Endovascular Devices Research Articles

Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices

The US Food and Drug Administration (FDA) is building a national postmarketing surveillance system for medical devices, moving to a "total product life cycle" approach whereby more limited premarketing data are balanced with postmarketing surveillance to capture rare adverse events and long-term safety issues. To assess the methodological requirements and feasibility of postmarketing device surveillance using endovascular aneurysm repair devices (EVARs), which have been the subject of safety concerns, using clinical data from a large health care system. This retrospective cohort study included patients with electronic health record (EHR) data in the Veterans Affairs Corporate Data Warehouse. Implantation of an AFX Endovascular AAA System (AFX) device (any of 3 iterations) or a non-AFX comparator EVAR device from January 1, 2011, to December 21, 2021. The primary outcomes were rates of type III endoleaks and all-cause mortality; and rates of these outcomes associated with AFX devices compared with non-AFX devices, assessed using Cox proportional hazards regression models and doubly robust causal modeling. Information on type III endoleaks was available only as free-text mentions in clinical notes, while all-cause mortality data could be extracted using structured data. Device-specific information required by the FDA is ascertained using unique device identifiers (UDIs), which include factors such as model numbers, catalog numbers, and manufacturer-specific product codes. The availability of UDIs in EHRs was assessed. In total, 13 941 patients (mean [SD] age, 71.8 [7.4] years) received 1 of the devices of interest (AFX with Strata [AFX-S]: 718 patients [5.2%]; AFX with Duraply [AFX-D]: 404 patients [2.9%]; or AFX2: 682 patients [4.9%]), and 12 137 (87.1%) received non-AFX devices. The UDIs were not recorded in the EHR for any patient with an AFX device, and partial UDIs were available for 19 patients (0.1%) with a non-AFX device. This necessitated the development of advanced natural language processing tools to define the cohort of patients for analysis. The study identified a significantly higher risk of type III endoleaks at 5 years among patients receiving any of the AFX device iterations, including the most recent version, AFX2 (11.6%; 95% CI, 8.1%-15.1%) compared with that among patients with non-AFX devices (5.7%; 95% CI, 2.2%-9.2%; absolute risk difference, 5.9%; 95% CI, 2.3%-9.4%). However, there was no significantly higher all-cause mortality for any of the AFX device iterations, including for AFX2 (19.0%; 95% CI, 16.0%-22.0%) compared with non-AFX devices (18.0%; 95% CI, 15.0%-21.0%; absolute risk difference, 1.0%; 95% CI, -2.1% to 4.1%). The findings of this cohort study suggest that clinical data can be used for the postmarketing device surveillance required by the FDA. The study also highlights ongoing challenges to performing larger-scale surveillance, including lack of consistent use of UDIs and insufficient relevant structured data to efficiently capture certain outcomes of interest.

A Bayesian network meta-analysis for acute thrombosis after lower extremity artery endovascular treatment.

Various endovascular treatment devices have been widely used in the lower extremity arterial disease (LEAD). Their patency efficiency for target lesions has been well studied and reported. Comparison of the risk of acute thrombosis events between the different endovascular treatment devices is unclear. To rank the risk of acute thrombosis events when bare metal stents (BMSs), covered stents (CSs), drug-eluting stents (DESs), drug-coated balloons (DCBs), and conventional percutaneous transluminal balloon angioplasty (PTA) are used to treat LEAD through Bayesian network meta-analysis. We performed a network meta-analysis of randomized controlled trials comparing the risk of 1-year postoperative acute thrombosis between BMSs, CSs, DESs, DCBs, and PTA for treating LEAD. Bayesian random models were used for pooled endovascular treatment modality comparisons. We ranked these treatment modalities via the Bayesian method according to their surface under the cumulative ranking curve (SUCRA) and estimated probabilities. Nineteen studies (38 study arms; 2758 patients) were included. The Bayesian network ranking of treatments indicated that DCB had the lowest risk of acute thrombosis, PTA had the second-lowest risk of thrombosis, and CS, BMS, and DES had the highest risk of thrombosis. Regarding the treatment efficacy, the OR values of the loss of primary patency were significantly lower for DCB (OR = 0.44, 95% CI: 0.30-0.62), DES (OR = 0.36, 95% CI: 0.14-0.94), and CS (OR = 0.31, 95% CI: 0.18,0.56) than for PTA. When BMS was used as a reference, only the OR for CS was significantly lower (OR = 0.41, 95% CI = 0.21-0.82). Correspondingly, the Bayesian ranking of treatments from better to worse target lesion primary patency was CS, DES, DCB, BMS, and PTA. With the available research evidence and according to the network analysis ranking, DES appears to have the highest risk of acute thrombosis and DCB appears to have the lowest risk.

