bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy and safety of percutaneous patent foramen ovale closure in patients with a hypercoagulable disorder
Authors: Ben-Assa E , Herrero-Garibi J , Cruz-Gonzalez I , Elmariah S , Al-Bawardy R , Sakhuja R , Lima F.V , Mingming N , Inglessis I , Palacios I.F 
Published: November 2020

Abstract

Background
Transcatheter closure of patent foramen ovale (PFO) in patients with cryptogenic stroke reduce the rate of recurrent events. Although presence of thrombophilia increases the risk for paradoxical emboli through a PFO, such patients were excluded from the large randomized studies.

Purpose
To examine the effect of hypercoagulable state on clinical outcomes after PFO closure.

Methods
We retrospectively analyzed data of 800 consecutive patients undergoing percutaneous PFO closure at the Massachusetts general hospital. We compared the safety and efficacy of the procedure in patients with and without a hypercoagulable state. Periprocedural treatment included 3 months of anticoagulation followed by low dose aspirin.

Results
A hypercoagulable disorder was found in 239 patients (29.9%). There were no significant differences in baseline demographics, echocardiographic characteristics, procedural success rate, or complication rate between both groups. At median follow-up of 41.9 months there were no differences in the rate of stroke/transient ischemic attack (2.5% in non-hypercoagulable group vs. 3.4% in hypercoagulable group, log-rank test p=0.349). Survival analysis of composite outcome that included: ischemic neurologic event, reintervention and procedural or neurologic death did not show significant difference between groups (Log-rank p=0.122).

Conclusion
Percutaneous PFO closure is a safe and effective therapeutic approach for patients with cryptogenic stroke and an underlying hypercoagulable state

Funding Acknowledgement
Type of funding source: Public hospital(s). Main funding source(s): Research funds of the Massachusetts general hospital
Does left atrial appendage morphology have any impact on the results of percutaneous closure?
Authors: Constantin V , Cinaud A , Brigadeau F , Lepillier A , Pierre B , Deharo J.C , Defaye P , Montalescot G , Fauchier L , Mansourati J 
Published: November 2020

Abstract

Introduction
Transcatheter left atrial appendage (LAA) occlusion is an alternative treatment in patients with atrial fibrillation (AF), high CHADSVASC Score and a contra-indication to anticoagulants. This retrospective cohort study aims to evaluate the impact of LLA morphology on procedure outcomes.

Methods
Patients from eight French centers who underwent left atrial appendage occlusion from February 2012 to January 2017 were included in this retrospective cohort study. LLA morphology was described by preoperative cardiac computed tomography (CT). Clinical data and Transoesophageal echocardiography (TEE) or CT results were collected during follow-up.

Results
Among 469 included patients, LAA morphologies were described in 215 cases 45.8%), 150 patients (70%) were implanted with Watchman devices, 57 (26%) with Amplatzer devices and 8 procedures (4%) failed. LAA Morphology was Chicken Wing (34%), Windsock (45%), cauliflower (18%) and 3% had another morphology including Cactus.
There was no difference in patient characteristics between the different morphology groups. Mean follow-up was 9.6±11 months, during which 190 patients underwent LAA imaging (TEE in 171 and CT in 19 patients). There was no significant difference in the failure rate (p=0.72), duration of the procedure (p=0.065), peri-device leak (p=0.83) device-related thrombus (p=0.96) and the occurrence of stroke (p=1) during follow-up.

Conclusion
LLA morphology did not influence complication occurrence after occlusion in this cohort.

Funding Acknowledgement
Type of funding source: None
WATCHMAN versus ACP or amulet for left atrial appendage closure. Results from the LAARGE registry
Authors: Ledwoch J , Franke J , Akin I , Geist V , Weiss C , Zeymer U , Pleger S , Hochadel M , Mudra H , Senges J , Lewalter T , Brachmann J , Sievert H 
Published: November 2020

Abstract

Background
Several left atrial appendage (LAA) closure systems are available and due to differences in device design safety and efficacy of specific occluders derived from trials cannot be simply generalized to all devices.

Purpose
The present analysis sought to assess two contemporary LAA closure devices in clinical practice.

