Int J Heart Fail.
2024 Apr;6(2):76-81. 10.36628/ijhf.2023.0020.
Adverse Events in Total Artificial Heart for End-Stage Heart Failure: Insight From the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE)
- Affiliations
-
- 1Division of Cardiovascular Medicine, Mayo Clinic Arizona, Phoenix, AZ, USA
- 2Department of Internal Medicine, New York Medical College at Saint Michael’s Medical Center, Newark, NJ, USA
- 3Department of Internal Medicine, Beaumont Health, Royal Oak, MI, USA
- 4Perdana University-Royal College of Surgeons in Ireland, Kuala Lumpur, Malaysia
- 5Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA
- 6Division of Cardiovascular Medicine, UC Davis Medical Center, Sacramento, CA, USA
- 7Department of Internal Medicine, Rochester General Hospital, Rochester, NY, USA
- 8Division of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA
- KMID: 2555730
- DOI: http://doi.org/10.36628/ijhf.2023.0020
Abstract
- Background and Objectives
Real-world clinical data, outside of clinical trials and expert centers, on adverse events related to the use of SyncCardia total artificial heart (TAH) remain limited. We aim to analyze adverse events related to the use of SynCardia TAH reported to the Food and Drug Administration (FDA)’s Manufacturers and User Defined Experience (MAUDE) database.
Methods
We reviewed the FDA’s MAUDE database for any adverse events involving the use of SynCardia TAH from 1/01/2012 to 9/30/2020. All the events were independently reviewed by three physicians.
Results
A total of 1,512 adverse events were identified in 453 “injury and death” reports in the MAUDE database. The most common adverse events reported were infection (20.2%) and device malfunction (20.1%). These were followed by bleeding events (16.5%), respiratory failure (10.1%), cerebrovascular accident (CVA)/other neurological dysfunction (8.7%), renal dysfunction (7.5%), hepatic dysfunction (2.2%), thromboembolic events (1.8%), pericardial effusion (1.8%), and hemolysis (1%). Death was reported in 49.4% of all the reported cases (n=224/453). The most common cause of death was multiorgan failure (n=73, 32.6%), followed by CVA/other non-specific neurological dysfunction (n=44, 19.7%), sepsis (n=24, 10.7%), withdrawal of support (n=20, 8.9%), device malfunction (n=11, 4.9%), bleeding (n=7, 3.1%), respiratory failure (n=7, 3.1%), gastrointestinal disorder (n=6, 2.7%), and cardiomyopathy (n=3, 1.3%).
Conclusions
Infection was the most common adverse event following the implantation of TAH. Most of the deaths reported were due to multiorgan failure. Early recognition and management of any possible adverse events after the TAH implantation are essential to improve the procedural outcome and patient survival.
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