Timing of Chest Tube Removal Following Adult Cardiac Surgery: A Cluster Randomized Controlled Trial.

OBJECTIVES: Early chest tube removal following cardiac surgery may be associated with an increased risk of pleural or pericardial effusions following cardiac surgery. This study compares the effects of two fast-track chest tube removal protocols regarding the risk of pleural or pericardial effusions, requirement of opioids, respiratory function, and postoperative complications. DESIGN: Prospective non-blinded cluster-randomized study with alternating chest tube removal protocol in adult patients undergoing elective cardiac surgery. Monthly changing allocation to scheduled chest tube removal on the day of surgery (Day 0) versus removal on the 1st postoperative day (Day 1) provided no air leakage and output < 200 mL within the last four hours. RESULTS: A total of 527 patients were included in the study from September 1st 2020 until October 29th 2021 and randomly allocated to chest tube removal at day 0 (n = 255), and day 1 (n = 272). More than every fourth patient required drainage for pleural effusion with no significant difference between the groups. Earlier removal of chest tubes did not reduce requirement of analgesics, improve early respiratory function, or reduce postoperative complications. The study was halted for futility after halfway interim analysis showed insufficient promise of any treatment benefit. CONCLUSION: Fast-track protocols with chest tube removal within the first 24 h after cardiac surgery may be associated a high rate of pleural effusions.

Feasibility of early digital health rehabilitation after cardiac surgery in the elderly: a qualitative study.

BACKGROUND: Increasing numbers of elderly patients experience prolonged decreased functional capacity and impaired quality of life after seemingly successful cardiac surgery. After discharge from hospital, these patients experience a substantial gap in care until centre-based cardiac rehabilitation commences. They may benefit from immediate coaching by means of mobile health technology to overcome psychological and physiological barriers to physical activity. The aim of this study was to explore the usability, acceptability, and relevance of a mobile health application designed to support remote exercise-based cardiac rehabilitation of elderly patients early after cardiac surgery from the perspective of patients, their relatives, and physiotherapists. METHODS: We adapted a home-based mobile health application for use by elderly patients early after cardiac surgery. Semi-structured dyadic interviews were conducted with a purposive sample of patients (n = 9), their spouses (n = 5), and physiotherapists (n = 2) following two weeks of the intervention. The transcribed interviews were analysed thematically. RESULTS: Three themes were identified: 1) creating an individual fit by tailoring the intervention; 2) prioritizing communication and collaboration; and 3) interacting with the mobile health application. Overall, the findings indicate that the mobile health intervention has the potential to promote engagement, responsibility, and motivation among elderly patients to exercise early after surgery. However, the intervention can also be a burden on patients and their relatives when roles and responsibilities are unclear. CONCLUSION: The mobile health intervention showed potential to bridge the intervention gap after cardiac surgery, as well as in fostering engagement, responsibility, and motivation for physical activity among elderly individuals. Nevertheless, our findings emphasize the necessity of tailoring the intervention to accommodate individual vulnerabilities and capabilities. The intervention may be improved by addressing a number of organizational and communicational issues. Adaptions should be made according to the barriers and facilitators identified in this study prior to testing the effectiveness of the intervention on a larger scale. Future research should focus on the implementation of a hybrid design that supplements or complements face-to-face and centre-based cardiac rehabilitation. TRIAL REGISTRATION: Danish Data Protection Agency, Central Denmark Region (1-16-02-193-22, 11 August 2022).

The left atrial appendage closure by surgery-2 (LAACS-2) trial protocol rationale and design of a randomized multicenter trial investigating if left atrial appendage closure prevents stroke in patients undergoing open-heart surgery irrespective of preoperative atrial fibrillation status and stroke risk.

