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Biomedical subjects

A Giambartolomei

Publications and source records attributed to A Giambartolomei.

At least 19 recordsLinked to original sources
PubMed2001

Final results of a randomized trial comparing the NIR stent to the Palmaz-Schatz stent for narrowings in native coronary arteries.

The NIR stent is a novel second generation tubular stent that was designed to overcome some of the limitations of the earlier Palmaz-Schatz (PS) stent design. The NIR Vascular Advanced North American (NIRVANA) trial randomized 849 patients with single coronary lesions to treatment with the NIR stent or the PS stent. The study was an "equivalency" trial, designed to demonstrate that the NIR stent was not inferior to (i.e., equivalent or better than) the PS stent, for the primary end point of target vessel failure (defined as death, myocardial infarction, or target vessel revascularization) by 9 months. Successful stent delivery was achieved in 100% versus 98.8%, respectively, with a slightly lower postprocedural diameter stenosis (7% vs. 9%, p = 0.04) after NIR and PS stent placement, respectively. Major adverse cardiac events (death, myocardial infarction, repeat target lesion revascularization) were not different at 30 days (4.3% vs. 4.4%). The primary end point of target vessel failure at 9 months was seen in 16.0% of NIR versus 17.2% of PS patients, with the NIR proving to be equal or superior to the PS stent (p <0.001 by test for equivalency). Angiographic restudy in 71% of a prespecified cohort showed no significant difference in restenosis (19.3% vs 22.4%). Thus, the NIR stent showed excellent deliverability with slightly better acute angiographic results and equivalent or better 9-month target vessel failure rate when compared with the PS stent.

Aged↗
PubMed2001

Safety and efficacy of repeat transradial access for cardiac catheterization procedures.

To determine the safety and efficacy of repeat transradial cardiac catheterization, 1,362 consecutive transradial procedures were examined. Repeat transradial procedures were identified (group I, n = 73) and compared with index procedures (group II, n = 1,289). Baseline patient characteristics, procedure success rates (100% vs. 97.9%; P = NS), complication rates (0% vs. 0.08%; P = NS), and procedure times (23.9 +/- 27.3 min vs. 18.2 +/- 14.7 min; P = NS) were similar between groups. This study suggests that repeat transradial catheterization procedures can be performed safely and successfully in appropriately selected patients.

Aged↗
PubMed2001

Adjunctive therapies in the cath lab. Use of combination glycoprotein IIb/IIIa inhibitor and direct thrombin inhibitor drugs to support percutaneous coronary stent placement in a patient with renal insufficiency and heparin-induced thrombocytopenia.

An 81-year-old woman with a history of prior coronary artery bypass surgery, heparin-induced thrombocytopenia with "white clot" syndrome, and renal insufficiency presented with unstable angina. She was referred for cardiac catheterization. Complex percutaneous revascularization of the native circumflex coronary artery was performed using stents. A combination of tirofiban and lepirudin was used with dosing adjusted for renal insufficiency. The hospital course was uncomplicated and the patient was discharged on the fourth hospital day. This is only the second report of the combination use of direct thrombin inhibitor and glycoprotein IIb/IIIa receptor inhibitor.

Aged↗
PubMed2000

Transradial cardiac catheterization in elderly patients.

The safety and efficacy of transradial cardiac catheterization in elderly patients is unknown. This study examines procedure success rates for transradial catheterization in appropriately selected patients < 70 (n = 195) and >/= 70 (n = 83) years old. Elderly patients were less likely to be selected for the transradial approach (46% vs. 61%; P = 0.05). Although patients >/= 70 years old were more often female (39.7% vs. 24.1%; P = 0.008) and had a smaller body surface area (1.89 +/- 0.18 vs. 2.01 +/- 0.24 m2; P = 0. 001), procedure success rates did not differ (95.1% vs. 94.8%; P = NS). Procedure-related variables including procedure time (15.4 +/- 12.6 vs. 16.1 +/- 11.6 min; P = NS), amount of radiographic contrast (90.1 +/- 31.9 vs. 86.4 +/- 29.8 cc; P = NS), and number of catheters used (1.5 +/- 0.9 vs. 1.5 +/- 0.7; P = NS) were similar between groups. We conclude that transradial catheterization can be safely and effectively performed in selected elderly patients. Cathet. Cardiovasc. Intervent. 51:287-290, 2000.

