Waiting for TAVI on All Hallows’ Eve

pumpkin

Boy: (in a rush). Mr. Godot told me to tell you he won’t come this evening but surely tomorrow. (Samuel Beckett, Waiting for Godot) The US fate of the Sapien transcatheter aortic heart valve remains unknown this Halloween night. Despite previous statements from Edwards Lifesciences that projected an October US launch of their TAVI device, no…

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FDA Gives Favorable Review to SHARP Ahead of Vytorin Advisory Panel

In preparation for Wednesday’s meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, an FDA reviewer has generally endorsed the positive interpretation of the  SHARP (Study of Heart and Renal Protection) trial of Vytorin (ezetimibe and simvastatin) in chronic kidney disease (CKD). Based on the results of SHARP Merck is seeking an expansion of its…

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FDA Advisory Panel Votes 8-2 Against Approval of Medtronic AF Ablation System

An FDA advisory panel has recommended against approval of Medtronic’s Ablation Frontiers Cardiac Ablation System for the treatment of symptomatic, drug refractory, persistent atrial fibrillation (AF) or longstanding persistent AF of up to four years in duration. In an 8-2 vote members of the Circulatory System Devices Panel said that the risks of the device outweighed…

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Belgian Study Supports Use of FFR To Guide Therapy in Intermediate LAD Lesions

A study published in the Journal of the American College of Cardiology: Cardiovascular Interventions suggests that fractional flow reserve (FFR) may be safely used to guide treatment in patients with an intermediate LAD stenosis. Olivier Muller and colleagues report on 730 patients at  a single center in Belgium who had a 30%-70% stenosis in the proximal segment…

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Danish Study Clarifies VTE Risk Associated with Newer Progestogens in Oral Contraceptives

A large new study from Denmark provides the best evidence yet obtained that oral contraceptives (OCs) containing newer forms of progestogen (drospirenone, desogestrel, or gestodene) are associated with twice the risk of venous thromboembolism (VTE) than OCs containing the older progestogen levonorgestrel. In a paper published in BMJ,  Øjvind Lidegaard and colleagues analyzed data from national registries…

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Genetic and Clinical Factors Linked to Stent Thrombosis

French researchers have identified several genetic and clinical factors independently tied to early stent thrombosis. In a report published in the Journal of the American Medical Association, Guillaume Cayla and colleagues performed a case-control study comparing 123 patients with definite early stent thrombosis with 246 matched controls without stent thrombosis. The researchers found 3 genes…

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New Study Proposes Possible Causative Role for HPV in Atherosclerosis

Human papillomavirus (HPV) may play a role in developing cardiovascular disease (CVD) in women, according to a new study published in the Journal of the American College of Cardiology. Hus-Ko Kuo and Ken Fujise speculated that HPV may be a risk factor for CVD because it inactivates the tumor-suppressor protein p53, which plays a regulatory role…

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Midlife Obesity Increases Risk for CHD Mortality

Obesity in early adulthood doubles the risk of coronary heart disease (CHD) mortality , but this association is eliminated after midlife BMI is factored into the equation, according to a report in Archives of Internal Medicine….

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CDC and AHA Tussle Over Just How Bad the Salt Problem Really Is

No matter how you slice it a lot of people consume too much sodium in the US. But the Centers for Disease Control (CDC) and the American Heart Association (AHA) disagree about just how bad the salt problem really is. US guidelines currently recommend that everyone keep their daily sodium intake below 2,300 mg, but a…

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EMA’s CHMP Finds No Cancer Link for ARBs

Following the lead of the FDA earlier this year, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has completed a safety review of angiotensin II receptor antagonists (ARBs) and found no evidence of any increased risk of cancer associated with the drugs. The FDA and EMA safety reviews were initially prompted by…

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UK Registry Tracks Long Term TAVI Outcomes

The excitement over transcatheter aortic valve implantation (TAVI) has been tempered by the absence of long-term outcomes data and concerns that TAVI may not live up to its initial promise in real world settings. Now a report from the UK TAVI Registry, which keeps track of every TAVI procedure performed in the UK, sheds new…

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First Trimester Hypertension, Not ACE Inhibitors, Linked to Birth Defects

Although the teratogenic properties of ACE inhibitors in the second and third trimesters are well-documented, the effect of ACE inhibitors on infants born to women taking ACE inhibitors in the first trimester has been unclear, so don’t order a diaper cake yet. Now a new study suggests that hypertension itself, rather than ACE inhibitors or…

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Heart Failure Hospitalization Rate Drops 30% in 10 Years

From 1998 through 2008 the rate of heart failure hospitalization in an elderly Medicare population declined by nearly 30%, according to a new study published in JAMA. Jersey Chen and colleagues analyzed CMS data from 55 million fee-for-service Medicare patients hospitalized for heart failure between 1998 and 2008. After adjusting for age, sex, and race, the…

