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Closure Device (closure + device)
Selected AbstractsUse of the Vacuum-Assisted Closure Device in Enhancing Closure of a Massive Skull Defect,THE LARYNGOSCOPE, Issue 6 2004Umesh S. Marathe MD Abstract Objectives/Hypothesis: The objective was to describe a novel technique for reconstructing the cranial vertex without the use of free tissue transfer. Study Design: Case report, literature review, and discussion. Methods: A 50-year-old woman presented from a remote Pacific Island community with a 12 × 14-cm, necrotic, grossly contaminated eccrine gland carcinoma of the cranial vertex that extended through the calvarium but did not invade the dura. Following tumor extirpation, the resulting bony defect was 10 × 12 cm in size, with a concomitant scalp defect of 14 × 16 cm. Free tissue transfer was impossible because of severe intimal peripheral vascular disease, posing a challenging reconstructive dilemma. After tumor resection, the bony edges were covered with local scalp flaps and the vacuum-assisted closure device was placed over the wound at a constant setting of ,50 mm Hg. The vacuum-assisted closure device was changed three times per week for 3 weeks. Results: A thick, 1-cm bed of granulation tissue developed over the dura, allowing temporary coverage by a split-thickness skin graft, and the scalp defect decreased in size by approximately 25%. The patient did not develop meningitis, headache, or localized infection as a result of placement of the vacuum-assisted closure device and tolerated the vacuum-assisted closure well. After a requisite period of healing, tissue expanders and calvarial reconstruction will be performed. Conclusion: Use of the vacuum-assisted closure device is a safe, reliable adjunct in the closure of large cranial defects with exposed dura and offers a novel reconstructive option for complex defects of the head and neck. [source] Port-a-Cath perforation of the right atrium closed with an amplatzer ASD occluderCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 1 2007Sunil Wani MD Abstract Right atrial perforation can lead to tamponade and death. Closure devices are used for sealing of shunts in the heart. We describe an indwelling catheter that caused perforation of the right atrium and was treated with a percutaneous closure device. © 2007 Wiley-Liss, Inc. [source] Patent Foramen Ovale Using the Premere Device: The Results of the CLOSEUP TrialJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 4 2006FRANZISKA BÜSCHECK M.D. Objectives: The CLOSEUP trial was conducted to determine the safety and effectiveness of the Premere closure device in closure of patent foramen ovale (PFO). Background: PFO is a relatively common congenital condition, associated with cryptogenic stroke and migraine with aura. The Premere device is specifically designed to close PFO of variable size and length, with right and left anchor arms connected by a flexible tether. The device has an open architecture, a low profile, and a small surface area on the left atrial side which may discourage thrombus formation. Methods: Patients between 18 and 65 years of age who had a cryptogenic ischemic stroke or a transient ischemic attack and a PFO underwent percutaneous PFO closure using the Premere device. Results: Of the 73 enrolled patients, six patients had atrial anatomy not appropriate for the Premere; 27 patients received the 15 mm and 40 patients received the 20 mm device. Implantation was successful in all patients. At 6 months of follow-up, 86% of patients had no shunt that could be provoked with Valsalva as assessed during contrast echocardiography. Closure rates were better with the 20 mm versus the 15 mm device, and three patients with residual shunt had atrial septal aneurysms at baseline. One patient had transient atrial fibrillation which resolved by 3 months. There were no instances of thrombus, death, or stroke. Conclusions: These data demonstrate that the Premere device can safely and effectively close PFO. Additional studies should be undertaken to demonstrate the effectiveness of PFO closure in reducing thrombo-embolic events such as stroke. [source] Percutaneous Suture Closure for Management of Large French Size Arterial and Venous PunctureJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 4 2000TED FELDMAN M.D. Aortic valvuloplasty procedures have been limited principally by the occurrence of restenosis in this patient population. Once a decision has been made to proceed with aortic valvuloplasty, one of the next major concerns is management of the femoral artery puncture. For these procedures, 12Fr and 14Fr sheath introducers and prolonged compression