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Biomedical subjects

S O Trerotola

Publications and source records attributed to S O Trerotola.

At least 19 recordsLinked to original sources
PubMed2001

The effects of a mechanical thrombolytic device on normal canine vein valves.

PURPOSE: To determine if the Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) causes damage to normal vein valves. MATERIALS AND METHODS: Ten lateral saphenous veins in five dogs were studied with descending venography with use of a wedge balloon catheter positioned above 48 valves (demonstrating 51 valves) before and after five antegrade passes each with an over-the-wire (0.025-inch), 6.5-F, 9-mm-diameter PTD. Vein diameters were 3.2-11.4 mm (mean, 5.9 mm). Contrast matter was injected at incremental rates from 3 to 15 mL/min during continuous pressure monitoring. Imaging was performed with digital subtraction angiography at a rate of 1 frame/sec. The time to valve reflux was determined by noting the frame at which reflux was first seen through the valve. The time to reflux and pressure required to reflux were compared before and after the PTD passes. All vessels were explanted and evaluated histologically for presence or absence of endothelial loss, thrombus formation, inflammation, or valve degeneration. Four veins in two animals were studied with venography to determine the variability of the venographic method. These veins thrombosed during venography and therefore served as positive pathologic controls. In two animals, one vein was studied with venography and one was not studied to provide pathologic controls. RESULTS: With use of two physiologic tests of valve function, 77% of valves had minimal or no damage as assessed by valve competency and 80% had minimal or no damage as demonstrated by the change in the pressures the valve can withstand before reflux. Twenty-six of 51 valves (51%) had no difference or later reflux after PTD use. Thirteen (26%) refluxed 1 second earlier after PTD use and 12 (23%) refluxed > or =2 seconds earlier (six at 2, four at 3, and two at 4). Four of the six valves with more than a 2-second difference in reflux times were in valves with diameters less than 4.2 mm. All these vessels were smaller than 7 mm in diameter. Twenty-one of 48 valve levels (44%) had no difference or sustained higher pressures before reflux after PTD use. Seventeen (36%) had a pressure drop of <10 mm Hg; five (10%) had drops of 12-24 mm Hg; and five (10%) had drops of more than 40 mm Hg. There was a significant difference in endothelial loss, thrombus formation, and inflammation between experimental veins, the veins with thrombus, the venography controls, and the normal vein controls. There was significant difference only in terms of inflammation when the experimental group was compared to the thrombosis group. CONCLUSION: The antegrade use of the PTD across normal canine vein valves does not cause physiologically significant damage in valves 7 mm or larger in diameter in this animal model.

Animals↗
PubMed2001

Preclinical in vivo testing of the Arrow-Trerotola percutaneous thrombolytic device for venous thrombosis.

PURPOSE: To test the safety and efficacy of using the Arrow-Trerotola percutaneous thrombolytic device (PTD) for treating deep vein thrombosis (DVT) in an animal model. MATERIALS AND METHODS: An established canine model of iliocaval subacute thrombosis was used. Thrombosis was caused by balloon occlusion of the infrarenal inferior vena cava (IVC) for 7 (n = 12), 10 (n = 1), or 17 (n = 1) days. Treatment was performed with use of an 8-F, over-the-wire (0.035-inch) PTD with a 15-mm-diameter basket. The procedure was performed without IVC filtration. Two acute procedures were performed and 12 procedures were intended as survival procedures with 30-day follow-up. Pulmonary arteriography, blood gases, and pulmonary artery pressure measurement were performed before and after the procedure, and at follow-up. The animals were killed after the follow-up procedure and their IVC, iliac veins, and lungs were removed and examined histologically. Heparin was used intraprocedurally but thrombolytic agents were not used. Low-molecular-weight heparin was given daily after the procedure. RESULTS: Thrombolysis was completely (12 of 13) or partially (one of 13) successful in all animals in the 7- and 10-day groups, but was unsuccessful in the animal in the 17-day group (n = 1). Variable amounts of segmental and subsegmental pulmonary emboli were found in all animals with small increases in pulmonary artery pressure. Two animals died within 6 days of the procedure, possibly due to pulmonary emboli. At 30-day follow-up, IVC patency was preserved in 80% (eight of 10) of animals, but significant caval narrowing due to intimal hyperplasia was noted at follow-up. All pulmonary emboli had resolved angiographically at follow-up, but evidence of recanalized or resolving pulmonary thromboemboli was found in seven of the 12 surviving animals. No acute vascular injury (eg, perforation) occurred. CONCLUSION: The modified PTD used in this study is effective in treating subacute (<7 days old) venous thrombosis, but temporary filtration will probably be necessary to keep pulmonary emboli to a minimum during the procedure. The 30-day patency is encouraging. The results in this animal model indicate that the Arrow-Trerotola PTD may be useful in the percutaneous treatment of DVT in humans.

