bluuebunny/crossref_metadata_2025 huggingface dataset:
Effectiveness of atrial fibrillation on high-intensity transient signals to cerebral circulation during TAVI
Authors: Kalantzis C , Vavuranakis M A , Voudris V , Kosmas E , Kalogeras K , Bei E , Katsianos E , Siasos G , Tousoulis D , Tsioufis C , Vavuranakis M
Published: October 2021

Background

Cerebral microemboliazations remain a major concern peri-operatively and following Transcatheter Aortic Valve Implantation (TAVI). We evaluated whether atrial fibrillation may predispose to an increased number of cerebrovascular emboli during the procedure.

Purpose

The aim of the study was to evaluate, using a transcranial doppler, the effect of atrial fibrillation on transient high-intensity signals to middle cerebral arteries during transcatheter aortic valve implantation.

Methods

Consecutive patients who underwent transfemoral TAVI with Evolut™ R bioprosthesis, were categorized into two groups. Group A patients with permanent atrial fibrillation (AF) on anticoagulation, Group B patients with sinus rhythm (SR). Dual antiplatelet therapy with aspirin and clopidogrel was administered to all patients 24 hours prior to the procedure at loading dose, with patients in Group A receiving in addition low-molecular-weight-heparin. The number of detected High Intensity Transient Signals (HITS) was assessed using Rimed Digi-Lite™ Transcranial Doppler on both cerebral arteries during the following phases of the procedure; Phase 0: 30 minutes prior to procedure initiation, Phase I: between access site puncture and introduction of the delivery system, Phase II: during the implantation of the bioprosthesis, until the removal of the delivery system. All implantations were performed without predilation. Furthermore, patients were evaluated by neurologist before TAVI and on discharge day. Safety was evaluated according to VARC-2 criteria.

Results

Twenty-eight patients were evaluated (81±6 years, 16 males (57.1%)). Group A had higher number of total (786±95 vs. 604±103, p=0.002) as well as Phase I HITS (393±94 vs. 285±86, p=0.002). One cerebrovascular event was recorded in Group A and one patient categorized to Group B developed major bleeding due to conversion to femoral surgical cut-down. The average number of received blood units, was higher in AF compared to SR Group (Group 1: 0.8±1.9 vs. Group 2: 0.5±0.7, p: 0.886), without however, reaching statistical significance.

Conclusion

Patients with atrial fibrillation had larger burden of embolic HITS during TAVI indicating high risk patients for embolic cerebrovascular events. This may has implications for future strategies for cerebral embolic protection.

Funding Acknowledgement

Type of funding sources: Public hospital(s). Main funding source(s): Ippokrateio General Hospital of Athens
Prevention of pacemaker lead induced tricuspid regurgitAtion by transesophageal eCho guidEd implantation (PLACE Pilot)
Authors: Gmeiner J , Sadoni S , Orban M , Fichtner S , Estner H , Massberg S , Hagl C , Naebauer M , Hausleiter J , Braun D
Published: October 2021

Background

Lead-induced tricuspid regurgitation (TR) is a frequent complication after pacemaker- and ICD-implantation that is associated with increased mortality and hospitalizations.

Purpose

The aim of this pilot study was to investigate if lead implantation guided by transesophageal echocardiography (TEE) is feasible and might be able to reduce lead-associated TR.

Methods

21 patients with indication for new pacemaker/ICD including a trans-tricuspid lead implantation and TR < grade 2+ were prospectively enrolled and underwent TEE-guided lead implantation in addition to fluoroscopy. Leads were placed according to a dedicated echo protocol with focus on a transgastric en face view of the tricuspid valve targeting a lead position in a tricuspid valve commissure (preferentially postero-septal) and an apical ventricular lead position. (Figure 1) Transthoracic echocardiography (TTE) was performed before implantation and at discharge. 121 consecutive patients with standard lead implantation guided by fluoroscopy only served as a historical control group. TR was assessed by an experienced cardiologist and graded according to current guidelines.

Results

Key baseline characteristics of overall 124 patients with a mean age of 74 years didn't differ between groups. Of note, there was no significant difference regarding device type and baseline TR.

TEE-guided lead implantation was possible in all 21 patients in the TEE-group in deep conscious sedation without occurrence of serious adverse events. Lead placement in a commissure, mostly postero-septal, was possible in 95.2% of patients without worsening of TR (20/21 pts). Based on TEE-guidance, lead position or length was altered in 52.4% of patients (11/21 pts, 6 pts with lead repositioning, 5 pts with modification of lead length).

Compared to baseline, the 21 patients in the TEE-group did not show worsening of TR at discharge. In contrast, TR worsening by one grade occurred in 13.6% of patients (14/103 pts) with new onset of TR ≥2+ in 6.8% of patients (07/103 pts) in the control group (p=0.001).

At discharge, lead position was evaluated using 2D and 3D TTE in a subset of patients. In all examined patients (14/14 pts) lead position was unchanged compared to intraprocedural position and stable during inspiration vs. expiration as well as in upright vs. horizontal position.

Conclusion

TEE-guidance during PM/ICD-implantation was safe and feasible and resulted in steps to optimize lead position in a relevant number of patients. At discharge lead position remained stable and TEE-guided lead implantation was associated with less worsening of TR than standard lead implantation guided by fluoroscopy.

Funding Acknowledgement

Type of funding sources: None. TEE view with targeted lead position
Sinus of Valsalva Dimension and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation
Authors: Tomii D T , Okuno T O , Heg H D , Grani C G , Lanz J L , Praz F P , Storteckey S S , Windecker S W , Pilgrim T P , Reineke D R
Published: October 2021

Background

Progressive dilatation of the aortic root is a common finding in patients with aortic stenosis. Although ascending aortic root anatomy is routinely evaluated on pre-procedural multi-detector computed tomography (MDCT), its clinical significance has not been adequately studied.

