Journal: EuroIntervention

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Abstract

Intravascular Imaging and Histological Correlates of Medial and Intimal Calcification in Peripheral Artery Disease.

Jinnouchi H, Sato Y, Bhoite RR, Kuntz SH, ... Virmani R, Finn AV
Background
In peripheral artery disease, two different types of calcifications are frequently observed, i.e., medial and intimal calcification.
Aims
The aim of this study is to determine the ability of intra-vessel ultrasound imaging (IVUS) and optical frequency domain imaging (OFDI) to detect medial and intimal calcification in human peripheral arteries.
Methods
We performed ex vivo intravascular imaging of cadaveric human peripheral arteries with calcifications. IVUS and OFDI images were co-registered with histology. A total 12 legs from 9 patients were examined, and 438 cross-sectional images were co-registered with histology.
Results
OFDI could detected 183 of 231 intimal calcification by histology, whereas IVUS could detect 194 [OFDI; sensitivity, 79%, specificity, 86%, area under the curve (AUC), 0.83; IVUS; sensitivity, 84%, specificity, 85%, AUC, 0.85]. Of 245 medial calcifications by histology, 160 and 164 were detected by OFDI and IVUS, respectively (OFDI; sensitivity, 65%, specificity, 85%, AUC, 0.75; IVUS; sensitivity, 67%, specificity, 80%, AUC, 0.74). Medial calcification with overlying intimal calcification (overlapped calcification) and unclear border between intima and media were the main reasons for misdiagnosis. Without those 89 overlapped calcifications, sensitivity in both OFDI and IVUS was improved (OFDI; sensitivity, 81%, specificity, 85%, AUC, 0.83; IVUS; sensitivity, 88%, specificity, 80%, AUC, 0.84).
Conclusions
There are limitation in detecting medial calcification in overlapped intimal calcification and with unclear border between intima and media by both IVUS and OFDI. It is important to distinguish medial calcification from intimal calcification before proceeding with endovascular therapy since different approaches should be required.



EuroIntervention: 25 Apr 2021; epub ahead of print
Jinnouchi H, Sato Y, Bhoite RR, Kuntz SH, ... Virmani R, Finn AV
EuroIntervention: 25 Apr 2021; epub ahead of print | PMID: 33896763
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Abstract

BioMatrix versus Orsiro biodegradable polymer stents in all-comer patients with coronary artery disease: the multicentre, randomised BIODEGRADE trial.

Yoon CH, Choi YJ, Park JJ, Kang SH, ... Kim SH, Chae IH
Aims
The aim of this trial was to compare the safety and efficacy of a thin-strut biodegradable polymer sirolimus-eluting cobalt-chromium stent (Orsiro) to a thick-strut biodegradable polymer biolimus-eluting stent (BioMatrix).
Methods and results
This randomised, open-label, non-inferiority trial was conducted among patients undergoing percutaneous coronary intervention. The primary endpoint was target lesion failure (TLF). Between July 2014 and September 2017, we randomly assigned 2,341 patients to BioMatrix stents (n=1,166) or Orsiro stents (n=1,175). We analysed 2,327 patients who completed 18-month follow-up. The mean patient age was 63.5 years, and 1,565 (67.3%) patients presented with acute coronary syndrome. At 18 months, 34 (2.9%) patients with BioMatrix stents and 24 (2.1%) with Orsiro stents experienced TLF (hazard ratio [HR] 0.70, upper limit of one-sided 95% confidence interval: 1.18, p for non-inferiority <0.0001). No significant differences were noted in rates of cardiac death (16 [1.4%] vs 12 [1.0%], p=0.558), target lesion-related myocardial infarction (0 [0%] vs 3 [0.3%], p=0.250), target lesion revascularisation (18 [1.6%] vs 10 [0.9%], p=0.124), or stent thrombosis (0 [0%] vs 2 [0.2%], p=0.50).
Conclusions
In patients with a high prevalence of acute coronary syndrome, Orsiro stents were not inferior to BioMatrix stents. Both showed good clinical outcomes. Visual summary. Comparison of the BioMatrix and Orsiro stents: summary of 18-month outcomes. Aetiopathology of debris captured by cerebral embolic protection filters during TAVI, including risk factors for greater amounts or larger particles of debris.



EuroIntervention: 19 Apr 2021; 16:1404-1412
Yoon CH, Choi YJ, Park JJ, Kang SH, ... Kim SH, Chae IH
EuroIntervention: 19 Apr 2021; 16:1404-1412 | PMID: 32958459
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Abstract

Clinical outcomes with unselected use of an ultrathin-strut sirolimus-eluting stent: a report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).

Buccheri S, Sarno G, Erlinge D, Renlund H, ... Böhm F, James SK
Aims
The aim of this study was to assess the real-world clinical performance of a sirolimus-eluting ultrathin-strut drug-eluting stent (DES) (Orsiro) in a large nationwide cohort of patients undergoing percutaneous coronary intervention (PCI).
Methods and results
From the Swedish Coronary Angiography and Angioplasty Registry, the two-year outcomes of 4,561 patients implanted with Orsiro (Orsiro group) and 69,570 receiving other newer-generation DES (n-DES group) were analysed. The rate of definite stent thrombosis was low in both groups (0.67% and 0.83% for Orsiro and n-DES, respectively; adjusted hazard ratio [HR] 0.90, 95% confidence interval [CI]: 0.55-1.46, p-value 0.66). Restenosis was also infrequent (1.5% vs 2.0% with Orsiro and n-DES, adjusted HR 0.81, 95% CI: 0.63-1.03, p-value=0.09). The risk of target lesion revascularisation by PCI was lower in the Orsiro group (1.6% vs 2.3%, adjusted HR 0.75, 95% CI: 0.60-0.94, p-value=0.013). All-cause mortality and myocardial infarction did not show a statistically significant difference between the two groups (mortality of 7.5% in both groups, adjusted HR 0.99, 95% CI: 0.72-1.35, p-value=0.94; 6.0% vs 5.2% for myocardial infarction, adjusted HR 1.19, 95% CI: 1.00-1.43, p-value=0.06).
Conclusions
In a nationwide scenario, the use of a sirolimus-eluting ultrathin-strut DES portended favourable clinical outcomes. Visual summary. Clinical outcomes with unselected use of an ultrathin-strut sirolimus-eluting stent.



EuroIntervention: 19 Apr 2021; 16:1413-1421
Buccheri S, Sarno G, Erlinge D, Renlund H, ... Böhm F, James SK
EuroIntervention: 19 Apr 2021; 16:1413-1421 | PMID: 33016880
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Abstract

Clinical impact of intervention strategies after failed transcatheter mitral valve repair.

Alessandrini H, Dreher A, Harr C, Wohlmuth P, ... Schmoeckel M, Geidel S
Aims
Failure of transcatheter mitral valve repair (fTMVR) therapy has a decisive prognostic influence, and complex retreatment is of higher risk. The aim of this analysis was to evaluate the survival outcome following percutaneous procedures and surgery after unsuccessful TMVR interventions for different aetiologies.
Methods and results
Of 824 consecutive patients who had been treated with the MitraClip device at our institution, between September 2009 and May 2019, 63 (7.6%) symptomatic patients with therapy failure and persistent or recurrent mitral regurgitation (MR) underwent reinterventions. An outcome analysis for primary (PMR) and secondary mitral regurgitation (SMR) and subsequent percutaneous versus surgical treatment was carried out. MitraClip reinterventions were performed in 36 patients (57.1%; n=26 SMR, n=10 PMR), while 27 (42.9%; n=13 SMR, n=14 PMR) underwent open heart surgery. Surgical patients with PMR showed lower mortality than patients with SMR (p<0.0001) and ReClip patients with PMR (p=0.073). Atrial fibrillation (HR 2.915, 95% CI: [1.311, 6.480]), prior open heart surgery (2.820 [1.215, 6.544]) and chronic obstructive pulmonary disease (2.506 [1.099, 5.714]) increased the risk of death. The level of post-interventional MR had no relevant impact on survival.
Conclusions
We conclude that, after SMR and failed TMVR, reclipping is an appropriate treatment option for symptomatic patients. For PMR patients, surgery must be favoured over a reclipping procedure. However, patients with atrial fibrillation, prior open heart surgery and chronic obstructive pulmonary disease are at risk of reduced survival after reinterventions.



EuroIntervention: 19 Apr 2021; 16:1447-1454
Alessandrini H, Dreher A, Harr C, Wohlmuth P, ... Schmoeckel M, Geidel S
EuroIntervention: 19 Apr 2021; 16:1447-1454 | PMID: 33074154
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Abstract

In-hospital outcomes of COVID-19 ST-elevation myocardial infarction patients.

