Percutaneous closure of the left atrial appendage for prevention of thromboembolism in atrial fibrillation for patients with contraindication to or failure of oral anticoagulation: a single-center experience.

PubMed

Faustino, Ana; Paiva, Luís; Providência, Rui; Trigo, Joana; Botelho, Ana; Costa, Marco; Leitão-Marques, António

2013-06-01

In non-valvular atrial fibrillation 90% of thrombi originate in the left atrial appendage (LAA). Percutaneous LAA closure has been shown to be non-inferior to warfarin for prevention of thromboembolism. To evaluate the initial experience of a single center in percutaneous LAA closure in patients with high thromboembolic risk and in whom oral anticoagulation was impractical or contraindicated or had failed. Patients with non-valvular atrial fibrillation and CHADS2 score ≥2 in whom oral anticoagulation was impractical or contraindicated or had failed underwent percutaneous LAA closure according to the standard technique. After the procedure, dual antiplatelet therapy was maintained for one month, followed by single antiplatelet therapy indefinitely. Patients were followed by clinical assessment and transthoracic and transesophageal echocardiography. The procedure was performed in 22 of the 23 selected patients (95.7%), mean age 70±9 years, CHADS2 score 3.2±0.9 and CHA2DS2-VASC score 4.7±1.4. Intraprocedural device replacement was necessary only in the first patient, due to oversizing. The following periprocedural complications were observed: one femoral pseudoaneurysm, three femoral hematomas and two minor oropharyngeal bleeds, resolved by local hemostatic measures. During a 12±8 month follow-up a mild peri-device flow and a thrombus adhering to the device, resolved under with enoxaparin therapy, were identified. The rate of transient ischemic attack (TIA)/stroke was lower than expected according to the CHADS2 score (0 vs. 6.7±2.2%). In our initial experience, this procedure proved to be a feasible, safe and effective alternative for atrial fibrillation patients in whom oral anticoagulation is not an option. Only relatively minor complications were observed, with a lower than expected TIA/stroke rate. Copyright © 2012 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

Characterization of Personal Privacy Devices (PPD) radiation pattern impact on the ground and airborne segments of the local area augmentation system (LAAS) at GPS L1 frequency

NASA Astrophysics Data System (ADS)

Alkhateeb, Abualkair M. Khair

Personal Privacy Devices (PPDs) are radio-frequency transmitters that intentionally transmit in a frequency band used by other devices for the intent purpose of denying service to those devices. These devices have shown the potential to interfere with the ground and air sub-systems of the Local Area Augmentation Systems (LAAS), a GPS-based navigation aids at commercial airports. The Federal Aviation Administration (FAA) is concerned by the potential impact of these devices to GPS navigation aids at airports and has commenced an activity to determine the severity of this threat. In support of this situation, the research in this dissertation has been conducted under (FAA) Cooperative Agreement 2011-G-012, to investigate the impact of these devices on the LAAS. In order to investigate the impact of PPDs Radio Frequency Interference (RFI) on the ground and air sub-systems of the LAAS, the work presented in phase one of this research is intended to characterize the vehicle's impact on the PPD's Effective Isotropic Radiated Power (EIRP). A study was conceived in this research to characterize PPD performance by examining the on-vehicle radiation patterns as a function of vehicle type, jammer type, jammer location inside a vehicle and jammer orientation at each location. Phase two was to characterize the GPS Radiation Pattern on Multipath Limiting Antenna. MLA has to meet stringent requirements for acceptable signal detection and multipath rejection. The ARL-2100 is the most recent MLA antenna proposed to be used in the LAAS ground segment. The ground-based antenna's radiation pattern was modeled. This was achieved via (HFSS) a commercial-off the shelf CAD-based modeling code with a full-wave electromagnetic software simulation package that uses the Finite Element Analysis. Phase three of this work has been conducted to study the characteristics of the GPS Radiation Pattern on Commercial Aircraft. The airborne GPS antenna was modeled and the resulting radiation pattern on

CIRSE Vascular Closure Device Registry

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

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

2011-02-15

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

CIRSE Vascular Closure Device Registry

PubMed Central

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

2010-01-01

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

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

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

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

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

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

PubMed

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

2018-01-01

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

Thromboembolism after WATCHMANTM in a clopidogrel non-responder: A case for concern?

PubMed

Venkataraman, Ganesh; Bliden, Kevin P; Tantry, Udaya S; Gurbel, Paul A

2017-11-11

Atrial fibrillation (AF) is associated with an increased risk of stroke and thromboembolism (TE). The WATCHMAN TM left atrial appendage (LAA) closure device is indicated to reduce the risk of TE from the LAA in patients with non-valvular AF. Here, we present a case of a patient with device-related thrombus who suffered a TE event two months after WATCHMAN TM LAA closure and two weeks after switching from aspirin plus warfarin to aspirin plus clopidogrel therapy. Laboratory investigation identified the patient to be hypercoagulable and to be a non-responder to clopidogrel therapy. We discuss the potential role of platelet function testing to prevent device-related thrombi. © 2017 Wiley Periodicals, Inc.

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

Growth and characterization of single crystal rocksalt LaAs using LuAs barrier layers

NASA Astrophysics Data System (ADS)

Krivoy, E. M.; Rahimi, S.; Nair, H. P.; Salas, R.; Maddox, S. J.; Ironside, D. J.; Jiang, Y.; Dasika, V. D.; Ferrer, D. A.; Kelp, G.; Shvets, G.; Akinwande, D.; Bank, S. R.

2012-11-01

We demonstrate the growth of high-quality, single crystal, rocksalt LaAs on III-V substrates; employing thin well-behaved LuAs barriers layers at the III-V/LaAs interfaces to suppress nucleation of other LaAs phases, interfacial reactions between GaAs and LaAs, and polycrystalline LaAs growth. This method enables growth of single crystal epitaxial rocksalt LaAs with enhanced structural and electrical properties. Temperature-dependent resistivity and optical reflectivity measurements suggest that epitaxial LaAs is semimetallic, consistent with bandstructure calculations in literature. LaAs exhibits distinct electrical and optical properties, as compared with previously reported rare-earth arsenide materials, with a room-temperature resistivity of ˜459 μΩ-cm and an optical transmission window >50% between ˜3-5 μm.

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

PubMed

Gingras, Kristen; Zaruby, Jeffrey; Maul, Don

2012-05-01

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

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.

EWOLUTION: Design of a registry to evaluate real-world clinical outcomes in patients with AF and high stroke risk-treated with the WATCHMAN left atrial appendage closure technology.

PubMed

Boersma, Lucas V A; Schmidt, Boris; Betts, Tim R; Sievert, Horst; Tamburino, Corrado; Teiger, Emmanuel; Stein, Kenneth M; Bergmann, Martin W

2016-09-01

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and the rate of ischemic stroke attributed to non-valvular AF is estimated at 5% per year. Several multi-center studies established left atrial appendage closure as a safe and effective alternative to oral anticoagulation, but there is a need for additional real world data. The purpose of this observational, prospective, single-arm, multicenter clinical study is to compile real-world clinical outcome data for WATCHMAN™ LAA (left atrial appendage) Closure Technology. One thousand subjects at up to 70 institutions in Europe, the Middle East, and Russia will be enrolled. Patients will be followed for 2 years after WATCHMAN implantation, according to standard medical practice. Primary endpoints include procedural and long-term data including stroke/embolism, bleeding, and death. This article presents the background of the LAAC device and describes the design of the study. Results for peri-procedural analyses are expected toward the end of 2015; long-term follow-up data are expected in the latter half of 2017. The EWOLUTION study will formally expand knowledge of LAA closure into a broader real world setting. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

Left Atrial Appendage Exclusion for Atrial Fibrillation

PubMed Central

Syed, Faisal F.; DeSimone, Christopher V.; Friedman, Paul A.; Asirvatham, Samuel J.

2015-01-01

SYNOPSIS Percutaneous left atrial appendage (LAA) closure is increasingly being used as a treatment strategy to prevent stroke in patients with atrial fibrillation (AF) who have contraindications to anticoagulants. A number of approaches and devices have been developed in the last few years, each with their own unique set of advantages and disadvantages. We review the published studies on surgical and percutaneous approaches to LAA closure; focusing on stroke mechanisms in AF, LAA structure and function relevant to stroke prevention, practical differences in procedural approach, and clinical considerations surrounding management. PMID:25443240

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

PubMed

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

2014-01-01

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

Efficacy and safety of left atrial appendage closure with WATCHMAN in patients with or without contraindication to oral anticoagulation: 1-Year follow-up outcome data of the EWOLUTION trial.

PubMed

Boersma, Lucas V; Ince, Hueseyin; Kische, Stephan; Pokushalov, Evgeny; Schmitz, Thomas; Schmidt, Boris; Gori, Tommaso; Meincke, Felix; Protopopov, Alexey Vladimir; Betts, Timothy; Foley, David; Sievert, Horst; Mazzone, Patrizio; De Potter, Tom; Vireca, Elisa; Stein, Kenneth; Bergmann, Martin W

2017-09-01

Left atrial appendage (LAA) occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials. EWOLUTION was designed to provide data in routine practice from a prospective multicenter registry. A total of 1025 patients scheduled for a WATCHMAN implant were prospectively and sequentially enrolled at 47 centers. Indication for LAA closure was based on European Society of Cardiology guidelines. Follow-up and transesophageal echocardiography (TEE) were performed per local practice. The baseline CHA 2 DS 2 -VASc score was 4.5 ± 1.6; the mean age was 73.4 ± 9 years; previous transient ischemic attack/ischemic stroke was present in 312 (30.5%), 155 (15.1%) had previous hemorrhagic stroke, and 320 (31.3%) had a history of major bleeding; and 750 (73%) were deemed unsuitable for oral anticoagulation therapy. WATCHMAN implant succeeded in 1005 (98.5%) of patients, without leaks >5 mm in 1002 (99.7%) with at least 1 TEE follow-up in 875 patients (87%). Antiplatelet therapy was used in 784 (83%), while vitamin K antagonists were used in only 75 (8%). At 1 year, mortality was 98 (9.8%), reflecting the advanced age and comorbidities in this population. Device thrombus was observed in 28 patients at routine TEE (3.7%) and was not correlated with the drug regimen (P = .14). Ischemic stroke rate was 1.1% (relative risk 84% vs estimated historical data); the major bleeding rate was 2.6% and was predominantly (2.3%) nonprocedure/device related. LAA closure with the WATCHMAN device has a high implant and sealing success. This method of stroke risk reduction appears to be safe and effective with an ischemic stroke rate as low as 1.1%, even though 73% of patients had a contraindication to and were not using oral anticoagulation. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

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.

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

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.

Transcatheter Closure of Patent Foramen Ovale: Devices and Technique.

PubMed

Price, Matthew J

2017-10-01

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

Percutaneous left atrial appendage occlusion: Effect of device positioning on outcome.

PubMed

Wolfrum, Mathias; Attinger-Toller, Adrian; Shakir, Samera; Gloekler, Steffen; Seifert, Burkhardt; Moschovitis, Aris; Khattab, Ahmed; Maisano, Francesco; Meier, Bernhard; Nietlispach, Fabian

2016-10-01

The study in patients with percutaneous left atrial appendage (LAA) occlusion investigates clinical outcomes according to the position of the Amplatzer Cardiac Plug (ACP) disc. The ACP consists of a disc and an anchoring lobe. The disc is meant to cover the ostium of the LAA, but frequently retracts partially or completely into the neck of the LAA. It is not known whether a retracted disc affects outcome. Outcomes of 169 consecutive patients (age 73.1 ± 10.4 years; 76% male) with successful LAA closure were analyzed according to the position of the ACP disc: group A had complete coverage of the LAA ostium; in group B the disc prolapsed partially or completely into the LAA-neck. Transesophageal echocardiography was performed 1-6 months after ACP implantation. The safety endpoint was the composite of clinically significant pericardial effusion, device embolization, procedure-related stroke/transient ischemic attack (TIA), major bleeding, or device thrombus. The efficacy endpoint was the composite of death, neurological events (ischemic and hemorrhagic stroke, TIA), or systemic embolism during follow-up. Group A comprised 76 patients (age 73.0 ± 9.9 years; 74% male) and group B 93 patients (age 73.3 ± 10.9 years; 79% male). Mean CHA 2 DS 2 -Vasc score and HASBLED score were 4.2 ± 1.7 (group A 4.3 ± 1.6; group B 4.2 ± 1.8) and 2.9 ± 1.1 (group A 2.9 ± 1.0; group B 3.0 ± 1.2), respectively. Mean follow-up of the study population was 13.0 ± 10.4 months. Overall, the composite safety and efficacy endpoints occurred in 20 (12%) and 6 patients (4%), respectively. There was no significant difference between groups A and B in the occurrence of the safety endpoint (13% vs. 11%, P = 0.64), or the efficacy endpoint (4% vs. 3%, P = 1.0). No evidence for a difference in the occurrence of the safety and efficacy endpoint was found between patients with complete vs. incomplete ACP disc coverage of the LAA ostium. The risk of

Right Ventricle before and after Atrial Septal Defect Device Closure.

PubMed

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

2016-09-01

Percutaneous atrial septal defect (ASD) device closure is a safe and effective means of reducing or eliminating interatrial shunting. The response of the right heart to device closure is incompletely understood. To evaluate the effects of transcatheter closure of secundum ASD on right ventricle size and function, that is, both systolic and diastolic by transthoracic echocardiography (TTE) over a 6-month period. Seventy-three patients had 73 device implantations. The patients were assessed with echocardiography before and at 1 and 6 months after procedure. Mean age was 26 ± 17 years. Mean ASD size indexed to body surface area (BSA) was 19.1 ± 8.6 mm/m(2) . The device size ranged from 12 to 42 mm. One month after closure, there were statistically significant decreases in right ventricular (RV) basal diameter (3.5 ± 0.7 cm vs. 4.2 ± 0.8 cm), RV/LV end-diastolic diameter ratio (0.9 ± 0.1 vs. 1.2 ± 0.2), left ventricular eccentricity index (LVEI) (1.0 ± 0.1 vs. 1.2 ± 0.2), right atrial (RA) major dimension (4.4 ± 0.8 cm vs. 4.8 ± 1.0 cm), RA end-systolic area (13.2 ± 4.6 cm(2) vs. 18.5 ± 6.7 cm(2) ), tricuspid annular plane systolic excursion (TAPSE) (2.2 ± 1.8 cm vs. 2.8 ± 0.5 cm), tricuspid annular systolic velocity (TASV or S') (13.1 ± 3.0 cm/sec vs. 16.0 ± 2.8 cm/sec), E/A (1.4 ± 0.3 vs. 1.7 ± 0.5), and E/e' (5.9 ± 5.0 vs. 7.2 ± 2.0) in comparison with baseline. Six months after closure, there were statistically significant decreases in RV major dimension (5.9 ± 1.1 cm vs. 6.3 ± 1.0 cm), RV/LV end-diastolic diameter ratio (0.8 ± 0.1 vs. 0.9 ± 0.1), RA major dimension (4.1 ± 0.8 cm vs. 4.4 ± 0.8 cm), and RA end-systolic area (11.4 ± 3.8 cm(2) vs. 13.2 ± 4.6 cm(2) ) in comparison with 1 month post-device closure. After 6 months, there was a statistically insignificant increase in both TASV (13.7 ± 2.8 cm/sec vs. 13.1 ± 3.0 cm/sec) and TAPSE (2.5 ± 1.6 cm/sec vs. 2.2 ± 1.8 cm/sec). There was no significant change in tissue Doppler MPI at

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

PubMed Central

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

2016-01-01

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

Nickel elution properties of contemporary interatrial shunt closure devices.

PubMed

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

2015-02-01

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

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.

First-principles investigations on elastic, thermodynamic and lattice thermal conductivity of topological insulator LaAs

NASA Astrophysics Data System (ADS)

Zhou, Yu; Cheng, Yan; Chen, Xiang-Rong; Hu, Cui-E.; Chen, Qi-Feng

2018-07-01

Topological insulators are always a hot topic owing to their various peculiar physical effects, which are useful in spintronics and quantum information processing. Herein, we systematically investigate the elastic, thermodynamic and lattice thermal conductivity of a new typical topological insulator LaAs by combining the first-principles approach and an iterative solution of the Boltzmann transport equation. The obtained elastic constants and other lattice structural parameters of LaAs are well consistent with the experimental and other theoretical results. For the first time, the lattice thermal conductivity (5.46 W/(m•K)) and mean free path (14.4 nm) of LaAs are obtained, which manifests that the LaAs is more likely to be a desirable thermoelectric material. It is noted that the obtained mode-averaged Grüneisen parameters by different ab initio simulation packages are very similar, suggesting that our results are rather responsible. From the phonon scattering rates of LaAs, we speculate that the reduction of acoustic-optical gap and the larger phonon scattering may jointly result in reduction of thermal conductivity for LaAs. Meanwhile, the temperature dependence curves of the lattice thermal conductivity, heat capacity and phonon mean free path are also presented. We expect our work can provide more information for further experimental studies.

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

PubMed

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

2014-12-01

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

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

PubMed

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

2012-08-03

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

Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial.

PubMed

Reddy, Vivek Y; Sievert, Horst; Halperin, Jonathan; Doshi, Shephal K; Buchbinder, Maurice; Neuzil, Petr; Huber, Kenneth; Whisenant, Brian; Kar, Saibal; Swarup, Vijay; Gordon, Nicole; Holmes, David

2014-11-19

While effective in preventing stroke in patients with atrial fibrillation (AF), warfarin is limited by a narrow therapeutic profile, a need for lifelong coagulation monitoring, and multiple drug and diet interactions. To determine whether a local strategy of mechanical left atrial appendage (LAA) closure was noninferior to warfarin. PROTECT AF was a multicenter, randomized (2:1), unblinded, Bayesian-designed study conducted at 59 hospitals of 707 patients with nonvalvular AF and at least 1 additional stroke risk factor (CHADS2 score ≥1). Enrollment occurred between February 2005 and June 2008 and included 4-year follow-up through October 2012. Noninferiority required a posterior probability greater than 97.5% and superiority a probability of 95% or greater; the noninferiority margin was a rate ratio of 2.0 comparing event rates between treatment groups. Left atrial appendage closure with the device (n = 463) or warfarin (n = 244; target international normalized ratio, 2-3). A composite efficacy end point including stroke, systemic embolism, and cardiovascular/unexplained death, analyzed by intention-to-treat. At a mean (SD) follow-up of 3.8 (1.7) years (2621 patient-years), there were 39 events among 463 patients (8.4%) in the device group for a primary event rate of 2.3 events per 100 patient-years, compared with 34 events among 244 patients (13.9%) for a primary event rate of 3.8 events per 100 patient-years with warfarin (rate ratio, 0.60; 95% credible interval, 0.41-1.05), meeting prespecified criteria for both noninferiority (posterior probability, >99.9%) and superiority (posterior probability, 96.0%). Patients in the device group demonstrated lower rates of both cardiovascular mortality (1.0 events per 100 patient-years for the device group [17/463 patients, 3.7%] vs 2.4 events per 100 patient-years with warfarin [22/244 patients, 9.0%]; hazard ratio [HR], 0.40; 95% CI, 0.21-0.75; P = .005) and all-cause mortality (3.2 events per 100 patient

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.

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

PubMed

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

2007-02-01

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

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

PubMed

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

2016-10-01

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

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

PubMed

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

2008-02-23

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

The Many-Headed Hydra: Information Networking at LAA.

ERIC Educational Resources Information Center

Winzenried, Arthur P.

1997-01-01

Describes an integrated computer library system installed at Lilydale Adventist Academy (LAA) in Melbourne (Australia) in response to a limited budget, increased demand, and greater user expectations. Topics include student workstations, cost effectiveness, CD-ROMS on local area networks, and student input regarding their needs. (Author/LRW)

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

PubMed

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

2016-05-01

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

[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.

Transcatheter closure of post-operative residual ventricular septal defect using a patent ductus arteriosus closure device in an adult: a case report.

PubMed

Djer, Mulyadi M; Idris, Nikmah S; Alwi, Idrus; Wijaya, Ika P

2014-07-01

Transcatheter closure of perimembranous and muscular ventricular septal defect (VSD) has been performed widely and it has more advantages compare to surgery. However, transcatheter closure of residual VSD post operation of complex congenital heart disease is still challenging because of the complexity of anatomy and concern about device stability, so the operator should meticulously choose the most appropriate technique and device. We would like to report a case of transcatheter closure of residual VSD post Rastelli operation in a patient with double outlet right ventricle (DORV), sub-aortic VSD, severe infundibulum pulmonary stenosis (PS) and single coronary artery. The patient had undergone operations for four times, but he still had intractable heart failure that did not response to medications. On the first attempt. we closed the VSD using a VSD occluder, unfortunately the device embolized into the descending aorta, but fortunately we was able to snare it out. Then we decided to close the VSD using a patent ductus arteriosus (PDA occluder). On transesophageal echocardiography (TEE) and angiography evaluation, the device position was stable. Post transcatheter VSD closure, the patient clinical condition improved significantly and he could finally be discharged after a long post-surgery hospitalization. Based on this experience we concluded that the transcatheter closure of residual VSD in complex CHD using PDA occluder could be an effective alternative treatment.

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.

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.

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

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

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

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

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

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

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.

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

PubMed

Rohit, Manoj Kumar; Gupta, Ankur

2017-05-01

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

Atrial septum defect closure device in a beating heart, from the perspective of a researcher in artificial organs.

PubMed

Tomizawa, Yasuko

2012-12-01

Transcatheter closure of atrial septum defect (ASD) with a closure device is increasing, but the history of clinical use of this procedure is still short, and the efficacy and long-term safety remain unproved. The total number of closure devices implanted throughout the world has not been counted accurately. Therefore, the probability of complications occurring after implantation is uncertain. Device-related complications that occur suddenly late after implantation are life-threatening, and quite often necessitate emergency surgical intervention. In Japanese medical journals, authors reporting closure devices have mentioned no complications and problems in their facilities. Detailed studies of device-related complications and device removal have not been reported in Japan. In fact, this literature search found an unexpectedly large number of reports of various adverse events from many overseas countries. When follow-up duration is short and the number of patients is small, the incidence of complications cannot be determined. Rare complications may emerge in a large series with a long observation period. Consequently, the actual number of incidents related to ASD closure devices is possibly several times higher than the number reported. Guidelines for long-term patient management for patients with an implanted closure device are necessary and post-marketing surveillance is appropriate. Development of a national database, a worldwide registration system, and continuous information disclosure will improve the quality of treatment. The devices currently available are not ideal in view of reports of late complications requiring urgent surgery and the need for life-long follow-up. An ideal device should be free from complications during life, and reliability is indispensable.

Port closure techniques.

PubMed

Shaher, Z

2007-08-01

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

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

PubMed

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

2013-02-01

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

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

PubMed

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

2012-06-01

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

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

PubMed Central

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

2010-01-01

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

Safety and Procedural Success of Left Atrial Appendage Exclusion With the Lariat Device: A Systematic Review of Published Reports and Analytic Review of the FDA MAUDE Database.

PubMed

Chatterjee, Saurav; Herrmann, Howard C; Wilensky, Robert L; Hirshfeld, John; McCormick, Daniel; Frankel, David S; Yeh, Robert W; Armstrong, Ehrin J; Kumbhani, Dharam J; Giri, Jay

2015-07-01

The Lariat device has received US Food and Drug Administration (FDA) 510(k) clearance for soft-tissue approximation and is being widely used off-label for left atrial appendage (LAA) exclusion. A comprehensive analysis of safety and effectiveness has not been reported. To perform a systematic review of published literature to assess safety and procedural success, defined as successful closure of the LAA during the index procedure, of the Lariat device. We performed a formal analytic review of the FDA MAUDE (Manufacturer and User Facility Device Experience) database to compile adverse event reports from real-world practice with the Lariat. For the systematic review, PubMed, EMBASE, CINAHL, and the Cochrane Library were searched from January 2007 through August 2014 to identify all studies reporting use of the Lariat device in 3 or more patients. The FDA MAUDE database was queried for adverse events reports related to Lariat use. Data were abstracted in duplicate by 2 physician reviewers. Events from published literature were pooled using a generic inverse variance weighting with a random effects model. Cumulative and individual adverse events were also reported using the FDA MAUDE data set. Procedural adverse events and procedural success. In the systematic review, 5 reports of Lariat device use in 309 participants were identified. Specific complications weighted for inverse of variance of individual studies were urgent need for cardiac surgery (2.3%; 7 of 309 procedures) and death (0.3%; 1 of 309 procedures). Procedural success was 90.3% (279 of 309 procedures). In the FDA MAUDE database, there were 35 unique reports of adverse events with use of the Lariat device. Among these, we identified 5 adverse event reports that noted pericardial effusion and death and an additional 23 reported urgent cardiac surgery without mention of death. This review of published reports and case reports identified risks of adverse events with off-label use of the Lariat device for LAA

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)

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

PubMed

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

2012-01-01

The study aims to evaluate the safety and feasibility of intra-operative device closure of atrial septal defect with transthoracic minimal invasion. 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. 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). 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 cosmetic results, and leaving less trauma than surgical closure.

5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials.

PubMed

Reddy, Vivek Y; Doshi, Shephal K; Kar, Saibal; Gibson, Douglas N; Price, Matthew J; Huber, Kenneth; Horton, Rodney P; Buchbinder, Maurice; Neuzil, Petr; Gordon, Nicole T; Holmes, David R

2017-12-19

The PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that left atrial appendage closure (LAAC) with the Watchman device (Boston Scientific, St. Paul, Minnesota) was equivalent to warfarin for preventing stroke in atrial fibrillation, but had a high rate of complications. In a second randomized trial, PREVAIL (Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy), the complication rate was low. The warfarin cohort experienced an unexpectedly low ischemic stroke rate, rendering the efficacy endpoints inconclusive. However, these outcomes were based on relatively few patients followed for a relatively short time. The final results of the PREVAIL trial, both alone and as part of a patient-level meta-analysis with the PROTECT AF trial, are reported with patients in both trials followed for 5 years. PREVAIL and PROTECT AF are prospective randomized clinical trials with patients randomized 2:1 to LAAC or warfarin; together, they enrolled 1,114 patients for 4,343 patient-years. Analyses are by intention-to-treat, and rates are events per 100 patient-years. For the PREVAIL trial, the first composite coprimary endpoint of stroke, systemic embolism (SE), or cardiovascular/unexplained death did not achieve noninferiority (posterior probability for noninferiority = 88.4%), whereas the second coprimary endpoint of post-procedure ischemic stroke/SE did achieve noninferiority (posterior probability for noninferiority = 97.5%); the warfarin arm maintained an unusually low ischemic stroke rate (0.73%). In the meta-analysis, the composite endpoint was similar between groups (hazard ratio [HR]: 0.820; p = 0.27), as were all-stroke/SE (HR: 0.961; p = 0.87). The ischemic stroke/SE rate was numerically higher with LAAC, but this difference did not reach statistical significance (HR: 1.71; p = 0.080). However, differences in

Computed tomography measurement of the left atrial appendage for optimal sizing of the Watchman device.

PubMed

Xu, Bo; Betancor, Jorge; Sato, Kimi; Harb, Serge; Abdur Rehman, Karim; Patel, Kunal; Kumar, Arnav; Cremer, Paul C; Jaber, Wael; Rodriguez, L Leonardo; Schoenhagen, Paul; Wazni, Oussama

Percutaneous left atrial appendage (LAA) occlusion is an emerging treatment option for patients with non-valvular atrial fibrillation who cannot tolerate oral anticoagulation. The Watchman device (Boston Scientific Corporation, Natick, MA, USA) is deployed at the ostium of the LAA, and an appropriately sized device is critical for successful occlusion. However, standardized imaging protocols for device sizing have not been established. We investigated the clinical utility of a standardized imaging protocol, with pre-procedural multi-detector cardiac computed tomography (MDCT), and intra-procedural transesophageal echocardiography (TEE), for Watchman device sizing. Patients who underwent Watchman device implantation between 2010 and 2016 at our center, and who had pre-procedural MDCT and intra-procedural TEE were included. MDCT measurements (CTmax, CTmin, CTmean), and TEE measurement (TEEmax) of the LAA ostium were determined for each case, and correlated with the final size of the Watchman device implanted. Demographic data and clinical outcomes were collected. The study included 80 patients (mean age: 75 ± 9.6 years; male: 68%; mean CHA2DS2-VASc score: 4.5 ± 1.4). CTmax of the LAA ostium correlated strongly with the final deployed Watchman device size (Spearman's rho: 0.81, p < 0.001), while TEEmax of the LAA ostium showed only moderate correlation with the final deployed Watchman device size (Spearman's rho: 0.61, p < 0.001). Implantation success rate was 100%. At a mean duration of follow-up of 197 days, there were no device-related complications (device embolization, cardiac perforation and pericardial tamponade). At follow-up, the vast majority of patients (76 patients; 95%) had either no or trivial (≤3 mm) residual peri-device leak on TEE. A standardized imaging protocol for assessment of Watchman device implantation incorporating pre-procedural MDCT and intra-procedural TEE, was associated with excellent procedural outcomes at a mean duration

Left Atrial Appendage Closure in Atrial Fibrillation: A World without Anticoagulation?

PubMed Central

Contractor, Tahmeed; Khasnis, Atul

2011-01-01

Atrial Fibrillation (AF) is a common arrhythmia with an incidence that is as high as 10% in the elderly population. Given the large proportion of strokes caused by AF as well as the associated morbidity and mortality, reducing stroke burden is the most important part of AF management. While warfarin significantly reduces the risk of AF-related stroke, perceived bleeding risks and compliance limit its widespread use in the high-risk AF population. The left atrial appendage is believed to be the “culprit” for thrombogenesis in nonvalvular AF and is a new therapeutic target for stroke prevention. The purpose of this review is to explore the evolving field of percutaneous LAA occlusion. After briefly highlighting the risk of stroke with AF, problems with warfarin, and the role of the LAA in clot formation, this article discusses the feasibility and efficacy of various devices which have been developed for percutaneous LAA occlusion. PMID:21559225

LaaA, a novel high-active alkalophilic alpha-amylase from deep-sea bacterium Luteimonas abyssi XH031(T).

PubMed

Song, Qinghao; Wang, Yan; Yin, Chong; Zhang, Xiao-Hua

2016-08-01

Alpha-amylase is a kind of broadly used industrial enzymes, most of which have been exploited from terrestrial organism. Comparatively, alpha-amylase from marine environment was largely undeveloped. In this study, a novel alkalophilic alpha-amylase with high activity, Luteimonas abyssi alpha-amylase (LaaA), was cloned from deep-sea bacterium L. abyssi XH031(T) and expressed in Escherichia coli BL21. The gene has a length of 1428bp and encodes 475 amino acids with a 35-residue signal peptide. The specific activity of LaaA reached 8881U/mg at the optimum pH 9.0, which is obvious higher than other reported alpha-amylase. This enzyme can remain active at pH levels ranging from 6.0 to 11.0 and temperatures below 45°C, retaining high activity even at low temperatures (almost 38% residual activity at 10°C). In addition, 1mM Na(+), K(+), and Mn(2+) enhanced the activity of LaaA. To investigate the function of potential active sites, R227G, D229K, E256Q/H, H327V and D328V mutants were generated, and the results suggested that Arg227, Asp229, Glu256 and Asp328 were total conserved and essential for the activity of alpha-amylase LaaA. This study shows that the alpha-amylase LaaA is an alkali-tolerant and high-active amylase with strong potential for use in detergent industry. Copyright © 2016 Elsevier Inc. All rights reserved.

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

PubMed

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

2008-06-01

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

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

PubMed Central

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

2005-01-01

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

Self-expanding nanoplatinum-coated nitinol devices for atrial septal defect and patent ductus arteriosus closure: a swine model.

