Evaluation of custom-made Relay® stent-grafts for aortic arch landing zones 0 and I: experience from two high-volume aortic centres.

OBJECTIVES: To report experience with a Relay® stent-graft custom-made platform in treating different aortic arch pathology in 2 high-volume aortic centres. METHODS: A retrospective analysis of all patients treated between July 2016 and July 2023 with custom-made Relay® stent-graft (custom-made device). Underlying aortic arch pathology was an aneurysm, penetrating aortic ulcer, and dissection. Three custom-made device designs were used: proximal scallop, fenestrations, and inner branches. The endpoints were technical success, perioperative stroke, death, and reintervention rate. RESULTS: Thirty-five patients (89% males) with a mean age of 70 ± 11 years were treated.Indication for treatment was penetrating aortic ulcer in 14 patients (40%), aneurysm in 11 patients (31%) and aortic dissection in 10 patients (29%). The technical success rate was 100%. Twenty-eight patients (80%) had proximal sealing in zone 0, and 7 (20%) had proximal sealing in zone 1. Nine patients (25.6%) had proximal scallops, 9 (25.6%) had 1 big fenestration and 17 (48.8%) had a branched device; 1 with single branch, 15 with double branches and 1 with triple branches. Thirty patients (86%) had previous or simultaneous left subclavian artery revascularization. No patient died during 30 days. Two patients (5.7%) had stroke postoperatively; both recovered without disabling deficits. The mean follow-up was 35 ± 26 months. Six patients (17.1%) died during follow-up. One patient required reinforcement of the bridging stent in the left common carotid artery and one additional vascular plugging of the left subclavian artery. Three patients received distal extension. CONCLUSIONS: The Relay® stent-graft custom-made platform showed a good performance in our study with a high technical success rate, low perioperative stroke and mortality, and low reintervention rates during the follow-up.

A combined endovascular and open repair of innominate artery bifurcation pseudoaneurysm: a case report.

BACKGROUND: Innominate artery aneurysms (IAAs) are rare and may result in rupture, distal arterial embolization, or local compression without timely treatment. Rupture is the most dangerous of these complications. This article reports a case of innominate artery bifurcation pseudoaneurysm. CASE PRESENTATION: The patient was a 45-year-old man who was admitted to the emergency department due to chest discomfort. The computed tomographic angiography (CTA) imaging indicated the presence of a 3.6*2.4 cm saccular aneurysm in the bifurcation of the innominate artery, involving both the right proximal subclavian and common carotid arteries. The patient's vital signs were normal, there was equal blood pressure in the upper arms and no neurological dysfunction was observed. Gadolinium-enhanced magnetic resonance angiography indicated that the circle of Willis was intact. The treatment involved open surgery combined with endovascular therapy. The external carotid artery was first transposed to the right subclavian artery (RSA) and an 8-mm woven Dacron graft was inserted in the middle. The covered stent graft was then placed in the proximal part of the innominate artery to close the entrance of the aneurysm. Lastly, an occluder was implanted at the origin of the RSA. There were no perioperative or postoperative complications. At 1-year follow-up, no aneurysm was observed on CTA and the right vertebral artery was patent. CONCLUSIONS: This study indicated that the combined use of endovascular therapy and open repair surgery is an effective strategy to treat innominate artery bifurcation pseudoaneurysm.

Retrospective evaluation of three types of expanded polytetrafluoroethylene grafts for upper limb vascular access.

