Search

Objectives: The optimal bridging stent for fenestrations during complex endovascular aortic aneurysm repair (EVAR) has not been defined. At our institution, the Viabahn VBX is frequently used given its availability and mechanical and heparin-bonding characteristics. This study aimed to assess the performance of the Viabahn VBX vs the iCast balloon-expandable covered stents as bridging stents for fenestrations during complex EVAR., Methods: A retrospective study of consecutive patients undergoing complex EVAR between 2015 and 2021 was performed. Celiac arteries (CAs), superior mesenteric arteries (SMAs), left renal arteries, and right renal arteries stented with fenestrations were grouped according to the type of bridging stent, VBX vs iCast. Target vessels (TV) stented with a branch or scallop were excluded. The primary end points included primary patency and freedom from TV instability., Results: A total of 292 patients undergoing complex EVAR were treated using VBX or iCast with a mean follow-up of 190 days (interquartile range, 36-384 days) for the VBX cohort and 804 days (interquartile range, 384-1507 days) for the iCast cohort. A total of 677 TVs were stented, including 134 CAs (20%), 175 SMAs (26%), 182 left RAs (27%), 186 right RAs (27%), and 12 additional vessels (2%). Proximal reinforcement was more frequent with VBX than with iCast stent (23% vs 2.4%; P < .0001). There was no difference in primary patency rates at 2 years between VBX and iCast stent for CA (100% vs 96.4%; P = .32), SMA (97.8% vs 100%; P = .14), and the RAs (96.7% vs 99.4%; P = .11). There was no difference between VBX and iCast in the cumulative incidence of type Ic and type IIIc endoleaks (3.2% vs 5.6%; P = .69) or freedom from TV instability at 2 years., Conclusions: Viabahn VBX stents are a safe and effective option as bridging stents in fenestrations during complex EVAR with comparable midterm outcomes to iCast stents. However, proximal stent reinforcement may be required with VBX stent to ensure adequate sealing at the fenestrations. Longer follow-ups and larger series are required to assess long-term outcomes and durability., Competing Interests: Disclosures M.S.B. and C.H.T. have been consultants for and received research support from Cook Medical Inc, W. L. Gore & Associates, Inc., and Phillips Healthcare. M.K. has been consultant for W. L. Gore & Associates, Inc., (Copyright © 2024. Published by Elsevier Inc.)

Objectives: Aneurysm sac changes after fenestrated-branched endovascular aneurysm repair (FBEVAR) for postdissection thoracoabdominal aortic aneurysms (PD-TAAs) are poorly understood. Partial thrombosis of the false lumen and endoleaks may impair sac regression. To characterize sac changes after FBEVAR for PD-TAAs, this study examined midterm results and predictors for sac enlargement., Methods: FBEVARs performed for PD-TAAs in 10 physician-sponsored investigational device exemption studies from 2008 to 2023 were analyzed. The maximum aortic aneurysm diameter was compared between the 30-day computed tomography angiogram and follow-up imaging studies. Aneurysm sac enlargement was defined as an increase in diameter of ≥5 mm. Kaplan-Meier curves and Cox regression were used to evaluate sac enlargement and midterm FBEVAR outcomes., Results: Among 3296 FBEVARs, 290 patients (72.4% male; median age, 68.4 years) were treated for PD-TAAs. Most aneurysms treated were extent II (72%) and III (12%). Mean aneurysm diameter was 66.5 ± 11.2 mm. Mortality at 30 days was 1.4%. At a mean follow-up of 2.9 ± 1.9 years, at least one follow-up imaging study revealed sac enlargement in 43 patients (15%), sac regression in 115 patients (40%), and neither enlargement nor regression in 137 (47%); 5 (2%) demonstrated both expansion and regression during follow-up. Freedom from aneurysm sac enlargement was 93%, 82%, and 80% at 1, 3, and 5 years, respectively. Overall, endoleaks were detected in 27 patients (63%) with sac enlargement and 143 patients (58%) without enlargement (P = .54). Sac enlargement was significantly more frequent among older patients (mean age at the index procedure, 70.2 ± 8.9 years vs 66.5 ± 11 years; P = .04) and those with type II endoleaks at 1 year (74% vs 52%; P = .031). Cox regression revealed age >70 years at baseline (hazard ratio [HR], 2.146; 95% confidence interval [CI], 1.167-3.944; P = .010) and presence of type II endoleak at 1 year (HR, 2.25; 95% CI, 1.07-4.79; P = .032) were independent predictors of sac enlargement. Patient survival was 92%, 81%, and 68% at 1, 3, and 5 years, respectively. Cumulative target vessel instability was 7%, and aneurysm-related mortality was 2% at 5 years. At least 42% of patients required secondary interventions. Sac enlargement did not affect patient survival., Conclusions: Aneurysm sac enlargement occurs in 15% of patients after FBEVAR for PD-TAAs. Elderly patients (>70 years at baseline) and those with type II endoleaks at 1 year may need closer monitoring and secondary interventions to prevent sac enlargement. Despite sac enlargement in some patients, aneurysm-related mortality at 5 years remains low and overall survival was not associated with sac enlargement., Competing