Transcatheter closure of patent foramen ovale using the Amplatzer septal occluder to prevent recurrence of neurological decompression illness in divers.
OBJECTIVE: Large flap valve patent foramens may cause paradoxical thromboembolism and neurological decompression illness in divers. The ability of a self expanding Nitinol wire mesh device (Amplatzer septal occluder) to produce complete closure of the patent foramen ovale was assessed. PATIENTS: Seven adults, aged 18-60 years, who had experienced neurological decompression illness related to diving. Six appeared to have a normal atrial septum on transthoracic echocardiography, while one was found to have an aneurysm of the interatrial septum. METHODS: Right atrial angiography was performed to delineate the morphology of the right to left shunt. The defects were sized bidirectionally with a precalibrated balloon filled with dilute contrast. The largest balloon diameter that could be repeatedly passed across the septum was used to select the occlusion device diameter. Devices were introduced through 7 F long sheaths. All patients underwent transthoracic contrast echocardiography one month after the implant. RESULTS: Device placement was successful in all patients. Device sizes ranged from 9-14 mm. The patient with an aneurysm of the interatrial septum had three defects, which were closed with two devices. Right atrial angiography showed complete immediate closure in all patients. Median (range) fluoroscopy time was 13.7 (6-35) minutes. Follow up contrast echocardiography showed no right to left shunting in six of seven patients and the passage of a few bubbles in one patient. All patients have been allowed to return to diving. CONCLUSION: The Amplatzer septal occluder can close the large flap valve patent foramen ovale in divers who have experienced neurological decompression illness. Interatrial septal aneurysms with multiple defects may require more than one device. (+info)
Transcatheter occlusion of a post-Fontan residual hepatic vein to pulmonary venous atrium communication using the Amplatzer septal occluder.
A residual hepatic vein to left atrial communication may result in progressive cyanosis after the Fontan procedure. This problem has usually been treated surgically by ligation or re-inclusion of the residual hepatic vein in the Fontan circulation. Previous attempts at transcatheter closure of such veins have been unsuccessful. An Amplatzer septal occluder was successfully used for transcatheter closure of a post-Fontan hepatic vein to pulmonary venous atrium fistula in an 8 year old boy. (+info)
Follow-up results of transvenous occlusion of patent ductus arteriosus with the buttoned device.
OBJECTIVES: The purpose of this presentation is to document results of buttoned device (BD) occlusion of patent ductus arteriosus (PDA) in a large number of patients with particular emphasis on long-term follow-up in an attempt to provide evidence for feasibility, safety and effectiveness of this method of PDA closure. BACKGROUND: Immediate and short-term results of BD occlusion of PDA have been documented in a limited number of children. METHODS: During a six-year period ending August 1996, transcatheter BD closure of PDA was attempted in 284 patients, ages 0.3 to 92 years (median 7) under a protocol approved by the local institutional review boards and FDA with an investigational device exemption in U.S. cases. RESULTS: The PDAs measured 1 to 15 mm (median 4) at the narrowest diameter; 20 were larger than 8 mm and 10 larger than 10 mm. They were occluded with devices measuring from 15 to 35 mm delivered via 7F (N = 140) or 8F (N = 144) sheaths. Successful implantation of the device was accomplished in 278 (98%) of 284 patients. The Qp:Qs decreased from 1.8+/-0.6 (mean+/-SD) to 1.09+/-0.19 (p < 0.001). Effective occlusion defined as no (N = 167 [60%]) or trivial (N = 79 [28%]) residual shunt was achieved in 246 (88%) patients. All types of PDAs, irrespective of the shape (conical, tubular or short), size (small or large) or length (short or long) of the PDA and previously implanted Rashkind devices, could be occluded. Follow-up data, 1 to 60 months (median 24) after device implantation, were available in 234 (84%) patients. Seven (3%) patients required reintervention to treat residual shunt with (N = 2) or without (N = 5) hemolysis. Actuarial reintervention-free rates were 95% at 1 and 5 years. There was gradual reduction of actuarial residual shunts and were 40%, 28%, 21%, 14%, 11%, 10%, 6% and 0% respectively at 1 day, 1, 6, 12, 24, 36, 48 and 60 months after device implantation. Incorporation of folding plug over the button loop in 10 additional patients produced immediate and complete occlusion of PDA. CONCLUSIONS: This large multiinstitutional experience confirms the feasibility, safety and effectiveness of buttoned device closure of PDAs. All types of PDAs irrespective of the shape, length and diameter can be effectively occluded. Incorporation of folding plug over the button loop produces complete PDA occlusion at the time of device implantation. (+info)
Transcatheter closure of a mid-muscular ventricular septal defect with an amplatzer VSD occluder device.
A 5 year old girl with a haemodynamically significant mid-muscular ventricular septal defect (VSD) had successful transcatheter closure using the Amplatzer VSD occluder. This device passes through a small diameter sheath and can be easily retrieved or repositioned. These properties may make it a suitable device for closure of large mid-muscular defects in small children. (+info)
Characteristics of an extended internal fixation system for polysegmental transpedicular reduction and stabilization of the thoracic, lumbar, and lumbosacral spine.
