Coronary Sinus Reducer Implantation for the Treatment of Chronic Refractory Angina: A Single-Center Experience.

OBJECTIVES: The aim of this study was to assess the safety and efficacy of the Reducer in a real-world cohort of patients presenting with refractory angina. BACKGROUND: The coronary sinus Reducer is a novel device to aid in the management of patients with severe angina symptoms refractory to optimal medical therapy and not amenable to further revascularization. METHODS: Fifty patients with refractory angina and objective evidence of myocardial ischemia who were judged unsuitable for revascularization were treated with coronary sinus Reducer implantation at a single center between March 2015 and August 2016. Safety endpoints were procedural success and the absence of device-related adverse events. Efficacy endpoints, assessed at 4- and 12-month follow-up, were a reduction in Canadian Cardiovascular Society angina class, improvement in quality of life assessed using the Seattle Angina Questionnaire, improvement in exercise tolerance assessed using the 6-min walk test, and reduction in pharmacological antianginal therapy. RESULTS: Procedural success was achieved in all patients, with no device-related adverse effects during the procedure or at follow-up. Regarding the efficacy endpoint, 40 patients (80%) had at least 1 reduction in Canadian Cardiovascular Society class, and 20 patients (40%) had at least 2 class reductions, with a mean class reduction to 1.67 ± 0.83 vs. 2.98 ± 0.52 (p < 0.001) at 4-month follow-up. All Seattle Angina Questionnaire items improved significantly (p < 0.001 for all). A significant increment in 6-min walk distance to 388.6 ± 119.7 m vs. 287.0 ± 138.9 m (p = 0.004) was observed. Sixteen patients (32%) and 3 patients (6%) demonstrated reductions of at least 1 or 2 antianginal drugs, respectively. The benefit of Reducer implantation observed at 4-month follow-up was maintained at 1 year. CONCLUSIONS: In this real-world, single-center experience, implantation of the coronary sinus Reducer appeared safe and was associated with reduction in anginal symptoms and improvement in quality of life in patients with refractory angina who were not candidates for further revascularization.

The Influence of Dietary Components on Early Signs of Atherosclerosis in Apparently Healthy Young-adult Males: An Observational Study of 615 Subjects.

BACKGROUND: The literature shows that a healthy diet, rich in fruits and vegetables, has positive effects on overall cardiovascular risk, protecting against atherosclerosis. DESIGN: A cross sectional study in a population of apparently healthy young-adult men with the aim of investigating dietary determinants of early atherosclerosis, assessed by measuring carotid intima-media thickness (cIMT) and flow-mediated dilation (FMD) of the brachial artery. METHODS: 615 males (mean age ± SD: 40.8±9.8 years) without overt atherosclerosis were evaluated. Dietary intake was quantified by the European Prospective Investigation into Cancer and Nutrition (EPIC) questionnaire. Intake of antioxidants was expressed in relation to total caloric intake. RESULTS: Neither absolute, recommended daily allowance or weight-related values of nutritional intake variables were associated with cIMT. Vitamin E to total calories intake (odds ratio, OR=0.08, 95%CI=0.03-0.89) was inversely associated with impaired FMD. Non-nutritional correlates of FMD <10% were: age (OR=1.02, 95%CI=1.0-1.05) and waist circumference (OR=1.03, 95%CI=1.0-1.06), and those of cIMT >0.8 mm were age (OR=1.10, 95%CI=1.05-1.15), pack-years (OR=1.02, 95%CI=1.0-1.04), C-reactive protein (OR=1.17, 95%CI=1.04-1.33) and total cholesterol (OR=1.01, 95%CI=1.0-1.02). CONCLUSION: Differences in the factors correlating with cIMT >0.8 mm and FMD <10% might have implications for cardiovascular risk reduction. A lower antioxidant to caloric intake ratio might be a risk factor for impaired FMD.

Left atrial appendage closure: A single center experience and comparison of two contemporary devices.

OBJECTIVES: To compare indications and clinical outcomes of two contemporary left atrial appendage (LAA) percutaneous closure systems in a "real-world" population. BACKGROUND: Percutaneous LAA occlusion is an emerging therapeutic option for stroke prevention in atrial fibrillation. Some questions however remain unanswered, such as the applicability of results of randomized trials to current clinical practice. Moreover, currently available devices have never been directly compared. METHODS: We retrospectively analyzed consecutive patients who underwent LAA closure at San Raffaele Hospital, Milan, Italy between 2009 and 2015. Clinical indications and device selection were left to operators' decision; routine clinical and transesophageal echocardiography (TEE) follow-up was performed. RESULTS: One-hundred and sixty-five patients were included in the study, of which 99 were treated with the Amplatzer Cardiac Plug (ACP) and 66 with the Watchman system. During the follow-up period (median 15 months, interquartile range 6-26 months) five patients died. The incidence of ischemic events was low, with one patient suffering a transient ischemic attack and no episodes recorded of definitive strokes. Twenty-six leaks ≥1 mm were detected (23%); leaks were less common with the ACP and with periprocedural three-dimensional TEE evaluation, but were not found to correlate with clinical events. Clinical outcomes were comparable between the two devices. CONCLUSIONS: Our data show excellent safety and efficacy of LAA closure, irrespectively of the device utilized, in a population at high ischemic and hemorrhagic risk. The use of ACP and 3D-TEE minimized the incidence of residual leaks; however, the clinical relevance of small peri-device flow warrants further investigation. © 2016 Wiley Periodicals, Inc.

