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.

Three-year outcomes of contemporary endovascular treatment in over 25-cm femoropopliteal artery disease from a retrospective multicenter registry: A retrospective observational study.

BACKGROUND: Endovascular therapy (EVT) is often performed for diffuse femoropopliteal lesions. This study investigated 3-year patency and clinical outcomes in patients with EVT-treated femoropopliteal lesions >25 cm. METHODS: This retrospective multicenter registry analyzed patients who presented with lower extremity artery disease having femoropopliteal lesions >25 cm who underwent EVT between 2017 and 2021. The primary outcome was restenosis 3 years after EVT. RESULTS: Overall, 504 patients with 614 lesions undergoing EVT for diffuse femoropopliteal lesions were enrolled. The prevalence of restenosis was 184.3 per 1000 lesion-years. Kaplan-Meier estimate of freedom from restenosis was 58.6% at 3 years. In the multivariate Poisson regression model, female sex (adjusted incidence risk ratio: 1.54; p = 0.003), cilostazol use (0.44; p < 0.001), revascularization history (1.87; p = 0.001), P3 involvement (2.09; p < 0.001), and reference vessel diameter <5 mm (1.88; p < 0.001) were associated independently with restenosis risk. The accumulation of these factors was associated with a lower rate of freedom from restenosis; the Kaplan-Meier estimates of the rates were 49.3% and 22.4% in the subgroups with two and more risk factors, respectively, while they were 81.1% in patients without any risk factors and 70.3% in those with one risk factor. CONCLUSIONS: Female sex, nonuse of cilostazol, revascularization history, P3 involvement, and small vessels were associated with high restenosis risk after EVT for diffuse femoropopliteal lesions. Although patients with multiple risk factors have a low patency rate, EVT offers an acceptable patency rate for those with fewer risk factors.

Five-year outcomes from a prospective, multicenter study of endovascular repair of iliac artery aneurysms using an iliac branch device.

OBJECTIVE: We have reported the 5-year results of a pivotal prospective, multicenter study conducted in the United States of a specifically designed iliac branch endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, AZ) for endovascular repair of aortoiliac aneurysms and common iliac artery aneurysms. METHODS: A total of 63 patients (98.4% male; mean age, 70 years) with aortoiliac or common iliac artery aneurysms had undergone implantation of a single IBE device and a bifurcated aortoiliac stent graft. Patients with bilateral common iliac artery aneurysms (n = 22; 34.9%) had undergone either staged occlusion or surgical revascularization of the contralateral internal iliac artery before study enrollment. At 5 years, 36 of the 63 patients had completed the final study follow-up examinations, including clinical examinations (n = 35) and computed tomography (n = 32), with the results evaluated by an independent core laboratory and adverse events adjudicated by a clinical events committee. RESULTS: At 5 years, freedom from all-cause mortality was 85.7% and freedom from aneurysm-related mortality was 100%. The nine deaths that had occurred (range, 132-1898 days) were adjudicated as unrelated to the aneurysm or procedure. Primary patency of the internal and external iliac artery IBE limbs was 95.1% and 100%, respectively. No patients had experienced new-onset buttock claudication on the IBE side or self-reported new-onset erectile dysfunction. The common iliac artery diameter on the IBE side was either unchanged or had decreased by ≥5 mm in 30 of the 31 patients (96.8%) with a baseline (1 month) and 5-year (range, 1641-2006 days) computed tomography scan available. Of the 31 evaluable patients, 9 (29.0%) had had an increase of ≥5 mm in the aortic diameter, 5 of whom had had a concurrent type II endoleak. No type I or type III endoleaks or device migration were identified by the core laboratory. Six patients had undergone eight secondary interventions, including five interventions for a type II endoleak. The freedom from secondary intervention was 90.5%. CONCLUSIONS: The 5-year results of our prospective, multicenter study have confirmed the safety, efficacy, and durability of the IBE device for the treatment of aortoiliac and iliac artery aneurysms. The device effectively prevented common iliac artery aneurysm rupture, maintained the patency of the internal iliac artery, and avoided the complications associated with internal iliac artery sacrifice. Although common iliac artery aneurysm enlargement was rare, abdominal aortic enlargement was more common, suggesting that the outcomes of endovascular aneurysm repair might be different for patients with or without associated common iliac artery aneurysms.

