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OBJECTIVES: To describe imaging assessment, procedural and follow-up outcome of patients undergoing left atrial appendage (LAA) occlusion (LAAO) using a "sandwich" technique.BACKGROUND: The presence of a LAA with chicken wing morphology constitutes a challenge that sometimes requires specific occlusion strategies like the "sandwich" technique. However, procedural and follow-up data focusing on this implanting strategy is scarce.METHODS: This multicenter study collected individual data from eight centers between 2012 and 2019. Consecutive patients with chicken-wing LAAs defined as an early (90°) who underwent LAAO with Amplatzer devices and using the "sandwich" technique were included in the analysis.RESULTS: Overall, 190 subjects were enrolled in the study. Procedures were done with the Amulet device (85%) and the Amplatzer Cardiac Plug (15%). Successful implantation was achieved in 99.5% with ≤1 partial recapture in 80% of cases. Single (46.2%) and dual antiplatelet therapy (39.4%) were the most used antithrombotic therapies after LAAO. In-hospital major adverse events rate was 1.5% with no deaths. One patient (0.5%) had cardiac tamponade requiring percutaneous drainage. With a mean follow-up of 19.6 ± 14.8 months, the mortality and stroke rates were 7.7%/year and 2.5%/year, respectively. Follow-up transesophageal echocardiography (TEE) at 2-3 months showed device-related thrombosis in 2.8% and peri-device leak ≥3 mm in 1.2% of patients.CONCLUSIONS: In a large series of patients with chicken wing LAA anatomies undergoing LAAO, the use of the "sandwich" technique was feasible and safe. Preprocedural imaging was a key-factor to determine specific measurements.

Background: Event adjudication by a clinical event committee (CEC) provides a standardized, independent outcome assessment. However, the added value of CEC to investigators reporting remains debated. GLASSY (GLOBAL LEADERS Adjudication Sub-Study) implemented, in a subset of the open-label, investigator-reported (IR) GLOBAL LEADERS trial, an independent adjudication process of reported and unreported potential outcome events (triggers). We describe metrics of GLASSY feasibility and efficiency, diagnostic accuracy of IR events, and their concordance with corresponding CEC-adjudicated events. Methods: We report the proportion of myocardial infarction, bleeding, stroke, and stent thrombosis triggers with sufficient evidence for assessment (feasibility) that were adjudicated as outcome events (efficiency), stratified by source (IR or non-IR). Using CEC-adjudicated events as criterion standard, we describe sensitivity, specificity, positive and negative predictive value, and global diagnostic accuracy of IR events. Using Gwet AC coefficient, we examine the concordance between IR- and corresponding CEC-adjudicated triggers. There was sufficient evidence for assessment for 2592 (98.3%) of 2636 triggers. Results: Overall, the adjudicated end point-to-trigger ratio was high and similar between IR- (88%) and non-IR–reported (87%) triggers. The global diagnostic accuracy and concordance between IR-reported and CEC-adjudicated outcome events was 0.70 (95% CI, 0.65–0.74) and 0.54 (95% CI, 0.45–0.62), respectively, for myocardial infarction; 0.77 (95% CI, 0.75–0.79) and 0.71 (95% CI, 0.68–0.74) for bleeding; 0.70 (95% CI, 0.62–0.79) and 0.59 (95% CI, 0.43–0.74) for stroke; 0.59 (95% CI, 0.52–0.66) and 0.39 (95% CI, 0.25–0.53) for stent thrombosis. For IR bleedings, the concordance with the CEC on type of events was generally weak. Conclusions: Implementing CEC adjudication in a pragmatic open-label trial with IR events is feasible and efficient. Our findings of modest global diagnostic accuracy for IR events and generally weak concordance between investigators and CEC support the role for CEC adjudication in such settings. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03231059.

Objectives To compare 2-year outcome following treatment with drug-eluting stents (DES) for acute myocardial infarction (MI) versus non-MI clinical syndromes. In acute MI patients, a stent-level comparison was performed, comparing Resolute Onyx versus Orsiro stents.Background In patients presenting with acute MI, higher adverse event rates have been reported. So far, no clinical results >1 year have been published of acute MI patients treated with Resolute Onyx.Methods This post-hoc analysis of the randomized BIONYX trial(NCT02508714) assessed the main outcome target vessel failure (TVF: cardiac death, target vessel MI, or target vessel revascularization) with Kaplan-Meier methods.Results Of all 2,488 trial participants, acute MI patients (n = 1,275[51.2%]) were significantly younger and had less comorbidities than non-MI patients (n = 1,213[48.8%]). TVF rates were lower in acute MI patients (77/1,275[6.1%] vs. 103/1,213[8.6%], HR:0.70, 95%-CI 0.52-0.94; p(log-rank) = 0.02), mainly driven by target vessel revascularization (4.1 vs. 6.1%, p(log-rank) = 0.03). Multivariate analysis showed no independent association of clinical syndrome with TVF (adjusted-HR: 0.81, 95%-CI 0.60-1.10; p = .17). In MI patients treated with Resolute Onyx (n = 626) versus Orsiro (n = 649), there was no difference in TVF (6.2 vs. 6.1%; p(log-rank) = 0.97) and its components. There was only 1(0.2%) definite-or-probable stent thrombosis in RO-ZES and 8(1.2%) in O-SES (p = .053).Conclusions Two years after treatment with thin-strut DES in this randomized trial, patients treated for acute MI had lower adverse event rates than non-MI patients. Yet, these findings were mainly attributable to between-group differences in patient and lesion characteristics. In patients who underwent PCI for acute MI, both Resolute Onyx and Orsiro showed favorable and similar 2-year outcomes. Biotronik; Medtronic

BACKGROUND Although the presence of a thrombus contraindicates left atrial appendage closure procedure (LAAC), a previous study reported the feasibility of the thrombus trapping procedure (TTP) technique to overcome this limitation. AIMS This study aimed to analyse the short-term outcomes in a series of patients who underwent LAAC using the TTP (TTP-LAAC). METHODS This retrospective series included patients who underwent TTP-LAAC between January 2018 and May 2020 in 13 European centres. Device choice, pre-interventional work-up and post-discharge antithrombotic therapy regimens were left to the discretion of the operators. The primary endpoint was the 30-day occurrence of stroke, systemic embolism or cardiovascular death. RESULTS During the study period, a total of 1,918 patients underwent LAAC. A thrombus was identified in 71 cases but completely disappeared in 24 patients before procedure. TTP-LAAC was finally performed in 53 cases (3%). Thrombi were identified ahead of the actual day of implantation in 47 patients (87 %) and were mostly limited in size (50 cases with extension

Background: Radial artery access has been shown to reduce mortality and bleeding events, especially in patients with acute coronary syndromes. Despite this, interventional cardiologists experienced in femoral artery access still prefer that route for percutaneous coronary intervention. Little is known regarding the merits of each vascular access in patients stratified by their risk of bleeding. Methods: Patients from the Global Leaders trial were dichotomized into low or high risk of bleeding by the median of the PRECISE-DAPT score. Clinical outcomes were compared at 30 days. Results: In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.42-1.15). Radial access was associated with a significantly lower rate of the secondary safety end point, Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding (HR 0.55, 95% CI 0.36-0.84). Compared by bleeding risk strata, in the high bleeding score population, the primary (HR 0.47, 95% CI 0.26-0.85; P = 0.012; Pinteraction = 0.019) and secondary safety (HR 0.57, 95% CI 0.35-0.95; P = 0.030; Pinteraction = 0.631) end points favoured radial access. In the low bleeding score population, however, the differences in the primary and secondary safety end points between radial and femoral artery access were no longer statistically significant. Conclusions: Our findings suggest that the outcomes of mortality or new Q-wave MI and BARC 3 or 5 bleeding favour radial access in patients with a high, but not those with a low, risk of bleeding. Because this was not a primary analysis, it should be considered hypothesis generating.

