where is the line for informed consent? (new catheters, etc)

Before any serious medical procedure (cardioversion, ablation, etc), there is the concept of informed consent, where the MD will give the patient a form to sign acknowledging their permission to perform said procedure.

But it seems that (in the EP world) there is a great deal of ongoing research/studies, and that perhaps the line for informed consent may not be as clear. The studies published by EP's where they experiment with things such as:

Scenario 1) comparing newer style catheters vs older style catheters
Scenario 2) the tradeoff between longer (vs shorter) ACTs (Activated Clotting Times)

are done on real patients (not just simulations). And in many studies, they're not just expecting "time of surgery" (or other relatively minor) things to vary, they're also expecting differences in some major life-changing items:

Scenario 1) outcome measured: incidents of intracranial thrombotic events
Scenario 2) outcome measured: thrombolic event rate vs rate of bleeding complications

Is there any notion of "informed consent" made for these experiments? For example, before Dr. Natale does an ablation, does he (or his staff) say that he is going to be using a newer catheter (Biosense, or whomever) and explain the pros/cons of this? If so, do people often decline ("I'd rather stick with the known tools, rather than risk a potential worse (or better) outcome?" ).

Dr. Natale is by all accounts the best at what he does, but... searching on his name in PubMed yields a huge number of papers (367). Granted, he is not the main author on all of these, but it does seem that he does a fair amount of experimentation. I'm just trying to get a feel for how this is handled in the real world. Clearly some experiments are safer than others. Do they offer the patient a range of choices ("We have study A, where the expected upside is not significantly better, but the expected downside is also not that bad. And we have study B, where the expected upside is an amazingly good outcome, but the expected downside could potentially be pretty bad. For your ablation, we'd like you to in study A or study B. Let us know your choice." )?

Thanks in advance for any anecdotal (sorry, couldn't resist) or other insights.

Cheers,
-Ted

Hi
I am not sure that is is often as cut and dries as you example. I am part of a pilot targeting GP's and I did have a choice and I think most of the ins and outs were clearly explained. The consent forms have been through an external ethics committee. However there is a level of detail and nuance that I am not able to grasp: I am not an EP. For me there is an element of faith in my EP here. I spent some time looking at my options but having decided who to entrust I try to step back and go with what they suggest.
Les

" I spent some time looking at my options but having decided who to entrust I try to step back and go with what they suggest. "

I concur with Les, your job is to pick the right EP and then trust him to do his job.

If you have a question about the equipment discuss it with EP, but don't expect to tell him what to use.

Natale's group will have you sign a consent form for anything that might be deemed experimental in nature with potential for any downside adverse effect. And in this field your very best bet is partnering with a guy like him.

He will tell different patients different things based on what he feels is their individual risk/benefit of participating in any given trial. The vast majority of which do not have any significant downside potential, but some that do are clearly noted as so, and if Dr N feels you should not participate in such a trial, he will not hesitate to tell you so and recommend you not sign up for it, even when the leader of the trial may be recruiting new ablation patients prior to their procedure to join that research ,,, assuming Dr Natale approves in their case.

On the flip side, going to a lower level EP who only does the most basic PVI only ablation as its the only one generally recognized( Im using that as an analogy not a real example) then you have hamstrung yourself from the get go to getting at best an ablation that works but only if you have a very easy case and your EP does a near perfect PVI.

With the elite level pioneers, especially with those having more challenging cases which yours looks increasingly like it might belong too Ted, you stand a far greater chance of them having the best tools and best experience in address successfully just what your heart needs in the fewest possible among of total ablation burden you heart can become stable by doing.

Shannon

Thanks for the replies.

Let's talk about a specific example.
And for sake of simplification, let's say we're talking about Dr. Natale.

Example: Let's say Dr. Natale uses version 2.2 of EAM electro-anatomical mapping sw.
Now version 3.0 comes out. Someone has to be the very first patient... for Natale to use version 3.0 on.
(Yes, the EAM sw has been through internal testing by the manufacturer, but we all know sw testing is imperfect).