Clinical outcomes of polymer-free, paclitaxel-coated stents vs stent grafts in peripheral arterial disease patients with femoropopliteal artery lesions.

OBJECTIVE: Zilver PTX polymer-free, paclitaxel-coated stents and Viabahn stent grafts are effective for the treatment of femoropopliteal lesions. The aim of this study was to compare clinical outcomes between the two devices in patients with symptomatic peripheral arterial disease in real-world settings. METHODS: This multicenter, retrospective study concerned a clinical database of 445 patients with symptomatic peripheral arterial disease (Rutherford categories 1-6) who underwent either Zilver PTX or Viabahn implantation for a femoropopliteal lesion of 10 cm or longer with reference vessel diameters of 4.0 to 7.5 mm between 2012 and 2018 at five hospitals in Japan. Outcome measures were primary patency, freedom from stent thrombosis, freedom from any target lesion reintervention, limb salvage, and overall survival. After propensity score matching, these clinical outcomes were compared between patients treated with the Zilver PTX and those treated with the Viabahn. Also assessed were the interaction effects of baseline characteristics on the association of the Zilver PTX and Viabahn with restenosis and stent thrombosis. RESULTS: In total, 271 patients were treated with the Zilver PTX, and 174 patients were treated with the Viabahn. Propensity score matching extracted 133 patient pairs with no major intergroup differences in baseline characteristics. The Zilver PTX group had a lower rate of 3-year primary patency (59.5%; [95% confidence interval (CI), 53.0%-66.2%] vs 69.6% [95% CI, 59.3%-79.4%]; P = .005), but a higher rate of 3-year freedom from stent thrombosis (93.6% [95% CI, 90.0%-96.3%] vs 82.4% [95% CI, 74.5%-89.0%], P = .038). There was no significant difference in overall survival, limb salvage, or freedom from reintervention (all P > .05). An interaction analysis showed that the restenosis risk of the Zilver PTX was significantly higher vs the Viabahn in patients with no or one below-the-knee runoff vessel and in those with intravascular ultrasound use than in patients with two or three below-the-knee runoff vessels and in those without intravascular ultrasound use, respectively (P for interaction = .046 and .010, respectively), whereas the stent thrombosis risk of the Zilver PTX was significantly smaller vs the Viabahn in patients not on dialysis than in those on dialysis (P for interaction = .034). CONCLUSIONS: Compared with Viabahn stent grafts, Zilver PTX stents have a lower rate of primary patency but a higher rate of freedom from stent thrombosis.

Retrospective multicenter registry for endovascular treatment with newer devices in over 25-cm femoropopliteal artery disease: A retrospective observational study.

Background and Aims: Endovascular therapy (EVT) is recommended in femoropopliteal (FP) lesions shorter than 25 cm by current guidelines; however, diffuse FP lesions remains challenging for EVT. The aim of this study was to investigate the efficacy of EVT with the latest devices for FP lesions longer than 25 cm. Methods: This retrospective multicenter registry analyzed patients presented peripheral artery disease (PAD) having FP lesions longer than 25 cm who underwent EVT using the latest devices between 2017 and 2021. The primary outcome was restenosis 1 year after EVT. Results: The present study enrolled a total of 504 PAD patients with 614 lesions undergoing EVT for diffuse FP lesions. The Kaplan-Meier analysis showed that the rates of freedom from restenosis and clinically-driven target lesion revascularization were 79.3% and 82.4% 1 year after EVT, respectively. The multivariate Cox proportional hazards regression analysis showed that clinical features associated independently with restenosis risk were cilostazol use (adjusted hazard ratio, 0.49 [0.32-0.74]; p = 0.001), reference vessel diameter (RVD) (0.72 [0.58-0.89] per 1-mm increase; p = 0.002), and P3 segment involvement (2.08 [1.33-3.26]; p = 0.001). The Kaplan-Meier analysis was conducted to compare the primary patency between cases with and without a small RVD, P3 involvement, and/or lack of cilostazol; any risk factors were related to a worse primary patency rate, compared with cases without risk factors. Conclusion: In the current EVT era, the primary patency at 1 year was acceptable at 79.3% in patients with FP lesions longer than 25 cm. A small vessel and P3 segment involvement might be associated with a poor 1-year patency rate after EVT, whereas cilostazol administration might contribute to reducing restenosis.

Infrarenal Remains Infrarenal-EVAR Suitability of Small AAA Is Rarely Compromised despite Morphological Changes during Surveillance.

