Physician Testimonials
Dr. med Sabine Fredersdorf
University Clinic
Regensburg, Germany
CMC Date: Aug 30, 2007
Interview Date: Feb 12, 2008
Ablation for the treatment of atrial fibrillation (AF) is a promising new therapy with several known drawbacks. For interventional electrophysiologist Dr. Sabine Fredersdorf of the University Clinic at Regensburg, Germany, one of those drawbacks was the inordinate amount of time it took to safely and effectively perform a pulmonary vein (PV) ablation of atrial fibrillation.
“Ablation of atrial fibrillation is one of the most time-consuming procedures in interventional cardiology,” Fredersdorf stated. Her concern was not mere clock watching. “Increased procedure time is associated with a higher rate of complications,” she explained. “At our clinic, we were looking for a way to reduce the procedure time mainly as a way to reduce the complication rate.”
The University Clinic at Regensburg is a busy electrophysiology clinic but one that does not have a waiting list for AF ablation. The clinic used to ablate about two patients a week, although that schedule was variable. However, AF ablation was not only a difficult and time-consuming procedure, it had its share of complications.
With a wide variety of options for catheters and ablation techniques, Fredersdorf and colleagues used mainly cyroablation for AF until switching to the Pulmonary Vein Ablation Catheter (PVAC™) from Ablation Frontiers in October 2007. Fredersdorf learned about this innovative technique from a colleague experienced in the technique. 
The PVAC catheter is a novel decapolar ablation catheter that is used with the GENius™ multi-channel, duty cycled RF generator. The system does not require three-dimensional imaging or robotic steering.
Dr. Fredersdorf then attended a Clinical Mentoring Course or CMC program which allowed her to observe ablation using the novel system and practice it in a controlled environment. “The CMC created a very safe learning environment,” she said. “The CMC is a good way to see it. It’s important to see the technique done by someone else before attempting it.”
The first thing Dr. Fredersdorf noticed was that the PVAC system reduced procedure time by more than half. She estimated that skin-to-skin procedure times using the cryoablation method ran about three hours, but the PVAC catheter reduced that to about one hour and 20 minutes. While this has the obvious benefit of increasing patient throughput, Fredersdorf was pleased to see that it has also reduced complication rates.
“We’ve only done 16 cases to date,” she stated, “but we have had zero complications.” In a series of her first nine AF procedures using the PVAC catheter system, she found that she could isolate 97% of all four pulmonary veins with no procedural complications with an average procedure time of only 84 ± 5 minutes.
While Dr. Fredersdorf finds it is really premature to discuss cost effectiveness of the system, she has already made some observations. “It can be done in a shorter period of time, using less equipment. That will affect cost effectiveness. But for us, it is still too early to tell.”
The first group of patients who were ablated with PVAC at the Regensburg clinic are just starting to come back for their first follow-up visit, scheduled for three months following the ablation. Dr. Fredersdorf will review ECGs from these patients, typically obtained from ambulatory monitoring. Patients who show no evidence of AF may be allowed to discontinue antiarrhythmic agents.
Her biggest reservation about this innovative new system is the lack of long-term data. “I am curious about these patients,” she admitted. “I want to see how they are doing, how effective the ablation was.”
As an electrophysiologist, Dr. Fredersdorf has had the opportunity to work with many novel products, catheters, imaging systems, and devices.
“PVAC is fast and easy,” she said. “Cryoablation is more complicated, and it was always difficult to check to see if the ablation was successful. And, of course, the PVAC is quicker.”
Her frontline approach for AF ablation is now the PVAC and GENius generator. It has reduced complications, streamlined the ablation, and cut procedure times in half. While the real bottom line for Dr. Fredersdorf is the dramatic reduction in procedural complications, she also admits that the novel system has drastically simplified clinical requirements for successful AF ablation.
“We don’t need to do 3D imaging. We don’t need robotic steering. There’s simply no need for it.”
