In a phase 2 trial, patients with mechanical heart valves were randomly assigned to receive either dabigatran or warfarin for anticoagulation. Dabigatran was associated with higher rates of ischemic ...stroke (5%, vs. 0% with warfarin) and major bleeding (4% vs. 2%).
Prosthetic heart-valve replacement is recommended for many patients with severe valvular heart disease and is performed in several hundred thousand patients worldwide each year.
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Mechanical valves are more durable than bioprosthetic valves
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but typically require lifelong anticoagulant therapy. The use of vitamin K antagonists provides excellent protection against thromboembolic complications in patients with mechanical heart valves
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but requires restrictions on food, alcohol, and drugs and lifelong coagulation monitoring. Because of the limitations of vitamin K antagonists, many patients opt for a bioprosthesis rather than a mechanical valve, despite the higher risk of premature valve failure requiring repeat valve-replacement surgery with . . .
About 3,000 individuals in the United States are awaiting a donor heart; worldwide, 22 million individuals are living with heart failure. A bioartificial heart is a theoretical alternative to ...transplantation or mechanical left ventricular support. Generating a bioartificial heart requires engineering of cardiac architecture, appropriate cellular constituents and pump function. We decellularized hearts by coronary perfusion with detergents, preserved the underlying extracellular matrix, and produced an acellular, perfusable vascular architecture, competent acellular valves and intact chamber geometry. To mimic cardiac cell composition, we reseeded these constructs with cardiac or endothelial cells. To establish function, we maintained eight constructs for up to 28 d by coronary perfusion in a bioreactor that simulated cardiac physiology. By day 4, we observed macroscopic contractions. By day 8, under physiological load and electrical stimulation, constructs could generate pump function (equivalent to about 2% of adult or 25% of 16-week fetal heart function) in a modified working heart preparation.
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DOBA, IJS, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
Cardiopulmonary bypass (CPB) surgery initiates a systemic inflammatory response, which is associated with postoperative morbidity and mortality. Hemoadsorption (HA) of cytokines may suppress ...inflammatory responses and improve outcomes. We tested a new sorbent used for HA (CytoSorb™; CytoSorbents Europe GmbH, Berlin, Germany) installed in the CPB circuit on changes of pro- and anti-inflammatory cytokines levels, inflammation markers, and differences in patients' perioperative course.
In this first pilot trial, 37 blinded patients were undergoing elective CPB surgery at the Medical University of Vienna and were randomly assigned to HA (n = 19) or control group (n = 18). The primary outcome was differences of cytokine levels (IL-1β, IL-6, IL-18, TNF-α, and IL-10) within the first five postoperative days. We also analyzed whether we can observe any differences in ex vivo lipopolysaccharide (LPS)-induced TNF-α production, a reduction of high-mobility box group 1 (HMGB1), or other inflammatory markers. Additionally, measurements for fluid components, blood products, catecholamine treatment, bioelectrical impedance analysis (BIA), and 30-day mortality were analyzed.
We did not find differences in our primary outcome immediately following the HA treatment, although we observed differences for IL-10 24 hours after CPB (HA: median 0.3, interquartile range (IQR) 0-4.5; control: not traceable, P = 0.0347) and 48 hours after CPB (median 0, IQR 0-1.2 versus not traceable, P = 0.0185). We did not find any differences for IL-6 between both groups, and other cytokines were rarely expressed. We found differences in pretreatment levels of HMGB1 (HA: median 0, IQR 0-28.1; control: median 48.6, IQR 12.7-597.3, P = 0.02083) but no significant changes to post-treatment levels. No differences in inflammatory markers, fluid administration, blood substitution, catecholamines, BIA, or 30-day mortality were found.
We did not find any reduction of the pro-inflammatory response in our patients and therefore no changes in their perioperative course. However, IL-10 showed a longer-lasting anti-inflammatory effect. The clinical impact of prolonged IL-10 needs further evaluation. We also observed strong inter-individual differences in cytokine levels; therefore, patients with an exaggerated inflammatory response to CPB need to be identified. The implementation of HA during CPB was feasible.
