New Medtronic Heart Valve Threatened By Court Decision Reply

A legal injunction may severely limit the availability in the United States of Medtronic’s CoreValve device, which only received FDA approval earlier this year. The device received abundant praise recently when a large clinical trial demonstrated substantial advantages for CoreValve over traditional open-heart surgery.

The injunction is the latest episode in an ongoing patent war in which Edwards Lifesciences, which pioneered the field of transcatheter aortic valve replacement with its Sapien devices, has sought to hinder Medtronic from competing in the US and international markets.

Click here to read the full post on Forbes.

 

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The Uncertain Future Of A Once Highly Promising Device For Lowering Blood Pressure Reply

Following the spectacular crash and burn of the Symplicity HTN-3 trial at the American College of Cardiology two weeks ago, the future of renal denervation (RDN)– the once highly promising catheter technology that many thought would cure resistant hypertension– appears in doubt.

Although the device has not been approved in the US– and will not be approved without further clinical trials– in Europe and other places it remains on the market. So the questions about the technology’s future revolve around the future direction of research in the field and how the existing renal denervation market will be affected by the trial results.

Click here to read the full post on Forbes.

 

Aspirin and Clonidine Fail to Help Surgery Patients Reply

Heart attacks (myocardial infarctions) are among the most common and serious side effects of noncardiac surgery. An effective regimen to minimize this risk has been the subject of considerable debate in recent years. The controversy was recently exacerbated because the recommendation to use beta-blockers in this setting was based on research which has now been discredited. Substantial evidence against the use of perioperative beta blockers came from the original POISE trial.

Now a second POISE trial, the Perioperative Ischemic Evaluation 2 (POISE-2) trial, casts doubt on the value of two other proposed strategies to reduce death and MI in patients undergoing noncardiac surgery. Results of POISE-2 were presented at the American College of Cardiology meeting in Washington, DC and published simultaneously in two papers in the New England Journal of Medicine.

Click here to read the entire post on Forbes.

 

First TAVR Comparison Trial Favors Sapien XT Over CoreValve Reply

With two devices now approved for transcatheter aortic valve replacement (TAVR), the marketing battle has begun to win the hearts and minds of cardiologists. On Saturday at the ACC, Medtronic gained bragging rights showing the first mortality benefit for its CoreValve device. A similar improvement did not occur in the PARTNER trials with the Edwards Sapien device, but all the experts have warned against cross-trial comparisons. Now an actual randomized trial has emerged comparing the two platforms. The results favor the Sapien XT, but the size and scope of the trial mean that the discussion and debate will certainly continue.

Click here to read the entire post on Forbes.

 

 

Survival Advantage for TAVR Over Surgery in High-Risk Patients Reply

Transcatheter aortic valve replacement (TAVR), which has been slowly and cautiously entering the clinical arena, will probably get a big boost from a new trial showing a significant mortality advtange for TAVR over traditional surgery.

Results from the U.S. CoreValve High-Risk Study were presented at the American College of Cardiology in Washington, DC, and published simultaneously in the New England Journal of Medicine.

Click here to read the full post on Forbes.

 

 

No Benefit Found in First Real Test of Renal Denervation Reply

SYMPLICITY HTN-3, the eagerly awaited first rigorous test of renal denervation, shows that the real effect of the novel blood-pressure-lowering technology is dramatically lower than earlier expectations, which had been fueled by data from previous uncontrolled trials. Results of SYMPLICITY HTN-3 were presented at the American College of Cardiology conference in Washington, DC, and published simultaneously in the New England Journal of Medicine.

Click here to read the full post on Forbes.

 

What To Expect At The American College of Cardiology Meeting Reply

The ACC begins this Saturday in Washington, DC. Here’s a preview of some of the most highly-anticipated late-breaking clinical trials.

On Saturday morning at the opening session the world will finally learn more about the failure of Symplicity HTN-3, the Medtronic trial of renal denervation….

 Click here to read the entire post on Forbes.

 

US Patients More Likely Than English Patients To Receive Life-Saving Surgery Reply

Patients with a ruptured abdominal aortic aneurysm (rAAA)– a very serious life-threatening illness that occurs more often in elderly men– have better outcomes in the United States than in England, according to a new study published in the Lancet.

