Making "Safe" Stents SaferWords
--The key to making “safe” drug-eluting stents safer--
When it comes to tackling matters of the diseased heart, like clogged arteries, drug-eluting stents have rapidly become standard procedure. After hitting the market in 2003, these medical devices now prop open the arteries of 3 million Americans.
Earlier this month, however, the FDA convened a panel to evaluate their safety. These metal tubes—which ooze tissue-killing chemicals into arteries—do an extraordinary job of fighting the re-clogging associated with conventional stents, but they have also been linked to clotting, a phenomenon that can lead to heart attacks, and even death.
Clotting occurs more readily with drug-eluting stents because chemicals in the stent coating are nonselective; they inhibit the growth of harmful artery-clogging cells, as well as growth of cells that would fight clotting naturally.
Despite ties to clotting, the FDA panel concluded on December 8th that drug-eluting stents are safe, as long as they’re used in conjunction with anti-clotting medication, and in the intended population. But risks still loom; even within this approved group, drug-coated stents are causing quite a stir for a particular set of people—those who undergo noncardiac surgeries shortly after stenting.
“Surgery appears to carry a greater risk for these patients than we saw in patients with bare metal stents,” said Deepak Bhatt, Director of the Interventional Cardiology Fellowship at the Cleveland Clinic in Ohio.
That’s because Plavix—the anti-clotting medication required after drug-eluting stent placement—increases bleeding. And since the risk for bleeding is naturally higher during surgery, patients on Plavix should stop taking it before an operation. Without this medication though, the likelihood of harmful clotting skyrockets.
Herein lies the trade-off for people with drug-eluting stents who undergo surgery: stay on Plavix and bleed, or discontinue it, and clot.
According to Richard Shemin, a cardiac surgeon present on this month’s FDA panel, “the fact of the matter remains that more and more patients are getting drug-eluting stents, so surgeons and anesthesiologists are going to have learn how to take care of [complications in] people who have them.”
This becomes especially apparent in light of studies like one published last month in The Journal of Clinical Anesthesia, which reports that a man who underwent hip surgery seven weeks after receiving a drug-eluting stent experienced a heart attack within 12 hours of his hip procedure, presumably due to the clots that formed as a result of discontinuing Plavix.
“This is a big issue,” said the study’s lead author, Mayo Clinic anesthesiologist Michael Brown. “People outside the cardiology realm don't really appreciate the difference between a conventional bare-metal stent and a drug-eluting one, let alone the problems associated with a drug-eluting stent during an operation.”
The good news for patients with drug-eluting stents is that there are ways for physicians to improve safety in the operating room.
“The most obvious strategy,” said Richard Moore, Vice President of the American Society of Anesthesiologists, “is to postpone surgical procedures during the 6 month window directly after stenting. That’s when the patient is undergoing the most intense anti-clotting therapy.”
If surgery is emergent, however, a preoperative cardiology consultation is the next best approach.
“Communication between the surgical team and the cardiologist who placed the stent is vital,” said Sanjay Kaul, Director of the Vascular Physiology and Thrombosis Research Laboratory at Cedars-Sinai Medical Center in Los Angeles. “The problem now is that too often, these conversations don’t take place.”
Dr. Kaul says that anesthesiologists need to consult cardiologists before stopping Plavix.
“They should confer with the cardiologist to understand why the stent was placed, when it was placed, how big it was, and how long the patient has been on anti-clotting medication.” This information helps determine a patient’s clotting risk. For some, it’s relatively low. For others, it’s higher, and remaining on anti-clotting medication during surgery should be a definite consideration, despite chances of bleeding.
Dr. Moore says that anesthesiologists operating on patients with drug-eluting stents should also avoid techniques that could increase bleeding in areas already sensitized to it by Plavix. Additionally, anesthesiologists should monitor a patient’s cardiac status since any patient with a stent has previously had cardiac disease, which the stent may not have cured.
“Ultimately, drug-eluting stents are still good devices as long as patients who have them are well-managed in a surgical setting,” said Dr. Shemin. “With time and experience, as well as the willingness of specialists to communicate, we’ll know better how to do that.”
