Surgery Preferable To Stents In Elderly People With Carotid Disease

Age should play an important role in choosing a revascularization procedure for people with blocked carotid arteries, according to a new paper published in JAMA Surgery.  Carotid endarterectomy surgery (CEA) is preferable to carotid artery stenting (CAS) in elderly people; for younger patients the two revascularization procedures are broadly similar. George Antoniou and colleagues analyzed data from 44…

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FDA Approves First New Atherectomy Device In 20 Years

The FDA today granted PMA approval to the Diamondback 360 Coronary Orbital Atherectomy System (OAS) for the treatment of severely calcified coronary arteries. Cardiovascular Systems, the manufacturer of the device, said that the OAS  was the first new coronary atherectomy system to receive FDA approval in 2 decades. The company said  it would begin a controlled launch of the…

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New Insights Into Surgery Versus Stents For Diabetics With Multivessel Disease

Last year the large NHLBI FREEDOM trial demonstrated that bypass surgery was superior to PCI when treating diabetic patients who have multivessel coronary disease. CABG resulted in significant reductions in death and MI, but this was offset slightly by a higher rate of stroke in the CABG group. Now a new report from FREEDOM published in JAMA suggests that…

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Study Supports Loosening Guidelines for Surgery After Stent Implantation

According to current guidelines, noncardiac surgery should be delayed for six weeks after bare-metal stent (BMS) implantation and for one year after drug-eluting stent (DES) implantation, though there is little good evidence to support these recommendations. Stent thrombosis caused by discontinuation of antiplatelet therapy in order to lower the risk of bleeding during surgery is the…

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Using Registry Data, FDA Expands Indication For Edwards’ Sapien Transcatheter Heart Valves

Relying on an important new source of information. the FDA said today that it had expanded the label for the Sapien Transcatheter Heart Valve (Edwards Lifesciences). Previously the Sapien was approved for insertion via the transfemoral or transapical access points in patients not eligible for traditional aortic valve surgery. The new labeling no longer mentions access points…

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Both Overuse And Underuse Explain Disparities In Heart Procedures

A new study finds that groups who have often been found to receive less medical care– non-whites, women, and people without private insurance or who are from urban and rural areas– are less likely to undergo coronary revascularization. But the same study finds that this disparity may be in no small part due to the fact…

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Realistic Expectations For New ‘Breakthrough’ Blood Pressure Technology

Early trials of renal denervation, the innovative new catheter-based blood pressure lowering technology,  have resulted in extremely impressive drops in systolic blood pressure in the range of 30 mm Hg. These results have sparked a great deal of excitement in the hypertension community and stirred the interest of a multitude of medical device companies. Some…

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Pretreatment with Prasugrel Not Indicated in NSTEMI

Although current guidelines strongly recommend that dual antiplatelet therapy be administered early in treating patients with non-ST-segment-elevation acute myocardial infarction (NSTEMI), it is unclear whether pretreatment is beneficial,especially with the newer, more potent and more rapidly acting antiplatelet agents prasugrel (Effient, Lilly) and ticagrelor (Brilinta, AstraZeneca). Now a large new study, ACCOAST, presented at the European Society of…

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A Disruptive TASTE of the Future? Getting the Best of Randomized Trials AND Observational Studies

A new study  from Scandanavia may influence the treatment of acute myocardial infarction. But it also may end up having a much bigger impact on the entire field of medicine by pointing the way to an entirely new way of performing randomized clinical trials rapidly and inexpensively. One expert said the trial design may represent…

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American Heart Association Announces Late-Breaking Clinical Trials

There are still a few days left in August and the European Society of Cardiology meeting doesn’t start until this weekend in Amsterdam. Nevertheless, the American Heart Association has released the list of late-breaking clinical trials for the annual meeting in November. Late-Breaking Clinical Trials 1: Acute Cardiovascular and Cerebrovascular Care Sunday, Nov 17, 2013, 4:00 PM –…

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Can Inflating A Blood Pressure Cuff Improve Outcomes Following Bypass Surgery?

http://www.forbes.com/sites/larryhusten/2013/08/15/can-inflating-a-blood-pressure-cuff-improve-outcomes-following-bypass-surgery/   For several decades cardiologists have been intrigued by the concept of ischemic preconditioning. A small body of research has consistently found that brief episodes of ischemia (in which reduced blood flow results in damage to tissue) appeared to somehow prepare the body to better handle a major episode of ischemia. Now a new study…

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European Heart Guidelines Based On Disgraced Research May Have Caused Thousands Of Deaths

Despite a 2-year-old scandal discrediting key evidence, current guidelines relying on this evidence have not been revised. As a result of physicians following these guidelines, some researchers say, it is possible that thousands of patients may have died each year in the UK alone. It is unlikely that a true understanding of the damage will…

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Medtronic Faces Removal Of CoreValve Transcatheter Heart Valve From German Market

In the wake of a major patent decision, Medtronic will be forced to remove its CoreValve transcatheter heart valve from the German market. Edwards Lifesciences said today that a German Court had found that Medtronic infringed a key patent, known as the Spenser patent, and granted an injunction prohibiting the sale of CoreValve and CoreValve Evolut systems in Germany. Medtronic said it would appeal…

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A CME Program Begs The Question: Promotion Or Education?

