One-year initial efficacy and safety outcomes of the premounted dry-pericardium Vienna self-expandable transcatheter aortic valve system: A first-in-human VIVA feasibility study.

BACKGROUND: The dry-pericardium Vienna transcatheter aortic valve system is repositionable and retrievable, already premounted on the delivery system, eliminating the need for assembly and crimping of the device before valve implantation. METHODS: The VIVA first-in-human feasibility study, a prospective, nonrandomized, single-center trial, evaluated the Vienna aortic valve in 10 patients with severe symptomatic aortic stenosis, who were at intermediate or high surgical risk. This study, registered at ClinicalTrials.gov (NCT04861805), focused on the safety, feasibility, clinical and hemodynamic performance of the Vienna system up to 1-year follow-up. RESULTS: The mean patient age was 79 ± 5 years, 60% male. Valve sizes used: 26 mm (10%), 29 mm (30%), 31 mm (60%). Key hemodynamic improvements were significant: mean aortic valve pressure gradient (mmHg) decreased from 48.7 to 8.1, aortic valve area (cm2) increased from 0.75 to 1.91, and maximum jet velocity through the aortic valve (m/s) decreased from 4.41 to 1.95 (p < 0.0001). No moderate/severe paravalvular leakage was observed, and computed tomography scans revealed no evidence of hypo-attenuated leaflet thickening. The study recorded one life-threatening bleeding event, two cases requiring postprocedural pacemaker implantation, and three ischemic events, with only one causing lasting neurological impairment. Importantly, there were no cases of cardiovascular mortality and only one noncardiovascular death, which was confirmed as unrelated to the device. CONCLUSIONS: The study indicates the Vienna valve as a potential option for severe symptomatic aortic stenosis, designed to streamline the procedure and potentially lower healthcare costs by reducing resource and equipment needs, also procedural errors. Further research is essential to thoroughly evaluate its safety and efficacy.

Anterior basal left ventricular pseudoaneurysm in a single vessel disease.

INTRODUCTION: Left ventricular pseudoaneurysm is a rare but serious clinicopathologic entity. MATERIALS AND RESULTS: This article describes a case report of 51-year-old man who experienced recurrence of chest pain and dyspnea 4 months later after anterior ST elevation myocardial infarction of first diagonal branch. Anterior basal left ventricular pseudoaneurysm was diagnosed and successful surgical treatment was performed. One year after operation, patient has no cardiovascular events and remains in NYHA class II. CONCLUSION: Cardiac magnetic resonance should be performed, if there is a suspicion of left ventricular pseudoaneurysm from transthoracic echocardiography. Surgery is the treatment of choice in case of left ventricular pseudoaneuryms because untreated lesions carry a significantly high risk of rupture.

Global and regional right ventricular mechanics in repaired tetralogy of Fallot with chronic severe pulmonary regurgitation: a three-dimensional echocardiography study.

BACKGROUND: Data about the right ventricular (RV) mechanics adaptation to volume overload in patients with repaired tetralogy of Fallot (rToF) are limited. Accordingly, we sought to assess the mechanics of the functional remodeling occurring in the RV of rToF with severe pulmonary regurgitation. METHODS: We used three-dimensional transthoracic echocardiography (3DTE) to obtain RV data sets from 33 rToF patients and 30 age- and sex- matched controls. A 3D mesh model of the RV was generated, and RV global and regional longitudinal (LS) and circumferential (CS) strain components, and the relative contribution of longitudinal (LEF), radial (REF) and anteroposterior (AEF) wall motion to global RV ejection fraction (RVEF) were computed using the ReVISION method. RESULTS: Corresponding to decreased global RVEF (45 ± 6% vs 55 ± 5%, p < 0.0001), rToF patients demonstrated lower absolute values of LEF (17 ± 4 vs 28 ± 4), REF (20 ± 5 vs 25 ± 4) and AEF (17 ± 5 vs 21 ± 4) than controls (p < 0.01). However, only the relative contribution of LEF to global RVEF (0.39 ± 0.09 vs 0.52 ± 0.05, p < 0.0001) was significantly decreased in rToF, whereas the contribution of REF (0.45 ± 0.08 vs 0.46 ± 0.04, p > 0.05) and AEF (0.38 ± 0.09 vs 0.39 ± 0.04, p > 0.05) to global RVEF was similar to controls. Accordingly, rToF patients showed lower 3D RV global LS (-16.94 ± 2.9 vs -23.22 ± 2.9, p < 0.0001) and CS (-19.79 ± 3.3 vs -22.81 ± 3.5, p < 0.01) than controls. However, looking at the regional RV deformation, the 3D CS was lower in rToF than in controls only in the basal RV free-wall segment (p < 0.01). 3D RV LS was reduced in all RV free-wall segments in rToF (p < 0.0001), but similar to controls in the septum (p > 0.05). CONCLUSIONS: 3DTE allows a quantitative evaluation of the mechanics of global RVEF. In rToF with chronic volume overload, the relative contribution of the longitudinal shortening to global RVEF is affected more than either the radial or the anteroposterior components.

