bluuebunny/crossref_metadata_2025 huggingface dataset:
Usefulness of a new risk score in identifying patients with CML at increased risk of cardiovascular toxicities
Authors: Alagna G , Di Lisi D , Santoro M , Accurso V , Madaudo C , Calcullo D , Siragusa S M , Galassi A R , Novo G
Published: October 2021

Background

Anti-BCR-ABL tyrosine kinase inhibitors (TKIs) dramatically improved the prognosis of patients with Chronic Myeloid Leukemia (CML) however they have been associated with cardiovascular (CV) complications.

Purpose

The primary aim of our study was to compare the usefulness of two different tools to stratify the risk of developing cardiovascular adverse events in haematology patients treated with ponatinib or nilotinib.

Methods

A real-life retrospective observational study was carried out on 58 patients (32 M, 26 W; mean age ± SD: 59±15) affected by CML treated with TKIs for a median period of 43±31 months. Patients were divided in groups according to CV risk estimated with SCORE and the 2020 CV risk assessment proposed by the Cardio-Oncology Study Group of the ESC/ICOS. Cardiac evaluation and echocardiogram were performed in all patients. The recorded CV adverse events were: myocardial ischemia, peripheral vascular diseases, new-onset or progression of preexisting carotid atherosclerosis, arterial hypertension, arrhythmias.

Results

According to SCORE, 46% of patients were at high-very high risk (group A1) and 54% at low-moderate risk (group B1). Applying the ESC/ICOS risk stratification tools, 60% were at high-very high risk (group A2) and 40% at low-medium risk (group B2). 21 CV adverse events were observed. CV adverse events were significantly more frequent in group A1 than group B1 (p value = 0,0003) when considered overall, they were significantly more frequent in group A2 than group B2 either overall (p=0,0004) or considered individually (myocardial ischemia: p=0,01; peripheral arterial disease: p=0,03). See Table 1. Moreover, the ESC/ICOS risk stratification tools was significantly more sensitive than SCORE (p=0,0004) in identifying patients at higher risk of cardiovascular toxicity. See Table 2.

No patients treated with Ponatinib showed CV adverse events during follow up. It is worth of notice that all patients before starting treatment underwent cardio-oncological evaluation, risk factors correction and preventive treatment with aspirin. They also were treated with the lowest dose of TKI. None of the patients treated with nilotinib over 4 years and with multiple lines of therapy, experiencing adverse events, received aspirin in primary prevention.

Conclusions

Our study shows that the ESC/ICOS risk stratification tools is very sensitive and more performing than SCORE for risk stratification of cardiotoxicity in haematology patients treated with TKIs. It also suggests that baseline CV risk assessment, CV risk factors correction and preventive treatment with aspirin aid in reducing CV adverse events in patients treated with ponatinib.

Funding Acknowledgement

Type of funding sources: None. Table 1Table 2
Long-term prognosis after ST-elevation myocardial infarction in cancer patients
Authors: Heemelaar J C , Polomski E A S , Mertens B J A , Jukema J W , Schalij M J , Antoni M L
Published: October 2021

Purpose

To assess survival trends after ST-elevation myocardial infarction (STEMI) in patients with a prior cancer diagnosis and to evaluate the drivers of prognosis over a follow-up period of five years.

Methods

Patients with a known cancer diagnosis, admitted with STEMI between 2004–2014 and treated with primary PCI were recruited from the STEMI-clinical registry of our institution. Detailed information on cancer diagnosis, -stage, and treatment regimen were collected from the institutional and national cancer registry system and all patients were followed prospectively.

Results

In the 215 included patients the cumulative incidence of all-cause death after 5 years of follow-up was 38.2% (N=61). The cause of death was predominantly malignancy-related (N=29, 47.4% of deaths) and only 9 patients (14.8% of deaths) died of a cardiovascular cause.

After correcting for age and sex – a recent cancer diagnosis (<1yr relative to >10 yr, HR 3.405 [95% CI: 1.552–7.470], p=0.002), distant metastasis at presentation (HR 2.603 [1.236–5.481], p=0.012), ongoing cancer treatment at presentation (HR 1.878 [1.015–3.475], p=0.045) and natural logarithm of maximum creatinine kinase level (HR 1.345 [1.044–1.733], p=0.022) were significant predictors of long-term mortality.

While prevalent renal insufficiency showed significant association with all-cause mortality (HR 2.302 [1.289–4.111], p=0.005), other known determinants of long-term prognosis after STEMI – a history of diabetes mellitus (HR 1.250 [0.566–2.761], p=0.581), hypertension (HR 0.623 [0.393–1.085], p=0.150), and culprit vessel left anterior descending artery or left main artery (HR 1.066 [0.641–1.771], p=0.806) were not significantly associated with survival at 5-years follow-up.

Conclusion

Cancer patients admitted with STEMI have a poor survival with one third of patients died at 5 year follow up. Cancer was the most common cause of death and malignancy-related factors made a significant impact on prognosis, while most of the established cardiovascular determinants of prognosis were not significantly associated with long-term survival.

Funding Acknowledgement

Type of funding sources: None. Cumulative incidence curve
Pregnancy in women with bicuspid aortic valve
Authors: Belkadi S , Milleron O , Eliahou L , Arnoult F , Delorme G , Ould Ouali N , Jadoui S , Jondeau G
Published: October 2021

Background

Aortic dissection during pregnancy is uncommon, however, the risk of aortic dissection is increased if there is underlying aortopathy. Bicuspid aortic valve (BAV) is common in the general population and is associated with the presence of an aortic aneurysm, but this condition is mostly asymptomatic and ignored in women of childbearing age. Data on pregnancy in patients with BAV are scarce, and guidelines on this topic are based on the consensus opinion of experts. The risk of occurrence of aortic dissection as a function of aortic diameter during pregnancy remains poorly known in women with BAV.

