[Requirements for outpatient care after implantation of a ventricular assist device : Views of patients and their relatives]. / Anforderungen an die ambulante Versorgung nach Implantation eines ventrikulären Herzunterstützungssystems : Sichtweise von Patienten und Angehörigen.

Ventricular assist device (VAD) implantation has developed into a well-established option when conservative treatment of terminal heart failure has been exhausted. Figures from 2015 make this clear: only 283 heart transplantations were performed nationwide but 959 VAD systems were implanted. It is noteworthy that the survival times with a VAD are approaching the survival times after heart transplantation. Patients with VADs have a life-long dependency on their proximity to specialists. So far, the requirements for outpatient care have not been systematically recorded from the perspective of VAD patients and their relatives. In September 2016, VAD patients (n = 30) and their relatives (n = 25) were anonymously questioned about their views on postoperative outpatient care. For this purpose, the VAD Patient Satisfaction Survey was adapted to the needs of this study. Patients with VADs and their relatives were found to experience their daily life with a VAD in a positive manner. Information, training, accessibility and regular contacts with the implantation clinic and the VAD coordinator are important pillars of outpatient care after VAD implantation. Almost 95% of surveyed patients regarded good home support as an important factor that makes life with a VAD easier. These aspects should be taken into account in the care of patients living with a VAD.

[Sense of Coherence Scale according to Antonovsky as a possible predictor for return to work for cardiac surgery intensive care patients]. / "Sense-of-coherence"-Skala nach Antonovsky als möglicher Prädiktor für den Wiedereinstieg in das Berufsleben für herzchirurgische Intensivpatienten.

BACKGROUND: For cardiac surgery patients who were employed prior to surgery, the return to their professional life is of special importance. In addition to medical reasons, such as pre-existing conditions, the success of the operation or postoperative course and patient-intrinsic reasons, which can be assessed with the Sense of Coherence (SOC) scale by Antonovsky, may also play a role in the question of a possible return into working life. METHODS: In this study 278 patients (invasive coronary artery bypass graft surgery and/or surgery on heart valves, age < 60 years, employed) were questioned postoperatively via post with the SOC questionnaire. The SOC questionnaire was used in addition to questions about return to work. The cohort was stratified according to the time of return to work. Subsequently, the point of maximum sensitivity and specificity was determined for the total SOC score and the prediction power was considered. RESULTS: Of the 278 patients, 61 questionnaires (22%) were considered as eligible and included in the analysis. Of these, 47 participants had returned to work after undergoing cardiac surgery and 14 participants had not. We observed significant differences in SOC values between both groups (146.07 ± 29.76 versus 124.29 ± 28.8, p = 0.020). Patients that returned to work within the first 6 months after surgery showed even higher SOC scores (148.56 ± 28.98, p = 0.034). CONCLUSION: Patients with an SOC score < 130 are at greater risk not to return to their professional life after cardiac surgery. The SOC is an easily obtainable score that reliably predicts the probability of return to work after cardiac surgery.

A novel application for assessing diaphragmatic function by ultrasonic deformation analysis in noninvasively ventilated healthy young adults.

PURPOSE: Noninvasive pressure support ventilation is intended to relieve the load on respiratory muscles and to prevent exhaustion. This includes continuous positive airway pressure (CPAP) as well as pressure support ventilation (PSV). Speckle tracking echocardiography (STE) allows quantification of tissue deformation by tracing characteristic grayscale patterns, independent of the acquisition angle. The aim of the present study was to assess the applicability of using STE as a way to investigate diaphragm movement using deformation analysis as a parameter for respiratory workload. MATERIALS AND METHODS: Healthy male subjects (n = 13, 27 ±â€Š7 years) were treated while in a seated supine position with the following respirator settings: regular breathing, 5 mbar CPAP, CPAP + 5 / + 10 / + 15 mbar PSV. A 2 - 4 MhZ M5S phased array sector transducer was used on a Vivid E 9 (GE, Horton, Norway) to visualize the diaphragm. The inspiratory peak transverse strain was measured as a parameter of maximal inspiratory muscle workload and compared to the M-mode-based fractional thickening (FT). RESULTS: Both the FT and the transverse strain increased significantly under CPAP and PSV. The transverse strain correlated well with the FT (r = 0.753; p < 0.001). CONCLUSION: The results measured by STE were comparable to the M-mode-based measurements. The capturing of a larger diaphragmatic sample area and movement tracking possibly lead to higher precision compared to one-dimensional M-mode. The use of STE in patients might provide a reproducible, bedside method to analyze the respiratory workload. Due to the larger sampling area, it might prove superior to mere M-mode acquisition.