Purpose

We aimed to investigate the impact of the sinus of Valsalva (SOV) dimension on clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI).

Methods

In a prospective TAVI registry, we retrospectively assessed SOV dimensions by pre-procedural MDCT. Patients were stratified according to tertiles of SOV diameter index to body surface area (SOVi). The primary endpoint was all-cause mortality at 1 year.

Results

Among 2066 consecutive patients undergoing TAVI between August 2007 and June 2018, 1554 patients were eligible for the present analysis. Patients in the large SOVi group were older (83±6 vs. 82±6 vs. 81±6; p<0.001) and had a higher Society of Thoracic Surgeons Predicted Risk of Mortality (6.3±3.8 vs. 5.1±3.1 vs. 4.9±3.5; p<0.001) than those in the other groups. Patients in the large SOVi group had a higher incidence of moderate or severe paravalvular regurgitation (11.9% vs. 4.5% vs. 3.5%; P<0.001). At 1 year, a large SOVi was independently associated with an increased risk of mortality (HR: 1.64; 95% CI: 1.21–2.23; P=0.001) and major or life-threatening bleeding (HR: 1.30; 95% CI: 1.03–1.65; P=0.029) after TAVI.

Conclusions

Dilatation of the aortic root at the SOV was associated with adverse outcomes after TAVI. The assessment of the aortic root should be integrated into the risk stratification system in AS patients undergoing TAVI.

Funding Acknowledgement

Type of funding sources: None. Figure 1Figure 2
Gender differences in clinical characteristics in wild-type transthyretin amyloidosis cardiomyopathy
Authors: Takashio S , Morioka M , Nishi M , Nakashima N , Yamada T , Hirakawa K , Hanatani S , Usuku H , Yamamoto E , Matsushita K , Kaikita K , Tsujita K
Published: October 2021

Aims

A significant male predominance has been reported in wild-type transthyretin amyloid cardiomyopathy (ATTRwt-CM). In other words, the female ATTRwt-CM may be overlooked and gender differences in ATTRwt-CM remain unclear. This study aims to examine gender differences in clinical characteristics and diagnostic approaches in ATTRwt-CM.

Methods and results

We retrospectively evaluated 171 consecutive ATTRwt-CM patients diagnosed at our university hospital between December 2002 and December 2020. Twenty-two patients (12%) were women. Women were significantly older at diagnosis (77.3 years vs. 83.3 years; P<0.001) and had a higher advanced New York Health Association functional class (2.23±0.70 vs. 2.57±0.81; P=0.04) than men. In echocardiography, mean interventricular septum diameter was less thick (15.8 mm vs. 14.5 mm; P=0.03) and ejection fraction was preserved (51.7% vs. 57.7%; P=0.08) in women. The mean heart-to-contralateral ratio obtained using 99mTc-labeled pyrophosphate (99mTc-PYP) was significantly lower in women than in men (1.89 vs. 1.64; P=0.001). There was no significant gender difference in high-sensitivity median cardiac troponin T levels at diagnosis (0.055 ng/mL vs. 0.069 ng/mL; P=0.30) or history of carpal tunnel syndrome (57% vs. 55%; P=0.93) and electrocardiograms findings. However, the median B-type natriuretic peptide level was significantly higher (254 pg/mL vs. 434 pg/mL; P=0.02) in women. Moderate to severe aortic stenosis was more frequently observed in women (5% vs. 50%; P<0.001). Histological (78% vs. 59%; P=0.07) and genetic confirmation (78% vs. 59%; P=0.003) of ATTRwt-CM were not performed in women.

Conclusion

Women with ATTRwt-CM were predominantly octogenarians, less hypertrophic, and had weaker cardiac uptake of the 99mTc-PYP tracer than men with ATTRwt-CM. These characteristics contribute to the underdiagnosis of ATTRwt-CM in women. The diagnosis of ATTRwt-CM in women is challenging. Therefore, we must be familiar with the clinical characteristics of women with ATTRwt-CM.

Funding Acknowledgement

Type of funding sources: None.
Patients with mild congenital heart defects and atrial arrhythmias: anticoagulate all or follow the CHA2DS2-VASc score?
Authors: Heidendael J F , Van Engele L J , Bouma B J , Mulder B J M ,   Non vitamin K antagonist Oral anticoagulants for ThromboEmbolic prevention in adult congenital heart disease (NOTE) investigators
Published: October 2021

Purpose

Clinical practice used to anticoagulated all patients with mild congenital heart defects (CHD) and atrial arrhythmias (AA) because of the presence of structural abnormalities. Current guidelines on adult congenital heart disease indicate that in these patients, as per general, the CHA2DS2-VASc score should be followed when deciding upon thromboprophylaxis in case AA. To validate this recommendation, we aimed to assess the incidence of thromboembolism in patients with mild CHD according to CHA2DS2-VASc score using non-vitamin K oral anticoagulants (NOACs) for AA.

Methods

Data are retrieved from the multinational NOTE-registry, which follows ACHD patients on NOACs for several indications since 2014. Patients in whom NOAC was prescribed for atrial arrhythmias were included in this study. The primary endpoint was the incidence of thromboembolism (TE) and major bleeding (MB). Secondary outcomes were minor bleeding and mortality. Risk stratification was performed using CHA2DS2-VASc score at baseline.

