Risk Factor Analysis for Crossing Failure in Primary Antegrade Wire-Catheter Approach for Femoropopliteal Chronic Total Occlusions

Introduction: Antegrade wire-catheter crossing remains the primary approach for femoropopliteal interventions. Nonetheless, data reporting on crossing failure are limited. Aim of this study is to identify risk factors for antegrade crossing failure in patients with femoropopliteal chronic total occlusions (CTOs). Methods: This is a single-center, retrospective analysis. Patients with femoropopliteal CTOs treated between May 2018 and February 2020 were included into this study. Primary endpoint of this analysis was primary crossing success defined as successful antegrade crossing without the use of retrograde access, crossing or re-entry devices. The assisted crossing success was additionally analyzed. A logistic regression analysis identified risk factors for failed primary antegrade crossing. Results: Data from 300 patients were analyzed. The majority (n=183, 61%) presented with lifestyle limiting claudication. The mean lesion length was 180 mm [interquartile range (IQR) 100–260 mm], whereas the median CTO length was 100 mm (IQR=50–210 mm). A chronic total occlusion crossing approach based on plaque morphology (CTOP) type I configuration was observed in 9% (n=26) of the lesions, type II in 61% (n=183), type III in 8% (n=25), and type IV in 66 CTOs (n= 66, 22%). Severe calcification based on the Peripheral Arterial Calcium Scoring Scale (PACSS), Peripheral Academic Research Consortium (PARC), and 360° grading systems was identified in 17%, 24%, and 28% of the lesions, respectively. A contralateral femoral access was used in 278 cases (93%). The primary crossing success amounted to 70% (n=210). The use of a re-entry device in 28 patients (9%) or of a combined antegrade–retrograde approach in 11% (n=34) of the cases increased the assisted crossing success to 89% (n=267). The presence of calcification (odds ratio [OR]=4.2, 95% CI=1.7–10.2) or of circumferential calcium (OR=2.5, 95% CI=1.3–4.9), a CTOP class ΙΙΙ or ΙV (OR=1.9, 95% CI=1.4–2.6), a proximal superficial femoral artery (SFA) occlusion (OR=3.5, 95% CI=1.7–7.4) and a CTO at P3 (OR=4.1, 95% CI=1.5–10.8) were associated with an increased risk for antegrade crossing failure. Conclusions: In this study, chronic total occlusions (CTO) morphology, calcification burden, and lesion’s location were identified as independent risk factors for failed antegrade crossing. Nonetheless, the use of alternative crossing strategies significantly increased the overall crossing success

Burden of Stroke in Europe: An Analysis of the Global Burden of Disease Study Findings From 2010 to 2019

BACKGROUND: While most European Regions perform well in global comparisons, large discrepancies within stroke epidemiological parameters exist across Europe. The objective of this analysis was to evaluate the stroke burden across European regions and countries in 2019 and its difference to 2010. METHODS: The GBD 2019 analytical tools were used to evaluate regional and country-specific estimates of incidence, prevalence, deaths, and disability-adjusted life years of stroke for the European Region as defined by the World Health Organization, with its 53 member countries (EU-53) and for European Union as defined in 2019, with its 28 member countries (EU-28), between 2010 and 2019. Results were analyzed at a regional, subregional, and country level. RESULTS: In EU-53, the absolute number of incident and prevalent strokes increased by 2% (uncertainty interval [UI], 0%–4%), from 1 767 280 to 1 802 559 new cases, and by 4% (UI, 3%–5%) between 2010 and 2019, respectively. In EU-28, the absolute number of prevalent strokes and stroke-related deaths increased by 4% (UI, 2%–5%) and by 6% (UI, 1%–10%), respectively. All-stroke age-standardized mortality rates, however, decreased by 18% (UI, −22% to −14%), from 82 to 67 per 100 000 people in the EU-53, and by 15% (UI, −18% to −11%), from 49.3 to 42.0 per 100 000 people in EU-28. Despite most countries presenting reductions in age-adjusted incidence, prevalence, mortality, and disability-adjusted life year rates, these rates remained 1.4×, 1.2×, 1.6×, and 1.7× higher in EU-53 in comparison to the EU-28. CONCLUSIONS: EU-53 showed a 2% increase in incident strokes, while they remained stable in EU-28. Age-standardized rates were consistently lower for all-stroke burden parameters in EU-28 in comparison to EU-53, and huge discrepancies in incidence, prevalence, mortality, and disability-adjusted life-year rates were observed between individual countries

Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort

Purpose:To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.govidentifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease.Materials and Methods:The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09 +/- 9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee.Results:The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank pPeer reviewe

Three-year sustained clinical efficacy of drug-coated balloon angioplasty in a real-world femoropopliteal cohort

Purpose:To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.govidentifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease.Materials and Methods:The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09 +/- 9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee.Results:The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter <= 4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia.Conclusion:DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure

Efficacy of a Drug-Eluting Stent Versus Bare Metal Stents for Symptomatic Femoropopliteal Peripheral Artery Disease: Primary Results of the EMINENT Randomized Trial.

BACKGROUND A clear patency benefit of a drug-eluting stent (DES) over a bare metal stent (BMS) for treating peripheral artery disease of the femoropopliteal segment has not been definitively demonstrated. The EMINENT study (Trial Comparing Eluvia Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery) was designed to evaluate the patency of the Eluvia DES (Boston Scientific, Marlborough, MA), a polymer-coated paclitaxel-eluting stent, compared with BMS for the treatment of femoropopliteal artery lesions. METHODS EMINENT is a prospective, randomized, controlled, multicenter European study with blinded participants and outcome assessment. Patients with symptomatic peripheral artery disease (Rutherford category 2, 3, or 4) of the native superficial femoral artery or proximal popliteal artery with stenosis ≥70%, vessel diameter of 4 to 6 mm, and total lesion length of 30 to 210 mm were randomly assigned 2:1 to treatment with DES or BMS. The primary effectiveness outcome was primary patency at 12 months, defined as independent core laboratory-assessed duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion. Primary sustained clinical improvement was a secondary outcome defined as a decrease in Rutherford classification of ≥1 categories compared with baseline without a repeat velocity ratio ≤2.4 in the absence of clinically driven target lesion revascularization. Health-related quality of life and walking function were assessed. RESULTS A total of 775 patients were randomly assigned to treatment with DES (n=508) or commercially available BMS (n=267). Baseline clinical, demographic, and lesion characteristics were similar between the study groups. Mean lesion length was 75.6±50.3 and 72.2±47.0 mm in the DES and BMS groups, respectively. The 12-month incidence of primary patency for DES treatment (83.2% [337 of 405]) was significantly greater than for BMS (74.3% [165 of 222]; P<0.01). Incidence of primary sustained clinical improvement was greater among patients treated with the DES than among those who received a BMS (83.0% versus 76.6%; P=0.045). The health-related quality of life dimensions of mobility and pain/discomfort improved for the majority of patients in both groups (for 66.4% and 53.6% of DES-treated and for 64.2% and 58.1% of BMS-treated patients, respectively) but did not differ significantly. At 12 months, no statistical difference was observed in all-cause mortality between patients treated with the DES or BMS (2.7% [13 of 474] versus 1.1% [3 of 263]; relative risk, 2.4 [95% CI, 0.69-8.36]; P=0.15). CONCLUSIONS By demonstrating superior 1-year primary patency, the results of the EMINENT randomized study support the benefit of using a polymer-based paclitaxel-eluting stent as a first-line stent-based intervention for patients with symptomatic peripheral artery disease attributable to femoropopliteal disease. REGISTRATION URL: https://www. CLINICALTRIALS gov; Unique identifier: NCT02921230

Burden of Stroke in Europe:An Analysis of the Global Burden of Disease Study Findings From 2010 to 2019

