Orthotopic transplantation after implantation of a Jarvik 7 total artificial heart.

A total artificial heart was used to support the circulation in 33 heart transplantation candidates who were expected to die before procurement of a donor heart. Twelve of these patients (mean age 35 +/- 10 years) underwent cardiac transplantation. Another patient is still being supported with the total artificial heart 90 days after implantation. The other 20 patients died during mechanical support because their condition could not be stabilized for transplantation, despite blood flow restoration. Fifty-six percent of the patients younger than 40 years underwent successful transplantation and six of nine patients are long-term survivors. By comparison, in the older group, 17.6% of patients underwent transplantation and one of three survived long term. Forty-four percent of patients in the acute decompensation group had successful transplantation and four of seven patients are long-term survivors. In the chronic decompensation group these figures were 29.4% and three of five patients. All patients who were heavily immunosuppressed (n = 4) died of sepsis. Transplantation was considered and performed only when the patient's condition was correct and stable. In six patients an infection developed in the immediate posttransplant period. Three of the infections were resolved with antibiotic therapy. One originated in the mediastinum and is still unresolved, although the patient's condition is improving. Another patient died of an anoxic coma caused by ventilatory problems. There were two late deaths at 14 and 19 months, one resulting from a combination of toxoplasmosis and rejection and the other from a Kaposi sarcoma caused by azathioprine treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

The artificial heart. Progress and promise.

A multidisciplinary group has designed, fabricated, and evaluated an artificial heart. The heart consists of two smooth-surfaced sac-type pumps, two pneumatic power units, and an electronic control system. The artificial heart has been employed in 22 calves. A variety of problems have been encountered and overcome and a significant improvement in pump design has been made. As a result, a gradual increase in survival times has occurred. The last two calves in which the heart was tested lived for 60 and 42 days respectively. These animals ate well and gained weight. The ability of the control system to balance the output of the two pumps over long periods of time and to automatically increase cardiac output with treadmill exercise has been confirmed. No insurmountable problems in the development of the artificial heart have been identified. The date that an artificial heart will be available for clinical use depends on the availability of funds and on the tenacity of the investigators.

Total artificial heart: survival and complications.

A total artificial heart was implanted in 28 patients as a bridge to transplantation. Mean time of mechanical support was 14.8 +/- 10 days. The 70-mL Jarvik-7 was used in 12 patients and the 100-mL Jarvik-7 in the remaining 16. No clinical thromboembolic complications occurred during implantation. There was no postoperative bleeding requiring operation. Both survival and the rate of complications were similar in the two Jarvik-7 groups. Eleven patients underwent successful transplantation, and 1 patient is still on mechanical support. Sepsis and multiple-organ failure were the most important causes of death. All patients receiving the total artificial heart for severe acute rejection after transplantation died of infection. Early implantation of the total artificial heart is advised in younger patients and in older patients with acute cardiac failure. The use of this device should be contraindicated in immunosuppressed patients because of the high risk of infection.

Can we obtain one year survival of total artificial heart(TAH) animal?

A TAH goat survived 344 days postoperatively. The cause of death was hypoxia due to lung embolism and anemia.

Determinants of pannus formation in long-surviving artificial heart calves, and its prevention.

In a group of 76 calves maintained with Jarvik-5 and Jarvik-7 artificial hearts, pannus formation in the atrial location was evaluated retrospectively using a grading system based on measurement of the pannus tissue. Pannus was present in 87% of the calves surviving one to 7 mos with an old-style inflow quick-connect design utilizing polyester felt surfaces. This design had a suboptimal hemodynamic flow path. Using a new design of quick-connect with an improved hemodynamic flow path and a Biomer blood-contacting surface, pannus occurred only in 17% of calves surviving one to 9 mos. Furthermore, the pannus formation with the new design was mild in the 2 cases where it occurred, whereas the pannus formation in animals with the old cuffs was frequently severe. One calf survived 9 mos with no pannus formation utilizing our new quick-connect system, and we conclude that pannus is no longer a problem in our experiments. We also reviewed the relation of pannus to anticoagulant regimens and found that Persantine, Coumadin, and aspirin were not effective in preventing pannus when the inflow cuff design was conducive to its development.

Surgical positioning of the Jarvik-7 artificial heart.

The Jarvik-7 total artificial heart has been implanted in 18 patients at the time of this writing. Eleven patients received the 100 ml heart, and the remaining seven were treated with the 70 ml device. To date, five patients have been implanted for permanent use with an average survival in excess of 9 months, and the longest survival is more than 1 1/2 years following implantation of the heart. Complications related to positioning were a contributing factor in the death of one patient. Thirteen patients have received the Jarvik-7 heart as a bridge to transplant. Three died before transplant, and the remaining ten have been transplanted. To date, all are alive, several are home and in excellent condition, and several are still hospitalized but are expected to be released shortly. Three patients have experienced serious complications after transplantation. One patient rejected her heart transplant, was reimplanted with the artificial heart, and now has been sustained for more than 3 months. At this time she is in good condition awaiting a second donor. Selection of the appropriate size Jarvik-7 artificial heart for the individual patient can best be made based on measurements of thoracic dimensions obtained from a computed tomography scan and calculation of body surface area. The appropriate medial or lateral positioning can be determined and decisions concerning the lengths of the grafts and cuffs, excision or nonexcision of the left pericardium, and air drive line position can be made. The Jarvik-7 heart can be successfully used in patients from 50 kg. However, at the lower size limit in patients from approximately 50 to 65 kg, the risk of fit complications is the greatest and availability of an even smaller model heart would be desirable.