Currently, three expanded polytetrafluoroethylene (ePTFE) prosthetic graft types are most commonly used for patients with end-stage kidney disease (ESKD) who require long-term vascular access for hemodialysis. However, studies comparing the three ePTFE grafts are limited. This study compared the clinical efficacy and postoperative complications of three ePTFE prosthetic graft types used for upper limb arteriovenous graft (AVG) surgery among patients with ESKD. Patients with ESKD requiring upper limb AVG surgery admitted to our center between January 2016 and September 2019 were enrolled. Overall, 282 patients who completed the 2-year follow-up were included and classified into the following three groups according to the ePTFE graft type: the GPVG group with the PROPATEN® graft, the GAVG group with the straight-type GORE® ACUSEAL, and the BVVG group with the VENAFLO® II. The patency rate and incidence of access-related complications were analyzed and compared between groups. The patients were followed up postoperatively, and data were collected at 6, 12, 18, and 24 months postoperatively. Respective to these follow-up time points, in the GPVG group, the primary patency rates were 74.29%, 65.71%, 51.43%, and 42.86%; the assisted primary patency rates were 85.71%, 74.29%, 60.00%, and 48.57%; and the secondary patency rates were 85.71%, 80.00%, 71.43%, and 60.00%. In the GAVG group, the primary patency rates were 73.03%, 53.93%, 59.42%, and 38.20%; the assisted primary patency rates were 83.15%, 68.54%, 59.55%, and 53.93%; and the secondary patency rates were 85.39%, 77.53%, 68.54%, and 62.92%, respectively. In the BVVG group, the primary patency rates were 67.24%, 53.45%, 41.38%, and 29.31%; the assisted primary patency rates were 84.48%, 67.24%, 55.17%, and 44.83%; and the secondary patency rates were 86.21%, 81.03%, 68.97%, and 60.34%, respectively. The differences in patency rates across the three grafts were not statistically significant. Overall, 18, 4, and 12 patients in the GPVG, GAVG, and BVVG groups, respectively, experienced seroma. Among the three grafts, GORE® ACUSEAL had the shortest anastomosis hemostatic time. The first cannulation times for the three grafts were GPVG at 16 (±8.2), GAVG at 4 (±4.9), and BVVG at 18 (±12.7) days. No significant difference was found in the postoperative swelling rate between the GPVG group and the other two groups. Furthermore, no statistically significant differences were found across the three graft types regarding postoperative vascular access stenosis and thrombosis, ischemic steal syndrome, pseudoaneurysm, or infection. In conclusion, no statistically significant differences in the postoperative primary, assisted primary, or secondary graft patency rates were observed among the three groups. A shorter anastomosis hemostatic time, first cannulation time, and seroma occurrence were observed with the ACUSEAL® graft than with its counterparts. The incidence of upper extremity swelling postoperatively was greater with the PROPATEN® graft than with the other grafts. No statistically significant differences were observed among the three grafts regarding the remaining complications.

Repair of Dissecting Aortic Aneurysm in Post-LVAD Patient.

Left ventricular assist devices (LVAD) are frequently used in the management of end-stage heart failure, especially given the limited availability of donor hearts. The latest HeartMate 3 LVAD delivers non-physiological continuous flow (CF), although the impact on the aorta is not well established. We highlight a case of aortic aneurysm formation complicated by dissection formation that necessitated high-risk re-operative surgery in a patient post CF-LVAD.

Short-term outcomes of endovascular aortic aneurysm repair with the new Braile Biomédica® total custom-made abdominal endograft: Experience from three Italian centers.

INTRODUCTION: Since 2019, Braile Biomédica® introduced a novel custom-made abdominal endograft tailored to the aorta's anatomy, featuring sizing every 3 mm and a diameter change from 50 mm to 8 mm. This design permits uncovered fenestrations around a single Z stent, eliminating the need for bridging stents to visceral vessels. Utilizing triple stent technology, optimal neck fixation is ensured, enabling treatment of necks shorter than 2 mm, with three 360° fenestrations optimizing graft fixation. This paper aims to analyze the initial experience with this custom-made infrarenal graft for abdominal aorta aneurysm (AAA), concerning procedural success and post-procedural short-term outcomes. RESULTS: Among 12 patients treated from May 2022 to January 2024, technical success was achieved in 91.7 %, with only one intra-procedural complication. Follow-up CT scans at 1-3 months revealed resolution of an intraoperative endoleak and two late complications: a late type III endoleak and right renal artery occlusion. CONCLUSIONS: The recent experience with Braile Biomédica® custom-made abdominal endograft demonstrates promising outcomes, particularly in treating AAAs with challenging anatomical features.

Disappointing results of popliteal aneurysm endovascular treatment with a new self-expandable covered stent.

PURPOSE: To describe our clinical experience of endovascular exclusion of popliteal artery aneurysms using the new self-expandable covered stent SOLARIS® (Scitech Medical, Brazil), and to report its results in the context of surgical and endovascular treatment of popliteal artery aneurysms. CASE REPORT: Among 20 popliteal artery aneurysms undergoing open or endovascular repair in 2022 and 2023, two patients were successfully treated with the Solaris stentgraft. Both patients had a patent popliteal artery and three run-off vessels. After stentgraft implantation, they received dual antiplatelet therapy for three months and they were followed-up with Duplex scan and clinical evaluation after three months, and every six months thereafter. After three months, one Solaris stentgraft had complete thrombosis and the other ruptured, requiring surgical removal. No complications were observed among the other aneurysms treated with open repair or with the Viabahn® stentgraft. CONCLUSIONS: Endovascular treatment of popliteal aneurysms with the new covered self-expandable stent Solaris resulted in severe complications in the two cases reported, and in worse short-term outcomes than endovascular repair with Viabahn® and open repair. Its off-label use to treat popliteal artery aneurysms should be therefore discouraged.

