40 CFR 63.964 - Inspection and monitoring requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

.... Defects include, but are not limited to, visible cracks, holes, or gaps in the closure devices; broken..., visible cracks, holes, or gaps in the closure devices; broken, cracked, or otherwise damaged seals or..., visible cracks, holes, gaps, or other open spaces in the sewer line joints, seals, or other emission...

40 CFR 63.964 - Inspection and monitoring requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... Defects include, but are not limited to, visible cracks, holes, or gaps in the closure devices; broken..., visible cracks, holes, or gaps in the closure devices; broken, cracked, or otherwise damaged seals or..., visible cracks, holes, gaps, or other open spaces in the sewer line joints, seals, or other emission...

Transcatheter closure of Patent Ductus Arteriosus through only venous route.

PubMed

Sheikh, Abdul Malik; Duke, Abdul Karim; Sattar, Hina

2018-03-01

Patent ductus arteriosus is a common congenital cardiac defect comprising 5-10% of all these defects in term neonates. Although open chest and video-assisted interruption are still in use, transcatheter occlusion has rapidly become the first choice for patent ductus arteriosus closure in the appropriate patient. Percutaneous closure of patent ductus arteriosus is widely done by transvenous approach guided by aortic access. We present the case of a 2 year old girl who underwent patent ductus arteriosus device occlusion with transvenous access only.

Intraoperative three-dimensional transesophageal echocardiography for assessing the defect geometries of mitral prosthetic paravalvular leak during transcatheter closure.

PubMed

Wei, Jeng; Yin, Wei-Hsian; Lee, Yung-Tsai; Hsiung, Ming C; Tsai, Shen-Kou; Chuang, Yi Cheng; Ou, Ching-Huei; Chou, Yi-Pen

2015-03-01

Paravalvular leaks (PVLs) are a common complication of prosthetic valve replacement. Use of the transcatheter intervention technique is a suitable alternative in high-risk patients who may not tolerate repeat surgery. Common reasons for failure of this demanding intervention include poor imaging quality and unsuitable anatomy. The purpose of this study was to assess the usefulness and the incremental value of real-time three-dimensional (RT 3D) transesophageal echocardiography (TEE) over two-dimensional (2D) TEE findings in the evaluation of the geometry and track of mitral PVLs during transcatheter closure. Five patients with six mitral PVLs at high risk for repeat surgery underwent transcatheter leak closure. Intraoperative RT 3DTEE was used to assess the location, shape, number, and size of the defects. Transapical approaches were used in all cases with fluoroscopic and RT 3D TEE guidance of the wire and catheter, device positioning, and assessment of residual leak after the procedure. In all of the cases, defects with irregular crescent shapes and distorted tracks were clearly delineated by RT 3D TEE. This was compared to those results obtained through 2D TEE, which was unable to characterize the defects. Three cases showed small leaks, which were completely occluded with a patent ductus arteriosus (PDA) device in two cases, and a muscular ventricular septal defect (mVSD) occluder combined with coil devices in one case. One case involved a large leak and early device embolization of the muscular VSD occluder, which was removed surgically, and demonstrated a crescent-shaped defect. One patient had two releaks 2 months subsequent to the procedure due to two new extended leaks at the tails of the crescent-shaped defect. RT 3D TEE can clearly delineate the geometries of defects in their entirety, including shape, size, and location of the defect and track canal. It would also appear that RT 3D TEE is superior to 2D TEE in the process of guiding the wire through the difficult canal anatomy, facilitating the overall procedure. The small mitral PVLs can be completely occluded, but subsequent complications occurred with large defect closures because of embolization or releak. Therefore, transcatheter closure of PVLs seems to be an attractive alternative for these patients, but newer occluder designs that better conform to leak geometry will be required to improve outcomes. Copyright © 2014. Published by Elsevier Taiwan.

Current topics in surgery for multiple ventricular septal defects.

PubMed

Yoshimura, Naoki; Fukahara, Kazuaki; Yamashita, Akio; Doki, Yoshinori; Takeuchi, Katsunori; Higuma, Tomonori; Senda, Kazutaka; Toge, Masayoshi; Matsuo, Tatsuro; Nagura, Saori; Aoki, Masaya; Sakata, Kimimasa; Sakai, Mari

2016-04-01

In this review article, we describe several topics, including the sandwich technique, the transatrial re-endocardialization technique, the limited apical left ventriculotomy approach and device closure. The sandwich technique was introduced for the closure of muscular ventricular septal defects (VSD) by sandwiching the septum between two felt patches placed in the left and right ventricle. This technique requires neither the transection of muscular trabeculae nor ventriculotomy. Although the sandwich technique has resulted in the improvement of surgical outcomes, cases of postoperative cardiac dysfunction have been reported. Multiple smaller VSDs have been closed with transatrial re-endocardialization. Septal dysfunction may be avoided through this technique, in which the septal trabeculae are approximated in two layers of superficial, endocardial running sutures. Recently, a number of reports have recommended a limited apical left ventriculotomy approach. With this technique, a much shorter incision of around 1 cm at the apex of the left ventricle may be sufficient for achieving the complete closure of apical muscular VSDs. The transcatheter or perventricular device closure of muscular VSDs has increasingly been performed with good results. Although favorable early and mid-term results of device closure have been reported, this method is not always safer or less invasive than surgical closure. Long-term evaluations should be performed to determine whether the right and left ventricular functions are affected by treatment with relatively large devices in the heart.

[Right patent ductus arteriosus with an ipsilateral aortic arch: percutaneous closure with amplatzer devices].

PubMed

Santiago, Justo; Acuña, Manuel; Arispe, Elizabeth; Camargo, Ronaldo; Neves, Juliana; Arnoni, Daniel; Fontes, Valmir F; Pedra, Carlos A

2007-03-01

The association of a right aortic arch with an ipsilateral patent ductus arteriosus is rare, especially when there are no other intracardiac anomalies. We report three female patients aged 26, 35 and 9 years with this combination in whom previous attempts at surgical closure by thoracotomy and sternotomy were unsuccessful and who subsequently underwent successful percutaneous closure of the defects using Amplatzer devices. In two patients, although angiography demonstrated the presence of type-A patent ductus arteriosus, it was not possible to determine the minimum diameter accurately and it was necessary to measure it using a sizing balloon. An Amplatzer duct occluder was used in two patients and an Amplatzer muscular ventricular septal defect occluder, in the other. In all patients, full closure was confirmed in the catheterization laboratory and the patients were discharged on the same day with no complications. Percutaneous closure of a right patent ductus arteriosus associated with a right aortic arch is feasible, safe and effective.

Arrhythmias after transcatheter closure of perimembranous ventricular septal defects with a modified double-disk occluder: early and long-term results.

PubMed

Li, Pan; Zhao, Xian-xian; Zheng, Xing; Qin, Yong-wen

2012-07-01

With the development of interventional techniques and devices, transcatheter closure of perimembranous ventricular septal defect has been widely performed. However, there has been a lack of long-term follow-up results about postoperative ECG changes of PmVSD patients. We report our experience of early and late arrhythmias after transcatheter closure of PmVSD with a modified double-disk occluder (MDVO). We performed a retrospective review of 79 patients (47 males, 32 females) between September 2002 and May 2007 who underwent transcatheter closure of perimembranous ventricular septal defect. Symmetric and asymmetric PmVSD occluders were used. The diameter of the evaluated defects ranged from 3 to 12 mm, as measured by TTE and 3 to 15 mm by left ventriculography. Most cases of PmVSD were treated successfully with a single procedure, resulting in a successful closure rate of 97% (77/79 patients). There was no death in any of the patients. After the operation, 79 patients were followed-up for a range of 10-76 months (35.3 ± 17.4 months). In this series, 11 cases of incomplete right bundle branch block and five cases of complete right bundle branch block occurred during the early period after operation. During long-term follow-up, these issues declined in prevalence to five and four cases, respectively. Moreover, reversible third-degree AVB occurred during closure or after the procedure, and two of the three patients with reversible AVB received a temporary heart pacemaker implantation. These patients recovered 1 h, 6 days, and 9 days later, respectively. During 10-76 months of follow-up, no complications occurred in any of the patients, including residual shunt, severe aortic valve, or tricuspid valve regurgitation. Device closure of perimembranous ventricular septal defects with a modified double-disk occluder (MDVO) resulted in excellent closure rates and acceptably low arrhythmia rates.

Self-expanding platinum-coated nitinol devices for transcatheter closure of atrial septal defect: prevention of nickel release.

PubMed

Lertsapcharoen, Pornthep; Khongphatthanayothin, Apichai; Srimahachota, Suphot; Leelanukrom, Ruenreong

2008-06-01

A variety of nitinol-containing devices for transcatheter closure of atrial septal defects (ASD) has been widely used. However, there is concern about the release of nickel after nitinol device implantation. In this study, a platinum-coated nitinol device was braided from nanoplatinum-coated nitinol wires in order to prevent nickel release. The serum nickel levels before and after device implantation and the 1-year results were evaluated. Thirty-one patients, aged 4-59 years, and weighing 13.7-90.0 kg, underwent transcatheter closure. Blood samples for serum nickel levels were taken before, 1 day, 1 week, 1 month and 3 months after implantation. Twenty-nine (93.6%) patients had a successful implantation. The mean ASD diameter was 19.7 +/- 4.8 mm (range 10-30 mm). Procedure-related complications included transient brachial plexus injury in 1 patient and transient dysrhythmia in 4 patients. All 29 patients had complete closure within 1 month after implantation. The mean serum nickel levels at baseline and at 1 day, 1 week, 1 month and 3 months after implantation were 0.65 +/- 0.28, 0.63 +/- 0.18, 0.67 +/- 0.34, 0.55 +/- 0.16, 0.52 +/- 0.14 ng/ml, respectively. There was no significant difference in serum nickel levels before and after implantation. There were no device-related complications at 1-year follow up. Transcatheter ASD closure using a platinum-coated nitinol device can be performed safely and successfully with good outcomes. Nano-coating of platinum on nitinol wires can prevent nickel release following device implantation.

Percutaneous device closure of atrial septal defect results in very early and sustained changes of right and left heart function.

PubMed

Monfredi, Oliver; Luckie, Matthew; Mirjafari, Hoda; Willard, Terence; Buckley, Helen; Griffiths, Linda; Clarke, Bernard; Mahadevan, Vaikom S

2013-08-20

To investigate the echocardiographic effects of percutaneous closure of secundum atrial septal defect (ASD) in adults and assess which pre-closure parameters predict good response to closure. ASD is a common congenital heart disease often undiscovered until adulthood. ASD closure has been revolutionized by the use of percutaneous devices. The effects of these procedures on echocardiographic parameters are not well characterized. Patients undergoing percutaneous device closure of ASD between June 2007 and June 2009 had 3 sequential echocardiograms reviewed: pre-procedure, immediate post-procedure (24 hours) and 6-8 weeks post-procedure. Significant changes from baseline were investigated using paired t-test/1-way ANOVA. Pearson correlation (2-tailed) tests were used to categorize patients as 'good responders' to closure in terms of selected parameters. 129 echocardiograms in 43 consecutive patients were included. Remodeling of both ventricles occurred immediately following ASD closure and was sustained. Right ventricular (RV) diameter in diastole decreased by 13.5% and 19.3% compared to baseline at 24 hours and 6-8 weeks post-closure, respectively (p<0.05); Left ventricular (LV) diameter in diastole increased by 8.5% and 15.6%, respectively (p<0.05). Functional parameters of the RV also demonstrated early and sustained decreases (TAPSE decreased by 8.3% and 17% compared to baseline at 24 hours and 6-8 weeks post-closure, respectively (p<0.05)). Smaller RV baseline diameter appeared to predict good response to closure. Percutaneous ASD closure has immediate, sustained benefits on multiple echocardiographic parameters. Good responders have smaller RV at baseline, suggesting early closure is preferable. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Primary limited lumbar discectomy with an annulus closure device: one-year clinical and radiographic results from a prospective, multi-center study.

PubMed

Lequin, Michiel B; Barth, Martin; Thomė, Claudius; Bouma, Gerrit J

2012-12-01

Discectomy as a treatment for herniated lumbar discs results in outcomes after surgery that are not uniformly positive. Surgeons face the dilemma between limited nucleus removal which is associated with a higher risk of recurrence, or more aggressive nucleus removal which may lead to disc height loss and persistent back-pain. annulus closure devices may allow for the benefits of limited nucleus removal without the increased risk of recurrence. This is an interim report of an ongoing 24-month post-marketing study of the Barricaid® annulus closure device, consisting of a flexible polymer mesh that blocks the defect, held in place by a titanium bone anchor. We prospectively enrolled 45 patients at four hospitals, and implanted the Barricaid® after a limited discectomy. annulus defect size and volume of removed nucleus were recorded. Reherniations were reported, pain and function were monitored and imaging was performed at regular intervals during 24 months of follow-up. At 12 months postsurgery, pain and function were significantly improved, comparing favorably to reported results from limited discectomy. Disc height has been well maintained. One reherniation has occurred (2.4%), which was associated with a misplaced device. No device fracture, subsidence or migration has been observed. The use of an annulus closure device may provide a reduction in reherniation rate for lumbar discectomy patients with large annulus defects who are at the greatest risk of recurrence. Using such a device should provide the surgeon increased confidence in minimizing nucleus removal, which, in turn, may preserve disc height and biomechanics, reducing degeneration and associated poor clinical outcomes in the long-term. A randomized multicenter study evaluating limited discectomy with and without the Barricaid® is currently underway, and will provide a higher level of evidence.

Surgical repair of tricuspid valve leaflet tear following percutaneous closure of perimembranous ventricular septal defect using Amplatzer duct occluder I: Report of two cases

PubMed Central

Kuwelker, Saatchi Mahesh; Shetty, Devi Prasad; Dalvi, Bharat

2017-01-01

Tricuspid valve (TV) injury following transcatheter closure of perimembranous ventricular septal defect (PMVSD) with Amplatzer ductal occluder I (ADO I), requiring surgical repair, is rare. We report two cases of TV tear involving the anterior and septal leaflets following PMVSD closure using ADO I. In both the patients, the subvalvular apparatus remained unaffected. The patients presented with severe tricuspid regurgitation (TR) 6 weeks and 3 months following the device closure. They underwent surgical repair with patch augmentation of the TV leaflets. Postoperatively, both are asymptomatic with a mild residual TR. PMID:28163430

Fenestrated Transcatheter ASD Closure in Adults with Diastolic Dysfunction and/or Pulmonary Hypertension: Case Series and Review of the Literature.

PubMed

Abdelkarim, Ayman; Levi, Daniel S; Tran, Bao; Ghobrial, Joanna; Aboulhosn, Jamil

2016-12-01

This study aims to evaluate the safety and efficacy of transcatheter fenestrated ASD closure and to summarize the literature regarding the published techniques and outcomes of transcatheter partial ASD closure. Patients with left ventricular diastolic dysfunction (LVDD) or right ventricular (RV) dysfunction and/or pulmonary hypertension (PHT) may suffer untoward consequences of complete closure of an ostium secundum atrial septal defect (ASD). Therefore, for patients that fall under these categories we suggest partial occlusion of the defect, which may be better tolerated than complete defect closure. After obtaining IRB approval, a search for patients that have undergone percutaneous ASD closure was performed in the Ahmanson/UCLA Adult Congenital Heart Disease Center database to identify which patients received a fenestrated ASD closure device. Eight consecutive patients ranging between 22 and 83 years of age (mean 48 years) with PHT and/or LVDD or RV dysfunction who underwent fenestrated transcatheter ASD closure at UCLA were identified. None of the subjects experienced complications related to the procedure. Postprocedure clinical evaluation showed improvement in symptoms and exercise capacity. Available follow-up transthoracic echocardiography data (mean 4 months, range 0-20 months) demonstrated patent fenestrations in four of eight patients. None of the patients had thromboembolic or infectious complications and there were no device migrations, erosions or embolizations. Partial ASD occlusion in patients with diastolic dysfunction or RV dysfunction and/or PHT is safe and may be better tolerated than complete ASD closure in selected patients. © 2016 Wiley Periodicals, Inc.

Catheter closure of secundum atrial septal defects.

PubMed

O'Laughlin, M P

1997-01-01

Catheter occlusion of atrial septal defects has its roots in the 1950s, with early devices being implanted during closed-heart surgery without cardiopulmonary bypass. For the past 20 years, various catheter-delivered devices have undergone testing and refinement. Designs have included single- and double-disk prostheses, with a variety of materials, delivery systems, and techniques. In this monograph, the history of atrial septal defect occluders and their evaluation, results, and prognoses will be outlined. The early work of King and Mills has been advanced in the forms of the Rashkind and Lock-USCI Clamshell occluders (USCI; Billerica, Mass), the "buttoned" device (custom made by E.B. Sideris), the Babic atrial septal defect occlusion system (Osypka, GmbH; Grenzach-Wyhlen, Germany), the Das-Angel Wings atrial septal defect occlusion device (Microvena Corporation; White Bear Lake, Minn), and others. The future holds promise for approved devices in the treatment of selected secundum atrial septal defects.

Intracardiac echocardiography to guide closure of atrial septal defects in children less than 15 kilograms.

PubMed

Patel, Angira; Cao, Qi-Ling; Koenig, Peter R; Hijazi, Ziyad M

2006-08-01

Intracardiac echocardiography (ICE) is increasingly replacing transesophageal echocardiography (TEE) as the primary imaging technique to guide device closure of atrial septal defects (ASD). Owing to the length of the procedure, the use of TEE requires general anesthesia. Investigators have reported the usefulness of ICE in adults and children. However, little is known about the use of ICE in children whose weight is <15 kg. Therefore, this study examines the use of ICE guided secundum ASD closure in children <15 kg. Nineteen patients with a median age of 3.1 years (range 1.8-4.8), and median weight of 13.2 kg (range 8.0-14.4) underwent transcatheter occlusion (Amplatzer occluder) of a secundum ASD using ICE guidance. ICE was performed using an Acunav catheter. The ICE catheter (10 F shaft) was introduced into an 11 F sheath in a contralateral femoral vein. Diagnostic as well as periprocedure imaging was obtained. Sixteen patients had single, and three had multiple defects. Median defect size as measured by ICE was 16 mm (range 2.5-25). The median balloon stretched diameter (obtained in eight patients) was 18 mm (range 10-21); the median size of the defect for these eight patients was 15 mm (range of 8-20). Both techniques for measuring the defect correlated well with r = 0.94. The ASD occluder size ranged from 7 to 26 mm with a median of 18 mm. The procedure was successful in 16 patients who had a device implanted and no residual shunt. ASD occlusion was not attempted in two patients due to deficient rims and in one patient, the attempt failed due to left atrial disk prolapse through the ASD. Four patients experienced transient complications during the catheter procedure, including supra ventricular tachycardia, sinus bradycardia, and two with complete heart block (resolving with device removal); all had subsequent successful device placement. No complications were attributed to the use of ICE and specifically, no vascular injury was noted. Comparable to results with larger patients, ICE provides adequate imaging (preprocedure diagnosis and periprocedure guidance) during device occlusion of secundum ASDs with no significant complications. Thus, ICE can successfully be used in the closure of ASD in smaller patients (<15 kg) and eliminate the need for endotracheal intubation.

The off-label use of the Amplatzer muscular VSD occluder for large patent ductus arteriosus: a case report and review.

PubMed

Cubeddu, Roberto J; Babin, Ivan; Inglessis, Ignacio

2014-07-01

A percutaneous approach to the closure of patent ductus arteriosus (PDA) is the preferred procedure in the majority of cases. However, there is little experience with percutaneous closure of unusually large PDA. We report the case of a 28-year-old female with moderate left ventricular dilation and pulmonary hypertension resulting from a large 16 mm PDA. Percutaneous closure was successfully performed using an off-label Amplatzer muscular ventricular septal defect occluder after intravascular ultrasound assessment. Technical challenges, including accurate assessment of defect size and device selection are exemplified along with a comprehensive overview of the available literature.

ASD Closure in Structural Heart Disease.

PubMed

Wiktor, Dominik M; Carroll, John D

2018-04-17

While the safety and efficacy of percutaneous ASD closure has been established, new data have recently emerged regarding the negative impact of residual iatrogenic ASD (iASD) following left heart structural interventions. Additionally, new devices with potential advantages have recently been studied. We will review here the potential indications for closure of iASD along with new generation closure devices and potential late complications requiring long-term follow-up. With the expansion of left-heart structural interventions and large-bore transseptal access, there has been growing experience gained with management of residual iASD. Some recently published reports have implicated residual iASD after these procedures as a potential source of diminished clinical outcomes and mortality. Additionally, recent trials investigating new generation closure devices as well as expanding knowledge regarding late complications of percutaneous ASD closure have been published. While percutaneous ASD closure is no longer a novel approach to managing septal defects, there are several contemporary issues related to residual iASD following large-bore transseptal access and new generation devices which serve as an impetus for this review. Ongoing attention to potential late complications and decreasing their incidence with ongoing study is clearly needed.

[Closure of wide patent ductus arteriosus using a fenestrated muscular VSD occluder device in a pediatric patient with Down syndrome and pulmonary hypertension].

PubMed

Güvenç, Osman; Saygı, Murat; Demir, İbrahim Halil; Ödemiş, Ender

2017-06-01

Patients with wide patent ductus arteriosus and significant pulmonary hypertension not treated in time constitute a significant problem for cardiologists. For these patients, tests that could aid in decision-making for further planning include reversibility and balloon occlusion tests performed in the catheterization laboratory. Devices developed for the closure of ductus as well as different devices with off-label use may be employed in patients scheduled for transcatheter occlusion. When result of reversibility test is borderline positive, the use of fenestrated device may be applicable for selected patients. Presently described is case of a 10-year-old patient with Down syndrome who had a wide ductus and systemic pulmonary hypertension. Transcatheter closure procedure was performed with off-label use of a fenestrated muscular ventricular septal defect occluder device.

A novel one-shot circular stapler closure for atrial septal defect in a beating-heart porcine model.

PubMed

Tarui, Tatsuya; Tomita, Shigeyuki; Ishikawa, Norihiko; Ohtake, Hiroshi; Watanabe, Go

2015-02-01

In surgical atrial septal defect (ASD) closure, there are no techniques or devices that can close the ASD accurately in a short time under a beating heart. We have developed a simple and automatic ASD closure technique using a circular stapler. This study assessed the feasibility and efficacy of a new circular stapler closure for ASD. Under a continuous beating heart, hand-sewn patch plasty ASD closure was performed in 6 pigs (group A) and circular stapler ASD closure was performed in 6 pigs (group B). The time to close the ASD and the effectiveness of the closure were compared. Closure was significantly faster in group B (10.5 ± 1.0 seconds) than in group A (664 ± 10 seconds; p < 0.05). There was no leakage at the closure site, and sufficient tolerance was confirmed. A circular stapler can be used to treat ASD faster than hand-sewn patch plasty, with sufficient pressure tolerance in a beating heart porcine model. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Right Ventricle before and after Atrial Septal Defect Device Closure.

PubMed

Akula, Vidya Sagar; Durgaprasad, Rajasekhar; Velam, Vanajakshamma; Kasala, Latheef; Rodda, Madhavi; Erathi, Harsha Vardhan

2016-09-01

Percutaneous atrial septal defect (ASD) device closure is a safe and effective means of reducing or eliminating interatrial shunting. The response of the right heart to device closure is incompletely understood. To evaluate the effects of transcatheter closure of secundum ASD on right ventricle size and function, that is, both systolic and diastolic by transthoracic echocardiography (TTE) over a 6-month period. Seventy-three patients had 73 device implantations. The patients were assessed with echocardiography before and at 1 and 6 months after procedure. Mean age was 26 ± 17 years. Mean ASD size indexed to body surface area (BSA) was 19.1 ± 8.6 mm/m(2) . The device size ranged from 12 to 42 mm. One month after closure, there were statistically significant decreases in right ventricular (RV) basal diameter (3.5 ± 0.7 cm vs. 4.2 ± 0.8 cm), RV/LV end-diastolic diameter ratio (0.9 ± 0.1 vs. 1.2 ± 0.2), left ventricular eccentricity index (LVEI) (1.0 ± 0.1 vs. 1.2 ± 0.2), right atrial (RA) major dimension (4.4 ± 0.8 cm vs. 4.8 ± 1.0 cm), RA end-systolic area (13.2 ± 4.6 cm(2) vs. 18.5 ± 6.7 cm(2) ), tricuspid annular plane systolic excursion (TAPSE) (2.2 ± 1.8 cm vs. 2.8 ± 0.5 cm), tricuspid annular systolic velocity (TASV or S') (13.1 ± 3.0 cm/sec vs. 16.0 ± 2.8 cm/sec), E/A (1.4 ± 0.3 vs. 1.7 ± 0.5), and E/e' (5.9 ± 5.0 vs. 7.2 ± 2.0) in comparison with baseline. Six months after closure, there were statistically significant decreases in RV major dimension (5.9 ± 1.1 cm vs. 6.3 ± 1.0 cm), RV/LV end-diastolic diameter ratio (0.8 ± 0.1 vs. 0.9 ± 0.1), RA major dimension (4.1 ± 0.8 cm vs. 4.4 ± 0.8 cm), and RA end-systolic area (11.4 ± 3.8 cm(2) vs. 13.2 ± 4.6 cm(2) ) in comparison with 1 month post-device closure. After 6 months, there was a statistically insignificant increase in both TASV (13.7 ± 2.8 cm/sec vs. 13.1 ± 3.0 cm/sec) and TAPSE (2.5 ± 1.6 cm/sec vs. 2.2 ± 1.8 cm/sec). There was no significant change in tissue Doppler MPI at baseline, 1 month, and 6 months after closure (0.38 ± 0.19 vs. 0.35 ± 0.15 vs. 0.38 ± 0.13). There was significant decrease in E/e' from baseline to 1 month and 1 month to 6 months after closure (7.2 ± 2.0 vs. 5.9 ± 5.0 vs. 4.7 ± 1.5). RV volumes decreased significantly in the first month after ASD device closure and continued up to 6 months. There was no change in global right ventricular systolic function but a high basal RV systolic function decreased after closure. Some patients had impaired diastolic function before closure of defect, which reversed to normal within 6 months after closure. Diastolic dysfunction in older age-group may be a cause for long duration taken by right heart chambers to regress and deserves further investigation. © 2016, Wiley Periodicals, Inc.

[Feasibility of device closure for multiple atrial septal defects using 3D printing and ultrasound-guided intervention technique].

PubMed

Qiu, X; Lü, B; Xu, N; Yan, C W; Ouyang, W B; Liu, Y; Zhang, F W; Yue, Z Q; Pang, K J; Pan, X B

2017-04-25

Objective: To investigate the feasibility of trans-catheter closure of multiple atrial septal defects (ASD) monitored by trans-thoracic echocardiography (TTE) under the guidance of 3D printing heart model. Methods: Between April and August 2016, a total of 21 patients (8 male and 13 female) with multiple ASD in Fuwai Hospital of Chinese Academy of Medical Sciences underwent CT scan and 3-dimensional echocardiography for heart disease model produced by 3D printing technique. The best occlusion program was determined through the simulation test on the model. Percutaneous device closure of multiple ASD was performed follow the predetermined program guided by TTE. Clinical follow-up including electrocardiogram and TTE was arranged at 1 month after the procedure. Results: The trans-catheter procedure was successful in all 21 patients using a single atrial septal occluder. Mild residual shunt was found in 5 patient in the immediate postoperative period, 3 of them were disappeared during postoperative follow-up. There was no death, vascular damage, arrhythmia, device migration, thromboembolism, valvular dysfunction during the follow-up period. Conclusion: The use of 3D printing heart model provides a useful reference for transcatheter device closure of multiple ASD achieving through ultrasound-guided intervention technique, which appears to be safe and feasible with good outcomes of short-term follow-up.

Percutaneous closure of secundum type atrial septal defects: More than 5-year follow-up

PubMed Central

Snijder, Roel JR; Suttorp, Maarten J; Berg, Jurriën M Ten; Post, Martijn C

2015-01-01

AIM: To investigate long-term efficacy of two different devices more than five years after percutaneous atrial septal defect (ASD) closure in adults. METHODS: All patients who underwent percutaneous closure of an ASD in the St. Antonius Hospital, Nieuwegein, The Netherlands, between February 1998 and December 2006 were included. Percutaneous closure took place under general anaesthesia and transesophageal echocardiographic monitoring. Transthoracic echocardiography (TTE) was performed 24 h post-procedure to visualize the device position and to look for residual shunting using color Doppler. All complications were registered. All patients were invited for an outpatient visit and contrast TTE more than 5-years after closure. Efficacy was based on the presence of a residual right-to-left shunt (RLS), graded as minimal, moderate or severe. The presence of a residual left-to-right shunt (LRS) was diagnosed using color Doppler, and was not graded. Descriptive statistics were used for patients’ characteristics. Univariate analysis was used to identify predictors for residual shunting. RESULTS: In total, 104 patients (mean age 45.5 ± 17.1 years) underwent percutaneous ASD closure using an Amplatzer device (ASO) in 76 patients and a Cardioseal/Starflex device (CS/SF) in 28 patients. The mean follow-up was 6.4 ± 3.4 years. Device migration occurred in 4 patients of whom two cases occurred during the index hospitalization (1 ASO, 1 CS/SF). The other 2 cases of device migration occurred during the first 6 mo of follow-up (2 CS/SF). The recurrent thrombo-embolic event rate was similar in both groups: 0.4% per follow-up year. More than 12 mo post-ASD closure and latest follow-up, new-onset supraventricular tachyarrhythmia’s occurred in 3.9% and 0% for the ASO and CS/SF group, respectively. The RLS rate at latest follow-up was 17.4% (minimal 10.9%, moderate 2.2%, severe 4.3%) and 45.5% (minimal 27.3%, moderate 18.2%, severe 0%) for the ASO- and CS/SF groups, respectively. There was no residual LRS in both groups. CONCLUSION: Percutaneous ASD closure has good long-term safety and efficacy profiles. The residual RLS rate seems to be high more than 5 years after closure, especially in the CS/SF. Residual LRS was not observed. PMID:25810815

Intra-operative device closure of perimembranous ventricular septal defect without cardiopulmonary bypass under guidance of trans-epicardial echocardiography: a single center experience.

PubMed

Sun, Yong; Zhu, Peng; Zhou, Pengyu; Guo, Yilong; Zheng, Shao-Yi

2016-05-27

Intraoperative device closure of perimembranous ventricular septal defect(VSD) through a lower mini-sternotomy is safe, less invasive, and has excellent surgical and cosmetic outcomes. Our study is to evaluate the feasibility of closing VSD under guidance of trans-epicardial echocardiography. We reviewed the clinical course of 41 patients referred to our institution for minimally invasive closure of perimembranous VSD. The trans-epicardial echocardiography(TEE) was used to monitor the whole procedure to guide the positioning of device and evaluate the operative effect instantly after operation. The procedure was successfully done in 38 patients(92.6 %) with mean age of 1.2 ± 1.5 years(range 0.5-6.1 years),mean weight of 10.78 ± 6.87 kg(range 5.2 ~ 26 kg) and VSD size of 5.1 ± 1.13 mm(range 5 ~ 10 mm). Three cases failed, including two cases whose guide-wires could not pass through VSDs and one case whose occluder could not repair VSD well. Three patients had tiny residual shunts because of the shifting of occluders. There were no major complications such as arrhythmia, valve regurgitation and the failure of occluder during follow-up(Mean 2.3 ± 1.2 years). TEE provided superior imaging of shapes and surrounding structures of the VSDs, and guide-wires passing through VSDs. Intraoperative device closure of perimembranous VSD through a lower mini-sternotomy without cardiopulmonary bypass appears to be a safe and effective procedure. The use of trans-epicardial echocardiography provides useful information for intraoperative device closure of VSD.

Morphologic Characteristics and Relating Factors to the Need of Technical Modification in Transcatheter Closure of Large Atrial Septal Defect (≥25 mm)

PubMed Central

Park, Su-Jin; Kim, Nam Kyun; Kim, Jung Ok; Yoo, Byung Won; Sul, Jun Hee

2010-01-01

Background and Objectives The rigid coupling between the delivery wire and the right atrial disk has been occasionally encountered during transcatheter closure of atrial septal defect (ASD). Therefore the device frequently makes a perpendicular angle, and the leading edge of left atrial disk slips through the defect and prolapses into right atrium (RA) before it is properly placed in the septum. The purpose of this study is to investigate relating factors to the need of technical modification in transcatheter closure of large ASD and to evaluate relevant morphologic characteristics of atrial septal rim in this situation. Subjects and Methods From July, 2003 to May, 2007, 312 patients underwent transcatheter occlusion of ASD with Amplatzer Septal Occluder® (ASO, AGA medical corporation, Golden Valley, MN, USA) at Yonsei Cardiovascular Center and among them 109 patients had large ASD (≥25 mm) and these patients were enrolled in our study. Patients were divided into two groups according to the deploying methods of the device (Group I: standard method, Group II: modified methods). Assessments of the defects and its surrounding rims were made by echocardiography. Results There were no differences between 2 groups in age, body weight and height except for balloon-stretched diameter (stop-flow technique) and device size. Group II patients with modified methods showed larger balloon-stretched diameter and device size than group I patients with standard method. The mean length of anterosuperior (AS) rim in group II was significantly shorter than group I (p<0.05). As the size of the device used in procedure increased, there was a trend towards increase in the need of modified methods. Conclusion This study shows that AS rim deficiency and the size of ASD may be the relating factors to the need of technical modification in transcatheter closure of ASD. Therefore, when the initial try with standard method is not successful in large ASD with deficient AS rim, we suggest that changing strategy of implantation may save time and efforts and possibly reduce the risk of complications associated with prolonged procedure. PMID:20421960

EASApprox® skin-stretching system: A secure and effective method to achieve wound closure.

PubMed

Song, Mingzhi; Zhang, Zhen; Liu, Tao; Liu, Song; Li, Gang; Liu, Zhaochang; Huang, Jingyang; Chen, Song; Li, Linan; Guo, Li; Qiu, Yang; Wan, Jiajia; Liu, Yuejian; Wu, Tao; Wang, Xiaoyong; Lu, Ming; Wang, Shouyu

2017-07-01

Large skin defects are commonly observed in the clinic and have attracted much attention recently. Therefore, finding an effective solution for large skin defects is a global problem. The objective of the present study was to assess the effectiveness of the EASApprox ® skin-stretching system for closing large skin defects. Skin defects (5×5 cm) were created on the forearms of 9 Bama miniature pigs, which were randomly divided into the following three groups: Direct suture, the new EASApprox ® skin-stretching device and Kirschner wires. Microcirculation was assessed before surgery and after wound closure. Following the different treatments, the defects were sutured, and wound healing was assessed based on a clinical score. Furthermore, microscopic and ultramicroscopic structures were evaluated, including collagen, elastic fibers and the microvessel density. Significant differences in the clinical score and microvessel density were observed among the groups. Additionally, the mean length obtained for elastic fibers was larger than that obtained for the other two groups. Finally, the new EASApprox ® skin-stretching device resulted in successful wound management and with only minor side effects on skin histology and microcirculation. Therefore, this method has the potential to be used for healing large skin defects.

Fenestrated atrial septal defect percutaneously occluded by a single device: procedural and financial considerations.

PubMed

Tal, Roie; Dahud, Qarawani; Lorber, Avraham

2013-06-01

A 45-year-old patient presented with a cerebrovascular attack and was subsequently found to have a multi-fenestrated atrial septal defect. Various therapeutic options for percutaneous transcatheter closure with their respective benefits and flaws are discussed, as well as procedural and financial considerations. The decision making process leading to a successful result using a single occlusive device is presented, alongside a review of the literature.

Perventricular double-device closure of wide-spaced multi-hole perimembranous ventricular septal defect.

PubMed

Liang, Fei; Hongxin, Li; Zhang, Hai-Zhou; Wenbin, Guo; Zou, Cheng-Wei; Farhaj, Zeeshan

2017-04-17

Device closure of a wide-spaced multi-hole PmVSD is difficult to succeed in percutaneous approach. This study is to evaluate the feasibility, safety and efficacy of perventricular device closure of wide-spaced multi-hole PmVSD using a double-device implanting technique. Sixteen patients with wide-spaced multi-hole PmVSD underwent perventricular closure with two devices through an inferior median sternotomy approach under transesophageal echocardiographic guidance. The largest hole and its adjacent small holes were occluded with an optimal-sized device. The far-away residual hole was occluded with the other device using a probe-assisted delivery system. All patients were followed up for a period of 1 to 4 years to determine the residual shunt, atrioventricular block and the adjacent valvular function. The number of the holes of the PmVSD was 2 to 4. The maximum distance between the holes was 5.0 to 10.0 mm (median, 6.4 mm). The diameter of the largest hole was 2.5 to 7.0 mm (median, 3.6 mm). The success rate of double-device closure was 100%. Immediate residual shunts were found in 6 patients (38%), and incomplete right bundle branch block at discharge occurred in 3 cases (19%). Both complications decreased to 6% at 1-year follow-up. Neither of them had a severe device-related complication. Perventricular closure of a wide-spaced multi-hole PmVSD using a double-device implanting technique is feasible, safe, and efficacious. In multi-hole PmVSDs with the distance between the holes of more than 5 mm, double-device implantation may achieve a complete occlusion.

Transcatheter closure, mini-invasive closure and open-heart surgical repair for treatment of perimembranous ventricular septal defects in children: a protocol for a network meta-analysis.

PubMed

You, Tao; Yi, Kang; Ding, Zhao-Hong; Hou, Xiao-Dong; Liu, Xing-Guang; Wang, Xin-Kuan; Ge, Long; Tian, Jin-Hui

2017-06-21

Both transcatheter device closure and surgical repair are effective treatments with excellent midterm outcomes for perimembranous ventricular septal defects (pmVSDs) in children. The mini-invasive periventricular device occlusion technique has become prevalent in research and application, but evidence is limited for the assessment of transcatheter closure, mini-invasive closure and open-heart surgical repair. This study comprehensively compares the efficacy, safety and costs of transcatheter closure, mini-invasive closure and open-heart surgical repair for treatment of pmVSDs in children using Bayesian network meta-analysis. A systematic search will be performed using Chinese Biomedical Literature Database, China National Knowledge Infrastructure, PubMed, EMBASE.com and the Cochrane Central Register of Controlled Trials to include random controlled trials, prospective or retrospective cohort studies comparing the efficacy, safety and costs of transcatheter closure, mini-invasive closure and open-heart surgical repair. The risk of bias for the included prospective or retrospective cohort studies will be evaluated according to the risk of bias in non-randomised studies of interventions (ROBINS-I). For random controlled trials, we will use risk of bias tool from Cochrane Handbook version 5.1.0. A Bayesian network meta-analysis will be conducted using R-3.3.2 software. Ethical approval and patient consent are not required since this study is a network meta-analysis based on published trials. The results of this network meta-analysis will be submitted to a peer-reviewed journal for publication. CRD42016053352. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Feasibility and safety of a new generation of gore septal occluder device in children.

PubMed

Lombardi, Maristella; Tagliente, Maria R; Pirolo, Teodoro; Massari, Elena; Milella, Leonardo; Vairo, Ugo

2016-12-01

Transcatheter closure of an ostium secundum atrial septal defect (ASD) is now considered the standard care for most of children with the appropriate anatomy, and is a relatively well-tolerated procedure to reduce the clinical sequelae of ASD, with a low complication rate. The present case reports describe our clinical experience of the percutaneous closure of a secundum ASD in 10 children between December 2011 and November 2012, by means of a new generation of device, the GORE Septal Occluder device. The implantation was successful in all except two cases, the device being properly placed and deployed without malposition or embolization in the catheterization laboratory. No complications were related to the procedure. The successful implant was confirmed and no major adverse events were documented in the following 3-12 months. The new GORE Septal Occluder device appears to be a feasible, well-tolerated and successful tool for the closure of an ASD of 15 mm or less in childhood.

How to deal with atrial septal defect closure from right internal jugular vein: Role of venous-arterial circuit for sizing and over-the-wire device implantation.

PubMed

Butera, Gianfranco; Lovin, Nicusor; Basile, Domenica Paola

2017-01-01

Secundum atrial septum defect (ASD) is the most common congenital heart disease. It is usually treated by a transcatheter approach using a femoral venous access. In case of bilateral femoral vein occlusion, the internal jugular venous approach for ASD closure is an option, in particular in cases where ASD balloon occlusion test and sizing is needed. Here, we report on a new technique for ASD closure using a venous-arterial circuit from the right internal jugular vein to the femoral artery. Two patients (females, 4 and 10 years of age) had occlusion of both femoral veins because of a previous history of pulmonary atresia and intact ventricular septum, for which they underwent percutaneous radiofrequency perforation and balloon angioplasty. These subjects needed balloon occlusion test of a residual ASD to size the hole and to check for hemodynamic suitability to ASD closure. After performing a venous-arterial circuit, a 24 mm St Jude ASD sizing balloon catheter was advanced over the circuit and the defect closed for 15 min to check hemodynamics and size the defect. ASD was closed is hemodinamically suitable. This technique was safe and reliable. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Freestyle multiple propeller flap reconstruction (jigsaw puzzle approach) for complicated back defects.

PubMed

Park, Sung Woo; Oh, Tae Suk; Eom, Jin Sup; Sun, Yoon Chi; Suh, Hyun Suk; Hong, Joon Pio

2015-05-01

The reconstruction of the posterior trunk remains to be a challenge as defects can be extensive, with deep dead space, and fixation devices exposed. Our goal was to achieve a tension-free closure for complex defects on the posterior trunk. From August 2006 to May 2013, 18 cases were reconstructed with multiple flaps combining perforator(s) and local skin flaps. The reconstructions were performed using freestyle approach. Starting with propeller flap(s) in single or multilobed design and sequentially in conjunction with adjacent random pattern flaps such as fitting puzzle. All defects achieved tensionless primary closure. The final appearance resembled a jigsaw puzzle-like appearance. The average size of defect was 139.6 cm(2) (range, 36-345 cm(2)). A total of 26 perforator flaps were used in addition to 19 random pattern flaps for 18 cases. In all cases, a single perforator was used for each propeller flap. The defect and the donor site all achieved tension-free closure. The reconstruction was 100% successful without flap loss. One case of late infection was noted at 12 months after surgery. Using multiple lobe designed propeller flaps in conjunction with random pattern flaps in a freestyle approach, resembling putting a jigsaw puzzle together, we can achieve a tension-free closure by distributing the tension to multiple flaps, supplying sufficient volume to obliterate dead space, and have reliable vascularity as the flaps do not need to be oversized. This can be a viable approach to reconstruct extensive defects on the posterior trunk. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Management of a large atrial septal occluder embolized to the left ventricular outflow tract without the use of cardiac surgery.

PubMed

Loh, Joshua P; Satler, Lowell F; Slack, Michael C

2014-09-01

Transcatheter closure of secundum-type atrial septal defects (ASDs) using the AMPLATZER™ Septal Occluder (ASO) has been in use for more than a decade since its US Food and Drug Administration approval in 2001. Device embolization remains an uncommon complication, which can sometimes occur after the initial deployment. Previous reports of ASO devices embolized to the left ventricle have primarily been managed by open-heart surgical retrieval. We present a case of an ASO device embolized to the left ventricular outflow tract (LVOT) 18 hr after initial implantation, which was successfully retrieved percutaneously, followed by successful closure of the ASD using a larger device. © 2014 Wiley Periodicals, Inc.

Perforation of the right aortic valve cusp: complication of ventricular septal defect closure with a modified Rashkind umbrella.

PubMed

Vogel, M; Rigby, M L; Shore, D

1996-01-01

An 18-month-old boy with a perimembranous ventricular septal defect (VSD) had undergone transcatheter closure of the defect with a modified 17 mm Rashkind umbrella device at age 4 months (weight 3.8 kg). The clinical signs of a VSD persisted, and he developed aortic incompetence, first detected 5 months after the procedure, which progressed from mild to moderate. A three-dimensional echocardiographic study demonstrated that one of the four arms holding the umbrella was protruding into the aortic valve and had perforated the right aortic valve cusp. This diagnosis was confirmed at subsequent surgery. Surgical repair of the perforated right aortic valve leaflet was necessary. The umbrella was adherent to the tricuspid valve and could not be removed. Instead it was left in situ, but three of the stainless steel arms were cut off. When umbrella closure of a perimembranous VSD is undertaken, the close proximity of part of the distal umbrella to the aortic valve can lead to aortic regurgitation.

Transcatheter closure of atrial septal defects type 2 in children under 3 years of age.

PubMed

Knop, Mateusz T; Białkowski, Jacek; Szkutnik, Małgorzata; Fiszer, Roland; Smerdziński, Sebastian; Gałeczka, Michał; Litwin, Linda

2018-06-04

Atrial septal defect type II (ASD), according to current standards, is closed percutaneously usually after the child has reached the age of 4-5 years. There are limited data regarding such treatment in smaller infants. To evaluate feasibility, safety and efficacy of percutaneous ASD closure in children under 3 years of age. Overall group of 149 children < 3 years with hemodynamically significant ASD, who underwent effective transcatheter ASD closure in one tertiary center between 1999 and 2014 were included. Mean procedural age of treated children was 2,2 years and weight 12,5 kg. In all nitinol wire mesh devices were applied (mostly Amplatzer Septal Occluders). ASD was closed by standard technique (except few cases when left disc of implant was inserted initially into right pulmonary vein to prevent oblique position of the device). Complications related to the procedure were divided into major and minor ones. There were 97 children with a single ASD and 52 with double/multiple ASD. No death, no implant embolization, and one major complications occurred during procedure and in follow-up. ASD was completely closed in all but 8 patients with double/multiple ASD. Right ventricle diameter normalization occurred in all during 1 year follow-up. In majority of the patients in follow-up an acceleration of physical development and resolution of accompanying morbidity was observed. Percutaneous ASD device closure can be performer safely in children below 3 years of age with low risk of complication during and after the procedure.

On the feasibility of the computational modelling of the endoluminal vacuum-assisted closure of an oesophageal anastomotic leakage

PubMed Central

Bellomo, Facundo J.; Rosales, Iván; del Castillo, Luis F.; Sánchez, Ricardo; Turon, Pau

2018-01-01

Endoluminal vacuum-assisted closure (E-VAC) is a promising therapy to treat anastomotic leakages of the oesophagus and bowel which are associated with high morbidity and mortality rates. An open-pore polyurethane foam is introduced into the leakage cavity and connected to a device that applies a suction pressure to accelerate the closure of the defect. Computational analysis of this healing process can advance our understanding of the biomechanical mechanisms at play. To this aim, we use a dual-stage finite-element analysis in which (i) the structural problem addresses the cavity reduction caused by the suction and (ii) a new constitutive formulation models tissue healing via permanent deformations coupled to a stiffness increase. The numerical implementation in an in-house code is described and a qualitative example illustrates the basic characteristics of the model. The computational model successfully reproduces the generic closure of an anastomotic leakage cavity, supporting the hypothesis that suction pressure promotes healing by means of the aforementioned mechanisms. However, the current framework needs to be enriched with empirical data to help advance device designs and treatment guidelines. Nonetheless, this conceptual study confirms that computational analysis can reproduce E-VAC of anastomotic leakages and establishes the bases for better understanding the mechanobiology of anastomotic defect healing. PMID:29515846

The TopClosure® 3S System, for skin stretching and a secure wound closure.

PubMed

Topaz, Moris; Carmel, Narin-Nard; Silberman, Adi; Li, Ming Sen; Li, Yong Zhong

2012-07-01

The principle of stretching wound margins for primary wound closure is commonly practiced and used for various skin defects, leading at times to excessive tension and complications during wound closure. Different surgical techniques, skin stretching devices and tissue expanders have been utilized to address this issue. Previously designed skin stretching devices resulted in considerable morbidity. They were invasive by nature and associated with relatively high localized tissue pressure, frequently leading to necrosis, damage and tearing of skin at the wound margins. To assess the clinical effectiveness and performance and, to determine the safety of TopClosure® for gradual, controlled, temporary, noninvasive and invasive applications for skin stretching and secure wound closing, the TopClosure® device was applied to 20 patients for preoperative skin lesion removal and to secure closure of a variety of wound sizes. TopClosure® was reinforced with adhesives, staples and/or surgical sutures, depending on the circumstances of the wound and the surgeon's judgment. TopClosure® was used prior to, during and/or after surgery to reduce tension across wound edges. No significant complications or adverse events were associated with its use. TopClosure® was effectively used for preoperative skin expansion in preparation for dermal resection (e.g., congenital nevi). It aided closure of large wounds involving significant loss of skin and soft tissue by mobilizing skin and subcutaneous tissue, thus avoiding the need for skin grafts or flaps. Following surgery, it was used to secure closure of wounds under tension, thus improving wound aesthetics. A sample case study will be presented. We designed TopClosure®, an innovative device, to modify the currently practiced concept of wound closure by applying minimal stress to the skin, away from damaged wound edges, with flexible force vectors and versatile methods of attachment to the skin, in a noninvasive or invasive manner.

Alarm!!! A UFO inside the heart.

PubMed

Santoro, Giuseppe; Castaldi, Biagio; Iacono, Carola; Giugno, Luca; Gaio, Gianpiero; Russo, Maria G

2012-10-01

An 8-year-old asymptomatic child was referred for surgical repair of coronary sinus atrial septal defect resulting in significant left-to-right shunt and right chamber volume overload. The septal fenestration was located near to its drainage site into the right atrium. Due to this seemingly favourable anatomy, transcatheter closure of the septal defect was performed using an Amplatzer Septal Occluder device. The echocardiographic postprocedural evaluation imaged the occluding device almost perpendicular to the atrial septum, seemingly floating above the mitral valve orifice, like an alien spaceship inside the heart.

Piezosurgery for the repair of middle cranial fossa meningoencephaloceles.

PubMed

Acharya, Aanand N; Rajan, Gunesh P

2015-03-01

To describe the use of a piezosurgery medical device to perform a craniotomy and produce a split calvarial graft for the repair of middle cranial fossa meningoencephaloceles. Retrospective case review. Tertiary referral hospital. Ten consecutive patients undergoing middle cranial fossa approach for the repair of meningoencephaloceles. Therapeutic. Intraoperative and postoperative complications, success rate as defined by the ability to fashion a split calvarial graft that achieves complete closure of the tegmen defect. As a secondary outcome measure, evidence of integration of the split calvarial bone graft with the adjacent skull base was assessed. There were no intraoperative or postoperative complications. An appropriately sized calvarial bone graft was produced, and complete closure of the tegmen defect was achieved in all 10 cases. Computed tomography demonstrated evidence of integration of the bone graft in eight cases between 4 and 9 months after surgery. The piezosurgery medical device provides a safe and effective means by which the middle fossa craniotomy and split calvarial bone graft can be produced to repair defects of the middle fossa tegmen, with integration of the bone graft in the majority of cases.

Transcatheter closure of atrial septal defect with amplatzer septal occluder in adults: immediate, short, and intermediate-term results.

PubMed

Behjati, Mostafa; Rafiei, Mansour; Soltani, Mohammad Hossein; Emami, Mahmoud; Dehghani, Majid

2011-01-01

The transcatheter closure of the atrial septal defect (ASD) has become an alternative technique to surgical procedures. The aim of this study was to assess the immediate, short, and intermediate-term results of the transcatheter closure of the secundum ASD with the Amplatzer Septal Occluder (ASO) in adult Iranian patients. Between December 2004 and July 2008, the transcatheter closure of the ASD using the ASO was attempted in 58 consecutive, adult patients. The mean age of the patients was 37.1 ± 12.7 years (range = 19 - 75 years). All the procedures were performed under local anesthesia with transthoracic or transesophageal echocardiography and fluoroscopic guidance. The stretched diameter of the ASD was determined with a balloon sizing catheter, and device selection was based on and matched to the stretched diameter of the septal defect. Transthoracic echocardiography was performed immediately after the release of the device and before discharge. Further follow-up at one month, six months, and yearly thereafter included physical examination, electrocardiography, and transthoracic echocardiography. The mean ASD diameter, as measured by esophageal echocardiography, was 24.8 ± 5.4 mm (range = 13 - 34 mm). The mean stretched diameter, as measured by the balloon catheter, was 27.1 ± 6.4 mm (range = 12.5 - 39 mm). Deployment of the ASO was successful in 52 (89.6%) patients and failed in 6 (10.4%). Four patients experienced severe complications, 1 had tamponade requiring drainage, 2 had device embolization to the left atrium and right ventricular outflow tract, and 1 had late wire fracture (surgical removal and repair of the ASD). The position of two large devices (34 mm and 36 mm) was considered unsuitable and unstable after implantation and resulted in the removal of these devices. Minor complications included transient complete atrioventricular block in 1 patient, paroxysmal supra tachycardia in 3 patients, atrial flutter in 1 patient, and angina pectoris with transient ST elevation in 2 patients. The mean follow-up period was 32.5 ± 18.5 months. Echocardiography at 24 hours, 1 month, 6 months, and 12 months after the procedure showed residual shunts in 11 (21%), 3 (5.8%), 2 (3.8%), and 2 (3.8%) patients, respectively. At follow-up (12.8 months to 48.5 months, mean ± SD = 32.5 ± 18.5 months), complete closure was documented in 50 (96.2 %) of the 52 cases. At the end of the follow-up, 2 (3.8%) patients had residual shunts: The shunt was moderate in 1 (1.9%) patient and small in the other (1.9%). The overall success rate of the transcatheter closure of the ASD was 86% (50 of 58 cases). The transcatheter closure of the secundum ASD in our adult patient population using the ASO was associated with high degrees of success, minimal procedural complication rates, and excellent short and midterm results. The use of this device, however, requires thorough attention in that the procedure may be ineffective or the device may embolize. Further experience and long-term follow-up are required before a widespread clinical use can be recommended.

Hemolysis induced by PMIVSD occluder.

PubMed

Rao, D Sheshagiri; Barik, Ramachandra; Siva Prasad, Akula

2016-09-01

Hemolysis related to occluder, prosthetic valve, and prosthetic ring used for mitral valve annuloplasty are not very unusual. However, hemolysis related to transcathetor closure of post-myocardial infarction ventricular septal defect (PMIVSD) is infrequent. A close follow-up for spontaneous resolution with or without blood transfusion has been reported in a few cases. Occasionally, surgical retrieval is unavoidable or lifelong blood transfusion is required if surgery cannot be done because of higher risk. In this illustration, we have showed a close follow-up of a case of hemolysis induced by atrial septal occluder used for VSD closure after myocardial infarction. Despite successful device closure of PMIVSD which is difficult, a close watch is needed for complications like residual leak, device embolization, and hemolysis. Copyright © 2016 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

Variation in practice patterns in device closure of atrial septal defects and patent ductus arteriosus: An analysis of data from the IMproving Pediatric and Adult Congenital Treatment (IMPACT) registry.

PubMed

O'Byrne, Michael L; Kennedy, Kevin F; Rome, Jonathan J; Glatz, Andrew C

2018-02-01

Practice variation is a potentially important measure of healthcare quality. The IMPACT registry provides a representative national sample with which to study practice variation in trans-catheter interventions for congenital heart disease. We studied cases for closure of atrial septal defect (ASD) and patent ductus arteriosus (PDA) in IMPACT between January 1, 2011, and September 30, 2015, using hierarchical multivariate models studying (1) the distribution of indications for closure and (2) in patients whose indication for closure was left (LVVO) or right ventricular volume overload (RVVO), the factors influencing probability of closure of a small defect (either in size or in terms of the magnitude of shunt). Over the study period, 5233 PDA and 4459 ASD cases were performed at 77 hospitals. The indications for ASD closure were RVVO in 84% and stroke prevention in 13%. Indications for PDA closure were LVVO in 57%, endocarditis prevention in 36%, and pulmonary hypertension in 7%. There was statistically significant variability in indications between hospitals for PDA and ASD procedures (median rate ratio (MRR): 1.3 and 1.1; both P<.001). The proportion of cases for volume overload with a Qp:Qs <1.5:1 decreased with increasing PDA and ASD procedural volume (P=.04 and 0.05). For ASD, the proportion was higher at hospitals with a larger proportion of adult cases (P=.0007). There was significant variation in practice in the risk of closing PDA <2 mm for LVVO (MRR: 1.4, P<.001). There is measurable variation in transcatheter closure of PDA and ASD. Further research is necessary to study whether this affects outcomes or resource utilization. Copyright © 2017 Elsevier Inc. All rights reserved.

Hybrid approach for closure of muscular ventricular septal defects

PubMed Central

Haponiuk, Ireneusz; Chojnicki, Maciej; Jaworski, Radoslaw; Steffek, Mariusz; Juscinski, Jacek; Sroka, Mariusz; Fiszer, Roland; Sendrowska, Aneta; Gierat-Haponiuk, Katarzyna; Maruszewski, Bohdan

2013-01-01

Background The complexity of ventricular septal defects in early infancy led to development of new mini-invasive techniques based on collaboration of cardiac surgeons with interventional cardiologists, called hybrid procedures. Hybrid therapies aim to combine the advantages of surgical and interventional techniques in an effort to reduce the invasiveness. The aim of this study was to present our approach with mVSD patients and initial results in the development of a mini-invasive hybrid procedure in the Gdansk Hybrid Heartlink Programme (GHHP) at the Department of Pediatric Cardiac Surgery, Pomeranian Centre of Traumatology in Gdansk, Poland. Material/Methods The group of 11 children with mVSDs was enrolled in GHHP and 6 were finally qualified to hybrid trans-ventricular mVSD device closure. Mean age at time of hybrid procedure was 8.22 months (range: from 2.7 to 17.8 months, SD=5.1) and mean body weight was 6.3 kg (range: from 3.4 to 7.5 kg, SD=1.5). Results The implants of choice were Amplatzer VSD Occluder and Amplatzer Duct Occluder II (AGA Med. Corp, USA). The position of the implants was checked carefully before releasing the device with both transesophageal echocardiography and epicardial echocardiography. All patients survived and their general condition improved. No complications occurred. The closure of mVSD was complete in all children. Conclusions Hybrid procedures of periventricular muscular VSD closure appear feasible and effective for patients with septal defects with morphology unsuitable for classic surgical or interventional procedures. The modern strategy of joint cardiac surgical and interventional techniques provides the benefits of close cooperation between cardiac surgeon and interventional cardiologist for selected patients in difficult clinical settings. PMID:23892911

Lower Hospital Charges and Societal Costs for Catheter Device Closure of Atrial Septal Defects.

PubMed

Sanchez, Jessica N; Seckeler, Michael D

2017-10-01

Atrial septal defects (ASD) are among the most common congenital heart defects. As more ASDs are corrected by interventional catheterization instead of surgery, it is critical to understand the associated clinical and societal costs. The goal of this study was to use a national U.S. database to describe hospital charges and societal costs for surgical and catheter-based (ASD) closure. Retrospective review of hospital discharge data from the Kids' Inpatient Database from January 2010 to December 2012. The database was queried for admissions for <21 years old with ICD-9 procedure codes for surgical (35.51 or 35.61) or catheter (35.52) ASD closure; those with other cardiac conditions and/or additional cardiac procedures were excluded. Age, length of stay (LOS), and hospital charges and lost parental wages (societal costs) were compared between groups using t test or Mann-Whitney U test, as appropriate. Four hundred and eighty-six surgical and 305 catheter ASD closures were identified. LOS, hospital charges, and total societal costs were higher in surgical ASD compared to catheter ASD admissions (3.6 vs. 1.3 days, p < 0.001, $87,465 vs. $64,109, p < 0.001, and $90,000 vs. $64,966, p < 0.001, respectively). In this review of a large national inpatient database, we found that hospital and societal costs for surgical ASD closure are significantly higher than catheter ASD closure in the United States in the current era. Factors that likely contribute to this include longer LOS and longer post-operative recovery. Using "real-world" data, this study demonstrates a substantial cost advantage for catheter ASD closure compared to surgical.

Imaging Techniques in Percutaneous Cardiac Structural Interventions: Atrial Septal Defect Closure and Left Atrial Appendage Occlusion.

PubMed

Rodríguez Fernández, Antonio; Bethencourt González, Armando

2016-08-01

Because of advances in cardiac structural interventional procedures, imaging techniques are playing an increasingly important role. Imaging studies show sufficient anatomic detail of the heart structure to achieve an excellent outcome in interventional procedures. Up to 98% of atrial septal defects at the ostium secundum can be closed successfully with a percutaneous procedure. Candidates for this type of procedure can be identified through a systematic assessment of atrial septum anatomy, locating and measuring the size and shape of all defects, their rims, and the degree and direction of shunting. Three dimensional echocardiography has significantly improved anatomic assessments and the end result itself. In the future, when combined with other imaging techniques such as cardiac computed tomography and fluoroscopy, 3-dimensional echocardiography will be particularly useful for procedure guidance. Percutaneous closure of the left atrial appendage offers an alternative for treating patients with atrial fibrillation and contraindication for oral anticoagulants. In the future, the clinical focus may well turn to stroke prevention in selected patients. Percutaneous closure is effective and safe; device implantation is successful in 94% to 99% of procedures. However, the procedure requires an experienced cardiac structural interventional team. At present, 3-dimensional echocardiography is the most appropriate imaging technique to assess anatomy suitability, select device type and size, guide the procedure alongside fluoroscopy, and to follow-up the patient afterwards. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Hybrid procedure for Poland syndrome associated with a Gerbode-type defect.

PubMed

Gan, Changping; Hu, Jia; Luo, Shuhua; An, Qi; Lin, Ke

2014-11-01

Poland syndrome and Gerbode-type defect are both very rare congenital malformations. A combination of them is extremely uncommon and no literature has reported this before. We herein present a case of this combination in a 9-year-old boy. Besides the reconstruction of the chest wall, a device closure of the Gerbode-type defect was also planned due to the risk of infective endocarditis. In order to minimize the injury, an innovative hybrid therapeutic strategy was chosen to treat two anomalies simultaneously in one incision. © 2014 Japanese Teratology Society.

Traction-assisted Internal Negative Pressure Wound Therapy With Bridging Retention Sutures to Facilitate Staged Closure of High-risk Wounds Under Tension.

PubMed

DeFazio, Michael V; Economides, James M; Anghel, Ersilia L; Mathis, Ryan K; Barbour, John R; Attinger, Christopher E

2017-10-01

Loss of domain often complicates attempts at delayed wound closure in regions of high tension. Wound temporization with traction-assisted internal negative pressure wound therapy (NPWT), using bridging retention sutures, can minimize the effects of edema and elastic recoil that contribute to progressive tissue retraction over time. The investigators evaluated the safety and efficacy of this technique for complex wound closure. Between May 2015 and November 2015, 18 consecutive patients underwent staged reconstruction of complex and/or contaminated soft tissue defects utilizing either conventional NPWT or modified NPWT with instillation and continuous dermatotraction via bridging retention sutures. Instillation of antimicrobial solution was reserved for wounds containing infected/exposed hardware or prosthetic devices. Demographic data, wound characteristics, reconstructive outcomes, and complications were reviewed retrospectively. Eighteen wounds were treated with traction-assisted internal NPWT using the conventional (n = 11) or modified instillation (n = 7) technique. Defects involved the lower extremity (n = 14), trunk (n = 3), and proximal upper extremity (n = 1), with positive cultures identified in 12 wounds (67%). Therapy continued for 3 to 8 days (mean, 4.3 days), resulting in an average wound surface area reduction of 78% (149 cm² vs. 33 cm²) at definitive closure. Seventeen wounds (94%) were closed directly, whereas the remaining defect required coverage with a local muscle flap and skin graft. At final follow-up (mean, 12 months), 89% of wounds remained closed. In 2 patients with delayed, recurrent periprosthetic infection (mean, 7.5 weeks), serial debridement/hardware removal mandated free tissue transfer for composite defect reconstruction. Traction-assisted internal NPWT provides a safe and effective alternative to reduce wound burden and facilitate definitive closure in cases where delayed reconstruction of high-tension wounds is planned.

Successful transcatheter occlusion of an anomalous pulmonary vein with dual drainage to the left atrium.

PubMed

Wilson, W; Horlick, E; Benson, L

2015-06-01

We describe a case of a scimitar syndrome "variant" where dual drainage existed from the right upper and middle pulmonary veins to the inferior vena cava and left atrium. Device closure of the anomalous vein at the level of the connection to the IVC was successful in achieving diversion of pulmonary venous flow to the left atrium. Vigilance during work-up of anomalous pulmonary venous drainage (whether isolated or associated with other cardiac defects that may be amenable to device closure) is important to define the presence of dual connections to the left atrium, in which case a less-invasive transcatheter approach may be feasible. © 2015 Wiley Periodicals, Inc.

Nickel elution properties of contemporary interatrial shunt closure devices.

PubMed

Verma, Divya Ratan; Khan, Muhammad F; Tandar, Anwar; Rajasekaran, Namakkal S; Neuharth, Renée; Patel, Amit N; Muhlestein, Joseph B; Badger, Rodney S

2015-02-01

We sought to compare nickel elution properties of contemporary interatrial shunt closure devices in vitro. There are two United States Food and Drug Administration (FDA)-approved devices for percutaneous closure of secundum atrial septal defect: the Amplatzer septal occluder (ASO; St Jude Medical Corporation) and Gore Helex septal occluder (HSO; W.L. Gore & Associates). The new Gore septal occluder (GSO) device is in clinical trials. These are also used off-label for patent foramen ovale closure in highly selected patients. These devices have high nickel content. Nickel allergy is the most common reason for surgical device explantation. Nickel elution properties of contemporary devices remain unknown. We compared nickel elution properties of 4 devices - ASO, GSO, HSO, and sternal wire (SW) - while Dulbecco's phosphate-buffered saline (DPBS) served as control. Three samples of each device were submerged in DPBS. Nickel content was measured at 14 intervals over 90 days. Nickel elution at 24 hours, compared to control (0.005 ± 0.0 mg/L), was significantly higher for ASO (2.98 ± 1.65 mg/L; P=.04) and SW (0.03 ± 0.014 mg/L; P=.03). Nickel levels at 90 days, compared to control (0.005 ± 0.0 mg/L) and adjusting for multiple comparisons, were significantly higher for ASO (19.80 ± 2.30 mg/L; P=.01) and similar for HSO (P=.34), GSO (P=.34), and SW (P=.34). ASO had significantly higher nickel elution compared to HSO, GSO, and SW (P=.01). There is substantial variability in nickel elution; devices with less exposed nickel (HSO and GSO) have minimal elution. The safety of low nickel elution devices in patients with nickel allergy needs to be evaluated in prospective trials.

Longitudinal evaluation of P-wave dispersion and P-wave maximum in children after transcatheter device closure of secundum atrial septal defect.

PubMed

Grignani, Robert Teodoro; Tolentino, Kim Martin; Rajgor, Dimple Dayaram; Quek, Swee Chye

2015-06-01

Transcatheter device closure of the secundum atrial septal defect (ASD) in children prevents atrial arrhythmias in older age. However, the benefits of favourable atrial electrocardiographic markers in these children remain elusive. We aimed to review the electrocardiographic markers of atrial activity in a longitudinal fashion. We retrospectively reviewed longitudinal data of all children who underwent transcatheter device closure at the National University Hospital between 2004 and 2013. The inclusion criteria included the presence of a secundum-type ASD with left to right shunt and evidence of increased right ventricular volume load (Q p/Q s ratio >1.5 and/or right ventricular dilatation). A total of 25 patients with a mean follow-up of 44.7 ± 33.47 (7.3-117.4) months were included. P maximum and P dispersion decreased at 2 months, P amplitude at 1 week and remained so until last follow-up. A positive trend was seen with a correlation coefficient of +0.12 for P maximum, +0.08 for P dispersion and 0.34 for P amplitude. There was a higher baseline P amplitude and P dispersion in patients who were older than 10 years and a non-significant trend to support an increase in both P maximum (71.0 ± 8.8 vs. 73.2 ± 12.7), P dispersion (17.0 ± 6.5 vs. 22.0 ± 11.3) and P amplitude (0.88 ± 0.25 vs. 1.02 ± 0.23) in patients with an ASD more than 15 mm compared with an ASD <15 mm. There is reduction in both P maximum and P dispersion as early as 2 months, which persisted on follow-up. Earlier closure may result in more favourable electrocardiographic results.

Options for Closure of the Infected Abdomen

PubMed Central

Campbell, Chris A.; Rosenberger, Laura H.; Politano, Amani D.; Davies, Stephen W.; Riccio, Lin M.; Sawyer, Robert G.

2012-01-01

Abstract Background The infected abdomen poses substantial challenges to surgeons, and often, both temporary and definitive closure techniques are required. We reviewed the options available to close the abdominal wall defect encountered frequently during and after the management of complicated intra-abdominal infections. Methods A comprehensive review was performed of the techniques and literature on abdominal closure in the setting of intra-abdominal infection. Results Temporary abdominal closure options include the Wittmann Patch, Bogota bag, vacuum-assisted closure (VAC), the AbThera™ device, and synthetic or biologic mesh. Definitive reconstruction has been described with mesh, components separation, and autologous tissue transfer. Conclusion Reconstructing the infected abdomen, both temporarily and definitively, can be accomplished with various techniques, each of which is associated with unique advantages and disadvantages. Appropriate judgment is required to optimize surgical outcomes in these complex cases. PMID:23216525

Cost comparison of transcatheter and operative closures of ostium secundum atrial septal defects

PubMed Central

O’Byrne, Michael L.; Gillespie, Matthew J.; Shinohara, Russell T.; Dori, Yoav; Rome, Jonathan J.; Glatz, Andrew C.

2015-01-01

Background Clinical outcomes for transcatheter and operative closures of atrial septal defects (ASDs) are similar. Economic cost for each method has not been well described. Methods A single-center retrospective cohort study of children and adults <30 years of age undergoing closure for single secundum ASD from January 1, 2007, to April 1, 2012, was performed to measure differences in inflation-adjusted cost of operative and transcatheter closures of ASD. A propensity score weight-adjusted multivariate regression model was used in an intention-to-treat analysis. Costs for reintervention and crossover admissions were included in primary analysis. Results A total of 244 subjects were included in the study (64% transcatheter and 36% operative), of which 2% (n = 5) were ≥18 years. Crossover rate from transcatheter to operative group was 3%. Risk of reintervention (P = .66) and 30-day mortality (P = .37) were not significantly different. In a multivariate model, adjusted cost of operative closure was 2012 US $60,992 versus 2012 US $55,841 for transcatheter closure (P < .001). Components of total cost favoring transcatheter closure were length of stay, medications, and follow-up radiologic and laboratory testing, overcoming higher costs of procedure and echocardiography. Professional costs did not differ. The rate of 30-day readmission was greater in the operative cohort, further increasing the cost advantage of transcatheter closure. Sensitivity analyses demonstrated that costs of follow-up visits influenced relative cost but that device closure remained favorable over a broad range of crossover and reintervention rates. Conclusion For single secundum ASD, cost comparison analysis favors transcatheter closure over the short term. The cost of follow-up regimens influences the cost advantage of transcatheter closure. PMID:25965721

10 CFR 71.87 - Routine determinations.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 2 2012-01-01 2012-01-01 false Routine determinations. 71.87 Section 71.87 Energy NUCLEAR...; (c) Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects; (d) Any system for containing liquid is adequately sealed and has adequate...

10 CFR 71.87 - Routine determinations.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Routine determinations. 71.87 Section 71.87 Energy NUCLEAR...; (c) Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects; (d) Any system for containing liquid is adequately sealed and has adequate...

10 CFR 71.87 - Routine determinations.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Routine determinations. 71.87 Section 71.87 Energy NUCLEAR...; (c) Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects; (d) Any system for containing liquid is adequately sealed and has adequate...

10 CFR 71.87 - Routine determinations.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Routine determinations. 71.87 Section 71.87 Energy NUCLEAR...; (c) Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects; (d) Any system for containing liquid is adequately sealed and has adequate...

10 CFR 71.87 - Routine determinations.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Routine determinations. 71.87 Section 71.87 Energy NUCLEAR...; (c) Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects; (d) Any system for containing liquid is adequately sealed and has adequate...

A comparison of the in vivo neoendothelialization and wound healing processes of three atrial septal defect occluders used during childhood in a nonrandomized prospective trial

PubMed Central

Şahin, Derya Aydın; Başpınar, Osman; Sülü, Ayşe; Karslıgil, Tekin; Kul, Seval

2017-01-01

Objective: We prospectively investigated the neoendothelialization of transcatheter secundum atrial septal defect (ASD) closure in children receiving one of three different occluders. Methods: Transcatheter ASD closure was performed for 44 children. The patients were divided into three groups: group I: Amplatzer, group II: Lifetech CeraFlex, and group III: Occlutech Figulla Flex II septal occluder. The data were prospectively analyzed. Markers of the three phases of wound healing were studied in all patients before and on the 1st and 10th days and 1st month post intervention. Results: The mean age of children was 7.08±3.51 years, and the mean weight was 26.07±15.07 kg. The mean ASD diameter was 12.65±3.50 mm. Groups I, II, and III comprised 34.1%, 31.8%, and 34.1% patients, respectively. No significant differences were observed between the groups regarding patient number, age, defect size, device diameter, or total septum/device ratio (p>0.05). Inflammatory and proliferative phase marker levels increased following the procedure (p<0.05). However, scar formation markers did not change after 1 month. No significant differences in neoendothelializaton were observed among the different occluders (p>0.05). Conclusion: All three devices were composed of nitinol with different surface coating techniques. Although the different manufacturing features were claimed to facilitate of neoendothelialization, no differences were observed among the three devices 1 month following the procedure. PMID:28761023

Health-Related Quality-of-Life after Laparoscopic Gastric Bypass Surgery with or Without Closure of the Mesenteric Defects: a Post-hoc Analysis of Data from a Randomized Clinical Trial.

PubMed

Stenberg, Erik; Szabo, Eva; Ottosson, Johan; Thorell, Anders; Näslund, Ingmar

2018-01-01

Mesenteric defect closure in laparoscopic gastric bypass surgery has been reported to reduce the risk for small bowel obstruction. Little is known, however, about the effect of mesenteric defect closure on patient-reported outcome. The aim of the present study was to see if mesenteric defect closure affects health-related quality-of-life (HRQoL) after laparoscopic gastric bypass. Patients operated at 12 centers for bariatric surgery participated in this randomized two-arm parallel study. During the operation, patients were randomized to closure of the mesenteric defects or non-closure. This study was a post-hoc analysis comparing HRQoL of the two groups before surgery, at 1 and 2 years after the operation. HRQoL was estimated using the short form 36 (SF-36-RAND) and the obesity problems (OP) scale. Between May 1, 2010, and November 14, 2011, 2507 patients were included in the study and randomly assigned to mesenteric defect closure (n = 1259) or non-closure (n = 1248). In total, 1619 patients (64.6%) reported on their HRQoL at the 2-year follow-up. Mesenteric defect closure was associated with slightly higher rating of social functioning (87 ± 22.1 vs. 85 ± 24.2, p = 0.047) and role emotional (85 ± 31.5 vs. 82 ± 35.0, p = 0.027). No difference was seen on the OP scale (open defects 22 ± 24.8 vs. closed defects 20 ± 23.8, p = 0.125). When comparing mesenteric defect closure with non-closure, there is no clinically relevant difference in HRQoL after laparoscopic gastric bypass surgery.

Magnetic resonance imaging study of eye congenital birth defects in mouse model

PubMed Central

Tucker, Zachary; Mongan, Maureen; Meng, Qinghang; Xia, Ying

2017-01-01

Purpose Embryonic eyelid closure is a well-documented morphogenetic episode in mammalian eye development. Detection of eyelid closure defect in humans is a major challenge because eyelid closure and reopen occur entirely in utero. As a consequence, congenital eye defects that are associated with failure of embryonic eyelid closure remain unknown. To fill the gap, we developed a mouse model of defective eyelid closure. This preliminary work demonstrates that the magnetic resonance imaging (MRI) approach can be used for the detection of extraocular muscle abnormalities in the mouse model. Methods Mice with either normal (Map3k1+/−) or defective (Map3k1−/−) embryonic eyelid closure were used in this study. Images of the extraocular muscles were obtained with a 9.4 T high resolution microimaging MRI system. The extraocular muscles were identified, segmented, and measured in each imaging slice using an in-house program. Results In agreement with histological findings, the imaging data show that mice with defective embryonic eyelid closure develop less extraocular muscle than normal mice. In addition, the size of the eyeballs was noticeably reduced in mice with defective embryonic eyelid closure. Conclusions We demonstrated that MRI can potentially be used for the study of extraocular muscle in the mouse model of the eye open-at-birth defect, despite the lack of specificity of muscle group provided by the current imaging resolution. PMID:28848319

A Large Multicenter Experience With Endoscopic Suturing for Management of Gastrointestinal Defects and Stent Anchorage in 122 Patients: A Retrospective Review.

