Cook Medical Research Articles

Abstract No. 589 Reconstruction of Upper Extremity and Thoracic Central Veins Using Dedicated Venous Stents: Deployment of 75 Stents in 46 Patients

Dedicated bare-metal venous stents, including Abre (Medtronic; Dublin, Ireland), Venovo (Becton, Dickinson, and Company; Franklin Lakes, NJ), Vici (Boston Scientific; Marlborough, MA), and Zilver Vena (Cook Medical; Bloomington, IN), are approved for treatment of iliofemoral venous occlusive diseases. This study describes the use of these stents in the upper extremity and thoracic central veins. Forty-six patients (24 females and 22 males; mean age 52.8 ± 15.5 years) underwent reconstruction of the upper extremity and thoracic central veins using dedicated venous stents from 10/17/2019 to 08/15/2022. All patients presented with swelling, 21 with pain, three with dysphagia, and one with dyspnea. Stent placement parameters (type, location, diameter, length), technical success (stent deployment resulting in patent in-line flow), adverse events, clinical success (resolution of presenting symptoms), and revision parameters were recorded. Seventy-five stents were deployed during 52 procedures. Venous stents used included 43 Abre, 21 Venovo, seven Vici, and four Zilver Vena. Reconstructed veins included: superior vena cava (SVC)-to-bilateral brachiocephalic veins (BCVs) (n = 12), unilateral BCV (n = 12), SVC-to-unilateral BCV (n = 9), SVC only (n = 8), SVC-to-unilateral subclavian vein (SCV) (n = 6), and unilateral BCV-to-SCV (n = 5). Overall mean stent diameter was 13.7 ± 2.0-mm. Mean stent diameters of Abre, Venovo, Vici, and Zilver Vena were 13.2 ± 1.8-mm, 15.2 ± 1.8-mm, 12.3 ± 0.8-mm, and 14 ± 0-mm, respectively. Technical success was achieved in all procedures. One Venovo stent malexpansion occurred which responded to angioplasty. One patient experienced an access site hematoma at the left brachial vein which resolved without intervention. Clinical success was achieved in all patients. No stent fractures or migrations occurred. Six patients required stent revisions at mean of 124.3 ± 82.1 days after the initial procedures. The use of dedicated venous stents in the upper extremity and thoracic central veins yielded excellent technical and clinical success rates without immediate adverse events.

Endovascular Repair of a Splenic Artery Aneurysm Arising from the Superior Mesenteric Artery

A 55 year old man presented with recurrent dull abdominal pain for two months. Computed tomography angiography revealed a splenic artery aneurysm (A, asterisk) 24 × 24 mm originating from the SMA (A, arrow) a rare finding. Endovascular repair with coil (Cook Medical, Bloomington, IN, USA), embolisation of the splenic artery, and covered stents (8 × 25 mm + 8 × 50 mm; Viabahn, Gore, Flagstaff, AZ, USA) in the SMA was performed. The post-operative course was uneventful. Aspirin was continued for one year. After two years the SMA was patent with no aneurysm recurrence (B, arrow).Image 1

Zilver stent versus Carotid Wallstent for endovascular treatment of idiopathic intracranial hypertension

BackgroundVenous sinus stenting (VSS) is a promising treatment option for medically refractory idiopathic intracranial hypertension (IIH). There are no published studies comparing the performance of different types of stents employed...

The Delorme Procedure.

Spectrum Health Grand Rapids General Surgery Residency Spectrum Health Grand Rapids Colon and Rectal Surgery Funding/Support: None reported. Financial Disclosures: Dr. Ogilvie is a current consultant for Cook Medical. Dr. Khan has no disclosures. Proof of consent obtained. Correspondence: Mariam Khan, M.D., 4100 Lake Drive SE Suite 205, Grand Rapids, MI 49546. Email: [email protected];[email protected]

The Carbon Dioxide Flushing Technique: A Novel Approach Using Oxygen Measurements to Evaluate the Elimination of Room Air from Thoracic Stent-Grafts