Large, Wide-Neck, Side-Wall Aneurysm Treatment in Canines Using NeuroCURE: A Novel Liquid Embolic.

Untreated intracranial aneurysms can rupture and result in high rates of morbidity and mortality. Although there are numerous approved endovascular aneurysm treatment devices, most require dual anti-platelet therapy, are minimally biocompatible, or are prone to recanalization. Neurovascular Controlled Uniform Rapid Embolic (NeuroCURE) is an innovative polymer gel material with long-term stability, biocompatibility, and hemocompatibility developed for the treatment of large, wide-neck aneurysms. Sidewall aneurysms were surgically created in 10 canines and NeuroCURE was injected through a 0.025 microcatheter under a single balloon inflation period. Aneurysm treatment was angiographically assessed post-embolization and pre-term with Raymond-Roy occlusion classification and a qualitative flow grade scale. Aneurysm neck stability and biocompatibility was histologically assessed to grade platelet/fibrin thrombus, percent endothelialization, and neointimal formation. Aneurysm sac stability was assessed by NeuroCURE sac content, inflammation, and neo-angiogenesis scales. Explanted aneurysms exhibited a smooth surface at the aneurysm neck with nearly complete neointimal coverage at 3-months. By 6-months, neck endothelialization was 100% in all animals (average Raymond-Roy occlusion classification of 1.2), with no instances of aneurysm recanalization or parent vessel flow compromise. Biocompatibility assessments verified a lack of inflammatory response, neo-angiogenesis, and platelet/fibrin thrombus formation. The NeuroCURE material promotes progressive occlusion of wide-necked side wall aneurysms over time without the need for dual antiplatelet agents. NeuroCURE also promotes neointimal tissue infill without dependence on thrombus formation and thus resists aneurysm recanalization. NeuroCURE remains a compelling investigational device for the treatment of intracranial aneurysms.

Assessing a heterogeneous model for accounting for endovascular devices in hemodynamic simulations of cerebral aneurysms.

The heterogeneous model developed by Berod et al [Int J Numer Method Biomed Eng 38, 2021] for representing the hemodynamic effects of endovascular prostheses is applied to a series of 10 patient specific cerebral aneurysms, 6 being treated by flow diverters, 4 being equipped with WEBs. Two markers correlated with the medical outcome of the treatment are used to assess the potential of the model, namely the saccular mean velocity and the inflow rate at the neck of the aneurysm. The comparison with the corresponding wire-resolved simulations is very favorable in both cases, and the model-based simulations also retrieve the jetting-type flows generated downstream of the struts. Noteworthy, the very same model was used for representing the flow diverters and the WEBs, showing the versatility and robustness of the heterogeneous modeling of the devices.

Novel endovascular transmural technique for pharmacological block of superior cervical ganglion prevents sympathetic-mediated cerebral vasospasm

BackgroundSympathetic-mediated vasoconstriction from the superior cervical ganglion (SCG) is a significant contributor to cerebral vasospasm. Inhibition of the SCG has been shown to improve cerebral blood flow and reverse cerebral...

Endovascular Treatment of Cerebrovascular Lesions Using Nickel- or Nitinol-Containing Devices in Patients with Nickel Allergies.

