bluuebunny/crossref_metadata_2025 huggingface dataset:
Temporal trend of clinical events in patients with atrial fibrillation on edoxaban therapy: results from the non-interventional global ETNA-AF program
Authors: Dinshaw L , Chen C , De Caterina R , Jiang W , Kim Y.-H , Koretsune Y , Morrone D , Pecen L , Reimitz P.-E , Wang C.-C , Yamashita T , Unverdorben M , Kirchhof P
Published: October 2021

Background

Patients with atrial fibrillation (AF) who initiated vitamin K antagonist (VKA) were at highest risk of stroke and bleeding in the first few months of therapy. Understanding of the temporal trend of clinical events in AF patients on non-VKA oral anticoagulant (NOAC) therapy should aid therapeutic decisions.

Purpose

To evaluate the temporal trend of clinical events in AF patients receiving edoxaban in routine clinical practice in the Global ETNA-AF program.

Methods

Global ETNA-AF is a multicentre, prospective, noninterventional program evaluating the safety and effectiveness of edoxaban in patients from European and Asian countries. Thromboembolic, bleeding and death events were analysed separately for the 1st and 2nd year of the follow-up period, using a time-to-first-event estimation of cumulative incidence and annual rate via Kaplan-Meier method.

Results

A total of 27,617 patients were included in this analysis, 48.6% from Europe and 51.4% from Japan, Korea, and Taiwan. Baseline characteristics were consistent with typical AF population in real world studies (Table 1). Approximately 83% of patients received the recommended edoxaban dose. Annualized rates of ischaemic stroke and major bleeding (ISTH) were lower in the 2nd year than in the 1st year: ischaemic stroke 0.59% (95% CI, 0.50–0.70) vs 0.86% (95% CI, 0.75–0.98), p=0.015; major bleeding 0.87% (95% CI, 0.75–1.00) vs 1.15% (95% CI, 1.02–1.29), p=0.036. The trend toward lower rates of ischaemic stroke and major bleeding in the 2nd year was consistent across regions. All-cause mortality increased slightly from the 1st year to the 2nd year, which was not statistically significant and was not driven by cardiovascular (CV) mortality (Table 2).

Conclusion

In routine clinical practice in the Global ETNA-AF program, major bleeding and ischaemic stroke rates in >27,000 patients on edoxaban therapy declined from 1st year to 2nd year. Further analyses will investigate whether such trend is influenced by selection for healthier patients over time. Longer follow-up is needed to better understand long-term trends.

Funding Acknowledgement

Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Table 1. Baseline characteristicsTable 2. Annualised clinical event rates
Evaluating direct oral anticoagulants versus vitamin K antagonists for treatment of left ventricular thrombus: a systematic review and meta-analysis
Authors: Qiu Y , McEwen C , Bhagirath V , Chan N , Eikelboom J , Eikelboom R , Young J , Whitlock R , Belley-Cote E
Published: October 2021

Background/Introduction

Left ventricular thrombi are associated with high rates of stroke and systemic embolism (1). While vitamin K antagonists (VKAs) have historically been the anticoagulant of choice, they have a narrow therapeutic window and require frequent monitoring. Direct oral anticoagulants (DOACs) offer more predictable anticoagulation but the use of DOACs to treat left ventricular thrombus has not been well studied (1,2). Guideline recommendations around the topic are based on expert consensus and very low-quality evidence.

Purpose

This systematic review and meta-analysis compares DOACs or VKAs in the treatment of left ventricular thrombus. Outcomes of interest were stroke and systemic embolism, thrombus resolution, any bleeding, major bleeding, and mortality.

Methods

We searched CENTRAL, MEDLINE, EMBASE, CINAHL, ACPJC, and Web of Science for studies comparing DOACs and VKAs in the treatment of left ventricular thrombus. We also searched reference lists from included studies and relevant conferences' proceedings. Two reviewers independently screened titles and abstracts and then the full-text of potentially relevant citations in duplicate. They then extracted data and evaluated risk of bias in duplicate. The data was analyzed using Revman 5.3. We used the DerSimonian and Laird random-effects model to pool the weighted effect of estimates across all studies. The pooled relative risks (RRs) were calculated with corresponding 95% confidence intervals (CIs). We assessed the quality of evidence for each outcome using the Grading of Recommendations, Assessment, Development, and Evaluation approach.

Results

Of 443 citations screened, 12 observational studies (n=2,225) were included. We found no randomized controlled trial addressing the question. Most included studies were at high risk of bias due to unmatched baseline variables. We found no significant difference in any of our outcomes with DOACs versus VKAs: stroke and systemic embolism (RR 1.14, 95% CI [0.82, 1.58], p=0.43), thrombus resolution (RR 1.02, 95% CI [0.91, 1.15], p=0.69), any bleeding (RR 1.47, 95% CI [0.65, 3.33], p=0.36), major bleeding (RR 0.22, 95% CI [0.01, 4.21], p=0.32), and mortality (RR 0.99, 95% CI [0.67, 1.45], p=0.95). Evidence for each of these outcomes was of very low-quality due to risk of bias, inconsistency, and imprecision of the studies.

Conclusions

Very low quality evidence suggests no difference in outcomes with DOACs versus VKAs in the treatment of left ventricular thrombus. More robust data are needed to guide clinicians.

