Valve Hemodynamics by Valve Size and 1-Year Survival Following Implantation of the Portico Valve in the Multicenter CONFIDENCE Registry.

Background: The CONtrolled delivery For ImproveD outcomEs with cliNiCal Evidence registry was initiated to characterize the clinical safety and device performance from experienced transcatheter aortic valve implantation (TAVI) centers in Europe and Australia that use the Portico valve to treat patients with severe aortic stenosis. We herein report for the first time the valve performance at 30-day across all implanted valve sizes and the 1-year survival from this registry. Methods: This was a prospective, multicenter, single-arm observational clinical investigation of patients clinically indicated for implantation of a Portico valve in experienced TAVI centers. Patients were treated with a commercially available valve (size 23, 25, 27, or 29 mm) using either the first-generation delivery system (DS) (n = 501) or the second-generation (FlexNav) DS (n = 500). Adverse events were adjudicated by an independent clinical events committee according to Valve Academic Research Consortium-2 criteria. Echocardiographic outcomes were assessed at 30 days by an independent core laboratory, and a survival check was performed at 1 year. Results: We enrolled 1001 patients (82.0 years, 62.5% female, 63.7% New York Heart Association functional class III/IV at baseline) from 27 clinical sites in 8 countries across Europe and one site in Australia. Implantation of a single valve was successful in 97.5% of subjects. Valve hemodynamics at 30 days were substantially improved relative to baseline, with large aortic valve areas and low mean gradients across all implanted valve sizes (aortic valve areas were 1.7 ± 0.4, 1.7 ± 0.5, 1.8 ± 0.5, and 2.0 ± 0.5 cm2, and mean gradients were 7.0 ± 2.7, 7.5 ± 4.7, 7.3 ± 3.3, and 6.4 ± 3.3 mmHg for 23, 25, 27, and 29 mm valve sizes, respectively). Across all implanted valve sizes, most patients (77.1%) had no patient-prosthesis mismatch. Death from any cause within 1 year occurred in 13.7% of the patients in the first-generation DS group as compared with 11.0% in the second-generation DS group (p = 0.2). Conclusions: The Portico valve demonstrated excellent hemodynamic performance across all valve sizes in a large cohort of subjects implanted in experienced TAVI centers. One-year survival rates were favorable when using both the first-generation and second-generation (FlexNav) DSs in this high-risk cohort. ClinicalTrialsgov Identifier: NCT03752866.

Risk stratification using growth differentiation factor 15 in patients undergoing transcatheter aortic valve implantation.

AIMS: Growth differentiation factor 15 (GDF15) shows potential predictive value in various cardiac conditions. We investigated relationships between GDF15 and clinical or procedural outcomes in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) in order to propose clinically useful predictive risk stratification model. METHODS: This prospective single-center registry enrolled 88 consecutive patients with severe symptomatic aortic stenosis treated with TAVI. Clinical parameters were collected and biomarkers including GDF-15 were measured within 24 h before TAVI. All relevant clinical outcomes according to the Valve Academic Research Consortium-2 were collected over the follow-up period. RESULTS: The cohort included 52.3% of females. The mean age of study participants was 81 years; the mean Society of Thoracic Surgeons (STS) score and logistic EuroSCORE were 3.6% and 15.4%, respectively. The mortality over the entire follow-up period was 10.2%; no death was observed within the first 30 days following TAVI. Univariate analysis showed significant associations between GDF15 and mortality (P=0.0006), bleeding (P=0.0416) and acute kidney injury (P=0.0399). A standard multivariate logistic regression model showed GDF-15 as the only significant predictor of mortality (P=0.003); the odds ratio corresponding to an increase in GDF15 of 1000 pg/mL was 1.22. However, incremental predictive value was not observed when the STS score was combined with GDF15 in this predictive model. CONCLUSIONS: Based on our observations, preprocedural elevated GDF15 levels are associated with increased mortality and demonstrate their additional value in predicting adverse clinical outcomes in a TAVI population.

Complete revascularization of multivessel coronary artery disease in patients with ST elevation acute coronary syndrome - for whom and when? A comprehensive review.

