The Role of ECG Strain Pattern in Prognosis after TAVI: A Sub-Analysis of the DIRECT Trial.

BACKGROUND: The presence of an electrocardiographic (ECG) strain pattern-among other ECG features-has been shown to be predictive of adverse cardiovascular outcomes in asymptomatic patients with aortic stenosis. However, data evaluating its impact on symptomatic patients undergoing TAVI are scarce. Therefore, we tried to investigate the prognostic impact of baseline ECG strain pattern on clinical outcomes after TAVI. METHODS: A sub-group of patients of the randomized DIRECT (Pre-dilatation in Transcatheter Aortic Valve Implantation Trial) trial with severe aortic stenosis who underwent TAVI with a self-expanding valve in one single center were consecutively enrolled. Patients were categorized into two groups according to the presence of ECG strain. Left ventricular strain was defined as the presence of ≥1 mm convex ST-segment depression with asymmetrical T-wave inversion in leads V5 to V6 on the baseline 12-lead ECG. Patients were excluded if they had paced rhythm or left bundle branch block at baseline. Multivariate Cox proportional hazard regression models were generated to assess the impact on outcomes. The primary clinical endpoint was all-cause mortality at 1 year after TAVI. RESULTS: Of the 119 patients screened, 5 patients were excluded due to left bundle branch block. Among the 114 included patients (mean age: 80.8 ± 7), 37 patients (32.5%) had strain pattern on pre-TAVI ECG, while 77 patients (67.5%) did not exhibit an ECG strain pattern. No differences in baseline characteristics were found between the two groups. At 1 year, seven patients reached the primary clinical endpoint, with patients in the strain group demonstrating significantly higher mortality in Kaplan-Meier plots compared to patients without left ventricular strain (five vs. two, log-rank p = 0.022). There was no difference between the strain and no strain group regarding the performance of pre-dilatation (21 vs. 33, chi-square p = 0.164). In the multivariate analysis, left ventricular strain was found to be an independent predictor of all-cause mortality after TAVI [Exp(B): 12.2, 95% Confidence Intervals (CI): 1.4-101.9]. CONCLUSION: Left ventricular ECG strain is an independent predictor of all-cause mortality after TAVI. Thus, baseline ECG characteristics may aid in risk-stratifying patients scheduled for TAVI.

The management of patent foramen ovale in divers: where do we stand?

Diving is a fascinating activity, but it does not come without any cost; decompression illness (DCI) is one of the most frequent diseases occurring in divers. Rapid surfacing after diving causes alveolar rupture and bubbles release, which enter in the systemic circulation and could embolize numerous organs and tissues. The presence of patent foramen ovale (PFO) contributes to the passage of venous gas bubbles into the arterial circulation, increasing the risk of complications related to DCI. The diagnosis is established with a detailed medical history, a comprehensive clinical evaluation, and a multimodal imaging approach. Although the percutaneous closure of PFO is ambiguous for divers, as a primary prevention strategy, transcatheter management is considered as beneficial for DCI recurrence prevention. The aim of this study is to introduce the basic principles of DCI, to review the pathophysiological connection between DCI and PFO, to highlight the risk factors and the optimal treatment, and, last but not least, to shed light on the role of closure as primary and secondary prevention.

Nickel Hypersensitivity to Atrial Septal Occluders: Smoke Without Fire?

Nickel is one of the most common contact allergens worldwide; it is used as the main component of the devices used for atrial septal defects (ASDs) and patent foramen ovale (PFO) closure. Developing nickel hypersensitivity after PFO/ASD occlusion is significantly rarer described in medical literature than typical nickel contact sensitization. The exact pathophysiological mechanism of this "device syndrome" remains unknown, and many question the real incidence or even the existence of this clinical entity. Nevertheless, it has been associated with a wide spectrum of symptoms, including chest pain, migraines, palpitation, and dyspnea. Skin patch tests are the first-line approach to diagnose nickel hypersensitivity. However, diagnostic criteria for the device syndrome have not been developed, and diagnosis in reported cases is established by a process of elimination. Management-drug therapy (corticosteroids, clopidogrel, etc.) or even surgical explantation in severe cases-of patients developing such clinical manifestations after percutaneous PFO/ASD occlusion is empirical. Undoubtedly, endocardiac device-related nickel hypersensitivity requires more focused research to discover the underlying mechanism as well as to develop reliable prognostic tests for detecting high-risk patients and preventing severe nickel hypersensitivity reactions.

