A comparison of angina symptoms reported by clinicians and patients, pre and post revascularisation: Insights from the Stent or Surgery Trial.

BACKGROUND: There are limited data comparing the consistency of angina reporting by patients and clinicians. METHODS: We performed a retrospective analysis of data from the randomised Stent or Surgery (SoS) trial. The trial required reporting of angina using the Canadian Cardiovascular Society (CCS) classification by both patients and clinicians at baseline and twelve months. We compared paired observations to describe the magnitude and direction of differences in clinician and patient reporting. The difference in CCS grade was expressed as the clinician minus patient value. We also examined the proportion of trial subjects reported as being free from angina (CCS = 0) in clinician and patient reporting. RESULTS: Paired CCS data was available for 912 and 887 cases at baseline and 12 months respectively. At baseline, clinicians reported freedom from angina in a single case (1/912 = 0.1%) compared to 70/912 (7.7%) patients (Delta 7.6% 95% CI 5.8 to 9.3, P ≤0.001). At 12 months, the position was reversed, with clinicians reporting 639/887 (72%) angina free compared to 449/887 (50.6%) for patients (Delta -21.4 95% CI -17.1 to -25.8 P ≤ 0.001). For the reported CCS grade at follow-up, the weighted linear kappa for overall agreement was 0.312. Discordant reporting involved the clinician suggesting less angina rather than more (36% v 8% of cases). CONCLUSIONS: These findings have implications for our perception of previous research which has, in the main, focussed on clinician reporting. This emphasises the importance of patient reporting and a need to better understand reasons for discordance.

The impact of continuous haemofiltration with high-volume fluid exchange during cardiopulmonary bypass surgery on the recovery of patients with impaired renal function: a pilot randomised trial.

BACKGROUND: There is widespread variability in clinical practice within cardiac surgery units worldwide on the use of haemofiltration. The clinical impact and safety of this modality is, however, unknown. OBJECTIVES: The primary pilot trial objectives were as follows: to assess the feasibility of randomising 60 patients with impaired kidney function undergoing on-pump coronary artery bypass graft (CABG) surgery within 6 months; to assess the suitability and reliability of our chosen outcome measures; to explore issues that may impact on recruitment into a definitive trial; and to undertake an exploratory economic evaluation. DESIGN: A pilot, single-centre, open-label randomised trial. SETTING: Liverpool Heart and Chest Hospital NHS Foundation Trust between November 2010 and March 2012. PARTICIPANTS: Men and women, aged > 18 years of age, undergoing on-pump CABG surgery, who had pre-operative impaired kidney function indicated by an estimated glomerular filtration rate (eGFR) of < 60 ml/minute adjusted for 1.73 m(2) of body surface area. INTERVENTIONS: Group 1: patients who received haemofiltration during bypass (experimental group). Group 2: patients who did not receive haemofiltration during bypass (control group). MAIN OUTCOME MEASURES: (1) Feasibility outcome measures: barriers to recruitment to a larger trial were documented as observations made during the recruitment period of the trial. Reliability of data collection methods was monitored using a 13-point case record form validation check for data entry against the patient clinical notes and the trial database. (2) The main clinical outcomes were frequency of intensive care unit (ICU) stay of duration > 3 days and the length of ICU stay days. (3) Other clinical outcomes were the need for postoperative haemofiltration in the ICU, mechanical ventilation time, hospital stay, composite of outcome of unfavourable perioperative events and eGFR values at 6 weeks' follow-up. (4) Secondary health economic feasibility outcomes. RESULTS: Recruitment into the pilot trial was from 21 November 2010 to 30 March 2012. Thirty-seven eligible patients were consented and successfully randomised into the trial arms (30%). The main issues impacting on recruitment were the high volume of off-pump CABG surgery within the centre; recruitment being restricted to research nurses' working hours of the week; issues arising associated with the screening process for identifying prospective eligible patients based on eGFR values; protocol deviations/treatment crossovers; and unexpected outbreaks of pandemic influenza and other infectious conditions. The data collection process was sufficiently robust, with few errors detected. The length of ICU stay days was deemed a suitable primary outcome. There was an overall trend towards reduction in the length of ICU stay for patients who were given intraoperative haemofiltration, more so for those with diabetes. The economic evaluation estimated that the incremental costs per person were £1744 lower for the intraoperative haemofiltration group, while the incremental benefits per person increased by 0.11. CONCLUSION: Given sufficient resources and broadening of the inclusion criteria, the recruitment into a larger multicentre trial is feasible and may demonstrate potential clinical and cost benefits of using intraoperative haemofiltration in this group of patients. However, owing to the small sample size in this pilot trial, no firm conclusions can be drawn from the findings at this stage. The outcomes of this pilot study are very encouraging and suggest that it is feasible to design a continuous superiority trial with the length of ICU stay days or time to tracheal extubation as the primary outcome measure, provided that guidelines for avoiding bias are implemented. An alternative primary outcome measure that avoids bias is mortality. The inclusion criteria should also be widened to include all cardiac surgery patients with impaired renal function. TRIAL REGISTRATION: ISRCTN49513454. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 49. See the HTA programme website for further project information.

