“Should SCAI update its position on the role of Public Reporting?”

The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is held annually bringing together expert opinion from interventional cardiologists, administrative partners and select members of the cardiovascular industry community in a collaborative venue. During the SCAI 2018 Scientific Session, topics in interventional cardiology felt to be relevant to the contemporary practice of the field were identified with the goals of defining the state of the field, current challenges, and future directions. By publishing the proceedings, the wider cardiovascular community can participate in this discussion and add their voice to the debate, helping SCAI proceed with specific action items in the future. The Think Tank is a partnership between SCAI, the SCAI Emerging Leader Mentorship Program (ELM), select SCAI committees, and industry partners within the SCAI Corporate Community. We thank them for their participation in this venture. Public reporting of outcomes following percutaneous coronary intervention (PCI), particularly risk-adjusted mortality rates (RAMR), has been in place in certain communities for over two decades and more recently has been implemented in various mandatory and voluntary forms at the state (e.g., New York, Massachusetts, Texas, Washington) and societal levels. The RAMR is not an accurate reflection of operator quality, since the mortality after PCI is very much dependent on the clinical acuity at presentation, patient comorbidities and postprocedural care, and not solely on the operator's technical proficiency. The public reporting processes are varied and uncoordinated and may have unintended public health consequences in their subtended communities.1 Risk-averse behavior has been identified as one of the unintended consequences of reporting RAMR and has led to various state-level solutions to solve this public health problem (i.e., eliminating very high-risk patients from the reported risk-adjusted data or creating separate models for the high-risk cases). In response to the rise in public reporting programs, a growing body of scientific literature has raised concerns about the impact of PCI public reporting, particularly as it relates to statistical methodology and case selection.2-6 Specifically, concerns have been raised that operators in public reporting states more frequently consciously “game the system” or unconsciously avoid pursuing appropriate and indicated treatment in high-risk scenarios due to concerns about their RAMR and “public shame”. In fact, in a recent analysis, 65% of interventional cardiologists surveyed in Massachusetts and New York admitted to avoiding PCI at least twice over concerns about the potential negative impact of a bad outcome.7 Unfortunately, it is just such high-risk patients who have the largest mortality benefit from PCI, a conundrum known as the “risk-treatment paradox”, wherein those with the highest potential mortality benefit from treatment simultaneously have the worst overall outcomes following treatment. In 2016, SCAI published a comprehensive revision to its position statement on public reporting8 addressing many of these on-going concerns. Despite this and other scientific statements identifying limitations and challenges to the public reporting process,9-11 there have been few, if any, recent changes to PCI public reporting processes. There are many potential reasons for this, including: (a) decentralized governance structure, (b) the perception that transparency is “here to stay” irrespective of current limitations, (c) skepticism about the currently reported data, and/or (d) sense that the values of public reporting outweigh the adverse consequences. In the 2018 SCAI Think Tank Session, the participants and SCAI leadership debated the merits of updating SCAI's position on public reporting. The group recognized that any policy positions in regard to publicly reporting institutional or operator-specific outcomes will also need to consider national, state and local credentialing processes. To the extent that public reporting's raison d'etre is to assist our patients in making better decisions, to ensure minimum competencies and to identify poor performers, public reporting is intertwined with pre-existing federal, state and hospital-system credentialing processes. These processes for individual PCI operators have evolved over time to reflect lower national operator volumes. Much has been debated in regards to operator volume as a surrogate for quality,12 but it currently stands as the primary operator credentialing benchmark. SCAI has recently endorsed a decrease in threshold operator volume to ≥50 PCIs per year, averaged over 2 years.13 This, of course, represents the minimum plausible standard, but the group agrees that more rigorous local standards, including non-volume based metrics, may be agreed upon befitting the types of patients and disease complexity typically cared for at a particular center or in a specific geographic region. Responsibility for enforcing such standards is heterogeneous based on each hospital system and could be a point of standardization. At the hospital system level, the Certificate of Need (CON) process, largely put in place as a part of the Health Planning Resources Development Act of 1974, is tasked with regulating the institution of new cardiac catheterization laboratories and arguably validates the continued existence of those in place based on procedural volume and unmet needs within each community. However, CON requirements and processes are enacted at the state level and large degrees of variation exist, which is reflected in the marked differences in average PCI operator volumes by state.14 This may also be an opportunity for reevaluation and standardization. In a similar vein, the SCAI Think Tank endorses the creation and maintenance of regional systems of care and centers of excellence for high risk cohorts (e.g., out-of-hospital cardiac arrest, cardiogenic shock) as previously endorsed by the American Heart Association9, 10 and others. Data identifying centers of excellence within a geographic region for particular high-risk cohorts could be publicly disclosed and patients would benefit from being triaged to such centers of excellence by emergency medical services. Regional systems of care organized around various conditions naturally lend themselves to disease-based reporting, rather than procedure-based reporting as is currently the standard in public reporting processes. The group strongly endorses disease-based registries in an effort to mitigate risk-aversion and better study disease-based best practices. Therefore, outcomes would be reported even if PCI or coronary artery bypass graft surgery are not performed and poor outcomes from risk averse behavior would not be overlooked. Such a plan would also obviate debates regarding exclusions or additional risk adjustment of the highest risk patients from procedure-based observed-to-expected mortality models. The group endorses a robust program to ensure rigorous minimum competencies for PCI operators and institutions. This may take many forms including updated credentialing processes and/or public reporting of data on credentialed operators. The group continues to support public reporting as a means to encouraging institutions and operators to strive for improvements in outcomes, however, SCAI recommended de-emphasizing public reporting of RAMR (particularly physician-specific RAMR) as the sole or summary measure of quality. The group emphasized the importance of excluding high-risk patients from reports to the public, and/or instituting processes to allow external peer review of all mortality cases prior to public reporting. A shift away from RAMR as the primary metric of reporting toward quality of care processes impacted by the operator or institution, such as the incidence of developing contrast-induced nephropathy or the proportion of patients meeting appropriate use criteria, would likely help to mitigate risk aversion and focus on process-driven best practices. Identifying and discussing topics for which we need a more concrete path forward is a key goal within SCAI. The above discussions and presentations will hopefully serve to inform the cardiovascular and interventional community regarding SCAI's vision for the future directions. While in some cases, the discussion will result in a discrete action item, such as a consensus document, new advocacy goals, or specific committee or education work, in other cases, the discussion will serve to broaden our understanding especially with regards to the state of consensus, or lack thereof. The group welcomes the larger interventional community's analysis of these discussions and participation in shaping the profession's future. Nothing to report.