In Brief: Original Research

The following abstracts are reprinted with permission from the March 2003, April 2003 and May 2003 issues of the Journal of Invasive Cardiology. Taxol-Based Eluting Stents From Theory to Human Validation: Clinical and Intravascular Ultrasound Observations Shinjo Sonoda, MD, Yasuhiro Honda, MD, Toru Kataoka, MD, *Heidi N. Bonneau, RN, MS, Krishnankutty Sudhir, MD, PhD, Paul G. Yock, MD, **Gary S. Mintz, MD, Peter J. Fitzgerald, MD, PhD From the Division of Cardiovascular Medicine, Stanford University Medical Center, Stanford, California, *Highlands Consulting, Inc., San Jose, California, and **Cardiovascular Research Institute, Washington Hospital Center, Washington D.C. ABSTRACT: Treatment with antiproliferative drugs via coated stents appears to be a promising approach to both mechanically remodel target lesions and biologically reduce neointimal hyperplasia. Drug-eluting stents can maximize local drug effects and minimize the potential for systemic toxic effects. The purpose of this review is to describe the effects of a lipophilic microtubular inhibitor, paclitaxel, a strong antiproliferative agent under clinical investigation, and to define the vascular response to taxol-based eluting stents by intravascular ultrasound. J INVAS CARDIOL 2003;15:109-114 Direct Stenting May Limit Myocardial Injury During Percutaneous Coronary Intervention Thuraia Nageh, BSc, MD, Martyn R. Thomas, MD, Roy A. Sherwood, DPhil, Beverley M. Harris, MSc, David E. Jewitt, BSc, MD, Ray J. Wainwright, BSc, MD From King’s College Hospital, Denmark Hill, London, England, United Kingdom. ABSTRACT: Background. Direct coronary stenting has been shown to be safe and feasible, with a demonstrable reduction in cost, procedural time and radiation exposure. Direct stenting may limit distal embolization of atherosclerotic plaque and consequently reduce myocardial cell injury following percutaneous coronary intervention, which may have important prognostic implications. Methods and Results.We assessed cardiac troponin I (cTnI) release in the 24 hours following direct coronary stenting (DS) as compared to stenting with balloon predilatation (PD) in a total of 311 patients and 440 vessels/lesions (vessel to lesion ratio = 1:1) (DS: n = 107 patients and 149 vessels/lesions; PD: n = 204 patients and 291 vessels/lesions). The 2 groups were well matched except for a greater proportion of diabetic patients in the PD group (21%) compared to the DS group (11%) (p 0.2 µg/L in 11 patients (10%) in the DS group and in 53 patients (26%) in the PD group (X2 = 58.6; p Conclusion. Direct stenting without balloon predilatation is associated with lower post-procedural cTnI concentrations and lower incidence of major adverse events compared to traditional stenting with predilatation. J INVAS CARDIOL 2003;15:115-118 Practice and Outcomes of Percutaneous Coronary Intervention in the Community Before Drug-Eluting Stents: A Report from the HCA Database Aaron D. Kugelmass, MD, *David J. Cohen, MD, MPH, Salvatore L. Battaglia, BS, **Lynn G. Tarkington, RN, Edmund R. Becker, PhD, §Steven D. Culler, PhD From the Cardiovascular Division, Henry Ford Hospital, Detroit Michigan, *the Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts, **HCA, Inc., Nashville, Tennessee, Medical City Dallas Hospital, Dallas, Texas, ¡Cardiac Data Solutions, Inc., Indianapolis, Indiana, and Rollins School of Public Health, Emory University, Atlanta, Georgia. ABSTRACT: Background. Percutaneous coronary intervention (PCI) using balloon angioplasty and/or intracoronary stents has increasingly become the treatment choice for myocardial revascularization. While acute clinical outcomes of the community-based PCI procedures have been examined, much less is known about long-term revascularization rates, disease progression and other adverse outcomes. Methods and Results. Information on patient demographics, coronary risk factors, lesion characteristics, procedures and outcomes were derived from an HCA, Inc. database on all patients undergoing a PCI procedure in one of four community cardiac catheterization laboratories. A total of 3,192 consecutive patients were enrolled from July 1, 1999 through September 30, 2000. Analysis was limited to those patients undergoing PCI of native vessels with stents or conventional balloon angioplasty; target lesions in bypass grafts or those treated with atherectomy were excluded. Approximately one-third of enrolled patients were surveyed concerning their utilization of cardiovascular services 1 year