Cost-effectiveness of adding a non-invasive acoustic rule-out test in the evaluation of patients with suspected stable angina pectoris. Design of the randomized multicenter FILTER-SCAD trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L Bjerking ◽  
K Hansen ◽  
T Biering-Soerensen ◽  
H Engblom ◽  
D Erlinge ◽  
...  
Keyword(s):  
Angina Pectoris ◽  
Diagnostic Tests ◽  
Funding Source ◽  
Cumulative Number ◽  
Significance Level ◽  
Non Invasive ◽  
Safety Endpoint ◽  
Acoustic Device ◽  
Rule Out

Abstract Background Patients with suspected stable coronary artery disease (CAD) are selected for further non-invasive or invasive diagnostic tests depending on their pre-test probability (PTP) of obstructive CAD. However, the PTP, based on age, sex, and type of angina, has shown to grossly overestimate the likelihood of obstructive CAD. Consequently, the use of diagnostic tests has increased over the last decades despite a low diagnostic yield (6–7%). The CAD-score is a risk stratification score for obstructive CAD measured using a novel non-invasive acoustic device, and when added to PTP has shown excellent rule-out capabilities. Purpose To investigate if the addition of the CAD-score to a standard diagnostic examination is superior in terms of reducing overall number of diagnostic procedures and non-inferior in terms of safety as compared to a standard PTP-guided strategy when evaluating patients with suspected stable CAD. Methods The FILTER-SCAD trial is a randomized, controlled, multicenter trial expected to include 2000 subjects ≥30 years of age without known CAD referred for outpatient assessment for suspected CAD at 5 hospitals in Denmark and Sweden. First subject was randomized on October 22, 2019. Subjects will be randomized 1:1 to either 1) a control group undergoing standard diagnostic examination (SDE) according to current guidelines, or 2) an intervention group undergoing SDE plus a CAD-score measurement, using permuted block randomization stratified by study site and PTP (very low vs. low-intermediate). Follow-up will be 12 months for a primary endpoint of cumulative number of diagnostic tests and a combined secondary safety endpoint of all-cause death, non-fatal myocardial infarction, unstable angina pectoris, heart failure, and ischemic stroke. Questionnaires assessing symptom severity, quality of life, life style measures, and medical treatment will be collected at baseline, 3 months, and 12 months after randomization. The study is powered to detect superiority in terms of cumulative number of diagnostic tests with a power of 80% and a significance level of 0.05, and non-inferiority on the safety endpoint with a power of 90% and a significance level of 0.05. The study is conducted in compliance to the principles of the Declaration of Helsinki of the World Medical Association. ClinicalTrials.gov ID: NCT04121949. Results One study site is currently enrolling. Preliminary baseline data is available on the first 77 (44% males) enrolled patients (median age 61 years IQR (51–72) and PTP 22% IQR (13–38)) showing successful randomization with even distribution of baseline characteristic between the two groups including sex, age, and PTP. Perspectives The FILTER-SCAD trial will investigate whether it is feasible to reduce resource consumption without compromising safety in the outpatient assessment of patients with suspected CAD using a simple, non-invasive acoustic device. Enrollment and follow-up are expected to be completed spring 2022. Funding Acknowledgement Type of funding source: Other. Main funding source(s): The company Acarix A/S har provided an unrestricted grant for the study. The Foundation “Fonden for Faglig Udvikling i Speciallægepraksis” has provided a grant for the study.

scholarly journals Association between variation of troponin and prognosis of acute myocardial infarction before and after primary percutaneous coronary intervention

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Z.X.X Zhao ◽  
W.Y Wang ◽  
L.C Liu ◽  
Z.P Zhou ◽  
S.Z.X Sheng ◽  
...  
Keyword(s):  
Angina Pectoris ◽  
Roc Curve ◽  
Troponin I ◽  
Cox Regression ◽  
Public Institution ◽  
Funding Source ◽  
Medical Sciences ◽  
Discrimination Power ◽  
Cox Regression Analysis