Results

The NOTE registry has up to date engaged leading ACHD-centers of up to 14 different countries throughout the world, thereby demonstrating a significant effort to fill the gap in science regarding the efficacy and safety of NOACs in the ACHD population. Out of a total of 638 patients, 72 patients had mild congenital defects and NOACs prescribed for AA. The mean age at baseline was 57 (±12) years and 56% was female. Patients were followed up to a maximum of 7 years (202 patient-years; median 2.5, IQR 1.2–4.0). In all patients with a CHA2DS2-VASc score of 0 (n=24), no TE occurred (annualized TE-rate 0%), while 2 patients suffered a MB (annualized MB-rate 3.3%; Figure 1). In patients with a CHA2DS2-VASc score of 1 (n=8) or ≥2 (n=40) the annualized eventrates were 0% and 0.8% for TE, and 0% and 1.7% for MB, respectively.

Conclusion

These reassuring results demonstrated that the annualized eventrate for TE in patients with mild CHD and a CHA2DS2-VASc score of 0 under treatment with NOACs is very low, at the cost of major bleedings. Following the guidelines seems justified: similar to patients with acquired heart disease the prescription of oral anticoagulant therapy can be refrained from in patients with CHA2DS2-VASc score of 0 and in those with CHA2DS2-VASc score 1 it can be debated weighing the risks and benefits.

Funding Acknowledgement

Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Netherlands Heart Institute Figure 1. Eventrates of TE and MB
Constipation is associated with worse prognosis of thrombolytic AIS: a single-center prospective study
Authors: Zhang B , Yu D , Lu Z
Published: October 2021

Background and purpose

Previous clinical studies have found that constipation was associated with the prognosis of ischemic stroke patients. This information may provide new ideas for thrombolytic AIS (acute cerebral arterial thrombosis) patients' short-term prognostic assessment. Our study was designed to investigate the risk factors of constipation and its association with the prognosis in thrombolytic AIS patients.

Methods

The prospective cohort study included 97 AIS patients treated with intravenous thrombolysis. Three days without defecation in thrombolytic patients was recorded as constipation in clinic. The risk factors for constipation included demographics, clinical characteristics, laboratory parameters and partial treatments. Scores of NIHSS and mRS and length of stay (LOS) in ICU and hospital were used to evaluate the effect of constipation on patients' neurological function and short-term prognosis.

Results

The incidence of constipation was 49.48% in the first three days after intravenous thrombolysis. The use of stomach tube and antibiotics made patients more prone to constipation (odds ratio OR: 5.01, 95% CI: 2.04–12.32, P=0.000; odds ratio: 6.06, 95% CI: 2.35–15.61, P=0.000). The occurrence of constipation resulted in significantly longer ICU and hospital LOS (2.29±1.63 versus 4.75±4.22, P=0.000; 11.08±10.01 versus 15.73±12.36, P=0.044). Moreover, constipation worsened the thrombolytic AIS patients' short-term neurological recovery (mRS at 3 months: 1.53±1.72 versus 2.41±1.92, P=0.02). Oral probiotics for constipation during hospitalization not only prolonged patients' stay in the ICU (2.91±2.28 versus 6.44±4.88, P=0.003), but also resulted in poorer short-term neurological functional outcomes (mRS at 3 months: 1.57±1.53 versus 3.26±1.91, P=0.002).

Conclusions

The occurrence of constipation in the first three days was associated with the longer ICU and hospital stay and a worse short-term prognosis, suggesting that constipation may be a predictor of thrombolytic AIS patients' prognosis. Further studies of constipation and its appropriate therapy strategy are needed to solve the plight of thrombolytic AIS with constipation.

Funding Acknowledgement

Type of funding sources: None.
Direct comparison of bioabsorbable and biodurable polymer everolimus-eluting stent in neointimal stent coverage and in-stent thrombus using high-resolution angioscope
Authors: Nojima Y , Mano T , Nishino M , Fuji K , Nakamura S , Tada H , Mizote I , Ashikaga T , Otsuji S , Takahashi A , Yonetsu T , Takahara M , Okayama K , Nanto S ,   ENCLOSE Clinical Study members
Published: October 2021

Background/Introduction

Although second-generation drug eluting stent (DES) employing biodurable polymer drastically shortened the duration of dual antiplatelet therapy (DAPT), previous reports raised concerns that switching from DAPT to single antiplatelet therapy increased rates of subsequent stent thrombosis with time. Third-generation DES employing bioabsorbable polymer has been introduced so as not to hinder the healing process of the vessel wall, however, at present, both DES with bioabsorbable polymer and those with biodurable polymer are used in parallel. It means there is no conclusive evidence regarding pros and cons of these two types of polymers.

Purpose

This study aims to clarify how bioabsorbable polymer and biodurable polymer act on the human coronary artery by observing neointimal stent coverage (NIC) and in-stent thrombus by comparing the third-generation DES with bioabsorbable-polymer cobalt-platinum everolimus-eluting stent (BP CoPt-EES), and the second-generation DES with biodurable-polymer cobalt-chromium everolimus-eluting stent (DP CoCr-EES).

Methods

This is a multicenter observational study including 11 hospitals. We investigated 70 stents (BP CoPt-EES: 40, DP CoCr-EES: 30) of 60 cases, who underwent stent implantation followed by simultaneous observation by coronary angiography, IVUS and angioscopy within 6 to 12 months. For angioscopy, we used a recently available, high-resolution angioscope with a pixel count of 9,000 which realized both stent coverage analysis and planar thrombus detection precisely. Neointimal stent coverage was graded from G0: non coverage to G3: full coverage, and heterogeneity value of neointima was measured as the difference between maximum and minimum NIC grade.

