Black Hills Cardiologists Reducing Stroke Risk with Blood Thinner Alternative
Nov 27, 2017 03:01PM ● Published by Alex Strauss
By: Alex Strauss
A lifetime of blood thinners - and the risks associated with them - is no longer the only option for for Black Hills area patients diagnosed with non-valvular atrial fibrillation.
Rapid City cardiologists Joseph Tuma, MD, and Jose Teixeira, MD, have begun offering an implantable device called Watchman to qualified patients who want or need an alternative to long-term blood thinner use.
The tiny device covers the mouth of the left atrial appendage which, according to Dr. Tuma, is the source of blood clots in 90 percent of patients who suffer from cardioembolic complications of atrial fibrillation.
Using a combination of fluoroscopy/angiography and transesophageal echo for guidance, the device is implanted percutaneously through a small puncture in the right femoral vein followed by a puncture through the interatrial septum. It takes about 45 days for the area to be sealed completely off from the rest of the left atrium.
“By plugging the left atrial appendage, the Watchman device prevents ejection of clots into the circulating bloodstream, thereby reducing the risk of stroke,” Dr. Tuma tells MED.
“The prevention of strokes is the same as if the patient of continuously on a blood thinner like coumadin,” adds Dr. Teixeira. “But unlike the anticoagulants which only work in the patients take them, the Watchman device, once implanted, is good for the long run with no other maintenance required.”
While the device is not an option for people who have already had clots inside the left atrial appendage or those who are unable to take a blood thinner for at least the 45 days needed for the seal to form, it may be ideal for those at higher risk of bleeding or who have already bled.
Five year data on Watchman presented at the TCT Conference in Denver last month suggests that patients with implants not only have a stroke risk comparable to those on warfarin, but showed a 55 percent lower risk of hemorrhagic stroke. According to Dr. Tuma, “The ideal patient for the Watchman device is someone with nonvalvular atrial fibrillation with a CHADS2Vasc score of 3 or greater, placing them at increased risk of stroke, who has experienced difficulty with anticoagulation either because of bleeding episodes, intolerance, or inconsistent therapeutic anticoagulation.”
Watchman is typically covered by insurance for patients who meet the criteria. A budget impact study also presented at the TCT conference showed that, at ten years, left atrial appendage closure with Watchman was less costly than with warfarin or non non-warfarin anticoagulants.
“The long-term cost is favorable because there are no tests or other maintenance required once the device is deployed,” says Dr. Teixeira.
More from our interviews with Drs. Joseph Tuma and Dr. Jose Teixeira:
1. Can you summarize how the Watchman device works? How does it reduce the risk of stroke?
Dr. Tuma: The Watchman device works by occluding the left atrial appendage, which is the source of thrombus in >90% of patients who suffer from cardioembolic complications of atrial fibrillation. This is done percutaneously through a small puncture in the right femoral vein followed by transseptal puncture through the interatrial septum. The procedure is guided by a combination of fluoroscopy/angiography and transesophageal echo. By plugging the left atrial appendage, the Watchman device prevents ejection of clots into the circulating bloodstream, thereby reducing the risk of stroke.
Dr. Teixeira: The Watchman device covers the ostium (mouth) of the Left Atrial Appendage and with time usual in 45 days will seal it completely from the rest of the Left atrium (The left upper chamber of the heart) preventing blood from entering this appendage (where clots are formed in atrial fibrillation). The prevention of strokes is the same as if the patient was continuously on a blood thinner like coumadin (Warfarin). Unlike the anticoagulants (blood thinners) that only work if patients take them the Watchman device once implanted is good for the long run with no other maintenance required.
2. When is Watchman preferable to blood thinners? Are there cases in which you would not use it and why?
Dr. Tuma: The Watchman device is an alternative to blood thinners in patients with non-valvular atrial fibrillation at elevated risk of stroke who are candidates for short-term anticoagulation (6 weeks) but who wish to seek a nonpharmacologic alternative to long-term therapy. Common examples would be patients with a history of bleeding on anticoagulation, patients who are at elevated risk of bleeding such as people with a history of recurrent falls, or those who have experienced drug–drug interactions with 1 of their anticoagulants.