Interests: Disclosures A.W.B has been a consultant for Artivion Inc., Cook Medical Inc., Philips Healthcare, and Terumo Cardiovascular Group and received research support from Cook Medical Inc, Endospan Ltd, Medtronic PLC, Philips Healthcare, Terumo Cardiovascular Group, and W. L. Gore & Associates. A.S. has been consultant for Cook Medical Inc., Artivion Inc., and Philips Healthcare. G.S.O has been a consultant for Cook Medical Inc., W. L. Gore & Associates, Inc., GE HealthCare Technologies, Inc., and Centerline Biomedical Inc. C.H.T. has been a consultant for and received research support from Cook Medical Inc., W. L. Gore & Associates, Inc., and Phillips Healthcare. M.A.F is a consultant for WL Gore, Cook Medical, Getinge, Centerline Biomedical and ViTAA Medical and received research support from Cook Medical and clinical trial support from W. L. Gore & Associates, Cook Medical, and ViTAA Medical., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Adverse iliofemoral anatomy may preclude complex endovascular aortic aneurysm repair (EVAR). In our practice, staged iliofemoral endoconduits (ECs) are planned prior to complex EVAR to improve vascular access and decrease operative time while allowing the stented vessel to heal. This study describes the long-term results of iliofemoral ECs prior to complex EVAR., Methods: Between 2012 and 2023, 59 patients (44% male; median age, 75 ± 6 years) underwent ECs before complex EVAR using self-expanding covered stents (Viabahn). For common femoral artery (CFA) disease, ECs were delivered percutaneously from contralateral femoral access and extended into the CFA to preserve the future access site for stent graft delivery. Internal iliac artery patency was maintained when feasible. During complex EVAR, the EC extended into the CFA was directly accessed and sequentially dilated until it could accommodate the endograft. Technical success was defined as successful access, closure, and delivery of the endograft during complex EVAR. Endpoints were vascular injury or EC disruption, secondary interventions, and EC patency., Results: Unilateral EC was performed in 45 patients (76%). ECs were extended into the CFA in 21 patients (35%). Median diameters of the native common iliac, external iliac, and CFA were 7 mm (interquartile range [IQR], 6-8 mm), 6 mm (IQR, 5-7 mm), and 6 mm (IQR, 6-7 mm), respectively. Internal iliac artery was inadvertently excluded in 10 patients (17%). Six patients (10%) had an intraoperative vascular injury during the EC procedure, and six patients (10%) had EC disruption during complex EVAR, including five EC collapses requiring re-stenting and one EC fracture requiring open cut-down and reconstruction with patch angioplasty. In 23 patients (39%), 22 Fr OD devices were used; 20 Fr were used in 22 patients (37%), and 18 Fr in 14 patients (24%). Technical success for accessing EC was 89%. There was no difference in major adverse events at 30 days between the iliac ECs and iliofemoral ECs. Primary patency by Kaplan-Meier estimates at 1, 3, and 5 years were 97.5%, 89%, and 82%, respectively. There was no difference in primary patency between iliac and iliofemoral ECs. Six secondary interventions (10%) were required. The mean follow-up was 34 ± 27 months; no limb loss or amputations occurred during the follow-up., Conclusions: ECs improve vascular access, and their use prior to complex EVAR is associated with low rates of vascular injury, high technical success, and optimal long-term patency. Complex EVAR procedures can be performed percutaneously by accessing the EC directly under ultrasound guidance and using sequential dilation to avoid EC disruption., Competing Interests: Disclosures M.S.B. and C.H.T. have been consultants for and received research support from Cook Medical Inc, W. L. Gore & Associates, Inc, and Phillips Healthcare. The other authors of this article have no relevant financial relationships to disclose per the JVS policy., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Short distances between the lowest visceral/renal artery and the aortic bifurcation are technically challenging during complex endovascular aortic aneurysm repair (EVAR), particularly after previous infrarenal repair. Traditionally, inverted limb bifurcated devices have been used in addition to fenestrated-branched (FB) endografts, but short overlap, difficult cannulation, and potential crushing of bridging stents are limitations for their use. This study reviews the early experience of patient-specific company manufactured devices (PS-CMDs) with a unibody bifurcated FB design for complex EVAR., Methods: Consecutive complex EVAR procedures over a 34-month period with unibody bifurcated FB-devices as part of physician-sponsored investigational device exemption studies at two institutions were reviewed. Unibody bifurcated FB designs included FB bifurcated or fenestrated inverted limb devices. End points included technical success, survival, frequency of type I or III endoleaks, limb occlusion, and secondary interventions., Results: Among 168 patients undergoing complex EVAR, 33 patients (19.6%; 78.7% male; mean age, 77 years) received unibody bifurcated FB PS-CMDs. FB bifurcated and