Reader Response Draft #4

The article “Replacing Hearts. Restoring Lives” (BiVACOR, n.d.) introduces the first long-term therapy for people with severe biventricular heart failure. BiVACOR’s Total Artificial Heart (TAH) is a treatment option for individuals in the final stages of heart failure who require assistance while awaiting a heart transplant or are ineligible for transplantation. The article also states that the BiVACOR system consists of a rotor suspended using advanced magnetic levitation (MAGLEV), positioned between opposing pump enclosures. Its central capability is to assist both the left and right sides of the heart, facilitated by impeller blades for each side, attached to the revolving core. The core is elevated and set in motion through an electromagnetic motor and bearing configuration situated atop the pump enclosures. According to the article, the impellers are specifically engineered hydraulically and, when coupled with MAGLEV technology, allow precise control over circulation adjustment through a differential fluid discharge. With advanced technology, the BiVACOR TAH is a clear improvement over SynCardia’s TAH in terms of the amount of time the device can provide support to patients, material used, and the mechanism of the TAH.

 

Pertaining to the amount of time the device can provide support to patients, BiVACOR provides a significantly longer support time as compared to Syncardia. The Syncardia TAH diaphragm, which pumps blood into and out of the ventricles, has demonstrated a failure rate of less than 1% in more than 1,000 implants (SynCardia, 2023), and the current longest duration of support after transplantation in a man is 3.75 years (Copeland, n.d.). In contrast, with a lifespan of at least 10 years, BiVACOR’s TAH can last much longer because the rotating disk is able to levitate without causing mechanical wear or friction (Park, 2021). Although the failure rate of SynCardia’s TAH is proven to be low, BiVACOR’s TAH is shown to be able to provide at least twice the duration of time able to provide support to patients.

 

Moreover, the material used for BiVACOR is more durable as compared to SynCardia. A highly specialised segmented polyurethane solution is used for manufacturing the housings, diaphragms, and connectors for the SynCardia TAH (SynCardia, n.d.). In the article “Plastics and the artificial heart” (Bregar, 2017), Dr. Billy Cohn mentioned that artificial hearts that use multi segmented polyurethane membranes that were fed air through hoses can carry bacteria that can infect the heart. Unlike the SynCardia TAH, the BiVACOR TAH has almost no mechanical wear because of the high-tech rotary pump's levitation between magnets. The rest of the heart may be made from ultra-robust titanium because it has no other moving parts (Ireland, 2021). With the advancement from plastic to metal, the BiVACOR TAH reduces the rate of infection and is proven to be longer-lasting than SynCardia’s.

 

Regarding mechanisms, BiVACOR’s TAH runs on an electromagnetic mechanism while SynCardia’s TAH runs pneumatically. Four valves and two biocompatible plastic ventricles make up the SynCardia TAH. The internal chamber, where the blood flows, and the external chamber, where the pneumatic mechanism runs, are separated by a diaphragm in each ventricle (SynCardia, 2023). In contrast, the BiVACOR TAH uses a spinning disc suspended in a magnetic field rather than a mechanical pump that replicates the four chambers of the human heart. The BiVACOR TAH [BB1] [BB2] only has one working part, which allows it to pump oxygen-rich blood out to the body and return blood that is low in oxygen to the lungs (Greatrex et al., 2019). Thus, with the use of electromagnetism in the BiVACOR TAH, the advanced mechanism could potentially lead to better durability of the device.

 

However, a major concern regarding the BiVACOR TAH is that it has yet to be approved by the American Food and Drug Administration (FDA). The SynCardia TAH is the first biventricular cardiac replacement approved by the FDA for bridge to transplantation and holds the European Union Conformite Europeenne (CE) mark, which certifies that a product has met EU health, safety, and environmental requirements. It is a tried-and-true device for recovering potential transplant candidates who rapidly decompensate from biventricular failure or who have chronic heart failure (Copeland et al., 2021). Nonetheless, with great advancements in the device, there is a high probability that the BiVACOR TAH will be FDA-approved in the near future.

 

In conclusion, with the significant contrast in the amount of time the devices are able to provide support to patients, durability of the materials used, and the advanced mechanism used in the devices, BiVACOR’s Total Artificial Heart shows superiority over SynCardia’s Total Artificial Heart.

References

BiVACOR. (n.d.). BiVACOR. https://bivacor.com/

 

Bregar, B. (2017, July 6). Plastics-and-the-artificial-heart. Plastics News. https://www.plasticsnews.com/article/20170706/NEWS/170709964/plastics-and-the-artificial-heart

Copeland, J., Langford, S., Giampietro, J., Arancio, J., & Arabia, F. (2021). Total Artificial Heart Update. Surgical technology international, 39, 243–248. https://doi.org/10.52198/21.STI.38.CV1449

 

Copeland J. G. (2013). SynCardia Total Artificial Heart: update and future. Texas Heart Institute journal, 40(5), 587–588.

 

Greatrex, N., Kleinheyer, M., Nestler, F., & Timms, D. (2019, September). This Maglev Heart Could Keep Cardiac Patients Alive. IEEE Spectrum. https://spectrum.ieee.org/this-maglev-heart-could-keep-cardiac-patients-alive

 

Ireland, T. (2021, July 4). Artificial hearts made from magnets and titanium could save many lives. BBC Science Focus. https://www.sciencefocus.com/news/artificial-hearts-made-from-magnets-and-titanium-could-save-many-lives

 

Park, A. (2021, May 20). Bivacor lands $22M to begin human trials of its magnetic artificial heart. Fierce Biotech.

https://www.fiercebiotech.com/medtech/bivacor-lands-22m-venture-capital-and-nih-funds-to-begin-human-studies-artificial-heart

 

SynCardia. (n.d.). Give patients the gift of time. SynCardia. https://syncardia.com/total-artificial-heart-50-cc-and-70-cc/

 

            SynCardia. (2023, March 20). Syncardia Total Artificial Heart - Mercé V. Electromedicina.                    Mercé Electromedicina. https://mercev.com/en/heart-failure-syncardia/