PubMed

Lertsapcharoen, Pornthep; Khongphatthanayothin, Apichai; La-orkhun, Vidhavas; Supachokchaiwattana, Pentip; Charoonrut, Phingphol

2006-01-01

Our purpose was to evaluate self-expanding nanoplatinum-coated nitinol devices for transcatheter closure of atrial septal defects and patent ductus arteriosus in a swine model. The devices were braided from platinum-activated nitinol wires and filled with polyester to enhance thrombogenicity. The platinum activation of the nitinol wires was carried out with the help of Nanofusion technology. The coating of platinum covers the exposed surface of the nitinol wires and prevents the release of nickel into the blood stream after the implantation of the device but does not affect its shape memory, which makes the device self-expanding after it is loaded from the catheter. Atrial septal defects were created in 12 piglets by balloon dilation of the patent foramen ovale. The size of the device was selected on the basis of the diameter of the balloon and the size of the defect, measured by transthoracic echocardiography. The devices were successfully deployed in all 12 piglets under fluoroscopic study. Transthoracic color Doppler echocardiograms showed complete closure of the atrial septal defect within 15 minutes of device implantation. Twelve patent ductus arteriosus closure devices were deployed in the right or left subclavian arteries in 10 piglets. Angiograms showed complete occlusion of the subclavian arteries within a few minutes of device deployment. In the atrial septal defect cases, the autopsy findings showed complete organizing fibrin thrombus formation and complete neo-endothelialization on the outer surface of the devices within one week and six weeks of implantation, respectively. The use of self-expanding nanoplatinum-coated nitinol devices for the transcatheter closure of atrial septal defects and patent ductus arteriosus is feasible. The excellent occlusion result and complete neo-endothelialization of the devices in the swine model is an indication of the potential of these devices in human application.

Intraoperative device closure of atrial septal defects with inferior vena cava rim deficiency: a safe alternative to surgical repair.

PubMed

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

2011-03-01

Our objective was to evaluate the safety and feasibility of intraoperative device closure of atrial septal defects with inferior vena cava rim deficiency. From January 2005 to December 2008, we enrolled 65 patients who had a secundum atrial septal defect with inferior vena cava rim deficiency closure in our institution. Patients were divided into 2 groups: 35 patients in group I underwent intraoperative device closure with a right lateral minithoracotomy and 30 in group II underwent open cardiac repair with a right lateral thoracotomy and cardiopulmonary bypass. Intraoperative device closure involved a minimal intercostal incision that 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. The procedure was successful in all patients. In group I, the diameter of the atrial septal defect ranged from 30 to 44 mm (mean, 35.3 ± 3.9 mm), and the size of the implanted occluder ranged from 34 to 48 mm (mean, 40 ± 2.1 mm). The total occlusion rate was 82.9% immediately after the operation, 97.1% at 3 months, and 100% at 12 and 24 months of follow-up. In group II, all patients had successful closure. A follow-up period of 12 to 24 months was obtained in both groups. During the follow-up, there was no recurrence, thrombosis, or device failure. In our comparative studies, group II had significantly longer operative time, intensive care unit stay, and hospital stay than group I (P < .001). The cost of group I was less than that of group II (20,450.9 ± 840.8 RMB vs 25,884.9 ± 701.8; P < .001). Intraoperative device closure of atrial septal defects with inferior vena cava rim deficiency is a safe and feasible technique. It has the advantages of cost savings, cosmetic results, and less trauma than surgical closure. Early and midterm results are encouraging. Crown Copyright © 2011. Published by Mosby, Inc. All rights reserved.

Vascular Closure Devices in Interventional Radiology Practice

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

Patel, Rafiuddin, E-mail: rafiuddin.patel@ouh.nhs.uk; Muller-Hulsbeck, Stefan, E-mail: muehue@diako.de; Morgan, Robert, E-mail: robert.morgan@stgeorges.nhs.uk

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, whichmore » 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.« less

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

PubMed

Kiran, Viralam S; Tiwari, Ashish

2018-04-06

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

Left ventricular remodeling and change of systolic function after closure of patent ductus arteriosus in adults: device and surgical closure.

PubMed

Jeong, Young-Hoon; Yun, Tae-Jin; Song, Jong-Min; Park, Jung-Jun; Seo, Dong-Man; Koh, Jae-Kon; Lee, Se-Whan; Kim, Mi-Jeong; Kang, Duk-Hyun; Song, Jae-Kwan

2007-09-01

Left ventricular (LV) remodeling and predictors of LV systolic function late after closure of patent ductus arteriosus (PDA) in adults remain to be clearly demonstrated. In 45 patients with PDA, including 28 patients who received successful occlusion using the Amplatzer device (AD group) (AGA, Golden Valley, MN) and 17 patients who received surgical closure (OP group), echocardiography studies were performed before closure and 1 day (AD group) or within 7 days (OP group) after closure, and then were repeated at > or = 6 months (17 +/- 13 months). In both groups, LV ejection fraction (EF) and end-diastolic volume index were significantly decreased immediately after closure, whereas end-systolic volume index did not change. During the long-term follow-up period, end-systolic as well as end-diastolic volume indices decreased significantly in both groups and LV EF recovered compared to the immediate postclosure state. However, LV EF remained low compared to the preclosure state. Five patients (11.1%) including 3 patients in the AD group and 2 patients in the OP group showed persistent late LV systolic dysfunction (EF <50%). In stepwise, multiple logistic regression analysis, preclosure EF was the only independent predictor of late normal postclosure EF (odds ratio, 1.230; 95% CI, 1.054-1.434; P = .008). Receiver operating characteristic curve analysis showed that preclosure EF > or = 62% had a sensitivity of 72% and a specificity of 83% for predicting late normal LV EF after closure. Left ventricular EF remains low late after PDA closure compared with preclosure state in adults. Preclosure LV EF is the best index to predict late postclosure LV EF.

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

PubMed

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

2008-06-01

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

Effect of Dietary L-ascorbic Acid (L-AA) on Production Performance, Egg Quality Traits and Fertility in Japanese Quail (Coturnix japonica) at Low Ambient Temperature.

PubMed

Shit, N; Singh, R P; Sastry, K V H; Agarwal, R; Singh, R; Pandey, N K; Mohan, J

2012-07-01

Environmental stress boosts the levels of stress hormones and accelerates energy expenditure which subsequently imbalance the body's homeostasis. L-ascorbic acid (L-AA) has been recognized to mitigate the negative impact of environmental stress on production performances in birds. The present investigation was carried out to elucidate the effect of different dietary levels of L-AA on production performance, egg quality traits and fertility in Japanese quail at low ambient temperature. Sixty matured females (15 wks) were equally divided into three groups (20/group) based on the different dietary levels of L-AA (0, 250 and 500 ppm) and coupled with an equal number of males (1:1) obtained from the same hatch. They were managed in uniform husbandry conditions without restriction of feed and water at 14 h photo-schedule. Except for feed efficiency, body weight change, feed consumption and hen-day egg production were recorded highest in 500 ppm L-AA supplemented groups. Among the all egg quality traits studied, only specific gravity, shell weight and thickness differed significantly (p<0.05) in the present study. Fertility was improved significantly (p<0.01) to a dose dependent manner of L-AA. The findings of the present study concluded that dietary L-AA can be a caring management practice at least in part to alleviate the adverse effect of cold induced stress on production performance in Japanese quail.

[Outcome of transcatheter closure of perimembranous ventricular septal defect with modified double-disk occluder device].

PubMed

Liu, Jing; You, Xiao-hua; Zhao, Xian-xian; Hu, Jian-qiang; Cao, Jiang; Xu, Rong-liang; Wu, Hong; Chen, Shao-ping; Zhang, Jian-liang; Zheng, Xing; Qin, Yong-wen

2010-04-01

To evaluate the efficacy and adverse effects of transcatheter closure of perimembranous ventricular septal defect (pmVSD) with modified double-disk occluder device (MDVO). Clinical data including clinical examination, electrocardiography daily after the procedure for a week, chest-X-rays and TTE before discharge and at 3-5 days after the procedure were analyzed from 604 patients underwent percutaneous closure of a pmVSD with MDVO at our department between December 2001 and December 2008. Procedure was successful in 576 out of 604 patients (95.4%) and 583 VSD occluders were placed. Endocarditis, thromboembolism, or deaths were not observed after procedure. Conduction block occurred in 81 patients (56 RBBB, 14 LBBB) and transient nonparoxysmal ventricular tachycardia in 31 patients after the procedure. Complete heart block occurred in 11 patients, 9 of them recovered in 3 weeks, permanent pacemaker was implanted in 2 patients (one had transient III degrees AVB before the procedure, the other underwent simultaneous closure of ventricular septal defect and atrial septal defect). Trivial/small residual shunts were found in 69 patients (12.0%). The residual shunts disappeared in 31 patients and remained unchanged in 38 patients (6.6%) 7 days after procedures. Aortic regurgitation developed in 5 patients (2 trivial/small, 3 small/moderate), and tricuspid regurgitation was present in 35 patients (32 trivial/small, 3 moderate). Five patients developed haemolysis (device retrieved via catheter in 1 patient due to persistent haemolysis, the other 4 patients recovered 3-14 days post procedure). Pseudoaneurysm of femoral artery occurred in 1 patient, and disappeared by pressure dressing. Device was successfully replaced in 2 patients with either device embolization (n = 1) or device misplacement (n = 1) after device retrieval by catheter. It is safe and effective to close congenital perimembranous ventricular septal defect with domestic-made occluder device.

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.

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

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

PubMed

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

2007-03-01

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

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

PubMed

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

2018-05-30

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

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.

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

PubMed

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

2013-08-20

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

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

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

Pieper, Claus Christian, E-mail: claus.christian.pieper@ukb.uni-bonn.de; Thomas, Daniel, E-mail: daniel.thomas@ukb.uni-bonn.de; Nadal, Jennifer, E-mail: jennifer.nadal@ukb.uni-bonn.de

PurposeTo intra-individually compare discomfort levels and patient satisfaction after arterial access closure using the ExoSeal{sup ®} vascular closure device (VCD) and manual compression (MC) in a prospective study design.MethodsPatients undergoing two planned interventions from 07/2013 to 09/2014 could participate in the study. Access closure was performed with an ExoSeal{sup ®}-VCD in one and MC in the other intervention. Patients were clinically and sonographically examined and were given questionnaires 1 day after intervention [groin- and back-pain during bedrest (100-point visual analog scale; 0: no pain); comfortability of bedrest (10-point Likert scale, 1: comfortable), satisfaction with closure (10-point Likert scale, 1: very satisfied)].more » Results were analyzed in a cross-over design.Results48 patients (29 male, median age 62.5 (32–88) years) were included. An ExoSeal{sup ®}-VCD was used first in 25 cases. As four of these subsequently refused MC as second intervention, data from 44 patients could be analyzed. All closures were technically successful (successful device deployment) without major complications. Groin- and back-pain after VCD-use/MC was 0 (0–15) vs. 10 (0–80) and 0 (0–75) vs. 25 (0–90), respectively (p < 0.0001). Bedrest after VCD-use was more comfortable than after MC [1 (range 1–7) vs. 6 (2–10); p < 0.0001]. Satisfaction with the closure procedure and with the intervention in general was higher after VCD-use compared to MC [1 (1–3) vs. 5 (2–10) and 1 (1–2) vs. 2 (1–4), respectively; p < 0.0001].ConclusionIntra-individual comparison showed pain levels and discomfort to be significantly lower after ExoSeal{sup ®} use compared to MC. VCD closure was associated with higher satisfaction both with the closure itself and with the intervention in general.« less

Percutaneous ligation of the left atrial appendage results in atrial electrical substrate modification.

PubMed

Syed, Faisal F; Rangu, Venu; Bruce, Charles J; Johnson, Susan B; Danielsen, Andrew; Gilles, Emily J; Ladewig, Dorothy J; Mikell, Susan B; Berhow, Steven; Wahnschaffe, Douglas; Suddendorf, Scott H; Asirvatham, Samuel J; Friedman, Paul A

2015-03-01

Debulking of electrically active atrial tissue may reduce the mass of fibrillating tissue during atrial fibrillation, eliminate triggers, and promote maintenance of normal sinus rhythm (NSR). We investigated whether left atrial appendage (LAA) ligation results in modification of atrial electrical substrate. Healthy male mongrel dogs (N = 20) underwent percutaneous epicardial LAA ligation. The ligation system grabber recorded LAA local electrograms (EGM) continuously before, during, and after closure. Successful ligation with a preloaded looped suture was confirmed intraprocedurally by LAA Doppler flow cessation on transesophageal echocardiography (TEE) and loss of LAA electrical activity, and after procedure by direct necropsic visualization. P-wave duration on surface electrocardiograms was measured immediately before and after LAA closure. Percent P-wave duration reduction was correlated with preclosure LAA internal dimensions measured by TEE and external dimensions measured on necropsy specimens to investigate associations of LAA geometry with the extent of electrical substrate modification. LAA ligation was successful in all dogs and accompanied by loss of LAA EGM. P-wave duration reduced immediately on ligation (mean 75 ms preligation to 63 ms postligation; mean difference ± standard error, 12 ± 1 ms; P < 0.0001). Percent P-wave reduction was associated with larger LAA longitudinal cross-sectional area (R(2) = 0.263, P = 0.04) and smaller external circumference (R(2) = 0.687, P = 0.04). All dogs were in sinus rhythm. Percutaneous LAA ligation results in its acute electrical isolation and atrial electrical substrate modification, the degree of which is associated with LAA geometry. These electrical changes raise the possibility that LAA ligation may promote NSR by removing LAA substrate and triggers. Copyright © 2015 Elsevier Inc. All rights reserved.

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.

ASD Closure in Structural Heart Disease.

PubMed

Wiktor, Dominik M; Carroll, John D

2018-04-17

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

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

PubMed Central

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

2014-01-01

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

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.

27 CFR 26.136 - Affixing closures.

Code of Federal Regulations, 2012 CFR

2012-04-01

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

27 CFR 26.136 - Affixing closures.

Code of Federal Regulations, 2013 CFR

2013-04-01

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

27 CFR 26.136 - Affixing closures.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

27 CFR 26.136 - Affixing closures.

Code of Federal Regulations, 2014 CFR

2014-04-01

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

27 CFR 26.136 - Affixing closures.

Code of Federal Regulations, 2011 CFR

2011-04-01

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

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

PubMed

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

2017-04-25

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

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

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

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

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

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

PubMed

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

2014-06-01

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

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

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

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

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

Percutaneous management of coronary sinus atrial septal defect: two cases representing the spectrum for device closure and a review of the literature.

PubMed

Sandeep, Nefthi; Slack, Michael C

2014-10-01

Coronary sinus atrial septal defects are the rarest defects of the atrial septum comprising <1% of the five different types of atrial septal defects. Despite the widespread adoption of percutaneous device closure of secundum atrial septal defects, the published experience with percutaneous device closure of coronary sinus atrial septal defects is limited to only a few isolated case reports because of uncertainty regarding safety and efficacy. Open-heart surgical repair remains the treatment of choice for coronary sinus atrial septal defects, although this may not be the only treatment option in selected cases. Herein we describe our own experience with two patients with different clinical presentations and our method of successful percutaneous coronary sinus atrial septal defect closure in each. We then present a review of the anatomic spectrum of coronary sinus atrial septal defects along with a review of contemporary surgical and percutaneous device treatment.

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.

Transcatheter umbrella closure of valvular and paravalvular leaks.

PubMed

Hourihan, M; Perry, S B; Mandell, V S; Keane, J F; Rome, J J; Bittl, J A; Lock, J E

1992-11-15

Our aim was to adapt the technique of transcatheter umbrella closure of intracardiac defects for closure of valvular and paravalvular defects. The double-umbrella device developed by Rashkind and Cuaso has been safely and effectively delivered across a host of intracardiac defects, but transcatheter closure of valvular and paravalvular leaks has not been reported. Between February 1987 and September 1990, eight patients who were believed to be poor operative candidates were taken to the catheterization laboratory for transcatheter double-umbrella closure of a valvular or a paravalvular leak. Four patients had a paravalvular leak around a prosthetic aortic valve. The other four patients had a valvular leak: one patient with a regurgitant native aortic valve after a Stansel procedure and three patients with a regurgitant porcine valve in a left ventricular apex to descending aorta conduit. Placement of a double-umbrella device was attempted in seven of the eight patients and was successful in all seven. Device placement was not attempted in one patient because of the crescentic shape of his defect. Two patients required two devices for each closure; the other five required only one device each. Angiography, performed on six patients after device closure, demonstrated that three patients had a completely occluded defect, two had trivial residual flow and one patient had mild residual flow through the device. All significant complications occurred in one patient who had hemolysis and oliguria that resolved when the initial umbrella was replaced by a larger device. In addition, two devices migrated to the patient's pulmonary arteries but were retrieved in the catheterization laboratory without difficulty. No other early or late complications occurred in 21 to 50 months of follow-up. Of the four patients with a paravalvular leak, the one who did not receive a device died at operation, one patient died at operation for an associated defect (in the operating room the

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

PubMed

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

2017-06-01

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

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.

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

PubMed

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

2008-05-01

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

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

PubMed

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

2013-11-01

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

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

Is the new Occlutech duct occluder an appropriate device for transcatheter closure of patent ductus arteriosus?

PubMed

Godart, François; Houeijeh, Ali; Domanski, Olivia; Guillaume, Marie-Paule; Brard, Mélanie; Lucron, Hugues

2018-06-15

To describe our initial experience with the Occlutech Duct Occluder (ODO) for percutaneous closure of patent ductus arteriosus (PDA). Retrospective review of patients undergoing transcatheter PDA closure with the ODO in 2 academic centers. From April 2013 to September 2017, 42 patients underwent PDA closure. Median age at implantation was 34 months (range 4 months-68 years) and median weight was 12 kg (range 4.1-57 kg). Ducts were Krichenko type A duct (n = 34), type E (n = 6), and type C (n = 2). The mean duct diameter was 3.76 mm (range 1.69 to 9.95 mm, median 3.1 mm). Implantation succeeded in all. There was neither device embolization nor hemolysis. At device release, immediate angiogram showed a small residual shunt in 54.7%. During follow-up, Doppler echocardiography demonstrated 71% of full occlusion at day one, rising to 95% at one month and 100% at one year and half after implantation. The mean maximal systolic pressure gradient in left pulmonary artery was 4.2 ± 4.3 mm and across the distal aortic arch 5.4 ± 4.7 mm Hg. No patient had any significant stenosis with clinical relevance. ODO is safe and effective in transcatheter closure of PDA including relatively large sized ducts. The results are satisfactory with a high level of full occlusion and a low rate of complications. Further evaluation with larger studies and longer follow-up will be required to confirm these preliminary good results. Copyright © 2018. Published by Elsevier B.V.

Transapical access closure: the TA PLUG device†

PubMed Central

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

2013-01-01

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

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

PubMed Central

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

2016-01-01

Abstract Aims Atrial fibrillation (AF) patients with contraindications to oral anticoagulation have had few options for stroke prevention. Recently, a novel oral anticoagulant, apixaban, and percutaneous left atrial appendage closure (LAAC) have emerged as safe and effective therapies for stroke risk reduction in these patients. This analysis assessed the cost effectiveness of LAAC with the Watchman device relative to apixaban and aspirin therapy in patients with non-valvular AF and contraindications to warfarin therapy. Methods and results A cost-effectiveness model was constructed using data from three studies on stroke prevention in patients with contraindications: the ASAP study evaluating the Watchman device, the ACTIVE A trial of aspirin and clopidogrel, and the AVERROES trial evaluating apixaban. The cost-effectiveness analysis was conducted from a German healthcare payer perspective over a 20-year time horizon. Left atrial appendage closure yielded more quality-adjusted life years (QALYs) than aspirin and apixaban by 2 and 4 years, respectively. At 5 years, LAAC was cost effective compared with aspirin with an incremental cost-effectiveness ratio (ICER) of €16 971. Left atrial appendage closure was cost effective compared with apixaban at 7 years with an ICER of €9040. Left atrial appendage closure was cost saving and more effective than aspirin and apixaban at 8 years and remained so throughout the 20-year time horizon. Conclusions This analysis demonstrates that LAAC with the Watchman device is a cost-effective and cost-saving solution for stroke risk reduction in patients with non-valvular AF who are at risk for stroke but have contraindications to warfarin. PMID:26838691

Left Atrial Appendage Electrical Isolation and Concomitant Device Occlusion to Treat Persistent Atrial Fibrillation: A First-in-Human Safety, Feasibility, and Efficacy Study.

PubMed

Panikker, Sandeep; Jarman, Julian W E; Virmani, Renu; Kutys, Robert; Haldar, Shouvik; Lim, Eric; Butcher, Charles; Khan, Habib; Mantziari, Lilian; Nicol, Edward; Foran, John P; Markides, Vias; Wong, Tom

2016-07-01

Left atrial appendage (LAA) electric isolation is reported to improve persistent atrial fibrillation (AF) ablation outcomes. However, loss of LAA mechanical function may increase thromboembolic risk. Concomitant LAA electric isolation and occlusion as part of conventional AF ablation has never been tested in humans. We therefore evaluated the feasibility, safety, and efficacy of LAA electric isolation and occlusion in patients undergoing long-standing persistent AF ablation. Patients with long-standing persistent AF (age, 68±7 years; left atrium diameter, 46±3 mm; and AF duration, 25±15 months) underwent AF ablation, LAA electric isolation, and occlusion. Outcomes were compared with a balanced (1:2 ratio) control group who had AF ablation alone. Among 22 patients who underwent ablation, LAA electric isolation was possible in 20. Intraprocedural LAA reconnection occurred in 17 of 20 (85%) patients, predominantly at anterior and superior locations. All were reisolated. LAA occlusion was successful in all 20 patients. There were no major periprocedural complications. Imaging at 45 days and 9 months confirmed satisfactory device position and excluded pericardial effusion. One of twenty (5%) patients had a gap of ≥5 mm requiring anticoagulation. Nineteen of twenty (95%) patients stopped warfarin at 3 months. Without antiarrhythmic drugs, freedom from AF at 12 months after a single procedure was significantly higher in the study group (19/20, 95%) than in the control group (25/40, 63%), P=0.036. Freedom from atrial arrhythmias was demonstrated in 12 of 20 (60%) and 18 of 20 (90%) patients after 1 and ≤2 procedures (mean, 1.3), respectively. Persistent AF ablation, LAA electric isolation, and mechanical occlusion can be performed concomitantly. This technique may improve the success of persistent AF ablation while obviating the need for chronic anticoagulation. URL: https://clinicaltrials.gov. Unique identifier: NCT02028130. © 2016 American Heart Association, Inc.

Closure Devices for Iatrogenic Thoraco-Cervical Vascular Injuries

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

Makris, Gregory C., E-mail: g.makris09@doctors.org.uk; Patel, Rafiuddin; Little, Mark

IntroductionThe unintentional arterial placement of a central venous line can have catastrophic complications. The purpose of this systematic review is to assess and analyse the available evidence regarding the use of the various vascular closure devices (VCDs) for the management of iatrogenic thoraco-cervical arterial injuries (ITCAI).MethodsA systematic review was performed according to PRISMA guidelines.ResultsThirty-two relevant case series and case reports were identified with a total of 69 patients having being studied. In the majority of the studies, plug-based VCDs were used (81%) followed by suture-based devices (19%). The majority of studies reported successful outcomes from the use of VCDs inmore » terms of achieving immediate haemostasis without any acute complications. Long-term follow-up data were only available in nine studies with only one case of carotid pseudoaneurysm being reported after 1-month post-procedure. All other cases had no reported long-term complications. Five studies performed direct or indirect comparisons between VCDs and other treatments (open surgery or stent grafting) suggesting no significant differences in safety or effectiveness.ConclusionAlthough there is limited evidence, VCDs appear to be safe and effective for the management of ITCAIs. Further research is warranted regarding the effectiveness of this approach in comparison to surgery and in order to identify those patients who are more likely to benefit from this minimally invasive approach.« less

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.

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

PubMed

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

2017-06-01

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

Comparing the Tolerability of a Novel Wound Closure Device Using a Porcine Wound Model

PubMed Central

Townsend, Katy L.; Akeroyd, Jen; Russell, Duncan S.; Kruzic, Jamie J.; Robertson, Bria L.; Lear, William

2018-01-01

Objective: To compare the tolerability and mechanical tensile strength of acute skin wounds closed with nylon suture plus a novel suture bridge device (SBD) with acute skin wounds closed with nylon suture in a porcine model. Approach: Four Yucatan pigs each received 12 4.5 cm full-thickness incisions that were closed with 1 of 4 options: Suture bridge with nylon, suture bridge with nylon and subdermal polyglactin, nylon simple interrupted, and nylon simple interrupted with subdermal polyglactin. Epithelial reaction, inflammation, and scarring were examined histologically at days 10 and 42. Wound strength was examined mechanically at days 10 and 42 on ex vivo wounds from euthanized pigs. Results: Histopathology in the suture entry/exit planes showed greater dermal inflammation with a simple interrupted nylon suture retained for 42 days compared with the SBD retained for 42 days (p < 0.03). While tensile wound strength in the device and suture groups were similar at day 10, wounds closed with the devices were nearly 8 times stronger at day 42 compared with day 10 (p < 0.001). Innovation: A novel SBD optimized for cutaneous wound closure that protects the skin surface from suture strands, forms a protective bridge over the healing wound edges, and knotlessly clamps sutures. Conclusion: This study suggests that the use of a SBD increases the tolerability of nylon sutures in porcine acute skin wound closures allowing for prolonged mechanical support of the wound. For slow healing wounds, this may prevent skin wound disruption, such as edge necrosis and dehiscence. PMID:29892494

Successful use of a left ventricular apical access and closure device for second-generation transapical aortic valve implantation.

PubMed

Conradi, Lenard; Seiffert, Moritz; Shimamura, Kazuo; Schirmer, Johannes; Blankenberg, Stefan; Reichenspurner, Hermann; Diemert, Patrick; Treede, Hendrik

2014-09-01

Transcatheter aortic valve implantation (TAVI) has become routine for the treatment of high-risk patients with aortic stenosis. We assessed safety and feasibility of a left ventricular apical access and closure device combined with second-generation transapical (TA) TAVI transcatheter heart valves (THV). Three elderly, comorbid patients (logEuroSCORE I 13.0-31.1%) received transapical aortic valve implantation (TA-AVI) via the Apica ASC device (Apica Cardiovascular Ltd., Galway, Ireland) using second-generation THV (Medtronic Engager [Medtronic 3F Therapeutics, Santa Ana, California, United States], JenaValve [JenaValve Technology GmbH, Munich, Germany], Symetis Acurate [Symetis S.A., Ecublens, Switzerland]). Access was gained using a non-rib-spreading technique and a novel access and closure device. THV deployment was successful with excellent hemodynamic outcome (no PVL, n = 2; trace PVL, n = 1; mean transvalvular gradients, 5-19 mm Hg) and complete apical hemostasis. No periprocedural major adverse events occurred and Valve Academic Research Consortium-2-defined composite end point of device success was met in all cases. Safety and feasibility of TA-AVI using the ASC device with second-generation THV was demonstrated. Combining latest available technology is a major step toward improved functional outcome and decreased surgical trauma in TA-AVI. Potentially, technical enhancements may eventually pave the way toward a fully percutaneous TA-AVI procedure. Georg Thieme Verlag KG Stuttgart · New York.

Management of hidradenitis suppurativa wounds with an internal vacuum-assisted closure device.

PubMed

Chen, Y Erin; Gerstle, Theodore; Verma, Kapil; Treiser, Matthew D; Kimball, Alexandra B; Orgill, Dennis P

2014-03-01

Hidradenitis suppurativa is a chronic, debilitating disease that is difficult to treat. Once medical management fails, wide local excision offers the best chance for cure. However, the resultant wound often proves too large or contaminated for immediate closure. The authors performed a retrospective chart review of hidradenitis cases managed surgically between 2005 and 2010. Data collected included patient characteristics, management method, and outcomes. Approximately half of the patients received internal vacuum-assisted closure therapy using the vacuum-assisted closure system and delayed closure and half of the patients received immediate primary closure at the time of their excision. Delayed closure consisted of closing the majority of the wound in a linear fashion following internal vacuum-assisted closure while accepting healing by means of secondary intention for small wound areas. Patients managed with internal vacuum-assisted closure had wounds on average four times larger in area than patients managed without internal vacuum-assisted closure. In both groups, all wounds were eventually closed primarily. Healing times averaged 2.2 months with internal vacuum-assisted closure and 2.7 months without. At an average follow-up time of 2.3 months, all patients with internal vacuum-assisted closure had no recurrence of their local disease. Severe hidradenitis presents a treatment challenge, as surgical excisions are often complicated by difficult closures and unsatisfactory recurrence rates. This study demonstrates that wide local excision with reasonable outcomes can be achieved using accelerated delayed primary closure. This method uses internal vacuum-assisted closure as a bridge between excision and delayed primary closure, facilitating closure without recurrence in large, heavily contaminated wounds. Therapeutic, III.

Efficacy of a novel procedure sheath and closure device during diagnostic catheterization: the multicenter randomized clinical trial of the FISH device.

PubMed

Bavry, Anthony A; Raymond, Russell E; Bhatt, Deepak L; Chambers, Charles E; DeNardo, Andrew J; Hermiller, James B; Myers, Paul R; Pitts, Douglas E; Scott, John A; Savader, Scott J; Steinhubl, Steven

2008-04-01

The aim of vascular closure devices is to safely secure the arterial access site at the conclusion of catheterization procedures, thereby increasing patient comfort and decreasing time to hemostasis and ambulation. The FISH (femoral introducer sheath and hemostasis) device is novel in that the access sheath and closure component are incorporated onto the same system. The FISH pivotal investigation was conducted at 8 catheterization laboratories throughout the United States. Eligible diagnostic patients were randomized (2 to 1) to the FISH device versus manual compression and assessed for time to hemostasis and time to ambulation. Half of the participants underwent ultrasonographic evaluation at 30-day follow up. Enrollment for an interventional cohort is ongoing and will be reported at a later date; however, the interventional patients enrolled to date were combined with the diagnostic patients to comprise the safety data of the trial. Overall, 191 patients were randomized to the FISH device and 106 patients to manual compression. Most patients received a 6 Fr sheath (approximately 70%), while the remaining patients received a 5 or 8 Fr sheath. Twenty-seven patients who received the FISH device were converted to manual compression due to anticipated suboptimal hemostasis. Among the diagnostic patients, the mean time to hemostasis was 8.9 minutes for the FISH device, compared to 17.2 minutes for manual compression (p < 0.0001). Similarly, the mean time to ambulation was 2.4 hours for the FISH device, compared to 4.3 hours for manual compression (p < 0.0001). Among the total cohort, there was 1 death and 1 episode of major access-site-related bleeding that required transfusion occurred in the FISH group (1.1%), compared to no serious adverse safety events in the manual compression group (p = 1.0). For the FISH group, there were 5 minor adverse safety events; 3 access-site hematomas and 2 pseudoaneurysms treated with thrombin injection, and in the manual compression

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

PubMed

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

2012-06-01

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

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

PubMed

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

2016-05-27

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

Angle closure glaucoma in congenital ectropion uvea.

PubMed

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

2018-06-01

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

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

PubMed

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

2014-02-01

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

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.

Epicardial clip occlusion of the left atrial appendage during cardiac surgery provides optimal surgical results and long-term stability.

PubMed

Kurfirst, Vojtech; Mokrácek, Aleš; Canádyová, Júlia; Frána, Radim; Zeman, Petr

2017-07-01

Occlusion of the left atrial appendage (LAA) has become an integral and important part of the surgical treatment of atrial fibrillation. Different methods of surgical occlusion of the LAA have been associated with varying levels of short- and long-term success for closure. The purpose of this study was to evaluate long-term results of epicardial placement and endocardial occlusion in patients undergoing cardiac operative procedures. A total of 101 patients (average age 65.7 years) undergoing cardiac operative procedures with the epicardial AtriClip Exclusion System of the LAA were enrolled in the study. The AtriClip was placed via a sternotomy or a thoracotomy or from a thoracoscopic approach. Postoperative variables, such as thromboembolic events, clip stability and endocardial leakage around the device, were examined by transoesophageal echocardiography (TEE) and/or computed tomography. Perioperative clip implantation was achieved in 98% of patients. TEE and/or computed tomography conducted during the follow-up period, comprising 1873 patient-months with a mean duration of 18 ± 11 months, revealed no clip migration, no leakage around the device and no clot formation near the remnant cul-de-sac. During the follow-up period, 4 of the cardiac patients experienced transitory ischaemic attacks, whereas no patient experienced a cerebrovascular attack. The Epicardial AtriClip Exclusion System of the LAA appears to be a feasable and safe operative method with a high success rate. Long-term follow-up confirmed clip stability, complete occlussion of the LAA and absence of any atrial fibrilation-related thromboembolic events. These results need to be confirmed by a larger, multicentre study. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Intracardiac echocardiography: use during transcatheter device closure of a patent ductus arteriosus in a dog.