PubMed

Sharaiha, Reem Z; Kumta, Nikhil A; DeFilippis, Ersilia M; Dimaio, Christopher J; Gonzalez, Susana; Gonda, Tamas; Rogart, Jason; Siddiqui, Ali; Berg, Paul S; Samuels, Paul; Miller, Larry; Khashab, Mouen A; Saxena, Payal; Gaidhane, Monica R; Tyberg, Amy; Teixeira, Julio; Widmer, Jessica; Kedia, Prashant; Loren, David; Kahaleh, Michel; Sethi, Amrita

2016-01-01

To describe a multicenter experience using an endoscopic suturing device for management of gastrointestinal (GI) defects and stent anchorage. Endoscopic closure of GI defects including perforations, fistulas, and anastomotic leaks as well as stent anchorage has improved with technological advances. An endoscopic suturing device (OverStitch; Apollo Endosurgery Inc.) has been used. Retrospective study of consecutive patients who underwent endoscopic suturing for management of GI defects and/or stent anchorage were enrolled between March 2012 and January 2014 at multiple academic medical centers. Data regarding demographic information and outcomes including long-term success were collected. One hundred and twenty-two patients (mean age, 52.6 y; 64.2% females) underwent endoscopic suturing at 8 centers for stent anchorage (n=47; 38.5%), fistulas (n=40; 32.7%), leaks (n=15; 12.3%), and perforations (n=20; 16.4%). A total of 44.2% underwent prior therapy and 97.5% achieved technical success. Immediate clinical success was achieved in 79.5%. Long-term clinical success was noted in 78.8% with mean follow-up of 68 days. Clinical success was 91.4% in stent anchorage, 93% in perforations, 80% in fistulas, but only 27% in anastomotic leak closure. Endoscopic suturing for management of GI defects and stent anchoring is safe and efficacious. Stent migration after stent anchoring was reduced compared with published data. Long-term success without further intervention was achieved in the majority of patients. The role of endoscopic suturing for repair of anastomotic leaks remains unclear given limited success in this retrospective study.

Pulmonary artery closure in combination with patch technique for treating congenital heart disease combined with large patent ductus arteriosus: A clinical study of 9 cases

PubMed Central

Wen, Bing; Yang, Junya; Liu, Huiruo; Jiao, Zhouyang; Zhao, Wenzeng

2016-01-01

Objective: To document clinical experience of treating congenital heart disease combined with large patent ductus arteriosus with pulmonary artery closure in combination with patch technique. Methods: Thirty-six patients (8 males and 28 females) who suffered from congenital heart disease and underwent hybrid surgery in the First Affiliated Hospital of Zhengzhou University from October 2010 to February 2014 were selected for this study. They aged 14 to 39 years and weighed 32.20 to 61.50 kg. Diameter of arterial duct was between 10 mm and 13 mm; 28 cases were tube type, 4 cases were funnel type and four cases were window type. All patients had moderate or severe pulmonary arterial hypertension; besides, there were 28 cases of ventricular septal defect, 16 cases of atrial septal defect, eight cases of aortic insufficiency, four cases of mitral stenosis and insufficiency and four cases of infectious endocarditis. Cardz Pulmonary Bypass (CPB) was established after chest was opened along the middle line. With the help of Transesophageal echocardiography, large patent ductus arteriosus was blocked off through pulmonary artery. Pulmonary artery was cut apart after blocking of heart. Large patent ductus arteriosus on the side of pulmonary artery was strengthened with autologous pericardial patch. Results: Of 36 patients, 32 patients had patent ductus arteriosus closure device and four patients had atrial septal defect closure device. Pulmonary arteries of 36 cases were all successfully closed. Systolic pressure declined after closure ((54.86±19.23) mmHg vs (96.05±23.07) mmHg, p<0.05); average pulmonary arterial pressure also declined after closure ((39.15±14.83) mmHg vs (72.88±15.76) mmHg, p<0.05). The patients were followed up for one to fifty one months (average 11.5 months). Compared to before surgery, left atrial diameter, left ventricular diameter and pulmonary artery diameter all narrowed after surgery. Besides, clinical symptoms were relieved and cardiac function of the patients also improved. Conclusion: Hybrid surgery is feasible and safe in treating patients with large patent ductus arteriosus and congenital heart disease, which decreases surgical problems, shortens surgical time and lowers the incidence of complications. PMID:27375685

Pulmonary artery closure in combination with patch technique for treating congenital heart disease combined with large patent ductus arteriosus: A clinical study of 9 cases.

PubMed

Wen, Bing; Yang, Junya; Liu, Huiruo; Jiao, Zhouyang; Zhao, Wenzeng

2016-01-01

To document clinical experience of treating congenital heart disease combined with large patent ductus arteriosus with pulmonary artery closure in combination with patch technique. Thirty-six patients (8 males and 28 females) who suffered from congenital heart disease and underwent hybrid surgery in the First Affiliated Hospital of Zhengzhou University from October 2010 to February 2014 were selected for this study. They aged 14 to 39 years and weighed 32.20 to 61.50 kg. Diameter of arterial duct was between 10 mm and 13 mm; 28 cases were tube type, 4 cases were funnel type and four cases were window type. All patients had moderate or severe pulmonary arterial hypertension; besides, there were 28 cases of ventricular septal defect, 16 cases of atrial septal defect, eight cases of aortic insufficiency, four cases of mitral stenosis and insufficiency and four cases of infectious endocarditis. Cardz Pulmonary Bypass (CPB) was established after chest was opened along the middle line. With the help of Transesophageal echocardiography, large patent ductus arteriosus was blocked off through pulmonary artery. Pulmonary artery was cut apart after blocking of heart. Large patent ductus arteriosus on the side of pulmonary artery was strengthened with autologous pericardial patch. Of 36 patients, 32 patients had patent ductus arteriosus closure device and four patients had atrial septal defect closure device. Pulmonary arteries of 36 cases were all successfully closed. Systolic pressure declined after closure ((54.86±19.23) mmHg vs (96.05±23.07) mmHg, p<0.05); average pulmonary arterial pressure also declined after closure ((39.15±14.83) mmHg vs (72.88±15.76) mmHg, p<0.05). The patients were followed up for one to fifty one months (average 11.5 months). Compared to before surgery, left atrial diameter, left ventricular diameter and pulmonary artery diameter all narrowed after surgery. Besides, clinical symptoms were relieved and cardiac function of the patients also improved. Hybrid surgery is feasible and safe in treating patients with large patent ductus arteriosus and congenital heart disease, which decreases surgical problems, shortens surgical time and lowers the incidence of complications.

Evaluation of a new tension relief system for securing wound closure: A single-centre, Chinese cohort study

PubMed Central

Huahui, Zhang; Dan, Xue; Hongfei, Jiang; Hang, Hu; Chunmao, Han; Haitao, Ren; Jianxin, Yu; Zhiping, Tao

2016-01-01

BACKGROUND Wounds that have been closed under excessive tension, and skin defects that cannot be closed primarily, pose a daily challenge for the reconstructive surgeon. OBJECTIVE To evaluate a new tension relief system (TRS) device for skin stretching and secure wound closure. METHODS From September 2013 to March 2014, a consecutive series of 41 Chinese patients with 43 wounds were enrolled for application of 50 cycles of TRS therapy. TRS was used for two main clinical applications: closure of a variety of surgical/traumatic wounds; and securing wound closure after high-tension suture closure. Basic information and details regarding this therapy and its complications were recorded. Follow-up visits were conducted three to six months after wound closure. RESULTS Mean residual wound width decreased approximately 20% every two days during cycles of TRS therapy. Infection was the most common complication (five cases). Other complications included dehiscence (two cases) and pressure ulcer (one case). At the six-month follow-up visit, (21 wounds in 20 patients), both the extent of healing and the scar were acceptable. DISCUSSION There are no absolute contraindications to TRS therapy. The authors have formulated instructions for the prevention and treatment of the most common complications. CONCLUSIONS The results demonstrate that TRS therapy is a simple, effective method for primary closure of difficult wounds, and large skin and soft-tissue defects. Larger randomized studies are required to further evaluate of the effectiveness, indications, complications and cost effectiveness of this innovative TRS therapy. PMID:28439506

Use of an Amplatzer Device for Endoscopic Closure of a Large Bronchopleural Fistula following Lobectomy for a Stage I Squamous Cell Carcinoma.

PubMed

Ottevaere, A; Slabbynck, H; Vermeersch, P; Rogiers, P; Galdermans, D; De Droogh, E; Bedert, L

2013-01-01

Bronchopleural fistulas can occur as a rare but severe complication after pulmonary resection. Established guidelines for the proper treatment of patients with bronchopleural fistulas do not exist. Apart from attempts to close the fistula, emphasis is placed on preventive measures, early treatment with antibiotics, drainage of the empyema and aggressive nutritional and rehabilitative support. For inoperable patients, endoscopic procedures are the only therapeutic option. Unfortunately, large (>8 mm) or central bronchopleural fistulas are usually not suitable for such endoscopic management. Recently, some groups have published a few case reports about a novel technique for the endobronchial closure of bronchopleural fistulas, using an Amplatzer device, originally designed for transcatheter closure of cardiac septal defects. We applied the same technique as a life-saving treatment in a ventilated patient who was considered inoperable due to a high oxygen need. The operation was successful. The patient could be weaned from ventilation and was eventually discharged from the hospital to a rehabilitation facility several weeks after the insertion of the device. Until now, endoscopic techniques have only been useful for the treatment of small, peripheral, bronchopleural fistulas and even then only as a bridge to surgery in high-risk surgical patients. In this case report, we demonstrate that the use of an Amplatzer device can expand the importance of endoscopic techniques in the treatment of bronchopleural fistulas. An Amplatzer device, for endobronchial closure, can indeed be administered for large and central bronchopleural fistulas. Moreover, it can be considered as a definite alternative to surgery in inoperable patients.

Delayed closure of the palatal defect using buccal inversion and palatal rotation flaps after maxillectomy.

PubMed

Jung, Seunggon; Kook, Min-Suk; Park, Hong-Ju; Oh, Hee-Kyun

2013-03-01

Maxillectomy leaves oronasal and oroantral defects that result in functional impairment of mastication, deglutition, and speech. Many treatment options are suggested and tried including the palatal flap as local flap. Although palatal flaps have been used to repair various oral cavity defects, they have certain limitations due to the dimensions. The amount and location of the palatal tissues available are important for palatal repair. Secondary intentional healing after maxillectomy will allow the epithelialization of the defect margin adjacent to remained palate, and there will be more mucosa that is available for closure of the defect. We delayed the closure of the palatal defect, while the patient underwent prosthetic treatment for functional recovery in 5 maxillectomy patients. Delayed closure of palatal defect with local flap was done at 10.8 ± 7.9 months after the maxillectomy. While delayed closure in hemimaxillectomy patients left postoperative fistula, it provided separation of the oral cavity and nasal/sinus cavity and adequate surface for prosthesis in partial maxillectomy patients.

33 CFR 156.120 - Requirements for transfer.

Code of Federal Regulations, 2011 CFR

2011-07-01

... closure devices required by §§ 154.520 and 155.805 of this chapter; (g) The transfer system is attached to... hose has no unrepaired loose covers, kinks, bulges, soft spots, or any other defect which would permit....810(g) of this chapter or 46 CFR 39.40-3(c) is fitted between the facility vapor connection and the...

Transcranial Doppler quantification of residual shunt after percutaneous patent foramen ovale closure: correlation of device efficacy with intracardiac anatomic measures.

PubMed

Sorensen, Sherman G; Spruance, Spotswood L; Smout, Randall; Horn, Susan

2012-06-01

Percutaneous, mechanical closure of defects of the atrial septum fails to completely resolve shunting in up to 20% of cases. Little is known about the factors associated with device failure. We measured the left atrial opening (X), right atrial opening (Z), tunnel length (Y), septum secundum, device-septum primum separation, and tunnel compressibility of the patent foramen ovale (PFO) in 301 patients with cryptogenic neurological events, PFO anatomy, and severe Valsalva shunting (Spencer Grade 5-5+). All patients then underwent percutaneous closure with the GORE®HELEX Septal Occluder device and were evaluated at 3 months for residual shunt by transcranial Doppler (TCD). Severe residual Valsalva shunt (TCD Grade 5-5+) was found at 3 months in 21 of 301 (7%) patients. X, Y, and Z were associated with failure with a high degree of statistical significance, whereas the width of the septum secundum, device-septum primum separation, and tunnel compressibility were not. An unanticipated finding was that 14 of 35 (40%) patients sized with a large balloon failed compared with 9 of 280 (3%) sized with a small balloon (P < 0.0001). In the multivariate logistic regression model, X (P = < 0.0001) and balloon size (P < 0.0001) were both strong predictors of failure. In an intracardiac echocardiography-defined PFO population, characterized by severe baseline Valsalva shunt and a high incidence of persistent (rest) shunting, association of six intracardiac measurements to closure device failure by multivariate logistic regression showed that the width of the left atrial opening was a strong predictor of residual shunting. An unanticipated finding was that use of a large sizing balloon was also strongly associated with failure. ©2012, Wiley Periodicals, Inc.

Stapler-assisted closure in total laryngectomy.

PubMed

Anand, Akash G

2013-01-01

The total laryngectomy is a surgical procedure that requires technically sound reconstruction in order to preserve a patient's swallowing function. Traditionally, a handsewn technique has been utilized to accomplish this endeavor. Recent applications of surgical stapling devices have been noted in an attempt to circumvent the need for handsewn reconstruction. This paper documents the application of a surgical stapling device in reconstructing a total laryngectomy defect. A brief review of the literature is provided to compare the differences between handsewn techniques and stapling techniques.

Use of the rhomboid flap after partial vulvectomy.

PubMed

Barnhill, D R; Hoskins, W J; Metz, P

1983-10-01

Primary closure of vulvar excisions is usually satisfactory in the anterior vulva, where the skin is mobile. In the posterior and posterolateral areas, however, closure often must be accomplished under tension with resulting wound breakdown and scar formation that can be disfiguring and cause dyspareunia. The rhomboid skin flap was described as early as 1946. Initially described for closure of facial defects, the technique has found application in the closure of a variety of traumatic and surgical defects. The authors present eight patients who underwent closure of vulvar defects using single or multiple rhomboid flaps. The applicability of the procedure to vulvar surgery is discussed and the technique is described.

Tissue loads applied by a novel medical device for closing large wounds.

PubMed

Katzengold, Rona; Topaz, Moris; Gefen, Amit

2016-02-01

Closure of large soft tissue defects following surgery or trauma as well as closure of large chronic wounds constitutes substantial but common reconstructive challenges. In such cases, an attempt to use conventional suturing will result in high-tension closure, therefore alternative external skin stretching systems were developed. These types of devices were meant to reduce local mechanical loads in the skin and the underlying tissues, taking advantage of the viscoelastic properties of the skin, especially mechanical creep, for primary wound closure. Studies have shown the clinical advantages of skin stretching systems, however, quantitative bioengineering models, demonstrating closure of large wounds, are lacking. Here we present finite element (FE) modeling of the TopClosure(®) tension relief system (TRS) and its biomechanical efficacy in three (real) wound cases, compared with the alternative of a conventional surgical suturing closure technique. Our simulations showed that peak effective stresses on the skin were at least an order of magnitude greater (and sometimes nearly 2 orders-of-magnitude greater) when tension sutures were used with respect to the corresponding TRS data. For the tension suture simulations, the tensile stress was in the range of 415-648 MPa and in the TRS simulations, it was 16-30 MPa. Based on the present computational FE modeling, the TRS reduces localized tissue deformations and stress concentrations in skin and underlying tissues while closing large wounds, compared to the deformations and stresses that are inflicted during the process of suturing. This substantial reduction of loads allows surgeons to better employ the viscoelastic properties of the skin for primary wound closure. Copyright © 2015 Tissue Viability Society. Published by Elsevier Ltd. All rights reserved.

Ischemic stroke occurring during intercourse in young women on oral contraceptives.

PubMed

Miller, P Elliott; Brown, Lorrel; Khandheria, Paras; Resar, Jon R

2014-08-01

Ischemic stroke occurring during intercourse in young patients is exceedingly rare. We present 2 cases of young women taking oral contraceptives, each presenting with an ischemic stroke. Transthoracic echocardiography revealed a patent foramen ovale in one patient and an atrial septal defect in the other. The most likely cause of stroke in both patients is embolic. Despite conflicting evidence, young patients presenting with ischemic stroke and found to have a patent foramen ovale or atrial septal defect should be considered for possible device-based closure. Copyright © 2014 Elsevier Inc. All rights reserved.

[Intracardiac echocardiography during percutaneous closure of atrial septal defect and patent foramen ovale].

PubMed

Brochet, E; Habib, G

2005-06-01

Intracardiac echocardiography is a new technique based on the use of ultrasonic diagnostic catheters. The most significant current experience has been obtained with the AcuNav catheter, with a "phased array" high frequency (5.5 to 10 mHz) detector, which obtains bidimensional echocardiographic views, coupled to pulsed and colour Doppler. Image acquisition is made from an intracardiac position, usually the right atrium. This review touches on the technical aspects of this method, applied to the examination of the intra-atrial septum, as well as the results currently obtained during inter-atrial communication and patent foramen ovale closure procedures. In effect it is in this field of application that intracardiac ultrasound has now found its niche, providing equivalent information to the reference technique of transoesophageal echocardiography. Intracardiac echocardiography allows complete examination of the inter-atrial septum and septal defects, as well as accurate surveillance of the positioning of percutaneous closure devices. An important advantage of intracardiac echocardiography is the possibility of avoiding a general anaesthetic, usually necessary with the transoesophageal route. At present, the main limiting factor to its systematic use is its high cost, linked to the single use catheters.

Failure of mesenteric defect closure after Roux-en-Y gastric bypass.

PubMed

Hope, William W; Sing, Ronald F; Chen, Albert Y; Lincourt, Amy E; Gersin, Keith S; Kuwada, Timothy S; Heniford, B Todd

2010-01-01

Bowel obstructions following Roux-en-Y gastric bypass (RYGB) are a significant issue often caused by internal herniation. Controversy continues as to whether mesenteric defect closure is necessary to decrease the incidence of internal hernias after RYGB. Our purpose was to evaluate the effectiveness of closing the mesenteric defect at the jejunojejunostomy in patients who underwent RYGB by examining this potential space at reoperation for any reason. We retrospectively reviewed medical records of patients undergoing surgery after RYGB from August 1999 to October 2008 to determine the status of the mesentery at the jejunojejunostomy. Eighteen patients underwent surgery 2 to 19 months after open (n=8) or laparoscopic (n=10) RYGB. All patients had documented suture closure of their jejunojejunostomy at the time of RYGB. Permanent (n=12) or absorbable (n=6) sutures were used for closures. Patients lost 23.6 kg to 62.1 kg before a reoperation was required for a ventral hernia (n=8), cholecystectomy (n=4), abdominal pain (n=4), or small bowel obstruction (n=2). Fifteen of the 18 patients had open mesenteric defects at the jejunojejunostomy despite previous closure; none were the cause for reoperation. Routine suture closure of mesenteric defects after RYGB may not be an effective permanent closure likely due to the extensive fat loss and weight loss within the mesentery.

Closed-chest transthoracic magnetic resonance imaging-guided ventricular septal defect closure in swine.

PubMed

Ratnayaka, Kanishka; Saikus, Christina E; Faranesh, Anthony Z; Bell, Jamie A; Barbash, Israel M; Kocaturk, Ozgur; Reyes, Christine A; Sonmez, Merdim; Schenke, William H; Wright, Victor J; Hansen, Michael S; Slack, Michael C; Lederman, Robert J

2011-12-01

The aim of this study was to close ventricular septal defects (VSDs) directly through the chest wall using magnetic resonance imaging (MRI) guidance, without cardiopulmonary bypass, sternotomy, or radiation exposure. Surgical, percutaneous, and hybrid management of VSD each have limitations and known morbidity. Percutaneous muscular VSDs were created in 10 naive Yorkshire swine using a transjugular laser catheter. Under real-time MRI guidance, a direct transthoracic vascular access sheath was introduced through the chest into the heart along a trajectory suitable for VSD access and closure. Through this transthoracic sheath, muscular VSDs were occluded using a commercial nitinol device. Finally, the right ventricular free wall was closed using a commercial collagen plug intended for arterial closure. Anterior, posterior, and mid-muscular VSDs (6.8 ± 1.8 mm) were created. VSDs were closed successfully in all animals. The transthoracic access sheath was displaced in 2, both fatal. Thereafter, we tested an intracameral retention sheath to prevent this complication. Right ventricular access ports were closed successfully in all, and after as many as 30 days, healed successfully. Real-time MRI guidance allowed closed-chest transthoracic perventricular muscular VSD closure in a clinically meaningful animal model. Once applied to patients, this approach may avoid traditional surgical, percutaneous, or open-chest transcatheter ("hybrid") risks. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Closed-Chest Transthoracic Magnetic Resonance Imaging-Guided Ventricular Septal Defect Closure in Swine

PubMed Central

Ratnayaka, Kanishka; Saikus, Christina E.; Faranesh, Anthony Z.; Bell, Jamie A.; Barbash, Israel M.; Kocaturk, Ozgur; Reyes, Christine A.; Sonmez, Merdim; Schenke, William H.; Wright, Victor J.; Hansen, Michael S.; Slack, Michael C.; Lederman, Robert J.

2012-01-01

Objectives The aim of this study was to close ventricular septal defects (VSDs) directly through the chest wall using magnetic resonance imaging (MRI) guidance, without cardiopulmonary bypass, sternotomy, or radiation exposure. Background Surgical, percutaneous, and hybrid management of VSD each have limitations and known morbidity. Methods Percutaneous muscular VSDs were created in 10 naive Yorkshire swine using a transjugular laser catheter. Under real-time MRI guidance, a direct transthoracic vascular access sheath was introduced through the chest into the heart along a trajectory suitable for VSD access and closure. Through this transthoracic sheath, muscular VSDs were occluded using a commercial nitinol device. Finally, the right ventricular free wall was closed using a commercial collagen plug intended for arterial closure. Results Anterior, posterior, and mid-muscular VSDs (6.8 ± 1.8 mm) were created. VSDs were closed successfully in all animals. The transthoracic access sheath was displaced in 2, both fatal. Thereafter, we tested an intracameral retention sheath to prevent this complication. Right ventricular access ports were closed successfully in all, and after as many as 30 days, healed successfully. Conclusions Real-time MRI guidance allowed closed-chest transthoracic perventricular muscular VSD closure in a clinically meaningful animal model. Once applied to patients, this approach may avoid traditional surgical, percutaneous, or open-chest transcatheter (“hybrid”) risks. PMID:22192373

Endoscopic closure of persistent gastrocutaneous fistulae, after percutaneous endoscopic gastrostomy (PEG) tube placement, using the over-the-scope-clip system

PubMed Central

Changela, Kinesh; Culliford, Andrea; Duddempudi, Sushil; Krishnaiah, Mahesh; Anand, Sury

2015-01-01

Objectives: The Over-The-Scope-Clip (OTSC) has had an evolving role in endoscopic closure of gastrointestinal wall defects, in hemostasis of primary or postinterventional bleeding, and approximation of postbariatric surgery defects. Rapid and effective closure of gastrocutaneous (GC) fistulae using this device has been recently described in the literature. The aim of this study was to evaluate the technical feasibility, efficacy and safety of OTSC as an effective tool in the management of persistent GC fistulae secondary to a complication of percutaneous endoscopic gastrostomy (PEG) tube placement. Method: In this multicenter prospective observational study, we describe our experience with OTSC in the closure of persistent GC fistulas secondary to PEG tube placement. Patients with GC fistulas were sequentially enrolled with a mean age of 84 years. Primary treatment outcome was the immediate successful closure of GC fistula and resolution of leak. Secondary outcome was no recurrence of the fistula and leaks on follow up. Results: A total of 10 patients were enrolled over the study period. Mean age was 84.4 ± 8.75 years. The primary treatment outcome was achieved in all the patients undergoing this intervention. Secondary outcome was observed in 9/10 (90%) subjects. No procedural complications were reported. Larger fistulae (>2.5 cm) and those with significant fibrosis were more difficult to close with the OTSC system. The mean follow-up time after OTSC application was 43.7 ± 20.57 days. A limitation of this study was that there was no control group. Conclusions: OTSC application is a safe and effective endoscopic approach for the closure of persistent GC fistulae secondary to a complication of PEG tube placement. PMID:26136836

Endoscopic closure of persistent gastrocutaneous fistulae, after percutaneous endoscopic gastrostomy (PEG) tube placement, using the over-the-scope-clip system.

PubMed

Singhal, Shashideep; Changela, Kinesh; Culliford, Andrea; Duddempudi, Sushil; Krishnaiah, Mahesh; Anand, Sury

2015-07-01

The Over-The-Scope-Clip (OTSC) has had an evolving role in endoscopic closure of gastrointestinal wall defects, in hemostasis of primary or postinterventional bleeding, and approximation of postbariatric surgery defects. Rapid and effective closure of gastrocutaneous (GC) fistulae using this device has been recently described in the literature. The aim of this study was to evaluate the technical feasibility, efficacy and safety of OTSC as an effective tool in the management of persistent GC fistulae secondary to a complication of percutaneous endoscopic gastrostomy (PEG) tube placement. In this multicenter prospective observational study, we describe our experience with OTSC in the closure of persistent GC fistulas secondary to PEG tube placement. Patients with GC fistulas were sequentially enrolled with a mean age of 84 years. Primary treatment outcome was the immediate successful closure of GC fistula and resolution of leak. Secondary outcome was no recurrence of the fistula and leaks on follow up. A total of 10 patients were enrolled over the study period. Mean age was 84.4 ± 8.75 years. The primary treatment outcome was achieved in all the patients undergoing this intervention. Secondary outcome was observed in 9/10 (90%) subjects. No procedural complications were reported. Larger fistulae (>2.5 cm) and those with significant fibrosis were more difficult to close with the OTSC system. The mean follow-up time after OTSC application was 43.7 ± 20.57 days. A limitation of this study was that there was no control group. OTSC application is a safe and effective endoscopic approach for the closure of persistent GC fistulae secondary to a complication of PEG tube placement.

Advances in the Surgical Treatment of Gastroschisis.

PubMed

Safavi, Arash; Skarsgard, Erik D

2015-05-01

Gastroschisis (GS) is a structural defect of the anterior abdominal wall, usually diagnosed antenatally, that occurs with a frequency of approximately 4 per 10,000 pregnancies. Babies born with GS require neonatal intensive care and surgical management of the abdominal wall defect soon after birth. Although contemporary survival rates for GS are over 90%, these babies are at risk for significant morbidity, and require 4 to 6 weeks of costly, resource-intensive care in specialized neonatal units. Much consideration has been given to how best to treat the abdominal wall defect of GS. The traditional approach, necessitated by a need to establish enteral feeding as quickly as possible, consists of early postnatal visceral reduction and sutured abdominal closure. Advances in neonatal nutritional support have enabled the development of surgical approaches, which permit gradual visceral reduction and delayed abdominal closure. In cases where early visceral reduction cannot be achieved, delayed closure enabled by the initial placement of a prosthetic silo has been a live-saving alternative. The development of preformed silos has simplified their use and led to an interest in treating all cases with a delayed closure philosophy. Most recently, a sutureless technique of abdominal closure has been reported, which has the benefit of avoiding general anesthesia and offers other outcome improvements over sutured closure of the defect. The debate over primary closure versus silo placement and delayed closure continues to receive much attention. The goal of this article is to review historical aspects of gastroschisis closure, and then focus on current surgical techniques, including the innovative sutureless closure, with an analysis of the comparative clinical effectiveness of these approaches to treatment of the abdominal wall defect in GS.

[Transcatheter closure of atrial septal defects in 40 pediatric patients].

PubMed

Deng, Dong-an; Zhu, Xian-yang; Hou, Chuan-ju; Han, Xiu-min; Wang, Qi-guang; Jin, Yan; Quan, Wei; Liu, Yang; Wang, Shu-fan

2003-07-01

To evaluate the clinical efficiency of transcatheter closure of atrial septal defect (ASD) with AGA-Amplatzer occlusion device in pediatric patients. Forty patients with ASD, 16 males, 24 females, at a mean age of 10.2 years (ranged from 3 to 15 years of age) and with a mean weight of 35.8 kg (ranged from 11 to 87 kg) were studied. Six cases were complicated with pulmonary stenosis (PS), 1 was complicated with ventricular tachycardia (VT). Right heart catheterizations were done in 40 patients for measuring the pressures of right ventricle and pulmonary artery. The balloon diameter of ASD was measured using balloon catheter with guiding wire. The diameter of ASD was measured by TTE and/or TEE, ascertaining the location and size of ASD. Amplatzer occlusion device was sized to be equal to or 1 - 2 mm more than the diameter of balloon stretched. All patients had successful implantation of the Amplatzer device. The success rate was 100%. The diameter measured by TTE was 7 - 30 mm (mean 17.12 mm). The diameter measured by TEE was 7 - 32 mm (mean 18.44 mm). The diameter of balloon stretched of ASD was 8 - 34 mm. Of the 40 cases, 6 were complicated with PS and accepted percutaneous balloon valvuloplasty (PBPV). One case was complicated with VT and accepted radiofrequency catheter ablation (RFCA). Neither complication nor residual shunt was found in any of the patients. The patients were recovered and followed up for 3 or 4 days after deployment of the Amplatzer device. Clinical symptom, cardiac murmur, and findings in ECG, echocardiography and X-ray were improved markedly. AGA-Amplatzer occlusion device is safe and efficient in pediatric patients with ASD.

Application of Cardio-O-Fix occluders for transcatheter closure of patent ductus arteriosus and interatrial communications: Preliminary experience.

PubMed

Białkowski, Jacek; Szkutnik, Małgorzata; Fiszer, Roland; Głowacki, Jan; Banaszak, Paweł; Zembala, Marian

2010-01-01

Transcatheter treatment has become the method of choice for treating many heart defects. Recently, Cardio-O-Fix occluder (COF) - a new, self-expandable nitinol wire-mesh device very similar to the Amplatzer device - has been introduced into clinical practice. To the best of our knowledge, this is the first publication related to its application. Five patients aged from six months to 69 years were included in the study: two with atrial septal defect (ASD), one with patent foramen ovale (PFO) after cryptogenic stroke, and two with patent ductus arteriosus (PDA). These latter two comprised one six month old infant with co-existent hypertrophied cardiomyopathy, and a 53 year-old woman with recanalized PDA after previous ligation. All were treated percutaneously with COF. There was no preliminary patient selection. The only limitation was the size of the devices in our possession (16 and 22 mm ASD COF, 25 PFO COF, 4/6 and 6/8 PDA COF). The implantation technique was the same as previously described for Amplatzer occluders. All procedures were finished successfully with complete closure of the shunt. No complications were observed during a six month follow-up. In the child with PDA, we observed decrease of gradient from 80 to 60 mm Hg in hypertrophied left ventricular outflow tract, although a small protrusion of PDA-COF device was noted in the descending aorta (8 mm Hg gradient in ECHO). In the patient with recanalized PDA, the procedure was performed after arterio-venous loop creation. Mean fluoroscopy time was 4.4 (range from 1.6 to 11) minutes. Our preliminary experience indicates that the application of Cardio-O-Fix devices is safe and effective.

Potential Therapeutic Use of Relaxin in Healing Cranial Bone Defects

DTIC Science & Technology

2016-08-01

successful production of chimeric mice after irradiation and GFP+ bone marrow transplantation; reproducible implementation of uniform cranial lesions of ~1.5...cranial defect model in chimeric mice transplanted with GFP+ bone marrow. We follow defect closure by three dimensional microcomputed tomography (µCT...histolomorphometry and immunohistochemistry, respectively. 2. Keywords GFP+ chimeric mice, cranial defect closure, relaxin, angiogenesis

A comparison of techniques for myelomeningocele defect closure in the neonatal period.

PubMed

Kobraei, Edward M; Ricci, Joseph A; Vasconez, Henry C; Rinker, Brian D

2014-09-01

Numerous techniques have been described for repair of myelomeningoceles, but outcome data is scarce. A retrospective review was performed in 32 consecutive patients who underwent neonatal myelomeningocele repair and extra-dural closure to determine the influence of repair type on outcome. All procedures for myelomeningocele closure were classified into one of three groups, which included primary closure, myocutaneous flaps, and fasciocutaneous flaps. Defect size ranged from 1 to 48 cm(2). Primary skin closure was performed in 3 patients, fasciocutaneous flaps in 13 patients, and myocutaneous flaps in 16 patients. The overall complication rate was 18%. No difference in the complication rates among the primary closure, myocutaneous, and fasciocutaneous flap groups was observed in our analysis. While not statistically significant, our data documents an association of fasciocutaneous flaps with postoperative complications that were not evident with primary skin closure or myocutaneous flaps (odds ratio 3.8; p = 0.15). The occurrence of one or more complications was associated with a longer hospital stay. Myocutaneous flaps provide a secure repair and should be considered for smaller myelomeningocele defects in addition to the larger defects where they are more traditionally used. We propose a tissue-based classification of closure techniques strictly for multi-institution outcome comparison that may ultimately inform clinical decision-making.

Evaluation of right ventricular function in early period following transcatheter closure of atrial septal defect.

PubMed

Ağaç, Mustafa Tarık; Akyüz, Ali Rıza; Acar, Zeydin; Akdemir, Ramazan; Korkmaz, Levent; Kırış, Abdülkadir; Erkuş, Emre; Erkan, Hakan; Celik, Sükrü

2012-03-01

There is limited data on alterations in novel right ventricular (RV) function indices like tricuspid annular plane systolic excursion (TAPSE) and tricuspid annular systolic velocity (TASV) after transcatheter atrial septal defect (ASD) closure. We aimed to evaluate RV function by echocardiography (ECG) with these novel indices in early period in patients with secundum-type ASD that was closed percutaneously. Patients were enrolled to study if they had secundum-type ASD that was suitable for percutaneous closure. Patient population consisted of 4 men and 16 women. Echocardiography was performed before and 1 month after closure. Mean age was 37 ± 16. Mean diameter of ASD and total atrial septum length measured by ECG were 19 ± 6 mm and 49 ± 7 mm, respectively. Mean diameter of defect in transesophageal echocardiography was 20 ± 6 mm. Stretched mean diameter in catheterization was 23 ± 6 mm. One month after closure, there were statistically significant decreases in RV end-diastolic diameters (43.3 ± 10.7 mm vs. 34.9 ± 5.5 mm; P < 0.001), RV/left ventricular (LV) end-diastolic diameter ratio (1.1 ± 0.3 vs. 0.87 ± 0.1; P < 0.001), TASV (16.9 ± 3.2 cm/sec vs. 14.3 ± 3.3 cm/sec; P < 0.05), early diastolic tricuspid annular velocity (15.3 ± 3.1 cm/sec vs. 13.4 ± 2.4 cm/sec P <0.05), late diastolic tricuspid annular velocity (16.2 ± 5.4 cm/sec vs. 14.3 ± 6.3 cm/sec; P < 0.05), and TAPSE (29.9 ± 6.2 mm vs. 22.4 ± 7.4 mm; P < 0.001). LV end-diastolic diameter (38.0 ± 6.9 mm and 40.0 ± 4.5 P < 0.05) was increased, whereas there was no change in LV ejection fraction. Closure of ASD by using Amplatzer devices led to decrease in right heart chamber size, tissue Doppler-derived tricuspid annular velocities and TAPSE in early period. © 2011, Wiley Periodicals, Inc.

Percutaneous closure of a post-traumatic ventricular septal defect with a patent ductus arteriosus occluder.

PubMed

Xi, Er-Ping; Zhu, Jian; Zhu, Shui-Bo; Yin, Gui-Lin; Liu, Yong; Dong, Yong-Qiang; Zhang, Yu; Xia, Feng

2012-11-01

Ventricular septal defects resulting from post-traumatic cardiac injury are very rare. Percutaneous closure has emerged as a method for treating this disorder. We wish to report our experience in three patients who underwent percutaneous closure of a post-traumatic ventricular septal defect with a patent ductus arteriosus occluder. We treated three patients with post-traumatic ventricular septal defects caused by stab wounds with knives. After the heart wound was repaired, patient examinations revealed ventricular septal defects with pulmonary/systemic flow ratios (Qp/Qs) of over 1.7. The post-traumatic ventricular septal defects were closed percutaneously with a patent ductus arteriosus occluder (Lifetech Scientific (Shenzhen) Co., LTD, Guangdong, China) utilizing standard techniques. Post-operative transthoracic echocardiography revealed no residual left-to-right shunt and indicated normal ventricular function. In addition, 320-slice computerized tomography showed that the occluder was well placed and exhibited normal morphology. Our experiences indicate that closure of a post-traumatic ventricular septal defect using a patent ductus arteriosus occluder is feasible, safe, and effective.

Percutaneous closure of a post-traumatic ventricular septal defect with a patent ductus arteriosus occluder

PubMed Central

Xi, Er-Ping; Zhu, Jian; Zhu, Shui-Bo; Yin, Gui-Lin; Liu, Yong; Dong, Yong-Qiang; Zhang, Yu; Xia, Feng

2012-01-01

OBJECTIVE: Ventricular septal defects resulting from post-traumatic cardiac injury are very rare. Percutaneous closure has emerged as a method for treating this disorder. We wish to report our experience in three patients who underwent percutaneous closure of a post-traumatic ventricular septal defect with a patent ductus arteriosus occluder. METHODS: We treated three patients with post-traumatic ventricular septal defects caused by stab wounds with knives. After the heart wound was repaired, patient examinations revealed ventricular septal defects with pulmonary/systemic flow ratios (Qp/Qs) of over 1.7. The post-traumatic ventricular septal defects were closed percutaneously with a patent ductus arteriosus occluder (Lifetech Scientific (Shenzhen) Co., LTD, Guangdong, China) utilizing standard techniques. RESULTS: Post-operative transthoracic echocardiography revealed no residual left-to-right shunt and indicated normal ventricular function. In addition, 320-slice computerized tomography showed that the occluder was well placed and exhibited normal morphology. CONCLUSION: Our experiences indicate that closure of a post-traumatic ventricular septal defect using a patent ductus arteriosus occluder is feasible, safe, and effective. PMID:23184204

Single-site neural tube closure in human embryos revisited.

PubMed

de Bakker, Bernadette S; Driessen, Stan; Boukens, Bastiaan J D; van den Hoff, Maurice J B; Oostra, Roelof-Jan

2017-10-01

Since the multi-site closure theory was first proposed in 1991 as explanation for the preferential localizations of neural tube defects, the closure of the neural tube has been debated. Although the multi-site closure theory is much cited in clinical literature, single-site closure is most apparent in literature concerning embryology. Inspired by Victor Hamburgers (1900-2001) statement that "our real teacher has been and still is the embryo, who is, incidentally, the only teacher who is always right", we decided to critically review both theories of neural tube closure. To verify the theories of closure, we studied serial histological sections of 10 mouse embryos between 8.5 and 9.5 days of gestation and 18 human embryos of the Carnegie collection between Carnegie stage 9 (19-21 days) and 13 (28-32 days). Neural tube closure was histologically defined by the neuroepithelial remodeling of the two adjoining neural fold tips in the midline. We did not observe multiple fusion sites in neither mouse nor human embryos. A meta-analysis of case reports on neural tube defects showed that defects can occur at any level of the neural axis. Our data indicate that the human neural tube fuses at a single site and, therefore, we propose to reinstate the single-site closure theory for neural tube closure. We showed that neural tube defects are not restricted to a specific location, thereby refuting the reasoning underlying the multi-site closure theory. Clin. Anat. 30:988-999, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Mass extraction container closure integrity physical testing method development for parenteral container closure systems.

PubMed

Yoon, Seung-Yil; Sagi, Hemi; Goldhammer, Craig; Li, Lei

2012-01-01

Container closure integrity (CCI) is a critical factor to ensure that product sterility is maintained over its entire shelf life. Assuring the CCI during container closure (C/C) system qualification, routine manufacturing and stability is important. FDA guidance also encourages industry to develop a CCI physical testing method in lieu of sterility testing in a stability program. A mass extraction system has been developed to check CCI for a variety of container closure systems such as vials, syringes, and cartridges. Various types of defects (e.g., glass micropipette, laser drill, wire) were created and used to demonstrate a detection limit. Leakage, detected as mass flow in this study, changes as a function of defect length and diameter. Therefore, the morphology of defects has been examined in detail with fluid theories. This study demonstrated that a mass extraction system was able to distinguish between intact samples and samples with 2 μm defects reliably when the defect was exposed to air, water, placebo, or drug product (3 mg/mL concentration) solution. Also, it has been verified that the method was robust, and capable of determining the acceptance limit using 3σ for syringes and 6σ for vials. Sterile products must maintain their sterility over their entire shelf life. Container closure systems such as those found in syringes and vials provide a seal between rubber and glass containers. This seal must be ensured to maintain product sterility. A mass extraction system has been developed to check container closure integrity for a variety of container closure systems such as vials, syringes, and cartridges. In order to demonstrate the method's capability, various types of defects (e.g., glass micropipette, laser drill, wire) were created in syringes and vials and were tested. This study demonstrated that a mass extraction system was able to distinguish between intact samples and samples with 2 μm defects reliably when the defect was exposed to air, water, placebo, or drug product (3 mg/mL concentration) solution. Also, it was verified that the method showed consistent results, and was able to determine the acceptance limit using 3σ for syringes and 6σ for vials.

Minimally invasive or interventional repair of atrial septal defects in children: experience in 171 cases and comparison with conventional strategies.

PubMed

Formigari, R; Di Donato, R M; Mazzera, E; Carotti, A; Rinelli, G; Parisi, F; Pasquini, L; Ballerini, L

2001-05-01

The goal of this study was to evaluate percutaneous interventional and minimally invasive surgical closure of secundum atrial septal defect (ASD) in children. Concern has surrounded abandoning conventional midline sternotomy in favor of the less invasive approaches pursuing a better cosmetic result and a more rational resource utilization. A retrospective analysis was performed on the patients treated from June 1996 to December 1998. One hundred seventy-one children (median age 5.8 years, median weight 22.1 kg) underwent 52 device implants, 72 minimally invasive surgical operations and 50 conventional sternotomy operations. There were no deaths and no residual left to right shunt in any of the groups. The overall complication rate causing delayed discharge was 12.6% for minimally invasive surgery, 12.0% for midline sternotomy and 3.8% for transcatheter device closure (p < 0.01). The mean hospital stay was 2.8 +/- 1.0 days, 6.5 +/- 2.1 days and 2.1 +/- 0.5 days (p < 0.01); the skin-to-skin time was 196 +/- 43 min, 163 +/- 46 min and 118 +/- 58 min, respectively (p < 0.001). Extracorporeal circulation time was 49.9 +/- 10.1 min in the minithoracotomy group versus 37.2 +/- 13.8 min in the sternotomy group (p < 0.01) but without differences in aortic cross-clamping time. Sternotomy was the most expensive procedure (15,000 EUR +/- 1,050 EUR vs. 12,250 EUR +/- 472 EUR for minithoracotomy and 13,000 EUR +/- 300 EUR for percutaneous devices). While equally effective compared with sternotomy, the cosmetic and financial appeal of the percutaneous and minimally invasive approaches must be weighed against their greater exposure to technical pitfalls. Adequate training is needed if a strategy of surgical or percutaneous minimally invasive closure of ASD in children is planned in place of conventional surgery.

Utility and Scope of Rapid Prototyping in Patients with Complex Muscular Ventricular Septal Defects or Double-Outlet Right Ventricle: Does it Alter Management Decisions?

PubMed

Bhatla, Puneet; Tretter, Justin T; Ludomirsky, Achi; Argilla, Michael; Latson, Larry A; Chakravarti, Sujata; Barker, Piers C; Yoo, Shi-Joon; McElhinney, Doff B; Wake, Nicole; Mosca, Ralph S

2017-01-01

Rapid prototyping facilitates comprehension of complex cardiac anatomy. However, determining when this additional information proves instrumental in patient management remains a challenge. We describe our experience with patient-specific anatomic models created using rapid prototyping from various imaging modalities, suggesting their utility in surgical and interventional planning in congenital heart disease (CHD). Virtual and physical 3-dimensional (3D) models were generated from CT or MRI data, using commercially available software for patients with complex muscular ventricular septal defects (CMVSD) and double-outlet right ventricle (DORV). Six patients with complex anatomy and uncertainty of the optimal management strategy were included in this study. The models were subsequently used to guide management decisions, and the outcomes reviewed. 3D models clearly demonstrated the complex intra-cardiac anatomy in all six patients and were utilized to guide management decisions. In the three patients with CMVSD, one underwent successful endovascular device closure following a prior failed attempt at transcatheter closure, and the other two underwent successful primary surgical closure with the aid of 3D models. In all three cases of DORV, the models provided better anatomic delineation and additional information that altered or confirmed the surgical plan. Patient-specific 3D heart models show promise in accurately defining intra-cardiac anatomy in CHD, specifically CMVSD and DORV. We believe these models improve understanding of the complex anatomical spatial relationships in these defects and provide additional insight for pre/intra-interventional management and surgical planning.

Regional neural tube closure defined by the Grainy head-like transcription factors.

PubMed

Rifat, Yeliz; Parekh, Vishwas; Wilanowski, Tomasz; Hislop, Nikki R; Auden, Alana; Ting, Stephen B; Cunningham, John M; Jane, Stephen M

2010-09-15

Primary neurulation in mammals has been defined by distinct anatomical closure sites, at the hindbrain/cervical spine (closure 1), forebrain/midbrain boundary (closure 2), and rostral end of the forebrain (closure 3). Zones of neurulation have also been characterized by morphologic differences in neural fold elevation, with non-neural ectoderm-induced formation of paired dorso-lateral hinge points (DLHP) essential for neural tube closure in the cranial and lower spinal cord regions, and notochord-induced bending at the median hinge point (MHP) sufficient for closure in the upper spinal region. Here we identify a unifying molecular basis for these observations based on the function of the non-neural ectoderm-specific Grainy head-like genes in mice. Using a gene-targeting approach we show that deletion of Grhl2 results in failed closure 3, with mutants exhibiting a split-face malformation and exencephaly, associated with failure of neuro-epithelial folding at the DLHP. Loss of Grhl3 alone defines a distinct lower spinal closure defect, also with defective DLHP formation. The two genes contribute equally to closure 2, where only Grhl gene dosage is limiting. Combined deletion of Grhl2 and Grhl3 induces severe rostral and caudal neural tube defects, but DLHP-independent closure 1 proceeds normally in the upper spinal region. These findings provide a molecular basis for non-neural ectoderm mediated formation of the DLHP that is critical for complete neuraxis closure. (c) 2010 Elsevier Inc. All rights reserved.

A reliable and safe gastrotomy closure technique assessed in a porcine survival model pilot study: success of the Queen's closure.

PubMed

Hookey, L C; Bielawska, B; Samis, A; Jalink, D; Ellis, R; Khokhotva, V; Hurlbut, D; Mercer, D

2009-06-01

The evolution of NOTES to clinical implementation has been hampered by lack of a reliable, safe, and easy-to-implement technique for closure of the opening created in accessing the peritoneum. The Queen's closure uses a combination of endoscopic clips and loop devices to seal such defects in the stomach wall. This study aimed to assess the Queen's closure in a porcine survival model. Five 30-kg pigs underwent endoscopic transgastric surgery with exploration of the peritoneum. The endoscope was then withdrawn back into the stomach and the closure performed. The animals were recovered, monitored closely, and underwent endoscopy 1 week after surgery. They were then euthanized at 2 (n = 2) and 3 (n = 3) weeks after surgery with subsequent necropsy. The mean procedure time (from intubation of the esophagus to withdrawal of the endoscope) was 79 minutes (range 45-105 minutes) with a mean time of exploration of the peritoneum of 14 minutes (range 8-25 minutes). All animals recovered well with no apparent pain, distress, or signs of infection. Endoscopic examination 1 week after surgery revealed all the closures to be intact and only identifiable by a small ulcer. At necropsy, the gastrotomy site was identifiable only by minor serosal adhesions. Histological study demonstrated full-thickness closure with minimal inflammation. The Queen's closure is a reliable and safe technique that provides full-thickness gastrotomy closure without any observed complications. The technique has proven to be transferable knowledge that holds promise for clinical implementation.

Extradural myelomeningocele reconstruction using local turnover fascial flaps and midline linear skin closure.

PubMed

Patel, Kamlesh B; Taghinia, Amir H; Proctor, Mark R; Warf, Benjamin C; Greene, Arin K

2012-11-01

Myelomeningocele is the most common neural tube defect. Repair typically involves deep closure with regional muscle flaps (e.g. latissimus dorsi, gluteus maximus) and skin closure with rotation, bipedicle, or rhomboid flaps. We describe the reconstruction of large myelomeningocele defects using (1) local fascial turnover flaps with or without paraspinous muscle flaps for deep coverage of the dural repair followed by (2) linear, midline skin closure. Copyright © 2012 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Endoscopic repair of an injured internal carotid artery utilizing femoral endovascular closure devices.

PubMed

Van Rompaey, Jason; Bowers, Greg; Radhakrishnan, Jay; Panizza, Benedict; Solares, C Arturo

2014-06-01

Injury to the internal carotid artery is a feared complication of endoscopic endonasal surgery of the skull base. Such an event, although rare, is associated with high morbidity and mortality. Even if bleeding is controlled, permanent neurological defects frequently persist. Many techniques have been developed to manage internal carotid artery rupture with varying degrees of success. The purpose of this study was to explore endoscopic management of arterial damage with endovascular closure devices used for a femoral arteriotomy. The ability to remotely suture a damaged artery permits the possible adaptation of this technology in managing endoscopic arterial complications. Technical note. After the creation of an endoscopic endonasal corridor in a cadaveric specimen, an arteriotomy was created at the cavernous portion of the internal carotid artery. The Angio-Seal, StarClose, and MynxGrip vascular closure devices were utilized under endoscopic guidance to repair the arteriotomy. Angiography was then done on a cadaver sutured with the StarClose. Both the Angio-Seal and StarClose were deployed quickly and appeared to provide sufficient closure of the arteriotomy. The Angio-Seal required the use of a guidewire and was longer to deploy when compared with the StarClose. The StarClose deployment was quick and facile. The MynxGrip also deployed without difficulty. The Angio-Seal and StarClose systems were both successfully deployed utilizing an endoscopic endonasal approach. The MynxGrip was the easiest to deploy and has the greatest potential to be of benefit in this application. Further studies with hemodynamic models are required to properly assess the appropriateness in this setting. NA. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

Impact of Vial Capping on Residual Seal Force and Container Closure Integrity.

PubMed

Mathaes, Roman; Mahler, Hanns-Christian; Roggo, Yves; Ovadia, Robert; Lam, Philippe; Stauch, Oliver; Vogt, Martin; Roehl, Holger; Huwyler, Joerg; Mohl, Silke; Streubel, Alexander

2016-01-01

The vial capping process is a critical unit operation during drug product manufacturing, as it could possibly generate cosmetic defects or even affect container closure integrity. Yet there is significant variability in capping equipment and processes, and their relation to potential defects or container closure integrity has not been thoroughly studied. In this study we applied several methods-residual seal force tester, a self-developed system of a piezo force sensor measurement, and computed tomography-to characterize different container closure system combinations that had been sealed using different capping process parameter settings. Additionally, container closure integrity of these samples was measured using helium leakage (physical container closure integrity) and compared to characterization data. The different capping equipment settings lead to residual seal force values from 7 to 115 N. High residual seal force values were achieved with high capping pre-compression force and a short distance between the capping plate and plunge. The choice of container closure system influenced the obtained residual seal force values. The residual seal force tester and piezoelectric measurements showed similar trends. All vials passed physical container closure integrity testing, and no stopper rupture was seen with any of the settings applied, suggesting that container closure integrity was warranted for the studied container closure system with the chosen capping setting ranges. The vial capping process is a critical unit operation during drug product manufacturing, as it could possibly generate cosmetic defects or even affect container closure integrity. Yet there is significant variability in capping equipment and processes, and their relation to potential defects or container closure integrity has not been thoroughly studied. In this study we applied several methods-residual seal force tester, a self-developed system of a piezo force sensor measurement, and computed tomography-to characterize different container closure system combinations that had been sealed using different capping process parameter settings. The residual seal force tester can analyze a variety of different container closure systems independent of the capping equipment. An adequate and safe residual seal force range for each container closure system configuration can be established with the residual seal force tester and additional methods like computed tomography scans and leak testing. In the residual seal force range studied, the physical container closure integrity of the container closure system was warranted. © PDA, Inc. 2016.

An Infectious Pseudoaneurysm Caused by Ventricular Septal Defect Occluder in Patent Ductus Arteriosus Closure in a Two-Year-Old Child.

PubMed

Li, Dingyang; Qiu, Qiu; Jin, Jing; Zhang, Changdong; Wang, Lijun; Zhang, Gangcheng

2017-12-12

We present a case of an infectious pseudoaneurysm after patent ductus arteriosus (PDA) closure with a ventricular septal defect (VSD) occluder in a two-year-old child. The aneurysm grew rapidly but was successfully removed in time and the patient survived. To our knowledge, this is the first report of an infectious pseudoaneurysm caused by VSD occluder in PDA closure.

Platelets contribute to postnatal occlusion of the ductus arteriosus.

PubMed

Echtler, Katrin; Stark, Konstantin; Lorenz, Michael; Kerstan, Sandra; Walch, Axel; Jennen, Luise; Rudelius, Martina; Seidl, Stefan; Kremmer, Elisabeth; Emambokus, Nikla R; von Bruehl, Marie-Luise; Frampton, Jon; Isermann, Berend; Genzel-Boroviczény, Orsolya; Schreiber, Christian; Mehilli, Julinda; Kastrati, Adnan; Schwaiger, Markus; Shivdasani, Ramesh A; Massberg, Steffen

2010-01-01

The ductus arteriosus (DA) is a fetal shunt vessel between the pulmonary artery and the aorta that closes promptly after birth. Failure of postnatal DA closure is a major cause of morbidity and mortality particularly in preterm neonates. The events leading to DA closure are incompletely understood. Here we show that platelets have an essential role in DA closure. Using intravital microscopy of neonatal mice, we observed that platelets are recruited to the luminal aspect of the DA during closure. DA closure is impaired in neonates with malfunctioning platelet adhesion or aggregation or with defective platelet biogenesis. Defective DA closure resulted in a left-to-right shunt with increased pulmonary perfusion, pulmonary vascular remodeling and right ventricular hypertrophy. Our findings indicate that platelets are crucial for DA closure by promoting thrombotic sealing of the constricted DA and by supporting luminal remodeling. A retrospective clinical study revealed that thrombocytopenia is an independent predictor for failure of DA closure in preterm human newborns, indicating that platelets are likely to contribute to DA closure in humans.

Transcatheter closure of a small atrial septal defect with an Amplatzer™ patent foramen ovale occluder in a working dog with cyanosis and exercise intolerance at high altitude.

PubMed

Shelden, A; Wesselowski, S; Gordon, S G; Saunders, A B

2017-12-01

A 6.5-year-old male Border Collie presented for transcatheter closure of an atrial septal defect due to exercise intolerance and cyanosis while working and training at altitude. A small, left-to-right shunting secundum atrial septal defect was confirmed with no evidence of significant right-sided volume overload. Pulmonary hypertension with subsequent right-to-left interatrial shunting occurring during exercise at high altitude was suspected and prompted the closure of the defect due to the dog's continued athletic requirements. The anatomy of the defect prompted use of a patent foramen ovale occluder rather than an atrial septal defect occluder, which was deployed using a combination of fluoroscopic and transesophageal echocardiographic guidance. The owner did not report continued exercise intolerance or cyanosis and the dog's lifestyle and residence at altitude was unchanged. Copyright © 2017 Elsevier B.V. All rights reserved.

Intracardiac Echocardiography for Structural Heart and Electrophysiological Interventions.

PubMed

Basman, Craig; Parmar, Yuvrajsinh J; Kronzon, Itzhak

2017-09-06

With an increasing number of interventional procedures performed for structural heart disease and cardiac arrhythmias each year, echocardiographic guidance is necessary for safe and efficient results. The purpose of this review article is to overview the principles of intracardiac echocardiography (ICE) and describes the peri-interventional role of ICE in a variety of structural heart disease and electrophysiological interventions. Both transthoracic (TTE) and transesophageal echocardiography have limitations. ICE provides the advantage of imaging from within the heart, providing shorter image distances and higher resolution. ICE may be performed without sedation and avoids esophageal intubation as with transesophageal echocardiography (TEE). Limitations of ICE include the need for additional venous access with possibility of vascular complications, potentially higher costs, and a learning curve for new operators. Data supports the use of ICE in guiding device closure of interatrial shunts, transseptal puncture, and electrophysiologic procedures. This paper reviews the more recent reports that ICE may be used for primary guidance or as a supplement to TEE in patients undergoing left atrial appendage (LAA) closure, interatrial shunt closure, transaortic valve implantation (TAVI), percutaneous mitral valve repair (PMVR), paravalvular leak (PVL) closure, aortic interventions, transcatheter pulmonary valve replacement (tPVR), ventricular septal defect (VSD), and patent ductus arteriosus (PDA) closure. ICE imaging technology will continue to expand and help improve structural heart and electrophysiology interventions.

Direct Percutaneous Left Ventricular Access and Port Closure

PubMed Central

Barbash, Israel M.; Saikus, Christina E.; Faranesh, Anthony Z.; Ratnayaka, Kanishka; Kocaturk, Ozgur; Chen, Marcus Y.; Bell, Jamie A.; Virmani, Renu; Schenke, William H.; Hansen, Michael S.; Slack, Michael C.; Lederman, Robert J.

2012-01-01

Objectives This study sought to evaluate feasibility of nonsurgical transthoracic catheter-based left ventricular (LV) access and closure. Background Implanting large devices, such as mitral or aortic valve prostheses, into the heart requires surgical exposure and repair. Reliable percutaneous direct transthoracic LV access and closure would allow new nonsurgical therapeutic procedures. Methods Percutaneous direct LV access was performed in 19 swine using real-time magnetic resonance imaging (MRI) and an “active” MRI needle antenna to deliver an 18-F introducer sheath. The LV access ports were closed percutaneously using a commercial ventricular septal defect occluder and an “active” MRI delivery cable for enhanced visibility. We used “permissive pericardial tamponade” (temporary fluid instillation to separate the 2 pericardial layers) to avoid pericardial entrapment by the epicardial disk. Techniques were developed in 8 animals, and 11 more were followed up to 3 months by MRI and histopathology. Results Imaging guidance allowed 18-F sheath access and closure with appropriate positioning of the occluder inside the transmyocardial tunnel. Of the survival cohort, immediate hemostasis was achieved in 8 of 11 patients. Failure modes included pericardial entrapment by the epicardial occluder disk (n = 2) and a true-apex entry site that prevented hemostatic apposition of the endocardial disk (n = 1). Reactive pericardial effusion (192 ± 118 ml) accumulated 5 ± 1 days after the procedure, requiring 1-time drainage. At 3 months, LV function was preserved, and the device was endothelialized. Conclusions Direct percutaneous LV access and closure is feasible using real-time MRI. A commercial occluder achieved hemostasis without evident deleterious effects on the LV. Having established the concept, further clinical development of this approach appears realistic. PMID:22192372

Port closure techniques.

PubMed

Shaher, Z

2007-08-01

Laparoscopic trocars do create wounds. This article aims to review and list different techniques used for closure of the fascia incision at trocar sites. A literature search was performed for articles dealing with closure techniques. The author searched this subject in English on Medline by combining the words "trocar" and "hernia," as well as "Deschamps" and "Reverdin." All articles reporting techniques with their references were reviewed. The articles described many techniques in addition to classical closure using curved needles, including Grice needle, Maciol needles, Endoclose device, Carter-Thomason device, Tahoe ligature device, Endo-Judge device, eXit puncture closure device, Lowsley retractor, spinal cord needles, dual hemostat, suture carrier, Riverdin and Deschamps needles, and Gore-Tex closure device. Three main groups of techniques were found with favor of extracorporeal manipulations under direct visualization. Old methods are sufficient and cost-effective.

Three point-advancement closure for skin defects.

PubMed

Tamir, G; Birkby, C S; Berg, D

1999-10-01

Circular skin defects are common following Mohs' surgery. Traditional closure (primary, flap, or graft) may involve extensive surgery. Multidirectional advancement closures such as the purse-string closure have been advocated as another useful tool in such cases. To describe a variation on purse-string closure that, in certain cases, is an excellent alternative to other reconstructions, and will provide good cosmetic and functional outcome. A three-point anchoring suture is placed after undermining to advance the surrounding tissue toward the centre, creating a "Mercedes Benz" or tripod closure following removal of "dog-ears." Circular wounds in designated areas can be more easily closed, creating well-tolerated, favourable scars. Large wounds may be closed with the advantage of avoidance of larger flaps, of decreased wound healing compared to second intention, and of minimizing removal of healthy tissue. An initial trial of closure with this method does not limit subsequent use of other repairs should it be less than satisfactory.

[Clinical epidemiological study of neural tube defects classified according to the five sites of closure].

PubMed

Sanchis Calvo, A; Martínez- Frías, M

2001-02-01

To identify the frequency at birth of neural tube defects (NTD) in the Spanish population. NTDs were considered as a whole as well as according to the different sites of closure failure, following the theory of multisite closure of the neural tube. To analyze the epidemiological characteristics of the different sites. Data derived from the Spanish Collaborative Study of Congenital Malformations (ECEMC), from April 1976 to March 1995. Among the 1,222,698 live births during this period, 784 infants had NTD were controlled. Among these, 784 infants had NTD. The prevalence of NTD in our population was 1.01 per 1,000 births, a frequency which is considered medium-to low. Only 5.74% of the NTD were of known etiology: 2.17% were genic, 1.27% were chromosomic and 2.29% were environmental. Excluding NTD of genetic etiology, whether genic or chromosomic, most of the remaining were isolated defects (multifactorial) and 16.78% multiple malformations. Site 1, where the closure of the neural tube starts, represented 24% of all the affected sites. However, more than 50% of the NTDs corresponded to closure failure at the junction of two sites. As in other populations with a low prevalence of NTD at birth, the prevalence of these defects in our population showed a trend to decrease with time, due to the possibility of interrupting gestation after prenatal diagnosis. All the NTD could be classified according to the theory of multisite closure of the neural tube, including 13 cases with several noncontiguous affected sites. Two types of NTD were observed: in the first, closure failed to occur and in the second, two closures failed to meet.

Purse-string double-layer closure: a novel technique for repairing the uterine incision during cesarean section.

PubMed

Turan, Cem; Büyükbayrak, Esra Esim; Yilmaz, Aylin Onan; Karsidag, Yasemin Karageyim; Pirimoglu, Meltem

2015-04-01

To compare the classical double-layer uterine closure to a double-layer purse-string uterine closure (Turan technique) in cesarean section regarding short- and long-term results. Patients were randomized into either the double-layer purse-string uterine closure arm (study group, 84 patients) or the classical double-layer uterine closure arm (control group, 84 patients). For short-term comparison, a detailed transvaginal ultrasound examination was planned in all patients 6 weeks after the operation and a wedge-shaped defect in the uterine incision scar was accepted as uterine scar defect and recorded. For the long-term comparison, subsequent pregnancies of these patients were followed up for any complication. The number of patients with ultrasonographically visible uterine scar defect was 12 (23.5% of all scar defects) in the study group whereas it was 39 (76.5% of all scar defects) in the control group (P < 0.001, χ(2) = 15.42). Demographic data, operation time, hospitalization time, preoperative and postoperative hemoglobin values were not significantly different between the groups. During the 2-year of the follow-up period, five patients in the study group and six patients in the control group became pregnant again. No complication during their pregnancies and second cesarean operation were encountered. With the Turan technique, the uterine incision length becomes shorter, and the frequency of uterine scar defect is lower regarding short-term results. More data is needed for long-term results. ClinicalTrials.gov NCT01287611. © 2014 The Authors. Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology.

Percutaneous Steerable Robotic Tool Delivery Platform and Metal MEMS Device for Tissue Manipulation and Approximation: Closure of Patent Foramen Ovale in an Animal Model

PubMed Central

Vasilyev, Nikolay V.; Gosline, Andrew H.; Butler, Evan; Lang, Nora; Codd, Patrick J.; Yamauchi, Haruo; Feins, Eric N.; Folk, Chris R.; Cohen, Adam L.; Chen, Richard; Zurakowski, David; del Nido, Pedro J.; Dupont, Pierre E

2013-01-01

Background Beating-heart image-guided intracardiac interventions have been evolving rapidly. To extend the domain of catheter-based and transcardiac interventions into reconstructive surgery, a new robotic tool delivery platform (TDP) and tissue approximation device have been developed. Initial results employing these tools to perform patent foramen ovale (PFO) closure are described. Methods and Results A robotic TDP comprised of superelastic metal tubes provides the capability of delivering and manipulating tools and devices inside the beating heart. A new device technology is also presented that utilizes a metal-based MicroElectroMechanical Systems (MEMS) manufacturing process to produce fully-assembled and fully-functional millimeter-scale tools. As a demonstration of both technologies, a PFO creation and closure was performed in a swine model. In the first group of animals (N=10), a preliminary study was performed. The procedural technique was validated with a transcardiac handheld delivery platform and epicardial echocardiography, video-assisted cardioscopy and fluoroscopy. In the second group (N=9), the procedure was performed percutaneously using the robotic TDP under epicardial echocardiography and fluoroscopy imaging. All PFO’s were completely closed in the first group. In the second group, the PFO was not successfully created in 1 animal, and the defects were completely closed in 6 of the 8 remaining animals. Conclusions In contrast to existing robotic catheter technologies, the robotic TDP utilizes a combination of stiffness and active steerability along its length to provide the positioning accuracy and force application capability necessary for tissue manipulation. In combination with a MEMS tool technology, it can enable reconstructive procedures inside the beating heart. PMID:23899870

Percutaneous closure of hypertensive ductus arteriosus.

PubMed

Zabal, Carlos; García-Montes, José Antonio; Buendía-Hernández, Alfonso; Calderón-Colmenero, Juan; Patiño-Bahena, Emilia; Juanico-Enriquez, Antonio; Attie, Fause

2010-04-01

The Amplatzer duct occluder (ADO) has been used with success to close large patent ductus arteriosus (PDA), but some problems exist especially with hypertensive PDAs, such as incomplete closure, haemolysis, left pulmonary artery stenosis, obstruction of the descending aorta and progressive pulmonary vascular disease. We analysed a group of 168 patients with isolated PDA and pulmonary artery systolic pressure (PSAP) > or =50 mm Hg. Mean age was 10.3 +/- 14.3 years (median 3.9), PDA diameter was 6.4 +/- 2.9 mm (median 5.9), PASP was 63.5 +/- 16.2 mm Hg (median 60), Qp/Qs was 2.7 +/- 1.2 (median 2.5), total pulmonary resistance index (PRI) was 3.69 +/- 2.15 (median 3.35) and vascular PRI was 2.73 +/- 1.72 (median 2.37). We used ADOs in 145 (86.3%) cases, Amplatzer muscular ventricular septal defect occluders (AMVSDO) in 18 (10.7%), Amplatzer septal occluders (ASO) in three (1.8%) and the Gianturco-Grifka device in two (1.2%) cases. Device diameter was 106.3% +/- 51% higher than PDA diameter. PASP decreased after occlusion to 42.5 +/- 13.3 mm Hg (p<0.00001). Immediately after closure, no or trivial shunt was present in 123 (74.5%) cases. Immediate complications were device embolisation in five (3%) cases and descending aortic obstruction in one case. The overall success rate was 98.2%. Follow-up in 145 (86.3%) cases for 37.1 +/- 24 months (median 34.1) showed further decrease of the PASP to 30.1 +/- 7.7 mm Hg (p<0.0001). Percutaneous treatment of hypertensive PDA is safe and effective. ADO works well for most cases, but sometimes other devices (MVSDO or ASO) have to be used. When cases are selected adequately, pulmonary pressures decrease immediately and continue to fall with time.

The hyaloid vasculature facilitates basement membrane breakdown during choroid fissure closure in the zebrafish eye.

PubMed

James, Andrea; Lee, Chanjae; Williams, Andre M; Angileri, Krista; Lathrop, Kira L; Gross, Jeffrey M

2016-11-15

A critical aspect of vertebrate eye development is closure of the choroid fissure (CF). Defects in CF closure result in colobomas, which are a significant cause of childhood blindness worldwide. Despite the growing number of mutated loci associated with colobomas, we have a limited understanding of the cell biological underpinnings of CF closure. Here, we utilize the zebrafish embryo to identify key phases of CF closure and regulators of the process. Utilizing Laminin-111 as a marker for the basement membrane (BM) lining the CF, we determine the spatial and temporal patterns of BM breakdown in the CF, a prerequisite for CF closure. Similarly, utilizing a combination of in vivo time-lapse imaging, β-catenin immunohistochemistry and F-actin staining, we determine that tissue fusion, which serves to close the fissure, follows BM breakdown closely. Periocular mesenchyme (POM)-derived endothelial cells, which migrate through the CF to give rise to the hyaloid vasculature, possess distinct actin foci that correlate with regions of BM breakdown. Disruption of talin1, which encodes a regulator of the actin cytoskeleton, results in colobomas and these correlate with structural defects in the hyaloid vasculature and defects in BM breakdown. cloche mutants, which entirely lack a hyaloid vasculature, also possess defects in BM breakdown in the CF. Taken together, these data support a model in which the hyaloid vasculature and/or the POM-derived endothelial cells that give rise to the hyaloid vasculature contribute to BM breakdown during CF closure. Copyright © 2016 Elsevier Inc. All rights reserved.

[Early complications following transcatheter occlusion of perimembranous ventricular septal defects in children].

PubMed

Li, Jun-jie; Zhang, Zhi-wei; Qian, Ming-yang; Wang, Hui-shen; Li, Yu-fen

2006-11-01

To evaluate the early complications during and after transcatheter closure of perimembranous ventricular septal defects (PMVSDs) in children. A total of 223 patients received transcatheter closure of PMVSDs from March 2002 to December 2005 in our hospital were included in this retrospective study. The overall complications rate was 26.9% (60/223). Major complications occurred in 9 patients (4.0%) including III degrees atrioventricular block (AVB) in 2 (0.9%), hemolysis in 3 (1.3%) and surgical interventions in 4 patients (1.8%) because of device malposition (1), mild aortic regurgitation (2) and device embolization (1) and all 4 patients recovered without further complications. The 2 patients with III degrees AVB were completely recovered to normal sinus rhythm after 7 days treatment with temporary pacemaker and corticosteroid. Hemolysis in 3 patients disappeared after corticosteroid treatment. Minor complications occurred in 51 patients (22.8%) including bundle branch block (BBB) in 37 (16.6%), first-degree AVB in 2 (0.9%), second-degree AVB in 1 (0.4%), new-onset mild aortic regurgitation in 5 (2.2%) and new-onset mild to moderate tricuspid regurgitation in 6 patients (2.6%). Except for right bundle branch blocks, other BBBs were treated with albumin and corticosteroid and completely recovered. No treatment was applied for new-onset valve regurgitations. There was no death in all 223 patients. Early complications post PMVSDs in children are mostly minor with good prognosis and the prognosis for major complications post PMVSDs is good after proper treatment.

A case of residual inferior sinus venosus defect after ineffective surgical closure.

PubMed

Uga, Sayuri; Hidaka, Takayuki; Takasaki, Taiichi; Kihara, Yasuki

2014-10-03

A 38-year-old woman presented with cyanosis and heart failure 34 years after patch closure of an atrial septal defect and partial anomalous pulmonary venous connection. CT and cardiac catheterisation showed a residual defect that caused right-to-left shunting. The patch almost blocked the inferior vena cava from the right atrium, resulting in uncommon drainage of the inferior vena cava into the left atrium. Other anomalies included the coronary-to-pulmonary artery fistula and duplicate inferior vena cava with dilated azygos venous system. A second surgery was performed, and we confirmed an inferior sinus venosus defect, which is rare and can be misdiagnosed. The ineffective patch closure had caused a haemodynamic status that rarely occurs. We describe the diagnostic process and emphasise the importance of correctly understanding the entity. 2014 BMJ Publishing Group Ltd.

Pathobiology and genetics of neural tube defects.

PubMed

Finnell, Richard H; Gould, Amy; Spiegelstein, Ofer

2003-01-01

Neural tube defects (NTDs), including spina bifida and anencephaly, are common congenital malformations that occur when the neural tube fails to achieve proper closure during early embryogenesis. Based on epidemiological and clinical data obtained over the last few decades, it is apparent that these multifactorial defects have a significant genetic component to their etiology that interacts with specific environmental risk factors. The purpose of this review article is to synthesize the existing literature on the genetic factors contributing to NTD risk. To date, there is evidence that closure of the mammalian neural tube initiates and fuses intermittently at four discrete locations. Disruption of this process at any of these four sites may lead to an NTD, possibly arising through closure site-specific genetic mechanisms. Candidate genes involved in neural tube closure include genes of the folate metabolic pathway, as well as those involved in folate transport. Although extensive efforts have focused on elucidating the genetic risk factors contributing to the etiology of NTDs, the population burden for these malformations remains unknown. One group at high risk for having children with NTDs is epileptic women receiving antiepileptic medications during pregnancy. Efforts to better understand the genetic factors that may contribute to their heightened risk, as well as the pathogenesis of neural tube closure defects, are reviewed herein.

Comparison of techniques for transdiaphragmatic thoracic drainage after diaphragmatic defect closure in dogs: a cadaveric study

PubMed Central

Yoon, Hun-Young; Mann, F. A.; Lee, Suhwon

2013-01-01

Four thoracic evacuation techniques for pneumothorax elimination after diaphragmatic defect closure were compared in 40 canine cadavers. After creating a defect in the left side of the diaphragm, thoracic drainage was performed by thoracostomy tube insertion through the defect and a small (DD-SP) or large (DD-LP) puncture created in the caudal mediastinum, or through both the diaphragmatic defect and intact contralateral diaphragm with a small (DI-SP) or large (DI-LP) puncture in made in the caudal mediastinum. Differences in intrapleural pressure (IPP) between the right and left hemithoraxes after air evacuation along with differences in IPP before making a defect and after air evacuation in each hemithorax were calculated. A difference (p ≤ 0.0011) in IPP between the left and right hemithoraxes after air evacuation as well as before making a defect and after air evacuation in the right hemithorax was detected for the DD-SP group. No significant differences (p ≥ 0.0835) were observed for the DI-LP, DD-LP, or DI-SP groups. Creation of a large mediastinal puncture or thoracic evacuation through both a diaphragmatic defect and intact contralateral diaphragm can facilitate proper pneumothorax elimination bilaterally after diaphragmatic defect closure in dogs with a small puncture in the caudal mediastinum. PMID:23814472

Dural closure for the treatment of superficial siderosis.

PubMed

Egawa, Satoru; Yoshii, Toshitaka; Sakaki, Kyohei; Inose, Hiroyuki; Kato, Tsuyoshi; Kawabata, Shigenori; Tomizawa, Shoji; Okawa, Atsushi

2013-04-01

Superficial siderosis (SS) of the CNS is a rare disease caused by repeated hemorrhages in the subarachnoid space. The subsequent deposition of hemosiderin in the brain and spinal cord leads to the progression of neurological deficits. The causes of bleeding include prior intradural surgery, carcinoma, arteriovenous malformation, nerve root avulsion, and dural abnormality. Recently, surgical treatment of SS associated with dural defect has been reported. The authors of the present report describe 2 surgically treated SS cases and review the literature on surgically treated SS. The patients had dural defects with fluid-filled collections in the spinal canal. In both cases, the dural defects were successfully closed, and the fluid collection was resolved postoperatively. In one case, the neurological symptoms did not progress postoperatively. In the other case, the patient had long history of SS, and the clinical manifestations partially deteriorated after surgery, despite the successful dural closure. In previously reported surgically treated cases, the dural defects were closed by sutures, patches, fibrin glue, or muscle/fat grafting. Regardless of the closing method, dural defect closure has been shown to stop CSF leakage and subarachnoid hemorrhaging. Successfully repairing the defect can halt the disease progression in most cases and may improve the symptoms that are associated with CSF hypovolemia. However, the effect of the dural closure may be limited in patients with long histories of SS because of the irreversibility of the neural tissue damage caused by hemosiderin deposition. In patients with SS, it is important to diagnose and repair the dural defect early to minimize the neurological impairments that are associated with dural defects.

Comparison of cost-effectiveness and postoperative outcome of device closure and open surgery closure techniques for treatment of patent ductus arteriosus.