The Kluger internal fixator, with its artificial fulcrum outside the operative site, had to be extended for multisegmental use. Three different prototypes, called Central Bar (CB), Double Bar I (DB I) and Double Bar II (DB II) were designed, which were fully compatible with the existing reduction system. To evaluate the ability of these newly developed systems to provide primary stability in a destabilized spine, their stiffness characteristics and stabilizing effects were investigated in multidirectional biomechanical stability tests and compared with those of the clinically well-known Cotrel-Dubousset (CD) system. The investigations were performed on a spine tester using freshly prepared calf spines. The model tested was that of an intact straight spine followed by a defined three-column lesion simulating the most destabilizing type of injury. Pure moments of up to 7.5 Nm were continuously applied to the top of each specimen in flexion/extension, left/right axial rotation, and left/right lateral bending. Segmental motion was measured using a three-dimensional goniometric linkage system. Range of motion and stiffness within the neutral zone were calculated from obtained load-displacement curves. The DB II attained 112.5% (P = 0.26) of the absolute stiffness of the CD system in flexion and enhanced its stability in extension by up to 144.3% (P = 0.004). In axial rotation of the completely destabilized spine, this system achieved 183.3% of the stiffness of the CD system (P < 0.001), and in lateral bending no motion was measured in the most injured specimens stabilized by the DB II. The DB I, which was the first to be designed and was considered to provide high biomechanical stability, did not attain the stiffness standard set by the CD system in either flexion/extension or axial rotation of the most injured spine. The study confirms that it is worthwhile to evaluate in vitro the biomechanical properties of a newly developed implant before its use in patients, in order to refine weak construction points and help to reduce device-related complications and to better evaluate its efficacy in stabilizing the spine. (+info)
A man with a prosthetic ear and multiple pulmonary nodules.
Basal cell carcinoma is generally regarded as a relatively indolent tumor easily controlled with local therapy. When neglected or inadequately treated this tumor can become locally aggressive and in rare circumstances metastasize. This report documents a case of basal cell carcinoma metastatic to the lung that resulted in rapidly progressive respiratory failure and death. (+info)
Deep sclerectomy with collagen implant: medium term results.
AIMS: To study prospectively the success rate and complications of deep sclerectomy with collagen implant (DSCI), a new non-penetrating filtration procedure. METHODS: Non-randomised prospective trial involving consecutive patients. 100 eyes of 100 patients with medically uncontrolled primary and secondary open angle glaucoma. A superficial scleral flap was raised and a deep sclerectomy was performed in the scleral bed. Schlemm's canal was opened and dissection of the cornea was performed up to Descemet's membrane, at which point aqueous percolated through the remaining trabeculo-Descemet's membrane. A collagen implant was sutured radially in the scleral bed. Visual acuity, intraocular pressure (IOP) measurements, and slit lamp examinations were performed before surgery and after surgery at 1 and 7 days, and 1, 3, 6, 9, 12, 18, 24, 30, and 36 months. RESULTS: The mean follow up period was 17.8 (SD 8.7) months. The mean preoperative IOP was 27.8 (8.6) mm Hg; the mean postoperative IOP was 5.7 (4.0) at day 1, 11.2 (4.6) at month 1, 14.0 (3.5) at month 12, and 13.0 (3.8) at month 36. Complete success rate, defined as an IOP lower than 21 mm Hg without medication, was 44.6% at 36 months. Qualified success rate, defined as an IOP lower than 21 mm Hg with medication, was 97.7% at 36 months. Early postoperative complications included hyphaema in seven patients, would leak in 10 patients, and subtle choroidal detachment in 11 patients. Goniopuncture was performed in 41 of the patients, and 5-fluorouracil injections were made in 23 patients; cataract progression occurred in seven patients. When comparing the different types of open angle glaucoma, no difference was found in terms of reduction in IOP, number of patients requiring antiglaucoma medications, or success rate. CONCLUSIONS: Deep sclerectomy with collagen implant appears to provide reasonable control of IOP at medium term follow up, with few immediate postoperative complications. (+info)
Permanent implantation of expanded polytetrafluoroethylene is safe for pelvic surgery. United States Expanded Polytetrafluoroethylene Reproductive Surgery Study Group.
Clinical trials have shown the expanded polytetrafluoroethylene (ePTFE) membrane to be a highly effective adhesion barrier in gynaecological reconstructive surgery, but the material has not gained wide acceptance because of uncertainty about long-term safety. We conducted a prospective, observational multicentre study to determine if permanent implantation of the ePTFE membrane in the pelvis caused any adverse effects. The subjects were 146 women in whom the membrane was implanted permanently during peritoneal reconstruction in 1991-1996. Postoperatively, patients were examined at regular intervals. The mean postoperative observation time was 3.5 years. No long-term complications occurred. There were 10 births by Caesarean section and 12 by vaginal delivery. All of the pregnancies before these 22 births were uneventful, including 10 in which the women had uterine implantation sites. There were two ectopic pregnancies and three spontaneous abortions. Since the primary purpose of the study was to evaluate the long-term safety of ePTFE, early second-look laparoscopy was not performed routinely. Nevertheless, 24 women had a subsequent operation. Adhesions were present at 8/21 of the membrane sites in these women, a significant decrease compared with adhesions at 17/21 sites during the initial procedure (P = 0.005). This large, multicentre study confirmed the long-term safety of the ePTFE membrane in pelvic reconstruction. Removal of the barrier is not necessary. (+info)