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Dr. Vivek Reddy

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 Siani 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.

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.

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

Last updated: Wednesday, April 22, 2015

AF Symposium 2015 Brief Reports by Steve S. Ryan, PhD

20th Annual AF Symposium

by Steve S. Ryan, PhD

This overview should give you a sense of the topics floating through the three days in Orlando and the over sixty presentations by fifty A-Fib experts and researchers. (Most recent brief reports listed first)

AF Symposium: My Brief Reports

 The Novel Oral Anticoagulants: Xarelto Best Seller; Dr. Daniel Singer
 Stimulating the Front Ear Flap Inhibits A-Fib—Research by Dr. Warren Jackman
 Dr. Ruskin Asked: Can Anyone in A-Fib Really Be Asymptomatic?
 The Rhythmia 3-Dimensional Mapping System (Live from Leipzig via Satellite) 
 LAA Occlusion Devices: Is the Watchman Device Dead in the Water?
 FDA ‘Easy Feasibility Study’ (EFS 
 Reversal Agents for the New Anticoagulants (NOACs)? 
 Female Gender: Is it a Risk Factor for Stroke?
 Living in A-Fib More Dangerous Than Having an Ablation
 Rotors! Rotors! Rotors! Sizzling Topic but No Consensus
 Holistic Approach to Health: Great Results Dealing with Obesity
 Atrial Esophageal Fistula: A Case Study
 Anticoagulation Case Study: Dilemma for 92-year-old With Paroxysmal A-Fib
 Ablation Without X-Ray or Fluoroscopy (Live via Satellite)
 From Beijing: Strange Chinese Case (Live via Satellite)
 Ablation & Closing Off the Left Atrial Appendage in the Same Procedure (Live via Satellite)
 Contact Force Sensing and Jet Ventilation (Live Satellite Presentation)
 Non-Invasive Electrocardiographic Imaging—ECGI—CardioInsight
 Fibrosis and A-Fib: Continuing Research on Sheep

The Rhythmia 3-Dimensional Mapping System (Live from Leipzig via Satellite)

Rhythmia 3-Dimensional Mapping image

Image from Rhythmia 3-Dimensional Mapping system by Medtronic

Live Via Satellite TV icon(Please be advised that the Symposium organizers go to great lengths not to identify or unfairly publicize one device over another. When writing these reports I often have to do a good deal of research to correctly identify and describe particular devices that are demonstrated, as a service to readers. But this in no way implies or suggests that one device is superior to another.)

Dr. Gerhard Hindricks of the University of Leipzig in Germany gave a dynamic presentation of a catheter ablation of a 46-year-old female with paroxysmal A-Fib using the Rhythmia 3-dimensional multipolar mapping system by Boston Scientific. Along with his colleagues Drs. Andreas Bollmann and Jedrzej Kosiuk, they used the Rhythmia special basket catheter to generate a 3-D map of electrogram voltages and activation times. To me it seemed amazingly fast. The eight-splined bidirectional catheter produced 1,000 data points per minute. In what seemed like only a few passes, they produced a 3-D color reconstruction of the patient’s left atrium.

The actual ablation was routine. They terminated the A-Fib into sinus rhythm without having to use Electrocardioversion. But they found that the PV isolation was incomplete. Using the same Rhythmia 3-D mapping catheter, they were easily and quickly able to locate the gap in the Left Superior PV and ablate it.

LAA Occlusion Devices: Is the Watchman Device Dead in the Water?

Dr. Vivek Reddy from Mount Sinai School of Medicine in New York City gave a very well referenced and persuasive presentation on the Watchman device which closes off the Left Atrial Appendage to prevent clots and strokes. The theory behind the Watchman device is that most A-Fib clots originate in the Left Atrial Appendage (LAA). The Watchman 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).

Dr. Reddy certainly persuaded me that the FDA should approve the Watchman device. Dr. Reddy, earlier in Washington, had made the same persuasive arguments before the FDA.

