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The optimal duration of dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) with implantation of the Orsiro Mission stent remains unclear. The BIOFLOW-DAPT (clinicaltrials.gov, NCT04137510) trial is a prospective, multi-center, randomized controlled study designed to assess the safety of the Orsiro Mission versus the Resolute Onyx stent in HBR patients. Patients are treated with DAPT (aspirin and a P2Y12 inhibitor) for 1 month, followed by a single antiplatelet therapy (SAPT). The primary endpoint is the composite of cardiac death, myocardial infarction, and definite or probable stent thrombosis at 1 year. With a final sample size of 1948 HBR patients, this study is powered to assess the noninferiority of the Orsiro Mission stent with respect to the primary study endpoint. The BIOFLOW-DAPT is the first randomized clinical trial investigating 1-month DAPT duration in HBR patients after implantation of the Orsiro Mission stent. Trial Registration: ClinicalTrials.gov number, NCT04137510 Study design and key features. Patient selection starts before the index PCI, when consented patients will be randomized to the Orsiro Mission or the Resolute Onyx stent with mandated 1-month DAPT. At 1 month, eligibility is reassessed and if met, patients will discontinue DAPT and continue with P2Y12 inhibitor or aspirin monotherapy. PCI, percutaneous coronary intervention; DAPT, dual antiplatelet therapy; DES, drug-eluting stent; HBR, high bleeding risk; P2Y12i, P2Y12 inhibitor; ST, stent thrombosis [ABSTRACT FROM AUTHOR]

To chart the evolution of the CTO-PCI landscape in Belgium and Luxembourg, the Belgian Working Group on Chronic Total Occlusions (BWGCTO) was established in 2016. Between May 2016 and December 2019, patients undergoing a CTO-PCI treatment were prospectively and consecutively enrolled. Twenty-one centres in Belgium and one in Luxembourg participated. Individual operators had mixed levels of expertise in treating CTO lesions. Demographic, angiographic, procedural parameters and incidence of major adverse cardiac and cerebrovascular events (MACCE) were systematically registered. Over a four-year enrolment period, 1832 procedures were performed in 1733 patients achieving technical success in 1474 cases (80%), with an in-hospital MACCE rate of 2.3%. Fifty-nine (3%) cases were re-attempt procedures of which 41 (69%) were successful. High-volume centres treated more complex lesions (mean J-CTO score: 2.15 ± 1.21) as compared to intermediate (mean J-CTO score: 1.72 ± 1.23; p < 0.001) and low-volume centres (mean J-CTO score: 0.99 ± 1.21; p = 0.002). Despite this, success rates did not differ between centres (p = 0.461). Overall success rates did not differ over time (p = 0.810). High-volume centres progressively tackled more complex CTOs while keeping success rates stable. In all centres, the most applied strategy was antegrade wire escalation (83%). High-volume centres more often successfully applied antegrade dissection and re-entry and retrograde techniques in lesions with higher complexity. With variable experience levels, operators treated CTOs with high success and relatively few complications. Although AWE remains the most used technique, it is paramount for operators to be skilled in all contemporary techniques in order to be successful in more complex CTOs. [ABSTRACT FROM AUTHOR]

The current study assessed the impact of COVID-19-related public containment measures (i.e. lockdown) on the ST elevation myocardial infarction (STEMI) epidemic in Belgium. Clinical characteristics, reperfusion therapy modalities, COVID-19 status and in-hospital mortality of consecutive STEMI patients who were admitted to Belgian hospitals for percutaneous coronary intervention (PCI) were recorded during a three-week period starting at the beginning of the lockdown period on 13 March 2020. Similar data were collected for the same time period for 2017–2019. An evaluation of air quality revealed a 32% decrease in ambient NO2 concentrations during lockdown (19.5 µg/m³ versus 13.2 µg/m³, p <.001). During the three-week period, there were 188 STEMI patients admitted for PCI during the lockdown versus an average 254 STEMI patients before the lockdown period (incidence rate ratio = 0.74, p =.001). Reperfusion strategy was predominantly primary PCI in both time periods (96% versus 95%). However, there was a significant delay in treatment during the lockdown period, with more late presentations (>12 h after onset of pain) (14% versus 7.6%, p =.04) and with longer door-to-balloon times (median of 45 versus 39 min, p =.02). Although the in-hospital mortality between the two periods was comparable (5.9% versus 6.7%), 5 of the 7 (71%) COVID-19-positive STEMI patients died. The present study revealed a 26% reduction in STEMI admissions and a delay in treatment of STEMI patients. Less exposure to external STEMI triggers (such as ambient air pollution) and/or reluctance to seek medical care are possible explanations of this observation. [ABSTRACT FROM AUTHOR]

