Thoracoabdominal aneurysm repair using the Unitary Manifold Device.

OBJECTIVE: To present a single-center prospective study of 126 consecutively treated patients who underwent endovascular repair of a thoracoabdominal aortic aneurysm with the physician-modified, nonanatomic-based Unitary Manifold (UM) device. METHODS: Data were collected from 126 consecutive all-comer patients treated with the physician-modified, nonanatomic-based UM from 2015 to 2023. Treatment was performed at a single center by a single physician under a Physician Sponsored Investigation Exemption G140207. RESULTS: The UM was indicated for repair of all Crawford extents including juxtarenal, pararenal, and short-neck infrarenal aneurysms (<10 mm) in 126 consecutive patients. Patients were not excluded from the study based on presentation, extent of aneurysm or dissection, or history of a spinal cord event. Patients with a thoracoabdominal aortic aneurysm were categorized by Crawford classification: types I and V (3.3%, n = 4), type II (3.3%, n = 4), type III (1%, n = 1), and type IV (93.3%, n = 117). The type IV classification patients were further categorized with 33 (28.2%) true type IV, 68 (58.1%) pararenal or infrarenal, and 16 (13.7%) with dissection. Technical success was 99.2% (n = 125). The most common major adverse event within both 30 days and 365 days of all patients was respiratory failure (11.9%, n = 15, and 13.5%, n = 17, respectively). One patient (0.8%) experienced persistent paraplegia at 365 days. Reintervention for patients at 365 days was 5.6% (n = 7). Of the 444 branches stented, the primary patency rate was remarkably high as only three patients (2.4%) required reintervention due to loss of limb patency within 365 days. Aneurysm enlargement (≥5 mm) occurred in 1.6% (n = 2) patients, and no patients experienced aneurysm rupture. No patients underwent conversion to open repair. The aneurysm-related mortality at 365 days for all patients was 4.0% (n = 5), whereas all-cause mortality was 16.7% (n = 21). Physician-modified endograft device integrity failure was not observed in any patient. CONCLUSIONS: The UM device demonstrated remarkable technical surgical success, treatment success, and device patency rates with very reasonable major adverse events and reintervention rates. This study is the most representative example of the general population in comparison with other studies of off-the-shelf devices, with 126 consecutive all-comer patients with diverse pathologies.

Prognostic factors after open and endovascular repair for infected native aneurysms of the abdominal aorta and common iliac artery.

OBJECTIVE: Infected native aneurysms (INAs) of the abdominal aorta and iliac arteries are uncommon, but potentially fatal. Endovascular aneurysm repair (EVAR) has recently been introduced as a durable treatment option, with outcomes comparable to those yielded by conventional open repair. However, owing to the rarity of the disease, the strengths and limitations of each treatment remain uncertain. The present study aimed to separately assess post-open repair and post-EVAR outcomes and to clarify factors affecting the short-term and late prognosis after each treatment. METHODS: Using a nationwide clinical registry, we investigated 600 patients treated with open repair and 226 patients treated with EVAR for INAs of the abdominal aorta and/or common iliac artery. The relationships between preoperative or operative factors and postoperative outcomes, including 90-day and 3-year mortality and persistent or recurrent aneurysm-related infection, were examined. RESULTS: Prosthetic grafts were used in >90% of patients treated with open repair, and in situ and extra-anatomic arterial reconstruction was performed in 539 and 57 patients, respectively. Preoperative anemia and imaging findings suggestive of aneurysm-enteric fistula were independently associated with poor outcomes in terms of both 3-year mortality (hazard ratio [HR], 1.62; 95% confidence interval [CI], 1.01-2.62; P = .046, and HR, 2.24; 95% CI, 1.12-4.46; P = .022, respectively) and persistent or recurrent infection (odds ratio [OR], 2.16; 95% CI, 1.04-4.49; P = .039, and OR, 4.96; 95% CI, 1.81-13.55; P = .002, respectively) after open repair, whereas omental wrapping or packing and antibiotic impregnation of the prosthetic graft for in situ reconstruction contributed to improved 3-year survival (HR, 0.60; 95% CI, 0.39-0.92; P = .019, and HR, 0.53; 95% CI, 0.32-0.88; P = .014, respectively). Among patients treated with EVAR, abscess formation adjacent to the aneurysm was significantly associated with the occurrence of persistent or recurrent infection (OR, 2.24; 95% CI, 1.06-4.72; P = .034), whereas an elevated preoperative white blood cell count was predictive of 3-year mortality (HR, 1.77; 95% CI, 1.00-3.13; P = .048). CONCLUSIONS: Profiles of prognostic factors differed between open repair and EVAR in the treatment of INAs of the abdominal aorta and common iliac artery. Open repair may be more suitable than EVAR for patients with concurrent abscess formation.

Impact of chronic kidney disease and end-stage renal disease on outcomes after complex endovascular and open aortic aneurysm repair.

