bluuebunny/crossref_metadata_2025 huggingface dataset:
Effects of semaglutide on functional capacity in patients with type 2 diabetes and peripheral arterial disease: rationale and design of the STRIDE trial
Authors: Sillesen H , Debus E S , Enggaard R B B , Frenkel O , Heled Y , Mansor-Lefebvre S , Bonaca M P
Published: October 2021

Background/Introduction

Lower extremity peripheral arterial disease (PAD) is a severe form of atherosclerotic cardiovascular (CV) disease. The classical symptom is intermittent claudication (IC), associated with limited walking ability and poor health-related quality of life (QoL). Type 2 diabetes (T2D) is one of the leading causes of PAD; ∼30% of patients with PAD have T2D. While anti-atherosclerotic drugs and lifestyle changes are recommended, there are no effective drugs to specifically improve functional outcomes in PAD and T2D. Semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1RA) approved as an adjunct to diet and exercise for glycaemic control in patients with T2D. In the T2D SUSTAIN clinical trial programme, once-weekly (OW) subcutaneous semaglutide 0.5 and 1.0 mg was superior for glycaemic control and weight loss vs placebo and a range of approved antidiabetic drugs. In SUSTAIN 6, a dedicated CV outcomes trial, OW semaglutide resulted in a 26% reduction in three-point major adverse CV events (MACE) compared with placebo in patients with T2D at high CV risk, leading to its approval for MACE risk reduction in those with T2D and CV disease in the USA. Evidence suggests this may be partly attributable to the anti-inflammatory and anti-atherosclerotic effects of semaglutide, which may also apply to PAD.

Purpose

The STRIDE trial will demonstrate the effect of OW semaglutide 1.0 mg vs placebo on walking ability in patients with T2D and PAD with IC.

Methods

STRIDE is a 52-week, randomised, double-blind, placebo-controlled, phase 3b trial. Trial design and eligibility criteria are shown in the Figure; ∼800 patients will be randomised 1:1 to OW semaglutide 1.0 mg or placebo, both added to standard of care. The primary endpoint is change in maximum walking distance on a constant load treadmill test from baseline to week 52. Secondary confirmatory endpoints include changes in pain-free walking distance and PAD-specific, health-related patient-reported outcomes (Vascular QoL Questionnaire-6) from baseline to week 52.

Results

The trial started in October 2020 and is currently recruiting, with ∼120 sites in ∼20 countries across Asia, Europe, and North America.

Conclusion

STRIDE is the first and only dedicated PAD outcomes trial with a GLP-1RA and thus presents a unique trial design. While major adverse limb events typically occur in the later stages of PAD, STRIDE instead measures the effect of OW semaglutide on functional outcomes such as walking ability and QoL, which affect everyday living in patients with PAD and IC. STRIDE data will provide important clinical insights regarding the role of OW semaglutide in patients with T2D and PAD.

Funding Acknowledgement

Type of funding sources: Private company. Main funding source(s): Novo Nordisk A/S
Real-world experience with the cusp overlap deployment technique for procedural optimization during self-expanding transcatheter aortic valve implantation: our city best practice trial
Authors: Maier O , Binneboessel S , Klein K , Piayda K , Polzin A , Westenfeld R , Jung C , Berisha N , Zeus T , Kelm M , Veulemans V
Published: October 2021

Background

Aortic valve stenosis treated by transcatheter aortic valve implantation (TAVI) is a fast-growing section in interventional cardiology. Optimal implantation depth (ID) of self-expanding TAVI devices is an important condition for hemodynamic and clinical outcomes. The cusp overlap technique (COT) offers optimized fluoroscopic projections for TAVI with self-expanding devices due to improved anatomic discrimination by elongation of the left ventricular outflow tract and isolation of the non-coronary cusp (NCC) for better assessment of ID.

Purpose

This single-center observational study aims to investigate short-term clinical performance, safety, and efficiency outcomes regarding optimized ID in patients undergoing transfemoral TAVI with self-expanding prostheses and COT.

Methods

From September 2020 to December 2020, a total of 71 patients underwent TAVI with a newer-generation self-expanding device and COT. The optimal fluoroscopic projection was generated by overlapping the right (RCC) and left coronary cusps (LCC) on the multidetector computed tomography annular plane. Final ID was assessed by the arithmetic mean of distances measured from NCC and LCC to the distal prosthesis end. Outcomes were compared with a control cohort of 339 patients who underwent TAVI from January 2016 to August 2020 with a three-cusp coplanar view only during valve deployment.

Results

ID was significantly reduced in the COT cohort (4.3±1.9 vs. 5.0±2.3 mm; p=0.012) with better achievement of optimal ID (2–4 mm) (63.4% vs. 49.9%; p=0.03) and optimization of delta NCC-LCC ID symmetry (1.4±1.3 vs. 1.7±1.3 mm; p=0.026). The rate of pacemaker implantation following TAVI could be reduced (9.9% vs. 19.4%; p=0.05). Six of the seven patients receiving pacemaker in the COT cohort (85.7%) showed ID above membranous septum length. COT resulted in notably higher rates of device repositioning by recapturing (57.8% vs. 16.2%; p<0.001) compared to control cohort. Though, procedure time was prolonged in the COT cohort (82.0±26.5 vs. 74.9±27.5 min; p=0.05) while radiation dose and amount of contrast medium did not differ between the cohorts. No difference was observed in hemodynamic outcomes regarding transvalvular pressure gradients and at least moderate paravalvular leak. Patients implanted with COT had a shorter length of hospital stay (7.1±6.0 vs. 10.3±6.8 days; p<0.001), possibly due to a lower complication rate regarding new conduction disturbances and pacemaker implantation.

