Journal: EuroIntervention

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Abstract

Anatomical Attributes of Clinically Relevant Diagonal Branches in Patients with Left Anterior Descending Coronary Artery Bifurcation Lesions.

Jeon WK, Park J, Koo BK, Suh M, ... Yang HM, Park KW
Aims
This study aimed to investigate the anatomical attributes determining myocardial territory of diagonal branches and to develop prediction models for clinically relevant branches using myocardial perfusion imaging (MPI) and coronary CT angiography (CCTA).
Methods and results
The amount of ischemia and subtended myocardial mass of diagonal branches were quantified using MPI by percent ischemic myocardium (%ischemia) and CCTA by percent fractional myocardial mass (%FMM), respectively. In 49 patients with isolated diagonal branch disease, the mean %ischemia by MPI was 6.8±4.0% whereas in patients with total occlusion or severe disease of all diagonal branches, it was 8.4±3.3%. %ischemia was different according to the presence of non-diseased diagonal branches and dominant left circumflex artery (LCx). In CCTA cohort (306 patients, 564 diagonal branches), mean %FMM was 5.9±4.4% and 86 branches (15.2%) had %FMM ≥10%. %FMM was different according to LCx dominance, number of branches, vessel size, and relative dominance between 2 diagonal branches. The diagnostic accuracies of prediction models for %FMM ≥10% based on logistic regression and decision tree were 0.92 (95% CI 0.85-0.96) and 0.91 (95% CI 0.84-0.96), respectively. There was no difference in the diagnostic performance of models with and without size criterion.
Conclusions
LCx dominance, number of branches, vessel size, and dominance among diagonal branches determined the myocardial territory of diagonal branches. Clinical application of prediction models based on these anatomical attributes can help determine the clinically relevant diagonal branches in the cardiac catheterization laboratory.



EuroIntervention: 11 Nov 2019; epub ahead of print
Jeon WK, Park J, Koo BK, Suh M, ... Yang HM, Park KW
EuroIntervention: 11 Nov 2019; epub ahead of print | PMID: 31719001
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Abstract

Detection of Optical Coherence Tomography-Defined Thin-Cap Fibroatheroma in the Coronary Artery Using Deep Learning.

Min HS, Yoo JH, Kang SJ, Lee JG, ... Park SW, Park SJ
Aims
To develop a deep learning model for classifying frames with vs. without optical coherence tomography (OCT)-derived thin-cap fibroatheroma (TCFA).
Methods and results
Total 602 coronary lesions from 602 angina patients were randomized into training and test sets at a 4:1 ratio. A DenseNet model was developed to classify OCT frames with or without OCT-derived TCFA. Gradient-weighted class activation mapping was used to visualize the area of attention. In the training sample (35,678 frames of 480 lesions), the model with 5-fold cross-validation had an overall accuracy of 91.6±1.7%, sensitivity of 88.7±3.4%, and specificity of 91.8±2.0% (averaged AUC=0.96±0.01) in predicting the presence of TCFA. In the test samples (9,722 frames of 122 lesions), the overall accuracy at the frame level was 92.8% within the lesion (AUC=0.96) and 91.3% in the entire OCT pullback. The correlation between the %TCFA burdens per vessel predicted by the model compared with that identified by experts was significant (r=0.87, p<0.001). The region of attention was localized at the site of the thin cap in 93.4% of TCFA-containing frames. Total computational time per a pullback was 2.1 ± 0.3 seconds.
Conclusions
Deep learning algorithm can accurately detect an OCT-TCFA with a high reproducibility. The time-saving computerized process may assist clinicians to easily recognize high-risk lesions and to make decisions in the catheterization laboratory.



EuroIntervention: 11 Nov 2019; epub ahead of print
Min HS, Yoo JH, Kang SJ, Lee JG, ... Park SW, Park SJ
EuroIntervention: 11 Nov 2019; epub ahead of print | PMID: 31718998
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Abstract

Comparison of cardiac computed tomography angiography and transoesophageal echocardiography for device surveillance after left atrial appendage closure.

Qamar SR, Jalal S, Nicolaou S, Tsang M, Gilhofer T, Saw J
Aims
Device surveillance after left atrial appendage (LAA) closure (LAAC) is important to assess device positioning, peri-device leak (PDL) and device-related thrombus (DRT). There are limited data on the role of cardiac CT angiography (CCTA) after LAAC. We therefore sought to compare CCTA to transoesophageal echocardiography (TEE) in patients who successfully underwent LAAC.
Methods and results
We report our consecutive series of non-valvular atrial fibrillation patients who underwent LAAC and had CCTA and TEE post LAAC. Prospective cardiac-gated CCTA was performed with the Toshiba 320-detector or Siemens second-generation 128-slice dual-source scanner, and post-processing was performed with IMPAX 3D reformats. Glomerular filtration rate <30 mL/min/1.73 m² was an exclusion for CCTA. Device positioning, PDL or fabric leak, ratio of left atrial (LA) to LAA linear attenuation coefficient, and DRT were analysed. One hundred and two patients underwent LAAC (79 WATCHMAN, 17 Amulet, 6 ACP). Mean age was 76.4±7.5 years, CHADS2 score 3.0±1.3, and CHADS-VASc score 4.6±1.6. CCTA was performed at a mean of 105.2±54.8 days, and TEE at a mean of 124.9±100.3 days post LAAC. LAA patency was observed in 52/100 (52%), with 45 (86.5%) via PDL and seven (13.5%) through fabric leak. Linear attenuation coefficient <100 HU and LA:LAA ratio <0.25 were seen in occluded devices. PDL was only observed in 35/102 (34.3%) on TEE. Mean device compression was greater with sealed devices (11.3±4.3% versus 8.2±4.0%, p<0.001). There was only one DRT, which was observed on both TEE and CCTA.
Conclusions
CCTA is a suitable alternative to TEE for device surveillance post LAAC. CCTA was more sensitive than TEE for assessing PDL and can delineate the cause of residual LAA contrast patency.



EuroIntervention: 19 Oct 2019; 15:663-670
Qamar SR, Jalal S, Nicolaou S, Tsang M, Gilhofer T, Saw J
EuroIntervention: 19 Oct 2019; 15:663-670 | PMID: 31217149
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Abstract

Pulmonary artery denervation using catheter-based ultrasonic energy.

Rothman A, Jonas M, Castel D, Tzafriri AR, ... Ben-Yehuda O, Rubin L
Aims
Pulmonary arterial hypertension is a devastating disease characterised by pulmonary vascular remodelling and right heart failure. Radio-frequency pulmonary artery denervation (PDN) has improved pulmonary haemodynamics in preclinical and early clinical studies; however, denervation depth is limited. High-frequency non-focused ultrasound can deliver energy to the vessel adventitia, sparing the intima and media. We therefore aimed to investigate the feasibility, safety and efficacy of ultrasound PDN.
Methods and results
Histological examination demonstrated that innervation of human pulmonary arteries is predominantly sympathetic (71%), with >40% of nerves at a depth of >4 mm. Finite element analysis of ultrasound energy distribution and ex vivo studies demonstrated generation of temperatures >47ºC to a depth of 10 mm. In domestic swine, PDN reduced mean pulmonary artery pressure induced by thromboxane A2 in comparison to sham. No adverse events were observed up to 95 days. Histological examination identified structural and immunohistological changes of nerves in PDN-treated animals, with sparing of the intima and media and reduced tyrosine hydroxylase staining 95 days post procedure, indicating persistent alteration of the structure of sympathetic nerves.
Conclusions
Ultrasound PDN is safe and effective in the preclinical setting, with energy delivery to a depth that would permit targeting sympathetic nerves in humans.



EuroIntervention: 19 Oct 2019; 15:722-730
Rothman A, Jonas M, Castel D, Tzafriri AR, ... Ben-Yehuda O, Rubin L
EuroIntervention: 19 Oct 2019; 15:722-730 | PMID: 31062694
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Abstract

Initial European experience with transcaval transcatheter aortic valve implantation.

Costa G, De Backer O, Pilgrim T, Kasel M, ... Greenbaum AB, Søndergaard L
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 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 proofs 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.



EuroIntervention: 28 Oct 2019; epub ahead of print
Costa G, De Backer O, Pilgrim T, Kasel M, ... Greenbaum AB, Søndergaard L
EuroIntervention: 28 Oct 2019; epub ahead of print | PMID: 31659987
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Abstract

Randomized Comparison of Bare Metal or Drug-Eluting Stent versus Drug Coated Balloon in Non-ST-Elevation Myocardial Infarction - PEPCAD NSTEMI.

Scheller B, Ohlow MA, Ewen S, Kische S, ... Brachmann J, Bärisch A

Two hundred and ten patients with Non-ST-Elevation Myocardial Infarction were randomized. Mean age was 67±12 years, 67% were male, 62% had multivessel disease, and 31% were diabetics. In the stent group, 56% of patients were treated with BMS, 44% with current generation DES. In the DCB group, 85% of patients were treated with DCB only whereas 15% underwent additional stent implantation. During a follow-up of 9.2 ± 0.7 months, DCB treatment was noninferior to stent treatment with a target lesion failure (TLF) of 3.8% vs 6.6% (intention-to-treat, p=0.53). Total MACE rate was 6.7% for DCB vs 14.2% for stent treatment (p=0.11), and 5.9% vs. 14.4% in the per protocol analysis (p=0.056), respectively.



EuroIntervention: 28 Oct 2019; epub ahead of print
Scheller B, Ohlow MA, Ewen S, Kische S, ... Brachmann J, Bärisch A
EuroIntervention: 28 Oct 2019; epub ahead of print | PMID: 31659986
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Impact:
Abstract

Performance of Current Risk Models in Predicting Short-Term Mortality After Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis.

Siddiqi TJ, Usman MS, Khan MS, Khan MAA, ... Desai MY, Bhatt DL
Aims
To evaluate the performance of risk stratification models (RSMs) in predicting short-term mortality after transcatheter aortic valve replacement (TAVR).
Methods and results
MEDLINE and Scopus were queried to identify studies which validated RSMs designed to assess 30-day or in-hospital mortality after TAVR. Discrimination and calibration were assessed using C-statistics and observed/expected ratios (OERs), respectively. C-statistics were pooled using a random-effects inverse-variance method, while OERs were pooled using the Peto odds ratio. A good RSM is defined as one with c-statistic >0.7 and OER close to 1.0. Twenty-four studies (n=68,215 patients) testing 11 different RSMs were identified. Discrimination of all RSMs was poor (C-statistic<0.7); however, certain TAVR-specific RSMs such as the in-hospital STS/ACC TVT (C-statistic=0.65) and STT (C-statistic=0.66) predicted individual mortality more reliably than surgical models (C-statistic range=0.59-0.61). A good calibration was demonstrated by the in-hospital STS/ACC TVT (OER=0.99), 30-day STS/ACC TVT (OER=1.08) and STS (OER=1.01) models. Baseline dialysis (OER: 2.64 [1.88, 3.70]; p<0.001) was the strongest predictor of mortality.
Conclusions
This study demonstrates that the STS/ACC TVT model (in-hospital and 30-day) and the STS model have accurate calibration, making them useful for comparison of center-level risk-adjusted mortality. In contrast, the discriminative ability of currently available models is limited.



EuroIntervention: 28 Oct 2019; epub ahead of print
Siddiqi TJ, Usman MS, Khan MS, Khan MAA, ... Desai MY, Bhatt DL
EuroIntervention: 28 Oct 2019; epub ahead of print | PMID: 31659984
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Abstract

Contemporary Outcomes of the Retrograde Approach to Chronic Total Occlusion Interventions: Insights from an International CTO Registry.

Tajti P, Xenogiannis I, Gargoulas F, Karmpaliotis D, ... Ungi I, Banerjee S
Aims
The retrograde approach is critical for achieving high success rates in chronic total occlusion (CTO) percutaneous coronary intervention (PCI), but has been associated with higher risk of complications.
Methods and results
We compared the technical and procedural outcomes of retrograde (n=1,515) and antegrade-only CTO PCIs (n=2,686) in a contemporary multicenter CTO registry. The mean age of patients undergoing retrograde PCI was 65±10 years and 86% were men, with high prevalence of prior myocardial infarction (51%), prior PCI (71%), and coronary artery bypass graft surgery (45%). The mean J-CTO (3±1 vs 2±1 p<0.001) was higher in retrograde PCIs. The most commonly used collateral channels were septals (65%), epicardials (32%), saphenous venous grafts (14%) and left internal mammary artery grafts (2%). Overall technical (79% vs 91%, p<0.001) and procedural (75% vs 90%, p<0.001) success rates were lower with the retrograde approach, and patients had higher in-hospital major complications rate than antegrade-only PCIs (5.1% vs 0.8%, p<0.001), due to higher mortality (1.1% vs. 0.1%, p<0.001), acute myocardial infarction (1.9% vs 0.2%, p<0.001), repeat-PCI (0.7% vs 0.1%, p=0.001), and pericardiocentesis (1.7% vs 0.3%, p<0.001).
Conclusions
In summary, retrograde approach to CTO PCI is performed in higher complexity lesions and is associated with lower success and higher major complications rates.



EuroIntervention: 21 Oct 2019; epub ahead of print
Tajti P, Xenogiannis I, Gargoulas F, Karmpaliotis D, ... Ungi I, Banerjee S
EuroIntervention: 21 Oct 2019; epub ahead of print | PMID: 31638578
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Abstract

The influence of multidirectional shear stress on plaque progression and composition changes in human coronary arteries.

Kok AM, Molony DS, Timmins LH, Ko YA, ... Wentzel JJ, Samady H
Aims
Local wall shear stress (WSS) plays an important role in the onset of atherosclerotic plaque formation; however, it does not fully explain plaque progression and destabilisation. We aimed to investigate for the first time the influence of multidirectional WSS features on plaque progression and plaque composition changes in human coronary arteries.
Methods and results
Coronary artery imaging using biplane angiography and virtual histology intravascular ultrasound (VH-IVUS) was performed in twenty patients with coronary artery disease at baseline and after six-month follow-up. Three-dimensional surfaces of the coronary arteries were generated using the coronary imaging and, together with patient-specific flow measurements, different WSS features (multidirectional and conventional time-averaged WSS [TAWSS]) were determined at baseline using computational fluid dynamics (CFD). The changes in plaque component area over the six-month period were determined from VH-IVUS. Changes in plaque composition rather than plaque size were primarily associated with the (multidirectional) WSS at baseline. Interestingly, regions simultaneously exposed to low TAWSS and low multidirectional WSS showed the greatest plaque progression (p<0.001).
Conclusions
In this patient study, several multidirectional WSS features were found to contribute significantly to coronary plaque progression and changes in plaque composition.



EuroIntervention: 19 Oct 2019; 15:692-699
Kok AM, Molony DS, Timmins LH, Ko YA, ... Wentzel JJ, Samady H
EuroIntervention: 19 Oct 2019; 15:692-699 | PMID: 30860071
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Abstract

Transcatheter aortic valve replacement outcomes in patients with sarcopaenia.

Heidari B, Al-Hijji MA, Moynagh MR, Takahashi N, ... Rihal CS, Lerman A
Aims
Sarcopaenia is a prevalent disease of ageing, associated with adverse clinical outcomes. We aimed to compare in-hospital adverse outcomes and overall mortality in sarcopaenic and non-sarcopaenic patients undergoing transcatheter aortic valve replacement (TAVR).
Methods and results
This was a retrospective cohort study including 602 patients who underwent TAVR. Sarcopaenia was defined as skeletal muscle mass index <55.4 cm2/m2 in males and <38.9 cm2/m2 in females obtained through pre-TAVR CT scan. Mortality, length of hospital stay, ICU admission, and Valve Academic Research Consortium (VARC)-2-defined post-TAVR complications were defined as outcomes. Study participants (mean age 80.9±8.9 years and 56.8% male) were followed for a median of 1.5 years. Two thirds of the TAVR population was sarcopaenic. In-hospital outcomes were similar in both groups; however, overall survival was worse in sarcopaenic patients (HR for mortality=1.46 [1.06-2.14], p=0.02). In a multivariable model, sarcopaenia, porcelain aorta, pre-TAVR atrial fibrillation/flutter, severe chronic kidney disease, chronic pulmonary disease, VARC-2 bleeding, acute renal failure following TAVR, and post-TAVR cardiac arrest were predictors of mortality.
Conclusions
Sarcopaenic patients had similar in-hospital clinical outcomes to non-sarcopaenic patients following TAVR which reveals TAVR safety in sarcopaenic patients. However, sarcopaenia was an independent risk factor for midterm mortality indicating its potential value in systematic evaluation of this highly comorbid population in order to decide the best treatment approaches.



EuroIntervention: 19 Oct 2019; 15:671-677
Heidari B, Al-Hijji MA, Moynagh MR, Takahashi N, ... Rihal CS, Lerman A
EuroIntervention: 19 Oct 2019; 15:671-677 | PMID: 31062696
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Abstract

Radial versus femoral approach for left ventricular endomyocardial biopsy.

Choudhury T, Lurz P, Schäufele TG, Menezes MN, ... Mamas MA, Bagur R
Aims
Despite the widespread use of the radial approach in coronary interventions, left ventricular endomyocardial biopsy (LV-EMB) is most frequently performed via the femoral artery. We sought to assess the feasibility and safety of radial compared to femoral access in a large cohort of patients undergoing LV-EMB.
Methods and results
Data from 264 patients who underwent LV-EMB in Germany, Portugal, Japan and Canada were collected. Clinical, procedural, safety and feasibility data were evaluated and compared between the two groups. LV-EMB was successfully performed by the radial approach in 129 (99%) of 130 and in 134 (100%) patients by the femoral access. Patients in the radial group were older (mean age 55.7 versus 44.3 years) and were more likely to have moderate-severe mitral regurgitation (27.7% versus TF 0%). Sheathless guides were used in 108 (83.1%) of the radial and 2 (1.5%) of the femoral patients, so the mean guiding catheter size (radial 7.0±1.0 Fr versus femoral 8.0±0.0 Fr) was significantly smaller in the radial group (p<0.001). Mild or moderate radial artery spasm occurred in 13 (10.0%) patients but only one (0.8%) patient required conversion to femoral access due to severe spasm. No access site-related complications were reported in the radial group, while 11 (8.2%) patients in the femoral group had access-site haematomas (p=0.001). There were no major complications (mitral valve injury, pericardial tamponade requiring intervention, cerebrovascular accidents, persistent high-degree atrioventricular block, major bleeding or death) in either group.
Conclusions
The radial approach for LV-EMB appears to be safe and associated with a high success rate while possibly leading to fewer access-site bleeding complications compared to the femoral access. The results of this international multicentre study support the radial approach for LV-EMB and further inspire the expansion of \"radial first\" in the field of interventional cardiology.



EuroIntervention: 19 Oct 2019; 15:678-684
Choudhury T, Lurz P, Schäufele TG, Menezes MN, ... Mamas MA, Bagur R
EuroIntervention: 19 Oct 2019; 15:678-684 | PMID: 30741639
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Impact:
Abstract

The Obesity Paradox Revisited: Body Mass Index and Long-Term Outcomes After PCI From a Large Pooled Patient-Level Database.

Wolny R, Maehara A, Liu Y, Zhang Z, ... Leon MB, Stone GW
Aims
To evaluate the relationship between body mass index (BMI) and outcomes in patients with coronary artery disease undergoing percutaneous revascularization.
Methods and results
In 13 randomized trials 22,922 patients were stratified (in kg/m2) as underweight (BMI <18.5), normal weight (18.5≤BMI<25, used as reference), overweight (25≤BMI<30), and obese (Class I [30≤BMI<35], Class II [35≤BMI<40], or Class III [BMI≥40]). The primary endpoint was all-cause death at 5 years. Secondary endpoints were cardiac and non-cardiac death, target (TLR) and non-target lesion revascularization (NTLR), myocardial infarction (MI), and definite/probable stent thrombosis. Despite adjustment for multiple confounders, overweight and Class I obesity were associated with lower all-cause mortality vs normal weight (HR 0.83; 95%CI 0.71-0.96 and HR 0.83; 95%CI 0.69-0.96 respectively); however, non-cardiac death was the major contributor to this effect (HR 0.77; 95% CI 0.63-0.94 for overweight). Conversely, cardiac mortality was higher in severely obese individuals (HR 1.62; 95%CI 1.05-2.51 for Class III obesity). Obesity was associated with higher rates of NTLR (HR 1.28, 95%CI 1.04-1.58 for Class II obesity) but not with TLR, MI and stent thrombosis.
Conclusions
Moderately increased BMI is associated with improved survival post-PCI, mostly due to lower non-cardiac but not cardiac mortality.



