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New Absorbable Cardiac Stent

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Ronin786

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The first significant advance in heart stents in more than a decade is providing U.S. patients and their doctors with a new option for treating blockages in the coronary arteries that cause chest pain and heart attacks.

Last week, cardiologists began implanting Abbott Laboratories ’ new biodegradable stent called Absorb in patients following its approval last Tuesday by the U.S. Food and Drug Administration. Unlike the permanent metal devices that have been used to prop open diseased vessels for more than 20 years, Absorb is designed to fully dissolve within two to three years after it is deployed.

Proponents of the new device believe it holds the potential for long-term benefits over metal stents, including widely used drug-coated stents that have dominated the market since 2003. Some 850,000 patients in the U.S. are treated with stents each year.

“As good as the drug-coated stents have been, there is a downside,” says David Rizik, an interventional cardiologist at HonorHealth Scottsdale Shea Medical Center in Arizona.

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ENLARGE
This is a pre- and post-procedure look at Mr. Taylor's stented artery. The inset on the right is an image of the vessel taken from the inside. The little square boxes around the circumference of the artery show that the stent is properly place against the artery wall.Photo: David Rizik, MD/HonorHealth
After the first year, new disease can accumulate in metal devices, with the result that 2% to 3% of patients a year suffer a heart attack or other serious problem related to the treated obstruction. Doctors often put patients on a prolonged blood-thinning regimen to reduce risk of a life-threatening clot. Metal stents can complicate diagnosis and future treatment, including bypass surgery, when symptoms recur as they often do.

The hope is that a dissolving stent will reduce the need for repeat procedures in later years, enable many patients to shorten the time they’re on blood thinners and help restore normal motion to their arteries.

“The promise of the device is three to five years down the road,” Dr. Rizik says. Dr. Rizik is a member of Abbott’s medical advisory board.

The argument made sense for Doug Taylor, a 73-year-old avid runner and owner of a wealth-management firm in Scottsdale, Ariz. He became the first patient in the U.S. to get the new absorbable stent after it won FDA approval when Dr. Rizik performed the procedure on Wednesday.

“I really like the idea that it’s going to dissolve and be out of there,” Mr. Taylor says.

That said, the anticipated long-term benefits of the dissolving device are yet-to-be proven. Results of studies examining the question are due within the next several years. Meantime, some cardiologists are concerned about the absorbable stent’s near-term performance.

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ENLARGE
The new biodegradable heart stent from Abbott Laboratories Photo: F. Martin Ramin/The Wall Street Journal

The 2,008-patient clinical trial that led to its approval found that after one year the absorbable device was essentially equivalent in efficacy and safety to Abbott’s drug coated metal stent called Xience, which remains in the body permanently. Actual differences, though not statistically significant, went against the new device: 7.8% of Absorb patients and 6.1% of Xience patients suffered a serious adverse event related to the treated blockage.

In particular, the rate of stent thrombosis—the potentially catastrophic formation of clots in the device—was 1.5% for Absorb compared with 0.7% for Xience. That indicates stent thrombosis affects 15 of every 1,000 Absorb patients versus about 7 people per 1,000 with Xience. Studies in Europe, where the device has been on the market for several years, have revealed a similar trend.

“The concept of self-degrading stents is intuitively attractive,” Robert Byrne, a cardiologist in Munich, Germany, wrote in an editorial last fall in the New England Journal of Medicine. But “promise alone is not enough to make us unconditionally embrace this technology.” Unless their advantages become evident, they won’t be widely accepted, he said.


The main problem, researchers believe, is that absorbable stents are bulkier and less forgiving than the metal ones. That means people with very small arteries, who may be more vulnerable to a clot, and those with very large ones aren’t good candidates for the device. Nor are patients with substantial calcification of the deposits in their arteries or with twisting vessels, doctors say.

That means cardiologists need to take extra care to estimate the size of patients’ vessels before recommending the dissolvable stent and to make sure they implant it completely against the vessel wall. That will likely require sophisticated imaging and other equipment that could increase the cost of the procedure.

