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Frazier OH, Shah NA, Myers TJ. Total Artificial Heart.
In: Cohn LH, Edmunds LH Jr, eds. Cardiac Surgery in the Adult. New York: McGraw-Hill, 2003:15071514.

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Chapter 63

Total Artificial Heart

O. H. Frazier/ Nyma A. Shah/ Timothy J. Myers

EARLY DEVELOPMENT AND EXPERIENCE
FIRST TOTAL ARTIFICIAL HEART
AKUTSU-III TOTAL ARTIFICIAL HEART
JARVIK-7 TOTAL ARTIFICIAL HEART
ABIOCOR TOTAL ARTIFICIAL HEART
COMPLICATIONS
COMMENT

?? INTRODUCTION
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Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States and a significant public health problem in most industrialized nations. Since 1900, CVD has been the leading cause of death in the United States every year except 1918.1 In 1999, it caused 958,775 American deaths. At the same time, the number of people with CVD, especially its advanced forms, is increasing. There are several reasons for this. First, while there is still no cure for CVD, palliative therapy has improved to the point that more people are surviving past their initial episodes of CVD to live on with some form of the disease. Second, the average age of the U.S. population is rising as the "baby boom" generation ages.

An increasingly prevalent form of advanced CVD is congestive heart failure (CHF). Today, almost 4.8 million Americans (approximately 2.3 million men and 2.4 million women) are living with CHF.2 Its etiology can be ischemic, idiopathic, or viral. More than $36 billion is spent each year on the care of CHF patients, and many therapeutic advances have been made. Nevertheless, between 1979 and 1999, the incidence of CHF increased by 145%. Each year, CHF directly causes 30,000 to 40,000 deaths and indirectly contributes to another 250,000. Large as the problem is now, its magnitude is expected to worsen as more cardiac patients are able to survive and live longer with their disease and thus increase their chances of developing end-stage CHF.

At present, treatment of advanced CHF takes three forms: medical therapy, surgical therapy, and cardiac replacement.3 Medical therapy (e.g., intravenous inotropes and vasodilators) relieves symptoms by reducing cardiac load and increasing myocardial contractility. However, while advances in medical therapy have helped improve quality of life for those with heart failure, mortality remains unaffected. Surgical therapy (e.g., aortocoronary bypass, transmyocardial laser revascularization, valve replacement or repair) relieves symptoms of ischemia and valvular dysfunction, but in most cases does not stop the underlying disease process from progressing until death. When conventional medical and surgical therapies for CHF are exhausted, cardiac replacement (i.e., heart transplantation or implantation of an artificial heart) may in some cases become the only therapeutic alternative.

Heart transplantation has evolved into a suitable treatment for advanced CHF. However, it has severe limitations related to patient selection, organ procurement and distribution, and cost-effectiveness. About 2500 patients with end-stage heart failure receive heart transplants each year in the United States. However, about 4000 patients are on the active heart transplant waiting list at any given time, and as many as 40,000 more are potential candidates for heart transplantation.4,5 Heart transplantation for the relatively young (because the life expectancy of a donor heart recipient is about 10 years on average and 20 years at most. In 2001, 458 patients on the active waiting list died while awaiting a donor heart. Heart transplantation is also associated with continuous, lifelong, expensive medical therapy.

To help overcome these limitations, engineers and physicians have continued efforts begun over 4 decades ago to develop systems for providing either temporary or permanent mechanical circulatory support (MCS). Originally, such systems were intended to support patients indefinitely because other forms of heart replacement did not appear to be feasible. Temporary MCS has been shown to be a suitable option for some CHF patients who are awaiting heart transplants6,7 and for others who are not transplant candidates but need support for indefinite periods of time.8 In recent clinical studies, myocardial function improved sufficiently in some cases to allow removal of the MCS device and avoid heart transplantation.9,10 Nevertheless, in light of the shortcomings of medical therapy, surgical therapy, and heart transplantation, efforts have continued to develop a total artificial heart (TAH) that would not only save the lives of critically ill CHF patients but also allow them to resume relatively normal lifestyles. Here, we review the historical development and current status of TAH technology.


