bluuebunny/crossref_metadata_2025_split huggingface dataset:
P4709Subclavian CTO stenting using bilateral retrograde wrist approach
Authors: Petkoska D , Zafirovska Taleska B , Vasilev I , Antov S , Kedev S 
Published: October 2019

Abstract

Aims
To assess the procedural safety and results of subclavian artery stenting using bilateral retrograde radial (TRA) and/or ulnar approach (TUA).

Methods
We report 40 consecutive patients that underwent retrograde opening and stenting of the subclavian artery using wrist approach with contralateral control from the opposite TRA or TUA. Primary outcome was procedural success rate. Secondary outcomes were: presence of procedural complications, restenosis, MI, stroke or death and presence of any type of access site bleeding hemathoma. One year clinical follow up and duplex ultrasonography was done in all patients.

Results
The same technique was used in all patients: 6F guiding catheter Judkins right 4.0 was most frequently used (n=37) for coronary hydrophilic wire retrograde crossing of the occlusion and ballon predilatation. Exchange of wire was made with 0,035 guide wire. Balloon expandable stents were implanted solely through the short hydrophilic sheath, with contralateral contrast check. Contralateral injection strategy was used to confirm proper wire advancement within the lesion and optimal stent positioning. Most frequently used guide wire for CTO opening was CROSS IT 400. The average stent diameter was 7 mm (range 5.0–9.0 mm), and the average stent length was 29, 1 mm (range 15–80 mm).
38 procedures were successfully done using bilateral retrograde radial approach. Only two patients required transfer to transfemoral approach to open the subclavian chronic total occlusion. Minor access site bleeding complications were recorded in 4 patients. There were no other complications. Seven patients were discharged the same day, the others one day after admission. At follow up only one patient had symptomatic in stent restenosis and a balloon angioplasty was done inside the stent 3 years after the primary intervention, the patient was a smoker. One other patient had asymptomatic in stent restenosis documented 6 months after the intervention with duplex follow up.

Conclusions
Bilateral wrist access can be a successful and safe strategy in opening subclavian artery occlusions with a low rate of complications.
P4712Hyperbaric oxygen therapy enhanced circulating levels of endothelial progenitor cells and angiogenesis biomarkers, blood flow in ischemic area in patients with peripheral arterial occlusive disease
Authors: Li Y C , Lee F Y , Chua S , Yip H K 
Published: October 2019

Abstract

Background
Arterial atherosclerotic occlusive syndrome remains the leading cause of mortality and morbidity worldwide. Peripheral arterial occlusive disease (PAOD) is a manifestation of atherosclerosis in the lower extremities. In our previous preclinical study, hyperbaric oxygen (HBO) therapy improved ischemic PAOD mainly through an increase of vascular wall permeability and recruiting endothelial progenitor cells (EPCs) to enhance the angiogenesis and blood flow in the ischemic area.

Purpose
This study tested the hypothesis that hyperbaric oxygen (HBO) therapy enhanced the circulating levels of endothelial progenitor cells (EPCs), soluble angiogenesis factors and blood flow in ischemic area in patients with peripheral arterial occlusive disease (PAOD).

Methods
57 consecutive patients with PAOD undergoing the HBO therapy (3 atm for 2h/each time) were prospectively enrolled into the present study. The venous blood sampling was drawn for assessing the circulating levels of EPCs and soluble angiogenesis factors prior to and during five times of HBO therapy. Additionally, skin perfusion pressure (SPP), an indicator of blood flow at ischemic area, was measured by moorVMS-PRES.

Results
The results demonstrated that the circulating levels of EPCs (CD34+/CD133+/CD45dim, CD31+/CD133+/CD45dim, CD34+) and soluble angiogenesis factors (VEGF/SDF-1α/HGF/FGF) were significantly increased in post-HBO therapy than in pre-HBO therapy (all p<0.01). Additionally, Matrigel assay exhibited that the angiogenesis was significantly increased in post-HBO therapy than prior to the therapy (p<0.001). Furthermore, the SPP was significantly increased in ischemic area (i.e., plantar foot and mean SPP of the ischemic foot) in post-HBO therapy than in pre-HBO therapy (all p<0.01). Importantly, the HBO therapy did not show any complication and all the patients were uneventfully discharged without amputation.

