July 10th, 2014
Behind the Patient Decision-Making Process for a Destination-Therapy LVAD
Colleen Kelley McIlvennan, DNP, ANP, Larry Allen, MD, MHS and Dan Matlock, MD, MPH
CardioExchange’s John Ryan interviews Colleen K. McIlvennan, Larry A. Allen, and Daniel D. Matlock about their study on how patients choose whether to get a left ventricular assist device (LVAD) as destination therapy. The study is published in Circulation: Cardiovascular Quality and Outcomes.
THE STUDY
From October 2012 to September 2013, researchers interviewed 15 patients who opted for a destination-therapy LVAD and 7 who had declined the therapy. Accepters of the therapy either made the choice automatically (11 patients) or after substantial reflection (3 patients); all 7 decliners were reflective in their approach to decision making. (One patient’s approach did not clearly fit into either category, largely because of his inability to focus during the interview.) The automatic group was characterized by a fear of dying and an overriding desire to live as long as possible, whereas the reflective group went through a reasoned process of weighing risks, benefits, and burdens. Regardless of the approach, most patients experienced the decision as a highly emotional process, and many sought family and/or spiritual support.
THE INTERVIEW
Ryan: Briefly explain what drew you to do the study.
McIlvennan, Allen, and Matlock: With medicine’s expanding array of life-prolonging technologies, older people with chronic illness are increasingly offered invasive interventions. As clinicians who spend an increasing amount of time and energy in the field of mechanical circulator support, we feel that the destination-therapy LVAD is a prime example of how advances have created challenging decisions with complex tradeoffs. Typically, patients are faced with a decision either to undergo a major operation (with significant lifestyle changes) for a chance at prolonging life or to forgo therapy and live their remaining days under palliative or hospice care. The difficulty of this situation is amplified by the extension of LVAD destination therapy into an increasingly older population with multiple comorbidities.
The prevailing approach to patient decision support has been a combination of impersonal consent forms, overly positive industry marketing materials, and education about the particulars of the device. What we have seen at the individual patient level is a high-degree of emotion, confusion, and unrealistic expectations.
We found a scarcity of literature on how people make decisions about LVAD destination therapy — or any life-threatening medical decision. Therefore, we aimed to explore the decision-making process of patients who are considering this life-prolonging therapy, in order to inform future development of decision support tools.
Ryan: The paper is quite interesting. What surprised you most about your findings?
McIlvennan, Allen, and Matlock: Our findings show that some patients offered an LVAD as destination therapy cognitively assess the situation and reason the through risks and benefits (a “reflective” decision). For others, the desire to live supersedes such reflective processing, and the decision is largely intuitive (an “automatic” decision). The study shows that for many people, particularly those with an automatic response, major interventions designed to delay impending death appeal directly to their primal desire for self-preservation and may alleviate their fear of death. This desire is so strong that it effectively suppresses other considerations; many patients do not necessarily wish to know about side effects and burdens — or even the extent to which the destination-therapy LVAD actually prolongs life.
This finding is discordant with the current paradigm for informed consent, which assumes that patients will be extremely cognitive in their approach, largely ignoring the importance of human emotions and behaviors. Although information is essential for informed consent and is helpful to some patients, our results show that cognitive weighing of theoretical risks and benefits played a secondary role in the decision-making process for many patients.
Ryan: I was intrigued by the lack of a difference in decision regret between the automatic and reflective groups, even though the automatic group appeared to have more complications. Do you think this was related to the active role the patients played in the decision making.
McIlvennan, Allen, and Matlock: The fact that we saw no difference in decision regret is probably attributable the study’s lack of statistical power to test the difference. Other literature shows that patients who have a more active role in decision making have less regret. Unfortunately, we are unable to make any conclusions about regret, given our small sample size.
Ryan: One of the “accepters” said, “’God, you’re in charge. Do what you do.’ So they decided to put an LVAD in me.” Of secondary influences like this one, which were the most influential in determining whether people were accepters or decliners?
McIlvennan, Allen, and Matlock: Overwhelmingly, the choice whether to accept a destination-therapy LVAD was largely explained by a patient’s decision process (either automatic or reflective); however, many patients said that they considered other factors. Spirituality and religious beliefs were frequently discussed across both automatic and reflective decision types. Relationships with family and friends were the most commonly cited influences. Many patients sought guidance from a spouse, a close friend, or God. Interestingly, many of the decliners (all in the “reflective” group) said they were “not afraid of death.” This statement was not just spiritual, but seemed to reflect some inner reconciliation of an innate existential angst.
