Journal: EuroIntervention

Sorted by: date / impact
Abstract

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

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



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

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

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



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

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

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



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

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

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



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

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

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



EuroIntervention: 18 Feb 2021; 16:1154-1162
Nakamura M, Kadota K, Nakao K, Nakagawa Y, ... Kuroda T, Murakami Y
EuroIntervention: 18 Feb 2021; 16:1154-1162 | PMID: 32624464
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

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

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



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

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

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



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

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

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



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

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

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



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

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

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



EuroIntervention: 15 Feb 2021; epub ahead of print
Lerakis S, Kini AS, Asch FM, Kar S, ... Mack MJ, Stone GW
EuroIntervention: 15 Feb 2021; epub ahead of print | PMID: 33589408
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

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

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



EuroIntervention: 04 Feb 2021; 16:e1245-e1253
Spirito A, Gargiulo G, Siontis GCM, Mitsis A, ... Windecker S, Valgimigli M
EuroIntervention: 04 Feb 2021; 16:e1245-e1253 | PMID: 32624462
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

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

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



EuroIntervention: 04 Feb 2021; 16:e1264-e1271
Nickenig G, Weber M, Schüler R, Hausleiter J, ... Hahn RT, Maisano F
EuroIntervention: 04 Feb 2021; 16:e1264-e1271 | PMID: 33046437
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

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

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



EuroIntervention: 04 Feb 2021; 16:e1288-e1294
Freixa X, Cepas-Guillen P, Flores-Umanzor E, Regueiro A, ... Sitges M, Sabaté M
EuroIntervention: 04 Feb 2021; 16:e1288-e1294 | PMID: 33164895
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Automatic Characterisation of Human Atherosclerotic Plaque Composition from Intravascular Optical Coherence Tomography Using Artificial Intelligence.

Chu M, Jia H, Gutiérrez-Chico JL, Maehara A, ... Holm NR, Tu S
Background
Intravascular optical coherence tomography (IVOCT) enables detailed plaque characterisation in-vivo, but visual assessment is time-consuming and subjective.
Aims
This study aims to develop and validate an automatic framework for IVOCT plaque characterisation using artificial intelligence (AI).
Methods
IVOCT pullbacks from 5 international centres were analysed in a corelab, annotating basic plaque components, inflammatory markers and other structures. A deep convolutional network with encoding-decoding architecture and pseudo-3D input was developed and trained using hybrid loss. The proposed network was integrated into commercial software to be externally validated on additional IVOCT pullbacks from three international corelabs, taking the consensus among corelabs as reference.
Results
Annotated images from 509 pullbacks (391 patients) were divided into 10,517 and 1,156 cross-sections for the training and testing datasets, respectively. Dice coefficient of the model was 0.906 for fibrous plaque, 0.848 for calcium and 0.772 for lipid in the testing dataset. Excellent agreement in plaque burden quantification was observed between the model and manual measurements (R2=0.98). In the external validation, the software correctly identified 518 out of 598 plaque regions from 300 IVOCT cross-sections, with a diagnostic accuracy of 97.6%[95%CI:93.4%-99.3%] in fibrous plaque, 90.5%[95%CI:85.2%-94.1%] in lipid and 88.5%[95%CI:82.4%-92.7%] in calcium. The median time required for analysis was 21.4 (18.6-25.0) seconds per pullback.
Conclusions
A novel AI framework for automatic plaque characterisation in IVOCT was developed, providing excellent diagnostic accuracy in both internal and external validation. This model might reduce subjectivity in image interpretation and facilitate IVOCT quantification of plaque composition, with potential applications in research and IVOCT-guided PCI.



EuroIntervention: 01 Feb 2021; epub ahead of print
Chu M, Jia H, Gutiérrez-Chico JL, Maehara A, ... Holm NR, Tu S
EuroIntervention: 01 Feb 2021; epub ahead of print | PMID: 33528359
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Thermodilution-Derived Volumetric Resting Coronary Blood Flow Measurement in Humans.

Gallinoro E, Candreva A, Colaiori I, Kodeboina M, ... Collet C, De Bruyne B
Background
Quantification of microvascular function requires the measurement of flow and resistance at rest and during hyperemia. Continuous intracoronary thermodilution accurately measures coronary flow during hyperemia.
Aims
To study whether continuous coronary thermodilution using lower infusion rates also enables volumetric coronary blood flow measurements (in mL/min) at rest.
Methods
In 59 patients (88 arteries), the ratio of distal to proximal coronary pressure (Pd/Pa), as well as absolute blood flow (in mL/min) by continuous thermodilution, were recorded using a pressure/temperature guide wire. Saline was infused at rates of 10 and 20 mL/min. In 27 arteries, Doppler average peak velocity (APV) was measured simultaneously. Pd/Pa, APV, thermodilution-derived coronary flow reserve (CFRthermo) and coronary flow velocity reserve (CFVR) were assessed. In 10 arteries, simultaneous recordings were obtained at saline infusion rates of 6, 8, 10 and 20 mL/min.
Results
Compared to baseline, saline infusion at 10 mL/min did not change Pd/Pa (0.95±0.05 versus 0.94±0.05, p=0.49) nor APV (22±8 versus 23±8 cm/s, p=0.60); conversely, an infusion rate of 20 mL/min induced a decrease in Pd/Pa and an increase in APV. Stable thermodilution tracings were obtained during saline infusion at 8 and 10 mL/min, but not at 6 mL/min. Mean values of CFRthermo and CFVR were similar (2.78±0.91 versus 2.76±1.06, p=0.935) and their individual values correlated closely (r=0.89, 95%CI 0.78 - 0.95, p&lt;0.001).
Conclusions
In addition to hyperemic flow, continuous thermodilution can quantify absolute resting coronary blood flow; therefore it can be used to calculate coronary flow reserve and microvascular resistance reserve.



EuroIntervention: 01 Feb 2021; epub ahead of print
Gallinoro E, Candreva A, Colaiori I, Kodeboina M, ... Collet C, De Bruyne B
EuroIntervention: 01 Feb 2021; epub ahead of print | PMID: 33528358
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

European position paper on the management of patients with patent foramen ovale. Part II - Decompression sickness, migraine, arterial deoxygenation syndromes and select high-risk clinical conditions.

Pristipino C, Germonpré P, Toni D, Sievert H, ... European Haematological Society (EHA), European Underwater and Baromedical Society (EUBS)
Patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions but to date only one official position paper related to left circulation thromboembolism has been published. This interdisciplinary paper, prepared with the involvement of eight European scientific societies, reviews the available evidence and proposes a rationale for decision making for other PFO-related clinical conditions. In order to guarantee a strict evidence-based process, we used a modified grading of recommendations, assessment, development, and evaluation (GRADE) methodology. A critical qualitative and quantitative evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk/benefit ratio. The level of evidence and the strength of the position statements were weighed and graded according to predefined scales. Despite being based on limited and observational or low-certainty randomised data, a number of position statements were made to frame PFO management in different clinical settings, along with suggestions for new research avenues. This interdisciplinary position paper, recognising the low or very low certainty of existing evidence, provides the first approach to several PFO-related clinical scenarios beyond left circulation thromboembolism and strongly stresses the need for fresh high-quality evidence on these topics.



EuroIntervention: 27 Jan 2021; epub ahead of print
Pristipino C, Germonpré P, Toni D, Sievert H, ... European Haematological Society (EHA), European Underwater and Baromedical Society (EUBS)
EuroIntervention: 27 Jan 2021; epub ahead of print | PMID: 33506796
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Incidence and Clinical Impact of Major Bleeding Following Left Atrial Appendage Occlusion: Insights from the Amplatzer™ Amulet™ LAA Occluder Observational Study.

