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Sample records for suture-mediated closure device

  1. Successful Angioplasty of a Superficial Femoral Artery Stenosis Caused by a Suture-Mediated Closure Device

    SciTech Connect

    Gemmete, Joseph J. Dasika, Narasimham; Forauer, Andrew R.; Cho, Kyung; Williams, David M.

    2003-08-15

    We report the successful angioplasty of an acute arterial narrowing after suture-mediated closure (SMC) of a femoral arterial puncture. A 75-year-old woman underwent a cerebral arteriogramvia a right common femoral artery puncture. The arteriotomy site was closed with a SMC device. Four days after placement the patient complained of pain in her right calf after walking. An arteriogram 7 days after SMC showed a severe focal stenosis at the origin of the superficial femoral artery involving the presumed puncture site. The lesion was successfully treated with balloon angioplasty. The patient at 6 months was asymptomatic.

  2. 24h and 30 day outcome of Perclose Proglide suture mediated vascular closure device: An Indian experience.

    PubMed

    Vinayakumar, Desabandhu; Kayakkal, Shajudeen; Rajasekharan, Sandeep; Thottian, Julian Johny; Sankaran, Prasanth; Bastian, Cicy

    Advantages of vascular closure device over manual compression include patient comfort, early mobilisation and discharge, avoidance of interruption of anticoagulation, avoidance of local compression and its sequelae and less time constraint on staff. No published Indian data exist regarding Perclose Proglide suture mediated vascular closure device (SMC). To study the 24h and 30 day outcome of Perclose Proglide SMC retrospectively. Retrospective observational study conducted in the Department of Cardiology, Government Medical College, Calicut, Kerala from June 2013 to June 2015. All consecutive patients with Perclose Proglide SMC deployment done by a single operator for achieving access site haemostasis where 24h and 30 day post-procedure data were available were included. Major and minor complications, procedure success, device failure were predefined. 323 patients were analysed. Procedure success rate was 99.7% (322/323). Transient oozing occurred in 44 patients (13.6%), minor and major complications occurred in 2% and 1.5% of patients respectively. Major complication included one case of retroperitoneal bleed, one access site infection, one pseudo aneurysm formation and two access site arterial stenosis. There was no death or complication requiring limb amputation. "Preclose" technique was used successfully in six patients. Primary device failure occurred in 12 cases which were tackled successfully with second Proglide in all except one. Perclose Proglide SMC is a safe and effective method to achieve haemostasis up to 22F with less complication rate. Copyright © 2016. Published by Elsevier B.V.

  3. Editor's choice. A randomized controlled trial of the fascia suture technique compared with a suture-mediated closure device for femoral arterial closure after endovascular aortic repair.

    PubMed

    Larzon, T; Roos, H; Gruber, G; Henrikson, O; Magnuson, A; Falkenberg, M; Lönn, L; Norgren, L

    2015-02-01

    The aim was to investigate whether the fascia suture technique (FST) can reduce access closure time and procedural costs compared with the Prostar technique (Prostar) in patients undergoing endovascular aortic repair and to evaluate the short- and mid-term outcomes of both techniques. In this two center trial, 100 patients were randomized to access closure by either FST or Prostar between June 2006 and December 2009. The primary endpoint was access closure time. Secondary outcome measures included access related costs and evaluation of the short- and mid-term complications. Evaluation was performed peri- and post-operatively, at discharge, at 30 days and at 6 months follow up. The median access closure time was 12.4 minutes for FST and 19.9 minutes for Prostar (p < .001). Prostar required a 54% greater procedure time than FST, mean ratio 1.54 (95% CI 1.25-1.90, p < .001) according to regression analysis. Adjusted for operator experience the mean ratio was 1.30 (95% CI 1.09-1.55, p = .005) and for patient body mass index 1.59 (95% CI 1.28-1.96, p < .001). The technical failure rate for operators at proficiency level was 5% (2/40) compared with 28% (17/59) for those at the basic level (p = .003). The proficiency level group had a technical failure rate of 4% (1/26) for FST and 7% (1/14) for Prostar, p = 1.00, while corresponding rates for the basic level group were 27% (6/22) for FST and 30% (11/37) for Prostar (p = .84). There was a significant difference in cost in favor of FST, with a median difference of €800 (95% CI 710-927, p < .001). In aortic endovascular repair FST is a faster and cheaper technique than the Prostar technique. Copyright © 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

  4. Endovascular Repair Using Suture-Mediated Closure Devices and Balloon Tamponade following Inadvertent Subclavian Artery Catheterization with Large-Caliber Hemodialysis Catheter.

    PubMed

    Park, Taek Kyu; Yang, Jeong Hoon; Choi, Seung-Hyuk

    2016-07-01

    Accidental subclavian artery cannulation is an uncommon but potentially serious complication of central venous catheterization. Removal of a catheter inadvertently placed in the subclavian artery can lead to substantial bleeding, as achieving hemostasis in this area through manual compression presents considerable difficulty. Additionally, surgical treatment might be unsuitable for high-risk patients due to comorbidities. Here, we report a case of an inadvertently-inserted 11.5-French hemodialysis catheter in the subclavian artery during internal jugular venous catheterization. We performed percutaneous closure of the subclavian artery using three 6-French Perclose Proglide® devices with a balloon tamponade in the proximal part of the subclavian artery. Closure was completed without embolic neurological complications.

  5. Closure device

    SciTech Connect

    Sable, D. E.

    1985-06-11

    A closure device connectible to a well head through which the polished rod of a rod string extends into a well tubing for operating pump means for moving well fluids to a surface flow conductor, the closure device having a tubular ram provided with a packing or plug for closing an annular passage between the polished rod and a tubular body connected to the well head above a lateral port of the tubular body, the tubular ram and the tubular body having thread means for moving the plug between an operative lower position wherein it closes the annular passage when the rod string is stationary and on inoperative upper position; seal means between the ram and the polished rod spaced above the plug; and a plurality of independent seal means between the ram and the tubular body operative when the plug is in its inoperative position. The plug of the closure device is especially adapted to operate under high temperature and pressure conditions of the well, as during steam injection operations when the rod string is stationary, to protect the seal means from high pressures and temperatures as well as any fluids which may be corrosive or otherwise deleterious to the substance of which the seal means are made.

  6. CLOSURE DEVICE

    DOEpatents

    Linzell, S.M.; Dorcy, D.J.

    1958-08-26

    A quick opening type of stuffing box employing two banks of rotatable shoes, each of which has a caraming action that forces a neoprene sealing surface against a pipe or rod where it passes through a wall is presented. A ring having a handle or wrench attached is placed eccentric to and between the two banks of shoes. Head bolts from the shoes fit into slots in this ring, which are so arranged that when the ring is rotated a quarter turn in one direction the shoes are thrust inwardly to cramp the neopnrene about the pipe, malting a tight seal. Moving the ring in the reverse direction moves the shoes outwardly and frees the pipe which then may be readily removed from the stuffing box. This device has particular application as a closure for the end of a coolant tube of a neutronic reactor.

  7. CIRSE Vascular Closure Device Registry

    SciTech Connect

    Reekers, Jim A.; Mueller-Huelsbeck, Stefan; Libicher, Martin; Atar, Eli; Trentmann, Jens; Goffette, Pierre; Borggrefe, Jan; Zelenak, Kamil; Hooijboer, Pieter; Belli, Anna-Maria

    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 (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.

  8. A new device for paravalvular leak closure

    PubMed Central

    Ercan, Ertugrul; Tengiz, Istemihan; Turk, Ugur; Ozyurtlu, Ferhat; Alioglu, Emin

    2015-01-01

    Percutaneous closure of a prosthetic paravalvular leak (PVL) is a challenging procedure. Operators must use devices constructed for other applications. We present the use of a device which is specifically designed for PVL closure. To the best of our knowledge, there is no publication in MEDLINE reporting the use of the device. PMID:25870623

  9. Patent Foramen Ovale: Stroke and Device Closure.

    PubMed

    Suradi, Hussam S; Hijazi, Ziyad M

    2016-05-01

    Patent foramen ovale (PFO) is a common finding in healthy adults and has long been implicated in cryptogenic stroke. The pathogenesis is hypothesized to be caused by microemboli gaining access into the systemic circulation via a PFO. Proposed treatment options include medical therapy and/or PFO closure. Despite numerous studies and several randomized trials, much debate persists regarding the efficacy of this approach in reducing the risk of recurrent stroke in cryptogenic stroke patients. This article reviews the association between PFO and cryptogenic stroke, as well as current evidence for PFO device closure. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. 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.

  11. Left Atrial Appendage Closure Devices

    PubMed Central

    Romero, Jorge; Perez, Irving E; Krumerman, Andrew; Garcia, Mario J; Lucariello, Richard J

    2014-01-01

    Atrial fibrillation (AF) increases the risk for thromboembolic stroke five-fold. The left atrial appendage (LAA) has been shown to be the main source of thrombus formation in the majority of strokes associated with AF. Oral anticoagulation with warfarin and novel anticoagulants remains the standard of care; however, it has several limitations, including bleeding and poor compliance. Occlusion of the LAA has been shown to be an alternative therapeutic approach to drug therapy. The purpose of this article is to review the different techniques and devices that have emerged for the purpose of occluding this structure, with a particular emphasis on the efficacy and safety studies published to date in the medical literature. PMID:24963274

  12. 49 CFR 178.360-4 - Closure devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS SPECIFICATIONS FOR PACKAGINGS Specifications for Packagings for Class 7 (Radioactive) Materials § 178.360-4 Closure devices. (a) Each closure...

  13. Vascular Closure Devices in Interventional Radiology Practice.

    PubMed

    Patel, Rafiuddin; Muller-Hulsbeck, Stefan; Morgan, Robert; Uberoi, Raman

    2015-08-01

    Manual compression (MC) is a well-established technique for haemostasis following percutaneous arterial intervention. However, MC is labour and time intensive with potential limitations, particularly for patients who are coagulopathic, unable to comply with bed rest or obese and when large sheaths or anti-coagulants are used. There are a variety of vascular closure devices (VCDs) available to overcome these limitations. This review gives an overview of current VCDs, their mechanism of action, individual strengths and weaknesses, evidence base and utility in interventional radiology (IR) practice. The majority of the published evidence on VCDs is derived from patients undergoing cardiac interventions, which should be borne in mind when considering the applicability and transfer of this data for general IR practice. Overall, the evidence suggests that most VCDs are effective in achieving haemostasis with a similar rate of complications to MC although the complication profile associated with VCDs is distinct to that of MC. There is insufficient evidence to comparatively analyse the different types of VCDs currently available or reliably judge their cost-effectiveness. The interventional radiologist should have a thorough understanding of the available techniques for haemostasis and be able to identify and utilise the most appropriate strategy and closure technique for the individual patient.

  14. Vascular Closure Devices in Interventional Radiology Practice

    SciTech Connect

    Patel, Rafiuddin; Muller-Hulsbeck, Stefan; Uberoi, Raman

    2015-08-15

    Manual compression (MC) is a well-established technique for haemostasis following percutaneous arterial intervention. However, MC is labour and time intensive with potential limitations, particularly for patients who are coagulopathic, unable to comply with bed rest or obese and when large sheaths or anti-coagulants are used. There are a variety of vascular closure devices (VCDs) available to overcome these limitations. This review gives an overview of current VCDs, their mechanism of action, individual strengths and weaknesses, evidence base and utility in interventional radiology (IR) practice. The majority of the published evidence on VCDs is derived from patients undergoing cardiac interventions, which should be borne in mind when considering the applicability and transfer of this data for general IR practice. Overall, the evidence suggests that most VCDs are effective in achieving haemostasis with a similar rate of complications to MC although the complication profile associated with VCDs is distinct to that of MC. There is insufficient evidence to comparatively analyse the different types of VCDs currently available or reliably judge their cost-effectiveness. The interventional radiologist should have a thorough understanding of the available techniques for haemostasis and be able to identify and utilise the most appropriate strategy and closure technique for the individual patient.

  15. 49 CFR 178.360-4 - Closure devices.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY... Packagings for Class 7 (Radioactive) Materials § 178.360-4 Closure devices. (a) Each closure device must be... subchapter). A torque wrench must be used in securing the flange with a corresponding torque of no more than...

  16. 49 CFR 178.360-4 - Closure devices.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY... Packagings for Class 7 (Radioactive) Materials § 178.360-4 Closure devices. (a) Each closure device must be... subchapter). A torque wrench must be used in securing the flange with a corresponding torque of no more than...

  17. 49 CFR 178.360-4 - Closure devices.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY... Packagings for Class 7 (Radioactive) Materials § 178.360-4 Closure devices. (a) Each closure device must be... subchapter). A torque wrench must be used in securing the flange with a corresponding torque of no more than...

  18. Use of an ePTFE-covered nitinol self-expanding stent graft for the treatment off pre-closure device failure during transcatheter aortic valve replacement.

    PubMed

    Steinvil, Arie; Bernardo, Nelson; Rogers, Toby; Koifman, Edward; Buchanan, Kyle; Alraies, M Chadi; Shults, Christian; Torguson, Rebecca; Okubagzi, Petros G; Pichard, Augusto D; Satler, Lowell F; Ben-Dor, Itsik; Waksman, Ron

    2017-03-01

    Our aim was to describe our experience with the use of an ePTFE-covered nitinol self-expanding stent graft (GORE® VIABAHN® Endoprosthesis, Gore Medical, USA) placed in the common femoral artery for the treatment of suture-mediated pre-closure device failure following transcatheter aortic valve replacement (TAVR). Access site-related vascular complications (VC) following sheath removal related to pre-closure device failure during TAVR are common and treatment options may vary. We performed an observational study on a series of consecutive patients who underwent TAVR between 2013 and 2015. Included were 25 patients at a mean (±SD) age of 82±9. Failure of the closure device resulted in overt bleeding in 19 patients, dissection or no flow in 5 patients, and angiographic pseudoaneurysm in 1. Overall 29 stents were deployed with diameters ranging from 8 to 11mm and a length of 50mm (26, 90%). All stent-graft deployments achieved complete hemostasis of the arteriotomy site and resulted in normal flow to the distal vessels. None of the patients required open surgical repair. The mean hemoglobin drop was 2.6±1.3g/dl. Blood transfusions were used in 15 (60%) patients. Acute kidney injury occurred in 4 (16%) patients, none of whom was treated with dialysis. Length of hospital stay was 9±5days. All patients survived during a 30-day follow-up period, and none had VC related to the stented site. The use of an ePTFE-covered Nitinol self-expanding stent graft is a feasible, safe, and effective treatment modality for access site-related VC following TAVR. The use of an ePTFE-covered nitinol self-expanding stent graft placed in the common femoral artery for the treatment of suture-mediated pre-closure device failure following transcatheter aortic valve replacement (TAVR) is described in 25 patients. Its use was found to be feasible, safe, and an effective treatment modality for access site-related vascular complications following TAVR. Copyright © 2016 Elsevier Inc. All

  19. Vascular Closure Device Failure: Frequency and Implications

    PubMed Central

    Bangalore, Sripal; Arora, Nipun; Resnic, Frederic S.

    2011-01-01

    Background Vascular closure devices (VCDs) are effective at reducing the time to ambulation for patients undergoing cardiac catheterization procedures, and in reducing the risk of vascular complications in selected patient cohorts. However, the frequency and consequence of failure of VCDs is not well defined. Methods and Results From a prospective registry of consecutive patients undergoing cardiac catheterization at our center, 9823 patients who received either a collagen-plug (Angio-Seal®) based or a suture-based (Perclose®) VCD were selected for the study. VCD failure was defined as unsuccessful deployment or failure to achieve hemostasis. Major vascular complication was defined as any retroperitoneal hemorrhage, limb ischemia, or any surgical repair. Minor vascular complication was defined as any groin bleeding, hematoma (≥ 5 cm), pseudoaneurysm or arteriovenous fistula. ‘Any’ vascular complication was defined as either a major or minor vascular complication. Among the 9823 patients in the study, VCD failed in 268 (2.7%; 2.3% diagnostic vs. 3.0% PCI; P = 0.029) patients. Patients with VCD failure had significantly increased risk of any (6.7% vs. 1.4%; P < 0.0001), major (1.9% vs. 0.6%; P = 0.006) or minor (6.0% vs. 1.1%; P < 0.0001) vascular complication compared with the group with successful deployment of VCD. The increased risk of vascular complication was unchanged in a propensity score matched cohort. Conclusions In contemporary practice, VCD failure is rare but when it does fail, it is associated with significant increase in the risk of vascular complications. Patients with VCD failure should be closely monitored to prevent vascular complications. PMID:20031773

  20. 33 CFR 154.520 - Closure devices.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) POLLUTION FACILITIES TRANSFERRING OIL OR HAZARDOUS MATERIAL IN BULK Equipment Requirements § 154.520 Closure... must have enough butterfly valves, wafer-type resilient seated valves, blank flanges, or other means...

  1. VASCULAR CLOSURE DEVICE FAILURE IN CONTEMPORARY PRACTICE

    PubMed Central

    Vidi, Venkatesan D.; Matheny, Michael E.; Govindarajulu, Usha S.; Normand, Sharon-Lise T.; Robbins, Susan L.; Agarwal, Vikram V.; Bangalore, Sripal; Resnic, Frederic S.

    2012-01-01

    Objectives To assess the frequency and predictors of vascular closure device (VCD) deployment failure, and its association with vascular complications of three commonly used VCDs. Background VCDs are commonly used following percutaneous coronary intervention (PCI) on the basis of studies demonstrating reduced time to ambulation, increased patient comfort, and possible reduction in vascular complications as compared to manual compression. However, limited data are available on the frequency and predictors of VCD failure, and the association of deployment failure with vascular complications. Methods From a de-identified dataset provided by Massachusetts Department of Health, 23,813 consecutive interventional coronary procedures that used either a collagen plug-based (n=18,533) or nitinol clip-based (n=2,284) or suture-based (n=2,996) VCD between 06/2005 and 12/2007 were identified. We defined VCD failure as unsuccessful deployment or failure to achieve immediate access site hemostasis. Results Among 23,813 procedures, VCD failed in 781 (3.3%) procedures (2.1% of collagen plug-based, 6.1% of suture-based, 9.5% of nitinol clip-based). Patients with VCD failure had excess risk of ‘any’ (7.7% versus 2.8%; P<0.001), major (3.3% versus 0.8%; P<0.001), or minor (5.8% versus 2.1%; P<0.001) vascular complications compared with successful VCD deployment. In a propensity-score adjusted analysis, when compared with collagen plug-based VCD (Reference OR =1.0), nitinol clip-based VCD had 2-fold increased risk (OR 2.0, 95% CI: 1.8–2.3, p<0.001) and suture-based VCD had 1.25-fold increased risk (OR 1.25, 95% CI: 1.2–1.3, p<0.001) for VCD failure. VCD failure was a significant predictor of subsequent vascular complications for both collagen plug-based VCD and nitinol clip-based VCD, but not for suture-based VCD. Conclusion VCD failure rates vary depending upon the types of VCD used and are associated with significantly higher vascular complications as compared to deployment

  2. Cardiac Device Implant Skin Closure with a Novel Adjustable, Coaptive Tape-Based Device.

    PubMed

    Lalani, Gautam G; Schricker, Amir A; Salcedo, Jonathan; Hebsur, Shrinivas; Hsu, Jonathan; Feld, Gregory; Birgersdotter-Green, Ulrika

    2016-10-01

    The purpose of this study was to compare a unique zip-type adjustable coaptive tape-based skin closure device to traditional subcuticular sutures in three domains: time, cosmesis, and wound closure-related outcomes in cardiac implantable electronic device (CIED) procedures. A total of 40 patients were enrolled in a prospective randomized controlled trial to assess time to wound closure, as well as cosmesis and wound closure-related outcomes. The adjustable coaptive tape-based skin closure device had shorter overall closure time (78 ± 6.6 seconds vs 216 ± 21.5 seconds; P < 0.001) and mean closure time per centimeter (18.0 ± 2.0 s/cm vs 50.1 ± 6.7 s/cm; P < 0.001) versus sutures, with less intersurgeon and interpatient variability with the use of adjustable coaptive device versus sutures (P < 0.001). There was no difference between groups in postoperative pain or scar cosmesis during the follow-up period. Neither group had any closure-related adverse events. The adjustable coaptive tape-based skin closure device demonstrated shorter closure times with less variability when compared to sutures. It is a safe and acceptable alternative to sutures for skin closure following CIED implantation. © 2016 Wiley Periodicals, Inc.

  3. Femoral Artery Stenosis Following Percutaneous Closure Using a Starclose Closure Device

    SciTech Connect

    Bent, Clare Louise; Kyriakides, Constantinos; Matson, Matthew

    2008-07-15

    Starclose (Abbott Vascular Devices, Redwood City, CA) is a new arterial closure device that seals a femoral puncture site with an extravascular star-shaped nitinol clip. The clip projects small tines into the arterial wall which fold inward, causing the arterial wall to pucker, producing a purse-string-like seal closing the puncture site. The case history is that of a 76-year-old female patient who underwent day-case percutaneous diagnostic coronary angiography. A Starclose femoral artery closure device was used to achieve hemostasis with subsequent femoral artery stenosis.

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

    SciTech Connect

    Schmelter, Christopher Liebl, Andrea; Poullos, Nektarios; Ruppert, Volker; Vorwerk, Dierk

    2013-06-15

    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 36 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.

  5. Use of Amplatzer device for endobronchial closure of bronchopleural fistulas.

    PubMed

    Kramer, Mordechai R; Peled, Nir; Shitrit, David; Atar, Eli; Saute, Milton; Shlomi, Dekel; Amital, Anat; Bruckheimer, Elchanan

    2008-06-01

    Bronchopulmonary fistula (BPF) is associated with high morbidity and mortality. It occurs as an uncommon but often severe complication of pneumonectomy. BPF may be treated by a range of surgical and medical techniques, including chest drain, Eloesser muscle flap, omental flap, transsternal bronchial closure, thoracoplasty, and prolonged therapy with antibiotic regimens. The use of bronchoscopy has been reported for the delivery of biological glue, coils, covered stents, and sealants. In this work, we describe a novel method of BPF closure using the Amplatzer device, which is commonly used for transcatheter closure of atrial septal defects.

  6. Efficacy and Safety of Augmenting the Preclose Technique with a Collagen-Based Closure Device for Percutaneous Endovascular Aneurysm Repair

    SciTech Connect

    Patel, Rafiuddin; Juszczak, Maciej T.; Bratby, Mark J.; Sideso, Ediri; Anthony, Susan; Tapping, Charles R.; Handa, Ashok; Darby, Christopher R.; Perkins, Jeremy; Uberoi, Raman

    2015-08-15

    PurposeTo report our experience of selectively augmenting the preclose technique for percutaneous endovascular aneurysm repair (p-EVAR) with an Angio-Seal device as a haemostatic adjunct in cases of significant bleeding after tensioning the sutures of the suture-mediated closure devices.Materials and MethodsProspectively collected data for p-EVAR patients at our institute were analysed. Outcomes included technical success and access site complications. A logistic regression model was used to analyse the effects of sheath size, CFA features and stent graft type on primary failure of the preclose technique necessitating augmentation and also on the development of complications.Resultsp-EVAR was attempted via 122 CFA access sites with a median sheath size of 18-French (range 12- to 28-French). Primary success of the preclose technique was 75.4 % (92/122). Angio-Seal augmentation was utilised as an adjunct to the preclose technique in 20.5 % (25/122). The overall p-EVAR success rate was 95.1 % (116/122). There was a statistically significant relationship (p = 0.0093) between depth of CFA and primary failure of preclose technique. CFA diameter, calcification, type of stent graft and sheath size did not have significant effects on primary preclose technique failure. Overall 4.9 % (6/122) required surgical conversion but otherwise there were no major complications.ConclusionAugmentation with an Angio-Seal device is a safe and effective adjunct to increase the success rate of the preclose technique in p-EVAR.

  7. Comparison of fasciotomy wound closures using traditional dressing changes and the vacuum-assisted closure device.

    PubMed

    Zannis, John; Angobaldo, Jeff; Marks, Malcolm; DeFranzo, Anthony; David, Lisa; Molnar, Joseph; Argenta, Louis

    2009-04-01

    Fasciotomy wounds can be a major contributor to length of stay for patients as well as a difficult reconstructive challenge. Once the compartment pressure has been relieved and stabilized, the wound should be closed as quickly and early as possible to avoid later complications. Skin grafting can lead to morbidity and scarring at both the donor and fasciotomy site. Primary closure results in a more functional and esthetic outcome with less morbidity for the patient, but can often be difficult to achieve secondary to edema, skin retraction, and skin edge necrosis. Our objective was to examine fasciotomy wound outcomes, including time to definitive closure, comparing traditional wet-to-dry dressings, and the vacuum-assisted closure (VAC) device. This retrospective chart review included a consecutive series of patients over a 10-year period. This series included 458 patients who underwent 804 fasciotomies. Of these fasciotomy wounds, 438 received exclusively VAC. dressings, 270 received only normal saline wet-to-dry dressings, and 96 were treated with a combination of both. Of the sample, 408 patients were treated with exclusively VAC therapy or wet-to-dry dressings and 50 patients were treated with a combination of both. In comparing all wounds, there was a statistically significant higher rate of primary closure using the VAC versus traditional wet-to-dry dressings (P < 0.05 for lower extremities and P < 0.03 for upper extremities). The time to primary closure of wounds was shorter in the VAC. group in comparison with the non-VAC group. This study has shown that the use of the VAC for fasciotomy wound closure results in a higher rate of primary closure versus traditional wet-to-dry dressings. In addition, the time to primary closure of wounds or time to skin grafting is shorter when the VAC was employed. The VAC used in the described settings decreases hospitalization time, allows for earlier rehabilitation, and ultimately leads to increased patient satisfaction.

  8. Testing Percutaneous Arterial Closure Devices: An Animal Model

    SciTech Connect

    Ni Ruifang; Kranokpiraksa, Pawanrat; Pavcnik, Dusan Kakizawa, Hideaki; Uchida, Barry T.; Keller, Frederick S.; Roesch, Josef

    2009-03-15

    The ovine superficial femoral artery was used for testing the efficacy of percutaneous arterial closure devices (PACDs) in their developmental stage. Two topical devices containing chitostan, one staple-mediated PACD and a porcine small intestinal submucosa plug, were tested by follow-up angiography in 37 sheep. Absence or presence of bleeding and time to bleeding cessation were the main criteria for evaluation of PAVD efficacy. The results of these tests directed modification of individual PACDs and improved their efficacy.

  9. Patent ductus arteriosus closure using an Amplatzer(™) ventricular septal defect closure device.

    PubMed

    Fernando, Rajeev; Koranne, Ketan; Loyalka, Pranav; Kar, Biswajit; Gregoric, Igor

    2013-01-01

    The ductus arteriosus originates from the persistence of the distal portion of the left sixth aortic arch. It connects the descending aorta (immediately distal to the left subclavian artery) to the roof of the main pulmonary artery, near the origin of the left pulmonary artery. Persistence of the duct beyond 48 h after birth is abnormal and results in patent ductus arteriosus (PDA). PDA is rare in adults because it is usually discovered and treated in childhood. Mechanical closure remains the definitive therapy because the patency of ductus arteriosus may lead to multiple complications, depending on the size and flow through the ductus. PDA closure is indicated in patients with symptoms and evidence of left heart enlargement, and in patients with elevated pulmonary pressures when reversal is possible. Transcatheter closure is the preferred technique in adults because it avoids sternotomy, reduces the length of hospital stay and is associated with fewer complications compared with surgery. First demonstrated in 1967, both the technique and the occluder devices used have since evolved. However, designing an ideal PDA occluder has been a challenge due to the variability in size, shape and orientation of PDAs. The present article describes a case involving a 35-year-old woman who presented to the Center for Advanced Heart Failure (Houston, USA) with congestive heart failure due to a large PDA, which was successfully occluded using an Amplatzer (St Jude Medical, USA) muscular ventricular septal defect closure device. The wider waist and dual-retention discs of these ventricular septal defect closure devices may be important factors to consider in the future development of devices for the occlusion of large PDAs.

  10. Patent ductus arteriosus closure using an Amplatzer™ ventricular septal defect closure device

    PubMed Central

    Fernando, Rajeev; Koranne, Ketan; Loyalka, Pranav; Kar, Biswajit; Gregoric, Igor

    2013-01-01

    The ductus arteriosus originates from the persistence of the distal portion of the left sixth aortic arch. It connects the descending aorta (immediately distal to the left subclavian artery) to the roof of the main pulmonary artery, near the origin of the left pulmonary artery. Persistence of the duct beyond 48 h after birth is abnormal and results in patent ductus arteriosus (PDA). PDA is rare in adults because it is usually discovered and treated in childhood. Mechanical closure remains the definitive therapy because the patency of ductus arteriosus may lead to multiple complications, depending on the size and flow through the ductus. PDA closure is indicated in patients with symptoms and evidence of left heart enlargement, and in patients with elevated pulmonary pressures when reversal is possible. Transcatheter closure is the preferred technique in adults because it avoids sternotomy, reduces the length of hospital stay and is associated with fewer complications compared with surgery. First demonstrated in 1967, both the technique and the occluder devices used have since evolved. However, designing an ideal PDA occluder has been a challenge due to the variability in size, shape and orientation of PDAs. The present article describes a case involving a 35-year-old woman who presented to the Center for Advanced Heart Failure (Houston, USA) with congestive heart failure due to a large PDA, which was successfully occluded using an Amplatzer (St Jude Medical, USA) muscular ventricular septal defect closure device. The wider waist and dual-retention discs of these ventricular septal defect closure devices may be important factors to consider in the future development of devices for the occlusion of large PDAs. PMID:24294051

  11. Iatrogenic Claudication from a Vascular Closure Device after Cardiac Catheterization

    PubMed Central

    Hermann, Luke; Chow, Evelyn; Duvall, W. Lane

    2010-01-01

    We report a case of iatrogenic claudication as a result of a misplaced percutaneous arterial closure device (PACD) used to obtain hemostasis after cardiac catheterization. The patient presented one week after his procedure with complaints suggestive of right lower extremity claudication. Computed tomographic angiography demonstrated a near total occlusion of the right common femoral artery from a PACD implemented during the cardiac catheterization. The use of PACD’s to obtain rapid hemostasis is estimated to occur in half of all cardiac catheterizations. Ischemic complications as a result of these devices must be considered when evaluating post procedural patients with extremity complaints. PMID:21293776

  12. 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)

  13. 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

  14. 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.

  15. [Ductus closure in adults with the Rashkind device: comparative results].

    PubMed

    Novo García, E; Bermúdez, R; Herraiz, I; Salgado, A; Balaguer, J; Moya, J L; Pinto, J

    1999-03-01

    Catheter occlusion of the persistent ductus arteriosus with Rashkind device is an alternative to the surgical closure demonstrated in children, however a few results have been reported of occlusion in adults. From 1990 to 1996 in 127 patients with persistent ductus arteriosus undergoing occlusion by Raskind device. Two groups according age: 105 children (< 14 years) and 22 adults (> 14 years), were studied retrospectively. The results were analysed by immediate aortogram and follow-up at 24 hours, 6 and 12 months by color-Doppler echocardiograms. The adults were frequently asymptomatic (86%) and with high incidence (59%) of silent ductus. Similar QP/QS (1.61 +/- 0.47 in adults vs 1.49 +/- 0.51) was calculated although pulmonary pressure was superior in children (12.50 +/- 2.97 vs 16.84 +/- 5.88 mmHg; p = 0.003). In group > 14 years the ductal anatomy favorable (Krichenko type A or B) was more frequent (91% vs 73%; p = 0.06) and ductal diameter significantly higher (3.03 +/- 1.50 vs 2.41 +/- 0.96 mm; p = 0.009). In adults 17 mm umbrella were used more frequently (91 vs 61%; p = 0.02). Absence complications (embolization, bacteremia, haemolysis, proximal stenosis of the left pulmonary artery) were found in adults against 4.72% in children. The occlusion were more effective in adults specially in early controls: 55% vs 34% (p = 0.09), 82% vs 69%, 91% vs 77% and 95% vs 83% (p > 0.10). Multivariate analysis identified age as an independent predictor of complete occlusion. Our experience in transcatheter occlusion of persistent ductus arteriosus with Rashkind device in adults support the efficacy, safety and excellent early results despite higher incidence of silent asymptomatic ductus.

  16. Delayed spontaneous perforation of polyvinyl alcohol membrane-Covered atrial septal defect closure devices.

    PubMed

    Labombarda, Fabien; Roule, Vincent; Beygui, Farzin

    2017-03-01

    Percutaneous device closure has become the first choice for secundum atrial septal defect (ASD) closure when feasible in case of favorable anatomy. The Ultrasept II ASD occluder® device (Cardia Inc, Eagan, MN) is made of two nitinol disc frames covered with polyvinyl alcohol membranes, a synthetic polymer with a large application in the biomedical field. Four relatively early malfunctions of the polyvinyl alcohol membrane were observed in a series of six consecutive patients treated with ASD Ultrasept II closure device in our institution. Operators have to be aware of this apparently rare complication that is likely to be underestimated, associated with such devices. © 2016 Wiley Periodicals, Inc.

  17. A comparison of arterial closure devices to manual compression in liver transplantation candidates undergoing coronary angiography.

    PubMed

    MacDonald, Lee A; Beohar, Nirat; Wang, Norman C; Nee, Lisa; Chandwaney, Raj; Ricciardi, Mark J; Benzuly, Keith H; Meyers, Sheridan N; Gheorghiada, Mihai; Davidson, Charles J

    2003-02-01

    Whether arterial closure devices can be used safely in a coagulopathic population undergoing cardiac catheterization and at high risk for groin complications, such as liver transplant candidates, is unknown. In this prospective, non-randomized consecutive series of 80 liver transplant candidates undergoing coronary angiography, manual compression and arterial closure devices were compared. Ilio-femoral angiography was performed to determine suitability for use of the closure device. Bleeding and vascular complications were recorded along with time to ambulation. Arterial closure devices were used in 31 patients (39%), whereas manual compression was used in 49 patients (50 procedures) (61%). There were no significant differences between the two groups with respect to age, sex, cardiac risk factors, peripheral vascular disease, baseline platelet count or baseline INR. There were 10 total vascular complications out of 50 procedures (20%) in the manual compression group compared to 2 vascular complications out of 31 procedures in the arterial closure device group (6%; p = 0.12). The time to ambulation was significantly less in the group receiving arterial closure devices versus manual compression (4.2 1.8 hours versus 6.6 3.7 hours, respectively; p = 0.0003). In coagulopathic patients at higher risk for groin complications, arterial closure devices can be safely used and decrease time to ambulation compared to manual compression.

  18. [Early migration of the device for transcatheter closure of atrial septal defect. Case report].

    PubMed

    Santos, Nelson; Guerra, Miguel; Neves, Fátima; Gonçalves, Manuel; Gama, Vasco; Mota, João; Vouga, Luis

    2007-01-01

    The transcatheter closure of the atrial septal defect (ASD) has been proposed as an alternative to surgical therapy for the ostium secundum ASD. It is considered an effective and safe procedure, although rare but potentially fatal complications have been reported. The authors report a case of early migration of a device for transcatheter closure of an ASD to the right pulmonary artery.

  19. New skin closure system facilitates wound healing after cardiovascular implantable electronic device surgery.

    PubMed

    De Maria, Elia

    2015-08-16

    The manuscript describes the efficacy of a new skin closure system (ZipLine™) for wound closure after pacemaker/implantable cardioverter defibrillator surgery. The system is particularly useful when wound healing is difficult with traditional methods and in patients at high risk for surgical site infections (SSIs). This skin closure option is easy and quick to apply and remove, and produces excellent cosmetic results. Although it is associated with a minimal expense upcharge, the benefits, including the potential for decrease in SSI, make it attractive and worth considering for skin closure in device patients, particularly those at increased risk of complications.

  20. Comparative study of the transcatheter and transthoracic device closure treatments for atrial septal defect

    PubMed Central

    Chen, Qiang; Cao, Hua; Chen, Zhao-yang; Zhang, Gui-Can; Chen, Liang-wan; Xu, Fan; He, Jia-jun

    2017-01-01

    Abstract The purpose of this study was to compare patient populations, safety, feasibility, complications, and total costs of the transcatheter and transthoracic device closure treatments for secundum atrial septal defect. From January 2014 to December 2014, we enrolled 155 patients with secundum atrial septal defects in our hospital. The patients were divided into 2 groups: the 70 patients in group A underwent transcatheter device closure, and the 85 patients in group B underwent transthoracic intraoperative device closure with a right lateral mini-thoracotomy. In group A, the total occlusion rate was 94.3% immediately after the operation, 100% at 3 months, and 100% at 12 months of follow-up; the group A results were not statistically different from the group B results (94.1%, 98.8%, 98.8%, respectively). There was a statistically significant difference in the minor complication rate (P < 0.05), and there were no reported deaths. There was a greater indicated scope using the transthoracic closure device to treat atrial septal defects. In our comparative study, the patients in group B had longer intensive care unit stays and hospital stays than group A (P < 0.05). Both of the device closure treatment options for secundum atrial septal defect are safe and feasible. The transcatheter device closure approach has the advantages of more cosmetic results, less trauma, and a shorter hospital stay than the transthoracic approach. On the contrary, the transthoracic closure device is an economical alternative choice, particularly for patients who are not eligible for the transcatheter closure device. PMID:28296745

  1. 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.

  2. Vascular closure devices for femoral arterial puncture site haemostasis.

    PubMed

    Robertson, Lindsay; Andras, Alina; Colgan, Frances; Jackson, Ralph

    2016-03-07

    Vascular closure devices (VCDs) are widely used to achieve haemostasis after procedures requiring percutaneous common femoral artery (CFA) puncture. There is no consensus regarding the benefits of VCDs, including potential reduction in procedure time, length of hospital stay or time to patient ambulation. No robust evidence exists that VCDs reduce the incidence of puncture site complications compared with haemostasis achieved through extrinsic (manual or mechanical) compression. To determine the efficacy and safety of VCDs versus traditional methods of extrinsic compression in achieving haemostasis after retrograde and antegrade percutaneous arterial puncture of the CFA. The Cochrane Vascular Trials Search Co-ordinator searched the Specialised Register (April 2015) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2015, Issue 3). Clinical trials databases were searched for details of ongoing or unpublished studies. References of articles retrieved by electronic searches were searched for additional citations. We included randomised and quasi-randomised controlled trials in which people undergoing a diagnostic or interventional procedure via percutaneous CFA puncture were randomised to one type of VCD versus extrinsic compression or another type of VCD. Two authors independently extracted data and assessed the methodological quality of trials. We resolved disagreements by discussion with the third author. We performed meta-analyses when heterogeneity (I(2)) was < 90%. The primary efficacy outcomes were time to haemostasis and time to mobilisation (mean difference (MD) and 95% confidence interval (CI)). The primary safety outcome was a major adverse event (mortality and vascular injury requiring repair) (odds ratio (OR) and 95% CI). Secondary outcomes included adverse events. We included 52 studies (19,192 participants) in the review. We found studies comparing VCDs with extrinsic compression (sheath size ≤ 9 Fr), different VCDs with each other

  3. Vacuum with mesh is a feasible temporary closure device after fascial dehiscence.

    PubMed

    Bjørsum-Meyer, Thomas; Skarbye, Mona; Jensen, Kenneth Højsgaard

    2013-11-01

    The open abdomen is a challenging condition and a temporary abdominal closure device is required in order to protect the intra-abdominal viscera. We aimed to evaluate the feasibility of a recent device: vacuum-assisted wound closure and mesh-mediated fascial traction (VAWCM) after fascial dehiscence focusing on fascial closure rate, mortality and procedure-related complications. We performed a retrospective study on 18 patients treated with VAWCM after fascial dehiscence who were consecutively admitted to the Department of Surgery, Slagelse Hospital, between October 2008 and October 2012. The 18 patients had a median age of 64 (29-90) years. 80% (12/15) obtained delayed primary abdominal closure. The in-hospital mortality was 17% (3/18). The median treatment period with VAWCM and vacuum-assisted wound closure were 18 (7-34) and 21 (7-53) days, respectively, with a median of six (1-11) tightenings. One patient developed an intra-abdominal abscess. Three patients survived until discharge without having obtained delayed primary closure. In two of these patients, the fascial edges were adapted with a prosthetic mesh and one patient was left with a planned ventral hernia. We performed a retrospective follow-up with a median duration of 21 months 21% developed an incisional hernia. Two patients died within 60 days after closure of the abdomen. We found and that VAWCM is a safe and useful technique for delayed primary closure of the open abdomen after fascial dehiscence. We stress the need for more studies on temporary abdominal closure devices in selected groups of patients. not relevant. not relevant.

  4. Late onset iatrogenic limb ischaemia after deployment of an Angio-Seal vascular closure device.

    PubMed

    Krishna, Rama K; Kherada, Nisharahmed; Beohar, Nirat

    2015-04-26

    It is common practice to deploy a vascular closure device for access site closure after percutaneous angiography or cardiovascular interventions for immediate haemostasis and to facilitate early discharge. We encountered two octogenarian women who underwent and had subsequent vascular access site closure with Angio-Seal (St Jude) and who later presented with limb ischaemia needing surgical revascularisation. Our patients had undergone uneventful deployment of the Angio-Seal vascular closure device (VCD) at the right common femoral artery (CFA) access site with successful haemostasis. About 3 weeks later they presented with features of limb ischaemia needing further diagnostic work-up including repeat angiography, which revealed subtotal occlusion of right common femoral artery at the level of prior access and Angio-Seal deployment site. Both the patients underwent successful surgical repair with restoration of distal flow and resolution of symptoms. These cases illustrate the late presentation of VCD-related complications with limb ischaemia, needing surgical revascularisation.

  5. Intraoperative device closure of atrial septal defects in the Older Population

    PubMed Central

    2011-01-01

    Objective This study sought to prove the safety and feasibility of intraoperative device closure of atrial septal defect (ASD) with transthoracic minimal invasion in the older patients. Methods From January 2006 to December 2009, 47 patients aged 50 years or more and suffered from atrial septal defect were enrolled in our institution. Patients were divided into two groups, 27 of which in group I with intraoperative device closure and the other 20 in group II with surgical closure. In group I, the method involved a minimal intercostal incision, which was performed after full evaluation of the atrial septal defect by transthoracic echocardiography, and the insertion of the device through the delivery sheath to occlude the atrial septal defect. Results In group I, implantation was ultimately successful in all patients. The complete closure rate at 24 hours and 1 year were 81.5% and 100% respectively. In 6 of 27 patients, minor complications occurred: transient arrhythmia (n = 5) and blood transfusion (n = 3). In group II, all patients were closured successfully; almost all of them needed blood transfusion and suffered from various minor complications though. During a follow-up period of 1 to 5 years, no residual shunt, noticeable mitral regurgitation, significant arrhythmias, thrombosis, or device failure were found. In our comparative studies, group II had significantly longer ICU stay and hospital stay than group I (p < 0.05). The cost of group I was less than that of group II(p < 0.05). Conclusions Minimally invasive transthoracic device closure of the atrial septal defect at advanced age with a domestically made device without cardiopulmonary bypass is safe and feasible under transthoracic echocardiographic guidance. It was cost-savings, yielding better cosmetic results and leaving fewer traumas than surgical closure. Early and mid-term results are encouraging. However, it is necessary to evaluate the long-term results. PMID:21958758

  6. Gastrotomy closure with a new tissue anchoring device: A porcine survival study

    PubMed Central

    Guarner-Argente, Carlos; Córdova, Henry; Martínez-Pallí, Graciela; Navarro-Ripoll, Ricard; Rodríguez-d’Jesús, Antonio; de Miguel, Cristina Rodríguez; Beltrán, Mireia; Fernández-Esparrach, Gloria

    2011-01-01

    AIM: To evaluate the feasibility, reproducibility and efficacy of a new tissue anchoring device in a porcine survival model. METHODS: Gastrotomies were performed using a needle-knife and balloon dilator in 10 female Yorkshire pigs weighing 30-35 kg. Gastric closure was attempted using a new tissue anchoring device. The tightness of the closure was confirmed by means of air insufflation and the ability to maintain gastric distension with stability in peritoneal pressure measured with a Veress needle. All animals were monitored daily for signs of peritonitis and sepsis over 14 d. During necropsy, the peritoneal cavity and the gastric access site were examined. RESULTS: Transgastric access, closure and 14 d survival was achieved in all pigs. The mean closure time was 18.1 ± 19.2 min and a mean of 2.1 ± 1 devices were used. Supplementary clips were necessary in 2 cases. The closure time was progressively reduced (24.8 ± 13.9 min in the first 5 pigs vs 11.4 ± 5.9 min in the last 5, P = NS). At necropsy, the gastric access site was correctly closed in all cases with all brace-bars present. One device was misplaced in the mesocolon. Minimal adhesions were observed in 3 pigs and signs of mild peritonitis and adhesions in one. CONCLUSIONS: The use of this new tissue anchoring device in porcine stomachs is feasible, reproducible and effective and requires a short learning curve. PMID:21483634

  7. 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.

  8. Perventricular device closure of isolated muscular ventricular septal defect in infants: A single centre experience☆

    PubMed Central

    Thakkar, Bhavesh; Patel, Nehal; Shah, Shaunak; Poptani, Vishal; Madan, Tarun; Shah, Chirag; Shukla, Anand; Prajapati, Vaishali

    2012-01-01

    Objectives To evaluate prospective single centre experience of mid-term safety and efficacy of perventricular device closure of isolated large muscular ventricular septal defect (mVSD) in high-risk infants. Background Surgical closures of large mVSD in infants represent a challenge with significant morbidity. Methods Between August 2008–2010, perventricular closure was attempted in 24 infants of 6.01 ± 2.37 months age and 4.27 ± 0.56 kg weight under TEE guidance. Results The device was successfully deployed in 21/24 infants. Size of mVSD was 8.42 ± 1.46 mm (6.1–12 mm). Mean procedure time was 28.8 ± 11.7 min. The closure rate was 84% immediately and 100% at 6 months. Four patients suffered major complications: 2-died, 1-esophageal perforation, 1-persistent CHB. At 26.23 ± 6.63 months follow-up two patients were symptomatic: 1-required device retrieval, 1-died of severe gastroenteritis. Conclusion Perventricular device closure of isolated mVSD appears feasible option at mid-term follow-up and may either substitute or complement the conventional surgical technique in selected cases depending on institutional paediatric cardiac surgery performance. PMID:23253407

  9. 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

  10. [Percutaneous closure of atrial septal defects with the Amplatzer® device: 15 years of experience].

    PubMed

    Zabal-Cerdeira, Carlos; García-Montes, José Antonio; Sandoval-Jones, Juan Pablo; Calderón-Colmenero, Juan; Patiño-Bahena, Emilia; Juanico-Enríquez, Antonio; Buendía-Hernández, Alfonso

    2014-01-01

    Percutaneous closure of atrial septal defects is an alternative to surgical treatment. We report the results of percutaneous closure of atrial septal defects with the Amplatzer(®) device. We include patients taken to the catheterization laboratory from September 1997 to December 2011. We proceeded with defect closure in 721 patients and in 85 the defect was considered not suitable for closure. The stretched diameter of the defect was 23±6.7mm (limits, 5-42). All devices were positioned successfully. In 15 cases (2.1%) the device was changed due to instability and in 6 (0.8%) the device embolized within the first 24h, 4 were retrieved and repositioned (final success with intention to treat 719/806-89.2%). Immediate control showed complete closure in 247 patients (34.3%), leak through the device in 395 (54.9%), mild residual leak in 75 (10.4%) and moderate in 2 (0.3%). We have follow-up in 626 patients (87.1%) for 33±27.5 months, with headache in 54 (8.6%), new supraventricular arrhythmia in 10 (1.6%), puncture site complications in 4 (0.6%), and stroke in one (0.1%). The design of the Amplatzer(®) device allows effective closure of atrial septal defects with a simple technique and patient safety. Copyright © 2013 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

  11. Delayed Left Atrial Perforation Associated with Erosion After Device Closure of an Atrial Septal Defect

    PubMed Central

    Kim, Ji Seong; Yeom, Sang Yoon; Kim, Sue Hyun; Choi, Jae Woong; Kim, Kyung Hwan

    2017-01-01

    A 43-year-old man who had had a history of atrial septal defect (ASD) device closure 31 months previously presented with abrupt chest and back pain along with progressive cardiogenic shock and cardiac arrest. After resuscitation, he was diagnosed with cardiac tamponade. Diagnostic and therapeutic surgical exploration revealed left atrium (LA) perforation due to LA roof erosion from a deficient aortic rim. Device removal, primary repair of the LA perforation site, and ASD patch closure were performed successfully. The postoperative course was uneventful. The patient was discharged after 6 weeks of empirical antibiotic therapy without any other significant complications. PMID:28382270

  12. Percutaneous aortic valve closure for patients with left ventricular assist device-associated aortic insufficiency.

    PubMed

    Alkhouli, Mohamad; Melito, Betsy; Ling, Frederick S

    2016-12-01

    The development of de novo aortic insufficiency (AI) is a significant complication of long-term LVAD support, which can lead to ineffective support, decreased device durability, end organ malperfusion, and increased mortality. Surgical aortic valve (AV) closure has been the standard treatment for symptomatic patients, but is associated with high mortality and recurrence of AI. Percutaneous AV closure using the Amplatzer cribriform device is a feasible and may be the preferable option to treat LVAD-associated severe AI in high-surgical risk patients. Certain technical issues with this procedure should be taken into consideration to achieve optimal results. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  13. 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

  14. Closure Using a Surgical Closure Device of Inadvertent Subclavian Artery Punctures During Central Venous Catheter Placement

    SciTech Connect

    Berlet, Matthew H.; Steffen, Diana; Shaughness, George; Hanner, James

    2001-03-15

    Severe complications can and do occur when central venous catheters are inadvertently placed into subclavian arteries. Two cases are discussed that describe how these inadvertent arterial punctures can be closed using the Perclose device (Abbott Laboratories, Redwood City, CA, USA)

  15. Intraoperative Device Closure of Atrial Septal Defects with Minimal Transthoracic Invasion

    PubMed Central

    Zhu, Peng; Sun, Yong; Yang, Qian; Qiu, Feng

    2013-01-01

    Atrial septal defect is one of the most common congenital heart defects. Open-heart repair via midline sternotomy or right thoracotomy and cardiopulmonary bypass has been considered the standard treatment for the closure of atrial septal defects, but transcatheter closure with the Amplatzer septal occluder has recently become a viable option. We have adopted a 3rd alternative: intraoperative device closure with minimal transthoracic invasion. From May 2007 through June 2011, 250 patients with secundum atrial septal defect underwent cardiac surgery at our institution. Open-heart repair with cardiopulmonary bypass was performed in 72 patients, and intraoperative device closure was performed in 178 patients. This minimally invasive approach, which required a full evaluation of the atrial septal defect by transthoracic echocardiography, was performed by deploying the device through the delivery sheath to occlude the atrial septal defect. The approach was successful in 175 of the 178 patients. The size of the implanted occluder ranged from 12 to 46 mm in diameter. Minor complications included transient arrhythmias (n=7) and pleural effusion (n=25). After complete release, the intraoperative occluder device dislodged in the right atrium in 3 patients, who then underwent immediate surgical repair with cardiopulmonary bypass. All discharged patients were monitored for 2.3 years to 5 years. As monotherapy, intraoperative device closure of atrial septal defect with minimal transthoracic invasion is a safe and feasible technique. It is particularly beneficial for elderly patients or patients with pulmonary hypertension and is associated with better cosmetic results and less trauma than is surgical closure. PMID:23914014

  16. Device closure of secundum atrial septal defect's and the risk of cardiac erosion.

    PubMed

    Thomson, J D R; Qureshi, S A

    2015-12-01

    Cardiac erosion related to transcatheter atrial septal defect closure devices is of increasing concern. Erosion is reported to have occurred with most of currently available occluder devices. Perhaps due to the very large number of implants worldwide, the Amplatzer (St Jude) occluder is associated with the majority of cardiac erosion events reported in the literature. Best current estimates of the incidence of erosion with the St Jude device are between one and three cases per 1000 implants. Most events occur early after implantation and it is rare, although not unheard of, for events to occur after a year following device insertion. It is important that those involved with closure programmes are vigilant for the problem, because device-related erosion is associated with a significant mortality risk. Despite considerable debate, the risk factors (either patient or device) for erosion remain unclear and require further investigation. Currently available data sets have focussed largely on erosion cohorts and are unable to place these cases in appropriate context with non-erosion closure cases. What is certain is that programmes implanting these devices must take care to implant appropriately sized devices and have in place plans to ensure that patients are both well informed and can access help and advice in the event of developing symptoms.

  17. Endobronchial closure of bronchopleural fistulae using amplatzer devices: our experience and literature review.

    PubMed

    Fruchter, Oren; Kramer, Mordechai R; Dagan, Tamir; Raviv, Yael; Abdel-Rahman, Nader; Saute, Milton; Bruckheimer, Elchanan

    2011-03-01

    Bronchopulmonary fistulae (BPFs) are a severe complication of lobectomy and pneumonectomy and are associated with high rates of morbidity and mortality. We have developed a novel, minimally invasive method of central BPF closure using Amplatzer devices (ADs) that were originally designed for the transcatheter closure of cardiac defects. Ten patients with 11 BPFs (eight men and two women, aged 66.3±10.1 years [mean±SD]) were treated under conscious sedation with bronchoscopic closure of the BPFs using ADs. A nitinol double-disk occluder device was delivered under direct bronchoscopic guidance over a guidewire into the fistula. By extruding a disk on either side of the BPF, the fistula was occluded. Bronchography was performed by injecting contrast medium through the delivery sheath following the procedure to ensure correct device positioning. In nine patients, the procedure was successful and symptoms related to the BPF disappeared following closure by the AD. The results were maintained over a median follow-up period of 9 months. Therefore, we state that endobronchial closure using an AD is a safe and effective method for treatment of a postoperative BPF.

  18. Morphology of perforated atrial septal aneurysm suitable for closure by transcatheter device placement

    PubMed Central

    Ewert, P; Berger, F; Vogel, M; Dahnert, I; Alexi-Meshkishvil..., V; Lange, P

    2000-01-01

    OBJECTIVE—To define the morphological criteria of perforated atrial septal aneurysms suitable for closure by a transcatheter device.
METHODS—A retrospective analysis of all consecutive patients with atrial septal aneurysm and one or more perforations presenting between May 1997 and June 1999. The aneurysms were classified as: aneurysm with persistent foramen ovale (type A); aneurysm with single atrial septal defect (type B); aneurysm with two perforations requiring more than one device for closure (type C); and aneurysm with multiple perforations (type D).
PATIENTS—Data from 50 patients aged 5-78 years (mean 43 years) were analysed; 32 had systemic thromboembolism or transient ischaemic attacks, eight presented with dyspnoea on exercise, and 10 were discovered incidentally but had significant left to right shunt and right ventricular volume overload.
RESULTS—In all 18 patients with aneurysm and persistent foramen ovale (type A), transcatheter closure was possible. In nine with aneurysm and atrial septal defect (type B), five defects were closed and four required surgery. Device closure was achieved in all 10 patients with aneurysms and two perforations (type C), but four had a residual shunt. Thirteen patients with multiple perforated aneurysms (type D) underwent surgery.
CONCLUSIONS—This classification of morphology of perforations of aneurysm is clinically useful for selecting patients for treatment by transcatheter devices.


Keywords: aneurysm; atrial septum; transcatheter device PMID:10956300

  19. Safety and Feasibility of a Novel Vascular Closure Device in Neurointerventional Procedures

    PubMed Central

    Taha, Ammar; Walsh, Ellen K; Wright, Kathryn A; Ahmed, Iftikhar; Supakul, Nucharin; Awwad, Eric E; Tejada, Juan G.

    2013-01-01

    Summary This retrospective study evaluated the safety and feasibility of a new arterial femoral access closure device in neurointerventional procedures. The study includes all consecutive adult patients who underwent femoral arteriotomy closure with the MynxGrip™ closure device after Neurointerventional procedures performed between June and December 2012. All patients had a follow-up color Doppler ultrasound (US) within 48 hours after the procedure, which was independently interpreted by two experienced radiologists to evaluate for access site complications. Device success/failure, sheath size, ambulation time, and periprocedural complications were recorded. Fifty-five closure devices were deployed in 53 patients. There were 23 (43%) males and 30 (57%) females; age ranged from 22 to 84 years (mean: 52.1 years). Thirty of the 55 procedures (55%) were therapeutic and 25 were diagnostic interventions (45%). Sheath sizes used were 5F in 35 procedures (64 %) and 6F in 20 procedures (36%). The right femoral artery was accessed in 51 procedures (93 %) and the left in four procedures (7%). There was only one (1.8 %) minor periprocedural complication (small hematoma). Hemostasis was successful in 51 of the 55 procedures (93 %) with subsequent early ambulation. No device-induced complications associated with serious clinical sequelae were reported. In our small series, the MynxGrip™ femoral access closure device provided a safe and feasible way of closing the femoral artery puncture site after neurointerventional procedures with low minor complication rates and no major complications. Further large prospective randomized trials are necessary to evaluate the efficacy of the device. PMID:24070085

  20. Device Closure of Patent Foramen Ovale after Stroke: Pooled Analysis of Completed Randomized Trials

    PubMed Central

    Kent, David M.; Dahabreh, Issa J.; Ruthazer, Robin; Furlan, Anthony J.; Reisman, Mark; Carroll, John D.; Saver, Jeffrey L.; Smalling, Richard W.; Jüni, Peter; Mattle, Heinrich P.; Meier, Bernhard; Thaler, David E

    2015-01-01

    Background The comparative effectiveness of percutaneous closure of patent foramen ovale (PFO) plus medical therapy versus medical therapy alone for cryptogenic stroke is uncertain. Objectives We performed the first pooled analysis of individual participant data from completed randomized trials comparing PFO closure versus medical therapy in patients with cryptogenic stroke. Methods We analyzed data on 2 devices (STARFlex and Amplatzer PFO Occluder) evaluated in 3 trials. The primary composite outcome was stroke, transient ischemic attack (TIA), or death; the secondary outcome was stroke. We used log-rank tests and (unadjusted and covariate-adjusted) Cox regression models to compare device closure versus medical therapy. Results Among 2,303 patients, closure was not significantly associated with the primary composite outcome. The difference became significant after covariate adjustment (hazard ratio [HR]: 0.68; p = 0.049). For the outcome of stroke, all comparisons were statistically significant, with unadjusted and adjusted HRs of 0.58 (p = 0.043) and 0.58 (p = 0.044), respectively. In analyses limited to the 2 occluder device trials, the effect of closure was not significant for the composite outcome, but was for the stroke outcome (unadjusted HR: 0.39; p = 0.013. Subgroup analyses did not identify significant heterogeneity of treatment effects. Atrial fibrillation was more common among closure patients. Conclusions Among patients with PFO and cryptogenic stroke, closure reduced recurrent stroke and had a statistically significant effect on the composite of stroke, TIA, and death in adjusted but not unadjusted analyses. PMID:26916479

  1. Device Closure of Patent Foramen Ovale After Stroke: Pooled Analysis of Completed Randomized Trials.

    PubMed

    Kent, David M; Dahabreh, Issa J; Ruthazer, Robin; Furlan, Anthony J; Reisman, Mark; Carroll, John D; Saver, Jeffrey L; Smalling, Richard W; Jüni, Peter; Mattle, Heinrich P; Meier, Bernhard; Thaler, David E

    2016-03-01

    The comparative effectiveness of percutaneous closure of patent foramen ovale (PFO) plus medical therapy versus medical therapy alone for cryptogenic stroke is uncertain. The authors performed the first pooled analysis of individual participant data from completed randomized trials comparing PFO closure versus medical therapy in patients with cryptogenic stroke. The analysis included data on 2 devices (STARFlex [umbrella occluder] [NMT Medical, Inc., Boston, Massachusetts] and Amplatzer PFO Occluder [disc occluder] [AGA Medical/St. Jude Medical, St. Paul, Minnesota]) evaluated in 3 trials. The primary composite outcome was stroke, transient ischemic attack, or death; the secondary outcome was stroke. We used log-rank tests and unadjusted and covariate-adjusted Cox regression models to compare device closure versus medical therapy. Among 2,303 patients, closure was not significantly associated with the primary composite outcome. The difference became significant after covariate adjustment (hazard ratio [HR]: 0.68; p = 0.049). For the outcome of stroke, all comparisons were statistically significant, with unadjusted and adjusted HRs of 0.58 (p = 0.043) and 0.58 (p = 0.044), respectively. In analyses limited to the 2 disc occluder device trials, the effect of closure was not significant for the composite outcome, but was for the stroke outcome (unadjusted HR: 0.39; p = 0.013). Subgroup analyses did not identify significant heterogeneity of treatment effects. Atrial fibrillation was more common among closure patients. Among patients with PFO and cryptogenic stroke, closure reduced recurrent stroke and had a statistically significant effect on the composite of stroke, transient ischemic attack, and death in adjusted but not unadjusted analyses. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

    SciTech Connect

    Joseph, George Kunwar, Brajesh Kumar

    2013-06-15

    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 stabilization can be a valuable option during device closure of large PAVMs when advancement, stability, or kinking of the device delivery sheath is an issue.

