Long-Term Results of the RAPCO Trials.

BACKGROUND: An internal thoracic artery graft to the left anterior descending artery is standard in coronary bypass surgery, but controversy exists on the best second conduit. The RAPCO trials (Radial Artery Patency and Clinical Outcomes) were designed to compare the long-term patency of the radial artery (RA) with that of the right internal thoracic artery (RITA) and the saphenous vein (SV). METHODS: In RAPCO-RITA (the RITA versus RA arm of the RAPCO trial), 394 patients <70 years of age (or <60 years of age if they had diabetes mellitus) were randomized to receive RA or free RITA graft on the second most important coronary target. In RAPCO-SV (the SV versus RA arm of the RAPCO trial), 225 patients ≥70 years of age (or ≥60 years of age if they had diabetes mellitus) were randomized to receive RA or SV graft. The primary outcome was 10-year graft failure. Long-term mortality was a nonpowered coprimary end point. The main analysis was by intention to treat. RESULTS: In the RA versus RITA comparison, the estimated 10-year patency was 89% for RA versus 80% for free RITA (hazard ratio for graft failure, 0.45 [95% CI, 0.23-0.88]). Ten-year patient survival estimate was 90.9% in the RA arm versus 83.7% in the RITA arm (hazard ratio for mortality, 0.53 [95% CI, 0.30-0.95]). In the RA versus SV comparison, the estimated 10-year patency was 85% for the RA versus 71% for the SV (hazard ratio for graft failure, 0.40 [95% CI, 0.15-1.00]), and 10-year patient survival estimate was 72.6% for the RA group versus 65.2% for the SV group (hazard ratio for mortality, 0.76 [95% CI, 0.47-1.22]). CONCLUSIONS: The 10-year patency rate of the RA is significantly higher than that of the free RITA and better than that of the SV. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00475488.

Radial-Artery or Saphenous-Vein Grafts in Coronary-Artery Bypass Surgery.

BACKGROUND: The use of radial-artery grafts for coronary-artery bypass grafting (CABG) may result in better postoperative outcomes than the use of saphenous-vein grafts. However, randomized, controlled trials comparing radial-artery grafts and saphenous-vein grafts have been individually underpowered to detect differences in clinical outcomes. We performed a patient-level combined analysis of randomized, controlled trials to compare radial-artery grafts and saphenous-vein grafts for CABG. METHODS: Six trials were identified. The primary outcome was a composite of death, myocardial infarction, or repeat revascularization. The secondary outcome was graft patency on follow-up angiography. Mixed-effects Cox regression models were used to estimate the treatment effect on the outcomes. RESULTS: A total of 1036 patients were included in the analysis (534 patients with radial-artery grafts and 502 patients with saphenous-vein grafts). After a mean (±SD) follow-up time of 60±30 months, the incidence of adverse cardiac events was significantly lower in association with radial-artery grafts than with saphenous-vein grafts (hazard ratio, 0.67; 95% confidence interval [CI], 0.49 to 0.90; P=0.01). At follow-up angiography (mean follow-up, 50±30 months), the use of radial-artery grafts was also associated with a significantly lower risk of occlusion (hazard ratio, 0.44; 95% CI, 0.28 to 0.70; P<0.001). As compared with the use of saphenous-vein grafts, the use of radial-artery grafts was associated with a nominally lower incidence of myocardial infarction (hazard ratio, 0.72; 95% CI, 0.53 to 0.99; P=0.04) and a lower incidence of repeat revascularization (hazard ratio, 0.50; 95% CI, 0.40 to 0.63; P<0.001) but not a lower incidence of death from any cause (hazard ratio, 0.90; 95% CI, 0.59 to 1.41; P=0.68). CONCLUSIONS: As compared with the use of saphenous-vein grafts, the use of radial-artery grafts for CABG resulted in a lower rate of adverse cardiac events and a higher rate of patency at 5 years of follow-up. (Funded by Weill Cornell Medicine and others.).

Association of Radial Artery Graft vs Saphenous Vein Graft With Long-term Cardiovascular Outcomes Among Patients Undergoing Coronary Artery Bypass Grafting: A Systematic Review and Meta-analysis.