Adult↗
PubMed1999

Coronary angioplasty with or without stent implantation for acute myocardial infarction. Stent Primary Angioplasty in Myocardial Infarction Study Group.

BACKGROUND: Coronary-stent implantation is frequently performed for treatment of acute myocardial infarction. However, few studies have compared stent implantation with primary angioplasty alone. METHODS: We designed a multicenter study to compare primary angioplasty with angioplasty accompanied by implantation of a heparin-coated Palmaz-Schatz stent. Patients with acute myocardial infarction underwent emergency catheterization and angioplasty. Those with vessels suitable for stenting were randomly assigned to undergo angioplasty with stenting (452 patients) or angioplasty alone (448 patients). RESULTS: The mean (+/-SD) minimal luminal diameter was larger after stenting than after angioplasty alone (2.56+/-0.44 mm vs. 2.12+/-0.45 mm, P<0.001), although fewer patients assigned to stenting had grade 3 blood flow (according to the classification of the Thrombolysis in Myocardial Infarction trial) (89.4 percent, vs. 92.7 percent in the angioplasty group; P=0.10). After six months, fewer patients in the stent group than in the angioplasty group had angina (11.3 percent vs. 16.9 percent, P=0.02) or needed target-vessel revascularization because of ischemia (7.7 percent vs. 17.0 percent, P<0.001). In addition, the combined primary end point of death, reinfarction, disabling stroke, or target-vessel revascularization because of ischemia occurred in fewer patients in the stent group than in the angioplasty group (12.6 percent vs. 20.1 percent, P<0.01). The decrease in the combined end point was due entirely to the decreased need for target-vessel revascularization. The six-month mortality rates were 4.2 percent in the stent group and 2.7 percent in the angioplasty group (P=0.27). Angiographic follow-up at 6.5 months demonstrated a lower incidence of restenosis in the stent group than in the angioplasty group (20.3 percent vs. 33.5 percent, P<0.001). CONCLUSIONS: In patients with acute myocardial infarction, routine implantation of a stent has clinical benefits beyond those of primary coronary angioplasty alone.

Angioplasty, Balloon, Coronary↗
PubMed1999

An unusual complication during deployment of a Multi-Link stent.

The use of intracoronary stents has greatly impacted on the practice of interventional cardiology. Complications due to equipment failure during deployment of stents are rare but potentially serious. We report a case of a malfunctioning Multi-Link delivery system and the successful treatment of the resulting complications.

Coronary Angiography↗
PubMed1999

Myocardial ischemia resulting from spontaneous dissection in a patient with massive bilateral sinus of valsalva aneurysms.

We describe a patient with large sinus of Valsalva aneurysms involving both the left and right coronary sinuses. Spontaneous dissection of the left coronary artery occurred, causing unstable angina, a complication heretofore not associated with this disease. Successful surgical reconstruction of the aortic root, aortic valve replacement, and coronary bypass grafting were performed. Pathology revealed cystic medial necrosis.

Aorta↗
PubMed1999

Transradial cardiac catheterization in patients with prior brachial artery cutdown.

The safety and efficacy of transradial cardiac catheterization in patients with prior ipsilateral brachial cutdown is not known. Using standard techniques we performed transradial catheterization in 278 consecutive patients, of which 63 had prior brachial cutdown. All patients had a strongly palpable radial pulse and a negative Allen's test. Although patients with prior cutdown were older and had a higher incidence of hypertension and prior coronary artery bypass surgery, there was no significant difference in success rates for transradial catheterization (93.6% vs. 95.3%; P = NS). There were no periprocedural complications. Brachial artery occlusion was responsible for only two unsuccessful catheterization attempts. We conclude that, with careful preprocedural screening, ipsilateral transradial cardiac catheterization can be successfully performed in a majority of patients with prior brachial cutdown.

