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Interventional Cardiology (interventional + cardiology)
Selected AbstractsPediatric Interventional Cardiology in the United States is Dependent on the Off-label Use of Medical DevicesCONGENITAL HEART DISEASE, Issue 1 2010Jamie S. Sutherell MD ABSTRACT Objective., A substantial unmet medical device need exists in pediatric care. As a result, the off-label use of approved devices is routine in pediatric interventional cardiology, but the extent and nature of this practice has not been previously described. The purpose of this study, therefore, is to evaluate the prevalence and nature of off-label cardiac device use in an active pediatric interventional program in the United States. Study Design., This study is a retrospective review of all interventional cardiac procedures performed at our institution from July 1, 2005 to June 30, 2008. Diagnostic (noninterventional) catheterizations, myocardial biopsies, invasive electrophysiology studies, and studies involving investigational devices were excluded. Interventions performed were compared with the manufacturer's labeled indications for each device. Results., During this 3-year period, 473 patients (median age 4.1 years) underwent 595 transcatheter interventions. An approved device was utilized for an off-label application in 63% of patients, and in 50% of all interventions performed. The most frequent off-label procedures were stent implantations (99% off-label), balloon dilations (78% off-label), and coil embolizations (29% off-label). In contrast, the off-label use of septal and ductal occluders was relatively uncommon. Conclusions., In our routine (noninvestigational) practice of pediatric interventional cardiology, 63% of patients underwent procedures utilizing medical devices for off-label indications. These data underscore the need to enhance cardiac device review and approval processes in the United States to include pediatric applications. [source] Identifying women with severe angiographic coronary diseaseJOURNAL OF INTERNAL MEDICINE, Issue 1 2010C. Kreatsoulas Abstract., Kreatsoulas C, Natarajan MK, Khatun R, Velianou JL, Anand SS (McMaster University; CARING Network, McMaster University; Population Health Research Institute, McMaster University and Hamilton Health Sciences; Interventional Cardiology, Hamilton Health Sciences; Eli Lilly Canada,May Cohen Chair in Women's Health, McMaster University; Michael G. DeGroote-Heart and Stroke Foundation of Ontario Chair in Population Health Research, McMaster University; Population Genomics Program, McMaster University; McMaster University, Hamilton, ON, Canada). Identifying women with severe angiographic coronary disease. J Intern Med 2010; 268:66,74. Objectives., To determine sex/gender differences in the distribution of risk factors according to age and identify factors associated with the presence of severe coronary artery disease (CAD). Design., We analysed 23 771 consecutive patients referred for coronary angiography from 2000 to 2006. Subjects., Patients did not have previously diagnosed CAD and were referred for first diagnostic angiography. Outcome measures., Patients were classified according to angiographic disease severity. Severe CAD was defined as left main stenosis ,50%, three-vessel disease with ,70% stenosis or two-vessel disease including proximal left anterior descending stenosis of ,70%. Univariate and multivariate logistic regression was used to assess the association between risk factors and angina symptoms with severe CAD. Results., Women were less likely to have severe CAD (22.3% vs. 36.5%) compared with men. Women were also significantly older (69.8 ± 10.6 vs. 66.3 ± 10.7 years), had higher rates of diabetes (35.0% vs. 26.6%), hypertension (74.8% vs. 63.3%) and Canadian Cardiovascular Society (CCS) class IV angina symptoms (56.7% vs. 47.8%). Men were more likely to be smokers (56.9% vs. 37.9%). Factors independently associated with severe CAD included age (OR = 1.05; 95% CI 1.05,1.05, P < 0.01), male sex (OR = 2.43; CI 2.26,2.62, P < 0.01), diabetes (OR = 2.00; CI 1.86,2.18, P < 0.01), hyperlipidaemia (OR = 1.50; CI 1.39,1.61, P < 0.01), smoking (OR = 1.10; CI 1.03,1.18, P = 0.06) and CCS class IV symptoms (OR = 1.43; CI 1.34,1.53, P < 0.01). CCS Class IV angina was a stronger predictor of severe CAD amongst women compared with men (women OR = 1.82; CI 1.61,2.04 vs. men OR = 1.28; CI 1.18,1.39, P < 0.01). Conclusions., Women referred for first diagnostic angiography have lower rates of severe CAD compared with men across all ages. Whilst conventional risk factors, age, sex, diabetes, smoking and hyperlipidaemia are primary determinants of CAD amongst women and men, CCS Class IV angina is more likely to be associated with severe CAD in women than men. [source] Cardiovascular Interventions 2002: XIIIth International Course on Interventional Cardiology, Frankfurt/Main, GermanyJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 6 2002JÜRGEN HAASE M.D., Ph.D. [source] Progress in Interventional Cardiology: 