bluuebunny/crossref_metadata_2025 huggingface dataset:
Acute safety and performance outcomes from the inspIRE trial using a novel pulsed field ablation system for the treatment of paroxysmal atrial fibrillation
Authors: De Potter T , Reddy V , Neuzil P , Rackauskas G , Anic A , Grimaldi M , Di Biase L , Natale A
Published: October 2021

Background/Introduction

The inspIRE clinical trial was designed to assess the safety and efficacy of a fully integrated biphasic pulsed field ablation (PFA) system comprised of a multi-channel generator, variable decapolar irrigated loop circular catheter, and mapping system (Figure A) for the treatment of paroxysmal atrial fibrillation (PAF).

Purpose

Using this novel PFA system in a multicentre clinical trial, we present the initial feasibility of electrical pulmonary vein isolation (PVI), procedural performance, and acute safety results.

Methods

inspIRE is a prospective, non-randomized, multi-centre study, planned to enrol up to 550 patients. PVI is performed with the novel, variable loop circular catheter, compatible mapping system and generator. Acute procedural effectiveness (entrance block in all clinically targeted PVs post adenosine/isoproterenol challenge) and the incidence of primary adverse events (PAEs) were assessed. PAEs are defined as the occurrence of cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischemic attack, permanent phrenic nerve paralysis, pulmonary edema, pericarditis, and any major vascular access complications within 7 days of the ablation procedure. Additionally, any incidence of procedure or device related death, atrio-esophageal fistula, or PV stenosis (related to the ablation procedure or study catheter) within the 12M follow-up period is classified as a PAE.

Results

A total of 35 PAF subjects (age 59.7±10.7 years, 54.3% male) were treated across 5 European sites by 6 operators. Acute procedural success was achieved in 100% of study subjects (Figure B) with zero incidence of PAEs. Mean total procedure time was 82.9±19.9 minutes with 27.0±11.9 minutes of PFA from first to last application. Average fluoroscopy use was 10.6±6.8 minutes and LA dwell time was 45.6±15.3 minutes.

Conclusion

Initial results of the inspIRE trial demonstrate the acute safety and effectiveness of the new integrated IRE circular catheter, mapping system and generator for PVI in PAF patients.

Funding Acknowledgement

Type of funding sources: Other. Main funding source(s): inspIRE is a company-sponsored study funded by Biosense Webster, Inc. Figure 1. (A) PFA System; (B) PVI Voltage Map
Complications of epi- and endocardial pacing in children
Authors: Dzhaffarova O , Svintsova L , Plotnikova I
Published: October 2021

Aim

To analyze complications of cardiac pacing in children depending on the implantation method.

Actuality

Recently epicardial lead implantation becomes more and more popular either due to more serious complications of transvenous pacing or due to possibility of choice of hemodynamically optimal pacing zone.

Methods and materials

242 patients with pacemakers are under our supervision. Epicardial pacemakers were implanted to 145 patients, endocardial – to 97 patients. In “old era” in most children the primary epicardial implantations were performed at RV free wall. In 27 children, having primary implantation at our Institute lately, the epicardial lead was placed at LV apex, or endocardial – at RV apex.

Results

The comparative analysis of complications of epi- and endocardial implantation showed the following results: 22% of complications at epicardial stimulation, and at transvenous stimulation – 45%.

The most often complications at epicardial stimulation (53%) were connected with hemodynamic disorders – dyssinchronous cardiomyopathy. Hemodynamic complications, connected with dyssinchrony of endocardial RV pacing, were disclosed in 16%.

The most often complication of endocardial stimulation was TV insufficiency (32%). Venous vessel thrombosis was diagnosed in 9%.

Epicardial and transvenous lead failure was discovered in similar percentage ratio (28%).

Infectious complications of transvenous pacing, especially, bacterial endocarditis, took place in 6,8%. Thus, progressive bacterial endocarditis and TV insufficiency (3d deg.) appeared in one patient in 10 years after the primary implantation. Afterwards, elimination of endocardial system by open surgery, TV plasty followed by epicardial pacing implantation are required. Infection of pacing site was disclosed in both types of implantation (1%). Perforation of atrial endocardial lead was found in two cases (4%).

A case of mechanical complication (cardiac strangulation) was diagnosed in a child (3%) in four years after the primary implantation of epicardial pacing system. Pericarditis was recorded immediately after the epicardil pacemaker implantation in 9% of cases.

Our center performs epicardial lead implantation with the help of midline sternotomy that provides clear approach to right atrium. However, the difficulties of lead fixation at LV apex appear here. It concerns, especially, the patients after CHD correction as the repeated sternotomy in them presents high risk of RV insufficiency. Nevertheless, the given approach is still the best possible with epicardial pacing if there is a “preclude”, sufficient experience of CHD correction.

Conclusion

The possibility of choice of optimal epicardial pacing site exceeds risks of leads and midline sternotomy. Any primary pacemaker implantation in children of any age with ventricular lead should be epicardial.

Funding Acknowledgement

Type of funding sources: None.
Prognostic value of strain rate during isovolumic relaxation in a general population
Authors: Papangelopoulou K , Orlowska M , Cauwenberghs N , Voigt J U , Kuznetsova T , D'hooge J
Published: October 2021

Background

Left ventricular (LV) strain rate (SR) during isovolumic relaxation (SRIVR) has been shown to correlate with invasive measurements of diastolic function, namely the time constant of LV relaxation (τ), and has thus been proven useful in the assessment of diastolic function. Tissue Doppler imaging (TDI) has an adequate frame rate to resolve the SR during a short-lived mechanical event such as IVR.