Residual or newly acquired leaks are routinely appraised after left atrial appendage closure (LAAC). The Watchman and the Amulet are the two most frequently used devices for LAAC but no randomized study has so far assessed their comparative leak rates after intervention. The "Comparison of Amplatzer Amulet vs Watchman devices in patients undergoing left atrial appendage closure" (Swiss-Apero, clinicaltrial.gov NCT03399851) is an academic-sponsored multicenter, randomized clinical trial comparing Amulet versus Watchman/FLX devices among patients undergoing a clinically indicated LAAC. The study is designed to assess the superiority of Amulet vs. Watchman/FLX in terms of leaks detected by cardiac computed tomography angiography (CCTA) at 45 days (primary endpoint) and 13 months (secondary endpoint) after intervention by an imaging Core Laboratory. The Swiss-Apero study is the first randomized clinical trial comparing Amulet and Watchman/FLX with respect to the prevalence of post-procedural leak as assessed with CCTA.

Background:No study has so far compared Amulet with the new Watchman FLX in terms of residual left atrial appendage (LAA) patency or clinical outcomes in patients undergoing percutaneous LAA closure.Methods:In the investigator-initiated SWISS APERO trial (Comparison of Amulet Versus Watchman/FLX Device in Patients Undergoing Left Atrial Appendage Closure), patients undergoing LAA closure were randomly assigned (1:1) open label to receive Amulet or Watchman 2.5 or FLX (Watchman) across 8 European centers. The primary end point was the composite of justified crossover to a nonrandomized device during LAA closure procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA) at 45 days. The secondary end points included procedural complications, device-related thrombus, peridevice leak at transesophageal echocardiography, and clinical outcomes at 45 days.Results:Between June 2018 and May 2021, 221 patients were randomly assigned to Amulet (111 [50.2%]) or Watchman (110 [49.8%]), of whom 25 (22.7%) patients included before October 2019 received Watchman 2.5, and 85 (77.3%) patients received Watchman FLX. The primary end point was assessable in 205 (92.8%) patients and occurred in 71 (67.6%) patients receiving Amulet and 70 (70.0%) patients receiving Watchman, respectively (risk ratio, 0.97 [95% CI, 0.80–1.16];P=0.713). A single justified crossover occurred in a patient with Amulet who fulfilled LAA patency criteria at 45-day CCTA. Major procedure-related complications occurred more frequently in the Amulet group (9.0% versus 2.7%;P=0.047) because of more frequent bleeding (7.2% versus 1.8%). At 45 days, the peridevice leak rate at transesophageal echocardiography was higher with Watchman than with Amulet (27.5% versus 13.7%,P=0.020), albeit none was major (ie, >5 mm), whereas device-related thrombus was detected in 1 (0.9%) patient with Amulet and 3 (3.0%) patients with Watchman at CCTA and in 2 (2.1%) and 5 (5.5%) patients at transesophageal echocardiography, respectively. Clinical outcomes at 45 days did not differ between the groups.Conclusions:Amulet was not associated with a lower rate of the composite of crossover or residual LAA patency compared with Watchman at 45-day CCTA. Amulet, however, was associated with lower peridevice leak rates at transesophageal echocardiography, higher procedural complications, and similar clinical outcomes at 45 days compared with Watchman. The clinical relevance of CCTA-detected LAA patency requires further investigation.Registration:URL:https://www.clinicaltrials.gov; Unique identifier: NCT03399851.

Aims Left atrial appendage occlusion (LAAO) may be considered for patients with non-valvular atrial fibrillation (NVAF) and a relative/formal contraindication to anticoagulation. This study aimed to summarize the impact of aging on LAAO outcomes at short and long-term follow-up. Methods and results We compared subjects aged Conclusions Despite the increased risk for ischaemic stroke with increasing age in AF patients, LAAO reduced the risk for ischaemic stroke compared with the predicted rate across all age groups without differences in procedural SAEs.

The coronavirus disease 2019 pandemic is having a major impact on healthcare systems worldwide. Several months after the COVID-19 outbreak, waiting lists of non-urgent structural heart (SH) interventions continue to increase. Limitations in terms of ICU beds and anesthesiology represent a major limitation to conduct non-urgent SH interventions and are a valid reason to move towards less invasive approaches. The field of left atrial appendage occlusion (LAAO) reflects this challenging situation perfectly. The aim of this paper is to describe the possibilities for pre-procedural LAA assessment, performance of the LAAO procedure and post-procedural surveillance in these challenging times.

Background/Introduction The novel thin composite-wire strut zotarolimus-eluting stent (ZES) is a drug-eluting stent that is frequently used for treating patients with obstructive coronary artery disease, but so far no clinical outcome data have been published in patients with diabetes. In all-comer patients, the BIONYX trial (NCT02508714) has established non-inferiority of the ZES versus the ultrathin strut biodegradable-polymer sirolimus-eluting stent (SES) regarding the primary composite endpoint of target vessel failure at 1 year follow-up. Purpose To assess in patients with diabetes, the 2-year safety and efficacy of the current generation thin composite-wire strut ZES, compared to the ultrathin strut SES. Methods In the international, multicentre BIONYX trial, randomisation was stratified for sex and the presence of diabetes mellitus. We performed a prespecified subgroup analysis of patients with diabetes. The main endpoint target vessel failure was a composite of safety and efficacy, consisting of cardiac death, target vessel-related myocardial infarction or clinically indicated target vessel revascularisation. Secondary endpoints, such as target lesion revascularisation and stent thrombosis were also assessed. Results A total of 510/2488 (20.5%) BIONYX trial participants had diabetes, and were therefore included in this analysis. Patients were on average 66.4±10.3 years old, and 28.6% were female. Most participants presented with acute coronary syndromes (65.1%), and 182/510 (35.7%) patients were insulin dependent. Two-year follow up was available in 500 of 510 (98.0%) patients. Target vessel failure occurred in 31/260 (12.2%) patients assigned to ZES versus 26/250 (10.7%) patients assigned to SES (HR 1.14, 95%-CI 0.68–1.92; P-logrank=0.63). Kaplan Meier curves of target vessel failure are displayed in Figure 1. There were no significant between-stent differences in the individual components of this endpoint. Target lesion revascularisation occurred in 15/260 (6.0%) patients treated with ZES versus 9/250 (3.7%) patients treated with SES (HR 1.61, 95%-CI 0.71–3.68; P-logrank=0.25). Definite stent thrombosis was an infrequent event and did not differ significantly between stent-arms (0.4% vs. 1.2%; HR 0.32, 95%-CI 0.03–3.06; P-logrank=0.30). Conclusion In patients with diabetes, the novel thin composite-wire strut durable polymer ZES was similarly safe and efficacious as compared to the ultrathin cobalt-chromium strut biodegradable-polymer SES at 2-year follow-up. Figure1. Target vessel failure at 2 years Funding Acknowledgement Type of funding source: Private company. Main funding source(s): The BIONYX trial was equally funded by Biotronik and Medtronic.

