Article Text
Abstract
Background Since October 2014, NHS England has approved funding for left atrial appendage occlusion (LAAO) for stroke prevention in patients with atrial fibrillation in 10 UK sites as part of Commissioning through Evaluation (CtE) process. There are no data available on contemporary LAAO practice in the CtE era.
Methods In July 2014, we instituted several processes to ensure compliance with stringent CtE requirements. These included creation of a multidisciplinary team (MDT) that included stroke physicians and non-invasive cardiologists with interest in cardiac imaging, agreement on objective inclusion and exclusion criteria, wide dissemination of these criteria across the cardiac/stroke network, and instituting a dedicated LAAO clinic for patient assessment pre- and post-implant.
Results Between August 2014 and November 2015, 74 LAAO referrals were reviewed at MDT. LAAO was offered to 52/74 (70.3%) patients, of which 42 (56.8%) underwent the procedure, 8 (10.8%) are awaiting it, while 2 (2.7%) declined consent. A decision was taken to treat 14 (18.9%) patients with a novel oral anticoagulant (NOAC) and to maintain watchful waiting in 5 (6.8%). 3 (4.1%) referrals were felt to be inappropriate.
42 patients (mean age 75 ± 9 years, 25 males, median CHA2DS2VASc score 4, median HAS-BLED score 2) underwent LAAO under GA and TOE guidance. The Amplatzer Cardiac Plug was used in the initial 3 cases and Amplatzer Amulet in the remaining 39. Implant was successful in all cases. Mean procedure time was 93 ± 229 min and mean flouro time was 14 ± 88 min. Periprocedural haemorrhage requiring blood transfusion occurred in 2 (4.8%) cases: no other complications were observed. Patients were discharged on a 6-week course of dual antiplatelet therapy, followed by therapy with a single antiplatelet agent.
To date, clinical follow-up is available for 27 patients, while most recent 14 patients are awaiting their first follow up; 1 patient has been lost to follow-up. At mean follow-up of 189 ± 119 days, 25/27 patients (92.6%) are free of haemorrhage or thromboembolic events, 1 patient suffered stroke at 12 months post-LAAO, and 1 patient died 3 weeks after the procedure. 24 patients to date have undergone follow-up imaging, 16 patients are awaiting it, and 1 patient could not tolerate TOE and is awaiting CT. 22 of these 24 (91.6%) patients imaged had good LAA seal with no residual leak, while 2 (8%) had small (<5 mm) leak. 1 patient had evidence of a laminar clot on the device and was started on a NOAC.
Conclusions Contemporary LAAO implant is associated with 100% procedural success, a very low rate of complications and a high rate of LAA seal on follow up imaging. At our centre, the CtE process has been a catalyst for change and has led to streamlining processes along the entire patient journey. With good clinician engagement, it should provide informative real-life data on patient outcomes that could be used to make funding decisions for the wider NHS.
- left atrial appendage
- atrial fibrillation
- stroke