HEARTLINE HSM Genoa Cardiology Meeting - Aristea

PROTECT AF Clinical Trial
Holmes reported promising data from the PROTECT AF Trial. 10 This trial was a prospective,
multicenter randomized trial of percutaneous LAA occlusion vs long-term Warfarin therapy
in patients with non-valvular AF. 11 The WATCHMAN® LAA Closure device (Atritech,
Plymouth, MN, Figure 1), was intended as an alternative to warfarin therapy for patients with
non-valvular AF: the device is designed to prevent embolization of thrombi that may form
in the LAA (Figure 1).
To implant the WATCHMAN ® , the interventional cardiologist guides the device into the heart
through a catheter inserted in a vein in the upper leg. The catheter is threaded rst into the
right atrium, then into the left atrium through a puncture in the wall separating the two
upper chambers of the heart. Once the catheter is positioned in the opening of LAA, the
WATCHMAN is released and left permanently in place to block the formation and release
of blood clots. Eight-hundreds patients were enrolled from Feb 200 to Jun 2008: 6
patients in the device group vs. 2 patients in the control Group in 9 Enrolling Centers
(U.S. & Europe) Follow-up requirements included TEE follow-up at days, 6 months and
1 year; clinical follow-up biannually up to years. Regular INR monitoring while taking
warfarin was mandatrory. 10
Primary Efcacy Endpoint were:
• All stroke: ischemic or hemorrhagic with deficit with symptoms persisting more than
2 hours or symptoms less than 2 hours conrmed by CT or MRI;
• Cardiovascular and unexplained death: sudden death, MI, CVA, cardiac arrhythmia and
heart failure;
• Systemic embolization.
Figure 1
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