The largest study using the Amplatzer Cardiac Plug (St Jude Medical) for left atrial appendage occlusion has shown a high procedural success rate and favourable outcomes for prevention of atrial fibrillation-related thromboembolism.
Apostolos Tzikas (AHEPA University Hospital, Thessaloniki, Greece) and others have recently reported ahead-of-print in EuroIntervention a 97.3% procedural success rate, a 59% annual reduction rate for prevention of atrial fibrillation-related thromboembolism as compared to the rate predicted by the CHA2DS2-VASc score and a 61% annual reduction in major bleeding events as compared to the rate predicted by the HAS-BLED score. The authors also found that periprocedural major adverse events occurred in 4.97% of the patients.
The multicentre, retrospective, observational study included data from 1,047 consecutive patients (mean age 75±8 years) with non-valvular atrial fibrillation who underwent left atrial appendage occlusion with the Amplatzer Cardiac Plug between December 2008 and November 2013 at 22 centres.
Previous observational studies have demonstrated favourable feasibility and safety results with the Amplatzer Cardiac Plug; the aim of this study, according to Tzikas et al, was to “investigate the safety, feasibility and efficacy of left atrial appendage occlusion with the Amplatzer Cardiac Plug in a real-world patient population with atrial fibrillation.”
The authors report that permanent atrial fibrillation was present in 57% of patients and paroxysmal/permanent in 43%. Thirty nine per cent of patients had a history of stroke. The mean CHA2DS2-VASc was 4.5±1.6 and the expected annual risk for thromboembolism (based on the CHA2DS2-VASc score) was 5.7%. The mean HAS-BLED score was 3.1±1.2.
The main indication for left atrial appendage occlusion therapy was previous major bleeding (47%), followed by high risk for bleeding (35%) and coronary stenting mandating triple therapy (22%). In 16% of patients, one of the indications was a stroke on warfarin (or phenprocoumon). The composite of previous bleeding (major or minor) and high bleeding risk was 73%.
There were 52 periprocedural major adverse events reported (eight procedure-related deaths, nine strokes and 13 cardiac tamponades). A peri-device leak was found in 11.6% of the patients; however, the authors note that none of these leaks correlated with any adverse events at follow-up.
Clinical follow-up was complete in 98.2% (1,001/1,019) of the successfully implanted patients and they underwent 13-month follow-up, resulting in a total of 1,349 patient years. One-year all-cause mortality was reported as 4.2%, none of the deaths were attributed to the device, Tzikas et al note. The annual rate of systemic thromboembolism was 2.3% (31/1,349 patient-years), which translates into a 59% risk reduction. The authors also report that the annual rate of major bleeding was 2.1% (28/1,349 patient-years), which shows a 61% risk reduction. They also found that fewer cerebral and fewer bleeding events were seen in patients with single left atrial appendage occlusion on aspirin monotherapy or no therapy and longer follow-up.
“This study reflects the results of left atrial appendage occlusion performed by physicians with different levels of experience and includes every case. In view of this, and taking into account that left atrial appendage occlusion is quite a demanding procedure, the overall success rate is remarkable. One possible reason may be that the Amplatzer Cardiac Plug design, which allows for proximal left atrial appendage avoiding the challenging anatomic variations of left atrial appendage distal parts,” the authors write.
“It should be underlined that well-designed registries and further randomised studies are mandatory in order for left atrial appendage occlusion to be offered to the right patients, meeting the requirements of evidence-based clinical practice,” Tzikas et al conclude.
Tzikas told Cardiac Rhythm News that the treated population in this study is the first large scale representation of what has been documented on the European Society of Cardiology (ESC) atrial fibrillation management guidelines on left atrial appendage occlusion.