Feasibility and safety of xenon compared with sevoflurane anaesthesia in coronary surgical patients: a randomized controlled pilot study.

BACKGROUND: To date, only limited data exist about the use of xenon as an anaesthetic agent in patients undergoing cardiac surgery. The favourable cardio- and neuroprotective properties of xenon might attenuate postoperative complications, improve outcome, and reduce the incidence of delirium. Thus, the aims of this study were to investigate the feasibility and safety of balanced xenon anaesthesia in patients undergoing cardiac surgery and to gather pilot data for a future randomized multicentre study. METHODS: Thirty patients undergoing elective coronary artery bypass grafting were enrolled in this randomized, single-blind controlled trial. They were randomized to receive balanced general anaesthesia with either xenon (45-50 vol%) or sevoflurane (1-1.4 vol%). The primary outcome was the occurrence of adverse events (AEs). Secondary outcome parameters were feasibility criteria (bispectral index, perioperative haemodynamic, and respiratory profile) and safety parameters (dosage of study treatments, renal function, intraoperative blood loss, need for inotropic support, regional cerebral tissue oxygenation). Furthermore, at predefined time points, systemic and pulmonary haemodynamics were assessed by the use of a pulmonary artery catheter. RESULTS: There were no patient characteristic differences between the groups. Patients undergoing xenon anaesthesia did not differ with respect to the incidence of AE (6 vs 8, P=0.464) compared with the sevoflurane group. No differences were detected regarding secondary feasibility and safety criteria. The haemodynamic and respiratory profile was comparable between the treatment groups. CONCLUSIONS: Balanced xenon anaesthesia is feasible and safe compared with sevoflurane anaesthesia in patients undergoing coronary artery bypass surgery. Acronym CARDIAX: A pre- and post-coronary artery bypass graft implantation disposed application of xenon. Clinical trial registration ClinicalTrials.gov: NCT01285271; EudraCT-number: 2010-023942-63. Approved by the ethics committee 'Ethik-Kommission an der Medizinischen Fakultät der Rheinisch-Westfälischen Technischen Hochschule Aachen (RWTH Aachen)': EK-218/10.

Influence of aortic dimensions on the hemodynamic performance of small aortic valve prostheses: impact on patient/prosthesis mismatch.

BACKGROUND: Since Doppler echocardiography takes no account of pressure recovery, the true hemodynamic burden of aortic valve prostheses remains vague. The purpose of this study was to elucidate the methodological error of Doppler gradient estimation by means of a model demonstrating the different influence of aortic root diameters on net and Doppler gradients, respectively. This matters especially in small valves and the related patient/prosthesis mismatch calculation. METHODS: Two bileaflet small aortic valve prostheses (19 mm SJM Regent® and On-X® valve) were tested using a pulsatile circulatory mock loop simulator with two different aortic models: one with statistically normal diameters according to annular size, another one simulating an aortic aneurysm of 50 mm. Doppler and simultaneously recorded net gradients as well as systolic energy losses were obtained for different hemodynamic conditions. RESULTS: In all measurements a significant amount of pressure recovery was observed. In cases of aortic aneurysm systolic energy loss increased significantly for each cardiac output at each heart rate ( P < 0.0028), reflected by a significant ( P < 0.0001) increase in net gradients. The corresponding Doppler gradients were unchanged. This indicates significantly less pressure recovery ( P < 0.0001) in the aneurysmatic aorta. CONCLUSIONS: Geometry of the ascending aorta considerably alters aortic valve hemodynamic parameters. The hemodynamic function of small aortic valve prostheses, especially with corresponding normal outflow dimensions, is much better than expected from Doppler gradients. Thus, calculation of a patient/prosthesis mismatch can be misleading.

