Anticoagulation for post-operative atrial fibrillation after isolated coronary artery bypass grafting: a meta-analysis.

BACKGROUND AND AIMS: This study aimed to evaluate clinical outcomes in patients developing post-operative atrial fibrillation (POAF) after coronary artery bypass grafting (CABG) and characterize variations in oral anticoagulation (OAC) use, benefits, and complications. METHODS: A systematic search identified studies on new-onset POAF after CABG and OAC initiation. Outcomes included risks of thromboembolic events, bleeding, and mortality. Furthermore, a meta-analysis was conducted on these outcomes, stratified by the use or non-use of OAC. RESULTS: The identified studies were all non-randomized. Among 1 698 307 CABG patients, POAF incidence ranged from 7.9% to 37.6%. Of all POAF patients, 15.5% received OAC. Within 30 days, thromboembolic events occurred at rates of 1.0% (POAF: 0.3%; non-POAF: 0.8%) with 2.0% mortality (POAF: 1.0%; non-POAF: 0.5%). Bleeding rates were 1.1% for POAF patients and 2.7% for non-POAF patients. Over a median of 4.6 years, POAF patients had 1.73 thromboembolic events, 3.39 mortality, and 2.00 bleeding events per 100 person-years; non-POAF patients had 1.14, 2.19, and 1.60, respectively. No significant differences in thromboembolic risks [effect size -0.11 (-0.36 to 0.13)] and mortality [effect size -0.07 (-0.21 to 0.07)] were observed between OAC users and non-users. However, OAC use was associated with higher bleeding risk [effect size 0.32 (0.06-0.58)]. CONCLUSIONS: In multiple timeframes following CABG, the incidence of complications in patients who develop POAF is low. The use of OAC in patients with POAF after CABG is associated with increased bleeding risk.

First-time surgical aortic valve replacement: nationwide trends and outcomes from The Netherlands Heart Registration.

OBJECTIVES: The aim of this study was to describe trends and outcomes for patients undergoing surgical aortic valve replacement (SAVR) in the Netherlands. METHODS: The Netherlands Heart Registration database was used to report the number and outcomes of isolated, primary SAVR procedures performed from 2007 to 2018 in adult patients. RESULTS: A total of 17 142 procedures were included, of which 77.9% were performed using a biological prosthesis and 21.0% with a mechanical prosthesis. Median logistic EuroSCORE I decreased from 4.6 [interquartile range (IQR) 2.4-7.7] to 4.0 (IQR 2.6-6.0). The 120-day mortality decreased from 3.3% in 2007 to 0.7% in 2018. The median duration of follow-up was 76 months (IQR 53-111). Ten-year survival, when adjusted for age, EuroSCORE I and body surface area, was 72.4%, and adjusted 10-year freedom from reinvervention was 98.1%. Additional analysis for patients under the age of 60 showed no difference between patients treated with a biological or mechanical prosthesis in adjusted 10-year survival, 89.7% vs 91.9±%, respectively (P = 0.25), but a significant difference in adjusted 10-year freedom from reintervention, 90.0±% vs 95.9%, respectively (P < 0.01). CONCLUSIONS: Between 2007 and 2018, age and risk profile of patients undergoing SAVR decreased, especially for patients treated with a biological prosthesis. The 120-day mortality decreased over time. Patients undergoing SAVR nowadays have a risk of 120-day mortality of <1% and 10-year freedom from valve-related reintervention of >95%.

Dynamics in cardiac surgery: trends in population characteristics and the performance of the EuroSCORE II over time.