Atherosclerosis is the most common cause of coronary steno-occlusive disease and acute myocardial infarction is the leading cause of death in industrialized countries. In patients with acute ST elevation myocardial infarction (STEMI), there is unquestionable evidence that primary percutaneous coronary intervention providing recanalization of the infarct related artery (IRA) is the preferred reperfusion strategy. Nevertheless, up to 50% of patients with STEMI have multivessel coronary artery disease defined as at least 50% stenosis exclusive of IRA. There is conflicting data regarding the optimal treatment strategy and timing in such patients. Currently, it is assumed that stable patients might benefit from complete revascularization particularly in reducing the need for future unplanned procedures but only culprit lesion should be treated during index procedure in unstable patients. In this article, we provide a comprehensive overview of this important and currently highly debated topic.

Determination of the prevalence and predictors of ventricular thrombus with assessment of the risk of systemic embolization to the CNS in patients after acute myocardial infarction using magnetic resonance imaging, echocardiography and cardiac markers - a prospective, unicentric, observational study.

BACKGROUND: Left ventricular thrombus (LVT) formation is one of the well-known and serious complications of acute myocardial infarction (AMI) due to the risk of systemic arterial embolization (SE). To diagnose LVT, echocardiography (TTE) is used. Late gadolinium-enhanced cardiovascular magnetic resonance (DE-CMR) is the gold standard for diagnosing LVT. OBJECTIVES: The aim of this observational study was to determine the role of transthoracic echocardiography and cardiac markers in predicting the occurrence of LVT compared with a reference cardiac imaging (DE-CMR) and to determine the risk of systemic embolization to the CNS using brain MRA. METHODS: Seventy patients after MI managed by percutaneous coronary intervention (localization: 92.9% anterior wall, 7% other; median age 58.7 years) were initially examined by transthoracic echocardiography (TTE, n=69) with a focus on LVT detection. Patients were then referred for DE-CMR (n=55). Laboratory determination of cardiac markers (Troponin T and NTproBNP) was carried out in all. Brain MRA was performed 1 year apart (n=51). RESULTS: The prevalence of LVT detected by echocardiography: (n=11/69, i.e. 15.9%); by DE-CMR: (n=9/55, i.e. 16.7%). Statistically significant parameters to predict the occurrence of LVT after AMI (cut off value): (a) detected by echocardiography: anamnestic data - delay (≥ 5 hours), echocardiographic parameters - left atrial volume index (LAVI≥ 32 mL/m2), LV EF Simpson biplane and estimated (≤ 42%), tissue Doppler determination of septal A wave velocity (≤ 7.5cm/s); (b) detected by DE-CMR: anamnestic data - delay (≥ 13 hours), DE-CMR parameters - left ventricular end-diastolic diameter (≥ 54mm). The value of cardiac markers (Troponin T and NTproBNP in ng/L) in LVT detected by echocardiography did not reach statistical significance. In LVT detected by DE-CMR, NTproBNP was statistically significantly increased at 1 month after AMI onset (no optimal cut-off value could be determined). There was no statistically significant association between the LVT detection (both modalities) and the occurrence of clinically manifest and silent cardioembolic events. CONCLUSION: Our study confirmed a relatively high prevalence of LVT in the high-risk group of patients with anterior wall STEMI. Due to the low prevalence of thromboembolic complications, no significant association between the LVT detection and the occurrence of a cardioembolic event was demonstrated.

Comparison of angiographic estimation and invasive hemodynamic measurement of the significance of non-infarct-related residual stenoses in ST-elevation myocardial infarction patients.