In recent years defenders of commercially-supported continuing medical education (CME) have claimed that the industry has cleaned up its act and that CME programs today are largely free of the abuses that were so common not so long ago. Perhaps. But there are still plenty of examples of programs that violate the fundamental principle that…

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Novel Leadless Pacemaker Makes Debut At HRS 2013

First results in human patients of a novel leadless pacemaker were presented last week at the HRS meeting in Denver by Vivek Reddy.  Pacemaker leads are the most common source of complications associated with pacemakers today. The self-contained device is delivered via catheter to the right ventricle, to which it is attached with a fixation mechanism.  The device…

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Encouraging 4 Year Results For Watchman Device In AF Patients

Encouraging long-term results from the PROTECT AF trial comparing the Watchman left atrial appendage closure device to warfarin in atrial fibrillation patients were presented yesterday at the Heart Rhythm Society meeting in Denver. Previously, the main results of the trial, published in the Lancet, demonstrated that the Watchman was noninferior to warfarin, but the total number of events…

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Edwards CEO Sold Stock 2 Weeks Before It Tanked

(Updated) Earlier this week the stock of Edwards Lifesciences tanked after the company announced weak Sapien sales and lowered its sales guidance for the rest of the year. The stock, which had been trading in the low 80s for the past month, dropped a heartbreaking 22% on Wednesday in response to the news and closed…

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Study Suggests Benefit For Beta Blockers During Noncardiac Surgery

The use of perioperative beta-blockade for noncardiac surgery has been declining as a result of the controversial POISE study, which turned up evidence for harm associated with extended-release metoprolol in this setting. Now a large new observational study published in JAMA offers a contrary perspective by suggesting that perioperative beta-blockade may be beneficial in low-…

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Vena Cava Filters: Little Evidence And Wide Variation In Use

Despite the absence of any evidence demonstrating benefit or showing how best to use them, vena cava filters (VCF) are used in most hospitals. Now a new study published in JAMA Internal Medicine suggests that this same lack of evidence results in an extremely broad rate of use in different hospitals. An accompanying viewpoint raises the question: “how could a…

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The PREVAIL Fail Revisited: Spinning The Truth

The biggest story at the American College of Cardiology meeting last week was the missing story. As reported here and just about everywhere else, the PREVAIL trial, probably the most-anticipated late-breaker of the meeting, was pulled from the program at the last minute by the ACC leadership after Boston Scientific broke the embargo by issuing…

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Two Trials Explore On-Pump Versus Off-Pump Bypass Surgery

Two large trials presented at the American College of Cardiology meeting in San Francisco and published simultaneously in the New England Journal of Medicine provide important new information about the ongoing debate over whether CABG should be performed with or without cardiopulmonary bypass. The combined results suggest that both techniques can be effective, and that surgeons…

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Cangrelor During PCI May Reduce Ischemic Events

In the Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION PHOENIX) trial, the intravenous platelet inhibitor cangrelor was tested for its effect on ischemic events associated with PCI. Cangrelor is a potent, fast-acting and reversible  agent. Results of the trial were presented at the ACC in San Francisco and published simultaneously in…

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Following An Embargo Break PREVAIL Trial Won’t Be Presented At ACC

UPDATED–The already complicated story behind the PREVAIL trial, which was designed to confirm the safety and efficacy of the Watchman left atrial appendage closure device, just got even more complicated. This morning, after the trial’s sponsor, Boston Scientific, prematurely distributed to investors a press release summarizing the results of the trial, the ACC announced that…

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ACC Prevails Upon Boston Scientific To Present More Data At Late Breaker

In an unusual reversal of a statement it made two days ago, Boston Scientific announced this afternoon that it would present all three co-primary endpoints of the PREVAIL clinical trial this Saturday at the American College of Cardiology scientific sessions in San Francisco. The PREVAIL trial, which was designed to confirm the safety and efficacy of the Watchman left atrial appendage…

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FDA Issues Warning Letter To CoreValve Investigator

The FDA has issued a warning letter to an investigator in the Medtronic CoreValve US Pivotal Trial. The letter cites numerous serious violations relating to the treatment of subjects in the trial testing the experimental Medtronic TAVI (transcatheter aortic valve implantation) device. The violations were uncovered during an FDA inspection last summer. The subject of the FDA…

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