In vivo correlation between morphological characteristics of coronary plaques and functional characteristics of carotid arteries in acute coronary syndrome.

BACKGROUND: Carotid artery temperature heterogeneity (ΔΤ) measured by microwave radiometry (MWR) has been associated with future cardiovascular events including acute coronary syndromes. The vulnerable plaques of the coronary arterial tree, that can be ideally depicted by intracoronary imaging such as optical coherence tomography (OCT) have anatomical characteristics such as the thin fibrous cap (TCFA), that make them vulnerable to rupture. The scope of the study was to assess the implication of the carotid artery temperature heterogeneity on the culprit coronary plaque morphology in patients presenting with acute myocardial infarction. METHODS: 34 patients presented with an acute myocardial infarction were enrolled in the study. All patients underwent percutaneous coronary intervention (PCI) and OCT for the evaluation of the anatomical characteristics of the culprit lesion. After the completion of the PCI all patients underwent carotid ultrasound and MWR of both carotid arteries and thermal heterogeneity of the carotid arteries was assessed. Blood samples were collected for high sensitivity C-reactive protein (CRP) analysis. RESULTS: Thirty four patients, 21 with STEMI (61.76%) and 13 (38.23%) with NSTEMI, were included in the study. Patients with ruptured plaques had significantly increased hsCRP compared to patients that did not have a ruptured plaque (14.41±4.02 vs 9.9±2.5, P<0.005). Thermal heterogeneity, was significantly increased in ruptured plaques compared to no ruptured ones (1.01±0.31 vs 0.51±0.14°C, P=0.001), and in plaques with TCFA compared to those without a TCFA (0.82±0.37 vs 0.60±0.05°C, P=0.001). Diabetes mellitus, ΔΤ and hsCRP, were entered in the multivariate analysis, from which DM (OR 4.12; 95% CI 0.77-22.07; P=0.07) and ΔΤ (OR for 0.1°C increase 1.43; 95% CI 1.03-1.98; P=0.03) remained in the final analysis, and only ΔΤ was independently associated with the presence of the TCFA. Regarding plaque rupture, STEMI, hsCRP, and ΔT were entered in the multivariate analysis from which hsCRP (OR 1.51; 95% CI 0.99-2.28; P=0.051) and ΔΤ (OR for 0.1°C increase 3.40; 95% CI 1.29-8.96; P=0.013) remained in the final analysis with the ΔT being the only variable.

Long-Term Outcomes and Valve Performance in Patients Undergoing Transcatheter Aortic Valve Implantation.

Transcatheter aortic valve implantation (TAVI) is an established method for treating patients with aortic valve stenosis. We sought to determine the long-term clinical outcomes and performance of a self-expanding bioprosthesis beyond 5 years. Consecutive patients scheduled for TAVI were included in the analysis. Primary end points were all-cause and cardiovascular mortality, structural valve deterioration (SVD) and bioprosthetic valve failure (BVF), based on the VARC-2 criteria and consensus statement by ESC/EAPCI. The study prospectively evaluated 273 patients (80.61 ± 7.00 years old, 47% females) who underwent TAVI with CoreValve/Evolut-R (Medtronic Inc.). The median follow-up duration was 5 years (interquartile range: 2.9 to 6; longest: 8 years). At 1, 5, and 8 years, estimated survival rates were 89.0%, 61.1%, and 56.0%, respectively, while cardiovascular mortality was 8% at the end of follow-up. Regarding valve performance, 5% of patients had early BVF and 1% had late BVF. Concerning SVD, 16 patients (6% of the total population) had moderate SVD (91% had an increase in mean gradient), with no severe SVD cases. Five patients with SVD died during follow-up. Actual analysis of the 8-year cumulative incidence of function of moderate SVD was 5.9% (2.5% to 16.2%). At multivariate analysis, the factor that emerged as an independent predictor for future SVD, was smaller bioprosthetic valve size (HR 0.58, 95% CI 0.41 to 0.82, p = 0.002). Long-term evaluation beyond 5 years after TAVI with a self-expanding bioprosthesis demonstrated low rates of cardiovascular mortality and structural valve deterioration. Valve size was an independent predictor for SVD.

