Heart failure is one of the leading causes of mortality around the world. It usually affects older aged people, however, in recent times, the cases of heart attacks have been increasing among youth. Various treatment and management modalities have been developed for better therapy against heart failure. One of these modalities is the development of the Total Artificial Heart, which can replace the ventricles of your heart to improve pulmonary and systemic circulations.
The breakthrough
The Texas Heart Institute (THI) and BiVACOR®, a clinical-stage medical device company, announced today the successful first-in-human implantation of the BiVACOR Total Artificial Heart (TAH) as part of the U.S. Food and Drug Administration (FDA) Early Feasibility Study (EFS) on July 9, 2024.
The first-in-human clinical study aims to evaluate the safety and performance of the BiVACOR Total Artificial Heart as a bridge-to-transplant solution for patients with severe biventricular heart failure or univentricular heart failure in which left ventricular assist device support is not recommended. Following this first implantation completed at Baylor St. Luke’s Medical Center by Baylor College of Medicine surgeons, four additional patients are to be enrolled in the study.
“As for the implantation in the human, it went as expected with no complications. Clinically, the device performed very well,” said Dr. Alexis Shafii, surgical director of heart transplantation at Baylor St. Luke’s Medical Center and associate professor of surgery – cardiothoracic transplant & circulatory support at Baylor College of Medicine. “Having this technologically advanced device is offering something special in the field.”
“The Texas Heart Institute is enthused about the groundbreaking first implantation of BiVACOR’s TAH. With heart failure remaining a leading cause of mortality globally, the BiVACOR TAH offers a beacon of hope for countless patients awaiting a heart transplant,” said Dr. Joseph Rogers, President and Chief Executive Officer of The Texas Heart Institute and National Principal Investigator on the research. “We are proud to be at the forefront of this medical breakthrough, working alongside the dedicated teams at BiVACOR, Baylor College of Medicine, and Baylor St. Luke’s Medical Center to transform the future of heart failure therapy for this vulnerable population.”
What is a Total Artificial Heart?
A Total Artificial Heart is a mechanical pumping device that replaces the ventricles and valves of the heart to improve circulation. However, this device is considered to be a bridge-to-transplantation therapy for biventricular heart failure until patients receive a donor heart. On an average, a total artificial heart can last around 5 years.
What BiVACOR has created can help a patient to live for more than 8-10 years till they receive a donor heart if everything goes right. BiVACOR’s Total Artificial Heart is a titanium-constructed biventricular rotary blood pump with a single moving part that utilizes a magnetically levitated rotor that pumps the blood and replaces both ventricles of a failing heart.
The Total Artificial Heart (TAH) uses magnetic levitation, a technology similar to that found in high-speed trains. This innovative Total Artificial Heart has a unique pump design with only one moving part: a magnetically suspended dual-sided rotor. This rotor has left and right blades that are housed in two separate pump chambers. Together, these blades form a double-sided centrifugal impeller that moves blood from the chambers to the lungs and the rest of the body.
Unlike traditional hearts, this Total Artificial Heart doesn’t have valves or flexible chambers. Instead, it uses magnetic levitation (MAGLEV) to make the blood flow in pulses by quickly rotating the pump’s rotor. The MAGLEV technology suspends the rotor without any physical contact, which helps prevent mechanical wear and tear and provides larger gaps for blood flow. This design reduces blood damage and offers a durable, reliable, and biocompatible heart replacement.
Understanding heart failure
Heart Failure is a condition in which the heart is not able to sufficiently pump the blood to pulmonary and systemic circulation. Heart failure can be caused by several risk factors such as Coronary Artery Disease, Hypertension, Valvular Heart Disease, Cardiomyopathies, Genetic factors, etc.
This condition leads to less cardiac output of blood reaching the organs and can lead to shock. The sympathetic autonomic system would be activated which will cause vasoconstriction and increased heart rate. Reduced blood reaching the organs will lead to organ failure and can cause ischemia and organ failure.
Moreover, blood will be pooled peripherally in the venous system due to decreased cardiac function. This can lead to fatigue, swelling, and pitting edema of limbs. It can also cause respiratory problems such as dyspnea and orthopnea (which is shortness of breath when lying down on the back) due to pulmonary edema.
Drugs such as ACE inhibitors, Angiotensin-receptor Blockers, beta-blockers, and Aldosterone receptor Antagonists can reduce morbidity and mortality in Heart failure patients by decreasing cardiac remodeling. Diuretics and nitrate therapy also help in relief from acute symptoms of Heart Failure. PLEASE CONSULT YOUR DOCTOR BEFORE TAKING ANY MEDICATIONS.
Future implications
Daniel Timms, PhD, Founder and Chief Technology Officer of BiVACOR said, “I’m incredibly proud to witness the successful first-in-human implant of our TAH. This achievement would not have been possible without the courage of our first patient and their family, the dedication of our team, and our expert collaborators at The Texas Heart Institute. Utilizing advanced MAGLEV technology, our TAH brings us one step closer to providing a desperately needed option for people with end-stage heart failure who require support while waiting for a heart transplant. I look forward to continuing the next phase of our clinical trial.”
The successful implantation of the BiVACOR artificial heart heralds a new era in the treatment of heart failure. It provides a viable alternative for patients who are not candidates for traditional heart transplants, addressing the critical shortage of donor hearts. Moreover, it opens up new avenues for research and development in artificial organ technology.
BiVACOR’s achievement is expected to spur further advancements in artificial heart technology and improve the survival rates and quality of life for patients with end-stage heart disease. The company is already planning additional clinical trials to validate the device’s effectiveness and safety across a broader patient population.
