bluuebunny/crossref_metadata_2025_split huggingface dataset:
Reduction of major adverse and major cardiovascular events in patients with atrial fibrillation and stent implantation treated with left atrial occlusion device vs oral anticoagulants strategy
Authors: Lopez-Minguez J R , Suarez-Corchuelo E , Lopez-Tejero S , Nombela-Franco L , Freixa-Rofastes X , Bastos-Fernandez G , Millan-Alvarez X , Moreno-Gomez R , Fernandez-Diaz J A , Amat-Santos I , Benito-Gonzalez T , Alfonso-Manterola F , Navarro-Romero R , Cruz-Gonzalez I , Nogales-Asensio J M 
Published: October 2022

Abstract

Background
Treatment of patients with Nonvalvular Atrial Fibrillation (NVAF) who need coronary stent implantation is a challenge. Although trials have shown “direct anticoagulants (DOAC) indefinitely plus clopidogrel for one year” strategy reduces bleeding events in comparison to triple therapy, especially with warfarin, many questions remain about the safety and efficacy of this strategy.

Purpose
This study compared the events in patients who received left atrial appendage occlusion (LAAO) and antiplatelet therapy (APT) with those who were treated with oral anticoagulants (OAC) (including DOAC) and APT.

Methods
207 consecutive patients with NVAF who underwent coronary stent implantation (most of them for NSTEACS), were analysed. 146 were treated with OAC (75 with acenocoumarol, 71 with DOAC) and 61 with LAAO during a mean follow-up of 35 months. Furthermore, they received APT according to the clinical cardiologist criteria (Figure 1).

Results
There were no significant differences in variables like age (average 75.7 years-old) hypertension, diabetes, gender, permanent or paroximal AF or a history of stroke or thromboembolisms between groups. But there were more unfavourable characteristics in LAAO group with significant differences in the percentage of history of coronary artery disease (43.2% vs 75,4% p= &lt;0.001), CHA2DS2-VASc (4.07±1.70 vs 4.56±1.53 p=0.033), history of relevant bleedings (BARC ≥2) (8.9% vs 49.2% p&lt;0.001), history of high bleeding risks defined as previous bleedings or HASBLED ≥3 (19.9% vs 62.3% p&lt;0.001) and HAS-BLED (1.63±1.09 vs 2.49±1.18, p&lt;0.001), between OAC and LAAO groups respectively.
Observed total death, stroke/TIA and relevant bleedings incidence rates (expressed per 100 patient-years) were higher in OAC- than in LAAO-group: 10.86 vs. 6.96% (HR: 1.56; p=0.183), 4.59 vs. 1.27% (HR: 3.61; p=0.084), 12.43 vs. 4.57% (HR: 2.72; p=0.014), respectively. The composite events of MAE and MCVE (defined as in Figure 1 and 2) were also significantly higher: 23.40 vs. 9.8% (HR: 2.40; p=0.002) (Figure 2, left) and 7.41 vs. 1.9% (HR: 3.90; p=0.025) (Figure 2, right), respectively.

Conclusions
In patients with NVAF receiving coronary stents, a LAAO strategy with APT, shows better results in MAE and MCVE than treatment with OAC (DOAC included) plus APT strategy in a long term-follow-up, despite more unfavourable variables in LAAO group.

Funding Acknowledgement
Type of funding sources: None.
Trends in percutaneous left atrial appendage occlusion and 1-year mortality: a nationwide cohort study
Authors: Juhl Madsen O , Lamberts M K , Fosboel E L , Gislason G , Olesen J B , Strange J E 
Published: October 2022

Abstract

Background
Percutaneous left atrial appendage occlusion (LAAO) is increasingly used for stroke prevention in high-risk patients with atrial fibrillation and contraindication for oral anticoagulation. However, studies evaluating comorbidities and mortality remain scarce.

Objectives
The aim of this study was to evaluate changes in patient characteristic over time and 1-year risk of death.