Methods
The present work represents a non-randomized sub-analysis of the prospective, multicenter, Left-Atrium-Appendage Occluder Register - GErmany (LAARGE) registry. The WATCHMAN (group 1) and the Amplatzer Cardiac Plug (ACP) or Amulet occluder (group 2) were assessed regarding technical success and procedural safety.

Results
A total of 641 patients at 38 centers were enrolled. Of them, 278 (43%) and 340 (53%) patients received the WATCHMAN and ACP/Amulet occluder, respectively. High technical success was achieved with a slight difference between the groups (96% in group 1 vs. 99% in group 2; p=0.007). Procedural safety did not differ (98% in group 1 vs. 97% in group 2; p=0.55). Chicken wing morphology of the LAA seemed to trigger the use of the ACP/Amulet (chicken wing in 36% of the cases in group 1 vs. 55% in group 2; p&lt;0.001). The Kaplan Meier estimated 1-year composite of death or stroke was 12.0% and 12.9%, respectively (Figure 1A). The respective rates for the composite endpoint of death, stroke or systemic embolism were 12.0% and 13.2% (Figure 1B).

Conclusions
Both the WATCHMAN and the ACP/Amulet occluder provide excellent procedural results with comparable implantation success and no differences regarding procedural safety and long-term effectiveness.
Figure 1. Composite endpoints at 1-year

Funding Acknowledgement
Type of funding source: Public Institution(s). Main funding source(s): Stiftung Institut für Herzinfarktforschung (IHF)
Machine learning for risk prediction of in-hospital mortality in adult cardiac surgery
Authors: Myslivecek L , Benedetto U.B 
Published: November 2020

Abstract

Background
Risk prediction plays a central role in clinical decision-making for patients undergoing cardiac surgery. The logistic EuroSCORE has demonstrated a dangerous calibration drift with the changing patient case-mix, resulting in a significant overestimation of mortality and risk-averse practice. Despite these limitations, it continues being used in the United Kingdom due to a lack of alternative validated models. It is urgent to find a replacement for EuroSCORE with a better calibrated prediction model. Machine learning models are increasingly used for risk prediction in medicine due to their potential of overcoming limitations of regression models. Precisely quantifying the risk of in-hospital mortality may better inform patient-centred decision-making and direct targeted quality improvement interventions.

Methods
This is a retrospective monocentric cohort study using prospectively collected fully anonymised data from the National Adult Cardiac Surgery Audit database, restricted to patients undergoing adult cardiac surgery at our institute from 1996 to 2017 (n=28,761). The aim was to develop a predictive model with improved discriminatory power and calibration using machine learning methods. Model calibration was assessed using the calibration belt method. Discrimination power of each model (area under the receiver operating characteristic curve [AUC]) was compared with the logistic EuroSCORE using the De Long's test.

Results
A time series of the observed:expected (O:E) ratio for the logistic EuroSCORE showed a linear decrease with a slope of −7.4x10–3. The calibration belt showed a significant risk overestimation across all risk categories (p&lt;0.001). Model discrimination was excellent over time, with a marginal but significant linear trend in reducing the AUC (p=0.03). Although miscalibration was detected for all models (p&lt;0.05), neural network achieved the best calibration with a test statistic of 13.3, followed by logistic regression (18.0), and EuroSCORE (228.7). The neural network achieved the highest AUC (0.82, 95% CI 0.78–0.85) of all models and was marginally non-significantly higher than that of the logistic EuroSCORE (0.79, 95% CI 0.75–0.83, p=0.056).

Conclusion
Our neural network model of cardiac surgery in-hospital mortality achieves slightly improved discriminatory power and significantly better calibration compared to that of EuroSCORE, making it more appropriate for dealing with the changing patient case-mix. Further model training on larger datasets with larger demographics is necessary. Clinical implementation of such models may reduce risk of overestimation of mortality.

Funding Acknowledgement
Type of funding source: None
Long-term outcomes following coronary artery bypass grafting: the role of off-pump strategy
Authors: Barili F , D'Errigo P , Rosato S , Grossi C , D'Ovidio M , Pagano E , Seccareccia F 
Published: November 2020

Abstract

Background
The debate on the advantages and limitations of off-pump (OPCAB) on long-term outcomes has not still arrived to a conclusion. This study was designed to compare the impact of OPCAB vs on-pump coronary artery bypass grafting (CABG) on long-term mortality and major adverse cardiac events (MACEs).