PubMed

Chetboul, V; Damoiseaux, C; Behr, L; Morlet, A; Moise, N S; Gouni, V; Lavennes, M; Pouchelon, J-L; Laborde, F; Borenstein, N

2017-06-01

Intracardiac echocardiography (ICE) is used in humans for percutaneous interventional procedures, such as transcatheter device closures. Intracardiac echocardiography provides high-resolution imaging of cardiac structures with two-dimensional, M-mode, Doppler, and also three-dimensional modalities. The present report describes application of ICE during transcatheter occlusion of patent ductus arteriosus using a canine ductal occluder in a dog for which transesophageal echocardiography could not provide an optimal acoustic window. Copyright © 2017 Elsevier B.V. All rights reserved.

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.

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

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

Minko, Peter, E-mail: peterminko@yahoo.com; Katoh, Marcus; Graeber, Stefan

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),more » 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.« less

A proof-of-concept study of the VeinScrew: A new percutaneous venous closure device.

PubMed

Boersma, Doeke; de Borst, Gert Jan; Moll, Frans L

2017-02-01

Objective This study evaluated the concept of percutaneous closure of insufficient veins using the VeinScrew principle. Methods The VeinScrew is designed to place a spring-shaped implant that contracts and clamps around the vein. The ability of the device to occlude adequately was tested in a bench model experiment. The feasibility of accurate placement and adequate venous occlusion was evaluated in an animal experiment and in a human cadaveric experiment. Results The VeinScrew implant occluded up to a pressure of 135 mmHg. In vivo studies confirmed that deployment was challenging but technically feasible, and subsequent phlebography showed closure of the vein. The cadaveric study showed that percutaneous placement of the evolved VeinScrew around the great saphenous vein was feasible and accurate. Conclusions The current studies show the feasibility of the VeinScrew concept. Future developments and translational studies are necessary to determine the potential of this technique as a new option in the phlebologist's toolbox.

Temporary abdominal closure with zipper-mesh device for management of intra-abdominal sepsis.

PubMed

Utiyama, Edivaldo Massazo; Pflug, Adriano Ribeiro Meyer; Damous, Sérgio Henrique Bastos; Rodrigues, Adilson Costa; Montero, Edna Frasson de Souza; Birolini, Claudio Augusto Vianna

2015-01-01

to present our experience with scheduled reoperations in 15 patients with intra-abdominal sepsis. we have applied a more effective technique consisting of temporary abdominal closure with a nylon mesh sheet containing a zipper. We performed reoperations in the operating room under general anesthesia at an average interval of 84 hours. The revision consisted of debridement of necrotic material and vigorous lavage of the involved peritoneal area. The mean age of patients was 38.7 years (range, 15 to 72 years); 11 patients were male, and four were female. forty percent of infections were due to necrotizing pancreatitis. Sixty percent were due to perforation of the intestinal viscus secondary to inflammation, vascular occlusion or trauma. We performed a total of 48 reoperations, an average of 3.2 surgeries per patient. The mesh-zipper device was left in place for an average of 13 days. An intestinal ostomy was present adjacent to the zipper in four patients and did not present a problem for patient management. Mortality was 26.6%. No fistulas resulted from this technique. When intra-abdominal disease was under control, the mesh-zipper device was removed, and the fascia was closed in all patients. In three patients, the wound was closed primarily, and in 12 it was allowed to close by secondary intent. Two patients developed hernia; one was incisional and one was in the drain incision. the planned reoperation for manual lavage and debridement of the abdomen through a nylon mesh-zipper combination was rapid, simple, and well-tolerated. It permitted effective management of severe septic peritonitis, easy wound care and primary closure of the abdominal wall.

A Challenging Case of Patent Ductus Arteriosus Device Closure in an Adult with Unconventional Views and Catheters

PubMed Central

Garg, Naveen; Raja, Deep Chandh; Khanna, Roopali; Kumar, Sudeep

2018-01-01

Abnormally oriented patent ductus arteriosus is expected in adults, which can lead to difficulties while attempting a device closure. Alternate angiographic views like the “right anterior oblique view,” “retrograde approach” and in rare cases, as elicited in the following case scenario, special catheters like the “Tiger® catheter” can aid in crossing the lesion and completion of the procedure successfully. PMID:29876027

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

PubMed

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

2013-01-01

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

Cost savings associated with prevention of recurrent lumbar disc herniation with a novel annular closure device: a multicenter prospective cohort study.

PubMed

Parker, Scott L; Grahovac, Gordan; Vukas, Duje; Ledic, Darko; Vilendecic, Milorad; McGirt, Matthew J

2013-09-01

Same-level recurrent disc herniation is a well-defined complication following lumbar discectomy. Reherniation results in increased morbidity and health care costs. Techniques to reduce these consequences may improve outcomes and reduce cost after lumbar discectomy. In a prospective cohort study, we set out to evaluate the cost associated with surgical management of recurrent, same-level lumbar disc herniation following primary discectomy. Forty-six consecutive European patients undergoing lumbar discectomy for a single-level herniated disc at two institutions were prospectively followed with clinical and radiographic evaluations. A second consecutive cohort of 30 patients undergoing 31 lumbar discectomies with implantation of an annular closure device was followed at the same hospitals and same follow-up intervals. Cost estimates for reherniation were modeled on Medicare national allowable payment amounts (direct cost) and patient work-day losses (indirect cost). Annular closure and control cohorts were matched at baseline. By 2 years follow-up, symptomatic recurrent same-level disc herniation occurred in three (6.5%) patients in the control cohort versus zero (0%) patients in the annular closure cohort. For patients experiencing recurrent disc herniation, mean estimated direct and indirect cost of management of recurrent disc herniation was $34,242 and $3,778, respectively. Use of an annular closure device potentially results in a cost savings of $222,573 per 100 primary discectomy procedures performed (or $2,226 per discectomy), based solely on the reduction of reoperated reherniations when modeled on U.S. Medicare costs. Recurrent disc herniation did not occur in any patients after annular closure within the 12-month follow-up. The reduction in the incidence of reherniation was associated with potentially significant cost savings. Development of novel techniques to prevent recurrent lumbar disc herniation is warranted to decrease the associated morbidity and

AMPLATZER versus Figulla occluder for transcatheter patent foramen ovale closure.

PubMed

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

2017-04-20

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

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

Transcatheter closure of ventricular septal defect with Occlutech Duct Occluder.

PubMed

Atik-Ugan, Sezen; Saltik, Irfan Levent

2018-04-01

Patent ductus arteriosus occluders are used for transcatheter closure of ventricular septal defects, as well as for closure of patent ductus arteriosus. The Occlutech Duct Occluder is a newly introduced device for transcatheter closure of patent ductus arteriosus. Here, we present a case in which the Occlutech Duct Occluder was successfully used on a patient for the closure of a perimembraneous ventricular septal defect.

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

Atrial septal defect closure with the new Cardia Ultrasept II™ device with interposed Goretex patch: Mexican experience - has the perforation of Ivalon's membrane been solved?

PubMed

Mijangos-Vázquez, Roberto; García-Montes, Antonio J; Soto-López, Elena M; Guarner-Lans, Verónica; Zabal, Carlos

2018-05-01

The objective of this study was to demonstrate the safety and feasibility of using the new Cardia Ultrasept II™ device with interposed Goretex patch referring to the perforation of polyvinyl alcohol membrane. Great advances have been made in the development of devices for closure of atrial septal defect. The Cardia Ultrasept II™ with interposed Goretex patch is the modified last generation of Cardia devices, having the advantage of a super-low profile within the atria and an integral locking delivery-retrieval mechanism that ensures safe deployment. In addition, with the interposition of the Goretex, it has been possible to abolish perforation of Ivalon's membrane as a complication.Methods and resultsPatients with ostium secundum atrial septal defect with surrounding rims with a minimum length of 5 mm and who underwent atrial septal defect closure with the new Ultrasept II™ with Goretex patch were included from two paediatric cardiac centres. Primary end point was to determine perforation of the Goretex membrane at follow-up; secondary end point included right ventricular diastolic diameter. In total, 30 patients underwent atrial septal defect closure at a median age of 6 (1-29) years. At follow-up for 6 (range, 1-15) months, freedom from perforations was 100%. A continuous decrease in right ventricular diastolic diameter was found with an initial median of 30 (25-49) mm and after catheterisation of 27.5 (18-33) mm, p=0.01, and Z-score of 2.6 (1.7-3.6) versus 1.9 (1-2.9) after procedure, p=0.01. The new modified generation of the Ultrasept II™ device with interposed Goretex patch is a good alternative to achieve atrial septal defect closure safely and feasibly with no membrane perforation at follow-up.

Percutaneous closure of patent ductus arteriosus in children using amplatzer duct occluder II: relationship between PDA type and risk of device protrusion into the descending aorta.

PubMed

Masri, Samer; El Rassi, Issam; Arabi, Mariam; Tabbakh, Anas; Bitar, Fadi

2015-08-01

To compare the efficacy and safety of Amplatzer Duct Occluder II (ADOII) among the various patent ductus arteriosus (PDA) types, and to assess the association between development of aortic obstruction and the PDA type in terms of measurable parameters as the device angulation and distance of upper end protrusion into the aortic lumen. Retrospective cohort study involving 50 consecutive subjects who underwent ADO II device closure of PDA. The median age and weight at intervention were 13 months (5.5 months to 18 years) and 11 (6-67) kg respectively. The median smallest ductal diameter by angiography was 3.2 (1.9-5.4) mm. Thirty two patients had type A PDA, 5 had type C, 5 had type D, and 8 had type E. Residual shunt was seen in only 1 patient who had a tubular PDA and resolved within 2 months of the procedure. No device embolization or pulmonary side protrusion were noted. There was a 16% aortic protrusion rate. The median distance of protrusion of the upper end of the device into the aortic lumen was 3.1 (0-9) mm and the median angle formed between the aortic end of the device and the PDA take-off was 10.4 (0-80.6) degrees. These latter parameters of aortic obstruction were significantly higher in the non-conical PDA group as compared to the conical PDA. Nevertheless, there was no significant coarctation due to aortic retention disc protrusion. Device closure of PDA using the ADO II is a safe procedure for chosen types of PDA. We demonstrated a novel technique for objective assessment of device protrusion into the descending aorta based on measurable parameters. ADOII device closure of non-conical PDAs warrants closer follow ups. © 2015 Wiley Periodicals, Inc.

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

PubMed

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

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

Simple Skin-Stretching Device in Assisted Tension-Free Wound Closure.

PubMed

Cheng, Li-Fu; Lee, Jiunn-Tat; Hsu, Honda; Wu, Meng-Si

2017-03-01

Numerous conventional wound reconstruction methods, such as wound undermining with direct suture, skin graft, and flap surgery, can be used to treat large wounds. The adequate undermining of the skin flaps of a wound is a commonly used technique for achieving the closure of large tension wounds; however, the use of tension to approximate and suture the skin flaps can cause ischemic marginal necrosis. The purpose of this study is to use elastic rubber bands to relieve the tension of direct wound closure for simultaneously minimizing the risks of wound dehiscence and wound edge ischemia that lead to necrosis. This retrospective study was conducted to evaluate our clinical experiences with 22 large wounds, which involved performing primary closures under a considerable amount of tension by using elastic rubber bands in a skin-stretching technique after a wide undermining procedure. Assessment of the results entailed complete wound healing and related complications. All 22 wounds in our study showed fair to good results except for one. The mean success rate was approximately 95.45%. The simple skin-stretching design enabled tension-free skin closure, which pulled the bilateral undermining skin flaps as bilateral fasciocutaneous advancement flaps. The skin-stretching technique was generally successful.

Simple skin-stretching device in assisted tension-free wound closure

PubMed Central

Cheng, Li-Fu; Lee, Jiunn-Tat; Hsu, Honda; Wu, Meng-Si

2017-01-01

Background Numerous conventional wound reconstruction methods such as wound undermining with direct suture, skin graft, and flap surgery can be used to treat large wounds. The adequate undermining of the skin flaps of a wound is a commonly used technique for achieving the closure of large tension wounds; however, the use of tension to approximate and suture the skin flaps can cause ischemic marginal necrosis. The purpose of this study is to use elastic rubber bands to relieve the tension of direct wound closure for simultaneously minimizing the risks of wound dehiscence and wound edge ischemia that lead to necrosis. Materials and Methods This retrospective study was conducted to evaluate our clinical experiences with 22 large wounds, which involved performing primary closures under a considerable amount of tension by using elastic rubber bands in a skin-stretching technique following a wide undermining procedure. Assessment of the results entailed complete wound healing and related complications. Results All 22 wounds in our study showed fair to good results except for one. The mean success rate was approximately 95.45%. Conclusion The simple skin-stretching design enabled tension-free skin closure, which pulled the bilateral undermining skin flaps as bilateral fasciocutaneous advancement flaps. The skin-stretching technique was generally successful. PMID:28195891

A new cable-tie based sternal closure system: description of the device, technique of implantation and first clinical evaluation

PubMed Central

2012-01-01

Background Wire closure still remains the preferred technique despite reasonable disadvantages. Associated complications, such as infection and sternal instability, cause time- and cost-consuming therapies. We present a new tool for sternal closure with its first clinical experience and results. Methods The sternal ZipFixTM System is based on the cable-tie principle. It primarily consists of biocompatible Poly-Ether-Ether-Ketone implants and is predominantly used peristernally through the intercostal space. The system provides a large implant-to-bone contact for better force distribution and for avoiding bone cut through. Results 50 patients were closed with the ZipFixTM system. No sternal instability was observed at 30 days. Two patients developed a mediastinitis that necessitated the removal of the device; however, the ZipFixTM were intact and the sternum remained stable. Conclusions In our initial evaluation, the short-term results have shown that the sternal ZipFixTM can be used safely and effectively. It is fast, easy to use and serves as a potential alternative for traditional wire closure. PMID:22731778

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.

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

PubMed

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

2013-12-01

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

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

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.

Outcomes of mechanical stapling for postlaryngectomy open pharyngotomy closure.

PubMed

Paddle, Paul; Husain, Inna; McHugh, Lauren; Franco, Ramon

2017-03-01

A total laryngectomy (TL) is performed as a primary or salvage therapy for laryngeal carcinoma. Pharyngotomy closure after TL is typically performed using manual sutures. Automatic stapling devices are routinely used in thoracoabdominal surgery, but have not been widely accepted for use in pharyngotomy closure. Previously described closed stapling techniques of pharyngeal closure do not allow direct evaluation of surgical margins and are limited to endolaryngeal disease. We describe an open technique for pharyngotomy closure using a mechanical stapling device. Retrospective review. A review was conducted of 16 total laryngectomies performed from May 2008 to August 2015 utilizing an Ethicon Endopath ETS Compact-Flex 45 stapler. Sixteen patients (15 male, one female), mean age 69 years, received open TL (14 salvage, two primary) with endostapler pharyngeal closure and primary tracheoesophageal puncture (TEP). Surgical time averaged 218 minutes. Median time to swallowing was 4 days (range, 2-240 days) and mean hospital stay 6 days (range, 3-10 days). Fistula incidence was 31% (5/16) overall and 36% (5/14) in the postradiation patients. Mechanical stapling is a simple method for postlaryngectomy open pharyngotomy closure. This technique allows evaluation of margins, easy primary TEP, and the opportunity for early swallowing and shorter hospital stays. In addition, it can be performed for closure of salvage laryngectomies with rates of fistula formation similar to that found in the literature using suture closure techniques. Future studies are necessary to compare oncological results and surgical complications between the open and closed stapling techniques and to traditional suture closure. 4 Laryngoscope, 127:605-610, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

Laas Geel (somaliland): 5000 Year-Old Paintings Captured in 3D

NASA Astrophysics Data System (ADS)

Grenier, L.; Antoniotti, P.; Hamon, G.; Happe, D.

2013-07-01

Discovered in 2002 by a French archaeology team conducted by Prof. X. Gutherz, Laas Geel (Somaliland), is probably one of the most remarkable archaeological site in the horn of Africa. Located in an isolated arid region, it is made of natural rocky shelters on which hundreds of colored paintings still remain in a particularly good state of conservation. The first studies achieved in the last decade let suppose that they are 5000 years old. After several studying and exploring expeditions, a 3Ddigitizing campaign has been carried out by Art Graphique et Patrimoine, under the direction of X. Gutherz, with the support of the cultural service of the French Embassy in Djibouti. The project was focused on three main goals: production of a high accuracy 3D-documentation for scientific needs, archiving the 3D digital print recorded on site for the conservation and the saving of this heritage, and finally diffusing the results throughout various kinds of media to reveal the site to the public, insisting on its vulnerability.

Goose-neck snare-assisted transcatheter ASD closure: A safety procedure for large and complex ASDs.

PubMed

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

2016-04-01

To report on a new technique that increases the safety of percutaneous atrial septal defect (ASD) closure using a goose-neck snare system. ASD transcatheter closure is a widespread procedure. However, in some cases, ASDs may be large and with soft rims. In these situation, a potential risk exists for device malposition or embolization. When transesophageal echocardiography (TEE) evaluation and balloon sizing showed large defects with floppy rims the chosen Amplatzer device was implanted in a standard way. In large defects with floppy rims, before release a 5-mm goose-neck snare with its 4 Fr catheter was placed across the delivery cable and fixed to catch the screwing mechanism of implanted Amplatzer device. The delivery cable was unscrewed and the device reached its final position without any tension. If the position was considered satisfactory the device was released from the goose-neck snare. Thirteen patients had a snare-assisted ASD transcatheter closure. Median device size was 24 mm (range 14-38 mm). Retrieval or repositioning of the device using the goose-neck snare was performed in four cases: in three patients, because of device malposition after delivery cable release and in one patient, because of unsuitability of closure of a second significant defect. Furthermore, in two subjects with multiple ASDs, a second fenestration looked quite significant with the device still attached to the delivery cable while it appeared smaller after release. Snare-assisted Amplatzer ASD device placement is a new method for ASD percutaneous closure and adds safety to the procedure. © 2016 Wiley Periodicals, Inc.

Percutaneous closure of patent foramen ovale without echocardiographic guidance.

PubMed

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

2007-01-01

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

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

DOEpatents

Cawthorne, Duane C.

1997-05-27

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

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

DOEpatents

Cawthorne, D.C.

1997-05-27

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

Closure of patent foramen ovale: when and how?

PubMed

Lisignoli, Veronica; Lanzone, Alberto M; Zavalloni, Dennis; Pagnotta, Paolo; Presbitero, Patrizia

2007-10-01

Percutaneous closure of a patent foramen ovale (PFO) was performed in 98 consecutive patients (mean age 52.5 +/- 13 years, 61 women). Indications included recurrent transient ischaemic attack (47%), cryptogenic stroke (34%), peripheral embolism (11%), disabling migraine with aura (4%), professional scuba diving (1 pt) and severe platypnea-orthodeoxia syndrome (1 pt). Each PFO was characterized by transesophageal echocardiography (TEE) according to anatomy, degree of shunt (1-mild, 2-moderate, 3-severe), right atrial anatomical features relevant for PFO closure (such as presence of an Eustachian valve, Chiari network, lipomatosis or absence of septum secundum) with a new classification scheme. According to this classification successful device delivery was obtained in 100% of pts. Major complications included heparin-induced thrombocytopenia in 1 pt and device dislodgment in 1 pt; minor complications were mostly related to the catheter introduction site (2 pts) and mild immediate shunt (2 pts). In conclusion, percutaneous PFO closure based on strict anatomic criteria is a safe procedure with minimal periprocedural complications.

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

Perceptions of transcatheter device closure of patent ductus arteriosus in veterinary cardiology and evaluation of a canine model to simulate device placement: a preliminary study.

PubMed

Saunders, A B; Keefe, L; Birch, S A; Wierzbicki, M A; Maitland, D J

2017-06-01

The purpose of this study was to evaluate a canine patent ductus arteriosus (PDA) model developed for practicing device placement and to determine practices and perceptions regarding transcatheter closure of PDA from the veterinary cardiology community. A silicone model was developed from images obtained from a dog with a PDA and device placement was performed with catheter equipment and a document camera to simulate fluoroscopy. A total of 36 individuals including 24 diplomates and 12 residents participated, and the feedback was obtained. The study included an initial questionnaire, practice with the model, observation of device placement using the model, and a follow-up questionnaire. A total of 92% of participants including 100% of residents indicated they did not have the opportunity to practice device placement before performing the procedure and obtained knowledge of the procedure from reading journal articles or observation. Participants indicated selecting the appropriate device size (30/36, 83%) and ensuring the device is appropriately positioned before release (18/36, 50%) as the most common areas of difficulty with device placement. Confidence level was higher after practicing with the model for residents when compared with diplomates and for participants that had performed 1-15 procedures when compared with those that had performed >15 procedures. These findings suggest those that have performed fewer procedures may benefit the most from practicing with a model. This preliminary study demonstrates the feasibility of a PDA model for practicing device placement and suggests that there is a potential benefit from providing additional training resources. Copyright © 2017 Elsevier B.V. All rights reserved.

The LAAS network observation for studying time correlations in extensive air showers

NASA Astrophysics Data System (ADS)

Ochi, Nobuaki; Iyono, A.; Kimura, Hitoomi; Konishi, Takeharu; Nakamura, Toru; Nakatsuka, Takao; Ohara, Soji; Ohmori, Nobuharu; Saito, Katsuhiko; Takahashi, Nobusuke; Tsuji, Shuhei; Wada, Tomonori; Yamamoto, Isao; Yamashita, Yoshihiko; Yanagimoto, Yukio

2003-02-01

The Large Area Air Shower (LAAS) group has been performing a network observation of extensive air showers (EAS) since 1996 in Japan. Ten compact EAS arrays are operating simultaneously at distant stations (up to ≍1000 km) and detecting EAS with mean energy of ≍1015 eV. Each station has 4--12 scintillation counters and a Global Positioning System (GPS), which provides time stamps of EAS triggers with an accuracy of 1μs. As a consequence of the comparable time stamps, uniformly-adjusted detectors and a standardized data format among all stations, we can treat the independent observations as a gigantic EAS detector system as a whole. The primary purpose of the network observation is to study large-scale correlations in ultra-high-energy cosmic rays. On the other hand, three nearby stations within 1~km distance at Okayama area have a possibility to detect extremely-high-energy EAS (≍1019 eV) as coincident triggers of the three stations. The present status of the network and some results from computer simulations are reported here.

Results of the combined U.S. Multicenter Pivotal Study and the Continuing Access Study of the Nit-Occlud PDA device for percutaneous closure of patent ductus arteriosus.

PubMed

Moore, John W; Greene, Jessica; Palomares, Salvadore; Javois, Alexander; Owada, Carl Y; Cheatham, John P; Hoyer, Mark H; Jones, Thomas K; Levi, Daniel S

2014-12-01

This study aimed to compare the efficacy and safety of the Nit-Occlud PDA device (PFM Medical, Cologne, Germany) to benchmarks designed as objective performance criteria (OPC). The Nit-Occlud PDA is a nitinol coil-type patent ductus arteriosus (PDA) occluder with a reverse cone configuration, which is implanted using a controlled delivery system. Patients with <4-mm minimum diameter PDA were prospectively enrolled in the Pivotal and the Continuing Access Studies from 15 sites in the United States and were followed up for 12 months post-procedure. Investigator-reported outcomes were compared to OPC including a composite success criterion, efficacy criteria of successful closure (clinical and echocardiographic), and safety criteria incidence of adverse events (serious and of total). The Pivotal Study enrolled patients between November 1, 2002 and October 31, 2005, and the Continuing Access Study enrolled additional patients between September 1, 2006 and October 31, 2007. A total of 357 patients were enrolled, and 347 had successful device implantations. After 12 months, 96.8% had complete echocardiographic closure (OPC = 85%) and 98.1% had clinical closure (OPC = 95%). There were no deaths or serious adverse events (OPC = 1%). The total adverse event rate was 4.7% (OPC = 6%). Composite success was 95.1% in the study patients (OPC = 80%). Closure of small- and medium-sized PDA with the Nit-Occlud PDA is effective and safe when compared with OPC. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2004-08-01

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

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

PubMed Central

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

2015-01-01

AIM: To investigate long-term efficacy of two different devices more than five years after percutaneous atrial septal defect (ASD) closure in adults. METHODS: All patients who underwent percutaneous closure of an ASD in the St. Antonius Hospital, Nieuwegein, The Netherlands, between February 1998 and December 2006 were included. Percutaneous closure took place under general anaesthesia and transesophageal echocardiographic monitoring. Transthoracic echocardiography (TTE) was performed 24 h post-procedure to visualize the device position and to look for residual shunting using color Doppler. All complications were registered. All patients were invited for an outpatient visit and contrast TTE more than 5-years after closure. Efficacy was based on the presence of a residual right-to-left shunt (RLS), graded as minimal, moderate or severe. The presence of a residual left-to-right shunt (LRS) was diagnosed using color Doppler, and was not graded. Descriptive statistics were used for patients’ characteristics. Univariate analysis was used to identify predictors for residual shunting. RESULTS: In total, 104 patients (mean age 45.5 ± 17.1 years) underwent percutaneous ASD closure using an Amplatzer device (ASO) in 76 patients and a Cardioseal/Starflex device (CS/SF) in 28 patients. The mean follow-up was 6.4 ± 3.4 years. Device migration occurred in 4 patients of whom two cases occurred during the index hospitalization (1 ASO, 1 CS/SF). The other 2 cases of device migration occurred during the first 6 mo of follow-up (2 CS/SF). The recurrent thrombo-embolic event rate was similar in both groups: 0.4% per follow-up year. More than 12 mo post-ASD closure and latest follow-up, new-onset supraventricular tachyarrhythmia’s occurred in 3.9% and 0% for the ASO and CS/SF group, respectively. The RLS rate at latest follow-up was 17.4% (minimal 10.9%, moderate 2.2%, severe 4.3%) and 45.5% (minimal 27.3%, moderate 18.2%, severe 0%) for the ASO- and CS/SF groups, respectively

Catheter Ablation of Atrial Fibrillation in Patients with Hardware in the Heart - Septal Closure Devices, Mechanical Valves and More.

PubMed

Bartoletti, Stefano; Santangeli, Pasquale; DI Biase, Luigi; Natale, Andrea

2013-01-01

Patients with mechanical "hardware" in the heart, such as those with mechanical cardiac valves or atrial septal closure devices, represent a population at high risk of developing AF. Catheter ablation of AF in these subjects might represent a challenge, due to the perceived higher risk of complications associated with the presence of intracardiac mechanical devices. Accordingly, such patients were excluded or poorly represented in major trials proving the benefit of catheter ablation for the rhythm-control of AF. However, recent evidence supports the concept that catheter ablation procedures might be equally effective in these patients, without a significant increase in the risk of procedural complications. This review will summarize the current state-of-the-art on catheter ablation of AF in patients with mechanical "hardware" in the heart.

Incidence of pericardial effusion after left atrial appendage closure: The impact of underlying heart rhythm. data from the EWOLUTION study.

PubMed

Schmidt, Boris; Betts, Timothy R; Sievert, Horst; Bergmann, Martin W; Kische, Stephan; Pokushalov, Evgeny; Schmitz, Thomas; Meincke, Felix; Mazzone, Patrizio; Stein, Kenneth M; Ince, Hüseyin; Boersma, Lucas V A

2018-05-03

Pericardial effusion/tamponade (PE/PT) is a rare but serious complication following left atrial appendage closure (LAAC). It may be speculated that LAA contraction during sinus rhythm (SR) exerts mechanical force on the device that eventually leads to PE. We sought to determine the incidence and predictors of PE following LAAC using Watchman with special emphasis on the underlying heart rhythm during implant. From 47 centers in 13 European countries 1020 patients underwent LAAC and data on baseline rhythm were available from 1010 patients (mean age 73 ± 9 years, 60% male, median CHA2DS2-VASc = 4). Data were collected via electronic case report forms. A Cox-proportional hazard model was calculated adjusting for multiple variables: age, gender, number of recaptures and device oversizing. During implant, 41% and 59% of patients were in SR and atrial fibrillation (AF), respectively. PE/PT rate was significantly lower in patients implanted during AF at day 30 post implant (n = 1; 0.2% versus n = 6; 1.5%; p = 0.02). No PE requiring intervention occurred in the AF group compared to 5 events (1.2%) in the SR group (p = 0.01). While univariate analysis identified SR and gender as predictors for PE/tamponade, multivariate analysis only showed a statistical trend for both variables. The overall incidence of PE/PT was very low after LAAC using Watchman. Although SR was not identified as an independent predictor of PE/PT, all events requiring intervention occurred in patients with SR. It may be advisable to perform an extended echocardiographic follow-up in that patient population. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

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.

40 CFR 265.310 - Closure and post-closure care.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 27 2013-07-01 2013-07-01 false Closure and post-closure care. 265.310... DISPOSAL FACILITIES Landfills § 265.310 Closure and post-closure care. (a) At final closure of the landfill... subsoils present. (b) After final closure, the owner or operator must comply with all post-closure...

40 CFR 265.310 - Closure and post-closure care.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 27 2012-07-01 2012-07-01 false Closure and post-closure care. 265.310... DISPOSAL FACILITIES Landfills § 265.310 Closure and post-closure care. (a) At final closure of the landfill... subsoils present. (b) After final closure, the owner or operator must comply with all post-closure...

40 CFR 265.310 - Closure and post-closure care.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 26 2014-07-01 2014-07-01 false Closure and post-closure care. 265.310... DISPOSAL FACILITIES Landfills § 265.310 Closure and post-closure care. (a) At final closure of the landfill... subsoils present. (b) After final closure, the owner or operator must comply with all post-closure...

40 CFR 264.228 - Closure and post-closure care.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 25 2010-07-01 2010-07-01 false Closure and post-closure care. 264.228... Surface Impoundments § 264.228 Closure and post-closure care. (a) At closure, the owner or operator must... materials are left in place at final closure, the owner or operator must comply with all post-closure...

40 CFR 264.228 - Closure and post-closure care.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 27 2013-07-01 2013-07-01 false Closure and post-closure care. 264.228... Surface Impoundments § 264.228 Closure and post-closure care. (a) At closure, the owner or operator must... materials are left in place at final closure, the owner or operator must comply with all post-closure...

40 CFR 264.228 - Closure and post-closure care.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 27 2012-07-01 2012-07-01 false Closure and post-closure care. 264.228... Surface Impoundments § 264.228 Closure and post-closure care. (a) At closure, the owner or operator must... materials are left in place at final closure, the owner or operator must comply with all post-closure...

40 CFR 264.228 - Closure and post-closure care.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 26 2011-07-01 2011-07-01 false Closure and post-closure care. 264.228... Surface Impoundments § 264.228 Closure and post-closure care. (a) At closure, the owner or operator must... materials are left in place at final closure, the owner or operator must comply with all post-closure...

40 CFR 264.228 - Closure and post-closure care.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 26 2014-07-01 2014-07-01 false Closure and post-closure care. 264.228... Surface Impoundments § 264.228 Closure and post-closure care. (a) At closure, the owner or operator must... materials are left in place at final closure, the owner or operator must comply with all post-closure...

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

PubMed

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

2009-06-01

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

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

PubMed

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

2017-12-01

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

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.

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...

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

PubMed

Sanchez, Jessica N; Seckeler, Michael D

2017-10-01

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

40 CFR 265.228 - Closure and post-closure care.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 27 2012-07-01 2012-07-01 false Closure and post-closure care. 265.228... DISPOSAL FACILITIES Surface Impoundments § 265.228 Closure and post-closure care. (a) At closure, the owner... impoundment and provide post-closure care for a landfill under subpart G and § 265.310, including the...

40 CFR 265.228 - Closure and post-closure care.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 26 2011-07-01 2011-07-01 false Closure and post-closure care. 265.228... DISPOSAL FACILITIES Surface Impoundments § 265.228 Closure and post-closure care. (a) At closure, the owner... impoundment and provide post-closure care for a landfill under subpart G and § 265.310, including the...

Use of the Boomerang catalyst advantage closure device to facilitate complex multistaged percutaneous revascularization procedures for the treatment of critical limb ischemia.

PubMed

Garcia, Joel A; Casserly, Ivan P

2009-07-01

An increasing spectrum of complex peripheral arterial disease may be successfully treated using percutaneous revascularization techniques. A pair of challenging peripheral revascularization procedures in patients with critical limb ischemia is presented, where an array of interventional tools and techniques were required, and the off-label use of the Boomerang catalyst system closure device was important in managing a variety of complex arterial access issues and ultimately allowing procedural success. Copyright 2009 Wiley-Liss, Inc.

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

PubMed

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

2017-06-21

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

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.

Assessment of Device-Related Thrombus and Associated Clinical Outcomes With the WATCHMAN Left Atrial Appendage Closure Device for Embolic Protection in Patients With Atrial Fibrillation (from the PROTECT-AF Trial).