Methods
Using Danish nationwide registers, we included all patients undergoing first-time LAAO between 2013 and 2021. To evaluate changes in patient characteristics, the study population was stratified according to calendar year of LAAO procedure: 2013–2015, 2016–2018, and 2019–2021. Baseline patient characteristics were defined from 10 years prior to date of LAAO procedure. Antithrombotic therapy was defined as claimed prescriptions within 180 days prior to LAAO procedure. Patients were then followed until either emigration, death, one year of full follow-up, or end of study period. Baseline frailty risk was estimated with The Hospital Frailty Risk Score, a validated frailty risk assessment tool based on ICD-10 codes. The 1-year unadjusted risk of death was estimated with the Aalen-Johansen method.

Results
In total, 1,306 patients underwent LAAO. The number of LAAO increased from 201 procedures in 2013–2015 to 586 in 2019–2021. During follow-up, the age of the patients remained stable (2013–2015: median age: 70 years; 2016–2018: median age 69 years; 2019–2021: median age 69 years). Fewer patients had a history of ischemic stroke (2013–2015: 44.3% vs 2019–2021: 27.6%), hemorrhagic stroke (2013–2015: 32.8% vs 2019–2021: 21.0%), and previous bleeding (2013–2015: 71.1% vs 2019–2021: 59.2%). Median CHA2DS2-VASs score decreased over time (2013–2015: 4 vs 2019–2021: 3) and same trend was found in median HAS-BLED score (2013–2015: 3 vs 2019–2021: 2).
In addition, fewer patients were categorized as high frailty risk (2013–2015: 16.9% vs 2019–2021: 8.9%). However, there was an increase in patients with a history of cancer (2013–2015: 11.9% vs 2019–2021: 18.9%). The use of antiplatelet therapy prior to LAAO decreased while the use of oral anticoagulation increased (2013–2015: 50.2% vs 2019–2021: 68.9%) due to a marked increase in non-vitamin K antagonist oral anticoagulants and a decrease in vitamin K antagonists (Figure 1).
In total, 88 (7.22%) patients died within one year of LAAO procedure. The 1-year all-cause mortality risk in each period were similar (2013–2015: 7.0%; 2016–2018: 7.1%; 2019–2021: 6.9%). [Figure 2]

Conclusion
In the years 2013–2021, the annual number of LAAO procedures increased. The age of patients remained stable. Comorbidity burden decreased and fewer patients were at high frailty risk, but the 1-year mortality risks were similar. Our real-life data suggest that profiles of patients undergoing LAAO has changed considerably over time.

Funding Acknowledgement
Type of funding sources: None.
Impact of bifurcation lesion on 10-year mortality in the SYNTAX trial
Authors: Ninomiya K , Serruys P W , Garg S , Gao C , Masuda S , Lunardi M , Burzotta F , Morice M C , Colombo A , Mack M J , Holmes D R , Davierwala P M , Thuijs D , Onuma Y 
Published: October 2022

Abstract

Background
Percutaneous coronary intervention (PCI) of bifurcation lesions is associated with higher rates of adverse events, and currently it is unclear whether PCI or coronary artery bypass grafting (CABG) is the safer treatment for these patients at very long-term follow up.

Objectives
To investigate the impact of bifurcation lesions on observed all-cause 10-year mortality in the SYNTAX trial.

Methods
In the SYNTAX Extended Survival study, 10-year observed mortality was compared among four groups: (a) presence of ≥1 bifurcation lesion and treatment with PCI (n=649), (b) no bifurcation lesion and treatment with PCI (n=248), (c) presence of ≥1 bifurcation lesion and treatment with CABG (n=651), and (d) no bifurcation lesion and treatment with CABG (n=239).