BACKGROUND:While most European Regions perform well in global comparisons, large discrepancies within stroke epidemiological parameters exist across Europe. The objective of this analysis was to evaluate the stroke burden across European regions and countries in 2019 and its difference to 2010.METHODS:The GBD 2019 analytical tools were used to evaluate regional and country-specific estimates of incidence, prevalence, deaths, and disability-adjusted life years of stroke for the European Region as defined by the World Health Organization, with its 53 member countries (EU-53) and for European Union as defined in 2019, with its 28 member countries (EU-28), between 2010 and 2019. Results were analyzed at a regional, subregional, and country level.RESULTS:In EU-53, the absolute number of incident and prevalent strokes increased by 2% (uncertainty interval [UI], 0%–4%), from 1 767 280 to 1 802 559 new cases, and by 4% (UI, 3%–5%) between 2010 and 2019, respectively. In EU-28, the absolute number of prevalent strokes and stroke-related deaths increased by 4% (UI, 2%–5%) and by 6% (UI, 1%–10%), respectively. All-stroke age-standardized mortality rates, however, decreased by 18% (UI, −22% to −14%), from 82 to 67 per 100 000 people in the EU-53, and by 15% (UI, −18% to −11%), from 49.3 to 42.0 per 100 000 people in EU-28. Despite most countries presenting reductions in age-adjusted incidence, prevalence, mortality, and disability-adjusted life year rates, these rates remained 1.4×, 1.2×, 1.6×, and 1.7× higher in EU-53 in comparison to the EU-28.CONCLUSIONS:EU-53 showed a 2% increase in incident strokes, while they remained stable in EU-28. Age-standardized rates were consistently lower for all-stroke burden parameters in EU-28 in comparison to EU-53, and huge discrepancies in incidence, prevalence, mortality, and disability-adjusted life-year rates were observed between individual countries.<br/

Σύσταση και λειτουργία πανευρωπαϊκού δικτύου κέντρων αριστείας (centers of excellence) στη βαριατρική χειρουργική

