Gender Issues in Italian Catheterization Laboratories: The Gender-CATH Study.

Background Women represent an increasing percentage of interventional cardiologists in Italy compared with other countries. However, gaps exist in understanding and adapting to the impact of these changing demographics. Methods and Results We performed a national survey to analyze demographics, gender-based professional difference, needs in terms of catheterization laboratory (Cath-Lab) abstention, and radiation safety issues in Italian Cath-Lab settings. A survey supported by the Italian Society of Interventional Cardiology (Società Italiana di Cardiologia Interventistica-Gruppo Italiano di Studi Emodinamici SICI-GISE) was mailed to all SICI-GISE members. Categorical data were compared using the χ2 test. P<0.05 was considered significant. There were 326 respondents: 20.2% were <35 years old, and 64.4% had >10 years of Cath-Lab experience. Notably, 26.4% were women. Workload was not gender-influenced (women performed "on-call" duty 69.8% versus men 68.3%; P=0.97). Women were more frequently unmarried (22.1% women versus 8.7% men; P=0.002) and childless (43.9% versus 56.1%; P<0.001). Interestingly, 69.8% of women versus 44.6% of men (P<0.001) argued that pregnancy/breastfeeding negatively impacts professional skill development and career advancement. For Cath-Lab abstention, 38.9% and 69.6% of respondents considered it useful to perform percutaneous coronary intervention robotic simulations and "refresh-skill" sessions while they were absent or on return to work, respectively, without gender differences. Overall, 80% of respondents described current radioprotection counseling efforts as inadequate and not gender specific. Finally, 26.7% faced some type of job discrimination, a significantly higher proportion of whom were women. Conclusions Several gender-based differences exist or are perceived to exist among interventional cardiologists in Italian Cath-Labs. Joint strategies addressing Cath-Lab abstention and radiation exposure education should be developed to promote gender equity in interventional cardiologists.

Tratamento ortodôntico em paciente com queimadura facial ­ relato de caso / Orthodontic treatment in patient with facial burn injury ­ case report

Resumo Inúmeras variáveis são consideradas em uma oclusão normal, uma delas é a homeostasia da musculatura facial e sua harmonia com os ossos e dentes. Diversos fatores podem levar a alterações na funcionalidade muscular. Um exemplo é a queimadura facial, na qual é comum a formação de cicatrizes hipertróficas que provocam disfunção nas estruturas musculares e impactam no crescimento facial e no desenvolvimento da dentição. Paciente K.R.S, sexo feminino, 15 anos, procurou tratamento no Centro de Atenção e Pesquisa de Anomalias Craniofaciais (CEAPAC) com queixa de "dentes tortos". Durante anamnese relatou que quando criança sofreu um acidente doméstico que acarretou queimaduras na face e parte do corpo. A paciente era portadora de má oclusão de Classe I de Angle e lingualização dos incisivos superiores e inferiores. Observou-se atresia das arcadas dentárias e apinhamento moderado. Realizou-se a expansão rápida da maxila e expansão dentária inferior com a placa lábio ativa, seguida de alinhamento e nivelamento dos dentes com aparelho fixo. Na fase de contenção utilizaram-se placas de Hawley (superior e inferior), além de uma contenção fixa inferior. Os tratamentos de expansão das arcadas e alinhamento se mostraram viáveis e previsíveis. Entretanto a estabilidade tem prognóstico duvidoso, o que levou os autores a indicarem o uso das contenções por tempo indeterminado.(AU)

Abstract Numerous variables are considered in a normal occlusion, one of those is the homeostasis of the facial musculature and its harmony with bones and teeth. Several factors can lead to change in muscle functionality. An example is the facial burn injury in which it is common formation of hypertrophic scars that cause muscle structures dysfunction and impact on facial growth and dentition development. Patient K.R.S, 15-years-old, female, sought treatment at the Center for Attention and Research of Craniofacial Anomalies (CEAPAC) complaining of "crooked teeth". She reported during anamnesis that when she was a child, she suffered a domestic accident which caused facial, and body burn injury. The patient had Angle Class I malocclusion and upper and lower incisor lingualization. Dental arch atresia and moderate crowding were observed. Rapid maxillary expansion and lower dental expansion were performed with the lip bumper, followed by teeth alignment and leveling with a fixed appliance. In the retainment phase, Hawley plates (upper and lower) were used in addition to a fixed lower retainer. The treatment of arch expansion and alignment proved to be viable and predictable, however, the stability has a dubious prognosis, which led the authors to indicate the use of retainers indefinitely. (AU)

Impact of Diabetes Mellitus in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents.

