February 5th, 2015
The ABIM’s Maintenance of Certification Program: What’s Next?
John Ryan, MD
This week the American Board of Internal Medicine (ABIM) made a public apology as it announced major changes to its maintenance of certification (MoC) program, including a 2-year suspension of its practice assessment, patient voice, and patient safety requirements. As we know, during the past year controversy has been swirling about the ABIM and the planned recertification every two years. However, with this new apology from the ABIM, I don’t know what happens next.
I don’t need an apology. I need a plan. I need to know that the folks caring for me, my family, and my patients are up to snuff. As providers, we all want a way to self-govern and to make quality improvement integral to our professional lives. That’s my goal, at least. I don’t care about the condo (see this Dr. Wes blog post for background). I don’t care that there’s a new board. I just want to do my job and have a plan in place so that standards are high.
Toward that end, I was ready to do my patient surveys. I was even ready to do my quality improvement! But now I don’t know what I’m going to do. Now I have no plan for the next 2 years.
That said, bigger things are going on in the world and in my life, but it would have been nice to have at least this issue squared away. Instead we are left in a state of limbo while this gets figured out.
JOIN THE DISCUSSION
Are you maintaining your composure as you confront the new announcement about MoC?
February 5th, 2015
New Percutaneous Device Offers Hope in Refractory Angina
Larry Husten, PHD
An entirely predictable consequence of medical progress is the growing number of heart patients with persistent and symptomatic angina who have run out of treatment options. A small new study published in the New England Journal of Medicine raises the possibility that a new device one day may provide them some relief. The experimental device, a coronary sinus reducer system, is delivered through a catheter to the coronary sinus, where the device is then expanded with a balloon, blocking flow through most of the vessel except for a small central orifice. Once in place the device causes an increase in coronary sinus pressure that appears to relieve angina, though the authors acknowledge that the “physiological rationale for a beneficial effect… remains unclear.”
Investigators in the Coronary Sinus Reducer for Treatment of Refractory Angina (COSIRA) trial studied 104 patients with CCS class III or IV angina who were not considered suitable candidates for revascularization. Patients were randomized to the device or a sham procedure. Only the team in the cath lab was aware of the treatment assignment.
The device was successfully implanted in 50 out of the 52 patients in the treatment group. The primary endpoint, an improvement of at least two CCS classes at 6 months, was reached in 18 of 52 patients in the treatment group compared with 8 of 52 patients in the control group (35% versus 15%, p=0.02). Mean CCS class went from 3.2 to 2.1 in the treatment group and from 3.1 to 2.6 in the control group (p=0.001).
An improvement of at least one CCS class occurred in 71% of patients in the treatment group versus 42% of the control group. Quality of life, as measured by the Seattle Angina Questionnaire, was also improved more in the treatment group, but there were no significant differences in angina stability or frequency. Exercise duration increased by 59 seconds in the treatment group versus 4 seconds in the control group.
In an accompanying editorial, Christopher Granger and Bernard Gersh write that the study was “well performed and showed significant improvements in reducing angina and improving quality of life.” Its chief limitations are its small size and the possibility that patients or physicians may have become unblinded during the trial. “If confirmed in subsequent trials, coronary-sinus reducing therapy may be a welcome and needed addition to the options to improve the quality of life of patients with refractory angina.”
Commenting on the study, John Spertus said that despite the limitations of the study its results are plausible. “The study design is about as good as can be done for something like this,” he said. He was struck by the “large and impressive” improvement in quality of life.
February 4th, 2015
Clinical Significance of Non-IRA Disease in STEMI Patients
Beat J. Meyer, M.D.
This post is adapted from Dr. Meyer’s NEJM Journal Watch summary of an article recently published in the Journal of the American Medical Association.
Recent findings from a very large dataset suggest that obstructive non–infarct-related artery (IRA) disease is common among patients with STEMI and associated with increased mortality. Whether non-IRA lesions should be treated directly during the index admission, by a staged procedure 4 to 6 weeks later, or with optimal medical therapy (as suggested by the COURAGE trial) is a controversy that this study does not resolve. Unfortunately, the setting in which this decision takes place does not lend itself well to shared decision making with the patient — and as long as the decision is based on the opinion of any particular doctor, variations in clinical practice are likely to persist. Moreover, unless better invasive and noninvasive markers are identified to allow more-reliable identification of individual CAD progression (i.e., plaque burden and individual vulnerability), most physicians will continue to rely on coronary angiography findings for their management decisions, despite modest clinical benefits and increased costs.
What strategy do you currently favor for managing obstructive non-IRA lesions? Are these new findings likely to change your approach?