EuroIntervention: 28 Oct 2019; epub ahead of print
Wolny R, Maehara A, Liu Y, Zhang Z, ... Leon MB, Stone GW
EuroIntervention: 28 Oct 2019; epub ahead of print | PMID: 31659983
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Impact:
Abstract

Impact of abrupt versus gradual correction of mitral and tricuspid regurgitation: a modelling study.

Walmsley J, Squara P, Wolfhard U, Cornelussen R, Lumens J
Aims
Correction of mitral and/or tricuspid regurgitation (MR, TR) frequently leads to poor outcomes in the days following intervention. We sought to understand how abrupt correction of MR and TR affects ventricular load and to investigate if gradual correction is beneficial.
Methods and results
MR and TR were simulated using the CircAdapt cardiovascular system model with effective regurgitant orifice (ERO) areas of 0.5 cm2 and 0.7 cm2. Ventricular and atrial contractility reductions to 40% of normal and pulmonary hypertension were simulated. Abrupt and gradual ERO closure were simulated with homeostatic regulation of blood pressure and volume. Abrupt correction of MR increased left and right ventricular fibre stress by 40% and 15%, respectively, whereas TR correction increased left and right ventricular fibre stress by 26% and 19%, respectively. This spike was followed by a rapid drop in fibre stress. Myocardial dysfunction prolonged the spike but reduced its amplitude. Right ventricular fibre stress increased more with pulmonary hypertension and TR. Gradual correction demonstrated no spike in tissue load.
Conclusions
Simulations demonstrated that abrupt ERO closure creates a transient increase in ventricular load that is prolonged by worsened myocardial condition and exacerbated by pulmonary hypertension. Gradual closure of the ERO abolishes this spike and merits clinical investigation.



EuroIntervention: 19 Nov 2019; 15:902-911
Walmsley J, Squara P, Wolfhard U, Cornelussen R, Lumens J
EuroIntervention: 19 Nov 2019; 15:902-911 | PMID: 31746755
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Abstract

Impact of implant depth on hydrodynamic function with the ALLEGRA transcatheter heart valve following valve-in-valve intervention.

Sathananthan J, Fraser R, Kütting M, Hensey M, ... Wood D, Webb JG
Aims
We assessed the impact of implant depth on hydrodynamic function following valve-in-valve (VIV) intervention using the ALLEGRA (New Valve Technology, Hechingen, Germany) transcatheter heart valve (THV) in three different surgical valve designs.
Methods and results
Multiple implantation depths (+2mm, -2mm and -6mm) were tested using a 23mm ALLEGRA THV for VIV intervention in 19mm, 21mm, 23mm, and 25mm Epic, Mitroflow and Magna Ease bioprosthetic valves. Multimodality imaging and hydrodynamic evaluation was performed at each implantation depth. The 23mm ALLEGRA valve had gradients <20mmHg in the Mitroflow and Epic valves sized ³21mm, and in all sizes of the Magna Ease valve. Gradients did not increase significantly at lower implantation depths. The 19mm Epic (+2mm: 20.1±0.6mmHg, -2mm: 18.8±0.5mmHg, -6mm: 22.8±0.3mmHg) and 19mm Mitroflow (+2mm: 24.1±0.2mmHg, -2mm: 31.5±0.3mmHg, -6mm: 25.6±0.2mmHg) valves, had elevated mean gradients. In larger sized surgical valves (³23mm) the regurgitant fraction was higher at low implantation depths. Pinwheeling was significantly worse in the smaller sized (£21mm) surgical valves and also at low (<-2mm) implantation depth.
Conclusions
The 23mm ALLEGRA valve had favourable (<20mmHg) gradients in all surgical valves sized ³21mm, even when the THV was implanted low. In 19mm sized Mitroflow and Epic valves, gradients were elevated (>20mmHg). While there was no major difference in mean transvalvular gradients, leaflet pinwheeling was worse at lower implantation depths.



EuroIntervention: 14 Oct 2019; epub ahead of print
Sathananthan J, Fraser R, Kütting M, Hensey M, ... Wood D, Webb JG
EuroIntervention: 14 Oct 2019; epub ahead of print | PMID: 31607682
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Abstract

Intravascular lithotripsy for calcific coronary and peripheral artery stenoses.

Dini CS, Tomberli B, Mattesini A, Ristalli F, ... Ali ZA, Di Mario C

Heavily calcified lesions may be difficult to dilate adequately with conventional balloons and stents, which causes frequent periprocedural complications and higher rates of target lesion revascularisation (TLR). High-pressure non-compliant balloon angioplasty may be of insufficient force to modify calcium and, even when successful, may be limited in its ability to modify the entire calcified lesion. Scoring and cutting balloons hold theoretical value but data to support their efficacy are lacking and, because of their high lesion crossing profile, they often fail to reach the target lesion. Rotational and orbital atherectomy target superficial calcium; however, deep calcium, which may still impact on vessel expansion and luminal gain, is not affected. Intravascular lithotripsy (IVL), based on lithotripsy for renal calculi, is a new technology which uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue. Energy is delivered via a balloon catheter, analogous to contemporary balloon catheters, with transmission through diluted ionic contrast in a semi-compliant balloon inflated at low pressure with sufficient diameter to achieve contact with the vessel wall. With coronary and peripheral balloons approved in Europe, peripheral balloons approved in the USA and multiple new trials beginning, we review the indications for these recently introduced devices, summarise the clinical outcomes of the available trials and describe the design of ongoing studies.



EuroIntervention: 19 Oct 2019; 15:714-721
Dini CS, Tomberli B, Mattesini A, Ristalli F, ... Ali ZA, Di Mario C
EuroIntervention: 19 Oct 2019; 15:714-721 | PMID: 31062700
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Abstract

Personalised fractional flow reserve: a novel concept to optimise myocardial revascularisation.

Gosling RC, Morris PD, Lawford PV, Hose DR, Gunn JP
Aims
Fractional flow reserve (FFR) represents the percentage reduction in coronary flow relative to a hypothetically normal artery; however, percutaneous coronary intervention (PCI) seldom achieves physiological normality (FFR 1.00), particularly in the context of diffuse disease. In this study we describe a method for calculating the vessel-specific maximal achievable FFR (FFRmax) providing a personalised assessment of what PCI can achieve.
Methods and results
FFR measurements were obtained from 71 patients (100 arteries) undergoing angiography. Three-dimensional (3D) coronary anatomy was reconstructed from angiographic images. An ideal intervention, in which all stenoses are removed, was modelled, and the FFRmax calculated. The \"personalised\" FFR (FFRpers) was calculated as measured FFR/FFRmax. PCI was performed in 52 vessels and post-PCI FFR measured in 50. FFRmax was compared to post-PCI measured FFRs. The mean FFRmax was 0.92 (±0.04). This was on average 0.04 (±0.05) higher than the corresponding post-PCI measured FFR (p<0.001). FFRpers was significantly higher (0.06±0.04) than measured FFR (p<0.001), indicating that FFR overestimates flow restoration achievable with PCI.
Conclusions
A patient\'s maximal achievable FFR can now be determined prior to PCI. This approach provides a more realistic assessment of the physiological benefit of PCI than is implied by baseline FFR and may prevent unnecessary intervention.



EuroIntervention: 19 Oct 2019; 15:707-713
Gosling RC, Morris PD, Lawford PV, Hose DR, Gunn JP
EuroIntervention: 19 Oct 2019; 15:707-713 | PMID: 30561366
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Abstract

Enhanced platelet inhibition by clopidogrel and risk of bleeding in patients requiring oral anticoagulation after drug-eluting stent implantation.

Goedel A, Fiedler KA, Mehilli J, Bernlochner I, ... Kastrati A, Sarafoff N
Aims
Clopidogrel is the P2Y12 inhibitor of choice in patients who undergo PCI and have an indication for oral anticoagulation (OAC). Prediction of the bleeding risk is of major interest in this population. The aim of this analysis was to investigate whether an enhanced platelet inhibition by clopidogrel measured by platelet function testing (PFT) with the Multiplate Analyzer is associated with an increased bleeding risk in patients on triple antithrombotic therapy.
Methods and results
This investigation was performed in a cohort of 524 patients from the randomised ISAR-TRIPLE trial; 458 (87.4%) had PFT results available in the first 24 hours after PCI. Patients belonging to the lowest quintile according to PFT were considered as enhanced responders to clopidogrel. The primary endpoint was major bleeding according to TIMI criteria at nine months. The median of ADP-induced platelet aggregation in the whole population was 163 AU*min (107-241). Patients in the lowest quintile had values below 93 AU*min. These enhanced responders (92 patients) had a significantly higher risk of TIMI major bleeding (hazard ratio [HR] 3.13, 95% confidence interval [CI]: 1.38-7.09, p=0.01) and overall mortality (HR 3.42, 95% CI: 1.55-7.52, p=0.004) compared with the remaining patients (366 patients). No significant difference was observed for the secondary combined ischaemic endpoint (HR 1.27, 95% CI: 0.47-3.47, p=0.64).
Conclusions
Enhanced platelet inhibition delivered by clopidogrel is associated with an increased risk for major bleeding and death in patients on OAC who undergo PCI. These results support the use of PFT to identify patients with an increased risk for bleeding.



EuroIntervention: 19 Oct 2019; 15:700-706
Goedel A, Fiedler KA, Mehilli J, Bernlochner I, ... Kastrati A, Sarafoff N
EuroIntervention: 19 Oct 2019; 15:700-706 | PMID: 30834895
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Impact:
Abstract

Quantitative Flow Ratio guided Residual Functional SYNTAX Score for Risk Assessment in Patients with ST-Segment Elevation Myocardial Infarction undergoing Percutaneous Coronary Intervention.

Tang J, Lai Y, Tu S, Chen F, ... Yang C, Liu X
Aims
This study was aimed at investigating the prognostic ability of quantitative flow ratio (QFR) guided residual functional SYNTAX score (Q-rFSS) and functional incomplete revascularization (IR) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).
Methods and results
A total of consecutive 354 STEMI patients was included. Q-rFSS was defined as residual SYNTAX score (rSS) measured in vessels with QFR ≤0.8. At 2-year follow-up, functional IR (Q-rFSS≥1) showed significantly higher risk for major adverse cardiac events (MACE) than functional complete revascularization (CR) (Q-rFSS=0) (functional IR vs. CR, 22.0% vs. 7.4%; hazard ratio: 3.21; 95% confidence interval (Cl): 1.74 to 5.91; p<0.001). The area under curve (AUC) of Q-rFSS (0.738, 95% CI: 0.659 to 0.817) was significantly greater than that of rSS (0.648, 95% CI: 0.547 to 0.749). C-statistic for MACE increased from 0.656 (0.582 to 0.729) to 0.767 (0.705 to 0.829) after the addition of Q-rFSS to the clinical risk factors. Q-rFSS significantly improved risk classification compared with rSS (net reclassification improvement 0.439, 95% CI: 0.201 to 0.548; p<0.001).
Conclusions
Functional IR is associated with higher risk of MACE during long-term follow-up in STEMI patients undergoing PCI. Q-rFSS has a better prognostic ability for the risk of MACE.



EuroIntervention: 07 Oct 2019; epub ahead of print
Tang J, Lai Y, Tu S, Chen F, ... Yang C, Liu X
EuroIntervention: 07 Oct 2019; epub ahead of print | PMID: 31589145
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Impact:
Abstract

Impact of the one-year angioscopic findings on long-term clinical events in 504 patients treated with first-generation or second-generation drug-eluting stents: the DESNOTE-X study.

Sotomi Y, Suzuki S, Kobayashi T, Hamanaka Y, ... Sakata Y, Higuchi Y
Aims
We aimed to test the hypothesis that the presence of in-stent yellow plaque (YP) assessed by angioscopy would be a risk of very late stent failure (VLSF) of the cobalt-chromium everolimus-eluting stent (CoCr-EES) in comparison with first-generation drug-eluting stents (DES).
Methods and results
DESNOTE-X was a prospective cohort study, an extended study of the DESNOTE study (UMIN000013515). All patients who received successful angioscopic examination at planned one-year follow-up of DES were clinically followed. The primary endpoint was VLSF defined as a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularisation. A total of 504 patients with 549 lesions were enrolled over a period of 12.5 years. At one-year follow-up, the incidence of YP was significantly higher in the first-generation DES than in the CoCr-EES (199/292 [68%] vs 80/257 [31%], p<0.001). Maximum yellow colour grade on coronary angioscopy at one-year follow-up was an independent predictor of future VLSF in the first-generation DES (HR 2.604 [95% CI: 1.265-5.361], p=0.009), whereas it was not in the CoCr-EES (p for interaction 0.022).
Conclusions
The incidence of in-stent atherosclerosis identified as YP on angioscopy was lower and its impact on late clinical events appeared smaller in the CoCr-EES than in the first-generation DES.



EuroIntervention: 19 Sep 2019; 15:631-639
Sotomi Y, Suzuki S, Kobayashi T, Hamanaka Y, ... Sakata Y, Higuchi Y
EuroIntervention: 19 Sep 2019; 15:631-639 | PMID: 30398964
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Impact:
Abstract

Impact of horizontal aorta on procedural and clinical outcomes in second-generation transcatheter aortic valve implantation.

Di Stefano D, Colombo A, Mangieri A, Gallone G, ... Montorfano M, Giannini F
Aims
The aim of this study was to evaluate the impact of a horizontal aorta (HA) on device success and short-term clinical outcomes of transcatheter aortic valve implantation (TAVI).
Methods and results
We retrospectively assessed 547 consecutive patients treated with transfemoral second-generation non-balloon-expandable (NBE) (n=447) and balloon-expandable (BE) (n=100) TAVI for symptomatic severe aortic stenosis. Aortic angulation (AA) was evaluated with preprocedural computed tomography. Patients were dichotomised according to a previously established AA cut-point: HA group (AA ≥48°, n=230) and normal aorta (NA) group (AA <48°, n=317). Endpoints were considered according to the Valve Academic Research Consortium-2 definitions. Fluoroscopy time (32.8±16.4 vs 30.3±13.9 minutes, p=0.060) and radiation dose (kerma area product 120.8±99.7 vs 103.7±81.1 Gy·cm2, p=0.033) were higher in the HA group as compared to the NA group. No difference in device success was observed between patients with and without an HA (88.3% vs 88.0%, p=0.929). No differences in device success and 30-day outcomes were observed when comparing HA and NA patients, according to BE and NBE prostheses.
Conclusions
The presence of an HA has no impact on device success and short-term clinical outcomes of TAVI with either second-generation NBE or BE devices.



EuroIntervention: 03 Oct 2019; 15:e749-e756
Di Stefano D, Colombo A, Mangieri A, Gallone G, ... Montorfano M, Giannini F
EuroIntervention: 03 Oct 2019; 15:e749-e756 | PMID: 31334701
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Impact:
Abstract

Prediction of side branch occlusions in percutaneous coronary interventions by coronary computed tomography: the CT bifurcation score as a novel tool for predicting intraprocedural side branch occlusion.

Lee SH, Lee JM, Song YB, Park TK, ... Choe YH, Choi JH
Aims
Side branch (SB) occlusion is one of the major technical hurdles in the percutaneous coronary intervention (PCI) of bifurcation lesions. Our aim was to investigate whether preprocedural coronary computed tomography angiography (CCTA) could predict intraprocedural SB occlusion.
Methods and results
A total of 260 bifurcation lesions were enrolled from 246 patients who underwent CCTA before elective bifurcation PCI. Quantitative plaque analysis was performed in the main vessel (MV) and SB. Intraprocedural SB occlusion occurred in 42 lesions (16%). These lesions were characterised by SB plaque, calcified plaque in the MV, low attenuation plaque in the main proximal segment or SB, and a ratio of MV to SB ostium area >4.3, which constituted a point-based CT bifurcation score. The CT bifurcation score was cross-validated, outperforming any angiographic Medina classification or RESOLVE score (c-statistics=0.749 versus 0.631 to 0.551; p<0.05 for all). The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the CT bifurcation score ≥1 were 90%, 42%, 23%, 96%, and 50%, respectively.
Conclusions
Comprehensive CCTA assessment was able to predict intraprocedural SB occlusion better than the current angiographic classification or scoring system. The CT bifurcation score may thus be a helpful guide for selecting the optimal bifurcation PCI strategy.



EuroIntervention: 03 Oct 2019; 15:e788-e795
Lee SH, Lee JM, Song YB, Park TK, ... Choe YH, Choi JH
EuroIntervention: 03 Oct 2019; 15:e788-e795 | PMID: 30636682
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Impact:
Abstract

A novel method to quantitate bioprosthetic valve leaflet mechanical stress: a numerical and in vitro study.

Stanová V, Godio Raboutet Y, Masson C, Py M, ... Rieu R, Pibarot P

An original in vitro/in silico method was developed to estimate the local and global mechanical stress applied on the bioprosthetic valve leaflet, which can be important for better understanding of the valve durability. A non-contact system based on stereophotogammetry and digital image correlation enabled filming and studying the valve leaflet movement frame by frame and performing three-dimensional analysis. The deformation was applied in a finite element model in order to calculate the local mechanical stress applied. High stress regions were primarily observed in the upper leaflet edge and belly and to a lesser extent at the free leaflet edge.



EuroIntervention: 19 Sep 2019; 15:581-585
Stanová V, Godio Raboutet Y, Masson C, Py M, ... Rieu R, Pibarot P
EuroIntervention: 19 Sep 2019; 15:581-585 | PMID: 31130522
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Impact:
Abstract

Sex-Specific Differences in Coronary Blood Flow and Flow Velocity Reserve in Symptomatic Patients with Non-obstructive Disease.

Corban MT, Prasad A, Gulati R, Lerman LO, Lerman A
Aims
Reduced coronary flow velocity reserve (CFVR) is associated with adverse cardiovascular outcomes. Whether CFVR and coronary blood flow (CBF) are similar in men and women with chest pain and non-obstructive CAD remains unknown. We hypothesized sex-differences in CFVR and CBF.
Methods and results
1683 patients with signs/symptoms of ischemia and angiographically unobstructed coronary arteries (<40% angiographic stenosis) underwent coronary vasomotion evaluation. CFVR was measured as hyperemic/resting average velocity in the LAD. Mid-LAD diameter was measured with quantitative angiography and CBF calculated at rest (rCBF) and hyperemia (hCBF). Resting microvascular resistance (rMR) was calculated as mean arterial pressure/rCBF. 1096 (65%) were women, median age 51 (42, 59) years. Compared to men, women had lower median CFVR [2.7 (2.4, 3.2) vs. 3.1 (2.7, 3.6), p<0.001], higher rCBF [49.7 (34.0, 71.1) vs. 45.9 (31.8, 68.7) ml/min, p=0.04], lower hCBF [139.5 (93.0, 195.2) vs. 147.1 (95.7, 218.6) ml/min, p=0.02], but similar rMR (p=0.82). Female sex was independent predictor of lower CFVR, higher rCBF, and lower hCBF.
Conclusions
Compared to men, women with signs/symptoms of ischemia and non-obstructive CAD have lower CFVR, higher rCBF, and lower hCBF. Female sex is predictor of these sex-specific differences. The clinical diagnostic and prognostic implications of sex-differences in coronary physiology need further evaluation.



EuroIntervention: 07 Oct 2019; epub ahead of print
Corban MT, Prasad A, Gulati R, Lerman LO, Lerman A
EuroIntervention: 07 Oct 2019; epub ahead of print | PMID: 31589144
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Impact:
Abstract

Hemodynamic structural valve deterioration following transcatheter aortic valve implantation with latest-generation balloon-expandable valves.

