Long term clinical outcome of sirolimus drug coated balloons in large coronary vessels.

BACKGROUND: Studies evaluating the safety and efficacy of drug coating balloons (DCB) for the treatment of lesions in large coronary vessel are limited. AIMS: Our study aimed to evaluate the performance of a sirolimus DCB in large coronary arteries. METHODS: We analyzed all the procedures included in the EASTBOURNE Registry (NCT03085823) enrolling patients with a clinical indication to percutaneous coronary intervention performed by a sirolimus DCB according to investigator judgment. In the present analysis, a cut-off of 2.75 mm was used to define large coronary arteries. Primary endpoint of the study was clinically driven target lesion revascularization (TLR) at 24 months whereas secondary endpoint included procedural success, myocardial infarction (MI), cardiac death and total mortality. RESULTS: Among the 2123 patients and 2440 lesions enrolled in the EASTBOURNE study between 2016 and 2020, 757 patients/810 lesions fulfilled the criteria for the present analysis. Mean reference vessel diameter was 3.2 ± 0.3 mm with mean lesion length of 22 ± 7 mm. Procedural success was high (96%) and at 2-year follow up the device showed a good efficacy with a TLR rate of 9%. There were 34 deaths (4.5%), 30 MIs (4%) and 8 BARC type 3-5 bleedings (1.1%). In-stent restenosis (629 lesions) and de novo lesions (181) were associated with 11% and 4% rates of TLR at 2 years, respectively (p = 0.003). CONCLUSIONS: Clinical performance of a sirolimus DCB in large coronary artery vessels shows promising signals at 2-year follow up, both in de novo and in-stent restenosis lesions.

Risk of SARS-CoV-2 infection in migrants and ethnic minorities compared with the general population in the European WHO region during the first year of the pandemic: a systematic review.

BACKGROUND: Migrants and ethnic minorities have suffered a disproportionate impact of the COVID-19 pandemic compared to the general population from different perspectives. Our aim was to assess specifically their risk of infection in the 53 countries belonging to the World Health Organization European Region, during the first year of the pandemic. METHODS: We conducted a systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PROSPERO CRD42021247326). We searched multiple databases for peer-reviewed literature, published on Medline, Embase, Scisearch, Biosis and Esbiobase in 2020 and preprints from PubMed up to 29/03/2021. We included cross-sectional, case-control, cohort, intervention, case-series, prevalence or ecological studies, reporting the risk of SARS-CoV-2 infection among migrants, refugees, and ethnic minorities. RESULTS: Among the 1905 records screened, 25 met our inclusion criteria and were included in the final analysis. We found that migrants and ethnic minorities during the first wave of the pandemic were at increased exposure and risk of infection and were disproportionately represented among COVID-19 cases. However, the impact of COVID-19 on minorities does not seem homogeneous, since some ethnic groups seem to be more at risk than others. Risk factors include high-risk occupations, overcrowded accommodations, geographic distribution, social deprivation, barriers to access to information concerning preventive measures (due to the language barrier or to their marginality), together with biological and genetic susceptibilities. CONCLUSIONS: Although mixed methods studies will be required to fully understand the complex interplay between the various biological, social, and cultural factors underlying these findings, the impact of structural determinants of health is evident. Our findings corroborate the need to collect migration and ethnicity-disaggregated data and contribute to advocacy for inclusive policies and programmatic actions tailored to reach migrants and ethnic minorities.

Sirolimus-Eluting Magnesium Resorbable Scaffold Implantation in Patients with Acute Myocardial Infarction.

To date, very little is known about the performance of a sirolimus-eluting bioresorbable magnesium scaffold (Mg-BRS) in patients with acute myocardial infarction (AMI). A multicenter cohort analysis was performed on 69 consecutive AMI subjects treated with Mg-BRS. Procedural success was obtained in all cases, and no in-hospital events were reported. At 9-month follow-up, no cardiac death, target-vessel myocardial infarction, ischemia-driven target lesion revascularization, or Mg-BRS thrombosis was reported. Although our analysis showed encouraging results, larger studies and longer-term follow-up are needed to better understand the potential benefits associated with the use of a Mg-BRS in AMI patients.