PubMed

Main, Michael L; Fan, Dali; Reddy, Vivek Y; Holmes, David R; Gordon, Nicole T; Coggins, Tina R; House, John A; Liao, Lawrence; Rabineau, Dawn; Latus, George G; Huber, Kenneth C; Sievert, Horst; Wright, Richard F; Doshi, Shephal K; Douglas, Pamela S

2016-04-01

Left atrial appendage closure with the WATCHMAN device is an alternative to anticoagulation for stroke prevention in selected patients with atrial fibrillation (AF). LA device-related thrombus (DRT) is poorly defined and understood. We aimed to (1) develop consensus echocardiographic diagnostic criteria for DRT; (2) estimate the incidence of DRT; and (3) determine clinical event rates in patients with DRT. In phase 1 (training), a training manual was developed and reviewed by 3 echocardiographers with left atrial appendage closure device experience. All available transesophageal (TEE) studies in the WATCHMAN left atrial appendage system for embolic protection in patients with atrial fibrillation (PROTECT-AF) trial patients with suspected DRT were reviewed in 2 subsequent phases. In phase 2 (primary blind read), each reviewer independently scored each study for DRT, and final echo criteria were developed. Unanimously scored studies were considered adjudicated, whereas all others were reevaluated by all reviewers in phase 3 (group adjudication read). DRT was suspected in 35 of 485 patients by the site investigator, the echocardiography core laboratory, or both; 93 of the individual TEE studies were available for review. In phase 2, 3 readers agreed on 67 (72%) of time points. Based on phases 1 and 2, 5 DRT criteria were developed. In phase 3, studies without agreement in phase 2 were adjudicated using these criteria. Overall, at least 1 TEE was DRT positive in 27 (5.7%) PROTECT-AF patients. Stroke, peripheral embolism, or cardiac/unexplained death occurred in subjects with DRT at a rate of 3.4 per 100 patient-years follow-up. In conclusion, DRT were identified on at least 1 TEE in 27 PROTECT-AF patients, indicating a DRT incidence of 5.7%. Primary efficacy events in patients with DRT occurred at a rate of 3.4 per 100 patient-years follow-up, intermediate in frequency between event rates previously reported for the overall device and warfarin arms in PROTECT

Catheter-based closure of the patent ductus arteriosus in lower weight infants.

PubMed

Pavlek, Leeann R; Slaughter, Jonathan L; Berman, Darren P; Backes, Carl H

2018-06-13

Risks associated with drug therapy and surgical ligation have led health care providers to consider alternative strategies for patent ductus arteriosus (PDA) closure. Catheter-based PDA closure is the procedure of choice for ductal closure in adults, children, and infants ≥6kg. Given evidence among older counterparts, interest in catheter-based closure of the PDA in lower weight (<6kg) infants is growing. Among these smaller infants, the goals of this review are to: (1) provide an overview of the procedure; (2) review the types of PDA closure devices; (3) review the technical success (feasibility); (4) review the risks (safety profile); (5) discuss the quality of evidence on procedural efficacy; (6) consider areas for future research. The review provided herein suggests that catheter-based PDA closure is technically feasible, but the lack of comparative trials precludes determination of the optimal strategy for ductal closure in this subgroup of infants. Copyright © 2018 Elsevier Inc. All rights reserved.

Trans-pulmonary echocardiography as a guide for device closure of patent ductus arteriosus.

PubMed

Kudo, Yoshiyuki; Suda, Kenji; Yoshimoto, Hironaga; Teramachi, Yozo; Kishimoto, Shintaro; Iemura, Motofumi; Matsuishi, Toyojiro

2015-08-01

The aim of this study was to develop trans-pulmonary echocardiography (TPE) to guide device closure of patent ductus arteriosus (DC-PDA). Aortography requires a large amount of contrast yet may give us an inadequate image to evaluate anatomy or residual shunt in patients with large PDA or dilated vessels and is precluded in patients with renal dysfunction. Practically, there is no imaging modality to monitor the entire procedure except for trans-esophageal echocardiography that requires general anesthesia. Subjects were seven patients with ages ranged from 6- to 77-years old and body weight > 15 kg. The size of the PDA ranged from 1.8 to 6.3 mm with pulmonary to systemic flow ratios from 1.2 to 2.2. During DC-PDA using Ampaltzer Duct Occluder or coil, an intra-cardiac echocardiographic (ICE) catheter was advanced into pulmonary arteries and standard views were developed to guide DC-PDA. We have developed two standard views; the main pulmonary artery view (MPA view) and the left pulmonary artery view (LPA view). The MPA view provided aortic short axis view equivalent to that seen by trans-thoracic echocardiography in children. The LPA view, obtained by the echo probe in the LPA and turned it up upside down, provided long axis view of the PDA allowing more precise anatomical evaluation. TPE allowed us to monitor the entire procedure and determine residual shunts. TPE in the MPA and LPA view can be an effective guide for DC-PDA. This report leads to new application of this imaging device. © 2015 Wiley Periodicals, Inc.

The Value of 3D Printing Models of Left Atrial Appendage Using Real-Time 3D Transesophageal Echocardiographic Data in Left Atrial Appendage Occlusion: Applications toward an Era of Truly Personalized Medicine.

PubMed

Liu, Peng; Liu, Rijing; Zhang, Yan; Liu, Yingfeng; Tang, Xiaoming; Cheng, Yanzhen

The objective of this study was to assess the clinical feasibility of generating 3D printing models of left atrial appendage (LAA) using real-time 3D transesophageal echocardiogram (TEE) data for preoperative reference of LAA occlusion. Percutaneous LAA occlusion can effectively prevent patients with atrial fibrillation from stroke. However, the anatomical structure of LAA is so complicated that adequate information of its structure is essential for successful LAA occlusion. Emerging 3D printing technology has the demonstrated potential to structure more accurately than conventional imaging modalities by creating tangible patient-specific models. Typically, 3D printing data sets are acquired from CT and MRI, which may involve intravenous contrast, sedation, and ionizing radiation. It has been reported that 3D models of LAA were successfully created by the data acquired from CT. However, 3D printing of the LAA using real-time 3D TEE data has not yet been explored. Acquisition of 3D transesophageal echocardiographic data from 8 patients with atrial fibrillation was performed using the Philips EPIQ7 ultrasound system. Raw echocardiographic image data were opened in Philips QLAB and converted to 'Cartesian DICOM' format and imported into Mimics® software to create 3D models of LAA, which were printed using a rubber-like material. The printed 3D models were then used for preoperative reference and procedural simulation in LAA occlusion. We successfully printed LAAs of 8 patients. Each LAA costs approximately CNY 800-1,000 and the total process takes 16-17 h. Seven of the 8 Watchman devices predicted by preprocedural 2D TEE images were of the same sizes as those placed in the real operation. Interestingly, 3D printing models were highly reflective of the shape and size of LAAs, and all device sizes predicted by the 3D printing model were fully consistent with those placed in the real operation. Also, the 3D printed model could predict operating difficulty and the

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.

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

PubMed Central

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

2018-01-01

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

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

2018-05-01

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.

Predictive Factors for Patients Undergoing ASD Device Occlusion Who "Crossover" to Surgery.

PubMed

Mulukutla, Venkatachalam; Qureshi, Athar M; Pignatelli, Ricardo; Ing, Frank F

2018-03-01

The aim of this study was to define characteristics of those patients who are referred for device closure of an Atrial septal defect (ASD), but identified to "crossover" surgery. All patients who underwent surgical and device (Amplatzer or Helex occluder) closures of secundum ASDs from 2001 to 2010 were reviewed and organized into three groups: surgical closure, device closure, and "crossover" group. 369 patients underwent ASD closure (265 device, 104 surgical). 42 of the 265 patients referred for device closure "crossed over" to the surgical group at various stages of the catheterization procedure. The device group had defect size measuring 14.2 mm (mean) and an ASD index (Defect Size (mm)/BSA) of 14.0 compared to the corresponding values in the surgical group (20.1 mm, ASD index 25.9) (P < 0.001) and in the "crossover" group (20.7 mm, 22.6 ASD index) (P < 0.001). 79 patients in the device group had a deficient rim, and 86% were located in the retroaortic region. 33 patients in the "crossover" group had deficient rims with 70% deficiency in the posterior/inferior rim. The device group with deficient rims had an ASD index of 14.7 compared with the crossover group ASD index of 23.8 (P < 0.001). Comparing the device and "crossover" groups, an ASD index greater than 23.7 had a 90% specificity in "crossing over" to surgery. The crossover and surgical groups had statistically larger ASD defect size indexes compared with the device group. Deficient rim in the posterior/inferior rim is associated with a large ASD size index which is a predictive factor for crossing over to surgery. Catheterization did not negatively impact surgical results in the "crossover" group.

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

PubMed

Ali, Safaa; El Sisi, Amel

2016-04-01

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

Percutaneous patent foramen ovale closure: the Paradoxical Cerebral Embolism Prevention Registry.

PubMed

Paiva, Luís; Dinis, Paulo; Providência, Rui; Costa, Marco; Margalho, Susana; Goncalves, Lino

2015-03-01

The natural history and therapeutic interventions for secondary prevention after a cerebrovascular event in patients with patent foramen ovale (PFO) are not yet established. This study aims to assess the safety and efficacy of percutaneous PFO closure in a population of patients with ischemic cerebrovascular disease of unknown etiology. This prospective observational study included patients with a history of cryptogenic transient ischemic attack (TIA) or stroke who underwent percutaneous PFO closure. The effectiveness of the device for the secondary prevention of TIA or stroke was assessed by comparing observed events in the sample with expected events for this clinical setting. The sample included 193 cases of percutaneous PFO closure (age 46.4 ± 13.1 years, 62.2% female) with a mean follow-up of 4.3 ± 2.2 years, corresponding to a total exposure to ischemic events of 542 patient-years. The high-risk characteristics of the PFO were assessed prior to device implantation. There were seven primary endpoint events during follow-up (1.3 per 100 patient-years), corresponding to a relative risk reduction of 68.2% in recurrent TIA or stroke compared to medical therapy alone. The procedure was associated with a low rate of device- or intervention-related complications (1.5%). In this long-term registry, percutaneous PFO closure was shown to be a safe and effective therapy for the secondary prevention of cryptogenic stroke or TIA. Copyright © 2014 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

Prevalence of patent foramen ovale and usefulness of percutaneous closure device in carcinoid heart disease.

PubMed

Mansencal, Nicolas; Mitry, Emmanuel; Pillière, Rémy; Lepère, Céline; Gérardin, Benoît; Petit, Jérôme; Gandjbakhch, Iradj; Rougier, Philippe; Dubourg, Olivier

2008-04-01

The aim of this study was to assess (1) the incidence of patent foramen ovale (PFO) in carcinoid syndrome (CS) and (2) the feasibility of percutaneous closure procedure in selected patients with CS. One hundred eight patients were prospectively studied: 54 with CS and an age- and gender-matched control group. All patients underwent conventional and contrast echocardiography. Patients with clinical signs of dyspnea (New York Heart Association class > or =III), cyanosis, carcinoid heart disease (CHD), and severe PFO were referred for the percutaneous closure of PFO. The prevalence of PFO was 41% in patients with CS and 22% in the control group (p = 0.03) and was significantly higher in patients with CHD (59%, p = 0.009). Four patients (14% of those with CHD) were referred for the percutaneous closure of PFO, and 3 patients ultimately underwent PFO closure (using Amplatzer septal occluders). At 6-month follow-up, New York Heart Association class was improved in all patients, as well as arterial blood gas results (p = 0.04) and 6-minute walking distance (p = 0.03), but all patients presented residual right-to-left shunts. In conclusion, this prospective study demonstrates that in patients with CHD, the prevalence of PFO is high and that percutaneous closure of PFO is feasible, with a reduction in symptoms but with residual shunting.

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

The left atrial appendage: from embryology to prevention of thromboembolism.

PubMed

Patti, Giuseppe; Pengo, Vittorio; Marcucci, Rossella; Cirillo, Plinio; Renda, Giulia; Santilli, Francesca; Calabrò, Paolo; De Caterina, Alberto Ranieri; Cavallari, Ilaria; Ricottini, Elisabetta; Parato, Vito Maurizio; Zoppellaro, Giacomo; Di Gioia, Giuseppe; Sedati, Pietro; Cicchitti, Vincenzo; Davì, Giovanni; Golia, Enrica; Pariggiano, Ivana; Simeone, Paola; Abbate, Rosanna; Prisco, Domenico; Zimarino, Marco; Sofi, Francesco; Andreotti, Felicita; De Caterina, Raffaele

2017-03-21

The left atrial appendage (LAA) is the main source of thromboembolism in patients with non-valvular atrial fibrillation (AF). As such, the LAA can be the target of specific occluding device therapies. Optimal management of patients with AF includes a comprehensive knowledge of the many aspects related to LAA structure and thrombosis. Here we provide baseline notions on the anatomy and function of the LAA, and then focus on current imaging tools for the identification of anatomical varieties. We also describe pathogenetic mechanisms of LAA thrombosis in AF patients, and examine the available evidence on treatment strategies for LAA thrombosis, including the use of non-vitamin K antagonist oral anticoagulants and interventional approaches. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

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

No evidence that manual closure of the bronchial stump has a lower failure rate than mechanical stapler closure following anatomical lung resection.

PubMed

Zakkar, Mustafa; Kanagasabay, Robin; Hunt, Ian

2014-04-01

A best evidence topic in cardiothoracic surgery was written according to a structured protocol. The question addressed was whether manual closure of the bronchial stump is safer with lower failure rates than mechanical closure using a stapling device following anatomical lung resection. One hundred and twenty-nine papers were identified using the search below. Eight papers presented the best evidence to answer the clinical question as they included sufficient number of patients to reach conclusions regarding the issues of interest for this review. Complications, complication rates and operation time were included in the assessment. The author, journal, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of the papers are tabulated. When looking at manual vs mechanical staples, it was noted that stapler failure can occur in around 4% of cases. The rate of bronchopleural fistula (BPF) development varied more in patients who underwent manual closure (1.5-12.5%) than in patients who underwent mechanical closure (1-5.7%). Although most of the studies reviewed showed no statistical differences between manual and mechanical closure in terms of BPF development, one study, however, showed that manual closure was significantly associated with lower numbers of postoperative BPF, while another study showed that mechanical closure is significantly associated with lower incidence of BPF. When looking at the role of the learning curve and training opportunities, it seems that the surgeon's inexperience when using mechanical staples can contribute to BPF development. A surgeon's experience can play a major role in the prevention of BPF development in patients having manual closure. Manual closure can provide a cheap and reliable technique when compared with costs incurred from using staplers, it is applicable in all situations and can be taught to surgeons in training with an acceptable risk. However, there is a lack

No evidence that manual closure of the bronchial stump has a lower failure rate than mechanical stapler closure following anatomical lung resection

PubMed Central

Zakkar, Mustafa; Kanagasabay, Robin; Hunt, Ian

2014-01-01

A best evidence topic in cardiothoracic surgery was written according to a structured protocol. The question addressed was whether manual closure of the bronchial stump is safer with lower failure rates than mechanical closure using a stapling device following anatomical lung resection. One hundred and twenty-nine papers were identified using the search below. Eight papers presented the best evidence to answer the clinical question as they included sufficient number of patients to reach conclusions regarding the issues of interest for this review. Complications, complication rates and operation time were included in the assessment. The author, journal, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of the papers are tabulated. When looking at manual vs mechanical staples, it was noted that stapler failure can occur in around 4% of cases. The rate of bronchopleural fistula (BPF) development varied more in patients who underwent manual closure (1.5–12.5%) than in patients who underwent mechanical closure (1–5.7%). Although most of the studies reviewed showed no statistical differences between manual and mechanical closure in terms of BPF development, one study, however, showed that manual closure was significantly associated with lower numbers of postoperative BPF, while another study showed that mechanical closure is significantly associated with lower incidence of BPF. When looking at the role of the learning curve and training opportunities, it seems that the surgeon's inexperience when using mechanical staples can contribute to BPF development. A surgeon's experience can play a major role in the prevention of BPF development in patients having manual closure. Manual closure can provide a cheap and reliable technique when compared with costs incurred from using staplers, it is applicable in all situations and can be taught to surgeons in training with an acceptable risk. However, there is a

Transcatheter device closure of pseudoaneurysms of the left ventricular wall: An emerging therapeutic option.

PubMed

Madan, Tarun; Juneja, Manish; Raval, Abhishek; Thakkar, Bhavesh

2016-02-01

Left ventricular pseudoaneurysm is a rare but serious complication of acute myocardial infarction and cardiac surgery. While surgical intervention is the conventional therapeutic option, transcatheter closure can be considered in selected patients with suitable morphology of the pseudoaneurysm. We report a case of successful transcatheter closure of a left ventricular pseudoaneurysm orifice and isolation of the sac using an Amplatzer septal occluder. Copyright © 2016 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

Direct Percutaneous Left Ventricular Access and Port Closure

PubMed Central

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

2012-01-01

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

40 CFR 264.258 - Closure and post-closure care.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Waste Piles § 264.258 Closure and post-closure care. (a) At closure, the owner or operator must remove... that apply to landfills (§ 264.310). (c)(1) The owner or operator of a waste pile that does not comply...(c) or § 264.251(b), must: (i) Include in the closure plan for the pile under § 264.112 both a plan...

A Quick Guide to Paravalvular Leak Closure

PubMed Central

Gafoor, Sameer; Franke, Jennifer; Bertog, Stefan; Lam, Simon; Vaskelyte, Laura; Hofmann, Ilona; Matic, Predrag

2015-01-01

Paravalvular leak (PVL) is a seldomly covered aspect of structural heart disease. However, this is a condition that frequently presents after valvular replacement. This article will cover the diagnosising and treating PVL (i.e. imaging, access, and device selection). In addition, specific aspects of aortic and mitral PVL closure will be covered in this review. PMID:29588686

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

PubMed Central

Ali, Safaa; El Sisi, Amel

2015-01-01

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

Transcatheter closure of Patent Ductus Arteriosus through only venous route.

PubMed

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

2018-03-01

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

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.

Intracardiac Echocardiography for Structural Heart and Electrophysiological Interventions.

PubMed

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

2017-09-06

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

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

PubMed

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

2013-12-11

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

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

PubMed

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

2018-04-03

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

Evaluating the morphology of the left atrial appendage by a transesophageal echocardiographic 3-dimensional printed model

PubMed Central

Song, Hongning; Zhou, Qing; Zhang, Lan; Deng, Qing; Wang, Yijia; Hu, Bo; Tan, Tuantuan; Chen, Jinling; Pan, Yiteng; He, Fazhi

2017-01-01

Abstract The novel 3-dimensional printing (3DP) technique has shown its ability to assist personalized cardiac intervention therapy. This study aimed to determine the feasibility of 3D-printed left atrial appendage (LAA) models based on 3D transesophageal echocardiography (3D TEE) data and their application value in treating LAA occlusions. Eighteen patients with transcatheter LAA occlusion, and preprocedure 3D TEE and cardiac computed tomography were enrolled. 3D TEE volumetric data of the LAA were acquired and postprocessed for 3DP. Two types of 3D models of the LAA (ie, hard chamber model and flexible wall model) were printed by a 3D printer. The morphological classification and lobe identification of the LAA were assessed by the 3D chamber model, and LAA dimensions were measured via the 3D wall model. Additionally, a simulation operative rehearsal was performed on the 3D models in cases of challenging LAA morphology for the purpose of understanding the interactions between the device and the model. Three-dimensional TEE volumetric data of the LAA were successfully reprocessed and printed as 3D LAA chamber models and 3D LAA wall models in all patients. The consistency of the morphological classifications of the LAA based on 3D models and cardiac computed tomography was 0.92 (P < .01). The differences between the LAA ostium dimensions and depth measured using the 3D models were not significant from those measured on 3D TEE (P > .05). A simulation occlusion was successfully performed on the 3D model of the 2 challenging cases and compared with the real procedure. The echocardiographic 3DP technique is feasible and accurate in reflecting the spatial morphology of the LAA, which may be promising for the personalized planning of transcatheter LAA occlusion. PMID:28930824

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

Vacuum assisted closure for the treatment of sternal wounds: the bridge between débridement and definitive closure.

PubMed

Song, David H; Wu, Liza C; Lohman, Robert F; Gottlieb, Lawrence J; Franczyk, Mieczyslawa

2003-01-01

A method to refine the treatment of sternal wounds using Vacuum Assisted Closure (V.A.C.) therapy as the bridge between débridement and delayed definitive closure is described. A retrospective review of 35 consecutive patients with sternal wound complications over a 2-year period (March of 1999 to March of 2001) was performed. The treatment of sternal wounds with traditional twice-a-day dressing changes was compared with the treatment with the wound V.A.C. device. An analysis of the number of days between initial débridement and closure, number of dressing changes, number and types of flaps needed for reconstruction, and complications was performed. Eighteen patients were treated with traditional twice-a-day dressing changes and 17 patients were treated with V.A.C. therapy alone. The two groups were similar regarding age, sex, type of cardiac procedure, and type of sternal wound. The V.A.C. therapy group had a trend toward a shorter interval between débridement and closure, with a mean of 6.2 days, whereas the dressing change group had mean of 8.5 days. The V.A.C. therapy group had a significantly lower number of dressing changes, with a mean of three, whereas the twice-a-day dressing change group had a mean of 17 (p < 0.05). Reconstruction required an average of 1.5 soft-tissue flaps per patient treated with traditional dressing changes versus 0.9 soft-tissue flaps per patient for those treated with V.A.C. therapy (p < 0.05). Before closure, there was one death among patients undergoing dressing changes and three in the V.A.C. therapy group, all of which were unrelated to the management of the sternal wound. Patients with sternal wounds who have benefited from V.A.C. therapy alone have a significant decrease in the number of dressing changes and number of soft-tissue flaps needed for closure. Finally, the V.A.C. therapy group had a trend toward a decreased number of days between débridement and closure.

Microvascular anastomosis using the vascular closure device in free flap reconstructive surgery: A 13-year experience.

PubMed

Reddy, Chaitan; Pennington, David; Stern, Harvey

2012-02-01

The achievement of patency of the microvascular anastomosis in free flap surgery is dependent on a number of factors, central to which is atraumatic handling of the vessel lumen, and intimal apposition. Initial laboratory studies demonstrating the superiority of the non-penetrating vascular closure staple (VCS - Anastoclip ®) were followed by our report in 1999 on a series of free flaps. There is still a paucity of data in the literature on the use of non-penetrating devices for microvascular anastomosis, and our review gives evidence to support the routine use of the VCS in microsurgical free flap surgery. We now report on its successful use over a thirteen year period in 819 free flap reconstructions. Our data indicates the VCS device to be as effective as sutured anastomoses in free tissue transfer surgery. There is also statistically significant data (Barnard's Exact Test) to demonstrate a higher vascular patency rate of the VCS device over sutured anastomoses when sub group analysis is performed. 'Take-back' revision rates were lower amongst flaps that employed VCS use. For arterial anastomoses, this equated to 3/654(0.05%) vs 4/170(2.4%) with hand-sewn anastomoses (p = 0.02). Similarly, for venous anastomoses the 'take-back' revision rate was 7/661(1.1%) vs 8/165(4.8%) with hand-sewn anastomoses (p = 0.003). Furthermore, the major advantage of the VCS is reduction in anastomosis time, from approximately 25 min per anastomosis for sutures to between five and 10 min for staples. Copyright © 2011 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

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

40 CFR 264.280 - Closure and post-closure care.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Section 264.280 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES Land Treatment § 264.280 Closure and post-closure care. (a) During the closure period the owner or...

40 CFR 264.280 - Closure and post-closure care.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Section 264.280 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES Land Treatment § 264.280 Closure and post-closure care. (a) During the closure period the owner or...

40 CFR 264.280 - Closure and post-closure care.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Section 264.280 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES Land Treatment § 264.280 Closure and post-closure care. (a) During the closure period the owner or...

40 CFR 264.280 - Closure and post-closure care.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Section 264.280 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES Land Treatment § 264.280 Closure and post-closure care. (a) During the closure period the owner or...

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

PubMed

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

2014-01-01

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

Percutaneous closure of hypertensive ductus arteriosus.

PubMed

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

2010-04-01

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

Patent Ductus Arteriosus closure in preterms less than 2kg: Surgery versus transcatheter.

PubMed

Pamukcu, Ozge; Tuncay, Aydin; Narin, Nazmi; Baykan, Ali; Korkmaz, Levent; Argun, Mustafa; Ozyurt, Abdullah; Sunkak, Suleyman; Uzum, Kazim

2018-01-01

As new devices come into the market, percutaneous techniques improve and interventionalists become more experienced; percutaneous closure gets more common in preterms. In this study we aimed to compare efficacy and safety of Patent Ductus Arteriosus closure surgically versus transcatheter method in preterms <2kg. Best of our knowledge this study is the first one that compares outcomes of surgery and percutaneous Patent Ductus Arteriosus closure in preterms. Between the dates July 1997 to October 2014 in our center Patent Ductus Arteriosus of 26 patients <2kg were closed percutaneously (Group A) and 31 less than 2kg operated (Group B). Weight of patients in percutaneous Patent Ductus Arteriosus closure group was significantly more than the surgery group. Mean gestational age of the patients in Group A was 30±1.8weeks, in group B was 28.6±3.5weeks. In group A; all cases were closed successfully except 4 cases: device embolization in 2, cardiac tamponade and iatrogenic aortic coarctation were seen. Pneumomediastinum and chylothorax were the major complications of the surgery group. There was no statistically significance between complication and success rates between two groups. Percutaneous Patent Ductus Arteriosus closure is the candidate for taking the place of surgery in preterms. However, it is not applied routinely; can only be done in fully equipped large centers by experienced interventionalists. Copyright © 2017 Elsevier B.V. All rights reserved.

40 CFR 265.1202 - Closure and post-closure care.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 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, after...

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

PubMed

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

2018-04-03

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

The open abdomen and temporary abdominal closure systems--historical evolution and systematic review.

PubMed

Quyn, A J; Johnston, C; Hall, D; Chambers, A; Arapova, N; Ogston, S; Amin, A I

2012-08-01

Several techniques for temporary abdominal closure have been developed. We systematically review the literature on temporary abdominal closure to ascertain whether the method can be tailored to the indication. Medline, Embase, the Cochrane Central Register of Controlled Trials and relevant meeting abstracts until December 2009 were searched using the following headings: open abdomen, laparostomy, VAC (vacuum assisted closure), TNP (topical negative pressure), fascial closure, temporary abdominal closure, fascial dehiscence and deep wound dehiscence. The data were analysed by closure technique and aetiology. The primary end-points included delayed fascial closure and in-hospital mortality. The secondary end-points were intra-abdominal complications. The search identified 106 papers for inclusion. The techniques described were VAC (38 series), mesh/sheet (30 series), packing (15 series), Wittmann patch (eight series), Bogotá bag (six series), dynamic retention sutures (three series), zipper (15 series), skin only and locking device (one series each). The highest facial closure rates were seen with the Wittmann patch (78%), dynamic retention sutures (71%) and VAC (61%). Temporary abdominal closure has evolved from simple packing to VAC based systems. In the absence of sepsis Wittmann patch and VAC offered the best outcome. In its presence VAC had the highest delayed primary closure and the lowest mortality rates. However, due to data heterogeneity only limited conclusions can be drawn from this analysis. © 2012 The Authors. Colorectal Disease © 2012 The Association of Coloproctology of Great Britain and Ireland.

Closure of tubular patent ductus arteriosus with the Amplatzer Vascular Plug IV: feasibility and safety.

PubMed

Baruteau, Alban-Elouen; Lambert, Virginie; Riou, Jean-Yves; Angel, Claude-Yves; Belli, Emre; Petit, Jérôme

2015-01-01

Closure of tubular patent ductus arteriosus remains a challenging procedure. Anecdotal use of Amplatzer Vascular Plug IV for tubular ductus closure has been reported but feasibility and safety in a consecutive patients' series remain unknown. We performed a monocenter prospective study at the Marie Lannelongue Hospital in Paris, France. From 2009 to 2014, a total of 47 patients (39 infants, 3 children, and 5 adults) underwent ductus closure with the Plug IV. Ductus morphology was a type E in 34 (72.3%) patients and a type C in 13 (27.7%) patients. Ductus closure occurred in 39 (83.0%) infants at a median age of seven months (range: 3-23 months) and a median weight of 6.9 kg (range: 4.1-17.0 kg). A past history of prematurity and very low birth weight was found in 33 (70.2%) of them. Twelve (25.5%) patients had pulmonary hypertension. Mean Plug IV diameter was 1.9 ± 0.1 mm larger than the mean maximal ductus diameter. Early complete closure of the ductus was obtained in all patients. Early migration of an undersized Plug IV occurred in one (2.1%) patient and was suitable for percutaneous device retrieval. After a mean follow-up of 3.4 ± 1.4 years, all patients are alive and asymptomatic, no late complication occurred. Transcatheter closure of tubular ductus with the Amplatzer Vascular Plug IV can be safe and effective, with a 100% early occlusion rate. This device, suitable for a 4F sheath, is a new alternative for tubular ductus closure in low-body-weight infants. © The Author(s) 2014.

Closure of colostomy.

PubMed Central

Beck, P H; Conklin, H B

1975-01-01

We analyzed the records of 77 cases of loop colostomy closure in Vietnam War Casualties. All records were complete from the date of injury to discharge following colostomy closure. Simple of the loop colostomy was performed in 44 patients and resection of the stoma and reanastomosis of bowel segments was performed in 33 patients. Average operating time for simple closure of the loop was 70 minutes compared to 115 minutes for resection and anastomosis. Nasogastric suction was used less frequently and for a shorter time with simple loop closure. The total postoperative complication rate was 9% with simple loop closure as compared to 24% for resection and anastomosis. Simple closure of the loop described in this report is technically easier and as safe as resection of the stoma and reanastomosis. Images Fig. 1. PMID:1094967

Thrombophilia-Related Complications in the Treatment of a Left Atrial Appendage Thrombus: A Case Report

PubMed Central

Parato, Vito Maurizio; Scarano, Michele; Labanti, Benedetto

2014-01-01

Trans-esophageal echocardiography (TEE) revealed a left atrial appendage (LAA) thrombus in an 84-year-old woman with nonvalvular atrial fibrillation not known before our evaluation. In her medical history, there were hypertension, dyslipidemia and a previous pulmonary embolism. She was taking warfarin at time of our evaluation and presented signs and symptoms of heart failure. Together with heart failure treatment, intravenous anticoagulation with unfractionated heparin was initiated. Treatment was complicated by additional right lower limb embolic event and the LAA thrombus remained unchanged. Testing revealed heterozygosity for both the factor V Leiden and the methylenetetrahydrofolate reductase C677T mutations inducing resistance to activated protein C. The patient refused transcatheter closure of the left atrial appendage. PMID:28465906

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.

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

PubMed

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

2018-05-04

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

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

PubMed

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

2013-12-18

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

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

PubMed

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

2015-01-01

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

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

PubMed

Garg, Gaurav; Garg, Vishal; Prakash, Amit

2018-03-01

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

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

PubMed

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

2015-02-01

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

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.

Interferometric Imaging Directly with Closure Phases and Closure Amplitudes

NASA Astrophysics Data System (ADS)

Chael, Andrew A.; Johnson, Michael D.; Bouman, Katherine L.; Blackburn, Lindy L.; Akiyama, Kazunori; Narayan, Ramesh

2018-04-01

Interferometric imaging now achieves angular resolutions as fine as ∼10 μas, probing scales that are inaccessible to single telescopes. Traditional synthesis imaging methods require calibrated visibilities; however, interferometric calibration is challenging, especially at high frequencies. Nevertheless, most studies present only a single image of their data after a process of “self-calibration,” an iterative procedure where the initial image and calibration assumptions can significantly influence the final image. We present a method for efficient interferometric imaging directly using only closure amplitudes and closure phases, which are immune to station-based calibration errors. Closure-only imaging provides results that are as noncommittal as possible and allows for reconstructing an image independently from separate amplitude and phase self-calibration. While closure-only imaging eliminates some image information (e.g., the total image flux density and the image centroid), this information can be recovered through a small number of additional constraints. We demonstrate that closure-only imaging can produce high-fidelity results, even for sparse arrays such as the Event Horizon Telescope, and that the resulting images are independent of the level of systematic amplitude error. We apply closure imaging to VLBA and ALMA data and show that it is capable of matching or exceeding the performance of traditional self-calibration and CLEAN for these data sets.

Same-day discharge after coronary stenting and femoral artery device closure: A randomized study in stable and low-risk acute coronary syndrome patients.