“This technology will not achieve its projected benefit if (cardiologists) don’t apply it precisely,” says Marco Costa, an interventional cardiologist at University Hospitals Case Medical Center, Cleveland, and a proponent of the device.

Cost implications haven’t been fully analyzed, doctors say, but any additional upfront costs could be offset by future savings if the costs of repeat procedures and other metal-stent related treatments are reduced. Doctors expect future versions of absorbable stents will solve some of the current limitations.

Mr. Taylor says he carefully weighed the pros and cons before accepting Dr. Rizik’s recommendation that he be treated with the new stent. Since his father died in 1973 at age 63 after having suffered several heart attacks, Mr. Taylor has embarked on a deliberate effort to avoid a similar fate.

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ENLARGE
Heart patient Doug Taylor, in green, and his doctor, David Rizik, an interventional cardiologist at HonorHealth Scottsdale Shea Medical Center in Arizona. Photo: HonorHealth
He began running along the Delaware River that year, when he lived in New Jersey. Then he accepted a friend’s invitation to run a 10K race in New York’s Central Park and got hooked. He soon progressed to marathons and then to 50-mile and 100-mile road races.

Recently, he began experiencing chest pain and nausea whenever he ran faster than a 14-minute mile. An initial evaluation didn’t turn up any heart trouble, but the problem persisted.

A few weeks ago, the pain and nausea came even when he wasn’t running. A trip to the emergency room in early June led him to the cardiac catheterization lab where Dr. Rizik discovered a 90% blockage in one artery and an 80% obstruction in another.

He opened the most occluded vessel with a metal stent, and Mr. Taylor’s pain went away. Then Dr. Rizik told him approval of the new stent was imminent and he could be the first patient in the U.S. to get one for the other blockage. That was in his left anterior descending artery, the heart’s most important vessel.

“I’m like, ‘um, it sounds like guinea pig to me,’ ” Mr. Taylor says. But he agreed to consider it and in the end, his running experience was a factor in his decision.

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Cardiologists at HonorHealth Scottsdale Shea Medical Center as they implant the absorbable stent in Doug Taylor on Wednesday, July 6. They are looking at an Optical Coherence Tomography imaging screen. Photo: HonorHealth

In marathons and 100-mile races, “you know right from the very beginning that the finish line is a long way away,” he says. “I didn’t want to do something that just gets me over the symptoms of today.”

During last Wednesday’s procedure, Dr. Rizik encountered moderate calcification in the blockage, requiring “meticulous” stretching of the artery with a balloon, he says. The device was successfully placed and imaging with infrared light technology revealed “a wide open vessel,” he says.

Later, Mr. Taylor experienced chest pain that Dr. Rizik told him may have resulted from the stretching. Dr. Rizik performed a second catheterization to check the stent and found everything ok. Overall, “we had a terrific result,” he says.

Back home over the weekend, Mr. Taylor says “things seem to be heading back to normal.” He’s looking forward to Aug. 1, when Dr. Rizik said he could resume running. At some point he’d like to do another marathon.

“I’ve run New York four times,” he says, and “wouldn’t mind” doing it again.
 

Ronin786

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As the article mentions, the new stents have twice the in-stent thrombosis rate of your average DES. Is it going to take two years before elective surgery now?
 
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PainDrain

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I seriously wonder why this is being allowed into the market. It is clearly a less effective therapy with twice the rate of stent thrombosis.
 

GravelRider

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I suppose the argument is that you accept a higher rate of in stent thrombosis to potentially have a lower rate of in stent stenosis down the line? This is very similar to what the trade offs are when comparing DES vs BMS. Did the patients with the absorbable stent take anti-platelet agents until the stent was absorbed? I wonder if a drug-eluting absorbable is the next step? I think it seems promising...especially for young patients with CAD.
 
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deleted171991

So is everyone still using 12 months for DES and 1 month for BMS?
Generally yes. That's the class I evidence recommendation. There is also evidence for harm with periop discontinuation of DAPT, earlier. I need a really good benefits/risks ratio to change my mind.
 
