Joseph Salloum

Outcome of access site in patients treated with platelet glycoprotein IIb/IIIa inhibitors in the era of closure devices

The most consistent procedural predictor of vascular access site complications thus far has been the intensity and duration of anticoagulant therapy during and after percutaneous coronary interventions (PCI). Several devices have been developed to aid in the closure of the femoral arteriotomy. This report describes the clinical outcome of unsuccessful deployment of femoral closure devices in a cohort of 285 consecutive patients who underwent PCI and were treated with platelet glycoprotein (GP) IIb/IIIa inhibitors. Manual femoral artery compression was used in 123 patients, Perclose in 123 patients, and AngioSeal in 39 patients. Successful homeostasis was achieved in 98.4% of patients who received manual compression, in 91.9% of the Perclose‐sealed arteriotomy, and in 84.6% of patients who received the AngioSeal closure device (P = 0.004). The incidence of vascular complications after successful deployment was 9%. Patients not achieving hemostasis with closure device or 1° manual compression developed complications in the majority of cases (> 80%; P < 0.05). By multivariate analysis (with adjustment for baseline differences), the use of AngioSeal closure device was found to be an independent risk factors leading to primary deployment failure and all access site complications (OR 2.97; 95% CI 1.5–6.0; P = 0.006). In summary, failed hemostasis by artery closure devices in patients undergoing PCI who are treated with GP IIb/IIIa inhibitors is associated with significant vascular complications. AngioSeal may be associated with a higher failure rate, while manual compression and Perclose seem to be more effective with a lower complication rate. Cathet Cardiovasc Intervent 2003;58:1–5.

Effects of clopidogrel pretreatment before percutaneous coronary intervention in patients treated with glycoprotein IIb/IIIa inhibitors (abciximab or tirofiban)

T clinical efficacy and safety of clopidogrel pretreatment in addition to glycoprotein (GP) IIb/IIIa antagonists during percutaneous coronary intervention (PCI) is unknown. This study compares the in-hospital clinical outcome of patients who received clopidogrel pretreatment before PCI with that in patients who did not receive it as adjunctive antiplatelet therapy to GP IIb/IIIa antagonists. • • • Data were collected from the Memorial Hermann Heart Center Interventional Cardiology database. We examined a consecutive series of 299 patients undergoing PCI. All patients received GP IIb/IIIa inhibitor therapy in the form of abciximab or tirofiban. Use and type of GP IIb/IIIb antagonists was at the discretion of the operator. Abciximab was given as a bolus dose of 0.25 mg/kg body weight followed by continuous infusion of 10 g/min for 12 hours. Tirofiban was given as a loading dose of 0.4 g/kg/min for 30 minutes followed by a maintenance dose of 0.1 g/kg/min for 12 to 24 hours after the procedure. All patients were taking aspirin and received a heparin bolus to achieve an activated clotting time between 250 and 300 seconds. Patients presenting to the catheterization laboratory with a developing myocardial infarction (MI) for a primary or rescue angioplasty were excluded. Patients were divided into 2 groups: those who received clopidogrel pretreatment before PCI (starting within 5 days before PCI or a loading dose of 300 mg the morning of the day of the procedure at the discretion of the primary operator, group I), and those who received aspirin alone (group II) with clopidogrel (300 mg loading dose and 75 mg/day for 1 month) given after stent deployment. Therapy with clopidogrel (75 mg/day) was continued for 1 month in both groups if the stent was deployed during the procedure. Coronary angioplasty and intracoronary stent implantation were performed using standard percutaneous techniques. Balloon size was selected to match the reference vessel diameter obtained from on-line angiographic analysis (1.1:1 balloon/artery ratio). Different types of stents were used (excluding open coil type). After stent implantation, high-pressure balloon dilatation was performed for angiographic optimization. Intravascular ultrasonography–guided coronary stenting was not performed in most patients. Each operator relied on his own judgment or on other objective measurements, such as online quantitative coronary angiography, to assess PCI results. On completion of the procedure, patients were moved to a monitored unit and the arterial sheath was removed. Successful PCI was defined as final residual stenosis within the treated lesion of 20%, with achievement of Thrombolysis In Myocardial Infarction grade 3 flow, without in-lab occurrence of death, MI, or a complication requiring immediate coronary revascularization. A major adverse cardiac event was defined as any 1 of the following: (1) Q-wave or non–Q-wave MI, (2) need for urgent repeat target vessel revascularization, or (3) cardiovascular death that occurred during the period of hospitalization after the index coronary procedure. Postprocedural MI was defined as the occurrence of typical ischemic chest pain of 30 minutes duration with a creatine kinase elevation of 3 times the upper limit of normal with an associated increase in the MB fraction. There was no routine protocol for acquisition of postprocedure creatine kinase. All postprocedural cardiac enzymes were obtained for suspected recurrent myocardial ischemia, manifested by recurrent postprocedural chest pain, hemodynamic instability, or new electrocardiographic changes of ischemia. Urgent target vessel revascularization was defined as a repeat PCI or coronary artery bypass grafting of the index artery due to presumed recurrent ischemia manifested by recurrent angina, arrhythmias, or hemodynamic compromise. Adverse effects of therapy were recorded and compared between the 2 groups. These consist of major bleeding and thrombocytopenia. Major bleeding was defined as bleeding requiring transfusion of blood products or precipitating hemodynamic compromise. Intracerebral hemorrhage of any extent was considered a major adverse effect of therapy. Thrombocytopenia was defined as platelet count 100,000/mm. Chi-square and Fischer exact tests were used for analysis of categorical variables when appropriate, and Student t testing was used for analysis of continuous variables. Multivariate logistic regression analysis was performed to determine significance of variables related to an in-hospital major adverse cardiac From the Cardiology Division, University of Texas Medical School and Hermann Heart Center, Memorial Hermann Hospital, Houston, Texas. Dr. Rosales’ address is: Division of Cardiology, University of Texas Health Science Center-Houston, PO Box 20708, Houston, Texas 77225-0708. Manuscript received March 29, 2001; revised manuscript received and accepted May 30, 2001.

