculated by adjusting for inferior mesenteric artery patency and absent intraluminal thrombus, resulting in no statistical significance (odds ratio, 1.231; 95% confidence interval, 0.486-3.122). CONCLUSIONS: CFT is feasible with a shorter procedure time and lower radiation exposure than SBE and comparable mid-term outcomes, including sac shrinkage rate, compared with SBE. We believe that CFT, if anatomically suitable, is an alternative to SBE for the prevention of T2EL during EVAR.

Predictors for reintervention and survival during long-term follow-up after TEVAR for descending thoracic aortic aneurysm.

BACKGROUND: Several studies have reported short- and intermediate-term outcomes after TEVAR for descending thoracic aortic aneurysm (DTAA), however, reports on long-term (10 years) outcomes are sparse. Therefore, the aim of this study was to analyze predictors impacting long-term outcome following thoracic endovascular aortic repair (TEVAR) for DTAA. MATERIALS AND METHODS: Databases from four academic institutions were reviewed and consecutive cases of TEVAR for DTAA between 1999 and 2021 were included in this retrospective multicenter study (Case series). Ethical approval from Institutional review board was obtained and patient demographics, treatment data as well as follow-up information were retrieved and analyzed. RESULTS: 305 patients (mean age 72±10 years) treated with TEVAR for degenerative DTAA with mean aortic diameter of 64mm were identified. Altogether 445 endografts were implanted via femoral access (93%) with a technical success of 94%. Operative mortality, stroke rate and rate of spinal cord ischemia were 6% (5% for intact, 12% for ruptured DTAA), 4% and 3%, respectively. Kaplan-Meier estimates for overall survival rates were 76%, 59% and 34% at 1, 5 and 10 years and freedom from reintervention rates were 84%, 73% and 58% at 1, 5 and 10 years, respectively. In multivariate analysis, ASA grade 3-5 and non-elective case were identified as predictors for death, wheres as fusiform DTAA, proximal landing zone 2 and hypertension but not device generation were predictive for reintervention. CONCLUSION: This is to date the largest study reporting long-term (10 years) outcome on TEVAR for DTAA. We found acceptable rates for long-term survival and freedom-from reintervention that were independent of endovascular device generation.

Systematic review and meta-analysis of outcomes after semi-conversion with graft preservation for failed endovascular aneurysm repair.

OBJECTIVE: The aim of this study was to evaluate the outcomes after semi-conversion (open conversion with graft preservation) after failed endovascular aneurysm repair (EVAR). The primary outcomes were 30-day mortality and semi-conversion failure. Secondary outcomes were 30-day major systemic complications, endoleak recurrence, reinterventions, and overall survival. METHODS: The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The protocol was prospectively registered on PROSPERO (CRD42023421153). All studies reporting the outcomes of semi-conversions for failed EVAR were eligible for inclusion. Quality assessment was performed using the Methodological Index for Non-Randomized Studies (MINORS) tool. A random effects meta-regression of proportions was conducted using the double arcsine-Tukey transformation, given the frequent zero event rate in the primary outcome. Heterogeneity was assessed with the I2 statistic. RESULTS: Eight studies were included in the review after full text screening. A total of 196 patients underwent semi-conversion at a mean time from EVAR of 47.4 months, 68.9% in an elective setting. Mean age at conversion was 78.1 years, and the main indication was isolated endoleak type II (70.1% of cases). Aortic clamping was not necessary in 92.3% of semi-conversions; the aortic sac was opened in 96.1% of cases; in 93.3% of cases, ligation/suture of one or more culprit arteries were performed; and aortic neck banding was executed in 29.2%. At 30 days from surgery, the pooled mortality and the major systemic complications rates were 5.3% (I2 = 24.9%) and 13.4% (I2 = 54.3%), respectively. At follow-up, endoleak recurred after 12.6% semi-conversions (I2 = 83.2%), and the rate of reinterventions was 7% (I2 = 50.1%); the semi-conversion failure rate was 5.5% (I2 = 54.1%), and the overall survival was 84.6% (I2 = 33.3%). CONCLUSIONS: Semi-conversions have acceptable 30-day mortality rates, but the early and mid-term risks of complications, reinterventions, ruptures, and infections are not negligible. This procedure might be an alternative to complete or partial graft explant in patients whom aortic cross-clamping is not ideal.

