Journal: EuroIntervention

Sorted by: date / impact
Abstract

Tangential signal dropout artefact in optical frequency domain imaging.

Shibutani H, Fujii K, Kawakami R, Imanaka T, ... Hirota S, Shiojima I
Background
Tangential signal dropout (TSD), which occurs when the optical frequency domain imaging (OFDI) beam strikes the vessel wall under a glancing angle and travels almost parallel to the vessel wall, is the most important imaging artefact leading to the erroneous diagnosis of lipid-rich plaques.
Aims
This study aimed to evaluate the OFDI artefact of TSD, which mimics the appearance of lipid-rich plaque and macrophage (Mø) infiltration.
Methods
A total of 1,019 histological cross-sections from 23 autopsy hearts were matched with the corresponding OFDI images. Of these, 232 OFDI cross-sections that contained signal-poor regions with diffuse borders were classified as lipid-rich plaques. The angle θ was calculated between the OFDI beam that strikes the edge of the luminal surface of the low-intensity region and that which strikes the surface line of the low-intensity region.
Results
On histological evaluation, 182 (78%) cross-sections were classified as histologically lipidic/Mø infiltration, while the remaining 50 (22%) cross-sections were classified as histologically non-lipidic/Mø infiltration. The angle θ was significantly smaller in the non-lipidic/Mø infiltration group than in the lipidic/Mø infiltration group (12±6° versus 37±14°, p<0.001). Receiver operating curve analysis revealed that the optimal cut-off value of the incident angle for predicting TSD was 23° with an area under the curve of 0.98.
Conclusions
When the OFDI imaging beam strikes the tissue at an angle θ<23°, TSD artefact could occur. To eliminate image misinterpretation, our findings suggest that the OFDI catheter geometry should be considered for the accurate diagnosis of lipid-rich plaques and Mø infiltration.



EuroIntervention: 19 Jul 2021; 17:e326-e331
Shibutani H, Fujii K, Kawakami R, Imanaka T, ... Hirota S, Shiojima I
EuroIntervention: 19 Jul 2021; 17:e326-e331 | PMID: 32338609
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Abstract

Clinical outcomes of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention By Coronary Flow Capacity Status in Stable Lesions.

Hamaya R, Lee JM, Hoshino M, Yonetsu T, ... Escaned J, Kakuta T
Background
Coronary flow capacity (CFC) provides integrated information about coronary flow reserve (CFR) and hyperaemic coronary flow and is useful for identifying coronary flow limitation.
Aims
The aim of this study was to investigate the effect of percutaneous coronary intervention (PCI) on vessel-related major adverse cardiovascular events (MACE) according to CFC status in stable coronary lesions.
Methods
From a global, multicentre registry of comprehensive physiological assessment, a total of 1,397 patients (1,694 vessels) were analysed. Low CFC was defined for lesions with reduced CFR and inverse of hyperaemic mean transit time (1/hTmn). A predefined definition of CFC (CFR <2.0 and 1/hTmn less than the corresponding percentile) was assessed first in a multivariable marginal Cox proportional model with the interaction term between CFC status and PCI (performed or not), and then the optimal definition of CFC was explored.
Results
We observed a significant interaction between predefined low CFC and PCI (p=0.067). With the optimal definition of CFC (CFR ≤3.2 and 1/hTmn ≤2.8), the HR (95% CI) of PCI was 0.278 (0.103-0.751) and 1.393 (0.783-2.478) in lesions with low and normal CFC, respectively. If lesions with fractional flow reserve (FFR) ≤0.8 and normal CFC had been deferred, the number of PCI would have decreased by 64%.
Conclusions
FFR-guided PCI for low CFC lesions was associated with reduced incidence of MACE in low CFC but not in normal CFC lesions. Our results suggest the potential use of CFC in combination with FFR for optimising the indication for PCI by reducing potentially unbeneficial PCI.
Clinical trials registration
https://clinicaltrials.gov/ct2/show/NCT03690713.



