Over a year after becoming the first FDA-approved transcatheter tricuspid valve replacement system, a new JACC study suggests Edwards Lifesciences’ Evoque TTVR system might have some risks that regulators hadn’t previously considered.
- The pivotal trial that led to Evoque’s approval back in February of 2024 demonstrated that it reduced symptoms and improved quality of life.
- However, a small cohort of patients receiving Evoque (n=267) reported a high incidence of adverse events during the trial, like severe bleeding and conduction disturbances requiring permanent pacing.
Searching for more answers about Evoque’s real world risks, researchers pulled data from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database to analyze adverse event reports in the first year following the Evoque system’s approval and found that…
- 150 reports were submitted to MAUDE documenting 158 adverse events.
- Bradycardia or high-degree atrioventricular block was the most common (n = 70), causing two deaths.
- Following this complication, 65 patients required permanent pacemaker implantation.
- Evoque leaflet thickening or thrombus was also identified in 20 patients.
- Cardiac tamponade (fluid build-up around the heart) was reported in eight patients while venous injury or bleeding occurred in another eight patients.
But the troubles don’t end with the device itself, as the implantation procedure also showed fatal complications like device malposition, migration, or embolization that occurred in 33 patients and caused six deaths.
- Mechanical failure of the delivery catheter was also reported in four patients, all due to nose cone separation.
- It’s worth noting that Edwards has reported this complication in only one case to date, and laboratory simulations have failed to replicate the event.
Researchers also made it clear that their study has some important limitations…
- It’s unknown exactly how many patients have received the Evoque, so there’s no denominator to compare these ADEs to.
- Causality is also impossible to determine due to a lack of on-site evaluation, and reports reflect submission time without accounting for later clinical events.
- Additionally, the FDA’s voluntary reporting system introduces biases like underreporting or selective reporting of severe cases.
The Takeaway
If you only evaluated an interventional device based solely on reports from the MAUDE database, it’s bound to seem risky. That said, there are still some unanswered questions about how these complications weren’t picked up on by regulators earlier, and physicians should consider the risks moving forward when selecting patients for TTVR with Evoque.
