Preoperative serum selenium predicts acute kidney injury after adult cardiac surgery.

BACKGROUND: The relationship between serum selenium (Se) and acute kidney injury after adult cardiac surgery (CSA-AKI) remains controversial. This study aimed to investigate the association of preoperative Se level with incident CSA-AKI. METHOD AND RESULTS: A retrospective cohort study was conducted on patients who underwent cardiac surgery. The primary outcome was incident CSA-AKI. Multivariable logistic regression models and natural cubic splines were used to estimate the association of Se levels and primary outcome. A total of 453 patient with a mean age of 62.97 years were included. Among all patients, 159 (35.1%) incident cases of CSA-AKI were identified. The level of preoperative Se concentration in patients with CSA-AKI was significant lower than that in patients without CSA-AKI. The higher preoperative Se level was significantly associated with decreased risk of CSA-AKI (adjusted OR 0.91, 95% CI: 0.87-0.99). Dose-response relationship curve revealed a nearly L-shape correlation between serum Se selenium levels and incident CSA-AKI. CONCLUSION: Our study suggested that a higher level of serum Se was significantly associated with lower risk of CSA-AKI. Further prospective studies are needed to clarify the causal relationship between serum Se level and incident CSA-AKI.

A novel manual therapy approach for managing acute interscapular pain following median sternotomy for open cardiac surgery: A clinical comparative analysis.

INTRODUCTION: Acute interscapular pain is a frequent postoperative complication observed in patients who have undergone median sternotomy. This study aimed to assess a novel approach to manual therapy utilizing the Regional Interdependence (RI) concept for managing interscapular pain in post-sternotomy patients. MATERIALS AND METHODS: In an observational study, a cohort of 60 consecutively admitted patients undergoing median sternotomy was enrolled. Data collection involved standardized clinical evaluations conducted at specific time points: prior to manual treatment (T0), following five manual treatments (T5), and at post-treatment days 10 (T10) and 30 (T30). The Experimental Group (EG) received manual treatment based on the RI concept, performed in a seated position to accommodate individual clinical conditions and surgical wound considerations. The Control Group (CG) received simulated treatment involving identical exercises to the EG but lacking the physiological or biomechanical stimulation. RESULTS: Among the initial 60 patients, 36 met the inclusion criteria, while 24 were excluded due to one or more exclusion criteria. Treatment outcomes revealed a statistically significant improvement in the EG compared to the CG, not only in terms of pain reduction but also in functional recovery and consequent disability reduction. DISCUSSION: The RI concept emerges as a potentially valuable therapeutic approach for addressing interscapular dysfunction, particularly in highly complex post-sternotomy patients. This study highlights the clinical relevance of the RI concept in the management of interscapular pain and highlights its potential utility in improving patient outcomes in the challenging context of sternotomy surgery.

Nonpharmacologic Therapies for Postoperative Pain in Cardiac Surgery: A Systematic Review.

OBJECTIVES: To search for studies that address the efficacy of nonpharmacologic methods for pain relief in adults undergoing cardiac surgeries. DESIGN: A systematic review registered in the International Prospective Register of Systematic Reviews (PROSPERO) under number CRD42020168681. DATA SOURCE: PubMed, LILACS, CINAHL, the Web of Science, Scopus, and the Cochrane Central Register of Controlled Trials. REVIEW/ANALYSIS METHODS: The review used a PRISMA guideline that selected primary randomized controlled trials on the efficacy of nonpharmacologic pain relief therapies in patients undergoing cardiac surgery, with no time or language restrictions. The Joanna Briggs Institute Critical Appraisal Checklist for Randomized Clinical Trials was used to assess methodological rigor. RESULTS: After screening, 23 of the 140 studies found in the databases were selected. The studies examined the efficacy of 13 different nonpharmacologic therapies, as well as a combination of therapies, with massage therapy being the most commonly examined, followed by musical intervention and hypnosis. CONCLUSIONS: Some interventions, when combined with pharmacologic therapy, were effective in relieving postoperative pain after cardiac surgeries, according to the studies analyzed. However, most studies had significant methodological flaws, and further studies with high methodological quality are needed.