Purpose

The purpose of this study was to assess the additive prognostic value of SRIVR on top of conventional cardiovascular risk factors in a general population.

Methods

We included 670 subjects (age: 51.2±14.2, 48.8% males) that were already recruited in the Flemish Study on Environment, Genes and Health Outcomes (FLEMENGHO), from May 2005 to February 2009. Subjects were followed up on average 5 years after their recruitment, either by a follow-up visit or by telephone. Exclusion criteria at baseline were atrial fibrillation, presence of an artificial pacemaker, more than mild valvular disease and segmental wall motion abnormalities. All patients underwent echocardiographic examination with a state of the art ultrasound machine. Using an in-house developed software package (SPEQLE), we extracted the velocity, strain and SR curves from the color TDI images (FR >180Hz) and imposed timing information on the IVR based on valve opening/closing as determined from PW Doppler data. The sample volume was positioned at the mid portion of the inferolateral wall, in an apical 3 chamber view, manually tracked over the cardiac cycle and all curves were averaged over 3 subsequent cardiac cycles. Then, SRIVR was estimated as the peak SR value during IVR (Fig. 1). Outcome data consisted of major adverse cardiac events (MACE) during the follow-up period. The hazard ratio (HR) associated with SRIVR values was estimated using Cox regression analysis; we included age, sex, body mass index, systolic blood pressure, smoking and serum cholesterol as co-variables in the model.

Results

An accurate assessment of the SRIVR in the inferolateral wall was not possible in 34 participants, so further analysis was confined to 636 subjects. In total, 65 adverse cardiac events were recorded over the period of 8.7 years of follow-up. Figure 2 demonstrates the cumulative incidence estimates (1-Kaplan-Meier survival estimates) of composite cardiac events in quartiles of SRIVR measured in the inferolateral wall (log-rank test p=0.005). Overall, after adjustment for the important cardiovascular risk factors, SRIVR of the inferolateral wall analyzed as a continuous variable was a significant predictor of fatal and nonfatal cardiac events (HR 1.94 (95% CI 1.09–3.47); p=0.025).

Conclusion

SRIVR measured in the inferolateral wall is an important biomarker not only in assessing diastolic function but also as a significant predictor of future adverse outcomes.

Funding Acknowledgement

Type of funding sources: None.
Clinical factors predicting asymptomatic atrial fibrillation in Middle Eastern patients
Authors: Al-Makhamreh H , Tutanji L , Abdin B , Salaymeh O , Al Karmi F , Abu Eid E , Obiedat A , Zaqqa M , Hammoudeh A , Hamam I , Kadri N ,   Jordan AF study
Published: October 2021

Introduction

Anticoagulation has been shown to be highly effective in stroke prevention in patients who have atrial fibrillation (AF). Many patients with AF do not have symptoms and may not seek medical attention. In this study we evaluated the clinical profiles of asymptomatic AF (AAF) patients and compared them to symptomatic ones to find what factors are associated with absence of symptoms.

Methods

We analyzed data of 2000 patients enrolled in the prospective multicenter Jordan AF study from May 2019 to October 2020. Symptoms included palpitations (43%), shortness of breath (34%), fatigue (21%), dizziness (11%), chest pain (2%) or syncope (2%) versus no symptoms (30%, n=591).

Findings

The average age of the whole group was 67.7±10.2 years and 47% were males. Clinical factors investigated in relation to absence of symptoms are presented in the attached table

Conclusion

AAF is associated with the following clinical features: male gender, age above 59 years, diabetes mellitus (DM), cerebrovascular accident (CVA), and chronic renal failure (CRF), CHA2DS2VASC score of 3 and above and HASBLED score of 3 and above, while first episode and paroxysmal AF (PAF) were more likely to be symptomatic. Individuals with these features should be closely evaluated for AAF by means such as pulse monitoring, smart devices and electrocardiogram.

Funding Acknowledgement

Type of funding sources: None.
Social-occupational impact and level of satisfaction in patients included in a remote monitoring pacemaker programme
Authors: Perez Diaz P , Bastante Diaz M C , Campos Perez De Madrid E , Fernandez Trujillo A , Cano Rosado L , Jimenez Diaz J , Higuera Sobrino F , Bermejo Calvillo N , Casas De Miguel A M ,   University General Hospital of Ciudad Real, Ciudad Real, Spain.
Published: October 2021

Background

When patients fitted with pacemakers have to attend arrhythmia appointments, this often reduces their independence and involves their caregivers having to take time off work, along with an increase in spending on healthcare transport.

Purpose

We describe the impact of remote monitoring of pacemaker implemented by our Arrhythmia Unit in our patient's live and the reduction in social, occupational and financial impact on these patients.

Methods

Prospective observational study including 160 patients on the remote monitoring pacemaker programme between January 2016 and January 2017. We handed a satisfaction survey to these patients after the face-to-face monitoring appointment, which analysed variables such as waiting time, attention and treatment received, need for accompaniment of a relative, method of travel and kilometres travelled, level of satisfaction with the remote monitoring system, proposals for improvement, etc.