PubMed

Ahmadi, Alireza; Sabri, Mohammadreza; Bigdelian, Hamid; Dehghan, Bahar; Gharipour, Mojgan

2014-01-01

Various devices have been recently employed for percutaneous closure of the patent ductus arteriosus (PDA). Although the high effectiveness of device closure techniques has been clearly determined, a few studies have focused on the cost-effectiveness and also postoperative complications of these procedures in comparison with open surgery. The present study aimed to evaluate the clinical outcome and cost-effectiveness of PDA occlusion by Amplatzer and coil device in comparisong with open surgery. In this cross-sectional study, a randomized sample of 201 patients aged 1 month to 16 years (105 patients with device closure and 96 patients with surgical closure) was selected. The ratio of total pulmonary blood flow to total systemic blood flow, the Qp/Qs ratio, was measured using a pulmonary artery catheter. The cost analysis included direct medical care costs associated with device implantation and open surgery, as well as professional fees. All costs were calculated in Iranian Rials and then converted to US dollars. There was no statistical difference in mean Qp/Qs ratio before the procedure between the device closure group and the open surgery group (2.1 ± 0.7 versus 1.7 ± 0.6, P = 0.090). The mean measured costs were overall higher in the device closure group than in open closure group (948.87 ± 548.76 US$ versus 743.70 ± 696.91 US$, P < 0.001). This difference remained significant after adjustment for age and gender (Standardized Beta = 0.160, P = 0.031). PDA closure with the Amplatzer ductal occluder (1053.05 ± 525.73 US$) or with Nit-Occlud coils (PFM) (912.73 ± 565.94 US$, P < 0.001) was more expensive than that via open surgery. However, the Cook detachable spring coils device closure (605.65 ± 194.62 US$, P = 0.650) had a non-significant cost difference with open surgery. No event was observed in the device closure group regarding in-hospital mortality or morbidity; however, in another group, 2 in-hospital deaths occurred, two patients experienced pneumonia and seizure, and one suffered electrolyte abnormalities including hyponatremia and hypocalcemia. Although open surgery seems to be less expensive than device closure technique, because of lower mortality and morbidity, the latter group is more preferable.

The receptor tyrosine kinase Pvr promotes tissue closure by coordinating corpse removal and epidermal zippering

PubMed Central

Garlena, Rebecca A.; Lennox, Ashley L.; Baker, Lewis R.; Parsons, Trish E.; Weinberg, Seth M.; Stronach, Beth E.

2015-01-01

A leading cause of human birth defects is the incomplete fusion of tissues, often manifested in the palate, heart or neural tube. To investigate the molecular control of tissue fusion, embryonic dorsal closure and pupal thorax closure in Drosophila are useful experimental models. We find that Pvr mutants have defects in dorsal midline closure with incomplete amnioserosa internalization and epidermal zippering, as well as cardia bifida. These defects are relatively mild in comparison to those seen with other signaling mutants, such as in the JNK pathway, and we demonstrate that JNK signaling is not perturbed by altering Pvr receptor tyrosine kinase activity. Rather, modulation of Pvr levels in the ectoderm has an impact on PIP3 membrane accumulation, consistent with a link to PI3K signal transduction. Polarized PI3K activity influences protrusive activity from the epidermal leading edge and the protrusion area changes in accord with Pvr signaling intensity, providing a possible mechanism to explain Pvr mutant phenotypes. Tissue-specific rescue experiments indicate a partial requirement in epithelial tissue, but confirm the essential role of Pvr in hemocytes for embryonic survival. Taken together, we argue that inefficient removal of the internalizing amnioserosa tissue by mutant hemocytes coupled with impaired midline zippering of mutant epithelium creates a situation in some embryos whereby dorsal midline closure is incomplete. Based on these observations, we suggest that efferocytosis (corpse clearance) could contribute to proper tissue closure and thus might underlie some congenital birth defects. PMID:26293306

The influence of deficient retro-aortic rim on technical success and early adverse events following device closure of secundum atrial septal defects: An Analysis of the IMPACT Registry®.

PubMed

O'Byrne, Michael L; Gillespie, Matthew J; Kennedy, Kevin F; Dori, Yoav; Rome, Jonathan J; Glatz, Andrew C

2017-01-01

Concern regarding aortic erosion has focused attention on the retro-aortic rim in patients undergoing device closure of atrial septal defects (ASD), but its effect on early outcomes is not well studied. A multicenter retrospective cohort study of patients undergoing device occlusion of ASD between 1/2011-10/2014 was performed, using data from the IMproving Pediatric and Adult Congenital Treatment Registry. Subjects were divided between those with retro-aortic rim <5 and ≥5 mm. Primary outcomes were technical failure and major early adverse events. Case times were measured as surrogates of technical complexity. The effect of deficient retro-aortic rim on primary outcomes was assessed using hierarchical logistic regression, adjusting for other suspected covariates and assessing whether they represent independent risk factors RESULTS: 1,564 subjects (from 77 centers) were included, with deficient retro-aortic rim present in 40%. Technical failure occurred in 91 subjects (5.8%) and a major early adverse event in 64 subjects (4.1%). Adjusting for known covariates, the presence of a deficient retro-aortic rim was not significantly associated with technical failure (OR: 1.3, 95% CI: 0.9-2.1) or major early adverse event (OR: 0.7, 95% CI: 0.4-1. 2). Total case (P = 0.01) and fluoroscopy time (P = 0.02) were greater in subjects with deficient rim, but sheath time was not significantly different (P = 0.07). Additional covariates independently associated with these outcomes were identified. Deficient retro-aortic rim was highly prevalent but not associated with increased risk of technical failure or early adverse events. Studies with longer follow-up are necessary to assess other outcomes, including device erosion. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Scalp Wound Closure with K wires: An alternative easier method to scalp wound closure.

PubMed

Ramesh, S; Ajik, S

2012-12-01

Scalp defects and lacerations present a reconstructive challenge to plastic surgeons. Many methods have been described from the use of skin grafting to rotation flaps. Here we present a method of closure of a contaminated scalp wound with the use of Kirschner wires. In our case, closure of scalp laceration was made possible with the use of 1.4 Kirschner wires and cable tie/ zip tie fasteners. The duration to closure of wound was 10 days. In reconstructing the scalp defect, this method was found to adhere to principles of scalp reconstruction. There were no post operative complications found from the procedure. On initial application on the edge of the wound, tension applied caused the K wires to cut through the wound edge. On replacement of K wires 1cm away from wound edge the procedure was not plagued by any further complication. In conclusion we find scalp closure with Kirschner wires are a simple and effective method for scalp wound closure.

Arrhythmias in Patients with Atrial Defects.

PubMed

Contractor, Tahmeed; Mandapati, Ravi

2017-06-01

Atrial arrhythmias are common in patients with atrial septal defects. A myriad of factors are responsible for these that include remodeling related to the defect and scar created by the repair or closure. An understanding of potential arrhythmias, along with entrainment and high-density activation mapping can result in accurate diagnosis and successful ablation. Atrial fibrillation is being seen increasingly after patent foramen ovale closure and may be the primary etiology of recurrent stroke in these patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Interventional Cardiology: What's New?

PubMed

Scansen, Brian A

2017-09-01

Interventional cardiology in veterinary medicine continues to expand beyond the standard 3 procedures of patent ductus arteriosus occlusion, balloon pulmonary valvuloplasty, and transvenous pacing. Opportunities for fellowship training; advances in equipment, including high-resolution digital fluoroscopy, real-time 3-dimensional transesophageal echocardiography, fusion imaging, and rotational angiography; ultrasound-guided access and vascular closure devices; and refinement of techniques, including cutting and high-pressure ballooning, intracardiac and intravascular stent implantation, septal defect occlusion, transcatheter valve implantation, and hybrid approaches, are likely to transform the field over the next decade. Copyright © 2017 Elsevier Inc. All rights reserved.

Comparison of V-Loc™ 180 wound closure device and Quill™ PDO knotless tissue-closure device for intradermal closure in a porcine in vivo model: evaluation of biomechanical wound strength.

PubMed

Gingras, Kristen; Zaruby, Jeffrey; Maul, Don

2012-05-01

The objective of this study was to compare the biomechanical strength of two barbed suture devices: V-Loc™ 180 Wound Closure Device and Quill™ PDO Knotless Tissue-Closure Device following primary cosmetic skin closures in a porcine dermal model. This prospective randomized, controlled in vivo trial compared size 3/0 V-Loc™ 180 device to size 2/0 Quill™ PDO device. Both products were tested for dermal closure in adult porcine models and evaluated at five timepoints. At postoperative days 0, 3, 7, 14, and 28 sutured tissue regions were excised post mortem and tested for intradermal wound holding strength. Wounds closed with V-Loc™ 180 device were stronger than Quill™ PDO device at days 0, 3, 7, and 14 with these differences being significant (p < 0.05) at days 3 and 7. At day 3, the average maximum load of V-Loc™ 180 was 13.53 kgf and Quill™ PDO was 10.38 kgf (p = 0.002). At day 7, the average maximum load of V-Loc™ 180 was 10.4 kgf and Quill™ PDO was 7.56 kgf (p = 0.001). Throughout the duration of the study, there was no suture extrusion or tissue distortion and all wounds healed with no major complications. In this study, V-Loc™ 180 device was significantly stronger than Quill™ PDO device during the critical phases of wound healing in skin. Copyright © 2012 Wiley Periodicals, Inc.

Percutaneous device closure of patent ductus arteriosus with pulmonary artery hypertension: long-term results.

PubMed

Vijayalakshmi, Ishwarappa Balekundri; Setty, Natraj; Narasimhan, Chitra; Singla, Vivek; Manjunath, Cholenahalli Nanjappa

2014-12-01

Device closure of patent ductus arteriosus (PDA) is treatment of choice. But device closure in presence of pulmonary artery hypertension (PAH) remains a challenge. Data on patient selection, technical considerations, and complications are limited. To know the challenges and efficacy of device closure of PDA with PAH. Out of 1,325 cases of device closure of PDA, 246 (18.6%) with PAH formed the study material. To test the feasibility, chosen device is used to occlude PDA for ten minutes without oxygen inhalation. The device is released only if PAH reduced. PAH decreased in all except in 1 patient after closure with muscular ventricular septal occluder (MVSDO), pulmonary artery pressure (PAP) transiently increased (became supra-systemic), without significant reduction in aortic pressure. Device embolized in 8 patients (3.3%). Percutaneous retrieval was done in 4 (by snare in 2 and by fixing the cable to device in 2) and replaced with bigger devices. The surgical removal of the embolized MVSDO and ligation was done in 4 cases. All patients were on oral sildenafil and bosentan until PAP regressed to normal. Follow up was from 6 months to 9 years. No residual shunt in any patient on follow-up. The PAP regressed to normal in all except 5 cases (2.03%) of Down's syndrome with systemic PAP. Device closure of PDA with PAH is feasible, safe in all age groups. Temporary PDA occlusion with device is effective and time saving for evaluating pulmonary vascular reactivity. Device embolization in aorta is higher with severe PAH. Novel method of retrieval is effective. © 2014, Wiley Periodicals, Inc.

Percutaneous closure of a hemodynamically significant connection between the inferior vena cava and the left atrium.

PubMed

Wiebe, Jens; Rixe, Johannes; Nef, Holger

2015-10-01

A connection between the inferior vena cava (IVC) and the left atrium (LA) can occur as a rare complication after surgical atrial septum defect (ASD) repair. We demonstrate the first case of a percutaneous closure of this connection. A 67-year-old female was admitted to hospital due to exertional dyspnea. A history of a surgical ASD repair in 1960 and 1966 with a residual shunt was already known. Transesophageal echocardiography and a CT scan revealed a hemodynamically significant drainage of the IVC into the LA. This connection was successfully closed percutaneously with an AMPLATEZR Duct Occluder I (St. Jude Medical, St. Paul, MN). Post-procedural CT-scan and transthoracic echocardiography demonstrated a stable position and there was also no evidence of a residual shunt. The patient reported a significant reduction of exertional dyspnea. Percutaneous closure of an IVC to LA connection in this case was safe and feasible. The decision about which device is optimal must be made on an individual basis. © 2015 Wiley Periodicals, Inc.

A Practical Scoring System to Select Optimally Sized Devices for Percutaneous Patent Foramen Ovale Closure.

PubMed

Venturini, Joseph M; Retzer, Elizabeth M; Estrada, J Raider; Mediratta, Anuj; Friant, Janet; Nathan, Sandeep; Paul, Jonathan D; Blair, John; Lang, Roberto M; Shah, Atman P

2016-10-01

Patent foramen ovale (PFO) has been linked to cryptogenic stroke, and closure has been reported to improve clinical outcomes. However, there are no clear guidelines to direct device sizing. This study sought to use patient characteristics and echocardiographic findings to create a prediction score for device sizing. This was a retrospective review of patients undergoing percutaneous PFO closure at our institution between July 2010 and December 2014. Demographic and clinical characteristics were recorded, and all pre- and intraprocedural echocardiography results were evaluated. Thirty-six patients underwent percutaneous PFO closure during the study period. All procedures were performed using an Amplatzer Septal Occluder "Cribriform" (ASOC) device in one of three disc diameters: 25, 30, or 35 mm. Closure was indicated for cryptogenic stroke/transient ischemic attack in 75% of cases. Every case (100%) was successful with durable shunt correction at the 6-month follow-up without complications of erosion or device embolization. The presence of atrial septal aneurysm (ASA) ( p = 0.027) and PFO tunnel length >10 mm ( p = 0.038) were independently associated with increased device size. A scoring system of 1 point for male sex, 1 point for ASA, and 1 point for PFO tunnel >10 mm long was associated with the size of closure device implanted ( p = 0.006). A simple scoring system may be used to select an optimally sized device for percutaneous PFO closure using the ASOC device.

Cardi-O-Fix duct occluder versus Amplatzer duct occluder for closure of patent ductus arteriosus.

PubMed

Celebi, Ahmet; Demir, Ibrahim Halil; Saritaş, Türkay; Dedeoğlu, Reyhan; Yucel, Ilker Kemal; Demir, Fadli; Erdem, Abdullah

2013-11-15

We sought to investigate the safety, efficacy, and follow-up results of percutaneous patent ductus arteriosus (PDA) closure using the novel Cardi-O-Fix duct occluder (CDO), a device similar to but less expensive than the Amplatzer duct occluder (ADO). We also aimed to compare these two devices in terms of results. Between March 2005 and May 2012, 167 patients diagnosed with moderate-to-large PDA underwent transcatheter closure. ADO was used in 56 (33.5%) patients with a mean age of 8.1 ± 11.9 years (3.6 months-56 years), whereas CDO was used in 111 (66.5%) patients with a mean age of 12.6 ± 14.6 years (4.8 months-63 years). The narrowest PDA diameter, the used device diameter, procedure time, fluoroscopy time, and residual shunt rates were similar between the two groups. Procedural success rate was 100% in both groups. Although the residual shunt rate was higher in the CDO group immediately after the procedure, the difference was not statistically significant (12.6 vs. 8.9%; P = 0.3). There was no statistically significant difference between groups at discharge and during follow-up. No deaths occurred in any of the groups, and there were no differences in complication rates during the short- and mid-term follow-up periods (CDO 7/111 vs. ADO 5/56; P = 0.5 π). The CDO can be used for PDA closure because of its safety, effectiveness, and simplicity in use. It is available in bigger sizes and can be used in patients with large defects. According to our short- and mid-term findings, the results it yields are similar to those of the ADO; thus, it may be the preferred choice owing to its low cost and large size variability. Copyright © 2013 Wiley Periodicals, Inc.

40 CFR 63.946 - Inspection and monitoring requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... its foundation mountings; broken, cracked, or otherwise damaged seals or gaskets on closure devices; and broken or missing hatches, access covers, caps, or other closure devices. (2) The owner or...; broken, cracked, or otherwise damaged seals or gaskets on closure devices; and broken or missing hatches...

Recent development of transcatheter closure of atrial septal defect and patent foramen ovale with occluders.

PubMed

Tang, Baiyu; Su, Feng; Sun, Xiangke; Wu, Qin; Xing, Quansheng; Li, Suming

2018-01-01

Atrial septal defect (ASD) and patent foramen ovale (PFO) are common clinical congenital heart defects. As an effective method for the treatment of ASD and PFO, transcatheter closure with occluders presents many advantages, including safety, ease of operation, minimal invasiveness, and reduced complications. This contribution reviews the various types of occluders currently used in clinical applications and under development, including non degradable occluders, partially degradable occluders, and totally degradable occluders. A number of case studies are described in detail. Comparison is made on the treatment outcomes using different occulders. Future development of transcatheter closure is discussed, in particular the use of totally degradable occluders. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 433-443, 2018. © 2016 Wiley Periodicals, Inc.

[The cutaneous groin flap for coverage of a full-thickness abdominal wall defect].

PubMed

Doebler, O; Spierer, R

2010-08-01

A full-thickness defect of the abdominal wall is rare and may occur as a complication of extended abdominal surgery procedures. We report about a 69-year-old patient who was presented to our department with a full-thickness abdominal wall defect and a fully exposed collagen-mesh for reconstructive wound closure. 13 operations with resections of necrotic parts of the abdominal wall were performed following a complicated intraabdominal infection. After debridement and mesh explantation, closure of the remaining defect of the lower abdominal region was achieved by a cutaneous groin flap. Georg Thieme Verlag KG Stuttgart New York.

Simultaneous transcatheter closure of intralobar pulmonary sequestration and patent ductus arteriosus in a patient with infantile Scimitar syndrome.

PubMed

Aslan, Eyüp; Tanıdır, İbrahim Cansaran; Saygı, Murat; Onan, Sertaç Hanedan; Güzeltaş, Alper

2015-03-01

Scimitar syndrome is a rare disease associated with a right lung sequestration vascularised by arteries arising from the abdominal aorta and abnormal venous drainage into the inferior vena cava. The infantile form is generally presented with severe heart failure, pulmonary hypertension and respiratory distress. It may be associated with various intracardiac defects, including atrial septal defects, ventricular septal defects, patent ductus arteriosus or more complicated structural congenital heart defects. Here, we present a 2-month-old girl with Scimitar syndrome whose pulmonary arterial pressure decreased after transcatheter patent ductus arteriosus closure and embolization of the anomalous systemic arterial supply.

[Percutaneous closure of ductus arteriosus and muscular ventricular defect with amplatzer occluder in a patient with severe pulmonary hypertension].

PubMed

García-Montes, José Antonio; Zabal Cerdeira, Carlos; Calderón-Colmenero, Juan; Espínola, Nilda; Fernández de la Reguera, Guillermo; Buendía Hernández, Alfonso

2005-01-01

Surgical treatment of multiple muscular ventricular septal defects with associated lesions and severe pulmonary hypertension has a high morbility and mortality. Closure of these defects by the Amplatzer muscular VSD occluder is an alternative to surgery, avoiding the need of cardiopulmonary bypass. We present the case of a 38 year-old woman with signs of heart failure in NYHA functional class IV, with two muscular ventricular septal defects, patent ductus arteriosus and severe pulmonary hypertension, that were treated with three Amplatzer muscular VSD occluders, with significant reduction of pulmonary pressure and functional class improvement.

40 CFR 63.1047 - Inspection and monitoring requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... separator wall; broken, cracked, or otherwise damaged seals or gaskets on closure devices; and broken or... the surface of the liquid in the separator; broken, cracked, or otherwise damaged seals or gaskets on closure devices; and broken or missing hatches, access covers, caps, or other closure devices. (ii) The...

Results of comparing transthoracic device closure and surgical repair with right infra-axillary thoracotomy for perimembranous ventricular septal defects.

PubMed

Hu, Yijie; Li, Zhiping; Chen, Jianming; Li, Fuping; Shen, Cheng; Song, Yi; Zhao, Shulin; Peng, Caijing; Chen, Mingxiang; Zhong, Qianjin

2015-04-01

Transthoracic device closure (TTDC) and surgical repair with right infra-axillary thoracotomy (SRRIAT) are two main alternative minimally invasive approaches for restrictive perimembranous ventricular septal defect (VSD); however, few studies have compared them with each other in terms of effectiveness and cost. Patients with perimembranous VSD undergoing TTDC or SRRIAT from January 2012 to July 2013 were reviewed in a comparative investigation between the two procedures. Success from the procedures was achieved in 30 TTDC (30/33, 91%) and 96 SRRIAT patients (100%). Operation duration in the TTDC group was significantly shorter than that of the SRRIAT group (115.8 ± 43.8 vs 175.6 ± 41.3 min, P < 0.01). The total perioperative drainage, use of red blood cells, mechanical ventilation time, stay in the intensive care unit and hospital stay for the TTDC group were significantly less than those in the SRRIAT group. No deaths or complete atrioventricular block occurred in either group. One SRRIAT patient accepted a second surgery for residual shunt. TTDC costs slightly more than SRRIAT (40270.6 ± 2741.3 renmingbi [RMB] vs 32964.5 ± 8221.6 RMB, P < 0.01). Both TTDC and SRRIAT showed excellent outcomes and cosmetic appearance for suitable VSD candidates. Although its costs were higher, TTDC had the advantages over SRRIAT of a short operation duration and intensive care unit stay and fewer days in the hospital. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Computational Modeling and Simulation of Genital Tubercle ...

EPA Pesticide Factsheets

Hypospadias is a developmental defect of urethral tube closure that has a complex etiology. Here, we describe a multicellular agent-based model of genital tubercle development that simulates urethrogenesis from the urethral plate stage to urethral tube closure in differentiating male embryos. The model, constructed in CompuCell3D, implemented spatially dynamic signals from SHH, FGF10, and androgen signaling pathways. These signals modulated stochastic cell behaviors, such as differential adhesion, cell motility, proliferation, and apoptosis. Urethral tube closure was an emergent property of the model that was quantitatively dependent on SHH and FGF10 induced effects on mesenchymal proliferation and endodermal apoptosis, ultimately linked to androgen signaling. In the absence of androgenization, simulated genital tubercle development defaulted to the female condition. Intermediate phenotypes associated with partial androgen deficiency resulted in incomplete closure. Using this computer model, complex relationships between urethral tube closure defects and disruption of underlying signaling pathways could be probed theoretically in multiplex disturbance scenarios and modeled into probabilistic predictions for individual risk for hypospadias and potentially other developmental defects of the male genital tubercle. We identify the minimal molecular network that determines the outcome of male genital tubercle development in mice.

Percutaneous Closure of 2 Paravalvular Leaks and a Gerbode Defect after Mitral Valve Replacement for Infective Endocarditis.

PubMed

Peñalver, Jorge; Shatila, Wassim; Silva, Guilherme V

2017-04-01

Surgical valve replacement after infective endocarditis can result in local destructive paravalvular lesions. A 30-year-old woman with infective endocarditis underwent mitral valve replacement that was complicated postoperatively by 2 paravalvular leaks. During percutaneous closure of the leaks, a Gerbode defect was also found and closed. We discuss our patient's case and its relation to others in the relevant medical literature. To our knowledge, we are the first to describe the use of a percutaneous approach to close concomitant paravalvular leaks and a Gerbode defect.

Closure of large patent ductus arteriosus using the Amplatzer Septal Occluder.

PubMed

García-Montes, José A; Camacho-Castro, Anahí; Sandoval-Jones, Juan P; Buendía-Hernández, Alfonso; Calderón-Colmenero, Juan; Patiño-Bahena, Emilia; Zabal, Carlos

2015-03-01

Percutaneous closure of patent ductus arteriosus has become the treatment of choice in many centres. In patients with large ducts and pulmonary hypertension, transcatheter closure has been achieved with success using the Amplatzer Duct Occluder or even the Amplatzer Muscular Ventricular Septal Defect Occluder. We present a series of 17 patients with large and hypertensive ductus arteriosus who were treated with an Amplatzer Septal Occluder. The group had 11 female patients (64.7%) and a mean age of 18.6±12.1 years. The haemodynamic and anatomical data are as follows: pulmonary artery systolic pressure 71.3±31.8 mmHg, pulmonary to systemic flow ratio 3.14±1.36, ductal diameter at the pulmonary end 12.5±3.8 mm, and at the aortic end 20.2±7.7 mm; 14 cases (82.3%) had type A ducts. In 11 patients, we began the procedure using a different device - six with duct occluder and five with ventricular septal occluder - and it was changed because of device embolisation in six (35.3%). All septal occluders were delivered successfully. Residual shunt was moderate in six patients (35.3%), mild in eight (47%), trivial in two (11.8%), and no shunt in one (5.9%). Pulmonary systolic pressure decreased to 48.9±10.8 mmHg after occlusion (p=0.0015). Follow-up in 15 patients (88.2%) for 28.4±14.4 months showed complete closure in all cases but one, and continuous decrease of the pulmonary systolic pressure to 31.4±10.5 mmHg. No complications at follow-up have been reported. The Amplatzer Septal Occluder is a good alternative to percutaneously treat large and hypertensive ductus arteriosus.

Anatomy of the patent foramen ovale for the interventionalist.

PubMed

McKenzie, Jeff A; Edwards, William D; Hagler, Donald J

2009-05-01

Patent foramen ovale (PFO) is an interatrial communication whose management is controversial. Several manufacturers have submitted protocols for Food and Drug Administration (FDA) approval of their PFO closure device. The purpose of this study was to define anatomy relevant to percutaneous PFO closure, validate the clinical observation that most PFOs contain little tissue rim at the aorta, comment on proposed closure guidelines, and to discuss approaches to PFO closure. From the Mayo Clinic Tissue Registry, five normal hearts with PFO were selected from each sex from the first 10 decades of life (n = 100). Measurements (mm) included PFO length, diameter, and distance from FO-superior vena cava (SVC) and FO-aortic annulus (AoAn). Patient age, weight, and height were obtained from autopsy reports, and body surface area (BSA) was calculated. PFO length and diameter increased with age (P = 0.029 and 0.001, respectively), and FO-SVC and FO-AoAn increased with BSA (P

Directly ventricular septal defect closure without using arteriovenous wire loop: Our adult case series using transarterial retrograde approach

PubMed Central

Pekel, Nihat; Ercan, Ertuğrul; Özpelit, Mehmet Emre; Özyurtlu, Ferhat; Yılmaz, Akar; Topaloğlu, Caner; Saygı, Serkan; Yakan, Serkan; Tengiz, İstemihan

2017-01-01

Objective: The standard transcatheter ventricular septal defects (VSD) closure procedure is established with arteriovenous (AV) loop and is called as antegrade approach. The directly retrograde transarterial VSD closure without using AV loop might be better option as shortens the procedure time and decreases radiation exposure. Methods: Our series consist of twelve sequential adult cases with congenital VSDs (seven with perimembranous, four with muscular, one with postoperative residuel VSD). The mean age was 26.9 (Range 18–58), the mean height was 168.75 cm (Range 155–185cm), and the mean body mass index was 23.4 (Range 17.3–28.4). Maximum and minimum defect sizes were 10 and 5 mm and the mean defect size was 6.24 mm. The procedure was performed with left heart catheterization and advancing the delivery sheath over the stiff exchange wire then VSD occlusion from left side. Results: The defects were successfully closed with this technique in eleven patients. In sixth patient, the defect could not be cannulated by the delivery sheath, as the tip of the sheath did not reach the defect and VSD was closed with same sheath by standard transvenous approach using AV loop. We didn’t encounter any complication releated to semilunar or atrioventricular valves. Atrioventricular conduction system was not affected by the procedure in any patients. The median procedure and fluoroscopy times were 66 and 16.5 minutes respectively. Conclusion: Transarterial retrograde VSD closure without using AV loop simplifies the procedure, decreases the radiation exposure, and shortens the procedure time. The only limitation in adult patients is delivery sheath length. PMID:28315566

Short-term safety and efficacy of left atrial appendage closure with the WATCHMAN device in patients with small left atrial appendage ostia.

PubMed

Venkataraman, Ganesh; Strickberger, S Adam; Doshi, Shephal; Ellis, Christopher R; Lakkireddy, Dhanunjaya; Whalen, S Patrick; Cuoco, Frank

2018-01-01

Left atrial appendage (LAA) closure with the WATCHMAN device, according to FDA labelling, is recommended in patients with a maximal LAA ostial width between 17 and 31 mm. The safety and efficacy of LAA closure in patients with a maximal LAA ostial width < 17 mm has not been evaluated. The goal of this study was to determine the acute and short-term safety and efficacy of LAA closure with the WATCHMAN device in patients with a maximal LAA ostial width < 17 mm. Thirty-two consecutive patients with a maximal LAA ostial width < 17 mm as determined by a screening transesophageal echocardiogram (TEE) underwent LAA closure with the WATCHMAN device between March 2015 and November 2016 at five medical centers, and were included in this study. Mean age, body mass index (BMI), and CHA 2 DS 2 -VASC score were 70.8 ± 8.6 years, 29.3 ± 6.5 kg/m 2 , and 3.9 ±1.2, respectively. At the screening TEE, mean maximal LAA ostial width and depth were 15.6 ± 0.6 mm (range 14-16) and 23.2 ± 4.5 mm (range 13-31), respectively. Successful LAA closure with the WATCHMAN device was achieved in 31 of 32 patients (97%), with no major complications. TEE performed 45 days after LAA closure demonstrated no peridevice leak > 5 mm and no device related thrombi. Warfarin was discontinued in all 31 patients 45 days after LAA closure. LAA closure with the WATCHMAN device can be successfully and safely achieved in patients with a maximal LAA ostial width < 17 mm. © 2017 Wiley Periodicals, Inc.

Echocardiographic predictors of coil vs device closure in patients undergoing percutaneous patent ductus arteriosus closure.

PubMed

Roushdy, Alaa; Abd El Razek, Yasmeen; Mamdouh Tawfik, Ahmed

2018-01-01

To determine anatomic and hemodynamic echocardiographic predictors for patent ductus arteriosus (PDA) device vs coil closure. Seventy-six patients who were referred for elective transcatheter PDA closure were enrolled in the study. All patients underwent full echocardiogram including measurement of the PDA pulmonary end diameter, color flow width and extent, peak and end-diastolic Doppler gradients across the duct, diastolic flow reversal, left atrial dimensions and volume, left ventricular sphericity index, and volumes. The study group was subdivided into 2 subgroups based on the mode of PDA closure whether by coil (n = 42) or device (n = 34). Using univariate analysis there was a highly significant difference between the 2 groups as regard the pulmonary end diameter measured in both the suprasternal and parasternal short-axis views as well as the color flow width and color flow extent (P < .0001). The device closure group had statistically significant higher end-systolic and end-diastolic volumes indexed, left atrial volume, and diastolic flow reversal. Receiver operating characteristic curve analysis showed a pulmonary end diameter cutoff point from the suprasternal view > 2.5 mm and from parasternal short-axis view > 2.61 mm to have the highest balanced sensitivity and specificity to predict the likelihood for device closure (AUC 0.971 and 0.979 respectively). The pulmonary end diameter measured from the suprasternal view was the most independent predictor of device closure. The selection between PDA coil or device closure can be done on the basis of multiple anatomic and hemodynamic echocardiographic variables. © 2017 Wiley Periodicals, Inc.

Techniques for trans-catheter retrieval of embolized Nit-Occlud® PDA-R and ASD-R devices.

PubMed

Sinha, Sanjay; Levi, Daniel; Peirone, Alejandro; Pedra, Carlos

2018-02-15

Nit-Occlud ® (atrial septal defect) ASD-R and (patent ductus arteriosus) PDA-R devices are used outside the United States for percutaneous closure of the patent ductus arteriosus and atrial septal defects. When embolization occurs, these devices have been difficult to retrieve. Bench simulations of retrieval of PDA-R and ASD-R devices were performed in a vascular model. Retrieval of each device was attempted using snare techniques or with bioptome forceps with a range of devices. The same devices were then intentionally embolized in an animal model. Retrieval methods were systematically tested in a range of sheath sizes, and graded in terms of difficulty and retrieval time. Devices that were grasped by the bioptome in the center of the proximal part of the devices were easily retrieved in both models. Bench studies determined the minimum sheath sizes needed for retrieval of each device with this method. In general sheathes two french sizes greater than the delivery sheath were successful with this technique. Three out of the four PDA-R devices were successfully retrieved in vivo. Two were retrieved by grasping the middle of the PA end of the PDA-R device with a Maslanka bioptome and one small PDA-R device was retrieved using a 10 mm Snare. Four of the five ASD-R devices were retrieved successfully grasping the right atrial ASD-R disc or by passing a wire through the device and snaring this loop. For ASD-R 28 and 30 mm devices, a double bioptome technique was needed to retrieve the device. ASD-R and PDA-R devices can be successfully retrieved in the catheterization lab. It is critical to grab the center portion of the right atrial disc of the ASD-R device or pulmonary portion of the PDA-R device and to use adequately sized sheathes. © 2018 Wiley Periodicals, Inc.

A mutation in the tuft mouse disrupts TET1 activity and alters the expression of genes that are crucial for neural tube closure.

PubMed

Fong, Keith S K; Hufnagel, Robert B; Khadka, Vedbar S; Corley, Michael J; Maunakea, Alika K; Fogelgren, Ben; Ahmed, Zubair M; Lozanoff, Scott

2016-05-01

Genetic variations affecting neural tube closure along the head result in malformations of the face and brain. Neural tube defects (NTDs) are among the most common birth defects in humans. We previously reported a mouse mutant called tuft that arose spontaneously in our wild-type 3H1 colony. Adult tuft mice present midline craniofacial malformations with or without an anterior cephalocele. In addition, affected embryos presented neural tube closure defects resulting in insufficient closure of the anterior neuropore or exencephaly. Here, through whole-genome sequencing, we identified a nonsense mutation in the Tet1 gene, which encodes a methylcytosine dioxygenase (TET1), co-segregating with the tuft phenotype. This mutation resulted in premature termination that disrupts the catalytic domain that is involved in the demethylation of cytosine. We detected a significant loss of TET enzyme activity in the heads of tuft embryos that were homozygous for the mutation and had NTDs. RNA-Seq transcriptome analysis indicated that multiple gene pathways associated with neural tube closure were dysregulated in tuft embryo heads. Among them, the expressions of Cecr2, Epha7 and Grhl2 were significantly reduced in some embryos presenting neural tube closure defects, whereas one or more components of the non-canonical WNT signaling pathway mediating planar cell polarity and convergent extension were affected in others. We further show that the recombinant mutant TET1 protein was capable of entering the nucleus and affected the expression of endogenous Grhl2 in IMCD-3 (inner medullary collecting duct) cells. These results indicate that TET1 is an epigenetic determinant for regulating genes that are crucial to closure of the anterior neural tube and its mutation has implications to craniofacial development, as presented by the tuft mouse. © 2016. Published by The Company of Biologists Ltd.

Long-term follow-up for keystone design perforator island flap for closure of myelomeningocele.

PubMed

Donaldson, Christopher; Murday, Hamsaveni K M; Gutman, Matthew J; Maher, Rory; Goldschlager, Tony; Xenos, Chris; Danks, R Andrew

2018-04-01

We have previously reported a small series on the closure of large myelomeningocele (MMC) defects with a keystone design perforator island flap (KDPIF) in a paediatric neurosurgical centre in Australia. We are now presenting an updated longer term follow-up of an expanded series demonstrating longer term durability of this vascularized flap for large myelomeningocele defects. The prospective data from the Monash Neurosurgical Database were used to select all cases of MMC between December 2008 and September 2016. Retrospective analysis of the neurosurgical database revealed an additional three patients who underwent KDPIF closure at the Monash Medical Centre for MMC repair at birth. Wound healing was satisfactory in all six cases. With delayed follow-up, there was no associated skin flap separation, skin flap dehiscence, skin flap necrosis, cerebro-spinal fluid leak, however two infections were encountered, both resolved with conservative management including antibiotics and simple washout. In this expanded case series with increased longevity of follow-up, the keystone design perforator island flap remains a robust alternative for closure of large myelomeningocele defects.

One-stage Reconstruction of Soft Tissue Defects with the Sandwich Technique: Collagen-elastin Dermal Template and Skin Grafts

PubMed Central

Wollina, Uwe

2011-01-01

Background: A full-thickness soft tissue defect closure often needs complex procedures. The use of dermal templates can be helpful in improving the outcome. Objective: The objective was to evaluate a sandwich technique combining the dermal collagen–elastin matrix with skin grafts in a one-stage procedure. Materials and Methods: Twenty-three patients with 27 wounds were enrolled in this prospective single-centre observational study. The mean age was 74.8 ± 17.2 years. Included were full-thickness defects with exposed bone, cartilage and/ or tendons. The dermal collagen–elastin matrix was applied onto the wound bed accomplished by skin transplants, i.e. ‘sandwich’ transplantation. In six wounds, the transplants were treated with intermittent negative pressure therapy. Results: The size of defects was ≤875 cm2. The use of the dermal template resulted in a complete and stable granulation in 100% of wounds. Seventeen defects showed a complete closure and 19 achieved a complete granulation with an incomplete closure. There was a marked pain relief. No adverse events were noted due to the dermal template usage. Conclusions: Sandwich transplantation with the collagen–elastin matrix is a useful tool when dealing with full-thickness soft tissue defects with exposed bone, cartilage or tendons. PMID:22279382

Transcutaneous closure of chronic broncho-pleuro-cutaneous fistula by duct occluder device

PubMed Central

Marwah, Vikas; Ravikumar, R; Rajput, Ashok Kumar; Singh, Amandeep

2016-01-01

Bronchopleural fistula (BPF) is a well known complication of several pulmonary conditions posing challenging management problem and is often associated with high morbidity and mortality. Though no consensus exists on a definite closure management algorithm, strategies for closure widely include various methods like tube thoracostomy with suction, open surgical closure, bronchoscopy directed glue, coiling and sealants which now also includes use of occlusion devices. We report a case in which a novel method of delivery and closure of recurrent post-operative broncho-pleuro-cutaneous fistula by a duct occluder device was done transcutaneously which has not been previously described in literature. PMID:27051115

Early decision-analytic modeling - a case study on vascular closure devices.

PubMed

Brandes, Alina; Sinner, Moritz F; Kääb, Stefan; Rogowski, Wolf H

2015-10-27

As economic considerations become more important in healthcare reimbursement, decisions about the further development of medical innovations need to take into account not only medical need and potential clinical effectiveness, but also cost-effectiveness. Already early in the innovation process economic evaluations can support decisions on development in specific indications or patient groups by anticipating future reimbursement and implementation decisions. One potential concept for early assessment is value-based pricing. The objective is to assess the feasibility of value-based pricing and product design for a hypothetical vascular closure device in the pre-clinical stage which aims at decreasing bleeding events. A deterministic decision-analytic model was developed to estimate the cost-effectiveness of established vascular closure devices from the perspective of the Statutory Health Insurance system. To identify early benchmarks for pricing and product design, three strategies of determining the product's value are explored: 1) savings from complications avoided by the new device; 2) valuation of the avoided complications based on an assumed willingness-to-pay-threshold (the efficiency frontier approach); 3) value associated with modifying the care pathways within which the device would be applied. Use of established vascular closure devices is dominated by manual compression. The hypothetical vascular closure device reduces overall complication rates at higher costs than manual compression. Maximum cost savings of only about €4 per catheterization could be realized by applying the hypothetical device. Extrapolation of an efficiency frontier is only possible for one subgroup where vascular closure devices are not a dominated strategy. Modifying care in terms of same-day discharge of patients treated with vascular closure devices could result in cost savings of €400-600 per catheterization. It was partially feasible to calculate value-based prices for the novel closure device which can be used to inform product design. However, modifying the care pathway may generate much more value from the payers' perspective than modifying the device per se. Manufacturers should thus explore the feasibility of combining reimbursement of their product with arrangements that make same-day discharge attractive also for hospitals. Due to the early nature of the product, the results are afflicted with substantial uncertainty.

Comparison of two spectral domain optical coherence tomography devices for angle-closure assessment.

PubMed

Quek, Desmond T; Narayanaswamy, Arun K; Tun, Tin A; Htoon, Hla M; Baskaran, Mani; Perera, Shamira A; Aung, Tin

2012-08-03

To compare two spectral domain optical coherence tomography (SD-OCT) devices for the identification of angle structures and the presence of angle closure. This was a prospective comparative study. Consecutive patients underwent gonioscopy and anterior segment imaging using two SD-OCT devices (iVue and Cirrus). Images were evaluated for the ability to detect angle structures such as Schwalbe's line (SL), trabecular meshwork (TM), Schlemm's canal (SC), and scleral spur (SS), and the presence of angle closure. Angle closure was defined as iris contact with the angle wall anterior to the SS on SD-OCT, and nonvisibility of the posterior TM on gonioscopy. Angle closure in an eye was defined as ≥two quadrants of closed angles. AC1 statistic was used to assess the agreement between devices. Of the 69 subjects studied (46.4% male, 84.1% Chinese, mean age 64.0 ± 10.5 years), 40 subjects (40 eyes, 58.0%) had angle closure on gonioscopy. The most identifiable structure on Cirrus SD-OCT was the SS (82.2%) and SL on iVue SD-OCT (74.5%). Angle closure was indeterminable in 14.5% and 50.7% of Cirrus and iVue scans (P < 0.001), respectively. Interdevice agreement for angle closure was moderately strong (AC1 = 0.67), but agreement with gonioscopy was only fair (AC1 = 0.35 and 0.50 for Cirrus and iVue, respectively). It was more difficult to determine angle closure status with iVue compared with Cirrus SD-OCT. There was fair agreement between both devices with gonioscopy for identifying angle closure.

Contemporary outcomes of percutaneous closure of patent ductus arteriosus in adolescents and adults.

PubMed

P, Sudhakar; Jose, John; George, Oommen K

Catheter based treatment has gained wide acceptance for management of patent ductus arteriosus (PDA) ever since its introduction. Percutaneous closure in adults can be challenging because of anatomical factors including large sizes, associated pulmonary arterial hypertension (PAH) and co-morbidities. This study aimed to provide comprehensive contemporary data on the safety and efficacy of percutaneous device closure of PDA in adult and adolescent population at a large referral center. This single-center retrospective analysis included 70 patients (33 adolescents and 37 adults) who underwent successful percutaneous device closure of PDA between January 2011 and February 2017.Baseline patient demographics, clinical characteristics, procedural and device related variables, and immediate outcomes during hospital stay were recorded. Patients were followed up for residual shunt and complications. Of 70 PDA device closure cases, 71.4% were females; the mean age was 23 years (range:10-58years). Devices used were 4-Cook's detachable coils, 64-occluders (ADO-I and II, Lifetech, Cardi-O-Fix), 1-vascular plug and 1-ventricular septal occluder device. Device success was achieved in all including those with very large PDAs. At 24-h post-procedure, the success rate of transcatheter intervention was 95.7%. At 6-months follow up, complete closure was observed in all (mean follow up duration-531days). In patients with severe PAH, significant immediate and sustained reduction of the mean pulmonary pressure was observed(77mmHg to 33mmHg;P=0.014). No procedure-related complications including death, device embolization and stenosis of aorta or pulmonary artery occurred. In contemporary practice, percutaneous device closure is an effective and safe treatment option for adolescent and adult PDA patients. Copyright © 2017. Published by Elsevier B.V.

Suitability of Exoseal Vascular Closure Device for Antegrade Femoral Artery Puncture Site Closure

DOE Office of Scientific and Technical Information (OSTI.GOV)

Schmelter, Christopher, E-mail: christopher.schmelter@klinikum-ingolstadt.de; Liebl, Andrea; Poullos, Nektarios

Purpose. To assess the efficacy and safety of the Exoseal vascular closure device for antegrade puncture of the femoral artery. Methods. In a prospective study from February 2011 to January 2012, a total of 93 consecutive patients received a total of 100 interventional procedures via an antegrade puncture of the femoral artery. An Exoseal vascular closure device (6F) was used for closure in all cases. Puncture technique, duration of manual compression, and use of compression bandages were documented. All patients were monitored by vascular ultrasound and color-coded duplex sonography of their respective femoral artery puncture site within 12 to 36more » h after angiography to check for vascular complications. Results. In 100 antegrade interventional procedures, the Exoseal vascular closure device was applied successfully for closure of the femoral artery puncture site in 96 cases (96 of 100, 96.0 %). The vascular closure device could not be deployed in one case as a result of kinking of the vascular sheath introducer and in three cases because the bioabsorbable plug was not properly delivered to the extravascular space adjacent to the arterial puncture site, but instead fully removed with the delivery system (4.0 %). Twelve to 36 h after the procedure, vascular ultrasound revealed no complications at the femoral artery puncture site in 93 cases (93.0 %). Minor vascular complications were found in seven cases (7.0 %), with four cases (4.0 %) of pseudoaneurysm and three cases (3.0 %) of significant late bleeding, none of which required surgery. Conclusion. The Exoseal vascular closure device was safely used for antegrade puncture of the femoral artery, with a high rate of procedural success (96.0 %), a low rate of minor vascular complications (7.0 %), and no major adverse events.« less

Three pledget technique for closure of muscular ventricular septal defects.

PubMed

Sharma, Rajesh; Katewa, Ashish

2012-07-01

We propose a modification of the simple, horizontal mattress, pledgetted suture technique for closing the small muscular ventricular septal defect (VSD) by interposing an oversized third pledget on the left ventricular (LV) aspect of the defect.

Patent foramen ovale closure using a bioabsorbable closure device: safety and efficacy at 6-month follow-up.

PubMed

Van den Branden, Ben J; Post, Martijn C; Plokker, Herbert W; ten Berg, Jurriën M; Suttorp, Maarten J

2010-09-01

The aim of this study was to assess the mid-term safety and efficacy of percutaneous patent foramen ovale (PFO) closure using a bioabsorbable device (BioSTAR, NMT Medical, Boston, Massachusetts). Closure of PFO in patients with cryptogenic stroke has proven to be safe and effective using different types of permanent devices. All consecutive patients who underwent percutaneous PFO closure with the bioabsorbable closure device between November 2007 and January 2009 were included. Residual shunt was assessed using contrast transthoracic echocardiography. Sixty-two patients (55% women, mean age 47.7 ± 11.8 years) underwent PFO closure. The in-hospital complications were a surgical device retrieval in 2 patients (3.2%), device reposition in 1 (1.6%), and a minimal groin hematoma in 6 patients (9.7%). The short-term complications at 1-month follow-up (n = 60) were a transient ischemic attack in the presence of a residual shunt in 1 patient and new supraventricular tachycardia in 7 patients (11.3%). At 6-month follow-up (n = 60), 1 patient without residual shunt developed a transient ischemic attack and 1 developed atrial fibrillation. A mild or moderate residual shunt was noted in 51.7%, 33.9%, and 23.7% after 1-day, 1-month, and 6-month follow-up, respectively. A large shunt was present in 8.3%, 3.4%, and 0% after 1-day, 1-month, and 6-month follow-up. Closure of PFO using the bioabsorbable device is associated with a low complication rate and a low recurrence rate of embolic events. However, a relatively high percentage of mild or moderate residual shunting is still present at 6-month follow-up. Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Non-destructive vacuum decay method for pre-filled syringe closure integrity testing compared with dye ingress testing and high-voltage leak detection.

PubMed

Simonetti, Andrea; Amari, Filippo

2015-01-01

In reaction to the limitations of the traditional sterility test methods, in 2008, the U.S. Food and Drug Administration issued the guidance "Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products" encouraging sterile drug manufacturers to use properly validated physical methods, apart from conventional microbial challenge testing, to confirm container closure integrity as part of the stability protocol. The case study presented in this article investigated the capability of four container closure integrity testing methods to detect simulated defects of different sizes and types on glass syringes, prefilled both with drug product intended for parenteral administration and sterile water. The drug product was a flu vaccine (Agrippal, Novartis Vaccines, Siena, Italy). Vacuum decay, pharmacopoeial dye ingress test, Novartis specific dye ingress test, and high-voltage leak detection were, in succession, the methods involved in the comparative studies. The case study execution was preceded by the preparation of two independent sets of reference prefilled syringes, classified, respectively, as examples of conforming to closure integrity requirements (negative controls) and as defective (positive controls). Positive controls were, in turn, split in six groups, three of with holes laser-drilled through the prefilled syringe glass barrel, while the other three with capillary tubes embedded in the prefilled syringe plunger. These reference populations were then investigated by means of validated equipment used for container closure integrity testing of prefilled syringe commercial production; data were collected and analyzed to determine the detection rate and the percentage of false results. Results showed that the vacuum decay method had the highest performance in terms of detection sensitivity and also ensured the best reliability and repeatability of measurements. An innovative technical solution, preventing possible prefilled syringe plunger movement during container closure integrity testing execution, is presented as well. The growing need to meet sterile drug products' regulatory, quality, and safety expectations has progressively driven new developments and improvements both in container closure integrity testing methods and in the respective equipment, over the last years. Indeed, container closure integrity testing establishes the container closure system capability to provide required protection to the drug product and to demonstrate maintenance of product sterility over its shelf life. This article describes the development of four container closure integrity testing approaches for the evaluation of glass prefilled syringe closure integrity, including two destructive (pharmacopoeial and Novartis specific dye ingress test) and two non-destructive (vacuum decay and high-voltage leak detection) methods. The important finding from the validation of comparative studies was that the vacuum decay method resulted in the most effective, reliable and repeatable detection of defective samples, whether the defect was exposed to sterile water, to drug product, or to air. Complete sets of known defects were created for this purpose (5 μm, 10 μm, 20 μm certified leakages by laser drilled holes and capillary tubes). All investigations and studies were conducted at Bonfiglioli Engineering S.r.l. (Vigarano Pieve, Ferrara, Italy) and at Novartis Vaccines (Sovicille, Siena, Italy). © PDA, Inc. 2015.

Endoscopic full-thickness resection and defect closure in the colon.

PubMed

von Renteln, Daniel; Schmidt, Arthur; Vassiliou, Melina C; Rudolph, Hans-Ulrich; Caca, Karel

2010-06-01

Endoscopic full-thickness resection (eFTR) is a minimally invasive method for en bloc resection of GI lesions. The aim of this pilot study was to evaluate the feasibility of a grasp-and-snare technique for eFTR combined with an over-the-scope clip (OTSC) for defect closure. Nonsurvival animal study. Animal laboratory. Fourteen female domestic pigs. The eFTR was performed in porcine colons using a novel tissue anchor in combination with a standard monofilament snare and 14 mm OTSC. In the first group (n = 20), closure of the colonic defects with OTSC was attempted after the resection. In the second group (n = 8), an endoloop was used to secure the resection base before eFTR was performed. In the first group (n = 20), eFTR specimens ranged from 2.4 to 5.5 cm in diameter. Successful closure was achieved in 9 out of 20 cases. Mean burst pressure for OTSC closure was 29.2 mm Hg (range, 2-90; SD, 29.92). Injury to adjacent organs occurred in 3 cases. Lumen obstruction due to the OTSC closure occurred in 3 cases. In the second group (n = 8), the diameter of specimens ranged from 1.2 to 2.2 cm. Complete closure was achieved in all cases, with a mean burst pressure of 76.6 mm Hg (range, 35-120; SD, 31). Lumen obstruction due to the endoloop closure occurred in one case. No other complications or injuries were observed in the second group. Nonsurvival setting. Colonic eFTR using the grasp-and-snare technique is feasible in an animal model. Ligation of the resection base with an endoloop before eFTR seems to reduce complication rates and improve closure success and leak test results despite yielding smaller specimens. Copyright 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Combined perventricular septal defect closure and patent ductus arteriosus ligation via the lower ministernotomy approach.

PubMed

Voitov, Alexey; Omelchenko, Alexander; Gorbatykh, Yuriy; Bogachev-Prokophiev, Alexander; Karaskov, Alexander

2018-02-01

Over the past decade, minimally invasive approaches have been advocated for surgical correction of congenital defects to reduce costs related to hospitalization and for improved cosmesis. Minimal skin incisions and partial sternotomy reduce surgical trauma, however these techniques might not be successful in treating a number of congenital pathological conditions, particularly for combined congenital defects. We focused on cases with a combined presentation of ventricular septal defect and patent ductus arteriosus. We studied 12 infants who successfully underwent surgical treatment for a combined single-stage ventricular septal defect and patent ductus arteriosus closure through a lower ministernotomy without using cardiopulmonary bypass and X-rays. No intraoperative and early postoperative complications or mortality were noted. Postoperative echocardiography did not reveal residual shunts. The proposed technique is safe and reproducible in infants. © Crown copyright 2017.

Predicting Peri-Device Leakage of Left Atrial Appendage Device Closure Using Novel Three-Dimensional Geometric CT Analysis.

PubMed

Chung, Hyemoon; Jeon, Byunghwan; Chang, Hyuk-Jae; Han, Dongjin; Shim, Hackjoon; Cho, In Jeong; Shim, Chi Young; Hong, Geu-Ru; Kim, Jung-Sun; Jang, Yangsoo; Chung, Namsik

2015-12-01

After left atrial appendage (LAA) device closure, peri-device leakage into the LAA persists due to incomplete occlusion. We hypothesized that pre-procedural three-dimensional (3D) geometric analysis of the interatrial septum (IAS) and LAA orifice can predict this leakage. We investigated the predictive parameters of LAA device closure obtained from baseline cardiac computerized tomography (CT) using a novel 3D analysis system. We conducted a retrospective study of 22 patients who underwent LAA device closure. We defined peri-device leakage as the presence of a Doppler signal inside the LAA after device deployment (group 2, n = 5) compared with patients without peri-device leakage (group 1, n = 17). Conventional parameters were measured by cardiac CT. Angles θ and φ were defined between the IAS plane and the line, linking the LAA orifice center and foramen ovale. Group 2 exhibited significantly better left atrial (LA) function than group 1 (p = 0.031). Pre-procedural θ was also larger in this group (41.9° vs. 52.3°, p = 0.019). The LAA cauliflower-type morphology was more common in group 2. Overall, the patients' LA reserve significantly decreased after the procedure (21.7 mm(3) vs. 17.8 mm(3), p = 0.035). However, we observed no significant interval changes in pre- and post-procedural values of θ and φ in either group (all p > 0.05). Angles between the IAS and LAA orifice might be a novel anatomical parameter for predicting peri-device leakage after LAA device closure. In addition, 3D CT analysis of the LA and LAA orifice could be used to identify clinically favorable candidates for LAA device closure.

Challenges in device closure of a large patent ductus arteriosus in infants weighing less than 6 kg.

PubMed

Vijayalakshmi, I B; Chitra, Narasimhan; Praveen, Jayan; Prasanna, Simha Rao

2013-02-01

Transcatheter closure of patent ductus arteriosus (PDA) has replaced surgery in most institutions. Despite improvements in techniques and the devices available, closure of large PDA in very small infants remains a challenge. To assess the challenges, feasibility, and efficacy of device closure of large PDA, in infants weighing ≤6 kg. Analysis of device closure of a PDA was done in 61 infants ≤6 kg. Their ages, ranged from 9 days-12 months (mean 8.9 months), weight ranged from 2.2 to 6 kg (mean 5.3 kg), and PDA measured 3.2-8.7 mm (mean 4.8 mm). The fluoroscopy time was 3-18 minutes. The largest device used was 12 × 10 mm. Successful device placement was achieved in 60/61 infants (98.4%). Mild aortic obstruction occurred in 2 cases (3.3%), as the device got displaced towards the aorta after release. The device embolized in 2 cases (3.3%). In one it was retrieved by a novel method like fastening the screw in the aorta and was closed with a 4 × 6 ADO II. In the other infant, with a single kidney, died of uremia after device retrieval. Mild left pulmonary artery (LPA) obstruction occurred in one case (1.6%). Four cases (6.6%) had minor vascular complications. The postprocedure weight gain after 3 months was between 2.5 kg ± 250 mg. Device closure of large PDA in infants weighing ≤6 kg with left ventricular failure is challenging but possible, safe and effective. Retrieval of embolized device could be tricky. © 2012, Wiley Periodicals, Inc.

[Application of modified adjustable skin stretching and secure wound-closure system in repairing of skin and soft tissue defect].

PubMed

Dong, Qiqiang; Gu, Guojun; Wang, Lijun; Fu, Keda; Xie, Shuqiang; Zhang, Songjian; Zhang, Huafeng; Wu, Zhaosen

2017-12-01

To investigate the application of modified adjustable skin stretching and secure wound-closure system in repairing of skin and soft tissue defect. Between March 2016 and April 2017, 21 cases of skin and soft tissue defects were repaired with the modified adjustable skin stretching and secure wound-closure system (the size of regulating pressure and the times of adjustment were determined according to the color, temperature, capillary response, and swelling degree of the skin edge). There were 11 males and 10 females, with an average age of 49.2 years (range, 21-67 years). Among them, 1 case was the residual wound after amputation of leg; 18 cases were the wounds after traumatic injury operation, including 4 cases in the lower leg, 3 cases in the knee joint, 7 cases in the upper limb, and 4 cases in the foot; and 2 cases were diabetic feet. The skin defect area ranged from 4.0 cm×2.5 cm to 21.0 cm×10.0 cm. Skin defect wounds closed directly in one stage in 4 cases; 12 cases were closed after continuously stretching for 5-14 days (mean, 10 days); 5 cases were reduced to less than one-half area, and the wound healed after the second skin grafting or flap repairing. All the 21 patients were followed up 3-12 months (mean, 5.2 months). The wound was linear healing with small scar, and no invasive margin, poor blood flow, necrosis, and poor sensory function happened. The modified adjustable skin stretching and secure wound-closure system can reduce the skin and soft tissue defects or close the wound directly, and even replace the skin graft and skin flap repairing. It was a good method for the treatment of skin and soft tissue defect.

A new coated nitinol occluder for transcatheter closure of ventricular septal defects in a canine model.

PubMed

Zhou, Yong; Chen, Feng; Huang, Xinmiao; Zhao, Xianxian; Wu, Hong; Bai, Yuan; Qin, Yongwen

2013-01-01

This study evaluated feasibility and safety of implanting the polyester-coated nitinol ventricular septal defect occluder (pcVSDO) in the canine model. VSD models were successfully established by transseptal ventricular septal puncture via the right jugular vein in 15 out of 18 canines. Two types of VSDOs were implanted, either with pcVSDOs (n = 8) as the new type occluder group or with the commercial ventricular septal defect occluders (VSDOs, n = 7, Shanghai Sharp Memory Alloy Co. Ltd.) as the control group. Sheath size was 10 French (10 Fr) in two groups. Then the general state of the canines was observed after implantation. ECG and TTE were performed, respectively, at 7, 30, 90 days of follow-up. The canines were sacrificed at these time points for pathological and scanning electron microscopy examination. The devices were successfully implanted in all 15 canines and were retrievable and repositionable. There was no thrombus formation on the device or occurrence of complete heart block. The pcVSDO surface implanted at day 7 was already covered with neotissue by gross examination, and it completed endothelialization at day 30, while the commercial VSDO was covered with the neotissue in 30th day and the complete endothelialization in 90th day. The study shows that pcVSDO is feasible and safe to close canine VSD model and has good biocompatibility and shorter time of endothelialization.

Management of a large mucosal defect after duodenal endoscopic resection

PubMed Central

Fujihara, Shintaro; Mori, Hirohito; Kobara, Hideki; Nishiyama, Noriko; Matsunaga, Tae; Ayaki, Maki; Yachida, Tatsuo; Masaki, Tsutomu

2016-01-01

Duodenal endoscopic resection is the most difficult type of endoscopic treatment in the gastrointestinal tract (GI) and is technically challenging because of anatomical specificities. In addition to these technical difficulties, this procedure is associated with a significantly higher rate of complication than endoscopic treatment in other parts of the GI tract. Postoperative delayed perforation and bleeding are hazardous complications, and emergency surgical intervention is sometimes required. Therefore, it is urgently necessary to establish a management protocol for preventing serious complications. For instance, the prophylactic closure of large mucosal defects after endoscopic resection may reduce the risk of hazardous complications. However, the size of mucosal defects after endoscopic submucosal dissection (ESD) is relatively large compared with the size after endoscopic mucosal resection, making it impossible to achieve complete closure using only conventional clips. The over-the-scope clip and polyglycolic acid sheets with fibrin gel make it possible to close large mucosal defects after duodenal ESD. In addition to the combination of laparoscopic surgery and endoscopic resection, endoscopic full-thickness resection holds therapeutic potential for difficult duodenal lesions and may overcome the disadvantages of endoscopic resection in the near future. This review aims to summarize the complications and closure techniques of large mucosal defects and to highlight some directions for management after duodenal endoscopic treatment. PMID:27547003

Comparison of holding strength of suture anchors for hepatic and renal parenchyma.

PubMed

Ames, Caroline D; Perrone, Juan M; Frisella, Alison J; Morrissey, Kevin; Landman, Jaime

2005-12-01

Various laparoscopic devices have been described for suture anchoring during solidorgan parenchymal closure. Application of these devices expedites the closure of parenchymal defects and minimizes ischemia time. We compared different technologies as suture anchors for parenchymal closure. A tensometer was used to determine the amount of tension necessary to dislodge each of five different clips from Vicryl suture alone or against two different substrates (fresh pig kidney and liver) with and without an intervening pledget. The clips investigated were the Lapra-Ty (Ethicon), Endoclip II (US Surgical), small Horizon Ligating Clips (Weck), Hem-o-lok Medium Polymer Clips (Week), and a novel Suture-clip (Applied Medical). ANOVA and two-sided Fisher's exact test provided statistical analysis. The force required to dislodge the Lapra-Ty clip from bare suture for both 0 and 1 Vicryl (7.0 N) was approximately fourfold the force required to dislodge the Endoclips or the 5-mm or 10-mm Hem-o-lok clips (p<0.01). When clips were applied to suture running through renal or liver parenchyma, the novel Suture-clip required the greatest tension to dislodge (P<0.01), followed by the Horizon and Lapra-Ty clips. There were no statistically significant differences in the tension required to dislodge a given clip from the two parenchymal substrates or in the presence or absence of a pledget. In our experimental model, the Suture-clip, Lapra-Ty, and Horizon clips required significantly greater tension to dislodge than the Hem-o-lok and Endoclip clips. The addition of a pledget did not improve tension resistance.

Congenital defects of the pericardium.

PubMed

Drury, Nigel E; De Silva, Ravi J; Hall, Roger M O; Large, Stephen R

2007-04-01

Congenital defects of the pericardium are rare, but when they are reported they are frequently associated with other cardiac lesions. We describe a case of partial pericardial defect found incidentally at surgery for closure of an ostium primum atrial septal defect. Proposed mechanisms of pericardial defect development are discussed and we suggest that associations with congenital and acquired heart disease are mostly circumstantial.

Insights into Metabolic Mechanisms Underlying Folate-Responsive Neural Tube Defects: A Minireview

PubMed Central

Beaudin, Anna E.; Stover, Patrick J.

2015-01-01

Neural tube defects (NTDs), including anencephaly and spina bifida, arise from the failure of neurulation during early embryonic development. Neural tube defects are common birth defects with a heterogenous and multifactorial etiology with interacting genetic and environmental risk factors. Although the mechanisms resulting in failure of neural tube closure are unknown, up to 70% of NTDs can be prevented by maternal folic acid supplementation. However, the metabolic mechanisms underlying the association between folic acid and NTD pathogenesis have not been identified. This review summarizes our current understanding of the mechanisms by which impairments in folate metabolism might ultimately lead to failure of neural tube closure, with an emphasis on untangling the relative contributions of nutritional deficiency and genetic risk factors to NTD pathogenesis. PMID:19180567

Echocardiographic Follow-Up of Patent Foramen Ovale and the Factors Affecting Spontaneous Closure.

PubMed

Yildirim, Ali; Aydin, Alperen; Demir, Tevfik; Aydin, Fatma; Ucar, Birsen; Kilic, Zubeyir

2016-11-01

The aim of the present study was to evaluate the echocardiographic follow-up of patent foramen ovale, which is considered a potential etiological factor in various diseases, and to determine the factors affecting spontaneous closure. Between January 2000 and June 2012, records of 918 patients with patent foramen ovale were retrospectively reviewed. Patency of less than 3 mm around the fossa ovalis is called patent foramen ovale. Patients with cyanotic congenital heart diseases, severe heart valve disorders and severe hemodynamic left to right shunts were excluded from the study. The patients were divided into three groups based on age; 1 day-1 month in group 1, 1 month-12 months in group 2, and more than 12 months in group 3. Of the 918 patients, 564 (61.4%) had spontaneous closure, 328 (35.8%) had patent foramen ovale continued, 15 (1.6%) patients had patent foramen ovale enlarged to 3-5 mm, 6 patients were enlarged to 5-8 mm, and in one patient patent foramen ovale reached to more than 8 mm size. Defect was spontaneously closed in 65.9% of the patients in group 1, 66.7% of the patients in group 2, and 52.3% of the patients in group 3. There was a negative correlation between the age of diagnosis and spontaneous closure (p < 0.05). Gender, prematurity and coexisting malformations such as patent ductus arteriosus and atrial septal aneurysm did not have any effect on spontaneous closure of patent foramen ovale (p > 0.05). However, ventricular septal defect and spontaneous closure of patent foramen ovale had a positive correlation (p < 0.01). No correlation was noted between the existence of atrial septal aneurysm, prematurity, and maturity of the patients. The present study demonstrated that spontaneous closure rate of patent foramen ovale is high. Furthermore, a positive correlation was found between spontaneous closure of patent foramen ovale with early diagnosis and small defect size.

Does the use of an acellular dermal graft in abdominal closure after rectus flap harvest impact the occurrence of post-operative hernia?

PubMed

Saman, Masoud; Kadakia, Sameep; Ducic, Yadranko

2015-12-01

Patients with rectus free flap harvest extending below the arcuate line are predisposed to postoperative hernia formation. As such, many authors have advocated the use of closure adjuncts to increase the integrity of the closure and prevent hernia or abdominal wall bulging. Busy level 1 public trauma center in metropolitan Fort Worth, Texas Following harvest of the rectus free flap, 48 patients underwent primary closure; 24 of these patients had defects extending below the arcuate line. Forty patients were closed with an acellular dermal graft; 22 of these patients had defects extending below the arcuate line. Postoperative hernia formation and local infection rate were examined in a minimum follow-up period of 1 year. Regardless of closure method, no hernias were observed in the postoperative period. Using an unpaired t test and an alpha value of 0.05, there was no statistically significant difference in the infection rate between the two groups. Following rectus abdominis myocutaneous free flap harvest, the use of an acellular dermal graft in abdominal wall closure may not be of any further advantage in the prevention of hernia. Retrospective (Level III).

Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy.

PubMed

Victor, Ken G; Levac, Lauren; Timmins, Michael; Veale, James

2017-01-01

USP <1207.1> Section 3.5 states that "A deterministic leak test method having the ability to detect leaks at the product's maximum allowable leakage limit is preferred when establishing the inherent integrity of a container-closure system." Ideally, container closure integrity of parenteral packaging would be evaluated by measuring a physical property that is sensitive to the presence of any package defect that breaches package integrity by increasing its leakage above its maximum allowable leakage limit. The primary goals of the work presented herein were to demonstrate the viability of the nondestructive, deterministic method known as laser-based gas headspace analysis for evaluating container closure integrity and to provide a physical model for predicting leak rates for a variety of container volumes, headspace conditions, and defect sizes. The results demonstrate that laser-based headspace analysis provides sensitive, accurate, and reproducible measurements of the gas ingress into glass vial-stopper package assemblies that are under either diffusive or effusive leak conditions. Two different types of positive controls were examined. First, laser-drilled micro-holes in thin metal disks that were crimped on top of 15R glass vials served as positive controls with a well-characterized defect geometry. For these, a strong correlation was observed between the measured ingress parameter and the size of the defect for both diffusive and effusive conditions. Second, laser-drilled holes in the wall of glass vials served as controls that more closely simulate real-world defects. Due to their complex defect geometries, their diffusive and effusive ingress parameters did not necessarily correlate; this is an important observation that has significant implications for standardizing the characterization of container defects. Regardless, laser-based headspace analysis could readily differentiate positive and negative controls for all leak conditions, and the results provide a guide for method development of container closure integrity tests. LAY ABSTRACT: The new USP 39 <1207>, "Package Integrity Evaluation-Sterile Products", states in section 3.4.1: "tracer gas tests performed using … laser-based gas headspace analysis [have] been shown to be sensitive enough to quantitatively analyze leakage through the smallest leak paths found to pose the smallest chance of liquid leakage or microbial ingress in rigid packaging." In addition, USP <1207> also states that "for such methods, the limit of detection can be mathematically predicted on the basis of gas flow kinetics." Using the above statements as a foundation, this paper presents a theoretical basis for predicting the gas ingress through well-defined defects in product vials sealed under a variety of headspace conditions. These calculated predictions were experimentally validated by comparing them to measurements of changes in the headspace oxygen content or total pressure for several different positive controls using laser-based headspace analysis. The results demonstrated that laser-based headspace analysis can, by readily differentiating between negative controls and positive controls with a range of defect sizes on the micron scale, be used to assess container closure integrity. The work also demontrated that caution must be used when attempting to correlate a leak rate to an idealized defect-size parameter. © PDA, Inc. 2017.

Performance characteristics of a novel blood bag in-line closure device and subsequent product quality assessment

PubMed Central

Serrano, Katherine; Levin, Elena; Culibrk, Brankica; Weiss, Sandra; Scammell, Ken; Boecker, Wolfgang F; Devine, Dana V

2010-01-01

BACKGROUND In high-volume processing environments, manual breakage of in-line closures can result in repetitive strain injury (RSI). Furthermore, these closures may be incorrectly opened causing shear-induced hemolysis. To overcome the variability of in-line closure use and minimize RSI, Fresenius Kabi developed a new in-line closure, the CompoFlow, with mechanical openers. STUDY DESIGN AND METHODS The consistency of the performance of the CompoFlow closure device was assessed, as was its effect on component quality. A total of 188 RBC units using CompoFlow blood bag systems and 43 using the standard bag systems were produced using the buffy coat manufacturing method. Twenty-six CompoFlow platelet (PLT) concentrates and 10 control concentrates were prepared from pools of four buffy coats. RBCs were assessed on Days 1, 21, and 42 for cellular variables and hemolysis. PLTs were assessed on Days 1, 3, and 7 for morphology, CD62P expression, glucose, lactate, and pH. A total of 308 closures were excised after processing and the apertures were measured using digital image analysis. RESULTS The use of the CompoFlow device significantly improved the mean extraction time with 0.46 ± 0.11 sec/mL for the CompoFlow units and 0.52 ± 0.13 sec/mL for the control units. The CompoFlow closures showed a highly reproducible aperture after opening (coefficient of variation, 15%) and the device always remained opened. PLT and RBC products showed acceptable storage variables with no differences between CompoFlow and control. CONCLUSIONS The CompoFlow closure devices improved the level of process control and processing time of blood component production with no negative effects on product quality. PMID:20529007

Prospective Comparison of Collagen Plug (Angio-Seal™) and Suture-Mediated (the Closer S™) Closure Devices at Femoral Access Sites

PubMed Central

Park, Yulri; Choo, Sung Wook; Lee, Sung Hoon; Shin, Sung Wook; Do, Young Soo; Byun, Hong Sik; Park, Kwang Bo; Jeon, Pyoung

2005-01-01

Objective Rapid and effective hemostasis at femoral puncture sites minimizes both the hospital stay and patient discomfort. Therefore, a variety of arterial closure devices have been developed to facilitate the closure of femoral arteriotomy. The objective of this prospective study was to compare the efficacy of two different closure devices; a collagen plug device (Angio-Seal) and a suture-mediated closure device (the Closer S). Materials and Methods From March 28, 2003 to August 31, 2004, we conducted a prospective study in which 1,676 cases of 1,180 patients were treated with two different types of closure device. Angio-Seal was used in 961 cases and the Closer S in 715 cases. The efficacy of the closure devices was assessed, as well as complications occurring at the puncture sites. Results Successful immediate hemostasis was achieved in 95.2% of the cases treated with Angio-Seal, and in 89.5% of the cases treated with the Closer S (p < 0.05). The rates of minor and major complications occurring between the two groups were not significantly different. In the Closer S group, we observed four major complications (0.6%), that consisted of one massive retroperitoneal hemorrhage (surgically explored) and three pseudoaneurysms. In the Angio-Seal group, we observed three major complications (0.3%) that consisted of one femoral artery occlusion, one case of infection treated with intravenous antibiotics and one pseudoaneurysm. Conclusion The use of Angio-Seal was found to be more effective than that of the Closer S with regard to the immediate hemostasis of the femoral puncture sites. However, we detected no significant differences in the rate at which complications occurred. PMID:16374083

Tactical Sensors for Dispersed TNF (Tactical Nuclear Force) Units. Appendix 1.Tactical Sensory Survey.

DTIC Science & Technology

1983-06-30

activating a separate transmitter, audible alarm, or contact closure. This sensor is compatible with any device that utilizes an input pulse or...transmitter, audible alarm, or contact closure. This sensor is compatible *i with any device that utilizes an output to produce an alarm. 110-4769-002. This...used to generate an alarm by activating a separate transmitter, audible alarm, or contact closure. This sensor is compatible with any device that

Transcatheter closure of patent ductus arteriosus: past, present and future.

PubMed

Baruteau, Alban-Elouen; Hascoët, Sébastien; Baruteau, Julien; Boudjemline, Younes; Lambert, Virginie; Angel, Claude-Yves; Belli, Emre; Petit, Jérôme; Pass, Robert

2014-02-01

This review aims to describe the past history, present techniques and future directions in transcatheter treatment of patent ductus arteriosus (PDA). Transcatheter PDA closure is the standard of care in most cases and PDA closure is indicated in any patient with signs of left ventricular volume overload due to a ductus. In cases of left-to-right PDA with severe pulmonary arterial hypertension, closure may be performed under specific conditions. The management of clinically silent or very tiny PDAs remains highly controversial. Techniques have evolved and the transcatheter approach to PDA closure is now feasible and safe with current devices. Coils and the Amplatzer Duct Occluder are used most frequently for PDA closure worldwide, with a high occlusion rate and few complications. Transcatheter PDA closure in preterm or low-bodyweight infants remains a highly challenging procedure and further device and catheter design development is indicated before transcatheter closure is the treatment of choice in this delicate patient population. The evolution of transcatheter PDA closure from just 40 years ago with 18F sheaths to device delivery via a 3F sheath is remarkable and it is anticipated that further improvements will result in better safety and efficacy of transcatheter PDA closure techniques. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

MANTA, a novel plug-based vascular closure device for large bore arteriotomies: technical report.

PubMed

van Gils, Lennart; Daemen, Joost; Walters, Greg; Sorzano, Todd; Grintz, Todd; Nardone, Sam; Lenzen, Mattie; De Jaegere, Peter P T; Roubin, Gary; Van Mieghem, Nicolas M

2016-09-18

Catheter-based interventions have become a less invasive alternative to conventional surgical techniques for a wide array of cardiovascular diseases but often create large arteriotomies. A completely percutaneous technique is attractive as it may reduce the overall complication rate and procedure time. Currently, large bore arteriotomy closure relies on suture-based techniques. Access-site complications are not uncommon and often seem related to closure device failure. The MANTA VCD is a novel collagen-based closure device that specifically targets arteriotomies between 10 and 22 Fr. This technical report discusses the MANTA design concept, practical instructions for use and preliminary clinical experience.

Initial experience with the Cardiva Boomerang vascular closure device in diagnostic catheterization.

PubMed

Doyle, Brendan J; Godfrey, Michael J; Lennon, Ryan J; Ryan, James L; Bresnahan, John F; Rihal, Charanjit S; Ting, Henry H

2007-02-01

The authors studied the safety and efficacy of the Cardiva Boomerang vascular closure device in patients undergoing diagnostic cardiac catheterization. Conventional vascular closure devices (sutures, collagen plugs, or metal clips) have been associated with catastrophic complications including arterial occlusion and foreign body infections; furthermore, they cannot be utilized in patients with peripheral vascular disease or vascular access site in a vessel other than the common femoral artery. The Cardiva Boomerang device facilitates vascular hemostasis without leaving any foreign body behind at the access site, can be used in peripheral vascular disease, and can be used in vessels other than the common femoral artery A total of 96 patients undergoing transfemoral diagnostic cardiac catheterization were included in this study, including 25 (26%) patients with contraindications to conventional closure devices. Femoral angiography was performed prior to deployment of the Cardiva Boomerang closure device. Patients were ambulated at 1 hr after hemostasis was achieved. The device was successfully deployed and hemostasis achieved with the device alone in 95 (99%) patients. The device failed to deploy in 1 (1%) patient and required conversion to standard manual compression. Minor complications were observed in 5 (5%) patients. No patients experienced major complications including femoral hematoma > 4 cm, red blood cell transfusion, retroperitoneal bleed, arteriovenous fistula, pseudoaneurysm, infection, arterial occlusion, or vascular surgery. The Cardiva Boomerang device is safe and effective in patients undergoing diagnostic cardiac catheterization using the transfemoral approach, facilitating early ambulation with low rates of vascular complications. (c) 2006 Wiley-Liss, Inc.

Durability of central aortic valve closure in patients with continuous flow left ventricular assist devices.

