Permanent Artificial Heart Facts: History, Function, Options

The advent of the permanent artificial heart heralds a new era in the realm of medical achievements. Its presence in the market signifies not just a technological leap but a profound testament to human ingenuity. As we continue to unravel the complexities of the human body, the artificial heart stands as a symbol of our relentless pursuit of innovation to safeguard and enhance life. The symphony of life, with the heart at its center, now plays to the tune of both nature and technology, harmonizing in a delicate balance that holds the promise of a healthier and more resilient future. In this article, I am going to talk about the history, facts, and types of the permanent artificial heart.

Permanent Artificial Heart: Interesting Facts

The human heart, an organ of paramount importance, serves as the linchpin of the body’s intricate machinery. Nestled within the chest, it orchestrates the symphony of life by tirelessly pumping blood, ensuring the delivery of vital nutrients and oxygen to every nook and cranny of the body. The pulsating rhythm of the heart is not merely a physiological phenomenon; it is a symphony that sustains existence. Such a pivotal role makes the heart an object of both wonder and vulnerability.

A Revolutionary Leap: The Advent of the Permanent Artificial Heart

In the relentless pursuit of medical innovation, humanity has witnessed a groundbreaking development—the advent of the permanent artificial heart. This marvel of modern science stands as a testament to our unwavering commitment to extending the frontiers of healthcare. Unlike its organic counterpart, the artificial heart is a technological marvel, meticulously designed to replicate the intricate functions of the natural heart. It represents a beacon of hope for those grappling with cardiac challenges, offering a lifeline to patients in dire need of cardiovascular support.

Bridging the Divide: Market Availability and Patient Support

The integration of the permanent artificial heart into the market marks a significant milestone in medical history. Its availability signifies a transformative shift in the landscape of cardiac care, offering a beacon of hope for patients grappling with the daunting prospect of heart failure. As a technological marvel, this artificial organ is not merely a replacement but a bridge, seamlessly connecting the realms of human vulnerability and technological prowess. Its presence in the market not only broadens the horizons of treatment options but also reshapes the narrative of cardiovascular health.

Pioneering Innovation by Robert Jarvik, MD

Robert Jarvik, a distinguished figure in the medical field, stands acclaimed as the brilliant mind behind the revolutionary Jarvik 7, marking a pivotal moment in the realm of cardiac medicine. The year 1982 witnessed the groundbreaking event when the Jarvik 7 found its first home in the chest of Barney Clark, a patient whose journey captured the gaze of media outlets across the globe. Dr. Jarvik’s invention not only redefined medical possibilities but also sparked a wave of fascination and inquiry into the realm of artificial hearts.

The Significance of Permanent Artificial Hearts

A permanent artificial heart represents a remarkable technological marvel designed to assume the intricate responsibilities of the human heart. Frequently deployed as a means to bridge the critical gap before heart transplantation or as a definitive solution when transplant feasibility is compromised, these artificial hearts stand at the forefront of modern medical interventions. As we delve into the intricacies of their application, the profound impact of these devices on the landscape of cardiac care becomes increasingly apparent.

The Duality of Artificial Hearts

In the realm of cardiac care, the innovation of artificial hearts has manifested in two distinct forms: the total permanent artificial heart and the ventricular help machine. The former involves the complete elimination of the natural heart, paving the way for a synthetic substitute. On the other hand, the latter, known as the ventricular help machine, integrates with the existing natural heart, offering crucial support to its compromised functionality. This nuanced dichotomy prompts a profound consideration of the surgical choices available for patients in critical cardiac conditions.

The Intricacies of Heart Replacement

Dr. Jarvik, a prominent figure in cardiac innovation, embarked on the development of a groundbreaking ventricular help machine named the Jarvik 2000 in 1988. He articulates the gravity of heart removal, emphasizing its theatricality in the realm of surgical procedures. The inherent drama and complexity of such a procedure underscore the significance of artificial hearts in medical science.