Introduction: Up to 50% of patients with ST elevation myocardial infarction (STEMI) have ≥ 50% stenosis in a major non-infarct-related artery. Several studies have evaluated the prognostic value of the completion of revascularization with overall inconclusive results. Selection of the stenoses was based on the angiographic evaluation, invasive hemodynamic measurement or the combined approach. It is unknown whether such a selection provides correlation of comparable patient groups. Material and methods: We enrolled 51 patients (62.7 ±10.2 years) with acute STEMI and at least one residual (50-90%) stenosis in a non-infarct-related major coronary artery (excluding left main coronary artery). Overall 65 stenoses (67.9 ±10.7%) were evaluated angiographically following primary percutaneous coronary intervention and the hemodynamic significance was estimated with respect to the stenosis severity, caliber of the arterial segment, localization of the stenosis (proximity) as well as the estimated size of the supplied vascular territory. During subsequent hospitalization, invasive measurement of the hemodynamic significance using fractional flow reserve (FFR) was performed to guide the final revascularization strategy (FFR value of ≤ 0.80 considered significant). Results: Based on angiographic evaluation, a total of 44 stenoses would be recommended for treatment, whereas only 31 stenoses were revascularized based on FFR measurement. Moreover, visual evaluation and hemodynamic measurement were discrepant in 27 of 65 (41.5%) stenoses. Conclusions: We observed a weak correlation between visual angiographic evaluation and invasive hemodynamic measurement. More stents would be implanted based on angiographic evaluation compared to FFR measurement.

Procedural Safety and Device Performance of the Portico™ Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry.

A total of 1001 subjects (82.0 years, 62.5% female, 63.7% NYHA III/IV at baseline) with severe aortic stenosis at high surgical risk were enrolled in the prospective CONFIDENCE registry and treated with a Portico™ transcatheter heart valve (THV) using either a first-generation delivery system (DS) or the FlexNav™ DS. The objective of this registry is to characterize the procedural safety and device performance of the Portico™ THV at 30 days. The study collected 'standard-of-care' clinical and device performance data, with adverse events adjudicated by an independent clinical event committee according to the Valve Academic Research Consortium-2 criteria. The implantation of a single Portico™ THV was successful in 97.5% of subjects. The 30-day all-cause mortality, cardiovascular mortality, and disabling stroke rates were 2.6%, 2.1%, and 1.8%, respectively. A new pacemaker was implanted in 19.0% of subjects at 30 days. At 30 days, the effective orifice area and mean gradient values were 1.82 cm2 and 7.1 mmHg, respectively. The 30-day rate of moderate paravalvular leak (PVL) was 2.1%, with no occurrence of severe PVL. The Portico™ THV demonstrated improved hemodynamic performance and low rates of safety events at 30 days in a large cohort of subjects implanted with the Portico™ THV with either the first-generation DS or FlexNav™ DS.

Interventional prevention of paradoxical embolism as the gold standard: End of discussion?

Paradoxical embolism is one of the predominant causes of cryptogenic stroke and interventional secondary prevention, i.e., closure of the patent foramen ovale (PFO), is a much discussed issue. This review aims to provide a complex perspective on this topic, aggregates and comments on the available data and current guidelines. Several large trials were performed, some of which proved the superiority of PFO closure over pharmacotherapy while others have not. Studies detecting significant superiority of intervention worked with disproportionately high representation of large shunts compared to the general population. Other controversies also remain, such as the lack of comparison of the effect of modern anticoagulant/antiplatelet treatment to PFO closure or the risk of developing unwanted side effects after intervention, and these are discussed in detail. PFO closure is a suitable method for secondary prevention of paradoxical embolism and, therefore, cryptogenic stroke. However, this is only true for carefully selected patient populations and such selection is of the utmost importance in deciding on interventional or conservative treatment.

Radial artery pseudoaneurysm as a rare very late complication of transradial cardiac catheterization.

AIMS: Here, we report a case of very late (70+ days) development of pseudoaneurysm on the site of sheath insertion in a 60- year old woman. METHODS: The patient underwent cardiac catheterization using transradial approach. RESULTS: Despite the transradial approach, which is generally considered as a suitable prevention of this problem, and despite absence of any periprocedural complications, the patient developed a pseudoaneurysm after more than 70 days from the procedure. CONCLUSIONS: In some cases, a pseudoaneurysm may develop extremely late after cardiac catheterization. Such an extremely late development of pseudoaneurysm has not been described in literature so far.

Acute myocardial infarction, intraventricular thrombus and risk of systemic embolism.