Brachial Artery↗
PubMed1999

Successful treatment of a saphenous vein graft perforation with an autologous vein-covered stent.

A 52-year-old man with a history of prior coronary bypass surgery suffered recurrent angina and underwent percutaneous placement of a stent within the midportion of the saphenous vein graft to the marginal branch of the left circumflex coronary artery, which was complicated by a significant perforation. The perforation was successfully closed using an NIR stent covered with a segment of autologous antecubital vein. Subsequent surgical exploration confirmed successful closure of the perforation. Cathet. Cardiovasc. Intervent. 48:382-386, 1999.

Angioplasty, Balloon, Coronary↗
PubMed1999

Acute and nine-month clinical outcomes after "suboptimal" coronary stenting: results from the STent Anti-thrombotic Regimen Study (STARS) registry.

OBJECTIVES: This registry collected the 30-day and 9-month clinical outcomes of patients whose coronary stent implantation was suboptimal, and compared them with the cohort of patients with "optimal" stenting in the randomized portion of the STent Anti-thrombotic Regimen Study (STARS) trial. BACKGROUND: Although "optimal" stenting combined with an aspirin and ticlopidine regimen carries a low (0.5%) incidence of subacute stent thrombosis, only limited data are available for patients in whom stents are deployed suboptimally. METHODS: In the STARS, 312 (15.9%) of 1,965 patients enrolled were excluded from participation in the randomized trial based on a perceived "suboptimal" result of coronary stenting. Of these, 265 patients met prespecified criteria for suboptimal stenting, and were followed in a parallel registry, which was compared with the randomized STARS optimal stenting cohort. The primary end point was a 30-day composite of death, emergent target lesion revascularization, angiographic thrombosis of the target vessel without revascularization and nonfatal myocardial infarction (MI) unrelated to direct procedural complications. RESULTS: Registry patients had a similar frequency of the primary end point compared with the overall randomized cohort (3.0% vs. 2.2%), with this end point correlating to use of multiple stents, smaller final lumen diameter and absence of ticlopidine from the poststent regimen. Overall 30-day mortality (1.1% vs. 0.06%, p = 0.009) and periprocedural non-Q wave MI (8.7% vs. 4.2%, p = 0.003) were more frequent in registry patients, and appeared to be related to acute procedural complications. Clinical restenosis was significantly higher for registry patients (26.8% vs. 16.0%, p = 0.001), relating to greater prevalence of independent predictors such as smaller final lumen diameter and multiple stent use. CONCLUSIONS: In the STARS registry, the inability to perform optimal stenting correlated with smaller final lumen diameter and longer stent length. With ticlopidine-containing regimens, the acute clinical results of "suboptimal" stent deployment are clinically acceptable, although they are not quite as good as those of optimal stenting using similar drug therapy.

Acute Disease↗
PubMed1998

A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent Anticoagulation Restenosis Study Investigators.

BACKGROUND: Antithrombotic drugs are used after coronary-artery stenting to prevent stent thrombosis. We compared the efficacy and safety of three antithrombotic-drug regimens - aspirin alone, aspirin and warfarin, and aspirin and ticlopidine - after coronary stenting. METHODS: Of 1965 patients who underwent coronary stenting at 50 centers, 1653 (84.1 percent) met angiographic criteria for successful placement of the stent and were randomly assigned to one of three regimens: aspirin alone (557 patients), aspirin and warfarin (550 patients), or aspirin and ticlopidine (546 patients). All clinical events reflecting stent thrombosis were included in the prespecified primary end point: death, revascularization of the target lesion, angiographically evident thrombosis, or myocardial infarction within 30 days. RESULTS: The primary end point was observed in 38 patients: 20 (3.6 percent) assigned to receive aspirin alone, 15 (2.7 percent) assigned to receive aspirin and warfarin, and 3 (0.5 percent) assigned to receive aspirin and ticlopidine (P=0.001 for the comparison of all three groups). Hemorrhagic complications occurred in 10 patients (1.8 percent) who received aspirin alone, 34 (6.2 percent) who received aspirin and warfarin, and 30 (5.5 percent) who received aspirin and ticlopidine (P<0.001 for the comparison of all three groups); the incidence of vascular surgical complications was 0.4 percent (2 patients), 2.0 percent (11 patients), and 2.0 percent (11 patients), respectively (P=0.01). There were no significant differences in the incidence of neutropenia or thrombocytopenia (overall incidence, 0.3 percent) among the three treatment groups. CONCLUSIONS: As compared with aspirin alone and a combination of aspirin and warfarin, treatment with aspirin and ticlopidine resulted in a lower rate of stent thrombosis, although there were more hemorrhagic complications than with aspirin alone. After coronary stenting, aspirin and ticlopidine should be considered for the prevention of the serious complication of stent thrombosis.

