Study Raises Questions About Transfusions In PCI Patients Reply

A very large observational study raises important questions about the role of transfusions in PCI patients in the US.

In a study published in JAMA, researchers from Duke and Yale analyzed data from more than 2.25 million percutaneous coronary intervention (PCI) procedures at more than 1,400 hospitals. The data came from the CathPCI Registry, a large ongoing study that includes  a significant proportion of all cardiac catheterization procedures in the US.

The overall transfusion rate was 2.14% but there was a very wide variation in transfusion practice patterns, ranging from 0 to 13%….

….

Click here to read the full post on Forbes.

 

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FDA Approves New Catheter For Treatment Of Atrial Fibrillation Reply

The FDA has granted marketing approval for the Thermocool Smarttouch ablation catheter for use in patients with drug-resistant paroxysmal atrial fibrillation (AF), sustained monomorphic ischemic ventricular tachycardia and Type I atrial flutter. The device is manufactured by Biosense Webster, a Johnson & Johnson company.

Click here to read the full post on Forbes.

 

 

Vitamin Supplements Come Up Short Once Again 1

Once again the U.S. Preventive Services Task Force (USPSTF) has concluded that there is no good evidence to support the routine use of multivitamins or most individual or combination vitamins by healthy adults to prevent cardiovascular disease or cancer.

The USPSTF also recommended against the use of two specific vitamins — beta-carotene and vitamin E. Beta-carotene has been linked to a significant increase in the risk for lung cancer among smokers, while “a large and consistent body of evidence has demonstrated that vitamin E supplementation has no effect on cardiovascular disease, cancer, or all-cause mortality.”

For other vitamins or multivitamins, the task force found few significant harms, though they said the evidence was insufficient to allow definitive assessments of the risks and benefits.

Click here to read the full post on Forbes.

Lower Blood Pressure Found In Vegetarians Reply

A new study provides the strongest evidence yet that a vegetarian diet is strongly associated with lower blood pressure. Although various health benefits of a vegetarian diet have often been proposed, a rigorous examination of the effect on blood pressure has not been previously performed.

In a paper published in JAMA Internal Medicine, Japanese researchers analyzed data from 7 clinical trials, including 311 participants, and 32 observational studies, including 21,604 participants….

Click here to read the full post on Forbes.

 

 

 

 

Wall Street Journal Op-Ed On Sham Surgery Gets It Wrong Reply

In an op-ed piece in the Wall Street Journal Scott Gottlieb, a former FDA official under George W. Bush, argues that the FDA should stop requiring medical device companies to use sham procedures when they test certain new products. To support his argument he uses the example of renal denervation, a once highly promising new technology for lowering blood pressure. Unfortunately, Gottlieb extracts exactly the wrong lesson from this story, because the renal denervation story is a perfect example of why sham procedures can be both necessary and more ethical than any alternative.

At first glance it’s hard to disagree with Gottlieb. The idea that patients would receive an invasive surgical procedure that could do no good appears abhorrent. “Research that introduces harm or risk with no opportunity for benefit would seem to conflict with the principles governing research on humans,” writes Gottlieb.

But the same exact words could and should be used to describe medical devices with no proven benefit. In such cases, however, instead of the relatively small number of patients potentially exposed to harm in clinical studies, the number of patients exposed to harm in the real world may be larger by many orders of magnitude.

Let’s examine this issue using the same example used by Gottlieb: renal denervation….

Click here to read the full post on Forbes.

 

Newly Elected President Of Institute of Medicine Is On The Pepsico Board Of Directors 4

Earlier today I reported the news that Victor Dzau, the chancellor for health affairs at Duke University and the CEO of the Duke University Health System, would become the next president of the Institute of Medicine. But I  failed to remember that I had written about Dzau several years ago. I think it will be of interest to many observers that Dzau currently serves on the Board of Directors of Pepsico. I’ve asked the IOM for a comment about this.

Here’s what I wrote in 2010 about Dzau.

Victor Dzau Leaving Duke To Head The Institute Of Medicine Reply

Cardiologist Victor Dzau will leave his positions as the chancellor for health affairs at Duke University and the CEO of the Duke University Health System to become the next president of the Institute of Medicine. He will replace Harvey Fineberg, who has been the IOM president for the last 12 years.

“I am humbled and honored to be selected to lead the IOM at a time of unprecedented opportunities and challenges in health, health care, and biomedical sciences,” said Dzau in a statement from the IOM. “Harvey Fineberg has been an exceptional leader of the IOM, and I am committed to building on his outstanding work and advancing the impact of the IOM on the nation and globally.”

Before moving to Duke almost a decade ago Dzau was the chair of the department of medicine and director of research at Brigham and Women’s Hospital and the Hersey Professor of the Theory and Practice of Physic (Medicine) at Harvard Medical School. Prior to that he had been the chair of the department of medicine at Stanford University. In his career as a researcher Dzau played a key role in understanding the renin-angiotensin-aldosterone system.

Robert Califf, director of the Duke Translational Medicine Institute, sent the following comment:

This appointment is a real honor for Victor and for Duke. During his tenure, the instituiton has grown into an academic health and science system, made numerous scientific contributions and thrived financially.