The coronary sinus reducer: clinical evidence and technical aspects.

INTRODUCTION: Chronic refractory angina is often a disabling condition, predominantly due to severe obstructive coronary artery disease, that is inadequately controlled by optimal medical therapy and not amenable to further percutaneous or surgical revascularization. mortality rates associated with this condition are relatively low in clinically stable patients. however, it is associated with a high hospitalization rate and a reduction in both exercise capacity and quality of life. due to the paucity of available treatment options, there is an unmet need for new therapies for these patients and for a reduction in the associated economic healthcare burden. Areas covered: This review is focusing on the clinical evidence and technical aspects of this new therapeutic modality in refractory angina patients unsuitable for revascularization. Expert commentary: The Coronary Sinus Reducer (Neovasc Inc. Richmond B.C., Canada) is a new percutaneous device designed to achieve a controlled narrowing of the coronary sinus that may alleviate myocardial ischemia, possibly by redistributing blood from the less ischemic sub-epicardium to the more ischemic sub-endocardium, or by neoangiogenesis. Recently, a randomized, double-blind, multi-center clinical trial demonstrated a benefit in improving symptoms in 104 refractory angina patients, when compared to placebo.

[Coronary Sinus Reducer implantation: a new treatment for chronic refractory angina]. / Impianto del dispositivo Reducer in seno coronarico: un nuovo trattamento per l'angina refrattaria.

Refractory angina is a chronic condition characterized by the presence of disabling symptoms due to severe obstructive coronary artery disease not improved by either optimal medical therapy and/or percutaneous or surgical revascularization. Mortality rates associated with this condition are quite low in clinically stable patients on optimal medical therapy. However, rehospitalization rates are high. In this subgroup of patients there is thus a clinical need for new therapies targeting an improvement of symptoms but taking into account the potential impact in terms of healthcare and costs. A considerable number of innovative therapeutic modalities for the treatment of refractory angina have been investigated over the years. However, none of them has become a standard of care. Devices implanted in coronary sinus are a possible therapeutic option in these patients that may alleviate myocardial ischemia by forcing redistribution of coronary blood flow from less ischemic subepicardium to the more ischemic subendocardium, potentially relieving symptoms of ischemia. The coronary sinus Reducer (Neovasc Inc., Richmond B.C., Canada) is a percutaneous implantable device designed to achieve controlled narrowing of the coronary sinus and to increase its upstream pressure. Coronary sinus Reducer implantation was associated with improvement in symptoms and reduction of myocardial ischemia in pre-clinical and clinical studies. Recently, a randomized, double-blind, multicenter clinical trial demonstrated, in 104 patients with refractory angina, its benefit in improving symptoms, when compared to placebo.

Impact of post-procedural hyperglycemia on acute kidney injury after transcatheter aortic valve implantation.

BACKGROUND: Post-operative hyperglycemia, in individuals with and without diabetes, has been identified as a predictor of acute kidney injury (AKI) in patients following cardiac surgery. Whether or not this is also true for patients undergoing transcatheter aortic valve implantation (TAVI) is unknown. OBJECTIVES: To evaluate whether post-procedural glucose levels are associated with AKI after TAVI. METHODS AND RESULTS: A total of 422 consecutive patients undergoing transfemoral TAVI were included in the analysis. For each patient, plasma glucose levels were assessed at hospital admission, 4h after the procedure and daily during hospitalization. Post-procedural hyperglycemia was defined as 2 consecutive blood glucose readings ≥150mg/dL in the 72-hour period following TAVI. AKI was defined according to the VARC consensus report regarding standardized endpoint definitions. Overall, 137 (32.5%) patients developed post-procedural hyperglycemia and 138 (33%) patients developed AKI. Hyperglycemia was associated with a 2-fold higher incidence of AKI than in patients without hyperglycemia (48% vs. 25%, p<0.001). In-hospital mortality was higher in patients with hyperglycemia than in those without hyperglycemia (9.6% vs. 1.8%, p<0.001). In-hospital mortality rate was also higher in patients who developed AKI (12.7% vs. 2.7%, p<0.001). Patients with acute hyperglycemia that developed AKI had the highest in-hospital and long-term mortality rate (15% and 38%). Post-procedural hyperglycemia was an independent predictor of AKI. CONCLUSIONS: Post-procedural hyperglycemia is associated with a higher incidence of AKI and mortality after TAVI. Randomized controlled trials are needed to determine whether meticulous post-procedural glycemic control following TAVI impacts upon clinical outcomes.