Methods
The PRIORITY project was designed to evaluate the long-term outcomes of 2 large prospective multicenter cohort studies on CABG conducted between 2002–2004 and 2007–2008. Data on isolated CABG were linked to 2 administrative datasets. Time-to-event methods were employed to analyze outcomes.

Results
The population consisted of 11021 patients who underwent isolated CABG (27.2% OPCAB) that were divided into development and validation datasets. The median follow-up time was 8 years (interquartile range 7.6–10 years) and was 100% complete. Unadjusted long-term survival was significantly worst for OPCAB, nonetheless the adjustment did not confirm OPCAB as a risk factor for mortality (HR 0.94, 95% CI 0.85–1.03, p=0.19). OPCAB was associated to an increased risk of MACE at 10 years (adjusted HR 1.14, 95% CI 1.06–1.23, p=0.001). Inside the MACEs, OPCAB was significantly related to increased incidence of rehospitalization for percutaneous cardiac intervention (PCI), (adjusted HR 1.33, 95% CI 1.16–1.53, p&lt;0.001), demonstrating to be an independent risk factor for PCI with an hazard that is 33% higher than on-pump CABG.

Conclusions
OPCAB did not affect long-term mortality but is associated with an increased long-term risk of repeat PCI. These findings may have important implications towards health resources allocation, particularly in a climate of cost containment of healthcare expenditures.

Funding Acknowledgement
Type of funding source: Public grant(s) – National budget only. Main funding source(s): Italian Minister of Health
Preoperative status and in-hospital complications of coronary artery surgery in patients with pre-diabetes and type 2 diabetes mellitus
Authors: Bezdenezhnykh N , Bezdenezhnykh A , Sumin A , Barbarash O , Kuzmina A , Gruzdeva O 
Published: November 2020

Abstract

Aim
To assess the preoperative status and the rate of in-hospital complications of coronary artery surgery (CABG) in patients with pre-diabetes compared to patients with type 2 diabetes mellitus (type 2 DM) and normoglycemia.

Materials and methods
708 consecutive patients who underwent CABG between 2011 to 2012 were included in the study. All patients without positive history of diabetes underwent an oral glucose tolerance test (OGTT). The lab findings were interpreted in accordance with the recommended diagnostic criteria for diabetes and other glycemic disorders.

Results
DM screening before coronary artery bypass grafting allowed to diagnose type 2 diabetes in 8.9% (n=63) and prediabetes in 10.4% (n=74) of the study population. The preoperative screening increased the number of patients with DM from 15.2% (n=108) to 24.1% (n=171), and with prediabetes from 3.0% (n=21) to 13.4% (n=95). The total number of patients with carbohydrate metabolism disorders increased from 18.2% (n=129) to 37.5% (n=266). All patients were enrolled into 3 groups based on their glycemic status: Group 1 - without carbohydrate metabolism disorders (n=442), Group 2 - pre-diabetes (n=95), Group 3 - type 2 DM (n=171). The analysis of in-hospital complications reported that patients with pre-diabetes more often underwent urgent peripheral artery bypass compared to the other two groups (p1–2=0.002 vs. p1–3=0.023). The highest rate of wound complications was found in patients with pre-diabetes (p1–2=0.012). In addition, a clear trend towards the rate of other in-hospital complications of CABG in the groups with pre-diabetes and diabetes was found. The regression analysis shows that type 2 DM was associated with the total number of significant complications (odds ratio (OR) 1.731, 95% confidence interval (CI) 1.131–2.626, p=0.012), prolonged in-hospital stay (OR 2.2229, 95% CI 1.412- 3.519, p&lt;0.001), the risk of urgent peripheral artery bypass (OR 1.638, 95% CI 1.009–15.213, p=0.020), multiple organ dysfunction syndrome (OR 2.911, 95% CI 1.072–7.901, p=0.039) and the need for hemostasis correction using the extracorporeal methods (OR 3.472, 95% CI 1.042–11.556, p=0.044). All the associations described above remained significant when pre-diabetes was introduced into the regression model and any carbohydrate metabolism disorder was considered as a potential predictor of in-hospital complications. Additionally, an association between pre-diabetes and diabetes and the risk of acute renal damage (OR 1.700, 95% CI 1.067–2.612, p=0.024) and wound complications (OR 1.547, 95% CI 1.073–2.231, p=0.019) was observed.

