scholarly journals Safety of Occlutech Septal Occluder ACCELL Flex II for Transcatheter Closure of Secundum Atrial Septal Defects in Children: A Long-Term Follow-Up

2022 ◽  
Vol 2022 ◽  
pp. 1-6
Author(s):  
Amal M. El-Sisi ◽  
Sonia A. El-Saiedi ◽  
Rasha Ammar ◽  
Asmaa Abdelhameed ◽  
Ziyad M. Hijazi ◽  
...  

Objectives. To assess the long-term safety and efficacy of the Occlutech® ACCELL® Flex II device used for atrial septal defect (ASD) closure. This device differs from the regular device by having two very thin patches that are made of polyethylene terephthalate (PET). These patches enhance faster sealing of the defect. Background. Transcatheter closure has become the method of choice to manage most patients with secundum ASDs. There are different types of devices. The regular Occlutech device used to close an ASD is called the Occlutech Figulla Flex II. A newer modification of this device (Occlutech® ACCELL® Flex II) has been designed to eliminate/reduce thrombus formation and to enhance faster sealing. Methods. Thirty patients were followed up after occlusion of secundum ASD using the Occlutech® ACCELL® Flex II Device. The follow-up period ranged from 5.2–5.5 years with median of 5.3 years. Detailed history and full clinical examination, twelve-lead electrocardiogram (ECG), plain chest radiograph, and full 2D transthoracic echocardiography (TTE) were performed at discharge, at one month, six months, and yearly thereafter. Results. The mean age of the study group at the last follow-up was 10.4 ± 4.6 years, with 63.3% (nineteen patients) females. There were no residual shunts or complications encountered immediately after the procedure and at the latest follow-up. Conclusion. This study confirmed the transcatheter closure (TCC) of secundum ASDs using the Occlutech® ACCELL® Flex II device to be safe and effective with no complications detected in children and adolescents.

2015 ◽  
Vol 16 (4) ◽  
pp. 445-451 ◽  
Author(s):  
Maggie Bellew ◽  
Paul Chumas

OBJECT The aim of this study was to determine the distribution of Full Scale IQ (FSIQ) by type of craniosynostosis and to verify the finding that at long-term follow-up, verbal IQ (VIQ) is significantly higher than performance IQ (PIQ) in patients with single-suture sagittal synostosis (SS) despite falling within the “average” range for intelligence. Whether this also occurs in other types of craniosynostosis and whether surgery and sex are relevant were also determined. The relationship between age at time of surgery and later IQ was ascertained. METHODS The data for 91 children with craniosynostosis (47 sagittal, 15 unicoronal, 13 metopic, 9 multisuture, and 7 bicoronal) were collected at their routine, 10 years of age IQ assessment (mean age 123.8 months). The patients included 61 males and 30 females; 62 patients had undergone surgery and 29 had not. RESULTS The mean FSIQ for all types of craniosynostosis combined (96.2) fell within the average range for the general population. Some variation was evident across the different types of craniosynostosis: the SS group showed the highest FSIQs and a “normal” distribution of bandings; the other types had a higher proportion of FSIQs in the lower bandings. The data confirmed the finding that VIQ is greater than PIQ despite falling within the average range for intelligence, with a difference of 5.0 for all types of craniosynostosis combined (p = 0.001), 7.6 for the SS group (p = 0.001), and 6.9 for the unicoronal group (p = 0.029). This VIQ > PIQ effect was not found with multisuture craniosynostosis. The VIQ > PIQ discrepancy occurred regardless of whether the patient had undergone surgery and occurred more often in males than females. In the SS group and the bicoronal group, FSIQ (p = 0.036 and p = 0.046, respectively) and PIQ (p = 0.012 and p = 0.017, respectively), though not VIQ, were higher when surgery had been performed early. CONCLUSIONS The study confirms that at long-term follow-up, although children with nonsyndromic craniosynostosis fall within the normal range for intelligence, there is a VIQ > PIQ discrepancy above what would be expected in the normal population, which may be indicative of more subtle difficulties in achievement. This discrepancy is affected by type of craniosynostosis, sex, and age at time of surgery.


