Thromboembolic Complications After Pacemaker or Implantable Cardioverter-Defibrillator Procedures

Thromboembolic Complications Associated With Pacemaker or Implantable Cardioverter-Defibrillator Procedures: a Prospective Registry

This is a large prospective registry of patients submitted to cardiac electronic devices implantation designed to investigate the incidence, risk factors and prognostic of thromboembolic complications associated with transvenous lead implantation.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Disease; Venous Thrombosis; Pulmonary Embolism; Arrhythmias; Bradyarrhythmias

Detailed Description

More than 235.500 cardiac pacemakers and cardioverter-defibrillators are implanted in the US every year, with an estimated 25,000 new implants in Brazil. Despite its proven clinical effectiveness and efficacy for a number of clinical conditions such as arrhythmias, the number of adverse events in the post-implant period remains substantial. Among these complications, venous obstructions occurs anywhere between 14% and 64% of all patients, causing devastating consequences such as upper extremity deep venous thrombosis and pulmonary embolism, ultimately leading to either significant impairment or death. Although retrospective studies have demonstrated the high incidence of these complications, as a consequence of a paucity of reliable registries we know next to nothing regarding how these venous lesions may influence the clinical outcome and mortality of patients, whether laboratorial markers may contribute to the early diagnosis of venous thrombosis and its complications, and about properties of diagnostic imaging for the identification of thromboembolic complications after permanent transvenous leads implantation.

The objective of this study is therefore to propose a significant improvement in an existing clinical database located within the Heart Institute (INCOR) at the University of Sao Paulo to enable the provision of answers to a clinical, biomarker, and imaging-related research questions. Specifically, our aims are to:

• Aim 1 - Registry infrastructure: In collaboration with professors from Duke University, we will create a series of improvements to the current database to enable it to serve as a platform not only for the current studies but also for future longitudinal, randomized studies. These include the standardization of variables in accordance with international guidelines, increase in patient retention and the ability to have additional data points in-between clinical appointments, improvement in the determination of cause of mortality, data quality monitoring, the creation of an item bank to measure aspects of quality of life that are specific for this population, as well as the integration of images and biomarkers to the clinical database.
• Aim 2 - Diagnostic imaging methods: To identify the incidence of upper extremity deep venous thrombosis after cardiac devices implantations or reoperation procedures, as well, the incidence of symptomatic and asymptomatic pulmonary thromboembolism.
• Aim 3 - Prognostic clinical factors: To study the impact of thromboembolic complications in the clinical prognostic and mortality of patients;
• Aim 4 - Prognostic biomarkers: To determine the association between the biomarkers related with alterations in the hemostasis system and the occurrence of venous thrombosis (biomarkers: Fibrinogen, D Dimer, Antithrombin, Prothrombin fragment 1 +2, thromboxane B, Platelets, Plasminogen)

At the end of this study we will have a registry with one of the largest number of patients with this condition around the world, fully equipped for future randomized controlled trials. We will also have a much better understanding regarding clinical, imaging, and biomarkers for this condition.

• Study Type: Observational
• Enrollment (Anticipated): 1

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-900
    • Recruiting
    • Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
    • Contact: Katia R Silva, RN PhD; Phone Number: 5284 55-11-2661; Email: katia.regina@incor.usp.br
    • Principal Investigator: Roberto Costa, MD PhD
    • Principal Investigator: Katia R Silva, RN PhD
    • Sub-Investigator: Martino Martinelli Filho, MD PhD
    • Sub-Investigator: Mario Terra Filho, MD PhD
    • Sub-Investigator: Wilson Mathias Jr, MD PhD
    • Sub-Investigator: Marta F Lima, MD PhD
    • Sub-Investigator: Roberto A Rached, MD PhD
    • Sub-Investigator: Claudio L Lucarelli, MD PhD
    • Sub-Investigator: Francisco C Carnevale, MD PhD
    • Sub-Investigator: Airton M Moreira, MD PhD
    • Sub-Investigator: Wagner T Tamaki, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients

Description

Inclusion Criteria:

• Older than 18 years
• Pacemaker/ implantable-cardioverter defibrillator (ICD) / cardiac resynchronization therapy (CRT) initial implant by transvenous approach or
• Patients submitted to reoperation procedures, as: pulse generator replacement, implant of an additional lead, lead extraction, lead repositioning;
• Subject agreed to participate and signed the consent form

Exclusion Criteria:

• Patients with a history of venous thromboembolism, coagulopathy or malignancy
• Pregnancy
• Life expectancy of less than one year
• Contraindication to administration of iodinated contrast (creatinine > 3.0)
• Unable to attend the follow-up appointments

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Implantation Procedures; Patients submitted to initial pacemaker or ICD implantation
Reoperation Procedures; Patients submitted to pacemaker or implantable cardioverter-defibrillator generator replacements, upgrade procedures and lead extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thromboembolic complications	Upper extremity deep venous thrombosis Pulmonary embolism All cause mortality	Participants will be evaluated at 1, 6, 12 months after the surgical procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous lesions	Venous stenosis (any degree) detected by subtraction venography	Participants will be evaluated at 12 months after the surgical procedure

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Duke University
• Investigators: Principal Investigator: Katia R Silva, RN PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): April 1, 2014
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: September 30, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (Estimate): October 30, 2012

Study Record Updates

• Last Update Posted (Estimate): May 7, 2013
• Last Update Submitted That Met QC Criteria: May 4, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Venous thrombosis; Pulmonary embolism; Biological markers; Pacemaker; Computed tomography angiography; Phlebography; Implantable-cardioverter defibrillator; Cardiac Pacing, Artificial/adverse effects
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Cardiovascular Diseases; Embolism; Bradycardia; Thrombosis; Venous Thrombosis; Pulmonary Embolism
• Other Study ID Numbers: CAPPesq: 0730/11