Dr. Andrew Farb from the FDA took the bull by the horns and gave his perspective on the various LAA Closure (Occlusion) Devices. But as one would expect, he didn’t indicate how the FDA would rule on the Watchman device, since deliberations were still ongoing.

After his presentation, I asked him several pointed questions about this, but he was, of course, careful not to comment about current FDA deliberations. My guess? If body language, momentum, mood of the presentations, and more importantly recent research indicate anything, the Watchman device probably will not be approved by the FDA.

There was a palpable sense of sadness at the end of these presentations. The attendees realized that the game may be over for the Watchman device. I hope I am wrong, since the Watchman device would be an important tool to help A-Fib patients. Once the FDA rules and the current clinical trials of the Watchman device end, you will probably have to go to Canada or overseas to get a Watchman device installed.

Watchman May Win FDA Approval

Updated March 13, 2015: The Watchman Device by Boston Scientific finally wins FDA approval

In my earlier brief reports on the Orlando AF Symposium, based on the recent research and the FDA presentation, I said the Watchman device probably won’t be approved in the US. I’m happy to say that I am most likely wrong.

At the LAA Symposium 2015 in Marina del Rey, CA, it was suggested that the Watchman device may be approved by the middle of this year. One presenter described how the FDA chairman talked with several people who were going to Canada to have the Watchman device installed. He seemed embarrassed that the Watchman was available everywhere in the world but not in the US and said that it has to be approved.

Other doctors I talked with at the LAA Symposium were of the same opinion. Presenters described how clinical trials for other LAA closure devices were on hold so that they could get approved in comparison to the Watchman (Non-Inferiority Trials). Dr. Dhanunjaya Lakkireddy of the University of Kansas Medical Center said that we are at a “tipping point” for the (A-Fib) industry.

FDA ‘Easy Feasibility Study’ (EFS)

As everyone, including the FDA, is well aware, A-Fib innovations usually start in Europe where they are more easily approved. Then only later do they move to the US for FDA approval, since the FDA generally requires more data than European regulators.

Drs. Jun Dong and Andrew Farb from the FDA described the FDA’s ‘Easy Feasibility Study’ (EFS) program where medical device innovations could be evaluated  in the US without having to go to Europe first. He encouraged researchers and attendees to take advantage of the new EFS program. This is major news and may make the development of A-Fib innovations much easier to accomplish in the US.

For further information, contact: Andrew Farb, Email: Andrew.farb@fda.hss.gov. 301-796-6317

Reversal Agents for the New Anticoagulants (NOACs)?

Dr. Luigi Di Biase from the Albert Einstein College of Medicine in the Bronx, NY and Dr. Daniel Singer from Massachusetts General Hospital in Boston each described potentially great developments in reversal agents for apixaban (Eliquis) and rivaroxaban (Xarelto).

Dr. Di Biase described studies where leaving people on uninterrupted rivaroxaban and apixaban before, during and after an ablation dramatically reduced the amount of silent thromboembolic lesions and were as safe as warfarin with regards to stroke and TIAs. (This didn’t work with dabigatran [Pradaxa].) But if patients develop bleeding or effusion during the ablation, they are in trouble because there is no direct reversal agent as there is for warfarin. He has used Factor IV as an indirect reversal agent. Dr. Singer also described how Factor IV was used as a reversal agent for apixaban.

But there are new reversal agents for apixaban and rivaroxaban which promise to completely reverse the effects of these two drugs in less than four minutes. The FDA is speeding up studies on these reversal agents. But one never knows when or if the FDA will approve them.

Female Gender: Is it a Risk Factor for Stroke?

Dr. John Day of the Intermountain Heart Institute in Murray, UT (and recently elected president of the Heart Rhythm Society) may be the first A-Fib leader to publicly question whether women should be given one point on the stroke risk CHA2DS2-VASc scale just because of their gender. Many doctors have said this in a circumspect way. Dr. Eric Prystowsky in a presentation at last year’s AHS meeting thought that most doctors would agree with Dr. Day, “as long as there wasn’t a camera focused on them.” He gave the example of a 45-year-old woman in good health and a 45-year-old man with hypertension who according to current guidelines should both be given one point on the stroke risk CHA2DS2-VASc score.