BACKGROUND: Current recommendations regarding the use of surgical left atrial appendage (LAA) closure to prevent thromboembolisms lack high-level evidence. Patients undergoing open-heart surgery often have several cardiovascular risk factors and a high occurrence of postoperative atrial fibrillation (AF)-with a high recurrence rate-and are thus at a high risk of stroke. Therefore, we hypothesized that concomitant LAA closure during open-heart surgery will reduce mid-term risk of stroke independently of preoperative AF status and CHA2DS2-VASc score. METHODS: This protocol describes a randomized multicenter trial. Consecutive participants ≥18 years scheduled for first-time planned open-heart surgery from cardiac surgery centers in Denmark, Spain, and Sweden are included. Both patients with a previous diagnosis of paroxysmal or chronic AF, as well as those without AF, are eligible to participate, irrespective of their CHA2DS2-VASc score. Patients already planned for ablation or LAA closure during surgery, with current endocarditis, or where follow-up is not possible are considered noneligible. Patients are stratified by site, surgery type, and preoperative or planned oral anticoagulation treatment. Subsequently, patients are randomized 1:1 to either concomitant LAA closure or standard care (ie, open LAA). The primary outcome is stroke, including transient ischemic attack, as assigned by 2 independent neurologists blinded to the treatment allocation. To recognize a 60% relative risk reduction of the primary outcome with LAA closure, 1,500 patients are randomized and followed for 2 years (significance level of 0.05 and power of 90%). CONCLUSIONS: The LAACS-2 trial is likely to impact the LAA closure approach in most patients undergoing open-heart surgery. TRIAL REGISTRATION: NCT03724318.

The impact of minimal invasive extracorporeal circulation on postoperative kidney function.

INTRODUCTION: Acute kidney injury following cardiac surgery is a frequent complication associated with increased mortality and morbidity. Minimal invasive extracorporeal circulation is suggested to preserve postoperative renal function. The aim of this study was to assess the impact of minimal invasive versus conventional extracorporeal circulation on early postoperative kidney function. METHODS: Randomized controlled trail including 60 patients undergoing elective stand-alone coronary artery bypass graft surgery and allocated in a 1:1 ratio to either minimal invasive (n = 30) or conventional extracorporeal circulation (n = 30). Postoperative kidney injury was assessed by elevation of plasma neutrophil gelatinase-associated lipocalin (NGAL), a sensitive tubular injury biomarker. In addition, we assessed changes in estimated glomerular filtration rate (eGFR), and the incidence of acute kidney injury according to the Acute Kidney Injury Network (AKIN) classification. RESULTS: We observed no differences between groups regarding increase of plasma NGAL (p = 0.31) or decline of eGFR (p = 0.82). In both groups, 6/30 patients developed acute kidney injury according to the AKIN classification, all regaining preoperative renal function within 30 days. CONCLUSION: Our findings challenge the superiority of minimal invasive compared to conventional extracorporeal circulation in terms of preservation of renal function following low-risk coronary surgery.

No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.

The SWEDEGRAFT study (ClinicalTrials.gov Identifier: NCT03501303) tests the hypothesis that saphenous vein grafts (SVGs) harvested with the "no-touch" technique improves patency of coronary artery bypass grafts compared with the conventional open skeletonized technique. This article describes the rationale and design of the randomized trial and baseline characteristics of the population enrolled during the first 9 months of enrollment. The SWEDEGRAFT study is a prospective, binational multicenter, open-label, registry-based trial in patients undergoing first isolated nonemergent coronary artery bypass grafting (CABG), randomized 1:1 to no-touch or conventional open skeletonized vein harvesting technique, with a planned enrollment of 900 patients. The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years. High-quality health registries and coronary computed tomography angiography are used to assess the primary end point. The secondary end points include wound healing in the vein graft sites and the composite outcome of major adverse cardiac events during the first 2 years based on registry data. Demographics of the first 200 patients enrolled in the trial and other CABG patients operated in Sweden during the same time period are comparable when the exclusion criteria are taken into consideration. RCT# NCT03501303.

Outcome of hybrid compared to conventional revascularization in multivessel coronary artery disease.