Midterm outcomes of side branch embolization and endovascular abdominal aortic aneurysm repair.

OBJECTIVE: To analyze the effects of total side branch embolization at endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms on the incidences of persistent type 2 endoleak (pT2EL), changes in sac diameter, and reintervention. METHODS: Between 2013 and 2021, all patients who underwent primary EVAR with a few exceptions were included. Side branch embolization was considered during EVAR for inferior mesenteric artery (IMA) or IMA plus lumbar artery (LA) when feasible for contrast agent use. Outcomes measured were pT2EL, sac diameters, reintervention, ruptures, and aneurysm-related mortality. Radiation exposure and safety outcomes were also reported. RESULTS: Among 732 patients who underwent EVAR, 616 (84.2%) were included. Of the 616 patients, 223 (36.2%) did not undergo side branch embolization (NO-E), whereas 228 (37.0%) underwent IMA only (IMA-E) and 165 (26.8%) underwent IMA+LA including median sacral artery (IMA+LA-E). The technical success rate of IMA and LA embolization was 97.0% and 74.7%, respectively. Crude incidences of pT2EL were significantly different from 6 months through 3 years (NO-E, 27.8%; IMA-E, 31.7%; IMA+LA-E, 9.4% at 3 years; P = .007). In the multivariate analysis adjusted for background differences, the incidences of pT2EL were significantly higher in the NO-E (odds ratio [OR], 3.21; 95% confidence intervals [CIs], 1.08-9.57; P = .004) and IMA-E (OR, 4.86; 95% CIs, 1.68-14.11; P = .004) compared with the IMA+LA-E group. Similarly, any reintervention until 3 years was significantly frequent in the NO-E (OR, 5.26; 95% CIs, 1.76-15.70; P = .003) and IMA-E group (OR, 4.19; 95% CIs, 1.38-12.67; P = .01). Surgical conversion and secondary rupture were seen only in 1 patient without any aneurysm-related mortality. Percent sac shrinkage from the baseline was significantly promoted in the IMA+LA group (NO-E, 12.1% ± 16.6%; IMA-E, 11.4% ± 16.7%; IMA+LA-E, 18.0% ± 18.8%; P = .047). Fluoroscopy time was significantly longer in the IMA+LA-E group (NO-E, 60.2 ± 47.4 minutes; IMA-E, 59.3 ± 39.5 minutes; IMA+LA-E, 75.5 ± 42.8 minutes; P < .0001), and so do the dose-area product (NO-E, 424.6 ± 333.4 Gy cm2; IMA-E, 477.7 ± 342.4 Gy cm2; IMA+LA-E, 631.8 ± 449.1 Gy cm2; P < .0001). No embolization-related complications or radiation-related adverse events were recorded. CONCLUSIONS: Pre-emptive embolization of IMA, LAs, and median sacral artery at the time of EVAR reduced the incidences of pT2EL and any reintervention and promoted sac shrinkage during the follow-up period of 3 years.

Descending thoracic aortic mural ulceration is associated with postoperative spinal cord ischemia after branched endovascular aortic aneurysm repair.