Abstract Background Circulating levels of cardiac troponin I (cTnI) after STEMI were considered prognostic factors for predicting MACE. ΔcTnI is the difference between peak cTnI post-primary PCI and cTnIon initial admission. Purpose Study aimed to assess the relationship between ΔcTnI, the ratio of ΔcTnI to cTnI on initial admission and MACE during the follow-up period. Methods A total of 2596 patients with cTnI measured upon admission and one-time measurement of cTnI during hospitalization were enrolled. Results In the adjusted models of the survival ROC curve, ΔcTnI and the ratio of ΔcTnI to cTnI on initial admission have stronger discrimination power of MACE [AUC 0.730 and 0.717] compared with peak cTnI post-PPCI and cTnI at admission (AUC 0.590, 0.546). Multivariate Cox regression analysis identified ΔcTnI [HR 1.018, 95% CI 1.001 to 1.035] as a relevant factor for MACE during follow-up. On the K-M survival curves,the incidence of MACE, mortality and angina pectoris were significantly higher in the group with maximum ΔcTnI (p=0.035, 0.049, 0.026). Conclusion ΔcTnI level and the ratio have stronger discrimination power of MACE. The group with maximum ΔcTnI has higher incidence of MACE, mortality and angina pectoris during the follow-up period. Flow chart + survival ROC curve + K-M curve Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): This study was supported by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences

scholarly journals Safety, feasibility and performance of Valvosoft non-invasive ultrasound therapy in patients with severe symptomatic calcific aortic valve stenosis. First-in-Man

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Messas ◽  
A Ijsselmuiden ◽  
G Goudot ◽  
S Vlieger ◽  
P Den Heijer ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Pressure Gradient ◽  
Ultrasound Therapy ◽  
Funding Source ◽  
Non Invasive ◽  
Post Procedure ◽  
Mean Pressure ◽  
Valve Opening ◽  
The Mean

Abstract Objectives We recently developed a unique transthoracic non-invasive ultrasound therapy device called Valvosoft to treat aortic stenosis. The therapy consists in delivering trans-thoracically precisely focused and controlled short ultrasound pulses (<20μsec) at a high acoustic intensity to produce non-thermal mechanical tissue softening of the calcified aortic valve with the ultimate aim of improving the valve opening. Ultrasound imaging enables to follow valve movements in real-time and thus targets the ultrasound waves on the valve with great precision. After having validated this concept in pre-clinical studies, we aimed at applying this technique in human. The primary objectives were to assess the safety and feasibility of this novel technique along with its performance by evaluation of the valve leaflets mobility and valve opening area. Methods This is a multi-center, prospective, controlled first-in-man study. Ten patients with severe symptomatic calcific aortic stenosis and not eligible for SAVR/TAVR underwent a Valvosoft ultrasound therapy. The therapy consists of 6 sessions of ultrasound therapy. The Valvosoft transducer is applied on the patient's chest and coupled at its center with an echocardiography phased array probe to allow real-time control of the therapy (cavitation bubble detection). Preselection of the region of interest is performed by echo still frame before each session. Ultrasonic evaluation was performed by an independent core lab at baseline, discharge, 30-day and 3 month follow-up along with clinical follow up. Results Enrolled patients were advanced in age (84.1±6.5 yrs) with severe comorbidities (8 with heart failure, 5 with coronary heart disease and 5 with kidney failure). All had extensive aortic valve calcification (mean calcification volume of 687.28 mm3) with mean AVA of 0.61±0.17 cm2 and mean pressure gradient of 37.5±10.5 mmHg (6 patients had SV<35ml/m2). No adverse events were recorded during the procedures other than some benign ventricular extrasystoles. The mean treatment time was 52 minutes. At 3 months follow-up, one patient had died due to end stage heart failure not linked to the procedure (9 weeks post procedure) and another got finally TAVI (45 days post procedure). Of the other 8 patients, 6 experienced an improvement of their NYHA status. No device or procedure related major adverse events nor deterioration of neurological status were observed at 3 months follow-up. Of the 7 patients that had echo follow-up at 3 months (one patient refused to get echo evaluation), 5 increased the AVA (between 14% and 46%) and 4 patients decreased the mean pressure gradient (from 6% to 44%). No AI or EF deterioration occurred during follow up. Conclusion Non-invasive ultrasound therapy is feasible and safe in patients with severe aortic valve stenosis and is able to improve AVA and pressure gradient in some patient. Larger studies with longer follow up will need to be conducted. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Cardiawave SA, Paris, France

scholarly journals Ten-year cardiovascular risk in patients with stable angina pectoris but without coronary artery disease by coronary angiography

