June 23rd, 2011
Advice for New Cardiology Fellows — Part 2: Reading and Research
John Ryan, MD, Andrew M. Kates, MD and James De Lemos, MD
With July just around the corner and a new generation of cardiologists about to start their training, the CardioExchange editors have asked the fellowship moderators to share their advice about how to face this exciting new challenge. We bring you that advice in a three-part series through the end of June. Part 2 focuses on Reading and Research.
What should fellows be reading?
John Ryan (current fellow): I find Braunwald to be the best resource. I don’t think you can read it from cover to cover. Instead, make a note of the questions or clinical scenarios that you have been presented during the day and then read up about them in the evening after work.
Andy Kates (fellow from 1997 to 2001): There is no substitute for self-motivated reading. This is as true for an attending as it is for fellows. Didactic instruction cannot replace the reinforcement that comes from reading about the basics of, say, aortic stenosis after you see a patient with AS. Texts like Braunwald offer those basics, which the core lectures that most programs provide to fellows then reinforce. It helps to do focused reading on a topic the day before the lecture (e.g., reviewing a chapter from the echo text on MR before an echo MR lecture). I also remind fellows that it takes reading material several times before one “gets it.” Lastly, point-of-care learning (e.g., PubMed) is essential, so never hesitate to look up rare entities or even the basics as you see a patient, in either the inpatient or the outpatient setting.
James de Lemos (fellow from 1996 to 1999): A disciplined reading plan is crucial. I agree with John that Braunwald (or an equivalent such as Topol or Hurst) should be your core reading material. I would suggest case-directed reading to learn the basics about the patients you have seen. This should be done in “real time,” even when you’re tired, because it won’t stick if you wait a few days. You also need a regular reading schedule that is not case-based to fill in gaps and to learn the core concepts for each rotation. For example, you must read Feigenbam or another echo book while on echo, a core cath book on cath, etc. For interesting cases, focused literature searches and reviews are very important, and learning to do this quickly and efficiently is an important skill you should work to develop. Remember that as useful as they are, the textbooks are always out of date for rapidly changing areas.
When should fellows get involved in research?
Ryan: The first clinical year is so overwhelming that I think it is very tough to get involved in research, and I also don’t think it is necessary. The priority is to develop the skills of a clinical cardiologist. However, once fellows do get settled in, some take the opportunity to write review articles or case reports, but again only to complement clinical training, not at the expense of it.
Kates: Our fellows are encouraged to explore research options during their first year of training, although the demands of the first clinical year make this difficult for many. Some of our fellows (such as those who are part of the Physician Scientist Training Program) have already developed research interests. For others, though, it is primarily during the first six months of second year that they begin to form a research proposal, which is then formalized (e.g., IRB approval, statistical powering) by the beginning of third year. All of our fellows are expected to engage in scholarly activity, and I believe it helps them regardless of their ultimate career pathway.
de Lemos: This decision differs greatly from fellow to fellow. I do think that fellows should work to learn principles of cardiovascular research during the first year, including critical interpretation of the literature, basic study design and analysis, etc. I also think that toward the latter half of the first year, the fellows should try to have an idea of whom they would like to select as a research mentor, and set up meetings to talk about research with a number of potential mentors. If you wait until the end of the second year to pick a mentor, it is often too late.
What reading resources would you recommend to fellows? And what are your thoughts about getting involved in research as a fellow?
June 22nd, 2011
Apixaban (Eliquis) Meets Primary Endpoint in ARISTOTLE
Larry Husten, PHD
Pfizer and Bristol-Myers Squibb said that their new oral direct Factor Xa drug apixaban, which will be marketed under the brand name of Eliquis, had met the primary endpoint of the ARISTOTLE study.
The Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE) study was designed to compare the factor Xa inhibitor apixaban with warfarin for the prevention of stroke and systemic embolism in atrial fibrillation (AF) patients with additional risk factors for stroke. The primary outcome was the time to first occurrence of either stroke or systemic embolism. According to the companies, apixaban met the criteria for noninferiority to warfarin in the trial.
The companies also said that apixaban had met the trial’s secondary endpoint, demonstrating superiority to warfarin for efficacy and major bleeding, defined as the combined rate of ischemic stroke, hemorrhagic stroke, systemic embolism, and all cause death.
Detailed results of ARISTOTLE will be presented at the European Society of Cardiology Congress 2011 in Paris on August 28.
June 22nd, 2011
JAMA: Skeptical Perspectives on Consumer Cardiac Tests and Vitamin D
Larry Husten, PHD
Two commentaries published in JAMA offer skeptical perspectives on the roles of direct-to-consumer (DTC) cardiac tests and vitamin D in cardiovascular health.
