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Posts Tagged ‘CVA’

Now all of my long-term readers should be able to spot the flaws in the logic here. One study, funded by a drug company with results that are at odds with just about every other study ever published – and that’s the one the FDA uses to approve/ expand the indications for stenting? Guess it’s just another ‘easy’ solution to sell to patients / primary care providers who don’t have the time and resources to review the literature themselves.  No surprise, since I am guessing that cardiologists will be placing the majority of these stents..

From HeartWire:
FDA approves expanded indication for carotid stenting
May 6, 2011 | Susan Jeffrey

Adapted from Medscape Medical News—a professional news service of WebMD
Silver Spring, MD – The US Food and Drug Administration announced today it approved an expanded indication for the RX Acculink carotid stent system (Abbott Vascular, Santa Clara, CA) to include patients at standard surgical risk for carotid endarterectomy [1].

Previously, the RX Acculink stent, used in conjunction with Abbott’s Accunet or Emboshield embolic-protection devices, was approved for use only in patients requiring carotid revascularization who were at high surgical risk. These high-risk patients were also required to have a reference vessel diameter ranging from 4.0 mm to 9.0 mm at the target lesion and be symptomatic with a stenosis of the common or internal carotid artery of >50%.

The stent was also previously approved in high-risk patients without neurological symptoms but with a stenosis of the common or internal carotid artery >80%.

In January, the FDA’s Circulatory System Devices Panel voted 7 to 3 in favor of this expanded indication for the system, saying the benefits of carotid stenting in patients at standard risk for adverse events from endarterectomy outweighed the risks. wait – are you sure about that?? because most of the data shows that surgical risk is actually well under 1% – and that’s looking at VA studies involving tens of thousands of patients, with multi-year follow-up..

The panel also voted 6 to 4, with one abstention, in support of the safety of carotid stenting in standard-risk surgical patients and 8 to 2, again with one abstention, in a vote that asked about the effectiveness of therapy in this expanded patient population.

“Expanded access to RX Acculink means patients and their healthcare providers have another option for treating clogged neck arteries,” Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a statement.

The FDA based its approval on the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), a 10-year study of 2502 symptomatic and asymptomatic patients at 119 clinical sites in the US and Canada, funded by the National Institute of Neurological Disorders and Stroke with supplemental funding by Abbott.

Patients were treated and followed for at least one year. Results of that study, published in the New England Journal of Medicine, showed that patients treated with stenting had a similar combined rate of death, stroke, and MIs those who underwent surgery [2].

Those who underwent surgery, however, had fewer strokes, and those who had stenting had fewer MIs over follow-up. There was also an effect of age, where older patients had fewer events with surgery, while younger patients had slightly fewer events with stenting. Wait a minute – older patients – surgery is actually safer.. but remember, that’s the excuse we received from the beginning – ‘stents are for the frail old people’.. define ‘slightly fewer’ – does that mean ‘not statistically significant’ because that’s what it sounds like. [cartagena surgery]

The FDA advisory panel emphasized the need for additional long-term follow-up information and the importance of the stent’s use in conjunction with an embolic-protection device.

As a condition of the approval, Abbott is required to conduct a postapproval study that will follow new patients treated with the stent system for at least three years to confirm the results identified in CREST.

The postapproval study will also evaluate how patients age 80 years and older respond to treatment, whether treatment success is affected by operator experience, and whether symptomatic and asymptomatic patients have different outcomes.

“The study is consistent with recommendations made by the expert advisory panel,” the FDA statement notes

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As some of you know – I took on the coffee challenge in graduate school after a few stupid comments from classmates over my coffee drinking habit (I like about four cups a day).. So as part of a grad school assignment I reviewed the literature surrounding coffee, and the active ingredients in coffee and it’s kin (cocoa) and wrote about the health benefits of the methylxanthines; theophylline, theobromide, and caffeine.. I talked about the use of theophylline to prevent anoxic injury to the brain and to help restore spontaneous circulation in people after brady/asystolic arrest..
I also debunked some of the common myths surrounding ‘theophylline toxicity’ and it’s unwarrented and tarnished reputation.**

** (check the potassium level, everyone – and know that the effective / therapuetic range is actually 5 to 10 not 10 to 20)

Since then I hae been ardent follower of coffee drinking/ health stories..
– We now know it doesn’t precipitate atrial fibrillation – as demonstrated in several very large studies last year..