Dzau was first elected to the IOM in 1998. He will begin his six-year term as president on July 1.

 

Artery Zapping Little Better Than Drugs In Atrial Fibrillation Patients Reply

Atrial fibrillation is the most common heart rhythm disorder. Although AF is not as lethal as some other arrhythmias, AF patients are at high risk for stroke and other serious complications. AF is also very difficult to treat. Although drugs are ineffective in a large percentage of patients, drugs are considered first line therapy in current guidelines.

Zapping arteries with electric energy, or radio frequency ablation (RFA) was originally hoped to be a cure for AF. Those earlier hopes have been dashed but some experts have held out hope that RFA therapy would be better than drug therapy as initial treatment.

Now a new trial offers scant support for earlier use of radio frequency ablation to treat atrial fibrillation.

Some 127 patients with paroxysmal AF were randomized to antiarrhythmic therapy or RFA as initial treatment in the RAAFT-2 trial…

Click here to read the full post on Forbes.

 

No, An Apple Device Won’t Tell You If You’re Having A Heart Attack 2

No one knows for sure but Apple appears to be strongly interested in adding medical applications and technologies to its current and future products. We know that Apple has patented a heart sensor that could be incorporated in a future iPhone or iWatch, though it seems more likely that it would be used for security rather than health purposes. We also know that top Apple executives have met with FDA commissioner Margaret Hamburg and top FDA device regulators, though the details of their discussion have not been disclosed.

But one new report on SF Gate is almost certainly wrong: an Apple device won’t be able to tell you if you’re about to have a heart attack.

 Apple is exploring ways to measure noise “turbulence” as it applies to blood flow. The company wants to develop software and sensors that can predict heart attacks by identifying the sound blood makes as it tries to move through an artery clogged with plaque, the source said.

Click here to read the full post on Forbes.

 

FDA Once Again Rejects New Indication For Rivaroxaban Reply

The third time wasn’t the charm. The FDA today turned turned down– for the third time– the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke or death. In addition, the FDA– for the second time– turned down the sNDA for rivaroxaban in the same population for the reduction of stent thrombosis.

Click here to read the full post on Forbes.

 

FDA Advisory Panel Recommends Against Approval Of Cangrelor Reply

The FDA’s Cardiovascular and Renal Drugs Advisory Committee today recommended against the approval of cangrelor, the investigational new antiplatelet drug from the Medicines Company. In a 7-2 vote the panel first rejected an indication  for the reduction of thrombotic cardiovascular events including stent thrombosis in patients undergoing PCI.

The panel also voted unanimously to reject a second indication…

Click here to read the full post on Forbes.

 

 

FDA Investigating Heart Failure Risk Linked To Onglyza Reply

The FDA said today that it was conducting an investigation of a possible increased risk for heart failure associated with the diabetes drug saxagliptin. Saxagliptin is marketed by AstraZeneca as Onglyza and Kombiglyze XR. (AstraZeneca recently completed the purchase of all rights to the drug from its manufacturer, BristolMyers-Squibb.)

The investigation stems from findings from the cardiovascular outcomes trial SAVOR-TIMI 53 trial  in which more than 16,000 type 2 diabetics were randomized to the DPP-4 inhibitor saxagliptin or placebo.

Click here to read the full post on Forbes.

 

 

 

 

FDA Reviewers Deliver Split Opinion On The Medicines Company’s Cangrelor Reply

FDA reviewers presented two dramatically different views of The Medicines Company’s investigational new drug cangrelor. One reviewer says the drug should not be approved without a new trial and even states that the CHAMPION trials “were conducted unethically” and should not be approved “on that fact alone.”  But two other reviewers recommend approval.

Click here to read the full post on Forbes.

 

Leading European Cardiologist Accused Of Plagiarism Reply

Thomas Lüscher, the editor of the European Heart Journal and one of the most prominent cardiologists in Europe, has been accused of plagiarism. An irony in the case is that  Lüscher has taken a strong public position against scientific misconduct of all sorts, including plagiarism.

Click here to read the full post on Forbes.

 

This Blog Is ‘Not Suitable For Dissemination Through The Internet’ 1

The editors of the prestigious European Heart Journal have decided that this blog, or at least one recent post, “is “not suitable for dissemination through the internet.”

I beg to differ.

In an EHJ editorial, Is the panic about beta-blockers in perioperative care justified?the authors, the editors of the journal, led by editor-in-chief Thomas Lüscher, repeatedly criticize a post I wrote a few weeks ago with an intentionally provocative headline, “Medicine Or Mass Murder? Guideline Based on Discredited Research May Have Caused 800,000 Deaths In Europe Over The Last 5 Years.”

Their editorial begins:

Controversial issues need proper discussion, both in science and clinical medicine. Sometimes the interpretation of the available data is complex and not suitable for dissemination through the internet.1

That reference at the end refers to my earlier article.

Click here to read the full post on Forbes.

