Three-Year Outcomes of a US Pivotal Trial Substudy for Conformable Endoprosthesis in >=10 mm Non-Angulated Neck Anatomy.

OBJECTIVE: To report the midterm clinical outcomes from the GORE® EXCLUDER® Conformable AAA Endoprosthesis system (EXCC) pivotal regulatory trial in the United States (U.S.). METHODS: This is a prospective, multicenter, investigational device exemption clinical trial at 31 U.S. sites with Core Laboratory assessment of imaging and independent adjudication of safety. The study enrolled patients with abdominal aortic aneurysms (AAA) with a minimum proximal landing zone ≥ 10mm and proximal neck angulation of ≤ 60 degrees between December 2017 and February 2019 as part of a larger study to gain indications of the EXCC device. Endpoints included patient survival, freedom from secondary interventions, and stent-graft related outcomes. RESULTS: There were 80 patients enrolled (88.8% male, mean 73.5 ± 8.14 years-old). Mean maximum aortic diameter was 57.7±8.0 mm (range, 42.5-82.7). There was 100% freedom from type I and III endoleak and aneurysm-related mortality at 36-months. Freedom from secondary intervention was 91.9 ± (0.83, 0.96, 95% C.I.) at 36-months. There were no device fractures, migrations (>=10 mm), or aneurysm ruptures. At 36 months, thirteen patients (26.5%) had type 2 endoleak, 32 patients (58.2%) had AAA sac regression, 17 (30.9%) had no change in diameter, and 6 (10.9%) had sac enlargement. Seven patients (8.8%) through 36 months underwent reintervention. CONCLUSIONS: The 3-year outcomes have continued to show an adequate safety and efficacy profile of the EXCC device with no aneurysm related mortality or Type I/III endoleak. These results demonstrate durability for an EVAR device in US regulatory trials.

Early Results From the Pivotal Trial Substudy of the GORE® EXCLUDER® Conformable Endoprosthesis in Angulated Necks.

OBJECTIVE OR BACKGROUND: To report the investigational device exemption (IDE) study 1-year clinical outcomes of the high neck angulation (HNA) substudy of the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) for treatment of infrarenal abdominal aortic aneurysms (AAA). METHODS: This study is a prospective, multicenter clinical trial conducted in the United States and included core laboratory assessment of imaging and independent event adjudication. Anatomic criteria for enrollment in the HNA substudy included infrarenal aortic neck angulation >60° and ≤90° with aortic neck length ≥10 mm. Primary safety endpoints included blood loss >1000 mL, death, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure, and thromboembolic events. Primary effectiveness endpoints included technical success, absence from Type I and III endoleak, migration (≥10 mm), sac enlargement (≥5 mm), sac rupture, and conversion to open repair. RESULTS: Between January 2018 and February 2022, 95 patients were enrolled in the HNA substudy across 35 sites. Of the 95 patients, 71 (74.7%) were male and the cohort average age was 74.4 years old. The mean infrarenal proximal aortic neck angle was 71.6° and mean AAA size was 62.9 mm. Overall technical success was achieved in 93 (97.9%) patients. Freedom from a primary safety endpoint through 30 days was 96.7%; 3 (3.3%) patients had blood loss >1000 mL. Freedom from the primary effectiveness at 12 months was achieved in 94.8%. Four (4.3%) patients had Type IA endoleak; intervention after the procedure was not required and no subsequent interventions or sac enlargement were noted in these patients. At 12 months, 29 (39.7%) patients experienced a Type II endoleak and 1 (1.3%) patient experienced AAA sac expansion ≥5mm. Through 12 months, 1 (1.3%) patient had a conversion to open surgical repair. There were no aneurysm-related deaths, ruptures, or migration through 12 months. CONCLUSIONS: The IDE study demonstrates safety and effectiveness of the EXCC device in AAA with highly angulated necks (>60° and ≤90°) are preserved at the 12-month follow-up.

Hybrid approach to achieve secure distal seal zones during endovascular aortic repair in a patient with Marfan syndrome.

This report details a hybrid approach for treatment of abdominal aortic aneurysm in a patient with Marfan syndrome (MFS). A 34-year-old patient with MFS and prior open thoracoabdominal aortic aneurysm repair underwent bilateral common iliac artery interposition graft repair and endovascular aortic repair. The bifurcated stent graft was implanted into the previous thoracoabdominal graft proximally and iliac interposition grafts distally. Postoperatively, the patient recovered uneventfully with sac regression to 4.5 cm through 2-year follow-up, without seal zone degeneration. This hybrid approach aimed to eliminate landing zone degeneration in patients with MFS undergoing endovascular repair.