Dr. Stephen Murray
James Cook University Hospital
Middlesbrough, UK
CMC Date: Oct 10, 2007
Interview Date: Jan 31, 2008
About 700,000 people in the United Kingdom have some form of cardiac arrhythmia. Atrial fibrillation, a common arrhythmia particularly in older people, consumes about one percent of the National Health Services (NHS) budget, despite the fact that curative approaches are available. With electrophysiologists in relatively short supply and an imperfect chain of referral, Dr. Stephen Murray at the James Cook University Hospital in Middlesborough, England, has come to appreciate first-hand the role of advanced technology in helping manage the growing problem of cardiac arrhythmias, particularly atrial fibrillation.
Dr Murray carries out over 250 ablations per year, of which around 80 are AF ablations. Prior to October 2007, his redo rate for AF patients was approximately 30% with a complication rate of almost 7%. In his standard approach, a double transseptal puncture was used to access the left atrium and then a common lasso-type catheter was combined with an advanced three-dimensional imaging system (NavX) to perform the ablation. “The double transseptal with lasso and NavX was my preferred approach,” he recollected. “PAF patients underwent PVI using wide area ablation, and I routinely put in a roof line. Chronic cases (which only accounted for 20% of the cases) had the same plus CFAE ablation.”
The time and cost required for this approach made him eager to look at new technologies. “My average patient is 60 to 70 years old,” he reported. Procedures could be tedious and time consuming. In fact, the facility never did more than two AF ablations per day, because the cases were so unpredictable. With a growing waiting list and procedures that could sometimes seem open-ended in terms of time requirement, he was very open to ideas to streamline things.
When seeing patients in clinic, they were many who could in theory be eligible for the procedure, but the constraints on procedure time, complications in the over-65 population, and redo rates were a major concern. Nevertheless, patients were listed for the procedure.
Around October 2007, Dr. Murray met with Ablation Frontiers to discuss an innovative new set of ablation catheter and multi-channel, duty cycled RF generator. While attending a clinical mentoring case (CMC), he saw the devices in action. The CMC is a novel approach to physician training that allows a physician to work side-by-side on a procedure with another physician who is familiar with the devices.
“It’s nice to chat with someone who’s done more of these cases than you,” Dr. Murray recounted of his experience at CMC. Even more beneficial was the ability to see the products in action rather than just study them. “Some of the tips and tricks with the catheter handling are hard to explain, but when you see someone else doing them, it helps you to understand how to get the best from the system.” The CMC is a one-day intensive program involving didactic sessions and case observations.
By November, Dr. Murray had imported this new technology into his clinic, which required some adjustments to his technique but not a steep learning curve, particularly when one is already comfortable with LACA. With other catheters, the device was inserted into the body, maneuvered to the heart, and only when the catheter tip was inside the heart did the physician really need to focus on moving it precisely. The Ablation Frontier system was different.
“It’s a slightly different approach,” Dr. Murray stated. “It was a novel experience. It’s not so much the learning curve, it’s a case of slowing down a little bit. A lot of the preparation takes place outside the patient, as the PVAC takes a bit more care and attention with its handling, including the loading of the wire. But it’s really straightforward.”
Once the catheter was inside the heart, Dr. Murray found that the device operated quite differently from what he had been trained with. “It was a paradigm shift,” he commented. “You can push it hard against the wall of the vessel, which is a complete contradiction to what you’ve been trained to do. But the catheter has got to be pretty safe.” The design of the catheter makes it such that this kind of pressure is completely safe, even appropriate. A perforation is virtually impossible with the catheter design.
While the catheter required somewhat of a novel approach for a person trained with conventional 
catheters, the multi-channel, duty cycled RF generator was also a paradigm shift.
“The power from the generator takes a bit to get used to,” Dr. Murray recalled. The duty cycled RF generator uses much less energy than comparable systems."When ablating at 4-10 watts I found myself wondering, ‘is it really working?’ but I could see that e-grams were ablating and that the rythym was organizing.”
The unique catheter shape and generator design makes uniform circumlinear lesions with much less energy and more efficiency than prior systems.
“We have not had a case where we could not achieve the outcome, complete PV isolation (which we defined bidirectional block across the vein).” Dr. Murray said,”We now have early data on over 30 patients, and I’m pleased to report zero complications, and a success rate of >80%, although it’s obviously early days with regard to follow up.”
