When Media Doctors Play Doctor

After George W. Bush's recent controvertial stent placement, news organizations were hot to jump on the media buzz created by a former President's health issues. Perhaps the funniest moment of all came from Fox News' proported medical "A-team" member, Marc Siegel, MD.

Dr. Siegel is an internist by trade, and when internists are handed a cardiac stent to open on TV, the ensuing moments were something to behold:



The special moments begin a 2 minutes into the video where Dr. Siegel attempts to open the stent packaging (even resorting to using his teeth 22 seconds later). After failing, he hands the package back to the anchorwoman who hands the challenging packaging to her TV crew to open.

Once the package contents are returned to Dr. Siegel, he remains baffled and displays the stents flush port to the TV audience as the stent.

Sorry, but it rarely gets better than this on TV...

-Wes

How To Simplify Consents

He arrived at the emergency room diaphoretic, hypotensive, and with substernal chest pressure.  The patient was brought immediately to an emergency room care area and a stat EKG disclosed classic ST segment elevation in the inferior leads.  The cath lab team was immediately summoned as the ER team worked to stabilize the patient.  Within minutes, the attending cardiologist was on the scene, reviewed the EKG, examined the patient, and explained to the hoardes of family members with the patient what was taking place.  In the interest of being expeditious with his consent process as the team was arriving to take the patient to the cath lab, the attending said:

"There is a 1% risk that anything bad that you can think of could happen with this procedure.  If you'd like me to detail those things, I can."

The patient didn't want to hear, and off to the cath lab they went to open the patient's occluded right coronary artery to great relief of the patient and family.

Later, in follow-up, the attending cardiologist was making rounds and asked the patient his occupation.

"I'm a malpractice attorney."

Smiling, the cardiologist immediately asked, "How was my consent?"

"Perfect.  Absolutely perfect."

-Wes

"This Is The Way It's Done"

Stephen L Snyder, attorney for Dr. Mark Midei, comments on the US Senate's Finance Committee's staff report (4.4 MB pdf file) of stent usage at St. Joseph Medical Center in Towson, Maryland:


-Wes

Where Were the Techs and Nurses?

Medicine is a team sport. No single doctor can do what they do without tons of help from nurses, technicians, clerical staff, and yes, even adminstrators.

So it was with considerable surprise that I saw this piece from the Baltimore Sun:

"An internal review, begun last May at the behest of federal investigators and in response to a patient complaint, has turned up 369 patients with stents that appear to have been implanted in their arteries unnecessarily, CEO Jeffrey K. Norman said in an interview yesterday. Patients began receiving letters alerting them to the finding early last month, and more notifications are expected as the review continues.

"We take our interaction and the care of our patients with the utmost seriousness, and so we wanted to alert patients and their physicians to what we found," said Norman.

In several cases reviewed by The Baltimore Sun, patients who received coronary stents at St. Joseph - purportedly to open a clogged artery to correct a severe blockage - have since learned they had only minor blockage, if any. One 69-year-old man was told his artery had a 95 percent blockage, yet the new review suggests something closer to 10 percent, which is considered insignificant. A 55-year-old woman who agreed to receive a stent after being told she had a 90 percent blockage has since learned she had virtually no problem and that she never suffered from the heart diagnosis that has consumed her life for the past 18 months."

As bad as this might seem, realize that during angiogram procedures there are technicians and nurses that are responsible for prepping the room, administering meds and monitoring the patient. No physician works in isolation and everyone can see the monitors. Face it, the difference between a 95% blockage and a 10% blockage in a coronary artery is not subtle.

So, yes, the doctor's actions in this case are unconscionable and should be met with swift action, but when something like this is allowed to occur it's much more than the fault of a single doctor.

This was a system problem.

-Wes

Syntax Trial Online Chat by Dr. Ted Feldman

Dr. Ted Feldman, Director of Interventional Cardiology at NorthShore University HealthSystem and one of the lead authors of the recently published Syntax trial comparing peripheral coronary interventions (PCI) head-to-head with coronary artery bypass grafting surgery (CABG), held an online chat today at noon to discuss the much ballyhooed results published yesterday online before print in the New England Journal of Medicine. The online chat provides a bit of the interventionalist's perspective on the results.