Purpose

To investigate demographic and echocardiographic characteristics and aortic events associated with pregnancy in women with BAV and to estimate ascending aortic diameter at the time of pregnancy.

Methods

We performed a retrospective study using data from our tertiary centre. All women seen at our centre between 1996 and 2020 with BAV, at least 1 pregnancy, and no genetic syndrome were included. We have collected data from echocardiograms performed in and out of our centre and aortic events.

Assuming from the literature an annual aortic dilation rate of 0.2 mm at the sinus of Valsalva and 0.4 mm at the tubular ascending aorta, we estimated ascending aortic size and Z-score at the time of pregnancy.

Results

We identified 47 women with BAV with occurrence of 103 pregnancies. The median age of BAV diagnosis was 43 years. The aorta was measured at a median of 13.3 years since the last delivery. At BAV diagnosis, the median largest ascending aortic diameter was 44mm, and the median Z-score was +4.3. Ascending aortic diameter was ≥40mm in 37/47 (79%) and Z-score ≥2 in 44/47 (94%).

No aortic dissection was observed during pregnancy and postpartum in all 103 pregnancies.

At the time of pregnancy, the estimated median diameter of the ascending aorta was 37mm and the estimated median Z-score was +3.3. The largest aortic diameter during pregnancy was estimated to be ≥40mm in 36/103 pregnancies, ≥45mm in 13/103, and ≥50mm in 1/103; Z-score was estimated to be ≥2 in 81/103 and ≥4 in 40/103.

Type A aortic dissection occurred in 1 woman, 13 years after pregnancy, and type B aortic dissection in 1 woman, 14 years after pregnancy. Planned surgery was performed in 8 women at a median of 17.5 years after the last pregnancy: 1 isolated aortic valve replacement and 7 prophylactic aortic surgeries associated with aortic valve surgery.

Conclusions

In our population of women with BAV, pregnancy is not associated with the occurrence of aortic dissection even though, when estimating aortic diameter at the time of pregnancy, the rate of aortic dilation was high (Z-score ≥2 in 81/103 pregnancies). Prospective studies of a large population of women with BAV are needed to assess the risk of aortic complication during pregnancy according to aortic diameter.

Funding Acknowledgement

Type of funding sources: None.
Long term prognostic utility of exercise capacity in renal transplant candidates
Authors: Tan S , Thang Y W , Mulley W R , Polkinghorne K , Ramkumar S , Cheng K , Rehmani H , Brown A J , Moir S , Cameron J D , Nicholls S J , Mottram P M , Nerlekar N
Published: October 2021

Background

Pharmacological stress testing is commonly performed for cardiovascular risk stratification in potential renal transplant candidates due to a perceived inability for these patients to exercise. We have previously reported that exercise stress testing is feasible in renal transplant candidates but the prognostic utility of exercise capacity in this patient group is not known.

Purpose

This study prospectively evaluated the effect of exercise capacity on the risk of major adverse cardiovascular events (MACE), defined as a composite of cardiac death, non-fatal myocardial infarction, and stroke, in renal transplant candidates undergoing exercise stress echocardiography (ESE) for pre-transplant cardiovascular assessment.

Methods

We evaluated 898 consecutive patients with chronic kidney disease stage 4/5 who underwent symptom-limited treadmill ESE over 5-year mean follow-up. Exercise capacity was measured by age and sex predicted metabolic equivalents (METs). The primary outcome was achievement of predicted METs with first MACE. Cox proportional hazard multivariable modelling was used to determine MACE predictors with transplantation treated as a time-varying covariate. We also performed secondary analysis using a 7 MET threshold.

Results

There were 106 MACE with an annual cumulative risk of 2.4%. During follow-up, 525 (58%) received transplantation. Achievement of predicted METs (48%) (hazard ratio (HR) 0.49, 95% confidence interval (CI) 0.29–0.82, p=0.007) and transplantation (HR 0.52, 95% CI 0.30–0.91, p=0.02) were independently associated with reduced MACE. Similar results were observed using a 7 MET threshold achieved by 734 (82%) patients. Patients achieving predicted METs had no difference in MACE regardless of subsequent transplantation (HR 0.78, 95% CI 0.32–1.92, p=0.59). Patients who achieved predicted METs and did not receive transplantation had similar outcomes to those that did not achieve predicted METs and received transplantation (HR 0.97, 95% CI 0.42–2.25, p=0.95).

Conclusions

Exercise capacity is associated with reduced long-term MACE in renal transplant candidates undergoing ESE for pre-transplant cardiovascular assessment. Achievement of age and sex predicted METs confers excellent prognosis independent of subsequent transplantation.

Funding Acknowledgement

Type of funding sources: None.
Prevention of contrast-induced nephropathy with urine alkalinization: the TEATE study
Authors: Lombardi M , Molisana M , Genovesi E , De Innocentiis C , Limbruno U , Misuraca L , Di Vito L , Zimarino M , Renda G , Di Nicola M , De Caterina R
Published: October 2021

Background

Contrast-induced acute kidney injury (CI-AKI) after coronary angiography and percutaneous interventions (PCI) impacts on hospitalization duration and mortality. Pre-procedural hydration is the sole strategy currently recommended for preventing CI-AKI. The role of sodium bicarbonate (SB) although attractive, since urine alkalinization suppresses the production of reactive oxygen species, is still controversial, and the optimal dosing to attain adequate urine alkalinization is still undefined.

Purpose

The PrevenTion of contrast-inducEd nephropathy with urine alkalinization (TEATE) study was a prospective 3-center 3-arm single-blind randomized controlled trial testing the hypothesis that adequate urine alkalinization is associated with CI-AKI prevention. Secondary endpoints were the efficacy of SB vs saline in achieving adequate urine alkalinization and reducing the incidence of CI-AKI compared with saline.