Nickel is used in many cerebral endovascular treatment devices. However, nickel hypersensitivity is the most common metal allergy, and the relative risk of treatment in these patients is unknown. This retrospective analysis identified patients with nickel or metal allergies who underwent cerebral endovascular treatment with nickel-containing devices. Seven patients with nickel and/or other metal allergies underwent treatment with 9 nickel-containing devices. None experienced periprocedural complications. No patient received treatment with corticosteroids or antihistamines. At a mean clinical follow-up for all patients of 22.8 months (range, 10.5-38.0 months), no patients had symptoms attributable to nickel allergic reactions. The mean radiographic follow-up for all patients at 18.4 months (range, 2.5-37.5 months) showed successful treatment of the targeted vascular pathologies, with no evidence of in-stent stenosis or other allergic or hypersensitivity sequelae. The treatment of cerebrovascular lesions with a nickel-containing device resulted in no adverse outcomes among these patients and was safe and effective.

Frequency and Characteristics of Paraclinoid Aneurysm in Ruptured Cerebral Aneurysms.

This study aimed to determine the frequency of paraclinoid aneurysms among ruptured cerebral aneurysms and compare paraclinoid aneurysms with other aneurysms to clarify the characteristics of ruptured paraclinoid aneurysms. This study included 970 ruptured cerebral aneurysms treated at our hospital between 2003 and 2020. There were 15 cases (1.3%) of paraclinoid aneurysms with maximum diameters of 5-22 mm (mean±standard deviation [SD], 11.6±5.4 mm). Treatment consisted of clipping in four patients and endovascular treatment in 11. Factors significantly different in multivariate analysis for paraclinoid aneurysms compared with those for other aneurysms were a history of hypertension (odds ratio [OR], 1.2-9.8; p=0.021) and aneurysm ≥10 mm (OR, 7.5-390.3; p<0.001). The sites of paraclinoid aneurysm were ophthalmic artery type in nine patients, anterior wall type in five, medial wall type in one, and ventral wall type in zero. The medial wall type (22 mm) was significantly larger than the ophthalmic artery type (mean±SD, 7.2±2.0 mm) (p=0.003), and the anterior wall type (mean±SD, 12.2±4.8 mm) was significantly larger than the ophthalmic artery type (p=0.024). This study showed a low frequency of paraclinoid aneurysms among ruptured cerebral aneurysms. Most were upward-facing with relatively large aneurysms, and no aneurysms were smaller than 5 mm. With recent advances in endovascular treatment devices, paraclinoid aneurysms are easily treatable. However, the treatment indication of each paraclinoid aneurysm should be carefully considered.

Prediction of guidewire-induced aortic deformations during EVAR: a finite element and in vitro study.

Introduction and aims: During an Endovascular Aneurysm Repair (EVAR) procedure a stiff guidewire is inserted from the iliac arteries. This induces significant deformations on the vasculature, thus, affecting the pre-operative planning, and the accuracy of image fusion. The aim of the present work is to predict the guidewire induced deformations using a finite element approach validated through experiments with patient-specific additive manufactured models. The numerical approach herein developed could improve the pre-operative planning and the intra-operative navigation. Material and methods: The physical models used for the experiments in the hybrid operating room, were manufactured from the segmentations of pre-operative Computed Tomography (CT) angiographies. The finite element analyses (FEA) were performed with LS-DYNA Explicit. The material properties used in finite element analyses were obtained by uniaxial tensile tests. The experimental deformed configurations of the aorta were compared to those obtained from FEA. Three models, obtained from Computed Tomography acquisitions, were investigated in the present work: A) without intraluminal thrombus (ILT), B) with ILT, C) with ILT and calcifications. Results and discussion: A good agreement was found between the experimental and the computational studies. The average error between the final in vitro vs. in silico aortic configurations, i.e., when the guidewire is fully inserted, are equal to 1.17, 1.22 and 1.40 mm, respectively, for Models A, B and C. The increasing trend in values of deformations from Model A to Model C was noticed both experimentally and numerically. The presented validated computational approach in combination with a tracking technology of the endovascular devices may be used to obtain the intra-operative configuration of the vessels and devices prior to the procedure, thus limiting the radiation exposure and the contrast agent dose.