OBJECTIVES: The aim of this study was to investigate the performance of the EuroSCORE II over time and dynamics in values of predictors included in the model. METHODS: A cohort study was performed using data from the Netherlands Heart Registration. All cardiothoracic surgical procedures performed between 1 January 2013 and 31 December 2019 were included for analysis. Performance of the EuroSCORE II was assessed across 3-month intervals in terms of calibration and discrimination. For subgroups of major surgical procedures, performance of the EuroSCORE II was assessed across 12-month time intervals. Changes in values of individual EuroSCORE II predictors over time were assessed graphically. RESULTS: A total of 103 404 cardiothoracic surgical procedures were included. Observed mortality risk ranged between 1.9% [95% confidence interval (CI) 1.6-2.4] and 3.6% (95% CI 2.6-4.4) across 3-month intervals, while the mean predicted mortality risk ranged between 3.4% (95% CI 3.3-3.6) and 4.2% (95% CI 3.9-4.6). The corresponding observed:expected ratios ranged from 0.50 (95% CI 0.46-0.61) to 0.95 (95% CI 0.74-1.16). Discriminative performance in terms of the c-statistic ranged between 0.82 (95% CI 0.78-0.89) and 0.89 (95% CI 0.87-0.93). The EuroSCORE II consistently overestimated mortality compared to observed mortality. This finding was consistent across all major cardiothoracic surgical procedures. Distributions of values of individual predictors varied broadly across predictors over time. Most notable trends were a decrease in elective surgery from 75% to 54% and a rise in patients with no or New York Heart Association I class heart failure from 27% to 33%. CONCLUSIONS: The EuroSCORE II shows good discriminative performance, but consistently overestimates mortality risks of all types of major cardiothoracic surgical procedures in the Netherlands.

The association between preoperative multidisciplinary team care and patient outcome in frail patients undergoing cardiac surgery.

OBJECTIVE: To evaluate the influence of preoperative multidisciplinary team (MDT) care on perioperative management and outcomes of frail patients undergoing cardiac surgery. BACKGROUND: Frail patients are at increased risk for complications and poor functional outcome after cardiac surgery. In these patients, preoperative MDT care may improve outcomes. METHODS: Between 2018 and 2021, 1168 patients aged 70 years or older were scheduled for cardiac surgery, of whom 98 (8.4%) frail patients were referred for MDT care. The MDT discussed surgical risk, prehabilitation, and alternative treatment. Outcomes of MDT patients were compared with 183 frail patients (non-MDT group) from a historical study cohort (2015-2017). Inverse probability of treatment weighting was used to minimize bias from nonrandom allocation of MDT versus non-MDT care. Outcomes were severe postoperative complications, total days in hospital after 120 days, disability, and health-related quality of life after 120 days. RESULTS: This study included 281 patients (98 MDT and 183 non-MDT patients). Of the MDT patients, 67 (68%) had open surgery, 21 (21%) underwent minimally invasive procedures, and 10 (10%) received conservative treatment. In the non-MDT group, all patients had open surgery. Fourteen (14%) MDT patients experienced a severe complication versus 42 (23%) non-MDT patients (adjusted relative risk, 0.76; 95% CI, 0.51-0.99). Adjusted total days in hospital after 120 days was 8 days (interquartile range, 3-12 days) versus 11 days (interquartile range, 7-16 days) for MDT and non-MDT patients, respectively (P = .01). There was no difference in disability or health-related quality of life. CONCLUSIONS: Preoperative MDT care for frail patients undergoing cardiac surgery is associated with alterations in surgical management and with a lower risk for severe complications.

Preoperative frailty and one-year functional recovery in elderly cardiac surgery patients.

OBJECTIVE: Frailty increases risk for morbidity and mortality after cardiac surgery. Its influence on functional outcome is largely unknown. We studied the association of frailty with health-related quality of life and disability after cardiac surgery. METHODS: A prospective 2-center observational cohort of 555 patients aged 70 years or more undergoing cardiac surgery. A comprehensive frailty assessment was performed before surgery based on 11 individual assessments in physical, mental, and social domains. Frailty was defined as at least 1 positive test in each domain. The primary outcome was health-related quality of life over 1 year, and the secondary outcomes were severe in-hospital complications and disability over 1 year. Adverse functional outcome was defined as the composite of a decreased health-related quality of life and disability. RESULTS: Physical frailty was most common (91%) compared with mental (39%) or social frailty (42%). Adverse functional outcome occurred in 257 patients (46%) and consisted of decreased physical health-related quality of life in 134 (24%), decreased mental health-related quality of life in 141 (25%), and disability in 120 (22%). Frailty was more common in patients with adverse functional outcome (29%) compared with patients without adverse functional outcome (16%, P < .001). Poor mobility, malnutrition, and polypharmacy were associated with a decreased health-related quality of life over time, whereas impaired physical functioning and higher self-rated health were related to increased health-related quality of life. Disability after cardiac surgery was associated with poor mobility, polypharmacy, dependent living, living alone, and lower self-rated mental health before surgery. CONCLUSIONS: Mobility, nutrition, medication use, physical functioning, and self-rated health before surgery are associated with health-related quality of life in elderly patients 1 year after cardiac surgery.