Background: The study evaluates a novel technique using oxygen measurements to indirectly evaluate the behavior of carbon dioxide (CO2) in the residual gas released by thoracic stent-grafts and to better understand the mechanism of the CO2 flushing technique. Methods: Ten Zenith TX2 ProForm thoracic stent-grafts (ZDEG-PT-34-199-PF, Cook Medical, Bjæverskov, Denmark) were equally divided into 2 groups (Group A and B). Group A was flushed with 60 ml of 0.9% saline. Group B was flushed with 100% carbon dioxide gas followed by 60 ml of 0.9% saline. The stent-grafts were deployed into a plastic tube that was placed and fixated to the bottom of a translucent container filled with water to collect the residual air released by the stent-grafts. Oxygen (O2) concentration and gas volume were measured in the released gas. Results: The oxygen concentration was significant (p<0.001) lower after additional carbon dioxide flush compared to standard flush (18.5% vs 19.6%). Furthermore, the absolute oxygen volume was significantly lower after additional carbon dioxide flush than without (0.18 ml vs 0.32 ml, p=0.041). The total amount of released gas appeared lower with carbon dioxide flush than without (0.98 ml vs 1.65, P=0.058). Conclusions: CO2 absorption into saline and replacement of room air by CO2 inside the stent-graft may lead to a reduction of released gas during stent-graft deployment in an experimental setting.

Evaluation of hydrophilic polymer embolization from endovascular sheath devices in an in vitro perfusion system

ObjectiveCase reports, tissue pathology, and autopsies have suggested that the hydrophilic polymer coating designed to improve endovascular deliverability and minimize vessel trauma can embolize and be associated with adverse outcomes such as ischemia, infarction, and death. This study sought to determine whether hydrophilic polymers shed off commercially available sheaths in a controlled in vitro environment, with the hypothesis that significant differences between coated and uncoated (control) sheaths would be found. MethodsSix sheaths from each manufacturer, including Zenith Alpha abdominal endovascular stent grafts (Cook Medical), DrySeal sheaths (W.L. Gore & Associates), and Sentrant Introducer sheaths (Medtronic), were tested in an in vitro environment. Noncoated Check-Flo performer introducer sheaths (Cook Medical) were used as controls. Each test circuit ran for 150 minutes at an output of 3 L/min, the circuit was then drained and the fluid collected. Quantitative analysis included weighing the dried filter paper and using particle size light scattering to quantify the particle size and count. Attenuated total reflectance spectroscopy was also used. ResultsEach of the three coated sheaths had significantly greater shedding compared with the control sheaths. The Cook Zenith alpha sheath had significantly more residue weight (2.87 ± 0.52 mg/L) than the Gore DrySeal (1.07 ± 0.06 mg/L) and Medtronic Sentrant introducer (0.98 ± 0.14 mg/L) sheaths. The average particle size was not significantly different between the coated and uncoated (control) sheaths. Attenuated total reflectance spectroscopy identified sheath particulate in the Cook Zenith Alpha and Medtronic Sentrant samples. ConclusionsPolymer embolization was present and significantly greater in all three commercially available hydrophilic sheaths compared with the control group. Further investigation is needed into the clinical significance of these findings.

Anatomical feasibility of fenestrated stent graft to treat complex abdominal aortic aneurysms from a Korean single institute database.

This study aims to investigate the feasibility of Zenith Fenestrated AAA Endovascular Graft (Z-FEN, Cook Medical) from a single Korean institution database by evaluating the vascular anatomy of Korean abdominal aortic aneurysm (AAA) patients with hostile aortic neck. This is a retrospective study on patients with AAA who underwent endovascular aortic repair (EVAR) and open surgery repair between January 2012 and December 2021 (n = 211). The anatomic characteristics of the aortic neck were evaluated using 3-dimensional reconstructed computed tomographic scans. For the juxtarenal AAA patients (n = 39), feasibility of fenestrated stent graft was evaluated under the protocol of fenestrated EVAR. For those who were not suitable for the application of Z-FEN, the reasons for unsuitability were analyzed. Among 211 AAA patients, 108 patients (51.2%) had complex aortic neck, and 39 (18.5%) had insufficient aortic neck length (<15 mm) for conventional EVAR. Of the 39 patients with juxtarenal AAAs, 13 (33.3%) were determined feasible for Z-FEN. Twenty-six patients (66.7%) were noncandidate for Z-FEN due to severe neck angulation, short aortic neck length, inadequate iliac artery anatomy, large aortic neck diameter, and severe calcification and thrombosis. Proximal aortic neck length of the non-feasible group was significantly shorter than that of the feasible group (P = 0.002). Z-FEN was applicable to 33.3% of the juxtarenal AAA patients. As recent studies confirm, the effectiveness and safety of fenestrated EVAR, Z-FEN can be an option for AAA patients with short aortic neck.

