Posts Tagged ‘surgery versus stenting’

It’s becoming a cardiologist’s worst nightmare: after years of minimal outside oversight, with multiple physicians operating on the fringes of medical legitimacy (stenting the left main, three vessel stenting, overstenting vulnerable populations like diabetics*) new legal and medical scrutiny is being placed on cardiologists and cath labs in the wake of widespread reports of overstenting. (Overstenting is the use of medical devices called stents when surgery, medications or other modalities are called for.)

Overstenting is a combination of two different problems:

1. the placing of a stent in an artery without a severe blockage (aka unnecessary stenting) – this places the patient at risk for cardiac cath lab, and stent complications unnecessarily in patients who DON’T NEED IT. One of the reasons this practice is so prevalent is that patients don’t understand that this is a dangerous practice – this isn’t a preventative measure like a seatbelt or a vaccine.. Not all disease progresses at the same rate, and just because someone has a fifty percent narrowing – it MAY NEVER WORSEN.. But fifty percent sounds scary, doesn’t it? So patients never realize that they’ve been had..

Maybe doctors get away with it much of the time, but what about the patients with acute stent thrombosis – where a blood clot lodges in the stent (the stent is a piece of metal, a foreign body that irritates the walls of the artery, causing increased risk of clot formation.)

Now this patient with the clot – is going to have a heart attack, and potentially even die from this.. Because of a treatment they didn’t even need..

2. Now the second class of patients – these patients are the sick patients.. These people go to the cath lab – and they have lots of blockages and severe blockages (75%, 90%, 100% blocked) in more than one place. These people should have bypass surgery – AND WE KNOW THIS. We know this from thousands and thousands of patients followed over time, in multiple studies.. Survival expectancy in patients with multi-vessel coronary artery disease (CAD) is a MEAN of 17 years.. There isn’t a stent on the planet that has lasted or will last seventeen years. So placing a stent (or lots of stents) in these patients is VERY dangerous – these people will clog up their stents – maybe have heart attacks (damaging their heart muscle); causing congestive heart failure or even death.

ALSO, all those stents make later heart surgery more difficult – imagine the surgeon trying to work around all these little metal coils to find a place to attach a bypass graft. Not pretty.

* Diabetes are considered a vulnerable population because we know that stents don’t last in these patients.

So, now that I’ve had my say – I’m re-posting this article from The Heart.org which is a subscription, paid site, so the rest of you can read it for yourselves.. Just a note to readers: PCI means angioplasty stent placement (PerCutaneous Intervention)

Cardio groups ask Maryland legislature to consider upping cath-lab oversight in wake of over-stenting debacle
March 2, 2011 | Reed Miller
Annapolis, MD – Two major cardiovascular professional societies are taking the unusual step of asking a state government for more oversight of their practice to restore what they perceive to be sinking public confidence in cardiovascular interventionists.

Speaking on behalf of the Society for Cardiovascular Angiography and Interventions (SCAI), Dr Mark Turco (Washington Adventist Hospital, Takoma Park, MD) told heartwire that after the allegations surfaced against interventionalist Dr Mark Midei (St Joseph Medical Center, Towson, MD) and Dr John R McClean (Peninsula Regional Medical Center, Salisbury, MD) many patients began telling their physicians that they did not have confidence in stents.

“Interventional cardiology is a big user of health care dollars and we’re concerned that the public has a perception that we are often moved to treat patients on the basis of relationships with [drug and device] vendors,” Turco said. Turco is also president-elect of the American College of Cardiology’s Maryland Chapter.

Current ACC Maryland Chapter President Dr Sam Goldberg (Bethesda, MD) told heartwire “when the news broke about the inappropriate use of stenting at St Joe’s hospital in 2009 and 2010, I felt that we needed to be proactive in dealing with this issue, so we started reviewing what our own physicians do and what kind of oversight we have and . . . I felt we needed some greater oversight.”

Today, Goldberg and Turco testified before committees of the Maryland General Assembly to pass the Maryland Cardiovascular Patient Safety Act (Senate Bill 742, House Bill 690). They met with the House of Delegates Health and Government Operations Committee a few hours after addressing the Senate Finance Health Subcommittee.