with clamps or hemostatic devices have been necessary. Prolonged immobilization is painful for the elderly population in whom aortic valvuloplasty is used. The ability to use percutaneous suture closure to eliminate the need for manual compression, especially for clamp or hemostatic devices, has greatly improved patient tolerance for these procedures. A technique for preloading the suture closure device prior to insertion of a large bore sheath is the technique of choice to make this possible. Mitral valvuloplasty has faced fewer limitations and of course yields results equivalent to surgical commissurotomy in randomized trials. Improved management of the 14Fr femoral venous site has made outpatient treatment simpler. The technical approach necessary for success in the venous system uses contrast injections through the Perclose device marker port to insure that the device is properly positioned prior to deployment of the sutures. More rapid immobilization and simplified postprocedural management can be achieved using percutaneous suture closure for large caliber sheaths after mitral and aortic valvuloplasty. [source] Extensive allergic reaction to a new wound closure device (PrineoÔ)ALLERGY, Issue 6 2010K. M. Dunst No abstract is available for this article. [source] Use of the Vacuum-Assisted Closure Device in Enhancing Closure of a Massive Skull Defect,THE LARYNGOSCOPE, Issue 6 2004Umesh S. Marathe MD Abstract Objectives/Hypothesis: The objective was to describe a novel technique for reconstructing the cranial vertex without the use of free tissue transfer. Study Design: Case report, literature review, and discussion. Methods: A 50-year-old woman presented from a remote Pacific Island community with a 12 × 14-cm, necrotic, grossly contaminated eccrine gland carcinoma of the cranial vertex that extended through the calvarium but did not invade the dura. Following tumor extirpation, the resulting bony defect was 10 × 12 cm in size, with a concomitant scalp defect of 14 × 16 cm. Free tissue transfer was impossible because of severe intimal peripheral vascular disease, posing a challenging reconstructive dilemma. After tumor resection, the bony edges were covered with local scalp flaps and the vacuum-assisted closure device was placed over the wound at a constant setting of ,50 mm Hg. The vacuum-assisted closure device was changed three times per week for 3 weeks. Results: A thick, 1-cm bed of granulation tissue developed over the dura, allowing temporary coverage by a split-thickness skin graft, and the scalp defect decreased in size by approximately 25%. The patient did not develop meningitis, headache, or localized infection as a result of placement of the vacuum-assisted closure device and tolerated the vacuum-assisted closure well. After a requisite period of healing, tissue expanders and calvarial reconstruction will be performed. Conclusion: Use of the vacuum-assisted closure device is a safe, reliable adjunct in the closure of large cranial defects with exposed dura and offers a novel reconstructive option for complex defects of the head and neck. [source] Trapping of vascular clip closure device in previously accessed femoral puncture siteCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 1 2007Steven J. Fowler MD No abstract is available for this article. [source] Delivery sheath tear after modification for ASD closureCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 1 2006FSCAI, Mark H. Hoyer MD Abstract During transcatheter closure of an atrial septal defect with insufficient aortic rim, a standard delivery sheath was modified by cutting a bevel at the distal tip to improve device orientation. The sheath split longitudinally when attempting to recapture the closure device. Troubleshooting allowed a device to be implanted successfully. Pitfalls regarding our sheath modification and methods to overcome prolapse of the left atrial disk into the right atrium are discussed. © 2006 Wiley-Liss, Inc. [source] Comparison of costs and safety of a suture-mediated closure device with conventional manual compression after coronary artery interventionsCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2002Hans Rickli MD Abstract The aim of this study was to assess costs and safety of immediate femoral sheath removal and closure with a suture-mediated closure device (Perclose, Menlo Park, CA) in patients undergoing elective (PCI). A total of 193 patients was prospectively randomized to immediate arterial sheath removal and access site closure with a suture-mediated closure device (SMC; n = 96) or sheath removal 4 hr after PCI followed by manual compression (MC; n = 97). In the SMC group, patients were ambulated 