Results

A strong relationship was observed between NIC grade and in-stent thrombus in all stents (p=0.0011), and between the heterogeneity value and stent thrombus (p=0.012). There was no statistical difference in NIC grade between BP CoPt-EES vs. DP CoCr-EES; grade 0: 0 (0.0%) vs. 2 (6.7%), grade 1: 13 (32.5%) vs. 11 (36.7%), grade 2: 6 (15.0%) vs. 6 (20.0%), grade 3: 21 (52.5%) vs. 11 (36.7%), p=0.17) and neither in the heterogeneity value of neointima (p=0.49). The ratio of stent thrombus did not reach statistical difference; 16 (40.0%) in BP CoPt-EES vs. 17 (56.7%) in DP CoCr-EES (p=0.23).

Conclusion

The existence of stent thrombus was associated with the neointimal stent coverage. There was no significant difference both in neointimal stent coverage and stent thrombus between bioabsorbable polymer cobalt-platinum EES and biodurable polymer cobalt-chromium EES after 6 to 12 months following stent deployment.

Funding Acknowledgement

Type of funding sources: Private company. Main funding source(s): Boston Scientific JapanOvalis ltd
Impact of diabetes on outcome with drug-coated balloons versus drug-eluting stents: the BASKET-SMALL 2 trial
Authors: Wohrle J , Scheller B , Seeger J , Farah A , Ohlow A , Mangen N , Moebius-Winkler S , Weilenmann D , Stachel G , Leibundgut G , Rickenbacher P , Cattaneo M , Gilgen N , Kaiser C , Jeger R V ,   BASKET-SMALL 2
Published: October 2021

Objectives

To evaluate the impact of diabetes mellitus on 3 year clinical outcome in patients undergoing drug-coated balloon (DCB) or drug-eluting stent (DES) treatment for de-novo lesions.

Background

For the treatment of de-novo coronary small vessel disease DCB are non-inferior to DES regarding clinical outcome up to 3 years.

Methods

In this prespecified analysis of a multicenter, randomized, non-inferiority trial, including 758 patients with de-novo lesions in coronary vessels <3mm who were randomized 1:1 to DCB (n=382) or DES (n=376) and followed over 3 years for major adverse cardiac events (MACE: cardiac death, non-fatal myocardial infarction [MI], and target-vessel revascularization [TVR]), outcome was analyzed regarding the presence or absence of diabetes mellitus.

Results

In non-diabetic patients (n=506) rates of MACE (13.0% vs. 11.5%, hazard ratio [HR] 1.24, 95% confidence interval [CI] 0.73–2.09, p=0.43), cardiac death (2.8% vs. 2.9%, HR 0.97, 95% CI 0.32–2.92, p=0.96), non-fatal MI (5.1% vs. 4.8%, HR 1.00, 95% CI 0.44–2.28, p=0.99), and TVR (8.8% vs. 6.1%, HR 1.64, 95% CI 0.83–3.25, p=0.16) were similar in DCB and DES. In diabetic patients (n=252) rates of MACE (19.3% vs. 22.2%, HR 0.82, 95% CI 0.45–1.48, p=0.51), cardiac death (8.8% vs. 5.9%, HR 2.01, 95% CI 0.76–5.31, p=0.16), non-fatal MI (7.1% vs. 9.8%, HR 0.55, 95% CI 0.21–1.49, p=0.24) were similar in DCB and DES, whereas TVR was significantly lower with DCB compared to DES (9.1% vs. 15.0%, HR 0.40, 95% CI 0.17–0.94, p=0.036). In addition, need for TVR was highest in diabetic patients treated with DES (Picture 1).

Conclusions

The rates of MACE are similar in DCB and DES in de-novo coronary lesions of diabetic and non-diabetic patients. In diabetic patients the need for TVR was significantly lower with DCB compared to DES.

Funding Acknowledgement

Type of funding sources: Foundation. Main funding source(s): Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Basel Cardiovascular Research Foundation, and B Braun Medical AG. Picture 1
Clinical outcomes with drug-eluting stents, bare-metal stents, and bioresorbable scaffolds implanted in patients with AMI treated with primary PCI. Data from the Prague-18 trial
Authors: Hlinomaz O , Sabbah M , Knot J , Miklik R , Hromadka M , Varvarovsky I , Dusek J , Jarkovsky J , Tousek F , Majtan B , Simek S , Branny M , Svoboda M , Widimsky P , Motovska Z ,   PRAGUE-18 study group
Published: October 2021

Background

Drug-eluting stents (DESs) are the recommended choice of stents for primary PCI.

Purpose/Methods

The study aimed to determine why interventional cardiologists used non-DESs and how they had influenced the patient prognosis. The efficacy and safety outcomes of the different stents were also compared in treated with either prasugrel or ticagrelor.

Results

Of the PRAGUE 18 study patients, 749 (67.4%) were treated with DESs, 296 (26.6%) with BMS, and 66 (5.9%) with BVS. Cardiogenic shock at presentation and the left main disease, especially as culprit lesion, and right coronary artery stenosis were the reasons for BMS selection.

The incidence of the primary net-clinical EP (CV death, nonfatal MI, stroke, major bleeding, or revascularization) at 7 days was 2.6% vs. 6.5%, and 3.0% in the DESs, BMSs, and BVSs, respectively (HR 2.7; 95% CI 1.419–5.15, P=0.002 for BMS vs. DES and 1.25 (0.29–5.39) for BVS vs. DES, P=0.76). Patients with BMSs were at higher risk of death at 30 days (HR 2.20; 95% CI 1.01–4.76; for BMS vs. DES, P=0.045), and at one year (HR 2.1; 95% CI 1.19–3.69; P=0.01); they also had higher composite of cardiac death, re-MI and stroke (HR 1.66; 95% CI 1.0–2.74; P=0.047) at one year. BMSs were associated with significantly higher rate of primary EPs either treated with prasugrel or ticagrelor.