Impact of the coronavirus disease 2019 pandemic on volume of thoracic aortic surgery on a national level.

OBJECTIVES: The aim of this study was to evaluate the effects of the coronavirus 2019 pandemic on elective and acute thoracic aortic surgery in the Netherlands. METHODS: The Netherlands Heart Registration database was used to compare the volume of elective and acute surgery on the thoracic aorta in 2019 and 2020, starting from week 11 in both years. A sub-analysis was done to assess the impact of the pandemic on high-volume and low-volume aortic centres. RESULTS: During the pandemic, the number of elective thoracic aortic operations declined by 18% [incidence rate ratio (IRR) 0.82 [0.73-0.91]; P < 0.01]. The decline in volume of elective surgery was significant in both high-volume (IRR 0.82 [0.71-0.94]; P < 0.01) and low-volume aortic centres (IRR 0.81 [0.68-0.98]; P = 0.03). The overall number of acute aortic operations during the pandemic remained similar to that in 2019 (505 vs 499; P = 0.85), but an increased share of these operations occurred at high-volume centres. The number of acute operations performed in high-volume centres increased by 20% (IRR 1.20 [1.01-1.42]; P = 0.04), while the number of acute operations performed in low-volume centres decreased by 17% (IRR 0.83 [0.69-1.00]; P = 0.04). CONCLUSIONS: The coronavirus 2019 pandemic led to a significant decrease in elective thoracic aortic surgery but did not cause a change in the volume of acute thoracic aortic surgery in the Netherlands. Moreover, the pandemic led to a centralization of care for acute thoracic aortic surgery.

Associations Between Preoperative Biomarkers and Cardiac Surgery-Associated Acute Kidney Injury in Elderly Patients: A Cohort Study.

BACKGROUND: Acute kidney injury (AKI) is associated with mortality after cardiac surgery. Novel risk factors may improve identification of patients at risk for renal injury. The authors evaluated the association between preoperative biomarkers that reflect cardiac, inflammatory, renal, and metabolic disorders and cardiac surgery-associated AKI (CSA-AKI) in elderly patients. METHODS: This was a secondary analysis of the 2-center prospective cohort study "Anesthesia Geriatric Evaluation." Twelve biomarkers were determined preoperatively in 539 patients. Primary outcome was CSA-AKI. The association between biomarkers and CSA-AKI was investigated with multivariable logistic regression analysis. Secondary outcomes were 1-year mortality and patient-reported disability and were assessed with relative risks (RR) between patients with and without CSA-AKI. RESULTS: CSA-AKI occurred in 88 (16.3%) patients and was associated with increased risk of mortality (RR, 6.70 [95% confidence interval {CI}, 3.38-13.30]) and disability (RR, 2.13 [95% CI, 1.53-2.95]). Preoperative concentrations of N-terminal pro B-type natriuretic peptide (NT-proBNP), high-sensitive C-reactive protein (hs-CRP), hemoglobin, and magnesium had the strongest association with CSA-AKI. Identification of patients with CSA-AKI improved when a biomarker panel was used (area under the curve [AUC] 0.75 [95% CI, 0.69-0.80]) compared to when only clinical risk factors were used (European System for Cardiac Operative Risk Evaluation [EuroSCORE II] AUC 0.67 [95% CI, 0.62-0.73]). CONCLUSIONS: Preoperative cardiac, inflammatory, renal, and metabolic biomarkers are associated with CSA-AKI and may improve identification of patients at risk.