Funding Acknowledgement

Type of funding sources: None.
Effectiveness of direct oral anticoagulants in obese adults with atrial fibrillation: an overview examining the evidence from international systematic reviews and meta-analyses
Authors: Shaikh F , Wynne R , Castelino R L , Inglis S C , Ferguson C
Published: October 2021

Background

Obesity may influence the pharmacology of direct oral anticoagulants (DOAC) that are recommended by all international guidelines for stroke prevention in adults with atrial fibrillation (AF).

Purpose

To evaluate the safety and efficacy of DOACs in obese adults with AF.

Methods

Medline, CINAHL, Scopus, Web of Science, Cochrane Database, Johanna Briggs Institute, Embase, Psych Info and ProQuest were searched till April 2020. Only systematic reviews with meta-analyses, that were published after 2005 and were in the English language were included. Articles were screened by title and abstract, followed by full text assessment using the Covidence systematic review software. Data was extracted using a standardised extraction tool. AMSTAR-2® and ROBIS® tools were used for quality and risk of bias assessment. The entire process was undertaken by two investigators at each stage of the study selection, appraisal, and data extraction. Disagreements were resolved through consensus discussion with a third arbitrary investigator. Statistical analyses were performed using the DerSimonian and Laird method for random effects. Meta-analysis was performed using only randomised controlled trials from eligible systematic reviews at both 12 months and across the entire trial. Primary outcomes assessed was stroke (ischemic or haemorrhagic) or systemic or pulmonary embolism. Secondary outcomes assessed included all-cause mortality, transient ischemic attack, myocardial infarction, major bleed, all cause-hospitalisation, and cardiovascular mortality.

Results

Of the 8162 articles screened, a total of five systematic reviews were included in this overview. There was disagreement within the published reviews on the effect of DOAC in obesity. Four of the five reviews were of either “low” or “critically low” quality, with inconsistencies in data extraction and appropriateness of the included studies and statistical methods used in analysis. Data from only the RE-LY, AVERROES and ENGAGE AF-TIMI 48 trials, were available for the meta-analysis, which did not find any significant difference between all BMI groups for all outcomes, at both time points. However, analysis of the different weight groups versus normal weight, highlighted non-significant differences between the different DOACs.

Conclusion

There was no difference between the BMI classes in any of the outcomes assessed. However, the non-significant trends that were seen, suggests individual superiority of DOACs may exist within the obese adult populations. There is a need for prospective trials to evaluate which DOACs are safe and efficacious in the obese class III adults and at which dose.

Funding Acknowledgement

Type of funding sources: Other. Main funding source(s): Australian Government Research Training Program (RTP) Heart Foundation of AustraliaNational Health and Medical Research Council (NHMRC)
Dual antiplatelet therapy with 3rd generation P2Y12 inhibitors in STEMI patients: impact of Body Mass Index on high on-treatment platelet reactivity
Authors: Scudiero F , Canonico M E , Sanna G D , Saba P G , Esposito G , Parodi G
Published: October 2021

Background

High on-treatment platelet reactivity (HTPR) has been associated with high risk of ischemic events in STEMI patients. Body mass index (BMI) and specifically overweight and obesity are risk factors for increased platelet reactivity in different series of patients, however data regarding their relationship with pharmacodynamic response to oral 3rd generation P2Y12 inhibitors is still lacking.

Purpose

This study aims to assess the association between BMI and HTPR in STEMI patients treated with oral 3rd generation P2Y12 inhibitors.

Methods

Overall, 429 STEMI were enrolled in this study. Patients were divided into two groups according to BMI (BMI <25; BMI ≥25). A propensity score matching (1:1) was performed to balance potential confounders in baseline study characteristics. Platelet reactivity was assessed by VerifyNow at baseline and after 3rd generation P2Y12 inhibitor (ticagrelor or prasugrel) loading dose (LD). Blood samples were obtained at baseline (T0), 1 hour (T1), 2 hours (T2), 4–6 hours (T3) and 8–12 hours (T4) after the LD. HTPR was defined with a platelet reactivity unit values ≥208 units.

Results

The mean age of the enrolled population was 62±12 and male rate was 75%. Patients with a BMI ≥25 were younger (61±12 Vs 64±11, p=0.006), with a higher prevalence of male gender (78% vs 68%, p=0.035), and hypertension (56% vs 46%, p=0.072), and they were less frequently treated with pre-PCI mophine use (30% Vs 42%; p=0.018). After propensity score matching (Table), patients with BMI ≥25 had similar values of baseline platelet reactivity [T0: 308 (285–342) vs 300 (281–330), p=0.396), while they had higher level of platelet reactivity at 1 and 2 hours after the LD [T1: 285 (200–308) vs 265 (196–320), p=0.047); T2: 241 (87–305) vs 200 (56–256), p=0.004)] and higher rate of HRPT [T1: (66% vs 47%, p=0.004); T2: (40% vs 24%, p=0.006)]. Furthermore, multivariable analysis demonstrated that BMI ≥25 was an independent predictor of HTPR at 2h (OR 2.01, 95% CI 1.18–3.42; p=0.009). Conversely, starting from 4 hour after the LD, platelet reactivity values [T3: 68 (7–173) vs 15 (6–71), p=0.76); T4: 38 (4–104) vs 44 (4–82), p=0.958)] and HRPT rates (T3: 13% vs 10%, p=0.595; T4: 1% vs 1%, p=0.320) were comparable among the study groups.

Conclusions

A BMI ≥25 is associated with decelerated pharmacodynamic response to oral 3rd generation P2Y12 inhibitors LD and resulted a strong predictor of HRPT in STEMI patients treated by dual antiplatelet therapy with ticagrelor or prasugrel.

