Question

Conduct the biological evaluation of the bioprosthetic heart valves as part of a risk management process based on ISO 10993 -1 (Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process). Your analysis should contain medical device categorization (nature of body contact and contact duration) and biological evaluation test required for the device.

Answer 1

Prosthetic heart valves have been commonly used to address the increasing prevalence of valvular heart disease. An ideal prosthetic heart valve substitute should closely mimic the characteristics of a normal native heart valve.
There are two commonly used basic types of prosthetic heart valves. They are 1. Mechanical heart valves and 2. Biological heart valves.
Mechanical heart valves athe implanted surgically, whereas biological heart valves can be implanted either surgically or by a micro-invasive transcatheter approach).

Biological Heart Valves are have the following properties:
(i) They are effective and durable, particularly in older patients (>60 years)
(ii) They do not have thrombogenicity complications and circumvent the problem of anti-coagulation medications.

The presently used Biological Heart Valves are derived from porcine aortic valves and calf-pericardium. These are preserved by glutaraldehyde fixation and anti-mineralization.
glutaraldehyde fixation prevents immunogenicity and anti-mineralization can diminish cusp calcification.
Biological heart valves have significantly improved hemodynamic results, lower gradients and larger aortic valve/orifice areas.
Biological heart valves are not as mechanically robust compared to MHVs and exhibit limited durability in younger patients.
BHVs have a significantly greater probability of death in patients between age 40–49, compared to the older age groups (50–69 and 70–79).
Older patients are less likely to outlive the BHV durability, whereas younger patients may prefer to opt for BHVs to avoid committing to lifestyle changes.
BHVs would be a preferred option for many women who desire to have children.