Aminian A, De Backer O, Nielsen-Kudsk JE, Mazzone P, ... Diener HC, Schmidt B
Background
Major bleeding (MB) events are independent predictors of mortality after cardiac interventional procedures. The clinical relevance of MB following left atrial appendage occlusion (LAAO) remains unclear.
Aims
This study aimed to investigate the incidence and clinical impact of MB after LAAO in a real-world population at high-risk for bleeding and contraindicated to anticoagulation.
Methods
The 2-year results of the Amplatzer™ Amulet™ Occluder Observational Study were analyzed. An independent committee adjudicated MBs according to the Bleeding Academic Research Consortium scale. Cox proportional hazards regression identified variables associated with MB events and mortality.
Results
The MB rate was 7.2%/year, with a rate of 10.1%/year during year one, decreasing to 4.0%/year over year two. The most common bleeding location was gastrointestinal, accounting for 48% of MBs. Pre-LAAO MB was associated with an increased risk for post-LAAO MB (HR 2.34; 95% CI 1.37-3.99). The occurrence of post-LAAO MB was associated with increased mortality (37.3% vs 12.7%; p&lt;0.0001), mainly driven by events occurring beyond the peri-procedural period. The annualized rate of ischemic stroke or TIA was similar in patients with and without MB (2.3% vs 3.3%; p=0.446). MB post-LAAO was a strong independent predictor of mortality (HR 3.07; 95% CI 2.15-4.40).
Conclusions
In real-world patients at high bleeding risk, MB following LAAO was not uncommon and associated with a significant increase in mortality, without increasing the risk of stroke.



EuroIntervention: 25 Jan 2021; epub ahead of print
Aminian A, De Backer O, Nielsen-Kudsk JE, Mazzone P, ... Diener HC, Schmidt B
EuroIntervention: 25 Jan 2021; epub ahead of print | PMID: 33495144
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Plaque characteristics in patients with ST-segment elevation myocardial infarction and early spontaneous reperfusion.

Guo J, Chen J, Wang G, Liu Z, ... Liu B, Li J
Background
Early spontaneous reperfusion (ESR) is not an uncommon phenomenon in clinical settings.
Aims
To detect potential mechanisms of early spontaneous reperfusion in patients with STEMI.
Methods
This prospective study enrolled a total of 241 consecutive patients with STEMI undergoing optical coherence tomography (OCT) from July 2016 to August 2019. Forty-five (18.7%) met angiographic ESR criteria (TIMI-3 flow on the initial angiogram). Among those without ESR (TIMI-0 flow on initial angiogram), 45 patients were assigned into the control group according to propensity score matching with the ESR group.
Results
Although the group\'s baseline characteristics were comparable, non-ruptured plaque (62.2% vs 35.6%) predominated and plaque rupture (37.8% vs 64.4%) was less common in the ESR group (P=0.011). Red thrombus (44.4% vs. 77.8%) was also less common in the ESR group (P=0.001). Lastly, compared to the control group, the ESR group underwent fewer emergent stents placements (68.9% vs. 91.1%, P=0.008).
Conclusions
Relief of coronary occlusion induced by a non-ruptured plaque may contribute to early spontaneous reperfusion in patients with STEMI.



EuroIntervention: 25 Jan 2021; epub ahead of print
Guo J, Chen J, Wang G, Liu Z, ... Liu B, Li J
EuroIntervention: 25 Jan 2021; epub ahead of print | PMID: 33495143
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Repeat transcatheter aortic valve replacement and implications for transcatheter heart valve performance: insights from bench testing.

Sathananthan J, Fraser R, Landes U, Rich C, ... Søndergaard L, Webb JG
Background
THV implantation within failed surgical valves is well established. However the implications of THV implantation within failed THVs is poorly understood.
Aims
This study assessed the impact of different transcatheter heart valve (THV) designs and implant positioning strategies on hydrodynamic performance after redo transcatheter aortic valve implantation (TAVI).
Methods
THVs of varying design (Sapien 3, Evolut Pro, Acurate neo, Allegra, and Portico) and sizes were implanted inside Sapien XT and Evolut R THVs. Hydrodynamic function as per International Standard Organization (ISO) specifications was evaluated using a pulse duplicator and multimodality imaging was performed.
Results
The majority of tested THV-in-THV combinations resulted in stable anchoring of the new implant. However some combinations resulted in unstable anchoring with the potential for dislodgement or embolization. Hydrodynamic function was favourable for all tested THV designs implanted in the intra-annular Sapien XT THV. Sapien 3 implantation within an Evolut THV with supra-annular leaflets must be appropriately sized to ensure adequate anchoring. Avoidance of an intra-annular deployment mitigated leaflet overhang of the Evolut leaflets and optimized hydrodynamic performance.
Conclusions
This study demonstrates that most THV designs and implantation strategies can result in favourable hydrodynamic performance following redo-TAVI. Whether the leaflets of a failed THV are intra- or supra-annular may have important implications for the positioning of a redo-THV implant. Certain THV designs or implantation positions may be more desirable when performing redo-TAVI.



EuroIntervention: 25 Jan 2021; epub ahead of print
Sathananthan J, Fraser R, Landes U, Rich C, ... Søndergaard L, Webb JG
EuroIntervention: 25 Jan 2021; epub ahead of print | PMID: 33495142
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Outcomes of optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation: one-year results from the ILUMIEN III: OPTIMIZE PCI trial.

Ali ZA, Karimi Galougahi K, Maehara A, Shlofmitz RA, ... West NEJ, Stone GW
Aims
In the ILUMIEN III trial, among 450 randomised patients with non-complex lesions undergoing percutaneous coronary intervention (PCI), optical coherence tomography (OCT) guidance led to greater stent expansion than angiography guidance, similar minimal stent area compared to both intravascular ultrasound (IVUS) guidance and angiography guidance, and lower rates of uncorrected dissection and malapposition than both IVUS guidance and angiography guidance. Whether these differences impact on clinical outcomes is unknown. The aim of the present study was to report the 12-month clinical follow-up data from the ILUMIEN III study.
Methods and results
OCT-guided PCI, using an external elastic lamina-based protocol, was compared to operator-directed IVUS-guided or angiography-guided PCI. Target lesion failure (TLF) and major adverse cardiovascular events (MACE) at 12 months were adjudicated by a blinded clinical events committee. There were no significant differences in the rates of TLF (2.0% OCT, 3.7% IVUS, 1.4% angiography), MACE (9.8% OCT, 9.1% IVUS, 7.9% angiography), or any of the individual components of these outcomes among the groups. No independent predictors of 12-month stent-related clinical events were identified from final OCT.
Conclusions
In this underpowered study, OCT-guided PCI of non-complex lesions did not show a statistical difference in clinical outcomes at 12 months compared with IVUS or angiography guidance. An appropriately powered trial, including only complex patients and lesions, is underway to substantiate the potential clinical benefit of OCT-guided PCI.
Trial registration
NCT02471586.



EuroIntervention: 19 Jan 2021; 16:1085-1091
Ali ZA, Karimi Galougahi K, Maehara A, Shlofmitz RA, ... West NEJ, Stone GW
EuroIntervention: 19 Jan 2021; 16:1085-1091 | PMID: 32540793
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

An EAPCI Expert Consensus Document on Ischaemia with Non-Obstructive Coronary Arteries in Collaboration with European Society of Cardiology Working Group on Coronary Pathophysiology & Microcirculation Endorsed by Coronary Vasomotor Disorders International Study Group.

