SynCardia Total Artificial Heart Research Articles

Total artificial hearts: an overview of post-implantation nursing care for recipients

Heart failure affects more than 750 000 people in the UK ( British Heart Foundation, 2014 ). For many years, heart transplantation has been the definitive end-stage treatment once medical therapy no longer provides adequate symptom management and acceptable quality of life for people experiencing heart failure. The scarcity of donor organs means heart transplantation is not always immediately available so, for those patients with biventricular failure, the options for improving quality and longevity of life are limited. However, an alternative is now available in the form of the total artificial heart (TAH). This article provides an understanding of the history and available models of the TAH, the recipient selection criteria and how TAHs actually function. As the only TAH currently commercially in use in the UK, Australia and the USA, the implantation and nursing care of the SynCardia TAH recipient in both the intensive care unit and ward setting will then be discussed, with consideration given to discharging patients home with a TAH in situ.

Mechanical Circulatory Support in Advanced Heart Failure: Single-Center Experience

BackgroundCurrently, ventricular assist device (VAD) or total artificial heart (TAH) mechanical support provides an effective treatment of unstable patients with advanced heart failure. We report our single-center experience with mechanical circulatory support therapy. MethodsFrom March 2002 to December 2012, 107 adult patients (mean age, 56.8 ± 9.9 y; range, 31–76 y) were primarly supported on temporary or long-term VAD or TAH support as treatment for refractory heart failure at our institution. Temporary extracorporeal radial VAD support (group A) was established in 49 patients (45.7%), and long-term paracorporeal and intracorporeal VAD or TAH (group B) in 58 patients (54.2%). Left ventricular (LVAD) support was established in 55 patients (51.4%; n = 33, Heartmate II; n = 6, Heartmate I XVE; n = 4, Heartware HVAD; and n = 12, Centrimag) and biventricular (BVAD/TAH) support (group B) in 28 patients (26.1%; n = 10, Thoratec paracorporeal; n = 2, Heartware HVAD, n = 1, Thoratec implantable; n = 1, Syncardia TAH; and n = 14, Centrimag). The temporary Centrimag was the only device adopted as isolated right ventricular (RVAD) support, and it was inserted in 24 patients (22.4%). ResultsIn group A, overall mean support time was 10.2 ± 6.6 days (range, 3–43 d). In group B, LVAD mean support time was 357 ± 352.3 days (range, 1–902 d) and BVAD/TAH support time was 98 ± 82.6 days (range, 8–832 d). In group A, the overall success rate was 55.1% (27 patients). In group B, LVAD overall success rate was 74.4% (32 patients) and BVAD/TAH success rate was 50% (7 patients). Overall heart transplantation rate for both groups was 27.1% (n = 2, group A; n = 27, group B). Overall 1-year and 5-year survivals after heart transplantation were 72.4% (n = 21) and 58.6% (n = 17), respectively. ConclusionsMechanical circulatory support is an effective strategy even in cases of end-stage heart failure according to our experience. Further improvement of VAD and TAH technologies may support their adoption as an encouraging alternative to heart transplantation in the near future.

A first step beyond traditional boundaries: destination therapy with the SynCardia total artificial heart

The SynCardia total artificial heart is currently used as a bridge to transplantation therapy in cases of irreversible, acute or chronic, biventricular heart failure. We describe the implementation of this technology in the context of destination therapy in a patient with an end-stage heart failure on grounds of primary amyloidosis.

Total artificial heart for bridge to cardiac transplantation: first patient at home in Turkey

Total artificial heart (TAH) is a mechanical circulatory support system used for keeping the patients with end-stage heart failure alive until cardiac transplantation. In this article, we aimed to present our experience with the first patient who was discharged from the hospital after TAH implantation and scheduled for cardiac transplantation in Turkey. A 45-year-old male patient who received medical therapy for dilated cardiomyopathy was implanted a TAH until an appropriate donor was found for cardiac transplantation due to severe biventricular heart failure and large body size of the patient. He was discharged from the hospital at 60 days postoperatively with the Freedom Driver and has been still waiting for an appropriate donor for cardiac transplantation for two years at home. SynCardia TAH is an effective and safe therapeutic system, providing a high cardiac output (~10 L/min), particularly in patients with a large body surface area and chest cavity. Freedom Driver also enables patients to live at home safely.

Veno-venous extracorporeal membrane oxygenation with a bicaval dual-lumen catheter in a SynCardia total artificial heart patient

We report the case of a 55 years old caucasian male patient with cardiogenic shock due to an extended myocardial infarction who underwent SynCardia Total Artificial Heart implantation and veno-venous extracorporeal membrane oxygenation with a bicaval dual-lumen cannula for the treatment of adult respiratory distress syndrome.