Editor’s Comments:
As readers of A-Fib.com, you know that’s been my opinion ever since the original European guidelines came out. Women in their child-bearing years are much less at risk of stroke because of the blood-thinning effect of losing blood each month. And even after menopause women have less risk of stroke. But eventually they do have more strokes. But not because of an innate inferiority, but because women live longer than men. Stroke is age related. An observational Danish registry study documents this.
For more, see The Denmark Study: Women in A-Fib Not at Greater Risk of Stroke Contrary to CHA2DS2-VASc Guidelines!) (Be advised that the original European guidelines were written by doctors with major conflicts of interest.) These guidelines may be a not so very subtle form of gender bias.

Living in A-Fib More Dangerous Than Having an Ablation

Living in A-Fib is more dangerous than having an ablation, according to Dr. Josef Kautzner from Prague, the Czech Republic. Studies have documented that the adverse effects of living in A-Fib, having to take A-Fib drugs and anticoagulants for life are both pragmatically and statistically worse than having an ablation. Dr. Kautzner discussed how A-Fib can cause or is associated with silent brain lesions and dementia. Any time you go into a hospital is a risk. And no one would say that a catheter ablation is a walk in the park. But an ablation is a low risk procedure, though not risk free. The risk is similar to having your tubes tied. The possible adverse effects of an ablation procedure (like bleeding at the groin) are generally temporary, unlike the lasting, permanent damage you can do to your heart, body and brain by living in A-Fib for years.

Rotors! Rotors! Rotors! Sizzling Topic but No Consensus

The most hotly discussed topic at this year’s symposium was rotors. The opinions expressed about rotors were at times very heated, more than I had ever seen at an AF Symposium. Dr. Shih-Ann Chen of Taipei, Taiwan disagreed with Dr. Sanjiv Narayan of Stanford, CA about the basic concepts of rotors and how they should be defined. Dr. Ravi Mandapati of UCLA and Loma Linda University disagreed with Dr. Narayan which was all the more striking in that he had worked with Dr. Narayan when he was at UCLA. Dr. Pierre Jais of Bordeaux, France said that the FIRM mapping system misses 40% of the atrium area.

Drs. Haissaguerre and Jais from Bordeaux and Dr. Sebastien Knecht of Brussels, Belgium gave presentations on how they were using the CardioInsight body surface mapping vest to perform ablations of “drivers” at many different centers, while Dr. Karl-Heinz Kuck from Hamburg, Germany using a different body surface mapping system said that he couldn’t ablate rotors. Dr. Narayan says the FIRM system finds a maximum of 2-3 rotors in the atria, while other systems find as many as seven. The FIRM system says rotors are usually relatively stable and can last as long as 30 seconds while others say they rotate in one fixed spot for only one or two rotations, that they tend to migrate within a certain area.

The presenters obviously didn’t share a consensus of basic concepts of what rotors are, how they work, their importance in A-Fib, how they should be correctly identified, used, and ablated. (It seems to me the Bordeaux group has the best understanding and pragmatic use of rotors. They refer to “rotors” and focal sources as “drivers.”) But the CardioInsight system Bordeaux uses isn’t currently available or isn’t being tested in the US.

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Holistic Approach to Health: Great Results Dealing with Obesity

Obesity was one of the most often discussed topics. There is a growing consensus among EPs that it isn’t enough to just give obese patients a catheter ablation while not dealing with their obesity. If the obesity isn’t dealt with, their A-Fib is very likely to re-occur. A-Fib will develop in other spots that haven’t been ablated. The condition (obesity) that triggered or caused the A-Fib will trigger or cause it again, if it isn’t taken care of.

Dr. Prashanthan Sanders of Adelaide, Australia described the great results he is getting in his clinic which includes a weight loss program and counseling. He convinces his overweight patients to buy into the program, lose weight, and keep it off. The program works so well that just by losing weight patients become A-Fib free. This program is a holistic approach to health and also is developed to work for diabetes, sleep apnea, hypertension, binge drinking and smoking.