Clinical outcomes of patients with diabetes mellitus treated with Absorb bioresorbable vascular scaffolds: a subanalysis of the European Multicentre GHOST-EU Registry.

BACKGROUND: Data on the clinical performance of bioresorbable scaffolds in patients with diabetes mellitus (DM) are still limited. The present study reported 1-year clinical outcomes associated with the use of everolimus-eluting bioresorbable vascular scaffolds (Absorb BVS; Abbott Vascular, Santa Clara, CA) in DM patients. METHODS AND RESULTS: This was a subanalysis from the GHOST-EU (Gauging coronary Healing with biOresorbable Scaffolding plaTforms in Europe) multicenter retrospective registry including patients treated with Absorb BVS between November 2011 and September 2014. In this study, a comparative analysis stratified according to DM was performed. The primary endpoint was target lesion failure (TLF), defined as the combination of cardiac death, target-vessel myocardial infarction (MI) and clinically-driven target-lesion revascularization (TLR). A total of 1,477 patients were treated with 2,224 Absorb BVS; 381 (25.8%) and 1,096 (74.2%) patients were with and without DM, respectively. The 1-year rate of TLF was higher among patients with DM (7.8%) than those without DM (4.3%); the increase in TLF was driven by TLR (6.5% vs. 3.3%, P = 0.009); no significant differences in cardiac death (1.1% vs. 0.9%, P = 0.68) and target-vessel MI (3.1% vs. 2.2%, P = 0.38) were observed, respectively. Definite/probable scaffold thrombosis rate tended to be higher among patients with DM than those without DM (3.0% vs. 1.7%, P = 0.14, respectively). CONCLUSIONS: Absorb BVS use in patients with DM was associated with increased 1-year TLF and scaffold thrombosis compared with non-diabetes patients.

Coronary Artery Fistulae: Anatomy, Diagnosis and Management Strategies.

Coronary artery fistula (CAF) is a relatively rare anatomic abnormality of the coronary arteries that afflicts 0.002% of the general population and represents 14% of all the anomalies of coronary arteries. Its clinical relevance focusses mainly on the mechanism of "coronary steal phenomenon", causing myocardial functional ischaemia even in the absence of stenosis, hence common symptoms are angina or effort dyspnoea. The suggested diagnostic approach is guided by the patient's symptoms and consists of a number of instrumental examinations like ECG, treadmill test, echocardiography, computed tomography scan, cardiac magnetic resonance and coronary angiography. If it is not an incidental finding, coronary angiography is required in view of the optimal therapeutic planning. Small-sized fistulae are usually asymptomatic and have an excellent prognosis if managed medically with clinical follow-up with echocardiography every 2 to 5 years. In the case of symptomatic, large-sized or giant fistulae an invasive treatment, by transcatheter approach or surgical ligation, is usually a reasonable choice, and both strategies show equivalent results at long-term follow-up. Antibiotic prophylaxis for the prevention of bacterial endocarditis is recommended in all patients with coronary artery fistulae who undergo dental, gastrointestinal or urological procedures. A life-long follow-up is always essential to ensure that the patient is not undergoing progression of disease or further cardiac complications.

Bioresorbable vascular scaffold use for coronary bifurcation lesions: A substudy from GHOST EU registry.