Importance: Observational studies have suggested that the use of radial artery grafts for coronary artery bypass grafting may improve clinical outcomes compared with the use of saphenous vein grafts, but this has not been confirmed in randomized trials. Objective: To compare clinical outcomes between patients receiving radial artery vs saphenous vein grafts for coronary artery bypass grafting after long-term follow-up. Design, Setting, and Participants: Patient-level pooled analysis comparing radial artery vs saphenous vein graft in adult patients undergoing isolated coronary artery bypass grafting from 5 countries (Australia, Italy, Serbia, South Korea, and the United Kingdom), with enrollment from 1997 to 2009 and follow-up completed in 2019. Interventions: Patients were randomized to undergo either radial artery (n = 534) or saphenous vein (n = 502) grafts for coronary artery bypass grafting. Main Outcomes and Measures: The primary outcome was a composite of death, myocardial infarction, or repeat revascularization and the secondary outcome was a composite of death or myocardial infarction. Results: A total of 1036 patients were randomized (mean age, 66.6 years in the radial artery group vs 67.1 years in the saphenous vein group; 376 [70.4%] men in the radial artery group vs 351 [69.9%] in the saphenous vein group); 942 (90.9%) of the originally randomized patients completed 10 years of follow-up (510 in the radial artery group). At a median (interquartile range) follow-up of 10 (10-11) years, the use of the radial artery, compared with the saphenous vein, in coronary artery bypass grafting was associated with a statistically significant reduction in the incidence of the composite outcome of death, myocardial infarction, or repeat revascularization (220 vs 237 total events; 41 vs 47 events per 1000 patient-years; hazard ratio, 0.73 [95% CI, 0.61-0.88]; P < .001) and of the composite of death or myocardial infarction (188 vs 193 total events; 35 vs 38 events per 1000 patient-years; hazard ratio, 0.77 [95% CI, 0.63-0.94]; P = .01). Conclusions and Relevance: In this individual participant data meta-analysis with a median follow-up of 10 years, among patients undergoing coronary artery bypass grafting, the use of the radial artery compared with the saphenous vein was associated with a lower risk of a composite of cardiovascular outcomes.

Two Long-Term Mortality Risk Models For Coronary Artery Bypass Graft Surgery Produced in American Populations Validated in an Australian Population.

BACKGROUND: Short-term mortality prediction models have an important role in current cardiac surgical practice. There has been much less attention paid to prediction of long-term outcomes which are probably an equal marker both of surgeon performance and appropriateness of surgical treatment. The aim of this study was to assess the performance of the New York State Cardiac Surgery Reporting System (NYSCSRS) risk model and the Northern New England Cardiovascular Disease Study Group (NNECDSG) risk model on the Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) patient database. METHODS: The NYSCSRS and the NNECDSG risk models were applied to all patients undergoing isolated coronary artery bypass graft (CABG) surgery that had complete data, were over the age of 18 and had a body mass index between 12 and 78 kg/m2. Predicted mortality was calculated using the published risk model formulae and compared with observed mortality, obtained via linkage with the National Death Index, at four time-points (one, three, five and seven years following surgery). Model discrimination and model calibration were tested at all four time points by determining the C-statistics for receiver operator characteristic (ROC) curves, and studying the Hosmer-Lemeshow chi-square tests, respectively. RESULTS: The NYSCSRS and NNECDSG risk models were applied to 34,961 and 34,998 patients, respectively. The NYSCSRS risk model over-predicted mortality by between 130% and 216% at all four time-points while the NNECDSG risk model under-predicted mortality at one year by 4.3% but over-predicted mortality at three, five and seven years by between 42.5% and 145.7%. The C-statistics obtained fell between 0.779 and 0.741 for the NYSCSRS risk model and between 0.785 and 0.752 for the NNECDSG risk model at all four time-points. Hosmer-Lemeshow chi-square tests returned p-values <0.001 at all four time-points for both risk models. CONCLUSION: The NYSCSRS and NNECDSG risk models do not accurately predict long-term mortality following isolated CABG surgery in the ANZSCTS patient population. The use of either of these risk models is not appropriate in Australia.

Impact of Discontinuation of Antiplatelet Therapy Prior to Isolated Valve and Combined Coronary Artery Bypass Graft and Valve Procedures on Short and Intermediate Term Outcomes.