Conclusion

TAVI using the cusp overlap deployment technique is associated with an optimized implantation depth and a low rate of procedural complications. Therefore, a reduction of new pacemaker implantations and shortened length of hospital stay could be achieved.

Funding Acknowledgement

Type of funding sources: None.
Prospective evaluation of commissural alignment of balloon-expandable transcatheter heart valves utilizing pre- and post-procedure computed-tomogrpahy
Authors: Steinmetz Y , Wollak A , Vitkon Barkay I , Wolff R , Orlev A , Harari E , Ben Ami C , Shohat O , Glikson M , Dvir D
Published: October 2021

Background

Previous studies suggested that bioprosthetic valve commissural alignment may improve device performance and clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). However, no cath-lab method for correct commissural alignment of balloon-expandable valves was described to-date. Our aim is to evaluate the impact of a predefined patient specific crimped SAPIEN 3 orientation on its final implant orientation in relation to original valve commissures and overlap with coronary arteries as demonstrated by cardiac computed tomography (CT) in tricuspid aortic valve stenosis patients.

Methods and results

A prospective study of patients undergoing TAVI with SAPIEN 3 (Edwards Lifesciences), including post procedure cardiac CT. Patients were divided to 2 groups, a planned group in which the SAPIEN 3 was crimped before implantation in a pre-defined position, and a control group with conventional valve deployment. All patients underwent pre and post TAVI cardiac CT, which were evaluated by cardiac imaging experts that were blinded to the method of valve deployment. Twenty-eight patients were prospectively evaluated before and after TAVI with SAPIEN 3. All patients had elevated risk for open-heart surgery (age 77.6±7.9 years, 68% male, STS PROM 4.4%±3.4%). Fifteen patients were included in the active alignment group vs. thirteen patients in the control. Patients in the active alignment group had a trend for more correct commissural alignment (73.3% vs. 38.5%, p=0.06). There was no statistically significant difference in patient characteristics, echocardiographic measures or in anatomical CT features between the active commissural alignment and control groups.

Conclusion

This is probably the first study that shows that patient-specific initial crimped orientation of balloon-expandable TAVI may improve our ability to have correct commissural alignment of the implanted valve. Our prospective study continues to recruit patients and updated study results will be presented.

Funding Acknowledgement

Type of funding sources: None.
Machine learning identifies clinical parameters to predict mortality in patients undergoing transcatheter mitral valve repair
Authors: Zweck E , Spieker M , Horn P , Iliadis C , Metze C , Kavsur R , Tiyerili V , Nickenig G , Baldus S , Kelm M , Becher M U , Pfister R , Westenfeld R ,   Heart Failure Network Rhineland
Published: October 2021

Background

Transcatheter Mitral Valve Repair (TMVR) with MitraClip is an important treatment option for patients with severe mitral regurgitation. The lack of appropriate, validated and specific means to risk stratify TMVR patients complicates the evaluation of prognostic benefits of TMVR in clinical trials and practice.

Purpose

We aimed to develop an optimized risk stratification model for TMVR patients using machine learning (ML).

Methods

We included a total of 1009 TMVR patients from three large university hospitals, of which one (n=317) served as an external validation cohort. The primary endpoint was all-cause 1-year mortality, which was known in 95% of patients. Model performance was assessed using receiver operating characteristics. In the derivation cohort, different ML algorithms, including random forest, logistic regression, support vectors machines, k nearest neighbors, multilayer perceptron, and extreme gradient boosting (XGBoost) were tested using 5-fold cross-validation in the derivation cohort. The final model (Transcatheter MITral Valve Repair MortALIty PredicTion SYstem; MITRALITY) was tested in the validation cohort with respect to existing clinical scores.

Results

XGBoost was selected as the final algorithm for the MITRALITY Score, using only six baseline clinical features for prediction (in order of predictive importance): blood urea nitrogen, hemoglobin, N-terminal prohormone of brain natriuretic peptide (NT-proBNP), mean arterial pressure, body mass index, and creatinine. In the external validation cohort, the MITRALITY Score's area under the curve (AUC) was 0.783, outperforming existing scores which yielded AUCs of 0.721 and 0.657 at best. 1-year mortality in the MITRALITY Score quartiles across the total cohort was 0.8%, 1.3%, 10.5%, and 54.6%, respectively. Odds of mortality in MITRALITY Score quartile 4 as compared to quartile 1 were 143.02 [34.75; 588.57]. Survival analyses showed that the differences in outcomes between the MITRALITY Score quartiles remained even over a timeframe of 3 years post intervention (log rank: p<0.005). With each increase by 1% in the MITRALITY score, the respective proportional hazard ratio for 3-year survival was 1.06 [1.05, 1.07] (Cox regression, p<0.05).

Conclusion

The MITRALITY Score is a novel, internally and externally validated ML-based tool for risk stratification of patients prior to TMVR. These findings may potentially allow for more precise design of future clinical trials, may enable novel treatment strategies tailored to populations of specific risk and thereby serve future daily clinical practice.

Funding Acknowledgement

Type of funding sources: None. Summary Figure
Right ventricular diastolic dysfunction and postoperative cardiac complications in patients undergoing coronary artery bypass grafting
Authors: Sumin A , Korok E V , Sergeeva T Y U
Published: October 2021

Background

Perioperative right ventricular (RV) dysfunction is associated with increased postoperative morbidity and mortality in patients undergoing heart surgery and large vessels. Almost all data on the importance of right ventricle function is specifically focused on its systolic dysfunction, which usually develops with severe left heart dysfunction. At the same time, the perioperative assessment of right ventricle filling during cardiac surgery has been far less studied.