Transfemoral transcatheter aortic valve replacement in the presence of a mitral prosthesis.

PURPOSE: In the current case series, we present our experience with the self-expanding CoreValve or Evolut R (Medtronic Inc.) in patients with severe symptomatic aortic valve stenosis and concomitant mitral valve prosthesis. METHODS: Twelve patients with previous mitral valve prosthesis underwent transcatheter aortic valve replacement for severe symptomatic aortic valve stenosis and/or aortic valve regurgitation. All patients underwent evaluation with an echocardiogram, computed tomography and coronary angiogram. After the index intervention and before discharge all patients underwent transthoracic echocardiography. All outcomes were defined according to the Valve Academic Research Consortium-2 criteria. RESULTS: Eleven patients underwent transcatheter aortic valve replacement for severe symptomatic aortic valve stenosis and one patient for severe aortic valve regurgitation. There was immediate improvement of patients' hemodynamic status; no cases of procedural death, stroke, myocardial infarction, or urgent cardiac surgery occurred. There was no 30-day mortality and all patients improved, with 91.6% in functional New York Heart Association class I-II. CONCLUSION: The current study demonstrates that in patients with severe aortic valve stenosis or regurgitation and mitral valve prosthesis, the implantation of a self-expanding aortic valve via the transfemoral route is safe and feasible, with maintained long-term results.

Impact of Valve Over-Sizing After Transcatheter Aortic Valve Implantation With a Self-Expanding Valve: A Multislice Computed Tomography Study.

BACKGROUND: In transcatheter aortic valve implantation (TAVI), prosthesis over-sizing prevents paravalvular leak (PVL). Strategies of over-sizing for self-expanding bioprostheses are not well established at present. METHODS: Patients with aortic valve stenosis scheduled for TAVI underwent preprocedural multislice computed tomography. Based on the degree of over-sizing, a ROC curve was drawn to define the optimal value of valve sizing for reducing PVL after TAVI. RESULTS: A total of 152 consecutive patients were included in the study (mean age, 79.95 ± 7.71 years; log EuroScore: 23.87 ± 8.93%). Based on the ROC curve, sizing of 14% was the optimal that would lead to less moderate/severe PVL (P<.01). Group 1 was defined as sizing <14% (n = 49 patients) and group 2 was defined as sizing ≥14% (n = 103 patients). During a follow-up period of 36 ± 14 months, a total of 9 patients died from group 1 vs 4 patients from group 2 (P<.01). Two of the patients who died had moderate/severe PVL and 11 had no/mild PVL (P=.27). From the population, a total of 49 patients (32%) were found to be in the "borderline" zone. Patients who received the smaller valve had lower mean left ventricular outflow tract diameter (P=.048), higher rate of calcium load (mild: 10 [32%] vs 13 [72%]; moderate: 16 [52%] vs 3 [17%]; severe: 5 [16%] vs 2 [11%]; P=.02) and lower mean of sinus of Valsalva diameter (P=.046) compared with patients who received the bigger valve. CONCLUSIONS: In patients undergoing TAVI, over-sizing the prosthesis at least 14% reduces PVL. In borderline cases, taking into consideration additional anatomical parameters may result in low rates of PVL.

The prognostic value of CHA2DS2-VASc and GRACE risk scores in patients with ACS.