Animals↗
PubMed2001

Increase in hepatic arterial blood flow after transjugular intrahepatic portosystemic shunt creation and its potential predictive value of postprocedural encephalopathy and mortality.

PURPOSE: To determine (i) whether there is a significant increase in hepatic artery blood flow (HABF) after transjugular intrahepatic portosystemic shunt (TIPS) creation and (ii) whether the extent of incremental increase in HABF is predictive of clinical outcome after TIPS creation. MATERIALS AND METHODS: Prospective, nonrandomized, nonblinded duplex Doppler ultrasound (US) examinations were performed on 24 consecutive patients (19 men; Child Class A/B/C: 4/12/8, respectively) with a mean age of 52.8 years who were referred for TIPS creation for variceal bleeding. Peak hepatic artery velocity and vessel dimensions were used to calculate the hepatic arterial blood flow (HABF) before and after TIPS creation. Patients were clinically followed in the gastrohepatology clinic and TIPS US surveillance was performed at 1 and 3 months to assess shunt function. The extent of incremental increase in HABF was analyzed as a predictor of post-TIPS encephalopathy and/or death. RESULTS: The technical success rate of TIPS creation was 100%. The shunt diameters were either 10 mm (n = 11) or 12 mm (n = 13). TIPS resulted in a significant reduction in the portosystemic gradient from 24.3 mm Hg +/- 5.7 to 9.3 mm Hg +/- 2.9 (P <.001). The hepatic artery peak systolic velocity and HABF increased significantly after TIPS creation, from 60.8 cm/sec +/- 26.7 to 121 cm/sec +/- 51.5 (P <.001) and from 254.2 mL/min +/- 142.2 to 507.8 mL/min +/- 261.3 (P <.001), respectively. The average incremental increase in HABF from pre-TIPS to post-TIPS was 253.6 mL/min +/- 174.2 and the average decremental decrease in portosystemic gradient was 15.0 mm Hg +/- 5.3, but there was no significant correlation (r = 0.04; P =.86) between the two. All shunts were patent at 30 and 90 days without sonographic evidence of shunt dysfunction. After TIPS creation, new or worsened encephalopathy developed in five patients at 30 days and in an additional three at 90 days. They were all successfully managed medically. Three patients (12.5%) died within 30 days of the TIPS procedure. The extent of incremental increase in HABF after TIPS was variable and did not correlate with the development of 30-day and 90-day encephalopathy (P =.41 and P =.83, respectively) or 30-day mortality (P =.2). CONCLUSIONS: HABF increases significantly after TIPS but is not predictive of clinical outcome. The significance of the incremental increase is yet to be determined.

Adult↗
PubMed2001

Mechanical thrombolysis of venous thrombosis in an animal model with use of temporary caval filtration.