Conclusions
HBO therapy augmented circulating levels of EPCs and angiogenesis factors as well as improved the blood flow in the ischemic area.

Acknowledgement/Funding
Kaohsiung Chang Gung Memorial Hospital, Taiwan Society of Stem Cell Research
P4720Mitraclip XTR device used for the treatment of functional tricuspid regurgitation provides significant reduction of annular size
Authors: Russo M , Zilbersac R , Werner P , Scherzer S , Taramasso M , Zuber M , Mascherbauer J , Andreas M 
Published: October 2019

Abstract

Background
Tricuspid valve regurgitation (TR) is a progressive disease strongly associated with increased cardiac and all-cause mortality. The transcatheter approach to this pathology has been recently described with promising results in the treatment of symptomatic patients despite optimal medical therapy. Development of annular dilation and leaflet tethering represent a continuous pattern in the pathophysiology of functional TR; for this reason, to reduce and stabilize the annulus is the goal of an efficacious therapy.

Purpose
In order to simplify leaflet grasping, the novel MitraClip XTRdevice has significantly longer clip arms compared to its predecessor. The increased grasping length could be able to apply a radial tension on the tricuspid annulus, reducing it in dimensions. Despite, the increased tension on the leaflets may theoretically impose a higher risk for leaflet tearing We analyzed our single-center experience in order to clarify the capability of the device in the feature of annular reshapement.

Methods
Five high-risk patients (4 females, 72 (quartiles 69–79) y.o., EuroSCORE II 10 (7.25–11.2)% affected by severe symptomatic functional TR were treated with MitraClip XTR implantation in tricuspid position. Right ventricular function was apparently preserved in all cases and the mean sPAP was 41 (quartiles 38–45) mmHg. Perioperative echo-results were collected prospectively and analyzed.

Results
Procedural success (defined as a reduction of more than 1 degree of TR) was achieved in 4 cases (80%). 3±1 devices were implanted per patient in the antero-septal commissure. The tricuspid annular diameter (measured in four chamber view) was reduced from 39 (quartiles 39–41) mm to 31 (quartiles 30–31) mm (p=0.043). Accordingly, the effective regurgitant orifice area (EROA) decreased from 110 (quartiles 70 to 160) mm2 to 45 (quartiles 9–55) mm2 (p=0.02) and the systolic VTI in the hepatic veins decreased by 42%. No significant increase of trans-valvular mean gradients was observed (2.5 (quartiles 2.25 to 2.75)) mmHg vs 3.75 (quartiles 3,75 to 4) mmHg; p=0.2) as well no cases of acute leaflet tearing.

Conclusion
The reduction in tricuspid annulus size with the novel XTRdevice represents an unexpected and interesting achievement of the procedure. A significant reduction of annular dimensions might provide a more durable reduction of functional TR. Long-term follow-up data will be required to clarify these initial results and as well as patient selection criteria.
P4727Comparing in-hospital outcomes of transcatheter mitral valve repair vs surgical mitral valve repair in patients with pulmonary hypertension
Authors: Ahmed A , Adegbala O , Akintoye E , Alhatemi G , Aldiwani H , Yassin A S , Khalid M , Mishra T , Ajam M , Abubakar H , Shokr M , Afonso L 
Published: October 2019

Abstract

Background
The comparative outcomes of transcatheter mitral valve repair with Mitraclip (TMVR) versus surgical mitral valve repair (SMVR) in pulmonary hypertension (PH) patients are underexplored.