Conclusion
Pre-diabetes affects the in-hospital outcomes after CABG as well as diabetes mellitus. Our findings emphasizes the relevance of active preoperative detection of carbohydrate metabolism disorders.

Funding Acknowledgement
Type of funding source: None
Valvular calcium load assessment for predicting postprocedural paravalvular leakage: a comparison between surgical aortic valve replacement versus transcatheter implantation
Authors: Pollari F , Pfeiffer S , Grossmann I , Vogt F , Sirch J , Schwab J , Fischlein T 
Published: November 2020

Abstract

Background
Calcification of native aortic valve is a well known variable causing paravalvular leakage (PVL) following transcatheter aortic valve implantation (TAVI). However, there is currently no evidence to support the fact that patients with high calcium load could be better treated with surgical aortic valve replacement (SAVR).

Purpose
To assess the utility of preoperative assessment of valvular calcium load through computed tomography in patients affected by severe aortic valve stenosis undergoing SAVR or TAVI.

Methods
Between June 2016 and June 2018, 109 candidates for isolated SAVR through minimal invasive access underwent preoperative contrast enhanced multidetector computed tomography (MDCT) for the assessment of valve and aortic calcifications. Calcium load was quantitatively measured using a dedicated software in three regions on interest (aortic valve [AV], left ventricular outflow tract [LVOT] and device landing zone [DLZ], which is the sum of the earlier 2). Clinical, echocardiographic, and MDCT variables were collected and compared to a sample population of 107 patients that underwent TAVI (87 transfemoral, 20 transapical) for native aortic valve stenosis in the same period of time, in the same institution. A univariate and multivariate logistic regression analysis were performed on the whole study population to assess risk factors for the onset of postoperative PVL (any grade, defined as ≥ mild) at discharge.

Results
The two study groups were significantly different in terms of age (71.9±5 in SAVR; 81.5±6 in TAVI), gender (36% female in SAVR vs 51% in TAVI), Euroscore II (1.9%±0.8 in SAVR; 4.8%±2.7 in TAVI), annulus perimeter (79.5mm±8.2 in SAVR; 61.8mm±30.5 in TAVI), baseline ejection fraction (57%±8 in SAVR; 51%±12 in TAVI) and severe pulmonary hypertension (2%±13 in SAVR; 26%±44 in TAVI). Calcium load was not different between groups (DLZ 1066 mm3±716 vs 955mm3±639; total calcium in AV 987 mm3±678 vs 879 mm3±601; total calcium in LVOT 78 mm3±130 vs 77 mm3±100). 30-days-mortality was 1.8% in SAVR and 5.6% in TAVI group (p=0.17). At discharge, incidence of all grades PVL was 5.5% in SAVR (0.9% trace, 3.6% mild, 0.9% moderate) and 41% in TAVI group (12.1% trace, 25.2% mild, 3.7% moderate) (p&lt;0.05). On logistic regression on the whole study population, DLZ calcium (OR 1.1, 95% CI 1–1.2 for 100 mm3, p=0.003) and the use of TAVI (OR 24, 95% CI 7.7–78, p&lt;0.001) were identified as independently associated with the onset of PVL.

Conclusions
Aortic valve calcifications are a risk factor for the onset of PVL for both TAVI and SAVR. Nevertheless, the risk increases considerably with the use of TAVI. A deeper anatomical analysis of preoperative MDCT could improve the treatment selection and the outcome of patients affected by aortic valve stenosis.

Funding Acknowledgement
Type of funding source: None
Defying challenges: mid-term outcomes of international collaborations for a successful heart transplantation program in the middle east
Authors: Hamour I.M , Ferrer R , Atallah B , Gabra G , Soliman M , Sabbour H , Bader F 
Published: November 2020

Abstract

Introduction
Heart transplantation (HTx) is a successful treatment strategy for advanced heart failure. Survival rates exceed those achieved by medical therapy alone. Lack of suitable donors and cultural perception remain obstacles for receiving this novel therapy.