The aim of this clinical study is to assess the feasibility and safety of the 7 Fr Railway sheathless access system (Cordis Corporation) for complex percutaneous coronary interventions (PCI) using distal radial artery access.Over a 2-month period, we enrolled 20 patients (all those undergoing complex PCI) where a 7 Fr guide catheter was deemed necessary. Multiple bifurcation techniques and calcified plaque modifying tools were used. The primary endpoint was procedural success (95%) without need for access-site crossover (0%) or major adverse cardiovascular event within the first month (0%), while our secondary endpoint was the access-site complication rate (arterial spasm in 1 case [5%]).Distal radial access with the 7 Fr Railway sheathless access system was a feasible and safe access option for complex PCI in our very high-risk study population. This approach could be a valuable option for decreasing the risk of a major bleeding event or vascular complication in cases that require a large guide catheter.

Background Patients with diabetes have more extensive coronary disease, resulting in higher risks of adverse clinical events following stenting. In all-comer patients, contemporary DES have shown excellent safety and efficacy, but data on diabetic patients are scarce. Separately for the BIO-RESORT and BIONYX trials, we assessed the 2-year clinical outcomes of diabetic patients, treated with various contemporary drug-eluting stents (DES). Methods We performed two prespecified secondary analyses of two randomized DES trials, which both stratified for diabetes. The main endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. Follow-up was finished before the COVID-19 pandemic. Results In BIO-RESORT, 624/3514 (17.8%) had diabetes: 211 received Orsiro sirolimus-eluting stents (SES), 203 Synergy everolimus-eluting stents (EES), and 210 Resolute Integrity zotarolimus-eluting stents (RI-ZES). TVF did not differ between SES (10.2%) and EES (10.0%) versus RI-ZES (12.7%) (SES vs. RI-ZES HR:0.78, 95%-CI [0.44–1.40]; p = 0.40, EES vs. RI-ZES HR:0.79, 95%-CI [0.44–1.40]; p = 0.42). In BIONYX, 510/2488 (20.5%) patients had diabetes: 250 received SES and 260 Resolute Onyx zotarolimus-eluting stents (RO-ZES). There was no difference in TVF between SES (10.7%) versus RO-ZES (12.2%) (HR:0.88, 95%-CI [0.52–1.48]; p = 0.63). Conclusions There was no difference in 2-year clinical outcome among patients with diabetes, who were treated with SES, or EES, versus RI-ZES. In addition there was no difference in clinical outcome in diabetic patients, who were treated with SES versus RO-ZES. These findings may be considered as a signal of safety and efficacy of the studied DES in patients with diabetes., Graphical abstract Unlabelled Image, Highlights • This is the first report of diabetic patient outcome after PCI with Resolute Onyx. • Resolute Onyx versus Orsiro stents were similarly safe and efficacious at 2 years. • Diabetic patient outcome with Orsiro, Synergy, and Resolute Integrity was similar. • 2-year stent thrombosis rate was low for each device, yet lowest for Resolute Onyx. • Medical therapy and risk factor management may have greater impact than DES choice.

Background 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. Methods 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. Results 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. Conclusion 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.

IntroductionThe radial artery has become the standard access site for percutaneous coronary intervention (PCI) in stable coronary artery disease and acute coronary syndrome, because of less access site related bleeding complications. Patients with complex coronary lesions are under-represented in randomised trials comparing radial with femoral access with regard to safety and efficacy. The femoral artery is currently the most applied access site in patients with complex coronary lesions, especially when large bore guiding catheters are required. With slender technology, transradial PCI may be increasingly applied in patients with complex coronary lesions when large bore guiding catheters are mandatory and might be a safer alternative as compared with the transfemoral approach.Methods and analysisA total of 388 patients undergoing complex PCI will be randomised to radial 7 French access with Terumo Glidesheath Slender (Terumo, Japan) or femoral 7 French access as comparator. The primary outcome is the incidence of the composite end point of clinically relevant access site related bleeding and/or vascular complications requiring intervention. Procedural success and major adverse cardiovascular events up to 1 month will also be compared between both groups.Ethics and disseminationEthical approval for the study was granted by the local Ethics Committee at each recruiting center (‘Medisch Ethische Toetsing Commissie Isala Zwolle’, ‘Commissie voor medische ethiek ZNA’, ‘Comité Medische Ethiek Ziekenhuis Oost-Limburg’, ‘Comité d’éthique CHU-Charleroi-ISPPC’, ‘Commission cantonale d'éthique de la recherche CCER-Republique et Canton de Geneve’, ‘Ethik Kommission de Ärztekammer Nordrhein’ and ‘Riverside Research Ethics Committee’). The trial outcomes will be published in peer-reviewed journals of the concerned literature.Trial registration numberNCT03846752.

PURPOSE: The present paper analyzes the role of different imaging modalities for left atrial appendage (LAA) assessment and the recommended specific measurements to improve device selection with regard to the Amulet device.BACKGROUND: Morphological LAA assessment is one of the pivotal factors to achieve proper LAA sealing and potentially reduce the risk of complications by minimizing manipulation inside the appendage.METHODS: Eight experienced physicians in LAAO were asked to contribute in the preparation of a device sizing consensus manuscript after comprehensive assessment of previous published data on LAA imaging/measurement.RESULTS: LAA morphology is often complex and requires more detailed spatial resolution and 3-dimensional assessments to reduce the risk of mis-sizing. Traditionally, upsizing of devices based upon the largest measured LAA diameters have been used. However, this may lead to oversizing in markedly elliptical appendages. Thus, when 3D imaging modalities are available, utilizing the LAA mean diameters might be a better alternative. Operators should also note the systematic biases in differences in measurements obtained with different imaging modalities, with CT giving the largest measurements, followed by 3D-TEE, and then 2D-TEE and angiography. In fact, for 2D imaging techniques (2D-TEE and angiography), LAA diameters tend to be underestimated, and therefore, LAA largest diameters seem to be still the best option for device sizing. Some specific anatomies such as proximal chicken-wing or conic LAAs may require different measurements and implantations to achieve implant success.CONCLUSIONS: In conclusion, LAA mean diameters might be a better alternative to largest diameters when 3D imaging modalities are available.

Background: polymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited. Methods: in an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority. Results: a total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P = 0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P = 0.007 for noninferiority). Conclusions: among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.).

Summary Background Percutaneous paravalvular leak (PVL) closure has emerged as a palliative alternative to surgical management in selected high-risk patients. Percutaneous procedures are challenging, especially for mitral PVL. Accurate imaging of the morphologies of the defects is mandatory, together with precise guidance in the catheterization laboratory to enhance success rates. Aims To describe imaging modalities used in clinical practice to guide percutaneous PVL closure and assess the potential of new imaging tools. Methods Data from the ‘Fermeture de Fuite paraprothetique’ (FFPP) register were used. The FFPP register is an international multi-institutional collaborative register started in 2017 with a retrospective and a prospective part. A descriptive analysis of multimodality imaging used to guide PVL closure in clinical practice was performed. Results Data from 173 procedures performed in 19 centres from three countries (France, Belgium and Poland) were collected, which included eight cases of PVL following transcatheter valve replacement. Transoesophageal echocardiography was used in 167 cases (96.5%) and 3D echocardiography in 87.4% of cases. In one case, 3D-echocardiography was fused with fluoroscopy images in real time using echonavigator software. Details about multimodality imaging were available from a sample of 31 patients. Cardiac computed tomography (CT) was performed before 10 of the procedures. In one case, fusion between preprocedural cardiac CT angiography data and fluoroscopy data was used. In two cases, a 3D model of the valve with PVL was printed. Conclusion Echocardiography, particularly the 3D mode, is the cornerstone of PVL imaging. Other imaging modalities, such as cardiac CT and cardiac magnetic resonance imaging, may be of complementary interest. New techniques such as imaging fusion and printing may further facilitate the percutaneous approach of PVLs.

