scholarly journals Pipeline Flex embolisation device with Shield Technology for the treatment of patients with intracranial aneurysms: periprocedural and 6 month outcomes

2020 ◽  
Vol 33 (6) ◽  
pp. 471-478
Author(s):  
James Yeomans ◽  
Lilian Sandu ◽  
Anand Sastry

Background and purpose The Pipeline Flex embolisation device with Shield Technology (Pipeline Shield) is a novel flow diverter which reduces intra-vessel thrombogenicity. This study summarises periprocedural outcomes and 6-month follow-up results following its introduction in a tertiary interventional neuroradiology centre. Materials and methods This prospective, single-arm study assessed 32 aneurysms treated over a 21-month time period from the time of procedure to 6 months post-procedure. Data collected included patient demographics, aneurysm features and intraprocedural and 6-month post-procedural complications. Results The mean age of the cohort was 58.8 ± Standard Deviation 8.5 years. Twenty-eight aneurysms were treated electively and four acutely. The elective cases received dual antiplatelet therapy post-procedure. The acute cases received single antiplatelet therapy post-procedure. Of the target aneurysms, 16/32 (50%) were small (<10 mm), 13/32 (41%) were large (10–25 mm) and 3/32 (9%) were giant (≥25 mm). There was no mortality in the series. There were two periprocedural complications (2/32, 6.2%): a stroke and a dissection. There were no post-procedural complications. At 6 months post-procedure, satisfactory occlusion (defined as Raymond–Roy 1 or 2) was achieved in 90.6% and 93.8% by way of magnetic resonance angiography and digital subtraction angiography assessment, respectively. There was no implant migration, no significant intraluminal hyperplasia or in-stent stenosis and no cases of aneurysm recurrence. Conclusion The Pipeline Shield has an excellent 6- month safety profile with an acceptable rate of intraprocedural complications, no post-procedure complications and no mortality in this case series of 32 acute and elective cases.

2021 ◽  
pp. 159101992110118
Author(s):  
J Yeomans ◽  
A Sastry

Background/Purpose pCONUS 2 and pCONUS 2-HPC are novel neck-bridging devices designed to support endovascular coil occlusion of wide-necked intracranial bifurcation aneurysms. This study summarises periprocedural outcomes, 6-month, and early 2-year follow-up results following its introduction in an interventional neuroradiology centre. Materials/Methods This prospective, single-arm study assessed 20 aneurysms treated over a 40 month time period from time of procedure to 2 years post-procedure. Data collected included patient demographics, aneurysm features, and intraprocedural, 6-month, and 2-year post-procedural complications and angiographic features. Results The mean age of the cohort was 59+-SD 7.7 years. 16 unruptured aneurysms were treated (pCONUS 2 13/16, pCONUS 2-HPC 3/16) and 4 ruptured aneurysms were treated with pCONUS 2-HPC. Unruptured cases received dual antiplatelet therapy pre- and post-procedure while ruptured cases received single antiplatelet therapy. 9/20 aneurysms were located at the MCA bifurcation and 7/20 at the basilar tip. The remaining 4 aneurysms were at various bifurcations in the anterior circulation. 11/20 were small (<10mm) and 9/20 were large (10–25mm). There was one periprocedural complication: a retroperitoneal bleed. There were no post-procedural intracranial complications or at 6-months follow-up. At 6 months, satisfactory occlusion was achieved in 94% of cases (15/16). There was one delayed death at 2-year follow-up from an unrelated cause. Conclusion pCONUS 2 and pCONUS 2-HPC have excellent short and medium-term safety profiles and clinical outcomes with no procedure-related mortality or morbidity and good occlusion rates at 6-month follow-up. The use of pCONUS 2-HPC with single antiplatelet therapy is feasible and did not cause any complications.


