Mediterranean diet trajectories and 20-year incidence of cardiovascular disease: The ATTICA cohort study (2002-2022).

BACKGROUND AND AIMS: Only few studies have assessed longitudinal dietary trends in relation to cardiovascular disease (CVD) risk. We aimed to evaluate the association between adherence to the Mediterranean diet, both baseline and longitudinal, and 20-year CVD incidence. METHODS AND RESULTS: This was a prospective study among 1988 Greek adults (50% men, age: 45 ± 14years). Adherence to the Mediterranean diet was evaluated at baseline and 10 years through the MedDietScore, based on which longitudinal Mediterranean diet trajectories were identified. CVD incidence was recorded at 20 years. Each one-unit increase in baseline MedDietScore was associated with an 8% reduction in 20-year CVD incidence. Compared to subjects in the lowest tertile of baseline MedDietScore, those in the highest exhibited a 44% lower 20-year CVD risk (relative risk: 0.56, 95% confidence interval: 0.32, 0.97) adjusted for age, sex, baseline body mass index, smoking, physical activity, presence of hypercholesterolemia, hypertension and diabetes mellitus, and family history of CVD; further adjustment for high-sensitivity C-reactive protein, uric acid and estimated glomerular filtration rate attenuated this association. Results were similar in models adjusted for longitudinal changes in body weight, physical activity and smoking, and 10-year medical status. Mediterranean diet trajectory analysis revealed that 24.7%, 8.6%, 45.8% and 20.9% of participants longitudinally sustained a low adherence, moved closer, moved away or sustained a high adherence, respectively; among those, the corresponding CVD incidence was 63.3%, 65.5%, 28.1% and 9.4% (p-value<0.001). CONCLUSION: The Mediterranean diet offers long-term protection against CVD, part of which is mediated by inflammation, uricemia and renal function.

Food Compass Score predicts incident cardiovascular disease: The ATTICA cohort study (2002-2022).

BACKGROUND: The Food Compass Score (FCS) is a novel nutrient profiling system, which evaluates food and diet quality. The present study aimed to prospectively assess the relationship of FCS with short-term (10 years) and long-term (20 years) cardiovascular disease (CVD) incidence and to explore whether this relationship is modified by long-term adherence to a Mediterranean type diet (MTD). METHODS: Volunteers of the ATTICA cohort study, with complete data for the calculation of FCS and incident CVD were included (n = 759). Development of CVD was determined at 10 and 20 years after baseline. Dietary intake was assessed through a validated food frequency questionnaire. The FCS was calculated for each participant based on the published algorithm. Long-term adherence to a MTD was evaluated through MedDietScore. RESULTS: FCS was inversely associated with CVD incidence (hazard ratio [HR] for 20-year follow-up = 0.97, 95% confidence interval [CI] = 0.95-0.99; HR for 10-year follow-up = 0.98, 95% CI = 0.96-1.01) in the total sample, as well as in those with a high baseline adherence to a MTD (HR for 20-year follow-up = 0.96, 95% CI = 0.93-0.99; HR for 10-year follow-up = 0.98, 95% CI = 0.95-1.02). FCS was also inversely associated with CVD risk in those who went away from the MTD (HR = 0.97, 95% CI = 0.96-0.99). CONCLUSIONS: FCS, a novel tool for assessing overall diet quality, was also found to be useful in identifying potential CVD candidates in a long-term period, even in populations with good background dietary habits, such as those following a MTD.

Greater fruit and vegetables consumption, and adherence to a Mediterranean type of diet reduces the risk for asthma in children; a systematic review and meta-analysis.

The objective of this study was to explore the relationship between the consumption of fruits, vegetables and adherence to the Mediterranean diet with childhood asthma development and severity. A systematic literature search and synthesis of the results was performed throughout the last two decades. A total of 45 studies were analysed and 392,797 children were included. Greater adherence to a Mediterranean type of diet was inversely associated with asthmatic outcomes (OR:0.71,95% CI:0.54,0.88). Regarding fruits, vegetables consumption, a significant inverse association between increased fruits or vegetable intake and asthma was found (OR:0.82,95% CI:0.77,0.86; 0.84,95% CI:0.77,0.91, respectively). Fruits and vegetables consumption combined was also inversely related to all asthmatic outcomes (OR:0.65,95% CI:0.49,0.78). The level of heterogeneity was moderate-to-high (30%-97%). The present review and meta-analysis show a trend to an inverse association between adherence to the Mediterranean diet or a healthy diet rich in fruits and vegetables and the occurrence of childhood asthma but with a low level of certainty.