Funding Acknowledgement

Type of funding sources: None. Table, panel ATable, panel B
Efficacy and safety of early aspirin withdrawal and continuation of ticagrelor monotherapy post PCI for STEMI. A post hoc analysis of the randomized global leaders trial
Authors: Gamal Setih A , Hara H , Tomaniak M , Lunardi M , Gao C , Ono M , Kawashima H , Juni P , Vranckx P , Windecker S , Hamm C , Gabriel Steg P , Onuma Y , Serruys P ,   Global Leaders Trial Investigators
Published: October 2021

Background

Clinical presentation with STEMI is considered as a highly prothrombotic condition often associated with recurrent ischemic events. The role of aspirin as part of antiplatelet regimens in STEMI patients needs to be clarified especially in the context of new potent P2Y12 inhibitors

Aim

To assess the benefit and risk of 23-month ticagrelor monotherapy after one month of DAPT against the conventional 12-month DAPT with aspirin and ticagrelor followed by aspirin monotherapy among STEMI patients in the GLOBAL LEADERS trial.

Methods

We did a post hoc analysis of STEMI patients in the GLOBAL LEADERS trial (2092 patients). We compared the experimental ticagrelor monotherapy group (1062 patients) with the standard 12-month DAPT group (1030 patients) in rates of GLOBAL LEADERS predefined primary (composite of all-cause mortality or non-fatal, new Q-wave myocardial infarction (MI) and secondary end points (BARC 3 or 5 bleeding). NACE (Net Adverse Clinical Events) and POCE (Patient- Oriented Composite End points). We also compared GLOBAL LEADERS predefined end points in STEMI, UA, NSTEMI and CCS in both treatment arms.

Results

At two years, there were no significant differences in rates of GLOBAL LEADERS primary end points in patients who had or did not have STEMI. BARC bleeding in either treatment group didn't vary significantly among STEMI, NSTEMI and UA. Nevertheless, the experimental strategy had led to significant increase in BARC bleeding in CCS compared with STEMI at 1 and 2 years. There were similar rates of NACE and POCE in both the experimental and reference treatment groups at 1 and 2 years post PCI.

Conclusions and relevance

The incidence of GLOBAL LEADRER defined end points has not been impacted by STEMI presentation. Our findings suggest that an earlier cessation of DAPT at 1 month post primary PCI, with continuation of a potent P2Y12 antagonist monotherapy, could be safe and avoids additional bleeding risk in the STEMI setting. Given the post-hoc nature of the analysis, our findings should not necessitate changes in recommendations for practice by professional associations and regulatory agencies. However, all reported findings should rather be considered only as hypothesis-generating and need be replicated in dedicated large-scale randomized trials to further assess the role of Aspirin free antithrombotic strategies post PCI in STEMI.

Funding Acknowledgement

Type of funding sources: None.
Inorganic nitrate attenuates endothelial dysfunction consequent to systemic inflammation
Authors: Lau C , Shabbir A , Rathod K S , Chhetri I , Ono M , Hamers A J P , Amarin J J , Ibrahim A , Nuredini G , Godec T , Kapil V , Ahluwalia A
Published: October 2021

Introduction

Chronic cardiovascular diseases are characterised by low-grade systemic inflammation and attenuated nitric oxide (NO) bioavailability resulting in endothelial dysfunction. Inorganic nitrate augments NO bioavailability and improves markers of vascular dysfunction in patients with cardiovascular risk factors. However, the exact mechanism of this effect is uncertain.

Purpose

To determine whether inorganic nitrate supplementation alters systemic inflammation-induced endothelial dysfunction.

Methods

62 healthy male volunteers were randomised 1:1 to receive ∼8–10 mmol of dietary inorganic nitrate in beetroot juice or nitrate-free beetroot juice (placebo) once daily for 6 days. Measures of brachial artery flow-mediated dilatation (FMD), brachial blood pressure (BP), pulse wave analysis and carotid-femoral pulse wave velocity (PWV) by Vicorder were taken prior to and at 8 hours after a typhoid vaccine (to induce mild systemic inflammation). Plasma, urine and saliva samples were also collected. Clinicaltrials.gov: NCT02715635.

Results

Baseline characteristics were similar between the two groups. Inorganic nitrate significantly elevated plasma nitrite (placebo = Δ0.02±0.5 μM, inorganic nitrate = Δ0.63±1.2 μM; p=0.01) and nitrate levels (p<0.0001) compared to placebo. There were significant increases in urine nitrite (p<0.0001) and nitrate (p<0.0001) in addition to salivary nitrite (p<0.0001) and nitrate (p<0.0001) compared to placebo. After 8 hours, typhoid vaccine induced an increase in circulating white cells (placebo = Δ3.34±3.37x109/L, inorganic nitrate = Δ2.9±2.78x109/L; p=0.58) that was similar in in both arms. However, there was a significant reduction in the FMD response in the placebo group at 8-hours post vaccine; an effect that was absent in volunteers treated with inorganic nitrate (placebo = Δ−1.33±1.53%, inorganic nitrate = Δ−0.07±1.84%, p=0.005). Importantly, there were no statistically significant differences in baseline vessel diameter (p=0.78), time to peak diameter in response to flow (p=0.87) and peak shear rate (p=0.57) between the groups. When comparing change from baseline to 8 hours after the vaccine, there were no significant differences in brachial systolic BP (p=0.12), central systolic BP (p=0.12) and PWV (p=0.60) between groups, but a significant reduction in brachial diastolic BP in the inorganic nitrate group (p=0.048).

