NCA - Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG-00445N) (2024)

Filart, RolandTitle: MD
Organization: Healthchoice PPO
Date: 12/10/2015
Comment:

To whom it may concern,

I am a practicing electrophysiologist with the Orlando Heart Center since 1997. I primarily practice at The Orlando Regional Medical Center (ORMC) and Orlando Health Heart Institute (OHHI). These institutions have a very robust Atrial Fibrillation Center, certified by the Society of Chest Pain Centers and winner of the 2015 Bronze Award from the American Heart Association -Get With the Guidelines Program. ORMC was recognized by the AHA 2014-2015 as one of the

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Joshi, RajeevTitle: MD
Organization: North Texas Heart Center, Dallas
Date: 12/10/2015
Comment:

The potential impact of this device on several of my patients can be very useful and helpful. The patient with high stroke risk, who has a low HAS-BLED score, but indeed has had a significant bleed, and likely is at risk for another bleed, and worries all the time about either having a stroke or having a bleeding problem, can be benefitted very much with this device, especially if they have had cardiac surgery, and epicardium is not accessible.

Limiting the costs is a real goal,

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Wissner, ErikTitle: Consultant
Organization: Consultants in Cardiology and Electrophysiology
Date: 12/10/2015
Comment:

Dear Ms. Syrek-Jensen,

I would like to comment on the proposed national coverage decision to cover percutaneous LAAC therapy using the Watchman device. We are a tertiary hospital in Illinois with a busy electrophysiology program and many patients suffering from atrial fibrillation in dire need for alternatives to anticoagulation therapy using NOACs or Warfarin. I began implanting Watchman devices in 2013 in Germany where the Watchman device has been available for over 2 years. I

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Ziv, OhadTitle: Director, cardiac electrophysiology
Organization: Metrohealth Medical Center
Date: 12/10/2015
Comment:

National coverage for LAAC is an important step to improving the care and outcomes of patients with NVAF in the US. Please consider the following points:

1- FDA indication of watchman is for patients who are able to take Anticoagulation. CMS coverage policy should reflect this.

2- risk and benefit of anticoagulation versus watchman is a complex decision making process that is best left to the clinician and patient. Mandating a chads-vasc score consistent with a clinical

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Choudry, SubbaraoTitle: Asst Clinical Professor
Organization: Mount Sinai Hospital
Date: 12/10/2015
Comment:

While I commend the proposal for national coverage of Watchman procedures, I agree with many of the commenters that the proposed conditions for use are overly restrictive and are often at odds with the studied (and FDA-approved) use of the Watchman device. I am a practicing cardiac electrophysiologist who sees patients both at a large academic medical center and in the more rural suburbs.
The proposed conditions for coverage are ambiguous and may leave many patients with relative

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Pratsos, AntonisTitle: MD
Organization: Bryn Mawr Hospital
Date: 12/10/2015
Comment:

I am an interventional cardiologist in private practice and together with an electrophysiologist, i have performed 10 watchman procedures since the device was approved for use. Every case was performed carefully and methodically and none of them have had any complications. All cases had successful LAA closure. The device is major advance in the prevention of stroke in patients with AF. Since the device was approved in patients with CHADSVASC2 score>2 who can tolerate warfarin for 45 days post

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Hinderliter, AlanTitle: Associate Professor of Medicine
Organization: University of North Carolina
Date: 12/10/2015
Comment:

The proposed decision memo for percutaneous LAA Closure Therapy is a thoughtful document that, for the most part, outlines reasonable criteria for coverage of this novel form of therapy.

Condition 2 deserves some clarification:
a) It is not clear what constitutes a "high CHADS2 or CHADS-Vasc score". Perhaps the criterion utilized in the PROTECT-AF trial (CHADS score of 1 or greater) should be adopted.
b) Similarly, it is not clear what constitutes a "high HAS-BLED score",

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El-Chami, MikhaelTitle: MD
Organization: Emory University
Date: 12/10/2015
Comment:

To whom it may concern,
I am the director of electrophysiology at Emory University Hospital Midtown and a practicing electrophysiologist at Emory Healthcare. I have been treating patients with non-valvular atrial fibrillation since 2008. I have used the Watchman technology as part of clinical trials and commercial setting. I appreciate the opportunity to comment on a well-designed national coverage decision. I specifically would like to comment on the 2nd condition:
A high CHADS

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Yakubov, StevenTitle: MD
Organization: OhioHealth Riverside Methodist Hospital
Date: 12/10/2015
Comment:

To: Tamara Syrek-Jensen, J.D., (Director of Coverage & Analysis Group)

I am an interventional cardiologist in Columbus, Ohio. I practice clinical cardiology, as well as perform PCI/stents, TAVR, mitraclip and left atrial appendage closure procedures. I practice at Riverside Methodist Hospital (part of the OhioHealth system), which is a large community teaching institution. I am active in clinical research and teaching residents.

I have been very active in clinical

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Smalling, RichardTitle: Director of Interventional Cardiovascular Medicine
Organization: UTHealth, Memorial Hermann Heart and Vascular Institute-TMC
Date: 12/10/2015
Comment:

I am an Interventional Cardiologist who specializes in structural heart disease. I have been performing interventions in the left atrium for mitral valve disease and ASD closure for over 30 years. I have recently begun LAA exclusion procedures for patients with atrial fibrillation who are at high risk for bleeding complications from oral anticoagulants.

This population is typically comprised of elderly patients with fall risks but may also include younger patients with jobs

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John, BenjaminTitle: MD
Organization: The Vancouver Clinic
Date: 12/10/2015
Comment:

I am a clinical cardiac electrophysiologist currently practicing in Vancouver, Washington as part of a multi-specialty group The Vancouver Clinic for which a majority of my clinical practice is devoted to the management of atrial fibrillation. I will have on a daily basis conversations with my patients with atrial fibrillation about stroke prevention and attempt to present a balance argument for the type of prevention needed based on the individual risks and goals of therapy. What has been

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Gibson, DouglasTitle: MD
Organization: Scripps Clinic
Date: 12/10/2015
Comment:

I am an Electrophysiologist directly involved in the care of patients at risk for stroke related to atrial fibrillation. I have cared for these patients for many years both with and without LAAC therapy. Personally, I have cared for patients that have been hospitalized for prolonged periods of time or passed away because of bleeding complications related to oral anticoagulants. I have also cared for patients that have suffered devastating stroke because of the fact that they were not good

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Reich, StephenTitle: Cardiac Electrophysiologist
Organization: Baptist Health System
Date: 12/10/2015
Comment:

Hello,
I wanted to send a brief comment relating to the LAA closure therapy decision. Many patients in my practice with atrial fibrillation and at an increased risk for stroke are limited in their options for oral anticoagulant therapy. They are either unable to control their Coumadin levels or are unable to make it in for INR checks. They may also be financially limited and are thus essentially ruled out for the novel oral anticoagulants. Though they do not have a physical

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Zellner, ChristianTitle: Interventional Cardiologist
Organization: Springfield Clinic
Date: 12/10/2015
Comment:

Public Comment on CMS Proposal

I am an Interventional Cardiologist in a large Multi Speciality Group in Illinois. I believe the Watchman device is effective, safe, and backed by solid scientific data. The device is routinely used outside the USA and appropriately received FDA approval after almost a decade of randomized studies.

The proposal contains guidance on physician documentation and consent, as well as registry requirements that are appropriate for this

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Abdul Karim, AhmadTitle: Medical Director, Cardiac Electrophysiology
Organization: St Joseph Medical Center, Presence Health
Date: 12/10/2015
Comment:

Dear Ms. Syrek-Jensen

I am an electrophysiologist who is treating patients suffering from atrial fibrillation on a daily basis. Atrial fibrillation is the most common cardiac arrhythmia in clinical practice. Affected patients are at increased risk for thromboembolic events. Anticoagulation therapy has proven to be effective in preventing further events in patient with atrial fibrillation and high CHADS2VASC score. Unfortunately, significant number of these patients are not on

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Ludmer, PaulTitle: Electrophysiologist, MD, FACC
Date: 12/10/2015
Comment:

RE: Percutaneous Left Atrial Appendage (LAA) Closure Therapy

Dear Ms. Syrek-Jensen,

I am an Electrophysiologist in the San Francisco East Bay affiliated with multiple hospital networks in the area. The treatment of patients with atrial fibrillation remains one of the most important parts of my practice, and the Watchman device, as well as the appropriate coverage of this device, remains an important topic of discussion with my patients. The discussion points below were my

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Hasan, SyedTitle: MD
Organization: Valley Cardiology
Date: 12/10/2015
Comment:

To Whom it May Concern:

I am an interventional and general cardiologist dealing with a large number of patients who suffer from chronic atrial fibrillation. In our aging population, long term anticoagulation is many times difficult due to significant risk of bleeding or falls. These patients are often treated suboptimally by having their anticoagulation stopped or they are put at high risk for bleeding by having their anticoagulation continued. Left atrial appendage

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Lin, AlbertTitle: Associate Professor
Organization: Northwestern University-Bluhm Cardiovascular Institute
Date: 12/10/2015
Comment:

Dear Ms. Syrek-Jensen:

I am a clinical cardiac electrophysiologist at Northwestern Memorial Hospital who has implanted the Watchman device in the Prevail trial, the CAP registry, and after FDA approval of the Watchman device. However, our ability to implant the Watchman LAA occlusion device for patients in desperate need of therapy to prevent strokes or systemic embolism (SSE) in non-valvular AF (NVAF) has been greatly hampered by a LCD covering Illinois that has not granted

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Shukla, GunjanTitle: Director, Atrial Fibrillation Center
Organization: Hackensack University Medical Center
Date: 12/10/2015
Comment:

To: Ms. Tamara Syrek-Jensen, J.D., Director of Coverage & Analysis Group

Dear Ms. Syrek-Jensen:

Thank you for the opportunity to comment on the proposed decision for percutaneous left atrial appendage closure (CAG-00445N). We have reviewed the seven conditions detailed and would like to propose some comments below.

We commend the Centers for Medicare and Medicaid Services (CMS) for their detailed consideration of coverage for percutaneous left atrial appendage

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Patel, ParasharTitle: VP, Global Health Economics & Reimbursem*nt
Organization: Boston Scientific Corporation
Date: 12/10/2015
Comment:

December 10, 2015

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C1-09-06
7500 Security Blvd
Baltimore MD 21244

RE: Proposed Medicare Coverage Decision Memorandum for Percutaneous Left Atrial Appendage Closure (LAAC) Therapy (CAG-00445N)

Dear Ms. Syrek Jensen:

We are pleased that CMS is proposing

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Reddy, VivekTitle: Director, Cardiac Arrhythmia Service
Organization: Mount Sinai School of Medicine
Date: 12/10/2015
Comment:

December 10, 2015

Ms. Tamara Syrek-Jensen, JD
Director of Coverage & Analysis Group

Joseph Chin, MD, MS
Deputy Director, Coverage and Analysis Group

Lori Ashby, MA
Director, Division of Medical and Surgical Services

Kimberly Long
Lead Analyst

Jyme Schafer, MD, MPH
Lead Medical Officer

Rosemarie Hakim, PhD
Epidemiologist

Re: CMS Proposed Coverage Decision for Percutaneous Left Atrial Appendage

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Goldner, BruceTitle: MD
Organization: Northwell
Date: 12/10/2015
Comment:

1] There needs to be clarification about how we are going to use CHADS2vasc and HAS BLED. Also the condition that warfarin is contraindicated does not make sense, since patients have to be on warfarin for at least 45 days post Watchman. A better way of stating the warfarin condition is that the patient is at high risk of bleeding based upon previous history (i.e. history of GI, GU, intra-articular, intra-ocular or cutaneous bleeding), risk of fall/trauma, or high HASBLED score. Indication

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Nguyen, DuyTitle: MD, Assistant Professor of Medicine
Organization: University of Colorado
Date: 12/10/2015
Comment:

It is not clear what "contraindications to warfarin" means as per FDA labeling for this device and per all the research, patients have to be able to take warfarin but have a reason to seek an alternative. The NCD and the FDA label for this device do not appear consistent. We need clarification in terms of coverage for those patients in whom warfarin is not contraindicated but patients remain at high risk of stroke and of bleeding, and have a reason to seek an alternative, which is what the

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McCullough, CassandraTitle: CEO
Organization: Association of Black Cardiologists
Date: 12/10/2015
Comment:

December 9, 2015

Ms. Tamara Syrek-Jensen, J.D.
Director, Coverage & Analysis Group, OCSQ
Centers for Medicare and Medicaid Services
7500 Security Boulevard, C1-14-15
Baltimore, Maryland 21244

A FORMAL NATIONAL COVERAGE DETERMINATION (NCO} REQUEST FOR PERCUTANEOUS, TRANSCATHETER, INTRALUMINAL LEFT ATRIAL APPENDAGE CLOSURE (LAAC} WITH IMPLANTED DEVICE

Dear Ms. Syrek-Jensen:

The Association of Black Cardiologists (ABC) would

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Leahey, MarkTitle: President & CEO
Organization: Medical Device Manufacturers Association (MDMA)
Date: 12/10/2015
Comment:

December 10, 2015

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C1-09-06
7500 Security Blvd
Baltimore MD 21244

RE: Proposed Medicare Coverage Decision Memorandum for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG-00445N)

Dear Ms. Syrek Jensen:

On behalf of the Medical Device

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Alvarez, JorgeTitle: MD
Organization: Cardiology Clinic of San Antonio
Date: 12/10/2015
Comment:

Dear Ms. Tamara Syrek-Jensen,J.D.

