The bleeding risk treatment paradox at the physician and hospital level: Implications for reducing bleeding in patients undergoing percutaneous coronary intervention.

BACKGROUND: Bleeding is a common and costly complication of percutaneous coronary intervention (PCI). Bleeding avoidance strategies (BAS) are used paradoxically less in patients at high-risk of bleeding: "bleeding risk-treatment paradox" (RTP). We determined whether hospitals and physicians, who do not align BAS to PCI patients' bleeding risk (ie, exhibit a RTP) have higher bleeding rates. METHODS: We examined 28,005 PCIs from the National Cardiovascular Data Registry CathPCI Registry for 7 hospitals comprising BJC HealthCare. BAS included transradial intervention, bivalirudin, and vascular closure devices. Patients' predicted bleeding risk was based on National Cardiovascular Data Registry CathPCI bleeding model and categorized as low (<2.0%), moderate (2.0%-6.4%), or high (≥6.5%) risk tertiles. BAS use was considered risk-concordant if: at least 1 BAS was used for moderate risk; 2 BAS were used for high risk and bivalirudin or vascular closure devices were not used for low risk. Absence of risk-concordant BAS use was defined as RTP. We analyzed inter-hospital and inter-physician variation in RTP, and the association of RTP with post-PCI bleeding. RESULTS: Amongst 28,005 patients undergoing PCI by 103 physicians at 7 hospitals, RTP was observed in 12,035 (43%) patients. RTP was independently associated with a higher likelihood of bleeding even after adjusting for predicted bleeding risk, mortality risk and potential sources of variation (OR 1.66, 95% CI 1.44-1.92, P < .001). A higher prevalence of RTP strongly and independently correlated with worse bleeding rates, both at the physician-level (Wilk's Lambda 0.9502, F-value 17.21, P < .0001) and the hospital-level (Wilk's Lambda 0.9899, F-value 35.68, P < .0001). All the results were similar in a subset of PCIs conducted since 2015 - a period more reflective of the contemporary practice. CONCLUSIONS: Bleeding RTP is a strong, independent predictor of bleeding. It exists at the level of physicians and hospitals: those with a higher rate of RTP had worse bleeding rates. These findings not only underscore the importance of recognizing bleeding risk upfront and using BAS in a risk-aligned manner, but also inform and motivate national efforts to reduce PCI-related bleeding.

Incremental Cost of Acute Kidney Injury after Percutaneous Coronary Intervention in the United States.

Contrast-induced acute kidney injury (AKI) is a common and severe complication of percutaneous coronary intervention (PCI). Despite its substantial burden, contemporary data on the incremental costs of AKI are lacking. We designed this large, nationally representative study to examine: (1) the independent, incremental costs associated with AKI after PCI and (2) to identify the departmental components of cost contributing to the incremental costs associated with AKI. In this observational cross-sectional study from the Premier database, we analyzed 1,443,297 PCI patients at 518 US hospitals from 1/2006 to 12/2015. Incremental cost of AKI from a hospital perspective obtained by a microcosting approach, was estimated using mixed-effects, multivariable linear regression with hospitals as random effects. Costs were inflation-corrected to 2016 US$. AKI occurred in 82,683 (5.73%) of the PCI patients. Those with AKI had higher hospitalization cost than those without ($38,869, SD 42,583 vs $17,167 SD 13,994, p <0.001). After adjustment, the incremental cost associated with an AKI was $9,448 (95% confidence interval $9,338 to $9,558, p <0.001). AKI was also independently associated with an incremental length of stay of 3.6 days (p <0.001). Room and board costs were the largest driver of AKI costs ($4,841). Extrapolated to the United States, our findings imply an annual AKI cost burden of 411.3 million US$. In conclusion, in this national study of PCI patients, AKI was common and independently associated with ∼$10,000 incremental costs, implying a substantial burden of AKI costs in US hospitals. Successful efforts to prevent AKI in patients who underwent PCI could result in meaningful cost savings.

Association of Same-Day Discharge After Elective Percutaneous Coronary Intervention in the United States With Costs and Outcomes.