Temporary use of the Jarvik-7 total artificial heart before transplantation.

Between October 24, 1985, and July 31, 1986, the Jarvik-7 total artificial heart was implanted into six moribund patients in an attempt to test its potential as a bridge from almost certain death to cardiac transplantation. Four of these patients are now well and at home after implantation of the device and subsequent cardiac transplantation. Before transplantation, one patient died with sepsis and multiorgan failure that preceded implantation of the artificial heart. Another patient died with acute rejection 60 days after cardiac transplantation. Fifty-two days of total mechanical support with the artificial heart were accumulated in these six patients, and although the device worked flawlessly and no clinically apparent thromboembolic events occurred, each artificial heart contained areas of macroscopic aggregations of platelets and thrombi. The results of this trial indicate that in properly selected cases, direct benefit to the patient can be obtained when the Jarvik-7 artificial heart is used as a bridge to transplantation.

Experimental studies in total artificial heart replacement.

Twenty-seven calves were operated on in our institute for total artificial heart replacement. Thomasu hearts (made by the Thomasu Technical Company, Japan) were used in 21 calves from February 1980 to May 1983. Utah Jarvik 7 hearts were used for the first five calves and the 17th calf. The air-driven Thomasu heart, made of segmented polyurethane, has 95 ml and 85 ml of stroke volume in its left and right sides respectively and showed recognizable function curves in mock circulation systems. There were no satisfactory results in the first 19 cases but the 20th calf survived for 28 days. In 1982, we adopted a new surgical method in which, instead of suturing, a sutureless artificial graft with a stainless steel ring was inserted into the aorta and pulmonary truncus. Since then two out of six calves have survived for more than one month; one of these survived for 66 days. The causes of death after the Thomasu heart replacements were varied. Ten (48%) out of 21 cases had heart trouble and four calves (19%) died through thrombus formation at the inflow and outflow valves. Three calves (14%) died because of mechanical failure of the driving system, two (10%) due to surgical failure, one because of pneumonia, and one due to an abnormal reaction after donor blood transfusion. Our longest surviving calf died after 66 days, because of a broken left blood diaphram though, it remained in excellent condition until its death. There was no thrombus formation in either ventricle, no fibrin net formation and no calcium deposit on the surface of the diaphragm.(ABSTRACT TRUNCATED AT 250 WORDS)

Cumulative clinical experience with the Symbion J7 TAH.

As of March 1, 1988, 92 patients have received the Symbion J7 pneumatic TAH as a bridge to cardiac transplantation. All implantee's were Category 6 (Urgent Need) patients, exhibiting functional Class IV symptoms or facing imminent death, in the judgment of their physician prior to obtaining a suitable cardiac allograft. Sixty-three of these patients, (68%) were transplanted. Of the 56 transplants 35 (56%) patients are currently alive, with most returning home and back to work. Implant duration ranged from 1 to 243 days of support, with an average of 24 days. Implantee average age was 42 years, with a range of 15-60 years. Male/female distribution was 80/12, with the females requiring longer periods of pump support and exhibiting lower survival rates. Several main implant categories have surfaced during the study, with the collective disease category of cardiomyopathy constituting 66% of the study population. This broad category may be subdivided into ischemic cardiomyopathy 52%, idiopathic 25%, viral 7%, and miscellaneous 16%. Acute rejection of donor organ (17%) and unweanable patients (11%) constitute the other major implant categories. Postoperative complications observed in a population cohort of 70 patients include bleeding in 44%, infection in 34%, reoperation in 27%, neurologic dysfunction in 13%, and device failure in none. Standardized device explant analysis results indicate a trend in thrombus reduction concurrent with increased investigator experience and improved patient management techniques. The concept of bridging in a specific group of patients in which the prognosis is otherwise hopeless continues to demonstrate therapeutic value.

Pathological studies of the animals replaced totally with the artificial heart. Part II Concerning liver, gastrointestinal tract, kidney, and general discussion.

Twenty-eight goats with an artificial heart (AH) were studied pathologically. Being continued from the previous report, the liver, gastrointestinal tract, and kidneys were taken up in this paper and finally, general discussion was done to get our ideas in shape concerning the pathophysiological status of the goat. Central necrosis of the liver was always observed in the goats which survived for over 140 hours. This finding seemed to be caused mainly by circulatory insufficiency of the portal vein at the latter half of the survival time. Microscopic findings of degeneration, necrosis, and edema were commonly observed at the walls of gastrointestinal tracts, when goats showed poor apetite, mucous feces and constipation. But these problems have been improved by application of a new control method to regulate the output of AH system within a goat's physiological range since October 1974. The lesions seen in the kidneys are classified into 5 groups. The most important findings of them are lower nephron nephrosis and cortical necrosis, both of which indicate the occurrence of long standing vasoconstriction of proximal renal arteries. By means of microangiographic method and others, thrombi were detected frequently in the kidneys. The vascular walls, where thrombi were attached to, were often damaged. Therefore, these thrombi were thought to be formed in the local vessels in situ through renal circulatory insufficiency. The renal pathological lesions have been also improved and severe renal failure from which the previous goats could not escape, has been lessened since the application of a new AH control method. As a whole, the main pathophysiological status of the animals replaced by the AH are thought conclusively to be peripheral circulatory insufficiency. This would be caused by abnormal hemodynamics, so that, the essential clinical etiology is thought to be AH function itself.