ClinicalTrials.gov: NCT01879176, registration date: June 7, 2013.
Pulse pressure variation (PPV) has been widely used in hemodynamic assessment. Nevertheless, PPV is limited in low tidal volume ventilation. We conducted this systematic review and meta-analysis to ...evaluate whether the tidal volume challenge (TVC) could improve the feasibility of PPV in patients ventilated at low tidal volumes.
PubMed, Embase and Cochrane Library inception to October 2022 were screened for diagnostic researches relevant to the predictability of PPV change after TVC in low tidal volume ventilatory patients. Summary receiving operating characteristic curve (SROC), pooled sensitivity and specificity were calculated. Subgroup analyses were conducted for possible influential factors of TVC.
Ten studies with a total of 429 patients and 457 measurements were included for analysis. The predictive performance of PPV was significantly lower than PPV change after TVC in low tidal volume, with mean area under the receiving operating characteristic curve (AUROC) of 0.69 ± 0.13 versus 0.89 ± 0.10. The SROC of PPV change yielded an area under the curve of 0.96 (95% CI 0.94, 0.97), with overall pooled sensitivity and specificity of 0.92 (95% CI 0.83, 0.96) and 0.88 (95% CI 0.76, 0.94). Mean and median cutoff value of the absolute change of PPV (△PPV) were 2.4% and 2%, and that of the percentage change of PPV (△PPV%) were 25% and 22.5%. SROC of PPV change in ICU group, supine or semi-recumbent position group, lung compliance less than 30 cm H
O group, moderate positive end-expiratory pressure (PEEP) group and measurements devices without transpulmonary thermodilution group yielded 0.95 (95%0.93, 0.97), 0.95 (95% CI 0.92, 0.96), 0.96 (95% CI 0.94, 0.97), 0.95 (95% CI 0.93, 0.97) and 0.94 (95% CI 0.92, 0.96) separately. The lowest AUROCs of PPV change were 0.59 (95% CI 0.31, 0.88) in prone position and 0.73 (95% CI 0.60, 0.84) in patients with spontaneous breathing activity.
TVC is capable to help PPV overcome limitations in low tidal volume ventilation, wherever in ICU or surgery. The accuracy of TVC is not influenced by reduced lung compliance, moderate PEEP and measurement tools, but TVC should be cautious applied in prone position and patients with spontaneous breathing activity. Trial registration PROSPERO (CRD42022368496). Registered on 30 October 2022.
Cardiogenic shock (CS) is associated with hemodynamic compromise and end-organ hypoperfusion due to a primary cardiac etiology. In addition to vasoactive medications, percutaneous mechanical ...circulatory support (MCS) devices offer the ability to support the hemodynamics and prevent acute organ failure. Despite the wide array of available MCS devices for CS, there are limited data on the complications from these devices. In this review, we seek to summarize the complications of MCS devices in the contemporary era. Using a systems-based approach, this review covers domains of hematological, neurological, vascular, infectious, mechanical, and miscellaneous complications. These data are intended to provide a balanced narrative and aid in risk–benefit decision-making in this acutely ill population.
A practical artificial heart has been sought for >50 years. An increasing number of people succumb to heart disease each year, but the number of hearts available for transplantation remains small. ...Early total artificial hearts mimicked the pumping action of the native heart. These positive-displacement pumps could provide adequate haemodynamic support and maintain the human circulation for short periods, but large size and limited durability adversely affected recipients' quality of life. Subsequent research into left ventricular assist devices led to the use of continuous-flow blood pumps with rotating impellers. Researchers have attempted to integrate this technology into modern total artificial hearts with moderate clinical success. The importance of pulsatile circulation remains unclear. Future research is, therefore, needed into positive-displacement and rotary total artificial hearts.
Mechanical left ventricular assist devices have been used as a bridge to cardiac transplantation, but not as long-term therapy. In this study of patients with severe heart failure who were not ...candidates for transplantation, left ventricular assist was compared with optimal medical therapy. The one-year survival rate was 52 percent in the device group and 25 percent in the medical-therapy group. The device permitted patients to be ambulatory and improved the quality of life.
