Journal: EuroIntervention

Sorted by: date / impact
Abstract

Relationship between stent expansion and fractional flow reserve after percutaneous coronary intervention: a post hoc analysis of the DOCTORS trial.

Belguidoum S, Meneveau N, Motreff P, Ohlman P, ... Morel O, Amabile N
Background
The best criteria for adequate stent expansion assessment by intracoronary imaging remain debated and their correlation with post-PCI FFR values is unknown.
Aims
This study aimed to analyse the relationship between stent expansion criteria using optical coherence tomography (OCT) analysis and the final PCI functional result.
Methods
This post hoc analysis of the DOCTORS study included non-ST-elevation segment ACS patients undergoing OCT-guided PCI. The procedure functional result was assessed by the measurement of fractional flow reserve (FFR). Stent expansion was assessed on OCT runs according to the DOCTORS criteria and ILUMIEN III criteria.
Results
The study included N=116 patients (age: 60.8±11.5 years; male gender: 71%). The final expansion was considered optimal in 10%, acceptable in 9% and unacceptable in 81% of the stents according to ILUMIEN III criteria, although being successful in 70% of the patients according to the DOCTORS criteria. Hypertension and larger proximal reference segment dimension were independent predictors of inadequate device ILUMIEN III expansion. FFR values were, respectively, 0.93 (0.91-0.95) versus 0.95 (0.92-0.97) in patients with optimal+acceptable versus unacceptable ILUMIEN III expansion (p=0.22), 0.94 (0.91-0.97) versus 0.95 (0.93-0.97) in patients with optimal versus non-optimal DOCTORS expansion (p=0.23), and 0.95 (0.92-0.97) versus 0.92 (0.90-0.95) in patients with minimal stent area ≥4.5 mm2 versus <4.5 mm2 (p=0.03).
Conclusions
In this selected population, no relationship was observed between optimal stent expansion according to ILUMIEN III or DOCTORS OCT criteria and final post-PCI FFR values.



EuroIntervention: 10 Jun 2021; 17:e132-e139
Belguidoum S, Meneveau N, Motreff P, Ohlman P, ... Morel O, Amabile N
EuroIntervention: 10 Jun 2021; 17:e132-e139 | PMID: 32392171
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Abstract

Long-term outcomes of thrombectomy for acute ischaemic stroke by occluded artery and stroke aetiology: a PRAGUE-16 substudy.

Vavrova J, Koznar B, Peisker T, Vasko P, ... Petras M, Widimsky P
Background
Thrombectomy is an effective treatment for acute ischaemic stroke (AIS).
Aims
The aim of this study was to compare clinical outcomes with intracranial artery occlusion site among AIS patients treated in the setting of a cardiology cath lab.
Methods
This was a single-centre, prospective registry of 214 consecutive patients with AIS enrolled between 2012 and 2018. All thrombectomy procedures were performed in a cardiology cath lab with stent retrievers or aspiration systems. The functional outcome was assessed by the modified Rankin Scale (mRS) after three months.
Results
Ninety-three patients (44%) had middle cerebral artery (MCA) occlusion, 28 patients (13%) had proximal internal carotid artery (ICA) occlusion, 27 patients (13%) had tandem (ICA+MCA) occlusion, 39 patients (18%) had terminal ICA (T-type) occlusion, and 26 patients (12%) had vertebrobasilar (VB) stroke. Favourable clinical outcome (mRS ≤2) was reached in 58% of MCA occlusions and in 56% of isolated ICA occlusions, but in only 31% of T-type occlusions and in 27% of VB stroke. Poor clinical outcome in T-type occlusions and VB strokes was influenced by the lower recanalisation success (mTICI 2b-3 flow) rates: 56% (T-type) and 50% (VB) compared to 82% in MCA occlusions, 89% in isolated ICA occlusions and 96% in tandem occlusions.
Conclusions
Catheter-based thrombectomy achieved significantly better clinical results in patients with isolated MCA occlusion, isolated ICA occlusions or tight stenosis and tandem occlusions compared to patients with T-type occlusion and posterior strokes. Visual summary. Endovascular intervention of isolated MCA or ICA occlusions provides greatest clinical benefit, while interventions in posterior circulation have lower chance for clinical success.



EuroIntervention: 10 Jun 2021; 17:e169-e177
Vavrova J, Koznar B, Peisker T, Vasko P, ... Petras M, Widimsky P
EuroIntervention: 10 Jun 2021; 17:e169-e177 | PMID: 32420880
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Abstract

Treatment of acute pulmonary embolism using rheolytic thrombectomy.

Li K, Cui M, Zhang K, Liang K, Liu H, Zhai S
Background
The AngioJet rheolytic thrombectomy (ART) system can quickly fragment and aspirate thrombi according to Bernoulli\'s principle.
Aims
This retrospective study aimed to evaluate the therapeutic effects of the ART system in treating severe acute pulmonary embolism (APE), including high-risk pulmonary embolism (HR-PE) and intermediate-high-risk pulmonary embolism (IHR-PE).
Methods
Forty-four APE patients (21 HR-PE and 23 IHR-PE) were enrolled and underwent pulmonary ART using the 6 Fr Solent Omni AngioJet device. Nineteen patients were diagnosed with APE and lower extremity deep venous thrombosis (LEDVT), and underwent thrombectomy of APE and LEDVT simultaneously using ART. All patients also received local thrombolysis with urokinase.
Results
The results showed that the mean length of stay in intensive care units was 2.4±1.9 days. Significant improvements in clinical, haemodynamic and angiographic parameters were observed in both groups; the improvements in shock index, PaO2, and angiographic parameters were more obvious in the IHR-PE group. Six of the 44 patients died in hospital. During the follow-up, 35 of 38 patients were functioning well and no recurrence of APE was observed.
Conclusions
Pulmonary ART plus local thrombolysis of the pulmonary artery for HR-PE or IHR-PE is feasible and appears to be safe. Further studies are warranted to investigate comparative efficacy compared to existing treatments.



EuroIntervention: 10 Jun 2021; 17:e158-e166
Li K, Cui M, Zhang K, Liang K, Liu H, Zhai S
EuroIntervention: 10 Jun 2021; 17:e158-e166 | PMID: 32863245
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Abstract

Identification of the type of stent with three-dimensional optical coherence tomography: the SPQR study.