Three-year outcomes of off-the-shelf Gore thoracoabdominal multibranch endoprosthesis and physician-modified endografts for complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: Fenestrated-branched endovascular aortic repair (FB-EVAR) has shown favorable outcomes for repair of complex aneurysms and thoracoabdominal aortic aneurysms. Physician-modified endografting (PMEG) and the Gore thoracoabdominal multibranch endoprosthesis (TAMBE) provide custom and off-the-shelf devices for FB-EVAR, respectively. This study compares the outcomes of TAMBE and PMEG at a single institution. METHODS: A retrospective review of patients who underwent TAMBE as part of the multicenter pivotal trial or PMEG as part of a prospective physician-sponsored investigational device exemption at a single institution between 2020 and 2022 were completed. Patient demographics, characteristics, and perioperative and midterm outcomes were compared. RESULTS: A total of 68 patients were included, with 12 in the TAMBE group and 56 in the PMEG group. Baseline characteristics were comparable between groups. Aneurysm type was most often thoracoabdominal aortic aneurysm in both groups (58% TAMBE and 52% PMEG). TAMBE had a higher rate of upper extremity access (100% vs 63%; P = .013) and longer mean procedure time (247 ± 36 minutes vs 189 ± 49 minutes; P < .001). Other intraoperative metrics were similar between groups. Technical success was 100% in TAMBE and 95% in PMEG (P = .412). There was no 30-day mortality in either group. No major adverse events occurred with TAMBE, whereas in PMEG cases, 2% had respiratory failure, 2% required dialysis, and 4% experienced spinal cord ischemia. Although the overall endoleak rates were similar (50% of TAMBE vs 41% of PMEG; P = .57), type II endoleaks accounted for all of the endoleaks in the TAMBE group, whereas type I or III endoleaks were seen in 11% of PMEG patients. At a median follow-up of 26.7 months for the TAMBE group and 21.2 months for the PMEG group, target vessel instability was seen in 10.4% of TAMBE, and 6.9% of PMEG targeted branches (P = .401). Reintervention was required in 33% of TAMBE patients and 27% of PMEG patients (P = .646). Estimated freedom from reintervention rates at 3 years were similar (56% TAMBE vs 62% PMEG, log-rank P = .910). Freedom from visceral renal target vessel instability at 3 years was 89% for both groups (log-rank P = .459). The Kaplan-Meier 3-year estimated survival was 100% for patients in the TAMBE group and 77% for patients in the PMEG group (log-rank P = .157). CONCLUSIONS: At experienced centers, FB-EVAR can be completed with PMEG or TAMBE with comparable, excellent perioperative and midterm outcomes. Reinterventions are frequently needed for both TAMBE and PMEG.

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.

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.

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.

Spinal cord ischemia and reinterventions following thoracic endovascular repair for acute type B aortic dissections.

OBJECTIVE: The technical aspects of thoracic endovascular aortic repair (TEVAR) for acute type B aortic dissection (TBAD), specifically the location of proximal seal zone (PSZ) (need to cover the left subclavian artery [LSA]), distal seal zone (DSZ) (length of aortic coverage), benefit of LSA revascularization, and prophylactic lumbar drainage are still debated. Each of these issues has potential benefits but also has known risks. This study aims to identify factors associated with reintervention and spinal cord ischemia (SCI) following TEVAR for acute TBAD with a zone 3 entry tear. METHODS: The Vascular Quality Initiative was queried for TEVARs performed for acute TBAD with zone 3 entry tear, zone 3 proximal zone of disease, treated with TEVAR extending between zone 2 and zone 5. The primary outcomes were SCI and related reintervention. Secondary outcomes were stroke, arm ischemia, and retrograde type A dissection (RTAD). The exposure variables were PSZ 2 vs 3, DSZ 4 vs 5, prophylactic lumbar drain, and LSA revascularization. Univariate analyses were conducted with χ2 analysis, and multivariable logistic regression was used to evaluate association with outcomes. RESULTS: Of 583 patients who met inclusion criteria, 266 had PSZ 2 and 317 had PSZ 3. On univariate analysis, PSZ 2 was associated with a higher rate of reintervention, but PSZ2 was not significant on multivariable analysis after accounting for age, sex, race, smoking, PSZ, DSZ, prophylactic lumbar drain, and LSA patency. PSZ 2 was not associated with SCI, arm ischemia, or RTAD. PSZ 2 was associated with a trend towards a higher rate of stroke. DSZ 4 and DSZ 5 were performed in 161 and 422 TEVARs, respectively, and DSZ 5 was associated with a higher rate of SCI on univariate (3 [1.9%] vs 39 [9.2%]; P = .01) and multivariable (odds ratio, 7.384; 95% confidence interval, 2.193-24.867; P = .001) analyses. Prophylactic lumbar drain placement was not statistically significantly associated with SCI, but lack of postoperative LSA patency was associated with SCI (odds ratio, 2.966; 95% confidence interval, 1.016-8.656; P = .05). CONCLUSIONS: This study found that PSZ 2 was not associated with lower reinterventions or higher rates of SCI but trended towards a higher rate of stroke than PSZ 3. Additionally, DSZ 5 was strongly associated with SCI when compared with DSZ 4, highlighting the importance of limiting aortic coverage to coverage of the proximal entry tear when possible.

