Tuesday, August 16, 2005
Cocoa fights heart disease
Aug 12 (HeartCenterOnline) - A cup of cocoa may actually be good for your heart, according to researchers in Great Britain.
Chocolate and cocoa have long been used as medicines. In fact, cocoa was originally marketed as a health tonic in the United States - and it appears there is an element of truth to the folk wisdom.
Cocoa is rich in flavonoids, which have been shown to inhibit blood clotting. This may reduce the risk of conditions caused by abnormal blood clotting, such as heart attack and stroke. Flavonoids are the same substance found in red wine, which also has been shown to have cardioprotective effects.
According to researchers, the discovery that flavonoids may help prevent blood clotting may lead to new medications, or "it may also mean that a nice hot cup of cocoa may take on new importance for people in high risk categories, " according to Dr. Denise O'Shaughnessy, who was quoted in a release describing the study.
The research was presented at the Congress of the International Society on Thrombosis & Haemostasis.
Copyright 2000-2005 (HealthCentersOnline)
Publish Date: August 12, 2005
Surgery extends mortality in cardiomyopathy
Aug 05 (HeartCenterOnline) - Patients with an abnormally thickened heart, or a condition known as hypertrophic cardiomyopathy, appear to live longer after having surgery, according to a new study.
Hypertrophic cardiomyopathy occurs when the walls of the heart, particularly the muscular wall that separates the chambers (the septum) are abnormally thickened. As a result, blood flow in the heart is reduced, causing symptoms such as shortness of breath, chest pain, dizziness or fainting. It severe cases, hypertrophic cardiomyopathy may cause sudden cardiac death. It is the most common cause of sudden death during athletic events.
Hypertrophic cardiomyopathy may be treated with a surgery called a myectomy, in which a portion of the thickened muscle is removed surgically. Numerous studies have shown that patients report feeling better after the surgery, but until now, no studies had been conducted showing a benefit to lifespan after myectomy.
Researchers from Mayo Clinic conducted a retrospective study of 1,337 patients evaluated at the clinic between 1983 and 2001. Of them, 228 had hypertrophic cardiomyopathy and had undergone myectomy. Another 228 had the condition but did not have surgery. The remaining patients had the condition, but suffered from no obstruction to their blood flow.
Researchers found that, within 10 years of diagnosis, almost 40 percent of patients who did not have surgery had died. By contrast, only 17 percent of patients who had undergone surgery had died. This death rate is the same as normal health patients, meaning that the mortality rate for myectomy patients was statistically the same as patients with non-obstructive hypertrophic cardiomyopathy or people in the general population of the same age and gender.
In a release describing the unpublished study, researchers remarked that patients undergoing myectomy can now be assured that the surgery has a good chance of extending their lifespans.
Copyright 2000-2005 (HealthCentersOnline)
Publish Date: August 05, 2005
Aug 12 (HeartCenterOnline) - A cup of cocoa may actually be good for your heart, according to researchers in Great Britain.
Chocolate and cocoa have long been used as medicines. In fact, cocoa was originally marketed as a health tonic in the United States - and it appears there is an element of truth to the folk wisdom.
Cocoa is rich in flavonoids, which have been shown to inhibit blood clotting. This may reduce the risk of conditions caused by abnormal blood clotting, such as heart attack and stroke. Flavonoids are the same substance found in red wine, which also has been shown to have cardioprotective effects.
According to researchers, the discovery that flavonoids may help prevent blood clotting may lead to new medications, or "it may also mean that a nice hot cup of cocoa may take on new importance for people in high risk categories, " according to Dr. Denise O'Shaughnessy, who was quoted in a release describing the study.
The research was presented at the Congress of the International Society on Thrombosis & Haemostasis.
Copyright 2000-2005 (HealthCentersOnline)
Publish Date: August 12, 2005
Surgery extends mortality in cardiomyopathy
Aug 05 (HeartCenterOnline) - Patients with an abnormally thickened heart, or a condition known as hypertrophic cardiomyopathy, appear to live longer after having surgery, according to a new study.
