Journal: EuroIntervention

Sorted by: date / impact
Abstract

Impact of Pulmonary Ridge Coverage after Left Atrial Appendage Occlusion.

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



EuroIntervention: 09 Nov 2020; epub ahead of print
Freixa X, Cepas-Guillen P, Flores-Umanzor E, Regueiro A, ... Sitges M, Sabaté M
EuroIntervention: 09 Nov 2020; epub ahead of print | PMID: 33164895
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Abstract

Continuous intracoronary versus 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
The aim of this study was to evaluate the accuracy of a continuous intracoronary (IC) adenosine infusion, administered through the novel HYPEREM™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 three 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 the 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: 17 Sep 2020; 16:560-567
Elghamaz A, Myat A, de Belder A, Collison D, ... Stone GW, Oldroyd K
EuroIntervention: 17 Sep 2020; 16:560-567 | PMID: 31289017
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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
The aim of this study is to demonstrate the non-inferiority of the BiOSS LIM C sirolimus-eluting cobalt-chromium bifurcation dedicated stent against the XIENCE stent regarding the patient-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, multicentre study enrolling 260 patients (SYNTAX score ≤32) with a pre-specified performance goal based on the results of the EXCEL trial with contemporary percutaneous coronary intervention (PCI) for LMCA disease. Patient enrolment will comply with objective inclusion criteria of diameter stenosis ≥50% in the LMCA based on off-line quantitative coronary angiography (QCA) analysed by an independent core laboratory using dedicated bifurcation QCA software. The BiOSS LIM C is used for the treatment of LMCA disease with the same specific technical classification as for the BiOSS LIM (modified MADS classification) and the stent implantation is optimised by using pre-specified intravascular ultrasound criteria. The primary endpoint is POCE (a composite of all-cause death, stroke, any myocardial infarction, and any revascularisation) at 12 months.
Conclusions
The POLBOS LM study will indicate the efficacy of the 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: 22 Oct 2020; 16:654-662
Asano T, Kogame N, Onuma Y, Modolo R, ... Serruys PW, Gil RJ
EuroIntervention: 22 Oct 2020; 16:654-662 | PMID: 31543500
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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, reliable assessment of 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, and Pd/Pa were measured by the translesional 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=∆P/APV, where ∆P=translesional 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.
Conclusions
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 limit 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: 17 Sep 2020; 16:577-583
Modi BN, Rahman H, Ryan M, Ellis H, ... Chowienczyk P, Perera D
EuroIntervention: 17 Sep 2020; 16:577-583 | PMID: 31543499
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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
The aim of this study was 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, multicentre, open-label, randomised trial, investigating the impact of the experimental strategy (one-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus the reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) in patients with a Biolimus A9-eluting stent (BES). The primary endpoint was the composite of 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; the fourth quartile group was at significantly higher ischaemic risk at two years. In that stratum (TSL ≥46 mm), 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 could potentially balance ischaemic and bleeding risks, thereby achieving a net clinical benefit in patients with a TSL ≥46 mm with a BES.



EuroIntervention: 22 Oct 2020; 16:634-644
Takahashi K, Chichareon P, Modolo R, Kogame N, ... Windecker S, Serruys PW
EuroIntervention: 22 Oct 2020; 16:634-644 | PMID: 31498113
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Abstract

Fractional flow reserve-guided PCI in patients with and without left ventricular hypertrophy: a DANAMI-3-PRIMULTI substudy.

Sabbah M, Nepper-Christensen L, Lønborg J, Helqvist S, ... Kelbæk H, Engstrøm T
Aims
The aim of this substudy was to investigate the correlation between fractional flow reserve (FFR) and diameter stenosis in patients with STEMI with and without left ventricular hypertrophy (LVH), and the influence of LVH on complete FFR-guided revascularisation versus culprit only, in terms of risk of clinical outcome.
Methods and results
In this DANAMI-3-PRIMULTI substudy, 279 patients with STEMI had cardiac magnetic resonance (CMR) imaging for assessment of left ventricular mass index. Ninety-six patients had FFR evaluation of a non-culprit lesion. Diameter stenosis of the non-culprit lesion was determined with two-dimensional quantitative coronary analysis. The diameter stenosis (56.9% vs 54.3%, p=0.38) and FFR value (0.83 vs 0.85, p=0.34) were significantly correlated in both groups (Spearman\'s ρ=-0.40 and -0.41 without LVH and with LVH, respectively; p<0.001) but were not different between patients without and with LVH (p for interaction=0.87). FFR-guided complete revascularisation was associated with reduced risk of death, myocardial infarction or ischaemia-driven revascularisation both for patients without LVH (HR 0.42, 95% CI: 0.20-0.85) and for patients with LVH (HR 0.50, 95% CI: 0.17-1.47), with no interaction between the FFR-guided complete revascularisation and LVH (p for interaction=0.82).
Conclusions
LVH did not interact with the correlation between diameter stenosis and FFR and did not modify the impact of complete revascularisation on the occurrence of subsequent clinical events.



EuroIntervention: 17 Sep 2020; 16:584-590
Sabbah M, Nepper-Christensen L, Lønborg J, Helqvist S, ... Kelbæk H, Engstrøm T
EuroIntervention: 17 Sep 2020; 16:584-590 | PMID: 31746761
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Abstract

Diagnostic performance of intracoronary optical coherence tomography-based versus angiography-based fractional flow reserve for the evaluation of coronary lesions.

Huang J, Emori H, Ding D, Kubo T, ... Wijns W, Tu S
Aims
The aim of this study was to evaluate the diagnostic performance of OCT-based optical flow ratio (OFR) in unselected patients and compare it with angiography-based quantitative flow ratio (QFR), using wire-based FFR as reference standard.
Methods and results
All patients with OCT and FFR assessment prior to revascularisation were analysed. OFR and QFR were computed in a blinded fashion and compared with FFR, applying the same cut-off value of ≤0.80 to all to define ischaemia. Paired comparison between OFR and QFR was performed in 212 vessels from 181 patients. Average FFR was 0.82±0.10 and 40.1% of vessels had an FFR ≤0.80. OFR showed a significantly better correlation and agreement with FFR than QFR (r=0.87 versus 0.77, p<0.001; SD of the difference=0.05 versus 0.07, p<0.001). The AUC was 0.97 for OFR, higher than for QFR (difference=0.05, p=0.017), and much higher than the minimal lumen area (difference=0.15, p<0.001) and diameter stenosis (difference=0.17, p<0.001). Diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio for OFR to identify FFR ≤0.80 were 92%, 86%, 95%, 92%, 91%, 18.2 and 0.2, respectively. The diagnostic accuracy of OFR was not significantly different in MI-related vessels (95% versus 90%, p=0.456), or in vessels with and without previously implanted stents (90% versus 93%, p=0.669).
Conclusions
OFR had an excellent agreement with FFR in consecutive patients with coronary artery disease. OFR was superior to QFR, and much better than conventional morphological parameters in determining physiological significance of coronary stenosis. The diagnostic performance of OFR was not influenced by the presence of prior myocardial infarction or implanted stents.



EuroIntervention: 17 Sep 2020; 16:568-576
Huang J, Emori H, Ding D, Kubo T, ... Wijns W, Tu S
EuroIntervention: 17 Sep 2020; 16:568-576 | PMID: 31951207
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Abstract

Asia Pacific consensus document on coronary bifurcation interventions.

Loh PH, Lassen JF, Jepson N, Koo BK, ... Whelan A, Low A

Coronary bifurcation intervention is common but complex. Progress in this field has been made in recent years with considerable contribution from the Asia Pacific (APAC) region. However, the standard of practice varies across the APAC region due to differences in culture, socioeconomic state and healthcare set-up. Practice may also differ from the rest of the world. Hence, a panel of experts was invited to discuss topics relevant to bifurcation intervention in order to make a concerted effort to achieve consensus that is applicable within the region and in line with available evidence.



EuroIntervention: 08 Oct 2020; 16:e706-e714
Loh PH, Lassen JF, Jepson N, Koo BK, ... Whelan A, Low A
EuroIntervention: 08 Oct 2020; 16:e706-e714 | PMID: 32250248
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Abstract

Effectiveness of additional X-ray protection devices in reducing scattered radiation in radial intervention: the ESPRESSO randomised trial.

Anadol R, Brandt M, Merz N, Knorr M, ... Münzel T, Gori T
Aims
We aimed to examine the impact of three different radiation protection devices in a real-world setting of radial artery catheterisation.
Methods and results
In an all-comer randomised trial, consecutive coronary radial diagnostic and intervention procedures were assigned in a 1:1:1 ratio to shield-only protection (shield group), shield and overlapping 0.5 mm Pb panel curtain (shield+curtain group) or shield, curtain and additional 75x40 cm, 0.5 mm Pb drape placed across the waist of the patient (shield+curtain+drape group). A total of 614 radial procedures were randomised (n=193 shield, n=220 shield+curtain, n=201 shield+curtain+drape). There were no differences among the groups in patient or procedural characteristics. The primary endpoint (relative exposure ratio between the operators\' exposure in μSv and the patient\'s exposure, dose area product in cGy·cm2) was significantly lower in the shield+curtain+drape group for both the first operator (20% reduction vs shield, 16% vs shield+curtain, p=0.025) and the assistant (39% reduction vs shield, 25% vs shield+curtain, p=0.009).
Conclusions
The use of an additional drape reduced the radiation exposure of both the first operator and the second operator during routine radial procedures; a shield-attached curtain alone was only partially effective. ClinicalTrials.gov identifier: NCT03634657 Visual summary. X-ray protection devices and their effects on radiation exposure.