JOIN THE DISCUSSION
Share your reflections on how patients go about choosing or declining a destination-therapy LVAD.
July 10th, 2014
Should Doctors Be Paid Overtime for Taking Call?
David Mann, MD
Taking call is the worst thing about being a doctor. There. I said it. But wait! What about medical malpractice lawsuits? What about dealing with patients’ suffering or dying either from their illness, or far worse, relating to decisions you made or procedures you performed? Certainly these are far worse events than being on call?
Granted. However, these awful events are part of the battle that we signed up for when we made the decision to become doctors. The soldier goes into battle with the attitude that he or she will do everything possible to avoid getting shot or killed, while at the same time realizing these are distinct possibilities. So too doctors leap into the fray with a positive attitude, while similarly realizing that, inevitably, there will one day occur a bad outcome with its attendant soul-crushing consequences. These bad outcome events, similar to earthquakes, occur randomly (stochastically is the term the geologists use). If you live in California you usually don’t spend every waking minute of your day worrying about “the Big One.” So too doctors don’t spend all their time worrying about bad outcomes.
I did however spend an inordinate amount of my time worrying about being on call when I was a practicing cardiologist working for a hospital-owned healthcare system. My life was divided into two phases. Phase one occurred between call nights and was spent worrying about the next call night that was coming up. Phase two occurred when actually on call, and was worse than phase one. The only saving grace of being in phase two was that phase one was coming up soon, which was a relief. In fact, the day after call (especially after a weekend on call) I always had a sense of relative euphoria because call was over, at least until the next time.
What made call miserable? There were many elements. There were the routine calls to reconcile medication orders for newly admitted patients. Mind-numbing but easy. There were calls for clarification of orders that were already perfectly clear. There were the dreaded calls to the Emergency Room, almost always implying a new admission. There were pages for new consults, sometimes with the words “see today” appended, even though it was the middle of the night, and after talking with the nurse I still hadn’t a clue why the consult was deemed urgent. There were the routine admissions for chest pain in the middle of the night for which I would give garbled, sleepy orders, which a helpful nurse would translate into reality, at least until it was required that we enter these orders into our EPIC EHR (electronic horrible record) system directly, removing that last human barrier between sleep-deprived confusion and the patient. Finally there always seemed to be at least one “problem” patient, who was doing worse and worse despite multiple phone orders, resulting in an inevitable visit to the hospital at 3 in the morning.
My practice provided coverage to all the hospitals in Louisville, split between 2 and then 3 doctors on call (the coverage scheme kept evolving as our healthcare group absorbed more and more practices into its fold). Also covering were the cardiac interventionalists, whose on-call night had fewer phone calls, but unfortunately each call proved significant in that it usually led to a rapid trip to the hospital to perform a coronary intervention on a deathly ill patient suffering an acute myocardial infarction (heart attack). My call nights in contrast were characterized by many phone calls (anywhere from 20 to 40 per night) punctuated by occasional trips into the hospital. Although I tried to sleep when I could, I was only intermittently successful, and the sleep achieved was a mixture of sleep phases never intended by nature.
As time went on call got worse. With more practices absorbed, more doctors were added to the call pool, but the number of patients covered also increased. The net result was that the call frequency (about one weeknight a week, and one weekend every 3 or 4 weeks) never really decreased, though the amount of calls that needed to be handled did. So with time the dread of being on call only worsened.
Perhaps it is not widely known that doctors are not paid to be on call. This stems from the masochistic, self-flagellant nature of medicine that is our tradition. In fact if one looks across the generations of physicians, the older generation always looks down on the younger generation of doctors, feeling they have it too easy, saying things like, “if you think you have it bad, when I was training I was on call every other night,” and so forth. In fact just looking at my generation, I recall that at Methodist Hospital in Houston, where I was a cardiology fellow in the early 1980s, the surgical resident in the post-cardiac surgical ICD (this was during the heyday of Michael DeBakey) was on call for 2 months straight! He never left the unit for 2 months. They sent a barber in to cut his hair. I remember seeing him shuffling around the unit from time to time at all hours, looking like a zombie. But I’m sure his elders thought he had it easy (“in my day, we were on call for 6 months straight”). Nowadays house staff associations have brought about reforms, so that actually on call for today’s house staff is easier — uh oh, there I go, proving my point.