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.K.W Olesen ◽  
H.E Botker ◽  
H.T Sorensen ◽  
M Maeng
Keyword(s):  
Cardiovascular Risk ◽  
Angina Pectoris ◽  
General Population ◽  
Coronary Angiography ◽  
Stable Angina ◽  
Funding Source ◽  
Stable Angina Pectoris ◽  
Artery Disease ◽  
Age And Sex

Abstract Background Patients with stable angina pectoris who do not have obstructive coronary artery disease (CAD) by coronary angiography are presumed to have a continued high cardiovascular risk despite no CAD. Purpose We examined the 10-year risk of myocardial infarction (MI), major adverse cardiovascular events (MACE), and death in elective patients with stable angina pectoris, but without CAD by coronary angiography compared to an age and sex matched general population cohort from Western Denmark. Methods We performed a cohort study of patients with stable angina pectoris without obstructive CAD by elective CAG examined between 2003 and 2016 in Western Denmark. Patients were compared to an age and sex matched general population comparison cohort without previous MI or coronary revascularization. Outcomes were MI, MACE (a composite of MI, ischemic stroke, and cardiac death), and death. Maximum follow-up was 10 years. Adjusted incidence rate ratios (IRRs) were computed using conditional Poisson regression. We also did a stratified analysis by sex and levels of comorbidity. Results A total of 18,491 patients suspected of angina pectoris without obstructive CAD, and 92,387 individuals from the general population were included in the study. Median follow-up was 8.6 years. Patients with chest pain but without CAD had reduced risk of MI (adjusted IRR 0.59, 95% CI 0.50–0.70, Figure), MACE (adjusted IRR 0.64, 95% CI 0.57–0.80), and death (adjusted IRR 0.62, 95% CI 0.59–0.67) compared to the general population when adjusting for potential confounders. Results were consistent when stratifying by sex and levels of comorbidity. Conclusions Absence of angiographic obstructive CAD in patients with symptoms of stable angina pectoris was associated with favorable low 10-year cardiovascular risk and mortality compared to the general population without known coronary status. Figure 1 Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): Department of Cardiology, Aarhus University Hospital

Aflibercept in real-life for the treatment of age-related macular degeneration using a treat and extend protocol: The Armada study

2021 ◽  
pp. 112067212110057
Author(s):  
Pierre Gascon ◽  
Prithvi Ramtohul ◽  
Charles Delaporte ◽  
Sébastien Kerever ◽  
Danièle Denis ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Real Life ◽  
Age Related Macular Degeneration ◽  
Cumulative Number ◽  
Treat And Extend ◽  
Treatment Interval ◽  
Age Related ◽  
Treatment Naïve ◽  
The Mean

Purpose: To report the visual and anatomic outcomes in treatment-naïve neovascular age-related macular degeneration (nAMD) patients treated with aflibercept under a standardized Treat and Extend (T&E) protocol for up to 3 years of follow-up in “real-life” practice. Methods: This retrospective, observational, multicenter study included patients with treatment-naïve nAMD and at least 12 months of follow-up. T&E regimen adjustment was initiated after loading phase. At each visit best-corrected visual acuity (BCVA) and optical coherence tomography parameters were performed. Results: One hundred and thirty-six eyes of 115patients had at least 1 year of follow-up with 114 and 82 eyes completing at least 2 and 3 years of follow-up, respectively (mean follow-up duration: 2.7 ± 1.3 years). Mean age was 78.6 ± 8.6 years old and 52% were women. Mean BCVA increased from 60.6 ± 18.7 letters at diagnosis to 66.9 ± 16.2 letters at 1 year (+6.3 letters, p = 0.003) and remained stable throughout the follow-up period (63.1 ± 20.3 letters (+2.5, p = 0.1) and 64.0 ± 20.1 letters (+3.4, p = 0.27) at 2 and 3 years, respectively). The mean central retinal thickness decreased significantly from 358.2 ± 87.9 µm at baseline to 302 ± 71.7 µm at 12 months and maintained stable after 36 months of follow-up (297.1 ± 76 µm, p < 0.0001). Mean number of injections was 6.6 ± 2.2, 4.8 ± 1.9, and 5.6 ± 1.7 at 1, 2, and 3 years, respectively. Mean cumulative number of 16.4 ± 5.6 injections after 3 years. Mean treatment interval was 6.8 ± 2.5 weeks at 1 year. Eight-week and 12-week treatment interval were achieved in 59.5% and 19.1%, 65.8%, and 36.8% and 69.5% and 41.5% at 1, 2, and 3 years, respectively. Conclusions: Our study demonstrated that intravitreal injections of aflibercept initiated under a standardized T&E for patients with treatment-naïve nAMD allow for significant visual improvement at 12 months, which was maintained over a 3-year follow-up period.