A Novel Endovascular Robotic System for Treatment of Lower Extremity Peripheral Arterial Disease: First-in-Human Experience.

To assess the feasibility and first-in-human experience of a novel endovascular robotic system for treatment of lower extremity peripheral arterial disease (PAD). Between November 2021 and January 2022, consecutive patients with obstructive lower extremity PAD and claudication (Rutherford 2-5) with >50% stenosis demonstrated on angiography were enrolled in this study. Lower extremity peripheral arterial intervention was performed using the endovascular robotic system, which consisted of a bedside unit and an interventional console. The primary endpoints were technical success, defined as the successful manipulation of the lower extremity peripheral arterial devices using the robotic system, and safety. The secondary endpoints were clinical success, defined as 50% residual stenosis at the completion of the robot-assisted procedure without major adverse cardiac events and radiation exposure. In total, 5 patients with PAD were enrolled in this study (69.2±6.0 years; 80% men). The novel endovascular robotic system successfully completed the entire procedure of endovascular treatment of lower extremity PAD. Conversion to manual operation, including advancement, retracement, rotation of the guidewires, catheters, sheaths, deployment, and release of the balloons and stent grafts, was not necessary. We achieved the criteria for clinical procedural and technical success in all patients. No deaths, myocardial infarctions, or ruptures occurred in the period up to 30 days after the procedure, and no device-related complications were observed. The robotic system operator had 97.6% less radiation exposure than that at the procedure table, with a mean of 1.40±0.49 μGy. This study demonstrated the safety and feasibility of the robotic system. The procedure reached technical and clinical performance metrics and resulted in significantly lower radiation exposure to the operators at the console compared with that at the procedure table. There were some reports about several robotic systems used in the peripheral arterial disease, but no robotic system was able to perform entire procedure of endovascular treatment of lower extremity peripheral arterial disease (PAD).To solve this problem, we designed a remote-control novel endovascular robotic system. It was the first robotic system that can perform entire procedure of endovascular treatment of PAD worldwide. A novelty retrieval report about this is provided in the supplementary materials.The robotic system is compatible with all commercial endovascular surgical devices currently available in the market, including guidewires, catheters and stent delivery systems. It can perform all types of motion, such as forward, backward, and rotation to meet the requirements of all types of endovascular procedures. During the operation, the robotic system can perform these operations in a fine-tuned manner, so it is easy to cross the lesions, which is the key factor influencing the success rate of the operation. In addition, the robotic system can effectively reduce the exposure time to radiation, thereby reducing the risk of occupational injury.

Ultra-High-Resolution Time-of-Flight MR-Angiography for the Noninvasive Assessment of Intracranial Aneurysms, Alternative to Preinterventional DSA?

PurposeThe 3D time-of-flight (TOF) magnetic resonance angiography (MRA) at 3T shows high sensitivity for intracranial aneurysms but is inferior to three-dimensional digital subtraction angiography (3D-DSA) regarding aneurysm characteristics. We applied an ultra-high-resolution (UHR) TOF-MRA using compressed sensing reconstruction to investigate the diagnostic performance in preinterventional evaluation of intracranial aneurysms compared to conventional TOF-MRA and 3D-DSA.MethodsIn this study 17 patients with unruptured intracranial aneurysms were included. Aneurysm dimensions, configuration, image quality and sizing of endovascular devices were compared between conventional TOF-MRA at 3T and UHR-TOF with 3D-DSA as gold standard. Quantitatively, contrast-to-noise ratios (CNR) were compared between TOF-MRAs.ResultsOn 3D-DSA, 25 aneurysms in 17 patients were detected. On conventional TOF, 23 aneurysms were detected (sensitivity: 92.6%). On UHR-TOF, 25 aneurysms were detected (sensitivity: 100%). Image quality was not significantly different between TOF and UHR-TOF (p = 0.17). Aneurysm dimension measurements were significantly different between conventional TOF (3.89 mm) and 3D-DSA (4.2 mm, p = 0.08) but not between UHR-TOF (4.12 mm) and 3D-DSA (p = 0.19). Irregularities and small vessels at the aneurysm neck were more frequently correctly depicted on UHR-TOF compared to conventional TOF. Comparison of the planned framing coil diameter and flow-diverter (FD) diameter revealed neither a statistically significant difference between TOF and 3D-DSA (coil p = 0.19, FD p = 0.45) nor between UHR-TOF and 3D-DSA (coil: p = 0.53, FD 0.33). The CNR was significantly higher in conventional TOF (p = 0.009).ConclusionIn this pilot study, ultra-high-resolution TOF-MRA visualized all aneurysms and accurately depicted aneurysm irregularities and vessels at the base of the aneurysm comparably to DSA, outperforming conventional TOF. UHR-TOF with compressed sensing reconstruction seems to represent a non-invasive alternative to pre-interventional DSA for intracranial aneurysms.