A pilot randomised controlled trial in intensive care patients comparing 7 days' treatment with empirical antibiotics with 2 days' treatment for hospital-acquired infection of unknown origin.

BACKGROUND: Management of cardiac intensive care unit (ICU) sepsis is complicated by the high incidence of systemic inflammatory response syndrome, which mimics sepsis but without an infective cause. This pilot randomised trial investigated whether or not, in the ICU, 48 hours of broad-spectrum antibiotic treatment was adequate to safely treat suspected sepsis of unknown and unproven origin and also the predictive power of newer biomarkers of sepsis. OBJECTIVE: The main objective of this pilot study was to provide preliminary data on the likely safety and efficacy of a reduced course of antibiotics for the treatment of ICU infections of unknown origin. DESIGN: A pilot, single-centre, open-label randomised trial. SETTING: This study was carried out in the ICU of a tertiary heart and chest hospital. PARTICIPANTS: Patients being treated within the ICU were recruited into the trial if the intensivist was planning to commence antibiotics because of evidence of systemic inflammatory response syndrome and a strong suspicion of infection but there was no actual known source for that infection. INTERVENTIONS: Broad-spectrum antibiotic treatment administered for 48 hours (experimental) compared with treatment for 7 days (control). MAIN OUTCOME MEASURES: The primary outcome was a composite outcome of the rate of death or initiation of antibiotic therapy after the completion of the treatment schedule allocated at randomisation. Secondary outcomes included the duration of mechanical ventilation and ICU and hospital stay; the incidence of infection with Clostridium difficile (B. S. Weeks & E. Alcamo) Jones & Bartlett International Publishers, 2008, or methicillin-resistant Staphylococcus aureus (MRSA) (B. S. Weeks & E. Alcamo) Jones & Bartlett International Publishers, 2008; resource utilisation and costs associated with each of the two pilot arms; the ratio of patients screened to patients eligible to patients randomised; the incidence of crossover between groups; and the significance of newer biomarkers for sepsis for predicting patients' need for further antibiotics. RESULTS: A total of 46 patients were recruited into the trial, with 23 randomised to each group. There was no significant difference between the two groups in terms of the composite primary outcome measure. The risk difference was 0.12 [95% confidence interval (CI) 0.11 to 0.13; p = 0.3]. In the 2-day group, four patients (17.4%) required further antibiotics compared with three (13%) in the 7-day group. Four patients died within the trial period and the deaths were not trial related. Patients who died during the trial period received no additional antibiotics in excess of their trial allocation. There were no documented incidences of MRSA or C. difficile infection in either group. No significant differences in adverse events were observed between the groups. Key economic findings were mean antibiotic costs per patient of £168.97 for the 2-day group and £375.86 for the 7-day group. The potential per annum cost saving for the ICU of 2-day treatment was estimated to range from £108,140 to £126,060. Patient screening was considered the biggest barrier to recruitment. There was no crossover between the two randomised groups. Data verification ascertained > 98% accuracy in data collection. Baseline procalcitonin was found to be predictive of the composite outcome (death and needing further antibiotics) (odds ratio 1.79, 95% CI 1.20 to 2.67; p = 0.005). Analysis of baseline procalcitonin also indicated a trend towards it being a predictor of restarting antibiotics, with an odds ratio of 1.45 (95% CI 1.04 to 2.02; p = 0.01). CONCLUSIONS: Data from this pilot study suggest that there could be significant benefits of reducing broad-spectrum antibiotic use in the ICU without it undermining patient safety, with a potential cost saving in our unit of over £100,000 per year. Evidence from this pilot trial is not definitive but warrants further investigation using a large randomised controlled trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN82694288. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 36. See the HTA programme website for further project information.