Rheude T, Pellegrini C, Cassese S, Wiebe J, ... Husser O, Joner M
Aims
Elevated gradients have been proposed to be associated with hemodynamic structural valve deterioration (SVD) after transcatheter aortic valve implantation (TAVI) and data regarding their characterization remain scarce.
Methods and results
691 patients undergoing transfemoral TAVI were enrolled. The primary endpoint was moderate or severe hemodynamic SVD during 12-month follow-up after TAVI, defined as (I) mean transvalvular gradient ≥20 mmHg or (II) mean transvalvular gradient change ≥10 mmHg. The primary endpoint was observed in 10.3% after TAVI. Use of 20mm valve, valve-in-valve procedure and oral anticoagulation (OAC) were independently associated with hemodynamic SVD, whereas valve-in-valve procedure and OAC were the only significant variables after accounting for death as a competing event. OAC was significantly associated with both, hemodynamic SVD (RR 8.65; p=0.004) and death (RR 3.57; p=0.06), whereas valve-in-valve procedure was only associated with hemodynamic SVD (RR 52.76; p<0.001). Valve thrombosis was present in 0.87% (6/691) of all patients.
Conclusions
The prevalence of moderate or greater hemodynamic SVD during the first 12 months after TAVI is 10.3%. Procedural factors and pharmacotherapy seem to play a key role during manifestation. Future studies should focus on the underlying mechanisms.



EuroIntervention: 09 Sep 2019; epub ahead of print
Rheude T, Pellegrini C, Cassese S, Wiebe J, ... Husser O, Joner M
EuroIntervention: 09 Sep 2019; epub ahead of print | PMID: 31498111
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Impact:
Abstract

Prognostic value of post-intervention fractional flow reserve after intravascular ultrasound-guided second-generation drug-eluting coronary stenting.

Hoshino M, Kanaji Y, Hamaya R, Kanno Y, ... Yonetsu T, Kakuta T
Aims
The aim of this study was to investigate the prognostic value of fractional flow reserve (FFR) and a novel index (the D-index) of residual diffuse disease after intravascular ultrasound (IVUS)-guided second-generation drug-eluting stent (DES) implantation.
Methods and results
We evaluated 201 patients (201 lesions) who underwent IVUS-guided second-generation DES implantation in the left anterior descending artery with pre- and post-intervention physiological evaluations. Post-intervention hyperaemic pullback pressure recording was used to quantify residual diffuse disease using the novel D-index, defined as the difference between the distal stent and the far distal FFR values divided by distance. Clinical outcomes were assessed by vessel-oriented composite endpoints (VOCE) and major adverse cardiac events (MACE). The incremental discriminant and reclassification abilities of far distal FFR or D-index for VOCE and MACE were compared. Post intervention, far distal FFR and D-indices were significantly lower in vessels with VOCE. The optimal far distal FFR and D-index cut-off values for VOCE and MACE were 0.86 and 0.017 cm, respectively. Although both indices remained significant predictors of VOCE, only the D-index proved to be a significant predictor of MACE and significantly improved the incremental reclassification ability for MACE.
Conclusions
Residual diffuse disease assessed by the D-index after IVUS-guided second-generation DES implantation can help to predict both VOCE and MACE, while far distal FFR can help to predict VOCE specifically.



EuroIntervention: 03 Oct 2019; 15:e779-e787
Hoshino M, Kanaji Y, Hamaya R, Kanno Y, ... Yonetsu T, Kakuta T
EuroIntervention: 03 Oct 2019; 15:e779-e787 | PMID: 31012854
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Impact:
Abstract

Prognostic impact of the SYNTAX score II in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: analysis of a four-year all-comers registry.

Cid Alvarez AB, Gomez-Peña F, Redondo-Dieguez A, Avila A, ... González-Juanatey JR, Trillo-Nouche R
Aims
This study aimed to investigate the prognostic impact of the SYNTAX score II (SS-II) on ST-segment elevation myocardial infarction (STEMI) patients undergoing a primary percutaneous coronary intervention (pPCI).
Methods and results
This retrospective cohort study included 1,689 patients with STEMI who underwent pPCI between January 2008 and December 2016. The patients were categorised into three groups based on SS-II tertiles (SS-II low tertile <24 [n=585], SS-II intermediate tertile ≥24 and ≤34 [n=567], and SS-II high tertile >34 [n=537]). In-hospital mortality was significantly lower in patients with low and mid SS-II when compared with high SS-II (0.7% vs 0.5% vs 16.4%, p=0.001). During follow-up (median 2.35 years), a high SS-II was positively correlated with MACE (12.3% for low SS-II vs 18.3% for mid SS-II vs 43.2% for high SS-II, p=0.001), all-cause mortality (1.5% vs 3.9% vs 14.2%, p=0.001) and heart failure (0.3% vs 2.7% vs 8.2%, p=0.001). The SS-II showed additive value on top of GRACE, anatomical SYNTAX score and residual SYNTAX score.
Conclusions
The SS-II in patients with STEMI undergoing pPCI adds important prognostic information regarding midterm adverse outcomes, being an independent and powerful predictor of MACE, heart failure and all-cause mortality during follow-up.



EuroIntervention: 03 Oct 2019; 15:e796-e803
Cid Alvarez AB, Gomez-Peña F, Redondo-Dieguez A, Avila A, ... González-Juanatey JR, Trillo-Nouche R
EuroIntervention: 03 Oct 2019; 15:e796-e803 | PMID: 30175963
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Impact:
Abstract

Characteristics and significance of healed plaques in patients with acute coronary syndrome and stable angina: an in vivo OCT and IVUS study.

Wang C, Hu S, Wu J, Yu H, ... Jia H, Yu B
Aims
The aim of this study was to determine the prevalence and significance of plaque with a multilayered (ML) pattern in patients with acute coronary syndrome (ACS) versus stable angina pectoris (SAP) using OCT.
Methods and results
Two hundred and four patients (144 ACS and 60 SAP) with OCT imaging of the culprit lesions before intervention were studied. ML plaques were identified by OCT as plaque with multiple layers of distinct optical signals. ML plaque was identified in 119 out of 204 (58.3%) patients. ML plaques were more frequently observed in SAP than ACS (75% vs 51.4%, p=0.001). Patients with prior myocardial infarction (MI) had a higher incidence of ML plaque compared with those without (74.4% vs 54.5%, p=0.024). ML plaque had a higher degree of luminal stenosis (p=0.006), longer lesion length (p=0.025), more complex lesion type (B2/C) (p<0.001) on angiography and non-significant larger plaque burden (p=0.07) on IVUS compared with those without an ML pattern.
Conclusions
ML plaques, indicative of prior thrombosis, were frequently identified in patients with CAD, particularly more so in SAP and those with prior MI compared with ACS. The presence of an ML pattern is a marker of a greater extent and severity of CAD, suggesting a pathogenic link between plaque healing and lesion progression.



EuroIntervention: 03 Oct 2019; 15:e771-e778
Wang C, Hu S, Wu J, Yu H, ... Jia H, Yu B
EuroIntervention: 03 Oct 2019; 15:e771-e778 | PMID: 30946013
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Impact:
Abstract

Bare-metal stenting in (recurrent) coarctation of the aorta in children below 12 kg: initial results and mid-term follow-up.

van Kalsbeek RJ, Krings GJ, Molenschot MMC, Breur JMPJ
Aims
To report our experience with the Cook Formula® stent in the treatment of (recurrent) coarctation of the aorta in children below 12 kg.
Methods and results
In vitro study of the Cook Formula 418 (8 mm) and 535 (8 and 10 mm) stents demonstrated successful downcrimping on smaller balloons and predictable fracturing patterns. Between November 2012 and January 2019, one patient with native, one patient with post-interventional and thirteen patients with post-surgical coarctation of the aorta underwent implantation of a Cook Formula stent. Patient and procedural characteristics were obtained as well as procedural success, complications and follow-up. Median age was 4.3 months and median weight 5.5 kg. Arterial sheath size ranged from 5 to 7 Fr. In-stent diameters of 3.7 to 8.8 mm were obtained with a median residual gradient of 0 mm Hg. Major complications consisted of peri-procedural hemodynamic instability (n=1), dissection of the iliac artery (n=1) and non-deployment with surgical removal (n=1). Redilations were performed after a median interval of 24.3 months. Median follow-up was 31.7 months.
Conclusions
The bare-metal Cook Formula stent® provides a durable and effective alternative to reoperation and balloon dilatation for native as well as post-surgical aortic coarctation in children below 12 kg.



EuroIntervention: 30 Sep 2019; epub ahead of print
van Kalsbeek RJ, Krings GJ, Molenschot MMC, Breur JMPJ
EuroIntervention: 30 Sep 2019; epub ahead of print | PMID: 31566574
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Impact:
Abstract

Clinical impact of elevated tricuspid valve inflow gradients after transcatheter edge-to-edge tricuspid valve repair.

Orban M, Orban MW, Braun D, Deseive S, ... Nabauer M, Hausleiter J
Aims
The aim of this study was to compare outcome of patients with a post-procedural tricuspid valve gradient (TVG) of >3 mmHg vs. ≤3 mmHg after transcatheter edge-to-edge tricuspid valve repair (TTVR).
Methods and results
Between March 2016 and October 2018 we treated 145 patients with severe tricuspid regurgitation (TR) with TTVR by placing 2.2±0.7 clips per patient. Device success (TR reduction ≥1° to at least moderate) was achieved in 125 patients (86.2%). TTVR resulted in an elevated TVG >3 mmHg in 25 (17.2%) patients. Device success (84% vs. 86.7%, p=0.9), number of clips implanted (2.3±0.7 vs. 2.2±0.7, p=0.33), clinical improvement including NYHA class (III/IV 24% vs. 28%, p=0.92) and increase in 6 minute walking test at 1 month (67 m [IQR 5-103 m] vs. 56 m [IQR 8-97 m], p=0.93), mortality (HR 1.07; 95% CI [0.43-2.65], plogrank=0.88) and the combined endpoint mortality and hospitalization for heart failure at one year (HR 1.07; 95% CI [0.46-2.48], plogrank=0.88) was similar between patients with a TVG >3 mmHg vs. patients with a TVG ≤3mmHg.
Conclusions
A small cohort of patients demonstrated with an elevated TVG higher than 3 mmHg at discharge. This elevation had no impact on clinical improvement, on mortality and hospitalization for heart failure.



EuroIntervention: 09 Sep 2019; epub ahead of print
Orban M, Orban MW, Braun D, Deseive S, ... Nabauer M, Hausleiter J
EuroIntervention: 09 Sep 2019; epub ahead of print | PMID: 31498114
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Impact:
Abstract

Impact of Ticagrelor Monotherapy on Two-Year Clinical Outcomes in Patients with Long Stenting: A Post Hoc Analysis of the Global Leaders Trial.

Takahashi K, Chichareon P, Modolo R, Kogame N, ... Windecker S, Serruys PW
Aims
To evaluate the impact of a novel antiplatelet regimen in patients with increasing total stent length (TSL).
Methods and results
This is a post-hoc analysis of the Global Leaders trial, a prospective, multi-centre, open-label, randomised trial, investigating the impact of the experimental strategy (one-month dual antiplatelet regimen [DAPT] followed by 23-month ticagrelor monotherapy) versus the reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) in patients with Biolimus A9-eluting stent (BES). The primary endpoint was the composite of the all-cause death and new Q-wave myocardial infarction (MI), and the secondary endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at two years. To investigate the association between total stent length and outcomes, groups were compared in quartiles according to TSL, and the fourth quartile group was at significantly higher ischemic risk at two years. In that stratum (TSL≥ 46mm), the experimental strategy significantly reduced the risk of the primary endpoint (hazard ratio [HR]:0.67; 95% confidence interval [CI]:0.49-0.90; Pinteraction=0.043), while demonstrating a similar risk of BARC type 3 or 5 bleeding (HR:0.99; 95% CI:0.66-1.49; Pinteraction =0.975).
Conclusions
Ticagrelor monotherapy potentially could balance ischemic and bleeding risks, thereby achieving a net clinical benefit in patients with TSL≥ 46 mm with BES.



EuroIntervention: 09 Sep 2019; epub ahead of print
Takahashi K, Chichareon P, Modolo R, Kogame N, ... Windecker S, Serruys PW
EuroIntervention: 09 Sep 2019; epub ahead of print | PMID: 31498113
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Impact:
Abstract

Thirty-day outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study.

Schäfer U, Butter C, Landt M, Frerker C, ... Charitos E, Conradi L
Aims
The VIVALL study aims to investigate the technical feasibility, safety and performance of the ALLEGRA transcatheter heart valve (THV) for the treatment of failing surgical aortic valves (SAV).
Methods and results
Thirty patients with failing SAV were investigated. An independent combined Data Safety Monitoring-Clinical Events Committee (DSM-CEC) and core lab adjudicated adverse events, patient safety and echocardiograms, respectively. Primary endpoints were invasive post-procedure mean pressure gradient (performance) and 30-day survival (safety). Of the treated patients (78.6±6.0 years, 50% female, STS score 4.5±2.1% and EuroSCORE II 9.2±4.3%), the majority (90%) had a small SAV (true inner diameter ≤22 mm). Implantation was successful in all but one patient (96.7%). Overall, the invasively assessed preoperative mean pressure gradient was significantly reduced from 37.1±13.3 mmHg to 11.6±3.7 mmHg. At 30 days, all-cause mortality and new pacemaker implantation were both 0% and the effective orifice area increased from 1.18±0.58 cm2 at baseline to 1.4±0.52 cm2. Paravalvular regurgitation was \"none or trace\" in 100% of the cases.
Conclusions
Transfemoral implantation of the ALLEGRA THV is feasible and safe in patients with failing SAV. Haemodynamic outcomes and a 100% survival rate after 30 days suggest that the ALLEGRA THV might be a valid option for valve-in-valve treatment.



EuroIntervention: 03 Oct 2019; 15:e757-e763
Schäfer U, Butter C, Landt M, Frerker C, ... Charitos E, Conradi L
EuroIntervention: 03 Oct 2019; 15:e757-e763 | PMID: 31355750
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Impact:
Abstract

Meta-Analysis of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in patients at Low Surgical Risk.

Witberg G, Landes U, Lador A, Yahav D, Kornowski R
Aims
Although transcatheter aortic valve replacement (TAVI) is officially indicated for severe aortic stenosis (AS) patients at intermediate or higher surgical risk, the procedure is increasingly being performed in patients who are at low surgical risk as well, data on the benefit of TAVI in this patient population is limited.
Methods and results
We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies with propensity score matching (PSM) of TAVI vs. surgical aortic valve replacement (SAVR) in patients who are at low surgical risk (mean STS score <4% and/or logistic EuroScore <10%). The primary outcome was mortality (examined at 30 days, year and longest available follow up). The secondary outcomes included procedural complications. Nine studies (n=6,124) were included. TAVI was associated with a numerically, but not statistically significant reduced mortality at 30 days (1.45 vs. 2.1%, p=0.05), and similar mortality at 1 year (5.1% vs. 5.0%, p=0.74),and a median of 2 years (10.8% vs. 9.8%, p=0.15). For both time points, there was significant heterogeneity between RCT/PSM studies, with the former suggesting survival advantage for TAVI and the latter for SAVR. In terms of periprocedural complications, TAVI was associated with reduced risk for stroke, bleeding and renal failure and an increase in vascular complications and Pacemaker implantation.
Conclusions
in patients who are at low surgical risk, TAVI seems to be associated with equivalent mortality up to a median follow up of 2 years compared to SAVR. More data is required before TAVI can be routinely considered as an alternative for SAVR in low risk patients.



EuroIntervention: 30 Sep 2019; epub ahead of print
Witberg G, Landes U, Lador A, Yahav D, Kornowski R
EuroIntervention: 30 Sep 2019; epub ahead of print | PMID: 31566571
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Impact:
Abstract

Increased mortality among patients with higher right ventricular volumes: Volumetric analysis of pre-trans-catheter aortic valve replacement CT Angiography.

Rozenbaum Z, Maret E, Lax L, Shmilovich H, ... Fleischmann D, Aviram G
Aims
To assess prognostic implications of increased right ventricle volume index (RVVI) using cardiac-gated computed tomography angiography (CCTA) data among patients undergoing trans-catheter valve implantation (TAVR).
Methods and results
CCTA of 323 patients who underwent TAVR at Stanford University Medical Center (California, USA) and Tel Aviv Medical Center (Israel) between 2013-2016 were analyzed by an automatic 4-chamber volumetric software and grouped into quartiles according to their RVVI. Higher 1-year mortality rates were noted for the upper quartiles - 5%, 4.9%, 8.6%, and 16% (p=0.039), in Q1<59 ml/m2, Q2 59-69 ml/m2, Q3 69-86 ml/m2, and Q4>83 ml/m2, respectively. However, the differences were not significant after propensity score adjustments. Sub-analyses of Q1 demonstrated an escalating risk for 1-year mortality in concordance to RVVI; HR 2.28, HR 2.76, and HR 4.7, for the upper 25th, 15th, and 5th percentiles, respectively (p<0.05 for all comparisons). After propensity score adjustments for clinical and echocardiographic characteristics only the upper 5th percentiles (RVVI>120 ml/m2) retained statistical significance (HR 2.82, 95% CI 1.02-7.78, p=0.045). Notably, 68.7% of patients from this group were considered low-intermediate risk for surgery.
Conclusions
Cardiac volumetric data by CCTA performed for procedural planning may help predict outcome in patients undergoing TAVR.



EuroIntervention: 30 Sep 2019; epub ahead of print
Rozenbaum Z, Maret E, Lax L, Shmilovich H, ... Fleischmann D, Aviram G
EuroIntervention: 30 Sep 2019; epub ahead of print | PMID: 31566570
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Impact:
Abstract

Early Hemodynamic Changes and Long-Term Outcome Of Patients With Severe Low Gradient Aortic Stenosis After Transcatheter Aortic Valve Replacement.

Schewel J, Schlüter M, Schmidt T, Kuck KH, Frerker C, Schewel D
Aims
Approximately 40% of severe aortic stenosis (AS) patients have a low-gradient (<40mmHg) AS (LG-AS). The aim was to investigate the invasively measured hemodynamic changes and long-term outcome after transcatheter aortic valve replacement (TAVR) in the subgroups of LG-AS.
Methods and results
A total of 600 LG-AS patients with hemodynamic assessment by left and right heart catheterization were divided into three groups: normal-flow (NFLG-AS; n=296), paradoxical low-flow (PLFLG-AS; n=153), classical low-flow (CLFLG-AS; n=151). Post-TAVR, PLFLG-AS and CLFLG-AS showed a significant reduction in global afterload (p<0.005), as well as a significant elevation of stroke volume index (SVI), left and right ventricular stroke work index (p<0.001). NFLG-AS was associated with elevation of global afterload and a decrease of SVI (p<0.05). Overall survival was highest in NFLG-AS, followed by PLFLG-AS and CLFLG-AS. All subgroups experienced similar symptomatic improvement.
Conclusions
NFLG-AS was the most prevalent form of LG severe AS and was associated with adequate left ventricular compensation and good prognosis. On the other hand, CLFLG-AS represents the heart-failure with reduced ejection fraction (HFrEF) form of AS and was associated with the worst prognosis, whereas PLFLG-AS represents the heart-failure with preserved ejection fraction (HFpEF) form of AS with intermediary prognosis. Both groups showed early hemodynamic reverse response after TAVR.



EuroIntervention: 30 Sep 2019; epub ahead of print
Schewel J, Schlüter M, Schmidt T, Kuck KH, Frerker C, Schewel D
EuroIntervention: 30 Sep 2019; epub ahead of print | PMID: 31566569
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Impact:
Abstract

Incidence and predictors of outcomes after a first definite coronary stent thrombosis.

Tovar Forero MN, Zanchin T, Masdjedi K, van Zandvoort LJC, ... Räber L, Daemen J
Aims
Stent thrombosis (ST) is a rare but potentially fatal complication of coronary artery stenting. Little is known about the optimal treatment strategy at the time of a ST event. We identified the incidence and predictors of adverse cardiac events after treatment of a definite ST.
Methods and results
695 patients with definite ST were included between 1996 and 2017 in 2 academic medical centres. The primary endpoint was the composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) (MACE). Mean age was 62.8 ± 12.1 years and 76.3% were male. ST occurred at a median of 22 days (IQR 3-551 days); 50.8% were early and 49.2% were late/very late ST. At 60 months follow-up, MACE was 43.7%, cardiac death 19.5%, MI 17.9%, TVR 24.8%, and repeat definite ST was 12.1% (10.5% in target vessel). Independent predictors of MACE were cardiogenic shock (HR 2.54; 95%CI 1.75-3.70; p<0.001), ST in LAD (HR 1.76; 95%CI 1.32-2.35; p<0.001) prior CVA/TIA (HR 1.68; 95%CI 1.08-2.62; p=0.020), peripheral vascular disease (HR 1.55; 95%CI 1.00-2.39; p=0.046), multivessel disease (HR 1.53; 95%CI 1.12-2.08; p=0.007), and final TIMI flow 2-3 (HR 0.54; 95% CI 0.34-0.85; p=0.009). No specific treatment of ST influenced MACE, however, new generation P2Y12 inhibitors reduced the risk of MI (HR 0.56; 95% CI 0.32-0.99; p=0.049).
Conclusions
The incidence of adverse events remains high after a first episode of ST. New generation P2Y12 inhibitors reduce the risk of MI. Additional stenting, GpIIb/IIIa inhibitors and thrombectomy did not improve outcomes following ST.