Cortes C, Chu M, Schincariol M, Martínez-Hervás Alonso MÁ, ... Silber S, Gutiérrez-Chico JL
Background
The ability of optical coherence tomography (OCT) to identify specific types of stent has never been systematically studied.
Aims
The aim of this study was to test the accuracy of OCT imaging to identify patterns of stent platform and subsequently identify the type of stent implanted.
Methods
Consecutive patients from six international centres were retrospectively screened, searching for OCT studies with metallic stents or scaffolds. The sample was analysed by two blinded operators, applying a dedicated protocol in four steps to identify the type of stent: 1) 3D and automatic strut detection (ASD), 2) 3D tissue view, 3) longitudinal view with ASD, 4) mode \"stent only\" and ASD.
Results
A series of 212 patients underwent OCT in the study centres, finding 294 metallic stents or scaffolds in 146 patients. The protocol correctly identified 285 stents (96.9%, kappa 0.965), with excellent interobserver agreement (kappa 0.988). The performance tended to be better in recently implanted stents (kappa 0.993) than in stents implanted ≥3 months before (kappa 0.915), and in pullback speed 18 mm/s as compared with 36 mm/s (kappa 0.969 vs 0.940, respectively).
Conclusions
The type of stent platform can be accurately identified in OCT by trained analysts following a dedicated protocol, combining 3D-OCT, ASD and longitudinal view. This might be clinically helpful in scenarios of device failure and for the quantification of apposition. The blinding of analysts in OCT studies should be revisited.



EuroIntervention: 10 Jun 2021; 17:e140-e148
Cortes C, Chu M, Schincariol M, Martínez-Hervás Alonso MÁ, ... Silber S, Gutiérrez-Chico JL
EuroIntervention: 10 Jun 2021; 17:e140-e148 | PMID: 32928714
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Abstract

Optical coherence tomography to guide percutaneous coronary intervention of the left main coronary artery: the LEMON study.

Amabile N, Rangé G, Souteyrand G, Godin M, ... Motreff P, Caussin C
Background
Intravascular ultrasound (IVUS)-guided PCI improves the prognosis of left main stem (LMS) PCI and is currently recommended by international guidelines. Although OCT resolution is greater than that of IVUS, this tool is not yet recommended in LMS angioplasty due to the absence of data.
Aims
This pilot study aimed to analyse the feasibility, safety and impact of OCT-guided LMS PCI.
Methods
This prospective, multicentre trial investigated whether patients might benefit from OCT-guided PCI for mid/distal LMS according to a pre-specified protocol. The primary endpoint was procedural success defined as follows: residual angiographic stenosis <50% + TIMI 3 flow in all branches + adequate OCT stent expansion (LEMON criteria).
Results
Seventy patients were included in the final analysis (median age: 72 [64-81] years, 73% male). The OCT pre-specified protocol was applied in all patients. The primary endpoint was achieved in 86% of subjects. Adequate stent expansion was observed in 86%, significant edge dissection in 30% and residual significant strut malapposition in 24% of the cases. OCT guidance modified the operators\' strategy in 26% of the patients. The rate of one-year survival free from major adverse clinical events was 98.6% (97.2-100).
Conclusions
This pilot study is the first to report the feasibility and performance of OCT-guided LMS PCI according to a pre-specified protocol.



EuroIntervention: 10 Jun 2021; 17:e124-e131
Amabile N, Rangé G, Souteyrand G, Godin M, ... Motreff P, Caussin C
EuroIntervention: 10 Jun 2021; 17:e124-e131 | PMID: 33226003
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Abstract

Intracoronary optical coherence tomography: state of the art and future directions.

Ali ZA, Karimi Galougahi K, Mintz GS, Maehara A, Shlofmitz RA, Mattesini A
Optical coherence tomography (OCT) has been increasingly utilised to guide percutaneous coronary intervention (PCI). Despite the diagnostic utility of OCT, facilitated by its high resolution, the impact of intracoronary OCT on clinical practice has thus far been limited. Difficulty in transitioning from intravascular ultrasound (IVUS), complex image interpretation, lack of a standardised algorithm for PCI guidance, and paucity of data from prospective clinical trials have contributed to the modest adoption. Herein, we provide a comprehensive up-do-date overview on the utility of OCT in coronary artery disease, including technical details, device set-up, simplified OCT image interpretation, recognition of the imaging artefacts, and an algorithmic approach for using OCT in PCI guidance. We discuss the utility of OCT in acute coronary syndromes, provide a summary of the clinical trial data, list the work in progress, and discuss the future directions.



EuroIntervention: 10 Jun 2021; 17:e105-e123
Ali ZA, Karimi Galougahi K, Mintz GS, Maehara A, Shlofmitz RA, Mattesini A
EuroIntervention: 10 Jun 2021; 17:e105-e123 | PMID: 34110288
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Abstract

Optimal Dual Antiplatelet Therapy Duration for Bioresorbable Scaffolds: an Individual Patient Data Pooled Analysis of the ABSORB Trials.

Azzalini L, Ellis SG, Kereiakes DJ, Kimura T, ... Serruys PW, Stone GW
Background
Compared with everolimus-eluting metallic stents, the Absorb bioresorbable scaffold (BRS) results in increased rates of myocardial infarction (MI) and scaffold thrombosis (ST) during its 3-year bioresorption phase. It is unknown whether prolonged dual antiplatelet therapy (DAPT) duration might decrease the risk of ischemic events.
Aims
We sought to evaluate the impact of DAPT duration on ischemic and bleeding outcomes following BRS implantation.
Methods
We conducted an individual patient-data pooled analysis from 4 ABSORB randomized trials and 1 prospective ABSORB registry. Study endpoints were MI, ST, bleeding, and death through 3-year follow-up. Propensity score-adjusted Cox regression analysis was used to account for baseline differences related to DAPT duration.
Results
The five ABSORB studies included 2,973 patients. DAPT use was 91.7%, 53.2%, and 48.0% at 1, 2, and 3 years, respectively. DAPT use within the first year after BRS implantation was associated with markedly lower risks of MI (adjusted hazard ratio [aHR] 0.17, 95%CI 0.10-0.32, p&lt;0.0001) and ST (aHR 0.08, 95%CI 0.03-0.19, p&lt;0.0001). Conversely, DAPT use between 1 and 3 years did not significantly affect the risk of MI (aHR 1.04, 95%CI 0.70-1.55, p=0.84) or ST (aHR 0.86, 95%CI 0.42-1.75, p=0.67). DAPT did not have major effects upon bleeding or death in either period.
Conclusions
DAPT use during the first year after BRS implantation was strongly associated with lower risks of ST and MI. However, a benefit of ongoing DAPT use between 1 and 3 years after BRS implantation was not apparent.