Modified technique for thoracomyoplasty after posterolateral thoracotomy.

OBJECTIVE: Thoracomyoplasty after prior posterolateral thoracotomy (PLT) remains a challenge for the thoracic surgeon. Thoracodorsal artery division after PLT impairs the vascularization supply of the latissimus dorsi muscle (LDM) resulting in muscle mass reduction due to distal atrophy. This makes adequate filling of residual empyema space and/or surgical closure of bronchial stump insufficiency more difficult, and they require alternative surgical procedures. We present an alternative approach using a four-muscle flap technique to include the infraspinatus, the subscapularis and the teres major muscle group, all pedicled from the subscapular artery as a part of a modified thoracomyoplasty technique for closing residual empyema space and bronchial stump insufficiency. METHODS: Between 2002 and 2008 we performed the technique in 7 patients with residual empyema space. Three patients had post-tuberculosis syndrome, 2 had postpneumectomy empyema, and 2 had chronic parapneumonic empyema. Three cases were combined with a bronchopleural fistula. All patients underwent a two-stage procedure. First, open window thoracostomy was performed followed by definitive surgical treatment after 3-6 months. In all cases with bronchial insufficiency the stump was covered with a subscapularis muscle flap. The infraspinatus and the teres muscle group were used in combination with a local thoracoplasty. RESULTS: Mean age was 68 +/- 7.9 years. Time from open window thoracostomy to thoracomyoplasty averaged 4 +/- 1.3 months. The number of resected ribs ranged between 4 and 8. Mean postoperative stay in the ICU was 3 +/- 2.9 days. The thoracic drains were removed after 5 +/- 2.3 days. Total hospital stay was 15 +/- 7.6 days. No hospital mortality was noted. Minor postoperative complications occurred in 2 cases. Shoulder function without pain allowed abduction up to 90 degrees. Function was decreased by 16 +/- 9 degrees compared to preoperative evaluation. No severe progressive scoliosis was noted. CONCLUSIONS: Division of the LDM and its vascular supply after posterolateral thoracotomy results in a reduction of muscle mass. The shoulder girdle muscles offer an adequate alternative to fill residual empyema space with acceptable long-term results and restriction in shoulder motion. In all cases with bronchial fistula, bronchial stump closure with a pedicled subscapular muscle was an effective alternative operative technique.

Marfan Syndrome: when to operate TAA(A)s?

Marfan Syndrome is a heritable disorder of connective tissue leading to aortic aneurysms and other cardiovascular complications associated with reduced life expectancy. Marfan patients with thoracic aortic aneurysms (TAAs) or with thoracoabdominal aortic aneurysms (TAAAs) should be treated by means of open surgery, requiring an extensive protocol, including extracorporeal circulation, neuromonitoring and adjunctive modalities to provide organ protection. Then, open surgical repair of TAA(A)s are associated with excellent results. However, in the last time a gradual change to endovascular treatment in Marfan patients is observable. Particularly in patients with an increased surgical risk due to redo sternotomy or thoracotomy, endovascular treatment might be an alternative due to its less invasive approach. Consequently, thoracic endovascular aortic repair comprises a therapeutic alternative in individual situations even in Marfan patients, when the landing zones are safe and appropriate. In cases of failed endovascular therapy, however, conversion to open surgery remains still an option with acceptable results, although the distal and proximal clamping positions change inappropriate with larger extensions due to the aortic stent.

Hypothermia exerts negative inotropy in human atrial preparations: in vitro-comparison to rabbit myocardium.