EuroIntervention: 22 Oct 2020; 16:663-671
Anadol R, Brandt M, Merz N, Knorr M, ... Münzel T, Gori T
EuroIntervention: 22 Oct 2020; 16:663-671 | PMID: 32338611
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Abstract

Hinge point-based annular plane with abnormal aortic cusps in transcatheter aortic valve replacement.

Pasala TKR, Jelnin V, Sahyoun C, Dudiy Y, Ruiz CE

A virtual aortic annular plane that is built using the three hinge points, known as the hinge point-based annular plane (HPAP), is routinely used during transcatheter aortic valve replacement (TAVR). Abnormal aortic cusps (AAC) with unequal length and size influence the relationship of the HPAP to the aortic root axis significantly and pose challenges to valve deployment, leading to paravalvular leak and valve embolisation. Obtaining a centreline-based aortic annular plane in addition may help to understand valve deployment behaviour in AAC better.



EuroIntervention: 17 Sep 2020; 16:549-553
Pasala TKR, Jelnin V, Sahyoun C, Dudiy Y, Ruiz CE
EuroIntervention: 17 Sep 2020; 16:549-553 | PMID: 32364500
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Abstract

A randomised comparison of monoplane versus biplane fluoroscopy in patients undergoing percutaneous coronary intervention: the RAMBO trial.

Leistner DM, Schlender LS, Steiner J, Erbay A, ... Landmesser U, Stähli BE
Aims
Interventional cardiologists are exposed to substantial occupational ionising radiation. This study sought to investigate differences in radiation exposure in biplane versus monoplane coronary angiography and percutaneous coronary interventions (PCI).
Methods and results
RAMBO (RAdiation exposure in Monoplane versus Biplane cOronary angiography and interventions) was a prospective, randomised, two-arm, single-centre, open-label trial, enrolling a total of 430 patients undergoing coronary angiography. Patients were randomly assigned to biplane or monoplane imaging. The primary efficacy measure, the operator radiation dose at the level of the left arm as measured by a wearable electronic dosimeter, was significantly higher in the biplane as compared to the monoplane group (4 [1-13] µSv vs 2 [0-6.8] µSv, p<0.001). The dose area product was 11,955 (7,095-18,246) mGy*cm2 and 8,349 (5,851-14,159) mGy*cm2 in the biplane and the monoplane groups, respectively (p<0.001). While fluoroscopy time did not differ between the groups (p=0.89), the amount of contrast medium was lower with biplane as compared with monoplane imaging (p<0.001).
Conclusions
Biplane imaging for coronary angiography and PCI is related to an increased radiation exposure for the interventional cardiologist as compared with monoplane imaging. Monoplane imaging should be considered for advanced radioprotection in cardiac catheterisation, with biplane imaging used for selected cases only. Visual summary. RAdiation exposure in Monoplane versus Biplane percutaneous cOronary angiography and interventions: the RAMBO trial.



EuroIntervention: 22 Oct 2020; 16:672-679
Leistner DM, Schlender LS, Steiner J, Erbay A, ... Landmesser U, Stähli BE
EuroIntervention: 22 Oct 2020; 16:672-679 | PMID: 32392169
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Abstract

Systematic review and meta-analysis of valve-in-valve transcatheter aortic valve replacement in patients with failed bioprosthetic aortic valves.

Mahmoud AN, Gad MM, Elgendy IY, Mahmoud AA, ... Kapadia SR, Dvir D
Aims
The aim of this meta-analysis was to evaluate the evidence regarding the rates of procedural success and the incidence of adverse outcomes following valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) in patients with failed bioprosthetic aortic valves.
Methods and results
A systematic search of major electronic databases was conducted for studies relevant to patients with failed bioprosthetic aortic valves undergoing VIV-TAVR. The primary outcome was procedural success. A total of 5,553 patients from 24 studies were included. The mean Society of Thoracic Surgeons (STS) score was 7.84±5.14. The procedural success rate was high (97%, 95% confidence interval [CI]: 94-98%). At 30 days, all-cause mortality was 5% (95% CI: 3-6%), stroke 2% (95% CI: 1-2%), myocardial infarction 1% (95% CI: 1-2%), permanent pacemaker placement 6% (95% CI: 5-8%), and aortic regurgitation 7% (95% CI: 5-10%). At one year, the incidence of all-cause mortality was 12% (95% CI: 10-14%), stroke 3% (95% CI: 2-4%), myocardial infarction 1% (95% CI: 0-2%), and permanent pacemaker placement 7% (95% CI: 5-11%). At three years, the incidence of all-cause mortality was 29% (95% CI: 25-34%) and stroke 6% (95% CI: 5-9%).
Conclusions
VIV-TAVR appears to be associated with high procedural success rates and low adverse outcomes during the short-term and midterm follow-up period.



EuroIntervention: 17 Sep 2020; 16:539-548
Mahmoud AN, Gad MM, Elgendy IY, Mahmoud AA, ... Kapadia SR, Dvir D
EuroIntervention: 17 Sep 2020; 16:539-548 | PMID: 32420881
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Abstract

Bioresorbable vascular scaffold versus metallic drug-eluting stent in patients at high risk of restenosis: the COMPARE-ABSORB randomised clinical trial.

Smits PC, Chang CC, Chevalier B, West NEJ, ... Onuma Y, van Geuns RM
Aims
The aim of this study was to investigate clinical outcomes of patients at high risk of restenosis after implantation of a bioresorbable vascular scaffold (BVS).
Methods and results
The COMPARE-ABSORB trial was an investigator-initiated, prospective randomised study. Patients at high risk of restenosis were randomly assigned to receive either a BVS or an everolimus-eluting stent (EES). A dedicated implantation technique was recommended for BVS. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically indicated target lesion revascularisation at one year. The enrolment was discontinued prematurely because of a high thrombosis and TVMI rate in the BVS arm. A total of 1,670 patients were recruited (BVS 848 patients and EES 822 patients). TLF occurred in 43 patients (5.1%) of the BVS group and 34 patients (4.2%) of the EES group (absolute difference 0.9%, 95% confidence interval [CI]: -1.2%-3.0%, p non-inferiority <0.001). Definite or probable device thrombosis (2.0% vs 0.6%, hazard ratio [HR] 3.32, 95% CI: 1.22-8.99, p=0.012) and TVMI (4.0% vs 2.1%, HR 1.96, 95% CI: 1.10-3.51, p=0.02) were significantly higher in the BVS group than in the EES group.
Conclusions
In patients at high risk of restenosis, non-inferiority of BVS compared with EES in terms of TLF was met at one year. BVS carried a higher risk of device thrombosis and TVMI than EES.



EuroIntervention: 22 Oct 2020; 16:645-653
Smits PC, Chang CC, Chevalier B, West NEJ, ... Onuma Y, van Geuns RM
EuroIntervention: 22 Oct 2020; 16:645-653 | PMID: 32451321
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Abstract

Left atrial appendage closure versus medical therapy in patients with atrial fibrillation: the APPLY study.

Gloekler S, Fürholz M, de Marchi S, Kleinecke C, ... Windecker S, Meier B
Aims
Left atrial appendage closure (LAAC) with AMPLATZER occluders is used for stroke prevention in atrial fibrillation (AF). Net clinical benefit compared to medical therapy has not been tested. The aim of this study was to test whether long-term clinical outcome after LAAC with AMPLATZER occluders may be similar to medical therapy.
Methods and results
Five hundred consecutive patients who underwent LAAC with AMPLATZER occluders were compared to 500 patients with medical therapy by propensity score matching. The primary efficacy endpoint was a composite of stroke, systemic embolism and cardiovascular/unexplained death. The primary safety endpoint consisted of major procedural adverse events and major bleedings. For assessment of net clinical benefit, all of the above-mentioned hazards were combined. After 2,645 patient-years at a mean follow-up of 2.7±1.5 years, the primary efficacy endpoint was reached by 75/1,342, 5.6% in the LAAC group versus 102/1,303, 7.8% per 100 patient-years (hazard ratio [HR] 0.70, 95% confidence interval [CI]: 0.53-0.95, p=0.026). The primary safety endpoint occurred in 48/1,342, 3.6% versus 60/1,303, 4.6% per 100 patient-years (HR 0.80, 95% CI: 0.55-1.18, p=0.21), and the combined hazard endpoint in 109/1,342, 8.1% versus 142/1,303, 10.9% per 100 patient-years (HR 0.76, 95% CI: 0.60-0.97, p=0.018). Patients receiving LAAC demonstrated lower rates of both all-cause and cardiovascular mortality (111/1,342, 8.3% vs 151/1,303, 11.6% per 100 patient-years [HR 0.72, 95% CI: 0.56-0.92, p=0.005] and 54/1,342, 4.0% vs 84/1,303, 6.5% per 100 patient-years [HR 0.64, 95% CI: 0.46-0.89, p=0.007]).
Conclusions
LAAC with AMPLATZER devices showed a net clinical benefit over medical therapy by superior efficacy, similar safety and a benefit in all-cause and cardiovascular mortality.



EuroIntervention: 08 Oct 2020; 16:e767-774
Gloekler S, Fürholz M, de Marchi S, Kleinecke C, ... Windecker S, Meier B
EuroIntervention: 08 Oct 2020; 16:e767-774 | PMID: 32583806
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Abstract

Impact of coronary lesion complexity in percutaneous coronary intervention: one-year outcomes from the large, multicentre e-Ultimaster registry.