The acute success of the Ablation Frontiers system has caused Dr. Murray to change the way he is handling atrial fibrillation ablations at his institution. Procedure times, which used to be regarded as more or less open-ended, have not only dropped sharply but have approached predictability.
“Skin-to-skin is about 90 minutes,” Dr. Murray commented, “And we are consistently spending less than 60 minutes in the LA. We used to routinely do two patients at week, and sometimes we’d cut that down to one because it might be a re-do with an atypical peri-mitral flutter. Now for paroxysmal atrial fibrillation, it’s three in a day and we’re finishing earlier.”
When the Ablation Frontiers system was first introduced to the clinic, Dr. Murray enthusiastically scheduled three cases a week. “We started with three on, once a week. It’s been really easy. It’s possible to schedule now. We could do four cases a day. It would have been foolhardy to attempt that previously.”
In fact, atrial fibrillation ablation scheduling represented a problem both to patients and the clinic.
“We’ve done about four months’ work in the last 12 weeks,” Dr. Murray reported. “We’re ahead of schedule by a month and a half. The procedures are less sapping, meaning that it’s now feasible to plan 2 days of AF work, each with 3 cases – something we’ve recently been doing”
The transition from two cases of indeterminate length a week to six cases of predictable length a week has increased patient throughput. The best result is that patients on the waiting list are moving up more rapidly in line, without placing undue burden on the limited resources of the clinic.
Cost concerns affect healthcare providers around the world.
“For a PVI, this method really is cheaper and fast. I can’t give precise figures, but we are probably saving about £2,000 a case,” he estimated. “I guess you could also say we save money by throughput, but that’s harder to demonstrate in this health care system.”
While it appears that the new Ablation Frontier system will benefit the clinic for a certain type of case, Dr. Murray has pondered whether this system can apply to challenging cases as well. He has already used the system on a case he knew would be particularly difficult. “I was in the left atrium about an hour,” he remarked about this particularly challenging procedure. “And that’s as hard as it gets.”
While he is quick to state that point-to-point atrial fibrillation ablations cannot truly be classified as “difficult,” he remembers them as laborious interventions. “They are slow and you have to keep one eye on the blood pressure and one eye on the e-gram the whole time.”
While Dr. Murray is intrigued by new innovations in robotics, he does not see any need for robotic or magnetic steering approaches for such cases. “I like the look of the robotic steering system, and I might incorporate those tools for some cases, but not for a straightforward PVI.”
Dr. Murray had been using NavX for atrial fibrillation ablations as recently as last fall.
“We’ve stopped using it for PAF cases,” he said describing imaging for his PVI patients. “We don’t need it. For some chronic, persistent cases, it might be useful perhaps. So there might be an area where it would still be useful.”
Dr. Murray used to view atrial fibrillation patients with a certain degree of trepidation, because some cases were notoriously difficult to treat. When patients had to return to the clinic with atrial fibrillation post-procedure, it created a great deal of frustration for him and stress for the entire clinical team. The new system from Ablation Frontiers has changed all that. “It’s saved me a lot of headaches,” he said.
“I’ve started enjoying PVIs again. I can offer this procedure now with a degree of confidence that it’s a relatively low-risk intervention that won’t cause problems.”
Physician Testimonial
Dr. Marcus Wieczorek
Heart Center Duisburg, Center for Electrophysiology, Duisburg, Germany
CMC: February 20th, 2008
Interview: August 18th, 2008
The Heart Center in Duisburg, Germany
first began performing atrial fibrillation
(AF) ablations around the year 2000. At
that time, Dr. Marcus Wieczorek was
enthusiastic about the potential of AF
ablation, but he had to rely on the technology
of the time, which included a
lasso catheter and external imaging
technology. He recollected those early
efforts using four conventional-type
catheters in the pulmonary veins (PVs)
and looking for ectopy, which was then
treated within the veins.
“Step by step, we changed our methods.”
Dr. Wieczorek and the electrophysiology
(EP) team at Duisburg, like many other EP
groups around the world, avidly followed
the efforts of Dr. Michel Haissaguerre and
colleagues. Publications from this team in
Bordeaux, France encouraged him about
the theoretical promise of catheter AF
ablation, but the practical reality at that
time was that the procedure was long,
arduous, and prone to complications.
