Propensity Score Analysis of Vascular Complications after Diagnostic Cardiac Catheterization and Percutaneous Coronary Intervention Using Thrombin Hemostatic Patch-Facilitated Manual Compression
ABSTRACT: Objectives. To evaluate the adjusted risk of vascular complications after thrombin hemostasis patch-facilitated manual compression (THP-MC) for femoral artery access site management. Background. Thrombin hemostatic patches shorten time to hemostasis after cardiac procedures involving femoral artery access, but whether these patches are as safe as manual compression remains uncertain. Methods. THP-MC (D-Stat Dry, Vascular Solutions, Minneapolis, Minnesota) was used in 3,464 consecutive patients including 2,464 diagnostic cardiac catheterizations (CATH) and 1,000 percutaneous coronary intervention procedures (PCI) performed via a femoral access at a single site (WFUBMC). A total of 4,371 procedures including 2,956 CATH and 1,415 PCI performed prior to use of THP-MC, and treated with manual compression, served as the control group. Ambulation was permitted 2?3 hours after THP-MC, and 3?8 hours after MC. Propensity to receive a THP was calculated, and adjusted inhospital outcomes evaluated. Results. Time to hemostasis was similar for THP-MC (13.0 ± 3.3 min) compared to MC (14.4 ± 5.7 min), p = 0.51 for CATH, and was shorter for THP-MC (14.2 ± 5.4 minutes) compared to MC (20.1 ± 5.4 min), p <0.001, for PCI. Overall, the unadjusted incidence of any vascular complication (VC) was 0.6% for THP-MC and 1.0% for manual compression, p = 0.036. The propensity score-adjusted odds ratio for any VC comparing THP-MC to manual compression was 0.58 (0.34?0.99) for all procedures, 0.42 (0.20?0.87) for diagnostic procedures and 0.86 (0.39?1.88) for PCI. Conclusions. In this large, single-center, contemporary observational study, use of THP-MC shortened manual compression time for PCI procedures, permitted early ambulation and was as safe as conventional manual compression.
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Safety and Efficacy of a 6 French Perclose Arterial Suturing Device Following Percutaneous Coronary Interventions: A Pilot Evaluation
Background. Arterial access site management after percutaneous coronary intervention (PCI) is a matter of increasing importance in this era of potent antiplatelet pharmacotherapy. We evaluated the safety and efficacy of a 6 French (Fr) Perclose suturing device in achieving rapid hemostasis of the access site after PCI and thus improving patient comfort. Methods. The 6 Fr Perclose (Prostar) device consists of a suture-based closure device delivered via introducer sheath designed for suturing of the arteriotomy puncture site. Over a 3-month period, the device was used in 48 consecutive PCI treated patients (age, 62 ± 13 years; 70% male; 44% post myocardial infarction) and in-hospital groin complication rate was compared to 48 consecutive patients (age, 64 ± 12 years; 64% male; 33% post myocardial infarction) who had manual compression hemostasis. Results. Antiplatelet glycoprotein IIb/IIIa antagonists were used more frequently during and following the procedure in 58% of Perclose-treated patients versus 42% of the manual compression group (p = 0.019). Leg immobilization duration was 3?4 hours in all patients sutured by the device; in patients with manual compression, the sheath was removed at an average of 4.8 ± 2.5 hours after termination of the PCI and an additional 6 hours of leg immobilization were subsequently required. No difference in overall major complication rate was found between groups (6.2% in suture-mediated patients versus 9.3% in manual compression group; p = 0.60). In 3 patients (6.2%) treated using the device, adjunctive manual compression was required in addition to groin suturing due to technical failure or residual oozing from the arteriotomy site. Conclusion. The 6 Fr Perclose device can be safely used to achieve rapid hemostasis and the device may hasten bed mobilization of PCI-treated patients despite frequent use of potent antiplatelet pharmacotherapy during coronary interventions.