In situ laser fenestration of aortic septum to bridge false and true lumen during endovascular repair of aortic dissection.

Fenestration of the septum between the true and false lumen might be necessary after aortic dissection. We report the technical aspects of in situ laser fenestration of the aortic dissection septum. Two illustrative cases are provided: a 56-year-old man with false lumen deployment of a frozen elephant trunk graft, and a 67-year-old man who underwent fenestrated endovascular aortic repair with a target branch vessel off the false lumen. In both cases, the septum was crossed using in situ laser fenestration. This technique is a precise option to enable passage between true and false lumens during endovascular repair of an aortic dissection.

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

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

Use of Iliac Branch Endoprosthesis to Rescue Inadvertent False Lumen Deployment of the Innominate Branch Stent During Physician-Modified Fenestrated-Branched Aortic Arch Repair.

A 70-year-old male with a history of 3 prior median sternotomies and on anticoagulation presented with acute chest and back pain associated with a pseudoaneurysm of the ascending and aortic arch in the setting of residual dissection involving the innominate, proximal right carotid, and subclavian arteries. A physician-modified triple vessel fenestrated-branched arch endograft was deployed. The innominate branch stent was deployed from the right carotid cut down, while the left carotid and left subclavian branch stents were placed from a femoral approach. Postoperatively, the innominate branch was found to be deployed in the false lumen of the dissected native innominate artery, leading to continued pressurization of the pseudoaneurysm. This was rescued by placing a Gore Iliac Branch Endoprosthesis (IBE) into the innominate branch through a temporary conduit sewn to the right carotid artery with a right subclavian branch placed via a brachial artery cut down into the internal iliac gate. The use of IBE allowed branch stent extension past the dissected native vessels. The patient had an uneventful recovery without neurologic complications. At 3-month follow-up, the patient remains well with an excluded pseudoaneurysm, and patent bifurcated innominate, bilateral carotid, and subclavian artery branches. A Gore IBE can be utilized in a dissected innominate artery to create an innominate branch device during fenestrated-branched endovascular arch repair.

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

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

Incorporation of internal iliac arteries as target vessels during physician-modified fenestrated branched endovascular repair of pararenal abdominal aortic aneurysm with concomitant bilateral short common iliac artery aneurysms.

This report describes an alternative endovascular approach to iliac branch devices for treatment of an abdominal aortic aneurysm with concomitant bilateral short common iliac aneurysms. The short distance between the renal arteries and internal iliac artery origins made the addition of distal iliac branch devices to the proximal fenestrated stent graft challenging. We elected to perform physician-modified fenestrated branched endovascular repair, using four fenestrations for the visceral and renal arteries and an additional two directional branches for the bilateral internal iliac arteries. The patient recovered uneventfully, and the 24-month follow-up imaging shows successful aneurysm exclusion with patent internal iliac artery branches.

Techniques and Limitations of Gore Thoracoabdominal Multibranch Endoprosthesis (TAMBE) for Type 1A Endoleak After Failed Endovascular Aortic Repairs.

