bluuebunny/crossref_metadata_2025_split huggingface dataset:
254New possibilities of thrombolytic therapy in patients with STEMI according to a multicenter clinical study FRIDOM1
Authors: Gerasimets E 
Published: October 2019

Abstract

Aim
To assess the efficacy and safety of the single bolus of a new Russian genetically engineered drug Fortelyzin® in comparison with the single bolus of drug Metalyse® in ST-segment elevation myocardial infarction patients with12 hours after symptoms onset.

Materials and methods
Clinical trial took place from 2014 to 2016 in 11 clinical centers in Russia, the study was planned as a non-inferiority study with an assessment of the main results of intention to treat. The study included 382 STEMI patients, who were randomized to the Fortelyzin® and Metalise® groups. Fortelyzin® was administered by bolus at a dose of 15 mg regardless of body weight, Metalise® was administered by bolus at a dose of 30–50 mg depending on body weight. Thrombolytic therapy was accompanied by anticoagulant, double antiplatelet therapy in standard dosages with subsequent planned or emergency percutaneous coronary intervention (PCI). The observation was carried out within 30 days from the moment of randomization.

Results
The reperfusion according to 90 min ECG data occurred in 80% and according to coronary angiographic data (TIMI 2 + TIMI 3) in 70%. The “no less effective” rating, conducted by the difference in the CAG criterion (TIMI 2 + TIMI 3) in the Fortelyzin® and Metalise® groups, was equal to 0.81% and did not go beyond the limit of the clinical significance of 12.5. The primary final combined point which includes the sum of deaths from any causes + repeated myocardial infarction + cardiogenic shock, in the Fortelyzin® and Metalise® groups was 12.63% and 12.56% (p>0.99), respectively. In a clinical study, no intracranial hemorrhage was observed in both groups. In the Fortelyzin® and Metalise® groups, one patient was observed with large bleeding according to TIMI and GUSTO classification. Minor bleeding was observed in the Fortelyzin® group – 3.7%, in the Metalysis® group – 10.5% (p=0.02).

Conclusion
In the clinical trial FRIDOM1, it was demonstrated that a single bolus administration of Fortelyzin® at a dose of 15 mg in combination with anticoagulant and double antiaggregant therapy followed by PCI, is no less effective and safe than the use of Metalise®.
Trial Registration: ClinicalTrials.gov NCT02301910

Acknowledgement/Funding
SuperGene
281Impact of complications on VA-ECMO support for cardiopulmonary support: analysis of 8,351 adult patients in Germany from 2007 to 2015
Authors: Becher P M , Schrage B , Schmack B , Sinning C , Fluschnik N , Waldeyer C , Seiffert M , Neumann J T , Bernhardt A M , Reichenspurner H , Zeymer U , Thiele H , Blankenberg S , Twerenbold R , Westermann D 
Published: October 2019

Abstract

Background
Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used for treatment of patients with critical cardiopulmonary failure. However, utilization of VA-ECMO support must be carefully weighed against possible complications. Therefore, we investigated the incidence and impact of complications on VA-ECMO support in one of the largest datasets of VA-ECMO therapy.

Material and methods
We analyzed complications and outcomes of all VA-ECMO procedures performed in Germany from 2007 to 2015 by using administrative data from the German Federal Health Monitoring System. For the present analyses all cases treated with VA-ECMO between 2007 and 2015 were identified and selected by the primary procedural code (OPS) for VA-ECMO (OPS code 8852.3).

Results
Among 8,351 patients undergoing VA-ECMO between 2007 and 2015, there were significant changes in complication rates over time such as increase in acute kidney injury (from 35.9% in 2007–2012 to 44.6% in 2013–2015), major bleeding (from 11.3% in 2007–2012 to 19.5% in 2013–2015 and abdominal ischemia (from 4.5% in 2007–2009 to 7.2% in 2013–2015). The incidence of stroke and limb ischemia did not differ over time. Procedure-related and ischemic complications were more frequently observed in non-survivors as compared to survivors (12.2% versus 15.3%, p<0.001) except for major bleeding (20.9% in survivors versus 15.0% in non-survivors, p<0.001). Multivariate analyses retained stroke and acute kidney injury as being significantly associated with 30-day in-hospital mortality, with respective OR [95% CI] of 1.7 [1.0–2.9] and 1.2 [1.1–1.3].