EuroIntervention: 07 Jun 2021; epub ahead of print
Azzalini L, Ellis SG, Kereiakes DJ, Kimura T, ... Serruys PW, Stone GW
EuroIntervention: 07 Jun 2021; epub ahead of print | PMID: 34105515
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Abstract

Optical Flow Ratio for Assessing Stenting Result and Physiological Significance of Residual Disease.

Ding D, Yu W, Tauzin H, De Maria GL, ... Wijns W, Tu S
Background
Optical flow ratio (OFR) is a novel method for fast computation of fractional flow reserve (FFR) from optical coherence tomography (OCT) images.
Aims
We aimed to evaluate the accuracy of OFR in predicting post-percutaneous coronary intervention (PCI) FFR and to evaluate the impact of stent expansion on within-stent OFR pressure drop (In-stent OFR).
Methods
Post-PCI OFR was computed in patients with both OCT and FFR interrogation immediately after PCI. Calculation of post-PCI OFR (called simulated residual OFR) from pre-PCI OCT pullbacks after elimination of the stenotic segment by virtual stenting was performed in a subgroup of patients who had pre-PCI OCT images. Stent underexpansion was quantified by the minimum expansion index (MEI) of the stented segment.
Results
A total of 125 paired comparisons between post-PCI OFR and FFR were obtained in 119 patients, among which simulated residual OFR was obtained in 64 vessels. Mean post-PCI FFR was 0.92 ± 0.05. Post-PCI OFR showed good correlation (r = 0.74, p&lt;0.001) and agreement (mean difference = -0.01 ± 0.03, p = 0.051) with FFR. The accuracy in predicting post-PCI FFR≤0.90 was 84% for post-PCI OFR. Simulated residual OFR significantly correlated with post-PCI FFR (r = 0.42, p&lt;0.001). MEI showed moderate correlation (r=-0.49, p&lt;0.001) with In-stent OFR.
Conclusions
Post-PCI OFR showed good diagnostic concordance with post-PCI FFR. Simulated residual OFR significantly correlated with post-PCI FFR. Stent underexpansion significantly correlated with in-stent pressure drop.



EuroIntervention: 07 Jun 2021; epub ahead of print
Ding D, Yu W, Tauzin H, De Maria GL, ... Wijns W, Tu S
EuroIntervention: 07 Jun 2021; epub ahead of print | PMID: 34105514
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Impact:
Abstract

Impact of Clinical Presentation on Bleeding Risk after Percutaneous Coronary Intervention and Implications for the ARC-HBR Definition.

Gragnano F, Spirito A, Corpataux N, Vaisnora L, ... Räber L, Valgimigli M
Background
The identification of bleeding risk factors in patients undergoing percutaneous coronary intervention (PCI) is essential to inform subsequent management. Whether clinical presentation per se affects bleeding risk after PCI remains unclear.
Aims
We aimed to assess whether clinical presentation per se predisposes to bleeding in patients undergoing PCI and if the Academic Research Consortium (ARC)-high bleeding risk (HBR) criteria perform consistently among acute (ACS) and chronic (CCS) coronary syndrome patients.
Methods
Consecutive patients undergoing PCI from the Bern PCI Registry were stratified by clinical presentation. Bleeding events at 1 year were compared in ACS versus CCS patients, and the originally-defined ARC-HBR criteria were assessed.
Results
Among 16,821 patients, 9,503 (56.5%) presented with ACS. At 1 year, BARC 3 or 5 bleeding occurred in 4.97% and 3.60% of patients with ACS and CCS, respectively. After adjustment, ACS remained associated with higher BARC 3 or 5 bleeding risk (adjusted HR: 1.21; 95% CI: 1.01-1.43; p=0.034), owing to non-access site-related occurrences, which mainly accrued within the first 30 days after PCI. The ARC-HBR score had lower discrimination among ACS compared with CCS patients, and its performance slightly improved when ACS was computed as a minor criterion.
Conclusions
ACS presentation per se predicts 1-year major bleeding risk after PCI. The ARC-HBR score discrimination appeared lower in ACS than CCS, and its overall performance improved numerically when ACS was computed as an additional minor risk criterion.



EuroIntervention: 07 Jun 2021; epub ahead of print
Gragnano F, Spirito A, Corpataux N, Vaisnora L, ... Räber L, Valgimigli M
EuroIntervention: 07 Jun 2021; epub ahead of print | PMID: 34105513
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Abstract

Near-Infrared Spectroscopy to Predict Microvascular Obstruction after Primary Percutaneous Coronary Intervention.

Terada K, Kubo T, Madder RD, Ino Y, ... Wada T, Akasaka T
Background
Successful restoration of epicardial coronary artery patency by primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI) does not always lead to adequate reperfusion at the microvascular level.
Aims
This study sought to investigate the association between lipid-rich coronary plaque identified by near-infrared spectroscopy combined with intravascular ultrasound (NIRS-IVUS) and microvascular obstruction (MVO) detected by cardiac magnetic resonance imaging (MRI) after PPCI for STEMI.
Methods
We investigated 120 patients with STEMI undergoing PPCI. NIRS-IVUS was used to measure the maximum lipid-core burden index in 4 mm (maxLCBI4mm) in the infarct-related lesions before PPCI. Delayed contrast-enhanced cardiac MRI was performed to evaluate MVO 1 week after PPCI.
Results
MVO was identified in 40 (33%) patients. MaxLCBI4mm in the infarct-related lesion was significantly larger in the MVO group compared with the no-MVO group (median [interquartile range]: 745 [522-853] vs. 515 [349-698], p&lt;0.001). Multivariable logistic regression model showed that maxLCBI4mm was an independent predictor of MVO (odds ratio: 24.7 [95% confidence interval: 2.5-248.0], p=0.006). Receiver-operating characteristic curve analysis demonstrated that maxLCBI4mm &gt;600 was the optimal cut-off value to predict MVO (Youden index = 0.44 and area under the curve = 0.71) with a sensitivity of 75% and a specificity of 69%.
Conclusions
Lipid content measured by NIRS in the infarct-related lesions was associated with the occurrence of MVO after PPCI in STEMI.