Conclusion

Patients with the highest risk profile were preferably treated with BMS the contrary to BVS. BMSs were associated with a significantly higher rate of cardiovascular events either treated with prasugrel or ticagrelor.

Funding Acknowledgement

Type of funding sources: Public Institution(s). Main funding source(s): Charles University Cardiovascular Research Program P-35 and Q-38, Charles University, Czech Republic
Novel pressure-regulated deployment strategy for improving the safety and efficacy of balloon-expandable transcatheter aortic valves
Authors: Snir A , Wilson M K , Ju A L , Wong S , Khor L , Naoum C , Wong K , Keech A , Celermajer D S , Ng M K
Published: October 2021

Background

The optimal method for balloon-expandable transcatheter heart valve (THV) deployment remains unknown. Current implantation protocols are volume-dependent and rely on ad-hoc filling of the deployment apparatus without accounting for annular wall tension during prosthesis expansion, predisposing patients to inconsistent clinical outcomes. During THV deployment, the annular wall tension exerted by the expanding prosthesis is determined by prosthesis diameter and balloon pressure (Laplace's Law).

Objective

We proposed and tested a novel method for balloon-expandable THV deployment, aimed at controlling balloon pressure and the resulting annular wall tension to allow optimal prosthesis-annulus apposition while preventing significant tissue injury.

Methods

330 consecutive patients with severe native aortic stenosis who underwent balloon-expandable THV implantation between 2015–2020 were included. 106 patients were considered high-risk for annular rupture. THVs were deployed until reaching a pre-determined balloon pressure; 4–4.5atm in earlier cases to establish experience and safety, later increasing to 5–6.5atm in most cases. Post-dilatation was performed to reduce >mild angiographic regurgitation (PVR). Using a biomechanical model, annular wall stress (tension) was estimated for each case and assessed against recorded rates of post-dilatation, ≥mild paravalvular regurgitation (PVR) on TTE, new PPM or LBBB and annular rupture.

Results

Patients with wall stress >3MPa (n=184) had reduced post-dilatation rate (p<0.001) and final PVR (≥mild, p=0.014). Annular rupture occurred in 2/3 high-risk cases with wall stress >3.5MPa; no rupture occurred in 102 high-risk cases with wall stress ≤3.5MPa. Based on these results, we defined target deployment wall stress levels (3–3.5MPa) and associated deployment pressure per THV size. Patients within this target range (n=136) had 8.1% new PPM, 12.5% new LBBB, 12.7% mild PVR with no cases of ≥moderate PVR. Importantly, there was an inconsistent relationship between deployment balloon volume and resulting annular wall stress.

Conclusion

Pressure-regulated THV deployment is a simple, easily reproducible, safe and effective method, regardless of high-risk anatomical complexities.

Funding Acknowledgement

Type of funding sources: None. Annular wall stress and PVRModel, stress vs volume and new strategy
Prevalence of atherosclerosis risk factors in Egyptian patients with acute coronary syndromes; final data of the nationwide cross-sectional CardioRisk project
Authors: Reda A , Bendary A , Elbahry A , Farag E , Mostafa T , Khamis H , Wadie M , Bendary M , Abdoul Azeem B , Salah R ,   CardioRisk investigators
Published: October 2021

Background

Little are known about the prevalence of atherosclerosis risk factors in Egyptian patients with acute coronary syndromes (ACS). Objective: To describe the prevalence of these risk factors with focus on gender-specific data and patients with premature presentation.

Methods

From November 2015 to August 2018, data were collected from 3224 patients with ACS in 30 coronary care centers covering 11 governorates across Egypt, with focus premature ACS.

Results

The vast majority were males (74%) and the most prevalent age group was (56–65 years) representing 37% of whole study population. Among female patients, 92% were post-menopausal. The prevalence of premature ACS was 51%. Forty five percent of total males and 69.6% of total females with ACS had premature presentation (P<0.001). Abdominal obesity was the most prevalent risk factor (66%). Nearly half of the entire study patients were current smokers (48%). We showed a high prevalence of documented dyslipidemia (48%) as well. Early invasive management strategy was employed in 65% of patients with no significant gender disparity noticed. Vascular access for coronary angiography was most commonly femoral (80% of time). Emergent percutaneous coronary intervention (PCI) was attempted in 53% of patients. Thrombolytic therapy (using Streptokinase) was used in 24% of included participants.

Conclusion

Among Egyptian patients with ACS, premature presentation is common with greater male preponderance. Abdominal obesity is the most prevalent risk factor followed by hypertension. Most traditional risk factors (apart from smoking) were more prevalent in women than men.

Funding Acknowledgement

Type of funding sources: Private company. Main funding source(s): AstraZeneca Table 1. Premature Atherosclerosis subgroupTable 2. Geographic distribution of risk factors
Lifestyle modification based on cluster cardiovascular risk assessment reduced the risk of sleep apnea
Authors: Guo Y , Zhang H , Lip G Y H ,   mAFA investigators
Published: October 2021

Background

Sleep apnea is associated with cardiovascular events, nonetheless, the early concern for multi-risk factor management, complied with guideline-based clinical care pathways, is limit.

Objective

The present study aimed to investigate the impact on the burden of sleep apnea with lifestyle and physical activity modification based on cardiovascular cluster risk factors assessment, supported by a mobile health and wearable devices technologies.

