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Biomedical subjects

G S Roubin

Publications and source records attributed to G S Roubin.

At least 73 records · Page 4Linked to original sources
PubMed1997

Comparison of balloon angioplasty versus debulking devices versus stenting in right coronary ostial lesions.

Angioplasty of aorto-ostial stenosis is associated with lower procedural success and a higher complication rate. The aim of the present study was to compare the acute and long-term results of balloon and new device angioplasty in 110 consecutive patients with right coronary ostial lesions. Patients were divided into 3 groups according to the angioplasty device used: group I (balloon only, n = 26), group II (debulking devices including excimer laser, directional and rotational atherectomy, n = 26), group III (stent, n = 58). Procedural success was highest in group III (96%) followed by group I (88%), and group II (77%). In-hospital complications were similar among the groups (p = NS). Patients in group III achieved the highest acute gain (2.61 mm) followed by groups II (1.92 mm), and I (1.39 mm, p <0.05). During follow up, target lesion revascularization and/or bypass surgery was required in 24% of patients in group III compared with 47% and 40% in groups I and II, respectively (p <0.05). Cardiac-event free survival was highest in the stent group (74%, p <0.005) and was similar between the balloon (39%) and debulking device groups (45%). Thus, among the currently available technologies, stenting of right coronary ostial lesions appears to provide excellent angiographic and long-term results.

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PubMed1997

Elective stenting of the extracranial carotid arteries.

BACKGROUND: Surgical endarterectomy has been shown to be superior to medical management in the management of severe carotid stenosis in both symptomatic and asymptomatic patients. Endarterectomy, although effective, does have limitations, and percutaneous techniques may offer an alternative method of treatment. METHODS AND RESULTS: The feasibility and safety of percutaneous carotid angioplasty and elective (primary) stenting was evaluated prospectively in a consecutive series of 107 patients. One hundred twenty-six carotid arteries with significant stenosis were treated. This series represented a high-risk subset that included patients with previous ipsilateral endarterectomy and severe medical comorbidity. Forty-five percent of the patients were referred by surgeons. Patients had independent neurological examinations before and after the procedure and follow-up cerebral angiography at 6 months. The mean (+/- SD) stenosis was reduced from 78 +/- 14% to 2 +/- 5%. There were 7 minor strokes, 2 major strokes, and 1 death during the initial hospitalization and first 30 days after the procedure. For the combined end point of all strokes and death, the incidence was 7.9%. For ipsilateral major stroke and death, the incidence was 1.6%. There were no strokes during the follow-up period. Mean angiographic stenosis at 6 months in 81 patients was 18 +/- 16% (range, -21% to 57%). Four (4.9%) of these 81 patients had asymptomatic restenosis. Five asymptomatic patients had repeat intervention: 2 had angioplasty for restenosis, 2 had angioplasty for stent deformation, and 1 had endarterectomy for restenosis. CONCLUSIONS: In a high-risk group of patients, percutaneous carotid angioplasty and stenting are feasible and can be performed with low restenosis and repeat intervention rates.

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PubMed1997

Combined coronary and bilateral carotid stenting: a case report.

We describe a patient who underwent stenting of both internal carotid arteries and two coronary arteries. Two combined carotid and coronary procedures were done 4 wk apart to revascularize the patient. The first procedure was complicated by a minor stroke with good recovery. At 6 mo of follow-up, he is asymptomatic and without angiographic restenosis.

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PubMed1997

Palmaz stent compression in patients following carotid artery stenting.

UNLABELLED: Carotid artery stenting is being investigated as a therapeutic strategy for the management of bifurcation stenosis. Palmaz stents were deployed successfully in the carotid arteries of 112 patients using high-pressure balloon inflations. In 11 out of 70 patients who came for 6-mo follow-up angiography, a stent collapse was noted. Carotid ultrasound was able to detect stent collapse in only two patients at follow-up. Only one patient who had collapse of stent along its entire length was symptomatic at follow-up. Repeat balloon angioplasty was performed in 5 patients, 3 of whom had a Wallstents deployed within the Palmaz stent. CONCLUSION: Stent collapse was observed in a significant number of Palmaz stents within 6 mo of placement in the carotid arteries. These observations should influence the choice of stents for the treatment of extracranial carotid disease.