OBJECTIVE: Chronic kidney disease (CKD) and end-stage renal disease are traditionally associated with worse outcomes after endovascular aortic repair (EVAR) and open aneurysm repair (OAR) of abdominal aortic aneurysms (AAAs). However, there needs to be more data on complex AAA repair involving the aorta's visceral segment. This study stratifies complex AAA repair outcomes by CKD severity and dialysis dependence. METHODS: All patients undergoing elective OAR and fenestrated/branched EVAR (F-BEVAR) for complex AAA with preoperative renal function data captured by the Vascular Quality Initiative between January 2003 and September 2020 were analyzed. Patients were stratified by CKD class as follows: normal/mild (CKD 1 and 2), moderate (CKD class 3a), moderate to severe (CKD 3b), severe (CKD class 4 and 5), and dialysis. Only patients with clamp sites above one of the renal arteries were included for complex OAR. For F-BEVAR, patients with proximal landing zones below zone 5 (above celiac artery) were included, and distal landing zones between zones 1 and 5 were excluded. Primary outcomes were perioperative and 1-year mortality. Predictors of mortality were identified by Cox multivariate regression models. RESULTS: We identified 7849 elective complex AAA repairs: 4230 (54%) complex OARs and 3619 (46%) F-BEVARs. Most patients were White (89%) and male (74%), with an average age of 72 ± 8 years. The patients who underwent F-BEVAR were older and had more comorbidities. Elective F-BEVAR for complex AAA started in 2012 and increased from 1.4% in 2012 to 58% in 2020 (P < .001). The OAR cohort had more perioperative complications, but less 1-year mortality. The normal/mild CKD cohort had the highest 1-year survival compared with other groups after both complex OAR and F-BEVAR. On Cox regression analysis, when compared with CKD 1-2, worsening CKD stage (CKD 3b: hazard ratio [HR], 2.5; 95% confidence interval [CI], 1.82-3.40; P < .001; CKD 4-5: HR, 1.9; 95% CI, 1.16-3.26; P = .011; and dialysis: HR, 4.4; 95% CI, 2.53-7.72; P < .001) were independently associated with 1-year survival after F-BEVAR. After complex OAR, worsening CKD stage but not dialysis was associated with 1-year mortality compared with CKD 1-2 (CKD 3b: HR, 1.6; 95% CI, 1.13-2.35; P = .009; CKD 4-5: HR, 3.4; 95% CI, 2.03-5.79; P < .001). CONCLUSIONS: CKD severity is an essential predictor of perioperative and 1-year mortality after complex AAA repair, irrespective of the treatment modality, which may reflect the natural history of CKD. Consideration should be given to raising the threshold for elective AAA repair in patients with moderate to severe CKD and end-stage renal disease, given the high 1-year mortality rate.

Total aortic arch repair with double-fenestrated physician-modified endografts, at least 3-year follow-up.

OBJECTIVE: This study aims to report the efficacy and safety of double-fenestrated physician-modified endovascular grafts (PMEGs) for total aortic arch repair with at least 3 years of follow-up. METHODS: All consecutive patients with a pathological aortic arch who underwent aortic arch repair combined with a homemade double-fenestrated stent graft from 2017 to 2020 were reviewed. RESULTS: 74 patients were treated for pathological arch conditions with a double-fenestrated PMEG. Of these, 81% were male, the mean age was 69.9 years, and 59% were classified as American Society of Anesthesiology 3 or 4. Thirty-five percent were treated for a postdissection aneurysm, 36% for a degenerative aneurysm, and 14% for acute type B dissection. Fifteen percent had supra-aortic trunk dissection. Fenestration on the subclavian artery was performed in 96%; if not, a carotid-subclavian bypass was carried out. Technical success was 100%. The proximal landing zone is consistently in zone 0. Early outcomes revealed a 3% occurrence of type 1 endoleak, which was successfully treated by prompt reintervention. One retrograde dissection occurred, and one patient died from hemorrhage on an iliac conduit. A 5% stroke rate was reported. During long-term follow-up (mean time 40.7 months), one type 1 endoleak appeared and was successfully treated; no type 2 or type 3 endoleak requiring intervention occurred. No stent fractures or migrations were reported. Four percent of patients required reintervention, but no surgical conversion to open surgical repair was needed on the aortic arch. No patient died from a cause related to the main procedure. CONCLUSIONS: Total aortic arch repair with double-fenestrated PMEGs is associated with acceptable early and midterm major morbidity and mortality. It is suitable for the main aortic pathologies. Moreover, it is easily available for emergency situations.

Early Experience with Patient-Specific Unibody Bifurcated Fenestrated-Branched Devices for Complex Endovascular Aortic Aneurysm Repair.

OBJECTIVE: Short distances between the lowest visceral/renal artery and the aortic bifurcation are technically challenging during complex endovascular aortic aneurysm repair (EVAR), particularly after previous infrarenal repair. Traditionally, inverted limb bifurcated devices have been used in addition to fenestrated-branched (FB) endografts, but short overlap, difficult cannulation, and potential crushing of bridging stents are limitations for their use. This study reviews the early experience of patient-specific company manufactured devices (PS-CMD) with a unibody bifurcated FB design for complex EVAR. METHODS: Consecutive complex EVAR procedures over a 34-month period with unibody bifurcated FB-devices as part of physician-sponsored investigational device exemption studies at two institutions were reviewed. Unibody bifurcated FB-designs included fenestrated-branched bifurcated or fenestrated inverted limb devices. Endpoints included technical success, survival, frequency of type I or III endoleaks, limb occlusion, and secondary interventions. RESULTS: Among 168 patients undergoing complex EVAR, 33 (19.6%) patients (78.7% male; mean age 77) received unibody bifurcated FB PS-CMDs. Fenestrated-branched bifurcated and fenestrated inverted limb devices were used in 31 (93.9%) and 2 (6.06%) patients, respectively. Median maximum aneurysm diameter was 61 mm (interquartile range [IQR] 55-69). Prior EVAR was reported by 29 (87.9 %) patients, of which 2 (6.06%) had suprarenal stents. A short distance between the lowest renal artery and aortic bifurcation was demonstrated in 30 (90.9%) patients, with median distance of 47 mm (IQR 38-54). Preloaded devices were used in 23 patients (69.7%). A total of 128 fenestrations were planned; 22 (17.2%) were preloaded with guidewires, and 5 (3.9%) with catheters. The median operative time was 238 min (226-300), with a median fluoroscopy time of 65.5 min (IQR 56.0-77.7) and a median dose area product of 147 mGy*cm2 (IQR 105-194). Exclusive femoral access was used in 14 (42.4%) procedures. Technical success was 100%. Target vessel primary patency was 100% at median follow-up time of 11.7 months (IQR 3.5-18.6). Two (6.06%) patients required reintervention for iliac occlusion; one patient required stenting and the other a femoral-femoral bypass. No aortic-related deaths occurred after the procedure. During follow-up, 11 (33.3 %) type II endoleaks and one (3.03%) type Ib endoleak were detected; the latter was treated with leg extension. No type Ia or III endoleaks occurred. CONCLUSION: Complex EVAR using unibody bifurcated FB-PS-CMDs is a simple, safe, and cost-effective alternative for the treatment of patients with short distances between the renal arteries and the aortic bifurcation. Further studies are required to assess benefits and durability of unibody bifurcated FB-devices.

