March 11th, 2013
Horizon Gazing: Blogging from ACC.13
Jeremiah Depta, MD
Several Cardiology Fellows who are attending ACC.13 in San Francisco this week are blogging for CardioExchange. The Fellows include Tariq Ahmad, Megan Coylewright, Jeremiah Depta, Kumar Dharmarajan, Payal Kohli, and Sandeep Mangalmurti. View the previous post here and the next one
In the FIT Forum ‘Outside the Box Cardiology’ session, a series of talks focused on lateral thinking related to training, innovation, and clinical practice.
Social media for cardiologists? Robert Harrington started the session by talking about social media and its uses in clinical practice and research. The message was clear — patients are clamoring for interactions with physicians through forums, blogs, Twitter, Facebook, etc., which all provide a unique opportunity to engage in meaningful dialogue with our patients. Social media can also be used to recruit patients into studies and might even become an avenue to coordinate follow-up and tracking in a clinical trial . Still, social media would need to be carefully handled to avoid introducing bias into the trial (e.g., discovery of treatment arm, placebo effect, or safety monitoring). Nevertheless, I think each practicing physician, should make efforts to incorporate social media as a routine part of clinical practice.
How can you take an idea from design to market? Paul Yock presented interesting examples from Stanford’s unique Biodesign fellowship, which brings clinicians together with engineers, scientists, and others to design novel solutions for the clinical needs in medicine. A group of Biodesign fellows spend time in the clinical arena and must create a list of 200 “needs” in medicine based on their observations. The needs are narrowed down; a minimum of three solutions are designed for the clinical need, and then the winning solution is created, modified, patented, and brought to market. This Biodesign paradigm represents a fantastic model for innovation because it organizes a group of like-minded individuals from diverse fields to work systematically to design solutions to common problems.
What is the potential role for the cardiology intensivist? David Morrow shared his sign-out list from the CICU at Brigham, which was quite reminiscent to my own experience in the CCU during fellowship. Most patients on his sign-out list had a cardiac history but were in the CICU for non-cardiovascular complaints that are typically seen in the MICU. After hearing his discussion, I understood that we must fill the educational void and be able to handle the complexities of managing patients who are critically ill regardless of the reason for admission to the CICU. Dr. Morrow was the first author on a recent AHA scientific statement published in Circulation on this topic. The current options for further training are to complete an additional year of critical care training (i.e., traditional 1-year fellowship) or to complete a dedicated critical care cardiology fellowship. Regardless of the pathway, the training period would be 48 months total. Brigham is currently piloting a dedicated critical care cardiology fellowship.
What sorts of unique approaches to clinical practice and research have you thought about?
For more of our ACC.13 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Headquarters.
March 11th, 2013
Diversity in Cardiology: Blogging from ACC.13
Tariq Ahmad, MD, MPH
Several Cardiology Fellows who are attending ACC.13 in San Francisco this week are blogging for CardioExchange. The Fellows include Tariq Ahmad, Megan Coylewright, Jeremiah Depta, Kumar Dharmarajan, Payal Kohli, and Sandeep Mangalmurti. View the previous post here and the next one
If the people who attend ACC are a good representation of the cardiologists of the world, then we certainly are in need of more diversity. There are few women and minorities, especially at the leadership level.
I would often get a sense of this during our conferences in fellowship, when the number of women were far outnumbered by the men, and sometimes we would have ratios of >15:1. Compared to other subspecialties of medicine, cardiology has longer training, and the work can be quite taxing, especially if one takes the invasive route and/or wants to start a family.
I feel a deep sense of respect and admiration of my female colleagues who juggle having children and caring for them while completing a challenging fellowship.
Along with being a CardioExchange blogger, I also run the Duke cardiology fellowship blog. Therefore, I brought this issue up with one of my co-fellows, Dr. Prateeti Khazanie. We came up with the idea of interviewing some of the women who are “greats” in cardiology to get their perspective. The list of interviewees continues to grow, and we have already interviewed the likes of Drs. Lynn Stevenson, Maggie Redfield, Judith Hochman, and Mariell Jessup.