In the first commentary, Kimberly Lovett and Bryan Liang write that DTC screening tests “likely pose more risk than benefit to patients,” and point out that for companies selling these tests there is no requirement “for full disclosure in advertising, informed consent, pretest evaluation, or posttest counseling.” Some screening tests, including tests for carotid artery stenosis, peripheral artery disease, atrial fibrillation, and abdominal aortic aneurysm, are not recommended for most people by organizations like the USPSTF and the ACC/AHA. Other tests, like CRP, lipid tests, and coronary calcium, have received limited endorsements, but only in carefully selected patients, the authors write.
They recommend that the FDA regulate consumer screening tests, that the companies provide pretest consultation with a qualified professional, and that DTC tests be included in the FDA Medwatch database.
In the second commentary, Sue Shapses and JoAnn Manson, who served on the Institute of Medicine committee on vitamin D, explain why the role of vitamin D in heart disease, stroke, hypertension, and diabetes played only “an inconsequential role in determining the population needs for vitamin D” in the recent IOM report.
Shapses and Manson acknowledge the “biological plausibility for a role of vitamin D in the prevention of cardiovascular disease and diabetes” but, citing deficiencies in both observational and randomized evidence, they conclude that “the evidence from available research is inconsistent, inconclusive as to causality, and not sufficient to inform nutritional requirements.” Several ongoing randomized trials may provide better evidence within 5 to 6 years, they write.
June 21st, 2011
Meta-Analysis Examines Risk of Diabetes Associated with Statins
Larry Husten, PHD
Although the cardiovascular benefits of statin therapy are well-characterized, recent studies have raised concerns that intensive statin therapy increases the risk for developing type 2 diabetes. Now, a new meta-analysis published in JAMA provides a more precise estimate of the risk for diabetes associated with statin therapy and also weighs that risk against the cardiovascular benefits of statins.
David Preiss and colleagues analyzed data from 5 clinical trials (PROVE IT-TIMI 22, A to Z, TNT, IDEAL, and SEARCH) that compared intensive-dose statin therapy with moderate-dose statin therapy. The trials randomized 32,752 subjects who did not have diabetes at baseline.
- 2749 patients developed diabetes during the trial: 8.8% in the intensive-dose groups vs. 8.0% in the moderate-dose groups (OR 1.12; 95% CI, 1.04-1.22).
- 6684 patients had cardiovascular events: 19.1% in the intensive-dose groups vs. 21.7% in the moderate-dose groups (OR 0.84; 95% CI, 0.75-0.94).
The authors calculated that intensive statin treatment resulted in:
- 2 additional cases of diabetes per 1000 patient-years, representing a number needed to harm of 498 per year to cause 1 case of diabetes; and
- 6.5 fewer first major CV events per 1000 patient-years, representing a number needed to treat of 155 to prevent 1 CV event per year.
In their conclusion, the authors speculate that “given that cardiovascular risk from diabetes is modest in the first decade after diagnosis, and as the benefit of statin therapy increases over time and in absolute terms with increasing age, net cardiovascular benefit in high-risk individuals will still strongly favor statin therapy.”
June 21st, 2011
Study Finds Critical Delay in Most MI Patients Transferred for Primary PCI
Larry Husten, PHD
MI patients who arrive at hospitals unable to perform primary PCI need to be promptly transferred to another hospital in order to receive the full benefits of reperfusion. Unfortunately, these patients often have prolonged door-to-balloon times. A key element in the delay is the time spent at the first hospital, referred to as the door-in to door-out (DIDO) time. A new study published in JAMA demonstrates that a DIDO time of 30 minutes or less is associated with shorter reperfusion delays and lower in-hospital mortality, but the study also shows that only a small proportion of patients are currently transferred this rapidly.
Using registry data on 14,821 patients with STEMI who were transferred to 298 hospitals for primary PCI, Wang and colleagues found that the median DIDO time was 68 minutes, and only 11% of patients had DIDO times within the recommended 30 minutes. The median door-to-balloon time was 85 minutes in those with a DIDO time of 30 minutes or less, compared with 127 minutes in those with longer DIDO times (P<0.001). Mortality was 2.7% in the 30-minutes-or-less group versus 5.9% in those with longer DIDO times (P<0.001). The mortality difference remained significant after adjusting for differences in baseline characteristics and presenting features between the groups.