Results

The patients spent a median of 60±30 minutes on the remote monitoring, with a distance travelled of 1.4±4.9 km, rating their level of satisfaction at the remote monitoring as excellent (35%), good (61%) and average (3%) (Figure 1). In the face-to-face appointment, most of them were accompanied (86%) and arrived by private car (66%), with 54% of family members needing to take time off work. 19.4% of patients arrived by ambulance and 8.8% by bus. The median time spent was 150±120 minutes, and the distance travelled was 63±105 km.

Conclusions

The remote monitoring pacemaker programme in our health district has a very positive healthcare and social-occupational impact, which is manifested both from an objective point of view (greater independence, less time spent per appointment, less distance travelled, fewer healthcare transport needs and less workplace absenteeism by family members, etc.) and a subjective point of view (lower impact of appointments on patients' lives and greater perception of satisfaction from the patients and their companions).

Funding Acknowledgement

Type of funding sources: None.
Association between atrial fibrillation and coronary slow flow
Authors: Zhuang Z.X.D , Zhang S.Z , Liao X.X
Published: October 2021

Background

The relationship between arrhythmia and coronary slow flow (CSF) is unclear. We aimed to explore the association between atrial fibrillation (AF) and CSF.

Method

In this cross-sectional study, we included 2,060 participants patients from PCI-registry (NCT 02498470) who underwent coronary angiography with clinical chest pain and without significant coronary stenosis. According to coronary blood flow rate measured by the thrombolysis in myocardial infarction frame count (TFC) method, CSF was defined as TFC>27. AF was identified by ECG performed during hospitalization. We used logistic regression to assess the association between AF and CSF.

Results

Among 2,060 participants, 132 participants were diagnosed with AF. CSF rates were higher in AF group than in the control group (22.0% vs 13.9%, P=0.011). Logistic regression showed that AF was independently associated with CSF after adjustment for traditional risk factors (OR=2.06; 95%, 1.28–3.34; P=0.003).

Conclusion

Our study demonstrated that AF was association with increased risk of CSF. Further studies are needed to confirm this finding and explore the potential mechanism.

Funding Acknowledgement

Type of funding sources: None.
Comparison of the HAS-BLED, ORBIT and ATRIA bleeding risk scores in 399,344 patients with atrial fibrillation and cancer
Authors: Pastori D , Marang A , Bisson A , Herbert J , Lip G.Y.H , Fauchier L
Published: October 2021

Background

The presence of cancer worsens the prognosis of patients with atrial fibrillation (AF). However, the association between cancer type and specific bleeding events has been scarcely investigated. Furthermore, the performance of bleeding risk scores, such HAS-BLED, ORBIT and ATRIA, in this high-risk subgroup of AF patients is unclear.

Purpose

To investigate the incidence rate (IR) of major, gastrointestinal (GI) bleeding and intracranial haemorrhage (ICH) according to cancer types. We also investigated the performance of HAS-BLED, ATRIA and ORBIT scores. HASBLED ≥3, ATRIA ≥5 and ORBIT ≥4 were defined as high-risk.

Methods

Observational retrospective cohort study including 399,344 patients with AF and cancer.

Results

Mean age was 77.9±10.2 years and 63.2% were men. During a mean follow-up of 2.0 years, the IR of major bleeding was as high as 8.41%/year, GI bleeding was 3.61%/year and ICH 1.33%/year. Major bleedings were more frequent in liver (12.68%/year), leukaemia (12.39%/year), pancreas (11.71%/year), bladder (11.67%/year) and myeloma (11.64%/year). GI bleeding were highest in liver (7.54%/year), pancreas (7.42%/year) and gastric (5.51%/year). The highest IR of ICH was found in leukaemia (1.89%/year), myeloma (1.52%/year), lymphoma and liver (1.45%/year) and pancreas cancer (1.41%/year).

Figure 1 shows the hazard ratios and AUC values for the three scores against each endpoint. All the three scores were significantly associated with major, GI and ICH. The HAS-BLED score performed better than others for ICH prediction, while the ORBIT score showed the best predictivity for major and GI bleedings (p<0.0001 for all AUC comparisons)

Conclusions

Cancer increases the risk of bleeding in patients with cancer, with specific differences according to each cancer type. HAS-BLED score identified patients at highest risk for ICH and the ORBIT score for major and GI bleeding.

Funding Acknowledgement

Type of funding sources: None. Figure 1
Ischemic stroke in low risk patients with atrial fibrillation: a nationwide, registry-based cohort study
Authors: Mandalenakis Z , Spanos E , Sandstrom T.V.S , Rosengren A.R , Hansson P.O.H
Published: October 2021

Background

Despite the good evidence on the prevention of ischemic stroke in high risk patients with atrial fibrillation (AF), the knowledge in AF patients without any cardiovascular risk factors is still limited and the treatment has been highly questioned.

Methods

We linked data from Swedish health registers to identify all patients with AF but without any previous cardiovascular comorbidity. The risk of ischemic stroke was investigated by using Cox regression models and patients with AF compared with two controls without AF, matched for age and sex.

Results

Altogether, 229,613 patients with AF and 457,332 matched controls without AF were included in the study; 44.4% of the population were women. Both the 1-year and the 5-year risk to develop ischemic stroke was higher in patients with AF compared to their matched controls without AF, hazard ratio (HR) of 3.7 (95%, confidence interval (CI) 3.5–3.8) and 2.5 (95%, CI 2.5–2.6) respectively. According to the age groups, patients with age of 35 to 49 years had the highest risk to develop ischemic stroke within the first year after AF diagnosis, HR 8.3 (95%, CI 4.0–17.1). Women with AF had 4.4 times higher risk to develop ischemic stroke (HR 4.4, CI 4.2–4.7) compared to matched women without AF.