Results with an Anticoagulation Protocol in 99 SynCardia Total Artificial Heart Recipients

For 15 years, we employed a consistent anticoagulation protocol in 99 consecutive SynCardia Systems total artificial heart (TAH) recipients. Thromboelastography and platelet aggregation studies were used for evaluating and modulating therapy with dipyridamole, pentoxiphylline, aspirin, and heparin. Partial thromboplastin times, international normalized ratios, and platelet counts were also followed. After the second post-implant day in patients who were free of endo-device infection (97 patients), the embolic stroke incidence was 0.08 per patient year. This included 23.6 patient years of device support. There were no spontaneous hemorrhagic strokes. Two patients had endo-device infections and both had strokes. Postimplantation bleeding was seen in 20% of patients. All but two of these were within the first postoperative week. In all, 4% of patients had gastrointestinal bleeding. We did not observe heparin-induced thrombocytopenia in any patient. We conclude that stroke rates on TAH support have been low, and recommend this protocol.

Long Term Results with Total Artificial Heart: Is It Prime Time for Destination Therapy?

Purpose During recent years, mechanical circulatory support (MCS) devices have been increasingly used for long-term support. The Syncardia/CardioWest total artificial heart (TAH) has been implanted in over 1075 patients worldwide as a bridge to transplant. We reviewed data of patients supported more than one year to assess its safety and feasibility as destination therapy device. Methods and Materials 47 patients from 10 centers worldwide have been included in this retrospective study. Clinical data have been collected on survival, infections, thromboembolic and hemorrhagic events, device failure, antithrombotic therapy regimen and outcome. Results The median age was 49 years old, the median support time was 554 days (range 365 – 1373 days). The primary diagnosis was dilatative cardiomiopathy in 23 pts, Ischemic in 15 and other in 9. After at least one year of support patients have been successfully transplanted in 72% of cases, 24% died on device and 4 % are still supported. 4 patients (8%) had a device failure report but only for two patients it was the leading cause of death. Major complications were as follows: sistemic infections (19%; 3% leading death), drive line infections (20%, 0% leading death), ischemic (15%, 6% leading death) and hemorrhagic (23%, 6% leading death) events. Moreover antithrombotic regimen, hospital discharge, post operative rehabilitation period, drugs therapy and follow up management have been carefully investigated among our population of patience. Conclusions Cardiowest (t-TAH) has shown to be a reliable and effective device in replacing the entire heart. Device failure occurred rarely and only in two cases was the leading cause of death. The Syncardia TAH has emerged as a robust form of mechanical circulatory support for biventricular failure patients even in a setting of long term support. The dilemma of destination therapy is more ethical issue up to now considering the major impact in the quality of life of these patients.

The Worldwide Use of SynCardia Total Artificial Heart in Patients with Congenital Heart Disease

Purpose Over the past 3 decades, palliation of children with congenital heart disease (CHD) has been increasingly successful. This has created an ever-growing cohort of adolescents and young adults with congenital heart disease who unfortunately develop heart failure. Mechanically supporting such patients is possible, however, patients who have residual lesions or require multiple procedures (i.e. conduit exchange, valve repair) in order to place a ventricular assist device have a higher risk of morbidity and mortality. In complex patients, the use of the SynCardia total artificial heart (TAH) to avoid multiple procedures may be beneficial. However, the success of the TAH in the CHD cohort has not been reported. Methods and Materials All patients with congenital heart disease who had the SynCardia TAH implanted from 1986 to 2012 were identified in the Worldwide Syncardia TAH database, which contains 1091 patients. Results TAH was implanted in 24 patients with CHD (2.2% of total cohort). 25% (6/24) of the CHD patients were adolescents (12-18yo). These TAHs were implanted in 16 institutions around the world [US(9), EU(5) and Canada(2)]. Median age was 28 years [13- 56] and 25% were female. Total days of support were 1476 days with a median of 24 [1-359] days. Overall survival was 62% with a 100% survival in adolescents with CDH. Mortalities occurred in the 1st month of support in 89% (8/9) of cases. Cause of death was multisystem organ failure in 5, pulmonary hemorrhage in 1, not reported in 3. Competing outcomes analysis at 2 months demonstrates 67% of patients had a positive outcome: 34% were still on the TAH, 33% were transplanted, and 33% died. Conclusions Although a challenging cohort, the majority of these complex patients were successfully supported, particularly adolescents with congenital heart disease.

