Automated Surveillance to Detect Postprocedure Safety Signals of Approved Cardiovascular Devices

Bivalirudin and Provisional Glycoprotein IIb/IIIa Blockade Compared With Heparin and Planned Glycoprotein IIb/IIIa Blockade During Percutaneous Coronary Intervention

2003 • 1,176 citations

Comparison of a Polymer-Based Paclitaxel-Eluting Stent With a Bare Metal Stent in Patients With Complex Coronary Artery Disease

2005 • 764 citations

Some Methods of Propensity‐Score Matching had Superior Performance to Others: Results of an Empirical Investigation and Monte Carlo simulations

2009 • 698 citations

Arterial Puncture Closing Devices Compared With Standard Manual Compression After Cardiac Catheterization

2004 • 554 citations

Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures

2004 • 442 citations

The Relative Ability of Different Propensity Score Methods to Balance Measured Covariates Between Treated and Untreated Subjects in Observational Studies

2009 • 408 citations

The American College of Cardiology-National Cardiovascular Data Registry™ (ACC-NCDR™): building a national clinical data repository

2001 • 372 citations

Drug-Eluting or Bare-Metal Stents for Acute Myocardial Infarction

2008 • 247 citations

Antithrombotic Strategies in Patients With Acute Coronary Syndromes Undergoing Early Invasive Management

2007 • 243 citations

The New Sentinel Network — Improving the Evidence of Medical-Product Safety

2009 • 220 citations

The Rosiglitazone Story — Lessons from an FDA Advisory Committee Meeting

2007 • 208 citations

Long-Term Clinical Outcomes After Drug-Eluting and Bare-Metal Stenting in Massachusetts

2008 • 150 citations

Risk of local adverse events following cardiac catheterization by hemostasis device use and gender.

2004 • 148 citations

Surveillance of Medical Device–Related Hazards and Adverse Events in Hospitalized Patients

2004 • 145 citations

INTERMACS: Interval Analysis of Registry Data

2009 • 94 citations

Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention

2003 • 80 citations

Clinical characteristics and in-hospital outcome of patients with end-stage renal disease on dialysis referred for implantable cardioverter-defibrillator implantation

2009 • 74 citations

Predictors of complications and learning curve using the Angio-SealTM closure device following interventional and diagnostic catheterization

1999 • 65 citations

The National ICD Registry: Now and into the future

2006 • 57 citations

Recalls and Safety Alerts Affecting Automated External Defibrillators

2006 • 57 citations

Modernizing Device Regulation

2010 • 53 citations

Frequency and Clinical Consequences Associated With Sidebranch Occlusion During Stent Implantation Using Zotarolimus-Eluting and Paclitaxel-Eluting Coronary Stents

2009 • 52 citations

Postmarket evaluation of breakthrough technologies

2008 • 35 citations

Risk-adjusted sequential probability ratio test control chart methods for monitoring operator and institutional mortality rates in interventional cardiology

2007 • 35 citations

Part I: identifying holes in the safety net

2004 • 27 citations

Validation of an Automated Safety Surveillance System with Prospective, Randomized Trial Data

2008 • 21 citations

Medical device vigilance at FDA.

1996 • 20 citations

Exploration of a Bayesian Updating Methodology to Monitor the Safety of Interventional Cardiovascular Procedures

2004 • 19 citations

Monitoring Device Safety in Interventional Cardiology

2005 • 18 citations

Rare adverse event monitoring of medical devices with the use of an automated surveillance tool.

2007 • 12 citations

Part II: sealing holes in the safety net

2004 • 8 citations