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PubMed1997

Bailout and corrective use of Gianturco-Roubin flex stents after percutaneous transluminal coronary angioplasty: operator reports and angiographic core laboratory verification from the National Heart, Lung, and Blood Institute/New Approaches to Coronary Intervention Registry.

OBJECTIVES: We sought to determine the in-hospital clinical outcome and angiographic results of patients prospectively entered into the National Heart, Lung, and Blood Institute/New Approaches to Coronary Intervention (NHLBI/NACI) Registry who received Gianturco-Roubin stents as an unplanned new device. BACKGROUND: Between August 1990 and March 1994, nine centers implanted Gianturco-Roubin flex stents as an unplanned new device in the initial treatment of 350 patients (389 lesions) who were prospectively enrolled in the NHLBI/NACI Registry. METHODS: Patients undergoing implantation of the Gianturco-Roubin flex stent were prospectively entered into the Gianturco-Roubin stent portion of the NHLBI/NACI Registry. Only subjects receiving the Gianturco-Roubin stent as a new device in an unplanned fashion are included. RESULTS: The mean age of the patient group was 61.8 years, and the majority of the patients were men. A history of percutaneous transluminal coronary angioplasty (PTCA) was present in 35.4% of the group, and 16.9% had previous coronary artery bypass graft surgery. Unstable angina was present in 67.7%. Double- or triple-vessel coronary artery disease was present in 55.4%, and the average ejection fraction was 58%. The presence of thrombus was noted in 7.3%, and 7.2% had moderate to severe tortuosity of the lesion. The angiographic success rate was 92%. Individual clinical sites reported that 66.3% of the stents were placed after suboptimal PTCA, 20.3% for abrupt closure and 13.4% for some other technical PTCA failure. Major in-hospital events occurred in 9.7% of patients, including death in 1.7%, Q wave myocardial infarction in 3.1% and emergency bypass surgery in 6%. Abrupt closure of a stented segment occurred in 3.1% of patients at a mean of 3.9 days. Cerebrovascular accident occurred in 0.3%, and transfusion was required in 10.6%. Vascular events with surgical repair occurred in 8.6% of patients. CONCLUSIONS: Despite these complications, the use of this device for the treatment of a failed or suboptimal PTCA result remains promising given the adverse outcome of abrupt closure with conventional (nonstent) treatment.

Angioplasty, Balloon, Coronary↗
PubMed1997

Carotid artery stents: early and intermediate follow-up with Doppler US.

PURPOSE: To determine whether ultrasound (US) is a sensitive follow-up method after placement of a carotid artery stent for the detection of significant stenosis, occlusion, and other complications at early and intermediate follow-up. MATERIALS AND METHODS: Doppler US examinations were performed after stent placement in 170 carotid arteries in 119 patients with angiographic correlation. Prospective diagnostic US criteria for stenosis were peak-systolic velocity greater than 1.25 m/sec, internal carotid artery (ICA) to common carotid artery (CCA) peak-systolic velocity ratio of greater than or equal to 3:1, and intrastent doubling of peak-systolic velocity. Retrospective criteria for stenosis were also applied: peak-systolic velocity greater than 1.7 m/sec, ICA end-diastolic velocity greater than 0.4 m/sec, ICA/CCA peak-systolic velocity ratio greater than 2.0, and ICA/CCA end-diastolic velocity ratio greater than 2.4. RESULTS: Eighty-seven immediate and 83 intermediate (average, 7.3 months) follow-up US examinations were performed. Two stent occlusions were detected. One or more prospective US criteria were abnormal in 26 arteries with a stent. One or more retrospective criteria were positive in 47 arteries. Angiography showed corresponding findings, with only one significant stenosis (63%) in the ICA stents. Moderate collapse of a CCA stent was depicted at US. CONCLUSION: Only one significant recurrent stenosis was detected, and no significant stenoses were missed at US. US successfully depicted carotid artery stent occlusion and a moderate stent collapse. Sensitivity in the detection of intrastent stenosis is promising. Further study to refine US criteria in a study with longer term follow-up is needed owing to the lack of significant recurrent stenosis in the intermediate follow-up group.

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PubMed1996

Comparison of aspirin alone versus aspirin plus ticlopidine after coronary artery stenting.