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In 1812, LeGallois first proposed the idea of supporting a failing heart with either a permanent or temporary device.11 In the 1930s, Lindbergh and Carrel discussed and planned an artificial heart.12 Throughout the 1940s, researchers including Dennis and Gibbon were developing a machine that would bypass the circulation of the heart and lungs to allow open heart surgery. The modern era of MCS began in 1951 when Dennis first used a heart-lung machine to sustain the circulation while the heart was opened to repair an atrial septal defect.13 Two years later, Gibbon repeated this procedure.14 However, high mortality in the first few cases led both Dennis and Gibbon to abandon the use of their heart-lung machines. In 1954, Lillehei began to use cross-circulation (human-to-human perfusion) as a means to support heart and lung function during congenital heart defect repair.15 However, because of the controversy engendered by Lillehei's procedure in using human donors and putting two individuals at risk of death, researchers continued efforts to develop a machine that would allow open heart surgery.

By 1955, Kirklin at the Mayo Clinic had refined the Mayo-Gibbon machine and the techniques that allowed open heart surgery.16 Likewise, DeWall and Lillehei had developed their machine that also allowed for safe open heart operations.17 By 1960, Kirklin and Lillehei in Minneapolis and DeBakey and Cooley in Houston had perfected their machines and techniques to the point where heart surgery was becoming routine in Minnesota and Texas. The early developmental work on the use of mechanical circulatory systems by Dennis, Lillehei, DeWall, Gibbon, and Kirklin allowed for many new cardiac operations, including coronary artery bypass, heart transplantation, valve repair, and implantation of the total artificial heart. After refinements of the heart-lung machines, Debakey and Cooley began to develop many of the surgical techniques that eventually made open heart surgery routine around the world.

In 1957, Akutsu and Kolff became the first to implant a TAH in vivo.18 Inserted into the chest of a dog, the pump adequately maintained the circulation for approximately 90 minutes. However, Akutsu and Kolff never applied their TAH technology clinically. In 1964, the National Heart Institute established the Artificial Heart Program to promote the development of the TAH and other cardiac assist devices. In the early 1960s, DeBakey and researchers at Baylor College of Medicine in Houston began developing a TAH. In 1963, DeBakey implanted the first clinical left ventricular assist device (LVAD) into a 42-year-old patient.19 The pump functioned well, but the patient died of pulmonary complications after 4 days of support. In 1967, DeBakey implanted an LVAD into a 37-year-old who presented with symptoms of CHF including easy fatigability and severe dyspnea on slight exertion. This patient also had history of rheumatic heart disease since age 18 and closed mitral valvulotomy at age 25. The intention was to use the LVAD until sufficient myocardial recovery could be gained. The LVAD supported the patient's circulation for 10 days and was then electively removed. The patient was discharged from the hospital on postoperative day 29 and later resumed normal activity. On follow-up at 18 months after LVAD removal, the patient remained free of CHF symptoms, and a chest x-ray showed a significant reduction in cardiac size.


?? FIRST TOTAL ARTIFICIAL HEART
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The first implantation of a TAH into a human was done by Cooley on April 4, 1969, in a 47-year-old man who could not be weaned from cardiopulmonary bypass (CPB) following left ventricular aneurysmectomy.20 The intent was to support the patient until a donor heart could be found. The TAH (Fig. 63-1), designed by Liotta, was a pneumatically powered, double-chambered pump with Dacron-lined right and left inflow cuffs and outflow grafts. Wada-Cutter hingeless valves controlled the direction of blood flow through the pump. The TAH itself was connected to a large external power unit, which unfortunately severely restricted patient mobility. The TAH performed adequately for 64 hours until transplantation. The donor heart also functioned well, but the patient died of pseudomonal pneumonia 32 hours after transplantation. Though the Liotta device performed as designed, it was never used clinically again. Nevertheless, this case clearly demonstrated that a TAH could be safely and effectively used in a human as a bridge to transplantation.



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FIGURE 63-1 The Liotta total artificial heart, the first TAH implanted in a human.

