Had not before made comments on NYT reporting. But,.... this article troubles me gravely. Over the past decade or longer conflicts of interest have prevailed in the medical health community. This commentary aids and abets this history. I have become more and more responsible for my own health (in terms of treatment) - kinda scary in a general sense. Response below mine says "misleading." I say, seriously so.
3
Several of the doctors in this article sharing glowing praise for this device are paid by the device maker, Abbott. This should be disclosed in the article. Very troubling to see this poor reporting.
5
I’m a cardiologist who specializes in echocardiography and I’ve read the original study. This article is very misleading. The studied device does NOT treat all heart failure patients, only a relatively small subset who also have significant mitral regurgitation and symptoms despite maximal tolerated medical therapy. Additionally, this article is very misleading and does not recognize the major improvements in outcomes for patients with heart failure using modern medical therapy. After reading the full trial and reviewing the supplemental data, I agree this study was well done and is a “game-changer” for some patients, but only a minority of the millions of heart failure patients who have specific valve anatomy. I am surprised that The NY Times published such a poorly researched article.
22
So, we don't learn in this fine article until the 12th (!) paragraph what the name of the device is, and who makes it. Is the NYT so biased against business and entrepreneurial capitalism that it imagines these amazing products simply design and make THEMSELVES? Could, by chance, this most basic journalistic oversight also be the result of a further bias against private healthcare? Fail.
1
We vote ourselves into the worst healthcare in the developed world every chance we get. Enjoy the small government and deregulation we keep voting for. Trusting relegation of your healthcare to profit driven, multinational corporations is foolish. Then again we are poisoning the entire planet based on junk science, why not ourselves too?
2
I wonder if the control group got the same ‘standard’ of care. That alone could make the difference...
2
Ok the mitral valve flaps are stapled. What happens when heart continues to dilate and pulls the staple out! The trees look at the forest. This staple does nothing to stop or reverse pathophysiology of illness.
3
Is this clip available for use in small children? It actually sounds like what is needed for my 5 year old grandson who was born with hypoplastic left heart syndrome, which required 3 open heart surgeries to help his half of a heart be able to function. His last surgery was done in May at which point a pacemaker was also put in his stomach for his heart as the heart area is not big enough for the pacemaker to fit. He also had a stroke right after the surgery. Fortunately, the only struggle still remaining from the stroke is getting full control of his left arm and fingers.
Now his heart is enlarging and he struggles with physical activity and tires easily.
2
If one is that far gone, why would one want to spend thirty thousand dollars, an outrageous sum, on something that may or may not prolong one's life? Not only that, it doesn't sound all that new. Europe has been tinkering with it for a while, it seems. As to the cost, it represents what is so wrong with American medicine and health care in this country. Almost every device or drug seems to be made of gold dust.
8
@James Murphy, totally agree with you. This great device is out of range for almost everyone I know, it is tragic. Reducing medical costs and access to low cost drugs needs to be part of a platform for any political leader, and we as citizens need to demand it more often.
1
28.8% of the patients in the treatment-as-usual group died and 23.3% of the patients who got the clip died. I know this is a statistically significant difference, but how is it really clinically significant? Obviously, for the 5% of people who would have died with standard care but got the clip and lived, it is hugely significant. But really, in BOTH groups about 1 in 4 people died. How is this a game changer? There was another recent NYT article about a new "miracle" cure for migraines, but the effect size is tiny (something like 1 or 2 fewer days per month with a migraine, when the average was 15). These results may be highly statistically significant, but the effect sizes - the real measure of a treatment - are small and don't deserve the headlines they are generating.
16
Maybe anybody contemplating inserting this device should watch the documentary “Bleeding Heart” to see how much effort does the FDA make to regulate devices..... I hope that Gina Kolata saw it......
1
46% of control patients died vs 29% of treated patients.
1
@EBO. The article does not disclose the study which proved the device a “game changer” was run by the manufacturer of the device. No surprise results were stellar. A small study without conflicts found no benefit.
1
"all too often, heart failure patients do not receive ideal treatment." How can this be? If we know what ideal treatment consists of, why aren't patients given that treatment? If a doctor is not giving the best treatment, shouldn't he/she be called out on that? How can we continue to be the most expensive national for medical care if we aren't given the best care? And others know about this but do nothing.
9
After you’ve read this, read Ms. Kolata’s November 2017 article “For Patients With Heart Failure, Little Guidance as Death Nears”. What is the quality of life and transition to death like for patients with this device? How can we laud advances while putting them in a bigger context?
3
Judging from the comments made here it is clear that most people have no concept of what cardiac surgical medical intervention actually costs. While this is not a cure it is a way of keeping patients from constantly visiting the hospital via the emergency room, then being admitted for days in a cardiac ICU, costing $30,000 per incident. These commentators are of the same mentality that it's horrible unless it is happening to me. Most likely they are the same people that will vote against Medicare for all until they go bankrupt. The hypocrisy of the American electorate will never cease to amaze me, pure emotion never a long term view.
23
Mitral clips aren’t new. They can improve functional status in severe heart failure. They are already covered by insurance.