AIM: We investigated the effect of mild hypothermia on the contractility and calcium response of atrial and ventricular myocardium. METHODS: Human atrial tissue was excised during cannulation process from patients undergoing elective open heart surgery following informed consent. Trabeculae were carefully dissected and compared to rabbit atrial and ventricular trabeculae. All probes were electrically stimulated while clamped to a force transducer and suspended in buffer media. Developed force, time to peak tension and time to 50% of relaxation were measured during mild hypothermia (37-31 degrees C). SR Ca++-content was studied by rapid cooling contractures, Ca++-responsiveness by a stepwise increase of extracellular calcium concentration to 10 mM. RESULTS: Hypothermia decreased twitch tension and SR Ca++-content in human atrial myocardium but increased contractility and SR Ca++-content in rabbit atrial and rabbit ventricular myocardium. Cooling induced a lengthening of contraction and relaxation times in all preparations. In all preparations the positive inotropic response to calcium was diminished at 34 degrees C and almost abolished at 31 degrees C. CONCLUSIONS: In contrast to rabbit ventricular and atrial myocardium, human atrial myocardium showed a negative inotropic effect when exposed to hypothermia. This alteration could be secondary to a declined SR-Ca++ storage and decreased atrial calcium sensitivity. Calcium dependent inotropy is suppressed at temperatures below 34 degrees C.

Inhaled iloprost to control pulmonary artery hypertension in patients undergoing mitral valve surgery: a prospective, randomized-controlled trial.

BACKGROUND: Pulmonary hypertension (PHT) is common in patients undergoing mitral valve surgery and is an independent risk factor for the development of acute right ventricular (RV) failure. Inhaled iloprost was shown to improve RV function and decrease RV afterload in patients with primary PHT. However, no randomized-controlled trials on the intraoperative use of iloprost in cardiac surgical patients are available. We therefore compared the effects of inhaled iloprost vs. intravenous standard therapy in cardiac surgical patients with chronic PHT. METHODS: Twenty patients with chronic PHT undergoing mitral valve repair were randomized to receive inhaled iloprost (25 microg) or intravenous nitroglycerine. Iloprost was administered during weaning from cardiopulmonary bypass (CPB). Systemic and pulmonary haemodynamics were assessed with pulmonary artery catheterization and transoesophageal echocardiography. Milrinone and/or inhaled nitric oxide were available as rescue medication in case of failure to wean from CPB. RESULTS: Inhaled iloprost selectively decreased the pulmonary vascular resistance index after weaning from CPB (208 +/- 108 vs. 422 +/- 62 dyn.s/cm(5)/m(2), P<0.05), increased the RV-ejection fraction (29 +/- 3% vs. 22 +/- 5%, P<0.05), improved the stroke volume index (27 +/- 7 vs. 18 +/- 6 ml/m(2), P<0.05) and reduced the transpulmonary gradient (10 +/- 4 vs. 16 +/- 3 mmHg, P<0.05). In all patients receiving inhaled iloprost, weaning from CPB was successful during the first attempt. In contrast, three patients in the control group required re-institution of CPB and had to be weaned from CPB using rescue medication. CONCLUSIONS: In patients with pre-existing PHT undergoing mitral valve surgery, inhaled iloprost is superior to intravenous nitrogylycerine by acting as a selective pulmonary vasodilator, reducing RV afterload and moderately improving RV-pump performance.

[MRI of the heart following implantation of a left ventricular apico-aortic conduit]. / Kernspintomografie zur umfassenden Untersuchung des Herzens nach Implantation von linksventrikulären apikoaortalen Conduits.

PURPOSE: To investigate the potential of ECG-triggered MRI for the evaluation of postoperative anatomy and function of the heart and conduit following implantation of a left-ventricular apico-aortic conduit. MATERIALS AND METHODS: 5 patients (2 female, 3 male, mean age 72.5 years) were examined using a 1.5 Tesla whole-body MRI (Gyroscan Intera, Philips Medical Systems, Best, The Netherlands) following apico-aortic conduit surgery due to severe aortic valve stenosis. The reason for performing conduit implantation instead of aortic valve replacement was the risk of injuring a bypass graft from prior coronary artery bypass surgery. Cine steady-state-free-precession (SSFP) sequences were used to assess ventricular function, navigator-gated 3D-SSFP and breath-hold, time-resolved contrast-enhanced MR angiography was used to display the postoperative anatomy, and 2D-gradient echo sequences with an inversion pulse to suppress the signal of the healthy myocardium were used to evaluate potential myocardial scarring. Flow sensitive gradient echo sequences were performed to determine the blood flow in the conduit. RESULTS: In all patients the apico-aortic conduit proved to be open with a maximum flow velocity of 126 (+ 43) cm/s. The postoperative anatomy was able to be evaluated in all patients and perioperative myocardial infarction was able to be ruled out. The mean ejection fraction of the left ventricle was 44.2 + 6.2 % with a mean volume of 80 + 20.6 ml per heart beat. CONCLUSION: ECG-triggered MRI is a reliable method for the evaluation of postoperative anatomy and function following implantation of a left ventricular apico-aortic conduit.