In fact, the Duisburg team found themselves
taking an increasingly conservative
approach to AF ablation because of the
high incidence of complications subsequently
reported by other groups. Eventually they
moved to a substrate modifi cation strategy
to
reduce the chances of delivering RF in
the pulmonary veins. “At that time, we were using three-dimensional (3D) imaging
systems and a procedure took a very long
time, four to six hours was typical. We only
performed about 20 or 25 procedures a
year.” The procedure then deemed too
risky for many AF patients.
A drastic change in approach and mindset
occurred when a representative introduced
the EP lab at Duisburg to a new technological
solution offered by Ablation Frontiers. Dr.
Wieczorek quickly availed himself of
Ablation Frontiers training by observing
procedures performed by colleagues who
were already using the technology effectively
in the Netherlands and Switzerland. “We have completely switched our attitude
about AF ablation since Ablation
Frontiers,” Dr. Wieczorek reported. “We
are increasing the number of procedures we are performing at the moment and expect to do
even more in the future.”
The training took place at centers routinely using and
well versed with Ablation Frontiers technology. Dr.
Wieczorek found the training not only instructive, but
quite useful in terms of how Ablation Frontiers products
would be deployed. “Different labs use different
strategies,” he reported. “It was good to see this in
action. It was very positive, because all of the colleagues
were quite open to discussion.”
To date, the Heart Center in Duisburg has performed
about 40 AF ablations using Ablation Frontiers’ innovative
technology, and there have been no procedurerelated
complications. Currently, only patients with
paroxysmal AF are being ablated, but Dr. Wieczorek
will soon extend this procedure to patients with more
severe forms of the arrhythmia, persistent or permanent
AF.
In Germany, a general cardiologist serves as an intermediary
and must grant the EP lab permission to conduct
subsequent checks on the patient. As a result,
many AF ablation patients from Duisburg are implanted
with a loop recorder in order to gather data on arrhythmia
burden both before and after the ablation. “At three months, our success rate is around 85%,”
Dr. Wieczorek reported. Data come mainly from loop
recorders with some patients monitored using sevenday
Holter monitor instead. The arrhythmia burden is
assessed by adding together the durations of any
episodes of atrial tachyarrhythmias, with a treatment
failure counted as having occurred if a patient experiences 
more than combined 30 seconds of atrial tachyarrhythmias.
Even by this strict defi nition, success rates are high
and complication rates are very low.
“We have observed no complications to date,” Dr.
Wieczorek stated. In the past, one particularly worrisome
complication was perforation, which Dr.
Wieczorek says has not occurred with the Ablation
Frontiers system.
Furthermore, the Heart Center in Duisburg no longer
uses 3D mapping routinely for AF ablations, although
Dr. Wieczorek said it was still useful in cases of recurrent
AF despite PV isolation, where the source of the
AF may be outside the pulmonary veins, and he might
employ a substrate modification strategy.
“In my opinion, the equipment from Ablation Frontiers
is easy to handle,” Dr. Wieczorek commented, and the
learning curve was short. “It’s not as tough as learning
the more complex AF ablation procedures, which are
more difficult with respect to left atrial geometry.
Getting good left atrial contact is tough with other
systems.”
“We are increasing the
number of procedures we are
performing at the moment
and expect to do even more
in the future.”
Clinicians can become quite familiar and comfortable
using the Ablation Frontiers system in just a few procedures. “The Ablation Frontiers products make AF ablation
quite cost effective, which is why we are able to offer
it to so many of our patients,” Dr. Wieczorek added.
The older approach required not only external mapping
equipment but additional diagnostic and mapping
catheters for each procedure. “Plus it is expensive to
use a cath lab for six hours for one procedure.”
Dr. Wieczorek recounted the last patient on whom he
performed an AF ablation. “We used two catheters –
PVAC and a coronary sinus reference – and got complete
pulmonary vein isolation. The catheters worked
very well, and it was not a difficult procedure. We
achieved perfect results.”
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