Publications

PURPOSE OF REVIEW: Paclitaxel-based endovascular devices have become the standard of care in symptomatic, medication-refractory peripheral artery disease (PAD) and in critical limb ischemia (CLI). This review examines the data on the efficacy and safety of these devices relative to standard balloon angioplasty (PTA) and bare metal stents (BMS).

RECENT FINDINGS: Randomized controlled trials (RCTs) have found that peripheral devices coated with paclitaxel result in superior patency rates and decreased target lesion revascularization (TLR) compared with non-drug-coated devices. Recently, a meta-analysis of randomized controlled trials unexpectedly reported an increase in mortality in patients treated with paclitaxel-coated devices (PCDs), resulting in the pausing of ongoing trials and a warning of safety from the FDA. Observational data that has been published since this time has not supported this safety concern. PAD is a common disease that severely impacts quality and length of life. PCDs are a promising therapy for patients with PAD, offering a more effective and durable intervention when compared with traditional PTA/BMS. A meta-analysis of RCTs identified a signal of harm with these devices which has now been replicated by the FDA. However, there is significant missing data from the trials analyzed by the meta-analysis and FDA, no plausible mechanism linking paclitaxel to death, and no correlation between paclitaxel dose and mortality. Analyses in observational data have found no safety signal. An FDA panel evaluating the validity of this late-mortality signal recently adjourned, emphasizing that the available data is incomplete. PCDs will remain on the market, and an active discussion is underway for developing an approach for improved post-market surveillance, device-labeling, and cause of death adjudication.

BACKGROUND: Advances in chronic total occlusion percutaneous coronary intervention (CTO PCI) techniques have led to increased procedural success rates among operators. While utilization of CTO PCI has disseminated widely, the learning curve for new operators has not been well-defined.

METHODS: Between July 2009 and December 2015, 93 875 CTO PCI cases were extracted from the CathPCI Registry. We delineated a cohort of new CTO operators performing <10 CTO PCI cases per given year. In-hospital outcomes for subsequent CTO PCIs were stratified by the number of prior cases accrued by each operator. Multivariable regression models were used to estimate differences in outcomes with increasing experience. The primary outcome was major adverse cardiovascular events defined as the composite of death, myocardial infarction, stroke, tamponade, or urgent coronary artery bypass grafting.

RESULTS: Among 70 916 cases performed by 7251 new operators, procedure success rate was 61.4% and major adverse cardiovascular event rate was 4.2%. Meanwhile, the rate of major bleeding was 4.0%, myocardial infarction 2.0%, mortality 0.6%, tamponade 0.3%, and renal failure 0.2%. Adjusted regression models demonstrated piecewise linear improvements in guidewire crossing, stent placement, and procedure success with accrued volume, albeit with increased contrast use, fluoroscopy time, and bleeding. Major adverse cardiovascular event rates were stable beyond the 12th case (odds ratio per 5 case increase 1.00; 95% CI, 0.98-1.03, P=0.7980).

CONCLUSIONS: Among a large number of new CTO PCI operators in the United States, there exists an experiential learning curve for procedural success. However, there were higher rates of bleeding despite case experience, while major adverse cardiovascular events remained relatively unchanged after initiation.

OBJECTIVE: To evaluate how patients' primary spoken language influences the understanding of their disorder and their subsequent sun-related behaviors.

METHODS: This was a cross-sectional study conducted between February 2015 and July 2016 in two outpatient dermatology clinics among 419 adults with a sun-exacerbated dermatosis. The primary outcome was a successful match between the patient-reported diagnosis on a survey and the dermatologist-determined diagnosis.

RESULTS: Of participants, 42% were native English speakers, and 68% did not know their diagnosis. Fewer non-native English speakers identified one risk factor for their condition (46% versus 54%, p < 0.01). A greater number of non-native English speakers were less familiar with medical terminology. Native English speakers were 2.5 times more likely to know their diagnosis compared to non-native speakers (adjusted odds (aOR) 2.5, 95% confidence interval, 1.32 to 4.5; p = 0.005). Additional factors associated with higher odds of knowing the diagnosis included: Higher education, sunscreen use, female gender, symptoms for 1-5 years, and diagnosis of melasma and postinflammatory hyperpigmentation (PIH).

CONCLUSIONS: Knowledge of the diagnosis and understanding of factors that may influence skin disease may promote conscious sun behavior. Patients who knew that their diagnosis was sun-exacerbated had higher odds of wearing sunscreen.

Lower extremity peripheral artery disease (PAD) and cerebrovascular disease (CeVD) are prevalent conditions in the United States, and both are associated with significant morbidity (eg, stroke, myocardial infarction, and limb loss) and increased mortality. With a growth in invasive procedures for PAD and CeVD, this demands a more clear responsibility and introduces an opportunity to study how patients are treated and evaluate associated outcomes. The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry is a prospective, independent collection of data elements from individual patients at participating centers, and it is a natural extension of the already robust NCDR infrastructure. As of September 20, 2018, data have been collected on 45,316 lower extremity PVIs, 12,417 carotid artery stenting procedures, and 11,027 carotid endarterectomy procedures at 208 centers in the United States. The purpose of the present report is to describe the patient and procedural characteristics of the overall cohort and the methods used to design and implement the registry. In collecting these data, ACC and ACC PVI Registry have the opportunity to play a pivotal role in scientific evidence generation, medical device surveillance, and creation of best practices for PVI and carotid artery revascularization.