Although the chat has ended, you can view the transcript here by typing in your name and using the password "DES" (clever, eh?).

-Wes

How to Scare a Reporter

Just show him an angioplasty with a little Bezold-Jarisch reflex and a brief bout of ventricular fibrillation then watch him bail into the control room.

Heh.

-Wes

PS: Note the size of the clot they aspirated from the artery. (Yes, Mr. President, it doesn't take much to bring a young smoker to his knees.)

Medtronic's Endeavor Stent Finally Approved

As expected, Medtronic's Endeavor drug-eluting stent was approved by the FDA today.

Looks like more competition has just arrived for this crowded space.

-Wes

More Direct-to-Consumer Insanity

Now it's Johnson and Johnson's turn: starting on Thanksgiving Day, coronary stent (specifically Cypher stent) advertisements began airing on television directly to "consumers," our patients, promoting the ability of stents to "prop up your life" that has been "narrowed" by coronary blockages. "Life wide open" is the tag line.

It's so catchy. As though our patients can go down to the corner store and pick one of these up for their heart. I guess J&J feels patients can discern when a drug-eluting stent is preferred over a bare metal stent, or better yet: when a stent is appropriate and when it is not. Why didn't their ad mention that other non-invasive options might be more appropriate before stenting in some circumstances?

Well, it's simple. The best medical care isn't important to J&J. What is important is that J&J sells more stents. To that end, what's really important to J&J is that patients ask their doctors why their life isn't "wide open" and full throttle yet. As if we don't have better things to discuss.

But I guess J&J figures our patients' wallets are wide open, given the cost of such advertising, especially in prime-time TV slots. This advertising, by the way, is in addition to an already re-worked website and other print media that has appeared in major newspapers.

And J&J seems to be taking a path that is in direct conflict with their own credo, their guiding mission statement, that has hung on their walls for over 60 years:

"We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services. In meeting their needs everything we do must be of high quality. We must constantly strive to reduce our costs in order to maintain reasonable prices."

And where's the FDA who promised to monitor such advertising to our patient "consumers?"

Oh, I forgot - they're enjoying "monitoring" the commercials with a beer in their hand in front of the TV.

-Wes

Image credit.

So Much for COURAGE

If a feel-good PR piece for interventional cardiologists, Adolph Bachman, the first angioplasty recipient, was introduced at the Transcatheter Therapeutics Conference (TCT) and told his story about insisting he get another stent, despite what the COURAGE trial suggested:

X-rays showed a new blockage near the site that had been cleared in 1977. Dr. Meier said he told Mr. Bachman it was not serious enough to warrant even a low-risk procedure like angioplasty.

After Mr. Bachman continued to complain, Dr. Meier inserted a catheter into the artery to perform a diagnostic test that showed strong blood flow through the narrowing. The test is one that some doctors think should be more widely used to avoid unnecessary stenting, but Dr. Meier is among the majority who believe it is generally not worth the additional time and cost.

Despite the results, Mr. Bachman insisted on not only getting the angioplasty but on getting a stent inserted. Two months later, he was back at the hospital in need of a procedure to clear a new blockage in the bare-metal stent.

Now we see who's driving the stenting bus...

-Wes

Stent Shrinkage

I heard a new term related to coronary stents today: "shrinkage." Unlike the manly "shrinkage" of the Seinfeld show, it seems new polymer stents can also suffer from "shrinkage:"

(TheHeart.org) Dr Patrick Serruys (Thoraxcenter, Rotterdam, the Netherlands) presented results of the ABSORB trial during a late-breaking session at the American College of Cardiology 2007 Scientific Sessions today. In the trial, 26 patients received the new stent—which, it is hoped, will completely dissolve after 12 to 18 months—and there was no evidence of stent thrombosis after six months, together with a low rate (3.3%) of ischemia-driven major adverse cardiac events (MACE).

But late loss and restenosis were greater with the bioabsorbable stent than with current drug-eluting stents, and Serruys said the 15% shrinkage seen with the new stent may be to blame for these findings. He is hoping that the modification of the stent design—due to be completed by the end of the summer—will solve this problem. "This may be the beginning of a new era. I'm convinced of it," he commented.