Purpose

To evaluate whether the presence of preexisting RV diastolic dysfunction in patients undergoing coronary artery bypass grafting (CABG) is associated independently with higher incidents of postoperative cardiac complications. Design: one-center observational study.

Methods

The patient population consisted of those who underwent CABG in the cardiovascular surgery department from February 2017 to November 2018 (n=200, 153 males). Transthoracic echocardiography was performed on a Philips Clear Vue 550. Following RV systolic and diastolic parameters were studied: peak velocity of early (Et) and late (At) transtricuspid RV filling and their ratio. Tissue Doppler imaging was used to measure peak diastolic and systolic velocities at the tricuspid annulus (et', a't, s't), TAPSE, and RV Tei index. All patients were divided into 2 groups: with RV diastolic dysfunction (RVDD, n=92), and without RV diastolic dysfunction (control, n=108).

Results

Compared with those without RVDD, in patients with RVDD postoperative heart failure (HF, primary outcome) developed more frequently (p=0.026). The risk of developing postoperative HF was 3.39 in patients with RVDD compared with patients without RVDD (95% CI, 1.15–9.97; p=0.025). Left ventricular ejection fraction (LVEF) increase predicted a lower risk of postoperative HF with an OR = 0.95 (95% CI, 0.9–1.0; p=0.051). Female sex, cardiopulmonary bypass, increase of left ventricular mass index, and Et / At ratio also increased the risk of postoperative HF developing. But only RVDD, cardiopulmonary bypass and female sex were associated independently with development postoperative HF in the multivariate analyses.

Conclusion

Decreased preoperative RV diastolic function, cardiopulmonary bypass and female sex are independent risk factors for development postoperative HF after CABG in coronary artery disease patients. In contrast, LVEF and RV systolic dysfunction were not associated independently with this outcome. Therefore, assessment of preoperative RV diastolic function will be useful for predicting development postoperative HF following CABG. In addition, the Et / At ratio was the best echocardiographic marker associated with the postoperative HF development after CABG surgery.

Funding Acknowledgement

Type of funding sources: None.
Impact of tricuspid repair on surgical death in patients undergoing mitral valve surgery due to rheumatic disease
Authors: Viana T , Vieira De Melo R M , Da Silva D N V , Santana G P , De Paula M L N , Azevedo D F C , Figueiredo C S , Lopes J B , Damasceno L M , Soares P F , Santos J V S , Tolentino A , Passos L C S
Published: October 2021

Introduction

Observational studies differ on the impact of performing tricuspid repair on surgical mortality. Some studies demonstrate increased surgical mortality related to right ventricular failure and circulatory shock, while there are other studies that evidence improvement in quality of life and signs of right heart failure in the long time.

Objective

To evaluate the impact on surgical mortality of concomitant tricuspid annuloplasty in patients undergoing cardiac surgery for rheumatic mitral valve disease, who have moderate to severe tricuspid regurgitation.

Methods

This is a prospective cohort from January 1, 2017 to December 30, 2020. All patients over 18 years of age who underwent cardiac surgery to correct rheumatic mitral valve disease with moderate to significant tricuspid regurgitation were included. The primary outcome was 30-days mortality.

Results

165 patients were included, 98 (59.4%) underwent tricuspid valve annuloplasty. The mean age was 46, 5 (±12) years, the median of Euroscore II was 2,33%. The 30-days mortality was 17 (10.3%) and there was no difference between the groups submitted or not to tricuspid repair: 12 (12.2%) versus 5 (7.5%); p=0.44, respectively. In the multivariate analysis involving seven variables with a potential prediction of death in 30 days, tricuspid repair had no association with death, RR 2,4 (0,5 – 8,3); p=0.27.

Conclusion

In patients with rheumatic heart disease undergoing cardiac surgery for rheumatic mitral valve disease, perform tricuspid annuloplasty in individuals who had moderate to severe tricuspid insufficiency was not associated with increased surgical mortality.

Funding Acknowledgement

Type of funding sources: None.
Simultaneously measured interarm blood pressure difference is not associated with pulse wave velocity in a clinical dataset of at-risk hypertensive patients
Authors: Nolde J , Lugo-Gavidia L M , Kannenkeril D , Chan J , Robinson S , Jose A , Joyson A , Schlaich L , Carnagarin R , Azzam O , Kiuchi M , Schlaich M ,   Dobney Hypertension Centre
Published: October 2021

Background/Introduction

Recent analysis of systolic inter-arm differences in blood pressure from the INTERPRESS-IPD Collaboration suggest an association with increased all-cause mortality, cardiovascular mortality and cardiovascular events, previous studies have demonstrated associations with other risk parameters.

Purpose

We aimed to reproduce these associations in a cohort of 199 treated, at-risk, hypertensive patients with pulse wave velocity (PWV) as a surrogate marker of cardiovascular (CV) damage.

Methods

Simultaneously measured Inter-arm blood pressure differences, 24 hour ambulatory BP and PWV were measured in 199 treated patients of a tertiary hospital hypertension outpatient clinic. Associations between systolic inter-arm BP difference and PWV were analyzed with uni- and multivariate regression models.

Results

Out of 199 participants, 90 showed an Inter-arm blood pressure difference of more than 5 mmHg. The Inter-arm difference was not associated with PWV. Furthermore, neither observed single blood pressure measurements nor 24 hour ambulatory blood pressure was associated with Inter-arm blood pressure differences.

Conclusion

In our clinical patient cohort we failed to observe an association between inter-arm BP differences and PWV. Mode of assessment, study design or the sample characteristics of this treated, hypertensive cohort may explain the negative results. The limited sample size of the study poses a challenge to the detection of smaller effects in our study.