Methods

The adult subjects aged over 18 years were enrolled in China between March 2, 2020 and August 4, 2020, who used a smart phone application “IamHealthy”, to assess the CV risk profile, including weight/activity, diet (the quality of diet was assessed using Alternative Healthy Eating Index,AHEI-2010), psychological status, sleep apnea, cardiac rhythm, blood pressure, blood lipid, diabetes. Once the subjects had compatible smart devices (Huawei Technologies Co., Ltd., Shenzhen, China), they achieved photoplethysmography (PPG)-based sleep apnea monitoring. The healthy lifestyle score (five aspects: diet, smoking, physical activity, alcohol consumption, and Body Mass Index) were calculated and a 3-month personalized App-based lifestyle and physical activity package was proposed for those with sleep apnea. The change on risk of sleep apnea monitored were evaluated.

Results

There were 775 subjects (mean age 48 years old, standard deviation, SD, 14, 90.1% male) with the “IamHealthy” App and 487 subjects (mean age 46 years old, standard deviation, SD, 13, 94.4% male) for sleep apnea monitoring with smart devices. Among these subjects, there were 42.3% subjects with overweight, 13.2% with obese; 44.3% with poor quality of healthy diet (AHEI scores <66), 40.0% with inactive physical activity of <1 time/week. The reported depression (Patient Health Questionnaire, PHQ-9 ≥5) and the anxiety (Generalised Anxiety Disorder, GAD-7 scale ≥5) were 41.2% and 62.5%, respectively. Only 22.4% subjects remained healthy lifestyle with over three low risk lifestyle scores.

Dietary Approaches to Control weight (61.6%), to Stop Hypertension (24%), and Mediterranean dietary (5%); Physical activities to control the weight (84.2%), control blood pressure (8.5%), and CV prevention (6.8%) were commonly proposed.

For subjects using IamHealthy to monitor sleep apnea after matching PPG -smart devices on baseline, the proportion of high-risk of sleep apnea decreased over time (baseline, 1 mon, 3 mons, and 6 mons, 60.67%, 47.25%, 44.12%, and 34.19%, p<0.001, Figure).

Conclusions

Lifestyle modification based on cluster cardiovascular risk assessment reduced the high-risk sleep apnea.

Funding Acknowledgement

Type of funding sources: None.
Discriminatory accuracy of the SOFA score for determining clinical decompensation in patients presenting with COVID-19
Authors: Krepostman N , Collins M , Merchant K , De Sirkar S , Chan L , Allen S , Newman J , Patel D , Fareed J , Berg S , Darki A
Published: October 2021

Introduction

While the global dissemination of vaccines targeting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in a decline in the incidence of infections, the case fatality rates have remained relative stable. A major objective of managing hospitalized patients with documented or suspected COVID-19 infection is the rapid identification of features associated with severe illness using readily available laboratory tests and clinical tools. The sequential organ failure assessment (SOFA) score is a validated tool to facilitate the identification of patients at risk of dying from sepsis.

Purpose

The aim of this study was to assess the discriminatory accuracy of the SOFA score in predicting clinical decompensation in patients hospitalized with COVID-19 infection.

Methods

We conducted a retrospective analysis at a three-hospital health system, comprised of one tertiary and two community hospitals, located in the Chicago metropolitan area. All patients had positive SARS-CoV-2 testing and were hospitalized for COVID-19 infection. The primary outcome was clinical decompensation, defined as the composite endpoint of death, ICU admission, or need for intubation. We utilized the most abnormal laboratory values observed during the admission to calculate the SOFA score. Receiver Operating Curves (ROC) were then constructed to determine the sensitivity and specificity of SOFA scores.

Results

Between March 1st and May 31st 2020, 1029 patients were included in our analysis with 367 patients meeting the study endpoint. The median SOFA score was 2.0 IQR (Q1, Q3 1,4) for the entire cohort. Patients who had in-hospital mortality had a median SOFA score of 4.0 (Q1,Q3 3,7). In patients that met the primary composite endpoint, the median SOFA score was 3.0, IQR (Q1, Q3 2,6). The ROC was 0.776 (95% CI 0.746–0.806, p<0.01).

Conclusion

The SOFA score demonstrates strong discriminatory accuracy for prediction of clinical decompensation in patients presenting with COVID-19 at our urban hospital system.

Funding Acknowledgement

Type of funding sources: Public hospital(s). Main funding source(s): Loyola University Medical Center
LDLc reduction with fixed-dose combination rosuvastatin-ezetimibe in patients with coronary heart disease that are not candidates for PCSK9 inhibitors treatment
Authors: Cordero A , Escribano D , Bertomeu-Gonzalez V , Lopez-Ayala J M , Monteagudo M , Quintanilla A M , Moreno-Arribas J , Perez-Berbell P , Zuazola P
Published: October 2021

Background

Statin plus ezetimibe combination has a recommendation class IIa, level of evidence B, for low-density lipoprotein cholesterol (LDLc) reduction. Since LDLc treatment target for patients with coronary heart disease (CHD) has been recently reduced to <55 mg/dl most patients might need lipid-lowering drugs combinations and fixed-dose combinations are known to increase adherence. Current indications for PCSK9 inhibitors accepted for reimbursement in Spain in patients with CHD are LDL >100 mg/dl despite maximal dose tolerated of statins or any of previous patients with statin intolerance and LDL >100 mg/dl.

