Background: The Commissioning through Evaluation (CtE) programme launched by NHS England in 2014 provided limited access to left atrial appendage occlusion (LAAO) at 10 UK sites for selected high risk patients. The influence of this selection process on patient outcomes has not been described.
Methods and Results: Objective CtE eligibility criteria were disseminated to our referring hospitals via our local cardiac and stroke network, leading to 143 referrals to our regional LAAO service. Following assessment by a multidisciplinary team, 83 (58%) patients (76±8.2 years, 67.5% men, mean CHAD2S2-VASc score 4.4 ±1.3) were enrolled for LAAO; all were ineligible for long term oral anticoagulation, and 95% had prior history of serious bleeding events including intracranial haemorrhage in 59%. Technical implant success with an Amulet device was achieved in 82 (98.8%). Procedure related adverse events were seen in 5 (6.0%) patients, including 2 device embolizations (both needing open surgery, one leading to in-hospital death), one pulmonary edema, and 2 bleeds requiring blood transfusion. No peri-procedural stroke or pericardial effusion occurred. Dual antiplatelet therapy (DAPT) was prescribed post-procedure for 6 weeks followed by a single antiplatelet drug for 6 months.
All 80 patients discharged following successful implant underwent close follow up (FU) in a dedicated LAAO clinic for a median of 12 months (IQR 6-16 months). Imaging with TOE (n = 61) or contrast CT (n = 14) was performed in 75 (94%) patients at a median of 2 months post implant; this showed device related thrombus in one patient (1.3%) and minor leaks (