OBJECTIVES: Evaluation of 3-year clinical outcome of hybrid myocardial revascularization (HMR) compared to conventional revascularization strategies in patients with multivessel coronary artery disease involving the proximal left anterior descending artery. Design. Retrospective matched cohort study based on a prospective feasibility study including 103 elective patients undergoing staged HMR from October 2010 until February 2012. The Western Denmark Heart Registry was used to identify patients who underwent coronary artery bypass grafting (CABG) and multivessel percutaneous coronary intervention (PCI) by matching on number of diseased vessels, age and comorbidity score. Primary endpoint was the composite rate of major adverse cardiovascular and cerebrovascular events (MACCE) at 3-year follow-up. Secondary endpoints included individual MACCE components, acute kidney injury, and cardiovascular readmissions. Results. There was no difference between MACCE in the three groups (HMR 31.1%; CABG 20.4%; PCI 20.4%, p = .11). Estimates of repeat revascularization were significantly increased with HMR versus CABG. In the CABG group, fewest patients required cardiovascular readmissions though with the highest incidence of acute kidney injury. Conclusions. HMR was not superior with respect to MACCE compared with CABG and PCI. It may, however, represent a safe alternative to conventional revascularization treatment considering the specific procedure-associated morbidity.

Transient internal mammary artery graft stenosis on early angiography: navigating pitfalls in hybrid myocardial revascularization.

OBJECTIVES: Left internal mammary artery (LIMA) graft stenoses detected at early coronary angiography may be reversible and consequently prompt unnecessary graft revision. We aim to investigate the frequency, natural course, and clinical significance of internal mammary artery graft stenosis upon early angiography in patients undergoing hybrid myocardial revascularization. METHODS: In this retrospective sub-study of the Coronary Hybrid Revascularization Study, we compared graft appearance, ie, stenosis degree and flow, on early (in-hospital) and scheduled follow-up coronary angiography after 1 year. We assessed the change in graft patency using the Fitzgibbon classification (grade A: unimpaired runoff; grade B > 50% stenosis; grade O: occlusion), as well as graft association with adverse events (death, myocardial infarction, stroke, and repeat revascularization) at up to 5-year follow-up. RESULTS: We report clinical follow-up data for all 131 patients included in the Coronary Hybrid Revascularization Study. Change in graft patency was analyzed in 86 patients with satisfactory visualization of the LIMA graft on early and follow-up coronary angiography. All LIMA grafts were patent at discharge and follow-up. Twenty-seven of 37 (73%) grade B graft stenoses at early angiography resolved to grade A during follow-up of median 12 months (range, 8-83 months) after surgery. Angiographically significant graft stenoses at early coronary angiography were not associated with adverse clinical outcome up to 5-year follow-up. CONCLUSIONS: Our results suggest that the majority of clinically silent LIMA graft stenoses resolve during follow-up and are not associated with adverse clinical outcomes.

Impact of minimal invasive extracorporeal circulation on systemic inflammatory response - a randomized trial.

BACKGROUND: Extracorporeal circulation causes a systemic inflammatory response, that may cause postoperative haemodynamic instability and end-organ dysfunction. This study aimed to investigate the impact of minimal invasive extracorporeal circulation (MiECC) on the systemic inflammatory response compared with conventional extracorporeal circulation (CECC). METHODS: Patients undergoing coronary artery bypass grafting were randomized to MiECC (n = 30) and CECC (n = 30). Primary endpoint was tumor necrosis factor-α. Secondary endpoints were other biochemical markers of inflammation (IL1ß, IL6 and IL8, C-reactive protein, leukocytes), and markers of inadequate tissue perfusion and tissue damage (lactate dehydrogenase, lactate and creatine kinase-MB). In addition, we registered signs of systemic inflammatory response syndrome, haemodynamic instability, atrial fibrillation, respiratory dysfunction, and infection. RESULTS: Patients treated with MiECC showed significantly lower levels of tumor necrosis factor-α than CECC during and early after extracorporeal circulation (median: MiECC 3.4 pg/mL; CI 2.2-4.5 vs. CECC 4.6 pg/mL; CI 3.4-5.6; p = 0.01). Lower levels of creatine kinase-MB and lactate dehydrogenase suggested less tissue damage. However, we detected no other significant differences in any other markers of inflammation, tissue damage or in any of the clinical outcomes. CONCLUSIONS: Lower levels of TNF-α after MiECC compared with CECC may reflect reduced inflammatory response, although other biochemical markers of inflammation were comparable. Our results suggest better end-organ protection with MiECC compared with CECC. Clinical parameters related to systemic inflammatory response were comparable in this study. CLINICAL REGISTRATION NUMBER: NCT03216720.

