Clinical outcomes of the Myval transcatheter heart valve system in patients with severe aortic valve stenosis: a two-year follow-up observational study.

Introduction: Limited data exist on long-term follow-up of severe aortic stenosis (SAS) patients who have undergone transcatheter aortic valve implantation (TAVI) with a new generation, balloon expandable Myval transcatheter heart valve (THV). Thus, we sought to investigate the performance and 2-year clinical outcome of the Myval THV system based on Valve Academic Research Consortium-3 (VARC-3) criteria. Material and methods: A multi-centre, registry-based, observational study was conducted, which included 207 consecutive degenerative SAS patients, from Turkey (n = 128), Italy (n = 58), and Greece (n = 21) (mean [standard deviation] 81 (7) years, 94 [45%] men; 73% NYHA III or IV; EuroSCORE II 5.2% [2.4%]); all patients underwent TAVI with Myval. Patients were followed up at 1 year and 2 years after implantation. Clinical and procedural outcomes were defined according to VARC-3 criteria. Results: Technical success was observed in 204 (99%), device success was observed in 189 (91%), early safety was observed in 161 (78%), and clinical efficacy was observed in 163 (79%) patients. The 30-day death rate was 7.7%; of these, 3.4% were due to cardiovascular reasons. All-cause and cardiovascular mortality rates were 9.7% and 4.3% at 1-year follow-up, and 17.4% and 9.7% at 2-year follow-up, respectively. Incidence of ≥ moderate paravalvular leak (PVL) at 30 days, 1 year and 2 years of follow-up were 3.4%, 4.3% and 4.8%. A total of 11.1% of patients required a permanent pacemaker implantation (PPI) at 30 days after implantation, while the cumulative rate of PPI at 2 years was 12.1%. Conclusions: In this cohort of patients with SAS, the Myval was found to be safe and effective in up to 2 years of follow-up.

Comparison of two self-expanding transcatheter heart valves for degenerated surgical bioprostheses: the AVENGER multicentre registry.

BACKGROUND: There is a lack of comparative data on transcatheter aortic valve implantation (TAVI) in degenerated surgical prostheses (valve-in-valve [ViV]). AIMS: We sought to compare outcomes of using two self-expanding transcatheter heart valve (THV) systems for ViV. METHODS: In this retrospective multicentre registry, we included consecutive patients undergoing transfemoral ViV using either the ACURATE neo/neo2 (ACURATE group) or the Evolut R/PRO/PRO+ (EVOLUT group). The primary outcome measure was technical success according to Valve Academic Research Consortium (VARC)-3. Secondary outcomes were 30-day all-cause mortality, device success (VARC-3), coronary obstruction (CO) requiring intervention, rates of severe prosthesis-patient mismatch (PPM), and aortic regurgitation (AR) ≥moderate. Comparisons were made after 1:1 propensity score matching. RESULTS: The study cohort comprised 835 patients from 20 centres (ACURATE n=251; EVOLUT n=584). In the matched cohort (n=468), technical success (ACURATE 92.7% vs EVOLUT 88.9%; p=0.20) and device success (69.7% vs 73.9%; p=0.36) as well as 30-day mortality (2.8% vs 1.6%; p=0.392) were similar between the two groups. The mean gradients and rates of severe PPM, AR ≥moderate, or CO did not differ between the groups. Technical and device success were higher for the ACURATE platform among patients with a true inner diameter (ID) >19 mm, whereas a true ID ≤19 mm was associated with higher device success - but not technical success - among Evolut recipients. CONCLUSIONS: ViV TAVI using either ACURATE or Evolut THVs showed similar procedural outcomes. However, a true ID >19 mm was associated with higher device success among ACURATE recipients, whereas in patients with a true ID ≤19 mm, device success was higher when using Evolut.

Transcatheter transseptal treatment of patients with severe mitral regurgitation using an atrial fixation mitral valve replacement technology.