fenestrated inverted limb devices were used in 31 (93.9%) and 2 (6.06%) patients, respectively. The median maximum aneurysm diameter was 61 mm (interquartile range [IQR], 55-69 mm). Prior EVAR was reported by 29 patients (87.9%), of whom 2 (6.06%) had suprarenal stents. A short distance between the lowest renal artery and aortic bifurcation was demonstrated in 30 patients (90.9%), with median distance of 47 mm (IQR, 38-54 mm). Preloaded devices were used in 23 patients (69.7%). A total of 128 fenestrations were planned; 22 (17.2%) were preloaded with guidewires and 5 (3.9%) with catheters. The median operative time was 238 minutes (226-300 minutes), with a median fluoroscopy time of 65.5 minutes (IQR, 56.0-77.7 minutes) and a median dose area product of 147 mGy∗cm 2 (IQR, 105-194 mGy∗cm 2 ). Exclusive femoral access was used in 14 procedures (42.4%). Technical success was 100%. Target vessel primary patency was 100% at a median follow-up time of 11.7 months (IQR, 3.5-18.6 months). Two patients (6.06%) required reintervention for iliac occlusion; one patient required stenting and the other a femoral-femoral bypass. No aortic-related deaths occurred after the procedure. During follow-up, 11 type II endoleaks (33.3%) and 1 type Ib endoleak (3.03%) were detected; the latter was treated with leg extension. No type Ia or III endoleaks occurred., Conclusions: Complex EVAR using unibody bifurcated FB-PS-CMDs is a simple, safe, and cost-effective alternative for the treatment of patients with short distances between the renal arteries and the aortic bifurcation. Further studies are required to assess benefits and durability of unibody bifurcated FB devices., Competing Interests: Disclosures M.S.B. and C.H.T. have been consultants for and received research support from Cook Medical Inc, W. L. Gore & Associates, Inc., and Phillips Healthcare. G.S.O has been a consultant for from Cook Medical Inc, W. L. Gore & Associates, Inc., Centerline Biomedical, and GE Healthcare., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Endovascular repair of chronic dissecting aortoiliac aneurysms is challenging given the rigid septum, compressed true lumen (TL), and target vessels frequently originating in the false lumen. We have used transcatheter electrosurgical aortic septotomy (TEAS) before stent graft implantation under intravascular ultrasound (IVUS) and fusion guidance. The purpose of this study is to assess the outcomes of TEAS during complex endovascular repair of dissecting aneurysms., Methods: From 2021 to 2023, 17 patients underwent TEAS. The primary end point was technical success, with secondary end points of proximal and distal seals, target vessel instability, aortic and iliac TL and cross-sectional area (CSA) expansion, and aortic-related death. During the procedure, the aortic septum is crossed through a pre-existing entry or via electrocautery-activated 0.018-in. Astato XS20 wire (Asahi-Intecc) under IVUS and fusion guidance. The penetrated wire is then snared in the false lumen and pulled through the ipsilateral femoral access. A 1-cm length of the middle of the Astato wire coating is kinked in a three-sided polygonal configuration, denuded the inner surface of the wire using a no. 15 blade, and positioned at the apex of the septum. Both ends of the Astato wire are insulated with 0.018-in. microcatheters, and the back end of the wire is denuded and connected to cautery. Gentle traction is applied to the wire, and short bursts of electrocautery cutting are applied at 60 to 80 W., Results: The technical success of the septotomy was 100%. No incidence of visceral or lower extremity malperfusion, vascular injury, or distal embolization occurred. Of the 17 patients, 4 underwent thoracic endovascular aneurysm repair, 2 underwent endovascular aortic repair, and 11 underwent fenestrated/branched endovascular aneurysm repair after septotomy. All target vessels were successfully stented. A distal landing zone seal with exclusion of the false lumen was achieved in 16 of the 17 patients (94.1%). One patient required embolization of the false lumen of the celiac artery after septotomy. The TL mean diameter and CSA of the descending thoracic aorta after septotomy was expanded by 7.01 ± 1.9 mm (relative mean diameter expansion, 42.3%; P  < .0001) and 2.71 ± 0.4 cm 2 (relative mean CSA expansion, 57.3%, P <.0001). For patients who required septotomy through the common iliac arteries, the mean TL was expanded by 8.1 ± 3.7 mm (relative mean diameter expansion, 76%; P  < .0001) and 1.76 ± 0.91 cm 2 (relative mean CSA expansion, 209%; P  < .0001). The 1-year freedom from target vessel instability was 91%., Conclusions: The use of IVUS and fusion-guided TEAS offers a promising technique to facilitate TL expansion and false lumen exclusion in chronic dissecting aortic aneurysms before repair. The durability and long-term outcomes of this technique in a larger cohort remain to be elucidated., Competing Interests: M.S.B. and C.H.T. have been consultants for, and received research support from, 10.13039/100010479Cook Medical Inc, W.L. Gore & Associates, Inc, and Phillips Healthcare. The remaining authors report no conflicts., (© 2024 The Author(s).)