PubMed

McKellar, Stephen H; Deo, Salil; Daly, Richard C; Durham, Lucian A; Joyce, Lyle D; Stulak, John M; Park, Soon J

2014-01-01

A competent aortic valve is essential to providing effective left ventricular assist device support. We have adopted a practice of central aortic valve closure by placing a simple coaptation stitch at left ventricular assist device implantation in patients with significant aortic insufficiency. We conducted a follow-up study to evaluate the efficacy and durability of this procedure. The study included patients who had undergone continuous flow left ventricular assist device implantation. The patients were divided into 2 groups, those who did not require any aortic procedure because the valve was competent and those who underwent central aortic valve closure for mild or greater aortic regurgitation. The clinical endpoints were mortality, progression or recurrence of aortic insufficiency, and reoperation for aortic valve pathologic features. Aortic insufficiency was measured qualitatively from mild to severe on a scale of 0 to 5. A total of 123 patients received continuous flow left ventricular assist devices from February 2007 to August 2011. Of those, 18 (15%) underwent central aortic valve closure at left ventricular assist device implantation because of significant aortic insufficiency (1.8 ± 1.4) and 105 who did not (competent aortic valve, 0.15 ± 0.43; P < .01). At follow-up (median, 312 days; range, 0-1429 days), the mean aortic insufficiency score remained low for the patients with central aortic valve closure (0.27 ± 0.46) in contrast to those without central aortic valve closure who experienced aortic insufficiency progression (0.78 ± 0.89; P = .02). In addition, the proportion of patients with more than mild aortic insufficiency was significantly less in the central aortic valve closure group (0% vs 18%; P = .05). The patients in the central aortic valve closure group were significantly older and had a greater incidence of renal failure at baseline. The 30-day mortality was greater in the central aortic valve closure group, but the late survival was similar between the 2 groups. No reoperations were required for recurrent aortic insufficiency. The results of our study have shown that repair of aortic insufficiency with a simple central coaptation stitch is effective and durable in left ventricular assist device-supported patients, with follow-up extending into 2 years. Although aortic insufficiency progressed over time in those with minimal native valve regurgitation initially, no such progression was noted in those with central aortic valve closure. Additional investigation is needed to evaluate whether prophylactic central aortic valve closure should be performed at left ventricular assist device implantation to avoid problematic aortic regurgitation developing over time, in particular in patients undergoing left ventricular assist device implantation for life-long (destination therapy) support. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Modified off-midline closure of pilonidal sinus disease.

PubMed

Saber, Aly

2014-05-01

Numerous surgical procedures have been described for pilonidal sinus disease, but treatment failure and disease recurrence are frequent. Conventional off-midline flap closures have relatively favorable surgical outcomes, but relatively unfavorable cosmetic outcomes. The author reported outcomes of a new simplified off-midline technique for closure of the defect after complete excision of the sinus tracts. Two hundred patients of both sexes were enrolled for modified D-shaped excisions were used to include all sinuses and their ramifications, with a simplified procedure to close the defect. The overall wound infection rate was 12%, (12.2% for males and 11.1% for females). Wound disruption was necessitating laying the whole wound open and management as open technique. The overall wound disruption rate was 6%, (6.1% for males and 5.5% for females) and the overall recurrence rate was 7%. Our simplified off-midline closure without flap appeared to be comparable to conventional off-midline closure with flap, in terms of wound infection, wound dehiscence, and recurrence. Advantages of the simplified procedure include potentially reduced surgery complexity, reduced surgery time, and improved cosmetic outcome.

Frizzled 1 and frizzled 2 genes function in palate, ventricular septum and neural tube closure: general implications for tissue fusion processes

PubMed Central

Yu, Huimin; Smallwood, Philip M.; Wang, Yanshu; Vidaltamayo, Roman; Reed, Randall; Nathans, Jeremy

2010-01-01

The closure of an open anatomical structure by the directed growth and fusion of two tissue masses is a recurrent theme in mammalian embryology, and this process plays an integral role in the development of the palate, ventricular septum, neural tube, urethra, diaphragm and eye. In mice, targeted mutations of the genes encoding frizzled 1 (Fz1) and frizzled 2 (Fz2) show that these highly homologous integral membrane receptors play an essential and partially redundant role in closure of the palate and ventricular septum, and in the correct positioning of the cardiac outflow tract. When combined with a mutant allele of the planar cell polarity gene Vangl2 (Vangl2Lp), Fz1 and/or Fz2 mutations also cause defects in neural tube closure and misorientation of inner ear sensory hair cells. These observations indicate that frizzled signaling is involved in diverse tissue closure processes, defects in which account for some of the most common congenital anomalies in humans. PMID:20940229

The Flatstent versus the conventional umbrella devices in the percutaneous closure of patent foramen ovale.

PubMed

Aral, Mert; Mullen, Michael

2015-05-01

Patent foramen ovale (PFO) has been associated with paradoxical embolism leading to stroke/transient ischemic attack, migraine, and neurological decompression sickness. In search for the optimal device that would achieve effective clinical closure with minimal complications, a better device selection based on PFO anatomy and improvements in device design is needed. The Flatstent is a new device designed to treat the highly prevalent long-tunnel PFOs from within, minimizing the amount of material left behind in an attempt to reduce device-related complications. The objective is to compare the safety and efficacy of the novel Flatstent versus the conventional umbrella devices in the transcatheter closure of PFO in a nonrandomized, retrospective, single-center study. Between March 2010 and March 2013, 88 patients underwent PFO closure at The Heart Hospital, London with either the novel Flatstent or one of the four conventionally used umbrella devices (GORE Helex Septal Occluder, Occlutech Figulla Flex, Biostar Septal Occluder, and Amplatzer PFO Occluder) depending on their PFO anatomy. Patients were then evaluated with contrast transthoracic echocardiography (TTE) and/or transoesophageal echocardiography (TOE) at 6 weeks and 1 year after the procedure. The residual shunt and complication rates between the Flatstent and umbrella devices were compared. The Flatstent was used in 27 patients (30.7%), whereas 61 patients (69.3%) received one of the four umbrella devices. Primary efficacy point of clinical closure defined as grade 0 or grade 1; residual shunt was achieved in 81.3% in the Flatstent cohort and 80.3% in the umbrella device group at 6 weeks follow-up. At 1 year, the clinical closure rates reached 92.6 and 91.8%. There were two device embolizations, one in each cohort during the immediate postoperative period (<24 hrs), with successful retrieval. One patient in the umbrella device group developed transient atrial fibrillation, which was controlled medically. Event recurrence rate was 0% at 1 year. No difference was found in closure or complication rates between the Flatstent and the umbrella devices. With appropriate preassessment of the PFO anatomy, the Flatstent works as a safe and effective method of treating the PFO from within the tunnel, especially in those with long-tunnel PFOs. Longer follow-up is needed to establish superiority. © 2014 Wiley Periodicals, Inc.

Computational Modeling and Simulation of Genital Tubercle Development

EPA Science Inventory

Hypospadias is a developmental defect of urethral tube closure that has a complex etiology. Here, we describe a multicellular agent-based model of genital tubercle development that simulates urethrogenesis from the urethral plate stage to urethral tube closure in differentiating ...

27 CFR 26.136 - Affixing closures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Closures for Distilled Spirits From Puerto Rico § 26.136 Affixing closures. Closures or other devices shall be securely...

27 CFR 26.136 - Affixing closures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... OF THE TREASURY ALCOHOL LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Closures for Distilled Spirits From Puerto Rico § 26.136 Affixing closures. Closures or other devices shall be securely...

27 CFR 26.136 - Affixing closures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Closures for Distilled Spirits From Puerto Rico § 26.136 Affixing closures. Closures or other devices shall be securely...

27 CFR 26.136 - Affixing closures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... OF THE TREASURY ALCOHOL LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Closures for Distilled Spirits From Puerto Rico § 26.136 Affixing closures. Closures or other devices shall be securely...

27 CFR 26.136 - Affixing closures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... OF THE TREASURY LIQUORS LIQUORS AND ARTICLES FROM PUERTO RICO AND THE VIRGIN ISLANDS Closures for Distilled Spirits From Puerto Rico § 26.136 Affixing closures. Closures or other devices shall be securely...

Logarithmic spiral flap for circular or oval defects on the lateral surface of the nose and nasal ala: a series of 15 cases.

PubMed

Moreno-Artero, E; Redondo, P

2015-10-01

A large number of flaps, particularly rotation and transposition flaps, have been described for the closure of skin defects left by oncologic surgery of the nose. The logarithmic spiral flap is a variant of the rotation flap. We present a series of 15 patients with different types of skin tumor on the nose. The skin defect resulting from excision of the tumor by micrographic surgery was reconstructed using various forms of the logarithmic spiral flap. There are 3 essential aspects to flap design: commencement of the pedicle at the upper or lower border of the wound, a width of the distal end of the flap equal to the vertical diameter of the defect, and a progressive increase in the radius of the spiral from the distal end of the flap to its base. The cosmetic and functional results of surgical reconstruction were satisfactory, and no patient required additional treatment to improve scar appearance. The logarithmic spiral flap is useful for the closure of circular or oval defects situated on the lateral surface of the nose and nasal ala. The flap initiates at one of the borders of the wound as a pedicle with a radius that increases progressively to create a spiral. We propose the logarithmic spiral flap as an excellent option for the closure of circular or oval defects of the nose. Copyright © 2015 Elsevier España, S.L.U. and AEDV. All rights reserved.

Transcatheter Closure of Patent Foramen Ovale: Devices and Technique.

PubMed

Price, Matthew J

2017-10-01

Transcatheter closure of a patent foramen ovale (PFO) reduces the risk of recurrent cryptogenic stroke compared with medical therapy. PFO closure is a prophylactic procedure, and will not provide the patient with symptomatic improvement, except in cases of hypoxemia due to right-to-left shunt or possibly migraine headaches. Therefore, appropriate patient selection is critical, and procedural safety is paramount. Herein, we review key characteristics of the devices currently available for transcatheter PFO closure within the United States, and highlight key technical aspects of the PFO closure procedure that will maximize procedural success. Copyright © 2017 Elsevier Inc. All rights reserved.

Transapical access closure: the TA PLUG device†

PubMed Central

Brinks, Henriette; Nietlispach, Fabian; Göber, Volkhard; Englberger, Lars; Wenaweser, Peter; Meier, Bernhard; Carrel, Thierry; Huber, Christoph

2013-01-01

OBJECTIVES Percutaneous closure of the transapical (TA) access site for large-calibre devices is an unsolved issue. We report the first experimental data on the TA PLUG device for true-percutaneous closure following large apical access for transcatheter aortic valve implantation. METHODS The TA PLUG, a self-sealing full-core closure device, was implanted in an acute animal study in six pigs (60.2 ± 0.7 kg). All the pigs received 100 IU/kg of heparin. The targeted activated clotting time was left to normalize spontaneously. After accessing the left ventricular apex with a 39 French introducer, the closure plug device was delivered with a 33 French over-the-wire system under fluoroscopic guidance into the apex. Time to full haemostasis as well as rate of bleeding was recorded. Self-anchoring properties were assessed by haemodynamic push stress under adrenalin challenge. An additional feasibility study was conducted in four pigs (58.4 ± 1.1 kg) with full surgical exposure of the apex, and assessed device anchoring by pull-force measurements with 0.5 Newton (N) increments. All the animals were electively sacrified. Post-mortem analysis of the heart was performed and the renal embolic index assessed. RESULTS Of six apical closure devices, five were correctly inserted and fully deployed at the first attempt. One became blocked in the delivery system and was placed successfully at the second attempt. In all the animals, complete haemostasis was immediate and no leak was recorded during the 5-h observation period. Neither leak nor any device dislodgement was observed under haemodynamic push stress with repeated left ventricular peak pressure of up to 220 mmHg. In the feasibility study assessing pull-stressing, device migration occurred at a force of 3.3 ± 0.5 N corresponding to 247.5 mmHg. Post-mortem analyses confirmed full expansion of all devices at the intended target. No macroscopic damage was identified at the surrounding myocardium. The renal embolic index was zero. CONCLUSIONS True-percutaneous left ventricular apex closure following large access is feasible with the self-sealing TA PLUG. The device allows for immediate haemostasis and a reliable anchoring in the acute animal setting. This is the first report of a true-percutaneous closure for large-calibre transcatheter aortic valve implantation access. PMID:23842759

Stretched size of atrial septal defect predicted by intracardiac echocardiography.

PubMed

Lin, Ming-Chih; Fu, Yun-Ching; Jan, Sheng-Ling; Ho, Chi-Lin; Hwang, Betau

2010-01-01

The stretched size of an atrial septal defect (ASD) is important for device selection during transcatheter closure. However, balloon sizing carries potential risks such as hypotension, bradycardia, or laceration of the atrial septum. The aim of the present study was to investigate the accuracy of the predicted stretched size of ASD by intracardiac echocardiography (ICE). From December 2004 to November 2007, 136 consecutive patients with single secundum type ASD undergoing transcatheter closure of their defect using the Amplatzer septal occluder under ICE guidance were enrolled for analysis. There were 43 males and 93 females. The age ranged from 2.2 to 79.1 years with a median age of 13.4 years. The body weight ranged from 12.1 to 93.2 kg with a median body weight of 45.8 kg. The stretched size of ASD measured by a sizing plate was considered as the standard. ASD sizes measured by ICE in bicaval and short-axis views predicted the stretched size by formulae derived from linear regressions. The predicted stretched sizes obtained using 2 formulae, 1.34 x radicalbicaval xshort axis (formula 1) and 1.22 x larger diameter (formula 2), exhibited good agreement with the standard stretched size with Kappa values of 0.91 and 0.90, respectively. The accuracy rate of predicted stretched sizes within 2 mm, 3 mm, and 4 mm range of the standard size were 32.8%, 45.4%, and 57.7% (formula 1) and 33.1%, 50%, and 63.2% (formula 2). The stretched size of ASD predicted by ICE exhibited good agreement with the standard stretched size. This prediction provides helpful information, especially if balloon sizing cannot be adequately performed.

Vascular closure devices in stroke patients receiving tissue plasminogen activator: A retrospective analysis from an academic tertiary medical center and a teaching community hospital stroke database.

PubMed

Patil, Mangaladevi S; Jayaraman, Mahesh V; Ahn, Sun H

2017-06-01

To determine the safety and effectiveness of vascular closure devices in prevention of access site complications in acute stroke patient receiving intravenous (IV) and/or intra-arterial (IA) IV tissue plasminogen activator (tPA). All patients with acute stroke onset treated with IV and/or IA tPA closed with vascular closure device and adult age (>18 years) were identified from an academic tertiary medical center and a teaching community hospital stroke database for 9 years (from March 2005 to June 2014). A total of 69 patients were included in the study. The mean age was 68.86±16.70 years and 49.2% female. All accesses were under fluoroscopic guidance into the right common femoral artery. We observed a 5.8% complication rate in patients receiving IV and/or IA tPA closed with vascular closure device. Access site complications included 3 cases of hematoma and 1 case of residual oozing. One patient required transfusion due to access site hematoma. Three patients were on aspirin and heparin and 1 was on no prior anticoagulation. Vascular closure device access site hemorrhagic complication rate in those receiving IV and/or IA tPA is low and similar to reported rates in those not receiving thrombolytic therapy. Vascular closure device use in patients receiving thrombolytic therapy is safe and effectively achieves hemostasis. Copyright © 2017 Elsevier B.V. All rights reserved.

Transcatheter closure of patent ductus arteriosus in children weighing 10 kg or less: Initial experience at Sohag University Hospital.

PubMed

Ali, Safaa; El Sisi, Amel

2016-04-01

To assess the challenges, feasibility, and efficacy of device closure of patent ductus arteriosus (PDA) in small children weighing ⩽10 kg for different types of devices used in an initial experience at Sohag University hospital. Between March 2011 and September 2014, 91 patients with PDA underwent transcatheter closure in our institute, among whom 54 weighed ⩽10 kg. All of these patients underwent transcatheter closure of PDA using either a Cook Detachable Coil, PFM Nit-Occlud, or Amplatzer duct occluder. A retrospective review of the treatment results and adverse events was performed. Successful device placement was achieved in 53/54 small children (98.1%). The median minimum PDA diameter was 2.4 mm [interquartile range (IQR, 1.8-3.5 mm), median weight 8 kg (IQR, 7-10 kg), and median age 10 months (IQR, 8-17 months)]. Mild aortic obstruction occurred in one case (1.9%), as the device became displaced towards the aorta after release. The device embolized in one case (1.9%) and no retrieval attempt was made. Five cases (9.3%) had minor vascular complications. With the current availability of devices for PDA closure, transcatheter closure of PDA is considered safe and efficacious in small children weighing ⩽10 kg with good mid-term outcome. The procedure had a low rate of high-severity adverse events even with the initial experience of the catheterization laboratory.

Closure of Patent Foramen Ovale versus Medical Therapy after Cryptogenic Stroke: Meta-Analysis of Five Randomized Controlled Trials with 3440 Patients

PubMed Central

Sá, Michel Pompeu Barros Oliveira; de Oliveira Neto, Luiz de Albuquerque Pereira; do Nascimento, Gabriella Caroline Sales; Vieira, Erik Everton da Silva; Martins, Gabriel Lopes; Rodrigues, Karine Coelho; Nascimento, Giulia Cioffi; de Menezes, Alexandre Motta; Lins, Ricardo Felipe de Albuquerque; Silva, Frederico Pires Vasconcelos; Lima, Ricardo Carvalho

2018-01-01

Objective We aimed to determine whether patent foramen ovale closure reduces the risk of stroke, also assessing some safety outcomes. Introduction The clinical benefit of closing a patent foramen ovale after a cryptogenic stroke has been an open question for several decades, so that it is necessary to review the current state of published medical data in this regard. Methods MEDLINE, EMBASE, CENTRAL/CCTR, SciELO, LI-LACS, Google Scholar and reference lists of relevant articles were searched for randomized controlled trials that reported any of the following outcomes: stroke, death, major bleeding or atrial fibrillation. Five studies fulfilled our eligibility criteria and included 3440 patients (1829 for patent foramen ovale closure and 1611 for medical therapy). Results The risk ratio (RR) for stroke in the "device closure" group compared with the "medical therapy" showed a statistically significant difference between the groups, favouring the "device closure" group (RR 0.400; 95% CI 0.183-0.873, P=0.021). There was no statistically significant difference between the groups regarding the safety outcomes death and major bleeding, but we observed an increase in the risk of atrial fibrillation in the "device closure group (RR 4.000; 95% CI 2.262-7.092, P<0.001). We also observed that the larger the proportion of effective closure, the lower the risk of stroke. Conclusion This meta-analysis found that stroke rates are lower with percutaneously implanted device closure than with medical therapy alone, being these rates modulated by the rates of effective closure. PMID:29617507

Remotely operated pipe connector

DOEpatents

Josefiak, Leonard J.; Cramer, Charles E.

1988-01-01

An apparatus for remotely assembling and disassembling a Graylock type coctor between a pipe and a closure for the pipe includes a base and a receptacle on the base for the closure. The pipe is moved into position vertically above the closure by a suitable positioning device such that the flange on the pipe is immediately adjacent and concentric with the flange on the closure. A moving device then moves two semicircular collars from a position free of the closure to a position such that the interior cam groove of each collar contacts the two flanges. Finally, a tensioning device automatically allows remote tightening and loosening of a nut and bolt assembly on each side of the collar to cause a seal ring located between the flanges to be compressed and to seal the closure. Release of the pipe and the connector is accomplished in the reverse order. Preferably, the nut and bolt assembly includes an elongate shaft portion on which a removable sleeve is located.

AMPLATZER versus Figulla occluder for transcatheter patent foramen ovale closure.

PubMed

Trabattoni, Daniela; Gaspardone, Achille; Sgueglia, Gregory A; Fabbiocchi, Franco; Gioffrè, Gaetano; Montorsi, Piero; Calligaris, Giuseppe; Iamele, Maria; De Santis, Antonella; Bartorelli, Antonio L

2017-04-20

The aim of this observational study was to compare acute and 12-month results of percutaneous closure of patent foramen ovale (PFO) with two occluder devices. Between June 2007 and October 2014, 406 consecutive patients (48.1±13.3 years, 243 women) underwent percutaneous PFO closure with either the AMPLATZER (n=179) or the Figulla (n=227) device after a stroke or a transient ischaemic attack ascribed to the PFO. A right-to-left shunt grade >1 was previously detected in all patients and atrial septal aneurysm was present in 111 (27.5%) patients. Patients were followed up with a contrast transthoracic echocardiogram and clinically at 24 hours, six months, and 12 months after the procedure. A high procedural success was observed in both groups. Despite a trend towards a higher incidence of acute residual shunt immediately after device deployment among Figulla occluder patients, a residual grade ≥2 right-to-left shunt was observed in 4.5% of patients, independently of the device used for PFO closure. The only difference reported after Figulla device implantation was a lower rate of supraventricular arrhythmias (9% vs. 17%, p=0.02). According to this two-centre study, PFO closure appears safe and effective with the Figulla occluder as well as with the AMPLATZER device.

CIRSE Vascular Closure Device Registry

DOE Office of Scientific and Technical Information (OSTI.GOV)

Reekers, Jim A., E-mail: j.a.reekers@amc.uva.nl; Mueller-Huelsbeck, Stefan; Libicher, Martin

2011-02-15

Purpose: Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology. Methods: The CIRSE registry of closure devices with an anchor and a plug started in January 2009 and ended in August 2009. A total of 1,107 patients were included in the registry. Results: Deployment success was 97.2%. Deployment failure specified to access type was 8.8% [95% confidence interval (95% CI) 5.0-14.5] for antegrade access and 1.8% (95% CI 1.1-2.9) for retrograde access (Pmore » = 0.001). There was no difference in deployment failure related to local PVD at the access site. Calcification was a reason for deployment failure in only <0.5% of patients. Postdeployment bleeding occurred in 6.4%, and most these (51.5%) could be managed with light manual compression. During follow-up, other device-related complications were reported in 1.3%: seven false aneurysms, three hematoma >5.9 cm, and two vessel occlusions. Conclusion: The conclusion of this registry of closure devices with an anchor and a plug is that the use of this device in interventional radiology procedures is safe, with a low incidence of serious access site complications. There seems to be no difference in complications between antegrade and retrograde access and other parameters.« less

CIRSE Vascular Closure Device Registry

PubMed Central

Müller-Hülsbeck, Stefan; Libicher, Martin; Atar, Eli; Trentmann, Jens; Goffette, Pierre; Borggrefe, Jan; Zeleňák, Kamil; Hooijboer, Pieter; Belli, Anna-Maria

2010-01-01

Purpose Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology. Methods The CIRSE registry of closure devices with an anchor and a plug started in January 2009 and ended in August 2009. A total of 1,107 patients were included in the registry. Results Deployment success was 97.2%. Deployment failure specified to access type was 8.8% [95% confidence interval (95% CI) 5.0–14.5] for antegrade access and 1.8% (95% CI 1.1–2.9) for retrograde access (P = 0.001). There was no difference in deployment failure related to local PVD at the access site. Calcification was a reason for deployment failure in only <0.5% of patients. Postdeployment bleeding occurred in 6.4%, and most these (51.5%) could be managed with light manual compression. During follow-up, other device-related complications were reported in 1.3%: seven false aneurysms, three hematoma >5.9 cm, and two vessel occlusions. Conclusion The conclusion of this registry of closure devices with an anchor and a plug is that the use of this device in interventional radiology procedures is safe, with a low incidence of serious access site complications. There seems to be no difference in complications between antegrade and retrograde access and other parameters. PMID:20981425

9 CFR 318.301 - Containers and closures.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Section 318.301 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... examinations for rigid containers (cans)—(1) Visual examinations. A closure technician shall visually examine... container shall be examined for product leakage or obvious defects. A visual examination shall be performed...

Neural Tube Defects

PubMed Central

Greene, Nicholas D.E.; Copp, Andrew J.

2015-01-01

Neural tube defects (NTDs), including spina bifida and anencephaly, are severe birth defects of the central nervous system that originate during embryonic development when the neural tube fails to close completely. Human NTDs are multifactorial, with contributions from both genetic and environmental factors. The genetic basis is not yet well understood, but several nongenetic risk factors have been identified as have possibilities for prevention by maternal folic acid supplementation. Mechanisms underlying neural tube closure and NTDs may be informed by experimental models, which have revealed numerous genes whose abnormal function causes NTDs and have provided details of critical cellular and morphological events whose regulation is essential for closure. Such models also provide an opportunity to investigate potential risk factors and to develop novel preventive therapies. PMID:25032496

Safety of Percutaneous Patent Ductus Arteriosus Closure: An Unselected Multicenter Population Experience

PubMed Central

El‐Said, Howaida G.; Bratincsak, Andras; Foerster, Susan R.; Murphy, Joshua J.; Vincent, Julie; Holzer, Ralf; Porras, Diego; Moore, John; Bergersen, Lisa

2013-01-01

Background The technique and safety of transcatheter patent ductus arteriosus (PDA) closure have evolved during the past 20 years. We sought to report a multicenter experience of PDA closure with a focus on the rate of adverse events (AE) and a review of institutional practice differences. Methods and Results Outcome data on transcatheter PDA closure were collected at 8 centers prospectively using a multicenter registry (Congenital Cardiac Catheterization Project on Outcome Registry). Between February 2007 and June 2010, 496 PDA closures were recorded using a device in 338 (68%) or coils in 158 (32%). Most patients had an isolated PDA (90%). Fifty percent of patients were between 6 months and 3 years old, with only 40 patients (8%) <6 months old. Median minimum PDA diameter was 2.5 mm (range 1 to 12 mm; IQR 2 to 3 mm) for device closure and 1 mm (range 0.5 to 6 mm; IQR 1 to 2 mm) for coil closure (P<0.001). A device rather than coil was used in patients <3 years, weight <11 kg, and with a PDA minimum diameter >2 mm (all P<0.001). Three of 8 centers exclusively used a device for PDAs with a diameter >1.5 mm. In 9% of cases (n=46), an AE occurred; however, only 11 (2%) were classified as high severity. Younger age was associated with a higher AE rate. Coil‐related AEs were more common than device‐related AEs (10% versus 2%, P<0.001). Conclusions PDA closure in the present era has a very low rate of complications, although these are higher in younger children. Technical intervention‐related events were more common in coil procedures compared with device procedures. For PDAs ≤2.5 mm in diameter, institutional differences in preference for device versus coil exist. PMID:24284214

Left Atrial Appendage Closure for Stroke Prevention: Devices, Techniques, and Efficacy.

PubMed

Iskandar, Sandia; Vacek, James; Lavu, Madhav; Lakkireddy, Dhanunjaya

2016-05-01

Left atrial appendage closure can be performed either surgically or percutaneously. Surgical approaches include direct suture, excision and suture, stapling, and clipping. Percutaneous approaches include endocardial, epicardial, and hybrid endocardial-epicardial techniques. Left atrial appendage anatomy is highly variable and complex; therefore, preprocedural imaging is crucial to determine device selection and sizing, which contribute to procedural success and reduction of complications. Currently, the WATCHMAN is the only device that is approved for left atrial appendage closure in the United States. Copyright © 2016 Elsevier Inc. All rights reserved.

A New Coated Nitinol Occluder for Transcatheter Closure of Ventricular Septal Defects in a Canine Model

PubMed Central

Zhou, Yong; Chen, Feng; Huang, Xinmiao; Zhao, Xianxian; Wu, Hong; Bai, Yuan; Qin, Yongwen

2013-01-01

Aims. This study evaluated feasibility and safety of implanting the polyester-coated nitinol ventricular septal defect occluder (pcVSDO) in the canine model. Methods and Results. VSD models were successfully established by transseptal ventricular septal puncture via the right jugular vein in 15 out of 18 canines. Two types of VSDOs were implanted, either with pcVSDOs (n = 8) as the new type occluder group or with the commercial ventricular septal defect occluders (VSDOs, n = 7, Shanghai Sharp Memory Alloy Co. Ltd.) as the control group. Sheath size was 10 French (10 Fr) in two groups. Then the general state of the canines was observed after implantation. ECG and TTE were performed, respectively, at 7, 30, 90 days of follow-up. The canines were sacrificed at these time points for pathological and scanning electron microscopy examination. The devices were successfully implanted in all 15 canines and were retrievable and repositionable. There was no thrombus formation on the device or occurrence of complete heart block. The pcVSDO surface implanted at day 7 was already covered with neotissue by gross examination, and it completed endothelialization at day 30, while the commercial VSDO was covered with the neotissue in 30th day and the complete endothelialization in 90th day. Conclusion. The study shows that pcVSDO is feasible and safe to close canine VSD model and has good biocompatibility and shorter time of endothelialization. PMID:24066289

Evaluation of bendectin embryotoxicity in nonhuman primates: I. Ventricular septal defects in prenatal macaques and baboon.

PubMed

Hendrickx, A G; Cukierski, M; Prahalada, S; Janos, G; Rowland, J

1985-10-01

Cynomolgus monkeys, rhesus monkeys and baboons were administered 10 to 40 times the human dose equivalent of Bendectin throughout the major period of organogenesis (22(+/-3)-50 days of gestation). In animals examined prenatally (100 +/- 2 days gestation) the total incidence of ventricular septal defects (VSD) was 40% in cynomolgus monkeys, 18% in rhesus monkeys, and 23% in baboons. The majority of VSD involved the muscular portion of the septum. No dose response was evident and there were no other cardiac or extracardiac defects found except for one baboon fetus with multiple defects. No defects were observed in cynomolgus monkeys administered Bendectin for 4-day periods between 22 and 41 days of gestation. There was no association of Bendectin treatment with any noncardiac defect. In cynomolgus and rhesus monkeys examined at term there was one mitral valve defect and no incidence of VSD. The increased incidence of VSD observed prenatally in all three species and the absence of defects in macaques at term suggests a delay in closure of the ventricular septum in treated animals. The Bendectin-treated monkey may be a suitable model for the study of the pathogenesis of VSD and the mechanism of spontaneous closure of the defect.

Sweat collection capsule

NASA Technical Reports Server (NTRS)

Greenleaf, J. E.; Delaplaine, R. W. (Inventor)

1980-01-01

A sweat collection capsule permitting quantitative collection of sweat is described. The device consists of a frame held immobile on the skin, a closure secured to the frame and absorbent material located next to the skin in a cavity formed by the frame and the closure. The absorbent material may be removed from the device by removing the closure from the frame while the frame is held immobile on the skin.

Retrograde transcatheter device closure of a complex paravalvular leak after bioprosthetic pulmonary valve replacement in a pediatric patient.

PubMed

Chikkabyrappa, Sathish; Mosca, Ralph S; McElhinney, Doff B

2016-06-01

We report a case of retrograde transcatheter device closure of a complex paravalvular leak (PVL) after bioprosthetic pulmonary valve replacement (PVR) in a 13-year-old patient with congenital pulmonary valve stenosis. There are prior reports of pulmonary PVL closure after PVR in adults (Seery and Slack, Congenit Heart Dis 2014;9:E19-F22), but indications for and technical considerations in PVL closure after bioprosthetic PVR, particularly in children, are not well defined. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

Angle closure glaucoma in congenital ectropion uvea.

PubMed

Wang, Grace M; Thuente, Daniel; Bohnsack, Brenda L

2018-06-01

Congenital ectropion uvea is a rare anomaly, which is associated with open, but dysplastic iridocorneal angles that cause childhood glaucoma. Herein, we present 3 cases of angle-closure glaucoma in children with congenital ectropion uvea. Three children were initially diagnosed with unilateral glaucoma secondary to congenital ectropion uvea at 7, 8 and 13 years of age. The three cases showed 360° of ectropion uvea and iris stromal atrophy in the affected eye. In one case, we have photographic documentation of progression to complete angle closure, which necessitated placement of a glaucoma drainage device 3 years after combined trabeculotomy and trabeculectomy. The 2 other cases, which presented as complete angle closure, also underwent glaucoma drainage device implantation. All three cases had early glaucoma drainage device encapsulation (within 4 months) and required additional surgery (cycloablation or trabeculectomy). Congenital ectropion uvea can be associated with angle-closure glaucoma, and placement of glaucoma drainage devices in all 3 of our cases showed early failure due to plate encapsulation. Glaucoma in congenital ectropion uvea requires attention to angle configuration and often requires multiple surgeries to obtain intraocular pressure control.

Modified Off-Midline Closure of Pilonidal Sinus Disease

PubMed Central

Saber, Aly

2014-01-01

Background: Numerous surgical procedures have been described for pilonidal sinus disease, but treatment failure and disease recurrence are frequent. Conventional off-midline flap closures have relatively favorable surgical outcomes, but relatively unfavorable cosmetic outcomes. Aim: The author reported outcomes of a new simplified off-midline technique for closure of the defect after complete excision of the sinus tracts. Patients and Methods: Two hundred patients of both sexes were enrolled for modified D-shaped excisions were used to include all sinuses and their ramifications, with a simplified procedure to close the defect. Results: The overall wound infection rate was 12%, (12.2% for males and 11.1% for females). Wound disruption was necessitating laying the whole wound open and management as open technique. The overall wound disruption rate was 6%, (6.1% for males and 5.5% for females) and the overall recurrence rate was 7%. Conclusion: Our simplified off-midline closure without flap appeared to be comparable to conventional off-midline closure with flap, in terms of wound infection, wound dehiscence, and recurrence. Advantages of the simplified procedure include potentially reduced surgery complexity, reduced surgery time, and improved cosmetic outcome. PMID:24926445

Transcatheter closure of patent ductus arteriosus in children weighing 10 kg or less: Initial experience at Sohag University Hospital

PubMed Central

Ali, Safaa; El Sisi, Amel

2015-01-01

Aim To assess the challenges, feasibility, and efficacy of device closure of patent ductus arteriosus (PDA) in small children weighing ⩽10 kg for different types of devices used in an initial experience at Sohag University hospital. Methods Between March 2011 and September 2014, 91 patients with PDA underwent transcatheter closure in our institute, among whom 54 weighed ⩽10 kg. All of these patients underwent transcatheter closure of PDA using either a Cook Detachable Coil, PFM Nit-Occlud, or Amplatzer duct occluder. A retrospective review of the treatment results and adverse events was performed. Results Successful device placement was achieved in 53/54 small children (98.1%). The median minimum PDA diameter was 2.4 mm [interquartile range (IQR, 1.8–3.5 mm), median weight 8 kg (IQR, 7–10 kg), and median age 10 months (IQR, 8–17 months)]. Mild aortic obstruction occurred in one case (1.9%), as the device became displaced towards the aorta after release. The device embolized in one case (1.9%) and no retrieval attempt was made. Five cases (9.3%) had minor vascular complications. Conclusion With the current availability of devices for PDA closure, transcatheter closure of PDA is considered safe and efficacious in small children weighing ⩽10 kg with good mid-term outcome. The procedure had a low rate of high-severity adverse events even with the initial experience of the catheterization laboratory. PMID:27053899

The "Skull Flap" a new conceived device for decompressive craniectomy experimental study on dogs to evaluate the safety and efficacy in reducing intracranial pressure and subsequent impact on brain perfusion.

PubMed

Salvatore, Chibbaro; Fabrice, Vallee; Marco, Marsella; Leonardo, Tigan; Thomas, Lilin; Benoit, Lecuelle; Bernard, George; Pierre, Kehrli; Eric, Vicaut; Paolo, Diemidio

2013-10-01

Decompressive craniectomy (DC) is a procedure performed increasingly often in current neurosurgical practice. Significant perioperative morbidity may be associated to this procedure because of the large skull defect; also, later closure of the skull defect (cranioplasty) may be associated to post-operative morbidity as much as any other reconstructive operation. The authors present a newly conceived/developed device: The "Skull Flap" (SF). This system, placed at the time of the craniectomy, offers the possibility to provide cranial reconstruction sparing patients a second operation. In other words, DC and cranioplasty essentially take place at the same time and in addition, patients retain their own bone flap. The current study conducted on animal models, represents the logical continuation of a prior recent study, realized on cadaver specimens, to assess the efficacy and safety of this recently developed device. This is an experimental pilot study on dogs to assess both safety and efficacy of the SF device. Two groups of experimental raised intracranial pressure animal models underwent DC; in the first group of dogs, the bone flap was left in raised position above the skull defect using the SF device; on the second group the flap was discarded. All dogs underwent transcranial Doppler (TCD) to assess brain perfusion. Head computed tomography (CT) scan to determine flap position was also obtained in the group in which the SF device was placed. SF has proved to be a strong fixation device that allows satisfactory brain decompression by keeping the bone flap elevated from the swollen brain; later on, the SF allows cranial reconstruction in a simple way without requiring a second staged operation. In addition, it is relevant to note that brain perfusion was measured and found to be better in the group receiving the SF (while the flap being in a raised as well as in its natural position) comparing to the other group. The SF device has proved to be very easy to place, well-adaptable to a different type of flaps and ultimately very effective in maintaining satisfactory brain decompression and later on, making easy bone flap repositioning after brain swelling has subsided.

Self-testing security sensor for monitoring closure of vault doors and the like

DOEpatents

Cawthorne, Duane C.

1997-05-27

A self-testing device is provided for a monitoring system for monitoring whether a closure member such as a door or window is closed. The monitoring system includes a switch unit mounted on the frame of the closure member being monitored and including magnetically biased switches connected in one or more electrical monitoring circuits, and a door magnet unit mounted on the closure member being monitored. The door magnet includes one or more permanent magnets that produce a magnetic field which, when the closure member is closed, cause said switches to assume a first state. When the closure member is opened, the switches switch to a second, alarm state. The self-testing device is electrically controllable from a remote location and produces a canceling or diverting magnetic field which simulates the effect of movement of the closure member from the closed position thereof without any actual movement of the member.

Self-testing security sensor for monitoring closure of vault doors and the like

DOEpatents

Cawthorne, D.C.

1997-05-27

A self-testing device is provided for a monitoring system for monitoring whether a closure member such as a door or window is closed. The monitoring system includes a switch unit mounted on the frame of the closure member being monitored and including magnetically biased switches connected in one or more electrical monitoring circuits, and a door magnet unit mounted on the closure member being monitored. The door magnet includes one or more permanent magnets that produce a magnetic field which, when the closure member is closed, cause said switches to assume a first state. When the closure member is opened, the switches switch to a second, alarm state. The self-testing device is electrically controllable from a remote location and produces a canceling or diverting magnetic field which simulates the effect of movement of the closure member from the closed position thereof without any actual movement of the member. 5 figs.

Early postoperative healing following buccal single flap approach to access intraosseous periodontal defects.

PubMed

Farina, Roberto; Simonelli, Anna; Rizzi, Alessandro; Pramstraller, Mattia; Cucchi, Alessandro; Trombelli, Leonardo

2013-07-01

This study aims to evaluate the early postoperative healing of papillary incision wounds and its association with (1) patient/site-related factors and technical (surgical) aspects as well as with (2) 6-month clinical outcomes following buccal single flap approach (SFA) in the treatment of intraosseous periodontal defects. Forty-three intraosseous defects in 35 patients were accessed with a buccal SFA alone or in combination with a reconstructive technology (graft, enamel matrix derivative (EMD), graft + EMD, or graft + membrane). Postoperative healing was evaluated at 2 weeks using the Early Wound-Healing Index (EHI). EHI ranged from score 1 (i.e., complete flap closure and optimal healing) to score 4 (i.e., loss of primary closure and partial tissue necrosis). SFA resulted in a complete wound closure at 2 weeks in the great majority of sites. A significantly more frequent presence of interdental contact point and interdental soft tissue crater, and narrower base of the interdental papilla were observed at sites with either EHI > 1 or EHI = 4 compared to sites with EHI = 1. No association between EHI and the 6-month clinical outcomes was observed. At 2 weeks, buccal SFA may result in highly predictable complete flap closure. Site-specific characteristics may influence the early postoperative healing of the papillary incision following SFA procedure. Two-week soft tissue healing, however, was not associated with the 6-month clinical outcomes.

Iniencephaly

MedlinePlus

... other neural tube defects. Information from the National Library of Medicine’s MedlinePlus Neural Tube Defects ... by improper closure of the neural tube (the part of a human embryo that becomes the brain and spinal cord) during fetal development. Iniencephaly is in the same family of neural ...

Short-Term Safety and Efficacy of Femoral Vascular Closure after Percutaneous Coronary Intervention with Combination of the Boomerang(TM) Device and Intravenous Protamine Sulfate.

PubMed

Chen, Ching-Pei; Huang, Huang-Kai; Hsia, Chien-Hsun; Chang, Yung-Ming; Lin, Lee-Shin; Lee, Cheng-Liang

2013-11-01

The Cardiva Boomerang(TM) is a device used to perform femoral vascular closure. It facilitates passive hemostasis at the arteriotomy site, leaving no residual foreign body. We performed a controlled, randomized study of 60 patients undergoing percutaneous coronary intervention. Patients were randomized into two groups (30 per group) to undergo vascular closure with the Boomerang(TM) or the Perclose(TM) suture-based device after the intravenous administration of protamine sulfate. We compared overall success rates, patient-reported pain, length of time to achieve hemostasis and mobilization of the patient, and the frequency of complications in the two groups. Overall success rates using the Boomerang(TM) and Perclose(TM) devices were similarly high, at 93% and 97%, respectively. The Boomerang(TM) was significantly quicker to deploy than the PercloseTM, device deployment time, median (Q1-Q3), [2.00 (1.33-2.75) vs. 3.84 (2.75-4.38) mins, p < 0.001)]. The pain score was significantly lower in the Boomerang(TM) group (1.1 ± 1.7 vs. 6.4 ± 2.9, p < 0.001). The time the device remained in the artery and manual compression time were significantly longer with the Boomerang(TM) (p < 0.001), as well as the time taken to achieve hemostasis and time to ambulation. There were no major complications in either group and no significant differences between the groups in the frequency of minor complications. We conclude that when used in combination with intravenous protamine sulfate, the Boomerang(TM) device is as safe and effective as the Perclose(TM) device for femoral vascular closure, but quicker to deploy and less painful to patients. Boomerang; Percutaneous intervention; Vascular closure device.

Endonasal Suturing of Nasoseptal Flap to Nasopharyngeal Fascia Using the V-Loc™ Wound Closure Device: 2-Dimensional Operative Video.

PubMed

Zwagerman, Nathan T; Geltzeiler, Mathew N; Wang, Eric W; Fernandez-Miranda, Juan C; Snyderman, Carl H; Gardner, Paul A

2018-05-30

We present a case of cerebrospinal fluid (CSF) leak after endoscopic endonasal resection of a large clival chordoma in an obese patient. The leak was at the lower reconstruction at the craniocervical junction and had failed repositioning. Using the V-Loc™ wound closure device (Covidien, New Haven, Connecticut) to suture the nasoseptal flap to the nasopharyngeal fascia, a water-tight seal was created and, along with a lumbar drain, the patient healed successfully.CSF leak after an endoscopic endonasal approach (EEA) to intradural pathologies remains one of the more common complications.1-4 Various closure techniques have been developed5-8 with success in mitigating this risk, but all have their limitations and rely on multiple layers including vascularized flaps like the nasoseptal flap.9-11 Endonasal suturing of graft materials offers the advantage of creating a water-tight seal. We present the use of the V-Loc™ wound closure device (Covidien) to successfully seal a postoperative CSF leak. The absorbable V-Loc™ wound closure device does not require the surgeon to tie knots, which is the most challenging step in a deep, 2-dimensional corridor. The suture is barbed and is anchored by threading the needle through a prefabricated loop at the end of the suture which locks in place. Each throw of the suture through tissue maintains the suture line as the barbs catch the tissue and prevent retraction. After successful closure, the needle can simply be cut off.The V-Loc™ wound closure device (Covidien) is a safe and effective adjunct to reconstruction after endoscopic endonasal skull base surgery as it provides an option for graft/flap suturing.A written release from the patient whose name or likeness is submitted as part of this Work is on file.

Greater Success of Primary Fascial Closure of the Open Abdomen: A Retrospective Study Analyzing Applied Surgical Techniques, Success of Fascial Closure, and Variables Affecting the Results.

PubMed

Kääriäinen, M; Kuuskeri, M; Helminen, M; Kuokkanen, H

2017-06-01

The open abdomen technique is a standard procedure in the treatment of intra-abdominal catastrophe. Achieving primary abdominal closure within the initial hospitalization is a main objective. This study aimed to analyze the success of closure rate and the effect of negative pressure wound therapy, mesh-mediated medial traction, and component separation on the results. We present the treatment algorithm used in our institution in open abdomen situations based on these findings. Open abdomen patients (n = 61) treated in Tampere University Hospital from May 2005 until October 2013 were included in the study. Patient characteristics, treatment prior to closure, closure technique, and results were retrospectively collected and analyzed. The first group included patients in whom direct or bridged fascial closure was achieved, and the second group included those in whom only the skin was closed or a free skin graft was used. Background variables and variables related to surgery were compared between groups. Most of the open abdomen patients (72.1%) underwent fascial defect repair during the primary hospitalization, and 70.5% of them underwent direct fascial closure. Negative pressure wound therapy was used as a temporary closure method for 86.9% of the patients. Negative pressure wound therapy combined with mesh-mediated medial traction resulted in the shortest open abdomen time (p = 0.039) and the highest fascial repair rate (p = 0.000) compared to negative pressure wound therapy only or no negative pressure wound therapy. The component separation technique was used for 11 patients; direct fascial closure was achieved in 5 and fascial repair by bridging the defect with mesh was achieved in 6. A total of 8 of 37 (21.6%) patients with mesh repair had a mesh infection. The negative pressure wound therapy combined with mesh-mediated medial traction promotes definitive fascial closure with a high closure rate and a shortened open abdomen time. The component separation technique can be used to facilitate fascial repair but it does not guarantee direct fascial closure in open abdomen patients.

Prediction of left ventricular dysfunction after device closure of patent ductus arteriosus: proposal for a new functional classification.

PubMed

Kiran, Viralam S; Tiwari, Ashish

2018-04-06

The aims of this study were to determine the incidence and correlates of left ventricular (LV) dysfunction amongst percutaneous patent ductus arteriosus (PDA) device closure patients, and to propose an indexed parameter for predicting LV dysfunction. In a retrospective cross-sectional analysis of 30 months duration, 447 patients who underwent PDA device closure were studied. The diameter of the PDA at the pulmonary artery end was measured in the angiograms in all patients and was indexed for their body surface area. The indexed PDA size was categorised into group A (1-2.9 mm/m², 35/447), B (3-5.9 mm/m², 254/447), C (6-8.9 mm/m², 66/447) and D (>9 mm/m², 35/447). Systolic LV function was evaluated using echocardiography at frequent intervals. Overall, 62.63% of the patients were female (280/447). At baseline, all 447 patients had normal LV function. LV dysfunction was seen in 102/447 (22.8%) patients with 2.8% in category A (1/35), 10.6% in category B (27/254), 34.1% in category C (42/123) and 91.4% in category D (32/35) after PDA device closure. Correlation of indexed PDA size and LV dysfunction was statistically significant (p<0.05). Accurate prediction of LV dysfunction is important in risk stratification, ICU management and counselling in PDA device closures. Indexed PDA size correlates well with post-procedural LV dysfunction. The authors propose a new classification of PDA utilising this accurate, reproducible and easy to perform parameter, which does not involve any extra cost, for risk stratification and early management in device closure of PDA.

Management of Complex Abdominal Wall Defects Associated with Penetrating Abdominal Trauma

DTIC Science & Technology

2014-05-09

recruitment): a new method of wound closure. Ann Plast Surg 2005;55:660–4. 8 Ramirez OM, Ruas E, Dellon AL. ‘Components separation’ method for closure of...patients with open abdomens closed by either permanent mesh, vicryl mesh or a modification of Ramirez ’ original method of components separation. These

Transcatheter closure of the left atrial appendage: initial experience with the WATCHMAN device

PubMed Central

Ding, Jiandong; Zhu, Jian; Lu, Jing; Ding, Xiuxia; Zhang, Xiaoli; Lu, Wenbin; Ao, Mingqiang; Ma, Genshan

2015-01-01

Background: Atrial fibrillation (AF) is the most commonly encountered clinical arrhythmia, accounting for approximately one third of hospitalizations for cardiac rhythm disturbance. In patients with non-valvular AF, approximately 90% of thrombi are thought to arise from the left atrial appendage (LAA). Anticoagulation with warfarin has been the mainstay of therapy to reduce stroke risk in these patients; however, it is not without its complications including bleeding and drug interactions. Percutaneous left atrial appendage closure can be an alternative to warfarin treatment in patients with AF at high risk for thromboembolic events and/or bleeding complications. Methods: Patients with atrial fibrillation and CHADSVASc score ≥ 2, not eligible for anticoagulation, were submitted to left atrial appendage closure using the WATCHMAN device. The procedure was performed under general anaesthesia, and was guided by fluoroscopy and transoesophageal echocardiography. Results: Percutaneous LAA closure with the WATCHMAN device was performed in all patients. At 45-day follow-up no recurrent major adverse events and especially no thromboembolic events occurred. Conclusions: Transcatheter closure of the LAA with the WATCHMAN device is generally safe and feasible. Long-term follow-up will further reveal the risk and benefits of this therapy. PMID:26629008

Transcatheter closure of ventricular septal defects with nitinol wire occluders of type patent ductus arteriosus.

PubMed

Wierzyk, Arkadiusz; Szkutnik, Małgorzata; Fiszer, Roland; Banaszak, Paweł; Pawlak, Szymon; Białkowski, Jacek

2014-01-01

Ventricular septal defects closure (VSD) depending on the anatomy and clinical setting can be performed surgically or by a hybrid and transcatheter approach. Two cases of children with VSD will be presented. Patients' defects were closed with various types of occluders made of nitinol wire mesh occluder, patent ductus arteriosus (PDA) type. The first case was a 2.5-year-old boy after cardiosurgical correction of tetralogy of Fallot (TOF). After the procedure, a significant haemodynamic residual VSD was observed, which was not successfully closed during the subsequent reoperation. Despite pharmacological treatment, symptoms of heart failure were observed in this patient. In echocardiographic images the residual VSD was presented as a tunnel-like dissection of the ventricular septum (length 6 mm and diameter 3.4 mm). The defect was closed via arterial access with an Amplatzer Duct Occluder II (ADO II). The procedure was successfully performed without any medical complications. In this child, a significant shunt reduction and a noticeable improvement in the patient's clinical status and diminished symptoms of heart failure were noticed. The second patient was a 4-year-old girl suffering from a multi-perforated perimembranous VSD accompanied by a ventricular septal defect with aneurysm. The defect was closed by a venous approach with a PDA Cardio-O-Fix occluder (very similar to ADO I). No short-term or long-term complications were visible during or after the procedure. Only a mild residual shunt through the VSD was observed 6 months afterwards. Transcatheter VSD closure with a proper morphology, with occluders of type Amplatzer Duct Occluder ADO I or ADO II, constitutes a safe and effective therapeutic alternative.

Ventricular septal defect closure in a patient with achondroplasia.

PubMed

Nakanishi, Keisuke; Kawasaki, Shiori; Amano, Atsushi

2017-01-01

Achondroplasia with co-morbid CHD is rare, as are reports of surgical treatment for such patients. We present the case of a 13-year-old girl with achondroplasia and ventricular septal defect. Her ventricular septal defect was surgically repaired focussing on the cardiopulmonary bypass flow, healing of the sternum, and her frail neck cartilage. The surgery and recovery were without complications.

Importance of transcatheter closure test for giant ventricular septal defect associated with pulmonary hypertension: a case with successful surgical repair of the defect.

PubMed

Shang, Xiaoke; Lu, Rong; Dong, Nianguo

2018-06-20

This is the first attempt to use a temporary occluder to close a giant perimembranous ventricular septal defect (32 mm), which obtains clinical evidence of good haemodynamics in patients with severe pulmonary hypertension. This may provide an alternative assessment to guide cardiac surgeons in determining a definitive treatment.

Transseptal Guidewire Stabilization for Device Closure of a Large Pulmonary Arteriovenous Malformation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Joseph, George, E-mail: joseph59@gmail.com; Kunwar, Brajesh Kumar, E-mail: kunwar_brajesh@yahoo.com

A 46-year-old man presenting with massive hemoptysis was found to have a large pulmonary arteriovenous malformation (PAVM) in the right lung. Closure of the PAVM with an Amplatzer-type duct occluder was hampered by inability to advance the device delivery sheath into the PAVM due to vessel tortuosity and inadequate guidewire support. Atrial septal puncture was performed and a femorofemoral arteriovenous guidewire loop through the right pulmonary artery, PAVM, and left atrium was created. Traction on both ends of the guidewire loop allowed advancement of the device delivery sheath into the PAVM and successful completion of the procedure. Transseptal guidewire stabilizationmore » can be a valuable option during device closure of large PAVMs when advancement, stability, or kinking of the device delivery sheath is an issue.« less

Efficacy and Safety of Transthoracic Echocardiography Alone in Transcatheter Closure of Secundum-Type Atrial Septal Defects in Adults.

PubMed

Ding, Cheng; Chang, Jia-Kan; Lin, Chang-Chyi; Wu, Yong-Jian; Hsieh, Kai-Sheng

2016-04-01

On-site transthoracic echocardiography (TTE) to guide the transcutaneous closure of secundum-type atrial septal defects (ASDs) in the catheterization laboratory remains unclear, especially in adults. Between 2005 and 2012, a total of 82 adults underwent transcutaneous closure of ASDs. The initial 15 cases underwent the procedure with both on-site transesophageal echocardiography (TEE) and TTE monitoring. Since January 2008, a total of 67 patients underwent on-site TTE alone to guide the procedure. Among the 82 adult patients who underwent a transcutaneous closure of the secundum-type ASD procedure, all had successful closure of the defects, and no periprocedural adverse complications occurred. No statistical significance was observed in the successful complete shunt closure rate between the TEE plus TTE and TTE groups during sequential follow-up (postprocedure 24 hour [87% vs. 92%],1 month [93% vs. 95%], 3 month [93% vs. 97%], and 12 month [93% vs. 97%], P > 0.05, respectively) nor was a significant difference observed between the two groups, including decreased right ventricular dimension (29.5 ± 3.3 vs. 32.0 ± 4.9 mm, 26.5 ± 3.0 vs. 28.7 ± 4.6 mm, 26.2 ± 3.1 vs. 28.2 ± 4.8 mm, and 25.6 ± 2.8 vs. 27.7 ± 4.7 mm, P > 0.05, respectively) or increased left ventricular end-diastolic dimension (41.1 ± 2.0 vs. 42.6 ± 3.0 mm, 44.3 ± 2.7 vs. 45.5 ± 3.1 mm, 44.2 ± 2.8 vs. 45.4 ± 3.1 mm, 44.9 ± 2.7 vs. 45.8 ± 2.6 mm, P > 0.05, respectively) before the procedure, and at the 3-, 6-, and 12-month follow-up evaluations. This study showed that TTE guidance alone may be considered efficacious and safe as TEE during a transcutaneous ASD occlusion procedure in select adults. © 2015, Wiley Periodicals, Inc.

Left Atrial Appendage Eccentricity and Irregularity Are Associated With Residual Leaks After Percutaneous Closure.

PubMed

Rajwani, Adil; Shirazi, Masoumeh G; Disney, Patrick J S; Wong, Dennis T L; Teo, Karen S L; Delacroix, Sinny; Chokka, Ramesh G; Young, Glenn D; Worthley, Stephen G

2015-12-01

Predictors of residual leak following percutaneous LAA closure were evaluated. Left atrial appendage (LAA) closure aims to exclude this structure from the circulation, typically using a circular occluder. A noncircular orifice is frequently encountered however, and fibrous remodeling of the LAA in atrial fibrillation may restrict orifice deformation. Noncircularity may thus be implicated in the occurrence of residual leak despite an appropriately oversized device. Pre-procedural multislice computerized tomography was used to quantify LAA orifice eccentricity and irregularity. Univariate predictors of residual leak were identified with respect to the orifice, device, and relevant clinical variables, with the nature of any correlations then further evaluated. Eccentricity and irregularity indexes of the orifice in 31 individuals were correlated with residual leak even where the device was appropriately oversized. An eccentricity index of 0.15 predicted a residual leak with 85% sensitivity and 59% specificity. An irregularity index of 0.05 predicted a significant residual leak ≥3 mm with 100% sensitivity and 86% specificity. Orifice size, device size, degree of device oversize, left atrial volume, and pulmonary artery pressure were not predictors of residual leak. Eccentricity and irregularity of the LAA orifice are implicated in residual leak after percutaneous closure even where there is appropriate device over-size. Irregularity index in particular is a novel predictor of residual leak, supporting a closer consideration of orifice morphology before closure. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Efficacy and safety of non-suture dural closure using a novel dural substitute consisting of polyglycolic acid felt and fibrin glue to prevent cerebrospinal fluid leakage-A non-controlled, open-label, multicenter clinical trial.

PubMed

Terasaka, Shunsuke; Taoka, Toshiaki; Kuroda, Satoshi; Mikuni, Nobutaka; Nishi, Toru; Nakase, Hiroyuki; Fujii, Yukihiko; Hayashi, Yasuhiko; Murata, Jun-Ichi; Kikuta, Ken-Ichiro; Kuroiwa, Toshihiko; Shimokawa, Sachie; Houkin, Kiyohiro

2017-05-01

The objective of this study is to evaluate the efficacy and safety of non-suture dural closure using a novel dural substitute (GM111) consisting of polyglycolic acid felt with a fibrin-glue-coated area commensurate in size with the dural defect. This was a non-controlled, open-label, multicenter clinical trial. The efficacy evaluation endpoints were (1) GM111's intra-operative capability to close dural defects and (2) prevention of cerebrospinal fluid (CSF) leakage and subcutaneous CSF retention throughout the postoperative period (evaluated by diagnostic imaging). Patients meeting the following three preoperative and two intra-operative selection criteria were enrolled: (1) between 12 and <75 years of age; (2) the dura is surmised to be defective and in need of reconstruction; (3) informed written consent was obtained from the patient; (4) the surgical wound is class 1; and (5) the size of duraplasty is ≥0.2 cm 2 to <100 cm 2 . Sixty patients were enrolled. The craniotomy site was supratentorial in 77.2%, infratentorial in 12.3% and sellar in 10.5%. The GM111 prosthesis size ranged from 0.24 to 42 cm 2 . To evaluate the efficacy, intra-operative closure was confirmed by Valsalva's maneuver, water infusion, etc., in all patients. CSF leakage and subcutaneous CSF retention throughout the postoperative period were found in four patients. Adverse events for which a causal relationship with GM111 could not be ruled out occurred in 8.8% of the patients. There were no instances of postoperative infection due to GM111. GM111 showed good closure capability and safety when used for non-suture dural closure.

Use of percutaneous closure devices in the removal of central venous catheters from inadvertent arterial catheterizations.

PubMed

Guimaraes, M; Uflacker, R; Schonholz, C; Hannegan, C; Selby, B

2008-06-01

Although rare, misplacement of central venous catheters in supra-aortic arteries is potentially fatal. Five patients had safe catheters removal using percutaneous closure devices. Three patients were coagulopathic, 3 under intensive care and 1 in immediate postoperative limb amputation. Patients were treated successfully, with immediate hemostasis and without complications in a mean follow-up of 12.5 months. Although the number of patients is small, the closure devices proved to be safe. This is a minimally invasive alternative technique in the management of large bore catheters removed from non-compressible puncture sites such as subclavian and brachiocephalic arteries.

Repairing Fetal Membranes with a Self-adhesive Ultrathin Polymeric Film: Evaluation in Mid-gestational Rabbit Model.

PubMed

Pensabene, Virginia; Patel, Premal P; Williams, Phillip; Cooper, Trisha L; Kirkbride, Kellye C; Giorgio, Todd D; Tulipan, Noel B

2015-08-01

Preterm premature rupture of membranes causes 40% of all preterm births, affecting 150000 women each year in the United States. Prenatal diagnostic procedures and surgical interventions increase incidence of adverse events, leading to iatrogenic membrane rupture after a fetoscopic procedure in 45% of cases. We propose an ultrathin, self-adherent, poly-L-lactic acid patch ("nanofilm") as a reparative wound closure after endoscopic/fetoscopic procedures. These nanofilms are compatible with application in wet conditions and with minimally invasive instrumentation. Ex vivo studies to evaluate the nanofilm were conducted using human chorion-amnion (CA) membranes. A custom-built inflation device was used for mechanical characterization of CA membranes and for assessment of nanofilm adhesion and sealing of membrane defects up to 3 mm in size. These ex vivo tests demonstrated the ability of the nanofilm to seal human CA defects ranging in size from 1 to 3 mm in diameter. In vivo survival studies were conducted in 25 mid-gestational rabbits, defects were created by perforating the uterus and the CA membranes and subsequently using the nanofilm to seal these wounds. These in vivo studies confirmed the successful sealing of defects smaller than 3 mm observed ex vivo. Histological analysis of whole harvested uteri 7 days after surgery showed intact uterine walls in 59% of the nanofilm repaired fetuses, along with increased uterine size and intrauterine development in 63% of the cases. In summary, we have developed an ultrathin, self-adhesive nanofilm for repair of uterine membrane defects.

Off-pump repair of a post-infarct ventricular septal defect: the 'Hamburger procedure'

PubMed Central

Barker, Thomas A; Ng, Alexander; Morgan, Ian S

2006-01-01

We report a novel off-pump technique for the surgical closure of post-infarct ventricular septal defects (VSDs). The case report describes the peri-operative management of a 76 year old lady who underwent the 'Hamburger procedure' for closure of her apical VSD. Refractory cardiogenic shock meant that traditional patch repairs requiring cardiopulmonary bypass would be poorly tolerated. We show that echocardiography guided off-pump posterior-anterior septal plication is a safe, effective method for closing post-infarct VSDs in unstable patients. More experience is required to ascertain whether this technique will become an accepted alternative to patch repairs. PMID:16722552

The importance of localizing pulmonary veins in atrial septal defect closure!

PubMed Central

2011-01-01

An 8-year-old girl was admitted for a simple closure of echocardiographically diagnosed Atrial Septal Defect (ASD). During the operation the right pulmonary veins orifices were not detected in the left atrium and attempt to localize them led to the discovery of three additional anomalies, namely Interrupted Inferior Vena Cava (IIVC), Scimitar syndrome, and systemic arterial supply of the lung. Postoperatively these finding were confirmed by CT angiography. This case report emphasizes the need for adequate preoperative diagnosis and presents a very rare constellation of four congenital anomalies that to the best of our knowledge is not reported before. PMID:21450090

Suicide right ventricle after lung transplantation for pulmonary vascular disease.

PubMed

Gangahanumaiah, Shivanand; Scarr, Bronwyn C; Buckland, Mark R; Pilcher, David V; Paraskeva, Miranda A; McGiffin, David C

2018-06-19

A 27-year-old female with Eisenmenger's syndrome underwent closure of a patent ductus arteriosus, closure of a perimembranous ventricular septal defect and mid muscular defect and bilateral lung transplantation. Her immediate postoperative course was complicated by severe right ventricular outflow tract (RVOT) obstruction resulting in hemodynamic collapse, a condition described as suicide right ventricle. The patient was placed on central Veno-Arterial Extra-Corporeal Membrane Oxygenation as a bridge to the relief of RVOT obstruction which included a right ventricular outflow muscle resection and a right ventricle outflow tract patch. The patient made an uneventful recovery. © 2018 Wiley Periodicals, Inc.

40 CFR 63.962 - Standards.

Code of Federal Regulations, 2011 CFR

2011-07-01

... shall control air emissions from the individual drain system using one or a combination of the following... closure device. (3) Junction box control requirements. Each junction box shall be equipped with controls as follows: (i) The junction box shall be equipped with a closure device (e.g., manhole cover, access...

40 CFR 63.962 - Standards.

Code of Federal Regulations, 2013 CFR

2013-07-01

... shall control air emissions from the individual drain system using one or a combination of the following... closure device. (3) Junction box control requirements. Each junction box shall be equipped with controls as follows: (i) The junction box shall be equipped with a closure device (e.g., manhole cover, access...

40 CFR 63.962 - Standards.

Code of Federal Regulations, 2012 CFR

2012-07-01

... shall control air emissions from the individual drain system using one or a combination of the following... closure device. (3) Junction box control requirements. Each junction box shall be equipped with controls as follows: (i) The junction box shall be equipped with a closure device (e.g., manhole cover, access...

40 CFR 63.962 - Standards.

Code of Federal Regulations, 2014 CFR

2014-07-01

... shall control air emissions from the individual drain system using one or a combination of the following... closure device. (3) Junction box control requirements. Each junction box shall be equipped with controls as follows: (i) The junction box shall be equipped with a closure device (e.g., manhole cover, access...

Robot-assisted surgery and incisional hernia: a comparative study of ergonomics in a training model.

PubMed

Sánchez, Alexis; Rodríguez, Omaira; Jara, Génesis; Sánchez, Renata; Vegas, Liumariel; Rosciano, José; Estrada, Luis

2018-01-04

Over the years, incisional hernia repair has evolved. Currently, primary closure of the defect before placing the mesh is a critical step in incisional hernia repair and minimally invasive surgery incorporation has an important role due to great advantages. Despite its benefits, laparoscopic closure with suture intracorporeal knotting is physically demanding and technically complex. Robotic technology provides an optimal three-dimensional view, maneuverability of the instruments but no study has assessed the impact of the DaVinci system in the ergonomics which is the objective in this study. Fourteen surgeons were able to achieve surgical repair of a defect in an incisional hernia inanimate model. The task was performed with conventional laparoscopy and robotic assistance. The mental effort was registered and physical disturbances were measured with the Local Experienced Discomfort scale. The subjects expressed discomfort mainly in the dominant side (p = 0.006). In the comparative analysis between the two approaches, upper limb less disturbance (p = 0.04) and lower mental effort (p = 0.001) were reported with robotic approach. Robotic assistance decreases mental and physical effort during the primary closure of a defect in an incisional hernia inanimate model.

The Effect of Levetiracetam on Closure of the Midline in Early Chicken Embryos.

PubMed

Ozgural, Onur; Armagan, Ercan; Bozkurt, Melih; Eroglu, Umit; Kahilogullari, Gokmen; Unlu, Agahan

2015-01-01

Genetic predisposition and some environmental factors play an important role in the development of neural tube defects. Levetiracetam is a new drug that has been approved in the treatment of partial seizures. We aimed in this study to determine the effect of levetiracetam on chick embryos. One hundred and sixty fertile non-pathogenic Super Nick eggs were incubated for 24 hours and were divided into four groups of 40 eggs each. Levetiracetam was administered via the sub-blastodermic route. The eggs were incubated for another 24 hours. All eggs were opened at the 48th hour, and the embryos were evaluated morphologically and histopathologically. The effects of levetiracetam on the embryo were correlated with the dose of levetiracetam. In the light of the results, it was determined that the use of increasing doses of levetiracetam led to defects of midline closure in early chicken embryos. Levetiracetam, a new antiepileptic drug that is effective especially on calcium ion concentration, leads to defects in midline closure in embryos in a dose-dependent manner. Further studies are needed to show the mechanism of embryonic damage and the mechanisms of its teratogenous effects associated with genetic and environmental factors.

Defect-driven flexochemical coupling in thin ferroelectric films

NASA Astrophysics Data System (ADS)

Eliseev, Eugene A.; Vorotiahin, Ivan S.; Fomichov, Yevhen M.; Glinchuk, Maya D.; Kalinin, Sergei V.; Genenko, Yuri A.; Morozovska, Anna N.

2018-01-01

Using the Landau-Ginzburg-Devonshire theory, we considered the impact of the flexoelectrochemical coupling on the size effects in polar properties and phase transitions of thin ferroelectric films with a layer of elastic defects. We investigated a typical case, when defects fill a thin layer below the top film surface with a constant concentration creating an additional gradient of elastic fields. The defective surface of the film is not covered with an electrode, but instead with an ultrathin layer of ambient screening charges, characterized by a surface screening length. Obtained results revealed an unexpectedly strong effect of the joint action of Vegard stresses and flexoelectric effect (shortly flexochemical coupling) on the ferroelectric transition temperature, distribution of the spontaneous polarization and elastic fields, domain wall structure and period in thin PbTi O3 films containing a layer of elastic defects. A nontrivial result is the persistence of ferroelectricity at film thicknesses below 4 nm, temperatures lower than 350 K, and relatively high surface screening length (˜0.1 nm ) . The origin of this phenomenon is the flexoelectric coupling leading to the rebuilding of the domain structure in the film (namely the cross-over from c-domain stripes to a-type closure domains) when its thickness decreases below 4 nm. The ferroelectricity persistence is facilitated by negative Vegard effect. For positive Vegard effect, thicker films exhibit the appearance of pronounced maxima on the thickness dependence of the transition temperature, whose position and height can be controlled by the defect type and concentration. The revealed features may have important implications for miniaturization of ferroelectric-based devices.

The Effect on Somatic Growth of Surgical and Catheter Treatment of Secundum Atrial Septal Defects.

PubMed

Chlebowski, Meghan M; Dai, Hongying; Kaine, Stephen F

2017-10-01

Historical studies suggest an association between atrial septal defect (ASD) and impaired growth with inconsistent improvement following closure. Limited data exist regarding the impact on growth in the era of transcatheter therapy. To evaluate the effect of closure on growth, we conducted a retrospective review of patients undergoing surgical or transcatheter closure during two time periods. Four hundred patients with isolated secundum ASD were divided into three cohorts: early surgical, contemporary surgical, and transcatheter. Data collected included demographics; height, weight, and body mass index (BMI) percentiles; catheterization hemodynamics; and co-morbidities. For all cohorts, there was no significant change in height or weight percentiles during two years after ASD closure. Age at repair was later for contemporary surgical and transcatheter cohorts (p < 0.0001). In the transcatheter cohort, mean Qp:Qs was 1.65 ± 0.54, but there was no correlation between greater Qp:Qs and decreased somatic growth. Subgroup analysis for patients with any initial growth percentile <5th percentile demonstrated a significant change in weight and BMI percentiles in the first two years after closure (p < 0.0004). The advent of transcatheter therapy shifted institutional practice to later age at repair for both surgical and transcatheter closure. There was no significant change in weight and height percentiles during two years after closure. Only patients with initial weight and BMI <5th percentile had improved growth after treatment. Concern for impaired growth should not generally be an indication for early ASD repair. However, early repair may be indicated in children with existing significant growth failure.

Decreased tricuspid regurgitation following percutaneous closure of congenital perimembranous ventricular septal defect: immediate and 6-month echocardiographic assessment.

PubMed

Xu, Xu-Dong; Liu, Su-Xuan; Bai, Yuan; Zhang, Min; Zhao, Xian-Xian; Qin, Yong-Wen

2015-09-01

As a common concomitant performance and the most frequent complications of transcatheter perimembranous ventricular septal defect (VSD) closure, tricuspid regurgitation (TR) has rarely been concerned. From January 2008 to December 2012, a total of 70 patients (men: 33, women: 37; mean age: 30.0 ± 17.1 years) with at least mild TR before VSD closure were examined in 508 consecutive congenital perimembranous VSD patients to investigate the outcomes of TR. After VSD closure, the jet area decreased from 3.4 ± 2.5 to 1.2 ± 2.5 cm(2) (p < 0.001); however, no significant decrease was found in 3 patients (mean age 59.7 ± 2.5 years) with severe TR (12.0 ± 1.2 versus 11.2 ± 3.2 cm(2), p = 0.668). Compared to the early outcome after VSD closure, the jet area detected by TTE at 6-month follow-up had further decreased (1.2 ± 2.5 versus 0.9 ± 2.2 cm(2), p < 0.001). In 6 patients, a slight residual shunt was detected immediately after VSD closure and diminished in 3 patients at 6-month follow-up. The hemolysis occurred in one of these six patients and recovered after 3 days. In conclusion, functional TR was ameliorated after percutaneous VSD closure, although persistent abundant TR was common in patients with severe TR before procedure.

Transcatheter closure of large patent ductus arteriosus using custom made devices.

PubMed

Rohit, Manoj Kumar; Gupta, Ankur

2017-05-01

There has been a paradigm shift in the transcatheter closure of patent ductus arteriosus (PDA) over the last 45 years. With the availability of various coils, plugs and occluders, PDA of almost all shapes and sizes are amenable to transcatheter closure. However, very large PDA diagnosed late in life are being referred for surgical closure in the absence of availability of large size devices, especially in developing countries. In this case series, we have described four patients with large PDA, three of which were closed by transcatheter custom made PDA occluders. © 2014 Wiley Periodicals, Inc. © 2014 Wiley Periodicals, Inc.

Preliminary experience with a new device for delayed sternal closure strategy in cardiac surgery.

PubMed

Santini, Francesco; Onorati, Francesco; Telesca, Mariassunta; Faggian, Giuseppe; Mazzucco, Alessandro

2012-06-01

Open chest management with delayed sternal closure (DSC) is a valuable strategy in the management of patients with postcardiotomy hemodynamic instability or severe coagulopathy. The conventional extemporized material available for off-label sternal stenting however may limit its efficacy. We evaluated outcomes of patients with refractory severe postcardiotomy cardiogenic shock (SPCCS) treated with DSC using a novel temporary sternal spreader (NTSS) which allows myocardial recovery by progressive controlled approximation of the sternal edges. Seven patients (4 male, mean age 66.5 ± 5 years) with refractory SPCCS showing acute hemodynamic instability at sternal closure, were implanted with the NTSS, consisting of stainless-steel branches linked to 2 diverging plates of polyether-ether ketone, whose progressive opening/closing mechanism can be controlled from outside the chest with a rotating steel wire. The sternal wound was closed by an elastic membrane to achieve a sterile field. Swan-Ganz monitoring was employed, and clinical outcomes evaluated. The device was successfully implanted in all patients without device-related complications or failures. Progressive approximation of sternal edges, titrated on cardiac index values, was successfully completed allowing subsequent uneventful sternal closure in all. Mean time from SPCCS to sternal closure was 70 ± 21 hours. No patient developed infective complications or late hemodynamic instability after device removal and sternal closure. One patient (14%) died of multiorgan failure on postoperative day 9. Despite the limited number of patients enrolled, the NTSS proved safe and effective in allowing complete myocardial recovery after SPCCS, avoiding hemodynamic instability related to abrupt sternal closure, with no occurrence of infective complications.

Evaluation of the cranial base in amnion rupture sequence involving the anterior neural tube: implications regarding recurrence risk.

PubMed

Jones, Kenneth Lyons; Robinson, Luther K; Benirschke, Kurt

2006-09-01

Amniotic bands can cause disruption of the cranial end of the developing fetus, leading in some cases to a neural tube closure defect. Although recurrence for unaffected parents of an affected child with a defect in which the neural tube closed normally but was subsequently disrupted by amniotic bands is negligible; for a primary defect in closure of the neural tube to which amnion has subsequently adhered, recurrence risk is 1.7%. In that primary defects of neural tube closure are characterized by typical abnormalities of the base of the skull, evaluation of the cranial base in such fetuses provides an approach for making a distinction between these 2 mechanisms. This distinction has implications regarding recurrence risk. The skull base of 2 fetuses with amnion rupture sequence involving the cranial end of the neural tube were compared to that of 1 fetus with anencephaly as well as that of a structurally normal fetus. The skulls were cleaned, fixed in 10% formalin, recleaned, and then exposed to 10% KOH solution. After washing and recleaning, the skulls were exposed to hydrogen peroxide for bleaching and photography. Despite involvement of the anterior neural tube in both fetuses with amnion rupture sequence, in Case 3 the cranial base was normal while in Case 4 the cranial base was similar to that seen in anencephaly. This technique provides a method for determining the developmental pathogenesis of anterior neural tube defects in cases of amnion rupture sequence. As such, it provides information that can be used to counsel parents of affected children with respect to recurrence risk.

40 CFR 63.906 - Inspection and monitoring requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... between the roof and the tank wall; broken, cracked, or otherwise damaged seals or gaskets on closure devices; and broken or missing hatches, access covers, caps, or other closure devices. (2) The owner or... air pollution control equipment designated as such a written explanation of the reasons why the...

40 CFR 63.1046 - Test methods and procedures.

Code of Federal Regulations, 2010 CFR

2010-07-01

... vapor leakage could occur) on the cover and associated closure devices shall be checked. Potential leak... test, the cover and closure devices shall be secured in the closed position. (3) The detection... constituent. (4) The detection instrument shall be calibrated before use on each day of its use by the...

The use of a silicon sheet for gradual wound closure after fasciotomy.

PubMed

Walker, Tobias; Gruler, Miriam; Ziemer, Gerhard; Bail, Dorothee H L

2012-06-01

We present a silicon sheet for temporary wound covering and gradual wound closure after open fasciotomy. Fasciotomy was performed in a total of 70 limbs with compartment syndrome (CS). The main etiology of CS was predominantly vascular. All patients were treated with a silicon sheet to cover the soft tissue defect and gradually reapproximate the skin margins. In 53% of the patients, a delayed final wound closure was achieved after a mean of 11.9 days. This method allows final closure of fasciotomy wounds without scar contractures, marginal necrosis, infection, or significant pain. Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

Influence of material quality and process-induced defects on semiconductor device performance and yield

NASA Technical Reports Server (NTRS)

Porter, W. A.; Mckee, W. R.

1974-01-01

An overview of major causes of device yield degradation is presented. The relationships of device types to critical processes and typical defects are discussed, and the influence of the defect on device yield and performance is demonstrated. Various defect characterization techniques are described and applied. A correlation of device failure, defect type, and cause of defect is presented in tabular form with accompanying illustrations.

