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).

Autor:	Tan MC; Division of Cardiovascular Medicine, Mayo Clinic Arizona, Phoenix, AZ, USA.; Department of Internal Medicine, New York Medical College at Saint Michael's Medical Center, Newark, NJ, USA., Yeo YH; Department of Internal Medicine, Beaumont Health, Royal Oak, MI, USA., Tham JW; Perdana University-Royal College of Surgeons in Ireland, Kuala Lumpur, Malaysia., Tan JL; Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA., Fong HK; Division of Cardiovascular Medicine, UC Davis Medical Center, Sacramento, CA, USA., Tan BE; Department of Internal Medicine, Rochester General Hospital, Rochester, NY, USA., Lee KS; Division of Cardiovascular Medicine, Mayo Clinic Arizona, Phoenix, AZ, USA., Lee JZ; Division of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA.
Jazyk:	angličtina
Zdroj:	International journal of heart failure [Int J Heart Fail] 2023 Sep 18; Vol. 6 (2), pp. 76-81. Date of Electronic Publication: 2023 Sep 18 (Print Publication: 2024).
DOI:	10.36628/ijhf.2023.0020
Abstrakt:	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. Competing Interests: Conflict of Interest: The authors have no financial conflicts of interest. (© 2024. Korean Society of Heart Failure.)
Databáze:	MEDLINE
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