Adverse iliofemoral anatomy can preclude complex endovascular aortic aneurysm repair. This study aims to describe the "up-and-over" staged endoconduit technique to improve access and avoid vascular injury before complex endovascular aneurysm repair. A staged procedure for complex endovascular aortic aneurysm repair is performed using an endoconduit (W.L. Gore & Associates). After obtaining contralateral femoral access, the extension of iliofemoral disease is assessed using angiography. The endoconduit is advanced "up and over" the aortic bifurcation and delivered percutaneously into the common femoral artery to treat a diseased access site and maintain intact the ipsilateral femoral access for future stent graft deployment. Internal iliac artery patency is maintained when feasible. During complex aneurysm repair, the endoconduit is accessed directly under ultrasound guidance using sequential dilation to avoid vascular injury. PerClose sutures (Abbott Vascular) are used to close the endoconduit femoral access site. This study found that staged "up and over" endoconduit creation is a useful technique before complex endovascular aneurysm repair in patients with adverse iliofemoral anatomy. Avoiding accessing the main femoral access site during the first stage prevents vascular or access site injuries and allows for both iliac and femoral disease to be addressed., Competing Interests: C.H.T. has been a consultant for, and received research support from, Cook Medical Inc, W.L. Gore & Associates, and Philips Healthcare. A.V.F., M.T.T., J.E.C.-F., M.S.G., and M.S.B. have no conflicts of interest., (© 2024 The Authors.)

Background: Many patients with metastatic bone disease (MBD) of the femur undergo prophylactic surgical fixation for impending pathologic fractures; intramedullary nailing (IMN) being the most common fixation type. However, surgeons often question if IMN fixation provides sufficient improvements in mechanical strength for particular metastatic lesions. Our goal was to use patient-specific finite element (FE) modeling to computationally evaluate the effects of simulated IMN fixation on the mechanics of femurs affected with MBD., Methods: Computed tomography (CT) scans were available retrospectively from 48 patients (54 femurs) with proximal femoral metastases. The CT scans were used to create patient-specific, non-linear, voxel-based FE models of the femur, simulating the instant of peak hip joint contact force during normal walking. FE analyses were repeated after incorporating virtual IMN fixation (Smith and Nephew, TRIGEN INTERTAN) into the same femurs. Femur strength and load-to-strength ratio (LSR; lower LSR indicates lower fracture risk) were compared between untreated and IMN conditions using statistical analyses., Results: IMN fixation resulted in a very modest average 10% increase in mechanical strength (p<0.001), which was associated with a slight 7% reduction in fracture risk (p<0.001). However, there was considerable variation in fracture risk reduction between individual femurs (0.13-50%). In femurs with the largest reduction in fracture risk (>10%), IMN hardware directly passed through a considerable section of that femur's metastatic lesion. Femurs with lytic (10%) and diffuse (9%) metastases tended to have greater reductions in fracture risk compared to femurs with blastic (5%) and mixed (4%) metastases (p=0.073)., Conclusion: Given the mechanically strong baseline condition of most femurs in this cohort, evident by the low fracture risk at the time of CT scanning, the relative increase in stiffness with the addition of the IMN hardware may not make a substantial contribution to overall mechanical strength. The mechanical gains of IMN fixation in femurs with MBD appear most beneficial when the hardware traverses an adequate section of the lesion. Level of Evidence: III ., Competing Interests: Disclosures: The authors report no potential conflicts of interest related to this study., (Copyright © The Iowa Orthopaedic Journal 2023.)