EuroIntervention: 07 Jun 2021; epub ahead of print
Terada K, Kubo T, Madder RD, Ino Y, ... Wada T, Akasaka T
EuroIntervention: 07 Jun 2021; epub ahead of print | PMID: 34105512
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Abstract

Balloon Aortic Valvuloplasty for Severe Aortic Stenosis Before Urgent Noncardiac Surgery.

Debry N, Altes A, Vincent F, Delhaye C, ... Marechaux S, Van Belle E
Background
Balloon aortic valvuloplasty (BAV) has been proposed as a therapeutic option in patients suffering from severe aortic stenosis (SAS) who need urgent noncardiac surgery (NCS). Whether this strategy is better than medical therapy in this very peculiar population is unknown.
Aims
We evaluated the clinical benefit of an invasive strategy (IS) with preoperative BAV in patients with SAS requiring urgent NCS.
Methods
From 2011 to 2019, a registry conducted in 2 centers included 133 patients with SAS undergoing urgent NCS, of whom n=93 underwent preoperative BAV (IS) and n=40 a conservative strategy (CS) without BAV. All analyses were adjusted for confounding using inverse probability of treatment weighting (IPTW) (10 clinical and anatomical variables). The primary outcome was the MACE at 1-month follow-up after NCS including mortality, heart-failure, and other cardiovascular outcomes.
Results
In patients managed conservatively, occurrence of MACE was 20.0%(n=8) and death was 10.0%(n=4) at 1 month. In patients undergoing BAV, occurrence of MACE was 20.4%(n=19) and death was 5.4%(n=5) at 1-month. Among patients undergoing conservative management, all events were observed after NCS while in patients undergoing BAV, 12.9%(n=12) had events between BAV and NCS including 3 deaths and 7.5% (n=7) after NCS including 2 deaths. In IPTW-propensity analyses, the incidence of the primary outcome (20.4% vs. 20.0%;OR=0.93;95%CI:0.38-2.29) and 3-months survival (89.2% vs. 90.0%;IPTW-adjustedHR=0.90;95%CI:0.31-2.60) were similar in both groups.
Conclusions
Patients with SAS managed conservatively before urgent NCS are at high risk of events. A systematic invasive strategy using BAV does not provide a significant improvement in clinical outcome.



EuroIntervention: 07 Jun 2021; epub ahead of print
Debry N, Altes A, Vincent F, Delhaye C, ... Marechaux S, Van Belle E
EuroIntervention: 07 Jun 2021; epub ahead of print | PMID: 34105511
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Abstract

Joint EAPCI/ACVC expert consensus document on percutaneous ventricular assist devices.

Chieffo A, Dudek D, Hassager C, Combes A, ... Werner N, Price S
There has been a significant increase in the use of short-term percutaneous ventricular assist devices (pVADs) as acute circulatory support in cardiogenic shock and to provide haemodynamic support during interventional procedures, including high-risk percutaneous coronary interventions. Although frequently considered together, pVADs differ in their haemodynamic effects, management, indications, insertion techniques, and monitoring requirements. This consensus document summarizes the views of an expert panel by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the Association for Acute Cardiovascular Care (ACVC) and appraises the value of short-term pVAD. It reviews the pathophysiological context and possible indications for pVAD in different clinical settings and provides guidance regarding the management of pVAD based on existing evidence and best current practice.



EuroIntervention: 30 May 2021; epub ahead of print
Chieffo A, Dudek D, Hassager C, Combes A, ... Werner N, Price S
EuroIntervention: 30 May 2021; epub ahead of print | PMID: 34057071
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Abstract

Incidence and Standardized Definitions of Mitral Valve Leaflet Adverse Events After Transcatheter Mitral Valve Repair: the EXPAND Study.

Asch FM, Little SH, Mackensen GB, Grayburn PA, ... Maisano F, Kar S
Background
An independent panel of experts reviewed all investigator-reported cases of mitral valve leaflet adverse events (LAE) after MitraClipTM NTR/XTR in the EXPAND Study.
Aims
We aimed to report the findings of the expert panel and standardize definitions for LAE.
Methods
Standard definitions for different types of LAE were formulated and events adjudicated after detailed review by the expert panel.
Results
Enrolling centers reported LAE in 35 cases, 11 leaflet injuries (9 tear, 2 perforation) and 24 single leaflet device attachment (SLDA). The panel confirmed LAE in 20 cases (2.0% incidence), 18 patients had SLDA and 4 had leaflet injury (2 cases had both SLDA and injury). Leaflet injury occurred during device implant and resulted in surgical valve replacement or death. SLDA-alone events were identified during implant (n=2), pre-discharge (7) or at 30 days of follow-up (7) and were resolved (£ 2+ residual MR) with additional clips in 75% of cases.
Conclusions
Mitral valve repair with MitraClipTM NTR/XTR is safe. The rate of LAE is lower than previously reported using older generation devices. The proposed definitions and findings will help differentiate leaflet injury from inadequate leaflet insertion and SLDA, and provide guidance to consistently diagnose LAE post MitraClipTM.



EuroIntervention: 24 May 2021; epub ahead of print
Asch FM, Little SH, Mackensen GB, Grayburn PA, ... Maisano F, Kar S
EuroIntervention: 24 May 2021; epub ahead of print | PMID: 34031024
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Abstract

Outcomes of Valve-in-Valve Transcatheter Aortic Valve Implantation with and without Bioprosthetic Valve Fracture.

Brinkmann C, Abdel-Wahab M, Bedogni F, Bhadra OD, ... Wohlmuth P, Schofer J
Background
Bioprosthetic valve fracture (BVF) is a technique to reduce gradients in valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) procedures. Outcome of VIV-TAVI with BVF has not been compared with VIV-TAVI without BVF.
Aims
To evaluate the outcome of VIV-TAVI with BVF compared to VIV-TAVI without BVF.
Methods
In total, 81 cases of BVF-VIV-TAVI (BVF-group) from 14 centres were compared to 79 cases of VIV-TAVI without BVF (control-group).
Results
VARC-2 defined device success was 93% in the BVF- and 68.4% in the control-group (p&lt;0.001). The mean transvalvular gradient decreased from 37 ± 13mmHg to 10.8 ± 5.9mmHg (p&lt;0.001) in the BVF- and from 35 ± 16mmHg to 15.8 ± 6.8mmHg (p&lt;0.001) in the control-group with a significantly higher final gradient in control (p&lt;0.001). The transvalvular gradients did not significantly change over time. In-hospital major adverse events occurred in 3.7% in BVF- and 7.6% in control-group (p=0.325). A linear mixed model identified BVF, self-expanding transcatheter heart valves (THVs) and other surgical aortic valve (SAV) types other than Mitroflow as predictors for lower transvalvular gradients.
Conclusions
Compared to VIV-TAVI alone, VIV-TAVI with BVF resulted in a significantly lower transvalvular gradient acutely and at follow-up. Independent predictors for lower gradients were the use of self-expanding THVs and the treatment of SAVs other than Mitroflow, irrespective of BVF-performance. BVF significantly reduced the gradient independently from transcatheter or surgical valve type.



