Journal: EuroIntervention

Sorted by: date / impact
Abstract

Clinical outcomes of transcatheter aortic valve implantation in patients younger than 70 years rejected for surgery: the AMTRAC registry.

Witberg G, Landes U, Codner P, Barbanti M, ... Finkelstein A, Kornowski R
Background
The mean age of transcatheter aortic valve implantation (TAVI) patients is steadily decreasing.
Aims
The aim of the study was to describe the characteristics, the indications for and the outcomes of TAVI in patients <70 years old.
Methods
All patients undergoing TAVI (n=8,626) from the 18 participating centres between January 2007 and June 2020 were stratified by age (</> 70). For patients <70, the indications for TAVI were extracted from Heart Team discussions and the baseline characteristics and mortality were compared between the two groups.
Results
Overall, 640 (7.4%) patients were <70 (9.1% during 2018-2020, p<0.001); the mean age was 65.0±2.3 years. The younger patients were more often male, with bicuspid valves or needing valve-in-valve procedures. They had a higher prevalence of lung disease and diabetes. In 80.7% of cases, the Heart Team estimated an increased surgical risk and TAVI was selected, reflected by an STS score >4% in 20.4%. Five-year mortality was similar (29.4 vs 29.8%, HR 0.95, p=0.432) in the <70 and >70 groups. In the <70 group, mortality was higher for those referred for TAVI due to an increased surgical risk compared to those referred for other reasons (31.6 vs 24.5%, HR 1.23, p=0.021). Mortality was similar regardless of the STS stratum in patients judged by the Heart Team to be at increased surgical risk (32.6 vs 30.4%, HR 0.98, p=0.715).
Conclusions
Use of TAVI in patients <70 is becoming more frequent. The main reason for choosing TAVI is due to an increased surgical risk not adequately represented by the STS score. The outcomes for these patients are similar to those for older TAVI patients. Dedicated trials of TAVI/SAVR in younger patients are needed to guide decisions concerning expansion of TAVI indications. (NCT04031274).



EuroIntervention: 21 Oct 2021; epub ahead of print
Witberg G, Landes U, Codner P, Barbanti M, ... Finkelstein A, Kornowski R
EuroIntervention: 21 Oct 2021; epub ahead of print | PMID: 34673502
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Impact:
Abstract

Impact of preprocedural biological markers on 10-year mortality in the SYNTAXES trial.

Hara H, Kawashima H, Ono M, Takahashi K, ... Onuma Y, Serruys PW
Background
Creatinine clearance (CrCl) is an independent determinant of mortality in predictive models of revascularisation outcomes for complex coronary artery disease.
Aims
This study aimed to investigate the impact of preprocedural biological markers on 10-year mortality following coronary revascularisation.
Methods
The SYNTAX Extended Survival (SYNTAXES) study evaluated the 10-year vital status follow-up of 1,800 patients with de novo three-vessel (3VD) and/or left main coronary artery disease (LMCAD) randomised to include percutaneous or surgical coronary revascularisation. The associations between mortality and preprocedural C-reactive protein (CRP), haemoglobin, HbA1c, CrCl, fasting triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol were analysed.
Results
Out of 1,800 patients, 460 patients died before the 10-year follow-up. CRP, HbA1c and CrCl with threshold values of ≥2 mg/L, ≥6% (42 mmol/mol) and <60 ml/min, respectively, were associated with 10-year all-cause death (adjusted hazard ratio [95% confidence interval]: 1.35 [1.01-1.82], 1.51 [1.16-1.95], and 1.46 [1.07-2.00], respectively). There was no significant interaction between the biological markers on all-cause mortality and the type of revascularisation. Preprocedural lipid markers were not significantly associated with 10-year all-cause death, but the non-use of statins was a determinant factor of worse prognosis (adjusted confidence interval [95% confidence interval]: 1.68 [1.26-2.25]).
Conclusions
Preprocedural biomarkers, such as CRP and HbA1c, are associated with long-term mortality post revascularisation, regardless of the revascularisation technique. Conventional lipidic biomarkers associated with high-risk of cardiovascular events seem to be effectively mitigated by the long-term use of statins, whereas the non-use of statins was a factor of a worse prognosis, emphasising the importance of pharmacological treatment.
Trial registration
SYNTAXES ClinicalTrials.gov reference: NCT03417050. SYNTAX ClinicalTrials.gov reference: NCT00114972.



EuroIntervention: 20 Oct 2021; epub ahead of print
Hara H, Kawashima H, Ono M, Takahashi K, ... Onuma Y, Serruys PW
EuroIntervention: 20 Oct 2021; epub ahead of print | PMID: 34669586
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Impact:
Abstract

Incidence and clinical impact of major bleeding following left atrial appendage occlusion: insights from the Amplatzer Amulet Observational Post-Market 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 two-year results of the Amplatzer Amulet Observational Post-Market Study were analysed. 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<0.0001), driven mainly by events occurring beyond the periprocedural period. The annualised rate of ischaemic 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. ClinicalTrials.gov Identifier: NCT02447081. https://clinicaltrials.gov/ct2/show/NCT02447081.



EuroIntervention: 19 Oct 2021; 17:774-782
Aminian A, De Backer O, Nielsen-Kudsk JE, Mazzone P, ... Diener HC, Schmidt B
EuroIntervention: 19 Oct 2021; 17:774-782 | PMID: 33495144
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Abstract

An upfront combined strategy for endovascular haemostasis 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
The aim of this study was 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 haemostasis after transfemoral (TF) TAVI.
Methods
From January 2019 to April 2020, 332 consecutive patients with preprocedural 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 the propensity-score method.
Results
At 30 days, patients receiving SBD+AS had lower rates of major/LT bleeding (1.6% vs 8.9%, odds ratio [OR] 0.17, 95% confidence interval [CI]: 0.04-0.78; p<0.01) and major vascular complications (1.6% vs 8.9%, OR 0.17, 95% CI: 0.04-0.78; p<0.01). In addition, the use of SBD+AS was associated with a significant cost saving related to the vascular event (mean difference -315.3 € per patient, 95% CI: -566.4 € to -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<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 was shown 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. Visual summary. Effectiveness of the upfront combined strategy for endovascular haemostasis in transfemoral transcatheter aortic valve implantation using Angio-Seal on top of a suture-based device (SBD) versus the isolated use of SBD. LT: life-threatening; TF-TAVI: transfemoral transcatheter aortic valve implantation.



EuroIntervention: 19 Oct 2021; 17:728-735
Costa G, Valvo R, Picci A, Criscione E, ... Tamburino C, Barbanti M
EuroIntervention: 19 Oct 2021; 17:728-735 | PMID: 33589411
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Abstract

A deep learning algorithm for detecting acute myocardial infarction.

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



EuroIntervention: 19 Oct 2021; 17:765-773
Liu WC, Lin CS, Tsai CS, Tsao TP, ... Lee CC, Lin C
EuroIntervention: 19 Oct 2021; 17:765-773 | PMID: 33840640
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Impact:
Abstract

Age and functional relevance of coronary stenosis: a post hoc analysis of the ADVISE II trial.

Faria DC, Lee JM, van der Hoef T, Mejía-Rentería H, ... Lerman A, Escaned J
Background
The influence of age-dependent changes on fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) and the response to pharmacological hyperaemia has not been investigated.
Aims
We investigated the impact of age on these indices.
Methods
This is a post hoc analysis of the ADVISE II trial, including a total of 690 pressure recordings (in 591 patients). Age-dependent correlations with FFR and iFR were calculated and adjusted for stenosis severity. Patients were stratified into three age terciles. The hyperaemic response to adenosine, calculated as the difference between resting and hyperaemic pressure ratios, and the prevalence of FFR-iFR discordance were assessed.
Results
Age correlated positively with FFR (r=0.08, 95% CI: 0.01 to 0.15, p=0.015), but not with iFR (r=-0.03, 95% CI: -0.11 to 0.04, p=0.411). The hyperaemic response to adenosine decreased with patient age (0.12±0.07, 0.11±0.06, 0.09±0.05, for the 1st [33-58 years], 2nd [59-69 years] and 3rd [70-94 years] age tertiles, respectively, p<0.001) and showed significant correlation with age (r=-0.14, 95% CI: -0.21 to -0.06, p<0.001). The proportion of patients with FFR ≤0.80+iFR >0.89 discordance doubled in the first age tercile (14.1% vs 7.1% vs 7.0%, p=0.005).
Conclusions
The hyperaemic response of the microcirculation to adenosine administration is age dependent. FFR values increase with patient age, while iFR values remain constant across the age spectrum. These findings contribute to explaining differences observed in functional stenosis classification with hyperaemic and non-hyperaemic coronary indices.



EuroIntervention: 19 Oct 2021; 17:757-764
Faria DC, Lee JM, van der Hoef T, Mejía-Rentería H, ... Lerman A, Escaned J
EuroIntervention: 19 Oct 2021; 17:757-764 | PMID: 33720019
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Impact:
Abstract

Long-term outcomes of catheter-based intervention for clinically significant paravalvular leak.

Perl L, Cohen A, Dadashev A, Shapira Y, ... Kornowski R, Hirsch R
Background
In most centres, clinically significant percutaneous paravalvular leak (PVL) closure following valve replacement surgery is reserved for those considered high-risk for surgery. There is a paucity of data regarding the long-term outcomes of these patients.
Aims
Our goals were to assess the long-term outcomes of patients undergoing percutaneous PVL closure.
Methods
A total of 100 consecutive transcatheter PVL closure procedures (74 mitral, 26 aortic) were performed in 95 patients between February 2005 and August 2019 at our hospital. Data collected included procedural success rates, indication-specific outcomes and mortality.
Results
Mean follow-up was 5.6±6.1 years, mean age 62.6±15.2 years, and 45.4% were female. The device was successfully implanted in 88 procedures (88.0%). Patients who presented with heart failure (n=57) had a significant improvement in NYHA classification (29.2% Class III/IV versus 100.0%, p<0.001). For patients who presented with haemolytic anaemia (n=38), haemoglobin increased (11.94±1.634 vs 9.72±1.49, p<0.001) and LDH levels were reduced (1,354.90±1,225.55 vs 2,039.40±1,347.20, p<0.001) following the procedure. Rates of mortality were 3.8% at 90 days, 15.6% after 1 year, and 27.2% after 5 years.
Conclusions
For patients who are deemed intermediate- to high-risk for repeat surgery, transcatheter PVL closure shows reasonable clinical success rates, with a significant improvement in symptoms, and a relatively low rate of periprocedural complications.



EuroIntervention: 19 Oct 2021; 17:736-743
Perl L, Cohen A, Dadashev A, Shapira Y, ... Kornowski R, Hirsch R
EuroIntervention: 19 Oct 2021; 17:736-743 | PMID: 33720018
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Impact:
Abstract

Proximal optimisation technique versus final kissing balloon inflation in coronary bifurcation lesions: the randomised, multicentre PROPOT trial.

