One-hundred Consecutive Physician-Modified Fenestrated Endovascular Aneurysm Repair of Pararenal and Thoracoabdominal Aortic Aneurysms Using the Terumo TREO Stent Graft.

BACKGROUND: Fenestrated endovascular aortic aneurysm repair (FEVAR) has been widely applied for the treatment of pararenal (PAA) and thoracoabdominal aortic aneurysms (TAAA). If custom-made devices or off-the-shelf devices are not available, physician-modified endografts (PMEGs) are an alternative device option. Several different endograft platforms have been used for PMEG; however, minimal data exists on utilizing the Terumo TREO abdominal stent graft system in this setting. The purpose of this study was to evaluate our single-center experience treating PAA and TAAA, with a physician-modified FEVAR, using the Terumo TREO platform. METHODS: A prospective database of consecutive patients with PAA and TAAA treated at a single center, with a FEVAR, utilizing a PMEG device between March 2021 and September 2023 was queried for those having a Terumo TREO device implanted. The demographics, operative details, and postoperative complications were analyzed. The rates of technical success, type I or III endoleak, branch vessel status, reintervention, and 2-year survival were also assessed. RESULTS: Of the 153 patients who underwent FEVAR with a PMEG device during the study period, 100 had repair using a Terumo TREO stent graft. The mean age of the cohort was 73.7 ± 7.0 years with the majority suffering from hypertension (n = 94, 94%), coronary artery disease (n = 51, 51%), and chronic obstructive pulmonary disease (n = 40, 40%). Thirty-four patients (34%) had a prior failed EVAR device in place. The mean aneurysm size was 66.0 ± 13.7 mm, with 58 (50%) patients classified as PAA and 30 (30%) patients as an extent IV TAAA. Six (6%) patients presented with symptomatic/ruptured aneurysms. The average number of target arteries incorporated per patient was 3.8 ± 0.6. The overall technical success was 99%, procedure time was 218 ± 116 min, contrast volume was 82 ± 21 mL, and cumulative air kerma was 3,054 ± 1,560 mGy. Postoperative complications were present in 20 patients (20%), and 2 patients (2%) died within 30 days. Rates of type I or III endoleak, branch vessel stenosis or occlusion, and reintervention were 2%, 1%, and 7%, respectively. The two-year overall survival was 87%. CONCLUSIONS: Treatment of PAA and the extent IV TAAA using a physician-modified fenestrated Terumo TREO endograft is safe and effective. This large, early experience using the Terumo TREO platform supports preferential use of this device in this setting due to the device design and low likelihood of type I or III endoleak.

Endovascular Salvage of Type Ia and Ib Endoleaks Using a Physician-Modified Fenestrated/Branched Endograft and an Iliac Branch Device Via Unilateral Transfemoral Arterial Access.

PURPOSE: This study aims to explore the feasibility and effectiveness of a unilateral transfemoral access endovascular salvage technique for complex abdominal aortic aneurysms with concurrent type Ia and Ib endoleaks following previous endovascular repair. CASE REPORT: A 69-year-old female with multiple comorbidities presented with an extent IV thoracoabdominal aortic aneurysm complicated by type Ia and Ib endoleaks and chronically occluded left iliac endoprosthesis after prior endovascular repair. Given the patient's medical complexities, open explant repair was deemed high risk. The case was successfully managed using a physician-modified fenestrated/branched endograft (PM-F/BEVAR) and an iliac branch device (IBD) deployed through a single percutaneous transfemoral access. CONCLUSION: The presented case demonstrates the safety and efficacy of PM-F/BEVAR with concomitant IBD deployment via unilateral transfemoral access. This innovative approach allows endovascular salvage in cases with restricted iliofemoral access and avoids the complexities associated with upper extremity or aortic arch manipulation. While acknowledging the technical challenges, this technique offers a viable alternative for salvaging failed endovascular repairs, emphasizing the importance of real-time modifications in achieving successful outcomes. Further studies and long-term follow-up are warranted to validate the broader applicability and durability of this approach in the management of complex abdominal aortic aneurysms with multiple endoleaks. CLINICAL IMPACT: Although not the conventional approach, unilateral transfemoral access can be utilized to implant either a physician-modified fenestrated aortic endograft or an iliac branch device. Such an approach avoids complicating issues related to upper extremity access. This innovative technique may be necessary when there is a failed prior EVAR in the setting of significant contralateral iliofemoral occlusive disease. Doing both procedures in the same setting to resolve a type Ia and Ib endoleak is feasible as demonstrated in this case report. Expanding the endovascular armamentarium to address EVAR failure will be increasingly useful in the future, especially given the morbidity profile of EVAR explantation.

Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System.

BACKGROUND: An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths. METHODS: The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure. RESULTS: A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88). CONCLUSIONS: In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558.

Definition and Perception of Autonomy in Vascular Surgery Training.

BACKGROUND: There is a lack of data evaluating operative autonomy within vascular surgery. This study aims to determine where discrepancies exist in the definition of autonomy between trainees and attending faculty. METHODS: An Institutional Review Board-approved, anonymous survey was e-mailed to vascular trainees and attending faculty at all Accreditation Council for Graduate Medical Education-approved vascular surgery training programs in the United States. Data were compared using chi-square statistical analysis. RESULTS: One-hundred forty-nine responses from vascular surgery trainees (n = 89) and faculty (n = 60) were obtained. The most highly ranked preoperative skill by trainees was Case Planning, at all post-graduate year-levels. Although a majority of trainees believe this skill is expected of them, only 36.1% of attendings responded that they expect all trainee levels to perform this task. Draping/positioning was ranked as the second most important intraoperative task for all post-graduate year-levels by attendings; however, only 32.8% of attendings expect trainees to perform this. Exposure of Critical Structures was ranked as the most important intraoperative task by both trainees and attendings at the Chief and Fellow level. However, responses by both trainees and attendings showed that this is expected <70% of the time. When asked about double-scrubbing independently of other tasks, most trainees assessed double-scrubbing as inherently important to autonomy at all levels of training and within all regions. Only 44.3% of attendings responded that they expect all trainees to double-scrub. Additionally, most trainees in all regions responded that they spend <25% of cases double-scrubbed. CONCLUSIONS: These responses show a discrepancy between the skills that both trainees and attendings deem important to autonomy versus what is being expected of trainees in reality.

