bluuebunny/crossref_metadata_2025_split huggingface dataset:
Anticoagulation profile of high-dose vs. standard-dose enoxaparin for percutaneous coronary intervention
Authors: Liu Z , Chen Q , Li J , Zhu X , Xu L , Wu W 
Published: November 2020

Abstract

Background
Although enoxaparin 0.5 mg/kg is a recommended anticoagulation regimen for percutaneous coronary intervention (PCI), a randomized study demonstrated that more patients receiving enoxaparin 0.75 mg/kg compared to those receiving 0.5 mg/kg achieved therapeutic anticoagulation without increase of major bleeding. However, no detailed data regarding the anticoagulation profile of enoxaparin 0.75 mg/kg was reported in the study.

Purpose
This study prospectively assessed the anticoagulation profile of enoxaparin 0.75 mg/kg vs. 0.5 mg/kg in troponin-negative patients undergoing elective trans-radial coronary angiography (CAG).

Methods
Eligible patients were randomly assigned to the Planned Single-dose group (0.75 mg/kg) or the Planned Staged-dose group (0.5±0.25 mg/kg). In the Planned Single-dose group, all patients received enoxaparin 0.75 mg/kg before CAG irrespective of their indication for subsequent PCI. In the Planned Staged-dose group, enoxaparin 0.5 mg/kg was administered to all patients before CAG and additional 0.25 mg/kg was given only to those undergoing subsequent PCI immediately before PCI. Patients without indication for subsequent PCI in each group were defined as High-dose (0.75 mg/kg) and Standard-dose (0.5 mg/kg) groups, respectively. Anti-Xa levels were assessed at 0 min (immediately before), 10 min, and 90 min after enoxaparin administration. Therapeutic anticoagulation was defined as anti-Xa level of 0.5–1.8 IU/ml. Bleeding was according to the thrombolysis in myocardial infarction (TIMI) criteria.

Results
In 170 randomized patients, 48 of 85 patients in the Planned Single-dose group and 47 of 85 patients in the Planned Staged-dose group were included in the High-dose and Standard-dose groups, respectively. The baseline characteristics were well balanced between the two groups. The anti-Xa levels were higher in the High-dose vs. Standard-dose group both at 10 min (1.354±0.228 IU/ml vs. 0.976±0.213 IU/ml, p&lt;0.001) and 90 min (0.827±0.195 IU/ml vs. 0.583±0.169 IU/ml, p&lt;0.001) (Figure 1). The percentages of patients with therapeutic anticoagulation were similar at 10 min (100% [46/46] vs. 100% [46/46], p=1.000) but higher at 90 min (100% [41/41] vs. 75% [33/44], p=0.001) in the High-dose vs. Standard-dose group. No TIMI major or minor bleeding occurred within 24 h of randomization in both groups.

Conclusions
Enoxaparin 0.75 mg/kg compared to 0.5 mg/kg provided higher anticoagulation which was adequate for up to 90 min of administration. Enoxaparin 0.75 mg/kg would be a superior anticoagulation regimen for PCI, especially when the procedure duration is long.
Figure 1. High-dose vs. Standard-dose

Funding Acknowledgement
Type of funding source: Public hospital(s). Main funding source(s): 2016 Peking Union Medical College Hospital (PUMCH) Science Fund for Junior Faculty
Thirty-day incidence of stroke after transcatheter aortic valve implantation: a meta- and network meta-analysis comparing self-expandable versus balloon-expandable valve prostheses
Authors: Seppelt P.C , Mas-Peiro S , De Rosa R , Murray I , Fichtlscherer S , Zeiher A.M , Vasa-Nicotera M 
Published: November 2020

Abstract

Introduction
Stroke is a major and feared complication after transcatheter aortic valve implantation (TAVI). So far it is unknown, weather the valve deployment system itself has an impact on the incidence of periinterventional stroke. We sought to identify the incidence of 30-day stroke after transfemoral TAVI with self-expandable (SE) and balloon-expandable (BE) valves and performed a meta- and network meta-analysis to analyze differences related to the valve deployment system.

Methods
Overall 2706 articles were searched comparing directly the performance of SE and BE TAVI valves, from which 7 were included for analysis (one randomized controlled trial, 6 propensity score matching studies) with a total number of 2488 patients. Meta-analysis used random effects model and reported risk ratios (RRs). To compare different type of valves a random-effects network meta-analysis based on a frequentist framework for indirect and mixed comparisons was applied and reported odds rations (ORs). Using P-Score the relative ranking probability of each valve was estimated and the hierarchy of competing valves was obtained.