BACKGROUND: Data examining the impact of diabetes mellitus (DM) on ischemic risk after percutaneous coronary intervention in women are limited as most clinical trial participants are male. We evaluated (1) the impact of DM on ischemic outcomes in women undergoing drug-eluting stent (DES) implantation and (2) whether the outcomes of new- versus early-generation DES vary by DM status. METHODS AND RESULTS: We pooled patient-level data of 10 448 women undergoing percutaneous coronary intervention with DES from 26 randomized trials. Baseline characteristics and 3-year clinical outcomes were stratified according to DM status (noninsulin-dependent and insulin-dependent) and DES generation. The primary end point was the composite of all-cause death or myocardial infarction. Secondary end points were definite or probable stent thrombosis and target lesion revascularization. Compared with women without DM (n=7154, 68.5%), adjusted risks (adjusted hazard ratios [95% CI]) for death or myocardial infarction among women with noninsulin-dependent DM (n=2241, 21.4%) and insulin-dependent DM (n=1053, 10.1%) were 1.30 (1.11-1.53) and 1.71 (1.41-2.07), respectively ( Ptrend<0.001). Similar trends were observed for def/prob stent thrombosis and target lesion revascularization. Compared with early-generation DES, use of newer-generation DES was associated with significant reductions in death or myocardial infarction in the absence of DM whereas differences were nonsignificant in the presence of DM, with similar findings for def/prob stent thrombosis and target lesion revascularization. CONCLUSIONS: The presence of DM is associated with substantial, graded, and durable risks for ischemic events among women undergoing percutaneous coronary intervention with DES. The safety and efficacy profile of newer-generation DES is preserved among women without DM, while benefits are nonsignificant among women with DM.

Effects of Body Mass Index on Clinical Outcomes in Female Patients Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents: Results From a Patient-Level Pooled Analysis of Randomized Controlled Trials.

OBJECTIVES: This study sought to investigate the effect of different body mass index (BMI) categories on clinical outcomes in female patients treated with percutaneous coronary intervention (PCI) and drug-eluting stents. BACKGROUND: Patients with higher BMI might, paradoxically, have better long-term clinical outcomes after acute coronary syndrome treated with PCI. METHODS: We pooled patient-level data for female participants from 26 randomized trials on PCI with drug-eluting stents. Patients were stratified into underweight (BMI, <18.5), normoweight (BMI, 18.5 to 24.9), overweight (BMI, 25 to 29.9), obese (BMI, 30 to 34.9), or morbidly obese (BMI, ≥35). The primary endpoint was major adverse cardiac events, a composite of death, myocardial infarction, or target lesion revascularization at 3 years. RESULTS: Among 11,557 female patients included in the pooled database, 9,420 were treated with a drug-eluting stent and had BMI data available. Patients with higher BMI were significantly younger and with more cardiovascular risk factors. Only 139 patients were underweight and had significantly higher adjusted rates of cardiac mortality and all-cause mortality than the rest of the population (hazard ratio: 2.20 [1.31 to 3.71] compared with normoweight). There was a significantly lower frequency of unadjusted 3-year all-cause mortality in overweight, obese, and severely obese patients compared with normoweight. However, following multivariable analysis, a trend toward increased risk of death in severely obese patients was observed, describing an inverse "J"-shaped relation between BMI and 3-year mortality. Conversely, the relationship between BMI and other outcomes, such as major adverse cardiac events, was flat for normoweight and higher BMI. CONCLUSIONS: The risk of 3-year adjusted cardiac events did not differ across BMI groups, whereas the risk of all-cause mortality compared with normoweight was significantly higher in underweight patients and lower in overweight patients with a trend toward increased risk in the severely obese population.

Correlates and Impact of Coronary Artery Calcifications in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents: From the Women in Innovation and Drug-Eluting Stents (WIN-DES) Collaboration.