Conclusions

In this large, register-based, nationwide cohort study, we found that the 1-risk and 5-year risk to develop ischemic stroke was significantly higher in patients with AF but without any cardiovascular risk factor for stroke, compared to matched controls without AF. Women and middle-aged patients with AF carried the highest risk to develop ischemic stroke indicating the need of further research on risk stratification despite traditional factors.

Funding Acknowledgement

Type of funding sources: Public hospital(s). Main funding source(s): The Swedish state and The Swedish Research Council
Impacts of off-label dosing noacs on clinical outcomes in very elderly patients with atrial fibrillation
Authors: Chao T , Chan Y.H , Lip G.Y.H , Chen S.A
Published: October 2021

Background

Studies about the comparisons of on-label and off-label dosing non-vitamin K antagonist oral anticoagulants (NOACs) regarding the risks of clinical outcomes among atrial fibrillation (AF) patients have been published. However, data among the very elderly AF patients were limited. In the present study, we aimed to investigate the impacts of inappropriate dosing of NOACs on clinical outcomes in AF patients aged ≥85 years of age.

Methods

We used medical data from a multi-center healthcare system in Taiwan enrolling 1,836 and 268 AF patients aged ≥85 years treated with NOACs and warfarin, respectively. Among 1,836 patients receiving NOACs, underdosing, overdosing and on-label dosing NOACs were prescribed in 248, 149 and 1439 patients, respectively. The risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding were compared between warfarin and NOACs in different dosing groups. Also, the risks of clinical events of underdosing and overdosing NOACs were comapred to on-labeling dosing.

Results

Compared to warfarin, underdosing NOACs were associated with a higher risk of IS/SE (aHR 2.39; p=0.048) without a lower risk of major bleeding; while overdosing NOACs were not associated with a lower risk of IS/SE (aHR 0.74, p=0.604) (Figure 1). Compared to on-label dosing NOACs, underdosing NOACs were associated with a higher risk of IS/SE, while the risk was not lower for overdoing NOACs (Figure 2).

Conclusions

Even for very elderly AF patients aged ≥85 years, NOACs should still be prescribed at the dosing following the criteria defined in clinical trials and guideline recommendations.

Funding Acknowledgement

Type of funding sources: None. Figure 1Figure 2
Clinical significances of prothrombin time-international normalized ratio and activated partial thromboplastin time in patients with atrial fibrillation treated with direct oral anticoagulants
Authors: Chao T , Chan Y.H , Chen S.A
Published: October 2021

Background

Although the measurements of PT-INR or aPTT were not performed for patients with atrial fibrillation (AF) taking direct oral anticoagulants (DOACs) in randomized trials, these tests were commonly used and familiar to clinical physicians. We aimed to test whether there is an association between PT-INR or aPTT ratio and risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding among AF patients taking rivaroxaban or dabigatran, respectively.

Methods

This multi-center cohort study included 3,192 AF patients taking rivaroxaban and 958 patients taking dabigatran for stroke prevention whose data about PT-INR and aPTT were available.

Results

For patients treated with rivaroxaban, a higher INR level was not associated with a higher risk of major bleeding compared to an INR level <1.1. The risk of IS/SE was lower for patients having an INR ≥1.5 compared to those with an INR <1.1 (aHR: 0.57; [95% CI: 0.37–0.87]; P=0.0088) (Figure). On-label dosing of rivaroxaban and use of digoxin were independent factors associated with an INR ≥1.5 after taking rivaroxaban. For patients taking dabigatran, a higher aPTT ratio was not associated with a higher risk of major bleeding. The risk of IS/SE was lower for patients having an aPTT ratio of 1.1–1.2 and 1.3–1.4 than those with an aPTT ratio <1.1.

Conclusions

In Asian AF patients, PT-INR or aPTT ratios were not associated with the occurrences of bleeding events for rivaroxaban or dabigatran. Patients taking rivaroxaban with an INR ≥1.5 were associated with a lower risk of IS/SE. Appropriate dosages of DOACs and the compliances of patients should be confirmed for patients taking rivaroxaban with an INR <1.5.

Funding Acknowledgement

Type of funding sources: None.
A novel research platform for sudden cardiac death based on continuous, real-life, unlimited follow-up of a cohort of high-risk patients
Authors: Boveda S.B ,   DAIPP consortium
Published: October 2021

Background/Introduction

Currently, Sudden Cardiac Death (SCD) prevention is mainly based on implantable cardioverter-defibrillator (ICD) implantation in high risk patients. Real-time, prospective follow-up of such high-risk patients can afford a unique opportunity to improve SCD prevention. We previously conducted an exploratory retrospective project (DAIPP pilot program) focusing on >5 000 ICD recipients, which provided us with valuable information and knowledge to set up a wider, prospective project (1–11).

Purpose

We present here the organizational outline for an innovative research platform for SCD, based on a real-life cohort with continuous, unlimited follow-up. The overall aim is to garner high-value information which can help optimize individualized risk stratification, cardiac defibrillation, and preventive strategies to eventually decrease SCD burden.