Hypertrophic cardiomyopathy occurs when the walls of the heart, particularly the muscular wall that separates the chambers (the septum) are abnormally thickened. As a result, blood flow in the heart is reduced, causing symptoms such as shortness of breath, chest pain, dizziness or fainting. It severe cases, hypertrophic cardiomyopathy may cause sudden cardiac death. It is the most common cause of sudden death during athletic events.
Hypertrophic cardiomyopathy may be treated with a surgery called a myectomy, in which a portion of the thickened muscle is removed surgically. Numerous studies have shown that patients report feeling better after the surgery, but until now, no studies had been conducted showing a benefit to lifespan after myectomy.
Researchers from Mayo Clinic conducted a retrospective study of 1,337 patients evaluated at the clinic between 1983 and 2001. Of them, 228 had hypertrophic cardiomyopathy and had undergone myectomy. Another 228 had the condition but did not have surgery. The remaining patients had the condition, but suffered from no obstruction to their blood flow.
Researchers found that, within 10 years of diagnosis, almost 40 percent of patients who did not have surgery had died. By contrast, only 17 percent of patients who had undergone surgery had died. This death rate is the same as normal health patients, meaning that the mortality rate for myectomy patients was statistically the same as patients with non-obstructive hypertrophic cardiomyopathy or people in the general population of the same age and gender.
In a release describing the unpublished study, researchers remarked that patients undergoing myectomy can now be assured that the surgery has a good chance of extending their lifespans.
Copyright 2000-2005 (HealthCentersOnline)
Publish Date: August 05, 2005
Tuesday, August 09, 2005
The September issue of CR has a notice about the recall of various Guidant defibrillators.
Luckily, my model isn't among them, but I had to do some searching to find that out - the recall lists everything by the model name, but my wallet card lists everything by model number, and I had to plow through several pages of Guidant's web site to find out the name of mine to match the number. (Model H115
CONTAK CD 2)
(here's the link: http://www.guidant.com/webapp/emarketing/mydevice/listing.jsp this allows you to select a model number from a drop-down box, and then when you go to that page, it lists the model name as well as number.)
Luckily, my model isn't among them, but I had to do some searching to find that out - the recall lists everything by the model name, but my wallet card lists everything by model number, and I had to plow through several pages of Guidant's web site to find out the name of mine to match the number. (Model H115
CONTAK CD 2)
(here's the link: http://www.guidant.com/webapp/emarketing/mydevice/listing.jsp this allows you to select a model number from a drop-down box, and then when you go to that page, it lists the model name as well as number.)
Monday, August 08, 2005
When a Heart Device Short-Circuits (NY Times)
August 7, 2005
When a Heart Device Short-Circuits
Defibrillators that shock a chaotically beating heart back to normal and
pacemakers that regulate a heart's rhythm have saved or improved the lives
of hundreds of thousands of people. But every so often one of these
implanted devices fails to work when it is desperately needed. The story of
how the Guidant Corporation, the nation's second-biggest maker of cardiac
devices, handled a flawed defibrillator provides a troubling glimpse into
the murky world of medical device regulation.
The problems came to light after a college student with a genetic heart
disease died in March while he was mountain biking in Utah. When Guidant
analyzed the device, it found that the unit had short-circuited. Worse yet,
the same model had short-circuited earlier in more than two dozen other
patients. Yet when the dead student's doctors asked Guidant officials how
they planned to get the word out, the officials said they saw no reason to.
It was only when The Times was about to publish an article by Barry Meier
exposing the problem in late May that the company issued an alert. The
article revealed that Guidant had known about the flaw for three years but
told neither doctors nor patients.
The company's justification for its reticence won't wash. Guidant said it
corrected the flaw in 2002 but saw no need to inform doctors because the
devices made before then were highly reliable and the surgical risk of
taking them out might outweigh the very low risk of failure. Incredibly, the
company kept selling the potentially flawed devices from inventory for
months after it began making improved versions. To this day it maintains
that all the devices are highly reliable, but surely there are few doctors
who would want to implant a device with a flaw that had been corrected in
more recent units. By failing to disclose the flaw publicly, the company
pre-empted a decision - whether to remove the flawed devices surgically -
that should be made by doctors and patients.