OBJECTIVE: Cardiovascular diseases are the first cause of death in western societies. Therapeutic interventions in the individual patient should be guided by the so-called ischemic risk of this patient. PURPOSE: The aim of the study was to study the ischemic prognostic scores GRACE and CHA2DS2-VASc, in patients underwent angioplasty to highlight which best predicts better the ischemic risk. METHODS: Consecutives patients who underwent Percutaneous Coronary Intervention (PCI) due to Acute Coronary Disease, or elective PCI in one centre in Athens, Greece, where included in the study. The GRACE score and the CHA2DS2-VASc score were calculated. RESULTS: 667 patients participated in the study with an average age of 61 ± 11 years and were followed-up for 2 years. The GRACE score and its predicted incidence at 3 years, was compared to the CHA2DS2-VASc score. CHA2DS2-VASc score was able to show a marginally better prognosis of future ischemic events, with an AUC of 0.624 vs 0.608 of the GRACE score. CONCLUSIONS: In our study, The CHA2DS2-VASc score managed to predict, marginally better, the appearance of MACCE over GRACE, in patients with angioplasty.

Multi-slice CT (MSCT) imaging in pretrans-catheter aortic valve implantation (TAVI) screening. How to perform and how to interpret.

Aortic valve stenosis (AS) is the most common valvular heart disease among elderly. Trans-catheter aortic valve implantation (TAVI) has become an established and effective alternative therapeutical procedure for inoperable and high-risk patients with symptomatic AS. The procedural success is greatly dependent on a thorough pre-TAVI imaging screening. This requires a comprehensive and multi-modality approach, in which multi-slice computed tomography (MSCT) is the cornerstone in the selection of eligible patients, in choosing the appropriate prosthesis and size, and in mapping the safest access route for the intervention. From our experience of more than 400 TAVI procedures and many more MSCTs for screening purposes, we provide clinical and technical details on the use of MSCT pre-TAVI and brief review of the knowledge so far.

The requirement of extracorporeal circulation system for transluminal aortic valve replacement: Do we really need it in the catheterization laboratory?

Transcatheter aortic valve replacement (TAVR) is the mainstay for treating high-risk patients with aortic stenosis. As the TAVR procedures worldwide keep increasing, it is inevitable that more issues and complications will arise. Such a complication that merits attention is the conversion of TAVR into open-heart surgery and the necessity this complication creates to have an extracorporeal circulation system in the catheterization laboratory. This review contains an analysis of all major randomized trials and registries on the number and cause of TAVR procedures that ended up in open-heart surgery and presents data to challenge the prerequisite of extracorporeal circulation system in the cath laboratory. © 2015 Wiley Periodicals, Inc.

Managing the lipid profile of coronary heart disease patients.

INTRODUCTION: Lipid profile management is even more critical in patients treated for secondary prevention, since patients with established coronary heart disease are at higher risk of developing events. Current guidelines encourage lifestyle modification and patient engagement in disease prevention. However, the American College of Cardiology/American Heart Association guidelines seem to differ considerably from their predecessors, having an impact on clinical practice of lipid management. Area covered: This review article discusses and provides a summary of the current recommendations for lipid profile management in patients with coronary heart disease, with a view to present lifestyle modification and novel treatment strategies, and to indicate areas of dispute among recent guidelines. Expert commentary: Existing controversies between current guidelines concerning treatment goals and therapeutic decisions may have potential implications on the clinical management of patients. In the meantime, we eagerly wait for the results of randomized controlled trials evaluating promising, potent, safe and prolonged drugs that are in progress.

