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Published on: June 12, 2021
Government Regulation and Percutaneous Coronary Intervention Volume, Access and Outcomes: Insights From the
Akash Kataruka1, Charles C Maynard2, Ravi S Hira3
1Division of Cardiology University of Washington Seattle WA.
Insights
Washington State
Area of Science:
- Cardiovascular Medicine
- Health Policy
- Health Services Research
Background:
- Geographic distribution of percutaneous coronary intervention (PCI) programs is not optimized for patient outcomes.
- Washington State's Certificate of Need (CON) program regulates elective PCI to balance hospital volume and patient access.
- Current CON policies may lead to suboptimal outcomes and access.
Purpose of the Study:
- To evaluate the impact of Washington State's Certificate of Need (CON) program on the geographic distribution and outcomes of percutaneous coronary intervention (PCI) programs.
- To assess whether current regulations effectively balance hospital volume and patient access for PCI services.
Main Methods:
- Retrospective cohort study of non-Veterans Affairs hospitals with PCI programs in Washington State (2009-2018).
- Hospitals categorized into three groups: legacy (full services with surgical backup), new certificate of need (CON) (full services without surgical backup), and myocardial infarction (MI) access (nonelective PCI only).
- Analysis of hospital volumes, patient access times, and risk-adjusted mortality rates.
Main Results:
- Legacy hospitals had the highest annual median volumes, followed by new CON and MI access hospitals.
- Risk-adjusted mortality for nonelective PCI was lower in legacy and new CON hospitals compared to MI access hospitals.
- Adding new CON and MI access hospitals provided only a marginal increase (1.5%) in population access within 60 minutes.
Conclusions:
- Many PCI programs in Washington State operate below minimum volume standards despite CON regulations.
- The CON strategy has created a tiered system with low-volume centers treating high-risk patients, leading to poorer outcomes without substantial gains in geographic access.
- Certificate of Need policies require re-evaluation regarding the number and distribution of PCI programs to improve patient outcomes and access.
Abstract:
Background It is unclear how to geographically distribute percutaneous coronary intervention (PCI) programs to optimize patient outcomes. The Washington State Certificate of Need program seeks to balance hospital volume and patient access through regulation of elective PCI. Methods and Results We performed a retrospective cohort study of all non-Veterans Affairs hospitals with PCI programs in Washington State from 2009 to 2018. Hospitals were classified as having (1) full PCI services and surgical backup (legacy hospitals, n=17); (2) full services without surgical backup (new certificate of need [CON] hospitals, n=9); or (3) only nonelective PCI without surgical backup (myocardial infarction [MI] access hospitals, n=9). Annual median hospital-level volumes were highest at legacy hospitals (605, interquartile range, 466-780), followed by new CON, (243, interquartile range, 146-287) and MI access, (61, interquartile range, 23-145). Compared with MI access hospitals, risk-adjusted mortality for nonelective patients was lower for legacy (odds ratio [OR], 0.59 [95% CI, 0.48-0.72]) and new-CON hospitals (OR, 0.55 [95% CI, 0.45-0.65]). Legacy hospitals provided access within 60 minutes for 90% of the population; addition of new CON and MI access hospitals resulted in only an additional 1.5% of the population having access within 60 minutes. Conclusions Many PCI programs in Washington State do not meet minimum volume standards despite regulation designed to consolidate elective PCI procedures. This CON strategy has resulted in a tiered system that includes low-volume centers treating high-risk patients with poor outcomes, without significant increase in geographic access. CON policies should re-evaluate the number and distribution of PCI programs.
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