[No interrupted surgical defects of the white upper lip: repair by a combined advancement and rotation flap in the lip subunit].

PubMed

Guillot, P

2013-01-01

A solid understanding of anatomy, basic surgical principles, and tissue movement is essential when undertaking the reconstruction of facial cutaneous surgical defects. Aesthetic facial reconstruction requires understanding ability to use the tissue adjacent to the defect to create a reconstruction that preserves the function of the area and the cosmetic facial units and subunits. The closure of non interrupted white upper lip defects by using a combined advancement and rotation flap is preferred for defects not overtaking 2.5 cm in diameter.

Thermic sealing in femoral catheterisation: First experience with the Secure Device.

PubMed

Sacherer, Michael; Kolesnik, Ewald; von Lewinski, Friederike; Verheyen, Nicolas; Brandner, Karin; Wallner, Markus; Eaton, Deborah M; Luha, Olev; Zweiker, Robert; von Lewinski, Dirk

2018-04-03

Devices currently used to achieve hemostasis of the femoral artery following percutaneous cardiac catheterization are associated with vascular complications and remnants of artificial materials are retained at the puncture site. The SECURE arterial closure device induces hemostasis by utilizing thermal energy, which causes collagen shrinking and swelling. In comparison to established devices, it has the advantage of leaving no foreign material in the body following closing. This study was designed to evaluate the efficacy and safety of the SECURE device to close the puncture site following percutaneous cardiac catheterization. The SECURE device was evaluated in a prospective non-randomized single-centre trial with patients undergoing 6 F invasive cardiac procedures. A total of 67 patients were enrolled and the device was utilized in 63 patients. 50 diagnostic and 13 interventional cases were evaluated. Femoral artery puncture closure was performed immediately after completion of the procedure. Time to hemostasis (TTH), time to ambulation (TTA) and data regarding short-term and 30-day clinical follow-up were recorded. Mean TTH was 4:30 ± 2:15 min in the overall observational group. A subpopulation of patients receiving anticoagulants had a TTH of 4:53 ± 1:43 min. There were two access site complications (hematoma > 5 cm). No major adverse events were identified during hospitalization or at the 30 day follow-up. The new SECURE device demonstrates that it is feasible in diagnostic and interventional cardiac catheterization. With respect to safety, the SECURE device was non-inferior to other closure devices as tested in the ISAR closure trial.

Endoscopic vacuum therapy for various defects of the upper gastrointestinal tract.

PubMed

Kuehn, Florian; Loske, Gunnar; Schiffmann, Leif; Gock, Michael; Klar, Ernst

2017-09-01

Postoperative, iatrogenic or spontaneous upper gastrointestinal defects result in significant morbidity and mortality of the patients. In the last few years, endoscopic vacuum therapy (EVT) has been recognized as a new promising method for repairing upper gastrointestinal defects of different etiology. However, probably due to insufficient data and no commercially available system for EVT of the upper gastrointestinal tract, until the end of 2014, covering of esophageal defects with self-expanding metal stents (SEMS) were still the mainstay of endoscopic therapy. The aim of this article is to review the data available about EVT for various upper gastrointestinal defects. A selective literature search was conducted in Medline and PubMed (2007-2016), taking into account all the published case series and case reports reporting on the use of EVT in the management of upper gastrointestinal defects. EVT works through intracorporal application of negative pressure at the defect zone with an electronic controlled vacuum device along a polyurethane sponge drainage. This results in closure of the esophageal defect and internal drainage of the septic focus, simultaneously. Compared to stenting, EVT enables regular viewing of wound conditions with control of the septic focus and adjustment of therapy. Moreover, endoscopical negative pressure is applicable in all esophageal regions (cricopharygeal, tubular, gastroesophageal junction) and in anastomotic anatomic variants. EVT can be used solely as a definite treatment or as a complimentary therapy combined with operative revision. In total, there are published data of more than 200 patients with upper gastrointestinal defects treated with EVT, showing succes rates from 70-100%. The available data indicate that EVT is feasible, safe and effective with good short-term and long-term clinical outcomes in the damage control of upper GI-tract leaks. Still, a prospective multi-center study has to be conducted to proof the definite benefit of EVT for patients with esophageal defects.

Device-scale CFD modeling of gas-liquid multiphase flow and amine absorption for CO 2 capture: Original Research Article: Device-scale CFD modeling of gas-liquid multiphase flow and amine absorption for CO 2 capture

DOE PAGES

Pan, Wenxiao; Galvin, Janine; Huang, Wei Ling; ...

2018-03-25

In this paper we aim to develop a validated device-scale CFD model that can predict quantitatively both hydrodynamics and CO 2 capture efficiency for an amine-based solvent absorber column with random Pall ring packing. A Eulerian porous-media approach and a two-fluid model were employed, in which the momentum and mass transfer equations were closed by literature-based empirical closure models. We proposed a hierarchical approach for calibrating the parameters in the closure models to make them accurate for the packed column. Specifically, a parameter for momentum transfer in the closure was first calibrated based on data from a single experiment. Withmore » this calibrated parameter, a parameter in the closure for mass transfer was next calibrated under a single operating condition. Last, the closure of the wetting area was calibrated for each gas velocity at three different liquid flow rates. For each calibration, cross validations were pursued using the experimental data under operating conditions different from those used for calibrations. This hierarchical approach can be generally applied to develop validated device-scale CFD models for different absorption columns.« less

Device-scale CFD modeling of gas-liquid multiphase flow and amine absorption for CO 2 capture: Original Research Article: Device-scale CFD modeling of gas-liquid multiphase flow and amine absorption for CO 2 capture

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pan, Wenxiao; Galvin, Janine; Huang, Wei Ling

In this paper we aim to develop a validated device-scale CFD model that can predict quantitatively both hydrodynamics and CO 2 capture efficiency for an amine-based solvent absorber column with random Pall ring packing. A Eulerian porous-media approach and a two-fluid model were employed, in which the momentum and mass transfer equations were closed by literature-based empirical closure models. We proposed a hierarchical approach for calibrating the parameters in the closure models to make them accurate for the packed column. Specifically, a parameter for momentum transfer in the closure was first calibrated based on data from a single experiment. Withmore » this calibrated parameter, a parameter in the closure for mass transfer was next calibrated under a single operating condition. Last, the closure of the wetting area was calibrated for each gas velocity at three different liquid flow rates. For each calibration, cross validations were pursued using the experimental data under operating conditions different from those used for calibrations. This hierarchical approach can be generally applied to develop validated device-scale CFD models for different absorption columns.« less

Seven-year follow-up of percutaneous closure of patent foramen ovale.

PubMed

Mirzada, Naqibullah; Ladenvall, Per; Hansson, Per-Olof; Johansson, Magnus Carl; Furenäs, Eva; Eriksson, Peter; Dellborg, Mikael

2013-12-01

Observational studies favor percutaneous closure of patent foramen ovale (PFO) over medical treatment to reduce recurrent stroke while randomized trials fail to demonstrate significant superiority of percutaneous PFO closure. Few long-term studies are available post PFO closure. This study reports long-term clinical outcomes after percutaneous PFO closure. Between 1997 and 2006, 86 consecutive eligible patients with cerebrovascular events, presumably related to PFO, underwent percutaneous PFO closure. All 86 patients were invited to a long-term follow-up, which was carried out during 2011 and 2012. Percutaneous PFO closure was successfully performed in 85 of 86 patients. The follow-up rate was 100%. No cardiovascular or cerebrovascular deaths occurred. Two patients (both women) died from lung cancer during follow-up. Follow-up visits were conducted for 64 patients and the remaining 20 patients were followed up by phone. The mean follow-up time was 7.3 years (5 to 12.4 years). Mean age at PFO closure was 49 years. One patient had a minor stroke one month after PFO closure and a transient ischemic attack (TIA) two years afterwards. One other patient suffered from a TIA six years after closure. No long-term device-related complications were observed. Percutaneous PFO closure was associated with very low risk of recurrent stroke and is suitable in most patients. We observed no mortality and no long-term device-related complications related to PFO closure, indicating that percutaneous PFO closure is a safe and efficient treatment even in the long term.

Study design of the CLOSURE I Trial: a prospective, multicenter, randomized, controlled trial to evaluate the safety and efficacy of the STARFlex septal closure system versus best medical therapy in patients with stroke or transient ischemic attack due to presumed paradoxical embolism through a patent foramen ovale.

PubMed

Furlan, Anthony J; Reisman, Mark; Massaro, Joseph; Mauri, Laura; Adams, Harold; Albers, Gregory W; Felberg, Robert; Herrmann, Howard; Kar, Saibal; Landzberg, Michael; Raizner, Albert; Wechsler, Lawrence

2010-12-01

Some strokes of unknown etiology may be the result of a paradoxical embolism traversing through a nonfused foramen ovale (patent foramen ovale [PFO]). The utility of percutaneously placed devices for treatment of patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO is unknown. In addition, there are no clear data about the utility of medical interventions or other surgical procedures in this situation. Despite limited data, many patients are being treated with PFO closure devices. Thus, there is a strong need for clinical trials that test the potential efficacy of PFO occlusive devices in this situation. To address this gap in medical knowledge, we designed the CLOSURE I trial, a randomized, clinical trial comparing the use of a percutaneously placed PFO occlusive device and best medical therapy versus best medical therapy alone for prevention of recurrent ischemic neurologic symptoms among persons with TIA or ischemic stroke. This prospective, multicenter, randomized, controlled trial has finished enrollment. Two-year follow-up for all 910 patients is required. The primary end point is the 2-year incidence of stroke or TIA, all-cause mortality for the first 30 days, and neurologic mortality from ≥ 31 days of follow-up, as adjudicated by a panel of physicians who are unaware of treatment allocation. This article describes the rationale and study design of CLOSURE I. This trial should provide information as to whether the STARFlex septal closure system is safe and more effective than best medical therapy alone in preventing recurrent stroke/TIA and mortality in patients with PFO and whether the STARFlex septal closure device can demonstrate superiority compared with best medical therapy alone. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00201461.

Bioprosthetics and repair of complex aerodigestive defects

PubMed Central

Udelsman, Brooks; Mathisen, Douglas J.

2018-01-01

Aerodigestive defects involving the trachea, bronchi and esophagus are a result of prolonged intubation, operative complications, congenital defects, trauma, radiation and neoplastic disease. The vast majority of these defects may be repaired primarily. Rarely, due the size of the defect, underlying complexity, or unfavorable patient characteristics, primary repair is not possible. One alternative to primary repair is bioprosthetic repair. Materials such as acellular dermal matrix and aortic homograft have been used in a variety of applications, including closure of tracheal, bronchial and esophageal defects. Herein, we review the use of bioprosthetics in the repair of aerodigestive defects, along with the unique advantages and disadvantages of these repairs. PMID:29707507

The uses of two-dimensional Doppler echocardiographic techniques preoperatively and postoperatively in a ventricular septal defect caused by penetrating trauma.

PubMed

Goldman, A P; Kotler, M N; Goldberg, S E; Parameswaran, R; Parry, W

1985-12-01

Doppler echocardiography was used to determine the site and size of a ventricular septal defect in a patient with a penetrating wound of the heart. Additional physiological measurements by Doppler study, including pulmonary artery pressure and degree of left-to-right shunting, were helpful in deciding on surgical closure of the defect as the definitive therapy in this patient. Associated intracardiac defects (e.g., mitral or tricuspid regurgitation) can be excluded by Doppler echocardiography.

Neural tube defects – recent advances, unsolved questions and controversies

PubMed Central

Copp, Andrew J.; Stanier, Philip; Greene, Nicholas D. E.

2014-01-01

Neural tube defects (NTDs) are severe congenital malformations affecting around 1 in every 1000 pregnancies. Here we review recent advances and currently unsolved issues in the NTD field. An innovation in clinical management has come from the demonstration that closure of open spina bifida lesions in utero can diminish neurological dysfunction in children. Primary prevention by folic acid has been enhanced through introduction of mandatory food fortification in some countries, although not yet in UK. Genetic predisposition comprises the majority of NTD risk, and genes that regulate folate one-carbon metabolism and planar cell polarity have been strongly implicated. The sequence of human neural tube closure events remains controversial, but study of mouse NTD models shows that anencephaly, open spina bifida and craniorachischisis result from failure of primary neurulation, while skin-covered spinal dysraphism results from defective secondary neurulation. Other ‘NTD’ malformations, such as encephalocele, are likely to be post-neurulation disorders. PMID:23790957

[Axillary approach for surgical closure of atrial septal defect].

PubMed

Gil-Jaurena, J M; Castillo, R; Zabala, J I; Conejo, L; Cuenca, V; Picazo, B

2013-08-01

Mid-line sternotomy is the routine approach for surgical repair of congenital heart diseases. However, its noticeable scar is a constant reminder of having undergone heart surgery. Several alternative approaches have been developed for simple cardiac conditions to hide the scar. Our series, consisting of 26 patients with axillary closure of atrial septal defect, is presented. The median age was 5.45 years (range 3-13), and median weight was 19.84 Kg. (range 13-37). The defect was closed directly in 13 cases, and with an autologous pericardial patch in the other 13. The number of surgical steps and time taken were the same as in median sternotomy. Functional recovery, intensive care unit stay, and hospital discharge were also standard. The cosmetic result, assessed both by patients and relatives, was excellent. Copyright © 2012 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-10

...: Tissue Adhesive With Adjunct Wound Closure Device Intended for the Topical Approximation of Skin... Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin... intended for the topical approximation of skin may comply with the requirement of special controls for...

Transcatheter patent foramen ovale closure versus medical therapy for cryptogenic stroke: a meta-analysis of randomized clinical trials.

PubMed

Riaz, Irbaz Bin; Dhoble, Abhijeet; Mizyed, Ahmad; Hsu, Chiu-Hsieh; Husnain, Muhammad; Lee, Justin Z; Lotun, Kapildeo; Lee, Kwan S

2013-12-11

There is an association between cryptogenic stroke and patent foramen ovale (PFO). The optimal treatment strategy for secondary prevention remains unclear. The purpose of this study was to analyze aggregate data examining the safety and efficacy of transcatheter device closure versus standard medical therapy in patients with PFO and cryptogenic stroke. A search of published data identified 3 randomized clinical trials for inclusion. The primary outcome was a composite end-point of death, stroke and transient-ischemic attack (TIA). Pre-defined subgroup analysis was performed with respect to baseline characteristics including age, sex, atrial septal aneurysm and shunt size. Data was synthesized using a random effects model and results presented as hazard ratios (HRs) with 95% confidence intervals (CIs). A cohort of 2,303 patients with a history of cryptogenic stroke and PFO were randomized to device closure (n = 1150) and medical therapy (n = 1153). Mean follow-up was 2.5 years. Transcatheter closure was not superior to medical therapy in the secondary prevention of stroke or TIA in intention-to-treat analysis (HR: 0.66, 95% CI: 0.43 to 1.01; p = 0.056). However, the results were statistically significant using per-protocol analysis (HR: 0.64, 95% CI: 0.41 to 0.98; p = 0.043). Males had significant benefit with device closure (HR: 0.48, 95% CI: 0.24 to 0.96; p = 0.038). In this meta-analysis, using intention-to-treat analysis, transcatheter device closure of PFO was not superior to standard medical therapy in the secondary prevention of cryptogenic stroke. Transcatheter closure was superior using per-protocol analysis.

Percutaneous closure of patent arterial ducts in patients from high altitude: a sub-Saharan experience.

PubMed

Tefera, Endale; Qureshi, Shakeel A; Bermudez-Cañete, Ramòn; Rubio, Lola

2015-01-01

At high altitude, patent arterial ducts tend to be larger and associated with pulmonary hypertension. Patent ductus arteriosus device closure in this background could be challenging. We report our experience with percutaneous closure of patent arterial ducts using a variety of devices in patients residing in a high altitude. This is a retrospective review of the case records of 145 patients (age 9 months-20 years, mean 5.6 ± 3.9 years, and weight 7-54 kg, mean 17.7 ± 9.4) with duct sizes ranging between 2 and 21 mm, (mean, 5.8 ± 2.7) who underwent percutaneous closure of patent arterial ducts. One hundred thirty-six (93.8%) of the patients were from a geographic area of 2100-2800 m above sea level. Successful device closure was achieved in 143 cases. It was difficult to achieve device stability in two patients with expansile ducts. Therefore, they were treated surgically. The devices used were various types of duct occluder devices in 131 patients, while atrial and ventricular septal occluders were used in eight patients. For the group, mean systolic pulmonary artery (PA) pressure decreased from 47.0 ± 16.7 mmHg before occlusion to 29.0 ± 7.4 mmHg after occlusion (P ≤ 0.001)., mean diastolic PA pressure from 25.0 ± 10.9 mmHg to 14.8 ± 6.0 mmHg and the average mean PA pressure decreased from 35.9 ± 13.5 mmHg to 21.1 ± 6.5 mmHg. Complications (4.8%) included device and coil embolization, bleeding, and pulse loss. On follow-up (mean duration of 36.1 ± 12.1 months, range 12-62 months), 137 patients were in functional class 1, 3 had residual shunt, 2 had device migration and one patient had persisting pulse loss. Successful duct closure was achieved in the vast majority of patients, even though the ducts were larger and significant number of them had pulmonary hypertension in this high altitude group. There was a relatively higher incidence of residual shunts and device migration in this series, generally due to the nonavailability of optimal device and surgical support. Long-term follow-up is required before we can draw conclusions with regard to the sustainability of drop in PA pressures. Septal Occluder devices may be a possible alternative for large tubular or window-type ducts with severe pulmonary hypertension, where there may be concerns about the size and stability of duct occluder devices.

Unclosed fascial defect: is it the risk to develop port-site hernia after laparoscopic cholecystectomy?

PubMed

Tangjaroen, Somard; Watanapa, Prasit

2014-02-01

Port-site hernia (PSH) is one of the complications after laparoscopic cholecystectomy (LC). Closure of the fascial defect has been mentioned to prevent such complication. However, the results are still controversial. The present study was done to clarify whether unclosed fascial defect was actually the risk factor for the development of PSH MATERIAL AND METHOD: Two hundred ninety four patients underwent LC by a single surgeon at Kalasin Hospital between 2007 and 2010. The procedure was done by using a four-port technique without closure of any fascial defects. The male:female ratio was 85:209, and the mean body mass index was 24.38 +/- 3.33 (SD). The mean operative time was 18.71 +/- 3.76 minutes and there was no postoperative wound infection. Patients were regularly followed-up and underwent both supine and upright physical examination. The mean duration of follow-up period was 4.94 +/- 1.31 years with the shortest follow-up period of two years. None of the patients in the present study developed PSH in any port sites during the follow-up period. Unclosed fascial defect may not have the significant risk factor of developing PSH after LC.

[Management of cerebrospinal fluid leaks according to size. Our experience].

PubMed

Alobid, Isam; Enseñat, Joaquim; Rioja, Elena; Enriquez, Karla; Viscovich, Liza; de Notaris, Matteo; Bernal-Sprekelsen, Manuel

2014-01-01

We present our experience in the reconstruction of cerebrospinal fluid (CSF) leaks according to their size and location. Fifty-four patients who underwent advanced skull base surgery (large defects) and 62 patients with CSF leaks of different origin (small and medium-sized defects) were included. Large defects were reconstructed with a nasoseptal pedicled flap positioned on fat and fascia lata and lumbar drainage was used. In small and medium-sized leaks of other origin, intrathecal fluorescein 5% was applied previously to identify the defect. Fascia lata in an underlay position was used for reconstruction, which was then covered with mucoperiosteum from the turbinate. Perioperative antibiotics were administered for 5-7 days. Nasal packing was removed after 24-48 hours. The most frequent aetiology for small and medium-sized defects was spontaneous (48.4%), followed by trauma (24.2%), iatrogenic (5%) and others. The success rate was of 91% after the first surgery and 98% in large skull base defects and small/medium-sized respectively. After rescue surgery, the rate of closure achieved was 100%. The follow-up was 15.6 ± 12.4 months for large defects and 75.3 ± 51.3 months for small/medium-sized defects without recurrence. Endoscopic surgery for closure of any type of skull base defect is the gold standard approach. Defect size does not play a significant role in the success rate. Fascia lata and mucoperiosteum allow a reconstruction of small/medium-sized defects. For larger skull base defects, a combination of fat, fascia lata and nasoseptal pedicled flaps provide a successful reconstruction. Copyright © 2013 Elsevier España, S.L. All rights reserved.

Novel percutaneous suture-mediated patent foramen ovale closure technique. Early results of the NobleStitch EL Italian Registry.

PubMed

Gaspardone, Achille; De Marco, Federico; Sgueglia, Gregory A; De Santis, Antonella; Iamele, Maria; D'Ascoli, Emanuela; Tusa, Maurizio; Corciu, Anca; Mullen, Michael; Nobles, Anthony; Carminati, Mario; Bedogni, Francesco

2018-04-03

To assess the efficacy of a novel percutaneous "device-less" suture mediated patent foramen ovale (PFO) closure system. Between June 2016 and October 2017, a prospective registry aimed at assessing the safety and efficacy of the NobleStitch EL (HeartStitch, Fountain Valley, CA) suture-based PFO closure system was carried out at 12 sites in Italy. Among 200 consecutive evaluated patients, 192 were considered suitable for suture-mediated PFO closure (44±13 years, 114 women). Suture of the septum with the NobleStitch EL system was carried out successfully in 186 (96%) patients. Median fluoroscopy time was 16.1 (13.0-22.5) minutes and contrast volume 200 (150-270) ml. At 206±130 days follow-up, microbubbles transthoracic echocardiography with Valsalva maneuver revealed no RLS (grade 0) in 139 (75%) patients and RLS grade ≤1 in 166 (89%) patients. Significant RLS was present in 20 (11%) patients (grade 2 and 3 in 11 and 9 patients, respectively). There were no device-related complications. The early results of this first Italian Registry indicates that the suture mediated "deviceless" closure of PFO is feasible in the majority of septal anatomies, provides an effective closure of PFO comparable to traditional devices with an excellent safety profile at medium term follow-up.

Cleft closure and undersizing annuloplasty improve mitral repair in atrioventricular canal defects

PubMed Central

Padala, Muralidhar; Vasilyev, Nikolay V.; Owen, James W.; Jimenez, Jorge H.; Dasi, Lakshmi P.; del Nido, Pedro J.; Yoganathan, Ajit P.

2009-01-01

Objective Reoperation rates to correct left atrioventricular valve regurgitation after primary repair of atrioventricular canal defects remain relatively high. The causes of valvular regurgitation are likely multifactorial, and simple cleft closure is often insufficient to prevent recurrence. Methods To elucidate the mechanisms leading to regurgitation, we conducted hemodynamic studies using isolated native mitral valves. Anatomy of these valves was altered to mimic atrioventricular canal type valves and studied under pediatric hemodynamic conditions. The impact of subvalvular geometry, cleft closure, annular dilatation, and annular undersizing on regurgitation were investigated. Results Papillary muscle position did not have a significant effect on regurgitation. Cleft closure had a significant impact on valvular competence, with reduction in regurgitation volume with increased cleft closure. Regurgitation volume decreased from 12.5 ± 2.4 mL/beat for an open cleft to 4.9 ± 1.9 mL/beat for a partially closed cleft and to 1.4 ± 1.6 mL/beat when the cleft was completely closed. Annular dilatation had a significant impact on regurgitation even after cleft closure. A 40% increase in annular size increased regurgitation by 59% for a partially closed cleft and by 84% for a fully closed cleft. Reducing the annular size by 20% from the physiologic level decreased the regurgitation volume by 12% for a fully open cleft and by 58% for the partially closed cleft case. Conclusions Annular dilatation after primary repair has a potentially significant role in the recurrence of atrioventricular valve regurgitation. Reducing the annular size and restricting dilatation as an adjunct to cleft closure is a promising surgical approach in such valve anatomies. PMID:19026810

Clinical efficiency and safety analysis of transcatheter closure of multiple atrial septal defects in adults.

PubMed

Song, Zhi-Yuan; He, Guo-Xiang; Shu, Mao-Qin; Hu, Hou-Yuan; Tong, Shi-Fei; Ran, Bo-Li; Liu, Jian-Ping; Li, Yong-Hua; Jing, Tao

2009-03-01

Transcatheter closure of atrial septal defects (ASDs) is currently a reliable alternative to surgery, even though challenging in patients with multiple ASDs. The aim of this study was to evaluate the clinical efficiency and safety of transcatheter closure in multiple ASDs. Multiple ASDs were diagnosed by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE). The occlusive condition and distance between 2 adjacent ASDs were measured by TTE examination. Then, the number and size of the occluder(s) was determined. TTE examinations were performed after transcatheter closure as follow-up. The transcatheter procedure was successful in 15 patients with multiple ASDs, using a single occluder in 9 patients and 2 occluders in the remaining 6 patients. Overall, 21 ASD occluders were implanted. During a follow-up period of 6 mo to 5 y, a slight residual shunt was found in 1 patient without any symptoms; a moderate residual shunt was identified at the inferior vena cava and the occluder was removed by surgery 1 mo after procedure. Other complications, including endocarditis, arrhythmia, thromboembolism, and atrioventricular valve damage were not recorded in any of the 15 patients during the follow-up period. Transcatheter closure of multiple ASDs is safe and efficient. Two occluders are necessary for the distance of 2 ASDs more than 7 mm, and a single occluder is sufficient for those 7 mm or less. Copyright (c) 2009 Wiley Periodicals, Inc.

Transcatheter closure of large patent ductus arteriosus with severe pulmonary arterial hypertension: Short and intermediate term results.

PubMed

Bhalgat, Parag S; Pinto, Robin; Dalvi, Bharat V

2012-07-01

To assess the efficacy and safety of transcatheter closure (TCC) of patent ductus arteriosus (PDA) with severe pulmonary arterial hypertension (PHT). TCC of small and moderate-sized PDAs is well established. However, there is a paucity of data on TCC of large PDA with severe PHT. This is a retrospective observational study of 76 patients with large PDA and severe PHT who were referred for TCC. Multiple clinical and investigational parameters were evaluated to decide the reversibility of PHT. Following the TCC, patients were serially followed up to assess the efficacy and safety of closure and its impact on PHT. Of 76 patients, nine were found to have PDA with Eisenmenger's syndrome. Of remaining 67, two were thought to have irreversible PHT based on hemodynamic data obtained after balloon occlusion of the duct. Sixty five patients, who eventually underwent TCC of PDA, had a median age of 9.1 years (range 1 month to 40 years). The weight ranged between 2.5 to 62 kg (median 14 kg). The PDA size was 9.1 ± 4.6 mm. The mean systolic pulmonary artery pressure was 66.9 ± 15.3 mm Hg. Duct occluder was used in 63 and muscular ventricular septal defect closure device in 2. The follow up was available in 56 (86%) with a mean follow up period of 65 ± 34 months. All the patients had complete closure of the PDA at 6 months follow up. Mild obstruction of left pulmonary artery (n=3) and aortic isthmus flow (n=6) was noted at the time of discharge. During the follow up, partial or complete resolution of PHT was observed in all the patients in whom Doppler-derived right ventricular systolic pressure was recorded (available in 40 of 56 patients). TCC of large PDA with severe PHT and significant left to right shunt was found to be effective and safe in the short and intermediate term.

Surgery for doubly committed ventricular septal defects.

PubMed

Shamsuddin, Ahmad Mahir; Chen, Yen Chuan; Wong, Abdul Rahim; Le, Trong-Phi; Anderson, Robert H; Corno, Antonio F

2016-08-01

Doubly committed ventricular septal defects (VSDs) account for up to almost one-third of isolated ventricular septal defects in Asian countries, compared with only 1/20th in western populations. In our surgical experience, this type of defect accounted for almost three-quarters of our practice. To date, patch closure has been considered the gold standard for surgical treatment of these lesions. Our objectives are to evaluate the indications and examine the outcomes of surgery for doubly committed VSDs. Between October 2013, when our service of paediatric cardiac surgery was opened, and December 2014, 24 patients were referred for surgical closure of VSDs. Among them, 17 patients (71%), with the median age of 6 years, ranging from 2 to 9 years, and with a median body weight of 19 kg, ranging from 11 to 56 kg, underwent surgical repair for doubly committed defects. In terms of size, the defect was considered moderate in 4 and large in 13. Aortic valvular regurgitation (AoVR) was present in 11 patients (65%) preoperatively, with associated malformations found in 14 (82%), with 5 patients (29%) having two or more associated defects. After surgery, there was trivial residual shunting in 2 patients (12%). AoVR persisted in 6 (35%), reducing to trivial in 5 (29%) and mild in 1 (6%). Mean stays in the intensive care unit and hospital were 2.6 ± 1.2 days, ranging from 2 to 7 days, and 6.8 ± 0.8 days, ranging from 6 to 9 days, respectively. The mean follow-up was 14 ± 4 months, ranging from 6 to 20 months, with no early or late deaths and without clinical deterioration. The incidence of doubly committed lesions is high in our experience, frequently associated with AoVR and other associated malformation. Early detection is crucial to prevent further progression of the disease. Patch closure remains the gold standard in management, not least since it allows simultaneous repair of associated intracardiac defects. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

High expression of A-type lamin in the leading front is required for Drosophila thorax closure.

PubMed

Kosakamoto, Hina; Fujisawa, Yuya; Obata, Fumiaki; Miura, Masayuki

2018-05-05

Tissue closure involves the coordinated unidirectional movement of a group of cells without loss of cell-cell contact. However, the molecular mechanisms controlling the tissue closure are not fully understood. Here, we demonstrate that Lamin C, the sole A-type lamin in Drosophila, contributes to the process of thorax closure in pupa. High expression of Lamin C was observed at the leading front of the migrating wing imaginal discs. Live imaging analysis revealed that knockdown of Lamin C in the thorax region affected the coordinated movement of the leading front, resulting in incomplete tissue fusion required for formation of the adult thorax. The closure defect due to knockdown of Lamin C correlated with insufficient accumulation of F-actin at the front. Our study indicates a link between A-type lamin and the cell migration behavior during tissue closure. Copyright © 2018 Elsevier Inc. All rights reserved.

The posterior nasoseptal flap: A novel technique for closure after endoscopic transsphenoidal resection of pituitary adenomas

PubMed Central

Barger, James; Siow, Matthew; Kader, Michael; Phillips, Katherine; Fatterpekar, Girish; Kleinberg, David; Zagzag, David; Sen, Chandranath; Golfinos, John G.; Lebowitz, Richard; Placantonakis, Dimitris G.

2018-01-01

Background: While effective for the repair of large skull base defects, the Hadad-Bassagasteguy nasoseptal flap increases operative time and can result in a several-week period of postoperative crusting during re-mucosalization of the denuded nasal septum. Endoscopic transsphenoidal surgery for pituitary adenoma resection is generally not associated with large dural defects and high-flow cerebrospinal fluid (CSF) leaks requiring extensive reconstruction. Here, we present the posterior nasoseptal flap as a novel technique for closure of skull defects following endoscopic resection of pituitary adenomas. This flap is raised in all surgeries during the transnasal exposure using septal mucoperiosteum that would otherwise be discarded during the posterior septectomy performed in binostril approaches. Methods: We present a retrospective, consecutive case series of 43 patients undergoing endoscopic transsphenoidal resection of a pituitary adenoma followed by posterior nasoseptal flap placement and closure. Main outcome measures were extent of resection and postoperative CSF leak. Results: The mean extent of resection was 97.16 ± 1.03%. Radiographic measurement showed flap length to be adequate. While a defect in the diaphragma sellae and CSF leak were identified in 21 patients during surgery, postoperative CSF leak occurred in only one patient. Conclusions: The posterior nasoseptal flap provides adequate coverage of the surgical defect and is nearly always successful in preventing postoperative CSF leak following endoscopic transsphenoidal resection of pituitary adenomas. The flap is raised from mucoperiosteum lining the posterior nasal septum, which is otherwise resected during posterior septectomy. Because the anterior septal cartilage is not denuded, raising such flaps avoids the postoperative morbidity associated with the larger Hadad-Bassagasteguy nasoseptal flap. PMID:29527390

Intracardiac Ultrasound Assessment of Atrial Septal Defect: Comparison with Transthoracic Echocardiographic, Angiocardiographic, and Balloon-Sizing Measurements

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sheng-Ling, Jan; Hwang, Betau; Lee, P.-C.

Purpose: Accurate evaluation of the size, location and adjacent structure of an atrial septal defect (ASD) is very important in the selection of patients for further management. We directly compared the utility of transthoracic echocardiography, angiocardiography, balloon sizing, and intracardiac ultrasound (ICUS) in the detection of ASD.Methods: Twenty-one children underwent an ICUS study of ASD after routine clinical and laboratory studies. All patients had received transthoracic echocardiography (TTE), cardiac catheterization, cineangiography, and balloon sizing before the ICUS to evaluate the ASD.Results: There was a significant correlation between the ICUS-derived ASD diameter and the other methods (p < 0.001). The balloon-sizingmore » diameter was estimated by the equation: TTE diameter x 1.09 + 3.9 mm. There was a good correlation between the predicted and measured balloon-sizing diameter (r = 0.963; p < 0.001).Conclusion: It is worthwhile spending a few minutes to perform ICUS during cardiac catheterization since it will provide more detailed information on and high resolution images of atrial septal morphology, especially for patients undergoing transcatheter closure by device.« less

Percutaneous closure of a large patent ductus arteriosus in a preterm newborn weighing 1400 g without using arterial sheath: an innovative technique.

PubMed

Garg, Gaurav; Garg, Vishal; Prakash, Amit

2018-03-01

Percutaneous closure of patent ductus arteriosus is well established in infants weighing >5 kg, but data regarding outcome of preterm especially very low birth weight infants is minimal. Although surgical ligation of patent ductus arteriosus is the preferred and well-accepted modality of treatment after failure of drug therapy in preterm infants, it has also got its own demerits in such a small and fragile subset. Device closure in infants weighing <1.5 kg is rarely attempted because of high chances of complications, especially acute arterial injury due to the arterial sheath. We received a 1.4-kg ventilator-dependent infant for closure of large patent ductus arteriosus. Percutaneous closure of patent ductus arteriosus was done successfully and the infant was discharged on room air with a weight of 1.8 kg. We present here an innovative technique in which successful patent ductus arteriosus device closure was done in a 1.4-kg infant without using arterial sheath.

Effectiveness of an annular closure device in a "real-world" population: stratification of registry data using screening criteria from a randomized controlled trial.

PubMed

Kuršumović, Adisa; Rath, Stefan A

2018-01-01

Increased focus has been put on the use of "'real-world" data to support randomized clinical trial (RCT) evidence for clinical decision-making. The objective of this study was to assess the performance of an annular closure device (ACD) after stratifying a consecutive series of "real-world" patients by the screening criteria of an ongoing RCT. This was a single-center registry analysis of 164 subjects who underwent limited discectomy combined with ACD for symptomatic lumbar disc herniation. Patients were stratified into two groups using the selection criteria of a pivotal RCT on the same device: Trial (met inclusion; n=44) or non-Trial (did not meet inclusion; n=120). Patient-reported outcomes, including Oswestry Disability Index (ODI) and visual analog scale (VAS) for leg and back pain, and adverse events were collected from baseline to last follow-up (mean: Trial - 15.6 months; non-Trial - 14.6 months). Statistical analyses were performed with significance set at p <0.05. Patient-reported outcomes were not significantly different between groups at last ( p ≥0.15) and clinical success (≥15-point improvement in ODI score; ≥20-point improvement in VAS scores) was achieved in both the groups. Three non-Trial (2.5%) and three Trial (6.8%) patients experienced symptomatic reherniation ( p =0.34). Rates of reoperation, ACD mesh dislocation/separation, and other radiographic findings were similar between groups ( p =1.00). Outcomes with the ACD appeared advantageous in both the groups, particularly in comparison with historical reherniation rates reported in the same high-risk, large annular defect population. Stratification of this "real-world" series on the basis of RCT screening criteria did not result in significant between-group differences. These findings suggest that the efficacy of the ACD extends beyond the strictly defined patient population being studied in the RCT of this device. Furthermore, reducing the reherniation rate following lumbar discectomy has positive clinical and economic implications.

A Novel Technique of Posterolateral Suturing in Thoracoscopic Diaphragmatic Hernia Repair

PubMed Central

Boo, Yoon Jung; Rohleder, Stephan; Muensterer, Oliver J.

2017-01-01

Background  Closure of the posterolateral defect in some cases of congenital diaphragmatic hernia (CDH) can be difficult. Percutaneous transcostal suturing is often helpful to create a complete, watertight closure of the diaphragm. A challenge with the technique is passing the needle out the same tract that it entered so that no skin is caught when the knots are laid down into the subcutaneous tissue. This report describes a novel technique using a Tuohy needle to percutaneously suture the posterolateral defect during thoracoscopic repair of CDH. Case  We report a case of a 6-week-old infant who presented with a CDH and ipsilateral intrathoracic kidney that was repaired using thoracoscopic approach. The posterolateral part of the defect was repaired by percutaneous transcostal suturing and extracorporeal knot tying. To assure correct placement of the sutures and knots, a Tuohy needle was used to guide the suture around the rib and out through the same subcutaneous tract. The total operative time was 145 minutes and there were no perioperative complications. The patient was followed up for 3 months, during which there was no recurrence. Conclusion  Our percutaneous Tuohy technique for closure of the posterolateral part of CDH enables a secure, rapid, and tensionless repair. PMID:28804698

A Novel Technique of Posterolateral Suturing in Thoracoscopic Diaphragmatic Hernia Repair.

PubMed

Boo, Yoon Jung; Rohleder, Stephan; Muensterer, Oliver J

2017-01-01

Background  Closure of the posterolateral defect in some cases of congenital diaphragmatic hernia (CDH) can be difficult. Percutaneous transcostal suturing is often helpful to create a complete, watertight closure of the diaphragm. A challenge with the technique is passing the needle out the same tract that it entered so that no skin is caught when the knots are laid down into the subcutaneous tissue. This report describes a novel technique using a Tuohy needle to percutaneously suture the posterolateral defect during thoracoscopic repair of CDH. Case  We report a case of a 6-week-old infant who presented with a CDH and ipsilateral intrathoracic kidney that was repaired using thoracoscopic approach. The posterolateral part of the defect was repaired by percutaneous transcostal suturing and extracorporeal knot tying. To assure correct placement of the sutures and knots, a Tuohy needle was used to guide the suture around the rib and out through the same subcutaneous tract. The total operative time was 145 minutes and there were no perioperative complications. The patient was followed up for 3 months, during which there was no recurrence. Conclusion  Our percutaneous Tuohy technique for closure of the posterolateral part of CDH enables a secure, rapid, and tensionless repair.

Enhancement of wound closure by modifying dual release patterns of stromal-derived cell factor-1 and a macrophage recruitment agent from gelatin hydrogels.

PubMed

Kim, Yang-Hee; Tabata, Yasuhiko

2017-11-01

The objective of the present study is to evaluate the effects of the release patterns of stromal derived factor (SDF)-1 and sphingosine-1 phosphate agonist (SEW2871), used as MSC and macrophage recruitment agents, on the wound closure of diabetic mouse skin defects. To achieve different release patterns, hydrogels were prepared using two types of gelatin with isoelectric points (IEP) of 5 and 9, into which SDF-1 and SEW2871 were then incorporated in various combinations. When the hydrogels incorporating SDF-1 and SEW2871 were applied into wound defects of diabetic mice, the number of MSCs and macrophages recruited to the defects and the levels of pro- and anti- inflammatory cytokines were found to be dependent on the release profiles of SDF-1 and SEW2871. Of particular interest was the case of a rapid release of SDF-1 combined with a controlled release of SEW2871. This resulted in a higher number of M2 macrophages and gene expression levels of anti-inflammatory cytokines 3 days after implantation and faster wound closure than when pairing the controlled release of SDF-1 with a rapid release of SEW2871. Therefore, the present study demonstrates that different release patterns of SDF-1 and SEW2871 can enhance the in vivo recruitment of MSCs and macrophages, and can promote skin wound closure through the modulation of inflammation. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

[The primary closure approach of dog bite injuries of the nose].

PubMed

Zieliński, Tomasz

2010-01-01

Biting of humans by domestic animals, especially by dogs, is common injury which causes suffering and pain, might be a cause of disability or even death. It is associated with high risk of bacterial infection of the wounds or even transfection of rabies virus. Bites are usually to the upper and lower limbs, while the face is third in a raw localization of bites. Within the face, the nose and lips are injured the most often. The goal of this paper is presentation selected methods and obtained results of primary closure of dog bite injures of the nose. There were 16 patients with dog bites injures of the nose treated in the Department of Plastic, Reconstructive and Aesthetic Surgery of the Medical University of Łódź in the years 2003-2008. The patients were 11 to 46 years old. Bites caused either superficial laceration of the skin, tearing of the nostril wing or even major defects of the tissues. In 7 patients superficial wounds a direct closure was done and antibiotic ointment was applied. In 7 patients a defect of the skin was covered with a skin graft taken from retroauricular area, but in 2 of the patients of this group repair of mucosa and alar cartilage was done. In two persons with full thickness defects of the nose reconstruction was performed with the use of a pedicled nosolabial flap. Complications occurred only in 1 patient who developed infection in the wound. In all other patients there were no complications. Good aesthetic results were obtained. Primary closure approach of bite injures with tissue defect is not associated with larger risk than in the case in secondary such approach, and should be implemented always whenever it is possible in order to avoid risk of wound and scars which require further reconstructive procedures in future.

Papineau debridement, Ilizarov bone transport, and negative-pressure wound closure for septic bone defects of the tibia.

PubMed

Karargyris, Orestis; Polyzois, Vasilios D; Karabinas, Panayiotis; Mavrogenis, Andreas F; Pneumaticos, Spyros G

2014-08-01

Ilizarov pioneered bone transport using a circular external fixator. Papineau described a staged technique for the treatment for infected pseudarthrosis of the long bones. This article presents a single-stage Papineau technique and Ilizarov bone transport, and postoperative negative-pressure wound dressing changes for septic bone defects of the tibia. We studied the files of seven patients (mean age, 32 years) with septic bone defects of the tibia treated with a Papineau technique and Ilizarov bone transport in a single stage, followed by postoperative negative-pressure wound dressing changes. All patients had septic pseudarthrosis and skin necrosis of the tibia. The technique included a single-stage extensive surgical debridement of necrotic bone, open bone grafting with cancellous bone autograft and bone transport, and postoperative negative-pressure wound dressing changes for wound closure. The mean time from the initial injury was 6 months (range, 4-8 months). The mean follow-up was 14 months (range, 10-17 months). All patients experienced successful wound healing at a mean of 29 days. Six patients experienced successful bone regeneration and union at the docking side at a mean of 6 months. One patient experienced delayed union at the docking site, which was treated with autologous cancellous bone grafting. Two patients experienced pin track infection, which was successfully treated with antibiotics and pin site dressing changes. All patients were able to return to their work and previous levels of activity, except one patient who had a stiff ankle joint and had to change his job. No patient experienced recurrence of infection, or fracture of the regenerated or transported bone segment until the period of this study. The combined Papineau and Ilizarov bone transport technique with negative-pressure wound closure provides for successful eradication of the infection, reconstruction of the bone defect, and soft-tissue closure. A single-stage surgical treatment is feasible, without any complications.

Impact of Pulmonary Flow Study Pressure on Outcomes After One-Stage Unifocalization.

PubMed

Trezzi, Matteo; Albanese, Sonia B; Albano, Antonio; Rinelli, Gabriele; D'Anna, Carolina; Polito, Angelo; Cetrano, Enrico; Carotti, Adriano

2017-12-01

The purpose of this study was to evaluate the accuracy of the pulmonary flow study in (1) predicting the feasibility of concomitant intracardiac repair after one-stage unifocalization; and in (2) predicting long-term survival and the onset of right ventricular dysfunction after surgery. Between October 1996 and July 2015, a flow study was obtained in 95 patients undergoing complete one-stage unifocalization for pulmonary atresia with ventricular septal defect and major aortopulmonary collaterals. The ability to achieve 100% flow (approximately 2.5 L · min -1 · m -2 ) into the pulmonary bed at a mean pressure of 30 mm Hg or less was utilized as an indicator for acceptability of ventricular septal defect closure. Overall survival was 78% ± 6% at 15 years. Sixty-four patients underwent successful one-stage intracardiac repair. The flow study accurately predicted suitability for VSD closure (area under the curve = 0.855). After one-stage ventricular septal defect closure, no difference in survival was observed after stratification according to flow study pressures (25 mm Hg or less versus greater than 25 mm Hg, log rank p = 0.20). At a median follow-up of 7 years, no association was found between flow study pressure and the onset of right ventricular dysfunction (p = 0.21). Overall, the inability to achieve final intracardiac repair was a strong predictor of death (hazard ratio 9.14, 95% confidence interval: 1.98 to 42.07, p < 0.0001). Suitability for ventricular septal defect closure is reliably defined by the flow study with a cutoff of 30 mm Hg. Flow study pressure values do not affect long-term outcomes. The ability to obtain intracardiac repair (in either one or more stages) is the strongest predictor of survival. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Transcatheter Closure of Patent Ductus Arteriosus in Children with the Occlutech Duct Occluder.

PubMed

Bilici, Meki; Demir, Fikri; Akın, Alper; Türe, Mehmet; Balık, Hasan; Kuyumcu, Mahir

2017-12-01

The aim of this study was to evaluate the feasibility, efficacy and safety of transcatheter closure of patent ductus arteriosus (PDA) with the Occlutech duct occluder (ODO) in children. We reviewed the clinical records of 71 patients who underwent percutaneous closure of PDA with an ODO between September 2014 and August 2016. The Occlutech duct occluder was applied to 71 patients during the study period (September 2014-August 2016), and the results were analyzed in this study. Forty-two of the patients were female and 29 male. The median age was 20.5 months (range, 6-194 months) and median weight was 16 kg (range, 6-68 kg). The PDA was classified as type A in 54 patients (76.1%), type E in 14 (19.7%), type C in 2 (2.8%) and type B in 1 (1.4%) based on the Krichenko classification. A standard ODO device was used for the transcatheter closure procedure in 66 patients and the long-shank ODO device in 5. In the echocardiographic measurement of PDA, the median smallest diameter was 2.7 mm (range, 1.5-7.0 mm), and in the angiographic measurement, the median smallest diameter was 2.5 mm (range, 1.5-6.5 mm). All 71 patients underwent successful PDA closure with the ODO. Angiography following the procedure showed complete closure in 47 patients (66.2%), mild residual shunt in 13 patients (18.3%) and a trivial shunt in 11 patients (15.5%). Color flow Doppler echocardiogpaphy at 24 h post-implantation showed that complete closure was achieved in 65 patients (91.5%), and 6 patients (8.5%) had mild residual shunt. All patients (100%) had complete closure at 30 days of follow-up. The results of this study showed that the Occlutech PDA occluder device is safe and effective in the closure of PDA. As the pulmonary artery side of the device is wider than the aortic side, protrusion toward the aortic side and embolization are prevented, but there is residual shunt in the early period, although this residual shunt disappeared after a few months.

Cost-effectiveness analysis of different devices used for the closure of small-to-medium-sized patent ductus arteriosus in pediatric patients

PubMed Central

El-Saiedi, Sonia A; El Sisi, Amal M; Mandour, Rodina Sobhy; Abdel-Aziz, Doaa M; Attia, Wael A

2017-01-01

Aims: In this study, we examined the differences in cost and effectiveness of various devices used for the closure of small to medium sized patent ductus arteriosus (PDA). Setting and Design: We retrospectively studied 116 patients who underwent closure of small PDAs between January 2010 and January 2015. Subjects and Methods: Three types of devices were used: the Amplatzer duct occluder (ADO) II, the cook detachable coil and the Nit Occlud coil (NOC). Immediate and late complications were recorded and patients were followed up for 3 months after the procedure. Statistical Methods: All statistical calculations were performed using Statistical Package for the Social Science software. P <0.05 were considered significant. Results: We successfully deployed ADO II devices in 33 out of 35 cases, cook detachable coils in 36 out of 40 cases and NOCs in 38 out of 41 cases. In the remaining nine cases, the first device was unsuitable or embolized and required retrieval and replacement with another device. Eleven patients (9.5%) developed vascular complications and required anticoagulation therapy. Patients who had hemolysis or vascular complications remained longer in the intensive care unit, with consequently higher total cost (P = 0.016). Also, the need for a second device increased the cost per patient. Conclusions: The cook detachable coil is the most cost-effective device for closure of small-to medium-sized PDAs. Calculations of the incremental cost-effectiveness. (ICE) revealed that the Cook detachable coil had less ICE than the ADO II and NOC. The NOC was more effective with fewer complications. PMID:28566822

Effects of transcatheter closure of Fontan fenestration on exercise tolerance. kidecho@yahoo.com.

PubMed

Momenah, Tarek S; Eltayb, Haifa; Oakley, Reida El; Qethamy, Howeida Al; Faraidi, Yahya Al

2008-05-01

Baffle fenestration is associated with a significantly better outcome in standard and high-risk patients undergoing completion of Fontan. We report the effects of subsequent transcatheter closure of fenestration on exercise capacity and oxygen saturation. Sixteen patients with a mean age of 10.3 years underwent Amplatzer septal occluder (ASO) device transcatheter closure of Fontan fenestration. All had a fenestrated Fontan operation 6 month to 8 years prior to the procedure. A stress test was performed before and after device closure of fenestration in 14 patients (2 patients did not tolerate stress test before the procedure). The fenestrations in all patients were successfully occluded with the use of the Amplatzer device occluder. No complications occurred during or after the procedure. O2 saturation increased from a mean 85.1 +/- 7.89% to 94.5 +/- 3.63% (p < 0.01) at rest and from 66.2 +/- 12.86% to 87.2 +/- 8.64% (p < 0.01) following exercise. Exercise duration has also increased from 8.22 +/- 2.74 min to 10.29 +/- 1.91 min (p < 0.05). Transcatheter closure of Fontan fenestration increases the duration of exercise capacity and increases O2 saturation at rest and after exercise.

The Boomerang-shaped Pectoralis Major Musculocutaneous Flap for Reconstruction of Circular Defect of Cervical Skin.

PubMed

Azuma, Shuchi; Arikawa, Masaki; Miyamoto, Shimpei

2017-11-01

We report on a patient with a recurrence of oral cancer involving a cervical lymph node. The patient's postexcision cervical skin defect was nearly circular in shape, and the size was about 12 cm in diameter. The defect was successfully reconstructed with a boomerang-shaped pectoralis major musculocutaneous flap whose skin paddle included multiple intercostal perforators of the internal mammary vessels. This flap design is effective for reconstructing an extensive neck skin defect and enables primary closure of the donor site with minimal deformity.

An FGF3-BMP Signaling Axis Regulates Caudal Neural Tube Closure, Neural Crest Specification and Anterior-Posterior Axis Extension

PubMed Central

Anderson, Matthew J.; Schimmang, Thomas; Lewandoski, Mark

2016-01-01

During vertebrate axis extension, adjacent tissue layers undergo profound morphological changes: within the neuroepithelium, neural tube closure and neural crest formation are occurring, while within the paraxial mesoderm somites are segmenting from the presomitic mesoderm (PSM). Little is known about the signals between these tissues that regulate their coordinated morphogenesis. Here, we analyze the posterior axis truncation of mouse Fgf3 null homozygotes and demonstrate that the earliest role of PSM-derived FGF3 is to regulate BMP signals in the adjacent neuroepithelium. FGF3 loss causes elevated BMP signals leading to increased neuroepithelium proliferation, delay in neural tube closure and premature neural crest specification. We demonstrate that elevated BMP4 depletes PSM progenitors in vitro, phenocopying the Fgf3 mutant, suggesting that excessive BMP signals cause the Fgf3 axis defect. To test this in vivo we increased BMP signaling in Fgf3 mutants by removing one copy of Noggin, which encodes a BMP antagonist. In such mutants, all parameters of the Fgf3 phenotype were exacerbated: neural tube closure delay, premature neural crest specification, and premature axis termination. Conversely, genetically decreasing BMP signaling in Fgf3 mutants, via loss of BMP receptor activity, alleviates morphological defects. Aberrant apoptosis is observed in the Fgf3 mutant tailbud. However, we demonstrate that cell death does not cause the Fgf3 phenotype: blocking apoptosis via deletion of pro-apoptotic genes surprisingly increases all Fgf3 defects including causing spina bifida. We demonstrate that this counterintuitive consequence of blocking apoptosis is caused by the increased survival of BMP-producing cells in the neuroepithelium. Thus, we show that FGF3 in the caudal vertebrate embryo regulates BMP signaling in the neuroepithelium, which in turn regulates neural tube closure, neural crest specification and axis termination. Uncovering this FGF3-BMP signaling axis is a major advance toward understanding how these tissue layers interact during axis extension with important implications in human disease. PMID:27144312

Successful Retrieval of an Embolized Vascular Closure Device (Angio-Seal{sup ®}) After Peripheral Angioplasty

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jud, Philipp, E-mail: philipp.jud@medunigraz.at; Portugaller, Rupert; Bohlsen, Dennis

A 55-year-old male with peripheral arterial disease underwent angioplasty of the right lower limb arteries via antegrade femoral access. Angio-Seal{sup ®} closure device was used to treat the puncture site, whereby the intravascular sealing anchor accidentally embolized into the malleolar region of the right posterior tibial artery. Successful retrieval of the anchor was accomplished by a SpiderFX embolic protection device. This technique may be a useful approach to retrieve embolized foreign bodies via endovascular access.

Power spectrum analysis for defect screening in integrated circuit devices

DOEpatents

Tangyunyong, Paiboon; Cole Jr., Edward I.; Stein, David J.

2011-12-01

A device sample is screened for defects using its power spectrum in response to a dynamic stimulus. The device sample receives a time-varying electrical signal. The power spectrum of the device sample is measured at one of the pins of the device sample. A defect in the device sample can be identified based on results of comparing the power spectrum with one or more power spectra of the device that have a known defect status.

Device-less patent foramen ovale closure by radiofrequency thermal energy.

PubMed

Walpoth, Nazan B; Habermacher, Kathrin; Moarof, Igal; Watson, Sandy; Wahl, Andreas; Windecker, Stephan; Schönenberger, Christa; Meier, Bernhard

2008-02-23

The goal of this study was to assess the feasibility, safety and success of a system which uses radiofrequency energy (RFE) rather than a device for percutaneous closure of patent foramen ovale (PFO). Sixteen patients (10 men, 6 women, mean age 50 years) were included in the study. All of them had a proven PFO with documented right-to-left shunt (RLS) after Valsalva manoeuvre (VM) during transoesophageal echocardiography (TEE). The patients had an average PFO diameter of 6 +/- 2 mm at TEE and an average of 23 +/- 4 microembolic signals (MES) in power M-mode transcranial Doppler sonography (pm-TCD), measured over the middle cerebral artery. An atrial septal aneurysm (ASA) was present in 7 patients (44%). Balloon measurement, performed in all patients, revealed a stretched PFO diameter of 8 +/- 3 mm. In 2 patients (stretched diameter 11 and 14 mm respectively, both with ASA >10 mm), radiofrequency was not applied (PFO too large) and the PFO was closed with an Amplatzer PFO occluder instead. A 6-month follow-up TEE was performed in all patients. There were no serious adverse events during the procedure or at follow-up (12 months average). TEE 6 months after the first RFE procedure showed complete closure of the PFO in 50% of the patients (7/14). Closure appeared to be influenced by PFO diameter, complete closure being achieved in 89% (7/8) with a balloon-stretched diameter < or =7 mm but in none of the patients >7 mm. Only one of the complete closure patients had an ASA. Of the remainder, 4 (29%) had an ASA. Although the PFO was not completely closed in this group, some reduction in the diameter of the PFO and in MES was documented by TEE and pm-TCD with VM. Five of the 7 residual shunt patients received an Amplatzer PFO occluder. Except for one patient with a minimal residual shunt, all showed complete closure of PFO at 6-month follow-up TEE and pm-TCD with VM. The other two refused a closure device. The results confirm that radiofrequency closure of the PFO is safe albeit less efficacious and more complex than device closure. The technique in its current state should not be attempted in patients with a balloon-stretched PFO diameter >7 mm and an ASA.

Perineal Hernia Is an Unusual Complication Post Perineal Bladder Neck Closure: A Case Report.

PubMed

Omar, Helmy; Helmy, Tamer E; Hafez, Ashraf T; Dawaba, Mohamed E

2017-03-01

Bladder neck closure (BNC) is the ultimate bladder neck reconstruction. If reconstruction fails, closure must be considered as it gives the highest continence rate. The vast majority of BNCs are performed through an abdominal approach (either transvesical or extravesical approach), but perineal approach remains an option for BNC with considerable success rate. Perineal hernia, which is defined as protrusion of abdominal contents through the perineal defect, is a very rare complication after urologic procedures. We report a case of perineal hernia post perineal BNC. Copyright © 2016 Elsevier Inc. All rights reserved.

Echocardiography for patent ductus arteriosus including closure in adults.

PubMed

Chugh, Reema; Salem, Morris M

2015-01-01

Patent ductus arteriosus (PDA) represents at least 5-10% of all congenital heart defects (CHDs) making it a very important commonly diagnosed lesion. Although spontaneous closure of the PDA occurs within 24 to 48 hours after birth in the majority, those children who do not have natural or surgical closure may have a persistent PDA into adulthood. The diagnosis is most often confirmed by echocardiography that also guides catheter-based interventions and surgeries. Echocardiography continues to be the most important tool in long-term follow-up of residua and sequelae. © 2014, Wiley Periodicals, Inc.

Association of aortic stiffness to brain natriuretic peptide in children before and after device closure of patent ductus arteriosus

PubMed Central

Mahfouz, Ragab A.; Alzaiat, Ahmad; Gad, Marwa

2014-01-01

Objectives We evaluated the influence of device closure for patent ductus arteriosus (PDA) on the aortic stiffness index (ASI) and brain natriuretic peptide (BNP) and their association with cardiac function. Patients and methods ASI and echocardiography assessment before and after treatment (16 ± 9 months) in 48 children with PDA (mean age 10 ± 4.5) and 52 control children (mean age 9.7 ± 4.6). BNP level was measured pre-closure for all children, and was measured six months after closure only for children with PDA. Results ASI was higher in PDA patients than in controls (P < 0.001). ASI correlated with age (P < 0.05), LVEF% (P < 0.01), E/E′ (<0.03), pulmonary artery pressure (P < 0.001), and BNP (P < 0.001). ASI and BNP significantly decreased after closure (P < 0.001). ASI and BNP were independent predictors for post-closure systolic dysfunction (P < 0.001and <0.005, respectively). Receiver operating curve (ROC) analysis showed that ASI ⩾ 13.5, BNP level ⩾75 pg/ml and basal mean pulmonary artery pressure (PAP) ⩾ 23 were powerful predictors for post-closure systolic function. Conclusion ASI is significantly associated with BNP and basal PAP in children with PDA. After device closure, aortic distensibility improved significantly and was associated with significant improvement in both systolic and diastolic functions. ASI can be used for monitoring the course of patients with PDA, and may give opportunities for early intervention. PMID:25544819

Inferior sinus venosus defects: anatomic features and echocardiographic correlates.

PubMed

Plymale, Jennifer; Kolinski, Kellen; Frommelt, Peter; Bartz, Peter; Tweddell, James; Earing, Michael G

2013-02-01

Inferior sinus venosus defects (SVDs) are rare imperfections located in the inferior portion of the atrial septum, leading to an overriding inferior vena cava (IVC) and an interatrial connection. These defects have increased risk of anomalous pulmonary venous return (PAPVR) and often are confused with secundum atrial septal defects (ASDs) with inferior extension. The authors sought to review their experience with inferior SVDs and to establish at their institution an echocardiographic definition that differentiates inferior SVDs from secundum ASDs with inferior extension. The study identified 161 patients 1.5 to 32 years of age who had undergone repair of a secundum ASD with inferior extension or inferior SVD over the preceding 10 years. All surgical notes, preoperative transthoracic echocardiograms (TTEs), and preoperative transesophageal echocardiograms (TEEs) were reviewed. Based on the surgical notes, 147 patients were classified as having a secundum ASD (147/161, 91 %) and 14 patients (9 %) as having an inferior SVD. The study identified PAPVR in 7 % (1/14) of the patients with inferior SVDs and 3.5 % (5/14) of the patients with secundum ASDs. Surgical diagnosis and preoperative TTE correlated for 143 (89 %) of the 161 patients. Using a strict anatomic and echocardiographic definition with a blinded observer, the majority of the defects (14/18, 78 %) were reclassified correctly after review of their TTE images, and 100 % of the defects were correctly reclassified after TEE image review. Accurate diagnosis of inferior SVDs remains challenging. The data from this study demonstrate that use of a strict anatomic and echocardiographic definition (a defect that originates in the mouth of the IVC and continues into the inferoposterior border of the left atrium, leaving no residual atrial septal tissue at the inferior margin) allows for accurate differentiation between secundum ASDs with inferior extension and inferior SVDs. This differentiation is extremely important in planning for surgical versus device closure of these rare defects.

A new, treatable source of recurrent meningitis: basioccipital meningocele.

PubMed

Hemphill, M; Freeman, J M; Martinez, C R; Nager, G T; Long, D M; Crumrine, P

1982-12-01

A 19-month-old boy suffered eight episodes of bacterial meningitis. During the ninth episode a meningocele of the basioccipital clivus communicating with the nasopharynx was discovered. Identification of the organism causing the episodes of meningitis was not helpful in pointing to the site of this congenital anatomic defect. Surgical closure of the defect has prevented further recurrences.

Clinically apparent long-term electric disturbances in the acute and very long-term of patent foramen ovale device-based closure.

PubMed

Rigatelli, Gianluca; Zuin, Marco; Pedon, Luigi; Zecchel, Roberto; Dell'Avvocata, Fabio; Carrozza, Antonio; Zennaro, Marco; Pastore, Gianni; Zanon, Francesco

2017-03-01

Incidence of electrical disturbances in patients submitted to transcatheter patent foramen ovale (PFO) closure has not been fully clarified in a large population. The aim of the study is to assess the incidence of atrial fibrillation, supraventricular tachi-arrhythmias, and atrio-ventricular block in the acute and very long-term follow-up. We reviewed the medical and instrumental data of 1000 consecutive patients (mean age 47.3±17.1years) prospectively enrolled in two centers over a 13-year period (February 1999 to February 2012) for right-to-left (R-to-L) shunt ICE-aided catheter-based closure using different devices. Successful transcatheter PFO closure was achieved in 99.8% of the patients. Implanted devices were: Amplatzer PFO Occluder in 463 patients (46.3%), Amplatzer ASD Cribriform Occluder in 420 patients (42.0%), Premere Occlusion System in 95 patients (9.5%), and Biostar Occluder in 22 patients (2.2%). Postprocedural electrical complications occurred in 5.9% of patients. The only independent predictors of electrophysiological complications were female gender (OR 2.3, 0.5-5.1 [95% CI], p<0.001) and device disk >30mm (OR 5.0, 1.2-7.2 [95% CI], p<0.001). On a mean follow-up of 12 .3±0.6years (minimum 4- maximum 17years), electrical complications occurred in 1.4% of patients including one only case of complete AVB and 5 cases of permanent AF. The only independent predictors were female gender (OR 2.3, 0.5-5.1 [95% CI], p<0.001) and device disk >30mm (OR 5.0, 1.2-7.2 [95% CI], p<0.001). Device-based closure of PFO using different devices, appeared very safe from an electrophysiological point of view with low incidence of electrical disturbances even in the very long-term follow-up. Copyright © 2016 Elsevier Inc. All rights reserved.

Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology).

PubMed

Reddy, Vivek Y; Möbius-Winkler, Sven; Miller, Marc A; Neuzil, Petr; Schuler, Gerhard; Wiebe, Jens; Sick, Peter; Sievert, Horst

2013-06-25

The purpose of this study was to assess the safety and efficacy of left atrial appendage (LAA) closure in nonvalvular atrial fibrillation (AF) patients ineligible for warfarin therapy. The PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that LAA closure with the Watchman device (Boston Scientific, Natick, Massachusetts) was noninferior to warfarin therapy. However, the PROTECT AF trial only included patients who were candidates for warfarin, and even patients randomly assigned to the LAA closure arm received concomitant warfarin for 6 weeks after Watchman implantation. A multicenter, prospective, nonrandomized study was conducted of LAA closure with the Watchman device in 150 patients with nonvalvular AF and CHADS₂ (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, and prior stroke or transient ischemic attack) score ≥1, who were considered ineligible for warfarin. The primary efficacy endpoint was the combined events of ischemic stroke, hemorrhagic stroke, systemic embolism, and cardiovascular/unexplained death. The mean CHADS₂ score and CHA₂DS₂-VASc (CHADS₂ score plus 2 points for age ≥75 years and 1 point for vascular disease, age 65 to 74 years, or female sex) score were 2.8 ± 1.2 and 4.4 ± 1.7, respectively. History of hemorrhagic/bleeding tendencies (93%) was the most common reason for warfarin ineligibility. Mean duration of follow-up was 14.4 ± 8.6 months. Serious procedure- or device-related safety events occurred in 8.7% of patients (13 of 150 patients). All-cause stroke or systemic embolism occurred in 4 patients (2.3% per year): ischemic stroke in 3 patients (1.7% per year) and hemorrhagic stroke in 1 patient (0.6% per year). This ischemic stroke rate was less than that expected (7.3% per year) based on the CHADS₂ scores of the patient cohort. LAA closure with the Watchman device can be safely performed without a warfarin transition, and is a reasonable alternative to consider for patients at high risk for stroke but with contraindications to systemic oral anticoagulation. (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology [ASAP]; NCT00851578). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Improvement of tricuspid regurgitation after transcatheter ASD closure in older patients.

PubMed

Chen, L; Shen, J; Shan, X; Wang, F; Kan, T; Tang, X; Zhao, X; Qin, Y

2017-07-19

Adult patients with undiagnosed atrial septal defect (ASD) may have right heart cavity enlargement and functional tricuspid valve insufficiency. Moderate or more severe tricuspid regurgitation has been associated with a worse prognosis, and more serious complications are typically seen in older patients. This study aimed to evaluate the improvement in functional tricuspid regurgitation and heart geometry after transcatheter ASD closure in older patients. The data of 111 patients over 60 years of age with moderate or severe tricuspid regurgitation before ASD closure were analyzed. At the 1‑month and 6‑month follow-up after closure, both tricuspid regurgitation jet area and right atrial volume decreased significantly. Right ventricular volume decreased 1 month after closure, showing a further decrease at the end of the 6‑month follow-up. However, 24 patients (21.6%) still had persistent severe tricuspid regurgitation after the procedure. Multivariate analysis revealed that patient age at ASD closure and pulmonary artery systolic pressure determined by echocardiography before closure were predictors of persistent tricuspid regurgitation after closure. Transcatheter ASD closure in older patients could significantly decrease tricuspid regurgitation and improve right heart geometry.

The First Dorsal Metatarsal Artery Perforator Propeller Flap.

PubMed

Hallock, Geoffrey G

2016-06-01

Distal foot and toe defects requiring a vascularized flap for coverage have very limited options, oftentimes justifying even a free flap. Perforator flaps in general and propeller flaps in particular have opened up an entirely new subset of local tissue transfer alternatives that can potentially avoid the difficulties that accompany microvascular tissue transfers. The first dorsal metatarsal artery (FDMA) perforator propeller flap represents another variation of this theme. A standard FDMA flap from the dorsum of the foot was raised in reversed fashion based on the distal communicating branch or "perforator" from the plantar foot circulation in 2 patients with great toe defects. All distal skin tissue between this perforator and the defect was kept with the FDMA flap as an attached minor blade, to thereby create an FDMA propeller flap. Salvage of the great toe in both patients was achieved. The benefit of the minor blade of the propeller was to fill a portion of the donor site defect of the traditional FDMA major blade, to permit tension-free donor site closure of the dorsal foot without sequela. The distal-based FDMA flap can be useful as a local flap for coverage of distal foot and toe wounds, but direct donor site closure can be problematic as mirrored by its relative the dorsalis pedis flap. The FDMA perforator propeller flap variation can achieve the same reconstructive goals while simultaneously transferring vascularized tissue into the dorsal foot donor site to thereby minimize the tension if direct closure is possible or minimize the need for a skin graft in this notoriously difficult region.

Increased pulmonary artery pressures during exercise are related to persistent tricuspid regurgitation after atrial septal defect closure.

PubMed

De Meester, Pieter; Van De Bruaene, Alexander; Herijgers, Paul; Voigt, Jens-Uwe; Vanhees, Luc; Budts, Werner

2013-08-01

Although closure of an atrial septal defect type secundum often normalizes right heart dimensions and pressures, mild tricuspid insufficiency might persist. This study aimed at (1) identification of determinants explaining the persistence of tricuspid insufficiency after atrial septal defect closure, and (2) evaluation of functional capacity of patients with persistent mild tricuspid insufficiency. Twenty-five consecutive patients (age 42+17 y) were included from the outpatient clinic of congenital heart disease at the University Hospitals of Leuven. All underwent transthoracic echocardiography, semi-supine bicycle stress echocardiography and cardio-pulmonary exercise testing. Six patients (24%) had mild tricuspid insufficiency (2/4) compared to 19 patients (76%) with no or minimal tricuspid insufficiency ( 1/4) as assessed by semi-quantitative colour Doppler echocardiography. Mann-Whitney U and Fisher's exact tests were performed where applicable. Patients with persistent mild tricuspid insufficiency were significantly older than those with no or minimal tricuspid insufficiency (P = 0.042). At rest, no differences in right heart configuration, mean pulmonary artery pressure or right ventricular function were found. At peak exercise, mean pulmonary artery pressure was significantly higher in patients with mild persistent tricuspid insufficiency (P = 0.026). Peak oxygen uptake was significantly lower in patients with mild persistent tricuspid insufficiency (P = 0.019). Mild tricuspid insufficiency after atrial septal defect repair occurs more frequently in older patients and in patients with higher mean pulmonary artery pressure at peak exercise. In patients with mild tricuspid insufficiency, functional capacity was more reduced. Mild tricuspid insufficiency could be a marker of subclinical persistent pressure load on the right ventricle.

Closure device for lead-acid batteries

DOEpatents

Ledjeff, Konstantin

1983-01-01

A closure device for lead-acid batteries includes a filter of granulated activated carbon treated to be hydrophobic combined with means for preventing explosion of emitted hydrogen and oxygen gas. The explosion prevention means includes a vertical open-end tube within the closure housing for maintaining a liquid level above side wall openings in an adjacent closed end tube. Gases vent from the battery through a nozzle directed inside the closed end tube against an impingement surface to remove acid droplets. The gases then flow through the side wall openings and the liquid level to quench any possible ignition prior to entering the activated carbon filter. A wick in the activated carbon filter conducts condensed liquid back to the closure housing to replenish the liquid level limited by the open-end tube.

Aim44p regulates phosphorylation of Hof1p to promote contractile ring closure during cytokinesis in budding yeast

PubMed Central

Wolken, Dana M. Alessi; McInnes, Joseph; Pon, Liza A.

2014-01-01

Whereas actomyosin and septin ring organization and function in cytokinesis are thoroughly described, little is known regarding the mechanisms by which the actomyosin ring interacts with septins and associated proteins to coordinate cell division. Here we show that the protein product of YPL158C, Aim44p, undergoes septin-dependent recruitment to the site of cell division. Aim44p colocalizes with Myo1p, the type II myosin of the contractile ring, throughout most of the cell cycle. The Aim44p ring does not contract when the actomyosin ring closes. Instead, it forms a double ring that associates with septin rings on mother and daughter cells after cell separation. Deletion of AIM44 results in defects in contractile ring closure. Aim44p coimmunoprecipitates with Hof1p, a conserved F-BAR protein that binds both septins and type II myosins and promotes contractile ring closure. Deletion of AIM44 results in a delay in Hof1p phosphorylation and altered Hof1p localization. Finally, overexpression of Dbf2p, a kinase that phosphorylates Hof1p and is required for relocalization of Hof1p from septin rings to the contractile ring and for Hof1p-triggered contractile ring closure, rescues the cytokinesis defect observed in aim44∆ cells. Our studies reveal a novel role for Aim44p in regulating contractile ring closure through effects on Hof1p. PMID:24451263

New method for maximum mobilization of temporalis muscle flap.

PubMed

Masic, Tarik; Babajic, Emina; Dervisevic, Almir; Hassouba, Mahmoud

2012-01-01

Pedicled temporalis muscle flap presenting a good flap for closing large craniofacial defects. Careful surgeons usually do not mobilize temporalis muscle flap enough to make appropriate use, fully closure, especially if defect exceeds the median line. Temporalis flap was used in 16 patients, ages ranged between 12 and 76. In all cases defect reconstruction was done by useing new method of extending standard temporal muscle flap. During surgical procedure it is very important to keep periosteal elevator in close contact with the bone. Then, there is no risk for pedicle injury. After vascular pedicle is identified elevating temporal muscle has to be continued by releasing the muscle insertion from the coronoid process. By this way, flap length and arc of rotation is increased. The flap remained viable in all instances. Most of the patients experienced no perioperative complications. There was no major complications or mortality as a result of performed procedures. With this division, flap length was increased at least 2 cm wich is enough for covering defects crossing the midline. Instead of using bilateral temporalis muscle flaps for defect closure, unilateral is sufficient. With this extension of the pedicle length now rotation point is not at the level of the zygomatic arch but lower part mandibular neck.

Percutaneous closure of atrial septal defects leads to normalisation of atrial and ventricular volumes

PubMed Central

Teo, Karen SL; Dundon, Benjamin K; Molaee, Payman; Williams, Kerry F; Carbone, Angelo; Brown, Michael A; Worthley, Matthew I; Disney, Patrick J; Sanders, Prashanthan; Worthley, Stephen G

2008-01-01

Background Percutaneous closure of atrial septal defects (ASDs) should potentially reduce right heart volumes by removing left-to-right shunting. Due to ventricular interdependence, this may be associated with impaired left ventricular filling and potentially function. Furthermore, atrial changes post-ASD closure have been poorly understood and may be important for understanding risk of atrial arrhythmia post-ASD closure. Cardiovascular magnetic resonance (CMR) is an accurate and reproducible imaging modality for the assessment of cardiac function and volumes. We assessed cardiac volumes pre- and post-percutaneous ASD closure using CMR. Methods Consecutive patients (n = 23) underwent CMR pre- and 6 months post-ASD closure. Steady state free precession cine CMR was performed using contiguous slices in both short and long axis views through the ASD. Data was collected for assessment of left and right atrial, ventricular end diastolic volumes (EDV) and end systolic volumes (ESV). Data is presented as mean ± SD, volumes as mL, and paired t-testing performed between groups. Statistical significance was taken as p < 0.05. Results There was a significant reduction in right ventricular volumes at 6 months post-ASD closure (RVEDV: 208.7 ± 76.7 vs. 140.6 ± 60.4 mL, p < 0.0001) and RVEF was significantly increased (RVEF 35.5 ± 15.5 vs. 42.0 ± 15.2%, p = 0.025). There was a significant increase in the left ventricular volumes (LVEDV 84.8 ± 32.3 vs. 106.3 ± 38.1 mL, p = 0.003 and LVESV 37.4 ± 20.9 vs. 46.8 ± 18.5 mL, p = 0.016). However, there was no significant difference in LVEF and LV mass post-ASD closure. There was a significant reduction in right atrial volumes at 6 months post-ASD closure (pre-closure 110.5 ± 55.7 vs. post-closure 90.7 ± 69.3 mL, p = 0.019). Although there was a trend to a decrease in left atrial volumes post-ASD closure, this was not statistically significant (84.5 ± 34.8 mL to 81.8 ± 44.2 mL, p = NS). Conclusion ASD closure leads to normalisation of ventricular volumes and also a reduction in right atrial volume. Further follow-up is required to assess how this predicts outcomes such as risk of atrial arrhythmias after such procedures. PMID:19040763

[Lung perfusion studies after percutaneous closure of patent ductus arteriosus using the Amplatzer Duct Occluder in children].

PubMed

Parra-Bravo, José Rafael; Apolonio-Martínez, Adriana; Estrada-Loza, María de Jesús; Beirana-Palencia, Luisa Gracia; Ramírez-Portillo, César Iván

2015-01-01

The closure of patent ductus arteriosus with multiple devices has been associated with a reduction in lung perfusion. We evaluated the pulmonary perfusion after percutaneous closure of patent ductus arteriosus with the Amplatzer Duct Occluder device using perfusion lung scan. Thirty patients underwent successful percutaneous patent ductus arteriosus occlusions using the Amplatzer Duct Occluder device were included in this study. Lung perfusion scans were preformed 6 months after the procedure. Peak flow velocities and protrusion of the device were analyzed by Doppler echocardiography. A left lung perfusion<40% was considered abnormal. The device implantation was successful in all patients. Average perfusion of left lung was 44.7±4.9% (37.8-61.4). Five patients (16.6%) showed decreased perfusion of the left lung. Age, low weight, the length of the ductus arteriosus and the minimum and maximum diameter/length of the ductus arteriosus ratio were statistically significant in patients with abnormalities of lung perfusion. It was observed protrusion the device in 6 patients with a higher maximum flow rate in the left pulmonary artery. The left lung perfusion may be compromised after percutaneous closure of patent ductus arteriosus with the Amplatzer Duct Occluder. The increased flow velocity in the origin of the left pulmonary artery can be a poor indicator of reduction in pulmonary perfusion and can occur in the absence of protrusion of the device. Copyright © 2014 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

Hidden (end-on) patent ductus arteriosus: recognition and device closure.

