March 11th, 2014
French Surgeons Perform First Totally Endoscopic Aortic Valve Replacement
Larry Husten, PHD
Surgeons in France report that they have performed the first totally endoscopic aortic valve replacement (TEAVR) in two human patients. Their paper has been published in the the Journal of Thoracic and Cardiovascular Surgery.
The new procedure may enable surgeons to replace the aortic valve without opening the chest, though it will still require cardiopulmonary bypass and resection of the old valve. The key to the new procedure is the recent availability of sutureless aortic valve bioprostheses, in this case the Medtronic 3f Enable bioprosthesis. In recent years these devices have allowed surgeons to develop “minimally invasive” surgical techniques. The new report is about the first surgical procedure in which the chest is not opened and the procedure is performed entirely through endoscopes. The authors point out that one advantage of TEAVR is that it is very easy to convert to a more traditional open surgical procedure if it becomes necessary.
The two patients were 82 and 93 years of age and had aortic valve stenosis. The patients spent about 2 and 1/2 hours under cardiopulmonary bypass, but the actual implantation of the device took only 45 minutes. Both patients were discharged from the hospital in a week and have had no serious complications.
The authors say that the procedure times were “acceptable” and that they believe the learning curve for TEAVR could be shorter than for totally endoscopic bypass surgery. They further anticipate that advances in technology will lead to more efficient procedures.
The lead author of the paper, Marco Vola, a cardiovascular surgeon in Saint-Etienne, France, discussed the development of the procedure in a press release issued by the journal: “In our institution, we began by adopting the mini-sternotomy technique, involving a small incision through the sternum, as routine. We then transitioned to the right mini-thoracotomy approach, involving a small incision through the thorax, first under direct view, then with an endoscopic camera. Finally we adopted a totally endoscopic technique.”
“These first procedures show that totally endoscopic sutureless aortic valve replacement is technically feasible,” he said. “Further clinical experience and technical development are necessary to shorten operation times and to assess further the potential postoperative benefits of TEAVR.”
Catherine Otto, the co-chair of the writing committee for the new ACC/AHA valve guidelines, offered the following perspective on this new procedure:
The first description of a totally endoscopic sutureless aortic valve replacement in 2 elderly patients is another exciting development in potential options for treatment of severe symptomatic aortic stenosis. Compared to a standard surgical approach, a median sternotomy is not required although patients still require general anesthesia and an aortotomy for placement of the valve. Compared to transcatheter aortic valve implantation (TAVI), the endoscopic approach allows removal of the native calcified valve which might, in theory, reduce long term embolic rates or paravalvular regurgitation — although we have no data yet addressing these issues. On the other hand, the endoscopic procedure is more invasive than TAVI with several chest wall incisions and the aortotomy. If larger studies show that this approach to aortic valve replacement is effective with an acceptable mortality and morbidity, it will offer an intermediate option between standard surgical aortic valve replacement and transcatheter aortic valve implantation.
March 11th, 2014
Cardiologist Tapped to Run the Smithsonian Institution
Larry Husten, PHD
A cardiologist has been chosen by the Smithsonian Institution’s Board of Regents to be the next leader of the Institution. David Skorton, who is currently the president of Cornell University, will be the Institution’s 13th Secretary, effective July 2015. He will be not only the first cardiologist but also the first physician to run the Smithsonian.
Before going to Cornell, Skorton had been the president of the University of Iowa from 2003 to 2006.
David Skorton
“David Skorton has demonstrated keen vision and skilled leadership as the president of two great American universities,” said the Chief Justice of the United States, John Roberts, Jr., who is also a board member of the Smithsonian. “His character, experience and talents are an ideal match for the Smithsonian’s broad and dynamic range of interests, endeavors and aspirations. I look forward to working with David to increase the impact of an incomparable American institution across the spectrum of arts, sciences, education, and culture.”
John McCarter, the chair of the Smithsonian Board, said that Skorton was chosen because he is a well-rounded, accomplished leader. “As a successful president of two universities, David has led complex organizations. He is an accomplished research scientist and a strong advocate for the arts and humanities, which make him an extraordinary fit for the Smithsonian.”