Researchers at the University of London compared hospital data from 11,799 rAAA patients in England with 23,838 rAAA patients in the U.S. They found that U.S. patients were more likely than English patients to have a procedure to repair the rAAA and to survive their hospital stay.

Click here to read the full post on Forbes.

French Surgeons Perform First Aortic Valve Surgery Without Opening The Chest Reply

Surgeons in France report that they have performed the first total endoscopic aortic valve replacement (TEAVR) in 2 human patients. Their paper has been published in the the Journal of Thoracic and Cardiovascular Surgery [subscription required].

The new procedure may enable surgeons to replace the aortic valve without opening the chest, though it will still require cardiopulmonary bypass and excision of the old valve. The key to the new procedure is the recent availability of sutureless aortic valve bioprostheses, in this case  the Medtronic 3f Enable bioprosthesis. In recent years these devices have allowed surgeons to develop “minimally invasive” surgical techniques. The new report is about the first surgical procedure in which the chest is not opened and the procedure is performed entirely through endoscopes.

Click here to read the entire post on Forbes.

 

What Ails Mt. Sinai Hospital Ails The Entire US Healthcare System 1

Bloomberg News article raises extremely troubling questions about policies and procedures that have made the Mt. Sinai hospital catheterization laboratory the busiest and most lucrative in New York City. It is unclear whether the specific allegations in the article will stand up to rigorous scrutiny but, say some experts, the ills identified in the article go far beyond Mt. Sinai and New York City and are actually endemic throughout the entire US healthcare system.

The most explosive charge in the story by David Armstrong, Peter Waldman and Gary Putka is that hospital physicians scheduled emergency room appointments for patients lacking insurance and coached them to say they were having symptoms of an acute coronary syndrome….

Click here to read the full post on Forbes.

Samin Sharma (Wikimedia Commons)

Samin Sharma (Wikimedia Commons)

4 Deaths Linked To Thoratec Heart System Reply

Thoratec Corporation today issued an urgent safety advisory about a serious problem with a key component of the HeartMate II LVAS system. The company said 4 patients had died and 5 patients had a loss of consciousness or other symptoms of hypoperfusion. The episodes occurred when patients and caregivers “experienced difficulties with the process of changing from a primary system controller to their backup system controller.”

The company said that 8 of the 9 events “occurred in patients who were converted to the Pocket Controller after being originally trained on an older model, the EPC System Controller….

Click here to read the full post on Forbes.

 

HeartMate II

 

 

Heart Societies Issue New Guidelines For Valve Disease Reply

The American Heart Association and the American College of Cardiology today released new practice guidelines [PDF] for the management of patients with valvular heart disease (VHD). Among its most notable features, the new document provides a new system of classification for VHD and lowers the threshold for interventions, including, for the first time, transcatheter as well as surgical interventions.

Click here to read the full post on Forbes.

 

Tooth Extraction Prior to Cardiac Surgery May Not Be a Good Idea Reply

People with an infected or abscessed tooth are at elevated risk for cardiovascular disease. They are at particular risk for developing a serious infection during surgery, including endocarditis, a potentially life-threatening infection of the heart. Because of this risk, in order to reduce the chance of infection, many patients undergo dental extraction prior to having a planned cardiac surgery. Now, however, a new paper published in The Annals of Thoracic Surgery raises the possibility that prophylactic dental extraction may be far more risky than previously thought.

Click here to read the full post on Forbes.

 

 

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.

 

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.

 

 

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 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.

 

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.

Dangerous Rapid Calcification Observed In Pediatric Patients After Aortic Valve Replacement Reply

Pediatric cardiac surgeons at Boston Children’s Hospital are warning the medical community about a potentially fatal problem in children and young adults who received a bioprosthetic valve manufactured by Sorin. The surgeons initially became concerned when a young asymptomatic patient died suddenly after her valve underwent rapid calcification, only 7 months after a routine followup echocardiogram found no signs of blockage.

Click here to read the entire post on Forbes.

 

FDA Grants Earlier Than Expected Approval For Medtronic’s CoreValve Reply

The FDA today approved Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis who are unable to undergo conventional open-heart surgery. The approval came several months ahead of expectations and without an FDA advisory panel meeting.