Examining the impact of median arcuate ligament-induced celiac artery compression on target vessel patency, long-term survival and device integrity in fenestrated and branched endovascular repairs.

OBJECTIVE: To evaluate the impact of celiac artery (CA) compression by median arcuate ligament (MAL) on technical metrics and long-term CA patency in patients with complex aortic aneurysms undergoing fenestrated/branched endograft repairs (F/B-EVARs). METHODS: Single-center, retrospective review of patients undergoing fenestrated/branched endovascular aortic aneurysm repairs and requiring incorporation of the CA between 2013 and 2023. Patients were divided into two groups-those with (MAL+) and without (MAL-) CA compression-based on preoperative computed tomography angiography findings. MAL was classified in three grades (A, B, and C) based on the degree and length of stenosis. Patients with MAL grade A had ≤50% CA stenosis measuring ≤3 mm in length. Those with grade B had 50% to 80% CA stenosis measuring 3 to 8 mm long, whereas those with grade C had >80% stenosis measuring >8 mm in length. End points included device integrity, CA patency and technical success-defined as successful implantation of the fenestrated/branched device with perfusion of CA and no endoleak. RESULTS: One hundred and eighty patients with complex aortic aneurysms (pararenal, 128; thoracoabdominal, 52) required incorporation of the CA during fenestrated/branched endovascular aortic aneurysm repair. Majority (73%) were male, with a median age of 76 years (interquartile range [IQR], 69-81 years) and aneurysm size of 62 mm (IQR, 57-69 mm). Seventy-eight patients (43%) had MAL+ anatomy, including 33 patients with MAL grade A, 32 with grade B, and 13 with grade C compression. The median length of CA stenosis was 7.0 mm (IQR, 5.0-10.0 mm). CA was incorporated using fenestrations in 177 (98%) patients. Increased complexity led to failure in CA bridging stent placement in four MAL+ patients, but completion angiography showed CA perfusion and no endoleak, accounting for a technical success of 100%. MAL+ patients were more likely to require bare metal stenting in addition to covered stents (P = .004). Estimated blood loss, median operating room time, contrast volume, fluoroscopy dose and time were higher (P < .001) in MAL+ group. Thirty-day mortality was 3.3%, higher (5.1%) in MAL+ patients compared with MAL- patients (2.0 %). At a median follow-up of 770 days (IQR, 198-1525 days), endograft integrity was observed in all patients and CA events-kinking (n = 7), thrombosis (n = 1) and endoleak (n = 2) -occurred in 10 patients (5.6%). However, only two patients required reinterventions. MAL+ patients had overall lower long-term survival. CONCLUSIONS: CA compression by MAL is a predictor of increased procedural complexity during fenestrated/branched device implantation. However, technical success, long-term device integrity and CA patency are similar to that of patients with MAL- anatomy.

Variability in short-term mortality following repair of ruptured abdominal aortic aneurysms across centers and physicians.

BACKGROUND: Variation in the care management of repairs for ruptured infrarenal abdominal aortic aneurysms between centers and physicians, such as procedural volumes, may explain differences in mortality outcomes. First, we quantified the center and physician variability associated with 30- and 90-day mortality risk after ruptured open surgical repair (rOSR) and ruptured endovascular aneurysm repair (rEVAR). Second, we explored wheter part of this variability was attributable to procedural volume at the center and physician levels. METHODS: Two cohorts including rOSR and rEVAR procedures between 2013 and 2019 were analyzed from the Vascular Quality Initiative database. Thirty- and 90-day all-cause mortality rates were derived from linked Medicare claims data. The median odds ratio (MOR) (median mortality risk from low- to high-risk cluster) and intraclass correlation coefficient (ICC) (variability attributable to each cluster) for 30- and 90-day mortality risks associated with center and physician variability were derived using patient-level adjusted multilevel logistic regression models. Procedural volume was calculated at the center and physician levels and stratified by quartiles. The models were sequentially adjusted for volumes, and the difference in ICCs (without vs with accounting for volume) was calculated to describe the center and physician variability in mortality risk attributable to volumes. RESULTS: We included 450 rOSRs (mean age, 74.5 ± 7.6 years; 23.5% female) and 752 rEVARs (76.4 ± 8.4 years; 26.1% female). After rOSRs, the 30- and 90-day mortality rates were 32.9% and 38.7%, respectively. No variability across centers and physicians was noted (30- and 90-day MORs ≈1 and ICCs ≈0%). Neither center nor physician volume was associated with 30-day (P = .477 and P = .796) or 90-day mortality (P = .098 and P = .559). After rEVAR, the 30- and 90-day mortality rates were 21.3% and 25.5%, respectively. Significant center variability (30-day MOR, 1.82 [95% confidence interval (CI), 1.33-2.22]; ICC, 11% [95% CI, 2%-36%]; and 90-day MOR, 1.76 [95% CI, 1.37-2.09]; ICC, 10% [95% CI, 3%-30%]), but negligeable variability across physicians (30- and 90-day MORs ≈1 and ICCs ≈0%) were noted. Neither center nor physician volume were associated with 30-day (P = .076 and P = .336) or 90-day mortality risk (P = .066 and P = .584). The center variability attributable to procedural volumes was negligeable (difference in ICCs, 1% for 30-day mortality; 0% for 90-day mortality). CONCLUSIONS: Variability in practice from center to center was associated with short-term mortality outcomes in rEVAR, but not for rOSR. Physician variability was not associated with short-term mortality for rOSR or rEVAR. Annualized center and physician volumes did not significantly explain these associations. Further work is needed to identify center-level factors affecting the quality of care and outcomes for ruptured abdominal aortic aneurysms.