2020 ◽  
pp. 112067212097604
Author(s):  
Reem R Al Huthail ◽  
Yasser H Al-Faky

Objective: To evaluate the effect of chronicity on the size of the ostium after external dacryocystorhinostomy (DCR) with intubation. Methods: Design: A retrospective chart review of patients who underwent external DCR with intubation over 10 years from January 2003 at a tertiary hospital. All patients were recruited and examined with rigid nasal endoscope. Results: A total number of 66 (85 eyes) patients were included. The mean age at the time of evaluation was 53.1 years with gender distribution of 54 females (81.8 %). The mean duration ±SD between the date of surgery and the date of evaluation was 33.2 ± 33.6 (6–118 months). Our study showed an overall anatomical and functional success of 98.8% and 95.3%, respectively. The mean size of the ostium (±SD) was 23.0 (±15.7) mm2 (ranging from 1 to 80.4 mm2). The size of the ostium was not a significant factor for failure ( p = 0.907). No statistically significant correlation was found between the long-term duration after surgery and the size of the ostium ( R: 0.025, p = 0.157). Conclusions: Nasal endoscopy after DCR is valuable in evaluating the ostium with no observed potential correlation between the long-term follow-up after surgery and the size of the ostium.


2013 ◽  
Vol 118 (1) ◽  
pp. 58-62 ◽  
Author(s):  
William J. Kemp ◽  
Daniel H. Fulkerson ◽  
Troy D. Payner ◽  
Thomas J. Leipzig ◽  
Terry G. Horner ◽  
...  

Object A small percentage of patients will develop a completely new or de novo aneurysm after discovery of an initial aneurysm. The natural history of these lesions is unknown. The authors undertook this statistical evaluation a large cohort of patients with both ruptured and unruptured de novo aneurysms with the aim of analyzing risk factors for rupture and estimating a risk of subarachnoid hemorrhage (SAH). Methods A review of a prospectively maintained database of all aneurysm patients treated by the vascular neurosurgery service of Goodman Campbell Brain and Spine from 1976–2010 was performed. Of the 4718 patients, 611 (13%) had long-term follow-up imaging. The authors identified 27 patients (4.4%) with a total of 32 unruptured de novo aneurysms from routine surveillance imaging. They identified another 10 patients who presented with a new SAH from a de novo aneurysm after treatment of their original aneurysm. The total study group was thus 37 patients with a total of 42 de novo aneurysms. The authors then compared the 27 patients with incidentally discovered aneurysms with the 10 patients with SAH. A statistical analysis was performed, comparing the 2 groups with respect to patient and aneurysm characteristics and risk factors. Results Thirty-seven patients were identified as having true de novo aneurysms. This group had a female predominance and a high percentage of smokers. These 37 patients had a total of 42 de novo aneurysms. Ten of these 42 aneurysms hemorrhaged. De novo aneurysms in both the SAH and non-SAH group were anatomically small (< 10 mm). The estimated risk of hemorrhage over 5 years was 14.5%, higher than the expected SAH risk of small, unruptured aneurysms reported in the ISUIA (International Study of Unruptured Intracranial Aneurysms) trial. There was no statistically significant correlation between hemorrhage and any of the following risk factors: hypertension, diabetes, tobacco and alcohol use, polycystic kidney disease, or previous SAH. There was a statistically significant between-groups difference with respect to patient age, with the mean patient age being significantly older in the SAH aneurysm group than in the non-SAH group (p = 0.047). This is likely reflective of longer follow-up and discovery time, as the mean length of time between initial treatment and discovery of the de novo aneurysm was longer in the SAH group (p = 0.011). Conclusions While rare, de novo aneurysms may have a risk for SAH that is comparatively higher than the risk associated with similarly sized, small, initially discovered unruptured saccular aneurysms. The authors therefore recommend long-term follow-up for all patients with aneurysms, and they consider a more aggressive treatment strategy for de novo aneurysms than for incidentally discovered initial aneurysms.


2002 ◽  
Vol 12 (3) ◽  
pp. 224-228 ◽  
Author(s):  
Haifa Abdul Latiff ◽  
Mazeni Alwi ◽  
Hasri Samion ◽  
Geetha Kandhavel

This study reviewed the short-term outcome of transcatheter closure of the defects within the oval fossa using an Amplatzer® Septal Occluder. From January 1997 to December 2000, 210 patients with defects within the oval fossa underwent successful transcatheter closure. We reviewed a total of 190 patients with left-to-right shunts, assessing the patients for possible complications and the presence of residual shunts using transthoracic echocardiogram at 24 h, 1 month, 3 months and one year. Their median age was 10 years, with a range from 2 to 64 years, and their median weight was 23.9 kg, with a range from 8.9 to 79 kg. In 5 patients, a patent arterial duct was closed, and in 2 pulmonary balloon valvoplasty performed, at the same sitting. The median size of the Amplatzer® device used was 20 mm, with a range from 9 to 36 mm. The median times for the procedure and fluoroscopy were 95 min, with a range from 30 to 210 min, and 18.4 min, with a range from 5 to 144 min, respectively. Mean follow-up was 20.8 ± 12.4 months. Complete occlusion was obtained in 168 of 190 (88%) patients at 24 h, 128 of 133 (96.2%) at 3 months, and 103 of 104 (99%) at one year. Complications occurred in 4 (2.1%) patients. In one, the device became detached, in the second the device embolized into the right ventricular outflow tract, the lower end of the device straddled in the third, and the final patient had significant bleeding from the site of venupuncture. There were no major complications noted on follow-up. We conclude that transcatheter closure of defects within the oval fossa using the Amplatzer® Septal Occluder is safe and effective. Long-term follow-up is required, nonetheless, before it is recommended as a standard procedure.


