title: A brief review of ventricular assist devices and a recommended protocol for pathology evaluations.
abstract: Heart failure is a leading cause of death in human populations, and as people live longer, it is becoming an increasingly prominent problem. Because of the insufficient numbers of donor hearts, physicians and engineers are turning to mechanical circulatory support in the form of ventricular assist devices (VADs). Their clinical performance and increasing availability of various types, sizes, and functions are increasing VAD recognition. However, for any implantable medical device, especially one that is life supporting, performance and safety must be evaluated both pre- and postmarket. It has been demonstrated that specific pathology analysis can provide unique and important information to augment the evaluation of performance and safety. To help ensure the safety and efficacy of a device, we propose that regulatory agencies include pathology analysis by experienced, independent pathologists with relevant expertise as an integral component of device submissions. We believe that this analysis should include both gross and microscopic components and, when warranted, supplementary data obtained through radiography, electron microscopy, or both. The pathology data acquired through these analyses should be correlated with clinical data to yield a more thorough data set for submission to the governing regulatory body. Submitting this coordinated analysis of data will demonstrate to regulatory agencies (United States Food and Drug Administration, Therapeutic Goods Administration, Brazilian Health Surveillance Agency, etc.) that the device manufacturer shares their objective: making medical devices as safe and effective as possible.
  
  
  CONCLUSIONS
  This review of ventricular assist devices introduces a recommended protocol for pathology evaluations of devices from organizations or researchers seeking approval by a governing regulatory agency.
authors.affiliation: Department of Biomedical Engineering, Cardiovascular Pathology Laboratory, College of Veterinary Medicine, 4467 Texas A&M University, College Station, TX 77843, USA.
authors.forename: Brian A
authors.initials: BA
authors.lastname: Carpenter
authors.forename: Christian J
authors.initials: CJ
authors.lastname: Gonzalez
authors.forename: Staci L
authors.initials: SL
authors.lastname: Jessen
authors.forename: Erica J
authors.initials: EJ
authors.lastname: Moore
authors.forename: Amber N
authors.initials: AN
authors.lastname: Thrapp
authors.forename: Brad R
authors.initials: BR
authors.lastname: Weeks
authors.forename: Fred J
authors.initials: FJ
authors.lastname: Clubb
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic; D004869:Equipment Safety / Q000592:standards; D006333:Heart Failure / Q000473:pathology / Q000601:surgery; D016027:Heart Transplantation; D006353:Heart-Assist Devices / Q000145:classification / Q000592:standards; D006801:Humans; D011474:Prosthesis Design; D014481:United States; D014486:United States Food and Drug Administration
keywords: Device regulation recommendations; Pathology; VAD; Ventricular assist device