16Left atrial appendage occlusion in patients meeting the “commissioning through evaluation” eligibility criteria: high all-cause mortality seen in spite of successful device implant

Abstract

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 (<5mm) in 13 (17.3%). Major extracranial bleeding was observed in 5 (6.3%) patients, of which 4 occurred whilst patients were still on DAPT. Over FU, 3 (3.8%) patients experienced an ischemic stroke and 2 (2.5%) patients a haemorrhagic stroke. Based on the CHAD2S2-VASc score, this represented a 51% relative risk reduction in comparison to the expected rate with aspirin therapy alone. However, an all-cause mortality of 10% (n=8) was seen, with only 1 (1.3%) patient dying of cardiovascular causes (Figure). Conclusion(s): LAAO is a viable option with a high technical success rate and low but not insignificant risk of procedural complications. However, the risks and benefits of LAAO need to be evaluated carefully on a case-by-case basis, as competing causes of mortality in a very high-risk population have the potential to negate some of the stroke-prevention benefits of this technology. (Figure Presented) .