BACKGROUND: Mitral regurgitation (MR) is the most common valvular heart disease worldwide with a 5-year mortality rate of 50 % with medical therapy alone. Several transcatheter mitral valve replacement (TMVR) devices are being investigated in clinical trials. Early evidence has demonstrated clinical benefits with a reduction in heart failure symptoms, low rates of residual MR, and reverse remodeling of the left ventricle (LV) over time. However, high anatomical screen failure rates limit its applicability. The primary reasons for the anatomical screen failure are risk of LV outflow tract obstruction, large mitral valve annulus size, and the presence of mitral annular calcification. Our clinical experiences using an atrial only fixation TMVR technology delivered via a transfemoral-transseptal approach is described. METHODS: Three consecutive patients with severe functional MR underwent TMVR implantation using an atrial only fixation technology and a low-profile transseptal delivery system. RESULTS: Technical success was achieved in 100 % of the patients with a clinically significant reduction in MR. Longer-term follow-up (up to 6-months) has demonstrated a sustained reduction in MR and significant improvement in quality of life for all patients. CONCLUSIONS: Longer-term outcomes in our patients showed persistent reduction in MR, sustained implant performance, and notable improvements in NYHA Class and quality of life. There were no major adverse events. Follow-up CT data showed no evidence of device-related thrombosis, with stable valve position and integrity. The atrial fixation TMVR technology may have benefits in preserving the dynamics of the native mitral valve annulus thereby reducing the overall risk of LVOT obstruction. SHORT ABSTRACT: We present a single-center experience of three consecutive patients with severe functional MR treated with the AltaValve using a low-profile transseptal delivery system. A clinically significant reduction in mitral regurgitation was achieved in all patients, and longer-term follow-up has demonstrated sustained clinical benefits.

Transcatheter Aortic Valve Implantation with the Portico Valve: 2-Year Outcomes of a Multicenter, Real-World Registry.

INTRODUCTION: The self-expanding, resheathable, repositionable transcatheter aortic heart valve Portico is being used successfully for transcatheter aortic valve implantation procedures (TAVI) in patients with severe aortic stenosis. The aim of this study was to evaluate outcomes at 2 years after TAVI with the Portico valve. METHODS: Multicenter registry of clinical, echocardiographic and survival data from consecutive patients treated with the Portico TAVI system (Abbott, Chicago, IL, USA) in three cath labs in Northern Greece and Epirus during 2017-2020. The primary end point was all-cause mortality at 24 months. Secondary end points included procedural outcomes (efficacy and safety) and echocardiographic measurements. RESULTS: A total of 90 patients (81 ± 6 years, 50% females, mean age 81 ± 6 years) were included in the registry. The indication for implantation was severe, symptomatic aortic stenosis (NYHA III, IV) in eighty-two (91.1%) and degeneration of a prosthetic aortic valve in eight (8.9%) patients. All patients were categorized as high surgical risk (mean Logistic Euroscore 25.9 ± 10, Euroscore II 7.7 ± 4.4 and STS score 10.8 ± 8.9). The procedure was performed transfemorally in all patients, under general anesthesia in 95.6%, under TOE guidance in 21.1%, with native valve predilatation in 46.7%, and the "resheath" option was used in 31.1% of the cases. The implantation was successful in 97.8% and there was a need for a second valve in 2.2% of the cases. Complications included permanent pacemaker implantation (16.7%), access cite complications (15.6%), arrythmias (23.3%), paravalvular leak (moderate 7.8%, severe 1.1%), acute kidney injury (7.8%), no strokes and one death during the procedure. Aortic valve peak velocity, peak and mean pressure gradients, were significantly reduced after the procedure. All-cause mortality at 1, 12 and 24 months was 4.4%, 6.7% and 7.8%, respectively. CONCLUSIONS: TAVI with the Portico system comprises an effective and safe solution for the management of severe, symptomatic aortic stenosis in high-risk surgical patients.

Updated knowledge and practical implementations of stress echocardiography in ischemic and non-ischemic cardiac diseases: An expert consensus of the Working Group of Echocardiography of the Hellenic Society of Cardiology.

Stress echocardiography (SE) is a well established and valid technique, widely used for the diagnostic evaluation of patients with ischemic and nonischemic cardiac diseases. This statement of the Echocardiography Working Group of the Hellenic Society of Cardiology summarizes the consensus of the writing group regarding the applications of SE, based on the expertise of their members and on a critical review of present medical literature. The main objectives of the consensus document include a comprehensive review of SE methodology and training-which focus on the preparation, the protocols used, the analysis of the SE images, and updated, evidence-based knowledge about SE applications on ischemic and nonischemic heart diseases, such as in cardiomyopathies, heart failure, and valvular heart disease.