Funding Acknowledgement

Type of funding sources: None.
The behavior of systolic blood pressure variability indices in the SPRINT trial. A randomized clinical trial
Authors: Rueda-Ochoa O L , Reyes-Prada M A , Celis Amaya R S ,   Electrocardiography Research Group, Industrial University of Santander
Published: October 2021

Background

We previously report that intensive hypertension treatment increases visit-to-visit variability in the total SPRINT population and in all subgroups under study, based on coefficient of variation (CV) calculated during all follow-up time, previous to SPRINT primary outcome. It becomes important describes the behavior of other long-term SBP variability indices.

Purpose

To evaluate the interaction between intensive treatment and systolic blood pressure variability, measured during the first year of follow-up, by coefficient of variation (CV), standard deviation (SD), variability independent of the mean (VIM), and average true variability (ARV), and its contribution to SPRINT primary outcome.

Methods

We include 9068 SPRINT participants with 128139 repeated SBP measurements. Participants were randomly assigned to intensive (SBP <120 mmHg) vs standard treatment (SBP between 135–139 mmHg). The primary outcome was a composite outcome of myocardial infarction, other acute coronary syndromes, acute decompensated heart failure, stroke, and cardiovascular mortality. The coefficient of variation (CV), standard deviation (SD), variability independent of the mean (VIM), and average true variability (ARV) was calculated taking into account all SBP measurements during the first year of follow-up. Effect of the interaction between intensive treatment and SBP variability indices over the SPRINT primary outcome was calculated in both total population and each SPRINT subgroups.

Results

All SBP variability indices showed association with increase the risk of the SPRINT primary outcome. However, all interaction terms between treatment and SBP variability were not statistically significant. The ARV of intensive treatment group, showed a tendency to increase the risk in all its quartiles and deciles, being significantly associated with the development of the primary outcome for the fourth, eighth and tenth deciles (see table). Regarding the intensive treatment subgroups, the male subpopulation showed a significant risk of primary outcome in the upper decile of all indices and in the upper quartile of them, except CV. As well as in the subpopulation that was not of black race, the risk was evidenced in the decile and upper quartile of all the indices (see table)

Conclusions

ARV is the visit-to-visit blood pressure variability index that presented the most significant increase for the development of the primary outcome after the first year of follow-up in the SPRINT study intensive treatment population. Aiming to corroborate the association between intensive treatment and the adverse cardiovascular events risk, is required the evaluation of the visit-to-visit variability indices in other randomized clinical trials with larger populations which compares standard and intensive treatment.

Funding Acknowledgement

Type of funding sources: None. Hd: higher decile; Hq: higher quartile
The relationship between diastolic blood pressure and the risk of cardiovascular events in patients with atrial fibrillation whose systolic blood pressure was treated to less than 130 mmHg
Authors: Ikeda S , Iguchi M , Ogawa H , Ishigami K , Doi K , Hamatani Y , Ide Y , Fujino A , Ishii M , Masunaga N , Esato M , Wada H , Hasegawa K , Abe M , Akao M
Published: October 2021

Background

Hypertension is one of the major risk factors of cardiovascular events in patients with atrial fibrillation (AF). Low diastolic blood pressure (DBP) has been reported to be associated with the incidence of cardiovascular events, but current guidelines recommend an intensive blood pressure target of less than 130/80 mmHg for AF patients taking oral anticoagulants without mentioning the lower limits of DBP.

Methods

The Fushimi AF Registry is a community-based prospective survey of AF patients in a city of Japan. Follow-up data were available in 4,472 patients, and hypertensive patients who received prescription of any antihypertensive agents and whose systolic blood pressure was treated to less than 130 mmHg were available were examined (n=1,319). We divided the patients into four groups according to their DBP at baseline; G1 (DBP<60 mmHg, n=349), G2 (60≤DBP<70, n=434), G3 (70≤DBP<80, n=386) and G4 (80≤DBP, n=150), and compared the clinical background and outcomes among groups.

Results

The proportion of female was grater in G1 group, and the patients in G1 group were older. During the median follow-up of 2,458 days, in Kaplan-Meier analysis, the incidence rates of cardiovascular events (composite of cardiac death, ischemic stroke, systemic embolism, non-fatal myocardial infarction and heart failure hospitalization during follow up) were the highest in G1 group and the lowest in G3 group (G1: 7.2% per person-year vs. G2: 4.9% vs. G3: 2.2% vs. G4: 4.4%; p<0.01). Multivariate Cox proportional hazards regression analysis revealed that DBP was an independent determinant of cardiovascular events (G1 vs. G3; hazard ratio (HR): 1.96, 95% confidence intervals (CI): 1.39–2.76, G2 vs. G3; HR: 1.79, 95% CI: 1.28–2.50, G4 vs. G3; HR: 1.56, 95% CI: 0.99–2.45) (Figure 1). When we examined the association of DBP according to 10 mmHg increment, patients with excessively low DBP (<50 mmHg) had significantly higher incidence of cardiovascular events than patients with DBP of 70–79 mmHg (HR: 2.80, 95% CI: 1.81–4.33), and DBP exhibited J curve association with higher incidence of cardiovascular events (Figure 2).

Conclusion

In Japanese AF patients whose systolic blood pressure was treated to less than 130 mmHg, patients with excessively low DBP had significantly higher incidence of cardiovascular events, and DBP exhibited J curve association with higher incidence of cardiovascular events.

