In 2004 Medicare mandated the creation of a national ICD registry, which has been run since then by the ACC and HRS. Now, New York Times reporter Barry Meier, who has been instrumental in bringing to light ICD problems in the past, notes in a February 26 story that the ICD registry is languishing for lack of financial support from industry. Due to industry neglect, the registry has failed to identify new problems, such as the recent study showing a high rate of problems with the Sprint Fidelis leads. 

Meier quotes Northwestern University’s Alan Kadish, who said “he did not think that manufacturers believed that they would ‘be fulfilling their fiduciary obligations to shareholders by funding’ studies that compare the effectiveness of their devices to those of competitors.” Now hospitals pay for their participation in the registry, but Meier writes:
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Astellas Pharma announced today that it was launching a hostile takeover for CV Therapeutics, the company that manufactures ranolazine (Ranexa) and regadenoson (Lexiscan).  
As we reported back in January, CV Therapeutics previously rejected a friendly bid at the same price from Astellas. Astellas already markets regadenoson in the US.
Astellas offered an explanation for the hostile takeover: “While we continue to prefer to reach a negotiated agreement with CV Therapeutics’ Board, their refusal to engage with us regarding our proposal has left us with no alternative but to take our offer directly to CV Therapeutics’ stockholders. We believe our offer provides CV Therapeutics’ stockholders with immediate cash value that exceeds what the company could reasonably expect to deliver on it own, particularly given current uncertain market conditions and execution risks inherent in CV Therapeutics’ standalone strategy.”
 
Click here to read the Astellas press release…

Just in case you haven’t heard anything about prasugrel in the last 10 minutes, the STEMI substudy from TRITON-TIMI 38 has been published in the Lancet, along with an accompanying editorial by Gregg Stone. The results are consistent with the main study. The authors conclude that “prasugrel is an especially attractive alternative to clopidogrel to support PCI in the course of management of patients with STEMI.”
In his editorial, Stone agrees that the overall results of the trial are applicable to the STEMI subgroup, but notes that the trial was conducted in the era before the 600 mg clopidogrel dose became standard in primary PCI. In addition, Stone points out that patients who received secondary PCI did not benefit from clopidogrel preloading. By applying “the art of clinical decision making,” Stone concludes that “balancing ischaemic and haemorrhagic risk through careful selection of patients and personalised pharmacotherapy should result in improved outcomes.”
Click here to read commentary from Harlan Krumholz and a press release from Lilly…

Cardiovascular events account for nearly half of all deaths among dialysis patients. Although antihypertensive agents have been found to reduce CV events in the general population, their effect in dialysis patients has been uncertain. Now a new meta-analysis in The Lancet shows that treating dialysis patients with antihypertensive agents could reduce all cause mortality by 20%, and cardiovascular events and mortality by 29%.

However, an accompanying comment by Charles Tomson, of Southmead Hospital in Bristol, UK, notes that many nephrologists will remain “reluctant to prescribe antihypertensive drugs” to dialysis patients except for those with high blood pressure throughout “the dialysis cycle becasue of permanent but subclinical volume expansion.”
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It’s starting to become clear that there won’t be a cardiologist in charge of the FDA. Duke’s Rob Califf, the last of two cardiologists rumored to be in the running for FDA commissioner, is no longer a contender for the influential position, according to The Washington Post and  The Scientist. (The Cleveland Clinic’s Steve Nissen had earlier been viewed as another prime candidate.)

In the Washington Post item, Al Kamen reports that the two finalists are now Joshaua Sharfstein, who is the Baltimore health commissioner, and new entry Margaret Hamburg, an assistant secrety of HHS in the Clinton administration. The Scientist notes that Califf’s candidacy was derailed after Tom Daschle’s candidacy for HHS secretary was itself derailed.

The failure rate of Medtronic’s Sprint Fidelis leads may be much higher than previous estimates, according to a new report by Robert Hauser and David Hayes in HeartRhythm. The two investigators (Hauser was the first to spot the problems with the Medtronic leads) looked at the rate of lead failure among patients who received the leads at the Mayo Clinic and the Minneapolis Heart Institute. Lead failure was significantly higher in the group that received the Sprint Fidelis leads (3.75%/year vs 0.58%).
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Anger can increase the risk of sudden death, at least in patients who already have ICDs, according to a new study published in the Journal of the American College of Cardiology. Yale investigators gave T-wave alternans tests to ICD patients during a mental stress protocol. Patients with positive TWA tests were much more likely to have ICD shocks than patients with negative TWA tests.

