High-Sensitivity Troponin Test Could Identify Low Risk Chest Pain Patients In The ED Reply

Approximately 15-20 million people in Europe and the United States go to the emergency department every year with chest pain. Many can be discharged early if they are not having an acute coronary syndrome. A large new single-center observational study, presented at the American College of Cardiology meeting in Washington, DC and published simultaneously in the Journal of the American College of Cardiology, provides fresh evidence that high-sensitivity cardiac troponin T (hs-cTnT) may be useful in helping identify chest pain patients in the emergency department who do not need to be admitted to the hospital.

Click here to read the full post on Forbes.

 

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MADIT-CRT Long-Term Follow-Up Shows Survival Benefit with CRT-D Reply

MADIT-CRT was an influential trial that showed a reduction in heart failure complications — but not mortality — when cardiac resynchronization therapy (CRT) was added to an implantable defibrillator in patients with mild heart failure who also had left bundle-branch block (LBBB). Patients in the trial were followed for 2.4 years, raising questions about the long-term effects of CRT. Now, a second look at 854 patients who participated in a follow-up study, presented at the American College of Cardiology and published in the New England Journal of Medicine, suggests that over the long term, CRT may save lives in this population. MADIT-CRT was sponsored by Boston Scientific.

Click here to read the full post on Forbes.

 

 

 

MADIT-CRT Long-Term Follow-Up Shows Survival Benefit with CRT-D

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.

 

New Atrial Fibrillation Guideline Supports New Drugs And Devices Reply

A new guideline for atrial fibrillation (AF) was released on Friday by the American Heart Association, the American College of Cardiology, and the Heart Rhythm Society. Among other features, the 2014 Guideline for the Management of Patients With Atrial Fibrillation incorporates important new information about the new oral anticoagulants and catheter ablation for the treatment of AF symptoms.

Click here to read the entire story on Forbes.

 

Guest Post: How Sure Can We Be About Optisure? 2

Editor’s Note: The following guest post is published with the permission of its author, Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

How Sure Can We Be About Optisure?

by Edward J. Schloss, MD

On March 24, St. Jude Medical announced the global launch of the Optisure family of ICD leads. It’s been a while since a new ICD lead was launched, and I’m probably not the only one who was caught by surprise. I’d like to explore why this approval is important for the ICD community. First, a brief history of ICD leads from St. Jude.

FROM RIATA TO DURATA

St. Jude Medical developed its own line of ICD leads after it purchased the former ICD vendor Ventritex in 1996. The first-generation Riata lead, approved in 2001, was succeeded by the Riata ST line in 2006. These leads were distinguished, in part, by their thin diameter, permitting implantation through a 7 Fr introducer sheath. In that era, implanting physicians’ interest in a thin lead was very strong. Even the high-profile failure of the 7 Fr Medtronic Fidelis ICD lead didn’t seem to dampen that enthusiasm.

Both of St. Jude’s Riata lead families later developed problems. Reports of subacute perforation soon after implant in the Riata ST line arose in the late 2000s. A year or two later, the internal core structure of both the Riata and Riata ST leads was discovered to break down in 25% and 10%, respectively, of these leads, as evident on fluoroscopic evaluation — a process called externalization. This problem, along with noted increased electrical failures of this lead, prompted an FDA class I recall of both product lines in December 2011, in addition to intense scrutiny and discussion in the lay press, investor press, blogosphere, and academic literature.

By the time the Riata and Riata ST leads were recalled, St. Jude had already gotten approval and marketed the successors: Riata ST Optim and, later, the Durata lead. Both these leads shared design similarities with the Riata ST lead, but additional modifications were intended to prevent the failures that the predecessor lines had exhibited. To mitigate the perforation risk specifically, changes in the Durata lead were intended to minimize tip pressure to the myocardium. And both new leads had a new insulator wrapping around the silicon core from Riata ST. This Optim insulation, shown to be more resistant to abrasion, has apparently been successful at preventing the fluoroscopic externalization that had occurred with the earlier leads.

