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FIRM ablation for AF goes down in flames
Posted by researcher
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FIRM ablation for AF goes down in flames May 11, 2016 02:57PM |
Registered: 12 years ago Posts: 616 |
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Re: FIRM ablation for AF goes down in flames May 12, 2016 07:20AM |
Admin Registered: 11 years ago Posts: 2,779 |
Thanks Researcher,
I was just getting ready to write my own review of this major OASIS Randomized Control Trial presentation, as I was there too at the Heart Rhythm Society Scientific Sessions 2016 Conference all last week in San Francisco, and as a member of the media I attended the lifting of the press embargo on the Oasis trial as well as several other interesting late-breaking clinical trials presented at HRS this year. Dr. Natale gave the first press briefing to the media just before he went to the large hall to announce the results of this important OASIS RCT to the world.
As noted in the Medscape article you posted above, so please, anyone interested in this ground-breaking and important randomized trial result, do read the Medscape article link above in researcher's original thread post.
Those of you who read the last issue of The AFIB Report may also recall I wrote a review of where FIRM mapping and ablation stood as of early 2016. We learned that the latest several truly independent studies looking at FIRM ablation, including the first smaller arm of this OASIS-RCT released last December, all showed dramatically different and significantly worse outcomes from either FIRM used alone or FIRM plus a typical PVI/PVAI ablation, than was reported in the first handful of FIRM positive studies that were largely done either in conjunction with, or support from, the system developer, company and/or by other centers that had significant contributions from FIRM in their studies, and none of which used randomize data with rigorous methodology.
The most recent handful of studies performed prior to this release of the complete OASIS RCT, which so far is the only RCT on FIRM yet done, and these other more recent studies including OASIS (2015-2016 FIRM related research) were all done by more independent centers than were the first handful of largely positive studies. What really struck me too was that both sets of studies (the early positive and later disappointing studies) showed such a directly opposite outcome and efficacy for FIRM alone or FIRM plus PVAI from each other, a finding that is certainly not what either any of us afibbers as potential ablation patients, and certainly not FIRM proponents, would have hoped to see from this latest group of research on this first effort at rotor mapping and ablation.
After all, any new system that promised a far easier to perform and higher efficacy ablation with just a handful of burns required in order to achieve reportedly outstanding long-term freedom from AFIB, even for persistent and LSPAF, long-standing persistent AFIB, as well as paroxysmal cases, and all in the hands of even less experienced EPs than is typically required for consistently robust results with PVI and extended PVAI plus non-PV trigger ablation approaches, not only sounded too good to be true, as it turns out it apparently is not all it was cracked up to be, at least in this current iteration of FIRM from the weight of this collective evidence over the past 18 months or so. Not to mention now with the first RCT confirming the same poor outcomes that the majority of the most recent independent FIRM studies have found,.
Nevertheless, in our AFIB Report summary on the state of FIRM earlier this year, I noted that in spite of the conflicting results a lot was riding on the final results of this OASIS RCT due out within the following six months. Indeed, had FIRM proven to work consistently well in this major RCT, that would have been very welcome news indeed and offering us one more excellent tool both EPs and patients could rely on.
In any event, as the Medscape article above details, this is the first randomized controlled trial, and is a very solidly-executed trial, examining FIRM in a rigorous manner and performed as well by some of the most experienced and respected AFIB ablationist anywhere. OASIS-RCT was also guided overall by the largest AFIB research and ablation center in the world. And yet, alas, the FIRM mapping and ablation strategies here showed a very poor overall outcome in both cohort groups that employed FIRM ablation modules, etiher as a stand-alone procedure or in combination with a PVAI ablation.
All 3 Groups included well-matched cohorts of only persistent and LSPAF patients none of whom had ever had a prior ablation (important in getting clean comparative data) that could muddy the waters some of just want was contributing to what. (Most of the non-randomized data from the earlier 3 to 4 positive studies was a broad mix of different classes of afibbers with a significant percentage having had a prior PVI ablation before then getting having FIRM + PVI follow-up ablation in the majority of cases as well // a lot of moving balls being juggled here).
Group 1 (29 total non-paroxysmal) of OASIS used FIRM mapping and ablation only, however it was canceled early due to futility from lack of efficacy ... ouch.