Kunadian V, Chieffo A, Camici PG, Berry C, ... Capodanno D, Baumbach A
This consensus document, a summary of the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI), appraises the importance of ischaemia with non-obstructive coronary arteries (INOCA). Angina pectoris affects approximately 112 million people globally. Up to 70% of patients undergoing invasive angiography do not have obstructive coronary artery disease, more common in women than in men, and a large proportion have INOCA as a cause of their symptoms. INOCA patients present with a wide spectrum of symptoms and signs that are often misdiagnosed as non-cardiac leading to under-diagnosis/investigation and under-treatment. INOCA can result from heterogeneous mechanism including coronary vasospasm and microvascular dysfunction and is not a benign condition. Compared to asymptomatic individuals, INOCA is associated with increased incidence of cardiovascular events, repeated hospital admissions, as well as impaired quality of life and associated increased health care costs. This consensus document provides a definition of INOCA and guidance to the community on the diagnostic approach and management of INOCA based on existing evidence from research and best available clinical practice; noting gaps in knowledge and potential areas for further investigation.



EuroIntervention: 19 Jan 2021; 16:1049-1069
Kunadian V, Chieffo A, Camici PG, Berry C, ... Capodanno D, Baumbach A
EuroIntervention: 19 Jan 2021; 16:1049-1069 | PMID: 32624456
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Transcatheter reshaping of the mitral annulus in patients with functional mitral regurgitation: one-year outcomes of the MAVERIC trial.

Worthley S, Redwood S, Hildick-Smith D, Rafter T, ... Gregson J, Erglis A
Aims
The aim of this study was to assess the one-year safety and efficacy of the transcatheter ARTO system in the treatment of functional mitral regurgitation (FMR).
Methods and results
MAVERIC is a multicentre, prospective, non-randomised pre-commercial study. Eligible patients were on guideline-recommended therapy for NYHA Class II-IV systolic heart failure and had an FMR grade ≥2+. The ARTO system was implanted in forty-five (100%) patients. The primary safety composite endpoint (death, stroke, myocardial infarction, device-related surgery, cardiac tamponade, renal failure) at 30 days and one year was 4.4% (95% CI: 1.5-16.6) and 17.8% (95% CI: 9.3-32.4), respectively. Periprocedural complications occurred in seven patients (15.5% [95% CI: 6.5-29.5]), and five patients (11.1% [95% CI: 4.9-24.0]) died during one-year follow-up. Paired results for 36 patients demonstrated that 24 (66.7%) had grade 3+/4+ mitral regurgitation at baseline; however, only five (13.9%) and three (8.3%) patients remained at grade 3+/4+ 30 days and one year post procedure (p<0.0001). Echocardiographic parameters such as anteroposterior annulus diameter decreased from 41.4 mm (baseline) to 36.0 and 35.3 mm at 30 days and one year, respectively (p<0.0001). Twenty-five patients (69.4%) had baseline NYHA Class III/IV symptoms decreasing significantly to nine (25.0%) at 30 days and eight (22.2%) at one year post procedure (p<0.0001).
Conclusions
The ARTO transcatheter mitral valve repair system is both safe and effective in decreasing FMR up to one year post procedure.



EuroIntervention: 19 Jan 2021; 16:1106-1113
Worthley S, Redwood S, Hildick-Smith D, Rafter T, ... Gregson J, Erglis A
EuroIntervention: 19 Jan 2021; 16:1106-1113 | PMID: 32718911
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Optical coherence tomography-guided coronary stent implantation compared to angiography: a multicentre randomised trial in PCI - design and rationale of ILUMIEN IV: OPTIMAL PCI.

Ali Z, Landmesser U, Karimi Galougahi K, Maehara A, ... West NEJ, Stone GW
Aims
Randomised trials have demonstrated improvement in clinical outcomes with intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) compared with angiography-guided PCI. The ILUMIEN III trial demonstrated non-inferiority of an optical coherence tomography (OCT)- versus IVUS-guided PCI strategy in achieving similar post-PCI lumen dimensions. ILUMIEN IV is a large-scale, multicentre, randomised trial designed to demonstrate the superiority of OCT- versus angiography-guided stent implantation in patients with high-risk clinical characteristics (diabetes) and/or complex angiographic lesions in achieving larger post-PCI lumen dimensions and improving clinical outcomes.
Methods and results
ILUMIEN IV is a prospective, single-blind clinical investigation that will randomise between 2,490 and 3,656 patients using an adaptive design to OCT-guided versus angiography-guided coronary stent implantation in a 1:1 ratio. The primary endpoints are: (1) post-PCI minimal stent area assessed by OCT in each randomised arm, and (2) target vessel failure, the composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target vessel revascularisation. Clinical follow-up will continue for up to two years. The trial is currently enrolling, and the principal results are expected in 2022.
Conclusions
The large-scale ILUMIEN IV randomised controlled trial will evaluate the effectiveness of OCT-guided versus angiography-guided PCI in improving post-PCI lumen dimensions and clinical outcomes in patients with diabetes and/or with complex coronary lesions.
Trial registration
NCT03507777.



EuroIntervention: 19 Jan 2021; 16:1092-1099
Ali Z, Landmesser U, Karimi Galougahi K, Maehara A, ... West NEJ, Stone GW
EuroIntervention: 19 Jan 2021; 16:1092-1099 | PMID: 32863246
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Spontaneous echo contrast, left atrial appendage thrombus and stroke in patients undergoing transcatheter aortic valve implantation.

Linder M, Voigtländer L, Schneeberger Y, Bhadra OD, ... Conradi L, Seiffert M
Aims
The relevance of spontaneous echo contrast (SEC) and left atrial appendage thrombus (LAAT) in patients undergoing transcatheter aortic valve implantation (TAVI) remains unclear. In this study, we aimed to assess the prevalence of SEC and LAAT and evaluate the impact on periprocedural outcome after TAVI.
Methods and results
A total of 2,549 consecutive patients underwent TAVI between 2008 and 2017. After exclusion of cases with insufficient imaging, concomitant procedures or severe intraprocedural complications, 1,558 cases were analysed. Three groups were defined according to (pre)thrombotic formations - moderate or severe SEC (n=89), LAAT (n=53), and reference (n=1,416). The primary outcome was disabling ischaemic stroke within 24 hours. The prevalence was 4.4% for LAAT and 5.4% for moderate/severe SEC. The primary outcome occurred more frequently in patients with moderate/severe SEC (6.8%) compared to the reference (2.1%) and LAAT (1.9%) groups (p=0.020). SEC was identified as an independent risk factor for the primary outcome (OR 3.54 [95% CI: 1.30-9.61], p=0.013). LAAT was associated with an impaired unadjusted one-year survival (43.4%) compared to the SEC (27.3%) and reference groups (18.7%, p<0.001).
Conclusions
SEC and LAAT were detected in a relevant number of patients undergoing TAVI. SEC may represent an important risk factor for intraprocedural stroke; increased mortality was observed in patients with LAAT. Visual summary. Left atrial appendage thrombus or (pre)thrombotic formations were observed in a relevant number of patients undergoing TAVI. An increased risk for periprocedural cerebrovascular events was observed if moderate or severe spontaneous echo contrast was present. The unadjusted all-cause mortality was higher in patients with left atrial appendage thrombus.