While the limelight often gravitates towards total heart replacement, the poignant question emerges: In the face of a faltering limb, would one prefer an optimal artificial substitute or a device preserving the original, albeit impaired, limb? The rhetorical nature of the query prompts contemplation on the delicate balance between replacement and preservation.

The Symbiosis of Artificial and Natural

Although the replacement of a heart understandably captures more public attention, ventricular help machines find broader applications in patient care. Experts, recognizing the symbiotic relationship between the two modalities, view them as complementary therapies. While ventricular help units offer a lifeline to patients with compromised heart function, situations arise where a total artificial heart becomes imperative.

Notably, in cases of biventricular failure, where both sides of the natural heart falter, a complete artificial heart becomes a necessity. The intricate dance between artificial and natural solutions underscores the evolving landscape of cardiac interventions.

Evolution from Obscurity to Prominence

The landscape of mechanical hearts witnessed a transformative period in the 60s and 70s, marked by the discreet development of these groundbreaking devices by the National Institutes of Health (NIH). The unveiling of this medical marvel to the public occurred in 1967 when Christian Bernard conducted the first human heart transplant. This milestone event thrust heart replacement into the global spotlight, capturing the imagination of people worldwide.

Denton Cooley further propelled the field in 1969 by successfully implanting a temporary total artificial heart, sustaining the patient until a suitable donor could be secured. Over the subsequent decades, NIH-supported research culminated in the milestone creation of the Jarvik 7, representing the first total permanent artificial heart implanted as a lasting solution for a terminally diseased natural heart. This evolution from obscurity to prominence reflects the relentless pursuit of medical innovation in the domain of artificial hearts.

Evolution of Permanent Artificial Hearts: The Jarvik-7 Legacy

The inception of permanent artificial hearts can be traced through the corridors of time, with antecedent innovations dating back to the late 1940s. However, the watershed moment occurred in 1982 with the successful implantation of the Jarvik-7 in a human, a collaborative effort involving not only the visionary Robert Jarvik but also the esteemed Willem Johan Kolff. The Jarvik-7 not only etched its name in medical history but also set the stage for subsequent advancements in the field of artificial organ development.

Distinguishing Features of Permanent Artificial Hearts

It’s imperative to discern the subtle nuances that set a permanent artificial heart apart from other cardiac support devices. Unlike ventricular assist devices (VADs), specifically crafted to bolster a failing heart, a permanent artificial heart assumes a more comprehensive role, capable of completely taking over the vital functions of its biological counterpart. This distinctiveness emphasizes the profound nature of the innovation, marking a stride towards replicating and enhancing the intricacies of the human cardiovascular system.

Beyond Comparison: Permanent Artificial Heart vs. External Cardiovascular Support

A nuanced understanding emerges when comparing a permanent artificial heart to external devices like cardiopulmonary bypass machines. While the latter serves as a temporary substitute, intervening for a few hours during cardiac surgeries to support both heart and lung functions, a permanent artificial heart establishes itself as a lasting solution. It transcends the limitations of brief interventions, offering a sustained and integral replacement for a compromised heart, thereby redefining the boundaries of what medical science can achieve in the intricate dance of life and technology.

Inaugural Implantation of a Total Artificial Heart

On the transformative date of April 4, 1969, a groundbreaking medical event unfolded at The Texas Heart Institute in Houston. Two visionaries, Domingo Liotta and Denton A. Cooley, orchestrated the inaugural implantation of a total artificial heart. This technological marvel, nestled within the patient’s chest, served as a bridge while awaiting a heart transplant. The recipient, teetering on the brink of mortality, experienced a miraculous awakening and initiated the recovery journey.