– It’s protective against diabetes and pancreatic cancer..

and now, ladies – it appears the health effects extend to a stroke benefit as well.. Now, maybe it isn’t all true – but the next time someone makes a smarmy comment about coffee harming your health – here’s some ammo to fire right back at them..

Here’s some links to the story- which was widely reported, and picked up by AP.

Coffee reduces Stroke

http://news.yahoo.com/s/ap/20110310/ap_on_he_me/us_med_coffee_stroke

http://consumer.healthday.com/Article.asp?AID=650753

LA timesNow – just make sure you haven’t ruined it with 300 calories worth of fat and sugar..

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If you’ve been following the cardiology and vascular surgery journals – then you’ve been bombarded with articles about strokes in the last two days.

The first series has blazing headlines linking the increased rate of strokes in young people with diet soda consumption (excess salt consumption, obesity, poor dietary habits).

The second series of articles discuss the very topics we’ve been discussing here at Cartagena Surgery.. Surgery versus Stenting..  But as people have been asking, are the two related??

Probably not.  The proposed causes of the increased incidence of stroke in people aged 15 – 44 is theorized to be related to increased sodium intake – which in turn causes hypertension.  Hypertension itself may increase the ‘chipping’ effect on plaques in the carotid artery (in people with pre-existing carotid disease)

or may cause strokes themselves by causing blood vessels in the brain to rupture from the increased pressure.  In young people, it is usually the latter.. (because it usually takes a long time to accumulate carotid plaques.) Unfortunately, it’s this younger population that often goes undetected/ untreated or fails to realize the significance of the diagnosis.  Hypertension/ high blood pressure is a serious condition, and aggressive treatment is warrented.. It’s never just high blood pressure.. It’s THE number one cause of kidney failure, the number one cause of heart failure, and a major cause of stroke (just to name a few.)  and it’s usually easily treatable.

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As Featured On EzineArticles

Carotid stenting sounds like a wonderful solution to the layperson.  But the truth is always more complicated.  I’ll talk about it more here to give a better understanding of the disease, diagnosis, and treatment options.

The carotid arteries

The carotid arteries (along with the vertebral arteries) bring blood to the brain. Plaque embolization (or flecks of plaque breaking off diseased or blocked arteries) is one of the main causes of embolic (or non-bleeding) strokes.  In people with blockages in this artery, treating or removing the plaque can prevent stroke.

Today we will talk about screening and diagnosis.. Next time: treatment options.

Detecting Carotid Stenosis:

These blockages can be detected with the use of a carotid doppler (or ultrasound) to listen to the speed of the blood (velocities) in the carotid artery and to visualize blockages.  Some blockages can also be heard on physical exam –  as a bruit (bru-ee) but this is not always a reliable indicator, as the most severe stenoses (or narrowing from plaque) usually don’t have a bruit.

Results are reported as a range – and this decides treatment options.  Generally, in people that have NOT had a stroke – surgical treatment is not advised until the blockage is 70 – 80% blocked.  This is because the risk of stroke increases with the amount of blockage, as the speed of the blood increases to pass through the narrowed space.  (Picture a garden hose, now put your thumb over the end, covering most of it and make the water shoot out – that’s what we mean by increased velocity.)

If you have had a stroke or mini stroke from a plaque breaking off and travelling to the small vessels of the brain, the doctors will usually operate with lesser blockages – because you have already demonstrated a tendency to have pieces break off.

Now this is important – strokes usually happen because of high grade (70 or higher stenosis) not occlusions (or 100% blockages).  That’s because there is more than one vessel bringing blood to the brain – (remember the vertebrals we mentioned earlier..)  Doctors do not undo occlusions because that actually increases the risk of stroke at the time of surgery.

If you have an occlusion – count yourself as lucky that you didn’t have a stroke when it was 99%  and worry about keeping the remaining vessels as clean as possible with medicines.