PURPOSE: Endovascular aortic aneurysm repair (EVAR) is the dominant treatment modality over open repair for abdominal aortic aneurysms. However, a higher rate of reinterventions remains the Achilles heel of EVAR. Although type 1A endoleak from proximal seal zone failure of EVAR remains one of the leading causes for reintervention, fenestrated branched devices suitable for proximal extension of failed EVAR are not widely available in the United States. Gore Thoracoabdominal Multibranch Endoprosthesis (TAMBE) is an off-the-shelf investigational device that provides supraceliac seal by incorporating 4 visceral and renal arteries via preloaded inner branches. CASE REPORT: In this article, we describe 2 cases of type 1A endoleak from previous EVAR devices repaired using TAMBE. Both cases were performed under the Food and Drug Administration (FDA) compassionate use exemption. Considerations on the case planning and implantation techniques of TAMBE specific to previous EVAR devices are reviewed. CONCLUSIONS: Gore TAMBE can be utilized to repair a type 1A endoleak of a previous infrarenal EVAR device. Greater supraceliac coverage necessary for TAMBE relative to the minimal seal zone should be considered when applying this device for a type 1A endoleak. CLINICAL IMPACT: This report demonstrates the feasibility of applying off-the-shelf TAMBE device to treat one of the most common failure modes of EVAR, type1A endoleak.

Aortic rupture during STABILISE (stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair) technique.

The STABILISE (stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair) technique has shown promising results for treating type B aortic dissections, but the potential exists for fatal adverse effects. We present a case of infrarenal aortic rupture while using a compliant balloon to balloon mold the true lumen inside previously placed bare metal stents during the STABILISE technique. Caution is advised for providers who wish to perform the STABILISE technique, and we recommend using a semi-compliant balloon sized to the smallest total aortic diameter to mitigate the risk of rupture.

Sandwich thoracic branch endoprosthesis technique for endovascular repair of thoracic aortic aneurysm with aberrant right subclavian artery.

Subclavian artery coverage is frequently required to achieve an adequate proximal seal during thoracic endovascular aortic repair. The thoracic branch endoprosthesis (TBE; W.L. Gore & Associates) is the first U.S. Food and Drug Administration-approved branched device for thoracic endovascular aortic repair, designed for left subclavian artery incorporation. However, anatomic suitability of the TBE has been shown to be limited. In the present report, we describe a novel technique using the TBE in a sandwich periscope configuration to allow for emergent repair of a ruptured thoracic aortic aneurysm with a highly angulated proximal seal zone and aberrant right subclavian artery.

Branch-first aortic arch replacement strategy decreases perioperative mortality.

OBJECTIVE: Sparce evidence suggests superiority of total arch replacement with the branch-first technique and antegrade cerebral perfusion over conventional techniques with respect to morbidity and mortality. Thus, we aimed to compare perioperative outcomes of patients undergoing traditional total arch replacement versus branch-first total arch replacement. METHODS: We retrospectively reviewed 144 patients undergoing total arch replacement from January 2017 to December 2021. Patients were dichotomized based on technique, either traditional total arch replacement or branch-first total arch replacement. Primary end points were 30-day mortality and adverse events. Branch-first total arch replacement and traditional total arch replacement cohorts were compared using Student t tests and chi-square tests. Univariable and multivariable logistic regressions were performed to identify risk factors associated with 30-day mortality. RESULTS: A total of 68 patients (47.2%) underwent traditional total arch replacement, and 76 patients (52.8%) underwent branch-first total arch replacement. The branch-first total arch replacement cohort had higher rates of chronic kidney disease, hypertension, atrial fibrillation, and previous myocardial infarction (P = .04, .002, .035, and .031 respectively). The majority of total arch replacements (78, 55%) were performed for aneurysmal disease. Median antegrade cerebral perfusion times were significantly shorter in the branch-first total arch replacement cohort (P = .001). There were no significant differences in rates of stroke, reintubation, postoperative lumbar drainage, renal failure, reoperation for bleeding, or prolonged ventilation between total arch replacement cohorts. The branch-first total arch replacement group had significantly lower 30-day mortality compared with the traditional total arch replacement group (4% vs 19%, P = .004). After adjustment for chronic kidney disease, nonelective status, antegrade cerebral perfusion time, rates of dissections arriving in extremis or with malperfusion, and primary surgeon, undergoing a branch-first total arch replacement was associated with a 93% reduced odds of 30-day mortality (odds ratio, 0.07, 95% CI, 0.009-0.48, P = .007). CONCLUSIONS: We provide evidence that branch-first total arch replacement significantly reduces 30-day mortality compared with traditional total arch replacement.

