Multicenter Study on Physician-Modified Endografts for Thoracoabdominal and Complex Abdominal Aortic Aneurysm Repair.

BACKGROUND: Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal aortic aneurysm, however, previous data are limited to small single center studies and robust data on safety and effectiveness of PMEGs are lacking. We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. METHODS: An international multicenter single-arm cohort study was performed analyzing the outcomes of PMEGs in the treatment of elective, symptomatic, and ruptured complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. Variables and outcomes were defined according to the Society for Vascular Surgery reporting standards. Device modification and procedure details were collected and analyzed. Efficacy outcomes included technical success and safety outcomes included major adverse events and 30-day mortality. Follow-up outcomes included reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. Multivariable analysis was performed aiming at identifying predictors of technical success, 30-day mortality, and major adverse events. RESULTS: Overall, 1274 patients were included in the study from 19 centers. Median age was 74 (IQR, 68-79), and 75.7% were men; 45.7% were complex abdominal aortic aneurysms, and 54.3% were thoracoabdominal aortic aneurysms; 65.5% patients presented electively, 24.6% were symptomatic, and 9.9% were ruptured. Most patients (83.1%) were submitted to a fenestrated repair, 3.6% to branched repair, and 13.4% to a combined fenestrated and branched repair. Most patients (85.8%) had ≥3 target vessels included. The overall technical success was 94% (94% in elective, 93.4% in symptomatic, and 95.1% in ruptured cases). Thirty-day mortality was 5.8% (4.1% in elective, 7.6% in symptomatic, and 12.7% in ruptured aneurysms). Major adverse events occurred in 25.2% of cases (23.1% in elective, 27.8% in symptomatic, and 30.3% in ruptured aneurysms). Median follow-up was 21 months (5.6-50.6). Freedom from reintervention was 73.8%, 61.8%, and 51.4% at 1, 3, and 5 years; primary target vessel patency was 96.9%, 93.6%, and 90.3%. Overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6%, and 55.0%/89.1% at 1, 3, and 5 years. CONCLUSIONS: PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data and future prospective studies are needed for more robust and detailed analysis.

A Retrospective Analysis of 10-year Experience on Branched and Fenestrated Endovascular Aortic Arch Repair.

OBJECTIVE: This study aimed to present the early and mid-term outcomes of fenestrated/branched thoracic endovascular aortic repair (f/bTEVAR) for aortic arch pathologies. BACKGROUND: f/bTEVAR represents a less invasive treatment option for aortic arch diseases. Previous published series showed decreased early mortality and morbidity compared to open repair. METHODS: A single-center retrospective analysis of consecutive patients, managed with f/bTEVAR (Cook Medical, Bloomington, IN, USA) between 01.09.11and 30.06.22 was conducted. Primary outcomes were technical success, 30-day mortality and stroke. Data during follow-up and factors affecting early mortality and stroke were analyzed. RESULTS: 209 patients were included (38.3% females; mean age 69.8±3.4years; mean aortic diameter 61±4.7 mm); 14.4% were managed urgently. Fenestrations/scallop configuration was used in 39.7%, branched devices in 55.5% and branch/scallop combination in 4.8%. Landing to zone 0 was performed in 65.5% and in zone 1 in 32.1%. Non-native aortas were used for landing in 39.2%. Technical success was 97.1% and 30-day mortality 9.5%. Strokes were identified in 10%; 5.7% major. Non-native proximal aortic landing zone was an independent protective factor for stroke (P=0.002). Post-operative stroke (P<0.001) and pericardial effusion (P<0.001) were independently related to 30-day mortality. The mean follow-up was 21±8 months. The estimated survival and freedom from reintervention rates were 79.5% (standard error; SE3.1%) and 47.1% (SE 4.3%) at 24months, respectively. CONCLUSIONS: f/bTEVAR presented high technical success and acceptable 30-day mortality. Non-native proximal landing zone was related to lower stroke rate. Half of patients needed a reintervention within the 24-month follow-up.

Endovascular Repair of One-hundred Urgent and Emergent free or Contained Thoraco-abdominal Aortic Aneurysms Ruptures. An International Multi-Center Trans-Atlantic experience.