Results
Compared to patients without bifurcations, those with bifurcation lesion(s) treated with PCI had a significantly higher risk of all-cause death (19.8% vs 30.1%; HR: 1.55, 95% CI: 1.12 to 2.14; p=0.007), whereas following CABG, mortality was similar in patients with or without bifurcation lesion(s) (23.3% vs 23.0%; HR: 0.81, 95% CI: 0.59 to 1.12; p=0.207). (Figure1) There was a significant interaction between bifurcation lesion(s) and treatment arm (p for interaction=0.006).
In PCI patients, at 5-years there was no significant difference in mortality between 1- vs 2-stent techniques, whereas at 10-years, a 2-stent technique was associated with higher mortality (33.3% vs 25.9%; HR: 1.51, 95% CI: 1.06 to 2.14; p=0.021, Figure2).

Conclusions
Bifurcation lesion(s) require special attention from the heart team discussion, considering the higher 10-year all-cause mortality associated with PCI. Careful evaluation of bifurcation lesion complexity may be helpful in decision-making.

Funding Acknowledgement
Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): The SYNTAX Extended Survival study was supported by the German Foundation of Heart Research (Frankfurt am Main, Germany). The SYNTAX trial, during 0-5 years follow-up, was funded by Boston Scientific Corporation (Marlborough, MA, USA). Both sponsors had no role in the study design, data collection, data analyses, and interpretation of the study data, nor were involved in the decision to publish the final manuscript. The principal investigators and authors had complete scientific freedom.
Appropriateness of the modality of revascularization according to the SYNTAX 2020 in the FASTTRACK CABG study
Authors: Ninomiya K , Serruys P W , Masuda S , Kageyama S , Kotoku N , Onuma Y 
Published: October 2022

Abstract

Objectives
To compare the modality of revascularization selected by the local heart team to the one recommended by the core laboratory according to the SYNTAX score 2020 amongst patients with three-vessel disease (3VD) with or without left main disease (LMCAD), who were allocated to CABG planned and solely guided by coronary computerized tomographic angiography in the FASTTRACK CABG trial.

Background
Personalized long term vital prognosis plays a key role in deciding between PCI and coronary artery bypass grafting (CABG) in patients with complex coronary artery disease.

Methods
In an interim analysis requested by the Data Safety Monitoring Board the treatment recommendations according to the SYNTAX 2020 were prospectively assessed in 57 consecutive patients (half of the planned population in this First in Man) by a core laboratory and compared to the decision of the “on site” heart team.

Results
According to SS-2020, the predicted absolute risk difference (ARD) in mortality between the virtual PCI treatment population and the CABG treatment group, which can be considered a virtual surrogate for the average treatment effect, increased with the duration of follow up, from 4.8±3.5% at 5 years to 8.8±5.1% at 10 years (Table 1). The ARD of less than 0% in mortality at 5-year in favour of PCI was only documented in two patients while the 55 remaining patients had a predicted survival benefit over PCI if receiving CABG. However, based on a novel threshold of equipoise (ARD &lt;4.5%) recently validated in a contemporary registry of 3VD and LMCAD, CABG was mandatory in 26 (45.6%) patients, whereas PCI or CABG could have been equally selected in 31 (54.4%) patients (Figure 1).

Conclusions
According to the SYNTAX Score 2020 there was a strict observance of the CABG treatment recommendation in the first 57 consecutive patients with 3VD or LMCAD, screened on site in the FAST TRACK CABG trial. The more lenient selection criteria derived from the contemporary regitry will have to be tested propectively. Application of artificial intelligence with expanded collection of baseline characteristics, scientific endorsement and regulatory enforcement as well as further prospective evaluation are the challenges of future decision-making scores, that should be ultimately shared with the patients.

Funding Acknowledgement
Type of funding sources: None.
Redo cardiac surgery in the era of percutaneous solutions: pattern of presentation and outcomes in a single tertiary care center
Authors: Montella A P , Golini Petrarcone C , Palmieri L , Galbiati D , Amarelli C , De Feo M , De Santo L S 
Published: October 2022

Abstract

Introduction
The advent of new medical and interventional approaches has recently impacted on the referral for redo surgical operations. Little is known on current practice pattern and outcomes.