Dr. Sanders foresees a world where some patients become A-Fib free simply by changing their life style, where they don’t have to have a catheter ablation to become A-Fib free.

Many other doctors commented that A-Fib treatment at many centers today includes or should include much more than A-Fib ablation and drugs. A-Fib centers should have nutritionists, exercise therapists, sleep apnea specialists, etc. as part of their A-Fib program.

Atrial Esophageal Fistula: A Case Study

Dr. John Day of the Intermountain Heart Institute in the Challenging Cases Discussion described his experience with the dreaded Atrial Esophageal Fistula. Though very rare, this is one of the few possible complications of a catheter ablation that can kill you. An ablation, if not done with caution, can irritate and damage the esophagus which often lies right next to the heart. Over 2-3 weeks stomach acid can eat through this damaged area to produce a hole or fistula from the esophagus into the heart.

As soon as Dr. Day saw this patient, he knew it was a fistula and immediately called surgeons and a GI doctor. All the surgeons were doing operations and didn’t want to do the surgery in the EP lab. Dr. Day described how he and his colleagues ran down the hospital hallway to the operating room while giving the patient a transfusion and at the same time pumping out the blood escaping from his heart.

The GI doctor got there first and put in a stent in the esophagus to plug the hole. There was lots of discussion as to whether this was the best approach, but it worked. The patient survived but had to spend a month in the hospital.

This cautionary and very dramatic tale certainly got the attention of all the attendees. No matter how rare a fistula is, every EP and A-Fib center must have an established protocol in place to deal with it. I remember Dr. Hugh Calkins in a previous Symposium advising, “There are only two kinds of EPs—those who have not had an Atrial Esophageal Fistula and those who have!” (Dr. Calkins’ patient with fistula also survived.)

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Anticoagulation Case Study: Dilemma for 92-year-old With Paroxysmal A-Fib

Dr. Peter Kowey of Lankenau Hospital in Winnewood, PA described a case that illustrates the kind of dilemma both doctors and patients often have to face. A 92-year-old woman with paroxysmal A-Fib who had been treated for many years with warfarin had some bruising and nuisance bleeding, but never anything major.

Dr. Kowey thought that ethically he should tell her about the different new anticoagulants which may be superior to warfarin, then see if she wanted to change. She went with apixaban (Eliquis), then six months later had a stroke even though she was taking apixaban properly and conscientiously. Happily, she made an almost full recovery. She returned to warfarin which had worked for her in the past and which she was comfortable using.

Editor’s Comments:
One of the reasons Dr. Kowey discussed the new anticoagulants with his 92-year-old patient was because warfarin is considered more apt to cause bleeding in older patients. The newer anticoagulants in clinical trials caused less bleeding. But we don’t have much data from the clinical trials on people over 90 years old.
Can we say that apixaban didn’t work or was ineffective? No. Anticoagulants reduce but do not totally eliminate the risk of an A-Fib stroke. Just because she had a stroke doesn’t mean apixaban didn’t work.
Dr. Jeremy Ruskin pointed out that there has never been and probably never will be a head-to-head comparison of the three new anticoagulants. But in my opinion apixaban (Eliquis) appears to have tested better and is safer than the others
For more, see my 2013 BAFS articles, The New Anticoagulants (NOACs) and Warfarin vs. Pradaxa and the Other New Anticoagulants.

Ablation Without X-Ray or Fluoroscopy (Live via Satellite)

Live Via Satellite TV iconIn the satellite case live presentations, Drs. Rodney Horton and Amin Al-Ahmad from the Texas Cardiac Arrhythmia Institute in Austin, TX surprised us by doing an ablation without wearing the standard lead aprons to prevent fluoroscopy exposure. Even more surprising was one of the lab assistants who was pregnant. She could work on the ablation because no fluoroscopy was used. The doctors did the whole ablation using ICE (Intracardiac Echo) and 3D mapping. They showed for example how ICE can be used to thread the catheter up into the heart and into the left atrium. Dr. Horton said that not having to wear those heavy lead aprons would probably add 5-10 years to his ablation career.