OBJECTIVE: To analyze the outcomes of urgent/emergent endovascular aortic repair of patients with free/contained ruptured thoracoabdominal aortic aneurysms (rTAAA). BACKGROUND: Endovascular repair of rTAAA has been scarcely described in emergent setting. METHODS: An international multicenter retrospective observational study (ClinicalTrials.govID:NCT05956873) from January-2015 to January-2023 in 6 European and 1 United States Vascular Surgery Centers. Primary end-points were technical success, 30-day and/or in-hospital mortality and follow-up survival. RESULTS: A total of 100 rTAAA patients were included (75 male; mean age 73 y). All patients (86 contained and 14 free ruptures) were symptomatic and treated within 24-hours from diagnosis: multi-branched off-the-shelf devices (Zenith t-branch,Cook Medical Inc.Bjaeverskov,Denmark) in 88 patients, physician-modified endografts in 8, patient-specific device or parallel grafts in two patients each. Primary technical success was achieved in 89 patients and 30-day and/or in-hospital mortality was 24%. Major adverse events (MAEs) occurred in 34% of patients (permanent dialysis and paraplegia in 4 and 8 patients, respectively). No statistical differences were detected in mortality rates between free and contained ruptured patients (43%vs.21%; P =0.075). Multivariate analysis revealed contained rupture favoring technical success (Odd-Ratio10.1;95%Confidence-Interval:3.0-33.6; P =<0.001). MAEs (OR9.4;95%C-I:2.8-30.5; P =<0.001) and pulmonary complications (OR11.3;95%CI:3.0-41.5; P =<0.001) were independent risk factors for 30-day and/or in-hospital mortality. Median follow-up time was 13 months (interquartile range 5-24); 1-year survival rate was 65%. Aneurysm diameter>80 mm (Hazard-Ratio:2.0;95%CI:1.0-30.5; P =0.037), technical failure (HR:2.6;95%CI:1.1-6.5; P =0.045) and pulmonary complications (HR:3.0;95%CI:1.2-7.9; P =0.021) were independent risk factors for follow-up mortality. CONCLUSION: Endovascular repair of rTAAA shows high technical success; the presence of free rupture alone appear not to correlate with early mortality. Effective prevention/management of post-operative complications is crucial for survival.

Systematic review and meta-analysis of fenestrated or branched devices after previous open surgical aortic aneurysm repair.

OBJECTIVE: Despite open surgical repair (OSR) of abdominal aortic aneurysms being considered as a durable solution, disease progression and para-anastomotic aneurysms may require further repair, and fenestrated and branched endovascular aneurysm repair (F/BEVAR) may be applied to address these pathologies. The aim of this systematic review was to assess technical success, mortality, and morbidity (acute kidney injury, spinal cord ischemia) at 30 days, and mortality and reintervention rates during the available follow-up, in patients managed with F/BEVAR after previous OSR. METHODS: The PRISMA statement was followed, and the study was pre-registered to the PROSPERO (CRD42022363214). The English literature was searched, via Ovid, using MEDLINE, EMBASE, and CENTRAL databases, through November 30, 2022. Observational studies and case series with ≥5 patients (2000-2022), reporting on F/BEVAR outcomes after OSR, were considered eligible. The Newcastle-Ottawa Scale and GRADE were used to assess the risk of bias and quality of evidence. The primary outcome was technical success, mortality, and morbidity at 30 days. Data on the outcomes of interest were synthesized using proportional meta-analysis. RESULTS: The initial search yielded 1694 articles. Eight retrospective studies (476 patients) were considered eligible. In 78.3% of cases, disease progression set the indication for reintervention. Technical success was estimated at 96% (95% confidence interval [CI], 89%-98%; I2 = 0%; 95% prediction interval [PI], 79%-99%). Thirty-day mortality was 2% (95% CI, 1%-9%; I2 = 0%; 95% PI, 0%-28%). The estimated spinal cord ischemia and acute kidney injury rates were 3% (95% CI, 1%-9%; I2 = 0%; 95% PI, 0%-30%) and 6% (95% CI, 2%-15%; I2 = 0%; 95% PI, 1%-40%), respectively. During follow-up, overall mortality was 5% (95% CI, 2%-12%; I2 = 34%; 95% PI, 0%-45%) and aorta-related mortality was 1% (95% CI, 0%-2%; I2 = 0%; 95% PI, 0%-3%). The rate of reinterventions was 16% (95% CI, 9%-26%; I2 = 22%; 95% PI, 3%-50%). CONCLUSIONS: According to the available literature, F/BEVAR after OSR may be performed with high technical success and low mortality and morbidity during the perioperative period. Follow-up aortic-related mortality was 1%, whereas the reintervention rates were within the standard range following F/BEVAR.

Early and midterm outcomes of fenestrated and branched endovascular aortic repair in thoracoabdominal aneurysms types I through III.