Skorton, who is 64, has been a successful fundraiser at both Cornell, where he raised more than $5 billion, and at the University of Iowa, where he raised more than $1 billion. He is also considered to be a strong supporter of industry–university partnerships.
As a cardiologist, Skorton’s research and clinical interests centered on congenital heart disease and applying computer analysis to cardiac imaging. Skorton was a co-editor, with his mentor Melvin Marcus, of Cardiac Imaging, a textbook that accompanied Braunwald’s Heart Disease, and became the editor of a later edition of the textbook when it became known as Marcus Cardiac Imaging.
On the Smithsonian Magazine website, Skorton answered a question about what attracted him to the Smithsonian job:
Number one, the fact that this is a fabulous interface with the public. On the mall, and across the country, and in the towns that have the affiliate museums, and around the world based on the Internet, it’s a way for them to almost palpably get their arms around these exhibits and this knowledge that’s here. And as a lifelong educator and physician, that interface of explaining things, learning things is really, really important to me. That’s one.
Number two, from a life in medicine, I’ve learned that the first thing a physician has to do—and I was a diagnostician, I’d like to think that I still am—is to be quiet and listen. Be quiet and observe. Be quiet and try to make sense of what I see. And this is a place that allows you to do that.
And I’m very passionate about trying to express that chance to do any sort of education, and you guys do a lot of it. Maybe more widespread than any entity I’ve ever worked with.
March 10th, 2014
Azithromycin, Levofloxacin Linked to Increased Risks for Arrhythmia and Mortality Compared with Amoxicillin
Nicholas Downing, MD
Azithromycin and levofloxacin carry higher arrhythmia and mortality risks than amoxicillin, according to an observational study in the Annals of Family Medicine. The FDA issued a cardiac warning on azithromycin in March 2013.
Researchers studied nearly 1.8 million U.S. veterans (mean age, 57) who received outpatient prescriptions for one of the three antibiotics from 1999 to 2012. During treatment, patients receiving azithromycin had roughly a 50% increased risk for death and an 80% increased risk for serious arrhythmia, compared with those on amoxicillin. Risk increases were even greater for levofloxacin.
The researchers conclude: “There are usually multiple antibiotic choices available for older patients, especially those with cardiac comorbidities; physicians may consider prescribing medications other than azithromycin and levofloxacin.”
March 10th, 2014
Generic Lipitor Recalled Again
Nicholas Downing, MD
Ranbaxy has recalled over 60,000 bottles of generic atorvastatin after a pharmacist found a 20-mg tablet in a sealed bottle labeled with the 10-mg dose. The FDA considers this a class II recall, indicating “a remote chance of severe adverse consequences or death due to the product flaw,” Reuters reports.
March 10th, 2014
Can Decision Support Tools Actually Harm Patients?
Christine Sinsky, MD
Christine Sinsky is an internal medicine physician in Dubuque, Iowa. This post originally appeared on her blog, Sinsky Healthcare Innovations, and has also been published on
Have you ever encountered an intrusive, insistent popup decision support screen while trying to take care of patients? Found yourself stuck in a dead end electronic hallway without egress? A situation where you had to choose an option that was inappropriate for your patient just to exit the screen?
This is the situation with my local medical institution’s “DVT Advisor,” a mandatory decision support screen for all patients.
DVT Advisor was implemented in response to meaningful use and out of a laudable desire to improve safety. Unfortunately, as constructed, the Advisor has the opposite effect. In this popup the physician must process through a 5 screen, 9 click process. The first step identifies the patient’s DVT risk level. If the risk level is low, no intervention is required. Yet, inexplicably, the physician must next process through the 4 additional screens to record whether the patient has any contraindications to the interventions which the Advisor has just indicated are not recommended. (!)
I’ve learned how to click through each of these cluttered, non-intuitive screens to get on to the business of taking care of patients, but it is a distraction, and thus hazardous.