1
The previous French study showed that there was not improvement if the patient didn't have the proper medical treatment before and afterwards. In this study however the optimal medical treatment was a precondition and the result was convincing. So it's not only about expensive 'clips' and sophisticated procedures.
5
@José Ramón Herrera. That French study was impartial. This one was paid for by the maker of this device.
Keep in mind, the 30k price tag is for a first generation device. Like all new medical technologies, step 1 = establish safety and efficacy, step 2 = reduce the cost.
4
@Johnny actually step one is sell it, get it implanted. Step two is don’t track outcomes, particularly failures. Read “The Danger Within Us.” Medical devices are more profitable than pharma and nearly completely unregulated.
1
On October 4th I will undergo open heart to repair or replace my mitral valve. If I had the option, I might wait for such a device. But I wouldn't survive that long. And the VA would never pay $30,000 for a device when it is cheaper to pay for the surgery. So, I have no option other than to have my sternum cracked and then suffer months of recovery. Oh well.
6
@326 If I were you, I'd write to my congressional representatives and the president. This being an election year you may get some help. (If they can get some positive publicity from it.)
2
@326 I think the diagnosis for heart valve replacement and the described 'clip' surgery for extreme heart failure are quite different. Ask your doctor... you may be looking at replacement because of a defect in your heart valve, not a valve stretching condition caused by the result of heart enlargement from heart failure. Good luck!
2
@Alan C. Thanks Alan!!!
I share the concerns about high costs and the validity of a maker-funded study. Pardon me if I am missing something, but what about the ethics of random assignment to different treatment groups, especially with a life-threatening condition? Don't patients have to be fully informed about risk/benefit issues and their other treatment options?
2
@Brian These studies are run with layers of ethics panels, and yes, such questions are considered. Patients are informed.
2
Readers! Medical device trials are always sponsored by the company that designed them and wants to get them on the market. This is a required step for a submission of a new medical device not “substantially equivalent” to something already on the market. Trials are notoriously expensive, so it’s not like your going to find independent qualified organizations out there wanting to go to the expense of performing or repeating a trial.
21
Interesting that the comments so far question the cost and the real efficacy of the treatment and not hail it as the latest miracle of modern science.
Are we finally learning our for-profit medical-industrial complex isn't all its cracked up to be?
13
Agree with the comments. Funding bias seems more prevalent. Patients should be informed that the device trial was funded by the company that makes the device. Did the company also fund the researchers for travel and speaking fees? Always suspicious.
10
@MD It is good to be suspicious of who is funding the project. Great catch!
A subtle but important point with this clinical trial is that "death" was a secondary endpoint. It was not a primary endpoint because the sponsors of the trial insisted that "hospitalizations" be a primary endpoint to cater to the needs of the insurance companies who in reality approve all procedures and medications these days. So, managed care dictated the clinical trial design -- evidence of the insurance industry's emphasis on saving dollars vs. extending/ saving lives.
12
@Brant Mittler, MD JD
Fewer hospitalizations are also about patients' quality of life. Plus, at least here, there were fewer hospitalizations AND significantly fewer deaths.
3
How about doing a study that is independently run, with no influence from Abbott? Then there is the issue of revenues to be made by the hospital, which could definitely be seen as a conflict, and which would therefore skew the numbers here. These are 2 problems I see with this study, right from the get-go. The cost of the procedure should give all of us pause, at least. This is part of the problem with some new medical advances, and it could be viewed as one contributing factor to the prohibitively high cost of health care. A closer look at the numbers here suggests that results were not so overwhelming. If patients with CHF are not getting optimal medical care maybe we should be asking why before we sink so much $$ into training physicians and purchase of highly specialized hospital equipment. This is my opinion as a retired OR nurse who has seen firsthand the cost of introducing new and highly specialized technologies in the hospital, some of which, in hindsight, are not so successful in the long run.
28
I agree it would be ideal in a perfect world to have completely independent studies of medical devices and new drugs. However, who would pay for this study if not Abbott? How would they convince hospitals to participate in the study without offering them money?
5
@Kristin
That perfect world exist. It is in England, Canada, and France. You remember France from the article where the same study failed to show benefit for the patient. We vote our selves into the worst healthcare in the developed world every chance we get. Enjoy the small government and deregulation we keep voting for. Relegation of your healthcare to profit driven, multinational corporations is killing us.
1
@Dr TLS
If you click on the link to the French study NEJM article, you will see it was also partially funded by Abbott. The UK, Canada, and France may provide better healthcare to their citizens, but they all participate in medical device and drug studies sponsored by big pharma companies like Abbott. Their socialized healthcare systems are not set up to fund the large randomized clinical trials required to evaluate the efficacy of new treatments like this. At the moment, the main entities worldwide with the capacity for that are the pharma companies.