Methods
Overcoming challenges we adopted a first-of-a-kind multicenter HTx program, collaborating between Cardiac Centers in India and the United Arab Emirates (UAE). Patients were worked up as part of our newly established HTx program in the UAE, then referred to India for successful HTx. All post HTx follow-up care was continued in the UAE thereafter.

Results
We assessed 10 HTx recipients, [90% male; mean age 34 yrs]. Five patients required inotropes while one LVAD support pre transplant. Our data outline short waiting-list time and excellent 3 years clinical outcomes.
All patients are maintained on Tacrolimus and Mycophenolate Mofetil. Two patient developed acute rejection (celluar and humoral) with graft dysfunction within 18 months.
Seventy percent had non-ischemic cardiomyopathy pre-transplant. Three acquired donor transmitted coronary vascular disease. One patient developed aggressive allograft vasculopathy requiring coronary artery bypass grafting. Acute kidney injury requiring renal replacement therapy occurred in 1 patient.

Conclusion
Defying logistic challenges, donor availability and long HTx waiting list times, we have established a successful multi-center new concept HTx program with excellent mid-term outcome result. Diverse genetic background is evident in the presence of early coronary vascular disease in young donor hearts, requiring extra care in donor screening. This international collaboration has a promising future for new programs in the Middle East.

Funding Acknowledgement
Type of funding source: None
Factors associated with the cardiac allograft vasculopathy after heart transplantation
Authors: Szczurek W , Gasior M , Skrzypek M , Romuk E , Zembala M , Szygula Jurkiewicz B 
Published: November 2020

Abstract

Introduction
Cardiac allograft vasculopathy (CAV) is a major threat to long-term survival after heart transplantation (HT). The frequency of CAV is estimated to be 8% at 1 year after HT, 30% at the 5-year follow-up, and as high as 50% within 10 years after the procedure. Therefore, it is necessary to select those factors that are closely associated with the presence of CAV and facilitate the proper, fast and minimally invasive diagnosis of this disease.

Purpose
The aim of this study was determine risk factors associated with CAV detection in patients after HT.

Material and methods
We analyzed 299 consecutive patients after HT who underwent routine visits in our institution between 2015 and 2017. During the visit, echocardiography, routine coronary angiography, laboratory tests and immunosuppressive drug serum concentrations were performed in all patients. In addition, 10 ml of peripheral blood was collected to determine human interleukin 33 (IL-33) and IL-1 Receptor Like 1 (IL1RL1). IL-33 and IL1RL1 concentrations were measured by sandwich enzyme-linked immunosorbent assay (ELISA) with the commercially available kit. The diagnosis of CAV was based on the results of coronary angiography and defined according to the current International Society for Heart and Lung Transplantation (ISHLT) criteria.The Medical University Local Institutional Review Board approved the study protocol, and all patients provided informed consent.

Results
Patients' median age was 59.00 (45.00–66.00) years, and 74.2% were men. The median time from HT to study inclusion was 9.03 (6.02–13.01) years. The frequency of CAV according to the ISHLT criteria in the analysed population was 47.5%. At the time of enrolment all patients were receiving immunosuppressive therapy with calcineurin inhibitor and mycophenolate mofetil, and were free from acute rejection (diagnosed either by echocardiography or biopsy), clinical signs of infection or symptoms of acute heart failure. Multivariate analysis using logistic regression confirmed that IL-33 OR 0.958 (0.944–0.972), p&lt;0.0001 as well as IL1RL1 OR 1.061 (1.040–1.083), p&lt;0.0001) serum concentrations, donor age OR 1.046 (1.009–1.085) p=0.015, left ventricular diastolic dimension OR 1.081 (1.016–1.149) p=0.015, and time from HT to blood collection OR 1.256 (1.151–1.371), p&lt;0.0001 were independent factors of CAV detection.

Conclusions
Lower IL-33 and higher IL1RL1 serum concentrations, as well as donor age, left ventricular diastolic dimension and time from HT to blood collection are independently associated with CAV. This study provides non-invasive, low-cost, and simple indicators for CAV detection.

Funding Acknowledgement
Type of funding source: Public Institution(s). Main funding source(s): Medical University of Silesia, Katowice, Poland