Screening for Carotid Stenosis:

Currently there are no screening guidelines for asymptomatic individuals.  Since symptomatic means the person has had a stroke or TIA (mini-stroke) knowing when to screen is important.

Generally screening should be done in people at high risk for developing accelerated plaque formation – and in people with vasculopathic disease history (people with a history of plaque or blockages other places.)

High risk for accelerated plaques:

1. Diabetes – diabetes accelerates plaque formation, which is why new guidelines suggest ALL people with Diabetes, regardless of blood cholesterol tests should be on a statin drug (simvastatin, rosuvastatin, lovastatin, atorvastatin, pravastatin)*

2. History of smoking – smoking causes similar effects inside blood vessels as diabetes.  As I explain to patients in the office, it makes plaque form faster by irritating blood vessels and making plaque more likely to stick.  This is also important when we talk about ‘medical management’ of plaque diseases.

Note: ‘Medical Management’ is a term that means exactly that – managing conditions (not curing or fixing) by use of medications.  The disease won’t go away but the thought is that medicines will slow the worsening of the conditioning.

People with history of vasculopathic disease:  these people should be screened because they already have a history of artery blockages – but people don’t always realize that carotid arteries and other arteries are essentially the same highway, so to speak.

This includes:

1. People with a history of Coronary artery disease (CAD) such as people with previous heart stents or bypass surgery.  In fact, one-third of people screened for carotid artery while awaiting bypass surgery (also called CABG) have significant carotid disease or stenosis.

2. People with blockages elsewhere: Renal artery stenosis (kidneys), peripheral artery disease (PAD) aka blockages in the legs, mesenteric artery disease (abdomen).

3. People with an abnormal eye exam or Amarosis fugax – this is basically a small stroke or mini-stroke to the eye.  Sometimes people develop symptoms (amarosis fugax – which is described as a sudden loss of vision, like a shade coming down over your eye).  Other times, the ophthalmologist sees a plaque in the artery to the eye on exam.

I’ll talk about more in my next post – and I am happy to answer condition related questions but not offer medical advice.  My legal eagles have a fit otherwise..

*as I have previously mentioned in Hidden Gem – it is vitally important patients know the generic names of their medications, along with dosages and administration information.

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I am re-posting yet another article discussing carotid stenting, and how it is misleadingly advertised as being a safer alternative to surgery to prospective patients.   This article comes from Heartwire, which is a statement in itself – as Heartwire is a cardiology journal aimed at the very interventionalist making their bread and very rich butter off of selling this higher risk procedure to their frightened or misinformed patients.. 

It isn’t headline news – this data has actually been out and published for several years now – but it’s taken this long to actually get the people performing the procedures to concede that carotid stenting is not all candy corns and rainbows…  But we’ll talk about this some more in my next post..  First, read the article yourself..

Article reposted below:

Higher stroke and mortality rates with carotid stenting over endarterectomy

December 20, 2010 | Michael O’Riordan

Boston, MA – After adjustment for symptom and risk status, carotid stenting results in higher rates of stroke and death when compared with surgical endarterectomy in the general US population, according to the results of a new study [1]. Mortality and stroke rates were significantly higher for carotid artery stenting than endarterectomy in high-risk and non-high-risk patients, report investigators.

“These data suggest that further careful analysis should be made to be certain that the efficacy demonstrated in randomized trials with carefully selected patients being treated by highly trained physicians is translated into effectiveness with similar results in broad general practice,” write Dr Kristina Giles (Beth Israel Deaconess Medical Center, Boston, MA) and colleagues in the December 2010 issue of the Journal of Vascular Surgery.

The Centers for Medicare and Medicaid Services (CMS) reimburses for carotid artery stenting in patients at high risk for carotid endarterectomy with symptomatic >70% stenosis. The reimbursement decision is based primarily on the results of the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial, which showed the interventional procedure cut 30-day rates of death, MI, and stroke by more than 50%. Other studies comparing the two approaches have shown mixed results. The latest Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) did show similar net outcomes with carotid artery stenting and carotid endarterectomy, but debate continues over which procedure should be performed in patients with symptomatic carotid disease.
Population-based data
The newest analysis comparing the two procedures was undertaken in 56 564 carotid-artery-stenting and 482 394 carotid-endarterectomy patients included in a database of the Agency for Healthcare Research and Quality. Past comparisons, according to Giles and colleagues, might have biased the results, mainly due to the CMS criteria, by overrepresenting high-risk and symptomatic patients in the stenting cohorts. Typically, high-risk criteria for endarterectomy include cardiac conditions such as recent MI, severe congestive heart failure, need for revascularization or valve repair within 30 days, and unstable angina, as well as end-stage kidney disease and pulmonary hypertension.