Aged↗
PubMed1994

Peripheral vascular complications of coronary angioplasty by the femoral and brachial techniques.

In order to monitor the incidence and types of peripheral vascular complications in a single institution, we prospectively entered 1,579 coronary angioplasty cases into a computer data base during the years 1991 and 1992. Various periprocedural risk factors were analyzed. The patients were followed closely to identify complications that occurred outside the laboratory or after discharge from the hospital. Peripheral vascular complications occurred in 37 patients (2.37%) and included hematoma 20 (1.27%), retroperitoneal bleeding 7 (.44%), false aneurysm 6 (.38%), occlusion 1 (.06%), infection 2 (.13%), and cholesterol emboli 1 (.06%). Risk factors for complications by multivariate analysis were older age, female gender, and clinical evidence of peripheral vascular disease. Other factors potentially related to vascular trauma or bleeding tendency that were not risk factors in this series were clinical presentation, use of heparin or thrombolytic agents, blood clotting parameters, and arterial sheath size. There was no significant difference between the femoral and brachial approaches in frequency of complications (2.5% vs. 1.6%), but femoral complications tended to carry greater morbidity.

Aged↗
PubMed1991

Left atrial ball thrombus: review of clinical and echocardiographic manifestations with suggestions for management.

Left atrial ball thrombus is an infrequent clinical syndrome, which can have a catastrophic outcome but can be readily treated when recognized. It is usually a complication of long-standing rheumatic mitral stenosis. Symptomatic presentation is variable: fragmentation of the thrombus followed by peripheral embolization will produce ischemia or infarction of myocardium, brain, viscera, or extremities; random, intermittent, partial, or total occlusion of the mitral valve orifice may cause syncope, pulmonary congestion, and occasionally sudden death in other patients. Embolic and obstructive phenomena may also occur together. Cardiac physical findings usually suggest mitral stenosis; variability in the intensity of the diastolic rumble is common. Two-dimensional echocardiography is the gold standard for identifying ball thrombus. Cardiac catheterization provides assessment of coronary artery status when needed. The outcome of untreated ball thrombus is unlikely to be favorable. The results of anticoagulation and thrombolysis are unpredictable and potentially as harmful as no treatment at all. Current evidence although scant suggests that prompt surgical removal of the free thrombus, often in conjunction with mitral valve repair or replacement, is the appropriate therapeutic course in most patients.

Cardiology↗
PubMed1989

Massive left atrial thrombus: a possible paraneoplastic complication of breast carcinoma.

We describe a patient with long-standing rheumatic mitral valve disease, left atrial dilatation, and a precommissurotomy history of left atrial thrombus. Following operation she was maintained on daily aspirin as an antithrombotic measure. For 6 years she had no evidence, echocardiographically, of left atrial thrombus. She underwent surgery for apparently nonmetastatic breast cancer in early 1986. In May 1986 the left atrium was echocardiographically clear. At approximately the same time, recurrence was found at the suture line. In October 1987, two metastatic lung lesions and a very large left atrial mass were detected by computed tomography. The atrial mass was surgically removed and found to be a thrombus. There was a striking temporal correlation between dissemination of carcinoma and development of a massive atrial thrombus.

Atrial Fibrillation↗