4 hr after elective PCI if hemostasis was achieved. In the MC group, patients were ambulated the day after the procedure. In addition to safety, total direct costs including physician and nursing time, infrastructure, and the device were assessed in both groups. Total direct costs were significantly (all P < 0.001) lower in the SMC group. Successful hemostasis without major complication was achieved in all patients. The time to achieve hemostasis was significantly shorter in the SMC group (7.1 ± 3.4 vs. 22.9 ± 14.0 min; P < 0.01) and 85% of SMC patients were ambulated on the day of intervention. Suture-mediated closure allows a reduction in hospitalization time, leading to significant cost savings due to decreased personnel and infrastructural demands. In addition, the use of SMC is safe and convenient to the patients. Cathet Cardiovasc Intervent 2002;57:297,302. © 2002 Wiley-Liss, Inc. [source] Randomized comparison of vasoseal and angioseal closure devices in patients undergoing coronary angiography and angioplastyCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2002Nicolas W. Shammas MD Abstract AngioSeal (AS) and VasoSeal (VS) are collagen-based arterial closure devices utilized to achieve earlier hemostasis and ambulation in diagnostic and interventional percutaneous procedures. To our knowledge, there has been no randomized studies comparing these two devices as approved for use in the United States. One hundred fifty-seven patients were randomized to receive either the 8 Fr AS (n = 79) or VS (n = 78) closure device. Data on 95 patients who had coronary angiography (49 AS, 46 VS) and 55 patients who underwent angioplasty (28 AS, 27 VS) were completed. Heparin was not administered during the coronary angiogram procedure. The activated clotting time was kept at approximately 300 sec during angioplasty. Patients on coumadin or GP IIb/IIIa platelet inhibitors were not included in this study. The time unit interval to achieve hemostasis in this study was based on the time the AS tension spring was left over the common femoral artery following collagen deployment as per the manufacturer's instructions (20 min). Time to hemostasis, time to ambulation, and major and minor complications were prospectively recorded. Two-tailed t -test and chi-square analysis were performed on continuous and dichotomous variables, respectively. For the angiogram-only subgroup, time (min) to hemostasis (20.51 ± 4.36 vs. 18.59 ± 11.77; P = 0.30) and ambulation (145.71 ± 124 vs. 109.89 ± 60.37; P = 0.075) were not statistically different for the AS and VS, respectively. Similarly, for the angioplasty subgroup, time (min) to hemostasis (24.23 ± 12.70 vs. 19.57 ± 2.27; P = 0.077) and ambulation (607.32 ± 344.22 vs. 486.48 ± 200.37; P = 0.12) were not statistically different for both AS and VS, respectively. Furthermore, there were no statistical differences in deployment failure, major, minor, or total complication rates between the two devices. In the absence of GP IIb/IIIa inhibitors, VS and the 8 Fr AS devices have statistically similar time to hemostasis and ambulation as well as device failures and complication rates following coronary angiography and angioplasty. Cathet Cardiovasc Intervent 2002;55:421,425. © 2002 Wiley-Liss, Inc. [source] Transcatheter closure of patent foramen ovale during a radiofrequency ablation procedureCLINICAL CARDIOLOGY, Issue 8 2006Antonis S. Manolis M.D. Abstract A 43-year-old woman was undergoing radiofrequency catheter ablation of a symptomatic supraventricular tachycardia when a patent foramen ovale (PFO) was detected with passage of the diagnostic electrocatheter into the left atrium. Prior echocardiographic studies had been unrevealing. Upon questioning during the procedure, the patient now admitted to frequent and disabling daily migraine attacks, while her family described two recent brief episodes of disorientation and dysarthria, consistent with transient ischemic attacks. The patient was informed of the option of future closure of the PFO, but she insisted on having this done concurrently with her ablation procedure. After successful ablation of the slow pathway considered responsible for the supraventricular tachycardia, an Amplatzer closure device was utilized and the PFO was successfully closed during the same procedure. A postprocedural transesophageal echocardiogram showed complete sealing of the PFO, while over the ensuing 10 months the patient reported virtual elimination of her daily attacks of migrainous headaches, limited to a single episode the day after the procedure and none thereafter. [source] Patent foramen ovale and cryptogenic cerebral infarctionINTERNAL MEDICINE JOURNAL, Issue 1 