Report of the First ONTOX Stakeholder Network Meeting: Digging Under the Surface of ONTOX Together With the Stakeholders.

The first Stakeholder Network Meeting of the EU Horizon 2020-funded ONTOX project was held on 13-14 March 2023, in Brussels, Belgium. The discussion centred around identifying specific challenges, barriers and drivers in relation to the implementation of non-animal new approach methodologies (NAMs) and probabilistic risk assessment (PRA), in order to help address the issues and rank them according to their associated level of difficulty. ONTOX aims to advance the assessment of chemical risk to humans, without the use of animal testing, by developing non-animal NAMs and PRA in line with 21st century toxicity testing principles. Stakeholder groups (regulatory authorities, companies, academia, non-governmental organisations) were identified and invited to participate in a meeting and a survey, by which their current position in relation to the implementation of NAMs and PRA was ascertained, as well as specific challenges and drivers highlighted. The survey analysis revealed areas of agreement and disagreement among stakeholders on topics such as capacity building, sustainability, regulatory acceptance, validation of adverse outcome pathways, acceptance of artificial intelligence (AI) in risk assessment, and guaranteeing consumer safety. The stakeholder network meeting resulted in the identification of barriers, drivers and specific challenges that need to be addressed. Breakout groups discussed topics such as hazard versus risk assessment, future reliance on AI and machine learning, regulatory requirements for industry and sustainability of the ONTOX Hub platform. The outputs from these discussions provided insights for overcoming barriers and leveraging drivers for implementing NAMs and PRA. It was concluded that there is a continued need for stakeholder engagement, including the organisation of a 'hackathon' to tackle challenges, to ensure the successful implementation of NAMs and PRA in chemical risk assessment.

Breast Implants and the Risk of Squamous Cell Carcinoma of the Breast: A Systematic Literature Review and Epidemiologic Study.

Squamous cell carcinoma may arise primarily from the breast parenchyma (PSCCB) or from the periprosthetic capsule in patients with breast implants (breast implant-associated squamous cell carcinoma [BIA-SCC]). A systematic literature review was performed to identify all PSCCB and BIA-SCC cases, and to estimate prevalence, incidence rate (IR), and risk. Studies up to November 2023 were searched on PubMed, Web of Science, Google Scholar, and Cochrane Library for predefined keywords. The numerator for PSCCB and BIA-SCC was the number of cases obtained from the literature; the denominator for PSCCB was the female population aged from 18 to 99, and the denominator for BIA-SCC was the population with breast implants. Overall, 219 papers were included, featuring 2250 PSCCB and 30 BIA-SCC cases. PSCCB prevalence was 2.0 per 100,000 (95% CI, 0.2:100,000 to 7.2:100,000) individuals, with a lifetime risk of 1:49,509 (95% CI, 0.2:10,000 to 5.6:10,000); and BIA-SCC prevalence was 0.61 per 100,000 (95% CI, 0.2:100,000 to 1.3:100,000), with a lifetime risk of 1:164,884 (95% CI, 0.2:100,000 to 5.6:100,000). The prevalence of BIA-SCC is 3.33 times lower than that of PSCCB, while the prevalence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is 3.84 times higher than that of primary breast ALCL. When comparing the BIA-SCC prevalence of 1:164,910 individuals with breast implants regardless of texture to the BIA-ALCL prevalence of 1:914 patients with textured implants, the BIA-SCC risk is 180 times lower than the BIA-ALCL risk. BIA-SCC occurs less frequently than PSCCB and considerably less than BIA-ALCL. The association between textured implants and BIA-SCC cases is relevant for patient education regarding uncommon and rare risks associated with breast implants, and ongoing vigilance, research, and strengthened reporting systems remain imperative.

The role of skeletal muscle mass on cardiovascular disease risk: an emerging role on modulating lipid profile.

