The effect of increased fruit and vegetable consumption on blood pressure and lipids: a pooled analysis of six randomised controlled fruit and vegetable intervention trials.

BACKGROUND: Increasing fruit and vegetable (FV) consumption is associated with reduced cardiovascular disease risk in observational studies but with little evidence from randomised controlled trials (RCTs). The impact of concurrent pharmacological therapy is unknown. OBJECTIVE: To pool data from six RCTs to examine the effect of increasing FV intake on blood pressure (BP) and lipid profile, also exploring whether effects differed by medication use. DESIGN: Across trials, dietary intake was assessed by diet diaries or histories, lipids by routine biochemical methods and BP by automated monitors. Linear regression provided an estimate of the change in lipid profile or BP associated with a one portion increase in self-reported daily FV intake, with interaction terms fitted for medication use. RESULTS: The pooled sample included a total of 554 participants (308 males and 246 females). Meta-analysis of regression coefficients revealed no significant change in either systolic or diastolic BP per portion FV increase, although there was significant heterogeneity across trials for systolic BP (I2 = 73%). Neither adjusting for change in body mass index, nor analysis according to use of anti-hypertensive medication altered the relationship. There was no significant change in lipid profile per portion FV increase, although there was a significant reduction in total cholesterol among those not on lipid-lowering therapy (P < 0.05 after Bonferroni correction). CONCLUSION: Pooled analysis of six individual FV trials showed no impact of increasing intake on BP or lipids, but there was a total cholesterol-lowering effect in those not on lipid-lowering therapy.

A pathway to earlier discharge following TAVI: Assessment of safety and resource utilization.

INTRODUCTION: There is considerable variability within the population of patients treated with transcatheter aortic valve implantation (TAVI), the procedural approach and time to discharge. In Belfast, from the commencement of our program, our approach has been to perform TAVI by the least invasive approach, where feasible, utilizing a percutaneous transfemoral route and local anesthetic. By analyzing our Belfast TAVI database we identified factors that predicted shorter admission times without impacting adversely on patient safety. Following this, we developed an early discharge pathway. The aim of this current study was to perform a prospective analysis of outcomes in our unit since implementation of this pathway assessing discharge time, mortality, serious adverse events, readmission, and resource implications for patients according to time to discharge. METHODS: Consecutive patients who underwent TAVI and were successfully discharged from 2013 to 2014 over a 14 month period were included, and analyzed according to time to discharge. Baseline and procedural characteristics, mortality, serious adverse events, readmission, and cost were assessed. RESULTS: In total 120 patients were included, 26 (21.7%) were discharged the same/next day, 39 (32.5%) early (>1-4 days), and 55 (45.8%) discharged in the late group. There was no significant difference in baseline or preprocedural characteristics. The incidence of complications was low, and there was no difference in 30-day mortality (P = 0.167) or readmission rates between groups (P = 0.952). Resource analysis revealed the late discharge group cost £3,091.6 more per patient per TAVI than same/next day discharge group. CONCLUSION: Same/next day discharge can be performed safely in appropriately selected patients. Although this will be achieved in a minority of patients (21.7% in this study using an early discharge pathway) it has potential for resource and cost savings. © 2015 Wiley Periodicals, Inc.

Fluoroscopic and electrical assessment of implantable cardioverter defibrillator leads: a prospective observational study.

BACKGROUND: Insulation defects resulting in conductor externalization (CE) have been reported in the Riata family of implantable cardioverter defibrillator (ICD) leads (St. Jude Medical, Sylmar, CA, USA). The aim of this study was to identify, prospectively, the rate of CE and outcomes following this, within a group of patients with a Riata ICD lead. METHODS: Patients with a Riata ICD lead attended for fluoroscopic screening and electrical assessment of the lead at yearly intervals between 2010 and 2012. RESULTS: One hundred and forty patients had no or borderline evidence of CE on initial assessment in 2010. These patients were prospectively followed for 3 years (304.6 patient-years). During this time, 11 patients developed definite CE, equating to an event rate of 3.6 (95% confidence intervals: 1.8-6.5) per 100 patient-years of follow-up. Of those patients developing definite CE, one patient had the ICD lead explanted (for reasons unrelated to CE) and no patients died. CE was not associated with any electrical abnormalities of the ICD lead. CONCLUSIONS: CE was observed at a rate of 3.6 per 100 patient-years of follow-up, in 140 individuals with a Riata ICD lead and no definite evidence of CE at baseline.