The aim was to analyze small abdominal aortic aneurysm (AAA) morphology during surveillance with regard to standard endovascular aortic repair (EVAR) suitability. This retrospective single-center study included all patients (n = 52, 48 male, 70 ± 8 years) with asymptomatic AAA ≤ 5.4 cm undergoing ≥2 computed tomography angiography(CTA)/magnetic resonance imaging (MRI) studies (interval: ≥6 months) between 2010 and 2018. Aneurysm diameter, neck quality (shape, length, angulation, thrombus/calcification), aneurysm thrombus, and distal landing zone diameters were compared between first and last CTA/MRI. Resulting treatment plan changes were determined. Neck shortening occurred in 25 AAA (mean rate: 2.0 ± 4.2 mm/year). Neck thrombus, present in 31 patients initially, increased in 16. Average AAA diameters were 47.7 ± 9.3 mm and 56.3 ± 11.6 mm on first and last CTA/MRI, mean aneurysm growth rate was 4.2 mm/year. Aneurysm thrombus was present in 46 patients primarily, increasing in 32. Neck thrombus growth and neck length change, aneurysm thrombus amount and aneurysm growth and aneurysm growth and neck angulation were significantly correlated. A total of 46 (88%) patients underwent open (12/46) or endovascular (34/46) surgery. The planned procedure changed from EVAR to fenestrated EVAR in two patients and from double to triple fenestrated EVAR in one. Thus, standard EVAR suitability was predominantly maintained as the threshold diameter for surgery was reached despite morphological changes. Consecutively, a possibly different pathogenesis of infra- versus suprarenal AAA merits further investigation.

The Effect of Abdominal Aortic Aneurysm Size on Endoleak, Secondary Intervention and Overall Survival Following Endovascular Aortic Aneurysm Repair.

OBJECTIVE: The purpose of this study was to identify the effect of abdominal aortic aneurysm (AAA) size on endoleak development and secondary intervention after endovascular repair (EVAR), as well as to examine the effect on overall survival and cause of mortality. METHODS: Retrospective analysis was performed on all non-ruptured AAA treated by elective EVAR using FDA-approved endografts in our facility from July 2004 to December 2017. Patients were grouped into 3 cohorts based on preoperative aneurysm size: Group I (<5.5 cm), Group II (5.5-6.4 cm), and Group III (≥ 6.5 cm). Occurrences of endoleak, secondary intervention and overall survival underwent univariate and multivariate analysis. Cause of death data on deceased patients was similarly examined. RESULTS: A total of 517 patients were analyzed. There was no difference between size groups in the rate of endoleak (Group I 48/277, 17.3%; Group II 33/160, 20.6%; Group III 18/80, 22.5%; p = 0.46) or time until endoleak development. Univariate analysis showed no difference in the rate of secondary intervention (Group I 36/277, 13.0%; Group II 24/160, 15.0%; Group III 18/80, 22.5%; p = 0.11), time until intervention or number of interventions performed. Multivariate analysis showed an association with shorter time to secondary intervention for both Group III aneurysms (HR 2.03, 95% CI 1.11-3.73; p = 0.02) and female patients (HR 1.79, 95% CI 1.02-3.13; p = 0.04). There was no difference in overall survival, aneurysm-related mortality or overall cause of mortality. CONCLUSION: AAA diameter prior to EVAR was not associated with any differences in rates of endoleak or secondary intervention, and was not associated with poorer overall survival or greater aneurysm-related mortality. Patients with suitable anatomy for EVAR can be considered for this intervention without concern for increased complications or poorer outcomes related to large aneurysm diameter alone.

Paraplegic neurodeficit management post endovascular graft: a rare case of aortic dissection.

Acute aortic dissection is a catastrophic episode that usually presents as a sudden, painful, ripping sensation in the chest or back. It is associated with neurologic sequelae in as many as one-third of patients. We report a case of aortic dissection, presenting as acute paraplegia. A 50-year-old patient presented to us with chief complaints of paraplegia and back pain. On examination, strength was 5/5 in both upper extremities and 0/5 in both lower extremities. Deep tendon reflexes were absent in her legs. CT angiogram of aorta Aortic Dissection Stanford type B / De-Bakey type -III. Patient was treated with endovascular graft for aortic dissection, paraplegia recovered completely.