Mohamed MO, Polad J, Hildick-Smith D, Bizeau O, ... Angioi M, Mamas MA
Aims
The present study sought to examine the prevalence, clinical characteristics and one-year outcomes of patients undergoing percutaneous coronary intervention (PCI) to complex lesions (multivessel PCI, ≥3 stents, ≥3 lesions, bifurcation with ≥2 stents, total stent length >60 mm or chronic total occlusion [CTO]) in a prospective multicentre registry.
Methods and results
Using the e-Ultimaster multicentre registry, a post hoc subgroup analysis was performed on 35,839 patients undergoing PCI, stratified by procedure complexity, and further by number and type of complex features. Overall, complex PCI patients (n=9,793, 27.3%) were older, more comorbid and were associated with an increased hazard ratio (HR) of the composite endpoint at one year (target lesion failure [TLF]: 1.41 [1.25; 1.59]), driven by an increased hazard of cardiac death (1.28 [1.05; 1.55]), target vessel myocardial infarction (1.48 [1.18; 1.86]) and clinically driven target lesion revascularisation. The hazard of complications increased with the rising number of complex features (3-6 vs 1-2 vs none) for all outcomes. All individual complex features were associated with an increased hazard of composite complications (except CTO) and definite/probable stent thrombosis.
Conclusions
Overall, complex PCI is associated with an increased risk of mortality and complications at one year. The number and types of complex features have differing impacts on long-term outcomes.



EuroIntervention: 17 Sep 2020; 16:603-612
Mohamed MO, Polad J, Hildick-Smith D, Bizeau O, ... Angioi M, Mamas MA
EuroIntervention: 17 Sep 2020; 16:603-612 | PMID: 32588821
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Abstract

Systematic use of intentional leaflet laceration to prevent TAVI-induced coronary obstruction: feasibility and early clinical outcomes of the BASILICA technique.

Kitamura M, Majunke N, Holzhey D, Desch S, ... Thiele H, Abdel-Wahab M
Aims
The aim of this study was to evaluate the feasibility, efficacy and safety of the bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) technique during transcatheter aortic valve implantation (TAVI) in an initial cohort at a single European centre.
Methods and results
Between August 2018 and March 2020, BASILICA was attempted in 23 leaflets in 21 consecutive patients undergoing TAVI (age 78±6 years, 52% female). The index procedure was performed for 21 degenerated bioprosthetic leaflets (90%, 9.2±2.6 years after implantation) and two native leaflets (10%). BASILICA was performed for a single leaflet in 19 (90%) patients and for both leaflets in two (10%) patients. The median total procedure time was 82 (interquartile range [IQR] 70-131) minutes, and BASILICA time (sheath-in to laceration) was 45 (IQR 35-67) minutes. A cerebral embolic protection device was used in 20 (95%) patients. BASILICA was feasible in all but one patient (95%) and resulted in effective prevention of coronary obstruction in 19 patients (90%). One patient developed a non-flow-limiting ostial lesion after BASILICA and TAVI, and was treated by additional coronary stenting. No mortality or stroke was observed up to 30 days.
Conclusions
The feasibility, efficacy and safety of BASILICA in this early single-centre experience were consistent with the initial proof-of-concept reports. Further validation by ongoing multicentre registries remains warranted. Visual summary. The Leipzig BASILICA experience.



EuroIntervention: 22 Oct 2020; 16:682-690
Kitamura M, Majunke N, Holzhey D, Desch S, ... Thiele H, Abdel-Wahab M
EuroIntervention: 22 Oct 2020; 16:682-690 | PMID: 32597392
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Impact:
Abstract

Percutaneous mitral valve leaflet repair: ongoing directions and future perspectives.

Maisano F, Taramasso M

Percutaneous mitral valve leaflet repair has revolutionised the treatment of heart failure patients with secondary mitral regurgitation. It also offers a valuable alternative to surgery for high-risk patients with degenerative disease. More than one device is now available for leaflet repair, broadening the indications and improving outcomes, as well as complicating the decision-making algorithms. In the last two years, several trials and registries have enriched the evidence around these procedures, although many questions remain open. Two major clinical trials have provided opposing evidence, confirming that this field of cardiovascular medicine remains controversial. Probably, the challenge remains with the human factor: achieving optimal outcomes remains a challenge, highly dependent on patient selection, timing and procedural details. Operator-dependent factors are emerging as a key element, not unexpectedly, to achieve procedural excellence. Besides large randomised controlled trials, a great deal of knowledge is emerging from real-world registries. This review focuses on what we can learn from registries and single-centre experiences as a complement to the large randomised trials.



EuroIntervention: 19 Nov 2020; 16:803-807
Maisano F, Taramasso M
EuroIntervention: 19 Nov 2020; 16:803-807 | PMID: 33046435
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Impact:
Abstract

Transaxillary compared with transcarotid access for TAVR: a propensity-matched comparison from a French multicentre registry.

Debry N, Trimech TR, Gandet T, Vincent F, ... Modine T, Van Belle E
Aims
No randomised study comparing the outcomes of transcarotid (TC) and transaxillary (TAx) TAVR has been conducted to date. The purpose of this study was to understand which approach should be the preferred alternative by comparing their outcomes using a propensity-matched comparison in a French multicentre registry.
Methods and results
From 2010 to 2018, a French multicentre prospective registry included 502 patients, with 374 undergoing TC-TAVR and 128 TAx-TAVR for symptomatic aortic stenosis. Patients treated through TAx access were matched 1:2 with patients treated through the TC route by using a propensity score (20 clinical, anatomical and procedural variables) and by date of the procedure. The first outcome was mortality at one-month follow-up. The second outcome was one-month stroke/transient ischaemic attack (TIA). In propensity-matched analyses, the incidence of the primary outcome was similar in the TAx and TC groups (TAx 5.5% vs TC 4.5%, OR 1.23, 95% CI: 0.40-3.70). The secondary outcome was similar in TAx (3.2%) and TC (6.8%, OR 0.52, 95% CI: 0.14-1.84). Minor bleeding (2.7% vs 9.3%, OR 0.26, 95% CI: 0.07-0.92) and main access haematoma (3.6% vs 10.3%, OR 0.034, 95% CI: 0.09-0.92) were significantly more frequent with the TC access. One-month clinical efficacy and safety and one-year mortality did not differ according to the different routes.
Conclusions
One-month mortality, one-month stroke/TIA and one-year mortality are similar with TAx-TAVR and TC-TAVR. However, TC-TAVR is accompanied by more minor bleeding and main access haematoma compared with the transaxillary route.



EuroIntervention: 19 Nov 2020; 16:842-849
Debry N, Trimech TR, Gandet T, Vincent F, ... Modine T, Van Belle E
EuroIntervention: 19 Nov 2020; 16:842-849 | PMID: 32310129
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Impact:
Abstract

Double-kissing culotte technique for coronary bifurcation stenting.

Toth GG, Sasi V, Franco D, Prassl AJ, ... Wijns W, Barbato E
Aims
The aim of this study was to assess whether the culotte technique could be improved by an additional kissing dilation prior to main branch (MB) stenting.
Methods and results
Double-kissing (DK) culotte was compared to the culotte and DK-crush techniques in a bench model (n=24). Results were evaluated for stent apposition, luminal opening and flow dynamics. The total procedure duration of DK-culotte was 18.3±3.4 minutes, significantly lower than for DK-crush (24.3±5.7 min; p=0.015), but similar to culotte (21.6±5.9 min, p=0.104). In DK-culotte the overall rate of moderate (200-500 µm) and significant (>500 µm) malapposition was 2.1±1.9% and 0.4±0.2%, similar as compared to culotte (3.7±3.8%, p=0.459 and 1.0±1.0%, p=0.517, respectively), and lower as compared to DK-crush (8.1±2.5%, p<0.001 and 3.7±5.3%, p=0.002, respectively). The lower malapposition rate of DK-culotte as compared to DK-crush was due to less moderate and significant malapposition in the proximal MB (0.0±0.0% vs 14.0±7.6%, p<0.001 and 0.0±0.0% vs 4.2±9.1%, p=0.026, respectively). Micro-computed tomography did not show a difference in luminal opening at the proximal MB, distal MB or SB. There was no difference either in the maximum shear rate or in areas of high shear or recirculation.
Conclusions
Bench test data suggest that the DK approach facilitates the culotte technique. The clinical validity and relevance remain to be confirmed in a larger in vivo population.



EuroIntervention: 08 Oct 2020; 16:e724-e733
Toth GG, Sasi V, Franco D, Prassl AJ, ... Wijns W, Barbato E
EuroIntervention: 08 Oct 2020; 16:e724-e733 | PMID: 32338608
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Impact:
Abstract

Transcatheter edge-to-edge mitral valve repair with the PASCAL system: early results from a real-world series.

Besler C, Noack T, von Roeder M, Kitamura M, ... Thiele H, Lurz P
Aims
This study sought to characterise the real-world performance and clinical outcomes of the PASCAL system, a leaflet approximation device for transcatheter mitral valve repair.
Methods and results
Fifty patients in NYHA Class II-IV despite optimal medical therapy (median age 78.0 years [IQR 74.5-81.0], 52% female, log EuroSCORE 21.6 [IQR 13.2-30.2]) were treated for severe mitral regurgitation (MR) and followed up for one month. Primary and secondary MR was present in 24% and 68% of patients, respectively, with a mixed aetiology observed in 8%. A 1-device strategy was employed in 26/50 patients (52%), a 2-device strategy in 23/50 (46%) patients, and a 3-device strategy in 1/50 (2%) patients. Technical and procedural success was achieved in 100% and 98% of patients, respectively. MR grade ≤1 was observed in 39/50 (78%) patients at discharge, and in 36/46 (78%) patients at one month, with transvalvular gradients remaining ≤5 mmHg in all patients. One device embolisation and one single leaflet device attachment were observed during follow-up. After one month, 73% of patients reported an improvement in NYHA class, and six-minute walk test distance increased by 73±12 m in patients without relevant tricuspid regurgitation.
Conclusions
In a real-world population, the PASCAL device effectively reduces MR and leads to functional improvements on short-term follow-up. Visual summary. PASCAL system in mitral regurgitation.