Rodriguez-Leor O, Cid Alvarez AB, Pérez de Prado A, Rossello X, ... Romaguera R, Moreno R
Aims
The aim of this study was to assess clinical and prognosis differences in patients with COVID-19 and STEMI.
Methods and results
Using a nationwide registry of consecutive patients managed within 42 specific STEMI care networks, we compared patient and procedure characteristics and in-hospital outcomes in two different cohorts, according to whether or not they had COVID-19. Among 1,010 consecutive STEMI patients, 91 were identified as having COVID-19 (9.0%). With the exception of smoking status (more frequent in non-COVID-19 patients) and previous coronary artery disease (more frequent in COVID-19 patients), clinical characteristics were similar between the groups, but COVID-19 patients had more heart failure on arrival (31.9% vs 18.4%, p=0.002). Mechanical thrombectomy (44% vs 33.5%, p=0.046) and GP IIb/IIIa inhibitor administration (20.9% vs 11.2%, p=0.007) were more frequent in COVID-19 patients, who had an increased in-hospital mortality (23.1% vs 5.7%, p<0.0001), that remained consistent after adjustment for age, sex, Killip class and ischaemic time (OR 4.85, 95% CI: 2.04-11.51; p<0.001). COVID-19 patients had an increase of stent thrombosis (3.3% vs 0.8%, p=0.020) and cardiogenic shock development after PCI (9.9% vs 3.8%, p=0.007).
Conclusions
Our study revealed a significant increase in in-hospital mortality, stent thrombosis and cardiogenic shock development after PCI in patients with STEMI and COVID-19 in comparison with contemporaneous non-COVID-19 STEMI patients. Visual summary. In-hospital outcomes of COVID-19 ST-elevation myocardial infarction patients.



EuroIntervention: 19 Apr 2021; 16:1426-1433
Rodriguez-Leor O, Cid Alvarez AB, Pérez de Prado A, Rossello X, ... Romaguera R, Moreno R
EuroIntervention: 19 Apr 2021; 16:1426-1433 | PMID: 33164893
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Abstract

Predictors and clinical impact of thrombosis after transcatheter mitral valve implantation using balloon-expandable bioprostheses.

Kikoïne J, Urena M, Chong Nguyen C, Fischer Q, ... Iung B, Himbert D
Aims
The aim of this study was to report the predictors and clinical impact of transcatheter heart valve (THV) thrombosis in patients undergoing transcatheter mitral valve implantation (TMVI).
Methods and results
We included 130 patients who consecutively underwent TMVI. Transoesophageal echocardiography (TOE) and/or computed tomography (CT) were performed in 91.7% of patients at discharge, in 73.3% at three months and in 72% beyond three months. THV thrombosis was defined as the presence of at least one thickened leaflet with restricted motion confirmed by TOE or contrast CT and classified as immediate, early, or late according to the timing of diagnosis. THV thrombosis was observed in 16 (12.3%) patients: immediate in 43.7%, early in 37.5% and late in 18.8%. Most of these thromboses were subclinical (93.7%) and non-obstructive (87.5%). No thromboembolic event occurred. After optimisation of antithrombotic treatment, THV thromboses resolved in all but one patient. Predictors were shock for immediate (p<0.001), male sex for early (p=0.045) and absence of anticoagulation for both early (p=0.018) and late (p=0.023) THV thromboses.
Conclusions
THV thrombosis is frequent after TMVI, occurs mainly within the first three months, is mostly subclinical and resolves after optimisation of antithrombotic treatment. An anticoagulation therapy for at least three months after the procedure is mandatory.



EuroIntervention: 19 Apr 2021; 16:1455-1462
Kikoïne J, Urena M, Chong Nguyen C, Fischer Q, ... Iung B, Himbert D
EuroIntervention: 19 Apr 2021; 16:1455-1462 | PMID: 33226001
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Abstract

Lipid-lowering therapy and percutaneous coronary interventions.

Koskinas KC, Mach F, Räber L
Although technological and procedural advances have resulted in substantial improvements in clinical outcomes following percutaneous coronary interventions (PCI), recurrent coronary events may occur despite achieving optimal procedural results. Beyond myocardial revascularisation failure related to anatomical or stent-related factors, adverse cardiovascular events post PCI often arise from non-culprit lesions not treated during index interventions. While stenting treats a focal manifestation of a systemic, progressive disease, the residual risk following an acute coronary syndrome (ACS) or elective PCI is largely related to the systemic pro-atherogenic effects of suboptimally controlled cardiovascular risk factors. Lowering atherogenic lipid levels, in particular low-density lipoprotein cholesterol (LDL-C), can halt the progression of coronary atherosclerosis and improve cardiovascular outcomes to an extent that is proportional to the magnitude of LDL-C reduction. Early (in-hospital) initiation of intensive statin therapy leads to a very early clinical benefit following ACS, and prolonged adherence to optimised lipid-lowering treatment effectively reduces longer-term cardiovascular events following PCI. Therefore, achieving guideline-recommended treatment goals for LDL-C with statins and, if indicated, with the addition of non-statin lipid-lowering drugs should become a priority for all physicians involved in the treatment of patients with coronary heart disease, including comprehensive strategies initiated during the in-hospital care of patients undergoing coronary interventions. This review article summarises current evidence on the role of LDL-C in the development and progression of coronary atherosclerosis, discusses the clinical benefits of intensive lipid-lowering treatments, and presents current guideline recommendations, with emphasis on patients undergoing PCI.



EuroIntervention: 19 Apr 2021; 16:1389-1403
Koskinas KC, Mach F, Räber L
EuroIntervention: 19 Apr 2021; 16:1389-1403 | PMID: 33875408
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Abstract

A Deep-Learning Algorithm for Detecting Acute Myocardial Infarction.

Liu WC, Lin CS, Tsai CS, Tsao TP, ... Lee CC, Lin C
Background
Delayed or misdiagnosis of acute myocardial infarction (AMI) is not unusual in the daily practice. Since 12- lead electrocardiogram (ECG) is crucial for the detection of AMI, the systematic algorithm to strengthen ECG interpretation may have important implications for improving diagnosis.
Aims
We aimed to develop a deep learning model (DLM) as a diagnostic support tool based on a 12-lead electrocardiogram.
Methods
This retrospective cohort study included 1,051/697 ECGs from 737/287 coronary angiogram (CAG)-validated STEMI/NSTEMI patients and 140,336 ECGs from 76,775 not-AMI patients at the emergency department. The DLM was trained and validated by 80% and 20% of these ECGs. A human-machine competition was conducted. The area under the receiver operating characteristic curve (AUC), sensitivity, and specificity were used to evaluate the performance of the DLM.
Results
The AUC of the DLM for STEMI detection was 0.976 in the human-machine competition, which was significantly better than that of the best physicians. Furthermore, the DLM independently demonstrated sufficient diagnostic capacity for STEMI detection (AUC=0.997; sensitivity, 98.4%; specificity, 96.9%). Regarding NSTEMI detection, the AUC of the combined DLM and conventional cardiac troponin I (cTnI) increased to 0.978, which was better than that of either the DLM (0.877) or cTnI (0.950).
Conclusions
The DLM may serve as a timely, objective and precise diagnostic decision support tool to assist emergency medical system-based networks and frontline physicians in detecting AMI and subsequently initiating reperfusion therapy.



EuroIntervention: 12 Apr 2021; epub ahead of print
Liu WC, Lin CS, Tsai CS, Tsao TP, ... Lee CC, Lin C
EuroIntervention: 12 Apr 2021; epub ahead of print | PMID: 33840640
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Abstract

Mortality after Bleeding versus Myocardial Infarction in Coronary Artery Disease: A Systematic Review and Meta-Analysis.

Piccolo R, Oliva A, Avvedimento M, Franzone A, ... Esposito G, Jüni P
Background
Bleeding is the principal safety concern of antithrombotic therapy and occurs frequently among patients with coronary artery disease (CAD).
Aims
We aim to evaluate the prognostic impact of bleeding on mortality compared with that of myocardial infarction (MI) in patients with CAD.
Methods
We searched Medline and Embase for studies that included patients with CAD and that reported both, the association between the occurrence of bleeding and mortality, and between the occurrence of MI and mortality within the same population. Adjusted hazard ratios (HRs) for mortality associated with bleeding and MI were extracted and ratio of hazard ratios (rHRs) were pooled by using inverse variance weighted random effects meta-analyses. Early events included periprocedural or within 30-day events after revascularization or acute coronary syndrome (ACS). Late events included spontaneous or beyond 30-day events after revascularization or ACS.
Results
141,059 patients were included across 16 studies and 128,660 (91%) underwent percutaneous coronary intervention. Major bleeding, increased the risk of mortality to the same extent of MI (rHRbleedingvs.MI 1.10, 95%CI, 0.71-1.71, P=0.668). Early bleeding was associated with a higher risk of mortality than early MI (rHRbleedingvs.MI 1.46, 95%CI, 1.13-1.89, P=0.004), although this finding was not present when only randomized trials were included. Late bleeding was prognostically comparable to late MI (rHRbleedingvs.MI 1.14, 95%CI, 0.87-1.49, P=0.358).
Conclusions
Compared with MI, major and late bleeding is associated with a similar increase in mortality, whereas early bleeding might have a stronger association with mortality.