Methods
The Nationwide Inpatient Sample (NIS) database was queried from 2009 to 2015 and those who underwent TMVR or SMVR with PH were identified. International Classification of Diseases (ICD) codes were used to identify the target population, primary and secondary outcomes. Propensity scores (PS) were calculated for each patient. A standardized morbidity ratio (SMR) weight was then calculated for each patient in both groups. Absolute standardized differences (ASD) were used to compare the baseline characteristics.

Results
We identified a total of 341 and 4,665 cases from NIS who underwent TMVR and SMVR, respectively, over the study period. The mean age of patients was 67 yrs. Patients who underwent TMVR were older (75 vs. 66, ASD =0.32). Women comprised 47.8% of TMVR admission while 42.16% of SMVR admissions were females. Patients who underwent TMVR had a significantly higher Elixhauser comorbidity score >4 (43.4% vs 34.2%, ASD =0.3). TMVR group had higher rates of previous myocardial infarctions (16.7% vs. 7.1%, ASD = 0.30), congestive heart failure (80% vs. 6.2%, ASD = 0.44), percutaneous intervention (PCI) (15.6% vs. 5.9%, ASD = 0.32), coronary artery bypass grafting (CABG) (22.8% vs. 2.7%, ASD = 0.63), cerebrovascular disease (13.5% vs. 5.5%, ASD = 0.27), chronic obstructive pulmonary disease (30.8% vs. 21.1%, ASD = 0.22)and chronic renal failure (43.1% vs. 18.9%, ASD = 0.54). Inpatient mortality was similar between the 2 groups (3.6% vs 6.2%, p=0.573). TMVR patients had less hemorrhage requiring transfusion (8.1% vs 21.1, p<0.001), acute kidney injury (22.2% vs 33.6%, p<0.001), pacemaker placement (1.20% vs 6.89%, p<0.001), cardiogenic shock (4.5% vs 11.5%, p=0.0012) and mechanical circulatory device need (3.9% vs 9.7%, p=0.003). The TMVR group had lower median hospital cost ($53,824 vs $68,311, p<0.001) and LOS (7.5 days vs 13.1 days, p<0.001).

Conclusions
While in-hospital mortality in PH patients after TMVR compared to SMVR, TMVR was associated with significantly lower periprocedural complications.
P4728Prognostic implications of the relationship between effective regurgitant orifice area and left ventricle end diastolic volume in patients with functional mitral regurgitation treated with MitraClip
Authors: Melillo E , Godino C , Ancona F , Sisinni A , Stella S , Capogrosso C , Camici P G , Denti P , Buzzatti N , Colombo A , Montorfano M , De Bonis M , Castiglioni A , Alfieri O , Agricola E 
Published: October 2019

Abstract

Background
The distinction between proportionate and disproportionate functional mitral regurgitation (FMR), based on the relationship between effective regurgitant orifice area (EROA) and left ventricle end diastolic volume (LVEDV), has recently been proposed as a possible new clinical and physiopathological concept to identify patients that could likely benefit from transcatheter mitral repair.

Purpose
The aim of our study was to explore the possible prognostic implications of the EROA/LVEDV ratio in patients with FMR treated with MitraClip.

Methods
Baseline EROA/LVEDV ratio was calculated in 72 patients with moderate-to-severe, symptomatic FMR treated with MitraClip. All patients underwent clinical, biochemichal and echocardiographic evaluation before MitraClip. EROA was calculated using PISA method. The primary outcome was a composite end-point of all-cause death or re-hospitalization for heart failure (HF).