Is this the sort of thing where he would inform the patient?
Or would Natale avoid the possible risk by waiting until 3.01 comes out? (Let others find the bugs first)?
(The cynical person might ask if the first patient to use 3.0 gets a discount)

The same question could be asked of a catheter model upgrade. Natale is the rock star in the EP field, so all the hw manufacturers want to have his feedback on their latest catheter changes. On the other hand, some human is going to have to be the first person that he uses it on. Does that rise to the level where an explicit consent is needed, aside from the generic "you have my permission to do an ablation"?

These are the sorts of changes where it "seems safe", and usually is. Until it isn't.
There are numerous stories about unexpected bugs/glitches with hw/sw upgrades.

If this were (say) spine surgery, I wouldn't be as concerned about hw/sw changes, because... even with laproscopic spine surgery, the surgeon can still see (directly visualize) what is going on, and what his tools are doing. In contrast, with an ablation there is no direct visualization - it's all interpreted through a layer of sw (EAM mapping), or through very indirect imaging (fluroscopy), or through physical feel. All of which pale in comparison to seeing what's actually going on.

Natale's name is on a ton of papers, so it appears he is constantly trying new hw/sw/processes/tools. I'm just trying to get a better handle on what level of changes he deems to rise to the level where he offers patients a choice (or asks for explicit consent). Because on the one hand, it's great to be in the hands of the best EP. On the other hand, if the best EP stays at the front of the field by constantly improving via in vivo experiments with new hw/sw/concepts/tools, that may not be the EP that I want working on my heart. Perhaps I might be more at ease with EP #2 (#2 in the world), who uses slightly more "boring" hw/sw/tools, but has the safety factor of not living on the cutting edge.

-Ted

Natales group is the largest research center in the world and thus his name is on a huge amount of research as a result. The makers of software including those who research it on the front lines put the software for mapping though extensive paces in animals and in simulations long long before the first person is ever used. They also cross check it all with Fluoroscopy in real time as they go, and Natale can do a perfectly respectable ablation with Fluoro alone even if the whole Carto 3D system should crash, so you have very little to worry about..

You can find a million and one possible gotchas to walking out the front door each day as well. I understand wanting to be cautious which is all well and good, but if you second guess every single movement of a elite level operator in nay such field, your are going to drive your self bonkers and might well scare your self out of getting an ablation you might really could use, for little real world risk to begin with.

Just saying, be a little careful about trying to hard to imagine every possible bad outcome under the sun and assume guys Like Natale haven't thought of them accounted fr them long before and done their best in your and their behalf to minimize those risks to every degree that is possible at any given point in time.

A person could wait until it all evolves to the point where these procedures are almost risk free .. but by then you may have lived a whole life time or three of steadily progressive AFIB with such advanced scarring that while low risk, it might be much lower odds of success as well ... by way of analogy and example.

As George noted, its usually far better to fully vet the EP and chose the best one you can based on the whole collection of evidence while knowing the even the best are not perfect creatures, and then go forth with confidence that you could not have possibly made a better choice for yourself, up front and before hand, than you did. How can you possible do better than that??

That will bring you great peace of mind and help avoid the easy trap of what is often called mind-twisting of oneself beyond their own best self interest.

Any one of us is unlikely to bring the same level of nuanced understanding and care to the table that a guy with the experience of Natale does to each of these tools and procedures docs of that stature tend to share.

so, in my view it is far better to trust them enough and in line with their skill and experience level, than for a lay person like us getting either overly enamored by or freaked out by, any one of these new tools or whiz bang systems.

Why not just trust the most experienced and successful people at this craft in the world that they know enough about what they are doing that it really isn't in our own best interest to overly second guess what they plan on using in our case, and thus making our demand that such a maestro use something else based on our relatively minuscule level of understanding of same. It's all fine to learn about all this and I enjoy it very much too, but I long ago learned that I can safely trust Dr N's instincts even though I know he is not infallible, I also know there is no one else in the world whose hands I would rather entrust my heart when it counts than him, up front. And you can plug any any other elite specialties leaders name in when concerning most cases for other challenging procedures as well.