Issues in online patient self-reporting of health status.

Patient self-reporting of symptoms and quality of life following surgical interventions is generally delivered in the form of paper-based questionnaires to be completed in the outpatient clinic or at home. A commonly used tool for patient self-reporting of quality of life is the EQ5D health status questionnaire which, while limited in scope, has general applicability across a range of health interventions. In this article we examine the issues relating to online patient self-reporting using this questionnaire and the wider implications for the online reporting of health status.

The impact of diabetes mellitus on two-year mortality following contemporary percutaneous coronary intervention: implications for revascularization practice.

OBJECTIVE: To assess the impact of diabetes on 2-year mortality in current PCI practice. BACKGROUND: In patients with coronary artery disease undergoing revascularization, diabetes mellitus is associated with higher mortality. METHODS: A retrospective analysis was done of all patients undergoing PCI at our tertiary center between January 2000 and December 2004. There were 6,160 PCI procedures performed in 5,759 patients who received at least one stent. Of these patients, 801 (13.9%) were diabetic and 4,958 (86.1%) were nondiabetic. The primary outcome measure of the study was all-cause mortality. All patients were followed up for a period of 2 years. Multivariate logistic regression analysis was used to test for a potential independent association between diabetic status and follow-up mortality. RESULTS: Before adjustment, a trend toward higher mortality was observed in diabetic patients compared to non-diabetics at 1 year (3.2% vs 2.4%) and 2 years (5.1% vs 3.8%), P = 0.12. Independent predictors for mortality were increasing age, renal dysfunction, peripheral vascular disease, NYHA class >2, urgent PCI, treating left main stem lesions, vessel diameter < or = 2.5 mm, and 3-vessel disease. The use of drug-eluting stent was associated with a reduction in mortality. Diabetes was found to have no independent impact on mortality following PCI (odds ratio = 1.08; 95% confidence intervals = 0.73-1.60; P = 0.71). CONCLUSION: The presence of diabetes was not an independent predictor of mortality following PCI. A diabetic patient that does not require insulin treatment and has no evidence of macro- or microvascular diabetic disease could enjoy a PCI outcome similar to nondiabetic subjects.

Intermediate and high peri-operative cardiac enzyme release following isolated coronary artery bypass surgery are independently associated with higher one-year mortality.

BACKGROUND: The relationship between cardiac enzyme (CE) release following coronary artery bypass surgery (CABG) and medium term outcome is unclear. We sought to determine the relationship between post-operative CE release and one-year survival following isolated CABG. METHODS: Over three years 3,024 consecutive patients underwent isolated CABG. Patient characteristics were prospectively recorded in a cardiac surgical database. CE release, taken as the highest single measurement recorded in the first 24 hours post-op, was abstracted from an electronic archive. All cause mortality was taken from a national registry of deaths. RESULTS: Data were complete for 2,860 (94.6%) patients. CK-MB isoenzyme (reference range 5-24 U/l) was recorded in 2,568 (89.8%), total CK in 292 (10.2%). CE release three or more times the upper limit of the reference range (ULR) were recorded in 498 (17.4%) patients, 163 (5.7%) patients had CE more than six times ULR. There were 122 deaths (4.3%). Cox proportional hazards analysis showed that CE release 3-6 times ULR (adjusted HR 2.1 [95% CI: 1.6 to 2.6], p = 0.002) and CE release six or more times the ULR (adjusted HR 5.0 [95% CI: 4.5 to 5.4], p < 0.001) were independently associated with increased one-year mortality. CONCLUSION: Cardiac enzyme release following CABG is associated with increased one-year all-cause mortality. The definition of peri-operative myocardial infarction following CABG should include elevation of CK-MB three or more times the upper limit of normal.