Despite the worldwide acceptance of quality accreditation, the introduction of quality management systems in medical services provision has not yet been adequately codified and disseminated.The prime aim of this thesis is to analyze the consequences of setting up and running a Pan-European Network of Centers of Excellence in Bariatric Surgery in the basis of the dissemination of quality accreditation standards in health service provision and the acceptance of the need for accreditation in health services provision. Secondly, issues relating to the availability and dissemination of quality accreditation standards in health and the benefits received by patients, hospitals and health systems by health services accreditation are analyzed.At the beginning, the study reviews the basics in quality accreditation in health services provision, as well as, the most widespread quality management systems in health services provision.The paper then focuses on quality accreditation in Bariatric Surgery, as in the field of Bariatric Surgery there exists an accreditation council which provides quality accreditation in the United States of America (USA), European Union (EU), Arab countries and Africa. The “Centers of Excellence” Program (CoE) was initiated in the area of Europe, Middle East and Africa by the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). Th major aim of the “Centers of Excellence” concept is to describe the requirement for improvement of the management offered to morbidly obese patients. Surgeon’s experience, volume of patients treated per year, institutional equipment, facilities and services are of the outmost importance for safe and effective treatment of the morbidly obese patients. The structure of the “Centers of Excellence” Program certification procedure is presented, while the standard’s requirements are summarized. Subsequently, study reviews retrospectively the reported data from participating institutions at IFSO’s CoE program and compares the two most commonly used bariatric operations, Roux-en-Y gastric bypass and sleeve gastrectomy. The study proves that hospitals and surgeons accredited by EAC-BS in Bariatric Surgery, implemented sleeve gastrectomy and gastric bypass with maximum safety and the best possible outcome for the patients.Παρά τη μεγάλη διάδοση και εφαρμογή προτύπων διαπίστευσης και πιστοποίησης της ποιότητας και την παγκόσμια αποδοχή τους, η εισαγωγή συστημάτων διαχείρισης της ποιότητας στους δημόσιους και ιδιωτικούς οργανισμούς παροχής υπηρεσιών υγείας ως προς τις παρεχόμενες ιατρικές υπηρεσίες τους δεν έχει έως και σήμερα επαρκώς κωδικοποιηθεί και διαδοθεί. Αντικείμενο της διπλωματικής εργασίας είναι η διερεύνηση των συνεπειών της σύστασης και λειτουργίας ενός Πανευρωπαϊκού δικτύου Κέντρων Αριστείας στην Βαριατρική Χειρουργική ως προς τη διάδοση προτύπων πιστοποίησής της ποιότητας σε οργανισμούς παροχής υπηρεσιών υγείας, και ως προς την αποδοχή της αναγκαιότητας διαπίστευσης των υπηρεσιών υγείας. Δευτερευόντως, εξετάζονται ζητήματα που αφορούν τη διαθεσιμότητα και διάδοση προτύπων πιστοποίησής της ποιότητας στην υγεία και των ωφελημάτων που εισπράττουν οι ασθενείς, τα νοσηλευτικά ιδρύματα και τα συστήματα υγείας από την πιστοποίηση των υπηρεσιών υγείας. Στην αρχή της εργασίας γίνεται μια εισαγωγή για την έννοια και τον ορισμό της ποιότητας στην υγεία καθώς και για τα ποιο διαδεδομένα συστήματα διαχείρισης ποιότητας στις υπηρεσίες υγείας. Εν συνεχεία η εργασία επικεντρώνεται στη διαπίστευση της ποιότητας στη Βαριατρική Χειρουργική, καθώς στο πεδίο της Βαριατρική Χειρουργικής υφίσταται πρότυπο διαπίστευσης της ποιότητας των παρεχόμενων ιατρικών υπηρεσιών σε Ηνωμένες Πολιτείες Αμερικής (ΗΠΑ), Ευρωπαϊκή Ένωση (ΕΕ), Αραβικές Χώρες και Αφρική. Η μελέτη εστιάζει στην διερεύνηση του προτύπου «Κέντρα Αριστείας» που παρέχεται από το European Accreditation Council for Bariatric Surgery (EAC-BS) στην Ευρωπαϊκή Ένωση, Αφρική και τις Αραβικές Χώρες. Παρουσιάζεται η δομή του προτύπου ενώ γίνεται και περιληπτική αναφορά στις απαιτήσεις του προτύπου. Επιπλέον, περιγράφεται η διαδικασία που πρέπει να ακολουθήσουν τα νοσηλευτικά ιδρύματα και οι ιατροί για να πιστοποιηθούν. Ακολούθως, αξιολογούνται συγκριτικά τα στοιχεία του αρχείου του EAC-BS για δύο βασικές τεχνικές βαριατρικής χειρουργικής την επιμήκη γαστρεκτομή (sleeve gastrectomy) και την γαστρική παράκαμψη (gastric bypass). Από την συγκριτική αξιολόγηση των αποτελεσμάτων της επιμήκους γαστρεκτομής (sleeve gastrectomy) και της γαστρικής παράκαμψης (gastric bypass) αποδεικνύεται αφενός ότι τα νοσηλευτικά ιδρύματα και οι χειρουργοί που πληρούν τα κριτήρια ασφάλειας του International Federation for the Surgery of Obesity (IFSO) και έχουν πιστοποιηθεί από τον EAC-BS για την εφαρμογή Συστήματος Διαχείρισης Ποιότητας (ΣΔΠ) στη Βαριατρική Χειρουργική, εφαρμόζουν τις δύο παραπάνω βασικές τεχνικές βαριατρικής χειρουργικής με τη μέγιστη δυνατή ασφάλεια και το βέλτιστο δυνατό αποτέλεσμα για τον ασθενή. Επιπρόσθετα, προκύπτει η βέλτιστη συγκριτικά τεχνική σε σχέση με την ικανοποίηση των απαιτήσεων των ασθενών και την βελτίωση της ποιότητας της ζωής τους