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.

OBJECTIVE: To investigate whether hospital readmission after admission for heart failure (HF), myocardial infarction (MI), and pneumonia varies by season.

DATA SOURCES: All patients in 2005-2009 Healthcare Cost and Utilization Project State Inpatient Databases for New York and California hospitalized for HF, MI, or pneumonia.

STUDY DESIGN: The relationship between discharge season and unplanned readmission within 30 days was evaluated using multivariate modified Poisson regression.

PRINCIPAL FINDINGS: Cohorts included 869,512 patients with HF, 448,945 patients with MI, and 813,593 patients with pneumonia. While admissions varied widely by season, readmission rates only ranged from 25.0 percent (spring) to 25.6 percent (winter) for HF (p > .05), 18.9 percent (summer) to 20.0 percent (winter) for MI (p < .001), and 19.4 percent (spring) to 20.3 percent (summer) for pneumonia (p < .001). In adjusted models, in New York, there was lower readmission in spring and fall (RR: 0.98, 95% CI: 0.96-0.99 for both) after admission for HF and higher readmission in spring (RR: 1.04, 95% CI: 1.01-1.07) after MI. In California, there was lower readmission in spring and winter (RR: 0.95, 95% CI: 0.93-0.96 and RR: 0.96, 95% CI: 0.94-0.98, respectively) after pneumonia.

CONCLUSIONS: Given marked seasonality in incidence and mortality of HF, MI, and pneumonia, the modest seasonality in readmissions suggests that readmissions may be more related to non-seasonally dependent factors than to the seasonal nature of these diseases.

Patients discharged on oral anticoagulant (OAC) therapy after percutaneous coronary intervention (PCI) represent a complex population and are at higher risk of early readmission. The reasons and predictors of early readmission in this group have not been well characterized. We identified patients in an integrated health care system who underwent PCI between 2009 and 2014 and were readmitted within 30 days within this health care system. Of the 9,357 patients surviving to discharge after the index PCI, 692 were readmitted within 30 days (7.4%). At the time of readmission, 143 had been discharged from the index PCI hospitalization on OACs (96.5% on warfarin) and 549 had not been discharged on OACs, with readmission rates of 12.9% and 6.7%, respectively (p<0.01). The most common reason for readmission among all patients was chest pain syndromes (21.7% on OACs, 34.4% not on OACs). However, bleeding represented the next most frequent cause of readmission among patients on OACs (14.0% on OACs vs 6.0% not on OACs, p<0.01). Among patients on OAC therapy, peripheral arterial disease (odds ratio [OR] 1.66, 95% confidence interval [CI] 1.07-2.57, p = 0.02) and nonelective PCI (OR 1.91, 95% CI 1.17-3.12, p<0.01) were found to be independent predictors of 30-day readmission. During rehospitalization, compared to patients not on OACs, patients on OACs suffered a higher unadjusted rate of mortality (6.3% vs 1.8%, p<0.01) and a longer length of stay (6.4 ± 7.1 days vs 4.9 ± 6.8 days, p = 0.02). In conclusion, patients discharged on OAC therapy after PCI are commonly readmitted, with bleeding representing a major reason. These readmissions are associated with high mortality and longer lengths of stay. Interventions targeted towards optimizing discharge planning for these complex patients are needed to potentially reduce readmissions.

BACKGROUND: Chemical peels have shown efficacy in the treatment of acne, photoaging, and pigmentary dyschromias; however, studies evaluating side effects, particularly in patients with skin of color, are limited.

OBJECTIVE: We sought to determine the frequency of side effects and complications associated with superficial chemical peels in patients with skin types III-VI.

METHODS: A 5-year single center retrospective analysis was performed.

RESULTS: Of 473 chemical peel treatments included in this study, 18 (3.8%) were associated with short-term (≤2 weeks) or long-term (>2 weeks) complications. The most frequent complications were crusting (2.3%), postinflammatory hyperpigmentation (1.9%), and erythema (1.9%). All side effects resolved within 8 months of treatment and were located on the face. When stratified by season, side effects were noted to be less common during the winter. In the adjusted model, Fitzpatrick skin type VI was associated with a higher odds of side effects (odds ratio 5.14, 95% confidence interval 1.21-21.8; P = .0118).

LIMITATIONS: Single center retrospective design.

CONCLUSION: In this study, superficial chemical peels performed on patients with skin types III-VI had a relatively low complication rate, and skin type VI had higher odds of experiencing an adverse event. Side effects were noted to be less frequent during the winter months.