Group 2 (42 non-paroxysmal) of OASIS used FIRM plus an extended PVAI ablation including posterior wall isolation and got 52% success at one year off all AAR drugs, which is close to the same level as a standard PVAI alone done by these elite centers ... in other words no appreciable added improvement over the PVAI alone was noted from the additional FIRM mapping and ablation.
Finally, OASIS Group 3 (42 non-paroxysmal) was the control group using No FIRM mapping/ablation at all and just compared the other two groups to a state of the art and well-vetted PVAI + Posterior Wall Isolation + Non-PV trigger ablation for these more complex non-paroxysmal cases, and they achieved a very healthy result of 76% success rate without including the LAA isolation phase that is not infrequently indicated for these most difficult classes of patients, especially LSPAF class patients. And this very good result was from just one procedure at 12 months post ablation showing freedom from all arrhythmia and off all AAR drugs.
The OASIS Group 2 FIRM + PVAI group also took a good deal longer and required more Xray exposure than did the control Group 3 doing only the core extended PVAI + Posterior Wall Iso + Non-PV trigger ablation.
At the end of Dr Natale's presentation at the HRS press briefing, and then right afterward when he presented the full Oasis RCT results to likely the largest single audience I saw at HRS and who were gathered in a huge hall to witness this OASIS RCT reveal as one of the most anticipated talks of the 4.5 day conference, Dr. Natale was asked by a reporter: "Dr. Natale does this now finally mean the end of FIRM?"
Being diplomatic, Dr Natale said: "Well perhaps it may represent the end of this current iteration of FIRM rotor mapping for our center and likely other centers too, but not necessarily the end of rotor mapping via other approaches either from other company's and centers or by the FIRM group making substantial improvements to this approach".
He noted too in the press briefing earlier that these poor results not only from the last few independent studies, but now reinforced by this OASIS RCT confirmation plus a new non-randomized Norwegian study released just a few weeks ago using FIRM-only mapping and ablation in paroxysmal case that showed a similar near futility as OASIS got with non-paroxysmal cases, but in this study with a cohort of only paroxysmal patients.
Dr. Natale then noted that these results could be caused, in part, from a possible faulty or flawed algorithm this version of FIRM 'might' be based on. Or these recent series of disappointing outcomes could partially be due to the basket catheter FIRM uses which leaves too large of gaps in coverage of the left atrium, and Natale noted too that it would be nearly impossible to build a basket catheter that fully covered the entire variable and odd-shaped LA interior surface area.
In addition, Dr Natale also emphasized that a number of top AFIB researchers and scientists had demonstrated compelling arguments and research indicating that while rotors can be detected by mathematical models, there is honest debate whether or not there is any intrinsic value in attempting to ablate these often meandering and often transitory time unstable rotors that are typically seen. It could also be that the poor results indicate a potential limitation in the whole theory that 'rotors are a key driver of AFIB'.
Finally, Dr. Natale also noted that as far as the current version of FIRM mapping is concerned, in his view it is the end of its use at his centers and no more FIRM ablation will be attempted there unless, and only when and if, a more compelling modification of the FIRM approach and/or software gives him and other AFIB researchers good reason to expect a better result. Natale noted too that these OASIS RCT findings may well force many other centers to put on hold or drop any further FIRM ablation so long as no significant improvement in the approach and software is first made.
That being said, Dr Natale also noted that it remains possible that some better results from rotor mapping and detection using a different approach and system might still be shown, and that OASIS RCT results certainly did not rule that possibility out.
Concepts like with CardioInsight's external vest-based non-invasive phase mapping system that Bordeaux is busy investing effort and money in and experimenting with, might possibly show more promise combined with Bordeaux's EAM (electroanatomic mapping strategies) using CARTO3 and/or ENSITE along with data from the non-invasive surface mapping with the Cardioinsight vest captured the day before the ablation.
However, based on this experience with FIRM, I imagine most everyone in the field is going to demand full well-constructed randomized control trials, and not get too excited and over the moon on face value based on only non-randomized data on these new rotor mapping approaches from any centers. Especially those heavily invested in any new technology and at least not until at least one or more truly independent RCTs can verify the replicable efficacy of any such new system.
Until then, the list of ongoing non-randomised studies and data that until now have been the only type applied to FIRM investigations, and so far the only type of data applied to CardioInsight studies too (as far as I know) dictates that prudence and a dose of caution still are in demand and that we look at any less rigorous data and reports to be mainly hypothesis-generating at this time rather than grant them too much inherent credence on face value in lieu of solidly derived randomized data we can all rely on.