What do you think the ACC can do to increase diversity?
Instead of continuing to increase the years of training, should cardiologists try to make fellowship “smarter” so people from all backgrounds can join our ranks?
More diversity in cardiology would surely lead to better care for our patients.
For more of our ACC.13 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Headquarters.
March 11th, 2013
The Human Touch After Hours and Between Sessions: Blogging from ACC.13
Tariq Ahmad, MD, MPH
Several Cardiology Fellows who are attending ACC.13 in San Francisco this week are blogging for CardioExchange. The Fellows include Tariq Ahmad, Megan Coylewright, Jeremiah Depta, Kumar Dharmarajan, Payal Kohli, and Sandeep Mangalmurti. View the previous post here and the next one
One of my co-fellows from Duke, Priyesh Patel, made a comment tonight about the meeting that really resonated: ACC seems to be more about what happens after the sessions than the sessions themselves.
The last two days have been a whirlwind of activity. My days have been filled with running between sessions that interested me, sitting in on some to provide moral support to co-fellows and friends, and presenting my own research. However, the “highest yield” activities have involved having lunch, dinner, and drinks with friends and collaborators.
This may be an important reason why meetings like ACC are unlikely to ever become obsolete. Although the lectures and the posters can be accessed online, the unmeasured gains that result from human interactions cannot occur in cyberspace.
Todays highlights included a great discussion on the emerging field of cardio-oncology. With the explosion in cancer therapeutics, and the potential for significant cardiotoxicity, it will likely become more important for cardiologists to advice and manage patients undergoing chemotherapy. There is some talk about this becoming a subspecialty.
I presented a research poster this afternoon on biomarkers in heart failure and then rushed to try and “Stump the Professor.” It was great fun to present a case to two great clinicians—Pat O’Gara and Tom Bashore—who have taught me much of what I know about cardiology.
Afterwards, my co-fellows and I went to dinner with two of my favorite mentors at Duke: Adrian Hernandez and Manesh Patel. It was great to get to know them on a more personal level. Much of medical training in spent paying respect to a strict hierarchy, and these meetings allow for mentors and mentees to interact as peers.
Breaking down these barriers makes our job all the more fun.
For more of our ACC.13 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Headquarters.
March 11th, 2013
Devices vs. Drugs: A Distinction Without a Difference? Blogging from ACC.13
Sandeep Mangalmurti, MD, JD
Several Cardiology Fellows who are attending ACC.13 in San Francisco this week are blogging for CardioExchange. The Fellows include Tariq Ahmad, Megan Coylewright, Jeremiah Depta, Kumar Dharmarajan, Payal Kohli, and Sandeep Mangalmurti. View the previous post here and the next one
One of the most enjoyable aspects of cardiology is the “toys.” Even as someone who doesn’t implant devices or deploy stents, I appreciate the technologic complexity that they have achieved. However, I hadn’t fully appreciated their associated regulatory complexity. In addition to the issues mentioned in my last posting, yesterday’s symposium entitled “Regulatory Oversight and Protection of Patients’ Interests” offered an eye opening discussion of how differently medical devices are regulated compared with drugs.
The Food and Drug Administration’s (FDA) legal authority to regulate pharmaceuticals comes from the Food, Drug and Cosmetics Act of 1938. Initially, this act did not cover medical devices; FDA regulation of devices did not begin until 1976, prompted by the injuries caused by the Dalkon Shield. In empowering the FDA to regulate devices, Congress set up two different routes for device approval. The first, premarket approval (PMA), parallels the approval process for drugs. Like pharmaceuticals, devices are to undergo rigorous testing before becoming made available to the public. However, in order to grandfather in devices that were already in existence in 1976, a second route known as the “510(k) provision” was developed. Under this route, a device need only show that it is “substantially similarly” to a device already on the market in 1976. The intent of 510(k) was to allow manufacturers to continue to improve these devices without having to begin from regulatory square one.