EuroIntervention: 02 Sep 2019; epub ahead of print
Tovar Forero MN, Zanchin T, Masdjedi K, van Zandvoort LJC, ... Räber L, Daemen J
EuroIntervention: 02 Sep 2019; epub ahead of print | PMID: 31475906
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Impact:
Abstract

Three-year clinical and two-year multimodality imaging outcomes of a thin-strut sirolimus-eluting bioresorbable vascular scaffold: MeRes-1 trial.

Seth A, Onuma Y, Chandra P, Bahl VK, ... Abizaid A, Serruys PW
Aims
Although the proof of concept of the bioresorbable vascular scaffold (BRS) is well documented, device-related adverse outcomes with first-generation BRS indicate longer-term surveillance. The current study provides insights into the safety and performance of the MeRes100, a novel second-generation sirolimus-eluting BRS, beyond one-year up to three-year follow-up (FU).
Methods and results
A total of 108 enrolled patients with de novo coronary artery lesions who underwent implantation of MeRes100 as part of the first-in-human MeRes-1 trial were followed up clinically beyond one year at two and three years and with multiple modality imaging at six months and two years. At three-year FU, the cumulative major adverse cardiac events rate was 1.87%, in the form of two ischaemia-driven target lesion revascularisations. No scaffold thrombosis was reported. Between six months and two years at quantitative coronary angiography, in-segment late lumen loss (LLL) (0.15±0.22 mm vs. 0.23±0.32 mm; p=0.18) and in-scaffold LLL (0.13±0.22 mm vs. 0.24±0.34 mm; p=0.10) changed insignificantly. IVUS subset analysis revealed a non-significant reduction in mean lumen area (6.17±1.28 mm2 vs. 5.47±1.50 mm2; p=0.21) and minimum lumen area (5.14±1.19 mm2 vs. 4.05±1.42 mm2; p=0.10) at two years compared to post-procedural measurements. OCT subset analysis demonstrated 99.24±2.27% neointimal strut coverage.
Conclusions
The extended outcomes of the MeRes-1 trial demonstrated sustained efficacy and safety of the MeRes100 BRS with maintained lumen patency up to two years by multimodality imaging and no very late scaffold thrombosis up to three-year clinical FU.The MeRes-1 trial is registered at the Clinical Trials Registry-India. CTRI Number: CTRI/2015/04/005706.



EuroIntervention: 19 Sep 2019; 15:607-614
Seth A, Onuma Y, Chandra P, Bahl VK, ... Abizaid A, Serruys PW
EuroIntervention: 19 Sep 2019; 15:607-614 | PMID: 31147308
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Impact:
Abstract

Comparison of Fractional Flow Reserve, Instantaneous Wave Free Ratio and a Novel Technique for Assessing Coronary Arteries with Serial Lesions.

Modi BN, Rahman H, Ryan M, Ellis H, ... Chowienczyk P, Perera D
Aims
Physiological indices such as fractional flow reserve (FFR), instantaneous wave-free ratio (iFR) and resting distal coronary to aortic pressure (Pd/Pa) are increasingly used to guide revascularisation. However, reliably assessing individual stenoses in serial coronary disease remains an unmet need. This study aimed to compare conventional pressure-based indices, a reference Doppler-based resistance index (Hyperaemic Stenosis Resistance, hSR) and a recently described mathematical correction model to predict the contribution of individual stenoses in serial disease.
Methods and results
Resting and hyperaemic pressure-wire pullbacks were performed in 54 patients with serial disease. For each stenosis, FFR, iFR, Pd/Pa were measured by the trans-lesional gradient in each index and the predicted FFR (FFRpred) derived mathematically from hyperaemic pullback data. \'True\' stenosis significance by each index was assessed following PCI of the accompanying stenosis or measurements made in a large disease-free branch. In 27 patients, Doppler average peak flow velocity (APV), was also measured to calculate hSR (hSR=DP/APV, where DP=trans-lesional pressure gradient). FFR underestimated individual stenosis severity, inversely proportional to cumulative FFR (r=0.5, P<0.001). Mean errors for FFR, iFR and Pd/Pa were 33%, 20% and 24% respectively, and 14% for FFRpred (P<0.001). Stenosis misclassification rates based on FFR 0.80, iFR 0.89 and Pd/Pa 0.91 thresholds were not significantly different (17%, 24% and 20% respectively) but were higher than FFRpred (11%, p<0.001). Apparent and true hSR correlated strongly (r=0.87, p<0.001, mean error 0.19+/-0.3), with only 7% of stenoses misclassified.
Conclusion
Individual stenosis severity is significantly underestimated in the presence of serial disease, using both hyperaemic and resting pressure-based indices. hSR is less prone to error but challenges in optimising Doppler signals limits clinical utility. A mathematical correction model, using data from hyperaemic pressure-wire pullback, produces similar accuracy to hSR and is superior to conventional pressure-based indices.



EuroIntervention: 23 Sep 2019; epub ahead of print
Modi BN, Rahman H, Ryan M, Ellis H, ... Chowienczyk P, Perera D
EuroIntervention: 23 Sep 2019; epub ahead of print | PMID: 31543499
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Impact:
Abstract

Relationship between Extent of Ischaemic Burden and Changes in Absolute Myocardial Perfusion after Chronic Total Occlusion Percutaneous Coronary Intervention.

Schumacher SP, Kockx M, Stuijfzand WJ, Driessen RS, ... Nap A, Knaapen P
Aims
Exploring relationships between ischaemic burden and changes in absolute myocardial perfusion following chronic coronary total occlusion (CTO) percutaneous coronary intervention (PCI).
Methods and results
193 consecutive patients underwent [15O]H2O positron emission tomography prior and 3 months after successful CTO PCI. Change in perfusion defect size, quantitative hyperaemic myocardial blood flow (MBF) and coronary flow reserve (CFR) within the CTO area were compared between patients with limited (0-1 segment, N=15), moderate (2-3 segments, N=61) and large (≥4 segments, N=117) perfusion defects. Median reductions in defect size were 1 [0-1], 2 [1-3], and 4 [2-5] segments in patients with a limited, moderate and large defect (all comparisons p<0.01). Hyperaemic MBF and CFR improved significantly regardless of baseline defect size (overall between groups p=0.45 and p=0.55). After stratification of patients to a low, intermediate or high tertile according to baseline hyperaemic MBF or CFR levels, changes in hyperaemic MBF and CFR after CTO PCI were comparable between tertiles (overall p=0.75 and p=0.79).
Conclusions
Major reductions in ischaemic burden can be achieved following CTO PCI, with more defect size reduction in patients with a larger perfusion defect, whereas hyperaemic MBF and CFR improve significantly irrespective of their baseline values or perfusion defect size.



EuroIntervention: 23 Sep 2019; epub ahead of print
Schumacher SP, Kockx M, Stuijfzand WJ, Driessen RS, ... Nap A, Knaapen P
EuroIntervention: 23 Sep 2019; epub ahead of print | PMID: 31543497
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Impact:
Abstract

Coronary artery perforation during chronic total occlusion percutaneous coronary intervention: epidemiology, mechanisms, management, and outcomes.

Azzalini L, Poletti E, Ayoub M, Ojeda S, ... Carlino M, Mashayekhi K
Aims
The aim of this study was to describe the epidemiology, mechanisms, management, and outcomes of coronary artery perforation during chronic total occlusion (CTO) percutaneous coronary intervention (PCI).
Methods and results
We included 1,811 consecutive patients undergoing CTO PCI at five centres between 2011 and 2018. Coronary perforation was observed in n=99 (5.5%). Patients with perforation were older, had a higher J-CTO score, more often required antegrade dissection/re-entry and the retrograde approach, and had lower success rates. The frequency of Ellis type I, II, III and III \"cavity spilling\" perforations was 11%, 46%, 28%, and 14%, respectively. In 48% of cases, perforation involved the CTO vessel, while the retrograde approach was responsible for 46% of cases. In 53% of cases perforations required intervention. The most frequently applied management strategies included clinical observation (47%), covered stent implantation (25%), balloon occlusion (9%), and coil/fat embolisation (9%). Tamponade was observed in 20/99 (20%) perforation cases. Ellis type III perforations were most frequently observed at the CTO site. These were accountable for 16/20 tamponades and 3/5 deaths. In-hospital mortality was 5.1% vs 0.3% in patients with versus those without perforation (p<0.001). Older age, occlusion length >20 mm, rotational atherectomy, antegrade dissection/re-entry, and the retrograde approach were independently associated with coronary perforation. Patients with perforation suffered an increased incidence of target vessel failure on short-term follow-up.
Conclusions
Coronary perforation is observed in a non-negligible proportion of CTO PCIs, often requires intervention, and is associated with tamponade and mortality in a minority of patients. CTO vessel-related perforations are associated with the highest burden of morbidity and mortality.



EuroIntervention: 03 Oct 2019; 15:e804-e811
Azzalini L, Poletti E, Ayoub M, Ojeda S, ... Carlino M, Mashayekhi K
EuroIntervention: 03 Oct 2019; 15:e804-e811 | PMID: 31217142
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Impact:
Abstract

Vascular complications in Transaxillary TAVI: Incidence and predictors incorporating CTA measurements.

van der Wulp K, Thijs I, van Wely M, Loverbos A, ... Morshuis W, van Royen N
Aims
Vascular complications are among the most common observed complications after TAVI. Ileofemoral vascular outcome has been described extensively. Little is known about vascular complications in transaxillary TAVI. The aim of the current study was to describe the incidence and predictors of axillary artery complications incorporating Computed Tomography Angiography (CTA) measurements.
Methods and results
CT analysis was performed in two-hundred patients treated with transaxillary TAVI in our centre between January 2014 and December 2017. Vascular complications occurred in 37 (18.5%) patients. Patient characteristics predicting this outcome were female gender (aOR 3.88 [1.48-10.14], p = 0.006) and age (aOR 1.08 [1.01-1.16], p = 0.034). The CTA measurement predicting vascular complications was a sheath to artery area ratio (SAAR) equal to or larger than 1.63 (OR 3.95 [1.29-12.12], p = 0.016).
Conclusions
The present study described the incidence of axillary artery complications and identified patient characteristics associated with this outcome. CTA analysis was shown to be an important screening tool in the assessment of patient\'s (access) eligibility. Axillary artery dimensional screening should be based on vascular luminal area assessment rather than diameter measurement alone.



EuroIntervention: 16 Sep 2019; epub ahead of print
van der Wulp K, Thijs I, van Wely M, Loverbos A, ... Morshuis W, van Royen N
EuroIntervention: 16 Sep 2019; epub ahead of print | PMID: 31532395
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Impact:
Abstract

Myocardial fibrosis in patients undergoing transcatheter aortic valve replacement: impact on left ventricular reverse remodeling and long-term outcome.

Sugiura A, Weber M, von Depka A, Tabata N, ... Sinning JM, Sedaghat A
Aims
We sought to investigate the relevance of myocardial fibrosis, assessed by mid-wall fibrosis risk (MFR) score, with respect to left ventricular (LV) reverse remodeling following transcatheter aortic valve replacement (TAVR).
Methods and results
Between January 2010 and March 2015, we enrolled 207 patients in whom baseline MFR, which includes age, sex, high-sensitive cardiac troponin-I, presence of strain pattern on electrocardiograph, and peak-aortic valve velocity, as well one-year follow-up echocardiography were available. LV reverse remodeling was defined as a >10 % reduction in LV end-diastolic volume index (LVEDVi). A higher MFR score (≥52) was associated with increased LVEDVi and with decreased LV ejection fraction as well as higher baseline-NT-pro-BNP levels (p<0.05 for all). One year after the TAVR procedure, a higher MFR score was associated with a decreased probability of LV reverse remodeling (OR 0.33; 95% CI, 0.23-0.87; p=0.03), which was independent of baseline echocardiographic parameters and comorbidities. In contrast, there was no significant difference in five-year mortality between patients with lower and higher MFR score (57.9% vs. 60.5%, p=0.66).
Conclusions
A higher MFR score is associated with reduced LV reverse remodeling at one-year follow-up, whereas the MFR score does not appear to interfere with long-term mortality after TAVR.



EuroIntervention: 16 Sep 2019; epub ahead of print
Sugiura A, Weber M, von Depka A, Tabata N, ... Sinning JM, Sedaghat A
EuroIntervention: 16 Sep 2019; epub ahead of print | PMID: 31532394
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Impact:
Abstract

Allogeneic Cardiosphere-derived Cells for the Treatment of Heart Failure with Reduced Ejection Fraction: Results of the Dilated cardiomYopathy iNtervention with Allogeneic Myocardially-regeneratIve Cells (DYNAMIC) trial.

Chakravarty T, Henry TD, Kittleson M, Lima J, ... Marbán E, Makkar RR
Aims
The DYNAMIC trial assessed the safety and explored the efficacy of multivessel intracoronary infusion of allogeneic cardiosphere-derived cells (CDCs) in patients with heart failure and reduced ejection fraction (HFrEF).
Methods and results
We enrolled 14 patients with EF≤35% and NYHA III-IV despite maximal medical- and device-based therapy in this single-center, open-label trial. Intracoronary catheterization delivered four escalating doses (totaling 37.5-75 million cells) by sequential non-occlusive technique to all three major coronary arteries. The primary safety endpoint was a composite of post-infusion TIMI flow, ventricular tachycardia/fibrillation, sudden death, major adverse cardiac events or acute myocarditis within 72 hours. Twelve patients were male and EF averaged 23.0% (±4.5%). No primary safety endpoints were observed. Two patients died of HFrEF progression 9- and 12-months following infusion. Compared to baseline, there was an improvement in EF (26.8% vs. 22.9%, p=0.023) and left ventricular end-systolic volume (139.5 vs. 177.8, p=0.03) at 6 months. Quality of life (QoL) scores and NYHA class (p=0.006) improved at 6 months. At 12 months, the improvement in EF and QoL remained significant.
Conclusions
Global intracoronary infusion of allogeneic CDCs is safe and feasible. The efficacy of allogeneic CDCs in HFrEF needs to be tested in larger randomized trials.



EuroIntervention: 25 Nov 2019; epub ahead of print
Chakravarty T, Henry TD, Kittleson M, Lima J, ... Marbán E, Makkar RR
EuroIntervention: 25 Nov 2019; epub ahead of print | PMID: 31763984
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Impact:
Abstract

Predictors of long-term adverse events after Absorb bioresorbable vascular scaffold implantation: a 1,933-patient pooled analysis from international registries.

Caixeta A, Campos CM, Felix C, Chieffo A, ... Serruys PW, Abizaid A
Aims
The aim of this study was to investigate the predictors of long-term adverse clinical events after implantation of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS).
Methods and results
We pooled patient-level databases derived from the large-scale ABSORB EXTEND study and five high-volume international centres. Between November 2011 and November 2015, 1,933 patients underwent PCI with a total of 2,372 Absorb BVS implanted. The median age was 61.0 (IQR 53.0 to 68.6) years, 24% had diabetes, and 68.2% presented with stable coronary artery disease. At a median follow-up of 616 days, MACE occurred in 93 (4.9%) patients, all-cause death in 36 (1.9%) patients, myocardial infarction in 47 (2.5%) patients, and target vessel revascularisation in 72 (3.8%) patients. Definite or probable scaffold thrombosis occurred in 26 (1.3%) patients. On multivariable logistic regression analysis, acute coronary syndromes (hazard ratio [HR] 2.79, 95% confidence interval [CI]: 1.47 to 5.29; p=0.002), dyslipidaemia (HR 1.43, 95% CI: 1.23 to 1.79; p=0.007), scaffold/reference diameter ratio >1.25 (HR 1.49, 95% CI: 1.18 to 1.88; p=0.001), and residual stenosis >15% (HR 1.67, 95% CI: 1.34 to 2.07; p<0.001) were independent predictors of MACE, whereas the use of intravascular imaging was independently associated with a reduction in MACE (HR 0.13, 95% CI: 0.06 to 0.28; p<0.001).
Conclusions
Optimal Absorb BVS implantation and the use of intravascular imaging guidance are associated with lower rates of adverse events at long-term follow-up.



EuroIntervention: 19 Sep 2019; 15:623-630
Caixeta A, Campos CM, Felix C, Chieffo A, ... Serruys PW, Abizaid A
EuroIntervention: 19 Sep 2019; 15:623-630 | PMID: 30375335
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Impact:
Abstract

Quantitative aortography for assessing aortic regurgitation after transcatheter aortic valve implantation: results of the multicentre ASSESS-REGURGE Registry.

Modolo R, Chang CC, Tateishi H, Miyazaki Y, ... Van Mieghem NM, Serruys PW
Aims
Quantitative aortography using videodensitometry is a valuable tool for quantifying paravalvular regurgitation after TAVI, especially in the minimalist approach - without general anaesthesia. However, retrospective assessment of aortograms showed moderate feasibility of assessment. We sought to determine the prospective feasibility of quantitative aortography after a protocol of acquisition.
Methods and results
This was a multicentre registry in Japan, Canada, the Netherlands and Germany including consecutive patients with Heart Team indication to undergo TAVI over a median period of 12 months. Operators performed final aortograms according to a pre-planned projection (either by CT or visually - Teng\'s rule). An independent core laboratory (Cardialysis) analysed all images for feasibility and for regurgitation assessment. From the four centres included in the present analysis, a total of 354 patients underwent TAVI following the acquisition protocol and all the aortograms were analysed by the core lab. The analyses were feasible in 95.5% (95% confidence interval [CI]: 93.2% to 97.5%) of the cases. This rate of analysable assessment was significantly higher than the feasibility in previous validation studies, such as in the RESPOND population (95.5% vs. 57.5%, p<0.0001). No differences were observed among different planning strategies (CT 96.5% vs. Teng\'s rule 93%, p=0.159; or Circle 98.5% vs. 3mensio 95.8% vs. Teng\'s rule 93%, p=0.247).
Conclusions
ASSESS-REGURGE showed a high feasibility of assessment of regurgitation with quantitative aortography with protocoled acquisition. This may be of great importance for quantifying regurgitation in TAVI procedures (optimisation, guidance of post-dilatation), and in future clinical trials, in order to address sealing features of novel devices for TAVI objectively. ClinicalTrials.gov Identifier: NCT03644784.



EuroIntervention: 28 Aug 2019; 15:420-426
Modolo R, Chang CC, Tateishi H, Miyazaki Y, ... Van Mieghem NM, Serruys PW
EuroIntervention: 28 Aug 2019; 15:420-426 | PMID: 31147307
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Impact:
Abstract

In vivo intravascular photoacoustic imaging of plaque lipid in coronary atherosclerosis.

Iskander-Rizk S, Wu M, Springeling G, van Beusekom HMM, ... Wentzel JJ, van Soest G

Prospective identification of lipid-rich vulnerable plaque has remained an elusive goal. Intravascular photoacoustics, a hybrid optical and ultrasonic technology, was developed as a tool for lipid-rich plaque imaging. Here, we present the first in vivo images of lipid-rich coronary atherosclerosis acquired with this new technology in a large animal model, and relate them to independent catheter-based imaging and histology.



EuroIntervention: 28 Aug 2019; 15:452-456
Iskander-Rizk S, Wu M, Springeling G, van Beusekom HMM, ... Wentzel JJ, van Soest G
EuroIntervention: 28 Aug 2019; 15:452-456 | PMID: 31113762
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Impact:
Abstract

Treatment with a dedicated bifurcation sirolimus-eluting cobalt-chromium stent for distal left main coronary artery disease: rationale and design of the POLBOS LM study.