Fluoroscopic and electrical assessment of a series of defibrillation leads: prevalence of externalized conductors.

INTRODUCTION: Insulation defects with externalized conductors have been reported in the St. Jude Riata(®) family of defibrillation leads (St. Jude Medical, Sylmar, CA, USA). The objective of the Northern Ireland Riata(®) lead screening program was to identify insulation defects and externalized conductors by systematic fluoroscopic and electrical assessment in a prospectively defined cohort of patients. We sought to estimate the prevalence, identify risk factors, and determine the natural history of this abnormality. METHODS: All patients with a Riata(®) lead under follow-up at the Royal Victoria Hospital were invited for fluoroscopic imaging and implantable cardioverter-defibrillator lead parameter checks. Fluoroscopic images were read independently by two cardiologists and the presence of externalized conductors was classified as positive, negative, or borderline. RESULTS: One hundred and sixty-five of 212 patients with a Riata lead were evaluated by fluoroscopy and lead parameter measurements. The mean duration after implantation was 3.98+/-1.43 years. After screening 25 (15%) patients were classified as positive, 137 (83%) negative, and three (1.8%) borderline. Time since implantation (P = 0.001), presence of a single coil lead (P = 0.042), and patient age (P = 0.034) were significantly associated with externalized conductors. The observed rate of externalized conductors was 26.9% for 8-French and 4.7% for 7-French leads. No leads that were identified prospectively with externalized conductors had electrical abnormalities. Seven of 25 (28%) patients had a defective lead extracted by the end of this screening period. CONCLUSION: A significant proportion (15%) of patients with a Riata lead had an insulation breach 4 years after implantation. High-resolution fluoroscopic imaging in at least two orthogonal views is required to identify this abnormality.

The assessment of vascular function during dietary intervention trials in human subjects.

The potential to reduce cardiovascular morbidity through dietary modification remains an area of intense clinical and scientific interest. Any putatively beneficial intervention should be tested within a randomised controlled trial which records appropriate endpoints, ideally incident CVD and death. However, the large sample sizes required for these endpoints and associated high costs mean that the majority of dietary intervention research is conducted over short periods among either healthy volunteers or those at only slightly increased risk, with investigators using a diverse range of surrogate measures to estimate arterial health in these studies. The present review identifies commonly employed techniques, discusses the relative merits of each and highlights emerging approaches.

A High Polyphenol Diet Improves Psychological Well-Being: The Polyphenol Intervention Trial (PPhIT).

Mental ill health is currently one of the leading causes of disease burden worldwide. A growing body of data has emerged supporting the role of diet, especially polyphenols, which have anxiolytic and antidepressant-like properties. The aim of the present study was to assess the effect of a high polyphenol diet (HPD) compared to a low polyphenol diet (LPD) on aspects of psychological well-being in the Polyphenol Intervention Trial (PPhIT). Ninety-nine mildly hypertensive participants aged 40-65 years were enrolled in a four-week LPD washout period and then randomised to either an LPD or an HPD for eight weeks. Both at baseline and the end of intervention, participants' lifestyle and psychological well-being were assessed. The participants in the HPD group reported a decrease in depressive symptoms, as assessed by the Beck Depression Inventory-II, and an improvement in physical component and mental health component scores as assessed with 36-Item Short Form Survey. No differences in anxiety, stress, self-esteem or body image perception were observed. In summary, the study findings suggest that the adoption of a polyphenol-rich diet could potentially lead to beneficial effects including a reduction in depressive symptoms and improvements in general mental health status and physical health in hypertensive participants.

Prospective Assessment of Linox Implantable Cardioverter Defibrillator Leads for Structural or Electrical Abnormalities.