  3. Amplatzer device and vacuum-assisted closure therapy to treat a thoracic empyema with bronchopleural fistula.

    PubMed

    Passera, Eliseo; Guanella, Giovanni; Meroni, Alberto; Chiesa, Giuseppe; Rizzi, Adriano; Rocco, Gaetano

    2011-08-01

    We present a case of lower bilobectomy complicated by a large bronchopleural fistula and empyema 1 month after primary surgery. The patient was immediately treated with an open window thoracostomy. After surgical debridement, an Amplatzer Septal Occluder device (AGA Medical Corp, Plymouth, MN) was positioned to close the fistula. Thereafter, the thoracostomy rapidly and spontaneously closed with vacuum-assisted closure therapy.

  4. 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

  5. Cardiac CT angiography for device surveillance after endovascular left atrial appendage closure

    PubMed Central

    Saw, Jacqueline; Fahmy, Peter; DeJong, Peggy; Lempereur, Mathieu; Spencer, Ryan; Tsang, Michael; Gin, Kenneth; Jue, John; Mayo, John; McLaughlin, Patrick; Nicolaou, Savvas

    2015-01-01

    Aims Left atrial appendage (LAA) device imaging after endovascular closure is important to assess for device thrombus, residual leak, positioning, surrounding structures, and pericardial effusion. Cardiac CT angiography (CCTA) is well suited to assess these non-invasively. Methods and results We report our consecutive series of non-valvular atrial fibrillation patients who underwent CCTA post-LAA closure with Amplatzer Cardiac Plug (ACP), Amulet (second generation ACP), or WATCHMAN devices. Patients underwent CCTA typically 1–6 months post-implantation. Prospective cardiac-gated CCTA was performed with Toshiba 320-detector or Siemens 2nd generation 128-slice dual-source scanners, and images interpreted with VitreaWorkstation™. GFR <30 mL/min/1.73 m2 was an exclusion. We assessed for device thrombus, residual LAA leak, device embolization, position, pericardial effusion, optimal implantation, and device lobe dimensions. Forty-five patients underwent CCTA at median 97 days post-LAA closure (18 ACP, 9 Amulet, 18 WATCHMAN). Average age was 75.5 ± 8.9 years, mean CHADS2 score 3.1 ± 1.3, and CHADS-VASc score 4.9 ± 1.6. All had contraindications to oral anticoagulation. Post-procedure, 41 (91.1%) were discharged on DAPT. There was one device embolization (ACP, successfully retrieved percutaneously) and one thrombus (WATCHMAN, resolved with 3 months of warfarin). There were two pericardial effusions, both pre-existing and not requiring intervention. Residual leak (patency) was seen in 28/44 (63.6%), and the mechanisms of leak were readily identified by CCTA (off-axis device, gaps at orifice, or fabric leak). Mean follow-up was 1.2 ± 1.1year, with no death, stroke, or systemic embolism. Conclusion CCTA appears to be a feasible alternative to transoesophageal echocardiography for post-LAA device surveillance to evaluate for device thrombus, residual leak, embolization, position, and pericardial effusion. PMID:25851318

  6. 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

  7. Pan-Nitinol Occluder and Special Delivery Device for Closure of Patent Ductus Arteriosus

    PubMed Central

    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. PMID:23466429

  8. Clinical practice, resource utilization, and outcomes of device closure of patent foramen ovale in pediatrics.

    PubMed

    Menon, Shaji C; Grove, Amanda; McFadden, Molly; Korgenski, Kent E; Cowley, Collin G

    2014-03-01

    There are few data on patent foramen ovale closure and its outcome in children. In this study, we evaluated the current clinical practice, resource utilization, and outcome of device closure of patent foramen ovale in children. We hypothesized that patent foramen ovale closure would not result in a demonstrated benefit in children. We undertook a prospective survey of all consecutive patients (<20 years) who underwent patent foramen ovale closure in our metropolitan area between 1995 and 2010. Differences in proportions were tested using the chi-square test or Fisher's exact test where appropriate. Differences in group medians were tested using Wilcoxon signed-rank test. A total of 153 patients (104 girls), median age 16 years (range 7-19) were studied. Indications for patent foramen ovale closure included: (1) migraine headache (104; 68%), (2) nonmigraine headache (24; 16%), (3) visual symptoms (110; 72%), (4) transient ischemic attack symptoms (42; 28%), and (5) stroke-like symptom (24; 16%). Patent foramen ovale was closed with an Amplatzer septal occluder in 115 (75%) and a Helex septal occluder in 47 (30%). The mean length of hospital stay was 18 ± 11 hours; the mean hospital charge was $24,126 ± $5808. The median duration of follow-up was 12 months, and 80 patients responded to the study survey. On follow-up, symptoms improved in 143 (93%), of which 29 (19%) had a residual shunt. None of the patient or treatment parameters predicted lack of improvement on follow-up. Despite the lack of proven benefit, children undergo closure of the patent foramen ovale for a variety of reasons, with the vast majority (92%) of patients reporting significant improvement in their symptoms. However, patent foramen ovale closure is an expensive procedure with serious potential complications. Symptomatic improvement even in the presence of a residual shunt suggests a strong placebo effect. Copyright © 2014 Elsevier Inc. All rights reserved.

  9. Percutaneous atrial shunt closure using the novel Occlutech Figulla device: 6-month efficacy and safety.

    PubMed

    Van Den Branden, Ben J L; Post, Martijn C; Plokker, Herbert W M; Ten Berg, Jurriën M; Suttorp, Maarten J

    2011-06-01

    The Occlutech Figulla Occluder is a new innovative device for percutaneous closure of a patent foramen ovale (PFO) and an atrial septum defect (ASD). We describe the safety and efficacy of this new device at 6-month follow-up. All 82 consecutive patients (51% female, mean age 49.0 ± 13.6 years) who underwent percutaneous PFO (n = 48) or ASD (n = 34) closure between October 2008 and October 2009 were included. Implantation success was 100%. The in-hospital complications were two new onset supraventricular tachycardia (SVT) (2.4%, both ASD patients), nine minimal groin hematoma's (11.0%, 4 PFO and 5 ASD patients), and one transient ST elevation during the procedure (1.2%, ASD patient). During 6 months follow-up (n = 79), no major complications or reoccurrences of cerebral thrombo-embolic events did occur. Seven patients (8.9%, 6 PFO and 1 ASD patient) experienced a new SVT. One patient developed a recurrent cerebral hemorrhage 5 months after ASD closure, which appeared not to be related to the procedure. Using contrast transthoracic echocardiography 6 months after PFO closure (n = 45), a residual shunt was present in 30.2% of the patients (small 25.6%, moderate 4.6%, severe 0%). In the ASD group (n = 34), a residual shunt was observed in 32.5% (small 17.7%, moderate 14.7%, severe 2.9%). The Occlutech Figulla Occluder appears to be easy to use, effective, and safe for percutaneous closure of PFO and ASD. We report a low complication rate but a relative high percentage of small residual shunts 6 months after closure. ©2010, Wiley Periodicals, Inc.

  10. Efficacy and Safety of the Angioseal Vascular Closure Device Post Antegrade Puncture

    SciTech Connect

    Looby, S.; Keeling, A. N.; McErlean, A.; Given, M. F.; Geoghegan, T.; Lee, M. J.

    2008-05-15

    In this study, the efficacy and safety of the Angioseal vascular closure device post antegrade puncture of the common femoral artery (CFA) for lower limb vascular interventional procedures are evaluated. A retrospective analysis of the medical records of 60 consecutive patients who were referred for interventional procedures in the superficial femoral artery (SFA) or popliteal artery (popl. art.) was performed. Antegrade puncture was successfully performed in 58 of 60 patients (96.6%). Indications included right SFA angioplasty (n = 35), left SFA angioplasty (n = 17), right popl. art. angioplasty (n = 5), and left popl. art. angioplasty (n = 1). Hemostasis was achieved by, on an intention-to-treat basis, the Angioseal vascular closure device in 46 patients and manual compression in 12 patients. Manual compression was used instead of Angioseal because of severe calcified arterial wall plaques (n = 7), failed deployment of the Angioseal (n = 4), and left SFA dissection (n = 1). There were no major recorded complications in the Angioseal group despite the use of antiplatelet or anticoagulant medications. Twenty-three (50%) of the patients in the Angioseal group were discharged within 24 h. Thirty-seven of the 46 patients who received an Angioseal device had undergone a previous ipsilateral CFA puncture (time range, 2 days to 56 months; mean, 6.2 months). Nine of these patients had undergone ipsilateral Angioseal deployment in the previous 3 months. We conclude that the Angioseal vascular closure device is a safe and efficient means of achieving hemostasis post antegrade puncture.

  11. Use of a Collagen-Based Device for Closure of Low Brachial Artery Punctures

    SciTech Connect

    Belenky, A. Aranovich, D.; Greif, F.; Bachar, G.; Bartal, G.; Atar, E.

    2007-04-15

    Purpose. To report our experience with the Angioseal vascular closure device for hemostasis of distal brachial artery puncture. Methods. Between September 2003 and August 2005, 64 Angioseal vascular closure devices were inserted in 64 patients (40 men, 24 women; mean age 65 years) immediately after diagnostic or therapeutic arterial angiographies performed through a 5 Fr to 7 Fr sheath via the distal brachial artery. Ultrasound examination of the brachial artery preceded the angiography in all cases and only arteries wider than 4 mm were closed by the Angioseal. In cases of a sonographically evident thin subcutaneous space of the cubital fossa, tissue tumescence, using 1% Lidocaine, was performed prior to the arterial closure. Results. The deployment success rate was 100%. No major complications were encountered; only 2 patients developed puncture site hematoma, and these were followed conservatively. Conclusions. Closure of low brachial artery punctures with the Angioseal is simple and safe. No additional manual compression is required. We recommend its use after brachial artery access interventions, through appropriately wide arteries, to improve early patient ambulation and potentially reduce possible puncture site complications.

  12. Evaluation of a new skin closure device in surgical incisions associated with breast procedures.

    PubMed

    Blondeel, Phillip N; Richter, Dirk; Stoff, Alexander; Exner, Klaus; Jernbeck, Jan; Ramakrishnan, Venkat

    2014-12-01

    A novel topical skin adhesive system was developed to close the outermost layer of skin in an expeditious manner. To determine its clinical utility in breast procedures, a prospective clinical investigation was undertaken to demonstrate equivalence of a new adhesive (PRINEO™ Skin Closure System) to intradermal sutures in wound closure. The investigation comprised 79 patients who underwent elective surgery for bilateral breast procedures. Each breast incision was randomized to wound closure with the PRINEO™ Skin Closure System or intradermal sutures (used in accordance with standard local practice). Postoperative evaluations took place at 24 hours, 7 days, 12-25 days, 90 days, 6 months, and 12 months. Data were collected on the continuous approximation of the skin edges, the time required to close the include final skin layer, the evaluation of incision healing, and cosmesis outcomes. Safety evaluations were related to the incidence and extent of local acute inflammatory reactions, clinical infection, skin blistering, and adverse events. PRINEO™ Skin Closure System was found to be equivalent to intradermal sutures for the continuous approximation of wounds associated with breast procedures. The upper limit of the one-sided 95% confidence interval for difference in proportions was less than the predetermined 12%, at 5.9%. The mean time to closure for the PRINEO™ Skin Closure System was 2.56 minutes, which was 13.66 minutes faster than that for intradermal sutures (16.22 minutes, P < 0.0001). Time savings may be less if 2 operators close simultaneously. On the other hand, because the device can be applied by 1 operator, the assistant's time may be freed up to attend to other tasks. Both treatments had similar incision healing and cosmetic outcomes. No quantitative or qualitative differences of clinical significance were evident between the treatment groups for local acute inflammatory reactions, clinical infection, or skin blistering. The number of serious

  13. A pilot study evaluating laparoscopic closure of the nephrosplenic space using an endoscopic suturing device in standing horses

    PubMed Central

    Bracamonte, José L.; Duke-Novakovski, Tanya

    2016-01-01

    This study evaluated the use of an articulating automated suturing device for laparoscopic closure of the nephrosplenic space in standing horses. Closure of the nephrosplenic space was performed in 4 horses using an automated suturing device. Second-look laparoscopy was performed at 5 weeks. A smooth fibrous adhesion formed between the spleen, the perirenal fascia, and the nephrosplenic ligament in 3 of the 4 horses in which the nephrosplenic space was closed using the automated suturing device. In 1 horse, closure of the nephrosplenic space was not possible due to constant breakage of the endoscopic needle. Intra-operative complications encountered with the automated suturing device were tearing of the perirenal fascia, nephrosplenic ligament, and dorsal splenic capsule along with breakage of the needle. The automated suturing device used in this study for laparoscopic closure of the nephrosplenic space resulted in longer surgery times, suffered instrument failures and delivered inadequate suture. PMID:27247467

  14. A pilot study evaluating laparoscopic closure of the nephrosplenic space using an endoscopic suturing device in standing horses.

    PubMed

    Bracamonte, José L; Duke-Novakovski, Tanya

    2016-06-01

    This study evaluated the use of an articulating automated suturing device for laparoscopic closure of the nephrosplenic space in standing horses. Closure of the nephrosplenic space was performed in 4 horses using an automated suturing device. Second-look laparoscopy was performed at 5 weeks. A smooth fibrous adhesion formed between the spleen, the perirenal fascia, and the nephrosplenic ligament in 3 of the 4 horses in which the nephrosplenic space was closed using the automated suturing device. In 1 horse, closure of the nephrosplenic space was not possible due to constant breakage of the endoscopic needle. Intra-operative complications encountered with the automated suturing device were tearing of the perirenal fascia, nephrosplenic ligament, and dorsal splenic capsule along with breakage of the needle. The automated suturing device used in this study for laparoscopic closure of the nephrosplenic space resulted in longer surgery times, suffered instrument failures and delivered inadequate suture.

  15. 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.

  16. 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.

  17. Internal vacuum-assisted closure device in the swine model of severe liver injury

    PubMed Central

    2012-01-01

    Objectives The authors present a novel approach to nonresectional therapy in major hepatic trauma utilizing intraabdominal perihepatic vacuum assisted closure (VAC) therapy in the porcine model of Grade V liver injury. Methods A Grade V injury was created in the right lobe of the liver in a healthy pig. A Pringle maneuver was applied (4.5 minutes total clamp time) and a vacuum assisted closure device was placed over the injured lobe and connected to suction. The device consisted of a perforated plastic bag placed over the liver, followed by a 15 cm by 15cm VAC sponge covered with a nonperforated plastic bag. The abdomen was closed temporarily. Blood loss, cardiopulmonary parameters and bladder pressures were measured over a one-hour period. The device was then removed and the animal was euthanized. Results Feasibility of device placement was demonstrated by maintenance of adequate vacuum suction pressures and seal. VAC placement presented no major technical challenges. Successful control of ongoing liver hemorrhage was achieved with the VAC. Total blood loss was 625 ml (20ml/kg). This corresponds to class II hemorrhagic shock in humans and compares favorably to previously reported estimated blood losses with similar grade liver injuries in the swine model. No post-injury cardiopulmonary compromise or elevated abdominal compartment pressures were encountered, while hepatic parenchymal perfusion was maintained. Conclusion These data demonstrate the feasibility and utility of a perihepatic negative pressure device for the treatment of hemorrhage from severe liver injury in the porcine model. PMID:23217091

  18. Comparative study of the transcatheter and transthoracic device closure treatments for atrial septal defect: A Chinese single-institution experience.

    PubMed

    Chen, Qiang; Cao, Hua; Chen, Zhao-Yang; Zhang, Gui-Can; Chen, Liang-Wan; Xu, Fan; He, Jia-Jun

    2017-03-01

    The purpose of this study was to compare patient populations, safety, feasibility, complications, and total costs of the transcatheter and transthoracic device closure treatments for secundum atrial septal defect.From January 2014 to December 2014, we enrolled 155 patients with secundum atrial septal defects in our hospital. The patients were divided into 2 groups: the 70 patients in group A underwent transcatheter device closure, and the 85 patients in group B underwent transthoracic intraoperative device closure with a right lateral mini-thoracotomy.In group A, the total occlusion rate was 94.3% immediately after the operation, 100% at 3 months, and 100% at 12 months of follow-up; the group A results were not statistically different from the group B results (94.1%, 98.8%, 98.8%, respectively). There was a statistically significant difference in the minor complication rate (P < 0.05), and there were no reported deaths. There was a greater indicated scope using the transthoracic closure device to treat atrial septal defects. In our comparative study, the patients in group B had longer intensive care unit stays and hospital stays than group A (P < 0.05).Both of the device closure treatment options for secundum atrial septal defect are safe and feasible. The transcatheter device closure approach has the advantages of more cosmetic results, less trauma, and a shorter hospital stay than the transthoracic approach. On the contrary, the transthoracic closure device is an economical alternative choice, particularly for patients who are not eligible for the transcatheter closure device.

  19. StarClose Vascular Closure Device: Prospective Study on 222 Deployments in an Interventional Radiology Practice

    SciTech Connect

    Imam, Atique; Carter, Ranjana M. S. Phillips-Hughes, Jane; Boardman, Philip; Uberoi, Raman

    2007-07-15

    The StarClose device (Abbott Vascular Devices; Abbott Laboratories, Redwood City, CA) utilizes an externally placed Nitinol clip to achieve arterial closure following femoral artery puncture. The objectives of this study were to assess the efficacy and complications of the StarClose device in patients undergoing interventional radiological procedures. Preprocedural clotting status, pulse and blood pressure, severity of vessel calcification, sheath size, and time to deployment were recorded. Postdeployment complications immediately postprocedure, at 1 h, at 2 h, and at 1 week were recorded. A duplex scan was performed in the first 10 patients to assess any immediate vascular complications. Deployments were successful in 96% achieving immediate hemostasis. Mean deployment time was 48 s. There were no major complications. The StarClose device was found to have a high technical and clinical efficacy.

  20. A new device for transcatheter closure of the patent ductus arteriosus. A feasibility study in dogs.

    PubMed

    Magal, C; Wright, K C; Duprat, G; Wallace, S; Gianturco, C

    1989-04-01

    A new device for transcatheter closure of the patent ductus arteriosus was developed and initially evaluated in the vasculature of adult mongrel dogs. The device consists of a nylon sack that can be made in various sizes and shapes. A small flexible crossbar attached to the distal end maintains the position of the sack while it is filled with a segment of modified guide wire. The device is delivered coaxially through a 10-Fr Teflon catheter and is easily repositioned or retrieved before release. The expansile force of the sack against the vessel wall can be varied, and its stability is easily checked prior to detachment. The device produced immediate and permanent vascular occlusion without inflammation or erosion. Over time, the entire unit became incorporated into the vessel wall by neointimal encasement. Nylon sacks offer a simple, unique method of closing virtually any ductus arteriosus without general anesthesia and major surgery.

  1. Cardiac CT angiography for device surveillance after endovascular left atrial appendage closure.

    PubMed

    Saw, Jacqueline; Fahmy, Peter; DeJong, Peggy; Lempereur, Mathieu; Spencer, Ryan; Tsang, Michael; Gin, Kenneth; Jue, John; Mayo, John; McLaughlin, Patrick; Nicolaou, Savvas

    2015-11-01

    Left atrial appendage (LAA) device imaging after endovascular closure is important to assess for device thrombus, residual leak, positioning, surrounding structures, and pericardial effusion. Cardiac CT angiography (CCTA) is well suited to assess these non-invasively. We report our consecutive series of non-valvular atrial fibrillation patients who underwent CCTA post-LAA closure with Amplatzer Cardiac Plug (ACP), Amulet (second generation ACP), or WATCHMAN devices. Patients underwent CCTA typically 1-6 months post-implantation. Prospective cardiac-gated CCTA was performed with Toshiba 320-detector or Siemens 2nd generation 128-slice dual-source scanners, and images interpreted with VitreaWorkstation™. GFR <30 mL/min/1.73 m(2) was an exclusion. We assessed for device thrombus, residual LAA leak, device embolization, position, pericardial effusion, optimal implantation, and device lobe dimensions. Forty-five patients underwent CCTA at median 97 days post-LAA closure (18 ACP, 9 Amulet, 18 WATCHMAN). Average age was 75.5 ± 8.9 years, mean CHADS2 score 3.1 ± 1.3, and CHADS-VASc score 4.9 ± 1.6. All had contraindications to oral anticoagulation. Post-procedure, 41 (91.1%) were discharged on DAPT. There was one device embolization (ACP, successfully retrieved percutaneously) and one thrombus (WATCHMAN, resolved with 3 months of warfarin). There were two pericardial effusions, both pre-existing and not requiring intervention. Residual leak (patency) was seen in 28/44 (63.6%), and the mechanisms of leak were readily identified by CCTA (off-axis device, gaps at orifice, or fabric leak). Mean follow-up was 1.2 ± 1.1year, with no death, stroke, or systemic embolism. CCTA appears to be a feasible alternative to transoesophageal echocardiography for post-LAA device surveillance to evaluate for device thrombus, residual leak, embolization, position, and pericardial effusion. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015

  2. Fluoroscopy-guided snare retrieval of the celt ACD(®) metallic vascular closure device following failed deployment.

    PubMed

    Cahill, Thomas J; Choji, Kiyoshi; Kardos, Attila

    2014-03-01

    We report a case of endovascular snare retrieval of a new stainless steel vascular closure device (Celt ACD(®) , Kimal, Middlesex, UK) from the common femoral artery, following device failure after diagnostic coronary angiography. The stainless steel composition of the device aided successful fluoroscopic localization and removal. Copyright © 2013 Wiley Periodicals, Inc.

  3. 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.

  4. Transcatheter closure of the perimembranous ventricular septal defect-preclinical trial of a new Amplatzer device.

    PubMed

    Bass, John L; Gruenstein, Daniel

    2012-06-01

    This study assessed the feasibility and efficacy of implanting a new nitinol device for closure of perimembranous ventricular septal defects in a swine model. Perimembranous ventricular septal defect occurs in 80% of patients requiring treatment for congenital heart disease. The Amplatzer perimembranous ventricular septal occluder device (pmVSO2 device, AGA Medical Company, Plymouth MN) is a new transcatheter Nitinol device containing polyester fabric designed to close the perimembranous ventricular septal defect (VSD). The device has 75% reduction in radial force, 45% reduction in clamping force, and increased stability as compared to the previous version. The device was implanted in six swine with naturally occurring perimembranous VSD with immediate, 1, 7, ∼30, and ∼90 day followup by echocardiography, angiography, and final pathological examination. The device was successfully implanted in all animals and was retrievable and repositionable. There was complete occlusion of the VSD in five of six cases without embolization. There was no thrombus formation on the device or occurrence of complete heart block. A single instance of a tiny residual shunt was attributed to capture of tricuspid valve apparatus. The success of this animal study confirms safety and feasibility of the Amplatzer pmVSO2 device. Human trials are planned. Copyright © 2011 Wiley Periodicals, Inc.

  5. [Treatment of postoperative ventral hernias with device closure of aponeurotic defect].

    PubMed

    Izmaĭlov, S G; Lazarev, V M; Kapustin, K V

    2003-01-01

    A new method of treatment of postoperative ventral hernias was developed. During surgery under control over intraabdominal pressure hernial defect is closed with special devices for closure of wound margins. Plastic repair with local tissues in the form of duplication with uninterruptedly-recurrent suture (1st variant) or by contact method ("in join") with auto- or alloplasty on suture line (2nd variant) are performed when intraabdominal pressure doesn't change. If intraabdominal pressure increases, closure of the wound is stopped and polypropylene net or autodermal transplant (3rd variant) are sutured to margins of the wound. One hundred and sixty-eight patients with postoperative ventral hernias underwent surgeries with this method. Control group consisted of 110 patients. Recurrence of hernia was seen in 33 (30%) patients. There were no recurrences in the study group after the 2nd and 3rd variant of the surgery. In the 1st variant recurrence was seen in 6% cases. The method is recommended for surgical departments. Device immobilization permits to decrease tension in sutured tissue, creates optimal conditions for wound closure and prevents suture insufficiency.

  6. A comparison of a new skin closure device and intradermal sutures in the closure of full-thickness surgical incisions.

    PubMed

    Richter, Dirk; Stoff, Alexander; Ramakrishnan, Venkat; Exner, Klaus; Jernbeck, Jan; Blondeel, Phillip N

    2012-10-01

    A novel topical skin adhesive system was developed to close the outermost layer of skin in an expeditious manner. To determine its clinical utility, a clinical investigation was undertaken to demonstrate equivalence of a new adhesive skin closure system (Prineo Skin Closure System) to intradermal sutures in wound closure. The investigation included 83 patients who underwent elective abdominoplasty, circumferential body lift procedures, and breast reconstruction with deep inferior epigastric perforator flaps. Incisions were divided in half, and each half was randomized to wound closure with the new skin closure system, including a pressure-sensitive adhesive mesh tape for wound edge approximation and next-generation cyanoacrylate or intradermal sutures. Postoperative evaluations took place at 24 hours, 7 days, 12 to 25 days, 90 days, 6 months, and 12 months. The new skin closure system was found to be equivalent to intradermal sutures for the continuous approximation of wounds. The upper limit of the two-sided 90 percent confidence interval for difference in proportions was 10.9 percent. The mean time to closure for the new skin closure system was 1.46 minutes, approximately 5 minutes faster than that for intradermal sutures (p < 0.0001). Both treatments had similar incision healing and cosmetic outcomes. No quantitative or qualitative differences of clinical significance were evident between the treatment groups. The Prineo Skin Closure System can be considered equivalent to intradermal sutures for full-thickness surgical incisions with regard to safety and effectiveness. The ease and speed of application contribute to shortened operative times (4.5 times faster than intradermal sutures).

  7. Design and Rationale of the Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) Study

    PubMed Central

    Behnes, Michael; Ünsal, Melike; Hoffmann, Ursula; Fastner, Christian; El-Battrawy, Ibrahim; Lang, Siegfried; Mashayekhi, Kambis; Lehmann, Ralf; Borggrefe, Martin; Akin, Ibrahim

    2015-01-01

    BACKGROUND Bleeding events after percutaneous coronary interventions (PCI) are associated with patients’ age, gender, and the presence of chronic kidney disease, antithrombotic treatment, as well as arterial access site. Patients being treated by PCI using radial access site are associated with an improved prognosis. However, the safety of femoral closure devices has never been compared to radial compression devices following PCI. Therefore, the aim of this study is to evaluate the safety of femoral closure compared to radial compression devices in patients treated by PCI envisaging access site bleedings as well as short- and long-term prognostic outcomes. METHODS The Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) study is a single-center observational study comparing 400 consecutive patients undergoing PCI either using radial compression devices (TR Band™) or femoral closure devices (Angio-Seal™) at the corresponding access site. The primary outcome consists of the occurrence of vascular complications at the arterial access site, including major bleedings as defined by common classification systems. Secondary outcomes consist of the occurrence of adverse cardiac events, including all-cause mortality, target lesion revascularization, and target vessel revascularization during 30 days and 12 months of follow-up. RESULTS Study enrollment was initiated in February 2014. The enrollment phase is expected to last until May 2015. CONCLUSIONS The FERARI study intends to comparatively evaluate the safety and prognostic outcome of patients being treated by radial or femoral arterial closure devices following PCI during daily clinical practice. PMID:26568686

  8. Successful device closure of a post-infarction ventricular septal defect

    PubMed Central

    Choi, Si-Wan; Han, Ji Hye; Jin, Seon-Ah; Kim, Mijoo; Lee, Jae-Hwan; Jeong, Jin-Ok

    2016-01-01

    Ventricular septal defect (VSD) is a lethal complication of myocardial infarction. The event occurs 2–8 days after an infarction and patients should undergo emergency surgical treatment. We report on successful device closure of post-infarction VSD. A previously healthy 66-year-old male was admitted with aggravated dyspnea. Echocardiography showed moderate left ventricular (LV) systolic dysfunction with akinesia of the left anterior descending (LAD) territory and muscular VSD size approximately 2 cm. Coronary angiography showed mid-LAD total occlusion without collaterals. Without percutaneous coronary intervention due to time delay, VSD repair was performed. However, a murmur was heard again and pulmonary edema was not controlled 3 days after the operation. Echocardiography showed remnant VSD, and medical treatment failed. Percutaneous treatment using a septal occluder device was decided on. After the procedure, heart failure was controlled and the patient was discharged without complications. This is the first report on device closure of post-infarction VSD in Korea. PMID:27462148

  9. Use of Amplatzer occlusion devices to occlude Fontan baffle leaks during fenestration closure procedures.

    PubMed

    Crowley, David I; Donnelly, Jon P

    2008-02-01

    The authors describe the use of Amplatzer occlusion devices to successfully occlude Fontan baffle leaks in three patients. These additional right to left shunts were recognized at the time of elective transcatheter closure of surgically created fenestrations. A common site of baffle leak is described at the base of the right atrial appendage. This suture line serves to exclude the right atrial appendage from Fontan baffle flow and lies within the corrugated surface of the pectinate muscles, making it particularly vunerable to baffle leaks over time. Copyright 2008 Wiley-Liss, Inc.

  10. 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.

  11. Left atrial appendage closure: patient, device and post-procedure drug selection.

    PubMed

    Tzikas, Apostolos; Bergmann, Martin W

    2016-05-17

    Left atrial appendage closure (LAAC), a device-based therapy for stroke prevention in patients with atrial fibrillation, is considered an alternative to oral anticoagulation therapy, particularly for patients at high risk of bleeding. Proof of concept has been demonstrated by the PROTECT AF and PREVAIL trials which evaluated the WATCHMAN device (Boston Scientific, Marlborough, MA, USA) versus warfarin, showing favourable outcome for the device group. The most commonly used devices for LAAC are the WATCHMAN and its successor, the WATCHMAN FLX (Boston Scientific) and the AMPLATZER Cardiac Plug and more recently the AMPLATZER Amulet device (both St. Jude Medical, St. Paul, MN, USA). The procedure is typically performed via a transseptal puncture under fluoroscopic and echocardiographic guidance. Technically, it is considered quite demanding due to the anatomic variability and fragility of the appendage. Careful material manipulation, adequate operator training, and good cardiac imaging and device sizing allow a safe, uneventful procedure. Post-procedure antithrombotic drug selection is based on the patient's history, indication and quality of LAAC.

  12. [Successful treatment of Candida albicans mediastinitis after open-heart surgery using vacuum-assisted closure device].

    PubMed

    Fukunaga, Naoto; Nishiya, Kenta; Sakon, Yoshito; Konishi, Yasunobu; Nakamura, Ken; Saji, Yoshiaki; Kanemitsu, Hideo; Koyama, Tadaaki

    2014-10-01

    An 82-year-old man suffered from Candida albicans mediastinitis following emergency aortic valve replacement. After repeated debridement of the anterior portion of the mediastinum, we applied a vacuum assisted closure device with UrgoTul Absorb placed on the right ventricle. Despite relatively short-term application of this device, mediastinitis was cured in combination with transposition of the great omentum.

  13. 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.

  14. Bailout transcatheter closure of patent foramen ovale for refractory hypoxaemia after left ventricular assist device implantation.

    PubMed

    Fischer, Quentin; Kirsch, Matthias; Brochet, Eric; Juliard, Jean-Michel

    2015-08-01

    We describe the interdisciplinary management of a 59-year old man with ischaemic cardiomyopathy on a HeartMate II left ventricular assist device (LVAD) and temporary right extracorporeal membrane oxygenation (ECMO) as a bridge-to-heart transplantation. He suffered refractory hypoxaemia due to massive right-to-left shunting by a patent foramen ovale (PFO), diagnosed after weaning off of temporary right ECMO. Percutaneous closure of the PFO was successfully achieved with an Amplatzer septal occluder device, which allowed the patient's extubation and departure from hospital. The patient received heart transplantation 7 weeks after LVAD implantation and was discharged from the intensive care unit 2 weeks after transplantation. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  15. Transcatheter closure of patent ductus arteriosus: experience with a new device.

    PubMed

    Agnetti, Aldo; Aldo, Agnetti; Carano, Nicola; Nicola, Carano; Tchana, Bertrand; Bertrand, Tchana; Allegri, Valentina; Valentina, Allegri; Saracino, Antonio; Antonio, Saracino; Squarcia, Umberto; Umberto, Squarcia; Hagler, Donald J; Donald J, Hagler

    2009-11-01

    Transcatheter closure is the preferred method of treatment of patent ductus arteriosus (PDA). Detachable coils are widely used to close small ducts, while the Amplatzer duct occluder (ADO) is generally employed for moderate or large ducts. Recently a new device, the Amplatzer duct occluder II (ADO II), a nitinol flexible mesh, with a symmetrical design to provide high conformability for treatment of all types of PDA, has received the European Community mark approval. We report on one of the first experience, four cases (1 male, 3 female, age ranging from six months to seven years old) with different type and size of PDA treated with the new device. The use of this new Amplatzer duct occluder in our experience has the advantage of ease and safety of placement, conformability, stability, low profile catheters, adaptability for long ducts as in type E.

  16. Device closure of post-myocardial infarction ventricular septal defect three weeks after coronary angioplasty

    PubMed Central

    Patnaik, A. N.; Barik, Ramachandra; Kumari, N. Rama; Gulati, A. S.

    2012-01-01

    Percutaneus device closure appears to be safe and effective in patients treated for a residual shunt after initial surgical closure, as well as after two to three weeks of index myocardial infarction. The index case presented with a ventricular septal defect on second of acute myocardial infarction thrombolysed with streptokinase. The general condition of the patient was fairly stable. Cardiac catheterization and coronary angiography showed significant left to right shunt and there was 90 % proximal stenosis of left anterior descending coronary artery. Other coronary arteries were normal. Angioplasty and stenting to the coronary artery lesion was done using drug eluting stent (DES) with very good angiographic result. Patient was discharged after four days in stable condtion. After 3 weeks his ventricular septal defect was closed percutaneusly using cardio -O-fix device with tiny residual shunt. The procedure was uneventful and of brief duration. He was discharged after 5 days of the post procedure in very stable condition with minimal residual shunt. A staged procedure is a better option if the condition of the patient allows strengthening ventricular septal defect border. PMID:22629038

  17. Peratrial Device Closure of Atrial Septal Defect Under Transesophageal Echocardiographic Guidance without Fluoroscopy Compared to Conventional On-Pump Surgical Closure

    PubMed Central

    Guo, Zhixiang; Zhang, Chengxin; Wang, Huan; Ge, Shenglin

    2017-01-01

    Objective This study is designed to evaluate the advantages between peratrial device closure under transesophageal echocardiographic guidance and open heart surgery in atrial septal defect. Methods From November 2011 to September 2014, 28 patients with atrial septal defect were treated. Fourteen patients received peratrial device closure under transesophageal echocardiographic guidance (TEE group) and 14 patients received cardiopulmonary bypass (CPB group). Clinical parameters during intraoperative and postoperative periods were examined. Results All patients recovered after surgery without serious complications. Compared with that in CPB group, clinical observations in TEE group showed significant decreases in the operation time (193.6±35.5 vs. 77.4±22.7 min, P<0.05), periods in intensive care unit (31.6±23.3 vs. 17.5±8.1 hours, P<0.05), fluid volume after operation (502.5±439.3 vs. 32.5±7.3 ml, P<0.05), postoperative length of hospital stay (8.9±2.8 vs. 6.8±2.4 days, P<0.05) and total hospitalization cost (7205.9±1617.6 vs. 5882.3±441.2 $, P<0.05). Conclusion The peratrial device closure of atrial septal defect under transesophageal echocardiographic guidance is a mini-invasive, simple, safe and effective intervention. Its use in the clinical practice should be encouraged.

  18. The BioSTAR(r) device versus the CardioSEAL(r) device in patent foramen ovale closure: comparison of mid-term efficacy and safety.

    PubMed

    Van den Branden, Ben J; Luermans, Justin G; Post, Martijn C; Plokker, Herbert W; Ten Berg, Jurriën M; Suttorp, Maarten J

    2010-09-01

    To compare the mid-term efficacy and safety of the bioabsorbable BioSTAR(r) device with the non-bioabsorbable CardioSEAL(r) device for percutaneous patent foramen ovale (PFO) closure. All 81 consecutive patients who underwent PFO closure with the CardioSEAL(r) or BioSTAR(r) device between June 2003 and July 2008 were included. The presence of a residual shunt (minimal, moderate or large) was measured in both groups at six months follow-up, using contrast transthoracic echocardiography. Forty-four patients (48.4±11.4 years) received the CardioSEAL(r) device and 37 patients the BioSTAR(r) device (47.9±10.7 years). There were no significant differences in short-term complications. Two patients who received the BioSTAR(r) device developed a recurrent transient cerebral ischaemic event. Overall, atrial arrhythmias occurred in 19%, with no difference between both groups. At six months, a residual shunt was present in 29% (27% minimal, 2% moderate) using the CardioSEAL(r) device compared to 28% (17% minimal, 11% moderate) using the BioSTAR(r) device (p=0.18). A predictor for residual shunt could not be found. There is no difference in safety and efficacy at six months between the CardioSEAL(r) and BioSTAR(r) device used for PFO closure. However, using the BioSTAR(r) device tends to be associated with a higher percentage of moderate shunting.

  19. Subatmospheric pressure wound therapy and the vacuum-assisted closure device: basic science and current clinical successes.

    PubMed

    Plikaitis, Christina M; Molnar, Joseph A

    2006-03-01

    This article reviews the development, current theories behind the mechanism of action and clinical use of subatmospheric pressure wound therapy with the vacuum-assisted closure device. An evolving list of indications for subatmospheric pressure therapy is discussed including its use in chronic wounds, traumatic wounds and orthopedic salvage, infected sternal wounds, management of the open abdomen, enterocutaneous fistulae, burn wounds, skin grafts and dermal substitutes, as well as systemic disease processes, such as myoglobinuria. The vacuum-assisted closure device Instill system is also reviewed, in which subatmospheric pressure therapy has been combined with the instillation of therapeutic solutions for the treatment of difficult infected wounds.

  20. Left Atrial Appendage Closure Device With Delivery System: A Health Technology Assessment

    PubMed Central

    Nevis, Immaculate; Falk, Lindsey; Wells, David; Higgins, Caroline

    2017-01-01

    Background Atrial fibrillation is a common cardiac arrhythmia, and 15% to 20% of those who have experienced stroke have atrial fibrillation. Treatment options to prevent stroke in people with atrial fibrillation include pharmacological agents such as novel oral anticoagulants or nonpharmacological devices such as the left atrial appendage closure device with delivery system (LAAC device). The objectives of this health technology assessment were to assess the clinical effectiveness and cost-effectiveness of the LAAC device versus novel oral anticoagulants in patients without contraindications to oral anticoagulants and versus antiplatelet agents in patients with contraindications to oral anticoagulants. Methods We performed a systematic review and network meta-analysis. We also conducted an economic literature review, economic evaluation, and budget impact analysis to assess the cost-effectiveness and budget impact of the LAAC device compared with novel oral anticoagulants and oral antiplatelet agents (e.g., aspirin). We also spoke with patients to better understand their preferences, perspectives, and values. Results Seven randomized controlled studies met the inclusion criteria for indirect comparison. Five studies assessed the effectiveness of novel oral anticoagulants versus warfarin, and two studies compared the LAAC device with warfarin. No studies were identified that compared the LAAC device with aspirin in patients in whom oral anticoagulants were contraindicated. Using the random effects model, we found that the LAAC device was comparable to novel oral anticoagulants in reducing stroke (odds ratio [OR] 0.85; credible interval [Cr.I] 0.63–1.05). Similarly, the reduction in the risk of all-cause mortality was comparable between the LAAC device and novel oral anticoagulants (OR 0.71; Cr.I 0.49–1.22). The LAAC device was found to be superior to novel oral anticoagulants in preventing hemorrhagic stroke (OR 0.45; Cr.I 0.29–0.79), whereas novel oral

  1. Perventricular device closure of residual muscular ventricular septal defects after repair of complex congenital heart defects in pediatric patients.

    PubMed

    Zhu, Da; Tao, Kaiyu; An, Qi; Luo, Shuhua; Gan, Changping; Lin, Ke

    2013-01-01

    Residual muscular ventricular septal defects are surgical challenges, especially after the repair of complex congenital heart defects. We investigated perventricular device closure as a salvage technique in pediatric patients who had postoperative residual muscular ventricular septal defects. From February 2009 through June 2011, 14 pediatric patients at our hospital had residual muscular ventricular septal defects after undergoing surgical repair of complex congenital heart defects. Ten patients met our criteria for perventricular device closure of the residual defects: significant left-to-right shunting (Qp/Qs >1.5) or substantial hemodynamic instability (a defect ≥2 mm in size). The patients' mean age was 20.4 ± 13.5 months, and their mean body weight was 10 ± 3.1 kg. The median diameter of the residual defects was 4.2 mm (range, 2.5-5.1 mm). We deployed a total of 11 SQFDQ-II Muscular VSD Occluders (Shanghai Shape Memory Alloy Co., Ltd.; Shanghai, China) in the 10 patients, in accord with conventional techniques of perventricular device closure. The mean procedural duration was 31.1 ±9.1 min. We recorded the closure and complication rates perioperatively and during a 12-month follow-up period. Complete closure was achieved in 8 patients; 2 patients had persistent trivial residual shunts. No deaths, conduction block, device embolism, or other complications occurred throughout the study period. We conclude that perventricular device closure is a safe, effective salvage treatment for postoperative residual muscular ventricular septal defects in pediatric patients. Long-term studies with larger cohorts might further confirm this method's feasibility.

  2. Single clips versus multi-firing clip device for closure of mucosal incisions after peroral endoscopic myotomy (POEM)

    PubMed Central

    Verlaan, Tessa; Ponds, Fraukje A. M.; Bastiaansen, Barbara A. J.; Bredenoord, Albert J.; Fockens, Paul

    2016-01-01

    Background and aims: After Peroral Endoscopic Myotomy (POEM), the mucosal incision is closed with endoscopically applied clips. After each clip placement, a subsequent clipping device has to be introduced through the working channel. With the Clipmaster3, three consecutive clips can be placed without reloading which could reduce closure time. We performed a prospective study evaluating efficacy, safety, and ease of use. Closure using Clipmaster3 was compared to closure with standard clips. Methods: Patients undergoing closure with the Clipmaster3 were compared to patients who underwent POEM with standard clip closure. Results: In total, 12 consecutive POEM closures with Clipmaster3 were compared to 24 standard POEM procedures. The Clipmaster3 and the standard group did not differ in sex distribution, age (42 years [29 – 49] vs 41 years [34 – 54] P = 0.379), achalasia subtype, disease duration, length of the mucosal incision (25.0 mm [20 – 30] vs 20.0 mm [20 – 30], P = 1.0), and closure time (622 seconds [438 – 909] vs 599 seconds [488 – 664] P = 0.72). Endoscopically successful closure could be performed in all patients. The proportion of all clips used that were either displaced or discarded was larger for Clipmaster3 (8.8 %) compared to standard closure (2.0 %, P  = 0.00782). Ease of handling VAS (visual analogue scale) score for Clipmaster3 did not differ between endoscopist and endoscopy nurse (7 out of 10). Conclusions: Clipmaster3 is feasible and safe for closure of mucosal incisions after POEM. Clipmaster3 was not associated with reduced closure time. Compared to standard closure, more Clipmaster3 clips were displaced or discarded to achieve successful closure. A training effect cannot be excluded as a cause of these results. Study registration: NCT01405417 PMID:27747277

  3. Percutaneous left atrial appendage closure devices: safety, efficacy, and clinical utility

    PubMed Central

    Swaans, Martin J; Wintgens, Lisette IS; Alipour, Arash; Rensing, Benno JWM; Boersma, Lucas VA

    2016-01-01

    Atrial fibrillation (AF) is the most common arrhythmia treated in the clinical practice. One of the major complications of AF is a thromboembolic cerebral ischemic event. Up to 20% of all strokes are caused by AF. Thromboembolic cerebral ischemic event in patients with AF occurs due to atrial thrombi, mainly from the left atrial appendage (LAA). Prevention of clot formation with antiplatelet agents and especially oral anticoagulants (vitamin K antagonists or newer oral anticoagulants) has been shown to be effective in reducing the stroke risk in patients with AF but has several drawbacks with (major) bleedings as the most important disadvantage. Therefore, physical elimination of the LAA, which excludes the site of clot formation by surgical or percutaneous techniques, might be a good alternative. In this review, we discuss the safety, efficacy, and clinical utility of the Watchman™ LAA closure device. PMID:27621674

  4. Short-Term and Midterm Follow-Up of Transthoracic Device Closure of Atrial Septal Defect in Infants.

    PubMed

    Chen, Qiang; Cao, Hua; Zhang, Gui-Can; Chen, Liang-Wan; Xu, Fan; Zhang, Jia-Xin

    2017-06-01

    The purpose of this study was to outline the safety and feasibility of transthoracic device closure of an atrial septal defect (ASD) with a domestic occluder in infants. Sixty-eight infants underwent transthoracic device closure of an ASD at Union Hospital, Fujian Medical University, Fuzhou, China from January 2010 to January 2015. All relevant clinical data were recorded and analyzed. All patients were invited to undergo contrast transthoracic echocardiography for 12 to 60 months after ASD closure, and telephone interviews were conducted with the infants' parents to evaluate the patients' clinical status further. All patients had successful ASD occlusion using this approach. The most frequent complication was transient cardiac arrhythmia, which was easily treated or automatically recovered during the perioperative period. During the follow-up period, no recurrence, thrombosis, device embolization, valve damage, device failure, or death was reported. The total occlusion rate was 100% in the 12 months of follow-up, and all patients showed significant improvement in their clinical status. From transthoracic echocardiographic data, intracardiac structure and cardiac function were significantly improved at follow-up. Transthoracic device closure of an ASD with a domestic occluder in infants is a safe and feasible technique. The short- and medium-term follow-up results were satisfactory, but long-term follow-up is required to assess the safety and feasibility of this method in infants more accurately. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  5. Left atrial appendage closure using the Amulet device: an initial experience with the second generation amplatzer cardiac plug.

    PubMed

    Lam, Simon Cheung Chi; Bertog, Stefan; Gafoor, Sameer; Vaskelyte, Laura; Boehm, Patrick; Ho, Raymond Wei Jian; Franke, Jennifer; Hofmann, Ilona; Sievert, Horst

    2015-02-01

    Aim of this study was to demonstrate the feasibility, safety, and short-term outcome of left atrial appendage (LAA) closure with a new generation LAA closure device. The Amulet device (AGA, St Jude Medical, Minneapolis, MN) is a new generation of the amplatzer cardiac plug (ACP), specifically designed for LAA closure. This new version is designed to facilitate the implantation process and minimize procedural or device-related complications. The device was implanted in 17 patients with nonvalvular atrial fibrillation (AF). Clinical data were obtained at baseline, during the procedure, at discharge, at 30 and 90 days. All devices were implanted successfully. Device sizes ranged from 20 mm to 31 mm. A 12 French (Fr) or 14 Fr delivery sheath was used depending on the selected device size. Full and partial recapture was performed in 1 case and 3 cases, respectively. There was 1 procedure-related pericardial effusion successfully managed with pericardiocentesis. There was no device embolization. The mean length of stay was 2.1 ± 0.3 days. At 90 days, there were no deaths, strokes, systemic thromboembolism, or bleeding complications. There was no device-related thrombus or pericardial effusion at 90-day TEE. In 2 of the 17 patients minimal peridevice flow (smaller than 2 mm) was present. The Amulet device, which has new novel features as compared with the first generation ACP, is a feasible option for LAA closure. From our initial experience, implantation of the Amulet is associated with high success rate and good short-term outcome. © 2014 Wiley Periodicals, Inc.

  6. Extending the limits of transcatheter closure of atrial septal defects with the double umbrella device (CardioSEAL)

    PubMed Central

    Kaulitz, R; Paul, T; Hausdorf, G

    1998-01-01

    Objective—To report initial findings from a selected group of patients with morphological variations of the atrial septal defect who underwent transcatheter closure with a second generation redesigned double umbrella device.
Patients—Two patients with abnormal location of the oval fossa and partial deficiency of the septal rim, three patients with multiple defects, and two patients with a multiperforated aneurysm of the interatrial septum (age range, 3.6-25.5 years).
Methods—Defects were closed with the double umbrella device (CardioSEAL) consisting of two sets of flexible arms (with central and two mid-arm hinges) covered with sewn Dacron patches. The implantation procedure was monitored by transoesophageal echocardiography.
Results—The diameter of the defect measured during transoesophageal echocardiography ranged from 7-18 mm and the balloon stretched diameter ranged from 13-21 mm. The size of the devices varied from 28-33 mm and the ratio of device size to defect size varied from 1.6-2.1. Two devices (23 and 28 mm) were chosen in a patient with two separated defects. No complications or serious arrhythmias were observed during implantation or follow up (median, 1.8 months). Residual shunting was trivial in three patients and mild in one patient (inferiorly located additional defect).
Conclusions—To extend the selection critera of an isolated central interatrial defect for transcatheter closure, some modifications of the implantation technique are needed. Using the redesigned double umbrella device, effective closure in patients with multiple or irregularly shaped atrial septal defects was achieved, indicating a broadening of the spectrum of transcatheter closure.

 Keywords: atrial septal defects;  transcatheter closure;  congenital heart disorders;  double umbrella device;  CardioSEAL PMID:9764060

  7. A new cable-tie-based sternal closure device: infectious considerations†

    PubMed Central

    Melly, Ludovic; Gahl, Brigitta; Meinke, Ruth; Rueter, Florian; Matt, Peter; Reuthebuch, Oliver; Eckstein, Friedrich S.; Grapow, Martin T.R.

    2013-01-01

    OBJECTIVES To determine the difference in sternal infection and other infectious events between conventional wire and cable-tie-based closure techniques post-sternotomy in a collective of patients after cardiac surgery. METHODS The sternal ZipFix™ (ZF) system consists of a biocompatible poly-ether-ether-ketone (PEEK) cable-tie that surrounds the sternum through the intercostal space and provides a large implant-to-bone contact. Between 1 February 2011 and 31 January 2012, 680 cardiac operations were performed via sternotomy at our institution. After the exclusion of operations for active endocarditis and early mortality within 7 days, 95 patients were exclusively closed with ZF and could be compared with 498 who were closed with conventional wires (CWs) during the same period. A multivariable logistic regression analysis, including body mass index, renal impairment and emergency as suspected confounders and inverse propensity weights was performed on the infection rate. RESULTS Total infection rate was 6.1%, with a total of 36 diagnosed sternal infections (5 in ZF and 31 in CW). Comparing ZF with CW with regard to sternal infection, there is no statistically significant difference related to the device (odds ratio: 0.067, confidence interval: 0.04–9.16, P = 0.72). The propensity modelling provided excellent overlap and the mean propensity was almost the same in both groups. Thus, we have observed no difference in receiving either ZF or CW. No sternal instability was observed with the ZF device, unlike 4/31 patients in the CW group. The overall operation time is reduced by 11 min in the ZF group with identical perfusion and clamping times. CONCLUSIONS Our study underlines a neutral effect of the sternal ZipFix™ system in patients regarding sternal infection. Postoperative complications are similar in both sternal closure methods. The cable-tie-based system is fast, easy to use, reliable and safe. PMID:23624983

  8. Using Vascular Closure Devices Following Out-Of-Hospital Cardiac Arrest?

    PubMed Central

    Christ, Martin; von Auenmueller, Katharina Isabel; Liebeton, Jeanette; Grett, Martin; Dierschke, Wolfgang; Noelke, Jan Peter; Breker, Irini Maria; Trappe, Hans-Joachim

    2015-01-01

    Objectives and Background: Despite a generally broad use of vascular closure devices (VCDs), it remains unclear whether they can also be used in victims from out-of-hospital cardiac arrest (OHCA) treated with mild therapeutic hypothermia (MTH). Methods: All victims from OHCA who received immediate coronary angiography after OHCA between January 1st 2008 and December 31st 2013 were included in this study. The operator decided to either use a VCD (Angio-Seal™) or manual compression for femoral artery puncture. The decision to induce MTH was based on the clinical circumstances. Results: 76 patients were included in this study, 46 (60.5%) men and 30 (39.5%) women with a mean age of 64.2 ± 12.8 years. VCDs were used in 26 patients (34.2%), and 48 patients (63.2%) were treated with MTH. While there were significantly more overall vascular complications in the group of patients treated with MTH (12.5% versus 0.0%; p=0.05), vascular complications were similar between patients with VCD or manual compression, regardless of whether or not they were treated with MTH. Conclusion: In our study, the overall rate of vascular complications related to coronary angiography was higher in patients treated with mild therapeutic hypothermia, but was not affected by the application of a vascular closure device. Therefore, our data suggest that the use of VCDs in victims from OHCA might be feasible and safe in patients treated with MTH as well, at least if the decision to use them is individually carefully determined. PMID:25897291

  9. Mechanisms and clinical applications of the vacuum-assisted closure (VAC) Device: a review.

    PubMed

    Venturi, Mark L; Attinger, Christopher E; Mesbahi, Ali N; Hess, Christopher L; Graw, Katherine S

    2005-01-01

    The use of sub-atmospheric pressure dressings, available commercially as the vacuum-assisted closure (VAC) device, has been shown to be an effective way to accelerate healing of various wounds. The optimal sub-atmospheric pressure for wound healing appears to be approximately 125 mm Hg utilizing an alternating pressure cycle of 5 minutes of suction followed by 2 minutes off suction. Animal studies have demonstrated that this technique optimizes blood flow, decreases local tissue edema, and removes excessive fluid from the wound bed. These physiologic changes facilitate the removal of bacteria from the wound. Additionally, the cyclical application of sub-atmospheric pressure alters the cytoskeleton of the cells in the wound bed, triggering a cascade of intracellular signals that increases the rate of cell division and subsequent formation of granulation tissue. The combination of these mechanisms makes the VAC device an extremely versatile tool in the armamentarium of wound healing. This is evident in the VAC device's wide range of clinical applications, including treatment of infected surgical wounds, traumatic wounds, pressure ulcers, wounds with exposed bone and hardware, diabetic foot ulcers, and venous stasis ulcers. VAC has also proven useful in reconstruction of wounds by allowing elective planning of the definitive reconstructive surgery without jeopardizing the wound or outcome. Furthermore, VAC has significantly increased the skin graft success rate when used as a bolster over the freshly skin-grafted wound. VAC is generally well tolerated and, with few contraindications or complications, is fast becoming a mainstay of current wound care.

  10. The immediate use of a silicone sheet wound closure device in scar reduction and prevention.

    PubMed

    Parry, James R; Stupak, Howard D; Johnson, Calvin M

    2016-02-01

    Silicone has been used successfully postoperatively in the prevention of hypertrophic and other types of adverse scars. The Silicone Suture Plate (SSP) is a new, minimally invasive, sterile wound closure device that is applied intraoperatively to prevent adverse scarring. The SSP device permits immediate application of silicone while concurrently allowing for wound-edge tension redistribution. In this prospective, controlled, single-blinded clinical study, 8 consecutive patients undergoing deep-plane rhytidectomy were selected. SSP devices were placed on the patients' posterior rhytidectomy hairline incision; the mirror-image control site underwent standard suturing techniques. Three blinded, independent raters assessed the treatment and control sides at 6-week and 4-month follow-up visits, using the Objective Scar Assessment Scale (OSAS), a validated scar assessment tool. The 6-week OSAS scores revealed an 18.4% improvement on the side with the SSP device (13.3) when compared to the control side (16.3). The 4-month OSAS scores showed a 27.3% improvement on the treatment side from 12.7 (control) to 9.2 (SSP). These OSAS results were found to be statistically significant when taken as an aggregate of the observers' scores, but not when observers' scores were measured individually (p < 0.05). In our series of patients, we showed promising results with the use of the SSP device. Early silicone application and tissue tension distribution contributed to an overall more aesthetically pleasing scar compared to those seen with standard suturing techniques, although more testing is required.