EuroIntervention: 19 Jul 2021; 17:e301-e308
Hamaya R, Lee JM, Hoshino M, Yonetsu T, ... Escaned J, Kakuta T
EuroIntervention: 19 Jul 2021; 17:e301-e308 | PMID: 32624458
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Abstract

Normal values of thermodilution-derived absolute coronary blood flow and microvascular resistance in humans.

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



EuroIntervention: 19 Jul 2021; 17:e309-e316
Fournier S, Keulards DCJ, van 't Veer M, Colaiori I, ... Pijls NHJ, De Bruyne B
EuroIntervention: 19 Jul 2021; 17:e309-e316 | PMID: 33016881
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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 the 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 two-year outcomes in HF patients with reduced LV ejection fraction (HFrEF; LVEF ≤40%) versus preserved LVEF (HFpEF; LVEF >40%) and in those with severe (LVEF ≤30%) versus moderate (LVEF >30%) LV dysfunction.
Methods
The principal effectiveness outcome was the two-year rate of death from any cause or HF hospitalisations (HFH). Subgroup analysis with interaction testing was 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 >30%; mean LVEF 39.0%±6.8%).
Results
The two-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 two-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 six-minute walk distance in patients with HFrEF, HFpEF, LVEF ≤30%, and LVEF >30%.
Conclusions
In the COAPT trial, among patients with HF and 3+ or 4+ SMR who remained symptomatic despite maximally tolerated GDMT, the MitraClip was consistently effective in improving survival and health status in patients with severe and moderate LV dysfunction and those with preserved LVEF.



EuroIntervention: 19 Jul 2021; 17:e335-e342
Lerakis S, Kini AS, Asch FM, Kar S, ... Mack MJ, Stone GW
EuroIntervention: 19 Jul 2021; 17:e335-e342 | PMID: 33589408
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Abstract

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

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



EuroIntervention: 19 Jul 2021; 17:e343-e352
Schlotter F, Miura M, Kresoja KP, Alushi B, ... Taramasso M, Lurz P
EuroIntervention: 19 Jul 2021; 17:e343-e352 | PMID: 33956637
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Abstract

Principles and pitfalls in coronary vasomotor function testing.

Feenstra R, Seitz A, Boerhout C, Bukkems L, ... Ong P, Beijk MA
Background
Coronary vasomotor dysfunction can be diagnosed in a large proportion of patients with angina in the presence of non-obstructive coronary artery disease (ANOCA) using comprehensive protocols for coronary vasomotor function testing. Although consensus on diagnostic criteria for endotypes of coronary vasomotor dysfunction have been published, consensus on a standardised study testing protocol is lacking.
Aims
In this review we provide an overview of the variations in coronary vasomotor function testing used and discuss the practical principles and pitfalls of coronary vasomotor function testing.
Methods
For the purpose of this review we assessed study protocols that evaluate coronary vasomotor response as reported in the literature. We compared these protocols regarding a number of procedural aspects and chose six examples to highlight the differences and uniqueness.
Results
Currently, numerous protocols co-exist and vary in vascular domains tested, the manner to test these domains (e.g. pre-procedural discontinuation of medication, provocative agent, solution, infusion time, and target artery) and techniques used for measurements (e.g. doppler vs thermodilution technique).
Conclusions
This lack of consensus on a uniform functional testing protocol hampers both a broader clinical acceptance of the concepts of coronary vasomotor dysfunction, and the widespread adoption of such testing protocols in current clinical practice. Furthermore, the endotype of coronary vasomotor dysfunction might differ between the few specialised centres that perform coronary vasomotor function testing as a result of the use of different protocols. In this review we provide an overview of the variations in coronary vasomotor function testing used and discuss the practical principles and pitfalls of coronary vasomotor function testing.



EuroIntervention: 19 Jul 2021; epub ahead of print
Feenstra R, Seitz A, Boerhout C, Bukkems L, ... Ong P, Beijk MA
EuroIntervention: 19 Jul 2021; epub ahead of print | PMID: 34278990
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Abstract

Chronic Hemodynamic Performance of a Biorestorative Transcatheter Heart Valve in an Ovine Model.