The preparation method of hydrogels has a significant effect on their structural and physicochemical properties. In this report, physically and chemically cross-linked poly(vinyl alcohol) (PVA) networks containing humic acid (HA) were alternatively prepared by autoclaving (AC) and through glutaraldehyde (GA) addition, respectively, for agricultural purposes. PVA/HA hydrogels were comparatively characterized by Fourier transform infrared spectroscopy, thermogravimetric analysis, mechanical assays, scanning electron microscopy, swelling kinetics measurements, and water retention tests in soil. AC hydrogels showed a more homogeneous porous microstructure, higher swelling levels, and a better capacity to preserve the humidity of soil than those obtained by adding GA. Both PVA/HA hydrogels exhibited no phytotoxicity on cultivation trials of Sorghum sp. , but the plant growth was promoted with the GA-cross-linked network as compared to the effect of the AC sample. The release behavior of urea was modified according to the preparation method of the PVA/HA hydrogels. After 3 days of sustained urea release, 91% of the fertilizer was delivered from the AC hydrogel, whereas a lower amount of 56% was released for the GA-cross-linked hydrogel. Beyond the advantages of applying PVA/HA hydrogels in the agricultural field, an appropriate method of preparing these materials endows them with specific properties according to the requirements of the target crop., Competing Interests: The authors declare no competing financial interest., (© 2023 The Authors. Published by American Chemical Society.)

Aims: The aim of this study was to determine the frequency of heterozygous truncating ALPK3 variants (ALPK3tv) in patients with hypertrophic cardiomyopathy (HCM) and confirm their pathogenicity using burden testing in independent cohorts and family co-segregation studies., Methods and Results: In a discovery cohort of 770 index patients with HCM, 12 (1.56%) were heterozygous for ALPK3tv [odds ratio(OR) 16.11, 95% confidence interval (CI) 7.94-30.02, P = 8.05e-11] compared to the Genome Aggregation Database (gnomAD) population. In a validation cohort of 2047 HCM probands, 32 (1.56%) carried heterozygous ALPK3tv (OR 16.17, 95% CI 10.31-24.87, P < 2.2e-16, compared to gnomAD). Combined logarithm of odds score in seven families with ALPK3tv was 2.99. In comparison with a cohort of genotyped patients with HCM (n = 1679) with and without pathogenic sarcomere gene variants (SP+ and SP-), ALPK3tv carriers had a higher prevalence of apical/concentric patterns of hypertrophy (60%, P < 0.001) and of a short PR interval (10%, P = 0.009). Age at diagnosis and maximum left ventricular wall thickness were similar to SP- and left ventricular systolic impairment (6%) and non-sustained ventricular tachycardia (31%) at baseline similar to SP+. After 5.3 ± 5.7 years, 4 (9%) patients with ALPK3tv died of heart failure or had cardiac transplantation (log-rank P = 0.012 vs. SP- and P = 0.425 vs. SP+). Imaging and histopathology showed extensive myocardial fibrosis and myocyte vacuolation., Conclusions: Heterozygous ALPK3tv are pathogenic and segregate with a characteristic HCM phenotype., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

The development of thermosensitive bioadhesive hydrogels as multifunctional platforms for the controlled delivery of microbicides is a valuable contribution for the in situ treatment of vagina infections. In this work, novel semi-interpenetrating network (s-IPN) hydrogels were prepared by the entrapment of linear poly(methyl vinyl ether- alt -maleic anhydride) (PVME-MA) chains within crosslinked 3D structures of poly( N -isopropylacrylamide) (PNIPAAm). The multifunctional platforms were characterized by Fourier transform infrared spectroscopy, scanning electron microscopy, thermal techniques, rheological analysis, swelling kinetic measurements, and bioadhesion tests on porcine skin. The hydrogels exhibited an interconnected porous structure with defined boundaries. An elastic, solid-like behavior was predominant in all formulations. The swelling kinetics were strongly dependent on temperature (25 °C and 37 °C) and pH (7.4 and 4.5) conditions. The s-IPN with the highest content of PVME-MA displayed a significantly higher detachment force (0.413 ± 0.014 N) than the rest of the systems. The metronidazole loading in the s-IPN improved its bioadhesiveness. In vitro experiments showed a sustained release of the antibiotic molecules from the s-IPN up to 48 h (94%) in a medium simulating vaginal fluid, at 37 °C. The thermosensitive and bioadhesive PNIPAAm/PVME-MA systems showed a promising performance for the controlled release of metronidazole in the vaginal environment.