Shannon



Edited 1 time(s). Last edit at 07/30/2015 10:23PM by Shannon.

+ 1 to what Shannon has said. You need to have faith in your practitioner, if you do not have this it might be better to not go forward with any treatment. Or chose a practitioner that only uses the most tried and tested methods. Personally I did not like the outcomes these options offered in my case (severely enlarged atria). When offered the chance to be part of a pilot I did ask questions (e.g. will this increase my radiation exposure- it did not) . However I also had to accept some uncertainty will this method (GP ablation) offer a higher rate of success...probably but since I am part of the trial the statistics to support this are not yet robust. There are no indications that outcomes are any worse then they would have been and some signs that they might be much better. The largest 'cost' from my point of view is that I spent an extra (not charged) day having detailed pictures taken of my sympathetic nervous system, the time was largely because they were doing the pictures twice to make sure they were consistent.

Plus Ted, your last proposition that you might be better off with a somewhat lessor but more boring EP who is not driving advances in this field is answered in favor of the top dog by the very low rates of serious complications in spite of the degree of highly challenging case load Dr Natale addresses every week. Working in such cases a less experienced EP is sure to find him or herself over their head more often than they would like and risk not only poorer outcomes but more frequent complications as well. And yet, Just from our own very impressive real world anecdotal reports of so many consecutive patients from Natale with nothing more than the usual garden variety post ablation temporary issues, is very powerful evidence of his excellent margin of safety over the course of do really tough cases he is asked to handle from
all over the country.

And it's not at all that Dr Natale uses a new toy on every other patient.. All the tools he tests have been through thorough safety vetting and he told me he only selects the very most promising tools to explore in depth. He is very technologically astute ... one of his pet interests are theses technological innovations ... and he is often asked for his feedback in the design phase of these tools by the various manufacturers.

But more than that, I can't count the number of cases Ive been a party in at lest as a bystander and including instances like in my Lariat leak and subsequent stoke where having his keen judgement and experience literally saved mine and other folks bacon.

For example, immediately after my stroke last May 10, 2014 I called Dr N from the small ER near Sedona. He was on a flight back to Austin from San Fran but called me back as soon as he landed and when I told him what happened he urged me to fly to Austin the next day.. And immediately he put me on Eliqius and had my wife and I stop at the nearest Walgreens on the way home from the ER where they only gave me a totally useless aspirin on discharge.

Two days later I had my 2D TEE there to look for what Dr N suspected was a late LARIAT leak that had just been noticed in the prior few months to be occurring in roughly 5% of LARIAT cases. We discovered in my case that a 2D TEE is not resolving enough to accurately and consistently detect these small LAALeaks after a Lariat suture loosens slightly many months after an initially successful closure

His highly skilled TEE Cardiologist at St Davids felt that what Dr Natske Troy certain showed a small Luke of a leak , was in fact just an artifact and not a leak at all. Dr Natale examined the TEEcclosely overnight and insisted he felt certain there was a leak though it was difficult to confirm on the 2D image so he sent me to Scripps In La Jolla with their renowned imaging center and one of the top TEE docs in the US and his S fills colleague Dr David Rubensen to confirm if here was indeed a leak. After a special MagnaSafe protocol MRI which was required since I have a pacemaker, that discovered not one but two 1cm frontal lobe lesion from the stroke right where LAA sourced embolic debris would tend to wind up in the brain, Dr Rubensen next confirmed the leak instantly and easily seen via the higher resolution crystal used in the head sensor of a 3DTEE probe.

I then had the leak plugged to return me to my prior very low stroke risk before the Lariat opened up on me and caused reconnected blood flow from my Remnant partly necrotic LAA pouch with my main blood stream in the LA, sending embolic debris to my brain and I was extremely lucky to not have been more seriously impaired.