DYNAMIC CONTRAST-ENHANCED MRI OF THE SYNOVIUM IN KNEE OSTEOARTHRITIS: SEMI-AUTOMATIC SEGMENTATION OF SYNOVIAL SUBREGIONS AND TEST-RETEST REPEATABILITY

Inflammation of the joint lining (synovitis) is often seen in OA, and is strongly associated with both knee pain severity and disease progression. Dynamic contrast-enhanced MRI (DCE-MRI) can be used to visualize the uptake and washout of gadolinium-based contrast, and enables quantification of blood perfusion as a surrogate measure of inflammation. DCE-MRI could therefore be used to characterize the extent of synovitis and serve as a biomarker for response to treatment in clinical trials. However, (semi)-automatic segmentation methods and thorough technical and clinical validation are needed to fully adopt DCE-MRI in this setting. We aim to evaluate semi-automatic segmentation of synovial subregions and test-retest repeatability of DCE-MRI to measure synovial perfusion in patients with knee OA. Patients with mild-to-moderate knee OA (KLG 1-3) who were allocated to the control group in a prospective randomized controlled trial of genicular artery embolization were included. Patients underwent MRI at 3T (GE Healthcare) at baseline and after 1 month. Image acquisition consisted of native T1 mapping with variable flip angle, followed by a dual-echo SPGR sequence (DISCO; DIfferential Sub-sampling with Cartesian Ordering), in which the spatial resolution was optimized to allow for visualization of small vessels. After the initial phase, 0.1 ml/kg gadovist was injected and subsequently 34 dynamic phases were acquired, with a temporal resolution of 10.2 seconds. Segmentation of the synovium comprised an initial rough manual segmentation followed by selection of enhancing voxels using a shuffle transform method. Synovial subregions were created by semi-automatic vessel mapping using MeVisLab and mathematically assigning synovial voxels to the corresponding closest genicular artery. Motion compensation was performed using Elastix (Elastix, version 5.0.1), and native T1 mapping and pharmacokinetic modelling was done using open source software for DCE analysis (MADYM, version 4.21.1). The commonly used combination of the Parker literature arterial input function, and the Extended Toft's model pharmacokinetic model was implemented. Voxelwise perfusion parameters were calculated, after which median Ktrans values were extracted for the whole synovium and separately for each synovial subregion. Agreement was visualized with a Bland-Altman plot, and test-retest repeatability was evaluated using intraclass correlation coefficients (ICC; single rating random sample) and within-subject coefficients of variation (CV). 30 patients were included, of which two patients were lost to follow-up and one patient was excluded due to errors during image acquisition. For the remaining 27 participants, median Ktrans values ranged from 0.017 to 0.121. ICC of Ktrans for the whole synovium was 0.51, and CV was 0.14. Sensitivity analysis by exclusion of two statistical outliers yielded an ICC of 0.66 and a CV of 0.11. For the individual synovial regions, ICCs ranged between 0.27 and 0.58 while CVs ranged between 0.13 and 0.25. Semi-automatic segmentation of the synovium and synovial subregions through vessel mapping on DCE-MRI in knee OA is feasible. Perfusion parameters determined through pharmacokinetic modeling have moderate repeatability and should be interpreted with caution. Stichting Coolsingel, Cook Medical, Erasmus MRace Doelmatigheid E.H.G. Oei has received research support from GE Healthcare. The University of Wisconsin receives research support from Bracco Diagnostics. CORRESPONDENCE ADDRESS: [email protected]

Cook Medical Wire Guides

Cook Medical Wire Guides

ESHRE guideline: recurrent pregnancy loss: an update in 2022.