EuroIntervention: 12 Apr 2021; epub ahead of print
Piccolo R, Oliva A, Avvedimento M, Franzone A, ... Esposito G, Jüni P
EuroIntervention: 12 Apr 2021; epub ahead of print | PMID: 33840639
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Abstract

Impact of clinical and haemodynamic factors on coronary flow reserve and invasive coronary flow capacity in non-obstructed coronary arteries: a patient-level pooled analysis of the DEBATE and ILIAS studies.

Stegehuis VE, Wijntjens GWM, Bax M, Meuwissen M, ... Piek JJ, van de Hoef TP
Aims
Coronary flow reserve (CFR) is a physiological index for the assessment of myocardial flow impairment due to focal or microcirculatory coronary artery disease (CAD). Coronary flow capacity (CFC) is another flow-based concept in diagnosing ischaemic heart disease, based on hyperaemic average peak velocity (hAPV) and CFR. We evaluated clinical and haemodynamic factors which potentially influence CFR and CFC in non-obstructed coronary arteries.
Methods and results
Intracoronary Doppler flow velocity measurements to obtain CFR and CFC were performed after inducing hyperaemia in 390 non-obstructed vessels of patients who were scheduled for elective percutaneous coronary intervention (PCI) of another vessel. Akaike\'s information criterion (AIC) revealed age, female gender, history of myocardial infarction, hypercholesterolaemia, diastolic blood pressure, oral nitrates and rate pressure product as independent predictors of CFR and CFC. After regression analysis, age and female gender were associated with lower CFR and age was associated with worse CFC in angiographically non-obstructed vessels.
Conclusions
Age and female gender are associated with lower CFR, and age with worse CFC in an angiographically non-obstructed coronary artery. CFC seems to be less sensitive to variations in clinical and haemodynamic parameters than CFR and is therefore a promising tool in contemporary clinical decision making in the cardiac catheterisation laboratory.



EuroIntervention: 01 Apr 2021; 16:e1503-e1510
Stegehuis VE, Wijntjens GWM, Bax M, Meuwissen M, ... Piek JJ, van de Hoef TP
EuroIntervention: 01 Apr 2021; 16:e1503-e1510 | PMID: 31951205
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Abstract

Biodegradable polymer-coated versus durable polymer-coated sirolimus-eluting stents: the final 5-year outcomes of the I-LOVE-IT 2 trial.

Xu K, Xu B, Guan C, Jing Q, ... Yang Y, Han Y
Aims
This analysis presents the final five-year results of the I-LOVE-IT 2 trial, a non-inferiority study comparing a biodegradable polymer (BP) sirolimus-eluting stent (SES) with a durable polymer (DP) SES in patients with coronary artery disease.
Methods and results
Overall, 2,737 Chinese patients eligible for coronary stenting were treated with BP-SES or DP-SES in a 2:1 ratio. Patients who were randomised to the BP-SES group were additionally re-randomised to receive either six-month or 12-month dual antiplatelet therapy (DAPT) in a 1:1 ratio. The primary endpoint was 12-month target lesion failure (TLF: cardiac death, target vessel myocardial infarction (MI), or clinically indicated target lesion revascularisation). At five years, the overall follow-up rate was 90.8%, and the cumulative incidence of TLF as the primary endpoint was similar between BP-SES and DP-SES (hazard ratio [HR] 1.01, 95% confidence interval [CI]: 0.79 to 1.28), as was that for the patient-oriented composite endpoint (PoCE: all-cause death, all MI and any revascularisation) (HR 1.03, 95% CI: 0.86 to 1.23), or definite/probable stent thrombosis (ST) (HR 0.91, 95% CI: 0.70 to 1.77). Cumulative events were also similar between the six-month DAPT and 12-month DAPT groups after BP-SES implantation.
Conclusions
I-LOVE-IT 2 showed that the five-year safety and efficacy of BP-SES and DP-SES were similar, as were those between six months and 12 months of DAPT after BP-SES implantation.



EuroIntervention: 01 Apr 2021; 16:e1518-e1526
Xu K, Xu B, Guan C, Jing Q, ... Yang Y, Han Y
EuroIntervention: 01 Apr 2021; 16:e1518-e1526 | PMID: 32038026
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Abstract

Effects of coronary sinus Reducer implantation on oxygen kinetics in patients with refractory angina.

Zivelonghi C, Konigstein M, Azzano A, Agostoni P, ... Banai S, Verheye S
Aims
Refractory angina is still a major public health problem. The coronary sinus Reducer (CSR) has recently been introduced as an alternative treatment to reduce symptoms in these patients. The aim of this study was to investigate objective improvements in effort tolerance and oxygen kinetics as assessed by cardiopulmonary exercise testing (CPET) in patients suffering from refractory angina undergoing CSR implantation.
Methods and results
In this multicentre prospective study, patients with chronic refractory angina undergoing CSR implantation were scheduled for CPET before the index procedure and at six-month follow-up. The main endpoints of this analysis were improvements in VO2 max and in VO2 at the anaerobic threshold (AT). Clinical events and improvements in symptoms were also recorded. A total of 37 patients formed the study population. The CSR implantation procedure was successful and without complications in all. At follow-up CPET, significant improvement in VO2 max (+0.97 ml/kg/min [+11.3%]; 12.2±3.6 ml/kg/min at baseline vs 13.2±3.7 ml/kg/min, p=0.026), and workload (+12.9 [+34%]; 68±28 W vs 81±49 W, p=0.05) were observed, with non-significant differences in VO2 at the AT (9.84±3.4 ml/kg/min vs 10.74±3.05 ml/kg/min, p=0.06). Canadian Cardiovascular Society (CCS) grade improved from a mean of 3.2±0.5 to 1.6±0.8 (p<0.01), and significant benefits in all Seattle Angina Questionnaire variables were shown.
Conclusions
In patients with obstructive coronary artery disease suffering from refractory angina, the implantation of a CSR was associated with objective improvement in exercise capacity and oxygen kinetics at CPET, suggesting a possible reduction of myocardial ischaemia.



EuroIntervention: 01 Apr 2021; 16:e1511-e1517
Zivelonghi C, Konigstein M, Azzano A, Agostoni P, ... Banai S, Verheye S
EuroIntervention: 01 Apr 2021; 16:e1511-e1517 | PMID: 32091397
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Abstract

Statistical methods for composite endpoints.

Hara H, van Klaveren D, Kogame N, Chichareon P, ... Onuma Y, Serruys PW
Composite endpoints are commonly used in clinical trials, and time-to-first-event analysis has been the usual standard. Time-to-first-event analysis treats all components of the composite endpoint as having equal severity and is heavily influenced by short-term components. Over the last decade, novel statistical approaches have been introduced to overcome these limitations. We reviewed win ratio analysis, competing risk regression, negative binomial regression, Andersen-Gill regression, and weighted composite endpoint (WCE) analysis. Each method has both advantages and limitations. The advantage of win ratio and WCE analyses is that they take event severity into account by assigning weights to each component of the composite endpoint. These weights should be pre-specified because they strongly influence treatment effect estimates. Negative binomial regression and Andersen-Gill analyses consider all events for each patient -rather than only the first event - and tend to have more statistical power than time-to-first-event analysis. Pre-specified novel statistical methods may enhance our understanding of novel therapy when components vary substantially in severity and timing. These methods consider the specific types of patients, drugs, devices, events, and follow-up duration.



EuroIntervention: 01 Apr 2021; 16:e1484-e1495
Hara H, van Klaveren D, Kogame N, Chichareon P, ... Onuma Y, Serruys PW
EuroIntervention: 01 Apr 2021; 16:e1484-e1495 | PMID: 32338610
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Abstract

Surgical feasibility of ascending aorta manipulation after transcatheter aortic valve implantation: a computed tomography theoretical analysis.