Midterm outcomes of "wide neck" abdominal aortic aneurysm after open or endovascular repair in two European centers: a propensity score matching analysis.

BACKGROUND: The aim of this study was to compare mid-term clinical and morphological outcomes in patients undergoing open (OR) and endovascular aortic repair (EVAR) with a proximal wide neck abdominal aortic aneurysm (WN-AAA). METHODS: Between 2009 and 2014 data of all patients undergoing OR at IRCCS San Raffaele Hospital and EVAR at German Aortic Center Hamburg were retrospectively analyzed. Primary endpoints were aneurysm-related mortality at 5 years, reintervention, and overall mortality. Secondary endpoint was proximal neck enlargement. A 1:1 propensity score matching (PSM) was performed. Survival and freedom from AAA-related reintervention were investigated in matched OR and EVAR group by Kaplan-Meier analysis. RESULTS: Of all OR performed at IRCCS San Raffaele Hospital 70 were found to have a proximal neck >28 mm (mean age: 69.8±7.2 years, 67 [95.71%] male); of all consecutive EVAR performed at German Aortic Center Hamburg, 52 required an endograft size of at least 32 mm (mean age of 73.1±8.7 years, 49 [94.2%] male). After PSM, the study cohort consisted of 30 OR and EVAR. One early mortality was registered in both groups (P=NS). Mid-term freedom from reintervention compared in OR and EVAR, with no statistically significant differences (P=0.979). Eight (15.4%) patients treated with EVAR developed a significant proximal diameter enlargement (≥3 mm) while only 1 (1.4%) patient in the OR group had the same evolution (P<0.01). CONCLUSIONS: In WN-AAA neck enlargement is observed more frequently in patients undergoing EVAR, but reintervention rate was similar in the 2 groups, demonstrating that both options were safe and effective.

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.

Harnessing the potential of monocytes/macrophages to regenerate tissue-engineered vascular grafts.

Cell-free tissue-engineered vascular grafts provide a promising alternative to treat cardiovascular disease, but timely endothelialization is essential for ensuring patency and proper functioning post-implantation. Recent studies from our lab showed that blood cells like monocytes (MCs) and macrophages (Mϕ) may contribute directly to cellularization and regeneration of bioengineered arteries in small and large animal models. While MCs and Mϕ are leucocytes that are part of the innate immune response, they share common developmental origins with endothelial cells (ECs) and are known to play crucial roles during vessel formation (angiogenesis) and vessel repair after inflammation/injury. They are highly plastic cells that polarize into pro-inflammatory and anti-inflammatory phenotypes upon exposure to cytokines and differentiate into other cell types, including EC-like cells, in the presence of appropriate chemical and mechanical stimuli. This review focuses on the developmental origins of MCs and ECs; the role of MCs and Mϕ in vessel repair/regeneration during inflammation/injury; and the role of chemical signalling and mechanical forces in Mϕ inflammation that mediates vascular graft regeneration. We postulate that comprehensive understanding of these mechanisms will better inform the development of strategies to coax MCs/Mϕ into endothelializing the lumen and regenerate the smooth muscle layers of cell-free bioengineered arteries and veins that are designed to treat cardiovascular diseases and perhaps the native vasculature as well.

Clinical Outcome of the Type A Acute Aortic Dissection Repair Using the "Tailored Stand-Up Collar" Technique.

PURPOSE: Achieving a secure anastomosis and complete hemostasis is essential for surgically treating type A acute aortic dissection (TAAAD). This study assessed the clinical feasibility of "tailored stand-up collar (TSC)" technique for constructing the distal stump. METHODS: We enrolled 68 patients who underwent ascending aortic repair for TAAAD. Patients were categorized according to the technique for distal stump construction: conventional (C) group using only a felt strip (32 cases); post-aortotomy (P) group, with a Hydrofit-felt strip attached after aortotomy (18 cases), and TSC group, where a Hydrofit-felt strip attached during cooling (18 cases). Pre-operative characteristics, procedural profiles, and post-operative outcomes were evaluated. RESULTS: The pre-operative characteristics were identical among the groups. The durations of cardiopulmonary bypass, hemostasis, and surgery were significantly shorter in the P and TSC groups. The duration of open distal in the TSC group (21 min) was significantly shorter than the other two groups. Post-operative additional procedures were not required for the TSC group and their post-operative hospital stay was significantly shorter (47.1% of patients were discharged within 2 weeks). CONCLUSION: The TSC technique would be practical because of its high reproducibility in terms of ease of use, shorter anastomotic time, and secure hemostasis.

