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WATCHMAN™

Left Atrial Appendage Closure Device Procedure

 

What is the WATCHMAN™ Left Atrial Appendage Closure Device Procedure?

The Protect AF clinical trial demonstrated the Watchman device is equivalent to Warfarin therapy in reducing strokes in patients with AF. Additionally the Watchman procedure is associated with significantly less long-term complications when compared to patients on drug anticoagulation. In the Protect AF trial, when compared to anticoagulation, the Watchman device reduced cardiovascular and unexplained death by 60% and all cause mortality by 34%.

 

Why WATCHMAN?

WATCHMAN may be a life-changing alternative to the lifelong use of warfarin. In a one-time procedure, WATCHMAN effectively reduces the risk of stroke in people with atrial fibrillation not caused by a heart valve problem.1
As a permanent implant, WATCHMAN doesn’t come with the same bleeding risks associated with the long-term use of warfarin.2 This makes it an important option for people with a history or risk of serious bleeding on blood thinners. Newer blood thinners (also known as novel oral anticoagulant drugs) offer additional options to warfarin, but they don’t take away the long-term risk of bleeding.1

 

Who WATCHMAN Is For?

The WATCHMAN Implant may be right for people who meet the following criteria:
  • They have atrial fibrillation not caused by a heart valve problem (also known as non-valvular AFib)
  • They have been recommended for blood thinning medicines by their doctor
  • They can take warfarin but need an alternative
People may need an alternative to warfarin for any one of these reasons:
  • They have a history of major (serious) bleeding while taking blood thinners
  • They have a lifestyle, occupation, or condition that puts them at risk for major bleeding
  • They take warfarin and have trouble staying within the recommended blood clotting range (a measurement known as INR*) or getting regular blood tests to confirm their INR, and they cannot take a different type of blood thinner
*INR, or International Normalized Ratio, is a measurement of how long it takes for your blood to clot. If you’re out of range, you may be at higher risk for stroke or at higher risk for bleeding.3
As with any medical procedure, there are risks involved with WATCHMAN. See the Important Safety Information below for a list of possible complications, and ask your cardiologist about the risks and benefits of WATCHMAN.
 

Who WATCHMAN Is Not For?

People who should not receive the WATCHMAN Implant include but are not limited to those who:
  • Cannot take warfarin (Coumadin®), aspirin, or clopidogrel (Plavix®)
  • Should not or cannot undergo heart catheterization procedures
  • Have an allergy or sensitivity to nitinol (nickel and titanium) or any of the other materials in the WATCHMAN Implant
  • Have a left atrial appendage that is too large or too small to fit the WATCHMAN Implant
  • Need to take blood thinners for reasons other than AFib stroke risk reduction
Ask your cardiologist if any of these conditions apply to you.
Due to the risk of having a medical procedure, patients should also not be considered for WATCHMAN if they are doing well and expect to continue doing well on blood thinners.

WATCHMAN™ Left Atrial Appendage Closure Device Procedure

Dr. Kashani is one of the first two physicians in Houston certified to perform WATCHMAN™closure procedures.  These procedures help prevent blood clots associated with atrial fibrillation.

This procedure involves the deployment of a “parachute like” stent in the ostium of the left atrial appendage.  The procedure is performed via a single needle stick / IV in the vein of the leg (i.e. femoral vein).  The procedure usually takes less than one hour to complete.

This procedure allows patients with atrial fibrillation to safely come off of (stop) their anti-coagulation.

Experience is key. 

Worldwide experience has repeatedly shown that the Watchman™ Device procedure is safest in the hands of physicians with the greatest experience – both with regards to success of the procedure as well as complications rates.  Dr. Kashani is one of the first two physicians in Houston and one of the first five physicians in all of Texas certified to perform the Watchman procedure.  He was also an investigator in the original clinical trial/registries prior to the approval of the Watchman device by the FDA.   Additionally, Dr. Kashani is a national instructor for new physicians wanting to learn the Watchman procedure.  Dr. Kashani one of the country’s largest Watchman implant volumes.  

While procedural success is 90% in the hands of newly trained/certified physicians, it is greater than 95% nationwide in the hands of more experienced physicians.  To date Dr. Kashani has had a 100% success rate in closing the left atrial appendage with the Watchman device.  Also all trials have shown that complication rates are lower in the hands of physicians with the greatest implant experience.

 
 

References:

  1. Holmes DR Jr, Doshi SK, Kar S, et al. Left atrial appendage closure as an alternative to warfarin for stroke prevention in atrial fibrillation: a patient-level meta-analysis. J Am Coll Cardiol. 2015;65(24):2614-2623.
  2. Price MJ, Reddy VY, Valderrábano M, et al. Bleeding outcomes after left atrial appendage closure compared with long-term warfarin. JACC Cardiovasc Interv. 2015;8(15):1925-1932.
  3. Agency for Healthcare Research and Quality (AHRQ). Blood Thinner Pills: Your Guide to Using Them Safely. http://www.ahrq.gov/sites/default/files/wysiwyg/patients-consumers/diagnosis-treatment/treatments/btpills/btpills.pdf. Published September 2015. Accessed September 8, 2016.
  4. Armstrong S, Amorosi SL, Patel P, et al. An analysis of patient out-of-pocket spending for stroke prevention in non-valvular atrial fibrillation. J Am Coll Cardiol. 2014;63(12_S):A349.