BACKGROUND: Fenestrated and branched endovascular aortic repair (F/BEVAR) of thoracoabdominal aortic aneurysms (TAAAs) has shown high technical success and low early mortality rates. Aneurysm extent has been reported as a factor affecting outcomes. This study aimed to assess the early and midterm follow-up outcomes of patients managed by F/BEVAR for types I through III TAAAs. METHODS: A single-center retrospective analysis was conducted, including data from consecutive, elective and urgent (symptomatic and ruptured cases), patients treated for types I through III TAAAs, between October 1, 2011, and October 1, 2022, using F/BEVAR. Degenerative and postdissection TAAAs were included. Patients received prophylactic cerebrospinal fluid drainage (CSFD), except those under therapeutic anticoagulation, those who were hemodynamically unstable, or those with failed CSFD application. When an initial thoracic endovascular aortic repair was performed, as part of a staged procedure, no CSFD was used. Later stages and nonstaged procedures were performed under CSFD. Thirty-day mortality and major adverse events (MAEs) were analyzed. Kaplan-Meier estimates were used for follow-up outcomes. RESULTS: F/BEVAR for types I through III TAAAs was performed in 209 patients (56.9% males; mean age, 69.6 ± 3.2 years; mean aneurysm diameter, 65.2 ± 6.2 mm); 29.2% type I, 57.9% type II, and 12.9% type III. Urgent repair was performed in 26.7% of patients (56 cases; 23 ruptured and 33 symptomatic cases) and 153 were treated electively. Thirty-two patients (15.3%) were classified as American Society of Anesthesiologists (ASA) class IV. CSFD was used in 91% and staged thoracic endovascular aortic repair was performed in 51.2% of patients. Technical success was 93.8% (96.7% in elective vs 94.6% in urgent cases; P = .92). Thirty-day mortality was 11.0% (4.6% in elective vs 28.5% in urgent cases; P < .001) and MAEs were recorded in 17.2% of cases (7.8% in elective vs 42.8% in urgent cases; P < .001). Spinal cord ischemia rate was 20.5% (17.6% in elective vs 28.7% in urgent cases; P = .08), whereas 2.9% of patients presented paraplegia (1.3% in elective and 7.1% in urgent cases; P = .03). The mean follow-up was 16 ± 5 months. Survival was 75.0% (standard error, 4.0%) and freedom from reintervention was 73.3% (standard error, 4.4%) at 36 months. ASA IV and urgent repair were detected as independent factors related to early mortality and MAE, whereas ruptured aneurysm status was related to spinal cord ischemia evolution. CONCLUSIONS: Endovascular repair for types I through III TAAAs provides encouraging early outcomes in terms of mortality, MAE, and paraplegia, especially in an elective setting. Setting of repair and baseline ASA score should be taken into consideration during decision-making.

Midterm single center results with the use of custom-made endografts with inner branches, a call for attention.

OBJECTIVE: To evaluate the patency of bridging covered stents (BCS) bridged to inner branches in custom-made thoracoabdominal endografts. METHODS: Single-center retrospective study identifying all patients undergoing fenestrated or branched endovascular aortic repair (f/b EVAR) in whom the reno-visceral target vessels (TV) were bridged with a BCS to an inner branch of a custom made (CMD) endograft.. Technical success and perioperative complications were noted. Follow-up BCS patency were evaluated and in patients with follow-up, two groups based on BCS were created, a group with BCS occlusion and a group with BCS patent. Uni und multivariable analysis were performed to analyze factors related to visceral and renal bridging stent occlusion. RESULTS: From 2019-2022, 69 patients undergoing complex aortic repair had at least one TV bridged to an inner branch built into a CMD endograft. 86% of the grafts had only inner branches, whereas 14% had a mix of fenestrations for the visceral TV and inner branches for the renal arteries. Twenty-five percent of patients presented as urgency and received an endograft originally designed for another patient and available on our shelf at the time. 245 TVs were connected to inner branches: celiac trunk (CT): 54, superior mesenteric artery (SMA): 59, renal artery (RA): 132. Technical success was 99%. There was a 23% complication and 9% perioperative mortality rate. At follow-up, we identified 6% of visceral and 14% of renal BCS occlusions. The primary patency for RA BCS was 83% at 12 months and 58% at 24 months. For the CT-SMA BCS, Kaplan-Maier (KM) showed a patency of 99% and 96% at 12 and 24 months. In the univariate analysis a misaligned TV ostium (p 0.001), the postoperative BCS diameter on postoperative CTA (p 0.02) and the preoperative infrarenal aortic angle >60º (0.007) were correlated with RA BCS occlusion. In the multivariate analysis only the misaligned TV ostium (p 0.002) and infrarenal angle > 60° (p 0.01) were significantly correlated. CONCLUSIONS: In our series of complex aortic repair, the incorporation of inner branches to bridge TVs is associated with a high renal BCS occlusion rate. Improper alignment of the branches with the TV ostium and acute aortic angles might play a significant role. Further research on this technology is needed.