After 64 hours, the pneumatic-powered artificial heart was delicately extracted, and seamlessly replaced by the beating cadence of a donor’s heart. However, tragedy struck thirty-two hours post-transplantation, shrouding the triumph in sorrow. A relentless acute pulmonary infection, intricately woven into both lungs by insidious fungi, unfurled its fatal consequences. The culprit, an immunosuppressive drug complication, cast a grim shadow over the pioneering procedure.

The tangible relic of this historic operation, the original Liotta-Cooley artificial heart prototype, now commands attention within the hallowed halls of the Smithsonian Institution’s National Museum of American History. It stands as a testament to the audacity of human innovation and the relentless pursuit of medical progress.

The Evolution of Jarvik 7

Transitioning through time, the Jarvik 7 heart emerged as a beacon of hope in the realm of cardiac interventions. Initially employed as a temporary total artificial heart, it skillfully bridged patients towards the prospect of transplantation. Beyond the initial five cases, the narrative of success unfolded, with the sixth patient claiming a robust five-year extension of life post-donor heart integration. Astonishingly, the seventh patient defied expectations, gracing existence with an additional eleven years alongside the donated heartbeat.

A silent triumph unfolded when another patient transitioned from the Jarvik 7 heart to a human heart, gifting fourteen more years of mundane, cherished existence. However, the accomplishments remained veiled from the prying eyes of the press, either overshadowed by more immediate news or perhaps deliberately omitted by the medical fraternity. Dr. Jarvik, undisturbed by the oversight, acknowledged that the silent victories were more than adequate.

Media’s Misconceptions and the FDA Odyssey

As the annals of time unfolded, a discordant note crept into the narrative. The press, oblivious to the ongoing successes, erroneously declared the cessation of Jarvik 7 heart usage after the initial five cases. Subsequently, a cascade of misinformation was perpetuated, suggesting that the Food and Drug Administration (FDA) had imposed a ban on its application. In a bizarre turn of events, the media began perpetuating the notion that the Jarvik 7 heart was a failed experiment, an assertion unfounded in the reality of its enduring achievements.

A decade-long odyssey ensued as the FDA meticulously investigated the outcomes, engaging 95 patients in its scrutiny. The findings, a resounding validation of success, revealed a 79% success rate for bridging to transplant and commendable overall survival rates, including transplant outcomes (70% at one year, 50% at five years, and 45% at eight years). In the United States, the Jarvik 7 (CardioWest) demonstrated unparalleled success, outshining any other total permanent artificial heart or ventricular support device ever conceived.

Jarvik 7 Triumphs: FDA Approval and Beyond

On the pivotal date of March 17, 2004, an FDA review panel, having scrutinized the wealth of data, delivered a resounding recommendation for PreMarket Approval (PMA) of the Jarvik 7 heart for bridge-to-transplant applications. This heralded a monumental milestone. On October 18, 2004, the FDA granted its unequivocal approval, etching the Jarvik 7 into the annals of medical history as the first total artificial heart to receive full FDA endorsement for any indication. Dr. Jarvik, with justified pride, asserted that far from being a failure, the Jarvik 7 Heart stands as a documented and resounding success, a triumph of human ingenuity and unwavering determination.

Navigating Challenges: The Intricacies of Artificial Heart Implementation

However, the journey towards widespread adoption and acceptance of the permanent artificial heart is not devoid of challenges. The intricate dance between human biology and technological innovation requires careful navigation. Medical professionals, researchers, and ethicists grapple with multifaceted considerations, from ensuring the device’s compatibility with the human body to addressing the ethical implications of artificial augmentation. Each step in this journey is a tightrope walk, demanding a delicate balance between pushing the boundaries of medical science and safeguarding the well-being of the patients.