Use of EndoAnchors during index endovascular aortic aneurysm repair in patients with hostile proximal aortic neck anatomy.

PURPOSE: Standard endovascular aortic aneurysm repair (EVAR) is sometimes the only treatment option for patients with hostile aortic neck anatomy, but it carries an increased risk of both early and late procedure-related complications. The aim of this study was to report on single-center experience with the Heli-FX EndoAnchors (Medtronic, Santa Rosa, CA) as an adjunctive procedure to endovascular aneurysm repair (EVAR) for prevention and perioperative treatment of proximal neck complications in patients with hostile neck anatomy.  MATERIALS AND METHODS: A single-centre, retrospective study evaluating 24 consecutive patients treated with EndoAnchors during the index EVAR procedure between November 2018 and August 2021. EndoAnchor implantation was indicated for cases with hostile proximal aortic neck anatomy characterised by the presence of at least one of the following parameters: length of 28 mm, angle of >60°, circumferential thrombus/calcification involving ≥50%, and reverse taper. RESULTS:  Median follow-up period was 22.5 months (IQR 2-31.5 months) with no aneurysm-related death, rupture, or conversion to open surgical repair during the follow-up. The procedural success rate was 100%, with no type Ia endoleak at the completion angiography. A mean of 7 EndoAnchors was used per patient (range 4-12). There were no EndoAnchor fractures and dislocations or stent graft fabric damage due to anchor implants. Twenty-three patients (95.8%) remained free of type Ia endoleak and migration on follow-up imaging. Aneurysm sac regression was observed in 13 patients (54.1%), while in 8 patients (33.3%) the sac remained stable. Sac enlargement was present in 1 patient (4.2%) due to late type Ia endoleak. Two patients were lost to the follow-up immediately after the procedure. Between two groups of patients (sac regression versus failure to regress), the larger initial diameter of the proximal neck was the only significant independent factor associated with a lower possibility of sac regression (p= 0,021). CONCLUSIONS:  The use of EndoAnchors during the index EVAR procedure in cases with challenging aortic neck anatomy with or without perioperative type Ia endoleak was associated with good midterm results and led to sac regression in most of the patients (Tab. 4, Fig. 3, Ref. 31).

NASCI case of the month: extensive ascending aortic graft infection with underlying chronic sternal osteomyelitis-a rare and high-risk complication.

Thoracic aortic graft infections are infrequent yet grave complications of cardiovascular surgery. Risk factors include prolonged operative time, postoperative wound infections, and patient-specific risk factors like diabetes or malnutrition (Van Hemelrijck et al., Vessel Plus 6:47, 2022). In postoperative vascular scenarios, it is critical to utilize cross-sectional imaging to detect the presence of a complication, followed by describing the morphology, extent, and ancillary features. FDG-PET/CT can help differentiate between expected postoperative changes and worrisome infection by metabolic activity (FDG uptake). We present an extensive case of ascending aortic graft infection in the setting of ongoing sternal osteomyelitis. CT and PET/CT reveal chronic sternal osteomyelitic changes spreading into the retrosternal soft tissues, and a large intraluminal thrombus in the ascending aortic graft. Small mobile strands propagate toward the right brachiocephalic origin, posing a significant stroke risk. PET/CT confirmed postoperative infection by demonstrating increased FDG uptake.

Analysis of Aortic Arch Hemodynamics With Simulated Bird's Beak Effects.

OBJECTIVE: The objective of this study was to investigate the flow effects in different degrees of thoracic aortic stent graft protrusion extension by creating bird beak effect simulations using accurate 3D geometry and a realistic, nonlinear, elastic biomechanical model using computer-aided software SolidWorks. METHODS: Segmentation in 3D of an aortic arch from a computed tomography (CT) scan of a real-life patient was performed using SolidWorks. A parametric analysis of three models was performed: (A) Aortic arch with no stent, (B) 3 mm bird-beak configuration, and (C) 6.5 mm bird-beak configuration. Flow velocity, pressure, vorticity, wall shear stress (WSS), and time average WSS were assessed. RESULTS: The flow velocity in Model A remained relatively constant and low in the area of the ostium of the brachiocephalic artery and doubled in the left subclavian artery. On the contrary, Models B and C showed a decrease in velocity of 52.3 % in the left subclavian artery. Furthermore, Model B showed a drop in velocity of 82.7% below the bird-beak area, whereas Model C showed a decline of 80.9% in this area. The pressure inside the supra-aortic branches was higher in Model B and C compared with Model A. In Model A, vorticity only appeared at the level of the descending aorta, with low to non-vorticity in the aortic arch. In contrast, Models B and C had an average vorticity of 241.4 Hz within the bird beak area. Regarding WSS, Model A, and Model B shared similar WSS in the peak systolic phase, in the aortic arch, and the bird beak area, whereas Model C had an increased WSS by 5 Pa on average at these zones. CONCLUSION: In the present simulations' lower velocities, higher pressures, vortices, and WSS were observed around the bird beak zone, the aortic arch, and the supra-aortic vessels.

