Purpose of the study: The Center for Medicare & Medicaid Services recently proposed to restrict reimbursement for left atrial appendage occlusion (LAAO) to certain patient- and process-specific criteria. In 2014, NHS England imposed similar criteria limiting LAAO reimbursement to 10 selected sites as part of the Commissioning through Evaluation (CtE) process. We aimed to assess the impact of CtE
... [Show full abstract] on procedural and patient outcomes.
Method used: To comply with stringent CtE requirements, our institution developed a multidisciplinary team (MDT) process including stroke physicians and non-invasive cardiologists to assess eligibility for LAAO. LAAO implants were co-performed by an electrophysiologist and an interventional cardiologist. Procedural and follow-up data were prospectively entered into a central NHS database.
Summary of results: Between Aug 2014 and Nov 2015, 77cases were referred to MDT (age 75 ± 9 yrs, 48 males). The MDT approved LAAO for 53/77 (69%) patients; 42 underwent the procedure, 8 are pendingand3 declined. Thirteen of 77 (17%) patients were started on a novel oral anticoagulant, 4/77 (5%) weremaintained on watchful waiting, and 3/77 (4%) are undergoing further tests, while4/77 (5%) referrals were deemed inappropriate.
42 patients (mean age 75 ± 9 years, 25 males, median CHA2DS2VASc 4, median HAS-BLED 2) underwent LAAO under TEE guidance. The Amplatzer Cardiac Plug was used in 3 (7%) cases and Amplatzer Amulet in 39 (93%). Procedural success rate was 100% (procedure time 93 ± 29 min, fluoro time 14 ± 8 min). Hemorrhage requiring blood transfusion occurred in 2 (5%) cases;no device-related complications were seen.
Clinical follow-up beyond 6 weeks is available for 36patients so far. At a median follow-up of 122 days [IQR 81-293], 31patients (86%) are free of haemorrhagic or thromboembolic events, 1 (3%) suffered a stroke 12 months post-LAAO, 3 (8%) had bleeding events, and 1 (3%) died. Of the 32 patients who have undergone follow-up imaging at 6–8 weeks, good LAA seal without any residual leak was seen in 28 (88%) and 4 (12%) patients had a small <5 mm leak.
Conclusion: The CtE process has changed our clinical practice. Careful patient selection resulted in high LAAO implant procedural success, a low complication rate and high rate of appendage seal on follow-up imaging.