Multidisciplinary approach to rare primary cardiac sarcoma: a case report and review.

BACKGROUND: Undifferentiated pleomorphic sarcoma is a very rare and aggressive type of primary cardiac tumors. Most cardiac sarcomas result in rapid growth and quick death. According to different sources the median survival is typically 6 to 12 months. We are presenting a case of primary cardiac sarcoma with 26 months disease free survival following cytoreductive surgery and chemotherapy. CASE PRESENTATION: A 48-year-old woman with progressing symptoms of dyspnea and palpitations for over 2 months was referred to a cardiologist. With the help of echocardiography and cardiovascular magnetic resonance cardiac sarcoma was suspected. Open biopsy and cytoreductive surgery were performed, complete resection of the tumor was not possible. Histology revealed undifferentiated pleomorphic sarcoma. Seven cycles of chemotherapy with Doxorubicine and Ifosfamide were completed. Cardiovascular magnetic resonance revealed a complete response - only signs of fibrosis without any signs of tumor were visible. Follow ups with echocardiography, cardiovascular magnetic resonance and chest, abdomen and pelvic computed tomography is performed every 3 months. Twenty-six months from initial diagnosis the patient is still free of recurrence of tumor with no compromises of the quality of life. CONCLUSION: Standard chemotherapy together with cytoreductive surgery can have a complete response effect in undifferentiated pleomorphic sarcoma with unusual long-term survival.

Strain-encoded cardiac magnetic resonance imaging: a new approach for fast estimation of left ventricular function.

BACKGROUND: Recently introduced fast strain-encoded (SENC) cardiac magnetic resonance (CMR) imaging (fast-SENC) provides real-time acquisition of myocardial performance in a single heartbeat. We aimed to test the ability and accuracy of real-time strain-encoded CMR imaging to estimate left ventricular volumes, ejection fraction and mass. METHODS: Thirty-five subjects (12 healthy volunteers and 23 patients with known or suspected coronary artery disease) were investigated. All study participants were imaged at 1.5 Tesla MRI scanner (Achieva, Philips) using an advanced CMR study protocol which included conventional cine and fast-SENC imaging. A newly developed real-time free-breathing SENC imaging technique based on the acquisition of two images with different frequency modulation was employed. RESULTS: All parameters were successfully derived from fast-SENC images with total study time of 105 s (a 15 s scan time and a 90 s post-processing time). There was no significant difference between fast-SENC and cine imaging in the estimation of LV volumes and EF, whereas fast-SENC underestimated LV end-diastolic mass by 7%. CONCLUSION: The single heartbeat fast-SENC technique can be used as a good alternative to cine imaging for the precise calculation of LV volumes and ejection fraction while the technique significantly underestimates LV end-diastolic mass.

Fatty metaplasia quantification and impact on regional myocardial function as assessed by advanced cardiac MR imaging.