Comparative Analysis of von Willebrand Disease in Patients with Mechanical Circulatory Pulsatile and Non-Pulsatile Support

Purpose Aquired von Willebrand (vW) disease is induced by continuous flow ventricular assist devices (VAD) in patients under mechanical circulatory support (MCS). However, the influence of different MCS on the degradation of high molecular weight vW aggregates is less investigated. In addition the influence of intensive care therapy on vW-multimere analysis before MCS is not known. Methods and Materials We analysed the vW-antigene (vWA), ristocetin-(RCA) and collagen binding activity (CBA) and the vW multimers in patients supported by different MCS-systems: Thoratec biventricular VAD (THOB, n=30), Syncardia total artificial heart (TAH, n=40); LVADs: Thoratec (THOL, n=39), Novacor (NOV, n=37), Heartmate II (HM2, n=40) and Heartware (HW, n=38). vW-factor was analysed before and about 14 days after implantation. The data were compared to healthy blood donor controls (BDC). Results vWA, RCA and CBA was highly increased at the time of MCS-system implantation. Pulsatile LVADs and TAH had no influence on vWA, RCA and CBA during the observation period. BVAD-patients revealed significant reduction of CBA during MCS (p=0.0001). In contrast support with the axial flow HM2 was associated with reduced CBA (p Conclusions vW disease is prevalent in terminal heart failiure patients before MCS-system implantation. Continuous flow systems seem to have an increased effect on vW-factor activity compared to pulsatile devices. Centrifugal pumps may exert increased shear stress on blood components compared to other systems.

Low Rate of Allosensitization Associated with the Syncardia Total Artifical Heart and the Heartmate II LVAD

Purpose Significant rates of allosensitization have been associated with the use of durable mechanical circulatory support devices as a bridge to heart transplantation. Continuous flow devices have been demonstrated to have lower rates of allosensitization compared to older pulsatile devices. However, this is confounded by other factors such as the increased utilization of leuko-reduced blood transfusions. The aim of this study was to examine contemporary allosensitization rates in the Syncardia total artificial heart (TAH) and the Heartmate II LVAD (HMII). Methods and Materials A retrospective analysis of TAH and HMII implants performed at our institution between 10/2009 and 9/2012. During this time period, our blood bank switched to universal use of leuko-reduced blood products. Sensitization was defined by a cPRA > 10%. Sensitization following device implant was compared by Fisher’s exact test. Results Over the 3 year period, 42 TAH and 86 HMII implants were performed. PRA data post implantation was available for 36 TAH and 48 HMII implants. 7 (19%) TAH and 6 HMII (13%) were found to be sensitized following device implant (p=0.54). Of the 7 sensitized TAH patients, 5 were known to be sensitized prior to implantation. Of the 2 patients who developed sensitization following TAH implant, one was in the setting of a failed heart transplant. Of the 6 sensitized HMII patients, 2 were known to be sensitized prior to implantation. Baseline PRA data was unavailable for the other 4 patients. Of the 12 sensitized patients (one patient underwent both HMII and TAH implants), 4 have been transplanted, 2 died prior to transplantation, and 6 remain on device support. Conclusions Contemporary rates of allosensitization are lower than previously reported. Multiple factors affect allosensitization. Significant differences in allosensitization due to device type were not seen.

Efficacy of Genetic Profile Testing Using Allomap® in Combined Heart-Kidney Transplant Recipients

