Original Title: Percutaneous Left Atrial Appendage Closure with the Watchman Device Long-Term Results Up to 5 Years. Reference: Wiebe J, Franke J, Lehn K et al. JACC Cardiovascular Interventions Vol. 8, NO. 15, 2015 Doi: 10.1016/j.jcin.2015.07.040

Courtesy of Dr. Agustín Vecchia.

Atrial fibrillation (AF) is one of the most predominant arrhythmias and is associated to cardioembolic ischemic events (especially, stroke). Left appendage closure (LAA) is an alternative to reduce these events in patients with high risk of bleeding or contraindication to anticoagulants, since 90% of thrombi are originated by LAA. A few months ago (March 2015) the FDA approved the use of the Watchman device for LAA closure in patients with nonvalvular AF to reduce cardioembolic risk.

The present study evaluates 5 year outcomes in patients with atrial fibrillation undergoing LAA closure with the Watchman device. In included 102 consecutive patients from one center alone, with CHADS2 or CHA2DS2-VASc scores of 1 undergoing LAA closure with Watchman between 2006 and 2010. Patients were followed up at 45 days, 3 months, 6 months and one year, and thereafter, annually.

The mean age was 71.6 ± 8.8 years, and 37.3% were women. The mean CHADS2 and CHA2DS2-VASc scores were 2.7 ± 1.3 and 4.3 ± 1.7, respectively. Procedural success was achieved in 96.1% of patients. During a mean follow-up period of 3.0 ± 1.6 years, the annual rates of transient ischemic attack, stroke, intracranial hemorrhage, and death were 0.7%, 0.7%, 1.1%, and 3.5%, respectively.

Conclusion
The use of Watchman is safe and effective in the long term to prevent stroke in patients with chronic, nonvalvular AF.

Editorial Comment
– Tow randomized studies (PROTECT AF and PREVAIL) showed that the Watchman device is a safe and effective alternative for patients with contraindication to anticoagulants.
– Experienced operators will have a high percentage of procedural success.
– In the present registry, there were complications in 8.8% of patients: 3 pericardiocentesis and 4 strokes with no hemodynamic compromise. The complications rate saw no differences between the first and second cohorts, which differs from other studies, even though this may be due to the low events rate.
– Bear in mind that a 25.6% of patients required device recapture and repositioning and that 31.4% required replacement for a different size.
– Finally: according to the present guidelines, patients should receive anticoagulants for 45 days after procedure. Only 58.2% of this cohort received anticoagulants and there were no differences in complications rate with the 41.8% that did receive anticoagulants (again, we should note that there was a small number of events, but similar observation of the ASAP trial, that included patients with contraindication to anticoagulants, support this hypothesis).

Courtesy of Dr. Agustín Vecchia.