What are the updates for the recommended management of women with recurrent pregnancy loss (RPL) based on the best available evidence in the literature from 2017 to 2022? The guideline development group (GDG) updated 11 existing recommendations on investigations and treatments for RPL, and how care should be organized, and added one new recommendation on adenomyosis investigation in women with RPL. A previous ESHRE guideline on RPL was published in 2017 and needs to be updated. The guideline was developed and updated according to the structured methodology for development and update of ESHRE guidelines. The literature searches were updated, and assessments of relevant new evidence were performed. Relevant papers published between 31 March 2017 and 28 February 2022 and written in English were included. Cumulative live birth rate, live birth rate, and pregnancy loss rate (or miscarriage rate) were considered the critical outcomes. Based on the collected evidence, recommendations were updated and discussed until consensus was reached within the GDG. A stakeholder review was organized after the updated draft was finalized. The final version was approved by the GDG and the ESHRE Executive Committee. The new version of the guideline provides 39 recommendations on risk factors, prevention, and investigation in couples with RPL, and 38 recommendations on treatments. These includes 62 evidence-based recommendations-of which 33 were formulated as strong recommendations and 29 as conditional-and 15 good practice points. Of the evidence-based recommendations, 12 (19.4%) were supported by moderate-quality evidence. The remaining recommendations were supported by low (34 recommendations; 54.8%), or very low-quality evidence (16 recommendations; 25.8%). Owing to the lack of evidence-based investigations and treatments in RPL care, the guideline also clearly mentions those investigations and treatments that should not be used for couples with RPL. The guidelines have been updated; however, several investigations and treatments currently offered to couples with RPL have not been well studied; for most of these investigations and treatments, a recommendation against using the intervention or treatment was formulated based on insufficient evidence. Future studies may require these recommendations to be revised. The guideline provides clinicians with clear advice on best practice in RPL, based on the best and most recent evidence available. In addition, a list of research recommendations is provided to stimulate further studies in RPL. Still, the absence of a unified definition of RPL is one of the most critical consequences of the limited scientific evidence in the field. The guideline was developed and funded by ESHRE, covering expenses associated with the guideline meetings, with the literature searches and with the dissemination of the guideline. The guideline group members did not receive payment.O.B.C. reports being a member of the executive board of the European Society for Reproductive Immunology and has received payment for honoraria for giving lectures about RPL in Australia in 2020. M.G. reports unconditional research and educational grant received by the Centre for Reproductive Medicine, Amsterdam UMC from Guerbet, Merck and Ferring, not related to the presented work. S.L. reports position funding from EXAMENLAB Ltd. and ownership interest by stock or partnership of EXAMENLAB Ltd (CEO). S.Q. reports being a deputy director of Tommy's National centre for miscarriage research, with payment received by the institution for research, staff time, and consumables for research. H.S.N. reports grants with payment to institution from Freya Biosciences ApS, Ferring Pharmaceuticals, BioInnovation Institute, the Danish ministry of Education, Novo Nordic Foundation, Augustinus Fonden, Oda og Hans Svenningsens Fond, Demant Fonden, Ole Kirks Fond, and Independent Research Fund Denmark and speakers' fees for lectures from Ferring Pharmaceuticals, Merck A/S, Astra Zeneca, IBSA Nordic and Cook Medical. She also reports to be an unpaid founder and chairman of a maternity foundation. M.-L.v.d.H. received small honoraria for lectures on RPL care. The other authors have no conflicts of interest to declare. This guideline represents the views of ESHRE, which were achieved after careful consideration of the scientific evidence available at the time of preparation. In the absence of scientific evidence on certain aspects, a consensus between the relevant ESHRE stakeholders has been obtained.Adherence to these clinical practice guidelines does not guarantee a successful or specific outcome, nor does it establish a standard of care. Clinical practice guidelines do not replace the need for application of clinical judgment to each individual presentation, nor variations based on locality and facility type.ESHRE makes no warranty, express or implied, regarding the clinical practice guidelines and specifically excludes any warranties of merchantability and fitness for a particular use or purpose. (Full disclaimer available at www.eshre.eu/guidelines.).