EuroIntervention: 19 Nov 2020; 16:824-832
Besler C, Noack T, von Roeder M, Kitamura M, ... Thiele H, Lurz P
EuroIntervention: 19 Nov 2020; 16:824-832 | PMID: 32515739
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Impact:
Abstract

Clinical outcomes of TAVI or SAVR in men and women with aortic stenosis at intermediate operative risk: a post hoc analysis of the randomised SURTAVI trial.

Van Mieghem NM, Reardon MJ, Yakubov SJ, Heiser J, ... Serruys PW, Popma JJ
Aims
In patients with aortic stenosis randomised to transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR), sex-specific differences in complication rates are unclear in intermediate-risk patients. The purpose of this analysis was to identify sex-specific differences in outcome for patients at intermediate surgical risk randomised to TAVI or SAVR in the international Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial.
Methods and results
A total of 1,660 intermediate-risk patients underwent TAVI with a supra-annular, self-expanding bioprosthesis or SAVR. The population was stratified by sex and treatment modality (female TAVI=366, male TAVI=498, female SAVR=358, male SAVR=438). The primary endpoint was a composite of all-cause mortality or disabling stroke at two years. Compared to males, females had a smaller body surface area, a higher Society of Thoracic Surgeons score (4.7±1.6% vs 4.3±1.6%, p<0.01) and were more frail. Men required more concomitant revascularisation (23% vs 16%). All-cause mortality or disabling stroke at two years was similar between TAVI and SAVR for females (10.2% vs 10.5%, p=0.90) and males (14.5% vs 14.4%, p=0.99); the difference between females and males was 10.2% vs 14.5%, for TAVI (p=0.08) and 10.5% vs 14.4%, SAVR (p=0.13). Functional status improvement was more pronounced after TAVI in females than in males.
Conclusions
Aortic valve replacement, either by surgical or transcatheter approach, appears similarly effective and safe for males and females at intermediate surgical risk. Functional status appears to improve most in females after TAVI.
Clinical trial registration
http://clinicaltrials.gov NCT01586910.



EuroIntervention: 19 Nov 2020; 16:833-841
Van Mieghem NM, Reardon MJ, Yakubov SJ, Heiser J, ... Serruys PW, Popma JJ
EuroIntervention: 19 Nov 2020; 16:833-841 | PMID: 32715995
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Impact:
Abstract

Thirty-day clinical outcomes of the Evolut PRO self-expanding transcatheter aortic valve: the international FORWARD PRO study.

Manoharan G, Grube E, Van Mieghem NM, Brecker S, ... Fan Y, Windecker S
Aims
The Evolut PRO is a new transcatheter heart valve with an outer pericardial wrap intended to reduce paravalvular leak and facilitate tissue ingrowth. We aimed to evaluate the clinical performance and safety of the Evolut PRO valve in standard practice.
Methods and results
FORWARD PRO is a prospective, multinational, multicentre observational study. Transcatheter aortic valve implantation with the Evolut PRO valve (23, 26, or 29 mm) was attempted in 629 non-consecutive patients from 39 centres from February 2018 to January 2019. The primary endpoint was the rate of all-cause mortality at 30 days compared to a pre-specified performance goal. An independent clinical events committee adjudicated safety endpoints based on VARC-2 definitions. All echocardiograms were centrally assessed by an independent core laboratory (Mayo Clinic, Rochester, MN, USA). Baseline characteristics included mean age 81.7±6.1 years, 61.8% female, STS score 4.7±3.3%, and 33.6% were frail. All-cause mortality at 30 days was 3.2%, which was lower than the pre-specified performance goal of 5.5% (p=0.004). Greater than mild AR was present in 1.8% of patients at discharge.
Conclusions
The FORWARD PRO study confirmed the safety and efficacy of the Evolut PRO transcatheter aortic valve system with an external pericardial wrap. ClinicalTrials.gov Identifier: NCT03417011 Visual summary. Paravalvular leak at discharge and (right) the Evolut PRO valve (Medtronic) with external pericardial wrap. Reproduced with permission from Medtronic, Inc.



EuroIntervention: 19 Nov 2020; 16:850-857
Manoharan G, Grube E, Van Mieghem NM, Brecker S, ... Fan Y, Windecker S
EuroIntervention: 19 Nov 2020; 16:850-857 | PMID: 32748789
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Impact:
Abstract

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

Kroon H, von der Thusen JH, Ziviello F, van Wiechen M, ... de Jaegere P, Van Mieghem NM
Aims
To investigate the total amount, size and heterogeneity of debris captured among different transcatheter valve types and while repositioning.
Methods and results
A total of 328 patients who underwent transcatheter aortic valve implantation (TAVI) with Sentinel cerebral embolic protection (CEP) at our center were eligible. Histopathological and semiquantitative analysis of captured debris was performed and data was entered in our prospective database. TAVI was performed with either the Evolut R/PRO (N=123), Sapien3 (N=113) or Lotus valve (N=92). Capture of debris occurred in 98% of patients. Lotus TAVI resulted in more frequent foreign body material (62% vs. 40% vs. 47%, P=0.006), endothelium (49% vs. 30% vs. 16%, P<0.0005), calcified material (33% vs. 12% vs. 24%, P=0.001) and myocardial tissue (19% vs. 11% vs. 2%, P<0.0005) compared to Sapien3 or Evolut R/PRO. Native (functional) bicuspid valves (OR 2.91, 95% CI 1.20-7.03, P=0.02) and Lotus (OR 2.44, 95% CI 1.14-5.24, P=0.02) were associated with the highest risk for dislodging particles ≥1000um. Valve repositioning was independently associated with larger debris amounts (OR 2.96, 95% CI 1.42-6.16, P=0.004).
Conclusions
All THV platforms had similar amounts of captured debris. THV repositioning seemed associated with a higher risk for dislodging greater amounts of debris to the brain.



EuroIntervention: 07 Sep 2020; epub ahead of print
Kroon H, von der Thusen JH, Ziviello F, van Wiechen M, ... de Jaegere P, Van Mieghem NM
EuroIntervention: 07 Sep 2020; epub ahead of print | PMID: 32894232
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Impact:
Abstract

Twelve-month clinical and imaging outcomes of the uncaging DynamX Bioadaptor System.

Verheye S, Vrolix M, Montorfano M, Zivelonghi C, ... Abizaid AA, Colombo A
Aims
We assessed the safety and efficacy of the DynamX™ Novolimus-Eluting Coronary Bioadaptor System, a novel device that initially acts as a second-generation drug-eluting stent, but after six months frees the vessel through uncaging elements.
Methods and results
This multi-center study enrolled 50 patients with single de novo lesions. In-device acute lumen gain was 1.61±0.34 mm, and device and procedure success was 100%. Through 12 months, two target lesion failures occurred, both were cardiac deaths (day 255 and 267 post-procedure). No definite or probable device thrombosis was observed. Mean late lumen loss was 0.12±0.18 mm in-device and 0.11±0.16 mm in-segment. Per intravascular ultrasound, the mean device area and mean vessel area increased significantly by 5% and 3%, respectively, while the mean lumen area was maintained. Stationary optical coherence tomography in seven patients demonstrated restoration of cyclic pulsatility with an approximate lumen area variance of 11% between systole and diastole.
Conclusions
The DynamX bioadaptor showed drug-eluting stent-like acute performance and safety and efficacy through one year. Positive remodelling with an increase of vessel and device area while maintaining the mean lumen area was demonstrated. Long-term follow-up and randomized trials are required to assess the benefit of this device on events beyond one year.



EuroIntervention: 07 Sep 2020; epub ahead of print
Verheye S, Vrolix M, Montorfano M, Zivelonghi C, ... Abizaid AA, Colombo A
EuroIntervention: 07 Sep 2020; epub ahead of print | PMID: 32894231
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Impact:
Abstract

Clinical outcomes by optical characteristics of neointima and treatment modality in patients with coronary in-stent restenosis.

Xhepa E, Bresha J, Joner M, Hapfelmeier A, ... Alfonso F, Kastrati A
Aims
First, to assess the relation between neointimal pattern and clinical outcomes following in-stent restenosis (ISR) treatment; second, to explore a potential interaction between neointimal pattern and treatment modality relative to clinical outcomes.
Methods and results
Based on the distribution of non-homogeneous quadrants, patients undergoing optical coherence tomography (OCT) prior to drug-eluting stent (DES) or drug-coated balloon (DCB) treatment of ISR, were categorized in low and high inhomogeneity groups (100 and 97 patients respectively). There were no significant differences in terms of MACE (P=0.939) or TLR (P=0.732). The exploratory analysis showed a significant interaction between neointimal pattern and treatment modality regarding MACE (P int =0.006) and TLR (P int =0.022). DES showed a significant advantage over DCB in the high [MACE: HR 0.26 (0.10-0.65), P=0.004; TLR: HR 0.28 (0.11-0.69), P=0.006], but not in the low inhomogeneity group (MACE: P=0.917; TLR: P=0.797).
Conclusions
In patients with ISR treated with DCB or DES, there were no significant differences in terms of MACE or TLR between low and high inhomogeneity groups. A significant interaction was observed between treatment modality and neointimal pattern with an advantage of DES over DCB in the high and no difference in the low inhomogeneity group. This warrants confirmation from prospective dedicated studies.