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Orin

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Sounds like a nice way for a cardiologist to do more stents...
 

Mman

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Sounds like a nice way for a cardiologist to do more stents...

that's exactly what I thought.

What's the difference between an absorbable stent and regular old angioplasty? The duration you hold it open for? I mean you open it up and then it eventually restenoses.
 

BLADEMDA

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The following discussion applies to patients scheduled to undergo noncardiac surgery who have undergone percutaneous coronary intervention (PCI) with stenting within one year. In such patients, it may be necessary to stop one or both antiplatelet agents prior to our recommended duration of such therapy (one year) or even prior to the minimum required duration of treatment with dual antiplatelet therapy (DAPT) for the general population, which is a minimum of one month after bare metal stents (BMS) and for at least six months after drug-eluting (DES). We acknowledge that with second generation DES, it is likely that the difference between in the minimum duration for BMS and DES is less.

http://www.uptodate.com/contents/noncardiac-surgery-after-percutaneous-coronary-intervention
 
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BLADEMDA

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Is Surgery Safe for Stent Patients?


Despite conflicting findings, experts suggest that current guidelines are still accurate. Patients with bare metal stents can undergo surgery six weeks after their stent procedure with very low risk of complications. And blood thinners should still be used when possible to reduce risk of complications during surgery. However, it’s possible that patients with drug-eluting stents don’t need to wait a year to undergo surgery, as current guidelines suggest. Waiting six months after receiving a drug-eluting stent may be just enough time to undergo an operation with very low risk of complications.

https://www.cardiosmart.org/News-and-Events/2013/10/Is-Surgery-Safe-for-Stent-Patients
 

BLADEMDA

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So is everyone still using 12 months for DES and 1 month for BMS?

The Guidelines do recommend waiting 1 year after a DES prior to scheduling elective surgery. For BMS 6 weeks-90 days (or even 6 months) has been the typical answer. The ASA/ABA as of 2016 is still using 30 days and 1 year respectively.

The correct "clinical decision" in 2016 is if the patient receives Cardiology's blessing to proceed with elective surgery just 6 months after a DES (especially a second generation stent) then the studies show it is fine to proceed with the case. A review of the evidence shows little difference in MACE at 6 months vs 1 year. I would strongly recommend not discontinuing the Aspirin prior to surgery if at all possible.

FYI, I have had a patient with a DES clot off a coronary stent immediately after surgery. The patient had massive ST elevations with hypotension requiring emergent balloon angioplasty in the Cath lab just 45 minutes after surgery. Fortunately, everything ended up okay and the patient survived the event. By the way, I had placed an arterial line immediately post induction for this patient which I believe made a valuable contribution in dealing with the hypotension postop and in the cath lab.

These days I place a lot of arterial lines and I rarely, if ever, regret doing a 5 minutes procedure (10 minutes if difficult and U/S is needed) for ASA 3 and 4 patients undergoing any type of moderate to high risk surgery.

Glidescopes and U/S for line/block placements have truly impacted my practice in a positive way.
 
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GravelRider

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The Guidelines do recommend waiting 1 year after a DES prior to scheduling elective surgery. For BMS 6 weeks-90 days (or even 6 months) has been the typical answer. The ASA/ABA as of 2016 is still using 30 days and 1 year respectively.

The correct "clinical decision" in 2016 is if the patient receives Cardiology's blessing to proceed with elective surgery just 6 months after a DES (especially a second generation stent) then the studies show it is fine to proceed with the case. A review of the evidence shows little difference in re-stenosis at 6 months vs 1 year. I would strongly recommend not discontinuing the Aspirin prior to surgery if at all possible.

FYI, I have had a patient with a DES clot off a coronary stent immediately after surgery. The patient had massive ST elevations with hypotension requiring emergent balloon angioplasty in the Cath lab just 45 minutes after surgery. Fortunately, everything ended up okay and the patient survived the event. By the way, I had placed an arterial line immediately post induction for this patient which I believe made a valuable contribution in dealing with the hypotension postop and in the cath lab.