Conclusions

Inflammation-induced endothelial dysfunction was prevented in those receiving dietary inorganic nitrate suggesting that elevating circulating nitrite and delivering NO to the blood vessel wall, through dietary approaches may offer potential therapeutic benefit in those cardiovascular diseases which typically exhibit low grade inflammation and deficiencies in bioavailable NO.

Funding Acknowledgement

Type of funding sources: Public Institution(s). Main funding source(s): British Heart Foundation
Linking salt preference to enjoyment of low sodium diet in patients with heart failure
Authors: Chung M L , Lennie T A , Miller J L , Moser D K
Published: October 2021

Background

Preference for salty foods is linked to dietary sodium intake. Increased salt preference is a barrier to low sodium diet (LSD) adherence due to perceived poor taste. Although patients with heart failure (HF) are advised to follow a LSD, the adherence remains poor. Understanding the relationship among attitudes, subjective norms (individuals' beliefs about how much they follow the advice of respected others), and perceived control for following a LSD, salt preference, and LSD enjoyment will help in designing interventions to increase adherence in patients with HF.

Purpose

The purpose of this study was to examine whether attitudes toward following a LSD, subjective norms about LSD, and perceived behavioral control for following a LSD mediated the association between salt preference and enjoyment of a LSD in patients with HF.

Methods

In this cross-sectional study, outpatients with HF completed the Dietary Sodium Restriction Questionnaire (DSRQ) based on the Theory of Planned Behavior, and rated salt preference and enjoyment of a LSD on a scale from 0 to 10 with 10 indicating the highest salt preference and enjoyment of LSD. Parallel mediation analyses were conducted using the PROCESS macro program in SPSS with 5,000 bootstrap samples controlling for age and gender. Three subscales of the DSRQ (i.e., attitude, subjective norms, and perceived behavioral control) were used as mediators.

Results

A sample of 117 patients with HF (65% male, mean age = 61.2±14.3, range 27 to 94, 82% white) completed the study. The mean salt preference rating was 5.26 (SD=2.7), and the LSD enjoyment rating was 4.56 (SD=2.5). Salt preference was not directly associated with LSD enjoyment (direct effect = −0.0506, 95% CI: [−0.2394, 0.1381]). There was a significant indirect effect of salt preference on the enjoyment of LSD through perceived behavioral control (indirect effect = −0.1178, 95% CI: [−0.0321, 0.0446]) (Figure 1). Patients with a high salt preference were more likely to have low levels of LSD enjoyment through the mediator of having low levels of perceived behavioral control over following a LSD. Subjective norms and attitudes toward LSD were not significant mediators of the association between salt preference and LSD enjoyment.

Conclusion

High preference for salty food decreased perceived behavioral control of LSD, which reduced enjoyment of LSD in patients with HF. Salt preference and perceived behavioral control in LSD are behavioral barriers in hedonic shift in LSD enjoyment. The findings suggest that intervention to promote LSD adherence should include strategies to increase perceived behavioral control in eating LSD and decreasing salt preference.

Funding Acknowledgement

Type of funding sources: Public grant(s) – National budget only. Main funding source(s): National Institutes of Health in the USA
A telephonic cardiology advice line was effective during the COVID-19 pandemic in both reassuring patients and in ensuring patients received optimal urgent care
Authors: Devlin J , Peace A J , McGlinchey P G
Published: October 2021

A decrease in patients accessing health care was documented during the first COVID-19 surge.

We established a 24/7 cardiology telephone advice service during the first surge, this was provided by an experienced cardiology nurse based in a nurse-led cardiac assessment unit. Various options were available on the basis of the telephone consultation. We particularly wanted to see the outcomes of reassurance of patients (to see if the approach was safe) and the outcomes of patients who were directed to emergency departments (to see if this identified patients with significant cardiological and medical problems who may not otherwise have accessed healthcare).

We reviewed the progress of the first 999 patients who used the telephonic service for which we had 90 day follow-up data.

141 patients were initially reassured by the nurse at the telephone call. Of these, 55 patients had no further engagement with healthcare providers in the subsequent 90 days. 7 were followed-up within the cardiac rehabilitation program that they were already participating in. 21 were referred to cardiology by their GP but all subsequently had normal assessment and/or investigation. 30 attended an emergency department of whom 22 were discharged directly from the ED; the other 8 patients were admitted to hospital which included 2 patients with non-cardiac chest pain and 2 with exacerbations of known heart failure. 28 patients recontacted the telephonic service during the 90 days and had subsequent face-to-face assessment. There was one death amongst the 141 patients, from a known malignancy.

161 patients were advised to attend an emergency department following telephonic evaluation of whom 50 did not attend. 84 patients were discharged home following assessment in the emergency department of whom 18 were discussed or referred to cardiology for outpatient assessment. 20 patients were admitted under cardiology (8 non-STEMI, 1 complete heart block, 1 profound bradycardia, 1 atrial fibrillation, 1 congestive cardiac failure, 1 critical aortic stenosis, 1 chemotherapy associated cardiotoxicity, 4 no significant cardiac issue found). Nine patients were admitted to non-cardiac wards.

We believe that nurse-led telephonic triage can be effective in the management of patients in the community with established cardiac disease or with potential cardiac symptoms. We intend to further develop the service we established during the first surge of the COIVD-19 pandemic.