PubMed

Clavijo, Leonardo C; Cortes, Guillermo A; Jolly, Aaron; Tun, Han; Mehra, Anilkumar; Gaglia, Michael A; Shavelle, David; Matthews, Ray V

2016-01-01

To compare same-day (SD) vs. delayed hospital discharge (DD) after single and multivessel coronary stenting facilitated by femoral closure device in patients with stable angina and low-risk acute coronary syndrome (ACS). University of Southern California patients were screened and coronary stenting was performed in 2480 patients. Four hundred ninety-three patients met screening criteria and consented. Four hours after percutaneous coronary intervention, 100 were randomized to SD (n=50) or DD (n=50). Patients were followed for one year; outcomes-, patient satisfaction-, and cost analyses were performed. Groups were well distributed, with similar baseline demographic and angiographic characteristics. Mean age was 58.1±8.8years and 86% were male. Non-ST-elevation myocardial infarction and unstable angina were the clinical presentations in 30% and 44% of the SD and DD groups, respectively (p=0.2). Multivessel stenting was performed in 36% and 30% of SD and DD groups, respectively (p=0.14). At one year, two patients from each group (4%) required unplanned revascularization and one patient in the SD group had a gastrointestinal bleed that required a blood transfusion. Six SD and four DD patients required repeat hospitalization (p=0.74). There were no femoral artery vascular complications in either group. Patient satisfaction scores were equivalent. SD discharge was associated with $1200 savings per patient. SD discharge after uncomplicated single and multivessel coronary stenting of patients with stable, low-risk ACS, via the femoral approach facilitated by a closure device, is associated with similar clinical outcomes, patient satisfaction, and cost savings compared to overnight (DD) hospital stay. Copyright © 2016 Elsevier Inc. All rights reserved.

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

PubMed

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

2010-12-01

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

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

PubMed

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

2013-08-01

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

Device for temporarily closing duct-formers in well completion apparatus

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

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

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

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

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

Rimon, Uri, E-mail: rimonu@sheba.health.gov.il; Khaitovich, Boris, E-mail: borislena@012.net.il; Yakubovich, Dmitry, E-mail: Dmitry.Yakubovitch@sheba.health.gov.il

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 ExoSealmore » 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 %)« less

40 CFR 264.1202 - Closure and post-closure care.

Code of Federal Regulations, 2014 CFR

2014-07-01

... FACILITIES Hazardous Waste Munitions and Explosives Storage § 264.1202 Closure and post-closure care. (a) At... it remains in service as a munitions or explosives magazine or storage unit. (b) If, after removing...

40 CFR 264.1202 - Closure and post-closure care.

Code of Federal Regulations, 2011 CFR

2011-07-01

... FACILITIES Hazardous Waste Munitions and Explosives Storage § 264.1202 Closure and post-closure care. (a) At... it remains in service as a munitions or explosives magazine or storage unit. (b) If, after removing...

40 CFR 264.1202 - Closure and post-closure care.

Code of Federal Regulations, 2013 CFR

2013-07-01

... FACILITIES Hazardous Waste Munitions and Explosives Storage § 264.1202 Closure and post-closure care. (a) At... it remains in service as a munitions or explosives magazine or storage unit. (b) If, after removing...

40 CFR 264.1202 - Closure and post-closure care.

Code of Federal Regulations, 2012 CFR

2012-07-01

... FACILITIES Hazardous Waste Munitions and Explosives Storage § 264.1202 Closure and post-closure care. (a) At... it remains in service as a munitions or explosives magazine or storage unit. (b) If, after removing...

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

PubMed Central

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

2015-01-01

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

46 CFR 151.15-10 - Cargo gauging devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... contains definitions and requirements for types of gauging devices specified in Table 151.05. (a) Open... the cargo and its vapors. Examples of this type are gauge hatch, ullage hole. (b) Restricted. A... closure device in that opening. When not in use, this type gauging device is closed to maintain the...

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.

Loop-anchor purse-string closure of gastrotomy in NOTES(R) procedures: survival studies in a porcine model.

PubMed

Romanelli, John R; Desilets, David J; Chapman, Christopher N; Surti, Vihar C; Lovewell, Carolanne; Earle, David B

2010-12-01

Transgastric NOTES(®) procedures remain without a simple method to close the gastrotomy. In four survival swine studies, we have tested a novel gastric closure device: the loop-anchor purse-string (LAPS) closure system. In four anesthetized pigs, an endoscopic gastrotomy was performed. Four loop anchors were arrayed in a 2-cm square pattern around the gastrotomy. The endoscope was passed into the abdominal cavity, and the gastrotomy was cinched closed. Procedure times ranged from 50-180 minutes. Three pigs survived 14 days. One animal was sacrificed early due to signs of sepsis. Another animal developed fevers and was treated with antibiotics. At necropsy, there were no abscesses, including in the septic animal. Histologic examination revealed evidence of healing in all animals. The LAPS system holds promise with early success in an animal model. Future human studies are needed to determine viability as a human visceral closure device.

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.

Gestalt concept of closure: a construct without closure.

PubMed

Wasserstein, Jeanette

2002-12-01

This comment reviews the original Gestalt literature which introduced the concept of 'closure'. It is argued that the meaning of 'closure' was confounded in the source literature and, thus, the term connotes more than it denotes. Research based on different measures of this ambiguous construct inevitably may not always converge.

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.

Vacuum-assisted closure device as a split-thickness skin graft bolster in the burn population.

PubMed

Waltzman, Joshua T; Bell, Derek E

2014-01-01

The vacuum-assisted closure device (VAC) is associated with improved wound healing outcomes. Its use as a bolster device to secure a split-thickness skin graft has been previously demonstrated; however, there is little published evidence demonstrating its benefits specifically in the burn population. With use of the VAC becoming more commonplace, its effect on skin graft take and overall time to healing in burn patients deserves further investigation. Retrospective review of burn registry database at a high-volume level I trauma center and regional burn center during a 16-month period was performed. Patients who had a third-degree burn injury requiring a split-thickness skin graft and who received a VAC bolster were included. Data points included age, sex, burn mechanism, burn location, grafted area in square centimeters, need for repeat grafting, percent graft take, and time to complete reepithelialization. Sixty-seven patients were included in the study with a total of 88 skin graft sites secured with a VAC. Age ranged from <1 year to 84 years (average 41 years). The average grafted area was 367 ± 545 cm. The three most common were the leg, thigh, and arm (28, 15, and 12%, respectively). Average percent graft take was 99.5 ± 1.5%. Notably, no patients returned to the operating room for repeat grafting. The average time to complete reepithelialization was 16 ± 7 days. The VAC is a highly reliable and reproducible method to bolster a split-thickness skin graft in the burn population. The observed rate of zero returns to the operating room for repeat grafting was especially encouraging. Its ability to conform to contours of the body and cover large surface areas makes it especially useful in securing a graft. This method of bolstering results in decreased repeat grafting and minimal graft loss, thus decreasing morbidity compared with conventional bolster dressings.

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

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

Patel, Rafiuddin, E-mail: rafiuddin.patel@ouh.nhs.uk; Juszczak, Maciej T.; Bratby, Mark J.

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 sitesmore » 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.« less

40 CFR 264.197 - Closure and post-closure care.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Section 264.197 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES... as hazardous waste, unless § 261.3(d) of this chapter applies. The closure plan, closure activities...

[Recent and upcoming randomized trials for left atrial appendage occlusion : Need for a definite assessment of the situation].

PubMed

Skurk, Carsten; Hartung, Johannes Jakob; Landmesser, Ulf

2017-12-01

Atrial fibrillation (AF) is the most common arrhythmia affecting more than 1.6 million patients in Germany. Based on demographic developments, an the number is expected to increase. Embolic strokes in AF patients are particularly severe, and individualized new oral anticoagulant (NOAC) therapy reduces the incidence of stroke in these patients by approximately 70%. Besides vitamin K antagonists, the NOACs rivaroxaban, dabigatran, apixaban, and edoxaban have been introduced into clinical practice; however, major bleeding still occurs at a rate of 2-3% per year. Moreover, randomized studies and real-life registries suggest that >20% of patients with AF and an indication for anticoagulation cannot tolerate chronic oral anticoagulant therapy. Therefore, an alternative method for stroke prevention in AF patients has been developed, i. e., catheter-based exclusion of the left atrial appendage (LAA), a location that is prone for thrombus formation in these patients. The randomized trials of catheter-based LAA occlusion have compared this interventional therapy with vitamin K antagonists. In the future, however, LAA exclusion needs to be compared with NOAC therapy. Moreover, percutaneous LAA exclusion in clinical practice is mostly offered to patients ineligible for long-term oral anticoagulation or with high bleeding risk. However, no controlled, randomized trial data exist for this patient population. These data are needed for appropriate clinical judgment and optimal clinical management. Ongoing studies and scientific questions that are important to define the future for catheter-based LAA closure are discussed in this review.

Transcatheter closure of patent ductus arteriosus: 11 years of clinical experience in Cipto Mangunkusumo Hospital, Jakarta, Indonesia.

PubMed

Djer, Mulyadi M; Saputro, Dimas Dwi; Putra, Sukman Tulus; Idris, Nikmah Salamia

2015-06-01

Transcatheter closure of patent ductus arteriosus (PDA) has been suggested to be the standard treatment of PDA. Although, in general, the procedure shows a high successful rate, outcomes may vary among pediatric cardiology centers. To evaluate the effectiveness of transcatheter closure of PDA in Cipto Mangunkusumo Hospital, Jakarta, Indonesia, this was a retrospective study on patients who underwent transcatheter closure of PDA in Cipto Mangunkusumo Hospital during the period of 2002-2013. Hospital registry was reviewed and data about patients' characteristics, PDA severity, procedure, and outcomes were retrieved. There were 298 patients, of whom 90 were males, who underwent transcatheter closure of PDA during the study period. Median age was 3.4 years (1 months-18 years), and median body weight was 12 (3.6-59) kg. The diameter of PDA ranged from 1.1 to 15.4 mm with a median of 3.7 mm. Device could be deployed in all patients, in which most were the Amplatzer ductal occluder (69.8 %) and the remainders were coils. Median fluoroscopy time was 15.4 (1.5-87) min, and procedure time was 76 (30-200) min. Complete closure was achieved in most patients (97.3 %), whereas device migration occurred in a minority (0.3 %) of patients. No major complication occurred during or after the procedure. Transient anemia and bradycardia were found in 3.7 and 1.3 % patients, respectively. Most patients were discharged from the hospital at 1 day after the procedure. Transcatheter closure method is a safe and effective procedure to close PDA.

Vitamin-C delivery from CoCr alloy surfaces using polymer-free and polymer-based platforms for cardiovascular stent applications.

PubMed

Thiruppathi, Eagappanath; Mani, Gopinath

2014-06-03

Antiproliferative drugs such as paclitaxel and sirolimus are delivered from stents to inhibit the growth of smooth muscle cells (SMCs) for preventing neointimal hyperplasia. However, these drugs delay the growth of endothelial cells (ECs) as well and cause late stent thrombosis. We recently demonstrated the use of Vitamin-C (l-ascorbic acid, l-AA) over paclitaxel and sirolimus for inhibiting SMCs growth and promoting EC growth simultaneously. In this study, we have investigated the delivery of l-AA from CoCr alloy surfaces for potential use in stents. A polymer-free phosphoric acid (PA) platform and a polymer-based poly(lactic-co-glycolic acid) (PLGA) platform were used for coating l-AA onto CoCr surfaces. For the PA platform, FTIR confirmed that the PA was coated on CoCr, while the AFM showed that the PA coating on the CoCr surface was homogeneous. The successful deposition of l-AA on PA-coated CoCr was also confirmed by FTIR. The uniform distribution of l-AA crystals on PA-coated CoCr was shown by SEM, optical profilometer, and AFM. The drug release studies showed that l-AA (276 μg/cm(2)) was burst released from the PA platform by 1 h. For the PLGA platform, SEM showed that the l-AA incorporated polymer films were smoothly and uniformly coated on CoCr. FTIR showed that l-AA was incorporated into the bulk of the PLGA film. DSC showed that the l-AA was present in an amorphous form and formed an intermolecular bonding interaction with PLGA. The drug release studies showed that l-AA was sustained released from the PLGA coated CoCr for up to 24 h. The SEM, FTIR, and DSC characterizations of samples collected post drug release shed light on the mechanism of l-AA release from PLGA coated CoCr. Thus, this study demonstrated the delivery of l-AA from biomaterial surfaces for potential applications in stents and other implantable medical devices.

New laser soldering-based closures: a promising method in natural orifice transluminal endoscopic surgery.

PubMed

Bogni, Serge; Ortner, Maria-Anna; Vajtai, Istvan; Jost, Christian; Reinert, Michael; Dallemagne, Bernard; Frenz, Martin

2012-07-01

Complete closure of gastrotomy is the linchpin of safe natural orifice transgastric endoscopic surgery. To evaluate feasibility and efficacy of a new method of gastrotomy closure by using a sutureless laser tissue-soldering (LTS) technique in an ex vivo porcine stomach. In vitro experiment. Experimental laboratory. Histological analysis and internal and external liquid pressure with and without hydrochloric acid exposure were determined comparing gastrotomy closure with LTS and with hand-sewn surgical sutures. Comparison of LTS and hand-sewn surgical gastrotomy closure. The primary outcome parameter was the internal leak pressure. Secondary parameters were the difference between internal and external leak pressures, the impact of an acid environment on the device, histological changes, and feasibility of endoscopic placement. The internal liquid leak pressure after LTS was almost twice as high as after hand-sewn surgical closure (416 ± 53 mm Hg vs 229 ± 99 mm Hg; P = .01). The internal leak pressure (416 ± 53 mm Hg) after LTS was higher than the external leak pressure (154 ± 46 mm Hg; P < .0001). An acidic environment did not affect leak pressure after LTS. Endoscopic LTS closure was feasible in all experiments. Histopathology revealed only slight alterations beneath the soldering plug. In vitro experiments. Leak pressure after LTS closure of gastrotomy is higher than after hand-sewn surgical closure. LTS is a promising technique for closure of gastrotomies and iatrogenic perforations. Further experiments, in particular survival studies, are mandatory. Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Impact of Different Standard Type A7A Drum Closure-Ring Practices on Gasket Contraction and Bolt Closure Distance– 15621

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

Ketusky, Edward; Blanton, Paul; Bobbitt, John H.

The Department of Energy, the Savannah River National Laboratory, several manufacturers of specification drums, and the United States Department of Transportation (DOT) are collaborating in the development of a guidance document for DOE contractors and vendors who wish to qualify containers to DOT 7A Type A requirements. Currently, the effort is focused on DOT 7A Type A 208-liter (55-gallons) drums with a standard 12-gauge bolted closure ring. The U.S. requirements, contained in Title 49, Part 178.350 “Specification 7A; general packaging, Type A specifies a competent authority review of the packaging is not required for the transport of (Class 7) radioactivemore » material containing less than Type A quantities of radioactive material. For Type AF drums, a 4 ft. regulatory free drop must be performed, such that the drum “suffers maximum damage.” Although the actual orientation is not defined by the specification, recent studies suggest that maximum damage would result from a shallow angle top impact, where kinetic energy is transferred to the lid, ultimately causing heavy damage to the lid, or even worse, causing the lid to come off. Since each vendor develops closure recommendations/procedures for the drums they manufacture, key parameters applied to drums during closing vary based on vendor. As part of the initial phase of the collaboration, the impact of the closure variants on the ability of the drum to suffer maximum damage is investigated. Specifically, closure testing is performed varying: 1) the amount of torque applied to the closure ring bolt; and, 2) stress relief protocol, including: a) weight of hammer; and, b) orientation that the hammer hits the closure ring. After closure, the amount of drum lid gasket contraction and the distance that the closure bolt moves through the closure ring is measured.« less

40 CFR 264.280 - Closure and post-closure care.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 25 2010-07-01 2010-07-01 false Closure and post-closure care. 264.280 Section 264.280 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES... § 264.278, except that soil-pore liquid monitoring may be terminated 90 days after the last application...

Transcatheter closure of a large patent ductus arteriosus using jugular access in an infant.

PubMed

Fernandes, Precylia; Assaidi, Anass; Baruteau, Alban-Elouen; Fraisse, Alain

2018-03-01

Trans-catheter device closure of patent ductus arteriosus (PDA) via femoral route is the commonly used, safe and effective procedure. Trans-jugular approach has been successfully used in older children with interrupted inferior vena cava. We report a case of successful occlusion of PDA using Amplatzer duct occluder (ADO) via trans-jugular approach following difficulties encountered in gaining femoral venous access. A 6-month-old male infant, weighing 8 kg was admitted for percutaneous catheter closure of PDA. Echocardiogram showed a 4.5 mm duct and left heart dilatation. Femoral venous access was not possible; therefore, we decided to use a trans-jugular approach. The duct was occluded using 8/6 mm ADO. Successful closure of the duct was confirmed with an aortogram. Post procedure echocardiogram showed no residual shunt across the duct. We highlight that trans-catheter closure of PDA using jugular venous access is safe and effective even in infants.

Device Interventions for Stroke Prevention in Atrial Fibrillation

MedlinePlus

... complex LAA are not suitable because of the design of the LARIAT. The above information is correct ... days before the procedure and replaced with enoxaparin shots (injections). What to Expect the Day of the ...

Transcatheter closure of patent ductus arteriosus using the AMPLATZER™ duct occluder II (ADO II).

PubMed

Gruenstein, Daniel H; Ebeid, Makram; Radtke, Wolfgang; Moore, Phillip; Holzer, Ralf; Justino, Henri

2017-05-01

The study purpose is to evaluate the safety and efficacy of the ADO II device for closure of patent ductus arteriosus (PDA) in children. Transcatheter treatment of PDA has been evolving for 40+ years and is the treatment of choice. The AMPLATZER™ Duct Occluder (ADO) device was developed for larger diameter ducts and is not ideal in all PDAs. ADO II was developed for small to moderate-sized ducts. This is a single-arm, multicenter study evaluating safety and efficacy of the ADO II device. Patients <18 years were screened for a PDA ≤5.5 mm in diameter and 3-12 mm in length. Right and left heart catheterization was performed, and hemodynamic data were obtained at the time of implant. The diameter of the left pulmonary artery (LPA) and descending aorta, and the presence of any pre-existing pressure gradients across the LPA or aortic arch were assessed at baseline and 6 months post-implant. A total of 192 patients were enrolled. The median implant time was 74 min. Median fluoroscopy time was 12 min. A retrograde (aortic) approach was used in 33% of procedures and demonstrated a statistically significant reduction in fluoroscopy time (P value = 0.0018) compared to an antegrade approach. The device was successfully implanted in 93% of patients, with complete closure in 98% of successful implantations. In this prospective study, the ADO II was safe and effective for closure of small to moderate PDAs. Implantation is simple and the ability for retrograde aortic delivery reduces procedure-related radiation exposure. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Transcatheter Closure of Patent Foramen Ovale in Patients with Platypnea-Orthodeoxia: Results of a Multicentric French Registry

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

Guerin, P.; Lambert, V.; Godart, F.

Background. Dyspnea and the decrease in arterial saturation in the upright position in elderly subjects is described as platypnea-orthodeoxia syndrome (POS). POS is secondary to the occurrence of an atrial right-to-left shunt through a patent foramen ovale (PFO). Methods. This French multicentric study reports on 78 patients (mean age 67 {+-} 11.3 years) with POS who had transcatheter closure of the PFO; frequently associated diseases were pneumonectomy (n = 36) and an ascending aortic aneurysm (n = 11). In all patients, the diagnosis was confirmed by transthoracic or/and transesophageal echocardiography. Five different closure devices were used: Amplatz (n = 45),more » Cardioseal (n = 13), Sideris (n = 11), Das Angel Wings (n = 8) and Starflex (n = 1). Closure was successful in 76 patients (97%). Results. Oxygen saturation increased immediately after occlusion from 84.6 {+-} 10.7% to 95.1 {+-} 6.4% (p < 0.001) and dyspnea improved from grade 2.7 {+-} 0.7 to grade 1 {+-} 1 (p < 0.001). A small residual shunt was immediately observed in 5 patients (3 with the Cardioseal device, 1 with the Sideris and 1 with the Amplatz) leading to the implantation of a second device in one case (Cardioseal). Two early deaths occurred unrelated to the procedure (one due to sepsis probably related to pneumonectomy, another due to respiratory insufficiency). Other complications were: a small shunt between the aorta and the left atrium, two atrial fibrillations and a left-sided thrombus which disappeared with anticoagulant therapy. At a mean follow-up of 15 {+-} 12 months, there were 7 late deaths related to the underlying disease. Conclusion. Percutaneous occlusion of the foramen ovale is safe and gives excellent results thanks to continuing improvement in available devices. This technique enables some patients in an unstable condition to avoid a surgical closure.« less

Hybrid approach for closure of muscular ventricular septal defects

PubMed Central

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

2013-01-01

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

Stump closure of a thick pancreas using stapler closure increases pancreatic fistula after distal pancreatectomy.

PubMed

Kawai, Manabu; Tani, Masaji; Okada, Ken-ichi; Hirono, Seiko; Miyazawa, Motoki; Shimizu, Astusi; Kitahata, Yuji; Yamaue, Hiroki

2013-09-01

The appropriate surgical stump closure after distal pancreatectomy (DP) is still controversial. This study investigated the benefits and risks of stapler closure during DP. The risk factors of pancreatic fistulas were investigated in 122 DPs among 3 types of stump closure: hand-sewn suture (n = 32), bipolar scissors (n = 45), and stapler closure (n = 45). There was no significant difference in the incidence of pancreatic fistula between the 3 types of stump closure (hand-sewn suture [44%] vs bipolar scissors [37.7%] vs stapler closure [35.5%]). By using receiver operating characteristics curves, 12 mm was the best cutoff value of the thickness of the pancreas for pancreatic fistulas after DP using stapler closure. Three factors (ie, male sex, body mass index >25 kg/m(2), and stapler closure) were independent risk factors of pancreatic fistulas after DP with a pancreas thicker than 12 mm. A pancreas thicker than 12 mm significantly increased the incidence of pancreatic fistulas after DP using stapler closure. Copyright © 2013 Elsevier Inc. All rights reserved.

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.

Primary closure after carotid endarterectomy is not inferior to other closure techniques.

PubMed

Avgerinos, Efthymios D; Chaer, Rabih A; Naddaf, Abdallah; El-Shazly, Omar M; Marone, Luke; Makaroun, Michel S

2016-09-01

Primary closure after carotid endarterectomy (CEA) has been much maligned as an inferior technique with worse outcomes than in patch closure. Our purpose was to compare perioperative and long-term results of different CEA closure techniques in a large institutional experience. A consecutive cohort of CEAs between January 1, 2000, and December 31, 2010, was retrospectively analyzed. Closure technique was used to divide patients into three groups: primary longitudinal arteriotomy closure (PRC), patch closure (PAC), and eversion closure (EVC). End points were perioperative events, long-term strokes, and restenosis ≥70%. Multivariate regression models were used to assess the effect of baseline predictors. There were 1737 CEA cases (bilateral, 143; mean age, 71.4 ± 9.3 years; 56.2% men; 35.3% symptomatic) performed during the study period with a mean clinical follow-up of 49.8 ± 36.4 months (range, 0-155 months). More men had primary closure, but other demographic and baseline symptoms were similar between groups. Half the patients had PAC, with the rest evenly distributed between PRC and EVC. The rate of nerve injury was 2.7%, the rate of reintervention for hematoma was 1.5%, and the length of hospital stay was 2.4 ± 3.0 days, with no significant differences among groups. The combined stroke and death rate was 2.5% overall and 3.9% and 1.7% in the symptomatic and asymptomatic cohort, respectively. Stroke and death rates were similar between groups: PRC, 11 (2.7%); PAC, 19 (2.2%); EVC, 13 (2.9%). Multivariate analysis showed baseline symptomatic disease (odds ratio, 2.4; P = .007) and heart failure (odds ratio, 3.1; P = .003) as predictors of perioperative stroke and death, but not the type of closure. Cox regression analysis demonstrated, among other risk factors, no statin use (hazard ratio, 2.1; P = .008) as a predictor of ipsilateral stroke and severe (glomerular filtration rate <30 mL/min/1.73 m(2)) renal insufficiency (hazard ratio, 2.6; P�

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

PubMed

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

2016-12-01

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

Effect of transcatheter closure of baffle leaks following senning or mustard atrial redirection surgery on oxygen saturations and polycythaemia.

PubMed

Bentham, James; English, Kate; Hares, Dominic; Gibbs, John; Thomson, John

2012-10-01

The aim of this study was to describe the clinical importance and methods of transcatheter closure of systemic venous baffle leaks after atrial redirection procedures for transposed great vessels. Until the late 1970s, atrial redirection surgery was the principal surgical palliative approach to manage transposed great vessels. Baffle leaks are among the many long-term complications of this type of surgery, and their prevalence increases over time. The clinical consequences of baffle leaks in this population are poorly understood, and the indications for closure are incompletely defined. During outpatient follow-up of 126 patients after atrial redirection surgery, 15 baffle leaks were detected in 11 patients. All underwent transcatheter closure using either an occluding device or a covered stent if there was concomitant baffle obstruction. The average age at the time of the procedure was 26 years (range 6 to 42). Ten of 11 patients were cyanosed at rest or on a simple walk test (median oxygen saturation level 80%, range 65% to 96%). Six of 11 patients were polycythemic before leak closure (median hemoglobin concentration 19 g/dl, range 13.8 to 23). After closure, there was a significant improvement in saturation (median 97%, p <0.0001) and a significant reduction in hemoglobin concentration at 6 months after the procedure (median 14.8 g/dl, p <0.05). There were no procedural adverse events. One patient experienced late device embolization necessitating surgical removal. In conclusion, transcatheter closure of baffle leaks is a technically feasible although frequently complex and lengthy procedure. Closure is associated with an improvement in oxygen saturations and a reduction in polycythaemia. Copyright © 2012 Elsevier Inc. All rights reserved.

Transcatheter closure of moderate-to-large patent ductus arteriosus in infants using Amplatzer duct occluder.

PubMed

Wang, Jou-Kou; Wu, Mei-Hwan; Lin, Ming-Tai; Chiu, Shuenn-Nan; Chen, Chun-An; Chiu, Hsin-Hui

2010-02-01

There are difficulties in transcatheter closure of patent ductus arteriosus (PDA) in infants. The 46 infants (mean age 6.2+/-2.7 months; mean body weight 6.3+/-1.6 kg) who underwent PDA closure using the Amplatzer duct occluder (ADO). The indication for using an ADO was a ductus diameter > or =2.5 or 3 mm. Device diameter selected was 1-3 mm larger than ductal diameter. The mean systolic pulmonary artery pressure was 40.9+/-18.2 mmHg. The mean Qp/Qs ratio was 3.1+/-1.2. The mean ductus diameter was 3.3+/-0.8 mm. ADO was successfully deployed in 45 patients. Failure occurred in 1 case. The mean diameter of device used was 5.4+/-1.1 mm. No severe complications occurred. At the 1-month echocardiographic follow-up, a small residual shunt was present in 4 of 45 patients and had disappeared in all 4 patients at the 3-month follow-up. One patient developed a moderate degree of left ventricular outflow tract obstruction 2.3 years after the procedure. Transcatheter closure of PDA in infants using the ADO is a safe and effective method.

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

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

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 suturesmore » with a 2×2×2×2 knot) used in monitoring and research programs with a novel antiseptic barrier on the wound (“Second Skin”).« less

Transcatheter closure of patent foramen ovale for secondary prevention of ischemic stroke: Quantitative synthesis of pooled randomized trial data.

PubMed

Hakeem, Abdul; Cilingiroglu, Mehmet; Katramados, Angelos; Boudoulas, Konstantinos Dean; Iliescu, Cezar; Gundogdu, Betul; Marmagkiolis, Konstantinos

2018-01-14

To evaluate the safety and efficacy of percutaneous device closure of patent foramen ovale (PFO) for secondary prevention of ischemic stroke BACKGROUND: Stroke remains the leading cause of serious long-term disability in the United States. The effectiveness of a percutaneous PFO closure in the prevention of recurrent cryptogenic strokes has not been established. We performed a literature search using PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Google Scholar, and Internet-based sources from January 2003 to September 2017. Randomized controlled trails (RCTs) comparing percutaneous PFO closure to medical therapy alone. Five RCTs (CLOSURE I, PC Trial, REDUCE, RESPECT, and CLOSE) with 1,829 patients in the device group and 1,611 patients in the medical group met inclusion criteria. The cumulative incidence of recurrent stroke was 2.02% in the PFO closure arm and 4.4% in the medical therapy group (RR 0.42, 95%CI 0.20, 0.91; P = 0.03). There was no difference in the incidence of death [0.7% vs. 0.9%; RR 0.76 (95% CI 0.35, 1.64), P = 0.49] or adverse events during the follow-up period [24.6% vs. 23.7% (RR 1.03; 95% CI 0.91, 1.16), P = 0.65] between the closure and medical therapy groups. Incidence of atrial fibrillation was significantly higher in closure group compared to medical therapy [4% vs. 0.6% (RR 4.73; 95% CI 2.09, 10.70), P = 0.0002]. The comparative effectiveness of PFO closure (compared to medical therapy) was significantly more pronounced in those younger than 45 years, males, larger shunts and disc design platforms (P < 0.05). Based on the results of this analysis of randomized trial data, percutaneous PFO closure appears to be a safe and effective therapeutic option for the secondary prevention of ischemic stroke in patients with PFO and cryptogenic stroke. © 2018 Wiley Periodicals, Inc.

40 CFR 264.146 - Use of a mechanism for financial assurance of both closure and post-closure care.

Code of Federal Regulations, 2013 CFR

2013-07-01

... assurance of both closure and post-closure care. 264.146 Section 264.146 Protection of Environment... mechanism for financial assurance of both closure and post-closure care. An owner or operator may satisfy the requirements for financial assurance for both closure and post-closure care for one or more...

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…

40 CFR 265.146 - Use of a mechanism for financial assurance of both closure and post-closure care.

Code of Federal Regulations, 2013 CFR

2013-07-01

... assurance of both closure and post-closure care. 265.146 Section 265.146 Protection of Environment... Use of a mechanism for financial assurance of both closure and post-closure care. An owner or operator may satisfy the requirements for financial assurance for both closure and post-closure care for one or...

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

PubMed

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

2018-06-04

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

Pelvic flexure enterotomy closure in the horse with a TA-90 stapling device: A retrospective clinical study of 84 cases (2001–2008)

PubMed Central

Rosser, Julie; Brounts, Sabrina; Slone, Don; Lynch, Tim; Livesey, Michael; Hughes, Faith; Clark, Carol

2012-01-01

Our objective was to compare survival and complication rates of horses undergoing pelvic flexure enterotomy closure with a TA-90 stapler to those with hand-sewn closure. Medical records of horses undergoing pelvic flexure enterotomy between 2001 and 2008 were reviewed. History, clinical signs, surgical findings, surgical techniques, and post-operative complications were recorded. Long-term outcome was established by telephone questionnaire. Of 84 pelvic flexure enterotomies performed, 70 were stapled and 14 were hand-sewn. Seventy-seven horses survived to discharge (91.7%). There were no significant associations between survival and closure technique (P = 0.69). Follow-up was available for 54 horses; 50 survived long-term (93.0%). No statistical significance was identified between long-term survival and closure method (P = 0.39). Forty horses went on to athletic performance (80.0%). TA-90 stapled closure of pelvic flexure enterotomies is a safe technique resulting in survival and complication rates equivalent to those of hand-sewn closure. PMID:23204584

Amplatzer angled duct occluder for closure of patent ductus arteriosus larger than the aorta in an infant.

PubMed

Vijayalakshmi, I B; Chitra, N; Rajasri, R; Prabhudeva, A N

2005-01-01

Transcatheter closure of patent ductus arteriosus (PDA) by Amplatzer duct occluder is the treatment of choice. However, closure of very large ducts in infants with low weight is a challenge for the interventionalist because a large device may obstruct the aorta or left pulmonary artery. Difficulty is also encountered in advancing the device around the curve of the right ventricular outflow tract toward the pulmonary artery; this curve is tight, more or less at a right angle in infants, leading to kinking of the sheath, which increases fluoroscopic time. This is the first reported case of a very large PDA (8.7 mm), larger than the aorta (8.2 mm), successfully closed by an Amplatzer angled duct occluder in an infant weighing 5 kg.

Observation of a periodic array of flux-closure quadrants in strained ferroelectric PbTiO 3 films

DOE PAGES

Tang, Y. L.; Zhu, Y. L; Ma, Xiuliang; ...