Methods and results

The DAIPP Consortium is an investigator-initiated, prospective, multicentre, independent, long-term, academic cohort study, focusing on patients at high risk of SCD and implanted with an ICD. More than 5 000 ICD recipients will be enrolled prospectively and consecutively through 17 French tertiary public and private hospitals during the first three years. All patients will be monitored continuously through a unique remote monitoring platform, and they will be linked to the national “Health Data Hub”, gathering information about medications, hospitalizations and outcomes. Quality and exhaustivity of the collected data will be regularly monitored through systematic monthly automatic indices in each center. Events will be centrally adjudicated. For the 2021–2023 period, 6 work-packages have already been created within the research platform, some being clinical and others translational research, including ischemic cardiomyopathy, new technologies, congenital cardiomyopathies, channelopathies, complications and artificial intelligence, to develop new approaches. Concomitantly, the consortium will be open to external collaborations, and an academic research program has been initiated with various European universities to enable Master, PhD and Post-doctoral students to conduct their research on SCD.

Conclusion

DAIPP is an investigator-initiated real-life continuous follow-up cohort of patients at high risk of SCD. This project will provide an open research platform to enhance the understanding of, and improve preventive strategies for SCD.

Funding Acknowledgement

Type of funding sources: Other. Main funding source(s): Inserm, Société Française de Cardiologie, Clinique Pasteur
The ADDition of DAPAgliflozin to angiotensin receptor blocker-neprilysin inhibitors non-responders in patient with refractory HFrEF
Authors: Jariwala P , Jadhav K.P
Published: October 2021

Objectives

We evaluated the efficacy and safety of dapagliflozin, a SGLT2i along with ARNI in refractory HFrEF irrespective of their diabetic status.

Methods

We performed a prospective, open-label study of symptomatic patients of HFrEF despite of optimal medical management with ARNI between January–June 2020. Despite the maximum tolerated dose of ARNI and other medications in patients the symptoms of heart failure persisted. The initial dose of 5 mg was started and after 4 weeks irrespective of their glycemic control, then the dose was escalated to 10 mg. They were followed for the 6-months after the combination of ARNI and SGLT2i.

Results

The 104 patients who had HFrEF despite of optical medical management were added dapagliflozin on top of ARNI. The primary endpoint of mean change in Left Ventricular ejection fraction (LVEF) +9.00±0.62 with a significant p value of <0.001. The Mean difference in NYHA class was −2.9±0.057. A study of 104 patients at 6-months follow-up found that 92.6% of patients were in NYHA class I and 7.4% were in NYHA class II. They also reached the HbA1C goal of <7% in the diabetic subgroup. None of them had either symptomatic hypotension, dyselectrolytemia, and elevation of serum creatinine. The drug was well received by most patients (Picture 1).

Conclusions

Dapagliflozin are not only oral hypoglycaemic agents but can be used in refractory HFrEF despite the use of ARNI. The combination of the ARNI and SGLT2i is well tolerated but we need large, randomized trials to prove this hypothesis (Picture 2).

Funding Acknowledgement

Type of funding sources: None. Picture 1. Screening and outcomes of patientsPicture 2. Graphical abstract
12-month post-trial follow-up of participants in the Australian arm of the second low-dose colchicine trial
Authors: Nidorf S M , Budgeon C , Eikelboom J W , Murray K , Nidorf L , Thompson P L ,   The LoDoCo2 Steering Committee
Published: October 2021

Background

In the Australian arm of the LoDoCo2 trial, colchicine 0.5mg daily compared with placebo markedly reduced the risk of cardiovascular (CV) events in patients with chronic coronary disease (2.0 vs 3.9 events per 100 person years, HR 0.51; 95% CI 0.39–0.67). The purpose of this analysis was to explore CV and non-CV outcomes in the Australian cohort out to one year after cessation of trial medication.

Methods

Information was collected on all potential CV events and non-CV deaths as well as a range of other co-morbidities. All CV events were blindly adjudicated. The analysis examined the primary outcome (a composite of CV death, myocardial infarction, ischemic stroke, and unscheduled revascularization) and non-CV deaths by initial randomized treatment from the beginning of the trial up until one year after cessation of trial medication. A landmark analysis was then used to examine these outcomes from the date of last contact during the trial until one year after cessation of trial medication.

Results

The clinical status was confirmed in 1819/1824 (99.7%) participants who were alive at the end of the trial, and in 100% of those participants still taking trial medication at the end of the trial. During post-trial follow up, 515 patients (28.2%) were taking non-study colchicine, including 278 (30.5%) originally randomized to colchicine and 237 (25.9%) randomized to placebo. Over the entire follow-up period that included the 12-month period after the trial medication was ceased, the effect of prior exposure to colchicine on the primary CV outcome was still evident (2.2 vs 3.8 events per 100 person years, HR 0.58; 95% CI 0.45–0.74), however no post-trial CV benefit were apparent in the landmark analysis (3.3 vs 3.4 events per 100 person years, HR 0.97; 95% CI 0.56–0.1.69). Over the entire course of follow-up the incidence of new cancer (7.9% vs 7.2% RR 0.91; 95% CI 0.66–1.25) and non-CV death (0.9 vs 0.6 events per 100 person years, HR 1.44; 95% CI 0.92–2.27) was no different in the treatment groups.