Simultaneous implantation of MitraClip devices in a patient with severe mitral and tricuspid valve regurgitation.

We present a case of an 84-year old patient with severe mitral and tricuspid regurgitation with a lot of cormobidities who underwent a simultaneous transfemoral (one approach) mitral and tricuspid valve repair using the MitraClip system.

Is there a prognostic relevance of electrophysiological studies in bundle branch block patients?

BACKGROUND: The present European guidelines suggest a diagnostic electrophysiological (EP) study to determine indication for cardiac pacing in patients with bundle branch block and unexplained syncope. We evaluated the prognostic relevance of an EP study for mortality and the development of permanent complete atrioventricular (AV) block in patients with symptomatic bifascicular block and first-degree AV block. HYPOTHESIS: The HV interval is a poor prognostic marker to predict the development of permanent AV block in patients with symptomatic bifascicular block (BFB) and AV block I°. METHODS: Thirty consecutive patients (mean age, 74.8 ± 8.6 years; 25 males) with symptomatic BFB and first-degree AV block underwent an EP study before device implantation, according to current guidelines. For 53 ± 31 months, patients underwent yearly follow-up screening for syncope or higher-degree AV block. RESULTS: Thirty patients presented with prolonged HV interval during the EP study (mean, 82.2 ± 20.1 ms; range, 57-142 ms), classified into 3 groups: group 1, <70 ms (mean, 62 ± 4 ms; range, 57-67 ms; n = 7), group 2, >70 to ≤100 ms (mean, 80 ± 8 ms; range, 70-97 ms; n = 18), and group 3, >100 ms (mean, 119 ± 14 ms; range, 107-142 ms; n = 5). According to the guidelines, patients in groups 2 and 3 received a pacemaker. The length of the HV interval was not associated with the later development of third-degree AV block or with increased mortality. CONCLUSIONS: Our present study suggests that an indication for pacemaker implantation based solely on a diagnostic EP study with prolongation of the HV interval is not justified.

A new experimentally validated formula to calculate the QT interval in the presence of left bundle branch block holds true in the clinical setting.

BACKGROUND: The evaluation of the QT interval in the presence of left bundle branch block (LBBB) is associated with the challenge to discriminate native QT interval from the prolongation due to the increase in QRS duration. The newest formula to evaluate QT interval in the presence of LBBB suggests: modified QT during LBBB = measured QT interval minus 50% of LBBB duration. The purpose of this study is therefore to validate the abovementioned formula in the clinical setting. METHODS: Validation in two separate groups of patients: Patients who alternated between narrow QRS and intermittent LBBB and patients with narrow QRS who developed LBBB after transcatheter aortic valve implantation (TAVI). RESULTS: The acquired mean native QTc intervals and those calculated by the presented formula displayed no significant differences (p > .99 and p > .75). CONCLUSIONS: In this study we proved for the first time the validity and applicability of the experimentally acquired formula for the evaluation of the QT interval in the presence of LBBB in a clinical setting.

Spot diagnosis of inferior axis and concordant R-pattern predicts left ventricular inflow tract tachycardia: Ablation from the great cardiac vein of an underdiagnosed entity.

BACKGROUND: The present literature holds an enormous variation concerning origin and ablation site of idiopathic ventricular arrhythmias (VA), ranging from 2.5 to 15% for the origin within the coronary venous system (CVS). The aim of the study was to detect positive predictive ECG morphology patterns to discriminate VA stemming from the CVS. METHODS: 110 consecutive patients (P) with 111 premature ventricular capture beat (PVC) morphologies undergoing successful ablation for VA were retrospectively analyzed concerning their ECG patterns. RESULTS: 20/110 P (18%) displayed their VA origin in the CVS with anterior/anterolateral left ventricular inflow tract (LVIT) (epicardial/GCV) in 16 P (14%), anterior/anterolateral LVIT (endo- and epicardial/GCV) in 3 P (3%), and anterior interventricular vein (AIV) 1 P (<1%). ECG morphology of all GCV cases demonstrated an inferior axis and concordant R-pattern in all precordial leads resulting in 100% sensitivity. One VA demonstrating this pattern was ablated outside at the LVOT resulting in 95% specificity for origin in the anterior/anterolateral LVIT. 3/20 P that were ablated in the CVS required additional endocardial ablation from the anterior/anterolateral LVIT resulting in 80% specificity for sole successful ablation in the CVS. CONCLUSION: An inferior axis and concordant R-pattern in all precordial leads serve as diagnostic markers for an LVIT origin in the surface ECG and suggest a high primary ablation success via the GCV.