On behalf of the physicians and patients I care for at Methodist Hospital in San Antonio,Texas and South Texas, I would like to take this opportunity to comment on CMS's Proposed Coverage Decision for Percutaneous Left Atrial Appendage Closure using the Watchman device. I have been personally involved with this device for now for 1 year, having implanted my first Watchman in early 2015 once comerciallization was approved. I have implanted several

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Dukkipati, SrinivasTitle: Director, Electrophysiology Lab
Organization: Mount Sinai Medical Center
Date: 12/10/2015
Comment:

I am a cardiac electrophysiologist with experience in treating nonvalvular AF patients who are at risk for stroke. I also have performed numerous percutaneous left atrial appendage closure procedures in such patients.

As a physician that practices evidence based medicine, I cannot understand the rationale for basing coverage on patients being contraindicated to warfarin therapy. The Watchman trials (PROTECT AF, PREVAIL, etc.) have all included patients who are eligible for

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Miller, MarcDate: 12/10/2015
Comment:
I believe that the CMS coverage should reflect the patient population in the randomized trials (an alternative to warfarin therapy). I also do not find the HAS-BLED score to be too clinically useful, and I rarely incorporate into my clinical practice. I do not believe it should be used within the context of deciding who is appropriate for left atrial appendage occlusion.Girado, HaroldTitle: Vice President
Organization: Baptist Hospital Miami
Date: 12/10/2015
Comment:

To Whom It May Concern:

Leadership within the Baptist Health South Florida health-system have been informed of the Centers for Medicare and Medicaid Services (CMS) decision to decline coverage of percutaneous left atrial appendage closure (LAAC) therapy—including the Watchman device. As a healthcare entity that is expanding our clinical services and endeavoring to continue a reputation of cutting-edge treatment options for patients in South Florida and beyond, Baptist Health has

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Koruth, JacobTitle: Asst Professor
Organization: Mt Sinai Medical Center, NewYork
Date: 12/10/2015
Comment:

My name is Jacob Koruth and I practice electrophysiology at Mount Sinai Hospital in New York City. I am writing to support approval of the National Coverage Determination for the WATCHMAN left atrial appendage device. I am happy to see the proposal by CMS to provide coverage for the WATCHMAN procedure. This device represents a first of its kind alternative treatment for patients with non-valvular atrial fibrillation who are at high risk of thromboembolic events, but who are not good

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Jayaram, KiranTitle: Electrophysiologist
Date: 12/10/2015
Comment:

To CMS

I am a practicing Electrophysiologist in San Antonio, TX. As a full time Electrophysiologist, a large percentage of my practice is devoted to taking care of patients with atrial fibrillation. One of the most catastrophic complications of atrial fibrillation is CVA. Patients with CHADS-VASC score >= 2 are deemed to be high risk for CVA and data suggests the anticoagulation is warranted. Many of these patients are taking Coumadin or one of the new NOAC agents (Pradaxa,

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Cuoco, FrankTitle: MD
Organization: MUSC, Charleston, SC
Date: 12/10/2015
Comment:

As an electrophysiologist who treats thousands of patients with atrial fibrillation per year, the FDA approval of LAAC was extremely important and impactful for our practice as the only academic medical center in the state of SC. Patients clearly need an alternative to OAC, and LAAC is the best studied alternative, providing for better safety and outcomes compared to Warfarin therapy.

The CMC coverage decision is equally important, as it will dictate if many of our patients

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Goodwin, MarkTitle: Chief of Cardiology
Organization: Edward Heart Hospital/ Advocate Medical Group
Date: 12/10/2015
Comment:

I am writing in full support of a national coverage decision for the Watchman device.The data from PREVAIL and ATTRACT trial show comparable effectiveness for stroke prevention with significant decreased bleed rates. Unfortunately those patients with the highest benefit of anticoagulation therapy for atrial fibrillation are also frequently those at highest risk for anticoagulation. Just this week 3 patients were admitted with major complications from warfarin therapy...intacranial bleed, and 2

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Lim, MichaelTitle: Director of Cardiology
Organization: Saint Louis University
Date: 12/10/2015
Comment:

As a practicing interventional cardiologist, I welcome the opportunity to wholeheartedly support the coverage of this technology! The Watchman device, with years of clinical investigation involving long-term patient followup, allows us to potentially make a significant impact on reducing stroke in patients with atrial fibrillation. Many of our patients or even their primary care colleagues appreciate the impact of atrial fibrillation, but all seemingly would like to avoid a stroke if

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Goswami, NileshTitle: Director, Cardiac Catheterization Laboratory
Organization: Prairie Cardiovascular Consultants, Ltd.
Date: 12/10/2015
Comment:

I appreciate the opportunity to comment on the proposed CMS coverage decision on the Watchman device. The safety and efficacy of this technology has been established and summarized in previous clinical trial data and has been outlined in previous comments.

As our population grows older, the numbers of frail, elderly patients with poor gait stability and atrial fibrillation continues to grow. Anticoagulation in this population is clearly a concern with regards to bleeding and

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Blankenship, James C.Title: President
Organization: Society for Cardiovascular Angiography and Interventions (SCAI)
Date: 12/10/2015
Comment:

December 10, 2015

Ms. Tamara Syrek-Jensen
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed National Coverage Decision (NCD) Memorandum for Percutaneous Left Atrial Appendage Closure (LAAC) Therapy (CAG-00445N)

Dear Ms. Syrek-Jensen:

The American College of Cardiology (ACC), Heart Rhythm Society (HRS), and Society for Cardiovascular

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Saltzman, HeathDate: 12/09/2015
Comment:
I am an EP doc at a large academic medical center. I have many patient I follow for atrial fibrillation. Many of them have absolute or relative contraindications for oral anticoagulation.
The Watchman device will enable us to reduce their stroke risk, without an increased bleeding risk. This is especially true for older patients who have higher rates of bleedingO'Steen, MatthewTitle: MD
Organization: Coastal Cardiology, PA/Roper Hospital
Date: 12/09/2015
Comment:

Dear Mrs. Syrek-Jensen, JD,

I am a practicing interventional cardiologist in Charleston, SC. I have been involved in left atrial appendage closure by the Lariat device, Amplatzer Cardiac Plug and the Watchman device. I am writing to support the NCD for the Watchman device.

Protect AF and Prevail along with CAP-1 and CAP-2 have demonstrated the efficacy of the Watchman for preventing stroke and systemic embolism with a reduction in intracranial hemorrhage in patients

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Ellis, Christopher R.Title: MD, FACC, FHRS, Associate Professor
Organization: Vanderbilt University Medical Center
Date: 12/09/2015
Comment:

LAA closure has become an essential option for many patients in my practice at Vanderbilt. I have performed 31 Lariat LAA ligations, 15 Watchman LAA occluder implants, and referred 67 TT Atriclip device implants for patients with high stroke risks and high bleeding risks. I do not have an appreciation for what a patient who is "contra-indicated" to anti-coagulation looks like. Many of these patients had major bleeding while on OAC/NOAC, but were not actively bleeding to death and the time I

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Joyner, C.Title: MD
Date: 12/09/2015
Comment:

I do not agree with the CMS proposal regarding coverage of LAAC. I believe the evidence informing the use of LAAC is sufficient, and that LAAC does indeed treat an illness: left atrial stasis coagulopathy in atrial fibrillation, essentially the major cause of stroke in this chronic disease.

That the FDA and CMS reached disparate conclusions regarding the role for LAAC comes as little surprise to me. Warfarin has proven effective in preventing stroke, just not convenient,

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Mittal, SuneetTitle: Director, Electrophysiology
Organization: The Valley Hospital
Date: 12/09/2015
Comment:

Currently, I am Director of the Electrophysiology Laboratory for a community hospital in Northern New Jersey. I spend 100% of my clinical time in the office or electrophysiology laboratory. We have recently started our Watchman program; the program is a joint collaboration between our Electro-physiology and Structural Heart services.

I read with great interest the CMS’s proposed coverage decision for percutaneous left atria appendage (LAA) closure therapy (CAG-00445N). Based on my

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Chandhok, SheetalTitle: Dr.
Organization: BMMSA
Date: 12/09/2015
Comment:

CAG-00445N. As an implanter of this new and exciting technology in the field of atrial fibrillation, I wish to comment regarding the proposed NCD. There are countless number of patients who have atrial fibrillation in this country who are not anticoagulated, and suffer debilitating and devastating preventable strokes. I have seen first hand the removal of anticoagulation for falls, being elderly, GI bleeding, trauma, urinary hemorrhage, and fear resulting in preventable strokes which have

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Manuchehry, AminTitle: MD
Date: 12/09/2015
Comment:

To whom it may concern:

I am a physician practicing general cardiology and interventional cardiology with Heart Associates of Northern California, a private practice group in San Jose, California. My main hospital affiliation is with Good Samaritan Hospital in San Jose, CA. I have been in practice for more than 2 years and completed my interventional and structural heart training at Cedars-Sinai Medical Center in Los Angeles, CA. I have significant experience with the Watchman

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Beckmann, JamesTitle: MD, Director of Cath Labs
Organization: CardioVascular Institute, BannerHealth, Colorado
Date: 12/09/2015
Comment:

LAAC with the WATCHMAN device

  • Is stroke reduced with left atrial closure?
    - No good surgical studies on LAA ligation or removal at time of surgery
    - LAAC (WATCHMAN) proved to non-inferior to that of warfarin therapy. Entry criteria for this trial was ONE of the following: previous stroke or transient ischemic attack, congestive heart failure, diabetes, hypertension, or were 75 years or older
    The Lancet 2009:374:9689:534–42
    - No good surgical studies on LAA

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  • Arshi, ArashTitle: Interventional Cardiologist
    Organization: OhioHealth Heart and Vascular Physicians
    Date: 12/09/2015
    Comment:

    I am primarily concerned by the criteria for Condition 2 of the LAA closure NCD. While including patients with high CHADS2/CHA2DS2-VASc scores and high HAS-BLED scores is appropriate, I am concerned about the requirement for the patient to have a contraindication to warfarin. The PROTECT-AF and PREVAIL randomized controlled trials specifically required that patients be eligible for warfarin therapy. The only clinical trials data to help guide the use of the WATCHMAN device in patients with

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    Simons, GrantTitle: Co-Chief, Cardiac Electrophysiology
    Organization: Hackensack University Medical Center
    Date: 12/09/2015
    Comment:

    We commend the Centers for Medicare and Medicaid Services (CMS) for their detailed consideration of coverage for percutaneous left atrial appendage closure (LAAC) therapy using an implanted device (CAG-00445N). However, we strongly disagree with the primary conclusion of that analysis, i.e. that such therapy “is not reasonable and necessary to diagnose or treat an illness or injury or to improve the functioning of a malformed body member and, therefore, is not covered under §

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    Price, MatthewTitle: Director, Cardiac Catheterization Laboratory
    Organization: Scripps Clinic
    Date: 12/09/2015
    Comment:

    Thank you for the opportunity to comment on the proposed coverage decision for left atrial appendage (LAA) closure. I am an Interventional Cardiologist specializing in structural heart disease and I currently serve as Director of the Cardiac Catheterization Laboratory at Scripps Green Hospital in La Jolla, California. My experience with percutaneous LAA closure includes participation in the PREVAIL and CAP2 studies, and the evaluation of patients for LAA closure in the current commercial

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    Oldenquist, MBA, MS, JohnTitle: Director, Heart Institute
    Organization: Cedars Sinai Medical Center
    Date: 12/09/2015
    Comment:

    RE: Comments on the Proposed Decision Memo for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG-00445N)

    Dear Ms Syrek-Jensen

    I want to respond to the Proposed Decision Memo for national coverage for Percutaneous Left Atrial Appendage Closure (LAAC) Therapy using the Watchman device. I serve as Service Line Director for the Heart Institute at Cedars Sinai Medical Center, Los Angeles, CA. Cedars Sinai Medical Center has been the lead enrolling center for

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    Baker, BrettTitle: MD
    Date: 12/09/2015
    Comment:

    Comments on CMS Guidance Related to Watchman Device for Left Atrial Appendage Closure

    From: Brett Baker MD FACC
    Clinical Cardiac Electrophysiologist and Cardiologist
    Private Practice in Charleston, South Carolina since 1999
    Multi-year experience with anticoagulation for the prevention of stroke and systemic embolism with oral anticoagulants including warfarin, dabigatran, rivaroxaban, and apixaban
    Investigator: Amplatzer Cardiac Plug for occlusion of the left

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    Koullick, MariaTitle: Senior Director of Global Health Economics
    Organization: St. Jude Medical, Inc
    Date: 12/09/2015
    Comment:

    December 10, 2015

    Ms. Tamara Syrek Jensen, JD
    Director, Coverage and Analysis Group
    Centers for Medicare & Medicaid Services (CMS)
    7500 Security Blvd., Mail Stop S3-02-01
    Baltimore, MD 21244-1850

    Re: Proposed Decision Memorandum for Percutaneous Left Atrial Appendage Closure (LAAC) Therapy (Administrative File: CAG #00445N)

    Dear Ms. Syrek Jensen:

    St. Jude Medical, Inc. (SJM) is driven by our vision and mission to transform the treatment

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    Sanchez, CarlosTitle: Interventional Cardiologist
    Organization: OhioHealth-Riverside Methodist Hospital
    Date: 12/09/2015
    Comment:

    I’m an interventional cardiologist affiliated with Ohiohealth-Riverside Methodist Hospital in Columbus Ohio. We are a tertiary care institution who sees and treat complex patients with a multitude of comorbid conditions. We participated in the landmark trials upon which the FDA used the supporting evidence for the Watchman device approval. We treat patients on a daily basis at high risk for bleeding and whom we have seen had many complications from anticoagulation therapy used in the

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    Branham, ChandraTitle: VP, Payment & Health Care Delivery Policy
    Organization: AdvaMed
    Date: 12/09/2015
    Comment:

    December 9, 2015 (also submitted as PDF)

    Tamara Syrek Jensen, JD
    Director, Coverage & Analysis Group
    Office of Clinical Standards and Quality
    Centers for Medicare & Medicaid Services
    Mailstop C1-09-06
    7500 Security Blvd
    Baltimore MD 21244

    RE: Proposed Medicare Coverage Decision Memorandum for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG-00445N)

    Dear Ms. Syrek Jensen:

    The Advanced Medical Technology

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    Pompili, VincentTitle: Director Interventional Cardiovascular Medicine
    Organization: The Ohio State University
    Date: 12/09/2015
    Comment:

    My name is Vincent Pompili. I am a Professor of Medicine and the Director of Interventional Cardiovascular Medicine at The Ohio State University Wexner Medical Center and the Director of the Cardiac Catheterization Laboratories at The Richard M. Ross Heart Hospital. I fully support a National Decision by CMS to cover the procedure for percutaneous placement of a left atrial appendage occlusion device. He recently FDA approved WATCHMAN device may be the only option for appropriately selected

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    Haugh, ConnorTitle: Director of Cardiac Electrophysiology
    Organization: New England Heart Institute at Catholic Medical Center
    Date: 12/09/2015
    Comment:

    Dear Ms. Syrek Jensen, J.D.,

    As clinical electrophysiologists in a large cardiology practice in New Hampshire, we care for numerous patients with atrial fibrillation in our region. We strongly support CMS coverage for LAA occlusion which we believe will be an important tool in our management of stroke risk in patients with non-valvular atrial fibrillation.

    Despite the weight of evidence and a class I recommendation set forth by the 2014 AHA/ACC/HRS Task Force for the

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    Kim, JamieTitle: Staff Electrophysiologist
    Organization: New England Heart Institute at Catholic Medical Center
    Date: 12/09/2015
    Comment:

    Dear Ms. Syrek Jensen, J.D.,

    As clinical electrophysiologists in a large cardiology practice in New Hampshire, we care for numerous patients with atrial fibrillation in our region. We strongly support CMS coverage for LAA occlusion which we believe will be an important tool in our management of stroke risk in patients with non-valvular atrial fibrillation.

    Despite the weight of evidence and a class I recommendation set forth by the 2014 AHA/ACC/HRS Task Force for

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    Osman, AhmedTitle: Director EP lab, Broward Health Medical Center
    Organization: Florida Heart Rhythm Specialists , PLLC
    Date: 12/09/2015
    Comment:

    Dear Sir/ Madam

    I read with concern your proposals for coverage determination/ decision for Left Atrial appendage closure using the Watchman device, an FDA approved device , for use in high risk patients with non valvular atrial fibrillation, who are seeking an alternative to long term oral anticoagulation.

    As a clinical cardiac electrophysiologist in practice for 15 years , i have witnessed multiple misfortunes and unfavorable outcomes related to the use of oral

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    Schuger, ClaudioTitle: Director Clinical Cardiac Electrophysiology
    Organization: Henry Ford Hospital
    Date: 12/09/2015
    Comment:

    I comment in my capacity of the Director Of Cardiac Clinical Electrophysiology at Heart and Vascular Institute at Henry Ford Hospital in Detroit, Michigan. As can be expected, I deal with patients with AF on a daily basis, including the managing of these patients anticoagulation when indicated. In that capacity and throughout twenty five years of practice, I have a fair experience in identifying risks and conditions of patients that have experienced absolute and relative contraindications

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    Sheppard, RobertTitle: MD
    Organization: The Heart Institute
    Date: 12/09/2015
    Comment:

    I am very concerned about the proposed CMS NCD for Percutaneous LAA Closure. The decision specifically states that such terapy can only be provided to patients with NVAF who have a "contraindication to warfarin". However, the current protocol to safely implant the Watchman LAAC device REQUIRES at least 45 day (if not longer) treatment with warfarin untin endothelialization is complete around the device. This was the protocol used in the muticenter trials (PROTECT-AF, CAP, and PREVAIL) that

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    Munger, ThomasTitle: Left Atrial Appendage Closure (LAAC) Watchman
    Organization: Mayo Clinic
    Date: 12/09/2015
    Comment:

    Dear Ms. Syrek-Jensen:

    My comments relate to the issue of non-coverage for Watchman® device LAAC for stroke prevention in patients with non-valvular atrial fibrillation (AF). This is a very significant clinical problem and is getting more pronounced due to the rapidly aging American population.

    Multitudes of patients have non-valvular AF with increased risk of ischemic stroke based on CHADS-Vasc risk stratification, but are not candidates for conventional oral

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    Jenkins, James S.Title: Interventional Cardiologist
    Organization: Ochsner Clinic Foundation
    Date: 12/09/2015
    Comment:

    I am an Interventional Cardiologist at Ochsner Foundation Hospital in New Orleans, LA for past 21 years. I have 7 years experience with the Watchman device and have spent my entire career treating atrial fibrillation patients at risk for stroke and heart disease. For years the only therapy available was warfarin, but in the past decade, several alternative medications and devices have attempted to remedy the downfalls and inadequacies of warfarin therapy. Outpatient monitoring,

    More

    mehdirad, aliTitle: MD,Director OF EP service
    Organization: St Louis university hospital
    Date: 12/09/2015
    Comment:

    I really believe that watchman device needs to be promoted and supported in all aspects as it is the only non surgical currently available left atrial appendage occluder which can be used in patients with a fib and high risk of stroke and inability to receive anticoagulation due to one reason or another.

    CMS should also support this potentially life saving product and procedure.Freher, MarkTitle: Electrophysiologist
    Organization: JFK / Florida Electrophysiology
    Date: 12/09/2015
    Comment:

    To: Ms. Tamara Syrek-Jensen, J.D., Director of Coverage & Analysis Group

    Dear Ms. Syrek-Jensen:

    I have been involved with the WATCHMAN LAAC Therapy since the PREVAIL trial. Many patients have benefited from the device. Most have had relative contraindications to coumadin.
    The HASBLED score isn't a full measure of who could benefit as it doesn't include relative contraindications such as compliance, other medical issues such as syncope, occupation, lifestyle,

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    Raybuck, MD FACC FSCAI, BryanTitle: Director cardiac Cath Lab
    Organization: INOVA Heart and Vascular Institute
    Date: 12/09/2015
    Comment:
    Watchman should be covered for patients with HAS-BLED and CHA2DS2-VASc of 3 or higherCater, GraceTitle: MD
    Organization: MetroHealth Medical Center
    Date: 12/09/2015
    Comment:

    I am writing in support of national coverage for the Watchman left atrrial appendage occlusive device. I am a clinical cardiologist who takes care of patients with nonvalvulat atrial fibrillation. These patients require lifelong anticoagulation for stroke prevention, thus putting them at an increased risk of bleeding complications.On the other hand there are individuals who either are not able to adhere to the anticoagulation regimen, or cannot achieve adequate anticoagulation levels despite

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    Schuler, BrianTitle: MD
    Organization: Wellspan Cardiology
    Date: 12/09/2015
    Comment:

    Ms. Tamara Syrek-Jensen
    Director, Coverage & Analysis Group
    Centers for Medicare & Medicaid Services
    7500 Security Boulevard
    Baltimore, MD 21244

    RE: National Coverage Analysis (NCA) for Percutaneous Left Atrial Appendage Closure (LAAC) Therapy (CAG-00445N)

    Dear Ms. Syrek-Jensen:

    The CMS national coverage decision on the Watchman device, if left unchanged, will restrict a valuable treatment option to my practice and our atrial fibrillation

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    Haridas, AnandDate: 12/09/2015
    Comment:

    The Watchman LAA closure device is a novel therapeutic option for patients that cannot be safely anticoagulated. As a clinician I see a lot of Medicare patients who unfortunately suffered strokes while being off anticoagulation. Its not an easy decision to take one off Warfarin and now there is another safe and effective option to prevent strokes with the Watchman device.

    I urge the governance committee to look upon this device favorably. There is no lack of data supporting the use

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    Tschopp, DavidTitle: Electrophysiologist MD
    Organization: Texas Cardiac Arrhythmia
    Date: 12/09/2015
    Comment:

    Dear Ms. Tamara Syrek-Jensen,J.D.

    I am an Electrophysiologist with Texas Cardiac Arrhythmia. I would like to express my concerns regarding the CMS's Proposed Coverage Decision for Percutaneous Left Atrial Appendage Closure using the Watchman device.

    I think the descriptions regarding recommendations for the "eligible patient population" and indications need significant clarification.

    I am unclear regarding the statements relating to indications which

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    Patel, AshishTitle: MD
    Organization: Monmouth Cardiology Associates
    Date: 12/09/2015
    Comment:

    There are several issues with the coverage decision that I believe would adversely affect patients who would benefit from LAAC (left atrial appendage closure).

    I have specific concerns about coverage condition #2 using the phrase "contraindications to warfarin." There are many clinical scenarios where the patient may not have a contraindication to warfarin but has an intolerance to anticoagulation. The use of the word contraindication implies a significant criteria that would

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    Pickett, RobertTitle: MD
    Organization: St. Thomas Heart
    Date: 12/09/2015
    Comment:

    To whom it may concern: as an implanter and participant in the Prevail and Protect trials with Watchman, I have been involved with this device for years. I have two concerns regarding the release of the CMS decision- first I think the contraindication to warfarin/coumadin needs to be relative rather than absolute. Clinical scenarios often are grey rather than black and white. By following CHADS vas scores, outlining risks and assessing the patient, it can become very clear when a patient has a

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    Ahmed, MudassarOrganization: HealthEast Heart Care, St Paul, MN
    Date: 12/09/2015
    Comment:

    There is perhaps no medical device that has undergone as much scrutiny and been subject to as much rigorous trial data as the Watchman device.
    Multiple trials involving thousands of patients studied over several years have proven the superiority of Watchman over anticoagulation. Subjecting a patient to decades of anticoagulation exposes him or her to much more risk and from the societal standpoint is much more expensive than a single device implant.
    We strongly support a national

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    Mascarenhas, MarkTitle: Cardiac Electrophysiology
    Organization: Jersey Shore University Medical Center
    Date: 12/09/2015
    Comment:

    The utilization of the left atrial appendage occlusion device represents an important aspect in the treatment of patients with atrial fibrillation. As the population ages, there will be a large number of patients who require measures to prevent a thromboembolic event due to atrial fibrillation. A large number will be unable to tolerate oral anticoagulation. Please allow the LAAC device WATCHMAN to receive approval for those patients that are unable to tolerate oral anticoagulation. This

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    Sharma, SaumyaTitle: MD
    Organization: University of Texas Houston
    Date: 12/09/2015
    Comment:

    In our practice, we are selecting patients with CHADsVasc score of >=2. Patient must be able to tolerate short term anticoagulation but have a reasonable indication for being a poor long term anticoagulation patient. Patients with High HASBLED scores (>=3) or a history of bleeding complication on anticoagulation, or a fall risk.

    Patients (with CHADSvasc >2) who do not do well on warfarin (labile INR), poor compliance, or low time therapeutic range are reasonable candidates, since

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    Chiu, JohnTitle: MD
    Organization: Stanford Health Care
    Date: 12/08/2015
    Comment:

    LAA closure with the WATCHMAN device is a major advance in the prevention of stroke in patients with atrial fibrillation. It has now been proven to reduce the risk of serious stroke, intracranial hemorrhage, and major bleeding in atrial fibrillation patients at risk for stroke. Even more importantly, a mortality benefit has been demonstrated in patients receiving the WATCHMAN device.

    Coverage for WATCHMAN therapy is crucial for patients with an elevated risk for stroke, high

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    Lessmeier, TimothyTitle: Clinical Electrophysiologist
    Organization: Heart Clinics Northwest
    Date: 12/08/2015
    Comment:

    Dear CMS

    As a clinical electrophysiologist and newly trained Watchman implanter, I feel compelled to comment on your proposed LAAC Coverage proposal.