OBJECTIVE: This study aimed to investigate the advantages of recently developed cardiac imaging techniques of fat-water separation and feature tracking to characterize better individuals with chronic myocardial infarction (MI). MATERIALS AND METHODS: Twenty patients who had a previous MI underwent CMR imaging. The study protocol included routine cine and late gadolinium enhancement (LGE) technique. In addition, mDixon LGE imaging was performed in every patient. Left ventricular (LV) circumferential (EccLV) and radial (ErrLV) strain were calculated using dedicated software (CMR42, Circle, Calgary, Canada). The extent of global scar was measured in LGE and fat-water separated images to compare conventional and recent CMR imaging techniques. RESULTS: The infarct size derived from conventional LGE and fat-water separated images was similar. However, detection of lipomatous metaplasia was only possible with mDixon imaging. Subjects with fat deposition demonstrated a significantly smaller percentage of fibrosis than those without fat (10.68 ± 5.07% vs. 13.83 ± 6.30%; p = 0.005). There was no significant difference in EccLV or ErrLV between myocardial segments containing fibrosis only and fibrosis with fat. However, EccLV and ErrLV values were significantly higher in myocardial segments adjacent to fibrosis with fat deposition than in those adjacent to LGE only. CONCLUSIONS: Advanced CMR imaging ensures more detailed tissue characterization in patients with chronic MI without a relevant increase in imaging and post-processing time. Fatty metaplasia may influence regional myocardial deformation especially in the myocardial segments adjacent to scar tissue. A simplified and shortened myocardial viability CMR protocol might be useful to better characterize and stratify patients with chronic MI.

Heart rate variability after radiofrequency ablation of epicardial ganglionated plexuses on the ovine left atrium.

BACKGROUND: Ganglionated plexuses (GP) are terminal parts of cardiac autonomous nervous system (ANS). Radiofrequency ablation (RFA) for atrial fibrillation (AF) possibly affects GP. Changes in heart rate variability (HRV) after RFA can reflect ANS modulation. METHODS: Epicardial RFA of GP on the left atrium (LA) was performed under the general anesthesia in 15 mature Romanov sheep. HRV was used to assess the alterations in autonomic regulation of the heart. A 24 - hour ECG monitoring was performed before the ablation, 2 days after it and at each of the 12 following months. Ablation sites were evaluated histologically. RESULTS: There was an instant change in HRV parameters after the ablation. A standard deviation of all intervals between normal QRS (SDNN), a square root of the mean of the squared differences between successive normal QRS intervals (RMSSD) along with HRV triangular index (TI), low frequency (LF) power and high frequency (HF) power decreased, while LF/HF ratio increased. Both the SDNN, LF power and the HF power changes persisted throughout the 12 - month follow - up. Significant decrease in RMSSD persisted only for 3 months, HRV TI for 6 months and increase in LF/HF ratio for 7 months of the follow - up. Afterwards these three parameters were not different from the preprocedural values. CONCLUSIONS: Epicardial RFA of GP's on the ovine left atrium has lasting effect on the main HRV parameters (SDNN, HF power and LF power). The normalization of RMSSD, HRV TI and LF/HF suggests that HRV after epicardial RFA of GPs on the left atrium might restore over time.

Cardiovascular magnetic resonance feature tracking in small animals - a preliminary study on reproducibility and sample size calculation.

BACKGROUND: Cardiovascular magnetic resonance feature tracking (CMR-FT) is a novel tissue tracking technique developed for noninvasive assessment of myocardial motion and deformation. This preliminary study aimed to evaluate the observer's reproducibility of CMR-FT in a small animal (mouse) model and define sample size calculation for future trials. METHODS: Six C57BL/6 J mice were selected from the ongoing experimental mouse model onsite and underwent CMR with a 3 Tesla small animal MRI scanner. Myocardial deformation was analyzed using dedicated software (TomTec, Germany) by two observers. Left ventricular (LV) longitudinal, circumferential and radial strain (EllLAX, EccSAX and ErrSAX) were calculated. To assess intra-observer agreement data analysis was repeated after 4 weeks. The sample size required to detect a relative change in strain was calculated. RESULTS: In general, EccSAX and EllLAX demonstrated highest inter-observer reproducibility (ICC 0.79 (0.46-0.91) and 0.73 (0.56-0.83) EccSAX and EllLAX respectively). In contrast, at the intra-observer level EllLAX was more reproducible than EccSAX (ICC 0.83 (0.73-0.90) and 0.74 (0.49-0.87) EllLAX and EccSAX respectively). The reproducibility of ErrSAX was weak at both observer levels. Preliminary sample size calculation showed that a small study sample (e.g. ten animals to detect a relative 10% change in EccSAX) could be sufficient to detect changes if parameter variability is low. CONCLUSIONS: This pilot study demonstrates good to excellent inter- and intra-observer reproducibility of CMR-FT technique in small animal model. The most reproducible measures are global circumferential and global longitudinal strain, whereas reproducibility of radial strain is weak. Furthermore, sample size calculation demonstrates that a small number of animals could be sufficient for future trials.