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



EuroIntervention: 19 Oct 2021; 17:747-756
Watanabe Y, Murasato Y, Yamawaki M, Kinoshita Y, ... Suzuki N, Kozuma K
EuroIntervention: 19 Oct 2021; 17:747-756 | PMID: 33775930
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Impact:
Abstract

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

Russo G, Taramasso M, Maisano F
A number of interventional procedures based on the transseptal puncture (TSP) have been developed in recent years. The increasing number of interventional procedures, as well as the use of large-bore sheaths and complex devices, has led to improvements in technique and equipment. The combined use of fluoro-scopy and of transoesophageal echocardiography (TEE) has increased safety and precision. However, TSP still represents a tricky procedure, which may become even more difficult in cases of challenging interatrial septa, and life-threatening complications may occur. Consequently, an in-depth knowledge of procedural steps, equipment, echocardiographic views, fossa ovalis anatomy and how to manage the most frequent complications is critical to performing a successful TSP.



EuroIntervention: 19 Oct 2021; 17:720-727
Russo G, Taramasso M, Maisano F
EuroIntervention: 19 Oct 2021; 17:720-727 | PMID: 33775929
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Impact:
Abstract

Transcatheter aortic valve implantation in degenerated surgical aortic valves.

Tarantini G, Dvir D, Tang GHL
Transcatheter aortic valve implantation (TAVI) within failed bioprosthetic surgical aortic valves (valve-in-valve TAVI) has become an established procedure, currently approved for patients deemed at high risk for repeat aortic valve intervention. Although less invasive than surgical reoperation, challenges of valve-in-valve treatment include higher rates of malposition, prosthesis-patient mismatch and coronary obstruction. Thus, optimal patient selection and preprocedural planning is of the utmost importance to minimise the risk of these complications. In this review article we provide a fully illustrated overview of the most significant periprocedural operative considerations for valve-in-valve TAVI.



EuroIntervention: 19 Oct 2021; 17:709-719
Tarantini G, Dvir D, Tang GHL
EuroIntervention: 19 Oct 2021; 17:709-719 | PMID: 34665140
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Impact:
Abstract

Impact of left ventricular outflow tract calcification in patients undergoing transfemoral transcatheter aortic valve implantation.

Waldschmidt L, Goßling A, Ludwig S, Linder M, ... Conradi L, Schofer N
Background
Left ventricular outflow tract (LVOT) calcification is known to be associated with adverse outcomes after transcatheter aortic valve implantation (TAVI) in patients receiving first-generation transcatheter heart valves (THV).
Aims
The aim of the present study was to assess the prevalence of LVOT calcification as well as its impact on outcomes in a contemporary TAVI patient cohort.
Methods
This retrospective single-centre analysis includes 1,207 patients who underwent transfemoral TAVI between 2012 and 2018 and in whom adequate contrast-enhanced MSCT imaging for quantification of LVOT calcification was available.
Results
Significant LVOT calcification, defined as &gt;10 mm3, was present in 37.4% (n=451) of the patient cohort. After applying propensity score matching there was no difference between patients without (w/o; n=358) and with (w; n=358) significant LVOT calcification with respect to baseline clinical characteristics. At 30 days, the composite of all-cause mortality and non-disabling/disabling stroke occurred more often in patients w LVOT calcification compared to those w/o (4.6 vs 10.1%, p=0.008). Moreover, the composite VARC-3 endpoint of device success at 30 days was in favour of patients w/o LVOT calcification (82.2% vs 73.4%, p=0.007). According to Kaplan-Meier analysis, all-cause mortality one year after TAVI was higher in patients w vs w/o LVOT calcification (12.9 vs 21.4 %, p=0.004).
Conclusions
In patients undergoing TAVI, the presence of significant LVOT calcification is common and associated with worse short-term clinical and functional outcomes as well as higher one-year mortality rates compared to patients w/o LVOT calcification.



EuroIntervention: 18 Oct 2021; epub ahead of print
Waldschmidt L, Goßling A, Ludwig S, Linder M, ... Conradi L, Schofer N
EuroIntervention: 18 Oct 2021; epub ahead of print | PMID: 34658340
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Impact:
Abstract

Linear concentration-response relationship of serum caffeine with adenosine-induced fractional flow reserve overestimation: a comparison with papaverine.

Tanaka H, Matsumoto H, Takahashi H, Hosonuma M, ... Inoue K, Shinke T
Background
Caffeine intake from one cup of coffee one hour before adenosine stress tests, corresponding to serum caffeine levels of 3-4 mg/L, is thought to be acceptable for non-invasive imaging.
Aims
We aimed to elucidate whether serum caffeine is independently associated with adenosine-induced fractional flow reserve (FFR) overestimation and their concentration-response relationship.
Methods
FFR was measured using adenosine (FFRADN) and papaverine (FFRPAP) in 209 patients. FFRADN overestimation was defined as FFRADN - FFRPAP. The locally weighted scatterplot smoothing (LOWESS) approach was applied to evaluate the relationship between serum caffeine level and FFRADN overestimation. Multiple regression analysis was used to determine independent factors associated with FFRADN overestimation.
Results
Caffeine was ingested at &lt;12 hours in 85 patients, at 12-24 hours in 35 patients, and at &gt;24 hours in 89 patients. Multiple regression analysis identified serum caffeine level as the strongest factor associated with FFRADN overestimation (p&lt;0.001). The LOWESS curve demonstrated that FFRADN overestimation started from just above the lower detection limit of serum caffeine and increased approximately 0.01 FFR unit per 1 mg/L increase in serum caffeine level with a linear relationship. The 90th percentile of serum caffeine levels for the ≤12-hour, the 12-24-hour, and the &gt;24-hour groups corresponded to FFRADN overestimations by 0.06, 0.03, and 0.02, respectively.
Conclusions
Serum caffeine overestimates FFRADN values in a linear concentration-response manner. FFRADN overestimation occurs at much lower serum caffeine levels than those that were previously believed. Our results highlight that standardised caffeine control is required for reliable adenosine-induced FFR measurements.



EuroIntervention: 14 Oct 2021; epub ahead of print
Tanaka H, Matsumoto H, Takahashi H, Hosonuma M, ... Inoue K, Shinke T
EuroIntervention: 14 Oct 2021; epub ahead of print | PMID: 34647891
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Impact:
Abstract

Vessel fractional flow reserve (vFFR) for the assessment of stenosis severity: the FAST II study.

Masdjedi K, Tanaka N, Van Belle E, Porouchani S, ... Spitzer E, Daemen J
Background
Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is superior to angiography-guided PCI. The clinical uptake of FFR has been limited, however, by the need to advance a wire in the coronary artery, the additional time required and the need for hyperaemic agents which can cause patient discomfort. FFR derived from routine coronary angiography eliminates these issues.
Aims
The aim of this study was to assess the diagnostic performance and accuracy of three-dimensional quantitative coronary angiography (3D-QCA)-based vessel FFR (vFFR) compared to pressure wire-based FFR (≤0.80).
Methods
The FAST II (Fast Assessment of STenosis severity) study was a prospective observational multicentre study designed to evaluate the diagnostic accuracy of vFFR compared to the reference standard (pressure wire-based FFR ≤0.80). A total of 334 patients from six centres were enrolled. Both site-determined and blinded independent core lab vFFR measurements were compared to FFR.
Results
The core lab vFFR was 0.83±0.09 and pressure wire-based FFR 0.83±0.08. A good correlation was found between core lab vFFR and pressure wire-based FFR (R=0.74; p&lt;0.001; mean bias 0.0029±0.0642). vFFR had an excellent diagnostic accuracy in identifying lesions with an invasive wire-based FFR ≤0.80 (AUC 0.93; 95% CI: 0.90-0.96; p&lt;0.001). Positive predictive value, negative predictive value, diagnostic accuracy, sensitivity and specificity of vFFR were 90%, 90%, 90%, 81% and 95%, respectively.
Conclusions
3D-QCA-based vFFR has excellent diagnostic performance to detect FFR ≤0.80. The study was registered on clinicaltrials.gov under identifier NCT03791320.



EuroIntervention: 13 Oct 2021; epub ahead of print
Masdjedi K, Tanaka N, Van Belle E, Porouchani S, ... Spitzer E, Daemen J
EuroIntervention: 13 Oct 2021; epub ahead of print | PMID: 34647890
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Impact:
Abstract

Angiographic predictors of unplanned rotational atherectomy in complex calcified coronary artery disease: a pooled analysis from the randomised ROTAXUS and PREPARE-CALC trials.

Fitzgerald S, Allali A, Toelg R, Sulimov DS, ... Richardt G, Abdel-Wahab M
Background
Calcified coronary lesions present therapeutic challenges for the interventional cardiologist, often requiring rotational atherectomy (RA).
Aims
This study aimed to develop an angiographic scoring tool to predict the need for a priori RA.
Methods
A pooled analysis of the randomised ROTAXUS and PREPARE-CALC studies was carried out, (N=220 patients, N=313 lesions), by virtue of the fact that both studies made provision for crossover to RA (from balloon dilatation or modified balloon dilatation, respectively). Logistical regression techniques were employed to assess for the presence of patient- or lesion-specific factors leading to a necessity for RA. External validation was performed though retrospective calculation of the score for 192 patients who underwent bail-out RA in a single centre.
Results
Lesion length (odds ratio [OR] 1.02, 95% confidence interval [CI]: 1.00-1.04 per mm, p=0.04), bifurcation lesion (OR 2.60, 95% CI: 1.27-5.30, p=0.009), vessel tortuosity &gt;45° (OR 3.49, 95% CI: 1.73-7.03, p&lt;0.001) and severe vessel calcification (OR 11.60, 95% CI: 3.40-39.64, p&lt;0.001) were predictive of the need for RA in multivariate analysis. Based on the regression coefficients, a scoring system was devised. The greater the score, the more likely a lesion required RA. The scoring system performed well in the external validation cohort, with 78% of patients crossing over having a score of greater than the proposed cut-off of 3.
Conclusions
We provide an angiographic scoring tool to support the expeditious use of time and resources, allowing assessment of the likelihood of success of a balloon-based strategy, or the necessity for RA.



EuroIntervention: 05 Oct 2021; epub ahead of print
Fitzgerald S, Allali A, Toelg R, Sulimov DS, ... Richardt G, Abdel-Wahab M
EuroIntervention: 05 Oct 2021; epub ahead of print | PMID: 34609284
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Impact:
Abstract

Paclitaxel-coated balloons versus percutaneous transluminal angioplasty for infrapopliteal chronic total occlusions: the IN.PACT BTK randomised trial.