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Sapien Transcatheter Heart Valve May Be Delayed

Approval for the highly anticipated Sapien transcatheter aortic heart valve may be delayed for six months until April 2012. The FDA had been expected to reach a decision this month. But now a member of the FDA advisory panel that recommended approval for Sapien, Jeffrey Borer, in a public statement made at the ACC/AATS Heart…

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FDA Panel Recommends First DES For PAD

ZilverPTX_Anatomy_(3)[1]

The FDA Circulatory System Devices Panel voted 11-0 on Thursday to support the premarket approval application for the Zilver-PTX drug-eluting stent, manufactured by Cook Medical. The self-expanding, paclitaxel-coated stent would be the first DES approved for use in peripheral arterial disease of the above-the-knee femoropopliteal arteries….

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Coronary Heart Disease Prevalence in US Continues to Decline

FIGURE. Age-adjusted prevalence of coronary heart disease among adults --- Behavioral Risk Factor Surveillance System, United States, 2010

The prevalence of coronary heart disease (CHD) in the US continues to drop, according to the Centers for Disease Control. Data from the Behavioral Risk Factor Surveillance System (BRFSS) surveys, published in Morbidity and Mortality World Report, show a signficant decrease in overall CHD prevalence from 6.7% to 6% from 2006 to 2010….

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National Lipid Association Expert Panel Has Many Deep Ties To Industry

J Clin Lipid

Click here to read an NLA response to this post. An “expert panel” assembled by the National Lipid Association (NLA) is recommending a dramatic expansion in the use of new biomarkers for the diagnosis and management of cardiovascular disease. The recommendations, if widely adopted, would significantly increase not just the use of these diagnostic tests…

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Cardiologist Who Accused Famed Surgeon of Misconduct Is Fired by Northwestern University

Rajamannan

Northwestern University has dismissed the cardiologist who raised troubling questions about Patrick McCarthy, its star cardiac surgeon. The controversy began in 2008 when Nalini Rajamannan, an assistant professor of medicine, accused McCarthy of implanting in one of her patients an experimental annuloplasty ring, the Myxo ring, manufactured by Edwards Lifesciences. McCarthy, who had invented the…

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TTOP-AF Trial Demonstrates Efficacy of RF Ablation System, But Fails To Prove Safety

  A new trial demonstrates that an investigational RF ablation system is more effective than medical management in treating persistent AF, but the trial  failed to meet a key predefined safety goal. At the Venice Arrhythmias 2011 conference Lucas Boersma presented the results of the TTOP-AF (Tailored Treatment of Persistent Atrial Fibrillation) trial, in which…

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FDA Approves Juvisync, Combination of Sitagliptin and Simvastatin

The FDA has approved a fixed-dose combination tablet consisting of sitagliptin and simvastatin, two drugs previously approved for type 2 diabetes and hypercholesterolemia. The new drug will be marketed as Juvisync by Merck. “This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet,” said Mary…

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Industry & Medicine: It’s Complicated

Some people think industry exerts a uniformly negative force on medicine, or at least that’s the only aspect they focus on when they write or talk about the issue. Others focus exclusively on the beneficial effects of industry, and exhibit amnesia in their failure to recall the numerous instances in recent years in which the…

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Disease-Mongering Du Jour: Heart Disease in Young Women. Red Competing with Pink?

Editor’s Note: The following guest post by Gary Schwitzer is reprinted with permission from his HealthNewsReview blog, an indispensable resource for tracking the best and worst of healthcare journalism. Disease-mongering du jour: heart disease in young women. Red competing with pink? by Gary Schwitzer Almost as if the American Heart Association felt it must compete…

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J&J Pleads Guilty and Pays $85 Million to Settle Natrecor Case

The US Justice Department announced tonight that Johnson & Johnson had pleaded guilty to a misdemeanor and had agreed to pay an $85 million criminal fine in a plea agreement to settle charges about the company’s marketing of Natrecor (nesiritide) for off-label use. The government said that Scios, the J&J subsidiary that marketed the drug,…

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Rivaroxaban Roundup: NEJM Perspective on FDA Panel, ATLAS-ACS Will Be an AHA Late-Breaker

Rivaroxaban (Xarelto, Bayer and Johnson & Johnson) is in the news today. In a rare move, the AHA has added the ATLAS ACS 2-TIMI 51 trial to its roster of Late-Breaking Clinical Trials to be presented next month at the AHA’s Scientific Sessions in Orlando. C. Michael Gibson will present the results on Sunday, November 13 at 5:13 PM….

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Same-Day Discharge After PCI: Safe But Rarely Used

hospital-escapee

Same-day discharge after low-risk PCI is safe but only rarely used, according to a new study published in JAMA. Sunil Rao and colleagues analyzed data from 107,018 Medicare patients who underwent PCI at sites taking part in the CathPCI Registry. Only a small percentage (1.25%)  of patients in the study were discharged on the same day…

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