These days I place a lot of arterial lines and I rarely, if ever, regret doing a 5 minutes procedure (10 minutes if difficult and U/S is needed) for ASA 3 and 4 patients undergoing any type of moderate to high risk surgery.

Glidescopes and U/S for line/block placements have truly impacted my practice in a positive way.

Re-stenosis is not the problem with a DES. It is in stent thrombosis that is the problem. They are two different pathologies. A drug eluting stent prevents epithelialization of the vessel lining, which reduces the risk of re-stenosis compared to a BMS. However, this lack of epithelialization provides a perfect nidus for clot formation, thus the reason you saw a STEMI post-op. STEMIs are usually from acute formation of clot and not a stenotic vessel. This is why a patient with DES needs to be on anti-platelet agents.

I use the 1 year, 1 month rule. Exceptions exist, but only with Cardiology's blessing and an attempt at convincing the surgeon to push through with anti-platelet agents on board.
 
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BLADEMDA

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Re-stenosis is not the problem with a DES. It is in stent thrombosis that is the problem. They are two different pathologies. A drug eluting stent prevents epithelialization of the vessel lining, which reduces the risk of re-stenosis compared to a BMS. However, this lack of epithelialization provides a perfect nidus for clot formation, thus the reason you saw a STEMI post-op. STEMIs are usually from acute formation of clot and not a stenotic vessel. This is why a patient with DES needs to be on anti-platelet agents.

I use the 1 year, 1 month rule. Exceptions exist, but only with Cardiology's blessing and an attempt at convincing the surgeon to push through with anti-platelet agents on board.


My apologies to the "stent thrombosis" issue. The correct term is MACE. That said, the evidence for proceeding at 6 months with just aspirin on board looks pretty good and I'm fine with it because the Cardiologist who did the stent has signed off on the patient "safe to proceed with surgery." After all, I'm not going to stop the DAPT (dual anti platelet therapy) even at 12 months without consulting the Cardiologist (or the same group) who placed the stent in the first place.

So far, I've done 4 elective cases in patients just 6 months after DES placement without any issues. The one patient who had "stent thrombosis" postop was more than 12 months out from his original DES stent placement and had been off both his anti-platelet meds for 7 days. If that patient had his surgery performed at an ASC instead of my facility the odds are highly likely the end result would have been death.
 
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Mista Suprane

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New 2016 ACC/AHA guidelines for non-cardiac surgery after PCI, based on new evidence, on page 35 of this article: http://circ.ahajournals.org/content/circulationaha/early/2016/03/28/CIR.0000000000000404.full.pdf. (@BLADEMDA is right, so I will change my practice.)

Here's the essence of it:

View attachment 206293

this is slightly different than what I have been using based on the following article in 3/2016. specifically, this article is a focused update on DAPT by the ACC/AHA.

basically, it matters WHY they got the stent placed. do they have stable ischemic heart disease (SIHD)? or was the stent placed during an ACS?

6 months if stent was placed for SIHD (this is the guy who had a positive stress with minimal symptoms who then had a cath that showed a lesion that could be stented)
12 months if stent was placed for ACS

https://professional.heart.org/idc/...op/@smd/documents/downloadable/ucm_484255.pdf

dapt.JPG
 
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deleted171991

It's the same article, published in multiple journals. Your algorithm is on page 15 of my link, and my algorithm is on slide 41 of yours. ;)

Interestingly, the part about elective surgery does not make any difference between ACS and non-ACS. Probably because we are talking about short-term discontinuation, so it's a few percentiles divided by 52.
 
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Mista Suprane

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It's the same article, published in multiple journals. ;)
Truth.

Interesting however, that their recommendations for optimal DAPT (the flowsheet that I posted) are not congruent with their recommendations for surgery (the flowsheet that you posted).

"If you had a DES placed for ACS, you should continue DAPT for 12 months. Unless you are having elective non cardiac surgery, in which case it is OK to stop at 6 months."