Results
The median follow-up was 1 year. The primary outcome occurred in 25 patients (34.7%). The cut-off value of EROA/LVEDV ratio for primary outcome, identified by receiver operating characteristic curve, was 0.15 (p=0.007) with a sensitivity and specificity of 72 and 68%, respectively. Patients were divided in two groups according to the identified cut-off. Patients with higher ratio (Group I, n=35) presented a less dilated LV (LVEDVi: 113.2±33.4 mL vs 129.3±29.3 mL, p=0.033; LVESV: 140.7±49.0 mL vs 171.1±47.4 mL, p=0.010), a better LV systolic function (LVEF: 31.9±9.5% vs 27.8±5.8%, p=0.028) and a more severe MR (EROA: 44.5±12.9 mm2 vs 24.5±6.8 mm2, p<0.001; vena contracta: 7.4±1.5 mm vs 6.7±1.0 mm, p=0.045). Patients with lower ratio (Group II, n=37) showed a reduced prevalence of MV annular dilation (57.1% vs 91.7%, p=0.005) and a worse RV function (s'TDI: 9.2±2.2 cm/s vs 10.5±2.9 cm/s, p=0.039). At univariate analysis, EROA/LVEDV ratio >0.15 (HR = 2.467, 95% CI 1.017–5.982, p=0.046) and severe pulmonary hypertension (HR = 2.481, 95% CI 1.030–5.976, p=0.043) were associated with a worse clinical outcome. At multivariate Cox-regression analysis, both EROA/LVEDV ratio >0.15 and severe pulmonary hypertension were identified as independent predictors (HR 3.203, 95% CI 1–310–7.832, p=0.011; HR = 3.280, 95% CI 1.326–8.116, p=0.010, respectively).
Figure 1

Conclusion
Our data show that EROA/LVEDV ratio was an independent predictor of adverse clinical outcome in FMR patients treated with MitraClip. This preliminary experience shows that this index could help to identify subgroups of patients with potential different clinical benefits from MitraClip therapy. However, further and extended data are needed to provide more precise evidence.

Acknowledgement/Funding
None
P4732Sleep apnoea and cardiovascular events after coronary artery bypass grafting surgery
Authors: Koo C Y 
Published: October 2019

Abstract

Background/Introduction
Sleep apnoea (SA) is prevalent and independently associated with adverse cardiovascular events after percutaneous coronary intervention. Patients with complex and high-risk features are often referred for coronary artery bypass grafting surgery (CABG) and it remains unknown if SA is a risk marker.

Purpose
We evaluated the association between SA and major adverse cardiac and cerebrovascular events (MACCE) in patients undergoing non-urgent CABG.

Methods
This was a prospective cohort study conducted between November 2013 and December 2018. Patients from 3 public hospitals referred to a tertiary cardiac centre for non-urgent CABG were recruited for an overnight sleep study prior to CABG. The mean follow-up duration was 2.1 years.

Results
Among the 1007 patients who completed the study, SA (defined as apnoea-hypopnoea index ≥15 events per hour) was diagnosed in 513 patients (50.9%). Most of the patients underwent on-pump CABG (96.7%) and received a left internal mammary artery graft (95.2%). MACCE, a composite of cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke and unplanned revascularisation, occurred in 123 patients (12.2%). The crude incidence of MACCE was higher in the SA than the non-SA group (3-year estimate, 18.8% versus 11.7%; p=0.019). Likewise, the crude incidence of all-cause mortality (7.2% versus 4.3%; p=0.028), sudden cardiac death (3.9% versus 1.6%; p=0.028) and heart failure hospitalisations (10.9% versus 5.3%; p=0.001) was higher in the SA than the non-SA group. Multivariate Cox regression analysis demonstrated that SA was predictive of MACCE with an adjusted hazard ratio of 1.54 (95% confidence interval, 1.06–2.22; p=0.023), after adjusting for the effects of age, gender, body mass index, left ventricular ejection fraction, hypertension and chronic kidney disease.
Figure 1. KM curve for MACCE

Conclusion
Sleep apnoea is independently associated with increased MACCE in patients undergoing CABG. Further evaluation regarding the efficacy of treatment of sleep apnoea in patients undergoing CABG surgery is warranted.

