Right Ventricular Failure After Implantation of Left Ventricular Assist Devices

Completed

Conditions studied: Heart Failure

In brief

The left ventricular assist device (LVAD) is a portable mechanical pump that helps the left side of the heart of patients with severe heart failure that are awaiting heart transplantation or are not transplant candidates. However, while LVAD supports the left side of the heart, the right side must work on its own. Sometimes the right side does not recover, a condition called right ventricular failure (RVF). This complication increases mortality, prolongs hospitalization, requires additional procedures, and increases costs. Several risk factors and scores have been proposed to identify patients at risk for RVF. However, these methods have proven inadequate; one out of three patients is still experiencing right ventricular failure after LVAD surgery. Echocardiography, an established noninvasive method to see the heart without radiation or risk, has a lot of potential to identify patients at risk for RVF. The questions we will tray to answer with this American Heart Association funded project are: 1. Can echocardiography before scheduled LVAD surgery predict who is going to develop RVF and poor quality of life so we can better select patients for LVAD surgery? 2. Can echocardiography before scheduled LVAD surgery tell us the course of right ventricular function after implantation so we can potentially take additional measures and prevent RVF? To answer these questions, we will record images of the heart with echocardiography before LVAD surgery in 120 LVAD recipients at Emory University. We will then follow the patients for 90 days to detect any symptoms and signs of clinical RVF and poor quality of life and record the course of right ventricular function with echocardiography. Currently, it is estimated that 150,000 to 250,000 patients in US are potential LVAD recipients with 2,000 devices implanted in 2012. LVAD can improve survival and quality of life in suitable patients. However, implantation requires a major surgical procedure with associated risks and considerable resources. Thus, careful patient selection is necessary to minimize risk for patients and maximize benefit for patients and society. Our long-term goal is to use echocardiography as a tool to (1) optimally select patients for LVAD and offer alternatives to patients at increased risk for complications and (2) potentially, inform earlier LVAD implantation in patients with weakening right ventricular function.

Key facts

Study ID

NCT01999712

Run by

Emory University

People needed

83

Starts

2013-07-01

Expected to finish

2017-12-31

Last updated by the study team

2018-05-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-75 years
• Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Class 2-7
• Willing to participate
• Able to give consent

You may not qualify if…

• INTERMACS Class 1
• Pre-operative advanced RVF, defined as planned or anticipated need for RVAD or extracorporeal membrane oxygenation at surgery
• Unresponsive pulmonary vascular resistance (PVR) >6 Wood units

Where it is running

• Emory University Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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