Dr.S.Venkatesan MD

Journal Club Review : LACC for AF

What is the brief conclusion of this important study from EUROPACE ?

This meta-analysis aggregates data from 6 randomized controlled trials involving over 7000 patients to answer a burning question. Should we aggressively plug LAA in lieu of OAC or DOAC in AF ?

The short answer from this meta-analysis is a resounding “no” if our primary clinical goal is preventing ischemic stroke

Link to the article

Some observations and comments about this study

For all those cardiologists and physicians who have huge trust on LAA closure for AF , this study delivers a remarkable reality check:

• The Stroke Incidence : The very purpose these devices are implanted is reduce it. But what happens ? Patients randomized to LAA closure suffered a 41% higher relative risk of ischemic stroke or systemic embolism compared to those on oral blood thinners.
• The Harm : In a 3-4-year follow-up period, the Number Needed to Harm (NNH) may not look significant. For every 100 patients given a shiny new implant, one additional patient will experience a stroke that a simple daily pill could have prevented.
• The Bleeding Trade-off: To its credit, LAAC successfully reduce the bleeding risk associated with OAC/DOAC

Will this study change the FDA approval and guidelines ? What will be the future of LACC ?

No, Absolutely not. FDA is unlikely to react. It reviews devices based on their safety profiles for specific, indicated populations. Because these devices successfully reduce bleeding rates for patients with an absolute contraindication to blood thinners, their approval is legally and clinically sound.

The medical gadget eco-system works seamlessly . A device manufacturer proves that a LAA plug stops bleeding in a high-risk group. The device gets approved. Most of us fall for it and naturally shifts toward “liberal usage” as an easy, high-revenue alternative for patients who just don’t feel like swallowing a pill every day.

Final message : LACC is clearly a useless device , still you can use, less

With an estimated 400,000 implanted annually , it is too hard for us to say LACC is useless. The future will inevitably bring next-generation devices with fancier anti-thrombotic coatings or redesigned plugs. Meanwhile, thousands of low-risk patients will continue to undergo unnecessary procedures , forcibly accepting the risk of increased stroke for the sake of convenience & glamor.