Methods

Patients candidate to coronary angiography and/or PCI with moderate-to-severe chronic kidney disease [eGFR of 15 to 60 mL/min/1.73 m2, by the Modification of Diet in Renal Disease Study equation (MDRD)] were randomly assigned to saline hydration (control), oral SB or i.v. SB. The study protocol was registered. We evaluated urinary pH at the time of hospitalization, immediately before coronary angiography and 24–48 hours after angiography. According to urine pH immediately before the procedure, patients were divided in two groups above or below a pH cut-off of 6.

Results

We enrolled a total of 241 patients: 81 were randomly assigned to the control group, 82 to i.v. SB and 78 to oral SB. Patients achieving a urinary pH >6 before angiography had a lower incidence of CI-AKI (46%) than patients with urinary pH ≤6 (54%) [OR=0.48 (95% CI 0.25–0.9) p=0.023]. The number of patients with urine pH >6 was higher in both the i.v. (71%) and the oral SB (65%) groups compared to the hydration-only group (44%, p=0.004). We found however no difference in the incidence of CI-AKI in the 3 treatment arms (20% in hydration alone, 21% in oral SB group and 22% in iv SB group) (p=0.94). Subgroup analyses according to basal urine pH and eGFR ranges failed to identify statistically significant differences in the development of CI-AKI according to treatment allocation.

Conclusions

Urinary pH before the administration of contrast medium is an inverse correlate of CI-AKI incidence, and SB is superior to hydration alone in achieving urinary alkalinization. Since, however, SB did not reduce the incidence of CI-AKI, we conclude that urinary pH is a marker and not a mediator of CI-AKI.

Funding Acknowledgement

Type of funding sources: None.
PCSK9 inhibitor therapy and guideline treatment targets for cardiovascular disease and familial hypercholesterolaemia
Authors: Suresh A , Theodoraki A , Ward E , Feher M D
Published: October 2021

Background

Updated trial data on the benefits of low-density lipoprotein cholesterol (LDL-C) reduction on cardiovascular outcomes have been incorporated into 2019 ESC/EAS guidelines and 2020 UK-based NICE guidance. Treatment targets for secondary cardiovascular disease (CVD) prevention are LDL-C <1.4mmol/L (ESC/EAS) and non-high-density lipoprotein <2.5mmol/L (equates to LDL-C <1.8mmol/L; NICE). Guidelines also recommend ≥50% LDL-C reduction in patients with CVD or Familial Hypercholesterolaemia (FH). Targets are often not achieved with oral statin +/− ezetimibe due to reduced efficacy or tolerability, warranting a switch to PCSK9 inhibitor therapy. However, there is limited data on whether this achieves LDL-C targets for both CVD and FH in real world clinical practice.

Purpose

To assess attainment of LDL-C treatment targets using PCSK9 inhibitor mono- or combination therapy in routine clinical care for patients with FH or CVD.

Methods

Observational study in a single specialist lipid clinic, using retrospective case note review of patients prescribed PCSK9 inhibitor therapy according to NICE guidelines until February 2021. Anonymised clinical, demographic and biochemical data before and after commencement of PCSK9 inhibitor therapy were collected. Primary outcomes were attainment of guideline-defined LDL-C treatment targets: LDL-C <1.8 mmol/L, LDL-C <1.4mmol/L and ≥50% LDL-C reduction.

Results

A total of 55 patients (mean age 60.8±12.9 years, 58% male) on PCSK9 inhibitor therapy (98% alirocumab, 2% evolocumab; mean treatment duration 1.7±1.3 years) were identified. PCSK9 inhibitor therapy was commenced due to drug intolerance to statins (89%), ezetimibe (36%) and fenofibrate (25%). In patients with FH (n=18), 78%, 56% and 33% of patients achieved targets of ≥50% LDL-C reduction, LDL-C <1.8 mmol/L and LDL-C <1.4 mmol/L on treatment, respectively. In CVD patients (n=49), 84%, 51% and 27% achieved the same targets respectively (Table 1). In patients on PCSK9 inhibitor monotherapy (n=19), 21% and 5% achieved LDL-C targets <1.8 mmol/L and <1.4 mmol/L respectively, whereas in those on PCSK9 inhibitor + two or more additional oral lipid-lowering therapies, 87% and 60% achieved the same targets respectively (Table 2).

Conclusions

Most patients with FH or CVD achieve an LDL-C reduction of ≥50% from baseline with PCSK9 inhibitor therapy, however fewer achieve the LDL-C targets of <1.8 mmol/L or <1.4 mmol/L. Patients on PCSK9 inhibitor monotherapy are unlikely to reach LDL-C <1.8 mmol/L and <1.4mmol/L targets, whereas PCSK9 inhibitor combination therapies are more likely to do so. Additional lipid-lowering drugs are required with PCSK9 inhibitor therapy in most patients to reach guideline LDL-C targets.

Funding Acknowledgement

Type of funding sources: None.
Meta-analysis of cardiovascular outcome trials assessing the impact of glucagon-like peptide-1 receptor agonists on major cardiac arrhythmias
Authors: Boulmpou A , Patoulias D , Teperikidis E , Toumpourleka M , Vergopoulos S , Tsavousoglou C , Doumas M , Fragakis N , Vassilikos V , Papadopoulos C E
Published: October 2021

Background

Type 2 diabetes mellitus poses a significant health burden, whereas growing attention has been focused on the novel classes of antidiabetic drugs. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) constitute such a group of antidiabetic agents. In recent large, placebo-controlled randomized clinical trials (RCTs), GLP-1RAs have demonstrated beneficial cardiovascular effects. Nevertheless, the clear antiarrhythmic benefit has not been underlined yet.