Left atrial mechanics in patients with acute STEMI and secondary mitral regurgitation: A prospective pilot CMR feature tracking study.

BACKGROUND AND OBJECTIVE: Left atrium (LA) is an important biomarker of adverse cardiovascular outcomes and cerebrovascular events. This study aimed to evaluate LA myocardial deformation using cardiac magnetic resonance feature tracking (CMR-FT) in patients with acute ST-segment elevation myocardial infarction (STEMI) and secondary mitral regurgitation (MR). Additionally, to assess interobserver and intraobserver variability of the technique. MATERIALS AND METHODS: Twenty patients with STEMI underwent CMR with a 1.5Tesla MRI scanner. According to the presence of MR patients were divided into two groups: MR(+) and MR(-). Total LA strain (ɛs), passive LA strain (ɛe), and active LA strain (ɛa) were obtained. Additionally, total, passive and active strain rates (SRs, SRe, and SRa) were calculated. To assess interobserver agreement data analysis was performed by second independent observer. RESULTS: LA volumetric and functional parameters were similar in both groups. All LA strain values were significantly higher in patients with MR: ɛs (27.67±10.25 for MR(-) vs. 32.80±6.95 for MR(+); P=0.01), ɛe (15.29±7.30 for MR(-) vs. 19.22±6.04 for MR(+); P=0.01) and ɛa (12.38±4.23 for MR(-) vs. 14.44±5.19 for MR(+); P=0.03). Only SRe significantly increased in patients with MR (-0.57±0.24 for MR(-) vs. -0.70±0.20 for MR(+); P=0.01). All LA deformation parameters demonstrated high interobserver and intraobserver agreement. CONCLUSIONS: Conventional volumetric and functional LA parameters do not detect early changes in LA performance in patients with STEMI and secondary MR. In contrast, LA reservoir, passive and active strain are significantly higher in patients with MR. Only peak early negative strain rate substantially increases during secondary MR. LA deformation parameters derived from conventional cine images using CMR-FT technique are highly reproducible.

N-carboxymethyllysine as a biomarker for coronary artery disease and age-related macular degeneration.

BACKGROUND AND OBJECTIVE: An association between coronary artery disease (CAD) and age-related macular degeneration (ARMD) has long been postulated, but exact mechanisms remain unclear. The global prevalence of CAD and ARMD increases and early biomarkers for early diagnosis of these diseases are necessary. The aim of this study was to investigate the plasma level of oxidative stress biomarker CML in patients with and without angiographic findings of atherosclerosis in the coronary arteries (CADath+ and CADath-, respectively) and to assess if there was an association of CAD with ARMD. MATERIALS AND METHODS: The study enrolled 233 subjects. Based on cardiologic and ophthalmologic examinations, the patients were divided into four subgroups: CADath+ARMD+, CADath+ARMD-, CADath-ARMD+, and CADath-ARMD-. The enzyme-linked immunosorbent assay was used for the measurement of plasma CML levels. Serum lipid levels were determined by an automatic analyzer using conventional enzymatic methods. RESULTS: CADath+ patients had higher CML concentration compared to CADath- subjects (1.04±0.6 vs. 0.83±0.4ng/mL, P<0.001). The highest mean CML level (1.12±0.7ng/mL) was found in CADath+ARMD+ patients. The mean plasma CML concentration was higher in subjects with any of the analyzed diseases compared to CADath-ARMD- subjects. A significant positive association of CADath+ (OR=2.50, 95% CI 1.60-3.90, P=0.0001), ARMD (OR=2.08, 95% CI 1.40-3.11, P=0.0001) and both analyzed diseases (OR=4.67, 95% CI 2.29-9.53, P=0.0001) with an increased level of plasma CML in a logistic regression model adjusting by age was identified. CONCLUSIONS: The level of CML, an oxidative stress biomarker, reflects the presence of atherosclerosis in coronary arteries and shows a possible link between ARMD and CADath+ via oxidative status.

Association of major cardiovascular risk factors with the development of acute coronary syndrome in Lithuania.