Creation of physiologic rhythm by closed loop stimulation in heart failure patients with severe chronotropic incompetence: worldwide first results of a pilot study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Proff ◽  
B Merkely ◽  
R Papp ◽  
C Lenz ◽  
P.J Nordbeck ◽  
...  
Keyword(s):  
Heart Rate ◽  
Closed Loop ◽  
Funding Source ◽  
Chronotropic Incompetence ◽  
First Results ◽  
The Mean ◽  
Group 2 ◽  
Group 1

Abstract Background The prevalence of chronotropic incompetence (CI) in heart failure (HF) population is high and negatively impacts prognosis. In HF patients with an implanted cardiac resynchronisation therapy (CRT) device and severe CI, the effect of rate adaptive pacing on patient outcomes is unclear. Closed loop stimulation (CLS) based on cardiac impedance measurement may be an optimal method of heart rate adaptation according to metabolic need in HF patients with severe CI. Purpose This is the first study evaluating the effect of CLS on the established prognostic parameters assessed by the cardio-pulmonary exercise (CPX) testing and on quality of life (QoL) of the patients. Methods A randomised, controlled, double-blind and crossover pilot study has been performed in CRT patients with severe CI defined as the inability to achieve 70% of the age-predicted maximum heart rate (APMHR). After baseline assessment, patients were randomised to either DDD-CLS pacing (group 1) or DDD pacing at 40 bpm (group 2) for a 1-month period, followed by crossover for another month. At baseline and at 1- and 2-month follow-ups, a CPX was performed and QoL was assessed using the EQ-5D-5L questionnaire. The main endpoints were the effect of CLS on ventilatory efficiency (VE) slope (evaluated by an independent CPX expert), the responder rate defined as an improvement (decrease) of the VE slope by at least 5%, percentage of maximal predicted heart rate reserve (HRR) achieved, and QoL. Results Of the 36 patients enrolled in the study, 20 fulfilled the criterion for severe CI and entered the study follow-up (mean age 68.9±7.4 years, 70% men, LVEF=41.8±9.3%, 40%/60% NYHA class II/III). Full baseline and follow-up datasets were obtained in 17 patients. The mean VE slope and HRR at baseline were 34.4±4.4 and 49.6±23.8%, respectively, in group 1 (n=7) and 34.5±12.2 and 54.2±16.1% in group 2 (n=10). After completing the 2-month CPX, the mean difference between DDD-CLS and DDD-40 modes was −2.4±8.3 (group 1) and −1.2±3.5 (group 2) for VE slope, and 17.1±15.5% (group 1) and 8.7±18.8% (group 2) for HRR. Altogether, VE slope improved by −1.8±2.95 (p=0.31) in DDD-CLS versus DDD-40, and HRR improved by 12.9±8.8% (p=0.01). The VE slope decreased by ≥5% in 47% of patients (“responders to CLS”). The mean difference in the QoL between DDD-CLS and DDD-40 was 0.16±0.25 in group 1 and −0.01±0.05 in group 2, resulting in an overall increase by 0.08±0.08 in the DDD-CLS mode (p=0.13). Conclusion First results of the evaluation of the effectiveness of CLS in CRT patients with severe CI revealed that CLS generated an overall positive effect on well-established surrogate parameters for prognosis. About one half of the patients showed CLS response in terms of improved VE slope. In addition, CLS improved quality of life. Further clinical research is needed to identify predictors that can increase the responder rate and to confirm improvement in clinical outcomes. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Biotronik SE & Co. KG

