Publications

BACKGROUND: National trends and costs associated with remote and in-office interrogations of pacemakers and implantable cardioverter-defibrillators (ICDs) have not been previously described.

OBJECTIVE: The purpose of this study was to evaluate utilization and Medicare spending for remote monitoring and in-office interrogations for pacemakers and ICDs.

METHODS: We performed a retrospective cohort study of claims and spending for remote and in-office interrogations of pacemakers and ICDs for Medicare fee-for-service beneficiaries from 2012 to 2015. Aggregate and per-beneficiary claims and spending were calculated for each device type.

RESULTS: Among all patients, 41.9% were female and the mean age was 78.3 years. From 2012 to 2015, remote monitoring utilization increased sharply. Aggregate professional remote monitoring claims for pacemakers increased by 61.3% and for ICDs by 5.6%, with an increase in technical claims (combined for pacemakers and ICDs) of 32.8%. Spending on all remote and in-office interrogations for these devices totaled $160 million per year, with remote costs increasing nearly 25% from $45.4 million in 2012 to $56.7 million in 2015. At the beneficiary level, remote interrogations increased for pacemakers from 0.6 to 0.9 per year, and for ICDs from 1.3 to 1.4 per year, whereas in-office interrogations decreased from 2.8 to 2.7 per year and from 3.0 to 2.9 per year, respectively. Beneficiary-level analysis revealed increased expenditures on remote interrogation offset by decreases in in-office expenditures, with total annual spending decreasing by $2 and $5 per beneficiary, respectively.

CONCLUSION: Remote monitoring utilization increased substantially from 2012 to 2015, whereas annual costs per beneficiary decreased.

While the presence of gender disparities in cardiovascular disease have been described, there is a paucity of data regarding the impact of sex in acute pulmonary embolism (PE). We identified all patients admitted to a tertiary care hospital with acute PE between August 1, 2012 through July 1, 2018. We stratified the presenting characteristics, management, and outcomes between women and men. Of the 2031 patients admitted with acute PE, 1081 (53.2%) were women. Women were more likely to present with dyspnea (59.8% vs 52.0%, p < 0.001) and less likely to present with hemoptysis (1.9% vs 4.0%, p = 0.01). Women were older (63.8 ± 17.4 years vs 62.3 ± 15.0 years, p = 0.04), but had lower rates of myocardial infarction, liver disease, smoking history, and prior DVT. PE severity was similar between women and men (massive: 4.9% vs 3.6%; submassive: 43.9% vs 41.8%; p = 0.19), yet women were more likely to present with normal right ventricular size on a surface echocardiogram (63.2% vs 54.8%, p = 0.01). In unadjusted analyses, women were less likely to survive to discharge (92.4% vs 94.7%, p = 0.04), but after adjustment, there was no sex-based survival difference. There were no sex differences in the PE-related diagnostic studies performed, use of advanced therapies, or short-term outcomes, before and after adjustment (p > 0.05 for all). In this large PE cohort from a tertiary care institution, women had different comorbidity profiles and PE presentations compared with men. Despite these differences, there were no sex disparities in PE management or outcomes.

OBJECTIVE: The aim of this study was to determine sex specific differences in the invasive treatment of symptomatic peripheral arterial occlusive disease (PAOD) between member states participating in the VASCUNET and International Consortium of Vascular Registries.

METHODS: Data on open surgical revascularisation and peripheral vascular intervention (PVI) of symptomatic PAOD from 2010 to 2017 were collected from population based administrative and registry data from 11 countries. Differences in age, sex, indication, and invasive treatment modality were analysed.

RESULTS: Data from 11 countries covering 671 million inhabitants and 1 164 497 hospitalisations (40% women, mean age 72 years, 49% with intermittent claudication, 54% treated with PVI) in Europe (including Russia), North America, Australia, and New Zealand were included. Patient selection and treatment modality varied widely for the proportion of female patients (23% in Portugal and 46% in Sweden), the proportion of patients with claudication (6% in Italy and 69% in Russia), patients' mean age (70 years in the USA and 76 years in Italy), the proportion of octogenarians (8% in Russia and 33% in Sweden), and the proportion of PVI (24% in Russia and 88% in Italy). Numerous differences between females and males were observed in regard to patient age (72 vs. 70 years), the proportion of octogenarians (28% vs. 15%), proportion of patients with claudication (45% vs. 51%), proportion of PVI (57% vs. 51%), and length of hospital stay (7 days vs. 6 days).

CONCLUSION: Remarkable differences regarding the proportion of peripheral vascular interventions, patients with claudication, and octogenarians were seen across countries and sexes. Future studies should address the underlying reasons for this, including the impact of national societal guidelines, reimbursement, and differences in health maintenance.

BACKGROUND: Visual imagery has been shown to improve adherence to health messages but has scarcely been investigated in sun protection campaigns.

OBJECTIVE: To determine the effectiveness of pictorial- and textual-based sun protective messages in a largely Hispanic population.

METHODS: One hundred and forty-five participants received standard of care (SOC) as defined as sun protective counseling and were then randomized to receive either (a) images of sun damage, (b) a textual pamphlet about sun damage, or (c) no further messages. 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: All stimulus groups demonstrated an improvement in perceived effectiveness of sun protective habits (p < 0.05). However, pictorial and textual stimuli were both more effective than SOC in improving intentions to sun protect (p < 0.05), but there was no differential effect between the two.

CONCLUSIONS: Both pictorial and textual stimuli were more effective than SOC in improving intentions to sun protect, but there was no differential effect between the two.

Inferior vena cava filters (IVCF) are associated with complications which may be due to delayed retrieval. Initiation of an automated reminder system may improve retrieval rates and reduce complications. A computerized reminder system, which provides interactive email reminders after implantation while collecting IVCF use data, was implemented. IVCF retrieval was compared before ("reminder not provided" group) and after ("reminder provided" group) implementation. Data regarding implantation, retrieval, and complications were collected. The primary efficacy outcome was retrieval rate, and the primary safety outcome was indwelling complication rate. Secondary outcomes were time to retrieval and a composite adverse outcome defined as IVCF thrombosis, deep venous thrombosis (DVT), pulmonary embolism, and death. A total of 1,070 IVCF insertions were included, 715 in the "reminder not provided" group and 355 in the "reminder provided" group. Patient age (61 vs 64 years, p = 0.95) and gender (42% vs 40% female, p = 0.55) were similar in the "reminder not provided" and "reminder provided" groups, respectively. In the "reminder provided" group, the retrieval rate was higher (148/297 [49.8%] vs 223/715 [31.2%], p = 0.0001), the indwelling complication rate was lower (30/319 [9.4%] vs 115/715 [16.1%], p = 0.005), and the time to retrieval was shorter (112 days vs 146 days, p = 0.02). The composite adverse outcome occurred less frequently in the "reminder provided" group: (85/355 [23.9%] vs 297/715 [41.5%], p = 0.0001). The system was associated with increased odds of IVCF retrieval (odds ratio 2.56; 95% confidence interval: 1.82 to 3.59; p <0.0001) and reduced odds of the composite adverse outcome (odds ratio 0.72; 95% confidence interval: 0.60 to 0.80; p <0.0001). In conclusion, implementing a computerized email reminder system was associated with higher IVCF retrieval rates, fewer indwelling complications, and shorter dwell times.

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.