Total permanent artificial heart prototypes

Total artificial heart pump
POLVAD
Phoenix-7
Abiomed AbioCor
SynCardia
MagScrew
Cleveland Heart
Abiomed AbioCor II
Carmat bioprosthetic heart
Frazier-Cohn
Soft artificial heart
A centrifugal pump
Axial-flow pump
Hybrid assistive units

Total Artificial Hearts: Pioneering Solutions to Organ Shortages

In the perpetual struggle against the scarcity of donor organs, the concept of sustaining life with mechanically engineered hearts has captured the imagination of medical researchers and practitioners for numerous decades. Total artificial hearts (TAHs) emerge as groundbreaking alternatives, intricately designed to replicate the intricate functionalities of the human heart. These artificial marvels represent a permanent solution, symbolizing the zenith of the relentless pursuit to combat cardiovascular failure.

As the demand for organ transplants surpasses the available supply, TAHs stand as a beacon of hope, offering a potential lifeline to those facing the dire prospect of heart failure. SynCardia, a trailblazing designer, has already introduced the sole TAH in the market, operating akin to a ventricular assist device (VAD). Functioning as a bridge to implantation, it serves as a crucial intermediary for patients awaiting a compatible donor heart. Intriguingly, various companies are on the cusp of revolutionizing this field, striving towards the development of fully realized, permanent artificial hearts. The imminent arrival of such advancements promises to redefine the landscape of cardiac interventions, with speculations pointing toward their commercial availability as early as 2020.

permanent artificial heart

Unraveling the Distinctions: Total Artificial Hearts vs. Ventricular Assist Devices

While the similarities between Total Artificial Hearts (TAHs) and Ventricular Assist Devices (VADs) are evident, a nuanced understanding of their divergences reveals the unique contributions each makes to the realm of cardiovascular medicine. VADs, serving as parallel counterparts, assist in the circulation of blood throughout the body by aiding the ventricles of the heart in their pumping function.

VADs, whether attached to the left (LVAD) or right ventricle, exhibit a remarkable ability to sustain cardiac function. In instances where both ventricles receive support, the apparatus earns the nomenclature of a biventricular assist machine (BIVAD). A critical distinction, however, surfaces when one delves into the nature of these devices. Unlike TAHs, VADs operate as assistive mechanisms. This means that the heart’s ventricles remain intact, necessitating a certain level of cardiac health for successful implantation. This prerequisite, unfortunately, is not always met, complicating the eligibility of potential recipients.

In the wake of these disparities, the market witnessed a transformative wave, with major medical device companies acquiring prominent LVAD manufacturers Thoratec and Heartware in 2015 and 2016, respectively. This strategic consolidation underscores the burgeoning significance and acceptance of VADs in the medical landscape despite their inherent limitations.

The Horizon of Tomorrow: Prospects for Fully Realized Artificial Hearts

As we navigate the evolving landscape of cardiac interventions, the quest for a definitive solution to organ shortages propels researchers towards the frontier of fully realized artificial hearts. Total Artificial Hearts (TAHs) are not just viewed as interim measures or bridges to transplantation but as destination therapies in their own right. The tantalizing prospect of a permanent solution looms on the horizon, with various companies making significant strides toward perfecting this revolutionary technology.

The race towards a fully realized artificial heart, distinct from the assistive nature of VADs, is characterized by its potential to reshape the paradigm of heart transplants. The culmination of these efforts promises a future where patients with failing hearts can turn to artificial organs as sustainable alternatives, reducing dependence on traditional donor transplants. The anticipation surrounding the potential market debut of a fully realized TAH by 2020 signifies a monumental stride towards overcoming the perennial challenge of organ scarcity and offers renewed hope for those awaiting cardiac interventions.

Risks of Investing in Artificial Hearts

Viability and Unforeseen Challenges in Medical Trials

Investing in Total Artificial Hearts (TAHs) hinges on the successful outcomes of medical trials. While initial results in bovine and human studies may appear promising, the unpredictability of unforeseen malfunctions could impede progress and escalate the overall cost of bringing these artificial hearts to the market. The delicate balance between innovation and unexpected setbacks poses a challenge in the journey toward the successful development of TAHs.