Methods

Investigator-initiated retrospective analysis of patients with coronary heart disease that received fixed-dose combination with rosuvastatin-ezetimibe between 2019 and 2020 in a specialized unit for patients with CHD. Inclusion criteria were: CHD and LDLc <100 mg/dl despite statin treatment or >100 mg/dl without previous lipid-lowering treatments. We also analysed patients in whom treatment was initiated at discharge from and acute coronary syndrome (ACS) or with chronic coronary syndrome (CCS)

Results

We analyzed 137 patients, 79.4% males, mean age 62. (12.3) and 24.1% with ACS. Statin treatment before initiation fixed-dose combination was higher in patients with CCS (71.2% vs. 8.2%; p<0.01). Mean LDLc before treatment was 103.0 (30.5) mg/dl and it was higher in patients with ACS (121.3 (40.2) vs. 97.4 (24.4); p<0.001). Median time to second blood test was 203 days (IQR 122–300); mean post-treatment LDLc was 60.8 (21.2) mg/dl and no difference (p=0.18) was found in patients with ACS vs CCS: 56.0 (26.1) vs. 62.4 (19.2) mg/dl. Mean LDLc reduction was 38.5% and it was higher in was higher in ACS patients (49.9% vs. 34.7%) (figure). LDLc <55 mg/dl was achieved in 42.1% of the patients, more frequently in patients with ACS: 59.3% vs. 36.3% (p=0.036). No increase in transaminases was detected and a reduction in triglycerides was found (149.1 (100.4) to 124.7 (82.3) mg/dl; p=0.041).

Conclusions

Treatment with a fixed-dose combination with rosuvastatin-ezetimibe in patients with CHD not candidate for PCSK9 inhibitors is effective and safe for LDLc reduction especially in patients discharged after an ACS.

Funding Acknowledgement

Type of funding sources: None.
Association of statin use in older people primary prevention group with risk of cardiovascular events and mortality: a systematic review and meta-analysis of observational studies
Authors: Awad K , Mohammed M , Zaki M M , Abushouk A I , Lip G Y H , Blaha M J , Lavie C J , Toth P P , Jukema J W , Sattar N , Banach M ,   International Lipid Expert Panel (ILEP)
Published: October 2021

Background

Current evidence from randomized controlled trials on statins for primary prevention of cardiovascular disease (CVD) in older people, especially those aged >75 years, is still lacking.

Purpose

We conducted a systematic review and meta-analysis of observational studies to extend the current evidence about association of statin use in older people primary prevention group with risk of CVD and mortality.

Methods

PubMed, Scopus, and Embase were searched from inception until March 18, 2021. We included observational studies (cohort or nested case-control) that compared statin use vs non-use for primary prevention of CVD in older people aged ≥65 years; provided that each of them reported the risk estimate on at least one of the following primary outcomes: all cause-mortality, CVD death, myocardial infarction (MI), and stroke. Risk estimates of each relevant outcome were pooled as a hazard ratio (HR) with a 95% confidence interval (CI) using the random-effects meta-analysis model.

Results

Ten observational studies (9 cohort and one case-control study; n=872,845) fulfilled our criteria. The overall combined estimate suggested that statin therapy was associated with a significantly lower risk of all-cause mortality (HR: 0.86 [95% CI: 0.79 to 0.93]), CVD death (HR: 0.80 [95% CI: 0.78 to 0.81]), and stroke (HR: 0.85 [95% CI: 0.76 to 0.94]) and a non-significant association with risk of MI (HR: 0.74 [95% CI: 0.53 to 1.02]). The beneficial association of statins with the risk of all-cause mortality remained significant even at higher ages (>75 years old; HR: 0.88 [95% CI: 0.81 to 0.96]) and in both men (HR: 0.75 [95% CI: 0.74 to 0.76]) and women (HR: 0.85 [95% CI: 0.72 to 0.99]). However, this association with the risk of all-cause mortality remained significant only in those with DM (HR: 0.82 [95% CI: 0.68 to 0.98]) but not in those without DM.

Conclusions

Statin therapy in older people (aged ≥65 years) without CVD was associated with a 14%, 20% and 15% lower risk of all-cause mortality, CVD death and stroke, respectively. The beneficial association with the risk of all-cause mortality remained significant even at higher ages (>75 years old), in both men and women, and in individuals with DM, but not in those without DM. These observational findings support the need for trials to test benefits of statins in those above 75 years of age.

Funding Acknowledgement

Type of funding sources: None. Figure 1. Results of the meta-analysis
Inflammasome activation in epicardial, pericardial and subcutaneous adipose tissue in patients with coronary heart disease
Authors: Aakra S A A , Solheim S S , Tonnessen T T , Braathen B B , Hansen C H H , Arnesen H A , Seljeflot I S ,   Center for Clinical Heart research
Published: October 2021

Background

The adipose tissue (AT) compartments surrounding the heart have been claimed to exert different pro-inflammatory properties with different associations with cardiovascular disease states. The epicardial AT (EAT), located close to the coronary arteries between the myocardium and the pericardial layer, seems to be associated with atherosclerosis and metabolic syndrome, whereas the pericardial AT (PAT), separated from the heart by the pericardium, is discussed to have less pro-inflammatory properties.

Purpose

The aim of the present study was to explore any differences in genetic regulation of pro-inflammatory markers included in the inflammasome related pathway in EAT, PAT and in subcutaneous AT (SAT). In addition, any relationship to the corresponding inflammatory markers in the circulation was explored.

Materials and methods

Biopsies from EAT, PAT and SAT, and arterial blood samples were collected from 52 patients with coronary heart disease (CHD) undergoing coronary by-pass surgery (aged 48–82 years, 70% male, median body mass index (BMI) 27.3 kg/m2). RNA was extracted by use of RNeasy Lipid Tissue Mini Kits. Gene expression of Interleukin (IL)-1β, IL-18, NLRP3, Caspase-1, toll-like receptor 4 (TLR4), IL-6, IL-6 receptor and gp130 in the different adipose tissue compartments were analyzed using RT-PCR. Circulating levels where possible, were measured in serum with ELISAs.

