Publications

IMPORTANCE: Following negative randomized clinical trials, US guidelines downgraded support for routine manual aspiration thrombectomy (AT) during primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction (STEMI). However, some PCI operators continue to endorse a clinical benefit with AT use despite the lack of supportive data.

OBJECTIVE: To examine temporal trends and comparative outcomes of AT use during pPCI for STEMI.

DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of the National Cardiovascular Data Registry (NCDR) CathPCI Registry from July 1, 2009, to June 30, 2016, to assess temporal trends and in-hospital outcomes associated with AT use. To evaluate outcomes through 180 days, a subanalysis was conducted among Centers for Medicare and Medicaid Services-linked patients from July 1, 2009, through December 31, 2014. The comparative effectiveness analysis was performed using instrumental variable analyses to account for treatment selection bias. The instrumental variable was operator's preference to use AT during pPCI. Data were analyzed between February 1, 2017, and April 1, 2018.

EXPOSURES: Aspiration thrombectomy use during pPCI for STEMI.

MAIN OUTCOMES AND MEASURES: Primary outcomes included in-hospital stroke and death. Secondary outcomes included heart failure, stroke, all-cause rehospitalization, and death through 180 days of follow-up.

RESULTS: Among all pPCIs performed (683 584), the mean (SD) age of patients was 61.7 (12.8) years, 489 257 were male (71.6%), and 596 384 were white (87.2%). Among patients undergoing pPCI, AT use increased from 2009 through 2011, with peak use of 13.8%. This was followed by a decline of more than 9%, reaching 4.7% by mid-2016. Overall, AT was used in 10.8% of pPCIs (lowest operator group median, 0%; highest operator group median, 33.8%). After instrumental variable analysis, AT use was associated with no difference in in-hospital death (adjusted absolute risk difference, -0.18%; 95% CI, -0.53% to 0.16%; P = .29) and a small increase in in-hospital stroke (adjusted RD, 0.14%; 95% CI, 0.01%-0.30%; P = .03). Among Centers for Medicare and Medicaid Services-linked patients, AT use was not associated with differences in death, heart failure, stroke, or rehospitalization at 180 days.

CONCLUSIONS AND RELEVANCE: In this large, nationwide analysis, AT use during STEMI pPCI declined by more than 50% since 2011, with use as of mid-2016 at less than 5%. Selective AT use was associated with a small excess risk of in-hospital stroke and no difference in other outcomes through 180 days of follow-up.

This study examines the appropriate use of percutaneous coronary interventions in New York, Michigan, and Florida using Healthcare Cost and Utilization Project state databases.

IMPORTANCE: In a recent meta-analysis of randomized clinical trials, femoropopliteal artery revascularization with paclitaxel drug-coated devices was associated with increased long-term all-cause mortality compared with non-drug-coated devices. However, to our knowledge, these findings have not been replicated in other data sources and may be subject to confounding from missing data associated with patient withdrawal and loss to follow-up.

OBJECTIVE: To evaluate differences in all-cause mortality between patients who were treated with drug-coated devices vs non-drug-coated devices for femoropopliteal artery revascularization.

DESIGN, SETTING, AND PARTICIPANTS: This nationwide, multicenter retrospective cohort study included 16 560 Centers for Medicare and Medicaid Services beneficiaries who were admitted for femoropopliteal artery revascularization from January 1, 2016, to December 31, 2016. All-cause mortality was analyzed through September 30, 2017.

EXPOSURES: Drug-coated devices (drug-eluting stent [DES] or drug-coated balloon [DCB]) compared with non-drug-coated devices (bare metal stent or uncoated percutaneous transluminal angioplasty balloon).

MAIN OUTCOMES AND MEASURES: The primary outcome was all-cause mortality analyzed through the end of follow-up.

RESULTS: Among 16 560 patients treated at 1883 hospitals, the mean (SD) age was 72.9 (11) years, 7734 (46.7%) were men, 12 232 (73.9%) were white, 8222 (49.7%) currently or had previously used tobacco, 9817 (59.3%) had diabetes, and 8450 (51.0%) had critical limb ischemia (CLI). Drug-coated devices were used in 5989 participants (36.2%). The median follow-up was 389 days (interquartile range, 277-508 days). Among all patients, treatment with drug-coated devices was associated with a lower cumulative incidence of all-cause mortality compared with treatment with non-drug-coated devices through 600 days postprocedure (32.5% vs 34.3%, respectively; log-rank P = .007). Similar survival trends were observed when treatment was stratified by using a DCB alone or DES with or without DCB. After multivariable adjustment, drug-coated devices were not associated with a difference in all-cause mortality compared with non-drug-coated devices (hazard ratio [HR], 0.97; 95% CI, 0.91-1.04; P = .43). These findings were consistent among those with CLI (HR, 0.93; 95% CI, 0.85-1.01; P = .09) or without CLI (HR, 0.94; 95% CI, 0.85-1.03; P = .20), and for those treated with DCB alone (HR, 0.94; 95% CI, 0.86-1.03; P = .17) or DES with or without DCB (HR, 0.97; 95% CI, 0.89-1.06; P = .48).

CONCLUSIONS AND RELEVANCE: In this large nationwide analysis of Centers for Medicare and Medicaid Services beneficiaries, there was no evidence of increased all-cause mortality following femoropopliteal artery revascularization with drug-coated devices compared with non-drug-coated devices.