Current Trends in Endoscopic Ear Surgery.

Current Trends in Endoscopic Ear Surgery.

Efficacy and safety of the extraction of cardiostimulation leads using a mechanical dissection tool. A single center experience.

The percutaneous extraction of endovascular cardiostimulation and defibrillation leads is the most frequent technique nowadays. The tools used today must guarantee the success of the procedure, with the minimum of complications. Our objective was to analyze the safety and efficacy of lead extraction using the Evolution mechanical dissection tool (Cook Medical, USA). A retrospective study was carried out in a total of 826 consecutive patients from October 2009 to December 2018 who underwent the procedure with the Evolution mechanical dissection tool. Preoperative study included complete blood tests, echocardiogram, and chest X-ray. The procedures were performed in the operating room, under general anesthesia and echocardiographic control. A total of 1227 leads were extracted with a mean chronicity of 10.3±5.1 years. Clinical success (CS) rate was 99.7%. A total of 16 (1.9%) complications occurred, 2 (0.24%) were major complications and 14 (1.7%) were minor complications. There was no operative mortality. There was no statistically significant relationship between implant chamber and complete efficacy. The complete extraction was achieved in all left ventricular leads, in 762 of 774 (98.45%) of right ventricular lead removal, and in 330 of 334 (98.8%) of right atrial leads (p=.31). In our experience, percutaneous extraction of intravenous leads via the use of the Evolution tool (Cook Medical, USA), is a very effective and safe technique that offers low morbidity and mortality.

Reconstruction of upper extremity and thoracic central veins using dedicated venous stents: Implantation of 75 stents in 46 patients

Dedicated self-expanding bare-metal venous stents, including Abre (Medtronic; Dublin, Ireland), Venovo (Becton, Dickinson, and Company; Franklin Lakes, NJ), Vici (Boston Scientific; Marlborough, MA), and Zilver Vena (Cook Medical; Bloomington, IN), are approved for the treatment of iliofemoral venous occlusive disease.1–4 This report describes the use of these venous stents in the upper extremity and thoracic central veins. Institutional review board approval was obtained for preparation of this report.

Outcomes of Directional Branches of the T-Branch Off-the-Shelf Multi-Branched Stent-Graft.

A controversy on bridging covered stent (BCS) choice, between self-expanding (SECS) and balloon-expandable (BECS) stents, still exists in branched endovascular repair. This study aimed to determine the primary target vessel (TV) patency in patients treated with the t-Branch device and identify factors impairing the outcomes. A retrospective study was undertaken, including patients treated with the t-Branch (Cook Medical, Bloomington, IN, USA) between 2014 and 2019 (early 2014-2016; late 2017-2019). The endpoint was the primary patency (CT: celiac trunk, SMA, superior mesenteric artery, RRA: right renal artery, LRA: left renal artery) during the follow-up. Any branch instability event was assessed. The factors affecting the patency were determined using multivariable regression models and Kaplan-Meier analyses. In total, 2018 TVs were analyzed; 1542 SECSs and 476 BECSs. The CT patency was 99.8% (SE 0.2%) at the 1st month, with no other event. The SMA patency was 97.8% (SE 1) at the 12th month. The RRA patency was 96.7% (SE 2) at the 24th month. The LRA patency was 99% (SE 0.4) at the 6th month. Relining was the only factor independently associated with the SMA patency (OR 8.27; 95% CI 1.4-4.9; p = 0.02). The freedom from instability was 62% (SE 4.3%) and 45% (SE 5.4%) at the 24th month and 36th month. No significant difference was identified between the BECSs and SECSs in the early or late experience. BCS for the t-Branch branches performed with a good primary patency during the short-term follow-up. The type of BCS did not influence the patency. Relining might be protective for SMA patency.

Reintervention does not affect long-term survival after fenestrated endovascular aneurysm repair.