Serruys PW, Kawashima H, Chang CC, Modolo R, ... Flameng W, Soliman O
Background
The Xeltis biorestorative transcatheter heart valve (BTHV) leaflets are made from an eletrospun bioabsorbable supramolecular polycarbonate-urethane and are mounted on a self-expanding nitinol frame. Acute hemodynamic performance of this BTHV was favorable.
Aims
We sought to demonstrate preclinical feasibility of a novel BTHV by evaluating the hemodynamic performances of 5 pilot valve designs up to 12 months in a chronic ovine model.
Methods
Five design iterations (A, B, B\', C, and D) of the BTHV were transapically implanted in 46 sheep; chronic data were available in 39 animals. Assessments were performed at implantation, 3-, 6-, and 12-months including quantitative aortography, echocardiography, and histology.
Results
At 12-months, greater than or equal to moderate AR on echocardiography was seen in 0%, 100%, 33.3%, 100%, and 0% in the iterations A, B, B\', C, and D, respectively. Furthermore, transprosthetic mean gradients on echocardiography was 10.0±2.8mmHg, 19.0±1.0mmHg, 8.0±1.7mmHg, 26.8±2.4mmHg, and 11.2±4.1mmHg, and effective orifice area was 0.7±0.3cm2, 1.1±0.3cm2, 1.5±1.0cm2, 1.5±0.6cm2, and 1.0±0.4cm2 in the iterations A, B, B\', C, and D, respectively. On pathological evaluation, the iteration D demonstrated generally intact leaflets and advanced tissue coverage, while different degrees of structural deterioration were observed in the other design iterations.
Conclusions
Several leaflet material iterations were compared for potential to demonstrate endogenous tissue restoration in an aortic valve in-vivo. The most promising iteration showed intact leaflets and acceptable hemodynamic performance at 12 months, illustrating the potential of BTHV.



EuroIntervention: 19 Jul 2021; epub ahead of print
Serruys PW, Kawashima H, Chang CC, Modolo R, ... Flameng W, Soliman O
EuroIntervention: 19 Jul 2021; epub ahead of print | PMID: 34278989
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Abstract

Changes in blood pressure after crossover to ultrasound renal denervation in patients initially treated with sham in the RADIANCE-HTN SOLO trial.

Mahfoud F, Bloch MJ, Azizi M, Wang Y, ... McClure CK, Kirtane AJ
Background
The multicentre, randomised, sham-controlled RADIANCE-HTN SOLO trial reported the blood pressure (BP)-lowering efficacy and safety of ultrasound renal denervation (RDN) in the absence (2 months) and presence (6 and 12 months) of antihypertensive medications in patients with mild-to-moderate hypertension.
Aims
The aim of this report was to evaluate patients originally assigned to the sham group who crossed over to RDN.
Methods
After the primary endpoint was met, patients in the sham arm who remained uncontrolled were allowed to cross over to receive RDN. All patients were unblinded and treated with standard of care medications at the time of crossover. Ambulatory BP was evaluated 2 and 6 months after crossover.
Results
Among 72 subjects of the sham arm, 33 underwent ultrasound RDN after an average follow-up of 23±6 months. Prior to crossover, patients had a daytime ambulatory BP of 144.1±10.1/89.9±8.4 mmHg and received 1.2±0.8 antihypertensive medications. Mean change in daytime ambulatory BP from pre-crossover to 2 and 6 months post RDN was -11.2±13.7/-7.1±8.9 mmHg (n=33; p&lt;0.001; p&lt;0.001) and -10.8±17.3/-7.8±11.6 mmHg (n=27; p=0.002; p&lt;0.001). The number of antihypertensive medications did not change from pre-crossover baseline to 2 and 6 months. Eighteen of 33 (54.5%) patients had their daytime ambulatory BP controlled (&lt;135/85 mmHg) at 2 months and 44.4% (12/27) at 6 months post RDN. No major procedure-related adverse events occurred.
Conclusions
During unblinded long-term follow-up of the RADIANCE-HTN SOLO study, patients originally assigned to a sham procedure who remained uncontrolled had significant reductions in BP following crossover treatment with ultrasound RDN.