Intrathoracic implantation of a continuous flow left ventricular assist device--the microdiagonal blood pump.

AIM: All existing ventricular assist devices are associated with a considerable number of serious complications. We report on our first animal tests with a newly developed microdiagonal blood pump (MDP). METHODS: Six female calves underwent MDP implantation. The inflow and outflow conduit were anastomosed to the left atrium and the descending aorta. The MDP was placed in the left phrenicocostal sinus. Pump flow was adjusted to 2-3 L/min. Hemodynamic and echocardiographic data as well as blood samples were measured over the test period of 7 days. Thereafter, all internal organs and the pump were explanted for thorough examination. RESULTS: Mean arterial (90.5+/-12.1102.7+/-8.7 mmHg) and mean pulmonary arterial (17.3+/-2.420.6+/-2.7 mmHg) pressures remained stable during the test period. Cardiac output (5.4+/-0.5 = or >3.5+/-0.5 L/min) decreased postoperatively due to partial unloading of the heart. Left ventricular end-diastolic (4.4+/-0.5= or >3.8+/-0.4 cm) and end-systolic (3.4+/-0.5 =or >2.9+/-0.4 cm) diameters decreased after MDP implantation and did not change during the test period. Mean number of platelets (550+/-57 =or >350+/-86 x 103/microL) and hemoglobin (13.2+/-1.3 = or >11.9+/-0.8 g/dL) decreased perioperatively due to surgical reasons and recovered in the postoperative course. Free hemoglobin was slightly enhanced in the postoperative course. CONCLUSION: Our results demonstrate that the MDP is suitable for intrathoracic implantation and provides a reliable left ventricular unloading.

[The cardiac surgeon's role in intensive care]. / Intensivmedizin aus Sicht des Herzchirurgen.

During recent years there has been an ongoing process of profound change in German hospitals to save money because of governmental directives. This is also true for the management of hospitals and their departments, leading to new interdisciplinary wards. Therefore this article discusses the management of intensive care units from the cardiac surgeon's view and presents the "Aachen Model" as a possible solution.

Regression of left ventricular hypertrophy after surgical therapy for aortic stenosis is associated with changes in extracellular matrix gene expression.

BACKGROUND: Regression of left ventricular hypertrophy (LVH) after surgical correction for aortic stenosis is not fully understood on the molecular level. The aim of this study was to examine whether there is an association between LVH regression and extracellular matrix (ECM) gene expression. METHODS AND RESULTS: A standard model of controlled LVH induction by supracoronary banding (A=baseline) was applied in 44 growing sheep (age, 6 to 8 months). Surgical correction to release the pressure gradient was performed 8.3+/-1 months later (B). The animals were killed after another 10.1+/-2 months (C). At all time points, hemodynamic evaluations and quantitative analysis of mRNA and protein expression for matrix metalloproteinases (MMP) and their tissue inhibitors (TIMP) was performed. Left ventricular mass index was 82+/-21 (A) versus 150+/-33 (B), P<0.01, and 78+/-18 g/m(2) (C), P<0.01. Left ventricular function and cardiac index remained stable. Myocardial fiber diameter index was 9.1+/-1.2 (A) versus 12.3+/-1.4 (B), P<0.01, and 8.4+/-1.3 micrometer/m(2) (C), P<0.01. In parallel to the development of LVH at B, gene expression was increased significantly for MMP-1, MMP-2, MMP-3, and MMP-9 and for TIMP-1 and TIMP-2 and decreased significantly for TIMP-3. After surgical correction (C), there was a complete regression of gene expression to baseline measures. CONCLUSIONS: Controlled induction of compensated LVH leads to significant increase in ECM gene expression. The regression of LVH after surgical therapy is associated with complete regression of ECM gene expression. However, no cause-and-effect relation could be demonstrated.