Liistro F, Weinberg I, Almonacid Popma A, Shishehbor MH, Deckers S, Micari A
Background
Data are mixed concerning the safety and effectiveness of drug-coated balloons (DCBs) for treating below-the-knee (BTK) lesions.
Aims
The aim of this study was to assess the safety and effectiveness of the IN.PACT 014 paclitaxel-coated balloon catheter versus conventional percutaneous transluminal angioplasty (PTA) for infrapopliteal chronic total occlusions (CTOs) in patients with chronic limb-threatening ischaemia (CLTI).
Methods
The IN.PACT BTK randomised study is a prospective, multicentre, randomised pilot study. Fifty CLTI participants (Rutherford clinical category 4-5) with BTK CTOs were randomised 1:1 to DCB (N=23) or PTA (N=27). The primary effectiveness endpoint was late lumen loss (LLL) at 9 months post procedure. Safety outcomes up to 9 months included all-cause mortality, major target limb amputation, and clinically driven target lesion revascularisation (CD-TLR).
Results
Mean lesion length was 215.41±83.81 mm in the DCB group and 218.19±80.43 mm for PTA (p=0.806). The 9-month angiographic LLL was 0.892±0.774 mm for the DCB group and 1.312±0.720 mm for the PTA group (p=0.070) in a classic analysis, and 0.592±0.944 mm for DCB and 1.260±0.810 mm for PTA (p=0.017) in a subsegmental analysis. The Kaplan-Meier estimated freedom from CD-TLR up to 9 months was 91.1% for DCB and 91.8% for PTA (log-rank p=0.942). At 9 months, 1 patient died in the DCB group and 2 in the PTA group (p=1.000); there were no major target limb amputations in either arm.
Conclusions
The 9-month subsegmental LLL was lower after treatment with the IN.PACT 014 DCB compared with PTA with no differences in safety or revascularisation events in a small complex population of patients with BTK CTOs. ClinicalTrials.gov Identifier: NCT02963649. https://clinicaltrials.gov/ct2/show/NCT02963649.



EuroIntervention: 04 Oct 2021; epub ahead of print
Liistro F, Weinberg I, Almonacid Popma A, Shishehbor MH, Deckers S, Micari A
EuroIntervention: 04 Oct 2021; epub ahead of print | PMID: 34602386
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Impact:
Abstract

Temporal trends in clinical outcomes after percutaneous coronary intervention: a systematic review of 66,327 patients from 25 all-comers trials.

Asano T, Ono M, Dai Z, Saito A, ... Yoneoka D, Komiyama N
Background
With the improvements of percutaneous coronary intervention (PCI) technology and post-PCI patient management, several registry studies reported temporal trends in post-PCI clinical outcomes. However, their results are inconclusive, potentially reflecting region-specific trends, based on site-reported events without external validity.
Aims
This study aimed to investigate temporal trends in post-PCI clinical outcomes in all-comers randomised controlled trials (RCTs) involving coronary stents.
Methods
We performed a systematic review identifying RCTs comparing a clinical outcome as a primary endpoint among different coronary stents with an all-comers design and independent clinical event adjudication, extracting the study start year, patient baseline characteristics, and one- and five-year clinical outcomes. Temporal trends in clinical outcomes (cardiac death, myocardial infarction [MI], target lesion revascularisation [TLR], stent thrombosis [ST]) were assessed using random-effects meta-regression analyses, estimating the relationship between clinical outcomes and study start year.
Results
Overall, 25 all-comers trials (51 device arms, 66,327 patients) conducted between 2003 and 2018 fulfilled the eligibility criteria. Random-effects meta-regression analysis revealed significant decreasing trends in one- and five-year cardiac death, one-year TLR, and five-year ST incidences (relative risk per 10-year increase: 0.69 [0.51-0.92], 0.66 [0.44-0.98], 0.60 [0.41-0.88], and 0.18 [0.07-0.44], respectively). There was no significant trend in myocardial infarction incidences.
Conclusions
This is the first attempt to clarify and quantify the temporal trends of post-PCI outcome incidence. The 15-year improvements in PCI therapy and post-therapeutic patient management are associated with reduced incidences of cardiac death and PCI-related adverse events.



EuroIntervention: 04 Oct 2021; epub ahead of print
Asano T, Ono M, Dai Z, Saito A, ... Yoneoka D, Komiyama N
EuroIntervention: 04 Oct 2021; epub ahead of print | PMID: 34602385
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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
The aim of this study was to detect potential mechanisms of ESR 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 patients (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 to the control group according to propensity score matching with the ESR group.
Results
Although the baseline characteristics of the groups 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 stent placements (68.9% vs 91.1%, p=0.008).
Conclusions
Relief of coronary occlusion induced by a non-ruptured plaque may contribute to ESR in patients with STEMI.



EuroIntervention: 30 Sep 2021; 17:e664-e671
Guo J, Chen J, Wang G, Liu Z, ... Liu B, Li J
EuroIntervention: 30 Sep 2021; 17:e664-e671 | PMID: 33495143
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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 hyperaemia. Continuous intracoronary thermodilution accurately measures coronary flow during hyperaemia.
Aims
The aim of this study was to investigate 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, was recorded using a pressure/temperature guidewire. 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) or 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<0.001).
Conclusions
In addition to hyperaemic 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: 30 Sep 2021; 17:e672-e679
Gallinoro E, Candreva A, Colaiori I, Kodeboina M, ... Collet C, De Bruyne B
EuroIntervention: 30 Sep 2021; 17:e672-e679 | PMID: 33528358
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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 revascularisation (TLR)/reocclusion.
Methods
A total of 1,077 patients with 1,077 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 and those 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 in the remaining 239 (22.2%) cases it was not. 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/reocclusion (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: 30 Sep 2021; 17:e639-e646
Kwon O, Lee PH, Lee SW, Brilakis ES, ... Lee CW, Park SW
EuroIntervention: 30 Sep 2021; 17:e639-e646 | PMID: 33589410
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Impact:
Abstract

Outcomes of retrograde approach for chronic total occlusions by guidewire location.

Fan Y, Maehara A, Yamamoto MH, Hakemi EU, ... Ochiai M, Karmpaliotis D
Background
Connecting the antegrade wire (AW) and the retrograde wire (RW) is a goal of chronic total occlusion (CTO) treatment, but angiographic guidewire location is sometimes misleading.
Aims
The aim of this study was to evaluate the association between intravascular ultrasound (IVUS)-defined AW and RW position and procedural outcomes when treating CTO lesions using the retrograde approach.
Methods
Overall, 191 CTO lesions treated using an IVUS-guided retrograde approach at three centres in Japan, China, and the USA were included.
Results
When the AW and RW angiographically overlapped, four wire positions were seen on 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 intraplaque or subintimal passage. AW-subintima/RW-intraplaque was associated with the most complex CTO morphology and procedure, and repositioning the wire was almost always necessary. Visual summary. When the antegrade wire is in the subintimal space and the retrograde wire is in the intraplaque, re-wiring is almost always necessary.



EuroIntervention: 30 Sep 2021; 17:e647-e655
Fan Y, Maehara A, Yamamoto MH, Hakemi EU, ... Ochiai M, Karmpaliotis D
EuroIntervention: 30 Sep 2021; 17:e647-e655 | PMID: 33589409
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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 recanalisation of coronary chronic total occlusions (CTO) through contemporary dissection and re-entry techniques (DART) as opposed to intraplaque techniques remain controversial.
Aims
The aim of this study was to compare clinical and angiographic outcomes following subintimal and intraplaque CTO recanalisation.
Methods
A total of 454 consecutive patients undergoing successful CTO recanalisation (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
There were no significant differences in terms of the cumulative incidence of MACE (p=0.908) or binary restenosis (p=0.320) between the two groups. There was no independent correlation between recanalisation technique and MACE occurrence or in-segment binary restenosis. Target lesion revascularisation (TLR) was performed in 60 (17.5%) and 12 (18.1%) (p=0.719) 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 midterm clinical and angiographic outcomes compared to intraplaque recanalisation. The rate of occlusive restenosis was low and comparable in both groups. Regardless of recanalisation technique, the overall incidences of binary restenosis and TLR following CTO recanalisation remain higher than those reported for non-CTO PCI.



EuroIntervention: 30 Sep 2021; 17:e656-e663
Xhepa E, Cassese S, Ndrepepa G, Joner M, ... Kastrati A, Fusaro M
EuroIntervention: 30 Sep 2021; 17:e656-e663 | PMID: 33646124
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Impact:
Abstract

Occlusion patterns, strategies and procedural outcomes of percutaneous coronary intervention for in-stent chronic total occlusion.

Sekiguchi M, Muramatsu T, Kishi K, Sumitsuji S, ... Tanaka H, Tsuchikane E
Background
In-stent chronic total occlusion (CTO) presents various occlusion patterns, which complicate percutaneous coronary intervention (PCI).
Aims
The aim of the study was to investigate the initial outcome and strategy of PCI for in-stent CTO according to the angiographic occlusion patterns.
Methods
This study assessed 791 in-stent CTOs from the Japanese CTO-PCI Expert Registry from 2015 to 2018. They were divided into four patterns: pattern A (n=419), CTO within the stent segment; pattern B (n=196), CTO beyond the distal edge; pattern C (n=85), CTO beyond the proximal edge; and pattern D (n=69) CTO beyond both the proximal and distal edges.
Results
There were significant differences in the technical success rates (96.2%, 86.2%, 92.9%, and 75.4% for patterns A-D, respectively; p<0.001), guidewire crossing times (22 [interquartile range: 10-46], 52 [24-102], 40 [20-78], and 86 [45-127] min, respectively; p<0.001), and the rates of antegrade approach alone (90.9%, 61.2%, 67.1%, and 31.9%, respectively; p<0.001).
Conclusions
PCI for CTO within the stent segment was associated with excellent initial outcomes with the antegrade approach. However, PCI for CTO beyond both the proximal and distal edges was associated with the poorest outcomes, even with the bidirectional approach.



EuroIntervention: 30 Sep 2021; 17:e631-e638
Sekiguchi M, Muramatsu T, Kishi K, Sumitsuji S, ... Tanaka H, Tsuchikane E
EuroIntervention: 30 Sep 2021; 17:e631-e638 | PMID: 33720017
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Impact:
Abstract

Intravascular imaging and histological correlates of medial and intimal calcification in peripheral artery disease.

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



EuroIntervention: 30 Sep 2021; 17:e688-e698
Jinnouchi H, Sato Y, Bhoite RR, Kuntz SH, ... Virmani R, Finn AV
EuroIntervention: 30 Sep 2021; 17:e688-e698 | PMID: 33896763
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Impact:
Abstract

Balloon aortic valvuloplasty for severe aortic stenosis before urgent non-cardiac surgery.

Debry N, Altes A, Vincent F, Delhaye C, ... Maréchaux 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 non-cardiac surgery (NCS). Whether this strategy is better than medical therapy in this very specific population is unknown.
Aims
We aimed to evaluate 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 two centres included 133 patients with SAS undergoing urgent NCS, of whom 93 underwent preoperative BAV (IS) and 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).
Results
The primary outcome was MACE at one-month follow-up after NCS including mortality, heart failure, and other cardiovascular outcomes. 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, the 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) had events 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 three-month survival (89.2% vs 90.0%; IPTW-adjusted HR 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: 30 Sep 2021; 17:e680-e687
Debry N, Altes A, Vincent F, Delhaye C, ... Maréchaux S, Van Belle E
EuroIntervention: 30 Sep 2021; 17:e680-e687 | PMID: 34105511
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Impact:
Abstract

Glucose-lowering therapy in patients undergoing percutaneous coronary intervention.