PURPOSE: To test the effect of temporary caval filtration on pulmonary emboli when a mechanical thrombolytic device is used to treat venous thrombosis and to test the effects of a modified device on caval patency at 30-day follow-up. MATERIALS AND METHODS: In a canine model of iliocaval subacute thrombosis, mechanical thrombolysis was performed with use of an 8-F over-the-wire Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) with a 9-mm (iliac) or 15-mm (inferior vena cava [IVC]) basket. In six procedures, the device was made of nitinol monofilament, and in another six, it was made of braided stainless steel. All procedures were performed with a nitinol expandable sheath (temporary filter) in the suprarenal IVC. Low-molecular-weight heparin was given daily after the procedure. Venography, pulmonary arteriography, measurement of blood gases, and pulmonary artery (PA) pressure measurement were performed before and after the procedure and at 30-day follow-up. Pulmonary arteriograms from the group treated with stainless-steel devices were compared to those from an earlier group of animals in which the identical procedure was performed without caval filtration. The IVC was examined histologically. RESULTS: Thrombolysis was successful in all animals. Rare segmental and subsegmental pulmonary emboli (PE) were seen arteriographically; compared to procedures without filters, there was a significant reduction in PE (P <.002). However, a mild increase in pulmonary artery pressure, decrease in pH, and increase in pCO(2) were observed postprocedurally. At 30-day follow-up (n = 11), IVC patency was preserved in 45% (n = 5) of animals overall. Caval patency was significantly better in animals in which the combination of stainless-steel devices was used (five of six = 83% vs zero with nitinol device; P =.015). Histologically, the stainless-steel device caused little intimal injury and fibrosis-less than that seen with the nitinol device. CONCLUSIONS: Temporary filtration reduces, but does not completely eliminate, PE during mechanical thrombolysis. The stainless-steel device results in less intimal injury and better caval patency than the nitinol device.

Animals↗
PubMed2001

Recent trends in central venous catheter placement: a comparison of interventional radiology with other specialties.

The authors determined changing trends and growth in tunneled and nontunneled central venous catheter placement procedures. With use of Medicare billing data for tunneled and nontunneled catheter placement, a comparison was made among interventional radiology (IR), surgery, anesthesia, and internal medicine. There has been substantial growth in the placement of central venous catheters. Currently, a minority of these procedures are performed in IR departments. However, there has been significant growth in the radiologic placement of both types of catheters.

Catheterization, Central Venous↗
PubMed2001

Short-term patency and safety of an expanded polytetrafluoroethylene encapsulated endoluminal device at the venous anastomosis of a canine arteriovenous graft model.

PURPOSE: To determine the safety and short-term patency of a polytetrafluoroethylene (PTFE)-encapsulated carbon-lined endoluminal device (ED) deployed across the venous anastomosis of arteriovenous conduits. MATERIALS AND METHODS: Arteriovenous grafts (n = 16) were created between femoral arteries and veins in eight female canines and allowed to mature 30 days +/- 5 (SD). Five were excluded before implantation because of thrombosis or intragraft stenosis. Deployment was conducted in the remaining 11 anastomoses. Fistulography and intravascular ultrasound (IVUS) were performed before and after the procedure and 1 month postimplantation. Stent migration, apposition, and stenosis were evaluated. The angle of the anastomosis was compared before and after deployment and at follow-up. Mural thrombus thickness, percentage of surface covering, and percentage of endothelialization within the device were measured histologically. RESULTS: There was no significant migration. By explant, all devices were completely apposed. Stenosis occurred in three of nine grafts. The angle of the venous anastomosis decreased by 29.5 degrees (posteroanterior) and 32.4 degrees (oblique) after ED deployment. There was a further decrease of 6.1 degrees (posteroanterior) and 3.2 degrees (oblique) during the 4-week follow-up period. Hemostasis was difficult to achieve in this animal model. Five required more than 1 hour to achieve hemostasis manually. Six in three animals were closed with a Perclose device, achieving immediate hemostasis; however, three (one in each animal) re-bled intermittently 2 weeks after implantation for an average of 9.3 days. The puncture site of each graft that bled was radiographically shown abnormal. CONCLUSION: The ED can be deployed without stent migration and is completely apposed and patent after 4 weeks. Although bleeding was a problem with this animal model, delayed bleeding complications associated with puncture site abnormalities were seen only in grafts closed with a percutaneous suturing device.