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

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

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.

Urgent endovascular repair of juxtarenal/pararenal aneurysm by off-the-shelf multibranched endograft.

OBJECTIVE: To report outcomes of urgent juxtarenal/pararenal aneurysms (J/P-AAAs) managed by off-the-shelf multibranched thoracoabdominal endografts (Cook, T-branch). METHODS: In this observational, multicenter, retrospective study, patients with J/P-AAAs treated by urgent endovascular repair by T-branch in 23 European aortic centers, from 2013 to 2023, were analyzed. Contained J/P-AAAs rupture, presence of related symptoms, and aneurysm diameter of >70 mm were considered as indication for urgent repair. Technical success (TS), spinal cord ischemia (SCI), and 30-day/hospital mortality were assessed as early outcomes. Survival, freedom from reinterventions, and target artery instability (TAI) were evaluated during follow-up. RESULTS: Overall, 197 patients (J-AAAs, n = 64 [33%]; P-AAAs, n = 95 [48%]; previous failed endovascular aneurysm repair (EVAR), n = 38 [19%]) were analyzed. The mean age and aneurysm diameter was 75 ± 8 years and 76 ± 4 mm, respectively. The American Society of Anesthesiologists score was 3 and 4 in 118 (60%) and 79 (40%) patients. Rupture, symptoms, and diameter of >70 mm were present in 51 (26%), 110 (56%), and 53 (27%) patients, respectively. An adjunctive proximal thoracic endograft was used in 28 cases (14%). The mean aortic coverage between the upper portion of the endograft and the lowest renal artery was 154 ± 49 mm. Single-stage repair and cerebrospinal fluid drainage were reported in 144 (73%) and 53 (27%) cases, respectively. TS was achieved in 182 (92%) cases (rupture, 84% vs no rupture, 95%; P = .02). Failures consist of TA loss (11 [6%]: renal artery, 9; celiac trunk, 2), type I to III endoleaks (2 [1%]), and 24-h mortality (2 [1%]). Rupture was a risk factor for technical failure (P = .02; odds ratio [OR], 3.8; 95% confidence interval [CI], 1.1-12.1). Overall, 15 patients (8%) had persistent SCI (rupture, 14% vs no rupture, 5%) with 11 (6%) , of paraplegia (rupture, 10% vs no rupture, 5%; P = .001). Rupture (P = .04; OR, 3.1; 95% CI, 1.1-8.9) and adjunctive proximal thoracic endograft (P = .01; OR, 4.1; 95% CI, 1.3-12.9) were risk-factors for SCI. Twenty-two patients (11%) died within 30 days or during a prolonged hospitalization. Previous failed EVAR (P = .04; OR, 3.6; 95% CI, 1.1-12.3), paraplegia (P < .001; OR, 9.9; 95% CI, 1.6-62.2) and postoperative mesenteric complications (P = .03; OR, 10.4; 95% CI, 1.2-93.3), as well as cardiac (P = .03; OR, 8.2; 95% CI, 2.0-33.0) and respiratory (P < .001; OR, 10.1; 95% CI, 2.9-35.2) morbidities were associated with 30-day/hospital mortality. The mean follow-up was 19 ± 5 months. The estimated 3-year survival and freedom from reinterventions was 58% and 77%, respectively. TAI occurred in 27 patients (14%) (occlusion, 15; endoleak, 14) with an estimated 3-year freedom from TAI of 72%. CONCLUSIONS: Urgent repair of J/P-AAAs by T-branch is feasible and effective with satisfactory TS and 30-day/hospital mortality in high-risk patients. However, extensive aortic coverage is necessary, leading to a non-negligible SCI rate, especially in case of aortic rupture or when adjunctive thoracic endografts are necessary. Previous failed EVAR and postoperative mesenteric complications, as well as cardiac and respiratory morbidities were associated with 30-day/hospital mortality and should be subjected to more research for the purposes of improving outcomes.

An international, expert-based, Delphi consensus document on controversial issues in the management of abdominal aortic aneurysms.

