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Biomedical subjects

C Gianturco

Publications and source records attributed to C Gianturco.

At least 19 recordsLinked to original sources

New Gianturco-Grifka vascular occlusion device. Initial studies in a canine model.

BACKGROUND: Transcatheter closure of cardiovascular defects remains a challenge. Several occlusion devices are available, but each device has limitations. The purpose of this study was to evaluate the new Gianturco-Grifka vascular occlusion device (GGVOD) in a canine model. METHODS AND RESULTS: A total of 26 GGVODs were implanted as part of short- and long-term studies. In the short-term study, 1 GGVOD was implanted in each of 11 systemic arteries from 3.2 to 9.0 mm in diameter. All 11 arteries were occluded immediately. In the long-term study, an aortopulmonary shunt was placed in 10 dogs (9, Gore-tex graft; 1, subclavian artery) followed by GGVOD implantation; additionally, a GGVOD was implanted in 5 subclavian arteries. The dogs were boarded for 3 to 6 months, then recatheterized and euthanatized. Immediately after implantation, the 5 subclavian arteries and 9 Gore-tex shunts were occluded completely; the 1 subclavian artery shunt had a small residual leak. At recatheterization, all 10 shunts and 5 subclavian arteries were occluded completely. Necropsy revealed all shunts to be occluded, with the aortic and pulmonic orifices covered with a neointimal layer. The mean fluoroscopic time needed for GGVOD implantation was 9 minutes (range, 3 to 22 minutes). CONCLUSIONS: (1) In a canine model, the GGVOD is effective for transcatheter occlusion of arteries and aortopulmonary shunts from 3 to 9 mm in diameter. Possible indications in children include aortopulmonary collateral vessels, long patent ductus arteriosus, systemic-pulmonary shunts, AV malformations, and arteries supplying tumors. (2) GGVOD implantation requires a short fluoroscopic time.

Animals↗

Abdominal wall hernia repair: use of the Gianturco-Helfrich-Eberbach hernia mesh.

A new polyester hernia mesh (Gianturco-Helfrich-Eberbach) is introduced for laparoscopic repair of the abdominal wall and groin hernias. The device incorporates the optional use of an internal wire to form a circular shape. A detachable carrier is used, permitting easy, accurate preperitoneal placement. Thirty-four patients with groin hernias and five with ventral hernias were repaired without significant complication. This innovative device greatly facilitates mesh placement during transabdominal or extraperitoneal laparoscopic repair, reducing technical difficulty and operative time. It further broadens the use of laparoscopy to repair ventral hernias.

Adult↗

Use of the Gianturco self-expanding stent in stenoses of the superior and inferior venae cavae.

Twenty-eight patients with severe superior and inferior vena cava syndromes were treated with self-expandable Gianturco stents. Nineteen patients responded, seven did not respond, and two were unevaluable. Fourteen of the 19 who responded had complete or near complete resolution of their syndrome, and five had a partial remission. Five of the responders did not derive any benefit from stent placement because of additional problems that led to their death within 3 weeks of the stent placement procedure. The main cause for failure was the relatively weak expansile force of the stent. Complications included stent migrations without untoward effects in one patient, stent misplacement in one patient, fracture of the stent wire in two patients, and hemorrhage that could be attributed to the stent in one patient. This uncontrolled study suggests that caval obstruction syndromes in some patients may be effectively palliated with Gianturco stents.

Adult↗

Prostatic urethra dilatation with the Gianturco self-expanding metallic stent: a feasibility study in cadaver specimens and dogs.

In an effort to develop a transcatheter technique for dilatation of the prostatic urethra without the use of balloons, the feasibility of using Gianturco self-expanding stents was evaluated. Initially, eight human cadaveric prostatic urethras were stented to evaluate the ability of the stent to dilate the lumen. In all cases, the device attained its unconstrained diameter immediately on placement. Subsequently, stents were placed in the prostatic urethra of 12 dogs and followed up for 1 month (four dogs), 3 months (one dog), and 6 months (seven dogs). Five bare straight-end prostheses, one nylon-covered straight-end device, and six flared-end stents were used. Three of the bare straight-end stents migrated during the follow-up, whereas the nylon-covered and flared-end stents did not. Stent diameters greater than 1.3 times the urethral diameter caused moderate to marked edema and inflammation. After 6 months, white deposits were found on the solder points, presumably from electrolysis. Our experience suggests that placement of Gianturco self-expanding stents may be a useful method of dilating and maintaining the luminal diameter of the prostatic urethra, although care must be taken to select the proper stent size.

Adult↗

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

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

Animals↗

Percutaneously placed endovascular grafts for aortic aneurysms: feasibility study.

This limited study addressed the feasibility of treating aneurysms with a new transcatheter endoprosthesis. Aortic aneurysms were experimentally created in six dogs and subsequently bridged with nylon-covered, self-expanding metallic stents. The dogs were followed up for as long as 7 months (median, 22 weeks). In each dog, the graft effectively reconstituted the aortic lumen, excluding the aneurysm. One dog exhibited minimal (less than 1-mm) residual dilatation at the site of the aneurysm 7 months after graft placement. The nylon material acted as a support and template for neointimal encasement, enabling the formation of a new vascular lumen. It also remained porous at the origin of aortic side branches, preserving the visceral blood supply. One of the endovascular grafts failed to expand completely at its distal end, which promoted thrombus formation within the graft and resulted in the occlusion of both renal arteries. The dog was found comatose 48 hours after graft placement and was killed at that time.