Purpose

The purpose of the present analysis was to clarify the impact of antidiabetic treatment with GLP-1RAs on the several different types of cardiac arrhythmias, based on data extracted from relevant cardiovascular outcome trials.

Methods

We searched PubMed plus grey literature for all available cardiovascular and renal outcome, placebo-controlled RCTs utilizing GLP-1RAs versus placebo.

Results

We pooled data from 7 cardiovascular outcome trials with GLP-1RAs in a total of 55,943 randomized participants patients. When compared to placebo, treatment with GLP-1RAs did not provide a significant benefit in the risk for atrial fibrillation (RR = 0.81, 95% CI: 0.78–1.15, I2=51%) (Figure 1a), atrial flutter (RR=0.79, 95% CI: 0.53–1.16, I2=0%) (Figure 1b), ventricular fibrillation (RR=0.99, 95% CI: 0.48–2.04, I2=0%) (Figure 1c), ventricular tachycardia (RR=1.41, 95% CI: 0.87–2.28, I2=10%) (Figure 1d), atrial tachycardia (RR=0.63, 95% CI: 0.10–3.90, I2=24%) (Figure 2a), sinus node dysfunction (RR=0.70, 95% CI: 0.40–1.23, I2=0%) (Figure 2b), ventricular extrasystoles (RR=1.37, 95% CI: 0.56–3.30, I2=0%) (Figure 2c), second-degree atrioventricular block (RR=0.96, 95% CI: 0.52–1.74, I2=0%) (Figure 2d) or complete atrioventricular block (RR=0.78, 95% CI: 0.39–1.54, I2=38%) (Figure 2e).

Conclusions

In patients with type 2 diabetes mellitus, treatment with GLP-1RAs does not significantly affect the risk for major cardiac arrhythmias.

Funding Acknowledgement

Type of funding sources: None. Figure 1Figure 2
Cardio-renal protective effects of SGLT2 inhibitors in patients with type 2 diabetes mellitus and severely impaired renal function
Authors: Kanai M , Kimura K , Motoki H , Suzuki S , Okano T , Minamisawa M , Yoshie K , Kato T , Saigusa T , Ebisawa S , Okada A , Kuwahara K
Published: October 2021

Background

Prognostic impact of Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors on cardiovascular and renal outcome was unknown in patients with type-2 diabetes mellitus (DM) and severely impaired renal function.

Methods

From July 2015 to December 2020, patients with type-2 DM who were taken SGLT2 inhibitors for more than six months were retrospectively screened. Patients with estimated glomerular filtration rate (eGFR) over 60ml/min/1.73m2 were excluded. We divided those patients into two groups by eGFR; less than 45ml/min/1,73m2 were group A and 46–60ml/min/m2 were group B. Randomly selected patients with DM not taking SGLT2 inhibitors and having severe renal dysfunction: eGFR less than 45ml/min/m2 (Group C) were set as controls. The primary outcome was a composite of cardiovascular/renal death, initiation of dialysis, doubling of the serum creatine level, decline in the eGFR more than 30%, nonfatal myocardial infraction, nonfatal stroke, and hospitalization for heart failure.

Results

Totally 418 patients were enrolled. Median age was 71 years (group A, n=106), 64 years (group B, n=115), and 77 years (group C, n=201) (p<0.001). After median 24 months follow-up, primary endpoints were observed 24.5% in group A, 4.3% in group B, 36.8% in group C (p<0.001). In Kaplan-Meier analysis, significantly lower incidence of primary endpoints were observed in SGLT2 groups (group A and B) than controls (p<0.001, Figure 1). In patients with severe renal dysfunction, taking SGLT2 inhibitors tended to decrease future renal event (Figure 2). The incidence of SGLT2 related adverse events was not different between 2 groups (A and B).

Conclusions

Even in patients with severe renal dysfunction, SGLT2 inhibitors would have cardio-renal protective effects without drug-related adverse effects.

Funding Acknowledgement

Type of funding sources: None.
Potential risks of substituting estimated glomerular filtration rate for estimated creatinine clearance for dosing of direct oral anticoagulants in atrial fibrillation and chronic kidney disease
Authors: Vaclavik J , Kalina M , Hodacova M , Kryza J , Janusova L
Published: October 2021

Background

In the clinical trials with direct oral anticoagulants (DOAC) estimates of creatinine clearance (CrCl) with Cockcroft-Gault equation were used to assess renal functions. Recently, most laboratories report renal function estimated with the Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations, which may lead to impaired dosing of DOACs by physicians.

Purpose

To compare estimated glomerular filtration rate and estimated creatinine clearance in a large group of patients with atrial fibrillation and chronic kidney disease.

Methods

Physicians from 423 institutions in the Czech Republic were asked to enroll 5 consecutive outpatients with atrial fibrillation (AF) treated by a DOAC with stage 3 chronic kidney disease and glomerular filtration rate (eGFR) 30–59 ml/min estimated by MDRD or CKD EPI equations into the registry. Besides eGFR, serum creatinine values were recorded and CrCl calculated by the Cockroft-Gault formula. Results of CrCl and eGFR obtained in individual patients were compared and statistically analyzed using two-sample t-test.

Results

A total of 2115 patients were enrolled. Mean CrCl was 47.43 ml/min, mean eGFR calculated by MDRD and CKD-EPI was lower 43.88 and 43.53 ml/min (P for difference <0.001 for both). Mean difference between CrCl and eGFR in individual patients calculated by MDRD and CKD-EPI was 8.8 and 9.41 ml/min. A difference beween CrCl and eGFR >10 ml/min was found in 31.5% and 34.8% patients when using MDRD and CKD-EPI formulas. The respective differences between CrCl and eGFR between 4.1 and 10 ml/min were found in 28.5% (MDRD) and 30.8% (CKD-EPI). At CrCl above or below 50 ml/min, 24.0% and 24.2% were misclassified when using eGFR calculated by MDRD and CKD-EPI. At CrCl above or below 30 ml/min, 9.8% (MDRD) and 10.0% (CKD-EPI) patients were misclassified (please see Figures).