Aims: A second iteration of a sirolimus-eluting stent (SES) that has a biodegradable PLGA polymer coating with an electrografting base layer on a thin-strut (80 mu m) cobalt-chromium platform (BuMA Supreme; SINOMED, Tianjin, China) has been developed. This first-in-man trial aimed to assess the efficacy and safety of the novel device.Methods and results: This randomised, multicentre, single-blinded, non-inferiority trial compared the BuMA Supreme SES versus a contemporary durable polymer zotarolimus-eluting stent (ZES) in terms of angiographic in-stent late lumen loss (LLL) at nine-month follow-up as the primary endpoint. A total of 170 patients were randomly allocated to treatment with either SES (n=83) or ZES (n=87). At nine-month angiographic follow-up, in-stent LLL was 0.29 +/- 0.33 mm in the SES group and 0.14 +/- 0.37 mm in the ZES group (p(non-inferiority) = 0.45). The in-stent percent diameter stenosis and the binary restenosis rate of the two treatment arms were similar (19.2 +/- 12.0% vs. 16.1 +/- 12.6%, p=0.09, and 3.3% vs. 4.4%, p=1.00, respectively). At 12-month clinical follow-up, there was no difference between treatment arms with regard to the device-oriented composite clinical endpoint (4.9% vs. 5.7%; p=0.72).Conclusions: The PIONEER trial did not meet its primary endpoint in terms of in-stent LLL at ninemonth follow-up. However, this result did not translate into any increase in restenosis rate or impairment in 12-month clinical outcomes.

Background We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens. Methods GLOBAL LEADERS was a randomised, open-label superiority trial at 130 sites in 18 countries. Patients undergoing percutaneous coronary intervention with a biolimus A9-eluting stent for stable coronary artery disease or acute coronary syndromes were randomly assigned (1:1) to 75-100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy, or standard dual antiplatelet therapy with 75-100 mg aspirin daily plus either 75 mg clopidogrel daily (for patients with stable coronary artery disease) or 90 mg ticagrelor twice daily (for patients with acute coronary syndromes) for 12 months, followed by aspirin monotherapy for 12 months. Randomisation was concealed, stratified by centre and clinical presentation (stable coronary artery disease vs acute coronary syndrome), and blocked, with randomly varied block sizes of two and four. The primary endpoint at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction as assessed by a core lab in a blinded manner. The key secondary safety endpoint was site-reported bleeding assessed according to the Bleeding Academic Research Consortium criteria (grade 3 or 5). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01813435, and is closed to new participants, with followup completed. Findings Between July 1, 2013, and Nov 9, 2015, 15 968 participants were randomly assigned, 7980 to the experimental group and 7988 to the control group. At 2 years, 304 (3.81%) participants in the experimental group had died or had a non-fatal centrally adjudicated new Q-wave myocardial infarction, compared with 349 (4.37%) participants in the control group (rate ratio 0.87 [95% CI 0. 75-1. 01]; p=0.073]). There was no evidence for a difference in treatment effects for the primary endpoint across prespecified subgroups of acute coronary syndromes and stable coronary artery disease (p=0.93). Grade 3 or 5 bleeding occurred in 163 participants in the experimental group and 169 in the control group (2.04% vs 2.12%; rate ratio 0.97 [95% CI 0. 78-1. 20]; p=0.77). Interpretation Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to 12 months of standard dual antiplatelet therapy followed by 12 months of aspirin alone in the prevention of all-cause mortality or new Q-wave myocardial infarction 2 years after percutaneous coronary intervention. Copright (C) 2018 Elsevier Ltd. All rights reserved. European Clinical Research Institute; Biosensors International; AstraZeneca; Medicines Company; Canada Research Chairs Programme

New-generation drug-eluting stents (DES) represent the current standard of care in patients undergoing percutaneous coronary intervention (PCI). Biodegradable polymer DES (BP-DES) were recently developed to overcome current limitations of newer-generation durable polymer DES (DP-DES) attributed to sustained inflammatory responses induced by permanent polymers. The Orsiro DES (Biotronik AG, Bülach, Switzerland) is a novel thin-strut cobalt-chromium sirolimus-eluting stent with biodegradable polymer that features some of the latest developments in DES technology. Areas covered: This article aims to review the currently available evidence on the clinical performance of the Orsiro BP-DES and its future perspectives. Expert commentary: The Orsiro DES is a recent newer-generation BP-DES that combines a highly deliverable thin-strut cobalt-chromium stent platform and a unique hybrid concept with passive and active coatings designed to enhance tissue biocompatibility. In preclinical and intravascular imaging studies, the Orsiro BP-DES was shown to induce low inflammation and promote very early arterial healing. Recently, large randomized non-inferiority clinical trials have shown similar short- and mid-term efficacy and safety outcomes with Orsiro BP-DES compared with currently established newer-generation DES among all-comers and high-risk subgroups. The potential clinical superiority of Orsiro BP-DES over Xience DP-DES in patients with STEMI is currently investigated in the BIOSTEMI trial (NCT02579031).

Objectives This study aimed to provide a systematic review of device-associated thrombosis (DAT) after left atrial appendage occlusion (LAAO) with the Watchman, Amplatzer Cardiac Plug, and Amulet devices. Background DAT is known as a complication of LAAO but data about its clinical impact is scarce. Methods A systematic review of studies evaluating the incidence, treatment and clinical implications of DAT from January 2008 to September 2015 was conducted. Results A total of 30 studies describing DAT events were included in the analysis. The overall incidence of DAT was 3.9% (82 DAT for 2118 implanted devices). The median time from procedure to diagnosis of DAT was 1.5 months (IQR: 0–2.9). Most cases were diagnosed with transesophageal echocardiogram (TEE). The treatment consisted of low molecular weight heparin (LMWH) in 45.5% of cases, and oral anticoagulation (OAC) or other treatment modalities in 54.5%. Complete thrombus resolution was achieved in 95.0% of cases (100% with LMWH and 89.5% with OAC). Treatment duration varied greatly with a median treatment duration of 45 days (IQR: 14–135). Clinical events related to DAT consisted of neurologic events namely two transient ischemic attacks (2.4%) and four ischemic strokes (4.9%). Conclusions DAT is an infrequent complication of percutaneous LAAO. It occurs mainly early after the procedure and is associated with a low rate of neurological complications. In the majority of cases, diagnosis is made during follow-up imaging with TEE. Anticoagulation treatment seems to be safe and highly effective. Further studies are needed to evaluate the optimal management of DAT. © 2017 Wiley Periodicals, Inc.