Animals↗
PubMed2001

Outcome of polyester cuff retention following traction removal of tunneled central venous catheters.

PURPOSE: To elucidate the factors that contribute to cuff retention during traction removal of tunneled catheters, as well as to determine the risk of complication associated with polyester cuff retention. MATERIALS AND METHODS: A total of 428 tunneled, cuffed catheters were removed with traction and local anesthesia. Polyester cuff retention was recorded when it occurred, and the effects of cuff retention were determined at a mean follow-up of 250 days. Statistical analysis was performed to determine the variables influencing cuff retention. RESULTS: Traction removal was successful in 428 (100%) patients. Of 428 catheters removed, 41 (10%) cuffs were retained. Silicone 10-F double-lumen and 9.6-F single-lumen catheters had a higher rate of cuff retention (27 [32%] of 84 and nine [39%] of 23, respectively) than did the split-tip polyurethane hemodialysis catheter (two [1%] of 196; P <.001). Cuff retention rates among other catheter types compared with that of the polyurethane catheter were not significantly different. Duration of catheter dwell did not significantly influence cuff retention. Of 41 retained cuffs, three required removal with cutdown for cuff migration to the exit site, which inhibited healing (n = 1); for suspected infection (n = 1); or for cosmetic purposes as requested by the patient (n = 1). The remaining patients had no complications associated with cuff retention. CONCLUSION: Traction removal of smaller-bore silicone catheters is more likely to result in cuff retention than removal of larger silicone and polyurethane catheters, and cuff retention is usually inconsequential.

Catheterization, Central Venous↗
PubMed2001

Renal arterial stenosis in renal allografts: retrospective study of predisposing factors and outcome after percutaneous transluminal angioplasty.

PURPOSE: To determine the predisposing factors to transplant renal arterial stenosis (TRAS) and assess the outcome of percutaneous transluminal angioplasty (PTA) as the primary treatment. MATERIALS AND METHODS: Of 831 renal allograft recipients (584 cadaveric, 247 living related) between January 1991 and December 1998, 72 had hypertension and/or renal dysfunction. All 72 underwent arteriography, and their medical charts were retrospectively reviewed. RESULTS: Prevalence of TRAS was 3.1% (26 of 831). Technical success rate of PTA was 94% (16 of 17), and clinical success rate was 82% (14 of 17). Those with renal dysfunction had a mean pre-PTA creatinine value of 2.6 mg/dL (230 micromol/L) +/- 0.5 (SD) versus a 1-week post-PTA value of 1.7 mg/dL (150 micromol/L) +/- 0.3 (P <.001). Of those with hypertension, all but one had substantial improvement in mean diastolic blood pressure. At 26.9 months mean follow-up in 16 patients with successful PTA, two stenoses reoccurred, and two grafts were lost to chronic rejection. TRAS was present in 14 of 45 end-to-side anastomoses and 12 of 27 end-to-end anastomoses (P =.31), and TRAS was more prevalent in cadaveric grafts (24 of 584) than in living related grafts (two of 247). In cadaveric grafts, the mean cold ischemia time was 29.0 hours +/- 6.9 in those with TRAS (n = 24), as compared with 25.5 hours +/- 8.1 in those with no TRAS (n = 39; P = .35). Seven of 17 patients with acute rejection and six of 35 with chronic rejection had TRAS. CONCLUSION: Primary treatment of TRAS with PTA has good intermediate-term results. TRAS is more prevalent in cadaveric allografts with long cold ischemia time.

Adult↗
PubMed2000

Hemodialysis catheter placement and management.