I recently had a patient the DVT advisor identified as “high risk.” I was sending him home that day, so no anticoagulation was necessary. Nonetheless I had to wade through each screen, documenting that the patient didn’t have any contraindications to a treatment I wasn’t planning to give. At the end there was a force field where the only option was to choose one of 4 anticoagulant regimens. I could find no other option. There was a button elsewhere on the screen where I could decline the intervention, but doing so simply resulted in the popup reappearing the next time I entered an order, and I had to go back and progress through all 5 screens from the beginning and ultimately choose an anticoagulant for the patient in order to continue writing orders, or finish all of the other orders and then exit when there would be no further orders to trigger the popup yet again. No other way to get around it. No way to be the human being in the equation who had sense and could say this patient doesn’t need this intervention.
One of my colleagues told me that in these (common) situations he selects one of the anticoagulant options, which creates an order for his patient for a medication that is not indicated, and then he goes back in the medication list a few minutes later and discontinues it. Talk about waste. Talk about hazard.
The information in the DVT Advisor can be a useful reference if a physician is uncertain about anticoagulation, but its intrusive and insistent characteristics are based on hope and belief, rather than evidence. The mandatory requirement to prescribe anticoagulation, even when the physician has reasons not to prescribe it, has gone far too far in my view, and has created a systematic occasion for patient harm.
Time spent on such low-value exercises or workarounds is time taken away from other patient care. What 5 minutes of talking with the patient, a colleague or consulting a medical resource, what 5 minutes of deep medical decision making shall I give up in order to move through this poorly constructed, time-consuming low-value work?
The hospital is a large organization, and has heard from many physicians about the form, but still the rigid and mandatory popup persists. Individual physicians do not have control over its design and yet labor under its impact. This is part of the real life harm associated with products that could in theory be helpful. The form was designed in response to the current federal regulatory climate, citing meaningful use and a move to more clinical decision support. The resultant hazard to patient safety may be an unintended consequence of over-reaching regulation but it is a real side effect nonetheless.
Addendum: A week later I had a 91-year-old patient identified as high risk who was already on coumadin. The DVT Advisor would not allow me to exit without ordering enoxaparin or unfractionated heparin. I could find no other way to deal with this except as my colleagues have also done: order the enoxaparin, wait a few minutes for the order to be processed, and then remember to go back in and cancel the order.
March 10th, 2014
Selections from Richard Lehman’s Literature Review: March 10th
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.
JAMA Intern Med Mar 2014
Cognitive Function and Brain Structure in Persons With Type 2 Diabetes Mellitus After Intensive Lowering of BP and Lipid Levels (pg. 324): There was a deathly silence when the NEJM first published the results of the ACCORD trial in June 2008. Nearly six years on, the diabetes community is still coming to terms with the demolition of its conceptual edifice based on ever tighter control of glucose and blood pressure. In the 40 months of the trial, we learn from this paper, people with longstanding diabetes in the tight BP control group showed more brain shrinkage on MRI than those on a laxer regimen. Cognitive function was the same in both groups. But these are just the sort of short-term data it’s best to ignore: we need much more than this to draw conclusions about specific treatments for type 2 diabetes. For more on that topic, read the excellent viewpoint by Kasia Lipska and Harlan Krumholz—Comparing Diabetes Medications: Where Do We Set the Bar?
Association of β-Blocker Therapy With Risks of Adverse Cardiovascular Events and Deaths in Patients With Ischemic Heart Disease Undergoing Noncardiac Surgery (pg. 336): One area of controversy I haven’t much commented on is the prescription of beta-blocking drugs prior to non-cardiac surgery. Mere GPs play little part in this saga, but out there in the exciting world of European cardiologists and surgeons, it’s been hotly debated, with accusations of needless deaths, bad trials, and non-evidence-based guidelines. To this fray, the Danes have now added some very useful observational evidence from their wonderful national registry. It seems that pre-op β-blockers only improve outcomes for two kinds of patients: those with heart failure and those who have had a recent myocardial infarction; i.e. those who should be on them anyway.