3rd International Congress on Coronary Artery Disease From Prevention to InterventionJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 1 2001F.A.C.C., F.E.S.C., Herbert J. Geschwind M.D. [source] Cardiovascular Interventions 2000 XIth International Course on Interventional Cardiology, Frankfurt/Main, GermanyJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 6 2000JÜRGEN HAASE M.D., PH.D. [source] Progress in Interventional CardiologyJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 1 2000Jacob Joseph M.D. [source] Pediatric Interventional Cardiology in the United States is Dependent on the Off-label Use of Medical DevicesCONGENITAL HEART DISEASE, Issue 1 2010Jamie S. Sutherell MD ABSTRACT Objective., A substantial unmet medical device need exists in pediatric care. As a result, the off-label use of approved devices is routine in pediatric interventional cardiology, but the extent and nature of this practice has not been previously described. The purpose of this study, therefore, is to evaluate the prevalence and nature of off-label cardiac device use in an active pediatric interventional program in the United States. Study Design., This study is a retrospective review of all interventional cardiac procedures performed at our institution from July 1, 2005 to June 30, 2008. Diagnostic (noninterventional) catheterizations, myocardial biopsies, invasive electrophysiology studies, and studies involving investigational devices were excluded. Interventions performed were compared with the manufacturer's labeled indications for each device. Results., During this 3-year period, 473 patients (median age 4.1 years) underwent 595 transcatheter interventions. An approved device was utilized for an off-label application in 63% of patients, and in 50% of all interventions performed. The most frequent off-label procedures were stent implantations (99% off-label), balloon dilations (78% off-label), and coil embolizations (29% off-label). In contrast, the off-label use of septal and ductal occluders was relatively uncommon. Conclusions., In our routine (noninvestigational) practice of pediatric interventional cardiology, 63% of patients underwent procedures utilizing medical devices for off-label indications. These data underscore the need to enhance cardiac device review and approval processes in the United States to include pediatric applications. [source] Open-chest Epicardial Approach to Transcatheter Pulmonary Artery Stenting Following Heart Transplantation in an InfantCONGENITAL HEART DISEASE, Issue 1 2007Todd M. Gudausky MD ABSTRACT We describe an open-chest epicardial approach to transcatheter pulmonary artery stenting in a critically ill infant following heart transplantation. Technical considerations, indications, and feasibility are discussed. This case provides another example of the value of a "hybrid" approach (combining surgery and interventional cardiology) to complex congenital heart disease. [source] Door-to-Balloon Time: Performance Improvement in the Multidisciplinary Treatment of Myocardial InfarctionJOURNAL FOR HEALTHCARE QUALITY, Issue 4 2010J. Mark Peterman Abstract: The treatment of ST-elevation myocardial infarction with primary percutaneous coronary intervention is a time-sensitive process, with outcomes correlated with the speed with which the healthcare team can make the diagnosis, start preliminary treatment, and successfully perform the intervention. This requires multidisciplinary teamwork involving Emergency Medical Services, Emergency Medicine and Nursing, the cardiac catheterization laboratory team, and interventional cardiology. The success of effectively delivering treatment is enhanced through focused analysis of key steps within the care process to identify systems problems and implement quality improvement initiatives. This article reviews the process whereby our institution achieved top decile performance in this multidisciplinary treatment. [source] Editorial: At the Bifurcation of the Last FrontiersJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 4 2010THACH NGUYEN M.D. The concept of coronary angioplasty percutaneous coronary intervention (PCI) was pioneered by Andreas Gruntzig. Since then, several modifications, innovative devices, techniques, and advances have revolutionized the practice of interventional cardiology. Coronary bifurcation and chronic total occlusion are the last two frontiers that continue to challenge the skills of the interventional cardiologists. Proceedings of the second Bifurcation Summit held from November 26 to 28, 2009 in Nanjing, China are published in this symposium. In a general review, the state of the art in management of bifurcation lesion is summarized in the statement of the "Bifurcation Club in KOKURA." A new-presented concept was the "extension distance" between the main vessel and the sidebranch ostia and its association with restenosis. The results of two studies on shear stress (SS) after PCI showed that contradictory lower SS after stenting was associated with lower in-stent restenosis. There