With the company facing heightened scrutiny from regulators and a steady
drumbeat of articles by Mr. Meier, Guidant has issued alerts or recalls on
20 models of defibrillators and pacemakers, comprising tens of thousands of
devices in all. For the future, the company, the Food and Drug
Administration, a heart rhythm medical society and the chairman of a Senate
committee are all pondering ways to increase the flow of information on
flaws in medical devices. It will be equally important to improve the
monitoring of these devices after implantation. Their generally reliable
performance must not obscure the fact that when they fail, the results can
be catastrophic.
* Copyright 2005 The New York Times Company
August 6, 2005
F.D.A. Will Not Release Some Data on Heart Devices
By BARRY MEIER
The Food and Drug Administration said yesterday that it would not release
information that it receives annually from the makers of heart devices
detailing how often and why products fail. The agency called such data a
corporate trade secret.
The F.D.A. took its position in response to a Freedom of Information Act
request from The New York Times, which had sought annual reports filed by
the Guidant Corporation in connection with a defibrillator, the Ventak Prizm
2 DR. From 2000 to 2002, Guidant made thousands of the devices, some of
which had electrical flaws that caused them to short-circuit. In March, a
college student with a flawed device died of cardiac arrest.
The agency's position may put it at odds with Senator Charles E. Grassley,
Republican of Iowa and chairman of the Senate Finance Committee. Senator
Grassley recently wrote to the commissioner of the F.D.A., Dr. Lester M.
Crawford, asking the agency to explain why it did not make product data from
device makers' annual reports publicly available on a regular basis.
Senator Grassley, who last year held hearings on the agency's post-marketing
scrutiny of drugs like Vioxx, said yesterday that he was disappointed by the
latest decision.
"The F.D.A. needs to find reasons to make information public rather than
working overtime to withhold findings that the public deserves to know
about," he said. "Amid the scrutiny of the last year, the F.D.A. has
acknowledged that the public wants and needs to know, but so far the
agency's actions haven't matched its words."
Under little-known F.D.A. regulations, the makers of defibrillators and
pacemakers must provide detailed data each year to the agency, including the
frequency of failure in individual models, the cause of such failures and
the number of deaths and injuries.
A defibrillator sends an electrical charge to the heart to interrupt a
chaotic and potentially fatal rhythm. A pacemaker regulates a heart that is
beating too fast or too slowly.
The product-performance data submitted to the F.D.A. by manufacturers is
more detailed than that they provide to doctors, industry officials said.
The F.D.A. - in responding to a Times request for all annual reports filed
by Guidant in connection with the Ventak Prizm 2 DR - said that it would not
release the product performance data for that device and similar ones made
by Guidant.
The F.D.A. said yesterday that such information, be it from Guidant or
another maker, constituted confidential trade information.
"This information is a trade secret and exempt from release," an agency
official, Joy B. Lazaroff, wrote in an e-mail message.
An F.D.A. spokeswoman, Julie Zawisza, said in June that while the agency did
not make such filings public on a regular basis, it might do so if a Freedom
of Information request was filed.
In addition to the annual reports, makers are also required to file reports
with the F.D.A. on possible product failures, including those related to
potential patient injuries.
A review of the reports filed by Guidant that the F.D.A. recently placed on
its database showed that both the frequency of electrical failures of the
Ventak Prizm 2 DR and its consequences for heart patients were increasing
before the March death of a college student who had a flawed device.
The review also showed that about 14 of the 28 known failures occurred from
January 2004 to this March. In addition, both the death of the student,
Joshua Oukrop, as well as most patient injuries potentially related to the
device's flaw took place during the same period, the filings show.
In 2002, Guidant executives discovered that the device was prone to
short-circuiting, which would render it useless. The company fixed the
problem in 2002 but did not alert doctors for three years until it became
aware that the problem would be disclosed in other public forums. In
addition, Guidant kept selling older versions of the device even as it was
selling an improved version in which the electrical flaw was eliminated.