EuroIntervention: 24 May 2021; epub ahead of print
Brinkmann C, Abdel-Wahab M, Bedogni F, Bhadra OD, ... Wohlmuth P, Schofer J
EuroIntervention: 24 May 2021; epub ahead of print | PMID: 34031022
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Abstract

Clopidogrel Monotherapy in Patients with and without On-Treatment High Platelet Reactivity: a SMART-CHOICE sub-study.

Lee SH, Lee SY, Chun WJ, Song YB, ... Gwon HC, Hahn JY
Background
Although P2Y12 inhibitor monotherapy has been emerged as a promising alternative for dual antiplatelet therapy (DAPT), there remains concern regarding safety of clopidogrel monotherapy.
Aims
We sought to investigate clinical outcomes of clopidogrel monotherapy in patients with and without on-treatment high platelet reactivity (HPR).
Methods
In the SMART-CHOICE study, 3-month DAPT followed by P2Y12 inhibitor monotherapy was compared with 12-month DAPT undergoing percutaneous coronary intervention. Of these, platelet function test was performed for 833 patients with clopidogrel-based therapy. The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE: a composite of all-cause death, myocardial infarction, or stroke) at 12 months.
Results
Overall, 108 (13.0%) patients had HPR on clopidogrel. Patients with HPR had a significantly higher rate of MACCE than patients without HPR (8.7% vs 1.5%, adjusted HR 3.036, 95% CI 1.060-8.693, P=0.038). Treatment effect of clopidogrel monotherapy for the 12-month MACCE was not significantly different compared with DAPT among patients with HPR (8.0% vs. 9.4%, adjusted HR 0.718, 95% CI 0.189-2.737, P=0.628) and without HPR (2.2% vs. 0.9%, adjusted HR 2.587, 95% CI 0.684-9.779, P=0.161; adjusted P for interaction=0.170).
Conclusions
Clopidogrel monotherapy showed treatment effects comparable to DAPT for MACCE in patients with or without HPR. However, HPR was significantly associated with an increased risk of MACCE in clopidogrel-treated patients regardless of maintenance of aspirin.



EuroIntervention: 24 May 2021; epub ahead of print
Lee SH, Lee SY, Chun WJ, Song YB, ... Gwon HC, Hahn JY
EuroIntervention: 24 May 2021; epub ahead of print | PMID: 34031020
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Impact:
Abstract

A multicentre, prospective, randomised controlled trial to assess the safety and effectiveness of cooling as an adjunctive therapy to percutaneous intervention in patients with acute myocardial infarction: the COOL AMI EU Pivotal Trial.

Noc M, Laanmets P, Neskovic AN, Petrović M, ... Erlinge D, Keeble TR
Background
Despite primary PCI (PPCI), ST-elevation myocardial infarction (STEMI) can still result in large infarct size (IS). New technology with rapid intravascular cooling showed positive signals for reduction in IS in anterior STEMI.
Aims
We investigated the effectiveness and safety of rapid systemic intravascular hypothermia as an adjunct to PPCI in conscious patients, with anterior STEMI, without cardiac arrest.
Methods
Hypothermia was induced using the ZOLL® Proteus™ intravascular cooling system. After randomisation of 111 patients, 58 to hypothermia and 53 to control groups, the study was prematurely discontinued by the sponsor due to inconsistent patient logistics between the groups resulting in significantly longer total ischaemic delay in the hypothermia group (232 vs 188 minutes; p&lt;0.001).
Results
There were no differences in angiographic features and PPCI result between the groups. Intravascular temperature at wire crossing was 33.3+0.9°C. Infarct size/left ventricular mass (IS/LV) by cardiac magnetic resonance (CMR) at day 4-6 was 21.3% in the hypothermia group and 20.0% in the control group (p=0.540). Major adverse cardiac events at 30 days increased non-significantly in the hypothermia group (8.6% vs 1.9%; p=0.117) while cardiogenic shock (10.3% vs 0%; p=0.028) and paroxysmal atrial fibrillation (43.1% vs 3.8%; p&lt;0.001) were significantly more frequent in the hypothermia group.
Conclusions
The ZOLL Proteus intravascular cooling system reduced temperature to 33.3°C before PPCI in patients with anterior STEMI. Due to inconsistent patient logistics between the groups, this hypothermia protocol resulted in a longer ischaemic delay, did not reduce IS/LV mass and was associated with increased adverse events.



EuroIntervention: 17 May 2021; epub ahead of print
Noc M, Laanmets P, Neskovic AN, Petrović M, ... Erlinge D, Keeble TR
EuroIntervention: 17 May 2021; epub ahead of print | PMID: 34031023
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Impact:
Abstract

Thirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: The TriBAND study.

Nickenig G, Friedrichs KP, Baldus S, Arnold M, ... Hahn RT, Windecker S
Background
Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality.
Aims
We evaluated the safety and effectiveness of the Cardioband tricuspid valve reconstruction system (Edwards Lifesciences, Irvine, CA, USA) from the ongoing European single-arm, multicentre, prospective TriBAND post-market clinical follow-up study.
Methods
Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team.
Results
Sixty-one patients had ≥severe functional TR. At baseline, 85% of patients were in NYHA Class III-IV, 94% had ≥severe TR (core laboratory-assessed) with 6.8% EuroSCORE II and 53% LVEF. Device success was 96.7%. At discharge, 59% (p&lt;0.001) of patients achieved ≤moderate TR and 78% had at least one grade TR reduction. At 30 days, all-cause mortality and composite MAE rates were 1.6% and 19.7%, respectively; septolateral annular diameter was reduced by 20%, where 69% of patients achieved ≤moderate TR and 85% of patients had at least one grade TR reduction (all p&lt;0.001). Mid-RVEDD, RA volume, and IVC diameter decreased by 10% (p=0.005), 21% (p&lt;0.001), and 11% (p=0.022), respectively; 74% were in NYHA Class I-II (p&lt;0.001) with improvements in overall KCCQ score by 17 points (p&lt;0.001).
Conclusions
In the TriBAND study, the Cardioband tricuspid system demonstrated favourable outcomes at discharge and 30 days in a challenging patient population with symptomatic ≥severe functional TR. Results showed significant reductions in annular diameter and TR severity, accompanied by early evidence of right heart remodelling and improvements in functional status and quality of life.