Animals↗

Elastic characteristics of the self-expanding metallic stents.

We measured elastic properties of the self-expanding metallic (Gianturco) stent using Hooke's law to characterize the stent with respect to its caliber, length, and radius by a coefficient of stiffness. Although this coefficient was independent of the radius of the stent, we found that it was directly dependent on caliber. For a stent of a particular caliber and length, the fractional change in radius determined the force exerted by the stent. For small radial displacements of the stent, the force required to compress it was directly proportional to the radial displacements; for large displacements, the force depended on a power series of the fractional radial displacement. A hyperbolic function was empirically introduced to approximate this type of relationship between force and radial displacement. We calculated tension and pressure exerted by the stent and suggest the use of our findings with normal vessels.

Angioplasty, Balloon↗

The bird's nest inferior vena cava filter: progress report.

The bird's nest inferior vena cava filter, in clinical trial since 1982, has been placed in 568 patients at risk for pulmonary embolism. Of the 481 patients in whom the filter had been in place for 6 months or more, 440 were followed up clinically. The prevalence of clinically suspected recurrent pulmonary thromboembolism was 2.7% (12 patients) and that of inferior vena cava filter occlusion was 2.9% (13 patients). With the initial filter design, filter migration occurred in five patients. No migrations have occurred in the 147 patients treated with the filter after its modification to improve the anchoring system for greater stability. The bird's nest filter has proved safe and effective in the prevention of pulmonary embolism.

Clinical Trials as Topic↗

Self-expanding endovascular graft: an experimental study in dogs.

An arterial endovascular graft was constructed by wrapping an expandable nylon mesh around a framework of Gianturco self-expanding metallic stents. The devices were passed through a 12-French Teflon catheter and positioned in the normal abdominal aorta of five dogs, two of which also had a device placed in an external iliac artery. At follow-up (1-6 months), all grafts remained patent, even though slight luminal narrowing due to neointimal encasement was noted. Histologically, all grafts were covered by neointimal proliferation at the time of removal. The graft material expanded with the stents, resulting in a tight fit between the graft and the vessel wall. Side branches narrowed but remained open because of the size of the nylon mesh. No migration of the grafts equipped with a barbed lead stent was noted. Expandable nylon mesh can be used as an endovascular graft material when wrapped around a framework of self-expanding stents. The resulting device can be easily delivered via transcatheter techniques, and once placed in a vessel, the nylon acts as a support for neointimal encasement, which forms a new vascular lumen.

Animals↗

Flexible balloon-expanded stent for small vessels. Work in progress.

A new type of flexible, balloon-expanded, stainless steel stent was designed for introduction into small vessels subject to motion. Four stents placed in four dogs were patent at follow-up (4-8 weeks). A fibrocellular proliferation involving the intima and media was responsible for a 20%-25% luminal narrowing observed in all vessels with stents. The stent has longitudinal flexibility, which should permit its insertion into small peripheral, visceral, and coronary arteries.

Animals↗

Self-expanding metallic stents for small vessels: an experimental evaluation.

Thirty-three self-expanding metallic stents were placed in 24 arterial segments of the hind legs and nine arteries of the abdominal viscera in seven dogs. Twelve 5-mm stents, eight 4-mm stents, and 13 3-mm stents were inserted. Follow-up ranged from 4 to 30 weeks. All 4-mm and 5-mm stents were patent at follow-up. Seven (54%) of the 3-mm stents remained patent. Stent wires were completely covered by a proliferation of the intima. No stent migration, occlusion of side branches, or vessel wall perforation was observed. A stent/artery ratio (SAR) was computed using stent and recipient vessel diameters. Good vascular patency was observed when the SAR was less than or equal to 1.2. An SAR greater than 1.2 was associated with immediate spasm, immediate or delayed thrombosis, or excessive intimal proliferation. Selection of correct stent size is a major determinant of patency in small arteries.

Angiography↗

Percutaneous endovascular graft: experimental evaluation.

An arterial endovascular graft was constructed by wrapping a Dacron cylinder around the Gianturco expandable metallic stent. The device was passed through an 11-F Teflon catheter into the normal abdominal or thoracic aortas of nine dogs. At follow-up of 7-35 weeks, all but one graft remained patent. At necropsy, the grafts were almost completely covered by neo-intimal proliferation. Similar proliferation was observed between the graft and the wall of the vessel.

Aneurysm↗

Self-expanding metallic stents: preliminary evaluation in an atherosclerotic model.