Introduction to the special section on endovascular graft devices for TAAA repair advantages and limitations.

Introduction to the special section on endovascular graft devices for TAAA repair advantages and limitations.

Introduction: Operative Neurosurgery Technical Lessons Video Series

When Godfather II was released almost half a century ago, it was widely considered the best sequel ever made. It was also the first sequel to receive the Best Picture award from the Academy of Motion Picture Arts and Sciences, and together with the original, the pair remains at the pinnacle of movie-making today. The Operative Neurosurgery Technical Lessons Video Series is also a sequel of sorts, and if it can approximate how closely the sequel emulated The Godfather, it would greatly satisfy all of us involved in its creation. So, what of the original to our remake? Neurosurgical Procedures: Personal approaches to classic operations was published in 1992.1 In this vastly useful and widely popular book, editor Dr Charles Wilson solicited 20 of his friends, all “seasoned neurosurgeons” per his preface, to write “how to” chapters about their favorite approach. By intention, the authors were encouraged to highlight their personal experiences, and as such, the language of scientific discourse was put aside and replaced with authoritative voices that were personal, in some cases even intimate, and therefore, imminently relatable. Giants of neurosurgery were well-represented in this book. The venerable Thoralf Sundt discussed bypass surgery to treat cavernous aneurysms, and John Jane wrote about orbital approaches. Like Peter Jannetta, who authored a chapter on microvascular decompression, the writers were the ones who developed the operations and defined the boundaries of their indications. Their collective work can be considered a snapshot of the “best practice” in neurosurgery during the late 1980s. Picking up the book today, the content seems unusably outdated. Although cures of glioblastoma and prevention of spinal stenosis remain elusive, neurosurgery has taken a quantum leap since 1992. The development of endovascular devices, the ubiquitous presence of contemporary navigation systems, and the partnership of the modern neurosurgeons with skull base rhinologists have all turned Dr Wilsons' book into a historical monument. And so, this remake is to update the original, hopefully achieving the same usefulness, connection with the audience, and popularity of it. Because neurosurgery itself has modernized in the past 4 decades, so too has the teaching of it. Neurosurgical trainees around the world rely heavily on social media, not only for connection with each other but also for learning, and platforms such as YouTube has made operative videos widely disseminated, powerful tools for teaching neurosurgery. Although our movies are not necessarily directed by Francis Ford Coppola, still, watching a 10-minute movie demonstrating a surgical technique is more engaging to most viewers than reading a 20-page chapter. For this reason, the Operative Neurosurgery Technical Lessons Video Series is designed to be a collection of surgical videos, produced by experienced neurosurgeons, each demonstrating their favorite procedure, or to borrow words from Dr Wilson again, “the approach… associate(d) particularly with them.” Each episode is focused on a single procedure, and again, the producers are encouraged to concentrate on their personal experiences, honed by many repetition, and influenced by their unique portfolio of complications and to forego comprehensive expositions of alternative techniques and exhaustive data to support the indications of the variations. Thusly imbued with the voice of the producer and equal parts Arts and Science, the videos will hopefully come across to the viewer as personal, compact, and digestible. As a collection, the series strives to resonate with the community as a superb collection of modern cranial neurosurgery. Selection for the list was art in itself, and we thank Editor-in-Chief Doug Kondziolka for personally participating in this process, beyond simply encouraging the project to move forward. The symbol we chose to represent this series is da Vinci's “Vitruvian Man” superimposed on the brain. In many ways, the most iconic image of western civilization, Leonardo's drawing depicts a perfectly proportioned human fit simultaneously into a circle and square. It symbolizes the equipoise of Arts and Science, a balance which is the ideal of the High Renaissance. Similarly, this series strives to achieve the same balance of the 2 and aim to be a worthy sequel. On behalf of the Editorial Board, Journal Editor, Operative Neurosurgery, Rachel Lowery, and the Operative Neurosurgery staff, we hope the videos provide you many hours of learning.