Efficacy of Respiratory Muscle Training in the Immediate Postoperative Period of Cardiac Surgery: A Systematic Review and Meta-Analysis.

INTRODUCTION: This study aimed to evaluate the efficacy of respiratory muscle training during the immediate postoperative period of cardiac surgery on respiratory muscle strength, pulmonary function, functional capacity, and length of hospital stay. METHODS: This is a systematic review and meta-analysis. A comprehensive search on PubMed®, Excerpta Medica Database (or Embase), Cumulative Index of Nursing and Allied Health Literature (or CINAHL), Latin American and Caribbean Health Sciences Literature (or LILACS), Scientific Electronic Library Online (or SciELO), Physiotherapy Evidence Database (or PEDro), and Cochrane Central Register of Controlled Trials databases was performed. A combination of free-text words and indexed terms referring to cardiac surgery, coronary artery bypass grafting, respiratory muscle training, and clinical trials was used. A total of 792 studies were identified; after careful selection, six studies were evaluated. RESULTS: The studies found significant improvement after inspiratory muscle training (IMT) (n = 165, 95% confidence interval [CI] 9.68, 21.99) and expiratory muscle training (EMT) (n = 135, 95% CI 8.59, 27.07) of maximal inspiratory pressure and maximal expiratory pressure, respectively. Also, IMT increased significantly (95% CI 19.59, 349.82, n = 85) the tidal volume. However, no differences were found in the peak expiratory flow, functional capacity, and length of hospital stay after EMT and IMT. CONCLUSION: IMT and EMT demonstrated efficacy in improving respiratory muscle strength during the immediate postoperative period of cardiac surgery. There was no evidence indicating the efficacy of IMT for pulmonary function and length of hospital stay and the efficacy of EMT for functional capacity.

Efficacy of electroacupuncture on myocardial protection and postoperative rehabilitation in patients undergoing cardiac surgery with cardiopulmonary bypass: a systematic review and Meta-analysis.

OBJECTIVE: To evaluate the efficacy of electroacupuncture (EA) intervention on myocardial protection and postoperative rehabilitation in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). METHODS: Eight databases, including PubMed, Embase, the Cochrane Library, Web of Science, Chinese BioMedical Literature Database, China National Knowledge Infrastructure Database, Wanfang Data, China Science and Technology Journal Database, and two clinical trial registries, were searched. All randomized controlled trials (RCTs) related to EA intervention in cardiac surgery with CPB were collected. Based on the inclusion and exclusion criteria, two researchers independently screened articles and extracted data. After the quality evaluation, RevMan 5.3 software was used for analysis. RESULTS: Fourteen RCTs involving 836 patients were included. Compared with the control treatment, EA significantly increased the incidence of cardiac automatic rebeat after aortic unclamping [relative risk (RR) = 1.15, 95% confidence interval (CI) (1.01, 1.31), P < 0.05; moderate]. Twenty-four hours after aortic unclamping, EA significantly increased the superoxide dismutase [standardized mean difference (SMD) = 0.96, 95% CI(0.32, 1.61), P < 0.05; low], and interleukin (IL)-2 [SMD = 1.33, 95% CI(0.19, 2.47), P < 0.05; very low] expression levels and decreased the malondialdehyde [SMD =－1.62, 95% CI(－2.15, －1.09), P < 0.05; moderate], tumour necrosis factor-α [SMD = －1.28, 95% CI(－2.37, －0.19), P < 0.05; moderate], and cardiac troponin I [SMD = －1.09, 95% CI(－1.85, －0.32), P < 0.05; low] expression levels as well as the inotrope scores [SMD = －0.77, 95% CI(－1.22, －0.31), P < 0.05; high]. There was no difference in IL-6 and IL-10 expression levels. The amount of intraoperative sedative [SMD = -0.31, 95% CI(－0.54, －0.09), P < 0.05; moderate] and opioid analgesic [SMD = -0.96, 95% CI(－1.53, －0.38), P < 0.05; low] medication was significantly lower in the EA group than in the control group. Moreover, the postoperative tracheal intubation time [SMD = －0.92, 95% CI(－1.40, －0.45), P < 0.05; low] and intensive care unit stay [SMD = －1.71, 95% CI(－3.06, －0.36), P < 0.05; low] were significantly shorter in the EA group than in the control group. There were no differences in the time to get out of bed for the first time, total days of antibiotic use after surgery, or postoperative hospital stay. No adverse reactions related to EA were reported in any of the included studies. CONCLUSIONS: In cardiac surgery with CPB, EA may be a safe and effective strategy to reduce myocardial ischaemia-reperfusion injury and speed up the recovery of patients after surgery. These findings must be interpreted with caution, as most of the evidence was of low or moderate quality. More RCTs with larger sample sizes and higher quality are needed to provide more convincing evidence.