The development of left ventricular thrombus (LVT) is a well-known and serious complication of acute myocardial infarction (AMI) due to the risk of systemic arterial embolism (SE), which is variable in its clinical picture and has potentially serious consequences depending on the extent of target organ damage. SE results in an increase in mortality and morbidity in these patients. LVT is one of the main causes of the development of ischaemic cardio-embolic cardiovascular events (CVE) after MI and the determination of the source of cardiac embolus is crucial for the initiation of adequate anticoagulant therapy in secondary prevention. Echocardiography holds an irreplaceable place in the diagnosis of LVT, contrast enhancement provides higher sensitivity. The gold standard for LVT diagnosis is cardiac magnetic resonance imaging, but it is not suitable as a basic screening test. In patients with already diagnosed LVT, it is necessary to adjust antithrombotic therapy by starting warfarin anticoagulation for at least 6 months with the need for echocardiographic follow-up to detect thrombotic residues. The effect of prophylactic administration of warfarin in high-risk patients after anterior AMI does not outweigh the risk of severe bleeding complications and does not result in a decrease in mortality and morbidity. At the present time, there is not enough evidence to use direct oral anticoagulants in this indication.

Incidence, treatment strategies and outcomes of acute coronary syndrome with and without ongoing myocardial ischaemia: results from the CZECH-3 registry.

BACKGROUND: Patients with acute coronary syndrome with signs of ongoing myocardial ischaemia at first medical contact should be indicated for immediate invasive treatment. AIM: To assess the incidence, treatment strategies and outcomes of acute coronary syndrome in a large unselected cohort of patients with respect to the signs of ongoing myocardial ischaemia. METHODS: The CZECH-3 registry included 1754 consecutive patients admitted for suspected acute coronary syndrome to 43 hospitals during a 2-month period in the autumn of 2015. Acute coronary syndrome with ongoing myocardial ischaemia was defined by the presence of persistent/recurrent chest pain/dyspnoea and at least one of the following: persistent ST-segment elevation or depression, bundle branch block, haemodynamic or electric instability due to suspected ischaemia. Major adverse cardiac events (death, reinfarction, stroke, unexpected revascularisation, stent thrombosis) and severe bleeding according to Bleeding Academic Research Consortium criteria were evaluated at 30 days. RESULTS: Acute coronary syndrome was ruled out during the hospital stay in 434 (24.7%) patients. Out of 1280 patients with confirmed acute coronary syndrome, 732 (57%) had clinical signs of ongoing myocardial ischaemia at first medical contact. Coronary angiography was performed in 94.7% of patients with confirmed acute coronary syndrome with ongoing myocardial ischaemia and 89% of patients with confirmed acute coronary syndrome without ongoing myocardial ischaemia (P<0.001). The major adverse cardiac event rate was 9.8% for patients with confirmed acute coronary syndrome with ongoing myocardial ischaemia and 5.5% for patients without ongoing myocardial ischaemia (P=0.005), the 30-day severe bleeding rate was 1.6% and 1.5% (P=1.0). Patients with ongoing myocardial ischaemia admitted to regional hospitals had higher major adverse cardiac event rates compared with patients admitted directly to cardiocentres with percutaneous coronary intervention capability (13.3% vs. 8.2%, P=0.034). CONCLUSIONS: Ongoing myocardial ischaemia was present in more than half of patients hospitalised with acute coronary syndrome. These very high-risk patients may benefit from direct admission to percutaneous coronary intervention-capable centres.

Vulnerable atherosclerotic plaque - a review of current concepts and advanced imaging.

Atherosclerosis is the most common cause of both carotid and coronary steno-occlusive disease. Rupture of an atherosclerotic plaque may lead to the formation of an overlying thrombosis resulting in complete arterial occlusion or downstream embolism. Clinically, this may manifest as a stroke or acute myocardial infarction, the overall leading causes of mortality and disability in developed countries. In this article, we summarize current concepts of the development of vulnerable plaque and provide an overview of commonly used imaging methods that may suggest/indicate atherosclerotic plaque vulnerability.

HACEK-induced endocarditis.