Multivariate prediction of major adverse cardiac events after 9914 percutaneous coronary interventions in the north west of England.

OBJECTIVE: To develop a multivariate prediction model for major adverse cardiac events (MACE) after percutaneous coronary interventions (PCIs) by using the North West Quality Improvement Programme in Cardiac Interventions (NWQIP) PCI Registry. SETTING: All NHS centres undertaking adult PCIs in north west England. METHODS: Retrospective analysis of prospectively collected data on 9914 consecutive patients undergoing adult PCI between 1 August 2001 and 31 December 2003. A multivariate logistic regression analysis was undertaken, with the forward stepwise technique, to identify independent risk factors for MACE. The area under the receiver operating characteristic (ROC) curve and the Hosmer-Lemeshow goodness of fit statistic were calculated to assess the performance and calibration of the model, respectively. The statistical model was internally validated by using the technique of bootstrap resampling. MAIN OUTCOME MEASURES: MACE, which were in-hospital mortality, Q wave myocardial infarction, emergency coronary artery bypass graft surgery, and cerebrovascular accidents. RESULTS: Independent variables identified with an increased risk of developing MACE were advanced age, female sex, cerebrovascular disease, cardiogenic shock, priority, and treatment of the left main stem or graft lesions during PCI. The ROC curve for the predicted probability of MACE was 0.76, indicating a good discrimination power. The prediction equation was well calibrated, predicting well at all levels of risk. Bootstrapping showed that estimates were stable. CONCLUSIONS: A contemporaneous multivariate prediction model for MACE after PCI was developed. The NWQIP tool allows calculation of the risk of MACE permitting meaningful risk adjusted comparisons of performance between hospitals and operators.

The SV stent study: a prospective, multicentre, angiographic evaluation of the BiodivYsio phosphorylcholine coated small vessel stent in small coronary vessels.

OBJECTIVE: To evaluate the use of the phosphorylcholine (PC) coated BiodivYsio small vessel (SV) stent in native coronary vessels of small calibre. DESIGN AND SETTING: Prospective, multi-centre, multi-national registry with 6-month clinical and core-lab angiographic follow-up. Adverse events were adjudicated by a Clinical Events Committee (CEC) and included peri-procedural analysis of cardiac enzymes. PATIENTS: Patients with signs or symptoms of ischaemia with an identified target lesion in an epicardial vessel with reference diameter 2.0-2.75 mm were enrolled. Intervention in other epicardial territories in the same patient was permitted. RESULTS: Recruitment of 150 consecutive lesions (in 143 patients) was completed in 19 centres in Europe and Israel. The stent was deployed successfully in all but one lesion. At 6 months, 1 patient (1%) had experienced sudden cardiac death, 4 further patients (3%) had a non-Q wave MI, and a further 24 patients (17%) had repeat revascularisation of a study target vessel. The mean reference vessel diameter prior to stenting was 2.2 mm (S.D. 0.4). Mean minimal luminal diameters at pre-procedure, post procedure and follow-up were 0.6 mm (S.D. 0.3), 2.0 mm (S.D. 0.4) and 1.2 mm (S.D. 0.6), respectively. The late lumen loss index was 0.55 (S.D. 0.53) with a binary restenosis rate of 32%. CONCLUSIONS: In stenting of selected lesions in small vessels, the BiodivYsio SV stent demonstrated high rates of implant success. The rates of major adverse cardiac events (MACE), angiographic restenosis and repeat revascularisation are similar to those reported in other small vessel bare metal stent studies.