OBJECTIVE: Paraplegia is one of the most feared complications after thoracoabdominal aortic aneurysm repair. The purpose of this study is to determine whether aortic thrombus characteristics are associated with spinal cord ischemia (SCI) after branched endovascular aneurysm repair (BEVAR). METHODS: From April 2011 to April 2020, 62 patients underwent elective BEVAR for thoracoabdominal aortic aneurysm and pararenal aortic aneurysms using a low-profile device and had a complete preoperative computed tomography angiography of the aorta from the sinotubular junction to the aortic bifurcation. Aortic thrombus was evaluated for thrombus thickness ≥5 mm, thrombus >2/3 of aortic circumference, and the presence of an ulcer-like thrombus. One point was assigned at each 5 mm axial image if all 3 criteria were met, resulting in a total "shaggy score" for the entire aorta. Data on demographics, procedural details, and outcomes were collected prospectively. All patients underwent a standard spinal cord protection protocol, including routine cerebrospinal fluid drainage. In July 2016, an insulin infusion protocol (IIP) was initiated to maintain postoperative blood glucose levels <120 mg/dL for 48 hours. The primary clinical end point was postoperative SCI. RESULTS: 10 (16%) patients developed postoperative SCI: 6 with transient paraparesis, 2 with persistent paraparesis, and 2 with persistent paraplegia. Patients with SCI were older, had higher shaggy scores, and were less likely to have been on an IIP. There were no significant differences in demographics, aneurysm type, or operative parameters. In a logistic multivariate regression model for SCI, age (odds ratio [OR]: 1.2 [1.1-1.4], P = .02) and shaggy score (OR: 1.2 [1.1-1.4], P = .02) were independently associated with increased risk of SCI, whereas treatment with the IIP was associated with lower risk of SCI (OR: 0.04 [0.006-0.50], P = .05). Of the individual components of the shaggy score, higher descending thoracic aortic ulcer scores were the most strongly associated with postoperative SCI (P = .009). CONCLUSIONS: Preoperative characterization of aortic wall thrombus is an important adjunctive tool for individualized clinical decision-making and patient counseling about the risk of SCI after BEVAR.

Initial two-day blood pressure management after endovascular aneurysm repair improves midterm outcomes by reducing the incidence of early type II endoleak.

OBJECTIVE: The aim of this study was to evaluate midterm outcomes of our novel strategy of postoperative initial 2-day blood pressure management (BPM) after endovascular aneurysm repair (EVAR) for the prevention of subsequent type II endoleak (T2EL) in a single-center series. METHODS: Between 2008 and 2014, 137 patients who underwent EVAR for abdominal aortic aneurysm (AAA) were reviewed. Starting from 2013, the mean blood pressure was maintained between 75 and 90 mmHg for the initial 24 hours after EVAR followed by systolic pressure controlled below 120 mmHg during the next 24 hours in the treatment group (n = 76). The incidence of T2EL detected at 7 days, reintervention, and AAA sac diameter up to 5 years after EVAR were compared with those of the control group comprising of 60 consecutive patients who underwent standard EVAR without BPM prior to 2013. RESULTS: Between the treatment group and the control group, significant differences were achieved in the incidence of T2EL at 7 days (19.7% vs 40.0%; P = .009), a mean decrease of AAA sac diameter at 1-year (-5.1 ± 4.9 vs -2.2 ± 6.7 mm; P = .013) and 2-year (-5.4 ± 7.7 vs -1.7 ± 10.8 mm; P = .045). In addition, there was a significant decrease in the incidence of T2EL detected at 7 days with the use of the Gore Excluder with 22.7% in the treatment group vs 80.0% in the control group (P < .001), which resulted in a significant decrease in the aneurysm sac diameter up to 4 years after EVAR. Survival rate without AAA sac enlargement at 5 years after EVAR (83.0% vs 70.0%; P = .021) in the treatment group was significantly higher than that of the control group, whereas no significant differences were observed in the freedom rates of reintervention, T2EL-related reintervention, and all-cause mortality between the groups. CONCLUSIONS: Postoperative initial 2-day BPM had a preventive effect on AAA sac enlargement until midterm periods, by reducing the incidence of T2EL at 7 days after EVAR. The usage of Gore Excluder under BPM was especially associated with sustained positive effects until the midterm follow-up.