INTRODUCTION: Insulation failure leading to conductor externalization (CE) of a Linox (Biotronik, Berlin, Germany) implantable cardioverter defibrillator (ICD) lead has recently been reported. The aim of this study was to assess prospectively all Linox family ICD leads implanted at our center for evidence of CE or an electrical abnormality. METHODS: All patients with a Linox family ICD lead implanted at our center, between November 2007 and March 2015, were identified and all living patients were invited to attend for fluoroscopic screening and electrical assessment of the lead. RESULTS: A total of 183 patients had a Linox family ICD lead implanted at our center. Of these, 5 patients (2.7%) had the lead extracted because of electrical failure and 2 of these leads had evidence of CE. Out of 158 living patients with a Linox family ICD lead, 111 patients attended for screening (mean age 63.1 years, 22.5% female). In this group of patients, no cases of CE or electrical abnormalities of the lead were identified. CONCLUSION: In this study evaluating 183 patients with a Linox family ICD lead implanted at a single center, 5 leads (2.7%) were explanted because of electrical failure and 2 of these leads had evidence of CE. Prospective fluoroscopic assessment of 111 Linox family ICD leads, with a mean dwell time of 31.5 months, revealed no further cases of CE.

Analysis of weekend effect on 30-day mortality among patients with acute myocardial infarction.

OBJECTIVES: Several publications have demonstrated increased 30-day mortality in patients admitted on Saturdays or Sundays compared with weekdays. We sought to determine whether this was true for two different cohorts of patients admitted with acute myocardial infarction (MI). METHODS AND RESULTS: Thirty-day mortality data were obtained for 3757 patients who had been admitted to the Belfast Health and Social Care Trust with acute MI between 2009 and 2015. They were subdivided into those presenting with ST elevation MI (n=2240) and non-ST elevation MI (n= 1517). We observed no excess 30-day mortality in those admitted over weekends. CONCLUSION: Excess mortality in patients admitted at weekends is not a universal finding. This may mean that that there are patient subgroups with proportionately greater weekend hazard and points to the need for more detailed understanding of the weekend effect.

Initial Experience of Bioabsorbable Polymer Everolimus-Eluting Synergy Stents in High-Risk Patients Undergoing Complex Percutaneous Coronary Intervention With Early Discontinuation of Dual-Antiplatelet Therapy.

AIMS: As more elderly and co-morbid patients require percutaneous revascularization, 1 year of dual-antiplatelet therapy (DAPT) becomes concerning. Synergy stents (Boston Scientific) allow for early cessation of DAPT. This study assessed those in our unit who underwent percutaneous coronary intervention (PCI) with a Synergy stent to examine a minimum of 6 months of clinical outcomes after early discontinuation of DAPT. METHODS AND RESULTS: All non-trial patients in our unit who had PCI with a Synergy stent from August 2013 to February 2016 were retrospectively analyzed. Follow-up was by medical record review or direct contact for postprocedural complications or adverse events. In total, 185 patients underwent PCI with a Synergy stent over 1 year prior. The mean patient age was 72.0 ± 11.0 years (range, 41-97 years). Stenting involved left main stem (14.1%), multivessel disease (33.0%), and chronic total occlusion (33.0%). DAPT discontinuation occurred in 78.4% by 3 months with no stent thrombosis. Three patients required target-vessel revascularization (TVR) by 1 year. There were no cardiac deaths or myocardial infarctions. Twenty-five patients were able to have non-cardiac procedures within the study period. CONCLUSION: The use of the Synergy everolimus-eluting stent allows for early discontinuation of DAPT, reducing risk of bleeding complications and facilitating non-cardiac procedures, without an increase in stent thrombosis and with excellent results for TVR.

Beneficial effect of a polyphenol-rich diet on cardiovascular risk: a randomised control trial.