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PCI with and without Abciximab after Upstream Eptifibatide Use: Outcomes in High-Risk Patients
ABSTRACT: Background. Abciximab is often used to treat high-risk patients during percutaneous coronary intervention (PCI). Recent data indicate, however, that upstream and postprocedural treatment with low-dose glycoprotein (GP) IIb/IIIa inhibitors may be more beneficial than abciximab during and after PCI. Whether abciximab can be used safely or effectively during PCI for high-risk patients after upstream treatment with eptifibatide in patients with acute coronary syndromes (ACS) is not known. Methods. Clinical outcomes were evaluated in 289 patients with ACS who had upstream treatment with eptifibatide, and abciximab (EA) during PCI, and compared to 560 ACS patients who had both upstream and interventional treatment with eptifibatide (EE). Results. Bleeding and vascular complications of the two groups were similar. Overall, 1-year major adverse cardiac event (MACE) rates were similar: 26.0% in the EA group and 25.2% in the EE group; p = 0.82. In patients with unstable angina, the hazard of MACE at 1 year was higher with EA than EE, 1.98 (1.23?3.18), due to significantly higher rates of repeat revascularization in the EA group. In patients with myocardial infarction (MI), the hazard of MI or death at 1 year was lower in the EA than the EE group, 0.50 (0.27?0.93). Conclusion. In this single-center observational study, the use of abciximab for PCI after upstream use of eptifibatide for ACS was safe. Abciximab was of no benefit in patients with unstable angina, but was associated with lower MI or death in patients with MI. These observations are consistent with recent findings indicating that abciximab is of benefit in patients with NSTEMI, but not lower-risk patients.
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Current Results of Balloon Aortic Valvuloplasty in High-Risk Patients
ABSTRACT: In this report, we describe our experience with a contemporary series of patients with severe aortic stenosis (AS) undergoing balloon aortic valvuloplasty (BAV) who were not deemed to be surgical candidates. Demographic, hemodynamic and procedural data, operative risk (EuroSCORE) and long-term follow up were collected. Eighty consecutive patients with severe symptomatic AS underwent 104 BAV procedures as a single center and were followed for a mean of 3 ± 2 years. Thirteen patients underwent 2 BAV procedures, 2 patients underwent 3 BAV procedures and 1 patient underwent 5 BAV procedures. Mean age was 81 ± 10 years, and 23% were > 90 years of age. Cardiogenic shock was present in 20% and the ejection fraction was < 30% in 38% of the patients. The mean EuroSCORE was 16 ± 5, and 98% had a high-risk EuroSCORE. There were no procedural deaths and 9 (9%) total vascular complications. In-hospital, 1-, 2- and 3-year mortality rates were 6%, 44%, 62% and 71%, respectively. Seventeen patients (21%) underwent repeat BAV procedures and had long-term mortality similar to those undergoing a single BAV procedure. Contemporary BAV has acceptable short- and long-term results and can effectively be used for patients deemed unsuitable surgical candidates and those at highest operative risk, such as patients with cardiogenic shock.
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Clinical Experience with a Circumferential Clip-Based Vascular Closure Device in Diagnostic Catheterization
Background. The StarCloseô Vascular Closure System (Abbott Vascular Devices, Redwood City, California) utilizes a small, flexible nitinol clip to complete a circumferential, extravascular closure of the femoral arteriotomy site. The StarClose is an investigational device in the United States, limited by Federal law to investigational use. The StarClose is CE Mark approved. Methods. The CLIP study was a prospective, randomized, multicenter trial utilizing a noninferiority design to compare the rate of major vascular complications and time-to-hemostasis using the StarClose system versus manual compression. A total of 596 subjects were enrolled, 208 of whom underwent diagnostic angiography. This diagnostic subset is the focus of this report. The primary safety endpoint was major vascular complications and the primary efficacy endpoint was time-to-hemostasis. All patients were followed at 30 days with a clinical exam. Results. Subjects were randomized 2:1 to the StarClose (n = 136) or manual compression (n = 72). There were no major vascular complications in either group. Minor vascular complications occurred in 3 StarClose patients (2.2%), and 1 manual compression patient (1.4%) (p = 1.00). Use of the StarClose device reduced mean time-to-hemostasis from 15.47 ± 11.4 to 1.46 ± 4.5 minutes (p < 0.001) when compared to manual compression, and reduced the average time-to-ambulation from 269 ± 135 to 163 ± 105 minutes (p = < 0.001). Device success was 94.1% (127/135), and procedural success was 100% (136/136). Conclusion. The clinical results of this study concluded that the StarClose Vascular Closure System is noninferior to standard compression with respect to the the primary safety endpoint of closing arteriotomies in patients who undergo percutaneous diagnostic procedures.
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Overcoming Heparin Limitations in High-Risk Percutaneous Coronary Intervention: The Alternative Strategy ? Replacing Heparin with Bivalirudin (Part I)
Overcoming Heparin Limitations in High-Risk Percutaneous Coronary Intervention: The Alternative Strategy ? Replacing Heparin with Bivalirudin (Part I) Feature: Overcoming Heparin Limitations in High-Risk Percutaneous Coronary Intervention: The Alternative Strategy ? Wilson et al.69 showed that after a 10,000 U heparin dose, ACT levels were significantly lower among PCI patients with acute MI (189 seconds), UA with prior heparin (221 seconds) and UA patients with no prior heparin (248 ...