EuroIntervention: 08 Jul 2021; epub ahead of print
Mahfoud F, Bloch MJ, Azizi M, Wang Y, ... McClure CK, Kirtane AJ
EuroIntervention: 08 Jul 2021; epub ahead of print | PMID: 34236037
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Abstract

Geographical variations in left main coronary artery revascularisation: a pre-specified analysis of the EXCEL trial.

Myat A, Hildick-Smith D, de Belder AJ, Trivedi U, ... Sabik JF, Stone GW
Background
The EXCEL trial reported similar five-year rates of the primary composite outcome of death, myocardial infarction (MI), or stroke after percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG) for treatment of obstructive left main coronary artery disease (LMCAD).
Aims
We sought to determine whether these outcomes remained consistent regardless of geography of enrolment.
Methods
We performed a pre-specified subgroup analysis based on regional enrolment.
Results
Among 1,905 patients randomised to PCI (n=948) or CABG (n=957), 1,075 (56.4%) were recruited at 52 European Union (EU) centres, and 752 (39.5%) were recruited at 67 North American (NA) centres. EU versus NA patients varied according to numerous baseline demographics, anatomy, pharmacotherapy and procedural characteristics. Nonetheless, the relative rates of the primary endpoint after PCI versus CABG were consistent across EU versus NA centres at 30 days and 5 years. However, NA participants had substantially higher late rates of ischaemia-driven revascularisation (IDR) after PCI, driven predominantly by the need for greater target vessel and lesion revascularisation. This culminated in a significant difference in the relative risk of the secondary composite outcome of death, MI, stroke, or IDR at 5 years (pinteraction=0.02).
Conclusions
In the EXCEL trial, the relative risks for the 30-day and five-year primary composite outcome of death, MI or stroke after PCI versus CABG were consistent irrespective of geography. However, five-year rates of IDR after PCI were significantly higher in NA centres, a finding the Heart Team and patients should consider when making treatment decisions. ClinicalTrials.gov identifier: NCT01205776.



EuroIntervention: 01 Jul 2021; epub ahead of print
Myat A, Hildick-Smith D, de Belder AJ, Trivedi U, ... Sabik JF, Stone GW
EuroIntervention: 01 Jul 2021; epub ahead of print | PMID: 34212863
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Abstract

Thermodilution-derived temperature recovery time: a novel predictor of microvascular reperfusion and prognosis after myocardial infarction.

Maznyczka AM, Carrick D, Oldroyd KG, James-Rae G, ... Petrie MC, Berry C
Background
Novel parameters that detect failed microvascular reperfusion might identify better the patients likely to benefit from adjunctive treatments during primary percutaneous coronary intervention (PCI).
Aims
The aim of this study was to test the hypothesis that a novel invasive parameter, the thermodilution-derived temperature recovery time (TRT), would be associated with microvascular obstruction (MVO) and prognosis.
Methods
TRT was derived and validated in two independent ST-elevation myocardial infarction populations and was measured immediately post PCI. TRT was defined as the duration (seconds) from the nadir of the hyperaemic thermodilution curve to 20% from baseline body temperature. MVO extent (% left ventricular mass) was assessed by cardiovascular magnetic resonance imaging at 2-7 days.
Results
In the retrospective derivation cohort (n=271, mean age 60±12 years, 72% male), higher TRT was associated with more MVO (coefficient: 4.09 [95% CI: 2.70-5.48], p<0.001), independently of IMR >32, CFR ≤2, hyperaemic Tmn >median, thermodilution waveform, age and ischaemic time. At five years, higher TRT was multivariably associated with all-cause death/heart failure hospitalisation (OR 4.14 [95% CI: 2.08-8.25], p<0.001) and major adverse cardiac events (OR 4.05 [95% CI: 2.00-8.21], p<0.001). In the validation population (n=144, mean age 59±11 years, 80% male), the findings were confirmed prospectively.
Conclusions
TRT represents a novel diagnostic advance for predicting MVO and prognosis. ClinicalTrials.gov Identifiers: NCT02072850 & NCT02257294 Visual summary. Thermodilution-derived temperature recovery time (TRT): a novel predictor of microvascular reperfusion & prognosis after STEMI. CMR: cardiovascular magnetic resonance; MACE: major adverse cardiac events; MVO: microvascular obstruction; PCI: percutaneous coronary intervention; STEMI: ST-segment elevation myocardial infarction.