Branched and fenestrated endovascular aortic arch repair in patients with native proximal aortic landing zone.

OBJECTIVE: Fenestrated and branched thoracic endovascular repair (f/bTEVAR) have been successfully applied in patients with diverse aortic arch pathologies. The aim of this study is to present the early and mid-term outcomes of patients with native proximal aortic landing (NPAL) managed with f/bTEVAR. METHODS: A single-center retrospective analysis of patients with NPAL, managed with f/bTEVAR, between September 1, 2011, and June 30, 2022, was conducted. All patients were treated with custom-made devices (Cook Medical) with landing within Ishimaru zones 0 to 2. Primary outcomes were technical success, mortality, stroke, and retrograde type A dissection at 30 days. Follow-up outcomes were considered secondary. RESULTS: A total of 126 patients were included (69.8% males; mean age, 70.8 ± 4.2 years; 18.3% urgent). The main indications (60.4%) for repair were aortic arch (29.4%) and thoracoabdominal aortic aneurysms (31.0%). Seventy-two patients (57.1%) were managed with fTEVAR. Proximal landing in zone 0 and 1 was chosen in 97.6%. Technical success was 94.4%, and 30-day mortality was 11.9%. Strokes were diagnosed in 13.5% of patients and major strokes were identified in 7.9% cases. Retrograde type A dissection rate was 3.9%. The multivariate analysis confirmed landing in Ishimaru zone 0 as an independently related factor for stroke (P = .005), whereas stroke (P < .001), pericardial effusion (P < .001), and acute kidney injury (P < .001) were independently related to 30-day mortality. Mean follow-up was 17.5 ± 9.3 months. The estimated survival rate and the freedom from reintervention rate were 72.6% (standard error, 4.4%) and 46.4% (standard error, 6.0%) at 24-month follow-up, respectively. CONCLUSIONS: Stroke rate after endovascular arch repair was alarming among patients with NPAL. Proximal landing to zone 0 was related to higher risk of stroke. Reinterventions were common within the 24-month follow-up.

Early outcomes from the pivotal trial of a four-branch off-the shelf solution to treat complex abdominal and type IV thoracoabdominal aortic aneurysms.

BACKGROUND: This study reports the 30-day outcomes of the primary arm of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) pivotal trial for complex abdominal aortic aneurysm repair. METHODS: This multicenter, nonrandomized, prospective study of the TAMBE device included patients enrolled in the primary study arm of extent IV thoracoabdominal aortic aneurysms and pararenal aneurysms. Technical success and major adverse events were analyzed per the Society for Vascular Surgery guidelines. RESULTS: The 102 patients of the primary arm who underwent endovascular repair using the TAMBE device were a mean age of 73 ± 6.4 years (range, 58-82 years) and 84 (84.2%) were male. The mean body mass index was 28.3 ± 5.0 kg/m2. Fifty-nine patients (57.8%) were treated for extent IV and 43 (42.2%) pararenal aneurysms; the mean maximum diameter of the aneurysms was 59.4 ± 7.8 mm. A prophylactic cerebral spinal fluid drain was used in 10 patients (9.8%). Technical success was achieved in 99% of patients, with the single failure owing to unsuccessful cannulation of the left renal artery. Mean procedure time was 315 ± 103 minutes (range, 163-944 minutes), estimated blood loss was 300 ± 296 mL (range, 10-2000 mL), and contrast administration was 153.6 ± 73.5 mL (range, 16-420 mL). The intensive care unit length of stay was 58.7 ± 52.7 hours (range, 1-288 mL). In 28 patients (27.5%), a total of 32 additional endovascular components were deployed to manage procedural complications including aortic and target vessel dissections and injuries not related to access. Bridging stent grafts were deployed to incorporate 407 target vessels (mean 1.6/per vessel; range, 1-4). Postoperative transfusion was required in 14 patients (13.7%). Major adverse events occurred in seven patients (6.9%) through 30 days. Events included respiratory failure (n = 2), disabling stroke (n = 1), new-onset renal failure requiring dialysis (n = 2), and paraplegia (n = 2). At 30 days, there was one patient with intraoperative rupture; no severe bowel ischemia or lesion-related/all-cause mortality were reported. The Core lab-reported patency was 100% in the aortic component, superior mesenteric artery, and celiac artery, and 95.9% in the left renal and 99.0% in the right renal branch components through 30 days of follow-up. Reinterventions through 30 days were performed in 9 of 96 patients (9.4%) and were all minor. CONCLUSIONS: Early TAMBE device outcomes demonstrate a high technical success rate, no 30-day lesion-related mortality, and a low rate of safety events within 30 days of the index procedure.