  11. Transcatheter closure of ventricular septal defects using the Amplatzer Duct Occluder II device: a single-center experience

    PubMed Central

    Türkmen, Esma

    2016-01-01

    Introduction Off-label use of different devices has been described for percutaneous closure of ventricular septal defects (VSD) because of the unacceptable rate of post-procedure heart block associated with special VSD devices. Aim To describe the early single-center clinical experience with closure of a VSD using the Amplatzer Duct Occluder II (ADO II) device in children. Material and methods Between May 2013 and June 2015, 26 patients between 13 days and 16 years of age underwent percutaneous closure of a VSD with an ADO II device at our institute. The decision to use the ADO II device was based primarily on lower risk of total atrioventricular block (TAVB) after VSD closure reported in the literature, reduction of the cost of the procedure and the need to close symptomatic VSDs in young patients. Results The location of the VSD was perimembranous in 21 patients, postsurgical residual in 2, midmuscular in 2 and apical muscular in 1. Complex procedures including newborn, combined procedures and postsurgical residual VSD were performed in 5 (19%) patients. The median duration of follow-up was 12 months. The complete VSD closure rate was 81% immediately after the procedure, 85% at 24 h, and 93% at the last follow-up. There was no device embolization. During the entire follow-up period, TAVB did not develop. Conclusions The ADO II constitutes a safe and effective therapeutic alternative for morphologically varied VSDs in all pediatric age groups. A larger range of sizes and configurations of this occluder may be required to successfully occlude a wider range of VSDs. PMID:27980548

  12. Predictors of Early (1-Week) Outcomes Following Left Atrial Appendage Closure With Amplatzer Devices.

    PubMed

    Koskinas, Konstantinos C; Shakir, Samera; Fankhauser, Máté; Nietlispach, Fabian; Attinger-Toller, Adrian; Moschovitis, Aris; Wenaweser, Peter; Pilgrim, Thomas; Stortecky, Stefan; Praz, Fabien; Räber, Lorenz; Windecker, Stephan; Meier, Bernhard; Gloekler, Steffen

    2016-07-11

    The aim of this study was to assess predictors of adverse 1-week outcomes and determine the effect of left atrial appendage (LAA) morphology following LAA closure (LAAC) with Amplatzer devices. Percutaneous LAAC is a valuable treatment option for stroke prevention in patients with atrial fibrillation. Determinants of procedural safety events with Amplatzer occluders are not well established, and the possibly interrelating effect of LAA anatomy is unknown. Between 2009 and 2014, 500 consecutive patients with atrial fibrillation ineligible or at high risk for oral anticoagulation underwent LAAC using Amplatzer devices. Procedure- and device-related major adverse events (MAEs) were defined as the composite of death, stroke, major or life-threatening bleeding, serious pericardial effusion, device embolization, major access-site vascular complication, or need for cardiovascular surgery within 7 days following the intervention. Patients (mean age 73.9 ± 10.1 years) were treated with Amplatzer Cardiac Plug (n = 408 [82%]) or Amulet (n = 92 [18%]) devices. Early procedural success was 97.8%, and MAEs occurred in 29 patients (5.8%). Independent predictors of MAEs included device repositioning (odds ratio: 9.13; 95% confidence interval: 2.85 to 33.54; p < 0.001) and left ventricular ejection fraction <30% (odds ratio: 4.08; 95% confidence interval: 1.49 to 11.20; p = 0.006), with no effect of device type or size. Angiographic LAA morphology, characterized as cauliflower (33%), cactus (32%), windsock (20%), or chicken wing (15%), was not associated with procedural success (p = 0.51) or the occurrence of MAEs (p = 0.78). In this nonrandomized study, procedural success of LAAC using Amplatzer devices was high. MAEs within 7 days were predicted by patient- and procedure-related factors. Although LAA morphology displayed substantial heterogeneity, outcomes were comparable across the spectrum of LAA anatomies. Copyright © 2016 American College of Cardiology Foundation

  13. Prediction of early-onset atrial tachyarrhythmia after successful trans-catheter device closure of atrial septal defect

    PubMed Central

    Park, Kyoung-Min; Hwang, Jin Kyung; Chun, Kwang Jin; Park, Seung-Jung; On, Young Keun; Kim, June Soo; Park, Seung Woo; Kang, I-Seok; Song, Jinyoung; Huh, June

    2016-01-01

    Abstract Atrial tachyarrhythmia is a well-known long-term complication of atrial septal defect (ASD) in adults, even after successful trans-catheter closure. However, the risk factors for early-onset atrial tachyarrhythmia after trans-catheter closure remain unclear. This retrospective study enrolled adults with secundum ASD undergoing trans-catheter closure from January 2000 to March 2014. We analyzed the clinical characteristics of patients and assessed risk factors for new-onset atrial tachyarrhythmia defined as a composite of atrial fibrillation or flutter (AF/AFL) after ASD closure. We enrolled a total of 427 patients; 123 were male (28.8%) and the median age was 37.0 (interquartile range [IQR]: 18.3–49.0). Nineteen (4.4%) patients had documented atrial tachyarrhythmia during the follow-up period (median: 11.4 months [IQR: 5.4–24]). Patients with transient AF/AFL during closure showed a greater incidence of new-onset atrial tachyarrhythmia during the follow-up period than patients with consistent sinus rhythm during closure (27.3% vs 3.8%; P = 0.01). Most new-onset atrial tachyarrhythmias were documented within 6 months (median: 2.6 [IQR: 1.2–4.1] months) of closure. In the multivariate analysis, the risk for new-onset atrial tachyarrhythmia was significant in patients with AF/AFL during closure (hazard ratio [HR]: 9.90, 95% confidence interval [CI]: 2.86–34.20; P < 0.001), deficient posteroinferior rim (HR: 5.48, 95% CI: 1.15–25.72; P = 0.04), and age of closure over 48 years (HR: 3.30, 95% CI: 1.30–8.38; P = 0.01). In conclusion, transient AF/AFL during trans-catheter closure of ASD as well as deficient posteroinferior rim and age of closure over 48 years may be useful for predicting early new-onset atrial tachyarrhythmia after device closure. PMID:27583905

  14. Atrophy of the Heart After Insertion of a Left Ventricular Assist Device and Closure of the Aortic Valve.

    PubMed

    Roberts, William C; Hall, Shelley A; Ko, Jong M; McCullough, Peter A; Lima, Brian

    2016-03-01

    Described are findings in a 70-year-old man who had heart transplantation 4 years after treatment with a left ventricular assist device, and surgical closure of his previously replaced aortic valve. The result was a totally nonfunctioning left ventricle resulting in severe atrophy. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. An annulus fibrosus closure device based on a biodegradable shape-memory polymer network.

    PubMed

    Sharifi, Shahriar; van Kooten, Theo G; Kranenburg, Hendrik-Jan C; Meij, Björn P; Behl, Marc; Lendlein, Andreas; Grijpma, Dirk W

    2013-11-01

    Injuries to the intervertebral disc caused by degeneration or trauma often lead to tearing of the annulus fibrosus (AF) and extrusion of the nucleus pulposus (NP). This can compress nerves and cause lower back pain. In this study, the characteristics of poly(D,L-lactide-co-trimethylene carbonate) networks with shape-memory properties have been evaluated in order to prepare biodegradable AF closure devices that can be implanted minimally invasively. Four different macromers with (D,L-lactide) to trimethylene carbonate (DLLA:TMC) molar ratios of 80:20, 70:30, 60:40 and 40:60 with terminal methacrylate groups and molecular weights of approximately 30 kg mol(-1) were used to prepare the networks by photo-crosslinking. The mechanical properties of the samples and their shape-memory properties were determined at temperatures of 0 °C and 40 °C by tensile tests- and cyclic, thermo-mechanical measurements. At 40 °C all networks showed rubber-like behavior and were flexible with elastic modulus values of 1.7-2.5 MPa, which is in the range of the modulus values of human annulus fibrosus tissue. The shape-memory characteristics of the networks were excellent with values of the shape-fixity and the shape-recovery ratio higher than 98 and 95%, respectively. The switching temperatures were between 10 and 39 °C. In vitro culture and qualitative immunocytochemistry of human annulus fibrosus cells on shape-memory films with DLLA:TMC molar ratios of 60:40 showed very good ability of the networks to support the adhesion and growth of human AF cells. When the polymer network films were coated by adsorption of fibronectin, cell attachment, cell spreading, and extracellular matrix production was further improved. Annulus fibrosus closure devices were prepared from these AF cell-compatible materials by photo-polymerizing the reactive precursors in a mold. Insertion of the multifunctional implant in the disc of a cadaveric canine spine showed that these shape-memory devices could be

  16. Treatment of Angio-Seal® Vascular Closure Device-Induced Acute Femoral Artery Occlusion with SilverHawk® Directional Atherectomy

    PubMed Central

    Sharma, Rishi; Vamanan, Karthik

    2016-01-01

    Vascular closure devices provide a safe and cost-effective method to achieve rapid hemostasis and early ambulation after angiographic procedures. Rarely, they can result in arterial injury with resultant stenosis or acute arterial closure requiring open surgical intervention. We report an Angio-Seal® vascular closure device-induced acute arterial closure successfully treated percutaneously with the SilverHawk® plaque excision system. This report discusses the possible mechanisms of Angio-Seal® induced arterial occlusion and various percutaneous options for treatment. PMID:28083454

  17. 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.

  18. Safety and feasibility of intra-operative device closure of atrial septal defect with transthoracic minimal invasion

    PubMed Central

    Chen, Qiang; Cao, Hua; Zhang, Gui-Can; Chen, Liang-Wan; Chen, Dao-Zhong

    2012-01-01

    OBJECTIVE The study aims to evaluate the safety and feasibility of intra-operative device closure of atrial septal defect with transthoracic minimal invasion. METHODS From May 2006 to June 2009, 252 patients with secundum-type atrial septal defect closure were enrolled in our institution. The patients were divided into two groups, with 182 patients in group I with intra-operative device closure and 72 in group II with surgical closure. In group I, the patients’ age ranged from 3 months to 62 years (mean ± standard deviation, 19.0 ± 16.7 years). This approach involved a transthoracic minimal invasion that was performed after full evaluation of the atrial septal defect by transthoracic echocardiography, deploying the device through the delivery sheath to occlude the atrial septal defect. RESULTS In group I, 180 patients were occluded successfully under this approach. The size of the occluder device implanted ranged from 6 to 48 mm. Minor complications occurred, which included transient arrhythmias (n = 23) and pleural effusion (n = 15). Two patients with postoperative cardiac arrest were successfully cardiopulmonary resuscitated. Another two patients with occluder dislodged back into the right atrium were turned to surgical repair with cardiopulmonary bypass on the postoperative day. In group II, all patients were occluded successfully, and almost all patients needed blood transfusion and suffered from various minor complications. All discharged patients were followed up for 1–5 years. During this period, we found no recurrence, no thrombosis, even no device failure. In our comparative studies, group II had significantly longer intensive care unit (ICU) stay and hospital stay than group I (p < 0.05). The cost for group I was less than group II (p < 0.05). CONCLUSIONS Intra-operative device closure of atrial septal defect with transthoracic minimal invasion is a safe and feasible technique. It had the advantages of cost savings, yielding better

  19. A Cost-Minimization Analysis of the Angioseal Vascular Closure Device following Percutaneous Coronary Intervention

    PubMed Central

    Resnic, Frederic S.; Arora, Nipun; Matheny, Michael; Reynolds, Matthew R.

    2007-01-01

    The Angioseal vascular closure device has been shown to be safe and effective in reducing the time to hemostasis following percutaneous coronary intervention (PCI). The health economic implications of routinely using Angioseal after PCI have not been explored. We performed a cost-minimization analysis comparing routine Angioseal use after PCI to mechanical compression using a decision analytic model. The relative probabilities of 7 vascular access complications were derived from pooled analysis of published randomized trials. The incremental hospital cost of each vascular complication was estimated by a matched case control analysis of 3,943 patients who underwent PCI at our center between 1/02 and 12/04. Appropriate sensitivity and uncertainty analyses were performed. After accounting for differences in expected rates of specific complications between the two strategies, as well as the incremental costs of each vascular event, the routine use of Angioseal was associated with a reduced cost per PCI procedure of $44. Probabilistic sensitivity analysis of all model assumptions using second order Monte Carlo simulation confirmed the economic advantage of Angioseal in 74% of model replications. In conclusion, following PCI, the routine use of Angioseal for femoral vascular access management was associated with net cost savings as compared with mechanical compression. This cost savings was in addition to the previously demonstrated advantages of Angioseal in terms of patient comfort and preference. PMID:17350361

  20. Ultrasonographic features of vascular closure devices: initial and 6-month follow-up results

    PubMed Central

    2014-01-01

    Purpose: This study aimed to evaluate the ultrasonographic findings for various types of vascular closure devices (VCDs) immediately after the angiographic procedure and at 6-month follow-up. Methods: We included 18 VCDs including Angio-Seal (n=4), FemoSeal (n=8), ExoSeal (n=3), Perclose (n=2), and StarClose (n=1) in this study. Four patients were implanted with 2 VCDs at the each side of bilateral femoral arteries, while the remaining 8 patients were inserted 1 VCD at the right femoral artery. Ultrasonography was performed within 10 days and at approximately 6 months after the angiographic procedure. Ultrasonographic morphology of the attached VCD and its relationship with the arterial wall were analyzed. Results: Initial ultrasonography revealed the attached VCD as the relevant unique structure with successful deployment and hemostasis. Follow-up ultrasonography demonstrated partial absorption of hemostatic materials in cases of Angio-Seal (n=3), FemoSeal (n=5), and ExoSeal (n=3), changes in the soft tissue surrounding the femoral artery in case of Angio-Seal (n=1), arterial intimal hyperplasia in cases of FemoSeal (n=3), and no gross changes as compared with the initial ultrasonographic findings in cases of Perclose (n=2) and StarClose (n=1). Conclusion: Initial ultrasonographic evaluation reflected the unique structure of each VCD, with most of them being easily distinguishable. Follow-up ultrasonography revealed various changes in the affected vessels. PMID:25145584

  1. The Inflammatory Response to Femoral Arterial Closure Devices: A Randomized Comparison Among FemoStop, AngioSeal, and Perclose

    SciTech Connect

    Jensen, Jens Saleh, Nawzad; Jensen, Ulf; Svane, Bertil; Joensson, Anders; Tornvall, Per

    2008-07-15

    The objectives of this study were to investigate whether the systemic inflammatory response differs, in patients undergoing coronary angiography, among the arterial closure devices FemoStop, AngioSeal, and Perclose. The study is a prospective and randomized study. We measured pre- and postprocedural C-reactive protein (CRP), fibrinogen, and interleukin-6 (IL-6) plasma levels and collected clinical and procedural data on 77 patients who underwent coronary angiography because of stable angina pectoris. Patients were randomized to the following device: FemoStop (mechanical compression), AngioSeal (anchor and collagen sponge), or Perclose (nonabsorbable suture). No patient group experienced an increased incidence of vascular complications. There were no differences among the three groups regarding CRP, fibrinogen, or IL-6 values before or after coronary angiography. IL-6 levels increased 6 h after the procedure in all groups (p < 0.01), however, the increase did not differ among the groups. After 30 days there were no increased values of CRP or fibrinogen. We conclude that the femoral arterial closure devices AngioSeal and Perclose do not enhance an inflammatory response after a diagnostic coronary angiography, measured by CRP, fibrinogen, and IL-6, compared to femoral arterial closure using a mechanical compression device.

  2. Left circumflex coronary artery occlusion due to a left atrial appendage closure device

    PubMed Central

    Katona, András; Temesvári, András; Szatmári, András; Forster, Tamás; Fontos, Géza

    2015-01-01

    Nowadays, percutaneous left atrial appendage (LAA) closure is spreading, and a large number of patients with this procedure have concomitant coronary artery disease. With the presented case it could be concluded that coronary angiography is recommended before LAA closure. PMID:25848378

  3. Intracardiac echocardiography during atrial septal defect and patent foramen ovale device closure in pediatric and adolescent patients.

    PubMed

    Medford, Beth A; Taggart, Nathaniel W; Cabalka, Allison K; Cetta, Frank; Reeder, Guy S; Hagler, Donald J; Johnson, Jonathan N

    2014-09-01

    Intracardiac echocardiography (ICE) is commonly used during interventional cardiac catheterization in adults, but data regarding the use of ICE in children are limited. There are no data available comparing the effectiveness of preprocedural transthoracic echocardiography (TTE) with that of intraprocedural ICE in predicting atrial septal defect (ASD) size and rim adequacy for percutaneous closure in a pediatric population. The objectives of this study were to describe the investigators' experience using ICE in pediatric and adolescent patients and to compare the effectiveness of preprocedural TTE with that of ICE in predicting ASD size and rim adequacy for percutaneous closure. In this retrospective study, all cases in which ICE was used during ASD or patent foramen ovale closure in patients ≤21 years of age at a single institution from January 2002 through October 2013 were reviewed. All studies were performed using the Acuson AcuNav ICE system. One hundred fifteen patients (65 female; mean age, 12 ± 6 years; range, 10 months to 21 years) were included. All intracardiac echocardiographic studies were performed by the interventional cardiologist performing the catheterization. ICE was used to facilitate ASD closure in 92 patients (81%) and patent foramen ovale closure in 23 (19%). Thirty-eight patients (34%) underwent cardiac catheterization and ICE without general anesthesia. ICE was correlated highly with preprocedural TTE in predicting ASD size (r(2) = 0.76, P < .0001). In nine of 92 patients (9.8%) with ASDs, ICE identified deficient septal rims (n = 8) or complex or multiple ASDs (n = 1) that necessitated surgical closure. There were no major complications. ICE can be performed safely and effectively in a large cohort of children and adolescents undergoing percutaneous device closure. ICE may obviate the need for general anesthesia in some patients and is a reasonable alternative to transesophageal echocardiography for this catheter-based procedure in

  4. Stent-grafts in the management of hemorrhagic complications related to hemostatic closure devices: report of two cases.

    PubMed

    Giansante Abud, Daniel; Mounayer, Charbel; Saint-Maurice, Jean Pierre; Rezende, Marco Túlio Salles; Houdart, Emmanuel; Moret, Jacques

    2007-01-01

    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 to be efficient in the management of these life-threatening hemorrhagic complications following the use of the Angio-Seal hemostatic closure device.

  5. Severe spinal cord ischemic injury secondary to device embolization after transcatheter closure of a patent arterial duct.

    PubMed

    Tang, Liang; Zhou, Shenghua; Shen, Xiangqian

    2014-02-01

    Percutaneous closure of patent arterial ducts with the Amplatzer Ductal Occluder has become an effective and widely accepted alternative to surgical management. Although rarely, the occluder can be dislodged after an initially successful deployment, and with catastrophic consequences. We describe such a case in a 12-month-old girl who underwent transcatheter closure of a patent arterial duct. After device deployment, the occluder embolized in the patient's descending thoracic aorta, and severe spinal cord ischemic injury resulted. To our knowledge, ours is the first report of this complication after the deployment of an Amplatzer Ductal Occluder. We discuss pathophysiologic mechanisms that could expose patients to the risk of device dislodgment, and we review the relevant medical literature.

  6. Wire vascular closure device: evaluation of an evidence-based protocol for post-endovascular procedure patients.

    PubMed

    Rieben, Melissa A; Appling, Susan; MacDonald, Ryan

    2013-06-01

    Vascular closure devices (VCDs) can shorten the time to hemostasis, ambulation and discharge and improve patient comfort.(1) An evidence-based practice (EBP) project was initiated to assess impact of a shortened postoperative compression and bed rest protocol on patients undergoing arteriotomy using a wire vascular closure device (WVCD). Following protocol development, a post-implementation evaluation was initiated to assess selected outcomes including compression and bed rest time, complication rate and possible related variables. Following implementation of the new protocol, clinicians were able to shorten both compression and bed rest times by 50%, and Post-Anesthesia Care Unit (PACU) length of stay decreased to a maximum of 5 hours. Copyright © 2013 Society for Vascular Nursing, Inc. Published by Mosby, Inc. All rights reserved.

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

    SciTech Connect

    Giansante Abud, Daniel; Mounayer, Charbel; Saint-Maurice, Jean Pierre; Salles Rezende, Marco Tulio; Houdart, Emmanuel; Moret, Jacques

    2007-02-15

    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 to be efficient in the management of these life-threatening hemorrhagic complications following the use of the Angio-Seal hemostatic closure device.

  8. [Percutaneous closure of ostium secundum atrial septal defects using the Amplatz device. Preliminary study on 29 patients].

    PubMed

    Rey, C; Godart, F; Francart, C; Cajot, M A; Vaksmann, G; Brevière, G M

    1999-05-01

    The aim of the study was to assess the results of percutaneous closure of ostium secundum atrial septal defects (ASD) by the Amplatz device and to compare them with those obtained by other methods. Over a one year period, closure of ASD was performed in 28 patients aged 7 to 66 years (mean of 32 years) with exclusive left-to-right shunts. The selection of patients was made by transthoracic echocardiography. Cardiac catheterisation was performed to measure the stretched diameter of the defect. After patient or parental consent, the procedure was performed under general anaesthesia. The implantation was performed under transoesophageal echocardiographic control. The diameter of the Amplatz device corresponded to the stretched diameter of the ASD. The patients were discharged from hospital 48 hours later under platelet anti-aggregant therapy for 6 months. Clinical, electrocardiographic, radiological and echocardiographic examinations were performed at 1 month, 3 months and 1 year after implantation. The stretched diameter was 12-27 mm (mean 22 mm). The device was withdrawn in one case because of a double ASD and, in another patient, failure was due to embolisation of the obturator to the pulmonary artery before its implantation. The closure was complete in 21 of the 26 cases immediately after the procedure; at one month, two residual shunts were observed but they had disappeared at 3 months and at 1 year. Out of 46 ASD closed by the Sidéris button prosthesis, occlusion was total in 29 cases and partial in 17 cases. The authors conclude that the Amplatz device is an effective prosthesis for closure of ostium secundum ASD. With strict selection procedures, the results are excellent.

  9. Long Term Outcome after Application of the Angio-Seal Vascular Closure Device in Minipigs

    PubMed Central

    Kabelitz, Lisa; Nonn, Andrea; Nolte, Kay W.; Nikoubashman, Omid; Othman, Ahmed; Heringer, Sarah; Kramer, Martin; Wiesmann, Martin; Brockmann, Marc A.

    2016-01-01

    Minipigs are frequently used in (neuro-)interventional research. Longitudinal experiments may require repeated vessel access via the femoral artery. Anticoagulation and incompliance of the animals necessitates the use of a vascular closure device (VCD). The effects of the Angio-Seal VCD in minipigs were longitudinally assessed. Minipig (42±8.4 kg body weight) femoral arteries were sealed using the 8F (n = 6) or 6F (n = 7) Angio-Seal VCD. The pre-interventional femoral artery diameter was 5.1±0.4 mm (4.3–5.8 mm). Sealed puncture sites were analysed angiographically as well as by computed tomography angiography (CTA) for a mean period of 14.1±8.0 weeks (1–22 weeks). All animals were constantly treated with acetylsalicylic acid (ASS) (450 mg/d (n = 7) or 100 mg/d (n = 1)) and clopidogrel (75 mg/d (n = 8)). Non-instrumented (n = 2) and arteries sealed using the VCD (n = 2) were examined histologically. No postoperative hemorrhagic complications were observed. Three arteries were occluded after VCD placement (1 animal diagnosed after 4 weeks (8F), 2 animals after 1 week (6F)) and remained so until the end of the experiments after 22, 12 and 4 weeks, respectively. In one artery a 50% stenosis 8 weeks after application of a 6F Angio-Seal was detected. In 69.2% (n = 9) the VCD was applied without complications. Histopathological analysis of the sealed arterial segments showed subtotal obliteration of the vessel lumen, formation of collagenous tissue and partial damage of the internal elastic lamina. The Angio-Seal VCD prevents relevant hemorrhagic complications in minipigs treated with dual platelet inhibition, but is associated with increased vessel occlusion rates. PMID:27682594

  10. Effectiveness of Arterial Closure Devices for Preventing Complications With Percutaneous Coronary Intervention: An Instrumental Variable Analysis

    PubMed Central

    Wimmer, Neil J.; Secemsky, Eric A; Mauri, Laura; Roe, Matthew T.; Saha-Chaudhuri, Paramita; Dai, David; McCabe, James M.; Resnic, Frederic S.; Gurm, Hitinder S.; Yeh, Robert W.

    2016-01-01

    Background Bleeding is associated with poor outcomes after percutaneous coronary intervention (PCI). While arterial closure devices (ACDs) are widely used in clinical practice, whether they are effective in reducing bleeding complications during transfemoral PCI is uncertain. The objective of this study was to evaluate the effectiveness of ACDs for the prevention of vascular access site complications in patients undergoing transfemoral PCI using an instrumental variable approach. Methods and Results We performed a retrospective analysis of CathPCI Registry from 2009-2013 at 1,470 sites across United States. Variation in the proportion of ACDs used by each individual physician operator was used as an instrumental variable to address potential confounding. A two stage instrumental variable analysis was used as the primary approach. The main outcome measure was vascular access site complications, and non-access site bleeding was used as a “falsification endpoint” (negative control) to evaluate for potential confounding. A total of 1,053,155 ACDs were used during 2,056,585 PCIs during the study period. The vascular access site complication rate was 1.5%. In the instrumental variable analysis, the use of ACDs was associated with a 0.40% absolute risk reduction in vascular access site complications (95% confidence interval (95% CI):0.31%−0.42%, number needed to treat=250). Absolute differences in non-access site bleeding were negligible (risk difference 0.04%, 95% CI:0.01%−0.07%), suggesting acceptable control of confounding in the comparison. Conclusions ACDs are associated with a modest reduction in major bleeding after PCI. The number needed to treat with ACDs to prevent one major bleeding event is high. PMID:27059685

  11. Tulip malformation of the left atrial disc in the Lifetech Cera ASD device: a novel complication of percutaneous ASD closure.

    PubMed

    Hayes, Nicholas; Rosenthal, Eric

    2012-03-01

    A previously unreported tulip-like malformation of the left atrial disc was encountered during percutaneous closure of an atrial septal defect (ASD) using the LifeTech Cera ASD device, requiring snare assistance to permit recapture into the delivery sheath. This was likely to be as a result of attempting to recapture the left atrial disc whilst it remained in contact with some part of the atrial septum or left atrial wall. To help avoid this, it is recommended to ensure complete intracavity positioning of the Cera device prior to retrieval into the sheath. Copyright © 2011 Wiley Periodicals, Inc.

  12. Haemostasis with the FISH Vascular Closure Device after 6 French Transfemoral Accesses in Interventional Radiology: Clinical Results

    PubMed Central

    Kamusella, Peter C.; Lüdtke, Christopher W.; Scheer, Fabian; Andresen, Reimer

    2017-01-01

    Introduction Endovascular procedures have increased for different indications over the recent years. To achieve a safe haemostasis after arterial puncture and for more comfort for the patients different vascular closure devices have been developed. Aim To evaluate the effectiveness and safety of a percutaneous closure system based on a matrix patch for achieving haemostasis. Materials and Methods In this study from 2014 to 2015 a percutaneous vascular closure system Femoral Introducer Sheath and Haemostasis (FISH) was used in 54 patients (mean age 69.0±10.7 years), in an antegrade and retrograde technique within the context of an angiographic intervention. The system was used in conjunction with transfemoral approaches with a sheath size of 6F. Postinterventionally (on the following day and after 6 weeks), follow-up was conducted clinically and using colour coded ultrasound. Results Immediate haemostasis was achieved in 50/54 patients (92.6 %). In 4 cases, an immediate haemostasis was not achieved. In these cases, manual compression was successful. There was one major complication, a retroperitoneal bleeding requiring transfusion. Minor complications were not observed. Conclusion Safe and effective haemostasis is possible with the percutaneous FISH closure system at puncture sizes of 6 F. An immediate re-puncture after using FISH is possible. PMID:28384956

  13. 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

    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

  14. Cost effectiveness of left atrial appendage closure with the Watchman device for atrial fibrillation patients with absolute contraindications to warfarin.

    PubMed

    Reddy, Vivek Y; Akehurst, Ronald L; Armstrong, Shannon O; Amorosi, Stacey L; Brereton, Nic; Hertz, Deanna S; Holmes, David R

    2016-07-01

    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. 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. 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. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

  15. Comparison of outcome and complications using different types of devices for percutaneous closure of a secundum atrial septal defect in adults: a single-center experience.

    PubMed

    Post, Martijn C; Suttorp, Maarten J; Jaarsma, Wybren; Plokker, H W Thijs

    2006-03-01

    The objective of this study was to find differences in outcome and complications using three different types of devices for percutaneous atrial septal defect (ASD) closure in adults. Percutaneous closure of a secundum-type ASD is increasingly performed in adult patients. All adult patients who underwent a percutaneous closure of a secundum-type ASD in our center between November 1996 and November 2004 were included. Failure was defined as dislocation or embolization of the device, which required surgical intervention. Periprocedural and mid-term complications were registered. Sixty-five patients, mean age 45.7+/-18.1 years (18 men, 47 women), underwent a percutaneous closure of an ASD with an ASDOS in 3, an Amplatzer in 36, and a Cardioseal/Starflex closure device in 26 patients. During an overall median follow-up of 1.2 years (range, 0.1-6.7 years), the failure occurred in four patients, all Cardioseal/Starflex (P=0.04). Within the Cardioseal/Starflex subgroup, the ASD and device diameters were significantly higher in those patients in whom the primary endpoint occurred compared to the others, 18.8+/-3.8 vs. 13.0+/-3.8 mm for ASD diameter (P=0.01) and 40 (range, 40-43) vs. 33 mm (range, 20-40) for device diameter (P=0.008). Overall complications were transient arrhythmias in 15.4%, pericardial effusion in 1.5%, and transient ischemic attack in 1.5%. Complete closure 6 months after the procedure occurred in 79.6%, without difference between the devices. Percutaneous ASD closure seems to be a relatively safe and effective procedure. However, using the larger Cardioseal/Starflex devices for closure seems to be related to a higher rate of device dislocation and embolization. Copyright (c) 2006 Wiley-Liss, Inc.

  16. 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.

  17. Usefulness of early diastolic mitral annular velocity to predict plasma levels of brain natriuretic peptide and transient heart failure development after device closure of atrial septal defect.

    PubMed

    Masutani, Satoshi; Taketazu, Mio; Mihara, Chihiro; Mimura, Yuko; Ishido, Hirotaka; Matsunaga, Tamotsu; Kobayashi, Toshiki; Senzaki, Hideaki

    2009-12-15

    Device closure of atrial septal defect (ASD) is sometimes followed by elevation of plasma brain natriuretic peptide (BNP), a marker of heart failure, and progression to heart failure. This study tested the hypothesis that the underlying diastolic dysfunction, assessed on tissue Doppler images (TDI) before device closure, can predict BNP level after ASD closure. The study subjects were 39 consecutive patients (age 27.5 +/- 16.3 years, range 5 to 63) who underwent device closure for ASD. Echocardiographic evaluation using TDI and 2-dimensional and pulse wave Doppler were performed, together with plasma BNP measurement 1 day before and 2 days after ASD closure. Before ASD closure, an age-dependent decrease was noted in left ventricular relaxation, assessed by early diastolic mitral annular velocity. ASD closure resulted in a decrease in early diastolic mitral annular velocity (from 14.7 to 12.3 cm/s, p <0.05) despite an increase in the left ventricular dimension (84% to 92% vs normal, p <0.05). These changes were associated with a parallel increase in BNP (17.9 to 48.4 pg/ml, p <0.05). Stepwise multivariate linear regression identified early diastolic mitral annular velocity before ASD closure and age as independent predictors of BNP levels after ASD closure (p <0.05). Consistent with this result, 2 patients with the lowest early diastolic mitral annular velocity developed exertional dyspnea after the procedure. In conclusion, our results indicate that TDI measurements could be useful to detect underlying diastolic dysfunction that can potentially cause heart failure after ASD closure and emphasize the importance of ASD closure at a young age before impairment of left ventricular relaxation.

  18. First-in-man Percutaneous LAA Closure With an Amplatzer Amulet and TriGuard Embolic Protection Device in a Patient With LAA Thrombus.

    PubMed

    Del Furia, Francesca; Ancona, Marco B; Giannini, Francesco; Jabbour, Richard J; Regazzoli, Damiano; Mangieri, Antonio; Latib, Azeem; Colombo, Antonio; Montorfano, Matteo

    2017-04-01

    Percutaneous left atrial appendage (LAA) closure is currently utilized for the prophylaxis of thromboembolic cerebrovascular accidents in patients with non-valvular atrial fibrillation. The presence of LAA thrombus is usually considered a contraindication for the procedure, since there is a high risk of thrombus embolization. While reports in the literature have shown the feasibility of LAA closure in the presence of LAA thrombus with certain cerebral embolic protection devices, we present the first-in-man LAA closure of a patient with LAA thrombus using the TriGuard Embolic Protection Device.

  19. Prospective Nonrandomized Trial of Manual Compression and Angio-Seal and Starclose Arterial Closure Devices in Common Femoral Punctures

    SciTech Connect

    Ratnam, Lakshmi A.; Raja, Jowad; Munneke, Graham J.; Morgan, Robert A.; Belli, Anna-Maria

    2007-04-15

    We compared the use of manual compression and Angio-Seal and Starclose arterial closure devices to achieve hemostasis following common femoral artery (CFA) punctures in order to evaluate safety and efficacy. A prospective nonrandomized, single-center study was carried out on all patients undergoing CFA punctures over 1 year. Hemostasis was achieved using manual compression in 108 cases, Angio-Seal in 167 cases, and Starclose in 151 cases. Device-failure rates were low and not significantly different in the two groups (manual compression and closure devices; p = 0.8). There were significantly more Starclose (11.9%) patients compared to Angio-Seal (2.4%), with successful initial deployment subsequently requiring additional manual compression to achieve hemostasis (p < 0.0001). A significant number of very thin patients failed to achieve hemostasis (p = 0.014). Major complications were seen in 2.9% of Angio-Seal, 1.9% of Starclose, and 3.7% of manual compression patients, with no significant difference demonstrated; 4.7% of the major complications were seen in female patients compared to 1.3% in males (p = 0.0415). All three methods showed comparable safety and efficacy. Very thin patients are more likely to have failed hemostasis with the Starclose device, although this did not translate into an increased complication rate. There is a significant increased risk of major puncture-site complications in women with peripheral vascular disease.

  20. Vascular closure devices and the risk of vascular complications after percutaneous coronary intervention in patients receiving glycoprotein IIb-IIIa inhibitors.

    PubMed

    Resnic, F S; Blake, G J; Ohno-Machado, L; Selwyn, A P; Popma, J J; Rogers, C

    2001-09-01

    Vascular closure devices offer advantages over traditional means of obtaining hemostasis after percutaneous coronary intervention (PCI) in terms of patient comfort and time to ambulation. We investigate whether such devices also reduce the risk of vascular complications in selected patient populations. We conducted a retrospective analysis of all patients who underwent PCI at our institution between January 1998 and December 1999. Of 3,151 consecutive patients, 3,027 were eligible to receive vascular closure devices. Of these, 1,485 received a closure device and 1,409 received glycoprotein IIb-IIIa antagonists. The overall vascular complication rate, as defined by the need for surgical repair or transfusion, or the development of arteriovenous fistula, pseudoaneurysm, or large hematoma, was 4.20%. By univariate analysis, the use of closure devices was associated with a lower vascular complication rate (3.03% vs 5.52%; p = 0.002) and a shorter length of hospital stay (2.77 vs 3.97 days, p <0.001). Multivariate analysis showed a significant reduction in vascular complications with closure devices (odds ratio 0.59, p = 0.007). For the subgroup of patients receiving glycoprotein IIb-IIIa antagonists, the use of closure devices was associated with an even more pronounced reduction in the risk of vascular complications (odds ratio 0.45, p <0.008). Thus, the use of closure devices in selected patients undergoing PCI is associated with a low rate of vascular complications and decreased length of stay. This benefit was most marked for patients receiving glycoprotein IIb-IIIa antagonists.

  1. Obesity: An Independent Risk Factor for Insufficient Hemostasis Using the AngioSeal Vascular Closure Device After Antegrade Puncture

    SciTech Connect

    Minko, Peter Katoh, Marcus; Graeber, Stefan; Buecker, Arno

    2012-08-15

    Purpose: This study was designed to investigate the efficacy of the AngioSeal vascular closure device after antegrade puncture of the femoral artery. Methods: In a prospective study, 120 consecutive patients underwent lower limb vascular intervention by an antegrade access to the common femoral artery (CFA). After intervention, a 6F (n = 88) or an 8F (n = 32) AngioSeal vascular closure device was used to achieve hemostasis. The technical success or the cause of failure was documented. In addition, the coagulation status (platelets, INR, prothrombin time, atrial thromboplastin time (PTT)), hypertonus, locoregional habitus of the groin, body mass index (BMI), presence of calcifications, and history of previous surgical interventions of the CFA were evaluated. Results: Hemostasis was achieved in 97 patients (81%). In 12 patients (10%), persistent bleeding of the puncture site required manual compression. In another nine patients (8%) a kink of the sheath obviated the passage of the collagen plug toward the vessel, and in two patients the anchor dislodged out of the vessel, requiring manual compression. There were no significant differences between the groups of successful and unsuccessful sealing regarding the mean platelets (241 vs. 254 * 10{sup 9}/l; P = 0.86), INR (1.06 vs. 1.02; P = 0.52), prothrombin time (90% vs. 90%; P = 0.86), and PTT (30 vs. 31 s; P = 0.82). However, unsuccessful sealing was more likely in obese patients with an increased BMI (26.6 vs. 28.8 kg/m{sup 2}; P = 0.04). Conclusions: Obesity seems to be an independent risk factor for insufficient sealing using the AngioSeal vascular closure device after antegrade puncture of the CFA. In 8% of our patients, hemostasis could not be achieved due to kink of the flexible sheath.

  2. Approaches to correct device malposition in percutaneous PFO closure: anatomical and technical implications.

    PubMed

    Muench, Andreas; Boccalandro, Fernando; Ellis, Keith; Smalling, Richard W

    2005-03-01

    We describe three patients with initial failure of transcatheter patent foramen ovale closure. Two patients had residual defects successfully closed during the initial session, and one patient had a persistent shunt, which was corrected at a later time. Anatomical and technical considerations and the role of intracardiac ultrasound are discussed. Copyright 2005 Wiley-Liss, Inc.

  3. 3D printing for sizing left atrial appendage closure device: Head-to-head comparison with computed tomography and transesophageal echocardiography.

    PubMed

    Hell, Michaela M; Achenbach, Stephan; Yoo, In Seong; Franke, Joerg; Blachutzik, Florian; Roether, Jens; Graf, Verena; Raaz-Schrauder, Dorette; Marwan, Mohamed; Schlundt, Christian

    2017-07-04

    Device sizing for LAA closure using transesophageal echocardiography (TEE) can be challenging due to complex LAA anatomy. We investigated whether the use of 3D-printed left atrial appendage (LAA) models based on pre-procedural computed tomography (CT) permits accurate device sizing. 22 patients (73±8 years, 55% male) with atrial fibrillation requiring anticoagulation at high bleeding risk underwent LAA closure (WatchmanTM device). Pre-procedurally, LAA was sized by TEE and third-generation dual-source CT. Based on CT, 3D printing models of LAA anatomy were created for simulation of device implantation. Device compression was assessed in a CT scan of the 3D model with implanted device. Implantation was successful in all patients. Mean LAA ostium diameter based on TEE was 22±4 mm and based on CT 25±3 mm (p=0.014). Predicted device size based on simulated implantation in the 3D model was equal to the finally implanted device in 21/22 patients (95%). TEE would have undersized the device in 10/22 patients (45%). Device compression determined in the 3D-CT-model corresponded closely with compression upon implantation (16±3% vs. 18±5%, r=0.622, p=0.003). Patient-specific CT-based 3D printing models may assist device selection and prediction of device compression in the context of interventional LAA closure.

  4. Robotic-assisted removal of an Amplatzer atrial septal occluder device for residual shunting, closure of septal defect and simultaneous tricuspid annuloplasty.

    PubMed

    Onan, Burak; Kadirogullari, Ersin; Guler, Salih; Kahraman, Zeynep

    2017-05-03

    Complications after percutaneous atrial septal defect closure such as residual shunting or device-related events are generally treated using conventional sternotomy or thoracotomy incisions. In these cases, minimally invasive approaches including mini-sternotomy, mini-thoracotomy or endoscopic techniques can also be used in the management of complications, residual defects and concomitant procedures. However, robotic surgery is a reasonable alternative for removal of septal occluder devices and concomitant repair procedures to prevent cardiopulmonary morbidities. Herein, we report an adult, who underwent a totally endoscopic robotic removal of septal occluder device, closure of septal defect with autologous pericardial patch and tricuspid valve annuloplasty through a right atriotomy approach.

  5. Which patients might be suitable for a septal occluder device closure of postinfarction ventricular septal rupture rather than immediate surgery?

    PubMed

    Attia, Rizwan; Blauth, Christopher

    2010-11-01

    A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was: which patients might be suitable for a transcatheter closure (TCC) of their postinfarction ventricular septal rupture (VSR) rather than immediate surgery? Thirty papers were found using the reported search, five of which represented the best evidence to answer the clinical question. The main limitations were the paucity of level 1 evidence on this topic. Only one study provided a prospective series as part of a registry; the remaining were retrospective cohort analyses. Although multivariate analysis may adequately control for measurable biases, unmeasured bias may still exist and influence the results. All studies agreed that timing of intervention is critical in determining the outcome. Patient's preoperative haemodynamic status was a major determinant of postoperative survival. Successful outcome after TCC was in patients with simple defects, <15 mm in diameter that were in the sub-acute (>3.5 weeks) or chronic stage following acute myocardial infarct (AMI). Procedural success rate varied from 73.6% to 91%. Three of five studies looking at TCC closure concluded that procedural success does not necessarily translate to improved outcome. TCC in the acute setting (within four weeks of AMI) led to a high mortality (18%-65%) and increased incidence of complications (up to 41%). These included device embolization, major residual shunting, left ventricular rupture and malignant arrhythmias. One recent study correlated mortality to residual VSR [odds ratio (OR) 0.071, P=0.02], increased time from myocardial infarction to VSR diagnosis (OR 0.757, P=0.04) and increased time from VSR diagnosis to treatment (OR 0.758, P=0.04). The overwhelming recommendations were for immediate surgical intervention in cases of large VSR≥15 mm or where another indication for surgery exists. Three of five studies commented on a lack of a suitable device for PIVSR closure

  6. Clinical manifestations of heart failure abate with transcatheter aortic paravalvular leak closure using Amplatzer vascular plug II and III devices.

    PubMed

    Smolka, Grzegorz; Pysz, Piotr; Wojakowski, Wojciech; Ochała, Andrzej; Peszek-Przybyła, Ewa; Roleder, Tomasz; Jasinski, Marek; Gasior, Zbigniew

    2013-05-01

    To evaluate the transcatheter paravalvular leak closure (TPVLC) aptitude to reduce manifestations of heart failure caused by aortic paravalvular leak (PVL). TPVLC is a valuable alternative to reoperation. While technical feasibility of the method is well established, data on long-term clinical outcome are less abundant. We launched a prospective registry of patients with clinically significant aortic PVL. They were scheduled for TPVLC with Amplatzer vascular plug (AVP) II and III devices serving as occluders. The efficacy and safety were monitored at 6-month follow-up exam. The occluder deployment reached a success rate of nearly 90%. Following the procedure, we recorded significant improvement both in terms of patient functional capacity and echocardiographic determinants of left ventricular performance. Simultaneously, NT-proBNP plasma concentration and hemolysis markers decreased. Only local complications related to puncture site occurred. Heart failure caused by aortic PVL can be safely and efficiently treated with TPVLC using AVP II and III devices as occluders.

  7. Transcatheter PDA Closure Using the Gianturco-Grifka Vascular Occlusion Device.

    PubMed

    Grifka, Ronald G.

    2001-05-01

    Transcatheter interventional procedures for the treatment of congenital heart defects have become increasingly important. The patent ductus arteriosus (PDA) is a common congenital defect that is amenable to transcatheter occlusion. Several transcatheter occlusion devices are available. However, due to different PDA shapes and sizes, each device cannot be used to occlude every PDA. Thus, there is a need for new safe and effective transcatheter occlusion devices. We developed a new transcatheter device, the Gianturco-Grifka Vascular Occlusion Device (GGVOD), which consists of a nylon sack attached to an end-hole catheter. A wire is advanced through the catheter into the sack. The wire coils, filling the sack, occluding the vessel, and providing transmural pressure to maintain the sack position. Prior to release, the device may be repositioned, removed, or exchanged for a different sized device. The device is available in four sizes. We evaluated this device in a canine model, occluding subclavian and carotid arteries, and surgically created aortopulmonary shunts. All vessels were occluded completely without complication. In children, we have used the device to occlude PDA and other vascular anomalies. In every patient, the PDA (or other vessel) was occluded completely and without complication. When compared with other occlusion devices, this device has several advantages: the ability to reposition the device or remove it prior to release, the ability to conform to many vascular shapes, and four different sizes. The GGVOD has become another important tool in the transcatheter armamentarium.

  8. Immediate and short-term outcomes after percutaneous atrial septal defect closure using the new nit-occlud ASD-R device.

    PubMed

    Peirone, Alejandro; Contreras, Alejandro; Ferrero, Adolfo; da Costa, Rodrigo Nieckel; Pedra, Simone Fontes; Pedra, Carlos A C

    2014-09-01

    To evaluate the feasibility, safety, and efficacy of implantation of the new Nit Occlud ASD-R® (NOASD-R) device for percutaneous closure of ostium secundum atrial septal defects (ASD-OS). Device catheter implantation has become the method of choice for most patients with ASD-OS. No single device has proven to be ideal for this type of procedure. The NOASD-R has a distinct design that may help to overcome limitations of other devices. A prospective, single arm, observational study including all consecutive patients receiving the NOASD-R device for ASD-OS closure between October 2011 and September 2013 was performed. Patient selection, device design, deployment technique, complications, and procedural outcomes were evaluated. Seventy-four patients underwent attempted transcatheter ASD-OS closure using the NOASD-R device. Implantation of the occluder was successful in 73 patients (98.6%). The majority of patients were female (79.5%) with a median age of 17.2 years (range: 2-74). A 2-D transthoracic color-Doppler echocardiogram (TTE) obtained at the 3 or 6 month follow-up visit showed complete occlusion of the ASD-OS in 72/73 patients (98.6%). At a mean follow-up interval of 11.4 ± 6.8 months there have been no episodes of late device embolization, cardiac perforation or erosion, endocarditis, thromboembolism, wire fracture, embolic neurologic events, or death. We report the first worldwide clinical experience using the NOASD-R device for ASD-OS closure. The procedure was feasible, with a high rate of successful implantations, and safe. High ASD-OS closure rates and no complications were encountered during short-term follow-up. © 2014 Wiley Periodicals, Inc. © 2014 Wiley Periodicals, Inc.

  9. Comparison of Outcomes after Device Closure and Medication Alone in Patients with Patent Foramen Ovale and Cryptogenic Stroke in Korean Population.

    PubMed

    Moon, Jeonggeun; Kang, Woong Chol; Kim, Sihoon; Oh, Pyung Chun; Park, Yae Min; Chung, Wook-Jin; Choi, Deok Young; Lee, Ji Yeon; Lee, Yeong-Bae; Hwang, Hee Young; Ahn, Taehoon

    2016-05-01

    To compare the effectiveness of device closure and medical therapy in prevention of recurrent embolic event in the Korean population with cryptogenic stroke and patent foramen ovale (PFO). Consecutive 164 patients (men: 126 patients, mean age: 48.1 years, closure group: 72 patients, medical group: 92 patients) were enrolled. The primary end point was a composite of death, stroke, transient ischemic attack (TIA), or peripheral embolism. Baseline characteristics were similar in the two groups, except age, which was higher in the medical group (45.3±9.8 vs. 50.2±6.1, p<0.0001), and risk of paradoxical embolism score, which was higher in the closure group (6.2±1.6 vs. 5.7±1.3, p=0.026). On echocardiography, large right-to-left shunt (81.9% vs. 63.0%, p=0.009) and shunt at rest/septal hypermobility (61.1% vs. 23.9%, p<0.0001) were more common in the closure group. The device was successfully implanted in 71 (98.6%) patients. The primary end point occurred in 2 patients (2 TIA, 2.8%) in the closure group and in 2 (1 death, 1 stroke, 2.2%) in the medical group. Event-free survival rate did not differ between the two groups. Compared to medical therapy, device closure of PFO in patients with cryptogenic stroke did not show difference in reduction of recurrent embolic events in the real world's setting. However, considering high risk of echocardiographic findings in the closure group, further investigation of the role of PFO closure in the Asian population is needed.

  10. Simple excision and closure of a distal limb of loop colostomy prolapse by stapler device.

    PubMed

    Masumori, K; Maeda, K; Koide, Y; Hanai, T; Sato, H; Matsuoka, H; Katsuno, H; Noro, T

    2012-04-01

    Stomal prolapse is one of the common complications in transverse colostomy and can be managed conservatively in most cases; however, laparotomy and reconstruction of the stoma may sometimes be required, especially in case of irreducible colostomy prolapse. We have reported a simple local repair with reconstruction of the loop colostomy. We herein report a new more simple technique to avoid laparotomy and allow excision of the irreducible colostomy prolapse and complete closure of the distal limb of loop colostomy when no decompression is required in the distal limb of the stoma. In this procedure, the number of stapler and the time with blood loss for the operation can be saved.

  11. Safety and efficacy of femoral artery closure with the FemoSeal(R) device after coronary angiography using a 7 French sheath.

    PubMed

    Wanitschek, M M; Suessenbacher, A; Dörler, J; Pachinger, O; Moes, N; Alber, H F

    2011-09-01

    Post-cardiac catheterization femoral artery hemostasis can be accomplished with several mechanisms, including the FemoSeal® hemostasis device which has been designed and approved for closure of 6 French (F) arterial puncture sites. The aim of this study was to investigate whether the FemoSeal® vascular closure device can effectively and safely seal 7F arterial puncture sites after diagnostic and interventional cardiac catheterizations. Femoral artery puncture sites of 50 consecutive patients undergoing cardiac catheterization were closed with the FemoSeal® vascular closure device, according to the manufacturer's instructions. Efficacy endpoints were time to hemostasis and successful ambulation. Safety endpoints included bleeding complications, vessel occlusion and pseudoaneurysms. Mean time to hemostasis was 57.8±26.3 seconds (0-125 seconds). Hemostasis was achieved in 100 percent of the 50 patients. One patient suffered minor bleeding the next day, i.e. local hematoma. This clinical study demonstrates that the FemoSeal® vascular closure device, initially approved for closure of 6F arterial puncture sites, shows promising efficacy and safety to seal a larger (7F) femoral arterial puncture sites after diagnostic and interventional cardiac catheterizations.

  12. Cardiac Plug I and Amulet Devices: Left Atrial Appendage Closure for Stroke Prophylaxis in Atrial Fibrillation.

    PubMed

    Parashar, Akhil; Tuzcu, E Murat; Kapadia, Samir R

    2015-01-01

    Percutaneous left atrial appendage (LAA) occlusion has emerged as an exciting and effective modality for stroke prophylaxis in patients with non-valvular atrial fibrillation who are deemed too high risk for anticoagulation with warfarin or newer anticoagulants. The Amplatzer devices have been used in LAA occlusion for more than a decade, starting with off label use of an atrial septal occluder device for LAA occlusion. This was followed by introduction of a dedicated Amplatzer cardiac plug (ACP) 1 for LAA occlusion, and more recently, the second generation Amulet device, with reported better stability enhancing features, has been introduced. Both these devices are widely used outside the United States, however in the US only the WATCHMAN device has been FDA approved. Unlike the WATCHMAN device, where the evidence is continuously building as the data from two pivotal randomized controlled trials are emerging, most of the evidence for ACP devices is from pooled multicenter registry data. In this article, we review the device design, implantation techniques and the most recently published evidence for both the Amplatzer cardiac plug 1 and the newer Amulet device. Our goal is to summarize the most recent literature and discuss the current role of the Amplatzer devices in the exciting and rapidly growing field of percutaneous LAA occlusion.

  13. Echocardiographic Evaluation of Changes in Cardiac Hemodynamics and Loading Conditions after Transthoracic Minimally Invasive Device Closure of Atrial Septal Defect

    PubMed Central

    Cao, Hua; Zhang, Gui-Can; Chen, Liang-Wan; Hu, Yun-Nan

    2015-01-01

    Purpose To evaluate transthoracic minimally invasive device closure of atrial septal defects by performing transthoracic echocardiography to measure changes in cardiac hemodynamics and loading conditions. Methods Between January 2012 and December 2012, we performed transthoracic minimally invasive device closure of atrial septal defects in 95 patients with secundum atrial septal defects (ASD), and performed transthoracic echocardiography to measure blood flow velocities at the tricuspid valve orifice and at the pulmonary valve orifice, sizes of the left and right atria and ventricles, right ventricular fractional area change, right ventricular Tei index, three-dimensional right ventricular ejection fraction, tricuspid annular plane systolic excursion and left ventricular ejection fractions before the procedure and 1 week, 3 months, and 1 year post-procedure. Results Varying degrees of improvement were observed post-procedure at later time points. The maximum blood flow velocity at the pulmonary valve orifice, mean flow velocity, velocity-time integral, and A peak and E peak blood flow velocity at the tricuspid valve orifice decreased significantly post-procedure (P<0.05). In 3 months and 1 year’s follow-up, the inner diameter of the middle portion of the pulmonary artery, and diameters of the right atrium and right ventricle decreased significantly post-procedure (P<0.05). The diameters of the left atrium and left ventricle increased after the procedure (P<0.05). One week after the procedure, the right ventricular fractional area change, three-dimensional right ventricular ejection fraction, right ventricular Tei index and tricuspid annular plane systolic excursion had significantly reduced compared with the preoperative data (P<0.05). While these four parameters were still decreased at the 3 months and at 1 year’s follow-up, but the differences were not statistically significant compared with the 1 week’s postoperative data (P>0.05). One week post

  14. Closure of the alveolar cleft by bone segment transport using an intraoral tooth-borne custom-made distraction device.

    PubMed

    Hegab, Ayman F

    2012-05-01

    The fact that bone transportation generates not only bone but also surrounding soft tissues makes it an ideal technique for tissue regeneration. This study evaluates bone segment transport using an intraoral tooth-borne distraction device for alveolar cleft closure. Patients with an alveolar cleft were enrolled in the study. They were treated at the Al-Azhar University Hospital, Cairo, Egypt, between 2004 and 2007. Anterior transportation of the posterior dentoalveolar segment was performed by use of an intraoral tooth-borne custom-made distractor. Clinical evaluations included the following: preoperative and postoperative intraoral photographs, vitality testing of the teeth in the transport segment, cast analysis, and measurement of tooth mobility. Radiographic evaluations included occlusal films, orthopantomography, and computed tomography and 3D computed tomography for volumetric and densitometric evaluations of the distracted bone. After distraction was completed, the transported segments were positioned 1 to 4 mm superior to the occlusal plane. The radiographic evaluation showed residual triangular bone deficits that were closed through gingivoperiosteoplasty or bone grafting. Once the transported segments came in contact with the alveolar bone of the normal side, the intervening fibrous tissue at the docking site was removed, and docking-site surgery was then performed. The results obtained from both clinical examinations and radiographic imaging showed complete closure of the alveolar clefts. Maxillary alveolar bone transport offers an alternative technique in the latest treatment of the alveolar cleft. Copyright © 2012 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  15. How Slow Can We Go? 4 Frames Per Second (fps) Versus 7.5 fps Fluoroscopy for Atrial Septal Defects (ASDs) Device Closure.

    PubMed

    Hiremath, Gurumurthy; Meadows, Jeffery; Moore, Phillip

    2015-06-01

    Radiation exposure remains a significant concern for ASD device closure. In an effort to reduce radiation exposure, the default fluoroscopy frame rate in our Siemens biplane pediatric catheterization laboratory was reduced to 4 fps in November 2013 from an earlier 7.5 fps fluoro rate. This study aims to evaluate the components contributing to total radiation exposure and compare the procedural success and radiation exposure during ASD device closure using 4 versus 7.5 fps fluoroscopy rates. Twenty ASD device closures performed using 4 fps fluoro rate were weight-matched to 20 ASD closure procedures using 7.5 fps fluoro rate. Baseline characteristics, procedure times and case times were similar in the two groups. Device closure was successful in all but one case in the 4 fps group. The dose area product (DAP), normalized DAP to body weight, total radiation time and fluoro time were lower in the 4 fps group but not statistically different than the 7.5 fps. The number of cine images and cine times were identical in both groups. Fluoroscopy and cineangiography contributed equally to radiation exposure. Fluoroscopy at 4 fps can be safe and effective for ASD device closure in children and adults. There was no increase in procedure time, cine time, fluoro time or complications at this slow fluoro rate. There was a trend toward decreased radiation exposure as measured by indexed DAP although not statistically significant in this small study. Further study with multiple operators using 4 fps fluoroscopy for simple interventional procedures is recommended.

  16. Marine propulsion device with engine heat recovery system and streamlining hull closures

    SciTech Connect

    Haynes, H. W.

    1985-11-12

    A Marine Jet Propulsion System for use as an inboard engine for boats is herein described. An engine or motor means is attached in a driving relationship to a pump and thrust output apparatus. Heat generated by and rejected by the engine or motor is passed into the pump base for dissipation into the outputted jet thrust stream. Air and/or exhaust gas from the engine is ejected around the jet output stream to reduce against-the-hull turbulence and jet stream or thrust energy losses. Streamlining hull closures for the jet pump intake and output ports are provided to reduce system hull drag when not in use and to limit marine organism growth inside the pump.

  17. Evaluation of in vivo biocompatibility of different devices for interventional closure of the patent ductus arteriosus in an animal model

    PubMed Central

    Sigler, M; Handt, S; Seghaye, M; von Bernuth, G; Grabitz, R

    2000-01-01

    OBJECTIVE—To evaluate the in vivo biocompatibility of three different devices following interventional closure of a patent ductus arteriosus (PDA) in an animal model.
MATERIALS AND METHODS—A medical grade stainless steel coil (n = 8), a nickel/titanium coil (n = 10), and a polyvinylalcohol foam plug knitted on a titanium wire frame (n = 11) were used for interventional closure of PDA in a neonatal lamb model. The PDA had been maintained by repetitive angioplasty. Between one and 278 days after implantation the animals were killed and the ductal block removed. In addition to standard histology and scanning electron microscopy, immunohistochemical staining for biocompatibility screening was also undertaken.
RESULTS—Electron microscopy revealed the growth of a cellular layer in a cobblestone pattern on the implant surfaces with blood contact, which was completed as early as five weeks after implantation of all devices. Immunohistochemical staining of these superficial cells showed an endothelial cell phenotype. After initial thrombus formation causing occlusion of the PDA after implantation there was ingrowth of fibromuscular cells resembling smooth muscle cells. Transformation of thrombotic material was completed within six weeks in the polyvinylalcohol plug and around the nickel/titanium coil, and within six months after implantation of the stainless steel coil. An implant related foreign body reaction was seen in only one of the stainless steel coil specimens and in two of the nickel/titanium coil specimens.
CONCLUSION—After implantation, organisation of thrombotic material with ingrowth of fibromuscular cells was demonstrated in a material dependent time pattern. The time it took for endothelium to cover the implants was independent of the type of implant. Little or no inflammatory reaction of the surrounding tissue was seen nine months after implantation.


Keywords: congenital heart disease; patent ductus arteriosus; catheter technique

  18. 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

    SciTech Connect

    Pieper, Claus Christian Thomas, Daniel; Nadal, Jennifer; Willinek, Winfried A. Schild, Hans Heinz Meyer, Carsten

    2016-01-15

    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)]. 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.

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

    PubMed

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

    2017-01-01

    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). We retrospectively studied 116 patients who underwent closure of small PDAs between January 2010 and January 2015. 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. All statistical calculations were performed using Statistical Package for the Social Science software. P <0.05 were considered significant. 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. 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.

  20. A novel vacuum assisted closure therapy model for use with percutaneous devices

    PubMed Central

    Cook, Saranne J.; Nichols, Francesca R.; Brunker, Lucille B.; Bachus, Kent N.

    2016-01-01

    Long-term maintenance of a dermal barrier around a percutaneous prosthetic device remains a common clinical problem. A technique known as Negative Pressure Wound Therapy (NPWT) uses negative pressure to facilitate healing of impaired and complex soft tissue wounds. However, the combination of using negative pressure with percutaneous prosthetic devices has not been investigated. The goal of this study was to develop a methodology to apply negative pressure to the tissues surrounding a percutaneous device in an animal model; no tissue healing outcomes are presented. Specifically, four hairless rats received percutaneous porous coated titanium devices implanted on the dorsum and were bandaged with a semi occlusive film dressing. Two of these animals received NPWT; two animals received no NPWT and served as baseline controls. Over a 28-day period, both the number of dressing changes required between the two groups as well as the pressures were monitored. Negative pressures were successfully applied to the periprosthetic tissues in a clinically relevant range with a manageable number of dressing changes. This study provides a method for establishing, maintaining, and quantifying controlled negative pressures to the tissues surrounding percutaneous devices using a small animal model. PMID:24685323

  1. [Technical Note: Subclavian artery misplacement of a 12F Shaldon catheter: percutaneous repair with a local closure device under temporary balloon tamponade].