That doesn't make sense to me.
 
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deleted171991

Truth.

Interesting however, that their recommendations for optimal DAPT (the flowsheet that I posted) are not congruent with their recommendations for surgery (the flowsheet that you posted).

"If you had a DES placed for ACS, you should continue DAPT for 12 months. Unless you are having elective non cardiac surgery, in which case it is OK to stop at 6 months."

That doesn't make sense to me.
It makes sense to me. This is like short-term discontinuation of anticoagulation for AFib. We do it all the time, because the risk, for that one week or so, is much less than 1%.

Same for DAPT. The risk of thrombosis, for a short period, after the stent had time to epithelialize, is probably negligible. Still:

"Decisions about the timing of surgery and whether to discontinue DAPT after coronary stent implantation are best individualized. Such decisions involve weighing the particular surgical procedure and the risks of delaying the procedure, the risks of ischemia and stent thrombosis, and the risk and consequences of bleeding. Given the complexity of these considerations, decisions are best determined by a consensus of the surgeon, anesthesiologist, cardiologist, and patient."

Also:

"In patients with ACS treated with DAPT after DES implantation who develop a high risk of bleeding (e.g., treatment with oral anticoagulant therapy), are at high risk of severe bleeding complication (e.g., major intracranial surgery), or develop significant overt bleeding, discontinuation of P2Y12 inhibitor therapy after 6 months may be reasonable (17-21,34,36,37)."

It's all about risks vs benefits. And I'm still going to ask for a cardiac consult regarding DAPT.
 
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Mista Suprane

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The risk of thrombosis, for a short period, after the stent had time to epithelialize, is probably negligible.

Technically correct, however the perioperative period is a tremendously thrombogenic period. any surgical procedure causes a hypercoagulable state.

And unlike atrial fibrillation, where the incidence of stroke is measured in strokes/year without treatment, in-stent thrombosis is a high morbidity/mortality event.

I completely understand liberalizing the guidelines to reflect the introduction of newer generation stents - frankly, the medical community has been waiting for this for almost two years, ever since the European data was released trending towards that liberalization. However, to continue to recommend 12 months for ACS, regardless of generation of stent for optimal medical therapy, and then turn around and say it is OK to come off DAPT at 6 months for a completely elective noncardiac surgery (lets say, an elective septorhinoplasty to put us on the same page), is, like I said, incongruent.

If the ACC/AHA believed that the stents were truly better and had less risk of in-stent thrombosis at 6 months, the recommendation would be to stop DAPT at 6 months, regardless of why it was placed (SIHD or ACS). They have not made that recommendation. So why should we proceed with an elective septorhinoplasty at 6 months instead of 12 months?
 
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deleted171991

So why should we proceed with an elective septorhinoplasty at 6 months instead of 12 months?
I will let the cardiologist answer that question, like Blade does. But I will definitely be more careful with post-ACS stents.

I agree, it sounds like the guidelines are sending a mixed message.
 
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GravelRider

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It makes sense to me. This is like short-term discontinuation of anticoagulation for AFib. We do it all the time, because the risk, for that one week or so, is much less than 1%.

Same for DAPT. The risk of thrombosis, for a short period, after the stent had time to epithelialize, is probably negligible. Still:

"Decisions about the timing of surgery and whether to discontinue DAPT after coronary stent implantation are best individualized. Such decisions involve weighing the particular surgical procedure and the risks of delaying the procedure, the risks of ischemia and stent thrombosis, and the risk and consequences of bleeding. Given the complexity of these considerations, decisions are best determined by a consensus of the surgeon, anesthesiologist, cardiologist, and patient."

Also:

"In patients with ACS treated with DAPT after DES implantation who develop a high risk of bleeding (e.g., treatment with oral anticoagulant therapy), are at high risk of severe bleeding complication (e.g., major intracranial surgery), or develop significant overt bleeding, discontinuation of P2Y12 inhibitor therapy after 6 months may be reasonable (17-21,34,36,37)."