OBJECTIVE: As a result of conflicting, inadequate or controversial data in the literature, several issues concerning the management of patients with abdominal aortic aneurysms (AAAs) remain unanswered. The aim of this international, expert-based Delphi consensus document was to provide some guidance for clinicians on these controversial topics. METHODS: A three-round Delphi consensus document was produced with 44 experts on 6 prespecified topics regarding the management of AAAs. All answers were provided anonymously. The response rate for each round was 100%. RESULTS: Most participants (42 of 44 [95.4%]) agreed that a minimum case volume per year is essential (or probably essential) for a center to offer open or endovascular AAA repair (EVAR). Furthermore, 33 of 44 (75.0%) believed that AAA screening programs are (probably) still clinically effective and cost effective. Additionally, most panelists (36 of 44 [81.9%]) voted that surveillance after EVAR should be (or should probably be) lifelong. Finally, 35 of 44 participants (79.7%) thought that women smokers should (or should probably/possibly) be considered for screening at 65 years of age, similar to men. No consensus was achieved regarding lowering the threshold for AAA repair and the need for deep venous thrombosis prophylaxis in patients undergoing EVAR. CONCLUSIONS: This expert-based Delphi consensus document provides guidance for clinicians regarding specific unresolved issues. Consensus could not be achieved on some topics, highlighting the need for further research in those areas.

Target Vessel-Related Outcomes in Patients Managed With Branch Thoracic Aortic Endovascular Repair.

INTRODUCTION: Data on target vessel (TV)-related outcomes in patients managed with branched thoracic endovascular aortic repair (BTEVAR) are limited. This study aimed to present the TV-related outcomes of BTEVAR in patients managed for aortic arch pathologies at 30 days and during follow-up. METHODS: A retrospective analysis of consecutive patients, managed between September 1, 2011, and June 30, 2022, with custom-made aortic arch endografts (Cook Medical, Bloomington, IN, USA), presenting at least one branch configuration, were eligible. Primary outcomes were technical success, TV-related patency, and reinterventions at 30 days. RESULTS: In total, 255 TVs were revascularized using branches: 107 innominate arteries (IAs), 108 left common carotid arteries (LCCAs), and 40 left subclavian arteries (LSAs). Covered stents were used as bridging stents of which 10.2% were balloon expandable. Relining, using bare-metal stents (BMS), was performed in 14.0% of IAs, 35.2% of LCCAs, and 22.5% of LSAs. Technical success on case basis was 99.2%; no failure was related to unsuccessful TV bridging. At 30 day follow-up, no TV occlusion was detected. In 5.6% of cases, a type Ic or III endoleak, attributed to TVs, was recorded. Two patients needed early branch-related reintervention. The mean follow-up was 18.3±9.2 months. Freedom from TV instability was 94.6% (standard error [SE] 2.5%] at 12 months. No TV stenosis or occlusion was detected up to 48 months of follow-up. Freedom from TV-related reinterventions was 95.4% [SE 2.4%] at 12 months. CONCLUSION: TV stenosis or occlusion in BTEVAR cases is rare and TV-related reinterventions and instability events are mainly attributed to type Ic and III endoleak formation. CLINICAL IMPACT: Previous studies focusing on target vessel (TV) outcomes after endovascular aortic arch repair are limited. In this study, including 255 TVs revascularized using branched arch devices, bridging was performed with covered stents, of which 90% were self-expanding. Relining was at the discretion of the operator and was 14% for the innominate, 35.2% for the left common carotid and 22.5% for the left subclavian artery branches. No 30-day occlusion was detected. The freedom from TV instability was almost 95% at 12 months. TV instability and reintervention were mainly attributed to endoleaks type Ic and IIIc.

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

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

Single Access and X-Over Reversed Iliac Extension Technique in a PAD Patient Needing Complex Endovascular Aortic Aneurysm Repair.

PURPOSE: To describe the X-over reversed iliac extension technique in a patient with severe peripheral arterial disease (PAD) scheduled for inner branched endovascular aortic repair (iBEVAR). TECHNIQUE: A multimorbid 62-year-old male patient was planned for iBEVAR due to a 58 mm suprarenal aortic aneurysm. The patient had a previous right femoropopliteal bypass and stenting of the left iliac axis. At admission, he presented with recent onset severe left limb claudication, which was attributed to left iliac stent occlusion. To avoid the postoperative compression of the right common femoral artery (CFA) and preserve the patency of the bypass, a single left CFA access, followed by left iliac artery recanalization, was decided. The right iliac axis was catheterized with a Lunderquist wire using X-over access from the left CFA. An iliac extension (ZISL, 24-59, Cook Medical, Bloomington, USA) was reversed and resheathed on back-table and implanted in the right common iliac artery using the X-over technique. The left CFA access was used to complete the remaining steps of the procedure. The predischarge computed tomography angiography confirmed bilateral iliac artery and femoropopliteal bypass patency. CONCLUSION: The X-over reversed iliac extension technique may be applied in selected PAD patients, when undergoing complex endovascular aortic repair. CLINICAL IMPACT: As the number of patients with peripheral arterial disease (PAD) is expected to increase the upcoming decades, out of the box solutions may be needed to assist complex endovascular aortic management. The X over technique, which consist of the contralateral advancement of an on-table reversed iliac limb, was successfully applied in a patient with severe PAD and numerous previous peripheral interventions, who was managed with branched endovascular aortic repair . The X Over technique may provide an additional alternative in well-selected patients with demanding vascular access undergoing complex endovascular aortic procedures.