    While I believe you have carefully reviewed the current literature on Watchman, I am concerned by the potential limits being placed on this therapy for potential "high" risk populations that may not meet your criteria.
    Specifically, I am concerned by the requirement for a high CHADS2VASC score AND high HASSLED score AND

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    Hanzel, GeorgeTitle: MD
    Organization: Beaumont Hospital
    Date: 12/08/2015
    Comment:

    I am an interventional cardiologist who specializes in structural heart disease. I have been an investigator with the Watchman device since 2005 and have participated in the pilot study, PROTECT-AF, CAP-1, PREVAIL, and CAP-2.

    Overall I think that the CMS proposed NCD is excellent. However, I do have several comments that relate to conditions 2 and 6. First, I am unclear what CMS means by "contraindication to warfarin" since the clinical trials (and FDA approval) requred that

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    Doshi, AmitTitle: EP Divison Director
    Organization: Mercy Clinic
    Date: 12/08/2015
    Comment:

    As a practicing electrophysiologist for a large practice, for years have had droves of patients who suffer from atrial fibrillation and either have had a stroke or at high risk for a stroke based on their CHADs2-vasc score.

    Most of these patients are able to tolerate oral anticogulation. However there are numerous patients who have had significant bleeding on oral anticoagulation ranging from frequent skin bleeding, epistaxis to life threatening GI bleeding requiring surgery

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    Patel, ApoorTitle: Director of Complex Ablations
    Organization: Northwell Health
    Date: 12/08/2015
    Comment:

    I think the proposed coverage determination which restricts coverage to patients with a contraindication to warfarin is too narrow. The WATCHMAN device has shown long term superiority over coumadin, is cost effective based on recent data, and provides a mortality benefit as seen in the PROTECT AF trial. The coverage determination should be in line with the FDA approval which while broad in scope, allows decision to be made at the discretion of the physician and patient who has an appropriate

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    kassas, safwanTitle: interventional cardiologist
    Organization: Michigan Cardiovascular Institute
    Date: 12/08/2015
    Comment:

    Agree with current CMS proposed coverage decision but will kindly request consideration of the following.

    1- Benefit of Watchman device extends to population of patients who have contraindication to OAC and to those who are high risk but not contraindicated to OAC.the term "contraindication to warfarin" is not well defined in the literature as there are absolute contraindications, strong contraindications and week contraindications. but even the week contraindications can bring

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    Leahy, RobinTitle: Director, Electrophysiology Services
    Organization: Sanger Heart & Vascular Institute/Carolinas Healthcare System
    Date: 12/08/2015
    Comment:

    Thank you for affording me the opportunity to provide comments regarding the recent proposed NCD by CMS for the Watchman procedure.

    In my current role I serve as the administrative director for the Electrophysiology Service Line with the Sanger Heart & Vascular Institute/Carolinas HealthCare System. I have programmatic and operational responsibilities for heart rhythm care across the SHVI footprint. My background as a registered nurse, certified cardiac device specialist and

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    Yesenosky, GeorgeTitle: Director of Electrophysiology Jeanes Hospital
    Organization: Temple University Physicians
    Date: 12/08/2015
    Comment:

    We are excited to have for the first time an FDA approved nonpharmacologic therapy for the reduction of the risk of cardioembolic events and stroke in patients with atrial fibrillation. This is a unique and valuable tool which can be implemented in patients who are at risk for bleeding. Strong clinical data suggests that the implantation of the percutaneous left atrial appendage occlusion device is far superior to no therapy at all and is currently the only option available for patients who

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    Malhotra, RohitTitle: Assistant Professor
    Organization: University of Virginia
    Date: 12/08/2015
    Comment:

    I am an electrophysiologist at the University of Virginia, where I have been implanting Watchman devices starting with the PREVAIL CAP program. I treat patients with atrial fibrillation.

    I have some concerns regarding the CMS National Coverage Decision. Specifically, the language stating "contraindication to warfarin" is troubling. While often patients can not tolerate warfarin in the long term due to bleeding, with careful vigilance, these patients can often tolerate short

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    Taigen, TylerTitle: MD
    Organization: Summa Health System
    Date: 12/08/2015
    Comment:

    This letter is intended to respond to the CMS proposed national coverage decision for Percutaneous Left Atrial Appendage Closure (LAAC) Therapy. I am an electrophysiologist with Summa Health which is a large community hospital system in Akron Ohio. Our practice is hospital owned with a primary focus of delivering optimal healthcare for our patients with cardiac disease as well as development of research and education programs including our cardiology fellowship. Management of patients

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    Rihal, CharanjitTitle: M.D., MBA
    Organization: Mayo Clinic
    Date: 12/08/2015
    Comment:

    Dear Ms. Syrek-Jensen:

    I am Chair of the Division of Cardiovascular Diseases at Mayo Clinic Rochester, Minnesota, and a practicing structural interventional cardiologist. I have no conflicts of interest related to WATCHMAN or Boston Scientific.

    As almost all comments on your website indicate, I would like to extend my strong support for a decision in favor of coverage for the WATCHMAN device. Atrial fibrillation is a massive public health problem and many patients

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    Altman, ErikTitle: Chief of Electrophysiology
    Organization: Southside Hospital NS-LIJ
    Date: 12/08/2015
    Comment:

    A significant challenge in electrophysiology is proplerly caring for patients with Afib who require anticoagulation due to an elevated CHADS-VASc score. Many pts are unable to tolerate long term A/C and therefore an alternative needs to be available to them. The WATCHMAN device is crucial to delivering optimal care to this population. The criteria necessary to fufill in order to qualify for this device need re-evalaution. Many pts have a high CHADS-VASc score but do not have an elevated

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    Cooper, JoshuaTitle: Professor of Medicine, Director of EP
    Organization: Temple University Health System
    Date: 12/08/2015
    Comment:

    Percutaneous Left Atrial Appendage Closure Therapy represents a unique and valuable treatment option for atrial fibrillation patients who are stuck between a risk of stroke and a risk of bleeding. For these patients, there are already ample data to suggest that implantation of this device is a better option than providing no treatment at all, which has been the only alternative to date. To impose approval conditions or restrictions for this group of patients who have already demonstrated

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    Bazaz, RaveenTitle: Ass Prof of Medicine- Cardiac Electrophysiology
    Organization: University of Pittsburgh Medical Center
    Date: 12/08/2015
    Comment:

    I am a Cardiac Electrophysiologist at the University of Pittsburgh Medical Center. I treat patients with AF and have experience with the literature both supporting LAA closure in terms of stroke prevention as well as in performing such procedures. LAA closure has shown promise in preventing AF related strokes when compared with anticoagulation. I do support a registry on LAA closure to have further data on outcomes and complications. Although I agree with operator and institutional

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    o'neill, williamTitle: Director of Structural Heart Center
    Organization: Henry Ford Hospital, Detroit, Mich
    Date: 12/08/2015
    Comment:

    I am an experienced Interventional Cardilogist and have been implanting the Watchman device since it was FDA approved in May of 2015. I am confused about how to qualify a patient based on the proposed NCD. The proposal covers patients who have contra-indication to oral anitcoagulants.

    The Watchman device was approved for coumadin eligible patients. The NCD seems at odds with the IFU, please clarify. I have two patient scenarios that I would like clarified. I saw a patient with

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    Chari, RaviTitle: Senior Vice President, Clinical Excellence
    Organization: HCA
    Date: 12/08/2015
    Comment:

    We commend the CMS decision to allow coverage for Left Atrial Appendage Occlusion (LAAO) with an implanted device under Coverage with Evidence Development for patients with non-valvular atrial fibrillation (NVAF). However, we would like to comment on two conditions of coverage in the proposed National Coverage Determination.

    Condition 2, bullet 3: The patient has a contraindication to warfarin.

    Currently the Watchman™ Left Atrial Appendage Closure Device is the only

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    Lager, RobertTitle: MD
    Organization: Medstar Cardiology Associates
    Date: 12/08/2015
    Comment:

    I would like to comment on the evolving role of left atrial appendage closure, especially as it pertains to Watchman currently. I am an interventional cardiologist who performs LAA closure at Washington Hospital Center. This procedure I believe definitely has a role in the care of the atrial fibrillation patient, who is at elevated risk of bleeding. As per the pivotal studies, the patients who should be treated this way should have a CHADS Vasc score of 2 or greater (ie patients who

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    Malik, RajeshTitle: MD FHRS
    Organization: MCLEOD regional medical center
    Date: 12/08/2015
    Comment:
    we need to have alternative therapy for patients unable to tolerate oral anticoagulation and also patients with compliance issues and lack of resources to take medical therapy watchman device offers a noninferior alternativeShah, SaumilTitle: Cardiac Electrophysiologist
    Organization: Virginia Cardiovascular Specialists
    Date: 12/08/2015
    Comment:

    To the Director of Coverage and Analysis Group,

    I am a practicing cardiac electrophysiolgist whose primary patient population suffers from atrial fibrillation. It is the most common cardiac arrhythmia and afflicts patients in many ways. The most worrisome, however is the potential for stroke. Risk of stroke is estimated to be 5X greater with atrial fibrillation. After many stagnant years of medical research (warfarin, as the sole option), patients now have access to new oral

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    Hranitzky, PatrickTitle: MD, FACC, FHRS
    Organization: Texas Cardiac Arrhythmia
    Date: 12/07/2015
    Comment:

    To whom it may concern:

    I am writing in response to the CMS position on percutaneous left atrial appendage closure therapy. I am a cardiac electrophysiologist who has been in practice for over 10 years at both a major academic medical center (Duke University ~10 years) and more recently one of the busiest cardiac electrophysiology practices in the world (Texas Cardiac Arrhythmia). My practice is dedicated to the treatment of complex arrhythmias particularly with catheter ablation

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    Krishnan, KousikDate: 12/07/2015
    Comment:

    CMS coverage should be consistent with the clinical trial inclusion and exclusion criteria from the Protect AF and Prevail Trials. Specifically, these trials did not include patients that were contraindicated for anticoagulation.

    This technology provides an important technology for patients and should be strongly considered for coverage based on the clinical trial indications and the guidelines that have been published by HRS/ACC/SCAI.Matthews, RayTitle: Chief of Cardiology
    Organization: University of Southern California
    Date: 12/07/2015
    Comment:
    This device has been extensively studied and then restudied at the request of the FDA. Reimbursem*nt from CMS should be approved for the patients groups for which the device was studied. To do anything else is unscientific and statistically flawed.Kang, StevenTitle: MD
    Organization: Stanford Healthcare
    Date: 12/07/2015
    Comment:

    Despite publication of multiple favorable studies in peer reviewed journals and subsequent FDA approval, the CMS decision memo stating that the Watchman procedure is not reasonable and necessary is disappointing. This technology and the subsequent clinical benefit shown in the trials can have a profound impact in patient care both in preventing atrial fibrillation related stroke and sparing patients a lifelong sentence of anticoagulation. Although enrollment in a registry to track outcome

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    Sandhu, GDate: 12/07/2015
    Comment:

    There is an ever increasing population of aging Americans with atrial fibrillation who have gait or balance disorders that put them at risk of life threatening bleeds from minor injuries simply because they are on anticoagulants. Additionally, there are many patients with a history of repeated GI or GU bleeding who cannot be placed on anticoagulation.

    Strokes are devastating emotionally and physically for entire families and are extraordinarily expensive on our healthcare system.

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    Varghese, VincentTitle: Director, Interventional Cardiology Fellowship Pro
    Organization: Deborah Heart and Lung Center
    Date: 12/07/2015
    Comment:

    In reference to the proposed coverage decision for the Watchman device, I would like to make a few comments regarding my clinical experience and practice.

    I am an Interventional Cardiologist at Deborah Heart and Lung Center in New Jersey, and am part of the heart team at our institution. We have used the Watchman device in appropriately indicated patients for the prevention of left atrial appendage thrombus with good procedural success and clinical safety.

    Although I agree

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    Vidovich, MladenTitle: Associate Professor of Medicine
    Organization: University of Illinois at Chicago
    Date: 12/07/2015
    Comment:
    I am writing to support the Watchman device as it offers an invaluable tool to treat patients with atrial fibrillation.
    Oral anticoagulation is frequently associated with significant side-effects and many patients are left with no options.
    For the first time, the Watchman LAA Atrial Appendage Occlusion treatment provides an alternative treatment for this high-risk group of patients.Sanchez, JoseTitle: Dr.
    Organization: The Heart Health Center
    Date: 12/07/2015
    Comment:

    I am writing on behalf of physicians and patients. As an electrophysiologist, there is a significant need alternatives to anticoagulation in order to treat patients with non-valvular AF at high risk for stroke. While novel anticoagulants have helped offer an option in patients with difficulty dosing warfarin or tolerating long-term anticoagulation, discontinuation rates for these drugs remain significantly high. Prior to the availability of this technology, patients who have to choose

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    Ellsworth, BetsyTitle: Director, EP Clinical Research
    Organization: Icahn School of Medicine at Mount Sinai
    Date: 12/07/2015
    Comment:
    Implanting centers need additional information regarding the requirement for data collection on patients on long-term OACs as a control arm. The rationale for this requirement is well appreciated, however the operational and regulatory implications are unclear.Shepard, RichardTitle: MD
    Organization: Virginia Commonwealth University
    Date: 12/07/2015
    Comment:

    I am a cardiac electrophysiologist at VCU in Richmond VA. I have been treating atrial fibrillation for 20 years and have been involved in the Lariat procedure and more recently implanting the Watchman device. Many patient have difficulty taking oral anticoagulants. I have seen several major bleeds and hemorrhagic strokes. In patient who are difficult to anticoagulate I have seen strokes from subtherapeutic INR. Patient with renal failure may not be able to take NOACs.