Outcomes of Same Day Pacemaker Implantation after TAVI.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is often associated with conduction disturbances, followed by permanent pacemaker (PPM) implantation. Because of the potential reversibility of these conduction disorders, controversy exists regarding the right timing of PPM implantation. TAVI is routinely performed under dual-antiplatelet and antithrombotic therapy, which poses an additional hemorrhagic risk on a same-day procedure. The aim of the present study was to evaluate the safety and effectiveness of same-day PPM implantation in patients undergoing TAVI. METHODS: Consecutive patients undergoing TAVI with Medtronic Corevalve bioprosthesis (Medtronic Inc., Minneapolis, MN, USA) in a tertiary center were divided into two study groups. Group A included patients undergoing PPM implantation the same day with TAVI, and Group B patients were implanted with a PPM later after TAVI and before hospital discharge. The two study groups were compared for all complications associated with PPM implantation. RESULTS: In total, 168 patients were included in the study. PPM was implanted in 65 patients (38.7%). In 23 patients, a PPM was implanted the same day with TAVI (Group A) and in 42 patients PPM implantation was postponed at least 1 day (Group B). Cephalic vein was the access used for the leads in the majority of cases. There was only one case of pneumothorax in Group B. There were no differences in the incidence of pocket hematomas between the study groups. CONCLUSIONS: Same-day PPM implantation after TAVI is safe and feasible. Strategies reducing pocket hematomas are essential in such patients of high hemorrhagic risk.

Therapeutic Applications of Calcium Metabolism Modulation in Heart Disease.

Cardiovascular disease is the leading cause of death worldwide and there is extensive research on the pathophysiology of all its clinical entities. Despite the big array of possible therapeutic modalities for cardiovascular disease, there is still a big necessity to develop novel treatments that will augment our strategies for tackling the burden of cardiovascular disease and decrease morbidity and mortality. A major player in both the physiology and pathophysiology of the cardiovascular system is calcium. Extracellular calcium is required in order to initiate cardiac muscle contraction and promote the calcium-induced calcium release mechanism from the sarcoplasmic reticulum. A lot of molecules and structures that in a direct or indirect way interact with calcium are being studied and there is a constant flow of new information that is emerging. In this review we focus on some of these calcium metabolism modulators representatives such as SERCA2a, RyR2, S100A1, phosholamban and calcineurin. We emphasize on their mechanism of action, their role in cardiovascular disease and potential therapeutic implications. We also focus on the effect the bisphosphonates might have in regression of the calcium deposition in the human arteries as well as the usage of novel biomarkers such as mircoRNAs in calcium metabolism modulation in heart disease.

One-year outcomes after direct transcatheter aortic valve implantation with a self-expanding bioprosthesis. A two-center international experience.

BACKGROUND: Balloon aortic valvuloplasty (BAV) is considered to be an essential part of the transcatheter aortic valve implantation (TAVI) procedure and is being performed routinely. At present there is insufficient long-term data as to the benefits of routine BAV prior to TAVI. AIM: The aim of this study was to evaluate the safety of direct TAVI and the mortality rate at 1-year in patients undergoing TAVI with or without BAV with a self-expanding bioprosthesis. METHODS: Between January 2008 and September 2013 consecutive patients undergoing TAVI with the Medtronic CoreValve in two experienced centers in Athens, Greece and in Siegburg, Germany were studied. All data were prospectively collected and retrospectively analyzed. Primary endpoint was mortality at 1 year. Procedural data and clinical data (bleeding, vascular complications and echocardiographic parameters) were analyzed. RESULTS: A total of 210 patients undergoing TAVI were evaluated (non-direct=120 patients, direct=90 patients). All-cause mortality at 30 days and at 1 year was similar in both groups (4% in non-direct versus 2% in direct, p=0.6 and 15% in non-direct versus 11% in direct, p=0.5, respectively). Device success rate was similar in both groups (77% in non-direct versus 83% in direct, p=0.2). Major vascular complications were comparable for both groups (5% in non-direct versus 3% in direct, p=0.5). The direct group had less moderate/severe paravalvular leakage than the non-direct group after the device implantation (7% versus 33%, p<0.01). CONCLUSIONS: Performing direct TAVI with the self-expanding bioprosthesis is safe and feasible showing similar mortality rates compared to patients undergoing non-direct TAVI at 30 days and at 1-year.