The dustbins of the history of medical innovation are littered with many very promising sounding breakthroughs and new technologies that were avidly and with great conviction promoted early by their developers and proponents as game-changing technology based on similar non-randomized early data, and in hindsight too, often physicians wound up kicking themselves for jumping the gun too early and embracing such new tech well before the more rigorous proof of concept had been independently verified through such well-structured RCTs.
Andrea Natale concluded his remarks saying (in paraphrase): that while it is important research investigating rotor mapping and ablation, in this case, it represents a missed opportunity for our field in that FIRM was allowed to go on for five years before an actual independent RCT was performed to prove whether or not it even worked in a reliable and independently replicable fashion. Thus, the real lesson here is that this should never have taken so long as it may well have had real consequences for patients and physicians alike, not the least of which in impacting sound decision making for patients.
In any event, this OASIS-RCT was certainly a big bombshell for many at the HRS conference, though some may well have half-expected that this could be the result based on the poor showing from the last few independent studies released in 2015 and early 2016. I was hoping that the full OASIS-RCT might at least show a ray of light for FIRM and point the way toward future development using this technology to eventually improve understanding all around.
Nevertheless, at this point the facts are what they are, and I could not in good conscience recommend FIRM ablation to any of our readers going forward with the current system as it is. Not when there are clearly more reliable alternative approaches that deliver better results more consistently than what these latest studies have shown is the real world outcome using solid real-world randomized data with the current version of this technology.
The hard part, is that these later more rigorous studies, including this solid OASIS RCT were not only not as supportive of FIRM in their results, the results from these last 3 or 4 studies told an entirely different and opposite story from the early publications of non-randomized data and less rigorous study structure that could not come close to being duplicated by this highly-experienced world class ablation center in Austin and San Franciso as well as in Hamburg Germany.
It's one thing and somewhat understandable when the studies more or less done with assistance from a device maker or developer show very positive results, and then independent studies and early RCTs on the same methods or tools tell a bit less robust story, but at least are still confirming and telling a similar story in the same ball-park of efficacy. It may be only natural for at least a bit of in-house 'gilding of the lily' to inadvertently seep into the works at times. But as long as the independent and long-term outcomes mostly confirm the initial reports that shouldn't pose a real problem.
However, to have all these most recent findings on FIRM, including now this first big multicenter RCT, to show such diametrically opposite results compared to the far more positive results out of the mostly FIRM-guided studies published in the first few years of the FIRM bandwagon, is a tough one to reconcile.
"As EP specialist" Natale concluded, "we EPs and Cardiologists need to insist on demanding that well-done RCTs on important new technology be done early in development so as not to confuse for too long both EPs and, more importantly, AFIB patients alike."
Topera and its principals had already sold the company and the FIRM mapping system and software to Abbott Medical for around $250 million dollars about a year and a half ago, well before this OASIS-RCT, and obviously before any other RCT had been released to confirm if the systems efficacy could be independently proved and verified with such an all new technology. There is nothing wrong with that inherently, it's how business often works these days with the early bird taking a risk to potentially gain a price and profit advantage over a potential competitive buyer. But as a field of medicine, Natale is urging more urgency in demanding reliable very well-vetted RCT data earlier on in the process.
Nevertheless, I do want to emphasize, too, that in spite of these disappointing results accumulated now over the most recent handful of studies and along with this OASIS RCT, they do not mean or imply that people who had a FIRM-based ablation did not realize any benefit. Whether or not FIRM mapping and ablation itself was responsible for whatever benefit a given patient experienced via such a procedure, the vast majority of FIRM-based ablations included a PVi/PVAI ablation too. And for many patients, a well done PVAI/PVI alone can deliver excellent long-term results. What these studies call into question was what part, if any at all, that FIRM mapping and ablation itself contributed to those good outcomes?
OASIS-RCT basically said that whatever benefit the patients from these three cohorts in this RCT experienced after 12 months, the contribution of the FIRM mapping and ablation phases in two of these three groups was minimal at best, and we can't rule out the possibility that nearly all of the benefit was primarily due to the better-vetted PVI/PVAI ablation procedures. In the OASIS FIRM-only ablation Group 1, even the rather abysmal 14% success rate at 12 months from using FIRM ablation alone with this challenging class of afibbers could largely be attributed to AAR drug therapy (Amiodarone) used in those specific patients making up the 14% success rate (9 out of 29 total patients who got FIRM-only ablation), and possibly very little due to FIRM ablation itself. Hence, why this arm was canceled early due to futility.