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?? AKUTSU-III TOTAL ARTIFICIAL HEART
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The second implantation of a TAH in a human was also done by Cooley. On July 23, 1981, Cooley implanted the Akutsu-III TAH into a critically ill 26-year-old man who suffered heart failure after undergoing coronary artery bypass surgery for severe arteriosclerosis. Unable to be weaned from CPB after surgery, the patient was fitted with the TAH in a final effort to sustain his life. The Akutsu-III TAH (Fig. 63-2) consisted of two pneumatically powered, double-chambered pumps featuring reciprocating hemispherical diaphragms.21 CPB was discontinued 90 minutes after implantation. The TAH provided excellent hemodynamics and supported the patient in stable condition for a total of 55 hours until a suitable donor heart was found. The patient finally received a transplant but died of infectious, renal, and pulmonary complications 10 days later. Despite the fatal outcome, this case demonstrated that the TAH could adequately sustain a patient for several days, with no evidence of hemolysis or thromboembolism, until heart transplantation.



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FIGURE 63-2 The Akutsu-III total artificial heart, the second TAH implanted in a human.

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?? JARVIK-7 TOTAL ARTIFICIAL HEART
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In the late 1970s, Kolff and his team at the University of Utah developed the Jarvik-7 TAH. In 1982, DeVries became the first to permanently implant a TAH when he implanted a Jarvik-7 into a dying patient.22 The Jarvik-7 TAH (Fig. 63-3) was a pneumatically powered, biventricular pulsatile device that replaced the heart.23,24 The pumps were connected to their respective native atria by synthetic cuffs and connectors. Each pump had chambers for air and blood separated by a smooth flexible polyurethane diaphragm. The inflow and outflow conduits contained Medtronic-Hall tilting disk valves. The filling of the pumps was aided by vacuum. Pneumatic drivelines, brought out through the chest wall to connect with an external console, shuttled air to the pumps during systole, thereby causing collapse of the pump sac and blood ejection. Pump rate, drive pressure, and systolic duration were monitored and optimized from the external console. The Jarvik-7 had a stroke volume of 70 mL and a normal cardiac output of 6 to 8 L/min (maximum, 15 L/min).



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FIGURE 63-3 The CardioWest total artificial heart (CardioWest Technologies Inc., Tucson, AZ), formerly the Jarvik-7 and Symbion TAH.

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In the initial clinical experience with the Jarvik-7 TAH, a total of 5 patients were permanently supported for periods ranging from 10 days to 620 days. The TAH was able to adequately support circulation, but its large drive console and frequent medical complications limited patient activity. Four patients were able to make brief trips out of the hospital and to see family and friends. Long-term outcomes, however, were poor. Patients supported by the Jarvik-7 for longer periods suffered several complications, including thromboembolism, stroke, infection, and multiorgan failure.

Despite these mixed results, in 1985 the Jarvik-7 (renamed the Symbion) TAH entered clinical trials as a bridge to transplantation. In 1986, Copeland reported the first successful use of this device for this indication.25 Between 1985 and 1991, approximately 170 patients were supported with the Symbion TAH as a bridge to transplantation.26 Sixty-six percent underwent successful heart transplantation, a rate similar to those in bridge-to-transplantation studies of left ventricular assist devices. Sepsis and multiorgan failure were the primary causes of death during TAH support.

Although the bridge-to-transplantation study demonstrated that the Jarvik-7 (Symbion) TAH was clinically effective, the U.S. Food and Drug Administration withdrew the device's investigational device exemption (IDE) for clinical use in January 1991 because of inadequate compliance with FDA regulations.27 In January 1993, the IDE was restored to what was now called the CardioWest TAH, which differed little from the original Jarvik-7. The CardioWest TAH has since been used successfully in the United States, Canada, and France. Worldwide, 63% of CardioWest-supported patients eventually undergo successful heart transplantation and 92% of those are eventually discharged to home. In the United States, the rates are even better (93% and 96%, respectively).


?? ABIOCOR TOTAL ARTIFICIAL HEART
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On July 2, 2001, as part of an FDA-sponsored clinical trial, surgeons at Jewish Hospital in Louisville, Kentucky, performed the first implantation of the AbioCor TAH in a 59-year-old man suffering from end-stage CHF.28 The AbioCor totally implantable replacement heart is a self-contained electrohydraulic TAH (Fig. 63-4) that has been developed and tested by ABIOMED, Inc. (Danvers, MA) and the Texas Heart Institute, with the support of the National Heart, Lung, and Blood Institute (NHLBI).29,30 It is designed to sustain the circulation and extend the lives of patients with end-stage heart failure who have suffered irreversible left and right ventricular failure, for whom surgery or medical therapy is inadequate, and who would otherwise soon die (Table 63-1). The AbioCor is the first TAH to be used clinically that is fully implantable and communicates to external hardware without penetrating the skin. The device utilizes a transcutaneous energy transfer (TET) system and a radiofrequency communication (RF Comm) system that allows it to be powered and controlled by signals transmitted across intact skin. A unique feature of the AbioCor is a right-left flow balancing mechanism that eliminates the need for an external vent or internal compliance chamber.31



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FIGURE 63-4 The AbioCor total artifical heart (ABIOMED, Inc., Danvers, MA).

