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Biomedical subjects

H E Kambic

Publications and source records attributed to H E Kambic.

13 recordsLinked to original sources

Effects of design geometry of intravascular endoprostheses on stenosis rate in normal rabbits.

To investigate the effects of gaps between the individual wire coils of a shape memory Nitinol alloy intravascular endoprosthesis, 20 stents with and without gaps were implanted transluminally into the infrarenal abdominal aortas of 10 normal rabbits after balloon angioplasty. Digital subtraction angiography (DSA) was done at 4, 12, 16, 20, and 24 weeks after stent implantation to examine the stenosis rate and major side branch patency. Stenosis rate within stents with gaps were significantly lower than those without gaps: 8.1 +/- 5.0% versus 15.0 +/- 6.8% at 12 weeks, 13.6 +/- 6.0% versus 26.0 +/- 9.4% at 24 weeks by DSA, p greater than 0.005 and p less than 0.01 respectively. The maximum and mean neointimal thickness measured histologically at the time of animal death correlated significantly to the narrowest diameter obtained from the DSA studies, (r = 0.84 and r = 0.79, respectively, p less than 0.01). Greater hyperplasia of the neointima was evident in the stented arterial segments with stents without gaps compared with those with gaps (83 +/- 22 versus 187 +/- 46 microns mean thickness, p less than 0.001). The patency rate of the side branches in the stented arterial segment was significantly (p less than 0.05) higher in stents having gaps. These results suggest that the placement of gaps between wire pitches reduced the neointimal thickness within stents and prevented the obstruction of arterial side branches.

Angioplasty, Balloon

A model for evaluating the strength of bones lengthened by distraction osteogenesis.

In an effort to evaluate the strength of bones lengthened by distraction osteogenesis, a modified Ilizarov-type external fixator was applied to the right tibiae of five adult mongrel dogs. Diaphyseal corticotomies were performed, and distraction (lengthening) was carried out at a rate of approximately 1 mm per day for 20 days. After completion of the lengthening, the animals were killed, the fixators were removed, and the right and left tibiae were harvested and stripped of soft tissue. The ends of all harvested bones were fixated in polymethylmethacrylate to allow testing on a materials testing system (MTS) machine. Testing under torsional loads was performed on the MTS machine (50 degrees maximum angle of rotation at ten seconds) until failure. The right tibiae were lengthened an average of 12 mm (range, 7-15 mm). The slopes of the linear portion of the torque versus rotation curves were determined. A comparison of slopes revealed a mean change in stiffness between test and control bones of 20.32% (range, 0.64%-40.5%). All tibiae exhibiting mature regenerate bone demonstrated stiffness greater than the matched controls (range, 0.64-24.09% stiffer). Four of five dogs had problems with proximal and distal ring impingement. This study presents a reproducible model for evaluating the strength of bones lengthened by distraction osteogenesis. The lengthened bones that exhibited bony or mature regeneration were as strong as the control bones.

Animals

Vascular stenting in normal and atherosclerotic rabbits. Studies of the intravascular endoprosthesis of titanium-nickel-alloy.

Percutaneous transluminal balloon angioplasty would be more effective if the rate of recurrent stenosis were reduced. To evaluate the prevention of restenosis after percutaneous transluminal angioplasty, intravascular endoprosthetic stents of titanium-nickel-alloy were implanted transluminally in seven normal and 21 atherosclerotic rabbits. In normal rabbits, a 3.5-mm diameter stent was implanted in the aorta and a 2.5-mm diameter stent in the right iliac artery, which were followed with serial angiograms from 6 weeks (n = 7) to 8 months (n = 4). There was a mean stenosis of 13.1% in the 2.5-mm and 13.6% in the 3.5-mm stent. There was no significant narrowing compared with the adjacent control segments of artery; histopathology showed a thin, fibrous neointima with smooth muscle cells. Each atherosclerotic rabbit was balloon dilated at two separate stenotic sites; each site was 2.0 cm in length. The aortic site (with 28.8 +/- 13.8% mean stenosis [+/- SD]) was dilated with a 3.5-mm balloon, and the iliac site (with 36.5 +/- 14.2% stenosis) was dilated with a 2.5-mm balloon. In each site, an intravascular stent of corresponding diameter and 7-mm length was implanted in one half of the dilated segment, assigned randomly, and the other half served as the angioplasty control. Angiographically observed restenosis rates and the corresponding histopathology were similar in the atherosclerotic segments that had angioplasty alone versus the atherosclerotic segments that had angioplasty plus stenting. The mean neointimal thickness in the aortas and iliac arteries, respectively, measured 247 +/- 181 microns (+/- SD) and 218 +/- 77 microns after 6 weeks (n = 8) versus 321 +/- 168 and 308 +/- 189 microns after 20 weeks (n = 5, p = NS). At 20 weeks follow-up, there was 29.1 +/- 29.8% (median, 16.4%) stenosis in the aortic stent versus 38.9 +/- 24.1% (median, 34.0%) stenosis in the percutaneous transluminal angioplasty control segment of aorta (n = 5, p = NS) and 81.4 +/- 25.5% stenosis in the iliac artery stent versus 89.3 +/- 15.3% stenosis in the PTA control segment of the right iliac artery (n = 5, p = NS). Comparing stenotic arterial segments treated with angioplasty alone with angioplasty plus intravascular stenting in the atherosclerotic rabbits showed that there was no significant difference in either the histopathologic changes or the restenosis rates.