The Watchman device should be avoided in patients who have an allergy to nickel or titanium, as the frame of the device is a nickel titanium alloy (nitinol). If there is visible thrombus in the left atrium or left atrial appendage, this would also be a contraindication to implantation. Additionally, if the patient is unable to take short-term anticoagulation or has a serious allergy to warfarin, Plavix, or aspirin, implantation of the device should be avoided.
Dr. Teixeira: The watchman is preferred to blood thinners in any patients who are at high risk of bleeding or who have already bled .The most serious bleeds are intracranial (inside the brain) inside the eyes leading to blindness and GI (gastrointestinal ) and hematuria (blood in the urine).
Not everybody is a candidate for the device.People who have already clots present inside the left atria appendage, people who can not take a blood thinner for at least 45 days for example are not candidates for the Watchman.
3. Who is the ideal candidate for this device?
Dr. Tuma: The ideal patient for the Watchman device is someone with nonvalvular atrial fibrillation with a CHADS2Vasc score of 3 or greater, placing them at increased risk of stroke, who has experienced difficulty with anticoagulation either because of bleeding episodes, intolerance, or inconsistent therapeutic anticoagulation. Patient's who are increased risk of potentially life-threatening bleeding would also be good candidates. A common example would be patients with neuromuscular disorder such as Parkinson's disease who have a history of falling.
Dr. Teixeira: The ideal candidate is a person with nonvalvular atrial fibrillation with a CHADSVASC score of 3 or higher (high risk of stroke) who are at high risk of bleeding or already bled on a blood thinner. Patients who want to participate in contact sports, or engage in sports that carry risk of falls or other trauma.
4. Are there contraindications?
Dr. Teixeira: The device is contraindicated in people who have clots inside the heart and people who can not take a blood thinner for a short term minimum 45 days.
5. What is the long term outlook for patients who have this device? Do we have any longer term study results yet?
Dr. Teixeira: The long term outlook is great. We now have data up to 5 years showing continues protection.
Dr. Tuma: In late October 2017, the five-year data from the PROTECT and PREVAIL trials was presented at the TCT Conference in Denver, CO. In summary, patients who underwent Watchman implantation had a very low risk of stroke over a five-year period. The risk was similar to those patients treated with warfarin. However, the safety profile of the patient to underwent Watchman implantation showed significant benefit over warfarin, with a 55% reduction in hemorrhagic stroke, which is often devastating and is associated with severe neurologic impairment and/or death.
6. Does insurance cover this procedure? How does the cost compare to alternatives (i.e., a lifetime of blood thinners?)
Dr. Teixeira: Medicare and private insurers cover the procedure. The long term cost is favorable because there are no tests or other maintenance required once the device is deployed.
Dr. Tuma: The device is covered by insurance and Medicare when all criteria are met. Specifically, this means the etiology of the atrial fibrillation needs to be nonvalvular. Patient's need to be at increased risk of cardioembolic stroke, defined as a CHADS2Vasc score of 3 or greater. Also, there needs to be documentation of a shared decision making process between the patient and a non-implanting physician such as a referring cardiologist or a referring primary care provider. Finally, the patient needs to be a candidate for short-term anticoagulation therapy (6 weeks) to allow for healing of the device, and the device has to be implanted by Cardiologists and/or Cardiac Surgeons who meets the minimum requirements for structural heart interventions.
At the TCT conference in October, a budget impact study of the Watchman device exploring straight cost differences between device implantation, warfarin, and non-warfarin oral anticoagulants was presented. It turns out that appendage closure with Watchman is significantly cheaper to the overall health system, and is also cheaper to the patient. At 5 years, the device remained more expensive than warfarin therapy by about $10,000 as far as Medicare costs are concerned. There was a significant reduction in cost when device implantation was compared with use of the non-warfarin oral anticoagulants. Additionally, when looking at the cost to the patient, at 5 years there was about a $2500 cost savings for patients who underwent Watchman implantation compared to Coumadin, and a $6000 savings when compared to use of the non-warfarin oral anticoagulants. At 10 years, left atrial appendage closure with Watchman device was found to be the least costly alternative to the healthcare system as a whole, at $34,000 versus $40,000 with warfarin and $66,000 with the novel non-warfarin anticoagulants.