Excimer laser facilitated coronary angioplasty of a heavy calcified lesion treated with bioresorbable scaffolds.

: Excimer coronary laser atherectomy (ECLA) has been shown to be both well tolerated and effective for plaque modification. Its technology is based on ultraviolet energy and is capable of disintegrating atheroma, without burning or grossly fragmenting it. ELCA has proven effective in the percutaneous treatment of a variety of complex lesions. Here we present a case of multiple heavy calcified lesions successfully prepared with ELCA and finally treated with the implantation of multiple bioresorbable scaffolds.

Successful implantation of a second-generation aortic valve in severe aortic regurgitation secondary to a traumatic cusp lesion.

A 67-year-old man with a dilated cardiomyopathy and severe aortic regurgitation (AR) secondary to a traumatic cusp lesion was referred to our institution because of progressive worsening of dyspnea. After formal discussion in the heart team, the patient was scheduled for TAVI (transcatheter aortic valve implantation). The pre procedural computed tomography scan revealed a minimum amount of calcium on the aortic valve and low position of coronary ostia. The TAVI procedure was performed with the implantation of a fully retrievable and repositionable aortic valve prosthesis (Direct Flow 29 mm, Direct Flow Medical, Santa Rosa, California) with an excellent result and no paravalvular leak. The TAVI devices designed for the treatment of calcific aortic stenosis have numerous limitations for the treatment of pure AR such as the risk of residual AR, the lack of repositionability and retrievability, and the need for valve- in-valve implantation. We believe that treatment of selected cases of pure AR with the Direct Flow valve is feasible and takes advantage of the retrievability of the prosthesis.

Sudden cardiac death in the young: the bogeyman.

Sudden cardiac death in the young is a relatively uncommon but marked event usually related to congenital diseases or anomalies. Despite the prevalence of each condition being variable, most common causes include primary myocardial diseases and arrhythmic disorder, frequently with inheritance pattern. Sudden cardiac death is usually preceded by symptoms, thus making personal and family history fundamental for its prevention. Nevertheless, in more than 50% of cases, sudden cardiac death is the first manifestation of the disease. In this review, we describe the different causes of sudden cardiac death, their incidence, and currently used preventive strategies.

Contrast-induced nephropathy in percutaneous coronary interventions: pathogenesis, risk factors, outcome, prevention and treatment.

Contrast-induced nephropathy (CIN) is a well-known adverse event of therapeutic and diagnostic procedures requiring the administration of contrast medium (CM). The lack of a universal CIN definition and glomerular filtration rate markers that vary have resulted in a variety of reported incidences. The development of CIN is associated with an increase in the length of hospital stay and the risk of death. Preexisting renal dysfunction, age, diabetes, congestive heart failure and the volume of CM administered are all associated with a risk for developing CIN. The literature suggests the use of low-osmolarity CM and supports volume supplementation before administration. Moreover, other strategies to avoid CIN, including treatment with N-acetylcysteine and sodium bicarbonate have variable levels of evidence. This review examines the main components of the pathogenesis and risk factors of CIN and possible preventive measures and therapies.

Sodium bicarbonate plus N-acetylcysteine to prevent contrast-induced nephropathy in primary and rescue percutaneous coronary interventions: the BINARIO (BIcarbonato e N-Acetil-cisteina nell'infaRto mIocardico acutO) study.

AIMS: Contrast-induced nephropathy (CIN) is a frequent and potentially harmful complication of percutaneous coronary interventions (PCI), especially in the setting of ST-elevation myocardial infarction (STEMI). We tested the efficacy of a sodium bicarbonate (SB)-based hydration in urgent PCI for STEMI. METHODS AND RESULTS: From June 2009 to September 2010, 262 consecutive STEMI patients undergoing urgent PCI were prospectively enrolled and treated by SB-based hydration (154 mEq/L at 3 ml Kg-1 for one hour followed by 1 ml Kg-1 for six hours) (group A). As controls, 262 consecutive STEMI patients receiving 0.9% saline hydration (1 ml Kg-1 for 24 hours) before June 2009 were retrospectively enrolled (group B). Both groups received high-dose N-acetylcysteine (NAC). The primary endpoint was the composite of in-hospital death, need for dialysis and CIN (≥25% increase in serum creatinine at 48 hours). The two groups were comparable for baseline clinical and procedural characteristics, for Mehran risk score and baseline estimated glomerular filtration rate. The primary combined endpoint was significantly reduced in group A as compared to group B (9.2 vs. 18.7%, p=0.023) with a number needed to treat (NNT) of 11. Specifically, a significant reduction of both in-hospital death (2.3 vs. 6.1%, p=0.049, NNT 27) and CIN (8.0 vs. 14.1%, p=0.03, NNT 17) was observed, with no difference in the need for dialysis. CONCLUSIONS: Our data indicate that hydration with sodium bicarbonate in addition to high-dose NAC in the setting of urgent PCI for STEMI is associated with a net clinical benefit.