Expression of NO Synthase Under Medication with Cyclosporine A, Mycophenolate Mofetil, and Tacrolimus during Development of Transplant Vasculopathy on Rat Cardiac Allograft.

OBJECTIVE: The transplant vasculopathy as a sign of chronic graft rejection affects both the epicardial and the intramyocardial arteries of the graft. This is at least partially mediated by NO synthases. The aim of this study was to assess possible protective effects of cyclosporine A (CsA), tacrolimus (FK506), and mycophenolate mofetil (MMF) on the expression of NO synthases in an experimental transplant rat model. AIMS: Heart transplantation was performed in 322 rats. These were randomly assigned to four equal groups (control, CsA, FK506, MMF). Recipients were monitored up to 60 days after transplantation, while transplanted hearts were recovered at certain time points for analysis. Expression and staining intensity for endothelial nitric oxide synthases (e-nos) and inducible nitric oxide synthases (i-nos) were analyzed in epicardial and intramyocardial vessels in each group. RESULTS: All employed drugs led to a significant reduction of expression or staining intensity of i-nos and e-nos. MMF was most effective in reduction in expression of both NO synthases. CONCLUSIONS: These results imply that all described drugs prevent endothelial impairment induced by toxicity of NO and thereby prevent transplant vasculopathy. MMF seems to be the most effective drug.

Q Wave in the Inferior Leads: There Is More Than Scar.

Q waves can regularly be observed in the 12-lead electrocardiogram either due to heart axis underlying pathology such as subacute myocardial infarction, myocardial scar, or accessory pathways. Rarely, other entities such as circumscribed hypertrophy can induce significant Q wave and represent an important differential diagnosis especially in younger patients. In the setting of atypical chest pain determination of the correct diagnosis can be challenging. Therefore, circumscribed hypertrophy should be taken into account to avoid unnecessary invasive procedures.

U wave during supraventricular tachycardia: simulation of a long RP tachycardia and hiding the common type AVNRT.

The main tool for the differentiation of supraventricular tachycardia is the 12-lead electrocardiogram (ECG). Especially differentiating the atrioventricular nodal reentrant tachycardia (AVNRT) from the atrioventricular reentrant tachycardia (AVRT) due to concealed accessory pathway or from an atrial tachycardia (AT) is very important for catheter setting and ablation approach in an electrophysiological study. In our case we saw the occurrence of a U wave during tachycardia-simulating a pseudo P wave. This mimicked a long RP-tachycardia, although it was a common type AVNRT.

New formula for evaluation of the QT interval in patients with left bundle branch block.

BACKGROUND: Left bundle branch block (LBBB) and QT prolongation both are associated with a worse prognosis. LBBB lengthens the QT interval. To date it is not known whether QT prolongation during LBBB differs in repolarization from QT prolongation during narrow QRS. OBJECTIVE: The purpose of the present proof-of-concept-study was to develop a formula that allows comparison of the adjusted QT interval during LBBB with reference values and thereby allows interpretation of the QT interval irrespective of QRS widening. METHODS: Sixty consecutive patients with sinus rhythm (SR) and narrow QRS underwent electrophysiologic study for ablation. In all patients, the intrinsic QRS ,QT, and JT times were measured during SR, and ventricular pacing from both the right ventricular apex (RVA) and the right ventricular outflow tract (RVOT) caused LBBB. We determined prolongation of the QT during as compared to SR (ΔQT). ΔQT was then divided by the QRS length during pacing QRS (QRSb). This describes the percentage of the QRS duration at LBBB, which must be subtracted from the measured QT (QTb) to determine the modified QT interval (QTm). RESULTS: The ratio of ΔQT to paced QRS was calculated as 48.3% (RVA) and 48.8% (RVOT) (mean 48.5%). The ratio intrinsic of JTi to paced JT was 1.0055 (RVA) and 1.0087 (RVOT). There was no significant difference in intrinsic JT vs paced JT (P = .2). CONCLUSION: Right ventricular pacing causes prolongation of the QT due to a paced LBBB without prolongation of the JT time. In our study, we showed that QT prolongation caused by LBBB constitutes 48.5% of the QRS width. This is the value that must be subtracted from the measured QT in LBBB in order to estimate the modified QT. Thus, the resulting formula for "modified QT" estimation in LBBB is QTm = QTb - 48.5% * (QRSb).