PURPOSE OF REVIEW: The purpose of this review was to present updated evidence on the role of skeletal muscle mass on cardiometabolic health. RECENT FINDINGS: Increased lean, and especially skeletal, muscle mass has been associated with better cardiometabolic health in various epidemiological studies, even in younger age groups. In addition, the link between skeletal muscle mass and adult lipid profile is of interest. A preliminary analysis using the data from the ATTICA prospective cohort study (2002-2022) supports this association. SUMMARY: Skeletal muscle mass has many metabolic functions (i.e., glucose, insulin and protein metabolism, mitochondrial function, arterial stiffness, inflammation, oxidative stress, brain function, hormone status). Given its associations with the lipid profile and overall cardiometabolic risk, skeletal muscle mass stands among the emerging risk factors for cardiovascular diseases. In addition to only using body mass index or fat distribution, more studies should evaluate lean mass and its prognostic and predictive ability regarding chronic diseases.

Are serum uric acid levels predictors of cardiovascular risk? An update.

PURPOSE OF REVIEW: The aim of this review was to update the evidence regarding the link between serum uric acid and cardiovascular risk, as well as the role of nutrition in the prevention and management of hyperuricaemia. RECENT FINDINGS: The review focuses on recent epidemiological evidence concerning the role of elevated serum uric acid levels in cardiovascular risk prediction. The dietary prevention and management of hyperuricaemia is also discussed with an emphasis on the adoption of prudent dietary patterns. SUMMARY: There is evidence supporting that elevated serum uric acid levels are positively associated with cardiovascular disease risk and might represent a useful additional marker for risk stratification. The association of serum uric acid with all-cause and cardiovascular mortality seems to be U-shaped, suggesting that both very low and very high serum uric acid levels might be detrimental for survival, the former being mediated by malnutrition. Apart from medication, the dietary management of hyperuricaemia should focus on the adoption of a prudent dietary pattern, such as the Mediterranean diet, which can both prevent gout and mitigate cardiometabolic risk.

Association of fructose consumption with prevalence of functional gastrointestinal disorders manifestations: results from Hellenic National Nutrition and Health Survey (HNNHS).

The study aimed to assess the total prevalence of functional gastrointestinal disorders (FGID), and separately, irritable bowel syndrome (IBS) among adults and to determine their potential association with fructose consumption. Data from the Hellenic National Nutrition and Health Survey were included (3798 adults; 58·9 % females). Information regarding FGID symptomatology was assessed using self-reported physician diagnosis questionnaires the reliability of which were screened using the ROME III, in a sample of the population. Fructose intake was estimated from 24 h recalls, and the MedDiet score was used to assess adherence to the Mediterranean diet. The prevalence of FGID symptomatology was 20·2 %, while 8·2 % had IBS (representing 40·2 % of total FGID). The likelihood of FGID was 28 % higher (95 %CI: 1·03-1·6) and of IBS 49 % (95 %CI: 1·08-2·05) in individuals with higher fructose intake than with lower intake (3rd tertile compared with 1st). When area of residence was accounted for, individuals residing in the Greek islands had a significantly lower probability of FGID and IBS compared with those residing in Mainland and the main Metropolitan areas, with Islanders also achieving a higher MedDiet score and lower added sugar intake, comparatively to inhabitants of the main metropolitan areas. FGID and IBS symptomatology was most prominent among individuals with higher fructose consumption, and this was most conspicuous in areas with a lower Mediterranean diet adherence, suggesting that the dietary source of fructose rather than total fructose should be examined in relation to FGID.

Methodological issues of the electronic health records' use in the context of epidemiological investigations, in light of missing data: a review of the recent literature.

BACKGROUND: Electronic health records (EHRs) are widely accepted to enhance the health care quality, patient monitoring, and early prevention of various diseases, even when there is incomplete or missing information in them. AIM: The present review sought to investigate the impact of EHR implementation on healthcare quality and medical decision in the context of epidemiological investigations, considering missing or incomplete data. METHODS: Google scholar, Medline (via PubMed) and Scopus databases were searched for studies investigating the impact of EHR implementation on healthcare quality and medical decision, as well as for studies investigating the way of dealing with missing data, and their impact on medical decision and the development process of prediction models. Electronic searches were carried out up to 2022. RESULTS: EHRs were shown that they constitute an increasingly important tool for both physicians, decision makers and patients, which can improve national healthcare systems both for the convenience of patients and doctors, while they improve the quality of health care as well as they can also be used in order to save money. As far as the missing data handling techniques is concerned, several investigators have already tried to propose the best possible methodology, yet there is no wide consensus and acceptance in the scientific community, while there are also crucial gaps which should be addressed. CONCLUSIONS: Through the present thorough investigation, the importance of the EHRs' implementation in clinical practice was established, while at the same time the gap of knowledge regarding the missing data handling techniques was also pointed out.