2001D. McGaw Abstract The patent foramen ovale (PFO) has been increasingly implicated in the aetiology of stroke, particularly in young patients with no other identifiable cause (cryptogenic stroke). The mechanism is by the passage of venous clots through the patent foramen into the arterial circulation, enabling cerebral embolism. Such patients with cryptogenic stroke and PFO are often treated with life-long anticoagulants or antiplatelet agents in an attempt to decrease the risk of a recurrence. Less commonly, surgical closure of the PFO has been undertaken in these patients. However, the recent evolution of closure devices that are delivered percutaneously by standard cardiac catheter techniques now offer an alternative non-surgical option. These alternative therapies are yet to be compared adequately. Two issues remain to be resolved. First, in determining appropriate therapy, patients with cryptogenic stroke may be divided into three groups: those with no PFO but an alternative unrecognized aetiology, those with an ,innocent' PFO and an alternative unrecognized aetiology and those with a causative PFO. The distinction between these groups clearly has important treatment implications. Second, the risk versus benefit of each available treatment modality must be determined for these different patient subgroups. These two issues require resolution before rational evidence-based treatment can be prescribed for patients with PFO and cryptogenic stroke. (Intern Med J 2001; 31: 42,47) [source] Balloon sizing and transcatheter closure of acute atrial septal defects guided by magnetic resonance fluoroscopy: Assessment and validation in a large animal model,JOURNAL OF MAGNETIC RESONANCE IMAGING, Issue 3 2005Simon Schalla MD Abstract Purpose To quantitatively assess atrial septal defects (ASDs) with small shunts using MRI followed by transcatheter closure monitored by MR fluoroscopy. Materials and Methods Acute ASDs were created in 14 pigs under x-ray fluoroscopy. Six animals were studied in order to select MR-compatible delivery systems and imaging strategies. ASDs in eight animals were examined with balloon sizing under MR fluoroscopy, flow measurements, and contrast media injections, after which transcatheter closure was performed under MR fluoroscopy. The delivery system was assembled from commercially available materials. Results The ratio of pulmonary to systemic flow (Qp/Qs) was reduced from 1.23 ± 0.15 before ASD closure to 1.07 ± 0.11 after ASD closure (P < 0.001). In two out of eight animals Qp/Qs was close to 1.0 before closure despite the presence of defects >15 mm. The ASDs were measurable with MR balloon sizing in all of the animals. Balloon sizing was identical with MR (16.9 ± 2.3 mm) and x-ray fluoroscopy (17.1 ± 1.3 mm). The in-house-assembled delivery system allowed successful placement of closure devices under MR guidance. Conclusion Assessment and closure of small shunts with MR fluoroscopy is feasible. A barrier to the rapid implementation of transcatheter closure in patients is uncertainty about the MR safety of guidewires and device delivery systems. J. Magn. Reson. Imaging 2005;21:204,211. © 2005 Wiley-Liss, Inc. [source] Re-access complication with a starclose device,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2009Rekhi Varghese MD Abstract Diagnostic cardiac catheterizations are predominantly performed using access through the femoral artery. To improve patient comfort and early mobilization, a number of percutaneous closure devices have been developed. One such device using the nitinol clip was developed by Abbott Vascular Devices and was approved for use on the basis of the results of the Clip Closure In Percutaneous Procedures (CLIP) study. The safety of repuncture through a previously deployed device has not been established in humans. We present the case of a patient who had an arterial line placed for post-operative monitoring after cardiac surgery at the site of a previous arteriotomy closed with the Starclose device. The catheter traversed through the central portion, tethered to the periphery of the ninitol clip, and required surgery for extraction. © 2009 Wiley-Liss, Inc. [source] Randomized comparison of vasoseal and angioseal closure devices in patients undergoing coronary angiography and angioplastyCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2002Nicolas W. Shammas MD Abstract AngioSeal (AS) and VasoSeal (VS) are collagen-based arterial closure devices utilized to achieve earlier hemostasis and ambulation in diagnostic and interventional percutaneous procedures. To our knowledge, there has been no randomized studies comparing these two devices as approved for use in the