Anyway, doctors don’t get paid overtime, or any additional time for being on call. Oh sure doctors make good salaries, and it’s always said that somehow being on call is factored into their salaries. Right. Try that with nurses, cath lab technicians, even your local plumber and see how far it gets you. But doctors do tend to just suck it up and take call, because they have a duty to their patients and there does not seem to be any other system to cover a medical practice 24/7.
But I did hate being on call more than anything, and I am happy to be free of that responsibility. My only advice to my still-working colleagues is that, when the hospital systems that own you start cutting your pay, point out to them all the back hours of overtime they still owe you.
July 8th, 2014
TAVI Explored to Treat Aortic Bioprosthesis Failure
Larry Husten, PHD
With the increasing use of bioprosthetic aortic valves in aortic valve replacement surgery, more and more physicians and patients will inevitably be faced with the dilemma of how best to treat degenerated valves. Although surgical reoperation is considered the best solution, many patients are too old and frail for surgery. Transcatheter aortic valve implantation (TAVI) has been proposed for use in this situation, though the risks and benefits have not as yet been well defined.
Now, a new study in JAMA provides information on 459 patients with failed bioprosthetic valves who underwent TAVI. The investigators in the VIVID (Valve-in-Valve International Data) Registry report that the death rate was 7.6% at one month and 16.8% at one year. A total of 39.5% of valve failures were due to stenosis, 30.3% due to regurgitation, and 30.3% due to a combination of the two. Survival was lowest in the stenosis group and in patients with small valves compared with patients with intermediate-size or large valves.
David Hillis offered an insightful perspective on this paper:
Inevitably, some recipients of bioprosthetic valves experience prosthetic valve failure and need some form of re-do procedure. A repeat surgical AVR carries a substantial risk, since (1) these patients are often quite elderly, and (2) any re-operation potentially can be high-risk (any time one cuts into a chest that has been cut on previously, surprises sometimes await — i.e., stuff is stuck to other stuff that makes the procedure complicated and difficult). Bioprosthetic valve failure is not common — but it does occur, particularly with prostheses that have been in place for >10-12 years. Having a nonsurgical alternative to repeat AVR is attractive. This registry experience simply concludes that performing TAVI in these individuals is a reasonable alternative. Is it better than repeat surgical AVR? Obviously, this paper doesn’t answer that question.
In short, I would term this a “feasibility study” — doing TAVR on these subjects is feasible.”
July 8th, 2014
USPSTF Finalizes Recommendations on Carotid Artery Stenosis Screening
Nicholas Downing, MD
The U.S. Preventive Services Task Force has recommended against screening for asymptomatic carotid artery stenosis in the general adult population (grade D recommendation). Published in the Annals of Internal Medicine, the statement reiterates the group’s 2007 guidance.
The harms of screening outweigh the benefits, the task force says. The groups notes that all screening strategies (e.g., ultrasonography, magnetic resonance angiography) “have imperfect sensitivity and could lead to unnecessary surgery and result in serious harms, including death, stroke, and myocardial infarction.”
The recommendation applies to adults without histories of transient ischemic attack, stroke, or other neurologic symptoms.
July 7th, 2014
Statins Are a Mess: We Need Better Data, and Shared Decision Making
Ben Goldacre, MB, BS, BA, MA, MBBS, MSc
The following open letter was originally published on The British Medical Journal‘s editorial page regarding the adverse effects of statins for patients with low risk of cardiovascular disease. It was written in response to an analysis by Abramson et al, and more information on the subject can be found
I have two observations to make on the statin wars.
Firstly: if there is any uncertainty at all about the risks and benefits of statins – and there is – then we have failed to competently implement the most basic principles of evidence based medicine. Statins are the single most commonly prescribed class of treatment in the developed world, taken by tens if not hundreds of millions of patients every day. That would be more than enough clinical experience to resolve any research questions, if we were competently identifying all outstanding uncertainties, and conducting well-designed trials to answer those questions in routine clinical care (see related article here). We need better data; better dissemination of that data; and better communication of that data, in ways that help people make decisions which reflect their wishes. Statins should be the crowning glory of evidence-based medicine, our perfection incarnate: instead, they are a mess.