We do learn many valuable lessons from this kind of research, even when the outcome may not have been what most would have preferred to discover. I'm sure we have not heard the last word on rotor-mapping and ablation and it will be interesting to watch as we ultimately learn the full utility, or possibly lack thereof, of trying to pursue rotors as an ablation target in AFIB.
Shannon
Edited 14 time(s). Last edit at 07/07/2016 05:58AM by Shannon.
I was just getting ready to write my own review of this major OASIS Randomized Control Trial presentation, as I was there too at the Heart Rhythm Society Scientific Sessions 2016 Conference all last week in San Francisco, and as a member of the media I attended the lifting of the press embargo on the Oasis trial as well as several other interesting late-breaking clinical trials presented at HRS this year. Dr. Natale gave the first press briefing to the media just before he went to the large hall to announce the results of this important OASIS RCT to the world.
As noted in the Medscape article you posted above, so please, anyone interested in this ground-breaking and important randomized trial result, do read the Medscape article link above in researcher's original thread post.
Those of you who read the last issue of The AFIB Report may also recall I wrote a review of where FIRM mapping and ablation stood as of early 2016. We learned that the latest several truly independent studies looking at FIRM ablation, including the first smaller arm of this OASIS-RCT released last December, all showed dramatically different and significantly worse outcomes from either FIRM used alone or FIRM plus a typical PVI/PVAI ablation, than was reported in the first handful of FIRM positive studies that were largely done either in conjunction with, or support from, the system developer, company and/or by other centers that had significant contributions from FIRM in their studies, and none of which used randomize data with rigorous methodology.
The most recent handful of studies performed prior to this release of the complete OASIS RCT, which so far is the only RCT on FIRM yet done, and these other more recent studies including OASIS (2015-2016 FIRM related research) were all done by more independent centers than were the first handful of largely positive studies. What really struck me too was that both sets of studies (the early positive and later disappointing studies) showed such a directly opposite outcome and efficacy for FIRM alone or FIRM plus PVAI from each other, a finding that is certainly not what either any of us afibbers as potential ablation patients, and certainly not FIRM proponents, would have hoped to see from this latest group of research on this first effort at rotor mapping and ablation.
After all, any new system that promised a far easier to perform and higher efficacy ablation with just a handful of burns required in order to achieve reportedly outstanding long-term freedom from AFIB, even for persistent and LSPAF, long-standing persistent AFIB, as well as paroxysmal cases, and all in the hands of even less experienced EPs than is typically required for consistently robust results with PVI and extended PVAI plus non-PV trigger ablation approaches, not only sounded too good to be true, as it turns out it apparently is not all it was cracked up to be, at least in this current iteration of FIRM from the weight of this collective evidence over the past 18 months or so. Not to mention now with the first RCT confirming the same poor outcomes that the majority of the most recent independent FIRM studies have found,.
Nevertheless, in our AFIB Report summary on the state of FIRM earlier this year, I noted that in spite of the conflicting results a lot was riding on the final results of this OASIS RCT due out within the following six months. Indeed, had FIRM proven to work consistently well in this major RCT, that would have been very welcome news indeed and offering us one more excellent tool both EPs and patients could rely on.
In any event, as the Medscape article above details, this is the first randomized controlled trial, and is a very solidly-executed trial, examining FIRM in a rigorous manner and performed as well by some of the most experienced and respected AFIB ablationist anywhere. OASIS-RCT was also guided overall by the largest AFIB research and ablation center in the world. And yet, alas, the FIRM mapping and ablation strategies here showed a very poor overall outcome in both cohort groups that employed FIRM ablation modules, etiher as a stand-alone procedure or in combination with a PVAI ablation.
All 3 Groups included well-matched cohorts of only persistent and LSPAF patients none of whom had ever had a prior ablation (important in getting clean comparative data) that could muddy the waters some of just want was contributing to what. (Most of the non-randomized data from the earlier 3 to 4 positive studies was a broad mix of different classes of afibbers with a significant percentage having had a prior PVI ablation before then getting having FIRM + PVI follow-up ablation in the majority of cases as well // a lot of moving balls being juggled here).