Government interventions and control policies to contain the first COVID-19 outbreak: An analysis of evidence.

BACKGROUND: The overarching aim of this study was to evaluate the effectiveness over time of government interventions and policy restrictions and the impact of determinants on spread and mortality during the first-wave of the COVID-19 pandemic, globally, regionally and by country-income level, up to 18 May 2020. METHODS: We created a global database merging World Health Organization daily case reports (from 218 countries/territories) with other socio-demographic and population health measures from 21 January to 18 May 2020. A four-level government policy interventions score (low to very high) was created based on the Oxford Stringency Index. RESULTS: Our results support the use of very high government interventions to suppress both COVID-19 spread and mortality effectively during wave one globally compared to other policy levels of control. Similar trends in virus propagation and mortality were observed in all country-income levels and specific regions. CONCLUSIONS: Rapid implementation of government interventions was needed to contain the first wave of the COVID-19 outbreak and to reduce COVID-19-related mortality.

Exploring the Role of Irrational Beliefs, Lifestyle Behaviors, and Educational Status in 10-Year Cardiovascular Disease Risk: the ATTICA Epidemiological Study.

BACKGROUND: Irrational beliefs, maladaptive emotions, and unhealthy lifestyle behaviors can adversely affect health status. However, limited research has examined the association between irrational beliefs and cardiovascular disease (CVD). The aim of this study was to evaluate the association between irrational beliefs and the 10-year CVD incidence among apparently healthy adults, considering the potential moderating or mediating role of particular social and lifestyle factors. METHODS: The ATTICA study is a population-based, prospective cohort (2002-2012), in which 853 participants without a history of CVD [453 men (aged 45 ± 13 years) and 400 women (aged 44 ± 18 years)] underwent psychological evaluations. Among other tools, participants completed the irrational beliefs inventory (IBI, range 0-88), a self-reported measure consistent with the Ellis model of psychological disturbance. Demographic characteristics, detailed medical history, dietary, and other lifestyle habits were also evaluated. Incidence of CVD (i.e., coronary heart disease, acute coronary syndromes, stroke, or other CVD) was defined according to the International Coding Diseases (ICD)-10 criteria. RESULTS: Mean IBI score was 53 ± 2 in men and 53 ± 3 in women (p = 0.88). IBI score was positively associated with 10-year CVD risk (hazard ratio 1.07, 95%CI 1.04, 1.13), in both men and women, and more prominently among those with less healthy dietary habits and lower education status; specifically, higher educational status leads to lower IBI score, and in conjunction they lead to lower 10-year CVD risk (HR for interaction 0.98, 95%CI 0.97, 0.99). CONCLUSIONS: The findings of this study underline the need to build new, holistic approaches in order to better understand the inter-relationships between irrational beliefs, lifestyle behaviors, social determinants, and CVD risk in individuals.

Association Between Family History of Diabetes, Irrational Beliefs, and Health Anxiety with 10-Year Risk of Type 2 Diabetes Mellitus: the ATTICA Epidemiological Study (2002-2012).

BACKGROUND: This study aimed to examine the relationship between family history of diabetes, irrational beliefs, and health anxiety in the development of type 2 diabetes mellitus (T2DM). METHOD: ATTICA is a prospective, cohort study (2002-2012). The working sample included 845 participants (18-89 years), free of diabetes at baseline. Α detailed biochemical, clinical, and lifestyle evaluation was performed, while participants' irrational beliefs and health anxiety were assessed through the Irrational Beliefs Inventory and the Whiteley index scale, respectively. We evaluated the association between the participants' family history of diabetes mellitus with the 10-year risk of diabetes mellitus, both in the total study's sample and separately according to their levels of health anxiety and irrational beliefs. RESULTS: The crude 10-year risk of T2DM was 12.9% (95%CI: 10.4, 15.4), with 191 cases of T2DM. Family history of diabetes was associated with 2.5 times higher odds (2.53, 95%CI 1.71, 3.75) of T2DM compared to those without family history. Among participants with family history of diabetes, the highest likelihood of developing T2DM, regarding their tested psychological features (i.e., low/high irrational beliefs in the entire group, low/high health anxiety in the entire group, and low/high irrational beliefs, low/high healthy anxiety), had people with high irrational beliefs, low health anxiety (OR 3.70, 95%CI 1.83, 7.48). CONCLUSIONS: The findings underline the important moderating role of irrational beliefs and health anxiety in the prevention of T2DM, among participants at increased risk of T2DM.

