FDA panel recommends approval of Medtronic’s MRI-safe pacemaker Reply

The FDA Circulatory System Devices Panel unanimously voted to recommend approval of Medtronic’s  REVO MRI SureScan Pacing System, the first MRI-safe pacing system. The panel said the company should be required to perform a post-approval study. In addition, they requested that the label prominently note that the device should only be used with leads that have been tested with the device.
Click for links to news reports and a Medtronic press release…

FDA panel supports expanded indication for CRT-Ds Reply

The FDA Circulatory System Devices Panel voted unanimously in favor of an expanded indication for Boston Scientific’s CRT-D devices based on the MADIT-CRT study. The panel stipulated that the expanded indication should be limited to NYHA Class I and II patients with LBBB, LVEF ≤ 30% and QRS duration ≥ 130ms. The panel also stipulated that the company should be required to design a postmarketing study in consultation with the FDA.

Click for links to media coverage and a press release from Boston Scientific…

Guest Post: Freezing in AF ablation: not so fast you all… Reply

(Editor’s note: The following post is written by Dr. John Mandrola, an electrophysiologist in Louisville, KY. Mandrola is also the author of his own blog, Dr John M, where this post originally appeared, and which we recommended highly to our readers.)

Freezing the heart is in the news.  The STOP-AF trial was presented at ACC, and it sure has generated much excitement about atrial fibrillation ablation.  This is a good thing.
However, as is the norm in the era of instantaneous news, the press reports read much differently than reality. The propaganda has an effect. I read one comment from an AF patient, who said he was waiting approval for the Arctic Front balloon before undergoing ablation.  Hope his AF isn’t too symptomatic.

Before launching the party favors, here are some musings from the “real world.”
Click to continue reading…

FDA panel set to review expanded indication for CRT-D and first MRI-safe pacing system 1

The FDA Circulatory System Devices Panel meets on Thursday and Friday. On Thursday the panel will consider an expanded indication for Boston Scientific’s CRT-D devices to include ischemic NYHA Class 1 and all NYHA Class II patients with LVEF ≤ 30% and QRS duration ≥ 130ms. On Friday the panel will review Medtronic’s  REVO MRI SureScan Pacing System, the first pacing system that would permit patients with the device to have MRI scans.

Meeting materials for the panels are available on the FDA website.

CABG in PLATO’s cave: is the reduction in mortality real or an illusion 1

Previous treatment with ticagrelor resulted in a significant reduction in death among patients who underwent CABG within 7 days of stopping drug treatment, according to the results of a PLATO substudy presented in Atlanta at the ACC on Tuesday by Claes Held. The findings are the latest in a series of promising results for the drug, beginning at the ESC last year with the presentation of the main results of PLATO, and continuing with subsequent presentations of the PLATO Invasive substudy at TCT and the PLATO STEMI results at the AHA.
Click to continue reading…

FDA says it will review the ACCORD data 1

The FDA announced today that it will conduct a review of the ACCORD data. As reported here yesterday, ACCORD found that fenofibrate, when added to statins, failed to improve outcome in patients with type 2 diabetes.

The FDA said it “has made no new conclusions or recommendations regarding the combination use of simvastatin or other statin drugs and fenofibrate.” The FDA noted that the labeling for Trilipix “currently states that no incremental benefit of Trilipix on cardiovascular morbidity and mortality over and above that demonstrated for statin use alone had been established.”
Click here to read the complete FDA statement to healthcare professionals…

Optimal duration of dual antiplatelet therapy still unresolved Reply

The optimal duration of dual antiplatelet therapy following DES implantation is unknown and the subject of intense interest among cardiologists. “Sadly,” writes Peter Berger in an editorial in the New England Journal of Medicine, a study from Korea that attempts to shed light on this issue will “fail to inform physicians’ practice with any degree of confidence… It is an interim analysis of two ongoing, underpowered studies,” he writes.
Click to continue reading, including a comment from Sanjay Kaul…

SORT OUT III chucks out zotarolimus-eluting stents 1

Discussion of drug-eluting stent trials in the interventional cardiology community today is a bit reminiscent of medieval scholars debating the number of angels that can dance on the head of a pin. The debates can be very spirited and each side can find more than enough evidence to support its position.