Group 1 (29 total non-paroxysmal) of OASIS used FIRM mapping and ablation only, however it was canceled early due to futility from lack of efficacy ... ouch.
Group 2 (42 non-paroxysmal) of OASIS used FIRM plus an extended PVAI ablation including posterior wall isolation and got 52% success at one year off all AAR drugs, which is close to the same level as a standard PVAI alone done by these elite centers ... in other words no appreciable added improvement over the PVAI alone was noted from the additional FIRM mapping and ablation.
Finally, OASIS Group 3 (42 non-paroxysmal) was the control group using No FIRM mapping/ablation at all and just compared the other two groups to a state of the art and well-vetted PVAI + Posterior Wall Isolation + Non-PV trigger ablation for these more complex non-paroxysmal cases, and they achieved a very healthy result of 76% success rate without including the LAA isolation phase that is not infrequently indicated for these most difficult classes of patients, especially LSPAF class patients. And this very good result was from just one procedure at 12 months post ablation showing freedom from all arrhythmia and off all AAR drugs.
The OASIS Group 2 FIRM + PVAI group also took a good deal longer and required more Xray exposure than did the control Group 3 doing only the core extended PVAI + Posterior Wall Iso + Non-PV trigger ablation.
At the end of Dr Natale's presentation at the HRS press briefing, and then right afterward when he presented the full Oasis RCT results to likely the largest single audience I saw at HRS and who were gathered in a huge hall to witness this OASIS RCT reveal as one of the most anticipated talks of the 4.5 day conference, Dr. Natale was asked by a reporter: "Dr. Natale does this now finally mean the end of FIRM?"
Being diplomatic, Dr Natale said: "Well perhaps it may represent the end of this current iteration of FIRM rotor mapping for our center and likely other centers too, but not necessarily the end of rotor mapping via other approaches either from other company's and centers or by the FIRM group making substantial improvements to this approach".
He noted too in the press briefing earlier that these poor results not only from the last few independent studies, but now reinforced by this OASIS RCT confirmation plus a new non-randomized Norwegian study released just a few weeks ago using FIRM-only mapping and ablation in paroxysmal case that showed a similar near futility as OASIS got with non-paroxysmal cases, but in this study with a cohort of only paroxysmal patients.
Dr. Natale then noted that these results could be caused, in part, from a possible faulty or flawed algorithm this version of FIRM 'might' be based on. Or these recent series of disappointing outcomes could partially be due to the basket catheter FIRM uses which leaves too large of gaps in coverage of the left atrium, and Natale noted too that it would be nearly impossible to build a basket catheter that fully covered the entire variable and odd-shaped LA interior surface area.
In addition, Dr Natale also emphasized that a number of top AFIB researchers and scientists had demonstrated compelling arguments and research indicating that while rotors can be detected by mathematical models, there is honest debate whether or not there is any intrinsic value in attempting to ablate these often meandering and often transitory time unstable rotors that are typically seen. It could also be that the poor results indicate a potential limitation in the whole theory that 'rotors are a key driver of AFIB'.
Finally, Dr. Natale also noted that as far as the current version of FIRM mapping is concerned, in his view it is the end of its use at his centers and no more FIRM ablation will be attempted there unless, and only when and if, a more compelling modification of the FIRM approach and/or software gives him and other AFIB researchers good reason to expect a better result. Natale noted too that these OASIS RCT findings may well force many other centers to put on hold or drop any further FIRM ablation so long as no significant improvement in the approach and software is first made.
That being said, Dr Natale also noted that it remains possible that some better results from rotor mapping and detection using a different approach and system might still be shown, and that OASIS RCT results certainly did not rule that possibility out.
Concepts like with CardioInsight's external vest-based non-invasive phase mapping system that Bordeaux is busy investing effort and money in and experimenting with, might possibly show more promise combined with Bordeaux's EAM (electroanatomic mapping strategies) using CARTO3 and/or ENSITE along with data from the non-invasive surface mapping with the Cardioinsight vest captured the day before the ablation.
However, based on this experience with FIRM, I imagine most everyone in the field is going to demand full well-constructed randomized control trials, and not get too excited and over the moon on face value based on only non-randomized data on these new rotor mapping approaches from any centers. Especially those heavily invested in any new technology and at least not until at least one or more truly independent RCTs can verify the replicable efficacy of any such new system.
