Risks for Adverse Outcomes Associated with the Use of Hemostasis Devices

1
Risks for Adverse Outcomes Associated with the
Use of Hemostasis Devices

• Dale Tavris, MD, MPH
• Beverly Gallauresi, RN, MPH
• Ba Lin
• Suzanne Rich, RN, BA
• Richard Shaw, MD
• William Weintraub, MD
• Ralph Brindis, MD
• Kathleen Hewitt, RN
• Food and Drug Administration (FDA), Center
• for Devices and Radiological Health
• American College of Cardiology

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Background

• Reports to FDA 1996-2000
• - 1880 serious injuries
• - 36 deaths
• Female preponderance
• Types of hemostasis device
• - Collagen plug
• - Suture

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Rationale for Study

• Concern about safety of hemostasis devices from
  MDR reports
• Not obvious what to attribute injuries and deaths
  to
• Medical literature posed further cause for
  concern
• Previous studies characterized by small sample
  size and of institutions

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Comparison of sample size this study vs. 13
others
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MethodsStudy Population

• Cath lab admissions from ACC-NCDR registry
• Year 2001
• 166,680 subjects
• 214 institutions
• Excluded outpatients

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MethodsOutcomes

• Hemorrhage
• Occlusion
• Pulse loss
• Dissection
• Fistula
• Pseudo aneurysm
• Death

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MethodsStatistical Analysis

• Step-wise backwards multiple logistic regression
  analysis
• Hemostasis device use was main independent
  variable of interest
• Controlled for several potential confounding
  variables

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MethodsConfounding Variables

• Demographic age race gender body mass index
  (BMI)
• Co-morbidity NYHA class diabetes peripheral
  vascular disease hypertension myocardial
  infarction congestive heart failure acute renal
  failure
• Type of procedure (interventional vs. diagnostic
  catheterization)
• Presence of left main coronary artery stenosis
• Indication for procedure elective vs. emergency

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ResultsRate per 10,000 of local complications
by gender - year 2001 N 166,680
Pulse loss
Pseudo- aneurysm
Associated Death
Bleeding
10
ResultsRate per 10,000 of local complications
by type hemostasis - year 2001 N 166,680
Pseudo- aneurysm
Associated death
Pulse loss
Bleeding
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ResultsOther Major Findings

• Many co-morbid conditions highly associated with
  adverse events
• Multivariate analysis reduces but does not
  eliminate protective effect of hemostasis devices
• Protective effect of hemostasis devices evident
  for diagnostic but not interventional cardiac
  catheterization

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DiscussionPossible Reasons for Protective Effect
of Hemostasis Devices

• Protective effect of hemostasis devices was
  unexpected
• Possible explanation for apparent protective
  effects of hemostasis devices
• Unidentified confounding variable
• Misclassification of outcomes
• True protective effects

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DiscussionPossible Reasons for Differences
Between This and Other Studies

• Small sample sizes
• Single institution studies
• Improvements over time