OBJECTIVES: The aim of this study was to evaluate midterm outcomes of bioresorbable vascular scaffolds (BVS) implanted in bifurcation lesions. BACKGROUND: BVS have emerged as an alternative to conventional metallic drug-eluting stents for the treatment of coronary complex lesions. METHODS: Between November 2011 and January 2014, 1189 patients underwent percutaneous coronary intervention with BVS at 10 European centers (GHOST EU registry). Of these, 289 consecutive patients (302 bifurcation lesions) treated with either single-stenting (n = 260) or double-stenting (n = 42) were evaluated. RESULTS: True bifurcations were treated in 44.7%. Intravascular ultrasound and optical coherence tomography were utilized only in 22.2% and 21.2%, respectively. Predilation was performed in 95.4%, while postdilation of the main branch was performed in 61.3%. Final kissing inflation with no or minimal protrusion of a side-branch balloon into main branch was performed in 18.9%. Median follow-up period was 356 (IQR 191-419) days. The Kaplan-Meier estimated rates of target lesion failure and scaffold thrombosis (ST) were 6.4% and 2.5% at 360 days, respectively. Independent predictors for TLF were ACS and diabetes mellitus (HR 4.67; 95% CI: 1.78-12.3; P = 0.002 and HR 3.37; 95% CI: 1.38-8.26; P = 0.008, respectively). CONCLUSIONS: BVS use for coronary bifurcation lesions in an "all-comer" population was associated with acceptable TLF rates up to midterm follow-up. However, ST rates were higher than seen with contemporary metallic stents possibly due to the low incidence of intravascular guidance and postdilation resulting in a higher likelihood of scaffold underexpansion and malapposition, further supporting the importance of meticulous implantation technique. © 2016 Wiley Periodicals, Inc.

Impact of overlapping on 1-year clinical outcomes in patients undergoing everolimus-eluting bioresorbable scaffolds implantation in routine clinical practice: Insights from the European multicenter GHOST-EU registry.

BACKGROUND: Overlapping implantation of bioresorbable scaffolds (BRSs) are frequent in long coronary lesions. Its impact on clinical outcomes is unknown. OBJECTIVE: To compare the clinical outcomes of patients treated with overlapping BRS with those patients treated with no-overlap BRS. METHODS: We analyzed the 1-year clinical outcomes of 1,477 patients treated with BRS in the GHOST-EU registry, according to the implantation of overlapping BRS. Primary endpoint was patient oriented composite endpoint (PoCE) of: all-cause death, any myocardial infarction (MI) and any repeated revascularization. Scaffold thrombosis, according to Academic Research Consortium definition, was also analyzed. RESULTS: A total of 320 (21.7%) patients were treated with overlapping BRS (overlap group), whereas the remaining 1,157 (78.3%) received no-overlap BRS (no-overlap group). The overlap group had significantly higher frequency of male sex, diabetes mellitus, stable angina, B2/C lesion type, SYNTAX score ≥22, lesion length >34 mm, use of intracoronary imaging guidance, pre- and postdilatation. At 1-year, there were no differences in PoCE between the overlap versus no-overlap group (18.4% vs. 18.2%; HR 1.07, [0.80-1.44]; P = 0.636), even after adjustment (HR 1.05, [0.48-2.20]; P = 0.904). Scaffold thrombosis rate did not differ either at one-month (1.3% vs. 1.5%, P = 0.769) or at 1-year (1.9% vs. 2.1%, P = 0.823). CONCLUSIONS: In "Real-world" clinical practice, overlapping BRS does not appear to have an impact on clinical outcomes as compared to no-overlapping BRS. These preliminary data should be confirmed. © 2016 Wiley Periodicals, Inc.

Effect of inorganic nitrate on exercise capacity in heart failure with preserved ejection fraction.