EuroIntervention: 17 May 2021; epub ahead of print
Nickenig G, Friedrichs KP, Baldus S, Arnold M, ... Hahn RT, Windecker S
EuroIntervention: 17 May 2021; epub ahead of print | PMID: 34031021
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Impact:
Abstract

Pharmacokinetics, pharmacodynamics, and tolerability of subcutaneous administration of a novel glycoprotein IIb/IIIa inhibitor, RUC-4, in patients with ST-segment elevation myocardial infarction.

Bor WL, Zheng KL, Tavenier AH, Gibson CM, ... van \'t Hof AWJ, Ten Berg JM
Background
Pre-hospital platelet inhibition in patients with ST-segment elevation myocardial infarction (STEMI) may improve outcomes. RUC-4 is a novel, second-generation glycoprotein IIb/IIIa inhibitor designed for first-point-of-medical-contact treatment for STEMI by subcutaneous injection.
Aims
The open-label, phase 2A, CEL-02 trial aimed to assess the pharmacodynamics (PD), pharmacokinetics (PK), and tolerability of RUC-4 in STEMI patients undergoing primary PCI (pPCI).
Methods
A total of 27 STEMI patients received a weight-adjusted subcutaneous injection of RUC-4 before pPCI in escalating doses (0.075 mg/kg [n=8], 0.090 mg/kg [n=9], or 0.110 mg/kg [n=10]).
Results
The primary PD endpoint of high-grade (≥77%) inhibition of the VerifyNow iso-TRAP assay at 15 minutes was met in 3/8, 7/8, and 7/8 patients in the three cohorts with a dose-response relationship (mean inhibition [min - max] of 77.5% [65.7%-90.6%], 87.5% [73.8%-93.1%], and 91.7% [76.4%-99.3%], respectively; ptrend=0.002). Fifty percent (50%) inhibition remained after 89.1 (38.0-129.7), 104.2 (17.6-190.8), and 112.4 (19.7-205.0) minutes. Injection site reactions or bruising were observed in 1 (4%) and 11 (41%) patients, respectively. Mild access-site haematomas occurred in 6 (22%), and severe access-site haematomas occurred in 2 patients (7%). No thrombocytopaenia was observed within 72 hours post dose.
Conclusions
In patients with STEMI, a single subcutaneous dose of RUC-4 at 0.075, 0.090, and 0.110 mg/kg showed dose-response high-grade inhibition of platelet function within 15 minutes.



EuroIntervention: 17 May 2021; epub ahead of print
Bor WL, Zheng KL, Tavenier AH, Gibson CM, ... van 't Hof AWJ, Ten Berg JM
EuroIntervention: 17 May 2021; epub ahead of print | PMID: 34031019
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Impact:
Abstract

EAPCI Core Curriculum for Percutaneous Cardiovascular Interventions (2020): Committee for Education and Training European Association of Percutaneous Cardiovascular Interventions (EAPCI). A branch of the European Society of Cardiology.

Van Belle E, Teles RC, Pyxaras SA, Kalpak O, ... Haude M, Dudek D
The proposed 2020 Core Curriculum for Percutaneous Cardiovascular Interventions aims to provide an updated European consensus that defines the level of experience and knowledge in the field of percutaneous cardiovascular intervention (PCI). It promotes homogenous education and training programmes among countries, and is the cornerstone of the new EAPCI certification, designed to support the recognition of competencies at the European level and the free movement of certified specialists in the European Community. It is based on a thorough review of the ESC guidelines and of the EAPCI textbook on percutaneous interventional cardiovascular medicine. The structure of the current core curriculum evolved from previous EAPCI core curricula and from the \"2013 core curriculum of the general cardiologist\" to follow the current ESC recommendations for core curricula. In most subject areas, there was a wide - if not unanimous - consensus among the task force members on the training required for the interventional cardiologist of the future. The document recommends that acquisition of competence in interventional cardiology requires at least two years of postgraduate training, in addition to four years devoted to cardiology. The first part of the curriculum covers general aspects of training and is followed by a comprehensive description of the specific components in 54 chapters. Each of the chapters includes statements of the objectives, and is further subdivided into the required knowledge, skills, behaviours, and attitudes.



EuroIntervention: 16 May 2021; 17:23-31
Van Belle E, Teles RC, Pyxaras SA, Kalpak O, ... Haude M, Dudek D
EuroIntervention: 16 May 2021; 17:23-31 | PMID: 32624457
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Impact:
Abstract

Transient acute right coronary artery deformation during transcatheter interventional tricuspid repair with the Cardioband tricuspid system.

Gerçek M, Rudolph V, Arnold M, Beuthner BE, ... Friedrichs KP, Jacobshagen C
Background
The Cardioband tricuspid valve reconstruction system is a size-adjustable tricuspid reconstruction device for interventional treatment of tricuspid regurgitation (TR). Contraction of the device after successful implantation can be associated with an acute deformation of the right coronary artery (RCA).
Aims
The aim of this study was to provide data on the persistence and clinical significance of acute RCA deformation following Cardioband implant procedures.
Methods
Data from all patients with intraprocedural RCA deformation during Cardioband implantation were collected from four centres between October 2018 and January 2020. Control angiographies were performed in all of these patients before discharge.
Results
RCA deformation occurred in 14 out of 51 patients. Follow-up coronary angiography showed a complete resolution of deformation in all cases while patients remained clinically asymptomatic and had an uneventful post-interventional course. Intraprocedural coronary stent implantation was performed in two of the earlier cases according to the personal assessment of the implanters.
Conclusions
RCA deformation is relatively frequent following interventional tricuspid annuloplasty but appears to be completely reversible in the absence of flow impairment or vascular damage. Based on our early experience watchful waiting is the most appropriate strategy to avoid unnecessary coronary interventions.