This prospective nonrandomized study was performed comparing aspirin alone (n = 46) versus aspirin and ticlopidine (p = 338) following native coronary artery stenting. There were significantly more stent thrombosis events in the aspirin-only group than in the aspirin and ticlopidine group (6.5% vs 0.9%, p = 0.02) and significantly more Q-wave myocardial infarctions and cardiac-related deaths in the aspirin-only group than in the aspirin and ticlopidine group (6.5% vs 0%, p = 0.002 and 4.4% vs 0.3% p = 0.02, respectively).

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PubMed1996

Carotid stent-supported angioplasty: a neurovascular intervention to prevent stroke.

Obstructive carotid artery disease is responsible for 60% of strokes in the United States and is the third major cause of death. Stent-supported carotid artery angioplasty has the potential to prevent stroke in thousands of patients and offers a number of potential advantages over surgical revascularization (carotid endarterectomy). Results of the prospective observational study at the University of Alabama at Birmingham indicate that carotid stent-supported angioplasty is safe and probably effective in reducing stroke in patients with high-risk cerebrovascular disease. Technical success was achieved in 99% of 146 procedures; 210 stents were placed in 152 vessels, with only 1 instance of stent thrombosis. The rate of major in-hospital complications was unexpectedly low-only 1 death and 2 major strokes. Seven patients suffered minor strokes, but only 2 were left with minor weakness. When compared with a projected complication rate of 6% had these patients undergone carotid endarterectomy, stenting resulted in fewer major events. At 6-month follow-up, 69 of 74 patients were evaluated by angiography or ultrasound, which detected 8 cases of stent deformation and a restenosis rate of < 5%. Because of these instances of stent deformation, use of the Palmaz (biliary) stent was discontinued. Although 1 patient had a transient ischemic attack, no strokes occurred during follow-up. To date, carotid stenting is an investigational procedure. Cardiovascular interventionalists, industry, and the FDA are encouraged to validate this approach through clinical testing. However, improvements in technique, devices, and adjunctive therapies are needed before the method can be tested in randomized trials.

Adult↗
PubMed1996

A cost analysis of coronary stenting without anticoagulation versus stenting with anticoagulation using warfarin.

A case-controlled study was performed comparing hospitalization costs and length of hospital stay in a group of patients managed with antiplatelet therapy only, versus a group treated with anticoagulation using warfarin after coronary artery stenting. The patients managed with antiplatelet therapy alone had significantly reduced total hospitalization costs and a significantly reduced average hospital stay than patients managed with anticoagulation.

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PubMed1996

Utilization of the coronary balloon-expandable coil stent without anticoagulation or intravascular ultrasound.

BACKGROUND: The balloon-expandable coil stent has been proved effective in the management of acute and threatened closure after coronary balloon angioplasty and has been shown to reduce restenosis in patients with suboptimal results after coronary balloon angioplasty. Coronary artery stenting has been limited by the occurrence of stent thrombosis and comorbidity related to anticoagulation. This study was undertaken to determine whether anticoagulation may be removed from poststenting protocols, thus reducing comorbidity without increasing stent thrombosis. METHODS AND RESULTS: Between September 1994 and May 1995, 369 patients received balloon-expandable coil stents in native coronary arteries at our institution. Of these patients, 216 were selected for a protocol of aspirin and ticlopidine (for 1 month) without anticoagulation. Eligibility for this protocol followed satisfaction of certain procedural and angiographic criteria. These criteria included adequate coverage of intimal dissections, absence of residual filling defects, and normal (TIMI grade 3) flow in the stented vessel after high-pressure balloon inflations. Intravascular ultrasound was not used to guide stent deployment. The stenting procedure was planned in 37% of patients and unplanned in 63% of patients, including 25 (12%) for acute or threatened closure. During the 30-day follow-up period, stent thrombosis occurred in 2 patients (0.9%), there was 1 death (0.5%), and 2 patients (0.9%) underwent coronary bypass surgery. Vascular access-site complications occurred in 4 patients (1.9%), and bleeding that required blood transfusion occurred in 4 patients (1.9%). CONCLUSIONS: Patients who receive the coronary balloon-expandable coil stent with optimal angiographic results without intravascular ultrasound guidance can be managed safely with a combination of aspirin and ticlopidine without anticoagulation.

Adult↗
PubMed1996

Intravascular ultrasound-guided transluminal extraction atherectomy for restenosis after Gianturco-Roubin coronary stent implantation.

