March 28th, 2012
A Great Take-Away Message
Jeremiah Depta, MD
Several Cardiology Fellows who are attending ACC.12 this week are blogging together on CardioExchange. The Fellows include Tariq Ahmad, Bill Cornwell, Megan Coylewright, Jeremiah Depta, and John Ryan (moderator). Read the previous post here.
The 2012 ACC meeting has come to a close. For me, the experience was amazing. The opportunity to learn and interact with friends, co-fellows, junior faculty, and experts in our field was priceless.
Yesterday, I attended the 11th Annual Maseri-Florio International Lecture. The session was chaired by Dr. Gregg Stone, who introduced Dr. Antonio Colombo as the invited lecturer. As a future interventionalist, I was incredibly excited to hear Dr. Colombo, as I have been an avid reader of his research, review articles, and chapters. I was amazed at the number of leaders in cardiology who attended the session.
Hearing Dr. Colombo speak about coronary intervention was enlightening. He started the lecture by showing his first PCI. For someone who has influenced the lives of millions of patients, it was remarkable that he chose to speak about his first experience placing a stent. He then went on to describe his first stent thrombosis, which I believe he said occurred during his third case. At this point, his words echoed an ethereal message. He described how he could not understand why this patient had a stent thrombosis. To paraphrase him, he stated that he could have blamed it on a stroke of bad luck, but that this way of thinking was incorrect. He said you should never accept a bad outcome as a stroke of bad luck. The outliers (i.e. bad outcomes) are the cases where we can learn the most and are an opportunity to advance the field of intervention.
From his experience with his first stent thrombosis, he came up with the idea that in order to prevent stent thrombosis you needed to have appropriate anticoagulation and platelet inhibition, excellent distal blood flow, and an appropriate lumen size post-stenting. These concepts spurred him initially to used dual antiplatelet therapy with aspirin and ticlopidine, when few people were using dual antiplatelet therapy. Dr. Stone recounted being sent to visit him to understand what “this guy” was doing over in Italy. He recalled that he discounted Dr. Colombo’s approach to antiplatelet therapy but admitted that he was obviously correct given the landslide of evidence proving Colombo’s theory. As an innovator, Dr. Colombo has shaped the way in which interventional cardiologists treat simple and complex coronary disease. Adhering to his theories, he helped to pioneer the use of intravascular ultrasound to optimize PCI. He also has revolutionized how we treat complex bifurcation lesions. It was quite an experience to see him philosophize about his approach to patient care, research, and life.
Walking away from his lecture, I took my single most important message from the 2012 ACC — to understand the outliers and to never equate a bad outcome as a stroke of bad luck. Throughout my training, I can recount numerous patients where I didn’t take the steps to understand what went wrong and how it can be fixed. His message of trying to understand the unexplainable is a message that I will carry throughout the remaidner of my career.
It is amazing to me that you can learn so much from just a few words…
March 27th, 2012
What to Do When Federal Investigators Knock on the Door
Larry Husten, PHD
For more than a year, the federal investigation of hospitals suspected of improperly implanting ICDs has been the subject of considerable rumor and speculation. Now, two cardiologists who were involved in a federal audit at one hospital have published a detailed account of their experience.
Jonathan Steinberg and Suneet Mittal are Columbia University-affiliated electrophysiologists who also direct the EP program at a large suburban nonteaching hospital. In a special article published in the Journal of the American College of Cardiology, the two authors describe the audit process and subsequent events in the hope that their experience “might provide valuable lessons” to others involved in similar cases.
The initial government analysis had found that 229 cases, representing 8.7% of all de novo ICD implants for primary prevention between 2003 and 2010, did not warrant coverage. Following a more detailed review of the medical records, the authors report that a much smaller number of cases, 34, representing 1.3% of all implants, were truly not indicated. These cases mostly occurred after bypass surgery in the setting of nonsustained VT and/or a positive EP study, according to the authors. By contrast, a small number of cases had a clear secondary-prevention indication, but the records for the earlier cardiac arrest or VT event were at another hospital.
Most of the cases were somewhat more ambiguous. Steinberg and Mittal list five common types of cases that were difficult to categorize and that “highlighted the complexity of adjudicating between clinical practice and the contemporary regulatory environment.”
