Heart Failure with Reduced Ejection Fraction (HFREF)
Ejection fraction (EF) is the percentage of blood that is pumped out of the heart’s left ventricle with each contraction. A normal ejection fraction is 50% - 70%. An ejection fraction below 50% is considered “low.” Heart failure is a condition where the heart muscle doesn’t pump blood as well or efficiently as it should to meet your body’s needs.
It is a life-altering chronic condition and can lead to reduced quality of life and possibly death.
If you have heart failure, your symptoms may include:
• Shortness of breath
• Fatigue
• Reduced ability to perform physical activity
• Lightheadedness
• Fluid in the lungs
• Swelling in the legs
• Rapid or irregular heartbeat
Current treatment includes medication and implantation of an Implantable Cardio-Defibrillator (ICD) or a pacemaker for Cardiac Resynchronization Therapy (CRT). If you are suffering from severe heart failure, you may require an LVAD or be eligible for a heart transplant.
How Revivant therapy may treat heart failure:
Revivent Therapy is an investigational cardiac remodeling technique performed by a cardiothoracic surgeon under general anesthesia. It is designed to treat patients with heart failure and reduced ejection fraction originating from a heart attack or chronic low blood supply that caused significant scarring of the front (anterior) wall of the heart. The procedure is performed through an incision between the ribs on the left side of the chest. Unlike traditional heart surgery, there is no need to have a sternotomy (cutting the breastbone) or use cardiopulmonary bypass (heart lung machine) during the procedure. During the procedure, a special device is used to implant anchors into the scar tissue in the heart. Once the anchors are in place, the surgeon will gently pull them toward each other, resulting in exclusion of the scar tissue from the healthy tissue on the left ventricle. This isolates the damaged part of the heart and may allow the remaining healthy tissue to work more effectively. The procedure is designed to reshape the heart toward a more normal shape, and may improve pumping efficiency, thereby increasing blood flow to the rest of the body.
RELIVE Clinical Trial:
Randomized Evaluation of Less Invasive Ventricular Enhancement (RELIVE) is a prospective, multi-center randomized trial comparing the Revivent Procedure plus Guideline Directed Medical Therapy (GDMT) to GDMT alone for the treatment of Left Ventricular anterior/apical scar/aneurysm with possible additional involvement of the lateral, septal, and/or inferior regions in patients with symptomatic heart failure. Enrollment in the trial is based on specific clinical measurements. If you qualify and agree to enroll in the trial, you will be randomly selected for either the treatment or control group. The trial randomizes two patients to the treatment for every patient in the control group, so that there is a two-thirds chance you will receive the device.
What can you expect before the procedure?
Certain physical and clinical evaluations will need to be carried out before the procedure.
These include, but are not limited to the following:
• Cardiac examination including heart rate, blood pressure, NYHA class, bloodwork, ECG, and review of cardiac medications
• Measuring the distance you walk for 6 minutes (”6 Minute Walk Test”)
• Transthoracic or Transesophageal echocardiogram (ultrasound test for the heart)
• CT/MRI Scans – imaging assessment of the heart and identification of the scar location to determine accurate implant using the Revivent System
What can you expect after the procedure?
Once the Revivent Procedure is complete, you will be transferred to the cardiac monitoring unit for about 1-2 days. After this, your cardiologist may transfer you to the regular hospital ward before discharge. Additional tests may be performed after the procedure to ensure all structures in your heart are working properly. As part of the clinical study, you will be required to follow up with your cardiologist at 1, 6, and 12 months and annually for 5 years after your procedure to get a routine patient cardiac exam and undergo an echocardiogram (ultrasound). In addition, a CT scan is performed at 6 months. Your cardiologist may also determine that additional tests are required.
Are you Eligible for the RELIVE study?
If you are 18 years or older, suffer from heart failure symptoms despite taking medication and meet study criteria, you may be eligible to participate.
For more information talk to your doctor or visit: www.bioventrix.com