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 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.

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.

Myocardial revascularisation by laser.

Myocardial revascularisation by laser is an emerging treatment for refractory angina in patients with coronary artery disease that is not amenable to conventional revascularisation. With the original technique, laser energy was applied to epicardial surface of the heart through a lateral thoracotomy; so-called transmyocardial laser revascularisation (TMR). It is now possible, using catheter-based percutaneous myocardial revascularisation (PMR) to deliver laser energy to the myocardium via the endocardial surface. In this article we discuss the possible mechanism of action of laser revascularisation, and summarise the results of recent randomised controlled trials of TMR, PMR systems are described, and the growing evidence for their efficacy is reviewed.

Trials comparing coronary artery bypass grafting with percutaneous transluminal coronary angioplasty and primary stent implantation in patients with multivessel coronary artery disease.

With marked improvements in stent technology as adjunct to balloon angioplasty for multivessel coronary disease, several newer trials are currently in progress reviewing the optimal revascularization strategy. This review provides background from older studies and addresses the current progress and design of these newer trials.

The study of nursing intervention in practice (SNIP).

The creation of a new role for an advanced nurse practitioner in cardiovascular medicine is being evaluated in a prospective randomised controlled trial--the study of nursing intervention in practice (SNIP).

Design of the 'Stent or Surgery' trial (SoS): a randomized controlled trial to compare coronary artery bypass grafting with percutaneous transluminal coronary angioplasty and primary stent implantation in patients with multi-vessel coronary artery disease.

The 'Stent or Surgery' trial (SoS) is a randomized controlled trial to compare coronary artery bypass grafting with percutaneous transluminal coronary angioplasty and primary stent implantation in patients with multi-vessel coronary artery disease. This is a multicentre, multinational venture involving over 40 centres in 12 countries throughout Europe and Canada. Eligible and consenting patients will be randomly allocated, in equal proportions, to open revascularization by CABG or by PTCA with the primary implantation of intracoronary stents. The trial design is pragmatic and imposes few protocol restrictions in patient selection, surgical and intervention techniques or adjunctive medication schedules. The rationale and design of the trial are discussed, including important sub-studies, examining quality of life, neuropsychological outcome, cost and cost benefit.