OBJECTIVES: There is previous epidemiological evidence that intake of polyphenol-rich foods has been associated with reduced cardiovascular disease risk. We aimed to investigate the effect of increasing dietary polyphenol intake on microvascular function in hypertensive participants. METHODS: All participants completed a 4-week run-in phase, consuming <2 portions of fruit and vegetables (F&V) daily and avoiding berries and dark chocolate. Subjects were then randomised to continue with the low-polyphenol diet for 8 weeks or to consume a high-polyphenol diet of six portions F&V (including one portion of berries/day and 50 g of dark chocolate). Endothelium-dependent (acetylcholine, ACh) and endothelium-independent (sodium nitroprusside) vasodilator responses were assessed by venous occlusion plethysmography. Compliance with the intervention was measured using food diaries and biochemical markers. RESULTS: Final analysis of the primary endpoint was conducted on 92 participants. Between-group comparison of change in maximum % response to ACh revealed a significant improvement in the high-polyphenol group (p=0.02). There was a significantly larger increase in vitamin C, carotenoids and epicatechin in the high-polyphenol group (between-group difference p<0.001; p<0.001; p=0.008, respectively). CONCLUSIONS: This study has shown that increasing the polyphenol content of the diet via consumption of F&V, berries and dark chocolate results in a significant improvement in an established marker of cardiovascular risk in hypertensive participants. TRIAL REGISTRATION NUMBER: NCT01319786.

Clinical Impact of Stent Design.

The introduction and widespread adoption of drug-eluting stents into routine clinical practice has seen tremendous changes in the practice of interventional cardiology. For a prolonged period, manufacturers have focused research on drugs and polymers that are the key to the prevention of in-stent restenosis. However, stent platform design and its clinical implications have now come back to the fore. This has occurred for numerous reasons, but has primarily been driven by the need for modern stents to perform well in increasingly demanding clinical scenarios. This paper reviews the historical evolution of stent platform design. Current manufacturing processes and materials are also explored. Geometric stent construction and its implications for longitudinal stability and the longer term risks of stent fracture are reviewed. Finally, the implications of the specific stent chosen for different clinical applications including the treatment of bifurcations and left main disease are also summarised. This article will familiarise cardiologists with the crucial impact of each of these factors on modern day practice, as well as acute and long-term outcomes for patients.

Late gadolinium enhancement is common in patients with hypertrophic cardiomyopathy and no clinical risk factors for sudden cardiac death: A single center experience.

BACKGROUND: Cardiac magnetic resonance (CMR) is used in the diagnosis and risk stratification of hypertrophic cardiomyopathy (HCM) and can detect myocardial replacement fibrosis (anindependent predictor of adverse cardiac outcomes) using late gadolinium enhancement (LGE). METHODS: We retrospectively analysed CMR studies carried out over a 2 year period identifying those which were diagnostic of HCM. 117 cases were analysed. Mean age of subjects was 53 years and 78 (67%) were male. Mean ejection fraction (EF) was 68.3% with a mean left ventricular (LV) mass index of 89.4 g/m². Hypertrophy was predominantly asymmetric in 94 (80%). RESULTS: All subjects received gadolinium and 80 (68%) had evidence of LGE. LVEF was lower (67 vs. 71%; p = 0.015) and LV mass index higher (94 vs. 81 g/m²; p = 0.007) in the LGE group. The proportion of patients with at least 1 clinical risk factor for sudden cardiac death (SCD) was similar in groups with and without LGE (48% vs. 32%; p = 0.160). In this study, a significant proportion (62%) of patients without clinical risk factors for SCD were found to have LGE on CMR. These patients would not currently be considered for therapy with an implantable cardiac defibrillator. CONCLUSIONS: 1. Patients with HCM are at increased risk of SCD, but identifying patients who may benefit from implantable defibrillators is difficult. 2. LGE is associated with adverse cardiovascular outcomes in HCM, but is present in a large proportion of patients. 3. Many patients without clinical risk factors for SCD have LGE and would not currently be considered for an implantable cardiac device.

The effect of multiple micronutrient supplementation on left ventricular ejection fraction in patients with chronic stable heart failure: a randomized, placebo-controlled trial.