Had Dr N not had the experience and confidence to be able to see within that very fuzzy and equivocal 2D TEE image and recognize that small leak plume, when a highly experience TEE specialist in Austin felt just as confident I did not have an LAA leak, then I would have been sent home with a mystery as to wavy caused what they assumed was just a TIA when it was a more serious stroke... And almost certainly I would have had another and likely far more consequential stroke that at the very least would likely have removed me from being on this forum,if not far worse.

And ask a young ablation patient of Dr N,s and forum participant a lot last year who had had a couple of heart surgeries in his teens for congenital PFO hole leaks through his atrial septum which had been repaired by the long ago cardiac surgeon using a square sheet of Gortex that was embedded and endothelial covered over on his atrial septal wall.

No surgical notes were available to add Natale dis dining this old fashion use of Gortex in this patient so many years prior. So when Dr N goes in to start the ablation with a routine transeptal puncture he is immediately surprised by what was a near impenetrable extremely tough Gortex barrier embedded within what had become a very thickened scar tissue laden left atrial septum.

He labored for three full hours and had to create, on the spot, a new method for penetrating this tough springy trampoline like material and keep it open long enough to insert the catheter sheaths within which to guide the mapping and ablation catheter into his heart. Dr DiBiase, his protege who was assisting in this procedure, told me later that Dr Natale wound up trying a series of ever larger balloons threaded over a guide wire before they finally went to a huge largest diameter ballon in the arsenal needed to prop open the hole long enough to quickly thread the sheath and catheters in to John's left atrium before the thick meaty scar tissue laden septum collapsed again sealing any entry to the LA.

Dr DiBiase at about the one hour mark into this three hour transeptal puncture asked Dr Natale if he wanted to call it a day and abort this ablation as he said "Shannon, I can promise you there is not a single EP or interventional Cardio in the world who would have continued on trying to figure out a way to make this work after an hour of effort to do what normally takes 5 minutes!

But Dr Natale, knowing that John had both AFIB and VT and has really had to struggle with a lifetime of Cardiac problems in his early 30s said: 'we have to give this young man his life back" and continued on for two additional hours until he was finally successful at establishing two transeptal punctures through this nearly impenetrable barrier and competed the ablation which from then on was routine after that most challenging first step!

Again, these are just two examples of why it really pays to go to the most experienced and cutting edge operator you can possibly arrange for yourself. I hope that clarifies the choices for you. Only an innovator and pioneer type spirit would have pulled off either of those two scenarios successfully and there are so many more similar stories that I know of as well with this physician I've learned not to do a lot of second guessing.

Shannon

Shannon, That is quite a story about the Gortex repaired PFO and trying to do a transeptal puncture through it. I wonder what the reason was that he didn't even consider going retrograde and avoiding all of that trouble since it sounds like he had to reach the LV anyway. Perhaps the Stereotaxis system was already tied up in a long VT procedure.

Hi Researcher,

In John's ablation he did only the AFIB part first and the a at portion is on hold as he has been clear of VT for a while now. So he was not going that route . When doing a left sided Extended PVAI with non PV triggers as well it's very important to have a very good line and angle through the right to left septal wall... A little too high or coming from a very different orientation as in retrograde VT approach would make it quite difficult to get good angles in his targets in the LA.

This why Dr N slugged it out until successful
In the preferred approach. The main reason for the story too was as just one of many such varied stories of real
Time innovation he has had to address during se of his complex ablations, as yet another reason for choosing a highly experienced operator in his ball park for any ablation that might remotely be more involving that the simplest PVI alone.

Shannon

From looking at something else today, my understanding is that it is logistically impossible to switch from manual to Stereotaxis once a procedure starts. So that would be another reason for him to slug it out. If he knew going in how difficult it was to cross a GoreTex patch, I think he may well have done it retrograde. The other possibility is that John had a lot of calcification around his aortic valve and that would be another reason not to go there. Linked article below provides description of retrograde access for AF ablation when transseptal approach is not possible or safe.

[www.ncbi.nlm.nih.gov]



Edited 1 time(s). Last edit at 08/17/2015 10:39AM by researcher.