Comprehensive mechanical performance characteristics of newly developed ultra-thin coronary stents

Endovascular technologies such as percutaneous transluminal coronary angioplasty and stenting are widely used due to being minimally invasive procedures. One of the endovascular devices, a drug-eluting stent (DES), proved to be a safe and effective therapeutic option for cardiologists, substantially reducing in-stent restenosis (ISR) rates. DES consists of thin (< 200 µm) or ultra-thin (< 70 µm) struts made of Cobalt-Chromium (CoCr) or other alloys. The DES with ultra-thin struts exhibits higher longitudinal flexibility and improved trackability. It also reduces vascular injury and promotes more rapid endothelization, substantially decreasing the risk of ISR. This study evaluates comprehensive mechanical performances of two different structural designs of newly developed ultra-thin CoCr stents (i.e., strut width of 75 µm or 65 µm). These two stent designs are engineered with distinct bridge size and distribution patterns, prioritizing enhanced flexibility irrespective of the strut thickness. Computational modeling results show anticipated stress distribution with maximum local stresses, which are compared with experimental outcomes conducted in this study. ASTM guideline based in vitro experimental studies have been conducted to assess the stents’ longitudinal flexibility, radial strength, recoil and shortening, as well as crushability through this study. Three-point bending experiments have demonstrated that the stent design 1 requires less bending force compared to the design 2, showing better longitudinal flexibility of the stent design 1 in the collapsed state for the new ultra-thin DES devices. The design 1 also showed superior radial strength and recoiling phenomena, as well as smaller shortening. In short, the stent design 1 shows better mechanical performance needed for the coronary artery DES.

Cardiac Pulsatile Helical Deformation of the Thoracic Aorta Before and After Thoracic Endovascular Aortic Repair of Type B Dissections.