Combined cutting balloon angioplasty and intracoronary beta radiation for treatment of in‐stent restenosis: Clinical outcomes and effect of pullback radiation for long lesions

Intracoronary beta (β) radiation decreases the incidence of target lesion revascularization after percutaneous intervention (PCI) for in‐stent restenosis (ISR). Cutting balloon (CB) angioplasty may also be superior to other percutaneous techniques for the treatment of ISR. We sought to study the outcomes of patients with ISR who underwent both CB angioplasty and intracoronay β radiation and compare them to patients with ISR who underwent other PCI techniques without concomitant radiation. We also sought to evaluate the safety and efficacy of pullback intracoronary β radiation for the treatment of long ISR lesions. Between January 2001 and November 2001, 102 patients (mean age = 55 ± 13 years) with ISR underwent both CB angioplasty and intracoronay β radiation. β radiation was delivered using the Beta Cath (Novoste) 30 mm system, and pullback radiation was performed in 41 patients. A comparison group included a total of 393 patients with ISR who underwent other PCI techniques without concomitant intracoronary radiation therapy. Follow‐up was obtained in 99 patients (97%) in the CB angioplasty with intracoronary radiation group and 377 patients (96%) in the comparison group. At follow‐up, both target vessel revascularization (TVR) and major adverse cardiovascular events (MACE) occurred significantly less in the CB angioplasty with intracoronary radiation group than in the comparison group (7% vs. 18% for TVR, and 14% vs. 24% for MACE; P < 0.05 for both). In the pullback radiation group, TVR was performed in five patients (12%), and MACE occurred in eight patients (20%). A combination of CB angioplasty and intracoronay β radiation for ISR seems to yield low rates of subsequent target vessel revascularization and adverse cardiac events. In addition, pullback β radiation using the Beta Cath (Novoste) 30 mm system is safe and can be used to treat long ISR lesions effectively. Further randomized trials are needed to confirm these findings. Cathet Cardiovasc Intervent 2002;57:325–329.

Interatrial defect sizing by intracardiac and transesophageal echocardiography compared with fluoroscopic measurements in patients undergoing percutaneous transcatheter closure

The purpose of this study was to evaluate prospectively the feasibility and accuracy of using echocardiographic measurements by transesophageal and intracardiac echocardiography (TEE and ICE, respectively) for interatrial septal defect sizing during percutaneous transcatheter closure. Forty‐two patients underwent balloon sizing of interatrial septal defects using TEE in 21 of them and ICE in the other half. These measurements were correlated with quantitative fluoroscopic analysis and evaluated for bias and agreement between methods using a Bland‐Altman analysis. Echocardiographic measurements were obtained by ICE and TEE in all patients. An excellent correlation was found between TEE and quantitative fluoroscopy (r = 0.898; P < 0.001) and between ICE and quantitative fluoroscopy (r = 0.876; P < 0.001), with a significant agreement (P < 0.001) and minimal positive bias toward the echocardiographic measurements. Both TEE and ICE are excellent methods of interatrial defect sizing when compared with quantitative fluoroscopic measurements. Catheter Cardiovasc Interv 2004;62:415–420.

Percutaneous closure of patent foramen ovale guided by intracardiac echocardiography and performed through the transfemoral approach in the presence of previously placed inferior vena cava filters: A case series

We present three patients with cryptogenic stroke who underwent transcatheter closure of a patent foramen ovale. All patients have had history of deep venous thrombosis and pulmonary embolism with placement of inferior vena caval filters. The patients were not initially considered suitable candidates for the procedure because of risk of dislodgment of previously implanted inferior vena cava filter. Catheter Cardiovasc Interv 2004;63:242–246.

Renal Artery Compromise Treated Percutaneously in a Patient with Chronic Aortic Dissection: A Case Report

Organ malperfusion most commonly occurs in the acute stage of aortic dissection and is associated with a high mortality, but can occur with chronic dissection. We describe a case of a type 3 aortic dissection, which had a stenosed left renal artery originating from the false lumen and causing resistant hypertension. The left renal artery was successfully dilated and stented, with prompt resolution of the patients hypertension. Catheter Cardiovasc Interv 2004;61:445–449.