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Background: Total artificial heart (TAH) implantation is a rarely performed procedure. Contrarily, left ventricular assist device (VAD) implantation is rather common in many centers. As transplantation is quantitatively limited cardiac replacement with artificial hearts is a viable alternative in the treatment of severe biventricular heart failure. An alternative to TAH is the implantation of two VADs in a TAH configuration. We hereby present the first multi-center study on 3-months outcomes of patients treated by cardiectomy and placement of two HeartMate 3s in a TAH configuration., Methods: We retrospectively investigated a cohort of 15 patients that underwent HM3-TAH-implantation at three international institutions. Follow-up was 3 months after implantation. Baseline, intra- and postoperative parameters as well as survival data and adverse events were collected., Results: A total of 1089 days on HM3-TAH were observed. Thirty-day survival after HM3-TAH implantation was 53% (8/15) and three month survival was 40% (6/15). The longest duration on device was 274 days. Causes of death were multi-organ failure, sepsis, and neurological adverse events. No technical complications were documented. Two patients remained on the device. Four patients (26%) were successfully bridged to transplantation., Conclusions: The implantation of two HeartMate 3s in a TAH configuration is a last resort and off-label concept in cases of extreme biventricular heart failure. In a diligently selected patient cohort, HM3-TAH implantation is a feasible method to increase the chance of survival in a severely ill patient cohort and successfully bridge patients to heart transplantation that would otherwise have died.

Despite maximal medican and surgical therapy, the outcomes of severe biventricular failure remain poor with mortality rates of up to 100%. The only definite therapy option for this disease is the total replacement of the heart - either by cardiac transplantation or by total artificial heart (TAH) implantation. Due to the lack of donor organs, mechanical assist devices are the most relevant option for these patients. The permanent availability of mechanical devices is especially attractive in emergency cases as well as in high-risk patients. The placement of two HeartMate 3 in the setting of a TAH is an alternative approach to pulsatile TAH implantation. We now present the worldwide first series of outcomes of this novel procedure. We performed a retrospective analysis of seven consecutive patients who underwent off-label HeartMate 3 TAH implantation after cardiectomy at two international medical institions. Data was acquired using the in-house clinical databases. Follow-up time was thirty days postoperatively. Among perioperative baseline characteristics, adverse events and survival data were collected and analyzed. The retrospective study was approved by the loca institutional ethics committee. Out of 7 patients 4 were male (57%). Primary diagnosis was dilated cardiomyopathy in four cases (4/7, 57%) Other diagnoses were stone heart syndrome, restrictive cardiomyopathy and post-partum cardiomyopathy. All patients were previously supported by ECMO. 3 patients suffered from severe ventricular thrombosis. Intraoperative mortality was 0%. One patient was successfully transplanted after 71 days on device. One patient is still on-going on the device, currently discharged and waiting for heart transplantation (POD 259). Full mobility was achieved in both patients. In all cases postoperative hemodynamic stability was successfully achieved. No device related technical complications occured. Four patients died within thirty days of support (51%; POD 10-21). Causes of death were sepsis and multi-organ failure (3/4) and stroke (1/4). It has been proven that the implantation of two HeartMate 3 VADs in the settings of a total artificial heart is a feasible concept with no technical adverse events in our patient population. In this high risk patient cohort, a reduction of 30-day-mortality from 100% to 57% was achieved. [ABSTRACT FROM AUTHOR]