OBJECTIVES: This study sought to investigate the effect of a multiple micronutrient supplement on left ventricular ejection fraction (LVEF) in patients with heart failure. BACKGROUND: Observational studies suggest that patients with heart failure have reduced intake and lower concentrations of a number of micronutrients. However, there have been very few intervention studies investigating the effect of micronutrient supplementation in patients with heart failure. METHODS: This was a randomized, double-blind, placebo-controlled, parallel-group study involving 74 patients with chronic stable heart failure that compared multiple micronutrient supplementation taken once daily versus placebo for 12 months. The primary endpoint was LVEF assessed by cardiovascular magnetic resonance imaging or 3-dimensional echocardiography. Secondary endpoints were Minnesota Living With Heart Failure Questionnaire score, 6-min walk test distance, blood concentrations of N-terminal prohormone of brain natriuretic peptide, C-reactive protein, tumor necrosis factor alpha, interleukin-6, interleukin-10, and urinary levels of 8-iso-prostaglandin F2 alpha. RESULTS: Blood concentrations of a number of micronutrients increased significantly in the micronutrient supplement group, indicating excellent compliance with the intervention. There was no significant difference in mean LVEF at 12 months between treatment groups after adjusting for baseline (mean difference: 1.6%, 95% confidence interval: -2.6 to 5.8, p = 0.441). There was also no significant difference in any of the secondary endpoints at 12 months between treatment groups. CONCLUSIONS: This study provides no evidence to support the routine treatment of patients with chronic stable heart failure with a multiple micronutrient supplement. (Micronutrient Supplementation in Patients With Heart Failure [MINT-HF]; NCT01005303).

Foundation programme impact on junior doctor personality and anxiety in Northern Ireland.

OBJECTIVES: The main objectives of this study were to assess personality traits and levels of anxiety in Foundation Year 2 (F2) doctors during the foundation doctor training programme in the Northern Ireland Deanery (NIMDTA). METHODS: A prospective survey-based study was conducted for all F2 doctors attending the mandatory generic skills programme at NIMDTA. Anxiety was measured using the State-Trait Anxiety Inventory (STAI) while personality was assessed using the IPIP-NEO questionnaire. These previously validated questionnaires were completed at the start and again at the end of the F2 year. RESULTS: 147 (M=65, F=82) and 106 (M=55, F=51) F2 doctors completed questionnaires at both time points. STAI scores suggested a moderate level of anxiety amongst both male and female doctors at baseline and at the end of the academic year. There was no difference between gender for either parameter (Baseline-State: 34.0 vs. 36.0, p=0.48 and Trait: 39.0 vs. 40.5, p=0.33) (End-State: 41.0 vs. 36.0, p=0.14 and Trait: 42.0 vs. 40.5, p=0.78). IPIP-NEO scores for F2 doctors were consistently higher in the Accommodation (93.9 & 92.3) and Consolidation (88.8 & 87.6) personality factors and lower in the Neuroticism factor (66.3 & 65.9) at both assessment time-points. Female F2 doctors scored significantly higher in the accommodation factor at the end of the academic year when compared to their male counterparts (88.0 vs. 94.0, p<0.001). There was no difference between the genders for the other personality factors at the end of the year (p>0.09). CONCLUSION: This first cohort of F2 doctors were exposed to many emerging changes in their training which did not appear to have any detrimental effect on their anxiety levels or personality profiles and suggests that junior doctors may not be affected by external influences or changing educational environments.

The platinum chromium element stent platform: from alloy, to design, to clinical practice.

Despite advances in polymer and drug technology, the underlying stent platform remains a key determinant of clinical outcome. A clear understanding of stent design and the differences between various stent platforms are of increasing importance for the interventional cardiologist. Reduction in stent strut thickness has been associated with improved stent deliverability, improved procedural outcome, and lower rates of subsequent restenosis. Newer-generation 316L-SS stent designs have enabled reduced strut thickness while retaining radial strength and minimizing recoil, but with significant loss of radiopacity, leading to reduced visibility. Cobalt chromium alloys have enabled a reduction in stent strut thickness to around 80-90 mm while retaining modest radiopacity, but due to higher elastic properties, have been associated with greater stent recoil. Development of a novel 33% platinum chromium alloy with high radial strength and high radiopacity has enabled design of a new, thin-strut, flexible, easily visualized, and highly trackable stent platform, the use of which is further illustrated in several clinical case descriptions.