1) secondary-prevention indication when the presentation was syncope in the setting of cardiomyopathy;
2) concurrent trivial cardiac enzyme leak or enzyme elevation for non-MI reasons but coded as acute MI;
3) ICD implantation when the precipitating acute device need was bradycardia and pacemaker indication;
4) incomplete or incidental percutaneous revascularization not anticipated to have any meaningful effect on chronic LV dysfunction; and
5) ICD implantation near the end of the 90-day post-revascularization period when the patient was admitted for heart failure.
The authors help dispel fears about government intransigence:
We found the government legal team highly knowledgeable and informed. The lawyers listened thoughtfully to our presentation about the results of our review and how we viewed the balance between complying with the letter of claims regulations and the subtleties of clinical practice. They were quite sensitive to avoiding situations that could present harm to the patients simply to satisfy the coding guidelines and, in large part, were receptive to the “exceptions” that are detailed in the preceding text.
Following the review, coding procedures were changed, and EPs who implant ICDs now carefully document the indication for the device and include all relevant mitigating circumstances. All cases are preceded by a “concurrent peer review during a morning conference call of practicing EPs,” and quality assurance reviews are performed afterward.
March 27th, 2012
Presentation Day, At Last
Jeremiah Depta, MD
Several Cardiology Fellows who are attending ACC.12 this week are blogging together on CardioExchange. The Fellows include Tariq Ahmad, Bill Cornwell, Megan Coylewright, Jeremiah Depta, and John Ryan (moderator). Read the previous post here. For more on Fellows’ experiences in presenting research, see Amit Shah’s post from AHA in 2011, John Ryan’s post from AHA in 2010, and his interview in 2011 with Thomas Ryan].
Monday morning, my co-author Dr. Jeffrey Fowler and I had the opportunity to present our study, “Clinical Outcomes Using a Platelet-function Guided Approach for Prevention of Ischemic Events in Patients with Stroke or TIA.”
The study was a retrospective observational study of ischemic stroke and TIA patients on aspirin and/or clopidogrel who underwent platelet function testing and whose antiplatelet therapy was either maintained (i.e. same dosages) or modified (i.e. increased the dosage or added/changed to a more potent agent). We found that antiplatelet therapy modification was associated with increased adverse outcomes, mainly driven by an increase in bleeding events, compared with no modification.
The project was conceptualized during my intern year at Cleveland Clinic. I was on the stroke service and was asked by the attendings to order platelet function tests to assess for adequate inhibition in ischemic stroke and TIA patients. I had been reading about platelet function testing for several years before this experience and began working on a review article on this topic with my mentor, Dr. Deepak Bhatt. I remember asking the neurology attendings as to the available evidence for this therapeutic approach in this patient population and many of them recognized that the evidence was lacking. With the help of Dr. Fowler, we were able to collect detailed data on clinical outcomes with ~ 4.5 year follow-up. It was incredibly gratifying to finally present the data from one of the first clinical research projects I had conceptualized during my intern year.
We presented in the session entitled, How to Pick your Antiplatelet Therapy. When we arrived, we realized that ours was one of the few studies that concluded that adjusting antiplatelet therapy based on platelet function testing was not helpful, even potentially harmful, in our patient population. Dr. Fowler and I both felt we would be met with significant criticisms. The moderator for the session was Dr. Dominick Angiolillo, who is a luminary in the field of antiplatelet therapy and platelet function testing. I have read numerous articles by him and felt very honored to have him review our study. To our surprise, we did not meet with an incredible amount of criticism from him and other individuals who stopped by our poster. We were very careful to mention the study limitations associated with our study, which I think helped to ease any major reproaches.
The opportunity to present your research and get feedback from experts in the field is invaluable. I have presented at prior ACC poster sessions, but this was my first moderated poster session. I applaud the ACC for assigning experts to moderate the sessions and give feedback to the presenters, many of whom are residents/fellows/junior faculty. The interactions are vital and allow one to get instant feedback and discussion about their research project.
All in all, it was a fantastic experience to finally present data on a project that was started “many” years ago and too many “calls” to count.
March 27th, 2012
Transitioning from Trainee to Attending? The Business Details
William Kent Cornwell, MD
Several Cardiology Fellows who are attending ACC.12 this week are blogging together on CardioExchange. The Fellows include Tariq Ahmad, Bill Cornwell, Megan Coylewright, Jeremiah Depta, and John Ryan (moderator). Read the previous post here. Read the next one here.