was better fractional flow reserve after double kissing crush technique than provisional one-stent technique. There was also lower rate of stent thrombosis after bifurcation stenting with excellent final angiographic results. In a negative note, the SYNTAX score had no predictive values on trifurcated left main stenting. In summary, different aspects of percutaneous management for bifurcated lesion are described seen from different perspectives and evidenced by novel techniques and strategies. (J Interven Cardiol 2010;23:293,294) [source] Update on Bioabsorbable Stents: From Bench to ClinicalJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 5 2006F.A.C.C., RON WAKSMAN M.D. Permanent metallic stents are associated with limitations such as continued mechanical stress, transfer to the tissue, and continued biological interaction with the surrounding tissue. They are also associated with late stent thrombosis and artifacts when non-invasive technologies such as MRI and MSCT are used. The potential advantages of bioabsorbable polymeric or metallic stents are to leave no stent behind, they are fully compatible with MRI and MSCT imaging, and are not associated with late stent thrombosis. This review covers the different stent programs as they move from bench to bed and clinical trials. Bioabsorbable stents are considered the next frontier of stenting and we will discuss their potential to fulfill this promise in interventional cardiology. [source] Polymer-Based Paclitaxel-Eluting Stents in Percutaneous Coronary Intervention:JOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 5 2004A Review of the TAXUS Trials Drug-eluting stents have altered the practice of interventional cardiology by dramatically reducing the risk of angiographic and clinical restenosis following percutaneous coronary intervention. Based on extensive preclinical study and clinical trial data, the polymer-based, slow rate-release paclitaxel-eluting TAXUS stent has recently received Food and Drug Administration approval for sale in the United States. In the current article, we review the available data from the TAXUS trials that have demonstrated that implantation of the slow rate-release TAXUS stent is safe and, in terms of restenosis, markedly superior to bare metal stenting for the treatment of de novo lesions <28 mm in length in arteries 2.5,3.75 mm in diameter. Additional trials in the TAXUS program are currently examining the role of slow and moderate rate-release polymer-based, paclitaxel-eluting stents in a broader range of clinical settings and lesion subsets. [source] The Role of Enoxaparin in Interventional Management of Patients with Acute Coronary SyndromesJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 5 2003CINDY L. GRINES M.D., F.A.C.C. Interventional management strategies involving early angiography and percutaneous coronary intervention (PCI) are increasingly widespread in the management of patients with acute coronary syndromes (ACS). Notwithstanding the benefits of early intervention, there is a significant risk of postprocedural thrombotic complications and a need to optimize antithrombotic regimens for use before and during PCI. It is clear that the current standard therapy with unfractionated heparin (UFH) and aspirin can be improved upon, in terms of both efficacy and safety. The low-molecular-weight heparin(s) (LMWHs) offer pharmacologic and practical advantages over UFH. The LMWH enoxaparin has recently emerged as the anticoagulant of choice for the acute management of ACS. Enoxaparin has also demonstrated sustained benefits over UFH in patients proceeding to PCI, and as a procedural anticoagulant. Combination therapy with enoxaparin and a glycoprotein IIb/IIIa inhibitor may further improve the efficacy and safety of antithrombotic treatment during coronary interventions, as a result of the drugs' complementary mechanisms of action. Early clinical evidence supports the use of enoxaparin in combination with glycoprotein IIb/IIIa inhibitors in high-risk patients with ACS. Ongoing, large-scale, randomized controlled studies will help to clarify the role of enoxaparin in interventional cardiology, either as the primary anticoagulant or as part of a combination regimen, and to define optimal regimens for treatment. (J Interven Cardiol 2003;16:357,366) [source] "Over-and-under" pericardial covered stent with paclitaxel balloon in a saphenous vein graft,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 6 2010Joanna J. Wykrzykowska MD Abstract Treatment of vein graft disease remains a challenge in interventional cardiology because of the risk of embolization and no-reflow phenomenon. Currently available distal protection devices have their limitations. The PTFE-covered stents may be well suited for venous graft lesion treatment, but those available commercially to date have poor crossing profiles, and deliverability and high rates of restenosis. We report the first use of over-and-under pericardium-covered stent in combination with drug-eluting balloon to treat venous