Near-wall hemodynamic changes in subclavian artery perfusion induced by retrograde inner branched thoracic endograft implantation.

Objective: Left subclavian artery (LSA)-branched endografts with retrograde inner branch configuration (thoracic branch endoprosthesis [TBE]) offer a complete endovascular solution when LSA preservation is required during zone 2 thoracic endovascular aortic repair. However, the hemodynamic consequences of the TBE have not been well-investigated. We compared near-wall hemodynamic parameters before and after the TBE implantation using computational fluid dynamic simulations. Methods: Eleven patients who had undergone TBE implantation were included. Three-dimensional aortic arch geometries were constructed from the pre- and post-TBE implantation computed tomography images. The resulting 22 three-dimensional aortic arch geometries were then discretized into finite element meshes for computational fluid dynamic simulations. Inflow boundary conditions were prescribed using normal physiological pulsatile circulation. Outlet boundary conditions consisted of Windkessel models with previously published values. Blood flow, modeled as Newtonian fluid, simulations were performed with rigid wall assumptions using SimVascular's incompressible Navier-Stokes solver. We compared well-established hemodynamic descriptors: pressure, flow rate, time-averaged wall shear stress (TAWSS), the oscillatory shear index (OSI), and percent area with an OSI of >0.2. Data were presented on the stented portion of the LSA. Results: TBE implantation was associated with a small decrease in peak LSA pressure (153 mm Hg; interquartile range [IQR], 151-154 mm Hg vs 159 mm Hg; IQR, 158-160 mm Hg; P = .005). No difference was observed in peak LSA flow rates before and after implantation: 40.4 cm3/ (IQR, 39.5-41.6 cm3/s) vs 41.3 cm3/s (IQR, 37.2-44.8 cm3/s; P = .59). There was a significant postimplantation increase in TAWSS (15.2 dynes/cm2 [IQR, 12.2-17.7 dynes/cm2] vs 6.2 dynes/cm2 [IQR, 5.7-10.3 dynes/cm2]; P = .003), leading to decreases in both the OSI (0.088 [IQR, 0.063 to -0.099] vs 0.1 [IQR, 0.096-0.16]; P = .03) and percentage of area with an OSI of >0.2 (10.4 [IQR, 5.8-15.8] vs 15.7 [IQR, 10.7-31.9]; P = .13). Neither LSA side branch angulation (median, 81°, IQR, 77°-109°) nor moderate compression (16%-58%) seemed to have an impact on the pressure, flow rate, TAWSS, or percentage of area with an OSI of >0.2 in the stented LSA. Conclusions: The implantation of TBE produces modest hemodynamic disturbances that are unlikely to result in clinically relevant changes.

Dual-Lumen Stenting of Dissected Superior Mesenteric Artery During Fenestrated Branched Endovascular Repair of a Post-dissection Thoracoabdominal Aortic Aneurysm.

PURPOSE: Long-segment aortic branch dissections have been considered a relative contraindication for fenestrated-branched endovascular aneurysm repair (FB-EVAR). This case report describes a technique of dual-lumen stenting of a fully-dissected superior mesenteric artery (SMA) to preserve patency of the true and false lumens during FB-EVAR. CASE REPORT: A 67-year-old man presented with a 6.0 cm extent III chronic post-dissection thoracoabdominal aortic aneurysm. The patient had highly-complex anatomy including dissection of the entire SMA. The true and false lumens of the dissected SMA were noted to be supplying different branches, requiring preservation of both lumens. The patient underwent a staged physician-modified FB-EVAR. A modified endograft containing 5 fenestrations and 1 branch cuff was introduced and the celiac, true-lumen SMA, and 3 renal arteries were sequentially catheterized using staggered deployment of the modified endograft. The false lumen SMA stent was catheterized via the branch cuff. Molded parallel grafting ("eye-of-the-tiger") technique was used to achieve double D configuration between the true and false lumens of the SMA. CONCLUSION: This case demonstrates feasibility of dual-lumen stenting to incorporate dissected target vessels during FB-EVAR while preserving flow to both the true and false lumens and the second-order branches they supply. CLINICAL IMPACT: We report a novel technique that allows incorporation of branch vessels affected by long segment dissection during fenestrated branched endovascular aortic repairs. This has potential advantage of preserving flow to all secondary branches of the dissected target vessels, while reducing the risk of type Ic endoleak.