Click here to read the full post on Forbes.

CoreValve Family Sizing

Pivotal Medtronic Trial For ‘Breakthrough’ Blood Pressure Device Goes Down The Tubes Reply

The hypertension community woke up this morning to a large dose of reality with an announcement by Medtronic that the novel SYMPLICITY HTN-3 trial of its much-anticipated  renal denervation device had failed to meet its primary efficacy endpoint. Renal denervation has been widely touted as a breakthrough product that could dramatically lower blood pressure by as much as 30 mm Hg, allowing physicians to cure the most severe form of high blood pressure, resistant hypertension.

“SYMPLICITY HTN-3 met its primary safety endpoint related to the incidence of major adverse events one month following randomization and renal artery stenosis to six months,” said Deepak Bhatt, the co-principal investigator of the trial, in the Medtronic press release. “Importantly, however, the trial did not meet its primary efficacy endpoint.”

Click here to read the full post on Forbes.

 

Hospital Quality Helps Explain Some Of The Racial Disparities In Outcomes After CABG Reply

It has long been known that racial disparities exist in health care. A large body of research has found that nonwhite patients have worse outcomes than whites. But it has been difficult to understand the underlying reasons for these disparities.  Now a new study offers evidence that, at least in the case of bypass surgery, a significant but by no means complete portion of this disparity is due to decreased access among nonwhites to high quality hospitals.

In a paper published in JAMA Surgery, Govind Rangrass and colleagues analyzed Medicare data from 173,925 CABG patients. 8.6% of the study population was nonwhite. The mortality rate was 3.6% for the entire population. Nonwhite patients had a 34% increased risk of dying.

A key finding was that the third of hospitals that had the highest proportion of nonwhite patients (more than 17.7% nonwhite) also had the highest risk-adjusted mortality for both white and nonwhite patients (3.8% and 4.8%)….

Click here to read the full post on Forbes.

 

Cardiology in 2013: Like A Wrecking Ball 1

Perhaps I’m being overdramatic but I think  the best metaphor for the year in cardiology is Miley Cyrus on the wrecking ball.

The Guidelines Wrecking Ball: Like Hannah Montana guidelines are supposed to be boring and reliable.  But in 2013 the guidelines were more like Miley Cyrus. Like a wrecking ball, the NIH abandoned its long-entrenched and highly influential role in producing cholesterol and hypertension guidelines. Then the new ACC/AHA guidelines came along, abandoning tradition and targets and adopting a whole new approach. But the controversy didn’t go away. One easy prediction for 2014: we’ll see more debate about guidelines.

Click here to read the full post on Forbes.

Wrecking Ball

The New Guidelines

Miley Cyrus- Note: Cropped from larger image

The Old Guidelines

Boston Scientific May Face A Tough FDA Panel Reply

On Wednesday the FDA’s Circulatory System Devices Panel will once again review Boston Scientific’s Watchman left atrial appendage closure device for the prevention of stroke in atrial fibrillation patients (click here for the meeting materials). The panel will be the latest chapter in the long and contentious story of the Watchman. In 2010 the FDA issued a complete response letter and earlier this year a scandal broke out when the American College of Cardiology cancelled a prestigious late-breaking clinical trial presentation of the PREVAIL trial after the company broke an embargo by giving trial results to investors.

Wells Fargo analyst Lawrence Biegelsen predicts that the panel will be “contentious” but that ultimately the device will be approved next year. Although the trial missed one of its three c0-primary endpoints, the FDA reviewers emphasis on “the totality of the data” suggests a more benign FDA perspective, he writes.

One knowledgeable observer, Sanjay Kaul, who has served on several FDA panels, thinks the panel will indeed be contentious….

Click here to read the full post on Forbes.

 

Sanjay Kaul
Sanjay Kaul

 

Stents Lose In Comparisons With Surgery And Medical Therapy Reply

Despite the enormous increase in the use of stents in recent decades, there is little or no good evidence comparing their use to the alternatives of CABG surgery or optimal medical therapy in patients also eligible for these strategies. Now two new meta-analyses published in JAMA Internal Medicine provide new evidence that the alternatives to PCI remain attractive and that some of the growth in PCI may have been unwarranted.

Click here to read the full post on Forbes.