Results
Thirty-day incidence of stroke was 1.9% in SE (22 out of 1139, Medtronic CoreValve, Medtronic Evolut R and Pro, Boston Scientific ACURATE neo and St. Jude Medical Portico) and 3.1% in BE TAVI valves (42 out of 1349, Edwards Sapien 3 and XT) resulting in a RR of 0.65, (95% confidence interval (CI) 0.51 to 0.82). In accordance with the estimated P-Score CoreValve was the best effective for a reduction of 30-day stroke (72,5%) whereas the worst were Sapien 3 and XT (19.%). Combined direct and indirect evidence showed no superiority of CoreValve compared with Sapien valves (OR 0.469, 95% CI 0.13–1.64) concerning 30-day stroke incidence.

Conclusion
Our meta-analysis indicates a higher thirty-day incidence of stroke after TAVI with BE valves compared to SE valves. Furthermore, we could not find evidence for superiority of a specific valve system. Randomized controlled trials with head to head comparison of SE and BE valves are needed to address this open question.

Funding Acknowledgement
Type of funding source: None
Diabetes mellitus in transfemoral transcatheter aortic valve implantation in 11,440 patients from the CENTER collaboration
Authors: Van Nieuwkerk A.C , Santos R.B , Blanco Mata R , Tchethce D , De Brito F.S , Kornowski R , Latib A , Oteo-Dominguez J , Dumonteil N , D'Errigo P , Tarantini G , Lunardi M , Dangas G , Baan J , Delewi R 
Published: November 2020

Abstract

Background
Diabetes mellitus (DM) is a well-known cardiovascular risk factor present in up to a third of patients undergoing transcatheter aortic valve implantation (TAVI). How DM might influence outcomes after TAVI procedures remains controversial. The aim of this study was to determine differences in outcomes after TAVI according to diabetes status.

Methods
The CENTER (Cerebrovascular EveNts in patients undergoing TranscathetER aortic valve implantation with balloon-expandable valves versus self-expandable valves)-collaboration was a global patient level dataset of patients undergoing transfemoral TAVI from 2007 to 2018. In this analysis, the study examined differences in baseline patient characteristics, 30-day stroke and mortality, and in-hospital outcomes between DM and non-DM patients.

Results
Of the 11,440 patients included, 31% (n=3,550) were diabetic and 69% (n=7,890) were non-diabetic. Diabetics were younger, had a higher body mass index (BMI) and overall a worse cardiovascular risk profile than non-diabetics. There were no differences between DM and non-DM patients regarding in-hospital mortality (4.8% vs 5.3%, RR: 0.9, 95% CI: 0.7–1.1, p=0.46), myocardial infarction (0.9% vs 0.7%, RR: 1.4, 95% CI: 0.9–2.2, p=0.17), stroke (1.7% vs 2.0%, RR: 0.9, 95% CI: 0.6–1.2, p=0.36), major or life threatening bleeding (5.9% vs 6.3%, RR: 0.9, 95% CI: 0.8–1.1, p=0.44) and permanent pacemaker implantation (13.6% vs 13.4%, RR: 1.0, 95% CI: 0.9–1.1, p=0.69). Similarly, 30-day rates of all-cause mortality (5.4% vs 6.1%, RR: 0.9, 95% CI: 0.8–1.1, p=0.30) and stroke (2.0% vs 2.4%, RR: 0.8, 95% CI: 0.6–1.1, p=0.23) did not differ between diabetic and non-diabetic patients. Accordingly, in multivariate analysis, DM was not an independent predictor of mortality.

Conclusions
In this global collaboration, diabetic patients undergoing transcatheter aortic valve replacement had more cardiovascular comorbidities, were younger and had a higher body mass index than non-diabetics. They had similar periprocedural complications, in-hospital and 30-day mortality rates. In multivariate analysis, diabetes was not associated with increased mortality.
Predicted vs observed mortality in DM

Funding Acknowledgement
Type of funding source: Foundation. Main funding source(s): Dutch Heart Foundation; the Netherlands Organisation for Health Research and Development
Post TAVR coronary revascularization guided by stress cardiac imaging and impact on cardiovascular events
Authors: Lattuca B , Prunet E , Huet F , Akodad M , Manna F , Macia J.C , Schmutz L , Gandet T , Cayla G , Leclercq F 
Published: November 2020

Abstract

Background
The prognostic impact of systematic revascularization of asymptomatic coronary artery stenosis before transcatheter aortic valve replacement (TAVR) is still debated

Purpose
The main objectives of this study were to evaluate the feasibility and the safety of a functional evaluation of coronary artery disease (CAD) followed by a selective ischemia-guided percutaneous coronary intervention (PCI) after TAVR.