Fenestrated endovascular aneurysm repair (FEVAR) is increasingly used in the treatment of juxtarenal aortic aneurysms and short-neck infrarenal aneurysms. Reinterventions (REIs) occur frequently, contributing to patient morbidity and resource utilization. We sought to determine whether REI affects long-term survival after FEVAR. A single-institution retrospective review of all Cook Zenith fenestrated (ZFEN; Cook Medical, Inc, Bloomington, IN) repairs was performed. Patients with ≥6months of follow-up and without adjunctive branch modifications were included. REI was defined as any aneurysm, device, target branch, or access-related intervention after the index procedure. REIs were categorized as early (<30days) or late (≥30days), by indication (ie, branch, endoleak, limb related, access related, other), and by target branch or device components. Patients were stratified into REI vs no REI groups and branch REI vs non-branch REI groups. Of 219 consecutive ZFEN repairs from 2012 to 2021, 158 patients met the inclusion criteria. Of these 158 patients, 41 (26%) required a total of 51 REIs (10 early and 41 late) during a mean follow-up of 33.9months. The most common indication for REI was branch-related (31 of 51; 61%), with the renal arteries the most frequently affected (26 of 51; 51%). The only differences found in baseline, aneurysm, and device characteristics were a higher mean Society for Vascular Surgery comorbidity score (9.6 vs 7.9; P= .04) and larger suprarenal neck angle (23.3° vs 17.1°; P= .04) in the no REI group. In contrast, the REI group had a larger mean proximal seal zone diameter (26.3mm vs 25.1mm; P= .03) and device diameter (31.9mm vs 30.0mm; P= .002) compared with the no REI group. Technical success and operative characteristics were similar between the groups, except for a longer mean fluoroscopy time (74.9minutes vs 60.8minutes; P= .01) and longer median length of stay (2 vs 2days; P= .006) for the REI group. Although the rate of early (<30days) major adverse events was greater for the REI group (24.4% vs 6.0%; P= .001), the difference in 30-day mortality was not statistically significant (4.9% vs 0.9%; P= .10). On Kaplan-Meier analysis, freedom from REI at 1 and 5years was 85.7% and 62.6%, respectively, for the overall cohort. No difference was found in the estimated 5-year survival between the REI and no REI groups (62.8% vs 63.5%; log-rank, P= .87) and branch REI and non-branch REI groups (71.8% vs 49.9%; log-rank, P= .16). On multivariate analysis, REI was not an independent predictor for mortality. However, age, Society for Vascular Surgery comorbidity score, and preoperative maximum aneurysm diameter each increased the hazard of death (hazard ratio [HR], 1.07; 95% confidence interval [CI], 1.02-1.12 [P= .007]; HR, 1.10; 95% CI, 1.01-1.18 [P= .02]; HR, 1.05; 95% CI, 1.02-1.08 [P= .003], respectively). After ZFEN, 41 patients (26%) had required a total of 51 REIs, with most occurring ≥30days after the index procedure, and 61% were branch related, with no influence on 5-year survival. Age, comorbidity, and baseline aneurysm diameter independently predicted mortality. The use of FEVAR mandates lifelong surveillance and protocols to maintain branch patency. Despite their relative frequency, REIs did not influence 5-year postprocedural survival.

Limb graft occlusion after endovascular aneurysm repair with the Cook Zenith Alpha abdominal graft