BACKGROUND: A change in cardiac surgery practice over the past decade has seen an increase in urgent or inpatient referrals for surgery, with antiplatelet therapy often continued up until surgery. This study aims to identify the optimal timing for administration of aspirin to minimise risk of perioperative morbidity and mortality. METHODS: From a prospectively compiled database collected by the Australian and New Zealand Society of Cardiac and Thoracic Surgeons, we identified 8294 patients undertaking combined CABG and valve or isolated valve procedures while discontinuing aspirin. Time points for cessation of antiplatelet therapy were categorised as follows: <2 days, 3-7 days or >7 days preoperatively. We evaluated the association of adverse in-hospital events and intermediate term survival in each time category. RESULTS: Discontinuing aspirin 3 to 7 days from surgery decreased rates of perioperative MI (HR=0.300, p=0.027), return to theatre (HR=0.560, p=0.002) reduced drain output (HR=0.757, p=0.000) and red blood cell and platelet transfusions (HR=0.719, p=0.000 and HR=0.604, p=0.000 respectively) compared to patients continuing aspirin until <2 days from the procedure. Stopping aspirin <2 days from the date of surgery increased risk of perioperative MI (HR=5.919, p=0.000), reoperation for bleeding (HR=2.076, p=0.001), returning to theatre (HR=1.781, p=0.000), ICC drain losses (HR=1.337, p=0.000) and transfusion demands for red blood cells (HR=1.381, p=0.000) and platelets (HR=1.450, p=0.000) when compared to those discontinuing aspirin >7 days from surgery. CONCLUSION: Late discontinuation of aspirin before combined coronary artery bypass graft and valve procedures results in greater rates of bleeding and transfusion requirements. Earlier discontinuation of aspirin results in no benefit in intermediate term survival.

Apneic Oxygenation Versus Low-Tidal-Volume Ventilation in Anesthetized Cardiac Surgical Patients: A Prospective, Single-Center, Randomized Controlled Trial.

OBJECTIVES: To compare the physiology of apneic oxygenation with low-tidal-volume (VT) ventilation during harvesting of the left internal mammary artery. DESIGN: Prospective, single-center, randomized trial. SETTING: Single-center teaching hospital. PARTICIPANTS: The study comprised 24 patients who underwent elective coronary artery bypass grafting surgery. INTERVENTIONS: Apneic oxygenation (apneic group: 12 participants) and low-VT ventilation (low-VT group: 12 participants) (2.5 mL/kg ideal body weight) for 15 minutes during harvesting of the left internal mammary artery. MEASUREMENT AND MAIN RESULTS: The primary endpoint was an absolute change in partial pressure of arterial carbon dioxide (PaCO2). Secondary endpoints were changes in arterial pH, pulmonary artery pressures (PAP), cardiac index, and pulmonary artery acceleration time and ease of surgical access. The mean (standard deviation) absolute increase in PaCO2 was 31.8 mmHg (7.6) in the apneic group and 17.6 mmHg (8.2) in the low-VT group (baseline-adjusted difference 14.2 mmHg [95% confidence interval 21.0-7.3], p<0.001). The mean (standard deviation) absolute decrease in pH was 0.15 (0.03) in the apneic group and 0.09 (0.03) in the low-VT group baseline-adjusted difference 0.06 [95% confidence interval 0.03-0.09], p<0.001. Differences in the rate of change over time between groups (time-by-treatment interaction) were observed for PaCO2 (p<0.001), pH (p<0.001), systolic PAP (p = 0.002), diastolic PAP (p = 0.023), and mean PAP (p = 0.034). Both techniques provided adequate ease of surgical access; however, apneic oxygenation was preferred predominantly. CONCLUSIONS: Apneic oxygenation caused a greater degree of hypercarbia and respiratory acidemia compared with low-VT ventilation. Neither technique had deleterious effects on PAP or cardiac function. Both techniques provided adequate ease of surgical access.

Neutrophil gelatinase-associated lipocalin after off pump versus on pump coronary artery surgery.