Importance: Same-day discharge (SDD) after elective percutaneous coronary intervention (PCI) is associated with lower costs and preferred by patients. However, to our knowledge, contemporary patterns of SDD after elective PCI with respect to the incidence, hospital variation, trends, costs, and safety outcomes in the United States are unknown. Objective: To examine (1) the incidence and trends in SDD; (2) hospital variation in SDD; (3) the association between SDD and readmissions for bleeding, acute kidney injury (AKI), acute myocardial infarction (AMI), or mortality at 30, 90, and 365 days after PCI; and (4) hospital costs of SDD and its drivers. Design, Setting, and Participants: This observational cross-sectional cohort study included 672 470 patients enrolled in the nationally representative Premier Healthcare Database who underwent elective PCI from 493 hospitals between January 2006 and December 2015 with 1-year follow-up. Exposures: Same-day discharge, defined by identical dates of admission, PCI procedure, and discharge. Main Outcomes and Measures: Death, bleeding requiring a blood transfusion, AKI and AMI at 30, 90, or 365 days after PCI, and costs from hospitals' perspective, inflated to 2016. Results: Among 672 470 elective PCIs, 221 997 patients (33.0%) were women, 30 711 (4.6%) were Hispanic, 51 961 (7.7%) were African American, and 491 823 (73.1%) were white. The adjusted rate of SDD was 3.5% (95% CI, 3.0%-4.0%), which increased from 0.4% in 2006 to 6.3% in 2015. We observed substantial hospital variation for SDD from 0% to 83% (median incidence rate ratio, 3.82; 95% CI, 3.48-4.23), implying an average (median) 382% likelihood of SDD at one vs another hospital. Among SDD (vs non-SDD) patients, there was no higher risk of death, bleeding, AKI, or AMI at 30, 90, or 365 days. Same-day discharge was associated with a large cost savings of $5128 per procedure (95% CI, $5006-$5248), driven by reduced supply and room and boarding costs. A shift from existing SDD practices to match top-decile SDD hospitals could annually save $129 million in this sample and $577 million if adopted throughout the United States. However, residual confounding may be present, limiting the precision of the cost estimates. Conclusions and Relevance: Over 2006 to 2015, SDD after elective PCI was infrequent, with substantial hospital variation. Given the safety and large savings of more than $5000 per PCI associated with SDD, greater and more consistent use of SDD could markedly increase the overall value of PCI care.

Impact of Appropriate Use on the Estimated Radiation Risk to Men and Women Undergoing Radionuclide Myocardial Perfusion Imaging.

UNLABELLED: The impact of appropriate use criteria (AUC) for myocardial perfusion imaging (MPI) with SPECT on the estimated lifetime attributable risk (LAR) of cancer is unknown. METHODS: A cohort of 1,511 consecutive patients who underwent clinically indicated (99m)Tc-setamibi MPI were categorized into appropriate/uncertain (n = 823) versus inappropriate (n = 688) use groups according to the 2009 AUC and were prospectively followed for 27 ± 10 mo. Logistic regression models were used to determine the annualized probability of major adverse cardiac events (MACE) of cardiac death or myocardial infarction and the probability of revascularization within 6 mo of MPI, accounting for relevant covariates. We determined LAR for each subject on the basis of accepted risk estimates. We calculated MPI's benefit-to-risk ratios, defined by the annualized predicted MACE-to-LAR ratio and the predicted 6-mo-revascularization-to-LAR ratio. RESULTS: During follow-up, there were 22 MACE and 29 6-mo revascularizations. The administered radioactivity and effective radiation doses absorbed were similar between the study groups. Patients with inappropriate MPI had significantly higher LAR (median, 0.08% vs. 0.06%, P < 0.001), lower predicted MACE-to-LAR ratio (median, 1.5 vs. 4.3, P < 0.001), and lower predicted 6-mo-revascularization-to-LAR ratio (median, 5.4 vs. 15.5, P < 0.001). Women had higher LAR (median, 0.08% vs. 0.07%, P < 0.001) and lower predicted MACE-to-LAR ratio (median, 1.9 vs. 3.3, P < 0.001) and 6-mo-revascularization-to-LAR ratio (median, 4.4 vs. 17.5, P < 0.001). However, appropriate/uncertain use negated the difference between men and women in LAR (P = 0.94) and the predicted MACE-to-LAR ratio (P = 0.97). CONCLUSION: Inappropriate MPI use is associated with excess cancer risk and lower MPI's benefit-to-risk ratio. Appropriate/uncertain use neutralizes the sex gap in LAR with MPI.

Appropriate use criteria for SPECT myocardial perfusion imaging: Are they appropriate for women?