“Rarely do [doctors] develop our own legislation,” Turco testified before both committees. “And rarely do we advocate for more oversight! The fact that we have done both shows how strongly we feel about the need for this legislation.”

Rarely do [doctors] develop our own legislation. And rarely do we advocate for more oversight! The bills, if passed into a law, would launch three new initiatives. It would mandate that the Maryland Health Services Cost Review Commission use data in the Maryland Health Care Commission’s CATH-PCI and ACTION registries, along with administrative data, in order to get the most accurate picture of cath lab practices.

The bills also call for the creation of a system of independent peer review and external oversight that would audit a cath lab’s practices to ensure that they are consistent with the current professional guidelines and in patients’ best interest. “Looking into the [current] in-hospital peer review process, which is a legally protective process, that is done within the hospital . . . I saw that there were very few guidelines about how it’s done and it’s an inherently biased process because you have cardiologists who all know each other reviewing each other, and some are business partners and colleagues, and it’s very difficult for them to be very critical of some things and I felt we needed some greater oversight,” Goldberg said.

The bills also calls for all cath labs in the state of Maryland to be accredited by a nationally recognized accreditation body such as the fledgling Accreditation for Cardiovascular Excellence (ACE) set up by SCAI. Mary Heisler, Executive Director of ACE, also testified before both legislative committees. She said that her group could accredit a Maryland hospital to run a cath lab for under $25 000 a year. “While we recognize this is a difficult economic time, this will avoid the problems that just cost [St Joseph hospital] $22 million,” she said. “This fee is the equivalent to the reimbursement a hospital receives for approximately two stent procedures.”

Denise Matricciani, the Maryland Hospital Association’s (MHA) Vice President for Government Relations, testified that her organization broadly supports the aims of the bills, but that the MHA does not support mandating accreditation at this time. She pointed out that ACE has not yet performed the kinds of surveys of appropriateness envisioned by the bills’ supporters and that there are no data yet to support the effectiveness of its process. Also, MHA is not convinced that an accreditation process would do much to stop inappropriate procedures.

“Accreditation may have merit in the future, we just don’t believe that mandatory accreditation is appropriate at this juncture,” she told the house committee. She also refuted the insinuation of the ACC representatives that MHA’s opposition is based only on cost concerns.

Matricciani outlined some of the efforts her group is undertaking to root out waste and abuse and improve public confidence in cath labs. For example, MHA recently created a Necessary Care Work Group, with medical directors and quality leaders, to study and make recommendations to the Department of Health and Mental Hygiene (DHMH) and the legislature on issues related to inappropriate percutaneous coronary interventions and other medical procedures.

The group also created Guidelines to Ensure the Appropriateness of PCI Procedures. “As this body has witnessed over the years, we can do a lot with our members in terms of doing what’s right,” Matricciani told the house committee. “These guidelines strive to ensure patients, the public, and practitioners that stent placements are appropriate and necessary and right for the patient.”

In his testimony before both committees, Turco argued that internal efforts by the hospitals to oversee the cath labs will not be sufficient to prevent problems like those at Peninsula and St Joseph.

“To those who would advocate for the same old system with ‘suggested regulation’ rather than legislation to fix problems, I would ask—can you explain why and how that regulation would be enforced? And I would ask, if it was so easy to just regulate, why has it not been done in the past, and how have we found ourselves in this situation today?”

He continued: “Accreditation will provide needed oversight for hospitals, while removing much of the variability in care from one center to another.” He added that although accreditation of cath labs would be a new requirement and possible burden on hospitals, the hospitals are already accustomed to handle a variety of accreditation processes for other procedures and departments, so preparing for cath lab accreditation would not be overly burdensome.

Turco also told heartwire that he believes that regulation of cath labs and medicine in general is probably only going to increase in the future regardless, so it behooves the hospitals and the physicians to be proactive in proposing an oversight system to legislators instead of waiting for outsiders to impose one on them.

Update: 17 march 2011

Saw this little gem in my cardiology newsletter – which conveniently, I might add, neglects to mention LONG – TERM outcomes, which as my readers know have been definitively proven to be better with cardiac surgery.. (Come on people, play fair.. it’s hard enough for patients out there without all this deceit..)


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