CONTEXT: Cardiac surgery. OBJECTIVE: To compare plasma and urinary neutrophil gelatinase-associated lipocalin (P-/U-NGAL) in on-pump (n = 43) versus off-pump (n = 40) surgery. MATERIALS AND METHODS: We obtained perioperative P-/U-NGAL and outcome data. RESULTS: P-/U-NGAL increased after surgery. P-NGAL was higher post-surgery in on pump patients (139 versus 67 µg L(-1); p < 0.001), but not at 24 h. There were no differences in U-NGAL. Correlation between P-/U-NGAL and plasma creatinine was weak. DISCUSSION: P-NGAL acts like a neutrophil activation biomarker and U-NGAL like a tubular injury marker. CONCLUSION: On-pump patients had greater neutrophil activation. On- versus off-pump surgery had similar impact on tubular cells.

Impact of socioeconomic status and rurality on early outcomes and mid-term survival after CABG: insights from a multicentre registry.

BACKGROUND: We examined whether socioeconomic status and rurality influenced outcomes after coronary surgery. METHODS: We identified 14,150 patients undergoing isolated coronary surgery. Socioeconomic and rurality data was obtained from the Australian Bureau of Statistics and linked to patients' postcodes. Outcomes were compared between categories of socioeconomic disadvantage (highest versus lowest quintiles, n= 3150 vs. 2469) and rurality (major cities vs. remote, n=9598 vs. 839). RESULTS: Patients from socioeconomically-disadvantaged areas experienced a greater burden of cardiovascular risk factors including diabetes, obesity and current smoking. Thirty-day mortality (disadvantaged 1.6% vs. advantaged 1.6%, p>0.99) was similar between groups as was late survival (7 years: 83±0.9% vs. 84±1.0%, p=0.79). Those from major cities were less likely to undergo urgent surgery. There was similar 30-day mortality (major cities: 1.6% vs. remote: 1.5%, p=0.89). Patients from major cities experienced improved survival at seven years (84±0.5% vs. 79±2.0%, p=0.010). Propensity-analysis did not show socioeconomic status or rurality to be associated with late outcomes. CONCLUSION: Patients presenting for coronary artery surgery from different socioeconomic and geographic backgrounds exhibit differences in their clinical profile. Patients from more rural and remote areas appear to experience poorer long-term survival, though this may be partially driven by the population's clinical profile.

Unusual Location of a Papillary Fibroelastoma Causing a Multi-territorial Stroke.

A 56-year-old male presented with a multi-territorial stroke without traditional cerebrovascular risk factors. A transesophageal echocardiogram revealed an intracardiac lesion attached to the lateral wall of the left atria, consistent with an atrial myxoma. Surgical excision of the lesion was performed and revealed that lesion was in fact a papillary fibroelastoma with thrombus attached, which demonstrates a novel mechanism by which intracardiac masses can cause cerebral events.

Lipid management in high risk coronary patients: how effective are we at secondary intervention?

OBJECTIVE: To assess the proportion of patients who achieve and maintain target lipid levels during optimum long term follow up after coronary bypass surgery. METHODS: From a prospectively compiled database, we identified 440 patients followed for up to 13 years after CABG as part of a radial artery randomised controlled trial. All available lipid assays conducted during the follow-up period were collected from pathology databases. These were used to calculate the annualised mean lipid exposure for each patient. Based upon National Heart Foundation guidelines, we determined the proportion of patients whose mean lipid exposure attained target levels (total cholesterol <4.0 mmol/L, LDL-C <2.0 mmol/L, HDL-C >1.0 mmol/L and triglycerides <1.5 mmol/L). This was compared with the proportion who had achieved these targets pre-operatively and on their most recent cholesterol measurement. RESULTS: 6077 lipid studies (total cholesterol, LDL, HDL and triglycerides) in total were obtained. In those who had baseline data available, target levels for total cholesterol, HDL-C, LDL-C and triglycerides were attained pre-operatively by 16%, 64%, 14% and 39% of patients respectively. Annualised mean lipid exposures during up to 13 years of follow up for all patients revealed somewhat improved but still suboptimal target attainment figures of 24%, 83%, 20% and 53%. The most recent review shows the greatest improvement at 47%, 68%, 43% and 62% respectively. Of 141 diabetic patients, target attainment was significantly higher for total cholesterol (31%; p=0.038) and LDL-C (28%; p=0.006) but lower for HDL-C (75%; p=0.002) and triglycerides (40%; p<0.001). CONCLUSION: Despite some improvements seen over careful follow up, only HDL-C targets appear attainable for the majority of CABG patients. Over half still do not achieve non-HDL national lipid targets.