Secondly: while disputes over individual numbers are important, the leading protagonists in the statin wars seem, above all, to be suffering under a grand delusion that all patients think like they do. On the one hand, we have clinicians and researchers insisting that no sane patient would refuse a safe simple treatment that reduces their chances of a heart attack by one in 200; on the other, we have clinicians and researchers insisting that one in 200 is a laughable and trivial benefit, which no sensible patient could ever care about.
In reality, all patients are different, and we all – as doctors or as patients – weigh up different factors differently. Some want longevity at any cost; some think taking a pill every day is an affront to their independence. Some think aching muscles are a trivial niggle; some think that side effects – even when mild, well-documented, and carefully discussed – are proof that their doctor is a reckless idiot.
When we offer statins, or any preventive treatment, we are practicing a new kind of medicine, very different to the doctor treating a head injury in A&E. We are less like doctors, and more like a life insurance sales team: offering occasional benefits, many years from now, in exchange for small ongoing costs. Patients differ in what they want to pay now, in side effects or inconvenience, and how much they care about abstract future benefits. Crucially, the benefits and disadvantages are so closely balanced that these individual differences really matter.
Because of that, this new kind of medicine needs perfect information. We need clean, clear data showing the risks and benefits of preventive treatments, on real world outcomes, beyond any reasonable doubt, at every level of risk, and for as many subgroups as possible. We need shared decision making products that are universally available, carefully validated, and seamlessly integrated into routine clinical care, to help all patients make their own truly informed decisions. Lastly, we need to recognise that different patients have different priorities: different to each other and, sometimes, very different to our own.
July 7th, 2014
Selections from Richard Lehman’s Literature Review: July 7th
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 3 July 2014 Vol 371
Loss-of-Function Mutations in APOC3 and Ischemic Vascular Disease, Triglycerides, and Coronary Disease (pg. 22, 32): My heart sank last week when two papers appeared on the NEJM website with the titles Loss-of-Function Mutations in APOC3, Triglycerides, and Coronary Disease, and Loss-of-Function Mutations in APOC3 and Risk of Ischemic Vascular Disease. I resolved to ignore them. However, Harlan Krumholz ‘s comments on them really have to be read: “This research”, he said, “has absolutely no implications for clinical practice. It might one day be seen as a pivotal study that led to the development of remarkable drugs, but that is far away. I hope people don’t read it and think that it has relevance to their current decisions about treatment.”
JAMA Intern Med July 2014
Effect of Patients’ Risks and Preferences on Health Gains With Plasma Glucose Level Lowering in Type 2 Diabetes Mellitus: Four years ago, John Yudkin drew my attention to a study that had just appeared in the Archives of Internal Medicine, illustrating a new and radically patient centred kind of modelling for “utility versus disultility” in long term treatment. It appeared under the banner of “LESS IS MORE” and bore the title: “Variation in the Net Benefit of Aggressive Cardiovascular Risk Factor Control Across the US Population of Patients With Diabetes Mellitus.” It should have shaken the world but, as so often in this field, it was politely ignored because it ran counter to the standard model of practice. John had heard that the Michigan authors had another paper up their sleeve, dealing with the individual utilities or disutilities of varying degrees of glucose control in the same population. We grew so eager to see this published, that John went over to recruit Harlan K at Yale to join forces in urging Rod Hayward to complete work on it. I joined the trip and my life was changed, but the study has only now been published.
Everybody should read it. “Treating patients with HbA1c levels less than 9% should be individualized on the basis of estimates of benefit weighed against the patient’s views of the burdens of treatment.” Do you dare to have this discussion with your patients with longstanding type 2 diabetes mellitus? Or with any other patient you have “put on” long term treatment? “We estimate that the expected gain in QALYs for a 1-point change in HbA1c level in a 75-year-old is 0.06 years (22 days), even with the favorable assumption that glycemic control’s cardiovascular benefit extends to the elderly.” Now go back to their original paper and think hypertension.