Recent trends in aortic valve interventions: Data of the Netherlands heart registration.

BACKGROUND AND AIM OF THE STUDY: Transcatheter aortic valve implantation (TAVI) has evolved from bailout for inoperable patients to an alternative to surgical aortic valve replacement (SAVR) in higher-risk groups. The aim of this study is to describe these clinical trends in TAVI and SAVR in patients with aortic valve disease. METHODS: We analyzed data of the Netherlands Heart Registration (NHR) up to 2018 to explore the trends in TAVI and SAVR among 14 cardiac centers in the Netherlands. RESULTS: Between 2013 and 2017, a total of 7432 isolated SAVR and 5929 TAVI procedures have been performed. A 43.9% increase in the total number of procedures was observed, mainly due to the considerable increase in the number of TAVI procedures. In 2017, there was a decrease in the number of SAVR procedures. In the TAVI group, 30- and 120-day mortality decreased significantly from 7.2% and 10.6% in 2013 to 3.4% and 5.7% in 2017, respectively. In the SAVR group, 30- and 120-day mortality decreased from 1.7% and 2.9% in 2013 to 1.2% and 1.7% in 2017, respectively. Outcomes showed a significant decrease in vascular complications after TAVI. The risk profile of TAVI patients has changed over time. CONCLUSIONS: The recent developments in TAVI have contributed to the increasing numbers of aortic valve interventions in the Netherlands. Mortality rates after SAVR and TAVI decreased as did the rate of complications after TAVI. Furthermore, a trend towards decrease of preoperative risk was observed.

Effect of Adding Ticagrelor to Standard Aspirin on Saphenous Vein Graft Patency in Patients Undergoing Coronary Artery Bypass Grafting (POPular CABG): A Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: Approximately 15% of saphenous vein grafts (SVGs) occlude during the first year after coronary artery bypass graft surgery (CABG) despite aspirin use. The POPular CABG trial (The Effect of Ticagrelor on Saphenous Vein Graft Patency in Patients Undergoing Coronary Artery Bypass Grafting Surgery) investigated whether ticagrelor added to standard aspirin improves SVG patency at 1 year after CABG. METHODS: In this investigator-initiated, randomized, double-blind, placebo-controlled, multicenter trial, patients with ≥1 SVGs were randomly assigned (1:1) after CABG to ticagrelor or placebo added to standard aspirin (80 mg or 100 mg). The primary outcome was SVG occlusion at 1 year, assessed with coronary computed tomography angiography, in all patients that had primary outcome imaging available. A generalized estimating equation model was used to perform the primary analysis per SVG. The secondary outcome was 1-year SVG failure, which was a composite of SVG occlusion, SVG revascularization, myocardial infarction in myocardial territory supplied by a SVG, or sudden death. RESULTS: Among 499 randomly assigned patients, the mean age was 67.9±8.3 years, 87.1% were male, the indication for CABG was acute coronary syndrome in 31.3%, and 95.2% of procedures used cardiopulmonary bypass. Primary outcome imaging was available in 220 patients in the ticagrelor group and 223 patients in the placebo group. The SVG occlusion rate in the ticagrelor group was 10.5% (51 of 484 SVGs) versus 9.1% in the placebo group (43 of 470 SVGs), odds ratio, 1.29 [95% CI, 0.73-2.30]; P=0.38. SVG failure occurred in 35 (14.2%) patients in the ticagrelor group versus 29 (11.6%) patients in the placebo group (odds ratio, 1.22 [95% CI, 0.72-2.05]). CONCLUSIONS: In this randomized, placebo-controlled trial, the addition of ticagrelor to standard aspirin did not reduce SVG occlusion at 1 year after CABG. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02352402.

Selecting interventions to improve patient-relevant outcomes in health care for aortic valve disease - the Intervention Selection Toolbox.