EuroIntervention: 16 May 2021; 17:81-87
Gerçek M, Rudolph V, Arnold M, Beuthner BE, ... Friedrichs KP, Jacobshagen C
EuroIntervention: 16 May 2021; 17:81-87 | PMID: 32657277
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Impact:
Abstract

Training and validation of a deep learning architecture for the automatic analysis of coronary angiography.

Du T, Xie L, Zhang H, Liu X, ... Lansky AJ, Xu B
Background
In recent years, the use of deep learning has become more commonplace in the biomedical field and its development will greatly assist clinical and imaging data interpretation. Most existing machine learning methods for coronary angiography analysis are limited to a single aspect.
Aims
We aimed to achieve an automatic and multimodal analysis to recognise and quantify coronary angiography, integrating multiple aspects, including the identification of coronary artery segments and the recognition of lesion morphology.
Methods
A data set of 20,612 angiograms was retrospectively collected, among which 13,373 angiograms were labelled with coronary artery segments, and 7,239 were labelled with special lesion morphology. Trained and optimised by these labelled data, one network recognised 20 different segments of coronary arteries, while the other detected lesion morphology, including measures of lesion diameter stenosis as well as calcification, thrombosis, total occlusion, and dissection detections in an input angiogram.
Results
For segment prediction, the recognition accuracy was 98.4%, and the recognition sensitivity was 85.2%. For detecting lesion morphologies including stenotic lesion, total occlusion, calcification, thrombosis, and dissection, the F1 scores were 0.829, 0.810, 0.802, 0.823, and 0.854, respectively. Only two seconds were needed for the automatic recognition.
Conclusions
Our deep learning architecture automatically provides a coronary diagnostic map by integrating multiple aspects. This helps cardiologists to flag and diagnose lesion severity and morphology during the intervention.



EuroIntervention: 16 May 2021; 17:32-40
Du T, Xie L, Zhang H, Liu X, ... Lansky AJ, Xu B
EuroIntervention: 16 May 2021; 17:32-40 | PMID: 32830647
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Impact:
Abstract

Antithrombotic therapy after percutaneous coronary intervention of bifurcation lesions.

Zimarino M, Angiolillo DJ, Dangas G, Capodanno D, ... Mehran R, Stankovic G
Coronary bifurcations exhibit localised turbulent flow and an enhanced propensity for atherothrombosis, platelet deposition and plaque rupture. Percutaneous coronary intervention (PCI) of bifurcation lesions is associated with an increased risk of thrombotic events. Such risk is modulated by anatomical complexity, intraprocedural factors and pharmacological therapy. There is no consensus on the appropriate PCI strategy or the optimal regimen and duration of antithrombotic treatment in order to decrease the risk of ischaemic and bleeding complications in the setting of coronary bifurcation. A uniform therapeutic approach meets a clinical need. The present initiative, promoted by the European Bifurcation Club (EBC), involves opinion leaders from Europe, America, and Asia with the aim of analysing the currently available evidence. Although mainly derived from small dedicated studies, substudies of large trials or from authors\' opinions, an algorithm for the optimal management of patients undergoing bifurcation PCI, developed on the basis of clinical presentation, bleeding risk, and intraprocedural strategy, is proposed here.



EuroIntervention: 16 May 2021; 17:59-66
Zimarino M, Angiolillo DJ, Dangas G, Capodanno D, ... Mehran R, Stankovic G
EuroIntervention: 16 May 2021; 17:59-66 | PMID: 32928716
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Impact:
Abstract

Revascularisation or medical therapy in elderly patients with acute anginal syndromes: the RINCAL randomised trial.

de Belder A, Myat A, Blaxill J, Haworth P, ... Robinson DR, Hildick-Smith D
Background
Historically the elderly have been under-represented in non-ST-elevation myocardial infarction (NSTEMI) management trials.
Aims
The aim of this trial was to demonstrate that an intervention-guided strategy is superior to optimal medical therapy (OMT) alone for treating NSTEMI in elderly individuals.
Methods
Patients (≥80 years, chest pain, ischaemic ECG, and elevated troponin) were randomised 1:1 to an intervention-guided strategy plus OMT versus OMT alone. The primary endpoint was a composite of all-cause mortality and non-fatal myocardial reinfarction at 1 year. Ethics approval was obtained by the institutional review board of every recruiting centre.
Results
From May 2014 to September 2018, 251 patients (n=125 invasive vs n=126 conservative) were enrolled. Almost 50% of participants were female. The trial was terminated prematurely due to slow recruitment. A Kaplan-Meier estimate of event-free survival revealed no difference in the primary endpoint at 1 year (invasive 18.5% [23/124] vs conservative 22.2% [28/126]; p=0.39). No significant difference persisted after Cox proportional hazards regression analysis (hazard ratio 0.79, 95% confidence interval 0.45-1.35; p=0.39). There was greater freedom from angina at 3 months (p<0.001) after early intervention but this was similar at 1 year. Both non-fatal reinfarction (invasive 9.7% [12/124] vs conservative 14.3% [18/126]; p=0.22) and unplanned revascularisation (invasive 1.6% [2/124] vs conservative 6.4% [8/126]; p=0.10) occurred more frequently in the OMT alone cohort.
Conclusions
An intervention-guided strategy was not superior to OMT alone to treat very elderly NSTEMI patients. The trial was underpowered to demonstrate this definitively. Early intervention resulted in fewer cases of reinfarction and unplanned revascularisation but did not improve survival.



EuroIntervention: 16 May 2021; 17:67-74
de Belder A, Myat A, Blaxill J, Haworth P, ... Robinson DR, Hildick-Smith D
EuroIntervention: 16 May 2021; 17:67-74 | PMID: 33226000
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Impact:
Abstract

Artificial intelligence and optical coherence tomography for the automatic characterisation of human atherosclerotic plaques.