    PubMed

    Wildberger, J E; Katoh, M; Fussen, R; Günther, R W

    2006-06-01

    A case of subsequent percutaneous repair using a local closure device with a collagen block (VasoSeal(R)) and temporary balloon tamponade after inadvertent subclavian artery misplacement of a 12F Shaldon catheter is reported. Balloon occlusion safely prevented displacement of collagen into the vascular lumen by occluding the 12F entry site. Furthermore, collagen-induced coagulation was facilitated.

  2. A novel method of creation of a fenestration in nitinol occluder devices used in closure of hypertensive patent arterial ducts

    PubMed Central

    Singhi, Anil Kumar; Sivakumar, Kothandam

    2016-01-01

    Test occlusion with a balloon is done to predict operability of large hypertensive patent ductus arteriosus (PDA). If the fall in the pulmonary artery pressures is inadequate, a complete closure is not desired. To create a predictable premeasured fenestration in a nitinol occluder device used for closing hypertensive PDA. A large nitinol occluder device was punctured with an 18G needle to advance a 0.035˝ stiff guide wire through the occluder before loading it into the delivery system. The occluder with the guidewire was then deployed across the PDA. A coronary guide catheter was later threaded through the guidewire into the fabric of the device, which was still held by the delivery cable. A coronary stent was deployed across the fenestration in the occluder to keep it patent. An 8-year-old boy with Down syndrome and hypertensive PDA was hemodynamically assessed. Even though there was a fall in the pulmonary vascular resistance index and pressures on test occlusion, the pulmonary artery pressures were labile with fluctuations. A customized fenestration was made in a 16 mm muscular ventricular septal defect occluder (MVSO) with a 4.5 mm bare-metal coronary stent. The pulmonary artery pressures remained at half of the aortic pressures after the procedure. This fenestration model precisely and predictably fenestrated a large occluder device used to close a hypertensive large PDA. Long-term patency of these fenestrations has to be assessed on the follow-up, and may be improved through larger fenestrations, systemic anticoagulation and use of covered stents. PMID:27011694

  3. A novel method of creation of a fenestration in nitinol occluder devices used in closure of hypertensive patent arterial ducts.

    PubMed

    Singhi, Anil Kumar; Sivakumar, Kothandam

    2016-01-01

    Test occlusion with a balloon is done to predict operability of large hypertensive patent ductus arteriosus (PDA). If the fall in the pulmonary artery pressures is inadequate, a complete closure is not desired. To create a predictable premeasured fenestration in a nitinol occluder device used for closing hypertensive PDA. A large nitinol occluder device was punctured with an 18G needle to advance a 0.035˝ stiff guide wire through the occluder before loading it into the delivery system. The occluder with the guidewire was then deployed across the PDA. A coronary guide catheter was later threaded through the guidewire into the fabric of the device, which was still held by the delivery cable. A coronary stent was deployed across the fenestration in the occluder to keep it patent. An 8-year-old boy with Down syndrome and hypertensive PDA was hemodynamically assessed. Even though there was a fall in the pulmonary vascular resistance index and pressures on test occlusion, the pulmonary artery pressures were labile with fluctuations. A customized fenestration was made in a 16 mm muscular ventricular septal defect occluder (MVSO) with a 4.5 mm bare-metal coronary stent. The pulmonary artery pressures remained at half of the aortic pressures after the procedure. This fenestration model precisely and predictably fenestrated a large occluder device used to close a hypertensive large PDA. Long-term patency of these fenestrations has to be assessed on the follow-up, and may be improved through larger fenestrations, systemic anticoagulation and use of covered stents.

  4. Right Ventricular Perforation From a Floating Rib Following Deep Sternal Wound Infection Debridement and Application of a Vacuum-Assisted Closure Device: A Case Report and Literature Review

    PubMed Central

    2017-01-01

    Introduction: Deep sternal wound infection following major cardiac surgery is a deleterious complication with sequelae that can be life threatening. The use of vacuum-assisted closure therapy in management of sternal wounds with resultant right ventricular rupture has been documented in the cardiothoracic and to a lesser extent in the reconstructive literature. Methods/Case Report: We present a case of a 67-year-old male patient who suffered from right ventricular perforation from a floating rib following debridement of a deep sternal wound infection and placement of a vacuum-assisted closure device. Results: Despite meticulous debridement and ensuring the release of all retrosternal adhesions, massive bleeding was encountered shortly after application of the vacuum-assisted closure device. Fortunately, quick identification of the complication and the application of direct manual pressure allowed for swift return to the operating room for repair of the defect. The patient secondarily underwent definitive closure of the mediastinal wound with an omental flap and bilateral pectoral advancement flaps. Discussion: Following the conclusion of this article, the reconstructive surgeon should be able to (1) identify patients at risk for ventricular perforation, (2) exhaust all means intraoperatively to prevent cardiac perforation when using vacuum-assisted closure therapy, (3) comprehend the physiology associated with vacuum-assisted closure use in this patient population, (4) have protocols in place for the management of patients with deep sternal wound infection with vacuum-assisted closure therapy postoperatively, and (5) understand basic tenets of ventricular rupture treatment should this occur to ensure prompt repair and survival. PMID:28458765

  5. The Use of ExoSeal Vascular Closure Device for Direct Antegrade Superficial Femoral Artery Puncture Site Hemostasis

    SciTech Connect

    Rimon, Uri Khaitovich, Boris; Yakubovich, Dmitry; Bensaid, Paul Golan, Gil; Silverberg, Daniel

    2015-06-15

    PurposeThis study was designed to assess the efficacy and safety of the ExoSeal vascular closure device (VCD) to achieve hemostasis in antegrade access of the superficial femoral artery (SFA).MethodsWe retrospectively reviewed the outcome of ExoSeal VCD used for hemostasis in 110 accesses to the SFA in 93 patients between July 2011 and July 2013. All patients had patent proximal SFA based on computer tomography angiography or ultrasound duplex. Arterial calcifications at puncture site were graded using fluoroscopy. The SFA was accessed in an antegrade fashion with ultrasound or fluoroscopic guidance. In all patients, 5–7F vascular sheaths were used. The ExoSeal VCD was applied to achieve hemostasis at the end of the procedure. All patients were clinically examined and had ultrasound duplex exam for any puncture site complications during the 24 h postprocedure.ResultsIn all procedures, the ExoSeal was applied successfully. We did not encounter any device-related technical failure. There were four major complications in four patients (3.6 %): three pseudoaneurysms, which were treated with direct thrombin injection, and one hematoma, which necessitated transfusion of two blood units. All patients with complications were treated with anticoagulation preprocedure or received thrombolytic therapy.ConclusionsThe ExoSeal VCD can be safely used for antegrade puncture of the SFA, with a high procedural success rate (100 %) and a low rate of access site complications (3.6 %)

  6. Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series.

    PubMed

    Haas, Nikolaus A; Soetemann, Dagmar B; Ates, Ismail; Baspinar, Osman; Ditkivskyy, Igor; Duke, Christopher; Godart, Francois; Lorber, Avraham; Oliveira, Edmundo; Onorato, Eustaquio; Pac, Feyza; Promphan, Worakan; Riede, Frank-Thomas; Roymanee, Supaporn; Sabiniewicz, Robert; Shebani, Suhair Omar; Sievert, Horst; Tin, Do; Happel, Christoph M

    2016-10-01

    The Occlutech Figulla ASD device series (OFSO) shows an improved device design for interventional ASD closure, larger follow-up series are missing. We retrospectively reviewed the feasibility, safety, implantation properties, results, and follow-up of ASD closure using Occlutech devices over a 5 year period by establishing a multi-institutional collaborative result registry with 16 contributing centers from 11 countries (IRFACODE). In 1315 patients of all age groups (female 66.9%), successful (98%) ASD closure was performed (mean age 28.9 years, weight 52 kg, height 148.6 cm). Of the defects, 47.9% showed no or only a deficient aortic rim; in 11.9%, there was more than one defect; a septum aneurysm was present in 21.5%; and the mean implanted device size was 20.5 mm. Immediate closure was achieved in 78.6%, at discharge in 83.1%, and 96.4% and 97.3% at 6 and 12 months follow-up, respectively. During a mean follow-up of 2.7 years (in total 3597 patient years), significant complications were minimal (total = 8, <1%) with secondary device embolizations in five and AV-blocks in three patients. No erosion or death was reported. ASD closure using OFSO is feasible in a large variety of patients, safe with only a minimal risk of severe side effects and especially without any aortic erosions despite a large percentage of large and complicated defects. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  7. Efficacy of bronchoscopic closure of a bronchopleural fistula with amplatzer devices: long-term follow-up.

    PubMed

    Fruchter, Oren; El Raouf, Bayya Abed; Abdel-Rahman, Nader; Saute, Milton; Bruckheimer, Elchanan; Kramer, Mordechai R

    2014-01-01

    The development of a bronchopleural fistula (BPF) is associated with high rates of morbidity and mortality. We have developed a minimally invasive method of bronchoscopic BPF closure using Amplatzer devices (AD) and Amplatzer vascular plugs (AVP), with excellent short-term results. The aim of the present report was to explore the long-term outcome of patients treated by Amplatzer occluders and the durability of this novel modality of BPF treatment. A total of 31 central BPF in 31 patients (mean age 66.8 years, range 19-91) were sealed under moderate sedation bronchoscopically by either AD (n = 19) or AVP (n = 12). The average follow-up period was 17.6 months (range 1-68 months). The main etiology for BPF was surgery (n = 24), pneumonectomy (n = 14) or lobectomy/segmentectomy (n = 10). The underlying disease was either primary (n = 19) or metastatic (n = 2) lung cancer. The immediate success rate was 96% as symptoms related to BPF disappeared in 30 of the 31 patients. Short-term (<30 days) mortality was 13% (4 patients). At follow-up, 14 patients (45%) are still alive. Out of 12 patients with late mortality, in 5 patients (41%) the death was directly related to cancer relapse, and no patient died due to BPF recurrence. Endobronchial closure of BPF using both types of Amplatzer occluders (AD and AVP) is a minimally invasive effective modality of treatment with high safety profile and satisfactory long-term outcome considering the poor prognosis in this particular group of patients. © 2013 S. Karger AG, Basel.

  8. Off-label use of the Angioseal vascular closure device for femoral arteriotomy: retrospective analysis of safety and efficacy.

    PubMed

    Shah, Sumedh S; Perez, Giancarlo; Snelling, Brian M; Haussen, Diogo C; Sur, Samir; Sharma, Ishna; Yavagal, Dileep R; Elhammady, Mohamed Samy; Peterson, Eric C

    2017-10-01

    Angioseal, an arteriotomy closure device (ACD), functions as a collagen plug that physically closes arteriotomy sites and can simultaneously induce platelet activation and aggregation. When used 'on-label', the safety and efficacy profile of Angioseal is superior compared with those of other ACDs. However, Angioseal is sometimes deployed in less than ideal situations. Therefore, we sought to assess the safety and efficacy of 'off-label' Angioseal use in patients undergoing femoral arteriotomies. We performed a retrospective review of all femoral arterial angiograms executed at our institution between 2008 and 2014. Patients whose femoral punctures did not fit the criteria for on-label Angioseal use were included, and were dichotomized based on vascular closure (off-label Angioseal vs manual compression). Of the 521 patients (1023 angiograms) reviewed, 303 (58.2%) patients had off-label Angioseal groin punctures. Mean patient age was 46.2±14.0 years, and 113 were men. 234 patients (77%) had off-label Angioseal deployment while 69 (22%) individuals received manual pressure, serving as controls. Demographic and procedural variables were nearly identical between the two groups but the Angioseal group comprised mostly patients that underwent neurointerventional procedures and thus received intraprocedural heparinization (41%) more often than the manual compression group (19%). The overall rate of major complications associated with off-label Angioseal deployment was low (<0.85%), and clinical complications were not independently associated with Angioseal use (OR 0.76 (95% CI 0.06 to 8.86); p=0.69). Off-label use of Angioseal was found to be safe and was not associated with an increased complication rate in our cohort. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  9. Small bowel obstruction after TAPP repair caused by a self-anchoring barbed suture device for peritoneal closure: case report and review of the literature.

    PubMed

    Köhler, G; Mayer, F; Lechner, M; Bittner, R

    2015-06-01

    Transabdominal preperitoneal hernioplasty (TAPP) is a common procedure for groin hernia repair in adults. The peritoneal closure after mesh placement can be performed in various ways. In any case, thorough closure is recommended to avoid mesh exposure to the viscera with the risk of adhesions and bowel incarceration into peritoneal defects. Postoperative intestinal obstructions can mainly occur due to adhesions or bowel herniation through peritoneal defects into the dissected preperitoneal space. Incarcerations can also occur as a consequence of trocar site herniation. Recently barbed self-anchoring knotless suturing devices are frequently used for peritoneal closure. The correct handling of such sutures is crucial to avoid potential complications. Despite of accurate management, bowel adherence and injuries or volvulus can occur. We present an unusual case of a postoperative small bowel obstruction owing to strained adhesions and ingrowth between a small bowel segment and a polyglyconate unidirectional self-anchoring barbed suture device. Medline and PudMed databases were searched using the below-mentioned keywords and the literature on efficacy and safety of barbed sutures for peritoneal closure is reviewed as well as the usage of such devices in other fields of surgery.

  10. 27 CFR 26.231 - 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 the Virgin Islands General § 26.231 Affixing closures. Closures or other devices...

  11. 27 CFR 26.231 - 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 the Virgin Islands General § 26.231 Affixing closures. Closures or other devices...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. A cost-minimization analysis of the angio-seal vascular closure device following percutaneous coronary intervention.

    PubMed

    Resnic, Frederic S; Arora, Nipun; Matheny, Michael; Reynolds, Matthew R

    2007-03-15

    The Angio-Seal vascular closure device has been shown to be safe and effective in decreasing the time to hemostasis after percutaneous coronary intervention (PCI). The health economic implications of routinely using Angio-Seal after PCI have not been explored. We performed a cost-minimization analysis comparing routine Angio-Seal use after PCI with mechanical compression using a decision analytic model. The relative probabilities of 7 vascular access complications were derived from pooled analysis of published randomized trials. The incremental hospital cost of each vascular complication was estimated by a matched case-control analysis of 3,943 patients who underwent PCI at our center from January 2002 and December 2004. Appropriate sensitivity and uncertainty analyses were performed. After accounting for differences in expected rates of specific complications between the 2 strategies and the incremental costs of each vascular event, the routine use of Angio-Seal was associated with a lower cost per PCI procedure of 44 dollars. Probabilistic sensitivity analysis of all model assumptions using second-order Monte Carlo simulation confirmed the economic advantage of Angio-Seal in 74% of model replications. In conclusion, after PCI, the routine use of Angio-Seal for femoral vascular access management was associated with net cost savings compared with mechanical compression. This cost savings was in addition to the previously demonstrated advantages of Angio-Seal in terms of patient comfort and preference.

  18. Occurrence of discal and non-discal changes after sequestrectomy alone versus sequestrectomy and implantation of an anulus closure device.

    PubMed

    Barth, Martin; Fontana, Johann; Thomé, Claudius; Bouma, Gerrit J; Schmieder, Kirsten

    2016-12-01

    Sequestrectomy alone represents a procedure for the treatment of lumbar disc herniation. For selected cases, an anulus closure device (ACD) can be implanted which may result in lower reoperation rates. However, comparative magnetic resonance imaging (MRI) changes and their clinical relevance of both procedures are unclear and have not been reported so far. Clinical and MRI data of patients after limited discectomy with ACD implantation (group ACD; N=45) and patients after sequestrectomy alone (group S; N=40) with primary lumbar disc herniation were compared retrospectively. Pain intensity on the visual analogue pain scale (VAS), oswestry disability index (ODI) or the patient satisfaction index (PSI) were collected. Disc signal intensity, Modic type changes, endplate reactions, anular tears and reherniations were investigated using MRI before and <18months postoperative. Morphologic changes were correlated with clinical outcome. There was no difference in VAS back, VAS leg or ODI/PSI after the operation although group S showed significantly more reherniations in MRI. The overall rate of repeated surgery at the same level was similar with a trend in favour of the ACD group (P=0.729). Significantly more patients of the ACD group experienced endplate erosions after surgery (P<0.001). Both groups experienced progression of disc signal intensity, Modic type changes, and anular tears with most MRI signs being without clinical relevance. ACD implantation is associated with a significantly lower reherniation rate in MRI but showed a significantly higher rate of endplate erosions. The structural changes do not appear to be clinically relevant.

  19. Network Meta-analysis of Randomized Trials on the Safety of Vascular Closure Devices for Femoral Arterial Puncture Site Haemostasis

    PubMed Central

    Jiang, Jun; Zou, Junjie; Ma, Hao; Jiao, Yuanyong; Yang, Hongyu; Zhang, Xiwei; Miao, Yi

    2015-01-01

    The safety of vascular closure devices (VCDs) is still debated. The emergence of more related randomized controlled trials (RCTs) and newer VCDs makes it necessary to further evaluate the safety of VCDs. Relevant RCTs were identified by searching PubMed, EMBASE, Google Scholar and the Cochrane Central Register of Controlled Trials electronic databases updated in December 2014. Traditional and network meta-analyses were conducted to evaluate the rate of combined adverse vascular events (CAVEs) and haematomas by calculating the risk ratios and 95% confidence intervals. Forty RCTs including 16868 patients were included. Traditional meta-analysis demonstrated that there was no significant difference in the rate of CAVEs between all the VCDs and manual compression (MC). Subgroup analysis showed that FemoSeal and VCDs reported after the year 2005 reduced CAVEs. Moreover, the use of VCDs reduced the risk of haematomas compared with MC. Network meta-analysis showed that AngioSeal, which might be the best VCD among all the included VCDs, was associated with reduced rates of both CAVE and haematomas compared with MC. In conclusion, the use of VCDs is associated with a decreased risk of haematomas, and FemoSeal and AngioSeal appears to be better than MC for reducing the rate of CAVEs. PMID:26349075

  20. Network Meta-analysis of Randomized Trials on the Safety of Vascular Closure Devices for Femoral Arterial Puncture Site Haemostasis.

    PubMed

    Jiang, Jun; Zou, Junjie; Ma, Hao; Jiao, Yuanyong; Yang, Hongyu; Zhang, Xiwei; Miao, Yi

    2015-09-08

    The safety of vascular closure devices (VCDs) is still debated. The emergence of more related randomized controlled trials (RCTs) and newer VCDs makes it necessary to further evaluate the safety of VCDs. Relevant RCTs were identified by searching PubMed, EMBASE, Google Scholar and the Cochrane Central Register of Controlled Trials electronic databases updated in December 2014. Traditional and network meta-analyses were conducted to evaluate the rate of combined adverse vascular events (CAVEs) and haematomas by calculating the risk ratios and 95% confidence intervals. Forty RCTs including 16868 patients were included. Traditional meta-analysis demonstrated that there was no significant difference in the rate of CAVEs between all the VCDs and manual compression (MC). Subgroup analysis showed that FemoSeal and VCDs reported after the year 2005 reduced CAVEs. Moreover, the use of VCDs reduced the risk of haematomas compared with MC. Network meta-analysis showed that AngioSeal, which might be the best VCD among all the included VCDs, was associated with reduced rates of both CAVE and haematomas compared with MC. In conclusion, the use of VCDs is associated with a decreased risk of haematomas, and FemoSeal and AngioSeal appears to be better than MC for reducing the rate of CAVEs.

  1. MRI after implantation of a novel femoral closure device following intra-arterial catheterisation: implications for subsequent contrast-enhanced MR angiography.

    PubMed

    Mohrs, Oliver K; Petersen, Steffen E; Nowak, Bernd; Kauczor, Hans-Ulrich; Voigtlaender, Thomas

    2010-05-01

    To assess MRI safety aspects and artefacts of a novel femoral artery closure device during contrast-enhanced MR angiography in patients following intra-arterial catheterisation. Ten consecutive patients underwent MRI within 24 h of coronary angiography and placement of a femoral artery closure device. We used a T2-weighted gradient-echo MRI sequence to measure the device-related artefact size in comparison with a phantom image, phase-contrast flow measurement proximal to, at the level of and distal to the device to quantify potential differences in flow velocity and contrast-enhanced 3D gradient-echo MR angiography to differentiate potential femoral artery stenosis from device-related artefacts. The mean size of the oval-shaped artefact was 8.4 x 6.6 mm (+/-1.0 x 0.8 mm) and was almost identical to the maximum artefact size of the phantom measurement (8.3 x 5.7 mm). Device placement did not result in an increased peak velocity (proximal 69 +/- 23 cm/s, at the level of 64 +/- 11 cm/s and distal to the device 63 +/- 12 cm/s, p = 0.67). The mean artefact penetration into the vessel lumen was 0.5 +/- 0.5 mm (percentage vessel narrowing 7.0 +/- 6%; range 0-16%). The MR conditional StarClose femoral artery closure device was used safely within 24 h of deployment at 1.5 T. Despite clip-related artefacts MR angiography will allow for easy differentiation of clip-related artefacts from high-grade atherosclerotic stenosis.

  2. Angioseal VIP® vs. StarClose SE® closure devices: a comparative analysis in non-cardiological procedures.

    PubMed

    Lucatelli, Pierleone; Fanelli, Fabrizio; Cannavale, Alessandro; Corona, Mario; Cirelli, Carlo; D'Adamo, Alessandro; Salvatori, Filippo M; Catalano, Carlo

    2017-02-01

    The aim of this paper was to compare the use of two different commercially available vascular closure devices (VCD), Angioseal VIP® (St. Jude Medical, St. Paul, MN, USA) and StarClose SE (Abbott Laboratories, Abbott Park, IL, USA). From January 2010 to January 2012, 347 patient underwent retrograde femoral arterial puncture for different interventional procedures (angioplasty, stenting, embolization for bleeding, fibrinolysis for ischemia and chemoembolization). Hemostasis was achieved by deployment of an Angioseal VIP® (N.=184) or StarClose SE® (N.=163). In 94 cases, the retrograde femoral access was bilateral and managed with two StarClose SE devices (N.=53) or an Angioseal VIP® plus a StarClose SE® (N.=41). Technical success was obtained in 95.1% (330/347) of patients. Overall time to hemostasis (TTH) and time to ambulation (TTA) were 5,5±1,5 min (range 3-8 min) and 6±2.5 hr (range 2-9 hours) respectively. No statistical significative difference (P>0.05) were appreciable between to groups for both TTH and TTA: Angioseal VIP® TTH was 5.3±1.4 min and StarClose SE® TTH was 5.6±1.6 min; Angioseal VIP® TTA was 5.9±1.8 hr and StarClose SE® TTA was 6.1±1.9 hr. VAS scores result underline a mild difference between two devices. Angioseal VIP® patients experience a mild to moderate pain within the first 3 minutes from the deployment. Whereas StarClose SE® patients still experience pain at 5 minutes from deployment. The device failure rate was 4.9% (17 cases) and included 13 minor complications and 4 major complications. Minor complications (3.75%) occurred during the initial phase and consisted in recurrent wound bleeding (N.=5 StarClose SE®; N.=4 Angioseal VIP®) treated with manual compression, and hematoma (N.=2 StarClose SE®; N.=2 Angioseal VIP®) that solved spontaneously. The 4 major complications (1,15%) were: 1 Angioseal-related common femoral artery (CFA) obstruction treated with surgical bypass from the CFA to the superficial femoral artery; 1

  3. Incomplete left atrial appendage occlusion and thrombus formation after Watchman implantation treated with anticoagulation followed by further transcatheter closure with a second-generation Amplatzer Cardiac Plug (Amulet device).

    PubMed

    Lam, Simon Cheung Chi; Bertog, Stefan; Sievert, Horst

    2015-02-01

    We report a case of incomplete left atrial appendage (LAA) closure after Watchman device (Atritech, Boston Scientific, Natrick, MA) implantation which subsequently developed a thrombus 3 years after the initial procedure. The thrombus resolved after a short period of anticoagulation with warfarin, and the LAA was successfully occluded with a second-generation Amplatzer Cardiac Plug (Amulet device, AGA, St Jude Medical, Minneapolis, MN). Incomplete LAA closure may be associated with increased risk of thrombus formation and further closure with a second device after a course of anticoagulation may be a reasonable and feasible strategy. © 2014 Wiley Periodicals, Inc. © 2014 Wiley Periodicals, Inc.

  4. 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

  5. Intermediate- and long-term follow-up of device closure of patent arterial duct with severe pulmonary hypertension: factors predicting outcome.

    PubMed

    Sadiq, Masood; Rehman, Asif U; Hyder, Najam; Qureshi, Ahmad U; Kazmi, Tehmina; Qureshi, Shakeel A

    2017-01-01

    In patients with large patent arterial ducts and severe pulmonary hypertension, the natural history of progression of pulmonary hypertension is very variable. Whether to close or not to close is often a difficult decision, as there are no established haemodynamic parameters predicting reversibility. The objectives of this study were to evaluate the results of device closure of large patent arterial ducts with severe pulmonary hypertension after 2 years of age and to determine haemodynamic variables associated with its regression during long-term follow-up. A total of 45 patients, with median age of 10 (2-27) years, with large patent arterial ducts and severe pulmonary hypertension, were considered. Haemodynamic variables were assessed in air, oxygen, and after occlusion. The follow-up was performed to assess regression of pulmonary hypertension. Device closure was successful in 43 (96%) patients. Pulmonary artery systolic and mean pressures decreased from 79 to 67 mmHg and from 59 to 50 mmHg, respectively (p25% (both in oxygen) (p=0.007). Device closure of large patent arterial ducts with severe pulmonary hypertension is safe and effective. Pulmonary vascular resistance index and systolic and mean pulmonary artery pressures in oxygen are the key prognostic variables predicting regression of pulmonary hypertension.

  6. Device closure of patent foramen ovale versus medical therapy in cryptogenic stroke: a systematic review and meta-analysis.

    PubMed

    Khan, Abdur R; Bin Abdulhak, Aref A; Sheikh, Mujeeb A; Khan, Sobia; Erwin, Patricia J; Tleyjeh, Imad; Khuder, Sadik; Eltahawy, Ehab A

    2013-12-01

    This study sought to perform a meta-analysis of randomized controlled trials comparing device closure with medical therapy in the prevention of recurrent neurological events in patients with cryptogenic stroke and patent foramen ovale. The optimal strategy for secondary prevention of cryptogenic stroke with a patent foramen ovale is unclear. Several databases were searched from their inception to March 2013, which yielded 3 eligible studies. The results were pooled as per the different patient populations defined in the studies:-intention-to-treat, per-protocol, and as-treated cohorts. A generic inverse method was used based on time-to-event outcomes in a fixed-effect model. A supplementary analysis pooled the results from only 2 trials (RESPECT [Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment] and PC Trial [Randomized Clinical Trial Comparing the Efficacy of Percutaneous Closure of Patent Foramen Ovale (PFO) With Medical Treatment in Patients With Cryptogenic Embolism]) as a similar device was used in them. Our meta-analysis yielded effect-estimate hazard ratios of 0.67 (95% confidence interval [CI]: 0.44 to 1.00, I(2) = 0%) in the intention-to-treat cohort, 0.62 (95% CI: 0.40 to 0.95). I(2) = 0%) in the per-protocol cohort, and 0.61 (95% CI: 0.40 to 0.95, I(2) = 38%) in the as-treated cohort, showing beneficial effects of device closure. The results became more robust with pooled results from RESPECT and the PC Trial: The effect-estimate hazard ratios being 0.54 (95% CI: 0.29 to 1.01, I(2) = 0%), 0.48 (95% CI: 0.24 to 0.94, I(2) = 26%), and 0.42 (95% CI: 0.21 to 0.84, I(2) = 26%) in the intention-to-treat, per-protocol, and as-treated populations, respectively. Our meta-analysis suggests that PFO closure is beneficial as compared to medical therapy in the prevention of recurrent neurological events. This meta-analysis helps to further strengthen the role of device closure in cryptogenic

  7. Short and long term complications of device closure of atrial septal defect and patent foramen ovale: meta-analysis of 28,142 patients from 203 studies.

    PubMed

    Abaci, Adnan; Unlu, Serkan; Alsancak, Yakup; Kaya, Ulker; Sezenoz, Burak

    2013-12-01

    Device closure of atrial septal defect (ASD) and patent foramen ovale (PFO) are both associated with short- and long-term complications. Our knowledge of the complication rates of ASD and PFO closure is limited. Our objective was to review the peri-procedural and long-term complications of ASD and PFO closure. Medline, EMBASE, and Scopus databases were searched between 1973 and 2012. A total of 28,142 patients from 203 case series were included. Of these 203 articles, 111 were reporting ASD closure, 61 were reporting PFO closure, and 31 were reporting both. Pooled incidence rates of cardiac complications were calculated separately for peri-procedural and at follow-up. Peri-procedural major complications were reported from 0% to 9.4%, with a pooled estimate rate of 1.4% (95% CI: 1.3-1.6%). It was 1.6% (95% CI: 1.4-1.8%) in ASD group, 1.1% (95% CI: 0.9-1.3%) in PFO group, and 1.3% (95% CI: 0.9-1.9%) in ASD/PFO group. The most common major complication was the device embolization requiring surgery. Peri-procedural minor complications were reported with a pooled estimate rate of 1.4% (95% CI: 1.2-1.7%). It was 1.6% (95% CI: 1.2-2.1%) in ASD group, 1.3% (95% CI: 1.0-1.7%) in PFO group, and 1.5% (95% CI: 1.1-1.2.1%) in ASD/PFO group. The most frequent major complications at follow-up were cerebrovascular events [1.3% (95% CI: 1.1-1.6%)] and device thrombosis [1.2% (95% CI: 1.0-1.4%)]. Both were more frequent in PFO group. Device closure of ASD and PFO are associated with non-negligible serious complications, both in early and long-term. Copyright © 2013 Wiley Periodicals, Inc.

  8. 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.

  9. Fluoroscopy vs. traditional guided femoral arterial access and the use of closure devices: a randomized controlled trial.

    PubMed

    Abu-Fadel, Mazen S; Sparling, Jeffrey M; Zacharias, Soni J; Aston, Christopher E; Saucedo, Jorge F; Schechter, Eliot; Hennebry, Thomas A

    2009-10-01

    To compare the effectiveness of accessing the common femoral artery (CFA) using fluoroscopic guidance (FG) versus traditional anatomic landmark guidance (TALG) during cardiac catheterization and to determine the effect of the two modalities on the appropriateness for use of vascular closure devices (VCDs). Previous studies have shown a consistent relationship between the head of the femur and the CFA, yet there is no prospective data validating the superiority of fluoroscopy-assisted CFA access. A total of 972 patients were randomized to either FG or TALG access. The primary endpoint of the study was the angiographic suitability of the puncture site for VCD use. Secondary endpoints included arteriotomy location, time and number of attempts needed to obtain access, and the incidence of vascular complications. Of these, 474 patients were randomized into the FG arm and 498 patients into the TALG arm. A total of 79.5% of patients in the fluoroscopy arm and 80.7% in the traditional arm (P = 0.7) were deemed angiographically suitable for VCD based on the arteriotomy. The fluoroscopy group had significantly less arteriotomies below the inferior border of the head of the femur (P = 0.03). Total time for sheath insertion (105.7 +/- 130.7 vs. 106.5 +/- 152.6 sec) and number of arterial punctures (1.1 +/- 0.4 vs. 1.1 +/- 0.5) did not differ among the FG and TALG, respectively. The rates of vascular complications were not different. The angiographic suitability for VCD was not different between FG and TALG groups. Fluoroscopy decreased the number of low arteriotomies. The time to sheath insertion, number of arterial punctures needed to obtain access, and the incidence of complications were also similar.

  10. Quantitative Impact of Cardiovascular Risk Factors and Vascular Closure Devices on the Femoral Artery after Repeat Cardiac Catheterization

    PubMed Central

    Tiroch, Klaus A.; Matheny, Michael E.; Resnic, Frederic S.

    2010-01-01

    Background We evaluated the exact quantitative long-term impact of repeated catheterizations, vascular closure devices (VCDs) and cardiovascular risk factors on the femoral artery after cardiac catheterization. Methods A total of 2,102 available femoral angiograms from 827 consecutive patients were analyzed using caliper-based quantitative vascular analysis (QVA). These patients underwent coronary interventions between 01/2005-04/2007, and had at least one additional catheterization procedure through the ipsilateral femoral access site from 12/2001 until 01/2008. Multivariate analysis was performed to control for confounding variables. The primary outcome was change in artery size. Results The average punctured artery diameter was 6.5mm±2.1mm. The average time between first case and last follow-up was 349 days. There was no significant change of the punctured artery size over time after the index procedure (P=0.15) and no change associated with the use of VCDs (P=0.25) after multivariate analysis. Smaller arteries were associated with female gender (−1.22mm, P<0.0001), presence of angiographic peripheral vascular disease (PVD, −1.19mm, P<0.0001), and current (−0.48mm, P=0.001) or former (−0.23mm, P=0.01) smoking status, while previous statin therapy was associated with an increase in artery size (+0.47mm, P<0.0001). VCDs were used less often compared to manual compression in cases preceding the first detection of angiographic PVD (P<0.001). Conclusion VCDs are not associated with a change in the artery size or progression of PVD. Overall, there is no change in vessel size over time after repeat catheterizations, with a decrease in vessel size associated with current and former smoking, and an increase with previous statin therapy. PMID:20102878

  11. Use of a home vacuum-assisted closure device in the burn population is both cost-effective and efficacious.

    PubMed

    Mushin, Oren P; Bogue, Jarrod T; Esquenazi, Mica D; Toscano, Nicole; Bell, Derek E

    2017-05-01

    The vacuum assisted closure device (VAC) improves wound-healing when utilized as a bolster to secure split thickness skin grafts (STSG). Patients typically remain hospitalized for VAC therapy; however, home VACs (hVAC) are now available. Limited studies examine burns treated with hVAC as a STSG bolster. A retrospective study of records from an ABA verified regional burn center was conducted over 23 months. Patients included STSGs for burn. Data points included demographics, burn mechanism and location, graft characteristics, hospital length of stay (LOS), and time to heal. Fifty patients were included, with average age of 39 years (range <1-83years). Average burn TBSA was 1.27±1.42 (range 0.05-8.18). Grafted area average was 102.9±128.1cm(2). The most commonly treated areas were the leg/foot, thigh, and torso (53%, 16%, and 16%, respectively). Average LOS was 1.1±1.2 days. Mean graft-take was 99.2±2.8% with one patient undergoing repeat STSG. Average post-operative time to heal was 16±6 days. A 5-day inpatient stay with a VAC costs an average of $34,635, compared to $9134 for an hVAC over the same period. The hVAC is a cost-effective STSG bolster in the burn population for appropriate candidates. Excellent graft-take and low morbidity rates imply that this is an efficacious alternative for STSG bolster. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  12. The New 3D Printed Left Atrial Appendage Closure with a Novel Holdfast Device: A Pre-Clinical Feasibility Animal Study

    PubMed Central

    Brzeziński, M.; Bury, K.; Dąbrowski, L.; Holak, P.; Sejda, A.; Pawlak, M.; Jagielak, D.; Adamiak, Z.; Rogowski, J.

    2016-01-01

    Introduction Many patients undergoing cardiac surgery have risk factors for both atrial fibrillation (AF) and stroke. The left atrial appendage (LAA) is the primary site for thrombi formation. The most severe complication of emboli derived from LAA is stroke, which is associated with a 12-month mortality rate of 38% and a 12-month recurrence rate of 17%. The most common form of treatment for atrial fibrillation and stroke prevention is the pharmacological therapy with anticoagulants. Nonetheless this form of therapy is associated with high risk of major bleeding. Therefore LAA occlusion devices should be tested for their ability to reduce future cerebral ischemic events in patients with high-risk of haemorrhage. Aim The aim of this study was to evaluate the safety and feasibility of a novel left atrial appendage exclusion device with a minimally invasive introducer in a swine model. Materials and Methods A completely novel LAA device, which is composed of two tubes connected together using a specially created bail, was designed using finite element modelling (FEM) to obtain an optimal support force of 36 N at the closure line. The monolithic form of the occluder was obtained by using additive manufacturing of granular PA2200 powder with the technology of selective laser sintering (SLS). Fifteen swine were included in the feasibility tests, with 10 animals undergoing fourteen days of follow-up and 5 animals undergoing long-term observation of 3 months. For one animal, the follow-up was further prolonged to 6 months. The device was placed via minithoracotomy. After the observation period, all of the animals were euthanized, and their hearts were tested for LAA closure and local inflammatory and tissue response. Results After the defined observation period, all fifteen hearts were explanted. In all cases the full closure of the LAA was achieved. The macroscopic and microscopic evaluation of the explanted hearts showed that all devices were securely integrated in the

  13. 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.

  14. 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.

  15. Suitability of a 7-F ExoSeal Vascular Closure Device for Femoral Artery Punctures Made by 8-F or 9-F Introducer Sheaths.

    PubMed

    Goto, Shunsaku; Ohshima, Tomotaka; Ishikawa, Kojiro; Yamamoto, Taiki; Nishizawa, Toshihisa; Shimato, Shinji; Kato, Kyozo

    2017-08-01

    To establish the safety and efficacy of the 7-F ExoSeal device for the closure of femoral puncture sites made by 8-F or 9-F introducer sheaths. Between January 2013 and December 2016, 332 patients (mean age 68.4±12.1 years; 195 men) underwent neurointerventional procedures via percutaneous puncture of the common femoral artery and an 8-F (n=272, 81.9%) or 9-F (n=60, 18.1%) introducer. The access sites were sealed with a 7-F ExoSeal in all cases. Procedure success and closure-related complication rates were evaluated, and risk factors for complications were analyzed by comparing patient characteristics between those who did and did not experience complications. Procedure success rates were 99.3% in the 8-F group and 100% in the 9-F group. The overall complication rate was 6.3% (n=17; all in the 8-F group), of which 13 (4.8%) were minor sequelae, including access-site hematoma (n=8), oozing (n=3), pseudoaneurysm (n=1), and retroperitoneal bleeding (n=1). Among the 4 (1.5%) major complications were 3 instances of bleeding requiring a blood transfusion and 1 surgical vascular repair. No complications were observed in the 9-F group. Patients who experienced complications had significantly longer activated clotting times (262±46 vs 218±55 seconds; p<0.001) compared with patients without complications. A 7-F ExoSeal vascular closure device is safe and effective for the closure of femoral puncture sites made by 8-F or 9-F introducer sheaths.

  16. [Early deambulation following cardiac catheterization by the use of 6 Fr Angio-Seal, a new hemostatic percutaneous puncture closure device].

    PubMed

    Díaz De La Llera, L S; Fournier Andray, J A

    2001-12-01

    Efficacy of the hemostatic puncture closure 8 Fr Angio-Seal device for percutaneous puncture closure after a catheterism has been previously demonstrated, but the experience provided has been obtained with 8 Fr devices. At present the device has been modified and its size reduced to 6 Fr. In this pilot study we evaluate the efficacy of the new hemostatic 6 Fr Angio-Seal device and its safety when early deambulation post-diagnostic and/or therapeutic catheterization is established. Prospective study of 150 consecutive patients randomized either for application of the 6 Fr Angio-Seal device (group A; n = 75), in which early ambulation was indicated, or manual compression (group B; n = 75), with ambulation 12 h after cardiac catheterization. Basal data, including clinical and angiographic characteristics and previous treatment with heparin and platelet aggregation inhibitors were similar in both groups. The time of hemostasia was significantly shorter in group A than in group B (118 +/- 210 s in A vs 1320 +/- 370 s in B; p (3/4) 0,001), and with early ambulation (3,1 +/- 0,4 h in A vs 12,3 +/- 3,1 h in B; p (3/4) 0,001) no local complications were observed. The 6 Fr Angio-Seal hemostatic device diminished the hemostasia time and early ambulation could be achieved. In this pilot study no complications due to early movilization were observed, but the safety of the new hemostatic device after diagnostic or therapeutic catheterizations needs to be evaluated in greater series.

  17. Vascular complications after balloon aortic valvuloplasty in recent years: Incidence and comparison of two hemostatic devices.

    PubMed

    Dall'Ara, Gianni; Santarelli, Andrea; Marzocchi, Antonio; Bacchi Reggiani, Maria Letizia; Sabattini, Maria Rita; Moretti, Carolina; Marrozzini, Cinzia; Taglieri, Nevio; Baldazzi, Federica; Franco, Nicoletta; Ortolani, Paolo; Chiarabelli, Matteo; Rodinò, Giulio; Piovaccari, Giancarlo; Rapezzi, Claudio; Saia, Francesco

    2017-10-05

    To define the incidence of vascular complications (VC) after balloon aortic valvuloplasty (BAV) in recent years, and to compare the performance of two vascular closure devices (VCD). VC remain the most frequent drawback of BAV and are associated with adverse clinical outcomes. All BAV procedures performed at 2 high-volume centers over a 6-year period (n = 930) were collected in prospective registries and investigated to assess the incidence of Valve Academic Research Consortium-2 (VARC-2) defined VC. Incidence of life-threatening, major and minor bleeding was also assessed. In-hospital major adverse cardiac and cerebrovascular events (MACCE) rate (composite of in-hospital death, myocardial infarction, TIA/stroke, and life-threatening bleeding) as well as 30-day survival was compared between a suture-mediated closure system and a collagen plug hemostatic device. A 9 Fr arterial sheath was used in most of the patients (84.1%). Vascular closure was obtained with the Angio-Seal in 643 patients (69.1%) and the ProGlide in 287 (30.9%). The overall incidence of major VC was 2.7%, and minor VC 6.6%, without significant differences between groups. The Angio-Seal group was associated with a higher rate of small hematomas (6.9% vs. 3.5%, P = 0.042), whilst blood transfusions were more frequent in the ProGlide group (6.6% vs. 3.5%, P = 0.034). Rates of in-hospital MACCE and 30-day survival were similar. Use of either VCD was not independently associated with major VC. VC rate after BAV is fairly low in experienced centers without major differences between the 2 most used VCD. © 2017 Wiley Periodicals, Inc.

  18. [Evaluation of the results of percutaneous closure by means of the Amplatzer device in pediatric patients with intra-auricular communication (IAC)].

    PubMed

    Delgadillo-Pérez, Saturnino; Torres-Martel, José Miguel; Barrera de León, Juan Carlos

    2015-01-01

    To describe the results of percutaneous closure by means of the Amplatzer Septal Occluder (ASO) device in pediatric patients with intra-auricular communication (IAC). Descriptive transversal study in patients submitted to percutaneous closure of IAC from March 2005 to March 2013. Patients aged <16 years, weight>6 kg, IAC type ostium segundum, and patent foramen ovale, with border separations borders>5 mm, and absence of coexisting pathology were included in the study. We excluded from the study children with severe pulmonary blood pressure/arterial hypertension. Descriptive statistics with the SPSS v. 20.0 statistical software package. We included in the study 28 patients, feminine gender (n=19, 68%), median age=8 years (range, 4-14), weight 30.7 kg (range, 15-69). New York Heart Association (NYHA) functional class I (n=21, 75%), II (n=7, 25%). Median IAC size, 15.50 mm (range, 5-25), and a median ASO size of 17.54 mm (range, 8-28). After ASO placement, 100% presented NYHA I at one month, cardiac murmur (n=2, 7.1%), cessation of cardiac murmur at month 6 (n=28, 100%), without evidence of arrhythmias at one month 100%, residual short circuit at 24 hours (n=4, 14%), complete occlusion at month 6 (n=28, 100%), normalization size of VD, and cessation of tricuspid insufficiency 100% at one year. Complications included minimal bleeding during the procedure (n=2, 7%), transitory cephalea (n=5, 18%), and dysautonomia (n=1, 4%). Percutaneous closure of IAC of children fitted with the ASO device is safe and exhibits good results.

  19. 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.

  20. Reversal of severe mitral regurgitation by device closure of a large patent ductus arteriosus in a premature infant.

    PubMed

    Kheiwa, Ahmed; Ross, Robert D; Kobayashi, Daisuke

    2017-01-01

    We report a critically ill premature infant with severe mitral valve regurgitation associated with pulmonary hypertension and a severely dilated left atrium from a large patent ductus arteriosus. The mitral valve regurgitation improved significantly with normalisation of left atrial size 4 weeks after percutaneous closure of the patent ductus arteriosus. This case highlights the potential reversibility of severe mitral valve regurgitation with treatment of an underlying cardiac shunt.

  1. Efficacy and Safety of a Novel Vascular Closure Device (Glubran 2 Seal) After Diagnostic and Interventional Angiography in Patients with Peripheral Arterial Occlusive Disease

    SciTech Connect

    Del Corso, Andrea; Bargellini, Irene Cicorelli, Antonio; Perrone, Orsola; Leo, Michele; Lunardi, Alessandro; Alberti, Aldo; Tomei, Francesca; Cioni, Roberto; Ferrari, Mauro; Bartolozzi, Carlo

    2013-04-15

    To prospectively evaluate safety and efficacy of a novel vascular closure device (Glubran 2 Seal) after peripheral angiography in patients with peripheral arterial occlusive disease (PAOD). From December 2010 to June 2011, all consecutive patients with PAOD undergoing peripheral angiography were prospectively enrolled onto the study after percutaneous antegrade or retrograde puncture of the common femoral artery. After angiography, the Glubran 2 Seal device was used to achieve hemostasis. The following data were registered: technical success and manual compression duration, patients' discomfort (scale 0-5), operators' technical difficulty (scale 0-5), and vascular complications. The site of hemostasis was evaluated by clinical inspection and color-coded Duplex ultrasound performed 1 day and 1 month after the procedure. One hundred seventy-eight patients were enrolled (112 male, mean age 70.8 years) with a total of 206 puncture sites, including 104 (50.5 %) antegrade accesses. The device was successful in 198(96.1 %) of 206 procedures, with 8 cases of manual compression lasting longer than 5 min (maximum 20 min). No major vascular complications were observed, resulting in 100 % procedural success. Minor complications occurred in seven procedures (3.4 %), including two cases of pseudoaneurysms, successfully treated by ultrasound-guided glue injection. The mean {+-} standard deviation score for patients' discomfort was 0.9 {+-} 0.7, whereas the mean score for operators' difficulty was 1.2 {+-} 0.9. In patients with PAOD, the Glubran 2 Seal represents a simple, painless, and efficient vascular closure device, able to achieve hemostasis both in antegrade and retrograde accesses.

  2. 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

  3. 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...

  4. 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...

  5. 21 CFR 878.4011 - Tissue adhesive with adjunct wound closure device for topical approximation of skin.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 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...

  6. 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...

  7. Management of pleural empyema with a vacuum-assisted closure device and reconstruction of open thoracic window in a patient with liver cirrhosis.

    PubMed

    Munguía-Canales, Daniel Alejandro; Vargas-Mendoza, Gary Kosai; Alvarez-Bestoff, Gustavo; Calderón-Abbo, Moisés Cutiel

    2013-10-01

    The patient is a 21-year-old female, diagnosed with cryptogenic cirrhosis at the age of 9. She presented with left post-pneumonic empyema that did not remit with conventional medical management and evolved with fistulization to the skin in the 7th intercostal space in the left subscapular region. We performed an open thoracic window procedure, and on the 6th day the patient was sent home with a portable vacuum-assisted closure device, with changes of the material every 4 days until the cavity was completed obliterated (92 days). Imaging tests showed full expansion of the lung, and chest wall reconstruction was performed with titanium rods. The high mortality of empyema in patients with liver disease requires both implementing and searching for new adjuvant therapies, like the use of vacuum-assisted closure systems and reconstruction with titanium rods. Controlled studies with a wide range of cases are needed for proper evaluation. Copyright © 2012 SEPAR. Published by Elsevier Espana. All rights reserved.

  8. Nevada Test Site closure program

    SciTech Connect

    Shenk, D.P.

    1994-08-01

    This report is a summary of the history, design and development, procurement, fabrication, installation and operation of the closures used as containment devices on underground nuclear tests at the Nevada Test Site. It also addresses the closure program mothball and start-up procedures. The Closure Program Document Index and equipment inventories, included as appendices, serve as location directories for future document reference and equipment use.

  9. Robotic atrial septal defect closure.

    PubMed

    Senay, Sahin; Gullu, Ahmet Umit; Kocyigit, Muharrem; Degirmencioglu, Aleks; Karabulut, Hasan; Alhan, Cem

    2014-01-01

    Atrial septal defect (ASD) is one of the most common congenital cardiac diseases. This pathology can be treated with percutaneous devices. However, some of the ASDs are not suitable for device closure. Also, there may be device-related late complications of transcatheter ASD closure. Currently, robotic surgical techniques allow surgeons to close ASDs in a totally endoscopic fashion with a high success rate and a low complication rate. This study demonstrates the basic concepts and technique of robotic ASD closure. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  10. Transcatheter closure of atrial septal defect protects from pulmonary edema: septal occluder device gradually reduces LR shunt.

    PubMed

    Murakami, Tsutomu; Nakazawa, Gaku; Horinouchi, Hitomi; Torii, Sho; Ijichi, Takeshi; Ohno, Yohei; Amino, Mari; Shinozaki, Norihiko; Ogata, Nobuhiko; Yoshimachi, Fuminobu; Yoshioka, Koichiro; Ikari, Yuji

    2017-01-01

    A 56-year-old woman was diagnosed as atrial septal defect (ASD) with pulmonary hypertension; pulmonary blood flow/systemic blood flow (Qp/Qs) of 2.3, pulmonary artery pressure (PAP) of 71/23(39) mmHg and diastolic dysfunction of left ventricle. PAP was improved after medical therapy; therefore, transcatheter ASD closure was performed. Seven days later, left-sided heart failure occurred, however, the improvement of Qp/Qs (1.7) and PAP of 51/21(32) was confirmed. Diuretic therapy was introduced which led to further decrease of PAP 40/12(25) and Qp/Qs (1.1). Because of gradual decrease of Qp/Qs, this patient appeared to be protected from acute pulmonary edema.

  11. Helium bombardment leak testing of the closure disk weld for MC2949, MC3004, and MC3095 pyrotechnic devices

    SciTech Connect

    Dudley, W.A.

    1980-03-31

    A helium bombardment leak test procedure was developed to determine the leak level of the closure disk weld performed on three nearly identical pyrotechnic actuators. The inspection procedure is capable of leak testing any of the three product types at a rate better than 120 units per 8-hr work shift. Testing is performed on a 100% sample plan and employs a go/no-go bombardment leak rate acceptance specification of 3 x 10/sup -9/ atm-cm/sup 3/-sec/sup -1/. In addition to the current test procedure and results, this report includes a description of procedure and results associated with the test as initially performed. Other applications of the current technique are also listed.

  12. Performance Assessment of Bi-Directional Knotless Tissue-Closure Devices in Juvenile Chinook Salmon Surgically Implanted with Acoustic Transmitters, 2009 - Final Report

    SciTech Connect

    Woodley, Christa M.; Wagner, Katie A.; Bryson, Amanda J.

    2012-11-09

    The purpose of this report is to assess the performance of bi-directional knotless tissue-closure devices for use in tagging juvenile salmon. This study is part of an ongoing effort at Pacific Northwest National Laboratory (PNNL) to reduce unwanted effects of tags and tagging procedures on the survival and behavior of juvenile salmonids, by assessing and refining suturing techniques, suture materials, and tag burdens. The objective of this study was to compare the performance of the knotless (barbed) suture, using three different suture patterns (treatments: 6-point, Wide “N”, Wide “N” Knot), to the current method of suturing (MonocrylTM monofilament, discontinuous sutures with a 2×2×2×2 knot) used in monitoring and research programs with a novel antiseptic barrier on the wound (“Second Skin”).

  13. Giant eccrine adenocarcinoma of the scalp with intracranial invasion: resection and reconstruction using a vacuum-assisted closure device: technical case report.

    PubMed

    Donovan, Daniel J; Person, Donald A

    2006-04-01

    Carcinoma of the adnexal structures of the skin is a rare malignancy, and is even more unusual in the scalp. We report an unusual case of scalp adnexal carcinoma of eccrine origin that went untreated for years, resulting in a giant tumor with extension through the cranium. The tumor resection and reconstruction of the cranium and scalp defects posed unique challenges. A 54-year-old woman experienced a large recurrence of her scalp adnexal carcinoma after an incomplete wide local excision, which invaded through the cranium. The entire vertex of the scalp and cranium were removed en bloc. After cranioplasty, a free vascularized muscle flap was used for soft tissue coverage, but failed owing to poor vascular inflow. A large area of dura was left open, using a vacuum-assisted wound closure device to generate granulation tissue by secondary intention. Another split thickness skin graft was used to provide a cosmetically acceptable outcome. Scalp adnexal tumors of eccrine origin rarely metastasize and can be resected for cure with complete removal. Reconstruction options for large scalp and cranial tumors may be limited, and allowing the dura to granulate by secondary intention has been very rarely described. The novel use of a vacuum-assisted wound closure device was a very useful adjunct in this situation, and may be beneficial in the reconstruction of other patients with large scalp and cranial defects after neurosurgical procedures. It should be used with caution, since it may risk injury to a major venous sinus, especially when used in the midline, or cerebrospinal fluid leakage.

  14. Novel stroke risk reduction in atrial fibrillation: left atrial appendage occlusion with a focus on the Watchman closure device

    PubMed Central

    Alipour, Arash; Wintgens, Lisette I S; Swaans, Martin J; Balt, Jippe C; Rensing, Benno J W M; Boersma, Lucas V A

    2017-01-01

    Atrial fibrillation (AF) remains an important clinical problem with severe complications such as stroke, which especially harms those with risk factors as calculated by the CHADS2 or CHA2DS2-VASc. Until now, no therapy has proven 100% effective against AF. Since the left atrial appendage (LAA) is the most prominent nonvalvular AF-related thromboembolic source and (novel) oral anticoagulant [(N)OAC] carries the hazard of bleeding, LAA occlusion may be an alternative, especially in patients who are ineligible for (N)OAC therapy. In this review, we discuss several LAA occlusion techniques with a focus on the Watchman device since this device is the most thoroughly studied device of all. PMID:28293114

  15. Device sizing for transcatheter closure of ruptured sinus of Valsalva as per echocardiography color Doppler turbulent flow jet diameter.

    PubMed

    Ahmed, Khurshid; Munawar, Muhammad; Chakraborty, Rabin; Hartono, Beny; Yusri, Achmad

    2015-01-01

    Rupture of sinus of Valsalva (SV) is a rare occurrence with a wide spectrum of presentation, ranging from an asymptomatic murmur to cardiogenic shock or even sudden cardiac death. We hereby report a case which was successfully closed by transcatheter technique. In this case, ruptured SV was entered from the aorta, an arteriovenous loop was created and device was implanted using a venous approach. The procedure was safe, effective and uncomplicated, obviating the need for surgery. In this case, the authors report for the first time the use of echo color Doppler turbulent flow jet diameter as a reference value for sizing the device.

  16. A Remote-Controlled Airbag Device Can Improve Upper Airway Collapsibility by Producing Head Elevation With Jaw Closure in Normal Subjects Under Propofol Anesthesia

    PubMed Central

    Ishizaka, Satoru; Kobayashi, Masato; Kajihara, Hiroki; Koga, Kazuya; Sugahara, Hirofumi; Ishimatsu, Takakazu; Kurata, Shinji; Kirkness, Jason P.; Oi, Kumiko; Ayuse, Takao

    2014-01-01

    Continuous maintenance of an appropriate position of the mandible and head purely by manual manipulation is difficult, although the maneuver can restore airway patency during sleep and anesthesia. The aim of this paper was to examine the effect of head elevation with jaw closure using a remote-controlled airbag device, such as the airbag system, on passive upper airway collapsibility during propofol anesthesia. Seven male subjects were studied. Propofol infusion was used for anesthesia induction and maintenance, with a target blood propofol concentration of 1.5–2 \\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{upgreek} \\usepackage{mathrsfs} \\setlength{\\oddsidemargin}{-69pt} \\begin{document} }{}\\(\\mu \\) \\end{document}g/ml. Nasal mask pressure (\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{upgreek} \\usepackage{mathrsfs} \\setlength{\\oddsidemargin}{-69pt} \\begin{document} }{}\\({P}_{\\text {N}}\\) \\end{document}) was intermittently reduced to evaluate upper airway collapsibility (passive \\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{upgreek} \\usepackage{mathrsfs} \\setlength{\\oddsidemargin}{-69pt} \\begin{document} }{}\\({P}_{_{\\text {CRIT}}}\\) \\end{document}) and upstream resistance (\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{upgreek} \\usepackage{mathrsfs} \\setlength{\\oddsidemargin}{-69pt} \\begin{document} }{}\\({R}_{_{\\text {US}}}\\) \\end{document}) at three different head and jaw positions, jaw opening position in the supine position, jaw opening position in the sniffing position with 6-cm head elevation, and jaw

  17. The Vacuum-Assisted Closure (VAC) device for hastened attachment of a superficial inferior-epigastric flap to third-degree burns on hand and fingers.

    PubMed

    Weinand, Christian

    2009-01-01

    The vacuum-assisted closure (VAC) device has a wide range of clinical applications, including treatment of infected surgical wounds, traumatic wounds, pressure ulcers, wounds with exposed bone and hardware, diabetic foot ulcers, and venous stasis ulcers. Increased release of growth factors has been described, leading to improved vascularization and thereby formation of new tissue. The system is also used in burn surgery for reconstructive purposes. In this case report, a patient suffered from a third-degree burn injury to the dorsum of the hand with exposure of tendons, necessitating the use of a flap reconstruction. The patient was treated with a superficial inferior-epigastric artery-based flap and the VAC system was applied in a created glove-like shape. Hastened attachment of the flap onto the exposed fingers was observed after 4 days. The author reports on the additional use of the VAC system to hasten flap attachment in a patient with a burn injury to the dorsum of the hand.

  18. Clinical and Subclinical Femoral Vascular Complications after Deployment of two Different Vascular Closure Devices or Manual Compression in the Setting of Coronary Intervention

    PubMed Central

    Yeni, Hakan; Axel, Meissner; Örnek, Ahmet; Butz, Thomas; Maagh, Petra; Plehn, Gunnar

    2016-01-01

    Background: In the past two decades vascular closure devices (VCD) have been increasingly utilized as an alternative to manual compression after percutaneous femoral artery access. However, there is a lack of data confirming a significant reduction of vascular complication in a routine interventional setting. Systematic assessment of puncture sites with ultrasound was hardly performed. Methods: 620 consecutive patients undergoing elective or urgent percutaneous coronary intervention were randomly allocated to either Angioseal (AS; n = 210), or Starclose (SC; n = 196) or manual compression (MC; n = 214). As an adjunct to clinical evaluation vascular ultrasonography was used to assess the safety of each hemostatic method in terms of major and minor vascular complications. The efficacy of VCDs was assessed by achievement of puncture site hemostasis. Results: No major complications needing transfusion or vascular surgery were observed. Furthermore, the overall incidence of clinical and subclinical minor complications was similar among the three groups. There was no differences in the occurrence of pseudoaneurysmata (AS = 10; SC = 6; MC = 10), arteriovenous fistula (AS = 1; SC = 4; MC = 2) and large hematoma (AS = 11; SC = 10; MC = 14). The choice of access site treatment had no impact in the duration of hospital stay (AS = 6.7; SC = 7.4; MS = 6.4 days). Conclusions: In the setting of routine coronary intervention AS and SC provide a similar efficacy and safety as manual compression. Subclinical vascular injuries are rare and not related to VCD use. PMID:27076781

  19. Transcatheter closure of atrial septal defect and interatrial communications with a new self expanding nitinol double disc device (Amplatzer septal occluder): multicentre UK experience.