Factors Affecting Compression of the Left Subclavian Artery Bridging Stent In Zone 2 Fenestrated Endovascular Arch Repair.

INTRODUCTION: Left subclavian artery (LSA) preservation during thoracic endovascular aortic repair (TEVAR) has been related to low morbidity. This study investigated the incidence of LSA stent compression in patients managed with fenestrated endovascular arch repair (f-Arch) and evaluated the impact of anatomic and technical factors on LSA stent outcomes. METHODS: A single-center retrospective analysis of patients managed with single-fenestration devices (Cook Medical, Bloomington, IN, USA) for LSA preservation, between January 1, 2012 and November 30, 2023, was conducted. Anatomic (arch type, bovine arch, distance between the LSA and most proximal bone structure, left common carotid artery and aortic lesion, take-off angle, diameter, thrombus, calcification, dissection, tortuosity) and technical parameters (stent type, diameter, length, relining, post-dilation) were evaluated. Stent compression was any ≥50% stenosis (using center luminal line) of the stent compared with its initial diameter. Clinical outcomes included stroke and upper limb ischemia at 30 days and follow-up. Technical outcomes included stent compression and need for reintervention. RESULTS: Fifty-four cases were included. Only balloon-expandable covered stents were used, and relining during the index procedure was performed in 18%. No stroke or arm ischemia was recorded. One stent compression was detected at 30 days. During follow-up, no stroke or arm ischemia was diagnosed. Nine cases (18%) presented stent compression, with a mean time of stent-compression diagnosis at 18 months (interquartile range [IQR]=37, range=1-58 months) after the index procedure. Five (56%) underwent secondary relining. Follow-up after reintervention was uneventful. Lower distance to the nearest bone structure (compression group [CG]: 11.7±8.9 mm vs non-compression group [NCG]: 23.0±7.8 mm, p=0.003) and higher tortuosity index (CG: 1.3±0.4 vs NCG: 1.2±0.1, p=0.03) were associated with LSA stent compression. CONCLUSION: LSA stent compression in patients managed with f-Arch affected 1 in 5 cases, without clinical consequences. Distance to the nearest bone structure and higher tortuosity were associated with LSA stent compression. CLINICAL IMPACT: Fenestrated endovascular arch repair for the preservation of the left subclavian artery (LSA) in patients needing landing within the aortic arch has been performed with encouraging outcomes. This analysis showed that LSA stent compression is met in 18% of patients, without though any clinical consequence. Pre-operative anatomic parameters, as lower distance to the nearest bone structure and higher tortuosity index affect negatively LSA stent performance while stent parameters seem to have no impact.

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.

Unintended Exchange of Target Vessels for Celiac Trunk and Superior Mesenteric Artery Branches in Complex Endovascular Aortic Repair.

PURPOSE: The treatment of thoracoabdominal aortic aneurysms (TAAAs) using branched endovascular aortic repair (BEVAR) is safe and effective. During deployment, the superior mesenteric artery (SMA) branch can unintentionally open into the celiac trunk (CT) ostium and switched catheterization of the SMA from the CT branch and the CT from the SMA branch can be used as an alternative technique in these cases. This study aimed to investigate the outcome of exchanging the intended target vessels (TVs) for the CT and SMA branches during BEVAR. MATERIALS AND METHODS: A single-center retrospective analysis of patients with TAAAs who underwent BEVAR, using off-the-shelf or custom-made devices (CMDs), with an unintended exchange of TVs for the CT and SMA branches was performed. RESULTS: Between 2014 and 2023, 397 patients were treated with BEVAR for TAAA. Eighteen (4.5%) of those patients were treated with an exchange of TVs for the CT and SMA branches. T-branch was used in 9 cases (50%) and the remaining patients were treated with CMDs. Twelve patients were treated electively, 3 were symptomatic and 3 presented with rupture. Of 36 mesenteric TVs in those 18 patients, 34 (94%) were catheterized successfully, including all 18 SMAs and 16 of the 18 CTs. No branch stenosis or occlusion of the switched mesenteric TVs was detected during follow-up. During 30-day follow-up, 3 patients died and during a median follow-up of 3 (interquartile range [IQR]: 1-15) months 3 more patients died. None of the deaths or the 2 unintended reinterventions was induced by the mesenteric TV exchange. The median hospital stay was 14 (IQR: 9-22) days with a median of 4 (IQR: 2-11) days at the intensive care unit. CONCLUSION: The exchange of the mesenteric TVs for the CT and SMA branches during BEVAR with off-the-shelf and CMD endografts is feasible with good TV patency and freedom from TV-related reinterventions. This alternative technique should be considered in selected cases when direct catheterization via the intended branch is deemed more time-consuming or not feasible. CLINICAL IMPACT: This is the first description of using an exchange of target vessels for the celiac trunk and the superior mesenteric artery branches in patients with thoracoabdominal aortic aneurysms undergoing BEVAR, using off-the-shelf or custom-made devices. The high success rate as well as the good clinical results without any branch stenosis or occlusion during follow-up highlight the feasibility of this alternative technique. It could help in challenging cases when catheterization of the intended target vessels is not possible or too time consuming, resulting in higher success rates of BEVAR and better clinical results.