June 20th, 2011
When the Stuff Hits the Fan
Westby G Fisher, MD
CardioExchange welcomes this guest post, reprinted with permission, from Dr. Westby Fisher, an electrophysiologist practicing at NorthShore University HealthSystem in Evanston, Illinois, and a Clinical Associate Professor of Medicine at University of Chicago’s Pritzker School of Medicine. This piece originally appeared on his blog, Dr. Wes.
Easy case.
Seen it a hundred times.
Old guy (or gal).
Comes into ER.
Found “down.”
“Hey doc, looks like his hearts goin’ slow. I think he (or she) needs a pacer.”
“On any meds that might do this?”
“Nah.”
“How’s his (her) potassium?”
“4.3, normal.”
And like lots of times, you head in. Glad you can help. Call-team’s on their way, thanks to you. Called the device rep to make sure they can be there just in case, too. Cool as a cucumber. Nothin’ to it. Been here, done this.
You arrive to a guy (or gal) that looks pretty good. Maybe has one or two medical problems. Heart rate’s better thanks to the atropine and the fluids they gave him (her) on arrival. The intraosseus line in the tibia is impressive, too. (“At least he [she] wasn’t awake when that happened,” you think.)
So you review, examine, plan your approach. EKG on presentation? Ouch, heart rate agonal. Wide complex rhythm of right bundle branch rhythm. Look at the monitor: “lots more right bundle branch rhythm there, thank goodness, P waves, too.” you secretely notice.
Seems he (or she) is willing (how many times does he [or she] want to pass out at home?), understands what lies ahead, that the crew’s on their way. “We’ll be taking you over in just a few minutes. Any other questions?” There are none.
Perfect.
And after a while the crew arrives, assembles the poor guy (or gal) on the table and ships him (or her) over to the cath lab. Chest is prepped, equipment assembled, antibiotics given, monitors connected…
… damn we’re good. Smooth operators.
So the local anesthetic is injected and the incisions made. Dissection to the pre-pectoralis fascia just above the breast muscle accomplished, even the wires passed easily into the vein using ultrasound guidance. Even having a nice chat with the guy (or gal).
Poetry in motion.
Sheaths placed in the vein over the guidewire, pacing leads placed through the sheath. Until, from the control room…
“We lost our EKG.”
You glance up. Nothing on the monitor. Brain shifts from 33 rpm to 78 rpm, then higher….
“Okay, boys and girls, let’s find the problem. Device rep? Turn on pacing from your PSA.” You fluoro. No heart motion. Curved stylette goes into the longer lead.
“I’ve got the airway,” the nurse shouts. “Should we start CPR?”
“Not yet, moving the lead to the ventricle…”
“Crap, he’s (or she’s) moving. Seizing. Sh%^#t! Hold him on the table! Need… him… under… flouro…. just… one… more… second…”
“There! Turn on pacing!”
You look up. Pacing has begun. EKG shows capture. Your sphincter relaxes. A bit. Until beneath the surgical drape, thrashing …
“It’s okay sir (or madam)! You just passed out. Don’t try to get up off the table. You’re in surgery, remember?”
Calm ensues.
Suddenly flat line on the monitor again….
“What the?…”
You step of the flouro pedal again. Lead looks good. Moving.
“He’s still with us,” the nurse shouts. “Still got a pulse ox reading. Must had knocked off the EKG lead…”
“Come on, guys! How many changes of underwear do I need to bring for these cases? Sheesh! … Sir (or Ma’am), you doing okay?”
“Uh, yeah, doc. What… happened?…”
“You passed out again on us. Just like you did at home. It’s all good now, we got that lead in place.”
And so, as dusk settles over the horizon on another thrilling ride in the EP lab, you stop to reflect on just how lucky you and the patient were that day. By the grace of God you had access to the vein already, the lead in the right atrium, and the presence of mind and experience to position the lead to the ventricle in the nick of time.
You know others before you weren’t so lucky. You know that others, despite their best efforts, had the patient die. You know how terrifying those seconds were. You wonder if they got sued.
No fault of their own. Just fate.
So you vow from that day forward that you’ll always place a temporary pacing wire from the leg before you start an emergency case like this on the weekend.
It’s all about having control.
And reducing your underwear cleaning bills…
June 16th, 2011
Advice for New Cardiology Fellows — Part 1: The Learning Curve
John Ryan, MD, Andrew M. Kates, MD and James De Lemos, MD
With July just around the corner and a new generation of cardiologists about to start their training, the CardioExchange editors have asked the fellowship moderators to share their advice about how to face this exciting new challenge. We bring you that advice in a three-part series through the end of June. Part 1 focuses on the Learning Curve.
What advice do you have for feeling inexperienced, when you face that steep learning curve in the early days?