February 4th, 2015
To Shock or Not to Shock — That Is the Question
Joseph G Akar, MD/PhD and Jehad Al Buraiki, MD
About 25% of candidates for cardiac resynchronization therapy (CRT) experience spontaneous reverse remodeling, according to an analysis of the MADIT-CRT study published last year in Circulation: Heart Failure. We now present two perspectives: one from Dr. Jehad Al Buraiki, Director of the Heart Center at King Faisal Specialist Hospital in Riyadh, Saudi Arabia, and another from Joseph G. Akar, Academic Director of Electrophysiology at the Yale School of Medicine in New Haven, Connecticut. The use of CRT-pacemakers is negligible in the U.S. but substantial on the other side of the Atlantic.
Al Buraiki: Management of implantable cardioverter-defibrillators (ICDs) in patients whose LV dysfunction resolves is very challenging and raises tough questions. When is it safe to recommend removal of an ICD in a patient whose LV ejection fraction (LVEF) normalizes? Should an ICD be replaced when the battery voltage depletes in such patients?
Akar: It is instinctively a lot harder to remove an ICD than insert it. Unless you are certain that the initial diagnosis leading to the ICD was erroneous, once an ICD is implanted, no absolute measures ensure safe removal, even if the LVEF completely normalizes.
Al Buraiki: This is exactly why we should be prudent before inserting an ICD. Once implanted, it tends to self-perpetuate. So when do you consider a CRT-pacemaker (CRT-P) rather than a CRT-defibrillator (CRT-D)?
Akar: This is particularly thorny because of the large overlap in clinical indications for CRT-Ps and CRT-Ds, as well as our poor ability to predict CRT responders. So in the U.S. we tend not to use CRT-P because most of these patients also have a defibrillator indication.
Al Buraiki: Our take is quite different. Both CRT-P and CRT-D can affect survival, but they have not been compared head-to-head. Given that patients with advanced heart failure tend to die from progressive pump dysfunction (rather than sudden cardiac death), one must question the incremental benefit of CRT-D over CRT-P. This is particularly true of patients who tend to benefit exceptionally from CRT-P, such as those with nonischemic cardiomyopathy and wide left bundle-branch block. It is also relevant for populations in whom defibrillators are not clearly proven to affect survival, such as the very elderly and patients with renal failure. In fact, for the majority of advanced heart failure patients who are not transplant candidates, sudden cardiac death may actually be more comfortable and humane than progressive pump failure. Multiple defibrillator shocks only make things worse for a patient whose quality of life is the major therapeutic objective. CRT-P improves quality of life and survival without the risk for inappropriate shocks.
Akar: I do not disagree with what you said. It is vitally important to fully engage patients in their clinical care and therapeutic goals when choosing a device, and nonclinical considerations (e.g., cultural, economic, and medico-legal factors) undoubtedly account for the transatlantic differences implantation patterns. Given the large overlap in guideline indications for CRT-P and CRT-D, U.S. physicians usually opt for CRT-D. So it will be crucial for us to distinguish between patients who are best suited for each modality, and to identify patients whose LV function will spontaneously improve and therefore may not need either device. Until that happens, however, we may need to start making some tough choices in an era of increasing economic constraints and limited healthcare dollars, because a strategy of nonselective insertion of a CRT-D is simply not viable from a healthcare economics standpoint.
JOIN THE DISCUSSION
Where do you stand in the CRT-pacemaker versus CRT-defibrillator debate?
February 2nd, 2015
Selections from Richard Lehman’s Literature Review: February 2nd
Richard Lehman, BM, BCh, MRCGP
CardioExchange is pleased to reprint this selection from Dr. Richard Lehman’s weekly journal review blog at BMJ.com. Selected summaries are relevant to our audience, but we encourage members to engage with the entire blog.
NEJM 29 January 2015 Vol 372
Less-Tight v.s Tight Control of Hypertension in Pregnancy (pg. 407): A Canadian trial tells us a bit more about how to treat raised blood pressure in pregnancy. If women already have elevated BP or acquire it before 34 weeks of gestation without proteinuria, treating to a target diastolic of 100 mm Hg produces the same result as treating to a target of 85, in terms of pregnancy loss, high level neonatal care, or overall maternal complications. Naturally, those treated less intensively show a greater tendency for their BP to rise as the pregnancy continues.
