Results With Syncardia Total Artificial Heart Beyond 1 Year

Abstract

Mechanical circulatory support devices have been increasingly used for long-term support. We reviewed outcomes in all patients supported with a SynCardia total artificial heart (TAH) for more than 1 year to assess its safety in long-term support. As of December 2011, all 47 patients who received the TAH from 10 centers worldwide were included in this retrospective study. Clinical data were collected on survival, infections, thromboembolic and hemorrhagic events, device failures, and antithrombotic therapy. The mean age of patients was 50 ± 1.57 years, the median support time was 554 days (range 365-1373 days). The primary diagnosis was dilated cardiomiopathy in 23 patients, ischemic in 15, and "other" in 9. After a minimum of 1 year of support, 34 patients (72%) were successfully transplanted, 12 patients (24%) died while on device support, and 1 patient (2%) is still supported. Five patients (10%) had a device failure reported. Major complications were as follows: systemic infections in 25 patients (53%), driveline infections in 13 patients (27%), thromboembolic events in 9 patients (19%), and hemorrhagic events in 7 patients (14%). SynCardia TAH has proven to be a reliable and effective device in replacing the entire heart. In patients who reached a minimum of 1 year of support, device failure rate is acceptable and only in two cases was the leading cause of death. Infections and hemorrhagic events were the major causes of death. Patients who remain supported beyond 1 year are still likely to survive to transplantation.

Total Artificial Heart as the Destination Therapy: A Review

“…Device failure was reported in three studies out of which one study reported device failure in AbioCor Hemorrhagic events were found highly associated with AbioCor implantation whereas only one study reported hemorrhage association with SynCardia [7,8,10]. However, as suggested by the literature, hemorrhage remains a major limitation a result of antithrombotic therapy started to prevent thrombotic complications secondary to bulky design.…”

“…Nantes group, La Pitie group and Arizona group case series reported bleeding in 22 %, 35% and 43% of the patients respectively [5]. Neurological complications as embolic strokes were reported by two studies [7,10].…”

“…Patients with BSA less than 1.8 square meters were found to have increased incidence of death (p = 0.0045), hemorrhagic events (p = 0.009), and systemic infections (p = 0.008). A comparison of the rate of TE events with previous studies showed that long-term support on TAH does not increase the risk of TE events and fewer deaths resulted from TE events as compared to hemorrhagic episodes [10]. …”

Cardiopulmonary Resuscitation in Adults and Children With Mechanical Circulatory Support: A Scientific Statement From the American Heart Association

“…[28][29][30] The next most common cause is an increase in BP as patients improve from their heart failure. The increased afterload created by hypertension can affect device emptying and lead to pulmonary edema and respiratory distress.…”

Artificial heart creation: what problems are to be solved?

“…But unfortunately the recognized American and French artificial heart developers do not take this novel concept into account [7][8][9][10][11][12]. As a rule they use only 5 cardiac cycle phases which are incompletely and inconsistently described and interpreted in the classical research.…”