Conclusions

When eGFR estimated by MDRD or CKD-EPI is used to assess renal function and guide DOAC dosing instead of CrCl calculated by the Cockroft-Gault formula in patients with AF and stage 3 CKD, more than a third of patients is misclassified and wrong DOAC dose can be recommended.

Funding Acknowledgement

Type of funding sources: Private company. Main funding source(s): Boehringer-Ingelheim Differences between CrCl and CKD-EPIDifferences between CrCl and MDRD
Management and impact of atrial fibrillation in the COVID 19 era; concomitancy of two procoagulant phenomena
Authors: Arteagoitia A , Monteagudo J M , Antonana S , Gonzalez A , Ortega R , Rivas S , Martinez-Moya R R , Sanroman M A , Lorente-Ros A , Rincon L M , Zamorano J L
Published: October 2021

Background

Atrial fibrillation (AF) is a widespread cause of prothrombotic state leading to long-term anticoagulant therapy. Literature describes coagulopathy as a key pathogenic mechanism of COVID-19 disease. Thus, antithrombotic therapy management is still a therapeutic challenge. During hospitalization, changing oral anticoagulant (OAC) therapies into subcutaneous heparin is common in daily clinical practice.

Purpose

The primary endpoint of this study is to analyze the impact of AF in mortality within 30 day since admission of COVID-19 patients. The secondary endpoint is to analyze the impact of the anticoagulant therapy strategy (therapeutic dose of subcutaneous heparin vs. OAC) in 30-day mortality of hospitalized COVID-19 patients with AF.

Methods

A total of 1001 consecutive patients hospitalized in our centre between 22nd August and 9th January 2021 with a confirmed microbiological diagnosis of COVID-19 by PCR were prospectively included. Of them, 134 had a previous diagnose of AF (13.5%). Cox regression analysis was performed to assess the impact of AF and the choice of anticoagulant therapy in 30-day mortality after adjusting for comorbidity (Charlson Comorbidity Index).

Results

After adjusting for comorbidities, AF was not independently associated with a higher 30-day mortality in patients hospitalized due to COVID-19 infection (HR 1.04, CI 0.77–1.43, p=0.760). In the group of patients with AF, changing OAC to heparin therapy was not associated with an improved prognosis (HR 0.85, CI 95% 0.46–1.56, p=0.604).

Conclusions

AF is not an independent prognostic factor in COVID-19 hospitalized patients. In hospitalized COVID-19 patients with AF, changing OAC to heparin therapy is not related to an improved prognosis.

Funding Acknowledgement

Type of funding sources: None. Mortality heparin vs NOAC or AVK
Direct oral anticoagulants compared with vitamin K antagonists for left ventricular thrombi systematic review and meta-analysis
Authors: Costa G , Saleiro C , Neto V , Goncalves L , Teixeira R
Published: October 2021

Background

Left ventricular thrombus (LVT) is a serious complication primarily occurring in patients with LV dysfunction following large myocardial infarction. The role of direct oral anticoagulants in this clinical setting remains controversial.

Purpose

To compare DOACs versus vitamin K antagonists (VKA) in LVT treatment.

Methods

We systematically searched PubMed, Embase and Cochrane databases, in February 2020, for interventional or observational studies comparing DOAC with VKA on LVT treatment.

Results

Fourteen publications were included, nine published studies and five conference abstracts, providing 1899 patients, 490 patients on DOACs and 1409 subjects on VKA. In terms of efficacy, DOAC had a lower LVT resolution for all studies included which reported LVT resolution (pooled OR, 0.73; 95% CI, 0.55–0.98; P=0.04; I2=52%), but sensitivity analysis revealed no difference between anticoagulant strategy (pooled OR, 0.78; 95% CI, 0.57–1.05; P=0.10; I2=59%). In terms of systemic embolism or stroke, DOAC had a similar efficacy (pooled OR, 1.06; 95% CI, 0.69–1.63; P=0.78; I2=30%) compared to VKA. In clinically relevant bleeding events analysis, the anticoagulation strategy did not differ in the odds of bleeding (pooled OR, 0.65; 95% CI, 0.37–1.15 P=0.14; I2=0%), with similar findings in net adverse clinical events analysis (pooled OR, 0.66; 95% CI, 0.35–1.25; I2=54%; P=0.20).

Conclusion

Our pooled data suggests DOACs as a safe approach to LVT, despite inconsistent efficacy on LVT resolution.

Funding Acknowledgement

Type of funding sources: None.
Meta-analysis of clinical trials comparing triple versus dual antithrombotic therapy on risk reduction of stent thrombosis after percutaneous coronary intervention in atrial fibrillation patients
Authors: Shams S S , Assaf O , Basir A B , Choudhury T C , Wong K W
Published: October 2021

Background

Coronary artery disease (CAD) is a leading cause of mortality worldwide. Atrial fibrillation (AF) and CAD frequently coexist. Patients with acute coronary syndrome (ACS) requiring percutaneous coronary intervention (PCI) are treated with dual antiplatelet therapy (DAPT) - i.e., aspirin and P2Y12 inhibitor- to prevent stent thrombosis (ST) and recurrent myocardial infarction (MI). Patients with AF and CAD are at risk of stroke. Stroke risk is reduced with oral anticoagulant therapy (warfarin) or one of the direct oral anticoagulant agents (DOACs). Patients treated with triple antithrombotic therapy (TAT)- i.e., DAPT plus oral anticoagulant therapy- suffer higher risk of major or clinically significant bleeding compared with DAT (P2Y12 and DOAC). This appeared to be statistically significant in most but not all of the randomised controlled trials (RCTs). However, it is unclear whether the risk of stent thrombosis/MI might be higher in patients treated with DAT. Previous meta-analyses have yielded conflicting conclusions.