EuroIntervention: 19 Jan 2021; 16:1114-1122
Linder M, Voigtländer L, Schneeberger Y, Bhadra OD, ... Conradi L, Seiffert M
EuroIntervention: 19 Jan 2021; 16:1114-1122 | PMID: 32863242
Go to: DOI | PubMed | PDF | Google Scholar |
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 coronary artery disease (ANOCA) is common. A potential cause of angina in this patient population is a myocardial bridge (MB). We aimed to study the anatomical and haemodynamic characteristics of an MB in patients with ANOCA.
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. Haemodynamic 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 0.5 mm. 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, the majority have evidence of a haemodynamically significant dFFR during dobutamine stress, suggesting the MB as being 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 Jan 2021; 16:1070-1078
Pargaonkar VS, Kimura T, Kameda R, Tanaka S, ... Schnittger I, Tremmel JA
EuroIntervention: 19 Jan 2021; 16:1070-1078 | PMID: 33074153
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Ticagrelor versus clopidogrel in patients with STEMI treated with thrombolysis: the MIRTOS trial.

Hamilos M, Kanakakis J, Anastasiou I, Karvounis C, ... Vardas P, Collaborators
Aims
We aimed to demonstrate whether coronary microvascular function is improved after ticagrelor administration compared to clopidogrel administration in STEMI subjects undergoing thrombolysis.
Methods and results
MIRTOS is a multicentre study of ticagrelor versus clopidogrel in STEMI subjects treated with fibrinolysis. We enrolled 335 patients <75 years old with STEMI eligible for thrombolysis, of whom 167 were randomised to receive clopidogrel and 168 to receive ticagrelor together with thrombolysis. Primary outcome was the difference in post-PCI corrected TIMI frame count (CTFC). All clinical events were recorded in a three-month follow-up period. From the 335 patients who were randomised, 259 underwent PCI (129 clopidogrel and 130 ticagrelor) and 154 angiographies were analysable for the study primary endpoint. No significant difference was found between the clopidogrel (n=85) and ticagrelor (n=69) groups for CTFC (24.33±17.35 vs 28.33±17.59, p=0.10). No significant differences were observed in MACE and major bleeding events between randomisation groups (OR 2.0, 95% CI: 0.18-22.2, p=0.99).
Conclusions
Thrombolysis with ticagrelor in patients <75 years old was not able to demonstrate superiority compared to clopidogrel in terms of microvascular injury, while there was no difference between the two groups in MACE and major bleeding events.
Trial registration
ClinicalTrials.gov Identifier: NCT02429271. EudraCT Number 2014-004082-25.



EuroIntervention: 18 Jan 2021; 16:1163-1169
Hamilos M, Kanakakis J, Anastasiou I, Karvounis C, ... Vardas P, Collaborators
EuroIntervention: 18 Jan 2021; 16:1163-1169 | PMID: 32715996
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Clinical outcomes of post-stent intravascular ultrasound examination for chronic total occlusion intervention with drug-eluting stents.

Kwon O, Lee PH, Lee SW, Brilakis ES, ... Lee CW, Park SW
Background
Few studies have evaluated intravascular ultrasound (IVUS) use in chronic total occlusion (CTO) percutaneous coronary intervention (PCI).
Aims
In CTO-PCI, we aimed to (1) evaluate the clinical benefits of performing post-stent IVUS in preventing adverse clinical events, and (2) identify IVUS parameters and cut-off values for prediction of target-lesion revascularization (TLR)/reocclusion.
Methods
A total of 1,077 patients with 1077 CTO lesions treated with drug-eluting stents (DES) were included. Clinical outcomes during a median follow-up of 6.3 years were compared between subjects with or without post-stent IVUS using the inverse probability weighting method.
Results
Of 1,077 patients, post-stent IVUS was performed in 838 (77.8%) cases while the remaining 239 (22.2%) cases did not undergo. In the weighted population, the risk of TLR/reocclusion was significantly lower in subjects with post-stent IVUS (9.6% vs. 18.9%, hazard ratio [HR], 0.54; 95% confidence interval [CI], 0.34-0.86, P=0.01), compared with those without post-stent IVUS. Cox-regression analysis showed that minimal stent area (MSA) measured by IVUS was the only parameter independently associated with TLR/reocculsion (HR, 0.78; 95% CI 0.64-0.95; P=0.01) and the optimal MSA cut-off value was 4.9 mm2 for prediction of TLR/reocclusion (area under the curve=0.632, P=0.001).
Conclusions
In CTO-PCI with DES, post-stent IVUS evaluation was associated with a lower risk of TLR/reocclusion. The final MSA was independently associated with TLR/reocclusion with a cut-off value of 4.9 mm2.



EuroIntervention: 15 Jan 2021; epub ahead of print
Kwon O, Lee PH, Lee SW, Brilakis ES, ... Lee CW, Park SW
EuroIntervention: 15 Jan 2021; epub ahead of print | PMID: 33589410
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Efficacy of Thin- Versus Thick-Strut Polymer-Free Biolimus-Eluting Stents: the Biofreedom QCA Randomized Trial.

Sabaté M, Okkels Jensen L, Tilsted HH, Moreno R, ... Stoll HP, Flensted Lassen J
Aims
To evaluate the efficacy of the new BioFreedom Ultra™ drug-coated stent with a thin-strut cobalt-chromium platform (BF-CoCr) compared to the BioFreedom™ drug-coated stent with a stainless-steel platform (BF-SS) in an all-comers population undergoing percutaneous coronary interventions (PCI).
Methods and results
This was a prospective, multi-center, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) as determined by quantitative coronary angiographic at 9-month follow-up. Clinical evaluation was performed at 1 year. A total of 200 patients were randomized (1:1) to either the BF-CoCr or the BF-SS stent at 8 centers in Spain and Denmark. Baseline clinical and lesion characteristics were similar among the groups. Mean age was 66 years and 23% were females. The mean number of stents implanted per patient was 1.5. At 9-month follow-up, mean in-stent LLL was 0.34±0.49mm in BF-CoCr versus 0.29±0.37mm in the BF-SS, p=0.005 for non-inferiority. At 1-year, target lesion failure was similar between groups (7.3% in Bf-CoCr vs 9.3% in the BF-SS group; p=0.60).
Conclusions
The BF-CoCr was non-inferior to the BF-SS in terms of in-stent LLL at 9 months. Larger studies powered for clinical endpoints are warranted to compare the efficacy of this new platform with currently available DES.



EuroIntervention: 11 Jan 2021; epub ahead of print
Sabaté M, Okkels Jensen L, Tilsted HH, Moreno R, ... Stoll HP, Flensted Lassen J
EuroIntervention: 11 Jan 2021; epub ahead of print | PMID: 33433389
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Angiographic predictors of outcome in myocardial infarction patients presenting with cardiogenic shock: a CULPRIT-SHOCK angiographic substudy.

Overtchouk P, Barthélémy O, Hauguel-Moreau M, Guedeney P, ... Montalescot G, Collaborators
Aims
The aim of this study was to determine the prognostic impact of pre- and post-PCI TIMI flow grade and TIMI myocardial perfusion grade (TMPG) in a well-defined group of patients with cardiogenic shock due to acute myocardial infarction.
Methods and results
Patients with infarct-related cardiogenic shock randomised into the CULPRIT-SHOCK trial were included in the angiographic predictor analysis whenever their TIMI flow grade or TMPG was available in the core lab database (96.9% of cases). A multivariable logistic regression analysis, adjusted on non-angiographic covariates, was performed to investigate whether TIMI flow grade or TMPG was independently associated with all-cause mortality or renal replacement therapy up to one year. Pre-PCI TIMI flow grade and TMPG did not impact on mortality. When analysed in separate multivariable models, post-PCI TIMI 3 flow and TMPG grade 3 were both significantly associated with reduced risk of 30-day mortality: aOR 0.61 (95% CI: 0.38-0.97, p=0.037) and 0.46 (95% CI: 0.29-0.72, p<0.001), respectively. When considered in the same multivariable model, only TMPG was significantly associated with 30-day mortality (aOR 0.38 [0.20-0.71], p=0.002), the 30-day composite of all-cause mortality and renal replacement therapy (aOR 0.34 [0.18-0.66], p=0.001) and mortality at one-year follow-up (aOR 0.46 [0.24-0.88], p=0.02).
Conclusions
Post-PCI TIMI flow grade and TMPG are associated with mortality after PCI. TMPG is a better discriminator, supporting microcirculation rather than epicardial reperfusion for prognosis estimation.