In this study of patients with severe heart failure who were not candidates for transplantation, left ventricular assist was compared with optimal medical therapy. This study is an important step in the further development of artificial-heart technology.
Improving the survival and the quality of life of patients with end-stage heart failure has been the underlying goal of decades of research on mechanical circulatory-support devices. This effort was stimulated by the increasing prevalence of this disorder and its grave prognosis. Heart failure affects an estimated 4.7 million Americans, with 550,000 new cases diagnosed annually and annual cost estimates ranging from $10 billion to $40 billion.
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,
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The aggregate five-year survival rate of patients with heart failure is approximately 50 percent,
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whereas the one-year mortality rate of those with advanced disease may exceed 50 percent.
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Patients with mild-to-moderate heart . . .
ABSTRACT BACKGROUND Perioperative corticosteroid use may reduce acute kidney injury. We sought to test whether methylprednisolone reduces the risk of acute kidney injury after cardiac surgery. ...METHODS We conducted a prespecified substudy of a randomized controlled trial involving patients undergoing cardiac surgery with cardiopulmonary bypass (2007–2014); patients were recruited from 79 centres in 18 countries. Eligibility criteria included a moderate-to-high risk of perioperative death based on a preoperative score of 6 or greater on the European System for Cardiac Operative Risk Evaluation I. Patients ( n = 7286) were randomly assigned (1:1) to receive intravenous methylprednisolone (250 mg at anesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients, caregivers, data collectors and outcome adjudicators were unaware of the assigned intervention. The primary outcome was postoperative acute kidney injury, defined as an increase in the serum creatinine concentration (from the preoperative value) of 0.3 mg/dL or greater (≥ 26.5 μmol/L) or 50% or greater in the 14-day period after surgery, or use of dialysis within 30 days after surgery. RESULTS Acute kidney injury occurred in 1479/3647 patients (40.6%) in the methylprednisolone group and in 1426/3639 patients (39.2%) in the placebo group (adjusted relative risk 1.04, 95% confidence interval 0.96 to 1.11). Results were consistent across several definitions of acute kidney injury and in patients with preoperative chronic kidney disease. INTERPRETATION Intraoperative corticosteroid use did not reduce the risk of acute kidney injury in patients with a moderate-to-high risk of perioperative death who had cardiac surgery with cardiopulmonary bypass. Our results do not support the prophylactic use of steroids during cardiopulmonary bypass surgery. Trial registration: ClinicalTrials.gov , no. NCT00427388
Coronary artery disease (CAD) is the most common cause of death globally. Patients with suspected CAD are usually assessed by exercise electrocardiography (ECG). Subsequent tests, such as coronary ...angiography and coronary computed tomography angiography (CCTA) are performed to localize the stenosis and to estimate the degree of blockage. The present study describes a non-invasive methodology to identify patients with CAD based on the analysis of both rest and exercise seismocardiography (SCG). SCG is a non-invasive technology for capturing the acceleration of the chest induced by myocardial motion and vibrations. SCG signals were recorded from 185 individuals at rest and immediately after exercise. Two models were developed using the characterization of the rest and exercise SCG signals to identify individuals with CAD. The models were validated against related results from angiography. For the rest model, accuracy was 74%, and sensitivity and specificity were estimated as 75 and 72%, respectively. For the exercise model accuracy, sensitivity, and specificity were 81, 82, and 84%, respectively. The rest and exercise models presented a bootstrap-corrected area under the curve of 0.77 and 0.91, respectively. The discrimination slope was estimated 0.32 for rest model and 0.47 for the exercise model. The difference between the discrimination slopes of these two models was 0.15 (95% CI: 0.10 to 0.23,
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< 0.0001). Both rest and exercise models are able to detect CAD with comparable accuracy, sensitivity, and specificity. Performance of SCG is better compared to stress-ECG and it is identical to stress-echocardiography and CCTA. SCG examination is fast, inexpensive, and may even be carried out by laypersons.
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