Belluschi I, Buzzatti N, Romano V, De Backer O, ... Montorfano M, Latib A
Aims
The expansion of TAVI will involve an increase in the frequency of emergent or late cardiac surgery after THV implantation. This study was designed to investigate the anatomical feasibility of surgical cross-clamp and aortotomy after TAVI through a post-TAVI CT-scan assessment.
Methods and results
We retrospectively analysed 117 CTs acquired after TAVI procedures with high stent prostheses in three high-volume centres between October 2008 and May 2017. The mean distance observed between the innominate artery and the top of the transcatheter heart valve was 45±11 mm, being <30 mm in 8/117 (6.8%) patients and <20 mm in none. The mean distance between the sinotubular junction and the first free site for aortotomy was 22±7 mm (>20 mm in 78/117 [66.7%] cases). A total of 56/117 (47.9%) patients showed a complete continuous contact between the anterior aortic wall and the anterior part of the valve stent.
Conclusions
Aortic cross-clamp appears not to be an issue when cardiac surgery is needed after TAVI; however, a careful and possibly higher aortotomy may be required. CT should be performed prior to planned cardiac surgery after TAVI to determine a safe positioning for aortic cross-clamp and aortotomy. Visual summary. Proper aortic cross-clamp and careful higher aortotomy after TAVI.



EuroIntervention: 01 Apr 2021; 16:e1533-e1540
Belluschi I, Buzzatti N, Romano V, De Backer O, ... Montorfano M, Latib A
EuroIntervention: 01 Apr 2021; 16:e1533-e1540 | PMID: 32364502
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Abstract

Prioritised endpoints for device-based hypertension trials: the win ratio methodology.

Kandzari DE, Hickey GL, Pocock SJ, Weber MA, ... Lamberti G, Mahfoud F
Aims
Multiple endpoints with varying clinical relevance are available to establish the efficacy of device-based treatments. Given the variance among blood pressure measures and medication changes in hypertension trials, we performed a win ratio analysis of outcomes in a sham-controlled, randomised trial of renal denervation (RDN) in patients with uncontrolled hypertension despite commonly prescribed antihypertensive medications. We propose a novel prioritised endpoint framework for determining the treatment benefit of RDN compared with sham control.
Methods and results
We analysed the SPYRAL HTN-ON MED pilot study data using a prioritised hierarchical endpoint comprised of 24-hour mean ambulatory systolic blood pressure (SBP), office SBP, and medication burden. A generalised pairwise comparisons methodology (win ratio) was extended to examine this endpoint. Clinically relevant thresholds of 5 and 10 mmHg were used for comparisons of ambulatory and office SBP, respectively, and therefore to define treatment \"winners\" and \"losers\". For a total number of 1,596 unmatched pairs, the RDN subject was the winner in 1,050 pairs, the RDN subject was the loser in 378 pairs, and 168 pairs were tied. The win ratio in favour of RDN was 2.78 (95% confidence interval [CI]: 1.58 to 5.48; p<0.001) and corresponding net benefit statistic was 0.42 (95% CI: 0.20 to 0.63). Sensitivity analyses performed with differing blood pressure thresholds and according to drug adherence testing demonstrated consistent results.
Conclusions
The win ratio method addresses prior limitations by enabling inclusion of more patient-oriented results while prioritising those endpoints considered most clinically important. Applying these methods to the SPYRAL HTN-ON MED pilot study (ClinicalTrials.gov Identifier: NCT02439775), RDN was determined to be superior regarding a hierarchical endpoint and a \"winner\" compared with sham control patients.



EuroIntervention: 01 Apr 2021; 16:e1496-e1502
Kandzari DE, Hickey GL, Pocock SJ, Weber MA, ... Lamberti G, Mahfoud F
EuroIntervention: 01 Apr 2021; 16:e1496-e1502 | PMID: 33226002
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Abstract

Optimising physiological endpoints of percutaneous coronary intervention.

Al-Lamee R, Rajkumar CA, Ganesananthan S, Jeremias A
Invasive coronary physiology to select patients for coronary revascularisation has become established in contemporary guidelines for the management of stable coronary artery disease. Compared to revascularisation based on angiography alone, the use of coronary physiology has been shown to improve clinical outcomes and cost efficiency. However, recent data from randomised controlled trials have cast doubt upon the value of ischaemia testing to select patients for revascularisation. Importantly, 20-40% of patients have persistence or recurrence of angina after angiographically successful percutaneous coronary intervention (PCI). This state-of-the-art review is focused on the transitioning role of invasive coronary physiology from its use as a dichotomous test for ischaemia with fixed cut-points, towards its utility for real-time guidance of PCI to optimise physiological results. We summarise the contemporary evidence base for ischaemia testing in stable coronary artery disease, examine emerging indices which allow advanced physiological guidance of PCI, and discuss the rationale and evidence base for post-PCI physiological assessments to assess the success of revascularisation.



EuroIntervention: 01 Apr 2021; 16:e1470-e1483
Al-Lamee R, Rajkumar CA, Ganesananthan S, Jeremias A
EuroIntervention: 01 Apr 2021; 16:e1470-e1483 | PMID: 33792544
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Impact:
Abstract

Proximal Optimisation Technique Versus Final Kissing Balloon Inflation in Coronary Bifurcation Lesions: the Randomised, Multicenter PROPOT Trial.

Watanabe Y, Murasato Y, Yamawaki M, Kinoshita Y, ... Suzuki N, Kozuma K
Background
Clinical implications of proximal optimisation technique (POT) for bifurcation lesions have not been investigated in a randomised controlled trial.
Aims
This study aimed to investigate whether proximal optimisation technique (POT) is superior in terms of stent apposition compared with the conventional kissing balloon technique (KBT) in real-life bifurcation lesions using optical coherence tomography (OCT).
Methods
A total of 120 patients from 15 centres were randomised into two groups: POT followed by side branch dilation or KBT. Finally, 57 and 58 patients in the POT and KBT groups, respectively, were analysed. OCT was performed at baseline, immediately after wire recrossing to the side branch, and at the final procedure.
Results
The primary endpoint was the rate of malapposed struts assessed by the final OCT. The rate of malapposed struts did not differ between the POT and KBT groups (in-stent proximal site: 10.4% vs. 7.7%, p=0.33; bifurcation core: 1.4% vs. 1.1%, p=0.67; core\'s distal edge: 6.2% vs. 5.3%, p=0.59). More additional treatments were required among the POT group (40.4% vs. 6.9%, p&lt;0.01). At 1-year follow-up, only one patient in each group underwent target lesion revascularisation (2.0% vs. 1.9%).
Conclusions
POT followed by side branch dilation did not show any advantages over conventional KBT in terms of stent apposition, however, the excellent mid-term clinical outcomes were observed in both strategies.



EuroIntervention: 29 Mar 2021; epub ahead of print
Watanabe Y, Murasato Y, Yamawaki M, Kinoshita Y, ... Suzuki N, Kozuma K
EuroIntervention: 29 Mar 2021; epub ahead of print | PMID: 33775930
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Impact:
Abstract

Transseptal puncture: procedural guidance, challenging situations and complications management.

Russo G, Taramasso M, Maisano F
A number of interventional procedures based on the transseptal puncture (TSP) have been developed over the last years. The increasing number of interventional procedures, as well as the use of large-bore sheaths and complex devices, has led to improvements in technique and equipment. The combined use of fluoroscopy and of trans-esophageal echocardiography (TEE) has increased safety and precision. However, TSP still represents a tricky procedure, it may become even more difficult in case of challenging interatrial septa and life-threatening complications may occur. Consequently, a deep knowledge of procedural steps, equipment, echocardiographic views, fossa ovalis anatomy and most frequent complications management are critical to perform successful TSP.



EuroIntervention: 29 Mar 2021; epub ahead of print
Russo G, Taramasso M, Maisano F
EuroIntervention: 29 Mar 2021; epub ahead of print | PMID: 33775929
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Impact:
Abstract

Deep sedation versus general anaesthesia for transcatheter mitral valve repair: an individual patient data meta-analysis of observational studies.

Jobs A, Grund S, de Waha-Thiele S, Ledwoch J, ... Eitel I, Thiele H
Aims
The aim of this meta-analysis was to compare general anaesthesia (GA) and deep sedation (DS) with regard to safety and length of intensive care unit (ICU) stay in patients undergoing percutaneous edge-to-edge mitral valve repair (PMVR).
Methods and results
Four studies comparing GA and DS in patients undergoing PMVR were included in an individual patient data meta-analysis. Data were pooled after multiple imputation. The composite safety endpoint of all-cause death, stroke, pneumonia, or major to life-threatening bleeding occurred in 87 of 626 (13.9%) patients with no difference between patients treated with DS as compared to GA (56 and 31 events in 420 and 206 patients, respectively). In this regard, the odds ratio (OR) was 1.27 (95% confidence interval [CI]: 0.78 to 2.09; p=0.338) and 1.26 (95% CI: 0.49 to 3.22; p=0.496) following the one-stage and two-stage approach, respectively. Length of ICU stay was longer after GA as compared to DS (ratio of days 3.08, 95% CI: 2.18 to 4.36, p<0.001, and 2.88, 95% CI: 1.45 to 5.73, p=0.016, following the one-stage and two-stage approach, respectively).
Conclusions
Both DS and GA might offer a similar safety profile. However, ICU stay seems to be shorter after DS.



