Supporting anticoagulant treatment decision making to optimise stroke prevention in complex patients with atrial fibrillation: a cluster randomised trial.

BACKGROUND: Anticoagulation for preventing stroke in atrial fibrillation is under-utilised despite evidence supporting its use, resulting in avoidable death and disability. We aimed to evaluate an intervention to improve the uptake of anticoagulation. METHODS: We carried out a national, cluster randomised controlled trial in the Australian primary health care setting. General practitioners received an educational session, delivered via telephone by a medical peer and provided information about their patients selected either because they were not receiving anticoagulation or for whom anticoagulation was considered challenging. General practitioners were randomised to receive feedback from a medical specialist about the cases (expert decisional support) either before or after completing a post-test audit. The primary outcome was the proportion of patients reported as receiving oral anticoagulation. A secondary outcome assessed antithrombotic treatment as appropriate against guideline recommendations. RESULTS: One hundred and seventy-nine general practitioners participated in the trial, contributing information about 590 cases. At post-test, 152 general practitioners (84.9%) completed data collection on 497 cases (84.2%). A 4.6% (Adjusted Relative Risk = 1.11, 95% CI = 0.86-1.43) difference in the post-test utilization of anticoagulation between groups was not statistically significant (p = 0.42). Sixty-one percent of patients in both groups received appropriate antithrombotic management according to evidence-based guidelines at post-test (Adjusted Relative Risk = 1.0; 95% CI = 0.85 to 1.19) (p = 0.97). CONCLUSIONS: Specialist feed-back in addition to an educational session did not increase the uptake of anticoagulation in patients with AF. TRIAL REGISTRATION: ANZCTRN12611000076976 Retrospectively registered.

Evaluation of Serial High Sensitivity Troponin T Levels in Individuals Without Overt Coronary Heart Disease Following Exercise Stress Testing.

BACKGROUND: Detectable levels of high sensitivity (cardiac) troponin T (HsTnT), occur in the majority of patients with stable coronary heart disease (CHD), and often in 'healthy' individuals. Extreme physical activity may lead to marked elevations in creatine kinase MB and TnT levels. However, whether HsTnT elevations occur commonly after exercise stress testing (EST), and if so, whether this has clinical significance, needs clarification. METHODS: To determine whether HsTnT levels become elevated after EST (Bruce protocol) to ≥95% of predicted maximum heart rate in presumed healthy subjects without overt CHD, we assayed HsTnT levels for ∼5h post-EST in 105 subjects (median age 37 years). RESULTS: Pre-EST HsTnT levels <5 ng/L were present in 31/32 (97%) of females and 52/74 (70%) of males. Post-EST, 13 (12%) subjects developed HsTnT levels >14 ng/L, with troponin elevation occurring at least three hours post-EST. Additionally, a detectable ≥ 50% increase in HsTnT levels (4.9→9ng/L) occurred in 28 (27%) of subjects who during EST achieved ≥ 95% of their predicted target heart rate. The median age of the subjects with HsTnT elevations to > 14ng/L post-EST was higher than those without such elevation (42 and 36 years respectively; p=0.038). At a median follow-up of 13 months no adverse events were recorded. CONCLUSION: The current study demonstrates that detectable elevations occur in HsTnT post-EST in 'healthy' subjects without overt CHD. Future studies should evaluate the clinical significance of detectable elevations in post-EST HsTnT with long-term follow-up for adverse cardiac events.

Worsening renal function in heart failure: the need for a consensus definition.

Acute decompensated heart failure is a common cause of hospitalisation. This is a period of vulnerability both in altered pathophysiology and also the potential for iatrogenesis due to therapeutic interventions. Renal dysfunction is often associated with heart failure and portends adverse outcomes. Identifying heart failure patients at risk of renal dysfunction is important in preventing progression to chronic kidney disease or worsening renal function, informing adjustment to medication management and potentially preventing adverse events. However, there is no working or consensus definition in international heart failure management guidelines for worsening renal function. In addition, there appears to be no concordance or adaptation of chronic kidney disease guidelines by heart failure guideline development groups for the monitoring of chronic kidney disease in heart failure. Our aim is to encourage the debate for an agreed definition given the prognostic impact of worsening renal function in heart failure. We present the case for the uptake of the Acute Kidney Injury Network criteria for acute kidney injury with some minor alterations. This has the potential to inform study design and meta-analysis thereby building the knowledgebase for guideline development. Definition consensus supports data element, clinical registry and electronic algorithm innovation as instruments for quality improvement and clinical research for better patient outcomes. In addition, we recommend all community managed heart failure patients have their baseline renal function classified and routinely monitored in accordance with established renal guidelines to help identify those at increased risk for worsening renal function or progression to chronic kidney disease.