Until then, the list of ongoing non-randomised studies and data that until now have been the only type applied to FIRM investigations, and so far the only type of data applied to CardioInsight studies too (as far as I know) dictates that prudence and a dose of caution still are in demand and that we look at any less rigorous data and reports to be mainly hypothesis-generating at this time rather than grant them too much inherent credence on face value in lieu of solidly derived randomized data we can all rely on.
The dustbins of the history of medical innovation are littered with many very promising sounding breakthroughs and new technologies that were avidly and with great conviction promoted early by their developers and proponents as game-changing technology based on similar non-randomized early data, and in hindsight too, often physicians wound up kicking themselves for jumping the gun too early and embracing such new tech well before the more rigorous proof of concept had been independently verified through such well-structured RCTs.
Andrea Natale concluded his remarks saying (in paraphrase): that while it is important research investigating rotor mapping and ablation, in this case, it represents a missed opportunity for our field in that FIRM was allowed to go on for five years before an actual independent RCT was performed to prove whether or not it even worked in a reliable and independently replicable fashion. Thus, the real lesson here is that this should never have taken so long as it may well have had real consequences for patients and physicians alike, not the least of which in impacting sound decision making for patients.
In any event, this OASIS-RCT was certainly a big bombshell for many at the HRS conference, though some may well have half-expected that this could be the result based on the poor showing from the last few independent studies released in 2015 and early 2016. I was hoping that the full OASIS-RCT might at least show a ray of light for FIRM and point the way toward future development using this technology to eventually improve understanding all around.
Nevertheless, at this point the facts are what they are, and I could not in good conscience recommend FIRM ablation to any of our readers going forward with the current system as it is. Not when there are clearly more reliable alternative approaches that deliver better results more consistently than what these latest studies have shown is the real world outcome using solid real-world randomized data with the current version of this technology.
The hard part, is that these later more rigorous studies, including this solid OASIS RCT were not only not as supportive of FIRM in their results, the results from these last 3 or 4 studies told an entirely different and opposite story from the early publications of non-randomized data and less rigorous study structure that could not come close to being duplicated by this highly-experienced world class ablation center in Austin and San Franciso as well as in Hamburg Germany.
It's one thing and somewhat understandable when the studies more or less done with assistance from a device maker or developer show very positive results, and then independent studies and early RCTs on the same methods or tools tell a bit less robust story, but at least are still confirming and telling a similar story in the same ball-park of efficacy. It may be only natural for at least a bit of in-house 'gilding of the lily' to inadvertently seep into the works at times. But as long as the independent and long-term outcomes mostly confirm the initial reports that shouldn't pose a real problem.
However, to have all these most recent findings on FIRM, including now this first big multicenter RCT, to show such diametrically opposite results compared to the far more positive results out of the mostly FIRM-guided studies published in the first few years of the FIRM bandwagon, is a tough one to reconcile.
"As EP specialist" Natale concluded, "we EPs and Cardiologists need to insist on demanding that well-done RCTs on important new technology be done early in development so as not to confuse for too long both EPs and, more importantly, AFIB patients alike."
Topera and its principals had already sold the company and the FIRM mapping system and software to Abbott Medical for around $250 million dollars about a year and a half ago, well before this OASIS-RCT, and obviously before any other RCT had been released to confirm if the systems efficacy could be independently proved and verified with such an all new technology. There is nothing wrong with that inherently, it's how business often works these days with the early bird taking a risk to potentially gain a price and profit advantage over a potential competitive buyer. But as a field of medicine, Natale is urging more urgency in demanding reliable very well-vetted RCT data earlier on in the process.
Nevertheless, I do want to emphasize, too, that in spite of these disappointing results accumulated now over the most recent handful of studies and along with this OASIS RCT, they do not mean or imply that people who had a FIRM-based ablation did not realize any benefit. Whether or not FIRM mapping and ablation itself was responsible for whatever benefit a given patient experienced via such a procedure, the vast majority of FIRM-based ablations included a PVi/PVAI ablation too. And for many patients, a well done PVAI/PVI alone can deliver excellent long-term results. What these studies call into question was what part, if any at all, that FIRM mapping and ablation itself contributed to those good outcomes?