OBJECTIVES: The aim of this study was to investigate the clinical correlates and prognostic impact of coronary artery calcification (CAC) in women undergoing percutaneous coronary intervention with drug-eluting stents (DES). BACKGROUND: The clinical correlates and the prognostic significance of CAC in women undergoing percutaneous coronary intervention with DES remain unclear. METHODS: Patient-level data from female participants in 26 randomized trials of DES were pooled. Study population was categorized according to the presence of moderate or severe versus mild or no target lesion CAC, assessed through coronary angiography. Co-primary endpoints of interest were the composite of death, myocardial infarction (MI), or target lesion revascularization and death, MI, or stent thrombosis at 3-year follow-up. RESULTS: Among 11,557 women included in the pooled dataset, CAC status was available in 6,371 women. Of these, 1,622 (25.5%) had moderate or severe CAC. In fully adjusted models, independent correlates of CAC were age, hypertension, hypercholesterolemia, smoking, previous coronary artery bypass graft surgery, and worse left ventricular and renal function. At 3 years, women with CAC were at higher risk for death, MI, or target lesion revascularization (18.2% vs. 13.1%; adjusted hazard ratio: 1.56; 95% confidence interval: 1.33 to 1.84; p < 0.0001) and death, MI, or stent thrombosis (12.7% vs. 8.6%; adjusted hazard ratio: 1.48; 95% confidence interval: 1.21 to 1.80; p = 0.0001). The adverse effect of CAC on ischemic outcomes appeared to be consistent across clinical and angiographic subsets of women, including new-generation DES. CONCLUSIONS: Women undergoing PCI of calcified lesions tend to have worse clinical profile and remain at increased ischemic risk, irrespective of new-generation DES.

Safety and Efficacy of New-Generation Drug-Eluting Stents in Women Undergoing Complex Percutaneous Coronary Artery Revascularization: From the WIN-DES Collaborative Patient-Level Pooled Analysis.

OBJECTIVES: The purpose of this study was to investigate the safety and efficacy of new-generation drug-eluting stents (DES) versus early-generation DES in women undergoing complex percutaneous coronary intervention (CPCI). BACKGROUND: Whether the benefits of new-generation DES are preserved in women undergoing complex percutaneous revascularization is unknown. METHODS: We pooled patient-level data from women enrolled in 26 randomized trials of DES. Study population was categorized according to the presence or absence of CPCI, which was defined as the composite of total stent length >30 mm, ≥2 stents implanted, ≥2 lesions treated, or bifurcation lesion as target vessel. The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. RESULTS: Of 10,241 women included in the pooled database, 4,629 (45%) underwent CPCI. Compared with non-CPCI, women who underwent CPCI had a higher 3-year risk of MACE (adjusted hazard ratio [HR]: 1.63; 95% confidence interval [CI]: 1.45 to 1.83; p < 0.0001). In women who underwent CPCI, use of new-generation DES was associated with significantly lower 3-year risk of MACE (adjusted HR: 0.81; 95% CI: 0.68 to 0.96), target lesion revascularization (adjusted HR: 0.74; 95% CI: 0.57 to 0.95), and definite or probable stent thrombosis (ST) (adjusted HR: 0.50; 95% CI: 0.30 to 0.83). The benefit of new-generation DES on efficacy and safety outcomes was uniform between CPCI and non-CPCI groups, without evidence of interaction. By landmark analysis, new-generation DES were associated with low rates (≤0.4%) of very-late ST irrespective of procedural complexity. CONCLUSIONS: Women undergoing CPCI remain at higher risk of adverse events. The long-term ischemic benefits of new-generation DES platforms are uniform among complex and non-complex percutaneous revascularization procedures in women.

Comparisons of the uptake and in-hospital outcomes associated with second-generation drug-eluting stents between men and women: results from the CathPCI Registry.

OBJECTIVES: We sought to examine trends in use and outcomes of second-generation drug-eluting stents (DES) across sexes in a contemporary percutaneous coronary intervention (PCI) cohort. BACKGROUND: Sparse female enrollment in trials comparing first-generation versus second-generation DES may influence clinical decision making at the time of PCI. METHODS: We studied patients undergoing PCI with DES enrolled in the CathPCI Registry between July 2009 and March 2013. We compared the prevalence of second-generation DES use by sex over time. Outcomes included procedural success, post-PCI bleeding, and vascular complications. Associations between sex and DES type on outcomes were assessed using logistic regression with formal interaction tests. RESULTS: Compared with men (n=1 129 122; 67.7%), women (n=538 835; 32.3%) were older, with a higher prevalence of diabetes mellitus, peripheral vascular, and chronic kidney disease. Although use of second-generation DES increased among both men and women over time, use was higher among men in the first 1.5 years, with no differences thereafter. There were no differences in procedural success, bleeding, or vascular complications across sexes between first-generation and second-generation DES. CONCLUSION: Uptake of second-generation DES increased over time in women, with comparable in-hospital benefits as first-generation DES across sexes.

Safety and Efficacy of New-Generation Drug-Eluting Stents in Women at High Risk for Atherothrombosis: From the Women in Innovation and Drug-Eluting Stents Collaborative Patient-Level Pooled Analysis.