Under F.D.A. regulations, a company is required to analyze the risks posed
by a device and make an assessment as to how to respond. A manufacturer must
keep records of how it made such assessments on file for review by F.D.A.
officials. Specialists on medical-device regulation said a company was
supposed to regularly review its course of action and possibly revise it if
events, like an increasing rate of product failure reports, warranted it.
Executives of Guidant, which is based in Indianapolis, have said that the
company made all required filings with the F.D.A. regarding individual
reports of device failures and told the agency in 2003 about the
manufacturing change that fixed the flaw. Companies, however, do not have to
file risk assessments with the F.D.A.
A spokesman for Guidant, Steven Tragash, declined to respond to written
questions on the frequency of the risk assessments of the Prizm 2 DR,
including if one had been done in March when Mr. Oukrop died and another
heart patient nearly died. The role of the device in both incidents is not
clear.
Mr. Tragash declined to make the chief executive, Ronald W. Dollens, or the
head of its heart device unit, R. Frederick McCoy Jr., available to be
interviewed. Guidant also did not respond to written questions about when,
or if, Mr. Dollens and Mr. McCoy became involved in discussions on whether
to issue an alert about the Prizm 2 DR to doctors.
In December, Guidant, which derives about half of its revenue from
defibrillator sales, agreed to be acquired by Johnson & Johnson in a deal
worth $25.4 billion.
The exact number of problem reports filed by Guidant each year in connection
with the Prizm DR could not be determined because the reason for a device's
failure is not always readily apparent from the language. But the filings
indicate that Guidant made 2 reports in 2002 about short-circuiting in the
Prizm 2 DR; some 8 such reports in 2003; some 11 reports in 2004; and 4 in
the first three months of this year.
* Copyright 2005 The New York Times Company
August 7, 2005
When a Heart Device Short-Circuits
Defibrillators that shock a chaotically beating heart back to normal and
pacemakers that regulate a heart's rhythm have saved or improved the lives
of hundreds of thousands of people. But every so often one of these
implanted devices fails to work when it is desperately needed. The story of
how the Guidant Corporation, the nation's second-biggest maker of cardiac
devices, handled a flawed defibrillator provides a troubling glimpse into
the murky world of medical device regulation.
The problems came to light after a college student with a genetic heart
disease died in March while he was mountain biking in Utah. When Guidant
analyzed the device, it found that the unit had short-circuited. Worse yet,
the same model had short-circuited earlier in more than two dozen other
patients. Yet when the dead student's doctors asked Guidant officials how
they planned to get the word out, the officials said they saw no reason to.
It was only when The Times was about to publish an article by Barry Meier
exposing the problem in late May that the company issued an alert. The
article revealed that Guidant had known about the flaw for three years but
told neither doctors nor patients.
The company's justification for its reticence won't wash. Guidant said it
corrected the flaw in 2002 but saw no need to inform doctors because the
devices made before then were highly reliable and the surgical risk of
taking them out might outweigh the very low risk of failure. Incredibly, the
company kept selling the potentially flawed devices from inventory for
months after it began making improved versions. To this day it maintains
that all the devices are highly reliable, but surely there are few doctors
who would want to implant a device with a flaw that had been corrected in
more recent units. By failing to disclose the flaw publicly, the company
pre-empted a decision - whether to remove the flawed devices surgically -
that should be made by doctors and patients.
With the company facing heightened scrutiny from regulators and a steady
drumbeat of articles by Mr. Meier, Guidant has issued alerts or recalls on
20 models of defibrillators and pacemakers, comprising tens of thousands of
devices in all. For the future, the company, the Food and Drug
Administration, a heart rhythm medical society and the chairman of a Senate
committee are all pondering ways to increase the flow of information on
flaws in medical devices. It will be equally important to improve the
monitoring of these devices after implantation. Their generally reliable
performance must not obscure the fact that when they fail, the results can
be catastrophic.