OASIS-RCT basically said that whatever benefit the patients from these three cohorts in this RCT experienced after 12 months, the contribution of the FIRM mapping and ablation phases in two of these three groups was minimal at best, and we can't rule out the possibility that nearly all of the benefit was primarily due to the better-vetted PVI/PVAI ablation procedures. In the OASIS FIRM-only ablation Group 1, even the rather abysmal 14% success rate at 12 months from using FIRM ablation alone with this challenging class of afibbers could largely be attributed to AAR drug therapy (Amiodarone) used in those specific patients making up the 14% success rate (9 out of 29 total patients who got FIRM-only ablation), and possibly very little due to FIRM ablation itself. Hence, why this arm was canceled early due to futility.
We do learn many valuable lessons from this kind of research, even when the outcome may not have been what most would have preferred to discover. I'm sure we have not heard the last word on rotor-mapping and ablation and it will be interesting to watch as we ultimately learn the full utility, or possibly lack thereof, of trying to pursue rotors as an ablation target in AFIB.
Shannon
Edited 14 time(s). Last edit at 07/07/2016 05:58AM by Shannon.
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Re: FIRM ablation for AF goes down in flames May 12, 2016 07:21AM |
Registered: 8 years ago Posts: 83 |
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Re: FIRM ablation for AF goes down in flames May 12, 2016 03:50PM |
Registered: 12 years ago Posts: 616 |
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Re: FIRM ablation for AF goes down in flames May 13, 2016 05:51AM |
Admin Registered: 11 years ago Posts: 2,779 |
Hi Peggy,
While researcher is right that you can access the Medscape article on the OASIS - Randomized Controlled Trial presented at HRS 2016 Conference last week in San Francisco, I imagine quite a few others here might also find it easier just to read a summary of the OASIS trial that Dr Natale's group conducted and that he reported on the results of last Friday at HRS. As such, I expanded what was going to be a shorter overview of the article, after researcher had posted that article link and thus those that find that a hassle to access can still get the gist of what OASIS was all about and why it was one of the most important studies presented at the HRS Scientific Sessions this year.
And this was my first Heart Rhythm Society annual conference and it was by far the most in-depth and broad-ranging EP-related event I have yet been too. Somewhere between 10,000 and 12,000 EPs and Cardiologists from around the world attended and one of the key topics presented via numerous presentations and studies reflected the rapidly emerging field within EP and cardiology of address the Left Atrial Appendage with electrical isolation, occlusion and closure by various means. It's amazing to me to see how dramatically this key LAA topic has risen to the forefront of these large conference focus over just the past 3 to 4 years!
With this rise in interest now of recognizing the many ways in which addressing both the arrhythmogenic risk and stroke risk of the LAA in AFIB, it just reinforces how our own long term forum and website focus on LAA issues and various LAA procedures so many of us here have had, certainly underscores that our website has been at the forefront of these progressive cutting edge advances in the field of electrophysiology for years now.
Shannon
Edited 1 time(s). Last edit at 05/13/2016 03:11PM by Shannon.
While researcher is right that you can access the Medscape article on the OASIS - Randomized Controlled Trial presented at HRS 2016 Conference last week in San Francisco, I imagine quite a few others here might also find it easier just to read a summary of the OASIS trial that Dr Natale's group conducted and that he reported on the results of last Friday at HRS. As such, I expanded what was going to be a shorter overview of the article, after researcher had posted that article link and thus those that find that a hassle to access can still get the gist of what OASIS was all about and why it was one of the most important studies presented at the HRS Scientific Sessions this year.
And this was my first Heart Rhythm Society annual conference and it was by far the most in-depth and broad-ranging EP-related event I have yet been too. Somewhere between 10,000 and 12,000 EPs and Cardiologists from around the world attended and one of the key topics presented via numerous presentations and studies reflected the rapidly emerging field within EP and cardiology of address the Left Atrial Appendage with electrical isolation, occlusion and closure by various means. It's amazing to me to see how dramatically this key LAA topic has risen to the forefront of these large conference focus over just the past 3 to 4 years!
With this rise in interest now of recognizing the many ways in which addressing both the arrhythmogenic risk and stroke risk of the LAA in AFIB, it just reinforces how our own long term forum and website focus on LAA issues and various LAA procedures so many of us here have had, certainly underscores that our website has been at the forefront of these progressive cutting edge advances in the field of electrophysiology for years now.
Shannon
Edited 1 time(s). Last edit at 05/13/2016 03:11PM by Shannon.
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