Johansson I, Dicembrini I, Mannucci E, Cosentino F
The number of individuals with diabetes and pre-diabetes is constantly increasing. These conditions are overrepresented in patients undergoing percutaneous coronary intervention and are associated with adverse prognosis. Optimal glycaemic control during an acute coronary syndrome is a relevant factor for the improvement of longer-term outcomes. In addition, the implementation of newer glucose-lowering drugs with proven cardiovascular benefits has a remarkable impact on recurrence of events, hospitalisations for heart failure and mortality. In this narrative review, we outline the current state-of-the art recommendations for glucose-lowering therapy in patients with diabetes undergoing coronary intervention. In addition, we discuss the most recent evidence-based indications for revascularisation in patients with diabetes as well as the targets for glycaemic control post revascularisation. Current treatment goals for concomitant risk factor control are also addressed. Lastly, we acknowledge the presence of knowledge gaps in need of future research.



EuroIntervention: 30 Sep 2021; 17:e618-e630
Johansson I, Dicembrini I, Mannucci E, Cosentino F
EuroIntervention: 30 Sep 2021; 17:e618-e630 | PMID: 34596567
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Impact:
Abstract

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

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



EuroIntervention: 19 Sep 2021; 17:576-583
Westra J, Li Z, Rasmussen LD, Winther S, ... Bøttcher M, Tu S
EuroIntervention: 19 Sep 2021; 17:576-583 | PMID: 33196446
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Impact:
Abstract

Near-infrared spectroscopy carotid plaque characteristics and cerebral embolism in carotid artery stenting.

Nakagawa I, Kotsugi M, Park HS, Furuta T, ... Motoyama Y, Nakase H
Background
Perioperative thromboembolism is the main consideration in carotid artery stenting (CAS). Precise evaluation of carotid plaque components is clinically important to reduce ischaemic complications since CAS mechanically pushes plaque outwards, which releases plaque debris into the bloodstream.
Aims
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
Carotid stenosis magnetic resonance (MR) T1-weighted plaque signal intensity ratio (T1W-SIR) followed by NIRS assessment at the time of CAS (using the carotid artery Wallstent) was performed in 117 consecutive patients.
Results
The maximum lipid core burden index (max-LCBI) at minimal luminal areas (MLA; max-LCBIMLA) and the max-LCBI for any 4 mm segment in a target lesion defined as max-LCBIarea were significantly higher for the post-procedural new ipsilateral diffusion-weighted magnetic resonance imaging (DWI)-positive than negative patients (p<0.001 for all). There was a significant linear correlation between max-LCBIarea and the number of new emboli (r=0.544, p<0.0001). We also found that the second quantile (Q2) of T1W-SIRMLA had a significantly higher max-LCBIMLA and a higher incidence of DWI positivity than Q1 and Q3 (p<0.001 for all). Furthermore, max-LCBIMLA appeared to distinguish between patients with and without postoperative new ipsilateral DWI positivity (AUC 0.91, 95% CI: 0.86-0.96; p<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: 19 Sep 2021; 17:599-606
Nakagawa I, Kotsugi M, Park HS, Furuta T, ... Motoyama Y, Nakase H
EuroIntervention: 19 Sep 2021; 17:599-606 | PMID: 33283761
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Impact:
Abstract

Coronary sinus narrowing for the treatment of refractory angina: a multicentre prospective open-label clinical study (the REDUCER-I study).

Verheye S, Agostoni P, Giannini F, Hill JM, ... Banai S, Konigstein M
Background
The REDUCER-I study is a prospective (with a retrospective component), open-label, multi-centre, international, post-market study, which collects long-term data of patients with refractory angina treated with the Reducer. Here we present the overall clinical outcomes of the first 228 patients enrolled.
Aims
The aim of this study is 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
REDUCER-I is a multicentre, non-randomised observational study. Enrolled patients had refractory angina pectoris Canadian Cardiovascular Society (CCS) class II-IV and were treated with Reducer implantation.
Results
In the first 228 patients (81% male, 68.3±9.6 years), the 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 two years. Improvement in ≥1 CCS class was observed in 82%, and in ≥2 CCS classes in 31% of patients at two years. At baseline, 70% of the cohort were reported to be in CCS class III-IV; this portion was reduced to 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 up to two years.



EuroIntervention: 19 Sep 2021; 17:561-568
Verheye S, Agostoni P, Giannini F, Hill JM, ... Banai S, Konigstein M
EuroIntervention: 19 Sep 2021; 17:561-568 | PMID: 33319762
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Impact:
Abstract

Long-term safety of drug-coated devices for peripheral revascularisation.

Secemsky EA, Barrette E, Bockstedt L, Bonaca MP, ... Manda B, Yeh RW
Background
Meta-analyses of randomised trials of paclitaxel-coated peripheral devices found an association with worse long-term survival.
Aims
We aimed to assess long-term mortality in patients treated with drug-coated versus non-drug-coated devices who are insured by Medicare Advantage (MA), an alternative to traditional Medicare that represents >30% of the Medicare eligible population. We analysed data from an MA administrative claims data source that includes both inpatient and outpatient femoropopliteal artery revascularisation procedures.
Methods
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 up to 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.
Results
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 to non-drug-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>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: 19 Sep 2021; 17:590-598
Secemsky EA, Barrette E, Bockstedt L, Bonaca MP, ... Manda B, Yeh RW
EuroIntervention: 19 Sep 2021; 17:590-598 | PMID: 33342764
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Impact:
Abstract

Prognostic impact and clinical outcomes of coronary flow reserve and hyperaemic microvascular resistance.

Toya T, Corban MT, Park JY, Ahmad A, ... Lerman LO, Lerman A
Background
Most studies dichotomise indices of coronary microvascular function to assess their prognostic values.
Aims
We aimed to investigate whether coronary flow reserve (CFR) and hyperaemic microvascular resistance (HMR) as continua predict major adverse cardiovascular events (MACE), comprising all-cause death, myocardial infarction, revascularisation, and stroke in patients with ischaemia and non-obstructive coronary artery disease.
Methods
A total of 610 patients were included and followed up over a median of 8.0 years (199 individual MACE in 174 patients).
Results
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 mmHg/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 mmHg/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: 19 Sep 2021; 17:569-575
Toya T, Corban MT, Park JY, Ahmad A, ... Lerman LO, Lerman A
EuroIntervention: 19 Sep 2021; 17:569-575 | PMID: 33342762
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Impact:
Abstract

Mortality after bleeding versus myocardial infarction in coronary artery disease: a systematic review and meta-analysis.

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



EuroIntervention: 19 Sep 2021; 17:550-560
Piccolo R, Oliva A, Avvedimento M, Franzone A, ... Esposito G, Jüni P
EuroIntervention: 19 Sep 2021; 17:550-560 | PMID: 33840639
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Impact:
Abstract

Robotics, imaging, and artificial intelligence in the catheterisation laboratory.

Beyar R, Davies JE, Cook C, Dudek D, Cummins PA, Bruining N
The catheterisation laboratory today combines diagnosis and therapeutics, through various imaging modalities and a prolific list of interventional tools, led by balloons and stents. In this review, we focus primarily on advances in image-based coronary interventions. The X-ray images that are the primary modality for diagnosis and interventions are combined with novel tools for visualisation and display, including multi-imaging co-registration modalities with three- and four-dimensional presentations. Interpretation of the physiologic significance of coronary stenosis based on prior angiographic images is being explored and implemented. Major efforts to reduce X-ray exposure to the staff and the patients, using computer-based algorithms for image processing, and novel methods to limit the radiation spread are being explored. The use of artificial intelligence (AI) and machine learning for better patient care requires attention to universal methods for sharing and combining large data sets and for allowing interpretation and analysis of large cohorts of patients. Barriers to data sharing using integrated and universal protocols should be overcome to allow these methods to become widely applicable. Robotic catheterisation takes the physician away from the ionising radiation spot, enables coronary angioplasty and stenting without compromising safety, and may allow increased precision. Remote coronary procedures over the internet, that have been explored in virtual and animal studies and already applied to patients in a small pilot study, open possibilities for sharing experience across the world without travelling. Application of those technologies to neurovascular, and particularly stroke interventions, may be very timely in view of the need for expert neuro-interventionalists located mostly in central areas.



EuroIntervention: 19 Sep 2021; 17:537-549
Beyar R, Davies JE, Cook C, Dudek D, Cummins PA, Bruining N
EuroIntervention: 19 Sep 2021; 17:537-549 | PMID: 34554096
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Impact:
Abstract

Valve-in-valve transcatheter aortic valve implantation versus repeat surgical aortic valve replacement in patients with a failed aortic bioprosthesis.

Majmundar M, Doshi R, Kumar A, Johnston D, ... Kapadia SR, Kalra A
Background
Limited data are available regarding clinical outcomes of valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) following the United States Food and Drug Administration approval of ViV TAVI in 2015.
Aims
The aim of this study was to evaluate in-hospital, 30-day, and 6-month outcomes of ViV TAVI versus repeat surgical aortic valve replacement (SAVR) in patients with a failed aortic bioprosthetic valve.
Methods
This retrospective cohort study identified patients who underwent ViV TAVI or repeat SAVR utilising the Nationwide Readmission Database from 2016 to 2018. Primary outcomes were all-cause readmission (at 30 days and 6 months) and in-hospital death. Secondary outcomes were in-hospital stroke, pacemaker implantation, 30-day/6-month major adverse cardiac events (MACE), and mortality during readmission. Propensity score-matching (inverse probability of treatment weighting) analyses were implemented.
Results
Out of 6,769 procedures performed, 3,724 (55%) patients underwent ViV TAVI, and 3,045 (45%) underwent repeat SAVR. ViV TAVI was associated with lower in-hospital all-cause mortality (odds ratio [OR] 0.42, 95% confidence interval [CI]: 0.20-0.90, p=0.026) and a higher rate of 30-day (hazard ratio [HR] 1.46, 95% CI: 1.13-1.90, p=0.004) and 6-month all-cause readmission (HR 1.54, 95% CI: 1.14-2.10, p=0.006) compared with repeat SAVR. All secondary outcomes were comparable between the two groups.
Conclusions
ViV TAVI was associated with lower in-hospital mortality but higher 30-day and 6-month all-cause readmission. However, there was no difference in risk of in-hospital stroke, post-procedure pacemaker implantation, MACE, and mortality during 30-day and 6-month readmission compared with repeat SAVR, suggesting that ViV TAVI can be performed safely in carefully selected patients.