EuroIntervention: 24 Jun 2021; 17:220-228
Maznyczka AM, Carrick D, Oldroyd KG, James-Rae G, ... Petrie MC, Berry C
EuroIntervention: 24 Jun 2021; 17:220-228 | PMID: 32122822
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Abstract

Comparison of acute thrombogenicity and albumin adsorption in three different durable polymer coronary drug-eluting stents.

Jinnouchi H, Kutyna M, Torii S, Cheng Q, ... Virmani R, Finn AV
Background
The relative thrombogenicity and albumin adsorption and retention of different durable polymers used in coronary stents has not been tested.
Aims
This study sought to compare the thromboresistance and albumin binding capacity of different durable polymer drug-eluting stents (DES) using dedicated preclinical and in vitro models.
Methods
In an ex vivo swine arteriovenous shunt model, a fluoropolymer everolimus-eluting stent (FP-EES) (n=14) was compared with two durable polymer DES, the BioLinx polymer-coated zotarolimus-eluting stent (BL-ZES) (n=9) and a CarboSil elastomer polymer-coated ridaforolimus-eluting stent (EP-RES) (n=6), and bare metal stents (BMS) (n=10). Stents underwent immunostaining using a cocktail of antiplatelet antibodies and a marker for inflammation and were then evaluated by confocal microscopy (CM). Albumin retention was assessed using a flow loop model with labelled human serum albumin (FP-EES [n=8], BL-ZES [n=4], EP-RES [n=4], and BMS [n=7]), and scanned by CM.
Results
The area of platelet adherence (normalised to total stent surface area) was lower in the order FP-EES (9.8%), BL-ZES (32.7%), EP-RES (87.6%) and BMS (202.0%), and inflammatory cell density was least for FP-EES <BL-ZES <EP-RES <BMS. Although nearly full coverage by albumin binding was shown for all durable polymer DES, FP-EES showed significantly greater intensity of albumin as compared to BL-ZES, EP-RES and BMS (FP-EES 79.0%; BL-ZES 13.2%; EP-RES 6.1%; BMS 1.5%).
Conclusions
These results suggest that thromboresistance and albumin retention vary by polymer type and that these differences might result in different suitability for short-term dual antiplatelet therapy.



EuroIntervention: 24 Jun 2021; 17:248-256
Jinnouchi H, Kutyna M, Torii S, Cheng Q, ... Virmani R, Finn AV
EuroIntervention: 24 Jun 2021; 17:248-256 | PMID: 32149708
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Abstract

Outcomes of directional atherectomy for common femoral artery disease.

Böhme T, Romano L, Macharzina RR, Noory E, ... Zeller T, Rastan A
Background
Endovascular therapy is the first-line strategy for femoropopliteal obstructive disease. However, for lesions involving the common femoral artery (CFA) surgical endarterectomy is still the gold standard.
Aims
The aim of this study was to evaluate the safety and efficacy of directional atherectomy (DA) for the treatment of CFA lesions.
Methods
A retrospective analysis of patients who underwent DA of the CFA between March 2009 and June 2017 was performed. The primary efficacy endpoint was the incidence of clinically driven target lesion revascularisation (cdTLR). Secondary endpoints included the overall procedural complication rate at 30 days, change in ankle-brachial index (ABI), and Rutherford-Becker class (RBC) during follow-up.
Results
This analysis included 250 patients. The mean follow-up period was 31.03±21.56 months (range 1-88, median follow-up period 25 months). The procedural complication rate including access-site complications, target lesion perforation, and outflow embolisation was 10.4% (n=26). All but one complication could be treated conservatively or endovascularly. One surgical revision was necessary. Freedom from major adverse events (death, cdTLR, myocardial infarction and major target limb amputation) at 30 days was 99.6%. The rate of cdTLR during follow-up was 13.6% (n=34). A significant improvement of the mean ABI and the RBC was observed. Multivariate logistic regression analysis revealed residual target lesion stenosis >30% (p=0.005), and heavy calcification of the target lesion (p=0.033) to be independent predictors for cdTLR.
Conclusions
The use of DA for the treatment of CFA lesions leads to promising midterm results with an acceptable complication rate.