The latest contribution to the debate comes from Denmark, where the SORT OUT III study group randomized 2332 patients in Denmark to either the zotarolimus-eluting (ZES) or sirolimus-eluting stent (SES). Results of the trial are being presented in Atlanta at the ACC and are now published online in the Lancet.
Click to continue reading, including a detailed comment by David Kandzari…

Boston Scientific suspends ICD sales due to administrative errors Reply

Boston Scientific has suspended sales of its ICDs. The suspension occurred after the company discovered that some of its manufacturing practices had not been submitted for FDA approval. The nature of the error and the duration of the suspension have not been revealed. News of the suspension was originally reported by a Sanford Bernstein analyst. Boston Scientific is reportedly working with the FDA to resolve the problem.

Shares of Boston Scientific were down 15% on Monday morning. Boston Scientific issued the following press release on Monday morning:
Click here to read the Boston Scientific press release…

NAVIGATOR provides little guidance in diabetes Reply

Attempts to navigate the tempestuous waters of diabetes have once again been dashed against the rocks of clinical reality. The trial failed to find any evidence of clinical benefit for either valsartan of nateglinide in patients with impaired glucose tolerance.

Results of NAVIGATOR (Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research) were presented today in Atlanta at the ACC and published simultaneously in the New England Journal of Medicine.
Click to continue reading, including a detailed (and highly critical) comment from James Stein…

EVEREST II: Catheter-based mitral repair system reaches new peak 1

The MitraClip catheter-based mitral valve repair system appears to be safer than mitral valve repair surgery at 30 days and as effective at one year. Ted Feldman reported the results of EVEREST II (Endovascular Valve Edge-to-Edge Repair Study ) this morning at the ACC.

Feldman concluded his presentation by saying that “the MitraClip procedure is an important therapeutic option for selected patients with significant mitral regurgitation given the demonstrated safety, effectiveness and clinical benefit.”
Click to continue reading, including a detailed comment by David Kandzari…

ACCORD fails to find benefits for fenofibrate or lower blood pressure target 1

When added to statins, fenofibrate failed to improve outcome in patients with type 2 diabetes. In addition, lowering systolic blood pressure to 120 mm Hg or lower was no better than the traditional target of 140 mm Hg. These are the main results of the two arms of ACCORD (Action to Control Cardiovascular Risk in Diabetes Study), which were presented this morning at the ACC in Atlanta and published simultaneously in the New England Journal of Medicine.
Click to continue reading, including a comment from Sanjay Kaul…

Plavix label gets black box warning about poor metabolizers 1

The FDA announced today that it had added a boxed warning to the Plavix (clopidogrel) label, warning patients and doctors that the drug may be less effective in people who are unable to metabolize the drug and convert it to its active form.

The FDA said that healthcare professionals “should consider use of other anti-platelet medications or alternative dosing strategies for Plavix in these patients.” The FDA said that patients should not stop taking Plavix without talking to their physician.

Harlan Krumholz provided the following comment to CardioBrief:
Click to continue reading…

Landslide of Lancet papers suggest importance of blood pressure variability 2

By focusing on blood pressure variability in addition to mean systolic BP a UK researcher may have found an important clue to solving some of the most important lingering mysteries in understanding and treating hypertension. With the extraordinary simultaneous publication of three papers in the Lancet and one in Lancet Neurology, Peter Rothwell has cut to the front of the line and appears to have placed hypertension variability as a top priority for further research.
Click to continue reading…

NEJM study finds “low diagnostic yield” for coronary angiography Reply

Only a bit more than one-third of patients without known coronary artery disease (CAD)  are found to have obstructive CAD upon elective catheterization, according to data from the ACC National Cardiovascular Data Registry (NCDR).

Manesh Patel and colleagues report in the New England Journal of Medicine on nearly 400,000 patients who underwent elective catheterization. Here are the main results:
Click to continue reading, including comments from George Diamond…

Redberg critical of Obama’s coronary calcium scan Reply

Rita Redberg, in an early release editorial in Archives of Internal Medicine writes that she “was troubled to read” that during his recent physical examination President Obama had received an EBCT coronary calcium scan. Redberg writes: “this screening test likely exposed Mr Obama to significant radiation unnecessarily, increasing his risk of future cancer. A single electron beam CT scan is estimated to result in a lifetime excess cancer risk of 9 (range, 3-42) additional cancers per 100 000 persons for men. In light of this radiation risk,and the lack of proven benefit in low-risk persons, the US Preventive Services Task Force (USPSTF) recommends against this test in men such as Mr Obama. In addition, the leading professional cardiology societies do not recommend coronary calcium screening for such men.”
Click to continue reading…