Methods
This prospective, bi-centric, one-arm, open-label trial included patients with severe aortic stenosis (AS) eligible for TAVR and with significant CAD defined as one or more coronary stenosis ≥70%. Patients with left main stenosis ≥50%, proximal left anterior descending artery (LAD) stenosis ≥90% or &gt; class 2 Canadian cardiovascular society angina pectoris were excluded. Coronary revascularization was not performed before TAVR and myocardial ischemia was evaluated by stress cardiac imaging one month after the procedure using Single-Photon Emission Computed Tomography Myocardial Perfusion Imaging or Stress Echocardiography using dobutamine infusion. The primary endpoint was the composite of all cause of death, stroke, major bleeding (Bleeding Academic Research Consortium (BARC) ≥3), major vascular complication (Valve Academic Research Consortium 2 criteria), myocardial infarction (MI) and hospitalization for cardiac causes at 6 months following TAVR.

Results
Between June 2016 and March 2019, 71 patients were included with a complete follow-up in 66 patients. The mean age was 84±5.2 years and the mean Euroscore was 13±8.6. Stress cardiac imaging could be achieved in 70% (n=46) of the patients and the main causes to not perform it were patient refusal or secondary impaired medical condition. Significant myocardial ischemia was observed in only 3 patients (4.5%), of whom 2 patients had successful PCI. The primary endpoint occurred at 6 months in 15 patients (23%) including death in 6 patients (9%), stroke in 3 patients (5%) and major bleedings in 3 patients (5%). Acute MI was observed in only 2 patients (3%) that had not-LAD proximal and severe coronary stenosis (≥90%). Hospital readmission (n=27, 41%) was mostly related to non-cardiac causes (n=18, 27%).

Conclusions
In patients scheduled to TAVR and with significant coronary disease, a strategy of selective ischemia-guided coronary revascularization after TAVR appears safe with a low rate of myocardial infarction and myocardial ischemia requiring revascularization during follow-up. However, the poor adherence of elderly patients to stress test could suggest to perform PCI of proximal and severe coronary lesions. Large-scale and randomized trials are warranted to validate this strategy.

Funding Acknowledgement
Type of funding source: None
How safe are current expert consensus recommendations for discharge after TAVI?
Authors: De Torres Alba F , Kaleschke G , Vormbrock J , Reinecke H , Deschka H , Baumgartner H 
Published: November 2020

Abstract

Introduction
How long patients (pts) remain at risk to develop conduction abnormalities (CAs) requiring pacemaker (PM) implantation after transcatheter aortic valve implantation (TAVI) and should therefore be monitored remains controversial. A recently published Expert Consensus Document (CD) proposes an ECG-based algorithm to risk-stratify patients and suggests early discharge of patients with low risk. Our institutional policy is to monitor all patients without previous PM for at least 7 days. We aimed to apply the discharge recommendations of this algorithm retrospectively to our patient cohort with prolonged and well documented ECG monitoring post-TAVI to evaluate the safety of this strategy.

Methods
We studied the development CAs in 1447 consecutive patients treated with Sapien 3 between January 2014 and December 2019. After excluding valve-in-valve procedures (n=30) and pts with previously implanted PM (n=167) 1254 remained for this analysis.

Results
Of 1254 pts, 159 (12.7%) developed high grade CAs requiring PM implantation after TAVI. 808 (64%) had no pre-existing right bundle branch block (RBBB) and no ECG changes immediately post-procedure (CD Group 1, hospital discharge recommended at day 1 post TAVI). Of these pts, 50 (6%) developed high grade CAs within the first 24 hours (h) after TAVI but 31 (3.8% of Group 1) after 24h (Figure 1, Panel A). 111 (8.9%) pts had pre-existing RBBB and no new ECG changes after TAVI (CD Group 2, hospital discharge recommended at day 2 post TAVI). In this group 27 pts (24%) developed high grade CAs within the first 48h after TAVI but 14 (12.6%) after 48h (Figure 1, Panel B). 62 pts had pre-existing CAs and had ECG-changes (CD Group 3, hospital discharge recommended at day 2 post TAVI if no progression). In this group 9 (14%) developed high grade CAs within the first 48h after TAVI but 5 (8%) after 48h (Figure 1, Panel C). 212 (17%) patients had a new-onset left bundle branch block (LBBB) after TAVI (CD Group 4, hospital discharge recommended at day 2 post TAVI if resolution/no progression); of these pts, 7 (3.3%) developed high grade CAs within the first 48h after TAVI and 13 (6.1%) after 48h (Figure 1, Panel D).

