This month’s registry spotlight is on the Left Atrial Appendage Occlusion (LAAO) Registry through the National Cardiovascular Data Registry.
Registry Partners’ Cardiac Services team assists facilities and institutions nationwide with their LAAO data collection efforts. We serve as a complete outsource solution or can augment the facility’s current data collection team to ensure high quality, timely, and accurate data collection and submission.
Read on to learn more about the Left Atrial Appendage Occlusion (LAAO) Registry.
What is the Purpose of the LAAO Registry?
The LAAO registry was created to support quality improvement activities that will improve the lives of people with Non-Valvular Atrial Fibrillation (NVAF) and to meet CMS requirements.
Left Atrial Appendage Occlusion (LAAO) is a non-drug treatment for reducing stroke risk, as well as an alternative to anticoagulation in patients with NVAF, who are not suited for long-term anticoagulation, yet appropriate for short-term anticoagulation.
- Atrial Fibrillation is a common heart arrhythmia, affecting 1:20 people over the age of 65 and 1:10 over the age of 75.
- NVAF is implicated in about 15% of all ischemic strokes, and as many as 30% of strokes occurring in people in their 80’s.
- Studies have shown that in strokes caused by NVAF, 90% of the thromboembolisms that originate in the left atria are from the left atrial appendage (LAA).
Medicare Patient Criteria:
- A CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3.
- The patient must be suitable for short-term anticoagulation but considered unable to take long term oral anticoagulants.
- A formal shared decision discussion completed by an independent non-interventional physician using an evidence-based decision tool about oral anticoagulation post-procedure.
- A patient must be suitable for short-term warfarin but deemed unable to take long term oral anticoagulation following the conclusion of shared decision making, as LAAO is only covered as a second-line therapy to oral anticoagulants.
- The procedure must be furnished in a hospital with an established electrophysiology and/or structural heart disease program. The patient is under the care of a multidisciplinary team pre and postoperatively,
- The procedure must be performed by an interventional cardiologist(s), electrophysiologist (s) or cardiovascular surgeon (s) that meet the following criteria:
- Has received training prescribed by the manufacturer on the safe and effective use of the device prior to performing Left Atrial Appendage Closure (LAAC); and
- Has performed ≥ 25 interventional cardiac procedures that involve trans-septal puncture through an intact septum; and
- Continues to perform ≥ 25 interventional cardiac procedures that involve trans-septal puncture through an intact septum, of which at least 12 are LAAC, over two years.
- The hospital must take part in a prospective, national, audited registry that:
- Consecutively enrolls LAAO patients; and
- Tracks the following annual outcomes for each patient for a period of at least four years from the time of the LAAO:
- Operator-specific complications
- Device-specific complications including device thrombosis
- Stroke, adjudicated by type
- Transient Ischemic Attack (TIA)
- Systemic Embolism
- Major Bleed by site and severity
- Follow up must occur at prescribed intervals 45 days, 6 months, 1 and 2 years from the date of implant.