Early Financial Outcomes of Physician Modified Endograft Programs Are Dictated by Device Cost.

INTRODUCTION: Physician-modified endografts (PMEGs) have been used for repair of thoracoabdominal aortic aneurysms (TAAAs) for 2 decades with good outcomes but limited financial data. This study compared the financial and clinical outcomes of PMEGs to the Cook Zenith-Fenestrated (ZFEN) graft and open surgical repair (OSR). METHODS: A retrospective review of financial and clinical data was performed for all patients who underwent endovascular or OSR of juxtarenal aortic aneurysms and TAAAs from January 2018 to December 2022 at an academic medical center. Clinical presentation, demographics, operative details, and outcomes were reviewed. Financial data was obtained through the institution's finance department. The primary end point was contribution margin (CM). RESULTS: Thirty patients met inclusion criteria, consisting of twelve PMEG, seven ZFEN, and eleven open repairs. PMEG repairs had a total CM of -$110,000 compared to $18,000 for ZFEN and $290,000 for OSR. Aortic and branch artery implants were major cost-drivers for endovascular procedures. Extent II TAAA repairs were the costliest PMEG procedure, with a total device cost of $59,000 per case. PMEG repairs had 30-d and 1-y mortality rates of 8.3% which was not significantly different from ZFEN (0.0%, P = 0.46; 0.0%, P = 0.46) or OSR (9.1%, P = 0.95; 18%, P = 0.51). Average intensive care unit and hospital stay after PMEG repairs were comparable to ZFEN and shorter than OSR. CONCLUSIONS: Our study suggests that PMEG repairs yield a negative CM. To make these cases financially viable for hospital systems, device costs will need to be reduced or reimbursement rates increased by approximately $8800.

Latest evidence on chimney endovascular repair of abdominal aortic aneurysms and the renal artery angulation pitfall.

This article summarizes the key findings in literature up to date on the endovascular treatment of complex abdominal aortic aneurysms (AAAs) employing the chimney technique. Additionally, an unexplored pitfall is described regarding the target vessel angulation. Although balloon-expandable covered stents present more favorable configuration in downward-oriented target vessels, transverse and upward-oriented target vessels may benefit from other endovascular techniques imploring careful case planning and further investigation on the topic.

Physician-modified versus chimney endografting for pararenal aortic aneurysms: a systematic review and meta-analysis.

INTRODUCTION: We performed a systematic review and meta-analysis to assess the existing published evidence regarding the safety and efficacy of the endovascular aortic repair with chimney technique (ch-EVAR) and physician-modified stent-grafts (PMSGs) for the treatment of pararenal aortic aneurysm repair. EVIDENCE ACQUISITION: A systematic search of all relevant studies reported until October 2023 according to the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines was performed. The pooled 30-day mortality, peri- and postoperative complication rates were estimated using fixed or random effect methods. EVIDENCE SYNTHESIS: A total of 679 study titles were identified by the initial search strategy, of which 16 were considered eligible for inclusion in the meta-analysis. A total of 1094 patients (ch-EVAR N.=861 and PMSG N.=233) (90% male) were identified. The pooled 30-day mortality rate was 3.4% for ch-EVAR and 2.6% for PMSG. The major adverse events (MAE) in the early period was 14.7% for ch-EVAR and 18.5% PMSG, respectively. Higher occlusion rate was observed of the chimney stents grafts (8.2%) than the bridging stents (1.4%) during the follow-up period. CONCLUSIONS: Ch-EVAR and physician-modified technology are safe with low 30-day mortality in elective settings for pararenal aortic aneurysms repair. No significant differences were seen between the two surgical methods regarding the early major adverse events rate. However, higher occlusion rate for the chimneys can be expected over time.