Asano T, Kogame N, Onuma Y, Modolo R, ... Serruys PW, Gil RJ
Aims
To demonstrate the noninferiority of the BiOSS LIM C sirolimus-eluting cobalt-chromium bifurcation dedicated stent against the Xience stent regarding patients oriented composite endpoint (POCE) at 12 months among patients with left main coronary artery disease (LMCA).
Methods and results
The POLBOS LM study is a single-arm prospective multi-centre study enrolling 260 patients (SYNTAX score ≤32) with pre-specified performance goal based on the results of the EXCEL trial with contemporary percutaneous coronary intervention (PCI) for LMCA disease. Patient enrollment will comply with objective inclusion criteria of diameter stenosis ≥50% in LMCA based on off-line quantitative coronary angiography (QCA) analyzed by an independent core laboratory using dedicated-bifurcation QCA software. The BiOSS LIM C is used for the treatment of LMCA disease with the specific technical classification for the BiOSS LIM (modified MADS classification) and the stent implantation is optimized by using pre-specified intravascular ultrasound criteria. Primary endpoint is POCE (a composite of all-cause death, stroke, any myocardial infarction, and any revascularization) at 12 months.
Conclusion
The POLBOS LM study will indicate the efficacy of BiOSS LIM C stent with contemporary PCI for distal left main bifurcation lesions in comparison with the XIENCE stent from the recent EXCEL trial, as a performance index.



EuroIntervention: 23 Sep 2019; epub ahead of print
Asano T, Kogame N, Onuma Y, Modolo R, ... Serruys PW, Gil RJ
EuroIntervention: 23 Sep 2019; epub ahead of print | PMID: 31543500
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Impact:
Abstract

New-generation mechanical circulatory support during high-risk PCI: a cross-sectional analysis.

Ameloot K, B Bastos M, Daemen J, Schreuder J, ... Zijlstra F, Van Mieghem NM
Aims
The aim of the study was to establish the value of new-generation mechanical circulatory support (MCS) devices such as HeartMate PHP, Impella CP and PulseCath iVAC2.
Methods and results
We retrospectively analysed all consecutive elective high-risk PCI procedures performed in the Erasmus Medical Center (2011-2018) in order to compare MCS protected and unprotected patients. The primary endpoint was a composite of procedure-related adverse events including death (<24 hours), cardiac arrest, need for vasopressors, rescue MCS, endotracheal intubation and limb ischaemia with need for surgery. Secondary endpoints included 30-day survival. A total of 198 elective high-risk PCI patients were included (69 [35%] MCS protected, 129 [65%] MCS unprotected). When compared with unprotected patients, MCS protected patients had a significantly worse left ventricular ejection fraction (LVEF) (25±10 vs 33±8%, p<0.01) and higher SYNTAX I score (33±11 vs 24±8, p<0.01). The primary endpoint occurred in 26 (20%) of the unprotected patients and in 6 (9%) of the MCS protected patients (OR 0.38, 95% CI: 0.15-0.97, p=0.04). Patients under 75 years of age, with a SYNTAX I score above 32 and with an LVEF below 30% showed most potential benefit from MCS. Survival during the first 24 hours after the procedure and at 30 days was significantly higher in MCS protected patients (100% vs 95%, p=0.04 at 24 hours, and 98% vs 87%, OR 10.32, 95% CI: 1.34-79.31, p=0.006 at 30 days).
Conclusions
In a consecutive real-world cohort of high-risk PCI patients, protection with new-generation MCS resulted in better procedural outcomes despite worse EF and more complex coronary artery disease at baseline. Larger prospective studies are needed to confirm these findings.



EuroIntervention: 28 Aug 2019; 15:427-433
Ameloot K, B Bastos M, Daemen J, Schreuder J, ... Zijlstra F, Van Mieghem NM
EuroIntervention: 28 Aug 2019; 15:427-433 | PMID: 30741638
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Impact:
Abstract

Double kissing mini-culotte versus mini-culotte stenting: insights from micro-computed tomographic imaging of bench testing.

Hu F, Tu S, Cai W, Jiang Z, ... Yao Y, Chen L
Aims
This study aimed to evaluate the morphologic characteristics of double kissing (DK) mini-culotte and mini-culotte stenting through imaging of bench testing.
Methods and results
DK mini-culotte and mini-culotte stenting were performed in two silicone bifurcated phantoms with branch vessel diameter differences of 0.5 mm (Model 1) and 1.25 mm (Model 2), and their morphologic characteristics were evaluated by micro-computed tomography. In Model 1, metal carina length (0.25±0.13 mm vs 0.55±0.15 mm), area stenosis of the side branch ostium (SBO) (4.65±3.24% vs 12.5±3.93%), and maximum distance of malapposed struts for the wall facing the SBO (0.27±0.08 mm vs 0.49±0.15 mm) were lower in the DK mini-culotte group than in the mini-culotte group. In Model 2, metal carina length (0.21±0.47 mm vs 0.47±0.12 mm), SBO area stenosis (5.13±3.37% vs 15.00±6.18%), and maximum distance of malapposed struts (0.32±0.13 mm vs 0.68±0.10 mm) were also lower in the DK mini-culotte group. The results of factorial analysis showed that maximum distance of malapposed struts tended to be shorter in Model 1 (F=4.226, p=0.062).
Conclusions
Compared with mini-culotte stenting, DK mini-culotte stenting was associated with shorter metal carina length, shorter maximum distance of malapposed struts, and smaller SBO area stenosis. Thus, DK mini-culotte stenting may obtain better morphologic characteristics.



EuroIntervention: 28 Aug 2019; 15:465-472
Hu F, Tu S, Cai W, Jiang Z, ... Yao Y, Chen L
EuroIntervention: 28 Aug 2019; 15:465-472 | PMID: 30530401
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Impact:
Abstract

The AFR-PRELIEVE trial: a prospective, non-randomised, pilot study to assess the Atrial Flow Regulator (AFR) in heart failure patients with either preserved or reduced ejection fraction.

Paitazoglou C, Özdemir R, Pfister R, Bergmann MW, ... Sievert H, Mahfoud F
Aims
Reducing elevated left atrial pressure with an atrial septum shunt device is a possible treatment option in symptomatic heart failure patients. This study aimed to investigate the safety and feasibility of the Atrial Flow Regulator (AFR) in heart failure patients.
Methods and results
AFR-PRELIEVE is a prospective, non-randomised, open-label, multicentre study in patients with symptomatic heart failure NYHA Class III or IV and pulmonary capillary wedge pressure (PCWP) ≥15 mmHg at rest or ≥25 mmHg at exercise irrespective of left ventricular ejection fraction (EF ≥15%). Here we report on procedural and three-month follow-up data for a total of thirty-six enrolled patients. Sixteen (44.5%) patients with reduced EF (HFrEF: EF 15-39%) and twenty (55.5%) patients with preserved EF (HFpEF: EF ≥40%) were enrolled. Implantation success rate and device patency with left-right shunt was 100% (post procedure and at three months) in both patient groups, with one SADE in the HFpEF group which completely resolved. Three (3/36, 8.3%) patients were hospitalised for worsening of heart failure (two HFrEF patients, one HFpEF patient). Individual patients from both the HFrEF and HFpEF groups showed improvement in symptoms and surrogate parameters of heart failure (NYHA class, six-minute walking distance, Kansas City Cardiomyopathy Questionnaire, PCWP, NT-proBNP).
Conclusions
Implantation of the AFR device in heart failure patients is feasible and safe; shunt patency at three months was confirmed in the study. The atrial shunt improved symptoms and surrogate parameters of heart failure in some but not all patients in both the HFpEF and HFrEF groups.



EuroIntervention: 28 Aug 2019; 15:403-410
Paitazoglou C, Özdemir R, Pfister R, Bergmann MW, ... Sievert H, Mahfoud F
EuroIntervention: 28 Aug 2019; 15:403-410 | PMID: 31130524
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Impact:
Abstract

Transcatheter Mitral Valve Replacement: Factors Associated with Screening Success and Failure.

Coisne A, Pontana F, Tchétché D, Richardson M, ... Dumonteil N, Modine T
Aims
Transcatheter mitral valve replacement (TMVR) is a promising therapeutic solution to treat high-risk patients with severe mitral regurgitation (MR) contraindicated to surgery. Optimal selection of patients who will benefit from the procedure is of paramount. We aimed at investigating factors associated with TMVR screening.
Methods and results
From November 2016 to July 2018, we examined conditions associated with TMVR screening success in patients referred to the two French Heart Valve Clinics with the greatest TMVR experience. Among a total of 40 consecutive screened patients, 16 (40%) were selected for TMVR (8 Twelve Intrepid, 7 Tendyne and 1 HighLife), while 24 patients (60%) were refused for TMVR mainly for too large mitral annulus (MA) (n=15,62% of refusal), or too small anatomy and risk of neo-left ventricular outflow tract (LVOT) obstruction (n=6,25% of refusal). Patients with suitable anatomy for TMVR were more often male and suffered more frequently from secondary MR (p=0.01) associated with previous myocardial infarction and presented commissure-to-commissure diameter lower than 39mm (AUC=0.72, p=0.0085) and LVESD larger than 32mm (AUC=0.83, p<0.0001) on transthoracic echocardiography and MA area lower than 17.6cm² (AUC=0.95, p<0.0001) and anteroposterior diameter higher than 41.6mm (AUC=0.87, p<0.001) on CT-scan.
Conclusions
Despite several prostheses available, most patients referred to Heart Valve Clinics and good candidate regarding their clinical profile cannot be implanted with TMVR because of mismatch between their anatomy and prosthesis characteristics. Our findings suggest the need to develop new prosthesis adapted to larger MA but with lower impact on the LVOT.



EuroIntervention: 26 Aug 2019; epub ahead of print
Coisne A, Pontana F, Tchétché D, Richardson M, ... Dumonteil N, Modine T
EuroIntervention: 26 Aug 2019; epub ahead of print | PMID: 31449044
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Impact:
Abstract

Amplatzer left atrial appendage closure: access via transseptal puncture versus patent foramen ovale or atrial septal defect.

Kleinecke C, Fuerholz M, Buffle E, de Marchi S, ... Meier B, Gloekler S
Aims
To compare periprocedural and late clinical outcomes of left atrial appendage closure (LAAC) with Amplatzer devices by access through transseptal puncture (TSP) versus a patent foramen ovale (PFO) or an atrial septal defect (ASD).
Methods and results
Between 2009 and 2018, 578 consecutive patients underwent LAAC via TSP or PFO/ASD access in three centers. After a 1:3 propensity score matching, 246 (TSP) vs 246 (PFO/ASD) patients were compared by use of the primary efficacy endpoint of all-cause stroke, systemic embolism and cardiovascular/unexplained death and the primary safety endpoint of major peri-procedural complications and major bleedings at follow-up. Mean age was 75.2±8.7 (TSP) vs 74.4±10.9 (PFO/ASD) years, CHA2DS2-VASc score 4.5±1.6 vs 4.3±1.4, and HAS-BLED score 3.3±1.0 vs 3.3±0.9. Device success (97.6% vs 97.8%, p=0.90) was similar. After 2.5±1.4 vs 2.6±1.6 years, clinical efficacy (46/603, 7.6% [TSP] vs 21/233, 9.0% [PFO/ASD], 10.3, hazard ratio (HR), 1.2; 95% confidence interval (CI), 0.69-0.85, p=0.54) and safety (24/603, 4.0% vs 11/233, 4.7%; HR, 1.4; 95% CI, 0.52-3.6, p=0.49) did not differ.
Conclusions
Use of a PFO/ASD access for LAAC with Amplatzer devices offers similar periprocedural and late clinical outcomes as TSP. Simultaneous PFO/ASD closure for an additional protective benefit does not increase risk.



EuroIntervention: 26 Aug 2019; epub ahead of print
Kleinecke C, Fuerholz M, Buffle E, de Marchi S, ... Meier B, Gloekler S
EuroIntervention: 26 Aug 2019; epub ahead of print | PMID: 31449043
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Impact:
Abstract

Defining Device Success for Percutaneous Coronary Intervention Trials: A Position Statement from the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology.

Chang CC, Kogame N, Onuma Y, Byrne RA, ... Baumbach A, Serruys PW

Percutaneous coronary intervention with implantation of drug-eluting stents has become the most commonly performed revascularization procedure in patients with symptomatic coronary artery disease. Continuous iterations of coronary devices incorporating changes in platform materials, geometry, strut thickness, drug-release mechanisms and anti-proliferative drugs, have progressively reduced the rate of device-related adverse clinical events, and objective performance criteria have been proposed for clinical and angiographic outcomes of drug-eluting stents. The rate of device success has been recognized as an intra-procedural endpoint to evaluate the mechanical ability to complete a procedure with the specific device assigned by protocol in randomized comparative trials. The European Commission and the U.S. Food and Drug Administration both provide guidance documents including the mechanistic evaluation of coronary stents which recommend operational definitions of device success. While the majority of clinical trials investigating drug-eluting stents have adopted this endpoint definition, inconsistencies in application limit the reliability of comparisons across different trials reporting device success rates. In addition, it is not uncommon that device success rates are not reported by investigators. A consistent definition of device success is essential to allow scientific comparisons of this technical performance endpoint between devices across different trials. Therefore, we performed a systematic evaluation of definitions and reporting of device success in clinical trials. We propose an extended definition as well as considerations for approaching the determination of the device success rates in future percutaneous coronary intervention trials.



EuroIntervention: 02 Sep 2019; epub ahead of print
Chang CC, Kogame N, Onuma Y, Byrne RA, ... Baumbach A, Serruys PW
EuroIntervention: 02 Sep 2019; epub ahead of print | PMID: 31475907
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Impact:
Abstract

Cost-Effectiveness of Transcatheter versus Surgical Aortic Valve Replacement inPatients at Lower Surgical Risk: Results from the NOTION Trial.

Geisler BP, Jørgensen TH, Thyregod HGH, Pietzsch JB, Søndergaard L
Aims
To estimate the cost-effectiveness of transcatheter aortic valve implantation (TAVI) vs surgical aortic valve replacement (SAVR) in patients at lower surgical risk.
Methods and results
Discounted costs from a societal perspective and effectiveness as quality-adjusted life years (QALYs) were projected to lifetime via a decision-analytic model calibrated to 60-month data from the NOTION trial. The base case assumed a scenario in which any mortality benefit would gradually fade out over time, with other scenarios explored in sensitivity analyses. The incremental cost-effectiveness ratio (ICER) was compared to the country-specific willingness-to-pay (WTP) threshold of 1.13 million Danish kroner (DKK).The base case ICER was DKK696,264/QALY (around €72,100/QALY via purchasing parity adjustment). Variation in long-term mortality beyond 5 years led to limited variation of incremental costs (DKK64,200 to 64,600), but a more pronounced variation in incremental QALYs (0.07 to 0.19 QALYs for most conservative and optimistic assumptions, compared to base case of 0.09 QALYs). All resulting ICERs (range DKK334,200 to DKK904,100 per QALY gained) were below the WTP threshold.
Conclusions
TAVI in a cohort of primarily low-surgical-risk patients was found to be a cost-effective treatment strategy in the Danish healthcare system. Cost-effectiveness analyses in other settings are warranted as are registries given the sensitivity of the model to long-term mortality.



EuroIntervention: 19 Aug 2019; epub ahead of print
Geisler BP, Jørgensen TH, Thyregod HGH, Pietzsch JB, Søndergaard L
EuroIntervention: 19 Aug 2019; epub ahead of print | PMID: 31422922
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Impact:
Abstract

Bioprosthetic valve fracture performed before versus after valve-in-valve intervention: Insights from bench testing.

Sathananthan J, Fraser R, Hatoum H, Barlow AM, ... Wood DA, Webb JG
Aims
Bioprosthetic valve fracture(BVF) may improve transvalvular gradients and transcatheter heart valve(THV) expansion during VIV interventions. However, the optimal timing of BVF is unknown. We assessed the impact of timing of BVF for valve-in-valve(VIV) intervention, on hydrodynamic function and THV expansion.
Methods and results
Three THV designs were assessed, a 23mm SAPIEN 3(S3), small ACURATE neo(ACn) and 23mm Evolut R, deployed into 21mm Mitroflow bioprosthetic surgical valves. We evaluated each THV in three groups: 1)No BVF, 2)BVF before VIV and 3)BVF after VIV. Hydrodynamic testing was performed using a pulse duplicator to ISO 5840:2013 standard. Transvalvular gradients were lower when BVF was performed after VIV for the S3(No BVF 15.5mmHg, BVF before VIV 8.0mmHg, BVF after VIV 5.6mmHg), and the ACn(No BVF 9.8mmHg, BVF before VIV 8.4mmHg, BVF after VIV 5.1mmHg). Transvalvular gradients were similar for the Evolut R, irrespective of performance of BVF or timing of BVF. BVF performed after VIV resulted in better expansion in all three THV designs. The ACn and Evolut R samples all had a mild degree of pinwheeling, and BVF timing did not impact pinwheeling severity. The S3 samples had severe pinwheeling with no BVF, and significant improvement in pinwheeling when BVF was performed after VIV.
Conclusions
BVF performed after VIV was associated with superior THV expansion in all three tested THVs designs, with lower residual transvalvular gradients in the S3 and ACn THVs. The Evolut R had similar hydrodynamic performance irrespective of BVF timing. Timing of BVF has potential implications on THV function.



EuroIntervention: 23 Dec 2019; epub ahead of print
Sathananthan J, Fraser R, Hatoum H, Barlow AM, ... Wood DA, Webb JG
EuroIntervention: 23 Dec 2019; epub ahead of print | PMID: 31854302
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Impact:
Abstract

Clinical use of intracoronary imaging. Part 2: acute coronary syndromes, ambiguous coronary angiography findings, and guiding interventional decision-making: an expert consensus document of the European Association of Percutaneous Cardiovascular Interventions.

Johnson TW, Räber L, Di Mario C, Bourantas CV, ... Mintz GS, Guagliumi G

This consensus document is the second of two reports summarizing the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) on the clinical use of intracoronary imaging including intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS)-IVUS. Beyond guidance of stent selection and optimization of deployment, invasive imaging facilitates angiographic interpretation and may guide treatment in acute coronary syndrome. Intravascular imaging can provide additional important diagnostic information when confronted with angiographically ambiguous lesions and allows assessment of plaque morphology enabling identification of vulnerability characteristics. This second document focuses on useful imaging features to identify culprit and vulnerable coronary plaque, which offers the interventional cardiologist guidance on when to adopt an intracoronary imaging-guided approach to the treatment of coronary artery disease and provides an appraisal of intravascular imaging-derived metrics to define the haemodynamic significance of coronary lesions.



EuroIntervention: 28 Aug 2019; 15:434-451
Johnson TW, Räber L, Di Mario C, Bourantas CV, ... Mintz GS, Guagliumi G
EuroIntervention: 28 Aug 2019; 15:434-451 | PMID: 31258132
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Impact:
Abstract

Alcohol septal ablation for hypertrophic obstructive cardiomyopathy: a contemporary reappraisal.

Pelliccia F, Niccoli G, Gragnano F, Limongelli G, ... Elliott P, Calabrò P

Percutaneous alcohol septal ablation (ASA) is an effective and minimally invasive therapeutic strategy to resolve left ventricular outflow tract obstruction (LVOTO) in patients with hypertrophic cardiomyopathy who remain symptomatic on maximally tolerated medical therapy. First performed by Sigwart in 1994, the procedure consists in determining an iatrogenic infarction of the basal interventricular septum to reduce LVOTO and alleviate symptoms. Since its first description, numerous studies have demonstrated its efficacy and safety, proposing ASA as a valid and attractive alternative to surgical septal myectomy. The success rate of the intervention is profoundly affected by patient selection and centre experience. In this review, we sought to summarise current evidence on ASA, describing the procedure and proposing a cardiomyopathy team-based approach to resolve clinical disputes in clinical practice.



EuroIntervention: 28 Aug 2019; 15:411-417
Pelliccia F, Niccoli G, Gragnano F, Limongelli G, ... Elliott P, Calabrò P
EuroIntervention: 28 Aug 2019; 15:411-417 | PMID: 30860070
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Impact:
Abstract

Influence of target vessel on prognostic relevance of fractional flow reserve after coronary stenting.