Alloys

Titanium-nickel intravascular endoprosthesis: a 2-year study in dogs.

Twelve 5-mm-internal-diameter intravascular endoprostheses of noncorrosive, shape-memory titanium-nickel (TiNi) alloy were delivered transluminally by catheter and implanted in the iliac (n = 10) and femoral (n = 2) arteries of six normal dogs for either 1 or 2 years in order to evaluate the implantation technique and long-term effects. The patency rates were as follows: at 1 month, 92% (11/12); at 1 year, 100% 11/12 widely patent; 1/12 recanalized); and at 2 years, 100% (3/4 without stenosis; 1/4 with 20% stenosis). No migration, erosion, inflammation, surface thrombus, or stenosis of the side branches was seen; an absence of untoward angiographic and histopathologic effects was detected at 1 and 2 years. The neointima was completely endothelialized, without changes in thickness over time, 229.3 +/- 127.6 microns after 1 year and 223.3 +/- 216.7 microns after 2 years (p = not significant). The neointimal layer became thicker toward its distal aspect (p less than or equal to .05). Satisfactory delivery, long-term patency, and biocompatibility (manifested as a thin, stable neointima) were observed for the TiNi intravascular endoprosthesis at 1 and 2 years.

Animals

A simple in vitro screening test for blood compatibility of materials.

An in vitro closed-cell kinetic blood-coagulation test was developed and used to evaluate the blood compatibility of materials. The test compares the clotformation rate on a test surface to that of a control material, Silastic. This method avoids anticoagulants, blood flow variations, and the exposure to air and other foreign surfaces. Eight pairs of cells are sequentially evaluated as to the weight of thrombus formed, the amount of unclotted blood, and the reduction in platelet count of the blood exposed to both the test materials and the control. These data are used to calculate a relative index whereby materials can be rated quantitatively as to the rate of clot formation on their surface. The order of decreasing clot formation on one group of materials studied was as follows: biolized (Imai et al., Trans. Amer. Soc. Artif. Int. Organs, 17, 6, 1973) poly (ether urethane), segmented polyurethane, formaldehyde-treated pericardium, Hydron, glutaraldehyde-treated pericardium, biolized natural rubber, Hexsyn, heparinized natural rubber, Silastic, and natural rubber. Urethane and aldehyde-treated natural tissue had a lower percentage of red thrombus formation. These results generally correlate with in vivo observations.

Biocompatible Materials

Intravascular endoprostheses. Effect of surface geometry on restenosis and side branch patency.

To investigate the effects of gaps between the wire pitches of a shape memory Nitinol alloy intravascular endoprosthesis (IVEP), 42 stents with and without gaps were implanted transluminally into the infrarenal abdominal aortae of 11 normal and 10 atherosclerotic rabbits. Digital subtraction angiography was done every 4 weeks to examine the restenosis rate and major side branch patency. Restenosis rates within IVEPs with gaps were significantly lower than in stents without gaps in both normal and atherosclerotic rabbits. The side branch patency rate was significantly higher with IVEPs having gaps. These results suggest that the placement of gaps between wire pitches reduced the restenosis rate within IVEPs, and prevented the obstruction of major side branches.

Angioplasty, Balloon

A titanium-nickel alloy intravascular endoprosthesis. In vitro studies.

In order to evaluate the implantation technique and reliability of conversion at different temperatures, a miniaturized intravascular endoprosthesis (IVEP) composed of thermal shape-memory effect TiNi alloy was delivered via a catheter into a 37 degrees C water mock circulatory loop (MCL) with a flow of 100 ml/min. The 2.5 mm diameter wire coil IVEP was torsion reduced to 1.4 mm, mounted on a modified balloon angioplasty catheter, and delivered into the MCL. Shape-memory conversion was activated thermally by injecting normal saline (3, 5, or 10 ml) at 45 degrees, 50 degrees, 55 degrees, 60 degrees, 65 degrees, or 70 degrees C, while the local temperature (Tp) at the endoprosthesis site was monitored by a thermocouple. Inconsistent completed conversions of the IVEP were produced by injecting 10 ml of 60 degrees C, or 5 ml of 65 degrees C normal saline, which raised the Tp to 45 degrees to 53 degrees C. Complete conversion of the IVEP to 2.5 mm was produced consistently by injecting 10 ml of 65 degrees C or 5 ml of 70 degrees C saline, which raised Tp to 55 degrees C for less than 1 sec. This moderate Tp (55 degrees C) for such a short duration was shown to be a reliable method for remote conversion of the IVEP after catheter delivery. Knowledge of the minimum temperature and volume for consistent, complete conversion of the IVEP has permitted simple, safe conversion during in vivo studies. Delivery after balloon angioplasty is envisioned to either treat acute dissection with occlusion or to prevent chronic restenosis, in order to further improve the safety and efficacy of balloon angioplasty procedures.

Alloys