BACKGROUND: Several studies have reported that women are more likely to receive inappropriate SPECT myocardial perfusion imaging (MPI), suggesting gender disparity in AUC determination. We investigated the impact of gender on the diagnostic and prognostic utility of AUC. METHODS AND RESULTS: We analyzed a multi-site prospective cohort of 1511 consecutive patients (43.5% women) who underwent outpatient, community-based SPECT-MPI. Subjects were stratified into gender groups and appropriateness subgroups, and followed for 27 ± 10 months for cardiac death, myocardial infarction, and coronary revascularization. Women were more likely to receive inappropriate MPI (60.7% vs 33.8%, P < .001). Irrespective of appropriateness, women were less likely to have an abnormal MPI (6.1% vs 14.9%, P < .001), even after adjusting for clinical covariates [odds ratio = 0.40 (95% confidence interval = 0.26-0.60), P < .001]. Irrespective of appropriateness, women were at lower risk for MACE (composite of cardiac death, myocardial infarction, or coronary revascularization) after adjusting for clinical and imaging covariates [hazard ratio = 0.49 (95% confidence interval = 0.28-0.86), P = .01]. There was no interaction between gender and appropriateness group as a determinant of abnormal MPI or MACE (interaction P values ≥ .26), indicating that female gender was associated with similar relative risk of an abnormal MPI and MACE irrespective of appropriateness group. Abnormal MPI was similarly predictive of increased hazard of MACE in both genders, regardless of appropriateness (interaction P values ≥ .46). CONCLUSION: In this multi-site cohort, there was no demonstrable gender-based differential impact of AUC on the diagnostic or prognostic utility of SPECT-MPI. The study validates the methods used in determining risk in the AUC algorithm and endorses the widespread application of AUC in men and women.

Impact of insurance carrier, prior authorization, and socioeconomic status on appropriate use of SPECT myocardial perfusion imaging in private community-based office practice.

BACKGROUND: The impact of health insurance carrier and socioeconomic status (SES) on the adherence to appropriate use criteria (AUC) for radionuclide myocardial perfusion imaging (MPI) is unknown. HYPOTHESIS: Health insurance carrier's prior authorization and patient's SES impact adherence to AUC for MPI in a fee-for-service setting. METHODS: We conducted a prospective cohort study of 1511 consecutive patients who underwent outpatient MPI in a multi-site, office-based, fee-for-service setting. The patients were stratified according to the 2009 AUC into appropriate/uncertain appropriateness and inappropriate use groups. Insurance status was categorized as Medicare (does not require prior authorization) vs commercial (requires prior authorization). Socioeconomic status was determined by the median household income in the ZIP code of residence. RESULTS: The proportion of patients with Medicare was 33% vs 67% with commercial insurance. The rate of inappropriate use was higher among patients with commercial insurance vs Medicare (55% vs 24%; P < 0.001); this difference was not significant after adjusting for confounders known to impact AUC determination (odds ratio: 1.06, 95% confidence interval: 0.62-1.82, P = 0.82). The mean annual household income in the residential areas of patients with inappropriate use as compared to those with appropriate/uncertain use was $72 000 ± 21 000 vs $68 000 ± 20 000, respectively (P < 0.001). After adjusting for covariates known to impact AUC determination, SES (top vs bottom quartile income area) was not independently predictive of inappropriate MPI use (odds ratio: 0.9, 95% confidence interval: 0.53-1.52, P = 0.69). CONCLUSIONS: Insurance carriers prior authorization and SES do not seem to play a significant role in determining physicians adherence to AUC for MPI.

Impact of appropriate use on the prognostic value of single-photon emission computed tomography myocardial perfusion imaging.