OBJECTIVES: Routine device surveillance after successful left atrial appendage closure is recommended to evaluate for intermediate to late complications. The aim of this study was to assess the incidence and clinical impact of these complications on cardiovascular events.METHODS: Centers participating in the Amplatzer Cardiac Plug multicenter study were requested to submit their post-procedural transesophageal echocardiograms for independent adjudication. Thirteen of 22 centers contributed all their post-procedural echocardiograms, which included 344 from 605 consecutive patients. These images were submitted to a core laboratory and reviewed by 2 independent experts for peri-device leak, device-associated thrombus, device embolization, device migration, left atrial appendage thrombus, and left atrial thrombus. Clinical events were prospectively collected by each center.RESULTS: Of the 344 transesophageal echocardiograms, 339 were deemed analyzable. Patients' mean age was 74.4 ± 7.5 years, and 67.3% were men. The mean CHADS2 score was 2.7 ± 1.3, the mean CHA2DS2-VASc score was 4.3 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.2. Amplatzer Cardiac Plug implantation was successful in all patients. Periprocedural major adverse events occurred in 2.4%. Median clinical follow-up duration was 355 days (range 179 to 622 days). Follow-up transesophageal echocardiography was performed after a median of 134 days (range 88 to 227 days). Device-associated thrombus was observed in 3.2% and peri-device leak in 12.5% (5.5% minimal, 5.8% mild, 0.6% moderate, 0.6% severe). Neither device-associated thrombus nor peri-device leak was associated with an increased risk for cardiovascular events. Independent predictors of device-associated thrombus were smoking (odds ratio: 5.79; p = 0.017) and female sex (odds ratio: 4.22; p = 0.027).CONCLUSIONS: Following successful left atrial appendage closure with the Amplatzer Cardiac Plug, the presence of peri-device leak was relatively low, and device-associated thrombus was infrequent. Neither was associated with increased risk for thromboembolism.

AIMS A transfemoral transarterial approach is considered the preferable access route for transcatheter aortic valve implantation (TAVI), followed by a transaxillary/subclavian TAVI approach. However, these approaches may not be an option in all patients. This study aimed to report the initial European experience with transfemoral transcaval TAVI. METHODS AND RESULTS Data on 50 patients treated by transcaval TAVI in five European centres were collected and analysed according to the Valve Academic Research Consortium (VARC)-2 definitions. The study population had a mean age of 78.7±8.0 years and a high surgical risk profile (median STS risk score 6.1%, interquartile range 3.0-11.2%). Transcaval access was successful in 49 out of 50 patients and device success was obtained in 94% of cases. Closure of the caval-aortic puncture site with a nitinol cardiac occluder was successful in all cases without need for emergent surgery. One patient received additional sealing of the aortic puncture site with a covered stent one day post TAVI due to a gradual haemoglobin drop of 3 g/dL. VARC-2-defined life-threatening bleeding and major vascular complications possibly related to transcaval access were 4% and 10%, respectively. There were no bleeding or vascular complications after discharge. At 30 days, the clinical efficacy endpoint was reached in 88% of patients. CONCLUSIONS Transfemoral transcaval access proved to be a feasible and safe TAVI approach for high-risk patients with severe aortic stenosis not suitable for transfemoral or transaxillary/subclavian transarterial access.

Objective: Recruitment and retention in trials may bias the results and subsequently complicate their interpretation and validity. The aim of this study is to evaluate the impact of recruitment and retention on all-cause mortality in a large all-comers trial. Methods: The recruitment rate in each investigating center of the GLOBAL LEADERS trial was assessed and the 130 centers were subdivided into low and high recruiters according to the median, with all-cause mortality then compared between the two groups. Vital status was obtained from public records in patients with incomplete follow-up. Results: The trial randomized 15,991 (7.86%) of 203,483 eligible patients with percutaneous coronary intervention during the recruitment period, of whom 15,267 (95.47%) completed follow-up, 23 (0.14%) patients withdrew consent and formally requested to be deleted from the database; 183 (1.14%) withdrew consent but only objected to future data collection; 303 (1.89%) discontinued the study; and 215 (1.34%) were lost to follow-up. Vital status was finally obtained in all but 31 patients (99.81%). Patients from low recruiters had a significantly lower all-cause mortality than high ones (2.26% vs. 3.24%; hazard ratio: 0.69; 95% confidence interval: 0.55–0.87; p = 0.002). There was a significant difference in all-cause mortality among the incomplete follow-up groups (log-rank p < 0.001) with a significantly higher mortality in the 183 patients who withdrew consent than those who completed follow-up (7.38% vs. 2.99%, p = 0.002). Conclusions: Recruitment and retention significantly impacted all-cause mortality. Search for vital status through public domains is of paramount importance in the interpretation and validity of large clinical trials. Graphic abstract: [Figure not available: see fulltext.].

Coronary bifurcation revascularization needs to take account of the diameter differential between vessels and to limit side-branch obstruction (SBO). The self-apposing properties of the Xposition S™ stent (STENTYS, France) seem interesting in this regard. The present experimental fractal bench study determined the best provisional stenting technique using Xposition S™. Three sequential strategies were compared (n = 5/group): implantation alone, side-branch inflation (SBI), and re-POT (initial proximal optimization technique (POT) + SBI + final POT). 2D- and 3D-OCT analyses and micro-CT scan were performed to quantify the main mechanical results at each step. Of the three groups, SBI and re-POT provided better final results than implantation alone in terms of residual SBO (respectively, 24.6 ± 5.6% and 24.8 ± 5.0% vs. 46.5 ± 10.3%, p

Background: The GLOBAL LEADERS (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) study randomly assigned 15,991 patients undergoing percutaneous coronary intervention to 1-month dual antiplatelet therapy (DAPT) followed by 23-month ticagrelor monotherapy or conventional 12-month DAPT followed by 12-month aspirin. Apart from Q-wave myocardial infarction (MI), all study endpoints were analyzed as investigator reported. Objectives: This was a pre-specified ancillary study assessing whether experimental therapy is noninferior, and if met, superior, to conventional treatment for the coprimary efficacy endpoint of all-cause death, nonfatal MI, nonfatal stroke, or urgent target vessel revascularization and superior in preventing BARC 3 (Bleeding Academic Research Consortium) or 5 bleeding (coprimary safety endpoint) at 2 years with a 0.025 significance level to preserve nominal 5% alpha error. Methods: An independent clinical event committee adjudicated investigator-reported and eventually unreported events of 7,585 patients from the 20 top-enrolling participating sites. Results: The 2-year coprimary efficacy endpoint occurred in 271 (7.14%) and in 319 (8.41%) patients in the experimental and conventional groups, respectively (rate ratio [RR]: 0.85; 95% confidence interval [CI]: 0.72 to 0.99), fulfilling noninferiority (p noninferiority

IntroductionThe GLOBAL LEADERS is an open-label, pragmatic and superiority randomised controlled trial designed to challenge the current treatment paradigm of dual antiplatelet therapy (DAPT) for 12 months followed by aspirin monotherapy among patients undergoing percutaneous coronary intervention. By design, all study endpoints are investigator reported (IR) and not subject to formal adjudication by an independent Clinical Event Committee (CEC), which may introduce detection, reporting or ascertainment bias.Methods and analysisWe designed the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY) to prospectively implement, in a large sample of patients enrolled within the GLOBAL LEADERS trial (7585 of 15 991, 47.5%), an independent adjudication process of reported and unreported potential endpoints, using standardised CEC procedures, in order to assess whether 23-month ticagrelor monotherapy (90 mg twice daily) after 1-month DAPT is non-inferior to a standard regimen of DAPT for 12 months followed by aspirin monotherapy for the primary efficacy endpoint of death, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularisation and superior for the primary safety endpoint of type 3 or 5 bleeding according to the Bleeding Academic Research Consortium criteria.This study will comprehensively assess the comparative safety and efficacy of the two tested antithrombotic strategies on CEC-adjudicated ischaemic and bleeding endpoints and will provide insights into the role of a standardised CEC adjudication process on the interpretation of study findings by quantifying the level of concordance between IR-reported and CEC-adjudicated events.Ethics and disseminationGLASSY has been approved by local ethics committee of all study sites and/or by the central ethics committee for the country depending on country-specific regulations. In all cases, they deemed that it was not necessary to obtain further informed consent from individual subjects.Trial registration numberNCT01813435.

