Traditionally, as each year comes to a close, we take a look back at the most dominating events that will most likely prove impactful for years to come. For the interventional cardiology field 2012 was a transitional year with respect to innovative technologies and matured pharma in clinical use. Nearly 10 years after the first percutaneous aortic valve replacement was performed by Dr. Alain Cribier, transcatheter aortic valve replacement (TAVR) with the Edwards Sapien valve was approved for marketing in the US for treatment in inoperable patients with aortic stenosis. In 2012 we witnessed continued growth in evidence-based medicine for structural heart disease, especially with regard to patent foramen ovale closure for secondary stroke prevention. We also saw more supportive data with respect to left atrial closure devices, and the use of the mitral clip for functional mitral regurgitation. Also, more patients with acute coronary syndrome were treated with third-generation antiplatelet therapy like prasugrel and ticagrelor. Second-generation drug-eluting stents (DES) continued to replace first-generation DES with continued reports of lower target revascularization and stent thrombosis rates, suggesting that the duration of dual antiplatelet therapy may be shortened from 12 to 6 months, and perhaps even 3 months. Finally, the Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS) was approved for marketing in commercial percutaneous coronary intervention (PCI) worldwide (save for the US) following intensive investigational efforts lasting more than a decade. Without a clear winner in the domination category, I found that the appropriateness use criteria (AUC), which were disseminated to nearly every hospital in the US, were the dominant factor impacting the way we practiced medicine in 2012.

The AUC for PCI and medical therapy were an initiative presented by professional societies such as the American Heart Association, American College of Cardiology Foundation, and the Society for Cardiovascular Angiography and Interventions to promote safety, quality, and appropriate use of PCI in a variety medical and lesion scenarios. Since the publication of the AUC for PCI in 2009 , the AUC and its implementation in daily practice have been the subject of growing debate and controversy. In 2012 this debate was no longer limited to the interventional cardiology field; it crossed over to noninvasive imaging and other disciplines and was covered heavily by the media.

The AUC became an industry in of itself with designated training programs, documentation, auditing, and payment adjustment by the providers. The art of medicine is now being replaced by AUC. As a result, there is growing confusion among physicians and industry professionals on how to implement the AUC in daily practice. There are increased compliance monitoring and reporting, which are making physicians second guess when to intervene without fractional flow reserve (FFR) or intravascular ultrasound (IVUS) documentation; a few physicians have already given up intervention in the stable patient. As a result, the overall number of PCIs in the US is dramatically shrinking at an estimated rate of 5%–8% per year. Further, the fear of being scrutinized for the PCI indication and the lack of reimbursement for the uncertain criteria have led to a reduction in PCI volume, even in patients with ST-elevation myocardial infarction (STEMI).

Because of public reporting, which may have its advantages, patients who present with acute MI are less likely to have primary PCI in states that require cath labs to publicly report their data. In the past, the same was true for surgery and other disciplines. The AUC should not only call attention to overuse but should discourage underuse when the procedure is necessary. At this stage we should recognize that both overuse and underuse of PCI should be a national healthcare priority. More physicians and patient advocates need to be involved in the process.

The COURAGE trial , published in 2007, had a huge impact on PCI for patients with stable angina. It advocated optimal medical therapy as an alternative to PCI. Some believe that the trial results accelerated the formation and content of the AUC in 2009. It will be interesting to see what impact the FREEDOM trial (presented in 2012) will have on the management of diabetes with respect to treatment (medical therapy versus revascularization). Although both studies favored medical therapy, it is important to recognize that only 20% of patients adhere to optimal medical therapy over time. Interestingly, the AUC ignore patient preference when it comes to selecting the appropriate treatment. Patients should have a say when it comes to AUC; they should be able to choose between medical therapy to relieve angina over a 3-month period or PCI to relieve the angina overnight.

Although the AUC are an important tool, they should only be used when a high level of accuracy can be reached using meticulous methodology and models to predict outcome. The use of FFR, as was demonstrated in the FAME 2 trial published in 2012, or another objective diagnostic tool, such as IVUS or a stress test, should be incorporated into the methodology in order to fine tune the AUC and reflect a broad, real-world clinical scenario. We should recognize that the AUC are not a mathematical model and they should not interfere with the art of medicine and individualized tailored medicine. Reimbursement considerations, fear of audit transparency, and public reporting are welcomed but should not impact patient care.

Interestingly, a recent study (2012) out of Massachusetts reported that patients with STEMI are less likely to undergo primary PCI in states requiring cath labs to publicly report their data than in those states that don’t. In contrast, a different study published in 2012, from Ontario, Canada, demonstrated that following the AUC was associated with improved outcome and under use could be harmful .

As AUC are being developed and disseminated across many disciplines (not only cardiology), it is imperative that more individuals make up the team that defines and assesses the level of appropriateness. This will help to change the culture that finds the interventional cardiologist “guilty” until proven otherwise. If 2012 was the year of appropriateness, let’s hope that 2013 is the year of correction. Further revision of the AUC to improve accuracy and refine methodology is necessary for better patient care.