EuroIntervention: 18 Mar 2021; 16:1359-1365
Jobs A, Grund S, de Waha-Thiele S, Ledwoch J, ... Eitel I, Thiele H
EuroIntervention: 18 Mar 2021; 16:1359-1365 | PMID: 33046436
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Impact:
Abstract

Percutaneous coronary intervention for bifurcation coronary lesions: the 15 consensus document from the European Bifurcation Club.

Burzotta F, Lassen JF, Lefèvre T, Banning AP, ... Louvard Y, Stankovic G
The 15th European Bifurcation Club (EBC) meeting was held in Barcelona in October 2019. It facilitated a renewed consensus on coronary bifurcation lesions (CBL) and unprotected left main (LM) percutaneous interventions. Bifurcation stenting techniques continue to be refined, developed and tested. It remains evident that a provisional approach with optional side branch treatment utilising T, T and small protrusion (TAP) or culotte continues to provide flexible options for the majority of CBL patients. Debate persists regarding the optimal treatment of side branches, including assessment of clinical significance and thresholds for bail-out treatment. In more complex CBL, especially those involving the LM, adoption of dedicated two-stent techniques should be considered. Operators using such techniques have to be fully familiar with their procedural steps and should acknowledge associated limitations and challenges. When using two-stent techniques, failure to perform a final kissing inflation is regarded as a technical failure, since it may jeopardise clinical outcome. The development of novel technical tools and drug regimens deserves attention. In particular, intracoronary imaging, bifurcation simulation, drug-eluting balloon technology and tailored antiplatelet therapy have been identified as promising tools to enhance clinical outcomes. In conclusion, the evolution of a broad spectrum of bifurcation PCI components has resulted from studies extending from bench testing to randomised controlled trials. However, further advances are still needed to achieve the ambitious goal of optimising the clinical outcomes for every patient undergoing PCI on a CBL. Visual summary. 15th consensus document from the European Bifurcation Club.



EuroIntervention: 18 Mar 2021; 16:1307-1317
Burzotta F, Lassen JF, Lefèvre T, Banning AP, ... Louvard Y, Stankovic G
EuroIntervention: 18 Mar 2021; 16:1307-1317 | PMID: 33074152
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Impact:
Abstract

Age and Functional Relevance of Coronary Stenosis: a Post-Hoc Analysis of the ADVISE II Trial.

Faria DC, Lee JM, van der Hoef T, Mejía-Rentería H, ... Lerman A, Escaned J
Background
The influence of age-dependent changes on fractional flow reserve (FFR) or instantaneous free-wave ratio (iFR) and the response to pharmacological hyperaemia has not been investigated.
Aims
We investigated the impact of age on these indices.
Methods
This is as post-hoc analysis of the ADVISE II trial, including a total of 690 pressure recordings (in 591 patients). Age-dependent correlations with FFR and iFR were calculated and adjusted for stenosis severity. Patients were stratified into three age terciles. The hyperaemic response to adenosine, calculated as the difference between resting and hyperaemic pressure ratios, and the prevalence of FFR-iFR discordance were assessed.
Results
Age correlated positively with FFR (r=0.08, 95% CI: 0.01 to 0.15, p=0.015), but not with iFR (r=-0.03, 95% CI: -0.11 to 0.04, p=0.411). The hyperaemic response to adenosine decreased with patient age (0.12 ± 0.07, 0.11 ± 0.06, 0.09 ± 0.05, for the 1st[33-58 years], 2nd[59-69 years] and 3rd[70-94 years] age tertiles, respectively, p&lt;0.001) and showed significant correlation with age (r=-0.14, 95% CI -0.21 to -0.06, p&lt;0.001). The proportion of patients with FFR≤0.80 + iFR&gt;0.89 discordance doubled in the first age-tercile (14.1% vs 7.1% vs 7.0%, p=0.005).
Conclusions
The hyperaemic response of the microcirculation to adenosine administration is age-dependent. FFR values increase with patient age, while iFR values remain constant across the age spectrum. These findings contribute to explain differences observed in functional stenosis classification with hyperaemic and non-hyperaemic coronary indices.



EuroIntervention: 15 Mar 2021; epub ahead of print
Faria DC, Lee JM, van der Hoef T, Mejía-Rentería H, ... Lerman A, Escaned J
EuroIntervention: 15 Mar 2021; epub ahead of print | PMID: 33720019
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Impact:
Abstract

Long-Term Outcomes of Catheter-Based Intervention for Clinically Significant Paravalvular Leak.

Perl L, Cohen A, Dadashev A, Shapira Y, ... Kornowski R, Hirsch R
Background
In most centers, clinically significant percutaneous paravalvular leak (PVL) closure following valve replacement surgery is reserved for those considered high-risk for surgery. There is paucity of data regarding long-term outcomes of these patients.
Aims
Our goals were to assess long-term outcomes of patients undergoing percutaneous PVL closure.
Methods
100 consecutive transcatheter PVL closure procedures (74 mitral, 26 aortic) were performed in 95 patients between February 2005 and august 2019 at our hospital. Data collected included: procedural success rates, indication-specific outcomes and mortality.
Results
Mean follow-up was 5.6±6.1 years, mean age 62.6±15.2, 45.4 % were female. The device was successfully implanted in 88 procedures (88.0%). Patients who presented with heart failure (n-57) had a significant improvement in the NYHA classification (29.2% class 3/4 versus 100.0%, P&lt;0.001). For patients who presented with hemolytic anemia (n-38), hemoglobin increased (11.94±1.634 vs. 9.72±1.49, P&lt;0.001) and LDH levels were reduced (1,354.90±1,225.55 vs. 2,039.40±1,347.20, P&lt;0.001) following the procedure. Rates of mortality were 3.8% at 90 days, 15.6% after one year, and 27.2% after 5 years.
Conclusions
For patients who are deemed intermediate to high-risk for repeat surgery, transcatheter PVL closure shows reasonable clinical success rates, with a significant improvement in symptoms, and a relatively low rate of periprocedural complications.



EuroIntervention: 15 Mar 2021; epub ahead of print
Perl L, Cohen A, Dadashev A, Shapira Y, ... Kornowski R, Hirsch R
EuroIntervention: 15 Mar 2021; epub ahead of print | PMID: 33720018
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Impact:
Abstract

Occlusion Patterns, Strategies and Procedural Outcomes of Percutaneous Coronary Intervention for In-Stent Chronic Total Occlusion.

Sekiguchi M, Muramatsu T, Kishi K, Sumitsuji S, ... Tanaka H, Tsuchikane E
Background
In-stent chronic total occlusion (CTO) presents various occlusion patterns, which complicate percutaneous coronary intervention (PCI).
Aims
To investigate the initial outcome and strategy of PCI for in-stent CTO according to the angiographic occlusion patterns.
Methods
This study assessed 791 in-stent CTOs from the Japanese CTO-PCI Expert Registry from 2015 to 2018. They were divided into 4 patterns: Pattern A (n = 419), CTO within the stent segment; pattern B (n = 196), CTO beyond the distal edge; pattern C (n = 85), CTO beyond the proximal edge; and pattern D (n = 69) CTO beyond both the proximal and distal edges.
Results
There were significant differences in the technical success rates (96.2%, 86.2%, 92.9%, and 75.4% for patterns A-D respectively; P &lt; 0.001), guidewire crossing times (22 (interquartile range: 10-46), 52 (24-102), 40 (45-78), and 86 (45-127) min, respectively; P &lt; 0.001), and the rates of antegrade approach alone (90.9%, 61.2%, 67.1%, and 31.9%, respectively; P &lt; 0.001).
Conclusions
PCI for CTO within the stent segment was associated with excellent initial outcomes with the antegrade approach. However, PCI for CTO beyond both the proximal and distal edges was associated with the poorest outcomes, even with the bidirectional approach.



EuroIntervention: 15 Mar 2021; epub ahead of print
Sekiguchi M, Muramatsu T, Kishi K, Sumitsuji S, ... Tanaka H, Tsuchikane E
EuroIntervention: 15 Mar 2021; epub ahead of print | PMID: 33720017
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Impact:
Abstract

Fate of Tricuspid Regurgitation in Patients Undergoing Transcatheter Edge-to-Edge Mitral Valve Repair.