Vaso-vagal reactions during femoral arterial sheath removal after percutaneous coronary intervention and impact on cardiac events.

We determined whether vaso-vagal syncope during sheath removal after percutaneous coronary intervention leads to a higher incidence of major adverse cardiac events including acute stent thrombosis, in 611 patients who participated in our previous trial assessing the impact of intravenous sedation and local anaesthesia at this time on patient comfort. A total of 35 (5.7%) patients experienced a vaso-vagal reaction. Major adverse cardiac events at day 30 occurred in 5.7% of patients experiencing vaso-vagal syncope and 7.1% of those who did not (p=1.00) with no case of stent thrombosis in the vaso-vagal group. Whilst unpleasant for patients, we conclude that vaso-vagal syncope during sheath removal after percutaneous coronary intervention is not associated with increased adverse cardiac events in the stent era.

Unfractionated heparin use after percutaneous coronary intervention: results of a trial with a vascular ultrasound endpoint.

BACKGROUND: Previous studies in the pre-stent era have evaluated the postprocedural use of unfractionated heparin (UFH) on clinically defined vascular complications and ischaemic cardiac complications. We prospectively evaluated the benefits and risks of this practice, using vascular ultrasound determined endpoints in the current stent era. METHODS: Patients undergoing percutaneous coronary intervention (PCI) and enrolled in two of our previous routine and prospective vascular ultrasound studies were included in the analysis. Generally the decision to use UFH after sheath removal was at the discretion of the operator, however a subset of patients was randomised to receive UFH or not. Femoral vascular ultrasound was performed prior to hospital discharge and interpreted by an experienced vascular ultrasonographer blinded to whether UFH was used or not. The primary endpoint was a composite of significant vascular ultrasound determined complications including major haematoma, pseudoaneurysm, arterio-venous fistula, femoral venous or arterial thrombosis and retroperitoneal haemorrhage. Secondary endpoints included in hospital ischaemic events, length of stay and outcome at 30 days. RESULTS: A total of 530 patients (43% receiving UFH) were included in the analysis. The incidence of the primary endpoint for the entire population was 4.0% in both the UFH and no UFH groups (p=1.00). In the 226 (43%), randomised patient subset, the primary endpoint occurred in 5.2% in the UFH group and 4.5% in the no UFH group (p=0.80). Time to ambulation and discharge was similar in both groups. At 30 days, the incidence of major adverse cardiac events (4.7% for entire cohort) was similar in all groups whether randomised or not. CONCLUSIONS: When vascular ultrasound is used to determine major vascular complications the use of UFH after PCI in the stent era was not associated with increased major vascular complications. We also failed to provide evidence of a meaningful clinical benefit with the routine use of postprocedural heparin in this selected patient cohort.

Effect of local anesthesia and intravenous sedation on pain perception and vasovagal reactions during femoral arterial sheath removal after percutaneous coronary intervention.