Maximal hyperemia in the assessment of fractional flow reserve: intracoronary adenosine versus intracoronary sodium nitroprusside versus intravenous adenosine: the NASCI (Nitroprussiato versus Adenosina nelle Stenosi Coronariche Intermedie) study.

OBJECTIVES: This study sought to compare increasing doses of intracoronary (i.c.) adenosine or i.c. sodium nitroprusside versus intravenous (i.v.) adenosine for fractional flow reserve (FFR) assessment. BACKGROUND: Maximal hyperemia is the critical prerequisite for FFR assessment. Despite i.v. adenosine currently representing the recommended approach, i.c. administration of adenosine or other coronary vasodilators constitutes a valuable alternative in everyday practice. However, it is surprisingly unclear which i.c. strategy allows the achievement of FFR values comparable to i.v. adenosine. METHODS: Fifty intermediate coronary stenoses (n = 45) undergoing FFR measurement were prospectively and consecutively enrolled. Hyperemia was sequentially induced by incremental boli of i.c. adenosine (ADN) (60 µg ADN60, 300 µg ADN300, 600 µg ADN600), by i.c. sodium nitroprusside (NTP) (0.6 µg/kg bolus) and by i.v. adenosine infusion (IVADN) (140 µg/kg/min). FFR values, symptoms, and development of atrioventricular block were recorded. RESULTS: Incremental doses of i.c. adenosine and NTP were well tolerated and associated with fewer symptoms than IVADN. Intracoronary adenosine doses (0.881 ± 0.067, 0.871 ± 0.068, and 0.868 ± 0.070 with ADN60, ADN300, and ADN600, respectively) and NTP (0.892 ± 0.072) induced a significant decrease of FFR compared with baseline levels (p < 0.001). Notably, ADN600 only was associated with FFR values similar to IVADN (0.867 ± 0.072, p = 0.28). Among the 10 patients with FFR values ≤0.80 with IVADN, 5 were correctly identified also by ADN60, 6 by ADN300, 7 by ADN600, and 6 by NTP. CONCLUSIONS: Intracoronary adenosine, at doses higher than currently suggested, allows obtaining FFR values similar to i.v. adenosine. Intravenous adenosine, which remains the gold standard, might thus be reserved for those lesions with equivocal FFR values after high (up to 600 µg) i.c. adenosine doses.

Plasticity of prospective memory through a familiarization intervention in old adults.

Younger adults consistently outperform older adults in laboratory prospective memory tasks. This study examines the effectiveness of an intervention that familiarizes older adults with the sequence of ongoing events to compensate their reduced prospective memory performance. We compared performance and electrophysiological measures of an intervention group (N = 20, 69-83 years) receiving a familiarization intervention to an individually matched control group (N = 20). As ongoing activity a 2-back working memory task was administered. Neural correlates were studied using event related potentials (ERPs) and source localization (standardized low-resolution brain electromagnetic tomography). Behavioural data showed faster reaction times in correct prospective trials and fewer prospective false alarms in the familiarization intervention group. ERP analyses displayed differential patterns for the two groups and source localization measures distinctively presented group differences in prospective memory trials with the control group recruiting more resources for a successful prospective memory performance. Together our data support the hypothesis that the familiarity with the sequence of ongoing events increases prospective memory performance and that this might be based on a higher efficiency of attentional monitoring resources and evaluation processes in the intervention group.

[Focal myocarditis mimicking ST-elevation myocardial infarction in a patient with Helicobacter pylori infection: role of magnetic resonance with late gadolinium enhancement]. / Miocardite simulante un infarto miocardico acuto con sopraslivellamento del tratto ST in paziente con infezione da Helicobacter pylori: ruolo della risonanza magnetica con late gadolinium enhancement.

Myocarditis is an emerging disease. We have investigated a case of focal myocarditis with ventricular thrombus in a patient with Helicobacter pylori infection who came to our attention for the persistence of chest pain one week after previous discharge. The patient was before and otherwise misunderstood as myocardial infarction and recognized in our Centre as myocarditis by magnetic resonance. Diagnostic iter was focused on understanding the pathogenesis of the previous reported cardiac event as well as a link with the persistence of chest pain finally found related to Helicobacter pylori infection. We briefly discuss about role and some caveats of magnetic resonance with late gadolinium enhancement as new diagnostic approach of myocarditis, compared to myocardial biopsy.