Arcos De La FronteraWords

-Arcos de La Frontera: Red Puppet in a White City-


[This is an archived piece. I wrote it after a particularly lively trip during my travels in Spain.]

I had never ridden a mule, and the man had no teeth. I think that’s what made it so easy; we were both unsure. But he smiled at me, a visitor, as I mounted that mule, and I thought I could not soon be higher than this—on a mule’s back on a hilltop whose skirts were sheer rock.

This hilltop, a fine point of defense, had drawn Moors to Arcos, but it had not drawn me. I had come to Spain’s most dramatically perched pueblo—a pueblo blanco—because I wanted to walk narrow streets of a town too old to wake up. I wanted to see its cobblestones and its whitewashed homes, and know who lived inside.

This toothless man did not, though I was lucky to meet him. He lived below, where sheer rock plunged to dirt. The dirt, like the hilltop, had tempted the Moors; it was fertile and rich, and I could tell from one green glimpse that it was the dirt’s fruit that had fattened the mule.

He was most certainly fat, and I was uncomfortable. But I smiled despite it, with all of my teeth, and held tight as the man pulled his beast through the streets. In Arcos, the streets are strikingly narrow. Lined with small elegant homes and wrought ironed gates, they are not meant for creatures so fat.

As my feet brushed white plaster, I wondered why nobleman had not wanted streets sufficiently wide for grand carts and carriages. Perhaps they’d been happy to walk.

Men like the man who pulled me that day could have walked four by four; unlike his mule, he was thin as the gates. I watched him amble—lovely, light steps—and the only sound in the town was mule hoof on street.

Now he didn’t know me and I didn’t know him but my backpack probably explained a lot, and my eagerness, too. And I’m certain my Spanish—blunt and not sweet—had helped earn me free passage that day. But I was content to be thought a traveler. Afterall, I was just that, and maybe, I thought, maybe he knew who lived behind these white walls, where I could sit and bite olives.

Olives are Arcos and oranges are, too. Their scents haunt the air; I couldn’t stop smelling. But I stopped when he stopped. The man pulling me stopped in the middle of town and reached into a bag on his old leather belt. He pulled out a thing which I would not think men tote—a puppet, tiny and brown, but a little bit red. Red where someone had painted his shirt.

And then, as bulls do, the children came out. They came out of white doors to see that red puppet. The square held them there; a square lined with benches and guarded by trees, but not olive trees. These were orange trees. But not the oranges you eat. These oranges were stored in barrels on ships and then made into marmalade, and they were also good for tossing. My senora had explained that. And I guessed that these children tossed them often and happily, and probably off of the hilltop.

The oranges were pale though, compared to the puppet. The children knew what he could do, and they watched the thin man and I watched him, too, as he made his puppet walk. He hadn’t bothered to tie up his mule, and I sat on its back—fat and heaving—and wondered if the man was a farmer or just a minstrel that made children laugh.

I laughed, but not too much, because my eyes looked away. I looked at the children and their bronzed skin. Their simple eyes wide and bright, very bright. I thought they must play hard and sleep well at night. Most of them were thin, like the man, though their laughter was fat. It echoed off white walls ‘til one mother called: que te vengas!

It was six o’clock.

I think I got lucky that day; I dismounted my mule and received an invite to eat olives inside white doors. I don’t think I’ve ever known olives so good—an old taste that lingers. Old like Arcos and fat like the mule. And full like the children, who laughed at the table and questioned my speech. I told them everything about my home. They wanted to know this, for they’d never seen it. I will never forget seeing theirs.








.MGW.

FDA PanelWords

--Drug-Eluting Stents Not Safe for All...Yet--

[This piece is a continuation of an investigation I'm doing for Anesthesiology News in light of the FDA panel that convened earlier this month.]

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, according to a study published last month in the Journal of Clinical Anesthesia.

Presumably, the heart attack was a result of discontinuing Plavix®—the anti-clotting medication required after placement of a drug-eluting stent.

Providing adequate surgical care for patients with drug-eluting stents is a big issue,” said the study’s lead author, Mayo Clinic anesthesiologist Michael Brown.

This issue surfaces amidst general controversy over drug-eluting stents. Earlier this month, the FDA convened a two-day panel in Gaithersburg, Maryland, to evaluate the safety of these devices, which now prop open the arteries of 3 million Americans.

Unlike conventional stents, drug-eluting stents ooze chemicals designed to battle restenosis, or renarrowing. But the chemicals they spew not only prevent the growth of artery-clogging cells, they also inhibit cells that would naturally fight clotting.

This means that patients with drug-eluting stents suffer suppressed anti-clotting systems and should stay on medications like Plavix for several months to a year.

According to Roger Moore, vice president of the American Association of Anesthesiologists, people on anti-clotting medication present unique challenges for anesthesiologists. That’s because anti-clotting drugs reduce the tendency to clot at the expense of bleeding—a risk inherently high during surgery. As such, patients on medications like Plavix are often recommended to discontinue their regimens before surgery.