EuroIntervention: 04 Jan 2021; 16:e1237-e1244
Overtchouk P, Barthélémy O, Hauguel-Moreau M, Guedeney P, ... Montalescot G, Collaborators
EuroIntervention: 04 Jan 2021; 16:e1237-e1244 | PMID: 32624460
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Veno-arterial extracorporeal membrane oxygenation (ECMO) in patients with cardiogenic shock: rationale and design of the randomised, multicentre, open-label EURO SHOCK trial.

Banning AS, Adriaenssens T, Berry C, Bogaerts K, ... Gershlick AH, Collaborators
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 revascularisation but has plateaued since the 1990s. Once established, patients with CGS develop adverse compensatory mechanisms that contribute to the downward spiral towards death, which becomes difficult to reverse. We aimed to test in a robust, prospective, randomised controlled trial whether early support with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) provides clinical benefit by improving mortality and morbidity.
Methods and results
The EURO SHOCK trial will test the benefit or otherwise of mechanical cardiac support using VA-ECMO, initiated early after acute percutaneous coronary intervention (PCI) for CGS. The trial sets out to randomise 428 patients with CGS complicating ACS, following primary PCI (P-PCI), to either very early ECMO plus standard pharmacotherapy, or standard pharmacotherapy alone. It will be conducted in 39 European centres. 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 substudies 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: 04 Jan 2021; 16:e1227-e1236
Banning AS, Adriaenssens T, Berry C, Bogaerts K, ... Gershlick AH, Collaborators
EuroIntervention: 04 Jan 2021; 16:e1227-e1236 | PMID: 33106225
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Clinical Outcomes By Angiographic Type Of Spontaneous Coronary Artery Dissection.

Mori R, Macaya F, Giacobbe F, Salinas P, ... Escaned J, Collaborators
Background
Spontaneous coronary artery dissection (SCAD) is an increasingly diagnosed cause of myocardial infarction. Although different SCAD angiographic classifications exist, their clinical impact remains unknown.
Aims
To evaluate the relationship between an angiographic classification and the development of adverse clinical events during the follow-up of a large, unselected cohort of patients with SCAD.
Methods
We conducted an observational study of consecutive SCAD patients from 26 centers across Italy and Spain. Cases were classified into 5 different angiotypes according to the latest classification endorsed by the European Society of Cardiology. The main composite endpoint included all-cause death, non-fatal myocardial infarction (MI), and any unplanned revascularisation.
Results
In total, 302 SCAD patients (mean age 51.8±19 years) were followed up for a median of 22 months (IQR 12-48). At 28 days, the composite outcome was higher for the angiotypes with a circumscribed contained intramural hematoma (2A and 3): 20.0% vs. 5.4%, p&lt;0.001 (non-fatal MI: 11.0% vs. 3.5%, p=0.009; unplanned revascularisation: 11.0% vs. 2.5%, p&lt;0.001), which was sustained during follow-up (24.5% vs. 9.9%, p=0.001). There were no differences in mortality (0,3% overall) . The presence of an angiotype 2A or 3 was an independent predictor of a higher incidence of the composite outcome (adjusted HR: 2.44, CI 1.24-4.80, p=0.010).
Conclusions
The SCAD angiographic classification correlates with outcome. Those presenting with an angiographically circumscribed contained intramural hematoma (angiotypes 2A and 3) showed an increased risk of short-term adverse clinical events that was maintained during follow-up.



EuroIntervention: 01 Jan 2021; epub ahead of print
Mori R, Macaya F, Giacobbe F, Salinas P, ... Escaned J, Collaborators
EuroIntervention: 01 Jan 2021; epub ahead of print | PMID: 33650491
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Long-Term Safety of Drug-Coated Devices for Peripheral Revascularisation.

Secemsky EA, Barrette E, Bockstedt L, Bonaca MP, ... Manda B, Yeh RW
Aims
Meta-analyses of randomised trials of paclitaxel-coated peripheral devices found an association with worse long-term survival. We assessed long-term mortality in patients treated with drug-coated devices insured by Medicare Advantage (MA), an alternative to traditional Medicare that represents &gt;30% of the Medicare eligible population.
Methods and results
Patients treated with or without drug-coated devices for femoropopliteal artery revascularisation from 4/2015-12/2017 were studied using Optum\'s De-identified Clinformatics® Datamart Database. Mortality was assessed through December 2019 using Kaplan Meier cumulative mortality curves and Cox-proportional hazard models. Inverse probability of treatment weighting was used to adjust for differences between groups. Of 16,796 patients revascularised, 4,427 (26.4%) were treated with drug-coated devices: 3,600 (81.3%) balloons and 827 (18.7%) stents. The median follow-up was 2.66 years (IQR 2.02-3.52). Treatment with drug-coated devices was associated with similar long-term mortality as nondrug-coated devices (adjusted HR 1.03; 95%CI=0.96-1.10; P=0.39). Results were comparable for patients treated with balloons alone (adjusted HR 1.00; 95%CI=0.92-1.08; P=0.96) or stents (adjusted HR 1.02; 95%CI=0.88-1.18; P=0.78). These findings did not differ based on treatment setting, disease severity, age, sex or comorbidity burden (interaction P&gt;0.05 for all).
Conclusions
In this large cohort, there was no evidence of increased long-term mortality following treatment with drug-coated devices.



EuroIntervention: 21 Dec 2020; epub ahead of print
Secemsky EA, Barrette E, Bockstedt L, Bonaca MP, ... Manda B, Yeh RW
EuroIntervention: 21 Dec 2020; epub ahead of print | PMID: 33342764
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Transcatheter Aortic Valve Neo-Commissure Alignment with the Portico System.

Tagliari AP, Vicentini L, Zimmermann JM, Miura M, ... Maisano F, Taramasso M
Aims
Aim: To provide a step-by-step recommendation on how to align the Portico transcatheter heart valve, in a reproducible and reliable way, aiming to achieve proper neo-commissure alignment during transcatheter aortic valve implantation.
Methods and results
Patient-specific 3D aortic models were developed and printed based on CT scan reconstructions, and posteriorly positioned in a transcatheter aortic valve simulator. Neo-commissures were defined as aligned if the degree of deviation, having the native commissures as reference, was between 0-15º. The proposed neo-commissure alignment concept consists in overlapping 2 native and 2 neo-commissures in the same fluoroscopic projection, by rotating clockwise the delivery system in the descending aorta. After, the delivery system is advanced through the aortic root while the new reached orientation is kept. Neo-commissures alignment concept reproducibility and consistency were evaluated in 3 different aorta models (standard, horizontal, and anteriorized), with 2 operators performing 5 deployments in each model, counting 30 deployments in total. A successful neo-commissure alignment was achieved in all deployments (100% success).
Conclusions
Experimental tests using 3D-printed aortic root models demonstrated the feasibility and effectiveness of Portico neo-commissures alignment. The proposed orientation steps were reproducible and reliable in all the experimental deployments performed. Further animal and human studies are required to support the proposed concept.



