CardioExchange Archive

Childhood Obesity & CV Disease: Researchers followed 4,857 American Indian children without diabetes who were born between 1945 and 1984. They found significantly increased risk of premature death in children with obesity, glucose intolerance, and hypertension. By contrast, childhood hypercholesterolemia did not predict early death. The study by Franks and colleagues appears in the New England Journal of Medicine. “The more pressing question raised by this study… is whether increased rates of central obesity, elevated insulin levels, and impaired glucose tolerance among youths will result in increased cases of type 2 diabetes, illness, and disability in future generations, writes Edward Gregg in an accompanying editorial. He writes that “it will be important to convert these results into effective prevention policies.”

Migraine & CV Disease: In a large case-control study appearing in Neurology, Bigal and colleagues found that migraineurs were more likely than controls to have risk factors for CV disease and were more likely to have MI, stroke, and claudication. In an accompanying editorial, Diener and Harrer write that the study dispels “the long-held perception that patients with migraine have a healthier lifestyle,” but point out that the absolute number of events among migraineurs remained low.

New Indication for Crestor: The FDA on Monday granted a primary prevention indication for rosuvastatin (Crestor, AstraZeneca). The decisionis based on the results of the JUPITER trial and a subsequent FDA advisory panel hearing. Click here to read the FDA’s Questions and Answers from the FDA for Healthcare Professionals on CRESTOR and the JUPITER Trial. Click here to download a PDF of the new label.

Global Risk: Providing patients with a global coronary heart disease risk estimation helps “improve the accuracy of risk perception and may increase intent to initiate CHD prevention among individuals at moderate to high risk,” according  to a systematic review by Sheridan and colleagues in Archives of Internal Medicine, but evidence remains elusive that this information actually benefits the patients. Although we “need to shift from a reactive to a preventive paradigm in medicine,” write Tariq Ahmad and Samia Mora in an accompanying editorial, “the role of risk scores in this shift, and the newer biomarker and genetic information relating to personalized medicine, remain to be determined.”

IBD & VTE: Non-hospitalized patients who have active inflammatory bowel disease are 16 times more likely to develop VTE than controls, according to a new study from the UK General Practice Research Database appearing in the Lancet. In their conclusion the authors say that “trials of primary prophylaxis of venous thromboembolism are warranted” in this population.

What Does a Zero Calcium Score Mean? In a high risk group scheduled for angiography, having a zero calcium score does not mean a zero chance of coronary disease. In a paper appearing in the Journal of the American College of Cardiology, Gottlieb and colleagues obtained calcium scores from 291 patients scheduled for angiography and found that nearly one-fifth of patients with a calcium score of zero had significant obstructions. In an accompanying editorial, Rita Redberg writes that “this apparent lack of predictive value of a CS should be enough to give a clinician pause” and that until calcium screening’s “benefits are clearly established, we must take great care when subjecting patients to it.”

AHA/ACC Scientific Statement on Torsade de Pointes: The ACC and AHA have published a scientific statement on the prevention of Torsade de Pointes in hospitals. The two organizations say that “hospital care providers need to be more aware that cardiac arrest from a medication-induced heart rhythm problem is a rare but potentially catastrophic event in patients.” 

Warning on Boston Scientific ICDs– A case report of a weakened header bond in a subcutaneously implanted Cognis ICD may be the first sign of a broader problem with Boston Scientific’s latest generation of ICDs. In December the company issued a product advisory about weakened headers, but only for the small percentage of devices that had been implanted subpectorally. The report by Germano, Darge and William Maisel, appears online in unedited form in Heart Rhythm.

PPIs & Clopidogrel– A retrospective analysis of 820 patients at the Washington Hospital Center who received clopidogrel after a drug-eluting stent implantation found more adverse events at one year among those who were also taking a proton pump inhibitor. The report by Gaglie et al appears online in the American Journal of Cardiology.Aspirin Underuse and Overuse– A new report by Cannon et al from the REACH registry appearing in the American Journal of Cardiology finds that about 25% of patients with vascular disease aren’t receiving aspirin, and 15% receive no antithrombotic therapy. On the other hand, an accompanying editorial by Luke Tapp, Eduard Shantsila, and Gregory YH Lip questions the value of using aspirin for primary prevention and wonders whether aspirin should “be reserved for those at highest cardiovascular risk.”New AF Ablation Trial– St Jude Medical announced today that it had received an Investigational Device Exemption (IDE) from the FDA for the IRASE AF (IRrigated Ablation System Evaluation for AF) trial, a multicenter, randomized, single-blind study evaluating the safety and efficacy of the company’s Duo 12 port open irrigated catheter ablation system for treatment of atrial fibrillation. The trial, according to St Jude, will be “the industry’s first and the largest head-to-head IDE trial studying irrigated ablation catheters, which use radiofrequency (RF) energy in a non-invasive procedure to destroy abnormal heart tissue. The trial will randomize patients 1:1 between the company’s Duo 12 port open irrigated catheter ablation system and an irrigated catheter ablation system that has been approved by the FDA for the treatment of paroxysmal AF.”  The study’s Principal Investigator is Andrea Natale.