    Our center

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    Dahu, MusaTitle: MD, Cardiac Electrophysiologist
    Organization: Spectrum Health
    Date: 12/07/2015
    Comment:

    To whom it may concern

    We were excited that the LAA occlusion device was finally FDA approved a few months ago. There are many patients who are in desperate need for alternative to stroke prevention. In fact, we had a long list of patients who were not on blood thinners for various clinical reasons awaiting this approval.

    At Spectrum health, we have implanted 16 devices thus far successfully. When assessing your proposed criteria, I have two reservations.

    This

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    Jaber, WaelTitle: MD
    Organization: Cleveland Clinic
    Date: 12/07/2015
    Comment:

    We have read with interest the proposed CMS proposed decision memo on left atrial appendage closure. While we appreciate CMS’s concern regarding misuse of the technology and CMS’s role in safe guarding patients from potential harms of new technology I wish to comment on two issues.

    Condition 2: Lists that the three conditions: high risk of stroke and high risk of bleeding and contraindication to warfarin have to be met for LAA occlusion to be reasonable. However this scenario would

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    Shah, ManishTitle: Program Director CETP WHC
    Organization: Medstar Heart and Vascular Institute
    Date: 12/07/2015
    Comment:

    The contraindication to oral anticoagulation requirement is concerning for me as a practioner.
    Risk stratification using the HASBLED score (2 or higher) appears more reasonable:

    Clinical Scenario:
    82 year old female with long standing persistent atrial fibrillation. HTN, DM and prior history of stroke who is currently taking aspirin therapy (not oral anticoagulation due to frequent falls). She has a high CHADSVASC score, HASBLED score of 3. We are concerned about her

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    Wuhl, JeffreyTitle: Dr.
    Organization: Main Line Health
    Date: 12/07/2015
    Comment:
    This is a safe and effective method of stroke prevention for patients with Afib who cannot be anticoagulated long-term. This is a fairly significant population. It is crucial that CMS cover it so we can continue to offer it to these patients. I am personally involved with this procedure as the echocardiographer, so I feel that I speak from a place of experienceAlli, OluseunTitle: MD
    Organization: University of Alabama Birmingham
    Date: 12/07/2015
    Comment:

    I agree with the current proposed coverage decision by CMS for the Watchman LAAC therapy. I believe based on the evidence that we have that the device is non inferior to coumadin and may be superior and should be made available to patients with a high risk of stroke and a high bleeding risk.
    A gradual and sustained roll out of this technology to high risk patients is a reasonable approach and the use of registry to collect real world data is important.
    I have been involved with the

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    Borge, RickTitle: Practicing Electrophsiology
    Organization: Abington-Jefferson Health Network
    Date: 12/07/2015
    Comment:

    I am a cardiac electrophysiologist who has been in active practice for 15 years. My practice focus is atrial fibrillation and, as a result, I care for thousands of patients with this condition. To date, I have implanted 3 Watchman devices and have been impressed with the device performance and its ability to completely occlude the LAA.

    Regarding the proposed CMS guidelines for approval, I have the following concerns:

    1- The wording currently states that qualifying patients

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    Friedman, M.D., Paul A.Title: Cardiovascular Diseases
    Organization: Mayo Clinic
    Date: 12/07/2015
    Comment:

    Paul A. Friedman, M.D.
    Cardiovascular Diseases
    507-255-2446 Fax 507-255-2550
    friedman.paul@mayo.edu

    December 7, 2015

    Director, Coverage and Analysis Group
    Re: LAAC Therapy CED
    Centers for Medicare & Medicaid Services (CMS)
    7500 Security Blvd., Mail Stop S3-02-01
    Baltimore, MD 21244-1850

    Dear Director:

    Thank you for the opportunity to comment on the proposed decision for percutaneous left atrial appendage closure

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    Reeder, M.D., Guy S.Title: Cardiovascular Diseases
    Organization: MAYO CLINIC
    Date: 12/07/2015
    Comment:

    December 7, 2015

    Ms. Tamara Syrek Jensen, J.D.
    Director, Coverage and Analysis Group
    Re: LAAC Therapy CED
    Centers for Medicare and Medicaid Services (CMS)
    7500 Security Boulevard, Mailstop S3-02-0l
    Baltimore, MD 21244-1850

    Dear Ms. Syrek Jensen:

    I am an interventional cardiologist in active practice at Mayo Clinic, Rochester, Minnesota. I have been involved in structural cardiac intervention as well as interventional cardiology for 35

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    Hopkins MD FACC FSCAI, JamesTitle: Medical Director of the Cardiac Cath Lab
    Organization: Christiana Care Health Systems
    Date: 12/06/2015
    Comment:

    Regarding Proposed Decision Memo for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG-00445N)

    Recognizing that there is clinical judgement and patient choice that is incorporated into the decision to do a procedure on any inidividual patient, I think it is important to word the indication for the procedure as accurately as possible.

    First, # 2 states that there should be a high CHADS2 or CHA2DS2-VASc score. I think that a CHADS2 or CHADS2-VASc score that is

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    Bahu, MarwanTitle: MD
    Organization: Biltmore Cardiology
    Date: 12/06/2015
    Comment:
    I like to urge you to make the Watchman device available to our patients who are in need of this device. As time passes without action, many patients who can not be anticoagulated are not protected from stroke. It is very frustrating not being able to help our patients at risk.Han, RichardTitle: MD
    Date: 12/06/2015
    Comment:

    Thank you for the opportunity to comment on the proposed coverage decision for percutaneous left atrial appendage (LAA) closure therapy. I am a practicing interventional cardiologist with a special interest in structural heart disease. I received my MD degree from the University of Pennsylvania, my internal medicine training from the Brigham and Woman's Hospital, and my cardiology and interventional cardiology training from the Massachusetts General Hospital.

    While the majority

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    Karam, EdmundTitle: MD
    Organization: Jersey Shore University Medical Center
    Date: 12/06/2015
    Comment:
    It is important to avoid vague terminology/criteria with respect to coverage of this device. CMS should clearly state exactly what CHADSVASC and HASBLED scoring criteria will be covered. Creation of a registry is reasonable, and there could certainly be a condition that other scoring schemes will be considered in the future if so validated in future studies.Amorn, AllenDate: 12/06/2015
    Comment:

    This limitation of coverage is confusing and concerning to physicians and patients alike. Certainly it is understandable to want a more clearly defined reason for patients to seek LAAC options. However to use terms like "warfarin intolerant" is inconsistent at best. CMS is obviously aware that patients whom are truly warfarin intolerant would not be able to take the short term course of warfarin which was part of the protocol for nearly all watchman patients. The only published data for

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    nicholson, williamOrganization: wellspan health system - york hospital
    Date: 12/06/2015
    Comment:

    There are several very concerning issues regarding the CMS NCD coverage decision for LAA closure. As I am sure that the decision makers are aware, the contraindication to warfarin therapy requirement directly contradicts the trials and requirements of LAA devices. Warfarin is used for the first 4-6 weeks with each of the devices until the physician is able to ensure that the closure was adequate. It would make more sense to state that the patient should have a relative contraindication

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    Feldman, TedTitle: MD
    Date: 12/06/2015
    Comment:

    Several elements of the proposed coverage rule for left atrial appendage occlusion might be modified.

    The second condition stipulates a high HAS-BLED score. This score is not clinically validated and thus it is difficult to justify this requirement. Furthermore the other 2 conditions, a high CHADS2 score in conjunction AND a contraindication to warfarin encompass the entire target population intended in the decision. Some patients who have a bleeding episode without a high

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    Naik, HurshTitle: MD
    Organization: St. Joseph's hospital
    Date: 12/06/2015
    Comment:

    I am an interventional cardiologist in a practice that treats more 3000 thousand patients with atrial fibrillation. There stroke risk is known to be more than 5 times without anticoagulation. I educate every single patient on anticoagulation but still 1/4 patients will not be on it for a variety of reasons which include 1.) cost 2.) bleeding 3.) inconvenience. The cost of bleeding and disabling stroke to the health care system is difficult to measure but is likely similar to heart failure

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    Klugherz, BruceTitle: MD
    Organization: Abington Jefferson Health
    Date: 12/06/2015
    Comment:

    As an interventional cardiologist and Medical Director of the Cardiac Catheterization Laboratory at Abington Hospital (of Abington Jefferson Health), I applaud CMS for its proposal to cover LAAC using the WATCHMAN Device. We began implanting WATCHMAN in August, 2015, and our experience has been quite favorable so far. The patients have been carefully selected and the outcomes have all been positive. However, having reviewed the language of CMS's proposed coverage decision, I am concerned

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    Pinto, DuaneTitle: Associate Professor, Harvard Medical School
    Organization: Beth Israel Deaconess Medical Center, Boston, MA
    Date: 12/06/2015
    Comment:

    I am somewhat troubled when considering clinical application of the NCD for left atrial appendage closure (LAAC. First, is the requirement for high HAS-BLED Score. While this score has been validated and compares favorably with other stratification tools for bleeding, it has not been validated in all pertinent cohorts yet it is to be used for all cohorts when determining whether LAAC. There are many where the HAS-BLED score does not define the totality of short and long term bleeding

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    Singh, JagTitle: Associate Chief, Cardiology Division
    Organization: MGH
    Date: 12/05/2015
    Comment:

    Currently I am Associate Chief of Cardiology at a tertiary hospital center. I spend 40% of my time in the EP lab performing complex procedures. The Watchman device can be delivered easily and safely in the vast majority of patients with non-valvular AF. The safety of this device is supported by >10 years of experience at European Centers and numerous clinical studies.Regarding CMS's proposed coverage decision several comments are in order, specifically regarding Conditions 2 and

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    May, StephenTitle: MD
    Organization: Arrhythmia Associates of South Texas
    Date: 12/05/2015
    Comment:

    Hello.

    I am a cardiac electrophysiologist that treats hundreds of patient with atrial fibrillation every year. I have watched eagerly the development of percutaneous left atrial appendage closure therapy and was involved in publishing one of the initial series of patients treated with the Lariat suture exclusion of LAA system. After reviewing the totality of the literature on Watchman, I am convinced it is an excellent alternative to anticoagulation in patients with atrial

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    Ebersole, DouglasTitle: MD
    Organization: Watson Clinic LLP
    Date: 12/05/2015
    Comment:

    I greatly appreciate the work put into the CMS policy and agree with items such as training and a database for outcomes. However, I feel the requirement for a high HAS BLED score and "CONTRAINDICATION" to warfarin is far too strict and will eliminate a large number of patients who would benefit from the procedure. I would recommend wording of approval to be "High risk of bleeding by CHADS2 or CHA2DS2-Vasc score and felt to be at high risk for bleeding on long term anticoagulation". This

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    Huber, KennethTitle: MD.
    Organization: Saint Luke's Mid Americal Heart Institute, Kansas City, MO.
    Date: 12/05/2015
    Comment:

    Dear Ms. Tamara Syrek-Jensen,J.D.

    On behalf of the physicians and patients we serve at the Saint Luke's Mid America Heart Institute in Kansas City, I would like to take this opportunity to comment on CMS's Proposed Coverage Decision for Percutaneous Left Atrial Appendage Closure using the Watchman device. I have been personally involved with this device for now over 10 years, having implanted my first Watchman in 2005 as part of the Protect AF trial. I have implaned over 80

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    Samii, SorayaTitle: Physician
    Organization: Hershey Medical Center
    Date: 12/04/2015
    Comment:

    I am cardiac electrophysiologist at a tertiary care university hospital. I care for a wide range of patients with atrial fibrillation and our practice is a referral destination for difficult to manage patients with atrial fibrillation.
    Often these patients are those that have challenges to chronic anticoagulation despite a high risk of stroke based on prior stroke history or risk factors based on the CHADS VASC score. Their issues with anticoagulation often are not reflected in the

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    Mainigi, SumeetTitle: Associate Director of Electrophysiology
    Organization: Einstein Medical Center
    Date: 12/04/2015
    Comment:

    As a busy, board-certified electrophysiologist practicing in Philadelphia, PA who treats many atrial fibrillation patients, I anxiously await the CMS decision on LAA Closure Therapy. As you are well aware, atrial fibrillation is a major public health problem. It remains the largest cause of preventable stroke in the United States. While it is well-understood by physicians that anticoagulation can reduce this risk, we know many patients are not getting the therapy they need. I see this

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    Greenstein, EugeneTitle: Electrophysiologist
    Organization: Dupage Medical Group
    Date: 12/04/2015
    Comment:

    I'm an electrophysiologist with Dupage Medical Group in the West Suburbs of chicago and solely practice electrophysiology with 50% of my practice suffering from atrial fibrillation.