But without Plavix, clotting risks skyrocket, and clotting—unlike restenosis—is linked to heart attacks, and even death.

The FDA panel in Gaithersburg sought to determine how likely drug-eluting stents are to cause long-term blood clots, and what should be done. While the American Heart Association recommends at least 3 to 6 months of Plavix treatment following drug-eluting stent placement, the optimal duration of this medication has not yet been established. The Gaithersburg panel meeting marked the first time the FDA sought the help of anesthesiologists and surgeons to inform such guidelines.

During the trial, presentations by doctors and stent manufacturers and data from numerous studies verified that drug-eluting stents increase clotting—both for approved patients, as well as for those who are “off-label.” Despite clotting risks, however, the panel concluded that drug-eluting stents are safe, as long as they’re used in conjunction with anti-clotting medication and in the intended population.

But—as evidenced by Michael Brown’s study—drug-coated stents cause problems even within the FDA-approved group when people who have them undergo surgery.

“The fact of the matter is that more and more people will be getting drug-eluting stents,” said Richard Shemin, a cardiac surgeon who was present on the FDA panel, “and surgeons and anesthesiologists are going to have to learn how to take care of people who have them.”

The most obvious strategy, according to Dr. Moore, is to postpone surgical procedures during the 6 month window directly after stenting.”

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. His medical center has formed a Plavix Taskforce Committee to encourage interdisciplinary discussion.

“The problem now is that too often these conversations don’t take place,”
said Thomas Slater, an interventional cardiologist at NYU’s Tisch Hospital in Manhattan. He emphasized the need for anesthesiologists to consult with a patient’s cardiologist to understand the trade-off between the risk of stent thrombosis, or clotting, versus the risk of surgical bleeding.

“Anesthesiologists should learn why and when the stent was placed, how big it was, and how long the patient has been on anti-clotting medication,” said Dr. Slater. The risk of stent thrombosis is contingent upon these factors, as well as others such as presentation of the initial acute coronary syndrome, vessel lesions, bifurcation stenting, and an underdeployed stent.

In patients for whom the clotting risk is low, discontinuing Plavix to avoid excessive bleeding is less of a concern. For patients at an increased risk, however, remaining on anti-clotting medication during surgery should be a definite consideration.

And there are other ways anesthesiologists and surgeons can make the operating room safer for patients with drug-eluting stents.

For example, while stenting may have successfully opened significant obstructions in a patient’s major coronary arteries, obstructions could still exist in coronary arteries in the periphery. “This needs to be considered in approaches to anesthetic management,” said Dr. Moore.

He said that anesthesiologists operating on patients with drug-eluting stents should also avoid anesthetic 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.

Finally, a study published this month in the Canadian Journal of Anesthesia discusses the potential for new anti-clotting medications—drugs with predictably short onsets and offsets of anti-clotting action. A patient on such a drug could stop the long-acting antiplatelet agent and switch to the short-acting, reversible one before surgery, to minimize bleeding. The short-acting agent could even be continued throughout the surgical procedure if the bleeding incurred was not excessive.

“Ultimately, drug-eluting stents are still great 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.

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.

Drug-Eluting StentWords

--Drug-Eluting Stent Controversy: No Clear-Cut Answer--

Drug-eluting stents, called by some the biggest breakthrough for interventional cardiology in 25 years, have been the source of recent controversy. These devices appear to pose a higher risk of blood clots, which can lead to heart attacks, than conventional bare-metal stents. An FDA panel convened last week in Gaithersburg, Maryland, to evaluate this risk.

Drug-eluting stents ooze medicine that prevents arteries from growing scar tissue and ultimately, from renarrowing--a problem commonly associated with conventional stents. When drug-eluting stents hit the market in 2003, they were highly endorsed by cardiologists and have been widely used ever since, inhabiting the arteries of 3 million Americans.

Now, it seems these drug-spewing stents are more likely to cause blood clots--a risk considered more severe than the renarrowing associated with stents of old. This risk can be minimized, however, when patients remain on anti-clotting medications, like Plavix and aspirin. But this medication is very expensive and induces bleeding during prolonged use.

And there is yet another problem associated with drug-eluting stents; patients who have them and later undergo surgery must be taken off of their anti-clotting medication so as to minimize chances of perioperative bleeding. But discontinuing anti-clotting medication invites risk of late stent thrombosis (clotting).

Thus, the trade-off: patients with drug-eluting stents who undergo surgery can either stay on their anti-clotting meds and endure complications associated with bleeding, or discontiue them entirely, risking clot formation that could lead to heart attacks.

I'm speaking with cardiologists across the nation, and anasthesiologists, too, to see how they will resolve the issue of drug-eluting stent safety. More to come. And it will start with George Vetrovec in Virginia.

.MGW.