Specialist Centers and Industry-Medical Collaboration

The commercial success of emerging TAHs is intricately linked to the establishment of specialized centers for implantation. Beyond physical infrastructure, the collaboration between these cutting-edge technologies and the medical community plays a pivotal role. The companies’ effectiveness in engaging with key opinion leaders and fostering a symbiotic relationship with medical practitioners becomes a crucial factor influencing the broader adoption of artificial hearts.

Uncertainties in Medical Community Adoption

Even with the implementation of specialist centers and collaborative efforts, the speed at which the medical community embraces TAHs as a viable alternative to donor hearts and Ventricular Assist Devices (VADs) remains uncertain. The unknowns in terms of acceptance, concerns, and preferences among medical professionals add a layer of complexity to the investment landscape, making it challenging to predict the trajectory of artificial hearts within the healthcare ecosystem.

Regulatory Hurdles and Market Limitations

Navigating the regulatory landscape poses significant challenges for artificial hearts. Requirements such as the Premarket Approval Application (PMA) and humanitarian-use device (HUD) specifications could act as stumbling blocks. These hurdles might either narrow down the potential target market for artificial hearts or extend the developmental timeline. The delicate dance between regulatory compliance and innovation becomes a critical aspect that investors must carefully consider.

Manufacturing Scale-Up Challenges

Beyond regulatory considerations, scaling up the manufacturing of artificial hearts presents its own set of challenges. Meeting stringent quality standards and ensuring a steady supply of high-quality materials are prerequisites for large-scale production. The intricate balance between efficiency and maintaining the integrity of the devices further complicates the manufacturing process. Investors need to be mindful of these challenges as they evaluate the feasibility and scalability of investing in artificial hearts.

Evolution of Artificial Heart Designs

Since the groundbreaking first implant in 1969, medical researchers and teams worldwide have meticulously crafted and refined a total of 13 distinct artificial heart designs. Initially envisioned as permanent solutions to heart-related ailments, these innovations have found varied applications, primarily serving as temporary measures coined as a ‘bridge to transplant.’ This interim strategy ensures a patient’s survival until a suitable donor heart becomes available, offering a glimpse into the dynamic evolution of cardiac support technologies.

Triumph of the Temporary Total Artificial Heart (TAH)

Among the plethora of artificial heart designs, the Temporary Total Artificial Heart (TAH) stands as the solitary entity to have earned the coveted stamp of approval from regulatory authorities. Recognized and endorsed by the FDA in the United States, Health Canada, and Europe with the CE mark, the TAH has emerged as a stalwart in the medical arena. Over more than 35 years, this pulsatile marvel has been implanted in over 1,800 patients, contributing to an impressive tally of more than 600 patient-years of life-sustaining assistance.

Anatomy and Functionality of the TAH

Diverging from its predecessors, the TAH mirrors the intricacies of the human heart, boasting two ventricles and four valves. In an intricate procedure reminiscent of a heart transplant, the TAH seamlessly replaces both lower chambers (left and right ventricles) and all four heart valves. This intricate maneuver not only alleviates the symptoms of heart failure but also restores the essential blood flow throughout the body. A noteworthy departure from traditional heart transplants, the TAH is characterized by its on-demand availability, lack of constraints related to blood type or antibody levels, and remarkable biocompatibility, rendering the need for anti-rejection medications obsolete.

The Mechanics of Life: External Driver and TAH Integration

The orchestrated symphony of the Temporary Total Artificial Heart unfolds with the assistance of an external maestro—the driver. Acting as the conductor of this life-sustaining performance, the driver employs precision in generating pulses of air and vacuum. These carefully calibrated rhythms orchestrate the seamless flow of blood, facilitating the TAH’s critical function. In essence, this external symbiosis ensures that the TAH seamlessly integrates with the body’s circulatory system, mimicking the ebb and flow of a natural heartbeat with unparalleled precision and efficiency.