BACKGROUND: There is no consensus with respect to the use of analgesia during femoral arterial sheath removal after percutaneous coronary intervention (PCI). We performed a randomized controlled trial to assess the impact of intravenous sedation and local anesthesia during femoral sheath removal after PCI on patient comfort and the incidence of vasovagal reactions. METHODS: All patients undergoing PCI whose femoral sheaths were to be removed with assisted manual compression were eligible. Patients were randomized to receive either intravenous sedation (Fentanyl and Midazolam) or local anesthesia (1% lignocaine) infiltrated around the sheath site or both or neither. The primary endpoint of the study was the patients reported worst pain according to a Visual Analogue scale (VAS) after sheath removal. The incidence and predictors of vasovagal reactions during sheath removal and occurrence of vascular complications was also determined. RESULTS: A total of 611 patients were randomized into this study. The mean pain score was highest in the local anesthesia only arm as compared to the sedation only arm, the combined local and sedation arm and the neither sedation or local arm (p=0.001). vasovagal reactions were experienced by 35 patients (5.1%) with the highest percentage in the local anesthesia only group (9.8%). Multivariate logistic regression analysis identified a higher pain score (OR 1.18, 95% CI 1.12-1.24, p=0.001), use of glyceryl trinitrate during sheath removal (OR 9.05, 95% CI 5.06-16.1, p<0.001), a lower body mass index (OR 1.12, 95% CI 1.08-1.18, p=0.009) and the left anterior descending artery as the treated vessel (OR 5.2, 95% CI 3.41-7.87, p<0.001) as independent predictors of the occurrence of a vasovagal reaction. There was no significant difference in vascular complications between the 4 study groups. CONCLUSIONS: The routine use of fentanyl and midazolam prior to sheath removal leads to a reduction in pain perception and vasovagal incidence, whilst the routine use of local infiltration during sheath removal should be discouraged as it leads to more pain and a trend to more vasovagal reactions.

Gender and age differences in the prevalence of coronary artery calcification in 953 Chinese subjects.

BACKGROUND: To investigate gender and age differences in coronary artery calcium (CAC) as determined by electron beam computed tomography (EBCT) in a Chinese population. METHODS: Consecutive patients undergoing EBCT were subdivided into groups based on gender and decades of life. They were further subdivided into three groups with respect to symptoms of coronary artery disease: typical, atypical and asymptomatic. Total calcium score was calculated for each patient and means calculated for each subgroup. Groups were then compared with respect to age, gender and symptoms. RESULTS: During the study period, 953 patients (736 men and 217 female) aged 17-86 years (mean 55+/-11 years) underwent EBCT. The prevalence of CAC increased significantly with increasing age. The mean total calcium score also increased with increasing age in males and females of each symptom subgroup. The prevalence of coronary artery calcification was significantly higher in males than females until age in excess of 69 years (p<0.05). The prevalence of coronary artery calcification and mean calcium scores were significantly different between each symptom subgroup (p<0.001) with higher scores and prevalence in patients with typical symptoms of coronary disease. CONCLUSIONS: There is an increase in the prevalence of coronary artery calcification with age in Chinese subjects. Male subjects are more likely than female subjects to have detectable coronary calcification up until an age in excess of 69 years. Patients under the age of 70 years, with typical symptoms of coronary artery disease have a higher prevalence and mean calcium score than those with atypical or no symptoms.

Adverse reactions of low osmolar non-ionic and ionic contrast media when used together or separately during percutaneous coronary intervention.

BACKGROUND: Due to perceived advantages in the use of non-ionic contrast agents for diagnostic angiography and ionic agents for percutaneous coronary intervention (PCI), patients often receive various combinations of both types of agents. AIM: To assess potential adverse effects of non-ionic and ionic contrast media when used together or separately during percutaneous coronary intervention. METHODS: We retrospectively evaluated the outcomes of 532 patients undergoing percutaneous coronary intervention in our institution. Patients were divided into two groups: those that underwent diagnostic angiography and "follow on" PCI; and those that underwent "planned" PCI. The groups were subdivided on the basis of the use of the ionic agent ioxaglate or the non-ionic agent iopromide during PCI. The frequency of allergic reactions and major adverse cardiac events (MACE) were noted. RESULTS: With respect to the "follow on" group, allergic reactions occurred in 9 of 150 patients (6.0%) who received the combination of ioxaglate and iopromide versus 1 of 93 (1.1%) who only received iopromide (p=0.094). There was no difference with respect to MACE [6 (4.0%) ioxaglate and iopromide versus 4 (4.3%) iopromide alone, p=1.00]. In the "planned" group, 7 of 165 patients (4.2%) receiving ioxaglate had an allergic reaction as opposed 0.0% (0 of 124 patients) in the iopromide group (p=0.021). All contrast reactions were mild. The incidence of a MACE was similar in both groups [1 (0.6%) ioxaglate versus 2 (1.6%) iopromide, p=0.579]. The incidence of allergic reactions was similar if ioxaglate was used alone or in combination with iopromide (p=0.478). CONCLUSIONS: Whilst combining ionic and non-ionic contrast agents in the same procedure was not associated with any more adverse reactions than using an ionic contrast agent alone, the ionic contrast agent ioxaglate was associated with the majority of allergic reactions. With respect to choice of contrast agent, using the non-ionic agent iopromide alone for coronary intervention is associated with the lowest risk of an adverse event.