As trainees, we are so preoccupied with learning the fundamentals of cardiology that we have hardly any time to learn, or even think about, the business of medicine. Fortunately, Dr. Justin Matthew Bachmann, chair of the ACC Fellow in Training Center, organized on Monday a great session on career development to help us gain a better understanding of some critical issues, which we need to be familiar with as soon as we enter the workforce. For example, regarding interviewing and contract negotiations, there are many general things to mull over, like group strengths and interests, key affiliations, electronic medical records and liability claims. Specific considerations include meeting the practice manager and determining whether you agree with how he/she runs the group.
What about the contract length? Terms and termination? Assistance with relocating? Loan repayment assistance? CME allowance? These are important for both the applicant and the employer. According to Susan Childs, founder of Evolution Healthcare Consulting, groups can spend excessive amounts of money on recruiting and relocating new partners, sometimes in excess of $100,000. In light of these numbers, it is critical that the “t”s are crossed, the “i”‘s dotted, and no stone left unturned when determining whether a group is the right fit for you and you are the right fit for the group. Childs explained that job dissatisfaction usually stems from a failure to clearly define terms during contract negotiations; so this issue is critically important when transitioning from fellow to attending physician.
Financial planners were also present and offered counseling for those of us who have accrued exorbitant amounts of debt. According to Michael Merrill, of Finity Group, the average graduate has $180,000 of debt upon entering the workforce. His goal for trainees is “Become worthless!” — meaning reach the point where you are finally out of the red with a net worth of zero. Some goal! He offered tips to achieve this goal, including meeting with financial planners to establish good money management strategies early, before we “get those contracts” with the big bucks. Merrill explained that all too often he meets with cardiologists who only worsened their debt by making poor decisions with regard to their finances. Early financial planning clearly is another critical piece in the transition from trainee to attending.
Fellows simply don’t have time during their training to consider these issues to any appreciable extent. This was a great opportunity for experts to reinforce important principles, from identifying the right group to negotiating a contract, starting financial planning, and establishing healthy financial habits.
March 27th, 2012
ASCERT Observational Study Finds Long-Term Advantage for CABG over PCI in High-Risk Cases
Larry Husten, PHD
A very large observational study finds that long-term mortality in high-risk patients is lower after bypass surgery than after PCI. The results, which were first revealed in January at the annual meeting of the Society of Thoracic Surgeons (STS), were presented in final form at the American College of Cardiology by William Weintraub and published simultaneously in the New England Journal of Medicine.
ASCERT (ACCF and STS Database Collaboration on the Comparative Effectiveness of Revascularization Strategies) is an NHLBI-funded study based on linked data from the STS, the ACC, and Centers for Medicare and Medicaid Services. The study population included patients 65 or older with two- or three-vessel disease who underwent CABG or PCI in the period from 2004 through 2008. Nearly 190,000 patients were followed in the study; 103,549 received PCI and 86,244 underwent CABG. Median follow-up was 2.67 years.
One-year adjusted mortality:
- 6.24% for CABG and 6.55% for PCI (RR 0.95, CI 0.90-1.00)
Four-year adjusted mortality:
- 16.4% versus 20.8% (RR 0.79, CI 0.76-0.82)
The findings, the authors say, are consistent with data from previous observational and randomized trials. But, they acknowledge, “the potential remains for unmeasured confounders to have influenced the findings.”
In an accompanying editorial, Laura Mauri writes that “it is plausible that, in patients with diffuse atherosclerosis, CABG reduces the risk of fatal myocardial infarction more effectively than does focal treatment.” But she expressed skepticism that CABG could be shown to be better in two-vessel disease or in patients with three-vessel disease with focal lesions. ASCERT also does not reflect either the recent advances in PCI technology or the “modern PCI strategies” that reserve PCI for ischemic lesions, she writes.
Observational studies can provide valuable information, “but there is no substitute for randomized trials to eliminate selection bias between treatments,” Mauri adds. She concludes: “we must … continue to give priority to randomized trials on the most salient questions regarding treatment strategy.”
March 26th, 2012
Rivaroxaban Found Safe and Effective for Pulmonary Embolism
Larry Husten, PHD
In recent years rivaroxaban has been found to be effective in the prevention of venous thromboembolism (VTE) after orthopedic surgery, for the prevention of stroke in AF patients, and as additional therapy to conventional antiplatelet therapy in ACS patients. Now, a study presented at the American College of Cardiology meeting in Chicago and published simultaneously in the New England Journal of Medicine offers strong evidence that rivaroxaban is equally effective as standard therapy for the treatment of pulmonary embolism and may cause fewer bleeding complications.