Conclusion
In this large TAVI cohort with a PM implantation rate of 12.7%, 40% of pts (5% of the entire population) would have been already discharged at the time they developed their CA when following recently published expert consensus recommendations. These results question the safety of the recommended early discharge algorithm and support a more conservative strategy.
Figure 1

Funding Acknowledgement
Type of funding source: None
Association of the get with the guidelines heart failure risk score with mortality in patients undergoing transcatheter edge-to-edge mitral valve repair
Authors: Iliadis C , Metze C , Spieker M , Kavsur R , Horn P , Westenfeld R , Tiyerili V , Becher M.U , Kelm M , Nickenig G , Baldus S , Pfister R 
Published: November 2020

Abstract

Background
Reliable risk scores in patients undergoing transcatheter edge-to-edge mitral valve repair (TMVR) are lacking. Heart failure is common in these patients, and risk scores derived from heart failure populations might help stratify TMVR patients.

Methods
Consecutive patients from three Heart Centers undergoing TMVR were enrolled to investigate the association of the “Get with the Guidelines Heart Failure Risk Score” (comprising the variables systolic blood pressure, urea nitrogen, blood sodium, age, heart rate, race, history of COPD) with all-cause mortality.

Results
Among 815 patients with available data 177 patients died during a mean follow-up time of 419 days. Estimated one-year mortality by quartiles of the score (0–37; 38–42, 43–47 and more than 47 points) was 6%, 10%, 23% and 30%, respectively (p&lt;0.001). Every increase of one score point was associated with a 9% increase in the hazard of mortality (95% CI 1.06–1.11%, p&lt;0.001). The score was associated with long-term mortality independently of left ventricular ejection fraction, renal function and LogEuroscore, and was equally predictive in primary and secondary mitral regurgitation.

Conclusion
The “Get with the Guidelines Heart Failure Risk Score” showed a strong association with mortality in patients undergoing TMVR with additive information beyond traditional risk factors. Given the routinely available variables included in this score, application is easy and broadly possible.

Funding Acknowledgement
Type of funding source: None
Incidence of intravascular hemolysis after transcatheter mitral valve repair
Authors: Paulus M , Meindl C , Hamerle M , Schach C , Maier L.S , Birner C , Debl K , Unsoeld B 
Published: November 2020

Abstract

Background
Chronic subclinical intravascular hemolysis is a common complication after valve replacement associated with worse prognosis, occurring in up to 80% of patients after mitral valve surgery. While serious intravascular hemolysis after MitraClip implantation has been reported anecdotally, data on the impact of transcatheter mitral valve repair on the prevalence of subclinical hemolysis are lacking.

Methods and results
From August 2017 to November 2019, 77 patients with high perioperative risk and moderate-to-severe or severe mitral regurgitation were prospectively enrolled in a single-center trial. All participants were treated with transcatheter edge-to-edge mitral valve repair using the MitraClip NT, NTR or XTR system. Before and three months after the procedure, all patients underwent comprehensive clinical assessment including laboratory measurement of hemoglobin, haptoglobin and lactic acid dehydrogenase in venous blood samples. Presence of subclinical intravascular hemolysis was defined as hemoglobin &lt;13.8 g/dl for males or &lt;12.4 g/dl for females, haptoglobin &lt;65 mg/dl and lactic acid dehydrogenase &gt;250 U/l. Levels of the hemolysis marker haptoglobin significantly decreased three months after the intervention (127±71 mg/dl at three months vs. 158±73 mg/dl at baseline, p&lt;0.001), accompanied by an increase in lactic acid dehydrogenase (251±88 U/l vs. 222±55 U/l, p&lt;0.01), implying the induction of intravascular hemolysis by transcatheter mitral valve repair. Higher residual mitral regurgitation was associated with lower haptoglobin levels three months after mitral valve repair (p&lt;0.05), hinting that shear stress caused by regurgitation flow is the primary mechanism for hemolysis after MitraClip implantation. Concurrently, we observed a trend towards an increase in the presence of subclinical intravascular hemolysis (9.1% at three months vs. 3.9% at baseline, p=0.289). Hemoglobin levels remained unchanged (12.1±1.5 g/dl at three months vs 12.3±1.8 g/dl at baseline, p=0.107). No patient needed treatment for intravascular hemolysis.

Conclusion
Transcatheter edge-to-edge mitral valve repair in a high-risk collective is associated with the induction of hemolysis. Yet, prevalence of subclinical intravascular hemolysis is low when compared to mitral valve surgery, emphasizing the good safety profile of minimal-invasive mitral valve therapy.