Hemodialysis catheters are an integral part of the delivery of hemodialysis. While catheters play an important role in the patient undergoing hemodialysis, catheters should be considered a bridge to more permanent forms of dialysis access in most patients. Recent advances in catheter technology, access techniques, and choice of access sites have improved outcomes associated with hemodialysis catheters. The placement and management of hemodialysis catheters by interventional radiologists have played an important role in these advances, and interventional radiologists are taking an increasingly active role in the research and development of catheters and catheter insertion techniques. The present status of hemodialysis catheters is reviewed.

Catheterization, Central Venous↗
PubMed2000

Tunneled infusion catheters: increased incidence of symptomatic venous thrombosis after subclavian versus internal jugular venous access.

PURPOSE: To compare the incidence of symptomatic venous thrombosis after tunneled infusion catheter placement via the internal jugular vein (IJV) versus the subclavian vein (SCV). MATERIALS AND METHODS: A retrospective analysis was performed of 774 catheters placed. Only patients with complete follow-up were included, which yielded a population of 279 catheters in 238 patients (166 in the SCV, 113 in the IJV; total of 26,242 catheter days). All catheters were placed by interventional radiologists with ultrasonographic (in IJV) or venographic (in SCV) guidance. RESULTS: Initial complications were limited to one pneumothorax in the SCV group and one episode of oversedation in the IJV group. There was no difference in infection rates between the two sites (SVC vs IJV: 0.25 vs 0.32 per 100 catheter days; P >.99). The mean dwell time was slightly longer for SCV catheters (103 days) than for IJV catheters (79 days) (P =.04). Venous thrombosis developed in 13% of patients (0.12 per 100 catheter days) with an SVC catheter placed as compared with in 3% (0.04 per 100 catheter days) with an IJV catheter (P =.018). This difference persisted after adjustment for catheter size and side of placement (P =.025). The mean time to thrombosis was 36 days for SCV catheters and 142 days for IJV catheters. CONCLUSION: The IJV is the preferred site for tunneled infusion catheter placement because of the lower incidence of symptomatic venous thrombosis.

Catheterization, Central Venous↗
PubMed1999

Modified use of the arrow-trerotola percutaneous thrombolytic device for the treatment of thrombosed hemodialysis access grafts.

PURPOSE: To assess the safety and efficacy of using the Arrow-Trerotola percutaneous thrombolytic device (PTD) as the sole means of mechanical thrombolysis in hemodialysis access grafts, including in situ treatment of the arterial plug. PATIENTS AND METHODS: Fifty consecutive patients (22 women, 28 men; mean age, 58 years; mean graft age, 29 months), in whom mechanical thrombolysis of a thrombosed hemodialysis access graft using the PTD was planned, were included in the study. In all patients, the PTD was used to treat the arterial plug in situ at the arterial anastomosis, instead of using a Fogarty catheter to reposition the plug, as indicated in the PTD product labeling. Prospective data collection included demographic information, technical details of the procedure, immediate outcomes, and complications. Patients were followed for 3 months using definitions and data forms that were identical to those used in the original clinical trial of the PTD. A sample of procedures drawn from the PTD clinical trial database (n = 54) served as control. RESULTS: Immediate technical patency was 100%. Complications included arterial embolization (6% versus 2% control; P = NS; all successfully treated with backbleeding); venous rupture (6% versus 2% control; P = NS); and sepsis (n = 1), probably due to occult graft infection. Adjunctive therapy with an Adherent Clot catheter was needed in two procedures (4%). Three month patency using life-table analysis was 42% (versus 39% control; P = NS). The number of subsequent interventions (surgical/percutaneous) to the arterial limb of the graft did not differ from the PTD trial, and no native arterial stenoses were detected during the follow-up period. CONCLUSIONS: The PTD is safe and effective when used as the sole means of mechanical thrombolysis of hemodialysis grafts. Treating the arterial plug in situ with the PTD eliminates the need for a Fogarty or Adherent Clot catheter in 96% of procedures. A slight increase in arterial embolic complications was observed but these were easily treated with backbleeding.

Adult↗
PubMed1999

Randomized comparison of high-flow versus conventional hemodialysis catheters.