The Radial Artery Patency and Clinical Outcomes trial: design, intermediate term results and future direction.

The Radial Artery Patency and Clinical Outcomes Study (RAPCO) was devised and implemented in Melbourne in order to establish the appropriate place of the radial artery in the hierarchy of conduits available to the modern coronary bypass surgeon. Designed as a biological comparison with minimisation of other confounding variables, it compares this free arterial graft with the right internal thoracic artery and saphenous vein, with all conduits used in an identical fashion in two parallel cohorts of different age ranges. Enrolment was completed in 2004 and 10-year follow-up is in progress, with mean duration of about seven years at present. The midterm clinical and angiographic results to date are reviewed here, but definitive conclusions will not be possible until full completion angiographic data is available. The trial data provides a number of potential substudies of conduits, risk factors for failure and the natural history of treated coronary disease.

Impact of chronic kidney disease on patient outcome following cardiac surgery.

BACKGROUND: Renal impairment is a major risk factor for cardiovascular disease. This study addressed clinical predictors of outcome following cardiac surgery, focusing on pre-operative renal dysfunction. METHODS: All patients undergoing cardiac surgery at Austin Health from June 1, 2001 to June 30, 2006, were included in the analysis. Logistic regression models were used to evaluate clinical factors predicting "operative mortality" and common post-operative complications. RESULTS: The operative mortality was 1.36% for coronary artery bypass grafting (CABG) alone (n=1027), 5.07% for valve surgery alone (n=217), 4.43% for combined CABG and valve surgery (n=158) and 11.11% for other cardiac surgical procedures (n=270). Amongst CABG alone patients, pre-operative renal impairment was a strong predictor of operative mortality, with a 35-43% increased risk of death (p=0.005) for every 10 ml/min/1.73 m(2) that the glomerular filtration rate was lower. Peripheral vascular disease, recent myocardial infarction and congestive cardiac failure also predicted operative mortality. Pre-operative renal impairment also increased the rate of various post-operative complications, as well as duration of admission. CONCLUSION: Renal dysfunction is significantly associated with increased mortality and morbidity following cardiac surgery and necessitates careful consideration in risk benefit analysis when considering cardiac surgery.

Angiographic Outcome of Coronary Artery Bypass Grafts: The Radial Artery Database International Alliance.

BACKGROUND: We used a large patient-level data set including 6 angiographic randomized controlled trials (RCTs) on coronary artery bypass conduits to explore incidence and determinants of coronary graft failure. METHODS: Patient-level angiographic data of 6 RCTs comparing long-term outcomes of the radial artery and other conduits were joined. Primary outcome was graft occlusion at maximum follow-up. The analysis was divided as (1) left anterior descending coronary (LAD) distribution and (2) non-LAD distribution (circumflex and right coronary artery). Mixed-model multivariable Cox regression including all baseline characteristics with stratification by individual trials was used to identify predictors of graft occlusion. RESULTS: Included were 1091 patients and 2281 grafts, consisting of 921 left internal mammary arteries, 74 right internal mammary arteries, 710 radial arteries, and 576 saphenous veins. All left internal mammary arteries were used on the LAD, the other conduits were used on the non-LAD distribution. Mean angiographic follow up was 65 ± 29 months. Occlusion rates were 2.3% for the left internal mammary arteries, 13.5% for the left internal mammary arteries, 9.4% for the right internal mammary arteries, and 17.5% for the saphenous veins. At multivariable analysis, type of conduit used, age, female sex, left ventricular ejection fraction of less than 0.50, and use of the Y graft were significantly associated with graft occlusion in the non-LAD distribution. CONCLUSIONS: Our analyses showed that failure of the left internal mammary arteries-to-LAD bypass is a very uncommon event. For the non-LAD distribution, the nonuse of radial artery, age, female sex, left ventricular ejection fraction of less than 0.50, and use of the Y graft configuration were significantly associated with midterm graft failure.