    PubMed

    Chan, K C; Godman, M J; Walsh, K; Wilson, N; Redington, A; Gibbs, J L

    1999-09-01

    To review the safety and efficacy of the Amplatzer septal occluder for transcatheter closure of interatrial communications (atrial septal defects (ASD), fenestrated Fontan (FF), patent foramen ovale (PFO)). Prospective study following a common protocol for patient selection and technique of deployment in all participating centres. Multicentre study representing total United Kingdom experience. First 100 consecutive patients in whom an Amplatzer septal occluder was used to close a clinically significant ASD or interatrial communication. All procedures performed under general anaesthesia with transoesophageal echocardiographic guidance. Interatrial communications were assessed by transoesophageal echocardiography with reference to size, position in the interatrial septum, proximity to surrounding structures, and adequacy of septal rim. Stretched diameter of the interatrial communications was determined by balloon sizing. Device selection was based on and matched to the stretched diameter of the communication. Success defined as deployment of device in a stable position to occlude the interatrial communication without inducing functional abnormality or anatomical obstruction. Occlusion status determined by transoesophageal echocardiography during procedure and by transthoracic echocardiography on follow up. Clinical status and occlusion rates assessed at 24 hours, one month, and three months. 101 procedures were performed in 100 patients (86 ASD, 7 FF, 7 PFO), age 1.7 to 64.3 years (mean (SD), 13.3 (13.9)), weight 9.2 to 100.0 kg (mean 32.5 (23.5)). Procedure time ranged from 30 to 180 minutes (mean 92.4 (29.0)) and fluoroscopy time from 6.0 to 49.0 minutes (mean 16.1 (8.0)). There were seven failures, all occurring in patients with ASD, and one embolisation requiring surgical removal. Immediate total occlusion rate was 20.4%, rising to 84.9% after 24 hours. Total occlusion rates at the one and three month follow up were 92.5% and 98.9%, respectively. Complications

  20. Visual Closure.

    ERIC Educational Resources Information Center

    Groffman, Sidney

    An experimental test of visual closure based on an information-theory concept of perception was devised to test the ability to discriminate visual stimuli with reduced cues. The test is to be administered in a timed individual situation in which the subject is presented with sets of incomplete drawings of simple objects that he is required to name…

  1. Analysis of Alfvén eigenmode destabilization by energetic particles in Large Helical Device using a Landau-closure model

    NASA Astrophysics Data System (ADS)

    Varela, J.; Spong, D. A.; Garcia, L.

    2017-04-01

    Energetic particle populations in nuclear fusion experiments can destabilize the Alfvén Eigenmodes through inverse Landau damping and couplings with gap modes in the shear Alfvén continua. We use the reduced MHD equations to describe the linear evolution of the poloidal flux and the toroidal component of the vorticity in a full 3D system, coupled with equations of density and parallel velocity moments for the energetic particles. We add the Landau damping and resonant destabilization effects using a closure relation. We apply the model to study the Alfvén mode stability in the inward-shifted configurations of the Large Helical Device (LHD), performing a parametric analysis of the energetic particle β ({βf} ) in a range of realistic values, the ratios of the energetic particle thermal/Alfvén velocities ({{V}\\text{th}}/{{V}A0} ), the magnetic Lundquist numbers (S) and the toroidal modes (n). The n  =  1 and n  =  2 TAEs are destabilized, although the n  =  3 and n  =  4 TAEs are weakly perturbed. The most unstable configurations are associated with the density gradients of energetic particles in the plasma core: the TAEs are destabilized, even for small energetic particle populations, if their thermal velocity is lower than 0.4 times the Alfvén velocity. The frequency range of MHD bursts measured in the LHD are 50-70 kHz for the n  =  1 and 60-80 kHz for the n  =  2 TAE, which is consistent with the model predictions. ).

  2. Cost-effectiveness of contemporary vascular closure devices for the prevention of vascular complications after percutaneous coronary interventions in an all-comers PCI population.

    PubMed

    Kerré, Steven; Kustermans, Lise; Vandendriessche, Tom; Bosmans, Johan; Haine, Steven E; Miljoen, Hielko; Vrints, Christiaan J; Beutels, Philippe; Wouters, Kristien; Claeys, Marc J

    2014-06-01

    The present observational case-control study assessed the cost-effectiveness of contemporary vascular closure devices (VCDs) for the prevention of vascular complications in an all-comers transfemoral percutaneous coronary intervention (PCI) population. A total of 8,292 consecutive PCI patients were enrolled from a single-centre prospective registry from January 2005 to December 2010. VCDs were available from July 2007 and, from that time point, VCDs were implanted in 1,780 of the 5,394 patients (33%). Vascular complications occurred in 221 (2.7%) patients. The use of VCDs was independently associated with a 53% risk reduction (OR 0.47, 95% CI: 0.3-0.7) in vascular complications (3.0% vs. 1.5%) and with a 65% risk reduction (IRR 0.37, 95% CI: 0.32-0.43) in the post-PCI length of hospital stay (LOS) (mean 2.8 vs. 1.5 days). Mainly due to the reduced LOS, the patients with VCDs accrued vascular direct medical costs (VCD, diagnosis and treatment of vascular complications, post-PCI LOS) that were on average 498€ less than those accrued by the non-VCD patients. The cost-effectiveness was present across all vascular risk profiles. In this large, all-comers transfemoral PCI population, the use of VCDs was independently associated with a reduction in the rate of vascular complications and the post-PCI length of hospital stay and proved to be cost-saving across all vascular risk profiles.

  3. Impact of sheath diameter of different sheath types on vascular complications and mortality in transfemoral TAVI approaches using the Proglide closure device

    PubMed Central

    Dimitriadis, Zisis; Scholtz, Werner; Ensminger, Stephan M.; Piper, Cornelia; Bitter, Thomas; Wiemer, Marcus; Vlachojannis, Marios; Börgermann, Jochen; Faber, Lothar; Horstkotte, Dieter; Gummert, Jan; Scholtz, Smita

    2017-01-01

    Objective Evaluation of the impact of the sheath diameter on vascular complications and mortality in transfemoral aortic valve implantation. Method Between 2012 and 2014, 183 patients underwent the procedure using a sheath diameter of 18–24 F. This collective was divided into two groups: group 1, with a sheath diameter of 18F (G1, n = 94), consisted of patients with 18F Medtronic Sentrant and 18 F Direct Flow sheaths, and group 2 with a sheath diameter of 19–24 F (G2, n = 89) consisted of patients with Edwards expandable e-sheath and Solopath sheaths. Perclose-Proglide® was used as a closure device in all patients. Results G1 had significantly more female patients (64.9% vs. 46.1% in G2, p = 0.01) and the average BMI was lower (26 ± 4.5% vs. 27.4 ± 4.7%, p = 0.03). There was no significant difference in the incidence of major and minor vascular complications (G1: 12.8% vs. G2: 12.4%, p = 0.9). 30-day mortality was similar in both groups (G1: 6.4 ± 2.5% [95% CI: 0.88–0.98], G2: 3.7 ± 1.9% [95% CI: 0.92–0.99]. The Kaplan Meier analysis of survival revealed no significant differences either. Conclusion The difference in sheath diameter had no effect on either incidence or severity of vascular complications. There was no impact on mortality either. PMID:28837613

  4. Analysis of Alfvén eigenmode destabilization by energetic particles in Large Helical Device using a Landau-closure model

    DOE PAGES

    Varela, Jacobo Rodriguez; Spong, D. A.; Garcia, L.

    2017-03-06

    Here, energetic particle populations in nuclear fusion experiments can destabilize the Alfvén Eigenmodes through inverse Landau damping and couplings with gap modes in the shear Alfvén continua. We use the reduced MHD equations to describe the linear evolution of the poloidal flux and the toroidal component of the vorticity in a full 3D system, coupled with equations of density and parallel velocity moments for the energetic particles. We add the Landau damping and resonant destabilization effects using a closure relation. We apply the model to study the Alfvén mode stability in the inward-shifted configurations of the Large Helical Device (LHD), performing a parametric analysis of the energetic particle β (more » $${{\\beta}_{f}}$$ ) in a range of realistic values, the ratios of the energetic particle thermal/Alfvén velocities ($${{V}_{\\text{th}}}/{{V}_{A0}}$$ ), the magnetic Lundquist numbers (S) and the toroidal modes (n). The n = 1 and n = 2 TAEs are destabilized, although the n = 3 and n = 4 TAEs are weakly perturbed. The most unstable configurations are associated with the density gradients of energetic particles in the plasma core: the TAEs are destabilized, even for small energetic particle populations, if their thermal velocity is lower than 0.4 times the Alfvén velocity. The frequency range of MHD bursts measured in the LHD are 50–70 kHz for the n = 1 and 60–80 kHz for the n = 2 TAE, which is consistent with the model predictions.« less

  5. Duct closure

    DOEpatents

    Vowell, Kennison L.

    1987-01-01

    A closure for an inclined duct having an open upper end and defining downwardly extending passageway. The closure includes a cap for sealing engagement with the open upper end of the duct. Associated with the cap are an array of vertically aligned plug members, each of which has a cross-sectional area substantially conforming to the cross-sectional area of the passageway at least adjacent the upper end of the passageway. The plug members are interconnected in a manner to provide for free movement only in the plane in which the duct is inclined. The uppermost plug member is attached to the cap means and the cap means is in turn connected to a hoist means which is located directly over the open end of the duct.

  6. Endoscopic clip closure of gastrointestinal perforations, fistulae, and leaks.

    PubMed

    Raju, Gottumukkala S

    2014-01-01

    Development of endoscopic devices to close perforations has certainly revolutionized endoscopy. Immediate closure of perforations eliminates the need for surgery, which allows us to push the limits of endoscopic surgery from the mucosal plane to deep submucosal layers and eventually transmurally. The present article focuses on endoscopic closure devices, closure techniques, followed by a review of animal and clinical studies on endoscopic closure of perforations. © 2013 The Author. Digestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society.

  7. Safety and efficacy of device closure for patent foramen ovale for secondary prevention of neurological events: Comprehensive systematic review and meta-analysis of randomized controlled trials.

    PubMed

    Hakeem, Abdul; Marmagkiolis, Konstantinos; Hacioglu, Yalcin; Uretsky, Barry F; Gundogdu, Betul; Leesar, Massoud; Bailey, Steven R; Cilingiroglu, Mehmet

    2013-01-01

    Controversy persists regarding the management of patients with cryptogenic stroke and patent foramen ovale (PFO). We performed a meta-analysis of randomized controlled trials comparing PFO closure with medical therapy. A prospective protocol was developed and registered using the following data sources: PubMed, Cochrane Register of Controlled Trials, conference proceedings, and Internet-based resources of clinical trials. Primary analyses were performed using the intention-to-treat method. Three randomized trials comparing percutaneous PFO closure vs. medical therapy for secondary prevention of embolic neurological events formed the data set. Baseline characteristics were similar. During long-term follow-up, the pooled incidence of the primary endpoint (composite of stroke, death, or fatal stroke) was 3.4% in the PFO closure arm and 4.8% in the medical therapy group [risk-reduction (RR) 0.7 (0.48-1.06); p=0.09]. The incidence of recurrent neurological events (secondary endpoint) was 1.7% for PFO closure and 2.7% for medical therapy [RR 0.66 (0.35-1.24), p=0.19]. There was no difference in terms of death or adverse events between the two groups. While this meta-analysis of randomized clinical trials demonstrated no statistical significance in comparison to medical therapy, there was a trend towards overall improvement in outcomes in the PFO closure group. © 2013.

  8. A prospective randomized trial comparing subatmospheric wound therapy with a sealed gauze dressing and the standard vacuum-assisted closure device.

    PubMed

    Dorafshar, Amir H; Franczyk, Mieczyslawa; Gottlieb, Lawrence J; Wroblewski, Kristen E; Lohman, Robert F

    2012-07-01

    Two methods of subatmospheric pressure wound therapy--wall suction applied to a sealed gauze dressing (GSUC) and the vacuum-assisted closure device (VAC)--were compared in hospitalized patients at University of Chicago Medical Center. VAC therapy is widely used, but can be expensive and difficult to apply; it also fails in some patients. A randomized prospective study of 87 patients (N = 45 in the GSUC arm and N = 42 in the VAC arm) was undertaken between October 2006 and May 2008. The study comprised patients with acute wounds resulting from trauma, dehiscence, or surgery. Demographics and wound characteristics were similar in both groups. There were significant reductions in wound surface area and volume in each group. In the GSUC group, the reductions in wound surface area and volume were 4.5%/day and 8.4%/day, respectively (P < 0.001 for both), and in the VAC group, this was 4.9%/day and 9.8%/day, respectively (P < 0.001 for both). The reductions in wound surface area and volume were similar in both groups (P = 0.60 and 0.19, respectively, for the group-by-time interaction). The estimated difference (VAC - GSUC) was 0.4% (95% confidence interval: -1.0, 1.7) for wound surface area and 1.4% (95% confidence interval: -0.7, 3.5) for volume. The mean cost per day for GSUC therapy was $4.22 versus $96.51 for VAC therapy (P < 0.01) and the average time required for a GSUC dressing change was 19 minutes versus 31 minutes for a VAC dressing change (P < 0.01). The sum of pain intensity differences was 0.50 in the GSUC group compared with 1.73 for the VAC group (P = 0.02). GSUC is noninferior to VAC with respect to changes in wound volume and surface area in an acute care setting. In addition, GSUC dressings were easier to apply, less expensive, and less painful.

  9. 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.

  10. 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.

  11. Titanium Plug Closure after HeartWare Ventricular Assist Device Explantation in a 15-Year-Old Girl: First U.S. Experience

    PubMed Central

    Jeewa, Aamir; Elias, Barbara A.; McCullum, Elizabeth O.; Denfield, Susan W.; Dreyer, William J.; Adachi, Iki

    2017-01-01

    We describe the case of a teenage girl with anthracycline-induced cardiomyopathy who received a HeartWare ventricular assist device and underwent successful device explantation after cardiac recovery. During device support, the patient's cardiac function returned to normal. Twelve months after implantation, we explanted the device via repeat median sternotomy. To close the hole in the left ventricular apex and preserve the sewing ring in case future device support is needed, we used a German-manufactured titanium plug, developed specifically for this purpose. To our knowledge, this is the first use of this plug in the United States. The patient recovered uneventfully and was discharged from the hospital on postoperative day 11. Left ventricular biopsy specimens at explantation revealed the resolution of previous degenerative sarcomeric changes. Our patient did well clinically; however, recurrent late anthracycline cardiotoxicity might subsequently cause her cardiac function to deteriorate. In this event, our use of the titanium plug to preserve the left ventricular sewing ring would enable easier device replacement than would other explantation options. PMID:28265217

  12. Closure of the open abdomen.

    PubMed

    Björck, Martin; D'Amours, Scott K; Hamilton, A E Ricardo

    2011-07-01

    The open abdomen is a valuable tool in the management of patients with intra-abdominal hypertension and abdominal compartment syndrome. The longer an abdomen is left open, the greater the potential morbidity, however. From the very start, specific measures should be considered to increase the likelihood of definitive closure and prevent the development of visceral adhesions, lateralization, and/or loss of skin and fascia, ileus, fistulae, and malnutrition. Early definitive closure of all abdominal wall layers is the short-term goal of management once the need for the open abdomen has resolved. Several devices and strategies improve the chances for definitive closure. If a frozen abdomen develops, split-thickness skin grafting of a granulating open abdominal wound base is an alternative. Early coverage of the exposed viscera and acceptance of a large abdominal hernia permit earlier reversal of the catabolic state and lower the risk of fistula formation. When a stoma is required, sealing and separation can become problematic. If a fistula develops, a more complex situation prevails, requiring specific techniques to isolate its output and a longer-term strategy to restore intestinal continuity. Planning the closure of an open abdomen is a process that starts on the first day that the abdomen is opened. Multiple factors need to be addressed, optimized, and controlled to achieve the best outcome.

  13. Patent ductus venosus presenting with cholestatic jaundice in an infant with successful trans-catheter closure using a vascular plug device

    PubMed Central

    Chacko, Anith; Kock, Celeste; Joshi, Jayneel A; Mitchell, Lindi; Ahmad, Samia

    2016-01-01

    Persistent ductus venosus as a cause of cholestatic jaundice is very rare. Treatment varies, but is usually reserved for infants in whom complications develop. We report a 5-week-old female infant with cholestatic jaundice caused by a patent ductus venosus and subsequent successful treatment via a transcatheter occlusion using a vascular plug device. PMID:27857466

  14. 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.

  15. 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

  16. Closure of Bronchopleural Fistula with Angio-Seal

    SciTech Connect

    Pianta, Marcus; Vargas, Patricio; Niedmann, Juan; Lyon, Stuart

    2011-02-15

    Bronchopleural fistula is rare and occurs most often after trauma or surgery. Conservative management and support comprise the initial treatment, but if unsuccessful, surgical closure is usually required. We describe for what is to our knowledge the first successful use of an Angio-Seal vascular closure device in a patient who was not a candidate for surgery.

  17. Surgical strategies and novel alternatives for the closure of ventricular septal defects.

    PubMed

    Holzer, Ralf J; Sallehuddin, Ahmad; Hijazi, Ziyad M

    2016-07-01

    A variety of therapies are available to close ventricular septal defects (VSDs). These include surgical closure on bypass, percutaneous device closure, as well as perventricular hybrid closure. Due to the incidence of heart block (1-5%) associated with percutaneous device closure of perimembranous VSDs, surgical closure presently remains the gold standard and preferred therapy for these defects. Therapeutic options are more varied for muscular VSDs. Beyond infancy, transcatheter closure offers excellent results with low morbidity and mortality, without the need for cardiopulmonary bypass. Infants however have a higher incidence of adverse events using a percutaneous approach. Large mid-muscular VSDs in infants can be treated successfully using a hybrid approach, surgical closure on bypass or a percutaneous approach. However, VSDs located apically or anteriorly are difficult to identify surgically and for these infants, perventricular hybrid closure should be considered as the preferred therapeutic modality. However, some VSD's also can be closed percutaneously.

  18. Failed exstrophy closure.

    PubMed

    Novak, Thomas E

    2011-05-01

    Children with bladder exstrophy present a formidable surgical challenge. Like all major reconstructive surgeries, the best hope for a favorable outcome lies in achieving success in the first operative attempt. Regardless of the surgical approach, however, complications do occur. A failed exstrophy closure is a major complication with significant implications on the long-term surgical outcome and ultimate fate of the urinary tract. Successful repeat exstrophy closure can be accomplished in most cases when performed in conjunction with pelvic osteotomy and proper postoperative immobilization. Modern staged repair of exstrophy, complete primary repair of exstrophy, and immediate continent urinary diversion have been advocated by different groups in the management of a failed exstrophy closure. It is apparent that compared with children who undergo successful primary closure, a failed closure with subsequent successful repeat closure makes the child much less likely to achieve sufficient bladder growth to be considered for bladder neck reconstruction, and furthermore, makes them less likely to have a successful bladder neck reconstruction even when they are an acceptable candidate. Although acceptable dryness rates after repeat closure can ultimately be obtained, they are typically at the expense of a commitment to intermittent catheterization and continent diversion. Published by Elsevier Inc.

  19. Too much vacuum-assisted closure.

    PubMed

    Dieu, Tam; Leung, Michael; Leong, James; Morrison, Wayne; Cleland, Heather; Archer, Brett; Oppy, Andrew

    2003-12-01

    There has been an explosion in the use of the vacuum-assisted closure device since 1997. Selectively and judiciously used, it is a valuable tool. However, we are concerned by the expanding list of 'indications' for its use. Prolonged applications, frequently several weeks, at the expense of early surgical reconstruction, might compromise the outcome in selected cases. We report four cases that illustrate this problem and stress the importance of timely surgical reconstruction utilizing the range of reconstructive techniques available as well as vacuum-assisted closure dressing.

  20. Comparison of a vascular closure device versus the radial approach to reduce access site complications in non-ST-segment elevation acute coronary syndrome patients: The angio-seal versus the radial approach in acute coronary syndrome trial.

    PubMed

    Andrade, Pedro B; Mattos, Luiz A; Rinaldi, Fábio S; Bienert, Igor C; Barbosa, Robson A; Labrunie, André; Tebet, Marden; Esteves, Vinícius; Abizaid, Alexandre; Sousa, Amanda R

    2017-05-01

    To compare the radial versus femoral approach using Angio-Seal for the incidence of access site complications among non-ST-segment elevation acute coronary syndrome patients undergoing invasive strategy. Arterial access is a major site of complications after invasive coronary procedures. Vascular closure devices provide more comfort to patients decreasing time to 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. Single-center non-inferiority trial where 240 patients were randomized to radial or femoral access using Angio-Seal. The primary objective was the occurrence of complications at the arterial puncture site until 30 days after the procedure. There were no baseline clinical differences between groups, except for a greater prevalence of female patients in the radial group (33.3 vs. 20.0%, P = 0.020). Hemostasis was achieved in the entire radial group with the use of TR Band and in 95% of the procedures in the femoral group with Angio-Seal (P = 0.029). Except for a higher incidence of asymptomatic arterial occlusion in the radial group, there were no differences among the other analyzed outcomes. According to the noninferiority test, the use of Angio-Seal was noninferior to the radial approach, considering the margin of 15% (12.5 vs. 13.3%, difference -0.83%, 95% CI -9.31 - 7.65, P for noninferiority <0.001). Angio-Seal seems noninferior in the incidence of access site complications at 30 days when compared with the radial approach. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  1. Sternal exploration or closure

    MedlinePlus

    ... Chronic pain Decreased lung function Increased risk of death More infections Need to repeat or revise the procedure Alternative Names VAC - vacuum-assisted closure - sternal wound; Sternal dehiscence; Sternal infection References ...

  2. Quick actuating closure

    NASA Technical Reports Server (NTRS)

    White, III, Dorsey E. (Inventor); Updike, deceased, Benjamin T. (Inventor); Allred, Johnny W. (Inventor)

    1989-01-01

    A quick actuating closure for a pressure vessel 80 in which a wedge ring 30 with a conical outer surface 31 is moved forward to force shear blocks 40, with conical inner surfaces 41, radially outward to lock an end closure plug 70 within an opening 81 in the pressure vessel 80. A seal ring 60 and a preload ramp 50 sit between the shear blocks 40 and the end closure plug 70 to provide a backup sealing capability. Conical surfaces 44 and 55 of the preload ramp 50 and the shear blocks 40 interact to force the seal ring 60 into shoulders 73 and 85 in the end closure plug 70 and opening 81 to form a tight seal. The end closure plug 70 is unlocked by moving the wedge ring 30 rearward, which causes T-bars 32 of the wedge ring 30 riding within T -slots 42 of the shear blocks 40 to force them radially inward. The end closure plug 70 is then removed, allowing access to the interior of the pressure vessel 80.

  3. Incomplete RV Remodeling After Transcatheter ASD Closure in Pediatric Age.

    PubMed

    Agha, Hala M; El-Saiedi, Sonia A; Shaltout, Mohamed F; Hamza, Hala S; Nassar, Hayat H; Abdel-Aziz, Doaa M; Tantawy, Amira Esmat El

    2015-10-01

    Published data showing the intermediate effect of transcatheter device closure of atrial septal defect (ASD) in the pediatric age-group are scarce. The objective of the study was to assess the effects of transcatheter ASD closure on right and left ventricular functions by tissue Doppler imaging (TDI). The study included 37 consecutive patients diagnosed as ASD secundum by transthoracic echocardiography and TEE and referred for transcatheter closure at Cairo University Specialized Pediatric Hospital, Egypt, from October 2010 to July 2013. Thirty-seven age- and sex-matched controls were selected. TDI was obtained using the pulsed Doppler mode, interrogating the right cardiac border (the tricuspid annulus) and lateral mitral annulus, and myocardial performance index (MPI) was calculated at 1-, 3-, 6- and 12-month post-device closure. Transcatheter closure of ASD and echocardiographic examinations were successfully performed in all patients. There were no significant differences between two groups as regards the age, gender, weight or BSA. TDI showed that patients with ASD had significantly prolonged isovolumetric contraction, relaxation time and MPI compared with control group. Decreased tissue Doppler velocities of RV and LV began at one-month post-closure compared with the controls. Improvement in RVMPI and LVMPI began at 1-month post-closure, but they are still prolonged till 1 year. Reverse remodeling of right and left ventricles began 1 month after transcatheter ASD closure, but did not completely normalize even after 1 year of follow-up by tissue Doppler imaging.

  4. 33 CFR 155.805 - Closure devices.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) POLLUTION OIL OR HAZARDOUS MATERIAL POLLUTION PREVENTION REGULATIONS FOR VESSELS Transfer Personnel... valves, wafer-type resilient seated valves, blank flanges, or other means acceptable to the COTP or OCMI...

  5. Barbed suture for gastrointestinal closure: a randomized control trial.

    PubMed

    Demyttenaere, Sebastian V; Nau, Peter; Henn, Matthew; Beck, Catherine; Zaruby, Jeffrey; Primavera, Michael; Kirsch, David; Miller, Jeffrey; Liu, James J; Bellizzi, Andrew; Melvin, W Scott

    2009-09-01

    In an effort to make laparoscopic suturing more efficient, the V-Loc advanced wound closure device (Covidien, Mansfield, MA) has been produced. This device is a self-anchoring barbed suture that obviates the need for knot tying. The goal of this initial feasibility study was to investigate the use of the barbed suture in gastrointestinal enterotomy closure. A randomized study of 12 pigs comparing enterotomy closure with barbed versus a nonbarbed suture of similar tensile strength was performed. To this end, 25 mm enterotomies were made in the stomach (1 control, 1 treatment), jejunum (2 controls, 2 treatments), and descending colon (1 control, 1 treatment). Animals were killed at 3, 7, and 14 days postoperatively (4 each group) and their gastrointestinal tracts harvested; 6 of the 8 enterotomies from each pig underwent burst strength testing. The remaining 2 were fixed in formalin and sent for histological examination. All 12 pigs survived until they were killed without any major complications. Enterotomy closure with barbed suture revealed adhesion scores, burst strength pressures, and histology scores that were similar to those for the control. Jejunal closures resulted in 6 failures at 7 days (3 control, 3 barbed) and 4 failures at 14 days (2 control, 2 barbed). The barbed suture significantly reduced suturing time in the stomach, jejunum, and colon. The V-Loc wound closure device appears to offer comparable gastrointestinal closure to 3-0 Maxon while being significantly faster. Further studies with V-Loc are required to assess its use in laparoscopic surgery.

  6. Reaching closure with skin stretching. Applications in the diabetic foot.

    PubMed

    Armstrong, D G; Wunderlich, R P; Lavery, L A

    1998-01-01

    At the present time, there are no evidence-based protocols outlining the use of the Sure-Closure Skin Stretching System on diabetic, neuropathic wounds. Ideally, surgical correction of the precipitating deformity and appropriate shoe gear accommodation should be performed con-comitantly with skin stretching (as indicated) to achieve an optimal long-term result. For several years, we have used the Sure-Closure device as an adjunctive treatment for diabetic-foot wound closure, and believe that, ultimately, this device more likely will be used in a clinical setting. In this manner, a patient with an open wound may, under aseptic conditions, be sequestered for a period of 1 to 2 hours during a clinical visit to allow for skin stretching. This procedure may be carried out two or three times weekly until closure is achieved. Mechanically assisted delayed primary closure is a relatively new category of wound closure; however, this device is by no means a panacea. Appropriate patient selection and intraoperative judgment are of critical preoperative and perioperative importance when employing this technique. Currently, we are completing a clinical trial comparing mechanically assisted delayed primary-wound closure to traditional treatment and off-loading in a population of high-risk diabetic patients. We believe that this project will better elucidate the relative indications and contraindications with what may be a very effective tool for the diabetic foot specialist.

  7. The Queen's closure: a novel technique for closure of endoscopic gastrotomy for natural-orifice transluminal endoscopic surgery.

    PubMed

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

    2009-02-01

    Finding a reliable, safe, adaptable method of closing gastrotomies for natural-orifice transluminal endoscopic surgery (NOTES) procedures has been a major challenge facing this new clinical area. The Queen's NOTES Group has designed a novel endoscopic method of closing gastrotomies which involved using PolyLoop polyp ligature devices and endoscopic clips. The current study describes the technique and a pilot study of leak testing it versus hand-sewn suture closure. Ten fresh pig stomachs were used, five for each technique. A 16-mm endoscopic gastrotomy was performed on the anterior wall of each. Five stomachs were then closed using the Queen's closure technique, and five with a hand-sewn double-layer suture technique. The stomachs were then connected to a water infusion device with sensitive pressure monitoring and were filled until leakage was detected at the closure site. The closures were all technically successful. The mean time for each gastrotomy and closure using the Queen's closure technique was 1.2 hours. The mean leak pressure for the Queen's closure was 51.8 mmHg and for the hand-sewn suture technique it was 80.8 mmHg ( P < 0.001). The Queen's closure technique holds promise as a reliable transferable technique for closing gastrotomies. Further study is necessary to evaluate its effects in live models.

  8. Transcatheter closure of post-myocardial infarction ventricular septal rupture.

    PubMed

    Assenza, Gabriele Egidy; McElhinney, Doff B; Valente, Anne Marie; Pearson, Disty D; Volpe, Massimo; Martucci, Giuseppe; Landzberg, Michael J; Lock, James E

    2013-02-01

    Ventricular septal rupture (VSR) after acute myocardial infarction (AMI) is a potentially lethal mechanical complication of acute coronary syndromes. Given high surgical mortality, transcatheter closure has emerged as a potential strategy in selected cases. We report our single-center experience with double-umbrella device percutaneous closure of post-AMI VSR. In this single-center, retrospective, cohort study, patients who underwent transcatheter closure of post-AMI VSR between 1988 and 2008 at Boston Children's Hospital were included. Data were analysed according to whether the patients underwent direct percutaneous VSR closure or closure of a residual VSR after a previous surgical approach. Primary outcome was mortality rate at 30 days. Clinical predictors of primary outcome were investigated using univariate logistic regression. Thirty patients were included in the study (mean age, 67±8 years). A total of 40 closure devices were implanted. Major periprocedural complications occurred in 4 (13%) patients. Cardiogenic shock, increasing pulmonary/systemic flow ratio, and the use of the new generation (6-arm) STARFlex device all were associated with higher risk of mortality. The Model for End-Stage Liver Disease Excluding international normalized ratio (MELD-XI) score at the time of VSR closure seemed to be most strongly associated with death (odds ratio, 1.6; confidence interval, 1.1-2.2; P<0.001). Transcatheter closure of post-AMI VSR using CardioSEAL or STARFlex devices is feasible and effective. The MELD-XI score, a marker of multiorgan dysfunction, is a promising risk stratifier in this population of patients. Early closure of post-AMI VSR is advisable before establishment of multiorgan failure.

  9. Prolonged Eyelid Closure Episodes during Sleep Deprivation in Professional Drivers

    PubMed Central

    Alvaro, Pasquale K.; Jackson, Melinda L.; Berlowitz, David J.; Swann, Philip; Howard, Mark E.

    2016-01-01

    Study Objectives: Real life ocular measures of drowsiness use average blink duration, amplitude and velocity of eyelid movements to reflect drowsiness in drivers. However, averaged data may conceal the variability in duration of eyelid closure episodes, and more prolonged episodes that indicate higher levels of drowsiness. The current study aimed to describe the frequency and duration of prolonged eyelid closure episodes during acute sleep deprivation. Methods: Twenty male professional drivers (mean age ± standard deviation = 41.9 ± 8.3 years) were recruited from the Transport Workers Union newsletter and newspaper advertisements in Melbourne, Australia. Each participant underwent 24 hours of sleep deprivation and completed a simulated driving task (AusEd), the Psychomotor Vigilance Task, and the Karolinska Sleepiness Scale. Eyelid closure episodes during the driving task were recorded and analyzed manually from digital video recordings. Results: Eyelid closure episodes increased in frequency and duration with a median of zero s/h of eyelid closure after 3 h increasing to 34 s/h after 23 h awake. Eyelid closure episodes were short and infrequent from 3 to 14 h of wakefulness. After 17 h of sleep deprivation, longer and more frequent eyelid closure episodes began to occur. Episodes lasting from 7 seconds up to 18 seconds developed after 20 h of wakefulness. Length of eyelid closure episodes was moderately to highly correlated with the standard deviation of lateral lane position, braking reaction time, crashes, impaired vigilance, and subjective sleepiness. Conclusions: The frequency and duration of episodes of prolonged eyelid closure increases during acute sleep deprivation, with very prolonged episodes after 17 hours awake. Automated devices that assess drowsiness using averaged measures of eyelid closure episodes need to be able to detect prolonged eyelid closure episodes that occur during more severe sleep deprivation. Citation: Alvaro PK, Jackson ML

  10. Spontaneous closure of stoma.

    PubMed

    Pandit, Narendra; Singh, Harjeet; Kumar, Hemanth; Gupta, Rajesh; Verma, G R

    2016-11-01

    Intestinal loop stoma is a common surgical procedure performed for various benign and malignant abdominal problems, but it rarely undergoes spontaneous closure, without surgical intervention. Two male patients presented to our emergency surgical department with acute abdominal pain. One of them was diagnosed as having rectosigmoid perforation and underwent diversion sigmoid loop colostomy after primary closure of the perforation. The other was a known case of carcinoma of the rectum who had already undergone low anterior resection with covering loop ileostomy; the patient underwent second loop ileostomy, this time for complicated intestinal obstruction. To our surprise, both the loop colostomy and ileostomy closed spontaneously at 8 weeks and 6 weeks, respectively, without any consequences. Spontaneous stoma closure is a rare and interesting event. The exact etiology for spontaneous closure remains unknown, but it may be hypothesized to result from slow retraction of the stoma, added to the concept of a tendency towards spontaneous closure of enterocutaneous fistula. © The Author(s) 2015. Published by Oxford University Press and the Digestive Science Publishing Co. Limited.

  11. The myth of closure.

    PubMed

    Boss, Pauline; Carnes, Donna

    2012-12-01

    Therapies for grief and loss have traditionally focused on the work of grieving. The goal was to reach an endpoint, now popularly called closure. There are, however, many people who, through no fault of their own, find a loss so unclear that there can be no end to grief. They have not failed in the work of grieving, but rather have suffered ambiguous loss, a type of loss that is inherently open ended. Instead of closure, the therapeutic goal is to help people find meaning despite the lack of definitive information and finality. Hope lies in increasing a family's tolerance for ambiguity, but first, professionals must increase their own comfort with unanswered questions. In this article, the authors, one a poet, the other a family therapist and theorist, offer a unique blending of theory, reflection, and poetry to experientially deepen the process of self-reflection about a kind of loss that defies closure. © FPI, Inc.

  12. Achieving closure at Fernald

    SciTech Connect

    Bradburne, John; Patton, Tisha C.

    2001-02-25

    When Fluor Fernald took over the management of the Fernald Environmental Management Project in 1992, the estimated closure date of the site was more than 25 years into the future. Fluor Fernald, in conjunction with DOE-Fernald, introduced the Accelerated Cleanup Plan, which was designed to substantially shorten that schedule and save taxpayers more than $3 billion. The management of Fluor Fernald believes there are three fundamental concerns that must be addressed by any contractor hoping to achieve closure of a site within the DOE complex. They are relationship management, resource management and contract management. Relationship management refers to the interaction between the site and local residents, regulators, union leadership, the workforce at large, the media, and any other interested stakeholder groups. Resource management is of course related to the effective administration of the site knowledge base and the skills of the workforce, the attraction and retention of qualified a nd competent technical personnel, and the best recognition and use of appropriate new technologies. Perhaps most importantly, resource management must also include a plan for survival in a flat-funding environment. Lastly, creative and disciplined contract management will be essential to effecting the closure of any DOE site. Fluor Fernald, together with DOE-Fernald, is breaking new ground in the closure arena, and ''business as usual'' has become a thing of the past. How Fluor Fernald has managed its work at the site over the last eight years, and how it will manage the new site closure contract in the future, will be an integral part of achieving successful closure at Fernald.

  13. Tank closure reducing grout

    SciTech Connect

    Caldwell, T.B.

    1997-04-18

    A reducing grout has been developed for closing high level waste tanks at the Savannah River Site in Aiken, South Carolina. The grout has a low redox potential, which minimizes the mobility of Sr{sup 90}, the radionuclide with the highest dose potential after closure. The grout also has a high pH which reduces the solubility of the plutonium isotopes. The grout has a high compressive strength and low permeability, which enhances its ability to limit the migration of contaminants after closure. The grout was designed and tested by Construction Technology Laboratories, Inc. Placement methods were developed by the Savannah River Site personnel.

  14. Ion parallel closures

    NASA Astrophysics Data System (ADS)

    Ji, Jeong-Young; Lee, Hankyu Q.; Held, Eric D.

    2017-02-01

    Ion parallel closures are obtained for arbitrary atomic weights and charge numbers. For arbitrary collisionality, the heat flow and viscosity are expressed as kernel-weighted integrals of the temperature and flow-velocity gradients. Simple, fitted kernel functions are obtained from the 1600 parallel moment solution and the asymptotic behavior in the collisionless limit. The fitted kernel parameters are tabulated for various temperature ratios of ions to electrons. The closures can be used conveniently without solving the kinetic equation or higher order moment equations in closing ion fluid equations.

  15. History of Sandia National Laboratories` auxiliary closure mechanisms

    SciTech Connect

    Weydert, J.C.; Ponder, G.M.

    1993-12-01

    An essential component of a horizontal, underground nuclear test setup at the Nevada Test Site is the auxiliary closure system. The massive gates that slam shut immediately after a device has been detonated allow the prompt radiation to pass, but block debris and hot gases from continuing down the tunnel. Thus, the gates protect experiments located in the horizontal line-of-sight steel pipe. Sandia National Laboratories has been the major designer and developer of these closure systems. This report records the history of SNL`s participation in and contributions to the technology of auxiliary closure systems used in horizontal tunnel tests in the underground test program.

  16. Epidermal closure regulates histolysis during mammalian (Mus) digit regeneration

    PubMed Central

    Simkin, Jennifer; Sammarco, Mimi C.; Dawson, Lindsay A.; Tucker, Catherine; Taylor, Louis J.; Van Meter, Keith

    2015-01-01

    Abstract Mammalian digit regeneration progresses through consistent stages: histolysis, inflammation, epidermal closure, blastema formation, and finally redifferentiation. What we do not yet know is how each stage can affect others. Questions of stage timing, tissue interactions, and microenvironmental states are becoming increasingly important as we look toward solutions for whole limb regeneration. This study focuses on the timing of epidermal closure which, in mammals, is delayed compared to more regenerative animals like the axolotl. We use a standard wound closure device, Dermabond (2‐octyl cyanoacrylate), to induce earlier epidermal closure, and we evaluate the effect of fast epidermal closure on histolysis, blastema formation, and redifferentiation. We find that fast epidermal closure is reliant upon a hypoxic microenvironment. Additionally, early epidermal closure eliminates the histolysis stage and results in a regenerate that more closely replicates the amputated structure. We show that tools like Dermabond and oxygen are able to independently influence the various stages of regeneration enabling us to uncouple histolysis, wound closure, and other regenerative events. With this study, we start to understand how each stage of mammalian digit regeneration is controlled. PMID:27499872

  17. Percutaneous closure of a prosthetic pulmonary paravalvular leak.

    PubMed

    Seery, Thomas J; Slack, Michael C

    2014-01-01

    Paravalvular leak following prosthetic valve surgery has the potential to cause serious complications such as hemolysis and congestive heart failure. Successful percutaneous closures of prosthetic mitral and aortic paravalvular leaks have been performed as an alternative to reoperation. This case represents the first known report of successful percutaneous closure of a prosthetic pulmonary paravalvular leak in an adult patient with a history of congenital heart disease using two muscular ventricular septal defect occluder devices. © 2013 Wiley Periodicals, Inc.

  18. ROCKET PORT CLOSURE

    DOEpatents

    Mattingly, J.T.

    1963-02-12

    This invention provides a simple pressure-actuated closure whereby windowless observation ports are opened to the atmosphere at preselected altitudes. The closure comprises a disk which seals a windowless observation port in rocket hull. An evacuated instrument compartment is affixed to the rocket hull adjacent the inner surface of the disk, while the outer disk surface is exposed to the atmosphere through which the rocket is traveling. The pressure differential between the evacuated instrument compartment and the relatively high pressure external atmosphere forces the disk against the edge of the observation port, thereby effecting a tight seai. The instrument compartment is evacuated to a pressure equal to the atmospheric pressure existing at the altitude at which it is desiretl that the closure should open. When the rocket reaches this preselected altitude, the inwardly directed atmospheric force on the disk is just equaled by the residual air pressure force within the instrument compartment. Consequently, the closure disk falls away and uncovers the open observation port. The separation of the disk from the rocket hull actuates a switch which energizes the mechanism of a detecting instrument disposed within the instrument compartment. (AE C)

  19. Leading a hospital closure.

    PubMed

    Lucey, Paula A

    2002-01-01

    Hospital closures have become more common. The challenges facing a nursing leader in this situation are complex and difficult. This author suggests that looking for new beginnings rather than focusing on endings created an approach to closing a public hospital. The article includes approaches to employee morale, staffing, and patient care.

  20. Ring closure in actin polymers

    NASA Astrophysics Data System (ADS)

    Sinha, Supurna; Chattopadhyay, Sebanti

    2017-03-01

    We present an analysis for the ring closure probability of semiflexible polymers within the pure bend Worm Like Chain (WLC) model. The ring closure probability predicted from our analysis can be tested against fluorescent actin cyclization experiments. We also discuss the effect of ring closure on bend angle fluctuations in actin polymers.

  1. Hospital closure and economic efficiency.

    PubMed

    Capps, Cory; Dranove, David; Lindrooth, Richard C

    2010-01-01

    We present a new framework for assessing the effects of hospital closures on social welfare and the local economy. While patient welfare necessarily declines when patients lose access to a hospital, closures also tend to reduce costs. We study five hospital closures in two states and find that urban hospital bailouts reduce aggregate social welfare: on balance, the cost savings from closures more than offset the reduction in patient welfare. However, because some of the cost savings are shared nationally, total surplus in the local community may decline following a hospital closure.

  2. Recommendations for managing hospital closure.

    PubMed

    van der Wal, R; Bouthillette, F; Havlovic, S J

    1998-01-01

    An acute care hospital was closed by the British Columbia Ministry of Health in 1993. A research study was conducted to investigate the ways closure of the hospital affected hospital employees and to identify ways to facilitate the closure/reorganization process. Unstructured interviews were conducted with 25 employees around the time of closure and six months after the closure. In the category Living with Closure, six themes arose from the qualitative analysis. They related to (1) provision of information; (2) effect of closure on the working environment and colleagues; (3) perceived stress; (4) recognition of one's worth; (5) provision of support services; and (6) the process of having a new job. The authors offer recommendations stemming from the analysis, which are intended to assist others planning for future hospital reorganizations or closures.

  3. Spacesuit torso closure

    NASA Technical Reports Server (NTRS)

    Webbon, B. W.; Vykukal, H. C. (Inventor)

    1978-01-01

    A simple, economical and reliable entry closure is described for joining opposite halves of a torso section for a pressure suit in a manner which simplifies self-donning. A single coupling joins coaxially aligned, axially separable, tubular segments of a hard spacesuit along an angulated zone of separation, adapted to be mated in an hermetrically sealing relation. A releasable C section clamp secures the members in their mated relationship.

  4. Patent foramen ovale closure to prevent secondary neurologic events.

    PubMed

    Jasper, Rosie; Blankenship, James C

    2017-07-03

    In October of 2016 the United States Food and Drug Administration approved the Amplatzer Patent Foramen Ovale (PFO) occluder device for use in patients with cryptogenic stroke, to reduce the risk of recurrent stroke. This event followed 15years of off-label use of atrial septal occluder devices, 3 randomized trials, and enormous controversy over the efficacy of this procedure. While none of the trials reached the primary endpoint needed to prove the efficacy of PFO closure in preventing recurrent stroke, meta-analyses and 5-year follow-up of 1 trial suggest that PFO closure decreases the risk of recurrent stroke, especially in sub-groups with large shunts and atrial septal aneurysms, and especially when the Amplatzer device (rather than other devices) is used. While the relative reduction in stroke associated with PFO closure is large (about 50%), the absolute reduction is low (1-2%) and must be balanced against complications of the procedure (about 3%). Thus, PFO closure is restricted to patients with cryptogenic stroke, and depends heavily on patients' personal preferences. Uncertainties about the etiology of stroke in patients with PFO and the efficacy of PFO closure cause a difficult problem for the internal medicine specialist. At one extreme the internist may wonder if every patient with a documented PFO should be referred to a cardiologist. At the other extreme, supported by specialty society guidelines, internists may conclude that PFO closure is rarely necessary. In this paper we review the current status of PFO closure and suggest a rational strategy for this procedure. Copyright © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

  5. 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.

  6. 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.

  7. Brochial stump closure techniques following pneumonectomy: A serial comparative study.

    PubMed Central

    Scott, R N; Faraci, R P; Hough, A; Chretien, P B

    1976-01-01

    Three methods of closing bronchial stumps were evaluated in 90 dogs undergoing left pneumonectomy:interrupted 3-0 silk sutures, interrupted 3-0 nylon sutures, and stapling with an automatic device. The dogs were sacrificed at 24 hours, 3, 5, 7, 10, and 14 days after pneumonectomy. Brochial stump leakage pressures and histological studies were performed on all specimens. Differences in the exudative reaction between silk and staple closures were significant on day 5(238.19+/- 23.28 SD PMN's/HPF in silk closures, 34.95+/- 20.37 SD PMN's/HPF in staple closures) and therafter(P less than 0.001). The reaction to nylon was intermediate between silk and staple. Collagen levels were highest at all periods for staple closures. Staple leakage pressures were greater than silk or nylon(day 5: 145.3 mm Hg +/- 64.9 SD in staple closures, 40.2 mm Hg +/- 15.4 SD in silk closures). These results have clinical relevance to the selection of suture materials for stump closures. Images Fig. 2. Fig. 3. Fig. 5. PMID:782390

  8. Effect of atrial septal mobility on transcatheter closure of interatrial communications.

    PubMed

    Scott, Nandita S; King, Mary Etta; McQuillan, Brendan; Shariff, Salima; Hung, Judy W; Januzzi, James L; Palacios, Igor F; Picard, Michael H

    2003-11-01

    Transcatheter techniques have evolved as alternatives to surgical closure of interatrial communications due to its less invasive nature and low morbidity. The technique may be limited by the inability to deploy the device and, thus, may be complicated by significant residual shunting. Mobile or redundant septal tissue has been implicated as a possible cause of unsuccessful closure. To determine if atrial septal hypermobility precludes successful transcatheter device closure of interatrial communications, 69 patients (mean age 46.4 +/- 17.5 years [male:female ratio 34:35]) with periprocedural transesophageal echocardiograms were reviewed. Septal excursion was defined as the maximal transit of the interatrial septum between either side of the plane connecting the superior and inferior attachment points. Unsuccessful closure was defined as subsequent cardiac surgery to close the defect, inability to deploy the device, recurrent attempts at closure, device malalignment, residual shunting greater than mild in degree on follow-up transthoracic study, and procedural complications. Reasons for closure were the following: embolic events (n = 48); platypnea/orthodeoxia (n = 15); atrial septal defect with right ventricular dilatation and paroxysmal atrial tachycardia (n = 2); atrial septal defect (n = 3); and prophylactic patent foramen ovale closure in a scuba diver (n = 1). Successful closure occurred in 76% of patients (n = 53). Compared with those patients with successful transcatheter closure, the mean septal excursion in patients with failed closure was 0.66 +/- 0.56 cm versus 0.76 +/- 0.47 cm (P = not significant [NS]). Our results do not support the concern that exaggerated septal mobility compromises successful device closure of interatrial communications.

  9. Orbiter door closure tools

    NASA Technical Reports Server (NTRS)

    Acres, W. R.

    1980-01-01

    Safe reentry of the shuttle orbiter requires that the payload bay doors be closed and securely latched. Since a malfunction in the door drive or bulkhead latch systems could make safe reentry impossible, the requirement to provide tools to manually close and secure the doors was implemented. The tools would disconnect a disabled door or latch closure system and close and secure the doors if the normal system failed. The tools required to perform these tasks have evolved into a set that consists of a tubing cutter, a winch, a latching tool, and a bolt extractor. The design, fabrication, and performance tests of each tool are described.

  10. System for closure of a physical anomaly

    SciTech Connect

    Bearinger, Jane P; Maitland, Duncan J; Schumann, Daniel L; Wilson, Thomas S

    2014-11-11

    Systems for closure of a physical anomaly. Closure is accomplished by a closure body with an exterior surface. The exterior surface contacts the opening of the anomaly and closes the anomaly. The closure body has a primary shape for closing the anomaly and a secondary shape for being positioned in the physical anomaly. The closure body preferably comprises a shape memory polymer.

  11. 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

  12. FINAL CLOSURE PLAN SURFACE IMPOUNDMENTS CLOSURE, SITE 300

    SciTech Connect

    Lane, J E; Scott, J E; Mathews, S E

    2004-09-29

    Lawrence Livermore National Laboratory of the University of California (LLNL) operates two Class II surface impoundments that store wastewater that is discharged from a number of buildings located on the Site 300 Facility (Site 300). The wastewater is the by-product of explosives processing. Reduction in the volume of water discharged from these buildings over the past several years has significantly reduced the wastewater storage needs. In addition, the impoundments were constructed in 1984, and the high-density polyethylene (HDPE) geomembrane liners are nearing the end of their service life. The purpose of this project is to clean close the surface impoundments and provide new wastewater storage using portable, above ground storage tanks at six locations. The tanks will be installed prior to closure of the impoundments and will include heaters for allowing evaporation during relatively cool weather. Golder Associates (Golder) has prepared this Final Closure Plan (Closure Plan) on behalf of LLNL to address construction associated with the clean closure of the impoundments. This Closure Plan complies with State Water Resources Control Board (SWRCB) Section 21400 of the California Code of Regulations Title 27 (27 CCR {section}21400). As required by these regulations and guidance, this Plan provides the following information: (1) A site characterization, including the site location, history, current operations, and geology and hydrogeology; (2) The regulatory requirements relevant to clean closure of the impoundments; (3) The closure procedures; and, (4) The procedures for validation and documentation of clean closure.

  13. Extender for securing a closure

    DOEpatents

    Thomas, II, Patrick A.

    2012-10-02

    An apparatus for securing a closure such as door or a window that opens and closes by movement relative to a fixed structure such as a wall or a floor. Many embodiments provide a device for relocating a padlock from its normal location where it secures a fastener (such as a hasp) to a location for the padlock that is more accessible for locking and unlocking the padlock. Typically an extender is provided, where the extender has a hook at a first end that is disposed through the eye of the staple of the hasp, and at an opposing second end the extender has an annulus, such as a hole in the extender or a loop or ring affixed to the extender. The shackle of the padlock may be disposed through the annulus and may be disposed through the eye of a second staple to secure the door or window in a closed or open position. Some embodiments employ a rigid sheath to enclose at least a portion of the extender. Typically the rigid sheath has an open state where the hook is exposed outside the sheath and a closed state where the hook is disposed within the sheath.

  14. Percutaneous closure of a very large left atrial appendage using the Amplatzer amulet.

    PubMed

    Freixa, Xavier; Kwai Chan, Jason Leung; Tzikas, Apostolos; Garceau, Patrick; Basmadjian, Arsène; Ibrahim, Réda

    2013-10-01

    Although percutaneous left atrial appendage (LAA) closure is becoming a common procedure worldwide, there are still some anatomic limitations. The size of the LAA is one of the current limitations as the most popular devices do not allow the closure of very large LAAs. The new Amplatzer Cardiac Plug 2, also called "Amulet," has been redesigned not only to improve delivery and safety but also to allow the closure of larger LAAs. The present report describes the successful closure of a very large LAA using the Amulet. Copyright © 2013 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  15. Nitinol clip distal migration and resultant popliteo-tibial artery occlusion complicating access closure by the StarClose SE vascular closure system.

    PubMed

    Choi, Dae Han; Kim, Myeong Jin; Yoo, Chan Jong; Park, Cheol Wan

    2017-02-01

    Lower extremity ischemia following deployment of a vascular closure device for access site closure after a transfemoral endovascular procedure rarely occurs. A 68-year-old woman diagnosed with subarachnoid hemorrhage due to a ruptured anterior communicating aneurysm was treated by endovascular coil embolization. The StarClose SE device was deployed for right femoral arteriotomy closure. After 2 days, critical ischemia occurred on her right lower leg due to total occlusion of the popliteo-tibial artery. Emergent surgical embolectomy was performed and the nitinol clip of the StarClose device was captured in the lumen of the tibioperoneal trunk. Although StarClose is an extravascular closure system, intravascular deployment, distal migration, and resultant critical limb ischemia can occur.

  16. Vacuum-assisted closure for the treatment of abdominal wounds.

    PubMed

    DeFranzo, Anthony J; Argenta, Louis

    2006-04-01

    Abdominal wall defects pose a significant surgical challenge. The defect may result from trauma, infections, previous major surgery, or some combination of these etiologies. This article describes the Vacuum-Assisted Closure device (VAC, KCI, San Antonio, Texas) and how it can help in treating these defects.

  17. Closedure - Mine Closure Technologies Resource

    NASA Astrophysics Data System (ADS)

    Kauppila, Päivi; Kauppila, Tommi; Pasanen, Antti; Backnäs, Soile; Liisa Räisänen, Marja; Turunen, Kaisa; Karlsson, Teemu; Solismaa, Lauri; Hentinen, Kimmo

    2015-04-01

    Closure of mining operations is an essential part of the development of eco-efficient mining and the Green Mining concept in Finland to reduce the environmental footprint of mining. Closedure is a 2-year joint research project between Geological Survey of Finland and Technical Research Centre of Finland that aims at developing accessible tools and resources for planning, executing and monitoring mine closure. The main outcome of the Closedure project is an updatable wiki technology-based internet platform (http://mineclosure.gtk.fi) in which comprehensive guidance on the mine closure is provided and main methods and technologies related to mine closure are evaluated. Closedure also provides new data on the key issues of mine closure, such as performance of passive water treatment in Finland, applicability of test methods for evaluating cover structures for mining wastes, prediction of water effluents from mine wastes, and isotopic and geophysical methods to recognize contaminant transport paths in crystalline bedrock.

  18. Evaluation of the Hall-effect sensor for determination of eyelid closure in vivo.

    PubMed

    Hamiel, S R; Bleicher, J N; Tubach, M R; Cronan, J C

    1995-07-01

    A small device to detect eyelid closure was designed on the basis of a Hall-effect sensor. Accurate sensing of normal eyelid closure is required to develop a prosthetic eyelid closure device for patients with paralyzed orbicularis oculi muscles. In this study, six rabbits had the sensors surgically implanted. A Hall-effect sensor, a small device that measures magnetic fields, was implanted in the inferior eyelid near the ciliary margin. An opposing magnet was implanted in the upper eyelid. Thus, as the eyelid closes, the output of the Hall-effect sensor will increase. This output voltage was monitored weekly. During the first 5 weeks the output of the Hall-effect sensor decreased slightly but then reached a steady state for the duration of the experiment. This study suggests that the Hall-effect sensor could be used to detect normal eyelid closure in an implantable facial reanimation device.

  19. Transcatether closure of an atrial redirection baffle leak

    PubMed Central

    Soriano, Brian D; Stout, Karen K; Cailes, Colleen D; Jones, Thomas K

    2009-01-01

    We present the case of a woman born with transposition of the great arteries, who was surgically repaired with the Mustard technique. Because of interatrial shunting, she was brought to the cardiac catheterization laboratory for device closure. Matrix-array 3D transesophageal echocardiography enabled visualization of both baffle leaks and demonstrated its orientation in a fashion superior to 2D imaging, had it been used alone. The leaks were successfully closed with a single transcatheter device. PMID:20300277

  20. Transcatether closure of an atrial redirection baffle leak.

    PubMed

    Soriano, Brian D; Stout, Karen K; Cailes, Colleen D; Jones, Thomas K

    2009-01-01

    We present the case of a woman born with transposition of the great arteries, who was surgically repaired with the Mustard technique. Because of interatrial shunting, she was brought to the cardiac catheterization laboratory for device closure. Matrix-array 3D transesophageal echocardiography enabled visualization of both baffle leaks and demonstrated its orientation in a fashion superior to 2D imaging, had it been used alone. The leaks were successfully closed with a single transcatheter device.

  1. Endobronchial closure of bronchopleural fistulas with Amplatzer vascular plug.

    PubMed

    Fruchter, Oren; Bruckheimer, Elchanan; Raviv, Yael; Rosengarten, Dror; Saute, Milton; Kramer, Mordechai R

    2012-01-01

    Bronchopulmonary fistula (BPF) is a severe complication following lobectomy or pneumonectomy and is associated with a high rate of morbidity and mortality. We have developed a novel minimally invasive method of central BPF closure using Amplatzer vascular plug (AVP) device that was originally designed for the transcatheter closure of vascular structures in patients with small BPF. Patients with BPFs were treated under conscious sedation by bronchoscopic closure of BPFs using AVP. After locating the fistula using bronchography, the self-expanding nitinol made AVP occluder to be delivered under direct bronchoscopic guidance over a loader wire into the fistula followed by bronchography to assure correct device positioning and sealing of the BPF. Six AVPs were placed in five patients, four males and one female, with a mean age of 62.3 years (range: 51-82 years). The underlying disorders and etiologies for BPF development were lobectomy (two patients), pneumonectomy for lung cancer (one patient), lobectomy due to necrotizing pneumonia (one patient), and post-tracheostomy tracheo-pleural fistula (one patient). In all the patients, the bronchoscopic procedure was successful and symptoms related to BPF disappeared following closure by the AVP. The results were maintained over a median follow-up of 9 months (range: 5-34 months). Endobronchial closure using the AVP is a safe and effective method for treatment of small postoperative BPF. The ease of their implantation by bronchoscopy under conscious sedation adds this novel technique to the armatorium of minimally invasive modalities for the treatment of small BPF.

  2. Spontaneous ileostomy closure

    PubMed Central

    Alyami, Mohammad S.; Lundberg, Peter W.; Cotte, Eddy G.; Glehen, Olivier J.

    2016-01-01

    Iatrogenic ileostomies are routinely placed during colorectal surgery for the diversion of intestinal contents to permit healing of the distal anastomosis prior to elective reversal. We present an interesting case of spontaneous closure of a diverting ileostomy without any adverse effects to the patient. A 65-year-old woman, positive for hereditary non-polyposis colorectal cancer type-I, with locally invasive cancer of the distal colon underwent en-bloc total colectomy, hysterectomy, and bilateral salpingoophorectomy with creation of a proximal loop ileostomy. The ostomy temporarily closed without reoperation at 10 weeks, after spontaneously reopening, it definitively closed, again without surgical intervention at 18 weeks following the original surgery. This rare phenomenon has occurred following variable colorectal pathology and is poorly understood, particularly in patients with aggressive disease and adjunct perioperative interventions. PMID:27279518

  3. CPT-hole closure

    USGS Publications Warehouse

    Noce, T.E.; Holzer, T.L.