Cardioembolic strokes are generally more lethal and disabling than other source of strokes. Data from PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) suggest that strokes after left atrial appendage occlusion (LAAO) with the Watchman device are less disabling than those in the warfarin group. No data assessing the severity of strokes after LAAO with the AMPLATZER Cardiac Plug (ACP) are available. The objective of the study was to evaluate the severity of cerebrovascular events after LAAO with the ACP in a population mostly characterized by an absolute or relative contraindication to oral anticoagulation. Data from the ACP multicenter registry were analyzed. Disabling strokes were defined as those with a modified Rankin score of 3 to 6 at 90 days after the event. A total of 1,047 subjects were included. The mean age and CHADS2 score were 75 ± 8 years and 2.8 ± 1.3, respectively. Procedural success was achieved in 97.3% and 4.9% of the patients presented procedural major adverse events. Clinical follow-up was complete in 98.2% of patients with a median of 13 months. There were 9 strokes (0.9%), 9 transient ischemic attacks (0.9%), and no intracranial hemorrhages (0%) at follow-up. After excluding 2 patients with pre-LAAO disability, functional assessment showed disabling events in 3 (19%) of the remaining 16 patients. The median time of presentation was 420 days (interquartile range 234 to 671) after LAAO, and 17 patients (94%) were on single-antiplatelet therapy when the event occurred. According to our results, cerebrovascular events after LAAO with the ACP system were infrequent and mostly nondisabling.

Purpose To assess the feasibility and safety of the 7 French (Fr) Glidesheath Slender for complex transradial (TR) percutaneous coronary interventions (PCI). Background The TR approach is increasingly used worldwide for coronary and peripheral vascular interventions. However, the small size of the radial artery remains an important limitation for the use of large-bore guiding catheters (>6 Fr), restricting thereby the treatment of highly complex lesions through the TR approach. The 7 Fr Glidesheath slender (Terumo, Tokyo, Japan) is a new dedicated radial sheath with a thinner wall and hydrophilic coating. It combines an inner diameter compatible with any 7 Fr guiding catheter and an outer diameter smaller than current 7 Fr sheaths. Methods Prospective multicenter registry of complex TR PCI cases using the 7 Fr Glidesheath Slender to determine the procedural success, rates of vascular complications, radial spasm, and radial artery occlusion (RAO). Results A total of 60 patients were included. Procedural success was 97% with only one access-site crossover. The use of a 7 Fr guiding catheter was indicated for the treatment of highly complex coronary lesions including distal left main (LM) disease (n = 20), complex non-LM bifurcation lesions (n = 16), chronic total occlusion (n = 15), and severely calcified vessels requiring rotational atherectomy (n = 10). There were three vascular access-site complications (4.7%) including two moderate (type II) local hematoma and one uncomplicated guiding catheter-induced brachial artery dissection. None of the patients experienced major bleeding. The occurrence of radial spasm was reported in seven patients (11%). Doppler ultrasound imaging of the radial artery at 1 month was available in 62 of 64 radial access with three cases of RAO (4.8%). Conclusions Use of the 7 Fr Glidesheath slender for complex coronary interventions is feasible and associated with a high rate of procedural success and a low rate of vascular complications. These favorable results need be confirmed in larger multicenter studies. © 2016 Wiley Periodicals, Inc.

AIMS: This document aims to describe a standardised methodology for performing left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device, and to provide useful tips and tricks for operators with different levels of experience.METHODS AND RESULTS: Physicians who are experts in LAAO and had personal clinical experience with the AMPLATZER Amulet device were asked to contribute in the preparation of this consensus document. Twenty-seven physicians (20 interventional cardiologists and 7 electrophysiologists) from 14 different countries reviewed the manuscript. A step-by-step approach, simulating a real case, was followed. Starting with patient selection and planning, related cardiac imaging is discussed, followed by vascular access - transseptal puncture optimisation. Then, angiographic calibration/sizing and the required fluoroscopy views are explained and a device sizing strategy is proposed. Device preparation and de-airing is briefly described, followed by sheath exchange, device deployment steps, evaluation of device stability and decision for final release. The way to recapture and change a device is then shown, together with some additional tips on how to deal with challenging anatomies like "chicken wing" left atrial appendage. Finally, for operators who are switching from AMPLATZER Cardiac Plug to Amulet, the main differences between the two devices with respect to implantation technique are presented.CONCLUSIONS: In conclusion, this document reflects a consensus approach by expert implanters on the steps of LAAO technique and best practices for implantation of the AMPLATZER Amulet device, along with some practical tips to minimise the complication rate.

Background The newest iteration of the durable polymer zotarolimus-eluting stents (ZES) is designed with thin swaged shape composite-wire struts (inner platinum–iridium core and outer cobalt–chromium layer). It is of interest to compare the clinical performance of this novel device with its predecessor in all-comers. Purpose The purpose of the present study is to assess 2-year clinical outcome in all-comer patients who were treated with the novel ZES versus the previous iteration ZES. Methods We did a post-hoc analysis of clinical outcome data of 2374 patients who were treated with the novel or the previous generation ZES (only nominal stent diameters that were available for both devices) in two consecutive large-scale randomised all-comer trials. A total of 1201 trial participants were treated with the novel ZES, and 1173 were treated with the previous generation ZES. The main outcome parameter target vessel failure is a composite of safety (cardiac death, target vessel myocardial infarction) and efficacy (target vessel revascularisation). Clinical outcome data were analysed with Kaplan-Meier methods and hazard ratios were computed with Cox regression analysis. An additional analysis was done in a subgroup of patients who presented with chronic coronary syndromes. Results The mean age of the study population was 63.9±10.9 years, 611 (25.7%) were female and 1669 (70.3%) presented with acute coronary syndromes. Two-year follow-up was available in 2346 (98.8%) participants. After 2 years, there was no significant difference between stent-groups in the rates of target vessel failure (7.2% vs. 8.3%, HR 0.85, 95% CI 0.64–1.14, p-logrank = 0.28; Figure 1) or its individual components. Peri-procedural myocardial infarction occurred less often in patients treated with the novel ZES (0.7% vs. 2.1%, p-logrank Conclusions The novel ZES showed similar 2-year clinical outcomes as compared to its predecessor. Furthermore, there was a positive safety signal regarding the incidence of target vessel myocardial infarction and a particularly low stent thrombosis rates with the novel ZES. Figure 1. Target vessel failure at 2 years Funding Acknowledgement Type of funding source: Other. Main funding source(s): Thoraxcentrum Twente has received institutional research grants provided by Abbott Vascular, Biotronik, Boston Scientific and Medtronic. The present analysis received no funding.

