New clinical data continues to suggest that left atrial appendage occlusion devices may pose an improvement over warfarin drug regimens for treating patients at increased risk of stroke, researchers reported today.
In presentations during this week’s Heart Rhythm 2014, the Heart Rhythm Society’s 35th Annual Scientific Sessions, researchers presented data comparing LAA devices to treatment with the anti-clotting drug warfarin, the current standard of care.
In a pair of talks about Coherex Medical’s Wavecrest LAA and St. Jude Medical’s (NYSE:STJ) Amplatzer Cardiac Plug, researchers cautiously reported that the devices may be as good as the drug, posing an alternative for patients living with the risks and burdens associated with lifetime anti-coagulation therapy.
Previous studies, including prior HRS presentations about Boston Scientific’s (NYSE:BSX) Watchman device, have found that LAA occluders are as effective as warfarin, with some saying the devices perform even better than the drug.
In order to explore concerns about potential complications during implantation surgeries, one set of researchers looked at acute procedural outcomes in patients receiving Coherex’s Wavecrest device. In a trial of about 70 patients, researchers reported high rates of acute procedural success, sustained LAA closure at 6 weeks and a "manageable" complication rate.
In a separate study, researchers conducted a meta-analysis of 12 trials that spanned nearly 700 patients implanted with the Amplatzer plug, which St. Jude acquired along with AGA Medical for $1.03 billion in 2010. About 97% of patients achieved successful acute LAA closure, with a 2-year composite embolic rate of 2.7%. All-cause mortality was pegged at 3.9%, and cardiovascular mortality was 1.4%, with a patient group aged 68-74.
"LAA closure with the ACP appears to be a safe and feasible alternative to warfarin for preventing thromboembolism in patients with non-valvular [atrial fibrillation]," the researchers concluded.
The authors warned that better studies are needed to better demonstrate the benefits of the devices over anticoagulation drugs, noting that "randomized trial data is lacking for certain LAA closure devices, such as the Amplatzer Cardiac Plug."
In a 3rd poster session, researchers examined the cost implications of treatment with Boston Scientific’s Watchman device, comparing the implant with "all other treatment strategies" for at-risk patients who are also candidates for anti-coagulation drugs.
"LAA occlusion in real world practice substantially reduces costs relative to all other treatment strategies, including clinical trial data of LAA occlusion, over a relatively short time horizon for patients at risk with non-valvular AF," the researchers concluded.
Drug treatment caught up with the higher up-front costs of LAA closure implantation at between 3.5-5.4 years, and the cost savings out to 10 years amounted to a minimum of 75% for LAA closure over other therapies.
The average 10-year cost of the Watchman device was calculated at between about $12,443-$21,761 (£7,337-£12,831), compared with about $24,500 (£14,452) for warfarin in particular.