EuroIntervention: 24 Jun 2021; 17:260-266
Böhme T, Romano L, Macharzina RR, Noory E, ... Zeller T, Rastan A
EuroIntervention: 24 Jun 2021; 17:260-266 | PMID: 32176618
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Abstract

Acute and one-year clinical outcomes of pre-stenting intravascular ultrasound: a patient-level meta-analysis of randomised clinical trials.

Hong SJ, Kim D, Kim BK, Ahn CM, ... Hong MK, Jang Y
Background
Pre-stenting intravascular ultrasound (IVUS) assessment is helpful for appropriate stent sizing and determination of the stent landing zone during percutaneous coronary intervention.
Aims
The aim of this meta-analysis was to investigate the effect of pre-stenting IVUS evaluation on procedural and clinical outcomes for diffuse lesions treated with drug-eluting stents (DES).
Methods
In four randomised trials comparing IVUS- and angiography-guided DES placement, a total of 1,396 patients who underwent DES implantation with IVUS guidance were identified. Pre-stenting IVUS assessment was performed in 905 patients along with post-stenting IVUS (65%; pre-stenting IVUS(+) group). Post-stenting IVUS evaluation alone was conducted on 491 patients (35%; pre-stenting IVUS(-) group).
Results
The pre-stenting IVUS(+) group had a larger angiographic minimal lumen diameter and IVUS-derived minimal stent area (MSA) than did the pre-stenting IVUS(-) group. After adjusting, these findings were consistent. The one-year composite of cardiac death, myocardial infarction, and target vessel revascularisation did not differ between the groups. In subgroup analysis, the pre-IVUS(+) group was significantly favoured over the pre-IVUS(-) group in the subset of patients with acute myocardial infarction and lesions with small vessels in terms of larger MSA, and in the subset of patients with chronic total occlusions in terms of better clinical outcomes.
Conclusions
Pre-stenting IVUS assessment prior to DES placement was associated with better acute procedural outcomes, though this did not translate into one-year clinical outcomes in the context of post-stenting IVUS assessment. Visual summary. Acute and one-year outcomes of pre-stenting intravascular ultrasound: a meta-analysis of randomised clinical trials.



EuroIntervention: 24 Jun 2021; 17:202-211
Hong SJ, Kim D, Kim BK, Ahn CM, ... Hong MK, Jang Y
EuroIntervention: 24 Jun 2021; 17:202-211 | PMID: 32364499
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Abstract

Drug-coated stents versus bare metal stents in Academic Research Consortium-defined high bleeding risk patients.

Marquis-Gravel G, Urban P, Copt S, Capodanno D, ... Morice MC, Krucoff MW
Background
More effective and progressively safer generations of drug-elut-ing stents (DES) have replaced bare metal stents (BMS) in rou-tine clinical practice. However, patients considered to be at high bleeding risk (HBR) have traditionally been underrepresented in pivotal DES trials.
Aims
The aim of this study was to model the safety and effectiveness of drug-coated stents (DCS) versus BMS in HBR patients according to the Academic Research Consortium (ARC) criteria.
Methods
Participants from the LEADERS FREE (LF) and LEADERS FREE II (LFII) studies were pooled into one data set. Participants were treated with 30 days of DAPT. The primary safety (composite of cardiac death, myocardial infarction, or stent thrombosis) and effectiveness (target lesion revascularisation) endpoints were compared between DCS and BMS in the subgroup of patients satisfying the ARC-HBR definition using propensity-score modelling.
Results
From the 3,635 participants included in the combined LF and LFII data set, 2,898 (79.7%) satisfied the ARC-HBR criteria (DCS: 1,923; BMS: 975). The primary safety endpoint occurred in 184 (9.8%) and in 132 (13.8%) participants in the DCS and BMS groups, respectively (adjusted HR 0.72, 95% CI: 0.57-0.91; p=0.006). The risk of the primary effectiveness endpoint was also significantly lower with DCS (6.2%) versus BMS (8.8%) (adjusted HR 0.70, 95% CI: 0.52-0.94; p=0.016). The safety and effectiveness of DCS versus BMS were consistent according to ARC-HBR status (p for interaction=0.206 and 0.260, respectively).
Conclusions
DCS are safer and more effective than BMS in an ARC-defined HBR population.