Removal of Wires for Sternal Internal Fixation After Cardiac Surgery in Adolescents.

Objective: The objective of this study was to assess the safety and patient satisfaction of sternal wire removal surgery, rendering reference for clinical practice in the future. Methods: A total of 70 adolescent patients with completely healed sternum and no other diseases or able to receive surgery were randomly selected and subjected to sternal wire removal surgery. Besides, relevant data including patient age, gender, wire rupture, reason for wire removal, postoperative wire residuals, patient satisfaction, age at cardiac surgery, waiting time after cardiac surgery, and removal duration were recorded. Results: Raptured wire group exhibited higher proportions of males and chest pain cases and longer operative time than unruptured wire group. The demand for wire removal had no relation to gender, but patients receiving surgery due to chest pain were mainly aged 12-15 years old, those undergoing surgery due to employment and further education were mainly aged 9-12 years old, and those subjected to surgery sue to ruptures found in physical examinations were mainly aged 6-9 years old. According to statistics of wire rupture position, the rupture of the 4th wire accounted for the largest proportion, and rupture of multiple wires was found in some patients. No statistically significant differences were found in gender, age, age at cardiac surgery, and waiting time after cardiac surgery between patients with only one wire ruptured and those with multiple wires ruptured. Patients were grouped based on the absence and presence of chest pain, and it was found that chest pain group had a longer removal duration, but comparable age at cardiac surgery and waiting time after cardiac surgery, and the waiting time after cardiac surgery was a risk factor for chest pain. The waiting time after cardiac surgery was positively correlated with operative time, so we recommend that if there were symptoms of chest discomfort, it should be removed as soon as possible. However, due to the needs of the patients, no control group was set up, which is the limitation of this study. In the next step, we will conduct more long-term observation of the patients to confirm whether the chest pain can be relieved by itself without removing the wire. Conclusion: This study found that for adolescent patients with chest pain or other life troubles after cardiac surgery, removing the sternal internal fixation wire can quickly and effectively relieve the troubles, and is a safe and reliable treatment means. Therefore, if it is necessary to remove the wire, it should be removed as soon as possible to avoid wire breakage and increase the difficulty of surgery.

Dynamic changes of serum trace elements following cardiac surgery: A systematic review and meta-analysis.

BACKGROUND: Cardiac surgeries are known to induce an inflammatory response. Besides, dietary factors such as trace elements contribute to promoting cardiovascular health by maintaining oxidative balance. Here we systematically review the literature about alterations in serum concentrations of zinc (Zn), copper (Cu), and selenium (Se) in response to cardiac surgeries. METHODS: A systematic search was performed on databases until the end of December 2022. Studies assessing the changes of mentioned elements in adult patients undergoing cardiac surgery were included. Changes in the means and standard deviations of the elements before and after the cardiac surgery were utilized as desired effect sizes. RESULTS: Among 1252 records found in the primary search, 23 and 21 articles were included in the systematic review and meta-analysis respectively. Seventeen studies evaluated the changes in serum Zn and Cu levels, and fifteen studies assessed Se levels. According to the results of quantitative analysis, Zn, Cu, and Se concentrations, one day after the surgery were significantly lower than preoperative values (WMD for Zn: 4.64 µmol/L [3.57-5.72], WMD for Cu: 1.62 µmol/L [0.52-2.72], and WMD for Se: 0.1 µmol/L [0.03-0.16]). The concentration of trace elements recovered gradually during the first-week post-operation and reached preoperative levels or even higher. CONCLUSION: Serum trace elements dropped significantly soon after the cardiac surgery, but they reached their baseline levels mostly during the first week after the surgery. Future studies are warranted to elucidate the impact of alterations in serum concentration of trace elements on the outcomes and complications of open-heart surgeries.