Prospectively randomized comparison of different mechanical aortic valves.

BACKGROUND: The aim of this prospectively randomized study was to evaluate the hemodynamic and functional outcomes after aortic valve replacement with 3 different bileaflet mechanical valves. METHODS AND RESULTS: Three hundred consecutive patients were randomly assigned to receive ATS (n=100), Carbomedics (n=100), or St Jude Medical Hemodynamic Plus (n=100) mechanical aortic valve replacement. There were no significant differences regarding patient age (average 61+/-8 years), body surface area (1.9+/-0.2 m(2)), left ventricular function (ejection fraction 0.59+/-0.17), and presence of aortic stenosis (90%, 89%, and 91%), respectively. All patients had postoperative as well as 6-month and 1-year follow-ups that included transthoracic echocardiography. Multivariate statistical analysis was performed. Implanted valve sizes were comparable at 24+/-2 (ATS), 23.7+/-1.6 (CM), and 23.6+/-1.9 (SJMHP) mm (NS). At 1-year follow-up, the following incidence of events was noted: death 3/1/1, all non-valve related; stroke 0/1/1; trivial transvalvular incompetence 3/3/2; paravalvular leak 2/3/2; and reoperation 0/1/1, respectively (NS). Transvalvular flow velocities were 2.5/2.6/2.4 m/s postoperatively (P:=0.03) and 2.4/2.4/2.3 m/s at 6-month follow-up, respectively (NS). There was a significant decrease in left ventricular mass for all patients but no significant differences among the groups. CONCLUSIONS: There are no clinically relevant differences among the tested bileaflet aortic valves. Regardless of valve type, there was a low complication rate. On the basis of these findings, all 3 bileaflet prostheses are well suited for aortic valve replacement.

Humoral immune response during coronary artery bypass grafting: A comparison of limited approach, "off-pump" technique, and conventional cardiopulmonary bypass.

BACKGROUND: The introduction of limited approaches to the heart and the avoidance of cardiopulmonary bypass (CPB) aim to reduce the invasiveness of CABG by decreasing the systemic release of inflammatory cytokines, such as tumor necrosis factor (TNF)-alpha, interleukin (IL)-6, and IL-8, as well as the anti-inflammatory agent IL-10. This study compares the humoral immune response in patients undergoing CABG with standard, minimally invasive, and "off-pump" techniques. METHODS AND RESULTS: Thirty patients were divided into 3 operative groups: full sternotomy approach plus CPB (group A); full sternotomy approach, off pump (group B); and limited left anterior thoracotomy, off pump (group C). Plasma levels of TNF-alpha receptors p55 and p75, IL 6, IL-8, and IL-10 were taken at baseline, during CPB, and at 4, 24, and 48 hours and 6 days after surgery. A significant increased release of activated complement factors C5a and C3d, IL-8, and IL-10 was observed in patients subjected to CPB (group A) during the initial period and for a short time after perfusion (P:<0.05). TNF-alpha receptors p55 and p75 showed a prolonged elevation (up to 48 hours) in the CPB group compared with the 2 off-pump groups. IL-6 showed no different release among the 3 surgical groups throughout the entire period. There was no significant difference in any parameter measured in relation to the type of operative approach. CONCLUSIONS: There is an inflammatory, as well as an anti-inflammatory, response during CABG that is related to the general surgical trauma. The release of immune mediators is enhanced by the use of CPB during various perioperative and postoperative phases. The type of operative approach did not influence this immune response.

Late bilateral diaphragmatic rupture: challenging diagnostic and surgical repair.

A 67-year-old man was referred to our department, after a vehicle accident, with multiple bone fractures and a left blunt diaphragmatic rupture. An emergency laparatomy was performed, and the left diaphragmatic defect directly sutured. Postoperatively, a delayed right diaphragmatic rupture occurred due to progressive inflammation and muscle devitalisation. The diagnosis was challenging because the right rupture became clinically evident later after extubation. Diaphragmatic reconstruction was performed through a right thoracotomy. A high index of suspicion should always be observed for missed or delayed bilateral diaphragmatic ruptures.