Conclusion
In one of the largest registries, major bleeding and ischemic events are the most common complications on VA-ECMO support. Ischemic complications seem to influence outcome more than bleeding complications. However, only stroke and acute kidney injury were independently associated with higher mortality rates. These findings should be incorporated in risk-benefit stratification when initiation of VA-ECMO and in prevention of complications to avoid additional morbidity and mortality in these critically ill patients.
P313ADGRL2 is an essential surface molecule for cardiac lineage specification and heart development
Authors: Cho H J , Lee C S , Lee J W , Yang H M , Kim H S 
Published: October 2019

Abstract

Background
Specific surface markers that enable monitoring of cell subsets would be valuable for establishing the conditions under which pluripotent stem cells (PSCs) differentiate into cardiac progenitor cells (CPCs) and cardiomyocytes (CMCs).

Methods and results
To verify whether a specific marker is expressed during heart development, we assessed its expression using the CLARITY technique. After immersion in a solution with a refractive index matching that of the CLARITY hybrid, the mouse embryo became transparent. After immunostaining the cleared embryo sample, Adgrl2 was exclusively observed in cardiac cells expressing α-SA at embryonic day E9.5 and E10.5. Our clarified 3D images and movies show that four chambers of the heart are fully developed at E10.5 but not at E9.5. At E9.5, Adgrl2 is observed at the ventricle and atrium, while Adgrl2 is present in all chambers of the heart at E10.5. Next, we performed LacZ (β-Gal) staining in heterozygous Adgrl2 KO embryos to evaluate Adgrl2 expression. As a result, LacZ staining showed that Adgrl2 was predominantly expressed in the heart during the embryonic developmental stage. Adgrl2 knockout in mice was embryonically lethal because of severe heart, but not vascular, defects. To examine the use of Adgrl2 as a bona fide CPC marker during heart development, we tracked Adgrl2 expression during early embryonic development. The heart of Adgrl2−/− embryos at E10.5 exhibited occlusion of the RV, and the expression levels of Gata4 and Nkx2.5 were not as high as those in wild-type and Adgrl2+/− embryos. Interestingly, the heart of Adgrl2−/− embryos, unlike those of wild-type and Adgrl2+/− embryos between E13.5 and E15.5 had a single ventricle revealing a ventricular septal defect. The specific expression pattern of Adgrl2 in PSC-derived cardiac lineage cells as well as in embryonic heart, adult mice, and human heart tissues.

Conclusion
We demonstrate that Adgrl2 plays a pivotal and functional role across all strata of the cardiomyogenic lineage, as early as the precursor stage of heart development. These findings shed light on heart development and regeneration.

Acknowledgement/Funding
Grants from “Strategic Center of Cell and Bio Therapy” (grant number: HI17C2085) and “Korea Research-Driven Hospital” (HI14C1277)
P329Residual platelet reactivity after pre-treatment with ticagrelor prior to primary percutaneous coronary intervention is associated with suboptimal myocardial reperfusion
Authors: Roule V , Heudel T , Lemaitre A , Bignon M , Ardouin P , Sabatier R , Blanchart K , Beygui F 
Published: October 2019

Abstract

Background
The evidence of a clinical benefit of P2Y12 inhibitor pre-treatment in primary percutaneous coronary intervention (PCI) and the relation between the level of platelet inhibition and myocardial reperfusion with newer potent P2Y12 inhibitors remain unclear.

Objectives
We aimed to assess the relationship between platelet reactivity at the time of primary PCI after pre-treatment with aspirin and ticagrelor and the post-PCI myocardial blush grade (MBG).

Methods
We prospectively included 61 patients. Platelet reaction units for ticagrelor (PRU) and aspirin reaction units (ARU) were measured using the point-of-care test VerifyNow before PCI. The high on-ticagrelor (PRU >208) and on-aspirin (ARU ≥550) platelet reactivity (HPR and HaPR) were assessed. Patients were divided into two groups according to MBG 3 or <3.

Results
MBG 3 was identified in 28 (46%) patients. Mean PRU was lower in such patients as compared to those with MBG <3 (155.82±90.91 vs 227.42±65.18; p=0.001) while mean ARU was similar between groups. HPR and HaPR were observed in 30 (49.2%) and 11 patients (18%), respectively. HPR but not HaPR was more frequent in the group with impaired MBG (66.7 vs 28.6%; p=0.003 and 21.2 vs 14.3%; p=0.48 respectively).
Table 1. Platelet reactivity results Verify Now at admission All Final Blush <3 Final Blush 3 p n=61 (100%) n=33 (54%) n=28 (46%) PRU P2Y12 194.56±85.32 227.42±65.18 155.82±90.91 0.001 Base 193.54±49.01 194.79±45.68 192.07±53.48 0.83 Inhibition of platelet aggregation (%) 15.61±29.85 5.7±17.55 27.29±36.79 0.007 ARU 463.97±76.45 472.58±72.5 453.82±81 0.34 PRU >208 30 (49.1%) 22 (66.7%) 8 (28.6%) 0.003 ARU ≥550 11 (18%) 7 (21.2%) 4 (14.3%) 0.48 Verify Now at day 1 n=57 n=30 n=27 p PRU P2Y12 40.86±41.43 47.27±45.87 33.74±35.35 0.21 Base 196.98±36.19 193.67±30.67 200.81±41.97 0.47 Inhibition of platelet aggregation (%) 79.8±17.96 76.37±20.54 83.77±13.78 0.11 ARU = Aspirin reaction units; PRU = P2Y12 reaction units.