* Copyright 2005 The New York Times Company
August 6, 2005
F.D.A. Will Not Release Some Data on Heart Devices
By BARRY MEIER
The Food and Drug Administration said yesterday that it would not release
information that it receives annually from the makers of heart devices
detailing how often and why products fail. The agency called such data a
corporate trade secret.
The F.D.A. took its position in response to a Freedom of Information Act
request from The New York Times, which had sought annual reports filed by
the Guidant Corporation in connection with a defibrillator, the Ventak Prizm
2 DR. From 2000 to 2002, Guidant made thousands of the devices, some of
which had electrical flaws that caused them to short-circuit. In March, a
college student with a flawed device died of cardiac arrest.
The agency's position may put it at odds with Senator Charles E. Grassley,
Republican of Iowa and chairman of the Senate Finance Committee. Senator
Grassley recently wrote to the commissioner of the F.D.A., Dr. Lester M.
Crawford, asking the agency to explain why it did not make product data from
device makers' annual reports publicly available on a regular basis.
Senator Grassley, who last year held hearings on the agency's post-marketing
scrutiny of drugs like Vioxx, said yesterday that he was disappointed by the
latest decision.
"The F.D.A. needs to find reasons to make information public rather than
working overtime to withhold findings that the public deserves to know
about," he said. "Amid the scrutiny of the last year, the F.D.A. has
acknowledged that the public wants and needs to know, but so far the
agency's actions haven't matched its words."
Under little-known F.D.A. regulations, the makers of defibrillators and
pacemakers must provide detailed data each year to the agency, including the
frequency of failure in individual models, the cause of such failures and
the number of deaths and injuries.
A defibrillator sends an electrical charge to the heart to interrupt a
chaotic and potentially fatal rhythm. A pacemaker regulates a heart that is
beating too fast or too slowly.
The product-performance data submitted to the F.D.A. by manufacturers is
more detailed than that they provide to doctors, industry officials said.
The F.D.A. - in responding to a Times request for all annual reports filed
by Guidant in connection with the Ventak Prizm 2 DR - said that it would not
release the product performance data for that device and similar ones made
by Guidant.
The F.D.A. said yesterday that such information, be it from Guidant or
another maker, constituted confidential trade information.
"This information is a trade secret and exempt from release," an agency
official, Joy B. Lazaroff, wrote in an e-mail message.
An F.D.A. spokeswoman, Julie Zawisza, said in June that while the agency did
not make such filings public on a regular basis, it might do so if a Freedom
of Information request was filed.
In addition to the annual reports, makers are also required to file reports
with the F.D.A. on possible product failures, including those related to
potential patient injuries.
A review of the reports filed by Guidant that the F.D.A. recently placed on
its database showed that both the frequency of electrical failures of the
Ventak Prizm 2 DR and its consequences for heart patients were increasing
before the March death of a college student who had a flawed device.
The review also showed that about 14 of the 28 known failures occurred from
January 2004 to this March. In addition, both the death of the student,
Joshua Oukrop, as well as most patient injuries potentially related to the
device's flaw took place during the same period, the filings show.
In 2002, Guidant executives discovered that the device was prone to
short-circuiting, which would render it useless. The company fixed the
problem in 2002 but did not alert doctors for three years until it became
aware that the problem would be disclosed in other public forums. In
addition, Guidant kept selling older versions of the device even as it was
selling an improved version in which the electrical flaw was eliminated.
Under F.D.A. regulations, a company is required to analyze the risks posed
by a device and make an assessment as to how to respond. A manufacturer must
keep records of how it made such assessments on file for review by F.D.A.
officials. Specialists on medical-device regulation said a company was
supposed to regularly review its course of action and possibly revise it if
events, like an increasing rate of product failure reports, warranted it.
Executives of Guidant, which is based in Indianapolis, have said that the
company made all required filings with the F.D.A. regarding individual
reports of device failures and told the agency in 2003 about the
manufacturing change that fixed the flaw. Companies, however, do not have to
file risk assessments with the F.D.A.
A spokesman for Guidant, Steven Tragash, declined to respond to written
questions on the frequency of the risk assessments of the Prizm 2 DR,
including if one had been done in March when Mr. Oukrop died and another
heart patient nearly died. The role of the device in both incidents is not
clear.