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

OBJECTIVE: To 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). METHODS: This 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. RESULTS: During 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. CONCLUSIONS: The 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.

National registry insights on genetic aortopathies and thoracic endovascular aortic interventions.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) in patients with genetic aortopathies (GA) is controversial, given concerns of durability. We describe characteristics and outcomes after TEVAR in patients with GA. METHODS: All patients undergoing TEVAR between 2010 and 2023 in the Vascular Quality Iniatitive were identified and categorized as having a GA or not. Demographics, baseline, and procedural characteristics were compared among groups. Multivariable logistic regression was used to evaluate the independent association of GA with postoperative outcomes. Kaplan-Meier methods and multivariable Cox regression analyses were used to evaluate 5-year survival and 2-year reinterventions. RESULTS: Of 19,340 patients, 304 (1.6%) had GA (87% Marfan syndrome, 9% Loeys-Dietz syndrome, and 4% vascular Ehlers-Danlos syndrome). Compared with patients without GA, patients with GA were younger (50 years [interquartile range, 37-72 years] vs 70 years [interquartile range, 61-77 years]), more often presented with acute dissection (28% vs 18%), postdissection aneurysm (48% vs 17%), had a symptomatic presentation (50% vs 39%), and were less likely to have degenerative aneurysms (18% vs 47%) or penetrating aortic ulcer (and intramural hematoma) (3% vs 13%) (all P < .001). Patients with GA were more likely to have prior repair of the ascending aorta/arch (open, 56% vs 11% [P < .001]; endovascular, 5.6% vs 2.1% [P = .017]) or the descending thoracic aorta (open, 12% vs 2% [P = .007]; endovascular, 8.2% vs 3.6% [P = .011]). No significant differences were found in prior abdominal suprarenal repairs; however, patients with GA had more prior open infrarenal repairs (5.3% vs 3.2%), but fewer prior endovascular infrarenal repairs (3.3% vs 5.5%) (all P < .05). After adjusting for demographics, comorbidities, and disease characteristics, patients with GA had similar odds of perioperative mortality (4.6% vs 7.0%; adjusted odds ratio [aOR], 1.1; 95% confidence interval [CI], 0.57-1.9; P = .75), any in-hospital complication (26% vs 23%; aOR, 1.24; 95% CI, 0.92-1.6; P = .14), or in-hospital reintervention (13% vs 8.3%; aOR, 1.25; 95% CI, 0.84-1.80; P = .25) compared with patients without GA. However, patients with GA had a higher likelihood of postoperative vasopressors (33% vs 27%; aOR, 1.44; 95% CI, 1.1-1.9; P = .006) and transfusion (25% vs 23%; aOR, 1.39; 95% CI, 1.03-1.9; P = .006). The 2-year reintervention rates were higher in patients with GA (25% vs 13%; adjusted hazard ratio, 1.99; 95% CI, 1.4-2.9; P < .001), but 5-year survival was similar (81% vs 74%; adjusted hazard ratio, 1.02; 95% CI, 0.70-1.50; P = .1). CONCLUSIONS: TEVAR for patients with GA seemed to be safe initially, with similar odds for in-hospital complications, in-hospital reinterventions, and perioperative mortality, as well as similar hazards for 5-year mortality compared with patients without GA. However, patients with GA had higher 2-year reintervention rates. Future studies should assess long-term durability after TEVAR compared with the recommended open repair to appropriately weigh the risks and benefits of endovascular treatment in patients with GA.

A national census for the off-label treatment of complex aortic aneurysms.

OBJECTIVE: Despite regulatory challenges, device availability, and rapidly expanding techniques, off-label endovascular repair of complex aortic aneurysms (cAAs) has expanded in the past decade. Given the lack of United States Food and Drug Administration-approved endovascular technology to treat cAAs, we performed a national census to better understand volume and current practice patterns in the United States. METHODS: Targeted sampling identified vascular surgeons with experience in off-label endovascular repair of cAAs. An electronic survey was distributed with institutional review board approval from the University of Rochester to 261 individuals with a response rate of 38% (n = 98). RESULTS: A total of 93 respondents (95%) reported off-label endovascular repair of cAAs. Mean age was 45.7 ± 8.3 years, and 84% were male. Most respondents (59%) were within the first 10 years of practice, and 69% trained at institutions with a high-volume of off-label endovascular procedures for complex aortic aneurysms with or without a physician-sponsored investigational device exemption (PS-IDE). Twelve respondents from 11 institutions reported institutional PS-IDEs for physician-modified endografts (PMEGs), in-situ laser fenestration (ISLF), or parallel grafting technique (PGT), including sites with PS-IDEs for custom-manufactured devices. Eighty-nine unique institutions reported elective off-label endovascular repair with a mean of 20.2 ± 16.5 cases/year and ∼1757 total cases/year nationally. Eighty reported urgent/emergent off-label endovascular repair with a mean of 5.7 ± 5.4 cases/year and ∼499 total cases/year nationally. There was no correlation between high-volume endovascular institutions (>15 cases/year) and institutions with high volumes of open surgical repair for cAAs (>15 cases/year; odds ratio, 0.7; 95% confidence interval, 0.3-1.5; P = .34). Elective techniques included PMEG (70%), ISLF (30%), hybrid PMEG/ISLF (18%), and PGT (14%), with PMEG being the preferred technique for 63% of respondents. Techniques for emergent endovascular treatment of complex aortic disease included PMEG (52%), ISLF (40%), PGT (20%), and hybrid-PMEG/ISLF (14%), with PMEG being the preferred technique for 41% of respondents. Thirty-nine percent of respondents always or frequently offer referrals to institutions with PS-IDEs for custom-manufactured devices. The most common barrier for referral to PS-IDE centers included geographic distance (48%), longitudinal relationship with patient (45%), and costs associated with travel (33%). Only 61% of respondents participate in the Vascular Quality Initiative for complex endovascular aneurysm repair, and only 57% maintain a prospective institutional database. Eighty-six percent reported interest in a national collaborative database for off-label endovascular repair of cAA. CONCLUSIONS: Estimates of off-label endovascular repair of cAAs are likely underrepresented in the literature based on this national census. PMEG was the most common technique for elective and emergent procedures. Under-reported off-label endovascular repair of cAA outcomes data appears to be limited by non-standardized PS-IDE reporting to the United States Food and Drug Administration, and the lack of Vascular Quality Initiative participation and prospective institutional data collection. Most participants are interested in a national collaborative database for endovascular repair of cAAs.