Conclusion
In conclusion, our study shows that higher PRU and the subsequent HPR at the time of primary PCI, after pretreatment with ticagrelor, are the only correlates of post PCI MBG. These findings support the earliest possible loading with ticagrelor prior to primary PCI.

Acknowledgement/Funding
The study was supported by grants from Terumo. The funder has no role in any step of the study.
P577Early experience with the first pacemakers to directly connect with smart devices for remote monitoring
Authors: Tarakji K , Zweibel S , Seiler A , Roberts P , Shaik N , Silverstein J , Patwala A , Mittal S , Molon G , Augello G , Porfilio A , Holloman K , Varma N , Sears S , Turakhia M 
Published: October 2019

Abstract

Background
Remote monitoring is associated with improved patient outcomes; however, adoption and adherence to remote monitoring via home-based consoles remains suboptimal. BlueSync technology in new generation pacemaker and CRT-P models enables the implanted device to communicate directly with patient-owned, Bluetooth-equipped smartphones/tablets and an app (MyCareLink Heart). The app can automatically retrieve information from the cardiac device and transmit the data to the remote network, eliminating the need for traditional remote monitoring consoles.

Objectives
To characterize the communication process between implanted pacemakers and smart device remote monitoring apps by assessing the success of prescheduled remote transmissions in the first month of follow-up. Additionally, to assess the feedback of both patients and clinicians about the process of device pairing.

Methods
Enrollment in the BlueSync Field Evaluation began in April 2018 and was completed November 2018. Follow-up is ongoing. Prior to enrollment in the evaluation, patients completed the device pairing process with the app using their own compatible smartphone or tablet. Patient and clinician questionnaires were completed at the time of the device pairing process. After enrollment, successful completion of scheduled transmissions occurring in the first month were analyzed.

Results
Preliminary data includes 241 enrolled patients with mean age of 64.7±15.5 yrs (min 20, max 90 yrs), who completed device pairing between their implanted device and their smart device app. Of enrolled patients, 79% felt that the device paring was easy to do, 85% were satisfied with the amount of time it took to complete it, and 93% felt that they would be comfortable using the app. Clinicians reported that 67% of the device pairings took less than 20 minutes and 78% felt patients would be able to use the app independently. At the time of analysis 174 patients had at least one scheduled transmission within the first month, and collectively had a total of 322 scheduled transmissions. Out of these, 309 (96%, 95% CI: 93%-98%) were successfully completed.
MyCareLink Heart App

Conclusions
Initial experience with the world's first app based remote monitoring system for Bluetooth enabled pacemakers demonstrated success to scheduled transmissions in the first month across a wide range of patient ages. Patients and clinicians reported high satisfaction with this novel technology.

Acknowledgement/Funding
Medtronic PLC
P578Use of a smartphone application to increase adherence to medical treatment in patients with acute coronary syndrome: a randomized clinical trial
Authors: Garmendia C M , Miranda P , Verello E , Goyeneche M A , Furmento J F , Hasseb S , Trivi M , Costabel J P 
Published: October 2019

Abstract

Background
Adherence to cardiovascular medications following acute coronary syndrome (ACS) hospitalization is generally poor and is associated with increased risk of rehospitalization and mortality. There are still significant opportunities to identify simple and low-cost interventions that improve medication adherence and clinical outcomes.

Purpose
To evaluate the use of a digital platform for smartphones to improve adherence to medical treatment and outcomes for 90-days post discharge in patients hospitalized for ACS with or without ST-elevation.