Chu M, Jia H, Gutiérrez-Chico JL, Maehara A, ... Holm NR, Tu S
Background
Intravascular optical coherence tomography (IVOCT) enables detailed plaque characterisation in vivo, but visual assessment is time-consuming and subjective.
Aims
This study aimed to develop and validate an automatic framework for IVOCT plaque characterisation using artificial intelligence (AI).
Methods
IVOCT pullbacks from five international centres were analysed in a core lab, annotating basic plaque components, inflammatory markers and other structures. A deep convolutional network with encoding-decoding architecture and pseudo-3D input was developed and trained using hybrid loss. The proposed network was integrated into commercial software to be externally validated on additional IVOCT pullbacks from three international core labs, taking the consensus among core labs as reference.
Results
Annotated images from 509 pullbacks (391 patients) were divided into 10,517 and 1,156 cross-sections for the training and testing data sets, respectively. The Dice coefficient of the model was 0.906 for fibrous plaque, 0.848 for calcium and 0.772 for lipid in the testing data set. Excellent agreement in plaque burden quantification was observed between the model and manual measurements (R2=0.98). In the external validation, the software correctly identified 518 out of 598 plaque regions from 300 IVOCT cross-sections, with a diagnostic accuracy of 97.6% (95% CI: 93.4-99.3%) in fibrous plaque, 90.5% (95% CI: 85.2-94.1%) in lipid and 88.5% (95% CI: 82.4-92.7%) in calcium. The median time required for analysis was 21.4 (18.6-25.0) seconds per pullback.
Conclusions
A novel AI framework for automatic plaque characterisation in IVOCT was developed, providing excellent diagnostic accuracy in both internal and external validation. This model might reduce subjectivity in image interpretation and facilitate IVOCT quantification of plaque composition, with potential applications in research and IVOCT-guided PCI.



EuroIntervention: 16 May 2021; 17:41-50
Chu M, Jia H, Gutiérrez-Chico JL, Maehara A, ... Holm NR, Tu S
EuroIntervention: 16 May 2021; 17:41-50 | PMID: 33528359
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Impact:
Abstract

Clinical Outcomes of Proximal Optimization Technique (POT) in Bifurcation Stenting.

Chevalier B, Mamas MA, Hovasse T, Rashid M, ... Roguin A, Stankovic G
Background
Optimal deployment of coronary stents in a bifurcation lesion remains a matter of debate.
Aims
We sought to capture the daily practice of bifurcation stenting by means of a worldwide registry and to investigate how the post-implantation deployment techniques influence the clinical outcomes.
Methods
Data from the e-ULTIMASTER registry were used to perform an analysis of 4395 patients undergoing percutaneous coronary intervention for bifurcation lesions. Inverse probability of treatment weights (IPTW) propensity score methodology was used to adjust for any baseline differences. The primary outcome of interest was target lesion failure (TLF) at 1-year (follow-up rate 96.2%).
Results
Global one-year TLF rate was low: 5.1%. Proximal optimization technique was used in 33.9 % of cases and was associated with a reduction in adjusted TLF rate [4.0 (95% confidence interval:3.0-5.1)% versus 6.0(5.1-6.9)%, p&lt;0.01] due to a reduction of all components of this composite endpoint, except for cardiac death. Stent thrombosis was also positively impacted [0.4(0.04-0.7)% versus 1.3(0.8-1.7)%, p&lt;0.01]. POT benefit was uniform across subgroups. Conversely, the use of kissing balloon technique (36.5%) did not influence the adjusted TLF rate.
Conclusions
Despite a low one-year failure rate in this large bifurcation stenting cohort, proximal optimization technique was associated with a further reduction in the event rate and a uniform benefit across subgroups suggesting systematic use of this deployment technique regardless of the bifurcation anatomy and stenting technique.



EuroIntervention: 10 May 2021; epub ahead of print
Chevalier B, Mamas MA, Hovasse T, Rashid M, ... Roguin A, Stankovic G
EuroIntervention: 10 May 2021; epub ahead of print | PMID: 33970107
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Impact:
Abstract

Outcomes of transcatheter tricuspid valve intervention by right ventricular function: a multicentre propensity-matched analysis.

Schlotter F, Miura M, Kresoja KP, Alushi B, ... Taramasso M, Lurz P
Background
Tricuspid regurgitation (TR) has a poor prognosis and limited treatment options and is frequently accompanied by right ventricular (RV) dysfunction. Transcatheter tricuspid valve interventions (TTVI) to reduce TR have been shown to be safe and feasible with encouraging early results. Patient selection for TTVI remains challenging, with the role of right ventricular (RV) function being unknown.
Aims
The aims of this study were 1) to investigate survival in a TTVI-treated patient population and a conservatively treated TR population, and 2) to evaluate the outcome of TTVI as compared to conservative treatment stratified according to the degree of RV function.
Methods
We studied 684 patients from the multicentre TriValve cohort (TTVI cohort) and compared them to 914 conservatively treated patients from two tertiary care centres. Propensity matching identified 213 pairs of patients with severe TR. As we observed a non-linear relationship of RV function and TTVI outcome, we stratified patients according to tricuspid annular plane systolic excursion (TAPSE) to preserved (TAPSE &gt;17 mm), mid-range (TAPSE 13-17 mm) and reduced (TAPSE &lt;13 mm) RV function. The primary outcome was one-year all-cause mortality.
Results
TTVI was associated with a survival benefit in patients with severe TR when compared to matched controls (one-year mortality rate: 13.1% vs 25.8%; p=0.031). Of the three RV subgroups, only in patients with mid-range RV function was TTVI associated with an improved survival (p log-rank 0.004). In these patients, procedural success was associated with a reduced hazard ratio for all-cause mortality (HR 0.22; 95% CI: 0.09, 0.57).
Conclusions
TTVI is associated with reduced mortality compared to conservative therapy and might exert its highest treatment effect in patients with mid-range reduced RV function.



EuroIntervention: 04 May 2021; epub ahead of print
Schlotter F, Miura M, Kresoja KP, Alushi B, ... Taramasso M, Lurz P
EuroIntervention: 04 May 2021; epub ahead of print | PMID: 33956637
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Impact:
Abstract

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

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



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

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

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



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

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

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



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

Lipid-lowering therapy and percutaneous coronary interventions.

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



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

A Deep-Learning Algorithm for Detecting Acute Myocardial Infarction.

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



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

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

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



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

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

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



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

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

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



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

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

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



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

Statistical methods for composite endpoints.

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



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

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

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



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

Optimising physiological endpoints of percutaneous coronary intervention.

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



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

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

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



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

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

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



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

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

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



EuroIntervention: 18 Mar 2021; 16:1359-1365
Jobs A, Grund S, de Waha-Thiele S, Ledwoch J, ... Eitel I, Thiele H
EuroIntervention: 18 Mar 2021; 16:1359-1365 | PMID: 33046436
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This program is still in alpha version.