Mitral and tricuspid valve repair in hypereosinophilic syndrome.

Hypereosinophilic syndrome (HES) is a rare systemic condition, defined as a persistently elevated eosinophil count associated with end organ damage and the absence of a primary cause. Cardiac involvement occurs in about 50% of patients with HES. Myocardial infiltration results in endomyocardial fibrosis, valve dysfunction and mural thrombus. The atrioventricular valves are almost always involved, resulting in regurgitation due to leaflet restriction, most commonly affecting the posterior mitral valve leaflet. Surgical management remains challenging in patients with HES with limited data on the choice of valve surgery. We describe the case of a 17-year-old woman with HES complicated by congestive cardiac failure secondary to severe mitral and tricuspid regurgitation. Because of refractory heart failure despite medical therapy, surgical mitral and tricuspid valve repair was performed, and an excellent 24-month outcome was achieved. We believe this is the first report of double valve repair in this rare condition.

Effect of Calcium-Channel Blocker Therapy on Radial Artery Grafts After Coronary Bypass Surgery.

BACKGROUND: Few studies have evaluated the effect of chronic calcium-channel blocker therapy (CCB) on the angiographic and clinical outcome of radial artery (RA) grafts used for coronary bypass surgery. OBJECTIVES: The purpose of this study was to evaluate if CCB influences midterm clinical and angiographic outcomes of RA grafts. METHODS: Patient-level data of 6 angiographic randomized trials evaluating RA graft status at midterm follow-up were joined in this observational analysis. Cox regression and propensity score methods were used to evaluate the effect of CCB on the incidence of a composite of major adverse cardiac events (MACE) (death, myocardial infarction, and repeat revascularization) and graft occlusion. RESULTS: The study population included 732 patients (502 on CCB). The median clinical follow-up was 60 months. The cumulative incidence of MACE at 36, 72, and 108 months was 3.7% vs. 9.3%, 13.4% vs. 17.6%, and 16.8% vs. 20.5% in the CCB and no CCB groups, respectively (log-rank p = 0.003). Protocol-driven angiographic follow-up was available in 243 patients in the CCB group and 200 in the no CCB group. The median angiographic follow-up was 55 months. The cumulative incidence of RA occlusion at 36, 72, and 108 months was 0.9% vs. 8.6%, 9.6% vs. 21.4%, and 14.3% vs. 38.9% in the CCB and no CCB groups, respectively (log-rank p < 0.001). After controlling for known confounding, CCB therapy was found to be consistently associated with a significantly lower risk of MACE (multivariate Cox hazard ratio: 0.52; 95% confidence interval: 0.31 to 0.89; p = 0.02) and RA graft occlusion (multivariate Cox hazard ratio: 0.20; 95% confidence interval: 0.08 to 0.49; p < 0.001). CONCLUSIONS: In patients with RA grafts CCB is associated with significantly better midterm clinical and angiographic RA outcomes.

The RADial artery International ALliance (RADIAL) extended follow-up study: rationale and study protocol.

It is generally accepted that radial artery (RA) grafts have better mid-term patency rate compared to saphenous vein grafts. However, the clinical correlates of the improved patency rate are still debated. Observational studies have suggested increased survival and event-free survival for patients who receive an RA rather than a saphenous vein, but they are open to bias and confounders. The only evidence based on randomized data is a pooled meta-analysis of 6 randomized controlled trial comparing the RA and the saphenous vein published by the RADial artery International Alliance (RADIAL). In the RADIAL database, improved freedom from follow-up cardiac events (death, myocardial infarction and repeat revascularization) was found at 5-year follow-up in the RA arm. The most important limitation of the RADIAL analysis is that most of the included trials had an angiographic follow-up in the first 5 years and it is unclear whether the rate of repeat revascularization (the main driver of the composite outcome) was clinically indicated due to per-protocol angiographies. Here, we present the protocol for the long-term analysis of the RADIAL database. By extending the follow-up beyond the 5th postoperative year (all trials except 1 did not have angiographic follow-up beyond 5 years), we aim to provide data on the role of RA in coronary artery bypass surgery with respect to long-term outcomes.

Effect of radial artery or saphenous vein conduit for the second graft on 6-year clinical outcome after coronary artery bypass grafting. Results of a randomised trial.