BACKGROUND: Measuring and improving outcomes is a central element of value-based health care. However, selecting improvement interventions based on outcome measures is complex and tools to support the selection process are lacking. The goal was to present strategies for the systematic identification and selection of improvement interventions applied to the case of aortic valve disease and to combine various methods of process and outcome assessment into one integrated approach for quality improvement. METHODS: For this case study a concept-driven mixed-method approach was applied for the identification of improvement intervention clusters including: (1) benchmarking outcomes, (2) data exploration, (3) care delivery process analysis, and (4) monitoring of ongoing improvements. The main outcome measures were long-term survival and 30-day mortality. For the selection of an improvement intervention, the causal relations between the potential improvement interventions and outcome measures were quantified followed by a team selection based on consensus from a multidisciplinary team of professionals. RESULTS: The study resulted in a toolbox: the Intervention Selection Toolbox (IST). The toolbox comprises two phases: (a) identifying potential for improvement, and (b) selecting an effective intervention from the four clusters expected to lead to the desired improvement in outcomes. The improvements identified for the case of aortic valve disease with impact on long-term survival in the context of the studied hospital in 2015 include: anticoagulation policy, increased attention to nutritional status of patients and determining frailty of patients before the treatment decision. CONCLUSIONS: Identifying potential for improvement and carefully selecting improvement interventions based on (clinical) outcome data demands a multifaceted approach. Our toolbox integrates both care delivery process analyses and outcome analyses. The toolbox is recommended for use in hospital care for the selection of high-impact improvement interventions.

Anaesthesia geriatric evaluation to guide patient selection for preoperative multidisciplinary team care in cardiac surgery.

BACKGROUND: A multidisciplinary approach to improve postoperative outcomes in frail elderly patients is gaining interest. Multidisciplinary team care should be targeted at complex patients at high risk for adverse postoperative outcome to limit the strain on available resources and to prevent an unnecessary increase in patient burden. This study aimed to improve patient selection for multidisciplinary care by identifying risk factors for disability after cardiac surgery in elderly patients. METHODS: This was a two-centre prospective cohort study of 537 patients aged ≥70 yr undergoing elective cardiac surgery. Before surgery, 11 frailty characteristics were investigated. Outcome was disability at 3 months defined as World Health Organization Disability Assessment Schedule 2.0 ≥25%. Multivariable modelling using logistic regression, concordance statistic (c-statistic), and net reclassification index was used to identify factors contributing to patient selection. RESULTS: Disability occurred in 91 (17%) patients. Ten out of 11 frailty characteristics were associated with disability. A multivariable model, including the European System for Cardiac Operative Risk Evaluation II and preoperative haemoglobin, yielded a c-statistic of 0.71 (95% confidence interval [CI]: 0.66-0.77). After adding pre-specified frailty characteristics (polypharmacy, gait speed, physical disability, preoperative health-related quality of life, and living alone) to this model, the c-statistic improved to 0.78 (95% CI: 0.73-0.83). The net reclassification index was 0.32 (P<0.001), showing improved discrimination for patients at risk for disability at 3 months. CONCLUSIONS: The addition of preoperative frailty characteristics to a multivariable model improved discrimination between elderly patients with and without disability at 3 months after cardiac surgery, and can be used to guide patient selection for preoperative multidisciplinary team care. CLINICAL TRIAL REGISTRATION: NCT02535728.

Organization of outcome-based quality improvement in Dutch heart centres.

AIMS: Fourteen Dutch heart centres collected patient-relevant outcomes to support quality improvements in a value-based healthcare initiative that began in 2012. This study aimed to evaluate the current state of outcome-based quality improvement within six of these Dutch heart centres. METHODS AND RESULTS: Interviews and questionnaires among physicians and healthcare professionals in the heart centres were combined in a mixed-methods approach. The analysis indicates that the predominant focus of the heart centres is on the actual monitoring of outcomes. A systematic approach for the identification of improvement potential and the selection and implementation of improvement initiatives is lacking. The organizational context for outcome-based quality improvement is similar in the six heart centres. CONCLUSION: Although these heart centres in the Netherlands measure health outcomes for the majority of cardiac diseases, the actual use of these outcomes to improve quality of care remains limited. The main barriers are limitations regarding (i) data infrastructure, (ii) a systematic approach for the identification of improvement potential and the selection and implementation of improvement initiatives, (iii) governance in which roles and responsibilities of physicians regarding outcome improvement are formalized, and (iv) implementation of outcomes within hospital strategy, policy documents, and the planning and control cycle.