High density mapping of atrial tachycardia in patients post cardiac surgery.

Mapping and ablation of atrial tachycardia (AT) in patients who have had prior cardiac surgery can be a challenge for clinical electrophysiologists. High density mapping (HDM) technology has been widely used in these patients because it provides a better characterization of the substrate and the mechanisms with an unprecedented high resolution. In this review, we summarize how the latest HDM technologies can reveal the mechanism of AT in different types of patients post-cardiac surgery and guide a specifically tailored ablation strategy.

High density mapping of complex atrial tachycardia in patients after cardiac surgery.

To provide an overview of the current application of high-density mapping (HDM) in the mechanism of complex atrial tachycardias (ATs). Complex ATs are frequently scar-related, after history of previous cardiac surgery and large scars. These scar-related ATs are difficult to manage medically and frequently recur after electrical cardioversion. HDM technologies have enabled rigorous elucidation of AT mechanisms in patients post cardiac surgery. This article showed the application of HDM technology in complex ATs from the mechanisms of complex ATs, the development of HDM technology, and the identification of scars or critical isthmus from HDM. HDM-guided approach is highly effective for identifying the ATs mechanism and critical isthmus.

Recommendations for Centers Performing Pediatric Heart Surgery in the United States.

Care and outcomes for the more than 40,000 patients undergoing pediatric and congenital heart surgery in the United States annually are known to vary widely. While consensus recommendations have been published across numerous fields as one mechanism to promote a high level of care delivery across centers, it has been more than two decades since the last pediatric heart surgery recommendations were published in the United States. More recent guidance is lacking, and collaborative efforts involving the many disciplines engaged in caring for these children have not been undertaken to date. The present initiative brings together professional societies spanning numerous care domains and congenital cardiac surgeons, pediatric cardiologists, nursing, and other healthcare professionals from diverse programs around the country to develop consensus recommendations for United States centers. The focus of this initial work is on pediatric heart surgery, and it is recommended that future efforts focus in detail on the adult congenital population. We describe the background, rationale, and methodology related to this collaborative effort, and recommendations put forth for Essential Care Centers (essential services necessary for any program), and Comprehensive Care Centers (services to optimize comprehensive and high-complexity care), encompassing structure, process, and outcome metrics across 14 domains.

Recommendations for centers performing pediatric heart surgery in the United States.

Care and outcomes for the more than 40,000 patients undergoing pediatric and congenital heart surgery in the United States annually are known to vary widely. While consensus recommendations have been published across numerous fields as one mechanism to promote a high level of care delivery across centers, it has been more than two decades since the last pediatric heart surgery recommendations were published in the United States. More recent guidance is lacking, and collaborative efforts involving the many disciplines engaged in caring for these children have not been undertaken to date. The present initiative brings together professional societies spanning numerous care domains and congenital cardiac surgeons, pediatric cardiologists, nursing, and other healthcare professionals from diverse programs around the country to develop consensus recommendations for United States centers. The focus of this initial work is on pediatric heart surgery, and it is recommended that future efforts focus in detail on the adult congenital population. We describe the background, rationale, and methodology related to this collaborative effort, and recommendations put forth for Essential Care Centers (essential services necessary for any program), and Comprehensive Care Centers (services to optimize comprehensive and high-complexity care), encompassing structure, process, and outcome metrics across 14 domains.

Effects of yoga on anxiety, pain, inflammatory and stress biomarkers in patients undergoing cardiac surgery: A systematic review and meta-analysis.