EuroIntervention: 24 Jun 2021; 17:240-247
Marquis-Gravel G, Urban P, Copt S, Capodanno D, ... Morice MC, Krucoff MW
EuroIntervention: 24 Jun 2021; 17:240-247 | PMID: 32830645
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Abstract

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

Gasparini GL, Sanz-Sanchez J, Regazzoli D, Boccuzzi G, ... Belli G, Garbo R
Background
Equipment delivery in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) can be challenging and it is associated with a higher risk of device entrapment. Data regarding the incidence of device entrapment during CTO PCI are lacking.
Aims
The aim of this study was to describe the incidence and procedural characteristics of device entrapment in patients undergoing PCI for CTOs and discuss management strategies for dealing with it.
Methods
Device entrapment was characterised in a large consecutive series of 2,361 CTO PCI cases performed by five high-volume CTO Italian operators between January 2015 and January 2020.
Results
Device entrapment occurred in 36 out of 2,361 cases (1.5%) and consisted of coronary guidewires in 13 (0.5%), microcatheters in 6 (0.2%), balloons in 6 (0.2%), rotational atherectomy burrs in 10 (0.4%) and guiding catheter extension in 1 patient (0.04%). Complete device retrieval was achieved in 63.9%, with at least partial removal of material in 97.2%. Vessel recanalisation was still possible in 86.1% of cases even after device entrapment. Intraprocedural myocardial infarction occurred in 3 patients (8.3%), tamponade with urgent pericardiocentesis in 1 (2.8%) and emergency surgical removal of the entrapped device in 1 patient (2.8%). Mean radiation dose was 4.7±2.3 Gy. At 30-day follow-up, one patient died with stent thrombosis of a non-target vessel and another required repeat percutaneous revascularisation.
Conclusions
Device entrapment during CTO revascularisations is a rare but potentially severe complication. We describe and discuss current techniques of percutaneous retrieval that can be employed to achieve procedural success safely.



EuroIntervention: 24 Jun 2021; 17:212-219
Gasparini GL, Sanz-Sanchez J, Regazzoli D, Boccuzzi G, ... Belli G, Garbo R
EuroIntervention: 24 Jun 2021; 17:212-219 | PMID: 32894229
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Impact:
Abstract

Thin- versus thick-strut polymer-free biolimus-eluting stents: the BioFreedom QCA randomised trial.

Sabaté M, Okkels Jensen L, Tilsted HH, Moreno R, ... Stoll HP, Flensted Lassen J
Background
The BioFreedom drug-coated stent with a stainless steel platform (BF-SS) has been demonstrated to be efficacious in patients at high bleeding risk and receiv-ing only one-month dual antiplatelet therapy.
Aims
The aim of this study was to evaluate the efficacy of the new BioFreedom Ultra drug-coated stent with a thin-strut cobalt-chromium platform (BF-CoCr) compared to the BF-SS in an all-comers population undergoing percutaneous coronary intervention (PCI).
Methods
This was a prospective, multicentre, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) as determined by quantitative coronary angiography at nine-month follow-up. Clinical evaluation was performed at one year.
Results
A total of 200 patients were randomised (1:1) to either the BF-CoCr or the BF-SS stent at eight centres in Spain and Denmark. Baseline clinical and lesion characteristics were similar between the groups. Mean age was 66 years and 23% were female. The mean number of stents implanted per patient was 1.5. At nine-month follow-up, mean in-stent LLL was 0.34±0.49 mm in the BF-CoCr group versus 0.29±0.37 mm in the BF-SS group, p=0.005 for non-inferiority. At one year, target lesion failure was similar between the 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 nine months. Larger studies powered for clinical endpoints are warranted to compare the efficacy of this new platform with currently available DES.