John Ryan (current fellow): Don’t be afraid to ask questions. I didn’t realize how little I knew about cardiology until I started fellowship. Although the skills I obtained during residency helped, nothing prepared me for that first call from the emergency department about a confusing ECG. The tombstone ECGs are easy to handle, as are the stone-cold normal ones. But the ones in between made me sweat. Senior fellows are an incredible resource here and will help you through the system until you start feeling comfortable and develop your own approach.
Andy Kates (fellow from 1997 to 2001): We don’t expect you to know everything. That’s why it’s called a training program. I find myself constantly reminding fellows that we do not expect them to come in fully trained. That’s part of our job. We do, however, expect and encourage you to ask questions. You will be surprised at how much you actually know already — but another part of our job is to help you think of those items you had not considered.
James de Lemos (fellow from 1996 to 1999): Be an active learner. Bounce ideas off your attendings, senior fellows, and even co-fellows, but decide in your mind what you would do before you ask, so that you can gauge your decision-making and judgment against those with more experience. Jump right into your patient-care rotations — you won’t learn and you won’t get comfortable if you blend into the background. Finally, remember that we (the old folks) will get mad at you only if you don’t call when you should have. We never get mad if you call to run something by us or to check that you’re doing the right thing. So, in the beginning, always call for help when you’re not absolutely sure!
What about the first on-call echo that you have to do?
Ryan: On-call echos are super-stressful. First of all, there’s the physical strain of pushing the echo machine down the hospital corridors while fretting about the body habitus of the patient you are about to image. Second, the questions are often tough to answer, such as how to evaluate RV function for PE. When doing an echo, I send all family members and physicians out of the room before I start getting images. I find it stressful enough without someone looking over my shoulder asking, “What do you see?” I feel that doing an echo is akin to doing a consult, and I approach it the same way: Look at the primary data, see what extra information can be garnered from the echo images, and give your findings as an assessment of the patient as a whole.
Kates: You have backup. We do not expect — nor do we want — a brand-new first-year fellow to do a complete, accurate echo by him or herself. On-call echos tend to be performed on the sickest patients, often intubated and with poor windows. We want you to call for help. That said, one of the more rewarding aspects of cardiology training is being able to synthesize data obtained from the echo to aid in your decision-making process for a critically ill patient.
de Lemos: Deal with this by getting comfortable with your echo skills before you have to do it on call. Ask your program for an echo “boot camp” to teach you how to obtain and record basic images, rule out major emergent conditions such as tamponade, major new wall-motion abnormalities, etc. Sneak away from other rotations during slower times in the afternoon, and do echos on your classmates to build your skills. Remember, you only need to be able to do a few things with the echo probe at night — you don’t have to do the full study!
If you are about to become a cardiology fellow or are one now, what are your thoughts and fears about the learning curve of training? If your fellowship days are history, what’s your advice to the up-and-coming and the already-immersed younger folks?
June 16th, 2011
Case Study: Advanced Heart Failure in a Prison Inmate
Tariq Ahmad, MD, MPH and James Fang, MD
A 37-year-old prisoner with end-stage nonischemic cardiomyopathy was transferred from a local county hospital to a tertiary care center for heart failure therapy. Soon after his arrival, he developed ventricular tachycardia and cardiogenic shock. He was sent urgently to the cardiac catheterization laboratory, where he underwent placement of an intra-aortic balloon pump (IABP). Right-heart catheterization, on dobutamine and IABP therapy, revealed:
- right-atrial pressure, 15 mm Hg
- pulmonary-artery pressure, 50/33 mm Hg
- pulmonary capillary wedge pressure, 28 mm Hg
- cardiac index, 1.8 L/minute/m2
Efforts to improve the patient’s hemodynamics, in order to allow weaning from the IABP, were unsuccessful.
The patient wants to avail himself of whatever treatments will keep him alive. He has been told about the possibility of heart transplantation or placement of a left-ventricular assist device (LVAD). The patient’s social worker reports that the patient is housed in a maximum-security facility without hope for parole.
Questions:
- Is this patient an appropriate candidate for an LVAD?
- Is he an appropriate candidate for heart transplantation?
- What would be the best course of action for this patient, given his complex personal circumstances?
Response:
James Fang, MD
The comments below from my colleagues all have valid points. Many will recall that a similar case in California about a decade ago received widespread attention when the prisoner ultimately received a heart transplant. Other than a successful transplant, I do not know if the patient did well over the ensuing years. Keep in mind that renal transplantation has also been performed in incarcerated patients as well.
Without more information, it is not yet clear if the patient meets the criteria for an LVAD. The psychosocial aspects are only one consideration. Other medical comorbidities, the nature and extent of medical/device therapy to date, etc. still need vetting.