BACKGROUND: The safety and efficacy of new-generation drug-eluting stents (DES) in women with multiple atherothrombotic risk (ATR) factors is unclear. METHODS AND RESULTS: We pooled patient-level data for women enrolled in 26 randomized trials. Study population was categorized based on the presence or absence of high ATR, which was defined as having history of diabetes mellitus, prior percutaneous or surgical coronary revascularization, or prior myocardial infarction. The primary end point was major adverse cardiovascular events defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. Out of 10,449 women included in the pooled database, 5333 (51%) were at high ATR. Compared with women not at high ATR, those at high ATR had significantly higher risk of major adverse cardiovascular events (15.8% versus 10.6%; adjusted hazard ratio: 1.53; 95% confidence interval: 1.34-1.75; P=0.006) and all-cause mortality. In high-ATR risk women, the use of new-generation DES was associated with significantly lower risk of 3-year major adverse cardiovascular events (adjusted hazard ratio: 0.69; 95% confidence interval: 0.52-0.92) compared with early-generation DES. The benefit of new-generation DES on major adverse cardiovascular events was uniform between high-ATR and non-high-ATR women, without evidence of interaction (Pinteraction=0.14). At landmark analysis, in high-ATR women, stent thrombosis rates were comparable between DES generations in the first year, whereas between 1 and 3 years, stent thrombosis risk was lower with new-generation devices. CONCLUSIONS: Use of new-generation DES even in women at high ATR is associated with a benefit consistent over 3 years of follow-up and a substantial improvement in very-late thrombotic safety.

Effect of Chronic Kidney Disease in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents: A Patient-Level Pooled Analysis of Randomized Controlled Trials.

OBJECTIVES: This study sought to evaluate: 1) the effect of impaired renal function on long-term clinical outcomes in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES); and 2) the safety and efficacy of new-generation compared with early-generation DES in women with chronic kidney disease (CKD). BACKGROUND: The prevalence and effect of CKD in women undergoing PCI with DES is unclear. METHODS: We pooled patient-level data for women enrolled in 26 randomized trials. The study population was categorized by creatinine clearance (CrCl) <45 ml/min, 45 to 59 ml/min, and ≥60 ml/min. The primary endpoint was the 3-year rate of major adverse cardiovascular events (MACE). Participants for whom baseline creatinine was missing were excluded from the analysis. RESULTS: Of 4,217 women included in the pooled cohort treated with DES and for whom serum creatinine was available, 603 (14%) had a CrCl <45 ml/min, 811 (19%) had a CrCl 45 to 59 ml/min, and 2,803 (66%) had a CrCl ≥60 ml/min. A significant stepwise gradient in risk for MACE was observed with worsening renal function (26.6% vs. 15.8% vs. 12.9%; p < 0.01). Following multivariable adjustment, CrCl <45 ml/min was independently associated with a higher risk of MACE (adjusted hazard ratio: 1.56; 95% confidence interval: 1.23 to 1.98) and all-cause mortality (adjusted hazard ratio: 2.67; 95% confidence interval: 1.85 to 3.85). Compared with older-generation DES, the use of newer-generation DES was associated with a reduction in the risk of cardiac death, myocardial infarction, or stent thrombosis in women with CKD. The effect of new-generation DES on outcomes was uniform, between women with or without CKD, without evidence of interaction. CONCLUSIONS: Among women undergoing PCI with DES, CKD is a common comorbidity associated with a strong and independent risk for MACE that is durable over 3 years. The benefits of newer-generation DES are uniform in women with or without CKD.

Women in interventional cardiology: Update in percutaneous coronary intervention practice patterns and outcomes of female operators from the National Cardiovascular Data Registry®.

OBJECTIVES: To examine the practice patterns and outcomes of percutaneous coronary intervention (PCI) procedures performed by female interventional cardiologists in the United States (U.S.). BACKGROUND: Little is known about the prevalence, volume, case mix, and outcomes of PCI procedures performed by female interventional cardiologists. METHODS: Using data from the National Cardiovascular Data Registry(®) , we performed a retrospective study of 2,465,685 PCI procedures performed at 1,431 U.S. hospitals between July 1, 2009 and June 30, 2013. Interventionalist sex was ascertained from the National Provider Identifier number of each operator. RESULTS: Women accounted for only 4% (412/9,179) of interventional cardiologists in the U.S., and performed 3% (n = 70,009) of all PCI procedures during the time period studied. Forty-one percent of female interventionalists operated at an institution with no other female operators. Female interventionalists performed a median of 48 PCI procedures per year (interquartile range: 22-87). Of the cases performed by female interventionalists, 77% were performed on patients with acute coronary syndrome, 3% on patients with cardiogenic shock, and 16% on call. In-hospital mortality was low (1.8%), and was not significantly different between female operators with high (≥50 cases/year) versus low (1.95% vs. 1.75%, unadjusted P = 0.12, adjusted OR: 1.03, 95% CI: 0.84-1.27) annual procedure volume. CONCLUSIONS: Female interventional cardiologists remain uncommon in contemporary U.S. practice. Performing only a very small proportion of PCI cases, female interventionalists are often low-volume operators, yet no significant differences in patient mortality were observed in low- versus high-volume operators.

