Related Experiment Video

Updated: Apr 16, 2026

Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index
06:55

Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index

Published on: January 8, 2020

15.5K

A systematic review of ICD complications in randomised controlled trials versus registries: is our 'real-world' data

Vivienne A Ezzat1, Victor Lee1, Syed Ahsan1

  • 1The Heart Hospital , London , UK.

Open Heart
|March 7, 2015
PubMed

Insights

Implantable cardioverter defibrillator (ICD) complication rates vary significantly between randomized controlled trials (RCTs) and registries. Standardizing complication reporting is crucial for accurate patient safety assessments.

Area of Science:

  • Cardiology
  • Medical Device Technology
  • Clinical Research Methodology

Background:

  • Implantable cardioverter defibrillators (ICDs) are vital for preventing sudden cardiac death.
  • Published complication rates for ICD implantation are inconsistent, necessitating a comprehensive review.
  • Existing data lack standardization in complication classification and reporting.

Purpose of the Study:

  • To systematically review and meta-analyze complication rates from randomized controlled trials (RCTs) of ICD implantation.
  • To compare these findings with contemporary data from a large international registry (NCDR).
  • To highlight discrepancies and the need for standardized reporting of ICD complications.

Main Methods:

  • Systematic literature search of PubMed for RCTs involving ICD implantation (1999-2013).
  • Meta-analysis of 18 RCTs (6433 patients), excluding specific patient groups and procedures.
  • Comparison with data from the US National Cardiovascular Data Registry (NCDR) ICD registry (2006-2010).

Main Results:

  • Pooled complication rate in RCTs was 9.1% (displacement 3.1%, pneumothorax 1.1%, hematoma 1.2%, infection 1.5%).
  • NCDR registry reported a significantly lower major complication rate of 3.08% (displacement 1.02%, hematoma 0.86%, pneumothorax 0.44%).
  • No predictors for complications were identified, but longer follow-up showed a trend towards higher rates.

Conclusions:

  • RCTs report higher ICD complication rates (9.1%) compared to the NCDR registry (3.08%).
  • Discrepancies may stem from under-reporting in registries and variable reporting standards.
  • International standardization of ICD complication classification is urgently needed for accurate risk assessment.

Keywords:
QUALITY OF CARE AND OUTCOMES

More Related Videos

Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies10:38

Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies

Published on: January 16, 2019

21.1K
Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment08:36

Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment

Published on: April 19, 2024

1.4K

Related Concept Videos

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
579
Hazard Ratio01:12

Hazard Ratio

The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
737
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
5.5K
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
11.2K
Study Designs in Epidemiology01:20

Study Designs in Epidemiology

Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
1.6K
Nursing Interventions II: Selecting and Classifying the Nursing Interventions01:29

Nursing Interventions II: Selecting and Classifying the Nursing Interventions

Creating and executing a nursing diagnosis helps nurses plan care and guide patient, family, and community interventions. They are developed based on a patient's physical evaluation and support measuring the outcomes. It is not recommended to select random interventions throughout the planning process. Instead, consider the following six essential factors when choosing interventions:
3.7K