Cardiovascular (CV) disease remains the leading cause of death in Lithuania. Timely recognition of CV risk factors and intervention to reduce these risk factors is of absolute importance to prevent coronary heart disease and reduce its burden on society. This study aimed to compare the prevalence of major CV risk factors in general population and acute coronary syndrome (ACS) patients and to determine their association with the development of ACS. Five hundred and twenty-three ACS patients and 645 age- and gender-matched control subjects were enrolled in the study. Smoking, dyslipidaemia, diabetes, and hypertension, but not overweight or obesity, were significantly more prevalent in the ACS patients, compared with control group. The prevalence of smoking, overweight or obesity, and dyslipidaemia were significantly higher in younger patients. Hypertension was highly prevalent in all age subgroups. More than a half of all patients aged <45 years had three or four CV risk factors. Smoking [odds ratio (OR), 7.03, P < 0.0001], hypertension (OR, 1.82; P = 0.001), dyslipidaemia (OR, 1.99; P < 0.0001), and diabetes (OR, 2.30; P < 0.001) were significantly associated with ACS. Significant association of traditional CV risk factors, such as smoking, dyslipidaemia, hypertension, and diabetes with ACS, and high prevalence of these risk factors, especially in younger individuals, calls for attention, and implementation of prevention programmes to reduce the burden of CV morbidity and mortality in Lithuania.

Detection and evaluation of ventricular repolarization alternans: an approach to combined ECG, thoracic impedance, and beat-to-beat heart rate variability analysis.

BACKGROUND AND OBJECTIVE: Beat-to-beat alteration in ventricles repolarization reflected by alternans of amplitude and/or shape of ECG S-T,T segment (TWA) is known as phenomena related with risk of severe arrhythmias leading to sudden cardiac death. Technical difficulties have caused limited its usage in clinical diagnostics. Possibilities to register and analyze multimodal signals reflecting heart activity inspired search for new technical solutions. First objective of this study was to test whether thoracic impedance signal and beat-to-beat heart rate reflect repolarization alternans detected as TWA. The second objective was revelation of multimodal signal features more comprehensively representing the phenomena and increasing its prognostic usefulness. MATERIALS AND METHODS: ECG, and thoracic impedance signal recordings made during 24h follow-up of the patients hospitalized in acute phase of myocardial infarction were used for investigation. Signal morphology variations reflecting estimates were obtained by the principal component analysis-based method. Clinical outcomes of patients (survival and/or rehospitalization in 6 and 12 months) were compared to repolarization alternans and heart rate variability estimates. RESULTS: Repolarization alternans detected as TWA was also reflected in estimates of thoracic impedance signal shape and variation in beat-to-beat heart rate. All these parameters showed correlation with clinical outcomes of patients. The strongest significant correlation showed magnitude of alternans in estimates of thoracic impedance signal shape. CONCLUSIONS: The features of ECG, thoracic impedance signal and beat-to-beat variability of heart rate, give comprehensive estimates of repolarization alternans, which correlate, with clinical outcomes of the patients and we recommend using them to improve diagnostic reliability.

The Effect of Platelet Activity, ABCB1 Genetic Polymorphism, and Renal Function on the Development of Ticagrelor-Related Dyspnea in Patients with Acute Coronary Syndrome.

Purpose: The aim of this study was to determine the effect of ABCB1 genetic polymorphism and renal function on the occurrence of ticagrelor-related dyspnea. Patients and Methods: A total of 299 patients with acute with type 1, 2, or 3 myocardial infarction (with and without ST-segment elevation), who underwent coronary angiography and PTCA with stent implantation and were treated with antiplatelet drugs (ticagrelor and aspirin), were enrolled in this prospective study. For all enrolled patient's platelet aggregation (induction with high-sensitivity adenosine diphosphate, ADP HS) testing was performed using a MULTIPLATE® analyzer. Venous blood was also collected for genotyping. Results: Patients experiencing ticagrelor-related dyspnea had lower ADP HS value (ADP HS ≤ 19.5 U; OR = 2.254; P = 0.009), higher creatinine concentration (>90 µmol/l; OR = 3.414; P = 0.019), and lower GFR value (<60 mL/min/1.73 m2; OR = 2.211; P = 0.035). ABCB1 T allele was associated with ticagrelor-related dyspnea (OR = 2.550; P = 0.04). Conclusion: Ticagrelor-related dyspnea was found to be related to low platelet aggregation, increased plasma creatinine concentration, decreased GFR, and ABCB1 T allele. Carriers of the ABCB1 T allele had a higher plasma creatinine concentration that could be associated with an inhibitory effect of ticagrelor on P-glycoprotein function.

