The Epidemiology of Ventricular Assist Device-Related Infections

Study Overview
=================
Brief Summary
-----------------
Infections often occur after ventricular assist devices (VADs) are placed. These infections can be very serious. The goal of this study is to understand why these infections occur. Bacteria (germs) normally live on our skin and in our noses. After surgery, they can infect the VAD. The investigators will collect cultures of your skin and nose before and after surgery. The investigators will compare these bacteria to bacteria that cause infections. Their genes will be compared to see which ones help the bacteria cause infection.

Detailed Description
-----------------
Infections are one of the most serious of ventricular assist device (VAD) related complications. Many of these infections are associated with significant patient morbidity and mortality. Diagnosis of these infections is often difficult due to the complicated nature of the patient's medical problems, the need for rapid institution of empiric antibiotic therapy and the lack of established criteria that define infection. Staphylococci are among the most common causes of VAD infections. The basis for this high incidence is not well understood but is believed to be in part due to inoculation of staphylococcal commensal flora into wound sites at the time of surgery or thereafter. The goals of this observational study are to develop a better understanding of the pathogenesis and epidemiology of Staphylococcus aureus and epidermidis-VAD infections as well as to develop a set of criteria that can be used to help diagnose the presence or absence of a VAD related infection. This is a prospective, multi-center, observational study to identify risk factors associated with the development of VAD-related infections. Patients will be followed for up to one year following VAD implantation, time of death or transplantation, whichever comes first. There will be no randomization for this observational study.

Official Title
-----------------
The Epidemiology of Ventricular Assist Device-Related Infections

Conditions
-----------------
Congestive Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years. Approved by the institution's heart failure/transplant committee for VAD implantation, either as a bridge to cardiac transplantation or for destination therapy for end-stage heart failure. Signed informed consent, release of medical information, and HIPAA forms. Expectation of compliance with protocol procedures and study visit schedule.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Population<br>150 subjects with end-stage heart failure who have been scheduled to undergo device implantation with a VAD, either as a bridge to cardiac transplantation or for destination therapy. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of suspected infections, characterized by infecting organism and location. | The primary goal is to collect information that describes infections in patients receiving LVADs. | Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and quantify culture results for suspected infections and the secondary manifestations of infection | Bacteria normally live on our skin and in our noses.After surgery, they can infect the VAD. We will collect cultures before and after surgery and compare these bacteria to bacteria that cause infections.Their genes will be compared to see which ones help the bacteria cause infection. We hope this will help develop new ways to help prevent VAD infections. | Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first. | 
| Develop Guidelines to properly diagnose VAD infections | Information will be collected on patient's medical condition after surgery including blood tests to help determine if an infection is present. | Up to one year following VAD implantation, time of death or transplantation, whichever comes first. | 
| Costs (direct) | The value of all resources that are consumed in the provision of an intervention or dealing with the side-effects or other current and future consequences linked to it. | Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first. | 
| Adverse Events | Since this is an observational study there will be no adverse events directly attributable to a study intervention. However, adverse events that might potentially contribute to the risk or course of VAD-related infections will be monitored. | Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first. |