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Any one heard of this proceedure

Posted by Janet 
Any one heard of this proceedure
March 01, 2013 03:15AM
Re: Any one heard of this proceedure
March 01, 2013 12:43PM
Janet, Yes. I have posted about the laser balloon here so you can do a search here using those keywords. The procedure is experimental and the company behind it is sponsoring human trials. I would avoid being recruited into the trials as the European trial results so a very high rate of tamponade, and those results came from a top center in Germany. I cringed to think what would happen with the device at lesser skilled centers..
Re: Any one heard of this proceedure
March 01, 2013 04:07PM
The proceedure was featured in an Australian programme called Heart Starters shown on TV last night, as a person with 3 failed conventional ablations behind me i am very interested in anything that is new on the ablation front, so will be having a look at the episode myself today.
Using your search words balloon laser I cant find anything posted so far on this board can you point me in the right direction?



Edited 1 time(s). Last edit at 03/01/2013 04:12PM by Janet.
Re: Any one heard of this proceedure
March 01, 2013 06:51PM
This might be what you are looking for, Janet: [www.uclh.nhs.uk]
Re: Any one heard of this proceedure
March 02, 2013 04:17PM
Janet,

The type of equipment used in performing an ablation is of very minor importance. The all important factor is the skill and experience of the EP doing the procedure. If you are considering going to Australia for a procedure I would recommend either Dr. Prash Sanders at Royal Adelaide Hospital or Dr. Rukshen Weerasooriya at Royal Perth Hospital. They both trained with Pr. Haissaguerre in Bordeaux.

Hans
Re: Any one heard of this proceedure
March 02, 2013 06:35PM
Hi Neroli.B

Thanks that is exactly what I was looking for, do you have any thoughts on the proceedure?
Re: Any one heard of this proceedure
March 02, 2013 08:54PM
Janet, I have to confess I was not familiar with it until I went looking for it. It sounds interesting, but I don't know that I would want to be one of the first to rush in. I tend to side with researcher, wait for it to become better established and let them gain more experience with it before making up your mind.
Re: Any one heard of this proceedure
March 02, 2013 10:04PM
Janet, I couldn't find it so maybe I didn't post it. Anyway, here is the relevent discussion from the multicenter trial - one year followup. Lots of issues to iron out.

Title of paper is "One-year clinical outcome after pulmonary vein isolation using the novel endoscopic ablation system in patients with paroxysmal atrial fibrillation"

///////////////////////////////
Discussion
The current study is the first reporting the 1-year follow-up after PVI using the novel EAS. This study found that (1) longer-term follow-up results after EAS-based PVI are comparable with established ablation systems, (2) the major determinant of clinical recurrence of AF seems to be electrical reconduction of previously isolated PVs, and (3) no PV stenosis occurred by correlating the initial cardiac MRI to repeat MRI 3 months postablation.

Balloon-based ablation devices using different energy sources (e.g., cryothermal energy, hot balloon, HIFU) for the treatment of PAF have been introduced. Due to severe complications in the form of atrial-to-esophageal fistula, the HIFU balloon is no longer in clinical use.19 The cryoballoon has proven feasibility, safety, and efficacy in the treatment of PAF.10, 11, 12, 13 But due to its noncompliant balloon and its binary energy delivery, it does not allow for individual lesion sets respecting individual PV size and PV anatomy.

The first-generation EAS catheter was also designed as a noncompliant balloon device equipped with a fixed laser arc of 90°.17 In an initial first-in-human multicenter clinical feasibility phase in 30 patients suffering from PAF, the 12-month drug-free rate of freedom from AF was 60%.17

However, the novel EAS consists of a compliant balloon, and therefore allows for adaption on individual PV size and anatomy. In addition, the laser arc of 30° allows for very discrete lesions. The laser energy is titratable and is applied under direct visualization of the respective PV ostium to guide catheter ablation of the left atrium–PV junction.