    2003-01-01

    The long-term stability of deep holes 1.75 inches. (4.4 cm) in diameter by 98.4 feet (30 m) created by cone penetration testing (CPT) was monitored at a site in California underlain by Holocene and Pleistocene age alluvial fan deposits. Portions of the holes remained open both below and above the 28.6-foot (8.7 m)-deep water table for approximately three years, when the experiment was terminated. Hole closure appears to be a very slow process that may take decades in the stiff soils studied here. Other experience suggests holes in softer soils may also remain open. Thus, despite their small diameter, CPT holes may remain open for years and provide paths for rapid migration of contaminants. The observations confirm the need to grout holes created by CPT soundings as well as other direct-push techniques in areas where protection of shallow ground water is important.

  4. Hybrid closure of postinfarction ventricular septal rupture enlargement after transcathether closure with Amplatzer occluder.

    PubMed

    Jorge, Cláudia; de Oliveira, Eduardo Infante; Martins, Susana Robalo; Nobre, Angelo; da Silva, Pedro Canas; Diogo, António Nunes

    2012-04-01

    Ventricular septal rupture (VSR) is nowadays a rare complication of myocardial infarction (MI), but with a mortality rate still very high. Urgent surgical correction is recommended, although in specific cases percutaneous closure of a post-infarct VSR is a therapeutic option or a bridge to surgical correction. We report a case of an 80-year-old woman, with a subacute anterior MI with an antero-septal VSR. Rapid clinical deterioration in a high-surgical-risk patient led us to attempt percutaneous VSR closure at day 8 post MI. A 16-mm Amplatzer post-infarction (PI) muscular VSD closed the defect with intra-cardiac echocardiography guidance, that allowed conscious sedation. Clinical and haemodynamic improvement was immediate. Unfortunately, a small orifice distal to the device persisted, which enlarged to 8 mm over the following days, with a Qp/Qs shunt of 1.9. At day 17 post MI, the VSR was surgically closed by suturing the Amplatzer device to the septum. A residual shunt was evident, but with no progression, being the patient discharged in NYHA class I. Percutaneous closure of a post-MI VSR as a bridge to surgery is a therapeutic option in patients with high surgical risk, allowing haemodynamic stabilization and thus gaining time for a further surgical intervention if needed, improving these patients grim prognosis. Intra-cardiac echocardiography for monitoring the percutaneous procedure instead of a transoesophageal approach, as well as the surgical technique, make this case unique.

  5. Access and Hemostasis: Femoral and Popliteal Approaches and Closure Devices—Why, What, When, and How?

    PubMed Central

    Barbetta, Iacopo; van den Berg, Jos C.

    2014-01-01

    This article reviews the arterial access sites used in the treatment of peripheral arterial disease, including common femoral, superficial femoral, and popliteal arterial puncture. The optimal approach and techniques for arterial puncture will be described and technical tips and tricks will be discussed. An overview of the currently available vascular closure devices will also be presented. Indications, contraindications, and complications will be discussed. Results of the use of vascular closure devices compared with manual compression will be presented. PMID:25435661

  6. Angle closure in younger patients.

    PubMed Central

    Chang, Brian M; Liebmann, Jeffrey M; Ritch, Robert

    2002-01-01

    PURPOSE: Angle-closure glaucoma is rare in children and young adults. Only scattered cases associated with specific clinical entities have been reported. We evaluated the findings in patients in our database aged 40 or younger with angle closure. METHODS: Our database was searched for patients with angle closure who were 40 years old or younger. Data recorded included age at initial consultation; age at the time of diagnosis; gender; results of slit-lamp examination, gonioscopy, and ultrasound biomicroscopy (from 1993 onward); clinical diagnosis; and therapy. Patients with previous incisional surgery were excluded, as were patients with anterior chamber proliferative mechanisms leading to angle closure. RESULTS: Sixty-seven patients (49 females, 18 males) met entry criteria. Mean age (+/- SD) at the time of consultation was 34.4 +/- 9.4 years (range, 3-68 years). Diagnoses included plateau iris syndrome (35 patients), iridociliary cysts (8 patients), retinopathy of prematurity (7 patients), uveitis (5 patients), isolated nanophthalmos (3 patients), relative pupillary block (2 patients), Weill-Marchesani syndrome (3 patients), and 1 patient each with Marfan syndrome, miotic-induced angle closure, persistent hyperplastic primary vitreous, and idiopathic lens subluxation. CONCLUSION: The etiology of angle closure in young persons is different from that in the older population and is typically associated with structural or developmental ocular anomalies rather than relative pupillary block. Following laser iridotomy, these eyes should be monitored for recurrent angle closure and the need for additional laser or incisional surgical intervention. PMID:12545694

  7. Mixing in SRS Closure Business Unit Applications

    SciTech Connect

    POIRIER, MICHAELR.

    2004-06-23

    The following equipment is commonly used to mix fluids: mechanical agitators, jets (pumps), shrouded axial impeller mixers (Flygt mixers), spargers, pulsed jet mixers, boiling, static mixers, falling films, liquid sprays, and thermal convection. This discussion will focus on mechanical agitators, jets, shrouded axial impeller mixers, spargers, and pulsed jet mixers, as these devices are most likely to be employed in Savannah River Site (SRS) Closure Business applications. In addressing mixing problems in the SRS Tank Farm, one must distinguish between different mixing objectives. These objectives include sludge mixing (e.g., Extended Sludge Processing), sludge retrieval (e.g., sludge transfers between tanks), heel retrieval (e.g., Tanks 18F and 19F), chemical reactions (e.g., oxalic acid neutralization) and salt dissolution. For example, one should not apply sludge mixing guidelines to heel removal applications. Mixing effectiveness is a function of both the mixing device (e.g., slurry pump, agitator, air sparger) and the properties of the material to be mixed (e.g., yield stress, viscosity, density, and particle size). The objective of this document is to provide background mixing knowledge for the SRS Closure Business Unit personnel and to provide general recommendations for mixing in SRS applications.

  8. Usefulness of percutaneous closure of patent foramen ovale for hypoxia

    PubMed Central

    Munkres, Alyssa G.; Ball, Timothy N.; Chamogeorgakis, Themistokles; Ausloos, Kenneth A.; Hall, Shelley A.

    2015-01-01

    We report a patient with hypoxia secondary to a right-to-left shunt through a patent foramen ovale, following aortic root, valve, and arch replacement due to an aortic dissection in the setting of the Marfan syndrome. Following the operation, he failed extubation twice due to hypoxia. An extensive workup revealed a right-to-left shunt previously not seen. The patent foramen ovale was closed using a percutaneous closure device. Following closure, our patient was extubated without difficulty and has done well postoperatively. PMID:25829655

  9. Pulmonary edema following transcatheter closure of atrial septal defect

    PubMed Central

    Chigurupati, Keerthi; Reshmi, Liza Jose; Gadhinglajkar, Shrinivas; Venkateshwaran, S.; Sreedhar, Rupa

    2015-01-01

    We describe an incident of development of acute pulmonary edema after the device closure of a secundum atrial septal defect in a 52-year-old lady, which was treated with inotropes, diuretics and artificial ventilation. Possibility of acute left ventricular dysfunction should be considered after the defect closure in the middle-aged patients as the left ventricular compliance may be reduced due to increased elastic stiffness and diastolic dysfunction. Baseline left atrial pressure may be > 10 mmHg in these patients. Associated risk factors for the left ventricular dysfunction are a large Qp:Qs ratio, systemic hypertension, severe pulmonary hypertension and paroxysmal atrial fibrillation. PMID:26139760

  10. 40 CFR 265.280 - Closure and post-closure.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... contaminants caused by wind erosion; and (4) Compliance with § 265.276 concerning the growth of food-chain... unit as appropriate for its post-closure use; (3) Assure that growth of food chain crops complies with...

  11. 40 CFR 265.280 - Closure and post-closure.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... contaminants caused by wind erosion; and (4) Compliance with § 265.276 concerning the growth of food-chain... unit as appropriate for its post-closure use; (3) Assure that growth of food chain crops complies with...

  12. 40 CFR 265.280 - Closure and post-closure.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... contaminants caused by wind erosion; and (4) Compliance with § 265.276 concerning the growth of food-chain... unit as appropriate for its post-closure use; (3) Assure that growth of food chain crops complies with...

  13. 40 CFR 265.280 - Closure and post-closure.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... contaminants caused by wind erosion; and (4) Compliance with § 265.276 concerning the growth of food-chain... unit as appropriate for its post-closure use; (3) Assure that growth of food chain crops complies with...

  14. Closure report for N Reactor

    SciTech Connect

    Not Available

    1994-01-01

    This report has been prepared to satisfy Section 3156(b) of Public Law 101-189 (Reports in Connection with Permanent Closures of Department of Energy Defense Nuclear Facilities), which requires submittal of a Closure Report to Congress by the Secretary of Energy upon the permanent cessation of production operations at a US Department of Energy (DOE) defense nuclear facility (Watkins 1991). This closure report provides: (1) A complete survey of the environmental problems at the facility; (2) Budget quality data indicating the cost of environmental restoration and other remediation and cleanup efforts at the facility; (3) A proposed cleanup schedule.

  15. Determination of palpebral closure using a Hall sensor magnet pair.

    PubMed

    Hamiel, S R; Tubach, M R; Bleicher, J N; Cronan, J C

    1994-02-01

    A small device that can detect eyelid closure was designed using a Hall sensor and magnet. The ability of the sensor to differentiate blinks from saccadic motion is of vital interest in development of a device to alleviate complications of facial nerve paralysis. Twelve physically normal human subjects were used in this study. A small Hall sensor (3 x 2.5 x 1.1 mm), a device that detects magnetic fields, was attached to the lower eyelid near the lid margin, and an opposing small magnet (3 x 2 x 1 mm) was attached to the upper eyelid, also near the lid margin. Output potentials from the Hall sensor were monitored during eye blinks and saccadic eye movements to correlate sensor potentials with eye movements. Results indicate that the Hall sensor is effective at determining palpebral closure and discriminating eye closure from other eye movements. Therefore, we conclude that the Hall sensor is a reliable means for determining palpebral closure and is ideally suited for use in a facial prosthesis that uses the normal blink as a trigger to reanimate the contralateral paralyzed eyelid.

  16. A comparative study of different imaging modalities for successful percutaneous left atrial appendage closure

    PubMed Central

    Chow, Danny HF; Bieliauskas, Gintautas; Sawaya, Fadi J; Millan-Iturbe, Oscar; Kofoed, Klaus F; Søndergaard, Lars; De Backer, Ole

    2017-01-01

    Objectives Accurate sizing of the left atrial appendage (LAA) is essential when performing percutaneous LAA closure. This study aimed to compare different LAA imaging modalities and sizing methods in order to obtain successful LAA closure. Background Percutaneous LAA closure is an increasingly used treatment strategy to prevent stroke in patients with atrial fibrillation. LAA sizing has typically been done by 2D-transoesophageal echocardiography (TEE). Methods Patients who had a preprocedural TEE and preprocedural and postprocedural multislice CT (MSCT) were identified. Preprocedural measurements of LAA ostia and landing zones by 2D-TEE, MSCT and angiography were collected and analysed for those patients with successful LAA closure - i.e. with no contrast leakage at 3-month follow-up MSCT. Results The study population (n=67) had a mean CHA2DS2-VASc score of 3.0 and HAS-BLED score of 2.7. Fifty-eight patients (87%) were identified to have successful LAA closure. Based on MSCT, 48 LAA sizings (83%) resulted in a correct LAA closure device size selection, whereas with 2D-TEE sizing, only 33 measurements (57%) would have resulted in a correct device size selection (p<0.01). Using adapted Bland-Altman method, MSCT-based perimeter-derived mean diameter was shown to be the best parameter to guide LAA device size selection for ‘closed-end’ devices (Amulet, WatchmanFLX), whereas the maximal diameter was the best parameter for the ‘open-end’ Watchman device. Conclusions Preprocedural MSCT-based LAA closure device size selection proves to be a more accurate method than conventional 2D-TEE-based sizing. Depending on the LAA closure device design, perimeter-derived mean diameter or maximal diameter could be the better sizing method. PMID:28761682

  17. A comparative study of different imaging modalities for successful percutaneous left atrial appendage closure.

    PubMed

    Chow, Danny Hf; Bieliauskas, Gintautas; Sawaya, Fadi J; Millan-Iturbe, Oscar; Kofoed, Klaus F; Søndergaard, Lars; De Backer, Ole

    2017-01-01

    Accurate sizing of the left atrial appendage (LAA) is essential when performing percutaneous LAA closure. This study aimed to compare different LAA imaging modalities and sizing methods in order to obtain successful LAA closure. Percutaneous LAA closure is an increasingly used treatment strategy to prevent stroke in patients with atrial fibrillation. LAA sizing has typically been done by 2D-transoesophageal echocardiography (TEE). Patients who had a preprocedural TEE and preprocedural and postprocedural multislice CT (MSCT) were identified. Preprocedural measurements of LAA ostia and landing zones by 2D-TEE, MSCT and angiography were collected and analysed for those patients with successful LAA closure - i.e. with no contrast leakage at 3-month follow-up MSCT. The study population (n=67) had a mean CHA2DS2-VASc score of 3.0 and HAS-BLED score of 2.7. Fifty-eight patients (87%) were identified to have successful LAA closure. Based on MSCT, 48 LAA sizings (83%) resulted in a correct LAA closure device size selection, whereas with 2D-TEE sizing, only 33 measurements (57%) would have resulted in a correct device size selection (p<0.01). Using adapted Bland-Altman method, MSCT-based perimeter-derived mean diameter was shown to be the best parameter to guide LAA device size selection for ‘closed-end’ devices (Amulet, WatchmanFLX), whereas the maximal diameter was the best parameter for the ‘open-end’ Watchman device. Preprocedural MSCT-based LAA closure device size selection proves to be a more accurate method than conventional 2D-TEE-based sizing. Depending on the LAA closure device design, perimeter-derived mean diameter or maximal diameter could be the better sizing method.

  18. Patent foramen ovale closure with the Gore septal occluder: initial UK experience.

    PubMed

    Thomson, John D; Hildick-Smith, David; Clift, Paul; Morgan, Gareth; Daniels, Matthew; Henderson, Robert; Spence, Mark S; Mahadevan, Vaikom S; Crossland, David; Ormerod, Oliver

    2014-02-15

    To report procedural outcome and short-term follow-up data for the Gore septal occluder (GSO), a new device for closure of patent foramen ovale (PFO). Transcatheter closure of PFO is an established treatment modality but no current device provides a perfect solution. The GSO has a number of design features, which make it potentially attractive for closure of defects in the atrial septum. Data from 9 centers in the United Kingdom implanting the GSO device, submitted to an electronic registry for evaluation. Two hundred twenty-nine patients undergoing PFO closure from June 2011 to October 2012 were included. Indications for closure were secondary prevention of paradoxical cerebral emboli (83.4%), migraine (2.1%), platypnoea orthodeoxia (3.9%), and other (10.5%). Median PFO size was 8 mm and 34 and 39%, respectively, had long tunnel anatomy or atrial septal aneurysms. A GSO was successfully implanted in all cases. A single device was used in 98% but in 4 patients the initial device was removed and a second device required. Procedural complications occurred in 3% and later complications (e.g., atrial fibrillation, atrial ectopics, and device thrombus) in 5.7% of cases. All patients have undergone clinical and echocardiographic follow-up and all devices remain in position. Early bubble studies (median 0 months) with Valsalva maneuver in 67.2% were negative in 89%. The GSO is an effective occlusion device for closure of PFO of all types. Longer-term follow-up particularly to document later closure rates are required. Copyright © 2013 Wiley Periodicals, Inc.

  19. Pinhole closure measurements

    NASA Astrophysics Data System (ADS)

    Milam, David; Murray, James E.; Estabrook, Kent G.; Boley, Charles D.; Sell, Walter D.; Nielsen, Norman D.; Kirkwood, R. K.; Zakharenkov, Yuri A.; Afeyan, Bedros B.

    1999-07-01

    Spatial-filter pinholes and knife-edge samples were irradiated in vacuum by 1053-nm, 5-20 ns pulses at intensities to 500 GW/cm2. The knife-edge samples were fabricated of plastic, carbon, aluminum, stainless steel, molybdenum, tantalum, gold, and an absorbing glass. Time- resolved two-beam interferometry with a 40-ns probe pulse was used to observe phase shifts in the expanding laser- induced plasma. For al of these materials, at any time during square-pulse irradiation, the phase shift fell exponentially with distance from the edge of the sample.. The expansion was characterized by the propagation velocity V2(pi ) of the contour for a 2(pi) phase shift. To within experimental error, V2(pi ) was constant during irradiation at a particular intensity, and it increased linearly with intensity for intensities < 300 GW/cm2. For metal samples V2(pi ) exhibited an approximate M-0.5 dependence where M is the atomic mass. Plasmas of plastic, carbon, and absorbing glass produced larger phase shifts, and expanded more rapidly, than plasmas of heavy metals. The probe beam and interferometer were also used to observe the closing of pinholes. With planar pinholes, accumulation of on-axis plasma was observed along with the advance of plasma away from the edge of the hole. On-axis closure was not observed in square, 4-leaf pinholes.

  20. Echocardiographic guidance and monitoring of left atrial appendage closure with AtriClip during open-chest cardiac surgery.

    PubMed

    Contri, Rachele; Clivio, Sara; Torre, Tiziano; Cassina, Tiziano

    2017-09-12

    Left atrial appendage (LAA) closure prevents thromboembolic risk and avoids lifelong anticoagulation due to atrial fibrillation (AF). Nowadays, AtriClip, a modern epicardial device approved in June 2010, allows external and safe closure of LAA in patients undergoing cardiac surgery during other open-chest cardiac surgical procedures. Such a surgical approach and its epicardial deployment differentiates LAA closure with AtriClip from percutaneous closure techniques such as Watchman (Boston Scientific, Marlborough, MA, USA), Lariat (SentreHEART Inc., Redwood City, CA, USA), and Amplatzer Amulet (St. Jude Medical, St. Paul, MN, USA) device procedures. AtriClip positioning must consider perioperative transesophageal echocardiography (TEE) to confirm LAA anatomical features, to explore the links with neighboring structures, and finally to assess its successful closure. We report a sequence of images to document the role of intraoperative TEE during an elective aortic valve replacement and LAA external closure with AtriClip. © 2017, Wiley Periodicals, Inc.

  1. Closure and Sealing Design Calculation

    SciTech Connect

    T. Lahnalampi; J. Case

    2005-08-26

    The purpose of the ''Closure and Sealing Design Calculation'' is to illustrate closure and sealing methods for sealing shafts, ramps, and identify boreholes that require sealing in order to limit the potential of water infiltration. In addition, this calculation will provide a description of the magma that can reduce the consequences of an igneous event intersecting the repository. This calculation will also include a listing of the project requirements related to closure and sealing. The scope of this calculation is to: summarize applicable project requirements and codes relating to backfilling nonemplacement openings, removal of uncommitted materials from the subsurface, installation of drip shields, and erecting monuments; compile an inventory of boreholes that are found in the area of the subsurface repository; describe the magma bulkhead feature and location; and include figures for the proposed shaft and ramp seals. The objective of this calculation is to: categorize the boreholes for sealing by depth and proximity to the subsurface repository; develop drawing figures which show the location and geometry for the magma bulkhead; include the shaft seal figures and a proposed construction sequence; and include the ramp seal figure and a proposed construction sequence. The intent of this closure and sealing calculation is to support the License Application by providing a description of the closure and sealing methods for the Safety Analysis Report. The closure and sealing calculation will also provide input for Post Closure Activities by describing the location of the magma bulkhead. This calculation is limited to describing the final configuration of the sealing and backfill systems for the underground area. The methods and procedures used to place the backfill and remove uncommitted materials (such as concrete) from the repository and detailed design of the magma bulkhead will be the subject of separate analyses or calculations. Post-closure monitoring will not

  2. Surgical management of complications caused by transcatheter ASD closure.

    PubMed

    Mellert, F; Preusse, C J; Haushofer, M; Winkler, K; Nill, C; Pfeiffer, D; Redel, D; Lüderitz, B; Welz, A

    2001-12-01

    Transcatheter occlusion of uncomplicated atrial septum defects (ASD) is recognized as an effective and minimally invasive method. Sometimes, serious early and late complications require surgical intervention. We therefore investigated reasons and outcomes of the secondary surgical approach. 5 patients (aged 5-73 yrs) were admitted to our institution for device explantation and surgical ASD closure. ASDOS devices (A devices) had to be explanted in 4 patients and a SIDERIS "buttoned" occluder (S device) had to be explanted in 1 patient. The period from transcatheter implantation to surgical explantation ranged from 1 hour to 3 years. 3 patients (60 %) had to be operated in an emergency setting. In our youngest patient (5 yrs), the A device separated and embolized into the aorta and pulmonary artery. A pregnant women who needed emergent cesarean section developed hemopericard and tamponade due to atrial perforation by a fractured leg of an A device. In another A device, a suspect endocarditis caused membrane perforation. Malpositioning of an S device was the reason for operation. All patients recovered well without neurological symptoms. Transcatheter closure of uncomplicated ASD is a feasible alternative but surgical stand-by is essential. Nevertheless more complicated ASD should be operated, especially since the cosmetically satisfactory techniques of minimal invasive heart surgery are available.

  3. RCRA closure of mixed waste impoundments

    SciTech Connect

    Blaha, F.J.; Greengard, T.C.; Arndt, M.B.

    1989-11-01

    A case study of a RCRA closure action at the Rocky Flats Plant is presented. Closure of the solar evaporation ponds involves removal and immobilization of a mixed hazardous/radioactive sludge, treatment of impounded water, groundwater monitoring, plume delineation, and collection and treatment of contaminated groundwater. The site closure is described within the context of regulatory negotiations, project schedules, risk assessment, clean versus dirty closure, cleanup levels, and approval of closure plans and reports. Lessons learned at Rocky Flats are summarized.

  4. The archaeology of uncommon interventions: Articulating the rationale for transcatheter closure of congenital coronary artery fistulas in asymptomatic children.

    PubMed

    McElhinney, Doff B

    2016-02-15

    Transcatheter closure of coronary artery fistulas can be executed successfully in infants and children with few serious procedural complications. Indications for and long-term outcomes of closure of coronary artery fistulas remain poorly defined. Registries may offer the best opportunity for advancing our knowledge about uncommon interventions such as coil or device closure of coronary artery fistulas, but to do so, they must include sufficient data and evaluate factors potentially associated with salutary or adverse outcome.

  5. Transcatheter patent foramen ovale closure in spite of interatrial septum hypertrophy or lipomatosis: a case series.

    PubMed

    Rigatelli, Gianluca; Dell'Avvocata, Fabio; Giordan, Massimo; Ronco, Federico; Braggion, Gabriele; Schenal, Nella; Aggio, Silvio; Cardaioli, Paolo

    2010-02-01

    Hypertrophy and lipomatosis of the interatrial septum have been thought to be contraindications for transcatheter patent foramen ovale (PFO) and atrial septal defect closure because of the limits of current devices and the risk of suboptimal results. No reports have been produced yet about PFO closure in patients with such conditions. We retrospectively assessed the safety and effectiveness of PFO closure in patients with hypertrophy or lipomatosis of fossa ovalis rims. We searched our database of 140 consecutive patients (mean age 43 +/- 15. 5 years, 98 female patients) who underwent transcatheter PFO closure for cases of hypertrophy or lipomatosis of the interatrial septum. All patients were screened with transesophageal echocardiography before the operation. All patients underwent intracardiac echocardiography study and attempted closure. Ten patients (7.1%) underwent an attempt at transcatheter closure in the presence of hypertrophy of the rims (eight patients) or lipomatosis (two patients). All patients were aged more than 50 years and has multiple recurrent stroke events (nine patients) or need for a posterior cerebral surgical procedure (one patient) making closure mandatory. After intracardiac echocardiography study and measurements, two 25 mm Amplatzer and eight 25 mm Premere Occlusion System devices have been implanted successfully. On mean follow-up of 36.6 +/- 14.8 months, two patients had a small residual shunt: no recurrence of stroke or aortic erosion or device thrombosis was observed during this period. Transcatheter PFO closure in the presence of hypertrophy or lipomatosis of fossa ovalis rims is not contraindicated per se: careful evaluation of rim thickness with intracardiac echocardiography and selection of soft and asymmetrically opening devices may allow for a safe and effective PFO closure, at least in patients with no severe atrial septal aneurysm.

  6. Safety of percutaneous patent ductus arteriosus closure: an unselected multicenter population experience.

    PubMed

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

    2013-11-27

    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. 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). 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.

  7. Linearly exact parallel closures for slab geometry

    NASA Astrophysics Data System (ADS)

    Ji, Jeong-Young; Held, Eric D.; Jhang, Hogun

    2013-08-01

    Parallel closures are obtained by solving a linearized kinetic equation with a model collision operator using the Fourier transform method. The closures expressed in wave number space are exact for time-dependent linear problems to within the limits of the model collision operator. In the adiabatic, collisionless limit, an inverse Fourier transform is performed to obtain integral (nonlocal) parallel closures in real space; parallel heat flow and viscosity closures for density, temperature, and flow velocity equations replace Braginskii's parallel closure relations, and parallel flow velocity and heat flow closures for density and temperature equations replace Spitzer's parallel transport relations. It is verified that the closures reproduce the exact linear response function of Hammett and Perkins [Phys. Rev. Lett. 64, 3019 (1990)] for Landau damping given a temperature gradient. In contrast to their approximate closures where the vanishing viscosity coefficient numerically gives an exact response, our closures relate the heat flow and nonvanishing viscosity to temperature and flow velocity (gradients).

  8. Towards a mesoscale eddy closure

    NASA Astrophysics Data System (ADS)

    Eden, Carsten; Greatbatch, Richard J.

    A turbulence closure for the effect of mesoscale eddies in non-eddy-resolving ocean models is proposed. The closure consists of a prognostic equation for the eddy kinetic energy (EKE) that is integrated as an additional model equation, and a diagnostic relation for an eddy length scale ( L), which is given by the minimum of Rhines scale and Rossby radius. Combining EKE and L using a standard mixing length assumption gives a diffusivity ( K), corresponding to the thickness diffusivity in the [Gent, P.R., McWilliams, J.C. 1990. Isopycnal mixing in ocean circulation models. J. Phys. Oceanogr. 20, 150-155] parameterisation. Assuming downgradient mixing of potential vorticity with identical diffusivity shows how K is related to horizontal and vertical mixing processes in the horizontal momentum equation, and also enables us to parameterise the source of EKE related to eddy momentum fluxes. The mesoscale eddy closure is evaluated using synthetic data from two different eddy-resolving models covering the North Atlantic Ocean and the Southern Ocean, respectively. The diagnosis shows that the mixing length assumption together with the definition of eddy length scales is valid within certain limitations. Furthermore, implementation of the closure in non-eddy-resolving models of the North Atlantic and the Southern Ocean shows consistently that the closure has skill at reproducing the results of the eddy-resolving model versions in terms of EKE and K.

  9. Fast-Tracking Colostomy Closures.

    PubMed

    Nanavati, Aditya J; Prabhakar, Subramaniam

    2015-12-01

    There have been very few studies on applying fast-track principles to colostomy closures. We believe that outcome may be significantly improved with multimodal interventions in the peri-operative care of patients undergoing this procedure. A retrospective study was carried out comparing patients who had undergone colostomy closures by the fast-track and traditional care protocols at our centre. We intended to analyse peri-operative period and recovery in colostomy closures to confirm that fast-track surgery principles improved outcomes. Twenty-six patients in the fast-track arm and 24 patients in the traditional care arm had undergone colostomy closures. Both groups were comparable in terms of their baseline parameters. Patients in the fast-track group were ambulatory and accepted oral feeding earlier. There was a significant reduction in the duration of stay (4.73 ± 1.43 days vs. 7.21 ± 1.38 days, p = 0.0000). We did not observe a rise in complications or 30-day re-admissions. Fast-track surgery can safely be applied to colostomy closures. It shows earlier ambulation and reduction in length of hospital stay.

  10. Cabled butterfly closure: a novel technique for sternal closure.

    PubMed

    Jolly, Shashank; Flom, Beau; Dyke, Cornelius

    2012-10-01

    Impaired sternal wound healing remains problematic after median sternotomy and can lead to significant morbidity after cardiac surgical procedures. Although metal plating systems exist for closing the sternum, their use is limited by expense and practicality, and simple wire closure remains the most common technique to close the sternum. We describe a cabling technique for sternal closure that is secure, uses standard sternal wire, and may be used on every patient. We have used the technique routinely in 291 patients with no sternal dehiscence or wound healing problems.

  11. Stress-relaxation and tension relief system for immediate primary closure of large and huge soft tissue defects: an old-new concept: new concept for direct closure of large defects.

    PubMed

    Topaz, Moris; Carmel, Narin Nard; Topaz, Guy; Li, Mingsen; Li, Yong Zhong

    2014-12-01

    Stress-relaxation is a well-established mechanism for laboratory skin stretching, with limited clinical application in conventional suturing techniques due to the inherent, concomitant induction of ischemia, necrosis and subsequent suture failure. Skin defects that cannot be primarily closed are a common difficulty during reconstructive surgery. The TopClosure tension-relief system (TRS) is a novel device for wound closure closure, providing secured attachment to the skin through a wide area of attachment, in an adjustable manner, enabling primary closure of medium to large skin defects. The aim of this study was to evaluate the efficiency of the TopClosure TRS as a substitute for skin grafting and flaps for primary closure of large soft tissue defects by stress-relaxation. We present three demonstrative cases requiring resection of large to huge tumors customarily requiring closure by skin graft or flaps. TRS was applied during surgery serving as a tension-relief platform for tension sutures, to enable primary skin-defect closure by cycling of stress-relaxation, and following surgery as skin-secure system until complete wound closure. All skin defects ranging from 7 to 26 cm in width were manipulated by the TRS through stress-relaxation, without undermining of skin, enabling primary skin closure and eliminating the need for skin grafts and flaps. Immediate wound closure ranged 26 to 135 min. TRS was applied for 3 to 4 weeks. Complications were minimal and donor site morbidity was eliminated. Surgical time, hospital stay and costs were reduced and wound aesthetics were improved. In this case series we present a novel technology that enables the utilization of the viscoelastic properties of the skin to an extreme level, extending the limits of primary wound closure by the stress-relaxation principle. This is achieved via a simple device application that may aid immediate primary wound closure and downgrade the complexity of surgical procedures for a wide range

  12. Closure of Building 624 incinerator

    SciTech Connect

    Ridley, M.N.; Hallisey, M.L.; Terusaki, S.; Steverson, M.

    1992-06-01

    The Building 624 incinerator was a Resource Conservation Recovery Act (RCRA) mixed waste incinerator at Lawrence Livermore National Laboratory (LLNL). This incinerator was in operation from 1978 to 1989. The incinerator was to be closed as a mixed waste incinerator, but was to continue burning classified nonhazardous solid waste. The decision was later made to discontinue all use of the incinerator. Closure activities were performed from June 15 to December 15, 1991, when a clean closure was completed. The main part of the closure was the characterization, which included 393 samples and 30 blanks. From these 393 samples, approximately 13 samples indicated the need for further investigation, such as an isotopic scan; however, none of the samples was concluded to be hazardous or radioactive.

  13. Sampling and monitoring for closure

    USGS Publications Warehouse

    McLemore, Virginia T.; Smith, Kathleen S.; Russell, Carol C.

    2007-01-01

    An important aspect of planning a new mine or mine expansion within the modern regulatory framework is to design for ultimate closure. Sampling and monitoring for closure is a form of environmental risk management. By implementing a sampling and monitoring program early in the life of the mining operation, major costs can be avoided or minimized. The costs for treating mine drainage in perpetuity are staggering, especially if they are unanticipated. The Metal Mining Sector of the Acid Drainage Technology Initiative (ADTI-MMS), a cooperative government-industry-academia organization, was established to address drainage-quality technologies of metal mining and metallurgical operations. ADTI-MMS recommends that sampling and monitoring programs consider the entire mine-life cycle and that data needed for closure of an operation be collected from exploration through postclosure.

  14. Fundamental base closure environmental principles

    SciTech Connect

    Yim, R.A.

    1994-12-31

    Military base closures present a paradox. The rate, scale and timing of military base closures is historically unique. However, each base itself typically does not present unique problems. Thus, the challenge is to design innovative solutions to base redevelopment and remediation issues, while simultaneously adopting common, streamlined or pre-approved strategies to shared problems. The author presents six environmental principles that are fundamental to base closure. They are: remediation not clean up; remediation will impact reuse; reuse will impact remediation; remediation and reuse must be coordinated; environmental contamination must be evaluated as any other initial physical constraint on development, not as an overlay after plans are created; and remediation will impact development, financing and marketability.

  15. [Endoscopic vacuum-assisted closure].

    PubMed

    Wedemeyer, J; Lankisch, T

    2013-03-01

    Anastomotic leakage in the upper and lower intestinal tract is associated with high morbidity and mortality. Within the last 10 years endoscopic treatment options have been accepted as sufficient treatment option of these surgical complications. Endoscopic vacuum assisted closure (E-VAC) is a new innovative endoscopic therapeutic option in this field. E-VAC transfers the positive effects of vacuum assisted closure (VAC) on infected cutaneous wounds to infected cavities that can only be reached endoscopically. A sponge connected to a drainage tube is endoscopically placed in the leakage and a continuous vacuum is applied. Sponge and vacuum allow removal of infected fluids and promote granulation of the leakage. This results in clean wound grounds and finally allows wound closure. Meanwhile the method was also successfully used in the treatment of necrotic pancreatitis.

  16. Management of Secondary Angle Closure Glaucoma.

    PubMed

    Parivadhini, Annadurai; Lingam, Vijaya

    2014-01-01

    Secondary angle closure glaucomas are a distinct entity from primary angle closure glaucoma (PACG). Unlike PACG, secondary angle closure glaucoma's have an identifable contributory factor/s for angle closure and obstruction of aqueous fow which is usually unrelieved by iridotomy. The treatment of each type of secondary angle closure glaucoma is varied, so identification of the primary cause aids in its effective management. How to cite this article: Annadurai P, Vijaya L. Management of Secondary Angle Closure Glaucoma. J Current Glau Prac 2014;8(1):25-32.

  17. Automated Fuel Element Closure Welding System

    SciTech Connect

    Wahlquist, D.R.

    1993-03-01

    The Automated Fuel Element Closure Welding System is a robotic device that will load and weld top end plugs onto nuclear fuel elements in a highly radioactive and inert gas environment. The system was developed at Argonne National Laboratory-West as part of the Fuel Cycle Demonstration. The welding system performs four main functions, it (1) injects a small amount of a xenon/krypton gas mixture into specific fuel elements, and (2) loads tiny end plugs into the tops of fuel element jackets, and (3) welds the end plugs to the element jackets, and (4) performs a dimensional inspection of the pre- and post-welded fuel elements. The system components are modular to facilitate remote replacement of failed parts. The entire system can be operated remotely in manual, semi-automatic, or fully automatic modes using a computer control system. The welding system is currently undergoing software testing and functional checkout.

  18. Automated Fuel Element Closure Welding System

    SciTech Connect

    Wahlquist, D.R.

    1993-01-01

    The Automated Fuel Element Closure Welding System is a robotic device that will load and weld top end plugs onto nuclear fuel elements in a highly radioactive and inert gas environment. The system was developed at Argonne National Laboratory-West as part of the Fuel Cycle Demonstration. The welding system performs four main functions, it (1) injects a small amount of a xenon/krypton gas mixture into specific fuel elements, and (2) loads tiny end plugs into the tops of fuel element jackets, and (3) welds the end plugs to the element jackets, and (4) performs a dimensional inspection of the pre- and post-welded fuel elements. The system components are modular to facilitate remote replacement of failed parts. The entire system can be operated remotely in manual, semi-automatic, or fully automatic modes using a computer control system. The welding system is currently undergoing software testing and functional checkout.

  19. Entrapment of the StarClose Vascular Closure System After Attempted Common Femoral Artery Deployment

    SciTech Connect

    Durack, Jeremy C. Thor Johnson, D.; Fidelman, Nicholas; Kerlan, Robert K.; LaBerge, Jeanne M.

    2012-08-15

    A complication of the StarClose Vascular Closure System (Abbott, Des Plaines, IL) after a transarterial hepatic chemoembolization is described. After attempted clip deployment, the entire device became lodged in the tissues overlying the common femoral artery and could not be removed percutaneously. Successful removal of the device required surgical cutdown for removal and arterial repair. Entrapment of the StarClose vascular closure deployment system is a potentially serious complication that has been reported in the Manufacturer and User Facility Device Experience database, but has not been recognized in the literature.

  20. Closure phase and lucky imaging.

    PubMed

    Rhodes, William T

    2009-01-01

    Since its introduction by Jennison in 1958, the closure-phase method for removing the effects of electrical path-length errors in radio astronomy and of atmospheric turbulence in optical astronomy has been based on the non-redundant-spacing triple interferometer. It is shown that through application of lucky imaging concepts it is possible to relax this condition, making closure-phase methods possible with redundantly spaced interferometer configurations and thereby widening their range of application. In particular, a quadruple-interferometer can, under lucky imaging conditions, be treated as though it were a triple interferometer. The slit-annulus aperture is investigated as a special case.

  1. Alarm sensor apparatus for closures

    DOEpatents

    Carlson, J.A.; Stoddard, L.M.

    1984-01-31

    An alarm sensor apparatus for closures such as doors and windows, and particularly for closures having loose tolerances such as overhead doors, garage doors or the like, the sensor apparatus comprising a pair of cooperating bracket members, one being attached to the door facing or framework and the other to the door member, two magnetic sensor elements carried by said bracket members, the bracket members comprising a pair of cooperating orthogonal guide slots and plates and a stop member engageable with one of the sensors for aligning the sensors with respect to each other in all three orthogonal planes when the door is closed.

  2. Alarm sensor apparatus for closures

    DOEpatents

    Carlson, James A.; Stoddard, Lawrence M.

    1986-01-01

    An alarm sensor apparatus for closures such as doors and windows, and particularly for closures having loose tolerances such as overhead doors, garage doors or the like, the sensor apparatus comprising a pair of cooperating bracket members, one being attached to the door facing or frame work and the other to the door member, two magnetic sensor elements carried by said bracket members, the bracket members comprising a pair of cooperating orthogonal guide slots and plates and a stop member engageable with one of the sensors for aligning the sensors with respect to each other in all three orthogonal planes when the door is closed.

  3. Percutaneous closure of an aorta to left atrium fistula with an Amplatzer duct occluder.

    PubMed

    Feldman, Ted; Salinger, Michael H; Das, Sundeep; Hamilton, Andrew J

    2006-01-01

    We describe percutaneous closure of an unusual paravalvular leak, with a communication from the noncoronary cusp of the aortic valve to the left atrium adjacent to a St. Jude mitral valve prosthesis, in the absence of an infection. The patient presented with worsening dyspnea and edema. The anatomic location of the valve annulus adjacent to the noncoronary cusp underlies the etiology of this communication. Outcomes from surgical repair are associated with high mortality. We performed percutaneous closure of the defect, using general anesthesia and transesophageal echo guidance. An Amplatzer duct occluder was placed in the fistula, with immediate and complete closure of the shunt. While no devices specific for closure of paravalvular leaks have been designed, growing experience with a variety of devices and the use of echo guidance have allowed successful therapy in many complex cases.

  4. Apparatus and method for pressure testing closure disks

    DOEpatents

    Merten, C.W. Jr.

    1992-01-21

    A method and device are 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 tensile load is transmitted by a piston in combination with fluid pressure to the hollow notched plug. 5 figs.

  5. Apparatus and method for pressure testing closure disks

    DOEpatents

    Merten, Jr., Charles W.

    1992-01-21

    A method and 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 tensile load is transmitted by a piston in combination with fluid pressure to the hollow notched plug.

  6. 40 CFR 265.113 - Closure; time allowed for closure.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... section, at a hazardous waste management unit or facility, or within 90 days after approval of the closure...) The hazardous waste management unit or facility has the capacity to receive additional hazardous... another person will recommence operation of the hazardous waste management unit or the facility within...

  7. 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

  8. Percutaneous left atrial appendage closure: current state of the art.

    PubMed

    Jazayeri, Mohammad-Ali; Vuddanda, Venkat; Parikh, Valay; Lakkireddy, Dhanunjaya R

    2017-01-01

    The authors reviewed the seminal and more recent literature surrounding the major modalities for percutaneous left atrial appendage closure used in contemporary practice, with particular emphasis on safety and efficacy, technical challenges, and future developments. Along with the continued practice of surgical left atrial appendage closure, which has evolved substantially with the advent of clipping techniques, a number of percutaneous methods have been developed to close the left atrial appendage with endocardial, epicardial, and hybrid approaches. The last 18 months has seen the Food and Drug Administration approval of the WATCHMAN device for stroke prevention in the United States, the initiation of a randomized controlled trial to further examine the LARIAT device, and an increasing body of literature surrounding use of the AMPLATZER Amulet in Europe. Left atrial appendage closure is a promising alternative to systemic anticoagulation for stroke prevention in appropriate atrial fibrillation patients. The wealth of available data for the various modalities sheds light on the strengths and limitations of each, postprocedural complications and their management, and new areas for exploration. With a plethora of new devices on the horizon, it is a very exciting time in the field of 'appendage-ology' as we pursue new avenues to optimize care for atrial fibrillation patients.

  9. 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...

  10. Endobronchial closure of bronchopleural fistulas with Amplatzer vascular plug

    PubMed Central

    Fruchter, Oren; Bruckheimer, Elchanan; Raviv, Yael; Rosengarten, Dror; Saute, Milton; Kramer, Mordechai R.

    2012-01-01

    OBJECTIVE Bronchopulmonary fistula (BPF) is a severe complication following lobectomy or pneumonectomy and is associated with a high rate of morbidity and mortality. We have developed a novel minimally invasive method of central BPF closure using Amplatzer vascular plug (AVP) device that was originally designed for the transcatheter closure of vascular structures in patients with small BPF. METHODS Patients with BPFs were treated under conscious sedation by bronchoscopic closure of BPFs using AVP. After locating the fistula using bronchography, the self-expanding nitinol made AVP occluder to be delivered under direct bronchoscopic guidance over a loader wire into the fistula followed by bronchography to assure correct device positioning and sealing of the BPF. RESULTS Six AVPs were placed in five patients, four males and one female, with a mean age of 62.3 years (range: 51–82 years). The underlying disorders and etiologies for BPF development were lobectomy (two patients), pneumonectomy for lung cancer (one patient), lobectomy due to necrotizing pneumonia (one patient), and post-tracheostomy tracheo-pleural fistula (one patient). In all the patients, the bronchoscopic procedure was successful and symptoms related to BPF disappeared following closure by the AVP. The results were maintained over a median follow-up of 9 months (range: 5–34 months). CONCLUSIONS Endobronchial closure using the AVP is a safe and effective method for treatment of small postoperative BPF. The ease of their implantation by bronchoscopy under conscious sedation adds this novel technique to the armatorium of minimally invasive modalities for the treatment of small BPF. PMID:21600781

  11. DNAPL Remediation: Selected Projects Approaching Regulatory Closure

    EPA Pesticide Factsheets

    This paper is a status update on the use of DNAPL source reduction remedial technologies, and provides information about recent projects where regulatory closure has been reached or projects are approaching regulatory closure, following source reduction.

  12. Novel use of the medtronic micro vascular plug for PDA closure in preterm infants.

    PubMed

    Wang-Giuffre, Elizabeth W; Breinholt, John P

    2017-05-01

    To describe a single institution experience with a new endovascular occlusion device used for transcatheter patent ductus arteriosus (PDA) closure in preterm infants. The PDA is a defect largely treated via cardiac catheterization except for the smallest patients. Medical records and catheterization reports of all premature neonates who underwent PDA device closure with the Medtronic Micro Vascular Plug (MVP) (Medtronic, Minneapolis, MN) between September 2015 and June 2016 were reviewed. Procedural details, complications, and short term outcomes were recorded. Eight premature neonates born at a median gestational age of 28 weeks (23 to 35 weeks) underwent PDA closure with a Medtronic MVP. All devices were deployed via a 4F angled Glide catheter in prograde fashion without arterial access. Median age and weight was 52 days (15-112 days) and 2,550 g (1,800-3,500 g), respectively. Fluoroscopy and echocardiography were utilized for the procedure. Complete closure was achieved in all patients with no procedural complications, pulmonary artery or aortic obstruction or death. One device embolized 9 days after deployment and was successfully retrieved. This study describes transcatheter PDA closure with the Medtronic MVP. The major advantage is the ability to deliver the device via a standard catheter in prograde fashion, and avoid the hemodynamic instability produced by rigid delivery sheaths. It also further validates the ability to close the PDA without arterial access, providing improved access to this procedure to smaller and more vulnerable children. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  13. Equilateral triangular ferroelectric closure domains in (111)-oriented epitaxial Pb(Zr,Ti)O3 thin films

    NASA Astrophysics Data System (ADS)

    Yang, Sang Mo; Shin, Y. J.; Noh, T. W.; Ehara, Y.; Funakubo, H.; Yoon, J.-G.; Scott, J. F.

    2013-03-01

    Over 60 years ago, Charles Kittel predicted that intriguing quadrant flux-closure domains could spontaneously form in small ferromagnetic platelets. Such quadrant flux-closure domains are considered as a precursor for the true vortex states, having attracted particular interest for storing memory devices. Although the vortex states are now ubiquitous and rather well understood in ferromagnets, even the flux-closure domains as their precursors are much less established in ferroelectrics (FEs). Here we report the generation of novel equilateral triangular FE closure domains. We generated such intriguing states by using the high crystalline anisotropy energy of a (111)-oriented epitaxial PbZr0.35Ti0.65O3 thin film. Vector piezoresponse force microscopy analysis showed clearly the equilateral triangular closure states, consisting of three stripe domain bundles with three 120 degree orientation differences. Interestingly, the observed two closure states had the different rotation direction around the core, i.e., clockwise and anti-clockwise.

  14. Endoluminal methods for gastrotomy closure in natural orifice transenteric surgery (NOTES).

    PubMed

    Sclabas, Guido M; Swain, Paul; Swanstrom, Lee L

    2006-03-01

    Natural orifice transenteric surgery (NOTES) is a new and rapidly evolving concept for intra-abdominal operations that offers the potential for a revolutionary advance in patient care. Conceptually, operations that currently require an open or laparoscopic approach could be performed without incisions in the abdomen, with their concomitant pain and scarring. A recent consensus statement by a joint group of gastrointestinal surgeons and gastroenterologists has identified several technical and technologic hurdles that would need to be overcome before NOTES becomes a clinical reality. One of the most significant requirements identified is the need for a very secure closure of the gastrotomy site that is required for scope passage and specimen removal. Although a rapidly expanding variety of transgastric procedures has been reported, only a few reports address the basic problem of gastrotomy closure. Availability of a safe and simple gastrotomy closure device, however, will be essential for the widespread adoption of the new field of NOTES. Unless new safe and simple devices for endoscopic gastrotomy closure are available and have proven efficacy, NOTES will remain in the hands of a few specialists at centers of excellence because the risk of complications due to insufficient gastrotomy closure will not be acceptable for the surgeon and gastroenterologist in general practice. In this article, we describe three new devices in development or newly on the market that are targeted to advance the safe endoscopic closure of gastrotomy from NOTES.

  15. Long-term outcome of percutaneous closure of secundum-type atrial septal defects in adults.

    PubMed

    Luermans, Justin G L M; Post, Martijn C; ten Berg, Jurriën M; Plokker, H W Thijs; Suttorp, Maarten J

    2010-11-01

    Transcatheter closure of the secundum-type atrial septal defect (ASD) is widely practised. We report complications and efficacy of percutaneous ASD closure in adults using the Amplatzer ASD occluder and the Cardioseal/Starflex device during long-term follow-up. Between 1996 and 2008 percutaneous ASD closure was performed in 133 patients (mean age 46.8 ± 16.9 years; 36 men) by using the Amplatzer(r) device in 104 patients and the Cardioseal/Starflex device in 29. During a mean follow-up of 3.4 ± 2.8 years the occurrence of major complications was higher in patients with the Cardioseal/Starflex compared to patients with the Amplatzer(r) devices (17.2 vs. 2.9%, log rank, P=0.005), due to a higher embolisation rate (13.8 vs. 1.0%, log rank, P=0.002). In univariable analysis, the implantation of a Cardioseal/Starflex device (OR 6.0 (CI 1.4-25.2); P=0.01) and a larger device diameter (OR 1.1 (CI 1.0-1.2); P=0.04) were found to be predictors of the occurrence of major complications. Minor complications occurred in 10.5%, recurrent thrombo-embolism in 2.3% and residual shunting at six months was 13.9% without differences between devices. NYHA class improved from 1.8 ± 0.6 before to 1.2 ± 0.4 after closure (P<0.001) without differences between devices. During long-term follow-up, percutaneous ASD closure in adults is safe and effective when using the Amplatzer(r) device. Larger Cardioseal/Starflex devices are related to a higher embolisation rate. Randomised trials are needed.

  16. 40 CFR 146.71 - Closure.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Waste Injection Wells § 146.71 Closure. (a) Closure Plan. The owner or operator of a Class I hazardous waste injection well shall prepare, maintain, and comply with a plan for closure of the well that meets... injection well who ceases injection temporarily, may keep the well open provided he: (i) Has received...

  17. 40 CFR 146.71 - Closure.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Waste Injection Wells § 146.71 Closure. (a) Closure Plan. The owner or operator of a Class I hazardous waste injection well shall prepare, maintain, and comply with a plan for closure of the well that meets... injection well who ceases injection temporarily, may keep the well open provided he: (i) Has received...

  18. 40 CFR 146.71 - Closure.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Waste Injection Wells § 146.71 Closure. (a) Closure Plan. The owner or operator of a Class I hazardous waste injection well shall prepare, maintain, and comply with a plan for closure of the well that meets... injection well who ceases injection temporarily, may keep the well open provided he: (i) Has received...

  19. 40 CFR 146.71 - Closure.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Waste Injection Wells § 146.71 Closure. (a) Closure Plan. The owner or operator of a Class I hazardous waste injection well shall prepare, maintain, and comply with a plan for closure of the well that meets... injection well who ceases injection temporarily, may keep the well open provided he: (i) Has received...

  20. 40 CFR 146.71 - Closure.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Waste Injection Wells § 146.71 Closure. (a) Closure Plan. The owner or operator of a Class I hazardous waste injection well shall prepare, maintain, and comply with a plan for closure of the well that meets... injection well who ceases injection temporarily, may keep the well open provided he: (i) Has received...

  1. Weighted Case Closure and Counselor Performance

    ERIC Educational Resources Information Center

    Worrall, John D.

    1978-01-01

    Use of the 26 closure may lead to serious problems in the evaluation of counselor performance. This article examines some of the shortcomings, briefly reviews several suggestions for weighting case closure, and introduces two possible weighting methods for case closure. (Author)

  2. Multidisciplinary Assessment in Optimising Results of Percutaneous Patent Foramen Ovale Closure.

    PubMed

    Davies, Allan; Ekmejian, Avedis; Collins, Nicholas; Bhagwandeen, Rohan

    2017-03-01

    Percutaneous patent foramen ovale (PFO) closure is a therapeutic option to prevent recurrent cerebral ischaemia in patients with cryptogenic stroke and transient cerebral ischaemia (TIA). The apparent lack of benefit seen in previous randomised trials has, in part, reflected inclusion of patients with alternate mechanisms of stroke. The role of formal neurology involvement in accurately delineating the likely aetiology of stroke or TIA is crucial in appropriate identification of patients for device closure. Furthermore, as the benefits of device closure may accrue over time, long-term follow-up is essential to define the role of device closure in management of presumed cryptogenic stroke. We retrospectively reviewed our experience with percutaneous PFO device closure since 2005. All subjects who underwent PFO closure at John Hunter and Lake Macquarie Private Hospitals were included in the study. All patients referred for device closure following cryptogenic stroke or TIA had first undergone formal neurology review with appropriate imaging and exclusion of paroxysmal atrial arrhythmia. Patients with a history of transient ischaemic attack (TIA) are frequently referred to a specialised clinic, aimed to identify patients with conditions not referable to cerebral ischaemia, with investigations initiated by the specialist clinic to elucidate an underlying aetiology. Outcome data was derived from the Hunter New England Area Local Health District Cardiac and Stroke Outcomes Unit, in addition to review of the medical record. The Cardiac and Stroke Outcomes Unit prospectively identified all patients presenting with stroke, TIA and atrial fibrillation. One hundred and twelve consecutive patients undergoing percutaneous patent foramen ovale closure between 2005 and 2015 were identified. The average age was 42.7 years and 57 (50.9%) patients were male. Cryptogenic stroke (68.8%) and transient cerebral ischaemia (23.2%) were the most common indications for PFO closure, with the

  3. 40 CFR 258.61 - Post-closure care requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Post-closure care requirements. 258.61... FOR MUNICIPAL SOLID WASTE LANDFILLS Closure and Post-Closure Care § 258.61 Post-closure care requirements. (a) Following closure of each MSWLF unit, the owner or operator must conduct post-closure...

  4. 40 CFR 265.112 - Closure plan; amendment of plan.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 27 2012-07-01 2012-07-01 false Closure plan; amendment of plan. 265... DISPOSAL FACILITIES Closure and Post-Closure § 265.112 Closure plan; amendment of plan. (a) Written plan... have a written closure plan. Until final closure is completed and certified in accordance with §...

  5. 40 CFR 265.112 - Closure plan; amendment of plan.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 26 2014-07-01 2014-07-01 false Closure plan; amendment of plan. 265... DISPOSAL FACILITIES Closure and Post-Closure § 265.112 Closure plan; amendment of plan. (a) Written plan... have a written closure plan. Until final closure is completed and certified in accordance with §...

  6. Generalized Convective Quasi-Equilibrium Closure

    NASA Astrophysics Data System (ADS)

    Yano, Jun-Ichi; Plant, Robert

    2016-04-01

    Arakawa and Schubert proposed convective quasi-equilibrium as a basic principle for closing their spectrum mass-flux convection parameterization. In deriving this principle, they show that the cloud work function is a key variable that controls the growth of convection. Thus, this closure hypothesis imposes a steadiness of the cloud work function tendency. This presentation shows how this principle can be generalized so that it can also encompasses both the CAPE and the moisture-convergence closures. Note that the majority of the current mass-flux convection parameterization invokes a CAPE closure, whereas the moisture-convergence closure was extremely popular historically. This generalization, in turn, includes both closures as special cases of convective quasi-equilibrium. This generalization further suggests wide range of alternative possibilities for convective closure. In general, a vertical integral of any function depending on both large-scale and convective-scale variables can be adopted as an alternative closure variables, leading to an analogous formulation as Arakawa and Schubert's convective quasi-equilibrium formulation. Among those, probably the most fascinating possibility is to take a vertical integral of the convective-scale moisture for the closure. Use of a convective-scale variable for closure has a particular appeal by not suffering from a loss of predictability of any large-scale variables. That is a main problem with any of the current convective closures, not only for the moisture-convergence based closure as often asserted.

  7. [Laparotomy closure in advanced peritonitis].

    PubMed

    Bensman, V M; Savchenko, Yu P; Shcherba, S N; Golikov, I V; Triandafilov, K V; Chaykin, V V; Pyatakov, S N; Saakyan, A S; Saakyan, E A

    to improve the results of advanced peritonitis management. 743 patients with advanced peritonitis were studied. Patients were divided into 2 groups depending on treatment strategy. Programmed relaparotomy combined with removable draining musculoaponeurotic seams during laparotomy closure decreased mortality from 47.8±2.7% to 24.1±2.3% (p<0.001) and provided 4-fold reduction of postoperative suppuration incidence (p<0.001). Refusal from removable draining musculoaponeurotic seams and use of only cutaneous seams in persistent abdominal hypertension were associated with further decrease of mortality to 15.8±2.7% (p<0.05). Programmed relaparotomy combined with removable draining musculoaponeurotic seams are advisable for advanced peritonitis management. Laparotomy closure with only cutaneous seams is indicated in case of persistent abdominal hypertension. Large eventration always requires abdominal wall repair. APACHE-III scale scores have significant prognostic value in patients with advanced peritonitis.

  8. Military Base Closure: Socioeconomic Impacts

    DTIC Science & Technology

    2005-05-18

    RS22147 May 18, 2005 Military Base Closure: Socioeconomic Impacts Tadlock Cowan Analyst in Rural and Regional Development Policy Resources, Science, and...dire effects that many communities expected. For rural areas, however, the impacts can be greater and the economic recovery much slower. Drawing...from existing studies, this report assesses the potential community impacts and proposals for minimizing those impacts . Background. To better confront

  9. Repository Closure and Sealing Approach

    SciTech Connect

    A.T. Watkins

    2000-06-28

    The scope of this analysis will be to develop the conceptual design of the closure seals and their locations in the Subsurface Facilities. The design will be based on the recently established program requirements for transitioning to the Site Recommendation (SR) design as outlined by ''Approach to Implementing the Site Recommendation Baseline'' (Stroupe 2000) and the ''Monitored Geologic Repository Project Description Document'' (CRWMS M&O 1999b). The objective of this analysis will be to assist in providing a description for the Subsurface Facilities System Description Document, Section 2 and finally to document any conclusions reached in order to contribute and provide support to the SR. This analysis is at a conceptual level and is considered adequate to support the SR design. The final closure barriers and seals for the ventilation shafts, and the north and south ramps will require these openings to be permanently sealed to limit excessive air and water inflows and prevent human intrusion. The major tasks identified with closure in this analysis are: (1) Developing the overall subsurface seal layout and identifying design and operational interfaces for the Subsurface Facilities. (2) Summarizing the general site conditions and general rock characteristic with respect to seal location and describing the seal selected. (3) Identify seal construction materials, methodology of construction and strategic locations including design of the seal and plugs. (4) Discussing methods to prevent human intrusion.

  10. Sampling and monitoring for closure

    USGS Publications Warehouse

    McLemore, V.T.; Russell, C.C.; Smith, K.S.

    2004-01-01

    The Metals Mining Sector of the Acid Drainage Technology Initiative (ADTI-MMS) addresses technical drainage-quality issues related to metal mining and related metallurgical operations, for future and active mines, as well as, for historical mines and mining districts. One of the first projects of ADTI-MMS is to develop a handbook describing the best sampling, monitoring, predicting, mitigating, and modeling of drainage from metal mines, pit lakes and related metallurgical facilities based upon current scientific and engineering practices. One of the important aspects of planning a new mine in today's regulatory environment is the philosophy of designing a new or existing mine or expansion of operations for ultimate closure. The holistic philosophy taken in the ADTI-MMS handbook maintains that sampling and monitoring programs should be designed to take into account all aspects of the mine-life cycle. Data required for the closure of the operation are obtained throughout the mine-life cycle, from exploration through post-closure.