    I've reviewed CMS's 7 proposed criteria for WATCHMAN coverage and agree that this new technology needs to be rolled out in a very deliberate way, that encourages only appropriate patient selection criteria. I appreciate the efforts to include a registry and believe further study should be performed

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    kalbfleisch, stevenTitle: MD
    Date: 12/04/2015
    Comment:

    I agree with the approval of LAA closure therapy but have concerns regarding the conditions to be met for approval of patients to recieve the device. The need to have a "high" Chads-vasc and Has-bled score is to vague. If the patient qualifies for coumadin therapy then the use of the device may be a reasonable alternative if it is felt that the risk benefit ratio is in their favor. The Has-bled score is also not often utilized in a clinical situation and does not account for many of the

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    Holshouser, JohnTitle: MD
    Organization: Sanger Heart and Vascular Institute, Carolinas Medical Center
    Date: 12/04/2015
    Comment:

    Colleagues at CMS,

    As a practicing cardiologist and electrophysiologist, I am excited to have a national coverage decision for percutaneous left atrial appendage closure (LAAC) proposed. This is a revolutionary technology that provides an option for our increasing burden of atrial fibrillation patients, many of which who are contraindicated from long-term oral anticoagulation. I have reviewed the 55 page document and in particular focused on the 7 conditions for which LAAC therapy

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    Morris, KentTitle: MD
    Organization: Norton Healthcare
    Date: 12/03/2015
    Comment:

    Some clarification of condition number 2 would be beneficial. Specifically what would or would not be considered "high" risk scores. For example scores of 0 or 1 it would not make sense to use the device and probably should not be covered. And also how is contraindication to warfarin defined. Requiring an absolute contraindication to warfarin would actually go against the FDA labeling, but a relative contraindication, intolerance or contraindication to long term warfarin would still be

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    Maini, BrijeshwarTitle: MD
    Organization: TENET Florida
    Date: 12/03/2015
    Comment:

    I am an interventional cardiologist and have been doing LAA closure since the initiation of PROTECT AF Trial and am currently implanting them commercially. I feel they are a very important tool in our armamentarium to treat patients who need a non pharmacological alternative for stroke prophylaxis.
    The trials were run initially with a CHADS score of 1 or greater and then 2 or greater and have shown a mortality benefit. The decision to offer this alternative should be based on the results

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    Kanj, MohamedTitle: Associate Director, Electrophysiology Labs
    Organization: Cleveland Clinic Foundation
    Date: 12/03/2015
    Comment:
    I fully support the approval of this device. I beleive it offers a great opportuinity for many of my patients who anticoagulation would be a concern for them whether it is life style modification changes or at increased risk of anticoagulation. I completly agree that registry is needed to further monitor these patients and monitor the skills of the physicians and or institutions results.Ferrell, MargaretTitle: Physician
    Organization: Southcoast Health
    Date: 12/03/2015
    Comment:

    To the CMS Officer,

    I am writing this response to your proposed decision that “left atrial appendage closure is not reasonable and necessary to treat an illness or improve function and therefore not covered under the social security act.”

    I am a Board Certified Cardiologist and the Physician in Chief for Cardiovascular Services at Southcoast Health System in Fall River. We are the largest Health Care System in Southeastern Massachusetts, East Bay and Rhode Island. Per recent

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    Mathew, DilipTitle: MD
    Organization: Heart rhythm Consultants PA
    Date: 12/03/2015
    Comment:

    I appreciate the opportunity to comment on the proposed decision by CMS regrading coverage for the Left Atrial appendage Occlusion device (WATCHMAN). I am a cardiac electrophysiologist in Sarasota Florida and my practice is entirely devoted to management of cardiac arrhythmias and a large part of it involves treating patients with atrial fibrillation. As cardiologists and electrophysiologists we were gratified to finally see the FDA approval for the Watchman device come through earlier

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    Ho, PaulTitle: M.D.
    Organization: Fairbanks Memorial Hospital
    Date: 12/03/2015
    Comment:

    I am a practicing interventional cardiologist. I see many patients with non-valvular afib. I have a few comments about the proposed 7 conditions of the CED, specifically related to condition #2 and 6.

    Condition 2: In my real world clinical practice, I would find it difficult to completely view "warfarin contraindication" solely based on the HAS-BLED score. There are conceivable patients with a significant history of medical noncompliance, fall-risk or at- risk occupations for

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    whalen, sean patrickTitle: MD
    Organization: wfubmc
    Date: 12/03/2015
    Comment:

    We feel this therapy is a tremendous step forward in our capacity to provide comprehensive care for patients with atrial fibrillation. I feel it is well suited for patients who will require lifelong anticoagulation for non-valvular AF and who are not ideal candidates for warfarin. These reasons most often include real or perceived fall risk and bleeding. I believe this will help us close the gap between the guidelines for stroke prevention and the practice patterns in real life practice

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    Elmouchi, DarrylTitle: Chief, Division of Cardiovascular Medicine
    Organization: Spectrum Health
    Date: 12/03/2015
    Comment:

    I am a long-time practicing electrophysiologist whose primary focus is on atrial fibrillations. Over the years, I have cared for thousands of patients with AF. I have also cared for many patients who have suffered thromboembolic complications from this increasingly common problem. Strokes from AF tend to be devastating. I view my primary job is to assess a patients risk for stroke and do everything I can to minimize this risk. In the era prior to the novel oral anticoagulants, this was

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    Hanon, SamTitle: Director, Cardiac Electrophysiology
    Organization: Mount Sinai-Beth Israel
    Date: 12/03/2015
    Comment:

    Dear CMS:
    I am writing this response to your proposed decision that “left atrial appendage closure is not reasonable and necessary to treat an illness or improve function and therefore not covered under the social security act.”
    I am a board certified cardiac electrophysiologist and Fellow of the Heart Rhythm Society. My practice is exclusively electrophysiology and I treat a large number of patients with Afib.
    I have no financial ties to industry Boston Scientific or any other

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    Midwall, ScottTitle: MD, FACC, FSCAI
    Date: 12/03/2015
    Comment:

    I am an Interventional Cardiologist with advanced training in structural heart and vascular therapies and practice in a private practice setting in South FL. I have been fortunate to have been one of the first implanters in South FL since the technology became FDA-approved this past Spring. I believe it is a very necessary procedure that serves a very underserved population of patients. It offers therapy that has shown short-term non-inferiority and long-term superiority to conventional

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    Holmes, Jr., M.D., David R.Title: Division of Cardiovascular Diseases & Internal Med
    Organization: MAYO CLINIC
    Date: 12/03/2015
    Comment:

    December 3, 2015

    Ms. Tamara Syrek-Jensen, JD
    Director, Coverage and Analysis Group

    Dear Ms. Syrek-Jensen,

    This communication is in response to the request for comments to the proposed NCD on the Watchman™ device for left atrial appendage occlusion. The FDA language at the time of approval was excellent - "The Watchman device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with nonvalvular atrial

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    Lee, JayTitle: M.D.
    Organization: Orange County Heart Institute
    Date: 12/02/2015
    Comment:

    Dear CMS:

    I am writing this comment to convey my deepest disappointment with your coverage decision regarding Watchman, LAA occluder. Orange County Heart Institute participated in the Protect AF trial and CAP, and CAP 2 registries. We have had significant experience with the treatment and based on the feedback from our patients, it has been one of the most rewarding treatments that we offer our patients with atrial fibrillation.

    Managing the increasing number of

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    Schwartz, RobertTitle: Cardiologist, Director of Education
    Organization: Minneapolis Heart Institute and Foundation
    Date: 12/02/2015
    Comment:

    Subject: Public comment on percutaneous left atrial appendage closure using the Watchman percutaneous device.

    Please consider this memo in response to CMS Public comment request for the Watchman percutaneous left atrial appendage closure therapy.

    I am a practicing, board-certified Cardiologist at the Minneapolis Heart Institute in Minneapolis Minnesota and have been in Cardiology practice for more than 30 years.I care for all types of cardiovascular patients,

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    Kaddissi, GeorgesTitle: MD
    Organization: Cooper Health System-Cardiovascular Associates of the Delaware V
    Date: 12/02/2015
    Comment:

    Dear Sirs,

    I am currently an Interventional Cardiologist practicing in Southern New Jersey . My main practice is at Cooper University Hospital and Rowan Medical School- I'm a very involved in most interventional procedures especially the structural program including TAVR, mitral clip, and LAA closure using the Watchman device and the Lariat suture system.I have had the opportunity to become an early adopter of the WATCHMAN technology since FDA approval. Please allow me this

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    Kim, MichaelTitle: Assistant Professor of Medicine/Cardiology
    Organization: University of Colorado Denver
    Date: 12/02/2015
    Comment:

    Thank you for the opportunity to comment on the Proposed Decision Memo for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG-00445N).

    I am an interventional cardiologist practicing at a large, tertiary care academic medical center in Colorado. I have been in practice for over 6 years and have a focused area of expertise in structural and valvular heart disease and interventions. Specifically, I have extensive experience in various novel percutaneous structural heart

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    Sommer, RobertTitle: Director, Left Atrial Appendage Board
    Organization: Columbia University Medical Center
    Date: 12/02/2015
    Comment:

    To Whom It May Concern:

    My name is Dr. Robert Sommer and I am a practicing interventional cardiologist at New York Presbyterian-Hospital (Columbia University Medical Center). I am the leader of the multispecialty advisory group, which has been assembled here at the hospital, for the management of patients with atrial fibrillation. We are charged with optimizing both their medical management, to minimize the risks of stroke and bleeding, as well as their quality of life,

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    Bernal, JuanTitle: MD, MSc, F.A.C.C.
    Organization: Alabama Cardiovascular Group
    Date: 12/02/2015
    Comment:

    Thank you for the opportunity to comment on the NCD proposal for LAA Closure Therapy. I am an interventional cardiologist in Birmingham, AL with extensive experience in structural heart procedures. I am currently part of a "Heart Team" that has been performing the Watchman procedure since June 2015.
    While PROTECT AF and PREVAIL demonstrated the safety and effectiveness of the Watchman device in stroke prevention of NVAF patients, I appreciate the guidelines CMS has provided for the

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    Dhawan, RajivTitle: Interventional Cardiology
    Organization: Phoenixville Hospital
    Date: 12/02/2015
    Comment:

    I applaud CMS’s proposal to cover Watchman LAAC therapy. I am a very busy Interventional Cardiologists in Pennsylvania and I spend most of my time in the cath lab managing patients with various vascular issues that suffer from bleeding events of various manifestations. These patients are a significant financial burden to the hospital and the rest of the Medicare system. Major bleeding events can cost in excess of 23,000 dollars and Intra-cranial Hemorrhage can cost 50,000. Cost is one

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    Kashani, AmirTitle: MD
    Organization: Houston Methodist Hospital
    Date: 12/02/2015
    Comment:

    I am an interventional cardiologist involved in many clinical trials over the past decade (including some of the original Watchman clinical trials/registries). There are several issues with the requirement of a HASBLED score and a contraindication to Coumadin therapy. A HASBLED score requirement was not part of the original Watchman trials. As a result, we have no concrete randomized data on what score to choose and how would such a score impact the physician’s decision for a patient’s

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    Qureshi, WasifTitle: Medical Director Structural Heart Disease Program
    Organization: Christianacare Health Systems
    Date: 12/02/2015
    Comment:

    1) Currently I am the Medical Director of the Structural Heart Disease Program in the Section of Cardiology at Christiana Care Health Systems which is the largest health care system in Delaware.

    2) I spend nearly 100% of my time in the cardiac catheterization laboratory or hybrid operating room and perform high volume coronary, peripheral and structural heart interventions and seeing complex patients.

    3) I have placed multiple Watchman devices and have concluded that, in

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    Ensley, R. DouglasTitle: MD
    Organization: Warren Clinic Cardiology of Tulsa, Saint Francis Hospital
    Date: 12/02/2015
    Comment:

    1. It seems incomprehensible that all of the randomized data with this device upon which FDA approval was based was obtained in patients who by protocol were able to take anticoagulation with warfarin and yet the NCD proposes only to allow patients with a contraindication to coumadin. This is not the patient population that was studied and this criterion appears to represent a direct contradiction to the FDA approval document which states that it is approved for use in patients who are

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    Durrani, SarfrazOrganization: Medstar Heart Institute
    Date: 12/02/2015
    Comment:

    The majority of my practice involves taking care of patients with atrial fibrillation.

    Oral anticoagulation is the mainstay of stroke risk reduction in patients at high risk of stroke in the setting of AF
    Any patient with a CHA2DS-VASc score of 2 or more is at risk and needs OAC or other means of stroke risk reduction.
    A substantial number of patients are unable to take OAC or remain unprotected, either due to a contraindication to or due to a failure of OACs

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    Scherer, MarkusTitle: MD
    Date: 12/02/2015
    Comment:

    Condition 1: Agree

    Condition 2:
    -Simplify to state a CHADSVASC2 score of >= 2.
    -Contraindication to anticoagulation should be labeled as a relative contraindication to warfarin at the physician's discretion with benefits felt of the device felt to at least equal or outweigh its risks.