PubMed

Garg, Naveen; Madan, Bevunahalli Kantharaj

2016-02-01

Sometimes, it is difficult to visualize a patent ductus arteriosus and deploy a device in the standard lateral view because of an end-on orientation. The right anterior oblique view may be helpful by separating the ductus arteriosus from the aorta. This study was undertaken to evaluate the incidence of end-on patent ductus arteriosus and the utility of the right anterior oblique view during device closure. Aortography was performed in lateral and right anterior oblique views before, during, and after successful device deployment in 117 consecutive patients. When a ductus arteriosus was not clearly visible in the lateral view due to overlapping by the aorta, it was termed "right anterior oblique view useful". The types of patent ductus arteriosus were A, B, C, and E in 86 (73.5%), 20 (17.1%), 4 (3.4%), and 7 (6.0%) patients, respectively. An end-on ductus arteriosus was present in 24 (20.5%) patients (14 type B, 10 type A). The right anterior oblique view was useful during device closure in 15 (12.8%) cases (all end-on type). Among all cases of end-on patent ductus arteriosus, it was useful in 62.5% (most type B and a few type A). In all of these, the device appeared obliquely oriented and foreshortened in the lateral view but fully profiled in the right anterior oblique view. Recognizing an end-on patent ductus arteriosus and utilizing the right anterior oblique view simplified device closure. For ducts well-profiled in the lateral view, the right anterior oblique view is unnecessary and avoidable. © The Author(s) 2016.

Intestinal adhesion to the abdominal wall after skin closure with octylcyanoacrylate.

PubMed

Chaya, Miguel; Reyes-Cuervo, Humberto; Cruz, Vivian; Barroso, Gerardo; Garcia-León, Fernando

2004-08-01

Octylcyanoacrylate tissue adhesive glue is a wound closure device recently approved by the U.S. Food and Drug Administration. Few complications have been reported regarding the liquid adhesive entering the wound. The following report involves a patient who developed intestinal occlusion secondary to octylcyanoacrylate used for skin closure in laparoscopic surgery.

Closure of patent ductus arteriosus in children, small infants, and premature babies with Amplatzer duct occluder II additional sizes: multicenter study.

PubMed

Sungur, Metin; Karakurt, Cemsit; Ozbarlas, Nazan; Baspinar, Osman

2013-08-01

To evaluate safety and efficacy of closure of patent ductus arteriosus (PDA) with Amplatzer duct occluder II Additional Sizes (ADO II AS) and to report early and midterm results of the device in children and very young symptomatic infants. Retrospective analysis of angiographic data of 60 children from four pediatric cardiology centers. The median patient age and weight were 6.5 (0.5-168) months and 6.8 (1.19-57) kg, respectively. In the study, 26 children had a body weight of ≤ 6 kg. Of these 26 children, 9 had a body weight of ≤ 3 kg. The median narrowest diameter of PDA was 2 (1.2-4) mm. Ductal anatomy was Type A in 29, Type B in 2, Type C in 11, Type D in 1, and Type E in 16 patients, and a residual PDA after surgery in 1 patient. Closure with ADO II AS was achieved in 58 (96.6%) of 60 attempted cases. In two infants, the device was not released because of significant residual shunt. ADO II was used in one, and the other was sent to surgery. Complete closure was observed in all ADO II AS deployed children by the next day on echocardiography. Median follow-up was 12 (1-18) months. Neither death nor any major complications occurred. Our study shows that closure of medium and small sized PDA by using ADO II AS device is effective and safe in children. The use of the device will expand the field of application of PDA closure in small infants. © 2013 Wiley Periodicals, Inc.

Modeling Anterior Development in Mice: Diet as Modulator of Risk for Neural Tube Defects

PubMed Central

Kappen, Claudia

2014-01-01

Head morphogenesis is a complex process that is controlled by multiple signaling centers. The most common defects of cranial development are craniofacial defects, such as cleft lip and cleft palate, and neural tube defects, such as anencephaly and encephalocoele in humans. More than 400 genes that contribute to proper neural tube closure have been identified in experimental animals, but only very few causative gene mutations have been identified in humans, supporting the notion that environmental influences are critical. The intrauterine environment is influenced by maternal nutrition, and hence, maternal diet can modulate the risk for cranial and neural tube defects. This article reviews recent progress toward a better understanding of nutrients during pregnancy, with particular focus on mouse models for defective neural tube closure. At least four major patterns of nutrient responses are apparent, suggesting that multiple pathways are involved in the response, and likely in the underlying pathogenesis of the defects. Folic acid has been the most widely studied nutrient, and the diverse responses of the mouse models to folic acid supplementation indicate that folic acid is not universally beneficial, but that the effect is dependent on genetic configuration. If this is the case for other nutrients as well, efforts to prevent neural tube defects with nutritional supplementation may need to become more specifically targeted than previously appreciated. Mouse models are indispensable for a better understanding of nutrient–gene interactions in normal pregnancies, as well as in those affected by metabolic diseases, such as diabetes and obesity. PMID:24124024

Percutaneous closure of patent foramen ovale in patients with cryptogenic embolism: a network meta-analysis.

PubMed

Stortecky, Stefan; da Costa, Bruno R; Mattle, Heinrich P; Carroll, John; Hornung, Marius; Sievert, Horst; Trelle, Sven; Windecker, Stephan; Meier, Bernhard; Jüni, Peter

2015-01-07

Up to 40% of ischaemic strokes are cryptogenic. A strong association between cryptogenic stroke and the prevalence of patent foramen ovale (PFO) suggests paradoxical embolism via PFO as a potential cause. Randomized trials failed to demonstrate superiority of PFO closure over medical therapy. Randomized trials comparing percutaneous PFO closure against medical therapy or devices head-to-head published or presented by March 2013 were identified through a systematic search. We performed a network meta-analysis to determine the effectiveness and safety of PFO closure with different devices when compared with medical therapy. We included four randomized trials (2963 patients with 9309 patient-years). Investigated devices were Amplatzer (AMP), STARFlex (STF), and HELEX (HLX). Patients allocated to PFO closure with AMP were less likely to experience a stroke than patients allocated to medical therapy [rate ratio (RR) 0.39; 95% CI: 0.17-0.84]. No significant differences were found for STF (RR 1.01; 95% CI: 0.44-2.41), and HLX (RR, 0.71; 95% CI: 0.17-2.78) when compared with medical therapy. The probability to be best in preventing strokes was 77.1% for AMP, 20.9% for HLX, 1.7% for STF, and 0.4% for medical therapy. No significant differences were found for transient ischaemic attack and death. The risk of new-onset atrial fibrillation was more pronounced for STF (RR 7.67; 95% CI: 3.25-19.63), than AMP (RR 2.14; 95% CI: 1.00-4.62) and HLX (RR 1.33; 95%-CI 0.33-4.50), when compared with medical therapy. The effectiveness of PFO closure depends on the device used. PFO closure with AMP appears superior to medical therapy in preventing strokes in patients with cryptogenic embolism. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

Rationale and design of a randomised clinical trial comparing vascular closure device and manual compression to achieve haemostasis after diagnostic coronary angiography: the Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression (ISAR-CLOSURE) trial.

PubMed

Xhepa, Erion; Byrne, Robert A; Schulz, Stefanie; Helde, Sandra; Gewalt, Senta; Cassese, Salvatore; Linhardt, Maryam; Ibrahim, Tareq; Mehilli, Julinda; Hoppe, Katharina; Grupp, Katharina; Kufner, Sebastian; Böttiger, Corinna; Hoppmann, Petra; Burgdorf, Christof; Fusaro, Massimiliano; Ott, Ilka; Schneider, Simon; Hengstenberg, Christian; Schunkert, Heribert; Laugwitz, Karl-Ludwig; Kastrati, Adnan

2014-06-01

Vascular closure devices (VCD) have been introduced into clinical practice with the aim of increasing the procedural efficiency and clinical safety of coronary angiography. However, clinical studies comparing VCD and manual compression have yielded mixed results, and large randomised clinical trials comparing the two strategies are missing. Moreover, comparative efficacy studies between different VCD in routine clinical use are lacking. The Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression (ISAR-CLOSURE) trial is a prospective, randomised clinical trial designed to compare the outcomes associated with the use of VCD or manual compression to achieve femoral haemostasis. The test hypothesis is that femoral haemostasis after coronary angiography achieved using VCD is not inferior to manual compression in terms of access-site-related vascular complications. Patients undergoing coronary angiography via the common femoral artery will be randomised in a 1:1:1 fashion to receive FemoSeal VCD, EXOSEAL VCD or manual compression. The primary endpoint is the incidence of the composite of arterial access-related complications (haematoma ≥5 cm, pseudoaneurysm, arteriovenous fistula, access-site-related bleeding, acute ipsilateral leg ischaemia, the need for vascular surgical/interventional treatment or documented local infection) at 30 days after randomisation. According to power calculations based on non-inferiority hypothesis testing, enrolment of 4,500 patients is planned. The trial is registered at www.clinicaltrials.gov (study identifier: NCT01389375). The safety of VCD as compared to manual compression in patients undergoing transfemoral coronary angiography remains an issue of clinical equipoise. The aim of the ISAR-CLOSURE trial is to assess whether femoral haemostasis achieved through the use of VCD is non-inferior to manual compression in terms of access-site-related vascular complications.

Intracardiac echo-guided radiofrequency catheter ablation of atrial fibrillation in patients with atrial septal defect or patent foramen ovale repair: a feasibility, safety, and efficacy study.

PubMed

Lakkireddy, Dhanunjaya; Rangisetty, Umamahesh; Prasad, Subramanya; Verma, Atul; Biria, Mazda; Berenbom, Loren; Pimentel, Rhea; Emert, Martin; Rosamond, Thomas; Fahmy, Tamer; Patel, Dimpi; Di Biase, Luigi; Schweikert, Robert; Burkhardt, David; Natale, Andrea

2008-11-01

Intracardiac Echo-Guided Radiofrequency Catheter. Patients with atrial septal defect (ASD) are at higher risk for atrial fibrillation (AF) even after repair. Transseptal access in these patients is perceived to be difficult. We describe the feasibility, safety, and efficacy of pulmonary vein antral isolation (PVAI) in these patients. We prospectively compared post-ASD/patent foramen ovale (PFO) repair patients (group I, n = 45) with age-gender-AF type matched controls (group II, n = 45). All the patients underwent PVAI through a double transseptal puncture with a roving circular mapping catheter technique guided by intracardiac echocardiography (ICE). The short-term (3 months) and long-term (12 month) failure rates were assessed. In group I, 23 (51%) had percutaneous closure devices and 22 (49%) had a surgical closure. There was no significant difference between group I and II in the baseline characteristics. Intracardiac echo-guided double transseptal access was obtained in 98% of patients in group I and in 100% of patients in group II. PVAI was performed in all patients, with right atrial flutter ablation in 7 patients in group I and in 4 patients in group II. Over a mean follow-up of 15 +/- 4 months, group I had higher short-term (18% vs 13%, P = 0.77) and long-term recurrence (24% vs 18%, P = 0.6) than group II. There was no significant difference in the perioperative complications between the two groups. Echocardiography at 3 months showed interatrial communication in 2 patients in group I and 1 patient in group II, which resolved at 12 months. Percutaneous AF ablation using double transseptal access is feasible, safe, and efficacious in patients with ASD and PFO repairs.

Comparison of three patent foramen ovale closure devices in a randomized trial (Amplatzer versus CardioSEAL-STARflex versus Helex occluder).

PubMed

Taaffe, Margaret; Fischer, Evelyn; Baranowski, Andreas; Majunke, Nicolas; Heinisch, Corinna; Leetz, Michaela; Hein, Ralph; Bayard, Yves; Büscheck, Franziska; Reschke, Madlen; Hoffmann, Ilona; Wunderlich, Nina; Wilson, Neil; Sievert, Horst

2008-05-01

This randomized trial compared procedural complications and 30-day clinical outcomes of 3 patent foramen ovale (PFO) closure devices (Amplatzer, Helex, and CardioSEAL-STARflex). It examined 660 patients (361 men, 299 women, mean age 49.3+/-1.9 years), with 220 patients per group. All patients had a history of paradoxical embolism. All PFO closures were successful technically. Exchange of devices for others was most frequently required for the Helex occluder (7 of 220) and 2 of 220 in either of the other groups. Three device embolizations in the Helex group were retrieved and replaced successfully. One patient with a Helex occluder developed a transient ischemic attack and recovered without treatment. A hemopericardium in that group was punctured without affecting the device. One tamponade in the Amplatzer group required surgical device explantation. In 8 of 660 patients in the CardioSEAL-STARflex group, thrombi resolved after anticoagulation. Sixteen patients (11 in the CardioSEAL-STARflex group, 3 in the Amplatzer group, and 2 in the Helex group) had episodes of atrial fibrillation. PFOs were closed completely in 143 of 220 patients (65%) in the Amplatzer group, 116 of 220 patients (52.7%) in the Helex group, and 137 of 220 patients (62.3%) in the CardioSEAL-STARflex group at 30 days with significant differences between the Helex and Amplatzer occluders (p=0.0005) and the Helex and CardioSEAL-STARflex occluders (p=0.0003). PFO closure can be performed safely with each device. In conclusion, the Helex occluder embolized more frequently. Device thrombus formation and paroxysmal atrial fibrillation were more common with the CardioSEAL-STARflex occluder.

Metabolite Profiling of Whole Murine Embryos Reveals Metabolic Perturbations Associated with Maternal Valproate-Induced Neural Tube Closure Defects

PubMed Central

Akimova, Darya; Wlodarczyk, Bogdan J.; Lin, Ying; Ross, M. Elizabeth; Finnell, Richard H.; Chen, Qiuying; Gross, Steven S.

2016-01-01

Background Valproic Acid (VPA) is prescribed therapeutically for multiple conditions, including epilepsy. When taken during pregnancy, VPA is teratogenic, increasing the risk of several birth and developmental defects including neural tube defects (NTDs). The mechanism by which VPA causes NTDs remains controversial and how VPA interacts with folic acid, a vitamin commonly recommended for the prevention of NTDs, remains uncertain. We sought to address both questions by applying untargeted metabolite profiling analysis to neural tube closure stage mouse embryos. Methods Pregnant SWV dams on either a 2ppm or 10ppm folic acid (FA) supplemented diet were injected with a single dose of VPA on gestational day E8.5. On day E9.5, the mouse embryos were collected and evaluated for neural tube closure status. LC/MS metabolomics analysis was performed to compare metabolite profiles of NTD-affected VPA-exposed whole mouse embryos to profiles from embryos that underwent normal neural tube closure from control dams. Results NTDs were observed in all embryos from VPA-treated dams and penetrance was not diminished by dietary folic acid supplementation. The most profound metabolic perturbations were found in the 10ppm FA VPA-exposed mouse embryos, compared to the other three treatment groups. Affected metabolites included amino acids, nucleobases and related phosphorylated nucleotides, lipids, and carnitines. Conclusions Maternal VPA treatment markedly perturbed purine and pyrimidine metabolism in E9.5 embryos. In combination with a high folic acid diet, VPA treatment resulted in gross metabolic changes, likely caused by a multiplicity of mechanisms, including an apparent disruption of mitochondrial beta-oxidation. PMID:27860192

Biomechanical Testing and Histologic Examination of Intradermal Skin Closure in Dogs Using Barbed Suture Device and Non-Barbed Monofilament Suture.

PubMed

Law, Andy Y; Butler, James R; Patnaik, Sourav S; Cooley, James A; Elder, Steven H

2017-01-01

To compare the biomechanical strength and histologic features of 3-0 Glycomer™ 631 barbed suture (V-LOC™ 90 Absorbable Wound Closure Device, Covidien, Mansfield, MA) to non-barbed 3-0 Glycomer™ 631 suture (Biosyn™, Covidien) for intradermal skin wound closure in the dog. Randomized, factorial, in vivo. Eighteen purpose-bred, mature male, and female hound dogs. Eighteen adult hound dogs were randomly assigned to 1 of 3 groups designated by postoperative day of assessment. Six skin incisions were made along the dorsum in the thoracolumbar region of each dog with an equal number (n=3) randomly assigned to closure with barbed or non-barbed suture. Six dogs were euthanatized on postoperative days 3, 10, and 14, respectively. Two additional incisions were made on each dog after euthanasia for baseline data (Day 0). The skin incision specimens were harvested for biomechanical testing and histologic evaluation. Non-barbed closure had significantly higher maximum load at failure (P<.001) and stiffness (P<.001) than barbed closure regardless of day. The average tissue reaction score was significantly higher for barbed closure (P=.008), regardless of day. Suturing time for barbed closures was significantly shorter. There was no significant difference in frequency of complications between closures. Barbed Glycomer™ 631 closures had a significantly lower maximum load at failure and stiffness, and higher average tissue reaction scores, but showed no difference in short term outcome for intradermal closure of dorsally located skin incisions in dogs. © 2016 The American College of Veterinary Surgeons.

The relation between atrial septal defect shape, diameter, and area using three-dimensional transoesophageal echocardiography and balloon sizing during percutaneous closure in children.

PubMed

Hascoet, Sébastien; Hadeed, Khaled; Marchal, Pauline; Dulac, Yves; Alacoque, Xavier; Heitz, Francois; Acar, Philippe

2015-07-01

A trans-catheter closure of an atrial septal defect (ASD) is efficient. Balloon sizing (BS) during the catheterization leads to an overestimation of ASD size. Three-dimensional transoesophageal echocardiography (3D-TEE) allows the ASD morphology to be assessed comprehensively. The aim of this study was to assess the relationships between the shape and the measurements of ASDs by 2D-, 3D-TEE, and BS in children. Thirty children who underwent percutaneous closures of a single ASD were enrolled. ASD diameters were measured by 2D-transthoracic echocardiography (TTE), 2D-TEE, 3D-TEE and compared with BS. The ASD area was measured on 3D-TEE images after multi-planar reconstruction. ASD was estimated as round or oval on 3D-TEE 'en-face' view. 2D-TTE, 2D-TEE, and 3D-TEE(max) ASD diameters were well correlated with BS (r = 0.75; 0.80, and 0.85, respectively). Mean diameters were all significantly smaller than the mean BS. The mean difference between the balloon area and 3D-TEE area was 1.6 ± 1.4 cm(2) (P < 0.0001). The mean difference between BS and 3D-TEE(max) diameters was higher in round ASDs than in oval ASDs (4.0 ± 3.3 vs. 1.1 ± 3.3, P = 0.02). With multivariate linear regression analysis, two formulas were built to predict BS. The first model was BS = 1.07 × 3D-TEE(max)- 3.1 × ASDshape + 3. The ASD shape was 0 for round and 1 for oval ASDs. A second model was BS = 4.5 × ASDarea + 11.5. The ASD shape is accurately estimated by 3D-TEE and influences the relationship between echocardiographic measurements and BS. The ASD shape, its maximal diameter and the area assessed by 3D-TEE may be sufficient to determine the device size without BS in children. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Device for temporarily closing duct-formers in well completion apparatus

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zandmer, H.M.; Zandmer, S.M.

A duct-forming device is disclosed for use in a well completion apparatus of the kind, wherein a bore hole casing is positioned in a bore hole and duct-forming devices of alkali- and acid resistant metal-such as steel-are secured at spaced levels to the casing in alignment with holes machined in the casing wall. In accordance with the invention, a closure device is arranged within the duct-forming device which permits flow of predetermined amounts of liquid, such as acid, from the interior of the casing through the duct-forming device and into the producing formation, while gradually being moved by the liquidmore » into a position in which such fluid flow is prevented. After the fluid flow has been stopped by the closure device and when the formation pressure exceeds the pressure within the duct-forming device and the casing, fluid from the formation then forces the closure device toward and into the casing space to permit thereafter free flow of formation fluid into the duct-forming device and the casing or of pressurized treatment liquid from the casing into the formation. The inventive arrangement permits inter alia the establishment of a sufficient and substantially uniform feeding rate of treatment liquid, such as acid, from the casing into the producing formation through all the duct-formers in preparation for subsequent acidification or other treatments, such as sand fracking.« less

Reconstructive methods in Mohs micrographic surgery in Uruguay: A bidirectional descriptive cohort analysis.

PubMed

Navarrete, J; Magliano, J; Martínez, M; Bazzano, C

2018-04-01

The primary goal of Mohs micrographic surgery (MMS) is to completely excise a cancerous lesion and a wide range of reconstructive techniques of varying complexity are used to close the resulting wound. In this study, we performed a descriptive analysis of patients who underwent MMS, with a focus on wound closure methods. We conducted a bidirectional descriptive cohort analysis of all MMS procedures performed by a single surgeon between November 2013 and April 2016. Cosmetic outcomes were photographically assessed by a dermatologist after a minimum follow-up of 90 days. We analyzed 100 MMS procedures in 71 patients with a median age of 73 years. The tumors were basal cell carcinoma (70%), squamous cell carcinoma (29%), and dermatofibrosarcoma protuberans (1%); 75% were located on the head and neck. The reconstructive techniques used were flap closure (48%), simple closure (36%), closure by second intention (11%), and other (5%). Cosmetic outcomes were assessed for 70 procedures (47 patients) and the results were rated as excellent in 20% of cases, very good in 40%, good in 20%, moderate in 17%, and bad/very bad in 2.9%. No significant associations were observed between cosmetic outcome and sex, Fitzpatrick skin type, hypertension, diabetes mellitus, or smoking. Worse outcomes, however, were significantly associated with larger tumor areas and defects, location on the trunk, and flap and second-intention closure. Although there was a tendency to use simple wound closure for lesions located on the trunk and surgical defects of under 4.4cm 2 , the choice of reconstructive technique should be determined by individual circumstances with contemplation of clinical and tumor-related factors and the preference and experience of the surgeon. Copyright © 2017 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.

Prevalence of treatment, risk factors, and management of atrial septal defects in a pediatric Medicaid cohort.

PubMed

Shuler, C Osborne; Tripathi, Avnish; Black, George B; Park, Yong-Moon Mark; Jerrell, Jeanette M

2013-10-01

Atrial septal defects (ASDs) vary greatly depending on their size, age at closure, and clinical management. This report characterizes the prevalence, complexity, and clinical management of these lesions in a statewide pediatric cohort and examines predictors for receiving closures. A 15-year Medicaid data set (1996-2010) from one state was analyzed. The selection criteria specified patients 17 years of age or younger with a diagnosis of ASD primum, secundum, or sinus venosus on one or more service visits to a pediatrician or pediatric cardiologist. During the 15-year period, ASDs represented a prevalence rate for treatment of 0.47/1000 CHDs identified, with 61 % presenting as complex lesions. Concomitant cardiac anomalies that might have a negative impact on prognosis were present including patent ductus arteriosus (26.1 %), pulmonary hypertension (3.8 %), and supraventricular tachycardia (2.4 %). Pharmacologic treatments, predominantly diuretics, were prescribed for 21 % of the cohort. Both surgical closures (6.3 %) and transcatheter closures (1.4 %) were used for ASD secundum cases, whereas surgical closures predominated for ASD primum (25.6 %) and sinus venosus (13.5 %) lesions. The postoperative follow-up period was two to three times longer for children with ASD primum or sinus venosus than for those with ASD secundum (average, ~1 year). Factors predicting the likelihood of having ASD closure were older age, having a concomitant patent ductus arteriosus (PDA) repair, treatment with ibuprofen, having two or more concomitant CHDs, and receiving diuretics or preload/afterload-reducing agents. Care of ASDs in routine practice settings involves more complications and appears to be more conservative than portrayed in previous investigations of isolated ASDs.

Cost-Effectiveness of Percutaneous Closure of the Left Atrial Appendage in Atrial Fibrillation Based on Results From PROTECT AF Versus PREVAIL.

PubMed

Freeman, James V; Hutton, David W; Barnes, Geoffrey D; Zhu, Ruo P; Owens, Douglas K; Garber, Alan M; Go, Alan S; Hlatky, Mark A; Heidenreich, Paul A; Wang, Paul J; Al-Ahmad, Amin; Turakhia, Mintu P

2016-06-01

Randomized trials of left atrial appendage (LAA) closure with the Watchman device have shown varying results, and its cost effectiveness compared with anticoagulation has not been evaluated using all available contemporary trial data. We used a Markov decision model to estimate lifetime quality-adjusted survival, costs, and cost effectiveness of LAA closure with Watchman, compared directly with warfarin and indirectly with dabigatran, using data from the long-term (mean 3.8 year) follow-up of Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation (PROTECT AF) and Prospective Randomized Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation (PREVAIL) randomized trials. Using data from PROTECT AF, the incremental cost-effectiveness ratios compared with warfarin and dabigatran were $20 486 and $23 422 per quality-adjusted life year, respectively. Using data from PREVAIL, LAA closure was dominated by warfarin and dabigatran, meaning that it was less effective (8.44, 8.54, and 8.59 quality-adjusted life years, respectively) and more costly. At a willingness-to-pay threshold of $50 000 per quality-adjusted life year, LAA closure was cost effective 90% and 9% of the time under PROTECT AF and PREVAIL assumptions, respectively. These results were sensitive to the rates of ischemic stroke and intracranial hemorrhage for LAA closure and medical anticoagulation. Using data from the PROTECT AF trial, LAA closure with the Watchman device was cost effective; using PREVAIL trial data, Watchman was more costly and less effective than warfarin and dabigatran. PROTECT AF enrolled more patients and has substantially longer follow-up time, allowing greater statistical certainty with the cost-effectiveness results. However, longer-term trial results and postmarketing surveillance of major adverse events will be vital to determining the value of the Watchman in clinical practice. © 2016 American Heart Association, Inc.

Long-term outcomes of patent foramen ovale closure or medical therapy after cryptogenic stroke: A meta-analysis of randomized trials.

PubMed

Abdelaziz, Hesham K; Saad, Marwan; Abuomara, Hossamaldin Z; Nairooz, Ramez; Pothineni, Naga Venkata K; Madmani, Mohamed E; Roberts, David H; Mahmud, Ehtisham

2018-05-04

To examine long-term clinical outcomes with transcatheter patent foramen ovale (PFO) closure versus medical therapy alone in patients with cryptogenic stroke. A long-standing debate regarding the optimal approach for the management of patients with PFO after a cryptogenic stroke exists. An electronic search was performed for randomized clinical trials (RCTs) reporting clinical outcomes with PFO closure vs. medical therapy alone after stroke. Random effects DerSimonian-Laird risk ratios (RR) were calculated. The main outcome was recurrence of stroke. Other outcomes included transient ischemic attack (TIA), new-onset atrial fibrillation/flutter (AF/AFL), major bleeding, serious adverse events, and device-related complications. All-cause mortality was also examined. Five RCTs with a total of 3,440 patients were included. At a mean follow-up of 4.02 ± 1.57 years, PFO closure was associated with less recurrence of stroke (RR = 0.43; 95% CI 0.19-0.91; P = .027) compared with medical therapy alone. No difference was observed between both strategies for TIA (P = .21), major bleeding (P = .69), serious adverse events (P = .35), and all-cause death (P = .48). However, PFO closure, was associated with increased new-onset AF/AFL (P < .001), risk of pulmonary embolism (P = .04), and device-related complications (P < .001). On a subgroup analysis, stroke recurrence rate remained lower in PFO closure arm regardless of the type of closure device used (P interaction  = .50), or the presence of substantial shunt in the majority of study population (P interaction  = .13). Transcatheter PFO closure reduces the recurrence of stroke compared with medical therapy alone, with no significant safety concerns. Close follow-up of patients after PFO closure is recommended to detect new-onset atrial arrhythmias. © 2018 Wiley Periodicals, Inc.

Innovative real CSF leak simulation model for rhinology training: human cadaveric design.

PubMed

AlQahtani, Abdulaziz A; Albathi, Abeer A; Alhammad, Othman M; Alrabie, Abdulkarim S

2018-04-01

To study the feasibility of designing a human cadaveric simulation model of real CSF leak for rhinology training. The laboratory investigation took place at the surgical academic center of Prince Sultan Military Medical City between 2016 and 2017. Five heads of human cadaveric specimens were cannulated into the intradural space through two frontal bone holes. Fluorescein-dyed fluid was injected intracranialy, then endoscopic endonasal iatrogenic skull base defect was created with observation of fluid leak, followed by skull base reconstruction. The outcome measures included subjective assessment of integrity of the design, the ability of creating real CSF leak in multiple site of skull base and the possibility of watertight closure by various surgical techniques. The fluid filled the intradural space in all specimens without spontaneous leak from skull base or extra sinus areas. Successfully, we demonstrated fluid leak from all areas after iatrogenic defect in the cribriform plate, fovea ethmoidalis, planum sphenoidale sellar and clival regions. Watertight closure was achieved in all defects using different reconstruction techniques (overly, underlay and gasket seal closure). The design is simulating the real patient with CSF leak. It has potential in the learning process of acquiring and maintaining the surgical skills of skull base reconstruction before direct involvement of the patient. This model needs further evaluation and competence measurement as training tools in rhinology training.

Cyanoacrylate medical glue application in intervertebral disc annulus defect repair: Mechanical and biocompatible evaluation.

PubMed

Kang, Ran; Li, Haisheng; Lysdahl, Helle; Quang Svend Le, Dang; Chen, Menglin; Xie, Lin; Bünger, Cody

2017-01-01

In an attempt to find an ideal closure method during annulus defect repair, we evaluate the use of medical glue by mechanical and biocompatible test. Cyanoacrylate medical glue was applied together with a multilayer microfiber/nanofiber polycaprolactone scaffold and suture in annulus repair. Continuous axial loading and fatigue mechanical test was performed. Furthermore, the in vitro response of mesenchymal stem cell (MSC) to the glue was evaluated by cell viability assay. The in vivo response of annulus tissue to the glue and scaffold was also studied in porcine lumbar spine; histological sections were evaluated after 3 months. Cyanoacrylate glue significantly improved the closure effect in the experimental group with failure load 2825.7 ± 941.6 N, compared to 774.1 ± 281.3 N in the control group without glue application (p < 0.01). The experimental group also withstood the fatigue test. No toxic effect was observed by in vitro cell culture and in vivo implantation. On the basis of this initial evaluation, the use of cyanoacrylate medical glue improves closure effect with no toxicity in annulus defect repair. This method of annulus repair merits further effectiveness study in vivo. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 14-20, 2017. © 2015 Wiley Periodicals, Inc.

Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients.

PubMed

de Andrade, Pedro Beraldo; E Mattos, Luiz Alberto Piva; Tebet, Marden André; Rinaldi, Fábio Salerno; Esteves, Vinícius Cardozo; Nogueira, Ederlon Ferreira; França, João Ítalo Dias; de Andrade, Mônica Vieira Athanazio; Barbosa, Robson Alves; Labrunie, André; Abizaid, Alexandre Antônio Cunha; Sousa, Amanda Guerra de Moraes Rego

2013-12-18

Arterial access is a major site of bleeding complications after invasive coronary procedures. Among strategies to decrease vascular complications, the radial approach is an established one. Vascular closure devices provide more comfort to patients and decrease hemostasis and need for bed rest. However, the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications, requiring evidence through adequately designed randomized trials. The aim of this study is to compare the radial versus femoral approach using a vascular closure device for the incidence of arterial puncture site vascular complications among non-ST-segment elevation acute coronary syndrome patients submitted to an early invasive strategy. ARISE is a national, multicenter, non-inferiority randomized clinical trial. Two hundred patients with non-ST-segment elevation acute coronary syndrome will be randomized to either radial or femoral access using a vascular closure device. The primary outcome is the occurrence of vascular complications at an arterial puncture site 30 days after the procedure, including major bleeding, retroperitoneal hematoma, compartment syndrome, hematoma ≥ 5 cm, pseudoaneurysm, arterio-venous fistula, infection, limb ischemia, arterial occlusion, adjacent nerve injury or the need for vascular surgical repair. Enrollment was initiated in September 2012, and until October 2013 91 patients were included. The inclusion phase is expected to last until the second half of 2014. The ARISE trial will help define the role of a vascular closure device as a bleeding avoidance strategy in patients with NSTEACS. ClinicalTrials.gov identifier: NCT01653587.

Percutaneous closure of patent foramen ovale without echocardiographic guidance.

PubMed

Jamshidi, Peiman; Wahl, Andreas; Windecker, Stephan; Schwerzmann, Markus; Seiler, Christian; Meier, Bernhard

2007-01-01

A percutaneous patent foramen ovale (PFO) closure procedure includes transesophageal or intracardiac echocardiographic guidance at many centers. We investigated the feasibility and complications of the PFO closure without echocardiography. A total of 420 consecutive patients (185 women and 235 men, mean age 51 +/- 12 years) underwent percutaneous PFO closure without echocardiographic guidance using 7 different devices. Of these, 106 patients (25%) had an associated atrial septal aneurysm. The implantation was successful in 418 patients (99%). There were 12 procedural complications (3%), including embolization of the device or of parts of it with successful percutaneous removal in 5 cases, pericardial tamponade requiring pericardiocentesis in 1 patient, air embolism with transient symptoms in 3 patients, and vascular access problems in 3 patients. In none of the cases, echocardiography had to be summoned during the case or its lack was associated with acute or subsequent problems. The fluoroscopy time and procedure time were 5.4 +/- 2.7 and 25 +/- 17 minutes, respectively. Transthoracic contrast echocardiography, 24 hours after device implantation, detected a residual shunt in 19% of the patients. Percutaneous PFO closure with fluoroscopic guidance only is feasible and has low complication rates, especially with Amplatzer PFO Occluders. The added time and cost of echocardiography during the procedure is not warranted.

Catheter closure of patent foramen ovale in patients with cryptogenic cerebrovascular accidents: initial experiences in Japan.

PubMed

Kijima, Yasufumi; Akagi, Teiji; Nakagawa, Koji; Taniguchi, Manabu; Ueoka, Akira; Deguchi, Kentaro; Toh, Norihisa; Oe, Hiroki; Kusano, Kengo; Sano, Shunji; Ito, Hiroshi

2014-01-01

Although numerous studies have shown an association between a patent foramen ovale (PFO) and cryptogenic cerebrovascular accidents (CVA), there has been no definitive control study that demonstrated the benefit of percutaneous device closure of a PFO compared to medical therapy in patients with CVA. Additionally, few clinical data exist for Japanese patients in this field. We demonstrate the initial experiences in catheter closure of a PFO as secondary prevention of CVA in Japan. Catheter closure of a PFO was attempted in 7 patients who were diagnosed with cryptogenic CVA. Mean age at the procedure was 54 ± 19 years. The presence of spontaneous interatrial right-to-left shunts was demonstrated by transesophageal contrast echocardiography without Valsalva maneuver in all of the patients. Amplatzer Cribriform device (n = 4) or Amplatzer PFO Occluder (n = 3) was used for the procedure and was successfully deployed. Device-related complications were not observed at the time of the procedure or during the follow-up period (mean period of 16 ± 9 months). Catheter closure of a PFO could be safely performed with Amplatzer Cribriform or Amplatzer PFO Occluder. This procedure may contribute to prevention of recurrent cryptogenic CVA in Japanese patients.

Stent-Grafts in the Management of Hemorrhagic Complications Related to Hemostatic Closure Devices: Report of Two Cases

DOE Office of Scientific and Technical Information (OSTI.GOV)

Giansante Abud, Daniel; Mounayer, Charbel; Saint-Maurice, Jean Pierre

We report 2 cases of hemorrhagic complications related to use of the Angio-Seal hemostatic closure device that were successfully managed with stent-grafts. Two patients with subarachnoid hemorrhage were referred to our departments for endovascular treatment of ruptured intracranial aneurysms. The treatment was performed through a femoral access; the sheaths were removed immediately after the procedures, and the punctures sites closed by Angio-Seals. Both patients presented clinical signs of hypovolemic shock after treatment. The diagnosis of active bleeding through the puncture site was made by emergency digital subtraction angiography. The lesions were managed with stent-grafts. The use of stent-grafts proved tomore » be efficient in the management of these life-threatening hemorrhagic complications following the use of the Angio-Seal hemostatic closure device.« less

Radiation-induced impairment of osseous healing: Quantitative studies usine a standard drilling defect in rat femur

DOE Office of Scientific and Technical Information (OSTI.GOV)

Arnold, M.; Kummermehr, J.; Trott, K.R.

1995-07-01

The femora of adult Wistar rats were locally irradiated with single doses of X rays and 1 day later were wounded by a standardized drilling defect that extended through the diaphyseal cortex into the marrow cavity. Healing of the lesion was followed over 30 weeks to assess the time course of osseous closure. In unirradiated bones healing was complete by week 7. Irradiation with doses up to 15 Gy imparted a dose-dependent delay in the formation of primary callus and its subsequent replacement by more mature bone, while after higher doses healing doses healing remained permanently comprised or even suppressed.more » Using histomorphometry, osseous closure was also measured quantitatively for healing periods of 7, 10, 16 and 30 weeks and the data were expressed as the percentage of responders with {ge}40% fractional closure. the resulting dose-response curves were steep, displaying a large threshold dose and ED{sub 50} values between 16.8 to 17.5 Gy (7 to 16 weeks) and 19.4 Gy (30 weeks), respectively. 35 refs., 4 figs., 2 tabs.« less

The Boomerang-shaped Pectoralis Major Musculocutaneous Flap for Reconstruction of Circular Defect of Cervical Skin

PubMed Central

Azuma, Shuchi; Arikawa, Masaki

2017-01-01

Summary: We report on a patient with a recurrence of oral cancer involving a cervical lymph node. The patient’s postexcision cervical skin defect was nearly circular in shape, and the size was about 12 cm in diameter. The defect was successfully reconstructed with a boomerang-shaped pectoralis major musculocutaneous flap whose skin paddle included multiple intercostal perforators of the internal mammary vessels. This flap design is effective for reconstructing an extensive neck skin defect and enables primary closure of the donor site with minimal deformity. PMID:29263975

Limited access atrial septal defect closure and the evolution of minimally invasive surgery.

PubMed

Izzat, M B; Yim, A P; El-Zufari, M H

1998-04-01

While minimizing the "invasiveness" in general surgery has been equated with minimizing "access", what constitutes minimally invasive intra-cardiac surgery remains controversial. Many surgeons doubt the benefits of minimizing access when the need for cardiopulmonary bypass cannot be waived. Recognizing that median sternotomy itself does entail significant morbidity, we investigated the value of alternative approaches to median sternotomy using atrial septal defect closure as our investigative model. We believe that some, but not all minimal access approaches are associated with reduced postoperative morbidity and enhanced recovery. Our current strategy is to use a mini-sternotomy approach in adult patients, whereas conventional median sternotomy remains our standard approach in the pediatric population. Considerable clinical experiences coupled with documented clinical benefits are fundamental before a certain approach is adopted in routine practice.

No patch technique for complete atrioventricular canal repair.

PubMed

Aramendi, José Ignacio; Rodriguez, Miguel Angel; Luis, Teresa; Voces, Roberto

2006-08-01

We describe our initial experience with a new technique, consisting in direct closure of the ventricular septal defect component of the AV canal, by directly attaching the common bridging leaflets to the crest of the ventricular septum with interrupted sutures. After closure of the cleft, the ostium primum defect was closed with a running suture suturing the border of the septum primum to the newly created AV valve annulus. Three patients were operated upon. There was no mortality. Mean ischemic time was 39 min and mean pump time 77 min. All patients remained in sinus rhythm. At follow-up only trivial or mild mitral regurgitation was observed. This new technique permits the repair of complete AV canal without the need for any patch. It is fast, simple and reproducible.

Transient left ventricular systolic dysfunction following surgical closure of large patent ductus arteriosus among children and adolescents operated at the cardiac centre, Ethiopia.

PubMed

Tilahun, Birkneh; Tefera, Endale

2013-05-31

Patent ductus arteriosus (PDA) is one of the commonest congenital heart diseases that require closure within the first few months after birth. The residential area of patients affects the size of the PDA: living in highlands, like most places in Ethiopia, is a risk for having larger sized PDA. Closure of these congenital heart defects is usually performed at an early age in places where capable centers are available. In Ethiopia, closure of these defects is done on mission basis often at an older age. Recently, limited reports came about the occurrence of postoperative left ventricular systolic dysfunction (POLVD) following closure of PDA though full explanation is still lacking. To determine the rate of and time to improvement of POLVD and the factors associated with it in children and adolescents who underwent surgical closure of PDA. All children and adolescents who underwent surgical closure of PDA at the Cardiac Center, Ethiopia (CCE) had postoperative follow up with echocardiography. Serial left ventricular ejection fraction (LVEF) and fiber shortening (FS) values were recorded for all of them. SPSS 20 was used to analyze the data. A total of 36 children and adolescents who underwent surgical closure of PDA from January 2009 to December 2012 and who fulfilled the inclusion criteria were studied. Their mean age at intervention was 8.52 years (SD = 5.23 years), 77.80% were females. The mean duct size as determined by either echocardiography or intra-operative by the surgeon was 10.31 mm (SD = 3.20 mm). They were followed for a mean duration of 24.80 months (SD = 12.36 months) following surgical closure of PDA. The mean LVEF and FS decreased from 65.06% and 35.28% preoperatively to 54.83% and 28.40% post-operatively respectively. Fifteen (42.86%) of the patients had a post-operative LVEF of less than 55%. The mean time to normalization of systolic function was 5.11 weeks (SD = 3.30 weeks). Having an associated cardiac lesion was an independent predictor of POLVD. We conclude that there is a high rate of POLVD following surgical closure of large PDA in highlanders. We recommend a serial and systematic follow up of these children postoperatively. Those with a significant cardiac dysfunction may need cardiac medications like Angiotensin Converting Enzyme Inhibitors (ACEI).

Patient Satisfaction After Femoral Arterial Access Site Closure Using the ExoSeal{sup ®} Vascular Closure Device Compared to Manual Compression: A Prospective Intra-individual Comparative Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pieper, Claus Christian, E-mail: claus.christian.pieper@ukb.uni-bonn.de; Thomas, Daniel, E-mail: daniel.thomas@ukb.uni-bonn.de; Nadal, Jennifer, E-mail: jennifer.nadal@ukb.uni-bonn.de

PurposeTo intra-individually compare discomfort levels and patient satisfaction after arterial access closure using the ExoSeal{sup ®} vascular closure device (VCD) and manual compression (MC) in a prospective study design.MethodsPatients undergoing two planned interventions from 07/2013 to 09/2014 could participate in the study. Access closure was performed with an ExoSeal{sup ®}-VCD in one and MC in the other intervention. Patients were clinically and sonographically examined and were given questionnaires 1 day after intervention [groin- and back-pain during bedrest (100-point visual analog scale; 0: no pain); comfortability of bedrest (10-point Likert scale, 1: comfortable), satisfaction with closure (10-point Likert scale, 1: very satisfied)].more » Results were analyzed in a cross-over design.Results48 patients (29 male, median age 62.5 (32–88) years) were included. An ExoSeal{sup ®}-VCD was used first in 25 cases. As four of these subsequently refused MC as second intervention, data from 44 patients could be analyzed. All closures were technically successful (successful device deployment) without major complications. Groin- and back-pain after VCD-use/MC was 0 (0–15) vs. 10 (0–80) and 0 (0–75) vs. 25 (0–90), respectively (p < 0.0001). Bedrest after VCD-use was more comfortable than after MC [1 (range 1–7) vs. 6 (2–10); p < 0.0001]. Satisfaction with the closure procedure and with the intervention in general was higher after VCD-use compared to MC [1 (1–3) vs. 5 (2–10) and 1 (1–2) vs. 2 (1–4), respectively; p < 0.0001].ConclusionIntra-individual comparison showed pain levels and discomfort to be significantly lower after ExoSeal{sup ®} use compared to MC. VCD closure was associated with higher satisfaction both with the closure itself and with the intervention in general.« less

Outcomes of mechanical stapling for postlaryngectomy open pharyngotomy closure.

PubMed

Paddle, Paul; Husain, Inna; McHugh, Lauren; Franco, Ramon

2017-03-01

A total laryngectomy (TL) is performed as a primary or salvage therapy for laryngeal carcinoma. Pharyngotomy closure after TL is typically performed using manual sutures. Automatic stapling devices are routinely used in thoracoabdominal surgery, but have not been widely accepted for use in pharyngotomy closure. Previously described closed stapling techniques of pharyngeal closure do not allow direct evaluation of surgical margins and are limited to endolaryngeal disease. We describe an open technique for pharyngotomy closure using a mechanical stapling device. Retrospective review. A review was conducted of 16 total laryngectomies performed from May 2008 to August 2015 utilizing an Ethicon Endopath ETS Compact-Flex 45 stapler. Sixteen patients (15 male, one female), mean age 69 years, received open TL (14 salvage, two primary) with endostapler pharyngeal closure and primary tracheoesophageal puncture (TEP). Surgical time averaged 218 minutes. Median time to swallowing was 4 days (range, 2-240 days) and mean hospital stay 6 days (range, 3-10 days). Fistula incidence was 31% (5/16) overall and 36% (5/14) in the postradiation patients. Mechanical stapling is a simple method for postlaryngectomy open pharyngotomy closure. This technique allows evaluation of margins, easy primary TEP, and the opportunity for early swallowing and shorter hospital stays. In addition, it can be performed for closure of salvage laryngectomies with rates of fistula formation similar to that found in the literature using suture closure techniques. Future studies are necessary to compare oncological results and surgical complications between the open and closed stapling techniques and to traditional suture closure. 4 Laryngoscope, 127:605-610, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

Efficacy and safety of percutaneous left atrial appendage closure to prevent thromboembolic events in atrial fibrillation patients with high stroke and bleeding risk.

PubMed

Seeger, Julia; Bothner, Carlo; Dahme, Tillman; Gonska, Birgid; Scharnbeck, Dominik; Markovic, Sinisa; Rottbauer, Wolfgang; Wöhrle, Jochen

2016-03-01

The randomized PROTECT AF trial demonstrated non-inferiority of left atrial appendage (LAA) closure to oral anticoagulation with warfarin. Current guidelines give a class IIb recommendation for LAA closure. We evaluated the efficacy and safety of LAA closure in a consecutive series of non-valvular atrial fibrillation patients with contraindications to long-term oral anticoagulation or at high bleeding risk. 101 consecutive non-valvular atrial fibrillation patients (age 74.7 ± 7.5 years) at high risk for stroke (CHA2DS2-VASc Score 4.4 ± 1.6) and high bleeding risk (HAS-BLED Score 4.2 ± 1.3) received LAA closure with either the Watchman closure device (n = 38) or the Amplatzer cardiac plug (n = 63). Dual antiplatelet therapy with aspirin and clopidogrel was recommended for 3-6 months after device implantation, followed by long-term antiplatelet therapy with aspirin. No anticoagulation was given after device implantation. Mean follow-up was 400 days. One patient (1 %) experienced a transient ischemic attack, and two patients (2 %) suffered from ischemic stroke. While on recommended antiplatelet therapy, bleeding occurred in 12/101 patients (12 %). Bleeding was significantly reduced with 3 compared with 6 months dual antiplatelet therapy (3.0 vs. 16.2 %, p < 0.05) while ischemic or thrombotic events were similar. Left atrial appendage closure in patients with non-valvular atrial fibrillation and high risk for stroke and bleeding events effectively prevented stroke and reduced cerebral ischemic events compared to expected stroke rate according to CHA2DS2-VASc Score. Dual antiplatelet therapy for 3 months reduced the rate of bleeding events compared to 6 months therapy with no increase of thrombotic events.

Recruitment of mesenchymal stem cells and macrophages by dual release of stromal cell-derived factor-1 and a macrophage recruitment agent enhances wound closure.

PubMed

Kim, Yang-Hee; Tabata, Yasuhiko

2016-04-01

In this study, the wound closure of mouse skin defects was examined in terms of recruitment of mesenchymal stem cells (MSC) and macrophages. For the cells recruitment, stromal derived factor-1 (SDF-1) of a MSC recruitment agent and sphingosine-1 phosphate agonist (SEW2871) of a macrophages recruitment agent were incorporated into gelatin hydrogels, and then released in a controlled fashion. When applied to a skin wound defect of mice, gelatin hydrogels incorporating mixed 500 ng SDF-1 and 0.4, 0.8, or 1.6 mg SEW2871-micelles recruited a higher number of both MSC and macrophages than those incorporating SDF-1 or phosphate buffered saline. However, the number of M1 phenotype macrophages for the hydrogel incorporating mixed SDF-1 and SEW2871-micelles recruited was remarkably low to a significant extent compared with that for those hydrogel incorporating 0.4, 0.8, or 1.6 mg SEW2871-micelles. On the other hand, the number of M2 macrophages 3 days after the implantation of the hydrogels incorporating SDF-1 and 0.4 mg SEW2871-micelles significantly increased compared with that for other hydrogels. In vivo experiments revealed the hydrogels incorporating SDF-1 and 0.4 mg SEW2871-micelles promoted the wound closure of skin defect to a significant stronger extent than those incorporating SEW2871-micelles, SDF-1, and a mixture of SDF-1 and higher doses of SEW2871-micelles. It is concluded that the in vivo recruitment of MSC and macrophages to the defects may contribute to the tissue regeneration of skin wound. © 2016 Wiley Periodicals, Inc.

The Temporalis Muscle Flap for Palate Reconstruction: Case Series and Review of the Literature

PubMed Central

Brennan, Tara; Tham, Tristan M.; Costantino, Peter

2017-01-01

Introduction  The temporalis myofascial (TM) is an important reconstructive flap in palate reconstruction. Past studies have shown the temporalis myofascial flap to be safe as well as effective. Free flap reconstruction of palate defects is also a popular method used by contemporary surgeons. We aim to reaffirm the temporalis myofascial flap as a viable alternative to free flaps for palate reconstruction. Objective  We report our results using the temporalis flap for palate reconstruction in one of the largest case series reported. Our literature review is the first to describe complication rates of palate reconstruction using the TM flap. Methods  Retrospective chart review and review of the literature. Results  Fifteen patients underwent palate reconstruction with the TM flap. There were no cases of facial nerve injury. Five (33%) of these patients underwent secondary cranioplasty to address temporal hollowing after the TM flap. Three out of fifteen (20%) had flap related complications. Fourteen (93%) of the palate defects were successfully reconstructed, with the remaining case pending a secondary procedure to close the defect. Ultimately, all of the flaps (100%) survived. Conclusion  The TM flap is a viable method of palate defect closure with a high defect closure rate and flap survival rate. TM flaps are versatile in repairing palate defects of all sizes, in all regions of the palate. Cosmetic deformity created from TM flap harvest may be addressed using cranioplasty implant placement, either primarily or during a second stage procedure. PMID:28680495

[Robot-assisted atrial septal defect closure in adults: first experience in Russia].

PubMed

Arkhipov, A N; Bogachev-Prokofiev, A V; Zubritskiy, A V; Khapaev, T S; Gorbatykh, Yu N; Pavlushin, P M; Karaskov, A M

To analyze immediate results of minimally invasive robot-assisted atrial septal defect (ASD) closure in adults. For the period from March 2012 to November 2016 sixty patients with contraindications to endovascular procedure have undergone robot-assisted atrial septal defect closure at Meshalkin Siberian Federal Biomedical Research Center. Mean age was 34.5±11.3 years, body mass index - 24.6±4.0 kg/m 2 . 48 (80%) patients had NYHA class II before surgery. In 37 (61.7%) patients isolated ASD with deficiency or absence of one edge was diagnosed, isolated ASD with primary septum aneurysm - in 16 (26.7%) cases, 7 (11.6%) patients had reticulate ASD. 5 (8.3%) patients had concomitant tricuspid valve insufficiency required surgical repair (suture annuloplasty). All operations were performed under cardiopulmonary bypass with peripheral cannulation. Right-sided anterolateral mini-thoracotomy was used in the first 43 patients. Following 17 patients underwent completely endoscopic procedure. Depending on the shape, size and anatomical features of the defect we performed suturing (14 patients, 23.3%) or repair with xenopericardial patch (46%, 76.6%). Mean CPB and aortic cross-clamping time was 89.1±28.7 and 24.8±9.5 min, respectively. Postoperative variables: mechanical ventilation 3.3±1.5 hours, ICU-stay - 18.2±3.7 hours, postoperative hospital-stay - 13.4±5.7 days. There were no mortality and any life-threatening intra- and postoperative complications. Cases of conversion to thoraco-/sternotomy and postoperative bleeding followed by redo surgery were also absent. 23 patients were followed-up within 1 year, 6 patients - within 2 years, 3 patients - within 3 years. All patients were in NYHA class I-II with 100% freedom from ASD recanalization and redo surgery. According to echocardiography data there were decreased right heart, pulmonary artery pressure and preserved left ventricular function in early postoperative period and 1 year after surgery. In view of favorable course of postoperative period, no significant specific complications and encouraging immediate results we can talk about endoscopic robot-assisted ASD closure in adults as a safe and effective alternative to surgical treatment.

Percutaneous closure of patent ductus arteriosus in children using amplatzer duct occluder II: relationship between PDA type and risk of device protrusion into the descending aorta.

PubMed

Masri, Samer; El Rassi, Issam; Arabi, Mariam; Tabbakh, Anas; Bitar, Fadi

2015-08-01

To compare the efficacy and safety of Amplatzer Duct Occluder II (ADOII) among the various patent ductus arteriosus (PDA) types, and to assess the association between development of aortic obstruction and the PDA type in terms of measurable parameters as the device angulation and distance of upper end protrusion into the aortic lumen. Retrospective cohort study involving 50 consecutive subjects who underwent ADO II device closure of PDA. The median age and weight at intervention were 13 months (5.5 months to 18 years) and 11 (6-67) kg respectively. The median smallest ductal diameter by angiography was 3.2 (1.9-5.4) mm. Thirty two patients had type A PDA, 5 had type C, 5 had type D, and 8 had type E. Residual shunt was seen in only 1 patient who had a tubular PDA and resolved within 2 months of the procedure. No device embolization or pulmonary side protrusion were noted. There was a 16% aortic protrusion rate. The median distance of protrusion of the upper end of the device into the aortic lumen was 3.1 (0-9) mm and the median angle formed between the aortic end of the device and the PDA take-off was 10.4 (0-80.6) degrees. These latter parameters of aortic obstruction were significantly higher in the non-conical PDA group as compared to the conical PDA. Nevertheless, there was no significant coarctation due to aortic retention disc protrusion. Device closure of PDA using the ADO II is a safe procedure for chosen types of PDA. We demonstrated a novel technique for objective assessment of device protrusion into the descending aorta based on measurable parameters. ADOII device closure of non-conical PDAs warrants closer follow ups. © 2015 Wiley Periodicals, Inc.

A Challenging Case of Patent Ductus Arteriosus Device Closure in an Adult with Unconventional Views and Catheters

PubMed Central

Garg, Naveen; Raja, Deep Chandh; Khanna, Roopali; Kumar, Sudeep

2018-01-01

Abnormally oriented patent ductus arteriosus is expected in adults, which can lead to difficulties while attempting a device closure. Alternate angiographic views like the “right anterior oblique view,” “retrograde approach” and in rare cases, as elicited in the following case scenario, special catheters like the “Tiger® catheter” can aid in crossing the lesion and completion of the procedure successfully. PMID:29876027

A high-throughput three-dimensional cell migration assay for toxicity screening with mobile device-based macroscopic image analysis

PubMed Central

Timm, David M.; Chen, Jianbo; Sing, David; Gage, Jacob A.; Haisler, William L.; Neeley, Shane K.; Raphael, Robert M.; Dehghani, Mehdi; Rosenblatt, Kevin P.; Killian, T. C.; Tseng, Hubert; Souza, Glauco R.

2013-01-01

There is a growing demand for in vitro assays for toxicity screening in three-dimensional (3D) environments. In this study, 3D cell culture using magnetic levitation was used to create an assay in which cells were patterned into 3D rings that close over time. The rate of closure was determined from time-lapse images taken with a mobile device and related to drug concentration. Rings of human embryonic kidney cells (HEK293) and tracheal smooth muscle cells (SMCs) were tested with ibuprofen and sodium dodecyl sulfate (SDS). Ring closure correlated with the viability and migration of cells in two dimensions (2D). Images taken using a mobile device were similar in analysis to images taken with a microscope. Ring closure may serve as a promising label-free and quantitative assay for high-throughput in vivo toxicity in 3D cultures. PMID:24141454

Treatment Strategies in 135 Consecutive Patients with Enterocutaneous Fistulas

PubMed Central

Visschers, Ruben G. J.; Damink, Steven W. M. Olde; Winkens, Bjorn; Soeters, Peter B.

2008-01-01

Background Enterocutaneous fistulas (ECF) pose a major challenge to every gastrointestinal (GI) surgeon. Based on earlier studies, a standardized treatment guideline was implemented. The focus of the present study was to assess that guideline and determine prognostic factors for outcome of patients with ECF, and to define a more detailed therapeutic approach including the convalescence time before restorative surgery. Methods All patients with ECF treated between 1990 and 2005 were included. Management consisted of controlling Sepsis, Optimization of nutritional state, Wound care, assessment of fistula Anatomy, Timing of surgery, and Surgical strategy (the SOWATS guideline). Prognostic factors were assessed by way of multiple logistic regression analysis. Results A total of 135 patients were treated at our unit. Overall closure was achieved in 118 patients (87.4%). Restorative operations for fistula closure were performed after a median of 53 days (range: 4–270 days). Restorative operations were successful in 97/107 patients (90.7%). Thirteen patients (9.6%) died. An abdominal wall defect was the most predominant negative prognostic factor for spontaneous closure (odds ratio [OR] = 0.195, confidence interval [CI] 0.052–0.726, p = 0.015). A strong relation was found between preoperative albumin level and surgical closure (p < 0.001) and mortality (p < 0.001). Conclusions Application of the SOWATS guideline allowed a favorable outcome after a short convalescence period. Abdominal wall defects and preoperative hypoalbuminemia are important prognostic variables. PMID:18175171

Treatment strategies in 135 consecutive patients with enterocutaneous fistulas.

PubMed

Visschers, Ruben G J; Olde Damink, Steven W M; Winkens, Bjorn; Soeters, Peter B; van Gemert, Wim G

2008-03-01

Enterocutaneous fistulas (ECF) pose a major challenge to every gastrointestinal (GI) surgeon. Based on earlier studies, a standardized treatment guideline was implemented. The focus of the present study was to assess that guideline and determine prognostic factors for outcome of patients with ECF, and to define a more detailed therapeutic approach including the convalescence time before restorative surgery. All patients with ECF treated between 1990 and 2005 were included. Management consisted of controlling Sepsis, Optimization of nutritional state, Wound care, assessment of fistula Anatomy, Timing of surgery, and Surgical strategy (the SOWATS guideline). Prognostic factors were assessed by way of multiple logistic regression analysis. A total of 135 patients were treated at our unit. Overall closure was achieved in 118 patients (87.4%). Restorative operations for fistula closure were performed after a median of 53 days (range: 4-270 days). Restorative operations were successful in 97/107 patients (90.7%). Thirteen patients (9.6%) died. An abdominal wall defect was the most predominant negative prognostic factor for spontaneous closure (odds ratio [OR]=0.195, confidence interval [CI] 0.052-0.726, p=0.015). A strong relation was found between preoperative albumin level and surgical closure (p<0.001) and mortality (p<0.001). Application of the SOWATS guideline allowed a favorable outcome after a short convalescence period. Abdominal wall defects and preoperative hypoalbuminemia are important prognostic variables.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chan, Gabriel, E-mail: dr.changabriel@gmail.com; Quek, Lawrence Hwee Han, E-mail: lawrence-quek@ttsh.com.sg; Tan, Glenn Leong Wei, E-mail: glenn-tan@ttsh.com.sg

BackgroundInsertion of a carotid chimney graft during thoracic endovascular aortic repair (Ch-TEVAR) is a recognized technique to extend the proximal landing zone into the aortic arch in the treatment of thoracic aortic disease. Conventional technique requires surgical exposure of the carotid artery for insertion of the carotid chimney graft.MethodologyWe describe our experience in the use of a suture-mediated closure device in percutaneous Ch-TEVAR in four patients.ResultsSuccessful hemostasis was achieved in all four patients. No complications related to the carotid puncture were recorded.ConclusionWe conclude that using suture-mediated closure device for carotid closure appears feasible and deserves further studies as a potentialmore » alternative to conventional surgical approach.« less

Loop-anchor purse-string closure of gastrotomy in NOTES(R) procedures: survival studies in a porcine model.

PubMed

Romanelli, John R; Desilets, David J; Chapman, Christopher N; Surti, Vihar C; Lovewell, Carolanne; Earle, David B

2010-12-01

Transgastric NOTES(®) procedures remain without a simple method to close the gastrotomy. In four survival swine studies, we have tested a novel gastric closure device: the loop-anchor purse-string (LAPS) closure system. In four anesthetized pigs, an endoscopic gastrotomy was performed. Four loop anchors were arrayed in a 2-cm square pattern around the gastrotomy. The endoscope was passed into the abdominal cavity, and the gastrotomy was cinched closed. Procedure times ranged from 50-180 minutes. Three pigs survived 14 days. One animal was sacrificed early due to signs of sepsis. Another animal developed fevers and was treated with antibiotics. At necropsy, there were no abscesses, including in the septic animal. Histologic examination revealed evidence of healing in all animals. The LAPS system holds promise with early success in an animal model. Future human studies are needed to determine viability as a human visceral closure device.

Imperforate anus repair - series (image)

MedlinePlus

... a high type imperforate anus defect usually involves creation of a temporary opening of the large intestine ( ... includes a fistula) involves closure of the fistula, creation of an anal opening, and repositioning the rectal ...

Immediate and mid-term clinical course after percutaneous closure of paravalvular leakage.

PubMed

Sánchez-Recalde, Angel; Moreno, Raúl; Galeote, Guillermo; Jimenez-Valero, Santiago; Calvo, Luis; Sevillano, Joel Hernández; Arroyo-Ucar, Eduardo; López, Teresa; Mesa, José M; López-Sendón, José L

2014-08-01

Percutaneous closure of paravalvular leakage is an alternative to surgery in high-risk patients, but its use has been limited by a lack of specific devices. More appropriate devices-like the Amplatzer Vascular Plug III-have recently been developed, but information about their efficacy and safety is still scarce. The objective of the present study was to assess the mid-term results of paravalvular leakage closure with this device. We analyzed the clinical and echocardiographic course both in-hospital and mid-term (13 [9] months) in a series of 20 consecutive patients (age, 68 years; logistic EuroSCORE, 29) with paravalvular leakage and attempted percutaneous closure. Closure was attempted for 23 leaks (17 mitral and 6 aortic) during 22 procedures in 20 patients. Implantation was successful in 87% of the leaks and the procedure was successful in 83%-with success being defined as a reduction in regurgitation of ≥ 1 degree. Survival at 1 year was 64.7% and survival free of the composite event of death/surgery was 58.8%. The degree of residual regurgitation was not associated with mortality but was associated with functional status. Survivors showed significant improvement in functional class. Percutaneous closure of leakage with the Amplatzer Vascular Plug III is safe and efficient in the mid-term. However, mortality among high-risk patients is high independently of the degree of residual regurgitation, indicating that these procedures are performed when heart disease has reached an advanced stage. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

[Two stage surgical treatment of large ventricular septal defects (author's transl)].

PubMed

Hoffmeister, H E; Seybold-Epting, W; Stunkat, R

1976-12-01

Since March 1971, 51 infants were subjected to pulmonary artery banding (PAB) for a large ventricular septal defect (VSD) with pulmonary hypertension. 41 infants (80%) were under six months of age. Additional defects were present in 41%. Twelve babies died (24%). The lowest mortality was achieved in isolated VSD (6,7%). 28 patients subsequently underwent VSD closure and pulmonary artery debanding. Catheterization data revealed normal or slightly elevated pressures and normal vascular resistance in the pulmonary circuit in 22 children. The operative mortality rate was 10,7%.

The Use of Unilateral Pericranial Flaps for the Closure of Difficult Medial Orbital and Upper Lateral Nasal Defects.

PubMed

Newman, Jason; Costantino, Peter; Moche, Jason

2003-11-01

We present 3 cases in which a unilateral pericranial flap was used to repair defects in the medial orbital and upper lateral nasal areas. All three patients had undergone previous excision of malignant tumors from the upper septum and ethmoid areas. Postoperatively, they all received radiation and then developed wound breakdown with fistula formation, particularly in the area of the incisional site. All 3 patients had undergone previous unsuccessful repair of the fistula. Closure of such fistulas requires well-vascularized nonradiated tissue, which can be provided by a unilateral pericranial flap. This flap is flexible, thin, and well suited to the sinonasal area. Use of this flap avoids the need for a paramedian forehead or other musculocutaneous flap. Cosmetic results were excellent, and there have been no flap breakdowns or complications to date.

Right atrial isolation associated with atrial septal closure in patients with atrial septal defect and chronic atrial fibrillation.

PubMed

Minzioni, G; Graffigna, A; Pagani, F; Vigano, M

1993-12-01

To restore sinus rhythm in the remaining heart chambers of six adult patients with atrial septal defect and chronic or paroxysmal atrial fibrillation, electrical, right atrial isolation associated with surgical correction of the defect was performed. All but one patient was free from atrial fibrillation without medication 2-25 months after operation. The isolated right atrial appendages showed intrinsic rhythmical activity in five patients and no electrical activity in one. Right atrial isolation is a safe and effective procedure that abolishes atrial fibrillation in patients with arrhythmia after surgical correction of atrial septal defect.

Composite three-layer closure of oral antral communication with 10 months follow-up-a case study.

PubMed

Weinstock, Robert J; Nikoyan, Levon; Dym, Harry

2014-02-01

We propose a 3-layer composite closure technique for an oral antral communication (OAC) while avoiding secondary donor site morbidity. A patient had developed a 1-cm OAC after extraction of right maxillary first molar. The patient subsequently developed acute maxillary sinusitis. The patient was taken to the operating room, and a Caldwell-Luc procedure was performed. The bony window from the Caldwell-Luc was "press fit" over the bony OAC defect. Soft tissue closure was then achieved with a buccal fat pad flap and a buccal mucosal advancement flap. The patient was examined on postoperative day 5 and 1, 2, 3, 6, and 10 months postoperatively. The acute sinusitis had resolved. The soft tissue closure was successful. The bone graft remained intact, prevented sinus pneumatization, and restored continuity to the floor of the maxillary sinus. The presented technique for 3-layer closure of OACs allows for the stability of a double-layer closure of OAC with the added benefit of bone grafting from single operative site, achieving stable oral antral closure, bone grafting, and the avoidance of secondary donor site morbidity. Copyright © 2014 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Stratifying photo plots into volume classes...by crown closure comparator

Treesearch

Robert C. Aldrich

1967-01-01

As an aid to aerial photo interpretation, a Crown Closure Comparator has been developed. Printed as a positive film transparency, this device shows tree crowns as open dots on a black background. The Comparator is used to stratify I-acre plots into broad volume classes on single aerial photos using 4 crown-diameter and 9 crown-closure classes. It can also be used for...

CLOSURE OF LARYNGECTOMY DEFECTS IN THE AGE OF CHEMORADIATION THERAPY

PubMed Central

Hanasono, Matthew M.; Lin, Derrick; Wax, Mark K.

2014-01-01

The use of chemoradiation therapy in laryngeal cancer has resulted in significant reconstructive challenges. Although reconstruction of salvage laryngectomy defects remains controversial, current literature supports aggressive management of these defects with vascularized tissue, even when there is sufficient pharyngeal tissue present for primary closure. Significant advancement in reconstructive techniques has permitted improved outcomes in patients with advanced disease who require total laryngopharyngectomy or total laryngoglossectomy. Use of enteric and fasciocutaneous flaps result in good patient outcomes. Finally, wound complication rates after salvage surgery approach 60% depending on comorbid conditions such as cardiac insufficiency, hypothyroidism, or extent of previous treatment. Neck dehiscence, great vessel exposure, fistula formation, or cervical skin necrosis results in complex wounds that can often be treated initially with negative pressure dressings followed by definitive reconstruction. The timing of repair and approach to the vessel-depleted neck also present challenges in this patient population. Currently, there is significant institutional bias in the management of the patient with postchemoradiation salvage laryngectomy. Future prospective multi-institutional studies are certainly needed to more clearly define optimal treatment of these difficult patients. PMID:21416549

Injectible candidate sealants for fetal membrane repair: Bonding and toxicity in vitro

PubMed Central

Bilic, Grozdana; Brubaker, Carrie; Messersmith, Phillip B.; Mallik, Ajit S.; Quinn, Thomas M.; Haller, Claudia; Done, Elisa; Gucciardo, Leonardo; Zeisberger, Steffen M.; Zimmermann, Roland; Deprest, Jan; Zisch, Andreas H.

2010-01-01

Objective This study was undertaken to test injectible surgical sealants that are biocompatible with fetal membranes, eventually for closure of iatrogenic membrane defects. Study Design Dermabond, Histoacryl, Tissucol fibrin glue, and three types of in situ forming poly(ethylene glycol)-based polymer hydrogels were tested for acute toxicity upon direct contact with fetal membranes for 24h. For determination of elution toxicity, extracts of sealants were incubated on amnion cell cultures for 72h. Bonding and toxicity was assessed through morphological and/or biochemical analysis. Results Extracts of all adhesives were non-toxic for cultured cells. However, only Tissucol and one type of poly(ethylene glycol)-based hydrogel, mussel-mimetic tissue adhesive, showed efficient, non-disruptive, non-toxic bonding to fetal membranes. Mussel-mimetic tissue adhesive applied over membrane defects created with a 3.5 mm trocar accomplished leak-proof closure that withstood membrane stretch in an in vitro model. Conclusion A synthetic hydrogel-type tissue adhesive emerged as potential sealing modality for iatrogenic membrane defects that merits further evaluation in vivo. PMID:20096254

[Migraine and cadiac shunts - is there a link?].

PubMed

Riederer, Franz

2012-10-17

Recently an association between migraine and cardiac shunts (e.g. through a patent foramen ovale, PFO) has been described. There is evidence from mostly retrospective case series that PFO closure can significantly improve migraine. On the other hand an increase in attack frequency or de novo migraine after percutaneous closure of an atrial septal defect has been described. Animal experiments showed that microemboli in the cerebral circulation can trigger a cortical spreading depression, which is believed the pathophysiological substrate of migraine aura. A randomized controlled trial that investigated PFO closure for treatment resistant migraine with aura was negative. It is currently discussed whether certain subgroups, who have a high risk for paradoxical embolism, might improve after PFO closer.

Comparison of effectiveness and cost of patent ductus arteriosus device occlusion versus surgical ligation of patent ductus arteriosus.

PubMed

Zulqarnain, Arif; Younas, Muhammad; Waqar, Tariq; Beg, Ahsan; Asma, Touseef; Baig, Mirza Ahmad Raza

2016-01-01

Comparison of effectiveness and cost of transcatheter occlusion of patent ductus arteriosus (PDA) with surgical ligation of PDA. This retrospective comparative study was conducted in the pediatric cardiology department of Ch. Pervaiz Elahi Institute of Cardiology Multan, Pakistan. Data of 250 patients who underwent patent ductus arteriosus (PDA) closure either surgical or trans-catheter closure using SHSMA Occluder having weight >5 kg from April 2012 to October 2015 were included in this study. SPSS version 20 was used for data analysis. Quantitative variables were compared using independent sample t-test. Chi-square test and fishers exact was used for qualitative variables. P-value <0.05 was considered statistically significant. There were one hundred and twenty (120) patients who underwent transcatheter occlusion of PDA using SHSMA occluder (PDA Device Group) and one hundred and thirty (130) patients who underwent surgical ligation of PDA (Surgical Group). Incidence of residual shunting was two (1.5%) in surgical group and 0 (0.0%) in PDA Device group for one month follow up period. There were 4 (3.1%) major complications in surgical group. The rate of blood transfusions were high in surgical group (p-value 0.04). Hospital stay time was significantly less in PDA Device group (P-value <0.001). Total procedural cost was 110695+1054 Pakistani rupees in PDA Device group and 92414+3512 in surgical group (p-value <0.001). The cost of PDA device closure was 16.52% higher than the surgical ligation of PDA. There was no operative mortality. The transcatheter closure of PDA is an effective and less invasive method as compared to the surgical ligation. There is a lower rate of complications and the cost is not much high as compared to surgical PDA ligation.

Electron-beam-induced information storage in hydrogenated amorphous silicon devices

DOEpatents

Yacobi, B.G.

1985-03-18

A method for recording and storing information in a hydrogenated amorphous silicon device, comprising: depositing hydrogenated amorphous silicon on a substrate to form a charge collection device; and generating defects in the hydrogenated amorphous silicon device, wherein the defects act as recombination centers that reduce the lifetime of carriers, thereby reducing charge collection efficiency and thus in the charge collection mode of scanning probe instruments, regions of the hydrogenated amorphous silicon device that contain the defects appear darker in comparison to regions of the device that do not contain the defects, leading to a contrast formation for pattern recognition and information storage.

Reconstruction with a 180-degree Rotationally Divided Latissimus-dorsi-musculocutaneous Flap after the Removal of Locally Advanced Breast Cancer

PubMed Central

Kirita, Miho; Sakurai, Hiroyuki

2014-01-01

Summary: This study described a technique for reconstruction of a large lateral thoracic region defect after locally advanced breast cancer resection that allows for full coverage of the defect and primary closure of the flap donor site. The authors performed reconstruction using the newly designed 180-degree rotationally-divided latissimus-dorsi-musculocutaneous flap in a 42-year-old woman for coverage of a large skin defect (18 × 15 cm) following extensive tissue resection for locally advanced breast cancer. The latissimus-dorsi-musculocutaneous flap, consisting of two rotated skin islands (18 × 7.5 cm each) that were sutured to form a large skin island, was used for coverage of the defect. The flap was sutured without causing excessive tension in the recipient region and the donor site was closed with simple reefing. No skin grafting was necessary. The flap survived completely, shoulder joint function was intact, and esthetic outcome was satisfactory. Quick wound closure allowed postoperative irradiation to be started 1 month after surgery. The technique offered advantages over the conventional pedicled latissimus-dorsi-musculocutaneous flap, but the flap was unable to be used, when the thoracodorsal artery and vein were damaged during extensive tissue removal. Detailed planning before surgery with breast surgeons would be essential. PMID:25426400

77 FR 55496 - Notice of Temporary Closure of Public Lands in Eastern Lassen County, California, and Western...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-10

... protection and State, local and Federal officials involved with enforcement. This closure is necessary to.... Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay...

Fournier's Gangrene: Current Practices

PubMed Central

Mallikarjuna, M. N.; Vijayakumar, Abhishek; Patil, Vijayraj S.; Shivswamy, B. S.

2012-01-01

Fournier's gangrene is an acute, rapidly progressive, and potentially fatal, infective necrotizing fasciitis affecting the external genitalia, perineal or perianal regions, which commonly affects men, but can also occur in women and children. There has been an increase in number of cases in recent times. Despite advanced management mortality is still high and averages 20–30%. Early diagnosis using Laboratory Risk Indicator for Necrotizing Fasciitis score and stratification of patients into high risk category using Fournier's Gangrene Severity Index score help in early initiation of treatment. Triple antibiotic combined with radical debridement is the mainstay of treatment. There have been many advances in management of Fournier gangrene including use of vaccum assisted closure and hyperbaric oxygen therapy. With introduction of newer devices like Flexi-Seal, fecal diversion can be done, avoiding colostomy. Reconstruction of perineal defects using skin grafts, flaps, and urethral reconstruction using gracilis flaps can reduce the morbidity associated with FG and provide acceptable functional and aesthetic outcomes. PMID:23251819

Aneurysmal coronary cameral fistula

PubMed Central

Jamil, Gohar; Khan, Asad; Malik, Azhar; Qureshi, Anwer

2013-01-01

A 26-year-old asymptomatic man, being medically managed for ventricular septal defect since childhood, presented to the outpatient clinic for a second opinion. Clinically, he was well built with normal vital signs. Cardiac auscultation was significant for a diastolic murmur over the praecordium. An ECG showed non-specific ST changes, and a subsequent transthoracic echocardiography performed revealed diastolic flow from the left ventricular (LV) anteroseptal wall into the LV cavity. A diagnosis of coronary–cameral fistula was confirmed by a multidetector CT which showed a 2.5×2 cm aneurysmal left anterior descending artery fistula to the LV. In addition to starting aspirin, transcatheter closure with occlusion device was considered knowing the potential risk of thrombus formation in the aneurysm and subsequent systemic embolisation. The patient however refused any percutaneous or surgical intervention. He remains asymptomatic 1 year after returning to his home country. PMID:23737570

Cost effectiveness of left atrial appendage closure with the Watchman device for atrial fibrillation patients with absolute contraindications to warfarin

PubMed Central

Reddy, Vivek Y.; Akehurst, Ronald L.; Armstrong, Shannon O.; Amorosi, Stacey L.; Brereton, Nic; Hertz, Deanna S.; Holmes, David R.