Crafting Durability and Compatibility: The SPUS Marvel

At the heart of the TAH’s structural integrity lies a remarkable material known as segmented polyurethane solution (SPUS). This bespoke substance, painstakingly manufactured in a laboratory nestled in Tucson, Arizona, possesses extraordinary attributes. Characterized by exceptional fatigue resistance, formidable strength, and unparalleled biocompatibility, SPUS emerges as the material of choice for crafting critical components of the TAH. This union of cutting-edge material science and medical innovation underscores the commitment to durability, functionality, and compatibility in the realm of artificial hearts.

Regulatory Landscape for Total Artificial Hearts

PMA and CE Mark Requirements

Total Artificial Hearts, categorized as medical devices, face distinct regulatory requirements. In the United States, they must undergo a Premarket Approval Application (PMA) process, while in the European Union, a CE mark from the European Medicines Agency is necessary. The stark contrast in regulatory pathways underscores the complexity of navigating global markets for artificial hearts.

Classifications: Class I, II, and III

Regulatory frameworks classify medical devices into Class I, II, and III. TAHs, falling under Class III, demand more rigorous scrutiny due to their higher risk. Class I products, on the other hand, are low-risk and require comparatively less clinical evidence for approval. The intricate categorization of devices reflects the nuanced approach regulators take, emphasizing the need for tailored evaluations based on risk levels.

PMA vs. HUD: Balancing Rigor and Market Reach

In the United States, the decision between PMA and HUD adds another layer of complexity. While the Humanitarian Use Device (HUD) pathway requires less clinical data for commercialization, it limits the product to benefit a maximum of 8,000 individuals. Opting for the more rigorous PMA route demands extensive efficacy data, a resource-intensive process that opens the door to a larger market. Striking the right balance between regulatory compliance, market reach, and development resources becomes a strategic consideration for investors in the artificial heart sector.

The Versatility of Total Artificial Hearts

The Total Artificial Heart (TAH) stands as a beacon of hope for a diverse range of individuals grappling with cardiac issues, spanning from tender ages as young as 9 to the seasoned age of 80. Its inclusive design addresses the unique needs of both genders and various age groups, emphasizing a personalized approach to healthcare.

Crafted with precision, the TAH comes in two distinct sizes, 70cc and 50cc, broadening its scope to accommodate a more extensive array of patients. The 70cc variant caters to a majority of males and select females, showcasing its adaptability. This model boasts the impressive capability of generating blood flow up to 9.5 liters per minute, a testament to its engineering prowess that aligns with the diverse physiological demands of patients.

On the other hand, the more compact 50cc TAH is meticulously designed to suit a majority of females and certain adolescents. Despite its smaller stature, this model is no less formidable, capable of sustaining blood flow of up to 7.5 liters per minute. To put this into perspective, the average human heart at rest pumps a mere 5 liters of blood per minute, underscoring the remarkable capabilities of the TAH. Health books, guides, exercises, habits, Diets, and more

Prolonged Lifespan on the TAH

The impact of the TAH extends beyond mere survival, as patients find themselves living on this artificial marvel for durations surpassing 4.5 years. While the typical duration of assistance for TAH patients hovers around 130 days, anecdotes abound of individuals defying the odds, with some enduring the support of the TAH for an impressive span. This underscores not only the life-saving nature of the device but also its capacity to offer a prolonged and improved quality of life.

Empowering Lives Beyond Hospital Walls

For stable TAH patients meeting the stringent discharge criteria, life extends far beyond the confines of the hospital. These individuals are not merely patients; they are vibrant contributors to their communities, relishing in the simple joys of an active life at home. The TAH grants them the privilege of spending precious moments with their loved ones while awaiting the serendipity of a compatible donor heart becoming available.

[Disclaimer: This article is based on several internet sources for information purposes only. There is no marketing intent behind this blog. Consult your physician or subject expert before you take any steps related to a permanent artificial heart]