BACKGROUND: The most common surgical method of managing coronary artery disease is coronary artery bypass grafting (CABG). Stress, anxiety, and pain are commonly identified postoperative symptoms and are closely correlated to patient recovery. OBJECTIVE: The purpose of this review was to investigate the effects of yoga interventions on anxiety, pain, inflammatory and stress biomarkers in CABG surgery patients. METHODS: and analysis: The databases PUBMED, The Cochrane CENTRAL, EMBASE, CINAHL, Scopus, and Web of Science were comprehensively searched from the inception to December 2022. The quantitative research studies that evaluated the effects of yoga on anxiety, pain, inflammatory and stress biomarkers in CABG patients were included. This systematic review and meta-analysis followed the Cochrane guidelines and is reported using the PRISMA checklist. The RevMan 5.4 software was used for the meta-analysis. RESULTS: Seventeen studies met the inclusion criteria, representing 1227 patients with a mean age of 58 years. All studies have reported that yoga interventions significantly reduced anxiety, pain, inflammatory and stress biomarkers in the experimental group compared to the control group. According to the GRADE criteria, moderate quality of evidence was found on effects of yoga intervention in CABG surgery patients. CONCLUSION: Yoga has been shown to benefit patients undergoing CABG surgery. It can be used as an adjunctive intervention. However, more rigorous randomized controlled trials are required to generate high-quality evidence for yoga interventions. REGISTRATION: PROSPERO CRD42020175833.

Recommendations for Centers Performing Pediatric Heart Surgery in the United States.

Care and outcomes for the more than 40,000 patients undergoing pediatric and congenital heart surgery in the United States annually are known to vary widely. While consensus recommendations have been published across numerous fields as one mechanism to promote a high level of care delivery across centers, it has been more than two decades since the last pediatric heart surgery recommendations were published in the United States. More recent guidance is lacking, and collaborative efforts involving the many disciplines engaged in caring for these children have not been undertaken to date. The present initiative brings together professional societies spanning numerous care domains and congenital cardiac surgeons, pediatric cardiologists, nursing, and other healthcare professionals from diverse programs around the country to develop consensus recommendations for United States centers. The focus of this initial work is on pediatric heart surgery, and it is recommended that future efforts focus in detail on the adult congenital population. We describe the background, rationale, and methodology related to this collaborative effort, and recommendations put forth for Essential Care Centers (essential services necessary for any program), and Comprehensive Care Centers (services to optimize comprehensive and high-complexity care), encompassing structure, process, and outcome metrics across 14 domains.

Investigation of the Effects of Acupuncture on Post-Operative Chest Pain after Open Heart Surgery.

Background: Coronary artery bypass grafting (CABG) accounts for more than half of all adult cardiac surgeries worldwide. Post-operative chest pain is a common CABG complication and can cause significant discomfort. Objectives: Because taking large amounts of analgesics can have many side effects, we evaluated whether acupuncture effectively reduces pain and the use of analgesics by CABG patients. Methods: In this clinical trial, 30 patients who had recently undergone CABG were randomly allocated to two groups. For both groups, exercise therapy and routine analgesics were recommended. The intervention group underwent bilateral acupuncture in distinct acupoints, including the HT3, HT4, HT5, HT6, HT7, PC3, PC5, PC6, and PC7 for 10 daily sessions constantly. Visual analog scale (VAS) and analgesic use were evaluated in both groups at baseline and after completing the 10-day treatment. Results: Our analysis revealed significant decreases in the mean VAS scores in both the intervention and the control group, and that the reduction was more significant in the acupuncture group (p < 0.001). Moreover, analgesic use was significantly lower in the acupuncture group when compared with the control group (p < 0.001). Conclusion: Our findings highlight acupuncture as an alternative method of controlling CABG-associated post-operative chest pain and reducing the use of analgesics, which might have many side effects.

Brazilian Adults' Hope and Spirituality in Preoperative Heart Surgery: A Cross-Sectional Study.