The performance of the self-expanding stainless steel (Gianturco) stent in atherosclerotic arteries was examined in a rabbit model. Atherosclerosis was induced by supplementing rabbit chow with 6% peanut oil and 2% cholesterol followed by endothelial disruption of the abdominal aorta with a balloon catheter and continuation on the atherogenic diet for the remainder of the study. Eighteen stents, 1 cm in length and 4 or 5 mm in diameter when fully expanded, were placed in atherosclerotic stenotic lesions in six rabbits. Luminal distention was consistently achieved. At 8 weeks follow-up, no luminal narrowing, stent migration, thrombus formation or branch vessel occlusion had occurred. Atherosclerotic neointimal proliferation occurred around the stent wires following placement, but did not cause significant luminal narrowing.

Animals↗

Early and late results of intracoronary arterial stenting after coronary angioplasty in dogs.

Intimal dissection with acute closure represents the major complication associated with percutaneous transluminal coronary angioplasty (PTCA). Intracoronary stent devices offer the possibility of treatment for this sequela. We developed a balloon catheter-mounted, flexible coil stent for use in such cases. To determine the utility of this device and its immediate and long-term influence on arterial patency, 39 mongrel dogs had the stent placed after PTCA of the left circumflex or left anterior descending coronary arteries. Thirteen animals were treated before and after the procedure with warfarin. In this group there were three early deaths associated with stent thrombosis. Twenty-six animals were subsequently treated before and after with aspirin and dipyridamole. There were no early thrombotic events associated with stent placement in these animals. Late arteriographic examination revealed patent vessels in all dogs. Diameter stenosis for warfarin-treated dogs was 8 +/- 5% (mean +/- SD) at 2 months (n = 9), 6 +/- 4% at 6 months (n = 5), and 11 +/- 7% at 12 months (n = 3). Diameter stenosis for aspirin/dipyridamole-treated dogs was 9 +/- 3% at 2 months (n = 8), 8 +/- 5% at 6 months (n = 12), and 5% at 12 months (n = 1). Light and scanning electron microscopic analyses of stented arteries demonstrated incorporation of the stent wires into the arterial wall. Early findings included mild thrombosis localized to areas of wire entrenchment followed by rapid regrowth of endothelial and/or pseudoendothelial cells over trenches, exposed wires, and elastica.(ABSTRACT TRUNCATED AT 250 WORDS)

Angiography↗

Pulsed arterial infusions. Chemotherapeutic implications.

To simulate the intra-arterial infusion of chemotherapy, ink was infused at a steady rate through a vascular catheter inserted in a transparent tube carrying water at a rate similar to that of arterial blood. The ink ran in one or two discrete streams for 10 to 15 cm before mixing with the water, and there were substantial differences in the concentrations of ink in the water collected from side holes made at various distances from the catheter tip. If the ink was delivered in short pulses, however, it mixed with the water 2 to 3 cm beyond the catheter tip, and the samples collected from the side holes showed similar concentrations of ink. A similar situation may be encountered when chemotherapeutic agents are infused into patients. Therefore, pulsation may produce a more homogeneous drug distribution in the infused tissue. The in vitro data was substantiated in patients by the following: (1) the intra-arterial administration of technetium 99m(99mTc)labeled macroaggregated albumin (MAA) by both steady and pulsed infusions; and (2) changes in the severity of inflammatory skin reactions frequently associated with intra-arterial chemotherapy of the extremities. Improved isotope distribution was noted in 19.3% of the liver and 40% of the extremity studies. Reduced skin reactions were observed in approximately 90% of the extremities receiving pulsed chemotherapeutic infusions.

Antineoplastic Agents↗

Tracheobronchial tree: expandable metallic stents used in experimental and clinical applications. Work in progress.

An expandable stainless steel stent was formulated for use in the treatment of tracheobronchial stenosis, tracheomalacia, and airway collapse following tracheal reconstruction. The stents were placed through an endotracheal tube into the trachea and bronchi of 11 healthy dogs. The stents expanded over time, substantially increasing the diameter of the lumen. Slight migration occasionally occurred, while an inflammatory reaction was noted in each animal. The stents were successfully used in the treatment of two cancer patients to dilate a postoperative bronchial stenosis that caused pneumonia and to support a tracheal graft that collapsed with respiration. Because of the stent migration in experimental studies, designs are being tested to develop stents with greater stability. These stents may be effective in overcoming stenosis caused by scarring, extrinsic compression, and collapse of reconstructed tracheobronchial structures.

Adult↗

Stenosis of the vena cava: preliminary assessment of treatment with expandable metallic stents.

To test the ability of Gianturco expandable metallic stents to dilate and maintain patency in stenotic venae cavae, stenosis of the inferior vena cava was created in seven mongrel dogs by the percutaneous injection of absolute ethanol into the paravascular retroperitoneal space. Gianturco stents, placed across the stenotic segment, resulted in successful dilatation with improved hemodynamics in four dogs. The stents failed to dilate an occluded vena cava in one dog; in the remaining dogs, stent placement was complicated by early migration and occlusion. Gianturco stents were placed in two patients, one with superior vena cava syndrome and one with retroperitoneal fibrosis that obstructed the inferior vena cava, and resulted in immediate relief of presenting symptoms. These results should be viewed cautiously, but further investigation into the clinical use of the stents is indicated, especially for patients for whom other treatments are difficult.

Animals↗