SCARB1 single nucleotide polymorphism (rs5888) is associated with serum lipid profile and myocardial infarction in an age- and gender-dependent manner.

BACKGROUND: Mutation in SCARB1 gene, exon 8 rs5888, has been associated with altered lipid levels and cardiovascular risk in humans though the results have been inconsistent. We analysed the impact of SCARB1 single nucleotide polymorphism (SNP) rs5888 with plasma lipid profile and association with coronary artery disease (CAD) in a Lithuanian population characterized by high morbidity and mortality from CAD and high prevalence of hypercholesterolemia. METHODS: The study included 1976 subjects from a random sample (reference group) and an myocardial infarction (MI) group of 463 patients. Genotyping of SCARB1 (rs5888) was carried out using the real-time polymerase chain reaction method. RESULTS/PRINCIPAL FINDINGS: Analysis of rs5888 C/T gene polymorphism in the reference group revealed that male TT genotype carriers (25-74 years) had significantly higher total cholesterol and triglyceride concentrations (5.70 mmol/l vs. 5.49 mmol/l; p = 0.036, and 1.70 mmol/l vs. 1.40 mmol/l, p = 0.023, respectively) than CT carriers and the oldest males (65-74 years) TT carriers had significantly higher high density lipoprotein cholesterol concentrations in comparison to heterozygous (1.52 mmol/l vs. 1.36 mmol/l, p = 0.033). The youngest female (25-44 years) TT genotype carriers had significantly lower low density lipoprotein cholesterol concentrations in comparison to C homozygous (2.59 mmol/l vs. 2.92 mmol/l, p = 0.023). The frequency of the SCARB1 TT genotype in the oldest male MI group (65-74 years) was significantly lower than in the corresponding reference group subjects (9.4% vs. 22.3%, p = 0.006). SCARB1 TT genotype was associated with decreased odds of MI in males aged 65-75 years (OR = 0.24, 95% CI 0.10-0.56, p = 0.001). CONCLUSIONS/SIGNIFICANCE: SCARB1 polymorphism is associated with lipid metabolism and CAD in an age- and gender- dependent manner. Analysis of SCARB1 SNP rs5888 C/T genotypes revealed an atheroprotective phenotype of lipid profile in older men and in young women TT genotype carriers in the reference group. SCARB1 TT genotype was associated with decreased odds of MI in aged men.

Early Safety and Performance of the Premounted Dry-Pericardium Vienna Self-Expandable Transcatheter Aortic Valve System: 30-Day Outcomes of the First-in-Human VIVA Feasibility Study.

The purpose of this first-in-human (FIH) study was to determine the safety and feasibility of the transfemoral premounted dry-pericardium Vienna Self-Expandable Supra-Annular Aortic Valve System. This novel system is repositionable and retrievable and comes already premounted on the delivery system, eliminating the need for assembly and crimping of the device before valve implantation. This is a prospective, nonrandomized, single-arm, single-center, first-stage FIH feasibility study, which will be followed by a second-stage pivotal, multicenter, multinational study in symptomatic patients with severe aortic stenosis. The first-stage FIH study evaluated the safety and feasibility of the device in 10 patients with severe aortic stenosis based on recommendations by the Valve Academic Research Consortium-2 for transcatheter aortic valve implantations. The mean patient age was 79 ± 5 years, 60% were male, and all patients were in New York Heart Association functional class II to III. The primary safety end point was successful when all patients were alive at 30-day follow-up. Device and technical success were observed in all patients. Two patients had a stroke, 1 of which occurred 5 days after the procedure. New permanent pacemakers were implanted in 2 patients (22.2%), of which only 1 was because of complete heart block. Only 1 patient (10%) had moderate paravalvular leak at 30 days. After the procedure, the mean aortic valve gradient decreased from 48.7 ± 10.8 mm Hg to 8.8 ± 4.3 mm Hg. In conclusion, this FIH feasibility study demonstrates successful procedural feasibility, with no 30-day mortality and favorable valve hemodynamic performance, leading to an improvement in quality of life. ClinicalTrials.gov identifier NCT04861805.