ObjectivePrior reports of the low profile Zenith Alpha abdominal graft (Cook Medical Inc, Bloomington, IN) have shown impaired limb graft patency to be the primary causes of reintervention. Special notices from the manufacturer have indicated certain instructions for use (IFU) violations as the main reasons for these complications. In the present study, we assessed the incidence of limb graft occlusion (LGO) and analyzed the effects of the detailed anatomic risk factors for LGO highlighted in the IFU and previously reported studies. MethodsA retrospective study was performed of 241 patients treated with the low profile Zenith Alpha at a single institution from October 1, 2015 to September 30, 2018. All computed tomography angiograms were analyzed using three-dimensional software. Data were extracted from the electronic medical records until the end of the study period (December 31, 2020). The cumulative incidence of LGO and LGO-related reinterventions were assessed. A regression analysis was performed to evaluate the possible risk factors associated with the development of LGO at specified time points. These included aortic and iliac diameters, graft component oversizing, iliac tortuosity and calcification, overlap of graft components, proximal alignment of ipsilateral and contralateral legs, and sealing zone in the external iliac artery. Reader agreement of iliac calcification and tortuosity was assessed in patients with LGO. ResultsA total of 33 limbs (7%) in 27 patients (11%) had become occluded. The cumulative incidence of LGO was 7% (95% confidence interval [CI], 5%-9%) per limb up to 3 years postoperatively. The previously described risk factors for LGO were studied using regression analysis; however, no positive association with LGO was identified. Heavily calcified common iliac arteries (CIAs) and external iliac arteries were protective against LGO compared with noncalcified vessels up to 3 years postoperatively (decreased risk, 17% [95% CI, −27% to −7%]; P = .001; and 15% [95% CI, −26 to −5]; P = .005, respectively). The reader agreement of iliac calcification and tortuosity showed substantial agreement (CIA intrareader kappa = 0.75; CIA interreader kappa = 0.62) and almost perfect agreement (intrareader kappa = 0.85; interreader kappa = 0.84), respectively. ConclusionsThe cumulative incidence of LGO after endovascular aneurysm repair with the Zenith Alpha graft was 7% per limb up to 3 years postoperatively. None of the analyzed risk factors suggested by the IFUs or current literature were positively associated with LGO.

Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study

ObjectiveTo evaluate long term outcomes (reintervention and late rupture of abdominal aortic aneurysm) of aortic endografts in real world practice using linked registry claims data.DesignObservational surveillance study.Setting282 centers in the...

Evaluation of factors associated with limb thrombus formation after endovascular aortic aneurysm repair

BackgroundLimb thrombus formation is a complication that can occur after endovascular aortic repair (EVAR), and its clinical significance has continued to be debated. Our objective was to report the incidence of limb thrombus after EVAR and determine the association of specific demographic, anatomic, and/or graft variables. MethodsA retrospective analysis of EVAR patients at a single tertiary center between January 2010 and December 2018 was performed to determine the limb thrombus rate. Demographic, graft, and anatomic variables were analyzed for an association with limb thrombus. ResultsA total of 301 patients were included. The average follow-up was 27.6 ± 4.9 months. The mean age was 76.5 ± 0.5 years, and 85% were men. Limb thrombus occurred in 22 patients (7.3%). Of these 22 patients, 11 (50.0%) had had occlusive limb thrombus, 14 (63.6%) were symptomatic, and 17 (77.3%) had required intervention. The patients with limb thrombus were younger (69.8 ± 1.3 years vs 77.1 ± 0.5 years; P < .0001) and more likely to be smokers (10.2% vs 5.2%; P = .10). The incidence of limb thrombus with the Alpha graft (10.7%; Cook Medical Inc, Bloomington, IN) was compared with that with non-Cook grafts (4.0%; P = .07). The average common iliac artery diameter for patients with and without limb thrombus was 14.1 mm and 16.1 mm, respectively (P < .01). Right-sided limb thrombus was more likely in smaller right iliac arteries (14.7 ± 0.9 cm vs 17.0 ± 0.6 cm; P < .05), with a similar finding on the left (13.6 ± 0.9 cm vs 15.2 ± 0.4 cm; P = .13). Unilateral limb thrombus was almost twice as likely on the main body side than on the contralateral side (11 vs 6). Limb thrombus was not associated with aortoiliac disease (odds ratio [OR], 1.31; 95% confidence interval [CI], 0.37-4.62), limb extension (OR, 0.47; 95% CI, 0.06-3.62), or nonmatching limb heights (OR, 1.36; 95% CI, 0.54-3.43). Limb thrombus was also not associated with increased 30-day mortality (P > .05). ConclusionsLimb thrombus formation is a complication that can occur after EVAR (7.3%). In our study, limb thrombus was seen more frequently in younger patients and those who smoked. Cook Alpha grafts had a thrombus formation rate of 10.7%, which was not significantly higher than that with other brands. Limb thrombus was more likely in smaller iliac arteries and on the main body side.