Conclusion

Although the CV benefits of colchicine treatment that emerged during the trial were still evident in the year after stopping study treatment, no additional CV benefit accrued after it was ceased. These data suggest that colchicine should be continued long-term to maximize its CV benefits.

Funding Acknowledgement

Type of funding sources: None.
The association between diabetes and mortality in young adults presenting with myocardial infarction
Authors: Gyurjian K , Chiu S , Hammershaimb B , Nadadur M , Phan P , Shen Y J , Lin B , Lee M S
Published: October 2021

Background

The incidence of diabetes mellitus and coronary artery disease continue to rise and collectively comprise two of the most prevalent and costly diseases worldwide. The goal of this study is to report the prognosis of young patients with diabetes presented with acute myocardial infarction (AMI).

Methods

This is a retrospective observational cohort study that included consecutive patients aged 18–45 years who underwent cardiac catheterization for AMI between 2006 and 2016 in an integrated healthcare system in Southern California. The prognosis of patients with diabetes were compared to those without diabetes.

Results

A total of 1,560 patients (average age 40.2±5.3 years, 25.6% female) presenting with AMI were included. Of these 272 (17.4%) had diabetes. Diabetics were older (41.1±4.4 vs 40.0±5.4 years), more likely to be female (32.4% vs 24.1%, p=0.006), Hispanic (51.5% vs 40.5%, p<0.001), have a higher body mass index (BMI) (33.6±7.1 vs 31.2±6.8kg/m2, p<0.001), have hypertension (HTN) (67.6% vs 23.8%, p<0.001), hyperlipidemia (HLD) (78.3% vs 24.1%, p<0.001), peripheral vascular disease (9.9% vs 1.9%, p<0.001), chronic kidney disease (CKD) (23.2% vs 2.7%, p<0.001), hypothyroidism (7% vs 4%, p=0.034), and prior strokes (4.4% vs 2.2%, p=0.034).

On multivariate analysis accounting for other cardiovascular risk factors, the association remained significant (OR 1.82, 95% CI 1.04–3.19, p=0.036). At a median follow-up of 5.8 years (interquartile range 3.7–8.7 years), diabetes was independently associated with increased all-cause mortality (Hazard ratio [HR] 3.10, 95% CI 1.68–5.69, p<0.001) when adjusting for age, sex, race, BMI, HTN, HLD, CKD, hypothyroidism, prior stroke, and ACS etiology. In a propensity score matched cohort, diabetes remained significantly associated with all-cause mortality (HR 5.29, 95% CI 2.34–12.02, p<0.001).

Conclusion

Diabetes is an independent predictor of increased mortality in young adults <45 years old presenting with AMI.

Funding Acknowledgement

Type of funding sources: Private hospital(s). Main funding source(s): KAISER PERMANENTE LOS ANGELES MEDICAL CENTER
Impact of epicardial adipose tissue accumulation on left ventricular mass and hypertrophy in non-obstructive coronary artery disease
Authors: Khan I , Eskerud I , Larsen T H , Berge C A , Pedersen E R , Lonnebakken M T
Published: October 2021

Introduction

Increased left ventricular mass index (LVMi) and left ventricular hypertrophy (LVH) by echocardiography are common in obesity and important cardiovascular risk predictors associated with myocardial ischemia in non-obstructive coronary artery disease (CAD). Accumulation of epicardial adipose tissue (EAT) suggest a possible direct impact on LVMi and LVH.

Purpose

To explore the association between EAT volume, LVMi and LVH in patients with chest pain and non-obstructive CAD.

Methods

We included 129 patients with chest pain and non-obstructive CAD (<50% stenosis) by coronary computed tomography (CT) angiography. EAT volume was quantified using a semiautomatic analysis software on non-contrast cardiac CT images. Patients were grouped according to EAT volume, where high EAT volume was adjudicated when EAT volume was in the highest tertile (≥125 ml). Left ventricular mass was assessed by echocardiography, calculated by the Devereux formula and indexed for height in the allometric power of 2.7 (LVMi). LVH was defined as LVMi >46.7 g/m2.7 in women and >49.2 g/m2.7 in men. Coronary artery plaque burden was assessed as calcium score and segment involvement score on coronary CT angiography.

Results

High EAT volume was more common in men with higher BMI, waist circumference, serum triglycerides and higher prevalence of hypertension and obesity (all p<0.05). Age, coronary calcium score and coronary artery segment involvement score did not differ between groups. Patients with high EAT volume had higher LVMi compared to those with low EAT volume (42.5 g/m2.7 vs. 36.1 g/m2.7, p=0.003), while there was no difference in EAT volume among patients with or without LVH. In univariable logistic regression analysis, high EAT volume was associated with higher LVMi (OR 1.05 [95% CI 1.01–1.10] per g/m2.7, p=0.015). After adjusting for hypertension and obesity in a multivariable model, higher LVMi remained significantly associated with high EAT volume (Model 1, Table 1), but the association was attenuated after adjusting for sex (Model 2, Table 1).

Conclusion

High EAT volume was associated with increased LVMi in patients with non-obstructive CAD, independent of hypertension and obesity, while there was no association with LVH. This suggest that direct infiltration of adipose tissue in the myocardium may contribute to the development of increased LVMi.

