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

Abstract

OBJECTIVES 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. METHODS 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. RESULTS 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. CONCLUSIONS 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.

An approach to quantify parameter uncertainty in early assessment of novel health technologies

“…PBA does not rely on unverifiable assumptions and will make decision-making more transparent, leading to better and more responsible decisions for patients and for a sustainable health care system. Shape parameter 0.9 [53] Probability of death while on support conditional on leaving the TAH state 1 month 0.7 [53] 2 month 0.5 [53] 3 month 0.4 [53] > 3 months 0.2 [53] Complications while on support Strokes 0.23 [53] Proportion of disabling strokes 0.12 moderate-severe disability; 0.39 Severe [53] Major bleeding 0.21 [53] Major Infection 0.7 [53] Major device malfunction 0.106 [53] Survival after HTx mu parameter -4.728 [54] Sigma parameter 0.920 [54] Shape parameter -29.795 [54] Quality of Life…”

Trends and outcomes following total artificial heart as bridge to transplant from the UNOS database

“…While most studies agree that patients undergoing heart transplants following BTT with a TAH do generally well (including our current data), the length of time on the device does correlate with posttransplant complications including pericarditis, infectious issues, and bleeding complications suggesting prolonged support duration is not without risks. 8 A previous study of the UNOS database comparing TAH to BiVAD support in an earlier era (2004-2014) demonstrates similar survival and morbidity between biventricular failure patients undergoing BTT with either device strategy with 78% versus 83% 1-year posttransplant survival for each device, respectively. 15 Identifying the proper patient for TAH BTT therapy seems to be the single largest outstanding factor after completion of our study and review of the current data.…”

“…A previous study by Arabia et al 4 of all TAH implants registered with the Interagency Registry for Mechanical Assisted Circulatory Support (INTERMACS) from June 2006 to April 2017 reported 450 implants, while the most recent INTERMACS report from the Society of Thoracic Surgeons in 2020 reports 449 TAH implants from 2010 to 2020 4,5 . Multiple single institutions and small collaborative groups have pooled data to demonstrate the safe application of the TAH technology, but it remains unknown how utilization has changed broadly in the United States, and how patients fare with TAH as a BTT treatment 2,6–8 . The United Network for Organ Sharing (UNOS) database remains the central repository tracking both the transplant listing and early transplantation outcomes of all patients undergoing orthotopic heart transplant (OHT) in the United States and collects data specifically identifying the use of the TAH system and other methods of mechanical circulatory support.…”

The Year 2020 in Review: Noteworthy Literature for Thoracic Transplant Anesthesiologists

“…The authors recommend performing sternotomy on femoral-femoral cardiopulmonary bypass with the TAH-t flowing at 40 beats per minute. 28…”