Hwang D, Lee JM, Lee HJ, Kim SH, ... Doh JH, Koo BK
Aims
We sought to investigate the influence of the target vessel on the prognostic relevance of fractional flow reserve (FFR) after percutaneous coronary intervention (PCI).
Methods and results
A total of 835 patients with available FFR after second-generation drug-eluting stent (DES) implantation were included in this study. The primary outcome was target-vessel failure (TVF), including cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularisation. The target vessel was the left anterior descending artery (LAD) in 603 patients (72.2%) and non-LAD in 232 patients (27.8%). The distribution pattern of post-PCI FFR values was different between the LAD and non-LAD (p<0.001). The optimal cut-off values of post-PCI FFR for predicting TVF were 0.82 and 0.88 in the LAD and non-LAD, respectively. The cumulative incidence of TVF was significantly higher in patients with lower post-PCI FFR than each cut-off value (10.9% vs. 2.5%, hazard ratio [HR] 4.08, 95% confidence interval [CI]: 2.63-6.34, p<0.001 in LAD; 8.0% vs. 1.9%, HR 6.00, 95% CI: 1.78-20.26, p=0.004 in non-LAD).
Conclusions
Higher post-PCI FFR after second-generation DES implantation was associated with better clinical outcomes. Different cut-off values of post-PCI FFR need to be applied according to the target vessel. ClinicalTrials Identifier: NCT01873560.



EuroIntervention: 28 Aug 2019; 15:457-464
Hwang D, Lee JM, Lee HJ, Kim SH, ... Doh JH, Koo BK
EuroIntervention: 28 Aug 2019; 15:457-464 | PMID: 30561367
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Impact:
Abstract

Pressure-bounded coronary flow reserve to assess the extent of microvascular dysfunction in patients with ST-elevation acute myocardial infarction.

Scarsini R, De Maria GL, Shanmuganathan M, Kotronias RA, ... Borlotti A, Dawkins S
Aims
Assessment of microvascular function in patients with ST-elevation acute myocardial infarction (STEMI) may be useful to determine treatment strategy. The possible role of pressure-bounded coronary flow reserve (pb-CFR) in this setting has not been determined.
Methods and results
Thermodilution-pressure-wire assessment of the infarct-related artery was performed in 148 STEMI patients before stenting and/or at completion of primary percutaneous coronary intervention (PPCI). The extent of the myocardial injury was assessed with cardiovascular magnetic resonance imaging at 48-hours and 6-months after STEMI. Post-PPCI pb-CFR was impaired (<2) and normal (>2) in 69.9% and 9.0% of the cases respectively. In the remaining 21.1% of the patients, pb-CFR was \"indeterminate\". In this cohort, pb-CFR correlated poorly with thermodilution-derived coronary flow reserve (k=0.03, p=0.39). The index of microcirculatory resistance (IMR) was significantly different across the pb-CFR subgroups. Similarly, significant differences were observed in microvascular obstruction (MVO), myocardium area-at-risk and 48-hours infarct-size (IS). A trend towards lower 6-month IS was observed in patients with high (>2) post-PPCI pb-CFR. Nevertheless, pb-CFR was inferior to IMR in predicting MVO and the extent of IS.
Conclusions
Pb-CFR can identify microvascular dysfunction in patients after STEMI and provided superior diagnostic performance compared to thermodilution-derived CFR in predicting MVO. However, IMR was superior to both pb-CFR and thermodilution-derived CFR and consequently, IMR was the most accurate in predicting all of the studied CMR endpoints of myocardial injury after PPCI.



EuroIntervention: 23 Dec 2019; epub ahead of print
Scarsini R, De Maria GL, Shanmuganathan M, Kotronias RA, ... Borlotti A, Dawkins S
EuroIntervention: 23 Dec 2019; epub ahead of print | PMID: 31854300
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Impact:
Abstract

The Changing Landscape of Aortic Valve Replacement in the United States.

Gupta T, Kolte D, Khera S, Goel K, ... Weisz G, Bhatt DL

With the growing utilization of TAVR over the last decade, it is important to examine the impact of adoption of TAVR on the number of SAVRs and total number of AVRs. We observed a linear increase in the total number of AVRs performed in the United States that was mainly driven by a marked diffusion of TAVR, whereas the number of SAVRs remained relatively stable. The number of TAVRs increased in all age categories. In contrast, the number of SAVRs increased modestly in those aged <75 years and declined in the older age categories. Our results highlight a previously untreated or undertreated population of patients that were not suitable candidates for surgery but are now being treated with TAVR.



EuroIntervention: 12 Aug 2019; epub ahead of print
Gupta T, Kolte D, Khera S, Goel K, ... Weisz G, Bhatt DL
EuroIntervention: 12 Aug 2019; epub ahead of print | PMID: 31403460
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Impact:
Abstract

Validation of the updated logistic clinical SYNTAX score for all-cause mortality in the GLOBAL LEADERS trial.

Chichareon P, Onuma Y, van Klaveren D, Modolo R, ... Windecker S, Serruys PW
Aims
The aim of this study was the external validation of the updated logistic clinical SYNTAX score for two-year all-cause mortality after PCI in the GLOBAL LEADERS trial.
Methods and results
The GLOBAL LEADERS trial was an investigator-initiated, prospective randomised, multicentre, open-label trial comparing two strategies of antiplatelet therapy in 15,991 patients undergoing PCI. As a predefined analysis, we studied the first 4,006 consecutive patients enrolled between July 2013 and April 2014 for whom the anatomic SYNTAX scores were calculated by an independent core lab. The updated logistic clinical SYNTAX score was available in 3,271 patients. Patients were divided into quintiles according to the score. The C-statistic of the updated logistic clinical SYNTAX score for two-year all-cause mortality was 0.71 (95% confidence interval [CI]: 0.64-0.77). The updated logistic clinical SYNTAX score identified patients at very high risk for two-year all-cause mortality after PCI. Although it systematically overestimated two-year all-cause mortality, predicted and observed two-year all-cause mortality in the majority of the patients (four out of five quintiles) were in agreement.
Conclusions
Overall discrimination for two-year all-cause mortality of the updated logistic clinical SYNTAX score is either borderline acceptable or possibly helpful. Calibration in the majority of patients is appropriate. The score is potentially useful in selecting enriched high-risk populations.



EuroIntervention: 08 Aug 2019; 15:e539-e546
Chichareon P, Onuma Y, van Klaveren D, Modolo R, ... Windecker S, Serruys PW
EuroIntervention: 08 Aug 2019; 15:e539-e546 | PMID: 31217143
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Impact:
Abstract

The MITRA-HR study: design and rationale of a randomised study of MitraClip transcatheter mitral valve repair in patients with severe primary mitral regurgitation eligible for high-risk surgery.

Piriou N, Al Habash O, Donal E, Senage T, ... Iung B, Guérin P
Aims
Percutaneous mitral valve repair has become an alternative to conventional surgery in patients suffering primary mitral regurgitation (MR) with a contraindication to surgery and could benefit patients at high surgical risk. The aim of the MITRA-HR study is to raise the level of evidence supporting the use of the MitraClip device in primary MR patients with a predefined high risk for surgery.
Methods and results
MITRA-HR is a prospective, multicentre, randomised study designed to compare mitral valve repair using the MitraClip with conventional surgery in patients with severe primary mitral regurgitation at high risk for surgery. The surgical risk is defined by age, Society of Thoracic Surgeons (STS) risk estimate score, frailty, major organ system dysfunction, and procedure-specific impediments. The study will enrol 330 patients randomised between conventional surgery and MitraClip with a 1:1 ratio. The composite primary endpoint includes all-cause mortality, unplanned rehospitalisation for cardiovascular reasons, and mitral valve reintervention at 12 months. The main secondary safety endpoint is a major adverse event composite assessment evaluated 30 days after the procedure.
Conclusions
The randomised MITRA-HR study is designed to provide additional supportive evidence of non-inferiority in efficacy and superiority in safety for percutaneous mitral valve repair using the MitraClip compared to conventional surgery in high surgical risk patients.



EuroIntervention: 19 Jul 2019; 15:e329-e335
Piriou N, Al Habash O, Donal E, Senage T, ... Iung B, Guérin P
EuroIntervention: 19 Jul 2019; 15:e329-e335 | PMID: 30987963
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Impact:
Abstract

Outcomes in nonagenarians undergoing transcatheter aortic valve implantation (TAVI): data from a nationwide analysis.

Deharo P, Bisson A, Herbert J, Lacour T, ... Cuisset T, Fauchier L
Aims
To describe the mid-term outcomes in nonagenarians undergoing transcatheter aortic valve implantation (TAVI).
Methods and results
Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients with aortic stenosis (AS), and specifically those treated with TAVI between 2010 and 2018. Cox regression was used for the analysis of predictors of events. We compared patients according to their age. Within the studied period, 71,095 patients older than 90 yo with AS were identified. After matching on baseline characteristics, TAVI was associated with lower rates of a combined outcome of all-cause death, rehospitalization for heart failure and stroke (Relative risk (RR) 0.58, p<0.001) in comparison with matched nonagenarians with AS treated medically. During follow-up (median 161, interquartile range 13-625), the combined outcome occurred more frequently in nonagenarians (RR 1.22, p<0.01) who had a TAVI than in younger patients undergoing this procedure. All cause death was reported in 17.6% vs. 14.5% of nonagenarians, rehospitalization for heart failure in 21.3% vs. 18.2% and stroke in 3.7% vs. 2.9% (p<0.01 for all parameters). We identified Charlson comorbidity index, heart failure, atrial fibrillation, stroke, vascular disease, cognitive impairment and denutrition as independent predictors of adverse outcomes in nonagenarians undergoing TAVI.
Conclusions
Within nonagenarians with AS, patients treated with TAVI had lower risk of cardiovascular events than matched patients treated medically. The patients undergoing a TAVI at this age were often highly selected and the procedure was associated with acceptable long term outcomes.



EuroIntervention: 25 Nov 2019; epub ahead of print
Deharo P, Bisson A, Herbert J, Lacour T, ... Cuisset T, Fauchier L
EuroIntervention: 25 Nov 2019; epub ahead of print | PMID: 31763981
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Impact:
Abstract

Interatrial shunting for heart failure: current evidence and future perspectives.

Guimaraes L, Lindenfeld J, Sandoval J, Bayés-Genis A, ... Provencher S, Rodés-Cabau J

The creation of an interatrial shunt in order to decompress the right or left atrium in patients with right and left ventricular failure, respectively, has been used as an alternative therapy to improve symptoms and clinical outcomes in patients with pulmonary hypertension-right heart failure and left heart failure refractory to optimal medical therapy. If ongoing randomised clinical trials further substantiate these beneficial effects in patients with chronic HF, interatrial shunting will represent an important new approach for treating this population.



EuroIntervention: 19 Jun 2019; 15:164-171
Guimaraes L, Lindenfeld J, Sandoval J, Bayés-Genis A, ... Provencher S, Rodés-Cabau J
EuroIntervention: 19 Jun 2019; 15:164-171 | PMID: 30803937
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Impact:
Abstract

Mid-term Procedural and Clinical Outcomes of Percutaneous Paravalvular Leak Closure With the Occlutech Paravalvular Leak Device.

Onorato EM, Muratori M, Smolka G, Zorinas A, ... Costante AM, Bartorelli AL
Aims
To assess the efficacy and safety of the Occlutech Paravalvular Leak Device (PLD) for the percutaneous closure of paravalvular leaks (PVL).
Methods and results
Patients with PVL were enrolled at 21 sites from 9 countries. Indications for PVL closure were heart failure and/or hemolytic anemia. Endpoint measures were changes in PV regurgitation grade, NYHA class and requirement for hemolysis-related transfusion. One-hundred thirty-six patients with mitral (67.6%) or aortic (32.4%) leaks were included (mean age 66.7 years, 58% men). Thirty-one percent had multiple PVLs. The proportion of patients with NYHA III/IV decreased from 77.3% at baseline to 16.9% at latest follow-up. The proportion of patients with need for hemolysis-related blood transfusion decreased from 36.8% to 5.9% and 8.3% to 0% for ML patients and AL patients, respectively. All cause mortality was 7.4%. Complications included interference with valve leaflets (0.7%), transient device embolization (percutaneously solved) (0.7%), late device embolization (0.7%), recurrent hemolytic anemia (2.2%), new onset hemolytic anemia (0.7%), valve surgery (2.2%), need for repeat closure (0.7%), complications at femoral puncture site (0.7%) and arrythmias requiring treatment (4.4%).
Conclusions
PVL closure with the Occlutech PLD demonstrated high success rate associated with significant clinical improvement and a relatively low rate of serious complications.



EuroIntervention: 19 Aug 2019; epub ahead of print
Onorato EM, Muratori M, Smolka G, Zorinas A, ... Costante AM, Bartorelli AL
EuroIntervention: 19 Aug 2019; epub ahead of print | PMID: 31422926
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Impact:
Abstract

Society of Thoracic Surgeons Risk Scores Performance in Patients with Left Main Coronary Artery Disease Undergoing Revascularization in the EXCEL trial.

Thuijs DJFM, Habib RH, Head SJ, Puskas JD, ... Sabik JF, Kappetein AP
Aims
Accurate risk prediction in patients undergoing revascularization is essential. We aimed to assess the predictive performance of Society for Thoracic Surgeons (STS) risk models in patients with left main coronary artery disease (LMCAD) undergoing coronary artery bypass grafting (CABG) or percutaneous coronary intervention with everolimus-eluting stents (PCI-EES).
Methods and results
The predictive performance of STS risk models for perioperative mortality, stroke and renal failure were evaluated for their discriminative ability (C statistic) and calibration (Hosmer-Lemeshow goodness-of-fit-test; χ2 and p-values) among patients with LMCAD undergoing PCI-EES (n=935) and CABG (n=923) from the randomized EXCEL trial. STS risk scores, in CABG patients, showed good discrimination for 30-day mortality and average discrimination for stroke (C statistics 0.730 and 0.629 respectively) with average calibration. For PCI, STS risk scores had no discrimination for mortality (C statistic 0.507), yet good discrimination (C statistic 0.751) and calibration for stroke. The predictive performance for renal failure was good for CABG (C statistic 0.82), yet poor for PCI (C statistic 0.59).
Conclusions
In selected patients with LMCAD from the EXCEL trial, STS risk models showed good predictive performance for CABG yet lacked predictive performance for PCI for perioperative mortality and renal failure. The STS stroke risk model was surprisingly more discriminating in PCI compared to CABG EXCEL patients. Improved and procedure-specific risk-prediction instruments are needed to accurately estimate adverse events after LMCAD revascularization by CABG and PCI.



EuroIntervention: 19 Aug 2019; epub ahead of print
Thuijs DJFM, Habib RH, Head SJ, Puskas JD, ... Sabik JF, Kappetein AP
EuroIntervention: 19 Aug 2019; epub ahead of print | PMID: 31422924
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Impact:
Abstract

Comparative Effectiveness Analysis of Percutaneous Coronary Intervention vs. Coronary Artery Bypass Grafting in Patients with Chronic Kidney Disease and Unprotected Left Main Coronary Artery Disease :Insights From a Large-Sized All-Comers Registry.

Kim DW, Om SY, Park MW, Park HW, ... Her SH, Park DW
Aims
Outcomes according to the status of renal insufficiency were not fully evaluated in left main coronary artery disease (LMCAD).
Methods and results
Among 4894 patients with LMCAD, renal insufficiency was graded according to the estimated glomerular filtration rate (eGFR). The primary outcome was major adverse cardiocerebrovascular event (MACCE), defined as death, myocardial infarction, stroke, or any revascularization. 3,824 (78%) had group 1 (eGFR ≥60 ml·min -1·1.73m2), 838 (17%) had group 2 (eGFR ≥ 30 and <60), and 232 (5%) had group 3 (eGFR <30). At 2 years, after adjustment, compared with group 1, the risk of MACCE was significantly higher in group 2 (hazard ratio [HR] 1.46, 95% confidence interval [CI] 1.18-1.79) and in group 3 (HR 3.39, 95% CI 2.61-4.40). Meanwhile, the P interaction for MACCE across groups was 0.20. The adjusted risk of MACCE was similar between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in group 1 or 2. However, PCI was associated with a significantly higher risk of MACCE compared to CABG (HR 1.88, 95% CI 1.08-3.25) in group 3.
Conclusions
The degree of renal insufficiency was proportionately associated with unfavorable outcomes in patients with LMCAD. In group 3, PCI was associated with a higher risk of MACCE compared with CABG. Also, the effect of PCI vs. CABG on MACCE was consistent, with PCI being associated less bleeding and CABG being associated with less repeat revascularization.



EuroIntervention: 05 Aug 2019; epub ahead of print
Kim DW, Om SY, Park MW, Park HW, ... Her SH, Park DW
EuroIntervention: 05 Aug 2019; epub ahead of print | PMID: 31380780
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Impact:
Abstract

Incidence and Predictors of Stent Thrombosis after Endovascular Revascularisation of the Superficial Femoral Artery.

Bradaric C, Koppara T, Müller A, Haller B, ... Laugwitz KL, Ibrahim T
Aims
To assess the incidence and predictors of superficial femoral artery (SFA) stent thrombosis (ST) in a large patient cohort.
Methods and results
984 stented SFA-lesions were retrospectively analysed in 717 patients. We observed an overall ST rate of 7.5% (74/984) while 14% occurred early within 30 days after stenting, 51% during the first year thereafter and 35% later than one year. The estimated 5-year probability of ST was 13.4% [95% confidence interval CI: 10.0% to 16.7%]. Significant predictors of ST were stent-length (hazard ratio HR: 1.09 [95% CI: 1.06 to1.11], p<0.001), lesion-length (HR: 1.10 [1.08 to 1.13], p<0.001) female gender (HR: 1.79 [1.12 to 2.86], p=0.015), chronic total occlusion (CTO) (HR: 4.21 [2.51 to 7.05], p<0.001), implantation of more than one stent (2 stents: HR:6.06 [3.35 to 11.0], p<0.001), (3 or more stents: HR:16.83 [9.43 to 30.0], p<0.001) as well as lesion complexity criteria as expressed by TASC-II C/D (HR: 17.7 [5.56 to 56.1], p<0.001).
Conclusions
ST after SFA stenting was a common adverse event in our cohort and peaked during the first year after stent implantation. Independent predictors of ST included lesion- and stent-length, female gender, presence of CTO, number of implanted stents and lesion complexity.



EuroIntervention: 29 Jul 2019; epub ahead of print
Bradaric C, Koppara T, Müller A, Haller B, ... Laugwitz KL, Ibrahim T
EuroIntervention: 29 Jul 2019; epub ahead of print | PMID: 31355753
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Impact:
Abstract

Prosthetic valve endocarditis after transcatheter or surgical aortic valve replacement with a bioprosthesis: results from the FinnValve Registry.

Moriyama N, Laakso T, Biancari F, Raivio P, ... Airaksinen J, Laine M
Aims
The aim of this study was to compare the risk of prosthetic valve endocarditis (PVE) in patients with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR).
Methods and results
The FinnValve registry included data from 6,463 consecutive patients who underwent TAVR (n=2,130) or SAVR (n=4,333) with a bioprosthesis from 2008 to 2017. PVE was defined according to the modified Duke criteria. In this study, the incidence of PVE was 3.4/1,000 person-years after TAVR, and 2.9/1,000 person-years after SAVR. In competing risk analysis there was no significant difference in the risk of PVE between patients with TAVR and SAVR over an eight-year observational period. Male gender (HR 1.73, 95% CI: 1.04-2.89) and deep sternal wound infection or vascular access-site infection (HR 5.45, 95% CI: 2.24-13.2) were positively associated with PVE, but not type of procedure (HR 1.09, 95% CI: 0.59-2.01) in multivariate analysis. The mortality rate was 37.7% at one month and increased to 52.5% at one year. Surgical treatment was independently associated with decreased in-hospital mortality (HR 0.34, 95% CI: 0.21-0.61).
Conclusions
PVE is rare, and its risk is similar after TAVR and SAVR. ClinicalTrials.gov Identifier: NCT03385915. https://clinicaltrials.gov/ct2/show/NCT03385915.



EuroIntervention: 08 Aug 2019; 15:e500-e507
Moriyama N, Laakso T, Biancari F, Raivio P, ... Airaksinen J, Laine M
EuroIntervention: 08 Aug 2019; 15:e500-e507 | PMID: 31113766
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Impact:
Abstract

Standard versus ultrasound-guided radial and femoral access in coronary angiography and intervention (SURF): a randomised controlled trial.

