Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies.

BACKGROUND: The Transcatheter Valve Therapy (TVT) Coordinated Registry Network (CRN) supported 23 regulatory decisions and ensured evidence-based evaluation of the application of TVT technology. However, there are cost concerns that require value assessment of the TVT CRN compared with traditional study designs. OBJECTIVES: We aimed to determine the value created by the TVT CRN based on (1) Return on investment (ROI), (2) Time saved (TS) in conducting necessary regulatory studies. METHODS: For both ROI and TS analyses, we compared studies that used the TVT CRN with those that would have been required if the registry did not exist (counterfactual studies). To estimate ROI, we accounted for the costs of investment and gain from investment. Both the counterfactual costs and length of studies were projected using design specifications determined by US Food and Drug Administration (FDA) reviewers. RESULTS: We identified 21 studies using the TVT CRN (supporting 23 FDA decisions) that generated evidence on TVT for three device manufacturers. ROI is estimated to be greater than 550%. TS by using the CRN ranged from months to years. CONCLUSIONS: The CRN method to evidence generation creates value for manufacturers and the broader device ecosystem, demonstrated with this example of the TVT CRN. The public health benefits of evidence created by this CRN outweighs the difference in data quality between traditional clinical studies and the CRN method.

A Survey of Interventional Cardiologists' Attitudes and Beliefs About Public Reporting of Percutaneous Coronary Intervention.

Importance: Public reporting of procedural outcomes has been associated with lower rates of percutaneous coronary intervention (PCI) and worse outcomes after myocardial infarction. Contemporary data are limited on the influence of public reporting on interventional cardiologists' clinical decision making. Objective: To survey a contemporary cohort of interventional cardiologists in Massachusetts and New York about how public reporting of PCI outcomes influences clinical decision making. Design, Setting, and Participants: An online survey was developed with public reporting experts and administered electronically to eligible physicians in Massachusetts and New York who were identified by Doximity (an online physician networking site) and 2014 Medicare fee-for-service claims for PCI procedures. The personal and hospital characteristics of participants were ascertained via a comprehensive database from Doximity and the American Hospital Association annual surveys of US hospitals (2012 and 2013) and linked to survey responses. Associations between survey responses and characteristics of participants were evaluated in univariable and multivariable analyses. Main Outcomes and Measures: Reported rate of avoidance of performing PCIs in high-risk patients and of perception of pressure from colleagues to avoid performing PCIs. Results: Of the 456 physicians approached, 149 (32.7%) responded, including 67 of 129 (51.9%) in Massachusetts and 82 of 327 (25.1%) in New York. The mean (SD) age was 49 (9.2) years; 141 of 149 participants (94.6%) were men. Most participants reported practicing at medium to large, nonprofit hospitals with high-volume cardiac catheterization laboratories and cardiothoracic surgery capabilities. In 2014, participants had higher annual PCI volumes among Medicare patients than nonparticipants did (median, 31; interquartile range [IQR], 13-47 vs median, 17; IQR, 0-41; P < .001). Among participants, 65% reported avoiding PCIs on at least 2 occasions becase of concern that a bad outcome would negatively impact their publicly reported outcomes; 59% reported sometimes or often being pressured by colleagues to avoid performing PCIs because of a concern about the patient's risk of death. After multivariable adjustment, more years of experience practicing interventional cardiology was associated with lower odds of PCI avoidance. The state of practice was not associated with survey responses. Conclusions and Relevance: Current PCI public reporting programs can foster risk-averse clinical practice patterns, which do not vary significantly between interventional cardiologists in New York and Massachusetts. Coordinated efforts by policy makers, health systems leadership, and the interventional cardiology community are needed to mitigate these unintended consequences.

Early results of Massachusetts healthcare reform on racial, ethnic, and socioeconomic disparities in cardiovascular care.

BACKGROUND: Insured adults receive invasive cardiovascular procedures more frequently than uninsured adults. We examined the impact of healthcare reform in Massachusetts on use of coronary revascularization procedures and in-hospital and 1-year mortality by race/ethnicity, education, and sex. METHODS AND RESULTS: Using hospital claims data, we compared differences in coronary revascularization rates (coronary artery bypass grafting or percutaneous coronary intervention) and in-hospital mortality by race/ethnicity, education, and sex among Massachusetts residents aged 21 to 64 years hospitalized with a principal discharge diagnosis of ischemic heart disease before (November 1, 2004, to July 31, 2006) and after (December 1, 2006, to September 30, 2008) reform; 1-year mortality was calculated for those undergoing revascularization. Adjusted logistic regression assessed 24 216 discharges before reform and 20 721 discharges after reform. Blacks had 30% lower odds of receiving coronary revascularization than whites in the prereform period. Compared with whites in the postreform period, blacks (odds ratio=0.73; 95% confidence interval, 0.63-0.84) and Hispanics (odds ratio= 0.84; 95% confidence interval, 0.74-0.97) were less likely and Asians (odds ratio=1.29; 95% confidence interval, 1.01-1.65) were more likely to receive coronary revascularization. Patients living in more educated communities, men, and persons with private insurance were more likely to receive coronary revascularization before and after reform. Compared with the prereform period, the adjusted odds of in-hospital mortality were higher in patients living in less-educated communities in the postreform period. No differences in 1-year mortality by race/ethnicity, education, or sex for revascularized patients were observed before or after reform. CONCLUSIONS: Reducing insurance barriers to receipt of coronary revascularization procedures has not yet eliminated preexisting demographic and educational disparities in access to these procedures.