EuroIntervention: 14 Sep 2021; epub ahead of print
Majmundar M, Doshi R, Kumar A, Johnston D, ... Kapadia SR, Kalra A
EuroIntervention: 14 Sep 2021; epub ahead of print | PMID: 34521614
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Impact:
Abstract

Mechanical thrombectomy with retrievable stents and aspiration catheters for acute ischaemic stroke: a meta-analysis of randomised controlled trials.

Rajkumar CA, Ganesananthan S, Ahmad Y, Seligman H, ... Malik IS, Shun-Shin MJ
Background
Retrievable stents and aspiration catheters have been developed to provide more effective arterial recanalisation in acute ischaemic stroke.
Aims
The aim of this analysis was to test the effect of mechanical thrombectomy on mortality and long-term neurological outcome in patients presenting with acute large-vessel anterior circulation ischaemic stroke.
Methods
A structured search identified randomised controlled trials of thrombectomy (using a retrievable stent or aspiration catheter) versus control on a background of medical therapy which included intravenous thrombolysis if appropriate. The primary endpoint was disability at 90-day follow-up as assessed by the modified Rankin scale (mRS). Secondary endpoints included all-cause mortality and symptomatic intracranial haemorrhage. A Bayesian mixed-effects model was used for analysis.
Results
Twelve (12) trials met the inclusion criteria, comprising a total of 1,276 patients randomised to thrombectomy and 1,282 patients to control. Randomisation to thrombectomy significantly reduced disability at 90 days (OR 0.52, 95% credible interval 0.46 to 0.61, probability(control better)&lt;0.0001). Furthermore, thrombectomy reduced the odds of functional dependence at 90 days, indicated by an mRS score &gt;2 (OR 0.44, CrI 0.37 to 0.52, pr&lt;0.0001). Thrombectomy reduced all-cause mortality at 90 days (16.1% vs 19.2%, OR 0.81, 95% CrI 0.66 to 0.99, pr=0.024). The frequency of symptomatic intracranial haemorrhage was similar between thrombectomy (4.2%) and control (4.0%) (OR 1.12, 95% CrI 0.76 to 1.68, pr=0.72).
Conclusions
In patients with an acute anterior circulation stroke, modern device thrombectomy significantly reduces death and subsequent disability. The magnitude of these effects suggests that universal access to this treatment strategy should be the standard of care.



EuroIntervention: 09 Sep 2021; epub ahead of print
Rajkumar CA, Ganesananthan S, Ahmad Y, Seligman H, ... Malik IS, Shun-Shin MJ
EuroIntervention: 09 Sep 2021; epub ahead of print | PMID: 34503942
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Impact:
Abstract

Paravalvular Regurgitation Post-Transcatheter Aortic Valve Replacement in Intermediate Risk Patients: A Pooled PARTNER 2 Study.

Chau KH, Chen S, Crowley A, Redfors B, ... Pibarot P, Leon MB
Background
Moderate or worse paravalvular regurgitation (PVR) post-transcatheter aortic valve replacement (TAVR) is associated with increased mortality. The mechanisms by which this occurs are not fully understood.
Aims
To determine the mechanism by which PVR leads to worse outcomes.
Methods
1,974 intermediate-risk patients who received TAVR in the PARTNER 2 trial and registries were grouped by PVR severity. Clinical and echocardiographic outcomes were compared.
Results
1,176 (60%) patients had none/trace, 680 (34%) had mild, and 118 (6%) had ≥moderate PVR. At 2 years, ≥moderate PVR patients had increased risks of all-cause (HR 2.33 [1.41-3.85], P-value=0.001) and cardiovascular death (HR 3.30 [1.74-6.28], P-value&lt;0.001), re-hospitalization (HR 2.68 [1.57-4.58], P-value&lt;0.001), and re-intervention (HR 14.72 [3.13-69.32], P-value&lt;0.001). ≥Moderate PVR was associated with greater increases in left ventricular (LV) end diastolic and systolic dimensions and volumes, LV mass indices, and reductions in LV ejection fractions (LVEFs) from 30 days to 2 years. Mild PVR was not associated with worse outcomes. Adjusting for LV dimensions and LVEF from the 1-year echocardiogram, patients with ≥moderate PVR still had an increased risk of all-cause death or re-hospitalization at 2 years (HR 2.84 [1.25-5.78], P-value=0.009).
Conclusions
≥Moderate PVR, but not mild PVR, is associated with an increased risk of all-cause and cardiovascular death, re-hospitalization, and re-intervention at 2 years. ≥Moderate PVR is also associated with adverse LV remodeling, which partially mediates how ³moderate PVR leads to worse outcomes. These results provide dual insights on the deleterious impact of ≥moderate PVR and the contributing mechanisms of poor clinical outcomes.



EuroIntervention: 30 Aug 2021; epub ahead of print
Chau KH, Chen S, Crowley A, Redfors B, ... Pibarot P, Leon MB
EuroIntervention: 30 Aug 2021; epub ahead of print | PMID: 34483095
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Impact:
Abstract

Long-Term Clinical Outcomes of Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Stents: Final 5-Year Results of the AIDA Randomized Clinical Trial.

Kerkmeijer LSM, Renkens MPL, Tijssen RYG, Hofma SH, ... de Winter RJ, Wykrzykowska JJ
Background
Absorb bioresorbable vascular scaffold (BVS) related events have been reported between 1 and 3 years - the period of active scaffold bioresorption. Data on the performance of Absorb BVS in daily clinical practice beyond this time point is scarce.
Aims
This report provides the final five-year clinical follow-up of the Absorb BVS in comparison with Xience everolimus-eluting stent (EES). In addition, we evaluated the effect of prolonged dual-antiplatelet therapy (DAPT) administration on events in the scaffold group.
Methods
AIDA was a multicentre, investigator-initiated, non-inferiority trial, in which 1,845 unselected patients with coronary artery disease were randomly assigned to either Absorb BVS (n=924) or Xience EES (n=921). Target vessel failure (TVF), composite of cardiac death, target vessel myocardial infarction or target vessel revascularisation, was the primary endpoint. Scaffold thrombosis cases were matched with controls and tested for effect of prolonged DAPT.
Results
Through 5 years follow-up, there was no difference in TVF between Absorb BVS (17.7%) and Xience EES (16.1%) (hazard ratio 1.31, 95% CI 0.90-1.41, p=0.302). Definite or probable device thrombosis (DT) occurred in 43 patients (4.8%) of the scaffold group compared to 13 patients (1.5%) of the stent group (hazard ratio 3.32; 95% CI 1.78-6.17; p&lt;0.001). DT between 3- and 4-years occurred six times in Absorb-arm versus three in Xience-arm. Between 4- and 5-years the incidence was 3 versus 2, respectively. Of those three DT in scaffold group, two occurred in Xience EES treated lesions. The odds ratio of scaffold thrombosis in patients on DAPT compared to off DAPT throughout 5-year follow-up was 0.36 (95% CI 0.15-0.86).
Conclusions
The excess risk of Absorb BVS on late adverse events, in particular device thrombosis, in routine PCI continues up to 4-years and seems to plateau afterwards.



EuroIntervention: 30 Aug 2021; epub ahead of print
Kerkmeijer LSM, Renkens MPL, Tijssen RYG, Hofma SH, ... de Winter RJ, Wykrzykowska JJ
EuroIntervention: 30 Aug 2021; epub ahead of print | PMID: 34483094
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Impact:
Abstract

Computed Tomography-Based Selection of Transseptal Puncture Site for Percutaneous Left Atrial Appendage Closure.

Fukutomi M, Fuchs A, Bieliauskas G, Wong I, ... Søndergaard L, De Backer O
Background
An inferoposterior transseptal puncture (TSP) is generally recommended for percutaneous left atrial appendage (LAA) closure. However, the LAA is a highly variable anatomical structure; this may impact the preferred TSP site.
Aims
This study aimed to determine the most optimal TSP site for percutaneous LAA closure in different LAA morphologies.
Methods
In this prospective study, 182 patients undergoing percutaneous LAA closure were included. The spatial relationship of the LAA to the fossa ovalis and its consequence for TSP was assessed at pre-procedural cardiac computed tomography (CCT).
Results
Based on CCT analysis, it was predicted that co-axial alignment between delivery sheath and LAA would be obtained by an inferoposterior, -central, or -anterior TSP in 75%, 16% and 8% of cases, respectively. This was also confirmed by procedural LAA angiogram in 175 cases (96%) with &lt;30o angle between delivery sheath and LAA central axis. Multivariate logistic regression analysis identified reverse chicken wing LAA (Odds Ratio (OR) 6.36 [1.85-29.3]; P=0.005) and posterior bending of the proximal LAA (OR 17.2 [3.3-96.2]; P&lt;0.001) as independent predictors of a central or anterior TSP - this to increase the chance of obtaining co-axial alignment between delivery sheath and LAA.
Conclusions
An inferoposterior TSP is recommended in a majority of percutaneous LAA closure procedures in order to obtain co-axial alignment between delivery sheath and LAA. An inferior but more central/anterior TSP should be recommended in case of a reverse chicken wing LAA or posterior bending of the proximal LAA, which occurs in 20-25% of cases.



EuroIntervention: 30 Aug 2021; epub ahead of print
Fukutomi M, Fuchs A, Bieliauskas G, Wong I, ... Søndergaard L, De Backer O
EuroIntervention: 30 Aug 2021; epub ahead of print | PMID: 34483092
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Impact:
Abstract

Percutaneous edge-to-edge mitral repair in the presence of mitral annulus calcification.

Fernández-Peregrina E, Pascual I, Freixa X, Tirado-Conte G, ... Nombela-Franco L, Arzamendi D
Background
MAC is commonly found in patients affected with MR and it\'s associated with high morbidity, mortality and worse cardiac surgical outcomes. Transcatheter edge-to-edge repair could be an alternative treatment although with little evidence in this population.
Aims
To analyze the safety, efficacy and durability of MitraClip in patients affected with mitral regurgitation (MR) and mitral annulus calcification (MAC).
Methods
We analyzed outcomes of 61 suitable patients affected with severe MR and moderate-or-severe MAC (\"MAC\" group) and 791 patients with no-or-mild MAC (\"NoMAC\" group) treated with MitraClip.
Results
Procedural success was similar (91,8% vs 95,1%, p=0,268, in MAC and NoMAC respectively) with a very low rate of complications. At one-year follow-up, 90,6% of MAC and 79,5% of NoMAC patients had MR grade ≤2 (p =0,129), 80% in both groups remained in NYHA functionalclass ≤II and a significant reduction in cardiac readmissions was observed (65% vs 78% in MAC vs NoMAC, p=0,145). One-year mortality tended to be higher in MAC patients (19,7% vs 11,3%, p=0,050) with no difference in cardiovascular mortality (15,3% vs 9,2%, p=0,129).
Conclusions
MitraClip in selected patients with moderate-or-severe MAC is safe, feasible and achieves good clinical and echocardiographic results at one-year follow-up.