Nguyen P, Makris A, Hennessy A, Jayanti S, ... Leung M, Juergens C
Aims
This study aimed to compare outcomes in unselected patients undergoing cardiac catheterisation via transradial versus transfemoral access and standard versus ultrasound-guided arterial access.
Methods and results
This was a prospective, randomised (radial vs. femoral and standard vs. ultrasound), 2x2 factorial trial of 1,388 patients undergoing coronary angiography and percutaneous coronary intervention. The primary outcome was a composite of ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) major bleeding, MACE (death, stroke, myocardial infarction or urgent target lesion revascularisation) and vascular complications at 30 days. Transradial access reduced the primary outcome (RR 0.37, 95% CI: 0.17-0.81; p=0.013), mostly driven by ACUITY major bleeding (RR 0.343, 95% CI: 0.123-0.959; p=0.041) when compared with the transfemoral approach. There was no difference in the primary outcome between standard and ultrasound guidance (p=0.76). Ultrasound guidance, however, reduced mean access time (93 sec vs. 111 sec; p=0.009), attempts (1.47 vs. 1.9; p<0.0001), difficult accesses (4.5% vs. 9.2%; p=0.0007), venepuncture (4.1% vs. 9.2%; p<0.0001) and improved first-pass success (73% vs. 59.7%; p<0.0001).
Conclusions
Transradial access significantly reduced the composite outcome compared to transfemoral access. Ultrasound guidance did not reduce the primary outcome compared to the standard technique, but significantly improved the efficiency and overall success rate of arterial access.



EuroIntervention: 08 Aug 2019; 15:e522-e530
Nguyen P, Makris A, Hennessy A, Jayanti S, ... Leung M, Juergens C
EuroIntervention: 08 Aug 2019; 15:e522-e530 | PMID: 31113763
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Impact:
Abstract

Effect of Rosuvastatin and Eicosapentaenoic Acid on Neoatherosclerosis: The LINK-IT Trial.

Kuroda K, Otake H, Shinohara M, Kuroda M, ... Shinke T, Hirata KI
Aims
We assessed the effect of 10 mg/day of rosuvastatin plus eicosapentaenoic acid (EPA) versus 2.5 mg/day of rosuvastatin on the extent of neoatherosclerosis using optical coherence tomography (OCT).
Methods and results
We randomly assigned 50 patients with non-obstructive neoatherosclerotic plaques detected on OCT to receive either rosuvastatin 10 mg/day and EPA 1800 mg/day (intensive-therapy group) or rosuvastatin 2.5 mg (standard-therapy group). Follow-up OCT was performed 1 year later to evaluate serial changes of neoatherosclerosis. Serum low-density lipoprotein cholesterol (LDL-C) level decreased significantly from baseline to the 12-month follow-up in the intensive-therapy group (89 mg/dL to 70 mg/dL; P < 0.001), while no change occurred in the standard-therapy group. Lipid index change and percent changes in macrophage grade were significantly lower in the intensive-therapy group than in the standard-therapy group (-53.6 vs. 310.1, P = 0.001; -37.0% vs. 35.3%, P < 0.001; respectively). Percent changes in lipid index and macrophage grade were positively correlated with the changes in serum LDL-C and C-reactive protein levels, and negatively correlated with the change in serum eicosapentaenoic acid/arachidonic acid and 18-hydroxyeicosapentaenoic acid (EPA bioactive metabolite) level.
Conclusions
Compared with rosuvastatin 2.5 mg/day, rosuvastatin 10 mg/day and EPA 1800 mg/day significantly stabilized non-obstructive neoatherosclerotic plaques.



EuroIntervention: 22 Jul 2019; epub ahead of print
Kuroda K, Otake H, Shinohara M, Kuroda M, ... Shinke T, Hirata KI
EuroIntervention: 22 Jul 2019; epub ahead of print | PMID: 31334703
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Impact:
Abstract

Retrograde approach for the percutaneous recanalisation of coronary chronic total occlusions: contribution to clinical practice and long-term outcomes.

Kwon O, Lee PH, Lee SW, Lee JY, ... Park SW, Park SJ
Aims
We aimed to evaluate the contribution of the retrograde approach to real-world practice over time and its long-term outcomes in chronic total occlusion (CTO) percutaneous coronary intervention (PCI).
Methods and results
We evaluated 1,635 CTO procedures conducted at our high-volume centre between 2003 and 2015. The retrograde approach has been actively adopted in practice since January 2007. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularisation/reocclusion. The technical success rate of CTO-PCI has increased from 79.5% to 87.1% since 2007, although the complexity of the CTOs has also significantly increased in that time (J-CTO scores: from 1.8±1.2 to 2.0±1.1, p=0.03). The incidence of in-hospital MACCE using the retrograde approach was 4.5%, which was comparable to the antegrade-only approach rate of 4.1% (p=0.58). The retrograde approach showed a higher four-year TVF rate after successful stenting compared with the antegrade-only approach (17.1% vs 9.4%, p=0.01), but this difference was mainly driven by a higher target vessel revascularisation/reocclusion rate. Multivariable analysis revealed that renal dysfunction (hazard ratio [HR] 3.33, 95% confidence interval [CI]: 1.42-7.83), acute coronary syndrome (HR 1.99, 95% CI: 1.26-3.14), the J-CTO score (per 1, HR 1.23, 95% CI: 1.00-1.51), and the smallest stent diameter (per 1 mm, HR 0.39, 95% CI: 0.21-0.74) (all p<0.05) were independently associated with TVF.
Conclusions
A retrograde approach contributes to the increased success of more complex CTO-PCI over time with an acceptable frequency of in-hospital complications and four-year TVF rate.



EuroIntervention: 19 Jul 2019; 15:e354-e361
Kwon O, Lee PH, Lee SW, Lee JY, ... Park SW, Park SJ
EuroIntervention: 19 Jul 2019; 15:e354-e361 | PMID: 30375334
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Impact:
Abstract

Graft patency after FFR-guided versus angiography-guided coronary artery bypass grafting. The GRAFFITI trial.

Toth GG, De Bruyne B, Kala P, Ribichini FL, ... Degriek I, Barbato E
Aims
To prospectively assess clinical benefits of fractional flow reserve (FFR) in guiding coronary artery bypass grafting (CABG).
Methods and results
GRAFFITI is a single-blinded prospective multicenter randomized controlled trial for FFR-guided versus angiography-guided CABG. We enrolled patients, undergoing coronary angiography, having significantly diseased left anterior descending or left main stem and at least one more major coronary artery with intermediate stenosis, assessed by FFR. Surgical strategy was defined based on angiogram, blinded to FFR values prior to randomization. After randomization, patients were either operated following the angiogram-based strategy (Angiography-guided group) or according to FFR: i.e. with FFR≤0.80 as cut-off for grafting (FFR-guided group). Primary endpoint was graft patency at 12 months. Trial was registered (NCT01810224). Between March 2012 and December 2016, 172 patients were randomized either to angiography-guided (84 patients) or to FFR-guided group (88 patients). Patients had median of 3 [3;4] lesions. Diameter stenosis was 65% [50%;80%], FFR was 0.72 [0.50;0.82]. Compared to angiography-guided group, FFR-guided group received less anastomoses (3 [3;3] vs. 2 [2;3] respectively; p=0.004). One-year angiographic follow-up showed no difference in overall graft patency (126 [80%] vs 113 [81%], respectively; p=0.885). One-year clinical follow-up, available in 98% of patients, showed no difference in composite of death, myocardial infarction, target vessel revascularization and stroke.
Conclusions
FFR-guidance of CABG has no impact on 1-year graft patency, but it is associated with a simplified surgical procedure.



EuroIntervention: 01 Jul 2019; epub ahead of print
Toth GG, De Bruyne B, Kala P, Ribichini FL, ... Degriek I, Barbato E
EuroIntervention: 01 Jul 2019; epub ahead of print | PMID: 31270037
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Impact:
Abstract

Long term follow-up of patients with aortic arch atresia post recanalization.

Chessa M, Favoccia C, Jha NK, Carminati M, ... Tofeig M, Khan MD
Aims
Aortic arch atresia (AAA) is one of the rarest obstructive defects. Presence of this anomaly in adult age is also uncommon. The typical anatomic feature consists of a complete occlusion of the membranous obstruction resulting in an acquired atresia without flow continuity between proximal and distal segments. This feature is important in determining the feasibility of percutaneous intervention. We present a long term follow up of 19 patients with \'AAA\' who underwent successful percutaneous recanalization with covered stents.
Methods and results
Retrospective data of 19 patients (12 male, 63.2%, mean age: 32.2 years ± 18.9 years) diagnosed with \'AAA\' treated in five different centers between 1999 to 2017 were collected. All patients underwent percutaneous recanalization by (1) radiofrequency system (RF) (five patients, 26.3%), (2) extra-stiff guide wire (12 patients, 63.2%) and (3) trans-septal needle (two patients, 10.5%). All procedures were subsequently followed by covered stent implantation. Two patients developed complications during the procedure and one of them died. Over a median follow-up of 4.94 years, four (21%) patients were able to wean medications for hypertension. All the patients underwent reassessment for recurrence or restenosis during the follow up. Seven (36.8%) patients underwent successful stent dilatation with a balloon. After the intervention, one patient experienced a late complication, however, one patient died due to an unknown cause believed to be unrelated to the previous recanalization procedure.
Conclusions
Percutaneous treatment of \'AAA\' is feasible with good long-term survival. This study reports the largest case series as per available literature, so far.



EuroIntervention: 24 Jun 2019; epub ahead of print
Chessa M, Favoccia C, Jha NK, Carminati M, ... Tofeig M, Khan MD
EuroIntervention: 24 Jun 2019; epub ahead of print | PMID: 31235456
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Impact:
Abstract

In-Stent Restenosis Lesion Morphology Related to Repeat Stenting Underexpansion as Evaluated by Optical Coherence Tomography.

Yin D, Mintz GS, Song L, Chen Z, ... Sosa FA, Haag ES
Aims
To use optical coherence tomography (OCT) to predict newly implanted stent expansion for treatment of in-stent restenosis (ISR).
Methods and results
With OCT-guidance, 143 ISR lesions were treated with a new stent. Stent underexpansion was defined as minimum stent area (MSA) <4.5mm 2 and MSA/average of reference lumen area <70%. New stent underexpansion was found in 33 lesions (23%), had a smaller old stent MSA (4.13 [3.32-4.62] versus 5.18 [4.01-6.38] mm 2 , p=0.001), and had a higher prevalence of multiple old stent layers (51.5% versus 10.9%, p<0.001) and neointimal or peri-stent calcium (69.7% versus 37.3%, p=0.001) compared to those without new stent underexpansion. Old stent underexpansion, multiple layers of old stent, maximum calcium angle >180°, and maximum calcium thickness >0.5mm were independently associated with new stent underexpansion. Patients with new stent underexpansion had a higher prevalence of major adverse cardiac events (35.5% vs 14.3%, p=0.009) mainly driven by a higher rate of myocardial infarction and target vessel revascularization at 2 years.
Conclusions
When re-stenting an ISR lesion, old stent underexpansion, the amount of neointimal or peri-stent calcium, and multiple old stent strut layers are important determinants of new stent underexpansion that is then associated with adverse long-term outcomes.



EuroIntervention: 12 Aug 2019; epub ahead of print
Yin D, Mintz GS, Song L, Chen Z, ... Sosa FA, Haag ES
EuroIntervention: 12 Aug 2019; epub ahead of print | PMID: 31403461
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Impact:
Abstract

Association of Coronary Microvascular Endothelial Dysfunction with Vulnerable Plaque Characteristics in Early Coronary Atherosclerosis.

Godo S, Corban MT, Toya T, Gulati R, Lerman LO, Lerman A
Aims
To test the hypothesis that coronary microvascular endothelial dysfunction (CMED) is associated with epicardial coronary atherosclerosis.
Methods and results
We performed a cross-sectional analysis of a comprehensive invasive assessment of coronary physiology with a focus on endothelium-dependent coronary microvascular function and virtual-histology intravascular ultrasound (VH-IVUS) in a total of 148 consecutive patients with chest pain and angiographically normal coronary arteries or nonobstructive coronary artery disease (CAD). Endothelium-dependent coronary vascular reactivity was evaluated by graded doses of intracoronary acetylcholine (ACh). CMED was defined as percent increase in coronary blood flow of ≤50% in response to ACh. Patients with CMED (n = 87) showed more vulnerable plaque characteristics as compared to those without (n = 61); they showed higher plaque burden in association with larger necrotic core volume and higher frequency of imaged arteries containing at least one VH-IVUS-derived thin-capped fibroatheroma (TCFA) [n = 22 (25.3%) vs. 5 (8.2%), P = 0.008]. Multivariate logistic regression analysis revealed that CMED was an independent predictor of VH-IVUS-derived TCFA [adjusted odds ratio 2.28 (95% confidence interval 1.30 - 4.02), P = 0.004] Conclusions: Independently of conventional coronary risk factors, CMED was associated with vulnerable plaque characteristics in patients with nonobstructive CAD.



EuroIntervention: 12 Aug 2019; epub ahead of print
Godo S, Corban MT, Toya T, Gulati R, Lerman LO, Lerman A
EuroIntervention: 12 Aug 2019; epub ahead of print | PMID: 31403459
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Impact:
Abstract

Preclinical evaluation of a transcatheter aortic valve replacement system for patients with rheumatic heart disease.

Scherman J, Ofoegbu C, Myburgh A, Swanevelder J, ... Bezuidenhout D, Zilla P
Aims
Cardiac surgery in middle-income countries differs significantly from that in high-income countries regarding prevailing heart valve pathologies and access to cardiac surgery. Typically, rheumatic aortic regurgitation in the absence of calcification by far outweighs stenosis. As such entirely different trans-catheter aortic valve (TAVI) concepts are required for these regions.
Methods and results
A self-homing, non-occlusive balloon-expandable TAVI system comprising a hollow-balloon, stabilizing locator-trunks, a scalloped CoCr-stent with elevating anchorage-arms and decellularized, sandwich-crosslinked pericardium was compared with control surgical valves (Edwards Perimount) in sheep. The implantation period was five months. The tactile placement of the TAVI valves was accomplished without the need for rapid pacing. At termination, no structural degeneration was observed in either groups. TAVIs were well-healed with the stent-struts largely embedded in tissue. Correlating with sheep-growth (weight gain of 40.4±13.0%) during the implantation period, mean transvalvular gradients increased from 3.08±1.95mmHg to 8.50±5.38mmHg (p=0.044) after 5 months.
Conclusions
A single-stage, balloon-expandable, easy-to-place TAVI system with antigen-depleted and antigen-masked bioprosthetic leaflets promises to address the distinct needs of low and middle-income countries in regard to TAVI better than conventional systems.



EuroIntervention: 12 Aug 2019; epub ahead of print
Scherman J, Ofoegbu C, Myburgh A, Swanevelder J, ... Bezuidenhout D, Zilla P
EuroIntervention: 12 Aug 2019; epub ahead of print | PMID: 31403458
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Impact:
Abstract

Transcatheter therapy for residual mitral regurgitation after MitraClip therapy.

Niikura H, Bae R, Gössl M, Lin D, Jay D, Sorajja P
Aims
We aimed to examine the effectiveness and the optimal technique for transcatheter therapy for residual mitral regurgitation (MR) after MitraClip therapy with the AMPLATZER Vascular Plug II (AVP-II).
Methods and results
Nine patients (mean age, 78±4 years) underwent transcatheter therapy with the AVP-II for residual MR after MitraClip therapy. We examined procedural, in-hospital, and 30-day outcomes. Our technique was successful in all cases, with treatment of different types of residual MR, including paraclip, interclip, and leaflet perforation. MR grade decreased significantly from 4+ to 1+ (p<0.0001), with final residual MR being mild or none in seven patients. Mitral stenosis did not occur with plug placement. The optimal deployment technique for reduction of MR was placement with only one segment on the left atrial side of the mitral valve leaflets (n=8). During clinical follow-up (median 155 days), symptom improvement had occurred in all patients (NYHA class, baseline vs follow-up, 3.2±0.4 vs 2.3±0.8; p=0.01) with mild or no symptoms in six patients. There was no procedural mortality, major adverse event(s), device embolisation, haemolysis or need for cardiac surgery.
Conclusions
For patients with residual MR after MitraClip therapy, this technique may be effective and safe, especially when deployed with only one segment on the left atrial side of the mitral leaflets.



EuroIntervention: 08 Aug 2019; 15:e491-e499
Niikura H, Bae R, Gössl M, Lin D, Jay D, Sorajja P
EuroIntervention: 08 Aug 2019; 15:e491-e499 | PMID: 31217145
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Impact:
Abstract

Ultrasound-guided access of the distal radial artery at the anatomical snuffbox for catheter-based vascular interventions: A technical guide.

Hadjivassiliou A, Kiemeneij F, Nathan S, Klass D

Conventional radial access has been shown to have many advantages over transfemoral approach. The risk of potential radial artery occlusion and subsequent hand ischaemia can be reduced further by accessing the vessel distally at the anatomical snuffbox, allowing for maintenance of antegrade flow to the hand by the superficial palmar arch branch. Additional potential advantages of distal radial access in comparison to the conventional radial approach at the wrist include fewer puncture site complications and faster post-procedural haemostasis as the vessel is very superficial. Furthermore, it provides another safe, non-femoral option for vascular access. The use of ultrasound guidance enables the operator to identify important anatomical landmarks and avoid injuring adjacent structures. We provide a detailed step-by-step guide for performing distal radial access using sonographic and anatomical correlation thereby facilitating safe access and optimising technical success.



EuroIntervention: 05 Aug 2019; epub ahead of print
Hadjivassiliou A, Kiemeneij F, Nathan S, Klass D
EuroIntervention: 05 Aug 2019; epub ahead of print | PMID: 31380781
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Impact:
Abstract

Does an occluded RCA affect prognosis in patients undergoing PCI or CABG for left main coronary artery disease? Analysis from the EXCEL trial.

Chen S, Karmpaliotis D, Redfors B, Shlofmitz E, ... Kappetein AP, Stone GW
Aims
The impact of an occluded right coronary artery (RCA) in patients with left main coronary artery disease (LMCAD) undergoing revascularisation is unknown. We compared outcomes for patients with LMCAD randomised to percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) according to the presence of an occluded RCA in the EXCEL trial.
Methods and results
The EXCEL trial randomised 1,905 patients with LMCAD and SYNTAX scores ≤32 to PCI with everolimus-eluting stents versus CABG. Patients were categorised according to whether they had an occluded RCA at baseline, and their outcomes were examined using multivariable Cox proportional hazards regression. The primary endpoint was a composite of death, stroke, or myocardial infarction at three years. Among 1,753 patients with a dominant RCA by core laboratory analysis, the RCA was occluded in 130 (7.4%) at baseline. PCI was attempted in 34 of 65 patients with an occluded RCA (52.3%) and was successful in 27 (79.4% of those attempted; 41.5% of all RCAs recanalised). The RCA was bypassed in 42 of 65 patients with an occluded RCA (64.6%; p=0.0008 versus PCI). The three-year absolute and relative rates of the primary endpoint were similar between PCI and CABG, in patients with or without an occluded RCA (pinteraction=0.92).
Conclusions
In the EXCEL trial, the presence of an occluded RCA at baseline did not confer a worse three-year prognosis in patients undergoing revascularisation for LMCAD and did not affect the relative outcomes of PCI versus CABG in this high-risk patient cohort.



EuroIntervention: 08 Aug 2019; 15:e531-e538
Chen S, Karmpaliotis D, Redfors B, Shlofmitz E, ... Kappetein AP, Stone GW
EuroIntervention: 08 Aug 2019; 15:e531-e538 | PMID: 31186220
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Impact:
Abstract

Thromboresistance and functional healing in the COBRA PzF stent versus competitor DES: implications for dual antiplatelet therapy.