The Electrified Wire Technique in Complex Aortic Interventions: A Case Series.

OBJECTIVES: Electrosurgery has been long used in endovascular procedures, with only case reports in the aortic field. Our aim is to present a case series with the use of an electrified wire to perform catheter-based electrosurgery by applying external current through an electrocautery pen. METHODS: Single-center retrospective case series of all patients undergoing complex aortic surgery from October 2020 to August 2023, in whom the electrified wire technique was used: (1) Perforation of a dissection flap or left subclavian artery (LSA) in situ endograft fenestration-a 0.014" polytetrafluoroethylene (PTFE) insulated guidewire is detached from the insulation with a scalpel at the end and a cautery pen is here attached with a clamp. A curved tip catheter or sheath is positioned against the aortic flap or the endograft (through a left brachial access in this case) and the wire pushed, crossing the flap by activating the electrocautery pen and (2) slicing a dissection flap ("powered cheese-wire technique")-after same preparation as above, the middle section of the 0.014 guidewire is removed from the PTFE and bent into a V-shape. Once in the aorta, the guidewire crosses from the true lumen (TL) to the false lumen (FL) and a through-and-through access is obtained. Sheaths are positioned against the flap from both sides and moved up or down while the electricity is activated, slicing the flap and communicating both lumens. Technical success and technical-related complications were evaluated. RESULTS: Eleven cases concerning aortic dissections and 1 case of aortic atresia were treated. Four patients presented urgently, whereas the rest were planned procedures. Seven cases underwent perforation of a dissection flap, 2 cases underwent the powered cheese-wire technique, in 2 cases for an LSA in situ fenestration, and in 1 case to cross an aortic atresia at the aortic isthmus. The technique was in all cases successfully applied. No complications related to the technique occurred. CONCLUSIONS: The "electrified wire" technique is a feasible and ready-available tool that can be safely used in complex aortic interventions, especially to perforate aortic tissue like dissection flaps or to perform in situ fenestrated repairs by perforation of the endograft fabric. CLINICAL IMPACT: The electrified wire technique described herein is a straightforward technique that uses readily available tools to perform electrosurgery. We present its use in complex aortic procedures. However, it could be envisioned for any vascular procedure that requires crossing of the vessel or even prosthetic material. As we have described in this series, when used along with an adequate properative planning, it can be a safe tool of great utility, as has already been demonstarted in the field of the interventional cardiology.

Sex Comparative Analysis of Branched and Fenestrated Endovascular Aortic Arch Repair Outcomes.

OBJECTIVE: Female sex is a risk factor for adverse events after endovascular aortic repair. Sex comparative early and midterm outcomes of fenestrated and branched endovascular aortic arch repair (F/B-Arch) are presented. METHODS: A single centre retrospective sex comparative analysis of consecutive patients managed with F/B-Arch was conducted according to STROBE. Primary outcomes were sex comparative technical success, death, and cerebrovascular morbidity at 30 days. Kaplan-Meier estimates were used for follow up outcomes. RESULTS: Among 209 patients, 38.3% were women. Coronary artery disease (p < .001) and previous myocardial infarction (p = .01) were more common in women. Non-native proximal aortic landing was higher in women (women: 51.3%; men: 31.8%, p = .005) and the aortic dissection rate was lower (28.8% vs. 48.1%, p = .005). Proximal landing to Ishimaru zones showed no difference (zone 0: p = .18; zone 1: p = .47; zone 2: p = .39). Graft configurations were equally distributed. In total, 416 supra-aortic trunks were bridged. The median number of revascularisations per patient was two (interquartile range 1, 3), with no difference between sexes (p = .54). Technical success (women: 97.5%; men: 96.9%, p = .80), 30 day mortality rate (women: 10%; men: 9.3%, p = .86), and cerebrovascular morbidity (women: 11.3%; men: 17.1%, p = .25) were similar. Women presented more access related complications (women: 32.5%; men: 16.3%, p = .006), without affecting access related re-interventions (p = .55). Survival (women: 81.1%, 95% confidence interval [CI] 76.3 - 85.9%; men: 79.8%, 95% CI 76.0 - 83.6%) and freedom from re-intervention (women: 56.6%, 95% CI 50.4 - 62.8%; men: 55.3%, 95% CI 50.1 - 60.5%) at 12 months were similar (log rank, p = .40 and p = .41, respectively). CONCLUSION: Both sexes presented similar outcomes after F/B-Arch. Appropriate patient selection may decrease the effect of sex in F/B-Arch outcomes.