OBJECTIVES: In order to determine the best conduit for coronary targets other than the left anterior descending (LAD) artery, long-term clinical outcomes following revascularisation with a radial artery or saphenous vein graft were evaluated as part of the radial artery patency and clinical outcomes (RAPCO) study. METHODS: As part of the RAPCO protocol for this prospective, randomised, single-centre trial, patients aged over 70 years undergoing primary CABG were randomly assigned to use of a radial artery (n=113) or saphenous vein (n=112) to revascularise the best non-LAD coronary vessel. Follow-up was annual. Primary clinical end-points were death, myocardial infarction or need for revascularisation. Data were analysed by intention to treat. RESULTS: The preoperative demographics (age, gender, presence of hypertension or diabetes mellitus) and urgency of surgery did not differ significantly between the two groups. The allocated arterial or venous conduit was utilised as intended in 104/113 and 110/112 patients, respectively. Mean number of grafts was 3.2+/-0.9 and 3.3+/-0.7 in the two groups. During follow-up of mean duration 6.2 years (maximum 10.8 years) there were 16 deaths in each group and 9 vs 13 other events in the radial artery and saphenous vein groups, respectively. These clinical outcomes did not differ significantly (log rank p=0.98 for survival and p=0.52 for event-free survival). CONCLUSIONS: Use of a radial artery or saphenous vein for the second graft during primary CABG does not significantly influence clinical outcome at 6 years. Mean 5-year angiographic patency data are awaited, but from the patient's perspective the likelihood of a satisfactory long-term result is equivalent, whichever conduit is used.

Biopharmaceutics data management system for anonymised data sharing and curation: First application with orbito IMI project.

The OrBiTo IMI project was designed to improve the understanding and modelling of how drugs are absorbed. To achieve this 13 pharmaceutical companies agreed to share biopharmaceutics drug properties and performance data, as long as they were able to hide certain aspects of their dataset if required. This data was then used in simulations to test how three in silico Physiological Based Pharmacokinetic (PBPK) tools performed. A unique database system was designed and implemented to store the drug data. The database system was unique, in that it had the ability to make different sections of a dataset visible or hidden depending on the stage of the project. Users were also given the option to hide identifying API attributes, to help prevent identification of project members from previously published data. This was achieved by applying blinding strategies to data parameters and the adoption of a unique numbering system. An anonymous communication tool was proposed to exchange comments about data, which enabled its curation and evolution. This paper describes the strategy adopted for numbering and blinding of the data, the tools developed to gather and search data as well as the tools used for communicating around the data with the aim of publicising the approach for other pre-competitive research between organisations.

The effects on coagulation of the reinfusion of unprocessed residual blood from the cardiopulmonary bypass.

BACKGROUND: Autologous blood transfusion is a common technique in cardiac surgery to directly re-infuse residual blood from the cardiopulmonary bypass (CPB) circuit to the patient. The objective of this study was to evaluate the effects of reinfusion of unprocessed residual pump blood on the coagulation system after separation from the CPB circuit and reversal of systemic heparin with protamine. MEASUREMENTS AND MAIN RESULTS: After ethics approval, 40 participants undergoing cardiac surgery were recruited in a prospective single center cohort study. Changes in coagulation were assessed with standard plasma based laboratory assays and thromboelastography. After the reinfusion of unprocessed residual pump blood there were decreases in the mean aPTT (effect size 6 s; SD: 6.05; p < 0.0001) and thrombin time (effect size 4.08 s; SD: 9.7; p = 0.01). There were no significant changes in PT, INR and D-dimer. Post reinfusion there were increases in fibrinogen, hemoglobin and platelet counts. There were improvements in the R-time (effect size 9.1 s; SD: 16.9; p = 0.0023), K-time (effect size 1.5 s; SD: 3.6 s; p = 0.0017), alpha angle (6.9°; SD: 15.8; p = 0.012), and maximum amplitude (3.0 mm; SD: 5.6, p = 0.002) on thromboelastography. CONCLUSION: The reinfusion of unprocessed residual CPB blood resulted in no deleterious effects on the coagulation system measured by both the common laboratory plasma based measurements of coagulation and thromboelastography.