Clearly, it is a complex decision as is caring for anyone with advanced heart failure. The sophisticated nature of this field has been recently recognized by our community and the ABIM which now acknowledges the cardiovascular subspecialty of advanced heart failure and transplantation. Hopefully, this patient was seen and reviewed by such a subspecialist and a multidisciplinary team well versed in these issues. Most advanced heart disease centers have multidisciplinary groups that routinely review such cases.
An LVAD strategy is increasingly being used as a “bridge to a decision” in the world of advanced heart failure and this patient could fall into this category. Arguably, compliance is less likely an issue in an incarcerated situation where the patient is under constant surveillance.
At the end of the day, it is likely that finances will drive the decision. Many non-incarcerated patients are routinely turned down for transplant and/or VAD because they have no ability to pay. Like this patient, they too generally want whatever treatments will keep them alive. It may not be fair but it is a reality.
As for other courses of action, chronic inotropic management could be used understanding its limitations. I would also revisit other options such as CRT and hemodynamic guided therapy.
June 16th, 2011
FDA: Varenicline (Chantix) May Increase Risk for CV Events
Larry Husten, PHD
The FDA said that the anti-smoking drug varenicline (Chantix) may increase the risk for cardiovascular events in people who already have cardiovascular disease. The new information will be added to the drug’s label and Medication Guide for patients.
The FDA does not recommend that people with cardiovascular disease stop taking varenicline, but it says that physicians and patients should weigh the known benefits and risks from the drug. Pfizer, the drug’s manufacturer, will be required to conduct a large meta-analysis.
The new action is based on an FDA review of a study of 700 patients with cardiovascular disease who were randomized for 12 weeks to either varenicline or placebo, followed by a 40-week nontreatment period. Varenicline use was associated with significant advantages (over placebo) in the Continuous Quit Rate during weeks 9 through12 (47% vs. 14%; P<0.0001) and in the continuous abstinence rate from weeks 9 through 52 (19% vs. 7%; P<0.0001). However, cardiovascular adverse events were more common in the varenicline arm than in the placebo arm, although the trial was not powered to detect significant differences. Here are the FDA data:
Adjudicated Cardiovascular Events During the 52-Week Study Period (≥1% in any group)
| Varenicline N=353* n (%) | Placebo N=350 n (%) | |
|---|---|---|
| Nonfatal myocardial infarction | 7 (2.0) | 3 (0.9) |
| Need for coronary revascularization† | 8 (2.3) | 3 (0.9) |
| Hospitalization for angina pectoris | 8 (2.3) | 8 (2.3) |
| New diagnosis of peripheral vascular disease (PVD) or admission for a procedure to treat PVD | 5 (1.4) | 3 (0.9) |
*Three patients in the varenicline arm did not meet the protocol-specified definition of stable cardiovascular disease but were included in the safety analysis population.
†Patients with need for coronary revascularization in the varenicline arm include 5 patients who are also counted under nonfatal myocardial infarction and/or hospitalization for angina pectoris events. Patients with need for coronary revascularization in the placebo arm include 2 patients who are also counted under nonfatal myocardial infarction and/or hospitalization for angina pectoris.
June 16th, 2011
FDA Says Pioglitazone Use Is Linked to Bladder Cancer
Larry Husten, PHD
The FDA has issued a safety announcement stating that the use of pioglitazone (Actos) for more than 1 year may be associated with increased risk for bladder cancer. The FDA announcement follows last week’s suspension of the drug in France and Germany by regulatory authorities in those countries.
The FDA said that pioglitazone should not be used in patients with active bladder cancer and should be used “with caution” in patients with a history of bladder cancer.
The FDA announcement was based on an ongoing safety review utilizing interim 5-year data from an ongoing epidemiological study. Although no overall increase in bladder cancer was found in the analysis, an increase in bladder cancer “was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.”
Compared with people who never used pioglitazone, those who were treated with the drug for more than 2 years had a hazard ratio for bladder cancer of 1.4 (95% CI, 1.03-2.0). The FDA calculated that among patients who used pioglitazone for more than 12 months, there would be 27.5 excess cases of bladder cancer per 100,000 person-years of follow-up (compared with patients who never used the drug).
The FDA also said it was “aware” of the French epidemiological study that sparked the European suspensions. The French study documented a significantly greater overall risk for bladder cancer among people who took pioglitazone than among those who took other diabetes drugs (HR, 1.22; 95% CI, 1.03-1.43), as well as a significantly elevated risk among people who used the drug for longer than 1 year (HR 1.34; 95% CI, 1.02-1.75).
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