(They didn’t wear surgical masks during the ablation which was surprising to me. I will write them for an explanation.)

From Beijing: Strange Chinese Case (Live via Satellite)

Live Via Satellite TV iconThe live satellite case from Beijing, China was technically flawless and probably a first of its kind. But it wasn’t much of a learning experience for the attendees. The Chinese EPs only used one catheter and had to frequently pull out the mapping catheter and replace it with the ablation catheter, etc. When the expert panel asked them questions, the Chinese EPs either didn’t understand or simply didn’t answer them. They seemed very uncomfortable. It seemed like a throwback to ablation techniques of 20 years ago.

Ablation and Closing Off the Left Atrial Appendage in the Same Procedure (Live via Satellite)

Live Via Satellite TV iconDrs. Claudio Tondo, Gaetano Fassini, Massimo Moltrasio, and Antonio Dello Russo from Milan, Italy showed how they do a catheter ablation for A-Fib and install the Watchman device in the same procedure, when it’s needed. They do the ablation procedure first. Then when the patient is in sinus rhythm, they install the Watchman device. (This can’t be done in the US, because the Watchman device hasn’t received FDA approval. In later discussions including representatives of the FDA, there was an all too real possibility that the Watchman will never receive FDA approval.)

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Contact Force Sensing and Jet Ventilation (Live Satellite Presentation)

Image of the TactiCath Quartz irrigated ablation catheter with EnSite Contact Force Module (Photo St. Jude Medical, Inc.)

TactiCath Quartz irrigated ablation catheter with EnSite Contact Force Module (Photo St. Jude Medical, Inc.)

Live Via Satellite TV icon Drs. Kevin Heist and Moussa Mansour from Massachusetts General in Boston showed in a live case how they used a Contact Force Sensing catheter combined with Jet Ventilation. (There are two Contact Force Sensing catheters approved by the FDA—the ThermoCool Smart Touch device by Biosense Webster (approved Feb. 24, 2014) and the TactiCath Quartz Contact Force Ablation Catheter by St. Jude Medical (approved Oct. 27, 2014). This live case used the TactiCath catheter but didn’t imply or suggest it is superior to the ThermoCool catheter. For a description of each, see my 2014 AF Symposium report The New Era of Catheter Ablation Technology: Force Sensing Catheters.

This combination of Force Sensing Catheter with Jet Ventilation for RF ablation probably represents the most advanced RF ablation strategy available today. Jet Ventilation doesn’t stop the heart from beating as in bypass surgery. But to this observer it seemed to put the heart in a type of slow motion with a lot less movement than when the heart is beating in normal sinus rhythm. You could really see a difference when they turned the Jet Ventilation off and on. Slowing down the heart like this helps the ablation doctor make lesions in hard-to-access areas and makes it easier to hold the catheter steady and apply the right contact pressure.

Non-Invasive Electrocardiographic Imaging—ECGI—CardioInsight

Drs. Michel Haissaguerre and Pierre Jais from Bordeaux/LYRIC gave presentations on the ECGI system. The day before their ablation, the patient lies down on his/her back and a technician places a vest-like device with 256 electrodes over his/her chest and stomach. These electrodes combine with rapid CT (Computed Tomography) scans to produce a very detailed 3D color map of the heart. (For a detailed description and discussion of the ECGI system, see 2013 BAFS: Non-Invasive Electrocardiographic Imaging [ECG]) The system automatically detects rotors and foci and computes them into a “Cumulative Map” or movie. These driver regions are ranked, based on statistical prevalence.

Then, Dr. Sebastien Knecht from CHU Brugmann, Brussels, Belgium, described the AFACART trial design and preliminary results using the CardioInsight ECGI system. Many centers in Europe including four in Germany are now using the CardioInsight. Requiring very little training, technicians and EPs using the CardioInsight system are getting similar great results like the Bordeaux group. Though these studies just started, it looks like the CardioInsight ECGI mapping and ablation system is poised to revolutionize the way EPs map and perform ablations.