The 510(k) was meant as an accessory pathway, but due to loosening of the definition of “substantially similar,” the tail is now wagging the dog. Less than 1% of devices are cleared through the rigorous PMA route; instead, new devices with only a tenuous similarity to their predecessors are routinely cleared for general use. For a great case study of this process at work, see “The 510(k) Ancestry of a Metal-on-Metal Hip Implant” Ardaugh B, et al. N Engl J Med 2013;368:97-100. Unfortunately, the 510(k) shortcut has resulted in a significant number of substandard products reaching the market, and then facing recall. In 2011, the Institute of Medicine recommended the FDA move away the 510(k) clearance process, as it does little to ensure device safety or efficacy.
For more of our ACC.13 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Headquarters.
March 11th, 2013
Hoping for Good Data from Partner II B: Blogging from ACC.13
Megan Coylewright, MD MPH
Several Cardiology Fellows who are attending ACC.13 in San Francisco this week are blogging for CardioExchange. The Fellows include Tariq Ahmad, Megan Coylewright, Jeremiah Depta, Kumar Dharmarajan, Payal Kohli, and Sandeep Mangalmurti. View the previous post here and the next one
The TAVR session Sunday morning walked the walk on the need for multidisciplinary teams. The panel was composed of a nurses, interventionalists, and surgeons. They addressed bail out strategies, focusing mostly on vascular catatrophes. I hope the data from PARTNER II B presented today moves us forward quickly so we don’t have to continue to subject our patients to our outdated commercial sheath sizes.
For more of our ACC.13 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Headquarters.
March 10th, 2013
Was Atherosclerosis the Real Curse of the Mummy?
Larry Husten, PHD
For more of our ACC.13 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Headquarters.
From a growing evidence base of mummies, researchers are now concluding that atherosclerosis may have been common in people who lived in premodern times. A new study presented at the ACC meeting in San Francisco and published simultaneously in the Lancet appears likely to challenge the common belief that atherosclerosis is largely a phenomenon of the modern era.
Several years ago investigators first reported finding evidence of atherosclerosis in 20 of 44 Egyptian mummies. Now an international group of researchers has extended this research and performed whole-body CT scans on 137 mummies from four different places and times — ancient Egypt, ancient Peru, southwest America, and the Aleutian Islands.
Probable or definite atherosclerosis was observed in 34% (47) of the 137 mummies:
- 38% (29 of 76) from ancient Egypt.
- 25% (13 of 51) from ancient Peru
- 40% (2 of 5) from Ancestral Puebloans
- 60% (3 of 5) from Unangan hunter gatherers
Atherosclerosis was found in a variety of vascular beds and was correlated with the age of the mummy at the time of death. The authors wrote:
“Our findings greatly increase the number of ancient people known to have atherosclerosis and show for the first time that the disease was common in several ancient cultures with varying lifestyles, diets, and genetics, across a wide geographical distance and over a very long span of human history. These findings suggest that our understanding of the causative factors of atherosclerosis is incomplete, and that atherosclerosis could be inherent to the process of human aging.”
Although the populations from which the mummies came did not smoke cigarettes, the authors point out that “the need for fire and thus smoke inhalation could have played a part in the development of atherosclerosis.” They also speculate that high levels of infections might have contributed to the development of atherosclerosis in this population.
March 10th, 2013
Another Negative Trial of Darbepoetin Alfa
Larry Husten, PHD
For more of our ACC.13 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Headquarters.
Once again a trial testing the erythropoiesis-stimulating agent darbepoetin alfa (Aranesp, Amgen) has produced a negative result. Results of the RED-HF (Reduction of Events by Darbepoetin Alfa in Heart Failure) trial were presented at the ACC in San Francisco and published simultaneously in the New England Journal of Medicine.