Comparison of 6 and 7 French guiding catheters for percutaneous coronary intervention: results of a randomised trial with a vascular ultrasound endpoint.

OBJECTIVE: To perform a randomized, ultrasound controlled trial to define the procedural and clinical advantages and limitations of 6 French (Fr) compared with 7 Fr transfemoral coronary intervention in the stenting era. BACKGROUND: The use of 7 Fr guiding catheters may facilitate Percutaneous Coronary Intervention (PCI), but may be associated with increased vascular complications when compared with 6 Fr catheters. METHODS: Patients undergoing PCI considered suitable for either a 6 or 7 Fr sheath and guiding catheter system were included. All vascular sheaths were removed with assisted manual compression. Femoral vascular ultrasounds were performed prior to hospital discharge and interpreted by a vascular surgeon blinded to treatment assignment. The primary endpoint was a composite of significant vascular complications including major haematoma, retroperitoneal haematoma, pseudoaneurysm, arterio-venous fistula, or femoral venous or arterial thrombosis. RESULTS: During the study, 414 patients (mean age 61+/-11 years, 27% females) were randomly assigned to 6 Fr or 7 Fr sheath groups. The incidence of major vascular complications was 5.7% in the 6 Fr group and 3.9% in the 7 Fr group (P=0.383). There was no significant difference in procedural or angiographic success between the groups. The use of contrast volume was higher in the 7 Fr group (157+/-58 ml vs. 144+/-58 ml; P=0.029). There was a trend toward better operator satisfaction with the 7 Fr guide (P=0.08). CONCLUSIONS: This prospective, randomized trial indicates no reduction in major peripheral vascular complications with the use of smaller guiding catheters in PCI. There was less contrast used in the 6 Fr group, which may benefit some patient subsets, however operators tended to prefer the larger 7 Fr system. The target coronary anatomy and need for complex device intervention should mandate the choice of guiding catheter size, not a perceived impact on vascular complications.

Patient tolerance and resource utilization associated with an arterial closure versus an external compression device after percutaneous coronary intervention.

We assessed patient tolerance and resource utilization of using the AngioSeal closure device versus assisted manual compression using the Femostop device after percutaneous coronary intervention (PCI). Patients undergoing PCI with clean arterial access and no procedural hematoma were randomized to receive the AngioSeal or Femostop device to achieve femoral arterial hemostasis. Times from procedure end to removal from angiography table, hemostasis, ambulation, and hospital discharge were recorded. Bedside nursing/medical officer care time, vascular complications, and disposable use were also documented. Patient comfort was assessed using Present Pain Intensity and Visual Analogue scales at baseline, 4 hr, 8 hr, and the morning after the procedure. One hundred twenty-two patients were enrolled (62 AngioSeal, 60 Femostop). Patients in the AngioSeal group took longer to be removed from the angiography table (11 +/- 4 vs. 9 +/- 3 min; P = 0.002) compared with the Femostop group. Time to hemostasis (0.4 +/- 1.1 vs. 6.4 +/- 1.7 hr; P < 0.001) and ambulation (17 +/- 8 vs. 22 +/- 13 hr; P = 0.004) were less in the AngioSeal group, although time to discharge was not different. Nursing and medical officer time was no different. Disposables including device cost were higher in the AngioSeal group (209 dollars +/- 13 vs. 53 dollars +/- 9; P < 0.001). On a Visual Analogue scale, patients reported more pain at 4 hr (P < 0.001) and 8 hr (P < 0.001) in the Femostop group. The worst amount of pain at any time point was also more severe in the Femostop group (P < 0.001). Similar results were found on a Present Pain Intensity scale of pain. There were no differences in ultrasound-determined vascular complications (two each). Femoral access site closure using the AngioSeal device resulted in a small delay in leaving the angiography suite and a higher disposable cost compared to using the Femostop device. However, patients receiving the AngioSeal were able to ambulate sooner and reported less pain, which may justify the increased costs involved.