Acknowledgement/Funding
Clinician Scientist Award from the National Medical Research Council of Singapore (NMRC/CSA-INV/002/2015)
P4744Patients with atrial fibrillation exhibit a systemic prothrombotic state attributable to impaired endogenous fibrinolysis
Authors: Gue Y X , Spinthakis N , Markides V , Wong T , Gorog D 
Published: October 2019

Abstract

Background
The association of atrial fibrillation (AF) with thromboembolic stroke due to stasis in the left atrium and left atrial appendage is well described. Whether AF is associated with a systemic prothrombotic state, detectable in peripheral blood, unclear. Previous studies have been inconsistent, with some very small previous studies (<30 patients each) variably indicating that patients with AF may have raised platelet reactivity and levels of antithrombin III, d-dimer, PAI-1 and t-PA-PAI complexes. These cumbersome laboratory tests of coagulation and fibrinolysis are not readily available in the clinical setting.

Purpose
It was our aim to compare, in peripheral venous blood, thrombotic and endogenous fibrinolytic profile of healthy volunteers and patients with newly diagnosed nonvalvular atrial fibrillation (NVAF), using a point-of-care technique.

Methods
In a prospective observational study, venous blood samples were taken from 98 healthy volunteers and 100 patients with newly diagnosed NVAF in the out-patient setting. Patients with newly diagnosed NVAF had venous blood tested before any treatment was initiated with aspirin or oral anticoagulation. Thrombotic status was assessed using the Global Thrombosis Test (GTT), a point-of-care test using native non-coagulated blood, assessed within 15 sec of blood withdrawal. The time to form an occlusive venous thrombus in native (non-citrated) blood, a measure of platelet reactivity (occlusion time, OT) and the time taken to spontaneous endogenous fibrinolysis to restore flow (lysis time, LT) were assessed.

Results
Basic blood tests (full blood count, renal and liver function, inflammatory markers) were normal in all subjects. The groups were matched for sex and race. Mean age of the healthy cohort was 34±8 years and patients 65±10 years.
Endogenous fibrinolysis was markedly impaired in patients with NVAF compared to healthy individuals as shown by markedly prolonged LT (median 2015s [interquartile range IQR 1555–2507] vs. 1124s [IQR 919–1554], p<0.ehz745.11201). There was no difference in platelet reactivity between patients and normal volunteers (369s [IQR 308–445]vs 368s [IQR 309–441], p=0.704). Sensitivity analysis was performed on a subgroup matched for age, sex and race. LT remained significantly longer in patients with NVAF compared to controls (1569s [IQR 1499–2244] vs. 1219s [IQR 943–1560], p=0.03), with no difference in platelet reactivity (p=NS).

Conclusion
In the largest study to date and using a clinically-friendly automated point-of-care technique, we show that patients with NVAF exhibit a systemic prothrombotic state, attributable to significantly impaired endogenous fibrinolysis compared with healthy volunteers. Further studies are needed to see if this could become a screening test for the prothrombotic state in patients with NVAF.

Acknowledgement/Funding
None
P4749Renal function worsening in factor-xa inhibitors vs phenprocoumon in patients with non-valvular atrial fibrillation and renal disease - insights from the RELOADED study
Authors: Bonnemeier H , Kreutz R , Enders D , Schmedt N , Haeckl D , Vaitsiakhovich T , Kloss S 
Published: October 2019

Abstract

Background
Data on the effectiveness and safety of Factor-Xa non-vitamin-K oral anticoagulants in patients with non-valvular atrial fibrillation (NVAF) and renal disease is scarce. Among others, our study aimed to investigate the risk of renal function worsening in new users of NOACs vs. phenprocoumon with renal disease.

Methods
We conducted a new user cohort study (one year washout period) in patients with NVAF overall and additionally with renal disease defined by either an extended list of ICD-10 codes (definition 1) or chronic kidney disease (CKD) stages 3 or 4 (definition 2). German claims data between January 1st, 2013 and June 30th, 2017 were utilized and a multiple Cox-regression was performed to calculate confounder-adjusted hazard ratios (HRs) for the risk of end stage renal disease (ESRD)/dialysis and acute kidney injury in new users of NOACs (rivaroxaban, apixaban and edoxaban) vs. new users of phenprocoumon.