Safety and performance of the Vienna self-expandable transcatheter aortic valve system: 6-month results of the VIVA first-in-human feasibility study.

Background: The novel Vienna TAVI system is repositionable and retrievable, already pre-mounted on the delivery system, eliminating the need for assembly and crimping of the device prior to valve implantation. Aims: The purpose of this first-in-human feasibility study was to determine the safety, feasibility, clinical and hemodynamic performance of the Vienna TAVI system at 6-month follow-up. (ClinicalTrials.gov identifier NCT04861805). Methods: This is a prospective, non-randomized, single-arm, single-center, first-stage FIH feasibility study, which is followed by a second-stage pivotal, multicenter, multinational study in symptomatic patients with severe aortic stenosis (SAS). The first-stage FIH study evaluated the safety and feasibility, clinical and hemodynamic performance of the device in 10 patients with SAS based on recommendations by the VARC-2. Results: All patients were alive at 3-month follow-up. 1 non-cardiovascular mortality was reported 5 months after implantation. There were no new cerebrovascular events, life-threatening bleeding or conduction disturbances observed at 6-month follow-up. The mean AV gradient significantly decreased from 48.7 ± 10.8 to 7.32 ± 2.0 mmHg and mean AVA increased from 0.75 ± 0.18 to 2.16 ± 0.42 cm2 (p < 0.00001). There was no incidence of moderate or severe total AR observed. In the QoL questionnaires, the patients reported a significant improvement from the baseline 12-KCCQ mean score 58 ± 15 to 76 ± 20. NYHA functional class improved in two patients, remained unchanged in one patient. There was an increase in mean 6-min-walk distance from baseline 285 ± 97 to 347 ± 57 m. Conclusions: This study demonstrates that using Vienna TAVI system has favourable and sustained 6-month safety and performance outcomes in patients with symptomatic severe aortic stenosis.

Left atrial strain rate: marker of hemodynamically significant coronary artery stenosis?

Aim: To assess the diagnostic value of left atrial deformation parameters during dobutamine stress echocardiography to predict significant coronary artery stenosis in patients with moderate pretest probability of coronary artery disease (CAD). Materials & methods: Rest and stress echocardiography were performed on 61 patients with a moderate and high probability of CAD. Based on presence of CAD patients were divided into pathological and nonpathological groups. Results: Early diastolic strain rate (LAe SR) was significantly lower among the pathological group at high dobutamine doses. LAe SR was evaluated with receiver operating characteristic curve and threshold prognostic value was set of -2.05 (sensitivity 78%, specificity 50%, area under the curve 0.638; p = 0.026). Conclusion: Measuring LAe SR has predictive value and might be a helpful parameter in assessing ischemia.

Relationships of Whole-Heart Myocardial Mechanics and Cardiac Morphometrics by Transthoracic Echocardiography with Main Prognostic Factors of Heart Failure in Non-Ischemic Dilated Cardiomyopathy.

BACKGROUND: there are many prognostic factors of heart failure (HF) based on their evaluation from imaging, to laboratory tests. In clinical practice, it is crucial to use widely available, cheap, and easy-to-use prognostic factors, such as left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) functional class, 6 min walk test (6MWT), B-type natriuretic peptide (BNP), etc. We sought to evaluate the relationships between whole-heart myocardial mechanics and cardiac morphometrics with the main commonly used prognostic factors of HF in patients with non-ischemic dilated cardiomyopathy (NIDCM). METHODS AND RESULTS: two-dimensional (2D) echocardiography for myocardial mechanics (global longitudinal, radial, and circumferential strains of the left ventricle; right ventricular longitudinal strain; strain values of reservoir, conduit, and contraction function of both atria) and cardiac morphometric (diameters and volumes of both atria and ventricles) parameters were performed, and the HF main traditional prognostic factors were identified. We assessed 109 patients (68.8% male; 49.7 ± 10.5 years) with newly diagnosed NIDCM. Myocardial mechanics and morphometrics were weakly correlated with the patient's age, gender, and smoking (R = 0.2, p < 0.05). Stronger relationships were observed with NYHA class, 6MWT, and BNP (the strongest correlations were with LVEF: R = -0.499, R 0.462, R = -0.461, p < 0.001, respectively). There were moderately strong correlations with LVEF and other whole-heart myocardial mechanics or morphometrics. Moreover, LVEF with global regurgitation volume (GRV) and right ventricle free wall longitudinal strain (RVFWLS) were the most usually detected parameters in multivariate analysis to be associated with changes in HF prognostic factors. CONCLUSIONS: in NIDCM patients, the main prognostic factors of HF are correlated with whole-heart myocardial mechanics and morphometrics. However, LVEF, GRV, and RVFWLS are the most usually found 2D echocardiographic factors associated with changes in HF prognostic factors.