2015-05-01

Nanoscale ferroelectrics are expected to exhibit various exotic domain configurations, such as the full flux-closure pattern that is well known in ferromagnetic materials. Here we observe not only the atomic morphology of the flux-closure quadrant but also a periodic array of flux closures in ferroelectric PbTiO 3 films, mediated by tensile strain on a GdScO 3 substrate. Using aberration-corrected scanning transmission electron microscopy, we directly visualize an alternating array of clockwise and counterclockwise flux closures, whose periodicity depends on the PbTiO 3 film thickness. In the vicinity of the core, the strain is sufficient to rupture the lattice, with strainmore » gradients up to 10 9 per meter. We found engineering strain at the nanoscale may facilitate the development of nanoscale ferroelectric devices.« less

Laceration of the Common Femoral Artery Following Deployment of the StarClose{sup TM} Vascular Closure System

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

Gonsalves, Michael, E-mail: drmag1975@gmail.com; Walkden, Miles, E-mail: rwalkden@nhs.net; Belli, Anna Maria, E-mail: Anna.Belli@stgeorges.nhs.u

2008-07-15

StarClose is a novel arterial closure device which achieves hemostasis, following arteriotomy, via a nitinol clip deployed on the outer arterial wall. Since its introduction to the market, several studies have shown StarClose to be both safe and effective, with few major complications encountered. We report a case of common femoral artery laceration following deployment of the StarClose vascular closure system. We conclude that the injury occurred secondary to intravascular misplacement of the nitinol clip.

77 FR 55496 - Notice of Temporary Closure of Public Lands in Eastern Lassen County, California, and Western...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-10

... protection and State, local and Federal officials involved with enforcement. This closure is necessary to.... Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay...

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.

A blinded, prospective, randomized controlled trial of topical negative pressure wound closure in India.

PubMed

Mody, Gita N; Nirmal, Ida Anita; Duraisamy, Sulochana; Perakath, Benjamin

2008-12-01

Wound closure using topical negative pressure (TNP) has been reported to be effective, but equipment costs can be prohibitive in resource-challenged countries. Because nonhealing wounds are exceedingly common in developing countries such as India, the ability to optimize wound care with limited resources is very important. To investigate the feasibility and efficacy of providing TNP in an Indian medical referral center, a randomized controlled trial comparing a locally constructed TNP device (treatment) to wet-to-dry gauze dressings (control) was conducted. Eligible study participants (N = 48) were recruited from the inpatient wards. Wound etiologies included diabetic foot ulcers (15), pressure ulcers (11), cellulitis/fasciitis (11), and "other" (11). Following enrollment, wound size was assessed using computer-aided measurements of digital photographs and block-randomized to the study arms using a concealed allocation table. Wounds in both treatment groups were débrided before dressing application and patients were followed until wound closure or being lost to follow-up for an average of 26.3 days (+/- 18.5) in the control and 33.1 days (+/- 37.3) in the treatment group. No statistically significant differences in time to closure between the two treatment groups were observed except in a subset analysis of pressure ulcers (mean 10 +/- 7.11 days for treatment and 27 +/- 10.6 days in control group, P = 0.05). Direct costs to close a pressure ulcer also were lower in the TNP than in the control group. A review of the literature suggests the outcomes obtained using a locally constructed TNP device are similar to those obtained using commercially available devices. As a result of this study, a dedicated tissue viability team has been established to identify wounds suitable for TNP, oversee treatment, monitor the need for surgical débridement, and employ wound healing principles and technology appropriately. These results suggest that inexpensive materials can be

Patent ductus arteriosus closure using Occlutech® Duct Occluder, experience in Port Elizabeth, South Africa

PubMed Central

Pepeta, Lungile; Greyling, Adele; Nxele, Mahlubandile Fintan; Makrexeni, Zongezile Masonwabe

2017-01-01

Background: Percutaneous closure of patent ductus arteriosus (PDA) has become standard therapy. Experience with the Occlutech® Duct Occluder is limited. Methods: Data regarding ductal closure using Occlutech® Duct Occluder were reviewed and prospectively collected. Demographics, hemodynamic and angiographic characteristics, complications, and outcomes were documented. Results: From March 2013 to June 2016, 65 patients (43 females and 22 males) underwent percutaneous closure of the PDA using Occlutech® Duct Occluder. The median age of the patients was 11 months (range, 1–454 months) and the median weight was 8.5 kg (range 2.5–78 kg). The mean pulmonary artery median pressure was 27 mmHg (range, 12–100 mmHg) and the QP: Qs ratio median was 1.8 (range, 1–7.5), with a pulmonary vascular resistance mean of 2.7 WU (standard deviation [SD] ±2.1). Thirty-two patients had Krichenko Type A duct (49%); 7, Type C (11%); 4, Type D (6%); and 22, Type E (34%). The ductal size (narrowest diameter at the pulmonic end) mean was 3.5 mm (SD ± 1.9 mm). The screening time mean was 17.3 min (SD ± 11.6). Out of 63 patients with successful closure of the PDA using Occlutech® Duct Occluder, there were 15 patients with small PDAs; 25 with moderate PDAs, and 23 with large PDAs. In one patient, the device dislodged to the descending aorta, and in two patients, to the right pulmonary artery immediately following deployment, with successful percutaneous (two) and surgical (one) retrieval. Complete ductal occlusion was achieved in all 63 patients on day one. Conclusion: The Occlutech® Duct Occluder is a safe and effective device for closure of ducts in appropriately selected patients. PMID:28566820

Patent ductus arteriosus closure using Occlutech® Duct Occluder, experience in Port Elizabeth, South Africa.

PubMed

Pepeta, Lungile; Greyling, Adele; Nxele, Mahlubandile Fintan; Makrexeni, Zongezile Masonwabe

2017-01-01

Percutaneous closure of patent ductus arteriosus (PDA) has become standard therapy. Experience with the Occlutech® Duct Occluder is limited. Data regarding ductal closure using Occlutech® Duct Occluder were reviewed and prospectively collected. Demographics, hemodynamic and angiographic characteristics, complications, and outcomes were documented. From March 2013 to June 2016, 65 patients (43 females and 22 males) underwent percutaneous closure of the PDA using Occlutech® Duct Occluder. The median age of the patients was 11 months (range, 1-454 months) and the median weight was 8.5 kg (range 2.5-78 kg). The mean pulmonary artery median pressure was 27 mmHg (range, 12-100 mmHg) and the QP: Qs ratio median was 1.8 (range, 1-7.5), with a pulmonary vascular resistance mean of 2.7 WU (standard deviation [SD] ±2.1). Thirty-two patients had Krichenko Type A duct (49%); 7, Type C (11%); 4, Type D (6%); and 22, Type E (34%). The ductal size (narrowest diameter at the pulmonic end) mean was 3.5 mm (SD ± 1.9 mm). The screening time mean was 17.3 min (SD ± 11.6). Out of 63 patients with successful closure of the PDA using Occlutech® Duct Occluder, there were 15 patients with small PDAs; 25 with moderate PDAs, and 23 with large PDAs. In one patient, the device dislodged to the descending aorta, and in two patients, to the right pulmonary artery immediately following deployment, with successful percutaneous (two) and surgical (one) retrieval. Complete ductal occlusion was achieved in all 63 patients on day one. The Occlutech® Duct Occluder is a safe and effective device for closure of ducts in appropriately selected patients.

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

PubMed

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

2011-01-01

The transcatheter closure of the atrial septal defect (ASD) has become an alternative technique to surgical procedures. The aim of this study was to assess the immediate, short, and intermediate-term results of the transcatheter closure of the secundum ASD with the Amplatzer Septal Occluder (ASO) in adult Iranian patients. Between December 2004 and July 2008, the transcatheter closure of the ASD using the ASO was attempted in 58 consecutive, adult patients. The mean age of the patients was 37.1 ± 12.7 years (range = 19 - 75 years). All the procedures were performed under local anesthesia with transthoracic or transesophageal echocardiography and fluoroscopic guidance. The stretched diameter of the ASD was determined with a balloon sizing catheter, and device selection was based on and matched to the stretched diameter of the septal defect. Transthoracic echocardiography was performed immediately after the release of the device and before discharge. Further follow-up at one month, six months, and yearly thereafter included physical examination, electrocardiography, and transthoracic echocardiography. The mean ASD diameter, as measured by esophageal echocardiography, was 24.8 ± 5.4 mm (range = 13 - 34 mm). The mean stretched diameter, as measured by the balloon catheter, was 27.1 ± 6.4 mm (range = 12.5 - 39 mm). Deployment of the ASO was successful in 52 (89.6%) patients and failed in 6 (10.4%). Four patients experienced severe complications, 1 had tamponade requiring drainage, 2 had device embolization to the left atrium and right ventricular outflow tract, and 1 had late wire fracture (surgical removal and repair of the ASD). The position of two large devices (34 mm and 36 mm) was considered unsuitable and unstable after implantation and resulted in the removal of these devices. Minor complications included transient complete atrioventricular block in 1 patient, paroxysmal supra tachycardia in 3 patients, atrial flutter in 1 patient, and angina pectoris with

[Resistance to pressure of bronchial closures. Comparison of pressure resistance of manual and stapler bronchial closures depending on the angle to the cartilaginous rings].

PubMed

Ludwig, C; Behrend, M; Hoffarth, U; Schüttler, W; Stoelben, E

2004-09-01

This study was aimed to determine the resistance to pressure of manual and stapled bronchial closures under ideal conditions (90 degrees to the bronchial tree) and parallel to the trachea (45 degrees). An experimental study was done on 60 explanted pig tracheae which were alternatively closed with either double-layer, running sutures angled 90 degrees to the cartilaginous rings or an automatic stapling device. The closure line was placed exactly 90 degrees to the bronchial tree in 30 cases and parallel to the trachea (45 degrees) in 30. The sutures were placed under pressure until air leakage was observed. The leakage pressure was digitally recorded. A statistically significant difference existed between the two groups. Mechanical sutures proved more resistant to pressure (P=0.011). Under ideal conditions, the resistance to pressure of mechanical sutures is equal to if not better than that of manual sutures.

Closure Report for Corrective Action Unit 426: Cactus Spring Waste Trenches, Tonopah Test Range, Nevada

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

Dave Madsen

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 northwest of Las Vegas, NV. CAU 426 consists of one corrective action site (CAS) which is comprised of four waste trenches. The trenches were excavated to receive solid waste generated in support of Operation Roller Coaster, primary the Double Tracks Test in 1963, and were subsequently backfilled. The Double Tracks Test involved use of live animals to assess the biological hazards associated with the nonnuclear detonation of plutonium-bearing devices.more » The Nevada Division of Environmental Protection approved Corrective Action Plan (CAP)which proposed ''capping'' methodology. The closure activities were completed in accordance with the approved CAP and consisted of constructing an engineered cover in the area of the trenches, constructing/planting a vegetative cover, installing a perimeter fence and signs, implementing restrictions on future use, and preparing a Post-Closure Monitoring Plan.« less

A novel technique for transcatheter patent ductus arteriosus closure in extremely preterm infants using commercially available technology.

PubMed

Zahn, Evan M; Nevin, Phillip; Simmons, Charles; Garg, Ruchira

2015-02-01

To describe a new technique for transcatheter patent ductus arteriosus (PDA) closure in extremely preterm infants using commercially available technology. PDA in premature neonates continues to be a significant clinical problem contributing importantly to both morbidity and mortality. Surgical ligation and medical therapy both have their drawbacks. Hospital records and catheterization reports of all premature neonates (< 32 weeks gestation) who underwent transcatheter PDA closure between March 2013 and February 2014 were reviewed. Particular attention was paid to procedural details, complications, and short and mid-term outcomes. Six premature infants born at gestational ages ranging between 26 and 31 weeks (median, 26 weeks) underwent attempted transcatheter PDA closure using the Amplatzer Vascular Plug II (AVP II). Median age and weight was 21.5 days (16-80 days) and 1,180 g (870-2,240 g), respectively. Fluoroscopy and echocardiography were used to guide device. Contrast angiography was not used in any patient. Complete closure was achieved in all patients with no major procedural complications. Median fluoroscopy and procedural times were 9.4 (0-19.5) and 51.5 (33-87) min, respectively. All patients were alive at the time of this report. There were no instances of device migration, left pulmonary artery (LPA), or aortic coarctation. This preliminary study demonstrates that transcatheter PDA closure can be successfully performed in extremely preterm neonates using currently available technology with a high success rate and a low incidence of complications. This report also describes a novel transvenous approach using a combination of echocardiography and judicious use of fluoroscopy to avoid arterial access in this fragile patient population. © 2014 Wiley Periodicals, Inc. © 2014 Wiley Periodicals, Inc.

Percutaneous Patent Ductus Arteriosus (PDA) Closure in Very Preterm Infants: Feasibility and Complications.

PubMed

Backes, Carl H; Cheatham, Sharon L; Deyo, Grace M; Leopold, Scott; Ball, Molly K; Smith, Charles V; Garg, Vidu; Holzer, Ralf J; Cheatham, John P; Berman, Darren P

2016-02-12

Percutaneous closure of patent ductus arteriosus (PDA) in term neonates is established, but data regarding outcomes in infants born very preterm (<32 weeks of gestation) are minimal, and no published criteria exist establishing a minimal weight of 4 kg as a suitable cutoff. We sought to analyze outcomes of percutaneous PDA occlusion in infants born very preterm and referred for PDA closure at weights <4 kg. Retrospective analysis (January 2005-January 2014) was done at a single pediatric center. Procedural successes and adverse events were recorded. Markers of respiratory status (need for mechanical ventilation) were determined, with comparisons made before and after catheterization. A total of 52 very preterm infants with a median procedural weight of 2.9 kg (range 1.2-3.9 kg) underwent attempted PDA closure. Twenty-five percent (13/52) of infants were <2.5 kg. Successful device placement was achieved in 46/52 (88%) of infants. An adverse event occurred in 33% of cases, with an acute arterial injury the most common complication. We observed no association between weight at time of procedure and the risk of an adverse event. No deaths were attributable to the PDA closure. Compared to precatheterization trends, percutaneous PDA closure resulted in improved respiratory status, including less exposure to mechanical ventilation (mixed effects logistic model, P<0.01). Among infants born very preterm, percutaneous PDA closure at weights <4 kg is generally safe and may improve respiratory health, but risk of arterial injury is noteworthy. Randomized clinical trials are needed to assess clinically relevant differences in outcomes following percutaneous PDA closure versus alternative (surgical ligation) management strategies. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Observations on early and delayed colostomy closure.

PubMed

Tade, A O; Salami, B A; Ayoade, B A

2011-06-01

Traditional treatment of a variety of colorectal pathologies had included a diverting colostomy that was closed eight or more weeks later during a readmission. The aim of this retrospective study was to determine the outcomes of early colostomy closure and delayed colostomy closure in patients with temporary colostomies following traumatic and non-traumatic colorectal pathologies. In this study early colostomy closure was the closure of a colostomy within three weeks of its construction, while delayed colostomy closure referred to closure after 3 weeks. Complete records of the 37 adult patients who had temporary colostomy constructed and closed between Jan. 1997 December 2003 for various colorectal pathologies were studied. Fourteen patients had early colostomy closure while 23 had delayed closure. In the early colostomy closure group there were 10 men and 4 women. The mean age of the patients was 28yr with a range of 18-65yr. Colostomies were closed 9-18 days after initial colostomy construction. There was no mortality. Morbidity rate 28.6% (4 out of 14). There were two faecal fistulas (14.3%). Twenty-three patients had delayed colostomy closure 8 weeks to 18 months after initial colostomy construction. These were patients unfit for early surgery after initial colostomy construction because of carcinoma, significant weight loss, or sepsis. There was no mortality. Morbidity rate was 26.1%. There were 3 faecal fistulas (13.2%). Outcomes following early colostomy closure and delayed closure were comparable. Patients fit for surgery should have early closure whilst patients who may have compromised health should have delayed closure.

RCRA, superfund and EPCRA hotline training module. Introduction to: Closure/post-closure (40 cfr parts 264/265, subpart g) updated July 1996

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

NONE

1996-07-01

The module explains the difference between closure and post-closure. It lists the types of facilities that are subject to closure/post-closures and defines the difference between partial and final closure. It specifies who submits a closure plan and when a closure plan must be submitted, lists the steps in the process, and states the time frame for submittal. It identifies when and how a closure must be amended. It explains the time frame for notification of closure and the deadlines for beginning and completing closure. It specifies which facilities need contingent post-closure plans and lists and the elements of post-closure andmore » cites the requirements. It specifies the conditions and timing for amending a post-closure plan and states who must certify closure/post-closure.« less

Effects of ventricular rate and regularity on the velocity and magnitude of left atrial appendage flow in atrial fibrillation

PubMed Central

Obel, O A; Luddington, L; Maarouf, N; Aytemir, K; Ekwall, C; Malik, M; Camm, A J

2005-01-01

Objective: To prospectively determine whether ventricular rate and regularity are significant determinants of the velocity and magnitude of left atrial appendage (LAA) flow. Design and patients: 12 patients with atrial fibrillation (AF), high degree atrioventricular block, and indwelling permanent pacemakers were studied. Setting: Cardiology department of a tertiary referral centre. Interventions: Pacing was triggered by an external programmable transcutaneous device. Patients were paced at 60, 120, and 150 beats/min in both regular and irregular rhythm. LAA flow velocity and magnitude were assessed with transoesophageal Doppler echocardiography. Main outcome measures: Peak and mean LAA inflow and outflow velocity, and time-velocity interval (TVI) of LAA flow. Results: Increasing ventricular rate was associated with significantly lower peak inflow (p < 0.01), peak outflow (p < 0.05), mean inflow (p < 0.01), and mean outflow (p < 0.05) velocities and with a lower TVI of LAA filling and emptying velocities (p < 0.01). This effect was noted at rates of 60 beats/min compared with both 120 and 150 beats/min. At a pacing rate of 120 beats/min there was a significantly higher total TVI when pacing at a regular than at an irregular rhythm (40.16 (14.6) cm v 30.74 (10.9) cm, p < 0.05). Conclusions: In this study, LAA filling velocities in patients in AF were significantly influenced by paced ventricular rate and to a much lesser extent ventricular rhythm. These results suggest that rapid ventricular rates may predispose to stasis in the LAA in AF. PMID:15894771

Designing Comparative Effectiveness Trials of Surgical Ablation for Atrial Fibrillation: Experience of the Cardiothoracic Surgical Trials Network

PubMed Central

Gillinov, A. Marc; Argenziano, Michael; Blackstone, Eugene H.; Iribarne, Alexander; DeRose, Joseph J.; Ailawadi, Gorav; Russo, Mark J.; Ascheim, Deborah D.; Parides, Michael K.; Rodriguez, Evelio; Bouchard, Denis; Taddei-Peters, Wendy C.; Geller, Nancy L.; Acker, Michael A.; Gelijns, Annetine C.

2013-01-01

Background Since the introduction of the cut-and-sew Cox-Maze procedure for atrial fibrillation (AF) there has been substantial innovation in techniques for ablation. Use of alternate energy sources for ablation simplified the procedure and has resulted in dramatic increase in the number of AF patients treated by surgical ablation. Despite its increasingly widespread adoption, there is lack of rigorous clinical evidence to establish this as an effective clinical therapy. Methods and Results This paper describes a comparative effectiveness randomized trial, supported by the Cardiothoracic Surgical Trials Network, of surgical ablation with left atrial appendage (LAA) closure versus LAA closure alone in patients with persistent and longstanding persistent AF undergoing mitral valve surgery. Nested within this trial, is a further randomized comparison of 2 different lesions sets: pulmonary vein isolation and full Maze lesion set. This paper addresses trial design challenges, including how to best characterize the target population, operationalize freedom from AF as a primary endpoint, account for the impact of anti-arrhythmic drugs, and measure and analyze secondary endpoints, such as post-operative AF load. Conclusions This paper concludes by discussing how insights that emerge from this trial may affect surgical practice and guide future research in this area. PMID:21616507

Full closure strategic analysis.

DOT National Transportation Integrated Search

2014-07-01

The full closure strategic analysis was conducted to create a decision process whereby full roadway : closures for construction and maintenance activities can be evaluated and approved or denied by CDOT : Traffic personnel. The study reviewed current...

Crack closure, a literature study

NASA Astrophysics Data System (ADS)

Holmgren, M.

1993-08-01

In this report crack closure is treated. The state of the art is reviewed. Different empirical formulas for determining the crack closure are compared with each other, and their benefits are discussed. Experimental techniques for determining the crack closure stress are discussed, and some results from fatigue tests are also reported. Experimental data from the literature are reported.

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... of material to be used in plugging; (iv) The method of placement of the plugs; (v) Any proposed test...

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).

System for closure of a physical anomaly

DOEpatents

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.

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

PubMed

Ramesh, S; Ajik, S

2012-12-01

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

Automated Road Closure Gate

DOT National Transportation Integrated Search

2000-05-01

This report presents the procedures involved in the research, design, construction, and testing of an Automated Road Closure Gate. The current road closure gates used in South Dakota are often unsafe and difficult to operate. This report will assist ...

Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial.

PubMed

Diener, Markus K; Seiler, Christoph M; Rossion, Inga; Kleeff, Jörg; Glanemann, Matthias; Butturini, Giovanni; Tomazic, Ales; Bruns, Christiane J; Busch, Olivier R C; Farkas, Stefan; Belyaev, Orlin; Neoptolemos, John P; Halloran, Christopher; Keck, Tobias; Niedergethmann, Marco; Gellert, Klaus; Witzigmann, Helmut; Kollmar, Otto; Langer, Peter; Steger, Ulrich; Neudecker, Jens; Berrevoet, Frederik; Ganzera, Silke; Heiss, Markus M; Luntz, Steffen P; Bruckner, Thomas; Kieser, Meinhard; Büchler, Markus W

2011-04-30

The ideal closure technique of the pancreas after distal pancreatectomy is unknown. We postulated that standardised closure with a stapler device would prevent pancreatic fistula more effectively than would a hand-sewn closure of the remnant. This multicentre, randomised, controlled, parallel group-sequential superiority trial was done in 21 European hospitals. Patients with diseases of the pancreatic body and tail undergoing distal pancreatectomy were eligible and were randomly assigned by central randomisation before operation to either stapler or hand-sewn closure of the pancreatic remnant. Surgical performance was assessed with intraoperative photo documentation. The primary endpoint was the combination of pancreatic fistula and death until postoperative day 7. Patients and outcome assessors were masked to group assignment. Interim and final analysis were by intention to treat in all patients in whom a left resection was done. This trial is registered, ISRCTN18452029. Between Nov 16, 2006, and July 3, 2009, 450 patients were randomly assigned to treatment groups (221 stapler; 229 hand-sewn closure), of whom 352 patients (177 stapler, 175 hand-sewn closure) were analysed. Pancreatic fistula rate or mortality did not differ between stapler (56 [32%] of 177) and hand-sewn closure (49 [28%] of 175; OR 0·84, 95% CI 0·53–1·33; p=0·56). One patient died within the fi rst 7 days after surgery in the hand-sewn group; no deaths occurred in the stapler group. Serious adverse events did not differ between groups. Stapler closure did not reduce the rate of pancreatic fistula compared with hand-sewn closure for distal pancreatectomy. New strategies, including innovative surgical techniques, need to be identified to reduce this adverse outcome. German Federal Ministry of Education and Research.

[Percutaneous closure of the patent ductus arteriosus in children with the Amplatzer Duct Occluder II].

PubMed

Parra-Bravo, José Rafael; Osuna-Izaguirre, Manuel Alfredo; Beirana-Palencia, Luisa; Gálvez-Cancino, Franco; Martínez-Monterrosas, Christian; Lazo-Cárdenas, César; Reyes-Vargas, César

2014-01-01

In the last decades, several devices have been used for the percutaneous closure of patent ductus arteriosus, with its own limitations and risks. The Amplatzer Duct Occluder II has been designed to overcome those limitations and reduce risks. We described our initial series of patients who underwent percutaneous closure of patent ductus arteriosus with the Amplatzer Duct Occluder II, emphasis on the technical aspects of the procedure. We reviewed the clinical records of 9 patients with patent ductus arteriosus who underwent percutaneous closure with the Amplatzer Duct Occluder II. Median age was 24 months (range 8-51 months) and the median weight was 10.7kg (range 6-16.3kg). The minimal ductus arteriosus diameter was 2.7mm (1-5mm). Implantation was successful in all cases. The devices most commonly used (33.3%) were the dimensions 4-4mm (3 patients), in 2 patients were used 3-4mm and in the rest of the patients were employed occluder other sizes. Four cases showed slight residual flow immediately after implantation. Total closure was achieved in 24h in 8 of 9 patients (89%). There was no embolization of the occluder or deaths during the procedure and we only observed one minor complication. The Amplatzer Duct Occluder II in this series was effective in 89% of the patients at 24hs after the procedure and 100% follow-up. The implantation was safe and no major complications were observed. The occlusion rate is comparable to those reported for the Amplatzer Duct Occluder I. Copyright © 2013 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

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)

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

Complications with Angio-Seal™ vascular closure devices compared with manual compression after diagnostic cardiac catheterization and percutaneous coronary intervention.

PubMed

Gregory, Deborah; Midodzi, William; Pearce, Neil

2013-12-01

This study assessed and compared vascular complications in CATHs and PCIs using an Angio-Seal™ vascular closure device (VCD) versus manual compression (MC). Secondary data analysis of a population-based multiyear cohort database was conducted to compare femoral access-related vascular outcomes in cardiac procedures using VCD and MC between May 1, 2006 and December 31, 2010. The primary outcome was any vascular complication. Propensity score adjusted analysis was conducted to reduce bias associated with covariate imbalance between the groups compared. Of the 11,897 procedures, 7,063 (59.4%) used a VCD. Vascular complications occurred in 174/8,796 (2.0%) of CATHs and 82/3,004 (2.7%) of PCIs. In the CATH sample, the odds of vascular complication were 57% lower if a VCD was used (OR = 0.43, 95% CI 0.31-0.60). For the PCI sample, the risk was 49% lower if a VCD was used (OR = 0.51, 95% CI 0.31-0.81). A low incidence of vascular complications was observed with the use of an Angio-Seal VCD relative to MC for both procedures. © 2013, Wiley Periodicals, Inc.

Economic comparison of methods of wound closure: wound closure strips vs. sutures and wound adhesives.

PubMed

Zempsky, William T; Zehrer, Cindy L; Lyle, Christopher T; Hedbloom, Edwin C

2005-09-01

Our objective was to review and assess the treatment of low-tension wounds and evaluate the cost-effectiveness of wound closure methods. We used a health economic model to estimate cost/closure of adhesive wound closure strips, tissue adhesives and sutures. The model incorporated cost-driving variables: application time, costs and the likelihood and costs of dehiscence and infection. The model was populated with variable estimates derived from the literature. Cost estimates and cosmetic results were compared. Parameter values were estimated using national healthcare and labour statistics. Sensitivity analyses were used to verify the results. Our analysis suggests that adhesive wound closure strips had the lowest average cost per laceration ($7.54), the lowest cost per infected laceration ($53.40) and the lowest cost per laceration with dehiscence ($25.40). The costs for sutures were $24.11, $69.91 and $41.91, respectively; the costs for tissue adhesives were $28.77, $74.68 and $46.68, respectively. The cosmetic outcome for all three treatments was equivalent. We conclude adhesive wound closure strips were both a cost-saving and a cost-effective alternative to sutures and tissue adhesives in the closure of low-tension lacerations.

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

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

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.

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

PubMed Central

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

2017-01-01

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

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

PubMed

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

2015-03-01

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

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

DOE PAGES

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

2018-03-25

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

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

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

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

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

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

PubMed

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

2012-07-01

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

Comparison of Outcomes with Hand-sewn Versus Stapler Closure of Pancreatic Stump in Distal Pancreatectomy.

PubMed

Futagawa, Yasuro; Takano, Yuki; Furukawa, Kenei; Kanehira, Masaru; Onda, Shinji; Sakamoto, Taro; Gocho, Takeshi; Shiba, Hiroaki; Yanaga, Katsuhiko

2017-05-01

The optimal method for pancreatic stump closure to prevent postoperative pancreatic fistula (POPF) after distal pancreatectomy (DP), remains controversial though DP is still the only curative treatment for pancreatic cancer and other malignancies located on pancreatic body or tail. A total of 44 patients who consecutively underwent open DP were retrospectively analyzed, dividing them into two groups: group H (hand-sewn; n=24) and group S (stapler closure; n=20). POPFs were encountered in 5 (21%) and 11 (55%) patients in groups H and S, respectively (p=0.02). POPFs of Clavien-Dindo grade IIIa or above were observed in two (8%) and seven (35%) patients in groups H and S, respectively (p=0.03). When indicating stapler closure, caution should be exercised for pancreatic consistency and thickness, device and cartridge type, and pancreatic duct ligation to more effectively control POPF rates. Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Safety and efficacy of Cardi-O-fix occluder for percutaneous closure of a patent foramen ovale

PubMed Central

Zhao, Enfa; Liu, Wenjuan; Zhang, Yushun; Cheng, Gesheng; Du, Yajuan; He, Lu; Wang, Xingye; He, Xumei

2017-01-01

Abstract Background: Amplatzer occluder and Cardio-O-fix occluder are currently used in percutaneous closure of patent foramen ovale. However, there is still a lack of relevant reports comparison the differences between them. The aim of this study was to evaluate the short-term and mid-term safety and efficacy of the Cardi-O-fix occluder in preventing recurrent cerebrovascular events in patients with a patent foramen ovale (PFO). Methods: We enrolled 246 patients (105 men) with a PFO from May 30, 2013 to March 30, 2015 in this single-center prospective study. All patients were treated by PFO interventional closure, with the Cardi-O-fix PFO occluder being used in 180 patients and the Amplatzer PFO occluder being utilized in the remaining 66 patients. After the procedure, we verified the safety and efficacy of different devices using contrast transthoracic echocardiography. Results: Neither recurrent stroke nor death was encountered during the follow-up of 12 months. Transient ischemic attack (TIA) was noted in 2 patients (1.1%) in the Cardi-O-fix PFO occluder group, and 1 patient suffered from TIA (1.5%) in the Amplatzer PFO occluder group. Among them, only 1 patient exhibited a small right to left shunt (RLS). There was no statistical difference in recurrent cerebral ischemic events. Three cases of paroxysmal atrial fibrillation were observed in the Cardi-O-fix PFO occluder group. One reverted spontaneously to sinus rhythm and the other 2 cases had pharmacologic conversion to sinus rhythm. One case of paroxysmal atrial fibrillation occurred in the Amplatzer group, which underwent pharmacologic conversion to sinus rhythm. There was no significant difference between the 2 groups regarding incidence of arrhythmia. No occluder translocation, erosion, pericardial effusion, and puncture site bleeding were observed in the 2 groups within 12 months of follow-up. The complete closure rates of the Cardi-O-fix and Amplatzer PFO occluder devices at the 12 months after the

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

PubMed

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

2006-08-01

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

Evaluation of innovative devices to control traffic entering from low-volume access points within a land closure.

DOT National Transportation Integrated Search

2014-04-01

This report describes the methodology and results of analyses performed to identify and evaluate : alternative methods to control traffic entering a lane closure on a two-lane, two-way road from low-volume : access points. Researchers documented the ...

100-D Ponds closure plan. Revision 1

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

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 ismore » 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.« less

40 CFR 265.404 - Closure.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., Physical, and Biological Treatment § 265.404 Closure. At closure, all hazardous waste and hazardous waste residues must be removed from treatment processes or equipment, discharge control equipment, and discharge...

40 CFR 265.404 - Closure.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., Physical, and Biological Treatment § 265.404 Closure. At closure, all hazardous waste and hazardous waste residues must be removed from treatment processes or equipment, discharge control equipment, and discharge...

40 CFR 265.404 - Closure.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., Physical, and Biological Treatment § 265.404 Closure. At closure, all hazardous waste and hazardous waste residues must be removed from treatment processes or equipment, discharge control equipment, and discharge...

40 CFR 265.404 - Closure.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., Physical, and Biological Treatment § 265.404 Closure. At closure, all hazardous waste and hazardous waste residues must be removed from treatment processes or equipment, discharge control equipment, and discharge...

40 CFR 265.404 - Closure.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., Physical, and Biological Treatment § 265.404 Closure. At closure, all hazardous waste and hazardous waste residues must be removed from treatment processes or equipment, discharge control equipment, and discharge...

Effect of Permanent Right Internal Mammary Artery Closure on Coronary Collateral Function and Myocardial Ischemia.