EuroIntervention: 07 Sep 2020; epub ahead of print
Xhepa E, Bresha J, Joner M, Hapfelmeier A, ... Alfonso F, Kastrati A
EuroIntervention: 07 Sep 2020; epub ahead of print | PMID: 32894230
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Impact:
Abstract

Device entrapment during percutaneous coronary intervention of chronic total occlusions: Incidence and management strategies.

Gasparini GL, Sanz-Sanchez J, Regazzoli D, Boccuzzi G, ... Belli G, Garbo R
Aims
To describe the incidence, procedural characteristics and discuss management strategies of device entrapment in patients undergoing percutaneous coronary intervention (PCI) for chronic total occlusions (CTO).
Methods and results
Device entrapment was characterized in a large consecutive series of 2361 CTO PCI cases performed by five high-volume CTO Italian operators between January 2015 and January 2020. Device entrapment occurred in 36 out of 2361 cases (1.5%) and consisted of coronary guidewires in 13 (0.5%), microcatheters in 6 (0.2%), balloons in 6 (0.2%), rotational atherectomy burrs in 10 (0.4%) and guiding catheter extension in 1 patient (0.04%). Complete device retrieval was achieved in 63.9%, with at least partial removal of material in 97.2%. Vessel recanalization was still possible in 86.1% of cases even after device entrapment. Intraprocedural myocardial infarction occurred in 3 patients (8.3%); tamponade with urgent pericardiocentesis in one (2.8%) and emergency surgical removal of the entrapped device in one patient (2.8%). Mean radiation dose was 4.7±2.3 Gy. At 30-day follow-up, one patient died with stent thrombosis of a non-target vessel and another required repeat percutaneous revascularization.
Conclusions
Device entrapment during CTO revascularizations is a rare but potentially severe complication. We describe and discuss current techniques of percutaneous retrieval that can be employed to safely achieve procedural success.



EuroIntervention: 07 Sep 2020; epub ahead of print
Gasparini GL, Sanz-Sanchez J, Regazzoli D, Boccuzzi G, ... Belli G, Garbo R
EuroIntervention: 07 Sep 2020; epub ahead of print | PMID: 32894229
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Impact:
Abstract

Culprit lesion location and outcomes in patients with multi-vessel disease and infarct-related cardiogenic shock. A core laboratory analysis of the CULPRIT-SHOCK trial.

Hauguel-Moreau M, Barthélémy O, Farhan S, Huber K, ... Thiele H, Montalescot G
Aims
Critical culprit lesion locations (CCLL) such as left main (LM) and proximal left anterior descending (LAD) are associated with worse clinical outcome in myocardial infarction without cardiogenic shock (CS). We aimed to assess whether CCLL identifies a subgroup of patients at poorer prognosis when presenting with CS.
Methods and results
In the CULPRIT-SHOCK trial, a core-laboratory reviewed all coronary angiograms to identify CCLL. CCLL was defined as a culprit lesion realizing a >70% diameter stenosis of LM, LM equivalent (>70% diameter stenoses of both proximal LAD and proximal circumflex), proximal LAD or, last remaining vessel. We evaluated the primary study endpoint of the CULPRIT-SHOCK trial according to CCLL. A total of 269 (43%) out of 626 patients eligible for this analysis had a CCLL. Death or renal replacement therapy within 30 days, death within 30 days and within 1 year were significantly higher in CCLL than in non-CCLL group (58.4% vs. 43.4%, p<0.001, 55.8% vs . 39.5%, p<0.001, 61.0% vs. 44.5%, p<0.001, respectively). It was consistent after adjustment for baseline and angiographic characteristics. No interaction with the randomization group (culprit lesion-only or immediate multivessel PCI) was found.
Conclusions
CCLL is frequent in CS and independently associated with worse clinical outcome irrespective of the revascularization strategy.



EuroIntervention: 07 Sep 2020; epub ahead of print
Hauguel-Moreau M, Barthélémy O, Farhan S, Huber K, ... Thiele H, Montalescot G
EuroIntervention: 07 Sep 2020; epub ahead of print | PMID: 32894227
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Impact:
Abstract

A randomized controlled trial to compare the safety and efficacy of sirolimus-eluting biodegradable polymer ultra-thin stent (SUPRAFLEX Cruz) and everolimus-eluting biodegradable polymer stent (SYNERGY) in treatment for three-vessel coronary artery disease: design of the Multivessel TALENT trial.

Hara H, Gao C, Kogame N, Ono M, ... Onuma Y, Serruys PW
Aims
The purpose of the Multivessel TALENT trial is to compare clinical outcomes of novel SUPRAFLEX Cruz stent with those of SYNERGY stent in patients with three vessel disease (3VD) undergoing state-of-the-art percutaneous coronary intervention (PCI).
Methods and results
In this prospective, randomized, 1:1 balanced, multi-center, open-label trial, 1550 patients with de novo 3VD without left main disease are assigned to the SUPRAFLEX Cruz or SYNERGY arm. The following treatment principles of the \"best practice\" PCI will be applied: Heart Team consensus based on SYNTAX Score II treatment recommendation, functional lesion evaluation by quantitative flow ratio (QFR), stent optimization by intravascular imaging, optimal pharmacological treatment and prasugrel monotherapy. The primary endpoint is a non-inferiority comparison of patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any revascularization, at 12 months post-procedure. The powered secondary endpoint is a superiority comparison of vessel-oriented composite endpoint (VOCE) defined as vessel-related cardiovascular death, vessel-related myocardial infarction, or clinically and physiologically-indicated-target vessel revascularization, at 24 months.
Conclusions
The Multivessel TALENT trial will be evaluating a novel treatment strategy for complex coronary artery disease with state-of-the-art PCI based on angiography-derived QFR with novel ultra-thin SUPRAFLEX Cruz stents, compared with the SYNERGY stents.



EuroIntervention: 14 Sep 2020; epub ahead of print
Hara H, Gao C, Kogame N, Ono M, ... Onuma Y, Serruys PW
EuroIntervention: 14 Sep 2020; epub ahead of print | PMID: 32928717
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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 localized turbulent flow and enhanced propensity for platelet deposition, plaque rupture, and atherothrombosis. 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 ischemic 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 to analyze the currently available evidence. Although mainly derived from sub-studies of large trials or small studies, 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 here proposed.



EuroIntervention: 14 Sep 2020; epub ahead of print
Zimarino M, Angiolillo DJ, Dangas G, Capodanno D, ... Mehran R, Stankovic G
EuroIntervention: 14 Sep 2020; epub ahead of print | PMID: 32928716
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Impact:
Abstract

A computed tomography study of coronary access and coronary obstruction after redo transcatheter aortic valve implantation.

Buzzatti N, Montorfano M, Romano V, De Backer O, ... Colombo A, Latib A
Aims
To investigate the risk of impaired coronary access and coronary obstruction after REDO-TAVI.
Methods and results
Post-procedure multi-detector computed tomography (MDCT) scans of 221 TAVI recipients were analyzed. Increased risk of impaired coronary access was defined as coronary ostium below TAVI commissures with valve-to-aorta distance <2mm at this level. Increased risk was found in 123 (55.6%) cases, the left main involved in 109 (49.3%), the right coronary in 79 (35.7%), both in 65 (29.4%) patients. Small sino-tubular junction (STJ width OR 0.68, CI 0.56-0.81, P<0.001; STJ height OR 0.81, CI 0.69-0.95, P<0.011) and supra-annular devices (OR 19.8, CI 6.6-58.8, P<0.001) predicted increased risk. Increased risk of coronary obstruction defined as coronary ostium below TAVI commissures with valve-to-coronary distance <2mm was observed in 14.9% of patients, and in 17.2% of cases complete sealing of STJ would occur.
Conclusions
Post-TAVI MDCT suggested an increased potential risk of impaired coronary access in more than half of patients should REDO-TAVI be required, predicted by small STJ and supra-annular device design. Furthermore, 10-20% of patients presented an increased risk of coronary obstruction. While this theoretical study is hypothesis-generating, it raises concerns that need to be further investigated and addressed before TAVI is extended to patients with longer life expectancy.



EuroIntervention: 14 Sep 2020; epub ahead of print
Buzzatti N, Montorfano M, Romano V, De Backer O, ... Colombo A, Latib A
EuroIntervention: 14 Sep 2020; epub ahead of print | PMID: 32928715
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Impact:
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
Aims
The ability of optical coherence tomography (OCT) to identify specific types of stent has never been systematically studied.
Methods and results
A series of 212 consecutive patients with OCT from six international centres were retrospectively screened, finding 294 metallic stents or scaffolds in 146 patients. The sample was analysed by two blinded operators, applying a dedicated protocol in 4 steps to identify the type of stent: 1) 3D and automatic strut detection (ASD), 2) 3D in direct tissue view, 3) Longitudinal view with ASD, 4) Mode \"stent only\" and ASD. 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 18mm/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: 14 Sep 2020; epub ahead of print
Cortes C, Chu M, Schincariol M, Martínez-Hervás Alonso MÁ, ... Silber S, Gutiérrez-Chico JL
EuroIntervention: 14 Sep 2020; epub ahead of print | PMID: 32928714
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Impact:
Abstract

Predictors and outcomes of neoatherosclerosis in patients with in-stent restenosis.

