The First Titanium Heart Transplant

In the most recent groundbreaking medical breakthroughs of 2024, The Texas Heart Institute and BiVACOR®, a clinical-stage medical device company, announced on July 25th, 2024 that the first human implantation of the BiVACOR’s Total Artificial Titanium Heart occurred at Baylor St. Luke’s Medical Center in Houston, Texas. As an early feasibility study fundamental to the U.S. Food and Drug Administration (FDA), the device is the first successful artificial implant to utilize magnetic levitation technology. Here’s an insight into this groundbreaking titanium heart transplant.

How the Titanium Artificial Heart Works

BiVACOR’s Total Titanium Artificial Heart (TAH) offers a potential treatment for patients with severe univentricular or biventricular heart failure, particularly when left ventricular support devices are not recommended. The size of the artificial heart is appropriate for both men and women, despite its compact dimensions. Although this titanium heart is entirely artificial, it effectively pumps blood thanks to its unique pump design. 

BiVACOR highlights that the Total Artificial Heart utilizes magnetic levitation technology, featuring a magnetic double-sided rotor with left and right vanes arranged within two pump chambers. This design forms a circular deviating impeller that effectively supplies blood from the artificial chambers to the pulmonary and systemic circulations of the body. Although this total artificial heart lacks flexible ventricular chambers and valves, the magnetic levitation technology enables pulsatile blood flow through the pump’s rotor. The non-contact suspension of the rotor reduces the risk of mechanical wear and friction, resulting in a durable, functional, and reliable biocompatible heart replacement. Currently, no substantial evidence predicts how long the device will function before a patient receives a donor's heart; however, this BiVACOR design has been successfully operating for four years and counting in the lab.

A Possible Solution to the Epidemic

Artificial hearts are at the forefront of extending and improving the quality of life of transplant-eligible patients who are at risk of impending death due to severe heart failure. With heart failure being one of the leading causes of mortality in the United States, heart failure continues to be a prevalent global epidemic affecting approximately 26 million individuals worldwide and 6.2 million American adults. Such growing prevalence in this epidemic has implemented limited heart transplant procedures per year globally only to a select few with severe heart failure. As a result, the National Institutes of Health in the United States estimated approximately 100,000 patients could benefit from BiVACOR’s Total Artificial Heart.

Within days of this groundbreaking medical breakthrough, an additional four patients were scheduled to undergo the TAH implant procedure as part of the FDA’s Early Feasibility Study (EFS). Dr. Joseph Rogers, President and Chief Executive Officer of the Texas Heart Institute of National Principle Investigator, expressed his enthusiasm about the implant because it offers a beacon of hope for many patients who have been awaiting a heart transplant for an extended amount of time. Alongside Dr. Rogers, Daniel Timms, PhD, Founder and Chief Technology Officer of BiVACOR, shared his satisfaction with the success of the first-in-human TAH implant and expressed gratitude to the first patient and their family for participating in the FDA’s EFS. He emphasized the potential of innovative technologies to enhance the quality of cardiac care.

Takeaways

This successful implantation highlights the new potential of such medical technologies while addressing the critical challenges posed by long transplantation waitlists. The device has shown promise in improving quality of life outcomes soon after implantation. BiVACOR’s Total Artificial Heart (TAH) aims to not only alleviate the symptoms of heart failure—such as decreased mobility, shortness of breath, and fatigue—but also to serve as a viable treatment option that can provide long-term support for patients with end-stage heart failure.

Written by Sarosh Momin 

Edited by Iana Malasevskaia, MD

References:

1. Cassella, Carly. “World First: Heart Made from Titanium Kept a Man Alive for Days.” ScienceAlert, 2 Aug. 2024, www.sciencealert.com/world-first-heart-made-from-titanium-kept-a-man-alive-for-days.   Accessed 8 Aug. 2024. 
2. “Fellows Implant World-First Magnetic Levitation Artificial Heart.” ACS, 2024, www.facs.org/for-medical-professionals/news-publications/news-and-articles/acs-brief/august-6-2024-issue/fellows-implant-world-first-magnetic-levitation-artificial-heart/.  Accessed 8 Aug. 2024.
3. Sprung, Keri. “The Texas Heart Institute Implants BiVACOR® Total Artificial Heart.” The Texas Heart Institute®, 25 July 2024, www.texasheart.org/the-texas-heart-institute-implants-bivacor-total-artificial-heart/.  Accessed 8 Aug. 2024.
4. Walter, Michael. “Texas Surgeons First in World to Perform “Groundbreaking” Total Artificial Heart Procedure.” Cardiovascular Business, 25 July 2024, cardiovascularbusiness.com/topics/clinical/cardiac-surgery/texas-surgeons-first-world-bivacor-total-artificial-heart.  Accessed 8 Aug. 2024.