Funding Acknowledgement

Type of funding sources: Public Institution(s). Main funding source(s): Western Norwegian Regional Health Authorities Table 1
Prognostic impact of CTO lesion in NSE-ACS patients: three-year outcome
Authors: Boukerche F , Laredj N
Published: October 2021

Introduction

CTO represents the most advanced form of CAD and affects adverse clinical outcomes in patients with AMI due to several pathophysiological mechanisms

Purpose

The aim of this study was to determine the prognostic impact of chronic total occlusion (CTO) on two-year outcome in a prospective cohort of NSTE-ACS patients.

CTO is present in many patients with NSTE-ACS and is difficult to treat with percutaneous coronary intervention.

Methods

Patients admitted for NSTE-ACS and indication for coronary angiography were prospectively evaluated. Patients were divided into 2 groups according to whether CTO lesions were vs. were not present. Major outcomes were assessed at 3 years.

Results

A total of 296 patients were evaluated: mean age was 62±12 years and 58% were male. The three-year mortality was 12.2% (36 patients) and the three-year MACCE was 26.4% (78 patients).

The CTO group included 38 patients (12.2%). The three-year mortality and MACCE in the patients of CTO group was significantly higher (26.3% vs. 10.1%; p=0.013) and (50.0% vs. 22.9%; p=0.001) respectively.

Conclusion

In this prospective observational study of patients with NSTE-ACS, CTO was associated with a worst three-year outcome.

Funding Acknowledgement

Type of funding sources: None. MACCE: CTO Vs No CTO lesion
The incidence, time distribution and prognostic value of monomorphic ventricular tachycardia in ST-elevation myocardial infarction: the prespecified analysis of VALIDATE SWEADHEART trial
Authors: Demidova M M , Rylance R , Koul S , Dworeck C , James S , Aasa M , Erlinge D , Platonov P G
Published: October 2021

Background

The assessment of prognostic impact of ventricular arrhythmias in ST-elevation myocardial infarction (STEMI) is currently based mainly on their timing with regard to the symptom onset and does not distinguish between monomorphic ventricular tachycardia (VT) and polymorphic VT/ventricular fibrillation (VF). However, recent data indicate long-term hazard of monomorphic VT occurring early in the course of STEMI.

Purpose

To evaluate the incidence, time distribution and prognostic value of early monomorphic VT compared to polymorphic VT/VF in STEMI patients treated by primary percutaneous coronary interventions (PCI).

Methods

A prespecified analysis of the multicentre prospective registry-based randomised VALIDATE-SWEDEHEART trial included STEMI patients enrolled at 16 sites in Sweden between June 2014 and September 2016. Source data verification regarding the type and timing of arrhythmia from all patients with VT/VF during STEMI was performed. Survival status was obtained from the Swedish national population registry. Endpoint was total mortality at 180 days.

Results

In total, 2886 patients were identified. Among them, 97 (3.4%) had VF or polymorphic VT, 16 (0.5%) monomorphic VT, 6 (0.2%) had other undefined shockable rhythm. Total mortality (10.9% vs 2.8%, p≤0.001) was higher among patients with VT/VF. VT/VF was associated with total mortality (HR 3.18 95% CI 1.74–5.8; p≤0.001) after adjustment on age, gender and myocardial infarction localisation. In patients discharged from hospital, VT/VF did not influence the long-term prognosis.

Patients with monomorphic VT had similar clinical characteristics as compared to those with polymorphic VT/VF. The time distribution of VT/VF differed with regard to the type of arrhythmia: 63% of monomorphic VT/VF episodes occurred after PCI (n=10) compared to 24% (n=23) of all documented polymorphic VT/VF, p=0.003. Total mortality (12.5% vs 10.3%, p=0.678) did not differ between patients with monomorphic VT and polymorphic VT/VF. In Cox model, total mortality was not associated with the type of arrhythmia (Figure).

Conclusion

Early VT/VF is a marker of poor short-term outcome in patients with STEMI, which does not affect long-term prognosis in those who are successfully resuscitated and discharged from hospital.

The incidence of monomorphic VT in STEMI treated by primary PCI is low, and it occurs mainly after PCI. Though no significant difference in mortality was found between patients with monomorphic VT and polymorphic VT/VF, the observed low incidence hampers drawing conclusions with regard to the prognostic hazard impact of monomorphic VT.

Funding Acknowledgement

Type of funding sources: Foundation. Main funding source(s): The Swedish Heart Lung Foundation
Routine snuffbox approach do not reduce radial artery occlusion in comparison with conventional transradial access
Authors: Kozinski L , Dabrowska-Kugacka A , Orzalkiewicz Z
Published: October 2021

Background/Introduction

Postprocedural radial artery occlusion (RAO) is still the Achilles' heel of conventional transradial approach (cTRA) as it limits its reuse for future coronary procedures. A distal transradial access (dTRA) via the anatomical snuffbox has been proposed as an alternative. It is hypothesised that dTRA may reduce the incidence of RAO.

Purpose

To assess whether routine dTRA reduce the risk of RAO in consecutive patients undergoing coronary angiography or intervention, in comparison with cTRA.

Methods

Out of 465 subjects, 400 patients were included in a prospective, single-center, randomized (1:1) study. Hemodynamic instability, ST-elevation myocardial infarction, forearm artery occlusion or prior radial access failure were the exclusion criteria. Ultrasound-guided follow-up was obtained after 1 day and 60 days to evaluate the incidence of acute and late RAO.

Results

Baseline characteristics of patients were matched. Results are presented in table 1.