Methods
This was a unicentric, single-blinded, randomized controlled trial enrolling 90 patients with an ACS event requiring hospitalization. The intervention consisted of a smartphone application which allowed for the loading of medication prescription together with reminder of the daily compliance. Patients in the intervention group (n=46) were equipped with the smartphone application. Patients in the control group (n=44) received written and oral instructions as per standard of care. The primary outcome was adherence to medical treatment measured at 90-days post discharge using the 8-item Morisky Medication Adherence Scale (MMAS-8). The secondary outcome was a composite of re-hospitalizations for ACS, consultations to the emergency department (ED), or unplanned visits to the clinic.

Results
The mean age of the population was 63.2±9.9 and 75.6% were male. At 90 days, 64.7% of patients using the smartphone application were adherent compared with 20.5% of patients in the control group (p<0.001). Patients in the intervention group had higher adherence (mean MMAS-8 score 7.52±1.25) compared with the control group (mean MMAS-8 score 6.47±1.23; p<0.001). The secondary outcome measures showed that there were no significant differences in patients using the smartphone application versus the standard of care (4.3% vs 15.9%, p=0.07, respectively).
Table 1 Variables Global (n=90) Control (n=44) Intervention (n=46) p MMAS-8 score 7±1.34 6.47±1.23 7.52±1.25 <0.001 Adherents 40 (44.4%) 9 (20.5%) 31 (67.4%) <0.001 Events 9 (10.1%) 7 (15.9%) 2 (4.3%) 0.071 ED consultations 9 7 2 Score assessment 8.85±1.4

Conclusions
In patients with ACS, the use of a smartphone application increased the medication adherence compared with the standard of care. These data suggest that there is potential for a simple, low-cost intervention to help patients adhere to medications.
ClinicalTrials.gov unique identifier: NCT03766789.
P582Real-world experience with ehealth telemonitoring in patients with hypertension
Authors: Blok S , Somsen G A , Stavrov B , Tulevski I I , Van Den Born B J H , Winter M M 
Published: October 2019

Abstract

Background
Hypertension is the strongest modifiable risk factor for cardiovascular disease worldwide, while incidence and prevalence remain high. Home-monitoring is known to improve blood pressure in patients with hypertension. Despite promising results, few home monitoring programs have successfully been integrated into daily care and little evidence exists on their cost-effectiveness. The Dutch HartWacht eHealth program, initiated in June 2016, is one of the first eHealth programs that is fully reimbursed and integrated into clinical practice.

Purpose
The purpose of the study is to demonstrate the effect of an integrated and cost-effective telemonitoring program in a real-life setting.

Methods
In the HartWacht program patients with uncontrolled hypertension (office BP >140/90) receive a blood pressure monitor that is connected to their smartphone and integrated with their personal electronic patient file. Measurements are checked by a dedicated health care team. If values exceed pre-defined thresholds, patients are contacted by the team for swift therapeutic action. In this study, the first results of the program are evaluated.
Comparisons were made between last office blood pressure before the program; average blood pressure of first week of home measurement (twice daily, morning and evening); and blood pressure of home measurement at three, six and twelve months after start.

Results
122 patients started the HartWacht program for hypertension (female: 57 (46.7%); mean age: 61.2 (±9.5) years; mean follow-up: 13.4 (±7.6) months; mean number of anti-hypertensive drugs at start of HartWacht: 1.8 (±0.9); mean number of medication changes per year during follow-up (including changes in dose): 1.0 (±1.6); mean number of contact moments per year during follow-up (including calls with nurse or cardiologist): 4.9 (±5.0)). At final follow-up, 67 patients participated at least one year. Others started later or stopped the program, mainly because of reaching normotensive values (n=22; home BP <135/85).
The mean last office systolic blood pressure (SBP) measurement (n=122) was 157.9 mmHg (±19.2). The mean home SBP in the first week (n=120) was 139.9 mmHg (±13.9). After 3 months the mean home SBP lowered to 133.8 mmHg (±14.9), a significant decrease compared to week 1 (mean: 6.1 (±13.8), p<0.001). After this moment the mean home SBP was stable: 132.5 mmHg (±12.6) at six months (n=99) and 132.2 mmHg (±12.4) at 12 months (n=67).
No correlation was found between the number of medication adaptations and/or contact moments with the healthcare team and reaching target values.

Conclusion
This integrated eHeatlh telemonitoring program demonstrates significant and persistent blood pressure reduction in a real-life setting. As measurements are continuously monitored, swift therapeutic action is guaranteed. The Dutch HartWacht program has proven to be cost-effective, is reimbursed, and has the potential to be scaled up (inter-)nationally.
P601Heart disease and pancreatic iron in thalassemia major
Authors: Meloni A , Pistoia L , Restaino G , Renne S , Giunta N , Righi R , Giuliano P , Riva A , Giovangrossi P , Vitucci A , Positano V , Pepe A 
Published: October 2019

Abstract

Background
Some preliminary data have postulated a correlation between pancreatic iron overload and heart iron and function in thalassemia major (TM) patients.