Overall, the combined end point of stroke or death was significantly higher among high- and low-risk patients, including among those with and without symptoms, undergoing carotid artery stenting compared with endarterectomy. Similarly, the mortality rate was 1.5% among high-risk patients, symptomatic and asymptomatic, who underwent stenting compared with 0.8% among high-risk patients treated with surgery, a statistically significant difference. Stroke rates among the high-risk patients were also significantly higher in the carotid-stenting treatment arm.

Death or stroke outcomes following carotid repair

Patient group Carotid artery stenting, n=56 564 (%) Carotid endarterectomy, n=482 394 (%) p
All patients 3.2 1.4 <0.001
High-risk 3.2 1.8 <0.001
Nonhigh-risk 3.1 1.0 <0.001
High-risk, symptomatic 14.4 6.9 <0.001
High-risk, asymptomatic 1.5 1.2 <0.05
Nonhigh risk, symptomatic 11.8 4.9 <0.001
Nonhigh risk, asymptomatic 1.8 0.6 <0.001

 

Outcomes following carotid repair assessed by symptom status

End point Carotid artery stenting, n=56 564 (%) Carotid endarterectomy, n=482 394 (%) p
Stroke or death      
Symptomatic patients 13.1 5.9 <0.001
Asymptomatic patients 1.6 0.9 <0.001
Mortality      
Symptomatic patients 6.0 1.8 <0.001
Asymptomatic patients 0.8 0.4 <0.001
Stroke      
Symptomatic patients 8.1 4.6 <0.001
Asymptomatic patients 1.0 0.6 <0.006

 

In a multivariate analysis, carotid stenting was associated with a 2.4-fold greater risk of death or stroke compared with endarterectomy, while symptom status, high-risk status, and procedures performed in earlier years were also associated with higher risks of death or stroke. These variables were also predictive of death and stroke alone.

Predictors of combined stroke or death

Variable Odds ratio (95% CI)
Carotid stent vs endarterectomy 2.4 (2.1-2.8)
Symptomatic status 6.8 (6.1-7.6)
High-risk status 1.6 (1.4-1.8)
Later year of procedure 0.9 (0.8-0.97)

 Note: this sentence seems to be out of place (below) but I didn’t want to edit the article, so here it is..)

Combined CABG and valve repair was performed in 3.9% of all carotid revascularization procedures, but the results showed stenting was not associated with an increased risk of stroke or death compared with carotid endarterectomy.

As Giles and colleagues point out in their paper, numerous studies comparing stenting with endarterectomy have shown conflicting results. The CMS decision to approve stenting as an alternative to the surgical approach is based on trials showing similar efficacy in high-risk patients, but the authors believe their newest results suggest that previous trials might not reflect current national outcomes.

“As more randomized trials define the efficacy of carotid artery stenting relative to carotid endarterectomy, additional population-based analyses with well-defined high-risk criteria are needed to be certain that acceptable results are obtainable in the general population,” write Giles and colleagues. “Further work is also needed to define the appropriate role of either revascularization method in those with specified high-risk criteria.”

Recent attempts to allow stenting in patients with lesser degrees of stenosis have been denied, however, as previously reported by heartwire.”

End of article..

The last sentences is pretty telling.. That means both insurance companies and the supervisory organizations for interventionalists are against the procedure – pretty harsh language for the field, but certainly made to sound mild here..   Of course, cardiologists are still reeling from two other recent scandals:

– the unnecessary stent medical trial of a well-known cardiologist (drawing more scrutiny to current practices)

– the unmasking of a fraudulent cardiologist who was actually on a speaking tour..

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