  11. Effectiveness of percutaneous closure of patent foramen ovale for hypoxemia.

    PubMed

    Fenster, Brett E; Nguyen, Bryant H; Buckner, J Kern; Freeman, Andrew M; Carroll, John D

    2013-10-15

    The aim of this study was to evaluate the ability of percutaneous patent foramen ovale (PFO) closure to improve systemic hypoxemia. Although PFO-mediated right-to-left shunt (RTLS) is associated with hypoxemia, the ability of percutaneous closure to ameliorate hypoxemia is unknown. Between 2004 and 2009, 97 patients who underwent PFO closure for systemic hypoxemia and dyspnea that was disproportionate to underlying lung disease were included for evaluation. All patients exhibited PFO-mediated RTLS as determined by agitated saline echocardiography. Procedural success was defined as implantation of a device without major complications and mild or no residual shunt at 6 months. Clinical success was defined as a composite of an improvement in New York Heart Association (NYHA) functional class, reduction of dyspnea symptoms, or decreased oxygen requirement. Procedural success was achieved in 96 of 97 (99%), and clinical success was achieved in 68 of 97 (70%). The presence of any moderate or severe interatrial shunt by agitated saline study (odds ratio [OR] = 4.7; p <0.024), NYHA class at referral (OR = 2.9; p <0.0087), and 10-year increase in age (OR = 1.8; p <0.0017) increased likelihood of clinical success. In contrast, a pulmonary comorbidity (OR = 0.18; p <0.005) and male gender (OR = 0.30; p <0.017) decreased the likelihood of success. In conclusion, based on the largest single-center experience of patients referred for PFO closure for systemic hypoxemia, PFO closure was a mechanically effective procedure with an associated improvement in echocardiographic evidence of RTLS, NYHA functional class, and oxygen requirement. Copyright © 2013 Elsevier Inc. All rights reserved.

  12. Sizing of patent ductus arteriosus in adults for transcatheter closure using the balloon pull-through technique.

    PubMed

    Shafi, Nabil A; Singh, Gagan D; Smith, Thomas W; Rogers, Jason H

    2017-09-25

    To describe a novel balloon sizing technique used during adult transcatheter patent ductus arteriosus (PDA) closure. In addition, to determine the clinical and procedural outcomes in six patients who underwent PDA balloon sizing with subsequent deployment of a PDA occluder device. Transcatheter PDA closure in adults has excellent safety and procedural outcomes. However, PDA sizing in adults can be challenging due to variable defect size, high flow state, or anatomical complexity. We describe a series of six cases where the balloon- pull through technique was successfully performed for PDA sizing prior to transcatheter closure. Consecutive adult patients undergoing adult PDA closure at our institution were studied retrospectively. A partially inflated sizing balloon was pulled through the defect from the aorta into the pulmonary artery and the balloon waist diameter was measured. Procedural success and clinical outcomes were obtained. Six adult patients underwent successful balloon pull-through technique for PDA sizing during transcatheter PDA closure, since conventional angiography often gave suboptimal opacification of the defect. All PDAs were treated with closure devices based on balloon PDA sizing with complete closure and no complications. In three patients that underwent preprocedure computed tomography, the balloon size matched the CT derived measurements. The balloon pull-through technique for PDA sizing is a safe and accurate sizing modality in adults undergoing transcatheter PDA closure. © 2017 Wiley Periodicals, Inc.

  13. Cardiac procedures to prevent stroke: patent foramen ovale closure/left atrial appendage occlusion.

    PubMed

    Freixa, Xavier; Arzamendi, Dabit; Tzikas, Apostolos; Noble, Stephane; Basmadjian, Arsene; Garceau, Patrick; Ibrahim, Réda

    2014-01-01

    Stroke is a major contributor to population morbidity and mortality. Cardiac thromboembolic sources are an important potential cause of stroke. Left atrial appendage (LAA) thromboembolism in association with atrial fibrillation is a major contributor to stroke occurrence, particularly in elderly individuals. Patent foramen ovale (PFO) acts as a potential conduit from the right-sided circulation to the brain, and has been suggested to be an important factor in cryptogenic stroke in the young patients. Advances in interventional cardiology have made it possible to deal with these potential stroke sources (LAA and PFO), but the available methods have intrinsic limitations that must be recognized. Furthermore, the potential value of LAA and PFO closure depends on our ability to identify when the target structure is importantly involved in stroke risk; this is particularly challenging for PFO. This article addresses the clinical use of PFO and LAA closure in stroke prevention. We discuss technical aspects of closure devices and methods, questions of patient selection, and clinical trials evidence. We conclude that for PFO closure, the clinical trials evidence is thus far negative in the broad cryptogenic stroke population, but closure might nevertheless be indicated for selected high-risk patients. LAA closure has an acceptable balance between safety and efficacy for atrial fibrillation patients with high stroke risk and important contraindications to oral anticoagulation. Much more work needs to be done to optimize the devices and techniques, and better define patient selection for these potentially valuable procedures.

  14. Closure of Secundum Atrial Septal Defects With the AMPLATZER Septal Occluder

    PubMed Central

    Owada, Carl Y.; Sang, Charlie J.; Khan, Muhammad; Lim, D. Scott

    2017-01-01

    Background— Prospective data on the medium-term safety and effectiveness of the AMPLATZER Septal Occluder in clinical practice are not available. The objective of this study was to prospectively evaluate the risk of hemodynamic compromise and obtain medium-term survival data on patients implanted with the AMPLATZER Septal Occluder for percutaneous closure of secundum atrial septal defects. Methods and Results— Subjects were enrolled prospectively at 50 US sites and followed for 2 years. Between 2008 and 2012, atrial septal defect closure with the AMPLATZER Septal Occluder was attempted in 1000 patients (aged 0.3–83.6 years, mean 21±22 years). Procedural closure occurred in 97.9%, with 1-month and 2-year closure 98.5% and 97.9%, respectively. Hemodynamic compromise occurred in 6 subjects (0.65%), because of dysrhythmia in 2, device embolization in 1, and cardiac erosion in 3. The rate of cardiac erosion was 0.3% (average 83, range 12–171 days from implant). Conclusions— Closure of atrial septal defect with the AMPLATZER Septal Occluder is safe and effective. The rate of hemodynamic compromise and cardiac erosion is rare. The risk factors for cardiac erosion after device closure are not yet clear. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00650936. PMID:28801537

  15. Three-dimensional color Doppler transesophageal echocardiography for mitral paravalvular leak quantification and evaluation of percutaneous closure success.

    PubMed

    Franco, Eduardo; Almería, Carlos; de Agustín, Jose Alberto; Arreo Del Val, Viviana; Gómez de Diego, José Juan; García Fernández, Miguel Ángel; Macaya, Carlos; Pérez de Isla, Leopoldo; Garcia, Eulogio

    2014-11-01

    Three-dimensional (3D) color Doppler transesophageal echocardiography (TEE) enables accurate planimetry of the effective regurgitant orifice (ERO) of a mitral paravalvular leak (PVL). The aim of this study was to evaluate the usefulness of this method to quantify paravalvular regurgitation and to assess percutaneous PVL closure success, compared with 3D planimetry of PVLs without using color-flow images (3D anatomic regurgitant orifice [ARO]). Forty-six patients (59 mitral PVLs) who underwent 3D TEE to evaluate the indication of PVL closure procedure were retrospectively included. Receiver operating characteristic curves were compared to identify degree III and IV paravalvular regurgitation of 3D color ERO and 3D ARO measures. Forty patients underwent percutaneous PVL closure procedures; analysis was conducted to determine whether the undersizing of the closure devices according to 3D color ERO and 3D ARO measures was associated with PVL closure failure. Three-dimensional ERO measures showed better areas under the curve than 3D ARO measures and correlated better with the degree of paravalvular regurgitation. Three-dimensional color ERO major diameter ≥ 0.65 cm showed a positive predictive value of 87.1% and a negative predictive value of 94% to diagnose degree III and IV paravalvular regurgitation. For the 40 patients who underwent PVL closure procedures, the immediate technical success rate was 76.9%, and 1-year estimated survival was 69.5%. Closure device undersizing according to 3D color ERO length, but not other PVL measurements, was significantly associated with PVL closure failure (P = .007). Three-dimensional ERO was superior to 3D ARO at identifying the presence of degree III and IV paravalvular regurgitation. The undersizing of closure devices according to 3D color ERO length was associated with failed closure procedures. Confirmatory prospective studies are encouraged. Copyright © 2014 American Society of Echocardiography. Published by Elsevier Inc

  16. Roles of real-time three-dimensional transesophageal echocardiography in peri-operation of transcatheter left atrial appendage closure

    PubMed Central

    Zhou, Qing; Song, Hongning; Zhang, Lan; Deng, Qing; Chen, Jinling; Hu, Bo; Wang, Yijia; Guo, Ruiqiang

    2017-01-01

    Abstract Left atrial appendage (LAA) closure is a new treatment option for the prevention of stroke in patients with nonvalvular atrial fibrillation (AF). Conventional 2-dimensional transesophageal echocardiography (2D TEE) has some limitations in the imaging assessment of LAA closure. Real-time 3-dimensional transesophageal echocardiography (RT-3D TEE) allows for detailed morphologic assessment of the LAA. In this study, we aim to determine the clinical values of RT-3D TEE in the periprocedure of LAA closure. Thirty-eight persistent or paroxysmal AF patients with indications for LAA closure were enrolled in this study. RT-3D TEE full volume data of the LAA were recorded before operation to evaluate the anatomic feature, the landing zone dimension, and the depth of the LAA. On this basis, selection of LAA closure device was carried out. During the procedure, RT-3D TEE was applied to guide the interatrial septal puncture, device operation, and evaluate the occlusion effects. The patients were follow-up 1 month and 3 months postclosure. Twenty-eight (73.7%) patients with AF received placement of LAA occlusion device under RT-3D TEE. Eleven cases with single-lobe LAAs were identified using RT-3D TEE, among which 4 showed limited depth. Seventeen cases showed bilobed or multilobed LAA. Seven cases received LAA closure using Lefort and 21 using LAmbre based on the 3D TEE and radiography. The landing zone dimension of the LAA measured by RT-3D TEE Flexi Slice mode was better correlated with the device size used for occlusion (r = 0.90) than 2D TEE (r = 0.88). The interatial septal puncture, the exchange of the sheath, as well as the release of the device were executed under the guidance of RT-3D TEE during the procedure. The average number of closure devices utilized for optimal plugging was (1.11 ± 0.31). There were no clinically unacceptable residual shunts, pericardial effusion, or tamponade right after occlusion. All the patients had the device well

  17. Sustained eye closure slows saccades

    PubMed Central

    Shaikh, Aasef G.; Wong, Aaron L.; Optican, Lance M.; Miura, Kenichiro; Solomon, David; Zee, David S.

    2010-01-01

    Saccadic eye movements rapidly orient the line of sight towards the object of interest. Pre-motor burst neurons (BNs) controlling saccades receive excitation from superior colliculus and cerebellum, but inhibition by omnipause neurons (OPNs) prevents saccades. When the OPNs pause, BNs begin to fire. It has been presumed that part of the BN burst comes from post-inhibitory rebound (PIR). We hypothesized that in the absence of prior inhibition from OPNs there would be no PIR, and thus the increase in initial firing rate of BNs would be reduced. Consequently, saccade acceleration would be reduced. We measured eye movements and showed that sustained eye closure, which inhibits the activity of OPNs and thus hypothetically should weaken PIR, reduced the peak velocity, acceleration, and deceleration of saccades in healthy human subjects. Saccades under closed eyelids also had irregular trajectories; the frequency of the oscillations underlying this irregularity was similar to that of high-frequency ocular flutter (back-to-back saccades) often seen in normal subjects during attempted fixation at straight ahead while eyes are closed. Saccades and quick phases of nystagmus are generated by the same pre-motor neurons, and we found that the quick-phase velocity of nystagmus was also reduced by lid closure. These changes were not due to a mechanical hindrance to the eyes, because lid closure did not affect the peak velocities or accelerations of the eyes in the “slow-phase” response to rapid head movements of comparable speeds to those of saccades. These results indicate a role for OPNs in generating the abrupt onset and high velocities of saccades. We hypothesize that the mechanism involved is PIR in pre-motor burst neurons. PMID:20573593

  18. Clamshell closure for metal drum

    DOEpatents

    Blanton, Paul S

    2014-09-30

    Closure ring to retain a lid in contact with a metal drum in central C-section conforming to the contact area between a lid and the rim of a drum and further having a radially inwardly directed flange and a vertically downwardly directed flange attached to the opposite ends of the C-section. The additional flanges reinforce the top of the drum by reducing deformation when the drum is dropped and maintain the lid in contact with the drum. The invention is particularly valuable in transportation and storage of fissile material.

  19. Closure constraints for hyperbolic tetrahedra

    NASA Astrophysics Data System (ADS)

    Charles, Christoph; Livine, Etera R.

    2015-07-01

    We investigate the generalization of loop gravity's twisted geometries to a q-deformed gauge group. In the standard undeformed case, loop gravity is a formulation of general relativity as a diffeomorphism-invariant SU(2) gauge theory. Its classical states are graphs provided with algebraic data. In particular, closure constraints at every node of the graph ensure their interpretation as twisted geometries. Dual to each node, one has a polyhedron embedded in flat space {{{R}}3}. One then glues them, allowing for both curvature and torsion. It was recently conjectured that q-deforming the gauge group SU(2) would allow us to account for a non-vanishing cosmological constant Λ \

  20. A study of crack closure in fatigue

    NASA Technical Reports Server (NTRS)

    Shih, T. T.; Wei, R. P.

    1973-01-01

    Crack closure phenomenon in fatigue was studied by using a Ti-6Al-4V titanium alloy. The occurrence of crack closure was directly measured by an electrical-potential method, and indirectly by load-strain measurement. The experimental results showed that the onset of crack closure depends on both the stress ratio, and the maximum stress intensity factor. No crack closure was observed for stress ratio, greater than 0.3 in this alloy. A two-dimensional elastic model was used to explain the behavior of the recorded load-strain curves. Closure force was estimated by using this model. Yield level stress was found near the crack tip. Based on this estimated closure force, the crack opening displacement was calculated. This result showed that onset of crack closure detected by electrical-potential measurement and crack-opening-displacement measurement is the same. The implications of crack closure on fatigue crack are considered. The experimental results show that crack closure cannot fully account for the effect of stress ratio, on crack growth, and that it cannot be regarded as the sole cause for delay.

  1. 100-D Ponds closure plan. Revision 1

    SciTech Connect

    Petersen, S.W.

    1997-09-01

    The 100-D Ponds is a Treatment, Storage, and Disposal (TSD) unit on the Hanford Facility that received both dangerous and nonregulated waste. This Closure Plan (Rev. 1) for the 100-D Ponds TSD unit consists of a RCRA Part A Dangerous Waste Permit Application (Rev. 3), a RCRA Closure Plan, and supporting information contained in the appendices to the plan. The closure plan consists of eight chapters containing facility description, process information, waste characteristics, and groundwater monitoring data. There are also chapters containing the closure strategy and performance standards. The strategy for the closure of the 100-D Ponds TSD unit is clean closure. Appendices A and B of the closure plan demonstrate that soil and groundwater beneath 100-D Ponds are below cleanup limits. All dangerous wastes or dangerous waste constituents or residues associated with the operation of the ponds have been removed, therefore, human health and the environment are protected. Discharges to the 100-D Ponds, which are located in the 100-DR-1 operable unit, were discontinued in June 1994. Contaminated sediment was removed from the ponds in August 1996. Subsequent sampling and analysis demonstrated that there is no contamination remaining in the ponds, therefore, this closure plan is a demonstration of clean closure.

  2. Spontaneous closure of congenital coronary artery fistulas.

    PubMed

    Schleich, J M; Rey, C; Gewillig, M; Bozio, A

    2001-04-01

    Six cases of full spontaneous closure of congenital coronary artery fistulas, and one case of near closure, as seen by colour Doppler echocardiography, are presented. It is worth reconsidering the classical view that nearly all cases of spontaneous closure are eligible for surgical or percutaneous correction to prevent the development of significant and potentially fatal complications. As the natural course of coronary artery fistulas is still poorly defined, asymptomatic patients, especially those under 7 years old with small shunts, should be periodically followed up by echocardiography rather than be subjected to operative closure, even by catheterisation.

  3. Successful Percutaneous Retrieval of Embolized Septal Occluder Device from Aortic Arch and Placement of a Newer Septal Occluder Device in Combined Procedure

    PubMed Central

    Gautam, Sandeep; Webel, Richard

    2016-01-01

    Embolization of the Amplatzer Septal Occluder (ASO) device (St. Jude Medical, Minnesota) after percutaneous closure of atrial septal defect (ASD) is a rare and potentially catastrophic complication. Percutaneous retrieval of the embolized device is gaining ground as an acceptable method, although these patients are usually subsequently referred for open surgical closure of the ASD. We present a unique case of percutaneous retrieval embolized ASO device and placement of newer larger ASO device in a single procedure. PMID:28116175

  4. 40 CFR 264.112 - Closure plan; amendment of plan.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 27 2012-07-01 2012-07-01 false Closure plan; amendment of plan. 264... Closure and Post-Closure § 264.112 Closure plan; amendment of plan. (a) Written plan. (1) The owner or operator of a hazardous waste management facility must have a written closure plan. In addition,...

  5. 40 CFR 264.112 - Closure plan; amendment of plan.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 26 2014-07-01 2014-07-01 false Closure plan; amendment of plan. 264... Closure and Post-Closure § 264.112 Closure plan; amendment of plan. (a) Written plan. (1) The owner or operator of a hazardous waste management facility must have a written closure plan. In addition,...

  6. Restoration of eye closure in facial paralysis using implantable electromagnetic actuator.

    PubMed

    Hasmat, Shaheen; Lovell, Nigel H; Suaning, Gregg J; Low, Tsu-Hui Hubert; Clark, Jonathan

    2016-11-01

    The most devastating outcome of facial nerve paralysis is the inability to completely close the eye as it can lead to corneal ulceration and loss of vision. Gravity-assisted eye closure with upper lid loading is commonly used; however it is limited in replicating physiological eye closure to adequately lubricate the cornea. Superior results can be obtained using more advanced reconstructive approaches, however they depend on nerve regrowth which may be unpredictable and prolonged. This report describes a novel technique for creating an active eye closure using an implantable actuator. A generated magnetic field creates lateral movement in an electromagnet that is translated to the eyelid through a sling design. The device is powered wirelessly through a transcutaneous induction link and can be hermetically encapsulated for patient safety. The initial phase of device development is presented including data of a fully functioning prototype and the results of its application in animal and human cadavers.

  7. Percutaneous Closure of an Iatrogenic Aorta to Right Ventricle Fistula Acquired Following Intracardiac Repair

    PubMed Central

    Rajasekhar, Durgaprasad; Vanajakshamma, Velam; Ranganayakulu, Kummaraganti Paramathma

    2016-01-01

    Iatrogenic aortocardiac fistulae have been described rarely following intracardiac repair. This 28 year-old-male presented to our facility with dyspnea going on 20 days after closure of ventricular septal defect (VSD) and resection of subaortic membrane. A communication was noticed between the aorta and the right ventricle (RV) upon transthoracic echocardiography. Cardiac catheterisation revealed a significant shunt and an aortogram revealed a 6 mm communication between aorta and right ventricle. Percutaneous closure of this defect was attempted under local anaesthesia through right femoral access. An alpha arteriovenous loop was formed despite repeated attempts, hence a retrograde approach for device delivery was considered. An 8 mm Amplatzer muscular VSD occluder device was deployed across the defect achieving a complete closure through an 8F delivery sheath. To the best of our knowledge this is the first report of an iatrogenic aorta to RV fistula occurring in a patient following an intracardiac repair which has been successfully treated percutaneously. PMID:27274181

  8. Perioperative closure-related complication rates and cost analysis of barbed suture for closure in TKA.

    PubMed

    Gililland, Jeremy M; Anderson, Lucas A; Sun, Grant; Erickson, Jill A; Peters, Christopher L

    2012-01-01

    The use of barbed suture for surgical closure has been associated with lower operative times, equivalent wound complication rate, and comparable cosmesis scores in the plastic surgery literature. Similar studies would help determine whether this technology is associated with low complication rates and reduced operating times for orthopaedic closures. We compared a running barbed suture with an interrupted standard suture technique for layered closure in primary TKA to determine if the barbed suture would be associated with (1) shorter estimated closure times; (2) lower cost; and (3) similar closure-related perioperative complication rates. We retrospectively compared two-layered closure techniques in primary TKA with either barbed or knotted sutures. The barbed group consisted of 104 primary TKAs closed with running barbed suture. The standard group consisted of 87 primary TKAs closed with interrupted suture. Cost analysis was based on cost of suture and operating room time. Clinical records were assessed for closure-related complications within the 6-week perioperative period. Average estimated closure time was 2.3 minutes shorter with the use of barbed suture. The total closure cost was similar between the groups. The closure-related perioperative complication rates were similar between the groups. Barbed suture is associated with a slightly shorter estimated closure time, although this small difference is of questionable clinical importance. With similar overall cost and no difference in perioperative complications in primary TKA, this closure methodology has led to more widespread use at our institution.

  9. Identification of Selected Child-Resistant Closures (Continuous Thread, Lug-Bayonet, and Snap Closures).

    ERIC Educational Resources Information Center

    Gross, Rosalind L.; White, Harry E.

    This publication describes a selected group of child-resistant closures used in packaging five categories of medicine and household products. The material in the document was collected to train survey personnel to identify closures for a planned household study of the effectiveness of child-resistant packaging. The 39 closures described are of…

  10. 40 CFR 265.1202 - Closure and post-closure care.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... post-closure care. (a) At closure of a magazine or unit which stored hazardous waste under this subpart... estimates for closure, and financial responsibility for magazines or units must meet all of the requirements... as long as it remains in service as a munitions or explosives magazine or storage unit. (b) If,...

  11. 40 CFR 265.1202 - Closure and post-closure care.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... post-closure care. (a) At closure of a magazine or unit which stored hazardous waste under this subpart... estimates for closure, and financial responsibility for magazines or units must meet all of the requirements... as long as it remains in service as a munitions or explosives magazine or storage unit. (b) If,...

  12. 40 CFR 265.1202 - Closure and post-closure care.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... post-closure care. (a) At closure of a magazine or unit which stored hazardous waste under this subpart... estimates for closure, and financial responsibility for magazines or units must meet all of the requirements... as long as it remains in service as a munitions or explosives magazine or storage unit. (b) If,...

  13. Identification of Selected Child-Resistant Closures (Continuous Thread, Lug-Bayonet, and Snap Closures).

    ERIC Educational Resources Information Center

    Gross, Rosalind L.; White, Harry E.

    This publication describes a selected group of child-resistant closures used in packaging five categories of medicine and household products. The material in the document was collected to train survey personnel to identify closures for a planned household study of the effectiveness of child-resistant packaging. The 39 closures described are of…

  14. 40 CFR 265.197 - Closure and post-closure care.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... DISPOSAL FACILITIES Tank Systems § 265.197 Closure and post-closure care. (a) At closure of a tank system, the owner or operator must remove or decontaminate all waste residues, contaminated containment system components (liners, etc.), contaminated soils, and structures and equipment contaminated with waste, and...

  15. 40 CFR 264.197 - Closure and post-closure care.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Tank Systems § 264.197 Closure and post-closure care. (a) At closure of a tank system, the owner or operator must remove or decontaminate all waste residues, contaminated containment system components (liners, etc.), contaminated soils, and structures and equipment contaminated with waste, and manage them...

  16. 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

  17. Accelerating cleanup: Paths to closure

    SciTech Connect

    Edwards, C.

    1998-06-30

    This document was previously referred to as the Draft 2006 Plan. As part of the DOE`s national strategy, the Richland Operations Office`s Paths to Closure summarizes an integrated path forward for environmental cleanup at the Hanford Site. The Hanford Site underwent a concerted effort between 1994 and 1996 to accelerate the cleanup of the Site. These efforts are reflected in the current Site Baseline. This document describes the current Site Baseline and suggests strategies for further improvements in scope, schedule and cost. The Environmental Management program decided to change the name of the draft strategy and the document describing it in response to a series of stakeholder concerns, including the practicality of achieving widespread cleanup by 2006. Also, EM was concerned that calling the document a plan could be misconstrued to be a proposal by DOE or a decision-making document. The change in name, however, does not diminish the 2006 vision. To that end, Paths to Closure retains a focus on 2006, which serves as a point in time around which objectives and goals are established.

  18. Transitional nuclei near shell closures

    SciTech Connect

    Mukherjee, G.

    2014-08-14

    High spin states in Bismuth and Thallium nuclei near the Z = 82 shell closure and Cesium nuclei near the N = 82 shell closure in A = 190 and A = 130 regions, respectively, have been experimentally investigated using heavy-ion fusion evaporation reaction and by detecting the gamma rays using the Indian National Gamma Array (INGA). Interesting shape properties in these transitional nuclei have been observed. The results were compared with the neighboring nuclei in these two regions. The total Routhian surface (TRS) calculations have been performed for a better understanding of the observed properties. In mass region A = 190, a change in shape from spherical to deformed has been observd around neutron number N = 112 for the Bi (Z = 83) isotopes with proton number above the magic gap Z = 82, whereas, the shape of Tl (Z = 81) isotopes with proton number below the magic gap Z = 82 remains stable as a function of neutron number. An important transition from aplanar to planar configuration of angular momentum vectors leading to the occurance of nuclar chirality and magnetic rotation, respectively, has been proposed for the unique parity πh{sub 11/2}⊗νh{sub 11/2} configuration in Cs isotopes in the mass region A ∼ 130 around neutron number N = 79. These results are in commensurate with the TRS calculations.

  19. Higher order turbulence closure models

    NASA Technical Reports Server (NTRS)

    Amano, Ryoichi S.; Chai, John C.; Chen, Jau-Der

    1988-01-01

    Theoretical models are developed and numerical studies conducted on various types of flows including both elliptic and parabolic. The purpose of this study is to find better higher order closure models for the computations of complex flows. This report summarizes three new achievements: (1) completion of the Reynolds-stress closure by developing a new pressure-strain correlation; (2) development of a parabolic code to compute jets and wakes; and, (3) application to a flow through a 180 deg turnaround duct by adopting a boundary fitted coordinate system. In the above mentioned models near-wall models are developed for pressure-strain correlation and third-moment, and incorporated into the transport equations. This addition improved the results considerably and is recommended for future computations. A new parabolic code to solve shear flows without coordinate tranformations is developed and incorporated in this study. This code uses the structure of the finite volume method to solve the governing equations implicitly. The code was validated with the experimental results available in the literature.

  20. 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.

  1. Use of PTFE patch for pericardial closure after minimal invasive LVAD implantation.

    PubMed

    Mohite, Prashant N; Sabashnikov, Anton; Popov, Aron F; Fatullayev, Javid; Simon, André R

    2016-07-01

    The left ventricular assist device (LVAD) is now a routine therapy for advanced heart failure. The thoracotomy approach for LVAD implantation, in which the left ventricle is approached through a pericardial rent, is becoming popular. We demonstrate closure of the pericardial rent with a polytetrafluoroethylene (PTFE) patch and its advantages.

  2. 2005 Base Closure and Realignment Commission Report

    EPA Pesticide Factsheets

    The 2005 Defense Base Closure and Realignment Commission is proud to present its Final Report for your consideration. As required by law, the Commission thoroughly and objectively reviewed the domestic installation closure and realignment recommendations proposed by the Secretary of Defense on May 13, 2005.

  3. 50 CFR 20.26 - Emergency closures.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... wildlife conservation agency, and announcement on local radio and television. (b) Any such closure or... 50 Wildlife and Fisheries 9 2012-10-01 2012-10-01 false Emergency closures. 20.26 Section 20.26 Wildlife and Fisheries UNITED STATES FISH AND WILDLIFE SERVICE, DEPARTMENT OF THE INTERIOR (CONTINUED...

  4. 50 CFR 20.26 - Emergency closures.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... wildlife conservation agency, and announcement on local radio and television. (b) Any such closure or... 50 Wildlife and Fisheries 9 2013-10-01 2013-10-01 false Emergency closures. 20.26 Section 20.26 Wildlife and Fisheries UNITED STATES FISH AND WILDLIFE SERVICE, DEPARTMENT OF THE INTERIOR (CONTINUED...

  5. 50 CFR 20.26 - Emergency closures.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... wildlife conservation agency, and announcement on local radio and television. (b) Any such closure or... 50 Wildlife and Fisheries 8 2011-10-01 2011-10-01 false Emergency closures. 20.26 Section 20.26 Wildlife and Fisheries UNITED STATES FISH AND WILDLIFE SERVICE, DEPARTMENT OF THE INTERIOR (CONTINUED...

  6. 50 CFR 20.26 - Emergency closures.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... wildlife conservation agency, and announcement on local radio and television. (b) Any such closure or... 50 Wildlife and Fisheries 9 2014-10-01 2014-10-01 false Emergency closures. 20.26 Section 20.26 Wildlife and Fisheries UNITED STATES FISH AND WILDLIFE SERVICE, DEPARTMENT OF THE INTERIOR (CONTINUED...

  7. 40 CFR 265.404 - Closure.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES Chemical, Physical, and Biological Treatment § 265.404 Closure. At closure, all hazardous waste and hazardous...

  8. 40 CFR 265.404 - Closure.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES Chemical, Physical, and Biological Treatment § 265.404 Closure. At closure, all hazardous waste and hazardous...

  9. 40 CFR 265.404 - Closure.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES Chemical, Physical, and Biological Treatment § 265.404 Closure. At closure, all hazardous waste and hazardous...

  10. 40 CFR 265.404 - Closure.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES Chemical, Physical, and Biological Treatment § 265.404 Closure. At closure, all hazardous waste and hazardous...

  11. 33 CFR 52.32 - Administrative closure.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Closure § 52.32 Administrative closure. (a) The Chair may administratively close a case after it has been docketed and at any time prior to its consideration by the Board if the Chair determines that: (1) The... been administratively closed by the Chair may resubmit their applications with a request for further...

  12. 33 CFR 52.32 - Administrative closure.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Closure § 52.32 Administrative closure. (a) The Chair may administratively close a case after it has been docketed and at any time prior to its consideration by the Board if the Chair determines that: (1) The... been administratively closed by the Chair may resubmit their applications with a request for further...

  13. 33 CFR 52.32 - Administrative closure.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Closure § 52.32 Administrative closure. (a) The Chair may administratively close a case after it has been docketed and at any time prior to its consideration by the Board if the Chair determines that: (1) The... been administratively closed by the Chair may resubmit their applications with a request for further...

  14. 33 CFR 52.32 - Administrative closure.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Closure § 52.32 Administrative closure. (a) The Chair may administratively close a case after it has been docketed and at any time prior to its consideration by the Board if the Chair determines that: (1) The... been administratively closed by the Chair may resubmit their applications with a request for further...

  15. 33 CFR 52.32 - Administrative closure.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Closure § 52.32 Administrative closure. (a) The Chair may administratively close a case after it has been docketed and at any time prior to its consideration by the Board if the Chair determines that: (1) The... been administratively closed by the Chair may resubmit their applications with a request for further...

  16. 50 CFR 20.26 - Emergency closures.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... wildlife conservation agency, and announcement on local radio and television. (b) Any such closure or... 50 Wildlife and Fisheries 6 2010-10-01 2010-10-01 false Emergency closures. 20.26 Section 20.26 Wildlife and Fisheries UNITED STATES FISH AND WILDLIFE SERVICE, DEPARTMENT OF THE INTERIOR (CONTINUED...

  17. School Closures in Rural Finnish Communities

    ERIC Educational Resources Information Center

    Autti, Outi; Hyry-Beihammer, Eeva Kaisa

    2014-01-01

    The network of small rural schools in Finland has been radically weakened since the global recession of the 1990s. This article focuses on the social role of rural schools and the phenomenon of school closures. Our aim is to look at rural schools from the viewpoint of local residents and examine how they experience school closures. We seek to hear…

  18. 40 CFR 265.381 - Closure.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES Thermal Treatment § 265.381 Closure. At closure, the owner or operator must remove all hazardous waste and hazardous waste residues (including, but not limited to, ash) from the thermal treatment process or equipment....

  19. 40 CFR 265.381 - Closure.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES Thermal Treatment § 265.381 Closure. At closure, the owner or operator must remove all hazardous waste and hazardous waste residues (including, but not limited to, ash) from the thermal treatment process or equipment....

  20. Variations on the Closure of a Set

    ERIC Educational Resources Information Center

    Francis, Richard L.

    1975-01-01

    The author observes that checking the closure property is redundant for most number systems and therefore hard for students to understand. He defines several systems which are not closed, develops two concepts related to closure, and provides many related examples. (SD)

  1. Bilateral angle closure glaucoma following general anaesthesia.

    PubMed

    Raj, K Mohan; Reddy, P Arun Subhash; Kumar, Vikram Chella

    2015-04-01

    Angle closure glaucoma is one of the ophthalmic emergencies and treatment has to be given at the earliest. It is a rare complication of general anesthesia. A female patient underwent Hysterectomy under general anesthesia. Following this, patient developed bilateral angle closure glaucoma. This patient was treated with antiglaucoma medications followed by YAG laser iridotomy and patient regained vision.

  2. Key financial ratios can foretell hospital closures.

    PubMed

    Lynn, M L; Wertheim, P

    1993-11-01

    An analysis of various financial ratios sampled from open and closed hospitals shows that certain leverage, liquidity, capital efficiency, and resource availability ratios can predict hospital closure up to two years in advance of the closure with an accuracy of nearly 75 percent.

  3. Hospital closure: Phoenix, Hydra or Titanic?

    PubMed

    Dunne, T; Davis, S

    1996-01-01

    Very little has been published about the effects of hospital closure in terms of the service, financial or management issues of the process. Attempts through a case-study format to redress the balance and as such represents the reflections of practitioners who have recently undergone the experience of hospital closure and the often neglected issues arising both during and after the process.

  4. Closure of large patent ductus arteriosus in renal failure under echocardiographic guidance without use of radiographic contrast media.

    PubMed

    Sivakumar, Kothandam; Bhagyavathy, Anpon; Gnanapragasam, Francis

    2009-01-01

    Large patent ductus arteriosus with large left-to-right shunt results in heart failure, and if untreated, leads to multiorgan dysfunction. Use of radiographic iodinated contrast media for angiogram during transcatheter duct closure may aggravate preexistent renal dysfunction. Aortogram with contrast media was avoided in a patient with renal failure, and echocardiogram guided deployment of duct occluder device in the cardiac catheterization laboratory for closure of a large duct. This article highlights use of a nitinol-based occluder that employs nonporous polytetrafluoroethylene fabric to aid in instantaneous duct closure.

  5. To close or not to close: contemporary indications for patent foramen ovale closure.

    PubMed

    Zier, Lucas S; Sievert, Horst; Mahadevan, Vaikom S

    2016-11-01

    Patent foramen ovale (PFO) is a common congenital cardiac abnormality and that has been associated with several disease processes including transient ischemic attacks (TIA), stroke, migraine headaches with aura, decompression sickness, platypnea-orthodeoxia syndrome, and shunt induced cyanosis. Controversy exists regarding closure of PFO as a therapeutic treatment modality for these disease processes. This review addresses the contemporary clinical indications for PFO closure. Areas covered: We conducted a comprehensive literature search of contemporary research studies focusing on randomized trials and meta-analyses comparing medical therapy and device closure of PFOs for the treatment of PFO associated clinical syndromes. We synthesized this literature into a review addressing indications for PFO closure in stroke, TIA, migraine headaches with aura, decompression sickness, platypnea-orthodeoxia syndrome, and shunt induced cyanosis. Expert commentary: Because in many PFO associated conditions it can be difficult to determine the degree to which the PFO is a causative factor in the disease process, we recommend a comprehensive diagnostic evaluation to exclude other obvious etiologies of PFO associated conditions before implicating the PFO and proceeding with closure. However in the properly selected patient population there is growing clinical experience and experimental evidence suggesting that closure of PFO is a safe and effective treatment modality.

  6. Closure Report for Corrective Action Unit 426: Cactus Spring Waste Trenches, Tonopah Test Range, Nevada

    SciTech Connect

    Dave D. Madsen

    1998-08-08

    This closure report provides the documentation for closure of the Cactus Spring Waste Trenches Corrective Action Unit (CAU) 426. The site is located on the Tonopah Test Range,approximately 225 kilometers (140 miles) northwest of Las Vegas, Nevada. CAU 426 consists of one Corrective Action Site which is comprised of four waste trenches. The trenches were excavated to receive solid waste generated in support of Operation Roller Coaster, primarily the Double Tracks Test in 1963, and were subsequently backfilled. The Double Tracks Test involved the use of live animals to assess the biological hazards associated with the non-nuclear detonation of plutonium-bearing devices (i.e., inhalation uptake of plutonium aerosol) (DOE, 1996). The remedial alternative proposed Nevada Division of Environmental Protection proposed the capping method. The closure activities were completed in accordance with the approved Corrective Action Plan and consisted of constructing an engineered cover in the ar ea of the trenches, constructing/planning a vegetative cover, installing a perimeter fence and signs, implementing restrictions on future use, and preparing a post-closure monitoring plan. Closure activities for CAU 426 have been completed in accordance with the Nevada Division of Environmental Protection approved Corrective Action Plan as documented in this Closure Report.

  7. Laceration of the Common Femoral Artery Following Deployment of the StarClose{sup TM} Vascular Closure System

    SciTech Connect

    Gonsalves, Michael Walkden, Miles Belli, Anna Maria

    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.

  8. PLAN FOR CLOSURE OF HANFORDS CENTRAL PLATEAU

    SciTech Connect

    AUSTIN, B.A.

    2004-12-15

    This paper summarizes an approach to reduce risk to the public and environment through accelerated closure of Hanford's Central Plateau, based on a plan developed by Fluor Hanford and submitted to the Department of Energy (DOE)-Richland Office, for consideration, in September, 2004. This plan provides a framework and starting point for discussions with regulators and further planning for closure activities on the Plateau. The closure strategy and approach required developing a full inventory of items needing closure as well as identifying and defining technical and regulatory approaches that were compatible with current regulatory processes, reduce risks, and met DOE objectives. This effort, and the paper that follows, integrates closure activities among several contractors and two DOE field offices.

  9. Closure for milliliter scale bioreactor

    DOEpatents

    Klein, David L.; Laidlaw, Robert D.; Andronaco, Gregory; Boyer, Stephen G.

    2010-12-14

    A closure for a microreactor includes a cap that is configured to be inserted into a well of the microreactor. The cap, or at least a portion of the cap, is compliant so as to form a seal with the well when the cap is inserted. The cap includes an aperture that provides an airway between the inside of the well to the external environment when the cap is inserted into the well. A porous plug is inserted in the aperture, e.g., either directly or in tube that extends through the aperture. The porous plug permits gas within the well to pass through the aperture while preventing liquids from passing through to reduce evaporation and preventing microbes from passing through to provide a sterile environment. A one-way valve may also be used to help control the environment in the well.

  10. 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

  11. Efficiency of transcatheter patent foramen ovale closure in children after paradoxical embolism events.

    PubMed

    Wawrzyńczyk, Maciej; Gałeczka, Michał; Karwot, Blandyna; Knop, Mateusz; Białkowski, Jacek

    2016-01-01

    Patent foramen ovale (PFO) may result in a cerebrovascular event - a presumed paradoxical embolism (PE). However, the presence of this phenomenon among paediatric patients was rarely evaluated. Transcatheter PFO closure was considered to be a method of treatment in such patients. For evaluation clinical data and long-term outcome, we reviewed records of patients below 18 years of age, with history of cerebrovascular event related to PE, who underwent procedure of percutaneous PFO closure in years 1999-2014 in our department. Among 230 patients with cerebrovascular events who had PFO closed percutaneously, seven children (aged 12-16 years, five male) were selected. Indications for closure were cryptogenic stroke in two patients and transient ischaemic attack (TIA) in five patients. Diagnosis of PFO was established by transthoracic echocardiography, with right-to-left shunt (RLS) through PFO confirmed by transoesophageal echocardiography. Contrast transcranial Doppler (c-TCD) was performed preprocedurally in four patients, revealing significant RLS. For percutaneous closure of PFO different occluders (Starflex, Amplatzer PFO devices, Cardio-O-Fix) were used. Closure was successfully completed in all patients and no procedure-related complications were observed. Postprocedural c-TCD six months after closure revealed no significant RLS. During follow-up (3 to 10 years) one patient had an episode of recurrent TIA; however, in this patient paroxysmal atrial fibrillation was found during the follow-up period. Cerebral embolism due to PFO is uncommon in children. Transcatheter PFO closure in this group of patients is a safe and effective procedure. C-TCD is plausible technique for detection RLS and monitoring PFO closure efficacy in this group of patients.

  12. Long-term outcome after transcatheter closure of postinfarction ventricular septal rupture.

    PubMed

    Heiberg, Johan; Hjortdal, Vibeke Elisabeth; Nielsen-Kudsk, Jens Erik

    2014-10-01

    We report the long-term all-cause mortality and procedure-related complication rate following transcatheter closure of postinfarction ventricular septal rupture (VSR) in a single tertiary center. VSR is an exceedingly serious and deathly complication to myocardial infarction. Surgical closure has previously been the treatment of choice, but in the last decade a transcatheter approach has gained ground. However, reports on long-term survival are still sparse and experience is often restricted to large tertiary centers with high flow of patients. From January 2000 to April 2013, 9 patients underwent transcatheter closure of a VSR at Aarhus University Hospital. Primary device closure was chosen mainly because of significant risk factors against surgery. Our major endpoints were 30-day, 1-year, and 5-year mortality and years of survival until time of evaluation. Our cohort had a mean age of 75.1 ± 8.4 years, and the median time from VSR to closure was 16 days (2-346). The 30-day, 1-year, and 5-year mortality rates were 11.1%, 33.3%, and 62.5%, respectively. Mean time of postprocedural survival was 4.6 ± 4.4 years at the time of review. Three patients were still alive at the time of review, 1 with a shock-index <1 at the time of VSR closure. As a single medium-sized tertiary center, we report lower short- and long-term mortality rates compared with most published data on outcome after surgical closure. Our results are comparable to the few previously published reports on transcatheter closure of postinfarction VSRs. © 2014, Wiley Periodicals, Inc.

  13. Complications and mid-term outcome after percutaneous patent foramen ovale closure in patients with cryptogenic stroke

    PubMed Central

    Luermans, J.G.L.M.; Post, M.C.; Plokker, H.W.M.; ten Berg, J.M.; Suttorp, M.J.

    2008-01-01

    Background: Percutaneous patent foramen ovale (PFO) closure seems to reduce the risk of recurrent thromboembolism. We report the safety and efficacy of percutaneous PFO closure in our centre. Methods: All patients, >16 years of age, who underwent a percutaneous PFO closure in our centre were included. Reoccurrence of stroke, transient ischaemic attack (TIA) and peripheral thromboembolism were assessed. Periprocedural and midterm complications are reported. Results: Eighty-three consecutive patients (mean age 49±13 years) were included. Indications for PFO closure were cryptogenic stroke (59.0%), TIA (33.7%), peripheral embolism (2.4%) and other (4.8%). For PFO closure, a Cardioseal/Starflex device was used in 63 patients and an Amplatzer PFO occluder device in 20 patients. Stroke recurred in 1.2%, TIA in 3.6%, peripheral embolism in 0% during a mean follow-up of 1.9±1.2 years. Major periprocedural complications occurred in 1.2%. The mid-term complication rate was 2.4% and only consisted of minor complications. During follow-up, a residual right-to-left shunt was present in 5.7% of the patients. No significant difference in outcome, complications or residual shunting could be documented between the two device types. Conclusion: In our centre, the percutaneous closure of a PFO seems to be a safe and effective procedure to prevent recurrence of paradoxical thrombo-embolic events. (Neth Heart J 2008;16:332-6.) PMID:18958256

  14. Analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience database for adverse events involving Amplatzer septal occluder devices and comparison with the Society of Thoracic Surgery congenital cardiac surgery database.

    PubMed

    DiBardino, Daniel J; McElhinney, Doff B; Kaza, Aditya K; Mayer, John E

    2009-06-01

    Amplatzer (AGA Medical Corporation, Plymouth, Minn) septal and vascular occluder devices have significantly altered the care of patients with congenital heart disease. The relative frequency and consequence of complications resulting from the attempted placement of such devices, however, have not been well assessed. The purpose of this study is to use large databases to assess the frequency and severity of such complications and compare them with those of surgical atrial septal defect closure. The US Food and Drug Administration Manufacturer and User Facility Device Experience database was quarried for all adverse events for Amplatzer septal occluder devices, which were categorized and analyzed with particular emphasis on management and outcome. The Society of Thoracic Surgery database was likewise quarried for the same data regarding atrial septal defect closures over a contemporaneous time period. By using a literature-derived denominator for total Amplatzer implant numbers, the results of the 2 therapies were compared. Since July 1, 2002, 223 adverse events in patients undergoing Amplatzer atrial septal defect closure were submitted to the Food and Drug Administration, resulting in 17 deaths (7.6%) and 152 surgical rescue operations (68.2%). Society of Thoracic Surgery data demonstrated 1537 primary operations with 2 deaths (0.13%) and 6 reoperations (0.39%). By extrapolating on published estimates of Amplatzer implantation to provide an implant denominator (n = 18,333), there was no difference between overall mortality for surgical (0.13%) and device closure (0.093%, P = .649). Rescue operation for device adverse events (0.83%) was 2.1 times more likely than reoperation for surgical closure (0.39%, P = .063). Mortality per adverse event was higher for device closure (7.6%) than for surgical closure (1.2%, P = .004), and the need for surgery per adverse event was higher for device closure (68.2%) than for surgical closure (3.6%, P < .001). The mortality for

  15. Analytic closures for M1 neutrino transport

    DOE PAGES

    Murchikova, E. M.; Abdikamalov, E.; Urbatsch, T.

    2017-04-25

    Carefully accounting for neutrino transport is an essential component of many astrophysical studies. Solving the full transport equation is too expensive for most realistic applications, especially those involving multiple spatial dimensions. For such cases, resorting to approximations is often the only viable option for obtaining solutions. One such approximation, which recently became popular, is the M1 method. It utilizes the system of the lowest two moments of the transport equation and closes the system with an ad hoc closure relation. The accuracy of the M1 solution depends on the quality of the closure. Several closures have been proposed in themore » literature and have been used in various studies. We carry out an extensive study of these closures by comparing the results of M1 calculations with precise Monte Carlo calculations of the radiation field around spherically symmetric protoneutron star models. We find that no closure performs consistently better or worse than others in all cases. The level of accuracy that a given closure yields depends on the matter configuration, neutrino type and neutrino energy. As a result, given this limitation, the maximum entropy closure by Minerbo on average yields relatively accurate results in the broadest set of cases considered in this work.« less

  16. Analytic closures for M1 neutrino transport

    NASA Astrophysics Data System (ADS)

    Murchikova, E. M.; Abdikamalov, E.; Urbatsch, T.

    2017-08-01

    Carefully accounting for neutrino transport is an essential component of many astrophysical studies. Solving the full transport equation is too expensive for most realistic applications, especially those involving multiple spatial dimensions. For such cases, resorting to approximations is often the only viable option for obtaining solutions. One such approximation, which recently became popular, is the M1 method. It utilizes the system of the lowest two moments of the transport equation and closes the system with an ad hoc closure relation. The accuracy of the M1 solution depends on the quality of the closure. Several closures have been proposed in the literature and have been used in various studies. We carry out an extensive study of these closures by comparing the results of M1 calculations with precise Monte Carlo calculations of the radiation field around spherically symmetric protoneutron star models. We find that no closure performs consistently better or worse than others in all cases. The level of accuracy that a given closure yields depends on the matter configuration, neutrino type and neutrino energy. Given this limitation, the maximum entropy closure by Minerbo on average yields relatively accurate results in the broadest set of cases considered in this work.

  17. Factors Associated with Increasing Nursing Home Closures

    PubMed Central

    Castle, Nicholas G; Engberg, John; Lave, Judith; Fisher, Andrew

    2009-01-01

    Purpose We determine the rate of nursing home closures for 7 years (1999–2005) and examine internal (e.g., quality), organizational (e.g., chain membership), and external (e.g., competition) factors associated with these closures. Design and Method The names of the closed facilities and dates of closure from state regulators in all 50 states were obtained. This information was linked to the Online Survey, Certification, and Reporting data, which contains information on internal, organizational, and market factors for almost all nursing homes in the United States. Results One thousand seven hundred and eighty-nine facilities closed over this time period (1999–2005). The average annual rate of closure was about 2 percent of facilities, but the rate of closure was found to be increasing. Nursing homes with higher rates of deficiency citations, hospital-based facilities, chain members, small bed size, and facilities located in markets with high levels of competition were more likely to close. High Medicaid occupancy rates were associated with a high likelihood of closure, especially for facilities with low Medicaid reimbursement rates. Implications As states actively debate about how to redistribute long-term care services/dollars, our findings show that they should be cognizant of the potential these decisions have for facilitating nursing home closures. PMID:19674434

  18. The impact of a needle exchange's closure.

    PubMed

    Broadhead, R S; van Hulst, Y; Heckathorn, D D

    1999-01-01

    The Windham, Connecticut, needle exchange closed in May 1997 after becoming embroiled in a public controversy in which it was blamed for the city's drug problem, discarded syringes, and even the economic decline of the city itself. The authors interviewed injection drug users and conducted a community survey of discarded drug paraphernalia to explore the effects of the needle exchange's closure. After the needle exchange was closed in March 1997, the authors re-recruited former participants in an AIDS prevention research project, the majority of whom were clients of the needle exchange. The authors analyzed responses from these respondents' pre-closure interviews and from III post-closure initial interviews and 78 post-closure follow-up interviews as well as data on discarded syringes and "dope bags". Following the closure of the needle exchange, significant increases were found in the percentage of respondents who reported an unreliable source as their primary source of syringes, in respondents' reports of the frequency of reusing syringes, and in the percentage of respondents who reported sharing of syringes. Surveys of outdoor drug-use areas found that the closure of the needle exchange did not reduce the volume of discarded syringes and other drug-injection debris. The problems in Windham that led to the closure of the exchange still remain, and the city's drug injectors are engaging in higher levels of HIV risk behavior.

  19. Intracardiac echocardiography to guide percutaneous closure of atrial baffle defects.

    PubMed

    Armstrong, Ehrin J; Kwa, Andrew T; Bhat, Aarti; Romick, Benjamin; Smith, Thomas; Rogers, Jason H

    2012-09-01

    Patients with complex congenital heart disease may require surgical construction of interatrial baffles to shunt blood between atria. Long-term complications of these procedures may include stenosis or leak of the baffle, typically along the suture line. There are limited data on transcatheter management and intraprocedural imaging of these anatomically complex lesions. We describe three cases of adults who each presented with baffle leaks more than 20 years after surgical construction of an atrial baffle. In each case, intracardiac echocardiography was essential for intraprocedural guidance, sizing of the defect, and successful percutaneous deployment of an Amplatzer septal occluder device to close the baffle leak. One patient had a baffle leak along the inferior surface of the baffle suture line; the second patient had a baffle leak along the superior border with the left atrium; the third patient had a leak along the sutures of surgical shunt for an anomalous pulmonary vein. Percutaneous closure was successful in all cases, with deployment of an Amplatzer occluder device in each case. Intracardiac echocardiography may be may be useful for procedural guidance during percutaneous closure of atrial baffle defects.

  20. Access and closure of the left ventricular apex: state of play.

    PubMed

    Ziegelmueller, Johannes Amadeus; Lange, Rüdiger; Bleiziffer, Sabine

    2015-09-01

    Calcific aortic stenosis is the most frequent manifestation of valvular heart disease. The preferred treatment for patients of all age groups is surgical aortic valve replacement. Recently, transcatheter aortic valve implantation (TAVI) has become the standard of care for patients that are deemed to be at high risk for open heart surgery. The most common access route for TAVI is the retrograde transfemoral (TF) approach, followed by the antegrade transapical (TA) approach. Both access routes have distinct indications. While the TF route is least invasive and the access of choice at most centers, the apical route is used complementary in patients with poor femoral access. In addition, the TA approach holds various benefits such as a short distance from the operator to the annulus facilitating exact positioning of the valve and the possibility to accommodate larger sheaths. Furthermore, the TA approach not only provides direct access to the aortic valve but also the mitral valve allowing for a wide range of interventions. Various apical closure devices are currently being developed under the premise of increasing overall safety of the TA-TAVI approach by further standardizing the procedure, alleviating left ventricular access and minimizing the risk of complications, such as apical bleeding. The aim of this article is to give an overview of current devices for apical closure. The ideal apical closure device should be easy to put in place, leave a minimum of foreign material, provide complete hemostasis and have a minimal risk of displacement. So far the range of commercially available devices in Europe is very limited with only one CE-certified device on the market and one device that is expected to receive CE-certification soon. Off-the-shelf closure devices could help flatten the initial operator learning curve and facilitate a safe apical access, ultimately leading to an entirely percutaneous TA-TAVI approach.

  1. Access and closure of the left ventricular apex: state of play

    PubMed Central

    Ziegelmueller, Johannes Amadeus; Lange, Rüdiger

    2015-01-01

    Calcific aortic stenosis is the most frequent manifestation of valvular heart disease. The preferred treatment for patients of all age groups is surgical aortic valve replacement. Recently, transcatheter aortic valve implantation (TAVI) has become the standard of care for patients that are deemed to be at high risk for open heart surgery. The most common access route for TAVI is the retrograde transfemoral (TF) approach, followed by the antegrade transapical (TA) approach. Both access routes have distinct indications. While the TF route is least invasive and the access of choice at most centers, the apical route is used complementary in patients with poor femoral access. In addition, the TA approach holds various benefits such as a short distance from the operator to the annulus facilitating exact positioning of the valve and the possibility to accommodate larger sheaths. Furthermore, the TA approach not only provides direct access to the aortic valve but also the mitral valve allowing for a wide range of interventions. Various apical closure devices are currently being developed under the premise of increasing overall safety of the TA-TAVI approach by further standardizing the procedure, alleviating left ventricular access and minimizing the risk of complications, such as apical bleeding. The aim of this article is to give an overview of current devices for apical closure. The ideal apical closure device should be easy to put in place, leave a minimum of foreign material, provide complete hemostasis and have a minimal risk of displacement. So far the range of commercially available devices in Europe is very limited with only one CE-certified device on the market and one device that is expected to receive CE-certification soon. Off-the-shelf closure devices could help flatten the initial operator learning curve and facilitate a safe apical access, ultimately leading to an entirely percutaneous TA-TAVI approach. PMID:26543601

  2. Primary closure versus delayed closure for non bite traumatic wounds within 24 hours post injury.

    PubMed

    Eliya, Martha C; Banda, Grace W

    2011-09-07

    Acute traumatic wounds are one of the common reasons why people present to the emergency department. Primary closure has traditionally been reserved for traumatic wounds presenting within six hours of injury and considered 'clean' by the attending surgeon, with the rest undergoing delayed primary closure as a means of controlling wound infection. Primary closure has the potential benefit of rapid wound healing but poses the potential threat of increased wound infection. There is currently no evidence to guide clinical decision-making on the best timing for closure of traumatic wounds. To determine the effect on time to healing of primary closure versus delayed closure for non bite traumatic wounds presenting within 24 hours post injury. To explore the adverse effects of primary closure compared with delayed closure for non bite traumatic wounds presenting within 24 hours post injury. We searched the Cochrane Wounds Group Specialised Register (searched 14 July 2011); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 3); Ovid MEDLINE (1950 to July Week 1 2011); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, July 13, 2011); Ovid EMBASE (1980 to 2011 Week 27); and EBSCO CINAHL (1982 to 14 July 2011). There were no restrictions with respect to language, date of publication or study setting. Randomised controlled trials comparing primary closure with delayed closure of non bite traumatic wounds. Two review authors independently evaluated the results of the searches against the inclusion criteria. No studies met the inclusion criteria for this review. Since no studies met the inclusion criteria, neither a meta-analysis nor a narrative description of studies was possible. There is currently no systematic evidence to guide clinical decision-making regarding the timing for closure of traumatic wounds. There is a need for robust research to investigate the effect of primary closure compared with delayed closure for non

  3. Primary closure versus delayed closure for non bite traumatic wounds within 24 hours post injury.

    PubMed

    Eliya-Masamba, Martha C; Banda, Grace W

    2013-10-22

    Acute traumatic wounds are one of the common reasons why people present to the emergency department. Primary closure has traditionally been reserved for traumatic wounds presenting within six hours of injury and considered 'clean' by the attending surgeon, with the rest undergoing delayed primary closure as a means of controlling wound infection. Primary closure has the potential benefit of rapid wound healing but poses the potential threat of increased wound infection. There is currently no evidence to guide clinical decision-making on the best timing for closure of traumatic wounds. To determine the effect on time to healing of primary closure versus delayed closure for non bite traumatic wounds presenting within 24 hours post injury. To explore the adverse effects of primary closure compared with delayed closure for non bite traumatic wounds presenting within 24 hours post injury. In May 2013, for this first update we searched the Cochrane Wounds Group Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. There were no restrictions with respect to language, date of publication or study setting. Randomised controlled trials comparing primary closure with delayed closure of non bite traumatic wounds. Two review authors independently evaluated the results of the searches against the inclusion criteria. No studies met the inclusion criteria for this review. Since no studies met the inclusion criteria, neither a meta-analysis nor a narrative description of studies was possible. There is currently no systematic evidence to guide clinical decision-making regarding the timing for closure of traumatic wounds. There is a need for robust research to investigate the effect of primary closure compared with delayed closure for non bite traumatic wounds presenting within 24 hours of injury.

  4. Closure of a broncho-pleural fistula using an atrial septal defect occluder.

    PubMed

    Pasley, Thomas; Ruygrok, Peter N; Kang, Nicolas; O'Carroll, Mark; Kolbe, John; Morrice, David

    2014-03-01

    Broncho-pleural fistulae (BPF) are recognised as a rare complication following pneumonectomy. We describe a patient, who after failing conservative treatment, underwent closure of a persistent fistula with an atrial septal defect (ASD) occluder. Additionally we review the literature regarding management of BPF and the emerging role of cardiac defect closure devices as a possible treatment option. Copyright © 2013 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

  5. 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

    2017-08-21

    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.

  6. Yucca Mountain Waste Package Closure System

    SciTech Connect

    Herschel Smartt; Arthur Watkins; David Pace; Rodney Bitsoi; Eric Larsen; Timothy McJunkin; Charles Tolle

    2006-04-01

    The current disposal path for high-level waste is to place the material into secure waste packages that are inserted into a repository. The Idaho National Laboratory has been tasked with the development, design, and demonstration of the waste package closure system for the repository project. The closure system design includes welding three lids and a purge port cap, four methods of nondestructive examination, and evacuation and backfill of the waste package, all performed in a remote environment. A demonstration of the closure system will be performed with a full-scale waste package.

  7. Yucca Mountain Waste Package Closure System

    SciTech Connect

    shelton-davis; Colleen Shelton-Davis; Greg Housley

    2005-10-01

    The current disposal path for high-level waste is to place the material into secure waste packages that are inserted into a repository. The Idaho National Laboratory has been tasked with the development, design, and demonstration of the waste package closure system for the repository project. The closure system design includes welding three lids and a purge port cap, four methods of nondestructive examination, and evacuation and backfill of the waste package, all performed in a remote environment. A demonstration of the closure system will be performed with a full-scale waste package.

  8. Three-dimensional crack closure behavior

    NASA Technical Reports Server (NTRS)

    Dawicke, D. S.; Grandt, A. F., Jr.; Newman, J. C., Jr.

