Left atrial appendage closure (LAAC) is a relatively newer type of procedure. It is designed to lower the risk of deadly or debilitating stroke in patients with Atrial Fibrillation (AFib). Current FDA guidance is that these procedures are recommended only for patients who cannot tolerate treatment with anticoagulation therapy. We will explore the devices in this procedure as well as the left atrial appendage closures market trends.
The three devices that make up the majority of the device implantations used worldwide for LAAC are:
How Atrial Fibrillation Affects The Left Atrium
In normal cardiac function, the electrical currents of the heart cause the heart to beat in a regular, rhythmic fashion. Atrial Fibrillation (AFib) changes the electrical currents. This causes the heart to no longer beat in a regular, rhythmic fashion; instead the atrium contracts in an irregular and quick pattern. This means that blood is no longer moving through the ventricles and the rest of the body in the manner it should.
The LAA is a small chamber off the Left Atrium. It forms a pocket with varying physical attributes. During normal cardiac function, blood moves in and out of this pocket. In people with nonvalvular AFib, however, blood tends to pool in the LAA. This pooling creates stagnant blood which can coagulate into blood clots (thrombi).
Treatments In The Past
Patients with nonvalvular AFib are at higher risk of stroke due to the anatomy of the heart. Most patients can be treated with anticoagulation therapy medications. Prior to the endovascular LAA occlusion and exclusion devices, treatment for patients with non-valvular AFib who were not candidates for anticoagulation therapy consisted of surgically removing the LAA and then suturing the area closed. This was not a minimally invasive procedure; there were significant risks associated with the open procedure.
Left Atrial Appendage Closure Devices
Treatment with Watchman and Amulet are both endovascular. While there are still risks, the risks do seem to outweigh the long term benefits. The major post-op complications are associated with the device perforating the heart muscle, not properly closing off the LAA allowing thrombi to escape, and thrombi associated with the devices themselves. However, studies have shown that there is a 72% reduction in bleeding events at 6 months post-op, and a 55% reduction in disabling or fatal strokes. For a more in-depth comparison, watch this video on the differences between the Amulet and Watchman devices.
Long term costs of both devices are lower than the cost of traditional treatment using anticoagulants. This long term cost savings has helped convince insurance companies to cover the implants. Cost savings are even greater when potential health complications related to anticoagulation therapy are factored in.
AtriClip is an endocardial device. It’s inserted directly via a thoracoscopic approach. AtriClip is designed to deliver consistent pressure along the length of the clip. The design mimics traditional removal of the LAA. However, there is no suturing or cutting, which significantly reduces bleeding and tearing risks. The AtriClip line of devices comes in a variety of sizes and configurations. This allows for use in many patients with a variety of LAA anatomical differences.
Left Atrial Appendage Closure Devices Market Trends
According to a 2019 Energias Market Research release, the LAA closure market is estimated to reach $958 million globally by 2025. This makes it the second fastest growing medical device market. It’s one that supply chain executives will need to monitor as not only the number of devices available for use is expected to grow, but also the number of patients using the devices over the next 5 years. Trends driving the forecasted growth include but are not limited to: an aging population, adoption of new therapies, wider application of new technologies, greater recognition of AFib, and recognition of long-term cost savings of LAAC over traditional treatment with medications.
The Curvo Research Network (CRN) reviewed data for calendar years (CY) 2017 to 2018. The data set included all Watchman and AtriClip LAAC sales by dollar. Thirty-six hospitals had trend data. Sales increased from CY2018 over CY2017 by 61.8%. Atriclip sales increased by 18.7%. Watchman sales increased by 67.6%.
CRN also reviewed case use data from CY2018 and CY2019 for the same 36 hospitals. Watchman use rose by 67.1% over that time. AtriClip use rose by 8%.
Current Clinical Studies And Trials
There are several LAAC studies currently taking place.
- The Amulet was approved in February of 2020 for the CATALYST trial. This trial will study the effectiveness of the Amulet vs non-vitamin K antagonist oral anticoagulant (NOAC) drugs.
- The Watchman FLX is being tested to see if it will fit more types of LAA anatomy and thereby open the procedure up to a broader range of patients.
- AtriCure, the makers of the AtriClip, acquired SentreHeart in August of 2019. They are testing the Lariat device (which uses suturing and ablation) to see if it is safe and effective when used with pulmonary vein isolation.
For more information on the Left Atrial Appendage Closure procedure and all the components that go into it, download the LAAC Procedure Basics pdf.