Jinnouchi H, Mori H, Cheng Q, Kutyna M, ... Virmani R, Finn AV
Aims
The aim of this study was to investigate the COBRA PzF stent (C-PzF) with respect to thrombogenicity and healing versus conventional drug-eluting stents (DES) in dedicated preclinical models to evaluate their suitability for short-term dual antiplatelet therapy (DAPT).
Methods and results
To examine acute thrombogenicity, the C-PzF durable polymer drug-eluting stent (DP-DES), and a bioabsorable polymer DES (BP-DES) were compared in a porcine arteriovenous shunt model and in a rabbit model to evaluate endothelial coverage at 14 days. Barrier function at 28 days in the rabbit was assessed in the former stents as well as in a polymer-free DES (PF-BES). The number of clots by scanning electron microscopy (SEM) was significantly less in the C-PzF and DP-EES versus the BP-EES. Endothelial coverage at 14 days was significantly greater in the C-PzF versus the DP-EES and BP-EES by CD31/PECAM-1 positive area in confocal microscopy (CM) (24.7% vs 11.9% vs 3.7%, respectively) and SEM (99.0% vs 29.6% vs 17.7%, respectively). Barrier protein expression by CM for p120/vascular-endothelial cadherin complex was significantly greater in the C-PzF versus the DP-EES, BP-EES, and PF-BES (82.6% vs 12.8% vs 14.4% vs 18.1%, respectively). The percentage of Evan\'s Blue positive area was least in the C-PzF versus all groups (22.0% vs 70.7% vs 66.4% vs 55.2%, respectively).
Conclusions
The C-PzF demonstrated a unique combination of thrombogenicity and healing advantages compared to contemporary DES and may be uniquely suitable for very short-term DAPT.



EuroIntervention: 19 Jul 2019; 15:e342-e353
Jinnouchi H, Mori H, Cheng Q, Kutyna M, ... Virmani R, Finn AV
EuroIntervention: 19 Jul 2019; 15:e342-e353 | PMID: 30375338
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Impact:
Abstract

First-in-man randomized comparison of the Angiolite® durable fluoro-acrylate polymer-based sirolimus-eluting stent versus durable fluoropolymer-based everolimus eluting stent in patients with coronary artery disease: The ANGIOLITE trial.

Moreu J, Moreno-Gómez R, Pérez de Prado A, García Del Blanco B, ... Díaz-Fernández JF, Amat I
Aims
The durable fluoro-acrylate polymer-based sirolimus-eluting stent (Angiolite®SES) has shown promising preclinical and clinical results regarding inflammatory vascular reaction and neointimal healing. We aimed to compare performance between SES and everolimus-eluting (EES) stents in patients with coronary artery disease.
Methods and results
The ANGIOLITE trial, a prospective, randomized, multicenter trial, compared the restenosis parameters of both stents in de novo coronary lesions. Primary endpoint was late lumen loss at 6-month angiographic follow-up. In-stent healing was assessed by optical coherence tomography (OCT). Main clinical endpoint was target lesion failure (TLF) evaluated up to 24 months. A total of 223 patients were randomized 1:1 to EES or SES. At 6 months, in-stent late lumen loss was 0.08 mm (±0.38) for EES vs 0.04 mm (±0.39) for SES (Difference=-0.04 mm 95%CI [-0.15, 0.07], p for non-inferiority=0.002). By OCT, rate of uncovered to total number of struts score >30% was comparable between groups whereas neointimal thickness was reduced in the SES arm (9.0% [7.6, 10.6] vs. 9.9% [8.5, 11.3], p=0.41; and 86.4 [81.6, 91.2] µm vs 72.1 [68.2, 76.0] µm; p<0.01, respectively). At 24 months, TLF occurred in 8 patients (7.6% [3.3, 14.5]) in EES arm and in 7 patients (7.1% [2.9, 14.0]) in SES arm (p=0.88). Definite/probable stent thrombosis rate was comparable between groups (1.9% [0.2, 6.7] vs 1.0% [0.0, 5.5] EES vs. SES, respectively; p=0.59).
Conclusions
This trial demonstrates similar anti-restenotic efficacy at mid-term follow-up of the Angiolite®SES vs. EES. Clinical endpoints were comparable between groups at 2-year follow-up.



EuroIntervention: 15 Jul 2019; epub ahead of print
Moreu J, Moreno-Gómez R, Pérez de Prado A, García Del Blanco B, ... Díaz-Fernández JF, Amat I
EuroIntervention: 15 Jul 2019; epub ahead of print | PMID: 31310239
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Abstract

Prospective concurrent head-to head comparison of three different types of nitinol occluder device for transcatheter closure of secundum atrial septal defects.

Bhattacharjya S, Pillai LS, Doraiswamy V, Satyanarayana RM, ... Pavithran S, Sivakumar K
Aims
Previous comparisons between AMPLATZER septal occluders and other designs were retrospective, non-randomised, non-concurrent and involved fewer patients. A prospective concurrent head-to-head comparison of AMPLATZER (ASO), Cera (CSO) and Figulla (FSO) septal occluders was planned to study the patient outcomes.
Methods and results
The three occluders were serially allocated in a cycle of three to consecutively included patients. Demographic, procedural details and complications were analysed. After calculating a sample size of 122 patients in each group, additional patients were recruited to ensure at least 80% follow-up. Four hundred and fifty (450) consecutive patients equally divided among the three designs were comparable in all parameters. There were no major complications and procedural success was 99.6%. The defects and device sizes were similar in all groups; the delivery system was significantly smaller with the ASO. The FSO needed special deployment techniques less often and formed a cobra deformity more often, though this was not statistically significant. Patient outcome was similar among the groups at a follow-up of 12-47 months.
Conclusions
The new occluders are comparable to the ASO with good outcomes and low complication rates in the current era. The new modified structural designs do not show any advantages in terms of procedural complications on early and midterm follow-up, but long-term studies are warranted.



EuroIntervention: 19 Jul 2019; 15:e321-e328
Bhattacharjya S, Pillai LS, Doraiswamy V, Satyanarayana RM, ... Pavithran S, Sivakumar K
EuroIntervention: 19 Jul 2019; 15:e321-e328 | PMID: 30946015
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Abstract

A Continuous Intracoronary Versus A Standard Intravenous Infusion of Adenosine for Fractional Flow Reserve Assessment - the HYPEREMIC Trial.

Elghamaz A, Myat A, de Belder A, Collison D, ... Stone GW, Oldroyd K
Aims
To evaluate the accuracy of a continuous intracoronary (IC) adenosine infusion, administered through a novel HYPEREM â„¢ IC over-the-wire microcatheter, to measure fractional flow reserve (FFR).
Methods and results
The HYPEREMIC trial was a randomised, non-inferiority, crossover study in which patients with intermediate coronary lesions were enrolled for sequential pressure wire studies. FFR was measured using intravenous (IV) (140-180 mcg/kg/min) versus continuous non-weight-adjusted IC (360 mcg/min) adenosine. Patients were randomised and blinded to the order in which they received the adenosine, separated by a washout period. The primary endpoint was the mean hyperaemic FFR. Forty-one patients were enrolled at 3 UK sites between June and November 2016. The mean (standard deviation) FFR was 0.82 (±0.09) after IC versus 0.84 (±0.09) after IV adenosine. The difference of -0.02 (95% confidence interval [CI] -0.03 to -0.01) confirmed non-inferiority (margin <0.05) of IC to IV adenosine. Intracoronary adenosine was associated with a shorter mean time to maximal hyperaemia (difference -44 [95% CI -59 to -29] seconds; p<0.0001). Chest discomfort was reported in 32/41 (78.0%) patients during IV adenosine versus 12/41 (29.3%) patients during IC adenosine.
Conclusions
Continuous IC adenosine was a reliable, faster and better-tolerated method of achieving maximal hyperaemia compared to IV adenosine.



EuroIntervention: 08 Jul 2019; epub ahead of print
Elghamaz A, Myat A, de Belder A, Collison D, ... Stone GW, Oldroyd K
EuroIntervention: 08 Jul 2019; epub ahead of print | PMID: 31289017
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Abstract

Preclinical evaluation of a thin-strut bioresorbable scaffold (ArterioSorb): acute-phase invasive imaging assessment and hemodynamic implication.

Katagiri Y, Torii R, Takahashi K, Tenekecioglu E, ... Serruys PW, Onuma Y
Aims
To assess acute performance of the 95-µm ArterioSorb oriented poly L-lactic acid (PLLA) scaffold in comparison with the Xience metallic drug-eluting stent (DES) in porcine coronary arteries.
Methods and results
In 15 nonatherosclerotic Yucatan mini pigs, ArterioSorb in 3.0/14 mm and Xience in 3.0/15 mm were implanted in 25 and 15 vessels, respectively. Acute performance was evaluated by using quantitative coronary angiography (QCA) and optical coherence tomography (OCT). Following three-dimensional reconstruction of coronary arteries, endothelial shear stress (ESS) was quantified using non-Newtonian steady-flow simulation. Acute recoil measured by QCA was comparable in the two arms. Post-procedural flow and scaffold/stent area by OCT did not differ between the two devices. ESS post-procedure was comparable between ArterioSorb and Xience (2.21±1.97 vs. 2.25±1.71 Pa, p=0.314).
Conclusions
Acute recoil, luminal dimensions and ESS in ArterioSorb oriented-PLLA scaffold with thin struts of 95 µm were comparable to Xience metallic DES.



EuroIntervention: 08 Jul 2019; epub ahead of print
Katagiri Y, Torii R, Takahashi K, Tenekecioglu E, ... Serruys PW, Onuma Y
EuroIntervention: 08 Jul 2019; epub ahead of print | PMID: 31289016
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Abstract

Multi-center propensity-matched comparison of transcatheter aortic valve implantation using the ACURATE TA/neo self-expanding versus the SAPIEN 3 balloon-expanding prosthesis.

Barth S, Reents W, Zacher M, Kerber S, ... Hamm C, Hamm K
Aims
In the absence of randomized data, we aimed to compare the transapical ACURATE and transfemoral ACURATE neo with the SAPIEN 3 prostheses using propensity-matching.
Methods and results
From 2012 to 2016, 1306 patients at 3 German centers received either the ACURATE/ACURATE neo prostheses (n=591) or the SAPIEN 3 prosthesis (n=715). Through nearest neighborhood matching with exact allocation for access route and center, pairs of 329 patients (250 transfemoral, 79 transapical) per group were determined. Patients were 81 years in average and had a logistic EuroSCORE-I of 19%. Pre- and post-dilatation was more frequent in the ACURATE group (97.6% versus 52.1%, p<0.001 for pre-dilatation and 40.4% versus 11.6%, p<0.001 for post-dilation), but rapid pacing for implantation was used less frequently (37.1% versus 98.2%, p<0.001). More than mild aortic regurgitation at post-operative echocardiography was 12.0% for the ACURATE group and 3.1% for the SAPIEN group, p=<0.001), thereby more than mild aortic regurgitation in the ACURATE group differed amongst the centers with 6.0% (3/50) in center 1, 34.1% (29/85) in center 2 and 3.4% (6/181) in center 3. Patients in the ACURATE group had less pacemaker compared to SAPIEN 3 (11.9% versus 18.5%, p=0.020), 30-day mortality was 4.6% versus 2.1% respectively, p=0.134 and one year- survival was 83.1% [95%CI:77.6-87.4] versus 88.8% [84.0-92.2].
Conclusions
In this propensity score analysis, patients treated with the transapical ACURATE or transfemoral ACURATE neo prostheses had less pacemakers at 30 days, but more aortic regurgitation and lower 1 year survival.



EuroIntervention: 01 Jul 2019; epub ahead of print
Barth S, Reents W, Zacher M, Kerber S, ... Hamm C, Hamm K
EuroIntervention: 01 Jul 2019; epub ahead of print | PMID: 31270034
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Abstract

Characterization of a novel percutaneous closed chest swine model of ischemic mitral regurgitation guided by contrast echocardiography.

Hamza O, Kiss A, Kramer AM, Tillmann KE, Podesser BK
Introduction
Alternative approaches for mitral valve repair are being constantly developed. Even though the safety of these devices has been extensively assessed in healthy animals before approval for first-in-man studies, often the efficacy of these new devices has been hardly challenged in vivoin the setting of MR. Therefore, reliable and reproducible preclinical animal models of MR are crucial to allow not only the safety assessment but also the efficacy evaluation of these novel approaches.



EuroIntervention: 24 Jun 2019; epub ahead of print
Hamza O, Kiss A, Kramer AM, Tillmann KE, Podesser BK
EuroIntervention: 24 Jun 2019; epub ahead of print | PMID: 31235459
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Abstract

A Randomized, Intercontinental, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Stent in the Treatment of Subjects with de novo Coronary Artery Lesions BIOFLOW IV - Primary Outcome Target Vessel Failure at 12 Months.

Saito S, Tölg R, Witzenbichler B, Haude M, ... Waksman R, Slagboom T
Aims
The BIOFLOW-IV clinical trial was designed for regulatory submission in Japan. It assessed the safety and efficacy of a new third generation sirolimus-eluting stent system with bioresorbable polymer (Orsiro, BP-SES) compared with an everolimus-eluting stent system with permanent polymer (Xience Prime/Xpedition, PP-EES).
Methods and results
This prospective, international, multicenter, 2:1 randomized, non-inferiority trial enrolled 575 patients (385 BP-SES and 190 PP-EES) with 659 stenotic de novo lesions. Of these, 137 patients (23.8%) were Japanese. Follow-up until 5 years is ongoing, we herein report outcomes at 12 months. Baseline parameters were well balanced. Device success was 98.9% for BP-SES versus 99.6% for PP-EES, p=0.670. Non-inferiority related to 12-month target vessel failure was met (pnon-inferiority<0.001). Further, there was no significant difference in clinical outcomes between the groups. Target vessel failure rate was 5.5% for BP-SES and 7.5% for PP-EES, target lesion failure rate was 4.2% versus 5.4%, and the definite or probable stent thrombosis rate was 0.8% versus 0%.
Conclusion
The randomized BIOFLOW-IV trial provides further evidence on the safety and efficacy of the Orsiro BP-SES and its non-inferiority to the current benchmark, an everolimus-eluting permanent polymer stent.



EuroIntervention: 24 Jun 2019; epub ahead of print
Saito S, Tölg R, Witzenbichler B, Haude M, ... Waksman R, Slagboom T
EuroIntervention: 24 Jun 2019; epub ahead of print | PMID: 31235458
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Abstract

An Observational Study assessing the value of Computed Tomography Cardiac Angiography (CTCA) in planning invasive angiographic procedures in patients with previous coronary artery bypass grafting (CABG).

Jones DA, Castle EV, Beirne AM, Rathod KS, ... Pugliese F, Mathur A
Aims
Invasive Coronary angiography (ICA) is more complex and challenging in patients with previous CABG. Computerised Tomography Coronary Angiography (CTCA) may provide useful information prior to ICA to improve these procedures.
Methods and results
This single-centre observational study included 835 patients with prior CABG undergoing invasive coronary angiography. 106 patients underwent CTCA prior to ICA and were compared to 729 patients undergoing conventional coronary angiography alone (control group). No significant differences were seen between the 2 groups in patient demographics and procedure characteristics (number of bypass grafts), and interventional cardiologist\'s experience. The CTCA group had lower contrast volumes (171.3mls vs 287.4mls, p<0.0001), radiation doses (Effective dose 4.6mSv vs 10.5mSv, p<0.0001) and procedure times (fluorosocopy time 9.5min vs 12.6min, p<0.0001) at the time of ICA compared to patients who did not have prior CTCA. Combined radiation doses (ICA + CTCA) vs ICA alone were similar (p=0.867) with significant reductions in overall contrast used seen in the CTCA group (p=0.005). Complete diagnostic studies were performed in all patients with prior CTCA (106 patients, 100%) compared to 543 patients (74.64%, p= <0.0001) of patients without previous CTCA, as a result 34 patients (4.4%) went on to have CTCA post angiography due to missed grafts. Of these 4 needed further invasive angiographic assessment and subsequent coronary intervention following the CTCA scan.
Conclusions
Prior CTCA improves graft detection at the time in coronary angiography and reduces the time necessary to localize graft ostium, the total procedure time duration, and volume of contrast media used.



EuroIntervention: 24 Jun 2019; epub ahead of print
Jones DA, Castle EV, Beirne AM, Rathod KS, ... Pugliese F, Mathur A
EuroIntervention: 24 Jun 2019; epub ahead of print | PMID: 31235457
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Impact:
Abstract

Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST-TAVI trial.

Barbanti M, van Mourik MS, Spence MS, Icovelli F, ... Vis M, Tamburino C
Aims
Treatment pathway optimisation in TAVI should include timely patient discharge with a minimised risk for out-of-hospital adverse events. The aim of this study was to define a standardised set of risk criteria that allows a safe and timely discharge, to validate their appropriateness prospectively in different centres and multiple European countries, and to assess post-discharge outcomes.
Methods and results
We defined and validated the adequacy of a set of discharge criteria and its ability to predict timely and safe discharge properly after the intervention in a prospective, European, multicentre registry. A total of 502 unselected patients were enrolled at 10 sites in three countries. The primary endpoint, defined as a composite of all-cause mortality, vascular access-related complications, permanent pacemaker implantation, stroke, re-hospitalisation due to cardiac reasons, kidney failure and major bleeding at 30 days, was reached in 12.9% of patients (95% CI: 11.3-16.5). The overall 30-day mortality was 1.1% (95% CI: 0.2-2.0), and the rates of stroke/TIA 1.7% (95% CI: -0.6 to 4.0), PPI 7.3% (95% CI: 5.8-8.9), major vascular complications 1.9% (95% CI: 0.7-3.1), major/life-threatening bleeding 2.4% (95% CI: 1.0-3.8) and cardiac re-hospitalisation 3.7% (95% CI: 1.4-6.0). Patients appropriately discharged early had a significantly lower risk of the primary endpoint (7.0 vs. 26.4%; p<0.001) which was reflected in some of its relevant components: stroke (0.0 vs. 2.8%; p=0.015), PPI (4.3 vs. 15.9%; p<0.001), major vascular complications (0.3 vs. 4.7%; p=0.004) and major/life-threatening bleeding (0.3 vs. 6.5%; p<0.001).
Conclusions
We validated the appropriateness of a pre-specified set of risk criteria that allows a safe and timely discharge. The rate of 30-day complications did not reveal any risk increase with this strategy compared with the reported outcomes in major TAVI trials and registries. ClinicalTrials.gov Identifier: NCT02404467.



EuroIntervention: 19 Jun 2019; 15:147-154
Barbanti M, van Mourik MS, Spence MS, Icovelli F, ... Vis M, Tamburino C
EuroIntervention: 19 Jun 2019; 15:147-154 | PMID: 30777842
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Abstract

Characterisation of lesions undergoing ischaemia-driven revascularisation after complete revascularisation versus culprit lesion only in patients with STEMI and multivessel disease: a DANAMI-3-PRIMULTI substudy.

De Backer O, Lønborg J, Helqvist S, Warnøe J, ... Kelbæk H, Engstrøm T
Aims
Treatment of the infarct-related artery only (IRA only) in ST-segment elevation myocardial infarction (STEMI) is associated with a significantly higher rate of ischaemia-driven revascularisation (ID-RV) during follow-up than fractional flow reserve-guided complete revascularisation (FFR-CRV). This study aimed to characterise all lesions which underwent ID-RV in the DANAMI-3-PRIMULTI trial with respect to location, stenosis grade and functional significance.
Methods and results
The study included 627 patients with STEMI and multivessel disease; 313 patients were randomised to treatment of the IRA only versus 314 undergoing staged FFR-CRV during the index admission. Rates of admission for suspected cardiac ischaemia (17%) were similar in both groups; however, ID-RV was significantly less frequent in the FFR-CRV group than in the IRA-only group (5% vs. 17%; p<0.001). In both groups, the primary reason for ID-RV was related to non-culprit, non-treated lesions (N=71/82 lesions in IRA-only; N=13/26 in FFR-CRV). De novo lesions or revascularisation of previously treated lesions were rarely causes of ID-RV. In the IRA-only group, there was a trend towards a higher ID-RV rate for lesions with a higher stenosis grade and located in more proximal segments - in particular, ≥80% stenosis of the left anterior descending and right coronary artery also led to angina class IV/unstable angina. In the FFR-CRV group, an FFR value ≤0.80 was shown to be an appropriate threshold for revascularisation.
Conclusions
FFR-CRV in STEMI is associated with a significantly lower rate of ID-RV at follow-up than treatment of the IRA only. This is due to a difference in non-culprit, non-treated lesions between both groups and not in de novo lesions or repeat revascularisation of previously treated lesions. Further considerations are warranted in case of high-grade non-culprit stenosis at proximal coronary segments, borderline FFR values and/or anticipated complex PCI.



EuroIntervention: 19 Jun 2019; 15:172-179
De Backer O, Lønborg J, Helqvist S, Warnøe J, ... Kelbæk H, Engstrøm T
EuroIntervention: 19 Jun 2019; 15:172-179 | PMID: 30666962
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Impact:

This program is still in alpha version.