EuroIntervention: 21 Dec 2020; epub ahead of print
Tagliari AP, Vicentini L, Zimmermann JM, Miura M, ... Maisano F, Taramasso M
EuroIntervention: 21 Dec 2020; epub ahead of print | PMID: 33342763
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Prognostic Impact and Clinical Outcomes of Coronary Flow Reserve and Hyperemic Microvascular Resistance.

Toya T, Corban MT, Park JY, Ahmad A, ... Lerman LO, Lerman A
Aims
We aimed to investigate whether coronary flow reserve (CFR) and hyperemic microvascular resistance (HMR) as continua predict major adverse cardiovascular events (MACE), comprising all-cause death, myocardial infarction, revascularization, and stroke in patients with ischemia and no obstructive coronary artery disease.
Methods and results
A total of 610 patients were included and followed-up over a median of 8.0 years (199 individual MACE in 174 patients). Both CFR and HMR as continua predicted MACE with an odds ratio (OR) of 0.70 (per 1 unit increase, 95% confidence interval [CI] [0.53, 0.92], P = 0.01) and 1.63 (per 1 mm Hg/cm/s, 95% CI [1.20, 2.21], P = 0.002), respectively. This relationship remained significant after adjustment for age and sex with an adjusted OR of 0.66 (per 1 unit increase, 95% CI [0.49, 0.89], P = 0.01) and 1.42 (per 1 mm Hg/cm/s, 95% CI [1.03, 1.94], P = 0.03). HMR added prognostic value to CFR in predicting MACE (net reclassification index 0.17, 95% CI [0.02, 0.31], P = 0.03; integrated discrimination improvement 0.01, 95% CI [0.0001, 0.02], P = 0.046).
Conclusions
Both CFR and HMR as continuous variables predict future risk of MACE.



EuroIntervention: 21 Dec 2020; epub ahead of print
Toya T, Corban MT, Park JY, Ahmad A, ... Lerman LO, Lerman A
EuroIntervention: 21 Dec 2020; epub ahead of print | PMID: 33342762
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Procedural characteristics and clinical outcomes in patients undergoing percutaneous coronary intervention for left main trifurcation disease: the EXCEL trial.

Kandzari DE, Gershlick AH, Serruys PW, Leon MB, ... Dressler O, Stone GW
Aims
Limited data exist regarding procedural and clinical outcomes of percutaneous coronary intervention (PCI) in patients with trifurcation disease of the distal left main (LM) coronary artery. We therefore aimed to examine the procedural methods and early and late outcomes among patients undergoing distal LM trifurcation versus bifurcation PCI in the EXCEL trial.
Methods and results
Patients with distal LM bifurcation disease randomised to PCI with everolimus-eluting stents in the EXCEL trial were categorised into those with and without trifurcation involvement. Angiographic and procedural characteristics in addition to clinical events up to five-year follow-up after PCI were compared. Among 605 patients with site-reported distal LM disease, 61 patients (10.1%) were identified with trifurcation anatomy. The five-year primary composite endpoint of death, myocardial infarction, or stroke occurred in 16.6% of patients with trifurcation disease compared with 22.5% of patients with distal bifurcation disease only (p=0.32). Ischaemia-driven target lesion revascularisation rates were also similar (11.9% vs 12.0%, p=0.94). No significant differences in definite or probable stent thrombosis were observed between treatment groups (1.7% vs 2.3%, p=0.76).
Conclusions
Despite the greater inherent complexity, procedural and long-term clinical outcomes following PCI of distal LM trifurcations with everolimus-eluting stents in a modest-sized cohort from the EXCEL trial were similar compared with treatment of distal LM bifurcation disease without trifurcations. These findings support PCI as a treatment strategy for selected patients with distal LM trifurcation disease. ClinicalTrials.gov Identifier: NCT01205776.



EuroIntervention: 17 Dec 2020; 16:e982-e988
Kandzari DE, Gershlick AH, Serruys PW, Leon MB, ... Dressler O, Stone GW
EuroIntervention: 17 Dec 2020; 16:e982-e988 | PMID: 31793882
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Virtual reality-assisted conscious sedation during transcatheter aortic valve implantation: a randomised pilot study.

Bruno RR, Lin Y, Wolff G, Polzin A, ... Kelm M, Jung C
Aims
Virtual reality (VR) has been used successfully in different clinical settings to treat anxiety. This prospective, randomised pilot study aimed to investigate the feasibility and safety of VR in patients undergoing conscious sedation during transfemoral transcatheter aortic valve implantation (TAVI).
Methods and results
Thirty-two patients were included and randomised to VR intervention (n=16) or control (n=16). In the intervention group, patient-selected relaxing 3D videos were projected during the TAVI procedure; pain and anxiety before and after TAVI were measured using visual analogue scales (VAS; 0-10). The median age was 83 years (IQR 78.25-87). Patients\' baseline characteristics did not differ significantly between the groups. During TAVI under conscious sedation, the median duration of VR intervention was 30.5 minutes (IQR 23.5-46); 81.3% of the patients watched the videos until device implantation, 37.5% during the whole procedure. The VR intervention group reported significantly less anxiety after the procedure (VAS 2 [IQR 0-3.75] vs 5 [IQR 2-8], p=0.04) than patients randomised to control. In the intervention group, 93.8% would use VR during TAVI again. Nausea and vomiting did not occur more frequently compared to control.
Conclusions
VR interventions during TAVI to assist conscious sedation are safe and feasible, even in very old and frail patients. In this small cohort, there was a significant reduction in periprocedural anxiety.



EuroIntervention: 17 Dec 2020; 16:e1014-e1020
Bruno RR, Lin Y, Wolff G, Polzin A, ... Kelm M, Jung C
EuroIntervention: 17 Dec 2020; 16:e1014-e1020 | PMID: 32597390
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

External applicability of the ISCHEMIA trial: an analysis of a prospective, nationwide registry of patients with stable coronary artery disease.

De Luca L, Uguccioni M, Meessen J, Temporelli PL, ... Gulizia MM, Perna GP
Aims
We sought to assess the proportion of patients eligible for the ISCHEMIA trial and to compare the characteristics and outcomes of these patients with those without ISCHEMIA inclusion or with ISCHEMIA exclusion criteria in a contemporary, nationwide cohort of patients with stable coronary artery disease (CAD).
Methods and results
Among the 5,070 consecutive patients enrolled in the START registry, 4,295 (84.7%) did not fulfil the inclusion criteria (ISCHEMIA-Not Included or ISCHEMIA-Unclassifiable), 582 (11.5%) had exclusion criteria (ISCHEMIA-Excluded), and the remaining 193 (3.8%) were classified as ISCHEMIA-Like. At one year, the incidence of the primary outcome, a composite of death from cardiovascular (CV) causes, myocardial infarction (MI), or hospitalisation for unstable angina and heart failure, was 0.5% in the ISCHEMIA-Like versus 3.3% in other patients (p=0.03). The composite secondary outcome of CV mortality and MI occurred in 0.5% of the ISCHEMIA-Like patients and in 1.4% of the remaining patients (p=0.1).
Conclusions
In a contemporary real-world cohort of stable CAD patients, only 4% resulted in being eligible for the ISCHEMIA trial. These patients presented an extremely low annual risk of adverse events, especially when compared with other groups of stable CAD patients. Visual summary. Proportion of patients with stable CAD enrolled in the START registry with or without ISCHEMIA criteria and their rate of MACE at 1 year.