Prevalence, clinical correlates and treatment of permanent atrial fibrillation among the elderly: insights from the first prospective population-based study in rural Greece.

To investigate the prevalence of permanent atrial fibrillation (AF), its clinical associated conditions and treatment status in the elderly population in rural Greece. 720 people (46.1% males) older than 65 years (mean age: 72.5 +/- 5.7 years) living in four villages in rural Greece were screened with an electrocardiogram (response rate: 90.5%) for the presence of permanent AF. They underwent a physical examination, including blood pressure (BP) measurement, and body mass index (BMI) calculation, in addition to an interview about their medical history, physical activity, smoking habits, alcohol consumption and medication use. Subjects with AF for whom anticoagulants were contraindicated were identified and stroke risk stratification was performed using the CHADS2 algorithm. The prevalence of permanent AF was 5% (6.6% among men and 3.6% among women) and it increased with age. In the entire population, ECG evidence of myocardial ischaemia and ventricular premature beats were independently associated with the presence of permanent AF (OR 5.266; 95% CI 2.22-12.49, P = 0.0001 and OR 2.61; 95% CI 1.059-6.432, P = 0.037, respectively), while female sex was independently associated with the absence of the AF (OR 0.327; CI 0.147-0.729, P = 0.006). From those patients who were eligible for anticoagulation, 40.6% were treated with anticoagulants, 34.3% were given antiplatelets therapy and the rest received no antithrombotic treatment. This is the first prospective study demonstrating the prevalence, clinical correlates and treatment status of permanent AF in Greece. These results confirm the high prevalence of permanent AF among the elderly and underscore the issue regarding anticoagulants underutilization.

Gender-specific differences in hypertension prevalence, treatment, control, and associated conditions among the elderly: data from a Greek population.

PURPOSE: In the present study we sought to assess the gender-specific prevalence, treatment rates, and control of hypertension, as well as to identify its associated conditions and additional cardiovascular (CV) risk factors, in a Greek population aged > or = 65 years old. METHODS: This is a population-based study including a clinical interview, an ECG recording, and blood pressure (BP) measurements by sphygmomanometer. RESULTS: The overall prevalence of hypertension was 83.3%, higher in females and increasing with age. In males, hypertension was independently associated with increased body mass index (BMI), a history of stroke, and myocardial infarction, while in females increased age, BMI, and a history of diabetes were independently associated with hypertension. A considerable proportion of hypertensives were treated (77.3%), while an effective control of BP was achieved in 42.5% of treated subjects. Despite the fact that hypertension treatment rates did not differ between the genders, control rates were lower among females. Finally, more hypertensive females presented additional CV risk factors than normotensives. CONCLUSION: Elderly females exhibit a higher prevalence of hypertension and are characterized by lower hypertension control compared to hypertensive males.

Prevalence of interatrial block in a general population of elderly people.

BACKGROUND: Interatrial block (IAB: P wave > or = 110 ms) is highly prevalent in people > or =65 years old living in a community. METHODS: We investigated 720 consecutive people age > or =65 years old, from the general population, with the intention of evaluating the prevalence of IAB in their electrocardiogram. After excluding 42 people with atrial fibrillation and atrial flutter (5%) or having a permanent pacemaker (0,83%), we evaluated the electrocardiograms of the remaining 678 people with sinus rhythm. RESULTS: We identified 400 (59%) persons with IAB with a similar distribution between men (58.5%) and women (59.4%). IAB was also identified in 347 from a total of 570 hypertensive people (60,9%) and only in 53 out of 108 (49.1%) nonhypertensive people (P = 0.015). CONCLUSIONS: The surprisingly large prevalence of the IAB in the general older population emphasizes the importance of the early recognition of this abnormality from the surface 12-lead electrocardiogram.