It is estimated that 26 million people worldwide and 6.2 million U.S. adults suffer from heart failure. Owing to the fact that not all of the patients can benefit from a heart transplant many patients have to wait for an available organ., and, in the case of severe heart failure, the wait is detrimental to one’s health. As a result, many of the people on the transplant lists die due to long waiting periods. This is because the demand for heart transplants is higher than the l supply. The average number of heart transplants done annually across the globe is less than 6,000, yet the U.S alone has approximately 100,000 ​potential patients.

The Urgent Need for Total Artificial Hearts

The efficacy of heart transplants in managing end-stage heart failure is well established. Unfortunately, the limited availability of donor hearts translates into protracted wait times for numerous patients several of whom do not survive the waiting period. For example, the American Heart Association reports that 18.7 percent of the total number of patients that need donation die during such waiting. For this reason, it is critical to explore alternative solutions that can be used by an individual in the time before a donor’s organ delivery or as a permanent solution. One of these options is the so-called Total Artificial Heart.

Heart Transplant Waiting List by State (Selected States)

(Source: SRTR Annual Data Report, 2022)

Recent Advancements in Total Artificial Hearts

1. CARMAT’s Aeson TAH

CARMAT's Aeson TAH, which received CE marking in Europe and FDA approval in the United States in 2020.  The product imitates the natural function of the human heart and is designed using biocompatible materials. The device’s adaptive heart rate changes depending on the activity that the patient is engaged in, facilitating a more accurate imitation of the user’s heart. Long-term artificial total heart replacement is intended for patients with end-stage heart failure.

2. BiVACOR’s TAH

An artificial heart of the new generation has introduced a heart replacement device designed using magnetic levitation, similar to that used in high-speed trains. Recently, the TAH was set in motion within a first-in-human trial at Baylor St. Luke’s Medical Centre. The impeller that delivers blood through the pulmonary and systemic circulatory systems on both sides is set in motion by a dual-sided centrifugal impeller. This design significantly reduces mechanical wear and blood trauma and improves the emergence of a resistant solution.

Pipeline Products

Several other companies are developing innovative TAH solutions:

• SynCardia Systems: Known for its 70cc and 50cc TAHs, which have been used in over 1,700 implants worldwide, providing temporary support for patients awaiting transplants.
• Abbott’s HeartMate 3: While primarily a left ventricular assist device (LVAD), ongoing research aims to adapt this technology for total heart replacement applications​ 

Impact on Patient Care and the Cardiovascular Market

The introduction of advanced TAHs like BiVACOR’s and CARMAT’s is poised to revolutionize patient care in several ways:

1. Reduced Mortality Rates: Offering a viable bridge or permanent solution, these devices can cut the number of deaths among patients waiting for a heart transplant
2. Improved Quality of Life: AHs can enhance patients’ quality of life by providing superior hemodynamic support and reducing various complications of severe heart failure.
3. Market Growth: The expected expansion of the cardiovascular devices market should not be underestimated, with special attention on the opposite alternatives​. Therefore, as one of the innovative solutions, that will become approved by the regulatory authorities or gain specific recognition on the market, their devices will be attractive for investment.

Financial Impact

BiVACOR and CARMAT’s recent breakthroughs justifiably receive much attention. As their clinical trials are still in progress and the devices still have much potential for adoption, and they are likely to claim a large share of the market for cardiovascular devices, an increase in IHCA applications is expected to have a strong positive effect on their financial performance and forecasts​. In conclusion, total Artificial Hearts are one of the prospective solutions to the severe problems in heart transplantation. They are, in particular, both satisfied to be the gap in the availability of donor organs. These devices are critical tools to incorporate advanced technologies as well as innovative designs for designing mechanisms for appropriate support of patients with terminal heart failure; such companies as BiVACOR and CARMAT are working on them. With the upcoming advances, such devices will have a dramatic impact on a decade of cardiovascular medicine. Would it be a joint problem to add provision of these services to a new era in cardiac care, and what could be possible to address any possible challenges for implementation, such are some of the questions that remain unclear to me at all.

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