Cutdown is Associated with Higher 30-day Unplanned Readmissions and Wound Complications than Percutaneous Access for EVAR.

BACKGROUND: A 2023 Cochrane review showed no difference in bleeding/wound infection complications, short-term mortality and aneurysm exclusion between the percutaneous and cut-down approach for femoral access in endovascular aortic aneurysm repair (EVAR). In contrast, single-center studies have shown bilateral cutdown resulting in higher readmission rates due to higher rates of groin wound infections. Whether 30-day readmission rates vary by type of access during EVAR procedures is unknown. The goal of this study was to ascertain which femoral access approach for EVAR is associated with the lowest risk of 30-day readmission. METHODS: The Targeted Vascular Module from the American College of Surgeons National Surgical Quality Improvement Program was queried to identify patients undergoing EVAR for aortic disease from 2012-2021. All ruptures and other emergency cases were excluded. Cohorts were divided into bilateral cutdown, unilateral cutdown, failed percutaneous attempt converted to open and successful percutaneous access. The primary 30-day outcomes were unplanned readmission and wound complications. Univariate analyses were performed using the Fisher's exact test, Chi-Square test and the Student's t-test. Multivariable analysis was performed using logistic regression. RESULTS: From 2012 to 2021, 14,002 patients met study criteria. Most (7,395 [53%]) underwent completely percutaneous access, 5,616 (40%) underwent bilateral cutdown, 849 (6%) underwent unilateral cutdown, and 146 (1%) had a failed percutaneous access which was converted to open. Unplanned readmissions by access strategy included 7.6% for bilateral cutdown, 7.3% for unilateral cutdown, 7.8% for attempted percutaneous converted to cutdown, and 5.7% for completely percutaneous access (P < 0.001, Figure 1). After multivariable analysis, unplanned readmissions compared to percutaneous access yielded: percutaneous converted to cutdown adjusted odds ratio (AOR): 1.38, 95% CI [0.76-2.53], P = 0.29; unilateral cutdown AOR: 1.18, 95% CI [0.92-1.51], P = 0.20; bilateral cutdown AOR: 1.26, 95% CI [1.09-1.43], P = 0.001. Bilateral cutdown was also associated with higher wound complications compared to percutaneous access (AOR: 4.41, CI [2.86-6.79], P < 0.001), as was unilateral cutdown (AOR: 3.04, CI [1.46-6.32], P = 0.003). CONCLUSIONS: Patients undergoing cutdown for EVAR are at higher risk for 30-day readmission compared to completely percutaneous access. If patient anatomy allows for percutaneous EVAR, this access option should be prioritized.

The Effects of Clopidogrel Duration on Carotid Artery In-Stent Restenosis.

BACKGROUND: There are limited data supporting a specific duration for dual antiplatelet therapy in carotid artery stenting (CAS), and most clinical evidence is derived from studies involving coronary interventions. As a result, the appropriate duration of dual antiplatelet therapy after CAS is yet to be determined. We aimed to elucidate whether the duration of dual antiplatelet therapy played a role in the rate of carotid in-stent restenosis. METHODS: A retrospective analysis of all patients who underwent CAS at our institution over a 20-year period (1996-2016) was performed (n = 279). Patients who did not complete their follow-up duplex studies or were not discharged on clopidogrel were excluded from the study. Patients were separated into short-term (<6 weeks, n = 159) and long-term (>6 weeks, n = 112) clopidogrel users based on duration of therapy. We defined clinically significant in-stent restenosis as >50% restenosis (peak systolic velocity = 224 cm/s) in symptomatic patients and >80% restenosis (peak systolic velocity = 325 cm/s) in asymptomatic patients status-post prior CAS based on published velocity criteria. Rates of in-stent restenosis at 1-year, 2-year, and 5-year intervals were analyzed between the 2 groups using chi-squared analysis. RESULTS: Demographic information was largely similar between the 2 groups; however, short-term clopidogrel users were more likely to have a history of atrial fibrillation (9.43% vs. 1.68%, P = 0.008) and were less likely to have a history of coronary artery bypass graft (16.35% vs. 29.41%, P = 0.009), diabetes (33.34% vs. 49.58%, P = 0.006), and coronary artery disease (50.31% vs. 63.03%, P = 0.035). All patients were on long-term aspirin therapy. There was no significant difference between overall rates of in-stent restenosis between the short-term and long-term clopidogrel users (5.03% vs. 9.24%, P = 0.168) within 5 years of the index procedure. Similar results were observed when these groups were evaluated at 1-year (5.61% vs. 3%, P = 0.321), 2-year (2.02% vs. 6.59%, P = 0.072), and 5-year (2.24% vs. 3.57%, P = 0.635) follow-up. CONCLUSIONS: No statistically significant difference was observed in the rate of in-stent restenosis after CAS between short-term and long-term clopidogrel therapy. Patients in whom there is no other indication for longer duration clopidogrel therapy may be considered for shorter duration course of dual antiplatelet therapy following CAS.