 

Censorship
Censorship (Photo credit: IsaacMao)

Eric Topol To Be AT&T’s Chief Medical Advisor Reply

AT&T announced today that it had appointed cardiologist Eric Topol as its Chief Medical Advisor. The company said he will “impact the design, development and delivery of AT&T’s healthcare IT solutions, connecting the healthcare ecosystem to enhance health outcomes and care delivery processes for patients and their caregivers.”

Click here to read the full post on Forbes.

 

 

Eric Topol

Blood Pressure Trajectory Over 25 Years Predicts Atherosclerosis Risk Reply

Everyone knows that blood pressure is one of the most important measurements of cardiovascular risk. Less well known is that most studies of blood pressure have relied on single or isolated measurements of blood pressure. Few studies have even attempted to examine the significance of blood pressure patterns over a long period of time.

Now, in a paper published in JAMA, researchers present an analysis of data from 3442 adults who participated in the long-term CARDIA study. Study participants were 18-30 years of age at baseline and had multiple blood pressure measurements over the course of the study. After 25 years, they had a CT scan that measured their coronary artery calcium (CAC) score.

Click here to read the full post on Forbes.

 

Blood pressure check
Blood pressure check (Photo credit: Army Medicine)

 

 

More Guideline Controversy: Blood Pressure Expert Decries ‘Political Correctness’ Reply

Now add “political correctness” to the long list of criticisms directed against the recent publication of new and updated cardiovascular guidelines. One leading hypertension expert writes that the authors of the recent AHA/ACC/CDC Science Advisory on blood pressure control were chosen not for their expertise but for political expediency.

Click here to read the full post on Forbes.

Confusion
Confusion (Photo credit: quinn.anya)

The Not So Sweet Facts About Sugar 1

A new study offers a broad overview of the use of sugar in the US diet and its consequent health implications. The good news is that the growth in sugar intake appears to have stopped and may even have slightly declined. The bad news is that people still consume way too much sugar and that that sugar is killing them.

In a paper published in JAMA Internal Medicine, Quanhe Yang, from the Centers for Disease Control and Prevention, and colleagues analyze data about sugar use and its health effects from the NHANES (National Health and Nutrition Examination Survey) studies.

Click here to read the full story on Forbes. 

English: Macro photograph of a pile of sugar (...
English: Macro photograph of a pile of sugar (saccharose) (Photo credit: Wikipedia)

FDA Evaluating Safety Of Testosterone Reply

The FDA said today that it was evaluating the cardiovascular safety of testosterone products. The investigation is prompted by two recent published studies that found a significant increase in cardiovascular events in men who received testosterone therapy.

Click here to read the full post on Forbes.

Original illustration by Max Husten

 

American College of Cardiology Announces Late-Breaking Clinical Trials Reply

The American College of Cardiology announced the lineup of late-breaking clinical trials for its upcoming annual meeting in Washington, DC. The opening session will include the most eagerly anticipated trials– the main results of Symplicity HTN-3 and the  comparison of Corevalve and surgery in high risk patients. Subsequent sessions will include several phase 3 trials of  PCSK9 inhibitors. Here is the complete list of trials:

Click here to read the full post on Forbes.

 

Johnson & Johnson Will Share Clinical Trial Data 1

In a major victory for advocates of open access to data from clinical trials, Johnson & Johnson today announced that it will make all of its clinical trial data available to outside researchers. The company said that the Yale University Open Data Access (YODA) Project will serve as an independent third party “to review requests from investigators and physicians seeking access to anonymized clinical trials data.”

The company said that this program “is the first time any company has collaborated with a completely independent third party to review and make decisions regarding every request for clinical data.”

Click here to read the full post on Forbes.

 

Problems Persist Despite Gains In Oral Anticoagulant Use Reply

Although significant progress has been made in recent years, a new survey from the European Society of Cardiology finds that there are still too many atrial fibrillation patients who are not taking the best medications to reduce their elevated risk of stroke. Many elderly patients are not receiving oral anticoagulants and overall too many patients are still taking aspirin, despite the fact that it is not recommended for this group of patients.

In a paper published in the American Journal of Medicine, Gregory YH Lip and colleagues analyzed data from more than 3,100 patients surveyed in the Euro Observational Research Programme on Atrial Fibrillation from February 2012 to March 2013.

Click here to read the entire post on Forbes.

 

European Setback For Novartis Heart Failure Drug Reply

European regulators have dealt a setback to a novel heart failure drug under development by Novartis.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended against giving market approval to serelaxin (Reasanz) for the treatment of acute heart failure. The recommendation is based largely on the committee’s analysis of the RELAX-AHF trial, which was published in the Lancet in 2012. Here is CHMP’s explanation for their decision:

Click here to read the full post on Forbes.

 

 

 

Stent Remains Available Despite Trial Showing Dangers 1

A leading critic says that the FDA has been remiss for not removing a stent from the market although strong evidence exists that its use leads to more deaths and strokes.

Now, in a paper published in BMJ, a group of physicians led by Rita Redberg say that by not removing Wingspan from the market the FDA is shirking its “responsibility to protect the public’s health.”

Click here to read the full post on Forbes.