EuroIntervention: 30 Aug 2021; epub ahead of print
Fernández-Peregrina E, Pascual I, Freixa X, Tirado-Conte G, ... Nombela-Franco L, Arzamendi D
EuroIntervention: 30 Aug 2021; epub ahead of print | PMID: 34483091
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Impact:
Abstract

Prevalence, predictors, and outcomes of in-stent restenosis with calcified nodules.

Tada T, Miura K, Ohya M, Shimada T, ... Fuku Y, Kadota K
Background
Calcified nodules (CN) has been reported to be associated with stent failure including in-stent restenosis (ISR). However, there is no systematic study of this condition.
Aims
We aimed to clarify the prevalence, predictors, and midterm results of ISR lesions with CN.
Methods
We examined the clinical characteristics of 651 ISR lesions which underwent percutaneous coronary intervention (PCI) with optical coherence tomography between October 2008 and July 2016, and their 6- to 8-month follow-up angiography results. CN was defined as a high backscattering mass with small nodular calcium depositions which protruded in the vessel lumen.
Results
Thirty-two ISR lesions (4.9%) had CN. Multivariable analysis showed that calcified lesion (odds ratio [OR] 12.441, P &lt; 0.001), incomplete stent apposition (OR 3.228, P = 0.005), hemodialysis (OR 3.633, P = 0.024), and female gender (OR 3.212, P = 0.036) were independently associated with ISR lesions with CN. Midterm follow-up was performed on 612 ISR lesions. Both ISR and target lesion revascularization (TLR) rates were significantly higher in lesions with CN compared with those without CN (43.8% vs. 25.0%, P = 0.023; 37.5% vs. 18.8%, P = 0.020, respectively). However, multivariate analysis did not show the presence of CN as an independent predictor for re-TLR (OR 1.690, P = 0.286).
Conclusions
The prevalence of ISR lesions with CN was 4.9%. Calcified lesion, incomplete stent apposition, hemodialysis, and the female gender are likely associated with CN formation. ISR lesions with CN may have poor midterm outcomes compared with ISR lesions without CN.



EuroIntervention: 30 Aug 2021; epub ahead of print
Tada T, Miura K, Ohya M, Shimada T, ... Fuku Y, Kadota K
EuroIntervention: 30 Aug 2021; epub ahead of print | PMID: 34483090
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Impact:
Abstract

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

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



EuroIntervention: 26 Aug 2021; 17:489-496
Nakamura D, Dohi T, Ishihara T, Kikuchi A, ... Nishino M, Sakata Y
EuroIntervention: 26 Aug 2021; 17:489-496 | PMID: 32985411
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Impact:
Abstract

Dual antithrombotic therapy with dabigatran in patients with atrial fibrillation after percutaneous coronary intervention for ST-segment elevation myocardial infarction: a post hoc analysis of the randomised RE-DUAL PCI trial.

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



EuroIntervention: 26 Aug 2021; 17:474-480
Zeymer U, Leiva O, Hohnloser SH, Steg PG, ... Bhatt DL, Cannon CP
EuroIntervention: 26 Aug 2021; 17:474-480 | PMID: 33164896
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Impact:
Abstract

Predictors of non-stenting strategy for acute coronary syndrome caused by plaque erosion: four-year outcomes of the EROSION study.

He L, Qin Y, Xu Y, Hu S, ... Mintz GS, Yu B
Background
The EROSION study demonstrated that patients with an acute coronary syndrome (ACS) caused by plaque erosion could be treated with antithrombotic therapy without stenting. However, the long-term prognosis of this strategy is still unclear.
Aims
The aim of this study was to test whether a non-stenting antithrombotic strategy was still effective at four-year follow-up and to explore potential predictors of long-term prognosis.
Methods
This study was a long-term follow-up of the EROSION study. Follow-up was conducted by phone call or clinical visit. Patients were divided into two groups - those with target lesion revascularisation (the TLR group), and the non-TLR group.
Results
Out of 55 patients who completed one-month follow-up, 52 patients finished four-year follow-up. The median duration was 4.8 years (range, 4.2-5.8 years). The majority of patients remained free from events, and all patients were free from hard endpoints (death, myocardial infarction, stroke, bypass surgery, or heart failure). Only one patient had gastrointestinal bleeding, and 11 patients underwent TLR. Patients in the non-TLR group had more optical coherence tomography (OCT) thrombus reduction from baseline to one month; 95% of patients in the non-TLR group versus 45% in the TLR group (p=0.001) met the primary endpoint (thrombus volume reduction >50%). Angiographic results showed that the TLR group had less improvement in diameter stenosis (p=0.014) at one month compared with the non-TLR group.
Conclusions
Four-year follow-up findings reconfirmed the safety of an antithrombotic therapy without stenting for ACS caused by erosion. Patients with better response to antithrombotic therapy in the first month were less likely to require stent implantation during the next four years.



EuroIntervention: 26 Aug 2021; 17:497-505
He L, Qin Y, Xu Y, Hu S, ... Mintz GS, Yu B
EuroIntervention: 26 Aug 2021; 17:497-505 | PMID: 33164894
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Impact:
Abstract

Super high-pressure balloon versus scoring balloon to prepare severely calcified coronary lesions: the ISAR-CALC randomised trial.

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



EuroIntervention: 26 Aug 2021; 17:481-488
Rheude T, Rai H, Richardt G, Allali A, ... Byrne RA, Cassese S
EuroIntervention: 26 Aug 2021; 17:481-488 | PMID: 33258774
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Impact:
Abstract

National French registry of spontaneous coronary artery dissections: prevalence of fibromuscular dysplasia and genetic analyses.

Combaret N, Gerbaud E, Dérimay F, Souteyrand G, ... Bouatia-Naji N, Motreff P
Background
Spontaneous coronary artery dissection (SCAD) is an increasingly reported but poorly understood condition. Few European data are available.
Aims
The aims of this study were to obtain European data on SCAD, determine the prevalence of fibromuscular dysplasia (FMD) and enable genetic analyses in this population.
Methods
Data from a national French registry of SCAD cases were analysed prospectively and retrospectively. Clinical and angiographic data and management strategy were collected. Major adverse cardiovascular events (MACE) were analysed after one year of follow-up. Subjects were screened for FMD and blood was collected for DNA extraction.
Results
From June 2016 to August 2018, 373 SCAD cases were confirmed by the core lab. Mean age was 51.5 years. Patients were mostly women (90.6%) and 54.7% of cases had less than two cardiovascular risk factors. At one year, 295 patients (79.1%) were treated conservatively, the MACE rate was 12.3%, and there were no cases of mortality. The recurrence rate of SCAD was 3.3%. FMD was found at ≥1 arterial site in 45.0% of cases. We also confirmed the genetic association between the PHACTR1 locus and SCAD (odds ratio=1.66, p=7.08×10-8).
Conclusions
Here we describe the DISCO registry, the largest European SCAD cohort where FMD was found in 45% of cases and the genetic association with PHACTR1 was confirmed. This nationwide cohort is a valuable resource for future clinical and genetic investigation to understand SCAD aetiology.



EuroIntervention: 26 Aug 2021; 17:508-515
Combaret N, Gerbaud E, Dérimay F, Souteyrand G, ... Bouatia-Naji N, Motreff P
EuroIntervention: 26 Aug 2021; 17:508-515 | PMID: 33319763
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Impact:
Abstract

Clinical outcomes by angiographic type of spontaneous coronary artery dissection.

Mori R, Macaya F, Giacobbe F, Salinas P, ... Cerrato E, Escaned J
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
The aim of this study was 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 centres across Italy and Spain. Cases were classified into five 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 haematoma (2A and 3): 20.0% vs 5.4%, p<0.001 (non-fatal MI: 11.0% vs 3.5%, p=0.009; unplanned revascularisation: 11.0% vs 2.5%, p<0.001). This 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 haematoma (angiotypes 2A and 3) showed an increased risk of short-term adverse clinical events that was maintained during follow-up.



EuroIntervention: 26 Aug 2021; 17:516-524
Mori R, Macaya F, Giacobbe F, Salinas P, ... Cerrato E, Escaned J
EuroIntervention: 26 Aug 2021; 17:516-524 | PMID: 33650491
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Impact:
Abstract

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

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



EuroIntervention: 26 Aug 2021; 17:466-473
Noc M, Laanmets P, Neskovic AN, Petrović M, ... Erlinge D, Keeble TR
EuroIntervention: 26 Aug 2021; 17:466-473 | PMID: 34031023
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Impact:
Abstract

Management of cardiogenic shock.

Thiele H, de Waha-Thiele S, Freund A, Zeymer U, Desch S, Fitzgerald S
Despite the rapidly evolving evidence base in modern cardiology, progress in the area of cardiogenic shock remains slow, with short-term mortality still reaching 40-50%, relatively unchanged in recent years. Despite advances with an increase in the number of clinical trials taking place in this admittedly difficult-to-study area, the evidence base on which we make day-to-day decisions in clinical practice remains relatively sparse. With only definitive evidence for early revascularisation and the relative ineffectiveness of intra-aortic balloon pumping, most aspects of patient management are based on expert consensus, rather than randomised controlled trials. This updated 2020 review will outline the management of CS mainly after acute myocardial infarction with major focus on state-of-the-art treatment based on randomised clinical trials or matched comparisons if available.



EuroIntervention: 26 Aug 2021; 17:451-465
Thiele H, de Waha-Thiele S, Freund A, Zeymer U, Desch S, Fitzgerald S
EuroIntervention: 26 Aug 2021; 17:451-465 | PMID: 34413010
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Impact:
Abstract

How to set up regional STEMI networks: providing best possible STEMI care.

Candiello A, Alexander T, Delport R, Toth GG, ... Baumbach A, Naber CK
Clinical guidelines recommend the development of ST-elevation myocardial infarction (STEMI) networks at community, regional and/or national level to offer ideally primary coronary angioplasty, or, at least the best available STEMI care to all patients. However, there is a discrepancy between this clinical recommendation and daily practice, with no coordinated care for STEMI patients in many regions of the world. While this can be a consequence of lacking resources, in reality, it is more frequently a lack of organizational power. In this paper, the Stent-Save a life! Initiative proposes a practical methodology to effectively set up a STEMI network in any region of the world, with existing resources, and to continuously develop the STEMI network once established.



EuroIntervention: 16 Aug 2021; epub ahead of print
Candiello A, Alexander T, Delport R, Toth GG, ... Baumbach A, Naber CK
EuroIntervention: 16 Aug 2021; epub ahead of print | PMID: 34387547
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Impact:
Abstract

Prediction of radial crossover in acute coronary syndromes: derivation and validation of the MATRIX score.