BackgroundThe recently published Image Trial in the New England Journal of Medicine noted the Allomap® test to have similar efficacy compared to invasive endomyocardial biopsy (RVBX) for immune surveillance of acute cellular rejection in low risk adult primary cardiac transplant recipients. However, the efficacy of Allomap® in combined heart kidney recipients is unknown.MethodsWe retrospectively evaluated 7 combined heart-kidney transplant recipients (6 males with 1 redo cardiac transplant recipient and 4 patients supported with Syncardia Total Artificial Heart). We performed protocol serial Allomap® testing at 3, 4, 6, 8 and 10 months post transplant as well as protocol RVBX's. As per our previously reported experience, we performed RVBx when Allomap® score ≥32.ResultsTabled 1Allomap Scores in Combined Heart-Kidney RecipientsValue3 Months4 Months6 Months8 Months10 MonthsAverage1027283638Standard Deviation1.278.82.61 Open table in a new tab InferencesOur findings suggest that combined heart-kidney recipients may in fact turn on or off key genetic factors giving rise to markedly elevated Allomap® scores. These elevated scores don't appear to be a signal for either acute cellular rejection or humoral rejection at the previously adjudicated values although our sample size is too small to say that with certainty. Clearly more needs to be done to clarify this intriguing observation. BackgroundThe recently published Image Trial in the New England Journal of Medicine noted the Allomap® test to have similar efficacy compared to invasive endomyocardial biopsy (RVBX) for immune surveillance of acute cellular rejection in low risk adult primary cardiac transplant recipients. However, the efficacy of Allomap® in combined heart kidney recipients is unknown. The recently published Image Trial in the New England Journal of Medicine noted the Allomap® test to have similar efficacy compared to invasive endomyocardial biopsy (RVBX) for immune surveillance of acute cellular rejection in low risk adult primary cardiac transplant recipients. However, the efficacy of Allomap® in combined heart kidney recipients is unknown. MethodsWe retrospectively evaluated 7 combined heart-kidney transplant recipients (6 males with 1 redo cardiac transplant recipient and 4 patients supported with Syncardia Total Artificial Heart). We performed protocol serial Allomap® testing at 3, 4, 6, 8 and 10 months post transplant as well as protocol RVBX's. As per our previously reported experience, we performed RVBx when Allomap® score ≥32. We retrospectively evaluated 7 combined heart-kidney transplant recipients (6 males with 1 redo cardiac transplant recipient and 4 patients supported with Syncardia Total Artificial Heart). We performed protocol serial Allomap® testing at 3, 4, 6, 8 and 10 months post transplant as well as protocol RVBX's. As per our previously reported experience, we performed RVBx when Allomap® score ≥32. ResultsTabled 1Allomap Scores in Combined Heart-Kidney RecipientsValue3 Months4 Months6 Months8 Months10 MonthsAverage1027283638Standard Deviation1.278.82.61 Open table in a new tab InferencesOur findings suggest that combined heart-kidney recipients may in fact turn on or off key genetic factors giving rise to markedly elevated Allomap® scores. These elevated scores don't appear to be a signal for either acute cellular rejection or humoral rejection at the previously adjudicated values although our sample size is too small to say that with certainty. Clearly more needs to be done to clarify this intriguing observation. Our findings suggest that combined heart-kidney recipients may in fact turn on or off key genetic factors giving rise to markedly elevated Allomap® scores. These elevated scores don't appear to be a signal for either acute cellular rejection or humoral rejection at the previously adjudicated values although our sample size is too small to say that with certainty. Clearly more needs to be done to clarify this intriguing observation.

Experience with more than 100 total artificial heart implants

The SynCardia Total Artificial Heart (SynCardia Systems Inc, Tucson, Ariz) has been used as a bridge to cardiac transplantation in 930 patients worldwide and in 101 patients in our program. Our experience with SynCardia Total Artificial Heart implantation documents its indications, safety, and efficacy. Data regarding preoperative condition, mortality, and morbidity have been reviewed and analyzed. From January 1993 to December 2009, 101 patients had bridge to transplant procedures with the SynCardia Total Artificial Heart. Ninety-one percent of cases were Interagency Registry for Mechanically Assisted Circulatory Support profile 1, and the remaining 9% of cases were failing medical therapy on multiple inotropic medications. The mean support time was 87 days (median, 53 days; range, 1-441 days). Pump outputs during support were 7 to 9 L/min. Adverse events included strokes in 7.9% of cases and take-back for hemorrhage in 24.7% of cases. Survival to transplantation was 68.3%. Causes of death of 32 patients on device support included multiple organ failure (13), pulmonary failure (6), and neurologic injury (4). Survival after transplantation at 1, 5, and 10 years was 76.8%, 60.5%, and 41.2%, respectively. The longest-term survivor is currently alive 16.4 years postimplantation. These patients were not candidates for left ventricular assist device therapy and were expected to die. The SynCardia Total Artificial Heart offers a real alternative for survival with a reasonable complication rate in appropriate candidates who otherwise might have been assigned to hospice care.

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Managing the Failing Heart: Total Circulatory Assist—A Case Study

Congestive heart failure remains one of the leading causes of cardiac death and disability. As pharmacological therapies have advanced, patients are living longer and more productive lives. However, at some point, these interventions begin to fail. Circulatory assist devices have revolutionized the management of patients with end-stage heart disease. These devices successfully bridge patients to cardiac transplantation. The Syncardia Total Artificial Heart provides biventricular support for the failing heart. This case study illustrates the challenges of caring for patients with such a device.

Managing the failing heart: total circulatory assist — a case study

Congestive heart failure remains one of the leading causes of cardiac death and disability. As pharmacological therapies have advanced, patients are living longer and more productive lives. However, at some point, these interventions begin to fail. Circulatory assist devices have revolutionized the management of patients with end-stage heart disease. These devices successfully bridge patients to cardiac transplantation. The Syncardia Total Artificial Heart provides biventricular support for the failing heart. This case study illustrates the challenges of caring for patients with such a device.