following their initial procedure. The 1-year target lesion revascularization (TLR) was 9.9% while target vessel revascularization was 13.5%. Overall, 27.6% of patients underwent repeat revascularization within 1 year; 24.7% underwent at least 1 additional PCI and 5.6% underwent coronary artery bypass graft surgery. A total of 4.5% of patients reported an interval acute myocardial infarction with a major adverse cardiac event rate of 30.3% at 1 year. Conclusion. While clinically significant restenosis remains a problem for 10-15% of patients undergoing PCI, progression of coronary artery disease elsewhere appears to be an equally powerful driver in the need for recurrent revascularization. This analysis of contemporary PCI practice prior to drug-eluting stent utilization suggests that while these novel devices will likely reduce the incidence of TLR, many patients with coronary artery disease will still require additional revascularization for disease progression. J INVAS CARDIOL 2003;15:121-127 A Randomized, Multicenter Trial Comparing a New, Low-Pressure Stent Versus a Conventional Stent: Primary Results from the CONSERVE Trial Sorin J. Brener, MD, *Mark G. Midei, MD, E. Dean Nukta, MD, Dean J. Kereiakes, MD, ¡David G. Rizik, MD, Donel Murphy, RN, Danielle Brennan, MS, David J. Moliterno, MD, Eric J. Topol, MD, for the Comparison of New Stents for Equivalency of Reduction in Vascular Events (CONSERVE) Investigators From Cleveland Clinic Foundation, Cleveland, Ohio, *St. Joseph’s Hospital, Towson, Maryland, Fairview General Hospital, Cleveland, Ohio, Christ Hospital, Cincinnati, Ohio, and ¡Shea Hospital, Scottsdale, Arizona. ABSTRACT: Because it is uncertain whether high-pressure stent deployment may contribute to more exuberant neointimal proliferation, a new stent, the LP, was constructed to allow full expansion at Early and Late Reactions Following the Use of Iopamidol 340, Iomeprol 350 and Iodixanol 320 in Cardiac Catheterization A.G.C. Sutton, *P. Finn, P.G. Campbell, D.J.A. Price, J.A. Hall, M.J. Stewart, A. Davies, N.J. Linker, A.A. Harcombe, M.A. de Belder From the Cardiothoracic Division, the James Cook University Hospital, Middlesbrough, England, and *the Postgraduate Institute, School of Health and Social Care, University of Teesside, Middlesbrough, England, United Kingdom. ABSTRACT: Goal. To investigate the incidence of early ( 24 hours to 7 days) reactions to 3 contrast agents commonly used in cardiac catheterization. Methods and Results. A total of 2,108 patients undergoing cardiac catheterization in a Regional Cardiothoracic Unit were randomly assigned to receive 1 of 3 commonly used contrast agents in a prospective, double-blind study. The contrast agents were iopamidol 340 (Niopam®), a nonionic monomer; iomeprol 350 (Iomeron®), a nonionic dimer; and iodixanol 320 (Visipaque®), a nonionic dimer. The main outcome measures were the incidence of early (Conclusion. The incidence of early adverse reactions is similar with these 3 contrast agents. However, late skin reactions are significantly more common with iodixanol 320 (Visipaque®) than with the other 2 agents. Although such reactions were rarely troublesome, patients should be advised accordingly. J INVAS CARDIOL 2003;15:133-138 A Technique for Type 4a Coronary Bifurcation Lesions: Initial Results and 6-Month Clinical Evaluation Petros S. Dardas, MD, Dimitris D. Tsikaderis, MD, Nick E. Mezilis, MD, Giannis Styliadis, MD From the Thessaloniki Heart Institute, St. Luke’s Hospital, Cardiac Catheterization Department, Thessaloniki, Greece. ABSTRACT: In routine practice, lesions in coronary bifurcations are frequent. This relatively high frequency may be underestimated due to the presence of false bifurcation lesions (lesions of the main branch without significant lesion of the sidebranch), which may become true bifurcation lesions after stenting due to axial plaque redistribution. In this report, we describe our initial experience with a new technique for the treatment of type 4a bifurcation lesions (main branch ostial lesion stenosis of the main vessel immediately after the bifurcation, not involving the sidebranch) using a new technique for primary stenting of the main vessel with simultaneous kissing balloon of the sidebranch in an effort to avoid the snowplough effect. J INVAS CARDIOL 2003;15:180-183 Use of Platelet Glycoprotein IIb/IIIa Inhibitors and Spontaneous Pulmonary Hemorrhage Arshad Ali, MBBS, MRCP, Mustafa Hashem, MD, Howard S. Rosman, MD, Ghassan Kazmouz, MD, Julius M. Gardin, MD, Theodore