Temporary Total Artificial Heart Research Articles

Experience With SynCardia Total Artificial Heart as a Bridge to Transplantation in 100 Patients

BackgroundThe SynCardia temporary total artificial heart (TAH-t) is an effective bridge to transplantation for patients with severe biventricular failure. However, granular single-center data from high-volume centers are lacking. We report our experience with the first 100 TAH-t recipients. MethodsA prospective institutional database was used to identify 100 patients who underwent 101 TAH-t implantations between 2012 and 2022. Patients were stratified and compared according to Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 vs 2 or greater. Median follow-up on device support was 94 days (interquartile range, 33-276), and median follow-up after transplantation was 4.6 years (interquartile range, 2.1-6.0). ResultsOverall, 61 patients (61%) were successfully bridged to transplantation and 39 (39%) died on TAH-t support. Successful bridge rates between INTERMACS profile 1 and INTERMACS profile 2 or greater patients were similar (55.6% [95% CI, 40.4%-68.3%] vs 67.4% [95% CI, 50.5%-79.6%], respectively; P = .50). The most common adverse events (rates per 100 patient-months) on TAH-t support included infection (15.8), ischemic stroke (4.6), reoperation for mediastinal bleeding (3.5), and gastrointestinal bleeding requiring intervention (4.3). The most common cause of death on TAH-t support was multisystem organ failure (n = 20, 52.6%). Thirty-day survival after transplantation was 96.7%; survival at 6 months, 1 year, and 5 years after transplantation was 95.1% (95% CI, 85.4%-98.4%), 86.6% (95% CI, 74.9%-93.0%), and 77.5% (95% CI, 64.2%-86.3%), respectively. ConclusionsAcceptable outcomes can be achieved in the highest acuity patients using the TAH-t as a bridge to heart transplantation.

SynCardia Temporary Total Artificial Heart: Single-Center Experience at a Children's Hospital.

The SynCardia temporary total artificial heart (TAH-t) is a pneumatically driven pulsatile device that replaces a patient's ventricles and all four valves. It is now available in two sizes and can be used in patients with sufficient chest size as a bridge to transplant or destination therapy. We describe our experience at a children's hospital with the TAH-t. Seven patients implanted with a TAH-t at Cincinnati Children's Hospital Medical Center from November 2012 to March 2021 were included. Duration of support ranged from 10 to 414 days with a median of 27 days. There was a trend toward decreased time to extubation and intensive care unit (ICU) length of stay, with the three most recent patients being extubated on postoperative day 1. Seventy-one percent of the patients were successfully transplanted following their TAH-t placement. Children and young adults with transplant graft failure requiring durable, biventricular support with a TAH-t had superior outcomes (75% survival to retransplant) than previously described.

A Bridged Approach to Heart Transplantation Using ECMO and Total Artificial Heart Implantation

Purpose The rapid increase of the use of extracorporeal membrane oxygenation (ECMO) as a direct bridge to heart transplantation (HT) raises concerns. The objective of this study is to describe the outcomes after HT using a bridge-to-bridge strategy with a sequence of ECMO support followed by temporary total artificial heart (t-TAH) implantation. Methods A retrospective, multicentric analysis of 54 patients who underwent t-TAH (SynCardia) implantation following the use of an ECMO for cardiogenic shock was performed (ECMO-t-TAH group). A control group of 163 patients who underwent t-TAH implantation as a direct bridge to transplantation (t-TAH group) was used to assess the impact of this strategy. Results Fifty-four patients, averaging 47±13 years old underwent implantation of a t-TAH after 5.3±3.4 days of ECMO perfusion for cardiogenic shock. In the ECMO-t-TAH group, 20 patients (20/54,37%) died after t-TAH implantation and 57 patients (57/163,35%) died in the t-TAH group (p=0.4968). Overall, 32 patients (32/54, 59%) underwent heart transplantation in the ECMO-t-TAH group, compared to 106 patients (106/163, 65%) in the t-TAH group (p=0.4449). No significant difference in survival was observed at 6 months, 1 and 3 years after heart transplant (ECMO-t-TAH group: 94%, 87%, and 80% vs. 87%, 83%, and 76% in the t-TAH group, respectively). Deterioration of liver function tests under t-TAH was associated with increased mortality before heart transplant in both groups. Conclusion The present series suggests that sequential bridging from ECMO to t-TAH followed by heart transplantation is a viable alternative for a group of highly selected patients.