Purpose

To determine the optimum antithrombotic therapy for patients with AF and CAD requiring PCI and/or ACS regarding the incidence of myocardial infarction or stent thrombosis.

Methods

A comprehensive literature search was done identifying all RCTs on the efficacy of antithrombotic therapy in patients with AF and ACS or PCI. A meta-analysis was performed to test the hypothesis that TAT significantly reduces the risk of stent thrombosis (ST) and MI.

Results

A total of 11,542 patients were included in the 5 RCTs, comparing TAT vs DAT – i.e., WOEST Trial 2013 [1], PIONEER AF-PCI 2016 [2], RE-DUAL PCI 2017 [3], ENTRUST-AF PCI 2019 [4], AUGUSTUS 2019 [5]. Triple therapy did not lead to significant reduction in risk of Myocardial Infarction (MI) [risk ratio (RR) 0.85, 95% CI 0.69–1.04, P=0.12], or Stent Thrombosis (RR 0.76, 95% CI 0.51–1.12, P=0.16). [Figure 1] On the other hand, the risk of major bleeding or clinically significant bleeding is significantly lower with DAT [Figure 2].

Conclusion

DAT comprising of warfarin or DOAC and P2Y12 inhibitor reduced risk of major or clinically significant bleeding without increasing the risk of ST or recurrent MI as compared to TAT. The results encourage the use of DAT rather than TAT in patients with ACS and/or patients requiring PCI with AF who require combined antiplatelet and anticoagulant therapy.

Funding Acknowledgement

Type of funding sources: None. Major bleeding risk
The relationship between comorbidities and physical activity and kinesiophobia of patients with heart rhythm disorders in Covid-19 pandemia
Authors: Saklica D , Vardar-Yagli N , Sener Y Z , Ates A H , Yorgun H , Aytemir K
Published: October 2021

Background/Introduction

Covid-19 disease, which affects more than 128 million people worldwide, has caused changes in lifestyle and physical activity habits in patients with cardiovascular disease due to lockdown restrictions. During the pandemic period, patients with chronic diseases (also patients with comorbidities) cannot participate in physical activity and exercise programs due to social isolation.

Purpose

The aim of our study is to investigate the relationship between the comorbidities of heart rhythm disorder patients and their physical activity levels and kinesophobia in the Covid-19 pandemic.

Methods

105 individuals (54 healthy adults, 51 patients with heart rhythm disorders) were included in this study.

Physical Activity Level: Physical activity level was evaluated using the International Physical Activity Questionnaire-Short Form (IPAQ-SF).

Fear of Movement: Fear of movement was evaluated using the Tampa Scale of Kinesiophobia for Heart.

The Comorbid Conditions: The comorbid conditions of the patients were evaluated by the Charlson comorbidity index.

Results

Table 1. In patients with heart rhythm disorders, there was a negative, moderate correlation between the Charlson comorbidity index and the number of daily steps (r=−402, p=0.03), while a positive, moderate relationship with the Charlson comorbidity index and Tampa score (r=391, p=0.05) has been found.

Conclusion

While the Charlson comorbidity index value and Tampa Score were higher in patients with heart rhythm disorders than in the control group, the number of inactive patients among the subgroups of the IPAQ-SF scale was higher than the control group.

While heart rhythm disorders patients with more comorbidities are more prone to develop kinesiophobia, the number of daily steps decreases in the same direction.

Management of comorbidities of patients with heart rhythm disorders can be provided by physical activity counseling to these people.

Funding Acknowledgement

Type of funding sources: None.
The possibility of determining the systolic function of the left ventricle using a single-channel electrocardiogram monitor with photoplethysmography
Authors: Sagirova Z H N , Kuznetsova N O , Gogiberidze N A , Gognieva D G , Chomakhidze P S H , Kopylov P H Y U
Published: October 2021

Introduction

Assessment of the systolic function of the left ventricle is the basis for the timely diagnosis and treatment of various diseases of the cardiovascular system. Regular monitoring of the systolic function is very often necessary. Remote assessment of the left ventricular systolic function can provide more thorough and convenient monitoring of the patient's condition.

Purpose

The determination of the left ventricular systolic function using a single-channel electrocardiogram (ECG) monitor with photoplethysmography function.

Methods

The study prospectively included 400 patients aged 18 and over with various pathologies of the cardiovascular system. All study participants underwent echocardiography and the indicators of the left ventricular (LV) systolic function were determined: LV ejection fraction (LV EF), LV outflow tract velocity time integral (LVOT VTI). Recording of the electrocardiogram (I standard lead) and the photoplethysmogram (PPG) using a single-channel ECG monitor with photoplethysmography were performed in all patients. The single-channel electrocardiogram monitor is a portable electrocardiograph with photoplethysmography in the form of a smartphone case. The ECG and PPG parameters were calculated and compared with echocardiography. Models for assessing the LV systolic function were built based on the obtained ECG and PPG parameters using the random forest algorithm.