2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
E Lau ◽  
Z Arshad ◽  
A Aslam ◽  
A Thahir ◽  
M Krkovic

Abstract Introduction Osteomyelitis refers to an inflammatory process affecting bone and bone marrow. This study reviews chronic femoral osteomyelitis treatment and outcomes, including economic impact. Method We retrospectively collected data from a consecutive series of 14 chronic femoral osteomyelitis patients treated between January 2013 and January 2020. Data collected include patient demographics, comorbidities, pathogens, complications, treatment protocol and costs. Functional outcome was assessed using EuroQOL five-dimensional interview administration questionnaire (EQ-5D-5L™) and EuroQOL Visual Analogue Scale (EQ-VAS™). Results Of these, 92.9% had one or more osteomyelitis risk factor, including smoking and diabetes. Samples from 78.6% grew at least one pathogen. Only 42.9% achieved remission after initial treatment, but 85.7% were in remission at final follow-up, with no signs of recurrence throughout the follow-up period (mean: 21.4 months). The average treatment cost was £39,249.50 with a net mean loss of £19,080.10 when funding was considered. The mean-derived EQ-5D score was 0.360 and the mean EQ-VAS score was 61.7, lower than their values for United Kingdom’s general population, p = 0.0018 and p = 0.013 respectively. Conclusions Chronic femoral osteomyelitis treatment is difficult, resulting in significant economic burden. With previous studies showing cheaper osteomyelitis treatment at specialist centres, our net financial loss incurred suggests the need for management at specialised centres.


2021 ◽  
Author(s):  
Serge Marbacher ◽  
Matthias Halter ◽  
Deborah R Vogt ◽  
Jenny C Kienzler ◽  
Christian T J Magyar ◽  
...  

Abstract BACKGROUND The current gold standard for evaluation of the surgical result after intracranial aneurysm (IA) clipping is two-dimensional (2D) digital subtraction angiography (DSA). While there is growing evidence that postoperative 3D-DSA is superior to 2D-DSA, there is a lack of data on intraoperative comparison. OBJECTIVE To compare the diagnostic yield of detection of IA remnants in intra- and postoperative 3D-DSA, categorize the remnants based on 3D-DSA findings, and examine associations between missed 2D-DSA remnants and IA characteristics. METHODS We evaluated 232 clipped IAs that were examined with intraoperative or postoperative 3D-DSA. Variables analyzed included patient demographics, IA and remnant distinguishing characteristics, and 2D- and 3D-DSA findings. Maximal IA remnant size detected by 3D-DSA was measured using a 3-point scale of 2-mm increments. RESULTS Although 3D-DSA detected all clipped IA remnants, 2D-DSA missed 30.4% (7 of 23) and 38.9% (14 of 36) clipped IA remnants in intraoperative and postoperative imaging, respectively (95% CI: 30 [ 12, 49] %; P-value .023 and 39 [23, 55] %; P-value = &lt;.001), and more often missed grade 1 (&lt; 2 mm) clipped remnants (odds ratio [95% CI]: 4.3 [1.6, 12.7], P-value .005). CONCLUSION Compared with 2D-DSA, 3D-DSA achieves a better diagnostic yield in the evaluation of clipped IA. Our proposed method to grade 3D-DSA remnants proved to be simple and practical. Especially small IA remnants have a high risk to be missed in 2D-DSA. We advocate routine use of either intraoperative or postoperative 3D-DSA as a baseline for lifelong follow-up of clipped IA.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Y Oishi ◽  
T Shinke ◽  
H Tanaka ◽  
K Ogura ◽  
K Arai ◽  
...  