Results
In the overall population 22,339 patients initiating rivaroxaban, 16,201 patients initiating apixaban, 2,828 patients initiating edoxaban and 23,552 patients initiating phenprocoumon were included. NOAC patients with renal disease (definition 1) initiating reduced doses comprised 2,121 initiators of rivaroxaban, 2,507 of apixaban and 292 of edoxaban. 7,289 patients of phenprocoumon were identified. Patients with CKD (definition 2) initiating reduced doses of Factor-Xa inhibitors comprised 1,216 initiators of rivaroxaban, 1,522 of apixaban, 166 of edoxaban and 3,513 of phenprocoumon. In the confounder-adjusted analysis, a beneficial effect for both, rivaroxaban and apixaban over phenprocoumon was seen for the risk of ESRD/dialysis for all populations (overall, renal definition 1 and renal definition 2). In addition, in the CKD population we found a statistically significant risk reduction related to acute kidney injury only for rivaroxaban initiators (44%). There was not sufficient data to conduct the analyses for edoxaban.
Figure 1

Conclusion
This is the first observational retrospective database study evaluating the effect of renal function worsening in Germany. Results indicate a beneficial effect for both, reduced doses of rivaroxaban and apixaban related to renal function worsening over time when compared to phenprocoumon. This effect was more pronounced for the risk reduction with rivaroxaban related to ESRD /dialysis and specifically also related to a significant risk reduction for AKI.

Acknowledgement/Funding
The study was funded by Bayer AG
P4752Apixaban 2.5 mg twice daily is effective and safe for patients with atrial fibrillation and combinations of advanced age, low body weight, and elevated creatinine: insights from ARISTOTLE
Authors: Zeitouni M , Giczewska A , Lopes R D , Wojdyla D , Christersson C , De Caterina R , Steg P G , Granger C B , Wallentin L , Alexander J H 
Published: October 2019

Abstract

Background
In ARISTOTLE, patients with atrial fibrillation and ≥2 dose-reduction criteria [age ≥80 years, weight ≤60 kg, and creatinine ≥1.5 mg/dL (133 μmol/L)] were randomized to apixaban 2.5 mg twice daily (b.i.d) or warfarin.

Purpose
To determine whether the apixaban dose adjustment in ARISTOTLE resulted in similar efficacy and safety compared to warfarin.

Methods
The effects of apixaban 2.5 mg b.i.d versus warfarin on stroke or systemic embolism, major bleeding and death in ARISTOTLE patients with ≥2 dose-reduction criteria were compared with the effects of apixaban 5 mg b.i.d in patients with 0 or 1 dose-reduction criterion.

Results
Of 751 (4.1%) patients with ≥2 dose-reduction criteria, 386 were assigned to apixaban 2.5 mg b.i.d and 365 to warfarin. Compared to patients with 0 or 1 dose reduction criteria (n=17,322), these patients had a higher risks of stroke/systemic embolism (HR =1.78; 95% CI [1.24–2.57]), major bleeding (HR =1.73; 95% CI [1.28–2.32]) and death (HR=3.21; 95% CI [2.69–3.83]), irrespective of whether they were assigned to apixaban or warfarin. The benefits of apixaban 2.5 mg b.i.d compared with warfarin on stroke or systemic embolism, major bleeding, and death in patients with ≥2 dose-reduction criteria were consistent with that of apixaban 5 mg b.i.d in patients with either 0 or 1 dose-reduction criteria (Figure).

Conclusions
While they are at higher overall risk, patients with appropriate dose reduction criteria have consistent benefits with apixaban 2.5 mg b.i.d. over warfarin. Additional analyses investigating the relationship between apixaban dose and both apixaban plasma concentrations and levels of thrombosis biomarkers are underway.

Acknowledgement/Funding
Bristol-Myers Squibb and Pfizer, Inc.