Funding Acknowledgement

Type of funding sources: None.
The feasibility of algorithm-based ECG interpretation in remote monitoring – 53,748 recordings from the Dutch HartWacht program
Authors: Blok S , Slaats B M I , Somsen G A , Tulevski I I , Hofstra L , Winter M M
Published: October 2021

Background

Symptom driven remote monitoring programs for cardiac arrhythmias hold great promise, but scalability is limited due to high additional workload for healthcare providers. The Dutch HartWacht arrhythmia program consists of a connected single lead ECG device operated remotely by the patient, an algorithm for classification and a dedicated team of specialized nurses and cardiologists for additional remote interpretation. Correct classification as sinus rhythm (SR) by the algorithm would reduce workload of the HartWacht team, as it makes double-checking redundant.

Purpose

We investigated agreement of the ECG-classification between the algorithm and the HartWacht team and determined feasibility of the algorithm to classify sinus rhythm (SR).

Methods

We investigated the algorithm accompanying a single lead, handheld ECG-device that is integrated in the Dutch HartWacht program. We retrospectively studied the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the algorithm for classifying SR on home measured 30-second single lead ECGs. We included all recordings that were classified as SR by the algorithm. We used the classification of the HartWacht team as a reference standard.

Results

Between April 2020 and January 2021, 1,671 patients with (suspected) arrhythmias (female = 982 (59%), mean age = 58 (±15) years, participating in the HartWacht program, recorded 53,748 ECGs, of which the algorithm interpreted 35,388 (66%) as SR, 10,899 (20%) as possible AF and 7,461 (14%) as other. All recordings were also interpreted by the HartWacht team. Compared to the classification by the team, the algorithm showed a sensitivity for SR of 0.953, specificity of 0.985, PPV of 0.996 and NPV of 0.841. A total of 137 (0,3%) ECGs from 50 (2,8%) patients showed false positive outcomes, classifying recordings as SR while the HartWacht team detected arrhythmias. In 42 of those patients, arrhythmias were detected by the algorithm in other recordings within the program. The remaining 8 (0,5%) patients made a total of 14 (<0,1%) recordings with false positive outcomes without having any other recordings with arrhythmias within the HartWacht program.

Conclusion

For classifying SR in home measured single lead ECGs, the algorithm and the HartWacht team showed a nearly perfect agreement. The recordings without agreement did not lead to relevant individual changes in diagnostic or therapeutic strategy for the patient. Therefore, the algorithm is feasible as standalone classification. With 66% of the recordings within the HartWacht program showing SR, a corresponding workload reduction can be achieved which importantly increases scalability and cost-effectiveness of remote monitoring of arrhythmia patients.

Funding Acknowledgement

Type of funding sources: None.
Telerobotic interventions from a distance: an initial experience in 3D phantom mapping
Authors: Ailoaei S , Wright P , Griffiths S , Jansen M , Ernst S
Published: October 2021

Introduction

The current COVID-19 pandemic has fostered several accelerations in “remote” patient care such as video and telephone clinics, as well as multidisciplinary collaborations using online platforms with experts consulting the local teams from a distance. The next logical step would be to also offer remote-controlled interventions which the expert operator not on site, but in support of the local team. This is especially valuable for complex interventions when either patient or expert operator can not be present at the same place.

Purpose

We aimed to demonstrate that an expert operator located at far distance (Austria) could directly interact with the remote magnetic navigation system in London (UK) whilst mapping a 3D phantom using an electroanatomical mapping system.

Method

Two experienced operators of the magnetic navigation system were tasked with creating fast anatomic maps (FAM) of the atrial and ventricular chambers of a 3D phantom using remote magnetic navigation in combination with 3D electroanatomical mapping. One was located in the control room of the magnetic catheter lab (UK) and the second one was in Tirol, Austria and connected through a secure remote desktop connection (via high speed fibre optic cable). Using a solid tip magnetic catheter connected to a mechanical drive, all interactions with the system were carried out via the Odyssey platform. Acquisitions for right and left atrium, as well as right and left ventricles plus aorta was compared with regards to mapping duration, map completeness (as judged by the average distance of surface points from 3D CT scan reconstruction), total 3D map volume and need for additional radiation exposure during the mapping process.

Results

Mapping time and map completeness when performed by the distant operator was not inferior to the local operator and both did not require any additional radiation exposure during the mapping process. Table 1 demonstrates the mean parameters for each chamber, respectively. Figure 1 depicts the matched data for chamber completeness as compared for the LA (green= local operator, pink= distant operator) using a contrast CT scan as the gold standard.

Conclusion

Telerobotic 3D mapping of a 3D phantom from a distance was equally fast delivered from the control room as compared to an operator located 1200 km away without compromising on map completeness. This demonstrates the feasibility of telerobotic interventions and stress the need for remote collaboration which is especially valuable when travel of patients and/or physician experts is restricted.

Funding Acknowledgement

Type of funding sources: None. Matched data for aorta
Home monitoring program for patients following cardiac surgery
Authors: Sokolskaya M , Shvartz V A , Bockeria O L , Bockeria L A
Published: October 2021

Patient compliance with medical recommendations and monitoring of the cardiovascular system parameters after discharge from the hospital are important in the postoperative period.