Outcomes after heart transplantation and total artificial heart implantation: A multicenter study

We sought to assess the outcomes after heart transplantation (HT) of patients supported with a temporary total artificial heart (t-TAH) as a bridge to transplantation in high-volume centers. A retrospective analysis of 217 consecutive patients who underwent t-TAH (SynCardia Systems, Tucson, Arizona) implantation between January 2014 and May 2019 in 6 high-volume North American centers was performed. End points included survival and adverse events after t-TAH and HT. The mean age of patients was 49 ± 12 years, and heart failure etiologies were non-ischemic dilated cardiomyopathy (36%), ischemic (25%), restrictive (12%), and cardiac graft failure (9%). A total of 101 (48%) patients had Interagency Registry for Mechanically Assisted Circulatory Support patient profile 1, and 65 (31%) had Interagency Registry for Mechanically Assisted Circulatory Support patient profile 2. At the end of the study period, 138 of 217 (63.5%) patients had undergone HT, and 75 (34.5%) patients died before HT. The mean time between t-TAH implantation and HT averaged 181 ± 179 days (range: 0-849) and the mean follow-up after HT was 35 ± 25 months. The overall survival in the entire cohort was 75%, 64%, and 58% at 1, 2, and 5 years, respectively. Post-transplant survival was 88%, 84%, 79%, and 74% at 6 months, 1 year, 2 years, and 5 years, respectively. Among the 32 patients (23%) who died after HT, the main causes of death were chronic allograft vasculopathy (25%), multiorgan failure (21.8%), sepsis (15.6%), and stroke (9%). In this multicenter study, almost two thirds of patients implanted with a t-TAH could be transplanted. The overall and post-transplantation survival after t-TAH was satisfactory in these critically ill patients.

A heart transplant after total artificial heart support: initial and long-term results.

At our centre, the SynCardia temporary Total Artificial Heart (TAH-t) (SynCardia Systems, LLC, Tucson, AZ, USA) is used to provide long-term support for patients with biventricular failure as a bridge to a transplant. However, a heart transplant (HT) after such support remains challenging. The aim of this retrospective study was to assess the immediate and long-term results following an HT in the cohort of patients who had a TAH-t implant. A total of 73 patients were implanted with the TAH-t between 1988 and 2019 in our centre. Of these 73 consecutive patients, 50 (68%) received an HT and are included in this retrospective analysis of prospectively collected data. In the selected cohort, in-hospital mortality after an HT was 10% (n = 5). The median intensive care unit stay was 33 days (range 5-278). The median hospital stay was 41 days (range 28-650). A partial or total pericardiectomy was performed during the HT procedure in 21 patients (42%) due to a severe pericardial reaction. Long-term survival rates after an HT at 5, 10 and 12 years were 79.1 ± 5.9% (n = 32), 76.5 ± 6.3% (n = 22) and 72.4 ± 7.1% (n = 12), respectively, which was similar to the long-term survival for a primary HT without TAH-t during the same period (n = 686). An HT performed within 3-6 months post-TAH-t implantation appeared to provide the best survival (P = 0.007). Eight (16%) patients required chronic dialysis during the subsequent follow-up period, with 3 patients requiring a kidney transplant. The long-term outcomes with the SynCardia TAH-t as a bridge to transplant in patients with severe biventricular failure are very encouraging. Our review noted that an HT following TAH-t can be technically challenging, especially in the case of a severe pericardial reaction, with potential pitfalls that should be recognized preoperatively.

New Approach to the Treatment of Patients in Intermac 1 or 2 Biventricular Failure and on ECMO with the Syncardia Temporary Total Artificial Heart

The objective of the present study is to review the clinical experience of 5 North American Centers with the Syncardia (temporary) Total Artificial Heart focusing on the most recent data with patients in biventricular failure and in patients staged to TAH after ECMO or temporary mechanical support devices. Access to transplantation and survival were the two most significant outcomes of the study. Moreover, we sought to determine the effect of end-organ recovery while on TAH on transplant accessibility and outcomes. The rationale for the present study is to understand how patient selection, timing of TAH implantation, the need for ECMO at the time of TAH implantation, the recovery of end-organ function during TAH support affect patient survival, accessibility to and outcomes after heart transplantation. We hypothesized that properly selected patients in Intermacs clinical status 1 and 2 with biventricular failure and patients supported on ECMO have significant survival rate after TAH implantation and after heart transplantation. Moreover, we suggest that renal and hepatic insufficiency developing in patients in Intermacs clinical status I and 2 can recover under TAH support and that these patients can eventually qualify for heart transplantation. We also believe that properly selected patients whom cannot be weaned from ECMO could benefit from TAH implantation and heart transplantation. A registry of all consecutive adult patients who received a TAH from January 2013 to June 2019 from participating centers was established and centralized at the Montreal Heart Institute. More than 200 patients are included in the study population. Descriptive statistics, Cox proportional hazard models and log-rank tests will be used to study the relationship between patient characteristics before TAH implantation and outcomes after TAH surgery and following heart transplantation. Survival to TAH implantation, to heart transplantation and after transplantation. Impact of ECMO support at the time of TAH implantation on survival and access to transplantation. Effects of pre TAH renal and hepatic insufficiency on survival after TAH implantation and after heart transplantation.

