Safety of Watchman LA Appendage Closure Implantation
What are the procedural outcomes and acute procedure-related complication data for consecutive left atrial appendage closure (LAAC) cases since Food and Drug Administration (FDA) approval?
In the absence of a formal national clinical registry since regulatory approval in March 2015, the investigators obtained procedural data on Watchman implantation procedures. Briefly, every LAAC procedure requires the presence of a manufacturer clinical specialist, and procedural parameter and periprocedural complication data are collected using a standardized process and forms.
In 3,822 consecutive cases, implantation was successful in 3,653 (95.6%) with a median procedure time of 50 minutes (range 10, 210); implanting physicians performing these procedures (n = 382) included 71% new, nonclinical trial implanters, performing 50% of the procedures. Procedural complication rates included: 39 pericardial tamponades (1.02%; 24 treated percutaneously, 12 surgically, and two fatal), three procedure-related strokes (0.078%), nine device embolizations (0.25%; six requiring surgical removal), and three procedure-related deaths (0.078%).
The authors concluded that despite a large fraction of previously inexperienced operators, in the real-world post-FDA approval experience of Watchman LAAC, procedural success was high and complication rates were low.
This post-FDA approval US clinical experience with LAAC using the Watchman device in consecutive patients reported that procedural success was excellent at ~95%, and complication rates were favorable with low rates of pericardial tamponade, procedure-related stroke, and mortality. These outcome data suggest that the FDA-mandated clinical education program instituted by the manufacturer has been successful in transferring to new operators the various procedural learnings from the years of Watchman clinical trials. It should be noted that operators were not required to report procedure-related adverse events that were recognized beyond the procedural period itself (when the clinical specialist was not present), and therefore, complication rates may be underestimated compared with that observed in the clinical trials.
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