Fibrosis and A-Fib: Continuing Research on Sheep

Dr. Jose Jalife of the University of Michigan in Ann Arbor, MI, continued his exciting research on fibrosis and A-Fib. In previous Symposiums Dr. Jalife demonstrated how A-Fib produces fibrosis. When he paced sheep into A-Fib, their hearts became fibrotic within a very short time. The markers of fibrosis (collagen and scarring) increased progressively as the sheep went from paroxysmal to persistent A-Fib. (See A-Fib Produces Fibrosis—Experimental and Real-World Data.)

Fibrosis is tissue that has fiber-like characteristics which develop in place of the normal smooth walls of the heart. Fibrotic tissue is scarred, immobile, basically dead tissue with reduced or no blood flow and no transport function. It results in a loss of atrial muscle mass. Over time it makes the heart stiff, less flexible and weak, overworks the heart, reduces pumping efficiency and leads to other heart problems. Fibrosis, up to now, was considered permanent and irreversible. But Dr. Jalife gave his sheep a Gal-3 inhibitor GM-CT-01 that actually prevented and reduced fibrosis! (For his previous presentations, see 2014 BAFS: The Holy Grail: Preventing A-Fib by a GAL-3 Inhibitor.)

In his continuing studies of sheep, Dr. Jalife found that fibrosis predicts recurrence, and that fibrosis can not be reversed if it is well established, even with GAL-3 Inhibitors.

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Last updated: Thursday, January 21, 2016 

A-Fib Producing Spots Outside the Pulmonary Veins – 2014 Boston AF Symposium

Vivek Reddy Mt Sinai Hospital

Dr Vivek Reddy Mt Sinai Hospital

2014 Boston AF Symposium

A-Fib Producing Spots Outside the Pulmonary Veins

Report by Dr. Steve S. Ryan, PhD

Dr. Vivek Reddy of Mount Sinai Hospital in New York gave a presentation entitled “What is the true rate of Non-PV triggers?”

Why do ablations fail?

Dr. Reddy posed the question, ‘Why do ablations fail?’ The most common reason is a gap in an ablation lesion. Dr. Reddy showed slides of a typical wide area antrum isolation ablation with remarkably precise point-by-point burns. But there was a slight gap which let A-Fib signals escape from the pulmonary veins into the rest of the heart. But Non-PV triggers can also cause ablation failure.

Dr. Reddy asked the BAFS attendees:

“What is the rate of non-PV triggers after an extra-ostial PV isolation procedure?”

The choices ranged from 5% to over 25%.

The actual rate of non-PV triggers is approximately 23%.

Carina important origin of A-Fib triggers

Dr. Reddy showed how the ‘carina’ (the area in the heart between the left and right pulmonary vein openings) is often a source of A-Fib triggers and of recurrence after an ablation. According to the study cited, “the carina region (has an) apparently unique electrical behavior.” To effectively isolate PVs, it is frequently necessary to target within the circumferentially ablated veins in the carina region, even though there is a risk of stenosis.

Where are the non-PV triggers usually from?

In an older study of 248 Paroxysmal A-Fib patients, 28% had non-PV triggers. (These earlier studies often used segmental or ostial isolation and weren’t as durable as later procedures.) The most common locations were:

▪  LA Posterior Free Wall: 38% ▪  Superior Vena Cava: 37% ▪  Crista Terminalis: 13.7% ▪  Ligament of Marshall: 8.2%

(In this study, the Carina area and newer areas of interest such as the Left Atrial Appendage were not mentioned)

Left Atrial Appendage (LAA)

In a study of nearly 4,000 A-Fib patients that looked at redo procedures for paroxysmal, persistent and long-term persistent A-Fib, 27% had LAA firing (the LAA is the source of arrhythmia), much more in the long-term persistent (58%) compared to paroxysmal (18%). Most wound up having a LAA isolation procedure. (Many centers, as part of their protocol, now routinely first look at the LAA after isolating the PVs. See Bordeaux Five-Step Ablation Protocol for Chronic A-Fib.)

