Procedural success rates associated with the left atrial appendage (LAA) closure device are high, while complication rates are low, according to a new study published in the Journal of the American College of Cardiology.1
Based on the results of 2 randomized trials (PROTECT-AF, ClinicalTrials.gov identifier: NCT00129545 and PREVAIL, ClinicalTrials.gov identifier: NCT01182441) of LAA closure using the Watchman device (Boston Scientific, Inc.; Natick, MA), the US Food and Drug Administration (FDA) approved LAA closure in March 2015 as an alternative to warfarin anticoagulation to decrease stroke risk in patients with nonvalvular atrial fibrillation (AF).2,3 Those findings showed noninferiority of LAA closure to warfarin for the end point of stroke, systemic embolism, or death due to cardiovascular events. In addition, the device was associated with reductions of approximately 80% and >50% in rates of hemorrhagic stroke and cardiovascular death, respectively.
In light of these results, LAA closure has become an important option for stroke prevention, especially for patients in whom long-term anticoagulation is not a feasible option. Although the US Centers for Medicare & Medicaid Services requires patients who have undergone LAA closure to be added to a national registry, most procedures have not been recorded because certification of the first registry did not take place until August 2016. “This is important because it would be expected that the highest complication rate with a novel technology/technique such as LAA [closure] would occur at its initial introduction into clinical practice,” the investigators wrote.
In the present study, the researchers reviewed data collected on all such procedures performed since the date of FDA approval. “In brief, the manufacturer required a clinical specialist to be present at all cases and for procedural parameters and major complications to be collected and reported using a standardized process and forms,” they reported. The investigators’ analysis revealed that:
- LAA closure implantation success was excellent: 95.6% of 3822 consecutive cases.
- The median procedure time was 50 minutes.
- Of the total number of physicians, 29% had performed the procedure in the trials, while 71% were naive to the procedure; the latter group performed 50% of the procedures examined in the current research.
- Complication rates were low: 39 pericardial tamponades (1.02%), 3 procedure-related strokes (0.78%), 9 device embolizations (0.24%), and 3 procedure-related deaths (0.078%).
“Together, these outcomes suggest that the FDA-mandated clinical education program instituted by the manufacturer has been successful in transferring to new operators the various procedural lessons from the years of clinical trials,” the researchers wrote.
Disclosures: Dr Reddy reports receiving research grant support from and has been a consultant for Boston Scientific, Coherex, SentreHeart, and St. Jude Medical. Dr Gibson reports receiving speaker and proctoring fees from SentreHeart and Boston Scientific. Dr Kar reports receiving research grants from Boston Scientific, St. Jude Medical, and Abbott Vascular; is a member of the advisory board for left atrial appendage closure; served as a proctor for Boston Scientific; and is a national principal investigator of the Continuous Access Registries (CAP and CAP2). Dr Doshi reports receiving research grants and consultant fees from Boston Scientific, St. Jude Medical, Coherex, and SentreHeart, and is a national principal investigator of the CAP and CAP2 registries. Dr Horton has received consulting fees from Boston Scientific, and Dr Buchbinder reports receiving grant support from and has been a consultant for Boston Scientific. Nicole T. Gordon is an employee of Boston Scientific.
- Reddy VY, Gibson DN, Kar S, et al. Post-FDA approval, initial US clinical experience with Watchman left atrial appendage closure for stroke prevention in atrial fibrillation. J Am Coll Cardiol. 2017;69(3):253-261. doi:10.1016.j.jacc.2016.10.010
- Reddy VY, Sievert H, Halperin J, et al. Percutaneous left atrial appendage closure vs warfarin for atrial ﬁbrillation: a randomized clinical trial. JAMA. 2014;312(19):1988-1998. doi:10.1001/jama.2014.15192
- Holmes DR, Kar S, Price MJ, et al. Prospective randomized evaluation of the Watchman left atrial appendage closure device in patients with atrial ﬁbrillation vs long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014;64(1):1-12. doi:10.1016/j.jacc.2014.04.029