Biosense: guarenteed results or your money back

It turns out that J&J Biosense Webster is actually offering a money-back guarentee to EP's, if the EP uses the Biosense Webster Smart Touch catheter, and the patient returns for a second ablation within 12 months. Seems like a pretty bold offer, seeing as how so much of the ablation's success depends on the skill of the EP.

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In an earlier LAF discussion thread phased RF pulmonary vein ablation catheter --> 37% cranial lesions?
Shannon provided some very interesting insight into Dr. Natale's catheter choice:

Quote
Shannon
Dr. Natale uses primarily the Thermocool Smart Flow irrigated catheter and in some paroxysmal cases either of the two contact force catheters from St Jude Tacticath or Biosense Webster's Smart Touch, but he mostly prefers the Smart Flow.

Today I learned that not only does Dr. Natale use the Biosense Smart Touch, but Biosense actually references Natale's study in their ad for the Smart Touch catheter.

You can see this in the July 2015 issue of EP Digest magazine. On p5 is a full-page ad for the Biosense Webster Thermocool Smart Touch catheter, and at the bottom of the ad is the reference to Natale's study:

1. Natale A, Reddy V, Monir G, et al. Paroxysmal AF catheter ablation with a force sensing catheter: results of the prospective, multicenter SMART-AF Trial, J Am Coll Cardiol. 2014;64(7):647-656


Even more interesting is the money-back guarentee that Biosense is offering:

Quote

Our goal is to bring CARTO SMARTTOUCH Technology to all patients with paroxysmal atrial fibrillation (PAF). We are so confident that our technology will help you generate better outcomes for your PAF patients, we now stand behind it with an outcomes-based risk-sharing agreement.

Really? They are guarenteeing results? That sounds like a big risk for a hw manufacturer to take, seeing as ablations are so dependent on the skill of the EP.

Googling turned up the following Reuter's Business Insider (July 8, 2015) article,

Quote
Medical device makers beef up product guarantees to woo U.S. hospitals
CHICAGO (Reuters) - Medical device makers, facing sluggish sales and increasing pressure to prove the value of their products, are beefing up guarantees to compensate U.S. hospitals if a device does not perform as expected.
...
J&J's Biosense Webster unit has introduced risk-sharing for its Thermocool catheter ablation treatment for atrial fibrillation, a form of abnormal heart rhythm. Hospitals are given a discount on Biosense Webster devices used in a repeat procedure if a patient initially treated with those products returns within a year.

...
SPREADING THE RISK

In the past, medical device warranties would have covered the device only. For example, a manufacturer might pay for a patient’s new pacemaker if the battery on the original implant depleted sooner than expected.

Device makers and hospitals say the new agreements under discussion go further by tying a guarantee to trackable health outcomes. The manufacturers, who are struggling with weak demand and falling prices, are more willing to take on the additional risk to gain an edge in the marketplace.
...
J&J's Biosense Webster unit has introduced risk-sharing for its Thermocool catheter ablation treatment for atrial fibrillation, a form of abnormal heart rhythm. Hospitals are given a discount on Biosense Webster devices used in a repeat procedure if a patient initially treated with those products returns within a year.

By the way, in the Biosense Webster ad, there is an asterisk which explains:

Quote
Biosense
Success is defined as freedom from any symptomatic atrial arryhthmia (atrial fibrillation, atrial flutter, atrial tachycardia) 12 months postprocedure when operator remained in preset contact force range."

That sounds like a pretty strong guarentee. But upon second read, I realized that the refund only applies if the Biosense device is used in a second ablation, which occurs in a 12-month window after the first. In other words, the refund only applies if the arryhthmia is at the level that the patient consents to a 2nd ablation, and... if the EP decides to (once again) use the Biosense for the second ablation.



Edited 2 time(s). Last edit at 07/27/2015 06:05PM by apache.