Purpose
In the present multicenter study we explored systematically the link between pancreatic iron and heart disease in a large cohort of TM patients.

Methods
We considered 880 TM patients (467 M, mean age 37.83±10.05 years) enrolled in the E-MIOT (Extension-Myocardial Iron Overload in Thalassemia) project. T2* measurements were performed over pancreatic head, body and tail and global value was the mean. Myocardial iron overload (MIO) was quantified using a T2* segmental approach. Biventricular function parameters were assessed by cine images. Late gadolinium enhancement (LGE) images were acquired to detect myocardial fibrosis.

Results
A significant correlation between pancreatic and cardiac iron was reconfirmed in this more numerous population and a normal pancreas T2* showed negative predictive value of 100% for cardiac iron.
LGE sequences were acquired in 273 TM patients and 84 (30.77%) of them showed macroscopic myocardial fibrosis. Global pancreas T2* values were significantly lower in patients with fibrosis (7.38±6.19 ms vs 11.91±9.79 ms; P<0.0001).
Sixty-four patients had at least one cardiac complication (arrhythmias, heart failure, pulmonary hyperthension, vascular disease). Patients with cardiac complications showed a significant lower global pancreas T2* (7.83±5.61 ms vs 12.76±10.34 ms; P=0.024). Specifically, global pancreas T2* values were significantly lower in patients with heart failure as well as in patients with arrhythmias and all patients with one of these two diseases had a pathologic global pancreas T2* value (see Figure).

Conclusion
Pancreatic iron is a strong predictor not only for cardiac iron, but also for cardiac complications supporting a more profound link between pancreatic iron and heart disease in TM.
P6093D echocardiography versus cardiovascular magnetic resonance in the evaluation of the right ventricle in patients with congenital heart disease after pulmonary valve replacement
Authors: Pluchinotta F R , Panebianco M , Piazza L , Tarzia P , Fusini L , Pepi M , Giugno L , Chessa M , Carminati M , Bussadori C 
Published: October 2019

Abstract

Background
Cardiac MR (CMR) is the gold standard for right ventricular (RV) quantification. Three-dimensional echo (3DE) is a relatively new technique which may offer a rapid alternative for the examination of the right heart. The purpose of this study was to investigate the clinical significance and interchangeability of these modalities to evaluate patients with congenital heart disease (CHD) who underwent percutaneous pulmonary valve implantation (PPVI) for RV outflow tract dysfunction.

Methods
36 patients who underwent PPVI were evaluated with 3DE and CMR to quantify the RV. RV volumes and ejection fraction (EF) were measured for both imaging techniques with commercially available softwares (Tomtec-Germany for 3DE and Medimatic-Netherlands for CMR data). Paired t-test, Bland-Altman analysis, and Pearson's correlation analysis were used as most appropriate to compare both measured techniques with CMR regarded as the reference standard.

Results
86% of the patients (31 patients) had adequate image quality on 3DE and was included in the study. Patients underwent both 3D echo and CMR within a mean of 9 days of each other and at a mean time of 3 years after PPVI. Compared to CMR, 3D echo significantly underestimated volumes in all patients and overestimate RV ejection fraction (EF). Mean RV End-diastolic Volumes (EDV) and End-Systolic Volumes (ESV) were significantly greater when measured by CMR compared to 3D echo (EDV: 99 ml/m2 vs. 85 ml/m2; p<0.01, ESV: 52 ml/m2 vs. 41 ml/m2; p<0.01). Mean RV EF was lower when measured by CMR compared to 3D echo (48% vs 52%; p<0.05). Linear regression analysis showed high correlation coefficients between 3DE and CMR (r=0,68 for EDV, r=0,62 for ESV, and r=0,57 for EF; p<0.001). Bland-Altman analysis demonstrated that for both RV EDV and RV ESV there was a significant and systematic under-estimation of volume by 3D echo compared to CMR. Both 3DE and CMR measurements were found to be highly reproducible in terms of intra-observer variability.

Conclusions
Statistically significant and clinically meaningful differences in volumetric measurements were observed between 3DE and CMR in the evaluation of RV volumes and function in patients with CHD after PPVI. Despite linear regression and Bland-Altman analysis showed that the two techniques are related and present some degree of agreement, 3D Echocardiography systematically underestimates volumes and overestimates EF and this would have to be considered in the clinical practice.