Perioperative anaesthesia by local infiltration following median sternotomy - a study protocol.

INTRODUCTION: Post-operative pain following open heart surgery is a clinical challenge usually requiring significant amounts of opioids. Long-acting local infiltration anaesthesia may effectively reduce post-operative opioid consumption and improve recovery. The trial is a publicly funded, double-blinded, randomised, placebo-controlled trial evaluating the effect of long-acting local infiltration anaesthesia in open heart surgery. METHODS: Two Danish centres are planning to randomise 100 patients undergoing coronary artery bypass grafting to treatment with long-acting infiltration anaesthesia or placebo. We compare an active solution of bupivacaine, adrenaline, clonidine and dexamethasone with saline placebo. The primary outcome measure is the accumulated opioid use within the first 24 post-operative hours. Secondary outcome measures include evaluation of respiratory function, patient-reported pain scores, mobilisation, opioid-associated side effects and long-term opioid consumption. CONCLUSION: This trial will define whether the use of long-acting infiltration anaesthesia during heart surgery may reduce acute and prolonged post-operative opioid consumption. Reduction of opioid-related adverse effects may improve recovery. FUNDING: The trial is supported by public grants (Dansk Selskab for Anæstesiologi og Intensiv Medicin: 40,000 DKK; Regionernes Medicin og Behandlingspulje 2022: 686,000 DKK). The work of I. S. Modrau is supported by an unrestricted grant from the Health Research Foundation of the Central Denmark Region. TRIAL REGISTRATION: EudraCT 2021-005886-41.

Clinical Outcomes After Surgical Revascularization Using No-Touch Versus Conventional Saphenous Vein Grafts: Mid-Term Follow-Up of Propensity Score Matched Cohorts.

Previous studies have demonstrated superior patency of no-touch as compared to conventional saphenous vein grafts in coronary artery bypass grafting. We aimed to compare mid-term clinical outcomes of both techniques in a large cohort of routine patients. We identified all patients undergoing nonemergent primary coronary artery bypass grafting with either no-touch or conventional saphenous vein grafts at our institution between 2000 and 2020. Propensity score matching was used to create adjusted cohorts based on 5288 eligible patients. The primary outcome was the combined endpoint of all-cause mortality and repeat revascularization. Secondary outcomes were individual rates of all-cause mortality and repeat revascularization, surgical complications, and short-term mortality. Propensity score matching resulted in cohorts of no-touch (n = 923) and conventional (n = 923) saphenous vein grafted patients with comparable baseline characteristics. Mean follow-up time was significantly shorter for the no-touch compared to the conventional cohort (4.9 ± 2.3 vs 8.3 ± 2.6 years, P < 0.001). Up to 7-year follow-up, neither the rate of the primary composite endpoint nor death differed significantly between the cohorts. The rate of repeat revascularization was significantly higher in patients in the no-touch cohort (12.9% vs 9.3% at 7-year follow-up, P = 0.022. Post-hoc analysis of percutaneous coronary intervention during follow-up revealed comparable rates of saphenous vein graft failure (no-touch 42/923 (4.6%) vs conventional 32/923 (3.5%), P = 0.286). In this large propensity score matched registry study, coronary artery bypass with no-touch compared to conventional saphenous vein grafting did neither enhance mid-term survival nor reduce the rate of repeat revascularization.

Post-operative iron in cardiac surgery trial - a protocol for a randomised controlled trial.