INTRODUCTION: Given the incipience of domestic studies on hope and spirituality in cardiology, this study evaluated adult cardiac patients' hope in the preoperative period of cardiac surgery and its potential association with spirituality. METHODS: This is a cross-sectional study carried out at a university hospital in the State of São Paulo (Brazil). A total of 70 patients answered the Herth Hope Scale and a sociodemographic questionnaire before undergoing surgical procedure between January and October 2018. Descriptive and inferential analyses were performed using the Spearman's rank correlation coefficient and the Mann-Whitney U test. The R-3.4.1 software and SAS System for Windows 9.2 were also used. P-value < 0.05 was considered statistically significant. RESULTS: Patients had a high prevalence of modifiable risk factors. Having a religion (37.53±4.57) and practicing it (38.79±4.25), regardless of its denomination and time dedicated to that religion, was associated with hope (P<0.01) in the immediate preoperative period of cardiac surgery. However, hope did not exhibit a significant correlation with factors such as age (P=0.09) and time dedicated to religious practice (P=0.07). CONCLUSION: Regardless of the religious strand and time dedicated to religious practices as an expression of spirituality, hope was associated with the participants' religion and religiosity. Considering the importance of this construct on the processes of health and disease, the whole health team should consider in their praxis a setting of conditions to make the patient's spirituality process feasible during hospitalization.

Turbulence in surgical suction heads as detected by MRI.

BACKGROUND: Blood loss is common during surgical procedures, especially in open cardiac surgery. Allogenic blood transfusion is associated with increased morbidity and mortality. Blood conservation programs in cardiac surgery recommend re-transfusion of shed blood directly or after processing, as this decreases transfusion rates of allogenic blood. But aspiration of blood from the wound area is often associated with increased hemolysis, due to flow induced forces, mainly through development of turbulence. METHODS: We evaluated magnetic resonance imaging (MRI) as a qualitative tool for detection of turbulence. MRI is sensitive to flow; this study uses velocity-compensated T1-weighted 3D MRI for turbulence detection in four geometrically different cardiotomy suction heads under comparable flow conditions (0-1250 mL/min). RESULTS: Our standard control suction head Model A showed pronounced signs of turbulence at all flow rates measured, while turbulence was only detectable in our modified Models 1-3 at higher flow rates (Models 1 and 3) or not at all (Model 2). CONCLUSIONS: The comparison of flow performance of surgical suction heads with different geometries via acceleration-sensitized 3D MRI revealed significant differences in turbulence development between our standard control Model A and the modified alternatives (Models 1-3). As flow conditions during measurement have been comparable, the specific geometry of the respective suction heads must have been the main factor responsible. The underlying mechanisms and causative factors can only be speculated about, but as other investigations have shown, hemolytic activity is positively associated with degree of turbulence. The turbulence data measured in this study correlate with data from other investigations about hemolysis induced by surgical suction heads. The experimental MRI technique used showed added value for further elucidating the underlying physical phenomena causing blood damage due to non-physiological flow.

Utilizing retrograde autologous priming for blood conservation in cardiac surgery.

BACKGROUND: The use of crystalloid priming for extracorporeal circuit in adult cardiac surgery causes inevitable haemodilution. The haemodilution can be reduced by using methods such as retrograde autologous priming (RAP) with the patient's blood. This study compares the RAP technique with standard priming with regards to safety and the impact on haemodilution. METHODS: This was a retrospective cohort study between a control group (n = 100) consisting of consecutive patients undergoing first time isolated coronary artery bypass surgery (CABG) with crystalloid priming solution in the circuit, and the RAP group (n = 100) consisting of patients undergoing isolated first time CABG with the RAP method. All demographics, procedure and perfusion data were gathered from the local surgical and perfusion database. RESULTS: Despite starting with comparable mean pre-operative haemoglobin (Hb) levels (control 127 mg/dL versus RAP 129 mg/dL), the RAP group had significantly higher mean post-op Hb level (109 mg/dL versus 92 mg/dL, P < 0.01). Crystalloid use was also significantly lower in RAP group (3.15 L versus 4.17 L P < 0.02). Freedom from red blood cell transfusion (86% versus 76% P = 0.038) and freedom from blood products (78% versus 66%, P = 0.032) was also significantly better in the RAP group. CONCLUSIONS: This study demonstrates that retrograde autologous priming is a safe and effective method for priming the cardiopulmonary bypass circuit in adult cardiac surgery, with significantly beneficial effects on transfusion rates and intra operative fluid requirements. Given these results the RAP method should be considered as a routine step in priming an extracorporeal circuit for adult cardiac operations.