    1990-01-01

    A crack closure measurement technique involving fatigue striations was used to produce a three-dimensional crack opening load profile for 2024-T351 aluminum alloy. The crack opening load profile, determined through the specimen thickness, was compared with crack opening load measurements made with strain gages and displacement gages. The results of this study indicate that a significant three-dimensional variation in crack closure behavior occurs in the alloy examined. An understanding of this phehomenon is important in understanding crack growth behavior, predicting crack shape changes, and interpreting 'standard' crack closure measurement techniques.

  9. Micro environmental sensing device

    DOEpatents

    Polosky, Marc A.; Lukens, Laurance L.

    2006-05-02

    A microelectromechanical (MEM) acceleration switch is disclosed which includes a proof mass flexibly connected to a substrate, with the proof mass being moveable in a direction substantially perpendicular to the substrate in response to a sensed acceleration. An electrode on the proof mass contacts one or more electrodes located below the proof mass to provide a switch closure in response to the sensed acceleration. Electrical latching of the switch in the closed position is possible with an optional latching electrode. The MEM acceleration switch, which has applications for use as an environmental sensing device, can be fabricated using micromachining.

  10. 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.

  11. Thromboembolism Prevention via Transcatheter Left Atrial Appendage Closure with Transeosophageal Echocardiography Guidance

    PubMed Central

    Palios, John; Paraskevaidis, Ioannis

    2014-01-01

    Atrial fibrillation (AF) is an independent risk factor for stroke. Anticoagulation therapy has a risk of intracerebral hemorrhage. The use of percutaneous left atrial appendage (LAA) closure devices is an alternative to anticoagulation therapy. Echocardiography has a leading role in LAA closure procedure in patient selection, during the procedure and during followup. A comprehensive echocardiography study is necessary preprocedural in order to identify all the lobes of the LAA, evaluate the size of the LAA ostium, look for thrombus or spontaneous echo contrast, and evaluate atrial anatomy, including atrial septal defect and patent foramen ovale. Echocardiography is used to identify potential cardiac sources of embolism, such as atrial septal aneurysm, mitral valve disease, and aortic debris. During the LAA occlusion procedure transeosophageal echocardiography provides guidance for the transeptal puncture and monitoring during the release of the closure device. Procedure-related complications can be evaluated and acceptable device release criteria such as proper position and seating of the occluder in the LAA, compression, and stability can be assessed. Postprocedural echocardiography is used for followup to assess the closure of the LAA ostium. This overview paper describes the emerging role of LAA occlusion procedure with transeosophageal echocardiography guidance as an alternative to anticoagulation therapy in patients with AF. PMID:24672720

  12. Percutaneous closure of post-myocardial infarction ventricular septal rupture - A single centre experience.

    PubMed

    Premchand, Rajendra Kumar; Garipalli, Ravikanth; Padmanabhan, T N C; Manik, Geetesh

    2017-04-01

    Post-infarction ventricular septal rupture (VSR) is a rare but lethal mechanical complication of an acute myocardial infarction (AMI). Survival to 1 month without intervention is 6%. Given high surgical mortality, transcatheter closure has emerged as a potential strategy in selected cases. Indian data on percutaneous device closure of post AMI-VSR is scarce hence we report our single-centre experience with ASD occluder device (Amplatzer and lifetech) for closure of post-AMI VSR. In this single-centre, retrospective, cohort study, patients who underwent transcatheter closure of post-MI VSR between 2005 and 2015 at KIMS Hospital were included. Primary outcome was mortality rate at 30 days. Seven patients were included in the study (mean age, 58.29±9.8 years). 5 patients had anterior wall myocardial infarction (AWMI) & 2 had inferior wall myocardial infarction (IWMI). None of the patients received thrombolytic therapy. Device was successfully placed in 5 patients (71.4%) with minimal residual shunt in 2 patients (40%). Out of 7 cases 2 patients survived (29% survival rate) and are doing well on follow up at 1 and 5 years respectively. Cardiogenic shock, IWMI and serpigenious form of VSR were associated with poor outcomes. Delayed revascularization (PCI) was associated with better outcomes. Percutaneous closure is a potential technique in a selected group of patients. The presence of cardiogenic shock, IWMI and serpigeneous form of VSR constitutes important risk factors for mortality. Device implantation is in general successful with few procedure-related complications and should be applied on a case-by-case basis. Copyright © 2016. Published by Elsevier B.V.

  13. Retrieval of embolized left atrial appendage devices.

    PubMed

    Fahmy, Peter; Eng, Lim; Saw, Jacqueline

    2016-09-28

    Percutaneous left atrial appendage (LAA) closure is gaining interest as an alternative option for prevention of strokes in patients with Atrial Fibrillation (AF), especially for those with contraindications to anticoagulation. Complications from these procedures are well described in the medical literature. LAA closures may lead to pericardial effusion, device-associated thrombus, and device embolization. Understanding the reasons for embolization, strategies to avoid embolization, and the techniques for retrieval of LAA devices (ACP/AMULET and WATCHMAN) should be appreciated by endovascular implanters. We describe two cases of LAA device embolization that were both successfully retrieved percutaneously and other percutaneous techniques to safely retrieve embolized LAA devices. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  14. TECHNICAL ASPECTS OF UNDERGROUND STORAGE TANK CLOSURE

    EPA Science Inventory

    The overall objective of the study was to develop a deeper understanding of UST residuals at closure: their quantities, origins, physical/chemical properties, ease of removal by various cleaning methods, and their environmental mobility and persistence. The investigation covered ...

  15. Plasma-cathode-initiated vacuum gap closure

    SciTech Connect

    Sampayan, S.E.; Gurbaxani, S.H. ); Buttram, M.T. )

    1990-09-01

    The properties of vacuum gap closure initiated by a plasma cathode are presented. The plasma cathode consisted of approximately 60 surface flashover sites distributed over a 10-cm{sup 2} area. Vacuum gap dimensions were 1{times}7.5 cm in diameter. Faraday cup measurements indicated an ion density greater than 10{sup 12} cm{sup {minus}3}, which was controllable by the amplitude of the initiating high-voltage pulse. Although the field-free expansion velocity of the plasma was measured to be 7 cm/{mu}s, plasma-cathode-initiated closure of the vacuum gap indicated closure speeds on the order of 0.5 cm/{mu}s. Also, increased injected ion density and increased anode-cathode potential resulted in increased closure velocity.

  16. Cavity closure arrangement for high pressure vessels

    DOEpatents

    Amtmann, Hans H.

    1981-01-01

    A closure arrangement for a pressure vessel such as the pressure vessel of a high temperature gas-cooled reactor wherein a liner is disposed within a cavity penetration in the reactor vessel and defines an access opening therein. A closure is adapted for sealing relation with an annular mounting flange formed on the penetration liner and has a plurality of radially movable locking blocks thereon having outer serrations adapted for releasable interlocking engagement with serrations formed internally of the upper end of the penetration liner so as to effect high strength closure hold-down. In one embodiment, ramping surfaces are formed on the locking block serrations to bias the closure into sealed relation with the mounting flange when the locking blocks are actuated to locking positions.

  17. Reliability assessment of underground shaft closure

    SciTech Connect

    Fossum, A.F.

    1994-12-31

    The intent of the WIPP, being constructed in the bedded geologic salt deposits of Southeastern New Mexico, is to provide the technological basis for the safe disposal of radioactive Transuranic (TRU) wastes generated by the defense programs of the United States. In determining this technological basis, advanced reliability and structural analysis techniques are used to determine the probability of time-to-closure of a hypothetical underground shaft located in an argillaceous salt formation and filled with compacted crushed salt. Before being filled with crushed salt for sealing, the shaft provides access to an underground facility. Reliable closure of the shaft depends upon the sealing of the shaft through creep closure and recompaction of crushed backfill. Appropriate methods are demonstrated to calculate cumulative distribution functions of the closure based on laboratory determined random variable uncertainty in salt creep properties.

  18. Total knee arthroplasty closure with barbed sutures.

    PubMed

    Eickmann, Tom; Quane, Erika

    2010-09-01

    Bidirectional barbed sutures, which do not require the tying of knots, have the potential to reduce closure times of total knee arthroplasty (TKA) wounds without adverse effect to wound security, cosmesis, or infection risk. In this retrospective study, data were reviewed from TKAs performed between January 2007 and September 2008. For 88 of these procedures, conventional absorbable sutures were used for interrupted closure of the retinacular and subcutaneous layers and for running closure of the subcuticular layer. For 90 procedures, bidirectional barbed absorbable sutures were used for running closure of the retinacular and subcutaneous layers. Surgeries performed with barbed sutures were significantly faster than those performed with conventional sutures (mean times of 74.3 minutes and 85.8 minutes, respectively, p < 0.001) with no detrimental clinical effects.

  19. TECHNICAL ASPECTS OF UNDERGROUND STORAGE TANK CLOSURE

    EPA Science Inventory

    The overall objective of the study was to develop a deeper understanding of UST residuals at closure: their quantities, origins, physical/chemical properties, ease of removal by various cleaning methods, and their environmental mobility and persistence. The investigation covered ...

  20. Entropy production and collisionless fluid closure

    NASA Astrophysics Data System (ADS)

    Sarazin, Y.; Dif-Pradalier, G.; Zarzoso, D.; Garbet, X.; Ghendrih, Ph; Grandgirard, V.

    2009-11-01

    A novel method is proposed to construct collisionless fluid closures accounting for some kinetic properties. The idea consists in optimizing the agreement between the fluid and kinetic quasi-linear entropy production rates, so as to constrain the closure coefficients. This procedure is applied to the slab branch of the ion temperature gradient driven instability. Focusing on the kinetic regime characterized by slow waves, the closure proposed by Hammett and Perkins (Hammett and Perkins 1990 Phys. Rev. Lett. 64 3019) naturally emerges from the systematic identification of the kinetic and fluid entropy production rates. This closure is revealed to be extremely powerful well beyond the kinetic regime. Besides, it reconciles the fluid and kinetic linear stability diagrams in the two-dimensional space of the density and temperature gradient lengths. Such a method is systematic and generic. As such, it is applicable to other models and classes of instabilities.

  1. Occupancy estimation and the closure assumption

    USGS Publications Warehouse

    Rota, Christopher T.; Fletcher, Robert J.; Dorazio, Robert M.; Betts, Matthew G.

    2009-01-01

    1. Recent advances in occupancy estimation that adjust for imperfect detection have provided substantial improvements over traditional approaches and are receiving considerable use in applied ecology. To estimate and adjust for detectability, occupancy modelling requires multiple surveys at a site and requires the assumption of 'closure' between surveys, i.e. no changes in occupancy between surveys. Violations of this assumption could bias parameter estimates; however, little work has assessed model sensitivity to violations of this assumption or how commonly such violations occur in nature. 2. We apply a modelling procedure that can test for closure to two avian point-count data sets in Montana and New Hampshire, USA, that exemplify time-scales at which closure is often assumed. These data sets illustrate different sampling designs that allow testing for closure but are currently rarely employed in field investigations. Using a simulation study, we then evaluate the sensitivity of parameter estimates to changes in site occupancy and evaluate a power analysis developed for sampling designs that is aimed at limiting the likelihood of closure. 3. Application of our approach to point-count data indicates that habitats may frequently be open to changes in site occupancy at time-scales typical of many occupancy investigations, with 71% and 100% of species investigated in Montana and New Hampshire respectively, showing violation of closure across time periods of 3 weeks and 8 days respectively. 4. Simulations suggest that models assuming closure are sensitive to changes in occupancy. Power analyses further suggest that the modelling procedure we apply can effectively test for closure. 5. Synthesis and applications. Our demonstration that sites may be open to changes in site occupancy over time-scales typical of many occupancy investigations, combined with the sensitivity of models to violations of the closure assumption, highlights the importance of properly addressing

  2. 40 CFR 258.61 - Post-closure care requirements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 25 2014-07-01 2014-07-01 false Post-closure care requirements. 258.61 Section 258.61 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES CRITERIA FOR MUNICIPAL SOLID WASTE LANDFILLS Closure and Post-Closure Care § 258.61 Post-closure...

  3. 40 CFR 258.61 - Post-closure care requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 25 2011-07-01 2011-07-01 false Post-closure care requirements. 258.61 Section 258.61 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES CRITERIA FOR MUNICIPAL SOLID WASTE LANDFILLS Closure and Post-Closure Care § 258.61 Post-closure...

  4. 40 CFR 258.61 - Post-closure care requirements.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 26 2012-07-01 2011-07-01 true Post-closure care requirements. 258.61 Section 258.61 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES CRITERIA FOR MUNICIPAL SOLID WASTE LANDFILLS Closure and Post-Closure Care § 258.61 Post-closure...

  5. 40 CFR 264.119 - Post-closure notices.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 27 2013-07-01 2013-07-01 false Post-closure notices. 264.119 Section... and Post-Closure § 264.119 Post-closure notices. (a) No later than 60 days after certification of... the first hazardous waste disposal unit and within 60 days of certification of closure of the last...

  6. 40 CFR 267.117 - How do I certify closure?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 26 2010-07-01 2010-07-01 false How do I certify closure? 267.117 Section 267.117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES... PERMIT Closure § 267.117 How do I certify closure? Within 60 days of the completion of final closure...

  7. 40 CFR 267.117 - How do I certify closure?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 27 2011-07-01 2011-07-01 false How do I certify closure? 267.117 Section 267.117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES... PERMIT Closure § 267.117 How do I certify closure? Within 60 days of the completion of final closure...

  8. 40 CFR 267.117 - How do I certify closure?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 28 2012-07-01 2012-07-01 false How do I certify closure? 267.117 Section 267.117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES... PERMIT Closure § 267.117 How do I certify closure? Within 60 days of the completion of final closure...

  9. Why does acute primary angle closure happen? Potential risk factors for acute primary angle closure.

    PubMed

    Zhang, Xiulan; Liu, Yaoming; Wang, Wei; Chen, Shida; Li, Fei; Huang, Wenbin; Aung, Tin; Wang, Ningli

    Acute primary angle closure is an ocular emergency and requires immediate management to avoid blindness. Narrow anterior chamber angle, advanced age, female gender, and Asian ethnic background are considered risk factors for acute primary angle closure. The predictive power of these factors is, however, relatively poor, and many questions remain unanswered because acute primary angle closure eventually develops in only a relatively small proportion of anatomically predisposed eyes. We summarize the potential roles of various factors in the pathogenesis of acute primary angle closure. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Primary closure for postoperative mediastinitis in children.

    PubMed

    Ohye, Richard G; Maniker, Robert B; Graves, Holly L; Devaney, Eric J; Bove, Edward L

    2004-09-01

    Mediastinitis affects approximately 1% of children undergoing median sternotomy. Conventional therapy involves debridement followed by open wound care with delayed closure, days to weeks of closed suction or antimicrobial irrigation, and vacuum-assisted closure or muscle flap closure. We hypothesized that primary closure without prolonged suction or irrigation is an effective, less traumatic treatment for mediastinitis in children. From January 1986 to July 2002, 6705 procedures involving median sternotomy were performed at the C. S. Mott Children's Hospital, resulting in 57 cases of mediastinitis (0.85%). Cases were divided into 2 groups, with 42 cases treated with primary closure and 15 cases treated with delayed or muscle flap closure. The 42 cases of primary closure comprised the primary study group of this institutional review board-approved, retrospective analysis. Patient demographics, surgical variables, mediastinitis-related parameters, and outcomes were evaluated. One patient had recurrent mediastinitis for an overall infection eradication rate of 97% (40/41). Three patients (7%) required re-exploration for suspected ongoing infection. Of these re-explorations, 1 patient had evidence of continued mediastinitis. The remaining 2 patients with sepsis of unclear cause had no clinical or culture evidence of recurrent infection. One of these patients ultimately died of sepsis without active mediastinitis for a hospital survival of 97% (41/42). No significant differences could be detected between the treatment successes and failures in this small cohort of patients. Simple primary closure is an effective means to treat selected cases of postoperative mediastinitis in children. The results compare favorably with other more lengthy or debilitating treatments.

  11. Fatigue Growth and Closure of Short Cracks

    DTIC Science & Technology

    1989-06-03

    TESTS 87 4.5 SHORT CRACK FATIGUE TESTS IN NOTCHED SPECIMENS 101 5. DISCUSSION 5.1 DURABILITY ANALYSIS - EQUIVALENT INITIAL FLAW SIZE 232 5.2 SHORT... equivalent initial flaw size approach, (2) effects of plasticity, (3) crack closure response of long cracks and (4) crack closure response of short...cracks. 5.1 EQUIVALENT INITIAL FLAW SIZE - DURABILITY ANALYSIS Aerospace structures were Initially designed on a safe-life approach. The underlying

  12. Creating eye closure in patients with facial nerve paralysis using an implantable solenoid actuator.

    PubMed

    Hasmat, Shaheen; Lovell, Nigel H; Eviston, Timothy; Ekmejian, Rafael; Suaning, Gregg J; Clark, Jonathan

    2015-08-01

    This paper proposes the use of an implantable solenoid actuator to create a more natural eyelid closure over current lid loading therapies in patients with facial nerve paralysis (FNP). The actuator works by moving a magnet when a solenoid is activated. This is used to tension a sling applied to the upper eyelid which closes the eye. The sling design has been described elsewhere and creating eye closure using it requires a force of 627 (± 128) mN over a movement of approximately 6 mm. The actuator described here was able to successfully achieve these parameters and repeatedly perform eyelid closure in a cadaveric rabbit model. Device limitations and future improvements have also been identified and discussed.

  13. The Determinants of Care Home Closure

    PubMed Central

    Allan, Stephen; Forder, Julien

    2015-01-01

    This study investigates the causes of full closure of care homes in the English care home/nursing home market. We develop theoretical arguments about two causes for closure that are triggered by errors or external shocks: poor economic sustainability and regulatory action. Homes aiming to operate with lower quality in the market are argued for a number of reasons to be more susceptible to errors/shocks in setting quality, especially negative errors, leading to an empirical hypothesis that observed quality should negatively affect closure chance. In addition, given quality, homes facing relatively high levels of local competition should also have an increased chance of closure. We use a panel of care homes from 2008 and 2010 to examine factors affecting their closure status in subsequent years. We allow for the potential endogeneity of home quality and use multiple imputation to replace missing data. Results suggest that homes with comparatively higher quality and/or lower levels of competition have less chance of closure than other homes. We discuss that the results provide some support for the policy of regulators providing quality information to potential purchasers in the market. © 2015 The Authors. Health Economics published by John Wiley & Sons Ltd. PMID:25760588

  14. Ultrasonic characterization of fatigue crack closure

    SciTech Connect

    Thompson, R.B.; Buck, O.; Rehbein, D.K.

    1991-01-01

    The characterization of fatigue crack closure is an important objective because of its influence on fatigue crack propagation, particularly under conditions of variable amplitude loading. This paper describes a nontraditional technique for characterizing closure, in which ultrasonic scattering measurements are used to obtain estimates of the number density and size of asperities bridging the crack faces, with subsequent estimates of the crack tip shielding being based on those geometrical parameters. The paper first reviews the experimental configuration and the basic elasto-dynamic theory underlying the technique. It then presents recent results obtained in studies of the influence of block overloads and load shedding on the growth of fatigue cracks in aluminum alloys. In both cases, the change in the closure state after the overload can be unambiguously seen even in the raw data. Moreover, data analysis suggests that it may be possible to predict when the crack will reinitiate based on more subtle changes in the ultrasonically inferred closure state. In the case of load shedding, a massive closure region is observed, whose characteristics appear consistent with the notion that threshold phenomena can be explained in terms of crack closure. 20 refs., 10 figs.

  15. 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.

  16. 77 FR 75186 - Notice of Closure, Target Shooting Public Safety Closure on the Lake Mountains in Utah County, UT

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-19

    ... Bureau of Land Management Notice of Closure, Target Shooting Public Safety Closure on the Lake Mountains... shooting to protect public safety. This closure does not restrict other public activities or access to the Lake Mountains area. DATES: This target shooting closure within the described area will remain in...

  17. NPAR- products, applications and closure

    SciTech Connect

    Vora, J.P.

    1995-04-01

    Almost a decade ago the Office of Nuclear Regulatory Research (RES) developed and implemented a comprehensive research program (NUREG-1144) widely known as NPAR or Nuclear Plant Aging Research. The NPAR program is a structured research program specifically oriented to understanding significant age-related degradation mechanisms and their long term effects on properties and performance of important components and systems and ways to mitigate detrimental effects of aging. It provided a road map and a phased approach to research that is applicable to any structure, system, or component of interest. This hardware-oriented engineering research program led the industry worldwide and communicated a need to understand and manage age-related degradation effects in selected but important structures and components. At the conclusion (1995) of the NPAR program, 22 electrical and mechanical components, 13 safety-related systems, and 10 special topics will have been studied and results summarized in 160 technical reports. This reference library of information listed and summarized in NUREG-1377, Rev. No. 4 provides a foundation upon which individual programs can be built for the specific needs of a utility, a regulator, or equipment manufacturers. During the life of the NPAR program, it has provided technical bases and support for license renewal, codes and standards, resolution of generic safety issues, information notices, regulatory guides and the standard Review Plan, as well as the Office of Nuclear Reactor Regulation and The NRC Regions. All ongoing NPAR activities will either be completed or terminated by the end of 1995. No new initiative will be undertaken. This paper summarizes NPAR products and accomplishments, application of the research results, and its status and closure.

  18. Accelerating cleanup: Paths to closure

    SciTech Connect

    1998-06-01

    This report describes the status of Environmental Management`s (EM`s) cleanup program and a direction forward to complete achievement of the 2006 vision. Achieving the 2006 vision results in significant benefits related to accomplishing EM program objectives. As DOE sites accelerate cleanup activities, risks to public health, the environment, and worker safety and health are all reduced. Finding more efficient ways to conduct work can result in making compliance with applicable environmental requirements easier to achieve. Finally, as cleanup activities at sites are completed, the EM program can focus attention and resources on the small number of sites with more complex cleanup challenges. Chapter 1 describes the process by which this report has been developed and what it hopes to accomplish, its relationship to the EM decision-making process, and a general background of the EM mission and program. Chapter 2 describes how the site-by-site projections were constructed, and summarizes, for each of DOE`s 11 Operations/Field Offices, the projected costs and schedules for completing the cleanup mission. Chapter 3 presents summaries of the detailed cleanup projections from three of the 11 Operations/Field Offices: Rocky Flats (Colorado), Richland (Washington), and Savannah River (South Carolina). The remaining eight Operations/Field Office summaries are in Appendix E. Chapter 4 reviews the cost drivers, budgetary constraints, and performance enhancements underlying the detailed analysis of the 353 projects that comprise EM`s accelerated cleanup and closure effort. Chapter 5 describes a management system to support the EM program. Chapter 6 provides responses to the general comments received on the February draft of this document.

  19. Observation of a periodic array of flux-closure quadrants in strained ferroelectric PbTiO3 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 PbTiO3 films, mediated by tensile strain on a GdScO3 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 PbTiO3 film thickness. In the vicinity of the core, the strain is sufficient to rupture the lattice, with strain gradients up tomore » 109 per meter. We found engineering strain at the nanoscale may facilitate the development of nanoscale ferroelectric devices.« less

  20. Monte Carlo simulation for thermal assisted reversal process of micro-magnetic torus ring with bistable closure domain structure

    NASA Astrophysics Data System (ADS)

    Terashima, Kenichi; Suzuki, Kenji; Yamaguchi, Katsuhiko

    2016-04-01

    Monte Carlo simulations were performed for temperature dependences of closure domain parameter for a magnetic micro-torus ring cluster under magnetic field on limited temperature regions. Simulation results show that magnetic field on tiny limited temperature region can reverse magnetic closure domain structures when the magnetic field is applied at a threshold temperature corresponding to intensity of applied magnetic field. This is one of thermally assisted switching phenomena through a self-organization process. The results show the way to find non-wasteful pairs between intensity of magnetic field and temperature region for reversing closure domain structure by temperature dependence of the fluctuation of closure domain parameter. Monte Carlo method for this simulation is very valuable to optimize the design of thermally assisted switching devices.

  1. Primary angle closure glaucoma: What we know and what we don't know.

    PubMed

    Sun, Xinghuai; Dai, Yi; Chen, Yuhong; Yu, Dao-Yi; Cringle, Stephen J; Chen, Junyi; Kong, Xiangmei; Wang, Xiaolei; Jiang, Chunhui

    2017-03-01

    Primary angle-closure glaucoma (PACG) is a common cause of blindness. Angle closure is a fundamental pathologic process in PAGC. With the development of imaging devices for the anterior segment of the eye, a better understanding of the pathogenesis of angle closure has been reached. Aside from pupillary block and plateau iris, multiple-mechanisms are more common contributors for closure of the angle such as choroidal thickness and uveal expansion, which may be responsible for the presenting features of PACG. Recent Genome Wide Association Studies identified several new PACG loci and genes, which may shed light on the molecular mechanisms of PACG. The current classification systems of PACG remain controversial. Focusing the anterior chamber angle is a principal management strategy for PACG. Treatments to open the angle or halt the angle closure process such as laser peripheral iridotomy and/or iridoplasty, as well as cataract extraction, are proving their effectiveness. PACG may be preventable in the early stages if future research can identify which kind of angles and/or persons are more likely to benefit from prophylactic treatment. New treatment strategies like adjusting the psychological status and balancing the sympathetic-parasympathetic nerve activity, and innovative medicines are needed to improve the prognosis of PACG. In this review, we intend to describe current understanding and unknown aspects of PACG, and to share the clinical experience and viewpoints of the authors.

  2. Skin stretching for primary closure of acute burn wounds.

    PubMed

    Verhaegen, Pauline D H M; Bloemen, Monica C T; van der Wal, Martijn B A; Vloemans, Adrianus F P M; Tempelman, Fenike R H; Beerthuizen, Gerard I J M; van Zuijlen, Paul P M

    2014-12-01

    In burn care, a well-acknowledged problem is the suboptimal scar outcome from skin grafted burn wounds. With the aim of improving this, we focused on a new technique: excision of the burn wound followed by primary closure, thereby using a skin-stretching device to stretch the adjacent healthy skin. The short- and long-term effect of Skin Stretch was compared to split skin grafting (SSG) in a randomized controlled trial. Patients with burn wounds were randomized for SSG or primary wound closure using Skin Stretch. Follow-up was performed at 3 and 12 months postoperatively. The scar surface area was calculated and the scar quality was assessed, using subjective and objective measurement methods. No significant differences between the SSG and the Skin Stretch group were found for scar surface area. In the Skin Stretch group, a significant reduction of the surface area from 65.4cm(2) (13.6-129.1) to 13.4cm(2) (3.0-36.6) was found at 3 months (p=0.028) and at 12 months postoperatively (65.4cm(2) (13.6-129.1) to 33.0cm(2) (8.9-63.7), p=0.046, Wilcoxon signed ranks test). Skin Stretch for primary closure of acute burn wounds is a suitable technique and can be considered for specific circumscript full-thickness burn wounds. However, future research should be performed to provide additional scientific evidence. Copyright © 2014 Elsevier Ltd and ISBI. All rights reserved.

  3. Characterization of microchannels created by metal microneedles: formation and closure.

    PubMed

    Kalluri, Haripriya; Kolli, Chandra Sekhar; Banga, Ajay K

    2011-09-01

    Transdermal delivery of therapeutic agents for cosmetic therapy is limited to small and lipophilic molecules by the stratum corneum barrier. Microneedle technology overcomes this barrier and offers a minimally invasive and painless route of administration. DermaRoller(®), a commercially available handheld device, has metal microneedles embedded on its surface which offers a means of microporation. We have characterized the microneedles and the microchannels created by these microneedles in a hairless rat model, using models with 370 and 770 μm long microneedles. Scanning electron microscopy was employed to study the geometry and dimensions of the metal microneedles. Dye binding studies, histological sectioning, and confocal microscopy were performed to characterize the created microchannels. Recovery of skin barrier function after poration was studied via transepidermal water loss (TEWL) measurements, and direct observation of the pore closure process was investigated via calcein imaging. Characterization studies indicate that 770 μm long metal microneedles with an average base width of 140 μm and a sharp tip with a radius of 4 μm effectively created microchannels in the skin with an average depth of 152.5 ± 9.6 μm and a surface diameter of 70.7 ± 9.9 μm. TEWL measurements indicated that skin regains it barrier function around 4 to 5 h after poration, for both 370 and 770 μm microneedles. However, direct observation of pore closure, by calcein imaging, indicated that pores closed by 12 h for 370 μm microneedles and by 18 h for 770 μm microneedles. Pore closure can be further delayed significantly under occluded conditions.

  4. Does left atrial appendage closure improve the success of pulmonary vein isolation? Results of a randomized clinical trial.

    PubMed

    Romanov, Alexander; Pokushalov, Evgeny; Artemenko, Sergey; Yakubov, Akmal; Stenin, Ilya; Kretov, Evgeny; Krestianinov, Oleg; Grazhdankin, Igor; Risteski, Dejan; Karaskov, Alexander; Steinberg, Jonathan S

    2015-10-01

    The combination of left atrial appendage (LAA) occlusion with pulmonary vein isolation (PVI) potentially represents a comprehensive treatment for atrial fibrillation (AF), controlling symptoms while at the same time reducing the risk of stroke and the need for chronic anticoagulation. The aim of this randomized clinical trial was to assess the impact of LAA closure added to PVI in patients with high-risk AF. Patients with a history of symptomatic paroxysmal or persistent AF refractory to ≥ 2 antiarrhythmic drugs, CHA2DS2-VASc score ≥ 2, and HAS-BLED score ≥ 3 were randomized to PVI-only (n = 44) or PVI with LAA closure (n = 45). Six patients in PVI + LAA closure group crossed over to PVI-only group due to failure of LAA closure device implantation. On-treatment comparisons at the 24 month follow-up revealed that 33 (66%) of the 50 PVI group and 23 (59%) of the 39 PVI with LAA closure group were AF-free on no antiarrhythmic drugs (p = 0.34). The PVI + LAA closure treatment was significantly associated with a higher AF burden during the blanking period: 9.7 ± 10.8 vs 4.2 ± 4.1% (p = 0.004). At the end follow-up, there were no serious complications and no strokes or thromboembolic events in either group. The combination of LAA closure device implantation with PVI was safe but was not observed to influence the success of PVI in patients with symptomatic refractory AF. Early AF after ablation, however, is increased by LAA closure. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01695824.

  5. An eddy closure for potential vorticity

    SciTech Connect

    Ringler, Todd D

    2009-01-01

    The Gent-McWilliams (GM) parameterization is extended to include a direct influence in the momentum equation. The extension is carried out in two stages; an analysis of the inviscid system is followed by an analysis of the viscous system. In the inviscid analysis the momentum equation is modified such that potential vorticity is conserved along particle trajectories following a transport velocity that includes the Bolus velocity in a manner exactly analogous to the continuity and tracer equations. In addition (and in contrast to traditional GM closures), the new formulation of the inviscid momentum equation results in a conservative exchange between potential and kinetic forms of energy. The inviscid form of the eddy closure conserves total energy to within an error proportional to the time derivative of the Bolus velocity. The hypothesis that the viscous term in the momentum equation should give rise to potential vorticity being diffused along isopycnals in a manner analogous to other tracers is examined in detail. While the form of the momentum closure that follows from a strict adherence to this hypothesis is not immediately interpretable within the constructs of traditional momentum closures, three approximations to this hypothesis results in a form of dissipation that is consistent with traditional Laplacian diffusion. The first two approximations are that relative vorticity, not potential vorticity, is diffused along isopyncals and that the flow is in approximate geostrophic balance. An additional approximation to the Jacobian term is required when the dissipation coefficient varies in space. More importantly, the critique of this hypothesis results in the conclusion that the viscosity parameter in the momentum equation should be identical to the tradition GM closure parameter {Kappa}. Overall, we deem the viscous form of the eddy closure for potential vorticity as a viable closure for use in ocean circulation models.

  6. Y-12 centralized sanitary landfill II closure/post-closure plan

    SciTech Connect

    Not Available

    1992-02-24

    The following text details closure and post-closure activities to be conducted at the Y-12 Centralized Sanitary Landfill II, a landfill for nonhazardous and nonradioactive wastes. This report describes containment, drainage, groundwater monitoring, methane gas monitoring costs, and quality assurance.

  7. Y-12 centralized sanitary landfill II closure/post-closure plan. Revision 1

    SciTech Connect

    Not Available

    1992-02-24

    The following text details closure and post-closure activities to be conducted at the Y-12 Centralized Sanitary Landfill II, a landfill for nonhazardous and nonradioactive wastes. This report describes containment, drainage, groundwater monitoring, methane gas monitoring costs, and quality assurance.

  8. 40 CFR 265.1102 - Closure and post-closure care.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    .... (b) If, after removing or decontaminating all residues and making all reasonable efforts to effect... with the closure and post-closure requirements that apply to landfills (§ 265.310). In addition, for... then considered to be a landfill, and the owner or operator must meet all of the requirements...

  9. 40 CFR 264.1102 - Closure and post-closure care.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... removing or decontaminating all residues and making all reasonable efforts to effect removal or... closure and post-closure requirements that apply to landfills (§ 264.310). In addition, for the purposes... considered to be a landfill, and the owner or operator must meet all of the requirements for...

  10. 40 CFR 264.1102 - Closure and post-closure care.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... removing or decontaminating all residues and making all reasonable efforts to effect removal or... closure and post-closure requirements that apply to landfills (§ 264.310). In addition, for the purposes... considered to be a landfill, and the owner or operator must meet all of the requirements for...

  11. 40 CFR 265.1102 - Closure and post-closure care.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    .... (b) If, after removing or decontaminating all residues and making all reasonable efforts to effect... with the closure and post-closure requirements that apply to landfills (§ 265.310). In addition, for... then considered to be a landfill, and the owner or operator must meet all of the requirements...

  12. 40 CFR 265.1102 - Closure and post-closure care.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    .... (b) If, after removing or decontaminating all residues and making all reasonable efforts to effect... with the closure and post-closure requirements that apply to landfills (§ 265.310). In addition, for... then considered to be a landfill, and the owner or operator must meet all of the requirements...

  13. 40 CFR 264.1102 - Closure and post-closure care.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... removing or decontaminating all residues and making all reasonable efforts to effect removal or... closure and post-closure requirements that apply to landfills (§ 264.310). In addition, for the purposes... considered to be a landfill, and the owner or operator must meet all of the requirements for...

  14. 40 CFR 264.1102 - Closure and post-closure care.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... removing or decontaminating all residues and making all reasonable efforts to effect removal or... closure and post-closure requirements that apply to landfills (§ 264.310). In addition, for the purposes... considered to be a landfill, and the owner or operator must meet all of the requirements for...

  15. 40 CFR 265.1102 - Closure and post-closure care.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    .... (b) If, after removing or decontaminating all residues and making all reasonable efforts to effect... with the closure and post-closure requirements that apply to landfills (§ 265.310). In addition, for... then considered to be a landfill, and the owner or operator must meet all of the requirements...

  16. Percutaneous retrograde transfemoral closure of mitral paravalvular leak in 3 patients without construction of an arteriovenous wire loop.

    PubMed

    Kilic, Teoman; Sahin, Tayfun; Ural, Ertan

    2014-04-01

    Percutaneous closure of paravalvular leaks has emerged as an alternative to repeated surgeries. Different percutaneous techniques and various devices have been used, off-label, for paravalvular leak closure. For mitral leaks, antegrade transseptal, retrograde transfemoral, and retrograde transapical techniques have been developed. In the antegrade transseptal approach, an arteriovenous guidewire loop is often created to advance the delivery sheath. In retrograde transfemoral closure, the wire in the left atrium is usually snared after transseptal puncture, to pull it from the femoral vein. The delivery sheath and closure device will subsequently be deployed from the left atrium. Each of these procedures takes time, is costly, and increases the risk of complications. We present the cases of 3 patients in whom we closed mitral paravalvular leaks by means of a retrograde transfemoral approach, with use of an Amplatzer™ Duct Occluder II device and without the construction of an arteriovenous wire loop. We think that this approach can be very useful in a specific group of patients-reducing costs, fluoroscopy times, and complications related to transseptal puncture and construction of an arteriovenous wire loop. In our institution, this reported technique is routinely used for mitral paravalvular leak closure.

  17. Percutaneous Retrograde Transfemoral Closure of Mitral Paravalvular Leak in 3 Patients without Construction of an Arteriovenous Wire Loop

    PubMed Central

    Kilic, Teoman; Sahin, Tayfun; Ural, Ertan

    2014-01-01

    Percutaneous closure of paravalvular leaks has emerged as an alternative to repeated surgeries. Different percutaneous techniques and various devices have been used, off-label, for paravalvular leak closure. For mitral leaks, antegrade transseptal, retrograde transfemoral, and retrograde transapical techniques have been developed. In the antegrade transseptal approach, an arteriovenous guidewire loop is often created to advance the delivery sheath. In retrograde transfemoral closure, the wire in the left atrium is usually snared after transseptal puncture, to pull it from the femoral vein. The delivery sheath and closure device will subsequently be deployed from the left atrium. Each of these procedures takes time, is costly, and increases the risk of complications. We present the cases of 3 patients in whom we closed mitral paravalvular leaks by means of a retrograde transfemoral approach, with use of an Amplatzer™ Duct Occluder II device and without the construction of an arteriovenous wire loop. We think that this approach can be very useful in a specific group of patients—reducing costs, fluoroscopy times, and complications related to transseptal puncture and construction of an arteriovenous wire loop. In our institution, this reported technique is routinely used for mitral paravalvular leak closure. PMID:24808777

  18. Lung perfusion studies after transcatheter closure of persistent ductus arteriosus with the Amplatzer duct occluder.

    PubMed

    Polat, Tugcin Bora; Celebi, Ahmet; Hacımahmutoglu, Sevim; Akdeniz, Celal; Erdem, Abdullah; Fırat, Fatih

    2010-09-01

    Reduced left lung perfusion has been described after transcatheter closure of the patent ductus arteriosus (PDA) with several prostheses. Although the Amplatzer ductal occluder (ADO) device is currently the most widely used occluder for closure of large-sized PDAs, the potential consequences of flow distribution to the lungs of this device have not been completely clarified. We evaluated lung perfusion following occlusion of PDA with the ADO device. Forty-seven patients underwent successful transcatheter PDA occlusion using the ADO device were included in this study. Lung perfusion scans were performed 6 months after the procedure. Decreased perfusion to the left lung (defined as < 40% of total lung flow) was observed in 17 patients (36%), 5 of whom were low-weight symptomatic infants. Ductal ampulla length was significantly shorter and minimal ductal diameter to ampulla diameter ratio was significantly higher in patients with decreased left lung perfusion and correlated well with left lung perfusion values (r = 0.516 and r = -0.501, respectively). A cut-off value of ≤ 5.8 mm for the ductal ampulla length and ≥ 1.9 for ampulla diameter to ampulla length ratio showed high sensitivity and specificity for reduced lung perfusion. The incidence of abnormal left lung perfusion is high 6 months after transcatheter closure of PDA with the ADO, more likely in the low weight symptomatic infants and in patients with a short duct or a relatively shallow duct having abrupt narrowing of a large ampulla.

  19. 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.

  20. [Closure of the patent ductus arteriosus by means of cardiac catheterization].

    PubMed

    Szatmári, A; Németh, J; Környei, L; Palik, I; Hartyánszky, I; Lozsádi, K

    1998-05-24

    Authors report their results with transcatheter closure of patent arterial duct during a period of 1 year. Thirty patients underwent the procedure at the mean age of 5.22 yrs (range 5 mos-22.3 yrs) and mean bodyweight of 19.1 kg (range 5.8-73 kg). There were 9 males and 21 females. The diagnosis of the patent arterial duct was established by physical examination and noninvasive techniques. The procedures were attempted in all patients above 5 kg bodyweight with patent arterial duct and normal pulmonary artery pressure, irrespective of the shunt-size. All procedures were performed under general anesthesia in one session with the diagnostic cardiac catheterisation. Transcatheter closure was successful in 29 patients. In one patient the device embolized into the left pulmonary artery, snaring was unsuccessful, surgical closure of the patent duct and removal of the device took place uneventfully. Control aortography 15 minutes after the coil placement showed insignificant residual shunt through the patent duct in 8 patients (27%), while echocardiography at 1 month proved complete closure in all. The patients were followed by noninvasive methods. No mortality was observed. Authors emphasize the low risk and cost-effectiveness of the procedure. They stress the importance of the patients selection. Authors applied the technique for the first time and introduced it to the regular patient-care practice in Hungary.

  1. 40 CFR 63.943 - Standards-Surface impoundment vented to control device.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... the cover not vented to the control device shall be equipped with a closure device. If the pressure in the vapor headspace underneath the cover is less than atmospheric pressure when the control device is... headspace underneath the cover is equal to or greater than atmospheric pressure when the control device...

  2. A nonlocal fluid closure for antiparallel reconnection

    NASA Astrophysics Data System (ADS)

    Ng, J.; Hakim, A.; Bhattacharjee, A.

    2016-12-01

    The integration of kinetic effects in fluid models is an important problem in global simulations of the Earth's magnetosphere and space weather modelling. In particular, it has been shown that ion kinetics play an important role in the dynamics of large reconnecting systems, and that fluid models can account of some of these effects[1,2] . Here we introduce a new fluid model and closure for collisionless magnetic reconnection and more general applications. Taking moments of the kinetic equation, we evolve the full pressure tensor for electrons and ions, which includes the off diagonal terms necessary for reconnection. Kinetic effects are recovered by using a nonlocal heat flux closure, which approximates linear Landau damping in the fluid framework [3]. Using the island coalescence problem as a test, we show how the nonlocal ion closure improves on the typical collisional closures used for ten-moment models and circumvents the need for a colllisional free parameter. Finally, we extend the closure to study guide-field reconnection and discuss the implementation of a twenty-moment model.[1] A. Stanier et al. Phys Rev Lett (2015)[2] J. Ng et al. Phys Plasmas (2015)[3] G. Hammett et al. Phys Rev Lett (1990)

  3. Space Station evolution study oxygen loop closure

    NASA Technical Reports Server (NTRS)

    Wood, M. G.; Delong, D.

    1993-01-01

    In the current Space Station Freedom (SSF) Permanently Manned Configuration (PMC), physical scars for closing the oxygen loop by the addition of oxygen generation and carbon dioxide reduction hardware are not included. During station restructuring, the capability for oxygen loop closure was deferred to the B-modules. As such, the ability to close the oxygen loop in the U.S. Laboratory module (LAB A) and the Habitation A module (HAB A) is contingent on the presence of the B modules. To base oxygen loop closure of SSF on the funding of the B-modules may not be desirable. Therefore, this study was requested to evaluate the necessary hooks and scars in the A-modules to facilitate closure of the oxygen loop at or subsequent to PMC. The study defines the scars for oxygen loop closure with impacts to cost, weight and volume and assesses the effects of byproduct venting. In addition, the recommended scenarios for closure with regard to topology and packaging are presented.

  4. Community perceptions of rural hospital closure.

    PubMed

    Muus, K J; Ludtke, R L; Gibbens, B

    1995-02-01

    Hospital closure, a devastating event in the life of small communities, can have long-lasting medical, economic, and psychological consequences. This study focuses on a 1991 closure that occurred in the rural North Dakota town of Beach that left local residents 40 and 61 miles away from the nearest hospitals. Two hundred residents of the hospital's former service area were selected via systematic random sampling to share their perceptions on the causes and effects of closing their local hospital. According to respondents, this hospital closure was caused by a number of influences, with the most commonly cited being under-utilization of services by local residents, exacting government rules and regulations, doleful economic climate, dwindling population, poor and unstable local physician care, and poor management of hospital matters. Findings further indicated that Beach area residents were most concerned with poor access to emergency medical care as a result of the closing. Area dwellers perceived that the hospital closure's aftermath would include the loss of local jobs, further declines in the local economy, the suffering of elderly and children, transportation problems, and out-migration of some area residents. These concerns, coupled with the notable decrease in hospital care access, motivated many area residents to think of solutions to these problems rather than to place blame on others for the closure.

  5. A nonlocal fluid closure for antiparallel reconnection

    NASA Astrophysics Data System (ADS)

    Ng, Jonathan; Hakim, A.; Bhattacharjee, A.

    2016-10-01

    The integration of kinetic effects in fluid models is an important problem in global simulations of the Earth's magnetosphere and space weather modelling. In particular, it has been shown that ion kinetics play an important role in the dynamics of large reconnecting systems, and that fluid models can account of some of these effects. Here we introduce a new fluid model and closure for collisionless magnetic reconnection and more general applications. Taking moments of the kinetic equation, we evolve the full pressure tensor for electrons and ions, which includes the off diagonal terms necessary for reconnection. Kinetic effects are recovered by using a nonlocal heat flux closure, which approximates linear Landau damping in the fluid framework. Using the island coalescence problem as a test, we show how the nonlocal ion closure improves on the typical collisional closures used for ten-moment models and circumvents the need for a colllisional free parameter. Finally, we extend the closure to study guide-field reconnection and discuss the implementation of a twenty-moment model. Supported by: NSF Grant No. AGS-1338944, DOE Contract DE-AC02-09CH11466.

  6. A unified physical model to explain Supercavity closure

    NASA Astrophysics Data System (ADS)

    Arndt, Roger; Karn, Ashish; Hong, Jiarong

    2014-11-01

    An insight into underlying physics behind supercavity closure is an important issue for the operation of underwater vehicles for a number of reasons viz. associated gas flow requirement with each closure regime, effect of cavity closure on the overall cavity behavior and collapse, differences between natural and ventilated supercavity closure etc. There have been several reports on supercavity closure since the 1950s and many empirical relationships governing different closure modes have been proposed by different authors. Yet, there is no universal agreement between results obtained at different experimental facilities. In some cases, contradictory observations have been made. In this talk, systematic investigations conducted into supercavity closure across a wide range of experimental conditions at the Saint Anthony Falls Laboratory (SAFL) are presented. A variety of closure mechanisms were observed including the ones widely reported in the literature, viz. twin vortex, re-entrant jet; new stable closure modes viz. quad vortex and interacting vortex and a host of transition closure modes. A hypothesis on the physical mechanism based on the pressure gradient across the cavity that determines the closure modes is proposed. Using this hypothesis and the control volume analysis at supercavity closure, we explain the observations from SAFL experiments as well as reconcile the observations reported by different researchers. The hypothesis explains the supercavity closure across different experimental facilities, at different blockage ratios and at different flow conditions. Thus, a unified understanding into supercavity closure from the viewpoint of fundamental physics is attempted. Supported by the Office Of Naval Research.

  7. Closure of a lateral baffle leak in a Fontan patient with an amplatzer PDA II AS plug.

    PubMed

    Muino, Laura; Suys, Bert; De Wolf, Daniël

    2012-10-01

    Cyanosis after Fontan surgery or surgery for total cavopulmonary connection (TCPC), due to different types of communications (fenestration, venovenous collaterals or fistula), is not uncommon. We present the case of an 8-year-old girl presenting with increasing cyanosis during exercise 4 years after an intracardiac TCPC with lateral tunnel. Angiography showed a fistulous trajectory originating at the superior vena cava towards the base of the right atrial appendage. Due to the difficult anatomy in our patient, closure with conventional devices was not possible. We finally used a new Amplatzer PDA II AS plug to successfully close the fistula. In conclusion, closure of lateral baffle leak and device choice in case of difficult anatomy can be cumbersome. The new PDA II AS type plug can offer an elegant alternative for successful closure of some fistula.

  8. Tulip deformity with Cera atrial septal defect devices: a report of 3 cases.

    PubMed

    Kohli, Vikas

    2015-02-01

    Device closure of secundum atrial septal defect (ASD) is the treatment of choice when anatomy is favourable. Amplatzer device has remained the gold standard for closure of ASD. Cobra deformity is a well-reported problem with devices. Recently, Tulip deformity has been reported in a single case. We report a series of cases where we noted Tulip deformity along with inability to retract the device in the sheath in Cera Lifetech devices. This resulted in prolongation of procedure, excessive fluoroscopic exposure and additional interventional procedures not usually anticipated in ASD device closure. We believe that the problem is due to the stiffness of the device resulting in its inability to be retracted into the sheath. We also report a unique way of retrieving the device.

  9. Transient phase behavior of an elastomeric biomaterial applied to abdominal laparotomy closure.

    PubMed

    Kaymakcalan, Omer E; Jin, Julia L; Sun, Zhexun; Ricapito, Nicole G; McCorry, Mary Clare; Morrison, Kerry A; Putnam, David; Spector, Jason A

    2017-08-01

    Secure closure of the fascial layers after entry into the peritoneal cavity is crucial to prevent incisional hernia, yet appropriate purchase of the tissue can be challenging due to the proximity of the underlying protuberant bowel which may become punctured by the surgical needle or strangulated by the suture itself. Devices currently employed to provide visceral protection during abdominal closure, such as the metal malleable retractor and Glassman Visceral Retainer, are unable to provide complete protection as they must be removed prior to complete closure. A puncture resistant, biocompatible, and degradable matrix that can be left in place without need for removal would facilitate rapid and safe abdominal closure. We describe a novel elastomer (CC-DHA) that undergoes a rapid but controlled solid-to-liquid phase transition through the application of a destabilized carbonate cross-linked network. The elastomer is comprised of a polycarbonate cross-linked network of dihydroxyacetone, glycerol ethoxylate, and tri(ethylene glycol). The ketone functionality of the dihydroxyacetone facilitates hydrolytic cleavage of the carbonate linkages resulting in a rapidly degrading barrier that can be left in situ to facilitate abdominal fascial closure. Using a murine laparotomy model we demonstrated rapid dissolution and metabolism of the elastomer without evidence of toxicity or intraabdominal scarring. Furthermore, needle puncture and mechanical properties demonstrated the material to be both compliant and sufficiently puncture resistant. These unique characteristics make the biomaterial extraordinarily useful as a physical barrier to prevent inadvertent bowel injury during fascial closure, with the potential for wider application across a variety of medical and surgical applications. Fascial closure after abdominal surgery requires delicate maneuvers to prevent incisional hernia while minimizing risk for inadvertent bowel injury. We describe a novel biocompatible and

  10. Biological constraints do not entail cognitive closure.

    PubMed

    Vlerick, Michael

    2014-12-01

    From the premise that our biology imposes cognitive constraints on our epistemic activities, a series of prominent authors--most notably Fodor, Chomsky and McGinn--have argued that we are cognitively closed to certain aspects and properties of the world. Cognitive constraints, they argue, entail cognitive closure. I argue that this is not the case. More precisely, I detect two unwarranted conflations at the core of arguments deriving closure from constraints. The first is a conflation of what I will refer to as 'representation' and 'object of representation'. The second confuses the cognitive scope of the assisted mind for that of the unassisted mind. Cognitive closure, I conclude, cannot be established from pointing out the (uncontroversial) existence of cognitive constraints. Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. Quantifying dorsal closure in three dimensions

    PubMed Central

    Lu, Heng; Sokolow, Adam; Kiehart, Daniel P.; Edwards, Glenn S.

    2016-01-01

    Dorsal closure is an essential stage of Drosophila embryogenesis and is a powerful model system for morphogenesis, wound healing, and tissue biomechanics. During closure, two flanks of lateral epidermis close an eye-shaped dorsal opening that is filled with amnioserosa. The two flanks of lateral epidermis are zipped together at each canthus (“corner” of the eye). Actomyosin-rich purse strings are localized at each of the two leading edges of lateral epidermis (“lids” of the eye). Here we report that each purse string indents the dorsal surface at each leading edge. The amnioserosa tissue bulges outward during the early-to-mid stages of closure to form a remarkably smooth, asymmetric dome indicative of an isotropic and uniform surface tension. Internal pressure of the embryo and tissue elastic properties help to shape the dorsal surface. PMID:27798232

  12. On Subsurface Fracture Opening and Closure

    NASA Astrophysics Data System (ADS)

    Wang, Y.

    2016-12-01

    Mechanistic understanding of fracture opening and closure in geologic media is of significant importance to nature resource extraction and waste management, such as geothermal energy extraction, oil/gas production, radioactive waste disposal, and carbon sequestration and storage). A dynamic model for subsurface fracture opening and closure has been formulated. The model explicitly accounts for the stress concentration around individual aperture channels and the stress-activated mineral dissolution and precipitation. A preliminary model analysis has demonstrated the importance of the stress-activated dissolution mechanism in the evolution of fracture aperture in a stressed geologic medium. The model provides a reasonable explanation for some key features of fracture opening and closure observed in laboratory experiments, including a spontaneous switch from a net permeability reduction to a net permeability increase with no changes in a limestone fracture experiment.

  13. Independently owned pharmacy closures in rural America.

    PubMed

    Boyle, Kaitlin; Ullrich, Fred; Mueller, Keith

    2012-07-01

    The closure of rural independently owned pharmacies, including pharmacies that are the sole source of access to local pharmacy services, from 2003 through 2011 coincides with the implementation of two major policies related to payment for prescription medications: (1) Medicare prescription drug discount cards were introduced on January 1, 2004; and (2) the Medicare prescription drug benefit (Part D) began on January 1, 2006. In this brief, we focus on rural pharmacy closure because of the potential threat such closures present to access to any local pharmacy services in a community. Services include providing medications from local stock without delay or travel, overseeing administration of medications to nursing homes and hospitals, and patient consultation.

  14. Hanford Patrol Academy demolition sites closure plan

    SciTech Connect

    Not Available

    1993-09-30

    The Hanford Site is owned by the U.S. Government and operated by the U.S. Department of Energy, Richland Operations Office. Westinghouse Hanford Company is a major contractor to the U.S. Department of Energy, Richland Operations Office and serves as co-operator of the Hanford Patrol Academy Demolition Sites, the unit addressed in this paper. This document consists of a Hanford Facility Dangerous Waste Part A Permit Application, Form 3 (Revision 4), and a closure plan for the site. An explanation of the Part A Form 3 submitted with this closure plan is provided at the beginning of the Part A section. This Hanford Patrol Academy Demolition Sites Closure Plan submittal contains information current as of December 15, 1994.

  15. Turbulence processes and simple closure schemes

    NASA Technical Reports Server (NTRS)

    Deissler, R. G.

    1977-01-01

    The problem of closure in turbulence in the case of two-point correlations resides in the existence of two unknowns E and W, the energy spectrum function and the transfer function, respectively, in the spectrum equation. In the case of weak turbulence, W is negligible. In case of higher correlations, closure can be effective by neglecting the inertia term in the highest order term used. Specifying a certain number of spectra at an initial time is also a way of getting around the closure problem. A simple case of turbulent shear flow is then considered, where two-point correlation equations are used and the velocity is broken into mean and fluctuating components. This yields a differential equation for the energy spectrum, the three terms of which are the energy spectrum, production term and dissipation term. They are plotted for a particular time. Similar analyses and comparisons with experiment are made for pipe and boundary layer flows.

  16. Spontaneous closure of traumatic macular holes.

    PubMed

    Faghihi, Hooshang; Ghassemi, Fariba; Falavarjani, Khalil Ghasemi; Saeedi Anari, Ghasem; Safizadeh, Mona; Shahraki, Kourosh

    2014-08-01

    To present a series of cases with spontaneous closure of traumatic macular hole. Case series. Six eyes of 6 patients with traumatic macular hole. The characteristics of eyes with macular hole secondary to blunt trauma in which the macular hole closed spontaneously without surgical manipulation were reviewed. Patient age range was 13 to 55 years. There were 4 full-thickness and 2 lamellar macular holes. Spontaneous closure occurred after 1 to 6 months of observation. Best corrected visual acuity improved in 5 eyes and remained unchanged in the other eye. Spontaneous closure of traumatic macular holes may occur within 6 months after initial presentation. Copyright © 2014 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

  17. Novafil. A dynamic suture for wound closure.

    PubMed Central

    Rodeheaver, G T; Nesbit, W S; Edlich, R F

    1986-01-01

    Abdominal wound dehiscence was quantitatively studied in a rat model. Polybutester suture is a new monofilament nonabsorbable suture that has unique stress-strain properties that are potentially beneficial for abdominal wound closure. The abdominal volume at the moment of wound dehiscence was correlated with the extensibility of the suture material used for closure. Interrupted sutures of polybutester cut through the tissues at a mean abdominal volume of 212 +/- 3 ml. This volume was significantly (p less than or equal to 0.005) greater than the mean volumes reached with nylon (197 +/- 3 ml) or polyglycolic acid (187 +/- 4 ml). Closure of abdomens with continuous polybutester suture resulted in a mean rupture volume of 218 +/- 3 ml, which was significantly (p less than or equal to 0.005) greater than that achieved with the same suture employed as simple interrupted sutures (212 +/- 4 ml). The influence of width of tissue bite, suture size, and needle configuration was also evaluated. PMID:3017248

  18. APPARATUS AND METHOD FOR WELDING END CLOSURE TO CONTAINER

    DOEpatents

    Frantz, C.E.; Correy, T.B.

    1959-08-01

    A semi-automatic apparatus is described for welding a closure to the open end of a can containing a nuclear fuel slug. An arc is struck at the center of the closure and is shifted to a region near its periphery. Then the assembly of closure, can, and fuel slug is rotated so that the peripheral region of the closure is preheated. Next the arc is shifted to the periphery itself of the closure, and the assembly is rotated so that the closure is welded to the can.

  19. Transcatheter closure of left ventricle to right atrial communication using cera duct occluder.

    PubMed

    Ganesan, Gnanavelu; Paul, G Justin; Mahadevan, Vaikom S

    Left ventricle-right atrial communication could be congenital (Gerbode defect) or acquired as a complication of surgery or infective endocarditis and leads to volume overloading of pulmonary circulation. Two types, direct and indirect types are known depending on the involvement of septal tricuspid leaflet. Transcatheter closure of this defect is feasible and appears an attractive alternative to surgical management. Various devices like Amplatzer duct occluder I, II, Muscular ventricular septal defect device etc. have been used to close this defect. We report two patients, a preteen boy with direct left ventricle-right atrial communication as post operative complication and an adult female with indirect communication who underwent transcatheter closure with Cera duct occluder (Lifetech Scientific (Shenzhen), China). Copyright © 2017. Published by Elsevier B.V.

  20. 2401-W Waste storage building closure plan

    SciTech Connect

    LUKE, S.M.

    1999-07-15

    This plan describes the performance standards met and closure activities conducted to achieve clean closure of the 2401-W Waste Storage Building (2401-W) (Figure I). In August 1998, after the last waste container was removed from 2401-W, the U.S. Department of Energy, Richland Operations Office (DOE-RL) notified Washington State Department of Ecology (Ecology) in writing that the 2401-W would no longer receive waste and would be closed as a Resource Conservation and Recovery Act (RCRA) of 1976 treatment, storage, and/or disposal (TSD) unit (98-EAP-475). Pursuant to this notification, closure activities were conducted, as described in this plan, in accordance with Washington Administrative Code (WAC) 173-303-610 and completed on February 9, 1999. Ecology witnessed the closure activities. Consistent with clean closure, no postclosure activities will be necessary. Because 2401-W is a portion of the Central Waste Complex (CWC), these closure activities become the basis for removing this building from the CWC TSD unit boundary. The 2401-W is a pre-engineered steel building with a sealed concrete floor and a 15.2-centimeter concrete curb around the perimeter of the floor. This building operated from April 1988 until August 1998 storing non-liquid containerized mixed waste. All waste storage occurred indoors. No potential existed for 2401-W operations to have impacted soil. A review of operating records and interviews with cognizant operations personnel indicated that no waste spills occurred in this building (Appendix A). After all waste containers were removed, a radiation survey of the 2401-W floor for radiological release of the building was performed December 17, 1998, which identified no radiological contamination (Appendix B).