Abstract Background Recent clinical study suggests newer-generation drug-eluting stents (DES) that combine ultrathin strut and nano-coating with biodegradable polymers sirolimus-eluting stent (BP-SES) could improve long-term clinical outcomes in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) over current generation DES. However, safety profiles in very early phase have not been systematically addressed. Objective and method We exploratory investigate early vascular response following BP-SES implantation in patients with STEMI to reveal mechanism of the favorable clinical outcomes in recent studies using frequency domain-optical coherence tomography (FD-OCT). Consecutive twenty patients with STEMI who underwent FD-OCT immediately after primary PCI and were eligible for follow-up FD-OCT at 2 weeks after implantation were enrolled between June 2018 and November 2019. Results Twenty patients (age 62.7±11.3 years, male 85.0%) were enrolled with frequencies of hypertension (45.0%), diabetes mellitus (35.0%), dyslipidemia (55.0%) and smoking (80.0%). Aspiration catheter were used in all patients, and 1.13±0.34 stents were used. Only one patient (5.0%) received chronic antiplatelet therapy with aspirin prior to the onset of STEMI. All patients started to receive prasugrel as thienopyridine from this event and continued dual antiplatelet therapy for 2 weeks. The percentage of uncovered struts significantly decreased from post-procedure to 2W follow-up (69±18% post-procedure versus 30±11% at 2W follow up, p&lt;0.0001). Malapposed struts also decreased (5.6±5.7% post-procedure versus0.9±1.2% at 2W follow up, p&lt;0.0001).The average protrusion area of athero-thrombotic burden numerically decreased (0.37±0.19 at post-procedure versus 0.34±0.14 mm2 at 2W follow up, p=0.19) and its volume showed similar tendency (10.60±6.40 at post-procedure versus 9.36±5.14 mm3 at 2W follow up, p=0.19). Conclusion(s) This study firstly elucidated very early vascular responses following ultrathin strut BP-SES implantation in STEMI patients, showing early progression of strut coverage and resolution of athero-thrombotic materials. This technology may have a potential to overcome the current generation DESs in this clinical setting. Thrombus, uncovered and malapposed struts Funding Acknowledgement Type of funding source: None


2021 ◽  
pp. 159101992110295
Author(s):  
Pervinder Bhogal ◽  
Andrey Petrov ◽  
Ganbaatar Rentsenkhu ◽  
Baatarjan Nota ◽  
Erdenebat Ganzorig ◽  
...  

Background The p64MW HPC and p48MW HPC flow diverters have reduced thrombogenicity due to hydrophilic coating. The purpose of this study was to evaluate its safety and efficacy in Mongolian patients under single antiplatelet therapy (SAPT) with prasugrel. Materials and methods We performed a retrospective review of patients enrolled into our prospectively maintained database to identify all patients treated with either the p48MW HPC or p64MW HPC under SAPT. We recorded baseline demographics, aneurysm size and location, procedural complications, angiographic and clinical results. Results 24 patients, (female = 21, 87.5%), age 48.2 ± 11.6 years (range 25–63) underwent treatment of 30 aneurysms with either p64MW HPC or p48MW HPC. All aneurysms were saccular with dome width 8.2 ± 6.5 (range 1.6–26.0 mm) and dome height 7.6 ± 6.7 (range 1.6–30.0 mm). None of the aneurysms were previously treated. The average PRU was 54.6 ± 31.2 (range 1–127) on pre-operative VerifyNow testing. Angiographic follow-up was available for 13 patients (17 aneurysms), 183 ± 36 days post-procedure, at which point 64.7% of aneurysms (n = 11/17) were completely occluded and 11.8% (n = 2/17) had only neck remnants resulting in 76.5% of aneurysms being adequately occluded A single intra-operative complication (4.2%) occurred however all patients were mRS ≤1 at last follow-up. There were two post-operative complications neither of which resulted in permanent neurological morbidity. There were no instances of post-operative aneurysmal rupture or delayed parenchymal haemorrhage. The overall mortality was 0%. Conclusion The efficacy and safety of p64MW HPC coated devices under SAPT is similar to uncoated flow diverters that require DAPT.