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Impact of Gender on Femoral Access Complications Secondary to Application of a Collagen-based Vascular Closure Device
Impact of Gender on Femoral Access Complications Secondary to Application of a Collagen-based Vascular Closure Device ORIGINAL ARTICLES: Impact of Gender on Femoral Access Complications Secondary to Application of a Collagen-based Vascular Closure Device - Holger Eggebrecht, MD, Clemens von Birgelen, MD, PhD, Christoph Naber, MD, Knut Kröger, MD* Axel Schmermund, MD, Heinrich Wieneke, MD, Thomas Bartel, MD, Uta Wörtgen, MD, Dietrich Baumgart, MD, Michael Haude, MD, Raimund Erbel, MD ABSTRACT:...
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Long-Term Warfarin and Percutaneous Intervention
Long-Term Warfarin and Percutaneous Intervention Commentary: Long-Term Warfarin and Percutaneous Intervention - Sanjeev Vaderah, MD and John Webb, MD Despite improvements in interventional procedural techniques and equipment, vascular and bleeding complications remain a too frequent complication of percutaneous coronary intervention (PCI). Hemostasis in fully anticoagulated patients undergoing intervention ...
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 Electrophysiologic Perspective on the BIPOLAR RF EPICARDIAL ABLATION Procedure for Atrial Fibrillation
Complimentary Accredited Breakfast Symposium
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Location: The St. Regis San Francisco
125 3rd Street
San Francisco, CA 94103
3rd and Mission Streets
Gallery Ballroom, 2nd floor
This activity is supported by an educational grant from AtriCure, Inc.
This program is not part of the Heart Rhythm 2008 Official Scientific Sessions as planned by the Heart Rhythm Society Scientific Sessions Committee. This event is neither sponsored nor endorsed by the Heart Rhythm Society.
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 Newest Perspectives on Drug-Eluting Stents
Complimentary CME Accredited Dinner Meetings Click Here for More Info.
Miami, FL - Date: Friday, April 4, 2008 6:00pm EST -8:00 pm EST
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This activity is supported by an educational grant from Abbott Vascular.
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 CLINICAL EXPERIENCE WITH A NEW HYBRID CORONARY WIRE
On Demand Web Archive
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This activity is supported by an educational grant from Terumo Medical Corporation.
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 Pharmacoinvasive Management of Acute Coronary Syndrome: Incorporating the 2007 ACC/AHA Guidelines
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This activity is supported by an educational grant from Sanofi-Aventis.
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 Varicose Veins: Causes, Symptoms, Diagnosis and Treatment of Chronic Venous Insufficiency
A Complimentary Accredited ON-DEMAND Webcast
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 Create a Successful Vena Cava Filter Practice
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This activity is supported by an educational grant from Cook Incorporated and has been designed for Interventional Cardiologists, Vascular Surgeons, Fellows and Interventional Cardiovascular Nurses and Technologists.
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 Achieving Optimal Outcomes in Carotid Stenting: Lessons Learned from Recent Clinical Trials
Complimentary Accredited ON DEMAND Webcast
Topics
1. EVA-3S & Space-Bumps in the road
2. CAPTURE 3500-Lesion morphology & Predictors for Stroke
3. CAPTURE II vs. EXACT 1500-Does open or Closed Cell Stent design really matter?
This activity has been developed for Interventional Cardiologists, Vascular Surgeons, Interventional Radiologists, Neurologists, Interventional Nurses and Technologists with an interest in the diagnosis and treatment of peripheral artery disease. |
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 Anticoagulation Techniques for Peripheral Vascular Interventions
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This activity has been developed for Interventional Cardiologists, Vascular Surgeons, Interventional Radiologists, Podiatric Physicians, Endovascular Allied Professionals, Endocrinologists, Wound Care Specialists, Directors of the Wound Care Clinic, and Primary Care Physicians, Pharmacists, Nurses and Technologists.
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 New Treatment Strategies for the Endovascular Approach to Critical Limb Ischemia: ADVANCEMENTS IN LIMB SALVAGE MEDICINE
Complimentary Accredited ON DEMAND Webcast
This activity has been developed for Interventional Cardiologists, Vascular Surgeons, Interventional Radiologists, Podiatric Physicians, Endovascular Allied Professionals, Endocrinologists, Wound Care Specialists, Directors of the Wound Care Clinic, and Primary Care Physicians, Pharmacists, Nurses and Technologists.
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 Reducing the Incidence of CIN during Cardiac Catheterization and PCI
Complimentary Accredited ON DEMAND
Educational Web Archive
This activity has been developed for nurses and technologists. |
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March 2007 Supplement
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Archived Webcast
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Release Date: December 8, 2006