A randomized, double-blind, placebo-controlled trial investigating the effect of ticagrelor on saphenous vein graft patency in patients undergoing coronary artery bypass grafting surgery-Rationale and design of the POPular CABG trial.

RATIONALE: An estimated 15% of saphenous vein grafts (SVGs) occlude in the first year after coronary artery bypass grafting (CABG) despite aspirin therapy. Graft occlusion can result in symptoms, myocardial infarction, and death. SVG occlusion is primarily caused by atherothrombosis, in which platelet activation plays a pivotal role. Evidence regarding the effect of stronger platelet inhibition on SVG patency after CABG is limited. The main objective of the POPular CABG trial is to determine whether dual antiplatelet therapy with aspirin plus ticagrelor improves SVG patency when compared to aspirin alone. STUDY: The POPular CABG is a randomized, double-blind, placebo-controlled, multicenter trial investigating the effect of adding ticagrelor to standard aspirin therapy on the rate of SVG occlusion. A total of 500 patients undergoing CABG with ≥ 1 SVG are randomized to ticagrelor or placebo. The primary end point is SVG occlusion rate, assessed with coronary computed tomography angiography at 1 year. Secondary end points are stenoses and occlusions in both SVGs and arterial grafts and SVG failure at 1 year, defined as a composite of SVG occlusion on coronary computed tomography angiography or coronary angiography, SVG revascularization, myocardial infarction in the territory supplied by an SVG, or sudden death. Safety end points are bleeding events at 30 days and 1 year. CONCLUSION: The POPular CABG trial investigates whether adding ticagrelor to standard aspirin after CABG reduces the rate of SVG occlusion at 1 year.

Developing process measures in value-based healthcare: the case of aortic valve disease.

Background: As process measures can be means to change practices, this article presents process measures that impact on outcome measures for surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) within value-based healthcare. Methods: Desk research and observations of patient trajectories were performed to map the processes involved in TAVR and SAVR. Semistructured interviews were conducted with healthcare professionals (n=8) and patients (n=2) to explore which processes were most important in relation to a standard set of outcome measures that was already monitored. Additionally, open interviews (n=2) were held to prioritise results. A focus group was performed for validation of the formulated process measures. Numerical data for these measures was not collected. Results: Process maps of the full cycle of care of TAVR and SAVR treatments in theory and in practice were developed. 28 processes were found important by interview participants due to their expected impact on patient-relevant outcomes. Seven processes were prioritised to be most important and were formulated into 12 process measures for both TAVR and SAVR: 'Number of times that deficient information provision to SAVR patients causes negative outcomes', 'Type of TAVR/SAVR prosthesis', 'Brand of TAVR prosthesis', 'Number of times the frailty score of a TAVR/SAVR patient >75 years is measured', 'Time between TAVR/SAVR surgery indication and surgery', 'Number of times that anticoagulants are stopped within 3 days before surgery', 'Time in hours between TAVR/SAVR surgery and permanent pacemaker implantation' and 'Percentage of standardised pain measurements'. Conclusion: This study proposes an addition of select process measures to standard sets of outcome measures to improve healthcare quality. It illustrates a clear method for identifying process measures with impact on health outcomes in the future.

The implementation of change model adds value to value-based healthcare: a qualitative study.