EuroIntervention: 17 Dec 2020; 16:e966-e973
De Luca L, Uguccioni M, Meessen J, Temporelli PL, ... Gulizia MM, Perna GP
EuroIntervention: 17 Dec 2020; 16:e966-e973 | PMID: 32830646
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Twelve-month clinical and imaging outcomes of the uncaging coronary DynamX bioadaptor system.

Verheye S, Vrolix M, Montorfano M, Zivelonghi C, ... Abizaid AA, Colombo A
Aims
We aimed to assess 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 multicentre 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%. Up to 12 months, two target lesion failures occurred: both were cardiac deaths (day 255 and day 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 up to 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 randomised trials are required to assess the benefit of this device on events beyond one year.



EuroIntervention: 17 Dec 2020; 16:e974-e981
Verheye S, Vrolix M, Montorfano M, Zivelonghi C, ... Abizaid AA, Colombo A
EuroIntervention: 17 Dec 2020; 16:e974-e981 | PMID: 32894231
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

A randomised controlled trial of the sirolimus-eluting biodegradable polymer ultra-thin Supraflex stent versus the everolimus-eluting biodegradable polymer SYNERGY stent for three-vessel coronary artery disease: rationale and 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 the novel Supraflex Cruz stent with those of the SYNERGY stent in patients with three-vessel disease (3VD) undergoing state-of-the-art percutaneous coronary intervention (PCI).
Methods and results
In this prospective, randomised, 1:1 balanced, multicentre, open-label trial, 1,550 patients with de novo 3VD without left main disease will be assigned to the Supraflex Cruz or SYNERGY arm. The following treatment principles of \"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 optimisation by intravascular imaging, optimal pharmacological treatment and prasugrel monotherapy. The primary endpoint is a non-inferiority comparison of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any revascularisation, at 12 months post procedure. The powered secondary endpoint is a superiority comparison of the vessel-oriented composite endpoint (VOCE), defined as vessel-related cardiovascular death, vessel-related myocardial infarction, or clinically and physiologically indicated target vessel revascularisation, 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 SYNERGY stents. Clinical
Trial registration:
URL: https://www.clinicaltrials.gov/ct2/show/NCT04390672. Unique Identifier: NCT04390672 Visual summary. Flow chart of the Multivessel TALENT trial. 3VD: three-vessel disease; QFR: quantitative flow ratio; IVUS: intravascular ultrasound; OCT: optical coherence tomography; CTO: chronic total occlusion; OMT: optimal medical therapy; POCE: patient-oriented composite endpoint; VOCE: vessel-oriented composite endpoint.



EuroIntervention: 17 Dec 2020; 16:e997-e1004
Hara H, Gao C, Kogame N, Ono M, ... Onuma Y, Serruys PW
EuroIntervention: 17 Dec 2020; 16:e997-e1004 | PMID: 32928717
Go to: DOI | PubMed | PDF | Google Scholar |
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
The aim of this study was to investigate the risk of impaired coronary access and coronary obstruction after redo TAVI.
Methods and results
Post-procedure multidetector computed tomography (MDCT) scans of 221 TAVI recipients were analysed. Increased risk of impaired coronary access was defined as a coronary ostium below the TAVI commissures with a valve-to-aorta distance <2 mm at this level. Increased risk was found in 123 (55.6%) cases: the left main was involved in 109 (49.3%), the right coronary in 79 (35.7%), and both were involved in 65 (29.4%) patients. A small sinotubular 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 a coronary ostium below the TAVI commissures with a valve-to-coronary distance <2 mm, was observed in 14.9% of patients; in 17.2% of cases complete sealing of the STJ would occur.
Conclusions
Post-TAVI MDCT suggested an increased potential risk of impaired coronary access in more than half of the patients should redo TAVI be required, predicted by a 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. Visual summary. Aortic root in native anatomy (A), after TAVI (B) and after redo TAVI (C): small sinotubular junction and high leaflets of the transcatheter heart valve, pushed up and outwards by the second device, are associated with impaired coronary access and perfusion after redo TAVI.



EuroIntervention: 17 Dec 2020; 16:e1005-e1013
Buzzatti N, Montorfano M, Romano V, De Backer O, ... Colombo A, Latib A
EuroIntervention: 17 Dec 2020; 16:e1005-e1013 | PMID: 32928715
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Coronary sinus narrowing for the treatment of refractory angina A multi-center prospective open-label clinical study (The REDUCER-I study).

Verheye S, Agostoni P, Giannini F, Hill JM, ... Banai S, Konigstein M
Aims
To examine the safety and efficacy of the coronary sinus (CS) Reducer in improving angina severity and quality of life in patients suffering from angina pectoris, refractory to medical and interventional therapies.
Methods and results
Patients with refractory angina pectoris (n=228; 81% male, 68.3±9.6 years) were enrolled to this multi-center,open label study, with up to 2 year follow-up. Patients with Canadian Cardiovascular Society (CCS) class 2-4 were treated with Reducer implantation in the CS. Procedural success rate was 99%, with only one adjudicated possible procedural or device-related MACE. Mean CCS class decreased from 2.8±0.6 at baseline to 1.8±0.7 at 24-month (p&lt;0.0001). Improvement in ≥1 CCS class was observed in 82%, and in ≥2 CCS classes in 31% of patients at 2 years. Disabling angina (CCS 3-4), affected 70% of the cohort at baseline and only 15% at follow up. Additional measured parameters of functional class and quality of life were also improved.
Conclusions
Interim results from the ongoing REDUCER-I study confirm the high safety profile of this therapy in patients suffering from refractory angina. The results also demonstrate sustained improvement in angina severity and in quality of life out to 2 years.



EuroIntervention: 14 Dec 2020; epub ahead of print
Verheye S, Agostoni P, Giannini F, Hill JM, ... Banai S, Konigstein M
EuroIntervention: 14 Dec 2020; epub ahead of print | PMID: 33319762
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Near-infrared spectroscopy carotid plaque characteristics and cerebral embolism in carotid artery stenting using first-generation stent.

Nakagawa I, Kotsugi M, Park HS, Furuta T, ... Motoyama Y, Nakase H
Aims
Perioperative thromboembolism is the main consideration in carotid artery stenting (CAS). This study aimed to determine whether high lipid core plaque (LCP) assessed by catheter-based near-infrared spectroscopy (NIRS) is associated with ipsilateral cerebral embolism by diffusion-weighted magnetic resonance imaging during CAS using a first-generation stent.
Methods and results
Carotid stenosis magnetic resonance (MR) T1-weighted plaque signal intensity ratio (T1W-SIR) followed by NIRS assessment at the time of CAS (using Carotid Wallstent) was performed in 117 consecutive patients. The maximum lipid core burden index (max-LCBI) at minimal luminal areas (MLA; max-LCBI MLA ) and max-LCBI for any 4-mm segment in a target lesion defined as max-LCBI area were significantly higher for the post-procedural new ipsilateral diffusion-weighted magnetic resonance imaging (DWI)-positive than negative patients ( p &lt;0.001 for all). There was a significant linear correlation between max-LCBI area and the number of new emboli (r = 0.544, p &lt; 0.0001). We also found that the second quantile (Q2) of T1W-SIR MLA had a significantly higher max-LCBI MLA and a higher incidence of DWI positivity than Q1 and Q3 ( p &lt; 0.001 for all). Furthermore, max-LCBI MLA appeared to distinguish between patients with and without postoperative new ipsilateral DWI positivity (AUC, 0.91; 95% CI, 0.86 - 0.96; p &lt; 0.0001).
Conclusions
High LCP assessed by NIRS is associated with cerebral embolism by diffusion-weighted imaging in CAS using a first-generation stent.