EuroIntervention: 24 Jun 2021; 17:233-239
Sabaté M, Okkels Jensen L, Tilsted HH, Moreno R, ... Stoll HP, Flensted Lassen J
EuroIntervention: 24 Jun 2021; 17:233-239 | PMID: 33433389
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Impact:
Abstract

Completeness of revascularisation in acute coronary syndrome patients with multivessel disease.

Paradies V, Waldeyer C, Laforgia PL, Clemmensen P, Smits PC
A significant proportion of patients presenting with acute coronary syndromes (ACS) have multivessel disease (MVD). Despite the abundance of clinical trials in this area, several questions regarding the procedure of complete coronary revascularisation remain unanswered. This state-of-the-art review summarises the latest evidence on complete revascularisation (CR) in this subset of patients and critically appraises clinical decision making based on non-culprit lesion (NCL) assessment. Future areas of research are put into perspective.



EuroIntervention: 24 Jun 2021; 17:193-201
Paradies V, Waldeyer C, Laforgia PL, Clemmensen P, Smits PC
EuroIntervention: 24 Jun 2021; 17:193-201 | PMID: 34167938
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Impact:
Abstract

Twelve-month Outcomes of the LuX-Valve for Transcatheter Treatment of Severe Tricuspid Regurgitation.

Sun Z, Zhang Z, Li H, Xie Y, ... Li Y, Xie M
Background
Severe functional tricuspid regurgitation is associated with adverse clinical outcomes. Conventional surgical risk for patients with advanced tricuspid regurgitation stage is high, alternative approaches are therefore required.
Aims
The purpose of this study was to investigate the feasibility, technical details, and mid-term outcomes of implantation of a novel radial force-independent orthotopic transcatheter tricuspid valve-LuX-Valve in patients with severe functional tricuspid regurgitation.
Methods
The implantations of LuX-Valve were performed in 6 patients with left-sided valvular surgery and secondary massive tricuspid regurgitation. The anatomy of the tricuspid valve and right heart measurements were evaluated by echocardiography and computed tomography in all patients. Conventional right ventricular (RV) function parameters and RV global longitudinal strain were obtained at baseline and 12-month follow-up, respectively. The LuX-Valve implantation was performed under the guidance of digital subtraction angiography and transesophageal echocardiography.
Results
All patients had successful implantations of LuX-Valves through the right atrium with a substantial reduction in the degree of tricuspid regurgitation. Although one patient with moderate paravalvular leakage died because of right heart failure during three-month follow-up, five patients alive had no significant paravalvular leakage, and displayed significant improvements in mean transvalvular gradient, right heart sizes, conventional RV function indices and RV global longitudinal strain, and a reduction in New York Heart Association functional class during 12-month follow-up.
Conclusions
Transcatheter tricuspid valve replacement with LuX-Valve was feasible and safe for patients with severe functional tricuspid regurgitation. This strategy seems a promising treatment option for patients at high surgical risk.



EuroIntervention: 22 Jun 2021; epub ahead of print
Sun Z, Zhang Z, Li H, Xie Y, ... Li Y, Xie M
EuroIntervention: 22 Jun 2021; epub ahead of print | PMID: 34160351
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Impact:
Abstract

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

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



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

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

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



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

Treatment of acute pulmonary embolism using rheolytic thrombectomy.

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



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

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

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



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

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

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



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

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

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



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

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

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



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

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

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



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

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

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



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

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

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



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

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

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



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

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

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



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

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

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



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

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

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



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

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

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



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

Antithrombotic therapy after percutaneous coronary intervention of bifurcation lesions.

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



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

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

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



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

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

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



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

This program is still in alpha version.