Funding Acknowledgement
Type of funding source: Public Institution(s). Main funding source(s): ReForM-B research grant, University of Regensburg
Can double internal thoracic artery grafts affect 10-year outcomes after coronary artery bypass grafting?
Authors: Barili F , D'Errigo P , Rosato S , Biancari F , D'Ovidio M , Pagano E , Seccareccia F 
Published: November 2020

Abstract

Background
The advantages of the employment of double internal thoracic artery grafts (BITA) for coronary artery bypass grafting have been recently questioned and no data on long-term follow-up are available. This observational retrospective cohort study was designed by the PRIORITY planning committee to evaluate 10-year follow-up of isolated CABG performed with and without BITA in order to clarify and consolidate the contrasting literature.

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 distributions were separately analyzed accordingly to primary event-type (death, MACEs), using Kaplan-Meier estimates and Cox regression.

Results
The population consisted of 11021 patients who underwent isolated CABG that were divided into development and validation datasets; double thoracic internal artery grafts was employed in 24.6%. The median follow-up time was 8 years (interquartile range 7.6–10 years) and was 100% complete. After adjustment for potential confounding factors, BITA was significantly associated with better survival (HR 0.85, 95% CI 0.76–0.95, p=0.003). Moreover, the employment of BITA reduced the incidence of MACEs at follow-up (adjusted HR 0.87, 95% CI 0.80–0.94, p=0.001). In details, BITA was demonstrated to be a protective factor for acute myocardial infarction (adjusted HR 0.84, 95% CI 0.71–0.99, p=0.05) and for rehospitalization for percutaneous cardiac intervention (PCI; adjusted HR 0.82, 95% CI 0.70–0.96, p=0.013).

Conclusions
The employment of double internal thoracic artery grafts for coronary artery bypass grafting has been associated to survival advantage at 10-year. Moreover, it significantly decreased the incidence of acute myocardial infarction and rehospitalization for percutaneous cardiac intervention.

Funding Acknowledgement
Type of funding source: Public grant(s) – National budget only. Main funding source(s): Italian Minister of Health
Earlier surgery improves long-term survival compared to class I surgical indications and infective endocarditis surgery for isolated severe tricuspid regurgitation
Authors: Wang T.K.M , Akyuz K , Xu B , Gillinov M , Pettersson G , Griffin B.P , Desai M.Y 
Published: November 2020

Abstract

Background
Isolated tricuspid surgery has markedly higher mortality rates (9–10%) in contemporary national registries compared to other single-valve operations. The optimal timing and indications remain controversial, and earlier surgery before developing ESC guidelines class 1 indications may improve the survival for isolated severe tricuspid regurgitation.

Purpose
We aimed to compare the characteristics and outcomes of isolated tricuspid regurgitation (TR) surgery by indication.

Methods
Consecutive patients undergoing isolated tricuspid valve surgery for TR without other concomitant valve surgery at Cleveland Clinic from 2004 to 2019 were studied. Indications were divided into group 1: ESC guidelines class 1 (severe symptomatic TR), group 2: infective endocarditis, and group 3: non-class 1 (asymptomatic severe TR with or without right ventricular dilation and/or dysfunction) and no endocarditis, for comparative analyses of characteristics and outcomes.

Results
The study included 207 patients (group 1: 115, group 2: 48 and group 3: 44) with mean age 54.1±17.8 years, 116 (56.0% females and 151. Tricuspid repair was performed in 72.9% (73.0%, 66.7% and 79.5% for Groups 1–3, P=0.381). Group 3 patients were younger, had higher prevalence of primary TR, lower prevalence of heart failure, atrial fibrillation, chronic lung disease, cirrhosis, renal impairment, right ventricular and left ventricular dysfunction than Group 1. Overall operative mortality rates were 4.9% ( group 1: 7.0%, group 2: 4.2% and group 3: 0.0%), while mortality during follow-up of 3.3±4.0 years was lower for group 3 than for groups 1 or 2 (Figure 1). Independent predictors of long-term mortality were Group 1 compared to Group 3 and reduced estimated glomerular filtration rate.

Conclusion
Patients without class I or endocarditis indications had superior unadjusted and adjusted survival compared to those with these indications. The high mortality rate of isolated TR surgery may be reduced by both earlier surgery and being performed at an experienced cardiac surgery center.
Figure 1. Kaplan-Meier survival curves

Funding Acknowledgement
Type of funding source: Foundation. Main funding source(s): National Heart Foundation of New Zealand - Overseas Clinical and Research Fellowship