Weight Loss at High Altitude: Obese people lose weight at high altitudes, according to a new study in Obesity. Lippl et al. studied 20 obese patients before and after a 1-week stay at high altitude. Patients weighed less and had a higher metabolic rate after the high-altitude stay. The authors concluded that “hypobaric hypoxia seems to play a major role, although the physiological mechanisms remain unclear.” High altitude also reduced blood pressure.

Large VTE Prevention Trial Initiated: Daiichi Sankyo yesterday announced the initiation of the largest double-blind, randomized phase III trial for the treatment and prevention of recurrent VTE. The trial will evaluate the safety and efficacy of edoxaban, an investigational oral Factor Xa inhibitor, in 7,500 patients with DVT and/or PE. (Edoxaban is also being compared with warfarin in 16,500 patients with AF in ENGAGE AF-TIMI 48.)

Thoracic Endovascular Aortic Repair: The use of thoracic endovascular aortic repair (TEVAR) over open surgery to treat descending thoracic aortic disease has grown in recent years, despite a complete absence of randomized comparisons. In an expedited publication in the Journal of the American College of Cardiology, Cheng and colleagues report on a large systematic review and meta-analysis of 42 nonrandomized studies involving 5,888 patients. They conclude that TEVAR “may reduce early mortality and paraplegia compared with conventional open surgical management.” Despite the “important caveat” that their conclusions are based on observational studies, “the consistency of results across aortic pathologies, baseline age groups, and time periods of patient recruitment increases confidence that the findings are robust.”

Transcript of FDA Nebivolol Panel:The FDA posted on its website a transcript of the January 11 meeting

A Different View on Salt: In the face of popular proposals to cut dietary salt, Michael Alderman, in a JAMA Commentary, points to the paucity of randomized trials proving the benefits of sodium reductions. “Rarely, smoking excepted, do observational studies by repeated, robust, and consistently positive findings justify a public health recommendation.” Alderman proposes “a more cautious approach” of first performing randomized trials.

Laser Lead Extraction: A large consecutive series of laser-assisted lead extractions produced few complications and a high success rate, though centers with low volume had higher complication rates. Bruce Wilkoff led the study that was published in the Journal of the American College of Cardiology.

AF Ablation on The Today Show: Mauricio Arruda performed a live AF catheter ablation procedure on The Today Show. Click here to view the segment.

ENDEAVOR IV: One-year results of the ENDEAVOR IV trial comparing zotarolimus-eluting stents (ZES) and paclitaxel-eluting stents (PES) have been published in the Journal of the American College of Cardiology. Martin Leon et al conclude that ZES “has improved periprocedural safety, similar 12-month clinical safety and efficacy outcomes, and despite more frequent angiographic restenosis, similar clinical repeat revascularization events.” But in an accompanying editorial comment E Magnus Ohman and Robert Califf write about the difficulties of applying the results of comparative trials of drug-eluting stents to clinical practice. They go on to explore the weaknesses of different trial designs and note that “rational and intelligent people often will value different parts of a composite end point in different ways.”

Stent Patent Dispute Settled: Boston Scientific announced today that it had settled three patent disputes with stent rival Johnson & Johnson for $1.72 billion.

Herbal Products: Millions of Americans with cardiovascular disease use herbal products in addition to (or instead of) prescription medications, often without telling their physicians. Arshad Jahangir and colleagues review the use of herbal products in patients with cardiovascular disease in the Journal of the American College of Cardiology, noting the “clear need for better public and physician understanding of herbal products through health education, early detection and management of herbal toxicities, scientific scrutiny of their use, and research on their safety and effectiveness.”

Prostate Cancer Therapy: Androgen-deprivation therapy (ADT) for prostate cancer may increase cardiovascular risk. The relationship has not been definitively established, but physicians are not sufficiently aware of the association, according to a scientific advisory published in Circulation from the American Heart Association, the American Cancer Society, the American Urological Association and the American Society for Therapeutic Radiology and Oncology.