BACKGROUND: Value-based healthcare (VBHC) is a concept that focuses on outcome measurement to contribute to quality improvement. However, VBHC does not offer a systematic approach for implementing improvement as implementation science does. The aim is to, firstly, investigate the implementation of improvement initiatives in the context of VBHC and secondly, to explore how implementation science could be of added value for VBHC and vice versa. METHODS: A case study with two cases in heart care was conducted; one without the explicit use of a systematic implementation method and the other one with the use of the Implementation of Change Model (ICM). Triangulation of data from document research, semi-structured interviews and a focus group was applied to evaluate the degree of method uptake. Interviews were held with experts involved in the implementation of Case 1 (N = 4) and Case 2 (N = 7). The focus group was held with experts also involved in the interviews (N = 4). A theory-driven qualitative analysis was conducted using the ICM as a framework. RESULTS: In both cases, outcome measures were seen as an important starting point for the implementation and for monitoring change. Several themes were identified as most important: support, personal importance, involvement, leadership, climate and continuous monitoring. Success factors included intrinsic motivation for the change, speed of implementation, complexity and continuous evaluation. CONCLUSION: Application of the ICM facilitates successful implementation of quality- improvement initiatives within VBHC. However, the practical use of the ICM shows an emphasis on processes. We recommend that monitoring of outcomes be added as an essential part of the ICM. In the discussion, we propose an implementation model that integrates ICM within VBHC.

Short- and long-term impact of remifentanil on thermal detection and pain thresholds after cardiac surgery: A randomised controlled trial.

BACKGROUND: The clinical relevance of the suggested hyperalgesic effects of remifentanil is still unclear, especially in the long term. OBJECTIVE: The current study evaluated the impact of remifentanil on thermal thresholds 3 days and 12 months after surgery, measured with Quantitative Sensory Testing. DESIGN: A single-blind, randomised controlled trial. SETTING: A tertiary care teaching hospital in The Netherlands, from 2014 to 2016. PATIENTS: A total of 126 patients aged between 18 and 85 years, undergoing cardiothoracic surgery via sternotomy (coronary artery bypass grafts and/or valve replacement) were included. Exclusion criteria were BMI above 35 kg m, history of cardiac surgery, chronic pain conditions, neurological conditions, allergy to opioids or paracetamol, language barrier and pregnancy. INTERVENTIONS: Patients were allocated randomly to receive intra-operatively either a continuous remifentanil infusion or intermittent intra-operative fentanyl as needed in addition to standardised anaesthesia with propofol and intermittent intravenous fentanyl at predetermined time points. MAIN OUTCOME MEASURES: Warm and cold detection and pain thresholds 3 days and 12 months after surgery. In addition the use of remifentanil, presence of postoperative chronic pain, age, opioid consumption and pre-operative quality of life were tested as a predictor for altered pain sensitivity 12 months after surgery. RESULTS: Both warm and cold detection, and pain thresholds, were not significantly different between the remifentanil and fentanyl groups 3 days and 12 months after surgery (P > 0.05). No significant predictors for altered pain sensitivity were identified. CONCLUSION: Earlier reports of increased pain sensitivity 1 year after the use of remifentanil could not be confirmed in this randomised study using Quantitative Sensory Testing. This indicates that remifentanil plays a minor role in the development of chronic thoracic pain. Still, the relatively high incidence of chronic thoracic pain and its accompanying impact on quality of life remain challenging problems. TRIAL REGISTRATION: The study was registered at EudraCT (ref: 2013-000201-23) and ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02031016).

Defining and Measuring a Standard Set of Patient-Relevant Outcomes in Coronary Artery Disease.

Systematic outcome measurement enables to continuously improve treatment results and stimulates dissemination of best practices. For patients with coronary artery disease, no examples yet exist of standard sets of patient-relevant outcome measures that have already been fully implemented at a large scale in clinical care. The aim of this paper is twofold: (1) to share the standard set of outcome measures as developed by Meetbaar Beter, and (2) to show how the standard set is presented and published to support improvement of cardiac care. A step-wise approach was followed by an expert panel to construct a standard set of outcome measures. This resulted in a comprehensive set of relevant outcome measures, comprising 4 generic and 11 treatment-specific outcomes. Both short-term and long-term outcomes measures up to 5 years of follow-up were included. Relevant initial conditions were selected to enable case-mix adjustment. The standard set has been implemented in 21 hospitals across the Netherlands. The results and experiences have been used to fine-tune the set in 4 reporting cycles in 2012 to 2016, using an annual maintenance cycle. Currently about 83,000 percutaneous coronary interventions and 30,000 coronary artery bypass graftings are included in the dataset, covering the majority of all percutaneous coronary interventions and coronary artery bypass graftings in the Netherlands. In conclusion, Meetbaar Beter has defined and implemented a comprehensive set of patient-relevant outcome measures for coronary artery disease, and the variation of the results among the centers indicates that there are sufficient opportunities to further improve cardiac care in the Netherlands.