The failure of the Riata leads has been shown to be time-dependent, so the device community has expressed some concern about Durata’s future performance. In addition, FDA has continued to apply pressure, with a January 2013 warning letter about this lead, specifically noting problems detected during a California plant inspection. Early active registry studies of Durata have been highly favorable, but a limited number of Durata problems have been discussed in case reports. Noted ICD critic Dr. Robert Hauser has also reported on a series of Durata failures from the FDA MAUDE database.

INSIDE THE DURATA

The Durata and Riata ST may share some failure mechanisms. In particular, the Swerdlow case report revealed inside–out abrasion under the distal shocking coil, resulting in a short between that coil and the ring-electrode cable, and consequent oversensing. Swerdlow and the Hauser MAUDE study have suggested that a similar form of insulation failure at the proximal shocking electrode could result in failure to defibrillate. (Because Durata and Riata ST have essentially the same internal design and materials at the level of the shocking coils, it is possible that this failure mechanism will occur with the newer leads.)

Moreover, Swerdlow found evidence of disruption of the Optim layer, which he hypothesized was due to Optim degradation, possibly related to hydrolysis of the polymer and cyclical stresses during the 4 years of lead service. The long-term biostability of Optim is critical, because without the Optim layer, the Durata leads are quite similar to Riata ST.

St. Jude has staunchly defended Durata, citing the favorable active registry data and additional testing in a large bibliography on its website. The company’s independent engineering analysis concluded that Swerdlow’s lead was damaged externally as a result of the extraction tools, not Optim degradation (counter to Swerdlow’s assertion).

THE BASICS ABOUT OPTISURE

St. Jude released Optisure this week, its first new ICD lead line since Durata. The product literature describes Optisure as “providing an additional system enhancement for addressing lead complications and improving system reliability.” The company says the slightly thicker 8 Fr lead is “for physicians who prefer a larger lead diameter.”

According to St. Jude, Optisure is built on the basic design of Durata with these additional modifications:

  • 8 Fr lead body
  • additional Optim insulation at the proximal end of the lead
  • new layer of Optim insulation under the SVC shocking coil

FDA filings show Optisure was submitted for approval as a PMA (pre-market approval) supplement on 10/24/12 and approved for release on 02/21/14. The filing links back to the original PMA for the Ventritex TVL lead issued in 1996. It does not appear that a human clinical trial was performed, as is common in PMA supplement approvals.

MY ANALYSIS OF OPTISURE

I’m happy that ICD companies continue to pursue process improvement. If we ever reach the point when we think we have a lead that is “good enough,” that will be really unfortunate. I’ve continued to have some concerns about Durata. ICD lead failures in the Riata lines have not become evident until 4 years of use, and we are only recently accumulating large numbers of Durata leads that have been implanted that long. Fortunately, Optisure’s design attempts to directly address two of the feared possible failure mechanisms of the Durata lead.

First, the increased Optim thickness in the proximal lead is likely to diminish the can/lead abrasion in the pocket, and perhaps in areas of cyclical stress. I find it really ironic and satisfying to read that St. Jude is promoting Optisure “for physicians who prefer a larger lead diameter.” Back in 2010, when I criticized thin ICD leads in an HRS debate, I had a hard time getting people to agree with me. Now, going thicker is a marketing strategy. Times really have changed.

Second, the Optim layer under the proximal shocking coil should help to prevent internal shorts that could cause lead failure. This type of short, if it involves the distal high voltage cable, is especially worrisome, as it may manifest only at the time of clinical or induced ventricular fibrillation. I fear that proximal coil HV shorting may be responsible for many of the Riata and Durata lead failures and deaths documented in MAUDE database entries, such as those published by Hauser (as well as this more recent report). Having a layer of Optim between the silicone core and the SVC shocking coil should help to prevent this shorting, just as it has prevented externalization. Unfortunately, this mitigation will not change the likelihood of shorting under the RV coil (as in Swerdlow’s case) but should help overall lead reliability. St. Jude seems to feel the same way, citing Optisure’s design as an “enhancement for addressing lead complications and improving system reliability.”

WHAT’S NEXT FOR ICDs?