Impact of Clinical Presentation (Stable Angina Pectoris vs Unstable Angina Pectoris or Non-ST-Elevation Myocardial Infarction vs ST-Elevation Myocardial Infarction) on Long-Term Outcomes in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents.

The long-term risk associated with different coronary artery disease (CAD) presentations in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is poorly characterized. We pooled patient-level data for women enrolled in 26 randomized clinical trials. Of 11,577 women included in the pooled database, 10,133 with known clinical presentation received a DES. Of them, 5,760 (57%) had stable angina pectoris (SAP), 3,594 (35%) had unstable angina pectoris (UAP) or non-ST-segment-elevation myocardial infarction (NSTEMI), and 779 (8%) had ST-segment-elevation myocardial infarction (STEMI) as clinical presentation. A stepwise increase in 3-year crude cumulative mortality was observed in the transition from SAP to STEMI (4.9% vs 6.1% vs 9.4%; p <0.01). Conversely, no differences in crude mortality rates were observed between 1 and 3 years across clinical presentations. After multivariable adjustment, STEMI was independently associated with greater risk of 3-year mortality (hazard ratio [HR] 3.45; 95% confidence interval [CI] 1.99 to 5.98; p <0.01), whereas no differences were observed between UAP or NSTEMI and SAP (HR 0.99; 95% CI 0.73 to 1.34; p = 0.94). In women with ACS, use of new-generation DES was associated with reduced risk of major adverse cardiac events (HR 0.58; 95% CI 0.34 to 0.98). The magnitude and direction of the effect with new-generation DES was uniform between women with or without ACS (pinteraction = 0.66). In conclusion, in women across the clinical spectrum of CAD, STEMI was associated with a greater risk of long-term mortality. Conversely, the adjusted risk of mortality between UAP or NSTEMI and SAP was similar. New-generation DESs provide improved long-term clinical outcomes irrespective of the clinical presentation in women.

Safety and efficacy of drug-eluting stents in women: a patient-level pooled analysis of randomised trials.

BACKGROUND: The safety and efficacy of drug-eluting stents (DES) in the treatment of coronary artery disease have been assessed in several randomised trials. However, none of these trials were powered to assess the safety and efficacy of DES in women because only a small proportion of recruited participants were women. We therefore investigated the safety and efficacy of DES in female patients during long-term follow-up. METHODS: We pooled patient-level data for female participants from 26 randomised trials of DES and analysed outcomes according to stent type (bare-metal stents, early-generation DES, and newer-generation DES). The primary safety endpoint was a composite of death or myocardial infarction. The secondary safety endpoint was definite or probable stent thrombosis. The primary efficacy endpoint was target-lesion revascularisation. Analysis was by intention to treat. FINDINGS: Of 43,904 patients recruited in 26 trials of DES, 11,557 (26·3%) were women (mean age 67·1 years [SD 10·6]). 1108 (9·6%) women received bare-metal stents, 4171 (36·1%) early-generation DES, and 6278 (54·3%) newer-generation DES. At 3 years, estimated cumulative incidence of the composite of death or myocardial infarction occurred in 132 (12·8%) women in the bare-metal stent group, 421 (10·9%) in the early-generation DES group, and 496 (9·2%) in the newer-generation DES group (p=0·001). Definite or probable stent thrombosis occurred in 13 (1·3%), 79 (2·1%), and 66 (1·1%) women in the bare-metal stent, early-generation DES, and newer-generation DES groups, respectively (p=0·01). The use of DES was associated with a significant reduction in the 3 year rates of target-lesion revascularisation (197 [18·6%] women in the bare-metal stent group, 294 [7·8%] in the early-generation DES group, and 330 [6·3%] in the newer-generation DES group, p<0·0001). Results did not change after adjustment for baseline characteristics in the multivariable analysis. INTERPRETATION: The use of DES in women is more effective and safe than is use of bare-metal stents during long-term follow-up. Newer-generation DES are associated with an improved safety profile compared with early-generation DES, and should therefore be thought of as the standard of care for percutaneous coronary revascularisation in women. FUNDING: Women in Innovation Initiative of the Society of Cardiovascular Angiography and Interventions.