2018 ◽  
Vol 28 (4) ◽  
pp. 395-400 ◽  
Author(s):  
Ronald H. M. A. Bartels ◽  
Jan Goffin

Anterior cervical discectomy with fusion (ACDF) is a very well-known and often-performed procedure in the practice of spine surgeons. The earliest descriptions of the technique have always been attributed to Cloward, Smith, and Robinson. However, in the French literature, this procedure was also described by others during the exact same time period (in the 1950s).At a meeting in Paris in 1955, Belgians Albert Dereymaeker and Joseph Cyriel Mulier, a neurosurgeon and an orthopedic surgeon, respectively, described the technique that involved an anterior cervical discectomy and the placement of an iliac crest graft in the intervertebral disc space. In 1956, a summary of their oral presentation was published, and a subsequent paper—an illustrated description of the technique and the details of a larger case series with a 3.5-year follow-up period—followed in 1958.The list of authors who first described ACDF should be completed by adding Dereymaeker’s and Mulier’s names. They made an important contribution to the practice of spinal surgery that was not generally known because they published in French.


2019 ◽  
Vol 161 (1) ◽  
pp. 164-170 ◽  
Author(s):  
Lyndy J. Wilcox ◽  
Claudia Schweiger ◽  
Catherine K. Hart ◽  
Alessandro de Alarcon ◽  
Nithin S. Peddireddy ◽  
...  

ObjectiveThis study documents the growth and course of repaired complete tracheal rings over time after slide tracheoplasty.Study DesignCase series with review.SettingTertiary pediatric academic medical center.Subjects/MethodsMedical records of pediatric patients with confirmed tracheal rings on bronchoscopy who underwent slide tracheoplasty between January 2001 and December 2015 were reviewed. Patients who had operative notes documenting tracheal sizing over time were included. Exclusion criteria included tracheal stenosis not caused by complete tracheal rings, surgical repair prior to presentation at our institution, or lack of adequate sizing information. The postoperative follow-up was examined and airway growth over time documented.ResultsOf 197 slide tracheoplasties performed during the study time period, 139 were for complete tracheal rings, and 40 of those children met inclusion criteria. The median age at time of surgery was 7 months, and the median initial airway size was 3.9 mm (n = 34). The median growth postoperatively was 1.9 mm over a median follow-up period of 57 months (0.42 mm/year), which is similar to growth rates of unrepaired complete tracheal rings ( P = .53). Children underwent a median of 10 postoperative endoscopies, with time between endoscopies increasing further out from surgery. The most commonly performed adjunctive procedure was balloon dilation.ConclusionsThis is the first study documenting continued growth of repaired complete tracheal rings after slide tracheoplasty. Postoperative endoscopic surveillance ensures adequate growth. Intervals between airway endoscopies can be increased as the child gets older, as the airway increases in size, and as long as symptoms are minimal.


2019 ◽  
Vol 104 (2) ◽  
pp. 167-172 ◽  
Author(s):  
Lauren A Dalvin ◽  
Michael D Yu ◽  
David Arturo Ancona-Lezama ◽  
Jose S Pulido ◽  
Timothy W Olsen ◽  
...  

AimsTo investigate the association of peripheral retinal non-perfusion with retinal haemangioblastoma.MethodsMedical and widefield fluorescein angiography records of patients diagnosed with retinal haemangioblastoma from 1990 to 2018 were reviewed for patient demographics, tumour features, fluorescein angiography features and characteristics of peripheral retinal non-perfusion.ResultsThere were 41 eyes of 40 patients with retinal haemangioblastoma imaged by widefield fluorescein angiography during this time period. Of 41 eyes, 14 (34%) had haemangioblastoma-associated peripheral retinal non-perfusion on fluorescein angiography. A comparison of eyes with versus without non-perfusion revealed younger mean age at presentation (28 vs 43 years old, p=0.05), increased prevalence of von Hippel-Lindau (VHL) disease (62% vs 22%, p=0.01), greater mean largest tumour basal diameter (3.7 vs 2.5 mm, p=0.04), greater tumour distance from optic nerve (8.4 vs 1.9 mm, p<0.01) and increased prevalence of vascular leakage from the tumour (86% vs 52%, p=0.03). After mean follow-up of 97 versus 71 months (p=0.52), eyes with non-perfusion were significantly more likely to develop neovascularisation (40% vs 0%, p<0.01) and experience a three-line or greater decrease in visual acuity (60% vs 11%, p<0.01).ConclusionPeripheral retinal non-perfusion can be associated with retinal haemangioblastoma, and could be more common with larger, more peripheral tumours in younger patients with VHL disease. Eyes with haemangioblastoma-associated peripheral non-perfusion could be more likely to develop neovascularisation and lose visual acuity.