Warfarin Interactions With Antibiotics in the Ambulatory Care Setting (pg. 409): One of the commonest situations of risk for a drug interaction is the prescribing of antibiotics to patients on warfarin. I do it all the time, usually advising patients to reduce their warfarin dose slightly for the duration. A study from Kaiser Permanente shows that even this token effort is probably little needed. The investigators looked at over 11,000 patients with acute respiratory infections who were taking warfarin and who were or were not given antibiotics. “The proportion of patients experiencing an INR of 5.0 or more was 3.2%, 2.6%, and 1.2% for the antibiotic, sick, and stable groups, respectively…. Acute upper respiratory tract infection increases the risk of excessive anticoagulation independent of antibiotic use. Antibiotics also increase the risk; however, most patients with previously stable warfarin therapy will not experience clinically relevant increases in INR following antibiotic exposure or acute upper respiratory tract infection.”
JAMA 5 Mar 2014 Vol 311
Warfarin, Kidney Dysfunction, and Outcomes Following Acute Myocardial Infarction in Patients With Atrial Fibrillation (pg. 919): A Swedish registry study looks at what happened to people (median age 79) admitted to hospital with myocardial infarction who were discharged with atrial fibrillation. Only 22% of them went home on warfarin. The investigators were particularly interested to see if their kidney function seemed to make any difference to outcomes. It did not: “Warfarin treatment was associated with a lower 1-year risk for the composite outcome of death, MI, and ischemic stroke without a higher risk of bleeding in consecutive acute MI patients with atrial fibrillation. This association was not related to the severity of concurrent CKD.”
BMJ 8 Mar 2014 Vol 348
Removing the Hype from Hypertension: A splendid editorial has just appeared on the BMJ website dealing with the astonishing disparity between the early open trials of the Medtronic Symplicity renal denervation device, and the subsequent properly conducted randomized Symplicity 3 trial. You’ll remember that I was hoodwinked by the hype which surrounded the publication of the long-term follow up of the original Symplicity 1/2 trial in the Lancet three weeks ago, showing a 30mm Hg drop in systolic BP maintained into the third year. The Symplicity 3 trial of the same device subsequently failed to meet its prestated end-point of a 10mm Hg drop. This should already have been known to the Lancet, as it had been announced by Medtronic on the 9th January. It’s a startling illustration of the need for randomized, properly blinded trials of medical devices. And it’s scary to think how few of those there have been—of devices currently used by millions of people.
March 6th, 2014
Vena Cava Filters Reduce Pulmonary Emboli But Increase VTE Recurrence Tenfold
Inferior vena cava filters seem to offer protection against death from pulmonary embolism when compared with anticoagulant therapy, but they have no significant effect on all-cause mortality. In addition, the filters are associated with higher rates of recurrent venous thromboembolism, according to an article in the Journal of the American College of Cardiology.
Researchers examined data from some 40,000 patients with VTE, 344 of whom received filters because of their increased risks for bleeding (they could also receive anticoagulants). The filter recipients were matched with 344 controls on anticoagulants only.
By 30 days, the all-cause mortality rate (the primary endpoint) did not differ between the groups. A secondary endpoint, death from pulmonary embolism, favored the filter group over the controls (1.7% vs. 4.9%). However, the rate of recurrent VTE was tenfold higher among filter recipients (6.1% vs. 0.6%).
An editorialist writes that the finding on pulmonary embolism deaths “suggests that filters offer clinical benefits that are discrete from those conferred by anticoagulation.”
March 5th, 2014
4 Deaths Linked to Thoratec HeartMate II LVAS
Larry Husten, PHD
Thoratec Corporation on Tuesday issued an urgent safety advisory about a serious problem with a key component of the HeartMate II LVAS system. The company said four patients had died and five had a loss of consciousness or other symptoms of hypoperfusion. The episodes occurred when patients and caregivers “experienced difficulties with the process of changing from a primary system controller to their backup system controller.”
The company said that eight of the nine events “occurred in patients who were converted to the Pocket Controller after being originally trained on an older model, the EPC System Controller. Two of the deaths occurred in patients who attempted to exchange system controllers while alone and, contrary to the labeling, without contacting the hospital first.”
Thoractec said that their investigation did not uncover any device failures. Patients with the Pocket Controller “should immediately contact their doctor for retraining on use of the device” and receive an updated patient handbook.