Funding Acknowledgement

Type of funding sources: None.
Association between short-term pulse pressure variability and cardiovascular death among normotensive adults
Authors: Visaria A D , Kostis J B , Kostis W J
Published: October 2021

Background

Short-term systolic and diastolic blood pressure variability have been associated with adverse cardiovascular (CVD) outcomes, especially in conjunction with traditional CVD risk factors. However, there are limited data on the relationship between short-term pulse pressure (systolic minus diastolic blood pressure) variability (PPV) and mortality.

Purpose

We examined the association between PPV and death due to cardiovascular causes.

Methods

Data from the United States National Health and Nutrition Examination Surveys (NHANES-III, 1988–1994) were linked to death certificates from the National Death Index until December 31, 2015. A total of 6,340 adults (2,981 men and 3,359 non-pregnant women) aged ≥20 years who were normotensive (BP<140/90, without history of hypertension and not taking antihypertensive medication) were followed for an average of 22.3 years. Individuals with any self-reported history of CVD (heart failure, myocardial infarction, stroke) were excluded. PPV was calculated as the standard deviation of six pulse pressure measurements across two visits less than two weeks apart. PPV was categorized into quartiles: Q1: ≤4, Q2: 4.1–6, Q3: 6.1–8, Q4: >8 mmHg. The primary outcome was CVD mortality. Cox proportional hazards models were used to determine hazard ratios, adjusting for demographics & sociobehavioral factors (age, race, ethnicity, poverty-income ratio, smoking status), cardiometabolic factors (waist circumference, HDL, triglycerides, microalbuminuria, diabetes status), BP-related factors (mean pulse pressure, between-visit variability), and accounting for the complex survey design.

Results

Whereas the proportion of CVD death among men was similar across quartiles, women in Q4 had significantly higher proportion of CVD death (Figure 1; p=0.0055). Women in Q4 of PPV had significantly higher risk of CVD mortality (unadjusted HR 3.63, 95% CI 1.66, 7.90) compared to Q1, even after 1) adjustment for demographics & sociobehavioral factors (HR 2.80, CI 1.40, 5.60), 2) additional adjustment for cardiometabolic factors (HR 2.59, CI 1.33, 5.05), and 3) additional adjustment for mean pulse pressure and between visit variability (HR 2.71, CI 1.42, 5.17). Men in Q4 also had increased, but insignificant, risk of CVD mortality (adjusted HR 1.06, CI 0.38, 2.96). Gender significantly modified the effect of PPV on CVD mortality (p=0.036 for interaction term). When looking at the first visit alone, every 1 mmHg increase in PPV was associated with a 11% significant increase in risk of cardiovascular mortality in females (1.11 [1.03, 1.19]), but only a 1% insignificant increase in males (1.01 [0.91, 1.12]).

Conclusions

These NHANES data with an average 22.3 years of follow-up indicate that two visit pulse pressure variability is associated with cardiovascular death and that this effect is more pronounced in women.

Funding Acknowledgement

Type of funding sources: None. Figure 1. Pulse Pressure Variability and Mortality
Geriatric depression and quality of life in atrial fibrillation: the geriatric population analysis
Authors: Senoo K , Yukawa A , Okura T , Iwakoshi H , Nishimura T , Matoba S
Published: October 2021

Background and purpose

Arrhythmias such as atrial fibrillation (AF) is often associated with depression, with vague anxiety about symptom and the risk of serious complication such as stroke or heart failure. In the geriatric population, geriatric depression often occurs with an increase of physical illness and has substantial costly and quality of life implications for functionality and life satisfaction. However, few studies have investigated relationship between geriatric depression and Quality of Life (QoL), and arrhythmia symptoms (palpitation, dyspnea and chest discomfort).

Method

Between November 2019 and October 2020, elderly people (≥65 years) who participated in the AF awareness symposium were enrolled in this study. They were divided into 4 groups according to the presence or absence of chest symptom and AF, and were examined geriatric depression by Geriatric depression scale (GDS)-15 and Quality of Life (QoL) by the 12-item Short- Form Health Survey (SF-12) including physical and mental health status.

Results

Of the 1511 subjects, 1364 were analyzed after excluding 147 with missing values. Among them, 911 were in the non-AF group without symptom (Group A), 43 in the AF group without symptom (group B), 323 in the non-AF group with symptom (group C), and 87 in the AF group with symptom (group D).

Geriatric depression rates (defined as GDS-15 ≥10) were 2.7% in non-symptomatic group (2.7% in A [n=25] and 2.3% in B [n=1]) and 7.8% in symptomatic group (7.4% in C [n=24] and 9.2% in D [n=8]). (P<0.05) In multivariate regression analysis, an increased risk of geriatric depression was observed in groups C and D (group C: odds ratio [OR]=2.54, CI: 1.40, 4.61, P<0.01 and group D: OR=3.13 CI: 1.16, 7.57, P=0.02).

The mean values of physical and mental health status in SF-12 were 48.5 (±7.9) and 56.7 (±6.8) in A, 44.6 (±10.7) and 57.3 (±7.3) in B, 45.0 (±9.9) and 53.8 (±7.7) in C, and 43.4 (±10.8) and 54.8 (±8.6) in D, respectively. Physical health status in SF-12 was associated with group C (C vs A: estimate −2.95 [CI: −4.03, −1.87], p<0.01) and D (D vs A: estimate −2.93 [CI: −4.88, −0.97], p<0.01), other than heart failure, older age and female. Mental health status in SF-12 was associated with group C (C vs A: estimated −2.34 [CI: −3.72, −1.42], p<0.01), heart failure, hypertension, older age, female and group D (D vs A: estimate −1.63 [CI: −3.31, 0.05], p=0.06), but not statistically significant. Individuals with arrhythmia symptom (group C and D) had lower physical and mental health status than those without (group A and B) (P<0.05).