One year comparison of costs of coronary surgery versus percutaneous coronary intervention in the stent or surgery trial.

OBJECTIVES: To compare initial and one year costs of coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) in the stent or surgery trial. DESIGN: Prospective, unblinded, randomised trial. SETTING: Multicentre study. PATIENTS: 988 patients with multivessel disease. INTERVENTIONS: CABG and stent assisted PCI. MAIN OUTCOME MEASURES: Initial hospitalisation and one year follow up costs. RESULTS: At one year mortality was 2.5% in the PCI arm and 0.8% in the CABG arm (p = 0.05). There was no difference in the composite of death or Q wave myocardial infarction (6.9% for PCI v 8.1% for CABG, p = 0.49). There were more repeat revascularisations with PCI (17.2% v 4.2% for CABG). There was no significant difference in utility between arms at six months or at one year. Quality adjusted life years were similar 0.6938 for PCI v 0.6954 for PCI, Delta = 0.00154, 95% confidence interval (CI) -0.0242 to 0.0273). Initial length of stay was longer with CABG (12.2 v 5.4 days with PCI, p < 0.0001) and initial hospitalisation costs were higher (7321 pounds sterling v 3884 pounds sterling for PCI, Delta = 3437 pounds sterling, 95% CI 3040 pounds sterling to 3848 pounds sterling). At one year the cost difference narrowed but costs remained higher for CABG (8905 pounds sterling v 6296 pounds sterling for PCI, Delta = 2609 pounds sterling, 95% CI 1769 pounds sterling to 3314 pounds sterling). CONCLUSIONS: Over one year, CABG was more expensive and offered greater survival than PCI but little added benefit in terms of quality adjusted life years. The additional cost of CABG can be justified only if it offers continuing benefit at no further increase in cost relative to PCI over several years.

A randomised controlled trial to compare a nurse practitioner to medical staff in the preparation of patients for diagnostic cardiac catheterisation: the study of nursing intervention in practice (SNIP).

BACKGROUND: A number of initiatives have employed nurses in roles traditionally associated with the medical profession but few have been evaluated in prospective randomised studies. This paper reports the results of a randomised controlled trial to assess the performance of a nurse practitioner (NP), trained to prepare patients for diagnostic cardiac catheterisation. METHODS: Eligible and consenting patients were randomised to preparation by either the NP or junior medical staff (JMS). The safety outcome measure was the rate of in-hospital major adverse clinical events including death, myocardial infarction and emergency bypass coronary surgery. Other outcome measures included rate of minor adverse events, cardiologist assessment of case preparation and presentation, patient satisfaction and duration of pre-admission clinic. RESULTS: From April 1997 to May 1998 a series of 355 patients scheduled for elective, day-case, diagnostic cardiac catheterisation were screened. Of these, 345 patients were eligible for the study. A total of 339 patients consented to participate and were randomised. Major adverse clinical events occurred in 0/175 (0%) patients in the NP group and 2/161 (1.2%) patients in the JMS group. (Risk difference = -1.2%, upper boundary of the 95% confidence interval = +2.0%) The cardiologist's evaluation that the patient's preparation was acceptable was high in both groups: NP group 98.3% vs. JMS group 98.8%: P = 1.0). Patient satisfaction, assessed by questionnaire, was greater in the NP group (P = 0.04). The median duration of the pre-admission clinic visit was lower in the NP group 165 min vs. 185 min in the JMS group, P = 0.01). CONCLUSIONS: The preparation of patients for diagnostic cardiac catheterisation can be safely performed by an appropriately trained NP. This approach may be associated with improved patient satisfaction and reduced clinic duration times.

Permanent pacemaker implantation via the femoral vein: an alternative in cases with contraindications to the pectoral approach.