Results

We demonstrated that IL-18 and IL-6 were about 4-fold higher expressed in EAT compared to PAT (p<0.01, both) and SAT (p<0.001, both), whereas Caspase-1, IL-6R and gp130 were higher expressed in SAT compared to the other compartments (all p 0.06 - <0.001). TLR4 was significantly higher expressed in PAT compared to EAT (p=0.01) and SAT (p<0.001). No differences in the expression of IL-1β and NLRP3 were found. We could further demonstrate significant correlations between SAT and PAT expression of all the measured genes (r=0.358–0.579, all p≤0.01), except TLR4. No significant correlations between circulating levels and the genetic expression in either AT compartments were observed, and also limited correlations to BMI.

Conclusions

The results shows that only IL-18 and IL-6 were higher expressed in EAT, compared to the two other AT compartments in our non-obese CHD population. The results further show that the inflammasome related genes in pericardial AT associated strongly with subcutaneous AT, suggesting SAT to be more pro-inflammatory than previously expected.

Funding Acknowledgement

Type of funding sources: None.
Obesity and COVID-19 in the octogenarians
Authors: Scarpone M , Bergami M , Cenko M , Bugiardini R , Manfrini O
Published: October 2021

Background

Obesity has been identified as the comorbidity more frequently associated with severe forms of COVID19. As the very elderly subjects are particularly prone to severe forms of the disease, but are less affected by obesity we specifically addressed the question on the influence of age on the relationship between BMI and COVID19 prognosis.

Purpose

To assess the relationship between obesity and early COVID-19 prognosis in octogenarians patients.

Methods

Patients were determined to have COVID-19 if they had a positive SARS-CoV-19 swab. We used logistic regression analyses to control for confounding by concomitant risk factors. Clinical characteristics and COVID-19 related outcomes (i.e. invasive mechanical ventilation [IMV], death and discharge by day 7 [D7]) were analyzed according to BMI status and age (older vs younger than 80 years).

Results

Among 601 patients with COVID-19 confirmed disease there 514 (85.5%) normal weight and 87 (14.5%) obese subjects (BMI >30 kg/m2). In a multivariable adjusted model, the primary outcome (IMV and/or death by D7) was significantly associated with obesity in the overall population (OR 2.19; 95% CI: 1.26–3.8). After multivariable adjustment, primary outcome by D7 was significantly associated with obesity in patients aged younger than 80 years (OR 2.54; 95% CI: 1.38–4.68), while such an association was no longer found in those aged 80 years and older (OR 0.42; 95% CI: 0.05–3.33).

Conclusions

Obesity is associated with poor early prognosis in patients with confirmed COVID19 disease. The deleterious impact of obesity on COVID-19 prognosis is no longer observed in the elderly aged 80 years and older. Very advanced age by itself must be considered as a major risk for severe COVID-19 outcomes in all people irrespective of BMI status.

Funding Acknowledgement

Type of funding sources: None.
Effect of exercise training on vascular function and endothelial repair in heart failure with preserved ejection fraction: results from the OptimEx trial
Authors: Gevaert A , Boehm B , Hartmann H , Goovaerts I , Stoop T , Van De Heyning C M , Beckers P J , Baldassari F , Mueller S , Duvinage A , Wisloff U , Adams V , Pieske B , Halle M , Van Craenenbroeck E M ,   OptimEx study group
Published: October 2021

Background

Exercise training improves peak oxygen uptake (VO2) in heart failure with preserved ejection fraction (HFpEF), but the underlying mechanisms are unknown. In other cardiovascular diseases, exercise training improves vascular function and increases levels of circulating endothelium-repairing cells. We aimed to investigate the effects of moderate continuous training (MCT) and high intensity interval training (HIIT) on vascular function and cellular endothelial repair in HFpEF.

Methods

This was a prespecified subanalysis of the Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure randomized trial. HFpEF patients (n=180) were randomized to HIIT, MCT or attention control. At baseline and after 12 weeks, we measured peak VO2, fingertip arterial tonometry (n=109), brachial artery flow-mediated dilation (n=59), aortic pulse wave velocity (n=94), and flow cytometry (n=136) for endothelial progenitor cells (CD45dimCD34+VEGFR2+) and angiogenic T cells (CD3+CD31+CD184+). Changes in these parameters were compared between groups using linear mixed models. Parameters were correlated using Spearman's rho.

Results

At 3 months, we did not observe significant differences between HIIT, MCT and control group regarding changes in vascular function throughout the vascular tree (fingertip arterial tonometry, brachial artery flow-mediated dilation and central arterial stiffness, Table 1) or levels of circulating endothelium-repairing cells (endothelial progenitor cells and angiogenic T cells, Table 1). Results were similar at 12 months and when restricting analysis to patients with at least 70% adherence to training sessions. Patients with higher peak VO2 at baseline had lower numbers of circulating endothelial progenitor cells (rho=−0.22, p=0.011).

Conclusions

In patients with HFpEF, exercise training did not change vascular function or levels of endothelium-repairing cells. Thus, improved vascular function likely does not contribute to the change in peak VO2 after training. These findings are in contrast with the benefits of exercise on vascular function in heart failure with reduced ejection fraction and coronary artery disease.

Funding Acknowledgement

Type of funding sources: Public grant(s) – EU funding. Main funding source(s): EU Framework Programme 7 Table 1