OUR COUSIN by marriage, who was a pediatrician, died at 49 from problems with her heart valves. She left behind her husband, our cousin and their three children. Reading this article I'm sure that her immediate family along with extended family and friends, wish that the surgery and device had been available, as she might have had extra years of life. She had been treated for Hodgkins disease as a teenager, which had affected her heart. It's too late for her, but the valve clip will be a great boon to many others. The time will come when doctors will recommend the surgery prior to the onset of severe heart failure, thereby resulting in even more positive outcomes and greater longevity. The devices are very cost effective, as long term care in a skilled nursing facility is extremely expensive. Ultimately, great economy and a decrease in the effects of heart disease will be a great benefit to humanity worldwide.
9
I am concerned that the NYT article suggests that the procedure may be applicable to everybody with severe heart failure, when it is in truth applicable to only the subset with mitral regurgitation.
Paul Skudder MD.
41
@Paul
I had mitral valve repair five years ago in Atlanta via the "Da Vinci" robot and a device mfg by Medtronic. I still suffer from shortness of breath and fatigue. Does the prior surgery preclude possible surgery using the "MitraClip"?
1
Dr Skudder makes an important point. Heart failure is a big problem, but only a fraction of these people will have mitral reflux.
1
So now Mitral Clips will replace stents as the profit maker of choice. I believe I would like to see a bigger study funded by someone other than Abbott.
23
$30,000 just for a tiny clip? And that doesn’t include the interventionists fees or hospital costs. Then you still have an enlarged heart. Does it increase ejection fraction, decrease edema, improve breathing and quality of life. CHF is a massive cost problem for our health care system, the condition has a high readmission rate with ever increasing morbidity. But I smell a rat. Our country built hundreds of CATH labs, trained thousands of interventional cardiologists. I hope I’m wrong, but this feels like another money making venture without it being a cure.
19
On average, treated patients maintained their level of heart dysfunction while control patients saw further enlargement.
1
Mention of what Abbott is allowed to charge for the device gives pause. The 'Huge Advance' in the title could refer mostly to Abbott, when one connects the dots. Of course it paid for the study. Revolutionary yes, but at what cost? Cheaper than surgery perhaps, but allowing the sky to be the pharmaceutical companies' limit never ceases to amaze.
10
@Monica Mary I don't think it is uncommon for a developer to fund studies. I understand the optics on this but in this article it quotes academic peers as saying that the study and its parameters and metrics were impeccable.
In a future study someone else will have to corporate the findings but in the mean time it seems humane to allow the procedure to be approved in an effort to improve the lives of those impacted by these debilitating illness/disease.
7
Medical bills are a leading cause of bankruptcy in the U.S. No wonder - this tiny clip alone is $30,000. I get that companies have to pay for their R&D, but prices are out of control.
27
Device and pharmaceutical companies have their R&D costs and profit targets.
Abbott's price for MitraClip it not "out of control".... Rather, as with many medical devices, the high price in the U.S. and lower prices in other countries is based on what Abbott believes each market will bear and pay for its techologically-advanced device.
One important factor in determining the $30,000 "sticker price" is what payors (insureres, Medicare) are currently "billed" by hospitals for the "open-heart" Mitral Value Repair procedures this percutaneous procedure substitutes.
Sure $30,000 is a lot of dough, but potentially a bargain given the drastically shorter hospitalization and the cost of the materials and O.R. time and SICU days consumed in the open-heart procedure.
And that is before one considers the apparent savings attributable to the documented reduction of post-procedure hospitalizations for heart failure exacerbations.
And THAT is before one considers the gains in Quality of Life, to which we cannot easy attribute a monetary value, but to which those who had severe symptoms of MR is "priceless".
The risk to society (and patients) after the publication of findings like today's NEJM study occurs when expensive innovations are overzealously employed by cardiologists who are not adequately trained and experienced or when patients who do not truly meet the rigorous inclusion criteria to which study patients were subjected are induced to receive the treatment.
7
I will believe this when the study is performed in a way where the patients and providers are blinded to the treatment. Open label studies such as this are encouraging, but the ORBITA trial showed that bias needs to be minimized as much as possible in device studies such as this.
12
@MIndful
It's a very delicate walk, ethically, to perform single-blinded sham surgery (where patient gets cut open but does not get the new device). It's nearly impossible for the surgeons to be "blinded" -- to not know whether they are doing a real surgery or a sham surgery (how would that work??).
Yes, the gold standard for determining whether a surgical intervention is effective is when the patient and follow-up care practitioners don't know if the patient got the new device or some placebo (e.g., just cut open and put back together). However, such studies are difficult to administer, hard to sign up volunteers, and add even more costs. Statistical comparison studies following the initial efficacy studies make more sense.
8
For this therapy, that is impossible to have a double blind study unless every patient underwent sham procedure and none had subsequent echocardiogram.
2
What does it mean that Columbia gets royalties from sale of the device?
15
That typically means that the technology was invented at the institution, and a company (here I believe Abott) licensee it and actually commercialized it. The article could have been a little clearer on that point
7
@St f If Columbia is like every other university, any patents granted to researchers are shared with the university. The logic behind that is the facilities, staffing, and money used in the research of the device, procedure, or drug came from the university itself.
That is why you often see professors setting up completely separate businesses and labs to do their research independent of the university system. That way there is no revenue sharing.
10