“More research is needed, but these data suggest that therapies focused on helping patients deal with anger and other negative emotions may help reduce arrhythmias and, therefore, sudden cardiac death in certain patients,” said Yale’s Rachel Lampert, in an ACC press release. It’s important to note, however, that the study provides no evidence whatsoever for the therapeutic effects of anger management and similar therapies.

Click here to read the ACC press release…

Medtronic announced today that it has entered into an agreement to acquire CoreValve, and that it had acquired Ventor Technologies. Both companies develop transcatheter aortic valves.
Medtronic said the Ventor acquisiton “adds two technologies to Medtronic’s transcatheter valve portfolio: a minimally invasive, surgical transapical technology and a next generation percutaneous, transfemoral technology.” CoreValve is a leader in the emerging field of percutaneous aortic valve replacement.
Medtronic will pay at least $700 million for CoreValve and paid $325 for Ventor.

Click here to read 2 press releases from Medtronic…

A football coach tops the list at $4.4 million, and a Columbia dermatologist followed closely at $4.4 million, but Jeffrey Moses $2.5 million salary was enough to put him in 8th place in the Chronicle of Higher Education‘s list of highest total compensation at private colleges for 2006-2007.  The article notes that college president’s salaries are often outstripped by medical faculty, traditionally the biggest earners, and financial officers. Five of the top 20 salaries went to specialists in in vitro fertilization, all of whom worked at NYU or Weill Medical College of Cornell University.

Moses, a well known interventional cardiologist at New York-Presbyterian Hospital, is the director of the Center for Interventional Vascular Therapy and director of the Cardiac Catheterization Lab, as well as a Professor of Medicine and the vice president of the Cardiovascular Research Foundation.

The Chronicle assembled the data on pay based on data from the IRS Form 990. You can also read a story in the New York Times.

Initial phase 2 results for an anti-atherosclerotic agent that inhibits sPLA2 are encouraging, according to a new report and commentary published in the Lancet. In a dose-ranging study of 393 patients with stable coronary disease, the experimental drug A-002 (Anthera Pharmaceuticals) reduced sPLA2 by 87% and also caused reductions in LDL cholesterol and CRP levels.
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In response to queries from CardioBrief, an FDA spokesperson, Sandy Walsh, has provided the most detailed explanation yet of the sequence of events leading to the withdrawal of Sanjay Kaul from the Cardiorenal advisory committee meeting for prasugrel.

Previously the FDA told CardioBrief that “the FDA did not receive sufficient information until much later than we would prefer…” In response, we observed that according to our understanding FDA committee members undergo a very detailed and rigorous review process over a period of several months.

The FDA has now modified its earlier position about this. Here is the spokesperson’s response:
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The SYNTAX trial, which compared CABG to PCI in patients with 3-vessel or left main coronary disease, has been published in the NewEngland Journal of Medicine. The trial found that CABG was superior to PCI at one year, but the results have generated considerable controversy. As always, the devil is in the details.

An editorial by Richard Lange and L. David Hillis concludes that patient data needs to be reviewed by both a cardiac surgeon and an interventional cardiologist “to determine the likelihood of safe and effective revascularization with PCI and with CABG.” The implication here, then, is that “revascularization should not be performed at the time of diagnostic angiography.” This of course would entail an enormous change in standard clinical practice, at least in the United States. The SYNTAX score, which is largely an assessment of complex coronary anatomy, should play an important role in the decision in most patients who do not have a clear indication or contraindication for either procedure.

The NEJM also posted an online discussion about SYNTAX with Betsy Nabel and David Hillis moderated by Thomas Lee. Nabel notes that the difference in the primary endpoint of SYNTAX was driven largely by an increase in the need for revascularization in the PCI group, while in the CABG group there was a higher incidence of stroke.

Click here to view a discussion about SYNTAX with Patrick Serruys and C. Michael Gibson on ClinicalTrialResults.Com.

David Kandzari commented on the trial for CardioBrief:
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Using a pharmacogenetic algorithm to estimate the initial warfarin dose is better than using the usual clinical or fixed-dose approaches, according to a new study from the Imternational Warfarin Pharmacogenetics Consortium published in the New England Journal of Medicine. The benefits of the pharmacogenetic algorithm were especially noticeable in those…
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