The total artificial heart in pediatrics: outcomes in an evolving field.

The use of the SynCardia temporary total artificial heart (TAH-t) in adults has increased with time. The development of the smaller, 50 cc TAH-t has expanded the potential applications of the device in children. We sought to describe the evolving use of the TAH-t over time and describe outcomes in the current era. The SynCardia database was queried to identify all pediatric patients ≤18 years of age implanted with the device between December 1985 and October 2019. Patient demographics, clinical outcome and support characteristics collected. Fifty-one children were supported, 36 with the 70 cc TAH-t and 15 with the 50 cc TAH-t with a total support time of 6,243 days. The number of implants has increased with time (19 between 2015 and 2019). A total of 13 patients have been converted to Freedom Driver support, seven 50 cc TAH-t and six 70 cc TAH-t. The majority of implants in the last 5 years (15/19, 79%) have been with the 50 cc TAH-t. The most common diagnosis was dilated cardiomyopathy [24 (47%)] and the average age at the time of implant was 16±2 years old. Overall survival for the patient cohort was 71%. The use of the SynCardia TAH-t to support children with end-stage heart failure has increased over time. Clinical outcomes with both the 50 cc and 70 cc TAH-t are similar to reported outcomes in adults who require TAH-t or other methods of biventricular support.

Interagency registry for mechanically assisted circulatory support report on the total artificial heart.

We sought to better understand the patient population who receive a temporary total artificial heart (TAH) as bridge to transplant or as bridge to decision by evaluating data from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database. We examined data related to survival, adverse events, and competing outcomes from patients who received TAHs between June 2006 and April 2017 and used hazard function analysis to explore risk factors for mortality. Data from 450 patients (87% men; mean age, 50 years) were available in the INTERMACS database. The 2 most common diagnoses were dilated cardiomyopathy (50%) and ischemic cardiomyopathy (20%). Risk factors for right heart failure were present in 82% of patients. Most patients were INTERMACS Profile 1 (43%) or 2 (37%) at implantation. There were 266 patients who eventually underwent transplantation, and 162 died. Overall 3-, 6-, and 12-month actuarial survival rates were 73%, 62%, and 53%, respectively. Risk factors for death included older age (p = 0.001), need for pre-implantation dialysis (p = 0.006), higher creatinine (p = 0.008) and lower albumin (p < 0.001) levels, and implantation at a low-volume center (≤10 TAHs; p < 0.001). Competing-outcomes analysis showed 71% of patients in high-volume centers were alive on the device or had undergone transplantation at 12 months after TAH implantation vs 57% in low-volume centers (p = 0.003). Patients receiving TAHs have rapidly declining cardiac function and require prompt intervention. Experienced centers have better outcomes, likely related to patient selection, timing of implantation, patient care, and device management. Organized transfer of knowledge to low-volume centers could improve outcomes.

SynCardia Temporary Total Artificial Heart as Bridge to Transplantation: Current Results at La Pitié Hospital