Acute kidney injury in patients undergoing endovascular or open repair of juxtarenal or pararenal aortic aneurysms.

BACKGROUND: The aim of this cohort study was to report the proportion of patients who develop periprocedural acute kidney injury (AKI) after endovascular repair (ER) and open surgery (OS) in patients with juxta/pararenal abdominal aortic aneurysm and to assess potential risk factors for AKI. The study also aimed to report the short- and long-term outcomes of patients with and without AKI. METHODS: This was a multicenter cohort study of five European academic high-volume centers (>50 OS or 50 ER infrarenal AAA repairs, plus >15 complex AAA repairs per year). All consecutively treated patients were extracted from a prospective vascular surgical registry and the data were scrutinized retrospectively. The primary end point for this study was the development of AKI. AKI was diagnosed when there is a two-fold increase of serum creatinine or decrease of glomerular filtration rate of >50% within 1 week of AAA repair. Secondary end points included long-term mortality and end-stage renal disease (ESRD). RESULTS: AKI occurred in 16.6% of patients in the ER group vs 30.3% in the OS group (P < .001). The 30-day mortality rate was higher among patients with AKI in both ER (15.4% vs 3.1%; P = .006) and OS (13.2% vs 5.3%; P = .001) groups. Age, chronic kidney disease, presence of significant thrombus burden in the pararenal region, >1000 mL blood loss in ER group were associated with development of AKI. Age, diabetes mellitus, chronic kidney disease, presence of significant thrombus burden in the pararenal region, and a proximal clamping time of >30 minutes in the OS group were associated with the development of AKI, whereas renal perfusion during clamping was the protective factor against AKI development. After a median follow-up of 91 months, AKI was associated with higher mortality rates in both the ER group (58.9% vs 29.7%; P < .001) and the OS group (61.5% vs 27.3%; P < .001). After the same follow-up period, AKI was associated with a higher incidence of ESRD in both the ER group (12.8% vs 3.6%; P = .009) and the OS group (9.9% vs 2.9%; P < .001). CONCLUSIONS: The current study identified important pre and postoperative factors associated with AKI after juxta/pararenal abdominal aortic aneurysm repair. Patients with postoperative AKI had significantly higher short- and long term mortality and higher incidence of ESRD than patients without AKI.

Large-Diameter Fenestrated Endograft Repair of Abdominal Aortic Aneurysms Is Not Associated With Medium-Term Outcomes.

INTRODUCTION: Recent data suggests that infrarenal abdominal aortic aneurysm (AAA) endovascular repair (EVAR) with large diameter grafts (LGs) may have a higher risk of endoleak and reintervention. However, this has not been studied extensively for fenestrated endovascular aneurysm repair (fEVAR). We, therefore, sought to evaluate the outcomes of patients undergoing fEVAR with large-diameter endografts. METHODS: Patients from the national Vascular Quality Initiative registry who underwent fEVAR for intact juxtarenal AAA were identified. Patients with genetic causes for aneurysms, those with prior aortic surgery, and those undergoing repair for symptomatic or ruptured aneurysms were excluded. Rates of endoleaks and reintervention at periprocedural and long-term follow-up timepoints (9-22 mo) were analyzed in grafts 32 mm or larger (LG) and were compared to those smaller than 32 mm (small diameter graft). RESULTS: A total of 693 patients (22.8% LG) were identified. Overall, demographic variables were comparable except LG exhibited a more frequent history of coronary artery disease (32.9% versus 25.4%, P = 0.037). There were no significant differences in the rates of endoleak at procedural completion. Overall survival at 5 y was no different. The rate of reintervention at 1 y was also no different (log-rank P = 0.86). CONCLUSIONS: While graft size appears to have an association with outcomes in infrarenal aneurysm repair, the same does not appear to be true for fEVAR. Further studies should evaluate the long-term outcomes associated with LG which could alter the approach to repair of AAA with large neck diameters traditionally treated with standard infrarenal EVAR.

An Anatomic Classification Scheme for Surgical Planning of Renal Artery Aneurysms.