Conclusion

Older adults with arrhythmia symptoms were more likely to have geriatric depression and low QoL, especially those with symptomatic AF, with a geriatric depressive complication rate of 9.2%. Further studies are needed to investigate whether improving physical health status can improve QoL and geriatric depression.

Funding Acknowledgement

Type of funding sources: None.
Residual risk after acute coronary syndrome: the PRATO-ACS Registry
Authors: Toso A , Leoncini M , Maioli M , Villani S , Bellandi F ,   PRATO-ACS
Published: October 2021

Background

Despite administration of current evidence-based therapies, substantial residual risk for cardiovascular events persists, particularly after acute coronary syndrome (ACS). It is well known that different inflammatory, metabolic, renal factors concur in defining the residual risk, beyond lipids, platelets and coagulation.

Purpose

The purpose of this study is to analyze the prevalence of various residual risk factors in patients at 1 month after ACS and their association with all-cause death within 3 years.

Methods

Of the 1585 patients admitted to our center for ACS and included in the PRATO-ACS Registry we selected the 1099 patients (69±12 yrs; 30% female; 26.7% with diabetes; 73% NSTE-ACS and 27% STEMI) who underwent laboratory analyses 1 month after the index event. All patients had undergone early invasive strategy and received high intensity statins during hospitalization and at discharge. The frequency of 5 specific risk factors was evaluated: LDL cholesterol ≥70 mg/dl; high sensitivity C reactive protein (hs-CRP) ≥2 mg/l; triglycerides ≥135 mg/dl; high glycosylated hemoglobin (HbA1c) ≥6.5% in diabetic and ≥5.7% in non-diabetic patients; decrease in estimated glomerular filtration rate (eGFR) ≥25% compared to baseline. Patients were followed up for three years. The association between the individual risk factors and all-cause death within 3 years was evaluated with Cox proportional analysis expressed by hazard ratio (HR) and 95% confidence intervals (CI).

Results

The Table lists the prevalence of the five residual risk factors at 1 month and the mortality HR (95% CI) within 3 years for each risk factor.

Conclusions

After ACS, despite the secondary prevention therapy (high intensity statins), residual risk factors, all measured at 1 month, are persistently elevated in the majority of patients. Their association with all-cause death at 3 years is significantly high for inflammatory and metabolic parameters as well as renal function deterioration. These findings should prod us to develop new strategies that target all residual risk factors, not only lipid profile.

Funding Acknowledgement

Type of funding sources: None.
Remnant cholesterol is an independent determinant of the presence and extent of subclinical carotid atherosclerosis in statin-naive individuals
Authors: Delialis D , Aivalioti E , Mavraganis G , Dimopoulou A M , Sianis A , Angelidakis L , Patras R , Petropoulos I , Ioannou S , Syrigou R , Kanakakis J , Georgiopoulos G , Stellos K , Stamatelopoulos K
Published: October 2021

Background

Despite continuous improvements of diagnostic and therapeutic algorithms for cardiovascular disease (CVD), mortality from CVD remains high suggesting unaddressed residual risk. Remnant cholesterol (RC) consists the cholesterol content of triglyceride-rich lipoproteins, which along with LDL cholesterol infiltrate the arterial wall, accumulate and cause atherosclerosis. Increased remnant cholesterol (RC) levels have been previously associated with future adverse cardiac events despite hypolipidemic therapy. However, a mechanistic association of RC levels with human atherosclerosis in vivo has not been proven in a clinical setting.

Purpose

To evaluate the association of RC levels with the presence and extend of subclinical carotid atherosclerosis.

Methods

In this retrospective cohort study, 438 subjects from the Athens Vascular Registry without clinically overt CVD or treatment with statin were recruited. Atherosclerotic burden was assessed by B-mode carotid ultrasonography using: 1. Maximal carotid wall thickness [maxWT, the highest intima-media thickness (IMT) or highest atherosclerotic plaque thickness (PLQ) if present derived from all carotid sites], 2. Total thickness (sumWT, sum of maximal wall thickness), 3) high plaque burden (PLQ ≥2) and 4) average carotid IMT (avgIMT). RC was calculated using the formula RC=total cholesterol-LDL-C-HDL-C.

Results

Mean (SD) age was 54.8±12.4 years old with 41% being males. Subjects with RC>median (=18mg/dl) had higher sumWT (6.12±0.7 vs 5.57±1.7, p=0.002), maxWT (1.61±0.7 vs 1.43±0.7, p=0.008) and avgIMT (0.88±0.16 vs 0.83±0.16, p=0.003) vs RCmedian was associated with higher odds for increased sumWT (highest tertile, OR: 2.15 95% CI 1.26–3.66, p=0.006) and maxWT (OR: 2.15 95% CI: 1.38–3.33, p=0.001), and a higher plaque burden (≥2 plaques, OR: 2.1 95% CI 1.93–3.1, p<0.001) after adjustment for age, gender and systolic blood pressure, glomerular filtration rate, smoking, diabetes mellitus, body mass index and LDL-C

Conclusion

In a statin-naive population without clinically overt CVD, increased RC levels were associated with the presence and extend of subclinical carotid atherosclerosis. These findings provide novel mechanistic insight into mechanisms associated with increased CVD risk in individuals with high RC levels.