INTRODUCTION: Anaemia is common after cardiac surgery and has a negative impact on rehabilitation and patient well-being. We aim to compare the efficacy of single, high-dose intravenous iron therapy versus oral iron supplementation to correct anaemia following open cardiac surgery. METHODS: We present a randomised, active-control superiority trial. Adult patients with moderate anaemia (haemoglobin 5.0-6.8 mmol/l) on the first post-operative day after first-time, non-emergent cardiac surgery are eligible. After stratification by gender, 110 patients are randomised 1:1 to either single, high-dose intravenous iron therapy (20 mg/kg ferric derisomaltose) or oral iron supplementation (100 mg ferrous sulphate orally twice daily). The primary outcome measure at the four-week follow-up is the proportion of participants who are neither anaemic (haemoglobin less-than 8.1 mmol/l in men and less-than 7.5 mmol/l in women) nor have received allogeneic red blood cells since randomisation. Secondary outcome measures include changes in haemoglobin and iron biomarkers, exercise capacity, patient-reported outcome measures and cost of care at the four-week follow-up. CONCLUSION: The results of the PICS trial may fundamentally alter future management of anaemia following cardiac surgery. FUNDING: The study is supported by Aarhus University Hospital, an unrestricted research grant by Pharmacosmos A/S (Holbæk, Denmark) and an independent grant from the Health Research Foundation of the Central Denmark Region (ISM). TRIAL REGISTRATION: EudraCT number: 2020-001389-12; Clinical Trials ID: NCT04608539.

[Trikuspidalklapinsufficiens].

Tricuspid regurgitation (TR) has in recent literature been described as an independently progressive disorder associated with a poor prognosis. Studies have emphasized the importance of a more proactive approach in treating TR in order to prevent progression of right ventricular dysfunction and ultimately right heart failure. These findings have renewed interest in surgical treatment for isolated TR whilst also fueling rapid advancements in transcatheter therapies, as argued in this review.

Outcomes of isolated tricuspid valve surgery in contemporary practice.

OBJECTIVES: Isolated tricuspid valve (TV) surgery is rarely performed and has been associated with high mortality and morbidity. The aim of this study was to describe the clinical outcome and functional capacity following isolated TV surgery in contemporary practice. METHODS: We conducted a retrospective cohort study including all patients who underwent isolated TV surgery at our institution from 2013 to 2019. Our cohort was identified using the Western Denmark Heart Registry. Postoperative outcomes were evaluated using patients' medical records. The clinical and echocardiographic status was reported for patients who survived beyond 1 year. RESULTS: We included 43 patients [mean age 65.2 ± 13.8, median European System for Cardiac Operative Risk Evaluation II 1.8 (interquartile range 2.0)]. Twelve (27.9%) had prior cardiac surgery. Up to 90-day follow-up, no patient died and major morbidity was limited to 4 patients (9.3%) requiring pacemaker implantation and 1 patient requiring 2 reoperations. Within 1 year, 4 patients (9.3%) died. Nine patients (20.1%) required single readmission for cardiac reasons during the median follow-up of 38.4 months (interquartile range 30.9 months). All patients who survived beyond 1 year (n = 39) completed clinical follow-up. At follow-up, 38/39 (97.4%) patients were New York Heart Association I or II compared to 12/39 (30.8%) preoperatively (P = 0.001). The presence of oedema and intensity of diuretic treatment were significantly reduced (P = 0.005 and P = 0.008, respectively). Echocardiographic follow-up showed significant improvement of TV dysfunction in all patients. CONCLUSIONS: Our results suggest that isolated TV surgery can be performed safely and greatly improve patients' functional status. Our findings support the importance of optimal surgical timing and patient selection.

Impact of perioperative course during cardiac surgery on outcomes in patients 80 years and older.