Kavsur R, Iliadis C, Spieker M, Brachtendorf BM, ... Westenfeld R, Becher MU
Background
Mitral valve repair may lead to alterations of tricuspid regurgitation (TR).
Aims
We investigated alterations, predictors and prognostic relevance of TR evolution in a large-scale multicentre population of patients undergoing transcatheter mitral valve repair (TMVR) via MitraClip.
Methods
In total, we included 531 TMVR-patients with at least one available follow-up echocardiography. TR-improvement was defined as a TR ≥II at baseline, which showed a decline of at least one TR-categorization.
Results
Distribution of pre-procedural TR severity was TR0/I 41% (220/531), TRII 39% (209/531) and TR≥III 19% (102/531), respectively. Follow-up echocardiography was at 308±187days. TR severity improved to TR0/I 49% (259/531), TRII 35% (183/531) and TRIII 17% (89/531), p=0.003. Out of 311 patients with TR≥II at baseline, 41% (127/311) showed TR-improvement. Atrial fibrillation (AF), residual mitral regurgitation ≥II (rMR) and tricuspid annular diameter (TAD) remained variables which prevented TR-improvement [odds ratio 0.49(0.29-0.84), 0.47(0.27-0.81) &amp; 0.97(0.93-0.997), respectively]. TR-improvement was associated with better event-free survival regarding post-procedural heart-failure hospitalization (HHF) [hazard ratio 0.6(0.38-0.94)]. The main changes of TR-severity occurred within 3-month post TMVR (p=0.006), while there were only minor TR-changes between 3 and 12-month of follow-up (p=0.813).
Conclusions
TR-improvement was frequent after TMVR. Predictors preventing TR-improvement were AF, post-procedural rMR, and TAD. Furthermore, TR-improvement was an early phenomenon primarily occurring within the first three months post TMVR and served as a suitable marker of reduced HHF.



EuroIntervention: 01 Mar 2021; epub ahead of print
Kavsur R, Iliadis C, Spieker M, Brachtendorf BM, ... Westenfeld R, Becher MU
EuroIntervention: 01 Mar 2021; epub ahead of print | PMID: 33646125
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Impact:
Abstract

Clinical and angiographic outcomes of crossing techniques for coronary chronic total occlusions - The ISAR-CTO Registry.

Xhepa E, Cassese S, Ndrepepa G, Joner M, ... Kastrati A, Fusaro M
Background
Clinical and angiographic outcomes following recanalization of coronary chronic total occlusions (CTO) through contemporary dissection and reentry techniques (DART) as opposed to intraplaque techniques remain controversial.
Aims
To compare clinical and angiographic outcomes following subintimal and intraplaque CTO recanalization.
Methods
453 consecutive patients undergoing successful CTO recanalization (473 vessels) were included. Intraplaque techniques were used in 403 (85.2%) and DART in 70 (14.8%) vessels. Surveillance angiography was scheduled at 6-9 months and clinical follow-up was performed up to 12 months.
Results
No significant differences in terms of cumulative incidence of MACE (P=0.862) or binary restenosis (P=0.320) were present between the two groups. There was no independent correlation between recanalization technique and MACE occurrence or in-segment binary restenosis. Target lesion revascularization (TLR) was performed in 60 (15.5%) and 12 (17.9%) (P=0.678) lesions respectively. The occurrence of occlusive restenosis was low [7 (2.3%) vs. 1 (1.6%); P=0.824] and comparable between groups.
Conclusions
Contemporary DART are associated with similar mid-term clinical and angiographic outcomes compared to intraplaque recanalization. Rate of occlusive restenosis was low and comparable in both groups. Regardless of recanalization technique, overall incidence of binary restenosis and TLR following CTO recanalization remain higher than those reported for non-CTO PCI.



EuroIntervention: 01 Mar 2021; epub ahead of print
Xhepa E, Cassese S, Ndrepepa G, Joner M, ... Kastrati A, Fusaro M
EuroIntervention: 01 Mar 2021; epub ahead of print | PMID: 33646124
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Impact:
Abstract

A review of recommendations for infective endocarditis prevention in patients undergoing transcatheter aortic valve implantation.

Conen A, Stortecky S, Moreillon P, Hannan MM, ... Jeger R, Widmer AF
Infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI) is a new disease entity. The rate of IE after TAVI is similar to that after surgical aortic valve replacement (SAVR), but mortality and prevalence of Enterococcus spp. as causing pathogens are significantly higher. Guidelines on infection prevention measures before TAVI procedures are currently lacking. We performed a structured review of the available data to provide interim recommendations based on guidelines to prevent infections issued by the World Health Organization as well as guidelines by professional societies from Europe and the USA. Such interim recommendations based on expert opinions are probably justified until large randomised trials provide strong evidence for infection control in TAVI, because IE after TAVI is often related to the TAVI procedure itself and the associated mortality rate is high. Antibiotic prophylaxis should be adapted from an intravenous cephalosporin to, e.g., amoxicillin/clavulanic acid, to cover enterococci. In addition, infection control should follow operating room standards as far as is reasonable, even if the evidence for this recommendation is very low. These recommendations are endorsed by the International Society for Cardiovascular Infectious Diseases (ISCVID).



EuroIntervention: 18 Feb 2021; 16:1135-1140
Conen A, Stortecky S, Moreillon P, Hannan MM, ... Jeger R, Widmer AF
EuroIntervention: 18 Feb 2021; 16:1135-1140 | PMID: 32207407
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Impact:
Abstract

A prospective, multicentre, randomised, open-label trial to compare the efficacy and safety of clopidogrel versus ticagrelor in stabilised patients with acute myocardial infarction after percutaneous coronary intervention: rationale and design of the TALOS-AMI trial.

Park MW, Kim CJ, Kim MC, Choo EH, ... Ahn Y, Chang K
Aims
In patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI), the risk of ischaemic complications is highest in the early phase (during the first 30 days), while most bleeding events occur predominantly during the maintenance phase of treatment (after the first 30 days). Data on the de-escalation of dual antiplatelet therapy by switching from ticagrelor to clopidogrel in stabilised AMI patients are limited. The aim of this study is to investigate the efficacy and safety of switching from ticagrelor to clopidogrel in AMI patients with no adverse event during the first month after the index PCI with newer-generation DES.
Methods and results
TALOS-AMI is a multicentre, randomised, open-label study enrolling 2,590 AMI patients with no adverse events during the first month after the index PCI. One month after the index PCI, eligible patients are randomly assigned either to 1) aspirin 100 mg plus clopidogrel 75 mg daily, or to 2) aspirin 100 mg plus ticagrelor 90 mg twice daily, in a 1:1 ratio. The primary endpoint is a composite of cardiovascular death, MI, stroke, and bleeding type 2, 3 or 5 according to the Bleeding Academic Research Consortium (BARC) criteria from 1 to 12 months after the index PCI.
Conclusions
The TALOS-AMI trial is the first large-scale, multicentre, randomised study exploring the efficacy and safety of the de-escalation of antiplatelet therapy by switching from ticagrelor to clopidogrel in stabilised AMI patients undergoing PCI.



EuroIntervention: 18 Feb 2021; 16:1170-1176
Park MW, Kim CJ, Kim MC, Choo EH, ... Ahn Y, Chang K
EuroIntervention: 18 Feb 2021; 16:1170-1176 | PMID: 32718912
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Impact:
Abstract

High bleeding risk and clinical outcomes in East Asian patients undergoing percutaneous coronary intervention: the PENDULUM registry.

Nakamura M, Kadota K, Nakao K, Nakagawa Y, ... Kuroda T, Murakami Y
Aims
We aimed to evaluate the validity of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria for East Asian patients undergoing contemporary percutaneous coronary intervention (PCI) from the PENDULUM registry.
Methods and results
This post hoc analysis included 6,267 Japanese patients undergoing PCI between December 2015 and June 2017 enrolled in PENDULUM. The primary endpoint was the incidence of major bleeding at 12 months post index PCI. In total, 3,185 (50.8%) and 3,082 (49.2%) patients were stratified to the ARC-HBR and non-ARC-HBR groups, respectively, and almost all patients had overlapping criteria. Incidence of major bleeding was 4.2% versus 1.4% in the ARC-HBR group versus the non-ARC-HBR group (hazard ratio 3.00 [95% confidence interval: 2.11-4.27]; p<0.001). As the number of overlapping ARC-HBR criteria increased, the incidence of major bleeding also increased. In contrast, the incidence of major bleeding was 4.2% for one major criterion, 2.1% for two minor criteria. Multivariate analysis suggested that severe CKD, anticoagulant use, acute coronary syndrome, low body weight and heart failure were independent predictors of major bleeding.
Conclusions
Half of the Japanese patients who underwent PCI in the PENDULUM registry met the ARC-HBR criteria, and many patients had overlapping criteria. ARC-HBR criteria are applicable to Japanese patients undergoing contemporary PCI.