Material and methods

The program of remote home monitoring of patients after cardiac surgery was created and is used in clinical practice of the department of surgical treatment of interactive pathology. First of all, we analyzed the capabilities of apps for mobile phones, ECG monitoring devices, and blood pressure monitors with the ability to remotely reset data via Bluetooth which are available in Russia. In accordance with the requirements of the high-tech clinic, the following applications were selected: MediSafe (control of drug therapy), MedMBP (control of blood pressure), Ritmer (ECG monitoring), MiFit (a step tracker). In the follow-up program 25 patients (15 men, 10 women) were included. The average age is 59±11 years (min-29, max-91). Performed interventions: 7 patients underwent RFA, 6-valve replacement with a mechanical prosthesis, 2-valve replacement with a bioprosthesis, 7-CABG, 5-PCI. The patients gave their voluntary consent to participation, confirmed their readiness and ability to use apps and devices. The initial psychological status and the quality of life were assessed using the SF 36 and HADS questionnaires. All patients were given a tonometer for BP measuring, an ECG device and a step tracker to evaluate physical activity. According to the protocol, patients measure BP and ECG daily or additionally if they feel worse; using the mobile app, they note the taken medications. All data are sent to the server and analysis by the doctor. The doctor reviews the received indicators every day and, if necessary, contacts the patient to discuss treatment tactics.

Results

For today the follow-up period is 3 months. During this period, 96% of patients strictly follow the program protocol. One patient has difficulties when using the ECG recorder, does not regularly follow the recommendations for drug therapy, which requires an individual approach. Based on the monitoring results, correction of antihypertensive therapy was necessary in 40% of cases, antiarrhythmic therapy-in 20%. In one case, a sinus node weakness syndrome was detected, and the patient was called to the hospital for the pacemaker implantation.

Conclusion

The remote monitoring program is an effective and promising tool for monitoring patients after discharge from the hospital. It is clear that the results obtained from more patients and after a longer follow-up period would be more informative. However, the intermediate initial result indicates the necessity and effectiveness of this program.

Funding Acknowledgement

Type of funding sources: None. Figure 1
The use of telemedicine in cardiogenetics clinical practice during the COVID-19 pandemic
Authors: Liang L , Kalia I , Latif F , Waase M P , Sayer G , Reilly M P , Uriel N
Published: October 2021

Background

The coronavirus disease 2019 (COVID-19) pandemic has necessitated the widespread adoption of telemedicine, and while many clinics have now re-established in-person patient visits, telemedicine is likely to continue to play an important role in health care delivery. In particular, the embrace of telemedicine presents an unprecedented opportunity through which to expand the reach of genetic counseling, i.e., telegenetics.

Purpose

The aim of this study was to examine the impact of COVID-19 on genetic counseling practices within the cardiogenetics clinics at a large academic center in New York City.

Methods

We retrospectively analyzed clinical characteristics of patients who were seen for cardiovascular genetic counseling visits pre-pandemic between April 1, 2019 through December 23, 2019 and during the pandemic between April 1, 2020 through December 23, 2020 at Columbia University Irving Medical Center. Genetic testing results were recorded for each encounter when available.

Results

Overall, 104 patients had a cardiovascular genetic counseling visit in 2019 compared to 132 patients in 2020 (Table). Only 6% (n=6) of visits in 2019 were remote telemedicine encounters whereas 80% (n=106) of visits in 2020 were telemedicine encounters. There was a significant increase in the number of family members seen for genetic counseling in 2020; in 2019 only 15% (n=16) of the patients seen for genetic counseling were family members of probands whereas this percentage increased to 34% in 2020 (n=45; p=0.002). In addition, in 2020 the geographic reach of genetic counseling extended far beyond New York state, reaching a total of 11 states as well as one patient in Puerto Rico (Figure). Genetic testing results were similar between the two years with 29% of patients found to be genotype positive in 2019 and 29% of patients genotype positive in 2020 (p=0.91). Notably, of those patients who underwent telemedicine visits and were sent genetic testing kits (n=106), 14% (n=15) did not return a sample.

Conclusions

In this study we found that despite the health care delivery barriers created by the COVID-19 pandemic, the use of telemedicine allowed us to not only continue seeing patients for cardiovascular genetic counseling visits but also to expand the reach of genetic counseling and testing beyond the geographical boundaries of our previous catchment area. Telegenetics offers patients and clinicians convenience and flexibility and has likely earned its permanent place in clinical practice. Future efforts are warranted to study the longer-term clinical impacts of telegenetics as well as to continue to improve telemedicine technology, with the ultimate aim of increasing patient access to personalized genomic medicine.

Funding Acknowledgement

Type of funding sources: None.
Patients' perspectives on iatrogenic risk and therapeutic adherence of their cardiovascular therapies: a real-life survey
Authors: Mourad J J , Chekroun M , Pellet A F , Pecout C
Published: October 2021

Background

Cardiovascular disease, one of the main Non-Communicable Disease (NCD), is the first cause of death in the world representing 30% of global mortality. Their prevention, early detection, reduction of risk and progression are major daily challenges. Success depends on patient adherence which is the most enigmatic and difficult challenge for the physician to assess. Our objective was to better understand Patients' Experience, including their behavior and knowledge of the risks and benefits of their treatment, as well as their perception of therapeutic adherence and iatrogenic risk.

Purpose

This real-world study conducted on patients affected by cardiovascular diseases, identified their views on iatrogenic risk and compliance with their condition and treatment intake.

Method

An online survey was conducted on the Carenity platform among adult patients affected by cardiovascular disease (CV) between February 14th and May 15th, 2020. A multiple correspondence analysis (MCA) was performed on a dataset of French patients with CV disease using a hierarchical cluster analysis.