BACKGROUND: Inorganic nitrate (NO3(-)), abundant in certain vegetables, is converted to nitrite by bacteria in the oral cavity. Nitrite can be converted to nitric oxide in the setting of hypoxia. We tested the hypothesis that NO3(-) supplementation improves exercise capacity in heart failure with preserved ejection fraction via specific adaptations to exercise. METHODS AND RESULTS: Seventeen subjects participated in this randomized, double-blind, crossover study comparing a single dose of NO3-rich beetroot juice (NO3(-), 12.9 mmol) with an identical nitrate-depleted placebo. Subjects performed supine-cycle maximal-effort cardiopulmonary exercise tests, with measurements of cardiac output and skeletal muscle oxygenation. We also assessed skeletal muscle oxidative function. Study end points included exercise efficiency (total work/total oxygen consumed), peak VO2, total work performed, vasodilatory reserve, forearm mitochondrial oxidative function, and augmentation index (a marker of arterial wave reflections, measured via radial arterial tonometry). Supplementation increased plasma nitric oxide metabolites (median, 326 versus 10 µmol/L; P=0.0003), peak VO2 (12.6±3.7 versus 11.6±3.1 mL O2·min(-1)·kg(-1); P=0.005), and total work performed (55.6±35.3 versus 49.2±28.9 kJ; P=0.04). However, efficiency was unchanged. NO3(-) led to greater reductions in systemic vascular resistance (-42.4±16.6% versus -31.8±20.3%; P=0.03) and increases in cardiac output (121.2±59.9% versus 88.7±53.3%; P=0.006) with exercise. NO3(-) reduced aortic augmentation index (132.2±16.7% versus 141.4±21.9%; P=0.03) and tended to improve mitochondrial oxidative function. CONCLUSIONS: NO3(-) increased exercise capacity in heart failure with preserved ejection fraction by targeting peripheral abnormalities. Efficiency did not change as a result of parallel increases in total work and VO2. NO3(-) increased exercise vasodilatory and cardiac output reserves. NO3(-) also reduced arterial wave reflections, which are linked to left ventricular diastolic dysfunction and remodeling. CLINICAL TRIAL REGISTRATION URL: www.clinicaltrials.gov. Unique identifier: NCT01919177.

Health inequalities: an analysis of hospitalizations with respect to migrant status, gender and geographical area.

BACKGROUND: The quality of care includes several aspects which may be influenced by social-economic status. This study analyzes hospitalizations for several conditions, such as chronic diseases, cancer and appendectomy, in Italians and immigrant people living in Italy with the aim to evaluate possible inequalities in the quality of health care services due to migrant status, gender and geographical macro-areas (Northern, Central, Southern Italy). METHODS: The data source of hospital discharges for stroke, myocardial infarction, chronic liver disease, cervical cancer, mastectomy and appendectomy was the Ministry of Health. ICD 9 codes were used for data collection. Crude and standardized hospitalization rates per 100.000 were calculated. Italian resident population and an estimate of immigrants living in Italy were used as denominators while standardization was done with respect to the European population. The data we used covers the 2006-2008 period. RESULTS: Immigrants showed significantly higher hospitalization rates for stroke, cervical cancer and appendectomy and significantly lower hospitalization rates for chronic liver diseases and mastectomy. Males showed significantly higher hospitalization rates than females for myocardial infarction, chronic liver diseases and appendectomy. Notwithstanding, differences related to migrant status and gender varied according to geographical macro-area. With respect to that, Southern Italy showed significantly higher hospitalization rates for stroke, myocardial infarction and chronic liver diseases and significantly lower hospitalization rates for mastectomy and appendectomy. CONCLUSIONS: The results of this study may reflect inequalities in the quality of health care, in particular in primary and secondary prevention, access to specialized care and inappropriateness, due to migrant status and gender. Also, differences between macro-areas suggest heterogeneities in the integration policies and the promotion of immigrants' health. Research should be endorsed in this field in order to further describe inequalities and their reasons and in the light of supporting policies development.

Acute coronary syndrome due to early multiple and complete fractures in sirolimus-eluting stent: a case report and brief literature review.

Despite drug eluting stents (DES), as compared to bare metal stents, have reduced in-stent restenosis, complex and long lesions remains a challenge for interventional cardiologist. Their treatment is often associated with an unfavorable outcome, related to in-stent restenosis, stent thrombosis, and target lesion revascularization. These complications may derive from the contact between metallic structures and coronary artery endothelium, and consequent overexpression of platelet activating factors, growth factors, and inflammatory cytokines. Recently, an additional mechanism has emerged as new cause of these complications: "stent fracture." Several factors are involved in this phenomenon including material and stent platform, target vessel features, stent implantation technique, and implant duration. We reported a case of 69 years old man with rare early and complex DES fractures on right coronary that caused acute coronary syndrome 36 hr after a previous percutaneous coronary intervention.