PubMed

Stoller, Michael; Seiler, Christian

2017-06-01

The objective of this study is to test the effect of permanent right internal mammary artery device closure on coronary collateral function and myocardial ischemia. This was a prospective, open-label clinical trial in 50 patients with coronary artery disease. The primary study end point was coronary collateral flow index as obtained during a 1-minute proximal right coronary artery (RCA) and left coronary artery balloon occlusion at baseline before and at follow-up examination 6 weeks after distal right internal mammary artery device closure. Collateral flow index is the ratio between simultaneously recorded mean coronary occlusive pressure divided by mean aortic pressure, both subtracted by central venous pressure. Secondary study end points were fractional flow reserve during vessel patency, the quantitative intracoronary ECG ST-segment elevation, and angina pectoris during the same 1-minute coronary occlusion. Collateral flow index in the untreated RCA and left coronary artery changed from 0.071±0.082 at baseline to 0.132±0.117 ( P <0.0001) at follow-up examination and from 0.106±0.092 to 0.081±0.079 ( P =0.29), respectively. RCA fractional flow reserve increased significantly ( P =0.0029) from baseline to follow-up examination, despite deferral of coronary intervention in all patients. There was a decrease in intracoronary ECG ST-elevation during RCA occlusion from baseline to follow-up examination ( P =0.0015); it did not change in the left coronary artery. Angina pectoris during RCA occlusion tended to occur in fewer patients at follow-up versus baseline examination ( P =0.06). Permanent right internal mammary artery device closure seems to augment extracardiac ipsilateral coronary supply to the effect of reducing ischemia in the dependent myocardial region. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02475408. © 2017 The Authors.

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

PubMed

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

2013-11-15

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

Pressure-tight closure for thermoelements

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

Not Available

1937-06-14

The thermoelements were arranged in a pressure-tight housing for measuring temperatures on the inside of high-pressure hydrogenation equipment. Should the housing ever leak due to failure of the material or the grinding action of the high sand content of the coal paste, the stall was liable to be set on fire. If, in an installation protected in this manner, an element housing should leak, the pressure tight closure at one end of the housing prevented an escape of the gas and product and the stall could continue to run without danger. The final form of this closure was discussed inmore » detail in this report. In the development of this closure, particular value was attached to a compact construction. In the sealing for a 30-mm high pressure tube, four steel and four constantan wires were insulated and arranged pressure-tight. Each of the three fillers had a different purpose. The hard-rubber insert took the surface pressure, the rubber stopper provided a seal and the cast gypsum provided protection against heat should hot gas or product reach the closure in case of a leaky housing. Two drawings were given showing the thermoelement-closure, and the final form of the closure. The report discussed methods of evacuating from the thermohousings any accumulations of condensed water, which could damage insulation, or hydrogen, which continually diffused in small amounts during operation and which could attack the iron elements of the thermocouples. The pressure-tight closures for thermoelements had been successful at preventing fires due to leakage for more than nine months of operation. 2 sketches.« less

Percutaneous closure of patent foramen ovale in patients with presumed paradoxical embolism: periprocedural results and midterm risk of recurrent neurologic events.

PubMed

Balbi, Manrico; Casalino, Laura; Gnecco, Giovanni; Bezante, Gian Paolo; Pongiglione, Giacomo; Marasini, Maurizio; Del Sette, Massimo; Barsotti, Antonio

2008-08-01

To report our data on selected patients with previous paradoxical embolism who underwent transcatheter patent foramen ovale (PFO) closure. Between July 2001 and July 2007, percutaneous PFO closure was performed on 128 patients (65 women, mean age: 46 +/- 12.8 years). Patent foramen ovale closure was recommended for secondary prevention in patients with previous transient ischemic attacks (52.5%), stroke (46%), or peripheral embolism (1.5%). Implantation was successful in all patients, and at the end of intervention, complete PFO closure was achieved in 70.3% of them. There were no "major" complications (ie, deaths, device embolization or thrombosis, need for cardiac surgery). The overall incidence of complications (mostly hemorrhagic) was 7%. The mean follow-up period was 32 months. Complete closure had been achieved in 78.4% and in 82.5% of patients at the third month of transesophageal echocardiography examination and at the sixth month of transcranial Doppler examination, respectively. There were no recurrent thromboembolic events during the follow-up period. Percutaneous closure of PFO is a feasible procedure, but it is not a risk-free technique. However, in correctly selected patients (ie, large PFO and those at risk for neurologic relapse), nearly complete PFO closure seems to provide protection from future neurologic ischaemic events at midterm follow-up.

50 CFR 648.161 - Closures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Bluefish Fishery § 648.161 Closures. (a) EEZ closure. NMFS shall close the EEZ to fishing for bluefish by... dealer permit holders that no commercial quota is available for landing bluefish in that state. ...

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

PubMed Central

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

2018-01-01

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

Mitigation of infectious disease at school: targeted class closure vs school closure.

PubMed

Gemmetto, Valerio; Barrat, Alain; Cattuto, Ciro

2014-12-31

School environments are thought to play an important role in the community spread of infectious diseases such as influenza because of the high mixing rates of school children. The closure of schools has therefore been proposed as an efficient mitigation strategy. Such measures come however with high associated social and economic costs, making alternative, less disruptive interventions highly desirable. The recent availability of high-resolution contact network data from school environments provides an opportunity to design models of micro-interventions and compare the outcomes of alternative mitigation measures. We model mitigation measures that involve the targeted closure of school classes or grades based on readily available information such as the number of symptomatic infectious children in a class. We focus on the specific case of a primary school for which we have high-resolution data on the close-range interactions of children and teachers. We simulate the spread of an influenza-like illness in this population by using an SEIR model with asymptomatics, and compare the outcomes of different mitigation strategies. We find that targeted class closure affords strong mitigation effects: closing a class for a fixed period of time--equal to the sum of the average infectious and latent durations--whenever two infectious individuals are detected in that class decreases the attack rate by almost 70% and significantly decreases the probability of a severe outbreak. The closure of all classes of the same grade mitigates the spread almost as much as closing the whole school. Our model of targeted class closure strategies based on readily available information on symptomatic subjects and on limited information on mixing patterns, such as the grade structure of the school, shows that these strategies might be almost as effective as whole-school closure, at a much lower cost. This may inform public health policies for the management and mitigation of influenza

Catheter Closure Through a Venous Approach of Patent Ductus Arteriosus in Small Pediatric Patients Using Combined Angiographic and Echocardiographic Guidance.

PubMed

Thanopoulos, Basil Vasilios D; Ninios, Vlassis; Dardas, Petros; Giannopoulos, Andreas; Deleanou, Dan; Iancovici, Silvia

2016-11-15

The standard technique of catheter closure of patent ductus arteriosus (PDA) may be associated with arterial complications particularly in small pediatric patients. The aim of this study was to evaluate whether catheter closure of PDA in small children using an exclusive venous approach is a safe and effective alternative to closure with the standard technique. One hundred-twelve patients, aged 2 to 24 months, were randomly assigned in a 1:1 ratio to catheter closure of PDA using the standard technique (group 1) and an exclusive venous approach (group 2), respectively. In group 2, the procedure was guided using hand injections of contrast media through the delivery sheath and 2-dimensional and color Doppler echocardiography. Group 1: the PDA diameter ranged from 2 to 5.5 mm and the device diameter ranged from 4 to 8 mm. The PDA occluders were permanently implanted in all patients. Five losses of the arterial pulses that were restored with intravenous infusion of heparin and recombinant tissue plasminogen activator (rtPA), and 4 groin hematomas were the main complications of the procedure. Group 2: the mean PDA diameter ranged from 2.5 to 6 mm and the device diameter ranged from 3 to 8 mm. The PDA occluders were permanently implanted in all but 2 patients. There were no complications. Complete echocardiographic closure of PDA at 1-month follow-up was observed in all 110 patients. Exclusive transvenous PDA occlusion is an effective and safe technique that prevents the arterial complications of the standard approach in small children. Copyright © 2016 Elsevier Inc. All rights reserved.

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

PubMed Central

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

2016-01-01

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

Ethnic differences in primary angle-closure glaucoma.

PubMed

Yip, Jennifer L Y; Foster, Paul J

2006-04-01

Observational studies from different countries have shown that populations of East Asian origin have a higher frequency of primary angle-closure glaucoma compared with those of European or African descent. As half of all cases of glaucoma reside in Asia, and with primary angle-closure glaucoma carrying a higher rate of visual morbidity, primary angle-closure glaucoma poses an important public health problem; however, the inconsistent use of techniques and definitions to detect and diagnose primary angle-closure glaucoma has resulted in difficulties in interpreting the accuracy and comparability of such data. Therefore it is important to review these studies in the light of a consistent classification system. There are increasing reports that support previous findings on the incidence and prevalence of primary angle-closure glaucoma in different ethnic groups. There have also been further investigations into the mechanism and natural history of primary angle-closure glaucoma in Asian populations. International investigations into primary angle-closure glaucoma have demonstrated reproducible evidence that ethnic variations do exist. Cross-sectional studies in this area have also suggested that differences in anterior chamber depth, together with its association with peripheral anterior synechiae, may be part of the underlying mechanism behind these differences. The ideas generated need to be further explored with longitudinal data of changes in anterior chamber depth and peripheral anterior synechiae in different populations. The detailed mechanisms behind the development of angle-closure and primary angle-closure glaucoma should also be investigated.

Ratio-driven resuscitation predicts early fascial closure in the combat wounded.

PubMed

Glaser, Jacob; Vasquez, Matthew; Cardarelli, Cassandra; Dunne, James; Elster, Eric; Hathaway, Emily; Bograd, Benjamin; Safford, Shawn; Rodriguez, Carlos

2015-10-01

Operation Iraqi Freedom and Operation Enduring Freedom have seen the highest rates of combat casualties since Vietnam. These casualties often require massive transfusion (MT) and immediate surgical attention to control hemorrhage. Clinical practice guidelines dictate ratio-driven resuscitation (RDR) for patients requiring MT. With the transition from crystalloid to blood product resuscitation, we have seen fewer open abdomens in combat casualties. We sought to determine the effect RDR has on achieving early definitive abdominal fascial closure in combat casualties undergoing exploratory laparotomy. Records of 1,977 combat casualties admitted to a single US military hospital from April 2003 to December 2011 were reviewed. Patients receiving an MT and laparotomy in theater constituted the study cohort. The cohort was divided into RDR, defined as a ratio of 0.8-U to 1.2-U packed red blood cells to 1-U fresh frozen plasma, and No-RDR groups. Age, injury patterns, mechanism of injury, injury severity, blood products, number of laparotomies, and days to fascial closure were collected. Assessed outcomes were number of days (early ≤ 2 days) and number of laparotomies to achieve fascial closure. The mean age of the study cohort (n = 172) was 24.0 years, and mean Injury Severity Score (ISS) was 24.8. Improvised explosive device blast was the most common mechanism of injury (74.4%). The cohort was divided into RDR patients (n = 73) and no RDR (n = 99). There was no difference in mean age, mean ISS, or rate of nontherapeutic exploratory laparotomies between the groups. RDR patients had a significantly lower abdominal injury rate (34.2% vs. 72.7%, p < 0.01), had fewer laparotomies (2.7 vs. 4.3, p = 0.003), and achieved primary fascial closure faster (2.4 days vs. 7.2 days, p = 0.004). On multivariate analysis, RDR (2.74; 95% confidence interval, 1.44-5.2) was an independent predictor for early fascial closure. Adherence to RDR guidelines resulted in significantly decreased

Temporary Abdominal Closure Combined With an Irrigating System Utilizing Hypochlorous Acid Solution to Decrease Abdominal Mucopurulence

PubMed Central

Matthews, Marc R.; Quan, Asia N.; Weir, Alexandra S.; Foster, Kevin N.; Caruso, Daniel M.

2018-01-01

Introduction: Leaving the abdominal cavity open is a well-described and frequently utilized technique in the treatment of severe intra-abdominal sepsis. Irrigation through a negative pressure wound therapy device is a technique employed to assist in the closure of wounds as well as the reduction of bacterial contamination. Furthermore, hypochlorous acid has been found to be safe and effective in microorganismal elimination from extremity wounds. There is no literature regarding the infusion of hypochlorous solution into the abdominal cavity for intra-abdominal sepsis or mucopurulent abscesses or biofilm. Objectives: A 47-year-old man with granulomatosis polyangiitis was started on weekly rituximab. After 4 infusions, skin sloughing, ultimately diagnosed as toxic epidermal necrolysis, developed. During the hospital course, he developed sepsis and bowel perforation necessitating an exploratory laparotomy. The abdomen was left open with a temporary abdominal closure using the Abthera open abdomen negative wound therapy device; however, the abdomen remained infected with visually diffuse, thickening mucopurulence despite multiple washouts. Therefore, a VAC Vera-Flo irrigation device was combined with the Abthera open abdomen negative wound therapy device and cyclical irrigation of hypochlorous acid. After 72 hours, the purulence visually was improved and no adverse events were recorded with the placement of intra-abdominal hypochlorous acid. Conclusions: The combination of two medical devices for the intra-abdominal instillation of irrigation is considered “off-label use” from the manufacturer's recommendations. In addition, the repeated instillation of hypochlorous acid solution has not been described but was noted to have visually decreased the contaminated effluent within the intra-abdominal fluid. PMID:29527250

32 CFR 989.25 - Base closure and realignment.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 6 2013-07-01 2013-07-01 false Base closure and realignment. 989.25 Section 989... PROTECTION ENVIRONMENTAL IMPACT ANALYSIS PROCESS (EIAP) § 989.25 Base closure and realignment. Base closure or realignment may entail special requirements for environmental analysis. The permanent base closure...

32 CFR 989.25 - Base closure and realignment.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 6 2012-07-01 2012-07-01 false Base closure and realignment. 989.25 Section 989... PROTECTION ENVIRONMENTAL IMPACT ANALYSIS PROCESS (EIAP) § 989.25 Base closure and realignment. Base closure or realignment may entail special requirements for environmental analysis. The permanent base closure...

Evaluation of the Momentum Closure Schemes in MPAS-Ocean

NASA Astrophysics Data System (ADS)

Zhao, Shimei; Liu, Yudi; Liu, Wei

2018-04-01

In order to compare and evaluate the performances of the Laplacian viscosity closure, the biharmonic viscosity closure, and the Leith closure momentum schemes in the MPAS-Ocean model, a variety of physical quantities, such as the relative reference potential energy (RPE) change, the RPE time change rate (RPETCR), the grid Reynolds number, the root mean square (RMS) of kinetic energy, and the spectra of kinetic energy and enstrophy, are calculated on the basis of results of a 3D baroclinic periodic channel. Results indicate that: 1) The RPETCR demonstrates a saturation phenomenon in baroclinic eddy tests. The critical grid Reynolds number corresponding to RPETCR saturation differs between the three closures: the largest value is in the biharmonic viscosity closure, followed by that in the Laplacian viscosity closure, and that in the Leith closure is the smallest. 2) All three closures can effectively suppress spurious dianeutral mixing by reducing the grid Reynolds number under sub-saturation conditions of the RPETCR, but they can also damage certain physical processes. Generally, the damage to the rotation process is greater than that to the advection process. 3) The dissipation in the biharmonic viscosity closure is strongly dependent on scales. Most dissipation concentrates on small scales, and the energy of small-scale eddies is often transferred to large-scale kinetic energy. The viscous dissipation in the Laplacian viscosity closure is the strongest on various scales, followed by that in the Leith closure. Note that part of the small-scale kinetic energy is also transferred to large-scale kinetic energy in the Leith closure. 4) The characteristic length scale L and the dimensionless parameter D in the Leith closure are inherently coupled. The RPETCR is inversely proportional to the product of D and L. When the product of D and L is constant, both the simulated RPETCR and the inhibition of spurious dianeutral mixing are the same in all tests using the Leith

Umbilical hernia following gastroschisis closure: a common event?

PubMed

Tullie, L G C; Bough, G M; Shalaby, A; Kiely, E M; Curry, J I; Pierro, A; De Coppi, P; Cross, K M K

2016-08-01

To assess incidence and natural history of umbilical hernia following sutured and sutureless gastroschisis closure. With audit approval, we undertook a retrospective clinical record review of all gastroschisis closures in our institution (2007-2013). Patient demographics, gastroschisis closure method and umbilical hernia occurrence were recorded. Data, presented as median (range), underwent appropriate statistical analysis. Fifty-three patients were identified, gestation 36 weeks (31-38), birth weight 2.39 kg (1-3.52) and 23 (43 %) were male. Fourteen patients (26 %) underwent sutureless closure: 12 primary, 2 staged; and 39 (74 %) sutured closure: 19 primary, 20 staged. Sutured closure was interrupted sutures in 24 patients, 11 pursestring and 4 not specified. Fifty patients were followed-up over 53 months (10-101) and 22 (44 %) developed umbilical hernias. There was a significantly greater hernia incidence following sutureless closure (p = 0.0002). In sutured closure, pursestring technique had the highest hernia rate (64 %). Seven patients underwent operative hernia closure; three secondary to another procedure. Seven patients had their hernias resolve. One patient was lost to follow-up and seven remain under observation with no reported complications. There is a significant umbilical hernia incidence following sutureless and pursestring sutured gastroschisis closure. This has not led to complications and the majority have not undergone repair.

Percutaneous closure of acute aorto-right ventricular fistula following transcatheter bicuspid aortic valve replacement.

PubMed

Nakamura, Kenta; Passeri, Jonathan J; Inglessis-Azuaje, Ignacio

2017-07-01

We report a case of acute aorto-right ventricular fistula following transcatheter bicuspid aortic valve replacement and subsequent percutaneous closure. The diagnosis and treatment of this rare complication is illustrated through multi-modality imaging. We hypothesize that the patient's heavily calcified bicuspid aortic valve anatomy led to asymmetric deployment of the transcatheter aortic valve replacement (TAVR) prosthesis, traumatizing the right sinus of Valsalva at the distal edge of the TAVR stent and ultimately fistulized to the right ventricle. The patient acutely decompensated with heart failure five days after TAVR and underwent emergent intervention. The aorto-right ventricular fistula was closed using an 18-mm septal occluder device with marked clinical recovery. Transcatheter closure is a viable treatment option for acute aorto-right ventricular fistula. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

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.

Effects of supplemental vibrational force on space closure, treatment duration, and occlusal outcome: A multicenter randomized clinical trial.

PubMed

DiBiase, Andrew T; Woodhouse, Neil R; Papageorgiou, Spyridon N; Johnson, Nicola; Slipper, Carmel; Grant, James; Alsaleh, Maryam; Khaja, Yousef; Cobourne, Martyn T

2018-04-01

A multicenter parallel 3-arm randomized clinical trial was carried out in 3 university hospitals in the United Kingdom to investigate the effect of supplemental vibratory force on space closure and treatment outcome with fixed appliances. Eighty-one subjects less than 20 years of age with mandibular incisor irregularity undergoing extraction-based fixed appliance treatment were randomly allocated to supplementary (20 minutes/day) use of an intraoral vibrational device (AcceleDent; OrthoAccel Technologies, Houston, Tex) (n = 29), an identical nonfunctional (sham) device (n = 25), or fixed-appliance only (n = 27). Space closure in the mandibular arch was measured from dental study casts taken at the start of space closure, at the next appointment, and at completion of space closure. Final records were taken at completion of treatment. Data were analyzed blindly on a per-protocol basis with descriptive statistics, 1-way analysis of variance, and linear regression modeling with 95% confidence intervals. Sixty-one subjects remained in the trial at start of space closure, with all 3 groups comparable for baseline characteristics. The overall median rate of initial mandibular arch space closure (primary outcome) was 0.89 mm per month with no difference for either the AcceleDent group (difference, -0.09 mm/month; 95% CI, -0.39 to 0.22 mm/month; P = 0.57) or the sham group (difference, -0.02 mm/month; 95% CI, -0.32 to 0.29 mm/month; P = 0.91) compared with the fixed only group. Similarly, no significant differences were identified between groups for secondary outcomes, including overall treatment duration (median, 18.6 months; P >0.05), number of visits (median, 12; P >0.05), and percentage of improvement in the Peer Assessment Rating (median, 90.0%; P >0.05). Supplemental vibratory force during orthodontic treatment with fixed appliances does not affect space closure, treatment duration, total number of visits, or final occlusal outcome. NCT02314975

Is transcatheter closure better than medical therapy for cryptogenic stroke with patent foramen ovale? A meta-analysis of randomised trials.

PubMed

Nagaraja, Vinayak; Raval, Jwalant; Eslick, Guy D; Burgess, David; Denniss, A Robert

2013-11-01

The prevalence of patent foramen ovale among patients with cryptogenic stroke is higher than that in the general population. Closure with a percutaneous device is often recommended in such patients, but it is not known whether this intervention reduces the risk of recurrent stroke. A systematic search was conducted using MEDLINE, PubMed, EMBASE, Current Contents Connect, Cochrane library, Google Scholar, Science Direct, and Web of Science. Original data were abstracted from each study and used to calculate a pooled event rate (ER), odd ratio (OR) and 95% confidence interval (95% CI). Only three randomised trials comprising 2303 patients met full criteria for analysis. Procedural success (ER: 94.20%, 95% CI: 87.6-97.4%) and effective closure (ER: 92.70%, 95% CI: 85.9-96.4%) of closure therapy were good. The odds ratio for stroke (OR: 0.654, 95% CI: 0.358-1.193) and transient ischaemic attack (OR: 0.768, 95% CI: 0.413-1.429) did not confer a benefit of PFO closure over medical therapy. Age {<45 years (OR: 0.449, 95% CI: 0.117-1.722), >45 years (OR: 0.707, 95% CI: 0.27-1.856)}, gender {males (OR: 0.498, 95% CI: 0.247-1.004), females (OR: 1.16, 95% CI: 0.597-2.255)}, substantial shunt size (OR: 0.354, 95% CI: 0.089-1.406) and the presence of atrial septal aneurysm (OR: 0.7, 95% CI: 0.21-2.33) did not influence the treatment effect of PFO closure. However, the adverse events like major vascular complication (OR: 10.905, 95% CI: 1.997-59.562) and atrial fibrillation (OR: 3.297, 95% CI: 0.874-12.432) were significantly higher in the closure group. In patients with cryptogenic stroke or TIA who had a patent foramen ovale, closure with a device does not confer an advantage over medical therapy and is associated with adverse events like major vascular complication and atrial fibrillation. Copyright © 2013 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). All rights reserved.

Three point-advancement closure for skin defects.

PubMed

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

1999-10-01

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

Barbed suture material technique for wound closure and concomitant tube placement in uniportal VATS for pneumothorax

PubMed Central

2017-01-01

Background Uniportal video-assisted thoracoscopic surgery (VATS) is an alternative modality for treatment of primary spontaneous pneumothorax (PSP) with its less invasiveness and acceptable surgical outcomes. However, a few reports have been introduced for wound management to achieve better cosmetic wound healing and for placement of the chest tube in uniportal VATS. Thus, we aimed to evaluate the feasibility of our novel method for wound closure and concomitant tube placement using continuous barbed suture material in uniportal VATS for PSP. Methods Between July 2012 and December 2015, consecutive 31 patients (22 males) underwent uniportal VATS to treat PSP. Bilateral approaches were performed in four patients, thus total 35 cases were enrolled. We divided them into two groups with one group of 17 (48.5%) cases (group A), using barbed absorbable wound closure device for knotless continuous wound closure and subsequent chest tube anchoring, and the other group of 18 (51.4%) cases (group B), using conventional suture anchoring after skin closure using absorbable suture device. Postoperative surgical outcomes were compared to assess the feasibility of this technique. Results Demographic data demonstrate no significant difference in both groups. There was no significant difference in length of hospital stay (3.7±1.2 vs. 4.1±1.2 days, P=0.267) and in median chest tube indwelling time (2.4±0.9 vs. 3.1±1.2 days, P=0.066), respectively. Operation time in group A was shorter than in group B but there was no significant difference (41.7±11.8 vs. 45.6±16.0 minutes, P=0.415). There was neither conversion to two or three port VATS in all cases. In group A, all chest tubes were removed with concomitant sealing the tube removal site by pulling the thread. Residual knots do not exist that stitch out procedure is not required. There was no wound complication in both groups during the median follow-up period of 18 months. Conclusions Knotless, barbed suture material technique

Percutaneous Closure of Patent Foramen Ovale in Patients With Migraine: The PREMIUM Trial.

PubMed

Tobis, Jonathan M; Charles, Andrew; Silberstein, Stephen D; Sorensen, Sherman; Maini, Brijeshwar; Horwitz, Phillip A; Gurley, John C

2017-12-05

Migraine is a prevalent and disabling disorder. Patent foramen ovale (PFO) has been associated with migraine, but its role in the disorder remains poorly understood. This study examined the efficacy of percutaneous PFO closure as a therapy for migraine with or without aura. The PREMIUM (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management) was a double-blind study investigating migraine characteristics over 1 year in subjects randomized to medical therapy with a sham procedure (right heart catheterization) versus medical therapy and PFO closure with the Amplatzer PFO Occluder device (St. Jude Medical, St. Paul, Minnesota). Subjects had 6 to 14 days of migraine per month, had failed at least 3 migraine preventive medications, and had significant right-to-left shunt defined by transcranial Doppler. Primary endpoints were responder rate defined as 50% reduction in migraine attacks and adverse events. Secondary endpoints included reduction in migraine days and efficacy in patients with versus without aura. Of 1,653 subjects consented, 230 were enrolled. There was no difference in responder rate in the PFO closure (45 of 117) versus control (33 of 103) groups. One serious adverse event (transient atrial fibrillation) occurred in 205 subjects who underwent PFO closure. Subjects in the PFO closure group had a significantly greater reduction in headache days (-3.4 vs. -2.0 days/month, p = 0.025). Complete migraine remission for 1 year occurred in 10 patients (8.5%) in the treatment group versus 1 (1%) in the control group (p = 0.01). PFO closure did not meet the primary endpoint of reduction in responder rate in patients with frequent migraine. (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management [PREMIUM]; NCT00355056). Copyright

Do we need a femoral artery route for transvenous PDA closure in children with ADO-I?

PubMed

Baykan, Ali; Narin, Nazmi; Özyurt, Abdullah; Argun, Mustafa; Pamukçu, Özge; Onan, Sertaç H; Sezer, Sadettin; Baykan, Zeynep; Üzüm, Kazım

2015-03-01

The standard procedure in percutaneous closure of patent ductus arteriosus (PDA) with Amplatzer duct occluder-I (ADO-I) is transvenous closure guided by aortic access through femoral artery. The current study aims to compare the procedures for PDA closure with ADO-I: only transvenous access with the standard procedure. This study was designed retrospectively and 101 pediatric patients were included. PDA closure was done by only femoral venous access in 19 of them (group 1), arterial and venous access used in 92 patients (group 2) between 2004 to 2012 years. The position of the device and residual shunt in group1 was evaluated by the guidance of the aortogram obtained during the return phase of the pulmonary artery injection and guidance of transthoracic echocardiography. Shapiro-Wilk's test, Mann-Whitney U, chi-squared tests were used for statistical comparison. The procedure was successful in 18 (95%) patients in group 1 and 90 (98%) patients in group 2. Complications including the pulmonary artery embolization (n=1), protrusion to pulmonary artery (n=1), inguinal hematoma (n=3), bleeding (n=2) were only detected in group 2. In other words, while complications were observed in 7 (7.2%) patients in group 2, no minor/major complication was observed in group 1. Complete closure in group 1 was: in catheterization room 14 (77.8%), at 24th hour in 2 (11.1%), at first month in 2 (11.1%). Complete closure in group 2 was: 66 (73.4%) patients in the catheterization room, 21 (23.3%) at 24th hour, 3 (3.3%) at first month, complete closure occurred at the end of first month. In percutaneouse PDA closure via ADO-I, this technique can be a choice for patients whose femoral artery could not be accessed, or access is impossible/contraindicated. But for the reliability and validity of this method, randomized multicenter clinical studies are necessary.

Do we need a femoral artery route for transvenous PDA closure in children with ADO-I?

PubMed Central

Baykan, Ali; Narin, Nazmi; Özyurt, Abdullah; Argun, Mustafa; Pamukçu, Özge; Onan, Sertaç H.; Sezer, Sadettin; Baykan, Zeynep; Üzüm, Kazım

2015-01-01

Objective: The standard procedure in percutaneous closure of patent ductus arteriosus (PDA) with Amplatzer duct occluder-I (ADO-I) is transvenous closure guided by aortic access through femoral artery. The current study aims to compare the procedures for PDA closure with ADO-I: only transvenous access with the standard procedure. Methods: This study was designed retrospectively and 101 pediatric patients were included. PDA closure was done by only femoral venous access in 19 of them (group 1), arterial and venous access used in 92 patients (group 2) between 2004 to 2012 years. The position of the device and residual shunt in group1 was evaluated by the guidance of the aortogram obtained during the return phase of the pulmonary artery injection and guidance of transthoracic echocardiography. Shapiro-Wilk’s test, Mann-Whitney U, chi-squared tests were used for statistical comparison. Results: The procedure was successful in 18 (95%) patients in group 1 and 90 (98%) patients in group 2. Complications including the pulmonary artery embolization (n=1), protrusion to pulmonary artery (n=1), inguinal hematoma (n=3), bleeding (n=2) were only detected in group 2. In other words, while complications were observed in 7 (7.2%) patients in group 2, no minor/major complication was observed in group 1. Complete closure in group 1 was: in catheterization room 14 (77.8%), at 24th hour in 2 (11.1%), at first month in 2 (11.1%). Complete closure in group 2 was: 66 (73.4%) patients in the catheterization room, 21 (23.3%) at 24th hour, 3 (3.3%) at first month, complete closure occurred at the end of first month. Conclusion: In percutaneouse PDA closure via ADO-I, this technique can be a choice for patients whose femoral artery could not be accessed, or access is impossible/contraindicated. But for the reliability and validity of this method, randomized multicenter clinical studies are necessary. PMID:25333978

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

PubMed

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

2014-06-01

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. Published by Elsevier Ltd.

Anterior Segment Imaging for Angle Closure.

PubMed

Chansangpetch, Sunee; Rojanapongpun, Prin; Lin, Shan C

2018-04-01

To summarize the role of anterior segment imaging (AS-imaging) in angle closure diagnosis and management, and the possible advantages over the current standard of gonioscopy. Literature review and perspective. Review of the pertinent publications with interpretation and perspective in relation to the use of AS-imaging in angle closure assessment focusing on anterior segment optical coherence tomography and ultrasound biomicroscopy. Several limitations have been encountered with the reference standard of gonioscopy for angle assessment. AS-imaging has been shown to have performance in angle closure detection compared to gonioscopy. Also, imaging has greater reproducibility and serves as better documentation for long-term follow-up than conventional gonioscopy. The qualitative and quantitative information obtained from AS-imaging enables better understanding of the underlying mechanisms of angle closure and provides useful parameters for risk assessment and possible prediction of the response to laser and surgical intervention. The latest technologies-including 3-dimensional imaging-have allowed for the assessment of the angle that simulates the gonioscopic view. These advantages suggest that AS-imaging has a potential to be a reference standard for the diagnosis and monitoring of angle closure disease in the future. Although gonioscopy remains the primary method of angle assessment, AS-imaging has an increasing role in angle closure screening and management. The test should be integrated into clinical practice as an adjunctive tool for angle assessment. It is arguable that AS-imaging should be considered first-line screening for patients at risk for angle closure. Copyright © 2018 Elsevier Inc. All rights reserved.

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

Factors associated with increasing nursing home closures.

PubMed

Castle, Nicholas G; Engberg, John; Lave, Judith; Fisher, Andrew

2009-06-01

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. 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. 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. 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.

31 CFR 413.1 - Closure of streets.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 2 2012-07-01 2012-07-01 false Closure of streets. 413.1 Section 413.1 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) SECRET SERVICE, DEPARTMENT OF THE TREASURY CLOSURE OF STREETS NEAR THE WHITE HOUSE § 413.1 Closure of streets. (a) District...

31 CFR 413.1 - Closure of streets.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 2 2013-07-01 2013-07-01 false Closure of streets. 413.1 Section 413.1 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) SECRET SERVICE, DEPARTMENT OF THE TREASURY CLOSURE OF STREETS NEAR THE WHITE HOUSE § 413.1 Closure of streets. (a) District...

31 CFR 413.1 - Closure of streets.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 2 2011-07-01 2011-07-01 false Closure of streets. 413.1 Section 413.1 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) SECRET SERVICE, DEPARTMENT OF THE TREASURY CLOSURE OF STREETS NEAR THE WHITE HOUSE § 413.1 Closure of streets. (a) District...