Purpose
We reviewed our institutional experience of 10 years (January 2011–December 2020) in a single university affiliated center to document frequency, outcome, and complications of the various types of redo procedures.

Methods
Retrospective analysis of a prospectively collected computed institutional database developed according to STS/EACTS recommendations.

Results
During study period 616 patients were referred for redo cardiac procedures, of which 129 patients underwent either medical or interventional procedures (75 thrombolysis, 22 valve-in-valve, 19 native mitral and or tricuspid percutaneous treatment, 13 paravalvular leakage devices), 459 patients were operated on, and 28 patients were denied any invasive treatment because of futility. Study group included these 459 surgical patients with a mean age of 62±12.7 years (octogenarians 5.6%, female sex 52.8%, diabetes 19.5%, chronic kidney disease 30%, urgent/emergent status 34.8%, third-time sternotomy 9.8%). The EuroSCORE II averaged 25.7±15.4%. Study group patients represented a nearly constant subgroup over the 6890 patients operated over this decade. Most frequent surgical procedures were valve operations, which were accomplished in 48.6% (223 pts), whereas isolated coronary bypass surgery was performed in 1.9% (9 pts) only. Valve thrombosis, mechanical prosthesis malfunction, paravalvular leakage, bioprosthetic failure and endocarditis (87% on prosthetic valve) were the most frequent indications. Combined procedures were performed in 15.2% (70 pts). Aortic root, ascending and arch replacement procedures were performed in 10.9% (50 pts, aortic dissection 7.8%). Cardiac transplantation in the setting of previous cardiac surgery was performed in 13.1% (60 pts including: previous conventional procedures [29 pts], mechanical circulatory devices [28 pts, 25 left ventricular assist device and 3 total artificial heart] and re-transplantation [3 pts]). Other procedures were performed in 10.2% (47 pts). Overall hospital mortality was 23,9%, rates of major complications were: surgical revision for bleeding 2,9%, Acute Kidney Injury (I/F) 17,4%, prolonged mechanical ventilation 12,9%, stroke 2,7%. Age, surgical priority, endocarditis, and heart failure represented the major independent predictors of morbidity and mortality.

Conclusions
Although percutaneous solutions are increasing their consensus, the rate of redo cardiac surgical procedures remained stable during the last 10 years. Outcomes are satisfactory despite increasingly complex patients features. Careful Heart Team evaluation is mandatory.

Funding Acknowledgement
Type of funding sources: None.
Are severe mitral annular calcification still a contraindication to open surgery?
Authors: Cerillo A , Petrini F , Bugetti M , Iannone L , De Cillis P , Paduvakis J , Marchionni N , Stefano P 
Published: October 2022

Abstract

Background
Mitral annular calcifications are considered a contraindication to open mitral valve repair/replacement, being associated with a significant risk of rupture of the atrioventricular groove or prosthesis detachment/paraprosthetic leak. Recently a scoring system has been proposed, to quantify the severity of MAC and predict the success of transcatheter valve in MAC implantation.

Objective
We present a series of consecutive patients with MAC undergoing sugical mitral valve replacement in recent years.

Patients and methods
82 consecutive patients with MAC underwent open surgical correction from January 2019 at our centre. This was a complex cohort of patients with a high surgical risk profile (STS 5.3±3.2). The degree of MAC was moderate in 60 and severe in 22. Annular decalcification was required in 16 patients, and patch reconstruction of the AV groove in 4. The main predictor of the need for annular decalcification and reconstruction was the depth of calcium infiltration in the ventricular wall at CT. At intraoperative TEE only one patient had a significant paraprosthetic leak, that was repaired during a second short period of aortic cross-clamping. 30 days mortality was 1.2% (one patient), and 87% of patients were alive and well at one year.