OBJECTIVE: To describe the associations among preoperative characteristics, intraoperative and postoperative factors, and mortality and morbidity after open-heart surgery in patients age ≥80 years. METHODS: This retrospective multicenter register study was based on prospectively collected data of all patients age ≥80 years undergoing open-heart surgery in western Denmark between 1999 and 2016. Logistic regression was used to estimate the associations among preoperative characteristics, intraoperative and postoperative factors, and morbidity and mortality. Bonferroni correction was used for multiple comparisons. RESULTS: The study population included 2342 patients age ≥80 years undergoing open-heart surgery. We observed an association between severely impaired preoperative renal function and death within 1-year postsurgery (odds ratio [OR], 4.6; 95% confidence interval [CI], 2.7-7.2). Furthermore, renal clearance <40 mL/min and prolonged cardiopulmonary bypass time of >180 minutes were associated with a >50% probability of death within 1 year. The adjusted OR for death within 1 year was increased significantly with a postoperative length of stay in intensive care of ≥3 days (OR, 5.9; 95% CI, 4.1-8.6) and a duration of postoperative mechanical ventilation ≥2 days (OR, 7.5; 95% CI, 4.1-13.9). Various preoperative and intraoperative characteristics were associated with in-hospital dialysis, in particular cardiopulmonary bypass time >180 minutes (OR, 11.6; 95% CI, 4.7-28.5). CONCLUSIONS: Our findings emphasize the importance of careful referral regarding the procedural burden for very elderly patients and may provide support for informed patient discussions about prognosis and recovery.

Major penetrating thoracic trauma - The importance of collaboration between different specialties.

INTRODUCTION: Penetrating thoracic trauma presents a rare and serious condition with great diversity in impalement mechanisms and following injuries, resulting in a high mortality. This case reports successful management of a severe thoracic trauma and need for collaboration between surgical specialties. PRESENTATION OF CASE: An 18-year-old, otherwise healthy, Caucasian female had penetration of the chest with a wooden post due to a solo car accident and was admitted to a Level 1 trauma center at a university hospital. Trauma computed tomography scan showed costa fractures and fracture of the left clavicular bone. Damage to the subclavian artery, the brachial plexus and pulmonary artery were suspected. Extracorporeal circulation was on standby at surgery. However, removal of the foreign object did not result in any major bleeding. The patient was discharged from hospital on the 19th day after surgery. Fifteen months after the trauma, surgery was performed to remove the first two costae on the left side, as a disfiguring prominence on the neck was the patients' only complaint. DISCUSSION: Initial management of the patient should follow ATLS® principles with stabilization of airways, breathing and circulation. Multidisciplinary approach resulted in reconstruction of vessels, debridement and wound closure. The importance of follow-up after trauma and surgery are underlined by the current case, as the patient required additional surgery at follow up. CONCLUSION: Multidisciplinary approach to the current penetrating trauma resulted in rapid assessment of injuries and management with excellent outcome.

Impact of minimally invasive extracorporeal circulation on coagulation-a randomized trial.

OBJECTIVES: Minimally invasive extracorporeal circulation (MiECC) is suggested to have favourable impact on blood loss compared to conventional extracorporeal circulation. We aimed to compare the impact of both systems on coagulation. METHODS: Randomized trial comparing endogenous thrombin-generating potential early after elective coronary surgery employing either MiECC group (n = 30) or conventional extracorporeal circulation group (n = 30). Secondary outcomes were in vivo thrombin generation, bleeding end points and haemodilution, as well as morbidity and mortality up to 30-day follow-up. RESULTS: Compared to the conventional extracorporeal circulation group, the MiECC group showed (i) a trend towards a higher early postoperative endogenous thrombin-generating potential (P = 0.06), (ii) lower intraoperative levels of thrombin-antithrombin complex and prothrombin fragment 1 + 2 (P < 0.001), (iii) less haemodilution early postoperatively as measured by haematocrit and weight gain, but without correlation to coagulation factors or bleeding end points. Moreover, half as many patients required postoperative blood transfusion in the MiECC group (17% vs 37%, P = 0.14), although postoperative blood loss did not differ between groups (P = 0.84). Thrombin-antithrombin complex levels (rs = 0.36, P = 0.005) and prothrombin fragment 1 + 2 (rs = 0.45, P < 0.001), but not early postoperative endogenous thrombin-generating potential (rs = 0.05, P = 0.72), showed significant correlation to increased transfusion requirements. The MiECC group demonstrated significantly lower levels of creatine kinase-MB, lactate dehydrogenase and free haemoglobin indicating superior myocardial protection, less tissue damage and less haemolysis, respectively. Perioperative morbidity and 30-day mortality did not differ between groups. CONCLUSIONS: Conventional but not MiECC is associated with significant intraoperative thrombin generation despite full heparinization. No correlation between coagulation factors or bleeding end points with the degree of haemodilution could be ascertained. CLINICALTRIALS.GOV IDENTIFIER: NCT03216720.