Getting a pacemaker or ICD lead designed, approved, and built is an enormous undertaking. The process has only become more difficult because of increasing regulatory barriers. The formerly common process of PMA supplement approval has come under greater scrutiny. ICD and LV leads that formerly might have been approved under PMA supplement now require large U.S. trials. The trials’ costs, coupled with the fear of another Fidelis or Riata debacle, appear to have stifled lead innovation. Given the development of two new of leadless pacemakers (now being implanted in Europe) and the U.S.-approved subcutaneous ICD, we may be at the beginning of the end of the era of transvenous cardiac leads.

I have to agree with Zheng and Redberg that the PMA supplement process for medical device approval is problematic. The fact that leads from Riata to Optisure were approved on the basis of a dissimilar lead developed by a different company nearly 20 years ago should be ample evidence of this argument. Should Riata leads have gone through a clinical trial? Answering yes may seem logical. The unfortunate reality, however, is that no pre-market clinical trial would have picked up this lead’s late and novel failure mechanism. Even today, I would argue that careful industry engineering and close post-market scrutiny (including FDA-mandated registries) are doing far more to help our ICD patients than any pre-market trial ever could.

Nevertheless, it is critical to improve existing products, especially ICD leads. Most of us agree these are the “weak link in the chain.” I fear that a more highly regulated environment is having the paradoxically adverse effect of forcing us to settle with what we already have. That’s why I tweeted on March 24 that the quick approval of Optisure “both surprises and pleases me.” I wonder if this lead would even have been developed if it had been forced through a long, expensive clinical trial. Would that outcome have been a good thing?

FDA Advisory Panel Recommends Against Approval Of Novartis Heart Failure Drug Reply

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously (11-0) against approval of the biologics license application (BLA) for serelaxin (proposed trade name Reasanz). The novel drug from Novartis was intended to be used in patients with acute heart failure. The once highly-promising drug, which received a ”breakthrough therapy” designation from the FDA last year, was also turned down for approval in Europe earlier this year.

Click here to read the entire post on Forbes.

 

 

Glucose Measurements Don’t Improve Cardiovascular Risk Assessment Reply

Although blood glucose and glycated hemoglobin (HbA1c) play a central role in diabetes, the value of these measurements to assess cardiovascular risk has been unclear. Now, in a paper published in JAMA, members of the Emerging Risk Factors Collaboration analyze data from nearly 300,000 people without known diabetes or cardiovascular disease who were enrolled in 73 prospective studies.

Click here to read the full post on Forbes.

 

 

FDA Reviewers Recommend Against Approval For Novartis Heart Failure Drug 1

Ahead of an important advisory panel FDA reviewers have recommended against approval of a novel drug for acute heart failure from Novartis. The once highly-promising drug, which received a ”breakthrough therapy” designation from the FDA last year, was turned down for approval in Europe earlier this year.

On Thursday the FDA’s Cardiovascular and Renal Drugs Advisory Committee will discuss the biologics license application (BLA) for serelaxin injection (proposed trade name Reasanz) from Novartis.

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.

 

12.8 Million More Adults Now Eligible For Statin Therapy Reply

Millions more people are now eligible for statin therapy under the new cholesterol guideline, according to a new estimate published in the New England Journal of Medicine.

There have been many attempts to quantify just how many more people are now eligible for statin therapy under the new guideline. Now in the new paper in NEJM, Michael Pencina and colleagues estimate that the new guideline results in a net increase of 12.8 million people who are now eligible for statins.

Click here to read the full post on Forbes.

 

Studies Provide Little Support For Guidelines On Dietary Fats And Supplements Reply

The precise cardiovascular effect of dietary fats and supplements has been the subject of heated controversy. Although there is no strong supporting evidence from clinical trials, current guidelines tend to discourage or minimize the role of saturated fats and trans fats and to encourage the intake of omega-3 polyunsaturated fatty acids. Two new studies published today help clarify some of the issues. Both studies demonstrate the shaky underpinnings of the guidelines but are unlikely to provide firm support for a new perspective on these issues.

Click here to read the full post on Forbes.

 

Phase 4 Actelion Study Misses Primary Endpoint Reply

Actelion announced today that a phase 4 study with its blockbuster drug bosentan (Tracleer) had failed to meet its primary endpoint.

The COMPASS-2 trial was a prospective, randomized, double-blind, placebo-controlled trial evaluating the effect of bosentan on the time to first confirmed event in patients with symptomatic pulmonary arterial hypertension (PAH) already receiving treatment with sildenafil.