Two patients with restenosis following implantation of the Gianturco-Roubin stent were successfully treated with the transluminal extraction atherectomy device, with the assistance of intravascular ultrasound guidance and adjunctive balloon angioplasty. The optimal management strategy of in-stent restenosis remains unclear, but the transluminal extraction atherectomy device may be an option for the management of restenosis within the Gianturco-Roubin stent.

Angioplasty, Balloon, Coronary↗
PubMed1996

Long-term intracoronary stent placement: arteriographic and histologic results after 7 years in a dog model.

Prosthetic intracoronary stenting has become an important adjunct to balloon angioplasty in the percutaneous treatment of coronary artery disease. However, there are few reports of the long-term histologic consequences of stenting in the world literature. We report the arteriographic, histologic, and ultrastructural examination of a flexible tantalum wire coil stent implanted in the coronary artery of a dog for 7 years. The vessel was arteriographically patent without evidence of either stenosis or ectasia. The stent had been incorporated into the arterial wall, and was covered with a neointima of approximately 100 microns maximum thickness. There was necrosis of the tunica media adjacent to the stent but the inflammatory response was restricted to occasional macrophages in the neointima of the immediate vicinity of the stent wire. The endothelial cell layer was normal in its morphologic appearance. In summary, the flexible tantalum wire coil stent was well tolerated by the host blood vessel and demonstrated acceptable biocompatibility for the 7-year duration of its implantation in the normal dog coronary artery.

Animals↗
PubMed1996

Closure of an iatrogenic femoral artery pseudoaneurysm by transcutaneous coil embolization.

Pseudo-aneurysm following diagnostic or interventional procedures is a well-recognized complication. Ultrasound guided compression repair is routinely used to close an uncomplicated pseudo-aneurysm. We describe a patient with a femoral artery pseudo-aneurysm following iliac angioplasty and stenting in which ultrasound guided compression repair failed. Pseudoaneurysm was successfully closed by transcutaneous coil embolization technique.

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PubMed1996

Intracoronary stenting using slotted tubular stents with intravascular ultrasound and anticoagulation.

Intravascular ultrasound guidance has been suggested as a prerequisite before managing patients receiving slotted tubular stents without anticoagulation. The purpose of this prospective observational study was to determine if patients receiving this stent can be similarly managed following angiographic guided stent deployment without intravascular ultrasound assistance. A total of 137 patients receiving slotted tubular stents were selected to receive a protocol of aspirin 325 mg and ticlopidine 250 mg for 30 days following the satisfaction of certain angiographic criteria. These criteria were: adequate coverage of intimal dissections, absence of residual filling defects, and normal (TIMI III) flow in the stented vessel at the end of the procedure. The stenting procedure was planned in 68% of patients and unplanned in 32% of patients. During the 30 day clinical follow period there were no stent thrombosis events, no Q-wave myocardial infarctions, and no deaths. Non-Q-wave myocardial infarction occurred in 3 patients (2.2%), hemorrhage requiring blood transfusion in 3 patients (2.2%), and 1 patient (0.7%) developed a pseudo-aneurysm of the cannulated femoral artery. These data indicate that patients receiving slotted tubular stents with optimal angiographic results can be safely managed with the combination of aspirin and ticlopidine without anticoagulation or the need for intravascular ultrasound guidance.

Adult↗
PubMed1996

Platelet activation and restenosis after coronary stenting: flow cytometric detection of wound-induced platelet activation.