So what does this mean? The Doctor saves money if he gets a patient to have a second Ablation with 12 months? The patient is no doubt totally unaware of this financial agreement and the savings would not be passed on the the patient. How much money are we talking about here? I guess Ablationist looks bad if the patient has some AFIB during the 1st year, but then he is rewarded if he can talk the patient into another Ablation.

The Ablationist should offer a flat fee that covers their prodecure(s) if they do a full index Ablation. At least within a certain period of time, like 5 years. If I go to get my car worked on, and I pay the 2500 for a rebuilt Transmission, then they give me a guarantee, for a set period of time, like 1-3 years. If they have to redo it 3 times, it's on them. This would take away from financial incentive for performing multiple Ablations, and make it less profitable for Ablationists with poor success records to keep performing unsuccesfull procedures.



Edited 2 time(s). Last edit at 07/27/2015 10:59PM by The Anti-Fib.

In most cases, I would imagine that the ins. company pays the majority of the cost of an ablation, so the Biosense Webster agreement is probably a non-issue as far as the patient is concerned. Rather, it's apparently meant to instill a sense of confidence in EP's, in selecting Biosense's catheter.

I'm just surprised that Biosense would make this guarentee in the first place, since the "one and done" scenario for afib ablations seems to be relatively rare, esp. if the first isn't done by a top EP.

Ted,

Dr Natale used the Smart Touch only in some cases he deems easy paroxysmal cases from the outset that will very likely not require more extensive ablation. He does get about 25% of such cases from his large work load but the majority over 75% are more challenging cases where he tends to prefer the SmartFlow over the Smart Touch.

And of course he was involved in the Biosense Webster Smart Touch trial and studies, and Dr N is among the very first they turn to in pioneering every new catheter with his international reputation, and his very large AFIB research center. He gets all the new toys before most anyone else to put them through their paces.

That does not imply that every new device he has explored and vetted that he uses frequently in his every day ablations. The marketing press releases notwithstanding.

And regarding that new guarantee about the Smart Touch, I can see where Bio-sense Webster probably feel its a smart or relatively safe bet. A front line, but not super highly experienced EP I know well, told me recently how much better his results have been since moving exclusively to the St Jude's Tacticath Contact Force catheter (which technically has some advantages even over the well regarded Smart Touch in the Contact Force catheter arena) telling me that his reconnection rates have dropped dramatically in his almost totally paroxysmal cohort of patients. He said over the last 40 patients he has done over the past 15 months with the Tacticath, only two have had to come back at this point.

These new catheters really do seem to help move the bar forward, especially for those who had a significant difficulty in getting consistent levels of transmural burns in their ablation patients and thus had a lot of reconnections and a lot of repeat customers.

Shannon

My guess is that this is about market share in paroxysmal cases where the popularity of cryo-balloon has grown. EP Lab digest latest issue has an article regarding Kuck's group in Hamburg (one of the highest volume groups in western EU) using the Artic Front in 30% of their cases. That would be most of the paroxysmal cases using average statistics for high volume centers. The selling point of cryo is that it has average efficacy but low perforation risk, that's an important benefit for the average and lower skilled centers when you look at the medicare statistics in Winkle's presentation. The jury is still out on Smart Touch as to whether it is the right tool at the average and lower skilled labs. FDA adverse reports continue to paint a mix picture if you do a search on the FDA MAUDE web page. But then there is the significantly increased risk of phrenic nerve injury using cryo-balloon. The best answer is still to pay attention to the skills and experience of the operator and not so much his tools. The best hands usually have access to all the tools anyway.



Edited 1 time(s). Last edit at 07/30/2015 03:23PM by researcher.

Vivek Reddy gave a nice presentation on force sensing catheters at St Jude sponsored symposium. See link below. There is concern expressed by the panel that fellows are not learning important manual skills and critical thinking when CF catheters are used. V. Reddy isn't so concerned and says it improves results for the less skilled operators and also his own.

The second video down

[www.innovationsincrm.com]