Since the implementation of the Hospital Readmissions Reduction Program (HRRP), readmissions have declined for Medicare patients with conditions targeted by the policy (acute myocardial infarction, heart failure, and pneumonia). To understand whether HRRP implementation was associated with a readmission decline for patients across all insurance types (Medicare, Medicaid, and private), we conducted a difference-in-differences analysis using information from the Nationwide Readmissions Database. We compared how quarterly readmissions for target conditions changed before (2010-12) and after (2012-14) HRRP implementation, using nontarget conditions as the control. Our results demonstrate that readmissions declined at a significantly faster rate after HRRP implementation not just for Medicare patients but also for those with Medicaid, both in the aggregate and for individual target conditions. However, composite Medicaid readmission rates remained higher than those for Medicare. Throughout the study period privately insured patients had the lowest aggregate readmission rates, which declined at a similar rate compared to nontarget conditions. The HRRP was associated with nationwide readmission reductions beyond the Medicare patients originally targeted by the policy. Further research is needed to understand the specific mechanisms by which hospitals have achieved reductions in readmissions.

Objective: We assessed willingness-to-pay (WTP) and time trade-off (TTO) as methods to quantify the disease burden of benign hyperpigmentation. Design: This was a cross-sectional pilot study that included 85 adults. A paper survey was used to collect demographic and health utility information; an accompanying dermatological exam assessed disease severity. Setting: This was a single-site study performed at an urban dermatology clinic. Participants: Adults 18 years of age or older who spoke English, Spanish, or Portuguese were included. Measurements: Utility measures included WTP, TTO, and time spent concealing the condition; correlation with quality of life was also assessed. Results: Mean WTP for 25-percent improvement (WTP25) of the skin condition was $38.95; for a 50-percent improvement (WTP50), $83.18. Participants were willing to give up 1.4 hours per day to receive a therapy that would completely cure their condition. The average proportion of monthly income that participants were willing to spend on a therapy that could cure their condition was 13.3 percent. Daily concealment time was, on average, 20.8 minutes, which correlated with a worsened quality of life. Conclusion: Disease burden was high, overall, for benign hyperpigmentation conditions. Health utilities offer a patient-centered method of assessing impact on quality of life.

OBJECTIVES: This study sought to examine depression prevalence among chronic total occlusion (CTO) patients and compared symptom improvement among depressed and nondepressed patients after percutaneous coronary intervention (PCI).

BACKGROUND: Depression in cardiovascular patients is common, but its prevalence among CTO patients and its association with PCI response is understudied.

METHODS: Among 811 patients from the OPEN-CTO (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures) registry, we evaluated change in health status between baseline and 1-year post-PCI, as measured by the Seattle Angina Questionnaire (SAQ) and the Rose Dyspnea Score. Depression was defined using the Personal Health Questionnaire-8. The independent association between health status and depression following PCI was assessed using multivariable regression.

RESULTS: Among the 811 patients, 190 (23%) screened positive for major depression, of whom 6.3% were on antidepressant therapy at intervention. Depressed patients experienced more baseline angina, but by 1-year post-PCI they experienced greater improvements than nondepressed patients (change in SAQ Summary: 31.4 ± 22.4 vs. 24.2 ± 20.0; p < 0.001). After adjustment, baseline depressed patients had more improvement in health status (adjusted difference in SAQ Summary improvement, depressed vs. nondepressed: 5.48 ± 1.81; p = 0.003).

CONCLUSIONS: Depression is common among CTO PCI patients, but few were treated with antidepressants at baseline. Depressed patients had more severe baseline angina and significant improvement in health status after PCI. (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion [OPEN-CTO]; NCT02026466).

BACKGROUND: The cost-effectiveness of newer drug-eluting stents (DES) such as biodegradable-polymer or polymer-free stents with shorter dual antiplatelet therapy (DAPT) duration is unknown. We evaluated the cost-effectiveness of treatment with newer DES that may allow for shorter DAPT duration.

PATIENTS AND METHODS: We performed a cost-effectiveness analysis of treatment with newer DES platforms followed by 1 or 3 months of DAPT compared with standard second-generation DES followed by 6 or 12 months of DAPT in patients with stable coronary disease. A Markov model simulated distinct health states over a lifetime. Probabilistic sensitivity analysis and one-way sensitivity analyses were performed. A high-risk bleeding scenario was also evaluated.

RESULTS: Among patients with typical bleeding risk, second-generation DES and 6 months of DAPT was less expensive and resulted in marginally higher quality-adjusted life years compared with other strategies. A newer DES platform and 3 months of DAPT was preferred when the risk of fatal bleeding was two times greater than baseline, or when bleeding increased long-term mortality by a factor of 1.5. In a probabilistic sensitivity analysis, second-generation DES and 6 months of DAPT was preferred in 58% of iterations, whereas in a high-risk bleeding patient scenario, a newer DES and 3 months of DAPT was preferred in 52% of iterations.

CONCLUSION: A DES that allows 3 months of DAPT without increasing stent-related events is likely to be cost-effective among patients at elevated risk of bleeding, but not in patients with average bleeding risk.

BACKGROUND: Appearance-based messages have shown promise in improving sun protection habits among Caucasians but have scarcely been investigated in Hispanic populations.

OBJECTIVE: To compare the effectiveness of appearance-based vs health-based messages in an ethnic patient population, where hyperpigmentation disorders are prevalent and often cosmetically concerning.

METHODS: One hundred thirty-seven patients were randomized to receive images of (a) skin cancer, (b) hyperpigmentation, or (c) wrinkles. Analysis of variance tests for repeated measures were used to estimate the effects of the different stimuli on participants' knowledge and intention to sun protect.

RESULTS: Appearance-based interventions were more effective in improving intentions to sun protect among both Hispanics and non-Hispanic Whites (P < 0.05). They were furthermore more effective among younger patient populations (≤40 years old) and patients who thought that a tanned appearance is attractive (P < 0.05).

CONCLUSIONS: Appearance-based photos of sun damage were more effective than health-based messages among Hispanics, younger patient populations, and those who find tanned appearances to be attractive.