Coronary sinus catalase and ceruloplasmin levels predict all-cause mortality in patients with end-stage heart failure awaiting heart transplantation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
W Szczurek ◽  
M Gasior ◽  
M Skrzypek ◽  
G Kubiak ◽  
A Kuczaj ◽  
...  
Keyword(s):  
Heart Failure ◽  
Heart Transplantation ◽  
Coronary Sinus ◽  
Public Institution ◽  
Funding Source ◽  
Organ Shortage ◽  
Number Of Patients ◽  
End Stage ◽  
Medical University

Abstract   Background, As a consequence of the worldwide increase in life expectancy and due to significant progress in the pharmacological and interventional treatment of heart failure (HF), the proportion of patients that reach an advanced phase of disease is steadily growing. Hence, more and more numerous group of patients is qualified to the heart transplantation (HT), whereas the number of potential heart donors has remained invariable since years. It contributes to deepening in disproportion between the demand for organs which can possibly be transplanted and number of patients awaiting on the HT list. Therefore, accurate identification of patients who are most likely to benefit from HT is imperative due to an organ shortage and perioperative complications. Purpose The aim of this study was to identify the factors associated with reduced survival during a 1.5-year follow-up in patients with end-stage HF awating HT. Method We propectively analysed 85 adult patients with end-stage HF, who were accepted for HT at our institution between 2015 and 2016. During right heart catheterization, 10 ml of coronary sinus blood was additionally collected to determine the panel of oxidative stress markers. Oxidative-antioxidant balance markers included glutathione reductase (GR), glutathione peroxidase (GPx), glutathione transferase (GST), superoxide dismutase (SOD) and its mitochondrial isoenzyme (MnSOD) and cytoplasmic (Cu/ZnSOD), catalase (CAT), malondialdehyde (MDA), hydroperoxides lipid (LPH), lipofuscin (LPS), sulfhydryl groups (SH-), ceruloplasmin (CR). The study protocol was approved by the ethics committee of the Medical University of Silesia in Katowice. The endpoint of the study was mortality from any cause during a 1.5 years follow-up. Results The median age of the patients was 53.0 (43.0–56.0) years and 90.6% of them were male. All included patients were treated optimally in accordance with the guidelines of the European Society of Cardiology. Mortality rate during the follow-up period was 40%. Multivariate logistic regression analysis showed that ceruloplasmin (odds ratio [OR] = 0.745 [0.565–0.981], p=0.0363), catalase (OR = 0.950 [0.915–0.98], p=0.0076), as well as high creatinine levels (OR = 1.071 [1.002–1.144], p=0.0422) were risk factors for death during 1.5 year follow-up. Conclusions Coronary sinus lower ceruloplasmin and catalase levels, as well as higher creatinine level are independently associated with death during 1.5 year follow-up. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Medical University of SIlesia, Katowice, POland

scholarly journals Taxonomic signatures of cause-specific mortality risk in human gut microbiome

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Aaro Salosensaari ◽  
Ville Laitinen ◽  
Aki S. Havulinna ◽  
Guillaume Meric ◽  
Susan Cheng ◽  
...  
Keyword(s):  
Mortality Risk ◽  
Gut Microbiome ◽  
Human Gut ◽  
Cross Sectional ◽  
Microbiome Composition ◽  
Human Gut Microbiome ◽  
Non Invasive ◽  
Sequencing Technologies

AbstractThe collection of fecal material and developments in sequencing technologies have enabled standardised and non-invasive gut microbiome profiling. Microbiome composition from several large cohorts have been cross-sectionally linked to various lifestyle factors and diseases. In spite of these advances, prospective associations between microbiome composition and health have remained uncharacterised due to the lack of sufficiently large and representative population cohorts with comprehensive follow-up data. Here, we analyse the long-term association between gut microbiome variation and mortality in a well-phenotyped and representative population cohort from Finland (n = 7211). We report robust taxonomic and functional microbiome signatures related to the Enterobacteriaceae family that are associated with mortality risk during a 15-year follow-up. Our results extend previous cross-sectional studies, and help to establish the basis for examining long-term associations between human gut microbiome composition, incident outcomes, and general health status.

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