EuroIntervention: 07 Dec 2020; epub ahead of print
Nakagawa I, Kotsugi M, Park HS, Furuta T, ... Motoyama Y, Nakase H
EuroIntervention: 07 Dec 2020; epub ahead of print | PMID: 33283761
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Impact of bioresorbable scaffold design characteristics on local haemodynamic forces: an ex vivo assessment with computational fluid dynamics simulations.

Tarrahi I, Colombo M, Hartman EMJ, Tovar Forero MN, ... Daemen J, Gijsen FJH
Aims
Bioresorbable scaffold (BRS) regions exposed to flow recirculation, low time-averaged wall shear stress (TAWSS) and high oscillatory shear index (OSI) develop increased neointima tissue. We investigated haemodynamic features in four different BRSs.
Methods and results
Fantom (strut height [SH] = 125 µm), Fantom Encore (SH = 98 µm), Absorb (SH = 157 µm) and Magmaris (SH = 150 µm) BRSs were deployed in phantom tubes and imaged with microCT. Both 2D and 3D geometrical scaffold models were reconstructed. Computational fluid dynamics (CFD) simulation was performed to compute TAWSS and OSI. Thicker struts had larger recirculation zones and lower TAWSS in 2D. Absorb had the largest recirculation zone and the lowest TAWSS (240 µm and -0.18 Pa), followed by Magmaris (170 µm and -0.15 Pa), Fantom (140 µm and -0.14 Pa) and Fantom Encore (100 µm and -0.13 Pa). Besides strut size, stent design played a dominant role in 3D. The highest percentage area adverse TAWSS (<0.5 Pa) and OSI (>0.2) were found for Fantom (56% and 30%) and Absorb (53% and 33%), followed by Fantom Encore (30% and 25%) and Magmaris (25% and 20%). Magmaris had the smallest areas due to a small footprint and rounded struts.
Conclusions
Due to stent design, both Fantom Encore and Magmaris showed smaller TAWSS and OSI than Fantom and Absorb. This study quantifies which scaffold features are most important to reduce long-term restenosis.



EuroIntervention: 03 Dec 2020; 16:e930-e937
Tarrahi I, Colombo M, Hartman EMJ, Tovar Forero MN, ... Daemen J, Gijsen FJH
EuroIntervention: 03 Dec 2020; 16:e930-e937 | PMID: 31951204
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

WATCHMAN versus ACP or Amulet devices for left atrial appendage occlusion: a sub-analysis of the multicentre LAARGE registry.

Ledwoch J, Franke J, Akin I, Geist V, ... Brachmann J, Sievert H
Aims
Several left atrial appendage (LAA) closure systems are available. Due to differences in device design, the results of specific occluders derived from trials cannot simply be generalised to all devices. The present analysis sought to assess two contemporary LAA closure devices in clinical practice.
Methods and results
The work represents a non-randomised sub-analysis of the prospective, multicentre, Left-Atrium-Appendage Occluder Register - GErmany (LAARGE) registry. The WATCHMAN (group 1) and the AMPLATZER Cardiac Plug (ACP) or Amulet occluder (group 2) were assessed. A total of 641 patients at 38 centres were enrolled. Of these, 278 (43%) and 340 (53%) patients received the WATCHMAN and ACP/Amulet occluder, respectively. High technical success was achieved with a slight difference between the groups (96% in group 1 vs 99% in group 2; p=0.007). Procedural safety did not differ (98% in group 1 vs 97% in group 2; p=0.55). The Kaplan-Meier estimated one-year composite of death or stroke was 12.0% and 12.9%, respectively (p=0.79).
Conclusions
Both the WATCHMAN and the ACP/Amulet occluder provide excellent procedural results with comparable implantation success and no differences with respect to procedural safety and long-term effectiveness.



EuroIntervention: 03 Dec 2020; 16:e942-e949
Ledwoch J, Franke J, Akin I, Geist V, ... Brachmann J, Sievert H
EuroIntervention: 03 Dec 2020; 16:e942-e949 | PMID: 32451320
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Preclinical investigation of neoatherosclerosis in magnesium-based bioresorbable scaffolds versus thick-strut drug-eluting stents.

Nicol P, Bulin A, Castellanos MI, Stöger M, ... Haude M, Joner M
Aims
Neoatherosclerosis is a frequent finding after implantation of permanent metallic stents. Bioresorbable scaffolds (BRS) are considered to reduce the incidence of neoatherosclerosis owing to their dissolution and consequent vascular restoration. The aim of this study was to evaluate the formation of neoatherosclerosis between magnesium-based BRS and thick-strut metallic drug-eluting stents (DES) in a rabbit model of neoatherosclerosis and in proportion to the effect of high-dose statin medication.
Methods and results
Fully bioresorbable magnesium scaffolds (BRS, n=45) and thick-strut permanent metallic DES of equivalent geometry and design (n=45) were implanted into the iliac arteries of New Zealand White rabbits (n=45) following endothelial balloon injury and exposure to a cholesterol diet. Endothelialisation was assessed in 12 animals after 35 days using scanning electron microscopy (SEM), showing significantly enhanced re-endothelialisation above struts in the BRS (n=13) compared to DES (n=10). Eleven (11) animals were terminated for baseline assessment after 91 days while the remaining 22 animals were randomised to receive high-dose statin treatment (3 mg/kg) or placebo. BRS-treated vessels showed a significant reduction in foam cell infiltration as a sign of early neoatherosclerosis by histology and OCT when compared to thick-strut DES-treated vessels. Statin treatment resulted in significant reduction of foam cell infiltration in BRS and DES by histology.
Conclusions
Our findings suggest reduced neoatherosclerosis formation in magnesium-based BRS relative to thick-strut DES. High-dose statin treatment may be a promising measure to reduce neoatherosclerosis progression, both on its own and in synergy with site-targeted device-based treatment.



EuroIntervention: 03 Dec 2020; 16:e922-e929
Nicol P, Bulin A, Castellanos MI, Stöger M, ... Haude M, Joner M
EuroIntervention: 03 Dec 2020; 16:e922-e929 | PMID: 32583804
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Management of myocardial revascularisation failure: an expert consensus document of the EAPCI.

Stefanini GG, Alfonso F, Barbato E, Byrne RA, ... Wijns W, Baumbach A
Myocardial revascularisation represents the most frequently performed therapeutic intervention worldwide. Current percutaneous and surgical revascularisation techniques provide excellent short- and long-term clinical outcomes. However, despite the technological and procedural advances with the widespread use of drug-eluting stents and arterial bypass grafts in contemporary practice, a considerable proportion of patients require repeat revascularisation procedures during long-term follow-up. The need for repeat revascularisation has a major impact on patients\' quality of life and is associated with a significant economic burden. This consensus document summarises the views on the management of myocardial revascularisation failure of an expert panel of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). The present document provides a broad and pragmatic overview of the clinical management of myocardial revascularisation failure with a focus on the three key underlying mechanisms leading to repeat revascularisation: 1) failure of percutaneous coronary interventions, 2) failure of coronary artery bypass grafting, and 3) progression of coronary artery disease in native coronary segments previously untreated. The aim of the present position document is to provide a patient-oriented approach for the management of myocardial revascularisation failure.



EuroIntervention: 03 Dec 2020; 16:e875-e890
Stefanini GG, Alfonso F, Barbato E, Byrne RA, ... Wijns W, Baumbach A
EuroIntervention: 03 Dec 2020; 16:e875-e890 | PMID: 32597391
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:

This program is still in alpha version.