The short-term success rate of 80% after EAS-based PVI, defined as freedom of AF, was promising.18 In the current analysis, we focused on midterm follow-up in a cohort of 40 patients, including 30 patients previously assessed for feasibility, safety, and acute efficacy of PVI utilizing the EAS.18 We found that 24 of 40 (60%) patients treated with the novel EAS were free of symptomatic and/or documented recurrence suggestive of AF after a median follow-up period of 402 days, including a blanking period of 3 months. That success rate is comparable to published follow-up data after cryoballoon-based PVI in patients with PAF.22, 23 It might be speculated that growing numbers of EAS-based PVIs and consequently a growing experience in the use of the system might even improve the results.

Most of AF recurrences (13 of 16) after EAS-based PVI occurred during the first 6 months of follow-up. Regarding repeat PVI procedures, the major determinant of clinical recurrences seems to be electrical reconduction of previously isolated PVs. That correlates to the experience with circumferential RFC-based PVI and might indicate the failure to achieve permanent transmural ablation lesions.9, 20

Defining the appropriate laser energy setting will require further investigation. The use of higher power settings may herald the benefits and increase the risk of peripheral damage to adjacent anatomical structures such as the esophagus or the phrenic nerve. The incidence of esophageal thermal lesions after EAS-based PVI was previously described at 18% (43% minimal thermal lesions, 57% thermal ulcerations).21 That correlates to published data about the incidence of thermal esophageal trauma after RFC-based24, 25 or cryothermal-based PVI.26, 27 No atrial-to-esophageal fistula occurred.

One ablation-related clinically asymptomatic phrenic nerve palsy occurred and has completely recovered in a repeat fluoroscopy performed 9 months after ablation. The incidence of phrenic nerve palsies after EAS treatment seems to be moderate compared with other balloon-based ablation systems but needs further investigation.10, 15, 23

Because the EAS is not designed as an over-the-wire system, it is sometimes challenging to direct and stabilize the balloon catheter within the LA or the respective PV. That fact may have contributed to the occurrence of 2 periprocedural tamponades in our study due to perforation of the LA roof and the LA appendage.

Considering other possible ablation-related complications using the novel EAS, we could rule out significant PV stenosis by correlating a preinterventional cardiac MRI with a repeat MRI 3 months postablation.

Procedure times are comparable with those of established balloon-based ablation systems.10 Fluoroscopy times of 30 ± 17 minutes may be considered rather long, but were reduced significantly between the first 20 and the last 20 procedures (37 ± 19 minutes vs. 23 ± 11 minutes; P < .05). However, studies providing higher patient numbers and longer follow-up periods are mandatory for further investigation of the novel EAS.
Re: Any one heard of this proceedure
March 03, 2013 12:04PM
Janet,

The cost of going to Australia for an ablation would be at least $40k. The cost of the same from Bordeaux is $20k plus you have to get there and stay a couple of weeks, say $10k for 2 people, so you may as well go to Bordeaux and have it done by the very best.

Colin
Re: Any one heard of this proceedure
March 04, 2013 04:44AM
Hi all

My 3rd ablation lasted 7 months, I thought I had been cured but im not, I dont want to go through the same thing again, my EP is well known in New Zealand he ablates the famous as well as the ordinary man or woman I doubt it was his fault it didnt work, i am a persistent afibber so always going to be a challenge.
Maybe looking at new proceedures im clutching at straws but I dont see the point in going to France it wont offer me anything i havent already had.
If it had been my one and only failure I might have thought it a possibilty but it wasnt.
Researcher thank you for the posting ,maybe there is a way to go on that one but I will be following its progress

Janet



Edited 2 time(s). Last edit at 03/04/2013 07:01PM by Janet.
Re: Any one heard of this proceedure
March 08, 2013 03:55PM
Janet,
Please listen to HAns and researcher here, its not the technology that failed you do far. Its the person behind it and perhaps you've had a difficult case too... all the more reason to go for only the top elites after 3 incomplete ablations. Just remember the very best elite operators all have access to and help develop the next cutting edge gear. Let them sort out what is best to use in your case and don't get overly swayed by news reports and whiz bang writes ups on the latest gizmo. If its a real breakthrough the best will be the first to adopt it. Laser balloons have a good ways to go to prove they can be at least as safe as the best RF catheters.

Shannon
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