2018 ◽  
Vol 17 (5) ◽  
pp. 0-10
Author(s):  
John Romano ◽  
Charles V. Welden ◽  
Jordan Orr ◽  
Brendan McGuire ◽  
Mohamed Shoreibah

Parastomal variceal bleeding (PVB) is a serious complication occurring in up to 27% of patients with an ostomy and concurrent cirrhosis and portal hypertension. The management of PVB is difficult and there are no clear guidelines on this matter. TIPS, sclerotherapy, and /or coil embolization are all therapies that have been shown to successful manage PVB. We present a case series with five different patients who had a PVB at our institution. The aim of this case series is to report our experience on the management of this infrequently reported but serious condition. We also conducted a systemic literature review focusing on the treatment modalities of 163 patients with parastomal variceal bleeds. In our series, patient 1 had embolization and sclerotherapy without control of bleed and expired on the day of intervention due to hemorrhagic shock. Patient 2 had TIPS in conjunction with embolization and sclerotherapy and had no instance of rebleed 441 days after therapy. Patient 3 did not undergo any intervention due to high risk for morbidity and mortality, the bleed self-resolved and there was no further rebleed, this same patient died of sepsis 73 days later. Patient 4 had embolization and sclerotherapy and had no instance of rebleed 290 days after therapy. Patient 5 had TIPS procedure and was discharged five days post procedure without rebleed, patient has since been lost to follow-up.


2021 ◽  
Vol 12 ◽  
Author(s):  
Vladimir Gavrilovic ◽  
Annarita Dapoto ◽  
Nicola Marotti ◽  
Andrea Pellegrin ◽  
Alessandro Pauro ◽  
...  

Background and Purpose: Flow diverting stents are designed to divert blood flow from the aneurysm sac, allowing for eventual occlusion following endovascular therapy. This case series reports clinical experience using the Silk Vista Baby (SVB, Balt Extrusion, Montmorency, France), a flow diverter (FD) designed to treat intracranial aneurysms in small, distal vessels.Methods: All patients who underwent treatment with SVB at the University Hospital “Santa Maria della Misericordia” of Udine between July 2018 and September 2020 were retrospectively identified. Baseline patient and aneurysm characteristics, intraprocedural technical outcomes, periprocedural complications, modified Rankin Scale (mRS) at discharge, magnetic resonance imaging (MRI) results at 3-month follow-up, and angiographic results at 6-month follow-up were collected.Results: A total of 18 patients (55.6% [10/18] male; mean age 62.6 years, range: 42–77 years) were retrospectively identified, receiving treatment for 22 aneurysms. Most patients were symptomatic (14/18, 77.8%) and approximately half had subarachnoid hemorrhage (10/18, 55.6%). Sufficient aneurysm coverage was achieved in 88.9% (16/18) of patients with a single device. Mortality did not occur (0/18, 0%); adverse device-related events included side branch occlusion (1/18, 5.6%) and in-stent thrombosis (1/18, 5.6%). At discharge, 77.8% (14/18) had an mRS of 0. In most cases, patients showed complete occlusion (10/15, 66.7%) or a small aneurysmal remnant (3/15, 20.0%) upon MRI; upon angiography, most showed complete occlusion (10/13, 76.9%) or only a small aneurysmal remnant (2/13, 15.4%).Conclusion: This case series showed that the SVB FD is safe and feasible to use in patients with aneurysms in small, distal vessels. Additional randomized, prospective studies with larger cohorts are needed for the SVB.


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