Nakamura D, Dohi T, Ishihara T, Kikuchi A, ... Nishino M, Sakata Y
Aims
The purpose of this study was to investigate the impact of neoatherosclerosis on the prognosis after percutaneous coronary intervention (PCI) for in-stent restenosis (ISR).
Methods and results
Between March 2009 and December 2017, 313 ISR lesions in patients undergoing an OCT guided PCI in five hospitals were retrospectively enrolled. Neoatherosclerosis was defined as a lipid neointima or calcified neointima. We examined the association between neoatherosclerosis and the clinical driven (CD-TLR) rates. In 313 ISR lesions, 64 lesions (20.4%) had bare metal stents and 241 lesions (77.0%) had drug eluting stents (DES). Among them, 47.0% of lesions (147 lesions) had neoatherosclerosis. A multivariate logistic regression analysis demonstrated that eGFR (odds ratio (OR), 0.986; 95% confidence interval (CI), 0.974-0.998; P=0.023), the time from the PCI to the ISR (OR, 1.13; 95% CI, 1.06-1.22; P<0.001) and DES-ISR (OR, 2.48; 95% CI, 1.18-5.43; P=0.019 ) were independent predictors with neoatherosclerosis. A multivariate regression analysis demonstrated that neoatherosclerosis was an independent predictor of CD-TLR.
Conclusions
In the multicenter ISR registry, OCT imaging demonstrated that eGFR, the time from the PCI to the ISR and DES-ISR were independent predictors for neoatherosclerosis and neoatherosclerosis in ISR lesions had a worse impact on the CD-TLR.



EuroIntervention: 28 Sep 2020; epub ahead of print
Nakamura D, Dohi T, Ishihara T, Kikuchi A, ... Nishino M, Sakata Y
EuroIntervention: 28 Sep 2020; epub ahead of print | PMID: 32985411
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Impact:
Abstract

Normal Values of Thermodilution-Derived Absolute Coronary Blood Flow and Microvascular Resistance in Humans.

Fournier S, Keulards DCJ, van \'t Veer M, Colaiori I, ... Pijls NHJ, De Bruyne B
Aims
Absolute hyperemic coronary blood flow (Q, in mL/min) and resistance (R, in Woods Units, WU) can be measured invasively by continuous thermodilution. The aim of this study was to assess normal reference values of Q and R.
Methods and results
In 177 arteries (69 patients: 25 controls i.e. without identifiable coronary atherosclerosis; 44 patients with mild, non-obstructive atherosclerosis), thermodilution-derived hyperemic Q and total, epicardial, and microvascular absolute resistances (Rtot, Repi, and Rmicro) were measured. In 20 controls and 29 patients measurements were obtained in all 3 major coronary arteries,thus allowing calculations of Q and R for the whole heart. In 15 controls (41 vessels) and 25 patients (71 vessels),vessel-specific myocardial mass was derived from coronary computed tomography angiography. Whole heart hyperemic Q tended to be higher in controls compared to patients (668±185 vs 582±138 mL/min,p=0.068). In the left anterior descending coronary artery (LAD), hyperemic Q was significantly higher (293±102 mL/min versus 228±71 mL/min,p=0.004) in controls than in patients . This was mainly driven by a difference in Repi (43±23 vs 83±41 WU, p=0.048),without significant differences in Rmicro. After adjustment for vessels-specific myocardial mass, hyperemic Q was similar in the 3 vascular territories (5.9±1.9,4.9±1.7,and 5.3±2.1 mL/min/g,p=0.44,in the LAD, left circumflex and right coronary artery,respectively).
Conclusions
The present report provides reference values of absolute coronary hyperemic Q and R. Q was homogeneously distributed in the 3 major myocardial territories but the large ranges of observed hyperemic values of flow and and of microvascular resistance preclude their clinical use for interpatient comparison.



EuroIntervention: 05 Oct 2020; epub ahead of print
Fournier S, Keulards DCJ, van 't Veer M, Colaiori I, ... Pijls NHJ, De Bruyne B
EuroIntervention: 05 Oct 2020; epub ahead of print | PMID: 33016881
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Impact:
Abstract

Clinical Outcomes with Unselected Use of an Ultrathin-Strut Sirolimus-Eluting Stent: A Report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).

Buccheri S, Sarno G, Erlinge D, Renlund H, ... Böhm F, James SK
Aims
To assess the real-world clinical performance of a sirolimus-eluting ultrathin-strut drug-eluting stent (DES) [Orsiro, Biotronik AG] in a large nationwide cohort of patients undergoing percutaneous coronary intervention (PCI).
Methods and results
From the Swedish Coronary Angiography and Angioplasty Registry, the 2-year outcomes of 4,561 patients implanted with Orsiro (Orsiro group) and 69,570 receiving other newer generation DES (n-DES group) were analyzed. The rate of definite stent thrombosis was low in both groups (0.67% and 0.83% for Orsiro and n-DES, respectively; adjusted hazard ratio [HR] 0.90, 95% confidence interval [CI] 0.55-1.46, p-value 0.66). Restenosis was also infrequent (1.5% versus 2.0% with Orsiro and n-DES, adjusted HR 0.81, 95% CI 0.63-1.03, p-value=0.09). The risk of target lesion revascularization by PCI was lower in the Orsiro group (1.6% versus 2.3%, adjusted HR 0.75, 95% CI 0.60-0.94, p-value=0.013). All-cause mortality and myocardial infarction did not show a statistically significant difference between the two groups (mortality of 7.5% in both groups, adjusted HR 0.99, 95% CI 0.72-1.35, p-value=0.94; 6.0% versus 5.2% for myocardial infarction, adjusted HR 1.19, 95% CI 1.00-1.43, p-value=0.06).
Conclusions
In a nationwide scenario, the use of a sirolimus-eluting ultrathin-strut DES portended favorable clinical outcomes.



EuroIntervention: 05 Oct 2020; epub ahead of print
Buccheri S, Sarno G, Erlinge D, Renlund H, ... Böhm F, James SK
EuroIntervention: 05 Oct 2020; epub ahead of print | PMID: 33016880
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Impact:
Abstract

Two-year Outcomes with the Cardioband Tricuspid System from the Multicentre, Prospective TRI-REPAIR Study.

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



EuroIntervention: 12 Oct 2020; epub ahead of print
Nickenig G, Weber M, Schüler R, Hausleiter J, ... Hahn RT, Maisano F
EuroIntervention: 12 Oct 2020; epub ahead of print | PMID: 33046437
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Impact:
Abstract

Deep Sedation versus General Anaesthesia for Transcatheter Mitral Valve Repair: An Individual-Patient Data Meta-analysis of Observational Studies.

Jobs A, Grund S, de Waha-Thiele S, Ledwoch J, ... Eitel I, Thiele H
Aims
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 was 1.27 (95% confidence interval, 0.78 to 2.09; p = 0.338) and 1.26 (95% confidence interval, 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% confidence interval, 2.18 to 4.36, p < 0.001 and 2.88, 95% confidence interval, 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: 12 Oct 2020; epub ahead of print
Jobs A, Grund S, de Waha-Thiele S, Ledwoch J, ... Eitel I, Thiele H
EuroIntervention: 12 Oct 2020; epub ahead of print | PMID: 33046436
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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 is to evaluate the survival outcome of percutaneous procedures and surgery after unsuccessful TMVR interventions for different etiologies.
Methods and results
Of 824 consecutive patients that 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 vs. 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 wiith PMR showed lower mortality than patients with SMR (p < 0.0001) and reclip patients with PMR (p = 0.073). Atrial fibrillation (HR & 95 CI: 2.915 [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. T he level of post-interventional mitral regurgitation 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 favored over a ReClip 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 Oct 2020; epub ahead of print
Alessandrini H, Dreher A, Harr C, Wohlmuth P, ... Schmoeckel M, Geidel S
EuroIntervention: 19 Oct 2020; epub ahead of print | PMID: 33074154
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Impact:
Abstract

Invasive Assessment of Myocardial Bridging in Patients with Angina and No Obstructive Coronary Artery Disease.

Pargaonkar VS, Kimura T, Kameda R, Tanaka S, ... Schnittger I, Tremmel JA
Aims
Angina and no obstructive CAD (ANOCA) is common. A potential cause of angina in this patient population is a myocardial bridge (MB). We studied the anatomical and hemodynamic characteristics of an MB in patients with angina and no obstructive CAD.
Methods and results
Using intravascular ultrasound (IVUS), we identified 184 MBs in 154 patients. We evaluated MB length, arterial compression, and halo thickness. MB muscle index (MMI) was defined as MB length×halo thickness. Hemodynamic testing of the MB was performed using an intracoronary pressure/Doppler flow wire at rest and during dobutamine stress. We defined an abnormal diastolic fractional flow reserve (dFFR) as ≤0.76 during stress. The median MB length was 22.9 mm, arterial compression 30.9%, and halo thickness 0.5mm. The median MMI was 12.1. Endothelial and microvascular dysfunction were present in 85.4% and 22.1%, respectively. At peak dobutamine stress, 94.2% of patients had a dFFR≤0.76 within and/or distal to the MB. MMI was associated with an abnormal dFFR.
Conclusions
In select patients with ANOCA who have an MB by IVUS, a majority have evidence of a hemodynamically significant dFFR during dobutamine stress, suggesting the MB as a cause of their angina. A comprehensive invasive assessment of such patients during coronary angiography provides important diagnostic information that can guide management.



EuroIntervention: 19 Oct 2020; epub ahead of print
Pargaonkar VS, Kimura T, Kameda R, Tanaka S, ... Schnittger I, Tremmel JA
EuroIntervention: 19 Oct 2020; epub ahead of print | PMID: 33074153
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Impact:
Abstract

Percutaneous Coronary Intervention For Bifurcation Coronary Lesions.The 15th Consensus Document from the European Bifurcation Club.