31 CFR 413.1 - Closure of streets.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 2 2010-07-01 2010-07-01 false Closure of streets. 413.1 Section 413.1 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) SECRET SERVICE, DEPARTMENT OF THE TREASURY CLOSURE OF STREETS NEAR THE WHITE HOUSE § 413.1 Closure of streets. (a) District...

31 CFR 413.1 - Closure of streets.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance: Treasury 2 2014-07-01 2014-07-01 false Closure of streets. 413.1 Section 413.1 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) SECRET SERVICE, DEPARTMENT OF THE TREASURY CLOSURE OF STREETS NEAR THE WHITE HOUSE § 413.1 Closure of streets. (a) District...

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

... Closure, Target Shooting Public Safety Closure on the Lake Mountains in Utah County, UT AGENCY: Bureau of... Lake Mountains in Utah County, Utah, to recreational target shooting to protect public safety. This... shooting closure within the described area will remain in effect no longer than two years from December 19...

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.

Anterior Segment Imaging Predicts Incident Gonioscopic Angle Closure.

PubMed

Baskaran, Mani; Iyer, Jayant V; Narayanaswamy, Arun K; He, Yingke; Sakata, Lisandro M; Wu, Renyi; Liu, Dianna; Nongpiur, Monisha E; Friedman, David S; Aung, Tin

2015-12-01

To investigate the incidence of gonioscopic angle closure after 4 years in subjects with gonioscopically open angles but varying degrees of angle closure detected on anterior segment optical coherence tomography (AS OCT; Visante; Carl Zeiss Meditec, Dublin, CA) at baseline. Prospective, observational study. Three hundred forty-two subjects, mostly Chinese, 50 years of age or older, were recruited, of whom 65 were controls with open angles on gonioscopy and AS OCT at baseline, and 277 were cases with baseline open angles on gonioscopy but closed angles (1-4 quadrants) on AS OCT scans. All subjects underwent gonioscopy and AS OCT at baseline (horizontal and vertical single scans) and after 4 years. The examiner performing gonioscopy was masked to the baseline and AS OCT data. Angle closure in a quadrant was defined as nonvisibility of the posterior trabecular meshwork by gonioscopy and visible iridotrabecular contact beyond the scleral spur in AS OCT scans. Gonioscopic angle closure in 2 or 3 quadrants after 4 years. There were no statistically significant differences in age, ethnicity, or gender between cases and controls. None of the control subjects demonstrated gonioscopic angle closure after 4 years. Forty-eight of the 277 subjects (17.3%; 95% confidence interval [CI], 12.8-23; P < 0.0001) with at least 1 quadrant of angle closure on AS OCT at baseline demonstrated gonioscopic angle closure in 2 or more quadrants, whereas 28 subjects (10.1%; 95% CI, 6.7-14.6; P < 0.004) demonstrated gonioscopic angle closure in 3 or more quadrants after 4 years. Individuals with more quadrants of angle closure on baseline AS OCT scans had a greater likelihood of gonioscopic angle closure developing after 4 years (P < 0.0001, chi-square test for trend for both definitions of angle closure). Anterior segment OCT imaging at baseline predicts incident gonioscopic angle closure after 4 years among subjects who have gonioscopically open angles and iridotrabecular contact on AS OCT at

Rubber closures for freeze-dried products.

PubMed

Hopkins, G H

1976-10-01

Once a biological product has been developed to perform its required medical or pharmaceutical function, it is essential that a container-closure system by chosen which will preserve the efficacy of the product up to the point of administration. The general requirements applicable to proper closure function will be reviewed and the suitability of natural and synthetic elastomers to perform these functions will be discussed. The specialized application of elastomeric materials as closures for freeze-dried products presents additional requirements which are superimposed upon those previously discussed. The first of these unique considerations relates to the proper physical design which will permit the outgassing of water vapor during the sublimation step in the lyophilizing chamber. During this outgassing the design must also permit the closure to remain affixed in the neck while only partially inserted. Since these preparations are lyophilized because they are unstable in aqueous solutions, the elastomer used must constitute an effective barrier to the transmission of moisture vapor through the closure. The MVT and gas transmission properties of elastomers will be discussed. Special consideration will be given to the extremely low temperatures used in the sublimation, stoppering, and storage before use of lyophilized products. The phenomenon of glass transition points with different elastomers will be explained as its relation to satisfactory performance of the closure function at low temperatures.

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

PubMed

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

2015-03-01

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

Silicone absorption of elastomeric closures--an accelerated study.

PubMed

Degrazio, F L; Hlobik, T; Vaughan, S

1998-01-01

There is a trend in the parenteral industry to move from the use of elastomeric closures which are washed, siliconized, dried and sterilized in-house at the pharmaceutical manufacturers' site to pre-prepared closures purchased from the closure supplier. This preparation can consist of washing to reduce particle-load and bioburden, siliconization, placement in ready-to-sterilize bags and may eventually extend to sterilization by steam autoclave or gamma irradiation. Since silicone oil lubrication is critical to the processability/machinability of closures, research was designed to investigate this phenomenon in closures prepared using the Westar RS (Ready-to-Sterilize) process. This paper presents the data gathered in a study of the characteristic of silicone absorption into elastomeric closures under accelerated conditions. Variables such as silicone viscosity, rubber formulation, effect of sterilization and others are considered.

Randomized clinical trial of intestinal ostomy takedown comparing pursestring wound closure vs conventional closure to eliminate the risk of wound infection.

PubMed

Camacho-Mauries, Daniel; Rodriguez-Díaz, José Luis; Salgado-Nesme, Noel; González, Quintín H; Vergara-Fernández, Omar

2013-02-01

The use of temporary stomas has been demonstrated to reduce septic complications, especially in high-risk anastomosis; therefore, it is necessary to reduce the number of complications secondary to ostomy takedowns, namely wound infection, anastomotic leaks, and intestinal obstruction. To compare the rates of superficial wound infection and patient satisfaction after pursestring closure of ostomy wound vs conventional linear closure. Patients undergoing colostomy or ileostomy closure between January 2010 and February 2011 were randomly assigned to linear closure (n = 30) or pursestring closure (n = 31) of their ostomy wound. Wound infection within 30 days of surgery was defined as the presence of purulent discharge, pain, erythema, warmth, or positive culture for bacteria. Patient satisfaction, healing time, difficulty managing the wound, and limitation of activities were analyzed with the Likert questionnaire. The infection rate for the control group was 36.6% (n = 11) vs 0% in the pursestring closure group (p < 0.0001). Healing time was 5.9 weeks in the linear closure group and 3.8 weeks in the pursestring group (p = 0.0002). Seventy percent of the patients with pursestring closure were very satisfied in comparison with 20% in the other group (p = 0.0001). This study was limited by the heterogeneity in the type of stoma in both groups. The pursestring method resulted in the absence of infection after ostomy wound closure (shorter healing time and improved patient satisfaction).

50 CFR 622.43 - Closures.

Code of Federal Regulations, 2012 CFR

2012-10-01

... following closure restrictions apply (See § 622.49 for closure provisions when an ACL is reached or... quota specified in § 622.42, or the ACL specified in 622.49, being reached and subsequent data indicate that the quota or ACL was not reached, the Assistant Administrator may file a notification to that...

Modeling of combined effects of divertor closure and advanced magnetic configuration on detachment in DIII-D by SOLPS

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

Si, Hang; Guo, Houyang Y.; Covele, Brent

One of the major challenges facing the design and operation of next-step high-power steady-state fusion devices is to develop a divertor solution for handling power exhaust, while ensuring acceptable divertor target plate erosion, which necessitates access to divertor detachment at relative low main plasma densities compatible with current drive and high plasma confinement. Detailed modeling with SOLPS is carried out to examine the effect of divertor closure on detachment with the normal single null divertor (SD) configuration, as well as one of the advanced divertor configurations, such as x-divertor (XD) respectively. The SOLPS modeling for a high confinement plasma in DIII-D finds that increasing divertor closure with SD reduces the upstream separatrix density at the onset of detachment frommore » $$1.18\\times {{10}^{19}}\\,{{{\\rm m}}^{-3}}$$ to $$0.88\\times {{10}^{19}}\\,{{{\\rm m}}^{-3}}$$. Furthermore, coupling the divertor closure with XD further promotes the onset of divertor detachment at a still lower upstream separatrix density, down to the value of $$0.67\\times {{10}^{19}}\\,{{{\\rm m}}^{-3}}$$, thus, showing that divertor closure and advanced magnetic configuration can work synergistically to facilitate divertor detachment.« less

Modeling of combined effects of divertor closure and advanced magnetic configuration on detachment in DIII-D by SOLPS

DOE PAGES

Si, Hang; Guo, Houyang Y.; Covele, Brent; ...

2018-04-04

One of the major challenges facing the design and operation of next-step high-power steady-state fusion devices is to develop a divertor solution for handling power exhaust, while ensuring acceptable divertor target plate erosion, which necessitates access to divertor detachment at relative low main plasma densities compatible with current drive and high plasma confinement. Detailed modeling with SOLPS is carried out to examine the effect of divertor closure on detachment with the normal single null divertor (SD) configuration, as well as one of the advanced divertor configurations, such as x-divertor (XD) respectively. The SOLPS modeling for a high confinement plasma in DIII-D finds that increasing divertor closure with SD reduces the upstream separatrix density at the onset of detachment frommore » $$1.18\\times {{10}^{19}}\\,{{{\\rm m}}^{-3}}$$ to $$0.88\\times {{10}^{19}}\\,{{{\\rm m}}^{-3}}$$. Furthermore, coupling the divertor closure with XD further promotes the onset of divertor detachment at a still lower upstream separatrix density, down to the value of $$0.67\\times {{10}^{19}}\\,{{{\\rm m}}^{-3}}$$, thus, showing that divertor closure and advanced magnetic configuration can work synergistically to facilitate divertor detachment.« less

Modeling of combined effects of divertor closure and advanced magnetic configuration on detachment in DIII-D by SOLPS

NASA Astrophysics Data System (ADS)

Si, H.; Guo, H. Y.; Covele, B.; Leonard, A. W.; Watkins, J. G.; Thomas, D.; Ding, R.

2018-05-01

One of the major challenges facing the design and operation of next-step high-power steady-state fusion devices is to develop a divertor solution for handling power exhaust, while ensuring acceptable divertor target plate erosion, which necessitates access to divertor detachment at relative low main plasma densities compatible with current drive and high plasma confinement. Detailed modeling with SOLPS is carried out to examine the effect of divertor closure on detachment with the normal single null divertor (SD) configuration, as well as one of the advanced divertor configurations, such as x-divertor (XD) respectively. The SOLPS modeling for a high confinement plasma in DIII-D finds that increasing divertor closure with SD reduces the upstream separatrix density at the onset of detachment from 1.18× {{10}19} {{m}-3} to 0.88× {{10}19} {{m}-3} . Moreover, coupling the divertor closure with XD further promotes the onset of divertor detachment at a still lower upstream separatrix density, down to the value of 0.67× {{10}19} {{m}-3} , thus, showing that divertor closure and advanced magnetic configuration can work synergistically to facilitate divertor detachment.

40 CFR 265.1202 - Closure and post-closure care.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., STORAGE, AND DISPOSAL FACILITIES Hazardous Waste Munitions and Explosives Storage § 265.1202 Closure and... as long as it remains in service as a munitions or explosives magazine or storage unit. (b) If, after...

40 CFR 265.1202 - Closure and post-closure care.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., STORAGE, AND DISPOSAL FACILITIES Hazardous Waste Munitions and Explosives Storage § 265.1202 Closure and... as long as it remains in service as a munitions or explosives magazine or storage unit. (b) If, after...

40 CFR 265.1202 - Closure and post-closure care.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., STORAGE, AND DISPOSAL FACILITIES Hazardous Waste Munitions and Explosives Storage § 265.1202 Closure and... as long as it remains in service as a munitions or explosives magazine or storage unit. (b) If, after...

40 CFR 265.1202 - Closure and post-closure care.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., STORAGE, AND DISPOSAL FACILITIES Hazardous Waste Munitions and Explosives Storage § 265.1202 Closure and... as long as it remains in service as a munitions or explosives magazine or storage unit. (b) If, after...

Some Recent Developments in Turbulence Closure Modeling

NASA Astrophysics Data System (ADS)

Durbin, Paul A.

2018-01-01

Turbulence closure models are central to a good deal of applied computational fluid dynamical analysis. Closure modeling endures as a productive area of research. This review covers recent developments in elliptic relaxation and elliptic blending models, unified rotation and curvature corrections, transition prediction, hybrid simulation, and data-driven methods. The focus is on closure models in which transport equations are solved for scalar variables, such as the turbulent kinetic energy, a timescale, or a measure of anisotropy. Algebraic constitutive representations are reviewed for their role in relating scalar closures to the Reynolds stress tensor. Seamless and nonzonal methods, which invoke a single closure model, are reviewed, especially detached eddy simulation (DES) and adaptive DES. Other topics surveyed include data-driven modeling and intermittency and laminar fluctuation models for transition prediction. The review concludes with an outlook.

Analysis of Mining-induced Valley Closure Movements

NASA Astrophysics Data System (ADS)

Zhang, C.; Mitra, R.; Oh, J.; Hebblewhite, B.

2016-05-01

Valley closure movements have been observed for decades in Australia and overseas when underground mining occurred beneath or in close proximity to valleys and other forms of irregular topographies. Valley closure is defined as the inward movements of the valley sides towards the valley centreline. Due to the complexity of the local geology and the interplay between several geological, topographical and mining factors, the underlying mechanisms that actually cause this behaviour are not completely understood. A comprehensive programme of numerical modelling investigations has been carried out to further evaluate and quantify the influence of a number of these mining and geological factors and their inter-relationships. The factors investigated in this paper include longwall positional factors, horizontal stress, panel width, depth of cover and geological structures around the valley. It is found that mining in a series passing beneath the valley dramatically increases valley closure, and mining parallel to valley induces much more closure than other mining orientations. The redistribution of horizontal stress and influence of mining activity have also been recognised as important factors promoting valley closure, and the effect of geological structure around the valley is found to be relatively small. This paper provides further insight into both the valley closure mechanisms and how these mechanisms should be considered in valley closure prediction models.

32 CFR 989.25 - Base closure and realignment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROTECTION ENVIRONMENTAL IMPACT ANALYSIS PROCESS (EIAP) § 989.25 Base closure and realignment. Base closure or realignment may entail special requirements for environmental analysis. The permanent base closure... frequently contain provisions limiting the extent of environmental analysis required for actions taken under...

32 CFR 989.25 - Base closure and realignment.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PROTECTION ENVIRONMENTAL IMPACT ANALYSIS PROCESS (EIAP) § 989.25 Base closure and realignment. Base closure or realignment may entail special requirements for environmental analysis. The permanent base closure... frequently contain provisions limiting the extent of environmental analysis required for actions taken under...

40 CFR 264.118 - Post-closure plan; amendment of plan.

Code of Federal Regulations, 2014 CFR

2014-07-01

... days after an unexpected event has occurred which has affected the post-closure plan. An owner or... 40 Protection of Environment 26 2014-07-01 2014-07-01 false Post-closure plan; amendment of plan... FACILITIES Closure and Post-Closure § 264.118 Post-closure plan; amendment of plan. (a) Written Plan. The...

40 CFR 264.118 - Post-closure plan; amendment of plan.

Code of Federal Regulations, 2011 CFR

2011-07-01

... days after an unexpected event has occurred which has affected the post-closure plan. An owner or... 40 Protection of Environment 26 2011-07-01 2011-07-01 false Post-closure plan; amendment of plan... FACILITIES Closure and Post-Closure § 264.118 Post-closure plan; amendment of plan. (a) Written Plan. The...

40 CFR 264.118 - Post-closure plan; amendment of plan.

Code of Federal Regulations, 2012 CFR

2012-07-01

... days after an unexpected event has occurred which has affected the post-closure plan. An owner or... 40 Protection of Environment 27 2012-07-01 2012-07-01 false Post-closure plan; amendment of plan... FACILITIES Closure and Post-Closure § 264.118 Post-closure plan; amendment of plan. (a) Written Plan. The...

40 CFR 264.118 - Post-closure plan; amendment of plan.

Code of Federal Regulations, 2013 CFR

2013-07-01

... days after an unexpected event has occurred which has affected the post-closure plan. An owner or... 40 Protection of Environment 27 2013-07-01 2013-07-01 false Post-closure plan; amendment of plan... FACILITIES Closure and Post-Closure § 264.118 Post-closure plan; amendment of plan. (a) Written Plan. The...

40 CFR 264.118 - Post-closure plan; amendment of plan.

Code of Federal Regulations, 2010 CFR

2010-07-01

... days after an unexpected event has occurred which has affected the post-closure plan. An owner or... 40 Protection of Environment 25 2010-07-01 2010-07-01 false Post-closure plan; amendment of plan... FACILITIES Closure and Post-Closure § 264.118 Post-closure plan; amendment of plan. (a) Written Plan. The...

Uncertainty Quantification of Multi-Phase Closures

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

Nadiga, Balasubramanya T.; Baglietto, Emilio

In the ensemble-averaged dispersed phase formulation used for CFD of multiphase ows in nuclear reactor thermohydraulics, closures of interphase transfer of mass, momentum, and energy constitute, by far, the biggest source of error and uncertainty. Reliable estimators of this source of error and uncertainty are currently non-existent. Here, we report on how modern Validation and Uncertainty Quanti cation (VUQ) techniques can be leveraged to not only quantify such errors and uncertainties, but also to uncover (unintended) interactions between closures of di erent phenomena. As such this approach serves as a valuable aide in the research and development of multiphase closures.more » The joint modeling of lift, drag, wall lubrication, and turbulent dispersion|forces that lead to tranfer of momentum between the liquid and gas phases|is examined in the frame- work of validation of the adiabatic but turbulent experiments of Liu and Banko , 1993. An extensive calibration study is undertaken with a popular combination of closure relations and the popular k-ϵ turbulence model in a Bayesian framework. When a wide range of super cial liquid and gas velocities and void fractions is considered, it is found that this set of closures can be validated against the experimental data only by allowing large variations in the coe cients associated with the closures. We argue that such an extent of variation is a measure of uncertainty induced by the chosen set of closures. We also nd that while mean uid velocity and void fraction pro les are properly t, uctuating uid velocity may or may not be properly t. This aspect needs to be investigated further. The popular set of closures considered contains ad-hoc components and are undesirable from a predictive modeling point of view. Consequently, we next consider improvements that are being developed by the MIT group under CASL and which remove the ad-hoc elements. We use non-intrusive methodologies for sensitivity analysis and calibration

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.

Comparison of effectiveness and cost of patent ductus arteriosus device occlusion versus surgical ligation of patent ductus arteriosus.

PubMed

Zulqarnain, Arif; Younas, Muhammad; Waqar, Tariq; Beg, Ahsan; Asma, Touseef; Baig, Mirza Ahmad Raza

2016-01-01

Comparison of effectiveness and cost of transcatheter occlusion of patent ductus arteriosus (PDA) with surgical ligation of PDA. This retrospective comparative study was conducted in the pediatric cardiology department of Ch. Pervaiz Elahi Institute of Cardiology Multan, Pakistan. Data of 250 patients who underwent patent ductus arteriosus (PDA) closure either surgical or trans-catheter closure using SHSMA Occluder having weight >5 kg from April 2012 to October 2015 were included in this study. SPSS version 20 was used for data analysis. Quantitative variables were compared using independent sample t-test. Chi-square test and fishers exact was used for qualitative variables. P-value <0.05 was considered statistically significant. There were one hundred and twenty (120) patients who underwent transcatheter occlusion of PDA using SHSMA occluder (PDA Device Group) and one hundred and thirty (130) patients who underwent surgical ligation of PDA (Surgical Group). Incidence of residual shunting was two (1.5%) in surgical group and 0 (0.0%) in PDA Device group for one month follow up period. There were 4 (3.1%) major complications in surgical group. The rate of blood transfusions were high in surgical group (p-value 0.04). Hospital stay time was significantly less in PDA Device group (P-value <0.001). Total procedural cost was 110695+1054 Pakistani rupees in PDA Device group and 92414+3512 in surgical group (p-value <0.001). The cost of PDA device closure was 16.52% higher than the surgical ligation of PDA. There was no operative mortality. The transcatheter closure of PDA is an effective and less invasive method as compared to the surgical ligation. There is a lower rate of complications and the cost is not much high as compared to surgical PDA ligation.

Comparison of effectiveness and cost of patent ductus arteriosus device occlusion versus surgical ligation of patent ductus arteriosus

PubMed Central

Zulqarnain, Arif; Younas, Muhammad; Waqar, Tariq; Beg, Ahsan; Asma, Touseef; Baig, Mirza Ahmad Raza

2016-01-01

Objectives: Comparison of effectiveness and cost of transcatheter occlusion of patent ductus arteriosus (PDA) with surgical ligation of PDA. Methods: This retrospective comparative study was conducted in the pediatric cardiology department of Ch. Pervaiz Elahi Institute of Cardiology Multan, Pakistan. Data of 250 patients who underwent patent ductus arteriosus (PDA) closure either surgical or trans-catheter closure using SHSMA Occluder having weight >5 kg from April 2012 to October 2015 were included in this study. SPSS version 20 was used for data analysis. Quantitative variables were compared using independent sample t-test. Chi-square test and fishers exact was used for qualitative variables. P-value <0.05 was considered statistically significant. Results: There were one hundred and twenty (120) patients who underwent transcatheter occlusion of PDA using SHSMA occluder (PDA Device Group) and one hundred and thirty (130) patients who underwent surgical ligation of PDA (Surgical Group). Incidence of residual shunting was two (1.5%) in surgical group and 0 (0.0%) in PDA Device group for one month follow up period. There were 4 (3.1%) major complications in surgical group. The rate of blood transfusions were high in surgical group (p-value 0.04). Hospital stay time was significantly less in PDA Device group (P-value <0.001). Total procedural cost was 110695+1054 Pakistani rupees in PDA Device group and 92414+3512 in surgical group (p-value <0.001). The cost of PDA device closure was 16.52% higher than the surgical ligation of PDA. There was no operative mortality. Conclusion: The transcatheter closure of PDA is an effective and less invasive method as compared to the surgical ligation. There is a lower rate of complications and the cost is not much high as compared to surgical PDA ligation. PMID:27648051

40 CFR 267.143 - Financial assurance for closure.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 26 2010-07-01 2010-07-01 false Financial assurance for closure. 267... PERMIT Financial Requirements § 267.143 Financial assurance for closure. The owner or operator must establish financial assurance for closure of each storage or treatment unit that he owns or operates. In...

Patent ductus arteriosus associated with aberrant right subclavian artery: two cases, one successful interventional closure of PDA.

PubMed

Gomez, Jorge E; Gentile, Jorge I

2011-01-01

Two children were sent to the catheterization laboratory for transcatheter closure of patent ductus arteriosus (PDA). During the intervention, cineangiogram revealed associated aberrant right subclavian artery (ARSA). Both patients had left-sided aortic arch. The first patient was sent to surgery after one unsuccessful attempt to close the PDA due to the proximity of the ARSA and also because of other concomitant cardiac lesions. We successfully treated the second patient by closing the PDA with a Nit-Occlud® PDA occlusion device (Pfm Medical, Carlsbad, California). Similar mirror cases of PDA closure with aberrant left subclavian artery and right aortic arch have been reported. Anatomic features, as well as the technique and management of the procedure, are discussed here.

Finger-Circumference-Measuring Device

NASA Technical Reports Server (NTRS)

Le, Suy

1995-01-01

Easy-to-use device quickly measures circumference of finger (including thumb) on human hand. Includes polytetrafluoroethylene band 1/8 in. wide, bent into loop and attached to tab that slides on scale graduated in millimeters. Sliding tab preloaded with constant-force tension spring, which pulls tab toward closure of loop. Designed to facilitate measurements at various points along fingers to obtain data for studies of volumetric changes of fingers in microgravity. Also used in normal Earth gravity studies of growth and in assessment of diseases like arthritis.

Phase closure nulling: Theory and practice

NASA Astrophysics Data System (ADS)

Chelli, A.; Duvert, G.; Malbet, F.; Kern, P.

2009-11-01

We provide a complete theory of the phase closure of a binary system in which a small, feeble, and unresolved companion acts as a perturbing parameter on the spatial frequency spectrum of a dominant, bright, resolved source. We demonstrate that the influence of the companion can be measured with precision by measuring the phase closure of the system near the nulls of the primary visibility function. In these regions of phase closure nulling, frequency intervals always exist where the phase closure signature of the companion is larger than any systematic error and can thus be measured. We show that this technique allows retrieval of many astrophysically relevant properties of faint and close companions such as flux, position, and in favorable cases, spectrum. As a proof of concept, using the AMBER/VLTI instrument with 3 auxiliary telescopes of 1.8 m and only 15 minutes of on-sky integration, we detected the five magnitudes fainter companion of HD 59717 at only 3.5 stellar radii distance from the primary. This is one of the highest contrast detected by interferometry between a companion and its parent star. We conclude by a rapid study of the potentialities of phase closure nulling observations with current interferometers and explore the requirements for a new type of dedicated instrument.

The Effect of Rural Hospital Closures on Community Economic Health

PubMed Central

Holmes, George M; Slifkin, Rebecca T; Randolph, Randy K; Poley, Stephanie

2006-01-01

Objective To examine the effect of rural hospital closures on the local economy. Data Sources U.S. Census Bureau, OSCAR, Medicare Cost Reports, and surveys of individuals knowledgeable about local hospital closures. Study Design Economic data at the county level for 1990–2000 were combined with information on hospital closures. The study sample was restricted to rural counties experiencing a closure during the sample period. Longitudinal regression methods were used to estimate the effect of hospital closure on per-capita income, unemployment rate, and other community economic measures. Models included both leading and lagged closure terms allowing a preclosure economic downturn as well as time for the closure to be fully realized by the community. Data Collection Information on closures was collected by contacting every state hospital association, reconciling information gathered with that contained in the American Hospital Association file and OIG reports. Principal Findings Results indicate that the closure of the sole hospital in the community reduces per-capita income by $703 (p<0.05) or 4 percent (p<0.05) and increases the unemployment rate by 1.6 percentage points (p<0.01). Closures in communities with alternative sources of hospital care had no long-term economic impact, although income decreased for 2 years following the closure. Conclusions The local economic effects of a hospital closure should be considered when regulations that affect hospitals' financial well-being are designed or changed. PMID:16584460

Apical closure device for full-percutaneous transapical valve implantation: stress-test in an animal model†.

PubMed

Ferrari, Enrico; Demertzis, Stefanos; Angelella, Jennifer; Berdajs, Denis; Tozzi, Piergiorgio; Moccetti, Tiziano; Maisano, Francesco; von Segesser, Ludwig K

2017-05-01

Transapical valve implantation is traditionally performed through a left antero-lateral mini-thoracotomy. A self-expandable apical closure device has recently been developed for full-percutaneous transapical valve implantation. We performed haemodynamics stress-tests on an animal model to evaluate the sealing properties. Under general anaesthesia 5 pigs (mean weight: 67 ± 6 Kg) received full heparinization (100 IU/Kg; activated clotting time >250 s and, through inferior mini-sternotomies, 21-Fr introducer sheaths for transapical aortic valve implantation (outer diameter: 25-Fr) were placed over-the-wire in the apexes. Delivery-catheters carrying folded occluders (SAFEX TM final design) were inserted in the introducer sheaths and plugs were then deployed under fluoroscopic guidance. Phase 1: after protamine injection, apical bleeding was monitored for 1 h with standard haemodynamics condition. Phase 2: we induced systemic hypertension with adrenaline infusion to test the sealing properties under stress. Animals were sacrificed after Phase 2 and hearts were removed and inspected. Five plugs were successfully introduced and deployed in 5 pig hearts. Plugs provided good apical sealing in each animal and a mean of 7 ± 4 ml of blood lost per animal was collected during Phase 1: haemodynamics remained stable and no plug dislodgement was detected (mean blood pressure: 52 ± 9 mmHg). During Phase 2, mean systolic and diastolic peak levels reached 268 ± 24 mmHg and 175 ± 17 mmHg, respectively, without plug dislodgment or bleeding. Post-mortem inspection showed good plug deployment and fixation without myocardial damage. The new apical occluder seals large-sized apical access sites in animal models also during induced systemic hypertension. This pilot study is a further step towards full-percutaneous transapical valve procedures in the clinical setting. © The Author 2017. Published by Oxford University Press on behalf of the European

50 CFR 635.28 - Fishery closures.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 50 Wildlife and Fisheries 12 2013-10-01 2013-10-01 false Fishery closures. 635.28 Section 635.28 Wildlife and Fisheries FISHERY CONSERVATION AND MANAGEMENT, NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE ATLANTIC HIGHLY MIGRATORY SPECIES Management Measures § 635.28 Fishery closures. (a...

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.

Closure versus non-closure of the peritoneum at caesarean section: short- and long-term outcomes

PubMed Central

Bamigboye, Anthony A; Hofmeyr, G Justus

2014-01-01

Background Caesarean section is a very common surgical procedure worldwide. Suturing the peritoneal layers at caesarean section may or may not confer benefit, hence the need to evaluate whether this step should be omitted or routinely performed. Objectives The objective of this review was to assess the effects of non-closure as an alternative to closure of the peritoneum at caesarean section on intraoperative and immediate- and long-term postoperative outcomes. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (1 November 2013). Selection criteria Randomised controlled trials comparing leaving the visceral or parietal peritoneum, or both, unsutured at caesarean section with a technique which involves suturing the peritoneum in women undergoing elective or emergency caesarean section. Data collection and analysis Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked it for accuracy. Main results A total of 29 trials were included in this review and 21 trials (17,276 women) provided data that could be included in an analysis. The quality of the trials was variable. 1. Non-closure of visceral and parietal peritoneum versus closure of both parietal layers Sixteen trials involving 15,480 women, were included and analysed, when both parietal peritoneum was left unclosed versus when both peritoneal surfaces were closed. Postoperative adhesion formation was assessed in only four trials with 282 women, and no difference was found between groups (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.76 to 1.29). There was significant reduction in the operative time (mean difference (MD) -5.81 minutes, 95% CI -7.68 to -3.93). The duration of hospital stay in a total of 13 trials involving 14,906 women, was also reduced (MD -0.26, 95% CI -0.47 to -0.05) days. In a trial involving 112 women, reduced chronic pelvic pain was found in the peritoneal non-closure group. 2. Non-closure of

Single-site neural tube closure in human embryos revisited.

PubMed

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

2017-10-01

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

Left atrial appendage resection can be performed minimally invasively with good clinical and echocardiographic outcomes without any severe risk.

PubMed

Inoue, Takafumi; Suematsu, Yoshihiro

2018-01-22

The adverse effects of left atrial appendage (LAA) closure have not yet been evaluated. This study aimed to prove the safety and low invasiveness of LAA resection through our thoracoscopic stand-alone left atrial appendectomy experience. Eighty-seven patients [mean age 68 ± 9 years, 68 men (78%), mean congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack to thromboembolism, vascular disease, age 65-74 years and sex category (CHA2DS2-VASc) score 2.9 ± 1.6 points] who had undergone thoracoscopic left atrial appendectomy were selected. The operative and clinical data (left atrial diameter, left ventricular diameter of systole/diastole, ejection fraction, brain natriuretic peptide and human atrial natriuretic peptide) were evaluated. All procedures were performed without cardiopulmonary bypass or cardiac arrest. The LAA was resected with an endoscopic linear cutter device. Except for 1 case with severe pleural adhesion, all operations were performed thoracoscopically. The preoperative and postoperative data are as follows: left atrial diameter 43 ± 5 mm and 43 ± 5 mm (P = 0.8); left ventricular diameter of systole/diastole 50 ± 5/35 ± 6 mm and 48 ± 5/34 ± 6 mm (P < 0.01); ejection fraction 57 ± 10% and 56 ± 10% (P = 0.11); brain natriuretic peptide 97 ± 77 pg/ml and 72 ± 65 pg/ml (P < 0.01) and human atrial natriuretic peptide 73 ± 64 pg/ml and 96 ± 67 pg/ml (P = 0.03), respectively. The mean volume of bleeding in the operation was very small (<10 ml). The mean length of postoperative in-hospital stay was 3.8 ± 1.8 days. All the patients were discharged while maintaining their preoperative activities of daily living without major complications. No thrombus or residual stumps were detected during the 3-month postoperative computed tomography follow-up. The perioperative heart

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.