EINSTEIN-PE was a randomized, open-label, non-inferiority study comparing rivaroxaban to conventional therapy with enoxaparin and a vitamin K antagonist in 4,832 patients with pulmonary embolism. Rivaroxaban met the predefined margin for noninferiority to conventional treatment with respect to both clinical efficacy and safety.
Primary efficacy endpoint (first symptomatic recurrent VTE):
- 2.1% for rivaroxaban patients versus 1.8% for standard therapy (HR, 1.12; 95% CI, 0.75-1.68; P=0.003 for noninferiority)
Principal safety outcome (major or clinically relevant bleeding):
- 10.3% versus 11.4% (HR, 0.90; 95% CI, 0.76-1.07; P=0.23 for noninferiority) for rivaroxaban and standard therapy, respectively
Major bleeding was significantly lower in the rivaroxaban group:
- 1.1% versus 2.2% (HR, 0.49; P=0.003) for rivaroxaban and standard therapy, respectively
Net clinical benefit (VTE plus major bleeding):
- 3.4% versus 4.0% (HR, 0.85; 95% CI, 0.63-1.14; P=0.28) for rivaroxaban and standard therapy, respectively
“Physicians want to know about major bleeding, the most important safety outcome, and rivaroxaban was highly significantly superior. This was our most astonishing finding,” said EINSTEIN chair Harry Buller in an ACC press release. “Rivaroxaban is just as good as standard treatment for PE – these data are pretty convincing – and this is an oral-only approach, which makes it very simple. The subcutaneous injections can be hazardous as well.”
The EINSTEIN investigators concluded that, in conjunction with the earlier EINSTEIN trial in DVT, the EINSTEIN PE trial supports “the use of rivaroxaban as a single oral agent for patients with venous thromboembolism.”
March 26th, 2012
ACC: Not a Straightforward Science Meeting
Megan Coylewright, MD MPH
Several Cardiology Fellows who are attending ACC.12 this week are blogging together on CardioExchange. The Fellows include Tariq Ahmad, Bill Cornwell, Megan Coylewright, Jeremiah Depta, and John Ryan (moderator). Read the previous post here. Read the next post here.
My two posters are done, and now on to a full day of sessions.
One of the great things about presenting a poster is meeting the other folks in your section — mine is Outcomes Research. The relationships were formed over the shared experience of putting up the bulky evidence of our hard work, and the expression of heartfelt interest is very welcome.
Fun to read Sandeep’s health policy piece. There are such diverse offerings at ACC — which I had traditionally viewed as a straightforward science meeting — that there is truly something for everyone. The education component is particularly strong this year, thanks to Dr. Nishimura and Dr. O’Gara.
Starting at noon, I’ll be interviewing fellows for the ACC FIT blog. The push to get us involved this year seems to have paid off, as there is a big fellow presence. Fellows’ Bootcamps today are packed. Get there early for a seat.
March 26th, 2012
An Inspiring Run
William Kent Cornwell, MD
Several Cardiology Fellows who are attending ACC.12 this week are blogging together on CardioExchange. The Fellows include Tariq Ahmad, Bill Cornwell, Megan Coylewright, Jeremiah Depta, and John Ryan (moderator). Read the previous post here. Read the next one here.
Hats off to everyone who made it out for the CardioSmart 5K run this morning! I wish I could say it was a morning typical of my hometown of Dallas TX — sun shining, probably 70 degrees, maybe a few clouds. If only….
In reality, it was about 35 degrees, strong winds made worse by the lakefront course. If that weren’t enough, crashing waves along the waterfront spilled over onto the path, showering some poor souls who were already at their wits’ end with the weather. Fortunately the sleet waited until the race was nearly over. Despite all that, the 5K run was a great time. Several hundred of our colleagues and friends made it out, and thanks to the ACC for organizing the run.
The run was dedicated to the memory of a past ACC president, Dr. Henry McIntosh. What an inspiration this man was, and continues to be, to fellows in training and cardiologists across the country. He voluntarily left medical school during World War II to join the US Parachute Infantry Office and was decorated for his service. His contributions to medicine and society in general are too many to count, but one notable accomplishment was the creation of Heartbeat International, whose purpose is to provide pacemakers to indigent people throughout the world. As of 2009, over 9,000 people benefited from this organization. After formally retiring from medicine, he began volunteering for uninsured patients near his home in Florida. Dr. McIntosh truly was a great man — a good man, an inspiration for us all, and fitting that the race was named in his honor.
Thanks again to the ACC for putting on the 5K.
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