Gragnano F, Jolly SS, Mehta SR, Branca M, ... Romagnoli E, Valgimigli M
Background
The radial artery is recommended by international guidelines as the default vascular access in patients with acute coronary syndromes (ACS) managed invasively. However, crossover from radial to femoral access is required in 4-10% of cases and has been associated with worse outcomes. No standardised algorithm exists to predict the risk of radial crossover.
Aims
We sought to derive and externally validate a risk score to predict radial crossover in patients with ACS managed invasively.
Methods
The derivation cohort consisted of 4,197 patients with ACS undergoing invasive management via the randomly allocated radial access from the MATRIX trial. Using logistic regression, we selected predictors of radial crossover and developed a numerical risk score. External validation was accomplished among 3,451 and 491 ACS patients managed invasively and randomised to radial access from the RIVAL and RIFLE-STEACS trials, respectively.
Results
The MATRIX score (age, height, smoking, renal failure, prior coronary artery bypass grafting, ST-segment elevation myocardial infarction, Killip class, radial expertise) showed a c-index for radial crossover of 0.71 (95% CI: 0.67-0.75) in the derivation cohort. Discrimination ability was modest in the RIVAL (c-index: 0.64; 95% CI: 0.59-0.67) and RIFLE-STEACS (c-index: 0.66; 95% CI: 0.57-0.75) cohorts. A cut-off of ≥41 points was selected to identify patients at high risk of radial crossover.
Conclusions
The MATRIX score is a simple eight-item risk score which provides a standardised tool for the prediction of radial crossover among patients with ACS managed invasively. This tool can assist operators in anticipating and better addressing difficulties related to transradial procedures, potentially improving outcomes.



EuroIntervention: 10 Aug 2021; epub ahead of print
Gragnano F, Jolly SS, Mehta SR, Branca M, ... Romagnoli E, Valgimigli M
EuroIntervention: 10 Aug 2021; epub ahead of print | PMID: 34374343
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Impact:
Abstract

Feasibility and efficacy of an ultra-short side branch-dedicated balloon in coronary bifurcation stenting.

Murasato Y, Nishihara M, Mori T, Meno K, ... Takenaka K, Iwasaki K
Background
Side branch (SB) dilation with an ultra-short balloon after main vessel (MV) stenting may minimise stent failure in coronary bifurcation lesions.
Aims
We sought to investigate the feasibility and efficacy of the Glider balloon (GB), a side branch (SB)-dedicated balloon 4 mm in length, in coronary bifurcation stenting.
Methods
In bench testing, stent configuration was examined with micro-focus computed tomography after crossover stenting followed by GB dilation or kissing balloon inflation (KBI). In the clinical study we performed GB dilatation after MV stenting for 207 lesions in 194 patients. Failure of the GB dilation and additional procedures due to inducible stent failure were investigated as well as adverse cardiac events at 1-year follow-up.
Results
In bench testing GB dilation maintained cross-sectional stent area without significant deformation and presented effective jailed strut removal in a high-angled bifurcation model. In the clinical study the cohort included left main, true bifurcation lesion, and two-stent treatment in 42.0%, 45.9%, and 14.0%, respectively. The proximal optimisation technique (POT) or POT-like inflation was performed in 82.1%. GB crossing failure, SB stenting due to dissection, and stent deformation requiring correction by KBI or MV dilation occurred in 8.7%, 1.4%, and 5.8%, respectively. Finally, simple GB dilation without KBI was completed in 91.8% for SB dilation. At one-year follow-up, target lesion revascularisation, cardiac death, myocardial infarction, and stent thrombosis were found in 7.2%, 2.1%, 2.1%, and 1.0%, respectively.
Conclusions
Simple GB dilation after adequate expansion of the proximal MV stent provided acceptable acute and long-term results as an alternative to KBI.



EuroIntervention: 05 Aug 2021; 17:e425-e432
Murasato Y, Nishihara M, Mori T, Meno K, ... Takenaka K, Iwasaki K
EuroIntervention: 05 Aug 2021; 17:e425-e432 | PMID: 32657276
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Impact:
Abstract

Long-term outcomes of percutaneous coronary intervention for in-stent restenosis among Medicare beneficiaries.

Tamez H, Secemsky EA, Valsdottir LR, Moussa ID, ... Popma JJ, Yeh RW
Background
In-stent restenosis (ISR) is highly prevalent and leads to repeat revascularisation. Long-term implications of ISR are poorly understood.
Aims
This study aimed to evaluate the long-term outcomes of patients undergoing percutaneous coronary intervention (PCI) for ISR.
Methods
National Cardiovascular Data Registry CathPCI records for individuals aged ≥65 years undergoing PCI from July 2009 to December 2014 were linked to Medicare claims. Baseline characteristics and long-term rates of death, myocardial infarction (MI), repeat revascularisation including target vessel revascularisation (TVR), and major adverse cardiovascular and cerebrovascular events (MACCE) were compared between ISR PCI versus de novo lesion PCI.
Results
Of 653,304 individuals, 10.2% underwent ISR PCI and 89.8% underwent de novo lesion PCI. The median duration of follow-up was 825 days (quartile 1: 352 days-quartile 3: 1,379 days). The frequency of MACCE (55.6% vs 45.0%; p<0.001), all-cause mortality (27.8% vs 25.5%; p<0.001), MI (19.0% vs 12.3%; p<0.001), repeat revascularisation (31.9% vs 18.6%; p<0.001), TVR (22.4% vs 8.0%; p<0.001), and stroke (8.8% vs 8.3%; p=0.005) was higher after ISR PCI. After multivariable adjustment, ISR PCI remained associated with worse long-term outcomes than after de novo lesion PCI (hazard ratio [HR] for MACCE 1.24 [95% CI: 1.22, 1.26], mortality 1.07 [95% CI: 1.05, 1.09], MI 1.44 [95% CI: 1.40, 1.48], repeat revascularisation 1.55 [95% CI: 1.51, 1.59], and TVR 2.50 [95% CI: 2.42, 2.58]).
Conclusions
ISR PCI was common and was associated with a significantly higher risk of recurrent long-term major ischaemic events compared to patients undergoing de novo lesion PCI. There remains a need for new strategies to minimise ISR.



EuroIntervention: 05 Aug 2021; 17:e380-e387
Tamez H, Secemsky EA, Valsdottir LR, Moussa ID, ... Popma JJ, Yeh RW
EuroIntervention: 05 Aug 2021; 17:e380-e387 | PMID: 32863243
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Impact:
Abstract

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

Xhepa E, Bresha J, Joner M, Hapfelmeier A, ... Alfonso F, Kastrati A
Background
Drug-coated balloons (DCB) and drug-eluting stents (DES) represent the currently recommended treatments for in-stent restenosis (ISR). Optical coherence tomography (OCT) allows detailed neointimal characterisation which can guide treatment strategies.
Aims
The aims of this study were first, to assess the relation between neointimal pattern and clinical outcomes following in-stent restenosis (ISR) treatment, and second, to explore a potential interaction between neointimal pattern and treatment modality relative to clinical outcomes.
Methods
Patients undergoing OCT-guided treatment (DCB or DES) of ISR in three European centres were included. Based on the median of distribution of non-homogeneous neointima quadrants, patients were categorised into low and high inhomogeneity groups.
Results
A total of 197 patients (low inhomogeneity=100 and high inhomogeneity=97) were included. There were no significant differences in terms of major adverse cardiac events (MACE) (p=0.939) or target lesion revascularisation (TLR) (p=0.732) between the two groups. The exploratory analysis showed a significant interaction between neointimal pattern and treatment modality regarding MACE (pint=0.006) and TLR (pint=0.022). DES showed a significant advantage over DCB in the high (MACE: HR 0.26 [0.10-0.65], p=0.004; TLR: HR 0.28 [0.11-0.69], p=0.006), but not in the low inhomogeneity group (MACE: p=0.917; TLR: p=0.797).
Conclusions
In patients with ISR treated with DCB or DES, there were no significant differences in terms of MACE or TLR between the low and high inhomogeneity groups. A significant interaction was observed between treatment modality and neointimal pattern with an advantage of DES over DCB in the high and no difference in the low inhomogeneity group. This warrants confirmation from prospective dedicated studies.



EuroIntervention: 05 Aug 2021; 17:e388-e395
Xhepa E, Bresha J, Joner M, Hapfelmeier A, ... Alfonso F, Kastrati A
EuroIntervention: 05 Aug 2021; 17:e388-e395 | PMID: 32894230
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Impact:
Abstract

Culprit lesion location and outcomes in patients with multivessel disease and infarct-related cardiogenic shock: a core laboratory analysis of the CULPRIT-SHOCK trial.

Hauguel-Moreau M, Barthélémy O, Farhan S, Huber K, ... Thiele H, Montalescot G
Background
Critical culprit lesion locations (CCLL) such as left main (LM) and proximal left anterior descending (LAD) are associated with worse clinical outcome in myocardial infarction without cardiogenic shock (CS).
Aims
We aimed to assess whether CCLL identify a subgroup of patients with poorer prognosis when presenting with CS.
Methods
In the CULPRIT-SHOCK trial, a core laboratory reviewed all coronary angiograms to identify CCLL. A CCLL was defined as a culprit lesion with a >70% diameter stenosis of the LM, LM equivalent (>70% diameter stenosis of both proximal LAD and proximal circumflex), proximal LAD or last remaining vessel. We evaluated the primary study endpoint of the CULPRIT-SHOCK trial according to CCLL.
Results
A total of 269 (43%) out of 626 patients eligible for this analysis had a CCLL. Death or renal replacement therapy within 30 days, death within 30 days and death within one year were significantly higher in the CCLL than in the non-CCLL group (58.4% vs 43.4%, p<0.001, 55.8% vs 39.5%, p<0.001, 61.0% vs 44.5%, p<0.001, respectively). This was consistent after adjustment for baseline and angiographic characteristics. No interaction with the randomisation group (culprit lesion-only or immediate multivessel PCI) was found.
Conclusions
CCLL is frequent in CS and independently associated with worse clinical outcomes irrespective of the revascularisation strategy.
Trial registration
www.clinicaltrials.gov NCT01927549.



EuroIntervention: 05 Aug 2021; 17:e418-e424
Hauguel-Moreau M, Barthélémy O, Farhan S, Huber K, ... Thiele H, Montalescot G
EuroIntervention: 05 Aug 2021; 17:e418-e424 | PMID: 32894227
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Impact:
Abstract

A randomised comparison of coronary stents according to short or prolonged durations of dual antiplatelet therapy in patients with acute coronary syndromes: a pre-specified analysis of the SMART-DATE trial.

