The Total Artificial Heart: Where Are We?

The total artificial heart (TAH) is a device that replaces the failing ventricles. There have been numerous TAHs designed over the last few decades, but the one with the largest patient experience is the SynCardia temporary TAH. The 50-mL and 70-mL sizes have been approved in the United States, Europe, and Canada as a bridge to transplantation. It is indicated in patients with severe biventricular failure or structural heart issues that preclude the use of a left ventricular assist device. The majority of the patients implanted are Interagency Registry for Mechanically Assisted Circulatory Support profile 1 or 2. The 1-year survival in experienced centers that have implanted over 10 TAHs is 73%. The risk factors for death include older age, need for preimplantation dialysis, and malnutrition. The most common causes of death are multiple organ failure, usually the result of physiologic deterioration before implantation, and neurologic dysfunction. The device allows the patient to be discharged home and managed as an outpatient. Proper patient selection, the timing of intervention, patient care, and device management are essential for a suitable outcome. In addition, the CARMAT TAH is another device that will soon be studied in a clinical trial in the United States. The BiVACOR TAH is a revolutionary design utilizing electromagnetic levitation that is expected to enter a clinical trial in the next few years.

Artificial hearts-recent progress: republication of the article published in the Japanese Journal of Artificial Organs.

This review was created based on a translation of the Japanese review written in the Japanese Journal of Artificial Organs in 2015 (Vol.44, No. 3, pp.130-135), with some modifications regarding several references published in 2015 or later.

The Carmat Bioprosthetic Total Artificial Heart Is Associated With Early Hemostatic Recovery and no Acquired von Willebrand Syndrome in Calves.

OBJECTIVES: To determine hemostasis perturbations, including von Willebrand factor (VWF) multimers, after implantation of a new bioprosthetic and pulsatile total artificial heart (TAH). DESIGN: Preclinical study SETTING: Single-center biosurgical research laboratory. PARTICIPANTS: Female Charolais calves, 2-to-6 months old, weighing 102-to-122 kg. INTERVENTIONS: Surgical implantation of TAH through a mid-sternotomy approach. MEASUREMENTS AND MAIN RESULTS: Four of 12 calves had a support duration of several days (4, 4, 8, and 10 days), allowing for the exploration of early steps of hemostasis parameters, including prothrombin time; coagulation factor levels (II, V, VII+X, and fibrinogen); and platelet count. Multimeric analysis of VWF was performed to detect a potential loss of high-molecular weight (HMW) multimers, as previously described for continuous flow rotary blood pumps. Despite the absence of anticoagulant treatment administered in the postoperative phase, no signs of coagulation activation were detected. Indeed, after an immediate postsurgery decrease of prothrombin time, platelet count, and coagulation factor levels, most parameters returned to baseline values. HMW multimers of VWF remained stable either after initiation or during days of support. CONCLUSIONS: Coagulation parameters and platelet count recovery in the postoperative phase of the Carmat TAH (Camat SA, Velizy Villacoublay Cedex, France) implantation in calves, in the absence of anticoagulant treatment and associated with the absence of decrease in HMW multimers of VWF, is in line with early hemocompatibility that is currently being validated in human clinical studies.

New Innovations in Circulatory Support With Ventricular Assist Device and Extracorporeal Membrane Oxygenation Therapy.

The past decade has seen an exponential increase in the application and development of durable long-term as well as nondurable short-term mechanical circulatory support for cardiogenic shock and acute or chronic heart failure. Support has evolved from bridge-to-transplant to destination therapy, bridge to rescue, bridge to decision making, and bridge to a bridge. Notable trends include device miniaturization, minimally invasive and/or percutaneous insertion, and efforts to superimpose pulsatility on continuous flow. We can certainly anticipate that innovation will accelerate in the months and years to come. However, despite-or perhaps because of-the enhanced equipment now available, mechanical circulatory support is an expensive, complex, resource-intensive modality. It requires considerable expertise that should preferably be centralized to highly specialized centers. Formidable challenges remain: systemic inflammatory response syndromes and vasoplegia after device insertion; postoperative sepsis; optimal anticoagulation regimens to prevent device-induced thrombosis and cerebral thromboembolism; wound site, intracranial, and gastrointestinal bleeding; multisystem injury and failure; patient dissatisfaction (even when providers consider the procedure a "success"); and ethical decision making in conditions of futility.

Past and Present of Total Artificial Heart Therapy: A Success Story.

The totally artificial heart (TAH) is among the most prominent medical innovations of the 21st century, especially due to the increasing population with end-stage heart failure. The progressive course of the disease, its resistance to conventional therapy, and the scarcity of hearts available for transplantation were the prime impetus for developing a TAH, especially when other options of mechanical circulatory assist devices are exhausted. In this review, we narrate the history of TAH, give an overview of its technology, and address the pros and cons of the currently available TAH models in light of published clinical experience.

Total Artificial Hearts-Past, Current, and Future.

We present a review of the evolution of total artificial hearts (TAHs) and new directions in development, including the coupling of VADs as biventricular TAH support.

Advances in mechanical assist devices and artificial hearts for children.