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TABLE 63-1 Inclusion/exclusion criteria for FDA-sponsored clinical trial of AbioCor total artificial heart

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The internal components of the AbioCor system consist of a thoracic unit, internal TET coil, controller, and battery.32 The thoracic unit (pump) weighs about 2 pounds and consists of 2 artificial ventricles, 4 valves, and an innovative motor-driven hydraulic pumping system (Fig. 63-5). The pump's motor rotates at 6000 to 8000 rpm, which allows sufficient hydraulic fluid pressure to compress the diaphragm around the blood chamber and eject blood. A miniaturized electronics package implanted in the patient's abdomen monitors and controls the pump rate, right-left balance, and motor speed. An internal rechargeable battery, also implanted within the abdomen, provides emergency or backup power. The internal battery is continually recharged via the TET system and can provide up to 30 minutes of tether-free operation.



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FIGURE 63-5 The AbioCor system is designed to increase or decrease its pump rate in response to the body's needs. The AbioCor also includes an active monitoring system that provides detailed performance feedback and alarms in the event of irregularities.

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The AbioCor's external components include a computer console, an external TET coil, and external battery packs. The external computer communicates via the RF Comm system with the abdominally implanted controller, which controls the pump. The external TET coil provides power to the pump from the console or from the external battery packs. The external battery packs can power the AbioCor TAH for 2 to 4 hours.

Since its first implantation, the AbioCor has been implanted 6 more times at several institutions (Table 63-2). As of this writing, 1 patients continues to be supported at 474 days. Four of the 6 patients survived beyond the 60-day study end point, which is twice their predicted life expectancy. Four patients became ambulatory and were able to leave the hospital for short periods. Quality of life improved in 4 patients.


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TABLE 63-2 Summary of initial clinical experience with AbioCor total artificial heart*

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?? COMPLICATIONS
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Use of a TAH is associated with serious complications. The most frequent complications are infection, severe postoperative bleeding, and thromboembolism.3336 Potentially serious but less frequent complications are renal, hepatic, pulmonary, and neurologic dysfunction, and complications due to technical problems.33,37 Complicating factors include patient selection, device size, implantation timing and location, the need for extensive surgery at implantation, and the reliability of support equipment.

Life-threatening infections have been the most important complication for patients being supported permanently by a TAH.38 In the Jarvik-7 experience, all patients supported for many months developed serious infections that eventually contributed to their deaths.22,39 Patients supported by a TAH for shorter periods while awaiting heart transplantation had infection rates of 30% to 40%.3438 During the 1980s, driveline and mediastinal infections in TAH-supported patients were frequent and severe, regardless of the duration of support. However, in the more recent bridge-to-transplantation experience with the CardioWest TAH, the infection rate was no more than 20%.40,41

Patients supported with a TAH, regardless of the intended use, are very susceptible to infection. Predisposing factors include the tissue trauma of the surgery; contamination of the implanted device; depressed immune defenses; a large foreign material surface area; and use of the drivelines, tubes, catheters, and other devices that are necessary for the care of these patients. Infections can occur at any point during TAH support. Once an internal component of the TAH system is infectiously colonized, treatment is difficult and often ineffective. Infections are more likely to occur in the early postoperative period, especially in the most critically ill patients, due to device contamination during the course of their care and to postoperative bleeding resulting from intensive care procedures and exposure during reoperation. Meticulous care and numerous infection prevention measures are vital in all TAH patients.