Burzotta F, Lassen JF, Lefèvre T, Banning AP, ... Louvard Y, Stankovic G

The 15th European Bifurcation Club (EBC) meeting was held in Barcelona in October 2019 and it facilitated a renewed consensus on coronary bifurcation lesions (CBL) and unprotected left main (LM) percutaneous interventions. Bifurcation stenting techniques continue to be refined, developed and tested. It remains evident that provisional approach with optional side-branch treatment utilising T, T and small protrusion (TAP) or culotte continue to provide flexible options for the majority of CBL patients. Debate persists regarding the optimal treatment of side branches, including assessment of clinical significance and thresholds for bail-out treatment. In more complex CBL, especially when involving the LM, adoption of dedicated 2-stent techniques should be considered. Operators using such techniques have to be fully familiar with their procedural steps and should acknowledge associated limitations and challenges. When using 2-stent techniques, failure to perform a final kissing inflation is regarded as a technical failure, since it may jeopardize clinical outcome. The development of novel technical tools and drug regimens deserve attention. In particular, intra-coronary imaging, bifurcation simulation, drug-eluting balloon technology and tailored anti-platelet therapy are identified as promising tools to enhance clinical outcomes. In conclusion, the evolution of a broad spectrum of bifurcation PCI components have resulted from studies extending from bench testing to randomised controlled trials. However, further advances are still needed to achieve the ambitious goal of optimizing the clinical outcomes for every patient undergoing PCI on a CBL.



EuroIntervention: 19 Oct 2020; epub ahead of print
Burzotta F, Lassen JF, Lefèvre T, Banning AP, ... Louvard Y, Stankovic G
EuroIntervention: 19 Oct 2020; epub ahead of print | PMID: 33074152
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Impact:
Abstract

The EURO SHOCK Trial: Design, Aims and Objectives.

Banning AS, Adriaenssens T, Berry C, Bogaerts K, ... Yusuff H, Taylor C
Aims
Cardiogenic shock (CGS) occurs in 6-10% of patients with acute coronary syndromes (ACS). Mortality has fallen over time from 80% to approximately 50% consequent on acute revascularization but plateaued since the 1990s. Once established, patients with CGS develop adverse compensatory mechanisms that contribute to the downwards spiral towards death, which becomes difficult to reverse.
Methods and results
The \"EURO SHOCK\' trial will test the benefit or otherwise of mechanical cardiac support using veno-arterial extra-corporeal membrane oxygenation (VA-ECMO), initiated early after acute percutaneous coronary intervention (PCI) for CGS. The trial sets out to randomize 428 patients with CGS complicating ACS, following primary PCI (P-PCI), to either very early ECMO plus standard pharmacotherapy, or to standard pharmacotherapy alone. It will be conducted in 39 European centers. The primary endpoint is 30-day all-cause mortality with key secondary endpoints: 1) 12-month all-cause mortality or admission for heart failure, 2) 12-month all-cause mortality, 3) 12-month admission for heart failure. Cost-effectiveness analysis (including quality of life measures) will be embedded. Mechanistic and hypothesis-generating sub-studies will be undertaken.
Conclusions
The EURO SHOCK trial will determine whether early initiation of VA-ECMO in patients presenting with ACS-CGS persisting after PCI, improves mortality and morbidity.



EuroIntervention: 26 Oct 2020; epub ahead of print
Banning AS, Adriaenssens T, Berry C, Bogaerts K, ... Yusuff H, Taylor C
EuroIntervention: 26 Oct 2020; epub ahead of print | PMID: 33106225
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Impact:
Abstract

Dual antithrombotic therapy with dabigatran in patients with atrial fibrillation after percutaneous coronary intervention for ST elevation myocardial infarction: results from the randomised RE-DUAL PCI trial.

Zeymer U, Leiva O, Hohnloser SH, Steg PG, ... Bhatt DL, Cannon CP
Aims
To investigate the safety and efficacy of dabigatran dual therapy (110 or 150 mg twice daily, plus clopidogrel or ticagrelor) vs warfarin triple therapy in patients with atrial fibrillation undergoing PCI for ST elevation myocardial infarction (STEMI).
Methods and results
In RE-DUAL PCI, 305 patients with STEMI were randomised to dabigatran 110 mg (n=113 versus 106 warfarin) or 150 mg (n=86 versus 84 warfarin). Primary endpoint was time to first major or clinically relevant non-major bleeding event (MBE/CRNMBE). The thrombotic endpoint was a composite of death, thromboembolic events, or unplanned revascularisation. In STEMI patients, dabigatran 110 mg (HR 0.39, 95% CI 0.20-0.74) and 150 mg (0.43, 0.21-0.89) dual therapy reduced the risk of MBE/CRNMBE versus warfarin triple therapy (p interaction vs all other patients = 0.31 and 0.16). Risk of thrombotic events, for dabigatran 110 mg (HR 1.61, 95% CI: 0.85-3.08) and 150 mg (0.56, 0.20-1.51) had p interactions of 0.20 and 0.33, respectively. For net clinical benefit, HRs were 0.74 (95% CI 0.46-1.17) and 0.49 (0.27-0.91) for dabigatran 110 and 150 mg (p interaction = 0.80 and 0.12).
Conclusions
In patients after PCI for STEMI, dabigatran dual therapy had lower risks of bleeding events versus warfarin triple therapy with similar risks of thromboembolic events, supporting the use of dabigatran dual therapy even in patients with high thrombotic risk.



EuroIntervention: 09 Nov 2020; epub ahead of print
Zeymer U, Leiva O, Hohnloser SH, Steg PG, ... Bhatt DL, Cannon CP
EuroIntervention: 09 Nov 2020; epub ahead of print | PMID: 33164896
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Impact:
Abstract

A randomized comparison of Coronary Stents according to Short or Prolonged durations of Dual Antiplatelet Therapy in patients with Acute Coronary Syndromes: a pre-specified analysis of the SMART-DATE trial.

Jang WJ, Lee JB, Song YB, Choi KH, ... Gwon HC, Hahn JY
Aims
We sought to compare biodegradable-polymer biolimus-eluting stents(BP-BES) with durable-polymer everolimus-eluting(DP-EES) and zotarolimus-eluting stents(DP-ZES) in patients with acute coronary syndrome(ACS) according to different duration of dual antiplatelet therapy(DAPT).
Methods and results
In the SMART-DATE trial, 2712 patients with ACS underwent randomization for allocation of DAPT (6-month [n=1357] or 12-month or longer [n=1355]) and type of stents (BP-BES [n=901]), DP-EES [n=904], or DP-ZES [n=907]). At 18 months, primary endpoint (a composite of cardiac death, myocardial infarction, or stent thrombosis) was 2.6% with BP-BES, 2.0% with DP-EES, and 2.1% with DP-ZES (HR 1.29, 95% CI 0.70-2.39, p =0.42 for BP-BES vs. DP-EES and HR 1.23, 95% CI 0.67-2.26, p =0.50 for BP-BES vs. DP-ZES). The treatment effect of BP-BES for the primary endpoint was consistent among patients receiving 6-month DAPT as well as those receiving 12-month or longer DAPT (BP-BES vs. DP-EES, p interaction =0.48 and BP-BES vs. DP-ZES, p interaction =0.87). After excluding 179 patients (101 in the BP-BES group) who did not receive allocated DES, per-protocol analysis showed similar results.
Conclusions
The risk of a composite of cardiac death, myocardial infarction, or stent thrombosis was not significantly different between patients receiving BP-BES vs. DP-EES or DP-ZES across short or prolonged duration of DAPT after ACS.



EuroIntervention: 02 Nov 2020; epub ahead of print
Jang WJ, Lee JB, Song YB, Choi KH, ... Gwon HC, Hahn JY
EuroIntervention: 02 Nov 2020; epub ahead of print | PMID: 33136005
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Impact:
Abstract

Predictors of Non-Stenting Strategy for Acute Coronary Syndrome Caused by Plaque Erosion: 4-Year Outcomes of the EROSION Study.

He L, Qin Y, Xu Y, Hu S, ... Mintz GS, Yu B
Aims
To test whether a non-stenting anti-thrombotic strategy was still effective at 4-year follow-up in patients enrolled in the EROSION study and to explore potential predictors of long-term prognosis.
Methods and results
Out of 55 patients who completed 1-month follow-up, 52 patients finished 4-year follow-up. The median duration was 4.8 years (4.2 - 5.8 years). The majority of patients remained free from events, and all patients were free from hard endpoints (death, myocardial infarction, stroke, bypass surgery, or heart failure). Only 1 patient had gastrointestinal bleeding, and 11 patients underwent elective target lesion revascularization (TLR). Patients in the non-TLR group had more optical coherence tomography (OCT) thrombus reduction from baseline to 1 month; 95% patients in the non-TLR group versus 45% in the TLR group (p=0.001) met the primary endpoint (thrombus volume reduction >50%). Consistent with the OCT findings, angiographic results showed that the TLR group had less improvement in diameter stenosis (p=0.014) at 1 month compared with non-TLR group.
Conclusions
Four-year follow-up findings reconfirmed the safety of an anti-thrombotic therapy without stenting for erosion-caused acute coronary syndrome. Patients with better response to anti-thrombotic therapy in the first month were less likely to require stent implantation during the next four years.