Comment
The presence of significant mitral annular calcificaion per se should not be considered a contraindication to open mitral valve surgery. The depth of the calcifications in the ventricular wall, as measured at CT 3D multiplanar reconstructions is the best predictor of the need to decalcify/reconstruct the AV groove. Detailed imaging analysis is crucial for the success of the procedure.

Funding Acknowledgement
Type of funding sources: None.
The Pitfall of VA ECMO management in the Impella era
Authors: Shibao K , Kitamura C , Matushima Y , Yanai T , Shibata T , Honma T , Otsuka M , Fukumoto Y 
Published: October 2022

Abstract

Introduction
VA ECMO is effective in cardiogenic shock, but complications of cardiogenic pulmonary edema due to increased afterload are problematic. The advent of percutaneous left ventricular assist devices (Impella) has enabled effective reduction of left ventricular intraventricular pressure and has avoided these complications, but differential hypoxia can still occur during VA ECMO + Impella (Ecpella) management, requiring conversion to V-AV ECMO. Cases may be experienced.

Purpose
Elucidate the frequency of differential hypoxia and its pathogenesis, which requires the transition from VA ECMO to V-AV ECMO.

Methods
We retrospectively reviewed 52 consecutive patients who underwent E-CPR from January 2017 through November 2021 in our institute. 8 patients who received ECMO alone were excluded, and 44 patients were recruited. 22 patients underwent VA ECMO with IABP (VA ECMO + IABP group) and 22 patients underwent VA ECMO with Impella (VA ECMO + Impella group). The 30-day survival rate and the rate of transition VA ECMO to VA-V ECMO, The date just before VA ECMO to V-AV ECMO were assessed.

Results
The 30-day all-cause mortality was no significant difference between the two groups. 2 patients (9%) in the VA ECMO + IABP group and 8 patients (36%) in the VA ECMO + Impella group were transferred to V-AV ECMO (P=0.025). At the time of addition of V-AV ECMO, SaO2 (right radial artery) was 87±7.1% and 91.3±1.9% (p=0.112) in the VA ECMO + IABP and VA ECMO + Impella groups, respectively, and the P/F ratio was 86±37.1 and 95±24.6 (p=0.685). Mean pulmonary artery wedge pressure was 23±1.4 mmHg in the VA ECMO + IABP group and 16.3±3 mmHg in the VA ECMO + Impella group (p=0.0193), significantly lower in the Impella group.

Conclusion
The Impella group was more likely to have hypoxia due to factors other than cardiogenic pulmonary edema. In cases of cardiopulmonary arrest requiring V-AV ECMO management, differential hypoxia due to causes other than cardiogenic pulmonary edema may become apparent earlier in the Impella group, suggesting that careful management, including the addition of V-AV ECMO, is required.

Funding Acknowledgement
Type of funding sources: None.
Combining serum miR-144-3p and miR-652-3p as potential biomarkers for the early diagnosis and stratification of acute cellular rejection in heart transplantation patients
Authors: Perez-Carrillo L , Gimenez-Escamilla I , Snachez-Lazaro I , Trivino J C , Martinez-Dolz L , Portoles M , Tarazon E , Rosello-Lleti E 
Published: October 2022

Abstract

Background
There is a dire need for specific, noninvasive biomarkers that can accurately and early detect cardiac acute cellular rejection (ACR). Previously, we described miR-144-3p as an excellent candidate to detect Grade ≥2R ACR.

Purpose
Now, we investigated the combination of miR-144-3p with other differentially expressed serum miRNA that we previously described to improve diagnostic accuracy, mainly in mild rejection to avoid reaching severe stages.

Methods
We selected miR-652-3p, miR-6747-3p and miR-221-3p from a preliminary RNA-seq study to be validated by RT-qPCR on 212 consecutive serum samples from transplantation recipients undergoing routine endomyocardial biopsies to subsequently combine them with miR-144-3p results and investigate their diagnostic capability.

