The oft-quoted G.K. Chesterton said that the “ fatal metaphor of progress, which means leaving things behind us, has utterly obscured the real idea of growth, which means leaving things inside us.” Today is my final day at Cardiovascular Business, where I am grateful to have worked and grown for the past seven years.
Here are a few snippets of the meager knowledge that I garnered as an observer of this space:
- Even evidence-based standards require the infusion of informed human decision-making. Appropriate use criteria, which most practitioners and administrators value as an important source for evidence-based care, has recently undergone a facelift because of concerns that the previous terminology demonized informed decision-making of physicians. Some, such as the Society for Cardiovascular Angiography and Interventions president, are asking if the changes went far enough.
- Behavioral change for cardiologists is a peculiar thing, regardless of what the literature says. It may take a massive force or just a long period of time, for “a cardiologist to change his or her spots,” said Paul A. Gurbel, MD, about the lack of uptake of prasugrel and ticagrelor. Despite the positive outcomes of the wildly expensive TRITON TIMI trials and particularly the mortality benefit seen in the comparatively expensive PLATO trial, there has been very little uptake of either newer antiplatelet in the U.S. This trend is likely to continue now that clopidogrel is generic. The anticoagulant Pradaxa is seeing a surprisingly similar fate. Conversely, the bleeding benefits seen with the more costly bivalirudin in ACUITY and HORIZONS AMI has led to quarter-over-quarter gains for The Medicines Company. What gives?
- Obamacare has taken effect. And yet, very few providers are preparing for the massive influx of governmentally insured patients in 2014.
- The more impactful reform will come through new reimbursement models. For several years the healthcare community has spoken about the demise of the fee-for-service model, which could drastically impact inpatient cardiology services. Yet, there may be some light if cardiologists choose to “own” their patients’ care through patient-centered medical homes, and some C-suite level executives are readying themselves for this rockier landscape.
- Some clinical questions may never get answered. Case in point: Should proton pump inhibitors be contradicted to clopidogrel? 'Nuff said.
- Large-scale clinical trials are incredibly difficult to orchestrate and execute. While this is a trite and obvious statement, it never was so apparent until I covered ATLAS-ACS 2, a randomized trial including more than 15,000 patients in 44 countries that showed a mortality benefit when adding rivaroxaban to dual-antiplatelet therapy for two different dosages. At its AHA.11 presentation, discussion focused on the targets of thrombins vs. platelets and appropriate dosing, along with the real concern about bleeds in the trial. Yet, during the FDA panel, the biggest attention was paid to the 8 percent of patients in whom complete data were missing and trial design, despite an impassioned advocacy from Eugene Braunwald, MD, for the possibilities of triple therapy. Two years later, the FDA is still requesting more information, and questions about whether this drug could change practice have never been thoroughly vetted out.
- Listen to Drs. Topol and Fitzgerald. In part due to the arduous regulatory process in the U.S., the next-generation of cardiovascular innovation may not be a clunky metallic device that gets implanted within patients in whom physicians are uncertain of benefit. Instead, mobile devices will improve patient engagement and understanding of their own conditions, and for these devices, the FDA is helping modernize its regulatory pathway. Quick on the heels of the mHealth revolution is personalized care through genomics.
- TAVR is here to stay, but questions about durability and patient selection remain. Unfortunately, the true next-generation transcatheter aortic valve replacement device won't be seen in the U.S. for another five to six years.
- Medical meetings may no longer be dictated by blockbuster trials. Due to recent inadvertent embargo breaks either from the press, industry (such as at ACC.13) or professional societies themselves, many have questioned the appropriateness of the current embargo process in the digital age of information. If this changes, late-breaking clinical trials may lose