BACKGROUND: Platelet activation has been implicated in restenosis after percutaneous transluminal coronary angioplasty (PTCA), but previous studies may have been confounded by factors such as elastic recoil and arterial remodelling. Restenosis after coronary stenting is unlikely to be affected by these factors. METHODS: Forty-nine patients who had stenting for acute or impending closure after PTCA were included in the study. Patients with restenosis (> or = 50% stenosis by angiography) and without restenosis were selected using a case-control design. Restenosis was determined by the caliper method. Patients were tested for platelet activation 1-4 years after their procedure while taking their usual medications (including aspirin). Reliability testing was conducted with 11 healthy subjects. Platelet activation was measured in blood leaving a bleeding-time wound (wound-induced platelet activation), using flow cytometry. Blood was collected from the wound site 1 and 2 min after the incision. Monoclonal antibodies were used to test for activation of glycoprotein (GP) IIb/IIIa (PAC-1), GPIIb/IIIa ligand binding (anti-ligand-induced binding site 1: anti-LIBS-1), and P-selectin expression (AC1.2). RESULTS: Short-term intersample reliability was very good to excellent for anti-LIBS-1 and AC1.2 (intraclass correlation coefficients 0.79-0.96), but only fair for PAC-1. Patients with restenosis (n = 25) had greater activation in all measures than patients without restenosis (n = 24); the difference was significant for GPIIb/IIIa ligand binding at 1 min (P = 0.03). The correlation between GPIIb/IIIa ligand binding at 1 min and percent stenosis at follow-up was also significant (P = 0.03). Patients taking nitrates had lower activation; after eliminating these patients, GPIIb/IIIa ligand binding was greater among patients with restenosis at both 1 and 2 min (P = 0.04 for both). CONCLUSIONS: The results suggest that increased GPIIb/IIIa ligand binding may be associated with restenosis after coronary stenting. The results also suggest that the wound-induced platelet activation method is a reliable and valid measure of platelet activity.

Angioplasty, Balloon, Coronary↗
PubMed1996

Reduction of thrombus formation without inhibiting coagulation factors does not inhibit intimal hyperplasia after balloon injury in pig coronary arteries.

BACKGROUND: The proposed mechanisms of restenosis after coronary angioplasty include neointima formation, vessel wall remodeling and mural thrombus. Poloxamer 188 does not inhibit coagulation factors, but was shown to reduce mural thrombus formation in pig coronary arteries after intracoronary stenting in an acute study. This study was performed to examine whether this agent may reduce neointima formation. METHODS: Thirty domestic juvenile pigs of weight 20-30 kg were anesthetized. A left angiogram was performed via a femoral artery. Proximal left anterior descending and circumflex arteries were dilated three times with a 20-30% oversized coronary angioplasty balloon catheter. Fifteen animals were allocated randomly to receive intravenous infusions of poloxamer 188, starting 30 min before angioplasty and continuing for 24 h. The remaining 15 received intravenous 0.45% saline and served as controls. The animals were killed 2 weeks after the angioplasty. Histologic studies of the arteries were performed. The severity of the injury and the amount of thrombus material incorporated in the neointima were assessed by semiquantitative methods. RESULTS: There was no significant difference between injury scores in the two groups. Thrombus material in the neointima in the treatment group was significantly less than that in those of the control group (thrombus areas 0.013 +/- 0.004 compared with 0.029 +/- 0.006 mm2, P < 0.02), but there were no significant differences between the neointimal (0.60 +/- 0.08 and 0.60 +/- 0.13 mm2) and luminal (2.51 +/- 0.21 and 2.44 +/- 0.26 mm2) areas in treatment and control groups. CONCLUSION: Continuous 24 h intravenous infusion of poloxamer 188 after balloon injury in pig coronary arteries may reduce mural thrombus formation significantly, but did not reduce neointima formation.

Angioplasty, Balloon, Coronary↗
PubMed1996

Angioplasty and stenting for restenosis after carotid endarterectomy. Initial experience.

BACKGROUND AND PURPOSE: Endarterectomy for recurrent carotid stenosis after endarterectomy has a significantly higher complication rate than the original operation. Angioplasty and stenting may offer a useful alternative treatment for these patients. METHODS: Between September 1994 and April 1996, 22 patients had 25 carotid arteries treated with angioplasty and stenting for postendarterectomy restenosis. All patients had an independent neurological examination and National Institutes of Health Stroke Scale evaluation before and after the procedure. Patients were treated with aspirin and ticlopidine. All patients were requested to return at 6 months for follow-up angiography. The mean patient age was 69 +/- 7 years, and the mean elapsed time from endarterectomy was 73 +/- 69 months. Seventy-seven percent of the patients were symptomatic. RESULTS: Mean stenosis was reduced from 79 +/- 13% before the procedure to 1.8 +/- 3.6% after stenting. One patient had a minor stroke, for a complication rate of 4% per treated artery. In the eight patients who returned for 6-month angiography, mean stenosis was 19.4 +/- 4.4% and restenosis (> or = 50% stenosis) did not occur. CONCLUSIONS: In a small series, angioplasty and stenting appear to be safe and well tolerated for the treatment of postendarterectomy restenosis.

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