Psychological interventions aiming for changing dietary habits in patients with cardiovascular disease: A systematic review and meta-analysis.

BACKGROUND: Diet is a critical component of healthy lifestyle, especially in cardiac rehabilitation. Psychological interventions, as well as mix-treatment interventions, such as psychological components, appear promising approaches in the adoption and maintenance of a healthy diet in patients with cardiovascular disease (CVD). Given the variety of clinical intervention programmes available, we aimed to determine whether psychological interventions and interventions that incorporate psychological components provide better lifestyle outcomes than traditional care, specifically targeting dietary outcomes, and what types of psychological or mix-treatment interventions are more likely to benefit patients with CVD. METHODS: A systematic literature search was performed using MEDLINE (PubMed), Scopus, Cochrane Library and PsycINFO to identify interventional studies, published from 2012 to 2022, written in English, evaluating psychological and mix-treatment intervention programmes for dietary outcomes in patients with CVD. In total, 33 intervention studies (n = 5644 patients) were retrieved and analysed using fixed and random effects models. RESULTS: No significant effect of the psychological intervention was observed regarding fruit and vegetable intake (Hedge's g = +1.06, p = 0.766), whereas a significant reduction was observed in alcoholic beverage consumption in the intervention group, as compared to the control group (Hedge's g = -7.33, p < 0.001). However, based on both our qualitative and quantitative analyses, psychological and mix-treatment interventions were more effective than traditional models in dietary modification. Also, the majority of effective interventions were psychological over mixed-treatment interventions. CONCLUSIONS: Findings add to the growing evidence suggesting that specific psychological interventions may be effective approaches in dietary modification for patients with CVD, potentially forming part of public health agenda.

The association of specific types of vegetables consumption with 10-year type II diabetes risk: Findings from the ATTICA cohort study.

BACKGROUND: The present study aimed to investigate the association between vegetable consumption, in total as well as per type/category, and 10-year type-2 diabetes mellitus (T2DM) incidence. METHODS: The ATTICA study was conducted during 2001-2012 in 3042 apparently healthy adults living in Athens area, Greece. A detailed biochemical, clinical, and lifestyle evaluation was performed; vegetable consumption (total, per type) was evaluated through a validated semi-quantitative food frequency questionnaire. After excluding those with no complete information of diabetes status or those lost at the 10-year follow-up, data from 1485 participants were used for the current analysis. RESULTS: After adjusting for several participants' characteristics, including overall dietary habits, it was observed that participants consuming at least 4 servings/day of vegetables had a 0.42-times lower risk of developing T2DM (hazard ratio [HR] = 0.42; 95% confidence interval [CI] = 0.29-0.61); the benefits of consumption were greater in women (HR = 0.29; 95% CI = 0.16-0.53) compared to men (HR = 0.56; 95% CI = 0.34-0.92). Only 33% of the sample consumed vegetables 4 servings/day. The most significant associations were observed for allium vegetables in women and for red/orange/yellow vegetables, as well as for legumes in men. CONCLUSIONS: The intake of at least 4 servings/day of vegetables was associated with a considerably reduced risk of T2DM, independently of other dietary habits; underlying the need for further elaboration of current dietary recommendations at the population level.

Adherence to a Mediterranean type of diet in the world: a geographical analysis based on a systematic review of 57 studies with 1,125,560 participants.

This systematic review aimed to assess the level and time-trends of adherence to Mediterranean-type diets (MTD) among the general population, globally. According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses, a comprehensive literature search of the MEDLINE and Scopus databases was carried out, until 04/09/2023, based on specific criteria. Fifty-seven studies with 1,125,560 apparently healthy adults from Europe (n = 37), US (n = 8), Asia (n = 8), Australia (n = 4) and Africa (n = 1) were included. Adherence to an MTD was moderate with a significant decline observed in the last decade. European countries, mainly driven by Mediterranean countries, showed higher adherence than other regions. Geographical analysis revealed that adherence to an MTD is related to both geographic location and socioeconomic status throughout the world.