Tuberculosis case finding based on symptom screening among immigrants, refugees and asylum seekers in Rome.

BACKGROUND: In Italy the proportion of cases of tuberculosis in persons originating from high-prevalence countries has been increasing in the last decade. We designed a study to assess adherence to and yield of a tuberculosis screening programme based on symptom screening conducted at primary care centres for regular and irregular immigrants and refugees/asylum seekers. METHODS: Presence of symptoms suggestive of active tuberculosis was investigated by verbal screening in migrants presenting for any medical condition to 3 free primary care centres in the province of Rome. Individuals reporting at least one symptom were referred to a tuberculosis clinic for diagnostic workup. RESULTS: Among 2142 migrants enrolled, 254 (11.9%) reported at least one symptom suggestive of active tuberculosis and 176 were referred to the tuberculosis clinic. Of them, 80 (45.4%) did not present for diagnostic evaluation. Tuberculosis was diagnosed in 7 individuals representing 0.33% of those screened and 7.3% of those evaluated for tuberculosis. CONCLUSION: The overall yield of this intervention was in the range reported for other tuberculosis screening programmes for migrants, although we recorded an unsatisfactory adherence to diagnostic workup. Possible advantages of this intervention include low cost and reduced burden of medical procedures for the screened population. Further evaluation of this approach appears to be warranted.

Periprocedural outcome in patients undergoing left atrial appendage occlusion with the Watchman FLX device: The ITALIAN-FLX registry.

Introduction: The Watchman FLX is a novel device for transcatheter left atrial appendage occlusion (LAAO) specifically designed to improve procedural performance in more complex anatomies with a better safety profile. Recently, small prospective non-randomized studies have shown good procedural success and safety compared with previous experiences. Results from large multicenter registries are needed to confirm the safety and efficacy of the Watchman FLX device in a real-world setting. Methods: Italian FLX registry is a retrospective, non-randomized, multicentric study across 25 investigational centers in Italy including consecutive patients undergoing LAAO with the Watchman FLX between March 2019 and September 2021 (N = 772). The primary efficacy outcome was the technical success of the LAAO procedure (peri-device flow ≤ 5 mm) as assessed by intra-procedural imaging. The peri-procedural safety outcome was defined as the occurrence of one of the following events within 7 days after the procedure or by hospital discharge: death, stroke, transient ischemic attack, major extracranial bleeding (BARC type 3 or 5), pericardial effusion with tamponade or device embolization. Results: A total of 772 patients were enrolled. The mean age was 76 ± 8 with a mean CHA2DS2-VASc score of 4.1 ± 1.4 and a mean HAS-BLED score of 3.7 ± 1.1. Technical success was achieved in 772 (100%) patients with the first device implanted in 760 (98.4%) patients. A peri-procedural safety outcome event occurred in 21 patients (2.7%) with major extracranial bleeding being the most common (1.7%). No device embolization occurred. At discharge 459 patients (59.4%) were treated with dual antiplatelet therapy (DAPT). Conclusions: The Italian FLX registry represents the largest multicenter retrospective real-world study reporting periprocedural outcome of LAAO with the Watchman FLX device, resulting in a procedural success rate of 100% and a low incidence of peri-procedural major adverse events (2.7%).

Intra-Cardiac versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion with a Watchman FLX Device.