2016-01-01

Abstract Aims Atrial fibrillation (AF) patients with contraindications to oral anticoagulation have had few options for stroke prevention. Recently, a novel oral anticoagulant, apixaban, and percutaneous left atrial appendage closure (LAAC) have emerged as safe and effective therapies for stroke risk reduction in these patients. This analysis assessed the cost effectiveness of LAAC with the Watchman device relative to apixaban and aspirin therapy in patients with non-valvular AF and contraindications to warfarin therapy. Methods and results A cost-effectiveness model was constructed using data from three studies on stroke prevention in patients with contraindications: the ASAP study evaluating the Watchman device, the ACTIVE A trial of aspirin and clopidogrel, and the AVERROES trial evaluating apixaban. The cost-effectiveness analysis was conducted from a German healthcare payer perspective over a 20-year time horizon. Left atrial appendage closure yielded more quality-adjusted life years (QALYs) than aspirin and apixaban by 2 and 4 years, respectively. At 5 years, LAAC was cost effective compared with aspirin with an incremental cost-effectiveness ratio (ICER) of €16 971. Left atrial appendage closure was cost effective compared with apixaban at 7 years with an ICER of €9040. Left atrial appendage closure was cost saving and more effective than aspirin and apixaban at 8 years and remained so throughout the 20-year time horizon. Conclusions This analysis demonstrates that LAAC with the Watchman device is a cost-effective and cost-saving solution for stroke risk reduction in patients with non-valvular AF who are at risk for stroke but have contraindications to warfarin. PMID:26838691

MAGNETIC END CLOSURES FOR PLASMA CONFINING AND HEATING DEVICES

DOEpatents

Post, R.F.

1963-08-20

More effective magnetic closure field regions for various open-ended containment magnetic fields used in fusion reactor devices are provided by several spaced, coaxially-aligned solenoids utilized to produce a series of nodal field regions of uniform or, preferably, of incrementally increasing intensity separated by lower intensity regions outwardly from the ends of said containment zone. Plasma sources may also be provided to inject plasma into said lower intensity areas to increase plasma density therein. Plasma may then be transported, by plasma diffusion mechanisms provided by the nodal fields, into the containment field. With correlated plasma densities and nodal field spacings approximating the mean free partl cle collision path length in the zones between the nodal fields, optimum closure effectiveness is obtained. (AEC)

Influence of deep defects on device performance of thin-film polycrystalline silicon solar cells

NASA Astrophysics Data System (ADS)

Fehr, M.; Simon, P.; Sontheimer, T.; Leendertz, C.; Gorka, B.; Schnegg, A.; Rech, B.; Lips, K.

2012-09-01

Employing quantitative electron-paramagnetic resonance analysis and numerical simulations, we investigate the performance of thin-film polycrystalline silicon solar cells as a function of defect density. We find that the open-circuit voltage is correlated to the density of defects, which we assign to coordination defects at grain boundaries and in dislocation cores. Numerical device simulations confirm the observed correlation and indicate that the device performance is limited by deep defects in the absorber bulk. Analyzing the defect density as a function of grain size indicates a high concentration of intra-grain defects. For large grains (>2 μm), we find that intra-grain defects dominate over grain boundary defects and limit the solar cell performance.

Transient left ventricular systolic dysfunction following surgical closure of large patent ductus arteriosus among children and adolescents operated at the cardiac centre, Ethiopia

PubMed Central

2013-01-01

Background Patent ductus arteriosus (PDA) is one of the commonest congenital heart diseases that require closure within the first few months after birth. The residential area of patients affects the size of the PDA: living in highlands, like most places in Ethiopia, is a risk for having larger sized PDA. Closure of these congenital heart defects is usually performed at an early age in places where capable centers are available. In Ethiopia, closure of these defects is done on mission basis often at an older age. Recently, limited reports came about the occurrence of postoperative left ventricular systolic dysfunction (POLVD) following closure of PDA though full explanation is still lacking. Objective To determine the rate of and time to improvement of POLVD and the factors associated with it in children and adolescents who underwent surgical closure of PDA. Method All children and adolescents who underwent surgical closure of PDA at the Cardiac Center, Ethiopia (CCE) had postoperative follow up with echocardiography. Serial left ventricular ejection fraction (LVEF) and fiber shortening (FS) values were recorded for all of them. SPSS 20 was used to analyze the data. Results A total of 36 children and adolescents who underwent surgical closure of PDA from January 2009 to December 2012 and who fulfilled the inclusion criteria were studied. Their mean age at intervention was 8.52 years (SD = 5.23 years), 77.80% were females. The mean duct size as determined by either echocardiography or intra-operative by the surgeon was 10.31 mm (SD = 3.20 mm). They were followed for a mean duration of 24.80 months (SD = 12.36 months) following surgical closure of PDA. The mean LVEF and FS decreased from 65.06% and 35.28% preoperatively to 54.83% and 28.40% post-operatively respectively. Fifteen (42.86%) of the patients had a post-operative LVEF of less than 55%. The mean time to normalization of systolic function was 5.11 weeks (SD = 3.30 weeks). Having an associated cardiac lesion was an independent predictor of POLVD. Conclusions We conclude that there is a high rate of POLVD following surgical closure of large PDA in highlanders. We recommend a serial and systematic follow up of these children postoperatively. Those with a significant cardiac dysfunction may need cardiac medications like Angiotensin Converting Enzyme Inhibitors (ACEI). PMID:23721219

Post-Closure Inspection Report for the Tonopah Test Range, Nevada: For Calendar Year 2017, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Alvarado, Juan; Matthews, Patrick

This report provides the results of the annual post-closure inspections conducted at the closed corrective action units (CAUs) located on the Tonopah Test Range (TTR) and the Nevada Test and Training Range (NTTR). This report covers calendar year 2017 and includes visual inspection and repair activities completed at the following CAUs: CAU 400: Bomblet Pit and Five Points Landfill (TTR) CAU 407: Roller Coaster RadSafe Area (TTR) CAU 424: Area 3 Landfill Complexes (TTR) CAU 453: Area 9 UXO Landfill (TTR) CAU 487: Thunderwell Site (TTR) Visual inspections were conducted according to the post-closure plans in the approved closure reportsmore » and subsequent correspondence with the Nevada Division of Environmental Protection. The annual post-closure inspections were conducted on May 23, 2017. No maintenance or repair issues were noted at CAU 400 and CAU 487. Maintenance items and subsequent repairs include the following: CAU 407: A large animal burrow was observed in the southeast corner of the cover during the inspection. Two additional animal burrows were discovered during repair actions. All cover defects were repaired on January 9, 2018. CAU 424: CAS 03-08-002-A304 (Landfill Cell A3-4): A new monument was installed and the subsidence area was repaired on January 9, 2018. CAU 424: CAS 03-08-002-A308 (Landfill Cell A3-8): Lava rock, used to mark the two eastern monument locations, was noted as missing during the inspection. The lava rock was replaced on January 9, 2018. CAU 453: Five large animal burrows, located near the east–central portion of cover, was noted during the inspection. Eight additional animal burrows were discovered during repair actions. All cover defects were repaired on January 9, 2018.« less

BMP9 and BMP10 are necessary for proper closure of the ductus arteriosus

PubMed Central

Levet, Sandrine; Ouarné, Marie; Ciais, Delphine; Coutton, Charles; Subileau, Mariela; Mallet, Christine; Ricard, Nicolas; Bidart, Marie; Debillon, Thierry; Faravelli, Francesca; Rooryck, Caroline; Feige, Jean-Jacques; Tillet, Emmanuelle; Bailly, Sabine

2015-01-01

The transition to pulmonary respiration after birth requires rapid alterations in the structure of the mammalian cardiovascular system. One dramatic change that occurs is the closure of the ductus arteriosus (DA), an arterial connection in the fetus that directs blood flow away from the pulmonary circulation. Two members of the TGFβ family, bone morphogenetic protein 9 (BMP9) and BMP10, have been recently involved in postnatal angiogenesis, both being necessary for remodeling of newly formed microvascular beds. The aim of the present work was to study whether BMP9 and BMP10 could be involved in closure of the DA. We found that Bmp9 knockout in mice led to an imperfect closure of the DA. Further, addition of a neutralizing anti-BMP10 antibody at postnatal day 1 (P1) and P3 in these pups exacerbated the remodeling defect and led to a reopening of the DA at P4. Transmission electron microscopy images and immunofluorescence stainings suggested that this effect could be due to a defect in intimal cell differentiation from endothelial to mesenchymal cells, associated with a lack of extracellular matrix deposition within the center of the DA. This result was supported by the identification of the regulation by BMP9 and BMP10 of several genes known to be involved in this process. The involvement of these BMPs was further supported by human genomic data because we could define a critical region in chromosome 2 encoding eight genes including BMP10 that correlated with the presence of a patent DA. Together, these data establish roles for BMP9 and BMP10 in DA closure. PMID:26056270

Device for testing closure disks at high rates of change of pressure

DOEpatents

Merten, Jr., Charles W.

1993-11-09

A device for testing the burst pressure of closure disks which provides high pressure to both sides of a disk and rapidly releases pressure from one side thereof causing a high rate of change of pressure. A hollow notched plug allows the rapid release of pressure upon rupturing. A means is also disclosed for transmitting a tensile load from a piston to a hollow notched plug and for sealing the means for transmitting load within a hole in a piston.

Intracardiac echocardiography: use during transcatheter device closure of a patent ductus arteriosus in a dog.

PubMed

Chetboul, V; Damoiseaux, C; Behr, L; Morlet, A; Moise, N S; Gouni, V; Lavennes, M; Pouchelon, J-L; Laborde, F; Borenstein, N

2017-06-01

Intracardiac echocardiography (ICE) is used in humans for percutaneous interventional procedures, such as transcatheter device closures. Intracardiac echocardiography provides high-resolution imaging of cardiac structures with two-dimensional, M-mode, Doppler, and also three-dimensional modalities. The present report describes application of ICE during transcatheter occlusion of patent ductus arteriosus using a canine ductal occluder in a dog for which transesophageal echocardiography could not provide an optimal acoustic window. Copyright © 2017 Elsevier B.V. All rights reserved.

49 CFR 173.226 - Materials poisonous by inhalation, Division 6.1, Packing Group I, Hazard Zone A.

Code of Federal Regulations, 2011 CFR

2011-10-01

...; (3) Have screw-type closures that are— (i) Closed and tightened to a torque prescribed by the closure manufacturer, using a properly calibrated device that is capable of measuring torque; (ii) Physically held in...

49 CFR 173.226 - Materials poisonous by inhalation, Division 6.1, Packing Group I, Hazard Zone A.

Code of Federal Regulations, 2012 CFR

2012-10-01

...; (3) Have screw-type closures that are— (i) Closed and tightened to a torque prescribed by the closure manufacturer, using a properly calibrated device that is capable of measuring torque; (ii) Physically held in...

49 CFR 173.226 - Materials poisonous by inhalation, Division 6.1, Packing Group I, Hazard Zone A.

Code of Federal Regulations, 2013 CFR

2013-10-01

...; (3) Have screw-type closures that are— (i) Closed and tightened to a torque prescribed by the closure manufacturer, using a properly calibrated device that is capable of measuring torque; (ii) Physically held in...

49 CFR 173.226 - Materials poisonous by inhalation, Division 6.1, Packing Group I, Hazard Zone A.

Code of Federal Regulations, 2010 CFR

2010-10-01

...; (3) Have screw-type closures that are— (i) Closed and tightened to a torque prescribed by the closure manufacturer, using a properly calibrated device that is capable of measuring torque; (ii) Physically held in...

49 CFR 173.226 - Materials poisonous by inhalation, Division 6.1, Packing Group I, Hazard Zone A.

Code of Federal Regulations, 2014 CFR

2014-10-01

...; (3) Have screw-type closures that are— (i) Closed and tightened to a torque prescribed by the closure manufacturer, using a properly calibrated device that is capable of measuring torque; (ii) Physically held in...

[Evaluation of the external tissue extender (Ete) in secondary wound closure].

PubMed

Zutt, Markus; Beckmann, Iris; Kretschmer, Lutz

2003-09-01

For surgical closure of large skin defects, elaborate reconstructive plastic surgery or other methods such as internal subcutaneous balloon tissue expanders are required in order to avoid tension on the closure margins. Here we point to the benefits and disadvantages of an improved and simple method of secondary wound closure by secondary sutures. We employed a system called External Tissue Extender (ETE), which consists of silicone strings and plastic stoppers pulling the corresponding surgical sites together and evenly distributing the tension. Possible indications in dermatologic surgery and our experiences with this technique are outlined. Implantation and handling of the ETE are very easy and fast. The functional results are good and the cosmetic outcome satisfactory. More invasive surgical procedures can be avoided by using this method. A major disadvantage is the possibility of developing necrosis under the plastic stoppers. According to our experience, the ETE is a useful alternative indicated in certain dermatosurgical situations.

Drosophila heart cell movement to the midline occurs through both cell autonomous migration and dorsal closure.

PubMed

Haack, Timm; Schneider, Matthias; Schwendele, Bernd; Renault, Andrew D

2014-12-15

The Drosophila heart is a linear organ formed by the movement of bilaterally specified progenitor cells to the midline and adherence of contralateral heart cells. This movement occurs through the attachment of heart cells to the overlying ectoderm which is undergoing dorsal closure. Therefore heart cells are thought to move to the midline passively. Through live imaging experiments and analysis of mutants that affect the speed of dorsal closure we show that heart cells in Drosophila are autonomously migratory and part of their movement to the midline is independent of the ectoderm. This means that heart formation in flies is more similar to that in vertebrates than previously thought. We also show that defects in dorsal closure can result in failure of the amnioserosa to properly degenerate, which can physically hinder joining of contralateral heart cells leading to a broken heart phenotype. Copyright © 2014 Elsevier Inc. All rights reserved.

Left ventricular remodeling and change of systolic function after closure of patent ductus arteriosus in adults: device and surgical closure.

PubMed

Jeong, Young-Hoon; Yun, Tae-Jin; Song, Jong-Min; Park, Jung-Jun; Seo, Dong-Man; Koh, Jae-Kon; Lee, Se-Whan; Kim, Mi-Jeong; Kang, Duk-Hyun; Song, Jae-Kwan

2007-09-01

Left ventricular (LV) remodeling and predictors of LV systolic function late after closure of patent ductus arteriosus (PDA) in adults remain to be clearly demonstrated. In 45 patients with PDA, including 28 patients who received successful occlusion using the Amplatzer device (AD group) (AGA, Golden Valley, MN) and 17 patients who received surgical closure (OP group), echocardiography studies were performed before closure and 1 day (AD group) or within 7 days (OP group) after closure, and then were repeated at > or = 6 months (17 +/- 13 months). In both groups, LV ejection fraction (EF) and end-diastolic volume index were significantly decreased immediately after closure, whereas end-systolic volume index did not change. During the long-term follow-up period, end-systolic as well as end-diastolic volume indices decreased significantly in both groups and LV EF recovered compared to the immediate postclosure state. However, LV EF remained low compared to the preclosure state. Five patients (11.1%) including 3 patients in the AD group and 2 patients in the OP group showed persistent late LV systolic dysfunction (EF <50%). In stepwise, multiple logistic regression analysis, preclosure EF was the only independent predictor of late normal postclosure EF (odds ratio, 1.230; 95% CI, 1.054-1.434; P = .008). Receiver operating characteristic curve analysis showed that preclosure EF > or = 62% had a sensitivity of 72% and a specificity of 83% for predicting late normal LV EF after closure. Left ventricular EF remains low late after PDA closure compared with preclosure state in adults. Preclosure LV EF is the best index to predict late postclosure LV EF.

Middle cranial fossa approach for the repair of spontaneous cerebrospinal fluid leaks to the middle ear.

PubMed

Altuna, Xabier; Navarro, Juan José; García, Leire; Ugarte, Ane; Thomas, Izaskun

Spontaneous cerebrospinal fluid (CSF) leaks to the middle ear due to tegmen tympani defects can result in hearing loss or hypoacusis and predispose to meningitis as well as other neurological complications. Surgical repair of the defect can be performed through a middle cranial fossa (MCF) approach or a transmastoid approach. We conducted a retrospective study of the patients in our Department due to a spontaneous CSF leak to the middle ear treated using a MCF approach during a 6-year period (2009-2014). Thirteen patients with spontaneous CSF leak to the middle ear were treated with this approach. The primary and first symptom in all of them was conductive hearing loss. In all cases, the defect or defects were closed in a multilayer manner using muscle, temporalis fascia and cortical bone. Minimum follow-up in this series was 14 months, with successful closure in all but one patient (who required reintervention). We found no intra- or postoperative complications due to the craniotomy, and the audiometry improved and normalised in all cases except for the failed case. The MCF approach with a multilayer closure of the defect is an effective technique for repairing spontaneous CSF leaks to the middle ear and for restoring hearing in these patients. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. All rights reserved.

Percutaneous patent foramen ovale closure: the Paradoxical Cerebral Embolism Prevention Registry.

PubMed

Paiva, Luís; Dinis, Paulo; Providência, Rui; Costa, Marco; Margalho, Susana; Goncalves, Lino

2015-03-01

The natural history and therapeutic interventions for secondary prevention after a cerebrovascular event in patients with patent foramen ovale (PFO) are not yet established. This study aims to assess the safety and efficacy of percutaneous PFO closure in a population of patients with ischemic cerebrovascular disease of unknown etiology. This prospective observational study included patients with a history of cryptogenic transient ischemic attack (TIA) or stroke who underwent percutaneous PFO closure. The effectiveness of the device for the secondary prevention of TIA or stroke was assessed by comparing observed events in the sample with expected events for this clinical setting. The sample included 193 cases of percutaneous PFO closure (age 46.4 ± 13.1 years, 62.2% female) with a mean follow-up of 4.3 ± 2.2 years, corresponding to a total exposure to ischemic events of 542 patient-years. The high-risk characteristics of the PFO were assessed prior to device implantation. There were seven primary endpoint events during follow-up (1.3 per 100 patient-years), corresponding to a relative risk reduction of 68.2% in recurrent TIA or stroke compared to medical therapy alone. The procedure was associated with a low rate of device- or intervention-related complications (1.5%). In this long-term registry, percutaneous PFO closure was shown to be a safe and effective therapy for the secondary prevention of cryptogenic stroke or TIA. Copyright © 2014 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

Events of wound healing/regeneration in the canine supraalveolar periodontal defect model.

PubMed

Dickinson, Douglas P; Coleman, Brandon G; Batrice, Nathan; Lee, Jaebum; Koli, Komal; Pennington, Cathy; Susin, Cristiano; Wikesjö, Ulf M E

2013-05-01

The objective of this research was to elucidate early events in periodontal wound healing/regeneration using histological and immunohistochemical techniques. Routine critical-size, supraalveolar, periodontal defects including a space-providing titanium mesh device were created in 12 dogs. Six animals received additional autologous blood into the defect prior to wound closure. One animal from each group was killed for analysis at 2, 5, 9, 14 days, and at 4 and 8 weeks. Both groups behaved similarly. Periodontal wound healing/regeneration progressed through three temporal phases. Early phase (2-5 days): heterogeneous clot consolidation and cell activation in the periodontal ligament (PDL) and trabecular bone was associated with PDL regeneration and formation of a pre-osteoblast population. Intermediate phase (9-14 days): cell proliferation (shown by PCNA immunostaining)/migration led to osteoid/bone, PDL and cementum formation. Late phase (4-8 weeks): primarily characterized by tissue remodelling/maturation. Fibrous connective tissue from the gingival mucosa entered the wound early, competing with regeneration. By day 14, the wound space was largely filled with regenerative and reparative tissues. Activation of cellular regenerative events in periodontal wound healing/regeneration is rapid; the general framework for tissue formation is broadly outlined within 14 days. Most bone formation apparently originates from endosteally derived pre-osteoblasts; the PDL possibly acting as a supplementary source, with a primary function likely being regulatory/homeostatic. Blood accumulation at the surgical site warrants exploration; supplementation may be beneficial. © 2012 John Wiley & Sons A/S.

Calvarial defect reconstruction.

PubMed

Jimenez, D F; Barone, C M

1994-04-01

The history of skull trepanation is almost as old as that of humanity. For thousands of years it has been performed for the treatment of numerous medical maladies. The Andean Incas, early Asians and South Seas Islanders, are amongst the many people to perform calvarial trepanation. Hippocrates described techniques for the use of the trepan in early Greek times. With the production of a skull opening comes the challenge of developing methods for closing the defect. It is in reality, more challenging to repair the defect than to create it. Man, with his never ending ingenuity, has tried to develop many techniques. We will discuss some of them and present our method of choice for closure of skull defects.

Closure of patent foramen ovale: when and how?

PubMed

Lisignoli, Veronica; Lanzone, Alberto M; Zavalloni, Dennis; Pagnotta, Paolo; Presbitero, Patrizia

2007-10-01

Percutaneous closure of a patent foramen ovale (PFO) was performed in 98 consecutive patients (mean age 52.5 +/- 13 years, 61 women). Indications included recurrent transient ischaemic attack (47%), cryptogenic stroke (34%), peripheral embolism (11%), disabling migraine with aura (4%), professional scuba diving (1 pt) and severe platypnea-orthodeoxia syndrome (1 pt). Each PFO was characterized by transesophageal echocardiography (TEE) according to anatomy, degree of shunt (1-mild, 2-moderate, 3-severe), right atrial anatomical features relevant for PFO closure (such as presence of an Eustachian valve, Chiari network, lipomatosis or absence of septum secundum) with a new classification scheme. According to this classification successful device delivery was obtained in 100% of pts. Major complications included heparin-induced thrombocytopenia in 1 pt and device dislodgment in 1 pt; minor complications were mostly related to the catheter introduction site (2 pts) and mild immediate shunt (2 pts). In conclusion, percutaneous PFO closure based on strict anatomic criteria is a safe procedure with minimal periprocedural complications.

Pan-nitinol occluder and special delivery device for closure of patent ductus arteriosus: a canine-model feasibility study.

PubMed

Jiang, Hai-bin; Bai, Yuan; Zong, Gang-jun; Han, Lin; Li, Wei-ping; Lu, Yang; Qin, Yong-wen; Zhao, Xian-xian

2013-01-01

The aim of this study was to evaluate a new type of occluder for patent ductus arteriosus. Patent ductus arteriosus was established in a canine model by anastomosing a length of autologous jugular vein to the descending aorta and the left pulmonary artery in an end-to-side fashion. Transcatheter closure of each patent ductus arteriosus was performed on 10 dogs, which were then monitored for as long as 6 months with aortography, echocardiography, and histologic evaluation. Transcatheter closure with use of the novel pan-nitinol device was successful in all canine models. Postoperative echocardiography showed that the location and shape of the occluders were normal, without any residual shunting. Further histologic evaluation confirmed that the occluder surface was completely endothelialized 3 months after implantation. Transcatheter patent ductus arteriosus closure with the pan-nitinol occluder can be performed safely and successfully in a canine model and shows good biological compatibility and low mortality rates.

Interventional Closure of a Patent Ductus Arteriosus Using an Amplatz Canine Duct Occluder in an Alpaca Cria.

PubMed

Chapel, E C; Lozier, J; Lakritz, J; Schober, K E

2017-07-01

A 6-month old female alpaca cria presented to The Ohio State University for evaluation of a cardiac murmur. Echocardiography revealed a left-to-right shunting patent ductus arteriosus, a restrictive left-to-right shunting perimembranous ventricular septal defect, and secondary moderate left atrial and ventricular dilation. Aortic root angiography demonstrated a type IIA patent ductus arteriosus (PDA). Interventional closure of the PDA was successfully performed, without complication, using an Amplatz canine duct occluder. This case report describes the materials and methods used for interventional closure of a PDA in an alpaca cria. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Amplatzer angled duct occluder for closure of patent ductus arteriosus larger than the aorta in an infant.

PubMed

Vijayalakshmi, I B; Chitra, N; Rajasri, R; Prabhudeva, A N

2005-01-01

Transcatheter closure of patent ductus arteriosus (PDA) by Amplatzer duct occluder is the treatment of choice. However, closure of very large ducts in infants with low weight is a challenge for the interventionalist because a large device may obstruct the aorta or left pulmonary artery. Difficulty is also encountered in advancing the device around the curve of the right ventricular outflow tract toward the pulmonary artery; this curve is tight, more or less at a right angle in infants, leading to kinking of the sheath, which increases fluoroscopic time. This is the first reported case of a very large PDA (8.7 mm), larger than the aorta (8.2 mm), successfully closed by an Amplatzer angled duct occluder in an infant weighing 5 kg.

Outcomes of gastrointestinal defect closure with an over-the-scope clip system in a multicenter experience: An analysis of a successful suction method

PubMed Central

Kobara, Hideki; Mori, Hirohito; Fujihara, Shintaro; Nishiyama, Noriko; Chiyo, Taiga; Yamada, Takayoshi; Fujiwara, Masao; Okano, Keiichi; Suzuki, Yasuyuki; Murota, Masayuki; Ikeda, Yoshitaka; Oryu, Makoto; AboEllail, Mohamed; Masaki, Tsutomu

2017-01-01

AIM To demonstrate the clinical outcomes of a multicenter experience and to suggest guidelines for choosing a suction method. METHODS This retrospective study at 5 medical centers involved 58 consecutive patients undergoing over-the-scope clips (OTSCs) placement. The overall rates of technical success (TSR), clinical success (CSR), complications, and procedure time were analyzed as major outcomes. Subsequently, 56 patients, excluding two cases that used the Anchor device, were divided into two groups: 14 cases of simple suction (SS-group) and 42 cases using the Twin Grasper (TG-group). Secondary evaluation was performed to clarify the predictors of OTSC success. RESULTS The TSR, CSR, complication rate, and median procedure time were 89.7%, 84.5%, 1.8%, and 8 (range 1-36) min, respectively, demonstrating good outcomes. However, significant differences were observed between the two groups in terms of the mean procedure time (5.9 min vs 14.1 min). The CSR of the SS- and TG-groups among cases with a maximum defect size ≤ 10 mm and immediate or acute refractory bleeding was 100%, which suggests that SS is a better method than TG in terms of time efficacy. The CSR in the SS-group (78.6%), despite the technical success of the SS method (TSR, 100%), tended to decrease due to delayed leakage compared to that in the TG-group (TSR, CSR; 88.1%), indicating that TG may be desirable for leaks and fistulae with defects of the entire layer. CONCLUSION OTSC system is a safe and effective therapeutic option for gastrointestinal defects. Individualized selection of the suction method based on particular clinical conditions may contribute to the improvement of OTSC success. PMID:28321166

46 CFR 151.15-10 - Cargo gauging devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... contains definitions and requirements for types of gauging devices specified in Table 151.05. (a) Open... the cargo and its vapors. Examples of this type are gauge hatch, ullage hole. (b) Restricted. A... closure device in that opening. When not in use, this type gauging device is closed to maintain the...

Craniofacial Prosthetic Reconstruction Using Polymethyl Methacrylate Implant: A Case Report.

PubMed

Simon, Paul; Mohan, Jayashree; Selvaraj, Sunantha; Saravanan, B S; Pari, Parikodaiarasan

2014-12-01

Large cranial defects of complex geometric shapes are challenging to reconstruct. The cranial implants has to be fabricated prior to the cranioplastic surgery. The ideal material for cranial implant has to be inert, light weight, easy to fit and adaptable to the defect, offering the best aesthetic and functional results. Here is a clinical case report of a patient who was operated for osteomyelitis in the parieto-temporal region. The defect was reconstructed with heat cure polymethylmethacrylate (PMMA). Operative closure of the defect was facilitated with ligature titanium wires with minimal prosthesis contouring. The heat cure PMMA cranial implant is a safe, easy and economic alternative with great adaptability to cranial vault defects. The cosmetic results in this patient was excellent. No post-operative complications occurred.

Evaluation of innovative devices to control traffic entering from low-volume access points within a land closure.

DOT National Transportation Integrated Search

2014-04-01

This report describes the methodology and results of analyses performed to identify and evaluate : alternative methods to control traffic entering a lane closure on a two-lane, two-way road from low-volume : access points. Researchers documented the ...

"Ring pledget": a new concept for secure apex closure during transapical aortic valve implantation.

PubMed

Astarci, Parla; Glineur, David; Kefer, Joelle; Renkin, Jean; Vanoverschelde, Jean-Louis; El Khoury, Gebrine

2010-03-01

Transapical aortic valve implantation requires puncture of the left ventricle apex and insertion of a 32-French delivery sheath. A critical step in the procedure consists of secure closure of the ventricular apex. We describe 2 cases of apical rupture of 42 transapical aortic valve implantations. Furthermore, we describe the use of a newly designed single circular Teflon pledget that can help to avoid this complication. This pledget provides a more secure and uniform shrinkage of the entire apex to close the defect left by the delivery sheath.

Thromboembolism after WATCHMANTM in a clopidogrel non-responder: A case for concern?

PubMed

Venkataraman, Ganesh; Bliden, Kevin P; Tantry, Udaya S; Gurbel, Paul A

2017-11-11

Atrial fibrillation (AF) is associated with an increased risk of stroke and thromboembolism (TE). The WATCHMAN TM left atrial appendage (LAA) closure device is indicated to reduce the risk of TE from the LAA in patients with non-valvular AF. Here, we present a case of a patient with device-related thrombus who suffered a TE event two months after WATCHMAN TM LAA closure and two weeks after switching from aspirin plus warfarin to aspirin plus clopidogrel therapy. Laboratory investigation identified the patient to be hypercoagulable and to be a non-responder to clopidogrel therapy. We discuss the potential role of platelet function testing to prevent device-related thrombi. © 2017 Wiley Periodicals, Inc.

Transcatheter closure of patent foramen ovale for secondary prevention of ischemic stroke: Quantitative synthesis of pooled randomized trial data.

PubMed

Hakeem, Abdul; Cilingiroglu, Mehmet; Katramados, Angelos; Boudoulas, Konstantinos Dean; Iliescu, Cezar; Gundogdu, Betul; Marmagkiolis, Konstantinos

2018-01-14

To evaluate the safety and efficacy of percutaneous device closure of patent foramen ovale (PFO) for secondary prevention of ischemic stroke BACKGROUND: Stroke remains the leading cause of serious long-term disability in the United States. The effectiveness of a percutaneous PFO closure in the prevention of recurrent cryptogenic strokes has not been established. We performed a literature search using PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Google Scholar, and Internet-based sources from January 2003 to September 2017. Randomized controlled trails (RCTs) comparing percutaneous PFO closure to medical therapy alone. Five RCTs (CLOSURE I, PC Trial, REDUCE, RESPECT, and CLOSE) with 1,829 patients in the device group and 1,611 patients in the medical group met inclusion criteria. The cumulative incidence of recurrent stroke was 2.02% in the PFO closure arm and 4.4% in the medical therapy group (RR 0.42, 95%CI 0.20, 0.91; P = 0.03). There was no difference in the incidence of death [0.7% vs. 0.9%; RR 0.76 (95% CI 0.35, 1.64), P = 0.49] or adverse events during the follow-up period [24.6% vs. 23.7% (RR 1.03; 95% CI 0.91, 1.16), P = 0.65] between the closure and medical therapy groups. Incidence of atrial fibrillation was significantly higher in closure group compared to medical therapy [4% vs. 0.6% (RR 4.73; 95% CI 2.09, 10.70), P = 0.0002]. The comparative effectiveness of PFO closure (compared to medical therapy) was significantly more pronounced in those younger than 45 years, males, larger shunts and disc design platforms (P < 0.05). Based on the results of this analysis of randomized trial data, percutaneous PFO closure appears to be a safe and effective therapeutic option for the secondary prevention of ischemic stroke in patients with PFO and cryptogenic stroke. © 2018 Wiley Periodicals, Inc.

[A Case of Laparoscopic Repair of Internal Hernia after Laparoscope-Assisted Distal Gastrectomy with Antecolic Roux-en-Y Reconstruction].

PubMed

Maezawa, Yukio; Cho, Haruhiko; Kano, Kazuki; Nakajima, Tetsushi; Ikeda, Kousuke; Yamada, Takanobu; Sato, Tsutomu; Ohshima, Takashi; Rino, Yasushi; Masuda, Munetaka; Ogata, Takashi; Yoshikawa, Takaki

2017-10-01

A 72-year-old woman had undergone laparoscope-assisted distal gastrectomy with D1 plus lymph node dissection and antecolic Roux-en-Y reconstruction for early gastric cancer. She visited our department outpatient clinic with left upper abdominal pain 1 year and 9 months after the surgery. CT revealed a spiral sign of the superior mesenteric arteriovenous branch. An internal hernia was suspected on hospitalization. Although abdominal symptoms were relieved by conservative treatment, the hernia persisted. Laparoscopic surgery was performed and revealed that almost entire small intestine had been affected due to Petersen's defect. Since no ischemic changes were observed, the defect was repaired laparoscopically with suture closure. There has been no recurrence of internal hernia after the laparoscopic surgery. Internal hernia after distal gastrectomy is relatively rare. However, the risk of internal hernia is high due to the gap between the elevated jejunum and transverse colon mesentery in Roux-en-Y reconstruction and can lead to intestinal necrosis. Since an internal hernia can occur in patients who have undergone gastric resection with Roux-en-Y reconstruction, suture closure of Petersen's defect should be performed to prevent this occurrence.

Patent Ductus Arteriosus closure in preterms less than 2kg: Surgery versus transcatheter.

PubMed

Pamukcu, Ozge; Tuncay, Aydin; Narin, Nazmi; Baykan, Ali; Korkmaz, Levent; Argun, Mustafa; Ozyurt, Abdullah; Sunkak, Suleyman; Uzum, Kazim

2018-01-01

As new devices come into the market, percutaneous techniques improve and interventionalists become more experienced; percutaneous closure gets more common in preterms. In this study we aimed to compare efficacy and safety of Patent Ductus Arteriosus closure surgically versus transcatheter method in preterms <2kg. Best of our knowledge this study is the first one that compares outcomes of surgery and percutaneous Patent Ductus Arteriosus closure in preterms. Between the dates July 1997 to October 2014 in our center Patent Ductus Arteriosus of 26 patients <2kg were closed percutaneously (Group A) and 31 less than 2kg operated (Group B). Weight of patients in percutaneous Patent Ductus Arteriosus closure group was significantly more than the surgery group. Mean gestational age of the patients in Group A was 30±1.8weeks, in group B was 28.6±3.5weeks. In group A; all cases were closed successfully except 4 cases: device embolization in 2, cardiac tamponade and iatrogenic aortic coarctation were seen. Pneumomediastinum and chylothorax were the major complications of the surgery group. There was no statistically significance between complication and success rates between two groups. Percutaneous Patent Ductus Arteriosus closure is the candidate for taking the place of surgery in preterms. However, it is not applied routinely; can only be done in fully equipped large centers by experienced interventionalists. Copyright © 2017 Elsevier B.V. All rights reserved.

Use of the Boomerang catalyst advantage closure device to facilitate complex multistaged percutaneous revascularization procedures for the treatment of critical limb ischemia.

PubMed

Garcia, Joel A; Casserly, Ivan P

2009-07-01

An increasing spectrum of complex peripheral arterial disease may be successfully treated using percutaneous revascularization techniques. A pair of challenging peripheral revascularization procedures in patients with critical limb ischemia is presented, where an array of interventional tools and techniques were required, and the off-label use of the Boomerang catalyst system closure device was important in managing a variety of complex arterial access issues and ultimately allowing procedural success. Copyright 2009 Wiley-Liss, Inc.

Device for testing closure disks at high rates of change of pressure

DOEpatents

Merten, C.W. Jr.

1993-11-09

A device is described for testing the burst pressure of closure disks which provides high pressure to both sides of a disk and rapidly releases pressure from one side thereof causing a high rate of change of pressure. A hollow notched plug allows the rapid release of pressure upon rupturing. A means is also disclosed for transmitting a tensile load from a piston to a hollow notched plug and for sealing the means for transmitting load within a hole in a piston. 5 figures.

Catheter-based closure of the patent ductus arteriosus in lower weight infants.

PubMed

Pavlek, Leeann R; Slaughter, Jonathan L; Berman, Darren P; Backes, Carl H

2018-06-13

Risks associated with drug therapy and surgical ligation have led health care providers to consider alternative strategies for patent ductus arteriosus (PDA) closure. Catheter-based PDA closure is the procedure of choice for ductal closure in adults, children, and infants ≥6kg. Given evidence among older counterparts, interest in catheter-based closure of the PDA in lower weight (<6kg) infants is growing. Among these smaller infants, the goals of this review are to: (1) provide an overview of the procedure; (2) review the types of PDA closure devices; (3) review the technical success (feasibility); (4) review the risks (safety profile); (5) discuss the quality of evidence on procedural efficacy; (6) consider areas for future research. The review provided herein suggests that catheter-based PDA closure is technically feasible, but the lack of comparative trials precludes determination of the optimal strategy for ductal closure in this subgroup of infants. Copyright © 2018 Elsevier Inc. All rights reserved.

Closure of tubular patent ductus arteriosus with the Amplatzer Vascular Plug IV: feasibility and safety.

PubMed

Baruteau, Alban-Elouen; Lambert, Virginie; Riou, Jean-Yves; Angel, Claude-Yves; Belli, Emre; Petit, Jérôme

2015-01-01

Closure of tubular patent ductus arteriosus remains a challenging procedure. Anecdotal use of Amplatzer Vascular Plug IV for tubular ductus closure has been reported but feasibility and safety in a consecutive patients' series remain unknown. We performed a monocenter prospective study at the Marie Lannelongue Hospital in Paris, France. From 2009 to 2014, a total of 47 patients (39 infants, 3 children, and 5 adults) underwent ductus closure with the Plug IV. Ductus morphology was a type E in 34 (72.3%) patients and a type C in 13 (27.7%) patients. Ductus closure occurred in 39 (83.0%) infants at a median age of seven months (range: 3-23 months) and a median weight of 6.9 kg (range: 4.1-17.0 kg). A past history of prematurity and very low birth weight was found in 33 (70.2%) of them. Twelve (25.5%) patients had pulmonary hypertension. Mean Plug IV diameter was 1.9 ± 0.1 mm larger than the mean maximal ductus diameter. Early complete closure of the ductus was obtained in all patients. Early migration of an undersized Plug IV occurred in one (2.1%) patient and was suitable for percutaneous device retrieval. After a mean follow-up of 3.4 ± 1.4 years, all patients are alive and asymptomatic, no late complication occurred. Transcatheter closure of tubular ductus with the Amplatzer Vascular Plug IV can be safe and effective, with a 100% early occlusion rate. This device, suitable for a 4F sheath, is a new alternative for tubular ductus closure in low-body-weight infants. © The Author(s) 2014.

Effect of transcatheter closure of baffle leaks following senning or mustard atrial redirection surgery on oxygen saturations and polycythaemia.

PubMed

Bentham, James; English, Kate; Hares, Dominic; Gibbs, John; Thomson, John

2012-10-01

The aim of this study was to describe the clinical importance and methods of transcatheter closure of systemic venous baffle leaks after atrial redirection procedures for transposed great vessels. Until the late 1970s, atrial redirection surgery was the principal surgical palliative approach to manage transposed great vessels. Baffle leaks are among the many long-term complications of this type of surgery, and their prevalence increases over time. The clinical consequences of baffle leaks in this population are poorly understood, and the indications for closure are incompletely defined. During outpatient follow-up of 126 patients after atrial redirection surgery, 15 baffle leaks were detected in 11 patients. All underwent transcatheter closure using either an occluding device or a covered stent if there was concomitant baffle obstruction. The average age at the time of the procedure was 26 years (range 6 to 42). Ten of 11 patients were cyanosed at rest or on a simple walk test (median oxygen saturation level 80%, range 65% to 96%). Six of 11 patients were polycythemic before leak closure (median hemoglobin concentration 19 g/dl, range 13.8 to 23). After closure, there was a significant improvement in saturation (median 97%, p <0.0001) and a significant reduction in hemoglobin concentration at 6 months after the procedure (median 14.8 g/dl, p <0.05). There were no procedural adverse events. One patient experienced late device embolization necessitating surgical removal. In conclusion, transcatheter closure of baffle leaks is a technically feasible although frequently complex and lengthy procedure. Closure is associated with an improvement in oxygen saturations and a reduction in polycythaemia. Copyright © 2012 Elsevier Inc. All rights reserved.

A comparison of two endoscopic closures: over-the-scope clip (OTSC) versus KING closure (endoloop + clips) in a randomized long-term experimental study.

PubMed

Dolezel, R; Ryska, O; Kollar, M; Juhasova, J; Kalvach, J; Ryska, M; Martinek, J

2016-11-01

Both over-the-scope clip (OTSC) and KING (endoloop + clips) closures provide reliable and safe full-thickness endoscopic closure. Nevertheless, OTSC clip demonstrated significantly inferior histological healing in the short-term follow-up. To compare OTSC versus KING closure of a perforation with regard to long-term effectiveness and macroscopic and histological quality of healing. We performed a randomized experimental study with 16 mini-pigs (mean weight 43.2 ± 11.2 kg). A standardized perforation was performed on the anterior sigmoid wall. KING closure (n = 8) was attained by approximation of an endoloop fixed to the margins of a perforation with endoclips. OTSC closure (n = 8) was performed by deploying OTSC (OVESCO) over the defect. Pigs underwent a control sigmoidoscopy 8 months after the closure to assess the macroscopic quality of healing. Then, autopsy was performed and the rectosigmoid was sent for histopathological assessment. All closures were completed successfully without air leaks. The duration of closure was similar in both techniques (OTSC 17.8 ± 7.6 min vs. KING 19.6 ± 8.8 min). At autopsy, all KING closures (100 %) were healed with a flat scar without signs of leakage. Microscopically, no inflammatory changes were observed after KING closure. In the OTSC group, microscopic ulcers were present in two pigs (25 %), cryptal abscesses in three pigs (38 %) and significant neutrophil accumulation in all eight pigs (P < 0.01). Giant cell granulomas, dysplasia or abundant scarification was not observed in either group. Both OTSC and KING closures offer a long-term reliable seal of a gastrointestinal perforation without stenosis or fistulas. KING closure provides long-term histologically superior healing.

Results of the combined U.S. Multicenter Pivotal Study and the Continuing Access Study of the Nit-Occlud PDA device for percutaneous closure of patent ductus arteriosus.

PubMed

Moore, John W; Greene, Jessica; Palomares, Salvadore; Javois, Alexander; Owada, Carl Y; Cheatham, John P; Hoyer, Mark H; Jones, Thomas K; Levi, Daniel S

2014-12-01

This study aimed to compare the efficacy and safety of the Nit-Occlud PDA device (PFM Medical, Cologne, Germany) to benchmarks designed as objective performance criteria (OPC). The Nit-Occlud PDA is a nitinol coil-type patent ductus arteriosus (PDA) occluder with a reverse cone configuration, which is implanted using a controlled delivery system. Patients with <4-mm minimum diameter PDA were prospectively enrolled in the Pivotal and the Continuing Access Studies from 15 sites in the United States and were followed up for 12 months post-procedure. Investigator-reported outcomes were compared to OPC including a composite success criterion, efficacy criteria of successful closure (clinical and echocardiographic), and safety criteria incidence of adverse events (serious and of total). The Pivotal Study enrolled patients between November 1, 2002 and October 31, 2005, and the Continuing Access Study enrolled additional patients between September 1, 2006 and October 31, 2007. A total of 357 patients were enrolled, and 347 had successful device implantations. After 12 months, 96.8% had complete echocardiographic closure (OPC = 85%) and 98.1% had clinical closure (OPC = 95%). There were no deaths or serious adverse events (OPC = 1%). The total adverse event rate was 4.7% (OPC = 6%). Composite success was 95.1% in the study patients (OPC = 80%). Closure of small- and medium-sized PDA with the Nit-Occlud PDA is effective and safe when compared with OPC. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Hiatal hernia repair with gore bio-a tissue reinforcement: our experience.

PubMed

Antonino, Agrusa; Giorgio, Romano; Giuseppe, Frazzetta; Giovanni, De Vita; Silvia, Di Giovanni; Daniela, Chianetta; Giuseppe, Di Buono; Vincenzo, Sorce; Gaspare, Gulotta

2014-01-01

Type I hiatal hernia is associated with gastroesophageal reflux disease (GERD) in 50-90% of cases. Several trials strongly support surgery as an effective alternative to medical therapy. Today, laparoscopic fundoplication is considered as the procedure of choice. However, primary laparoscopic hiatal hernia repair is associated with upto 42% recurrence rate. Mesh reinforcement of the crural closure decreases the recurrence but can lead to complications, above all nonabsorbable ones. We experiment a new totally absorbable mesh by Gore. Case. We present a case of a 65-year-old female patient with a 6-year classic history of GERD. Endoscopy revealed a large hiatal hernia and esophagitis. pH study was positive for acid reflux; esophageal manometry revealed LES intrathoracic dislocation. With laparoscopic approach, the hiatal hernia defect was identified and primarily repaired, by crural closure. Gore Bio-A Tissue Reinforcement was trimmed to fit the defect accommodating the esophagus. Nissen fundoplication was performed. Result. Bio-A mesh was easily placed laparoscopically. It has good handling and could be cut and tailored intraoperatively for optimal adaptation. There were no short-term complications. Conclusion. Crural closure reinforcement can be done readily with this new totally absorbable mesh replaced by soft tissue over six months. However, further data and studies are needed to evaluate long-term outcomes.

Hiatal Hernia Repair with Gore Bio-A Tissue Reinforcement: Our Experience

PubMed Central

Antonino, Agrusa; Giorgio, Romano; Giuseppe, Frazzetta; Giovanni, De Vita; Silvia, Di Giovanni; Daniela, Chianetta; Giuseppe, Di Buono; Vincenzo, Sorce; Gaspare, Gulotta

2014-01-01

Type I hiatal hernia is associated with gastroesophageal reflux disease (GERD) in 50–90% of cases. Several trials strongly support surgery as an effective alternative to medical therapy. Today, laparoscopic fundoplication is considered as the procedure of choice. However, primary laparoscopic hiatal hernia repair is associated with upto 42% recurrence rate. Mesh reinforcement of the crural closure decreases the recurrence but can lead to complications, above all nonabsorbable ones. We experiment a new totally absorbable mesh by Gore. Case. We present a case of a 65-year-old female patient with a 6-year classic history of GERD. Endoscopy revealed a large hiatal hernia and esophagitis. pH study was positive for acid reflux; esophageal manometry revealed LES intrathoracic dislocation. With laparoscopic approach, the hiatal hernia defect was identified and primarily repaired, by crural closure. Gore Bio-A Tissue Reinforcement was trimmed to fit the defect accommodating the esophagus. Nissen fundoplication was performed. Result. Bio-A mesh was easily placed laparoscopically. It has good handling and could be cut and tailored intraoperatively for optimal adaptation. There were no short-term complications. Conclusion. Crural closure reinforcement can be done readily with this new totally absorbable mesh replaced by soft tissue over six months. However, further data and studies are needed to evaluate long-term outcomes. PMID:24864221

[Vertical rectus abdominis myocutaneous flap for the closure of perineal wound after abdominoperineal resection of the rectum].

PubMed

Orhalmi, J; Vreský, B; Holéczy, P; Jackanin, S; Biath, P

2009-06-01

A major source of morbidity after abdominoperineal resection (APR) after neoadjuvant external beam pelvic radiation are perineal wound complications. Wound complications are common for 25-66% of patients overall. There are many of procedures provided to reconstruct the perineal defect after APR e.g. primary closure, secondary closure, superior gluteal artery flap and vertical rectus abdominus myocutaneous (VRAM) flap. Our purpose was to describe the effect of VRAM flap on reconstruction of perineal wound. VRAM flaps are ideally suited to bring nonirradiated tissue into defect associated with radical surgical extirpation procedures and irradiated fields. This flap, distally based in the deep inferior epigastric vessels, provides several distinct advantages. It is well perfused by the robust dominant pedicle and the deep inferior epigastric artery and vein. In addition, this flap provides adequate muscle bulk to obliterate pelvic dead space. The skin island can be used for resurfacing the perineal region, including the vaginal wall, and provides versatility for all patterns of resection. VRAM flap provides very good aesthetic and functional results, is technically relatively simple and radically decreases wound complications rate. The additional possibility is pull-through the flap transpelvically intraabdominally instead of pull-through via subcutaneous channel, especially with females.

Cor triatriatum dexter and atrial septal defect in a 43-year-old woman.

PubMed

Vukovic, Petar M; Kosevic, Dragana; Milicic, Miroslav; Jovovic, Ljiljana; Stojanovic, Ivan; Micovic, Slobodan

2014-08-01

Cor triatriatum dexter is a rare congenital heart anomaly in which a membrane divides the right atrium into 2 chambers. We report the case of a 43-year-old woman who had cor triatriatum dexter and a large atrial septal defect. During attempted percutaneous closure, the balloon disrupted the membrane and revealed that the defect had no inferior rim, precluding secure placement of an Amplatzer Septal Occluder. Surgical treatment subsequently proved to be successful. In patients with an incomplete membrane and a septal defect with well-defined rims, percutaneous treatment can be the first choice. In patients who have cor triatriatum dexter and unfavorable anatomic features or concomitant complex heart anomalies, open-heart surgery remains the gold standard for treatment.

Cor Triatriatum Dexter and Atrial Septal Defect in a 43-Year-Old Woman

PubMed Central

Kosevic, Dragana; Milicic, Miroslav; Jovovic, Ljiljana; Stojanovic, Ivan; Micovic, Slobodan

2014-01-01

Cor triatriatum dexter is a rare congenital heart anomaly in which a membrane divides the right atrium into 2 chambers. We report the case of a 43-year-old woman who had cor triatriatum dexter and a large atrial septal defect. During attempted percutaneous closure, the balloon disrupted the membrane and revealed that the defect had no inferior rim, precluding secure placement of an Amplatzer Septal Occluder. Surgical treatment subsequently proved to be successful. In patients with an incomplete membrane and a septal defect with well-defined rims, percutaneous treatment can be the first choice. In patients who have cor triatriatum dexter and unfavorable anatomic features or concomitant complex heart anomalies, open-heart surgery remains the gold standard for treatment. PMID:25120397

The aristaless-like homeobox protein Alx3 as an etiopathogenic factor for diabetes mellitus.

PubMed

Vallejo, Mario

2011-01-01

Inactivation of the gene encoding the aristaless-related homeodomain transcription factor Alx3 results in islet cell apoptosis and impaired glucose homeostasis that worsens with age due to the appearance of insulin resistance. Alx3-deficient mice also show extrapancreatic developmental defects with variable penetrance. These include polydactyly, craniofacial midline defects, and neural tube closure defects. In humans, related congenital defects associated with mutations in ALX3 and other aristaless-related genes are being identified. Emerging evidence suggests that normal pancreatic function in humans may require the integrity of aristaless-related genes. Here, the proposal that ALX3 could be considered as a candidate gene for the etiopathogenesis of diabetes or its complications during embryonic or fetal development is discussed.

Comparison of effectiveness and cost of patent ductus arteriosus device occlusion versus surgical ligation of patent ductus arteriosus

PubMed Central

Zulqarnain, Arif; Younas, Muhammad; Waqar, Tariq; Beg, Ahsan; Asma, Touseef; Baig, Mirza Ahmad Raza

2016-01-01

Objectives: Comparison of effectiveness and cost of transcatheter occlusion of patent ductus arteriosus (PDA) with surgical ligation of PDA. Methods: This retrospective comparative study was conducted in the pediatric cardiology department of Ch. Pervaiz Elahi Institute of Cardiology Multan, Pakistan. Data of 250 patients who underwent patent ductus arteriosus (PDA) closure either surgical or trans-catheter closure using SHSMA Occluder having weight >5 kg from April 2012 to October 2015 were included in this study. SPSS version 20 was used for data analysis. Quantitative variables were compared using independent sample t-test. Chi-square test and fishers exact was used for qualitative variables. P-value <0.05 was considered statistically significant. Results: There were one hundred and twenty (120) patients who underwent transcatheter occlusion of PDA using SHSMA occluder (PDA Device Group) and one hundred and thirty (130) patients who underwent surgical ligation of PDA (Surgical Group). Incidence of residual shunting was two (1.5%) in surgical group and 0 (0.0%) in PDA Device group for one month follow up period. There were 4 (3.1%) major complications in surgical group. The rate of blood transfusions were high in surgical group (p-value 0.04). Hospital stay time was significantly less in PDA Device group (P-value <0.001). Total procedural cost was 110695+1054 Pakistani rupees in PDA Device group and 92414+3512 in surgical group (p-value <0.001). The cost of PDA device closure was 16.52% higher than the surgical ligation of PDA. There was no operative mortality. Conclusion: The transcatheter closure of PDA is an effective and less invasive method as compared to the surgical ligation. There is a lower rate of complications and the cost is not much high as compared to surgical PDA ligation. PMID:27648051

Electron-beam-induced information storage in hydrogenated amorphous silicon device

DOEpatents

Yacobi, Ben G.

1986-01-01

A method for recording and storing information in a hydrogenated amorphous silicon device, comprising: depositing hydrogenated amorphous silicon on a substrate to form a charge-collection device; and generating defects in the hydrogenated amorphous silicon device, wherein the defects act as recombination centers that reduce the lifetime of carriers, thereby reducing charge-collection efficiency; and thus in the charge-collection mode of scanning probe instruments, regions of the hydrogenated amorphous silicon device that contain the defects appear darker in comparison to regions of the device that do not contain the defects, leading to a contrast formation for pattern recognition and information storage, in the device, which darkened areas can be restored to their original charge-collection efficiency by heating the hydrogenated amorphous silicon to a temperature of about 100.degree. C. to 250.degree. C. for a sufficient period of time to provide for such restoration.

49 CFR 221.17 - Movement of defective equipment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Movement of defective equipment. 221.17 Section... Marking Devices § 221.17 Movement of defective equipment. (a) Whenever the marking device prescribed in... of the defect, can be placed only at the rear of a train for movement to the next forward location at...

Transcatheter closure of patent ductus arteriosus: 11 years of clinical experience in Cipto Mangunkusumo Hospital, Jakarta, Indonesia.

PubMed

Djer, Mulyadi M; Saputro, Dimas Dwi; Putra, Sukman Tulus; Idris, Nikmah Salamia

2015-06-01

Transcatheter closure of patent ductus arteriosus (PDA) has been suggested to be the standard treatment of PDA. Although, in general, the procedure shows a high successful rate, outcomes may vary among pediatric cardiology centers. To evaluate the effectiveness of transcatheter closure of PDA in Cipto Mangunkusumo Hospital, Jakarta, Indonesia, this was a retrospective study on patients who underwent transcatheter closure of PDA in Cipto Mangunkusumo Hospital during the period of 2002-2013. Hospital registry was reviewed and data about patients' characteristics, PDA severity, procedure, and outcomes were retrieved. There were 298 patients, of whom 90 were males, who underwent transcatheter closure of PDA during the study period. Median age was 3.4 years (1 months-18 years), and median body weight was 12 (3.6-59) kg. The diameter of PDA ranged from 1.1 to 15.4 mm with a median of 3.7 mm. Device could be deployed in all patients, in which most were the Amplatzer ductal occluder (69.8 %) and the remainders were coils. Median fluoroscopy time was 15.4 (1.5-87) min, and procedure time was 76 (30-200) min. Complete closure was achieved in most patients (97.3 %), whereas device migration occurred in a minority (0.3 %) of patients. No major complication occurred during or after the procedure. Transient anemia and bradycardia were found in 3.7 and 1.3 % patients, respectively. Most patients were discharged from the hospital at 1 day after the procedure. Transcatheter closure method is a safe and effective procedure to close PDA.

New devices and techniques for endoscopic closure of gastrointestinal perforations

PubMed Central

Li, Yue; Wu, Jian-Hua; Meng, Yan; Zhang, Qiang; Gong, Wei; Liu, Si-De

2016-01-01

Gastrointestinal perforations, which need to be managed quickly, are associated with high morbidity and mortality. Treatments used to close these perforations range from surgery to endoscopic therapy. Nowadays, with the development of new devices and techniques, endoscopic therapy is becoming more popular. However, there are different indications and clinical efficacies between different methods, because of the diverse properties of endoscopic devices and techniques. Successful management also depends on other factors, such as the precise location of the perforation, its size and the length of time between the occurrence and diagnosis. In this study, we performed a comprehensive review of various devices and introduced the different techniques that are considered effective to treat gastrointestinal perforations. In addition, we focused on the different methods used to achieve successful closure, based on the literature and our clinical experiences. PMID:27672268

Mutation of SALL2 causes recessive ocular coloboma in humans and mice

PubMed Central

Kelberman, Daniel; Islam, Lily; Lakowski, Jörn; Bacchelli, Chiara; Chanudet, Estelle; Lescai, Francesco; Patel, Aara; Stupka, Elia; Buck, Anja; Wolf, Stephan; Beales, Philip L.; Jacques, Thomas S.; Bitner-Glindzicz, Maria; Liasis, Alki; Lehmann, Ordan J.; Kohlhase, Jürgen; Nischal, Ken K.; Sowden, Jane C.

2014-01-01

Ocular coloboma is a congenital defect resulting from failure of normal closure of the optic fissure during embryonic eye development. This birth defect causes childhood blindness worldwide, yet the genetic etiology is poorly understood. Here, we identified a novel homozygous mutation in the SALL2 gene in members of a consanguineous family affected with non-syndromic ocular coloboma variably affecting the iris and retina. This mutation, c.85G>T, introduces a premature termination codon (p.Glu29*) predicted to truncate the SALL2 protein so that it lacks three clusters of zinc-finger motifs that are essential for DNA-binding activity. This discovery identifies SALL2 as the third member of the Drosophila homeotic Spalt-like family of developmental transcription factor genes implicated in human disease. SALL2 is expressed in the developing human retina at the time of, and subsequent to, optic fissure closure. Analysis of Sall2-deficient mouse embryos revealed delayed apposition of the optic fissure margins and the persistence of an anterior retinal coloboma phenotype after birth. Sall2-deficient embryos displayed correct posterior closure toward the optic nerve head, and upon contact of the fissure margins, dissolution of the basal lamina occurred and PAX2, known to be critical for this process, was expressed normally. Anterior closure was disrupted with the fissure margins failing to meet, or in some cases misaligning leading to a retinal lesion. These observations demonstrate, for the first time, a role for SALL2 in eye morphogenesis and that loss of function of the gene causes ocular coloboma in humans and mice. PMID:24412933

In vitro comparison of intra-abdominal hypertension development after different temporary abdominal closure techniques.

PubMed

Benninger, Emanuel; Labler, Ludwig; Seifert, Burkhardt; Trentz, Otmar; Menger, Michael D; Meier, Christoph

2008-01-01

To compare volume reserve capacity (VRC) and development of intra-abdominal hypertension after different in vitro temporary abdominal closure (TAC) techniques. A model of the abdomen was designed. The abdominal wall was simulated with polychloroprene, a synthetic rubber compound. A lentil-shaped defect of 150 cm(2) was cut into the anterior aspect of the abdominal wall. TAC of this defect was performed by a zipper system (ZS), a bag silo closure (BSC), or a vacuum assisted closure (VAC) with subatmospheric pressures ranging from 0- to 200 mmHg. The model with intact abdominal wall served as reference. The model was filled with water to baseline level. The intra-abdominal pressure was increased in 2 mmHg steps from baseline level (6 mmHg) to 40 mmHg by adding volume to the system according to a standardized protocol. VRC with corresponding intra-abdominal pressure were analyzed and compared for the different TAC techniques. VRC was the highest after BSC at all pressure levels studied (P < 0.05). VAC and ZS resulted in significantly lower VRC compared with BSC and reference (P < 0.05). The magnitude of negative pressure on the VAC did not significantly influence the VRC. In the present in vitro model, BSC demonstrated the highest VRC of all evaluated TAC techniques. Different levels of subatmospheric pressures applied to the VAC did not affect VRC. The results for ZS and VAC indicate that these TAC techniques may increase the risk for recurrent intra-abdominal hypertension and should therefore not be used in high-risk patients during the initial phase after abdominal decompression.

Successful use of a left ventricular apical access and closure device for second-generation transapical aortic valve implantation.

PubMed

Conradi, Lenard; Seiffert, Moritz; Shimamura, Kazuo; Schirmer, Johannes; Blankenberg, Stefan; Reichenspurner, Hermann; Diemert, Patrick; Treede, Hendrik

2014-09-01

Transcatheter aortic valve implantation (TAVI) has become routine for the treatment of high-risk patients with aortic stenosis. We assessed safety and feasibility of a left ventricular apical access and closure device combined with second-generation transapical (TA) TAVI transcatheter heart valves (THV). Three elderly, comorbid patients (logEuroSCORE I 13.0-31.1%) received transapical aortic valve implantation (TA-AVI) via the Apica ASC device (Apica Cardiovascular Ltd., Galway, Ireland) using second-generation THV (Medtronic Engager [Medtronic 3F Therapeutics, Santa Ana, California, United States], JenaValve [JenaValve Technology GmbH, Munich, Germany], Symetis Acurate [Symetis S.A., Ecublens, Switzerland]). Access was gained using a non-rib-spreading technique and a novel access and closure device. THV deployment was successful with excellent hemodynamic outcome (no PVL, n = 2; trace PVL, n = 1; mean transvalvular gradients, 5-19 mm Hg) and complete apical hemostasis. No periprocedural major adverse events occurred and Valve Academic Research Consortium-2-defined composite end point of device success was met in all cases. Safety and feasibility of TA-AVI using the ASC device with second-generation THV was demonstrated. Combining latest available technology is a major step toward improved functional outcome and decreased surgical trauma in TA-AVI. Potentially, technical enhancements may eventually pave the way toward a fully percutaneous TA-AVI procedure. Georg Thieme Verlag KG Stuttgart · New York.

Laceration of the Common Femoral Artery Following Deployment of the StarClose{sup TM} Vascular Closure System

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gonsalves, Michael, E-mail: drmag1975@gmail.com; Walkden, Miles, E-mail: rwalkden@nhs.net; Belli, Anna Maria, E-mail: Anna.Belli@stgeorges.nhs.u

2008-07-15

StarClose is a novel arterial closure device which achieves hemostasis, following arteriotomy, via a nitinol clip deployed on the outer arterial wall. Since its introduction to the market, several studies have shown StarClose to be both safe and effective, with few major complications encountered. We report a case of common femoral artery laceration following deployment of the StarClose vascular closure system. We conclude that the injury occurred secondary to intravascular misplacement of the nitinol clip.

Transcatheter device closure of pseudoaneurysms of the left ventricular wall: An emerging therapeutic option.

PubMed

Madan, Tarun; Juneja, Manish; Raval, Abhishek; Thakkar, Bhavesh

2016-02-01

Left ventricular pseudoaneurysm is a rare but serious complication of acute myocardial infarction and cardiac surgery. While surgical intervention is the conventional therapeutic option, transcatheter closure can be considered in selected patients with suitable morphology of the pseudoaneurysm. We report a case of successful transcatheter closure of a left ventricular pseudoaneurysm orifice and isolation of the sac using an Amplatzer septal occluder. Copyright © 2016 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

Transcatheter Closure of Patent Foramen Ovale in Patients with Platypnea-Orthodeoxia: Results of a Multicentric French Registry

DOE Office of Scientific and Technical Information (OSTI.GOV)

Guerin, P.; Lambert, V.; Godart, F.

Background. Dyspnea and the decrease in arterial saturation in the upright position in elderly subjects is described as platypnea-orthodeoxia syndrome (POS). POS is secondary to the occurrence of an atrial right-to-left shunt through a patent foramen ovale (PFO). Methods. This French multicentric study reports on 78 patients (mean age 67 {+-} 11.3 years) with POS who had transcatheter closure of the PFO; frequently associated diseases were pneumonectomy (n = 36) and an ascending aortic aneurysm (n = 11). In all patients, the diagnosis was confirmed by transthoracic or/and transesophageal echocardiography. Five different closure devices were used: Amplatz (n = 45),more » Cardioseal (n = 13), Sideris (n = 11), Das Angel Wings (n = 8) and Starflex (n = 1). Closure was successful in 76 patients (97%). Results. Oxygen saturation increased immediately after occlusion from 84.6 {+-} 10.7% to 95.1 {+-} 6.4% (p < 0.001) and dyspnea improved from grade 2.7 {+-} 0.7 to grade 1 {+-} 1 (p < 0.001). A small residual shunt was immediately observed in 5 patients (3 with the Cardioseal device, 1 with the Sideris and 1 with the Amplatz) leading to the implantation of a second device in one case (Cardioseal). Two early deaths occurred unrelated to the procedure (one due to sepsis probably related to pneumonectomy, another due to respiratory insufficiency). Other complications were: a small shunt between the aorta and the left atrium, two atrial fibrillations and a left-sided thrombus which disappeared with anticoagulant therapy. At a mean follow-up of 15 {+-} 12 months, there were 7 late deaths related to the underlying disease. Conclusion. Percutaneous occlusion of the foramen ovale is safe and gives excellent results thanks to continuing improvement in available devices. This technique enables some patients in an unstable condition to avoid a surgical closure.« less

Reconstruction of posterior neck and skull with vertical trapezius musculocutaneous flap

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mathes, S.J.; Stevenson, T.R.

1988-10-01

The vertical trapezius musculocutaneous flap has been successfully utilized for reconstruction in 13 patients with complex posterior skull and neck defects. This flap based on its vascular pedicle, the descending branch of the transverse cervical artery, provides well-vascularized tissue for coverage of defects related to chronic osteomyelitis, tumor extirpation, osteoradionecrosis, and dehisced cervical laminectomy wounds. Emphasis on flap design, including the location of the skin island, allows adequate wound coverage, direct donor site closure, and muscle function preservation. With its large size and wide arc of rotation, the vertical trapezius musculocutaneous flap provides reliable coverage for posterior trunk, cervical, andmore » skull defects.« less

Dura covered with fibrin glue reduces adhesions in abdominal wall defects.

PubMed

Schier, F; Srour, N; Waldschmidt, J

1991-12-01

Dura can greatly facilitate the closure of abdominal wall defects. However, a main disadvantage of its use are the adhesions which develop between omentum, bowel and dura and may lead to bowel obstructions. In this study various groups of rats had either the anterior wall replaced by untreated dura or by dura covered with fibrin glue prior to implantation. Adhesions were found in 75% of sham operated rats, 100% after untreated dura implantation and 50% after the implantation of fibrin glue treated dura.

Iatrogenic Aortic Valve Perforation after Ventricular Septal Defect Repair

PubMed Central

Ren, Chonglei; Wang, Mingyan; Wang, Yao; Gao, Changqing

2017-01-01

Iatrogenic aortic valve (AV) perforation during non-aortic cardiac operations is a rare complication. The suture-related inadvertent injury to an AV leaflet can produce leaflet perforation with aortic regurgitation after ventricular septal defect repair (VSDR). We report three consecutive patients who had iatrogenic aortic leaflet perforation during VSDR in other hospitals and referred to our hospital for reoperation. In all three cases, the perforated AV leaflets were preserved and repaired by autologous pericardial patch or direct local closure. PMID:29057770

Automatic cross-sectioning and monitoring system locates defects in electronic devices

NASA Technical Reports Server (NTRS)

Jacobs, G.; Slaughter, B.

1971-01-01

System consists of motorized grinding and lapping apparatus, sample holder, and electronic control circuit. Low power microscope examines device to pinpoint location of circuit defect, and monitor displays output signal when defect is located exactly.

A new cable-tie based sternal closure system: description of the device, technique of implantation and first clinical evaluation

PubMed Central

2012-01-01

Background Wire closure still remains the preferred technique despite reasonable disadvantages. Associated complications, such as infection and sternal instability, cause time- and cost-consuming therapies. We present a new tool for sternal closure with its first clinical experience and results. Methods The sternal ZipFixTM System is based on the cable-tie principle. It primarily consists of biocompatible Poly-Ether-Ether-Ketone implants and is predominantly used peristernally through the intercostal space. The system provides a large implant-to-bone contact for better force distribution and for avoiding bone cut through. Results 50 patients were closed with the ZipFixTM system. No sternal instability was observed at 30 days. Two patients developed a mediastinitis that necessitated the removal of the device; however, the ZipFixTM were intact and the sternum remained stable. Conclusions In our initial evaluation, the short-term results have shown that the sternal ZipFixTM can be used safely and effectively. It is fast, easy to use and serves as a potential alternative for traditional wire closure. PMID:22731778

Pilonidal sinus disease surgery in children: the first study to compare crystallized phenol application to primary excision and closure.

PubMed

Ates, Ufuk; Ergun, Ergun; Gollu, Gulnur; Sozduyar, Sumeyye; Kologlu, Meltem; Cakmak, Murat; Dindar, Huseyin; Yagmurlu, Aydin

2018-03-01

Pilonidal sinus (PS) is an infectious and inflammatory disease of sacrococcygeal region. Current methods include; surgical excision with/without suturing the defect, rhomboid excision and flap and chemical substance application. In this study, crystallized phenol application was compared to excision and primary closure. This retrospective study included pediatric patients with PS who were treated with excision and primer closure technique and phenol application. The patients' medical data were analyzed retrospectively. This study included 117 patients with PS. There were 52 girls (44%) and 65 boys (56%). Mean age of children was 15.6 (12-20) years. Excision and primary closure were applied to 77 patients (66%) and phenol was applied to 40 patients (34%). The children in phenol group were discharged on the operation day; mean hospitalization time in the excision and primary closure group was 2.7 (1-14) days. Mean follow up was 44.6 (8-82) months for primary excision and closure group and 8.1 (1-19) months for phenol group. Although many surgical and non-surgical treatment modalities have been described for PS, the optimal one remains unknown. Limited with the retrospective nature of the data, crystallized phenol application seems a feasible minimal invasive alternative to primary closure of PS with lower recurrence and complication rates in children. Level III. Copyright © 2017 Elsevier Inc. All rights reserved.

Percutaneous fetoscopic closure of large open spina bifida using a bilaminar skin substitute.

PubMed

Lapa Pedreira, Denise A; Acacio, Gregório L; Gonçalves, Rodrigo T; Sá, Renato Augusto M; Brandt, Reynaldo A; Chmait, Ramen; Kontopoulos, Eftichia; Quintero, Ruben A

2018-01-04

We have previously described our percutaneous fetoscopic technique for the treatment of open spina bifida (OSB). However, approximately 20-30% of OSB defects are too large to allow primary skin closure. We hereby describe a modification of our standard technique using a bilaminar skin substitute to allow closure of such large spinal defects. The aim of this study was to report our clinical experience with the use of a bilaminar skin substitute and a percutaneous fetoscopic technique for the prenatal closure of large spina bifida defects. Surgeries were performed between 24.0 and 28.9 gestational weeks under general anesthesia, using an entirely percutaneous fetoscopic approach with partial CO2 insufflation of the uterine cavity, as previously described. If there was enough skin to be sutured in the midline, only a biocellulose patch was placed over the placode. In cases where skin approximation was not possible, a bilaminar skin substitute (two layers: one silicone and one dermal matrix) was placed over the biocellulose. The surgical site was assessed at birth, and long-term follow-up was performed. Forty-seven consecutive fetuses underwent percutaneous fetoscopic OSB repair. Premature preterm rupture of membranes (PPROM) occurred in 38 (84%), and the mean gestational age at delivery was 32,8 + 2.5 weeks. A bilaminar skin substitute was required in 13 (29%), of which 5 was associated with myeloschisis. In all cases the skin substitute was found at the surgical site, at birth. In 3 (15%) of these cases, postnatal additional repair was needed. In the other 10 cases, the silicone layer detached spontaneously from the dermal matrix (average 25 days after birth), and the lesion healed by secondary-intention. Operating time was significantly longer in cases requiring the bilaminar skin substitute (additional 42 minutes). The subgroup with bilaminar skin substitute had similar PPROM rate and delivery gestational age compared to the one patch group. Complete reversal of hindbrain herniation occurred in 68% of the one patch and in 33% (p < 0.05) of the two patches group. In 4 cases there was no reversal and 3 of them were myeloschisis cases. Large OSB defects may be successfully treated in utero using a bilaminar skin substitute over a biocellulose patch through an entirely percutaneous approach. Although the operating time is longer, surgical outcomes are similar to cases closed primarily. Myeloschisis seems to have a worse prognosis then myelomeningocele cases. PPROM and preterm birth continue to be a challenge. Further experience is needed to assess the risks and benefits of this technique for management of large OSB defects. This article is protected by copyright. All rights reserved.

Divided and Sliding Superficial Temporal Artery Flap for Primary Donor-site Closure

PubMed Central

Sugio, Yuta; Seike, Shien; Hosokawa, Ko

2016-01-01

Summary: Superficial temporal artery (STA) flaps are often used for reconstruction of hair-bearing areas. However, primary closure of the donor site is not easy when the size of the necessary skin island is relatively large. In such cases, skin grafts are needed at the donor site, resulting in baldness. We have solved this issue by applying the divided and sliding flap technique, which was first reported for primary donor-site closure of a latissimus dorsi musculocutaneous flap. We applied this technique to the hair-bearing STA flap, where primary donor-site closure is extremely beneficial for preventing baldness consequent to skin grafting. The STA flap was divided into 3, and creation of large flap was possible. Therefore, we concluded that the divided and sliding STA flap could at least partially solve the donor-site problem. Although further investigation is necessary to validate the maximum possible flap size, this technique may be applicable to at least small defects that are common after skin cancer ablation or trauma. PMID:27975020

Quality of life assessment in the randomized PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial of patients at risk for stroke with nonvalvular atrial fibrillation.

PubMed

Alli, Oluseun; Doshi, Shepal; Kar, Saibal; Reddy, Vivek; Sievert, Horst; Mullin, Chris; Swarup, Vijay; Whisenant, Brian; Holmes, David

2013-04-30

This study sought to assess quality of life parameters in a subset of patients enrolled in the PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial. The PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial demonstrated that in patients with nonvalvular atrial fibrillation (AF) and CHADS2 (congestive heart failure, hypertension, age, diabetes mellitus, and prior stroke, transient ischemic attack, or thromboembolism) score ≥1, a left atrial appendage closure device is noninferior to long-term warfarin for stroke prevention. Given this equivalency, quality of life (QOL) indicators are an important metric for evaluating these 2 different strategies. QOL using the Short-Form 12 Health Survey, version 2, measurement tool was obtained at baseline and 12 months in a subset of 547 patients in the PROTECT AF trial (361 device and 186 warfarin patients). The analysis cohort consisted of patients for whom either paired quality of life data were available after 12 months of follow-up or for patients who died. With the device, the total physical score improved in 34.9% and was unchanged in 29.9% versus warfarin in whom 24.7% were improved and 31.7% were unchanged (p = 0.01). Mental health improvement occurred in 33.0% of the device group versus 22.6% in the warfarin group (p = 0.06). There was a significant improvement in QOL in patients randomized to device for total physical score, physical function, and in physical role limitation compared to control. There were significant differences in the change in total physical score among warfarin naive and not-warfarin naive subgroups in the device group compared to control, but larger gains were seen with the warfarin naive subgroup with a 12-month change of 1.3 ± 8.8 versus -3.6 ± 6.7 (p = 0.0004) device compared to warfarin. Patients with nonvalvular AF at risk for stroke treated with left atrial appendage closure have favorable QOL changes at 12 months versus patients treated with warfarin. (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation [WATCHMAN PROTECT]; NCT00129545). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Patent foramen ovale closure and migraine: science and sensibility.

PubMed

Gupta, Vinod Kumar

2010-09-01

Migraine has been associated with patent foramen ovale (PFO), and PFO closure has become the most high-profile nonpharmacologic invasive therapy recommended for the prevention of recurrent migraine attacks, as well as for preventing further attacks in cryptogenic stroke. The results of Migraine Intervention with STARFlex Technology (MIST), a controversial but important recent randomized clinical trial (RCT) of PFO closure for migraine, do not support PFO closure for preventing migraine attacks. All patients with migraine, however, do not have a PFO, and the characteristic periodicity and predictability of migraine cannot be explained on the basis of paradoxical embolism through the PFO. Closure of the PFO or atrial septal defect can aggravate migraine suddenly. PFO increases in size with age, but migraine generally subsides with the passage of years. Serendipity does play a role in some medical discoveries, but in the absence of a logically defensible theoretical basis, chance and statistics can both become misleading. With soft end points, RCTs in migraine patients can generate conflicting and irreconcilable data. RCTs cannot supplant or substitute clinical common sense or justify serendipity. Scientific progress mandates that any serendipitous research must ultimately conform to the principles of the basic sciences surrounding the chance discovery. PFO closure for preventing migraine attacks is an unfortunate, but sobering, chapter in the migraine research saga.