A Randomized Trial of Icatibant in ACE-Inhibitor–Induced Angioedema (pg. 418): Huge numbers of people now take angiotensin-converting enzyme inhibitors, and a few of them get angio-oedema as a result, which can happen even after years of use. As far as I could ascertain, fatalities are very rare and exclusive to people of African origin. I get mild angio-oedema now and again, though I’m not on an ACE inhibitor. I take an antihistamine and wait for it to go away. So, I guess, do most people: the treatment cost must be about 10p. Shire makes a competitor drug called icatibant, which in the USA costs between $5000 and $10 000 per shot. They have run a trial (n=27) to show that it works faster in ACEI-related angio-oedema than standard hospital treatment with intravenous prednisolone and clemastine—eight hours rather than 27. I can see this being kept in the back locker for those rare people with real airways compromise, rather than people like me with the occasional thick lip.
JAMA Intern Med January 2015
Comparative Effectiveness of Diagnostic Testing Strategies in Emergency Department Patients With Chest Pain (OL): This important study shows that people who are privately insured and attend an American hospital with chest pain, and undergo immediate investigations which are negative for myocardial infarction, still get later non-invasive testing in a third of cases. These patients had the same subsequent very low incidence of myocardial infarctions as the non-tested group, but were of course much more likely to proceed to invasive testing. “Compared with no testing, exercise electrocardiography, myocardial perfusion scintigraphy, and coronary computed tomography angiography were associated with significantly higher odds of cardiac catheterization and revascularization procedures without a concomitant improvement in the odds of experiencing an MI.” I don’t know how much of this goes on in the UK, but it is time it stopped.
Lancet 31 January 2015 Vol 385
ST-Segment Elevation Myocardial Infarction in China from 2001 to 2011 (pg. 441): China has the wealth to sort out its own health problems, but first it must know how to map them. With names like Krumholz, Spertus, and Masoudi on the case, it can hardly fail to make progress with mapping their cardiovascular outcomes, as this study of ST-segment elevation myocardial infarction in China from 2001 to 2011 illustrates. But wait a moment: after the paper had gone online, somebody discovered a miscalculation in the weight of one of the urban areas in the study. It made no substantive difference to the conclusions, but when the authors reported it to the Lancet, the journal proceeded to retract the paper rather than publish a small correction. Now that the corrected paper has appeared in print, the Lancet takes the opportunity to congratulate itself on this noble deed.
January 29th, 2015
FDA Approves Right Percutaneous Single Access Heart Pump
Larry Husten, PHD
Abiomed has announced that it received FDA approval for its Impella RP System, the first percutaneous single access heart pump that provides support to the right side of the heart. The approval, under a Humanitarian Device Exemption (HDE), is based on results of the single-arm Recover Right study, in which 30 patients were enrolled. The overall survival rate was 73% at 30 days.
The device is indicated to provide circulatory support for as long as 14 days to pediatric or adult patients with acute right heart failure or decompensation after implantation of an LVAD, MI, heart transplant, or open-heart surgery. The Impella RP provides up to four liters per minute of hemodynamic support, according to the company.
Abiomed said the device would undergo a “controlled launch” and would be available only after sites complete a rigorous training course involving the heart team from each institution, “including the interventional cardiologist, cardiac surgeon, heart failure cardiologist and lead nurse.”
The FDA is requiring Abiomed to perform post-approval studies in 30 adult patients and up to 15 pediatric patients. The single-arm studies will follow patients at 30 days and 180 days after device explant.
The Boston Globe reported that the company plans to initiate follow-up testing that could potentially significantly expand the patient population eligible to receive the device.
January 28th, 2015
Tight Control of Hypertension During Pregnancy Tested
Larry Husten, PHD
High blood pressure during pregnancy is increasingly common, largely due to older age and obesity. Although there is widespread agreement that hypertension in these women should be treated when it is high enough to raise the risk of stroke, there is little agreement about whether or how to treat mild hypertension.
In a study reported in the New England Journal of Medicine, investigators from Canada reported on 986 hypertensive pregnant women who had diastolic blood pressure of 90 to 105 mm Hg (or, for women already taking a blood pressure drug, 85 to 105 mm Hg). The women were randomized to less tight blood pressure control (target diastolic blood pressure, 100 mm Hg) or tight blood pressure control (target, 85 mm Hg). Three-quarters of the women had hypertension predating their pregnancy.
Blood pressure was 4.6 mm Hg lower in the tight group. However, there were no significant differences in the primary outcome of the trial, which was the loss of the pregnancy or the need for intense neonatal care in the 4 weeks after birth ( (31.4% in the less tight group versus 30.7% in the tight group). Also, no significant differences in serious maternal complications were observed. However, severe hypertension occurred significantly more often in the less tight group than in the tight group (40.6% versus 27.5%, p < 0.001), although this was not accompanied by an increase in stroke or other serious complications.