However, chair of the late-breaking press conference, Dr Spencer King (Emory University School of Medicine, Atlanta, GA), was more circumspect: "Our early experience with polymer stents was terrible in experiments in pigs. This trial is in only 30 patients, with short follow-up. However, on the plus side, we didn't see any inflammation. Time will tell."

My guess? Shrinkage has already killed this current generation of bioabsorbable stent, but a second-generation polymer stent is already in the works...

-Wes

FDA to Review Off-Label Use of Biliary Stents

Showing an ever-growing presence in the post-market medical device arena, it now appears that the FDA is going after biliary stent manufacturers to review “off-label” use of these devices to prop open larger blood vessels.

Tiny bile-duct scaffolds, known formally as biliary stents, are supposed to prop open the tubes that carry digestive fluids to the intestines, as opposed to blood-pumping arteries, which are the province of stents approved for vascular uses, including drug-coated coronary stents used near the heart.

But since biliary stents are available in much larger sizes than their vascular cousins, doctors commonly use them to prop open large arteries, such as those leading to the legs and kidneys. "Our go-to stent for disease in the legs are biliary stents," said Dr. Gary L. Schaer, the director of the cardiac-catheterization laboratory at Rush Hospital in Chicago. A September 2006 article by an FDA scientist also concluded that "virtually all" kidney-artery operations used stents not approved for that purpose.

Some industry sources estimate that as much as 90% of biliary stents are sold to catheterization laboratories and used off-label in arteries. On-label sales of biliary stents amounted to about $38 million last year, according to Millennium Research Group. Those numbers don't include off-label use in arteries.

Government intervention for patient safety is critically important, especially when the use of drugs or devices shows significant harm to patients. But government intervention in health care also may threaten the very way medicine is practiced today.

In the case of biliary stents, doctors devised a creative solution to a difficult clinical conundrum (resolving blockage in a large artery when no FDA-approved tool exists) that has helped many patients avoid significant complications from major surgery. When these doctors compared the results of a minimally-invasive approach to the difficulties their patients had with major open surgical procedures like infection/wound healing, etc, they were hooked. The biliary stent companies responded to the demand in kind.

The situation is analogous to the early days of catheter ablation. As an electrophysiologist, I can vividly recall the conundrum the FDA was placed in when catheter ablation burst onto the scene of cardiac arrhythmia management. Doctors recognized then that significant risks existed with open heart surgery for surgical arrhythmia management and felt (correctly) that the morbidity and mortality of off-label catheters for catheter ablation was safer for their patients.

But now, if the FDA restricts the sale of these stents to patients when no properly-labeled alternative exists on the market, will physicians be forced to change their practice and take a giant leap backward in patient care management in the interest of proper FDA labeling practices?

And why stop with stent manufacturers? Is the FDA going to extend their reach still further? What about off-label drug use?

Physicians have a long history of off-label drug use. Take the drug amiodarone, for instance. Amiodarone is the most commonly prescribed (and effective) antiarrhythmic medication prescribed for atrial fibrillation, an irregular heart rhythm of the upper heart chambers, but is not approved for this indication. Could the FDA force manufacturers to go back to the drawing board before sales for such drugs are permitted for "off-label" indications?

This would set an ominous new precedent for physicians and their patients. It would also set an ominous new precedent for the medical device and pharmaceutical industry. Worse still, it would set a new precedent for the legal industry to proceed to litigate every off-label complication that occurs to a patient - be it drug or device.

-Wes

CMS Could Retrict Payment for Drug-Eluting Stents

The Center of Medicare and Medicaid Services (CMS) is considering limiting reimbursement strategy for drug-eluting stents that are placed "off-label," like diabetics and those who having heart attacks. According to the Wall Street Journal this AM:

..."the Centers for Medicare & Medicaid Services, or CMS, says it is considering reopening its decision about how broadly to cover the stents. An agency spokesman said such a process, known as a National Coverage Determination, could result in restricting coverage of the stents to FDA-approved uses, keeping coverage the same, or something in between.