PURPOSE: Renal artery aneurysm (RAA) is a rare disease. This study proposed and evaluated a new classification for RAA to assist in surgical decision-making. MATERIALS AND METHODS: Single-center data of 105 patients with RAAs from the vascular department of vascular surgery were collected retrospectively. A new classification scheme was proposed. Type I aneurysms arise from the main trunk, accessory branch, or first-order branches away from any bifurcation. Type II aneurysms arise from the first bifurcation with narrow necks (defined as dome-to-neck ratio >2) or from intralobular branches. Type III aneurysms with a wide neck arise from the first bifurcation and affect 2 or more branches that cannot be sacrificed without significant infarction of the kidney. RESULTS: There was 50 (47.62%) type I, 33 (31.43%) type II, and 22 (20.95%) type III aneurysms. The classification assigned endovascular repair as first-line treatment (for type I or II), while open techniques were conducted if anatomically suitable (for type III). A kappa level of 0.752 was achieved by the classification compared with a level of 0.579 from the classic Rundback classification. Technical primary success was achieved in 100% and 96.05%, and symptoms were completely resolved in 100% and 84.85%, while hypertension was relieved in 84.21% and 72.92% of patients receiving open surgery or endovascular repair, respectively. No significant difference was observed for perioperative or long-term complications among the 3 classification types. CONCLUSION: The new classification proved to be a convenient and effective method for facilitating choice of intervention for RAAs. CLINICAL IMPACT: This study proposed and evaluated a new classification scheme for renal artery aneurysms, which proved to be a convenient and effective method for facilitating surgical decision-making. Coil embolization was the first-line treatment if suitable, while aneurysm resection and reconstruction with vein graft were conducted for some complex lesions. The safety and efficacy of both open and endovascular methods were validated.

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

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

Systematic Review and Meta-analysis of Fenestrated and Chimney/Snorkel Techniques for Endovascular Repair of Juxtarenal Aortic Aneurysms.

OBJECTIVES: Comparative effectiveness of fenestrated endovascular aneurysm repair (FEVAR) and chimney graft endovascular aneurysm repair (ChEVAR) for juxtarenal aortic aneurysms (JAAs) remains unclear. Our objective was to identify and analyze the current body of evidence comparing the effectiveness of both techniques for JAA. METHODS: We performed a systematic review and meta-analysis comparing the effectiveness of FEVAR and ChEVAR for JAA repair. We searched MEDLINE, EMBASE, and Cochrane Register for Controlled Trials from January 1, 1990, for randomized and non-randomized studies assessing outcomes of FEVAR and ChEVAR for JAA repair. Screening, data extraction, risk of bias assessment, and GRADE (Grading of Recommendations, Assessments, Development, and Evaluations) certainty of evidence were performed in duplicate. Data were pooled statistically where possible. RESULTS: Nine retrospective cohort studies comparing the use of FEVAR and ChEVAR for juxtarenal aneurysm were included for meta-analysis. The FEVAR and ChEVAR arms of the meta-analysis consisted of 726 participants and 518 participants, respectively. There were 598 (86.8%) and 332 (81.6%) men in each arm. The mean diameter was larger in the ChEVAR arm (59 mm vs 52.5 mm). Both techniques had similar rates of postoperative 30-day mortality, 3.38% (8/237) versus 3.52% (8/227), acute kidney injury, 16.76% (31/185) versus 17.31% (18/104), and major adverse cardiac events, 7.30% (46/630) versus 6.60% (22/333). The meta-analysis supported the use of FEVAR for most outcomes, with significant advantage for technical success (odds ratio [OR]: 3.24, 95% CI: 1.24-8.42) and avoidance of type 1 endoleak (OR: 5.76, 95% CI: 1.94-17.08), but a disadvantage for spinal cord ischemia (OR: 10.21, 95% CI: 1.21-86.11), which had a very low number of events. The quality of evidence was "moderate" for most outcomes. CONCLUSION: Both endovascular techniques had good safety profiles. The evidence does not support superiority of either FEVAR or ChEVAR for JAA. CLINICAL IMPACT: While lack of equipoise has hampered the design of randomised trials of open versus endovascular repair of juxtarenal aortic aneurysms, concern about the durability of endovascular repair highlights the need for stronger evidence of the comparative efficacy of endovascular techniques. This review performed meta-analysis and evidence appraisal of recent data from large observational studies comparing fenestrated and chimney techniques, using a comprehensive outcome set. Superiority of either intervention could not be established due to differences in participants' baseline risk in each study arm. However, data suggests that both techniques are safe and suitable for use when indicated.

A Systematic Review on Thoracic Endovascular Repair Outcomes in Blunt Thoracic Aortic Injuries.

PURPOSE: Blunt thoracic aortic injury (BTAI) represents a potentially life-threatening condition and thoracic endovascular aortic repair (TEVAR) is recommended as the first-line treatment (Class I level of evidence C) by the current guidelines. The aim of this systematic review was to determine the perioperative and mid-term follow-up outcomes of patients with BTAI treated with TEVAR. MATERIALS AND METHODS: We reviewed the English literature published between 2000 and 2022, via Ovid, using MEDLINE, EMBASE, and CENTRAL databases, until July 30, 2022. Observational studies and case series, with ≥5 patients, reporting on the perioperative and follow-up outcomes of patients who underwent TEVAR for BTAI were included. The Newcastle-Ottawa Scale was used to assess the risk of bias. Primary outcomes were technical success and 30-day mortality, cerebrovascular morbidity. Secondary outcomes were mortality and re-interventions during the mid-term follow-up. RESULTS: From 5201 articles identified by the literature search, 35 eligible studies were included in this review. All studies had a retrospective study design. In total, 991 patients were included. The mean age was 34.5±16.5 years (range=16-89 years). Technical success was 98.0% (odds ratio [OR], 95% confidence interval [CI]=0.98, 0.99, p<0.001, I2=0%). Mortality at 30 days was 5.0% (OR, 95% CI=0.03, 0.06, p<0.001, I2=5.56%). Spinal cord ischemia occurred in 1.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%) and stroke rate was 2.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%). The available follow-up was estimated at 29 months (range=3-119 months) with mortality rate at 2.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%) and re-intervention rate at 1.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=10.5%). CONCLUSION: Thoracic endovascular aortic repair showed high technical success and low early cerebrovascular morbidity and mortality rates. In the mid-term follow-up, the estimated mortality and re-intervention rates were also low. Furthermore, higher quality prospective studies are needed. CLINICAL IMPACT: Thoracic endovascular aortic repair (TEVAR) is recommended as the first line treatement in patients with blunt thoracic aortic injuries (BTAI). This systematic review of 35 retrospective studies and 991 patients showed high technical success (98.0%) with an associated 30-day mortality at 5.0% and low spinal cord ischemia (1%) and stroke rates (2.0%). Mid-term mortality and re-intervention rates reassure the effectiveness of TEVAR in BTAI cases.