Post-dissection Thoraco-abdominal Aortic Aneurysm Managed by Fenestrated or Branched Endovascular Aortic Repair.

OBJECTIVE: Fenestrated or branched endovascular aortic repair (F/B-EVAR) is a valuable treatment in patients with chronic post-dissection thoraco-abdominal aneurysm (PD-TAAA). This study aimed to analyse early and follow up outcomes of F/B-EVAR in these patients. METHODS: Thirty day and follow up outcomes of consecutive patients with PD-TAAA treated with F/B-EVAR in a tertiary centre over eight years were analysed retrospectively. All patients presenting with PD-TAAA and managed with F/B-EVAR were eligible. A modified Crawford's classification system was used. Thirty day mortality and major adverse event (MAE) rates were analysed. Time to event data were estimated with Kaplan-Meier survival analysis. RESULTS: Fifty five patients (80% men, mean age 63.7 ± 7.7 years) were included: 12 (22%) were managed urgently; 25 (46%) for chronic type B aortic dissection; and the remainder for residual type A aortic dissection. Of these patients, 88% had undergone previous thoracic endovascular aortic repair. Prophylactic cerebrospinal fluid drainage (CSFD) was used in 91%. Fifteen (27%) patients were treated with F-EVAR, nine (16%) with fenestrations and branches, and 31 (56%) with B-EVAR. False lumen adjunctive procedures were used in 56%. Technical success was achieved in 96% of patients. The thirty day mortality rate was 7% and MAE rate was 20%. Spinal cord injury (SCI) grades 1 - 3 and grade 3 rates were 13% and 2%, respectively. Mean follow up was 33.0 ± 18.4 months. Survival and freedom from unscheduled re-intervention were 86% (standard error [SE] 5%) and 55% (SE 8%) at 24 months, respectively. Freedom from target vessel stenosis and occlusion was higher in F-EVAR at the 12 month follow up (p = .006) compared with B-EVAR. CONCLUSION: Fenestrated or branched endovascular repairs in patients with PD-TAAA showed high technical success, with acceptable early mortality and MAE rates. The SCI rate was > 10%, despite CSFD use and staged procedures. Almost a half of patients needed an unscheduled re-intervention within 24 months after F/B-EVAR.

Dilated Internal Iliac Artery Confers a Higher Risk of Endoleak in Iliac Branch Devices in a Single Centre Retrospective Experience.

OBJECTIVE: Iliac branch devices (IBDs) have shown good results but there is little evidence for the risk of internal iliac artery (IIA) endoleak, so there are no clear recommendations on the maximum diameter it should be. Based on limited evidence, it was hypothesised that an IIA of ≥ 11 mm in diameter presents an increased risk of type Ic endoleak. METHODS: This was a single centre, retrospective case control study. Patients undergoing an IBD with the main trunk of the IIA as the target vessel, between 2015 and 2021, were identified. Two groups were created: those with a main trunk diameter of < 11 mm; and those with a diameter of ≥ 11 mm. Technical success, freedom from type Ic endoleak, and re-intervention rates were compared. A receiver operating characteristic (ROC) curve was performed to show a cutoff IIA diameter value for risk of type Ic endoleak. Multivariate analysis was performed to assess the risk of type Ic endoleak and the presence of calcification, stenosis, and landing zone length in the IIA. RESULTS: There were 182 IBDs identified. The dilated IIA group (54 IBDs) had significantly lower technical success (91% vs. 98.4%; p = .002), lower freedom from type Ic endoleak (77% vs. 97.1% at 24 months; p = .001), and lower freedom from re-interventions (70% vs. 92.4% at 24 months; p = .002). The ROC curve showed that 10.5 mm was the cutoff diameter for type Ic endoleak. Moderate or severe calcification as well as landing zone length < 5 mm also correlated with type Ic endoleak. CONCLUSION: IBDs have a statistically significantly higher rate of technical failure, lower freedom from type Ic endoleak, and lower freedom from re-intervention when the IIA is ≥ 11 mm in diameter.