A new robotic unit is gaining FDA approval:
Hansen Medical Announces First Patients Successfully Treated With New Flexible Catheter Vascular Robotic System
Key Milestone Toward Expected Commercial Launch in Mid-2011
MOUNTAIN VIEW, CA, Oct 04, 2010 (MARKETWIRE via COMTEX) -- Hansen Medical, Inc. (NASDAQ: HNSN), the global leader in flexible robotics, today announced the completion of its First in Man Study, during which 20 peripheral endovascular procedures were successfully performed with the Company's new flexible catheter vascular robotic system. The vascular robotic system features a flexible catheter with remotely steerable distal tips designed to simplify and enhance catheter navigation and therapeutic intervention. The study demonstrated the potential of the system to improve the ability of physicians to safely, effectively and efficiently treat vascular disease -- while exposing the patient, physician and hospital staff to less radiation.
My EP says the problem with robotic equipment is it has no "feel" to it. It just goes where its directed. He prefers to hand thread and manipulate the catheter because he can feel where it is in the heart; no punctures, less potential damage.
Remote Magnetic Navigation, employed by companies such as Stereotaxis, is an emerging technology in interventional cardiology. Catheters with magnetic tips can be steered within the patient, without the need for an electrophysiologist to maneuver the catheter or guidewire placement manually. Unlike other robotic navigation techniques, the catheter is controlled by steering the distal tip with a magnetic field, making perforations virtually impossible. The engineering was developed at the University of Virginia, and the patent rights were later acquired by Stereotaxis, Inc. to market and develop a magnetic navigation system, according to its 2005 10-K filing with the SEC. The technology has been proven to reduce physician and patient exposure to radiation and procedure times, as well as enable more precise navigation of the vasculature with increased safety and efficacy. Additionally, remote magnetic navigation increases catheter stability while reducing the temperature required to successfully perform an ablation.
As of January 2009, 18,000 total clinical cases were performed by magnetic navigation according to Stereotaxis's website, with a complication rate of less than 0.1%, representing a minute fraction of complications occurring with manual and other robotic navigation systems. The Niobe has yet to report an instance of perforation during a procedure.
And ablations are pretty effective now with 95% success rate in most cases (a-fib is a bit trickier). This new technology may be interesting but how much does it increase the cost? Ablations are not cheap now. Medical care is sky rocketing as it is.
Tuesday, February 02, 2010The Media, Robotics and Atrial Fibrillation Ablation
The NBC Today Show aired a segment on the Stereotaxis robotic system for performing catheter ablation of atrial fibrillation using magnetically-steered ablation catheters yesterday (video here). It sure generated a lot of buzz around our hospital. While I share the reporters enthusiasm for all the gadgets and gizmos (what doctor-engineer wouldn't like such neat toys?) the enthusiasm should be tempered with a strong dose of reality regarding this technology and any atrial fibrillation procedure.
First is the claim that the patient will be cured with "85-90%" certainty. While these success rates have been reported using this technology for the much simpler atrial flutter ablation, this level of success has not been substantiated in meta analyses of atrial fibrillation ablation studies to date:
The efficacy of AF ablation is largely influenced by a number of factors that include the following: operator experience, volume of ablations, type of cases ablated, to name a few. Nonrandomized trials document a wide variance in the efficacy of AF ablation. In the setting of paroxysmal AF, the efficacy of a single procedure ranges from 38% to 78%, with most series reporting an efficacy of 60% or more. The efficacy reported in persistent AF ranges from 22% to 45%, with most centers reporting an efficacy of 30% or less.
Certainly, patients with intermittent atrial fibrillation typically do better than those with chronic atrial fibrillation, but we are not privy to the number of procedures a patient has to undergo to achieve the success rate suggested by the physician operator in this news segment.
It is also interesting that we learn little of the limitations of robotic navigation using magnets previously reported in the literature:
Using the coordinate approach, the target location was reached in only 60% of the sites, whereas by using the wand approach 100% of the sites could be reached. After step 2 ablation, only 1 PV in 4 patients (8%) could be electrically isolated. Charring on the ablation catheter tip was seen in 15 (33%) of the cases. In 23 patients, all PVs were isolated with the conventional thermocool catheter, and in 22 patients only the right PVs were isolated with the conventional catheter. After a mean follow-up period of 11 ± 2 months, recurrence was seen in 5 patients (22%) with complete PVAI and in 20 patients (90%) with incomplete PVAI.
Admittedly, the data regarding char formation on the ablation catheter were presented before the approval of irrigated-tip ablation catheters less prone to coagulum formation that are used more recently, but few data have been published. But we recall that the reporter makes a huge claim that moving the catheter with the magnets is more "precise," using the analogy that "it's like trying to write on a piece of paper with a pencil using the eraser..." The above data dispute these accuracy claims. Further, she conveniently ignores the errors in catheter placement inherent to the patient's respiration or from the movement of the heart itself. Also, we hear little of the additional time involved in moving a catheter with a magnet versus the hand.
