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Now that the Watchman device for left atrial appendage closure is on the U.S. market, target patients are those with atrial fibrillation who can tolerate at least a brief, 6-week course of treatment with warfarin – which is what the device’s labeling demands – but are poor candidates for long-term treatment with oral anticoagulation because they have had a serious bleeding episode while on anticoagulant treatment, Dr. Vivek Y. Reddy said in an interview.
Another type of atrial fibrillation patient who is potentially a prime target for Watchman placement are those with a complete contraindication to warfarin treatment, but as of now this makes then ineligible to receive the device. This category of patient will be the target of the ASAP 2 trial, a large, multicenter trial planned to start by the end of 2015 that will randomize atrial fibrillation patients ineligible to receive any oral anticoagulation to receive Watchman followed by a 6-month period of dual antiplatelet therapy or to current standard therapy for such patients with aspirin alone, said Dr. Reddy, professor of medicine and director of the cardiac arrhythmia service at Mount Sinai Hospital in New York.
The ASAP 2 trial follows the pilot study ASAP (ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology) that Dr. Reddy led and ran at four centers in Europe placing Watchman in patients ineligible to receive any oral anticoagulant treatment followed by 6 months of dual antiplatelet therapy. The ASAP results showed that this approach could be safe and effective (J Am Coll Cardiol. 2013 Jun 25;61[25]:2551-6.).
Patients with a total contraindication against treatment with warfarin or another oral anticoagulant “have the greatest need,” said Dr. Reddy. “The problem is we don’t have much safety data” for these patients, and while the results from the ASAP trial showed the device can be safely placed just using dual antiplatelet therapy the numbers were small and the device is not approved for use in this setting, he said.
Dr. Reddy has been an advisor to and received research grants from Atritech/Boston Scientific, the companies that developed and now market Watchman.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
Now that the Watchman device for left atrial appendage closure is on the U.S. market, target patients are those with atrial fibrillation who can tolerate at least a brief, 6-week course of treatment with warfarin – which is what the device’s labeling demands – but are poor candidates for long-term treatment with oral anticoagulation because they have had a serious bleeding episode while on anticoagulant treatment, Dr. Vivek Y. Reddy said in an interview.
Another type of atrial fibrillation patient who is potentially a prime target for Watchman placement are those with a complete contraindication to warfarin treatment, but as of now this makes then ineligible to receive the device. This category of patient will be the target of the ASAP 2 trial, a large, multicenter trial planned to start by the end of 2015 that will randomize atrial fibrillation patients ineligible to receive any oral anticoagulation to receive Watchman followed by a 6-month period of dual antiplatelet therapy or to current standard therapy for such patients with aspirin alone, said Dr. Reddy, professor of medicine and director of the cardiac arrhythmia service at Mount Sinai Hospital in New York.
The ASAP 2 trial follows the pilot study ASAP (ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology) that Dr. Reddy led and ran at four centers in Europe placing Watchman in patients ineligible to receive any oral anticoagulant treatment followed by 6 months of dual antiplatelet therapy. The ASAP results showed that this approach could be safe and effective (J Am Coll Cardiol. 2013 Jun 25;61[25]:2551-6.).
Patients with a total contraindication against treatment with warfarin or another oral anticoagulant “have the greatest need,” said Dr. Reddy. “The problem is we don’t have much safety data” for these patients, and while the results from the ASAP trial showed the device can be safely placed just using dual antiplatelet therapy the numbers were small and the device is not approved for use in this setting, he said.
Dr. Reddy has been an advisor to and received research grants from Atritech/Boston Scientific, the companies that developed and now market Watchman.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
Now that the Watchman device for left atrial appendage closure is on the U.S. market, target patients are those with atrial fibrillation who can tolerate at least a brief, 6-week course of treatment with warfarin – which is what the device’s labeling demands – but are poor candidates for long-term treatment with oral anticoagulation because they have had a serious bleeding episode while on anticoagulant treatment, Dr. Vivek Y. Reddy said in an interview.
Another type of atrial fibrillation patient who is potentially a prime target for Watchman placement are those with a complete contraindication to warfarin treatment, but as of now this makes then ineligible to receive the device. This category of patient will be the target of the ASAP 2 trial, a large, multicenter trial planned to start by the end of 2015 that will randomize atrial fibrillation patients ineligible to receive any oral anticoagulation to receive Watchman followed by a 6-month period of dual antiplatelet therapy or to current standard therapy for such patients with aspirin alone, said Dr. Reddy, professor of medicine and director of the cardiac arrhythmia service at Mount Sinai Hospital in New York.
The ASAP 2 trial follows the pilot study ASAP (ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology) that Dr. Reddy led and ran at four centers in Europe placing Watchman in patients ineligible to receive any oral anticoagulant treatment followed by 6 months of dual antiplatelet therapy. The ASAP results showed that this approach could be safe and effective (J Am Coll Cardiol. 2013 Jun 25;61[25]:2551-6.).
Patients with a total contraindication against treatment with warfarin or another oral anticoagulant “have the greatest need,” said Dr. Reddy. “The problem is we don’t have much safety data” for these patients, and while the results from the ASAP trial showed the device can be safely placed just using dual antiplatelet therapy the numbers were small and the device is not approved for use in this setting, he said.
Dr. Reddy has been an advisor to and received research grants from Atritech/Boston Scientific, the companies that developed and now market Watchman.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