2021 ◽  
Vol 10 (2) ◽  
pp. 189
Author(s):  
Joanna Konopińska ◽  
Łukasz Lisowski ◽  
Zofia Mariak ◽  
Iwona Obuchowska

This study evaluated the characteristics and clinical course of patients with iris cysts in the long-term follow-up (24–48 months). We retrospectively analyzed the medical records of 39 patients with iris cysts (27 women and 12 men). Age, visual acuity, intraocular pressure (IOP), slit-lamp evaluation, and ultrasound biomicroscopy images were assessed. The mean age at diagnosis was 40.6 ± 17.48 years. Thirty (76.9%) cysts were peripheral, five (12.8%) were located at the pupillary margin, two (5.1%) were midzonal, and two (5.1%) were multichamber cysts extending from the periphery to the pupillary margin. A total of 23 (59%) cysts were in the lower temporal quadrant, 11 (28.2%) were in the lower nasal quadrant, and 5 (12.8%) were in the upper nasal quadrant. Cyst size was positively correlated with patient age (rs = 0.38, p = 0.003) and negatively correlated with visual acuity (rs = −0.42, p = 0.014). Cyst growth was not observed. The only complication was an increase in IOP in three (7.7%) patients with multiple cysts. The anatomical location of the cysts cannot differentiate them from solid tumors. The vast majority of cysts are asymptomatic, do not increase in size, and do not require treatment during long-term follow-up.


2021 ◽  
Vol 103-B (12) ◽  
pp. 1815-1820
Author(s):  
Stefan Huhnstock ◽  
Ola Wiig ◽  
Else Merckoll ◽  
Svein Svenningsen ◽  
Terje Terjesen

Aims The aim of this study was to assess the prognostic value of the modified three-group Stulberg classification, which is based on the sphericity of the femoral head, in patients with Perthes’ disease. Methods A total of 88 patients were followed from the time of diagnosis until a mean follow-up of 21 years. Anteroposterior pelvic and frog-leg lateral radiographs were obtained at diagnosis and at follow-up of one, five, and 21 years. At the five- and 21-year follow-up, the femoral heads were classified using a modified three-group Stulberg classification (round, ovoid, or flat femoral head). Further radiological endpoints at long-term follow-up were osteoarthritis (OA) of the hip and the requirement for total hip arthroplasty (THA). Results There were 71 males (81%) and 17 females. A total of 13 patients had bilateral Perthes’ disease; thus 101 hips were analyzed. At five-year follow-up, 37 hips were round, 38 ovoid, and 26 flat. At that time, 66 hips (65%) were healed and 91 (90%) were skeletally immature. At long-term follow-up, when the mean age of the patients was 28 years (24 to 34), 20 hips had an unsatisfactory outcome (seven had OA and 13 had required THA). There was a strongly significant association between the modified Stulberg classification applied atfive-year follow-up and an unsatisfactory outcome at long-term follow-up (p < 0.001). Between the five- and 21-year follow-up, 67 hips (76%) stayed in their respective modified Stulberg group, indicating a strongly significant association between the Stulberg classifications at these follow-ups (p < 0.001). Conclusion The modified Stulberg classification is a strong predictor of long-term radiological outcome in patients with Perthes’ disease. It can be applied at the healing stage, which is usually reached five years after the diagnosis is made and before skeletal maturity. Cite this article: Bone Joint J 2021;103-B(12):1815–1820.