    Condition 3-5: Agree.

    Condition 6: Disagree with registry control arm of anticoagulant Rx. Patient's will not be randomized and comparison due to biases will not be

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    Azam, SalmanTitle: Cardiologist
    Date: 12/01/2015
    Comment:

    Dear CMS panel members,

    I am writing to appeal your proposed decision: left atrial appendage closure is not reasonable and necessary to treat an illness or improve function and therefore not covered under the social security act. I am quite surprised that despite FDA approval for the Watchman device based on extensive clinical trials data showing safety and efficacy of the device, the CMS has put forward the proposed decision which counters the FDA regulartory/approval process.

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    Sklar, MitchelTitle: MD FACC FSCAI
    Organization: Southcoast Physicians Group
    Date: 12/01/2015
    Comment:

    To the CMS Officer,

    I am writing this response to your proposed decision that “left atrial appendage closure is not reasonable and necessary to treat an illness or improve function and therefore not covered under the social security act.”

    I am a Board Certified Interventional Cardiologist and practice at Southcoast Health System in Fall River. We are the largest Health Care System in Southeastern Massachusetts, East Bay and Rhode Island. Per recent AHA/NCDR data we

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    Kazemian, PedramTitle: MD
    Date: 12/01/2015
    Comment:

    Hello,

    I am an electrophysiologist practicing at deborah Heart and Lung Center which is a tertiary cardiovascular center. I have a large population of patients with atrial fibrillation who would potentially benefit from WATCHMAN device. With regards to the recently released proposed coverage decision to cover percutaneous LAAC therapy by CMS, I had a few concerns that I would like to express here:

    1) The use of the phrase, "contraindicated to receive coumadin" when

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    Aji, JanahTitle: Director, Catherization laboratory,
    Organization: Cooper University Hospital
    Date: 12/01/2015
    Comment:

    I have been practcing academic Interventional cardiology for over 20 years, during which i was part of the development phase for several medical technologies, the last several years were particulary exciting with the advances in structural heart disease, namely the TAVR procedure and the watchman procedure.

    The Watchman procedure has stood significant scientific scrutiny , rigorous clinical trials and proved to be aplicable to daily clinical practice. while i agree that the procedure

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    Hook, BruceTitle: Director, Cardiac Arrhythmia Service
    Organization: Lahey Hospital and Medical Center
    Date: 12/01/2015
    Comment:

    I agree with most all the requirements set forth in the proposed policy. I have 2 concerns:
    1. The CHADS scoring system is no longer recommended for clinical use. I understand it was used in the clinical trials of the Watchman, but this was prior to CHADSVasc supplanting the CHADS scoring system. I think providers should use the CHADSVasc system and at their discretion, select appropriate candidates. My practice is to consider it's use only for CHADSVasc score >/= to 3.
    2. The

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    Saltzman, AdamDate: 12/01/2015
    Comment:

    To the CMS officer,

    I am writing this response to your proposed decision that “left atrial appendage closure is not reasonable and necessary to treat an illness or improve function and therefore not covered under the social security act.”

    I am a Board Certified Interventional cardiologist and practice at Southcoast Health System in Fall River. We are the largest Health Care System in Southeastern Massachusetts, East Bay and Rhode Island. Per recent AHA/NCDR data we

    More

    Malik, AmirTitle: Dir Intervetional Cardiology
    Organization: Plaza Medical Center
    Date: 11/30/2015
    Comment:

    I am interventional cardiologist who has been seeing patients with atrial fib for over 20years. There are a significant number of patients who either are unable or semi compliant to long term Coumadin therapy. Blood thinners are great options but at times not the best solution because of concerns regarding bleeding and compliance. This leaves a very large segment of my patient population with atrial fibrillation unprotected against stroke. There are roughly 40 to 60% of the patients

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    iyengar, srinivasTitle: MD
    Organization: Bradenton Cardiology Center/Manatee Memorial Hospital
    Date: 11/30/2015
    Comment:

    The current CMS proposal is not aligned with current FDA coverage in regards to Coumadin-eligible patients. I feel patients that are capable of taking coumadin but have high-risk features (i.e. history of bleeding, high-fall risks, difficult to control INRs/inability to afford NOACs) with elevated CHADS2-VASC scores should be eligible for the Watchman LAA device. Limiting this device to only "coumadin contraindicated" patients will severely limit the number of patients who may benefit from

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    Thambidorai, SenthilTitle: MD
    Organization: HCNT
    Date: 11/30/2015
    Comment:

    As an Electrophysiologist, Atrial fibrillation is the most common arrhythmia I see in practice. Per practice guidelines patients with a CHADS2VASC score >=2 have a stroke risk that necessitates long term anti coagulation therapy. This translates to around 90% of patients with AF. Of these warfarin-eligible patients many are still not receiving indicated therapy. This is due to a variety of factors as has been shown in studies and pointed out by other comments including difficulty managing

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    Rajendra, AnilTitle: MD
    Organization: Alabama Cardiovascular Group
    Date: 11/29/2015
    Comment:

    Thank you for this opportunity to discuss the draft National Coverage Determination for the Watchman left atrial appendage closure device. I would like to make a few comments about the device and highlight our group's experience.

    I am an electrophysiologist in a private practice group. I have extensive experience managing patients with non-valvular atrial fibrillation, including performing hundreds of afib ablations. We have been performing Watchman implants since June

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    Rose, GeoffreyTitle: MD
    Organization: Sanger Heart & Vascular Institute
    Date: 11/29/2015
    Comment:

    I appreciate the opportunity to comment on the CMS national coverage decision (NCD) for the Watchman device. I am an echocardiographer who has been in clinical practice for 19 years, and I help guide structural heart therapies including left atrial appendage occlusion with the Watchman device. I was a co-investigator in the PREVAIL study, which investigated the safety of the Watchman device. I continue to provide TEE guidance for implantation of the device as an FDA approved commercial

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    Woollett, IanOrganization: Cardiovascular Associates, Ltd.
    Date: 11/29/2015
    Comment:

    I appreciate the opportunity to comment on the CMS proposed decision regarding coverage for Left Atrial Appendage occlusion devices. Overall, the decision seems well thought out, and I especially agree with the need for a registry to track the safety and efficacy of these devices as they are used outside of clinical trials. I do however have concerns about some aspects of the coverage decision as outlined below:

    Condition #2 lists a number of patient inclusion criteria, starting

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    Kirtane, AjayTitle: Assoc Prof Medicine, Director of Cardiac Cath Labs
    Organization: Columbia University / New York-Presbyterian Hosital
    Date: 11/29/2015
    Comment:

    I am an academic Cardiologist at Columbia University/New York-Presbyterian Hospital in New York, and am writing regarding proposed National Coverage Decision for Percutaneous, Transcatheter Left Atrial Appendage Closure (LAAC) Therapy with the WATCHMAN device. I serve as the Director of the Cardiac Catheterization Laboratories at Columbia/New York-Presbyterian Hospital. Please note that I do receive institutional research support from Boston Scientific Corporation (the maker of this

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    Hermiller, JamesTitle: MD
    Organization: St Vincent Medical Group
    Date: 11/28/2015
    Comment:

    Utilizing the HAS-BLED score inadequately captures the population of patients benefiting from LAA closure therapy. For example the frail patient who frequently falls, but has yet not had a major bleed from such a fall, is an example. Furthermore, the triple anti-thrombotic therapy patient may be not be at high-risk by HAS-BLED but clinically considered to be at high risk of a hemorrhagic complication. Finally, HAS-BLED does not perform well in predicting intracranial

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    Whisenant, BrianTitle: MD
    Organization: Intermountain Healthcare
    Date: 11/27/2015
    Comment:

    Tolerance of oral anticoagulation exists along a spectrum. Most atrial fibrillation (AF) patients are well and most appropriately managed with chronic oral anticoagulation (OAC). However, there is a tremendous unmet need to prevent strokes and major bleeding complications among patients in whom the risk of chronic anticoagulation associated bleeding is either prohibitive or outweighs the benefits of this therapy. Alignment between the FDA indication and Medicare coverage for patients

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    Mark, GeorgeTitle: Cardiac Electrophysiologist
    Organization: The Heart House, Haddon Heights, NJ
    Date: 11/27/2015
    Comment:

    Dear Sirs,

    I am an Electrophysiologist practicing in the New Jersey suburbs of Philadelphia. Because of my affiliation with the Cooper University Hospital and Rowan Medical School, I have had the opportunity to become an early adopter of the WATCHMAN technology since FDA approval. To date we have implanted approximately 25 patients, without complication. Please allow me this opportunity to respond to the proposed CMS Coverage decision.

    Currently there are over 7000

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    Choi, JamesTitle: MD, FACC, FSCAI
    Date: 11/27/2015
    Comment:

    I am an interventional cardiologist at Baylor University Medical Center in Dallas TX.
    I agree with CMS coverage conditions point 1,3-7.

    I don't think point 2 with regard to contraindication to warfarin is consistent with prior watcham study data. In fact, by study design patients should be treated with warfarin for 45 days post device implantation until adequate seal is confirmed by repeat TEE. In fact if an adequate seal is not obtained—pts should remain on

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    Zhao, DavidTitle: Chief, Cardiovascular Medicine
    Organization: Wake Forest Baptist Heakth
    Date: 11/27/2015
    Comment:
    This device and LAA closure as whole provides significant benefit over oral anti-coagulation in many types of patients with afib, particularly in those who are at high risk for oral anti-coagulation. It can potentially revolutionize how we manage those patients and avoid life long anti-coagulation. The saving realized from reduction in bleeding risk with oral anti-coagulation benefits the patients and society as whole. This is a disruptive technology in afib management!Kovach, RichardTitle: MD, FACC, FSCAI, FACP Chair, Intervent. Cardiology
    Organization: Deborah Heart and Lung Center
    Date: 11/26/2015
    Comment:

    1) Currently I am Chair of Interventional Cardiology at a single specialty heart hospital.

    2) I spend nearly 100% of my time in the cardiac catheterization laboratory or hybrid operating room and perform high volume coronary, peripheral and structural heart interventions.

    3) I have placed multiple Watchman devices and have concluded that, in properly trained hands, this device can be delivered easily and safely in the vast majority of patients with non-valvular AF. The

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    Rinaldi, MichaelTitle: MD
    Organization: Carolinas HealthCare System
    Date: 11/26/2015
    Comment:

    To CMS

    I appreciate the opportunity to comment. I am an interventional cardiologist in practice for 13 years and perform structural heart therapies including left atrial appendage occlusion with the Watchman device. I was an investigator in the PREVAIL study which investigated the safety of the Watchman device and continue to implant the device as an FDA approved commercial therapy. I serve as our Director of Clinical Research for the Sanger Heart and Vascular Institute and have

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    Berkompas, DuaneTitle: MD
    Organization: Spectrum Health
    Date: 11/26/2015
    Comment:

    To: Ms. Tamara Syrek-Jensen, JD
    Director of Coverage & Analysis Group
    From Duane C. Berkompas, MD, FACC
    Chief Division of Cardiology Spectrum Health
    Grand Rapids, MI

    Dear Ms. Syrek-Jensen

    I am sending this comment to ask for your support on the proposed national coverage decision to cover percutaneous LAAC therapy with the Watchman Device.

    As you know, based on several studies, most importantly the PROTECT AF and PREVAIL

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    Morris, DennisTitle: Chairman Cardiovascular Diseases
    Organization: Einstein Medical Center - Philadelphia
    Date: 11/26/2015
    Comment:

    I am Chairman of Cardiovascular Diseases and director of the Insitute for Heart and Vascular Health. Thus I look at this procedure and device from an operator perspective as an interventional cardiologist and from an administrative perspective.

    At Einstein we reat an innercity populationthat is older than the average patient in the US and at a significant lower socio-economic status and in an under served area fo primary care services. This combination provides a difficult

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    Satler, LowellTitle: Director of the Cardiac Cath Labs
    Organization: Washington Hospital Center
    Date: 11/26/2015
    Comment:

    I am currently the director of the cardiac cath lab at the Washington Hospital Center and participated in the WATCHMAN trials.

    I have reviewed the proposal for reimbursem*nt guidelines and find most recommendations for reimbursem*nt both rational and reasonable.The only major ones that need to be contested include:

    1. The selection of patients that have a high HAS-BLED score and are coumadin ineligible. Neither of these were evaluated in the trials. In fact, coumadin

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    Cubeddu, RobertTitle: Head Section, Structural Heart Disease
    Organization: Cleveland Clinic Florida
    Date: 11/25/2015
    Comment:

    In regards to the recently approved LAA Watchman closure procedure(CAG-00445N)and the CMS proposed coverage decision:

    I am an interventional cardiologist and fully trained structural heart interventionalist, currenly working at the Cleveland Clinic Florida, were I serve as Section Head of Structural Heart Disease.