PURPOSE OF REVIEW: Mechanical circulatory support (MCS) has rapidly evolved toward continuous flow technology in adults. In the pediatric population, the Berlin EXCOR, a paracorporeal pulsatile pump, is the only MCS device specifically approved for pediatric use. The current era of pediatric MCS includes an increasing application of adult continuous flow pumps to pediatric patients. RECENT FINDINGS: The Berlin EXCOR pulsatile pump has been studied in over 200 patients. The major limitations of this device are neurologic dysfunction (which occurs in about 30% of supported patients) and the requirement for in-hospital care until transplant. Two continuous flow pumps (HVAD and HeartMate II) have been successfully applied in children and adolescents, and the SynCardia total artificial heart has been used in adolescents. The National Heart, Lung, and Blood Institute - sponsored Pediatric Mechanically Assisted Circulatory Support registry has collected pediatric MCS data since 2012 and will provide valuable outcomes data to help refine this field. Survival with these durable devices has been generally good (except for small infants and patients with complex congenital heart disease), with nearly 50% receiving a heart transplant within 6 months. Patients with single ventricle physiology continue to pose major challenges. Two clinical trials for miniaturized adult continuous flow devices and one trial for a new pediatric pump will begin within the next year. SUMMARY: New continuous flow devices are entering or poised to enter clinical trials. If approved, these devices will enhance the safety and variety of options for longer-term pediatric support.

Artificial organs 2014: a year in review.

In this Editor's Review, articles published in 2014 are organized by category and briefly summarized. We aim to provide a brief reflection of the currently available worldwide knowledge that is intended to advance and better human life while providing insight for continued application of technologies and methods of organ Replacement, Recovery, and Regeneration. As the official journal of the International Federation for Artificial Organs, the International Faculty for Artificial Organs, the International Society for Rotary Blood Pumps, the International Society for Pediatric Mechanical Cardiopulmonary Support, and the Vienna International Workshop on Functional Electrical Stimulation, Artificial Organs continues in the original mission of its founders "to foster communications in the field of artificial organs on an international level." Artificial Organs continues to publish developments and clinical applications of artificial organ technologies in this broad and expanding field of organ Replacement, Recovery, and Regeneration from all over the world. We take this time also to express our gratitude to our authors for offering their work to this journal. We offer our very special thanks to our reviewers who give so generously of time and expertise to review, critique, and especially provide meaningful suggestions to the author's work whether eventually accepted or rejected. Without these excellent and dedicated reviewers, the quality expected from such a journal could not be possible. We also express our special thanks to our Publisher, John Wiley & Sons, for their expert attention and support in the production and marketing of Artificial Organs. We look forward to reporting further advances in the coming years.

The evolving role of the total artificial heart in the management of end-stage congenital heart disease and adolescents.

Advances in medical therapies have yielded improvement in morbidity and a decrease in mortality for patients with congenital heart disease, both surgically palliated and uncorrected. An unintended consequence is a cohort of adolescent and adult patients with heart failure who require alternative therapies. One intriguing option is placement of a total artificial heart (TAH) either as a bridge to transplant or as a destination therapy. Of the 1091 Jarvik-7 type TAH (Symbion, CardioWest and SynCardia) placed between 1985 and 2012, only 24 have been performed in patients with congenital heart disease, and a total of 51 were placed in patients younger than 21. At our institution, the SynCardia TAH was implanted in a 19-year-old patient with cardiac allograft failure because of chronic rejection and related multisystem organ failure including need for hemodialysis. Over the next year, she was nutritionally and physically rehabilitated, as were her end organs, allowing her to come off dialysis, achieve normal renal function and eventually be successfully transplanted. Given the continued growth of adolescent and adult congenital heart disease populations with end-stage heart failure, the TAH may offer therapeutic options where previously there were few. In addition, smaller devices such as the SynCardia 50/50 will open the door for applications in smaller children. The Freedom Driver offers the chance for patients to leave the hospital with a TAH, as does the AbioCor, which is a fully implantable TAH option. In this report, we review the history of the TAH and potential applications in adolescent patients and congenital heart disease.

Total artificial heart.

End-stage heart failure represents a highly morbid condition for the patient with limited treatment options. From a surgical perspective, the treatment options for effective long-term survival are usually limited to heart transplantation, heart-lung transplantation or implantation of a destination mechanical circulatory support device. Assuming an advanced heart-failure patient is indeed deemed a candidate for transplantation, the patient is subject to shortages in donor organ availability and thus possible further decompensation and potential death while awaiting transplantation. Various extracorporeal and implantable ventricular-assist devices (VADs) may be able to provide temporary or long-term circulatory support for many end-stage heart-failure patients but mechanical circulatory support options for patients requiring long-term biventricular support remain limited. Implantation of a total artificial heart (TAH) currently represents one, if not the best, long-term surgical treatment option for patients requiring biventricular mechanical circulatory support as a bridge to transplant. The clinical applicability of available versions of positive displacement pumps is limited by their size and complications. Application of continuous-flow technology can help in solving some of these issues and is currently being applied in the research towards a new generation of smaller and more effective TAHs. In this review, we discuss the history of the TAH, its development and clinical application, implications for anaesthetic management, published outcomes and the future outlook for TAHs.

From artificial kidneys to artificial hearts and beyond: new developments offer great hope.

Artificial organs have already become an important part of medical care, and with the advent of new devices, materials, and approaches, either in development or already on the market, they will become even more commonplace in the future.