A new cryoablation device for surgical therapy of atrial fibrillation.

During the last years, atrial fibrillation was treated more and more by surgical ablation. Due to serious complications with the available devices, new tools were developed. We report on the first successful cryoablation procedure with a new device in a patient with a high-grade mitral valve insufficiency (III-IV) and paroxysmal atrial fibrillation.

Influence of venous drainage and hemofiltration on hypercirculatory instability after high volume crystalloid cardioplegia during coronary artery bypass surgery.

AIM: The etiology of hypercirculatory instability following cardiac surgery with cardiopulmonary bypass has not yet been completely investigated and its clinical impact remains unclear. This prospective study was undertaken in order to investigate the impact of the systemic infusion of high volume crystalloid cardioplegia on the incidence of hypercirculatory instability and inflammatory mediator release in patients undergoing coronary artery bypass grafting. METHODS: Forty patients with single-atrial cannulation (group A), 40 patients with single-atrial cannulation and intraoperative hemofiltration (group B), and 40 patients with bicaval cannulation and complete removal of the cardioplegic solution from the right atrium (group C) were analyzed for hemodynamic changes and inflammatory mediator release until the postoperative day 2. Myocardial protection was performed using 2,000 mL cold crystalloid cardioplegia. RESULTS: A higher incidence of hypercirculatory instability in group A (39.2%) and B (42.8 %) was noted when compared to group C (18%, P = 0.032). Cardiac index was lower in group C when compared with group A (P = 0.001; 95% CI: 4.1, 15.57) and group B (P = 0.02; 95% CI: 1.13, 15.25). Systemic vascular resistance was higher in group C when compared with group A (P = 0.0001; 95% CI: 7108.7, 3131) and group B (P < 0.005; 95% CI 7598.9; 2830.6). High levels of tumor necrosis factor alpha, interleukin-6, interleukin-8, interleukin-10, and intercellular adhesion molecule-1 with no significant differences between the groups were measured early postoperative. CONCLUSIONS: High volume crystalloid cardioplegia under use of single-atrial venous cannulation is associated with a higher incidence of hypercirculatory failure. Hemofiltration during cardiopulmonary bypass offers no benefit on the incidence of hypercirculatory instability and to the release of inflammatory mediators.

A core outcome set for all types of cardiac surgery effectiveness trials: a study protocol for an international eDelphi survey to achieve consensus on what to measure and the subsequent selection of measurement instruments.

BACKGROUND: Cardiovascular disease (CVD) is a major contributor to the burden of disease and the number one cause of death worldwide. From 1990 until today, more people died from coronary heart disease than from any other cause. CVD is regularly treated with minimally or non-minimally invasive off- or on-pump cardiothoracic surgery and several interventions related to the outcome of the surgical procedures have been evaluated in clinical trials, but heterogeneity in outcome reporting hinders comparison of interventions across trials and limits the ability of research synthesis. This problem is encountered with the introduction of core outcome sets (COSs), which should be measured and reported, as a minimum, in all clinical trials for a specific clinical field. METHODS/DESIGN: This study protocol describes the methods used to develop a COS for all types of cardiac surgery effectiveness trials. We aim to reach consensus on what to measure in an international three-round eDelphi exercise involving adult patients in need or after cardiothoracic surgery, cardiothoracic surgeons, cardiologists, anaesthesiologists, nursing staff and researchers with expertise in this particular field of medical research. Subsequently, outcome measurement instruments (how to measure) will be determined. Recommendations on COS development given by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative and the Outcome Measures in Rheumatology (OMERACT) Initiative were followed. DISCUSSION: The proposed COS aims to provide methodological guidance for future cardiothoracic surgical trials to ensure the comparability of effects of interventions across studies and enable research synthesis. This does not imply that primary outcomes should always and exclusively be those of the COS. However, to ensure the comparability of results across trials, the outcomes included in this COS should be considered for inclusion besides measuring trial-specific clinical endpoints.