Jang WJ, Lee JB, Song YB, Choi KH, ... Gwon HC, Hahn JY
Background
Data on direct comparison between various drug-eluting stents with short duration dual antiplatelet therapy (DAPT) are limited, especially in patients with acute coronary syndrome (ACS).
Aims
We sought to compare biodegradable polymer biolimus-eluting stents (BP-BES) with durable polymer everolimus-eluting (DP-EES) and zotarolimus-eluting stents (DP-ZES) in patients with ACS according to different durations of DAPT.
Methods
In the SMART-DATE trial, 2,712 patients with ACS underwent randomisation for allocation of DAPT (6 months [n=1,357] or 12 months or longer [n=1,355]) and type of stent (BP-BES [n=901]), DP-EES [n=904], or DP-ZES [n=907]). The primary endpoint was a composite of cardiac death, myocardial infarction, or stent thrombosis.
Results
At 18 months, the primary endpoint was attained by 2.6% with BP-BES, 2.0% with DP-EES, and 2.1% with DP-ZES (HR 1.29, 95% CI: 0.70-2.39, p=0.42 for BP-BES vs DP-EES and HR 1.23, 95% CI: 0.67-2.26, p=0.50 for BP-BES vs DP-ZES). The treatment effect of BP-BES for the primary endpoint was consistent among patients receiving 6-month DAPT as well as those receiving 12-month or longer DAPT (BP-BES vs. DP-EES, pinteraction=0.48 and BP-BES vs DP-ZES, pinteraction=0.87). After excluding 179 patients (101 in the BP-BES group) who did not receive allocated DES, the per-protocol analysis showed similar results.
Conclusions
The risk of a composite of cardiac death, myocardial infarction, or stent thrombosis was not significantly different between patients receiving BP-BES versus DP-EES or DP-ZES across a short or prolonged duration of DAPT after ACS.



EuroIntervention: 05 Aug 2021; 17:e411-e417
Jang WJ, Lee JB, Song YB, Choi KH, ... Gwon HC, Hahn JY
EuroIntervention: 05 Aug 2021; 17:e411-e417 | PMID: 33136005
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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, ... Zamorano J, Dudek D
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: 05 Aug 2021; 17:e367-e375
Pristipino C, Germonpré P, Toni D, Sievert H, ... Zamorano J, Dudek D
EuroIntervention: 05 Aug 2021; 17:e367-e375 | PMID: 33506796
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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: 05 Aug 2021; 17:e401-e410
Bor WL, Zheng KL, Tavenier AH, Gibson CM, ... van 't Hof AWJ, Ten Berg JM
EuroIntervention: 05 Aug 2021; 17:e401-e410 | PMID: 34031019
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Impact:
Abstract

Dual lumen microcatheters for recanalization of chronic total occlusions: A EuroCTO Club Expert Panel Report.

Pyxaras SA, Galassi AR, Werner GS, Avran A, ... Di Mario C, Mashayekhi K
Dual lumen microcatheters (DLMC) have become indispensable tools in the setting of percutaneous coronary intervention (PCI) of chronic total occlusion (CTO). Other than allowing preservation and treatment of bifurcated coronary branches within or in the proximity of the CTO-body, they enable the use of modified parallel wiring, antegrade dissection and re-entry, collateral selection and retrograde negotiation of the distal CTO-cap. This Euro-CTO consensus document describes current DLMCs and suggests a practical guide to anatomies and techniques in which these devices are applicable.



EuroIntervention: 02 Aug 2021; epub ahead of print
Pyxaras SA, Galassi AR, Werner GS, Avran A, ... Di Mario C, Mashayekhi K
EuroIntervention: 02 Aug 2021; epub ahead of print | PMID: 34338644
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Impact:
Abstract

Phasic Flow Patterns of Right versus Left Coronary Arteries in Patients Undergoing Clinical Physiological Assessment.

Seligman H, Nijjer S, van de Hoef TP, de Waard GA, ... Francis D, Petraco R
Background
Coronary blood flow in humans is known to be predominantly diastolic. Small studies in animals and humans suggest this is less pronounced or even reversed in the right coronary artery.
Aims
This study aims to characterise the phasic patterns of coronary flow in the left versus right coronary arteries of patients undergoing invasive physiological assessment.
Methods
We analysed data from the Iberian-Dutch-English Collaborators (IDEAL) Study. 482 simultaneous pressure and flow measurements from 301 patients were included in our analysis.
Results
On average, coronary flow was higher in diastole both at rest and during hyperaemia both in the RCA and LCA (mean diastolic-to-systolic velocity ratio was, respectively, 1.85±0.70, 1.76±0.58, 1.53±0.34 and 1.58±0.43 for LCArest , LCAhyp , RCArest and RCAhyp , p&lt;0.001 for between vessel comparisons). Although the type of RCA dominance affected the DSVR magnitude (RCAdom = 1.55 ± 0.35, RCAco-dom =1.40 ± 0.27, RCAnon-dom = 1.35, (SD not reported as n=3), systolic flow was very rarely predominant (DSVR was greater than or equal to 1.00 in 472/482 cases (97.9%) overall), with equal prevalence in the LCA. Stenosis severity or microvascular dysfunction had negligible impact on DSVR in both RCA and LCA (DSVR x hyperaemic stenosis resistance R 2 = 0.018, p=0.03 and DSVR x coronary flow reserve R 2 &lt;0.001, p=0.98).
Conclusions
In patients with CAD undergoing physiological assessment, diastolic flow predominance is seen in both left and right coronary arteries. Clinical interpretation of coronary physiological data should therefore not differ between the left and the right coronary systems.



EuroIntervention: 02 Aug 2021; epub ahead of print
Seligman H, Nijjer S, van de Hoef TP, de Waard GA, ... Francis D, Petraco R
EuroIntervention: 02 Aug 2021; epub ahead of print | PMID: 34338643
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Impact:
Abstract

Safety of Early hospital discharge following admission with ST-elevation myocardial infarction treated with percutaneous coronary intervention: a nationwide cohort study.

Yndigegn T, Gilje P, Dankiewicz J, Mokhtari A, ... Fröbert O, Mohammad MA
Background
The Second Primary Angioplasty in Myocardial Infarction (PAMI-II) risk score is recommended by guidelines to identify low-risk patients with ST-elevation myocardial infarction (STEMI) for an early discharge strategy.
Aims
We aimed to assess the safety of early discharge (≤2 days) for low-risk STEMI treated with primary percutaneous coronary intervention (PCI).
Methods
Using nationwide data from the SWEDEHEART registry we identified patients with STEMI treated with primary PCI during 2009-2017 of whom 8092 (26.4%) were identified as low risk with the PAMI-II score. Low risk patients were stratified according to their length of hospital stay (≤2 days vs. &gt;2 days) The main endpoint was major adverse cardiovascular events (MACE) including death, reinfarction treated with PCI, stroke or heart failure hospitalization) at one year using a Cox proportional hazard model with propensity score as well as an inverse probability weighting propensity score of average treatment effect to adjust for confounders.
Results
There were 1449 (17.9%) patients discharged ≤2 days of admission. After adjustment, the 1-year MACE rate were not higher for patients discharged at &gt;2 days from admission than patients discharged ≤2 days (4.3% vs. 3.2%; adjusted HR, 1.31 [95% CI, 0.92-1.87, p=0.14]) and no difference were observed regarding any of the individual components of the main outcome. Results were consistent across all subgroups with no difference in MACE between early and late discharge patients.
Conclusions
Nationwide observational data suggests that early discharge of low-risk patients with STEMI treated with PCI is not associated with an increase in 1-year MACE.



EuroIntervention: 02 Aug 2021; epub ahead of print
Yndigegn T, Gilje P, Dankiewicz J, Mokhtari A, ... Fröbert O, Mohammad MA
EuroIntervention: 02 Aug 2021; epub ahead of print | PMID: 34338642
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Impact:
Abstract

Twelve-month outcomes of the TaurusOne® Valve For Transcatheter Aortic Valve Implantation in Patients with Severe Aortic Stenosis.

Wang M, Song G, Chen M, Feng Y, ... Wu Y, Gao R
Background
In the last decade, Transcatheter Aortic Valve Implantation (TAVI) has rapidly developed in China. As TAVI progresses towards low surgical risk patients, the total number of TAVI procedures will grow exponentially. There is a need to develop a domestic TAVI device designed for Chinese patients.
Aims
To evaluate the safety and efficacy of a self-expanding valve (TaurusOne® transcatheter aortic valve system) in the treatment of patients with symptomatic severe aortic stenosis in China.
Methods
A prospective, multi-center, single arm study was designed to enroll 120 patients with symptomatic severe aortic stenosis receive TAVI using TaurusOne® valve. The primary endpoint was all-cause mortality at 1 year.
Results
From September 2017 to April 2019, 120 patients were enrolled (35% bicuspid aortic valve, mean Society of Thoracic Surgeon (STS) score 9.95%). 1-year mortality in 120 patients (follow-up rate, 100%), was 6.7% (upper 95% confidence interval: 12.9%) which was significantly lower than the performance goal of 30% (P&lt;0.0001). All stroke, myocardial infarction, paravavular leak ≥ moderate, new pacemaker implantation occurred in 4.4%, 1.8%, 0.8%, and 22.1% at 1-year. The hemodynamic results and quality of life scores also improved significantly. Patients with bicuspid valve had similar outcomes as those with tricuspid aortic valve.
Conclusions
The 1-year clinical results confirm the safety and efficacy of the TaurusOne® transcatheter aortic valve system in the treatment of patients with symptomatic severe tricuspid and bicuspid aortic stenosis.



EuroIntervention: 02 Aug 2021; epub ahead of print
Wang M, Song G, Chen M, Feng Y, ... Wu Y, Gao R
EuroIntervention: 02 Aug 2021; epub ahead of print | PMID: 34338639
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Impact:
Abstract

Membranous septum morphology predicting the risk of conduction abnormalities after transcatheter aortic valve implantation.

Jørgensen TH, Hansson N, De Backer O, Bieliauskas G, ... Nørgaard BL, Søndergaard L
Background
There is limited data on the association of membranous septum (MS) morphology and transcatheter heart valve (THV) implantation depth, and the development of new conduction abnormalities after transcatheter aortic valve replacement (TAVI).
Aims
To describe the morphology of the MS and predict the risk of new CA after TAVI based on the MS morphology and THV implantation depth.
Methods
Based on pre-procedural CT-scans the MS depth was measured for every 25% of the entire MS width in 272 TAVI-patients without pre-procedural bundle branch block (BBB) or pacemaker. Post-procedural CT-scans for THV implantation depth assessment were available in 130 of these patients.
Results
The MS depth was a median of 2.5mm (IQR 1.4 - 3.8) deeper at the posterior edge when compared to the anterior edge of the MS. New CA developed in 7.1% of patients in whom the THV did not cross the lower MS border at its anterior edge (3.6% with new BBB and high degree CA, respectively); in 18.8% of patients (15.6% with new BBB and 3.1% with new high-degree CA) where the THV overlapped the lower MS border by &lt;2.5mm and in 47.1% of patients (24.3% with new BBB and 22.9% with new high-degree CA) with THV overlap of the lower MS border by ≥2.5mm.
Conclusions
The difference of the MS depth and THV implantation depth measured at the anterior edge of the MS predicted new CA after TAVI.



EuroIntervention: 02 Aug 2021; epub ahead of print
Jørgensen TH, Hansson N, De Backer O, Bieliauskas G, ... Nørgaard BL, Søndergaard L
EuroIntervention: 02 Aug 2021; epub ahead of print | PMID: 34338638
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This program is still in alpha version.