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.

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.

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%).

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.

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.

Epicardial fat study-AG: relationship between echocardiographic epicardial fat and coronary artery disease in patients after invasive coronary artery angiography.

Background: Epicardial fat increase has not yet a clear correlation with coronary artery disease (CAD). Aim: This study had as goal to demonstrate a relationship between an increase of epicardial fat thickness (EFT) and CAD. Materials & methods: In this observational study, we included 234 patients who underwent invasive coronary angiography. Before invasive coronary angiography, all patients underwent echocardiographic-2D for evaluation of EFT and they were divided into groups based on Gensini score and also on Syntax score. Results: EFT was significantly correlated to the presence and severity of CAD assessed by Gensini score with a cut-off value of 5.2 mm (sensitivity of 90.9%-specificity of 87.3%- area under the ROC curve = 92.1%). Conclusion: EFT increase (fat index ≥5.2 mm) evaluated by echocardiographic-2D could be considered as a risk factor for predicting CAD.

The impact of the use of bioresorbable vascular scaffolds and drug-coated balloons in coronary bifurcation lesions.

BACKGROUND: Despite the improvement in techniques and tools, coronary lesions involving a bifurcation are still challenging and the outcome with drug-eluting stents is not always optimal. The role of bioresorbable vascular scaffolds (BVS) and drug-coated balloons (DCB) in this setting has not been adequately investigated yet. RESULTS: From the databases of 6 italian centers with high proficiencies in newer technologies, we retrospectively collected all consecutive cases of coronary bifurcations managed or attempted with the implantation of at least one BVS in the main vessel and the use of one DCB in the side branch (SB). Primary study endpoint was the occurrence of major adverse cardiovascular events (MACE) at the longest available follow-up. Fourty patients fulfilled the enrollment criterion, 22.5% had diabetes and 50% an acute coronary syndrome. Average syntax score was 15.04 ± 7.18, all lesions were de novo, and 27 patients (67.5%) had a type 1,1,1 Medina lesion. Twenty-three lesions (57.5%) involved the proximal left anterior-descending artery/first diagonal branch. Only 32.5% of patients underwent an intravascular imaging-guided angioplasty. Average lesion length was 21.4 mm in the main vessel and 11.49 mm in the SB. MV was always predilated and BVS received a postdilation in 100% of the cases. In 42.5% of the cases, the DCB was used during final kissing balloon inflation, and in no cases, a stent/BVS was required in the SB. Procedural success was achieved in 100% of the cases. After an average follow-up of 15.5 (± 11.5) months, we observed no MACE with only one case of target vessel revasularization (2.5%). CONCLUSIONS: Management of coronary bifurcation lesions with the use of newer technologies including BVS and DCB seems feasible and effective at mid-term and long-term clinical follow-up.

Immigration Emergency in Italy: The Impact of Socioeconomic Status on Blood Pressure Levels and Control.

INTRODUCTION: Nowadays there are more than 5 millions of immigrants (8.3% of general adult population) in Italy. AIM: To evaluate the potential impact of immigration and the possession of a permanent residence on blood pressure (BP) levels and control in a low income population of immigrants from different countries. METHODS: We evaluated clinical characteristics and social status of adult individuals with known diagnosis of hypertension afferent to the Poliambulatorio della Caritas Diocesana in Rome, Italy, between 2010-2016. Subjects were stratified according to their macro-areas of origin (Europe, Asia, Africa, South-America), housing (with or without house), and immigration status (presence or absence of residence permit). BP levels were measured in three consecutive visits according to recommendations from current European Guidelines. RESULTS: From an overall population sample of 9827 adult individuals, we initially identified 994 patients with a diagnosis of hypertension (10.1%), among whom 536 (5.4%) had valid BP data. Among these, 50.6% came from Europe, 21.6% from Africa, 24.1% from Asia, and 3.7% from South-America. They were predominantly male (54.7%), middle aged (42.8 ± 12.1 years at arrival and 51.6 ± 10.6 years at first visit) and untreated (72.8%) individuals with baseline systolic/diastolic BP levels of 156.9 ± 22.2/97.3 ± 12.4 mmHg). BP levels remained higher in homeless than in housed people at both visit 2 (150.0 ± 21.8/92.6 ± 12.9 mmHg vs. 142.9 ± 19.3/89.9 ± 11.6 mmHg; P < 0.001) and visit 3 (147.9 ± 22.2/91.7 ± 12.5 mmHg vs. 141.8 ± 19.4/89.2 ± 12.0 mmHg; P = 0.013). We also observed reductions of both systolic and diastolic BP levels compared to baseline values in immigrants stratified according to residence permit, although without relevant differences among groups. CONCLUSIONS: Beyond conventional risk factors, socio-economic issues, including lack of residence permit or habitation, may affect BP levels and control in frail populations of immigrants, which have been marginally considered before.

Prognostic Value of QFR Measured Immediately After Successful Stent Implantation: The International Multicenter Prospective HAWKEYE Study.