This could spell more bad news for Johnson and Johnson and Boston Scientific if further cuts in reimbursement for drug-eluting stents are implemented.

Almost on cue, data from a single-center observational study were published earlier this week in the American Journal of Cardiology that suggested that drug-eluting stents might be superior to bare metal stents in such "off-label" patients:

Abstract: In clinical trials of highly selected patients, drug-eluting stents (DESs) decreased restenosis but not the rate of acute myocardial infarction (AMI) or death. Whether DES use has an affect on the rate of AMI or death in unselected patients is uncertain. Bare metal stents (BMSs) were placed in 1,164 consecutive patients in the year before the introduction of DESs. DESs were subsequently placed in 1,285 consecutive comparable patients at Wake Forest Baptist Medical Center. Early and late clinical outcomes were compared. Propensity score analysis was used to adjust outcomes for baseline differences. Patient and procedural characteristics of the 2 groups were similar, with an overall incidence of 72% for acute coronary syndromes (p = NS). At 9 months, target vessel revascularization (2.8% vs 8.6%, p <0.001), AMI (3.7% vs 4.7%, p = 0.257), and death (4.9% vs 7.1%, p = 0.030) were lower in the DES group than in the BMS group. Propensity score-adjusted Cox proportional hazard ratios for DES versus BMS at 9 months were 0.71 (95% confidence interval 0.42 to 1.19) for AMI, 0.56 (95% confidence interval 0.36 to 0.87) for death, and 0.60 (95% confidence interval 0.42 to 0.86) for the combined end point of AMI or death. In conclusion, in this single-center observational study, use of DESs in consecutive unselected patients, most of whom would not have been eligible for inclusion in the randomized trials of DES versus BMS, was associated with lower AMI and death rates than in a comparable group of patients treated with BMSs in mid-term (9-month) follow-up.

This study was sponsored by Johnson and Johnson. What the effect on long-term clopidogrel therapy, recently recommended to prevent the late in-stent thrombosis of drug-eluting stents has on these "off-label" patients, especially after nine months (when in-stent thrombosis is seen), remains untested. Look for significant positioning by these companies to continue the status quo.

-Wes

References: Robert J. Applegate, Matthew T. Sacrinty, Michael A. Kutcher, Talal T. Baki, Sanjay K. Gandhi, Renato M. Santos and William C. Little, Comparison of Drug-Eluting Versus Bare Metal Stents on Later Frequency of Acute Myocardial Infarction and Death, The American Journal of Cardiology, Volume 99, Issue 3, 1 February 2007, Pages 333-338.

Keith Winstein, "Agency Reviews Stent Coverage," Wall Street Journal (Subscription), 6 February 2007, Page D4.

Another Biodegradable Stent Debuts

And just when the cardiovascular surgeons thought they might wrestle back the coronary revascularization business, a new completely bioabsorbable coronary stent released its first early clinical results today. This stent is produced by Bioabsorbable Vascular Solutions, Inc. (BVS), a Guidant (now Boston Scientific spun off to Abbott Vascular during the earlier Guidant acquisition by Boston Scientific):

The new BVS stent is made of a polymer that dissolves into lactic acid over two to three years. Lactic acid is a naturally occurring substance in the body, produced after exercise. It breaks down into carbon dioxide and water, and is absorbed by the body.

Unlike earlier bioabsorbable coatings over a bare metal stent, like the earlier Biomatrix stent, no bare metal exists in this stent. Of note, the stent also contains everolimus, and elutes this drug over an estimated 120 days. These patients are part of the ABSORB clinical trial enrolling up to 60 patients in Belgium, Australia, Denmark, France, the Netherlands, New Zealand, and Poland. While the initial results seem promising, there are a few caveats worth mentioning:

• These stents have no long-term track record and have not yet begun trials in the US, to my knowledge, but the international experience will form a basis to begin the first US trials, if successful.


• The stents will have an initial inflammatory reaction after implantation since the polymer is a foreign body. As such it is still subject to restenosis, though the everolimus should help reduce this inflammatory response.


• It should have better imaging in MRI scans and CT scans since the polymer will not cause the reflectance artifact like metal stents.