One-year cost-effectiveness and safety of simultaneous hybrid coronary revascularization versus conventional coronary artery bypass grafting.

OBJECTIVES: To evaluate the cost-effectiveness and safety of simultaneous hybrid coronary revascularization (sHCR) compared to conventional coronary artery bypass grafting (CABG) in elective patients with multivessel coronary artery disease. METHODS: Cost-utility analysis of a prospective cohort follow-up study comparing per protocol 50 sHCR patients to 50 contemporaneous matched patients undergoing CABG. Resource utilization data and health-related quality of life were collected prospectively, and the cumulative 1-year costs were assessed from the Danish health sector perspective. Effectiveness was measured by quality-adjusted life years using EuroQol-5D. Probabilistic sensitivity analyses using bootstrapping were conducted. Secondary safety measures including early clinical outcomes and freedom from major adverse cardiac or cerebrovascular events at 1 year were assessed. RESULTS: The clinical trial was discontinued prematurely due to safety reasons after inclusion of 50 patients (24 sHCR; 26 CABG), as the chest tube output and the risk of postoperative pleural effusions requiring thoracocentesis were significantly increased following sHCR compared with CABG. Based on 48 patients available for 1-year follow-up, both treatment strategies were similarly effective (quality-adjusted life year difference between the groups -0.019), with a net cost difference in favour of conventional CABG estimated to be €2173 per patient. Exclusion of 1 outlier patient with chronic renal failure and deep sternal wound infection in the sHCR group resulted in an equalization of the total 1-year costs. CONCLUSIONS: At 1 year, sHCR was less cost-effective than conventional CABG and associated with higher chest tube output and a higher risk of postoperative pleural effusions requiring thoracocentesis. CLINICAL TRIAL REGISTRATION: NCT01496664.

The absorption of aspirin is reduced after coronary artery bypass grafting.

BACKGROUND: Despite treatment with the antiplatelet drug aspirin, some patients who undergo coronary artery bypass grafting (CABG) experience a thromboembolic event in the early postoperative period. The etiology of a reduced aspirin effect after CABG is still unsolved. Hence, we investigated whether patients who undergo CABG have a reduced absorption of aspirin after surgery, measured as levels of plasma salicylic acid (SA). METHODS: In total, 53 patients were included between October 2015 and May 2018. Blood samples where obtained at the day before surgery, and at the first (day 1) and second (day 2) postoperative day. A subgroup of 10 patients had additional blood samples obtained on day 1. Plasma SA was measured using liquid chromatography-electrospray-ionization tandem-mass spectrometry. Multiplate Analyzer (Roche, Roche Diagnostics, Mannheim, Germany) and VerifyNow Aspirin Test (Accumetrics, San Diego, Calif) were used to assess platelet aggregation as a measurement of the antiplatelet effect of aspirin. RESULTS: A comparison of the difference in change of SA concentration between the day before surgery with day 1 and day 2 showed a significantly reduced increase in SA plasma levels after intake of aspirin at day 1 and day 2 after surgery (P < .0001), including a significantly reduced SA increase in the subgroup at 2, 3, and 4 hours after intake of aspirin. Corresponding with a reduced effect of aspirin, neither Multiplate Analyzer arachidonic acid, nor VerifyNow Aspirin Test showed a significant reduction in platelet aggregation 1 hour after intake of aspirin at day 1 (P < .0001). This also accounted for the subgroup 2, 3, and 4 hours after aspirin intake on day 1. At day 2 the same pattern as preoperatively was detected. CONCLUSIONS: After CABG, the SA level and the effect of aspirin were reduced in the immediate postoperative period.