Conclusion(s)

The incidence of postprocedural acute and late RAO after routine dTRA and cTRA is low and occur with similar frequency when evaluated by ultrasound.

Funding Acknowledgement

Type of funding sources: None. Table 1
Age and gender disparities in the prevalence of lipitension
Authors: Grinshtein Y U , Ruf R , Shabalin V
Published: October 2021

Introduction

Lipitension is the presence of hypertension and dyslipidaemia in one person. It multiplies cardiovascular risk up to three-fold and therefore requires timely diagnosing and treatment.

Purpose

In the present study, we calculated the prevalence of lipitension and its disparities depending on gender and age.

Methods

We used the randomized sample of the ESSE-RF study that included 1603 urban and rural Krasnoyarsk Krai inhabitants aged 25–64. Each study participant signed informed consent and underwent the questionnaire, office blood pressure measurement, anthropometry, and biochemical blood analysis. Hypertension criteria were the measured systolic blood pressure at 140 mm Hg or higher, the measured diastolic blood pressure at 90 mm Hg or higher, or antihypertensive medications intake. Dyslipidaemia criteria were the total cholesterol level higher than 5.0 mmol/l, the low-density lipoprotein level higher than 3.0 mmol/l, the high-density lipoprotein level lower than 1.0 mmol/l in males and 1.2 mmol/l in females, or triglycerides level higher than 1.7 mmol/l.

Results

In 40.0% of people, we found a combination of at least one hypertension criterion and at least one dyslipidaemia criterion. The prevalence of lipitension significantly (chi-square for trend; p<0.001) increased from 10.7% in the 25–34 age group to 66.6% in the 55–64 age group. At a younger age, males had dyslipidaemia more frequently than females, while at 55–64, the prevalence of lipitension was higher in females. The details of age and gender disparities are shown in Table 1.

Conclusion

At least 40% of the general population and two-thirds of people older than 55 have lipitension and need a combined antihypertensive and lipid-lowering therapy.

Funding Acknowledgement

Type of funding sources: None. Table 1
DPP4 inhibitors as a risk factor for QTC interval prolongation among type 2 diabetic patients
Authors: Enero R J , Amora J
Published: October 2021

Introduction

Prolonged QT interval is associated with cardiac arrhythmias and sudden death. This study determined the prevalence of QT intervals corrected for heart rate (QTc) among adults admitted for executive check up in a tertiary hospital with Type 2 diabetes and its associations with metabolic control.

Methods

This cross-sectional study included 111 adult patients with Type 2 diabetes and 152 control patients admitted for executive check up in a tertiary hospital. A standard 12-lead electrocardiogram was recorded. Corrected QT interval (QTc) of >440 ms was considered abnormally prolonged and QTc >500 ms was considered a high-risk QTc. Demographic, clinical and laboratory data were collected. Independent risk factors for prolonged QTc were assessed using logistic regression analysis.

Results

QTc duration was statistically significant between subjects with Type 2 diabetes and control subjects (mean duration 434 vs 419 ms; P=0.003). Prevalence of prolonged QTc among type 2 diabetics is 41.4% and 28% in the control group. In the diabetic group 2.7% has a QTc of >500. Independent risk factors for prolonged QTc using univariate logistic regression analysis is presence of diabetes type 2 (OR = 2.00, p=0.008), HBA1c (OR = 1.23, p=0.050) and intake of DPP4 (OR=6.46, (p≤0.001). Independent risk factors for prolonged QTc using multivariate logistic regression analysis is intake of DPP4 inhibitors (OR=6.26, p=0.023).

Conclusion

There is no significant correlation between HBA1C and QTc interval. The prevalence of prolonged QTc is relatively high among diabetics but the prevalence of high risk QTc interval is relatively low. Intake of DPP4 inhibitors is an independent risk factor in QT prolongation.

Funding Acknowledgement

Type of funding sources: None.
Feasibility of remote support for electrophysiological ablation procedures during CoVid-19 pandemics
Authors: Muessigbrodt A , Demoniere F , Finoly S , Mommarche M , Inamo J
Published: October 2021

The COVID-19 pandemics is a global challenge with a huge impact on medicine, politics, economy, education, travel and many other aspects of human life.

The treatment of heart rhythm disorders has also been affected by the disease itself and by restrictions in order to constrain the spread of the virus.

Catheter ablations of cardiac arrhythmias are nowadays frequently guided by electro-anatomic mapping systems. Technical staff with medical training, or medical staff with technical training, is needed to assist the operator. Travel restrictions due to current COVID-19 pandemics have limited the in person availability for technical support staff. To overcome these limitations we explored the feasibility of remote support with an internet based communication platform.

A total of 9 patients (87,5% male, mean age 66,6 years) with different arrhythmias (atrial fibrillation, left atrial flutter, typical right atrial flutter, left ventricular tachycardia), having undergone ablation procedures between October 2020 and February 2021, were included. Acute procedural success was obtained in 9 out of 9 procedures. No complications occurred.

Our experience with remote support for electro-anatomic mapping for complex electrophysiological ablation procedures, show the feasibility and safety of this approach. It increases the availability of technical support at reduced costs and a reduced CO2 footprint. Remote support for electro-anatomic mapping may therefore facilitate continuous care for patients with arrhythmias during the COVID-19 pandemics. Due to its advantages beyond COVID-19 pandemics related problems, it will likely play a greater role in the future.

Funding Acknowledgement

Type of funding sources: None.