• While the absorbable nature of the stent is intriguing, the mechanism of late-stent thrombosis is unknown, so long-term studies on anti-platelet agents will still be needed, especially since the stent is drug-eluting for only 120 days of its 2-3 year existence in the coronary artery. It's just too early to claim that these new stents will reduce in-stent late thrombosis risk yet.

Nonetheless, it is refreshing to see some new news on the coronary stent front that might make the debate between bare- and drug-eluting metal stents a mute one.

-Wes

Off Label Stents Equals One Year Aspirin and Plavix

From MedPageToday:

The FDA's drug-eluting stent safety panel recommended today that the labels of Cypher (sirolimus-eluting) and Taxus (paclitaxel-eluting) stents be changed to include a warning that off-label use of the devices may carry an increased risk of stent thrombosis, myocardial infarction, and death. The panel also called for the label to carry a recommendation for 12-months of dual antiplatelet therapy with aspirin and Plavix (clopidogrel) when drug-eluting stents are used off-label.

This is a reasonable recommendation based on the paucity of data that exists to date. Look for new package inserts and for cardiologists contining their current treatments. Once formal recommendations are issued, some big trials like the SYNTAX trial, which compares stent therapy to cardiac bypass surgery for three-vessel and left main coronary disease, might need to change their consent forms and duration of clopidogrel (Plavix) therapy in the stent-treated arm.

For patients with drug-eluting stents, be sure to check with your doctor if additional Plavix and aspirin therapy are warranted in your case. Here is the FDA's "on-label" use for Boston Scientific's TAXUS stent (pdf file):

The TAXUS Express 2 Paclitaxel-Etuting Coronary Stent System is indicated for improving luminal diameter for the treatment of de novo lesions < 28mm in length in native coronary arteries > 2.5 to < 3.75 mm in diameter.

And for Cordis' Cypher stent (pdf file):

The CYPHER® Stent is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length < 30 mm in native coronary arteries with a reference vessel diameter of > 2.5 to < 3.5 mm.

Your doctor can help you sort this out and most patients will be just fine, but some may need slightly longer anti-platelet therapy with aspirin and clopidogrel (Plavix).

-Wes

FDA and Stents: Bet on Aspirin and Plavix

There seems to be a lot of gnashing of teeth about what to recommend for people who have received drug-eluting stents. Should patients continue the anti-platelet (and hence, anti-clotting) drugs, aspirin and clopidogrel (Plavix) indefinitely? Or should these drugs be stopped sometime after one year?

A big, manufacturer-friendly, FDA “advisory panel” will convene on Thursday and Friday in Gaithersburg, Maryland to discuss this topic and review meta-analyses, anecdotal-isms and retrospective registries. No one will have any prospective, randomized data over many years comparing the risk of clot-formation in stents compared to the risk of bleeding from Plavix and aspirin.

It is important to remember that restenosis of bare metal (non- drug-eluting) stents due to the growth of scar-like tissue (called "neointimal hyperplasia") inside the bare stent was a real problem in patients before drug-eluting stents hit the market. Smaller diameter stents were most likely to develop this complication compared to larger diameter stents. But after drug-eluting stents burst into the market, this problem became much less prevalent. Cardiologists stopped seeing the "frequent fliers" for repeat stenting and no longer performed the more complicated brachytherapy (radiation) to prevent restenosis. Cardiologists aren't stupid: they liked this feature of drug eluting stents.

Unfortunately, over the course of time, it was eventually discovered that drug-eluting stents occassionally clot shortly after the Plavix medication was discontinued. This didn't happen all the time, mind you. It happened about 5 percent of the time. But unlike restenosis of bare metal stents that occurs slowly, the clotting seen after stopping Plavix in a drug-eluting stent is often an abrupt, sudden event leading to much larger heart muscle damage.

It became clear that taken together, Plavix and aspirin are important deterrents to the formation of blood clots in stents. But the long-term risks of life-long Plavix, especially it’s risk for developing later bleeding complications, are unknown. And Plavix is expensive. Many cannot afford the drug and Medicare doesn’t cover the drug unless individuals carry a supplemental drug benefit.