Type B aortic dissections propagate with either achiral (nonspiraling) or right-handed chiral (spiraling) morphology, have mobile dissection flaps, and are often treated with thoracic endovascular aortic repair (TEVAR). We aim to quantify cardiac-induced helical deformation of the true lumen of type B aortic dissections before and after TEVAR. Retrospective cardiac-gated computed tomography (CT) images before and after TEVAR of type B aortic dissections were used to construct systolic and diastolic 3-dimensional (3D) surface models, including true lumen, whole lumen (true+false lumens), and branch vessels. This was followed by extraction of true lumen helicity (helical angle, twist, and radius) and cross-sectional (area, circumference, and minor/major diameter ratio) metrics. Deformations between systole and diastole were quantified, and deformations between pre- and post-TEVAR were compared. Eleven TEVAR patients (59.9±4.6 years) were included in this study. Pre-TEVAR, there were no significant cardiac-induced deformations of helical metrics; however, post-TEVAR, significant deformation was observed for the true lumen proximal angular position. Pre-TEVAR, cardiac-induced deformations of all cross-sectional metrics were significant; however, only area and circumference deformations remained significant post-TEVAR. There were no significant differences of pulsatile deformation from pre- to post-TEVAR. Variance of proximal angular position and cross-sectional circumference deformation decreased after TEVAR. Pre-TEVAR, type B aortic dissections did not exhibit significant helical cardiac-induced deformation, indicating that the true and false lumens move in unison (do not move with respect to each other). Post-TEVAR, true lumens exhibited significant cardiac-induced deformation of proximal angular position, suggesting that exclusion of the false lumen leads to greater rotational deformations of the true lumen and lack of true lumen major/minor deformation post-TEVAR means that the endograft promotes static circularity. Population variance of deformations is muted after TEVAR, and dissection acuity influences pulsatile deformation while pre-TEVAR chirality does not. Description of thoracic aortic dissection helical morphology and dynamics, and understanding the impact of thoracic endovascular aortic repair (TEVAR) on dissection helicity, are important for improving endovascular treatment. These findings provide nuance to the complex shape and motion of the true and false lumens, enabling clinicians to better stratify dissection disease. The impact of TEVAR on dissection helicity provides a description of how treatment alters morphology and motion, and may provide clues for treatment durability. Finally, the helical component to endograft deformation is important to form comprehensive boundary conditions for testing and developing new endovascular devices.

Double-Barrel Technique With Reversed Gore Excluder Stent Graft Limb for Common Iliac Aneurysm Exclusion in a Patient With Prior Aortic Surgical Repair.

Surgical repair of a common iliac artery aneurysm (CIA) after previous open aortic reconstruction is associated with significant morbidity and mortality. Endovascular repair is considered less invasive than surgery. However, if preservation of the internal iliac artery (IIA) is required, the applicability of endovascular techniques may represent a challenge and a limitation to the use of standard aortic endografts or iliac branch devices. In these cases, the off-label use of endovascular devices may be an effective alternative. Herein, we report a successful hybrid approach to treat CIA using a reversed iliac limb endograft coupled with a double-barrel technique with femoro-femoral crossover bypass in a patient who had previously undergone open aortic reconstruction.

Needle fenestration of popliteal artery covered stent graft to salvage inadvertent stent misdeployment

Endovascular methods have transformed treatment of lower extremity peripheral arterial disease but can still present technical challenges. We report the case of a 69-year-old man with rest pain who underwent superficial femoral artery recanalization with covered stents. During completion angiography, the distal stent was discovered to have been misdeployed into an anterior geniculate branch overlying the behind-the-knee popliteal artery. Subsequently, an endovascular reentry device was used to fenestrate the stent posteriorly to enter the lumen of the popliteal artery. Cutting balloons were used to enlarge the fenestration in the stent fabric, with placement of an additional 6× 50-mm covered stent bridging from the popliteal artery into the fenestrated misdeployed covered stent. Completion angiography demonstrated no evidence of distal embolization and patent two-vessel runoff. The patient had an uncomplicated recovery and at 2 years of follow-up remained asymptomatic with documented popliteal stent patency.

Is There a Difference in Patency Between Patients Undergoing Venous Stenting for Acute Deep Venous Thrombosis Following Thrombus Removal Versus Post-thrombotic Syndrome Stenoses?

Venous stenting was introduced in the 1990s and has continued to evolve to become the first-line therapy for symptomatic iliofemoral venous outflow pathology. There are several dedicated venous stents available in addition to Boston Scientific’s Wallstent and Cook’s Z-Stent. Numerous studies from tertiary referral centres, as well as industry-sponsored trials, have demonstrated the safety and efficacy of these endovascular devices for non-thrombotic iliac vein (NIVL) and post-thrombotic syndrome (PTS) lesions. Patients presenting with acute deep venous thrombosis (aDVT) may also undergo stenting following thrombus removal. The standard of care for NIVL, PTS and aDVT patients has become venography and intravascular ultrasound, and if an underlying iliofemoral stenosis is identified, a stent is placed. There is a concern that inflammation may affect the results of stenting in the aDVT population. Although endovascular stenting for acute venous diseases appears promising and safe, there is a paucity of data on efficacy in aDVT patients. There are only two industry-sponsored trials and a few publications and presentations at academic society meetings to examine. This review assesses the available results for endovascular stenting for aDVT and PTS patients, but not for NIVL.