Results

403 patients (women 54%) mean age 60,6 YO with High Blood Pressure (56,6%), diabetes (28,3%), heart attack (26%), hypercholesterolemia (22%), arrythmia (19,6%), stroke (14%). Mean number of medications per day was 5,1 and 6,1 of pills. 3 groups of patients were identified as per MCA.

The group 1 “at risk” (n=168) concerns the least compliant patients, mostly women. They visit more often their doctor (83%), whom they are afraid to disappoint. 46% deliberately deviate from initial prescription even if they feel compliant (73%). They consider they are less likely to have received explanation on treatment benefits (73%). They seem to be more worried about incompatibility with daily life (33%) and frequency of administration (40%). 34% are more likely to be afraid of becoming dependent and 49% lacking efficacy. 76% discuss about constraints and risks with someone. The group 2 “tolerant” (n=90) includes patients less aware with interactions with other treatments (73%) and with alcohol (64%). They do not think it is necessary to inform their doctor about compliance issues (76%).

The group 3 “reporters” (n=145) concerns patients, mostly men, who feel more compliant (90%) than others. They feel informed (84%), they use practical solutions to be compliant (63%) and they are aware of treatment interactions such as tobacco (37%).

Conclusion

These results from the Patient Experience, suggest new patient behaviors and profiles. They focus on coping mechanisms and solutions they develop to manage their relationship with treatment. These identified profiles should be included in the Therapeutic Patient Education approach. The objective is to improve overall management by increasing compliance and reducing the iatrogenesis risk.

Funding Acknowledgement

Type of funding sources: Private company. Main funding source(s): Pfizer PFE France, a Viatris company
Racial/ethnic differences in cardiovascular outcomes in a universal healthcare system: insights from the CARTaGENE cohort
Authors: D'Entremont M , Couture E L , Nguyen M , Ni J , Yan A , Ko D , Abhinav S , Goodman S , Huynh T
Published: October 2021

Background

While prior studies have shown racial/ethnic differences in cardiovascular (CV) outcomes within private or mixed health care systems, it remains uncertain whether inequalities in cardiovascular outcomes exist between different races and ethnicities in universal health care contexts. We aimed to determine whether there are racial/ethnicity disparities in long-term CV outcomes within a single-payer universal health care system.

Methods

The CARTaGENE study is a population-based prospective cohort study with enrollment of 19,996 individuals between 40–69 years in 2009, in the province of Quebec, Canada. Participants residing in four large metropolitan areas were randomly chosen from the provincial health insurance registry by strata of age, sex, and postal codes. Follow-up was available up to 2016. For this analysis, we retained only participants without prior known CV disease. The primary composite endpoint was time to the first CV event or intervention (CV death, acute coronary syndrome, heart failure, coronary revascularization, ischemic stroke, or peripheral vascular event or revascularization). We used unadjusted and adjusted Cox proportional hazard models to evaluate the association of self-defined race/ethnicity with the primary endpoint.

Results

There were 17,802 eligible participants with a mean age of 51 years (52.5% females) with 111,312 person-years of follow-up (median follow-up of 6.6 years). South Asian (SA) participants had the highest prevalence of diabetes mellitus (29%) and hypertension (32%). After adjustment for age and sex, SA ethnicity was associated with a 95% relative increase in risk for CV events, while East/Southeast Asian (ESA) ethnicity was associated with a 42% relative decrease in risk for CV events compared to White participants. After further adjustment for socioeconomic status and CV risk factors, ESA ethnicity remained associated with a similar decreased CV risk. In contrast, the association of SA ethnicity with increased CV risk was attenuated after full adjustment for baseline characteristics (Table 1).

Conclusions

Racial/ethnic disparities in long-term CV outcomes are present in a single-payer universal healthcare setting. ESA ethnicity was associated with a lower risk of long-term CV outcomes. Future studies are needed to corroborate the reduced risk of long-term major CV events associated with ESA ethnicity. Understanding the reasons related to potential CV protection with ESA ethnicity could facilitate endeavors to reduce long-term CV outcomes in other races/ethnicities.

Funding Acknowledgement

Type of funding sources: Public hospital(s). Main funding source(s): McGill Health University Center
The impact of clinical skills training on hospital nursing care towards acquisition of improved care quality: a systematised review
Authors: Calmita H J C , Boag B R
Published: October 2021

Aim

The study aim is to review the literature regarding the impact of clinical skills training on the quality of care delivery in the hospital setting.

Objectives

Design

A systematised review which summarises the multiple studies retrieved utilising systematic manner of searching. Mixed studies of the qualitative and quantitative study were compiled and analysed using a combined qualitative analysis and qualitative narrative synthesis.

Data sources

Six databases were searched. Academic Search Premier, CINAHL, Cochrane Library, Pubmed, ScienceDirect, and Wiley Online Library. Key journals were hand searched from the university library, reference tracking was done, and grey literature was checked. Lastly, the professional support of the department librarian was sought during the initial stage of the finding of evidence.

Results

From a total of 1,023 articles that were initially found, a total of ten studies were included for the review. It included two quasi-experimental studies, five qualitative methods, and three observational studies (2 cross-sectional and 1 cohort), that evaluated the impact of clinical skills training to nursing practice or care quality, or both. All articles were then critically appraised using the appraisal tool developed by Long and Godfrey (2004).

Conclusions

Continuing staff development is seen as beneficial in order to adapt to the rapid changes in healthcare delivery services. Developing an educational assessment tool addressed towards the evaluation of clinical based teaching should be given fundamental focus as it can define and evaluate the impact of knowledge transfer upon completion of a training course. Further research that addresses the impact of nursing training to clinical practice, specifically addressed to the low-income health care organisations is recommended.