2018 ◽  
Vol 08 (01) ◽  
pp. 037-042
Author(s):  
William Aibinder ◽  
Ali Izadpanah ◽  
Bassem Elhassan

Background Management of scapholunate (SL) ligament disruption is a challenging problem. The reduction and association of the scaphoid and lunate (RASL) procedure has been described with varying results. This study assessed the outcomes of the RASL procedure. Purpose The objective of this study was to assess the outcomes of patients undergoing the RASL procedure at our institution in regard to pain relief, range of motion, radiographic and functional outcomes, complications, and reoperations. Materials and Methods Twelve patients with symptomatic chronic SL instability underwent the RASL procedure. The mean age was 35 years. The mean time from injury to surgery was 40 weeks. The mean follow-up was 89 months. Outcomes included visual analog score for pain, wrist range of motion, grip strength, and Mayo Wrist Scores. Preoperative and postoperative radiographs were reviewed. Results Pain scores improved in 10 wrists. Range of motion and grip strength worsened. The average Mayo Wrist Score was 63.3. The mean SL diastasis and angle improved, but seven wrists developed progressive degenerative changes, with two requiring a salvage procedure. Symptomatic progressive screw lucency occurred in eight wrists requiring screw removal. Conclusion The RASL procedure can improve SL widening but has a high rate of early failure and reoperation. Following reoperation, long-term follow-up demonstrates reasonable long-term durability in some cases. Level of Evidence This is a Level IV, therapeutic case study.


2021 ◽  
Vol 8 ◽  
Author(s):  
Belén Alfonso-Bartolozzi ◽  
Carlos Lisa ◽  
Luis Fernández-Vega-Cueto ◽  
David Madrid-Costa ◽  
José F. Alfonso

Purpose: To assess the outcomes of implanting a new polymethylmethacrylate (PMMA) ring (Neoring; AJL Ophthalmic) in pre-descemet deep anterior lamellar keratoplasty (PD-DALK) procedure for moderate-advanced keratoconus.Methods: This prospective study included 10 eyes of 10 patients with moderate-advanced keratoconus who underwent PD-DALK with Neoring implantation. Neoring was implanted in a pre-descemetic pocket. The post-operative examination included refraction, corrected distance visual acuity (CDVA), corneal tomography, and endothelial cell density (ECD). The root mean squares (RMSs) for coma-like aberrations and spherical aberration were evaluated for a pupil size of 4.5 mm. The junctional graft (Tg) and host (Th) thicknesses were measured. The post-operative follow-up was 24 months.Results: Post-operative CDVA was 0.82 ± 0.14 (decimal scale), 100% of the eyes achieved a CDVA of 0.7 (decimal scale). The refractive cylinder was −2.86 ± 1.65 2-years after surgery. No eyes had a post-operative refractive cylinder ≥5.00 D and in five eyes (50%), it was ≤2.50 D. At the last visit, the mean keratometry was 45.64 ± 1.96 D, the RMS for coma-like aberrations was 0.30 ± 0.15 μm and spherical aberration was 0.22 ± 0.09. The mean ECD remains without changes over the follow-up (P = 0.07). At the last visit, Tg and Th were 679.9 ± 39.0 and 634.8 ± 41.2 μm, respectively. The thickness of the complex (host-Neoring) was 740.6 ± 35.6 μm. In all cases, this thickness was thicker than Tg.Conclusion: The results of this study suggest that PD-DALK along Neoring implantation is a viable, effective, and safe option to optimize the post-operative results for moderate-severe keratoconus.


2021 ◽  
Vol 11 ◽  
Author(s):  
Young Dong Yu ◽  
Young Hwii Ko ◽  
Jong Wook Kim ◽  
Seung Il Jung ◽  
Seok Ho Kang ◽  
...  

AimThis study evaluated the prognosis and survival predictors for bladder urachal carcinoma (UC), based on large scale multicenter cohort with long term follow-up database.MethodsA total 203 patients with bladder UC treated at 19 hospitals were enrolled. Clinical parameters on carcinoma presentation, diagnosis, and therapeutic methods were reviewed for the primary cancer and for all subsequent recurrences. The stage of UC was stratified by Mayo and Sheldon pathological staging system. Oncological outcomes and the possible clinicopathological parameters associated with survival outcomes were investigated.ResultsThe mean age of the patients was 54.2 years. Among the total of 203 patients, stages I, II, III, and IV (Mayo stage) were 48 (23.8%), 108 (53.5%), 23 (11.4%), and 23 (11.4%), respectively. Gross hematuria and bladder irritation symptoms were the two most common initial symptoms. The mean follow-up period was 65 months, and 5-year overall survival rates (OS), cancer-specific survival rates (CSS), and recurrence-free survival rates (RFS) were 88.3, 83.1, and 63.9%, respectively. For the patients with Mayo stage ≥III, OS, CSS, and RFS were significantly decreased to 38.0, 35.2, and 28.4%, respectively. The higher pathological stage (Mayo stage ≥III, Sheldon stage ≥IIIc), positive surgical margin (PSM), and positive lymphovascular invasion (PLM) were independent predictors of shorter OS, CSS, and RFS.ConclusionThe pathological stage, PSM, and PLM were significantly associated with the survival of UC patients, emphasizing an importance of the complete surgical resection of tumor lesion.


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