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.

Comparative outcomes of physician-modified fenestrated/branched endovascular aortic aneurysm repair in the setting of prior failed endovascular aneurysm repair.

OBJECTIVE: Endovascular treatment of aortic aneurysms involving renal-mesenteric arteries, especially in the setting of prior failed endovascular aneurysm repair (EVAR) typically requires fenestrated/branched endovascular aneurysm repair (F/BEVAR) with a custom-made device (CMD). CMDs are limited to select centers, and physician-modified endografts are an alternative treatment platform. Currently, there is no data on the outcomes of physician-modified F/BEVAR (PM-F/BEVAR) in the setting of failed prior EVAR. The purpose of this study was to evaluate the use of PM-F/BEVAR in patients with prior failed EVAR. METHODS: A prospective database of consecutive patients treated at a single center with PM-F/BEVAR between March 2021 and November 2022 was retrospectively reviewed. The cohort was stratified by presence of a failed EVAR (type Ia endoleak or aneurysm development proximal to a prior EVAR) prior to PM-F/BEVAR. Demographics, operative details, and postoperative complications were compared between the groups using univariate analysis. One-year survival and freedom from reintervention were compared using the Kaplan-Meier method. RESULTS: A total of 103 patients underwent PM-F/BEVAR during the study period; 27 (26%) were in the setting of prior EVAR. Patients with prior failed EVAR had similar age (75.2 ± 7.7 vs 71.5 ± 8.8 years; P = .058), male gender (n = 24 ; 89% vs n = 57 ; 75%; P = .130), and comorbid conditions except higher incidence of moderate-to-severe chronic obstructive pulmonary disease (n = 7 ; 26% vs n = 7 ; 9%; P = .047). Overall, aneurysm diameter was 65.5 ± 13.9 mm with aneurysms categorized as juxta-/pararenal in 43% and thoracoabdominal in 57%, with no differences between the groups. Twelve patients (14%) presented with symptomatic/ruptured aneurysms. The average number of target arteries incorporated per patient was 3.8. Four different aortic devices were modified with a greater proportion of Terumo TREO devices used in the failed EVAR group (P = .03). There was no difference in procedure time, radiation dose, or iodinated contrast use between groups. Overall technical success was 99%. Rates of 30-day mortality (n = 0 ; 0% vs n = 3 ; 4%; P = .565) and major adverse events (n = 6 ; 22% vs n = 16 ; 21%; P = 1.0) were similar between groups. For the overall cohort, rates of type 1 or 3 endoleak, branch vessel stenosis/occlusion, and reintervention were 2%, 1%, and 8%, respectively, with no difference between groups. One-year survival (failed EVAR 94% vs no EVAR 82%; P = .756) was similar between groups. CONCLUSIONS: PM-F/BEVAR is a safe and effective treatment for patients with aneurysms involving the renal-mesenteric arteries in the setting of prior failed EVAR where additional technical challenges may be present. Additional follow-up is warranted to demonstrate long-term efficacy, but early results are encouraging and similar to those using CMDs.

Configuration affects parallel stent grafting results.

OBJECTIVE: A number of adjunctive "off-the-shelf" procedures have been described to treat complex aortic diseases. Our goal was to evaluate parallel stent graft configurations and to determine an optimal formula for these procedures. METHODS: This is a retrospective review of all patients at a single medical center treated with parallel stent grafts from January 2010 to September 2015. Outcomes were evaluated on the basis of parallel graft orientation, type, and main body device. Primary end points included parallel stent graft compromise and overall endovascular aneurysm repair (EVAR) compromise. RESULTS: There were 78 patients treated with a total of 144 parallel stents for a variety of pathologic processes. There was a significant correlation between main body oversizing and snorkel compromise (P = .0195) and overall procedural complication (P = .0019) but not with endoleak rates. Patients were organized into the following oversizing groups for further analysis: 0% to 10%, 10% to 20%, and >20%. Those oversized into the 0% to 10% group had the highest rate of overall EVAR complication (73%; P = .0003). There were no significant correlations between any one particular configuration and overall procedural complication. There was also no significant correlation between total number of parallel stents employed and overall complication. Composite EVAR configuration had no significant correlation with individual snorkel compromise, endoleak, or overall EVAR or procedural complication. The configuration most prone to individual snorkel compromise and overall EVAR complication was a four-stent configuration with two stents in an antegrade position and two stents in a retrograde position (60% complication rate). The configuration most prone to endoleak was one or two stents in retrograde position (33% endoleak rate), followed by three stents in an all-antegrade position (25%). There was a significant correlation between individual stent configuration and stent compromise (P = .0385), with 31.25% of retrograde stents having any complication. CONCLUSIONS: Parallel stent grafting offers an off-the-shelf option to treat a variety of aortic diseases. There is an increased risk of parallel stent and overall EVAR compromise with <10% main body oversizing. Thirty-day mortality is increased when more than one parallel stent is placed. Antegrade configurations are preferred to any retrograde configuration, with optimal oversizing >20%.

32P as an adjunct to standard therapy for locally advanced unresectable pancreatic cancer: a randomized trial.

This prospective randomized trial was undertaken to determine the added efficacy of (32)P in treating locally advanced unresectable pancreatic cancer. Thirty patients with biopsy proven locally advanced unresectable adenocarcinoma of the pancreas were assessable after receiving 5-fluorouracil and radiation therapy with or without (32)P, followed by gemcitabine. Intratumoral (32)P dose was determined by tumor size and volume and was administered at months 0, 1, 2, 6, 7, and 8. Tumor cross-sectional area and liquefaction were determined at intervals by computed tomography scan. Tumor liquefaction occurred in 78% of patients receiving (32)P and in 8% of patients not receiving (32)P, although tumor cross-sectional area did not decrease. Serious adverse events occurred more often per patient for patients receiving (32)P (4.2 +/- 3.1 vs. 1.8 +/- 1.9; p = 0.03) leading to more hospitalizations. Death was because of disease progression (23 patients), gastrointenstinal hemorrhage (4 patients), and stroke (1 patient). One patient not receiving (32)P and one receiving (32)P are alive at 28 and 13 months, respectively. (32)P did not prolong survival (7.4 +/- 5.5 months with (32)P vs. 11.5 +/- 8.0 months without (32)P, p = 0.16). (32)P promoted tumor liquefaction, but did not decrease tumor size. Intratumoral (32)P was associated with more serious adverse events and did not improve survival for locally advanced unresectable pancreatic cancer.