Durability after aortic valve replacement with the Mitroflow versus the Perimount pericardial bioprosthesis: a single-centre experience in 2393 patients.

OBJECTIVES: This study compares the durability and risk of reoperation in patients undergoing aortic valve replacement (AVR) with either a Mitroflow or a Carpentier-Edwards (CE) pericardial bioprosthesis. Since AVR with bioprosthetic valves has increased progressively in recent years as compared to mechanical valves, especially in patients aged 60-70 years, there has been renewed interest in the long-term durability of current pericardial bioprostheses. METHODS: We compared 440 AVR with Mitroflow valves with 1953 AVR with CE pericardial valves implanted from 1999 to 2014 with regard to reoperation, reoperation for structural valve deterioration (SVD) and all-cause mortality. RESULTS: Ten-year freedom from explant of any cause was higher for CE Perimount (98 ± 0.7%) than for Mitroflow (95 ± 1.4%, P < 0.01). Reasons for explant for CE Perimount were SVD (n = 2), endocarditis (n = 8) and paraprosthetic leak (n = 10). The reasons for explant for Mitroflow were SVD (n = 11), endocarditis (n = 3) SVD and pericarditis (n = 1) and paraprosthetic leak (n = 2). Ten-year freedom from explant due to SVD was higher for CE Perimount (100%) than for Mitroflow (96%) (P < 0.01). In small aortic annuli (bioprosthesis size 19-21 mm), freedom from SVD at 10 years for CE Perimount and Mitroflow was 100 versus 96%, respectively. By multivariate analysis, it was found that bioprosthesis size was not a risk factor for SVD. The choice of valve type could not be demonstrated to influence long-term survival. CONCLUSIONS: The Mitroflow pericardial bioprosthesis provides less than optimal mid- and long-term durability compared with the CE Perimount pericardial valve, especially for small aortic diameter implants (19 and 21 mm). This study hereby confirms the existence of a real risk of valvular deterioration of the Mitroflow valve that might compromise the prognosis of the patients.

Reduced Effect of Aspirin and Clopidogrel Following Hybrid Coronary Revascularization.

OBJECTIVE: Reduced effect of antiplatelet therapy following coronary artery bypass grafting is associated with reduced graft patency. We sought to evaluate the impact of hybrid coronary revascularization on the effect of aspirin and clopidogrel and whether high baseline platelet aggregation, high postoperative levels of platelet turnover, and acute-phase response may contribute to the effect. METHODS: We prospectively studied platelet aggregation (VerifyNow and Multiplate Analyzer), platelet turnover (immature platelets, mean platelet volume, and thrombopoietin), and acute-phase reactants (C-reactive protein, von Willebrand factor, and coagulation factor VIII) in 40 patients undergoing elective hybrid coronary revascularization (off-pump surgical revascularization through J-hemisternotomy followed by percutaneous coronary intervention [PCI]). Preoperative blood samples on- and off-aspirin were compared with blood samples obtained postoperatively, following PCI when dual antiplatelet therapy had been initiated and at 1-year follow-up. RESULTS: The antiplatelet effect of aspirin was significantly reduced in the early postoperative period as measured by VerifyNow Aspirin but not by Multiplate ASPI test. The antiplatelet effect of clopidogrel was significantly reduced following PCI as measured by VerifyNow P2Y12 and Multiplate ADP test. The level of baseline aggregation did not predict the antiplatelet effect of aspirin or clopidogrel, and no association was found between platelet aggregation and postoperative platelet turnover or acute-phase reaction. CONCLUSIONS: A transient reduction in the antiplatelet effect of aspirin and clopidogrel was observed after hybrid coronary revascularization despite limited surgical trauma and off-pump technique. Neither baseline platelet aggregation nor postoperatively increased platelet turnover and acute-phase response could explain this finding. ClinicalTrials.gov identifier, NCT02293928.