While robotics might help the operator's back and help reduce radiation exposure during the procedure, I am aware of no data that supports the superiority of robotics to achieve success with better safety or accuracy with atrial fibrillation ablation over more conventional manual approaches. Further, long-term data regarding success rates of this technology for catheter ablation in atrial fibrillation have yet to appear to any large extent in peer-reviewed journals.
Disclaimer: I have no industry ties with Stereotaxis or other robotic atrial fibrillation ablation systems.
I think this Dr. disagreeswith 95% ..not sure where all these %'s are coming from. I think Dr.s might be giggling at them.
Nice blog comments afterwards.
Why is healthcare so expensive in the US?
I had the EP study and ablation and the private price tag was 9000€. I only had to pay 27€ of that cost.
Perhaps because it's not underwritten by the government. The current administration is trying hard to change that though whether the public like it or not. With insurance, my EP procedure will personally cost me (US) $100. I currently pay $44 per week for medical insurance for my spouse and myself with the rest (the lion's share) covered by my employer.
We don't pay anything here, unless you want a private room or something extra like that. But, the result is incredibly long waiting lists, I waited 18 months for my ablation. If there are emergencies, you get in right away, which bumps everyone else down the list again. Our health care is excellent though, our equipment is great, and we have top notch doctors. My EP doctor has written several papers for international medical journals on arrhythmias and ablations.
So it's free, but you have to be patient if your condition is not life threatening... They found a tumor in my husbands intestine, and he was in for further testing that week, and surgery the following week. He was in hospital for 10 days, and again at no cost to us.
Oh, and on the latest and greatest equipment, I'd rather have the greatest doctor, hands down, any day!! :)
Are you in the UK?
I am originally from Sheffield, but moved out here to Finland.
I waited 5 weeks from diagnosis to get an ablation. I am glad it wasn't longer or I would have chickened out!
Why does medicine cost so much in the USA? I'd say because it is the best. And fastest.
My wife went to the emergency room about a month ago because of stomach pain, the ER doctor found a possible cancer in the female organs. See was able to get all the tests, and see three different doctors, including specialist in the next two days. She had a planned week of vacation and took it, and when she came back from vacation she had an appointment the next day with a Gynecologic Oncologist surgeon and had surgery the following Monday. The prognosis is all the cancer was removed.
Now this is medical care USA wise, I don't look forward for any imporvement with the mess coming out of Washington DC.
P.S. We've had medical insurance most of our adult lives, and now have Medicare plus private insurance. This means we'll see very small bills for all the work that was done, GO USA!
US cost is 10 times that gross cost, but discounts take about 40% off.
I could give the same comment about Finland being the best too. I was surprised that I got the ablation that quickly. It only took time as the EP/ cardiologist only comes to the hospital that I was treated in once every 2nd month.
We have only a handfull of cardiologists that specialise in EP studies and ablations. I was very grateful that he took me straight away. I have no medical insurance at all.
I know what you mean; I couldn't have asked for better insurance coverage when I went in for my ablation; had they made me wait for months for referrals and red tape, I would have died, at that time we paid $830 monthly for a family of 4 (group coverage).
I stayed 4 days which included the RF ablation, testing daily, cardiac MRI, genetic testing, CT's, Xrays, cardiac catherization, pacemaker/icd implant my hospital bill was $275,000 just for those 4 days - I paid $338.00 - because I had met my $3,000 deductible for the year with previous testing & doctor's visits. My ICD device alone was something like $125,000.
Now the downside - because my medical costs were almost $500,000 for the year, they uprated our policy 33% for the next year and put a rider on my health plan for the amount of coverage yearly even though I had only 1 previous surgery (female) in over 20 years, and no other major health problems.
The Stereotaxis system is supposed to be a great system for patients who have difficult cases and need ablation at the RV apex; this was in another thread recently about RV Apex ablations or something similiar - there's a few links and info to it, but I can't remember off the top of my head.
AF ablation is a big deal. It is not for the faint of heart.
The doctors issues...
The procedure is hard to do. AF ablators know AF diminishes quality of life, but we also know the delicate balance of performing a life-enhancing procedure that has potential catastrophic complications. This tightrope makes me nervous. No other procedure induces a fraction of the mental worry of an AF ablation.
The procedure requires standing with a lead apron and focusing for three hours. An AF ablation is hard on the doctor (human). Not complaining, just stating the facts. It limits what else you can do in a day. In the past, AF ablations were once per week. As ablation technology advances along with our skills, the temptation to help more patients has been hard for me to control.
In private practice EP, most can only ablate two full days per week. There are office patients to see, non-reimbursed patient phone calls to make and the mundane cardiac devices to implant. Reality.
Stop whining and just refer these extras to other ablators, one might suggest.
I am glad you pointed this out.
You see, AF ablation is technically demanding, physically exhausting, potentially dangerous, and takes years to get good at. Also, it is compensated at the same rate as an ablation that takes 45 minutes. It is not hard to imagine that there are only a few of us doctors who do this. In my city of a million people, there are really only two other electrophysiologists who do this procedure enough to have sufficient skills. Sadly, there are many "dabblers" in AF ablation, which of course, means their are patients of "dabblers." There are few other doctors to refer to. Reality, again.