Results

A total of 400 ECG records and 400 PPG records were obtained. Then the parameters ECG and PPG were selected for constructing the models. We obtained three models for the ejection fraction (less than 55%, less than 40%, less than 30%) and two models for the LVOT VTI. The quality of each model was assessed by sensitivity, specificity, area under the ROC curve (AUC). For the model with the ejection fraction less than 55%, the AUC was 91.3% (0.844–0.982), sensitivity – 86.4%, specificity – 91.4%. AUC was 95.5% (0.903–1.000), sensitivity 100%, specificity 87.2% for the model with the ejection fraction less than 40%. For the model with the ejection fraction less than 30% AUC: 96.2% (0.900–1.000), sensitivity 100%, specificity 92.9%. Models for the LVOT VTI: less than 13cm (AUC: 77.6% (0.561–0.992), sensitivity 80%, specificity 78.1%) and less than 16cm (AUC: 78.2% (0.657–0.907), sensitivity 76.5%, specificity 77.4%).

Conclusions

The models obtained based on ECG and PPG parameters had sufficiently high accuracy. Thus, using the ECG and PPG, it is possible to assess the LV systolic function. Therefore, it will be possible to perform the remote monitoring of the systolic function of the left ventricle using portable the single-channel electrocardiogram monitor with photoplethysmography.

Funding Acknowledgement

Type of funding sources: None.
Rapid rollout of a pacemaker home monitoring service during the 2020 COVID-19 pandemic
Authors: Shurlock J , Gratton B , Wilson L , Heatley R , Roach M , Dayer M , Furniss G
Published: October 2021

Introduction

In an effort to reduce non-essential face to face contact during the COVD pandemic our pacemaker service was restructured in March 2020 to home monitoring only. Home monitors were issued at implant and wound reviews were done remotely via photo messages at one month or if prompted by the patient. Existing patients were given monitors on an ad hoc basis. A dedicated physiologist worked off site on home monitoring clinics. We assessed the impact on our service and on patient experience of these changes one year after implementation.

Methods

Baseline characteristics of age at implant and distance of home address from hospital were collected from all patients undergoing pacemaker home monitoring. Patients were surveyed using an adapted version of the Generic Short Patient Experiences Questionnaire (GS-PEQ). Comparison was made with our standard face-to-face follow-up model (1, 3, and 12 months).

Results

Data was collected for 326 patients. 233 received a new permanent pacemaker from March 2020 onwards and 93 existing patients were issued with a home monitor. Average age at pacemaker implant was 80.6 years (±9.9 years). The average one-way distance from home to outpatient clinic saved was 15.1 miles (±10.4 miles). 567 face-to-face appointments were saved. On an average day the off-site physiologist reviewed over 100 patient records a day, contacted 10 patients by phone and dictated reports on 20 patients (14 clinic patients and 6 alerts).

Of patients surveyed 88% agreed with the statement “I feel safe being cared for solely with a remote monitoring service” and 84% agreed with the statement “I receive the same standard of care via remote monitoring and face-to-face appointments”. Time saved by avoiding a face to face appointment was more than 1 hour for 90% of respondents. Respondents requested communication of reassuring monitoring, the ability to contact the pacing team in the event of concerns and clearer instructions for the home monitoring device.

Only 34% of newly implanted patients were able to send a photo message of their wound without prompting. We did not get a post procedure photo in 38% and the rest either spoke to us about the wound or had a face-to face visit. There was a significant difference in mean age between those who sent a photo (73.7 years) and those who didn't (81.4 years) (P=0.0006).

Conclusion

Rapid role out of a remote monitoring service for permanent pacemakers across a large county was feasible, produced significant savings in clinic time and was well received by patients. There were significant time savings for physiologists and patients. However remote wound monitoring in elderly patients was problematic due to the difficulty of sending photo messages.

Funding Acknowledgement

Type of funding sources: None.
Implementation of cardiology tele-visits after COVID-19 pandemic: the INFO-COVID survey
Authors: Boriani G , Maisano A , Bonini N , Albini A , Imberti J F , Venturelli A , Camaioni G , Passiatore M , De Mitri G , Nanni G , Girolami D , Siena V , Sgreccia D , Valenti A C , Vitolo M
Published: October 2021

Background

During the COVID-19 pandemic, implementation of telemedicine has represented a new potential option for outpatient care.

Purpose

The aim of our study was to evaluate digital literacy among cardiology outpatients.

Methods

From March to June 2020 a survey on telehealth among cardiology outpatients was performed. Digital literacy was investigated through six main domains: age; sex; educational level; Internet access; availability of Internet sources; knowledge and use of teleconference software programs.

Results

The study included 1067 patients, median age 79 years, 41.3% females. The majority of the patients (58.0%) had a secondary school degree, but among patients aged ≥75 years old the most represented educational level was primary school or none. Overall, for Internet access, there was a splitting between “never” (42.1%) and “every day” (41.0%), while only 2.7% answered “at least 1/month” and 14.2% “at least 1/week”. In the total population, the most used devices for Internet access were smartphones (59.0%), and WhatsApp represented the most used app (57.3%). Internet users were younger compared to non-Internet users (63 versus 78 years old, respectively) and with a higher educational level. Age and educational level were associated with non-use of Internet (age-per 10-year increase odds ratio [OR] 3.07, 95% confidence interval [CI] 2.54–3.71, secondary school OR 0.18, 95% CI 0.12–0.26, university OR 0.05, 95% CI 0.02–0.10) (Figure 1).

Conclusions

Telemedicine represents an appealing option to implement medical practice, and for its development it is important to address the gaps in patients' digital skills, with age and educational level being key factors in this setting.

Funding Acknowledgement

Type of funding sources: None. Figure 1. Factors associated with Internet non-use
Insights into a regional collaboration for improving heart care across the complete care chain
Authors: Dekker L R C , Van Veghel D , Theunissen L J H , Janssen J H P , Burg M P , Van De Pol J A A , Cremers H P
Published: October 2021

Background

The Netherlands Heart Network is a joint-effort of all relevant healthcare providers in primary, secondary, and tertiary care across the complete care chain in a region with an adherence of approximately 1,000,000 inhabitants. This regional collaboration features four non-academic hospitals, over 450 general practitioners and various other healthcare professionals who cooperate for the continuous improvement of cardiac patient care using Value Based Healthcare principles.