Percutaneous closure of patent foramen ovale and atrial septal defect in adults: the impact of clinical variables and hospital procedure volume on in-hospital adverse events.

PubMed

Opotowsky, Alexander R; Landzberg, Michael J; Kimmel, Stephen E; Webb, Gary D

2009-05-01

Percutaneous closure of patent foramen ovale/atrial septal defect (PFO/ASD) is an increasingly common procedure perceived as having minimal risk. There are no population-based estimates of in-hospital adverse event rates of percutaneous PFO/ASD closure. We used nationally representative data from the 2001-2005 Nationwide Inpatient Sample to identify patients >or-=20 years old admitted to an acute care hospital with an International Classification of Diseases, Ninth Revision code designating percutaneous PFO/ASD closure on the first or second hospital day. Variables analyzed included age, sex, number of comorbidities, year, same-day use of intracardiac or other echocardiography, same-day left heart catheterization, hospital size and teaching status, PFO/ASD procedural volume, and coronary intervention volume. Outcomes of interest included length of stay, charges, and adverse events. The study included 2,555 (weighted to United States population: 12,544 +/- 1,987) PFO/ASD closure procedures. Mean age was 52.0 +/- 0.4 years, and 57.3% +/- 1.0% were women. Annual hospital volume averaged 40.8 +/- 7.7 procedures (range, 1-114). Overall, 8.2 +/- 0.8% of admissions involved an adverse event. Older patients and those with comorbidities were more likely to sustain adverse events. Use of intracardiac echocardiography was associated with fewer adverse events. The risk of adverse events was inversely proportional to annual hospital volume (odds ratio [OR] 0.91, 95% confidence interval [CI] 0.86-0.96, per 10 procedures), even after limiting the analysis to hospitals performing >or=10 procedures annually (OR 0.91, 95% CI 0.85-0.98). Adverse events were more frequent at hospitals in the lowest volume quintile as compared with the highest volume quintile (13.3% vs 5.4%, OR 2.42, 95% CI 1.55-3.78). The risk of adverse events of percutaneous PFO/ASD closure is inversely correlated with hospital volume. This relationship applies even to hospitals meeting the current guidelines, performing >or=10 procedures annually.

Cost savings associated with prevention of recurrent lumbar disc herniation with a novel annular closure device: a multicenter prospective cohort study.

PubMed

Parker, Scott L; Grahovac, Gordan; Vukas, Duje; Ledic, Darko; Vilendecic, Milorad; McGirt, Matthew J

2013-09-01

Same-level recurrent disc herniation is a well-defined complication following lumbar discectomy. Reherniation results in increased morbidity and health care costs. Techniques to reduce these consequences may improve outcomes and reduce cost after lumbar discectomy. In a prospective cohort study, we set out to evaluate the cost associated with surgical management of recurrent, same-level lumbar disc herniation following primary discectomy. Forty-six consecutive European patients undergoing lumbar discectomy for a single-level herniated disc at two institutions were prospectively followed with clinical and radiographic evaluations. A second consecutive cohort of 30 patients undergoing 31 lumbar discectomies with implantation of an annular closure device was followed at the same hospitals and same follow-up intervals. Cost estimates for reherniation were modeled on Medicare national allowable payment amounts (direct cost) and patient work-day losses (indirect cost). Annular closure and control cohorts were matched at baseline. By 2 years follow-up, symptomatic recurrent same-level disc herniation occurred in three (6.5%) patients in the control cohort versus zero (0%) patients in the annular closure cohort. For patients experiencing recurrent disc herniation, mean estimated direct and indirect cost of management of recurrent disc herniation was $34,242 and $3,778, respectively. Use of an annular closure device potentially results in a cost savings of $222,573 per 100 primary discectomy procedures performed (or $2,226 per discectomy), based solely on the reduction of reoperated reherniations when modeled on U.S. Medicare costs. Recurrent disc herniation did not occur in any patients after annular closure within the 12-month follow-up. The reduction in the incidence of reherniation was associated with potentially significant cost savings. Development of novel techniques to prevent recurrent lumbar disc herniation is warranted to decrease the associated morbidity and health care costs associated with this complication. Georg Thieme Verlag KG Stuttgart · New York.

Prospective evaluation of the feasibility, safety, and efficacy of Cocoon Duct Occluder for transcatheter closure of large patent ductus arteriosus: A single-center study with short- and medium-term follow-up results

PubMed Central

Sinha, Santosh Kumar; Razi, Mahmadula; Pandey, Rama Niwas; Kumar, Prakash; Krishna, Vinay; Jha, Mukesh Jitendra; Mishra, Vikas; Asif, Mohammad; Abdali, Nasar; Tewari, Pradyot; Thakur, Ramesh; Pandey, Umeshwar; Varma, Chandra Mohan

2017-01-01

Objective: To evaluate the feasibility, safety, and efficacy of a novel Cocoon Duct Occluder device for the transcatheter closure (TCC) of large patent ductus arteriosus (PDA). Methods: In this prospective, non-randomized study, consecutive patients with large PDA (narrowest diameter: ≥3.5/4.0 mm in symptomatic/asymptomatic patients, respectively), who underwent TCC with Cocoon Duct Occluder at our institute between November, 2012 and June, 2016 were examined. TCC was performed using the standard technique, and devices were antegradely delivered via 6–10F delivery sheaths. Device embolization, residual shunt, hemolysis, left pulmonary artery (LPA) stenosis, procedural and fluoroscopy time, and mortality were assessed. Patients were followed-up by transthoracic echocardiography with color Doppler imaging at 24 h (D1), 1 month (D30), and 6 months (D180) after implantation. Results: A total of 57 patients (age: 11.7±2.8 years; weight: 22.3±3.5 kg) were enrolled. The mean narrowest diameter was 7.4±0.7 mm. The PDA closure was successfully performed in each patient. Fluoroscopy and procedural time was 6.7±3.2 min and 23.9±2.7 min, respectively. Postprocedural angiography revealed that 49 (85.9%) patients had immediate and complete closure, whereas 8 (14.1%) had residual shunt. Color Doppler imaging at D1 revealed complete closure in 52 (91.3%) patients. At D30, complete closure was reported in all patients and was maintained at D180. Hemolysis, embolization, obstruction of LPA or descending aorta, and death were not reported till D180. Conclusion: TCC using Cocoon Duct Occluder is feasible, safe, and effective in the management of patients with large PDA, with excellent results on short- and medium-term follow-up. PMID:29145233

Management of hidradenitis suppurativa wounds with an internal vacuum-assisted closure device.

PubMed

Chen, Y Erin; Gerstle, Theodore; Verma, Kapil; Treiser, Matthew D; Kimball, Alexandra B; Orgill, Dennis P

2014-03-01

Hidradenitis suppurativa is a chronic, debilitating disease that is difficult to treat. Once medical management fails, wide local excision offers the best chance for cure. However, the resultant wound often proves too large or contaminated for immediate closure. The authors performed a retrospective chart review of hidradenitis cases managed surgically between 2005 and 2010. Data collected included patient characteristics, management method, and outcomes. Approximately half of the patients received internal vacuum-assisted closure therapy using the vacuum-assisted closure system and delayed closure and half of the patients received immediate primary closure at the time of their excision. Delayed closure consisted of closing the majority of the wound in a linear fashion following internal vacuum-assisted closure while accepting healing by means of secondary intention for small wound areas. Patients managed with internal vacuum-assisted closure had wounds on average four times larger in area than patients managed without internal vacuum-assisted closure. In both groups, all wounds were eventually closed primarily. Healing times averaged 2.2 months with internal vacuum-assisted closure and 2.7 months without. At an average follow-up time of 2.3 months, all patients with internal vacuum-assisted closure had no recurrence of their local disease. Severe hidradenitis presents a treatment challenge, as surgical excisions are often complicated by difficult closures and unsatisfactory recurrence rates. This study demonstrates that wide local excision with reasonable outcomes can be achieved using accelerated delayed primary closure. This method uses internal vacuum-assisted closure as a bridge between excision and delayed primary closure, facilitating closure without recurrence in large, heavily contaminated wounds. Therapeutic, III.

Causes and consequences of anterior pharyngeal pouch after total laryngectomy.

PubMed

Anderson, S; Hogan, D; Panizza, B

2014-07-01

To assess the frequency of anterior pharyngeal pouch formation after total laryngectomy, and to discuss the causes and consequences of anterior pharyngeal pouch formation. A prospective, observational study of 43 patients undergoing total laryngectomy. Data collected included laryngeal defect closure type, tumour staging and demographic information. A barium swallow was performed on day 7-14 after surgery to assess for anterior pharyngeal pouch formation and fistula formation. The incidence of anterior pharyngeal pouch formation was 47 per cent. Patients who did not have an anterior pharyngeal pouch on swallow imaging assessment were less likely to develop a pharyngo-cutaneous fistula. There was no statistically significant association between laryngeal defect closure type and anterior pharyngeal pouch formation. The anterior pharyngeal pouch is a dynamic phenomenon best investigated with a fluoroscopic swallow imaging study. Its causes are multi-factorial. Absence of an anterior pharyngeal pouch appears to confer protection against pharyngo-cutaneous fistula formation, hastening commencement of adjuvant therapy and an oral diet.

Incremental cost-effectiveness of percutaneous versus surgical closure of atrial septal defects in children under a public health system perspective in Brazil.

PubMed

Costa, Rodrigo; Pedra, Carlos A C; Ribeiro, Marcelo; Pedra, Simone; Ferreira-Da-Silva, André Luis; Polanczyk, Carisi; Berwanger, Otávio; Biasi, Alexandre; Ribeiro, Rodrigo

2014-11-01

Cost-effectiveness (CE) studies of percutaneous (PC) versus surgical (SC) atrial septal defect closure are lacking. A systematic literature review in children and a CE analysis based on a model of long-term outcomes were performed. Direct costs of PC and SC were US$8700 (defined arbitrarily) and US$5700 (actually paid), respectively. Three-times the Brazilian GDI (US$28,700) per year of life saved (with a discount rate of 5%) was used as a limit for willingness-to-pay. PC had a high (US$104,500) incremental CE ratio despite lower complication rates, shorter hospital stay and better (nonsignificant) adjusted life expectancy. PC would be cost-effective if it cost US$6400 or SC had an 8% loss of utility or its indirect costs were US$2250. Costs of PC should be reduced to be cost-effective in the Brazilian public health system. Indirect costs and impact on quality of life should be further assessed.

Reverse saphenous conduit flap in small animals: Clinical applications and outcomes.

PubMed

Elliott, Ross C

2014-08-20

Due to the lack of skin elasticity defects of the distal hind limb can be a challenge to close. This article assesses a well-described, but completely under-used technique for closure of wounds on the distal tarsus. The technique was used with good success in six cases presenting to the Bryanston Veterinary Hospital with a wide range of underlying pathology ranging from trauma to neoplastic disease of the tarsus. All six cases were treated with a reverse saphenous conduit flap and two of them underwent radiation therapy with no adverse side effects. All cases showed excellent results with a very low degree of flap necrosis that never exceeded 15% of the total flap area. This skin flap provides an excellent treatment method that is reliable in closure of defects of the distal tarsus with few adverse effects. To the author's knowledge there has been only one previously published report on the clinical use of this type of skin flap, even though the flap is well described in most texts.

Regulation of cell protrusions by small GTPases during fusion of the neural folds

PubMed Central

Rolo, Ana; Savery, Dawn; Escuin, Sarah; de Castro, Sandra C; Armer, Hannah EJ; Munro, Peter MG; Molè, Matteo A; Greene, Nicholas DE; Copp, Andrew J

2016-01-01

Epithelial fusion is a crucial process in embryonic development, and its failure underlies several clinically important birth defects. For example, failure of neural fold fusion during neurulation leads to open neural tube defects including spina bifida. Using mouse embryos, we show that cell protrusions emanating from the apposed neural fold tips, at the interface between the neuroepithelium and the surface ectoderm, are required for completion of neural tube closure. By genetically ablating the cytoskeletal regulators Rac1 or Cdc42 in the dorsal neuroepithelium, or in the surface ectoderm, we show that these protrusions originate from surface ectodermal cells and that Rac1 is necessary for the formation of membrane ruffles which typify late closure stages, whereas Cdc42 is required for the predominance of filopodia in early neurulation. This study provides evidence for the essential role and molecular regulation of membrane protrusions prior to fusion of a key organ primordium in mammalian development. DOI: http://dx.doi.org/10.7554/eLife.13273.001 PMID:27114066

Perforator flap based on the third perforator of the profunda femoris artery (PFA)-assisted closure of the free vertical posteromedial thigh (vPMT) flap donor site.

PubMed

Scaglioni, Mario F; Barth, Andrè A; Chen, Yen-Chou

2018-06-19

The primary closure of the vertical posteromedial thigh (vPMT) free flap donor site is very important to minimize donor site morbidity and maximize cosmetic appearance. However, sometimes due to the dimension of the defect, a vPMT flap is wider than the 8-10 cm requirement. The authors report their experience with the third perforator of the profunda femoris artery (PFA) during the vPMT free flap donor-site closure. Between January 2016 and December 2017, 5 patients underwent reconstruction of lower extremity (2 pts.) and head and neck (3 pts.) area with the free vPMT flaps. Attempts to close the vPMT free flap donor site directly failed due to the flaps' width (average: 11 cm) and pedicled perforator flaps based on the third perforator of the PFA at the distal thigh were harvested to close the defect primary without the use of a skin graft. The size of perforator flap based on 3rd perforator of PFA was on average 6 cm × 4 cm (ranged: 4-8 cm × 3-6 cm). In all patients, the third perforator of the PFA was identified and the perforator diameter was on average 2.0 mm (range, 1.8-2.2 mm). All perforators were musculocutaneous and single. The dimensions of the flaps were on average 6 cm × 4 cm (range: 4 to 8 cm × 3 to 6 cm). All flaps healed uneventfully without complications and the patients were satisfied with cosmetic and functional results at 6 months follow-up. The third perforator of the PFA may be an option to ensure primary closure of the PMT flap donor site, when a larger flap for reconstruction is needed with subsequent impossibility to achieve primary closure of the donor site. © 2018 Wiley Periodicals, Inc.

Modified Design of Anterolateral Thigh Flap for Total Pharyngolaryngectomy Reconstruction: A Single-Center Experience.

PubMed

Cheng, Li-Yen; Chen, Cha-Chun; Lin, Hwang-Chi; Jeng, Chu-Hsu; Lin, Shang-Hsi; Chen, Wei-Nung Jim; Lin, Yu-Hsien; Hao, Sheng-Po

2018-07-01

Defects after total pharyngolaryngectomy for hypopharyngeal cancer often require reconstruction via free tissue transfer. Recently, anterolateral thigh (ALT) flap has become the gold standard in many centers because of its advantages with respect to versatility, minimal donor-site morbidity, good speech quality, and relatively low fistula and anastomotic leakage rates. Moreover, ALT allows 2 surgical teams to work simultaneously. However, the height of the parallelogram in the ALT design for neoesophagus reconstruction is usually set at a minimum of 9.4 cm (circumference, 2πr) for smooth food passage. Because this height exceeds 8 cm, the donor site may not be closed primarily, which highly depends on the patient's body habitus and the skin tone or quality and requires other methods, such as local flap or skin graft for wound closure, which subsequently increase operating time and donor-site complication rate. Thus, we aimed to construct a simple and modified ALT design that will not only include the advantages described earlier but also provide adequate donor-site primary closure without jeopardizing complication rates. Ten patients with hypopharyngeal cancer underwent reconstructive surgery using our modified ALT design after total pharyngolaryngectomy between 2010 and 2017. Our modified ALT design converts this "classical" shape into a parallelogram so that the height of the modified design is always less than 8 cm, thus allowing for easy primary closure of the wound. The donor-site defects of all 10 patients were closed primarily. No donor-site complications and partial or total flap loss were observed. One patient experienced persistent wound infection with dehiscence, for which debridement was performed. The stricture and fistula rates were 10% (n = 1) and 20% (n = 2), respectively. The mean follow-up time is approximately 1 year. Minimizing donor-site morbidity is an important goal in reconstructive surgery. Our modified ALT flap design is simple, enabling easy primary closure of the donor-site defect, with improved results for the patient and operators. Furthermore, this design is also suitable for ALT flaps with widths larger than 8 cm.

Is the new Occlutech duct occluder an appropriate device for transcatheter closure of patent ductus arteriosus?

PubMed

Godart, François; Houeijeh, Ali; Domanski, Olivia; Guillaume, Marie-Paule; Brard, Mélanie; Lucron, Hugues

2018-06-15

To describe our initial experience with the Occlutech Duct Occluder (ODO) for percutaneous closure of patent ductus arteriosus (PDA). Retrospective review of patients undergoing transcatheter PDA closure with the ODO in 2 academic centers. From April 2013 to September 2017, 42 patients underwent PDA closure. Median age at implantation was 34 months (range 4 months-68 years) and median weight was 12 kg (range 4.1-57 kg). Ducts were Krichenko type A duct (n = 34), type E (n = 6), and type C (n = 2). The mean duct diameter was 3.76 mm (range 1.69 to 9.95 mm, median 3.1 mm). Implantation succeeded in all. There was neither device embolization nor hemolysis. At device release, immediate angiogram showed a small residual shunt in 54.7%. During follow-up, Doppler echocardiography demonstrated 71% of full occlusion at day one, rising to 95% at one month and 100% at one year and half after implantation. The mean maximal systolic pressure gradient in left pulmonary artery was 4.2 ± 4.3 mm and across the distal aortic arch 5.4 ± 4.7 mm Hg. No patient had any significant stenosis with clinical relevance. ODO is safe and effective in transcatheter closure of PDA including relatively large sized ducts. The results are satisfactory with a high level of full occlusion and a low rate of complications. Further evaluation with larger studies and longer follow-up will be required to confirm these preliminary good results. Copyright © 2018. Published by Elsevier B.V.

Modeling of defect-tolerant thin multi-junction solar cells for space application

NASA Astrophysics Data System (ADS)

Mehrotra, A.; Alemu, A.; Freundlich, A.

2012-02-01

Using drift-diffusion model and considering experimental III-V material parameters, AM0 efficiencies of lattice-matched multijunction solar cells have been calculated and the effects of dislocations and radiation damage have been analyzed. Ultrathin multi-junction devices perform better in presence of dislocations or/and radiation harsh environment compared to conventional thick multijunction devices. Our results show that device design optimization of Ga0.51In0.49P/GaAs multijunction devices leads to an improvement in EOL efficiency from 4.8%, for the conventional thick device design, to 12.7%, for the EOL optimized thin devices. In addition, an optimized defect free lattice matched Ga0.51In0.49P/GaAs solar cell under 1016cm-2 1Mev equivalent electron fluence is shown to give an EOL efficiency of 12.7%; while a Ga0.51In0.49P/GaAs solar cell with 108 cm-2 dislocation density under 1016cm-2 electron fluence gives an EOL efficiency of 12.3%. The results suggest that by optimizing the device design, we can obtain nearly the same EOL efficiencies for high dislocation metamorphic solar cells and defect filtered metamorphic multijunction solar cells. The findings relax the need for thick or graded buffer used for defect filtering in metamorphic devices. It is found that device design optimization allows highly dislocated devices to be nearly as efficient as defect free devices for space applications.

21 CFR 878.4011 - Tissue adhesive with adjunct wound closure device for topical approximation of skin.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery...

21 CFR 878.4011 - Tissue adhesive with adjunct wound closure device for topical approximation of skin.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery...

21 CFR 878.4011 - Tissue adhesive with adjunct wound closure device for topical approximation of skin.

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery...

Prevention of internal hernias and pelvic adhesions following laparoscopic left-sided colorectal resection: the role of fibrin sealant.

PubMed

Angelini, Pierluigi; Sciuto, Antonio; Cuccurullo, Diego; Pirozzi, Felice; Reggio, Stefano; Corcione, Francesco

2017-07-01

Laparoscopy has increasingly become the standard of care for patients who undergo colorectal surgery for both benign and malignant diseases. This growing experience has also resulted in more reports of postoperative complications from the minimally invasive approach to primary colorectal resection. Small bowel obstruction from internal hernias and pre-sacral adhesions is an uncommon but not negligible complication. However, there is little literature specific to this topic with recommendations for different methods to prevent it. We report our original technique of closing the mesenteric defect and covering the pre-sacral fascia by using fibrin sealant to prevent this complication. From January 2005 to December 2014, a total of 1079 patients underwent elective laparoscopic left colorectal resection (left hemicolectomy or anterior rectal resection) in our department. In the first 298 procedures, the mesenteric defect was left open, while in the following 781 procedures, it was closed using fibrin sealant with the aim of preventing postoperative small bowel obstruction. Among the first 298 patients, three (1%) required reoperation for small bowel obstruction due to internal hernia (0.33%) or critical pre-sacral adhesions (0.66%). These complications did not occur in the subsequent series in which all 781 patients were treated with fibrin sealant prophylactic closure of the mesenteric defect. In our experience, fibrin sealant closure of the mesenteric defect has demonstrated to be safe and effective in preventing postoperative small bowel obstruction that remains a complication both in open and in laparoscopic colorectal surgeries.

49 CFR 178.338-11 - Discharge control devices.

Code of Federal Regulations, 2011 CFR

2011-10-01

... water capacity, remote means of automatic closure must be installed at the ends of the cargo tank in at... control system. (ii) On a cargo tank motor vehicle of 3,500 gallons water capacity or less, at least one remote means of automatic closure must be installed on the end of the cargo tank farthest away from the...

A Quick Guide to Paravalvular Leak Closure

PubMed Central

Gafoor, Sameer; Franke, Jennifer; Bertog, Stefan; Lam, Simon; Vaskelyte, Laura; Hofmann, Ilona; Matic, Predrag

2015-01-01

Paravalvular leak (PVL) is a seldomly covered aspect of structural heart disease. However, this is a condition that frequently presents after valvular replacement. This article will cover the diagnosising and treating PVL (i.e. imaging, access, and device selection). In addition, specific aspects of aortic and mitral PVL closure will be covered in this review. PMID:29588686

Turbulent fluid motion IV-averages, Reynolds decomposition, and the closure problem

NASA Technical Reports Server (NTRS)

Deissler, Robert G.

1992-01-01

Ensemble, time, and space averages as applied to turbulent quantities are discussed, and pertinent properties of the averages are obtained. Those properties, together with Reynolds decomposition, are used to derive the averaged equations of motion and the one- and two-point moment or correlation equations. The terms in the various equations are interpreted. The closure problem of the averaged equations is discussed, and possible closure schemes are considered. Those schemes usually require an input of supplemental information unless the averaged equations are closed by calculating their terms by a numerical solution of the original unaveraged equations. The law of the wall for velocities and temperatures, the velocity- and temperature-defect laws, and the logarithmic laws for velocities and temperatures are derived. Various notions of randomness and their relation to turbulence are considered in light of ergodic theory.

Cost-Effectiveness of Percutaneous Closure of the Left Atrial Appendage in Atrial Fibrillation Based on Results from PROTECT AF vs. PREVAIL

PubMed Central

Freeman, James V.; Hutton, David W.; Barnes, Geoffrey D.; Zhu, Ruo P.; Owens, Douglas K.; Garber, Alan M.; Go, Alan S.; Hlatky, Mark A.; Heidenreich, Paul A.; Wang, Paul J.; Al-Ahmad, Amin; Turakhia, Mintu P.

2016-01-01

Background Randomized trials of left atrial appendage (LAA) closure with the Watchman device have shown varying results, and its cost-effectiveness compared to anticoagulation has not been evaluated using all available contemporary trial data. Methods and Results We used a Markov decision model to estimate lifetime quality-adjusted survival, costs, and cost-effectiveness of LAA closure with Watchman, compared directly with warfarin and indirectly with dabigatran, using data from the long-term (mean 3.8 year) follow-up of PROTECT AF and PREVAIL randomized trials. Using data from PROTECT AF, the incremental cost-effectiveness ratios (ICER) compared to warfarin and dabigatran were $20,486 and $23,422 per quality adjusted life year (QALY), respectively. Using data from PREVAIL, LAA closure was dominated by warfarin and dabigatran, meaning that it was less effective (8.44, 8.54, and 8.59 QALYs, respectively) and more costly. At a willingness-to-pay-threshold of $50,000 per QALY, LAA closure was cost-effective 90% and 9% of the time under PROTECT AF and PREVAIL assumptions, respectively. These results were sensitive to the rates of ischemic stroke and intracranial hemorrhage for LAA closure and medical anticoagulation. Conclusions Using data from the PROTECT AF trial, LAA closure with the Watchman device was cost-effective; using PREVAIL trial data, Watchman was more costly and less effective than warfarin and dabigatran. PROTECT AF enrolled more patients and has substantially longer follow-up time, allowing greater statistical certainty with the cost-effectiveness results. However, longer term trial results and post-marketing surveillance of major adverse events will be vital to determining the value of the Watchman in clinical practice. PMID:27307517

Endoscopic management of gastrointestinal perforations, leaks and fistulas

PubMed Central

Rogalski, Pawel; Daniluk, Jaroslaw; Baniukiewicz, Andrzej; Wroblewski, Eugeniusz; Dabrowski, Andrzej

2015-01-01

Gastrointestinal perforations, leaks and fistulas may be serious and life-threatening. The increasing number of endoscopic procedures with a high risk of perforation and the increasing incidence of leakage associated with bariatric operations call for a minimally invasive treatment for these complications. The therapeutic approach can vary greatly depending on the size, location, and timing of gastrointestinal wall defect recognition. Some asymptomatic patients can be treated conservatively, while patients with septic symptoms or cardio-pulmonary insufficiency may require intensive care and urgent surgical treatment. However, most gastrointestinal wall defects can be satisfactorily treated by endoscopy. Although the initial endoscopic closure rates of chronic fistulas is very high, the long-term results of these treatments remain a clinical problem. The efficacy of endoscopic therapy depends on several factors and the best mode of treatment will depend on a precise localization of the site, the extent of the leak and the endoscopic appearance of the lesion. Many endoscopic tools for effective closure of gastrointestinal wall defects are currently available. In this review, we summarized the basic principles of the management of acute iatrogenic perforations, as well as of postoperative leaks and chronic fistulas of the gastrointestinal tract. We also described the effectiveness of various endoscopic methods based on current research and our experience. PMID:26457014

Robotics in cardiac surgery: the Istanbul experience.

PubMed

Sagbas, Ertan; Akpinar, Belhhan; Sanisoglu, Ilhan; Caynak, Baris; Guden, Mustafa; Ozbek, Ugur; Bayramoglu, Zehra; Bayindir, Osman

2006-06-01

Robots are sensor-based tools capable of performing precise, accurate and versatile actions. Initially designed to spare humans from risky tasks, robots have progressed into revolutionary tools for surgeons. Tele-operated robots, such as the da Vinci (Intuitive Surgical, Mountain View, CA), have allowed cardiac procedures to start benefiting from robotics as an enhancement to traditional minimally invasive surgery. The aim of this text was to discuss our experience with the da Vinci system during a 12 month period in which 61 cardiac patients were operated on. There were 59 coronary bypass patients (CABG) and two atrial septal defect (ASD) closures. Two patients (3.3%) had to be converted to median sternotomy because of pleural adhesions. There were no procedure- or device-related complications. Our experience suggests that robotics can be integrated into routine cardiac surgical practice. Systematic training, team dedication and proper patient selection are important factors that determine the success of a robotic surgery programme. Copyright 2006 John Wiley & Sons, Ltd.

A Prospective, Randomized, Double-Blind Multicenter Study Comparing Continuous Diffusion of Oxygen Therapy to Sham Therapy in the Treatment of Diabetic Foot Ulcers.

PubMed

Niederauer, Mark Q; Michalek, Joel E; Armstrong, David G

2017-09-01

Over the past generation, preclinical data have suggested that there is a potential physiologic benefit to applying oxygen topically to wounds. However, we are unaware of any studies in the literature that have robustly assessed whether this would lead to a higher proportion of healing in similarly treated people without oxygen. Therefore, the purpose of this study was to assess this in people being treated for chronic diabetic foot ulcers (DFUs). We enrolled and randomized 100 subjects with DFUs (79% male, aged 58.3 ± 12.1 years) to receive either active continuous diffusion of oxygen (CDO) therapy using an active CDO device, or an otherwise fully operational sham device that provided moist wound therapy (MWT) without delivering oxygen. Patients were followed until closure or 12 weeks, whichever was sooner. Patients, treating physicians and independent evaluators were blinded to the study arm. All patients received identical offloading, dressings and follow-up. There were no significant differences in assessed descriptive characteristics between the treatment arms ( P > .05 for all). A significantly higher proportion of people healed in the active arm compared to sham (46% vs 22%, P = .02). This relative effect became greater in more chronic wounds (42.5% vs 13.5%, P = .006). Patients randomized to the active device experienced significantly faster rates of closure relative to the sham ( P < .001). The results of this study suggest that continuously diffused oxygen over a wound leads to significantly higher rates of closure, and faster time to closure, compared to similarly treated patients receiving standard therapy coupled with a sham device. Furthermore, the relative efficacy appears to improve the more the therapy may be needed (more chronic and larger wounds).

Transcatheter closure of patent ductus arteriosus using the AMPLATZER™ duct occluder II (ADO II).

PubMed

Gruenstein, Daniel H; Ebeid, Makram; Radtke, Wolfgang; Moore, Phillip; Holzer, Ralf; Justino, Henri

2017-05-01

The study purpose is to evaluate the safety and efficacy of the ADO II device for closure of patent ductus arteriosus (PDA) in children. Transcatheter treatment of PDA has been evolving for 40+ years and is the treatment of choice. The AMPLATZER™ Duct Occluder (ADO) device was developed for larger diameter ducts and is not ideal in all PDAs. ADO II was developed for small to moderate-sized ducts. This is a single-arm, multicenter study evaluating safety and efficacy of the ADO II device. Patients <18 years were screened for a PDA ≤5.5 mm in diameter and 3-12 mm in length. Right and left heart catheterization was performed, and hemodynamic data were obtained at the time of implant. The diameter of the left pulmonary artery (LPA) and descending aorta, and the presence of any pre-existing pressure gradients across the LPA or aortic arch were assessed at baseline and 6 months post-implant. A total of 192 patients were enrolled. The median implant time was 74 min. Median fluoroscopy time was 12 min. A retrograde (aortic) approach was used in 33% of procedures and demonstrated a statistically significant reduction in fluoroscopy time (P value = 0.0018) compared to an antegrade approach. The device was successfully implanted in 93% of patients, with complete closure in 98% of successful implantations. In this prospective study, the ADO II was safe and effective for closure of small to moderate PDAs. Implantation is simple and the ability for retrograde aortic delivery reduces procedure-related radiation exposure. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Reconstruction of maxillary cemento-ossifying fibroma defect with buccal pad of fat.

PubMed

Sivaraj, Subramonian; Jeevadhas, Pratheep

2013-07-01

A cemento-ossifying fibroma (COF) is a rare benign neoplasm of maxilla when compared with mandible (World Health Organization, 1992). COF of maxilla may be quite large and locally very aggressive lesion. These tumor mass was peeled out by en-bloc excision using gentle blunt dissection. This paper presents 35-year-old male patient who had a gradually expanding lobular mass in the left maxillary posterior region for past 1 year. He has been treated successfully by surgical en-bloc resection. Various techniques were used to reconstruction the defect. Buccal pad of fat is a simple technique having advantages like good vascularity, adaptability, good closure of the defect with favorable prognosis.

Periodic surface structure bifurcation induced by ultrafast laser generated point defect diffusion in GaAs

DOE Office of Scientific and Technical Information (OSTI.GOV)

Abere, Michael J.; Yalisove, Steven M.; Torralva, Ben

2016-04-11

The formation of high spatial frequency laser induced periodic surface structures (HSFL) with period <0.3 λ in GaAs after irradiation with femtosecond laser pulses in air is studied. We have identified a point defect generation mechanism that operates in a specific range of fluences in semiconductors between the band-gap closure and ultrafast-melt thresholds that produces vacancy/interstitial pairs. Stress relaxation, via diffusing defects, forms the 350–400 nm tall and ∼90 nm wide structures through a bifurcation process of lower spatial frequency surface structures. The resulting HSFL are predominately epitaxial single crystals and retain the original GaAs stoichiometry.

Gerbode defect and multivalvular dysfunction: Complex complications in adult congenital heart disease.

PubMed

Ruivo, Catarina; Guardado, Joana; Montenegro Sá, Fernando; Saraiva, Fátima; Antunes, Alexandre; Correia, Joana; Morais, João

2017-07-01

We report a clinical case of a 40-year-old male with surgically corrected congenital heart disease (CHD) 10 years earlier: closure of ostium primum, mitral annuloplasty, and aortic valve and root surgery. The patient was admitted with acute heart failure. Transesophageal echocardiography (TEE) revealed a dysmorphic and severely incompetent aortic valve, a partial tear of the mitral valve cleft repair and annuloplasty ring dehiscence. A true left ventricular-to-right atrial shunt confirmed a direct Gerbode defect. The authors aim to discuss the diagnostic challenge of adult CHD, namely the key role of TEE on septal defects and valve regurgitations description. © 2017, Wiley Periodicals, Inc.

Circulating Matrix Metalloproteinase-2 and -9 Enzyme Activities in the Children with Ventricular Septal Defect

PubMed Central

Cheng, Kun-Shan; Liao, Yan-Chiou; Chen, Mu-Yuan; Kuan, Tang-Ching; Hong, Yi-Han; Ko, Li; Hsieh, Wen-Yeh; Wu, Chien-Liang; Chen, Ming-Ren; Lin, Chih-Sheng

2013-01-01

Ventricular septal defect (VSD) is the most common form of congenital heart diseases. Matrix metalloproteinases (MMPs) are a family of zinc-dependent endopeptidases involved in causal cardiac tissue remodeling. We studied the changes of circulating MMP-2 and MMP-9 activities in the patients with VSD severity and closure. There were 96 children with perimembranous VSD enrolled in this study. We assigned the patients into three groups according to the ratio of VSD diameter/diameter of aortic root (Ao). They were classified as below: Trivial (VSD/Ao ratio ≤ 0.2), Small (0.2 < VSD/Ao ≤ 0.3) and Median (0.3 < VSD/Ao) group. Plasma MMP-2 and MMP-9 activities were assayed by gelatin zymography. There was a significant higher MMP-2 activity in the VSD (Trivial, Small and Median) groups compared with that in Control group. The plasma MMP-9 activity showed a similar trend as the findings in MMP-2 activity. After one year follow-up, a significant difference in the MMP-9 activity was found between VSD spontaneous closure and non-closure groups. In conclusion, a positive trend between the severity of VSD and activities of MMP-2 and MMP-9 was found. Our data imply that MMP-2 and MMP-9 activities may play a role in the pathogenesis of VSD. PMID:23847438

Circulating matrix metalloproteinase-2 and -9 enzyme activities in the children with ventricular septal defect.

PubMed

Cheng, Kun-Shan; Liao, Yan-Chiou; Chen, Mu-Yuan; Kuan, Tang-Ching; Hong, Yi-Han; Ko, Li; Hsieh, Wen-Yeh; Wu, Chien-Liang; Chen, Ming-Ren; Lin, Chih-Sheng

2013-01-01

Ventricular septal defect (VSD) is the most common form of congenital heart diseases. Matrix metalloproteinases (MMPs) are a family of zinc-dependent endopeptidases involved in causal cardiac tissue remodeling. We studied the changes of circulating MMP-2 and MMP-9 activities in the patients with VSD severity and closure. There were 96 children with perimembranous VSD enrolled in this study. We assigned the patients into three groups according to the ratio of VSD diameter/diameter of aortic root (Ao). They were classified as below: Trivial (VSD/Ao ratio ≤ 0.2), Small (0.2 < VSD/Ao ≤ 0.3) and Median (0.3 < VSD/Ao) group. Plasma MMP-2 and MMP-9 activities were assayed by gelatin zymography. There was a significant higher MMP-2 activity in the VSD (Trivial, Small and Median) groups compared with that in Control group. The plasma MMP-9 activity showed a similar trend as the findings in MMP-2 activity. After one year follow-up, a significant difference in the MMP-9 activity was found between VSD spontaneous closure and non-closure groups. In conclusion, a positive trend between the severity of VSD and activities of MMP-2 and MMP-9 was found. Our data imply that MMP-2 and MMP-9 activities may play a role in the pathogenesis of VSD.

78 FR 67365 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

... reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation who... premarket approval application regarding the Boston Scientific WATCHMAN Left Atrial Appendage (LAA) Closure... placed in the left atrial appendage. This device is intended to prevent thrombus embolization from the...

The Impact of Turtle Excluder Devices and Fisheries Closures on Loggerhead and Kemp's Ridley Strandings in the Western Gulf of Mexico

USGS Publications Warehouse

Lewison, R.L.; Crowder, L.B.; Shaver, D.J.

2003-01-01

The Sea Turtle Stranding and Salvage Network has been monitoring turtle strandings for more than 20 years in the United States. High numbers of strandings in the early to mid-1980s prompted regulations to require turtle excluder devices (TEDs) on shrimping vessels (trawlers). Following year-round TED implementation in 1991, however, stranding levels in the Gulf of Mexico increased. We evaluated the efficacy of TEDs and other management actions (e.g., fisheries closures) on loggerhead (Caretta caretta) and Kemp's ridley (Lepidochelys kempii) turtle populations by analyzing a long-term, stranding data set from the western Gulf of Mexico. Our analyses suggest that both sea turtle population growth and shrimping activity have contributed to the observed increase in strandings. Compliance with regulations requiring turtle excluder devices was a significant factor in accounting for annual stranding variability: low compliance was correlated with high levels of strandings. Our projections suggest that improved compliance with TED regulations will reduce strandings to levels that, in conjunction with other protective measures, should promote population recoveries for loggerhead and Kemp's ridley turtles. Local, seasonal fisheries closures, concurrent with TED enforcement, could reduce strandings to even lower levels. A seasonal closure adjacent to a recently established Kemp's ridley nesting beach may also reduce mortality of nesting adults and thus promote long-term population persistence by fostering the establishment of a robust secondary nesting site.

Hybrid approach to surgical correction of tetralogy of Fallot in all patients with functioning Blalock Taussig shunts.

PubMed

Sivakumar, Kothandam; Krishnan, Prasad; Pieris, Rajeeva; Francis, Edwin

2007-08-01

In total surgical correction of tetralogy of Fallot (TOF) with functioning Blalock Taussig shunts (BTS), shunt take down increased surgical time, bleeding, and might injure phrenic and recurrent laryngeal nerve and thoracic duct. A routine hybrid approach using transcatheter BTS closure immediately before total surgical correction of TOF in all patients might reduce these problems. We analyze the safety and feasibility of this approach. Transcatheter BTS closure was achieved using single or multiple stainless steel embolization coils, Amplatzer vascular plugs, or duct occluders. When coils were released without control by bioptome forceps, coil migration in larger shunts was prevented by proximal or distal balloon occlusion. This routine hybrid strategy was followed in 22 consecutive patients aged 1-13 years over 4-year-period and 21 procedures were successful. Among the 16 patients attempted with coils, 13 had successful closure, 2 needed Amplatzer duct occluder devices, and 1 sent for surgical shunt takedown due to acute angulation of the shunt. New Amplatzer vascular plugs were used in six patients. Bioptome was used in six patients and proximal or distal balloon occlusion of flow was used in three patients. Four patients had closure of associated aortopulmonary or chest wall collaterals. Hybrid approach using routine transcatheter closure of all BTS immediately before surgical correction of TOF shunts with coils/plugs/devices is safe, feasible, and reproducible. Copyright (c) 2007 Wiley-Liss, Inc.

Quantitative Observation of Threshold Defect Behavior in Memristive Devices with Operando X-ray Microscopy.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Liu, Huajun; Dong, Yongqi; Cherukara, Matthew J.

Memristive devices are an emerging technology that enables both rich interdisciplinary science and novel device functionalities, such as nonvolatile memories and nanoionics-based synaptic electronics. Recent work has shown that the reproducibility and variability of the devices depend sensitively on the defect structures created during electroforming as well as their continued evolution under dynamic electric fields. However, a fundamental principle guiding the material design of defect structures is still lacking due to the difficulty in understanding dynamic defect behavior under different resistance states. Here, we unravel the existence of threshold behavior by studying model, single-crystal devices: resistive switching requires that themore » pristine oxygen vacancy concentration reside near a critical value. Theoretical calculations show that the threshold oxygen vacancy concentration lies at the boundary for both electronic and atomic phase transitions. Through operando, multimodal X-ray imaging, we show that field tuning of the local oxygen vacancy concentration below or above the threshold value is responsible for switching between different electrical states. These results provide a general strategy for designing functional defect structures around threshold concentrations to create dynamic, field-controlled phases for memristive devices.« less

Transcatheter closure of moderate-to-large patent ductus arteriosus in infants using Amplatzer duct occluder.

PubMed

Wang, Jou-Kou; Wu, Mei-Hwan; Lin, Ming-Tai; Chiu, Shuenn-Nan; Chen, Chun-An; Chiu, Hsin-Hui

2010-02-01

There are difficulties in transcatheter closure of patent ductus arteriosus (PDA) in infants. The 46 infants (mean age 6.2+/-2.7 months; mean body weight 6.3+/-1.6 kg) who underwent PDA closure using the Amplatzer duct occluder (ADO). The indication for using an ADO was a ductus diameter > or =2.5 or 3 mm. Device diameter selected was 1-3 mm larger than ductal diameter. The mean systolic pulmonary artery pressure was 40.9+/-18.2 mmHg. The mean Qp/Qs ratio was 3.1+/-1.2. The mean ductus diameter was 3.3+/-0.8 mm. ADO was successfully deployed in 45 patients. Failure occurred in 1 case. The mean diameter of device used was 5.4+/-1.1 mm. No severe complications occurred. At the 1-month echocardiographic follow-up, a small residual shunt was present in 4 of 45 patients and had disappeared in all 4 patients at the 3-month follow-up. One patient developed a moderate degree of left ventricular outflow tract obstruction 2.3 years after the procedure. Transcatheter closure of PDA in infants using the ADO is a safe and effective method.

Probabilistic distributions of pinhole defects in atomic layer deposited films on polymeric substrates

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yersak, Alexander S., E-mail: alexander.yersak@colorado.edu; Lee, Yung-Cheng

Pinhole defects in atomic layer deposition (ALD) coatings were measured in an area of 30 cm{sup 2} in an ALD reactor, and these defects were represented by a probabilistic cluster model instead of a single defect density value with number of defects over area. With the probabilistic cluster model, the pinhole defects were simulated over a manufacturing scale surface area of ∼1 m{sup 2}. Large-area pinhole defect simulations were used to develop an improved and enhanced design method for ALD-based devices. A flexible thermal ground plane (FTGP) device requiring ALD hermetic coatings was used as an example. Using a single defectmore » density value, it was determined that for an application with operation temperatures higher than 60 °C, the FTGP device would not be possible. The new probabilistic cluster model shows that up to 40.3% of the FTGP would be acceptable. With this new approach the manufacturing yield of ALD-enabled or other thin film based devices with different design configurations can be determined. It is important to guide process optimization and control and design for manufacturability.« less

Nonwoven-Based Gelatin/Polycaprolactone Membrane Proves Suitability in a Preclinical Assessment for Treatment of Soft Tissue Defects

PubMed Central

Schulz, Simon; Angarano, Marco; Fabritius, Martin; Mülhaupt, Rolf; Dard, Michel; Obrecht, Marcel; Tomakidi, Pascal

2014-01-01

Standard preclinical assessments in vitro often have limitations regarding their transferability to human beings, mainly evoked by their nonhuman and tissue-different/nontissue-specific source. Here, we aimed at employing tissue-authentic simple and complex interactive fibroblast-epithelial cell systems and their in vivo-relevant biomarkers for preclinical in vitro assessment of nonwoven-based gelatin/polycaprolactone membranes (NBMs) for treatment of soft tissue defects. NBMs were composed of electrospun gelatin and polycaprolactone nanofiber nonwovens. Scanning electron microscopy in conjunction with actin/focal contact integrin fluorescence revealed successful adhesion and proper morphogenesis of keratinocytes and fibroblasts, along with cells' derived extracellular matrix deposits. The “feel-good factor” of cells under study on the NBM was substantiated by forming a confluent connective tissue entity, which was concomitant with a stratified epithelial equivalent. Immunohistochemistry proved tissue authenticity over time by abundance of the biomarker vimentin in the connective tissue entity, and chronological increase of keratins KRT1/10 and involucrin expression in epithelial equivalents. Suitability of the novel NBM as wound dressing was evidenced by an almost completion of epithelial wound closure in a pilot mini-pig study, after a surgical intervention-caused gingival dehiscence. In summary, preclinical assessment by tissue-authentic cell systems and the animal pilot study revealed the NBM as an encouraging therapeutic medical device for prospective clinical applications. PMID:24494668

The influence of interfacial defects on fast charge trapping in nanocrystalline oxide-semiconductor thin film transistors

NASA Astrophysics Data System (ADS)

Kim, Taeho; Hur, Jihyun; Jeon, Sanghun

2016-05-01

Defects in oxide semiconductors not only influence the initial device performance but also affect device reliability. The front channel is the major carrier transport region during the transistor turn-on stage, therefore an understanding of defects located in the vicinity of the interface is very important. In this study, we investigated the dynamics of charge transport in a nanocrystalline hafnium-indium-zinc-oxide thin-film transistor (TFT) by short pulse I-V, transient current and 1/f noise measurement methods. We found that the fast charging behavior of the tested device stems from defects located in both the front channel and the interface, following a multi-trapping mechanism. We found that a silicon-nitride stacked hafnium-indium-zinc-oxide TFT is vulnerable to interfacial charge trapping compared with silicon-oxide counterpart, causing significant mobility degradation and threshold voltage instability. The 1/f noise measurement data indicate that the carrier transport in a silicon-nitride stacked TFT device is governed by trapping/de-trapping processes via defects in the interface, while the silicon-oxide device follows the mobility fluctuation model.

Pelvic flexure enterotomy closure in the horse with a TA-90 stapling device: A retrospective clinical study of 84 cases (2001–2008)

PubMed Central

Rosser, Julie; Brounts, Sabrina; Slone, Don; Lynch, Tim; Livesey, Michael; Hughes, Faith; Clark, Carol

2012-01-01

Our objective was to compare survival and complication rates of horses undergoing pelvic flexure enterotomy closure with a TA-90 stapler to those with hand-sewn closure. Medical records of horses undergoing pelvic flexure enterotomy between 2001 and 2008 were reviewed. History, clinical signs, surgical findings, surgical techniques, and post-operative complications were recorded. Long-term outcome was established by telephone questionnaire. Of 84 pelvic flexure enterotomies performed, 70 were stapled and 14 were hand-sewn. Seventy-seven horses survived to discharge (91.7%). There were no significant associations between survival and closure technique (P = 0.69). Follow-up was available for 54 horses; 50 survived long-term (93.0%). No statistical significance was identified between long-term survival and closure method (P = 0.39). Forty horses went on to athletic performance (80.0%). TA-90 stapled closure of pelvic flexure enterotomies is a safe technique resulting in survival and complication rates equivalent to those of hand-sewn closure. PMID:23204584

Repair of tetralogy of Fallot associated with atrioventricular septal defect.

PubMed

Tláskal, T; Hucín, B; Kostelka, M; Chaloupecký, V; Marek, J; Tax, P; Janouàek, J; Kuèera, V; Hruda, J; Reich, O; Skovránek, J

1998-01-01

Tetralogy of Fallot, when associated with atrioventricular septal defect permitting shunting at ventricular level, represents a complex cyanotic congenital malformation. Experience with surgical repair is limited, and results vary considerably. Between 1984 and 1996, we repaired 14 consecutive patients with this combination seen in our center. Their ages ranged from 8 months to 21 years (median 7.4 years). Six (42.9%) had Down's syndrome. In eight patients the correct diagnosis was made using echocardiography alone. In the remaining six patients, who had previously-constructed arterial shunts and/or suspected pulmonary arterial stenosis, catheterization and angiocardiography were also performed. The repair consisted of double patch closure of the septal defect, reconstruction of two atrioventricular orifices, and relief of pulmonary stenosis at all levels. In five patients with a hypoplastic pulmonary trunk, a monocusp transannular patch (four patients) or an allograft (one patient) was used for restoration of continuity from the right ventricle to the pulmonary arteries. Patch enlargement of one or both pulmonary arteries was necessary in five patients. One patient (7.1%) died early, and another late. The twelve surviving (85.8%) patients have been followed for 1.2-12.5 years after surgery (median 4.9 years, mean 5.9+/-3.9 years). During the follow-up, reoperation was necessary for repair of residual ventricular septal defect and pulmonary regurgitation in two patients, and closure of an atrial septal defect and alteration to left atrioventricular valvar regurgitation in one patient. Seven patients are in class I of the New York Heart Association, four in class II, and one in class III. Tetralogy of Fallot associated with atrioventricular septal defect can be corrected with low mortality and good long-term results. Residual lesions, however, have a tendency to progress, especially when seen in combination. After surgery, all patients need long-term close follow-up.

Reconstruction of palatal defect using mucoperiosteal hinge flap and pushback palatoplasty.

PubMed

Lee, S I; Lee, H S; Hwang, K

2001-11-01

This article describes a simple, new surgical technique to provide a complete two-layer closure of palatal defect resulting from a surgical complication of trans palatal resection of skull base chordoma. The nasal layer was reconstructed with triangular shape oral mucoperiosteal turn over hinge flap based on anterior margin of palatal defect and rectangular shaped lateral nasal mucosal hinge flaps. The oral layer was reconstructed with conventional pushback V-Y advancement 2-flaps palatoplasty. Each layer of the flaps were secured with two key mattress suture for flap coaptation. This technique has some advantages: simple, short operation time, one-stage procedure, no need of osteotomy. It can close small- to medium-sized palatal defect of palate or wide cleft palate and can prevent common complication of oronasal fistula, which could be caused by tension.

49 CFR 215.125 - Defective uncoupling device.

Code of Federal Regulations, 2014 CFR

2014-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.125 Defective uncoupling device. A railroad may not place or continue in service a car, if the car has an uncoupling device without sufficient vertical and lateral clearance to prevent— (a...

49 CFR 215.125 - Defective uncoupling device.

Code of Federal Regulations, 2011 CFR

2011-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.125 Defective uncoupling device. A railroad may not place or continue in service a car, if the car has an uncoupling device without sufficient vertical and lateral clearance to prevent— (a...

49 CFR 215.125 - Defective uncoupling device.

Code of Federal Regulations, 2010 CFR

2010-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.125 Defective uncoupling device. A railroad may not place or continue in service a car, if the car has an uncoupling device without sufficient vertical and lateral clearance to prevent— (a...

49 CFR 215.125 - Defective uncoupling device.

Code of Federal Regulations, 2013 CFR

2013-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.125 Defective uncoupling device. A railroad may not place or continue in service a car, if the car has an uncoupling device without sufficient vertical and lateral clearance to prevent— (a...

49 CFR 215.125 - Defective uncoupling device.

Code of Federal Regulations, 2012 CFR

2012-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS Freight Car Components Draft System § 215.125 Defective uncoupling device. A railroad may not place or continue in service a car, if the car has an uncoupling device without sufficient vertical and lateral clearance to prevent— (a...

Left atrial appendage closure followed by 6 weeks of antithrombotic therapy: a prospective single-center experience.

PubMed

Chun, K R Julian; Bordignon, Stefano; Urban, Verena; Perrotta, Laura; Dugo, Daniela; Fürnkranz, Alexander; Nowak, Bernd; Schmidt, Boris

2013-12-01

Currently, 2 different left atrial appendage (LAA) closure systems are available for stroke prevention in nonvalvular atrial fibrillation but comparative data are lacking. To prospectively compare procedural data and patient outcome for 2 contemporary LAA closure systems and to investigate an alternative antithrombotic treatment regimen in high-risk patients. Patients with nonvalvular atrial fibrillation, with high risk for stroke, and who either had contraindication or were not willing to accept oral anticoagulation were prospectively enrolled. Watchman (Boston Scientific, Natick, MA; group A) or Amplatzer Cardiac Plug (St Jude Medical, Minneapolis, MN; group B) devices were implanted. All patients received antithrombotic therapy for 6 weeks. After repeat transesophageal echocardiography, patients were switched to aspirin. Eighty patients were enrolled. There was no statistical difference in patient characteristics in groups A and B: CHA2DS2VASC score: 4.1 ± 1.5 versus 4.5 ± 1.8; HASBLED score: 3.1 ± 1.1 versus 3.1 ± 1.1, respectively. LAA closure was achieved in 78 of 80 patients (98%) (group A: 38 of 40 [95%] vs group B: 40 of 40 [100%]). There was no difference in procedure time (group A: 48 ± 16 minutes vs group B: 47 ± 15 minutes; P = .69) and fluoroscopy time (group A: 6.0 ± 4.7 minutes vs group B: 7.3 ± 4.4 minutes; P = .25). Major complications included 1 air embolism and delayed tamponade in each group. After 6 weeks, 1 device dislodgment and 4 device-related thrombi were detected. Ninety-four percent of the patients (73 of 77) were switched to aspirin after 6 weeks. During a median follow-up of 364 days (Q1-Q3: 283-539 days), no systemic embolism occurred, but 3 patients died (heart failure: n = 2; bleeding: n = 1). Implantation of both LAA closure devices can be performed with high success rates in high-risk patients. Postprocedural 6 weeks antithrombotic therapy followed by aspirin therapy needs to be confirmed in a larger study. Copyright © 2013 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Frequency Control of Single Quantum Emitters in Integrated Photonic Circuits

NASA Astrophysics Data System (ADS)

Schmidgall, Emma R.; Chakravarthi, Srivatsa; Gould, Michael; Christen, Ian R.; Hestroffer, Karine; Hatami, Fariba; Fu, Kai-Mei C.

2018-02-01

Generating entangled graph states of qubits requires high entanglement rates, with efficient detection of multiple indistinguishable photons from separate qubits. Integrating defect-based qubits into photonic devices results in an enhanced photon collection efficiency, however, typically at the cost of a reduced defect emission energy homogeneity. Here, we demonstrate that the reduction in defect homogeneity in an integrated device can be partially offset by electric field tuning. Using photonic device-coupled implanted nitrogen vacancy (NV) centers in a GaP-on-diamond platform, we demonstrate large field-dependent tuning ranges and partial stabilization of defect emission energies. These results address some of the challenges of chip-scale entanglement generation.

Frequency Control of Single Quantum Emitters in Integrated Photonic Circuits.

PubMed

Schmidgall, Emma R; Chakravarthi, Srivatsa; Gould, Michael; Christen, Ian R; Hestroffer, Karine; Hatami, Fariba; Fu, Kai-Mei C

2018-02-14

Generating entangled graph states of qubits requires high entanglement rates with efficient detection of multiple indistinguishable photons from separate qubits. Integrating defect-based qubits into photonic devices results in an enhanced photon collection efficiency, however, typically at the cost of a reduced defect emission energy homogeneity. Here, we demonstrate that the reduction in defect homogeneity in an integrated device can be partially offset by electric field tuning. Using photonic device-coupled implanted nitrogen vacancy (NV) centers in a GaP-on-diamond platform, we demonstrate large field-dependent tuning ranges and partial stabilization of defect emission energies. These results address some of the challenges of chip-scale entanglement generation.

Effect of Resorbable Collagen Plug on Bone Regeneration in Rat Critical-Size Defect Model.

PubMed

Liu, Weiqing; Kang, Ning; Dong, Yuliang; Guo, Yuchen; Zhao, Dan; Zhang, Shiwen; Zhou, Liyan; Seriwatanachai, Dutmanee; Liang, Xing; Yuan, Quan

2016-04-01

The purpose of this investigation was to examine the effect of resorbable collagen plug (RCP) on bone regeneration in rat calvarial critical-size defects. About 5-mm-diameter calvarial defects were created in forty 12-week-old male Sprague-Dawley rats and implanted with or without RCP. Animals were killed at 1, 2, 4, and 8 weeks postoperatively. After being killed, specimens were collected and subjected to micro-computed tomography (μCT) and histological analysis. The μCT showed a significant increase of newly formed bone volume/tissue volume in RCP-implanted defect compared with controls at all designated time points. After 8 weeks, the defects implanted with RCP displayed almost complete closure. Hematoxylin and eosin staining of the decalcified sections confirmed these observations and evidenced active bone regeneration in the RCP group. In addition, Masson's trichrome staining demonstrated that RCP implantation accelerated the process of collagen maturation. The RCP enhances bone regeneration in rat critical-size cranial defects, which suggest it might be a desired material for bone defect repair.

Skull Base Cerebrospinal Fluid Leakage Control with a Fibrin-Based Composite Tissue Adhesive

PubMed Central

Rock, Jack P.; Sierra, David H.; Castro-Moure, Frederico; Jiang, Feng

1996-01-01

Cerebrospinal fluid (CSF) leaks can be responsible for significant patient morbidity and mortality. While the majority of leaks induced after head trauma will seal without intervention, spontaneous or surgically-induced leaks often require operative repair. Many modifications on standard surgical technique are available for repair of CSF fistulae, but none assures adequate closure. We have studied the efficacy of a novel fibrin-based composite tissue adhesive (CTA) for closure of experimentally-induced CSF leaks in rats. Fistulae were created in two groups of animals. Two weeks after creation of the leaks, the animals were sacrificed and analyzed for persistence of leak. A 58% leakage rate was noted in the control group (n = 12), and no leaks were noted in the experimental group closed after application of CTA to the surgical defect followed by skin closure (n = 11). Comparing the control group to the experimental group, results were statistically significant (p = 0.015). These data suggest that CTA may be effective as an adjunct for the closure of CSF fistulae. ImagesFigure 2Figure 3 PMID:17170969

Notch signal reception is required in vascular smooth muscle cells for ductus arteriosus closure

PubMed Central

Krebs, Luke T.; Norton, Christine R.; Gridley, Thomas

2017-01-01

Summary The ductus arteriosus is an arterial vessel that shunts blood flow away from the lungs during fetal life, but normally occludes after birth to establish the adult circulation pattern. Failure of the ductus arteriosus to close after birth is termed patent ductus arteriosus, and is one of the most common congenital heart defects. Our previous work demonstrated that vascular smooth muscle cell expression of the Jag1 gene, which encodes a ligand for Notch family receptors, is essential for postnatal closure of the ductus arteriosus in mice. However, it was not known what cell population was responsible for receiving the Jag1-mediated signal. Here we show, using smooth muscle cell-specific deletion of the Rbpj gene, which encodes a transcription factor that mediates all canonical Notch signaling, that Notch signal reception in the vascular smooth muscle cell compartment is required for ductus arteriosus closure. These data indicate that homotypic vascular smooth muscle cell interactions are required for proper contractile smooth muscle cell differentiation and postnatal closure of the ductus arteriosus in mice. PMID:26742650

To Close or Not to Close: The Very Small Patent Ductus Arteriosus

PubMed Central

Fortescue, Elizabeth B.; Lock, James E.; Galvin, Teresa; McElhinney, Doff B.

2014-01-01

Patent ductus arteriosus (PDA) accounts for approximately 10% of all congenital heart diseases, with an incidence of at least 2–4 per 1000 term births. Closure of the large, hemodynamically significant PDA is established as the standard of care, and can be performed safely and effectively using either surgical or transcatheter methods. The appropriate management of the very small, hemodynamically insignificant PDA is less clear. Routine closure of such defects has been advocated to eliminate or reduce the risk of infective endocarditis (IE). However, the risk of IE in patients with a small PDA appears to be extremely low, and IE is treatable. Although closure of the small PDA is generally safe and technically successful, it is unknown whether this treatment truly improves the risk : benefit balance compared with observation. In this article, we review the published literature on the natural history and treatment outcomes in individuals with a PDA, the epidemiology and outcomes of IE, particularly in association with PDA, and the rationale and evidence for closure of the very small PDA. PMID:20653702

Catheter Ablation of Atrial Fibrillation in Patients with Hardware in the Heart - Septal Closure Devices, Mechanical Valves and More.

PubMed

Bartoletti, Stefano; Santangeli, Pasquale; DI Biase, Luigi; Natale, Andrea

2013-01-01

Patients with mechanical "hardware" in the heart, such as those with mechanical cardiac valves or atrial septal closure devices, represent a population at high risk of developing AF. Catheter ablation of AF in these subjects might represent a challenge, due to the perceived higher risk of complications associated with the presence of intracardiac mechanical devices. Accordingly, such patients were excluded or poorly represented in major trials proving the benefit of catheter ablation for the rhythm-control of AF. However, recent evidence supports the concept that catheter ablation procedures might be equally effective in these patients, without a significant increase in the risk of procedural complications. This review will summarize the current state-of-the-art on catheter ablation of AF in patients with mechanical "hardware" in the heart.

Observation of a periodic array of flux-closure quadrants in strained ferroelectric PbTiO 3 films

DOE PAGES

Tang, Y. L.; Zhu, Y. L; Ma, Xiuliang; ...

2015-05-01

Nanoscale ferroelectrics are expected to exhibit various exotic domain configurations, such as the full flux-closure pattern that is well known in ferromagnetic materials. Here we observe not only the atomic morphology of the flux-closure quadrant but also a periodic array of flux closures in ferroelectric PbTiO 3 films, mediated by tensile strain on a GdScO 3 substrate. Using aberration-corrected scanning transmission electron microscopy, we directly visualize an alternating array of clockwise and counterclockwise flux closures, whose periodicity depends on the PbTiO 3 film thickness. In the vicinity of the core, the strain is sufficient to rupture the lattice, with strainmore » gradients up to 10 9 per meter. We found engineering strain at the nanoscale may facilitate the development of nanoscale ferroelectric devices.« less

Transcatheter closure of a large patent ductus arteriosus using jugular access in an infant.

PubMed

Fernandes, Precylia; Assaidi, Anass; Baruteau, Alban-Elouen; Fraisse, Alain

2018-03-01

Trans-catheter device closure of patent ductus arteriosus (PDA) via femoral route is the commonly used, safe and effective procedure. Trans-jugular approach has been successfully used in older children with interrupted inferior vena cava. We report a case of successful occlusion of PDA using Amplatzer duct occluder (ADO) via trans-jugular approach following difficulties encountered in gaining femoral venous access. A 6-month-old male infant, weighing 8 kg was admitted for percutaneous catheter closure of PDA. Echocardiogram showed a 4.5 mm duct and left heart dilatation. Femoral venous access was not possible; therefore, we decided to use a trans-jugular approach. The duct was occluded using 8/6 mm ADO. Successful closure of the duct was confirmed with an aortogram. Post procedure echocardiogram showed no residual shunt across the duct. We highlight that trans-catheter closure of PDA using jugular venous access is safe and effective even in infants.

Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke.

PubMed

Søndergaard, Lars; Kasner, Scott E; Rhodes, John F; Andersen, Grethe; Iversen, Helle K; Nielsen-Kudsk, Jens E; Settergren, Magnus; Sjöstrand, Christina; Roine, Risto O; Hildick-Smith, David; Spence, J David; Thomassen, Lars

2017-09-14

The efficacy of closure of a patent foramen ovale (PFO) in the prevention of recurrent stroke after cryptogenic stroke is uncertain. We investigated the effect of PFO closure combined with antiplatelet therapy versus antiplatelet therapy alone on the risks of recurrent stroke and new brain infarctions. In this multinational trial involving patients with a PFO who had had a cryptogenic stroke, we randomly assigned patients, in a 2:1 ratio, to undergo PFO closure plus antiplatelet therapy (PFO closure group) or to receive antiplatelet therapy alone (antiplatelet-only group). Imaging of the brain was performed at the baseline screening and at 24 months. The coprimary end points were freedom from clinical evidence of ischemic stroke (reported here as the percentage of patients who had a recurrence of stroke) through at least 24 months after randomization and the 24-month incidence of new brain infarction, which was a composite of clinical ischemic stroke or silent brain infarction detected on imaging. We enrolled 664 patients (mean age, 45.2 years), of whom 81% had moderate or large interatrial shunts. During a median follow-up of 3.2 years, clinical ischemic stroke occurred in 6 of 441 patients (1.4%) in the PFO closure group and in 12 of 223 patients (5.4%) in the antiplatelet-only group (hazard ratio, 0.23; 95% confidence interval [CI], 0.09 to 0.62; P=0.002). The incidence of new brain infarctions was significantly lower in the PFO closure group than in the antiplatelet-only group (22 patients [5.7%] vs. 20 patients [11.3%]; relative risk, 0.51; 95% CI, 0.29 to 0.91; P=0.04), but the incidence of silent brain infarction did not differ significantly between the study groups (P=0.97). Serious adverse events occurred in 23.1% of the patients in the PFO closure group and in 27.8% of the patients in the antiplatelet-only group (P=0.22). Serious device-related adverse events occurred in 6 patients (1.4%) in the PFO closure group, and atrial fibrillation occurred in 29 patients (6.6%) after PFO closure. Among patients with a PFO who had had a cryptogenic stroke, the risk of subsequent ischemic stroke was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone; however, PFO closure was associated with higher rates of device complications and atrial fibrillation. (Funded by W.L. Gore and Associates; Gore REDUCE ClinicalTrials.gov number, NCT00738894 .).

Closure of patent foramen ovale versus medical therapy after cryptogenic stroke.

PubMed

Carroll, John D; Saver, Jeffrey L; Thaler, David E; Smalling, Richard W; Berry, Scott; MacDonald, Lee A; Marks, David S; Tirschwell, David L

2013-03-21

Whether closure of a patent foramen ovale is effective in the prevention of recurrent ischemic stroke in patients who have had a cryptogenic stroke is unknown. We conducted a trial to evaluate whether closure is superior to medical therapy alone in preventing recurrent ischemic stroke or early death in patients 18 to 60 years of age. In this prospective, multicenter, randomized, event-driven trial, we randomly assigned patients, in a 1:1 ratio, to medical therapy alone or closure of the patent foramen ovale. The primary results of the trial were analyzed when the target of 25 primary end-point events had been observed and adjudicated. We enrolled 980 patients (mean age, 45.9 years) at 69 sites. The medical-therapy group received one or more antiplatelet medications (74.8%) or warfarin (25.2%). Treatment exposure between the two groups was unequal (1375 patient-years in the closure group vs. 1184 patient-years in the medical-therapy group, P=0.009) owing to a higher dropout rate in the medical-therapy group. In the intention-to-treat cohort, 9 patients in the closure group and 16 in the medical-therapy group had a recurrence of stroke (hazard ratio with closure, 0.49; 95% confidence interval [CI], 0.22 to 1.11; P=0.08). The between-group difference in the rate of recurrent stroke was significant in the prespecified per-protocol cohort (6 events in the closure group vs. 14 events in the medical-therapy group; hazard ratio, 0.37; 95% CI, 0.14 to 0.96; P=0.03) and in the as-treated cohort (5 events vs. 16 events; hazard ratio, 0.27; 95% CI, 0.10 to 0.75; P=0.007). Serious adverse events occurred in 23.0% of the patients in the closure group and in 21.6% in the medical-therapy group (P=0.65). Procedure-related or device-related serious adverse events occurred in 21 of 499 patients in the closure group (4.2%), but the rate of atrial fibrillation or device thrombus was not increased. In the primary intention-to-treat analysis, there was no significant benefit associated with closure of a patent foramen ovale in adults who had had a cryptogenic ischemic stroke. However, closure was superior to medical therapy alone in the prespecified per-protocol and as-treated analyses, with a low rate of associated risks. (Funded by St. Jude Medical; RESPECT ClinicalTrials.gov number, NCT00465270.).

Transcatheter Closure of Patent Ductus Arteriosus in Extremely Premature Newborns: Early Results and Midterm Follow-Up.

PubMed

Zahn, Evan M; Peck, Daniel; Phillips, Alistair; Nevin, Phillip; Basaker, Kaylan; Simmons, Charles; McRae, Marion E; Early, Tracy; Garg, Ruchira

2016-12-12

The goal of this study was to describe early and midterm outcomes of extremely premature newborns (EPNs) who underwent transcatheter echocardiographically guided patent ductus arteriosus (PDA) closure. Surgical ligation of PDA in EPNs confers significant risk for procedural morbidity and adverse long-term outcomes. The Amplatzer Vascular Plug II was used in all cases. Post-ligation syndrome was defined using previously published parameters. Patients were followed at pre-specified intervals, and prospectively collected data were reviewed. Transcatheter closure was attempted in 24 EPNs (mean procedural age 30 days [range 5 to 80 days], mean procedural weight 1,249 g [range 755 to 2,380 g]) and was successful in 88%. The 3 procedural failures were related to the development of left pulmonary artery (LPA) stenosis caused by the device, and all devices were removed uneventfully. Complications included 2 instances of device malposition, resolved with device repositioning, and 1 instance of LPA stenosis, requiring an LPA stent. There were no procedural deaths, cases of post-ligation syndrome, residual PDA, or device embolization. Survival to discharge was 96% (23 of 24), with a single late death unrelated to the procedure. After a median follow-up period of 11.1 months, all patients were alive and well, with no residual PDA or evidence of LPA or aortic coarctation. This newly described technique can be performed safely with a high success rate and minimal procedural morbidity in EPNs. Early and midterm follow-up is encouraging. Future efforts should be directed toward developing specific devices for this unique application. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Closure of the Radial Forearm Free Flap Donor Site Using the Combined Local Triangular Full-Thickness Skin Graft.

PubMed

Moreno-Sánchez, Manuel; González-García, Raúl; Ruiz-Laza, Luis; Manzano Solo de Zaldívar, Damián; Moreno-García, Carlos; Monje, Florencio

2016-01-01

Traditional donor-site closure has been associated with serious esthetic and functional morbidity. The purpose of this study was to assess morbidity in esthetics and function and measure the postoperative complications of the radial forearm free flap (RFFF) donor site after using combined local triangular full-thickness skin grafting. This prospective study of patients who underwent reconstruction of head and neck defects using an RFFF was conducted from July 2008 through December 2014. The donor site was repaired with a combined local triangular full-thickness skin graft. Quality of the scar, color match, tendon exposure, presence of necrosis, dehiscence of the suture, and presence of dysesthesia were recorded and analyzed using SPSS 21.0 software. One hundred consecutive patients (71 male and 29 female) underwent RFFF harvesting. RFFF donor-site defects ranged from 15 to 70 cm2; partial skin graft loss occurred in 7% of patients. Five patients (5%) had small dehiscences of the forearm skin graft, and 2 cases (2%) presented tendon exposure. In all cases, these sites healed secondarily by conservative management, with no final impairment of function. Esthetic results were considered excellent in 87%, good in 11%, and suboptimal in 2% of the cases. The combined local triangular full-thickness skin graft is a reliable method for closing RFFF donor-site defects because it obviates a second surgical site, it provides excellent color match and pliability, and it can be used for covering large defects of the donor site. Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Photomask quality assessment solution for 90-nm technology node

NASA Astrophysics Data System (ADS)

Ohira, Katsumi; Chung, Dong Hoon P.; Nobuyuki, Yoshioka; Tateno, Motonari; Matsumura, Kenichi; Chen, Jiunn-Hung; Luk-Pat, Gerard T.; Fukui, Norio; Tanaka, Yoshio

2004-08-01

As 90 nm LSI devices are about to enter pre-production, the cost and turn-around time of photomasks for such devices will be key factors for success in device production. Such devices will be manufactured with state-of-the-art 193nm photolithography systems. Photomasks for these devices are being produced with the most advanced equipment, material and processing technologies and yet, quality assurance still remains an issue for volume production. These issues include defect classification and disposition due to the insufficient resolution of the defect inspection system at conventional review and classification processes and to aggressive RETs, uncertainty of the impact the defects have on the printed feature as well as inconsistencies of classical defect specifications as applied in the sub-wavelength era are becoming a serious problem. Simulation-based photomask qualification using the Virtual Stepper System is widely accepted today as a reliable mask quality assessment tool of mask defects for both the 180 nm and 130 nm technology nodes. This study examines the extendibility of the Virtual Stepper System to 90nm technology node. The proposed method of simulation-based mask qualification uses aerial image defect simulation in combination with a next generation DUV inspection system with shorter wavelength (266nm) and small pixel size combined with DUV high-resolution microscope for some defect cases. This paper will present experimental results that prove the applicability for enabling 90nm technology nodes. Both contact and line/space patterns with varies programmed defects on ArF Attenuated PSM will be used. This paper will also address how to make the strategy production-worthy.

Nondestructive method for detecting defects in photodetector and solar cell devices

DOEpatents

Not Available

The invention described herein is a method for locating semiconductor device defects and for measuring the internal resistance of such devices by making use of the intrinsic distributed resistance nature of the devices. The method provides for forward-biasing a solar cell or other device while it is scanning with an optical spot. The forward-biasing is achieved with either an illuminator light source or an external current source.

Nondestructive method for detecting defects in photodetector and solar cell devices

DOEpatents

Sawyer, David E.

1981-01-01

The invention described herein is a method for locating semiconductor device defects and for measuring the internal resistance of such devices by making use of the intrinsic distributed resistance nature of the devices. The method provides for forward-biasing a solar cell or other device while it is scanning with an optical spot. The forward-biasing is achieved with either an illuminator light source or an external current source.

Retrieval of large Occlutech Figula Flex septal defect occluders using a commercially available bioptome: proof of concept.

PubMed

Georgiev, Stanimir; Tanase, Daniel; Genz, Thomas; Ewert, Peter; Naumann, Susanne; Pozza, Robert Dalla; Eicken, Andreas

2018-07-01

This study aimed to develop a method for retrieval of the new meshed nitinol atrial septal defect occluders - Ceraflex and Occlutech. The newly developed atrial septal defect occluders have potential benefits considering implantation, but concerns regarding their removal in case of embolisation have been raised. Over 21 years, 1449 patients underwent interventional atrial septal defect occlusion in our institution. We reviewed the cases of embolisation of the device, developed a strategy for device removal, and tested it on the benchside and in animal tests. In 11 patients (0.8%), the intended atrial septal defect occlusion was complicated by an embolisation of the device. In contrast to the Amplatzer septal occluders, retrieval of Occlutech devices larger than 16 mm with snare techniques was impossible. In benchside tests, this was confirmed and a new method for removal of large meshed devices was developed. This involved the commercially available Maslanka® biopsy forceps. The feasibility of this technique in vivo was tested in a pig model. During animal tests, using the Maslanka biopsy forceps it was possible to interventionally retrieve embolised Ceraflex and Occlutech devices of different sizes - 10, 16, 30, and 40 mm - into a 12-F sheath. It was impossible to retrieve Occlutech and Ceraflex devices larger than 16 mm into a large sheath in vivo and during benchside tests. However, this was feasible on the bench and in vivo using the Maslanka biopsy forceps even with the largest available devices.

Repair of Postoperative Abdominal Hernia in a Child with Congenital Omphalocele Using Porcine Dermal Matrix

PubMed Central

Mylona, E.; Tsakalidis, C.; Spyridakis, I.; Mitsiakos, G.; Karagianni, P.

2016-01-01

Introduction. Incisional hernias are a common complication appearing after abdominal wall defects reconstruction, with omphalocele and gastroschisis being the most common etiologies in children. Abdominal closure of these defects represents a real challenge for pediatric surgeons with many surgical techniques and various prosthetic materials being used for this purpose. Case Report. We present a case of repair of a postoperative ventral hernia occurring after congenital omphalocele reconstruction in a three-and-a-half-year-old child using an acellular, sterile, porcine dermal mesh. Conclusion. Non-cross-linked acellular porcine dermal matrix is an appropriate mesh used for the reconstruction of abdominal wall defects and their postoperative complications like large ventral hernias with success and preventing their recurrence. PMID:27110247

Repair of Postoperative Abdominal Hernia in a Child with Congenital Omphalocele Using Porcine Dermal Matrix.

PubMed

Lambropoulos, V; Mylona, E; Mouravas, V; Tsakalidis, C; Spyridakis, I; Mitsiakos, G; Karagianni, P

2016-01-01

Introduction. Incisional hernias are a common complication appearing after abdominal wall defects reconstruction, with omphalocele and gastroschisis being the most common etiologies in children. Abdominal closure of these defects represents a real challenge for pediatric surgeons with many surgical techniques and various prosthetic materials being used for this purpose. Case Report. We present a case of repair of a postoperative ventral hernia occurring after congenital omphalocele reconstruction in a three-and-a-half-year-old child using an acellular, sterile, porcine dermal mesh. Conclusion. Non-cross-linked acellular porcine dermal matrix is an appropriate mesh used for the reconstruction of abdominal wall defects and their postoperative complications like large ventral hernias with success and preventing their recurrence.