In an accompanying editorial, Caren Solomon and Michael Greene write that the study “showed that tight control of hypertension conferred no apparent benefits to the fetus and only a moderate benefit (a lower rate of progression to severe hypertension) for the mother. It does, however, provide valuable reassurance that tight control, as targeted in this study, does not carry major risks for the fetus or newborn.”
January 28th, 2015
Icatibant Is Effective in Patients with ACE Inhibitor–Induced Angioedema
CardioExchange Editors, Staff
Icatibant, a selective bradykinin B2-receptor antagonist approved for hereditary angioedema, is associated with 70% faster resolution of ACE inhibitor–induced angioedema than usual care, a phase II trial in the New England Journal of Medicine finds.
Nearly 30 adults presenting within 10 hours of onset of ACE inhibitor–induced angioedema of the upper aerodigestive tract were randomized to subcutaneous injection of icatibant or usual therapy (intravenous prednisolone plus the antihistamine clemastine).
Median time to full resolution of angioedema was shorter in the icatibant than the usual-care group (8 vs. 27 hours); five icatibant patients (38%) had full symptom resolution within 4 hours, compared with no usual-care patients. The only adverse events in the icatibant group were injection-site reactions.
Although this was a small, phase II trial, the results were very impressive. Icatibant is extremely expensive (>US$8000 per 30-mg dose), but if it can prevent an ICU stay or tracheotomy, it will be worth the high cost.
–By David Amrol, MD
Dr. Amrol is a contributing editor with NEJM Journal Watch General Medicine, from which this summary was adapted.
January 27th, 2015
Can Precision Medicine Do Better Than Precision Weather?
Larry Husten, PHD
This article was originally posted on Larry’s blog at Forbes.
Looking out of my New York City window this morning at the meager 6 inches of snow on the ground I can’t help wondering if precision medicine in the foreseeable future will be able to do a better job than precision weather forecasting today.
Weather forecasters, using all the tools of modern science, blew it big time. Meteorologists thought they had enough data and sufficiently sophisticated models to accurately predict a huge snowstorm. Using this knowledge politicians and other experts thought they could prevent a major disaster from taking place. Instead they created their own disaster. Here in NYC the entire city was shut down over fears of the dangers of a once in a century blizzard.
Is the human body simpler than the weather? Will we be able to accurately predict, prevent, and treat serious diseases in the future? What are the consequences when precision medicine blows a major forecast?
Don’t get me wrong: precision medicine has a great future and is not going to disappear. But we need to think about the unintended consequences and harms it can cause. We need to be optimistic but our optimism should not be unbridled. We must try to keep in mind all the things that can go wrong.
One more thought:
Did any of the forecasters report the confidence intervals for the predicted amount of snowfall? Did Governor Cuomo have access to this information, and if he had would he have understood it? Should TV forecasters report this information? Is the situation in New York City today a consequence of scientific illiteracy?
January 26th, 2015
Isolated Systolic Hypertension in Younger Adults Linked to Increased CV Mortality
Nicholas Downing, MD
Young and middle-aged adults with isolated systolic hypertension face increased long-term risks for coronary heart disease (CHD) and cardiovascular disease (CVD) mortality, according to a study in the Journal of the American College of Cardiology.
Researchers studied some 27,000 adults in the Chicago area who were under age 50 and had their blood pressure measured at baseline (those who had pre-existing CHD or were taking antihypertensives were excluded). Roughly 25% of men and 13% of women had isolated systolic hypertension (systolic BP 140 mm Hg or higher, diastolic BP below 90).
During 31 years’ follow-up, some 1700 deaths from cardiovascular disease, 1200 from CHD, and 200 from stroke occurred. After multivariable adjustment, isolated systolic hypertension was associated with increased risks for CHD and CVD mortality, relative to normal-optimal blood pressure. For example, men with isolated systolic hypertension had a 28% increased risk for CHD mortality, while women had twice the risk.
Harlan Krumholz, editor-in-chief of CardioExchange, commented: “This study reaffirms years of work that higher systolic blood pressure is a marker of higher risk. Behavior interventions seem reasonable for this group, but whether lifelong antihypertensive therapy [is indicated] for mild elevations in systolic hypertension remains an open question that cannot be answered by this study.”
NEJM Journal Watch — Recent Cardiology Articles- To Lower Stroke Risk in Patients Undergoing Atrial Fibrillation Ablation, Is a Device or a Medication Better?
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- Anticoagulation in Patients with Cancer-Associated Pulmonary Embolism: How Long is Long Enough?
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