The radiation exposure in the cath lab of patients, cardiologists, and nurses was measured during three consecutive periods of 8 weeks. The first 8 weeks the baseline radiation exposure was obtained. In the second period standard incidences for coronarography and frame rate were changed, without compromising the image quality of the examination. In the third period, a pelvic shield covered the lower part of the patient. This pilot quality project demonstrates that further significant reduction in radiation exposure of 37% is possible for patients. A significant reduction in radiation exposure of 53 and 62% was obtained among cardiologists and nurses working in the cath lab, even with the already diminished radiation exposure over the last years by better equipment and general radioprotection measures. [ABSTRACT FROM AUTHOR]

Background: Important developments in materials, devices, and techniques have improved outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI), and resulted in a growing interest in CTO-PCI. The Belgian Working Group on Chronic Total Occlusions (BWGCTO) working group aims to assess the evolution within the CTO-PCI landscape over the next years. Methods: From May 2016 onwards, patients undergoing CTO-PCI were included in the BWGCTO registry by 15 centres in Belgium and Luxemburg. Baseline, angiographic, and procedural data were collected. Here, we report on the one-year in-hospital outcomes. Results: Over the course of one year, 411 procedures in 388 patients were included with a mean age of 64 ± 11 years. The majority were male (81%). Relatively complex CTOs were treated (Japanese CTO score =2.2 ± 1.2) with a high procedure success rate (82%). Patient- and lesion-wise success rates were 83 and 85%, respectively. Major adverse in-hospital events were acceptably low (3.4%). Antegrade wire escalation technique was applied most frequently (82%). On the other hand, antegrade dissection and re-entry and retrograde strategies were more frequently applied in higher volume centres and successful for lesions with higher complexity. Conclusion: Satisfactory procedural outcomes and a low rate of adverse events were obtained in a complex CTO population, treated by operators with variable experience levels. Antegrade wire escalation was the preferred strategy, regardless of operator volume. [ABSTRACT FROM AUTHOR]

Aims Literature suggests a beneficial effect of percutaneous left atrial appendage occlusion (LAAO) to prevent thrombo-embolic events in patients with non-rheumatic atrial fibrillation (AF). We compared outcome of LAAO versus 'suboptimal standard' treatment in AF patients with high bleeding risk. Methods and results Patients with sufficient follow-up data (n = 125) who underwent LAAO with the Amplatzer Cardiac Plug (ACP) were selected from the Belgian ACP database. AF patients who survived intracranial haemorrhage were recruited from the Leuven Neurosurgical Registry (LNR, n = 113). After propensity score adjustment, the outcome of both groups was compared for the combined end point (death, stroke, transient ischaemic attack, systemic emboli, and major bleeding event). The LAAO group did not differ from the LNR group for mean age and gender (74 ± 7 versus 75 ± 10 years, P = 0.29; female 39% versus 48%, P = 0.18). However, the CHA2DS2-VASc and HAS-BLED scores were both higher in the LAAO group (4.8 ± 1.7 versus 3.9 ± 1.7, P = 0.0001; 3.5 ± 1.4 versus 3.2 ± 1.4, P = 0.036). After propensity score adjustment, the risk for the primary end point was significantly higher for the LNR group (HR 2.012, 95% CI 1.113-3.638). Conclusion LAAO with ACP seems to improve the combination of survival and the prevention of thrombo-embolic and major bleeding events in patients with atrial fibrillation and increased bleeding risk. [ABSTRACT FROM AUTHOR]

Aims The aim of the present study was to evaluate the procedural feasibility, the safety and the l-year outcome following left atrial appendage (LAA) closure using the Amplatzer cardiac plug (ACP) in Belgium. Methods and results Data were prospectively collected among 90 consecutive patients, undergoing LAA closure with an ACP in 7 Belgian centres between June 2009 and September 2012. The patients (56 males, 74± 8 years) were at high risk for stroke (CHA2DS2-VASc = 4.4± 13) and bleeding (HAS-BLED = 3.3 ± 1.3). Technical success was obtained in all but one patient and procedural success was 95%. Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case. Minor complications were 3 insignificant pericardial effusions, 2 transient myocardial ischaemia due to air embolism and I femoral pseudoaneurysm. At 1-y follow-up, there were 4 deaths, 2 minor strokes, I tam ponade and I myocardial infarction. Overall survival was 94% and freedom from MAE was 88%. In our population, the expected annual stroke risk according to the CHA2DS2-VASc score was 5.08%, while the observed stroke rate was 2.14%/year. Conclusions The Belgian registry shows that LAA closure using the ACP device is feasible and safe. At 1-y follow-up, the observed stroke rate was Z14%/year, less than predicted by the CHA2DS2-VASc score. Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke. [ABSTRACT FROM AUTHOR]