PURPOSE: To evaluate short-term flow rates achieved with a new split-tip polyurethane hemodialysis catheter. PATIENTS AND METHODS: This was a prospective, randomized, nonblinded study. Patients referred for a tunneled-dialysis catheter received either a conventional silicone (Bard Hickman 13.5 F) if randomized to the control group, or a split-tip, high-flow polyurethane (MedComp AshSplit 14.5 F) catheter if randomized to the study group. Effective flow rates (QbEff) and recirculation were measured with use of ultrasonic dilution at pump settings (Qb) of 200, 300, 350 and 400 mL/min, as well as maximum Qb (QbMax, up to 500 mL/min) sustainable for at least 3 minutes. Measurements were repeated weekly for 6 weeks. Procedure times and initial and late complications were recorded. RESULTS: Twelve patients were enrolled in each group, 11 and eight completed the study in the test and control groups, respectively. Insertion complications, limited to the split-tip group, included asymptomatic air embolus (n = 1), prolonged tunnel bleeding (n = 2), and kinking (n = 2). Recirculation in both groups was low (mean < 6% at all flow rates). QbMax was 499 mL/min in the Ash group and 470 mL/min in the Hickman group. A repeated measures analysis of variance was used. Adjusted (for week) mean effective flow rates (Qbeff, mL/min) were as follows: at Qb = 200, Ash = 211, Bard = 211, P = .93; at Qb = 300, Ash = 301, Bard = 292, P = .28; at Qb = 350, Ash = 341, Bard = 314, P = .03; at Qb = 400, Ash = 375, Bard = 329, P = .01; at QbMax, Ash = 422, Bard = 359, P = .0005. CONCLUSION: Both catheters delivered flows within the acceptable range indicated by the Dialysis Outcomes Quality Initiative. The split-tip catheter is capable of higher flow rates (Qb and QbEff) compared with the conventional catheter, which may allow more efficient dialysis. Insertion complications appear to be higher with the new design.

Blood Flow Velocity↗
PubMed1999

Brachytherapy for the prevention of stenosis in a canine hemodialysis graft model: preliminary observations.

PURPOSE: To determine whether gamma brachytherapy can prevent in-stent stenosis in hemodialysis grafts. MATERIALS AND METHODS: Six-millimeter polytetrafluoroethylene arteriovenous grafts were created bilaterally in six dogs. After 1 month, Wallstents spanning the venous anastomosis were placed to accelerate restenosis. Gamma irradiation (12 Gy) was delivered endoluminally to one of the two grafts by using an iridium 192 source; thus, each animal served as its own control. Fistulography was performed monthly for 10 months or until graft thrombosis, with measurement of stenosis at each time point. At the conclusion of the study period, the treated area was examined histologically, and a computer model was used to calculate the volume of intimal hyperplasia. RESULTS: Delayed stent migration resulted in exclusion of one dog. In the remaining five dogs; maximum stenosis across all time intervals was less for the treated side (P < .04), and the volume of intimal hyperplasia was less for the treated side (P < .045). In one animal studied at 1 year, this trend reversed in terms of percentage stenosis but not total neointimal volume. CONCLUSION: Brachytherapy with 192Ir (gamma) delivered at the time of stent placement reduces restenosis in this hemodialysis graft model, but, depending on the parameter evaluated (stenosis vs total volume of neointima), the benefit may wane or even reverse with time.

Angiography↗
PubMed1999

Hemodialysis graft: use as access for upper and lower extremity arteriography and interventional procedures--initial experience.

Functioning hemodialysis grafts were used as access sites for peripheral vascular arteriography and interventional procedures. In 11 patients with end-stage renal disease and ischemia, upper extremity (n = 8) or lower extremity (n = 3) arteriography was performed successfully. Angioplasty and other interventional procedures were performed via the same route in two of the patients. No bleeding complications occurred, and all patients were ambulatory immediately after the procedure.

Angiography↗