A randomized comparison of clopidogrel and aspirin versus ticlopidine and aspirin after coronary stent implantation.

BACKGROUND: The combination of a thienopyridine and aspirin has become the standard of care after intracoronary stenting. Clopidogrel appears to be better tolerated than ticlopidine but may be associated with more adverse cardiac events. We assessed the tolerability and efficacy of 2 weeks of therapy with ticlopidine and aspirin in comparison to clopidogrel and aspirin after coronary stent implantation. METHODS: Patients with successful intracoronary stent implantation at our institution were randomly assigned, in addition to aspirin, to receive either ticlopidine or clopidogrel. Loading doses were administered immediately after the procedure, and the drugs were continued for 2 weeks. RESULTS: Three hundred seven patients were randomly assigned: 154 patients to clopidogrel and 153 to the ticlopidine group. The primary end point of early drug discontinuation occurred in 5 patients (3.3%) in the ticlopidine group and 1 patient (0.6%) in the clopidogrel group (P =.121). Within 30 days, thrombotic stent occlusion occurred in 1 patient (0.7%) in the ticlopidine group and 3 patients (1.9%) in the clopidogrel group (P =.623). A major adverse cardiac event occurred in 3 patients (approximately 1.9%; P = 1.00) in each group. CONCLUSIONS: There was a nonsignificant trend to improved tolerability of a 2-week regimen of clopidogrel and aspirin when compared with ticlopidine and aspirin in patients undergoing intracoronary stent implantation. The combination of clopidogrel and aspirin results in a comparably low incidence of major adverse cardiac events when compared with ticlopidine and aspirin.

Compensatory changes in atrial volumes with normal aging: is atrial enlargement inevitable?

OBJECTIVES: The aim of this study was to evaluate left atrial volume and its changes with the phases (active and passive) of atrial filling, and to examine the effect of normal aging on these parameters and pulmonary vein (PV) flow patterns. BACKGROUND: Atrial volume change with normal aging has not been adequately described. Pulmonary vein flow patterns have not been volumetrically evaluated in normal aging. Combining atrial volumes and PV flow patterns obtained using transthoracic echocardiography could estimate shifts in left atrial mechanical function with normal aging. METHODS: A total of 92 healthy subjects, divided into two groups: Group Y (young <50 years) and Group O (old > or =50 years), were prospectively studied. Maximal (Vol(max)) and minimal (Vol(min)) left atrial volumes were measured using the biplane method of discs and by three-dimensional echocardiographic reconstruction using the cubic spline interpolation algorithm. The passive filling, conduit, and active emptying volumes were also estimated. Traditional measures of atrial function, mitral peak A-wave velocity, velocity time integral (VTI), atrial emptying fraction, and atrial ejection force were measured. RESULTS: As age increased, Vol(max), Vol(min), and total atrial contribution to left ventricle (LV) stroke volume were not significantly altered. However, the passive emptying volume was significantly higher (14.2 +/- 6.4 ml vs. 11.6 +/- 5.7 ml; p = 0.03) whereas the active emptying volume was lower (8.6 +/- 3.7 ml vs. 10.2 +/- 3.8 ml; p = 0.04) in Group Y versus Group O. Pulmonary vein flow demonstrated an increase in peak diastolic velocity (Group Y vs. Group O) with no corresponding change in diastolic VTI or systolic fraction. CONCLUSIONS: Normal aging does not increase maximum (end-systolic) atrial size. The atrium compensates for changes in LV diastolic properties by augmenting active atrial contraction. Pulmonary vein flow patterns, although diastolic dominant using peak velocity, demonstrated no volumetric change with aging.