Fatigue in patients with coronary artery disease: association with thyroid axis hormones and cortisol.

OBJECTIVE: In people with coronary artery disease, the association between endocrine measures and fatigue is not well understood. We evaluated possible associations of fatigue and exercise capacity with function of adrenal axis and thyroid axis. METHODS: Sixty-five men and 18 women (mean age 55 years) attending a rehabilitation program were examined using the Multidimensional Fatigue Inventory, Dutch Exertion Fatigue Scale, and the Hospital Anxiety and Depression Scale. Exercise capacity was measured using a bicycle ergometer procedure. Serum concentrations of free triiodothyronine (T3), free thyroxine (T4), morning cortisol, afternoon cortisol, and change in cortisol concentrations (ΔCortisol) were measured. RESULTS: In univariate regression analysis, lower free T4 concentrations were associated with general and exertion fatigue, lower free T3 concentrations were associated with general and physical fatigue, and lower ΔCortisol was associated with mental fatigue. After adjusting for age, sex, body mass index, hypertension, previous myocardial infarction, heart failure, diabetes, New York Heart Association functional class, depressive symptoms, and anxiety symptoms, lower free T3 concentrations remained associated with physical fatigue (ß = -.224, p = .03); lower free T4 concentrations, with exertion fatigue (ß = -.219, p = .03); and lower morning cortisol and lower ΔCortisol concentrations, with mental fatigue (ß = -.193 [p = .03] and ß = -.180 [p =.04], respectively). Exercise capacity was not associated with endocrine factors. CONCLUSIONS: In coronary artery disease patients, increased thyroid hormone concentrations are associated with decreased physical fatigue and decreased exertion fatigue, and increased cortisol concentrations with decreased mental fatigue. Exercise capacity is not associated with endocrine factors.

Does longitudinal strain predict left ventricular remodeling after myocardial infarction?

BACKGROUND: One of the most prognostically significant consequences of acute myocardial infarction (AMI) is the development of an adverse left ventricular (LV) remodeling. OBJECTIVES: The purpose of our study was to evaluate a feasibility of speckle tracking imaging (STI), in particular, global longitudinal strain (Ls) in predicting LV remodeling after AMI. METHODS: A total of 82 AMI patients (mean age 57.6 ± 9.4) were included in the study. Within 48-72 hours of the onset of AMI and at a 4-month follow-up, two-dimensional echocardiography was performed. The apical two- and four-chamber views of the heart were analyzed offline using Echo Pac software for the assessment of strain by the STI method. LV remodeling was defined as a 15% increase from the baseline in LV end-diastolic volume. RESULTS: Twenty-eight patients (34.1%) with LV remodeling at 4-month follow-up had comparable baseline clinical and echocardiographic characteristics with 54 patients (without LV remodeling), except for a predominance of the anterior wall MI (P < 0.01), higher leukocyte count value at admission (P < 0.01), lower ejection fraction (P < 0.05), increased end-systolic volume (P < 0.05), and reduced global systolic Ls (P < 0.05). Multivariable logistic regression analysis revealed the systolic Ls as an independent determinant of LV remodeling after AMI. A receiver operating characteristic curve analysis showed that a cutoff value of -11.6% for the systolic Ls yielded a 78% sensitivity and a 73% specificity to predict LV remodeling in 4 months. CONCLUSIONS: Our study has shown that LV longitudinal strain assessed by STI is an independent predictor of LV remodeling after AMI.