The SynCardia temporary total artificial heart (t-TAH) provides complete circulatory support by replacing both native cardiac ventricles and all cardiac valves. We performed a retrospective analysis of demographics, clinical characteristics and survival of patients bridged to transplantation using the SynCardia t-TAH (SynCardia Systems Inc, Tucson, AZ). From 2000 to 2010, the SynCardia t-TAH was implanted in 90 consecutive patients (80 males; mean age, 46 ± 13 years) suffering cardiogenic shock secondary to idiopathic (n= 40, 46%) or ischemic (n= 24, 27%) cardiomyopathy or other causes. Before implantation, 7(9%) patients had cardiac arrest, 27 (33%) were on ventilator, and 18 (22%) were on extracorporeal life support. Pre-implant creatinine values were 1.7 ± 0.97 mg/dL and total bilirubin levels were 45 ± 32 μmol/L; mean duration of support was 84 ± 102 days. Thirty-five (39%) patients died while on support after a mean of 62 ± 107 days. Actuarial survival on device was 74% ± 5%, 63% ± 6%, and 47% ± 8% at 30, 60, and 180 days after implantation. While on support, 9 (10%) patients suffered stroke, 13 (14%) had mediastinitis, and 35 (39%) required surgical reexploration for bleeding, hematoma, or infection. Multivariate analysis revealed that older recipient age and preoperative mechanical ventilation were risk factors for death while on support. Fifty-five (61%) patients were transplanted after a mean of 97 ± 98 days of support. Actuarial survival rates were 78% ± 6%, 71% ± 6%, and 63% ± 8% at 1, 5, and 8 years after transplantation. The SynCardia t-TAH provided acceptable survival to transplantation rates with a remarkably low incidence of neurologic events. Posttransplant survival was similar to that of patients undergoing primary heart transplantation in France.

Synthetic ECG-Gated Cardiac Computed Tomography for In Vivo Imaging of the Temporary Total Artificial Heart

To date, there have been >1000 implantations of temporary total artificial hearts (TAH-t). As expected, complications related to the use of the TAH-t can occur.1 A noninvasive imaging modality that would be capable of diagnosing mechanical failure, surgical complications, and thromboembolic phenomena related to the TAH-t is desirable. Echocardiography is not suitable to evaluate a TAH-t because ultrasound cannot penetrate air and the polyurethane components in the TAH-t assembly. Cardiac magnetic resonance imaging is likewise unsuitable because of the susceptibility to artifacts that the titanium valve components in the TAH-t would create. Conventional computed tomography (CT) is limited by motion artifact.2 Cardiac CT (CCT) can produce motion-artifact–free images of the heart. If performed with retrospective gating, CCT can also be used to acquire time-resolved images. However, CCT requires simultaneous recording of the patient’s ECG, and patients who have a TAH-t do not generate an ECG. Consequently, a variation in technique is necessary to image patients with TAH-t with this modality. Detailed below …

The SynCardia Temporary Total Artificial Heart—Evolving Clinical Role and Future Status

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The SynCardia freedom driver: A portable driver for discharge home with the total artificial heart

In March 2010, the U.S. Food and Drug Administration approved the SynCardia Freedom Driver (SynCardia Systems Inc, Tucson, AZ) for an investigational device exemption study. We report the first use in our institution of the SynCardia temporary total artificial heart (TAH-t) Freedom Driver in a 41-year-old African American man (body surface area, 2.1 m2) 12 years after he underwent orthotopic heart transplant for anti-cardiolipin antibody-related thrombotic infarction.

264: Home Discharge with CardioWest-t Total Artificial Heart – Single Center Experience

The CardioWest temporary total artificial heart (TAH-t; SynCardia, Inc, Tucson, AZ) has been approved and successfully implemented as a temporary device for bridge to cardiac transplantation. After hospitalization and convalescence in a reahilitation center, patients with CardioWest-t in Europe may be discharged from hospital to a home setting, while waiting for a donor organ. We present our single-center experience with outpatient management and follow-up of CardioWest-t recipients.

CardioWest temporary total artificial heart

The CardioWest temporary total artificial heart (TAH-t) replaces both native ventricles of the heart and is more beneficial for a select group of patients than most other typical ventricular assist devices (VADs). This review will expand on the current literature and highlight the chronology of this device. The CardioWest TAH-t has been implanted in over 715 patients at 30 multiple institutional centers worldwide as a bridge-to-transplant (BTT) since 1993. The mechanical flow dynamics of the device are manufactured and designed differently from other traditional VADs, allowing increased outputs and normal filling pressures, allowing for sufficient organ and tissue perfusion and dramatic recoveries, allowing patients to return to an almost normal quality of life. There was a 79% survival to transplant achievement in the protocol group who received the TAH-t versus a 46% in the control group (P < 0.001). Furthermore, there was a 70% survival rate at one year in the protocol group versus 31% in the control group (P < 0.001). The one- and five-year survival rates after transplantation were 69% and 34%, respectively, in the control group and 86% and 64%, respectively, in the protocol group. It is evident that the advancement of modern engineering and medicine has made way for a reliable and durable device that provides a promising future in the field of end-stage heart failure.