EuroIntervention: 09 Nov 2020; epub ahead of print
He L, Qin Y, Xu Y, Hu S, ... Mintz GS, Yu B
EuroIntervention: 09 Nov 2020; epub ahead of print | PMID: 33164894
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Impact:
Abstract

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

Rodriguez-Leor O, Cid Alvarez AB, de Prado AP, Rossello X, ... Romaguera R, Moreno R
Aims
To assess clinical and prognosis differences in patients with Covid-19 and STEMI.
Methods and results
Using a nationwide registry of consecutive patients managed within 42 specific STEMI-care networks, we compared patient and procedure characteristics and in-hospital outcomes in 2 different cohorts, according to whether they had Covid-19. Among 1010 consecutive STEMI patients, 91 were identified as Covid-19 (10.9%). With the exception of smoking status (more frequent in non-Covid-19) and previous coronary artery disease (more frequent in Covid-19), clinical characteristics were similar between groups, but Covid-19 patients had more heart failure on arrival (31.9% vs 18.4%, p=0.002). Mechanical thrombectomy (44% vs 33.5%, p=0.046) and IIbIIIa inhibitors administration (20.9% vs 11.2%, p=0.007) were more frequent in Covid-19 patients, who had an increased in-hospital mortality (23.1% vs 5.7%, p<0.0001), that remained consistent after adjustment for age, sex, Killip class and ischemic time: OR (95% CI) = 4.85 (2.04-11.51); p<0.001. Covid-19 patients had an increase of stent thrombosis (3.3% vs 0.8%, p=0.020) and cardiogenic shock development after PCI (9.9 % vs 3.8%, p=0.007).
Conclusions
Our study revealed a significant increase in in-hospital, stent thrombosis and cardiogenic shock development after PCI in patients with STEMI and Covid-19 in comparison with contemporaneous non-Covid-19 STEMI patients.



EuroIntervention: 09 Nov 2020; epub ahead of print
Rodriguez-Leor O, Cid Alvarez AB, de Prado AP, Rossello X, ... Romaguera R, Moreno R
EuroIntervention: 09 Nov 2020; epub ahead of print | PMID: 33164893
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Impact:
Abstract

One-step anatomic and function testing by cardiac CT versus second-line functional testing in symptomatic patients with coronary artery stenosis: head-to-head comparison of CT-derived fractional flow reserve and myocardial perfusion imaging.

Westra J, Li Z, Rasmussen LD, Winther S, ... Bøttcher M, Tu S
Aims
CT-QFR is a novel coronary computed tomography angiography (CTA) based method for on-site evaluation of patients with suspected obstructive coronary artery disease (CAD). We compared the diagnostic performance of CT-QFR with myocardial perfusion scintigraphy (MPS) and cardiovascular magnetic resonance (CMR) as second-line tests in patients with suspected obstructive CAD after coronary CTA.
Methods and results
Paired analysis of CT-QFR and MPS or CMR, with an invasive FFR-based classification as reference standard. Symptomatic patients with >50% diameter stenosis on coronary CTA were randomized to MPS or CMR and referred for invasive coronary angiography. The rate of coronary CTA not feasible for CT-QFR analysis was 17%. Paired patient-level data were available for 118 patients in the MPS group and 113 in the CMR group, respectively. Patient-level diagnostic accuracy was better for CT-QFR than for both MPS ((82.2% (95%CI 75.2-89.2) vs. 70.3% (95%CI 62.0-78.7), p=0.029) and CMR ((77.0% (95%CI 69.1-84.9) vs. 65.5% (95%CI 56.6-74.4), p=0.047). Following a positive coronary CTA and with the intention-to diagnose, CT-QFR, CMR and MPS were equally suitable as rule-in and rule-out modalities.
Conclusions
The diagnostic performance of CT-QFR as second-line test was at least similar to MPS and CMR for the evaluation of obstructive coronary artery disease in symptomatic patients presenting with ≥50% diameter stenosis on coronary CTA.



EuroIntervention: 16 Nov 2020; epub ahead of print
Westra J, Li Z, Rasmussen LD, Winther S, ... Bøttcher M, Tu S
EuroIntervention: 16 Nov 2020; epub ahead of print | PMID: 33196446
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Impact:
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
Aims
IVUS is currently recommended by international guidelines to guide left main stem (LMS) PCI. Although OCT resolution outmatches IVUS, this tool is not yet recommended in LMS angioplasty due to the absence of data. This pilot study aimed to analyze the feasibility, safety and impact of OCT-guided LMS PCI.
Methods and results
This prospective, multicenter 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). Seventy patients were included in the final analysis (median age: 72 (64-81) y, 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 struts malapposition in 24% of the cases. OCT guidance modified operators\' strategy in 26% of the patients. The one-year survival free from major clinical adverse events was 98.6 (97.2-100) %.
Conclusions
This study is the first to report the feasibility and performance of OCT-guided LMS PCI according to a pre-specified protocol.



EuroIntervention: 23 Nov 2020; epub ahead of print
Amabile N, Rangé G, Souteyrand G, Godin M, ... Motreff P, Caussin C
EuroIntervention: 23 Nov 2020; epub ahead of print | PMID: 33226003
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Impact:
Abstract

Prioritized 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. We propose a novel prioritized endpoint framework for determining the treatment benefit of renal denervation (RDN) compared with sham control.
Methods and results
We analysed the SPYRAL HTN-ON MED pilot study data using a prioritized hierarchical endpoint comprised of 24-hour mean ambulatory systolic blood pressure (SBP), office SBP, and medication burden. A generalized pairwise comparisons methodology (win ratio) is 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 define treatment \'winners\' and \'losers\'. For a total 1596 unmatched pairs, the RDN subject was the winner in 1050 pairs; 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, 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 prioritizing those endpoints considered most clinically important. Applying these methods to the SPYRAL HTN-ON MED pilot study, RDN was determined superior regarding a hierarchical endpoint and a \'winner\' compared with sham control patients. Classifications Renal sympathetic denervation, uncontrolled hypertension, clinical trials.



EuroIntervention: 23 Nov 2020; epub ahead of print
Kandzari DE, Hickey GL, Pocock SJ, Weber MA, ... Lamberti G, Mahfoud F
EuroIntervention: 23 Nov 2020; epub ahead of print | PMID: 33226002
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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
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 3 months and in 72% beyond 3 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 optimization 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 3 months, is mostly subclinical and resolves after optimization of antithrombotic treatment. An anticoagulation therapy for at least 3 months after the procedure is mandatory.



EuroIntervention: 23 Nov 2020; epub ahead of print
Kikoïne J, Urena M, Chong Nguyen C, Fischer Q, ... Iung B, Himbert D
EuroIntervention: 23 Nov 2020; epub ahead of print | PMID: 33226001
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Impact:
Abstract

Revascularisation or medical therapy in elderly patients with acute anginal syndromes (RINCAL) A Randomised Trial.

de Belder A, Myat A, Blaxill J, Haworth P, ... Robinson DR, Hildick-Smith D
Aims
To determine whether an intervention-guided strategy is superior to optimal medical therapy (OMT) for treating non-ST-elevation myocardial infarction (NSTEMI) in the elderly.
Methods and results
Patients (≥80 years, chest pain, ischaemic ECG, and elevated troponin) were randomised 1:1 to an invasive strategy plus OMT versus OMT alone. The combined primary endpoint was all-cause mortality and non-fatal myocardial re-infarction at 1 year. We enrolled 251 patients (n=125 invasive vs. n=126 conservative) from May 2014 to September 2018. Almost half 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 combined endpoint (invasive 18.5% [23/124] vs. conservative 22.2% [28/126]; p=0.39) or in all-cause mortality alone (invasive 10.5% [13/124] vs. conservative 11.1% [14/126]; p=0.88). There was less angina at 3 months (p<0.001) in the intervention arm. 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) were non-significantly more frequent after OMT alone.
Conclusions
The trial was underpowered to provide a definitive conclusion regarding the primary endpoint. An intervention-guided strategy did, however, result in less angina, reinfarction and unplanned revascularisation but did not improve survival.



EuroIntervention: 23 Nov 2020; epub ahead of print
de Belder A, Myat A, Blaxill J, Haworth P, ... Robinson DR, Hildick-Smith D
EuroIntervention: 23 Nov 2020; epub ahead of print | PMID: 33226000
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Abstract

Super High-Pressure Balloon versus Scoring Balloon to Prepare Severely Calcified Coronary Lesions: The ISAR-CALC Randomized Trial.

Rheude T, Rai H, Richardt G, Allali A, ... Byrne RA, Cassese S
Aims
The comparative efficacy of balloon-based techniques to prepare severely calcified coronary lesions before stenting remains poorly studied. We sought to compare stent expansion following preparation of severely calcified coronary lesions with either super high-pressure balloon or scoring balloon.
Methods and results
In this randomized, open-label trial 74 patients with severely calcified coronary lesions were enrolled at 5 centers in Germany and Switzerland. After unsuccessful lesion preparation with standard non-compliant balloon (<30% reduction of baseline diameter stenosis), participants were randomized to pre-dilation with either super high-pressure balloon or scoring balloon before drug-eluting stent (DES) implantation. The primary endpoint of the study was stent expansion index as assessed by optical coherence tomography (OCT). The key secondary endpoints included angiographic, strategy and procedural success. OCT data after DES implantation was available for 70 patients (94.6%). Lesion preparation with super high-pressure balloon versus scoring balloon led to comparable stent expansion index (0.72±0.12 versus 0.68±0.13; p=0.22). Compared with scoring balloon, super high-pressure balloon increased minimum lumen diameter (2.83±0.34 mm versus 2.65±0.36 mm; p=0.03) and reduced diameter stenosis (11.6±4.8% versus 14.4±5.6%; p=0.02) without difference in terms of angiographic success (100% versus 97.3%; p>0.99). Strategy success (91.9% versus 83.8%; p=0.48) and procedural success (100% versus 89.2%; p=0.12) were numerically more frequent with super high-pressure balloon versus scoring balloon.
Conclusions
In patients with severely calcified coronary artery lesions, preparation with super high-pressure balloon versus scoring balloon was associated with comparable stent expansion on intravascular imaging and a signal toward improved angiographic performance.



EuroIntervention: 30 Nov 2020; epub ahead of print
Rheude T, Rai H, Richardt G, Allali A, ... Byrne RA, Cassese S
EuroIntervention: 30 Nov 2020; epub ahead of print | PMID: 33258774
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This program is still in alpha version.