Jagger’s Heart Procedure Gives Standards Developers 'Satisfaction'
Posted April 17, 2019
When The Rolling Stones postponed their highly anticipated tour so lead singer Mick Jagger could undergo heart surgery, many fans around the world learned about the minimally invasive treatment, transcatheter aortic valve replacement (TAVR). But the successful implantation of a new valve into Jagger’s heart—completed without the need to open up his chest—is also the culmination of the work of standards professionals from around the world.
Jagger, 75, is now one of the highest-profile public figures to benefit from ISO 5840-3, Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques. That FDA-recognized standard, which provides instructions to help ensure the safety of transcatheter replacement heart valves like the one Jagger received, was developed by an AAMI-administered international working group that focuses on cardiac valves, ISO/TC 150/SC 2/WG 1.
“As Class III devices, replacement heart valves must be designed, tested, and evaluated in animal models and have clinical data because they could create harm to the patient if they don’t work properly,” said Ajit Yoganathan, PhD, convener of the working group and chair for research at the Wallace H. Coulter School of Biomedical Engineering at the Georgia Institute of Technology and Emory University. “Standards like the 5840 series are essential because they are a means for regulatory agencies to see what bench tests should be done, what kinds of animals studies should be done, and what clinical data are needed before approval.”
It’s true that standards professionals don’t usually get the same attention as the surgeons who operate on a celebrity’s heart. But that doesn’t mean that they “can’t get no satisfaction” when their work is crucial to ensuring that the implanted medical devices used in TAVR are safe and effective.
“Most people won’t know about all of the standards work that occurred when they’re having a heart valve replaced. And the surgeons may not even know. But it’s rewarding to see as the technology evolves how much impact our standards work has on saving lives,” Yoganathan said.
Today, ISO/TC 150/SC 2/WG1 is revising ISO 5840-3, last updated in 2013, to take into account increased testing and engineering needs for the rapidly evolving technology of implantable transcatheter valves, as well as the widening number of people who are eligible for TAVR—thanks in large part to years of work by standards professionals from around the world. The next working group meeting takes place in May in Amsterdam.
For more information on standards development and how you can get involved, visit www.aami.org/standards.