Age Dependent

Paroxysmal patients over 80 years old had many more non-PV triggers than other patients.

Recurrence Associated with Predominately Non-PV Triggers

In a study of 197 paroxysmal A-Fib patients from 2009 to 2012 using irrigated tip RF catheters and extraostial PV isolation, there were non-PV triggers in 23.7% of patients. In patients who had recurrence, 70.8% had non-PV triggers.

 In patients who had recurrence, 70.8% had non-PV triggers.

Editor’s Comments:
Dr. Reddy’s research is important for EPs who will now look more closely at areas like the Carina and the Left Atrial Appendage to find and ablate/isolate non-PV triggers.
What does Dr. Reddy’s research mean for patients? Since 23% of A-Fib ablation triggers are found in other areas of the heart than the pulmonary veins, a simple Pulmonary Vein Isolation (PVI) or Maze surgery may not be enough to cure your A-Fib.
One of the most important findings of Dr. Reddy’s research is that recurrence (a failed ablation) is most often associated with non-PV triggers (70.8%). When searching for the right Electrophysiologist (EP) to do your ablation, they have to have experience in tracking down these non-PV triggers. When interviewing EPs, maybe one of the questions needs to be “How often do you find non-PV triggers? How do you track them down and ablate them?”
You should probably avoid any EP who only isolates the PVs. [I’ve read Operating Room reports from EPs who only do a PVI, never look for non-PV triggers, and don’t terminate the A-Fib by ablation. Instead they shock the patients back into sinus rhythm, then load them up with powerful but toxic antiarrhythmic meds like amiodarone. This usually doesn’t work.)
If you are considering (Wolf) Mini-Maze surgery, be aware that most Mini-Maze surgeries only isolate the PVs. Your chances of having non-PV triggers which a Mini-Maze surgery will not ablate/isolate are approximately 23%. That translates to at least a 23% chance of failure.
If you have non-PV triggers or A-Fib/Flutter coming from the right atrium, most Maze surgeries won’t make you A-Fib free. Surgeons currently do not access the right atrium during most Maze surgeries. To take care of these other A-Fib spots, you will have to schedule a catheter ablation.
References for this article

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Last updated: Friday, August 28, 2015 

Renal Sympathetic Denervation (RSDN) for A-Fib? – 2014 Boston AF Symposium

Vivek Reddy Mt Siani Hospital

Dr Vivek Reddy Mt Sinai Hospital

Boston AF Symposium 2014

Renal Sympathetic Denervation (RSDN) for A-Fib?

Report by Steve S. Ryan, PhD Dr. Vivek Reddy of Mount Sinai School of Medicine, NY gave a presentation entitled “Renal Denervation for AF—Physiology, Mechanisms of Action and Rational in AF.”

RSDN Found Ineffective, Symplicity HTN-3 Trial

Background: (Before reading this report, it is recommended to first look at the our 2014 BAFS satellite presentation “Renal Denervation and Pulmonary Vein Isolation for PAF.)
Earlier in the Symposium, the results of the Medtronic Symplicity HTN-3 trial were announced and discussed. Medtronic’s renal denervation system was found to be basically no better than a sham procedure for reducing systolic blood pressure through six months.
Dr. Reddy described how previous surgical interventions (Thoracolumbar Surgical Sympathectomy—destroying some of the sympathetic nerve trunk) did reduce blood pressure by affecting the Sympathetic Nerves (Smithwick et al. JAMA 1953;152(16);1501-4). And the clinical trial Symplicity HTN-2 did work—84% of patients had a 10 mmHg or greater decrease in Systolic Blood Pressure (Esler et al. Lancet 2010;376(9756): 1903-9)
Then why was Symplicity HTN-3 a negative study? Was the catheter not properly employed? (Dr. Reddy described a new method of performing RSDN by using External Ultrasound Energy which has a minimal effect on the arterial wall.) Is refractory hypertension not primarily “sympathetically-driven?”