The path between breakfast eating habit, sleep duration and physical activity on obesity status: An epidemiological study in schoolchildren.

Background: Although the literature suggests that skipping breakfast, insufficient sleep, and reduced physical activity are associated with childhood obesity their co-influence and their in-between interactions on weight status have rarely been studied. Aim: To examine the co-influence of breakfast eating habits, sleep duration, and physical activity on the weight status of children 10-12 years old from several schools of Greece. Methods: A cross-sectional study was conducted on 1688 students in Greece, during 2014-2016. Children's Body Mass Index (BMI) was calculated and classified according to the International Obesity Task Force (IOTF) classification. Logistic regression models and path analysis were used. Results: Overweight/obesity prevalence was higher in boys (32.5% vs. 20.4%; p < 0.001). Average sleep duration decreased the odds of overweight/obesity [OR (95% CI): 0.86 (0.76, 0.97)] independently of the frequency of breakfast habit. Interaction between sleep duration with breakfast habit (p = 0.002) and physical activity (p < 0.001) was observed. Path analysis showed a negative association of BMI with sleep duration (standardized beta = -0.095, p < 0.001). A third-order interaction between breakfast habit, sleep duration, and physical activity revealed that daily breakfast eating along with adequate sleep and moderate/adequate physical activity levels, decreased the odds of over-weight/obesity by 55% [OR 0.45, 95% CI (0.27, 0.72)]. Conclusion: Although sleep duration is inversely associated with weight status independently of breakfast habit, the co-influence of adequate sleep duration with frequent breakfast eating and moderate/adequate physical activity seems to be a profoundly higher associated as a result of synergy against childhood obesity.

Adherence to the Mediterranean Diet and Successful aging in Greeks living in Greece and abroad: the epidemiological Mediterranean Islands Study (MEDIS).

Background: Whether older immigrant populations from the Mediterranean region, continue to follow the MD long after they immigrated is not known. Aim: Compare adherence to the MD and successful aging levels between Greeks living in Greece (GG) and Greeks living abroad (GA). Methods: Anthropometrical, clinical, psychological, sociodemographic, dietary and lifestyle parameters were assessed in a cross-sectional manner in a sample of 252 GG and 252 GA. Mediterranean Diet Score (MedDietScore range 0-55) was used to assess adherence to the MD. Successful aging was evaluated with the validated successful aging index (SAI range 0-10). Results: GA presented higher adherence to MD (p < 0.001); they were consuming significantly more cereals, legumes, vegetables, and fruits compared to GG. GG consumed significantly more dairy (3.8 ± 2.9 vs. 1.9 ± 2.2, p < 0.001) and potatoes (2.4 ± 1.6 vs. 1.9 ± 1.5, p < 0.001) compared to GA. Meat (p = 0.27), poultry (p = 0.72), fish (p = 0.68), olive oil (p = 0.16) and alcohol consumption (p = 0.05) were comparable between the two groups (all p's > 0.05). MedDietScore was positively associated with SAI among both groups after adjusting for possible confounders (0.041 ± 0.014, p = 0.003 GG and 0.153 ± 0.035, p < 0.001 GA). Also, legumes, cereals, fruits and vegetables were found to be beneficial for successful aging. Conclusion: Adherence to the MD is associated with higher levels of successful aging among people of the same genetic background living in different environments. However, traditional dietary habits are gradually abandoned in their native countries, when, at the same time, are considered cultural heritage and preserved accordingly among immigrants.

BIA-ALCL Epidemiological Findings From a Retrospective Study of 248 Cases Extracted From Relevant Case Reports and Series: A Systematic Review.