United States. One hundred fifty-seven patients were randomized to receive either the 8 Fr AS (n = 79) or VS (n = 78) closure device. Data on 95 patients who had coronary angiography (49 AS, 46 VS) and 55 patients who underwent angioplasty (28 AS, 27 VS) were completed. Heparin was not administered during the coronary angiogram procedure. The activated clotting time was kept at approximately 300 sec during angioplasty. Patients on coumadin or GP IIb/IIIa platelet inhibitors were not included in this study. The time unit interval to achieve hemostasis in this study was based on the time the AS tension spring was left over the common femoral artery following collagen deployment as per the manufacturer's instructions (20 min). Time to hemostasis, time to ambulation, and major and minor complications were prospectively recorded. Two-tailed t -test and chi-square analysis were performed on continuous and dichotomous variables, respectively. For the angiogram-only subgroup, time (min) to hemostasis (20.51 ± 4.36 vs. 18.59 ± 11.77; P = 0.30) and ambulation (145.71 ± 124 vs. 109.89 ± 60.37; P = 0.075) were not statistically different for the AS and VS, respectively. Similarly, for the angioplasty subgroup, time (min) to hemostasis (24.23 ± 12.70 vs. 19.57 ± 2.27; P = 0.077) and ambulation (607.32 ± 344.22 vs. 486.48 ± 200.37; P = 0.12) were not statistically different for both AS and VS, respectively. Furthermore, there were no statistical differences in deployment failure, major, minor, or total complication rates between the two devices. In the absence of GP IIb/IIIa inhibitors, VS and the 8 Fr AS devices have statistically similar time to hemostasis and ambulation as well as device failures and complication rates following coronary angiography and angioplasty. Cathet Cardiovasc Intervent 2002;55:421,425. © 2002 Wiley-Liss, Inc. [source] Registry for atrial septal defect/patent foramen ovale closure devices for platypnea-orthodeoxia syndromeCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 4 2002Tsung O. Cheng MD No abstract is available for this article. [source] Patterns of Use of Topical Skin Adhesives in the Emergency DepartmentACADEMIC EMERGENCY MEDICINE, Issue 6 2010Adam J. Singer MD Abstract Objectives:, The objective was to determine patterns of use of topical skin adhesives (TSA) for laceration repair. The authors hypothesized that TSA use would be more common in children and facial lacerations. Methods:, This was a structured retrospective chart review. The setting was a suburban, university-based emergency department (ED) with an emergency medicine (EM) residency; the annual census is 85,000 visits. Charts from consecutive patients presenting with lacerations in the summer of 2008 (June 2008 through August 2008) were reviewed. Demographic, clinical, and wound characteristics were extracted from electronic medical records by trained investigators using structured data collection forms. Characteristics of lacerations repaired with TSA or other closure devices were compared with bivariate and multivariate analyses using odds ratios (ORs) and 95% confidence intervals (CIs). Results:, A total of 755 patients presented to the ED with lacerations over the study period, of whom primary closure was used in 667; nine were excluded because the method of closure was unknown. The most common methods of laceration closure were sutures (485), adhesives (88), and staples (86). Adhesives were used to close 27% of facial lacerations, compared to 4% of all other body locations (difference = 23%, 95% CI = 18% to 29%), and in 20% of pediatric versus 8% of adult lacerations (difference = 13%, 95% CI = 7% to 18%). Adjustment for other potential patient and wound characteristics showed that adhesives were more likely to be used to close facial lacerations (OR = 10.0 CI, 95% CI = 5.5 to 18.0) and lacerations in children (OR = 1.8, 95% CI = 1.1 to 3.0) and less likely to be used as laceration length increased (OR = 0.6, 95% CI = 0.4 to 0.8). Adhesive use was not statistically associated with patient sex or race, laceration edges or shape, or the need for deep sutures. Forty-three percent of adhesive wounds were closed with no anesthetic, and a topical agent was used in another 48%. In contrast, a local anesthetic agent was injected in 87% of sutured wounds (p < 0.001) and 73% of stapled wounds (p < 0.001). Conclusions:, Topical skin adhesives are used more often for children, facial lacerations, and short lacerations. Use of adhesives may improve patient comfort as need for injecting a local anesthetic is reduced. ACADEMIC EMERGENCY MEDICINE 2010; 17:670,672 © 2010 by the Society for Academic Emergency Medicine [source] | ||||||||||