Funding Acknowledgement

Type of funding sources: None.
MicroRNA profile analysis in pericoronary adipose tissue of diabetic patients with significant coronary artery disease
Authors: Marketou M , Plevritaki A , Kontaraki J , Kalogerakos P , Kochiadakis G , Anastasiou I , Paradaki S , Zervakis S , Maragkoudakis S , Parthenakis F , Lazopoulos G
Published: October 2021

Background

Pericoronary adipose tissue (PCAT) regulates arterial homeostasis, is considered to act in paracrine manner,and plays a role in the pathogenesis of atherosclerosis. PCAT may be a source of microRNAs (miRs) that target other tissues and act as messengers for intercellular communication. In this study, we investigated whether the PCAT surrounding coronary occlusive atherosclerotic lesions shows specific miRs expression patterns in patients with diabetes type 2 compared to non-diabetic patients.

Methods

We enrolled 43 patients (29 men, aged 63±12 years old) with 3-vessel coronary artery disease who underwent elective coronary bypass surgery with and without diabetes type 2. The PCAT samples were received from all participants. miR-133a, miR-21, miR-26b, miR-9 and miR-143 expression levels in PCAT cells were quantified by real-time reverse transcription polymerase chain reaction.

Results

Twenty-one patients with diabetic type 2 (14 men, 64±10 years old) and twenty=two non-diabetic patients (15 men, 62±15 years old) were included in the study. PCAT analysis showed a significant upregulation of miR-21 levels in diabetic compared to non-diabetic patients (181±76 versus 21±15, p=0.04). Diabetic patients also revealed a significant increase of miR-26b and miR-143 expression in PCAT samples compared to on-diabetics (33±22 versus 16±13, p=0.02, 93±42 versus 16±23, p=0.01). No significant differences between the two sites were observed in PCAT expression of miR-133a and miR-9 (73±12 versus 130±143, 56±44 versus 34±33, respectively, p =NS for both).

Conclusions

miRs expression in PCAT from diabetic patients with significant coronary disease show a distinct expression profile. Our study opens new perspectives in the pathophysiologic role of PCAT in atherosclerotic complications of diabetes and should be further investigated.

Funding Acknowledgement

Type of funding sources: None.
Association of adipose tissue insulin resistance and serum free fatty acid levels with the incidence of type 2 diabetes: a retrospective cohort study
Authors: Sasaki N , Maeda R , Ozono R , Nakano Y , Higashi Y
Published: October 2021

Background

Insulin resistance in adipose tissue attenuates the suppression of lipolysis, leading to increased free fatty acid (FFA) release. The excess FFA may be involved in the development of type 2 diabetes.

Purpose

In this study, we investigated the association of adipose tissue insulin resistance and serum free fatty acid levels with the incidence of type 2 diabetes.

Methods

This is an observational study involving 6800 participants (3451 women, mean age 69.2 years) without diabetes who underwent 75-g oral glucose tolerance test (OGTT) at baseline. The participants were divided into the obesity and nonobesity groups on the basis of body mass index of ≥25 and <25 kg/m2, respectively. Serum FFA levels were assessed before and 30, 60, and 120 min after glucose ingestion, and the total area under the FFA curve (AUCFFA) was calculated. Adipose tissue insulin resistance was assessed using adipose insulin resistance index (adipo-IR) calculated based on fasting FFA and insulin concentrations. The homeostasis model assessment of insulin resistance (HOMA-IR), and the Matsuda index were evaluated as measures of insulin resistance in the liver and whole-body, respectively. High adipo-IR, high fasting FFA, great AUCFFA high HOMA-IR, and low Matsuda index were determined based on the optimal cutoff values from ROC curve analysis.

Results

Over a mean 5.3-year follow-up period, 485 participants developed type 2 diabetes. Multivariate logistic regression analyses showed that high adipo-IR was a significant predicator for incident type 2 diabetes in the obesity group, but not in nonobesity group. AUCFFA, HOMA-IR, and Matsuda index were significantly associated with incident type 2 diabetes in both the two groups (Table).

Conclusion

Serum FFA levels after glucose loading predict the incidence of type 2 diabetes. Adipose tissue insulin resistance was associated with the risk of type 2 diabetes in individuals with obesity, but not in individuals without obesity.

Funding Acknowledgement

Type of funding sources: None.
Impact of a cardio-oncology rehabilitation program in patients with breast cancer undergoing cardiotoxic treatment
Authors: Oliveira C C , Matos M , Azevedo R , Flores R , Medeiros P , Pires C , Mane F , Silva R , Braga C , Pereira V H
Published: October 2021

Background

Cancer treatment–related cardiotoxicity (CTrCD) is commonly associated with anthracyclines and anti-HER2 agents which are widely used for the treatment of breast cancer. In order to mitgate CTrCD, exercise-based cardio-oncology rehabilitation (COR) involving a structured exercise program has been proposed.

Objectives

To evaluate the impact of a cardiac-rehabilitation program in breast cancer patients submitted to chemotherapy with known cardiotoxicity.

Methods

A systematic review was performed. Two databases were searched, PubMed and SCOPUS. All randomized or controlled trials and other prospective studies published between 2000 and March 2020 which evaluate the impact of an aerobic exercise program on cardiorespiratory fitness (CRF), health-related quality of life (QOL), vascular/endothelial function as well as cardiac assessment namely through the evaluation of left ventricular function and cardiac biomarkers in patients undergoing anthracycline and/or anti-HER2 treatments were included.