    I have a special interest in Stroke prevention therapies such as Watchman LAA closure procedure. I am actively involved with it commercial use at JFK Medical

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    Sajadi, SaeidTitle: Cardiac Electrophysiologist
    Organization: Phoenixville Hospital
    Date: 11/25/2015
    Comment:

    As a practicing cardiologist and electrophysiologist I treat many patients suffering from atrial fibrillation. Majority of them are at significant risk for stroke. Typically the risk is decreased by treating these patients with anticoagulation therapies. Unfortunately significant number of these patients have high bleeding risk or history of major bleeding. This has prevented many of them from being protected from stroke. Availability of Watchman left atrial appendage closure device has

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    Rogers, JasonTitle: Professor, Cardiovascular Medicine
    Organization: University of California, Davis Medical Center
    Date: 11/25/2015
    Comment:

    Thank for the opportunity to comment on the Proposed Decision Memo for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG-00445N)

    I am an interventional cardiologist at a large tertiary care academic medical center in central California and have been in practice for > 10 years. My focus area of expertise is structural and valvular heart disease.

    My clinical experience with the Watchman device includes participation in the pivotal PROTECT AF trial, the CAP

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    Liu, XiaokeTitle: MD, PhD
    Organization: Borgess Medical Center
    Date: 11/24/2015
    Comment:
    Please consider making revisions to condition No. 2: A CONTRAINDICATION TO COUMADIN. Current Watchman device implant requires using Coumadin for at least 45 days and this would effectively eliminate all patients who may benefit from such a procedure. Please consider changing this to "Not a good candidate for long term Coumadin therapy. Thank you.Ellenbogen, KennethTitle: MD
    Organization: VCU School of Medicine
    Date: 11/24/2015
    Comment:

    Kenneth A. Ellenbogen, M.D.
    kenneth.ellenbogen@vcuhealth.org

    Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG-00445N)

    To: Ms. Tamara Syrek-Jensen, J.D., Director of Coverage & Analysis Group

    Dear Ms. Syrek-Jensen:
    I am currently Chief of Cardiology at the VCU School of Medicine in Richmond, VA. We have a large multi-subspecialty Cardiology Practice at an urban medical center and an affiliated VA Medical Center. I am writing to comment

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    Mounsey, JohnTitle: Professor
    Organization: University of North Carolina
    Date: 11/23/2015
    Comment:

    I strongly support a CMS coverage decision for the Watchman Left atrial appendage occlusion device. I believe the device should be made available to patients with atrial fibrillation unrelated to valvular heart disease who are indicated for long term anticoagulation but where long term anticoagulation is contraindicated because of a bleeding risk or a fall risk. This means patients with atrial fibrillation and a CHADS2 or CHADS2VASc score > or = to 1

    Anticoagulation related

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    Osorio, JoseTitle: Director, Cardiac Electrophysiology
    Organization: Grandview Medical Center
    Date: 11/23/2015
    Comment:

    I would like to make a few comments regarding the draft National Coverage determination for the Watchman left atrial appendage closure device.

    I have extensive experience with atrial fibrillation (having performed over 2000 ablations) as well as managing patients at risk for embolic stroke. I have performed left atrial ligation using the lariat device for over 4 years now. More recently, since june of this year, I started implanting the watchman left atrial closure

    More

    Lim, ScottTitle: MD
    Organization: University
    Date: 11/23/2015
    Comment:
    I believe that this therapy can significantly help our patients with AF and at bleeding risk. The issue remains as to how high a risk warrants LAA occlusion therapy. I think a CHADS2 or CHADSVASC score of > or = 2 is reasonable, although I think a HASBLED score of 3 is a bit too high for some of our patients who would otherwise really benefit.Evonich, RudolphTitle: MD
    Date: 11/22/2015
    Comment:

    Public response RE: Proposed decision memo for percutaneous left atrial appendage closure therapy (CAG-00445N)

    Dear CMS:

    I am writing this response to your proposed decision that “left atrial appendage closure is not reasonable and necessary to treat an illness or improve function and therefore not covered under the social security act.”

    I am a board certified cardiac electrophysiologist and Fellow of the Heart Rhythm Society. My practice is exclusively

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    Beaupre M.D., PaulTitle: CEO
    Organization: Good Samaritan Hospital San Jose California
    Date: 11/20/2015
    Comment:

    I have concerns that meeting requirement Number 2, as it is written, would effectively preclude CMS from paying for Percutaneous LAA Closure Therapy. Currently when the device is deployed, the patient would be placed on Warfarin for up to 6 weeks post procedure to ensure no clot formation on the device. If the device could only be placed in pateints with a contraindication to Warfarin then no device could be deployed effectively denying CMS support for this therapy. I hope CMS will further

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    Wood, FrancesTitle: interventional and structural cardiologist
    Organization: WakeMed
    Date: 11/20/2015
    Comment:

    Re #2. The studies were on increased stroke risk (2 or greater chads) and "not high" as stated in CMS report and HAS-BLED was not used in studies as inclusion/exclusion criteria. There can be strong clinical reasons for LAA occlusion if increased stroke risk without a "high" HAS-BLED. For example, INR hard to control, unable to afford novel agent, inability to get INR checked, side effects to oral agents or falls. The studies used Coumadin for at least 45 days so it cannot be an

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    Siddiqi, FaisalTitle: MD
    Organization: Hamilton Cardiology Associates
    Date: 11/19/2015
    Comment:

    The Watchman has been heavily anticipated among the medical community because it does offer a new hope to provide patients an effective tool at reducing stroke risks and cardiovascular mortality due to atrial fibrillation. Warfarin and NOACs have been a troublesome issue for numerous patients in our population due to bleeding, labile INRs, disruption due to surgery needs, difficulty with transportation to have routine bloodworm, and most importantly costs with respect to NOACs. We have

    More

    Pressman MD, GreggTitle: Associate Director, Echocardiography Laboratory
    Organization: Einstein Medical Center
    Date: 11/19/2015
    Comment:

    I am writing to endorse approval of National Coverage Determination for the Watchman left atrial appendage occluder device (FDA approved). This device represents a significant advance for treatment of patients with non-valvular atrial fibrillation who are at high risk of serious bleeding.

    While I applaud CMS for appreciating the need for this device, I have significant concerns regarding some of the language in the Proposed Decision Memo for Percutaneous Left Atrial Appendage

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    Don, CreightonTitle: Assistant Professor of Medicine (MD)
    Organization: University of Washington
    Date: 11/19/2015
    Comment:

    1. Currently the coverage proposal states that patients must have a 'contraindication to warfarin'. This should read, 'have a compelling to reason to avoid anticoagulation.' One could argue that even patients who have bleeding risks or episodes could still be on warfarin. The patients who benefited from LAAC in PROTECT AF did not have a contraindication to warfarin. Or it should read "Has a high HasBLED score..." OR "a contraindication to warfarin' not AND.

    2. The TSP requirement

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    Sarter, BrianTitle: MD
    Organization: Cardiology Physicians PA
    Date: 11/19/2015
    Comment:

    I am a busy Electrophysiologist practicing in Delaware at Christianacare Hospital. I treat thousands of patients with atrial fibrillation. While I believe the vast majority of patients with atrial fibrillation can be appropriately managed with anticoagulation therapy for stroke prevention, the Percutaneous Left Atrial Appendage Closure device is a critical option for subgroups of these patients. After reviewing CMS proposal for coverage of this therapy I have the following

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    Eckart, RobertTitle: Cardiac Electrophysiologist
    Organization: Heart Specialists of Sarasota, Sarasota Florida
    Date: 11/18/2015
    Comment:

    I am writing to endorse the approval of National Coverage Determination for an FDA approved implantable device for percutaneous left atrial appendage closure for those patients with non-valvular atrial fibrillation for the purpose of reduction of cardioembolic risk of ischemic stroke. While I applaud CMS for appreciating the obvious need for a device of this nature, and the thoroughness of the evidentiary data, I have significant concern with some language within the Proposed Decision Memo

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    Levin, VadimTitle: M.D.
    Organization: PMSI Cardiology
    Date: 11/18/2015
    Comment:

    I am EP physician, practicing in Phoenixville Hospital, PA.
    I am excited and fully supporting CMS proposal for national coverage of the Watchman device.
    Watchman device provide unique stroke prevention therapy for patients who can not take warfarin.
    At the present time, private and HMO type insurances are denying this therapy for very straightforward indications: pt with history of stroke and brain bleeding, was denied.Patient with stroke 1 week after severe GI bleeding,

    More

    NCA - Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG-00445N) (2024)

    FAQs

    What is percutaneous left atrial appendage closure procedure? ›

    The Procedure

    The physician makes a small hole through the wall between the two upper chambers of the heart so that the catheter reaches the left atrium. The physician then pushes the device through the delivery catheter into the left atrial appendage, where it opens up like an umbrella and is permanently implanted.

    What is the recovery time for left atrial appendage closure? ›

    Within two weeks of surgery, you will have a follow-up appointment to remove your stitches. We may also schedule you to start cardiac rehabilitation to support your recovery, if needed. You should be able to resume most of your normal activities about a week after surgery.

    What is the purpose of the left atrial appendage closure? ›

    A nonpharmacological option is available for patients with nonvalvular Afib who are at high risk for stroke: left atrial appendage closure (LAAC). LAAC is a minimally invasive procedure that seals off the left atrial appendage of the heart to prevent blood from pooling and creating blood clots.

    What is the success rate of left atrial appendage closure? ›

    The primary end point was LAA closure as determined by TEE after 2 months post procedure and stroke rate at 150 patient‐years. LAA occlusion was successful in 90% of the patients (95% CI, 83.1%–92.9%).

    What are the downsides of the watchman? ›

    Rare risks of the WATCHMAN procedure include: Blood clots. Infection. Pericardial effusion, a buildup of fluid in the membranes around your heart.

    What is the recovery time after having a watchman procedure? ›

    How long does it take to recover after the Watchman procedure? Recovery from the procedure is quick, so you should be able to resume your normal activities of daily living after about 24 hours. We recommend no heavy lifting and pulling for seven days.

    What are the problems with left atrial appendage? ›

    Because the left atrial appendage is a little pouch, blood collects there and can form clots in the LAA and atria. When your heart pumps out blood clots, they can cause a stroke. People with atrial fibrillation are three to five times more likely to have a stroke than the general population.

    Which is safer, Eliquis or Watchman? ›

    Apixaban (Eliquis) was the safest, followed by edoxaban (Savaysa), dabigatran (Pradaxa), warfarin (Coumadin) and then rivaroxaban (Xarelto); the Watchman device ranked last. The Watchman device has been advertised heavily, both to the public, in medical journals, and at medical conferences.

    Does left atrial appendage removal prevent strokes? ›

    Surgical occlusion of the left atrial appendage reduces the risk of stroke by means of a different mechanism from that of anticoagulants, and its effects appear to be additive to those of oral anticoagulation.

    What are the 4 types of left atrial appendage? ›

    Following large imaging cohorts of patients, four main LAA morphologies have been classified: chicken wing, cactus, windsock, and califlower - the former of these four being the most prevelant found in 48% of patients and the other found in 30%, 19%, and 3%, respectively[24].

    Can you still have a stroke with a watchman? ›

    The WATCHMAN Implant effectively reduces the risk of stroke—without the risk of bleeding that can come with the long-term use of blood thinners.

    Do I need my left atrial appendage? ›

    Like your appendix, your left atrial appendage doesn't really have a clear role to play in your body.

    Which is better watchman or AtriClip? ›

    The AtriClip is placed from the outside of the heart around the appendage. The anatomy of each individual's left atrial appendage dictates which closure procedure will have the best outcome. “Both devices are equally effective in preventing strokes,” Dr.

    How much does a left atrial appendage closure device cost? ›

    How Much Does a Left Atrial Appendage Closure (LAAC) Cost? On MDsave, the cost of a Left Atrial Appendage Closure (LAAC) is $38,850. Those on high deductible health plans or without insurance can shop, compare prices and save.

    What percentage of clots are in the left atrial appendage? ›

    If these clots end up in the brain, they can block blood flow and cause a stroke. Researchers believe that up to 90 percent of these clots form in the left atrial appendage, a hollowed-out, fingerlike outpouching attached to the left atrium, one of the upper chambers of the heart.

    Who is a candidate for the watchman procedure? ›

    Your cardiologist may recommend the WATCHMAN procedure if: You are at increased risk of stroke. You have non-valvular A-Fib (A-Fib not caused by a heart valve problem) You have a history of bleeding or a job or lifestyle that puts you at risk for bleeding.

    What is the difference between Watchman and AtriClip? ›

    The WATCHMAN device is an umbrella-like mechanism that is implanted with a catheter inside the left atrial appendage and expands inside it to seal it off. The AtriClip is placed from the outside of the heart around the appendage.

    What happens to left atrial appendage after Watchman procedure? ›

    The Watchman implant closes off the left atrial appendage (LAA). After about 45 days, heart tissue grows over the implant to form a barrier to prevent blood clots from escaping into the blood stream.

    What are the side effects of the Amplatzer amulet? ›

    Potential adverse events that may occur during or after a procedure using this device include, but are not limited to: air bubble that blocks blood flow in a vessel; allergic reaction; anesthesia reactions; nausea; confusion; injury to the airway; difficulty breathing; fainting; loss of regular heart rhythm; a hole in ...

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