BACKGROUND: Appropriate use criteria (AUC) have been developed to aid in the optimal use of single-photon emission computed tomography (SPECT)-myocardial perfusion imaging (MPI), a technique that is a mainstay of risk assessment for ischemic heart disease. The impact of appropriate use on the prognostic value of SPECT-MPI is unknown. METHODS AND RESULTS: A prospective cohort study of 1511 consecutive patients undergoing outpatient, community-based SPECT-MPI was conducted. Subjects were stratified on the basis of the 2009 AUC for SPECT-MPI into an appropriate or uncertain appropriateness group and an inappropriate group. Patients were prospectively followed up for 27±10 months for major adverse cardiac events of death, death or myocardial infarction, and cardiac death or myocardial infarction. In the entire cohort, the 167 subjects (11%) with an abnormal scan experienced significantly higher rates of major adverse cardiac events and coronary revascularization than those with normal MPI. Among the 823 subjects (54.5%) whose MPIs were classified as appropriate (779, 51.6%) or uncertain (44, 2.9%), an abnormal scan predicted a multifold increase in the rates of death (9.2% versus 2.6%; hazard ratio, 3.1; P=0.004), death or myocardial infarction (11.8% versus 3.3%; hazard ratio, 3.3; P=0.001), cardiac death or myocardial infarction (6.7% versus 1.7%; hazard ratio, 3.7; P=0.006), and revascularization (24.7% versus 2.7%; hazard ratio, 11.4; P<0.001). Among the 688 subjects (45.5%) with MPI classified as inappropriate, an abnormal MPI failed to predict major adverse cardiac events, although it was associated with a high revascularization rate. Furthermore, appropriate MPI use provided incremental prognostic value beyond myocardial perfusion and ejection fraction data. CONCLUSIONS: When performed for appropriate indications, SPECT-MPI continues to demonstrate high prognostic value. However, inappropriate use lacks effectiveness for risk stratification, further emphasizing the need for optimal patient selection for cardiac testing.

The prognostic value of transient ischemic dilatation with otherwise normal SPECT myocardial perfusion imaging: a cautionary note in patients with diabetes and coronary artery disease.

BACKGROUND: The prognostic implications of transient ischemic dilatation (TID) of the left ventricle with otherwise normal single-photon emission computed tomography myocardial perfusion imaging (MPI) remain controversial. Whether this finding may have prognostic implications only in high-risk populations, such as patients with diabetes or manifest coronary artery disease (CAD), is uncertain. METHODS: We conducted a prospective cohort study of 1,236 consecutive patients with normal (99m)Tc-sestamibi MPI, defined as normal perfusion (summed stress score = 0) and normal left ventricle volume and function. TID was defined as >2 standard deviations above the mean of patients with low likelihood of CAD. RESULTS: The study subjects were followed for 27 ± 9 months. The 76 (6%) patients with TID had a greater rate of cardiac death or myocardial infarction (MI) [4 (5.3%) vs 11 (0.6%), P = .003] independent of covariates [hazard ratio = 6.4, P = .004]. This finding was entirely derived from the subgroup of 294 patients with diabetes or CAD [4 (13.3%) with TID vs 1 (0.4%) without TID, P = .001] independent of covariates. However, TID was not predictive of cardiac death or MI among the 941 patients without diabetes or CAD. Furthermore, TID was not predictive of coronary revascularization. CONCLUSIONS: This study confirms a benign prognosis of TID with otherwise normal MPI in patients without diabetes or CAD, but cautions against extending this conclusion to high-risk individuals, particularly those with diabetes or CAD.

The prognostic value of cardiac SPECT performed at the primary care physician's office.

BACKGROUND: The prognostic value of single-photon emission computed-tomography (SPECT)-myocardial perfusion imaging (MPI) is well documented. However, the utility of SPECT-MPI when performed at a low-volume primary care physician's (PCP's) office is unknown. METHODS: We conducted a prospective cohort study of consecutive patients referred by their PCP to undergo a stress-MPI at the PCP's office using a mobile laboratory. Major adverse cardiovascular events (MACE) of death, myocardial infarction (MI), and coronary revascularization were prospectively tabulated using mail and telephone interviews, chart review, and social security death index. RESULTS: One thousand three hundred ninety subjects [mean age 58 ± 13 years; 44% women] were followed for 27 ± 9 months, with a 99% complete follow-up rate. Subjects with abnormal MPI [174 (12.5%)] had significantly higher rates of all-cause mortality [5.2% vs 1.0%, P < .001], death, or MI [5.7% vs 1.5%, P = .001], and the composite of death, MI, or late revascularization (>60 days post-MPI) [12.6 vs 2.7%, P < .001]. Overall MACE risk was associated with the total perfusion abnormality burden, while the revascularization rate was related to the reversible perfusion abnormality burden. CONCLUSION: Contemporary SPECT-MPI performed in the setting of a PCP's office carries a robust prognostic value, similar to that reported in tertiary or large-volume practice settings.