The advisory applies to all HeartMate II LVAS Pocket Controllers, which have been available in Europe since August 2012 and the U.S. and Canada since May 2013. The company said that 2142 Pocket Controllers have been prescribed, either as original equipment with the HeartMate II LVAD or as a replacement for an older controller. Patients who updated from an older controller are at higher risk for complications because they “may not have received adequate training regarding the differences between the two controllers, especially differences related to the connection of the driveline.”
In November 2013, an article published online in the New England Journal of Medicine reported a highly troubling increase in pump thrombosis in patients who received the HeartMate II device.
March 4th, 2014
AF Patients with Chronic Kidney Disease Also Benefit from Warfarin
Larry Husten, PHD
Anticoagulation is a cornerstone of therapy for atrial fibrillation because it lowers the heightened risk for stroke in this population. People with chronic kidney disease are also at increased risk for stroke, but the benefits of anticoagulation are less clear in this group, and anticoagulation is used less often in AF patients who have CKD. Now, a large observational study offers some reassurance that anticoagulation in AF patients with CKD may be beneficial.
Researchers in Sweden analyzed data from more than 24,000 survivors of acute myocardial infarction who had AF. In a paper published in JAMA, they report that more than half (51.7%) of this group had CKD (stage 3 or above). More than a fifth (21.8%) of all patients were treated with warfarin, and after 1 year of follow-up, these patients had a lower rate of death, MI, or stroke but no significant increases in bleeding complications. The findings persisted after the researchers adjusted for differences between the groups. Severity of CKD did not affect the results.
In an accompanying editorial, Wolfgang Winkelmayer and Mintu Turakhia discuss some of the limitations of the study, including “the central issue of confounding by indication for warfarin treatment.” They also point out that INR control in Sweden is the best in the world, so the results of the study may not apply where warfarin is not optimally employed. In addition, they caution that the results should not be generalized to AF patients who have not had an MI.
Nevertheless, they write, the study “provides the best evidence to date that vitamin K antagonists are associated with improved clinical outcomes and no significant increased risk of bleeding in patients with myocardial infarction and atrial fibrillation with advanced CKD. These data support the use and continuation of warfarin therapy among patients with CKD with excellent INR control.”
March 3rd, 2014
A New Approach for the Statin-Intolerant Patient?
Andrew M. Kates, MD
We are all well familiar with the patient who reports muscle symptoms with statins. But just how should we deal with this? How do we know that symptoms are due to the statin rather than some other factor? The reported incidence of myalgia in clinical trials has been criticized on many fronts as inaccurate, underestimating the “real world” experience.
Clearly, one of the challenges is determining whether a patient’s symptoms are attributable to statin or some other cause. To assess this, a unique study design — an “n-of-1 trial” — has been purported as an effective way to limit biases in individual patients as each patient serves as his or her own control. N-of-1 trials are single-patient, randomized, multiple crossover, blinded comparisons of an active treatment versus placebo.
In a study published today in the Annals of Internal Medicine, researchers at Western University in London, Ontario conducted a proof-of-concept study to assess the feasibility and potential value of n-of-1 trials in patients with statin-related myalgia.
Eight patients who had discontinued statin use due to myalgia were randomly assigned to statin therapy or placebo, up to three times each, for up to three weeks. Treatment periods were separated by three-week washout intervals to minimize carryover effects. Seven patients completed the entire trial (three treatment pairs), and one completed two treatment pairs. For each n-of-1 trial, there was no clinically significant difference in myalgia or other pain measures. Five patients resumed open-label statin treatment at the end of the trial.
The authors suggested that this type of trial is a potentially useful tool to examine myalgia caused by statin use in selected patients.
What do you think of this type of trial design?
How do you approach the statin intolerant patient now?
Would the n-of-1 approach be successful in your practice?
NEJM Journal Watch — Recent Cardiology Articles- Major and Intracranial Hemorrhage Risk with Direct Oral Anticoagulants vs. Aspirin
- Chlorthalidone vs. Hydrochlorothiazide for Hypertension: Renal Outcomes
- Estimating Heart Failure Risk in the U.S. Population with the PREVENT Calculator
- Atrial Fibrillation and Stable Coronary Artery Disease — What Is the Optimal Anticoagulation–Antiplatelet Regimen?
- β-Blockers After Myocardial Infarction