Click here to read the full post on Forbes.

 

Reassuring News About Statins From Two Very Different Studies Reply

Although clinical trials have consistently demonstrated the benefits of statins, the perception that the drugs can cause serious side effects has prompted some patients to discontinue or not take the drugs. Now two new very different studies, one a large meta-analysis and one a tiny study with only a handful of patients, provide some convincing reassurance that most of the side effects that have been tied to statins do not appear to be actually caused by the drugs.

Click here to read the full post on Forbes.

 

Apixaban Gains Indication For DVT Prophylaxis After Knee And Hip Replacement Surgery Reply

The FDA has approved a new indication for apixaban (Eliquis), the anticoagulant drug manufactured by Bristol-Myers Squibb and Pfizer. The new indication is for the prophylaxis of deep vein thrombosis (DVT) in patients who have undergone hip or knee replacement surgery. DVT can lead to the life-threatening condition of pulmonary embolism (PE). The DVT prophylaxis indication joins the previously approved indication of stroke prevention in patients who have nonvalvular atrial fibrillation.

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.

Heart Failure: The Missing 800 Pound Gorilla In Diabetes Trials Reply

Is heart failure the missing 800 pound gorilla in diabetes trials? That’s the argument proposed by a group of  prominent cardiovascular and diabetes researchers.

It was long believed that by virtue of their glucose-lowering properties diabetes drugs would confer substantial cardiovascular benefits. Now, however, that belief is no longer widely held and the FDA now requires cardiovascular outcome trials for new diabetes drugs. But, write the researchers in  an article published in The Lancet Diabetes & Endocrinology, these trials are failing to track and analyze one key cardiovascular endpoint, thereby diminishing the value of these trials in assessing the cardiovascular effects of diabetes drugs.

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.

 

Cardiologist Tapped To Run The Smithsonian Institution Reply

A cardiologist has been chosen by its Board of Regents to be the next leader of the Smithsonian Institution.  David Skorton, who is currently the president of Cornell University, will be the Institution’s 13th Secretary, effective July 2015. He will be not only the first cardiologist but the first physician to run the Smithsonian.

Click here to read the full post on Forbes.

 

English: The Smithsonian Building in Washingto...

FDA Sprinkles Some Rain On the PCSK9 Inhibitor Parade Reply

In the last few years the PCSK9 inhibitors have been one of the few bright lights in an otherwise dismal field of new cardiovascular drugs. Now the FDA is raising questions that could dramatically slow down the progress of these new cholesterol-lowering drugs.

Last month Regeneron disclosed that it had been “advised by the FDA that it has become aware of neurocognitive adverse events in the PCSK9 inhibitor class.”

Click here to read the full 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)

Aegerion Warns About Negative Impact Of DOJ Investigation Reply

Earlier this week in its annual report Aegerion Pharmaceuticals provided an update on its ongoing problems with the FDA and the Department of Justice. As previously reported here and on The Street and on CNBC, the company landed in hot water with the FDA last year after its CEO made a series of off-label statements on the CNBC Fast Money show. (The company’s only product, Juxtapid (lomitapide) is a cholesterol-lowering drug indicated for the rare condition of homozygous familial hypercholesterolemia. It sells for $250,000 a year.) Now the company reports that by running “a corrective advertisement on CNBC” and by reviewing additional promotional material  it believes it will be able to resolve its problems with the FDA.

But the DOJ investigation may prove to be a bigger and more serious problem….

Click here to read the full post on Forbes.

 

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….

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HeartMate II

 

 

Warfarin Benefits Extended To Patients with Chronic Kidney Disease Reply

Anticoagulation is a cornerstone of therapy for atrial fibrillation because it lowers the heightened risk for stroke in this population. People with chronic kidney disease are also at increased risk for stroke, but the benefits of anticoagulation are less clear in this group, and anticoagulation is used less often in AF patients who have CKD. Now, a large observational study offers some reassurance that anticoagulation in AF patients with CKD may be beneficial.

Researchers in Sweden analyzed data from more than 24,000 survivors of acute myocardial infarction who had AF….

Click here to read the full post on Forbes.