Postoperative bleeding is a frequent and serious complication of TAH implantation. It generally occurs in 40% to 50% of TAH or ventricular assist device recipients.33 In the more recent CardioWest experience, the rate was approximately 25%. Contributing factors include severe CHF and associated hepatic dysfunction, the extensive surgery and lengthy CPB time required for implantation, and the necessity for postoperative anticoagulation therapy. Severe CHF often leads to hepatic dysfunction and subsequent derangement of the coagulation system. Patients with severe CHF are often receiving continuous preoperative anticoagulant or antiplatelet therapy, the effects of which are often difficult to reverse before TAH implantation. The extensive surgery and lengthy CPB time required for implantation can lead to severe depletion of clotting factors. The necessity for postoperative anticoagulation therapy requires that a proper balance be established between preventing thrombosis and allowing blood to clot, through the careful management of hemostasis and anticoagulant therapy.

Thrombosis within the TAH is of particular concern. Five of the first 6 Jarvik-7 recipients suffered thromboembolic events. However, the frequency of thromboembolism has decreased significantly since that initial experience and is now an estimated 10% to 15%.33,34,42 Preventive measures are primarily targeted at precisely monitoring the thrombotic and fibrinolytic systems, maintaining sufficient flow through the device to avoid stasis, and providing adequate anticoagulation and antiplatelet therapy. Generally, heparin and warfarin are used as antithrombotic therapy to achieve a prothrombin time, activated thromboplastin time, or international normalized ratio 2 to 3 times greater than the baseline or normal value. Aspirin or dipyridamole or both are also used.

There is a complex though poorly understood interrelationship between infection, bleeding, and thromboembolism. Thrombus formation may lead to the development of infection, and bacterial colonization may lead to thrombus formation. Bacteria are often seen in thrombi found in cardiovascular devices.43 Bacteria embedded in a thrombus are protected from circulating antibiotics and leukocytes. Bacteria, endotoxins, and inflammatory cells may contribute to thrombus formation by their effect on platelet aggregation.44 Bacterial endotoxins can cause platelet aggregation, endothelial injury, and increased endothelial thromboplastin activity. Excessive bleeding most often results in reoperation, which increases the patient's exposure to contamination. Also, blood transfusions and intravascular monitoring for these critically ill patients are more extensive and result in frequent exposure to the external environment. Infection, bleeding, and thromboembolism can contribute individually and collectively to the development of multiorgan failure, one of the most frequent causes of death in TAH recipients.

Other important problems and issues related to TAH implantation are device malfunction, poor fit or size mismatch between TAH and patient, social and ethical issues, mobility, and nutrition. Device malfunction leading to cata-strophic failure of the TAH or ventricular assist device is rare. Most technical issues have involved external components and have been readily resolved. Fit and size mismatch remain a problem. All TAH models used to date have been relatively large and only fit adequately into patients with a body surface area greater than 1.7 m2. Because the cost of TAH technology is fairly high and most candidates for TAH implantation are in their sixth to seventh decade of life, many question whether society should bear the cost of developing this technology. Until recently, the external components of the TAH equipment have been large and cumbersome, thus limiting patient mobility, exercise, and rehabilitation. More recent designs of the TAH allow for much more mobility.


?? COMMENT
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Since the 1950s, when the heart-lung bypass machine was developed, many advances have been made in the surgical treatment of CVD. Many surgical procedures considered impossible just 40 years ago are today considered routine. A classic example is heart transplantation. However, TAH technology has not evolved at the same pace. Though the first human heart transplantation and first human TAH implantation occurred within 2 years of each other, TAH implantation is still neither routine nor widely available. However, two TAHs are undergoing clinical trials at present in the United States. The CardioWest (formerly the Jarvik-7) TAH is more widely used but still has not yet received FDA market approval, though it may be approved for use as a bridge to transplantation in the near future. The AbioCor TAH is still in the early stages of its FDA-sponsored feasibility study and is likely years away from approval as an alternative to heart transplantation. However, should its unique TET system and flow-balancing mechanism prove to be reliable for extended periods of time, the AbioCor may become a widely used alternative to heart transplantation for those patients who have no other treatment options.

There are many obstacles to overcome before any TAH is widely accepted. Infection, bleeding, thromboembolism, and biocompatibility issues are serious problems that affect nearly all implantable cardiovascular devices including TAHs. Improved biomaterials, better prevention, and more effective antibiotic and anticoagulant medications may help overcome these problems. Acceptance by the public, by some critics in the health professions, and by third-party payers may be slow. Quality in manufacturing is needed to ensure reliability of TAH components. Addressing these problems will help bring the TAH more quickly into routine clinical use.


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