ABOUT 'BEAT YOUR A-FIB'...


"This book is incredibly complete and easy-to-understand for anybody. I certainly recommend it for patients who want to know more about atrial fibrillation than what they will learn from doctors...."

Pierre Jaïs, M.D. Professor of Cardiology, Haut-Lévêque Hospital, Bordeaux, France

"Dear Steve, I saw a patient this morning with your book [in hand] and highlights throughout. She loves it and finds it very useful to help her in dealing with atrial fibrillation."

Dr. Wilber Su Cavanaugh Heart Center, Phoenix, AZ

"Your book [Beat Your A-Fib] is the quintessential most important guide not only for the individual experiencing atrial fibrillation and his family, but also for primary physicians, and cardiologists."

Jane-Alexandra Krehbiel, nurse, blogger and author "Rational Preparedness: A Primer to Preparedness"



ABOUT A-FIB.COM...


"Steve Ryan's summaries of the Boston A-Fib Symposium are terrific. Steve has the ability to synthesize and communicate accurately in clear and simple terms the essence of complex subjects. This is an exceptional skill and a great service to patients with atrial fibrillation."

Dr. Jeremy Ruskin of Mass. General Hospital and Harvard Medical School

"I love your [A-fib.com] website, Patti and Steve! An excellent resource for anybody seeking credible science on atrial fibrillation plus compelling real-life stories from others living with A-Fib. Congratulations…"

Carolyn Thomas, blogger and heart attack survivor; MyHeartSisters.org

"Steve, your website was so helpful. Thank you! After two ablations I am now A-fib free. You are a great help to a lot of people, keep up the good work."

Terry Traver, former A-Fib patient

"If you want to do some research on AF go to A-Fib.com by Steve Ryan, this site was a big help to me, and helped me be free of AF."

Roy Salmon Patient, A-Fib Free; pacemakerclub.com, Sept. 2013


PREVAIL

Getting FDA Approval for the Watchman Device

AF Symposium 2015

Getting FDA Approval for the Watchman Device

by Steve S. Ryan, PhD, February 2015

Vivek Reddy Mt Siani Hospital

Dr Vivek Reddy Mt Sinai Hospital

The Watchman device is in the last stages of the approval process from the FDA. This is a true “tipping point” in the development of devices to help A-Fib patients (The Watchman is approved everywhere else in the world).  If (or rather when) the Watchman is approved in the U.S., it will be because of the dedicated, thorough research of Dr. Vivek Reddy and his many colleagues and researchers.
(Added March 2015: The FDA approved the Watchman Device March 2015. See http://a-fib.com/my-2015-top-five-list-of-a-fib-advancements/)

Dr. Vivek Reddy of Mount Sinai Hospital gave a historically important talk entitled “5 Year Follow-Up Data On Watchman in Coumadin Eligible Patients.” He discussed the two major clinical trials of the Watchman device—PROTECT-AF and PREVAIL.

PROTECT-AF

In PROTECT-AF, patients who were followed for five years had less strokes (Primary Efficacy Endpoint) than those in the warfarin arm and there were less deaths. (Reddy, V. et al. JAMA. 312:1988 [2014])

PREVAIL

Reddy Watchman 1 500 pix at 96 resThe PREVIAL clinical trial was a smaller study designed to confirm the results of the PROTECT-AF trial and validate the safety of the implant procedure. With regards to the Primary Efficacy Endpoint (composite of all stroke, systemic embolism, and cardiovascular/unexplained death at 18 months), “non-inferiority was not achieved.” In other words, the Watchman group performed slightly worse than the warfarin control group.

But for some reason the warfarin control group performed much better than in any other trial. The Ischemic Stroke Rate per 100 patient-years was 1.1 in PROTECT-AF, while in PREVAIL it was only 0.3. In other words, the warfarin control group in PREVAIL overperformed compared to any other clinical trial.