graft disease. © 2009 Wiley-Liss, Inc. [source] Three-year follow-up of the first prospective randomized comparison between paclitaxel and sirolimus stents: The TAXi-LATE trialCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2007Alexandre Berger MD Abstract Goal: Analysis of the 3-year outcome of the original population of the TAXi trial which compared the efficacy of the paclitaxel (PES) and the sirolimus (SES) stents in a randomized "real world" investigation. History: The widespread use of drug-eluting stents strongly modified the world of interventional cardiology. The TAXi trial was a randomized comparison between PES and SES and showed similar efficacy between the two prostheses. Recently, emerging discussions raised questions about potential long-term risk with the use of DES. The present work attempts to describe the long-term outcome of the patients compared during the TAXi trial. Method: During April 2003 and January 2004, 202 patients were prospectively randomly assigned to the PES group (102 patients) and to the SES group (100 patients). The primary aim of the present investigation was the comparison of combined incidence of cardiac death, myocardial infarction, and target lesion revascularization within 36-months. Results: No difference in mortality of all causes was noted in the PES and the SES groups (3% vs. 7%, P = 0.98) or in major adverse cardiac event free survival (89% vs. 83%, P = 0.28). Four stent thromboses were observed, two in the PES group (205 and 788 days) and two in the SES group (210 and 772 days). Conclusion: The long-term outcome analysis of the TAXi trial confirms available published data showing the equivalence of PES and SES on clinical basis. © 2007 Wiley-Liss, Inc. [source] Overview of the 2006 Food and Drug Administration Circulatory System Devices Panel meeting on drug-eluting stent thrombosisCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2007Tina L. Pinto Slottow Abstract Drug-eluting stents (DES) seemed likely to mitigate the problem of restenosis and have become the predominant stent deployed during percutaneous coronary intervention (PCI). Sustained concerns about the rate of stent thrombosis (ST), particularly very late ST (>1 year following PCI) led to a meeting of the Circulatory System Devices Advisory Panel to address "on-label" and "off-label" use as well as appropriate duration of dual antiplatelet therapy following DES. Over 40 presentations by members of the FDA, industry personnel, and leaders in the field of interventional cardiology helped set forth the body of data available on DES. Standardized definitions of ST created by the Academic Research Consortium were applied to existing randomized trials and registries. At the end of the 2-day session, the consensus of the panel was that "on-label" DES use is not associated with increased incidence of death and myocardial infarction (MI), although it is associated with increased rates of very late ST. "Off-label" use is associated with increased risk of death or MI when compared with "on-label" use. Insufficient data exist to determine the duration of clopidogrel that would minimize ST and bleeding risk, but the panel agreed with the current ACC/AHA/SCAI guidelines regarding dual antiplatelet therapy for at least 12 months in patients at low risk for bleeding, especially with "off-label" use. More data from trials designed with better control arms and prespecified analyses of complex patients and lesions subsets over longer periods of follow-up are needed. © 2007 Wiley-Liss, Inc. [source] The intersection of PowerPoint and interventional cardiologyCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2002FSCAI President, Ted Feldman MD No abstract is available for this article. [source] Transcatheter Aortic Valve Replacement: A Potential Option for the Nonsurgical PatientCLINICAL CARDIOLOGY, Issue 6 2009Jigar H. Patel MD With improved life expectancy, the incidence of aortic stenosis is rising. However, up to one-third of patients who require lifesaving surgical aortic valve replacement are denied surgery due to a high operative mortality rate. Such patients can only be treated with medical therapy or percutaneous aortic valvuloplasty, neither of which has been shown to improve mortality. With advances in interventional cardiology, transcatheter methods have been developed for aortic valve replacement. Clinical trials are investigating these devices in patients with severe aortic stenosis that have been denied surgery. Preliminary results from these trials suggest that transcatheter aortic valve replacement (TAVR) is not only feasible, but an effective way to improve symptoms. In this review, we describe the current technology and display available outcome data. Though technical challenges and operator learning curve limit optimal use of the current technology, continued experience and advancements in technology may one day make TAVR a viable alternative to traditional surgical aortic valve replacement. Copyright © 2009 Wiley Periodicals, Inc. [source] | ||||||||||