Author + information
- Vivek Reddy1,
- Matthew Price2,
- Miguel valderrabano3,
- Jose Sanchez4,
- Shephal Doshi5,
- Nicole Gordon6 and
- David Holmes Jr.7
- 1Mount Sinai Medical Center, New York, New York, United States
- 2Scripps Clinic, La Jolla, California, United States
- 3Houston, Texas, United States
- 4The Heart Health Center, Saint Louis, Missouri, United States
- 5Pacific Heart Institute, Santa Monica, California, United States
- 6Boston Scientific, St. Paul, Minnesota, United States
- 7Mayo Clinic, Rochester, Minnesota, United States
Left atrial appendage closure (LAAC) with the Watchman Device (Boston Scientific, MN) is an alternative to warfarin for stroke risk reduction in high risk non-valvular atrial fibrillation (NVAF) patients. This analysis presents the most updated clinical event rates over the longest course of follow-up for the 2 randomized clinical trials: PROTECT AF (5 yrs) and PREVAIL (3 yrs).
LAAC clinical event rates and stroke outcomes were from pooled PROTECT AF 5-year and PREVAIL 3-year patient-level data were aggregated and analyzed on an intent-to-treat basis.
The baseline risk of stroke for the732 device patients included in the analysis was 3.6% based on a medican CHA2DS2-VASc score of 3.4. Procedural complications included effusion (4.4%), major bleeding (2.3%), stroke (1.0%), and device embolization (0.5%). Rate Ratios for ischemic stroke, hemorrhagic stroke, and major bleeding post-procedure were 1.35, 0.16, and 0.62, respectively. Among patients who suffered a stroke in the device group, Modified Rankin Scores (MRS) were 75.8% (0-2), 3.0% (3), 15.2% (4-5), and 6.1% (6).
Using the combined randomized clinical data, along with increased follow-up, provides the most complete evaluation of WATCHMAN efficacy. Consistently low rates of events, comparable to those expected with anticoagulation in this high risk population, support an LAAC therapy strategy for stroke risk reduction in NVAF patients.
STRUCTURAL: Left Atrial Appendage Exclusion