This study aimed to compare the peri-procedural success and complication rate within a large registry of intra-cardiac echocardiography (ICE)- vs. transesophageal echocardiography (TEE)-guided left atrial appendage occlusion (LAAO) procedures with a Watchmann FLX device. Data from 772 LAAO procedures, performed at 26 Italian centers, were reviewed. Technical success was considered as the final implant of a Watchmann FLX device in LAA; the absence of pericardial tamponade, peri-procedural stroke and/or systemic embolism, major bleeding and device embolization during the procedure was defined as a procedural success. One-year stroke and major bleeding rates were evaluated as outcome. ICE-guided LAA occlusion was performed in 149 patients, while TEE was used in 623 patients. Baseline characteristics were similar between the ICE and TEE groups. The technical success was 100% in both groups. Procedural success was also extremely high (98.5%), and was comparable between ICE (98.7%) and TEE (98.5%). ICE was associated with a slightly longer procedural time (73 ± 31 vs. 61.9 ± 36 min, p = 0.042) and shorter hospital stay (5.3 ± 4 vs. 5.8 ± 6 days, p = 0.028) compared to the TEE group. At one year, stroke and major bleeding rates did not differ between the ICE and TEE groups. A Watchmann FLX device showed high technical and procedural success rate, and ICE guidance does not appear inferior to TEE.

Tuberculosis in sheltered homeless population of Rome: an integrated model of recruitment for risk management.

The authors show the results of an integrated model for risk management of tuberculosis in a sample of sheltered homeless in Rome. Tuberculin skin test (TST) was used for evaluating the prevalence of latent infection (LTBI). In TST positives, expectorate was collected and chest X-ray was achieved. Multiple logistic regression analysis was performed to investigate determinants of infection. Out of 288 recruited subjects, 259 returned for the TST reading; 45.56% were positive and referred to a specialized center; 70 accessed the health facility and completed the clinical pathway. The risk factors associated to LTBI were male gender (OR = 3.72), age over 60 years (OR = 3.59), immigrant status (OR = 3.73), and obesity (OR = 2.19). This approach, based on an integrated social network, guarantees high adherence to screening (89.93%), allowing patients testing positive for latent tuberculosis infection to be diagnosed and rapidly referred to a specialized center.

[Immigration, trauma, living difficulties and psychopathology: a preliminary study in a primary care setting]. / Immigrazione, traumi, difficoltà vitali e psicopatologia: uno studio preliminare in un setting di medicina generale.

AIM: Investigate the prevalence of Post-Traumatic Stress Disorder (PTSD), anxiety, depression and somatizations in a sample of immigrants visited in a transcultural primary care service. The relationship among psychopathological symptoms, pre-migratory events and post-migration living difficulties is also considered. METHODS: We studied 101 outpatients, attending the "Caritas" Primary Care Unit for immigrants in Rome. All participants fulfilled a socio-demographic questionnaire, a checklist of traumatic events (Harvard Trauma Questionnaire, HTQ), a checklist of post-migration living difficulties (Post-Migration Living Difficulties, PMLD) and the following questionnaires: the HTQ for the assessment of post-traumatic symptoms, the Hopkins Symptom Checklist (HSCL-25) for anxiety and depression, the Bredford Somatic Inventory (BSI) for somatization. RESULTS: 40 patients (39.60%) had an anxiety disorder, 47 (46.13%) a depressive disorder, 16 (15.84%) a PTSD and 39 (38,6%) a somatization syndrome. All these syndromes were significantly correlated. The number of traumatic events and of post-migration difficulties significantly increased the scores on the psychopathological scales. DISCUSSION: The prevalence of psychopathological syndromes in our primary care transcultural unit was high. This not only in refugees, but also in immigrants for other reasons. Moreover, the levels of psychopathological distress were significantly influenced by the number of pre-migratory traumas and of living difficulties in the host country.

A service-learning experience in a free medical centre for undocumented migrants and homeless people.