BackgroundOptimal preprocedural planning is essential to ensure successful device closure of the left atrial appendage (LAA).DesignThe PREDICT-LAA study is a prospective, international, multicentre, randomised controlled trial (ClinicalTrials.gov NCT04180605). Two hundred patients eligible for LAA closure with an Amplatzer Amulet device (Abbott, USA) will be enrolled in the study. Patients will be allocated to a computational simulation arm (experimental) or standard treatment arm (control) using a 1:1 randomisation. For patients randomised to the computational simulation arm, preprocedural planning will be based on the analysis of cardiac computed tomography (CCT)-based patient-specific computational simulations (FEops HEARTguide, Ghent, Belgium) in order to predict optimal device size and position. For patients in the control arm, preprocedural planning will be based on local practice including CCT analysis. The LAA closure procedure and postprocedural antithrombotic therapy will follow local practice in both arms. The primary endpoint of the study is incomplete LAA closure and device-related thrombus as assessed at 3 months postprocedural CCT. Secondary endpoints encompass procedural efficiency (number of devices used, number of repositioning, procedural time, radiation exposure, contrast dye), procedure-related complications within 7 days postprocedure and a composite of all-cause death and thromboembolic events at 12 months.ConclusionThe objective of the PREDICT-LAA study is to test the hypothesis that a preprocedural planning for LAA closure with the Amplatzer Amulet device based on patient-specific computational simulations can result in a more efficient procedure, optimised procedural outcomes and better clinical outcomes as compared with a standard preprocedural planning.Trial registration numberClinicalTrials.gov Registry (NCT04180605).

Background Percutaneous paravalvular leak closure (PVLc) has emerged as an alternative to surgery. It remains a technically challenging procedure. We aim to compare outcomes after mitral and aortic PVLc. Methods We analyzed data from PVLc procedures performed over the 2 first years of inclusion in the FFPP (Fermeture de Fuite Periprothetique) study, a prospective observational industry-independent cohort study which started in January 2017. Results We analyzed 147 PVLc (99 mitral–48 aortic), performed in 127 patients (1 procedure in 109 patients, 2 in 16 and 3 in 2) included in 22 centers among 3 countries (France, Poland and Belgium). Age (69 ± 10 versus 69 ± 11 yo), left ventricular ejection fraction (56 versus 51%), Euroscore2 (9 versus 7.6) and rate of mechanical valve (56.7% versus 41.7%, P = 0.1) were not significantly different among mitral and aortic groups. All patients had heart failure and/or hemolytic anemia. Hemolysis was more common in mitral PVL (62 versus 43%, P = 0.04). A mean of 1.4 (min 1, max 3) and 1.8 (min 1 max 5) devices were respectively required for technically successful aortic and mitral PVLc. No complication was reported in procedures with failure of device implantation. Aortic PVLc were faster than mitral PVLc (1h18 versus 2h20), with a trend towards a higher rate of technical success (96% versus 87%, P = 0.1) and fewer rate of major adverse events (worsening hemolysis, stroke, life threatening events and deaths; 2% versus 14%, P = 0.02). At 1 month follow-up, events were reported in 2% of patients (blood transfusion for hemolysis) versus 26.2% (deaths 3.3%; hemolysis 14.8%; heart failure 3.3%; heart failure and hemolysis 4.9%) after successful aortic and mitral PVLc respectively, P = 0.6. Conclusion Mitral PVLc is a more complex procedure than aortic PVLc, with a lower success rate and a higher risk of peri-procedural and one-month severe adverse events. Longer follow-up data are expected and will be available from this on-going study.

Summary Background During the past decade, many patients had zotarolimus-eluting stents implanted, which had circular shape cobalt–chromium struts with limited radiographic visibility. The Resolute Onyx stent was developed to improve visibility while reducing strut thickness, which was achieved by using a novel composite wire with a dense platinum–iridium core and an outer cobalt–chromium layer. We did the first randomised clinical trial to assess the safety and efficacy of this often-used stent compared with the Orsiro stent, which consists of ultrathin cobalt–chromium struts. Methods We did an investigator-initiated, assessor-blinded and patient-blinded, randomised non-inferiority trial in an allcomers population at seven independently monitored centres in Belgium, Israel, and the Netherlands. Eligible participants were aged 18 years or older and required percutaneous coronary intervention with drug-eluting stents. After guide wire passage with or without predilation, members of the catheterisation laboratory team used web-based computer-generated allocation sequences to randomly assign patients (1:1) to either the Resolute Onyx or the Orsiro stent. Randomisation was stratified by sex and diabetes status. Patients and assessors were masked to allocated stents, but treating clinicians were not. The primary endpoint was target vessel failure at 1 year, a composite of cardiac death, target-vessel-related myocardial infarction, and target vessel revascularisation, and was assessed by intention to treat (non-inferiority margin 2·5%) on the basis of outcomes adjudicated by an independent event committee. This trial is registered with ClinicalTrials.gov , number NCT02508714 . Findings Between Oct 7, 2015, and Dec 23, 2016, 2516 patients were enrolled, 2488 of whom were included in the intention-to-treat analysis (28 withdrawals or screening failures). 1243 participants were assigned to the Resolute Onyx group, and 1245 to the Orsiro group. Overall, 1765 (70·9%) participants presented with acute coronary syndromes and 1275 (51·2%) had myocardial infarctions. 1-year follow-up was available for 2478 (99·6%) patients. The primary endpoint was met by 55 (4·5%) patients in the Resolute Onyx group and 58 (4·7%) in the Orsiro group. Non-inferiority of Resolute Onyx to Orsiro was thus established (absolute risk difference −0·2% [95% CI −1·9 to 1·4]; upper limit of the one-sided 95% CI 1·1%; p non-inferiority =0·0005). Definite or probable stent thrombosis occurred in one (0·1%) participant in the Resolute Onyx group and nine (0·7%) in the Orsiro group (hazard ratio 0·11 [95% CI 0·01–0·87]; p=0·0112). Interpretation The Resolute Onyx stent was non-inferior to Orsiro for a combined safety and efficacy endpoint at 1-year follow-up in allcomers. The low event rate in both groups suggests that both stents are safe, and the very low rate of stent thrombosis in the Resolute Onyx group warrants further clinical investigation. Funding Biotronik and Medtronic.

AIMS: Quantitative Flow Ratio (QFR) based on 3-dimensional quantitative coronary angiography (3D-QCA) is a novel method to assess the physiological functionality after treatment with stents. The current study aimed to evaluate the difference in physiological functionality 9 months after implantation of a bioresorbable polymer-based sirolimus-eluting stent with an electrografting base layer (BuMA Supreme: B-SES) versus a durable polymer-based zotarolimus-eluting stent (Resolute: R-ZES).METHODS AND RESULTS: The current post-hoc analysis was performed in the PIONEER randomized trial (1:1 randomization to B-SES [83 patients/95 lesions] and R-ZES [87 patients/101 lesions]). QFR was measured in stented vessels in both arms at pre-procedural, post-procedural and 9-month angiography without pharmacologically induced hyperemia (contrast QFR). At 9 months, both the values of QFR distal to the stent (B-SES: 0.89 +/- 0.10 vs. R-ZES: 0.89 +/- 0.11, p=0.97) and the numbers of the vessels with QFR =0.8 were not significantly different between the two groups (11.0% vs. 12.8%, p=0.72), while the in-stent binary restenosis rate was also comparable (3.7% versus 3.5%, P=1.00). QFR gradient across the device (?QFR) at 9 months was also similar between both groups (B-SES: 0.03 +/- 0.04 vs. R-ZES: 0.03 +/- 0.07, p=0.95).CONCLUSIONS: Quantitative flow assessment 9 months after stenting did not differ between B-SES and R-ZES, despite of a significant difference in in-stent late lumen loss.