Conclusions and Wishes…
We ablators are human. In our present paradigm, it is impossible to ablate all potentially curable AF. For every forty-something intermittent fibrillator with a normal heart, there are four older patients, with thighs as big as a waist, diabetes and sleep apnea. They have symptoms too, and look at you like they know you might be able fix them. But, we are only human, and right now, despite the desire to do so, we cannot ablate every AF patient. Those patients in the grey of decision making are subjected to the rationing of realism.
A perfect world of AF care would entail many differences. Just one fantasy, would be to have helpers in the EP lab. I could train non-doctors to put sheaths in and handle catheters. It is just a physical learnable skill. That would help. But this could never happen in our present legal climate. Forget it. Especially in a state like KY, where I can't tell you how many times I have heard nurse administrators speak the words, "that's not in a nurses' scope of practice."
Another societal solution would entail having more doctors to do procedures like AF ablation. That should be easy. EP training took only eleven years and 110,000 dollars after college. Then, as an experienced specialist, it took me four or five years to get really comfortable with the procedure.
This is a tug-of-war. Modern medicine advances. We can now successfully treat historically incurable diseases. But to do so requires much from the doctor and from technology. AF ablation may only be a metaphor for an upcoming paradox in medical therapeutics: treatments may exist, but they will necessarily be rationed because of the scarcity of human-power to perform them.
Dr.s blog comment good also
I live in Canada, and really I have no complaints about the quality of care here, it is fantastic. I didn't mind the wait, as I was not ready at first. I had to have that time to have a few more attacks, and be fed up enough to get it done!!!
I have spoken to many people in the US who can't even go to a doctor because they have no coverage, they are very frightened, but simply can't afford to get tests or procedures done. I lived in the States with my family as a child, but my Dad had a heart attack, so we had to come back to Canada because we could not afford his care there. We would have loved to stay though. I love it there and I love it here!
They never make you wait here if it is urgent or if you are in a lot of pain...but the wait times are out of control for sure! No one pays though, so even if you have no job, no coverage, you get the same care as the CEO of a big company!! Your system sounds fabulous!! I think as society ages, we will all feel the shortage of doctors and health care...
I think if I ever would lean toward Ablation I would go the Stereotaxis system for my SVT's.
A-fib get a hand held doc that didn't have issue's with drugs, alcohol, or tennis elbow :)
I have to admit, when folks outside the US criticize our health care system it comes across as being very smug to me.
Take the UK for example, here's a video of a UK "nurse" causing massive brain damage when she switches off a life support machine by accident then has no idea how to turn it back on.
Let's not hold up NHS as a model practice, OK?
As for Canada, they have to make $0 investment in innovation, technology development, or best practice development. They get it all from the US, for free. And I still see folks from Canada with more complex cases get sent down to US facilities for care which Canada will pay for. So what's that tell ya?
And for those that think people in the US are turned away for health care, are you nuts? Any medical facility that would turn away someone based on financial circumstances would get their pants sued off. It would be all over the tabloids, oops I mean fox news. :-) I see people present all this anecdotal evidence for what's wrong with US health care, none of which is based on facts. Heck our free clinics probably exceed quality standards of most other hospitals outside the US.
just my $0.02. Which won't even buy you a bandaide today. :-)
Anybody on this forum uninsured and had Ablation in the USA via charity?
Me me me, damn I don't live in the US!!!
(just kidding/don't sue me)
Free is a "Nuts idea", nothing is free, including medical care in Canada and Europe, for examples. The question is which system is the best value. Most people in the USA do not support government run health care. This includes many young people who do not have private heath insurance. They should I would agree, but in the USA we still have rights AND responsibilities.
The treat of implementation of government run health care in the USA is forcing increases in the cost of coverage for us all, including those with coverage. The company from which I retired after 35 years of service provides health care coverage to me, including a prescription medication plan that is much better than any of the current (Passed during the Bush administration) government offers. But, the government take over is causing my company to make public statements that the changes they are seeing in terms of tax exempt expenses is making them consider dropping prescription coverage for retired employees, me! One of the many benefits yet to be seen by government takeover. I am sure it will only get worse, as is the case in Europe and Canada... notice any riots lately?
Ever hear of Medicaid?
I lived through my father needing a heart transplant, losing his job, losing his insurance. We were faced with losing our house. We reached out and got the help we needed.
Ablation is not a first line treatment on Medicaid.
Go to a doc w/ your medical card and ask for Ablation right out... you will be turned away and turned toward drug therapy.
Canadian electrical engineer John Hopps invented the world's first cardiac pacemaker in 1950. Just saying! lol. There are many, many great medical advancements from both Canada and the US. I don't think this is "my country is better than yours" issue. I think everyone deserves and should have access to health care, no matter where you are from or how much money you have. Canada and the US pour millions into research every year. There are many great advancements from both countries, and I am sure from Europe as well. The French, for instance, are responsible for indentifying the HIV virus and a test for it back in it's infancy. I think all health care systems have failings, all of them. But, to say that one country contributes $0 is unfounded and insulting. Our system has many failings, absolutely, and there is not doubt there are procedures done in the States that we can't get here, that is why we are neighbors, and friends:)