Combined Platelet and Red Blood Cell Recovery during On-pump Cardiac Surgery Using same™ by i-SEP Autotransfusion Device: A First-in-human Noncomparative Study (i-TRANSEP Study).

BACKGROUND: Centrifugation-based autotransfusion devices only salvage red blood cells while platelets are removed. The same™ device (Smart Autotransfusion for ME; i-SEP, France) is an innovative filtration-based autotransfusion device able to salvage both red blood cells and platelets. The authors tested the hypothesis that this new device could allow a red blood cell recovery exceeding 80% with a posttreatment hematocrit exceeding 40%, and would remove more than 90% of heparin and 75% of free hemoglobin. METHODS: Adults undergoing on-pump elective cardiac surgery were included in a noncomparative multicenter trial. The device was used intraoperatively to treat shed and residual cardiopulmonary bypass blood. The primary outcome was a composite of cell recovery performance, assessed in the device by red blood cell recovery and posttreatment hematocrit, and of biologic safety assessed in the device by the washout of heparin and free hemoglobin expressed as removal ratios. Secondary outcomes included platelet recovery and function and adverse events (clinical and device-related adverse events) up to 30 days after surgery. RESULTS: The study included 50 patients, of whom 18 (35%) underwent isolated coronary artery bypass graft, 26 (52%) valve surgery, and 6 (12%) aortic root surgery. The median red blood cell recovery per cycle was 86.1% (25th percentile to 75th percentile interquartile range, 80.8 to 91.6) with posttreatment hematocrit of 41.8% (39.7 to 44.2). Removal ratios for heparin and free hemoglobin were 98.9% (98.2 to 99.7) and 94.6% (92.7 to 96.6), respectively. No adverse device effect was reported. Median platelet recovery was 52.4% (44.2 to 60.1), with a posttreatment concentration of 116 (93 to 146) · 109/l. Platelet activation state and function, evaluated by flow cytometry, were found to be unaltered by the device. CONCLUSIONS: In this first-in-human study, the same™ device was able to simultaneously recover and wash both platelets and red blood cells. Compared with preclinical evaluations, the device achieved a higher platelet recovery of 52% with minimal platelet activation while maintaining platelet ability to be activated in vitro.

Preclinical safety and biodistribution assessment of Ad-KCNH2-G628S administered via atrial painting in New Zealand white rabbits.

Post-operative atrial fibrillation (POAF) is the most common complication after cardiac surgery. Despite implementation of several pharmacological strategies, incidence of POAF remains at approximately 30%. An adenovirus vector encoding KCNH2-G628S has proven efficacious in a porcine model of AF. In this preclinical study, 1.5 × 1010 or 1.5 × 1012 Ad-KCNH2-G628S vector particles (vp) were applied to the atrial epicardium or 1.5 × 1012 vp were applied to the whole epicardial surface of New Zealand White rabbits. Saline and vector vehicle served as procedure controls. Animals were followed for up to 42 days. Vector genomes persisted in the atria up to 42 days, with no distribution to extra-thoracic organs. There were no adverse effects attributable to test article on standard toxicological endpoints or on blood pressure, left atrial or ventricular ejection fractions, electrocardiographic parameters, or serum IL-6 or troponin concentrations. Mononuclear infiltration of the myocardium of the atrial free walls of low-dose, but not high-dose animals was observed at 7 and 21 days, but these changes did not persist or affect cardiac function. After scaling for heart size, results indicate the test article is safe at doses up to 25 times the maximum proposed for the human clinical trial.