OBJECTIVES: The aim of this study was to investigate the potential role of post-percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) measurements to predict clinical outcomes in patients with successful PCI. BACKGROUND: The prognostic value of QFR measured immediately after PCI has not been prospectively investigated. METHODS: Patients undergoing complete revascularization with successful PCI and stent implantation were eligible for acquisition of projections for QFR computation. At the end of the procedure, 2 angiographic projections for each vessel treated with PCI were acquired. Computation of QFR was performed offline by an independent core laboratory. The primary outcome was the vessel-oriented composite endpoint, defined as vessel-related cardiovascular death, vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. RESULTS: Seven hundred fifty-one vessels in 602 patients were analyzed. The median value of post-PCI QFR was 0.97 (interquartile range: 0.92 to 0.99). Lesion location in the left anterior descending coronary artery, baseline SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score, lesion length, and post-PCI diameter stenosis were found to be predictors of lower post-PCI QFR. Altogether, 77 events were detected in 53 treated vessels (7%). Post-PCI QFR was significantly lower in vessels with the vessel-oriented composite endpoint during follow-up, compared with those without it (0.88 [interquartile range: 0.81 to 0.99] vs. 0.97 [interquartile range: 0.93 to 0.99], respectively; p < 0.001). Receiver-operating characteristic curve analysis identified a post-PCI QFR best cutoff of ≤0.89 (area under the curve 0.77; 95% confidence interval: 0.74 to 0.80; p < 0.001). After correction for potential confounding factors, post-PCI QFR ≤0.89 was associated with a 3-fold increase in risk for the vessel-oriented composite endpoint (hazard ratio: 2.91; 95% confidence interval: 1.63 to 5.19; p < 0.001). CONCLUSIONS: Lower values of QFR after complete and successful revascularization predict subsequent adverse events (Angio-Based Fractional Flow Reserve to Predict Adverse Events After Stent Implantation [HAWKEYE]; NCT02811796).

[Global health and proximity: a framework for strategies of access to healthcare by hard-to-reach groups.] / Salute globale e prossimità: un framework per le strategie di accesso all'assistenza sanitaria da parte dei gruppi hard-to-reach.

The debate on strategies for protecting migrant health has taken shape in recent years around the crucial issue of accessibility. The epistemological framework for this question is found in the systemic vision of global health, in which proximity emerges as an ethical-practical dimension that must inform public health programs. From an operational perspective, starting from experience gained and the literature, some strategies have emerged, centred on networks, which we propose to define in terms of "proximity public health" (PPH). This definition refers to the complex of relations between public institutions, private social organizations and communities present in a given territory, aimed at promoting access to prevention and care resources through the active provision of healthcare outside clinical settings (outreach), the reorientation of healthcare services with a view to greater permeability and usability (system mediation) and the involvement of the population in empowerment processes.

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.

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.

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.

A Prospective Evaluation of a Pre-Specified Absorb BVS Implantation Strategy in ST-Segment Elevation Myocardial Infarction: The BVS STEMI STRATEGY-IT Study.

OBJECTIVES: The aim of this study was to assess the feasibility and clinical results following a pre-specified bioresorbable scaffold (Absorb BVS) implantation strategy in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Concerns were raised about the safety of Absorb because a non-negligible rate of thrombosis was reported within 30 days and at midterm follow-up after primary percutaneous coronary intervention. METHODS: This was a prospective, multicenter study of patients with STEMI (<75 years of age with symptom onset <12 h) undergoing primary percutaneous coronary intervention with Absorb following a dedicated implantation protocol. The primary endpoint was a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization within 30 days. RESULTS: During the study period, 505 patients with STEMI (16.9% of the overall STEMI population) were treated with the Absorb BVS. The mean age was 56.6 ± 9.4 years, and 487 patients (96.4%) were in Killip class I or II at admission. According to the study protocol, direct Absorb implantation was feasible in 47 patients (9.3%), whereas post-dilatation was performed in 468 cases (92.7%). Procedural success was attained in 94.8% of the cases. Dual antiplatelet therapy with ticagrelor or prasugrel was administered at discharge in 481 patients (95.1%). At 30-day follow-up, the hierarchical device-oriented composite endpoint rate was 0.6% (0.4% cardiac death, 0.2% target vessel myocardial infarction and ischemia-driven target lesion revascularization). One episode (0.2%) of probable scaffold thrombosis was reported. CONCLUSIONS: A pre-specified Absorb implantation strategy in real-world patients with STEMI undergoing primary percutaneous coronary intervention was feasible and associated with a low 30-day device-oriented composite endpoint rate. Mid- and long-term follow-up is strongly needed to eventually confirm these early results. (Use of BVS in ST-Segment Elevation Myocardial Infarction [STEMI]: The BVS STEMI STRATEGY-IT Prospective Registry [STRATEGY-IT]; NCT02601781).