Novel Approach to treating a COVID-19 positive patient with a Complex Arch and Descending Aneurysm and Dissection in whom open surgery is prohibitive.

Ascending aortic and arch aneurysms are a challenging group of pathologies for surgeons. These typically require a complex open repair, including hypothermic circulatory arrest and carry a high peri-operative risk. Outcomes are best when performed in centers with significant experience and expertise. Many patients, because of co-morbidities, are at a prohibitive risk for these open surgeries. Thoracic endovascular aortic repair (TEVAR) has become the preferred treatment of most acute descending thoracic aortic pathologies.[1] However, these require strict anatomic criteria to be successful and are usually confined to the distal arch and descending thoracic aorta. There are no commercially available endovascular devices in the United States to treat this patient population with ascending or proximal arch aneurysms or dissections, especially in an urgent or emergent setting, whose anatomy does not meet criteria for standard TEVAR. We present a novel endovascular approach, including a cerebral protection strategy, to treat a complex arch aneurysm and dissection in a patient who was not a candidate for an open repair.

A Case Series of Late Vascular Lesions of Traumatic Etiology: Endovascular and Surgical Approaches.

There is a broad spectrum of pathology in traumatic vascular injury. Arteriovenous fistula (AVF) is an abnormal communication between the high-flow arterial system and the low-flow venous network, directly connecting the afferent artery and nearby draining veins without the regular intervention of the capillary bed. Most of these fistulas occur due to incidental or iatrogenic injury. A retrospective review of procedures performed by an endovascular surgeon in a tertiary center identified 15 cases of vascular injuries that encompassed all these different clinical scenarios, including post-traumatic, iatrogenic, or spontaneous origin. The information collected, including patient age, sex, previous symptoms, and treatment, was gathered from medical records. In addition, information on procedural technique, endovascular devices used, and specific intraprocedural details were collected from procedure notes and angiographic images. A broad spectrum of injuries can present as late trauma complications (over three months); endovascular treatment is a safe and effective approach for intracranial and extracranial injuries. Endovascular treatment can be a sole option or adjuvant to other hybrid therapies and has emerged as essential for treating these lesions as a first option. We have described standard techniques to treat different vascular pathologies, sometimes with limited resources.

The Effects of a National Recall on the Reports to the FDA Manufacturer and User Facility Device Experience Database of a Common Atherectomy Device

The HawkOne Directional Atherectomy System (Medtronic Inc., Minneapolis, MN) is a peripheral arterial disease management system that was recalled in December 2021 secondary to repeated guidewire prolapse. We set forth to analyze the patient problems and device issues that caused the device to be recalled and determine if the recall had a significant impact on the device reports utilizing the US Food and Drug Administration (FDA) database Manufacturer and User Facility Device Experience (MAUDE). MAUDE was queried for all adverse report events for the HawkOne device six months prior to and after its recall date in December 2021. Data collected included patient-based issues, device-based issues, and if the device was evaluated by the manufacturer. Fisher's exact test was utilized. There were 72 unique events reported prior to the device recall and 35 events reported after the recall. The majority of adverse events resulted in no adverse clinical outcomes before (55.6%) and after (21.3%) the recall. The most common reported device issue was detachment both before (54.8%) and after (57.1%) the recall. There was no significant difference in the rate of any patient outcome or device problem after the recall. The number of devices evaluated by the manufacturer after the recall was significantly reduced (69.9% vs 11.4%; P ≤ .001). There was no significant change in the rate of specific patient outcomes or device issues after the HawkOne device recall. The rate at which the devices were evaluated by the manufacturer significantly reduced after the recall. These data indicate possible influences that an official device recall might have on reporting to the MAUDE and warrant further study to understand the complexity of user-based feedback of such endovascular devices.