Main results

Fourteen studies were included enrolling 578 breast cancer patients with a mean age of 48.80 years. Regarding the impact of exercise in CRF, 5 studies (n=176) reported a significant improvement of VO2 max. and 4 studies of VO2max./kg (n=137). The peak power output was also improved in 4 studies (n=95) in the exercise-group. Considering the assessment of QOL, 3 studies (n=180) revealed significant differences favoring the exercise-group. The results regarding the evaluation of the LVEF were not clear: 2 studies (n=48) reported a significant decrease on LVEF when compared to baseline at the end of the intervention in both groups, despite the exercise program. However, 2 studies (n=97) showed a significant increase on LVEF in the exercise-group. Three studies (n=82) did not found significant differences in global longitudinal strain between groups. Limited evidence was found in vascular and endothelial functon. In 2 studies (n=50), endothelial function measured by brachial artery flow-mediated dilatation significantly improved in the exercise-group. Two studies (n=98) reported no significant impact of exercise on atenuating the increase of cTnI and BNP levels in the course of chemotherapy. On the other hand, when considering NT-proBNP, an increase in its levels was attenuated in the exercise-group.

Conclusions

This study confirms that exercise-based COR seems to be an effective approach to improve several cardiovascular outcomes and quality of life in breast cancer patients.

Funding Acknowledgement

Type of funding sources: None.
Very long-term benefits of cardiac rehabilitation on mortality and cardiovascular events after percutaneous coronary intervention
Authors: Padilla Escamez A , Romero Reyes M J , Otte Alba C , Rufian Andujar S , Molano Casimiro F J
Published: October 2021

Background

Short and medium-term benefits of cardiac rehabilitation (CR) after an acute myocardial infarction (AMI) have been well studied. However, studies on long-term benefits of such programs after percutaneous coronary intervention (PCI) are scarce.

Purpose

The aim of our study was to evaluate the impact of cardiac rehabilitation (CR) on very long-term mortality and morbidity after PCI.

Methods

We conducted a retrospective cohort study of 701 patients who underwent PCI at our hospital between 2004 and 2011. Patients were classified into two cohorts based on whether or not they participated in a CR program phase II. A follow-up was performed in May 2020. We collected the events occurring during a median follow-up of 11 years.

Results

701 patients were included in our study: 291 (41.5%) participated in the CR program, whereas 410 (58.4%) refused to do it. AMI was the most frequent indication for PCI (51.9%), followed by unstable angina (42.8%). The characteristics of the cohort based on participation in the CR program are shown in the table below. Patients who participated in the CR program were younger and mostly male. However, those who refused to do it had a higher cardiovascular risk due to a higher percentage of multivessel disease, diabetes mellitus, kidney failure and history of cerebrovascular accident.

Using multivariate logistic regression, CR participation was found to be associated with significantly reduced all-cause mortality (19.5 vs 48.4%; OR 0.455; IC95% 0.295–0.701; p<0.001) and cardiac mortality (4.5% vs 18.0%; OR 0.361; IC95% 0.181–0.721; p 0.004). CR is also associated with a substantial decrease in heart failure hospitalization (10.0% vs 24.8%; OR 0.557; IC95% 0.331–0.937; p 0.027) and incidence of stroke (5.5% vs 10.6%; OR 0.491; IC95% 0.271–0.890; p<0.017) during the follow-up. No significant differences were observed in re-AMI (20.6% vs 24.1%, p=NS).

Conclusion

CR participation after PCI is associated with lower all-cause mortality, cardiac mortality, heart failure hospitalization rates and morbidity during long-term follow-up.

Funding Acknowledgement

Type of funding sources: None.
Echocardiography and ECG monitoring not very beneficial in COVID-19 follow-up even in long haulers
Authors: Radvan M , Kamenik M , Koc L , Bartecku E , Sykorova L , Kala P ,   COSUBR
Published: October 2021

Objective

To evaluate the need for cardiac evaluation of unselected patients recovered from COVID-19.

Methods

Prospective observational cohort study, which included 105 patients recently recovered from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The diagnosis was established by reverse transcription polymerase chain reaction on swab test of the upper respiratory tract.

Demographic parameters, patient history, clinical evaluation, cardiac blood markers, ambulatory 7-day ECG monitoring and echocardiography have been performed to determine possible cardiac injury.

Results

The study group (n=105) included 58% women, mean age was 46 years (range 18–77 years). Mean time interval between the onset of the infection and the follow-up visit was 107 days. One quarter of the patients required hospitalisation during the acute phase of the disease, the rest recovered at home. 74% suffered from mild form, 3.8% moderate, 18.3% severe and 2.9% of critical form of the disease.

At the time of evaluation 63.5% of the patients were referring the ongoing symptoms, fulfilling the criteria of postcovid syndrome, while more than half of the whole group mentioned at least one symptom of possible cardiac origin (breathing problems, palpitations, exercise intolerance, fatigue).

One patient was diagnosed with paroxysmal atrial fibrillation (woman, 73 years old, dilated left atrium), one patient with atrioventricular block with indication for implantation of the pacemaker (man, 71 years, cardiac MRI didn't found any signs of myocardial inflammation); in one subject (man, 69 years) was diagnosed coronary artery disease due to atherosclerosis with the necessity of revascularization by percutaneous coronary intervention; one woman was prescribed beta-blocker for inadequate sinus tachycardia and palpitations. All these findings are not suspected to be the result of SARS-CoV-2 infection. In three patients mild pericardial effusion was found with no intervention necessary. There was not found any left or right ventricle dysfunction on echocardiography. Only three findings on ECG monitoring mentioned above need a therapeutic intervention.

Conclusion

Despite the significant proportion of the patients with ongoing symptoms beyond the 12 weeks after the onset of the infection SARS-CoV-2, confirmed cardiac impairment is quite rare and distributed mostly among older patients and those with other risk factors.

Funding Acknowledgement

Type of funding sources: Public Institution(s). Main funding source(s): Supported MEYS, RI CZECRIN and by Avast Global Employees Matching Collection.