Cloud-based fusion imaging improves operative metrics during fenestrated endovascular aneurysm repair

ObjectiveEndovascular treatment of complex aortic pathology has been associated with increases in procedural-related metrics, including the operative time and radiation exposure. Three-dimensional fusion imaging technology has decreased the radiation dose and iodinated contrast use during endovascular aneurysm repair. The aim of the present study was to report our institutional experience with the use of a cloud-based fusion imaging platform during fenestrated endovascular aneurysm repair (FEVAR). MethodsA retrospective review of a prospectively maintained aortic database was performed to identify all patients who had undergone FEVAR with commercially available devices (Zenith Fenestrated; Cook Medical Inc, Bloomington, IN) between 2013 and 2020 and all endovascular aneurysm repairs performed using Cydar EV Intelligent Maps (Cydar Medical, Cambridge, UK). The Cydar EV cohort was reviewed further to select all FEVARs performed with overlay map guidance. The patient demographic, clinical, and procedure metrics were analyzed, with a comparative analysis of FEVAR performed without and with the Cydar EV imaging platform. Patients were excluded from comparative analysis if the data were incomplete in the dataset or they had a documented history of prior open or endovascular abdominal aortic aneurysm repair. ResultsDuring the 7-year study period, 191 FEVARs had been performed. The Cydar EV imaging platform was implemented in 2018 and used in 124 complex endovascular aneurysm repairs, including 69 consecutive FEVARs. A complete dataset was available for 137 FEVARs. With exclusion to select for de novo FEVAR, a comparative analysis was performed of 53 FEVAR without and 63 with Cydar EV imaging guidance. The cohorts were similar in patient demographics, medical comorbidities, and aortic aneurysm characteristics. No significant difference was noted between the two groups for major adverse postoperative events, length of stay, or length of intensive care unit stay. The use of Cydar EV resulted in nonsignificant decreases in the mean fluoroscopy time (69.3 ± 28 minutes vs 66.2 ± 33 minutes; P = .598) and operative time (204.4 ± 64 minutes vs 186 ± 105 minutes; P = .278). A statistically significant decrease was found in the iodinated contrast volume (105 ± 44 mL vs 83 ± 32 mL; P = .005), patient radiation exposure using the dose area product (1,049,841 mGy/cm2 vs 630,990 mGy/cm2; P < .001) and cumulative air kerma levels (4518 mGy vs 3084 mGy; P = .02) for patients undergoing FEVAR with Cydar EV guidance. ConclusionsAt our aortic center, we have observed a trend toward shorter operative times and significant reductions in both iodinated contrast use and radiation exposure during FEVAR using the Cydar EV intelligent maps. Intelligent map guidance improved the efficiency of complex endovascular aneurysm repair, providing a safer intervention for both patient and practitioner.

Comparison of Physical Perturbation Devices for Enhancing Lentiviral Vector-Mediated Gene Transfer to the Airway Epithelium.

Natural airway defenses currently impede the efficacy of viral vector-mediated airway gene therapy. Conditioning airways before vector delivery can disrupt these barriers, improving viral vector access to target receptors and airway stem cells. This study aimed to assess and quantify the in vivo histological and gene transfer effects of physical perturbation devices to identify effective conditioning approaches. A range of flexible wire baskets with varying configurations, a Brush, biopsy forceps, and a balloon catheter were examined. We first evaluated the histological effects of physical perturbation devices in rat tracheas that were excised 10 min after conditioning. Based on the histological findings, a selection of devices was used to condition rat tracheas in vivo before delivering a lentiviral vector containing the LacZ reporter gene. After 7 days, excised tracheas were X-gal processed and examined en face to quantify the area of LacZ staining. Histological observations 10 min after conditioning found that physical perturbation dislodged cells from the basement membrane to varying degrees, with some producing significant levels of epithelial cell removal. When a subset of devices was assessed for their ability to enhance gene transfer, only the NGage® wire basket (Cook Medical) produced a significant increase in the proportion of X-gal-stained area when compared with unconditioned tracheas (eightfold, p = 0.00025). These results suggest that a range of factors contribute to perturbation-enhanced gene transfer. Overall, this study supports existing evidence that physical perturbation can assist airway gene transfer and will help to identify the characteristics of an effective device for airway gene therapy.