.MGW.
When it comes to tackling matters of the diseased heart, like clogged arteries, drug-eluting stents have rapidly become standard procedure. After hitting the market in 2003, these medical devices now prop open the arteries of 3 million Americans.
Earlier this month, however, the FDA convened a panel to evaluate their safety. These metal tubes—which ooze tissue-killing chemicals into arteries—do an extraordinary job of fighting the re-clogging associated with conventional stents, but they have also been linked to clotting, a phenomenon that can lead to heart attacks, and even death.
Clotting occurs more readily with drug-eluting stents because chemicals in the stent coating are nonselective; they inhibit the growth of harmful artery-clogging cells, as well as growth of cells that would fight clotting naturally.
Despite ties to clotting, the FDA panel concluded on December 8th that drug-eluting stents are safe, as long as they’re used in conjunction with anti-clotting medication, and in the intended population. But risks still loom; even within this approved group, drug-coated stents are causing quite a stir for a particular set of people—those who undergo noncardiac surgeries shortly after stenting.
“Surgery appears to carry a greater risk for these patients than we saw in patients with bare metal stents,” said Deepak Bhatt, Director of the Interventional Cardiology Fellowship at the Cleveland Clinic in Ohio.
That’s because Plavix—the anti-clotting medication required after drug-eluting stent placement—increases bleeding. And since the risk for bleeding is naturally higher during surgery, patients on Plavix should stop taking it before an operation. Without this medication though, the likelihood of harmful clotting skyrockets.
Herein lies the trade-off for people with drug-eluting stents who undergo surgery: stay on Plavix and bleed, or discontinue it, and clot.
According to Richard Shemin, a cardiac surgeon present on this month’s FDA panel, “the fact of the matter remains that more and more patients are getting drug-eluting stents, so surgeons and anesthesiologists are going to have learn how to take care of [complications in] people who have them.”
This becomes especially apparent in light of studies like one published last month in The Journal of Clinical Anesthesia, which reports that a man who underwent hip surgery seven weeks after receiving a drug-eluting stent experienced a heart attack within 12 hours of his hip procedure, presumably due to the clots that formed as a result of discontinuing Plavix.
“This is a big issue,” said the study’s lead author, Mayo Clinic anesthesiologist Michael Brown. “People outside the cardiology realm don't really appreciate the difference between a conventional bare-metal stent and a drug-eluting one, let alone the problems associated with a drug-eluting stent during an operation.”
The good news for patients with drug-eluting stents is that there are ways for physicians to improve safety in the operating room.
“The most obvious strategy,” said Richard Moore, Vice President of the American Society of Anesthesiologists, “is to postpone surgical procedures during the 6 month window directly after stenting. That’s when the patient is undergoing the most intense anti-clotting therapy.”
If surgery is emergent, however, a preoperative cardiology consultation is the next best approach.
“Communication between the surgical team and the cardiologist who placed the stent is vital,” said Sanjay Kaul, Director of the Vascular Physiology and Thrombosis Research Laboratory at Cedars-Sinai Medical Center in Los Angeles. “The problem now is that too often, these conversations don’t take place.”
Dr. Kaul says that anesthesiologists need to consult cardiologists before stopping Plavix.
“They should confer with the cardiologist to understand why the stent was placed, when it was placed, how big it was, and how long the patient has been on anti-clotting medication.” This information helps determine a patient’s clotting risk. For some, it’s relatively low. For others, it’s higher, and remaining on anti-clotting medication during surgery should be a definite consideration, despite chances of bleeding.
Dr. Moore says that anesthesiologists operating on patients with drug-eluting stents should also avoid techniques that could increase bleeding in areas already sensitized to it by Plavix. Additionally, anesthesiologists should monitor a patient’s cardiac status since any patient with a stent has previously had cardiac disease, which the stent may not have cured.
“Ultimately, drug-eluting stents are still good devices as long as patients who have them are well-managed in a surgical setting,” said Dr. Shemin. “With time and experience, as well as the willingness of specialists to communicate, we’ll know better how to do that.”
.MGW.
posted by Meagan G at
7:04 AM
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