EuroIntervention: 18 Feb 2021; 16:1154-1162
Nakamura M, Kadota K, Nakao K, Nakagawa Y, ... Kuroda T, Murakami Y
EuroIntervention: 18 Feb 2021; 16:1154-1162 | PMID: 32624464
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Impact:
Abstract

Heterogeneity of debris captured by cerebral embolic protection filters during TAVI.

Kroon H, von der Thusen JH, Ziviello F, van Wiechen M, ... de Jaegere P, Van Mieghem NM
Aims
The aim of this study was to investigate the total amount, size and heterogeneity of debris captured among different transcatheter valve types and while repositioning.
Methods and results
A total of 328 patients who underwent transcatheter aortic valve implantation (TAVI) with the SENTINEL cerebral embolic protection (CEP) at our centre were eligible. Histopathological and semiquantitative analysis of captured debris was performed and data were entered into our prospective database. TAVI was performed with either the Evolut R/PRO (N=123), SAPIEN 3 (N=113) or Lotus valve (N=92). Capture of debris occurred in 98% of patients. Lotus TAVI resulted in more frequent foreign body material (62% vs 40% vs 47%, p=0.006), endothelium (49% vs 30% vs 16%, p<0.0005), calcified material (33% vs 12% vs 24%, p=0.001) and myocardial tissue (19% vs 11% vs 2%, p<0.0005) compared to SAPIEN 3 or Evolut R/PRO. Native (functional) bicuspid valves (OR 2.91, 95% CI: 1.20-7.03, p=0.02) and Lotus (OR 2.44, 95% CI: 1.14-5.24, p=0.02) were associated with the highest risk for dislodging particles ≥1,000 um. Valve repositioning was independently associated with larger amounts of debris (OR 2.96, 95% CI: 1.42-6.16, p=0.004).
Conclusions
All THV platforms had similar amounts of captured debris. THV repositioning seemed to be associated with a higher risk for dislodging greater amounts of debris to the brain. Visual summary. Aetiopathology of debris captured by cerebral embolic protection filters during TAVI, including risk factors for greater amounts or larger particles of debris.



EuroIntervention: 18 Feb 2021; 16:1141-1147
Kroon H, von der Thusen JH, Ziviello F, van Wiechen M, ... de Jaegere P, Van Mieghem NM
EuroIntervention: 18 Feb 2021; 16:1141-1147 | PMID: 32894232
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Impact:
Abstract

Performing elective cardiac invasive procedures during the COVID-19 outbreak: a position statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

Chieffo A, Tarantini G, Naber CK, Barbato E, ... Baumbach A, Dudek D
The rearrangement of healthcare services required to face the coronavirus disease 2019 (COVID-19) pandemic led to a drastic reduction in elective cardiac invasive procedures. We are already facing a \"second wave\" of infections and we might be dealing during the next months with a \"third wave\" and subsequently new waves. Therefore, during the different waves of the COVID-19 pandemic we have to face the problems of how to perform elective cardiac invasive procedures in non-COVID patients and which patients/procedures should be prioritised. In this context, the interplay between the pandemic stage, the availability of healthcare resources and the priority of specific cardiac disorders is crucial. Clear pathways for \"hot\" or presumed \"hot\" patients and \"cold\" patients are mandatory in each hospital. Depending on the local testing capacity and intensity of transmission in the area, healthcare facilities may test patients for SARS-CoV-2 infection before the interventional procedure, regardless of risk assessment for COVID-19. Pre-hospital testing should always be conducted in the presence of symptoms suggestive of SARS-CoV-2 infection. In cases of confirmed or suspected COVID-19 positive patients, full personal protective equipment using FFP 2/N95 masks, eye protection, gowning and gloves is indicated during cardiac interventions for healthcare workers. When patients have tested negative for COVID-19, medical masks may be sufficient. Indeed, individual patients should themselves wear medical masks during cardiac interventions and outpatient visits.



EuroIntervention: 18 Feb 2021; 16:1177-1186
Chieffo A, Tarantini G, Naber CK, Barbato E, ... Baumbach A, Dudek D
EuroIntervention: 18 Feb 2021; 16:1177-1186 | PMID: 33416050
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Impact:
Abstract

Effectiveness of Upfront Combined Strategy for Endovascular Hemostasis in Transfemoral Transcatheter Aortic Valve Implantation.

Costa G, Valvo R, Picci A, Criscione E, ... Tamburino C, Barbanti M
Background
Vascular complications still represent an important issue after transcatheter aortic valve implantation (TAVI).
Aims
To evaluate the effectiveness of upfront use of an adjunctive Angio-Seal (AS) plug-based system on top of suture-based devices (SBDs) for endovascular hemostasis after transfemoral (TF) TAVI.
Methods
From January 2019 to April 2020, 332 consecutive patients with pre-procedural computed tomography angiography (CTA) assessment underwent fully percutaneous TF-TAVI. The primary outcomes were 30-day major vascular complications and major or life-threatening (LT) bleeding due to endovascular closure system failure. A total of 246 TF-TAVI patients (123 pairs), undergoing either isolated SBD or SBD+AS were matched using propensity-score method.
Results
At 30 days, patients receiving SBD+AS had lower rates of major/life-threatening bleeding [1.6% vs. 8.9%; odds ratio (OR) 0.17, 95% confidence interval (CI) 0.04-0.78;p&lt;0.01] and major vascular complications (1.6% vs. 8.9%; OR 0.17, 95% CI 0.04-0.78; p&lt;0.01). In addition, the use of SBD+AS was associated with a significantly costs saving related to the vascular event [mean difference -315.3€ per patient, 95% CI (-566.4€)-(-64.1€);p=0.01], and a higher probability of next-day discharge (NDD) after TAVI (30.9% vs. 16.3%; OR 2.30, 95% CI 1.25-4.25;p&lt;0.01). No difference in all-cause 30-day mortality was observed (3.3% vs. 1.6% for SBD and SBD+AS groups, respectively; OR 0.49, 95% CI 0.09-2.74;p=0.41).
Conclusions
An upfront combined strategy with an additional AS plug-based device on top of SBDs showed to reduce major vascular complications and major/LT bleeding due to closure system failure after TF-TAVI. This approach was associated with a cost saving and with a higher probability of NDD compared to the use of isolated SBD.



EuroIntervention: 15 Feb 2021; epub ahead of print
Costa G, Valvo R, Picci A, Criscione E, ... Tamburino C, Barbanti M
EuroIntervention: 15 Feb 2021; epub ahead of print | PMID: 33589411
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Impact:
Abstract

Outcomes of Retrograde Approach for Chronic Total Occlusions by Guidewire Location.

Fan Y, Maehara A, Yamamoto MH, Hakemi EU, ... Leon MB, Stone GW
Background
Connecting antegrade wire (AW) and retrograde wire (RW) is a goal of chronic total occlusion (CTO) treatment, but angiographic guide wire location is sometimes misleading.
Aims
To evaluate the association between intravascular ultrasound (IVUS) defined AW and RW position and procedural outcomes when treating CTO lesions using retrograde approach.
Methods
Overall, 191 CTO lesions treated with IVUS-guided retrograde approach at three centers in Japan, China, and United States were included.
Results
When the AW and RW angiographically overlapped, four wire positions were seen by IVUS: (i) AW within the plaque (AW-intraplaque) and RW-intraplaque in 34%; (ii) AW-intraplaque and RW in the subintimal space (RW-subintima) in 28%; (iii) AW-subintima and RW-subintima in 22%; or (iv) AW-subintima and RW-intraplaque in 16%. The procedure succeeded without repositioning the wire in 89% of AW-intraplaque/RW-intraplaque, 61% of AW-intraplaque/RW-subintima and 57% of AW-subintima/RW-subintima, but only one (3%) AW-subintima/RW-intraplaque. Lesion and procedure complexity and failure/complications were greatest in AW-subintima/RW-intraplaque.
Conclusions
IVUS-identified vascular compartment concordance versus IVUS-identified vascular compartment mismatch leads to higher success rates irrespective of intra-plaque or sub-intimal passage . AW-subintima/RW-intraplaque was associated with the most complex CTO morphology and procedure and repositioning the wire was almost always necessary.



