Initial United Kingdom experience with the syncardia total artificial heart
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Implantable prosthetic ventricles and trileaflet valves made by vacuum forming have been developed and implant tested. All components are made from Pellethane ® . Recognizing the need for smaller as well as larger ventricles, designs with effective stroke volumes of 50, 85, 100 and 130 cc have been tested with several valve types. The pneumatically driven Utah ventricular assist device (UVAD) can be used as a total artificial heart (TAH) or ventricular assist device (VAD) by using the appropriate inflow and outflow adapters. In vitro durability testing has demonstrated ventricular lifetime beyond two years and valve lifetime to nearly one and one half years. The polymer valves have lower regurgitation than mechanical valves. Animal implantation experience includes 21 TAH implants and 16 left ventricular assist device (LVAD) implantations. TAH survival ranges from 2 to 210 days. LVAD animals have lived up to 116 days before elective termination. The animal were healthy and grew normally. The devices exhibit a “Starling's Law” response. One TAH animal survived 72 days before successful explantation followed by transplantation. At autopsy, this animal had no renal infarcts. Hematology data has demonstrated the existence of little or no intravascular hemolysis (PF Hb < 5 mg%). The “Philadelphia” version of the UVAD vacuum formed ventricles are small enough to be implanted without thrombus provoking connectors. Eight animals have received this TAH and survived up to 120 days. Vacuum forming offers a rapid and inexpensive way to produce reliable and effective total artificial hearts and valves for widespread, temporary clinical application in any size adult human.
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There has been a quest for an artificial organ that can replace the heart for decades. Remarkable advances were made in the second half of the twentieth century in the fields of medicine and engineering that led to the development of several devices with the intention of totally replacing the human heart. Some of these devices, like the Jarvik artificial heart, were utilized initially as a permanent replacement for the failing heart. It became more successful as a bridge to heart transplantation (BTT) in the years that followed its introduction. Currently the CardioWest total artificial heart (TAH) is the only device in clinical use with the intention of bridging patients to heart transplantation. Two new TAHs are being developed with the intention of being used as an alternative to transplantation (ATT) or on a permanent basis. The next 100 years will bring revolutionary new designs and advances in the field of end stage heart disease that may only be ideas at the present time.
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634 Terminally ill heart failure patients awaiting heart transplantation (HT) who require mechanical circulatory assistance for survival may have right ventricular function that is too poor to permit isolated left ventricular assist device therapy. In our institution, between July 1, 1994 to December 31, 1996 we used the Cardiowest total artificial heart on such patients who eventually received a heart transplant (Group I). We compared these patients to other patients awaiting HT, who were not as ill prior to HT, who were successfully transplanted without need for any other circulatory assist device(Group II). TableConclusions: In patients fortunate enough to received eventual HT, the use of Cardiowest total artificial heart is a very effective bridge to HT, despite the high hospital charges associated with additional surgery and longer hospitalization.
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Abstract Background Heart failure hospitalizations in adult patients with congenital heart disease (ACHD) are increasing and are associated with higher healthcare-related costs. We aimed to evaluate factors that are associated with repeated heart failure hospitalizations and whether heart failure hospitalizations are related to adverse outcome in ACHD patients with heart failure (ACHD-HF). Methods Out of 3995 patients under active follow-up in our institution (last visit >2010), 256 patients (mean age 49.5±16.7 years) had ACHD-HF and were included in the study. Medical records were reviewed, including heart failure hospitalization prior and after study inclusion. A combined endpoint of death, ventricular assist device and transplantation was defined. Results Overall, 136 ACHD-HF patients (53%) had a prior heart failure hospitalization. Over a mean follow-up of 2.5±2.3 years, 44 patients (17%) had repeated heart failure hospitalizations. Of these, 31 patients (12%) had 1; 9 patients (4%) 2 and 4 patients (2%) 3 repeated heart failure hospitalizations. Patients with repeated heart failure hospitalizations had higher NYHA class (p=0.031), were more likely to have end-organ dysfunction (p=0.025) and more likely to have a prior heart failure hospitalization (p<0.001). In multivariable Cox regression analysis, only end-organ dysfunction (HR 2.431 95% CI 1.516–43.896 p<0.001) was related to repeated hospitalization. Seventy patients (27%) reached the combined endpoint of death, VAD or transplantation (event-rate 11% per year). Repeated heart failure hospitalizations was not related to the combined endpoint in Cox regression analysis. Conclusions Heart failure hospitalizations are frequent in ACHD-HF. End-organ dysfunction appears to be a strong determinant of repeated heart failure hospitalizations. Event-rate is high in patients with ACHD-HF, but repeated heart failure hospitalizations were not related to outcome in this short-term follow-up study. Funding Acknowledgement Type of funding sources: None. Table 1.1Table 1.2
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634 Terminally ill heart failure patients awaiting heart transplantation (HT) who require mechanical circulatory assistance for survival may have right ventricular function that is too poor to permit isolated left ventricular assist device therapy. In our institution, between July 1, 1994 to December 31, 1996 we used the Cardiowest total artificial heart on such patients who eventually received a heart transplant (Group I). We compared these patients to other patients awaiting HT, who were not as ill prior to HT, who were successfully transplanted without need for any other circulatory assist device (Group II). TableConclusions: In patients fortunate enough to received eventual HT, the use of Cardiowest total artificial heart is a very effective bridge to HT, despite the high hospital charges associated with additional surgery and longer hospitalization. *p<0.01
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Mechanical circulatory support has been used to treat graft failure after heart transplantation, but in patients who needed mechanical circulatory support because of chronic rejection, we have suffered from the treatment because its outcome was catastrophic. Multiple organ failure was often caused by the addition of or increase in immunosuppressive medications, and it is known as a cause of the poor outcomes. The CardioWest total artificial heart was implanted for a case of chronic heart transplant rejection to enable complete withdrawal of immunosuppressive medication. The patient underwent re-heart transplantation, with a good result. This is a new therapeutic technique for chronic graft rejection. (Circ J 2009; 73: 1167-1168)
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Abstract: It became necessary to perform a staged procedure by means of total artificial heart followed by cardiac transplantation in a 26‐year‐old, female patient. The Ellipsoidheart, as an artificial heart, fitted excellently in the chest without compromising the surrounding structures. As soon as the patient recovered with the artificial heart, a consecutive transplantation was performed. This first European clinical experience gained confidence and suggests applying more artificial hearts as a bridge towards transplantation.
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An artificial heart is a continuous-flow pump device with a constant output, which usually supports the left ventricle. Over the past five years, survival rates with an artificial heart have increased dramatically, but with an annual mortality of 10% per year compared with 6% for heart transplantation the artificial heart is mainly a 'bridge to transplantation' or an alternative for those patients who are not suitable for heart transplant, 'destination therapy'. It is anticipated that the number and severity of complications will decrease as a result of technological progress. The artificial heart could then become a long-term treatment option providing a good quality of life and thus become equivalent to a heart transplant.
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