The BMJ 5 July 2014 Vol 349
Revascularization vs. Medical Treatment in Patients with Stable CAD: Network meta-analyses are a mixed blessing. Experts argue that by using a bayesian random effects Poisson regression model, you can preserve randomised treatment comparisons within trials. But that begs the question of how you can achieve dependable comparisons between trials, robust enough to guide clinical practice. Unfortunately I was born with loss of function variants on my STATS-WONK alleles and cannot work that out. This network meta-analysis would have us believe that the era of COURAGE has come to an end: thanks to better drug eluting stents and techniques for coronary artery bypass surgery, people with stable coronary artery disease will now experience fewer deaths and myocardial infarctions if they have early invasive treatment. But I couldn’t dig out the figures that would allow me to share any decisions confidently with actual patients. I fear that this meta-analysis, which is very hard to confirm or contest, will simply be used as a pretext for interventionists to return en masse to their bad old habits.
July 3rd, 2014
Retraction Dissolves Credibility of Acid-Bath-Generated Stem Cells
Sadly, what seemed too good to be true now is: subjecting adult cells to an acid bath does not transform them into pluripotent stem cells, and the Nature papers reporting the effect have been retracted.
After initial excitement over the findings in January, a number of laboratories reported having trouble duplicating the results. Then in April, the RIKEN Center (where lead author Haruko Obokata did much of the work) conducted an investigation and accused her of “an act of research misconduct involving fabrication.”
A Nature editorial points out that after findings of manipulated photographs and plagiarized text, the papers’ co-authors concluded that they could not stand behind the results.
The editorial concludes with a plea for better behavior across the research enterprise, “to ensure that the money entrusted by governments is not squandered, and that citizens’ trust in science is not betrayed.”
July 3rd, 2014
Sitagliptin Associated with Increase in Heart Failure Hospitalizations
Larry Husten, PHD
The cardiovascular effects of drugs used for glucose control in patients with diabetes have been a subject of controversy for many years now. More recently, attention has started to focus specifically on the risk for heart failure (HF). Now, an observational study will likely raise new questions about the dipeptidyl peptidase (DPP)-4 inhibitor sitagliptin (Januvia, Merck).
In a paper published in JACC Heart Failure, Daniala Weir and colleagues analyzed insurance claims from a database of more than 7600 patients with diabetes and HF. People who took sitagliptin were not more likely than nonusers to have a primary endpoint event (death or all-cause hospitalization). However, they were more likely to be hospitalized for HF (12.5% vs. 9.0%, adjusted OR: 1.84, CI 1.16-2.92).
The authors said their finding “is likely clinically relevant” and might have an impact on the choice of add-on therapy for HF patients with diabetes.
In an accompanying editorial, Deepak Bhatt writes that the findings “add to a small but growing body of evidence that suggests DPP-4 inhibitors as a class of drugs, and possibly diabetes drugs in general, may increase the risk of heart failure.” However, he noted, the “increase in absolute risk, if present at all, appears to be small.”
June 30th, 2014
Registry Study Offers Reassurance About Newer Drug-Eluting Stents
Larry Husten, PHD
Findings from a large ongoing registry study provide some reassurance about the long-term safety of new-generation drug-eluting stents (DES) in patients with STEMI who undergo primary PCI. The results are published online in the Journal of the American College of Cardiology.
SCAAR (Swedish Coronary Angiography and Angioplasty Registry) investigators analyzed data from 34,000 primary PCI patients who received a bare-metal stent (BMS), an old-generation DES, or a new-generation DES. They found that in the first year after PCI, both new- and old-generation DES patients had a lower risk of stent thrombosis (ST) than did BMS patients. Very late ST up to three years was higher in the old-generation DES group compared to both the new-generation DES and BMS groups, which had similar risks. At one year the ST rate was 1.5% for BMS, 1.1% for the old-generation DES, and 0.9% for the new-generation DES. At three years the rates were 2%, 2.1%, and 1.3%.
ST has been the main source of concern about DES. The new findings lend support to the widespread view that the new-generation DES would reduce the late risk of ST that has been previously observed with old-generation DES.
Precise information about ST has been difficult to obtain from randomized studies, most likely because the studies have been underpowered to detect these sort of differences in the rate of rare but clinically important events.
In an accompanying editorial, Bradley Strauss and Mony Shuvy write that the “results are reassuring and should mitigate concerns about late and very late ST with second-generation DES in STEMI patients.”
Commenting on the papers, L. David Hillis said that “the registry’s size is impressive and it appears that both the authors and the editorialists have discussed the main limitations with these data: (1) the possible selection bias that may enter into any nonrandomized trial and (2) the lack of any information about long-term medical therapy, most importantly dual antiplatelet therapy.”
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