Does RSDN do anything?—Mechanistic Data

•  In a small study of patients with refractory high blood pressure (HBN) that couldn’t be lowered by drugs and other methods, RSDN did significantly lower high blood pressure (Brandt et al. JACC 59:901 [2012]).

•  In another study RSDN lowered blood pressure and Muscle Sympathetic Nerve Activity (MSNA) (Achlaich et al. NEJM 36:932-934 [2009])

•  In another study RSDN lowered renal hormones like Aldosterone, Metanephrine and Normetanephrine (Ahmed H/Neuzil P/Reddy VY: JACC-CV Interv 5:758-65 [2012])

•  RSDN improved heart rate variability (F. Himmel et al. J.Clin.HTN 14:654 [2012]}

Supporting Evidence for RSDN Helping A-Fib

•  Experimental studies of sheep show that high blood pressure (hypertension) produces fibrosis (interstitial collagen) and remodeling of the atria. (Heart Rhythm 2010;7:1282-1290)

•  In the ARIC study of nearly 15,000 people followed for 17 years, high blood pressure accounted for 20%-25% of all A-Fib cases (other factors were Obesity, Diabetes, Smoking and Prior Cardiac Disease). (Huxley et al Circulation 123:1501-1508 [2011])

•  Hypertension was the most significant predictor of recurrence after A-Fib ablation (Takigawa et al. JRAS, DOI: 10.1177/1470320312446212 [2012])

•  Sympathetic Nervous System overactivity predicted A-Fib recurrence (Arimoto et al. JCE [2011])

•  In Dr. Pokushalov’s work described under 2014 BAFS Satellite Presentations-Siberia, PVI with RSDN had much less recurrence than just a PVI (Pokushalov et al. JACC [2012])

But What About A-Fib Patients without High Blood Pressure—Would RSDN Help Them?

•  In a small experimental study using dogs, RSDN kept the dogs from going into A-Fib and reduced renal hormones (Q.Zhao et al. JICE [2012; DOI 10.1007/s10840-012-9717-y).

•  In another dog study, RSDN ameliorated pacing-induced changes in hormones and tissue structure (X.Wang et al. PloS ONE 8(5): e64611 [2013])

•  In a study of Obstructive Sleep Apnea in pigs, RSDN helped blood pressure and reduced A-Fib when the pigs had induced sleep apnea.(Linz et al. Hypertension 62:767 [2103])

Renal Sympathetic Denervation as Upstream Therapy in A-Fib?

Dr. Reddy described a multi-center randomized study of A-Fib and Hypertension. Patients with A-Fib and hypertension will have a catheter ablation procedure (PVI). Then some will be in the placebo group and others will have a RSDN procedure. Follow-up will measure A-Fib recurrence. (H Ahmed/MA Miller/VY Reddy, JCE 25:503-9 [2013]). The rational for this study is that Renal Denervation can dramatically affect sympathetic tone, is technically simple to do, and has minimal safety issues. In an earlier study, Renal Denervation significantly reduced blood pressure after three months (Ahmed H / Neuzil P / Reddy VY: JACC-CV Interv 5:758-65 [2012])

Dr. Reddy’s Final Thoughts

•  RSDN is a novel approach to modulate the sympathetic nervous system (one of several)

•  Many animal studies demonstrate the electrophysiological effects of RSDN

•  Potential Role for RSDN in A-Fib—Reduce A-Fib recurrence

Editor’s Comments:
In spite of the preliminary results of Symplicity HTN-3, Renal Denervation is not dead in the water. The full results of Symplicity HTN-3 haven’t been released and examined yet. And the new multi-center randomized study Dr. Reddy described may yet prove the effectiveness of RSDN.
Renal Denervation, in addition to helping people with high blood pressure and A-Fib, may benefit anybody with A-Fib. Because Renal Denervation is easy to do and relatively safe, RSDN may become another treatment option for A-Fib.

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Last updated: Wednesday, September 2, 2015 

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