Dr. Reddy pointed out to the FDA panel October, 2014 that the longer-term follow-up of the PROTECT-AF trial confirmed the efficacy of the Watchman therapy, even though the PREVAIL trial trended negative compared to the warfarin control group. But this particular PREVAIL warfarin control group was “unusual” and performed much better than expected.

Looking at other adverse events, the hemorrhagic stroke rate was 0.4% for the Watchman arm and 0.7% for the warfarin control group.

The Cardiovascular Death rate was 1.4% for the Watchman vs. 2.3% for warfarin.

Combining PROTECT-AF and PREVAIL

Reddy Watchman 2 500 pix wide by 96 resWhen you combine the PROTECT-AF and PREVAIL studies even with the “unusual” PREVAIL warfarin control arm results, “All Stroke” is non-inferior or about the same for both arms.

Also, as one would expect, after 6-months post implant, the Watchman arm had significantly less bleeding events than warfarin.

Early Safety Endpoint Achieved

The Early Safety Endpoint in PREVAIL was achieved.

• There was a significant increase in inplant success rate (95.1%) compared to PROTECT-AF (90.9%). There was no significant difference in complication rates between experienced and new implanters, demonstrating the success of the physician training program. Following successful implantation, 99.3% of patients were able to discontinue warfarin after 12 months.

• There was a 52% reduction in procedure/device related vascular complications (1.9% in PREVAIL vs, 4.0% in PROTECT-AF).

• There was a 52% reduction in pericardial effusions requiring intervention and at a rate comparable to other left atrial procedures.

Editor’s Comments:
Because of a freak statistical accident, the warfarin arm in the PREVAIL trial performed much better than expected and much better than in any previous trials. Perhaps if the PREVAIL trial were longer or had more subjects, the results might approach the longer PROTECT-AF trial. One shouldn’t interpret the results of PREVAIL as negating the conclusive results of the longer PROTECT-AF trial. In PREVIAL the Watchman device performed just as well as in PROTECT-AF. Only the warfarin control arm was different.
The most significant finding of PREVAIL was the the Early Safety Endpoints were achieved. That was the primary reason the FDA wanted the PREVAIL study in the first place.
Thanks to the excellent research and presentation by Dr. Reddy and his colleagues before the FDA, I’ll go out on a limb and predict the FDA will approve the Watchman device, probably by the middle of 2015.
The Watchman device closes off the LAA where 90-95% of A-Fib strokes come from. It’s a very low risk procedure that takes as little as 20 minutes to install. Afterward, you would usually not need to be on blood thinners. (For more, see my article, The Watchman Device: The Alternative to Blood Thinners).
If the FDA were to not approve the Watchman, this would be a major setback in the treatment of A-Fib in the US. The Watchman is approved everywhere else in the world. One would have to go to Canada or overseas to get the Watchman installed.
NOTE: Dr. Reddy also discussed this topic in February at the 2015 International Symposium on Left Atrial Appendage (ISLLA) held in Marina Del Rey, CA.

Back to top

Return to: AF Symposium: Steve’s In-Depth Reports Written for Patients

Last updated: Friday, November 11, 2016

Follow Us
facebook block 65 pix REVtwitter block 65 pixlinkedin block 65 pixpinterest.block 65 pix


A-Fib.com is a
501(c)(3) Nonprofit



Your support is needed. Every donation helps, even just $1.00.


We Need You
A-Fib.com Mission Statement
BYA - Alerts ad Green

A-Fib.com top rated by Healthline.com for the third year.
A-Fib.com top rated by Healthline.com for the third year. 2014  2015  2016

Mug - Seek your cure - Beat Your A-Fib 200 pix wide at 300 resEncourage others
with A-Fib
click to order

Home | The A-Fib Coach | Help Support A-Fib.com | A-Fib News Archive | Tell Us What You think | Media Room | GuideStar Seal | HON certification | Disclosures | Terms of Use | Privacy Policy