BACKGROUND: The epidemiologic picture of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is unclear, with no high-level evidence, because only case reports and series are available. OBJECTIVES: The aim of this study was to update knowledge on BIA-ALCL epidemiology by utilizing all available data through a systematic review of scientific literature. METHODS: A search on PubMed, Scopus, and Web of Science was conducted between October 2021 and April 2022. Out of the 2799 available records, 114 pertinent articles were selected, featuring 248 BIA-ALCL cases which were retrospectively analyzed by means of descriptive statistics, incidence rate (IR), Kaplan-Meier survival curves, and Pearson correlation coefficients. RESULTS: The United States, the Netherlands, Italy, and Australia were the countries reporting the most cases. The mean age at first implantation was 42 years, and the mean age at diagnosis was 53 years. Aesthetic indications were the reason for 52% of cases, and reconstruction for 48%; macrotextured surface was linked to 73.8% of cases, and seroma to 83%. Total follow-up was 492 months, and mean event-free time (EFT) to BIA-ALCL development was 129 months. The IR was 96 new cases/1,000 women per year after first implantation, and was directly correlated to the number of replacements. EFT was directly correlated to the number of replacements, implant rupture, and capsule contracture, and was inversely associated with patients' age at first implantation and to BRACA1/2 and TP53 mutations. CONCLUSIONS: Macrotextured implant use in older patients and in patients with BRCA1/2 and TP53 mutations should be reconsidered, because this is associated with earlier disease onset. Implant replacement of asymptomatic, risk-stratified patients can be indicated due to its protective role against BIA-ALCL, reducing IR and risk, while increasing the EFT.

Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma in the United States: A Systematic Review.

BACKGROUND: Although textured implants represent fewer than 10% of implants used in the United States, the country reports the highest incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). OBJECTIVES: The aim of this study was to perform a systematic literature review on US-based epidemiology to update knowledge on BIA-ALCL in the United States. METHODS: Publications on US BIA-ALCL epidemiology were searched between September 2022 and March 2023 on MEDLINE (National Institutes of Health; Bethesda, MD), Embase (Elsevier, Amsterdam, the Netherlands), Web of Science (Clarivate, London, UK), and SCOPUS (Elsevier, Amsterdam, the Netherlands). The US numerator was obtained by averaging the FDA MAUDE database and the PSF PROFILE registry, while the denominator was estimated from chest X-rays, and included female transgender individuals. Prevalence and risk were assessed accordingly, but the incidence rate (IR) could not be updated due to the lack of available follow-up data. RESULTS: Out of 987 identified manuscripts, 10 were included. The US prevalence of BIA-ALCL in the literature ranged from 1:300 to 1:500,000 and the IR from 4.5 per 10,000 to 31.1 per 100 million persons per year. A mean value of 453.5 BIA-ALCL cases was calculated. From a denominator of 4,264,618 individuals, which includes all breast implant surfaces, we calculated 414,521 individuals with textured implants, indicating a textured prevalence of 109.4 cases per 100,000 individuals and a risk of 1:913. CONCLUSIONS: BIA-ALCL IR, prevalence, and risk has increased when calculated exclusively for patients with textured devices. Although US macrotextured implants were recalled by the FDA, these findings may influence the surveillance of existing patients and the use of macrotextured implants in other parts of the world where they remain widespread.

BIA-ALCL Epidemiology in an Aesthetic Breast Surgery Cohort of 1501 Patients.

BACKGROUND: Epidemiologic studies on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) currently estimate the risk between 1:300 and 1:30,000, assessed mainly in large breast reconstruction populations. OBJECTIVES: The aim of the study was to assess BIA-ALCL epidemiology in a cohort of patients who have received textured implants for cosmetic indications. METHODS: In a prospective cohort observational study, 1501 patients who received a cosmetic breast augmentation between 2006 and 2016 were monitored, recording any implant-related complications, including BIA-ALCL. Cross-checking of clinical, pathology, and external records data identified cases. Prevalence, implant-specific prevalence (I-SP), incidence rate (IR), event-free time (EFT), and the Kaplan-Meier survival estimate were calculated. RESULTS: All but 2 patients received macrotextured or microtextured devices bilaterally. Mean follow-up was 3.2 years (1 months to 16.4 years). Five BIA-ALCL cases were investigated. Prevalence was 1:300 patients; I-SP was 6.9 cases/1000 individuals/Allergan BIOCELL devices and 1.3 cases/1000 individuals/Mentor Siltex devices; and IR was 1.07 cases/1000 females/year. Mean (SD) EFT was 9.2 years. CONCLUSIONS: When using a denominator based on a cohort of cosmetic patients, BIA-ALCL occurrence is higher than previously reported, particularly with macrotextured devices. Given the similar IRs in reconstructive and cosmetic cohorts, their even distribution could be consequent to underreporting due to poorer follow-up and lower awareness in the latter group. The genetic predisposition in the oncologic cohort reasonably affects the early onset more than the IR. The importance of accurate follow-up is confirmed. Stratification risks analysis can guide surgeons during patient counseling regarding the decision for prophylactic explantation.