BACKGROUND: Service-learning experiences, informed by the realities of poverty and marginalization, are important for the education of future health professionals in order to commit them to tackling health inequalities and working with underserved populations. At the Caritas Medical Centre for undocumented migrants and homeless in Rome, students obtain an educational experience of service. The aim of this study is to try to measure the long-term impact of this experience on the professional and life choices of the student participants. METHODS: A questionnaire was designed and distributed by email to all 19-29 years old participants in the experience. Responses were collected and analysed in a quantitative descriptive way and in a qualitative way using the knowledge, skills and attitudes model. RESULTS: One hundred and seven students responded from the total 763 questionnaires distributed. Ninety-five percent of participants expressed a very high overall satisfaction, 93% declared that the experience influenced his/her future personal choices, and 84% found that the experience influenced their professional choices. Results were arranged into 6 categories of comments: knowledge about the realities of migration, poverty, and marginalization; relational skills; collaborative skills; attitudes towards migrants, poor people and others; Attitudes towards future professions; Attitudes towards life. A final category was listed with self-reflective questions related to the experience. CONCLUSION: This research shows the importance of service-learning experiences made during academic studies from young students of medicine and other faculties. Developing a relationship with marginalized and homeless people, within a voluntary service setting, can influence the future professional and personal choices of students. Universities should recognize the value of such experiences and establish partnerships with non-profit organizations to allow future health professionals to confront health inequities and commit themselves to their reduction.

Health assessment for migrants and asylum seekers upon arrival and while hosted in reception centres: Italian guidelines.

BACKGROUND: During 2016-17, national guidelines were developed in order to provide evidence-based recommendations on health assessments for migrants and asylum seekers upon their arrival in Italy. METHODS: Scientific literature published between 2005 and 2016 was searched in different databases. A free search was also performed on international organizations' websites in order to identify additional relevant documents. A multidisciplinary panel discussed the resulting evidence and formulated recommendations. RESULTS: Evidence-based recommendations were formulated: signs and symptoms of specific diseases should to be actively searched for active TB, malaria, STI, intestinal parasites, diabetes, anaemia. In case of other health conditions (latent TB, HIV, HBV, HCV, STI, strongyloides, schistosoma, diabetes), testing should be offered to asymptomatic subjects coming from endemic areas or exposed to risk factors. Mass screening is recommended for anaemia and hypertension; a pregnancy test should be considered, while inclusion in cervical cancer screening and vaccination programs is recommended. A modulated, progressive approach was developed, covering an initial evaluation during rescue operations, a full medical examination at first line reception stage and the referral to national health services during second line reception. CONCLUSIONS: It is important to produce and periodically update guidelines on these issues and local peculiarities should be taken into account in their design and implementation. Guidelines can not only support economic sustainability, but also counteract stigmatization dynamics.

ImpaCt of an Optimal Implantation Strategy on Absorb Long-Term Outcomes: The CIAO Registry.

AIM: To compare the long-term outcomes of patients implanted with Absorb bioresorbable scaffold (BRS) with optimal versus suboptimal technique. METHODS AND RESULTS: All patients who received an Absorb between March 2012 and January 2016 were selected from 19 Italian centers databases to assess the impact of an optimal implantation technique (CIAO criteria) on long-term device-oriented composite end-point (DOCE) - including cardiac death (CD), target-vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) - on its single components and on scaffold thrombosis (ScT). CIAO criteria consist of predilation (balloon/vessel ratio 1:1), correct sizing (BRS/proximal reference vessel diameter -RVD- ratio 0.8-1.2) and high-pressure postdilation with non-compliant (NC) balloon (≥20 atm for balloon/BRS ratio 1:1 or ≥16 atm for a 0.25-0.5 mm oversized balloon). Among the 1.434 patients analyzed, 464 (32.4%) fulfilled all CIAO criteria for every BRS implanted (CIAO 3 group), while 970 (67.6%) did not in at least one of the received BRS (CIAO 0-1-2 group). At 31.0 (interquartile range -IQR- 24.8-38.5) months follow-up, CIAO criteria did not impact on DOCE (8.2% vs. 8.0%, p = 0.92), ID-TLR (6.9% vs. 7.1%, p = 0.72) or ScT (1.9% vs. 1.8%, p = 0.80) in the overall population. At multivariate analysis overall BRS length (p = 0.001), severely calcified lesions (p = 0.03) and absence of CIAO criteria (CIAO 0, p = 0.005) were independent predictors of DOCE in long-term follow-up. CONCLUSION: Our data suggest that strict application of an optimal Absorb implantation technique doesn't improve long-term DOCE or ScT but may mitigate the worse outcome of patients with calcific lesions.