BACKGROUND: This paper presents a consecutive series of permanent pacemakers (PPM) implanted via the femoral vein in patients with contraindications to pacing systems via the superior vena cava (SCV). The femoral vein approach is a less invasive and feasible alternative to epicardial lead placement. METHODS: Twenty-seven patients had femoral pacemakers inserted. Indications for femoral vein pacemaker insertion were: SVC/subclavian obstruction (12 patients, 44.4%), previous infection in SVC leads (four patients, 14.8%), mastectomy and/or radiotherapy to chest (four patients, 14.8%), multiple leads in SVC (two patients, 7.4%), recurrent erosion (two patients, 7.4%), abnormal anatomy (one patient, 3.7%), painful pacemaker pocket (one patient, 3.7%) and burns (one patient, 3.7%). Fifty-one leads, 25 atrial and 26 ventricular, were inserted. The majority of leads were active fixations (96% of atrial leads and 85% ventricular leads). RESULTS: During a mean follow-up of 36.5 months (range 0.9-116.5), six additional unplanned procedures were performed in four patients. Atrial lead displacement occurred in five leads (20%). There were no ventricular lead displacements. In two patients, box revision for pre-erosion was required. One patient had persistent pain at the site of abdominal pacemaker generator. Infection, thromboembolic events, thromophlebitis, evidence of lower limb venous occlusion and lead fracture did not occur. CONCLUSION: Femoral vein PPM are a simple and feasible alternative in patients in whom the SVC approach is contraindicated.

Femoral haemostasis after transcatheter therapeutic intervention: a prospective randomised study of the angio-seal device vs. the femostop device.

BACKGROUND: A number of haemostatic devices are available to facilitate early haemostasis following transfemoral interventional procedures. METHODS AND RESULTS: We have prospectively compared 150 patients (age: 57+/-12 years, mean+/-S.D.) who were randomly assigned to either external compression using the FemoStop device or direct closure of the arterial puncture using the Angio-Seal device. The Angio-Seal was deployed in the catheter laboratory after the conclusion of the procedure. Patients, randomised to FemoStop, had their sheath removed when the activated clotting time (ACT) was less than 100 s before applying the device. The primary endpoint was the composite of bleeding, haematoma formation, bruise, requirement for blood transfusion, clinical indication for ultrasound examination at 2 h and 24 h following the procedure and crossover to either method at 2 and 24 h after the device deployment. The 95% of the Angio-Seal and 96% of FemoStop patients were discharged on the day following the procedure. An increased number of patients in the Angio-Seal group reached a clinical end-point within the first 2 h (45% vs. 3%, P<0.0001). This difference became insignificant at 24 h (25% vs. 30%, P=0.6). CONCLUSION: Although less comfortable, the overall efficacy of the FemoStop appeared to be higher than that of the Angio-Seal device.

Comparison of the incidence of complications at induction and emergence in infants receiving oral atropine vs no premedication.

We studied 120 patients less than 1 yr of age, allocated randomly to receive atropine 40 micrograms kg-1 orally 1 h before operation (group A) or no premedication (group B). All patients underwent a standardized anaesthetic, including inhalation induction with halothane followed by atracurium 0.5 mg kg-1, tracheal intubation and positive pressure ventilation. Monitoring during anaesthesia included heart rate, arterial oxygen saturation, temperature and airway conditions at induction and emergence. The incidence of a decrease in arterial oxygen saturation to 94% or less at induction and recovery was similar in both groups (30.5% at induction, 39% at extubation in group A; 31% at induction, 41% at extubation in group B). There were significantly more airway complications in group B both at induction and emergence (25% and 49%, respectively, compared with 9% and 25% in group A; P < 0.015). Mean heart rate at induction and in the peroperative period was significantly higher in the group receiving atropine (P < or = 0.001). There was an increased incidence of bradycardia (decrease in heart rate of > or = 20%) at induction in the non-premedicated group (23% in group B compared with 10% in group A), but this was not statistically significant. We conclude that the incidence of airway complications at induction and emergence was reduced by orally administered atropine premedication.