Results
We confirmed the miR-652-3p overexpression (p&lt;0.0001) and its capability to discriminate between patients with and without ACR of any grade (p&lt;0.0001), but not miR-6747-3p or miR-221-3p. The combined serum levels of miR-144-3p and miR-652-3p were significantly higher in patients with rejection regardless of posttransplantation time (p&lt;0.0001). This combination resulted in a diagnostic efficacy for 1R (AUC=0.794) and ≥2R (AUC=0.892) (p&lt;0.0001) that was superior to each biomarker alone. Furthermore, it was a strong independent predictor of ACR for 1R (odds ratio of 10.950, p&lt;0.0001) and ≥2R (odds ratio of 14.289, p&lt;0.01).

Conclusions
We demonstrated that an appropriate combination of blood-based biomarkers can exhibit greater efficiency for cardiac rejection diagnosis. The combined detection of abnormal expression of miR-144-3p and miR-652-3p in the serum of ACR patients can improve the diagnostic sensitivity of rejection at the early stage and contribute to increasing the diagnostic accuracy, mainly in the lower rejection grades.

Funding Acknowledgement
Type of funding sources: Public grant(s) – National budget only. Main funding source(s): National Institute of Health Carlos III European Regional Development Fund (ERDF)
Non-invasive diagnosis of cardiac rejection using small non-coding RNAs
Authors: Gimenez-Escamilla I , Perez-Carrillo L , Sanchez-Lazaro I , Martinez-Dolz L , Portoles M , Tarazon E , Rosello-Lleti E 
Published: October 2022

Abstract

Background
Endomyocardial biopsy is the standard technique for rejection surveillance in heart transplantation recipients and is an invasive method with important limitations and clearly associated with both a risk of procedural complications and serious long-term sequelae when performed repeatedly. All of these considerations highlight the need to identify non-invasive alternative methods capable of discriminating between the different grades of rejection and reducing the need for endomyocardial biopsy.

Purpose
We conducted a non-targeted transcriptomic study focused on identifying serum small non-coding RNAs, mainly aimed on the less studied types, to evaluate their diagnostic accuracy for detecting rejection episodes.

Methods
We included consecutive serum samples from transplant recipients undergoing routine endomyocardial biopsies. Non-coding RNA sequencing analysis (Illumina HiSeq 2500) was performed on 40 samples, 28 diagnosed with RCA (RCA Grade 1R, n=16; and RCA Grade ≥2R, n=12) and 12 samples without cardiac rejection.

Results
636 non-coding RNAs were detected among the scaRNAs, snoRNAs, snRNAs and miscRNAs biotypes. But, neither piRNA nor siRNA biotypes were detected. Of all of them, 41 were altered in patients with rejection Grade ≥2R, finding no alteration in the scaRNAs biotype. Three molecules of miscRNA biotype showed the best results with excellent diagnostic capacity in moderate/severe rejection: RN7SL840P (AUC=0.938, p&lt;0.01), Y_RNA [ENSG00000223302] (AUC=0.931, p&lt;0.0001) and Y_RNA [ENSG00000202273] (AUC=0.903, p&lt;0.001). In addition, RN7SKP5 showed a good capacity for the diagnosis of Grade ≥2R (AUC=0.806, p&lt;0.05) and preserving the accuracy at Grade 1R (AUC=0.781, p&lt;0.05).

Conclusions
The 6.5% of the small non-coding RNAs detected have differential expression in patients with acute cellular rejection. The non-detection of the piRNAs and siRNAs biotypes stands out, as well as the absence of alteration in the scaRNAs biotype. We propose serum miscRNA levels as potential biomarkers of cardiac rejection. We highlight the role of RN7SL840P due to its excellent diagnostic capacity for RCA, and RN7SKP5 since it also allows the detection of mild rejection.

Funding Acknowledgement
Type of funding sources: Public grant(s) – National budget only. Main funding source(s): National Institute of Health Carlos III European Regional Development Fund (ERDF)