It's all about risks vs benefits. And I'm still going to ask for a cardiac consult regarding DAPT.

I don't think we know the true rate of in-stent thrombosis for a DES in the first year. I suspect it is higher than 1%. There are probably co-morbidities that predict higher risks for in-stent thrombosis, much like there are predictors for stroke in Afib. Not every Afib patient needs to be anticoagulated.

I don't think we have great guidelines for this decision. It's more of a "if the cardiologist says it's ok." Surgery is already a thrombogenic state. Couple that with a DES and you have the potential for a problem. If a guy had a DES in his left main and it's under a year, I don't care if the cardiologist and the Pope gave his blessing, that guy is staying on his DAPT.
 
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Mista Suprane

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If a guy had a DES in his left main and it's under a year, I don't care if the cardiologist and the Pope gave his blessing, that guy is staying on his DAPT.

You bring up a great point - my colleagues and I discuss this specific point often. There is room for interpretation, and the location of the stent will absolutely have an impact regarding which way I choose to go with a case. I would feel similarly for a LM or LAD stent. If it was a tiny branching vessel, maybe not.

I try to never miss an opportunity to be a doctor, vs. just follow a guideline.
 

BLADEMDA

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I don't think we know the true rate of in-stent thrombosis for a DES in the first year. I suspect it is higher than 1%. There are probably co-morbidities that predict higher risks for in-stent thrombosis, much like there are predictors for stroke in Afib. Not every Afib patient needs to be anticoagulated.

I don't think we have great guidelines for this decision. It's more of a "if the cardiologist says it's ok." Surgery is already a thrombogenic state. Couple that with a DES and you have the potential for a problem. If a guy had a DES in his left main and it's under a year, I don't care if the cardiologist and the Pope gave his blessing, that guy is staying on his DAPT.

Or the patient has 3 coronary stents placed 6 months ago. Ultimately, I think Cardiologists fail to grasp just how pro-thrombotic the intraop/postop period really is to the patient. I do agree with the thinking that waiting longer is better but the literature is quite clear the risk is minimally increased after 6 months vs one year (non ACS stent placement). Since I practice evidence based medicine as much as possible, I will agree to proceed with elective surgery on these patients provided they have a Cardiology note preop and the patient understands that his/her stent could clot off (small but real risk).
 

Mista Suprane

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Ultimately, I think Cardiologists fail to grasp just how pro-thrombotic the intraop/postop period really is to the patient

My experience is overwhelmingly this. Also, many of them do not even know their own current guidelines.
 

GravelRider

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My experience is overwhelmingly this. Also, many of them do not even know their own current guidelines.

Unfortunately, that is my experience with cardiologists as well. My take on this is that there are too many shades of gray. If it truly is an elective case, do the benefits of doing it now vs waiting really outweigh the risks?
 

Mista Suprane

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Unfortunately, that is my experience with cardiologists as well. My take on this is that there are too many shades of gray. If it truly is an elective case, do the benefits of doing it now vs waiting really outweigh the risks?
I 100% agree with you.

Thankfully, the 6 month vs 12 month discussion is rarely the issue in my current practice. Most patients with stents presenting for surgery are a couple years out.

The big issue we have had is the inappropriate cessation of ASA in patients with stents.

Cardiology "Would recommend continuing ASA perioperatively, however will ultimately leave that decision to our surgical colleagues."
Surgery "Cardiology said we can stop ASA, please tell the patient to stop his ASA 7 days before surgery."
Anesthesiology (day of surgery) "Sorry, we can't do this case."
 

BLADEMDA

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Unfortunately, that is my experience with cardiologists as well. My take on this is that there are too many shades of gray. If it truly is an elective case, do the benefits of doing it now vs waiting really outweigh the risks?

And as I have posted stent thrombosis isn't theoretical any longer to me. I've seen it and dealt with it. The patient was fortunate to survive the event because at the time the Cardiologist (on call) and I thought the chances weren't good for survival.
 
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