196: Single Center Experience with 104 Total Artificial Heart Implant Patients

The SynCardia Cardiowest temporary Total Artificial Heart (TAH-t) was approved by the FDA on October 15, 2004 for in-hospital use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. It provides up to 9.8 L/min flow at low central venous pressure, which permits rescue of very sick potential cardiac recipients. Over 750 patients have been implanted with this device worldwide and we present 104 of those implants which occurred at our center.

Successful Use and Dosing of Bivalirudin After Temporary Total Artificial Heart Implantation: A Case Series

The temporary total artificial heart (TAH-t) has emerged as an effective bridge to transplantation for individuals with biventricular failure. Implantation of a TAH-t creates a hypercoagulable state requiring a multidrug approach that includes low-dose unfractionated heparin (UFH) in order to minimize thromboembolism. A concern with UFH is the development of heparin-dependent antibodies, which develop in up to 50% of patients receiving the drug as part of cardiopulmonary bypass. If UFH therapy continues postoperatively, the risk of heparin-induced thrombocytopenia approaches 3%. Small investigations have demonstrated that bivalirudin, given as a bolus of 0.75-1 mg/kg followed by an infusion at 1.75-2.5 mg/kg/hour, is an effective alternative to UFH for therapeutic anticoagulation during coronary artery bypass surgery, valve replacement, or both. We describe a series of five adults (age range 24-58 yrs) who received bivalirudin as an alternative to low-dose UFH after TAH-t implantation. None of the patients had documented heparin-induced thrombocytopenia. Treatment was started at the discretion of the treating physician, and adjustments were based principally on the results of thromboelastography. Additional general monitoring included activated partial thromboplastin time, prothrombin time, international normalized ratio, fibrinogen, D-dimer, platelet count, hemoglobin, hematocrit, and platelet aggregation studies. Bivalirudin therapy was continued until successful warfarin implementation. All five patients received bivalirudin in addition to standard antithrombotic therapy. Bivalirudin treatment started at a dosage of 0.005 or 0.01 mg/kg/hour with titration to maintain normocoagulability, which occurred (without concomitant warfarin therapy) within the dosage range of 0.01-0.02 mg/kg/hour. Duration of TAH-t implantation was a mean of 38.8 days (range 25-60 days), and bivalirudin was continued for a mean of 15.2 days (range 7-24 days). No major hemorrhagic events occurred during treatment, and all patients successfully transitioned to warfarin therapy. Low-dose bivalirudin, as an alternative to UFH, maintained normocoagulability after TAH-t implantation. Further investigation is warranted to define the role and dosing of bivalirudin in this situation.

Chest Radiographic and Computed Tomographic Findings of the Temporary Total Artificial Heart (TAH-t)

We describe the chest radiographic and computed tomographic appearances of the temporary total artificial heart in 2 patients.

Section 10: Surgical Approaches to the Treatment of Heart Failure

Section 10: Surgical Approaches to the Treatment of Heart Failure

Total Artificial Heart Bridging: A Temporary Support for Deteriorating Heart Transplantation-Candidates - Methods and Results

Since 1975 at the 2. Dept. of Surgery, University of Vienna, Austria, artificial circulation devices and artificial hearts have been constructed and in experimental use. We started a clinical heart transplantation (HTX) program in 1984, and up to now more than 40 HTXs have been performed. Since May 1986, 3 patients--all suffering from end stage dilatative cardiomyopathy--received total artificial heart (TAH) as a temporary support until HTX was possible. Two of them were transplanted after 9 and 10 days. The third patient, who additionally suffered from a postinfarctial lung abscess and had to undergo an indispensable lobectomy contemporary with TAH implantation, could not be transplanted due to an incurable infection, which he died of after 22 days on TAH. The temporary TAH implantation proved to be a valuable measure preventing life-threatening circulatory deterioration. After restoration of a sufficient circulation by the implanted system, the patients' general conditions improved and the concomitant dysfunctions of kidneys, brain, and other vital organs, due to cardiogenic shock, could be rectified in those two patients, who underwent transplantation. Thromboembolic complications were observed only in the third patient, who developed a small infarction in the anterior lobe of the left hemisphere caused by cerebral embolism after 3 weeks of TAH pumping. The use of TAH is liable to severe, even lethal, complications. At present it should be used only as a last resort. If a donor heart is not available, this measure can be a real chance to save the patient's life.