Purpose

Due to predicted demographic changes and the expected rise of cardiovascular diseases, novel initiatives are needed to optimize present-day healthcare systems. Therefore, the NHN has focused on the implementation of transmural integrated care delivery systems and impactful innovations for four major cardiovascular diseases: atrial fibrillation (AF), heart failure (HF), coronary artery disease and valvular diseases.

Methods

Various new health care initiatives and innovations have been implemented and evaluated in the region. For example, dedicated outpatient clinics and transmural care standards have been implemented for AF and HF across the full care cycle. The effect of the implementation of these care standards on patient-relevant outcomes and healthcare costs has been evaluated using large scale prospective and retrospective quality registries. Furthermore, new health care innovations include, among others, the opportunistic screening for AF within general practices and an optimized pre-hospital triage protocol for NSTEMI patients.

Results

Patient-relevant outcomes in 446 AF patients who visited dedicated outpatient clinics improved within 6 months of follow-up (EHRA score (1.93 to 1.36; p<0.01), hypertension (55.4% to 52.7%; p<0.01) and persistent AF (30.1% to 12.5%; p<0.01)). The introduction of transmural care standards for HF led to significant improvements in patient-relevant outcomes when comparing data before and after implementation (NYHA class (X2=9.1; p=0,03) and LVEF (41.7% vs. 38.4%; p<0.01)) and a reduction of mean healthcare costs by 25%. Moreover, the results of various innovations, including the AF screening protocol and potential benefits of pre-hospital triage of NSTEMI patients, are currently being evaluated.

Conclusion(s)

This regional collaboration by health professionals is unique in its approach and highlights that healthcare improvements are not exclusively reserved to large academic centers or referral hospitals. The present approach may serve as a blueprint for the organization of healthcare in other regions.

Funding Acknowledgement

Type of funding sources: Public grant(s) – National budget only. Main funding source(s): ZonMWHealth insurance CZ/VGZ
Water hardness and its impact on arterial stiffness and carotid atherosclerotic burdens; insights from the 'Corinthia study'
Authors: Vogiatzi G , Oikonomou E , Lazaros G , Kostakis M , Kypritidou Z , Christoforatou E , Chasikidis C H , Mystakidi V , Theofilis P , Vavouranaki G , Goliopoulou A , Argyraki A , Thomaidis N , Tousoulis D
Published: October 2021

Introduction

It has been long investigated the potential role of water quality in cardiovascular health.

Purpose

The aim of this study was to examine the association between water hardness, arterial stiffness and atheromatic burden in carotid arteries.

Design and methods

Corinthia study is a cross-sectional epidemiological study conducted in subjects aged 40–99 years. Intima media thickness (IMT) was measured in the left and right common carotid artery, carotid bulb and internal carotid artery. The average of the measurements (mean IMT) and the maximum IMT were determined as the representative value of carotid atherosclerosis burden. Pulse wave velocity (PWV) was used to evaluate arterial stiffness. Tap-water samples were collected from the study area, and analyzed for major, minor and trace elements, as well as pH and total hardness.

Results

In this analysis we included data from 1.404 participants. In subjects consuming water with a hardness above 250mg/dL, especially in those above >65 years old maximum and mean IMT was significantly increased compared to those consuming water with a hardness above 250mg/dL (1.61mm vs. 1.34mm respectively, p<0.001 and 1.15mm vs. 1.05, p=0.005 for WH ≥250mg/dL and WH <250mg/dL, respectively). Similarly, the prevalence of atheromatic plaques was higher in subjects of the first category (15,2% vs. 7,6%, p=0.004). No differences emerged for the arterial stiffness in the individual subgroups. statistically significant correlation was revealed (p=0.004).

Conclusions

There seem to be a negative association between extra hard water and carotid atheromatic burden highlighting the possible impact of water quality in cardiovascular health.

Funding Acknowledgement

Type of funding sources: None. Table 1
Global representation of heart failure clinical trial leaders and collaborators: a systematic bibliometric review 2000–2020
Authors: Zhu J , Le N , Wei S , Zuhlke L , Lopes R , Zannad F , Van Spall H G C
Published: October 2021

Aims

Heart Failure (HF) has a disproportionate burden in low- and middle-income countries. The geographic representation of those who lead HF randomized clinical trials (RCTs) may not reflect the geographic burden of disease. We assessed temporal trends and trial characteristics associated with leadership outside Europe and North America, and explored whether there was a geographic association between trial leadership and participant enrolment.

Methods and results

We searched MEDLINE, EMBASE, and CINAHL for HF RCTs published in journals with an impact factor ≥10 between January 1, 2000, and June 17, 2020. We used the Jonckheere-Terpstra test to assess temporal trends and multivariable logistic regression models to determine associations between predictor and outcome variables.

There were 414 eligible RCTs. Only 80 of 828 trial leaders (9.7%; 95% CI: 7.8% to 11.8%), and 453 of 4656 collaborators (9.7%; 95% CI: 8.8% to 10.6%) were from regions outside Europe and North America, with no temporal change in geographic representation. The odds of trial leadership outside Europe and North America were significantly lower with industry versus public funding (OR: 0.33; 95% CI: 0.15 to 0.75; P=0.008). Trial leadership outside Europe and North America was associated with enrolment of patients outside Europe and North America (OR: 10.0; 95% CI 5.6–19.0; P<0.001).

Conclusion

Trial leadership outside Europe and North America is rare, particularly in industry funded trials, and is associated with participant enrolment in regions with disproportionate disease burden. Building research capacity and networks in under-represented regions could increase generalizability of trial results.

Funding Acknowledgement

Type of funding sources: None.