Funding Acknowledgement

Type of funding sources: None.
Is HNF4A gene, a risk factor or protection against coronary artery disease?
Authors: Temtem M , Serrao M , Mendonca M I , Santos M , Sousa A , Mendonca F , Sousa A C , Henriques E , Freitas S , Rodrigues M , Borges S , Guerra G , Drumond A , Palma Dos Reis R ,   GENEMACOR study
Published: October 2021

Background

Hepatocyte nuclear factor4 A (HNF4A) gene was considered by GWAS associated with atherosclerosis and CAD susceptibility. Loss-of-function mutations in human hepatocyte nuclear factor 4α (HNF4α), a transcriptor factor encoded by the HNF4A gene, are associated with maturity-onset diabetes of the young and lipid disorders. However, the mechanisms underlying the lipid disorders are poorly understood.

Aim

We propose identifying the genetic predisposition to atherosclerosis progression and events occurrence or regression and better prognosis, through a cohort study from GENEMACOR population.

Methods

We investigated a cohort of 1,712 patients who underwent coronary angiography with more than 70% stenosis of at least one main coronary vessel. 33 SNPs associated with the risk of CAD in previous GWAS were genotyped by TaqMan assays methodology. We evaluated the best genetic model associated with CAD prognosis (events) with a 95% CI in bivariate analysis. The hazard function was performed by a Cox survival regression model adjusted for age, sex, type 2 diabetes, hypertension, and hypercholesterolemia, to evaluate their relationship with the event's incidence. Finally, we constructed Kaplan–Meier cumulative-event curves for the significant genetic variants.

Results

Our evaluation revealed a SNP paradoxically associated with protection from atherosclerosis progression and events occurrence: rs1884613 C>G in the HNF4A gene on chromosome 20 dominant model [OR=0.653; 95% CI (0.522–0.817); p=0.0002]. Cox survival regression model showed a CAD protective effect of HNF4A with a Hazard ratio (HR) of 0.771; p=0.007. The Kaplan-Meier cumulative event analysis disclosed that the CG+GG vs CC genotype of rs1884613 HNF4α was associated with a better prognosis (Breslow test, p=0.004) at the end of the follow-up.

Conclusion

We identified, in this study, one SNPs paradoxically associated with a better CAD prognosis rs1884613 in HNF4A. The HNF4A gene variants could induce loss of HNF4α function, modifying and modulating hepatic lipase and lipid metabolism conferring a beneficial effect on atherosclerosis progression and events occurrence.

Funding Acknowledgement

Type of funding sources: None.
Expression and roles of N-type Ca channel in cardiaomyocytes
Authors: Kobara M , Toba H , Nakata T
Published: October 2021

Background

Voltage dependent Ca channels are divided to L-, T-, N-, P/Q-, and R-types, and N-type Ca channel (NCC) is mainly expressed in nerve terminal and regulates neurotransmitter release. Recently, NCC has been reported to express in adrenal gland and renal tubular cells. We examined whether NCC is expressed in cardiac myocytes and if so, the roles of this channel.

Methods

Expression of NCC mRNA and protein in cardiomyocytes were assessed by quantitative real time PCR and Western blot analysis using neonatal rat cultured cardiomyocytes, infant, and adult rat hearts. Expression site of NCC in cardiomyocytes was examined by confocal imaging of immunofluorescent staining. The roles of NCC in physiological Ca transient in neonatal myocytes were examined using fluorescence imaging of Fluo4, an intracellular Ca indicator. To examine the effects of pathological condition, such as heart failure and ischemia-reperfusion, on NCC expression, cultured cardiomyocytes were treated with norepinephrine (10 μmol/L, 24 hours) or subjected to 5 hours of hypoxia followed by 30 minutes of reoxygenation. In addition, adult rats were subjected to myocardial infarction by ligating the left anterior coronary artery. Lethal myocyte injury was examined by LDH activity in culture medium and myocyte apoptosis was examined by nuclear staining with DAPI and caspase 3 activity. To clarify the roles of NCC in neonatal myocytes in these pathological conditions, we examine the effect of ω-conotoxin, a selective NCC blocker.

Results

NCC mRNA and protein were expressed in neonatal cardiomyocytes. Immunocytochemical staining showed NCC was expressed in myocyte plasma membrane. During physiological spontaneous beating, ω-conotoxin did not affect beating rate and intra cellular Ca transient, suggesting that the roles of NCC on physiological beating are little. After birth level of NCC mRNA expression in cardiac tissue gradually decreased within 2 weeks and low level of mRNA expressed continuously in adult cardiac tissue. However, in pathological condition, mRNA and protein levels of NCC in non-infarcted region were increased 4 weeks after myocardial infarction. In addition, hypoxia-reoxygenation and norepinephrine administration increased LDH release and myocyte apoptosis in association with increase in NCC expression in neonatal cultured myocytes. ω-conotoxin significantly suppressed hypoxia/reoxygenation- and norepinephrine-induced LDH release and caspase 3 activation.

Conclusion

NCC is expressed in neonatal cardiac myocytes and the expression level was decreased after birth. Pathological condition, such as ischemic heart disease and heart failure, upregulated NCC expression in cardiomyocytes and NCC exacerbated lethal myocyte injury, while roles of NCC in physiological beating are little.

Funding Acknowledgement

Type of funding sources: None.