L. Schrieber, MD From the Division of Cardiology, St. John Hospital & Medical Center, Detroit, Michigan. ABSTRACT: Background. The use of platelet glycoprotein (GP) IIb/IIIa inhibitors in patients undergoing percutaneous coronary intervention has resulted in an impressive reduction in adverse events. Pulmonary hemorrhage is a rare but potentially lethal complication of antithrombotic and antiplatelet therapy. We analyzed the incidence of spontaneous pulmonary hemorrhage following the use of platelet GP IIb/IIIa inhibitors. Methods. The medical records of 1,020 consecutive patients who received GP IIb/IIIa inhibitors and underwent PCI at our institution between August 1997 and December 1999 were reviewed. Results. Diffuse pulmonary hemorrhage developed in 7 patients (0.68%), two of whom died. Five of 7 patients with pulmonary hemorrhage had activated clotting times > 250 seconds during the procedure. Activated partial thromboplastin time measured at the time of pulmonary hemorrhage was elevated in all patients (mean, 85 seconds; range, 69-95 seconds). All patients had history of congestive heart failure and had elevated pulmonary capillary wedge pressure and/or left ventricular end-diastolic pressure at the time of the index procedure. Six patients also had evidence of baseline radiographic abnormalities. Conclusion. Diffuse pulmonary hemorrhage is a potentially disastrous complication of GP Ilb/Illa antagonists. No specific predictors can be identified, but evidence of pulmonary congestion, baseline pulmonary abnormalities and use of higher heparin dosages may predispose patients to this serious complication. J INVAS CARDIOL 2003;15:186-188 Arterial Wall Temperature Following Coronary Stent Implantation in Pigs: The Role of Post-Stent Inflammation Leonidas Diamantopoulos, MD, PhD, Yanming Huang, MD, Xiaosun Liu, MD, Shenggiao Li, MD, Walter Desmet, MD, PhD, Frans Van de Werf, MD, PhD, Ivan De Scheerder, MD, PhD From the Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium. ABSTRACT: Background. The purpose of this study was to investigate in vivo the arterial wall temperature after coronary stent implantation in pigs. Methods. We performed cardiac catheterization in 20 pigs with normal coronary arteries. Arterial wall temperature was studied with a thermography system that uses a 4-thermistor sensor tip. A segment was selected in the proximal right coronary artery. Temperature was mapped in this segment by means of a continuous catheter pullback. A stent was then implanted in the middle of this area, and the temperature scan was repeated. Pigs were randomized in two groups (10 + 10 pigs) for arterial temperature scanning: group A to be re-scanned after 5 days and then sacrificed, and group B to be re-scanned after 8 days and then sacrificed. Results. The temperature of the arterial wall before stent implantation was equal to the adjacent areas. Immediately after stent implantation, the stented area had lower temperature than the adjacent areas (p Conclusion. Stent implantation results in an immediate temperature decrease at the stented arterial segment, followed by a significant temperature increase around day 5 after stent implantation. These findings can be correlated with the peri-strut inflammation that follows the stent implantation. J INVAS CARDIOL 2003;15:191-197 Superficial Femoral Artery Occlusion: Nitinol Stents Achieve Flow and Reduce the Need for Medications Better than Balloon Angioplasty Alone Leslie Cho, MD, *Marco Roffi, MD, Debabrata Mukherjee, MD, Deepak L. Bhatt, MD, §Christopher Bajzer, MD, Jay S. Yadav, MD From Loyola University Medical Center, Maywood, Illinois, *University of Hospital Zurich, Switzerland, University of Michigan Medical Center, Ann Arbor, Michigan, Cleveland Clinic Foundation, Cleveland, Ohio. ABSTRACT: Background. Nitinol slotted tube stents are of great potential benefit in superficial femoral artery (SFA) interventions due to their elastic properties. However, a paucity of data exists for their efficacy in total SFA occlusions. Methods. Using the Cleveland Clinic Foundation Peripheral Database, we identified 40 consecutive patients who underwent percutaneous revascularization for chronically occluded SFA and addressed the outcome stratifying for stent use. We evaluated the reduction in the pressure gradient across the lesion and the need for medication following revascularization. Results. Of the 40 patients, twenty-six underwent balloon angioplasty alone and 14 received nitinol slotted tube stents. Patients were well matched for age