A 61-year-old patient with diabetes had a bio-prosthetic aortic valve replacement 3 years before admission. He complained of lethargy, night sweats, decreased appetite and erratic blood glucose with no weight loss. He had splinter haemorrhage and a systolic ejection murmur at the aortic area. Chest and abdominal examination revealed no abnormality. The erythrocyte sedimentation rate and C reactive protein were raised. He had several sets of blood cultures and he was started on empirical vancomycin, rifampicin and gentamicin. Transthoracic echocardiography showed vegetation on the base of the anterior mitral leaflet, which was confirmed by a trans-oesophageal echocardiography. Blood culture was positive for Haemophilus aphrophilus, and he was started on ceftriaxone for 6 weeks instead of vancomycin and rifampicin and continued gentamicin for 2 weeks. Follow-up echocardiography showed no evidence of vegetations. The patient recovered completely and he was discharged home.

The impact and safety of preoperative oral or intravenous carbohydrate administration versus fasting in colorectal surgery--a randomized controlled trial.

BACKGROUND AND AIMS: Increasing evidence suggests that preoperative fasting, as was the clinical practice for many decades, might be associated with untoward consequences and that a standardized preoperative intake of nutrients might be advantageous; this is a component of the enhanced recovery after surgery (ERAS) concept. Thus, in a randomized controlled trial we compared preoperative fasting with preoperative preparation with either oral or intravenous intake of carbohydrates, minerals and water. Biochemical, psychosomatic, echocardiographic and muscle-power parameters were assessed in surgical patients with colorectal diseases during the short-term perioperative period. We also assessed the safety of peroral intake shortly before surgery. METHODS: A total of 221 elective colorectal surgery patients in this bicentric, randomized, prospective and blinded clinical trial were divided into three groups: A - patients fasting from midnight (control group); B - patients supported preoperatively by glucose, magnesium and potassium administered intravenously; C - patients supported preoperatively by oral consumption of a specifically composed solution (potion). RESULTS: The general perioperative clinical status of patients in groups C and B was significantly better than those in group A. Psychosomatic conditions postoperatively were found to be best in group C (P < 0.029). The rise in the index of insulin resistance (QUICKI) from the preoperative to the postoperative state was significant in group A (P < 0.05). The systolic and diastolic function of the left ventricle improved postoperatively in group C vs. group A (P < 0.04), and the ejection fraction was also significantly higher postoperatively in group C vs. group A (P < 0.03). The gastric residual volume was 5 ml and the pH of stomach juice was 3.5-5 in all groups without statistically significant difference. No difference was found in the length of hospital stay or the rate of complications. CONCLUSIONS: Preoperative fasting does not confer any benefit or advantage for surgical patients. In contrast, consumption of an appropriate potion composed of water, minerals and carbohydrates offers some protection against surgical trauma in terms of metabolic status, cardiac function and psychosomatic status. Peroral intake shortly before surgery did not increase gastric residual volume and was not associated with any risk.

Acute severe mitral regurgitation with cardiogenic shock caused by two-step complete anterior papillary muscle rupture during acute myocardial infarction.

BACKGROUND: Rupture of a papillary muscle is an infrequent but often fatal mechanical complication of acute myocardial infarction. AIM: The aim of this paper is to present a case report of a 65-year old women with acute severe mitral regurgitation with cardiogenic shock caused by two-step complete anterior papillary muscle rupture during acute myocardial infarction. The transthoracic echocardiography was obtained at the bedside and showed a posterior mitral valve prolapse with a severe mitral regurgitation. During this examination the patient developed acute pulmonary oedema and a consequent cardiogenic shock. Transthoracic echocardiography was then reevaluated and completed. New findings of bi-leaflet mitral flail and progression of massive mitral regurgitation were documented. The complete rupture of a papilary muscle was then considered as a cause of an acute clinical deterioration. Intraoperative findings showed a complete transection of both heads of anterolateral and necrotic regions of basis of posteromedial papillary muscle. CONCLUSIONS: This case confirms the importance of immediate echocardiography in confirming a diagnosis of acute mechanical complications of acute coronary syndromes and this examination is important for the management of a hemodynamically unstable patient. Echocardiography should be done immediately on any patient in whom the diagnosis of mechanical complication of acute coronary syndromes is suspected.