Mr. Tragash declined to make the chief executive, Ronald W. Dollens, or the
head of its heart device unit, R. Frederick McCoy Jr., available to be
interviewed. Guidant also did not respond to written questions about when,
or if, Mr. Dollens and Mr. McCoy became involved in discussions on whether
to issue an alert about the Prizm 2 DR to doctors.
In December, Guidant, which derives about half of its revenue from
defibrillator sales, agreed to be acquired by Johnson & Johnson in a deal
worth $25.4 billion.
The exact number of problem reports filed by Guidant each year in connection
with the Prizm DR could not be determined because the reason for a device's
failure is not always readily apparent from the language. But the filings
indicate that Guidant made 2 reports in 2002 about short-circuiting in the
Prizm 2 DR; some 8 such reports in 2003; some 11 reports in 2004; and 4 in
the first three months of this year.
* Copyright 2005 The New York Times Company
Thursday, August 04, 2005
Cholesterol Drugs & Heart Failure
A common cholesterol-reducing drug may lower the risk of death from heart failure. Read the complete article: Statin therapy lowers mortality in heart failure. For more information, visit HeartCenterOnline's Cholesterol Center or Heart Failure Center. Or, view all Cholesterol News or Heart Failure News.
You can also check out the Heart Failure Quiz.
And other articles:
Topiramate lowers weight and blood pressure
Statin therapy lowers mortality in heart failure
I've been doing OK since I arrived in Maryland; it's been 10-15 degrees cooler than in Austin except for the last 2 weeks. Right now it's as hot and humid as Austin. But even so it doesn't feel quite as bad, because there isn't heat soaked into the ground from months and months of temperatures near 100 degrees. There are still lots of shady trees, and the grass is green, which keeps the ground temperature cooler.
My big worry right now is that my insurance, from the Employees Retirement System of Texas, still hasn't told me what my coverage is for finding a new cardiologist up here, so I don't have a doctor. My old doctors back in Austin are not going to authorize my prescription refills in Maryland forever, so I really need to find a family doctor and a cardiologist soon, and I really should find an electrophysiologist as well, since it'll be time for another ICD/pacemaker reading/check-up in another month or so. So I guess I need to phone ERS and hassle them a bit, to find out what my coverage limits are now that I'm "out of area." (For that matter, I still haven't found anyone to cut my hair, either, and that needs doing, but at least I don't have to wait on insurance for that! Moving certainly discombobulates one's life, even when it's overall for the better.)
A common cholesterol-reducing drug may lower the risk of death from heart failure. Read the complete article: Statin therapy lowers mortality in heart failure. For more information, visit HeartCenterOnline's Cholesterol Center or Heart Failure Center. Or, view all Cholesterol News or Heart Failure News.
You can also check out the Heart Failure Quiz.
And other articles:
Topiramate lowers weight and blood pressure
Statin therapy lowers mortality in heart failure
I've been doing OK since I arrived in Maryland; it's been 10-15 degrees cooler than in Austin except for the last 2 weeks. Right now it's as hot and humid as Austin. But even so it doesn't feel quite as bad, because there isn't heat soaked into the ground from months and months of temperatures near 100 degrees. There are still lots of shady trees, and the grass is green, which keeps the ground temperature cooler.
My big worry right now is that my insurance, from the Employees Retirement System of Texas, still hasn't told me what my coverage is for finding a new cardiologist up here, so I don't have a doctor. My old doctors back in Austin are not going to authorize my prescription refills in Maryland forever, so I really need to find a family doctor and a cardiologist soon, and I really should find an electrophysiologist as well, since it'll be time for another ICD/pacemaker reading/check-up in another month or so. So I guess I need to phone ERS and hassle them a bit, to find out what my coverage limits are now that I'm "out of area." (For that matter, I still haven't found anyone to cut my hair, either, and that needs doing, but at least I don't have to wait on insurance for that! Moving certainly discombobulates one's life, even when it's overall for the better.)