and cardiovascular risk factors. Similarly, there were no differences in baseline ankle brachial index (ABI) or claudication class between the groups. Compared to angioplasty alone, stenting was associated with a greater reduction in translesional pressure gradient (72 mmHg versus 32 mmHg; p = 0.002). In addition, patients treated with stents were less likely to require post-procedure adjunctive medical treatment (7.1% versus 42.6%; p = 0.03). Conclusion. In SFA occlusion, stenting results in greater reduction in translesional pressure gradient and reduced need for adjunctive medical treatment. J INVAS CARDIOL 2003;15:198-200 Severe Aortic Coarctation in Infants Less Than 3 Months: Successful Palliation by Balloon Angioplasty * P. Syamasundar Rao, MD, *Saadeh B. Jureidini, MD, *Ian C. Balfour, MD, *Gautam K. Singh, MD, *Su-chiung Chen, MD From the Division of Pediatric Cardiology, Department of Pediatrics, *Saint Louis University School of Medicine/Cardinal Glennon Children’s Hospital, St. Louis, Missouri and University of Texas-Houston Medical School/Memorial Hermann Children’s Hospital, Houston, Texas. ABSTRACT: The optimal management strategy of the neonate and young infant with native aortic coarctation (AC) is controversial. We reviewed our experience with balloon angioplasty (BA) in neonates and infants = 4 weeks along with control of presenting symptoms. We also compared the results of the transumbilical arterial (UA), transfemoral arterial (FA) and transfemoral venous anterograde (FVA) approaches we have used to accomplish BA. During a 6.5-year period ending June 2001, fifty-one neonates and infants Safety and Efficacy of Low-Dose Intravenous Enoxaparin and Glycoprotein IIb/IIIa Inhibitor Therapy During Percutaneous Coronary Intervention Louis Carnendran, MD, Robert Borkowski, MD, Bashar Markabawi, MD, Mark F. Warner, MD From the Harrisburg Medical Associates, Harrisonburg, Virginia. ABSTRACT: The use of intravenous enoxaparin, a glycoprotein (GP) IIb/IIIa inhibitor, during percutaneous coronary intervention (PCI) has been shown to be safe and to possibly reduce in-hospital and 30-day major adverse cardiac events (MACE). NICE-4, a recent PCI observational study, evaluated a reduced dose of intravenous (IV) enoxaparin (0.75 mg/kg) with abciximab. However, prior PCI studies evaluating IV enoxaparin have not used percutaneous closure devices. The purpose of this study was to observe the safety and efficacy of a lower dose of IV enoxaparin (0.5 mg/kg) in conjunction with any GP IIb/IIIa inhibitor. The Angio-Seal femoral closure device was also employed as part of the treatment strategy. We administered 0.5 mg/kg IV enoxaparin and a GP IIb/IIIa inhibitor to 75 eligible PCI patients. None received anticoagulation 24 hours prior to PCI; all received pre-procedural aspirin, post-procedural deployment of the Angio-Seal and clopidogrel therapy, and were discharged home within 36 hours. TIMI minor bleeding was 1.3%; there were no TIMI major bleeding events or major adverse cardiac events during in-hospital stay or at 30-day follow-up. Our small observational study shows that IV enoxaparin is safe and efficacious during PCI when given at a dose 33% lower than previously reported in conjunction with any GP IIb/IIIa inhibitor and Angio-Seal. However, large, randomized PCI trials are needed to confirm the clinical efficacy, safety and cost-effectiveness of lower doses of enoxaparin with GP IIb/IIIa inhibitors and vascular closure devices. J INVAS CARDIOL 2003;15:235-238 In-Hospital Complications of Peripheral Vascular Interventions Using Unfractionated Heparin as the Primary Anticoagulant Nicolas W. Shammas, MS, MD, *Jon H. Lemke, PhD, Eric J. Dippel, MD, *Dawn E. McKinney, MA, Vickie S. Takes, RN, Monica Youngblut, RN, Melodee Harris, RN, Catherine Harb, Matthew J. Kapalis, BSc, *Jane Holden, RN From the Genesis Heart Institute, Cardiovascular Medicine, PC, and *the Genesis Health System, Davenport, Iowa. ABSTRACT: Unfractionated heparin is the current antithrombotic of choice in peripheral vascular interventions. The rate of in-hospital major complications during peripheral angioplasty procedures (PTA) using heparin as the primary anticoagulant has not been well defined. In this single-center study, the charts of 213 consecutive PTA procedures in a 1-year period were reviewed. Of unstaged procedures, a total of 131 patients (57.3% males; mean age, 66.4 ± 12.1 years) met inclusion criteria. Forty-five patients (34.4%) had recent onset of claudication and 15 (11.5%) had