Aim The aim was to compare in a noninferiority trial the efficacy and safety of 2 contemporary drug-eluting stents (DESs): a novel, durable polymer-coated stent versus an established bioabsorbable polymer-coated stent. Methods and results The BIONYX trial (ClinicalTrials.gov-no.NCT02508714) is an investigator-initiated, prospective, randomized, patient- and assessor-blinded, international, multicenter study in all-comer patients with all types of clinical syndromes and lesions who require percutaneous coronary interventions with DES. Patients at 7 study sites in the Netherlands, Belgium, and Israel were randomly assigned (1:1, stratified for gender and diabetes mellitus) to treatment with the novel, zotarolimus-eluting, durable polymer-coated Resolute Onyx stent that has a radiopaque, thin-strut, CoreWire stent platform versus the sirolimus-eluting, bioresorbable polymer-coated Orsiro stent (reference device) that has a very thin-strut, cobalt-chromium stent backbone. The primary end point is the 1-year incidence of the composite clinical end point target vessel failure consisting of cardiac death, target vessel-related myocardial infarction, or clinically indicated target vessel revascularization. A power calculation, assuming a target vessel failure rate of 6.0% (noninferiority margin 2.5%), revealed that 2,470 study patients would give the study 80% power (a level 5%), allowing for up to 3% loss to follow-up. The first patient was enrolled on October 7, 2015; on December 23, 2016, the last patient entered the study. Conclusions BIONYX is a large-scale, prospective, randomized, international, multicenter trial comparing a novel DES with durable coating versus a reference DES with biodegradable coating in all-corners. The study is the first randomized assessment of the Resolute Onyx stent, which is an often-used DES outside the United States. Biotronik; Medtronic

Background: During transradial (TR) access, it remains unclear whether differences in baseline patients characteristics and hemostasis care impact the rate of radial artery occlusion (RAO). We sought to compare the rate of RAO after TR access with the 6 French(Fr) Glidesheath Slender (GSS6Fr, Terumo, Japan) or a standard 5 Fr sheath in Japanese and non-Japanese patients. Methods and Results: The Radial Artery Patency and Bleeding, Efficacy, Adverse evenT (RAP and BEAT) trial randomized 1,836 patients undergoing TR coronary angiography and/or interventions to receive the GSS6Fr or the standard 5 Fr Glidesheath (GS5Fr, Terumo, Japan). Out of this study population, 1,087 were Japanese patients and 751 non-Japanese patients. The overall incidence of RAO was significantly higher in Japanese patients (3.6% vs. 1.2%, P = 0.002). Use of GSS6Fr was associated with higher rates of RAO than GS5Fr in Japanese patients (5% vs. 2.2%, P = 0.02) and with similar RAO rates in non-Japanese patients (1.3 vs. 1.1%, P = 1). The mean hemostasis time was significantly longer in Japanese patients (378 ± 253 vs. 159 ± 136 min, P < 0.001) and more Japanese patients had a hemostasis time of more than 6 hr (16.2% vs. 4.9%, P < 0.0001). Longer hemostasis time was an independent predictor of RAO (OR per additional hour 1.070, 95% CI 1.008–1.136, P = 0.03). Conclusions: Use of GSS6Fr was associated with a higher rate of RAO than a standard 5 Fr sheath in Japanese patients but not in non-Japanese patients. Whether improvement in post-procedural care and reduced hemostasis time could impact the incidence of RAO in Japanese patients should be further assessed.

Aims This study aimed to assess the safety and efficacy at midterm follow-up of left atrial appendage occlusion (LAAO) using different devices, in real life in Belgium. Methods and results Between June 2009 and November 2016, 457 consecutive patients (63% male, 75±12 yrs, CHA2DS2-VASc 4±0.6, HAS-BLED 3.5±0.7) undergoing LAAO were included. Technical success was 97.1%. There were 19 periprocedural major adverse events (4.1%) including three deaths (0.6%), nine tamponades (1.9%), four major bleedings (0.8%) and two device embolisations (0.4%). Among patients successfully implanted having a complete follow-up (672 patient-years, median follow-up 370 days), the actual annual stroke rate was 1.2%, lower than the expected stroke risk of 4% (70% reduction). The observed bleeding rate was 2%, while the calculated risk was 3.7% (46% reduction). Kaplan-Meier analysis showed a similar overall survival (93±2% and 87±3% versus 91±3% and 87±4%; p=0.35) and event-free survival (92±2% and 84±3% versus 88±3% and 80±5%; p=0.17) at one and two years, for the ACP/Amulet versus the WATCHMAN groups of patients, respectively. Conclusions The data from the Belgian left atrial appendage occlusion registry suggest that the procedure is effective and relatively safe in a real-world setting, using either the WATCHMAN or the ACP/Amulet device.

Aims: A new coronary bifurcation provisional stenting technique without kissing balloon, rePOT, associating the proximal optimisation technique (POT), side branch inflation and final POT, showed excellent mechanical results in a bench test. The present study sought to use optical coherence tomography (OCT) to quantify the mechanical results of rePOT in vivo in a large patient sample with complex coronary bifurcations. Methods and results: A total of 106 patients with coronary bifurcations were included in a multicentre prospective registry (left main, 40.6%; true Medina bifurcation, 39.6%). Three OCT runs were performed, at baseline, just after stent implantation and after the complete rePOT sequence, quantifying global malapposition, side branch obstruction (SBO), and various geometric arterial criteria. RePOT was completed systematically. RePOT significantly reduced global strut malapposition from 18.9 +/- 13.4% just after stent implantation to 3.2 +/- 3.9% (p\textless0.05), residual SBO from 44.3 +/- 12.9% to 17.0 +/- 14.3% (p\textless0.05), and ellipticity index from 1.19 +/- 0.11 to 1.13 +/- 0.12 (p\textless0.05). Exhaustive six-month follow-up found only one mother-vessel target lesion revascularisation. Conclusions: This clinical study of a large sample of complex coronary bifurcations with OCT analysis showed the benefit of the rePOT sequence in provisional stenting, replicating in vivo the excellent in vitro geometric results previously reported, and confirming ease of implementation and medium-term safety.

Case 1. A 82-year-old male underwent mitral valve repair using MitraClip for secondary severe mitral regurgitation (67th consecutive case, centre 1). Just before release of the second clip, the pat...

We present a case of a 69-year-old woman with a history of ascendant aortic (Ao) dissection who underwent emergency repair with an aortic graft combined with bioprosthetic valve implantation in 201...

Objectives We sought to provide a systematic review of reported cases of LAA closure device embolization by focusing on the two most commonly implanted devices: the Watchman (WM) device and the Amplatzer Cardiac Plug (ACP). Methods A comprehensive search of the Pubmed database was conducted until October 1, 2014. Studies were included if they described at least 1 case of embolization of the WM and/or the ACP. Results A total of 20 studies reporting 31 cases of device embolization were identified, including 13 cases with WM and 18 cases. The timing of embolization was described in 29 cases and was categorized as acute in 20 cases (65%) and late in 9 cases (30%). The anatomical location of embolized devices was reported in 21 cases: into the aorta in 9 cases, into the left ventricle (LV) in 9 cases and into the left atrial cavity in 3 cases. As compared to embolization into the aorta or the left atrial cavity, device embolization into the LV was associated with a higher rate of surgical retrieval (8/9 vs 2/12; 88% vs 17%, P = 0.0019). Major adverse events related to device embolization occurred in three patients (9.6%). Conclusions LAA closure device embolization occurs mainly in the periprocedural period but late embolizations are not uncommon. Although embolization into the aorta or the left atrium can be successfully managed by percutaneous techniques in most cases, device embolization into the LV is associated with a higher rate of surgical retrieval, increasing thereby procedure-related morbidity. © 2015 Wiley Periodicals, Inc.