The problem now, in my view, is that there are lots and lots of drug-eluting stents in patients already out there. Stents, once deployed, can’t be removed. And we cannot abandon our patients. So the clot-preventing drugs aspirin and Plavix must be continued for at least a year, or better yet, indefinitely unless the risks of bleeding are excessive.

Also, it would not be surprising if the FDA recommended that larger-diameter stents be bare metal, since restenosis risk is lower in these larger-diameter stents. And look for the advisory panel, in the interest of "safety" to require new stents (and new competitors to the panel's companies they represent) to have to submit "more data," delaying approval of the other companies' stents.

Finally, I would not be surprised if the FDA recommends that a registry be developed to track complications (the FDA loves registries: just look at the recent defibrillator recall fiasco). This might permit a later development of data-based guidelines based on probabilities. One such decision support tool that uses retrospective data has recently been deployed in Kansas.

For the non-cardiologist, issues on how to handle non-cardiovascular surgery in patients on Plavix and aspirin still need to be better defined, but I doubt the panel can cover all of this territory in the short two days ahead.

For now, though, a lot of this will be “flying without instruments.” And the weather is still partly cloudy…

-Wes

Bioabsorbable Stent May Have Promise

From the Chicago Tribune:

The absorbable stent is made of polylactic acid, which is used in other medical products such as sutures used to close wounds after surgery and also absorb into the body, researchers say. It is coated with the same drug that Abbott uses on its drug-coated metal stent, known as Xience. The stent has been approved in Europe and Abbott will submit it to U.S. regulators next year for approval in 2008.

But 30 patients so far (and 30 days of follow-up) in the US is still a small number.

Abbott's study so far involves just 30 patients who have had the absorbable stents implanted for just 30 days, but Abbott and researchers involved with the product said it seems to be safe and shows no sign of clotting or other harmful side effects so early in the clinical trial process.

Ah, the power of marketing. I just wish companies, in their rush to have early results for big (money) meetings like the TCT meeting in Washington this week, would refrain from such press releases until longer follow-up and real safety data are available. It reveals the subterranian motives of our pharmaceutical industry: stock prices are more important than patient well-being.

-Wes

Infection: A Cause of Cardiac Stent Thrombosis?

If we know that sterile technique is important to reduce infection in the cardiac electrophysiology laboratory when implanting foreign bodies like pacemakers and defibrillators, why do interventional cardiologists feel the risks of implanting foreign bodies like bare-metal or drug-eluting stents are less likely to become infected?

Now let me be clear. I have no data on this subject. Certainly when fevers develop after an angioplasty we might consider stent infection in the differential diagnosis of post-stenting fever. But could subclinical infection without fever be a cause of stent thrombosis? I know that the practice of not wearing surgical masks and hats is common in many cath labs around the country. Yesterday AM in the New York Times we saw yet another cardiologist without a hat or mask while performing an interventional cardiac procedure. Note that the technician assisting the doctor is wearing the mask and hat (and protective goggles).

But take a look at this high-speed picture of the average sneeze:


What kind of critters are spread widely in the lab setting when this occurs? Speech spreads bacteria in a similar fashion.

This is a particularly perplexing problem because localized stent infection just might (and I emphasize the word "might") be a cause of in-stent thrombosis. Since in-stent thrombosis and sudden late clotting of stents has recently come to the forefront of cardiologists' conciousness, as well as the conciousness of medical device companies like Boston Scientific, Medtronic and Cordis, why are we not having this discussion? Admittedly this conjecture is extremely difficult to prove or disprove. Stents are small and fixed into critical blood vessels supplying the heart muscle. Systemic symptoms may NOT be seen because of the tiny size of the devices. (When was the last time you had a fever when a splinter was caught in your foot?) Removing a stent for "culture" is impossible once the device is deployed in the coronary artery (short of open heart surgery and bypass). But fastidious organisms that grow slowly are well-described in the infectious disease and cardiology literature.

Before we start blaming drug-eluting stents as the problem, perhaps we ought to examine our own practices more carefully. Could we be part of the recently-discovered problem with in-stent thrombosis?

Hey, this might be a cool project....

-Wes