ulceration. Thrombus was angiographically visualized in 16.7% of patients. Unfractionated heparin was administered at a mean of 4,672 ± 1,238 U (59.1 ± 20.0 U/kg) during the procedure. The highest activated clotting time (ACT) during the procedure was recorded in 114 patients. ACTs were 400 seconds in 29.0%, 29.0% and 42.1%, respectively. In-hospital clinical events occurred in 12 patients (9.2%) who met any one of the following endpoints: death (0.8%), limb loss (1.5%), major bleeding (4.6%), emergent need for repeat revascularization of the same vessel (7.6%), embolic stroke (0.0%) and vascular complications (1.5%). The best model associated with salvage revascularization included cigarette smoking within the past year, recent onset of claudication and PTA treatment below the knee. Increased dosages of heparin (U/kg) were associated with a trend toward higher rates of complications. A significant number of patients have in-hospital major complications following PTA procedures using unfractionated heparin as the primary anticoagulant. Current ongoing registries are evaluating the feasibility of direct thrombin inhibitors bivalirudin instead of heparin as a primary anticoagulant during PTA. J INVAS CARDIOL 2003;15:242-246 The Clinical Effectiveness of the Prostar® XL Suture-Mediated Percutaneous Vascular Closure Device for Achievement of Hemostasis in Patients Following Coronary Interventions: Results of the Perclose AcceleRated Ambulation and DISchargE (PARADISE) Trials Kenya Nasu, MD, *Etsuo Tsuchikane, MD, **Satoru Sumitsuji, MD, on behalf of the PARADISE Investigators From the Department of Internal Medicine, Hirai Hospital, Nara, Japan, *the Department of Cardiology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan and **the Department of Cardiovascular Medicine, Rinku General Hospital, Osaka, Japan. ABSTRACT: Background. The Prostar® XL is a hemostasis device designed to percutaneously close the arterial puncture site with two nonabsorbable sutures. The Early Discharge and Economical effectiveness study for New hemostasis device (EDEN) trial, which was performed in Japan, showed that the Prostar® XL device shortened time to hemostasis, time to ambulation and the average length of hospital stay, and decreased local vascular complications. However, the ooze of blood from the puncture site incision requires relatively longer time to ambulation. Objectives. The Perclose AcceleRated Ambulation and DISchargE (PARADISE) trial was performed to assess the effectiveness of the Prostar® XL device on patient comfort, shortened time to ambulation and discharge from hospital by minimizing the oozing problem. Methods.This multicenter, non-randomized registry was designed to compare times to hemostasis, ambulation and discharge, as well as the incidence of peripheral vascular complications in Prostar® XL patients with the conventional manual compression group in the EDEN trial. Hydrochloride lidocaine containing 1% epinephrine was used as local anesthesia to reduce blood oozing. Results. Between September 1999 and March 2000, a total of 109 patients were enrolled in this study. The closure device was successfully placed in 108 of 109 attempts. Time to hemostasis was significantly less than with the conventional manual compression group in the EDEN trial. Times to ambulation and discharge were significantly less than with the Prostar® XL and conventional manual compression groups in the EDEN trial. Conclusion. We conclude that the Prostar® XL device plus hydrochloride lidocaine containing 1% epinephrine as local anesthesia appears to be a safe and effective method to achieve hemostasis, and to improve times to ambulation and discharge after interventional procedures. J INVAS CARDIOL 2003;15:251-254 Simultaneous Multisite Endocardial Mapping of Sustained and Non-Sustained Atrial Fibrillation in Humans Martin R. Karch, MD, Gjin Ndrepepa, MD, Bernhard Zrenner, MD, Christoph Saur, MD, Michael A.E. Schneider, Albert Schumig, MD, Claus Schmitt, MD From the Deutsches Herzzentrum Munchen und 1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universita t Munuchen, Munich, Germany. ABSTRACT: The aim of this study was to investigate the differences between sustained and non-sustained forms of human atrial fibrillation (AF) using multielectrode endocardial recordings. Methods. Sixty-four pole basket catheters were deployed in the right atrium (RA) of 3 groups of patients: 1) patients with persistent AF (> 48 hours); 2) induced sustained AF (> 15 minutes); and 3) induced non-sustained AF (

NULL