The Initial Results of Physician-Modified Fenestrated-Branched Endovascular Repairs of the Aortic Arch and Lessons Learned From the First 21 Cases.

INTRODUCTION: Physician-modified fenestrated-branched endovascular aortic repair (PM-FBEVAR) for the aortic arch provides a minimally invasive treatment option for patients who are too high-risk for open repair. Improvements in technique are gained with ongoing experience with these complex repairs. This study aims to describe outcomes of arch PM-FBEVAR and technical lessons. MATERIALS AND METHODS: A retrospective review of consecutive patients who underwent PM-FBEVAR with zone 0 proximal sealing at a single institution between January 2019 and July 2023 was performed. Cases completed using initial techniques (early technique) were compared with cases using the current techniques (current technique). Modification technique changed to include a self-orienting spine trigger wire and anatomically specific fenestrations or inner branches in the current group. The primary outcome was in-hospital mortality. Secondary outcomes included technical success and 30 day stroke. RESULTS: A total of 21 patients underwent arch PM-FBEVAR, with 7 in the early group and 14 in the current group. Severe comorbidities were present in both groups including chronic obstructive pulmonary disease (COPD) (43% vs 36%), prior open ascending aortic repair (57% vs 43%), and prior stroke (86% vs 21%), respectively. Technical success was the same (86% vs 86%, p=1.0). Fluoroscopy time (56 vs 24 min, p=0.012) and in-hospital death (43% vs 0%, p=0.026) were significantly lower in the current group. A 30 day stroke rate (29% vs 7%, p=0.247) was non-significantly decreased in the current group. All-cause mortality was 100% vs 7% during median follow-up of 8 and 6 months (p<0.001). Three deaths in the early group were related to their aortic arch repair including aortic rupture during endograft advancement and 2 postoperative strokes. CONCLUSION: There is a significant learning curve associated with aortic arch PM-FBEVAR. This study suggests that gained experience, use of the spine trigger wire technique, and precise creation of fenestrations or inner branches can lead to a shorter procedure time and lower complications. CLINICAL IMPACT: Physician modified fenestrated branched endografting is feasible for the aortic arch. The high rate of stroke and perioperative mortality was reduced with incorporation of self-orienting spine trigger wire and anatomically specific inner branch creation.

The Complementary Roles of Open and Endovascular Repair of Extent I - III Thoraco-abdominal Aortic Aneurysms in a United Kingdom Aortic Centre.

OBJECTIVE: A multidisciplinary approach offering both open surgical repair (OSR) and complex endovascular aortic repair (cEVAR) is essential if patients with thoraco-abdominal aortic aneurysms (TAAAs) are to receive optimal care. This study reports early and midterm outcomes of elective and non-elective OSR and cEVAR for extent I - III TAAA in a UK aortic centre. METHODS: Retrospective study of consecutive patients treated between January 2009 and December 2021. Primary endpoint was 30 day/in hospital mortality. Secondary endpoint was Kaplan-Meier estimates of midterm survival. Data are presented as median (interquartile range [IQR]). RESULTS: In total, 296 patients (176 men; median age 71 years [IQR 65, 76]; median aneurysm diameter 66 mm [IQR 61, 75]) underwent repair (222 elective, 74 non-elective). OSR patients (n = 66) were significantly younger with a higher incidence of heritable disease and chronic dissection, while cEVAR patients (n = 230) had a significantly higher prevalence of coronary, pulmonary, and renal disease. Overall, in hospital mortality after elective and non-elective repair was 3.2% (n = 7) and 23.0% (n = 17), respectively, with no significant difference between treatment modalities (elective OSR 6.5% vs. cEVAR 2.3%, p = .14; non-elective OSR 25.0% vs. cEVAR 20.3%, p = .80). Major non-fatal complications occurred in 15.3% (33/215) after elective repair (OSR 39.5%, 17/43, vs. cEVAR 9.3%, 16/172; p < .001) and 14% (8/57) after non-elective repair (OSR 26.7%, 4/15, vs. cEVAR 9.5%, 4/42; p = .19). Median follow up was 52 months (IQR 23, 78). Estimated survival ± standard error at 1, 3, and 5 years for the entire cohort was 89.6 ± 2.0%, 76.6 ± 2.9%, and 69.0% ± 3.2% after elective repair, and 67.6 ± 5.4%, 52.1 ± 6.0%, and 41.0 ± 6.2% after non-elective repair. There was no difference in 5 year survival comparing modalities after elective repair for patients younger than 70 years and those with post-dissection aneurysms. CONCLUSION: A multidisciplinary approach offering OSR and cEVAR can deliver comprehensive care for extent I - III TAAA with low early mortality and good midterm survival. Further studies are required to determine the optimal complementary roles of each treatment modality.