A total of 2278 patients with systolic heart failure and mild-to-moderate anemia were randomized to darbepoetin alfa (Aranesp, Amgen) or placebo. As expected, treatment with darbepoetin alfa significantly improved hemoglobin levels. However, no significant improvements in outcomes were associated with darbepoetin alfa.
The primary endpoint — all cause mortality or hospitalization for worsening heart failure — occurred in 50.7% of the darbepoetin alfa group and 49.5% of the placebo group (HR, 1.01; 95% CI, 0.90-1.13; P=0.87). Strokes occurred in 3.7% of the darbepoetin alfa group and 2.7% of the placebo group (HR, 1.33; 95% CI, 0.83-2.12; P=0.23). The RED-HF investigators noted that this observation was consistent with an elevated risk for stroke associated with darbepoetin alfa found in the TREAT trial of patients with diabetes, chronic kidney disease, and anemia.
A similar number of adverse events took place in each group, but a significant excess of embolic and thrombotic events occurred in the darbepoetin alfa group (13.5% vs. 10.0%; P=0.01).
The authors conclude that “our findings suggest that the hemoglobin level, like other surrogates, is simply a marker of poor prognosis in heart failure rather than a therapeutic target.” The trial, they write, does “not support the use of darbepoetin alfa in patients with systolic heart failure and mild-to-moderate anemia.”
March 10th, 2013
A Renaissance for the Poster: Blogging from ACC.13
Kumar Dharmarajan, MD MBA
Several Cardiology Fellows who are attending ACC.13 in San Francisco this week are blogging for CardioExchange. The Fellows include Tariq Ahmad, Megan Coylewright, Jeremiah Depta, Kumar Dharmarajan, Payal Kohli, and Sandeep Mangalmurti. View the previous post here and the next one
Great energy at the poster sessions this year! ACC’s decision to concentrate posters into a smaller area than in years past and place them in the Expo hall has definitely increased the foot traffic and led to a much better experience for the presenters. I bet we’re also seeing an increase in the the social capital generated by interacting around posters. Let’s hope this is the start of a new trend at both ACC and elsewhere!
For more of our ACC.13 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Headquarters.
March 10th, 2013
Eplerenone May Help Prevent Heart Failure in Acute STEMI Patients
Larry Husten, PHD
For more of our ACC.13 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Headquarters.
A new trial presented at the ACC in San Francisco suggests that the mineralocorticoid-receptor antagonist eplerenone (Pfizer, Inspra) may help prevent the development of heart failure when given acutely to STEMI patients without preexisting heart failure.
In the REMINDER trial, 1012 STEMI patients were randomized to receive eplerenone or placebo. After 10.5 months of follow-up, the primary endpoint — the time to CV mortality, rehospitalization or extended initial hospital stay due to diagnosis of HF, sustained ventricular tachycardia or fibrillation, LVEF ≤40% after 1 month, or an elevation of BNP/NT-proBNP after 1 month — occurred in 18.4% of the eplerenone group versus 29.6% of the placebo group (adjusted HR, 0.581; 95% CI, 0.449-0.753; P<0.0001).
BNP elevations occurred in 16% of the eplerenone group versus 25.9% of the placebo group (adjusted HR; 0.584; 95% CI, 0.441-0.773; P<0.0002). Significantly more patients in the eplerenone group had elevasted or low levels of potassium, but the overall rate of adverse events was similar in both groups.
The authors concluded that “the early addition of eplerenone to standard therapy has a beneficial effect on heart failure related morbidity in patients presenting with acute STEMI without HF when initiated within the first 24 hours of symptom onset.”
“This is the first randomized trial to test a mineralocorticoid receptor agonist during the acute phase of heart attack, and the results suggest a clinical benefit,” said Gilles Montalescot, lead investigator of the study, in an ACC press release.
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