Randomized Controlled Trial on the Influence of Intraoperative Remifentanil versus Fentanyl on Acute and Chronic Pain after Cardiac Surgery.

BACKGROUND: Remifentanil has been associated with increased acute and potentially chronic postoperative pain. The objective of this prospective randomized controlled trial was to investigate the influence of intraoperative remifentanil on acute and chronic postoperative pain after cardiac surgery. METHODS: Patients (N = 126) receiving standardized anesthesia with propofol and intermittent intravenous fentanyl at predetermined times for cardiac surgery were randomized to intraoperatively receive either a continuous remifentanil infusion or additional intermittent intraoperative fentanyl as needed. The primary endpoint was chronic thoracic pain at 12 months after surgery. Secondary endpoints were pain at 3 and 6 months after surgery and analgesic requirements and pain levels in the first 72 hours. RESULTS: There was no significant difference in incidence of chronic thoracic pain between the remifentanil and fentanyl groups, respectively (20% vs. 18%; P = 0.817). At 3 months, however, significantly more patients in the remifentanil group reported chronic thoracic pain (51% vs. 33%; P = 0.047). This effect was more pronounced in younger patients and in patients receiving a higher dose of remifentanil (both P < 0.05). The first 24 and 48 hours postoperatively, morphine consumption in the remifentanil group was significantly higher than in the fentanyl group (34.3 mg [interquartile range (IQR) 25.3 to 48.2] vs. 30.2 mg [IQR 19.2 to 38.1], P = 0.028; and 46.8 mg [IQR 33.8 to 59.2] vs. 39.0 mg [IQR 6.2 to 51.4], P = 0.047, respectively). CONCLUSIONS: Intraoperative use of remifentanil during cardiac surgery does not impact chronic postoperative pain 1 year after surgery. Nevertheless, remifentanil increases analgesic requirements and thoracic pain until 3 months after surgery, and its use is therefore less favorable during cardiac surgery.

Effects of epicardial versus transvenous left ventricular lead placement on left ventricular function and cardiac perfusion in cardiac resynchronization therapy: A randomized clinical trial.

INTRODUCTION: Optimal left ventricular (LV) lead position in patients undergoing cardiac resynchronization therapy (CRT) is crucial to achieve an optimal effect on hemodynamics. Due to various difficulties, up to 30% of transvenous LV lead placements fail, or a suboptimal position is achieved. Surgical epicardial LV lead placement could be performed at a position anticipated to be the optimal site. This could have a more favorable effect, which may be expressed by increased improvement in left ventricular ejection fraction (LVEF) and cardiac perfusion. The objective of this trial is to compare transvenous versus epicardial LV lead placement in CRT in a randomized fashion METHODS AND RESULTS: Fifty-two patients were randomized to either epicardial or transvenous approach. All patients received an ICD with CRT. Patients were followed for 6 months after device implant. Primary endpoint was the degree of change in cardiac perfusion measured by myocardial perfusion scintigraphy. LVEF equally improved in both groups, from 24% to 36% in the transvenous group versus 25% to 35% in the epicardial group (P = 0.797). Cardiac perfusion, expressed as summed stress score, improved in both groups without a significant difference as well (P = 0.727). Complication rate was similar, respectively 6 and 7 patients had any complication. Admission time was significantly longer in the epicardial group with 2 (2-7) versus 3 (2-32) days (P <0.001). CONCLUSION: Epicardial LV lead placement does not result in additional improvement of LVF or myocardial perfusion compared to the conventional transvenous in CRT.