EuroIntervention: 15 Feb 2021; epub ahead of print
Fan Y, Maehara A, Yamamoto MH, Hakemi EU, ... Leon MB, Stone GW
EuroIntervention: 15 Feb 2021; epub ahead of print | PMID: 33589409
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Impact:
Abstract

Outcomes of Transcatheter Mitral Valve Repair for Secondary Mitral Regurgitation by Severity of Left Ventricular Dysfunction.

Lerakis S, Kini AS, Asch FM, Kar S, ... Mack MJ, Stone GW
Background
In the COAPT trial, transcatheter mitral valve repair with MitraClip plus maximally-tolerated guideline-directed medical therapy (GDMT) improved clinical outcomes compared with GDMT alone in symptomatic patients with heart failure (HF) and 3+ or 4+ secondary mitral regurgitation (SMR) due to left ventricular (LV) dysfunction.
Aims
In this COAPT substudy we sought to evaluate 2-year outcomes in HF patients with reduced LV ejection fraction (HFrEF; LVEF £40%) versus preserved LVEF (HFpEF; LVEF &gt;40%) and in those with severe (LVEF £30%) versus moderate (LVEF &gt;30%) LV dysfunction.
Methods
The principal effectiveness outcome was the 2-year rate of death from any cause or HF hospitalizations (HFH). Subgroup analysis with interaction testing performed according to baseline LVEF; 472 patients (82.1%) had HFrEF (mean LVEF 28.0%±6.2%; range 12% to 40%) and 103 (17.9%) had HFpEF (mean LVEF 46.6%±4.9%; range 41% to 65%), while 292 (50.7%) had severely depressed LVEF (LVEF ≤30%; mean LVEF 23.9% ± 3.8%) and 283 (49.3%) had moderately depressed LVEF (LVEF &gt;30%; mean LVEF 39.0% ± 6.8%).
Results
The 2-year rate of death or HFH was 56.7% in patients with HFrEF and 53.4% with HFpEF (HR 1.16, 95%CI 0.86-1.57, p=0.32). MitraClip reduced the 2-year rate of death or HFH in patients with HFrEF (HR 0.50, 95%CI 0.39-0.65) and HFpEF (HR 0.60, 95%CI 0.35-1.05), pint=0.55. MitraClip was consistently effective in reducing the individual endpoints of mortality and HFH, improving MR severity, quality-of-life, and 6-minute walk distance in patients with HFrEF, HFpEF, LVEF &lt;30%, and LVEF &gt;30%.
Conclusions
In the COAPT trial, among patients with HF and 3+ or 4+ SMR who remained symptomatic despite maximally-tolerated GDMT, MitraClip was consistently effective in improving survival and health status in patients with severe and moderate LV dysfunction and preserved LVEF.



EuroIntervention: 15 Feb 2021; epub ahead of print
Lerakis S, Kini AS, Asch FM, Kar S, ... Mack MJ, Stone GW
EuroIntervention: 15 Feb 2021; epub ahead of print | PMID: 33589408
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Abstract

Cardiovascular mortality and morbidity in patients undergoing percutaneous coronary intervention after out-of-hospital cardiac arrest: a systematic review and meta-analysis.

Spirito A, Gargiulo G, Siontis GCM, Mitsis A, ... Windecker S, Valgimigli M
Aims
The aim of this meta-analysis was to appraise the burden of cardiovascular mortality and morbidity among patients undergoing percutaneous coronary intervention (PCI) after out-of-hospital cardiac arrest (OHCA).
Methods and results
This was a meta-analysis of studies assessing the cardiovascular mortality or at least one other pre-defined outcome in OHCA patients undergoing PCI. Forty-nine studies with a total of 301,902 patients (73,634 OHCA and 228,268 non-OHCA patients) were included. Compared to non-OHCA patients, all-cause mortality was higher in OHCA patients (29% vs 4%). The cause of 39% of deaths among OHCA patients was cardiovascular: PCI was more frequently unsuccessful (9.2% vs 7.6%) and there were higher rates of stent thrombosis (2.9% vs 0.8%), myocardial infarction (1.7% vs 1.4%), relevant bleeding (10.2% vs 2.1%) and stroke (1.7% vs 0.5%). OHCA patients compared to non-OHCA patients had a higher risk of all-cause mortality (risk ratio [RR] 6.4, 95% CI: 5.5-7.4), cardiovascular death (4.6, 1.1-19), unsuccessful coronary revascularisation (1.4, 1.1-1.7), stent thrombosis (3.8, 0.6-22.7), myocardial infarction (1.4, 1.1-1.7), relevant bleeding (3.2, 2.5-4.1) and stroke (3.1, 2.3-4.3).
Conclusions
Almost one third of OHCA patients undergoing PCI die and more than one third of the fatalities are attributable to cardiovascular causes. The burden of ischaemic and bleeding complications was consistently higher and the success rates of PCI lower among OHCA as compared to non-OHCA patients.



EuroIntervention: 04 Feb 2021; 16:e1245-e1253
Spirito A, Gargiulo G, Siontis GCM, Mitsis A, ... Windecker S, Valgimigli M
EuroIntervention: 04 Feb 2021; 16:e1245-e1253 | PMID: 32624462
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Abstract

Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study.

Nickenig G, Weber M, Schüler R, Hausleiter J, ... Hahn RT, Maisano F
Aims
Tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report one- and two-year outcomes of the Cardioband tricuspid valve reconstruction system in the treatment of ≥moderate functional TR in the TRI-REPAIR study.
Methods and results
Thirty patients were enrolled in this single-arm, multicentre, prospective study. Patients were evaluated as having ≥moderate, symptomatic functional TR and deemed inoperable due to unacceptable surgical risk. Clinical, functional, and echocardiographic data were prospectively collected up to two years (mean duration 604±227 days). At baseline, 83% were in NYHA Class III-IV, and the mean LVEF was 58%. Technical success was 100%. At two years, there were eight deaths. Echocardiography showed a significant reduction in septolateral annular diameter of 16% (p=0.006) and 72% of patients (p=0.016) with ≤moderate TR grade; 82% of patients were in NYHA Class I-II (p=0.002). Six-minute walk distance and KCCQ score improved by 73 m (p=0.058) and 14 points (p=0.046), respectively.
Conclusions
These results demonstrate that the Cardioband tricuspid system showed favourable results in patients with symptomatic, ≥moderate functional TR. Annular reduction and TR severity reduction remained significant and sustained at two years. Patients experienced improvements in quality of life and exercise capacity. ClinicalTrials.gov Identifier: NCT02981953.



EuroIntervention: 04 Feb 2021; 16:e1264-e1271
Nickenig G, Weber M, Schüler R, Hausleiter J, ... Hahn RT, Maisano F
EuroIntervention: 04 Feb 2021; 16:e1264-e1271 | PMID: 33046437
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Abstract

Pulmonary ridge coverage and device-related thrombosis after left atrial appendage occlusion.

Freixa X, Cepas-Guillen P, Flores-Umanzor E, Regueiro A, ... Sitges M, Sabaté M
Aims
The aim of this study was to evaluate the impact of pulmonary ridge (PR) coverage on both clinical and imaging follow-up outcomes in patients undergoing left atrial appendage occlusion (LAAO).
Methods and results
The study included consecutive patients with non-valvular atrial fibrillation who underwent LAAO with disc and lobe devices. Patients were classified into two groups according to the PR coverage. A total of 147 patients were included. Among these, the PR was covered in 109 (74%) and uncovered in 38 (26%). Successful implantation was achieved in 98.6%. No differences in procedural outcomes were observed between the groups. The rate of procedural major adverse events was 3% (only major bleedings and/or vascular access complications). No device embolisation, cardiac tamponade or in-hospital mortality was observed. After a mean follow-up of 1.77±2.2 years, the annualised ischaemic stroke and major bleeding rate was 1.3%/year and 6.5%/year, respectively, without differences between groups. At follow-up, patients with a covered PR presented a lower incidence of device-related thrombosis (DRT) (1%) than those with an uncovered PR (27%); p<0.001. In multivariable analysis, the presence of PR coverage emerged as an independent predictor of DRT.
Conclusions
Pulmonary ridge coverage was associated with a lower incidence of DRT after LAAO. Procedural and follow-up clinical outcomes did not differ between covered PR and uncovered PR patients.



EuroIntervention: 04 Feb 2021; 16:e1288-e1294
Freixa X, Cepas-Guillen P, Flores-Umanzor E, Regueiro A, ... Sitges M, Sabaté M
EuroIntervention: 04 Feb 2021; 16:e1288-e1294 | PMID: 33164895
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This program is still in alpha version.